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C.R.C., c. 870
FOOD AND DRUGS ACT
Regulations Respecting Food and Drugs
PART A
Administration
General
A.01.001 These Regulations may be cited as the Food and Drug Regulations.
A.01.002 These Regulations, where applicable, prescribe the standards of composition, strength, potency, purity, quality or other property of the article of food or drug to which they refer.
A.01.003 [Repealed, SOR/94-289, s. 1]
Interpretation
A.01.010 In these Regulations,
acceptable method
acceptable method means a method of analysis or examination designated by the Director as acceptable for use in the administration of the Act and these Regulations; (méthode acceptable)
Act
Act means the Food and Drugs Act, except in Parts G and J; (Loi)
common-law partner
common-law partner, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year; (conjoint de fait)
cubic centimetre
cubic centimetre and its abbreviation cc. shall be deemed to be interchangeable with the term millilitre and its abbreviation ml.; (centimètre cube)
Director
Director means the Assistant Deputy Minister, Health Products and Food Branch, of the Department of Health; (Directeur)
inner label
inner label means the label on or affixed to an immediate container of a food or drug; (étiquette intérieure)
Lot number
Lot number means any combination of letters, figures, or both, by which any food or drug can be traced in manufacture and identified in distribution; (numéro de lot)
manufacturer
manufacturer[Repealed, SOR/97-12, s. 1]
manufacturer
manufacturer or distributor means a person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug; (fabricantordistributeur)
official method
official method means a method of analysis or examination designated as such by the Director for use in the administration of the Act and these Regulations; (méthode officielle)
outer label
outer label means the label on or affixed to the outside of a package of a food or drug; (étiquette extérieure)
principal display panel
principal display panel has the same meaning as in the Consumer Packaging and Labelling Regulations; (espace principal)
security package
security package means a package having a security feature that provides reasonable assurance to consumers that the package has not been opened prior to purchase. (emballage de sécurité)
A.01.011 The Director shall, upon request, furnish copies of official methods.
A.01.012 The Director shall, upon request, indicate that a method is acceptable or otherwise upon its submission to him for a ruling.
A.01.013 Where a food, drug, vitamin or cosmetic has more than one name, whether proper or common, a reference in these Regulations to the food, drug, vitamin or cosmetic by any of its names is deemed to be a reference to the food, drug or vitamin by all of its names.
A.01.014 When a lot number is required by these Regulations to appear on any article, container, package or label it shall be preceded by one of the following designations:
(a) “Lot number”;
(b) “Lot No.”;
(c) “Lot”; or
(d) “(L)”.
A.01.015 (1) Subject to subsection (2), any statement, information or declaration that is required by these Regulations to appear on the label of any drug shall be in either the French or the English language in addition to any other language.
(2) The adequate directions for use required to be shown on the inner and outer labels of a drug pursuant to subparagraph C.01.004(1)(c)(iii) shall be in both the French and English languages if the drug is available for sale without prescription in an open self-selection area.
A.01.016 All information required by these Regulations to appear on a label of a food or drug shall be
(a) clearly and prominently displayed on the label; and
(b) readily discernible to the purchaser or consumer under the customary conditions of purchase and use.
Analysts; Inspectors
A.01.020 and A.01.021 [Repealed, SOR/81-935, s. 1]
A.01.022 An inspector shall perform the functions and duties and carry out the responsibilities in respect of foods and drugs prescribed by the Act, and these Regulations.
A.01.023 The authority of an inspector extends to and includes the whole of Canada.
A.01.024 The certificate of designation required pursuant to subsection 22(2) of the Act shall
(a) certify that the person named therein is an inspector for the purpose of the Act; and
(b) be signed by
(i) the Director and the person named in the certificate, in the case of an inspector on the staff of the Department, or
(ii) [Repealed, SOR/2000-184, s. 60]
A.01.025 Where authorized by a regulation made pursuant to the Broadcasting Act, inspectors shall act as representatives of the Canadian Radio-television and Telecommunications Commission for the purpose of enforcing the provisions of regulations made by the Canadian Radio-Television and Telecommunications Commission concerning the advertising of any article to which the Proprietary or Patent Medicine Act or the Food and Drugs Act applies, or concerning recommendations for the prevention, treatment or cure of a disease or ailment.
A.01.026 An inspector may, for the proper administration of the Act or these Regulations, take photographs of
(a) any article that is referred to in subsection 23(2) of the Act;
(b) any place where, on reasonable grounds, he believes any article referred to in paragraph (a) is manufactured, prepared, preserved, packaged or stored; and
(c) anything that, on reasonable grounds, he believes is used or capable of being used for the manufacture, preparation, preservation, packaging or storing of any article referred to in paragraph (a).
Importations
A.01.040 Subject to section A.01.044, no person shall import into Canada for sale a food or drug the sale of which in Canada would constitute a violation of the Act or these Regulations.
A.01.041 An inspector may examine and take samples of any food or drug sought to be imported into Canada.
A.01.042 Where an inspector examines or takes a sample of a food or drug pursuant to section A.01.041, he may submit the food or drug or sample to an analyst for analysis or examination.
A.01.043 Where an inspector, upon examination of a food or drug or sample thereof or on receipt of a report of an analyst of the result of an analysis or examination of the food or drug or sample, is of the opinion that the sale of the food or drug in Canada would constitute a violation of the Act or these Regulations, the inspector shall so notify in writing the collector of customs concerned and the importer.
A.01.044 (1) Where a person seeks to import a food or drug into Canada for sale and the sale would constitute a violation of the Act or these Regulations, that person may, if the sale of the food or drug would be in conformity with the Act and these Regulations after its relabelling or modification, import it into Canada on condition that
(a) the person gives to an inspector notice of the proposed importation; and
(b) the food or drug will be relabelled or modified as may be necessary to enable its sale to be lawful in Canada.
(2) No person shall sell a food or drug that has been imported into Canada under subsection (1) unless the food or drug has been relabelled or modified within three months after the importation or within such longer period as may be specified by
(a) in the case of a drug, the Director; or
(b) in the case of food, the Director or the President of the Canadian Food Inspection Agency.
Exports
A.01.045 A certificate referred to in section 37 of the Act shall be signed and issued by the exporter in the form set out in Appendix III.
Sampling
A.01.050 When taking a sample of an article pursuant to paragraph 23(1)(a) of the Act, an inspector shall inform the owner thereof or the person from whom the sample is being obtained of the inspector’s intention to submit the sample or a part thereof to an analyst for analysis or examination, and
(a) where, in the opinion of the inspector, division of the procured quantity would not interfere with analysis or examination
(i) divide the quantity into three parts,
(ii) identify the three parts as the owner’s portion, the sample, and the duplicate sample and where only one part bears the label, that part shall be identified as the sample,
(iii) seal each part in such a manner that it cannot be opened without breaking the seal, and
(iv) deliver the part identified as the owner’s portion to the owner or the person from whom the sample was obtained and forward the sample and the duplicate sample to an analyst for analysis or examination; or
(b) where, in the opinion of the inspector, division of the procured quantity would interfere with analysis or examination
(i) identify the entire quantity as the sample,
(ii) seal the sample in such a manner that it cannot be opened without breaking the seal, and
(iii) forward the sample to an analyst for analysis or examination.
A.01.051 Where the owner or the person from whom the sample was obtained objects to the procedure followed by an inspector under section A.01.050 at the time the sample was obtained, the inspector shall follow both procedures set out in that section if the owner or the person from whom the sample was obtained supplies him with a sufficient quantity of the article.
Tariff of Fees
A.01.060 The cost of analysing a sample other than for the purpose of the Act, for a department of the Government of Canada for the purpose of legal action is $15.
Labelling of Food and Drugs in Pressurized Containers
A.01.060.1 In sections A.01.061 and A.01.062,
flame projection
flame projection means the ability of the pressurized contents of an aerosol container to ignite and the length of that ignition, when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981; (projection de flamme)
flashback
flashback means that part of the flame projection that extends from its point of ignition back to the aerosol container when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981; (retour de flamme)
principal display panel
principal display panel[Repealed, SOR/2000-353, s. 2]
A.01.061 (1) Subject to section A.01.063, in the case of a food or a drug packaged in a disposable metal container designed to release pressurized contents by use of a manually operated valve that forms an integral part of the container, the principal display panel of the inner and outer labels of the food or drug shall display, in accordance with sections 15 to 18 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following information:
(a) the hazard symbol set out in Column II of item 10 of Schedule II to those Regulations, accompanied by the signal word “CAUTION / ATTENTION”; and
(b) the primary hazard statement “CONTAINER MAY EXPLODE IF HEATED. / CE CONTENANT PEUT EXPLOSER S’IL EST CHAUFFÉ.”.
(2) Subject to section A.01.063, one panel of the inner and outer labels of a food or drug referred to in subsection (1) shall display, in the size required by paragraph 19(1)(b) of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following additional hazard statement:
“Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50°C.
Contenu sous pression. Ne pas mettre dans l’eau chaude ni près des radiateurs, poêles ou autres sources de chaleur. Ne pas percer le contenant, ni le jeter au feu, ni le conserver à des températures dépassant 50 °C.”
(3) The requirements of subsections (1) and (2) do not apply where
(a) in relation to a drug or cosmetic, in the opinion of the Director, or
(b) in relation to a food, in the opinion of the Minister of Consumer and Corporate Affairs,
the design of the container, the materials used in its construction or the incorporation of a safety device eliminate the potential hazard therein.
A.01.062 (1) Subject to section A.01.063, if a food or drug is packaged in a container described in subsection A.01.061(1) and has a flame projection of a length set out in column I of any of items 1 to 3 of the table to this subsection or a flashback as set out in column I of item 4 of that table, as determined by official method DO-30, Determination of Flame Projection, dated October 15, 1981, the principal display panel of the inner and outer labels of the food or drug shall display, in accordance with sections 15 to 18 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following information:
(a) the hazard symbol set out in Column II of the same item;
(b) in both official languages, the signal word set out in Column III of the same item; and
(c) in both official languages, the primary hazard statement set out in Column IV of the same item.
TABLE IS NOT DISPLAYED, SEE SOR/81-616, S. 2; SOR/92-15, S. 3
(2) In addition to the requirements of subsection (1), one panel of the inner label and outer labels of a food or drug referred to in that subsection shall display, in the size required by paragraph 19(1)(b) of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001, the following additional hazard statement:
“Do not use in presence of open flame or spark.
Ne pas utiliser en présence d’une flamme nue ou d’étincelles.”
A.01.063 (1) Where the labelled net contents of a container of a food or drug described in subsection A.01.061(1) or A.01.062(1) does not exceed 60 millilitres or 60 grams, the inner label may show only the information described in paragraph A.01.061(1)(a) or paragraphs A.01.062(1)(a) and (b), as the case may be.
(2) Where the labelled net contents of a container of a food or drug described in subsection A.01.061(1) or A.01.062(1) exceeds 60 millilitres or 60 grams but does not exceed 120 millilitres or 120 grams, the inner label may show only the information described in subsection A.01.061(1) or subsection A.01.062(1), as the case may be.
(3) Where the labelled net quantity, in a container, of a food or drug referred to in subsection A.01.061(1) or A.01.062(1) is less than 30 mL or 30 g, the hazard symbol shall be of such size as to be capable of being circumscribed by a circle with a diameter of at least 6 mm.
(4) Where a container of a food or drug, described in subsection (1) or (2) is sold in a package, the outer label may show only the information described in subsection A.01.061(2) and, where applicable, subsection A.01.062(2).
A.01.064 [Repealed, SOR/93-243, s. 2]
Security Packaging
A.01.065 (1) In this section, drug for human use means a drug that is intended for human use, whether the drug is
(a) a mouthwash;
(b) to be inhaled, ingested or inserted into the body; or
(c) for ophthalmic use.
(2) Subject to subsection (3), no person shall sell or import a drug for human use that is packaged and available to the general public in a self-service display, unless the drug is contained in a security package.
(3) Subsection (2) does not apply to lozenges.
(4) Subject to subsection (5), a statement or illustration that draws attention to the security feature of the security package referred to in subsection (2) shall be carried
(a) on the inner label of the package; and
(b) if the security feature is a part of the outer package, on the outer label.
(5) Subsection (4) does not apply if the security feature of a security package is self-evident and is an integral part of the immediate product container.
PART B
Foods
Division 1
General
B.01.001 In this Part,
agricultural chemical
agricultural chemical means any substance that
(a) is used or represented for use in or upon a food during production, storage or transport, or
(b) has been registered under the Pest Control Products Act
and the use of which results or may reasonably be expected to result in a residue of such substance or a derivative thereof in or upon foods, and includes any pesticide, plant growth regulator, fertilizer, adjuvant, carrier or ingredient used with such a substance, but does not include any
(c) food additives, other than those listed in the tables to Division 15,
(d) nutritive material that is used, recognized or commonly sold as an article or ingredient of food,
(e) vitamin, mineral nutrient or amino acid,
(f) spice, seasoning, flavouring preparation, essential oil, oleoresin or natural extractive,
(g) food packaging material or component thereof, or
(h) drug recommended for administration to animals that may be consumed as food; (produit chimique agricole)
available display surface
available display surface, in respect of a prepackaged product, means
(a) the bottom of an ornamental container or the total surface area of both sides of a tag attached to the ornamental container, whichever is greater,
(b) the total surface area of both sides of a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, and
(c) the total surface area of any other package, excluding the bottom if the contents of the package leak out or are damaged when the package is turned over,
but does not include
(d) any area of a package on which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase,
(e) any part of a package that is intended to be destroyed when it is opened, other than a package of a food that is intended to be consumed by one person at a single eating occasion, or
(f) the area occupied by the universal product code; (surface exposée disponible)
close proximity
close proximity means, with reference to the common name, immediately adjacent to the common name without any intervening printed, written or graphic matter; (à proximité)
common name
common name means, with reference to a food,
(a) the name of the food printed in boldface type in these Regulations,
(b) the name prescribed by any other regulation, or
(c) if the name of the food is not so printed or prescribed, the name by which the food is generally known; (nom usuel)
component
component means an individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an ingredient; (constituant)
daily value
daily value means
(a) in respect of a vitamin or mineral nutrient referred to in the definition recommended daily intake, the recommended daily intake for that vitamin or mineral nutrient, and
(b) in respect of a nutrient referred to in the definition reference standard, the reference standard for that nutrient; (valeur quotidienne)
durable life
durable life means the period, commencing on the day on which a prepackaged product is packaged for retail sale, during which the product, when it is stored under conditions appropriate to that product, will retain, without any appreciable deterioration, its normal wholesomeness, palatability, nutritional value and any other qualities claimed for it by the manufacturer; (durée de conservation)
durable life date
durable life date means the date on which the durable life of a prepackaged product ends; (date limite de conservation)
energy value
energy value means, in respect of a food, the amount of energy made available to a person’s body when the chemical constituents of the food, including protein, fat, carbohydrate and alcohol, are metabolized following ingestion of the food by the person; (valeur énergétique)
extended meat product
extended meat product means a meat product to which a meat product extender has been added; (produit de viande avec allongeur)
extended poultry product
extended poultry product means a poultry product to which a poultry product extender has been added; (produit de volaille avec allongeur)
fish product
fish product means fish or prepared fish; (produit de poisson)
flavouring preparation
flavouring preparation includes any food for which a standard is provided in Division 10; (préparation aromatisante)
food additive
food additive means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include
(a) any nutritive material that is used, recognized or commonly sold as an article or ingredient of food;
(b) vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16,
(c) spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives;
(d) agricultural chemicals, other than those listed in the tables to Division 16,
(e) food packaging materials and components thereof; and
(f) drugs recommended for administration to animals that may be consumed as food; (additif alimentaire)
food colour
food colour means those colours permitted for use in or upon food by Division 6; (colorant alimentaire)
gelling agent
gelling agent means gelatin, agar and carrageenan; (agent gélatinisant)
ingredient
ingredient means an individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an integral unit of food that is sold as a prepackaged product; (ingrédient)
meal replacement
meal replacement means a formulated food that, by itself, can replace one or more daily meals; (substitut de repas)
meat product
meat product means meat, meat by-product, prepared meat or prepared meat by-product; (produit de viande)
meat product extender
meat product extender means a food that is a source of protein and that is represented as being for the purpose of extending meat products; (allongeur de produit de viande)
monounsaturated fatty acids
monounsaturated fatty acids, monounsaturated fat, monounsaturates or monounsaturated means cis-monounsaturated fatty acids; (acides gras monoinsaturés, graisses monoinsaturées, gras monoinsaturés, lipides monoinsaturésoumonoinsaturés)
nutritional supplement
nutritional supplement means a food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients; (supplément nutritif)
nutrition facts table
nutrition facts table means the nutrition facts table that is required by subsection B.01.401(1) to be carried on the label of a prepackaged product; (tableau de la valeur nutritive)
omega-3 polyunsaturated fatty acids
omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fat, omega-3 polyunsaturates, omega-3 polyunsaturated or omega-3 means
(a) 9-cis, 12-cis, 15-cis octadecatrienoic acid or α-linolenic acid,
(b) 8-cis, 11-cis, 14-cis, 17-cis eicosatetraenoic acid,
(c) 5-cis, 8-cis, 11-cis, 14-cis, 17-cis eicosapentaenoic acid or EPA,
(d) 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosapentaenoic acid, or
(e) 4-cis, 7-cis, 10-cis, 13-cis, 16-cis, 19-cis docosahexaenoic acid or DHA; (acides gras polyinsaturés oméga-3, graisses polyinsaturées oméga-3, gras polyinsaturés oméga-3, lipides polyinsaturés oméga-3, polyinsaturés oméga-3ouoméga-3)
omega-6 polyunsaturated fatty acids
omega-6 polyunsaturated fatty acids, omega-6 polyunsaturated fat, omega-6 polyunsaturates, omega-6 polyunsaturated or omega-6 means
(a) 9-cis, 12-cis octadecadienoic acid or linoleic acid,
(b) 6-cis, 9-cis, 12-cis octadecatrienoic acid,
(c) 8-cis, 11-cis, 14-cis eicosatrienoic acid or di-homo-γ-linolenic acid,
(d) 5-cis, 8-cis, 11-cis, 14-cis eicosatetraenoic acid or arachidonic acid,
(e) 7-cis, 10-cis, 13-cis, 16-cis docosatetraenoic acid, or
(f) 4-cis, 7-cis, 10-cis, 13-cis, 16-cis docosapentaenoic acid; (acides gras polyinsaturés oméga-6, graisses polyinsaturées oméga-6, gras polyinsaturés oméga-6, lipides polyinsaturés oméga-6, polyinsaturés oméga-6ouoméga-6)
ornamental container
ornamental container means a container that, except on the bottom, does not have any promotional or advertising material thereon, other than a trade mark or common name and that, because of any design appearing on its surface or because of its shape or texture, appears to be a decorative ornament and is sold as a decorative ornament in addition to being sold as the container of a product; (emballage décoratif)
overage
overage means the amount of a vitamin or mineral nutrient that is, within the limits of good manufacturing practice, added to a food in excess of the amount declared on the label, in order to ensure that the amount of the vitamin or mineral nutrient declared on the label is maintained throughout the durable life of the food; (surtitrage)
parts per million
parts per million means parts per million by weight unless otherwise stated; (parties par million)
per cent
per cent or % means per cent by weight, unless otherwise stated; (pour cent ou %)
polyunsaturated fatty acids
polyunsaturated fatty acids, polyunsaturated fat, polyunsaturates or polyunsaturated means cis-methylene interrupted polyunsaturated fatty acids; (acides gras polyinsaturés, graisses polyinsaturées, gras polyinsaturés, lipides polyinsaturésoupolyinsaturés)
poultry product
poultry product means poultry meat, prepared poultry meat, poultry meat by-product or prepared poultry meat by-product; (produit de volaille)
poultry product extender
poultry product extender means a food that is a source of protein and that is represented as being for the purpose of extending poultry products; (allongeur de produit de volaille)
prepackaged meal
prepackaged meal means a prepackaged selection of foods for one individual that requires no preparation other than heating and that contains at least one serving, as described in Canada’s Food Guide to Healthy Eating, published in 1992 by the Department of Supply and Services by authority of the Minister of National Health and Welfare, of
(a) meat, fish, poultry, legumes, nuts, seeds, eggs or milk or milk products other than butter, cream, sour cream, ice-cream, ice milk and sherbet; and
(b) vegetables, fruit or grain products; (repas préemballé)
prepackaged product
prepackaged product means any food that is contained in a package in the manner in which it is ordinarily sold to or used or purchased by a person; (produit préemballé)
principal display panel
principal display panel means, despite the meaning assigned to that term in section A.01.010,
(a) in the case of a label applied to a prepackaged product that is subject to the Consumer Packaging and Labelling Act the principal display panel as defined in the Consumer Packaging and Labelling Regulations,
(b) in the case of a label applied to a prepackaged product that is not subject to the Consumer Packaging and Labelling Act, that part of the label applied to all or part of the side or surface of the container that is displayed or visible under normal or customary conditions of sale or use, and where the container does not have such a side or surface, that part of the label applied to any part of the container, except the bottom, if any, and
(c) in the case of a label applied to a food that is not a prepackaged product, that part of the label applied to all or part of the side or surface of the food that is displayed or visible under normal or customary conditions of sale or use; (espace principal)
reasonable daily intake
reasonable daily intake, in respect of a food set out in Column I of an item of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne raisonnable)
recommended daily intake
recommended daily intake, in respect of a vitamin or mineral nutrient set out in column I of Table I to Division 1 of Part D or in column I of Table I to Division 2 of Part D, means
(a) in the case of a prepackaged product intended solely for children under two years of age, the quantity set out in column III, and
(b) in any other case, the quantity set out in column II; (apport quotidien recommandé)
reference amount
reference amount, in respect of a food set out in column 1 of Schedule M, means the amount of that food set out in column 2; (quantité de référence)
reference standard
reference standard, in respect of a nutrient set out in column 1 of the table to section B.01.001.1, means the amount set out in column 2; (norme de référence)
saturated fatty acids
saturated fatty acids, saturated fat, saturates or saturated means all fatty acids that contain no double bonds; (acides gras saturés, graisses saturées, gras saturés, lipides saturésousaturés)
simulated meat product
simulated meat product means any food that does not contain any meat product, poultry product or fish product but that has the appearance of a meat product; (simili-produit de viande)
simulated poultry product
simulated poultry product means any food that does not contain any poultry product, meat product or fish product but that has the appearance of a poultry product; (simili-produit de volaille)
sugars
sugars means all monosaccharides and disaccharides; (sucres)
sweetener
sweetener means any food additive listed as a sweetener in Table IX to section B.16.100; (édulcorant)
sweetening agent
sweetening agent includes any food for which a standard is provided in Division 18, but does not include those food additives listed in the tables to Division 16; (agent édulcorant)
trans fatty acids
trans fatty acids, trans fat or trans means unsaturated fatty acids that contain one or more isolated or non-conjugated double bonds in a trans-configuration; (acides gras trans, graisses trans, gras trans, lipides transoutrans)
unstandardized food
unstandardized food means any food for which a standard is not prescribed in this Part; (aliment non normalisé)
weighted recommended nutrient intake
weighted recommended nutrient intake, in respect of a vitamin or mineral nutrient set out in column I of Table II to Division 1 of Part D or in column I of Table II to Division 2 of Part D, means the amount set out in column III; (apport nutritionnel recommandé pondéré)
yolk-replaced egg
yolk-replaced egg means a food that
(a) does not contain egg yolk but contains fluid, dried or frozen egg albumen or mixtures thereof,
(b) is intended as a substitute for whole egg, and
(c) meets the requirements of section B.22.032. (oeuf à jaune substitué)
B.01.001.1 (1) In this section, fat means all fatty acids expressed as triglycerides.
(2) The reference standard for a nutrient set out in column 1 of the table to this section is the amount set out in column 2.
TABLE
Reference Standards
Column 1Column 2ItemNutrientAmount1Fat65 g2The sum of saturated fatty acids and trans fatty acids20 g3Cholesterol300 mg4Carbohydrate300 g5Fibre25 g6Sodium2400 mg7Potassium3500 mgB.01.002 Each provision in this Part in which the symbol [S] appears between the provision number and the name of the food described in that provision prescribes the standard of composition, strength, potency, purity, quality or other property of that food and a provision in which the symbol does not appear does not prescribe a standard for a food.
B.01.002A (1) For the purposes of this Part, a serving of stated size of a food shall be
(a) based on the food as offered for sale; and
(b) expressed
(i) in grams, if
(A) the net quantity of the food is declared on the label by weight or by count, or
(B) the food is set out in column 1 of item 78, 149 or 150 of Schedule M, and
(ii) in millilitres, if the net quantity of the food is declared on the label by volume, except in the case of a food referred to in clause (i)(B).
(2) A serving of stated size shall be the net quantity of the food in the package if
(a) the quantity of food can reasonably be consumed by one person at a single eating occasion;
(b) the reference amount of the food is less than 100 g or 100 mL and the package contains less than 200% of that reference amount; or
(c) the reference amount of the food is 100 g or 100 mL or more and the package contains 150% or less of that reference amount.
B.01.003 (1) The following foods shall carry a label when offered for sale:
(a) all prepackaged products other than
(i) prepackaged confections, commonly known as one bite confections, that are sold individually, and
(ii) prepackaged products consisting of fresh fruits or fresh vegetables that are packaged in a wrapper or confining band of less than 1/2 inch in width;
(b) meat and meat by-products that are barbecued, roasted or broiled on the retail premises;
(c) poultry, poultry meat or poultry meat by-products that are barbecued, roasted or broiled on the retail premises;
(d) horse-meat or horse-meat by-product;
(e) any substance or mixture of substances for use as a food additive or food additive preparation; and
(f) flour and whole wheat flour that has been treated with gamma radiation from Cobalt 60 Source.
(2) [Repealed, SOR/79-23, s. 2]
B.01.004 (1) All or part of the label referred to in section B.01.003 shall be applied
(a) in the case of a prepackaged product, to the container in which the prepackaged product is sold; and
(b) in the case of a food that is not a prepackaged product, to the food itself.
(2) The label shall be applied in such a manner that the container of the prepackaged product or the food, as the case may be, will bear the label at the time it is sold.
B.01.005 (1) Subject to subsections (2) to (5), the information required to be shown on a label shall not be shown on that part of the label, if any, that is applied to the bottom of a food or container.
(2) The information required to be shown on a label may be shown on that part of the label, if any, that is applied to the bottom of a food or to the bottom of a container if such information is also shown in those parts of the label that are not applied to the bottom of the food or container.
(3) Notwithstanding subsection (2), where the container of a prepackaged product is an ornamental container and the label is applied to the bottom of the container, the information required to be shown may be shown on the label that is applied to the bottom of the container.
(4) Notwithstanding subsection (2), the information required by subparagraph B.01.007(1.1)(b)(i) or paragraph B.24.103(g) or B.25.057(1)(f) or (2)(f) may be shown on that part of the label that is applied to the bottom of the package if a clear indication of the location of the required information appears elsewhere on the label.
(5) Notwithstanding subsection (2), the nutrition facts table may be shown on that part of the label that is applied to the bottom of the food or container if the available display surface includes the bottom.
B.01.006 (1) The common name of the food shall be shown on the principal display panel.
(2) Notwithstanding subsection (1), the common name of a fresh fruit or fresh vegetable that is prepackaged in such a manner that the fruit or vegetable is visible and identifiable in the package is not required to be shown on the label.
B.01.007 (1) In this section, packaging date means
(a) the date on which a food is placed for the first time in a package in which it will be offered for sale to a consumer; or
(b) the date on which a prepackaged product is weighed by a retailer in a package in which it will be offered for sale for the first time to a consumer.
(1.1) The following information shall be shown on any part of the label:
(a) the identity and principal place of business of the person by or for whom the food was manufactured or produced;
(b) where a prepackaged product having a durable life of 90 days or less is packaged at a place other than the retail premises from which it is to be sold,
(i) the durable life date, and
(ii) instructions for the proper storage of the prepackaged product if it requires storage conditions that differ from normal room temperature; and
(c) where a prepackaged product having a durable life of 90 days or less is packaged on the retail premises from which it is to be sold,
(i) the packaging date, and
(ii) the durable life of the food, except when the durable life appears on a poster next to the food.
(1.2) The packaging date referred to in paragraph (1.1)(c) shall be shown in the form and manner prescribed for the durable life date by subsections (4) and (5) and the terms “best before” and “meilleur avant” on the label shall be replaced by the terms “packaged on” and “empaqueté le”.
(2) Paragraph (1.1)(a) does not apply to fresh fruits or fresh vegetables that are prepackaged on retail premises in such a manner that the fruits or vegetables are visible and identifiable in the package.
(3) Paragraphs (1.1)(b) and (c) do not apply to
(a) prepackaged products consisting of fresh fruits or fresh vegetables;
(b) prepackaged individual portions of food that are served by a restaurant or other commercial enterprise with meals or snacks;
(c) prepackaged individual servings of food that are prepared by a commissary and sold by automatic vending machines or mobile canteens; or
(d) prepackaged donuts.
(4) The durable life date shall be shown in the following manner:
(a) the words “best before” and “meilleur avant” shall be shown grouped together with the durable life date unless a clear explanation of the significance of the durable life date appears elsewhere on the label;
(b) where, for the sake of clarity, it is necessary to show the year in which the durable life date occurs, the year shall be shown first and shall be expressed by at least the last two numbers of the year;
(c) the month shall be shown in words after the year, if the year is shown, and may be abbreviated as prescribed by subsection (5); and
(d) the day of the month shall be shown after the month and shall be expressed in numbers.
(5) The month of the durable life date, when abbreviated, shall be abbreviated as follows and only one such abbreviation shall be used for the English language and the French language:
JA
for JANUARY
FE
for FEBRUARY
MR
for MARCH
AL
for APRIL
MA
for MAY
JN
for JUNE
JL
for JULY
AU
for AUGUST
SE
for SEPTEMBER
OC
for OCTOBER
NO
for NOVEMBER
DE
for DECEMBER
(6) Except as otherwise provided in these Regulations, no person shall use a durable life date marking system on the label of a prepackaged product or in advertising a prepackaged product other than the marking system set out in this section.
(7) Paragraph (1.1)(b) does not apply to prepackaged fresh yeast, if
(a) the date on which it is estimated that the product has lost its effectiveness is shown on the label in the form and manner prescribed for the durable life date by subsections (4) and (5); and
(b) the terms “best before” and “meilleur avant” are replaced by the terms “use by” and “employez avant”.
B.01.008 (1) The following information shall be shown grouped together on any part of the label:
(a) any information required by these Regulations, other than the information required to appear on the principal display panel or the nutrition facts table and the information required by sections B.01.007, B.01.301, B.01.305, B.01.311, B.01.503, B.01.513 and B.01.601; and
(b) where a prepackaged product consists of more than one ingredient, a list of all ingredients, including, subject to section B.01.009, components, if any.
(2) Paragraph (1)(b) does not apply to
(a) prepackaged products packaged from bulk on retail premises, except prepackaged products that are a mixture of nuts;
(b) prepackaged individual portions of food that are served by a restaurant or other commercial enterprise with meals or snacks;
(c) prepackaged individual servings of food that are prepared by a commissary and sold by automatic vending machines or mobile canteens;
(d) prepackaged meat and meat by-products that are barbecued, roasted or broiled on the retail premises;
(e) prepackaged poultry, poultry meat or poultry meat by-products that are barbecued, roasted or broiled on the retail premises;
(f) Bourbon whisky and prepackaged products subject to compositional standards in Division 2; or
(g) prepackaged products subject to compositional standards in Division 19.
(3) Ingredients shall be shown in descending order of their proportion of the prepackaged product or as a percentage of the prepackaged product and the order or percentage shall be the order or percentage of the ingredients before they are combined to form the prepackaged product.
(4) Notwithstanding subsection (3), the following ingredients may be shown at the end of the list of ingredients in any order:
(a) spices, seasonings and herbs, except salt;
(b) natural and artificial flavours;
(c) flavour enhancers;
(d) food additives, except ingredients of food additive preparations or mixtures of substances for use as a food additive;
(e) vitamins;
(f) salts or derivatives of vitamins;
(g) mineral nutrients; and
(h) salts of mineral nutrients.
(5) Components shall be shown
(a) immediately after the ingredient of which they are components in such a manner as to indicate that they are components of that ingredient; and
(b) in descending order of their proportion of the ingredient.
(6) Notwithstanding paragraph (1)(b) and subsection (5), but subject to section B.01.009, where one or more components of an ingredient are required by these Regulations to be shown in the list of ingredients on the label of a prepackaged product, the ingredient that contains the components is not required to be shown in the list if all components of that ingredient are listed by their common names with the other ingredients of the product
(a) in descending order of their proportion of the product, or
(b) as a percentage of the product,
the order or percentage, as the case may be, being based
(c) in the case of components, on the total amount of each of the components before they are combined to form ingredients in the product; and
(d) in the case of ingredients, on the amount of each of the ingredients before they are combined to form the product.
(7) Notwithstanding paragraph (1)(b), wax coating compounds and their components are not required to be shown on the label of a prepackaged fresh fruit or fresh vegetable as an ingredient or component thereof.
(8) Notwithstanding paragraph (1)(b), sausage casings are not required to be shown on the label of prepackaged sausages as an ingredient or component thereof.
(9) Notwithstanding paragraph (1)(b), hydrogen, when used for hydrogenation purposes, is not required to be shown on the label of any prepackaged product as an ingredient or component thereof.
(10) Notwithstanding paragraph (1)(b), components of ingredients of a sandwich made with bread are not required to be shown in the list of ingredients on the label of the sandwich.
B.01.009 (1) Components of ingredients or of classes of ingredients set out in the following table are not required to be shown on a label:
TABLE
ItemIngredient1butter2margarine3shortening4lard5leaf lard6monoglycerides7diglycerides8rice9starches or modified starches10breads subject to compositional standards in sections B.13.021 to B.13.02911flour12soy flour13graham flour14whole wheat flour15baking powder16milks subject to compositional standards in sections B.08.003 to B.08.02717chewing gumbase18sweetening agents subject to compositional standards in sections B.18.001 to B.18.01819cocoa, low-fat cocoa20salt21vinegars subject to compositional standards in sections B.19.003 to B.19.00722Bourbon whisky and alcoholic beverages subject to compositional standards in sections B.02.001 to B.02.13423cheese for which a standard is prescribed in Division 8, if the total amount of cheese in a prepackaged product is less than 10 per cent of that packaged product24jams, marmalades and jellies subject to compositional standards in sections B.11.201 to B.11.241 when the total amount of those ingredients is less than 5 per cent of a prepackaged product25olives, pickles, relish and horse-radish when the total amount of those ingredients is less than 10 per cent of a prepackaged product26one or more vegetable or animal fats or oils for which a standard is prescribed in Division 9, and hydrogenated, modified or interesterified vegetable or animal fats or oils, if the total of those fats and oils as are contained in a prepackaged product is less than 15 per cent of that prepackaged product27prepared or preserved meat, fish, poultry meat, meat by-product or poultry by-product when the total amount of those ingredients is less than 10 per cent of a prepackaged product that consists of an unstandardized food28alimentary paste that does not contain egg in any form or any flour other than wheat flour29bacterial culture30hydrolysed plant protein31carbonated water32whey, whey powder, concentrated whey, whey butter and whey butter oil33mould culture34chlorinated water and fluorinated water35gelatin36toasted wheat crumbs used in or as a binder, filler or breading in or on a food product(2) Subject to subsection (3), where a preparation or mixture set out in the table to this subsection is added to a food, the ingredients and components of the preparation or mixture are not required to be shown on the label of that food.
TABLE
ItemPreparation/Mixture1food colour preparations2flavouring preparations3artificial flavouring preparations4spice mixtures5seasoning or herb mixtures6vitamin preparations7mineral preparations8food additive preparations9rennet preparations10food flavour-enhancer preparations11compressed, dry, active or instant yeast preparations(3) Where a preparation or mixture set out in the table to subsection (2) is added to a food, and the preparation or mixture contains one or more of the following ingredients or components, those ingredients or components shall be shown by their common names in the list of the ingredients of the food to which they are added as if they were ingredients of that food:
(a) salt;
(b) glutamic acid or its salts;
(c) hydrolysed plant protein;
(d) aspartame;
(e) potassium chloride; and
(f) any ingredient or component that performs a function in, or has any effect on, that food.
(4) Notwithstanding subsections (1) and (2), where any of the following components is contained in an ingredient set out in the tables to those subsections, that component shall be shown in the list of ingredients:
(a) peanut oil;
(b) hydrogenated or partially hydrogenated peanut oil; and
(c) modified peanut oil.
(5) Notwithstanding subsection B.01.008(10) and item 23 of the table to subsection (1), if lysozyme from egg white is added to a food described in section B.08.033 or B.08.034, the label of the food shall show “lysozyme from egg white” in the list of ingredients in the same manner that is required in subsection B.01.008(4) or (5), as applicable.
B.01.010 (1) In this section, common name includes a name set out in Column II of the tables to subsection (3).
(2) An ingredient or component shall be shown in the list of ingredients by its common name.
(3) For the purposes of subsection (2),
(a) the ingredient or component set out in Column I of an item of the following table shall be shown in the list of ingredients by the common name set out in Column II of that item:
TABLE
Column IColumn IIItemIngredient or ComponentCommon Name1any oil, fat or tallow described in section B.09.002 of Division 9, except lard, leaf or suetthe name of the meat from which the oil, fat or tallow is obtained plus oil, fat or tallow2shortening or margarine containing fats or oils, except shortening or margarine containing coconut oil, palm oil, palm kernel oil, peanut oil or cocoa buttershortening or margarine modified by vegetable oil or marine oil or by the common name of the vegetable, animal or marine oil or fat used3shortening or margarine containing coconut oil, palm oil, palm kernel oil, peanut oil or cocoa buttershortening or margarine modified by the common name of the vegetable oil or fat used4meatthe name of the meat5poultry meatthe name of the poultry6fishthe name of the fish7plant protein productthe name of the plant plus protein product8hydrolyzed plant protein produced by the enzymatic processhydrolyzed plus the name of the plant plus protein9any protein isolatethe name of the source of the protein plus protein or the common name of the protein isolate10any meat by-product described in section B.14.003, other than gelatinthe name of the meat plus by-product or the name of the meat plus the name of the meat by-product11any poultry meat by-product described in section B.22.003the name of the poultry plus by-product or the name of the poultry plus the name of the poultry meat by-product12any oil or fat referred to in section B.09.002 that has been hydrogenated or partially hydrogenated, including tallow, but not including lard“hydrogenated” plus the name of the meat from which the oil, fat or tallow is obtained, plus oil, fat or tallow13any oil or fat referred to in section B.09.002 of Division 9, including tallow, that has been modified by the complete or partial removal of a fatty acidmodified plus the name of the meat from which the oil, fat or tallow is obtained, plus oil, fat or tallow14one or more vegetable fats or oils, except coconut oil, palm oil, palm kernel oil, peanut oil or cocoa butter, that have been hydrogenated or partially hydrogenatedhydrogenated vegetable oil or hydrogenated vegetable fat or hydrogenated plus the specific name of the oil or fat15coconut oil, palm oil, palm kernel oil, peanut oil or cocoa butter that has been hydrogenated or partially hydrogenatedhydrogenated plus the specific name of the oil or fat16one or more marine fats or oils that have been hydrogenated or partially hydrogenatedhydrogenated marine oil or hydrogenated marine fat or hydrogenated plus the specific name of the oil or fat17one or more vegetable fats or oils, except coconut oil, palm oil, palm kernel oil, peanut oil or cocoa butter, that have been modified by the complete or partial removal of a fatty acidmodified vegetable oil or modified vegetable fat or modified plus the specific name of the oil or fat18coconut oil, palm oil, palm kernel oil, peanut oil or cocoa butter that has been modified by the complete or partial removal of a fatty acidmodified plus the specific name of the oil or fat19one or more marine fats or oils that have been modified by the complete or partial removal of a fatty acidmodified marine oil or modified plus the specific name of the oil or fat(b) except when one of the ingredients or components set out in column I of the table to this paragraph is shown separately in the list of ingredients by its common name, all of the ingredients or components present in a food set out in column I of an item of that table may be shown collectively in the list of ingredients by the common name set out in column II of that item:
TABLE
Column IColumn IIItemIngredient or ComponentCommon Name1one or more vegetable fats or oils, except coconut oil, palm oil, palm kernel oil, peanut oil or cocoa buttervegetable oil or vegetable fat2one or more marine fats or oilsmarine oil3one or more of the colours listed in Table III of Division 16, except annatto where used in accordance with paragraph B.14.031(i) or subparagraph B.14.032(d)(xvi)colour4one or more substances prepared for their flavouring properties and produced from animal or vegetable raw materials or from food constituents derived solely from animal or vegetable raw materialsflavour5one or more substances prepared for their flavouring properties and derived in whole or in part from components obtained by chemical synthesisartificial flavour, imitation flavour or simulated flavour6one or more spices, seasonings or herbs except saltspices, seasonings or herbs7any of the following in liquid, concentrated, dry, frozen or reconstituted form, namely, butter, buttermilk, butter oil, milk fat, cream, milk, partly skimmed milk, skim milk and any other component of milk the chemical composition of which has not been altered and that exists in the food in the same chemical state in which it is found in milkmilk ingredients7.1any of the following in liquid, concentrated, dry, frozen or reconstituted form, namely, calcium-reduced skim milk (obtained by the ion-exchange process), casein, caseinates, cultured milk products, milk serum proteins, ultrafiltered milk, whey, whey butter, whey cream and any other component of milk the chemical state of which has been altered from that in which it is found in milkmodified milk ingredients7.2one or more ingredients or components set out in item 7 combined with any one or more ingredients or components set out in item 7.1modified milk ingredients8any combination of disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphatesodium phosphate or sodium phosphates9one or more species of bacteriabacterial culture10one or more species of mouldmold culture or mould culture11preparation containing renninrennet12milk coagulating enzymes fromAspergillus oryzae
RET-1 (pBoel777),Endothia parasitica, Rhizomucor miehei
(Cooney and Emerson) (previous name:Mucor miehei
(Cooney and Emerson))orMucor pusillus Lindt
microbial enzyme13one or more substances the function of which is to impart flavour and that are obtained solely from the plant or animal source after which the flavour is namedthe name of the plant or animal source plus the word “flavour”14toasted wheat crumbs made by cooking a dough prepared with flour and water, which may be unleavened or chemically or yeast leavened, and which otherwise complies with the standard prescribed by section B.13.021 or B.13.022toasted wheat crumbs15that portion of chewing gum, other than the coating, that does not impart sweetness, flavour or colourgum base16sugar, liquid sugar, invert sugar or liquid invert sugar, singly or in combinationsugar17glucose syrups and isomerized glucose syrups, singly or in combination, where the fructose fraction does not exceed 60 per cent of the sweetener on a dry basisglucose-fructose18glucose syrups and isomerized glucose syrups, singly or in combination, where the fructose fraction exceeds 60 per cent of the sweetener on a dry basisfructose syrup19sugar or glucose-fructose, singly or in combinationsugar/glucose-fructose20water to which carbon dioxide is addedcarbonated water21one or more of the following food additives, namely, potassium bisulphite, potassium metabisulphite, sodium bisulphite, sodium metabisulphite, sodium sulphite, sodium dithionite, sulphurous acid and sulphur dioxidesulphiting agents or sulphites22demineralized water or water otherwise treated to remove hardness or impurities, or fluoridated or chlorinated waterwater23wine vinegar, spirit vinegar, alcohol vinegar, white vinegar, grain vinegar, malt vinegar, cider vinegar or apple vinegar, singly or in combinationvinegar(4) Notwithstanding subsection (2) and subsection B.01.008(5), where a food contains ingredients of the same class, those ingredients may be shown by a class name if
(a) they consist of more than one component and are not listed in the table to subsection B.01.009(1); and
(b) their components are shown
(i) immediately after the class name of the ingredients of which they are components, in such a manner as to indicate that they are components of the ingredients, and
(ii) in descending order of their collective proportion of those ingredients.
B.01.011 (1) Where it is an acceptable manufacturing practice for a manufacturer to
(a) omit from his prepackaged product any food that is ordinarily an ingredient or component, or
(b) substitute in whole or in part in his prepackaged product any other food for a food that is ordinarily an ingredient or component,
the list of ingredients for the 12-month period commencing from the time the label is applied to the prepackaged product may show as ingredients or components the foods that may be omitted and the foods that may be used as substitutes if
(c) all the foods that may be used as ingredients or components throughout the 12-month period are shown in the list of ingredients;
(d) it is clearly stated as part of the list of ingredients that the food shown as an ingredient or component may not be present or that another food may be substituted for a food shown as an ingredient or component; and
(e) the foods that may be omitted or substituted are grouped with the same class of foods that are used as ingredients or components and the foods within each such group are listed in descending order of the proportion in which they will probably be used during the 12-month period.
(2) Where it is an acceptable manufacturing practice for a manufacturer to vary the proportions of ingredients or components of his prepackaged product, the list of ingredients for the 12-month period commencing from the time the label is applied to the prepackaged product may show the ingredients or components in the same proportions throughout the 12-month period if
(a) it is clearly stated as part of the list of ingredients that the proportions indicated are subject to change; and
(b) the ingredients or components are listed in descending order of the proportion in which they will probably be used during the 12-month period.
B.01.012 (1) In this section,
local government unit
local government unit means a city, metropolitan government area, town, village, municipality or other area of local government but does not include any local government unit situated within a bilingual district established under the Official Languages Act; (collectivité locale)
local food
local food means a food that is manufactured, processed, produced or packaged in a local government unit and sold only in
(a) the local government unit in which it is manufactured, processed or packaged,
(b) one or more local government units that are immediately adjacent to the one in which it is manufactured, processed, produced or packaged, or
(c) the local government unit in which it is manufactured, processed, produced or packaged and in one or more local government units that are immediately adjacent to the one in which it is manufactured, processed, produced or packaged; (produit alimentaire local)
mother tongue
mother tongue means the language first learned in childhood by persons in any area of Canada and still understood by them as ascertained by the decennial census taken immediately preceding the date on which the food referred to in subsection (3) is sold to the consumer; (langue maternelle)
official languages
official languages means the English language and the French language; (langues officielles)
specialty food
specialty food means a food that
(a) has special religious significance and is used in religious ceremonies; or
(b) is an imported food
(i) that is not widely used by the population as a whole in Canada, and
(ii) for which there is no readily available substitute that is manufactured, processed, produced or packaged in Canada and that is generally accepted as being a comparable substitute; (aliment spécial)
test market food
test market food means a food that, prior to the date of the notice of intention respecting that food referred to in subsection (5), was not sold in Canada in that form and that differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form and includes a food referred to in section B.01.054. (produit alimentaire d’essai)
(2) Subject to subsections (9), (10) and (11), all information required by these Regulations to be shown on the label of a food shall be shown in both official languages.
(3) Subject to subsections (4) to (6), subsection (2) does not apply to a local food or test market food if
(a) it is sold in a local government unit in which one of the official languages is the mother tongue of less than 10 per cent of the total number of persons residing in the local government unit; and
(b) the information required by these Regulations to be shown on the label of a food is shown in the official language that is the mother tongue of at least 10 per cent of the total number of persons residing in the local government unit.
(4) Where one of the official languages is the mother tongue of less than 10 per cent of the total number of persons residing in a local government unit and the other official language is the mother tongue of less than 10 per cent of the total number of persons residing in the same local government unit, subsection (3) does not apply.
(5) Subsection (3) does not apply to a test market food unless the person who intends to conduct the test marketing of the food has, six weeks prior to conducting the test marketing, filed with the President of the Canadian Food Inspection Agency a notice of intention in a form acceptable to the President.
(6) A test market food shall, for the purposes of subsection (3), cease to be a test market food upon the expiration of 12 cumulative months after the date on which it was first offered for sale as a test market food but any test market food that was acquired for resale by a person, other than the person who filed the notice of intention referred to in subsection (5), before the expiration of those 12 cumulative months, shall continue to be a test market food for the purposes of subsection (3) until it is sold.
(7) Subsection (2) does not apply to a specialty food if the information required by these Regulations to be shown on the label thereon is shown in one of the official languages.
(8) Where there are one or more surfaces on the label of a food that are of at least the same size and prominence as the principal display panel, the information required by these Regulations to be shown on the principal display panel may be shown in one official language if such information is shown in the other official language on one of those other surfaces.
(9) Subsection (2) does not apply to the identity and principal place of business of the person by or for whom the food was manufactured, processed, produced or packaged for resale if this information is shown in one of the official languages.
(10) Subsection (2) does not apply to the following common names if the common name appears on the principal display panel in the following manner:
Scotch Whisky
Irish Whisky
Highland Whisky
Dry Gin
Bourbon
Tennessee Whisky
Tequila
Mezcal
Rye Whisky
Crème de Menthe
Crème de Cacao
Crème de Cassis
Crème de Banane
Triple Sec
Anisette
Crème de Noyau
Brandy
Sake or Saki
Advocaat or Advokaat
Kirsch
Slivovitz
Ouzo
Cherry Brandy Liqueur
Kummel
Akvavit
Aquavit
Armagnac
Marc
Grappa
Calvados
Poire William
Crème de Bleuets
Curaçao Orange
Liqueur de Fraise
Mandarinette
Prunelle de Bourgogne
Chartreuse
Pastis
Fior d’Alpe
Strega
Campari
Americano
Apricot Brandy Liqueur
Peach Brandy Liqueur
Sloe Gin
Manhattan
Martini
(11) Subsection (2) does not apply to the label of a shipping container destined to a commercial or industrial enterprise or institution, if
(a) the shipping container and its contents are not resold as a one unit prepackaged product to a consumer at the retail level; and
(b) all information required by these Regulations to be shown on a label of a food is shown in one of the official languages.
B.01.013 (1) Unless specifically required by the Act or these Regulations, no reference, direct or indirect, to the Act or to these Regulations shall be made on any label of, or in any advertisement for, a food.
(2) Notwithstanding subsection (1), where a food complies with a standard established by these Regulations and the manufacturer of the food has substantiated, by means of the results of tests carried out before the statement is made or by other evidence that exists before the statement is made, that the food so complies, a statement that the food “complies with the standard for (naming the common name of the food in respect of which the claim is made) in the Food and Drug Regulations” may be made on the label of, or in an advertisement for, the food.
B.01.014 The label of a food, other than a sweetener, that contains aspartame shall carry the following information:
(a) subject to paragraph (b), a statement on the principal display panel to the effect that the food contains aspartame or is sweetened with aspartame, in letters of at least the same size and prominence as the letters used in the numerical portion of the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;
(b) in the case where other sweeteners are used in conjunction with aspartame, a statement on the principal display panel to the effect that the food
(i) contains aspartame and (naming the other sweeteners), or
(ii) is sweetened with aspartame and (naming the other sweeteners),
in letters of at least the same size and prominence as the letters used in the numerical portion of the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;
(c) a statement on any part of the label to the effect that aspartame contains phenylalanine; and
(d) a statement setting out the aspartame content expressed in milligrams per serving of stated size.
B.01.015 (1) The label of a food that is a sweetener that contains aspartame shall carry the following information:
(a) a statement on the principal display panel to the effect that the food contains aspartame or is sweetened with aspartame, in letters of at least the same size and prominence as the letters used in the numerical portion of the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;
(b) a statement on any part of the label to the effect that aspartame contains phenylalanine;
(c) a statement on any part of the label of the sweetness per serving expressed in terms of the amount of sugar required to produce an equivalent degree of sweetness; and
(d) a statement setting out the aspartame content expressed in milligrams per serving of stated size.
(2) The label of a sweetener that contains aspartame may carry the expression “Low Calorie” if the energy value of a serving of the sweetener that is equivalent in sweetness to one teaspoon (5 g) of sugar is no greater than two calories.
B.01.016 The label of a food, other than a table-top sweetener, that contains sucralose shall carry the following information:
(a) subject to paragraph (b), a statement on the principal display panel to the effect that the food contains sucralose or is sweetened with sucralose, in letters of at least the same size and prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;
(b) where sucralose is used in conjunction with another sweetener or a sweetening agent or both, the names thereof shown in a statement on the principal display panel to the effect that the food contains, or is sweetened with, sucralose and the other sweetener or the sweetening agent or both, as the case may be, in letters as described in paragraph (a); and
(c) a statement setting out the sucralose content expressed in milligrams per serving of stated size.
B.01.017 (1) The label of a food that is a table-top sweetener that contains sucralose shall carry the following information:
(a) a statement on the principal display panel to the effect that the food contains sucralose or is sweetened with sucralose, in letters of at least the same size and prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;
(b) a statement on any part of the label setting out the sweetness per serving expressed in terms of the amount of sugar required to produce an equivalent degree of sweetness; and
(c) a statement setting out the sucralose content expressed in milligrams per serving of stated size.
(2) The label of a food that is a table-top sweetener that contains sucralose may carry the words Low Calorie if the energy value of a serving of the sweetener that is equivalent in sweetness to one teaspoon (5 g) of sugar is no greater than two calories.
B.01.018 The label of a food that contains polydextrose shall indicate the amount of polydextrose expressed in grams per serving of stated size.
B.01.019 The label of a food, other than a table-top sweetener, that contains acesulfame-potassium shall carry the following information:
(a) subject to paragraph (b), a statement on the principal display panel to the effect that the food contains acesulfame-potassium or is sweetened with acesulfame-potassium, in letters of at least the same size and prominence as the characters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;
(b) where acesulfame-potassium is used in conjunction with another sweetener or a sweetening agent or both, the names thereof shown in a statement on the principal display panel to the effect that the food contains, or is sweetened with, acesulfame-potassium and the other sweetener or the sweetening agent or both, as the case may be, in letters as described in paragraph (a); and
(c) a statement setting out the acesulfame-potassium content expressed in milligrams per serving of stated size.
B.01.020 (1) The label of a food that is a table-top sweetener that contains acesulfame-potassium shall carry the following information:
(a) a statement, on the principal display panel, to the effect that the food contains acesulfame-potassium or is sweetened with acesulfame-potassium, in letters of at least the same size and prominence as the characters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;
(b) a statement, on any part of the label, setting out the sweetness per serving, expressed in terms of the amount of sugar required to produce an equivalent degree of sweetness; and
(c) a statement setting out the acesulfame-potassium content expressed in milligrams per serving of stated size.
(2) The label of a food that is a table-top sweetener that contains acesulfame-potassium may carry the word Low-Calorie if the energy value of a serving of the sweetener that is equivalent in sweetness to one teaspoon (5 g) of sugar is no greater than two calories.
B.01.021 (1) The label of a food that contains erythritol shall carry a statement indicating the amount of erythritol expressed in grams per serving of stated size unless the label carries a nutrition facts table.
(2) The statement of the amount of erythritol shall be grouped together with the statement of the amount of any other sugar alcohols and the amount of polydextrose.
B.01.033 (1) Except in the case of infant formula or a formulated liquid diet, no person shall sell a food represented in any manner as containing hydrolyzed or partially hydrolyzed collagen, hydrolyzed or partially hydrolyzed gelatin or hydrolyzed or partially hydrolyzed casein unless the label carries the following statement on the principal display panel in the same size type used for the common name:
“CAUTION, DO NOT USE AS SOLE SOURCE OF NUTRITION”.
(2) In this section, formulated liquid diet means a food that meets the requirements of sections B.24.101 to B.24.103.
B.01.034 [Repealed, SOR/88-559, s. 7]
B.01.035 (1) Subject to subsection (8), where an irradiated food referred to in Column I of the table to Division 26 is offered for sale as a prepackaged product, the principal display panel of the label applied to the package shall carry the symbol described in subsection (5).
(2) Where an irradiated food referred to in Column I of the table to Division 26 is not a prepackaged product and is offered for sale, a sign that carries the symbol described in subsection (5) shall be displayed immediately next to the food.
(3) The symbol required pursuant to subsection (1) or (2) shall appear in close proximity on the principal display panel referred to in subsection (1) or on the sign referred to in subsection (2) to one of the following statements or a written statement that has the same meaning:
(a) “treated with radiation”;
(b) “treated by irradiation”; or
(c) “irradiated”.
(4) No person shall sell a food referred to in Column I of the table to Division 26 that has been irradiated in the manner set out in subsection B.26.003(2) unless the requirements of subsections (1) to (3) are met.
(5) For the purposes of subsections (1) to (3), the symbol that indicates the irradiated food shall
(a) have an outer diameter
(i) in the case referred to in subsection (1), equal to or greater than the height of the numerical quantity prescribed by section 14 of the Consumer Packaging and Labelling Regulations for the declaration of net quantity of the package, and
(ii) in the case referred to in subsection (2), not less than 5 cm; and
(b) be in the following form:
(6) Notwithstanding subsection B.01.009(1), any food referred to in Column I of the table to Division 26 that is an ingredient or component of a prepackaged product and that has been irradiated shall, if the food constitutes 10 per cent or more of the prepackaged product, be included in the list of ingredients and preceded by the statement “irradiated”.
(7) The label attached to a shipping container containing any food referred to in Column I of the table to Division 26 that has been subjected to the maximum permitted absorbed dose set out in Column IV of that table shall carry the statement required by subsection (3) and the statement “Do not irradiate again”.
(8) Where a shipping container constitutes the package of the prepackaged product, the label attached to the shipping container shall carry the statement required by subsection (7) but need not carry the symbol required by subsection (5).
(9) Any advertising of an irradiated food referred to in Column I of the table to Division 26 shall identify the food as having been irradiated.
(10) The statements referred to in subsections (3) and (6) to (8) shall be in both official languages in accordance with subsection B.01.012(2).
B.01.037 [Repealed, SOR/88-559, s. 8]
B.01.040 [Repealed, SOR/88-559, s. 9]
B.01.042 Where a standard for a food is prescribed in this Part,
(a) the food shall contain only the ingredients included in the standard for the food;
(b) each ingredient shall be incorporated in the food in a quantity within any limits prescribed for that ingredient; and
(c) if the standard includes an ingredient to be used as a food additive for a specified purpose, that ingredient shall be a food additive set out in one of the tables to section B.16.100 for use as an additive to that food for that purpose.
B.01.043 Subject to section B.25.062, where a standard for a food is not prescribed in this Part,
(a) the food shall not contain any food additives except food additives set out in a table to section B.16.100 for use as additives to that food for the purpose set out in that table; and
(b) each such food additive shall be incorporated in the food in a quantity within any limits prescribed for that food and food additive in that table.
B.01.044 Where the limit prescribed for a food additive in a table to section B.16.100 is stated to be “Good Manufacturing Practice”, the amount of the food additive added to a food in manufacturing and processing shall not exceed the amount required to accomplish the purpose for which that additive is permitted to be added to that food.
B.01.045 A food additive shall,
(a) where specifications are set out in this Part for that additive, meet those specifications;
(b) where no specifications are set out in this Part for that additive but specifications are set out for it in the Food Chemicals Codex, Fourth Edition, 1996, published by the National Academy of Sciences, Washington, D.C., United States, as amended from time to time, meet those specifications;
(c) in the case of lactitol and maltitol, meet the specifications established by the Joint FAO/WHO Expert Committee on Food Additives as set out in the Specifications for identity and purity of certain food additives — FAO Food and Nutrition Paper 38, published in 1988 by the Food and Agriculture Organization of the United Nations, Rome;
(d) in the case of sucrose esters of fatty acids, meet the specifications established by the Joint FAO/WHO Expert Committee on Food Additives as set out in the Specifications for identity and purity of certain food additives — FAO Food and Nutrition 49 published in 1990 by the Food and Agriculture Organization of the United Nations, Rome; and
(e) [Repealed, SOR/97-512, s. 2]
(f) in the case of isomalt, meet the specifications established by the Joint FAO/WHO Expert Committee on Food Additives as set out in the Compendium of food additive specifications, Addendum 4 — FAO Food and Nutrition Paper 52, published in 1996 by the Food and Agriculture Organization of the United Nations, Rome.
(g) [Repealed, SOR/97-512, s. 2]
B.01.046 (1) A food is adulterated if any of the following substances or classes of substances are present therein or have been added thereto:
(a) mineral oil, paraffin wax or petrolatum or any preparation thereof;
(b) coumarin, an extract of tonka beans, the seed of Dipteryx odorata Willd. or Dipteryx oppositifolia Willd.;
(c) non-nutritive sweetening agents;
(d) cottonseed flour that contains more than 450 parts per million of free gossypol;
(e) fatty acids and their salts containing chick-edema factor or other toxic factors;
(f) dihydrosafrole;
(g) isosafrole;
(h) oil of American sassafras from Sassafras albidum (Nutt). Nees;
(i) oil of Brazilian sassafras from Ocotea cymbarum H.B.K.;
(j) oil of camphor sassafrassy from Cinnamomum camphorum Sieb.;
(k) oil of micranthum from Cinnamomum micranthum Hayata;
(l) safrole;
(m) oil, extract or root of calamus from Acorus calamus L.;
(n) nut and nut products that contain more than 15 parts per billion of aflatoxin;
(o) ethylene thiourea;
(p) chlorinated dibenzo-p-dioxins; or
(q) cinnamyl anthranilate.
(2) For the purpose of paragraph (1)(n), the aflatoxin content of a nut or nut product shall be calculated on the basis of the nut meat portion.
B.01.047 Notwithstanding section B.01.046
(a) a food, other than sausage casing, is not adulterated by reason only that it contains 0.3 per cent or less mineral oil, if good manufacturing practice requires the use of mineral oil;
(b) chewing gum is not adulterated by reason only that it contains a paraffin wax base;
(c) fresh fruits and vegetables, except turnips, are not adulterated by reason only that they are coated with not more than 0.3 per cent paraffin wax and petrolatum, if good manufacturing practices require the use of such coating;
(d) turnips and cheese are not adulterated by reason only that they are coated with paraffin wax in accordance with good manufacturing practice;
(e) sausage casing is not adulterated by reason only that it contains five per cent or less mineral oil by weight, if good manufacturing practice requires the use of mineral oil;
(f) fish is not adulterated by reason only that it contains 20 parts per trillion or less of 2,3,7,8-tetrachlorodibenzoparadioxin;
(g) bakery products and confectionery are not adulterated by reason only that they contain 0.15 per cent or less petrolatum, if good manufacturing practice requires the use of petrolatum;
(h) a salt substitute is not adulterated by reason only that it contains 0.6 per cent or less mineral oil, if good manufacturing practice requires the use of mineral oil; and
(i) fruits, vegetables and cereals are not adulterated by reason only that they contain 0.05 parts per million or less of ethylene thiourea.
B.01.047.1 (1) The following definitions apply in this section.
BSE
BSE means Bovine Spongiform Encephalopathy. (ESB)
specified risk material
specified risk material means
(a) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal cord and dorsal root ganglia of cattle aged 30 months or older; and
(b) the distal ileum of cattle of all ages. (matériel à risque spécifié)
(2) No person shall sell or import for sale food that contains specified risk material.
(3) Subsection (2) does not apply in respect of food that originates from a country that is designated as being free from BSE in accordance with section 7 of the Health of Animals Regulations.
(4) Subsection (2) does not apply in respect of food that is packaged for sale or imported for sale before the day on which this subsection comes into force.
B.01.048 (1) No person shall sell
(a) any animal intended for consumption as food if any product containing any drug listed in subsection (2) has been administered to the animal;
(b) any meat, meat by-products, eggs or milk intended for consumption as food and derived from an animal if any product containing any drug listed in subsection (2) has been administered to that animal; or
(c) any meat, meat by-products, eggs or milk that contains any residue of any drug listed in subsection (2).
(2) The drugs referred to in subsection (1) are
(a) chloramphenicol and its salts and derivatives;
(b) a 5-nitrofuran compound;
(c) clenbuterol and its salts and derivatives;
(d) a 5-nitroimidazole compound; and
(e) diethylstilbestrol and other stilbene compounds.
B.01.049 No person shall use, in labelling, packaging, advertising or selling a food that does not meet the requirements of the kashruth applicable to it, the word “kosher” or any letters of the Hebrew alphabet or any other word, expression, depiction, sign, symbol, mark, device or other representation that indicates or that is likely to create an impression that the food is kosher.
B.01.053 No person shall sell a product represented as a ready breakfast or instant breakfast or by any similar designation unless each serving of stated size of the product contains
(a) not less than 4.0 mg. iron;
(b) Vitamin A, thiamine, riboflavin, niacin or niacinamide and Vitamin C;
(c) a good dietary source of protein; and
(d) where consumed as directed, not less than 300 calories.
B.01.054 (1) In order to generate information in support of an amendment to the Regulations, the Director may issue to the manufacturer or distributor of a food, where the food or the packaging, labelling or advertising of the food does not comply with the requirements of these Regulations, a Temporary Marketing Authorization Letter that authorizes the sale of the food described therein or the packaging, labelling or advertising of the food described therein for a specified period of time, within a designated area and in a specified quantity, in the manner specified in the Letter if
(a) the manufacturer or distributor of the food has supplied to the Director the following information:
(i) the purpose for which the temporary marketing authorization of the food is required,
(ii) a description of the food including a sample and proposed label,
(iii) a description of any proposed variation from the requirements of these Regulations,
(iv) adequate data to show that the use of the food will not be detrimental to the health of the purchaser or user,
(v) the proposed quantity of the food to be sold,
(vi) the proposed period of time required for such sale,
(vii) the proposed area designated for such sale, and
(viii) such other data as the Director may require; and
(b) the manufacturer or distributor of the food has agreed to
(i) describe the food on a label or in an advertisement in a manner that is not false, misleading or deceptive,
(ii) use such marks or statements on the label or in any advertisement as the Director may require,
(iii) on request, submit to the Director results of the temporary marketing, and
(iv) on request, withdraw the product from sale where the Director is of the opinion that it is in the public interest to do so.
(2) The Director shall, in any Temporary Marketing Authorization Letter issued pursuant to subsection (1), set out
(a) the common name and description of the food to be sold;
(b) the name and address of the manufacturer or distributor of the food;
(c) the purpose for which the temporary marketing of the food is authorized;
(d) the quantity of the food that is authorized for sale;
(d.1) the type of packaging, labelling or advertising authorized in respect of the food where the Letter is intended to authorize a variation from a requirement of any provision of the Regulations respecting packaging, labelling or advertising;
(e) the period of time during which the food may be sold; and
(f) the designated area within which the food may be sold.
B.01.055 (1) A manufacturer or distributor named in a Temporary Marketing Authorization Letter issued pursuant to subsection B.01.054(1) may, for the purpose set out in the Letter, sell the food in the manner authorized in the Letter and package, label or advertise that food in the manner authorized in the Letter for the period of time, within the designated area and in the quantity set out in the Letter.
(2) No provision of these Regulations made pursuant to paragraph 30(1)(b) of the Act applies in respect of a food or the packaging, labelling or advertising of a food for which a Temporary Marketing Authorization Letter has been issued pursuant to subsection B.01.054(1) to the extent that the food, or the packaging, labelling or advertising of the food, as authorized in the Letter, does not comply with that provision.
B.01.056 (1) Notwithstanding sections B.01.042 and B.01.043, where a food does not comply with the requirements of these Regulations, the manufacturer or distributor of the food, or of a food additive, agricultural chemical, veterinary drug, vitamin, mineral nutrient or amino acid present in the food, may make a written request to the Director
(a) for the exemption of the food from the application, in whole or in part, of the requirements relating to it under these Regulations;
(b) for a Notice of Interim Marketing Authorization concerning the food that confirms the exemption; and
(c) that these Regulations be amended.
(2) For the purposes of this section, a food does not comply with the requirements of these Regulations if
(a) any of the following is present in the food:
(i) a food additive that is
(A) set out in column I of an item of any of the tables to section B.16.100 in an amount that exceeds the maximum level of use set out in column III or IV of that item in respect of that food, or
(B) not included in the standard for that food in these Regulations,
(ii) an agricultural chemical, or any of its derivatives, set out in column I of an item of Table II to Division 15 of Part B, in an amount that exceeds the maximum residue limit set out in column III of that item,
(iii) a veterinary drug set out in column I of an item of Table III to Division 15 of Part B in an amount that exceeds the maximum residue limit set out in column III of that item,
(iv) an ingredient in a form other than the form described in the standard for that food in these Regulations, or
(v) a vitamin, mineral nutrient or amino acid
(A) that is not set out in the Table to section D.03.002, or
(B) the level of use of which is at variance with the level permitted under these Regulations;
(b) the food
(i) is not set out in column IV of Table II to Division 15 of Part B and contains an agricultural chemical or any of its derivatives set out in column I of that Table,
(ii) is not set out in column IV of Table III to Division 15 of Part B and contains a veterinary drug set out in column I of that Table, or
(iii) is not set out in column II of any of Tables I to IV and VI to XV or in column III of Table V to section B.16.100, and contains a food additive set out in column I of that Table.
(3) The request referred to in subsection (1) shall be accompanied by the following information:
(a) the common name and description of the food;
(b) the reasons for which the exemption, the Notice of Interim Marketing Authorization and an amendment to these Regulations are required;
(c) a description of every proposed variation from the requirements of these Regulations;
(d) adequate data, including results of tests and scientific analysis, that demonstrate that the use of the food will not be detrimental to the health of the purchaser or user; and
(e) where the request relates to the addition of a vitamin, mineral nutrient or amino acid to the food, a statement, with supporting documentation, as to the consistency of the request with the General Principles for the Addition of Essential Nutrients to Foods adopted by the Joint Food and Agriculture Organization of the United Nations / World Health Organization Codex Alimentarius Commission and published in the Codex Alimentarius (Rome, 1996), as amended from time to time.
(4) Where the Director determines after examining the request and the information submitted under subsection (3) that use of the food will not be harmful to the health of the purchaser or user, the Director shall exempt the food from the application, in whole or in part, of the requirements relating to it under these Regulations and issue a conditional or unconditional Notice of Interim Marketing Authorization relating to the food. The Director shall also indicate his or her intention to recommend that these Regulations be amended in relation to the food.
(5) The Notice of Interim Marketing Authorization issued under subsection (4) shall set out
(a) the common name and description of the food;
(b) the reasons for which the exemption is established and the Notice of Interim Marketing Authorization issued; and
(c) such of the following as are applicable to the food:
(i) the maximum residue limit of any agricultural chemical or any of its derivatives, expressed in parts per million,
(ii) the maximum level of use of any food additive that the food is permitted to contain, or have on it, expressed in the applicable units of measurement,
(iii) the maximum residue limit of any veterinary drug, expressed in parts per million, and
(iv) the minimum and maximum limits for the addition of any vitamin, mineral nutrient or amino acid, expressed in the applicable units of measurement.
(6) The Notice of Interim Marketing Authorization issued under subsection (4) must be published in the Canada Gazette Part I and has effect beginning on the date of publication.
(7) The Director may, by a notice published in the Canada Gazette Part I, revoke an exemption and Notice of Interim Marketing Authorization relating to a food where the Director believes on reasonable grounds, after reviewing any information that comes to the attention of the Director, that use of the food is or may be harmful to the health of the purchaser or user.
(8) A Notice of Interim Marketing Authorization issued under subsection (4) in relation to a food loses its effect on the coming into force of any amendment to these Regulations resulting from the Director’s recommendation referred to in that subsection.
B.01.060 to B.01.066 [Repealed, SOR/88-559, s. 10]
B.01.070 [S]. Mixed nuts or a mixture of nuts shall consist of a mixture of nuts in which not less than five per cent by weight of each type of nuts is present in the mixture.
B.01.071 Where a prepackaged product is a mixture of nuts, the percentage and common name of the nut that is present in the product in the greatest amount by weight shall be applied to the principal display panel of the package in close proximity to the common name of the product.
B.01.072 Notwithstanding any requirement prescribed in Part B, a food product that has been subjected to heat in the presence of a vaporized liquid solution of smoke derived from hardwood, hardwood sawdust or corn cobs may be described as “smoked”.
B.01.080 (1) In this section, frozen means preserved by freezing temperature and does not include any surface freezing that may occur during holding and transportation.
(2) Where meat, meat by-products, poultry meat, poultry by-products or fish, or meat of any marine or fresh water animal, that has been frozen is thawed prior to sale, the words “previously frozen” shall be shown
(a) on the principal display panel in close proximity to the common name of the food and in letters at least as legible and conspicuous as those used in the common name;
(b) anywhere on the principal display panel in letters of not less than 1/4 of an inch (6.4 millimetres) in height; or
(c) on a sign displayed adjacent to the food in letters that are legible and conspicuous to a prospective purchaser.
(3) Where part of a food referred to in subsection (2) has been frozen and thawed prior to sale, the words “Made from fresh and frozen portions” or “Made from fresh and frozen (naming the food)” shall be shown in the manner described in paragraph (2)(a), (b) or (c).
B.01.090 (1) No person shall offer for sale at retail any solid cut meat or solid cut poultry meat to which phosphate salts or water has been added, unless that meat or poultry meat is contained in a package and carries a label.
(2) The label referred to in subsection (1) shall contain a statement of the minimum percentage of meat protein as part of the common name of the product on the principal display panel of the package in type that is as legible and conspicuous as any other type on that display panel, and in letters that are at least one half of the size of the letters used in the common name of the product but that are not less than 1.6 mm in height.
B.01.091 The label of any solid cut meat or solid cut poultry meat that has had phosphate salts or water added to it, that is not cured and that is prepackaged at retail shall contain a statement of the ingredients contained in the food in accordance with subsections B.01.008(3) to (5).
B.01.092 Sections B.01.090 and B.01.091 do not apply in respect of side bacon, Wiltshire bacon, pork jowls, salt pork or salt beef.
B.01.100 (1) The common name of a simulated meat product or simulated poultry product shall be the common name of the meat product or poultry product that is simulated, modified by the word “simulated”.
(2) The word “simulated” in the common name of a simulated meat product or simulated poultry product shall be shown in letters of at least the same size and prominence as those used in the remainder of the common name of that product.
(3) Where a simulated meat product or a simulated poultry product is not a prepackaged product, the common name of the product and the other information required by this section to be shown on the label of a simulated meat product or simulated poultry product shall be shown on a sign displayed on or adjacent to the product in letters that are legible and conspicuous to a prospective purchaser.
(4) The words
(a) “contains no meat”, in the case of a simulated meat product, and
(b) “contains no poultry”, in the case of a simulated poultry product,
shall be shown on the principal display panel of the label of a simulated meat product or simulated poultry product in close proximity to the common name and in letters of at least the same size and prominence as those shown in the common name.
(5) to (7) [Repealed, SOR/88-559, s. 11]
B.01.101 (1) For the purposes of this section and section B.01.102, source of protein means any food that contains protein, but does not include spices, seasonings, flavours, artificial flavours, flavour enhancers, food additives and similar foods that contain only small amounts of protein.
(2) The common name of a meat product extender shall be the common name of each food in the meat product extender that is a source of protein, plus
(a) the word “meat”, or the common name of the meat product that is to be extended, plus the word “extender”; or
(b) the words “extender for” plus the common name of the meat product that is to be extended.
(3) The common name of a poultry product extender shall be the common name of each food in the poultry product extender that is a source of protein, plus
(a) the word “poultry”, or the common name of the poultry product that is to be extended plus the word “extender”; or
(b) the words “extender for” plus the common name of the poultry product that is to be extended.
(4) Foods that are a source of protein in the meat product extender or poultry product extender shall be shown by their common names in the common name of that meat product extender or poultry product extender
(a) in descending order of their proportion of the meat product extender or poultry product extender; and
(b) in letters of at least the same size and prominence as those used in the remainder of the common name of the meat product extender or poultry product extender.
(5) and (6) [Repealed, SOR/88-559, s. 12]
B.01.102 (1) The common name of an extended meat product or an extended poultry product shall be the common name of the meat product or poultry product that is extended, modified by the common name of each of the foods that are sources of protein in the extended meat product or extended poultry product.
(2) Notwithstanding subsection (1),
(a) the word or words “meat”, “meat product”, “poultry”, “poultry meat” or “poultry meat by-product” as the case may be, may be used in the common name of an extended meat product or extended poultry product as the common name of the food therein that is a source of protein derived from a meat product or poultry product; and
(b) where it is an acceptable manufacturing practice for a manufacturer to omit from his meat product extender or poultry product extender any source of protein derived from a plant that is ordinarily an ingredient of that meat product extender or poultry product extender, or to substitute in whole or in part in his meat product extender or poultry product extender any source of protein derived from a plant for a source of protein that is ordinarily an ingredient of that meat product extender or poultry product extender, the word “plant” may be used in the common name of an extended meat product or extended poultry product as the common name of the food therein that is a source of protein derived from a plant.
(3) Foods that are a source of protein in an extended meat product or extended poultry product shall be shown by their common names in the common name of that product
(a) in descending order of their proportion of that product; and
(b) in letters of at least the same size and prominence as those used in the remainder of the common name of that product.
(4) Where an extended meat product or extended poultry product is not a prepackaged product, the common name of that product and the information required by this section to be shown on the label of an extended meat product or extended poultry product shall be shown on a sign displayed on or adjacent to that product in letters that are legible and conspicuous to a prospective purchaser.
(5) to (7) [Repealed, SOR/88-559, s. 13]
B.01.103 (1) The common name of a yolk-replaced egg shall be “yolk-replaced egg”.
(2) to (4) [Repealed, SOR/88-559, s. 14]
B.01.300 [Repealed, SOR/2003-11, s. 15]
B.01.301 (1) No person shall, on the label of or in any advertisement for a food, other than in the nutrition facts table, if any, include a declaration of the food’s energy value or the amount of a nutrient contained in the food unless it is declared in the following manner, per serving of stated size:
(a) in the case of the energy value, in Calories;
(b) in the case of a vitamin set out in column I of Table I to Division 1 of Part D or a mineral nutrient set out in column I of Table I to Division 2 of Part D, in the units specified in that column;
(c) in the case of sodium, potassium or cholesterol, in milligrams;
(d) in the case of the mineral ion content of prepackaged water or ice, in parts per million; and
(e) in any other case, in grams.
(2) Despite subsection (1), a person may, on the label of a food or in any advertisement for a food, other than in the nutrition facts table, if any, include a declaration of the percentage of the daily value of a nutrient contained in the food if
(a) the nutrient is listed in column 1 of the table to section B.01.401 or the table to section B.01.402;
(b) the percentage of the daily value of the nutrient is required or permitted to be declared in the nutrition facts table; and
(c) the percentage of the daily value of the nutrient is declared per serving of stated size.
(3) A declaration referred to in subsection (1) or (2) that appears on the label of a food shall be
(a) in English and French; or
(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.
B.01.302 to B.01.304 [Repealed, SOR/2003-11, s. 17]
B.01.305 (1) No person shall, on the label of or in any advertisement for a food, make a representation, express or implied, respecting a protein unless the food meets the conditions set out in column 2 of item 8 of the table following section B.01.513 for the subject “source of protein” set out in column 1.
(2) No person shall, on the label of or in any advertisement for a food, make a representation, express or implied, respecting an amino acid unless
(a) the food meets the conditions set out in column 2 of item 8 of the table following section B.01.513 for the subject “source of protein” set out in column 1; and
(b) the label or advertisement includes a declaration of the amount of histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine contained in the food, expressed in grams per serving of stated size.
(3) Subsections (1) and (2) do not apply in respect of
(a) a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute;
(b) foods represented for use in gluten-free diets, protein restricted diets, low (naming the amino acid) diets and (naming the amino acid) free diets;
(c) the word “protein” when used as part of the common name of an ingredient in the list of ingredients;
(d) the declaration of amino acids in the list of ingredients;
(e) the common names set out in column II of items 7 to 9 of the table to paragraph B.01.010(3)(a), when shown in the list of ingredients in accordance with that paragraph;
(f) the common name of a single amino acid preparation that may be sold as a food;
(g) the statements required by paragraphs B.01.014(c) and B.01.015(1)(b);
(h) a statement or claim set out in column 4 of item 7 of the table following section B.01.513 respecting the subject “low in protein” set out in column 1;
(i) a declaration of the amount of protein in the nutrition facts table;
(j) a statement of the protein content of a food as required by paragraph B.24.103(c), subparagraph B.24.202(a)(ii), paragraph B.24.304(b) or B.25.057(1)(a) or subparagraph B.25.057(2)(c)(i) or (d)(i); or
(k) a statement that a food is not a source of protein.
(4) A representation referred to in subsection (1) or (2) that appears on the label of a food shall be
(a) in English and French; or
(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.
B.01.306 to B.01.310 [Repealed, SOR/2003-11, s. 19]
B.01.311 (1) Subject to subsections (2) and (3), no person shall, on the label of or in any advertisement for a food, make a representation, express or implied, concerning the action or effect of the food’s energy value or of a nutrient contained in the food.
(2) The label of or advertisement for a food may carry a statement or claim set out in column 1 of the table following section B.01.603.
(3) Subject to section B.01.312, the label of or advertisement for a food may carry a statement or claim to the effect that the food’s energy value or a nutrient contained in the food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development.
(4) If a statement or claim described in subsection (3) concerns a nutrient not listed in column 1 of the tables to sections B.01.401 and B.01.402, the amount of the nutrient contained in the food must be expressed on any part of the label in grams per serving of stated size.
(5) A statement or claim referred to in subsection (2) or (3) that appears on the label of a food shall be
(a) in English and French; or
(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.
B.01.312 (1) If a statement or claim described in subsection B.01.311(3) is made on the label of or in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include a declaration, per serving of stated size, of
(a) the energy value, if the energy value is the subject of the statement or claim; or
(b) the amount of the nutrient, if a nutrient is the subject of the statement or claim.
(2) If the statement or claim is made in an advertisement other than a radio or television advertisement, the declaration referred to in subsection (1) shall be
(a) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and
(b) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.
(3) If the statement or claim is made in a radio advertisement or in the audio portion of a television advertisement, the declaration referred to in subsection (1) shall immediately precede or follow the statement or claim.
(4) If the statement or claim is made in a television advertisement, the declaration referred to in subsection (1) shall be communicated
(a) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions; or
(b) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.
(5) If the declaration referred to in subsection (1) is communicated in the visual mode of a television advertisement, it shall
(a) appear concurrently with and for at least the same amount of time as the statement or claim;
(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and
(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.
Interpretation
B.01.400 The following definitions apply in sections B.01.401 to B.01.603.
fat
fat means all fatty acids expressed as triglycerides. (lipides)
point
point means a unit of measurement for type size that is known as an Anglo-American point and is equal to 0.3514598 mm. (point)
Nutrition Labelling
Core Information
B.01.401 (1) Except as otherwise provided in this section and sections B.01.402 to B.01.406 and B.01.467, the label of a prepackaged product shall carry a nutrition facts table that contains only the information set out in column 1 of the table to this section expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4.
(2) Subsection (1) does not apply to a prepackaged product if
(a) all the information set out in column 1 of the table to this section, other than in respect of item 1 (“Serving of stated size”), may be expressed as “0” in the nutrition facts table in accordance with this section;
(b) the product is
(i) a beverage with an alcohol content of more than 0.5%,
(ii) a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with paraffin wax or petrolatum,
(iii) a raw single ingredient meat, meat by-product, poultry meat or poultry meat by-product,
(iv) a raw single ingredient marine or fresh water animal product,
(v) sold only in the retail establishment where the product is prepared and processed from its ingredients, including from a pre-mix if an ingredient other than water is added to the pre-mix during the preparation and processing of the product,
(vi) sold only at a road-side stand, craft show, flea market, fair, farmers’ market or sugar bush by the individual who prepared and processed the product,
(vii) an individual serving that is sold for immediate consumption and that has not been subjected to a process to extend its durable life, including special packaging, or
(viii) sold only in the retail establishment where the product is packaged, if the product is labelled by means of a sticker and has an available display surface of less than 200 cm2; or
(c) the product is
(i) a prepackaged confection, commonly known as a one bite confection, that is sold individually,
(ii) a prepackaged individual portion of food that is solely intended to be served by a restaurant or other commercial enterprise with meals or snacks, or
(iii) milk, partly skimmed milk, skim milk, goat’s milk, partly skimmed goat’s milk, skimmed goat’s milk, (naming the flavour) milk, (naming the flavour) partly skimmed milk, (naming the flavour) skim milk or cream sold in a refillable glass container.
(3) Despite paragraphs (2)(a) and (b), subsection (1) applies to a prepackaged product if
(a) the product contains an added vitamin or mineral nutrient;
(b) a vitamin or mineral nutrient is declared as a component of one of the product’s ingredients other than flour;
(c) the product contains added aspartame, sucralose or acesulfame-potassium;
(d) the product is a meat, meat by-product, poultry meat or poultry meat by-product that is ground; or
(e) the label of the product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains
(i) a reference to the energy value, a nutrient set out in column 1 of the table to this section or in column 1 of the table to section B.01.402 or a constituent of such a nutrient, other than information required by Division 12 or a reference to the common name of an ingredient in the list of ingredients for the product,
(ii) a representation that expressly or implicitly indicates that the product has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the table following section B.01.513 or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004,
(iii) a health-related name, statement, logo, symbol, seal of approval or mark, or
(iv) the phrase “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.
(4) Subsection (1) does not apply to a formulated liquid diet, a human milk substitute, a food represented as containing a human milk substitute, a meal replacement, a nutritional supplement or a food represented for use in a very low energy diet.
(5) The label of or advertisement for a formulated liquid diet, a human milk substitute, a food represented as containing a human milk substitute, a meal replacement, a nutritional supplement or a food represented for use in a very low energy diet shall not contain a nutrition facts table or the phrase “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.
(6) If, for a prepackaged product other than one intended solely for children under two years of age, the information in respect of seven or more of the energy value and nutrients referred to in column 1 of items 2 to 5 and 7 to 13 of the table to this section may be expressed as “0” in the nutrition facts table in accordance with this section, the nutrition facts table need only include the following information:
(a) the serving of stated size;
(b) the energy value;
(c) the amount of fat;
(d) the amount of carbohydrate;
(e) the amount of protein;
(f) the amount of any nutrient that is the subject of a representation referred to in subparagraph (3)(e)(ii);
(g) the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, other than iodide added to salt for table or general household use or fluoride added to prepackaged water or ice;
(h) the amount of any vitamin or mineral nutrient that is declared as a component of one of the prepackaged product’s ingredients other than flour;
(i) the amount of any nutrient referred to in column 1 of item 4, 5, 7, 8, 10, 11 or 13 of the table to this section that may not be expressed as “0” in the nutrition facts table; and
(j) the statement “Not a significant source of (naming each nutrient that is omitted from the nutrition facts table in accordance with this subsection)” or, if the prepackaged product meets the condition specified in subsection B.01.455(3), the statement “Not a significant source of other nutrients”.
(7) Subsection (1) does not apply to a prepackaged product
(a) that is intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or institution; or
(b) that is a multiple-serving ready-to-serve prepackaged product intended solely to be served in a commercial or industrial enterprise or institution.
TABLE
CORE INFORMATION
Column 1Column 2Column 3Column 4ItemInformationDescriptionUnitManner of expression 1Serving of stated size“Serving Size (naming the serving size)”, “Serving (naming the serving size)” or “Per (naming the serving size)”(1) The size is expressed in one of the following units:
(a) in the case of a food that is usually divided into pieces before being consumed (such as cake, pie and pizza), a fraction of the entire food;
(b) in the case of a food described in subsection B.01.002A(2), the entire container; and
(c) in all other cases, in a commonly used unit in respect of which the quantity is visibly measurable, such as millilitres, cups, tablespoons or “(naming the unit of food)”.
(2) The size expressed in accordance with subitem (1) is followed by the size expressed in grams or millilitres, as specified by paragraph B.01.002A(1)(b).
(1) The size when expressed in metric units is rounded off
(a) if it is less than 10 g or 10 mL, to the nearest multiple of 0.1 g or0.1 mL; and
(b) if it is 10 g or more or 10 mL or more, to the nearest multiple of 1 g or 1 mL.
(2) The size when expressed as a fraction is represented by a numerator and a denominator separated by a line.
(3) The size shall include the word “assorted” if the information in the nutrition facts table of a prepackaged product that contains an assortment of foods is set out as a composite value.
The value is rounded off
(a) if it is less than 5 Calories
(i) if the product meets the conditions set out in column 2 of item 1 of the table following section B.01.513 for the subject” free of energy” set out in column 1, to “0” Calorie, and
(ii) in all other cases, to the nearest multiple of 1 Calorie;
(b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and
(c) if it is more than 50 Calories, to the nearest multiple of 10 Calories.
The amount is expressed
(a) in grams per serving of stated size; and
(b) as a percentage of the daily value per serving of stated size.
(1) The amount is rounded off
(a) if it is less than 0.5 g
(i) if the product meets the conditions set out in column 2 of item 11 of the table following section B.01.513 for the subject “free of fat” set out in column 1 and the amounts of saturated fatty acids and trans fatty acids are declared as “0 g” in the nutrition facts table or are omitted from that table in accordance with subsection B.01.401(6) and no other fatty acids are declared in an amount greater than 0 g, to “0 g”, and
(ii) in all other cases, to the nearest multiple of 0.1 g;
(b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
(2) The percentage is rounded off
(a) if the amount is declared as “0 g”, to “0 %“; and
(b) in all other cases, to the nearest multiple of 1%.
The amount is rounded off
(a) if it is less than 0.5 g
(i) if the product meets the conditions set out in column 2 of item 18 of the table following section B.01.513 for the subject “free of saturated fatty acids” set out in column 1, to “0 g”, and
(ii) in all other cases, to the nearest multiple of 0.1 g;
(b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
The amount is rounded off
(a) if it is less than 0.5 g
(i) if the product meets the conditions set out in column 2 of item 22 of the table following section B.01.513 for the subject “free of trans fatty acids” set out in column 1, to “0 g”, and
(ii) in all other cases, to the nearest multiple of 0.1 g;
(b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
The percentage is rounded off
(a) if the amounts of saturated fatty acids and trans fatty acids are declared as “0 g”, to “0 %”; and
(b) in all other cases, to the nearest multiple of 1%.
(1) The amount is rounded off
(a) if the product meets the conditions set out in column 2 of item 27 of the table following section B.01.513 for the subject “free of cholesterol” set out in column 1, to “0 mg”; and
(b) in all other cases, to the nearest multiple of 5 mg.
(2) The percentage is rounded off
(a) if the amount is declared as “0 mg” to “0 %”; and
(b) in all other cases, to the nearest multiple of 1%.
The amount is expressed
(a) in milligrams per serving of stated size; and
(b) as a percentage of the daily value per serving of stated size.
(1) The amount is rounded off(
a) if it is less than 5 mg
(i) if the product meets the conditions set out in column 2 of item 31 of the table following section B.01.513 for the subject “free of sodium or salt” set out in column 1, to “0 mg”, and
(ii) in all other cases, to the nearest multiple of 1 mg;
(b) if it is 5 mg or more but not more than 140 mg, to the nearest multiple of 5 mg; and
(c) if it is more than 140 mg, to the nearest multiple of 10 mg.
(2) The percentage is rounded off
(a) if the amount is declared as “0 mg”, to “0 %”; and
(b) in all other cases, to the nearest multiple of 1%.
The amount is expressed
(a) in grams per serving of stated size; and
(b) as a percentage of the daily value per serving of stated size.
(1) The amount is rounded off
(a) if it is less than 0.5 g, to “0 g”; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
(2) The percentage is rounded off
(a) if the amount is declared as “0 g”, to “0 %”; and
(b) in all other cases, to the nearest multiple of 1%.
The amount is expressed
(a) in grams per serving of stated size; and
(b) as a percentage of the daily value per serving of stated size.
(1) The amount is rounded off
(a) if it is less than 0.5 g, to “0 g”; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
(2) The percentage is rounded off
(a) if the amount is declared as “0 g”, to “0 %”; and
(b) in all other cases, to the nearest multiple of 1%.
The amount is rounded off
(a) if it is less than 0.5 g, to “0 g”; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
The amount is rounded off
(a) if it is less than 0.5 g, to the nearest multiple of 0.1 g; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
Amount of
The amount is expressed as a percentage of the daily value per serving of stated size.The percentage is rounded off
(a) if it is less than 2%
(i) if the product contains less than 1% of the daily value per reference amount and per serving of stated size, to “0 %”, and
(ii) in all other cases, to “2 %”;
(b) if it is 2% or more but not more than 10%, to the nearest multiple of 2%;
(c) if it is more than 10% but not more than 50%, to the nearest multiple of 5%; and
(d) if it is more than 50%, to the nearest multiple of 10%.
(a) vitamin A
(a) “Vitamin A” or “Vit A”
(b) vitamin C
(b) “Vitamin C” or “Vit C”
(c) calcium
(c) “Calcium”
(d) iron
(d) “Iron”
Additional Information
B.01.402 (1) The nutrition facts table may also contain information set out in column 1 of the table to this section.
(2) If information set out in column 1 of the table to this section is included in the nutrition facts table, it shall be expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4.
(3) The amount of omega-6 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids and monounsaturated fatty acids shall be in the nutrition facts table if
(a) the amount of any of those groups of fatty acids or the amount of polyunsaturated fatty acids is in the nutrition facts table or is shown on the label of the prepackaged product or in any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product; or
(b) the amount of any specific fatty acid is shown on the label of the prepackaged product or in any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product.
(4) If the label of a prepackaged product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains a representation, express or implied, that includes information that is set out in column 1 of the table to this section, that information shall also be in the nutrition facts table.
(5) The amount of potassium shall be in the nutrition facts table if the prepackaged product contains added potassium salts and the label of the product or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product contains a statement or claim referred to in column 4 of any of items 31 to 36 of the table following section B.01.513 for the subject “free of sodium or salt”, “low in sodium or salt”, “reduced in sodium or salt”, “lower in sodium or salt”, “no added sodium or salt” or “lightly salted” set out in column 1.
(6) The nutrition facts table shall show the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, except in the case of iodide added to salt for table or general household use or fluoride added to prepackaged water or ice.
(7) The nutrition facts table shall show the amount of any vitamin or mineral nutrient that is declared as a component of one of the prepackaged product’s ingredients other than flour.
(8) Despite subsection (1) and item 1 of the table to this section, the nutrition facts table shall not include information on servings per container if the serving of stated size is expressed in cups or tablespoons.
(9) If information set out in column 1 of the table to this section is included in the nutrition facts table, it shall be shown
(a) in English and French; or
(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the product may be shown in that language only and is shown on the label in that language.
TABLE
Additional Information
ItemColumn 1Column 2Column 3Column 4InformationDescriptionUnitManner of expression1Servings per container“Servings Per Container” or “(number of units) Per Container”The quantity is expressed in number of servings.(1) The quantity is rounded off
(a) if it is less than 2, to the nearest multiple of 1;
(b) if it is between 2 and 5, to the nearest multiple of 0.5; and
(c) if it is more than 5, to the nearest multiple of 1.
(2) If a quantity is rounded off, it shall be preceded by the word “about”.
(3) If the product is of a random weight, the quantity may be declared as “varied”.
The value is rounded off
(a) if it is less than 5 Calories
(i) if the amount of fat is declared as “0 g” in the nutrition facts table, to “0” Calorie, and
(ii) in all other cases, to the nearest multiple of 1 Calorie;
(b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and
(c) if it is more than 50 Calories, to the nearest multiple of 10 Calories.
The value is rounded off
(a) if it is less than 5 Calories
(i) if the amounts of saturated fatty acids and trans fatty acids are declared as “0 g” in the nutrition facts table, to “0” Calorie, and
(ii) in all other cases, to the nearest multiple of Calorie;
(b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and
(c) if it is more than 50 Calories, to the nearest multiple of 10 Calories.
The amount is rounded off
(a) if it is less than 1 g, to the nearest multiple of 0.1 g;
(b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
(1) If the nutrition facts table includes the amount of polyunsaturated fatty acids: “Omega-6”, “Omega-6 Polyunsaturated Fat”, “Omega-6 Polyunsaturated Fatty Acids”, “Omega-6 Polyunsaturates” or “Omega-6 Polyunsaturate
(2) In all other cases: “Omega-6 Polyunsaturated Fat”, “Omega-6 Polyunsaturated Fatty Acids”, “Omega-6 Polyunsaturates” or “Omega-6 Polyunsaturated”
The amount is rounded off
(a) if it is less than 1 g, to the nearest multiple of 0.1 g;
(b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
(1) If the nutrition facts table includes the amount of polyunsaturated fatty acids: “Omega-3”, “Omega-3 Polyunsaturated Fat”, “Omega-3 Polyunsaturated Fatty Acids”, “Omega-3 Polyunsaturates” or “Omega-3 Polyunsaturated”
(2) In all other cases: “Omega-3 Polyunsaturated Fat”, “Omega-3 Polyunsaturated Fatty Acids”, “Omega-3 Polyunsaturates” or “Omega-3 Polyunsaturated”
The amount is rounded off
(a) if it is less than 1 g, to the nearest multiple of 0.1 g;
(b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
The amount is rounded off
(a) if it is less than 1 g, to the nearest multiple of 0.1 g;
(b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and
(c) if it is more than 5 g, to the nearest multiple of 1 g.
The amount is expressed
(a) in milligrams per serving of stated size; and
(b) as a percentage of the daily value per serving of stated size.
(1) The amount is rounded off
(a) if it is less than 5 mg
(i) if the product contains less than 5 mg of potassium per reference amount and per serving of stated size, to “0 mg”, and
(ii) in all other cases, to the nearest multiple of 1 mg;
(b) if it is 5 mg or more but not more than 140 mg, to the nearest multiple of 5 mg; and
(c) if it is more than 140 mg, to the nearest multiple of 10 mg.
(2) The percentage is rounded off
(a) if the amount is declared as “0 mg”, to “0%”; or
(b) in all other cases, to the nearest multiple of 1%.
The amount is rounded off
(a) if it is less than 0.5 g, to “0 g”; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
The amount is rounded off
(a) if it is less than 0.5 g, to “0 g”; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
(1) If the food contains only one type of sugar alcohol: “Sugar Alcohol”, “Polyol” or “(naming the sugar alcohol)”
(2) In all other cases: “Sugar Alcohols” or “Polyols”
The amount is rounded off
(a) if it is less than 0.5 g, to “0 g”; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
The amount is rounded off
(a) if it is less than 0.5 g, to “0 g”; and
(b) if it is 0.5 g or more, to the nearest multiple of 1 g.
Amount of
(a) vitamin D
(b) vitamin E
(c) vitamin K
(d) thiamine
(e) riboflavin
(f) niacin
(g) vitamin B6
(h) folate
(i) vitamin B12
(j) biotin
(k) pantothenic acid
(l) phosphorus
(m) iodide
(n) magnesium
(o) zinc
(p) selenium
(q) copper
(r) manganese
(s) chromium
(t) molybdenum
(u) chloride
(a) “Vitamin D” or “Vit D”
(b) “Vitamin E” or “Vit E”
(c) “Vitamin K” or “Vit K”
(d) “Thiamine”, “Thiamin”, “Thiamine (Vitamin B1)”, “Thiamine (Vit B1)”, “Thiamin (Vitamin B1)” or “Thiamin (Vit B1)”
(e) “Riboflavin”, “Riboflavin (Vitamin B2)” or “Riboflavin (Vit B2)”
(f) “Niacin”
(g) “Vitamin B6” or “Vit B6“
(h) “Folate”
(i) “Vitamin B12“ or “Vit B12”
(j) “Biotin”
(k) “Pantothenic Acid” or “Pantothenate”
(l) “Phosphorus”
(m) “Iodide” or “Iodine”
(n) “Magnesium”
(o) “Zinc”
(p) “Selenium”
(q) “Copper”
(r) “Manganese”
(s) “Chromium”
(t) “Molybdenum”
(u) “Chloride”
The percentage is rounded off
(a) if it is less than 2%
(i) if the product contains less than 1% of the daily value per reference amount and per serving of stated size, to “0%”, and
(ii) in all other cases, to the nearest multiple of 2%;
(b) if it is 2% or more but not more than 10%, to the nearest multiple of 2%;
(c) if it is more than 10% but not more than 50%, to the nearest multiple of 5%; and
(d) if it is more than 50%, to the nearest multiple of 10%.
In the version of the footnote that refers to nutrients,
(a) the daily value for potassium is included only if the amount of potassium is declared in the nutrition facts table; and
(b) the daily value for cholesterol is included only if the amount of cholesterol is declared in the nutrition facts table as a percentage of the daily value per serving of stated size.
Foods for Children under Two Years of Age
B.01.403 (1) This section applies in respect of a prepackaged product intended solely for children under two years of age.
(2) The nutrition facts table of the product shall not contain
(a) the percentage of the daily value of fat, cholesterol, sodium, potassium, carbohydrate or fibre or of the sum of saturated fatty acids and trans fatty acids;
(b) the energy value from fat or from the sum of saturated fatty acids and trans fatty acids; or
(c) any of the footnotes to the subheading “% Daily Value” set out in Figures 18.1(E) and (F) in Schedule L.
(3) The nutrition facts table of the product may omit the amount of saturated fatty acids, trans fatty acids and cholesterol.
(4) Despite subsection (3), if the amount of cholesterol is in the nutrition facts table, the amounts of saturated fatty acids and trans fatty acids shall also be in the nutrition facts table.
(5) If the information in respect of six or more of the energy value and nutrients referred to in column 1 of items 2, 3 and 8 to 13 of the table to section B.01.401 may be expressed as “0” in the nutrition facts table of the product in accordance with that section, the nutrition facts table need only include the following information:
(a) the serving of stated size;
(b) the energy value;
(c) the amount of fat;
(d) the amount of carbohydrate;
(e) the amount of protein;
(f) the amount of any nutrient that is the subject of a representation referred to in subparagraph B.01.401(3)(e)(ii);
(g) the amount of any sugar alcohol, vitamin or mineral nutrient added to the product, other than fluoride added to prepackaged water or ice;
(h) the amount of any vitamin or mineral nutrient that is declared as a component of one of the product’s ingredients other than flour;
(i) the amount of any nutrient referred to in column 1 of item 8, 10, 11 or 13 of the table to section B.01.401 that may not be expressed as “0” in the nutrition facts table;
(j) except in the case described in paragraph (k), the statement “Not a significant source of (naming each nutrient that is omitted from the nutrition facts table in accordance with this subsection)”, but such a statement may be omitted in respect of saturated fatty acids, trans fatty acids and cholesterol; and
(k) if the product meets the condition specified in subsection B.01.462(3), the statement “Not a significant source of other nutrients” or the statement referred to in paragraph (j).
Food for Use in Manufacturing other Foods
B.01.404 (1) This section applies to a prepackaged product that is intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or institution.
(2) No person shall sell the product unless written nutrition information concerning the product accompanies the product when it is delivered to the purchaser.
(3) The nutrition information
(a) shall include the information that would, but for subsection B.01.401(7), be required by sections B.01.401 and B.01.402 to be included in a nutrition facts table for the product;
(b) may include other information that is permitted by section B.01.402 to be included in that nutrition facts table; and
(c) shall be expressed in accordance with sections B.01.401 and B.01.402, subject to the following modifications, namely,
(i) information for vitamins set out in column I of Table I to Division 1 of Part D and mineral nutrients set out in column I of Table I to Division 2 of that Part shall be expressed in the applicable units referred to in that column,
(A) per gram or 100 grams of the food, if the net quantity of the food is declared on the label by weight or by count, or
(B) per millilitre or 100 millilitres of the food, if the net quantity of the food is declared on the label by volume,
(ii) information for other nutrients and the energy value set out in column 1 of the table to section B.01.401 or in column 1 of the table to section B.01.402 shall be expressed in the units referred to in column 3,
(A) per gram or 100 grams of the food, if the net quantity of the food is declared on the label by weight or by count, or
(B) per millilitre or 100 millilitres of the food, if the net quantity of the food is declared on the label by volume,
(iii) percentages of daily values and information on servings of stated size may be omitted, and
(iv) the nutrition information shall be stated with a degree of precision that corresponds to the accuracy of the analytical methodology used to produce the information.
Foods for Enterprise or Institution
B.01.405 (1) This section applies to a prepackaged product that is a multiple-serving ready-to-serve prepackaged product intended solely to be served in a commercial or industrial enterprise or institution.
(2) No person shall sell the product unless written nutrition information concerning the product accompanies the product when it is delivered to the purchaser.
(3) The nutrition information
(a) shall include the information that would, but for subsection B.01.401(7), be required by sections B.01.401 and B.01.402 to be included in a nutrition facts table for the product;
(b) may include other information that is permitted by section B.01.402 to be included in that nutrition facts table; and
(c) shall be expressed in accordance with sections B.01.401 and B.01.402.
Basis of Information
B.01.406 (1) Subject to subsections (2) to (8), the information in the nutrition facts table shall be set out only on the basis of the prepackaged product as offered for sale.
(2) If a prepackaged product contains separately packaged ingredients or foods that are intended to be consumed together, the information in the nutrition facts table shall be set out for each ingredient or food or for the entire product.
(3) If a prepackaged product contains an assortment of foods of the same type and the typical serving consists of only one of those foods, the information in the nutrition facts table shall be set out
(a) on the basis of each of the foods contained in the product, if the nutrition information set out in column 1 of the table to section B.01.401 for each of those foods is different; or
(b) on the basis of one of the foods contained in the product, if the nutrition information set out in column 1 of the table to section B.01.401 for each of those foods is the same.
(4) If a prepackaged product contains an assortment of foods of the same type and the typical serving consists of more than one of those foods, the information in the nutrition facts table shall be set out for each of the foods contained in the product or as a composite value.
(5) If a prepackaged product contains a food that is to be prepared in accordance with directions provided in or on the package or that is commonly combined with other ingredients or another food or cooked before being consumed, the nutrition facts table may also set out information for the food as prepared, in which case
(a) the nutrition facts table shall set out the following information for the food as prepared, namely,
(i) except in the case described in subparagraph (ii), the amount of the food expressed in a unit specified in column 3 of paragraph 1(1)(a) or (c) of the table to section B.01.401 as “about (naming the serving size)” or “about (naming the serving size) prepared” and, if applicable, in the manner specified in column 4 of subitems 1(1) and (2),
(ii) if the food is commonly served combined with another food, the amount of the other food expressed in a unit specified in column 3 of paragraph 1(1)(c) of the table to section B.01.401 and, if applicable, in the manner specified in column 4 of subitem 1(1),
(iii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.01.401, in the unit set out in column 3 and in the manner set out in column 4,
(iv) if it is declared in the nutrition facts table for the food as sold, the energy value from fat, expressed using a description set out in column 2 of item 3 of the table to section B.01.402, in the unit set out in column 3 and in the manner set out in column 4, and
(v) the information set out in column 1 of items 3, 6 to 10 and 13 of the table to section B.01.401 and in column 1 of items 9 and 14 of the table to section B.01.402 that is declared as a percentage of the daily value in the nutrition facts table for the food as sold, expressed using a description set out in column 2, as a percentage of the daily value per serving of stated size and in the manner specified in column 4; and
(b) the nutrition facts table may also set out the following information for the added ingredients or the other food, if it is declared in the nutrition facts table for the food as sold, namely,
(i) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.01.401, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7 and 8 and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4, and
(ii) the information set out in column 1 of items 5 to 13 of the table to section B.01.402, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of item 9 and in grams for the information set out in column 1 of items 5 to 8 and 10 to 13 and in the manner specified in column 4.
(6) Subsection (5) does not apply in respect of a prepackaged product that is intended solely for children under two years of age.
(7) Subject to subsection (8), the information in the nutrition facts table may also be set out on the basis of other amounts of a food that reflect different uses or different units of measurement of a food, in which case
(a) the nutrition facts table shall set out the following information for each of the other amounts of food, namely,
(i) the amount of the food expressed in a unit specified in column 3 of subitem 1(1) of the table to section B.01.401 and, if applicable, in the manner specified in column 4 of subitems 1(1) and (2),
(ii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.01.401, in the unit set out in column 3 and in the manner set out in column 4,
(iii) if it is declared in the nutrition facts table for the first amount of food for which information is declared, the energy value from fat, expressed using a description set out in column 2 of item 3 of the table to section B.01.402, in the unit set out in column 3 and in the manner set out in column 4, and
(iv) the information set out in column 1 of items 3, 6 to 10 and 13 of the table to section B.01.401 and in column 1 of items 9 and 14 of the table to section B.01.402 that is declared as a percentage of the daily value in the nutrition facts table for the first amount of food for which information is declared, expressed using a description set out in column 2, as a percentage of the daily value per serving of stated size and in the manner specified in column 4;
(b) if the nutrition facts table is set out in a version of the dual format specified in section B.01.458, it may also set out the amount of each of the other amounts of food expressed in the unit specified in column 3 of subitem 1(2) of the table to section B.01.401 and in the manner specified in column 4 of subitem 1(1), if that information is declared in the nutrition facts table for the first amount of food for which information is declared; and
(c) if the nutrition facts table is set out in a version of the aggregate format specified in section B.01.459 or B.01.464, it shall also set out the following information for each of the other amounts of food, if that information is declared in the nutrition facts table for the first amount of food for which information is declared, namely,
(i) the amount of the food expressed in the unit specified in column 3 of subitem 1(2) of the table to section B.01.401 and in the manner specified in column 4 of subitem 1(1),
(ii) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.01.401, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7 and 8 and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4, and
(iii) the information set out in column 1 of items 5 to 13 of the table to section B.01.402, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of item 9 and in grams for the information set out in column 1 of items 5 to 8 and 10 to 13 and in the manner specified in column 4.
(8) If the nutrition facts table of a prepackaged product that is intended solely for children under two years of age sets out information in accordance with subsection (7), it shall set out the information referred to in paragraphs (7)(a) and (c).
[B.01.407 to B.01.449 reserved]
Presentation of Nutrition Facts Table
B.01.450 (1) Subject to subsections (2) to (6), the nutrition facts table shall be presented in accordance with the format specified in the applicable figure in Schedule L, having regard to matters such as order of presentation, dimensions, spacing and the use of upper and lower case letters and bold type.
(2) The characters and rules in the nutrition facts table shall be displayed in a single colour that is a visual equivalent of 100% solid black type on a white background or on a uniform neutral background with a maximum 5% tint of colour.
(3) The characters in the nutrition facts table
(a) shall be displayed in a single standard sans serif font that is not decorative and in such a manner that the characters never touch each other or the rules; and
(b) may be displayed with larger dimensions than those specified in the applicable figure in Schedule L if all the characters in the table are enlarged in a uniform manner.
(4) A rule that is specified in the applicable figure in Schedule L as being a 1 point rule or a 2 point rule may be displayed with larger dimensions in the nutrition facts table.
(5) The information in the nutrition facts table shall be in accordance with sections B.01.400 to B.01.403 and B.01.406.
(6) In a nutrition facts table consisting of a table in both English and French, the order of languages may be reversed from the order shown in the applicable figure in Schedule L.
Location of Nutrition Facts Table
B.01.451 (1) Subject to subsection (2), the nutrition facts table shall be displayed on the label of the prepackaged product
(a) in a table in English and a table in French on the same continuous surface of the available display surface;
(b) in a table in both English and French on a continuous surface of the available display surface; or
(c) in a table in English on a continuous surface of the available display surface and a table in French on another continuous surface of the available display surface that is of the same size and prominence as the first surface.
(2) If in accordance with subsection B.01.012(3) or (7) the information required by these Regulations may be shown on the label of a prepackaged product in English only or in French only and is shown in that language, the nutrition facts table may be displayed on the label of the prepackaged product in a table in that language only on a continuous surface of the available display surface.
Orientation of Nutrition Facts Table
B.01.452 (1) Subject to subsection (2), the nutrition facts table shall be oriented in the same manner as other information appearing on the label of the prepackaged product.
(2) If a version of a nutrition facts table cannot be oriented in the same manner as other information appearing on the label of the prepackaged product, it shall be oriented in another manner if there is sufficient space to do so and the food contained in the package does not leak out and is not damaged when the package is turned over.
(3) Subsection (1) does not apply in respect of a nutrition facts table that is set out on the top or bottom of a prepackaged product.
Application
B.01.453 (1) Sections B.01.454 to B.01.460 apply to prepackaged products other than those that are intended solely for children under two years of age.
(2) Sections B.01.461 to B.01.465 apply to prepackaged products that are intended solely for children under two years of age.
Standard and Horizontal Formats
B.01.454 (1) This section applies to a prepackaged product unless any of sections B.01.455 to B.01.459 applies to the product.
(2) Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in
(a) the bilingual standard format in accordance with Figure 3.5(B), 3.6(B) or 3.7(B) of Schedule L;
(b) the bilingual horizontal format in accordance with Figure 4.3(B), 4.4(B) or 4.5(B) of Schedule L;
(c) the linear format in accordance with Figures 16.1(E) and (F) or 16.2(E) and (F) of Schedule L;
(d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or
(e) a manner described in section B.01.466.
(4) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included in that table.
(5) Despite subsections (2) and (3), if the prepackaged product is sold only in the retail establishment where the product is packaged, is labelled by means of a sticker and has an available display surface of 200 cm2 or more, its nutrition facts table shall be set out in a version that is listed in column 1 of items 1 to 3 of Parts 1 to 3 of the table to this section, without regard to any condition specified in column 2.
(6) Despite subsections (2) and (3), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.
TABLE
PART 1
Standard Format
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use11.1(E) and (F)(8 point type with 12 point leading)21.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)31.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)41.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)51.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)61.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
Narrow Standard Format
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use12.1(E) and (F)(8 point type with 12 point leading)22.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)32.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)42.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)PART 3
Bilingual Standard Format
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use13.1(B)(8 point type with 12 point leading)23.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)33.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)43.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)PART 4
Bilingual Horizontal Format
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use14.1(B)The versions in Parts 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)24.2(B)The versions in Parts 1 to 3 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Simplified Formats
B.01.455 (1) This section applies to a prepackaged product if it satisfies the condition set out in subsection B.01.401(6) and its nutrition facts table includes only the information referred to in paragraphs B.01.401(6)(a) to (j).
(2) Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table containing only the information referred to in paragraphs B.01.401(6)(a) to (j) in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in
(a) the bilingual simplified standard format in accordance with Figure 6.5(B) or 6.6(B) of Schedule L;
(b) the bilingual simplified horizontal format in accordance with Figure 7.3(B) or 7.4(B) of Schedule L;
(c) the simplified linear format in accordance with Figures 17.1(E) and (F) or 17.2(E) and (F) of Schedule L;
(d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or
(e) a manner described in section B.01.466.
(4) Despite subsections (2) and (3), if the prepackaged product is sold only in the retail establishment where the product is packaged, is labelled by means of a sticker and has an available display surface of 200 cm2 or more, its nutrition facts table shall be set out in a version that is listed in column 1 of items 1 to 3 of Parts 1 and 2 of the table to this section, without regard to any condition specified in column 2.
(5) Despite subsections (2) and (3), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.
TABLE
PART 1
Simplified Standard Format
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use15.1(E) and (F)(8 point type with 12 point leading)25.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)35.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)45.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)55.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)65.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
Bilingual Simplified Standard Format
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use16.1(B)(8 point type with 12 point leading)26.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)36.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)46.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)PART 3
Bilingual Simplified Horizontal Format
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use17.1(B)The versions in Parts 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)27.2(B)The versions in Parts 1 and 2 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Dual Format — Foods Requiring Preparation
B.01.456 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes information referred to in subsection B.01.406(5), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in
(a) the bilingual dual format in accordance with Figure 9.5(B) or 9.6(B) of Schedule L; or
(b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.
(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included in the table, together with the information referred to in subsection B.01.406(5).
(4) Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.
TABLE
PART 1
Dual Format — Foods Requiring Preparation
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use18.1(E) and (F)(8 point type with 12 point leading)28.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)38.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)48.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)58.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)68.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
Bilingual Dual Format — Foods Requiring Preparation
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use19.1(B)(8 point type with 12 point leading)29.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)39.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)49.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Aggregate Format — Different Kinds of Foods
B.01.457 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes separate information for each food or ingredient as provided in subsection B.01.406(2), paragraph B.01.406(3)(a) or subsection B.01.406(4), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out
(a) in the case of a product described in subsection B.01.406(2) or (4), in
(i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of Schedule L, or
(ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or
(b) in the case of a product described in paragraph B.01.406(3)(a), in
(i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of Schedule L,
(ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or
(iii) a manner described in section B.01.466.
(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each food or ingredient for which separate information is set out in the table.
(4) Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in subparagraph (2)(a)(i) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.
TABLE
PART 1
AGGREGATE FORMAT — DIFFERENT KINDS OF FOODS
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use110.1(E) and (F)(8 point type with 12 point leading)210.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)310.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)410.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)510.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)610.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
BILINGUAL AGGREGATE FORMAT — DIFFERENT KINDS OF FOODS
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use111.1(B)(8 point type with 12 point leading)211.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)311.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)411.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Dual Format — Different Amounts of Food
B.01.458 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes separate information for different amounts of the food as provided in paragraph B.01.406(7)(a) without including the information referred to in paragraph B.01.406(7)(c), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in
(a) the bilingual dual format in accordance with Figure 13.5(B) or 13.6(B) of Schedule L; or
(b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.
(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each amount of the food for which separate information is set out in the table.
(4) Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.
TABLE
PART 1
DUAL FORMAT — DIFFERENT AMOUNTS OF FOOD
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use112.1(E) and (F)(8 point type with 12 point leading)212.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)312.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)412.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)512.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)612.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
BILINGUAL DUAL FORMAT — DIFFERENT AMOUNTS OF FOOD
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use113.1(B)(8 point type with 12 point leading)213.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)313.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)413.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Aggregate Format — Different Amounts of Food
B.01.459 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product includes separate information for different amounts of the food as provided in paragraphs B.01.406(7)(a) and (c), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in
(a) the bilingual aggregate format in accordance with Figure 15.5(B) or 15.6(B) of Schedule L; or
(b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.
(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each amount of the food for which separate information is set out in the table.
(4) Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.
TABLE
PART 1
AGGREGATE FORMAT — DIFFERENT AMOUNTS OF FOOD
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use114.1(E) and (F)(8 point type with 12 point leading)214.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)314.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)4,14.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)514.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)614.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
BILINGUAL AGGREGATE FORMAT — DIFFERENT AMOUNTS OF FOOD
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use115.1(B)(8 point type with 12 point leading)215.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)315.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)415.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Presentation of Additional Information
B.01.460 (1) If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in English and a table in French or a table in English or French, that information shall be displayed
(a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figures 18.1(E) and (F) of Schedule L; and
(b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in Schedule L.
(2) If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in both English and French, that information shall be displayed
(a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figure 19.1(B) of Schedule L; and
(b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in Schedule L.
(3) Despite paragraph (1)(a), the use of indents illustrated in Figures 18.1(E) and (F) of Schedule L is not applicable if information referred to in column 1 of the table to section B.01.402 is set out in the linear format referred to in paragraph B.01.454(3)(c) or the simplified linear format referred to in paragraph B.01.455(3)(c).
Standard and Horizontal Formats — Children under Two Years of Age
B.01.461 (1) This section applies to a prepackaged product that is intended solely for children under two years of age unless section B.01.462, B.01.463 or B.01.464 applies to the product.
(2) Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in
(a) the bilingual standard format in accordance with Figure 22.5(B), 22.6(B) or 22.7(B) of Schedule L;
(b) the bilingual horizontal format in accordance with Figure 23.3(B) or 23.4(B) of Schedule L;
(c) the linear format in accordance with Figures 31.1(E) and (F) or 31.2(E) and (F) of Schedule L;
(d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or
(e) a manner described in section B.01.466.
(4) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included in that table.
TABLE
PART 1
STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use120.1(E) and (F)(8 point type with 12 point leading)220.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)320.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)420.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)520.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)620.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
NARROW STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use121.1(E) and (F)(8 point type with 12 point leading)221.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)321.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)421.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)PART 3
BILINGUAL STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use122.1(B)(8 point type with 12 point leading)222.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)322.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)422.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)PART 4
BILINGUAL HORIZONTAL FORMAT — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use123.1(B)The versions in Parts 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)223.2(B)The versions in Parts 1 to 3 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Simplified Formats — Children under Two Years of Age
B.01.462 (1) This section applies to a prepackaged product that is intended solely for children under two years of age if it satisfies the condition set out in subsection B.01.403(5) and its nutrition facts table includes only the information referred to in paragraphs B.01.403(5)(a) to (k).
(2) Subject to subsection (3), the nutrition facts table of the prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table containing only the information referred to in paragraphs B.01.403(5)(a) to (k) in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in
(a) the bilingual simplified standard format in accordance with Figure 25.5(B) or 25.6(B) of Schedule L;
(b) the bilingual simplified horizontal format in accordance with Figure 26.3(B) or 26.4(B) of Schedule L;
(c) the simplified linear format in accordance with Figures 32.1(E) and (F) or 32.2(E) and (F) of Schedule L;
(d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table; or
(e) a manner described in section B.01.466.
TABLE
PART 1
SIMPLIFIED STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use124.1(E) and (F)(8 point type with 12 point leading)224.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)324.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)424.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)524.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)624.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
BILINGUAL SIMPLIFIED STANDARD FORMAT — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use125.1(B)(8 point type with 12 point leading)225.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)325.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)425.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)PART 3
BILINGUAL SIMPLIFIED HORIZONTAL FORMAT — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use126.1(B)The versions in Parts 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)226.2(B)The versions in Parts 1 and 2 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Aggregate Format — Different Kinds of Foods — Children under Two Years of Age
B.01.463 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product that is intended solely for children under two years of age includes separate information for each food or ingredient as provided in subsection B.01.406(2), paragraph B.01.406(3)(a) or subsection B.01.406(4), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out
(a) in the case of a product described in subsection B.01.406(2) or (4), in
(i) the bilingual aggregate format in accordance with Figure 28.5(B) or 28.6(B) of Schedule L, or
(ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or
(b) in the case of a product described in paragraph B.01.406(3)(a), in
(i) the bilingual aggregate format in accordance with Figure 28.5(B) or 28.6(B) of Schedule L,
(ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or
(iii) a manner described in section B.01.466.
(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each food or ingredient for which separate information is set out in the table.
TABLE
PART 1
AGGREGATE FORMAT — DIFFERENT KINDS OF FOODS — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use127.1(E) and (F)(8 point type with 12 point leading)227.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)327.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)427.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)527.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)627.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
BILINGUAL AGGREGATE FORMAT — DIFFERENT KINDS OF FOODS — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use128.1(B)(8 point type with 12 point leading)228.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)328.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)428.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Aggregate Format — Different Amounts of Food — Children under Two Years of Age
B.01.464 (1) Subject to subsection (2), if the nutrition facts table of a prepackaged product that is intended solely for children under two years of age includes separate information for different amounts of the food as provided in subsection B.01.406(8), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.
(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out in
(a) the bilingual aggregate format in accordance with Figure 30.5(B) or 30.6(B) of Schedule L; or
(b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table.
(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each amount of the food for which separate information is set out in the table.
TABLE
PART 1
AGGREGATE FORMAT — DIFFERENT AMOUNTS OF FOOD — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use129.1(E) and (F)(8 point type with 12 point leading)229.2(E) and (F)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)329.3(E) and (F)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)429.4(E) and (F)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 10 point leading)529.5(E) and (F)The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)629.6(E) and (F)The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 9 point leading)PART 2
BILINGUAL AGGREGATE FORMAT — DIFFERENT AMOUNTS OF FOOD — CHILDREN UNDER TWO YEARS OF AGE
ItemColumn 1Column 2Figure in Schedule L (Version)Condition of use130.1(B)(8 point type with 12 point leading)230.2(B)The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point type with 11 point leading)330.3(B)The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(7 point condensed type with 11 point leading)430.4(B)The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.(6 point condensed type with 10 point leading)Presentation of Additional Information — Children under Two Years of Age
B.01.465 (1) This section applies to a prepackaged product that is intended solely for children under two years of age.
(2) If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in English and a table in French or a table in English or French, that information shall be displayed
(a) in accordance with the order of presentation and the use of indents illustrated in Figures 33.1(E) and (F) of Schedule L; and
(b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in Schedule L.
(3) If information referred to in column 1 of the table to section B.01.402 is included in a nutrition facts table that is set out in a version consisting of a table in both English and French, that information shall be displayed
(a) in accordance with the order of presentation and the use of indents illustrated in Figure 34.1(B) of Schedule L; and
(b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in Schedule L.
(4) Despite paragraph (2)(a), the use of indents illustrated in Figures 33.1(E) and (F) of Schedule L is not applicable if information referred to in column 1 of the table to section B.01.402 is set out in the linear format referred to in paragraph B.01.461(3)(c) or the simplified linear format referred to in paragraph B.01.462(3)(c).
Alternative Methods of Presentation
B.01.466 (1) Despite section A.01.016, the nutrition facts table of a prepackaged product that meets the condition specified in subsection B.01.454(3) or B.01.455(3), paragraph B.01.457(2)(b), subsection B.01.461(3) or B.01.462(3) or paragraph B.01.463(2)(b) may be set out on
(a) a tag attached to the package;
(b) a package insert;
(c) the inner side of a label;
(d) a fold-out label; or
(e) an outer sleeve, overwrap or collar.
(2) If the nutrition facts table is set out in a manner described in paragraph (1)(b) or (c), the outer side of the label of the package shall indicate in a type size of not less than 8 points where the nutrition facts table is located.
(3) If the nutrition facts table is set out in a manner described in subsection (1), it shall be set out
(a) in the case of a product described in subsection B.01.454(3), in a version that is described in paragraph B.01.454(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.454;
(b) in the case of a product described in subsection B.01.455(3), in a version that is described in paragraph B.01.455(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.455;
(c) in the case of a product described in paragraph B.01.457(2)(b), in a version that is described in subparagraph B.01.457(2)(b)(i) or that is listed in column 1 of the table to section B.01.457;
(d) in the case of a product described in subsection B.01.461(3), in a version that is described in paragraph B.01.461(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.461;
(e) in the case of a product described in subsection B.01.462(3), in a version that is described in paragraph B.01.462(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.01.462; and
(f) in the case of a product described in paragraph B.01.463(2)(b), in a version that is described in subparagraph B.01.463(2)(b)(i) or that is listed in column 1 of the table to section B.01.463.
Small Packages
B.01.467 (1) Despite section A.01.016 and subject to subsection (2), if the available display surface of a prepackaged product is less than 100 cm2, the label of the product need not carry a nutrition facts table if the outer side of the label contains an indication of how a purchaser or consumer may obtain the nutrition information that would otherwise be required to be set out in a nutrition facts table on the label of the product.
(2) Subsection (1) does not apply to a prepackaged product that is
(a) described in paragraph B.01.401(3)(a), (b), (c) or (e); or
(b) contained in a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase.
(3) An indication referred to in subsection (1)
(a) shall be set out in a type size of not less than 8 points;
(b) shall include a postal address or a toll-free telephone number; and
(c) shall be
(i) in English and French, or
(ii) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the product may be shown in that language only and is shown on the label in that language.
(4) The manufacturer of the prepackaged product shall provide the information referred to in subsection (1) to a purchaser or consumer on request
(a) without charge;
(b) in the following manner, namely,
(i) in the official language in which the information is requested or, if specified by the purchaser or consumer, in both official languages, or
(ii) in one of the official languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the product may be shown in that language only and is shown on the label in that language; and
(c) in the form of a nutrition facts table that is set out
(i) in a format, other than a horizontal format, that is specified in any of sections B.01.454 to B.01.459 or B.01.461 to B.01.464 and that would otherwise be carried on the label of the product in accordance with these Regulations, and
(ii) in a version of that format that is listed in column 1 of item 1 of any Part of the table to the applicable section referred to in subparagraph (i).
(5) In this section, official languages means the English language and the French language.
[B.01.468 to B.01.499 reserved]
Nutrient Content Claims
Interpretation
B.01.500 (1) The following definitions apply in this section and in the table following section B.01.513.
combination foods
combination foods means the category of food to which belong foods that contain as ingredients foods from more than one food group, or foods from one or more food groups mixed with foods from the category of other foods, such as pizza or lasagna. (aliments composés)
food group
food group means one of the following categories of foods:
(a) milk products, and milk product alternatives such as fortified plant-based beverages;
(b) meat, poultry and fish, and alternatives such as legumes, eggs, tofu or peanut butter;
(c) bread and grain products; or
(d) vegetables and fruit. (groupe alimentaire)
other foods
other foods means the category of food to which belong foods that are not part of any food group, including
(a) foods that are mostly fats, such as butter, margarine, oil or lard;
(b) foods that are mostly sugars, such as jam, honey, syrup or confectionery;
(c) snack foods, such as potato chips or pretzels;
(d) beverages, such as water, tea, coffee or soft drinks; and
(e) herbs, spices and condiments, such as pickles, mustard or ketchup. (autres aliments)
reference food of the same food group
reference food of the same food group means a food that can be substituted in the diet for the food to which it is compared and that belongs to
(a) the same food group as the food to which it is compared, such as cheese as a reference food for milk, or chicken as a reference food for tofu;
(b) the category of other foods, if the food to which it is compared also belongs to that category, such as pretzels as a reference food for potato chips; or
(c) the category of combination foods, if the food to which it is compared also belongs to that category, such as pizza as a reference food for lasagna. (aliment de référence du même groupe alimentaire)
similar reference food
similar reference food means a food of the same type as the food to which it is compared and that has not been processed, formulated, reformulated or otherwise modified in a manner that increases or decreases the energy value or the amount of a nutrient that is the subject of the comparison, such as whole milk as a similar reference food for partly skimmed milk or regular chocolate chip cookies as a similar reference food for fat-reduced chocolate chip cookies. (aliment de référence similaire)
(2) The similar reference food referred to in column 3 of item 45 of the table following section B.01.513, with respect to the subject “light in energy or fat” set out in column 1, shall have a nutrient value that is representative of foods of that type that have not been processed, formulated, reformulated or otherwise modified in a manner that increases the energy value or the amount of fat.
Languages
B.01.501 The representations provided for in sections B.01.503 to B.01.513 that appear on the label of a food shall be
(a) in English and French; or
(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.
Statements or Claims
B.01.502 (1) No person shall, on the label of or in any advertisement for a food, make a representation, express or implied, that characterizes the energy value of the food or the amount of a nutrient contained in the food.
(2) Subsection (1) does not apply to
(a) a representation otherwise provided for in these Regulations;
(b) a representation provided for by section 35 of the Processed Products Regulations;
(c) a representation provided for by subsection 94(4) of the Meat Inspection Regulations, 1990;
(d) a representation that characterizes the amount of lactose in a food;
(e) a representation that characterizes the addition of salt to a food, other than any statement or claim set out in column 4 of the table following section B.01.513;
(f) a representation that characterizes the addition of sugars to a food, other than any statement or claim set out in column 4 of the table following section B.01.513;
(g) a representation that characterizes the amount of starch in a food, if the food is intended solely for children under two years of age;
(h) the representations “defatted (naming the food)”, “demineralized (naming the food)” and “high (naming the monosaccharide or disaccharide) (naming the syrup)”;
(i) a representation that characterizes the amount of a fatty acid in a vegetable oil and forms part of its common name;
(j) a representation that characterizes the amount of alcohol in beverages that contain more than 0.5% alcohol;
(k) the representation “light salted” with respect to fish; or
(l) the English representation “lean” with respect to a prepackaged meal represented for use in a weight reduction diet or a weight maintenance diet.
B.01.503 (1) A person may, on the label of or in any advertisement for a food, make a statement or claim set out in column 4 of the table following section B.01.513, with respect to a subject set out in column 1, if
(a) the food meets the applicable conditions set out in column 2;
(b) the label or advertisement meets the conditions, if any, set out in column 3, in accordance with sections B.01.504 to B.01.506; and
(c) in the case of a food that is not a prepackaged product, or a prepackaged product for which an advertisement is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement includes, per serving of stated size, and in accordance with section B.01.505 or B.01.506 if applicable,
(i) the declaration of the energy value, if the energy value is the subject of the statement or claim, or
(ii) the amount of the nutrient, if a nutrient is the subject of the statement or claim.
(2) Despite subsection (1), no person shall, on the label of or in any advertisement for a food that is intended solely for children under two years of age, make a statement or claim set out in column 4 of the table following section B.01.513, unless it is a statement or claim respecting one of the following subjects set out in column 1:
(a) “source of protein”, set out in item 8;
(b) “excellent source of protein”, set out in item 9;
(c) “more protein”, set out in item 10;
(d) “no added sodium or salt”, set out in item 35; or
(e) “no added sugars”, set out in item 40.
(3) If a statement or claim set out in column 4 of the table following section B.01.513 is made on the label of or in any advertisement for a food, all the words, numbers, signs or symbols that constitute the statement or claim shall be of the same size and prominence.
(4) In the English version of the statements or claims, the word “fibre” may be spelled as “fiber”.
B.01.504 If a statement or claim set out in column 4 of the table following section B.01.513 is made on the label of a food, the information required under the conditions set out in column 3 shall be
(a) adjacent to, without any intervening printed, written or graphic material,
(i) the statement or claim, if the statement or claim is made only once, or
(ii) the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once; and
(b) shown in letters of at least the same size and prominence as
(i) those of the statement or claim, if the statement or claim is made only once, or
(ii) those of the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once.
B.01.505 If a statement or claim set out in column 4 of the table following section B.01.513 is made in an advertisement for a food, other than a radio or television advertisement, the information required under the conditions set out in column 3 and, if applicable, the information required by paragraph B.01.503(1)(c), shall be
(a) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and
(b) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.
B.01.506 (1) If a statement or claim set out in column 4 of the table following section B.01.513 is made in a radio or television advertisement, the information required under the conditions set out in column 3 and, if applicable, the information required by paragraph B.01.503(1)(c), shall be provided in the advertisement, except for the information required under the condition set out in paragraph (a) of column 3, in respect of the following subjects set out in column 1, which may be on the label:
(a) “reduced in energy”, set out in item 3;
(b) “reduced in fat”, set out in item 13;
(c) “reduced in saturated fatty acids”, set out in item 20;
(d) “reduced in trans fatty acids”, set out in item 23;
(e) “reduced in cholesterol”, set out in item 29;
(f) “reduced in sodium or salt”, set out in item 33;
(g) “lightly salted”, set out in item 36;
(h) “reduced in sugars”, set out in item 38; and
(i) “light in energy or fat”, set out in item 45.
(2) Despite subsection (1), if the statement or claim is made in a radio or television advertisement that is not made or placed by or on the direction of the manufacturer of the food, the information required under the condition set out in paragraph (a) of column 3 of the table following section B.01.513, in respect of the subjects set out in paragraphs (1)(a) to (i), shall be provided in the advertisement.
(3) If the information required under the conditions set out in column 3 of the table following section B.01.513 and the information required by paragraph B.01.503(1)(c) is provided in a radio advertisement or in the audio portion of a television advertisement, that information shall immediately precede or follow the statement or claim.
(4) In the case of a television advertisement, the information required under the conditions set out in column 3 of the table following section B.01.513 and, if applicable, the information required by paragraph B.01.503(1)(c), shall be communicated
(a) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions; or
(b) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.
(5) If the information required under the conditions set out in column 3 of the table following section B.01.513 and the information required by paragraph B.01.503(1)(c) is communicated in the visual mode of a television advertisement, it shall
(a) appear concurrently with and for at least the same amount of time as the statement or claim;
(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and
(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.
B.01.507 A person may, on the label of or in any advertisement for a food, make a representation, express or implied, that the food is for use in an energy-reduced diet, if a statement or claim set out in column 4 of the table following section B.01.513, in respect of any of the following subjects set out in column 1, is made on the label of or in the advertisement for the food, in accordance with section B.01.503:
(a) “free of energy”, set out in item 1;
(b) “low in energy”, set out in item 2;
(c) “reduced in energy”, set out in item 3;
(d) “lower in energy”, set out in item 4; or
(e) “free of sugars”, set out in item 37.
B.01.508 A person may, on the label of or in any advertisement for a food, make a representation, express or implied, that the food is for use in a sodium-restricted diet, if a statement or claim set out in column 4 of the table following section B.01.513, in respect of any of the following subjects set out in column 1, is made on the label of or in the advertisement for the food, in accordance with section B.01.503:
(a) “free of sodium or salt”, set out in item 31;
(b) “low in sodium or salt”, set out in item 32;
(c) “reduced in sodium or salt”, set out in item 33; or
(d) “lower in sodium or salt”, set out in item 34.
B.01.509 A person may, on the label of or in any advertisement for a food, make the statement or claim that the food is “unsweetened” if the food meets the conditions set out in column 2 of item 40 of the table following section B.01.513 for the subject “no added sugars” set out in column 1 and the food does not contain a sweetener set out in column I of Table IX to section B.16.100.
B.01.510 A statement or claim set out in column 4 of the table following section B.01.513, respecting the following subjects set out in column 1, that is made on the label of or in an advertisement for a breakfast cereal with milk, shall be accompanied by an indication that it refers to 30 g of the breakfast cereal combined with 125 mL of milk:
(a) “source of protein”, set out in item 8;
(b) “excellent source of protein”, set out in item 9; and
(c) “more protein”, set out in item 10.
B.01.511 (1) For greater certainty and subject to subsections (2) to (4), a statement or claim set out in column 4 of the table following section B.01.513 that is made on the label of or in any advertisement for a food may be preceded or followed by other words, numbers, signs or symbols, but none of those shall be interposed between the words, numbers, signs or symbols of the statement or claim.
(2) The words “very”, “ultra” and “extra”, and all other words, numbers, signs or symbols that modify the nature of a statement or claim, shall not precede or follow the statement or claim.
(3) A statement or claim that is made on the label of or in any advertisement for a food that has not been processed, formulated, reformulated or otherwise modified to meet the conditions set out in column 2 of the table following section B.01.513 shall not be accompanied by the brand name of the food.
(4) Any words, numbers, signs or symbols preceding or following the statement or claim referred to in subsection (3) shall accompany the statement or claim in such a manner that the statement or claim characterizes all foods of that type, and not only the specific food.
B.01.512 If a food meets the conditions set out in column 2 of the table following section B.01.513 for more than one of the subjects set out in column 1, it is not necessary to repeat the common element of the statements or claims set out in column 4 that are used on the label of or in the advertisement for the food, and the remaining elements may be joined by means of a conjunction or punctuation, as appropriate.
Sensory Characteristic
B.01.513 (1) No person shall, on the label of or in any advertisement for a food, make the statement or claim “light” or “léger” — including any phonetic rendering of that statement or claim — respecting a sensory characteristic of the food unless the following conditions are met:
(a) if the statement or claim “light” or “léger” is made on the label of a food, the sensory characteristic shall be
(i) adjacent to, without any intervening printed, written or graphic material,
(A) the statement or claim, if the statement or claim is made only once, or
(B) the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once, and
(ii) shown in letters of at least the same size and prominence as
(A) those of the statement or claim, if the statement or claim is made only once, or
(B) those of the most prominent statement or claim on the principal display panel or, if none appears there, the most prominent statement or claim elsewhere on the label, if the statement or claim is made more than once;
(b) if the statement or claim “light” or “léger” is made in an advertisement for a food, other than a radio or television advertisement, the sensory characteristic shall be
(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and
(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;
(c) if the statement or claim “light” or “léger” is made in a radio advertisement or in the audio portion of a television advertisement, the sensory characteristic shall immediately precede or follow the statement or claim; and
(d) if the statement or claim “light” or “léger” is made in the visual portion of a television advertisement, the sensory characteristic shall
(i) appear concurrently with and for the same amount of time as the statement or claim,
(ii) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and
(iii) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.
(2) Subsection (1) does not apply to
(a) the English statement or claim “light” when used in accordance with subsection 12(1) of the Maple Products Regulations; or
(b) the statement or claim “light” or “léger” when used with respect to rum.
TABLE
Column 1Column 2Column 3Column 4ItemSubjectConditions — FoodConditions — Label or AdvertisementStatement or Claim 1Free of energyThe food provides less than 5 Calories or 21 kilojoules per reference amount and serving of stated size.“energy-free”, “free of energy”, “no energy”, “0 energy”, “zero energy”, “without energy”, “contains no energy”, “Calorie-free”, “free of Calories”, “no Calories”, “0 Calories”, “zero Calories”, “without Calories” or “contains no Calories”2Low in energyThe food provides
(a) 40 Calories or 167 kilojoules or less per reference amount and serving of stated size and, if the reference amount is 30 g or 30 mL or less, per 50 g; or
(b) 120 Calories or 500 kilojoules or less per 100 g, if the food is a prepackaged meal.
(1) The food is processed, formulated, reformulated or otherwise modified so that it provides at least 25% less energy
(a) per reference amount of the food, than the reference amount of the similar reference food; or
(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.
(2) The similar reference food does not meet the conditions set out in column 2 of item 2 for the subject “low in energy” set out in column 1.
(a) the similar reference food;
(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and
(c) the difference in energy value compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in Calories.
(1) The food provides at least 25% less energy
(a) per reference amount of the food, than the reference amount of the reference food of the same food group; or
(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.
(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 2 for the subject “low in energy” set out in column 1.
(a) the reference food of the same food group;
(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and
(c) the difference in energy value compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in Calories.
The food provides at least 25% more energy, totalling at least 100 more Calories or 420 more kilojoules
(a) per reference amount of the food, than the reference amount of the reference food of the same food group or the similar reference food; or
(b) per 100 g, than 100 g of the reference food of the same food group or the similar reference food, if the food is a prepackaged meal.
The following are identified:
(a) the reference food of the same food group or the similar reference food;
(b) the amounts of the food and the reference food of the same food group or the similar reference food being compared, if those amounts are not equal; and
(c) the difference in energy value compared to the reference food of the same food group or the similar reference food, per serving of stated size, expressed as a percentage or fraction or in Calories.
The food has a protein rating of 20 or more, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981,
(a) per reasonable daily intake; or
(b) per 30 g combined with 125 mL of milk, if the food is a breakfast cereal.
The food has a protein rating of 40 or more, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981,
(a) per reasonable daily intake; or
(b) per 30 g combined with 125 mL of milk, if the food is a breakfast cereal.
The food
(a) has a protein rating of 20 or more, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981,
(i) per reasonable daily intake, or
(ii) per 30 g combined with 125 mL of milk, if the food is a breakfast cereal; and
(b) contains at least 25% more protein, totalling at least 7 g more, per reasonable daily intake than the reference food of the same food group or the similar reference food.
The following are identified:
(a) the reference food of the same food group or the similar reference food;
(b) the amounts of the food and the reference food of the same food group or the similar reference food being compared, if those amounts are not equal; and
(c) the difference in protein compared to the reference food of the same food group or the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.
The food contains
(a) less than 0.5 g of fat per reference amount and serving of stated size; or
(b) less than 0.5 g of fat per serving of stated size, if the food is a prepackaged meal.
The food contains
(a) 3 g or less of fat per reference amount and serving of stated size and, if the reference amount is 30 g or 30 mL or less, per 50 g; or
(b) 3 g or less of fat per 100 g with 30% or less of the energy from fat, if the food is a prepackaged meal.
(1) The food is processed, formulated, reformulated or otherwise modified so that it contains at least 25% less fat
(a) per reference amount of the food, than the reference amount of the similar reference food; or
(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.
(2) The similar reference food does not meet the conditions set out in column 2 of item 12 for the subject “low in fat” set out in column 1.
The following are identified:
(a) the similar reference food;
(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and
(c) the difference in fat compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.
(1) The food contains at least 25% less fat
(a) per reference amount of the food, than the reference amount of the reference food of the same food group; or
(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.
(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 12 for the subject “low in fat” set out in column 1.
The following are identified:
(a) the reference food of the same food group;
(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and
(c) the difference in fat compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in grams.
The food
(a) contains less than 0.5 g of fat per 100 g;
(b) contains no added fat; and
(c) meets the conditions set out in column 2 of item 11 for the subject “free of fat” set out in column 1.
(1) The food contains no added fats or oils set out in Division 9, or added butter or ghee, or ingredients that contain added fats or oils, or butter or ghee.
(2) The similar reference food contains added fats or oils set out in Division 9, or added butter or ghee.
The food contains
(a) less than 0.2 g saturated fatty acids and less than 0.2 g trans fatty acids per reference amount and serving of stated size; or
(b) less than 0.2 g saturated fatty acids and less than 0.2 g trans fatty acids per serving of stated size, if the food is a prepackaged meal.
(1) The food contains 2 g or less of saturated fatty acids and trans fatty acids combined
(a) per reference amount and serving of stated size; or
(b) per 100 g, if the food is a prepackaged meal.
(2) The food provides 15% or less energy from the sum of saturated fatty acids and trans fatty acids.
(1) The food is processed, formulated, reformulated or otherwise modified, without increasing the content of trans fatty acids, so that it contains at least 25% less saturated fatty acids
(a) per reference amount of the food, than the reference amount of the similar reference food; or
(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.
(2) The similar reference food does not meet the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.
The following are identified:
(a) the similar reference food;
(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and
(c) the difference in saturated fatty acids compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.
(1) The food contains at least 25% less saturated fatty acids and the content of trans fatty acids is not higher
(a) per reference amount of the food, than the reference amount of the reference food of the same food group; or
(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.
(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.
The following are identified:
(a) the reference food of the same food group;
(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and
(c) the difference in saturated fatty acids compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in grams.
The food
(a) contains less than 0.2 g of trans fatty acids
(i) per reference amount and serving of stated size, or
(ii) per serving of stated size, if the food is a prepackaged meal; and
(b) meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.
(1) The food is processed, formulated, reformulated or otherwise modified, without increasing the content of saturated fatty acids, so that it contains at least 25% less trans fatty acids
(a) per reference amount of the food, than the reference amount of the similar reference food; or
(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.
(2) The similar reference food does not meet the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.
The following are identified:
(a) the similar reference food;
(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and
(c) the difference in trans fatty acids compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.
(1) The food contains at least 25% less trans fatty acids and the content of saturated fatty acids is not higher
(a) per reference amount of the food, than the reference amount of the reference food of the same food group; or
(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.
(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.
The following are identified:
(a) the reference food of the same food group;
(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and
(c) the difference in trans fatty acids compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in grams.
The food contains
(a) 0.3 g or more of omega-3 polyunsaturated fatty acids per reference amount and serving of stated size; or
(b) 0.3 g or more of omega-3 polyunsaturated fatty acids per 100 g, if the food is a prepackaged meal.
The food contains
(a) 2 g or more of omega-6 polyunsaturated fatty acids per reference amount and serving of stated size; or
(b) 2 g or more of omega-6 polyunsaturated fatty acids per 100 g, if the food is a prepackaged meal.
The food
(a) contains less than 2 mg of cholesterol
(i) per reference amount and serving of stated size, or
(ii) per serving of stated size, if the food is a prepackaged meal; and
(b) meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.
The food
(a) contains 20 mg or less of cholesterol per
(i) reference amount and serving of stated size and, if the reference amount is 30 g or 30 mL or less, per 50 g, or
(ii) per 100 g, if the food is a prepackaged meal; and
(b) meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.
(1) The food is processed, formulated, reformulated or otherwise modified so that it contains at least 25% less cholesterol
(a) per reference amount of the food, than the reference amount of the similar reference food; or
(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.
(2) The similar reference food does not meet the conditions set out in column 2 of item 28 for the subject “low in cholesterol” set out in column 1.
(3) The food meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.
The following are identified:
(a) the similar reference food;
(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and
(c) the difference in cholesterol compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in milligrams.
(1) The food contains at least 25% less cholesterol
(a) per reference amount of the food, than the reference amount of the reference food of the same food group; or
(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.
(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 28 for the subject “low in cholesterol” set out in column 1.
(3) The food meets the conditions set out in column 2 of item 19 for the subject “low in saturated fatty acids” set out in column 1.
The following are identified:
(a) the reference food of the same food group;
(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and
(c) the difference in cholesterol compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in milligrams.
The food contains
(a) less than 5 mg of sodium per reference amount and serving of stated size; or
(b) less than 5 mg of sodium per serving of stated size, if the food is a prepackaged meal.
The food contains
(a) 140 mg or less of sodium per reference amount and serving of stated size and, if the reference amount is 30 g or 30 mL or less, per 50 g; or
(b) 140 mg or less of sodium per 100 g, if the food is a prepackaged meal.
(1) The food is processed, formulated, reformulated or otherwise modified so that it contains at least 25% less sodium
(a) per reference amount of the food, than the reference amount of the similar reference food; or
(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.
(2) The similar reference food does not meet the conditions set out in column 2 of item 32 for the subject “low in sodium or salt” set out in column 1.
The following are identified:
(a) the similar reference food;
(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and
(c) the difference in sodium content compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in milligrams.
(1) The food contains at least 25% less sodium
(a) per reference amount of the food, than the reference amount of the reference food of the same food group; or
(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.
(2) The reference food of the same food group does not meet the conditions set out in column 2 of item 32 for the subject “low in sodium or salt” set out in column 1.
The following are identified:
(a) the reference food of the same food group;
(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and
(c) the difference in sodium content compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in milligrams.
(1) The food contains no added salt, other sodium salts or ingredients that contain sodium that functionally substitute for added salt.
(2) The similar reference food does not meet the conditions set out in column 2 of item 32 for the subject “low in sodium or salt” set out in column 1 and contains added salt or other sodium salts.
(1) The food contains at least 50% less added sodium than the sodium added to the similar reference food.
(2) The similar reference food does not meet the conditions set out in column 2 of item 32 for the subject “low in sodium or salt” set out in column 1.
The following are identified:
(a) the similar reference food;
(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and
(c) the difference in sodium content compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in milligrams.
The food
(a) contains less than 0.5 g of sugars per reference amount and serving of stated size; and
(b) with the exception of chewing gum, meets the conditions set out in column 2 of item 1 for the subject “free of energy” set out in column 1.
The food is processed, formulated, reformulated or otherwise modified so that it contains at least 25% less sugars, totalling at least 5 g less,
(a) per reference amount of the food, than the reference amount of the similar reference food; or
(b) per 100 g, than 100 g of the similar reference food, if the food is a prepackaged meal.
The following are identified:
(a) the similar reference food;
(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and
(c) the difference in sugars compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.
The food contains at least 25% less sugars, totalling at least 5 g less,
(a) per reference amount of the food, than the reference amount of the reference food of the same food group; or
(b) per 100 g, than 100 g of the reference food of the same food group, if the food is a prepackaged meal.
The following are identified:
(a) the reference food of the same food group;
(b) the amounts of the food and the reference food of the same food group being compared, if those amounts are not equal; and
(c) the difference in sugars compared to the reference food of the same food group, per serving of stated size, expressed as a percentage or fraction or in grams.
(1) The food contains no added sugars, no ingredients containing added sugars or ingredients that contain sugars that functionally substitute for added sugars.
(2) The sugars content is not increased through some other means except if the functional effect is not to increase the sugars content of the food.
(3) The similar reference food contains added sugars.
(1) The food contains 2 g or more
(a) of fibre per reference amount and serving of stated size, if no fibre or fibre source is identified in the statement or claim; or
(b) of each identified fibre or fibre from an identified fibre source per reference amount and serving of stated size, if a fibre or fibre source is identified in the statement or claim.
(2) The food contains at least one ingredient that meets one of the conditions set out in subsection (1), if the food is a prepackaged meal.
(1) The food contains 4 g or more
(a) of fibre per reference amount and serving of stated size, if no fibre or fibre source is identified in the statement or claim; or
(b) of each identified fibre or fibre from an identified fibre source per reference amount and serving of stated size, if a fibre or fibre source is identified in the statement or claim.
(2) The food contains at least one ingredient that meets one of the conditions set out in subsection (1), if the food is a prepackaged meal.
(1) The food contains 6 g or more
(a) of fibre per reference amount and serving of stated size, if no fibre or fibre source is identified in the statement or claim; or
(b) of each identified fibre or fibre from an identified fibre source per reference amount and serving of stated size, if a fibre or fibre source is identified in the statement or claim.
(2) The food contains at least one ingredient that meets one of the conditions set out in subsection (1), if the food is a prepackaged meal.
(1) The food contains at least 25% more fibre, totalling at least 1 g more, if no fibre or fibre source is identified in the statement or claim, or at least 25% more of an identified fibre or fibre from an identified fibre source, totalling at least 1 g more, if a fibre or fibre source is identified in the statement or claim
(a) per reference amount of the food, than the reference amount of the reference food of the same food group or the similar reference food; or
(b) per 100 g, than 100 g of the reference food of the same food group or the similar reference food, if the food is a prepackaged meal.
(2) The food contains
(a) at least 2 g of fibre per reference amount and serving of stated size if no fibre or fibre source is identified in the statement or claim, or at least 2 g of identified fibre or fibre from an identified fibre source per reference amount and serving of stated size if a fibre or fibre source is identified in the statement or claim; or
(b) at least one ingredient that meets the conditions set out in column 2 of item 41 for the subject “source of fibre” set out in column 1, if the food is a prepackaged meal.
The following are identified:
(a) the reference food of the same food group or the similar reference food;
(b) the amounts of the food and the reference food of the same food group or the similar reference food being compared, if those amounts are not equal; and
(c) the difference in fibre compared to the reference food of the same food group or the similar reference food, per serving of stated size, expressed as a percentage or fraction or in grams.
The food meets the conditions set out in column 2
(a) of item 3 for the subject “reduced in energy” set out in column 1; or
(b) of item 13 for the subject “reduced in fat” set out in column 1.
The following are identified:
(a) the similar reference food;
(b) the amounts of the food and the similar reference food being compared, if those amounts are not equal; and
(c) the difference in energy or fat value compared to the similar reference food, per serving of stated size, expressed as a percentage or fraction or in Calories or grams.
The food
(a) is meat or poultry that has not been ground, a marine or fresh water animal or a product of any of these; and
(b) contains 10% or less fat.
The food
(a) is meat or poultry that has not been ground, a marine or fresh water animal or a product of any of these; and
(b) contains 7.5% or less fat.
[B.01.514 to B.01.599 reserved]
Health Claims
Languages
B.01.600 A statement or claim set out in column 1 of the table following section B.01.603 that appears on the label of a food shall be
(a) in English and French; or
(b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.
Statements or Claims
B.01.601 (1) A food with a label or advertisement that carries a statement or claim set out in column 1 of the table following section B.01.603 is exempt from the provisions of the Act and its Regulations with respect to drugs, and from subsections 3(1) and (2) of the Act, if
(a) the food meets the applicable conditions set out in column 2;
(b) the label of or the advertisement for the food meets the applicable conditions set out in column 3; and
(c) the food is not
(i) intended solely for children under two years of age, or
(ii) a food represented for use in a very low energy diet.
(2) Subsection (1) does not apply to a food that comes within the definition of drug as defined in section 2 of the Act for a reason other than the fact that its label or advertisement carries a statement or claim referred to in that subsection.
(3) Subsection (1) applies even if the word “graisses” in the French version of the statement or claim is replaced by the word “lipides”.
B.01.602 (1) The information required under the conditions set out in column 3 of the table following section B.01.603 that appears in an advertisement for a food that is not a prepackaged product, or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, shall,
(a) in the case of an advertisement, other than a radio or television advertisement, be
(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim set out in column 1, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and
(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;
(b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim set out in column 1; or
(c) in the case of a television advertisement, be communicated
(i) in the audio mode, if the statement or claim set out in column 1 is made only in the audio portion of the advertisement or in both the audio and visual portions, or
(ii) in the audio or visual mode, if the statement or claim set out in column 1 is made only in the visual portion of the advertisement.
(2) The information that is communicated in the visual mode of a television advertisement in accordance with subparagraph (1)(c)(ii) shall
(a) appear concurrently with and for at least the same amount of time as the statement or claim;
(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and
(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.
B.01.603 For greater certainty, a statement or claim set out in column 1 of the table following this section that is made on the label of or in any advertisement for a food may be preceded or followed by other words, numbers, signs or symbols, but none of those shall be interposed between the words, numbers, signs or symbols of the statement or claim.
TABLE
Column 1Column 2Column 3ItemStatement or ClaimConditions — FoodConditions — Label or Advertisement1(1) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is sodium-free.”
(2) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is low in sodium.”
(3) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is a good source of potassium and is sodium-free.”
(4) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is a good source of potassium and is low in sodium.”
(5) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is high in potassium and is sodium-free.”
(6) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is high in potassium and is low in sodium.”
The food
(a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the table following section B.01.513 for the subject “low in energy” set out in column 1;
(b) contains at least 10% of the weighted recommended nutrient intake of a vitamin or a mineral nutrient
(i) per reference amount and per serving of stated size, or
(ii) per serving of stated size, if the food is a prepackaged meal;
(c) meets the conditions set out in column 2 of item 19 of the table following section B.01.513 for the subject “low in saturated fatty acids” set out in column 1;
(d) contains 0.5% or less alcohol;
(e) meets the conditions set out in column 2 of item 31 of the table following section B.01.513 for the subject “free of sodium or salt” set out in column 1, if the label of or advertisement for the food carries statement or claim (1), (3) or (5) set out in column 1 of this item;
(f) meets the conditions set out in column 2 of item 32 of the table following section B.01.513 for the subject “low in sodium or salt” set out in column 1, if the label of or advertisement for the food carries statement or claim (2), (4) or (6) set out in column 1 of this item; and
(1) If the statement or claim is made on the label of or in the advertisement for a prepackaged product, by or on the direction of the manufacturer of the product, the nutrition facts table shall include the amount of potassium, in accordance with subsection B.01.402(2).
(2) If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of sodium and potassium per serving of stated size, in accordance with section B.01.602 if applicable.
(g) contains 350 mg or more of potassium, if the label of or advertisement for the food carries statement or claim (3), (4), (5) or (6) set out in column 1 of this item,
(i) per reference amount and per serving of stated size, or
(ii) per serving of stated size, if the food is a prepackaged meal.
(1) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is a good source of calcium.”
(2) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is high in calcium.”
(3) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium.”
(4) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is very high in calcium.”
(5) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium and vitamin D.”
The food
(a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the table following section B.01.513 for the subject “low in energy” set out in column 1;
(b) contains no more phosphorus, excluding that provided by phytate, than calcium;
(c) contains 0.5% or less alcohol;
(d) contains, if the label of or advertisement for the food carries statement or claim (1) or (2) set out in column 1 of this item,
(i) 200 mg or more of calcium per reference amount and per serving of stated size, or
(ii) 300 mg or more of calcium per serving of stated size, if the food is a prepackaged meal;
(e) contains, if the label of or advertisement for the food carries statement or claim (3), (4), (5) or (6) set out in column 1 of this item,
(i) 275 mg or more of calcium per reference amount and per serving of stated size, or
(ii) 400 mg or more of calcium per serving of stated size, if the food is a prepackaged meal; and
(1) If the statement or claim is made on the label of or in the advertisement for a prepackaged product, by or on the direction of the manufacturer of the product, the nutrition facts table shall include the amount of vitamin D and phosphorus, in accordance with subsection B.01.402(2).
(2) If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of vitamin D, calcium and phosphorus per serving of stated size, in accordance with section B.01.602 if applicable.
(6) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is very high in calcium and vitamin D.”
(f) contains 1.25 µg or more of vitamin D, if the label of or advertisement for the food carries statement or claim (5) or (6) set out in column 1 of this item,
(i) per reference amount and per serving of stated size, or
(ii) per serving of stated size, if the food is a prepackaged meal.
(1) “A healthy diet low in saturated and trans fats may reduce the risk of heart disease. (Naming the food) is free of saturated and trans fats.”
(2) “A healthy diet low in saturated and trans fats may reduce the risk of heart disease. (Naming the food) is low in saturated and trans fats.”
The food
(a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the table following section B.01.513 for the subject “low in energy” set out in column 1;
(b) contains at least 10% of the weighted recommended nutrient intake of a vitamin or a mineral nutrient
(i) per reference amount and per serving of stated size, or
(ii) per serving of stated size, if the food is a prepackaged meal;
If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of saturated fatty acids and trans fatty acids per serving of stated size, in accordance with section B.01.602 if applicable.
(c) contains 100 mg or less of cholesterol per 100 g of food;
(d) contains 0.5% or less alcohol;
(e) if it is a fat or an oil, meets the conditions set out in
(i) column 2 of item 25 of the table following section B.01.513 for the subject “source of omega-3 polyunsaturated fatty acids” set out in column 1,
(ii) column 2 of item 26 of the table following section B.01.513 for the subject “source of omega-6 polyunsaturated fatty acids” set out in column 1, or
(iii) subparagraphs (i) and (ii);
(f) contains
(i) 480 mg or less of sodium per reference amount and per serving of stated size, and per 50 g if the reference amount is 30 g or 30 mL or less, or
(ii) 960 mg or less of sodium per serving of stated size, if the food is a prepackaged meal;
(g) meets the conditions set out in column 2 of item 18 of the table following section B.01.513 for the subject “free of saturated fatty acids” set out in column 1, if the label of or advertisement for the food carries statement or claim (1) set out in column 1 of this item; and
(h) meets the conditions set out in column 2 of item 19 of the table following section B.01.513 for the subject “low in saturated fatty acids” set out in column 1, if the label of or advertisement for the food carries statement or claim (2) set out in column 1 of this item.
“A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of some types of cancer.”
The food
(a) is one of the following vegetables, fruit, or juice, and may contain only sweetening agents, food additives as permitted by these Regulations, salt, herbs, spices, seasonings or water:
(i) a fresh, frozen, canned or dried vegetable,
(ii) a fresh, frozen, canned or dried fruit,
(iii) a vegetable or fruit juice, or
(iv) a combination of the foods set out in subparagraphs (i) to (iii);
(b) is not one of the following:
(i) potatoes, yams, cassava, plantain, corn, mushrooms, mature legumes and their juices,
(ii) vegetables or fruit used as condiments, garnishes or flavourings, including maraschino cherries, glacé fruit, candied fruit and onion flakes,
(iii) jams or jam-type spreads, marmalades, preserves and jellies,
(iv) olives, or
(v) powdered vegetables or fruit; and
(c) contains 0.5% or less alcohol.
(1) “Won’t cause cavities.”
(2) “Does not promote tooth decay.”
(3) “Does not promote dental caries.”
(4) “Non-cariogenic.”
The food is a chewing gum, hard candy or breath- freshening product that
(a) contains 0.25% or less starch, dextrins, mono-, di- and oligosaccharides or other fermentable carbohydrates combined; or
If the statement or claim is made on the label of or in the advertisement for a prepackaged product, by or on the direction of the manufacturer of the product, the nutrition facts table shall include the amount of sugar alcohols, if present, in accordance with subsection B.01.402(2).
(b) does not, if it contains more than 0.25% fermentable carbohydrates, lower plaque pH below 5.7 by bacterial fermentation during 30 minutes after consumption as measured by the indwelling plaque pH test, referred to in “Identification of Low Caries Risk Dietary Components” by T.N. Imfeld, Volume 11, Monographs in Oral Science, 1983.
DIVISION 2
Alcoholic Beverages
B.02.001 The foods referred to in this Division are included in the term alcoholic beverage.
B.02.002 In this Division,
absolute alcohol
absolute alcohol means alcohol of a strength of 100 per cent; (alcool absolu)
age
age means the period during which an alcoholic beverage is kept under such conditions of storage as may be necessary to develop its characteristic flavour and bouquet; (âge)
alcohol
alcohol means ethyl alcohol; (alcool)
flavouring
flavouring means, in respect of a spirit, any other spirit or wine, domestic or imported, added as a flavouring to that spirit as authorized under the Excise Act; (substance aromatique)
grain spirit
grain spirit means an alcoholic distillate, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzymes and fermented by the action of yeast or a mixture of yeast and other micro-organisms, and from which all or nearly all of the naturally occurring substances other than alcohol and water have been removed; (esprit de grain)
malt spirit
malt spirit means an alcoholic distillate, obtained by pot-still distillation from a mash of cereal grain or cereal grain products saccharified by the diastase of malt and fermented by the action of yeast or a mixture of yeast and other micro-organisms; (esprit de malt)
molasses spirit
molasses spirit means an alcoholic distillate, obtained from sugar-cane or sugar-cane products fermented by the action of yeast or a mixture of yeast and other micro-organisms, from which all or nearly all of the naturally occurring substances other than alcohol and water have been removed; (esprit de mélasse)
small wood
small wood means wood casks or barrels of not greater than 700 L capacity; (petit fût)
sweetening agent
sweetening agent means glucose-fructose, fructose syrup or any food for which a standard is provided in Division 18, or any combination thereof. (agent édulcorant)
B.02.003 Where an alcoholic beverage contains 1.1 per cent or more alcohol by volume, the percentage by volume of alcohol present in the alcoholic beverage shall be shown on the principal display panel followed by the words “alcohol by volume” or the abbreviation “alc./vol.”.
Whisky
B.02.010 [S]. Whisky or Whiskey, other than Malt Whisky, Scotch Whisky, Irish Whisky, Canadian Whisky, Canadian Rye Whisky, Rye Whisky, Highland Whisky, Bourbon Whisky and Tennessee Whisky,
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzymes and fermented by the action of yeast or a mixture of yeast and other micro-organisms; and
(b) may contain caramel and flavouring.
B.02.011 and B.02.012 [Repealed, SOR/93-145, s. 7]
B.02.013 [S]. Malt Whisky
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of a mash of malted grain fermented by the action of yeast or a mixture of yeast and other micro-organisms;
(b) shall possess the aroma, taste and character generally attributed to malt whisky; and
(c) may contain caramel and flavouring.
B.02.014 and B.02.015 [Repealed, SOR/93-145, s. 9]
B.02.016 [S]. Scotch Whisky shall be whisky distilled in Scotland as Scotch whisky for domestic consumption in accordance with the laws of the United Kingdom.
B.02.017 No person shall blend or modify in any manner any Scotch whisky that is imported in bulk for the purpose of bottling and sale in Canada as Scotch whisky except by
(a) blending with other Scotch whisky,
(b) the addition of distilled or otherwise purified water to adjust to a required strength, or
(c) the addition of caramel.
B.02.018 [S]. Irish Whisky shall be whisky distilled in Northern Ireland or in the Republic of Ireland as Irish whisky for domestic consumption in accordance with the laws of Northern Ireland or the Republic of Ireland.
B.02.019 No person shall blend or modify in any manner any Irish whisky that is imported in bulk for the purpose of bottling and sale in Canada as Irish whisky except by
(a) blending with other Irish whisky,
(b) the addition of distilled or otherwise purified water to adjust to a required strength, or
(c) the addition of caramel.
B.02.020 [S]. (1) Canadian Whisky, Canadian Rye Whisky or Rye Whisky
(a) shall
(i) be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzymes and fermented by the action of yeast or a mixture of yeast and other micro-organisms,
(ii) be aged in small wood for not less than three years,
(iii) possess the aroma, taste and character generally attributed to Canadian whisky,
(iv) be manufactured in accordance with the requirements of the Excise Act and the regulations made thereunder,
(v) be mashed, distilled and aged in Canada, and
(vi) contain not less than 40 per cent alcohol by volume; and
(b) may contain caramel and flavouring.
(2) Subject to subsection (3), no person shall make any claim with respect to the age of Canadian whisky, other than for the period during which the whisky has been held in small wood.
(3) Where Canadian whisky has been aged in small wood for a period of at least three years, any period not exceeding six months during which that whisky was held in other containers may be claimed as age.
B.02.021 [S]. Highland Whisky
(a) shall be a potable alcoholic beverage blended in Canada from
(i) not less than 25 per cent malt whisky calculated on an absolute alcohol basis, distilled in Canada or Scotland, and
(ii) whisky; and
(b) may, if it contains 51 per cent or more malt whisky distilled in Scotland, be labelled or advertised as containing malt whisky distilled in Scotland.
B.02.022 (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Bourbon Whisky, or in such a manner that it is likely to be mistaken for Bourbon whisky unless it is whisky manufactured in the United States as Bourbon whisky in accordance with the laws of the United States applicable in respect of Bourbon whisky for consumption in the United States.
(2) A person may modify Bourbon whisky that is imported for the purpose of bottling and sale in Canada as Bourbon whisky by the addition of distilled or otherwise purified water to adjust the Bourbon whisky to a required strength.
B.02.022.1 (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Tennessee Whisky, or in such a manner that it is likely to be mistaken for Tennessee whisky unless it is a straight Bourbon whisky produced in the State of Tennessee and manufactured in the United States as Tennessee whisky in accordance with the laws of the United States applicable in respect of Tennessee whisky for consumption in the United States.
(2) A person may modify Tennessee whisky that is imported for the purpose of bottling and sale in Canada as Tennessee whisky by the addition of distilled or otherwise purified water to adjust the Tennessee whisky to a required strength.
B.02.023 (1) Subject to sections B.02.022 and B.02.022.1, no person shall sell for consumption in Canada any whisky that has not been aged for a period of at least three years in small wood.
(2) Nothing in subsection (1) applies in respect of flavouring contained in whisky, but no person shall sell for consumption in Canada whisky containing any flavouring, other than wine, that has not been aged for a period of at least two years in small wood.
Rum
B.02.030 [S]. Rum
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from sugar-cane or sugar-cane products fermented by the action of yeast or a mixture of yeast and other micro-organisms; and
(b) may contain
(i) caramel,
(ii) fruit and other botanical substances, and
(iii) flavouring and flavouring preparations.
B.02.031 (1) No person shall sell for consumption in Canada any rum that has not been aged for a period of at least one year in small wood.
(2) Nothing in subsection (1) applies in respect of flavouring contained in rum, but no person shall sell for consumption in Canada rum containing any flavouring, other than wine, that has not been aged for a period of at least one year in small wood.
B.02.032 [Repealed, SOR/93-145, s. 14]
B.02.033 No person shall blend or modify in any manner any rum that is imported in bulk for the purpose of bottling and sale in Canada as imported rum except by
(a) blending with other imported rum,
(b) adding distilled or otherwise purified water to adjust the rum to the strength stated on the label applied to the container; or
(c) the addition of caramel.
B.02.034 (1) Notwithstanding section B.02.033, no person shall blend or modify in any manner any rum made from sugar cane products of a Commonwealth Caribbean country that has been distilled and fermented in a Commonwealth Caribbean country and imported in bulk from a Commonwealth Caribbean Country for bottling and sale in Canada as Caribbean rum except by
(a) blending with other rum of a Commonwealth Caribbean country;
(b) blending with Canadian rum in proportions that result in one to 1.5 per cent Canadian rum by volume in the final product;
(c) adding distilled or otherwise purified water to adjust the rum to the strength stated on the label applied to the container; or
(d) adding caramel.
(2) In this section, Commonwealth Caribbean country means Anguilla, Antigua and Barbuda, Barbados, the Bahamas, Belize, Bermuda, the British Virgin Islands, the Caymen Islands, Dominica, Grenada, Guyana, Jamaica, Montserrat, St. Christopher and Nevis, Saint Lucia, St. Vincent and the Grenadines, Trinidad and Tobago and the Turks and Caicos Islands.
Gin
B.02.040 [S]. Hollands, Hollands Gin, Geneva, Geneva Gin, Genever, Genever Gin or Dutch-type Gin
(a) shall be a potable alcoholic beverage obtained
(i) by the redistillation of malt spirit with or over juniper berries, or by a mixture of the products of more than one such redistillation,
(ii) by the redistillation of a combination of malt spirit and not more than four times its volume on an absolute alcohol basis of grain spirit with or over juniper berries, or by a mixture of the products of more than one such redistillation, or
(iii) by the blending of malt spirit, redistilled with or over juniper berries, with not more than four times its volume on an absolute alcohol basis of grain spirit or molasses spirit, or by a mixture of the products of more than one such blending;
(b) may contain
(i) other aromatic botanical substances, added during the redistillation process, and
(ii) caramel;
(c) shall not contain more than two per cent sweetening agent;
(d) may be labelled or advertised as being distilled, where subparagraph (a)(i) or (ii) is complied with; and
(e) shall be described on the principal display panel of its label and in any advertisements as blended gin, where subparagraph (a)(iii) is complied with.
B.02.041 [S]. Gin, other than Hollands, Hollands Gin, Geneva, Geneva Gin, Genever, Genever Gin or Dutch-type Gin,
(a) shall be a potable alcoholic beverage obtained
(i) by the redistillation of alcohol from food sources with or over juniper berries, or by a mixture of the products of more than one such redistillation, or
(ii) by the blending of alcohol from food sources, redistilled with or over juniper berries, with alcohol from food sources or by a mixture of the products of more than one such blending;
(b) may contain
(i) other aromatic botanical substances, added during the redistillation process,
(ii) a sweetening agent, and
(iii) a flavouring preparation for the purpose of maintaining a uniform flavour profile; and
(c) may be labelled or advertised as Dry Gin or London Dry Gin if sweetening agents have not been added.
B.02.042 [Repealed, SOR/93-145, s. 15]
B.02.043 No person shall make any claim for age for gin but gin that has been held in suitable containers may bear a label declaration to that effect.
Brandy
B.02.050 [S]. Brandy, other than Armagnac Brandy or Armagnac, Canadian Brandy, Cognac Brandy or Cognac, Dried Fruit Brandy, Fruit Brandy, Grappa, Lees Brandy and Pomace or Marc,
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of wine; and
(b) may contain
(i) caramel,
(ii) fruit and other botanical substances, and
(iii) flavouring and flavouring preparations.
B.02.051 [S]. Armagnac Brandy or Armagnac shall be brandy manufactured in the Armagnac district of France in accordance with the laws of the French Republic for consumption in that country.
B.02.052 [S]. Canadian Brandy
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of wine that has been fermented in Canada; and
(b) may contain
(i) caramel,
(ii) fruit and other botanical substances, and
(iii) flavouring and flavouring preparations.
B.02.053 [S]. Cognac Brandy or Cognac shall be brandy manufactured in the Cognac district of France in accordance with the laws of the French Republic for consumption in that country.
B.02.054 [S]. Dried Fruit Brandy
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained from sound dried fruit; and
(b) may contain
(i) caramel,
(ii) fruit and other botanical substances, and
(iii) flavouring and flavouring preparations.
B.02.055 [S]. Fruit Brandy
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of
(i) fruit wine or a mixture of fruit wines, or
(ii) a fermented mash of sound ripe fruit other than grapes, or a mixture of sound ripe fruits other than grapes;
(b) may contain
(i) caramel,
(ii) fruit and other botanical substances, and
(iii) flavouring and flavouring preparations; and
(c) may be described on its label as “(naming the fruit) brandy” if all of the fruit or fruit wine used to make the brandy originates from the named fruit.
B.02.056 [S]. Grappa
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of the pomace from sound ripe grapes after the removal of the juice or wine; and
(b) may contain
(i) caramel
(ii) fruit and other botanical substances, and
(iii) flavouring and flavouring preparations.
B.02.057 [S]. Lees Brandy
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of the lees of wine or fruit wine;
(b) may contain
(i) caramel,
(ii) fruit and other botanical substances, and
(iii) flavouring and flavouring preparations; and
(c) may be described on its label as “(naming the fruit) Lees Brandy” if all of the lees used to make the brandy originate from the named fruit.
B.02.058 [S]. Pomace or Marc
(a) shall be a potable alcoholic distillate, or a mixture of potable alcoholic distillates, obtained by the distillation of the skin and pulp of sound ripe fruit after the removal of the fruit juice, wine or fruit wine;
(b) may contain
(i) caramel,
(ii) fruit and other botanical substances, and
(iii) flavouring and flavouring preparations; and
(c) may be described on its label as “(naming the fruit) Pomace” or “(naming the fruit) Marc” if all of the skin and pulp used to make the brandy originate from the named fruit.
B.02.059 No person shall blend or modify in any manner any brandy that is imported in bulk for the purpose of bottling and sale in Canada as imported brandy, except by
(a) blending with other imported brandy;
(b) the addition of caramel; and
(c) the addition of distilled or otherwise purified water to adjust the brandy to a required strength.
B.02.060 Where brandy is wholly distilled in a country other than Canada, the label shall indicate the country of origin.
B.02.061 (1) No person shall sell any brandy that has not been aged for a period of at least one year in wooden containers or at least six months in small wood.
(2) Nothing in subsection (1) applies in respect of flavouring contained in brandy, but no person shall sell brandy containing any flavouring, other than wine, that has not been aged for a period of at least one year in wooden containers or at least six months in small wood.
(3) Nothing in subsection (1) or (2) applies in respect of brandy that meets the standards prescribed by any of sections B.02.051 to B.02.058.
(4) No person shall make any claim with respect to the age of brandy other than for the period during which the brandy has been held in wooden containers or in small wood.
Liqueurs and Spirituous Cordials
B.02.070 [S]. Liqueur or Spirituous Cordial
(a) shall be a product obtained by the mixing or distillation of alcohol from food sources with or over fruits, flowers, leaves or other botanical substances or their juices or with extracts derived by the infusion, percolation or maceration of those botanical substances;
(b) shall have added, during the course of manufacture, a sweetening agent in an amount that is not less than 2.5 per cent of the finished product;
(c) shall contain not less than 23 per cent absolute alcohol by volume; and
(d) may contain
(i) natural and artificial flavouring preparations, and
(ii) colour.
Vodka
B.02.080 [S]. Vodka shall be a potable alcoholic beverage obtained by the treatment of grain spirit or potato spirit with charcoal so as to render the product without distinctive character, aroma or taste.
Tequila
B.02.090 (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Tequila, or in such a manner that it is likely to be mistaken for Tequila unless it is Tequila manufactured in Mexico as Tequila in accordance with the laws of Mexico applicable in respect of Tequila for consumption in Mexico.
(2) A person may modify Tequila that is imported for the purpose of bottling and sale in Canada as Tequila by the addition of distilled or otherwise purified water to adjust the Tequila to a required strength.
Mezcal
B.02.091 (1) Subject to subsection (2), no person shall label, package, sell or advertise any food as Mezcal, or in such a manner that it is likely to be mistaken for Mezcal unless it is Mezcal manufactured in Mexico as Mezcal in accordance with the laws of Mexico applicable in respect of Mezcal for consumption in Mexico.
(2) A person may modify Mezcal that is imported for the purpose of bottling and sale in Canada as Mezcal by the addition of distilled or otherwise purified water to adjust the Mezcal to a required strength.
Wine
B.02.100 [S]. Wine
(a) shall be an alcoholic beverage that is produced by the complete or partial alcoholic fermentation of fresh grapes, grape must, products derived solely from fresh grapes, or any combination of them;
(b) may have added to it during the course of the manufacture
(i) yeast,
(ii) concentrated grape juice,
(iii) dextrose, fructose, glucose or glucose solids, invert sugar, sugar, or aqueous solutions of any of them,
(iv) yeast foods, in accordance with Table XIV to section B.16.100,
(v) calcium sulphate in such quantity that the content of soluble sulphates in the finished wine shall not exceed 0.2 per cent weight by volume calculated as potassium sulphate,
(vi) calcium carbonate in such quantity that the content of tartaric acid in the finished wine shall not be less than 0.15 per cent weight by volume,
(vii) sulphurous acid, including salts thereof, in such quantity that its content in the finished wine shall not exceed
(A) 70 parts per million in the free state, or
(B) 350 parts per million in the combined state, calculated as sulphur dioxide,
(viii) any of the following substances:
(A) citric acid, fumaric acid, lactic acid, malic acid, potassium bicarbonate, potassium carbonate, potassium citrate and tartaric acid, at a maximum level of use consistent with good manufacturing practice,
(B) metatartaric acid at a maximum level of use of 0.01 per cent, and
(C) potassium acid tartrate at a maximum level of use of 0.42 per cent,
(ix) amylase and pectinase at a maximum level of use consistent with good manufacturing practice,
(x) ascorbic acid or erythorbic acid, or their salts, at a maximum level of use consistent with good manufacturing practice,
(xi) antifoaming agents, in accordance with Table VIII to section B.16.100,
(xii) any of the following fining agents:
(A) activated carbon, albumen, casein, clay, diatomaceous earth, egg white, isinglass, polyvinylpolypyrrolidone and silicon dioxide,
(B) acacia gum, agar, gelatin and potassium ferrocyanide, at a maximum level of use consistent with good manufacturing practice,
(C) tannic acid at a maximum level of use of 200 parts per million, and
(D) polyvinylpyrrolidone in an amount that does not exceed 2 parts per million in the finished product,
(xiii) caramel at a maximum level of use consistent with good manufacturing practice,
(xiv) brandy, fruit spirit or alcohol derived from the alcoholic fermentation of a food source distilled to not less than 94 per cent alcohol by volume,
(xv) any of the following substances:
(A) carbon dioxide and ozone at a maximum level of use consistent with good manufacturing practice, and
(B) oxygen,
(xvi) sorbic acid or salts thereof, not exceeding 500 parts per million calculated as sorbic acid,
(xvii) malolactic bacteria from the genera Lactobacillus, Leuconostoc and Pediococcus,
(xviii) copper sulphate in such a quantity that the content of copper in the finished product shall not exceed 0.0001 per cent,
(xix) nitrogen, and
(xx) oak chips and particles; and
(c) prior to final filtration may be treated with
(i) a strongly acid cation exchange resin in the sodium ion form, or
(ii) a weakly basic anion exchange resin in the hydroxyl ion form.
B.02.101 No person shall sell wine that contains more than 0.24 per cent weight by volume of volatile acidity calculated as acetic acid, as determined by official method FO-2, Determination of Volatile Acidity of Wine, Cider and Champagne Cider, October 15, 1981.
B.02.102 [S]. Fruit spirit shall be an alcoholic distillate obtained from wine, fruit wine, grape pomace or fruit pomace.
B.02.103 [S]. Fruit Wine, or (naming the fruit) Wine shall be the product of the alcoholic fermentation of the juice of sound ripe fruit other than grape, and in all other respects shall meet the requirements of the standard for wine as prescribed by section B.02.100.
B.02.104 [S]. Vermouth shall be wine to which has been added bitters, aromatics or other botanical substances or a flavouring preparation, and shall contain not more than 20 per cent absolute alcohol by volume.
B.02.105 [S]. Flavoured Wine, Wine Cocktail, Aperitif Wine shall be wine to which has been added herbs, spices, other botanical substances, fruit juices or a flavouring preparation, and shall contain not more than 20 per cent absolute alcohol by volume.
B.02.105A [S]. Flavoured (naming the fruit) Wine, (naming the fruit) Wine Cocktail, or Aperitif (naming the fruit) Wine shall be fruit wine, a mixture of fruit wines, or a mixture of fruit wine and wine to which has been added herbs, spices, other botanical substances, fruit juices or a flavouring preparation, and shall contain not more than 20 per cent absolute alcohol by volume.
B.02.106 [S]. Honey Wine
(a) shall be the product of the alcoholic fermentation of an aqueous solution of honey; and
(b) may have added to it during the course of manufacture any of the following substances:
(i) yeast;
(ii) yeast foods;
(iii) sulphurous acid, including salts thereof, in such quantity that its content in the finished wine shall not exceed
(A) 70 ppm in the free state, or
(B) 350 ppm in the combined state, calculated as sulphur dioxide;
(iv) tartaric or citric acid;
(v) potassium acid tartrate;
(vi) natural botanical flavours;
(vii) fruit spirit or alcohol derived from the alcoholic fermentation of a food source distilled to not less than 94 per cent alcohol by volume;
(viii) caramel;
(ix) carbon dioxide;
(x) activated carbon, clay or tannic acid as fining agents; or
(xi) sorbic acid, and any salts thereof, calculated as sorbic acid, in a quantity such that the content of sorbic acid and its salts in the finished wine does not exceed 500 parts per million.
B.02.107 [S]. May Wine shall be wine to which has been added artificial woodruff flavouring preparation.
B.02.108 A clear indication of the country of origin shall be shown on the principal display panel of a wine.
Cider
B.02.120 [S]. Cider
(a) shall
(i) be the product of the alcoholic fermentation of apple juice, and
(ii) contain not less than 2.5 per cent and not more than 13.0 per cent absolute alcohol by volume; and
(b) may have added to it during the course of manufacture
(i) yeast,
(ii) concentrated apple juice,
(iii) sugar, dextrose, invert sugar, glucose, glucose solids, or aqueous solutions thereof,
(iv) yeast foods,
(v) sulphurous acid, including salts thereof, in such quantity that its content in the finished cider shall not exceed
(A) 70 parts per million in the free state, or
(B) 350 parts per million in the combined state, calculated as sulphur dioxide,
(vi) tartaric acid and potassium tartrate,
(vii) citric acid,
(viii) lactic acid,
(ix) pectinase and amylase,
(x) ascorbic or erythorbic acid, or salts thereof,
(xi) any of the following fining agents:
(A) activated carbon,
(B) clay,
(C) diatomaceous earth,
(D) gelatin,
(E) albumen,
(F) sodium chloride,
(G) silica gel,
(H) casein,
(I) tannic acid not exceeding 200 parts per million, or
(J) polyvinylpyrrolidone not exceeding two parts per million in the finished product,
(xii) caramel,
(xiii) brandy, fruit spirit or alcohol derived from the alcoholic fermentation of a food source distilled to not less than 94 per cent alcohol by volume,
(xiv) carbon dioxide,
(xv) oxygen,
(xvi) ozone, or
(xvii) sorbic acid or salts thereof, not exceeding 500 parts per million, calculated as sorbic acid.
B.02.122 [S]. Champagne Cider shall be cider that is impregnated with carbon dioxide under pressure by
(a) conducting the afterpart of the fermentation in closed vessels, or
(b) secondary fermentation in closed vessels with or without the addition of sugar, dextrose, invert sugar, glucose or glucose solids or aqueous solutions thereof,
and shall contain not less than seven per cent absolute alcohol by volume.
B.02.123 No person shall sell cider or champagne cider that has more than 0.2 per cent weight by volume of volatile acidity calculated as acetic acid, as determined by official method FO-2, Determination of Volatile Acidity of Wine, Cider and Champagne Cider, October 15, 1981.
Beer
B.02.130 [S]. Beer
(a) shall be the product of the alcoholic fermentation by yeast of an infusion of barley or wheat malt and hops or hop extract in potable water and shall be brewed in such a manner as to possess the aroma, taste and character commonly attributed to beer; and
(b) may have added to it during the course of manufacture any of the following ingredients:
(i) cereal grain,
(ii) carbohydrate matter,
(iii) salt,
(iv) hop oil,
(v) hop extract, if the hop extract is added to the wort before or during cooking,
(vi) pre-isomerized hop extract,
(vi.1) reduced isomerized hop extract,
(vii) Irish moss seaweed of the species Chondrus crispus,
(viii) carbon dioxide,
(ix) caramel,
(x) dextrin,
(xi) food enzymes,
(xii) stabilizing agents,
(xiii) pH adjusting and water correcting agents,
(xiv) Class I preservatives,
(xv) Class II preservatives,
(xvi) sequestering agent,
(xvii) yeast foods,
(xviii) any of the following fining agents: acacia gum, activated carbon, aluminum silicate, bentonite, calcium silicate, cellulose, China clay, diatomaceous earth, gelatin, isinglass, magnesium silicate, Nylon 66, polyvinylpolypyrrolidone, silica gel and wood shavings derived from beech, cherry, hazelnut and oak wood,
(xix) polyvinylpyrrolidone,
(xx) ammonium persulphate,
(xxi) in the case of wort, dimethylpolysiloxane, and
(xxii) in the case of mash, hydrogen peroxide.
B.02.131 [S]. Ale, Stout, Porter or Malt Liquor
(a) shall be the product of the alcoholic fermentation by yeast of an infusion of barley or wheat malt and hops or hop extract in potable water and shall be brewed in such a manner as to possess the aroma, taste and character commonly attributed to ale, stout, porter, or malt liquor, respectively; and
(b) may have added to it during the course of manufacture any of the ingredients referred to in paragraph B.02.130(b).
B.02.132 Where a beer, ale, stout, porter or malt liquor contains the percentage of alcohol by volume set out in Column I of an item of the table, the qualified common name or common name set out in Column II of that item shall be used in any advertisement of and on the label of the beer, ale, stout, porter or malt liquor.
TABLE
Column IColumn IIItemPercentage alcohol by volumeQualified common name or Common name11.1 to 2.5Extra Light Beer, Extra Light Ale, Extra Light Stout, Extra Light Porter22.6 to 4.0Light Beer, Light Ale, Light Stout, Light Porter34.1 to 5.5Beer, Ale, Stout, Porter45.6 to 8.5Strong Beer, Strong Ale, Strong Stout, Strong Porter, Malt Liquor58.6 or moreExtra Strong Beer, Extra Strong Ale, Extra Strong Stout, Extra Strong Porter, Strong Malt LiquorB.02.133 [S]. In this Division, hop extract means an extract derived from hops by a process employing the solvent
(a) hexane, methanol, or methylene chloride in such a manner that the hop extract does not contain more than 2.2 per cent of the solvent used; or
(b) carbon dioxide or ethyl alcohol in an amount consistent with good manufacturing practice.
B.02.134 [S]. (1) In this Division, pre-isomerized hop extract means an extract derived from hops by
(a) the use of one of the following solvents:
(i) hexane,
(ii) carbon dioxide, or
(iii) ethanol; and
(b) the subsequent isolation of the alpha acids and their conversion to isomerized alpha acids by means of diluted alkali and heat.
(2) For the purposes of paragraph (1)(b), the residues of hexane shall not exceed 1.5 parts per million per per cent iso-alpha acid content of the pre-isomerized hop extract.
B.02.135 [S]. In this Division, reduced isomerized hop extract means
(a) tetrahydroisohumulones derived from hops
(i) by isomerization and reduction of humulones (alpha-acids) by means of hydrogen and a catalyst, or
(ii) by reduction of lupulones (beta-acids) by means of hydrogen and a catalyst, followed by oxidation and isomerization;
(b) hexahydroisohumulones derived from hops by reduction of tetrahydroisohumulones by means of sodium borohydride; and
(c) dihydroisohumulones derived from hops by reduction of isoalpha acids by means of sodium borohydride.
DIVISION 3
Baking Powder
B.03.001 In this Division, acid-reacting material means one or any combination of
(a) lactic acid or its salts;
(b) tartaric acid or its salts;
(c) acid salts of phosphoric acid; and
(d) acid compounds of aluminum.
B.03.002 [S]. Baking Powder shall be a combination of sodium or potassium bicarbonate, an acid-reacting material, starch or other neutral material, may contain an anticaking agent and shall yield not less than 10 per cent of its weight of carbon dioxide, as determined by official method FO-3, Determination of Carbon Dioxide in Baking Powder, October 15, 1981.
DIVISION 4
Cocoa And Chocolate Products
B.04.001 The definitions in this section apply in this Division.
chocolate product
chocolate product means a product derived from one or more cocoa products and includes chocolate, bittersweet chocolate, semi-sweet chocolate, dark chocolate, sweet chocolate, milk chocolate and white chocolate. (produit de chocolat)
cocoa product
cocoa product means a product derived from cocoa beans and includes cocoa nibs, cocoa liquor, cocoa mass, unsweetened chocolate, bitter chocolate, chocolate liquor, cocoa, low fat cocoa, cocoa powder and low fat cocoa powder. (produit du cacao)
milk ingredient
milk ingredient means one or any combination of
(a) the following products for which a standard is prescribed in this Part, namely,
(i) milk or whole milk,
(ii) skim milk,
(iii) partly skimmed milk or partially skimmed milk,
(iv) sterilized milk,
(v) condensed milk or sweetened condensed milk,
(vi) evaporated milk,
(vii) evaporated skim milk or concentrated skim milk,
(viii) evaporated partly skimmed milk or concentrated partly skimmed milk,
(ix) milk powder or whole milk powder or dry whole milk or powdered whole milk,
(x) skim milk powder or dry skim milk,
(xi) skim milk with added milk solids,
(xii) partly skimmed milk with added milk solids or partially skimmed milk with added milk solids,
(xiii) malted milk or malted milk powder,
(xiv) butter, and
(xv) cream; and
(b) the following products for which a standard is not prescribed by this Part, namely
(i) reconstituted milk or whole milk,
(ii) reconstituted skim milk,
(iii) reconstitued partly skimmed milk,
(iv) partly skimmed milk powder,
(v) buttermilk,
(vi) butter oil, and
(vii) reconstituted cream. (ingrédient laitier)
sweetening ingredient
sweetening ingredient means any one or any combination of sweetening agents, except for icing sugar. (ingrédient édulcorant)
B.04.002 [S]. Cocoa Beans shall be the seeds of Theobroma cacao L. or a closely related species.
B.04.003 [S]. Cocoa Nibs shall be the product prepared by removing the shell from cleaned cocoa beans, of which the residual shell content may not exceed 1.75 per cent by mass, calculated to an alkali free basis if the nibs or the cocoa beans from which the nibs were prepared have been processed with alkali, as determined by the method prescribed in the Official Methods of Analysis of the Association of Official Analytical Chemists, 12th Ed. (1975), sections 13.010 to 13.014, under the heading “Shell in Cacao Nibs — Official Final Action”, published by the Association of Official Analytical Chemists, in Washington.
B.04.004 [S]. Cocoa Liquor, Cocoa Mass, Unsweetened Chocolate, Bitter Chocolate or Chocolate Liquor shall
(a) be the product obtained from the mechanical disintegration of the cocoa nib with or without removal or addition of any of its constituents; and
(b) contain not less than 50 per cent cocoa butter.
B.04.005 (1) Cocoa products may be processed with one or more of the following pH-adjusting or alkalizing agents:
(a) hydroxides of ammonia, carbonates of ammonia, bicarbonates of ammonia, hydroxides of sodium, carbonates of sodium, bicarbonates of sodium, hydroxides of potassium, carbonates of potassium or bicarbonates of potassium;
(b) carbonates of magnesium or hydroxides of magnesium; and
(c) carbonates of calcium.
(2) The quantity of any one pH-adjusting agent referred to in paragraphs (1)(a) to (c) shall not exceed the maximum level of use for that agent set out in column III of an item of Table X to section B.16.100.
(3) The total mass of the pH-adjusting agents referred to in paragraphs (1)(a) to (c) shall not be greater in neutralizing value, calculated from the respective masses of those agents, than the neutralizing value of five parts by mass of anhydrous potassium carbonate for each 100 parts by mass of cocoa product, calculated on a fat-free basis.
(4) Cocoa products may be processed with one or more of the following pH-adjusting or neutralizing agents, added as such or in aqueous solution:
(a) phosphoric acid;
(b) citric acid; and
(c) L-tartaric acid.
(5) The total mass of pH-adjusting agents referred to in subsection (4) shall not exceed in neutralizing value, calculated from the respective masses of those agents, the appropriate maximum levels of use set out in column III of Table X to section B.16.100.
(6) For the purpose of subsection (5),
(a) the total quantity of phosphoric acid shall not be greater than 0.5 part by mass, expressed as P2O5, for each 100 parts by mass of cocoa product, calculated on a fat-free basis; and
(b) the total quantity, singly or in combination, of citric acid and L-tartaric acid shall not be greater than 1.0 part by mass for each 100 parts by mass of cocoa product, calculated on a fat-free basis.
B.04.006 [S]. Chocolate, Bittersweet Chocolate, Semi-sweet Chocolate or Dark Chocolate
(a) shall be one or more of the following combined with a sweetening ingredient, namely,
(i) cocoa liquor,
(ii) cocoa liquor and cocoa butter, and
(iii) cocoa butter and cocoa powder;
(b) shall contain not less than 35 per cent total cocoa solids, of which
(i) not less than 18 per cent is cocoa butter, and
(ii) not less than 14 per cent is fat-free cocoa solids; and
(c) may contain
(i) less than 5 per cent total milk solids from milk ingredients,
(ii) spices,
(iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,
(iv) salt, and
(v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely,
(A) mono-glycerides and mono- and diglycerides,
(B) lecithin and hydroxylated lecithin,
(C) ammonium salts of phosphorylated glycerides,
(D) polyglycerol esters of interesterified castor oil fatty acids, and
(E) sorbitan monostearate.
B.04.007 [S]. Sweet Chocolate
(a) shall be one or more of the following combined with a sweetening ingredient, namely,
(i) cocoa liquor,
(ii) cocoa liquor and cocoa butter, and
(iii) cocoa butter and cocoa powder;
(b) shall contain not less than 30 per cent total cocoa solids, of which
(i) 18 per cent is cocoa butter, and
(ii) 12 per cent is fat-free cocoa solids; and
(c) may contain
(i) less than 12 per cent total milk solids from milk ingredients,
(ii) spices,
(iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,
(iv) salt, and
(v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely,
(A) mono-glycerides and mono- and diglycerides,
(B) lecithin and hydroxylated lecithin,
(C) ammonium salts of phosphorylated glycerides,
(D) polyglycerol esters of interesterified castor oil fatty acids, and
(E) sorbitan monostearate.
B.04.008 [S]. Milk Chocolate
(a) shall be one or more of the following combined with a sweetening ingredient, namely,
(i) cocoa liquor,
(ii) cocoa liquor and cocoa butter, and
(iii) cocoa butter and cocoa powder;
(b) shall contain not less than
(i) 25 per cent total cocoa solids, of which
(A) not less than 15 per cent is cocoa butter, and
(B) not less than 2.5 per cent is fat-free cocoa solids,
(ii) 12 per cent total milk solids from milk ingredients, and
(iii) 3.39 per cent milk fat; and
(c) may contain
(i) less than 5 per cent whey or whey products,
(ii) spices,
(iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,
(iv) salt, and
(v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely,
(A) mono-glycerides and mono- and diglycerides,
(B) lecithin and hydroxylated lecithin,
(C) ammonium salts of phosphorylated glycerides,
(D) polyglycerol esters of interesterified castor oil fatty acids, and
(E) sorbitan monostearate.
B.04.009 [S]. White Chocolate
(a) shall contain the following combined together, namely,
(i) not less than 20 per cent cocoa butter,
(ii) not less than 14 per cent total milk solids from milk ingredients, and
(iii) not less than 3.5 per cent milk fat; and
(b) may contain
(i) less than 5 per cent whey or whey products,
(ii) spices,
(iii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,
(iv) salt, and
(v) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of chocolate product, namely,
(A) mono-glycerides and mono- and diglycerides,
(B) lecithin and hydroxylated lecithin,
(C) ammonium salts of phosphorylated glycerides,
(D) polyglycerol esters of interesterified castor oil fatty acids, and
(E) sorbitan monostearate.
B.04.010 [S]. Cocoa or Cocoa Powder
(a) shall be the product that
(i) is obtained by pulverising the remaining material from partially defatted cocoa liquor by mechanical means, and
(ii) contains not less than 10 per cent cocoa butter; and
(b) may contain
(i) spices,
(ii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,
(iii) salt, and
(iv) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of cocoa product, namely,
(A) mono-glycerides and mono- and diglycerides,
(B) lecithin and hydroxylated lecithin, and
(C) ammonium salts of phosphorylated glycerides.
B.04.011 [S]. Low Fat Cocoa or Low Fat Cocoa Powder
(a) shall be the product that:
(i) is obtained by pulverising the remaining material from partially defatted cocoa liquor by mechanical means, and
(ii) contains less than 10 per cent cocoa butter; and
(b) may contain
(i) spices,
(ii) flavouring preparations, other than those that imitate the flavour of chocolate or milk, to balance flavour,
(iii) salt, and
(iv) any of the following emulsifying agents, which singly shall not exceed the maximum level of use set out in column III of Table IV to section B.16.100, and in combination shall not exceed 1.5 per cent by mass of cocoa product, namely,
(A) mono-glycerides and mono- and diglycerides,
(B) lecithin and hydroxylated lecithin, and
(C) ammonium salts of phosphorylated glycerides.
B.04.012 No person shall sell a cocoa product or a chocolate product unless it is free from bacteria of the genus Salmonella as determined by official method MFO-11, Microbiological Examination of Cocoa and Chocolate, November 30, 1981.
DIVISION 5
Coffee
B.05.001 [S]. Green Coffee, Raw Coffee or Unroasted Coffee shall be the seed of Coffee arabica L., C. liberica Hiern, or C. robusta Chev., freed from all but a small portion of its spermoderm.
B.05.002 [S]. Roasted Coffee or Coffee shall be roasted green coffee, and shall contain not less than 10 per cent fat, and may contain not more than six per cent total ash.
B.05.003 [S]. Decaffeinated (indicating the type of coffee)
(a) shall be coffee of the type indicated, from which caffeine has been removed and that, as a result of the removal, contains not more than
(i) 0.1 per cent caffeine, in the case of decaffeinated raw coffee and decaffeinated coffee, or
(ii) 0.3 per cent caffeine, in the case of decaffeinated instant coffee; and
(b) may have been decaffeinated by means of extraction solvents set out in Table XV to Division 16.
Division 6
Food Colours
B.06.001 In this Division,
diluent
diluent means any substance other than a synthetic colour present in a colour mixture or preparation; (diluant)
dye
dye means the principal dye and associated subsidiary and isomeric dyes contained in a synthetic colour; (pigment)
mixture
mixture means a mixture of two or more synthetic colours or a mixture of one or more synthetic colours with one or more diluents; (mélange)
official method FO-7
official method FO-7 means official method FO-7, Determination of Dye Content of Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-7))
official method FO-8
official method FO-8 means official method FO-8, Determination of Water Insoluble Matter in Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-8))
official method FO-9
official method FO-9 means official method FO-9, Determination of Combined Ether Extracts in Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-9))
official method FO-10
official method FO-10 means official method FO-10, Determination of Subsidiary Dyes in Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-1003))
official method FO-11
official method FO-11 means official method FO-11, Determination of Intermediates in Synthetic Food Colours, March 15, 1984; ((méthode officielle FO-11))
official method FO-12
official method FO-12 means official method FO-12, Determination of Volatile Matter in Citrus Red No. 2, March 15, 1984; ((méthode officielle FO-12))
official method FO-13
official method FO-13 means official method FO-13, Determination of Sulphated Ash in Citrus Red No. 2, March 15, 1984; ((méthode officielle FO-13))
official method FO-14
official method FO-14 means official method FO-14, Determination of Water Soluble Matter in Citrus Red No. 2, March 15, 1984; ((méthode officielle FO-14))
official method FO-15
official method FO-15 means offical method FO-15, Determination of Carbon Tetrachloride Insoluble Matter in Citrus Red No. 2, March 15, 1984; ((méthode officielle))
preparation
preparation means a preparation of one or more synthetic colours containing less than three per cent dye and sold for household use; (préparation)
synthetic colour
synthetic colour means any organic colour, other than caramel, that is produced by chemical synthesis and has no counterpart in nature and for which a standard is prescribed in sections B.06.041 to B.06.053. (colorant synthétique)
B.06.002 No person shall sell a food, other than a synthetic colour, mixture, preparation or flavouring preparation, that contains, when prepared for consumption according to label directions, more than
(a) 300 parts per million of Allura Red, Amaranth, Erythrosine, Tartrazine, Sunset Yellow FCF or Indigotine or any combination of those colours;
(b) 100 parts per million of Fast Green FCF or Brilliant Blue FCF or any combination of those colours;
(c) 300 parts per million of any combination of the synthetic colours named in paragraphs (a) and (b) within the limits set by those paragraphs; or
(d) 150 parts per million of Ponceau SX.
B.06.003 No person shall sell a colour for use in or upon food that contains more than
(a) three parts per million of arsenic, calculated as arsenic, as determined by official method FO-4, Determination of Arsenic in Food Colours, October 15, 1981;
(b) 10 parts per million of lead, calculated as lead, as determined by official method FO-5, Determination of Lead in Food Colours, October 15, 1981; or
(c) 40 parts per million of heavy metals, except in the case of iron oxide, titanium dioxide, aluminum metal and silver metal.
B.06.004 No person shall sell a synthetic colour for use in or upon food unless
(a) the label carries the lot number and common name of the synthetic colour and the words “Food Colour”;
(b) the Director, or an agency acceptable to the Director, has certified that each lot meets the requirements of section B.06.003 and the standard for such colour as prescribed in sections B.06.041 to B.06.053; and
(c) where the synthetic colour is certified by an agency, a copy of the certificate has been submitted to and accepted by the Director.
B.06.005 No person shall import a synthetic colour for use in or upon food unless
(a) the Director, or an agency acceptable to the Director, has certified that each lot meets the requirements of section B.06.003 and the standard for such colour as prescribed in sections B.06.041 to B.06.053; and
(b) where the synthetic colour is certified by an agency, a copy of the certificate has been submitted to and accepted by the Director.
B.06.006 No person shall sell a mixture for use in or upon food unless the label carries the lot number of the mixture and the words “Food Colour”.
B.06.007 No person shall sell a preparation for use in or upon food unless
(a) the label carries the words “Food Colour Preparation” on its principal display panel; and
(b) in the case of a liquid preparation, the container has a capacity of 60 ml or less and will permit dropwise discharge only.
B.06.008 No person shall import or sell a mixture or preparation for use in or upon food unless
(a) the Director, or an agency acceptable to the Director, has certified that any synthetic colour contained therein meets the requirements of section B.06.003 and the standard for such colour as prescribed in sections B.06.041 to B.06.053; or
(b) any synthetic colour contained therein has been previously certified and the certificate has been accepted as required by sections B.06.004 and B.06.005.
B.06.009 to B.06.013 [Repealed, SOR/80-500, s. 2]
Natural Colours
B.06.021 [S]. Oil-soluble Annatto, Annatto Butter Colour, or Annatto Margarine Colour
(a) shall be the extractives of Bixa orellana seeds
(i) dissolved in vegetable oil, castor oil, monoglycerides and diglycerides, propylene glycol or propylene glycol monoesters and diesters of fat-forming fatty acids, with or without one per cent potassium hydroxide, or
(ii) suspended upon sugar, lactose, starch or hydrated calcium silicate, with or without calcium phosphate, potassium aluminum sulphate, sodium bicarbonate or salt; and
(b) shall contain not less than 0.30 per cent total pigments calculated as natural (cis-) bixin, which pigments shall consist of not less than 40 per cent natural (cis-) bixin.
B.06.022 [S]. ß-Carotene shall be the food colour chemically known as ß-carotene that is manufactured synthetically and shall conform to the following specifications:
(a) one per cent solution in chloroform clear;
(b) loss of weight on drying not more than 0.2 per cent;
(c) residue on ignition not more than 0.2 per cent; and
(d) assay (spectrophotometric) 96 to 101 per cent.
B.06.023 [S]. ß-Apo-8′-Carotenal shall be the food colour chemically known as ß-apo-8′-carotenal and shall conform to the following specifications:
(a) one per cent solution in chloroform clear;
(b) melting point (decomposition) 136°C. to 140°C (corrected);
(c) loss of weight on drying not more than 0.2 per cent;
(d) residue on ignition not more than 0.2 per cent; and
(e) assay (spectrophotometric) 96 to 101 per cent.
B.06.024 [S]. Canthaxanthin shall be the food colour chemically known as canthaxanthin and shall conform to the following specifications:
(a) one per cent solution in chloroform clear;
(b) loss of weight on drying not more than 0.2 per cent;
(c) assay (spectrophotometric) 96 to 101 per cent.
B.06.025 [S]. Ethyl ß-apo-8′-carotenoate shall be the food colour chemically known as ethyl ß-apo-8′-carotenoate and shall conform to the following specifications:
(a) one per cent solution in chloroform clear
(b) loss of weight on drying not more than 0.2 per cent, and
(c) assay (spectrophotometric) 96 to 101 per cent.
Inorganic Colours
B.06.031 [S]. Carbon black shall be carbon prepared from natural gas by the “channel” or “impingement” process and shall contain no higher aromatic hydrocarbons or tarry materials as determined by official method FO-6, Determination of Higher Aromatic Hydrocarbons or Tarry Materials in Carbon Black and Charcoal, October 15, 1981.
B.06.032 [S]. Charcoal shall be carbon prepared by the incomplete combustion of vegetable matter and shall contain no higher aromatic hydrocarbons or tarry materials as determined by official method FO-6, Determination of Higher Aromatic Hydrocarbons or Tarry Materials in Carbon Black and Charcoal, October 15, 1981.
B.06.033 [S]. Titanium Dioxide shall be the chemical substance known as titanium dioxide and shall contain not less than 99 per cent titanium dioxide, and notwithstanding section B.06.006, shall contain not more than 50 parts per million of total antimony expressed as the metal and as determined by an acceptable method.
Synthetic Colours
B.06.041 [S]. Amaranth shall be the trisodium salt of 1-(4-sulpho-1-naphthylazo)-2-naphthol-3,6-disulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than
(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;
(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;
(c) 4.0 per cent subsidiary dyes, as determined by official method FO-10; and
(d) 0.5 per cent intermediates, as determined by official method FO-11.
B.06.042 [S]. Erythrosine shall be the disodium salt of 2,4,5,7-tetraiodofluorescein, shall contain not less than 85 per cent dye calculated as the monohydrate, as determined by official method FO-7, and may contain not more than
(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;
(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;
(c) 5.0 per cent subsidiary dyes, as determined by official method FO-10; and
(d) 0.5 per cent intermediates, as determined by official method FO-11.
B.06.043 [S]. Ponceau SX shall be the disodium salt of 2-(5-sulpho-2,4-xylylazo)-1-naphthol-4-sulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than
(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;
(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;
(c) 1.0 per cent subsidiary dyes, as determined by official method FO-10; and
(d) 0.5 per cent intermediates, as determined by official method FO-11.
B.06.044 [S]. Allura Red shall be the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulphophenyl)azo]-2-naphthalene sulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than
(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;
(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;
(c) 4.0 per cent subsidiary dyes, as determined by official method FO-10; and
(d) 0.5 per cent intermediates, as determined by official method FO-11.
B.06.045 [S]. Tartrazine shall be the trisodium salt of 3-carboxy-5-hydroxy-1-p-sulphophenyl-4-p-sulphophenyl-azopyrazole, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than
(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;
(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;
(c) 1.0 per cent subsidiary dyes, as determined by official method FO-10; and
(d) 0.5 per cent intermediates, as determined by official method FO-11.
B.06.046 [S]. Sunset Yellow FCF shall be the disodium salt of 1-p-sulphophenylazo-2-naphthol-6-sulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than
(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;
(b) 0.2 per cent combined ether extracts, as determined by official method FO-9;
(c) 5.0 per cent subsidiary dyes, as determined by official method FO-10; and
(d) 0.5 per cent intermediates, as determined by official method FO-11.
B.06.049 [S]. Fast Green FCF shall be the disodium salt of 4,4′-di(N-ethyl-m-sulphobenzylamino)-2″-sulpho-4″-hydroxytriphenylmethanol anhydride, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than
(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;
(b) 0.4 per cent combined ether extracts, as determined by official method FO-9;
(c) 5.0 per cent subsidiary dyes, as determined by official method FO-10; and
(d) 1.0 per cent intermediates, as determined by official method FO-11.
B.06.050 [S]. Indigotine shall be the disodium salt of indigotine-5,5′-disulphonic acid, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than
(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;
(b) 0.4 per cent combined ether extracts, as determined by official method FO-9;
(c) 1.0 per cent subsidiary dyes, as determined by official method FO-10; and
(d) 0.5 per cent intermediates, as determined by official method FO-11.
B.06.051 [S]. Brilliant Blue FCF shall be the disodium salt of 4,4′-di (N-ethyl-m-sulphobenzylamino)-2″-sulphotriphenylmethanol anhydride, shall contain not less than 85 per cent dye, as determined by official method FO-7, and may contain not more than
(a) 0.2 per cent water insoluble matter, as determined by official method FO-8;
(b) 0.4 per cent combined ether extracts, as determined by official method FO-9;
(c) 5.0 per cent subsidiary dyes, as determined by official method FO-10; and
(d) 2.0 per cent intermediates, as determined by official method FO-11.
B.06.053 [S]. Citrus Red. No. 2 shall be 1-(2,5-dimethoxyphenylazo)-2-naphthol, shall contain not less than 98 per cent dye, as determined by official method FO-7, and may contain not more than
(a) 0.5 per cent volatile matter (at 100°C), as determined by official method FO-12;
(b) 0.3 per cent sulphated ash, as determined by official method FO-13;
(c) 0.3 per cent water soluble matter, as determined by official method FO-14;
(d) 0.5 per cent carbon tetrachloride insoluble matter, as determined by official method FO-15;
(e) 0.05 per cent uncombined intermediates; and
(f) 2.0 per cent subsidiary dyes.
B.06.061 The lake of any water soluble synthetic colour for which a standard is provided in sections B.06.041, B.06.042, B.06.043, B.06.044, B.06.045, B.06.046, B.06.049, B.06.050 or B.06.051 shall be the calcium or aluminum salt of the respective colour extended on alumina.
B.06.062 [Repealed, SOR/82-768, s. 13]
DIVISION 7
Spices, Dressings And Seasonings
B.07.001 [S]. Allspice or Pimento, whole or ground, shall be the dried, full but unripe whole berries of Pimenta dioica (L) Merr. and shall contain
(a) not more than
(i) 25 per cent crude fibre,
(ii) 5.5 per cent total ash,
(iii) 0.4 per cent ash insoluble in hydrochloric acid, and
(iv) 12 per cent moisture; and
(b) not less than 2.5 millilitres volatile oil per 100 grams of spice.
B.07.002 [S]. Anise or Anise Seed, whole or ground, shall be the dried fruit of Pimpinella anisum L. and shall contain
(a) not more than
(i) nine per cent total ash,
(ii) one per cent ash insoluble in hydrochloric acid, and
(iii) 10 per cent moisture; and
(b) not less than two millilitres volatile oil per 100 grams of spice.
B.07.003 [S]. Basil or Sweet Basil, whole or ground, shall be the dried leaves of Ocimum basilicum L. and shall contain
(a) not more than
(i) 15 per cent total ash,
(ii) two per cent ash insoluble in hydrochloric acid, and
(iii) nine per cent moisture; and
(b) not less than 0.2 millilitre volatile oil per 100 grams of spice.
B.07.004 [S]. Bay Leaves or Laurel Leaves, whole or ground, shall be the dried leaves of Laurus nobilis L. and shall contain
(a) not more than
(i) 4.5 per cent total ash,
(ii) 0.5 per cent ash insoluble in hydrochloric acid, and
(iii) seven per cent moisture; and
(b) not less than one millilitre volatile oil per 100 grams of spice.
B.07.005 [S]. Caraway or Caraway Seed, whole or ground, shall be the dried fruit of the caraway plant, Carum carvi L. and shall contain
(a) not more than
(i) eight per cent total ash,
(ii) one per cent ash insoluble in hydrochloric acid, and
(iii) 11.5 per cent moisture; and
(b) not less than two millilitres volatile oil per 100 grams of spice.
B.07.006 [S]. Cardamom or Cardamom Seed, bleached or green, whole or ground, shall be the dried ripe fruit of Elettaria cardamomum Maton and shall contain
(a) not more than
(i) eight per cent total ash,
(ii) three per cent ash insoluble in hydrochloric acid, and
(iii) 13 per cent moisture; and
(b) not less than three millilitres volatile oil per 100 grams of spice.
B.07.007 [S]. Cayenne Pepper or Cayenne, whole or ground,
(a) shall be the dried ripe fruit of Capsicum frutescens L., Capsicum baccatum L., or other small-fruited species of Capsicum and shall contain not more than
(i) 1.5 per cent starch,
(ii) 28 per cent crude fibre,
(iii) 10 per cent total ash,
(iv) 1.5 per cent ash insoluble in hydrochloric acid, and
(v) 10 per cent moisture; and
(b) may contain silicon dioxide as an anti-caking agent in an amount not exceeding 2.0 per cent.
B.07.008 [S]. Celery Salt
(a) shall be a combination of
(i) ground celery seed or ground dehydrated celery, and
(ii) salt in an amount not exceeding 75 per cent; and
(b) may contain silicon dioxide as an anticaking agent in an amount not exceeding 0.5 per cent.
B.07.009 [S]. Celery Seed, whole or ground, shall be the dried ripe fruit of Apium graveolens L. and shall contain
(a) not more than
(i) 12 per cent total ash,
(ii) two per cent ash insoluble in hydrochloric acid, and
(iii) 10 per cent moisture; and
(b) not less than 1.5 millilitres volatile oil per 100 grams of spice.
B.07.010 [S]. Celery Pepper
(a) shall be a combination of
(i) ground celery seed or ground dehydrated celery, and
(ii) ground black pepper in an amount not exceeding 70 per cent; and
(b) may contain silicon dioxide as an anticaking agent in an amount not exceeding 0.5 per cent.
B.07.011 [S]. Cinnamon or Cassia, whole or ground, shall be the dried bark of trees of the genus Cinnamomum of Species C. burmanni Blume, C. loureirii Nees or C. Cassia Blume and shall contain
(a) not more than
(i) six per cent total ash,
(ii) two per cent ash insoluble in hydrochloric acid, and
(iii) 13 per cent moisture; and
(b) not less than 1.2 millilitres volatile oil per 100 grams of spice.
B.07.012 [S]. Ceylon Cinnamon, whole or ground, shall be cinnamon obtained exclusively from Cinnamomum zeylanicum Nees.
B.07.013 [S]. Cloves, whole or ground, shall be the dried unopened flower buds of Eugenia caryophyllus (Spreng) and shall contain
(a) not more than
(i) five per cent clove stems,
(ii) six per cent total ash,
(iii) 0.5 per cent ash insoluble in hydrochloric acid,
(iv) 10 per cent crude fibre, and
(v) eight per cent moisture; and
(b) not less than 13 millilitres volatile oil per 100 grams of spice.
B.07.014 [S]. Coriander or Coriander Seed, whole or ground, shall be the dried fruit of Coriandrum sativum L. and shall contain
(a) not more than
(i) seven per cent total ash,
(ii) one per cent ash insoluble in hydrochloric acid, and
(iii) nine per cent moisture; and
(b) not less than 0.3 millilitre volatile oil per 100 grams of spice.
B.07.015 [S]. Cumin or Cumin Seed, whole or ground, shall be the dried seeds of Cuminum cyminum L. and shall contain
(a) not more than
(i) 9.5 per cent total ash,
(ii) 1.5 per cent ash insoluble in hydrochloric acid, and
(iii) nine per cent moisture; and
(b) not less than 2.5 millilitres volatile oil per 100 grams of spice.
B.07.016 [S]. Curry Powder shall be any combination of
(a) turmeric with spices and seasoning; and
(b) salt in an amount not exceeding five per cent.
B.07.017 [S]. Dill Seed, whole or ground, shall be the dried fruit of Anethum graveolens L., or Anethum sowa D.C. and shall contain
(a) not more than
(i) 10 per cent total ash,
(ii) two per cent ash insoluble in hydrochloric acid, and
(iii) nine per cent moisture; and
(b) not less than two millilitres volatile oil per 100 grams of spice.
B.07.018 [S]. Fennel or Fennel Seed, whole or ground, shall be the dried ripe fruit of Foeniculum vulgare Mill. and shall contain
(a) not more than
(i) 10 per cent total ash,
(ii) one per cent ash insoluble in hydrochloric acid, and
(iii) 10 per cent moisture; and
(b) not less than one millilitre volatile oil per 100 grams of spice.
B.07.019 [S]. Fenugreek, whole or ground, shall be the dried ripe fruit of Trigonella foenumgraecum L. and shall contain not more than
(a) five per cent total ash;
(b) one per cent ash insoluble in hydrochloric acid; and
(c) 10 per cent moisture.
B.07.020 [S]. Garlic Salt
(a) shall be a combination of
(i) powdered dehydrated garlic, and
(ii) salt in an amount not exceeding 75 per cent; and
(b) may contain one or more of the following anticaking agents in a total amount not exceeding two per cent:
calcium aluminum silicate, calcium phosphate tribasic, calcium silicate, calcium stearate, magnesium carbonate, magnesium silicate, magnesium stearate, silicone dioxide in an amount not exceeding one per cent and sodium aluminum silicate.
B.07.021 [S]. Ginger whole or ground, shall be the washed and dried or decorticated rhizome of Zingiber officinale Roscoe and shall contain
(a) not more than
(i) seven per cent total ash,
(ii) one per cent ash insoluble in hydrochloric acid, and
(iii) 12.5 per cent moisture; and
(b) not less than 1.5 millilitres volatile oil per 100 grams of spice.
B.07.022 [S]. Mace, whole or ground, shall be the dried arillus of Myristica fragrans Houttyn and shall contain
(a) not more than
(i) 3.5 per cent total ash,
(ii) 0.5 per cent ash insoluble in hydrochloric acid, and
(iii) eight per cent moisture, and
(b) not less than 11 millilitres volatile oil per 100 grams of spice,
and the total non-volatile extracts obtainable therefrom by
(c) ethyl ether, shall not be less than 20 per cent nor more than 35 per cent, and
(d) ethyl ether, after preliminary extraction with petroleum ether, shall not exceed five per cent.
B.07.023 [S]. Marjoram, whole or ground, shall be the dried leaves, with or without a small proportion of the flowering tops, of Marjorana hortensis Moench and shall contain
(a) not more than
(i) 10 per cent stems and foreign material of plant origin,
(ii) 13.5 per cent total ash,
(iii) 4.5 per cent ash insoluble in hydrochloric acid, and
(iv) 10 per cent moisture; and
(b) not less than 0.7 millilitre volatile oil per 100 grams of spice.
B.07.024 [S]. Mustard Seed shall be the seed of Sinapis alba, Brassica hirta Moench, Brassica juncea (L) Cosson or Brassica nigra and shall contain
(a) not more than
(i) seven per cent total ash,
(ii) one per cent ash insoluble in hydrochloric acid, and
(iii) 11 per cent moisture; and
(b) not less than 25 per cent non-volatile ether extract.
B.07.025 [S]. Mustard, Mustard Flour or Ground Mustard shall be powdered mustard seed
(a) made from mustard seed from which
(i) most of the hulls have been removed, and
(ii) a portion of the fixed oil may have been removed; and
(b) that contains not more than
(i) 1.5 per cent starch, and
(ii) eight per cent total ash, on an oil-free basis.
B.07.026 [S]. Nutmeg, whole or ground, shall be the dried seed of Myristica fragrans Houttyn and may, prior to grinding, have a thin coating of lime and shall contain
(a) not more than
(i) three per cent total ash,
(ii) 0.5 per cent ash insoluble in hydrochloric acid, and
(iii) eight per cent moisture; and
(b) not less than
(i) 25 per cent non-volatile ether extract, and
(ii) 6.5 millilitres volatile oil per 100 grams of spice.
B.07.027 [S]. Onion Salt
(a) shall be a combination of
(i) powdered dehydrated onion, and
(ii) salt in an amount not exceeding 75 per cent; and
(b) may contain one or more of the following anticaking agents in a total amount not exceeding two per cent:
calcium aluminum silicate, calcium phosphate tribasic, calcium silicate, calcium stearate, magnesium carbonate, magnesium silicate, magnesium stearate, silicon dioxide in an amount not exceeding one per cent and sodium aluminum silicate.
B.07.028 [S]. Oregano, whole or ground, shall be the dried leaves of Origanum vulgar L. or Origanum Spp. and shall contain
(a) not more than
(i) 10 per cent total ash,
(ii) two per cent ash insoluble in hydrochloric acid, and
(iii) 10 per cent moisture; and
(b) not less than 2.5 millilitres volatile oil per 100 grams of spice.
B.07.029 [S]. Paprika shall be the dried, ground ripe fruit of Capsicum annuum L. and
(a) shall contain not more than
(i) 23 per cent crude fibre,
(ii) 8.5 per cent total ash,
(iii) one per cent ash insoluble in hydrochloric acid, and
(iv) 12 per cent moisture; and
(b) may contain silicon dioxide as an anti-caking agent in an amount not exceeding 2.0 per cent.
B.07.030 [S]. Black Pepper or Peppercorn, whole or ground, shall be the dried, immature berry of Piper nigrum L. and shall contain
(a) not more than
(i) seven per cent total ash,
(ii) one per cent ash insoluble in hydrochloric acid, and
(iii) 12 per cent moisture;
(b) not less than
(i) six per cent non-volatile methylene chloride extract,
(ii) 30 per cent pepper starch, and
(iii) 2.0 millilitres volatile oil per 100 grams of spice; and
(c) when ground, all the parts of the berry in their normal proportions.
B.07.031 [S]. White Pepper, whole or ground, shall be the dried, mature berry of Piper nigrum L., from which the outer coating is and the inner coating may be removed and shall contain
(a) not more than
(i) five per cent crude fibre,
(ii) 2.5 per cent total ash,
(iii) 0.3 per cent ash insoluble in hydrochloric acid, and
(iv) 15 per cent moisture; and
(b) not less than
(i) six per cent non-volatile methylene chloride extract,
(ii) 52 per cent pepper starch, and
(iii) one millilitre volatile oil per 100 grams of spice.
B.07.032 [S]. Poppy seed shall be the dried seed of Papaver somniferum L. and shall contain
(a) not more than
(i) seven per cent total ash, and
(ii) one per cent ash insoluble in hydrochloric acid; and
(b) not less than 40 per cent non-volatile ether extract.
B.07.033 [S]. Rosemary, whole or ground, shall be the dried leaves of Rosemarinus officinalis L. and shall contain
(a) not more than
(i) 7.5 per cent total ash,
(ii) one per cent ash insoluble in hydrochloric acid, and
(iii) nine per cent moisture; and
(b) not less than 1.2 millilitres volatile oil per 100 grams of spice.
B.07.034 [S]. Sage, whole or ground, shall be the dried leaves of the sage plant Salvia officinalis L., Salvia triloba L. or Salvia lavandulaefolia Vahl. and shall contain
(a) not more than
(i) 12 per cent stems excluding petioles and foreign material of plant origin,
(ii) 10 per cent total ash,
(iii) one per cent ash insoluble in hydrochloric acid, and
(iv) 10 per cent moisture; and
(b) not less than one millilitre volatile oil per 100 grams of spice.
B.07.035 [S]. Savory, whole or ground, shall be the dried leaves and flowering tops of Satureja hortensis L. or Satureja montana L. and shall contain
(a) not more than
(i) 11 per cent total ash,
(ii) two per cent ash insoluble in hydrochloric acid, and
(iii) 14 per cent moisture; and
(b) not less than 0.8 millilitre volatile oil per 100 grams of spice.
B.07.036 [S]. Sesame Seed shall be the dried hulled seed of Sesamum indicum L. and shall contain
(a) not more than eight per cent moisture; and
(b) not less than 50 per cent non-volatile ether extract.
B.07.037 [S]. Tarragon, whole or ground, shall be the dried leaves and flowering tops of Artemisia dracunculus L. and shall contain
(a) not more than
(i) 15 per cent total ash,
(ii) 1.5 per cent ash insoluble in hydrochloric acid, and
(iii) 10 per cent moisture; and
(b) not less than 0.3 millilitre volatile oil per 100 grams of spice.
B.07.038 [S]. Thyme, whole or ground, shall be the dried leaves and flowering tops of the thyme plant Thymus vulgaris L. or Thymus zygis L. and shall contain
(a) not more than
(i) 12 per cent total ash,
(ii) five per cent ash insoluble in hydrochloric acid, and
(iii) nine per cent moisture; and
(b) not less than 0.9 millilitre volatile oil per 100 grams of spice.
B.07.039 [S]. Turmeric, whole or ground, shall be the dried rhizome of Curcuma longa L. and shall contain
(a) not more than
(i) seven per cent total ash,
(ii) 1.5 per cent ash insoluble in hydrochloric acid, and
(iii) 10 per cent moisture; and
(b) not less than 3.5 millilitres volatile oil per 100 grams of spice.
B.07.040 [S]. Mayonnaise, Mayonnaise Dressing or Mayonnaise Salad Dressing
(a) shall be a combination of
(i) vegetable oil,
(ii) whole egg or egg yolk, in liquid, frozen or dried form, and
(iii) vinegar or lemon juice;
(b) may contain
(i) water,
(ii) salt,
(iii) a sweetening agent,
(iv) spice or other seasoning except turmeric or saffron,
(v) citric, tartaric or lactic acid, and
(vi) a sequestering agent; and
(c) shall contain not less than 65 per cent vegetable oil.
B.07.041 [S]. French Dressing
(a) shall be a combination of
(i) vegetable oil, and
(ii) vinegar or lemon juice;
(b) may contain
(i) water,
(ii) salt,
(iii) a sweetening agent,
(iv) spice, tomato or other seasoning,
(v) an emulsifying agent,
(vi) whole egg or egg yolk, in liquid, frozen or dried form,
(vii) citric, tartaric or lactic acid, and
(viii) a sequestering agent; and
(c) shall contain not less than 35 per cent vegetable oil.
B.07.042 [S]. Salad Dressing
(a) shall be a combination of
(i) vegetable oil,
(ii) whole egg or egg yolk, in liquid, frozen or dried form,
(iii) vinegar or lemon juice, and
(iv) starch, flour, rye flour or tapioca flour or any combination thereof;
(b) may contain
(i) water,
(ii) salt,
(iii) a sweetening agent,
(iv) spice or other seasoning,
(v) an emulsifying agent,
(vi) citric, tartaric or lactic acid, and
(vii) a sequestering agent; and
(c) shall contain not less than 35 per cent vegetable oil.
B.07.043 No person shall sell a dressing that contains more than five per cent C22 Monoenoic Fatty Acids calculated as a proportion of the total fatty acids contained in the dressing.
DIVISION 8
Dairy Products
B.08.001 The foods referred to in this Division are dairy products.
B.08.001.1 In this Division, milk product means
(a) with respect to butter, whey butter or cheese, any of the following products, namely,
(i) partly skimmed milk, skim milk, cream, buttermilk and whey cream, and
(ii) milk in concentrated, dried or reconstituted form and any product referred to in subparagraph (i) in concentrated, dried or reconstituted form,
(b) with respect to cream cheese spread, cream cheese spread with named added ingredients, processed cheese food, processed cheese food with named added ingredients, processed cheese spread, processed cheese spread with named added ingredients, cold-pack cheese food or cold-pack cheese food with named added ingredients, any of the following products, namely,
(i) butter, whey butter and whey, and
(ii) any product referred to in subparagraph (i) in concentrated or dried form, including whey protein concentrate, and
(c) with respect to ice milk mix, ice cream mix or sherbet, any of the products referred to in subparagraph (a)(i) or (ii) or (b)(i) or (ii). (produit du lait)
B.08.002 Except as provided in these Regulations, a dairy product that contains a fat other than milk fat is adulterated.
B.08.002.1 Sections B.08.003 to B.08.028 do not apply to a lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, or a product or derivative of such secretion.
B.08.002.2 (1) Subject to subsection (2), no person shall sell the normal lacteal secretion obtained from the mammary gland of the cow, genus Bos, or of any other animal, or sell a dairy product made with any such secretion, unless the secretion or dairy product has been pasteurized by being held at a temperature and for a period that ensure the reduction of the alkaline phosphatase activity so as to meet the tolerances specified in official method MFO-3, Determination of Phosphatase Activity in Dairy Products, dated November 30, 1981.
(2) Subsection (1) does not apply to
(a) cheese; or
(b) any food that is sold for further manufacturing or processing in order to pasteurize it in the manner described in subsection (1).
Milk
B.08.003 [S]. Milk or Whole Milk
(a) shall be the normal lacteal secretion obtained from the mammary gland of the cow, genus Bos; and
(b) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.
B.08.004 [S]. Skim Milk
(a) shall be milk that contains not more than 0.3 per cent milk fat;
(b) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and
(c) shall contain vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.
B.08.005 [S]. Partly Skimmed Milk or Partially Skimmed Milk
(a) shall be derived from milk that has had its fat content reduced by mechanical separation or adjusted by the addition of cream, milk, partly skimmed milk or skim milk, either singly or in combination;
(b) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and
(c) shall contain vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.
B.08.006 [S]. Milk Fat or Butter Fat shall be the fat of cow’s milk, and shall have
(a) a specific gravity of not less than 0.905 at a temperature of 40°,
(b) a tocopherol content not greater than 50 micrograms per gram, as determined by official method FO-16, Determination of Tocopherol in Milk Fat or Butter Fat, October 15, 1981,
(c) a Reichert-Meissl number not less than 24, and
(d) a Polenske number not exceeding 10 per cent of the Reichert-Meissl number and in no case shall the Polenske number exceed 3.5, and
where the tocopherol content is greater than 50 micrograms per gram or the Polenske number exceeds 10 per cent of the Reichert-Meissl number, there shall be deemed to have been an addition to the milk fat of fat other than that of cow’s milk.
B.08.007 [S]. Sterilized Milk
(a) and (b) [Repealed, SOR/97-148, s. 1]
(c) shall contain not less than
(i) 11.75 per cent milk solids, and
(ii) 3.25 per cent milk fat; and
(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.
B.08.008 The percentage of milk fat contained in
(a) partly skimmed milk or partially skimmed milk,
(b) partly skimmed milk with added milk solids or partially skimmed milk with added milk solids, or
(c) evaporated partly skimmed milk or concentrated partly skimmed milk
shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.
B.08.009 [S]. Condensed Milk or Sweetened Condensed Milk shall be milk from which water has been evaporated and to which has been added sugar, dextrose, glucose, glucose solids or lactose, or any combination thereof, may contain added vitamin D and shall contain not less than
(a) 28 per cent milk solids; and
(b) eight per cent milk fat.
B.08.010 [S]. Evaporated Milk
(a) shall be milk from which water has been evaporated;
(b) shall contain not less than
(i) 25.0 per cent milk solids, and
(ii) 7.5 per cent milk fat;
(c) shall, notwithstanding sections D.01.009 to D.01.011, contain added vitamin C in such an amount that a reasonable daily intake of the milk contains not less than 60 milligrams and not more than 75 milligrams of vitamin C;
(d) shall contain vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and
(e) may contain
(i) added disodium phosphate or sodium citrate, or both, and
(ii) an emulsifying agent.
B.08.011 [S]. Evaporated Skim Milk or Concentrated Skim Milk
(a) shall be milk that has been concentrated to at least one-half of its original volume by the removal of water;
(b) shall contain
(i) not more than 0.3 per cent milk fat, and
(ii) not less than 17.0 per cent milk solids other than fat;
(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;
(d) shall, notwithstanding sections D.01.009 to D.01.011, contain added vitamin C in such an amount that a reasonable daily intake of the milk contains not less than 60 milligrams and not more than 75 milligrams of vitamin C;
(e) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and
(f) may contain added disodium phosphate or sodium citrate, or both.
B.08.012 [S]. Evaporated Partly Skimmed Milk or Concentrated Partly Skimmed Milk
(a) shall be milk from which part of the milk fat has been removed;
(b) shall be concentrated to at least one-half its original volume by the removal of water;
(c) shall contain not less than 17.0 per cent milk solids other than fat; and
(d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;
(e) shall, notwithstanding sections D.01.009 to D.01.011, contain added vitamin C in such an amount that a reasonable daily intake of the milk contains not less than 60 milligrams and not more than 75 milligrams of vitamin C;
(f) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and
(g) may contain
(i) an emulsifying agent, and
(ii) added disodium phosphate or sodium citrate, or both.
B.08.013 [S]. Milk Powder, Whole Milk Powder, Dry Whole Milk, or Powdered Whole Milk
(a) shall be dried milk;
(b) shall contain not less than
(i) 95 per cent milk solids, and
(ii) 26 per cent milk fat;
(c) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and
(d) may contain the emulsifying agent lecithin in an amount not exceeding 0.5 per cent.
B.08.014 [S]. Skim Milk Powder or Dry Skim Milk
(a) shall be dried skim milk;
(b) shall contain not less than 95 per cent milk solids; and
(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;
(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and
(e) may contain an anti-foaming agent.
B.08.014A No person shall sell milk powder, whole milk powder, dry whole milk, powdered whole milk, skim milk powder or dry skim milk unless it is free from bacteria of the genus Salmonella, as determined by official method MFO-12, Microbiological Examination of Milk Powder, November 30, 1981.
B.08.015 No person shall sell milk, skim milk, partly skimmed milk, (naming the flavour) milk, (naming the flavour) skim milk, (naming the flavour) partly skimmed milk, skim milk with added milk solids, partly skimmed milk with added milk solids, (naming the flavour) skim milk with added milk solids, (naming the flavour) partly skimmed milk with added milk solids, condensed milk, evaporated milk, evaporated skim milk, evaporated partly skimmed milk, milk powder or skim milk powder, in which the vitamin content has been increased by either irradiation or addition unless
(a) in the case of the addition of vitamin D, the menstruum containing the vitamin D contributes not more than 0.01 per cent fat foreign to milk; and
(b) in cases where the vitamin D content is increased by irradiation, the principal display panel of the label carries the statement “Vitamin D Increased” immediately preceding or following the name of the food, without intervening written, printed or graphic matter.
B.08.016 [S]. (naming the flavour) Milk
(a) shall be the product made from
(i) milk, milk powder, skim milk, skim milk powder, partly skimmed milk, evaporated milk, evaporated partly skimmed milk, evaporated skim milk or cream or any combination thereof,
(ii) a flavouring preparation, and
(iii) a sweetening agent;
(b) shall contain not less than three per cent milk fat;
(c) shall contain added vitamin D in such an amount that a reasonable intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D;
(d) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch; and
(e) may contain not more than 50,000 total aerobic bacteria per cubic centimetre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981.
B.08.017 [S]. (naming the flavour) Skim Milk
(a) shall be the product made from
(i) skim milk, skim milk powder or evaporated skim milk or any combination thereof,
(ii) a flavouring preparation, and
(iii) a sweetening agent;
(b) shall contain not more than 0.3 per cent milk fat;
(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;
(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and
(e) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch.
B.08.018 [S]. (naming the flavour) Partly (Partially) Skimmed Milk
(a) shall be the product made from
(i) milk, milk powder, skim milk, skim milk powder, partly skimmed milk, evaporated milk, evaporated partly skimmed milk, evaporated skim milk or cream or any combination thereof,
(ii) a flavouring preparation, and
(iii) a sweetening agent;
(b) shall contain more than 0.3 per cent and less than 3.0 per cent milk fat;
(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;
(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D;
(e) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch; and
(f) may contain not more than 50,000 total aerobic bacteria per cubic centimetre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981.
B.08.019 [S]. Skim Milk with Added Milk Solids
(a) shall be skim milk to which has been added skim milk powder or evaporated skim milk or both;
(b) shall contain not less than 10 per cent milk solids;
(c) shall contain not more than 0.3 per cent milk fat;
(d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the dairy product contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and
(e) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.
B.08.020 [S]. Partly Skimmed Milk with Added Milk Solids or Partially Skimmed Milk with Added Milk Solids
(a) shall be partly skimmed milk to which has been added skim milk powder, milk powder, evaporated milk, evaporated partly skimmed milk or evaporated skim milk or any combination thereof;
(b) shall contain not less than 10 per cent milk solids not including fat; and
(c) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A; and
(d) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D.
B.08.021 [S]. Malted Milk or Malted Milk Powder
(a) shall be the product made by combining milk with the liquid separated from a mash of ground barley malt and meal;
(b) may have added to it, in such manner as to secure the full enzyme action of the malt extract, salt and sodium bicarbonate or potassium bicarbonate;
(c) may have water removed from it; and
(d) shall contain
(i) not less than 7.5 per cent milk fat, and
(ii) not more than 3.5 per cent moisture.
B.08.022 [S]. (naming the flavour) Malted Milk or (naming the flavour) Malted Milk Powder
(a) shall be malted milk or malted milk powder containing a flavouring preparation; and
(b) may contain lactase.
B.08.023 [S]. (naming the flavour) Skim Milk with Added Milk Solids
(a) shall be the product made from
(i) skim milk, skim milk powder, or evaporated skim milk or any combination thereof,
(ii) a flavouring preparation, and
(iii) a sweetening agent;
(b) shall contain not less than 10 per cent milk solids not including fat;
(c) shall contain not more than 0.3 per cent milk fat;
(d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;
(e) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D; and
(f) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch.
B.08.024 No person shall sell milk for manufacture into dairy products if it contains more than
(a) two million total aerobic bacteria per millilitre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981; or
(b) two milligrams of sediment per 16 fluid ounces, as determined by official method MFO-8, Determination of Sediment in Milk, November 30, 1981.
B.08.025 No manufacturer shall purchase milk for manufacture or manufacture milk into other dairy products if he has reason to believe it does not meet the requirements of section B.08.024.
B.08.026 [S]. (naming the flavour) Partly (Partially) Skimmed Milk with Added Milk Solids
(a) shall be the product made from
(i) milk, milk powder, skim milk, skim milk powder, partly skimmed milk, evaporated milk, evaporated partly skimmed milk, evaporated skim milk or cream or any combination thereof,
(ii) a flavouring preparation, and
(iii) a sweetening agent;
(b) shall contain not less than 10 per cent milk solids not including fat;
(c) shall contain more than 0.3 per cent and less than 3.0 per cent milk fat;
(d) shall, notwithstanding sections D.01.009 and D.01.010, contain added vitamin A in such an amount that a reasonable daily intake of the milk contains not less than 1,200 International Units and not more than 2,500 International Units of vitamin A;
(e) shall contain added vitamin D in such an amount that a reasonable daily intake of the milk contains not less than 300 International Units and not more than 400 International Units of vitamin D;
(f) may contain salt, food colour, lactase, stabilizing agent and not more than 0.5 per cent starch; and
(g) may contain not more than 50,000 total aerobic bacteria per cubic centimetre, as determined by official method MFO-7, Microbiological Examination of Milk, November 30, 1981.
B.08.027 Notwithstanding anything contained in these Regulations, the following dairy products that are used in or sold for the manufacture of other foods are not required to contain added vitamins: milk; partly skimmed milk; partially skimmed milk; skim milk; sterilized milk; evaporated milk; evaporated skim milk; concentrated skim milk; evaporated partly skimmed milk; concentrated partly skimmed milk; milk powder; dry whole milk; powdered whole milk; skim milk powder; dry skim milk; partly skimmed milk powder; partially skimmed milk powder; skim milk with added milk solids; partly skimmed milk with added milk solids; and partially skimmed milk with added milk solids.
B.08.028 (1) The percentage of milk fat contained in
(a) (naming the flavour) milk,
(b) (naming the flavour) partly (partially) skimmed milk,
(c) (naming the flavour) partly (partially) skimmed milk with added milk solids,
(d) cream, and
(e) sour cream,
shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.
(2) In addition to the statement referred to in subsection (1), a person may, on the label of a food referred to in that subsection, make a declaration of the fat content of the food, expressed in grams per serving of stated size.
Goat’s Milk
B.08.028.1 A lacteal secretion obtained from themammary gland of any animal other than a cow, genus Bos, and a product or derivative of such secretion shall be labelled so as to identify that animal.
B.08.029 (1) Notwithstanding sections D.01.009 to D.01.011, no person shall sell goat’s milk or goat’s milk powder to which vitamin D has been added unless the goat’s milk or goat’s milk powder contains not less than 35 International Units and not more than 45 International Units of vitamin D per 100 mL of the food when ready-to-serve.
(2) Notwithstanding sections D.01.009 to D.01.011, no person shall sell partly skimmed goat’s milk, skimmed goat’s milk, partly skimmed goat’s milk powder or skimmed goat’s milk powder to which vitamins have been added unless the product contains not less than 35 International Units of vitamin D and 140 International Units of vitamin A and not more than 45 International Units of vitamin D and 300 International Units of vitamin A per 100 mL of food when ready-to-serve.
(3) Notwithstanding sections D.01.009 to D.01.011, no person shall sell evaporated goat’s milk to which vitamins have been added unless 100 mL of the evaporated goat’s milk, when reconstituted according to directions for use, contains not less than seven milligrams of vitamin C, 35 International Units of vitamin D and 10 micrograms of folic acid and not more than nine milligrams of vitamin C, 45 International Units of vitamin D and 20 micrograms of folic acid.
(4) Notwithstanding sections D.01.009 to D.01.011, no person shall sell evaporated partly skimmed goat’s milk or evaporated skimmed goat’s milk to which vitamins have been added unless 100 mL of the evaporated partly skimmed goat’s milk or the evaporated skimmed goat’s milk, when reconstituted according to directions for use, contains not less than 140 International Units of vitamin A, seven milligrams of vitamin C, 35 International Units of vitamin D and 10 micrograms of folic acid and not more than 300 International Units of vitamin A, nine milligrams of vitamin C, 45 International Units of vitamin D and 20 micrograms of folic acid.
Cheese
B.08.030 (1) In this Division, when used with respect to cheese,
pasteurized source
pasteurized source means milk, skim milk, cream, reconstituted milk powder, reconstituted skim milk powder or any combination thereof that has been pasteurized by being held at a temperature of not less than 61.6°C for a period of not less than 30 minutes, or for a time and a temperature that is equivalent thereto in phosphatase destruction, as determined by official method MFO-3, Determination of Phosphatase Activity in Dairy Products, November 30, 1981; (matière première pasteurisée)
pickles and relishes
pickles and relishes means foods that meet the standard prescribed in section B.11.051; (cornichons et achards)
stored
stored means to have been kept or held at a temperature of 2°C or more for a period of 60 days or more from the date of the beginning of the manufacturing process; (entreposé)
whole
whole means of the original size and shape as manufactured. (entier)
(2) The word “process” may be used in the place of the word “processed” in the following common names: processed (naming the variety) cheese, processed (naming the variety) cheese with (naming the added ingredients), processed cheese food, processed cheese food with (naming the added ingredients), processed cheese spread, and processed cheese spread with (naming the added ingredients).
B.08.031 A cheese made from milk that is the normal lacteal secretion of the mammary gland of animals other than the cow, genus Bos, shall
(a) conform to all requirements in this Division applicable to the variety; and
(b) be labelled to show the source of the milk on the principal display panel.
B.08.032 (1) Each of the following foods for which a standard is prescribed, namely,
(a) (named variety) cheese,
(b) cheddar cheese,
(c) cream cheese,
(d) whey cheese,
(e) (named variety) whey cheese,
(f) cream cheese with (named added ingredients),
(g) cream cheese spread,
(h) cream cheese spread with (named added ingredients),
(i) processed (named variety) cheese,
(j) processed (named variety) cheese with (named added ingredients),
(k) processed cheese food,
(l) processed cheese food with (named added ingredients),
(m) processed cheese spread,
(n) processed cheese spread with (named added ingredients),
(o) cold-pack (named variety) cheese,
(p) cold-pack (named variety) cheese with (named added ingredients),
(q) cold-pack cheese food, and
(r) cold-pack cheese food with (named added ingredients),
shall be labelled to show on the principal display panel a statement of the percentage of milk fat in the food followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”, and the percentage of moisture in the food followed by the word “moisture” or “water”.
(2) Subject to subsection (3), no person shall make any direct or indirect reference on the label of a food referred to in subsection (1) to the milk fat content or moisture content of the food except as required by subsection (1).
(3) In addition to the statements referred to in subsection (1), a person may, on the label of a food referred to in that subsection, make a declaration of the fat content of the food, expressed in grams per serving of a stated size.
B.08.033 (1) [S]. (Naming the variety) Cheese, other than cheddar cheese, cream cheese, whey cheese, cream cheese with (named added ingredients), cream cheese spread, cream cheese spread with (named added ingredients), processed (named variety) cheese, processed (named variety) cheese with (named added ingredients), processed cheese food, processed cheese food with (named added ingredients), processed cheese spread, processed cheese spread with (named added ingredients), cold-pack (named variety) cheese, cold-pack (named variety) cheese with (named added ingredients), cold-pack cheese food, cold-pack cheese food with (named added ingredients), cottage cheese and creamed cottage cheese,
(a) shall
(i) be the product made by coagulating milk, milk products or a combination thereof with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey,
(ii) possess the physical, chemical and organoleptic properties typical for the variety,
(iii) where it is a cheese of variety named in the table to this section, contain no more than the maximum percentage of moisture shown in Column II thereof for that variety,
(iv) where it is a cheese of a variety named in Part I of the table to this section, contain no less than the minimum percentage of milk fat shown in Column III for that variety, and
(v) where it is cheese of a variety named in Part II of the table to this section, contain no more than the maximum percentage of milk fat shown in Column III for that variety; and
(b) may contain
(i) salt, seasonings, condiments and spices,
(ii) flavouring preparations other than cheese flavouring,
(iii) micro-organisms to aid further ripening,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin or turmeric,
(B) in an amount not exceeding 35 parts per million, beta-apo-8’-carotenal, ethyl beta-apo-8’-carotenoate or a combination thereof, and
(C) in an amount not exceeding 0.10 parts per million, brilliant blue FCF in feta cheese only,
(v) calcium chloride as a firming agent in an amount not exceeding 0.02 per cent of the milk and milk products used,
(vi) paraffin wax as a coating in an amount consistent with good manufacturing practice,
(vii) where potassium nitrate, sodium nitrate or a combination thereof are used for the purpose and in the manner described in subsection (2), residues of potassium nitrate, sodium nitrate or a combination thereof in an amount not exceeding 50 parts per million,
(viii) wood smoke as a preservative in an amount consistent with good manufacturing practice,
(ix) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid,
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively, or
(D) natamycin applied to the surface of the cheese in an amount that does not exceed 20 parts per million or, if the cheese is grated or shredded, 10 parts per million,
(x) in the case of grated or shredded cheese, calcium silicate, microcrystalline cellulose or cellulose, or a combination of them, as an anticaking agent, the total amount not to exceed 2.0 per cent, and
(xi) carbon dioxide as a pH adjusting agent in milk for cheese production, in an amount consistent with good manufacturing practice.
(2) Potassium nitrate, sodium nitrate or a combination thereof may be used as a preservative in cheese providing the following requirements are met:
(a) the amount of the salt or combination of salts does not exceed 200 parts per million of the milk and milk products used to make the cheese;
(b) the cheese in which the preservative is used is
(i) mold ripened cheese packed in a hermetically sealed container, or
(ii) ripened cheese
(A) that contains not more than 68 per cent moisture on a fat free basis, and
(B) during the manufacture of which the lactic acid fermentation and salting was completed more than 12 hours after coagulation of the curd by enzymes; and
(c) the salting is, in the case of the cheese described in subparagraph (b)(ii), applied externally as a dry salt or in the form of a brine.
(3) No person shall use an enzyme other than
(a) milk coagulating enzymes derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), Mucor pusillus Lindt or Aspergillus oryzae RET-1 (pBoel777), aminopeptidase derived from Lactococcus lactis, Chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), Chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), protease derived from Micrococcus caseolyticus, pepsin, rennet or bovine rennet, in the manufacture of any cheese to which subsection (1) applies;
(b) lipase and enzymes described in paragraph (a), in the manufacture of Asiago cheese, Blue cheese, Caciocavallo cheese, Feta cheese and Provolone cheese;
(c) a milk coagulating enzyme derived from Endothia parasitica and enzymes described in paragraph (a), in the manufacture of Emmentaler (Emmental, Swiss) cheese, Mozzarella (Scamorza) cheese and Part Skim Mozzarella (Part Skim Scamorza) cheese;
(d) lipase, a milk coagulating enzyme derived from Endothiaparasitica and enzymes described in paragraph (a), in the manufacture of Parmesan cheese and Romano cheese;
(e) protease derived from Aspergillus oryzae, in the manufacture of Colby cheese; and
(f) lysozyme derived from egg white.
(3.1) No person shall use an enzyme referred to in subsection (3) at a level of use above that consistent with good manufacturing practice.
(4) Where a flavouring preparation, other than a flavouring preparation that has been traditionally used in the variety, is added to a cheese as permitted in subsection (1), the words “with (naming the flavouring preparation)” shall be added to the common name on any label.
(5) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(6) Where a cheese is labelled as permitted in subsection (5), the word “smoked” shall be shown on the principal display panel.
TABLE
PART I
Column IColumn IIColumn IIIItemVariety of CheeseMaximum percentage of moistureMinimum percentage of milk fat1Asiago40.030.02Baby Edam47.021.03Baby Gouda45.026.04Blue47.027.05Butter (Butterkäse)46.027.06Bra36.026.07Brick42.029.08Brie54.023.09Caciocavallo45.024.010Camembert (Carré de l’est)56.022.011Canadian Style Brick42.029.012Canadian Style Munster46.027.013Colby42.029.014Danbo46.025.015Edam46.022.016Elbo46.025.017Emmentaler (Emmental, Swiss)40.027.018Esrom50.023.019Farmer’s44.027.020Feta55.022.021Fontina46.027.022Fynbo46.025.023Gouda43.028.024Gournay55.033.025Gruyère38.028.026Havarti50.023.027Jack50.025.028Kasseri44.025.029Limburger50.025.030Maribo43.026.031Montasio40.028.032Monterey (Monterey Jack)44.028.033Mozzarella (Scamorza)52.020.034Muenster (Munster)50.025.035Neufchâtel60.020.036Parmesan32.022.037Part Skim Mozzarella (Part Skim Scamorza)52.015.038Part Skim Pizza48.015.039Pizza48.020.040Provolone45.024.041Romano (Sardo)34.025.042St. Jorge40.027.043Saint-Paulin50.025.044Samsoë44.026.045Tilsiter (Tilsit)45.025.046Tybo46.025.0PART II
Column IColumn IIColumn IIIItemVariety of CheeseMaximum percentage of moistureMaximum percentage of milk fat1Harzkase (Harzer Käse, Mainzer Käse)55.03.02Skim Milk55.07.0B.08.034 (1) [S]. Cheddar Cheese
(a) shall
(i) be the product made by coagulating milk, milk products or a combination thereof with the aid of bacteria to form a curd and subjecting the curd to
(A) the cheddar process, or
(B) any process other than the cheddar process that produces a cheese having the same physical, chemical and organoleptic properties as those of cheese produced by the cheddar process, and
(ii) contain
(A) not more than 39 per cent moisture, and
(B) not less than 31 per cent milk fat; and
(b) may contain
(i) salt,
(ii) flavouring preparations other than cheese flavouring,
(iii) bacterial cultures to aid further ripening,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8’-carotenal, ethyl beta-apo-8’-carotenoate,
(v) calcium chloride as a firming agent in an amount not exceeding 0.02 per cent of the milk and milk products used,
(vi) wood smoke as a preservative in an amount consistent with good manufacturing practice,
(vii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or a combination thereof in an amount not exceeding 2,000 parts per million calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or a combination thereof in an amount not exceeding 3,000 parts per million calculated as sorbic acid,
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million calculated as propionic acid and sorbic acid respectively, or
(D) natamycin applied to the surface of the cheese in an amount that does not exceed 20 parts per million or, if the cheese is grated or shredded, 10 parts per million, and
(viii) in the case of grated or shredded cheddar cheese, calcium silicate, microcrystalline cellulose or cellulose, or a combination of them, as an anticaking agent, the total amount not to exceed 2.0 per cent.
(2) No person shall, in the manufacture of the cheddar cheese, use any enzyme other than
(a) lipase, pepsin, rennet, milk coagulating enzymes derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), Mucor pusillus Lindt or Aspergillus oryzae RET-1 (pBoel777), aminopeptidase derived from Lactococcus lactis, Chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A) or Chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105);
(b) protease derived from Aspergillus oryzae; and
(c) lysozyme derived from egg white.
(2.1) No person shall use an enzyme referred to in subsection (2) at a level of use above that consistent with good manufacturing practice.
(3) Where a flavouring preparation is added to a cheese as permitted in subsection (1), the words “with (naming the flavouring preparation)” shall be added to the common name in any label.
(4) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(5) Where a cheese is labelled as permitted in subsection (4), the word “smoked” shall be shown on the principal display panel.
B.08.035 (1) [S]. Cream Cheese
(a) shall
(i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, and
(ii) contain
(A) not more than 55 per cent moisture, and
(B) not less than 30 per cent milk fat; and
(b) may contain
(i) cream added to adjust the milk fat content,
(ii) salt,
(iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice,
(iv) the following emulsifying, gelling, stabilizing and thickening agents:
ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or any combination thereof in an amount not exceeding 0.5 per cent, and
(v) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) No person shall use any enzyme
(a) other than Chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), Chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin or rennet in the manufacture of cream cheese; and
(b) at a level of use above that consistent with good manufacturing practice.
B.08.036 (1) [S]. Whey Cheese or (naming the variety) Whey Cheese
(a) shall be the product made by coagulating whey or concentrated whey with the aid of heat to form a curd and shaping the curd; and
(b) may contain
(i) micro-organisms to aid further ripening,
(ii) added milk and milk products, and
(iii) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice.
(2) No person shall use, to aid coagulation of whey in the manufacture of whey cheese, a substance other than vinegar or sour whey.
B.08.037 (1) [S]. Cream Cheese with (naming the added ingredients)
(a) shall
(i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, and
(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cream cheese but not in amounts so large as to change the basic nature of the product:
(A) cheese other than cream cheese,
(B) seasonings, spices, flavouring preparations, condiments or chocolate,
(C) fruits, vegetables, pickles, relishes or nuts,
(D) prepared or preserved meat, or
(E) prepared or preserved fish, and
(iii) contain
(A) not more than 60 per cent moisture, and
(B) not less than 26 per cent milk fat; and
(b) may contain
(i) cream added to adjust the milk fat content,
(ii) salt,
(iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8’-carotenal, ethyl beta-apo-8’-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or any combination thereof in an amount not exceeding 0.5 per cent, and
(vi) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) No person shall use any enzyme
(a) other than Chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), Chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin or rennet in the manufacture of a product to which subsection (1) applies; and
(b) at a level of use above that consistent with good manufacturing practice.
B.08.038 (1) [S]. Cream Cheese Spread
(a) shall
(i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey, and
(ii) contain
(A) added milk and milk products,
(B) not less than 51 per cent cream cheese,
(C) not more than 60 per cent moisture, and
(D) not less than 24 per cent milk fat; and
(b) may contain
(i) cream added to adjust the milk fat content,
(ii) salt, vinegar and sweetening agents,
(iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
(A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, and
(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, and
(vii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) No person shall use any enzyme
(a) other than Chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), Chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin or rennet in the manufacture of a product to which subsection (1) applies; and
(b) at a level of use above that consistent with good manufacturing practice.
B.08.039 (1) [S]. Cream Cheese Spread with (naming the added ingredients)
(a) shall
(i) be the product made by coagulating cream with the aid of bacteria to form a curd and forming the curd into a homogeneous mass after draining the whey,
(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cream cheese spread but not in amounts so large as to change the basic nature of the product:
(A) cheese other than cream cheese,
(B) seasonings, spices, flavouring preparation, condiments or chocolate,
(C) fruits, vegetables, pickles, relishes or nuts,
(D) prepared or preserved meat, or
(E) prepared or preserved fish, and
(iii) contain
(A) added milk and milk products,
(B) not more than 60 per cent moisture, and
(C) not less than 24 per cent milk fat; and
(b) may contain
(i) cream added to adjust the milk fat content,
(ii) salt, vinegar and sweetening agents,
(iii) nitrogen to improve spreadability in an amount consistent with good manufacturing practice,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
(A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent, and
(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice, and
(vii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) No person shall use any enzyme
(a) other than Chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), Chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS 105), pepsin or rennet in the manufacture of a product to which subsection (1) applies; and
(b) at a level of use above that consistent with good manufacturing practice.
B.08.040 (1) [S]. Processed (naming the variety) Cheese
(a) shall
(i) subject to subparagraph (ii), be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat,
(ii) in the case of processed cheddar cheese, be the product made by comminuting and mixing one or more of the following:
(A) cheddar cheese,
(B) stirred curd cheese,
(C) granular curd cheese, or
(D) washed curd cheese
into a homogeneous mass with the aid of heat,
(iii) have, where it is made from
(A) one variety of cheese, in which the maximum amount of moisture permitted is less than 40 per cent, or
(B) two or more varieties of cheese, in which the average maximum amount of moisture permitted is less than 40 per cent,
a moisture content that does not exceed, by more than five per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than three per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be,
(iv) subject to subparagraph (v), have, where it is made from
(A) one variety of cheese, in which the maximum amount of moisture permitted is 40 per cent or more, or
(B) more than one variety of cheese, in which the average maximum amount of moisture permitted is 40 per cent or more,
a moisture content that does not exceed, by more than three per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than two per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be, and
(v) in the case of processed skim milk cheese, contain not more than
(A) 55 per cent moisture, and
(B) seven per cent milk fat; and
(b) may contain
(i) water added to adjust the moisture content,
(ii) added milk fat,
(iii) in the case of processed skim milk cheese, added skim milk powder, buttermilk powder and whey powder,
(iv) salt, vinegar and sweetening agents,
(v) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(vi) the following emulsifying, gelling, stabilizing and thickening agents:
(A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent,
(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,
(C) lecithin in an amount not exceeding 0.2 per cent, and
(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,
(vi.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,
(vii) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(viii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(ix) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.041 (1) [S]. Processed (naming the variety) Cheese with (naming the added ingredients)
(a) shall
(i) be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat,
(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed (named variety) cheese but not in amounts so large as to change the basic nature of the product:
(A) flavouring preparations other than such preparations that resemble the flavour of the varieties of cheese used in the product,
(B) seasonings, spices, condiments or chocolate,
(C) fruits, vegetables, pickles, relishes or nuts,
(D) prepared or preserved meat, or
(E) prepared or preserved fish,
(iii) have, where it is made from
(A) one variety of cheese, in which the maximum amount of moisture permitted is less than 40 per cent, or
(B) more than one variety of cheese, in which the average maximum amount of moisture permitted is less than 40 per cent,
a moisture content that does not exceed by more than five per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than three per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be, and
(iv) have, where it is made from
(A) one variety of cheese, in which the maximum amount of moisture permitted is 40 per cent or more, or
(B) more than one variety of cheese, in which the average maximum amount of moisture permitted is 40 per cent or more,
a moisture content that does not exceed, by more than three per cent, the amount referred to in clause (A) or (B), as the case may be, and a milk fat content that is not less, by more than two per cent, than the minimum milk fat content or average minimum milk fat content permitted for that variety or those varieties, as the case may be; and
(b) may contain
(i) water added to adjust moisture content,
(ii) added milk fat,
(iii) salt, vinegar and sweetening agents,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
(A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent,
(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,
(C) lecithin in an amount not exceeding 0.2 per cent, and
(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,
(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(viii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.041.1 (1) [S]. Processed Cheese Food
(a) shall
(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, and
(ii) contain
(A) added milk or milk products,
(B) not less than 51 per cent cheese,
(C) not more than 46 per cent moisture, and
(D) not less than 23 per cent milk fat; and
(b) may contain
(i) water added to adjust the moisture content,
(ii) added milk fat,
(iii) salt, vinegar and sweetening agents,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
(A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent,
(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,
(C) lecithin in an amount not exceeding 0.2 per cent, and
(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,
(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(viii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.041.2 (1) [S]. Processed Cheese Food with (naming the added ingredients)
(a) shall
(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat,
(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed cheese food but not in amounts so large as to change the basic nature of the product:
(A) seasonings, spices, flavouring preparations, condiments or chocolate,
(B) fruits, vegetables, pickles, relishes or nuts,
(C) prepared or preserved meat, or
(D) prepared or preserved fish, and
(iii) contain
(A) added milk or milk products,
(B) not more than 46 per cent moisture, and
(C) not less than 22 per cent milk fat; and
(b) may contain
(i) water added to adjust the moisture content,
(ii) added milk fat,
(iii) salt, vinegar and sweetening agents,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8’-carotenal, ethyl beta-apo-8’-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
(A) sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate) in an amount not exceeding 0.5 per cent,
(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,
(C) lecithin in an amount not exceeding 0.2 per cent, and
(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,
(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(viii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.041.3 (1) [S]. Processed Cheese Spread
(a) shall
(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat, and
(ii) contain
(A) added milk or milk products,
(B) not less than 51 per cent cheese,
(C) not more than 60 per cent moisture, and
(D) not less than 20 per cent milk fat;
(b) may contain
(i) water added to adjust the moisture content,
(ii) added milk fat,
(iii) salt, vinegar and sweetening agents,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8’-carotenal, ethyl beta-apo-8’-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
(A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,
(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,
(C) lecithin in an amount not exceeding 0.2 per cent, and
(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,
(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(viii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.041.4 (1) [S]. Processed Cheese Spread with (naming the added ingredients)
(a) shall
(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass with the aid of heat,
(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from processed cheese spread but not in amounts so large as to change the basic nature of the product:
(A) seasonings, spices, flavouring preparations, condiments or chocolate,
(B) fruits, vegetables, pickles, relishes or nuts,
(C) prepared or preserved meat, or
(D) prepared or preserved fish, and
(iii) contain
(A) added milk or milk products,
(B) not more than 60 per cent moisture, and
(C) not less than 20 per cent milk fat; and
(b) may contain
(i) water added to adjust the moisture content,
(ii) added milk fat,
(iii) salt, vinegar and sweetening agents,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
(A) ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,
(B) calcium phosphate dibasic, potassium phosphate dibasic, sodium acid pyrophosphate, sodium aluminum phosphate, sodium hexametaphosphate, sodium phosphate dibasic, sodium phosphate monobasic, sodium phosphate tribasic, sodium pyrophosphate tetrabasic, calcium citrate, potassium citrate, sodium citrate, sodium potassium tartrate, sodium tartrate, sodium gluconate or any combination thereof in an amount, when calculated as anhydrous salts, not exceeding 3.5 per cent in the case of phosphate salts and 4.0 per cent in total,
(C) lecithin in an amount not exceeding 0.2 per cent, and
(D) monoglycerides, mono- and diglycerides or any combination thereof in an amount not exceeding 0.5 per cent,
(v.1) calcium phosphate tribasic as an agent to improve colour, texture, consistency and spreadability, in an amount not exceeding 1 per cent,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(viii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.041.5 (1) [S]. Cold-Pack (naming the variety) Cheese
(a) shall
(i) subject to subparagraph (ii), be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat,
(ii) in the case of cold-pack cheddar cheese, be the product made by comminuting and mixing one or more of the following:
(A) cheddar cheese,
(B) stirred curd cheese,
(C) granular curd cheese, or
(D) washed curd cheese
into a homogeneous mass without the aid of heat,
(iii) contain, where it is made from
(A) one variety of cheese, not more moisture and not less milk fat than the maximum moisture content and minimum fat content permitted for that variety, or
(B) more than one variety of cheese, not more moisture and not less milk fat than the average maximum moisture content and the average minimum fat content permitted for those varieties; and
(b) may contain
(i) water added to adjust the moisture content,
(ii) added milk fat,
(iii) salt, vinegar and sweetening agents,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(v) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(vi) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(vii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.041.6 (1) [S]. Cold-Pack (naming the variety) Cheese with (naming the added ingredients)
(a) shall
(i) be the product made by comminuting and mixing the named variety or varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat,
(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cold-pack (named variety) cheese but not in amounts so large as to change the basic nature of the product:
(A) flavouring preparations other than such preparations that resemble the flavour of the varieties of cheese used in the product,
(B) seasonings, spices, condiments or chocolate,
(C) fruits, vegetables, pickles, relishes or nuts,
(D) prepared or preserved meat, or
(E) prepared or preserved fish, and
(iii) contain, where it is made from
(A) one variety of cheese, not more moisture and not less milk fat than the maximum moisture content and one per cent less than the minimum milk fat content permitted for that variety, or
(B) more than one variety of cheese, not more moisture and not less milk fat than the average maximum moisture content and one per cent less than the average minimum milk fat content permitted for those varieties; and
(b) may contain
(i) water added to adjust the moisture content,
(ii) added milk fat,
(iii) salt, vinegar and sweetening agents,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(viii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.041.7 (1) [S]. Cold-Pack Cheese Food
(a) shall
(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat,
(ii) contain
(A) added milk or milk products,
(B) not less than 51 per cent cheese,
(C) not more than 46 per cent moisture, and
(D) not less than 23 per cent milk fat; and
(b) may contain
(i) water added to adjust the moisture content,
(ii) added milk fat,
(iii) salt, vinegar and sweetening agents,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(viii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.041.8 (1) [S]. Cold-Pack Cheese Food with (naming the added ingredients)
(a) shall
(i) be the product made by comminuting and mixing one or more varieties of cheese, other than cream cheese, cottage cheese or whey cheese, into a homogeneous mass without the aid of heat,
(ii) contain the named added ingredients which shall be one or more of the following ingredients in amounts sufficient to differentiate the product from cold-pack cheese food but not in amounts so large as to change the basic nature of the product:
(A) seasonings, spices, flavouring preparations, condiments or chocolate,
(B) fruits, vegetables, pickles, relishes or nuts,
(C) prepared or preserved meat, or
(D) prepared or preserved fish, and
(iii) contain
(A) added milk or milk products,
(B) not more than 46 per cent moisture, and
(C) not less than 22 per cent milk fat; and
(b) may contain
(i) water added to adjust moisture content,
(ii) added milk fat,
(iii) sweetening agents, salt and vinegar,
(iv) one or more of the following colouring agents:
(A) in an amount consistent with good manufacturing practice, annatto, beta-carotene, chlorophyll, paprika, riboflavin, turmeric, and
(B) in an amount not exceeding 35 parts per million, either singly or in combination thereof, beta-apo-8′-carotenal, ethyl beta-apo-8′-carotenoate,
(v) the following emulsifying, gelling, stabilizing and thickening agents:
ammonium carrageenan, calcium carrageenan, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, Irish Moss Gelose, potassium carrageenan, propylene glycol alginate, sodium carboxymethyl cellulose (carboxymethyl cellulose, cellulose gum, sodium cellulose glycolate), sodium carrageenan, tragacanth gum, xanthan gum or a combination thereof in an amount not exceeding 0.5 per cent,
(vi) acetic acid, calcium carbonate, citric acid, lactic acid, malic acid, phosphoric acid, potassium bicarbonate, potassium carbonate, sodium bicarbonate, sodium carbonate and tartaric acid as pH adjusting agents in an amount consistent with good manufacturing practice,
(vii) wood smoke as a preservative in an amount consistent with good manufacturing practice, and
(viii) the following preservatives:
(A) propionic acid, calcium propionate, sodium propionate or any combination thereof in an amount not exceeding 2,000 parts per million, calculated as propionic acid,
(B) sorbic acid, calcium sorbate, potassium sorbate, sodium sorbate, or any combination thereof in an amount not exceeding 3,000 parts per million, calculated as sorbic acid, or
(C) any combination of the preservatives named in clauses (A) and (B) in an amount not exceeding 3,000 parts per million, calculated as propionic acid and sorbic acid respectively.
(2) Only a cheese to which wood smoke has been added as permitted in subsection (1) may be described by the term “smoked” on a label.
(3) Where a cheese is labelled as permitted in subsection (2), the word “smoked” shall be shown on the principal display panel.
B.08.042 No manufacturer shall sell whole cheese that is not made from a pasteurized source unless the date of the beginning of the manufacturing process is
(a) marked or branded thereon within three days thereof; or
(b) marked on the label at the time of packaging, if the cheese is such that, because of its texture, consistency, or physical structure, such date cannot be effectively branded or marked on the cheese.
B.08.043 No manufacturer shall sell any cheese that is not made from a pasteurized source if it has been cut into smaller portions, unless
(a) it has been duly stored; or
(b) each portion of cut cheese is marked, branded or labelled with the date of the beginning of the manufacturing process.
B.08.044 (1) Subject to subsection (2), no person shall sell cheese, including cheese curd, that is not made from a pasteurized source unless it has been stored.
(2) Cheese, including cheese curd, that is not made from a pasteurized source may be used as an ingredient in any food providing such food is manufactured or processed so as to pasteurize the cheese in the manner described in the definition pasteurized source in section B.08.030(1).
B.08.045 Notwithstanding B.08.044, cheese that has not been manufactured from a pasteurized source and has not been stored but is marked or branded with the date of the beginning of the manufacturing process, may be sold to
(a) a wholesaler;
(b) a jobber; or
(c) in quantities of not less than 900 pounds, to a retailer.
B.08.046 No person shall sell any whole cheese that has not been made from a pasteurized source unless there is stamped thereon the date of the beginning of the manufacturing process.
B.08.047 Every manufacturer, wholesaler, or jobber who sells cheese not made from a pasteurized source and which has not been stored shall keep a record of
(a) the registered number of the cheese factory,
(b) the date of manufacture of the cheese,
(c) the vat number or vat numbers,
(d) the name and address of the person to whom the cheese is sold, and
(e) the weight sold from each vat,
for each lot of cheese sold.
B.08.048 (1) Subject to section B.08.054, no person shall sell cheese, including cheese curd, made from a pasteurized source if the cheese contains more than
(a) 100 Escherichia coli, or
(b) 100 Staphylococcus aureus
per gram, as determined by official method MFO-14, Microbiological Examination of Cheese, November 30, 1983.
(2) No person shall sell cheese, made from an unpasteurized source if the cheese contains more than
(a) 500 Escherichia coli, or
(b) 1,000 Staphylococcus aureus
per gram, as determined by official method MFO-14, Microbiological Examination of Cheese, November 30, 1983.
B.08.049 [S]. Whey
(a) shall be the product remaining after the curd has been removed from milk in the process of making cheese; and
(b) may contain
(i) catalase, in the case of liquid whey that has been treated with hydrogen peroxide,
(ii) lactase,
(iii) hydrogen peroxide, in the case of liquid whey destined for the manufacture of dried whey products, and
(iv) benzoyl peroxide and calcium phosphate tribasic, as a carrier of the benzoyl peroxide, in the case of liquid whey destined for the manufacture of dried whey products other than those for use in infant formula.
B.08.050 [Repealed, SOR/95-281, s. 1]
B.08.051 [S]. Cottage Cheese
(a) shall be the product, in the form of discrete curd particles, prepared from skim milk, evaporated skim milk or skim milk powder and harmless acid-producing bacterial cultures;
(b) shall contain not more than 80 per cent moisture;
(c) may contain not more than 0.5 per cent stabilizing agent; and
(d) may contain
(i) milk,
(ii) cream,
(iii) milk powder,
(iv) rennet,
(v) milk coagulating enzymes derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), Mucor pusillus Lindt or Aspergillus oryzae RET-1 (pBoel777), in an amount consistent with good manufacturing practice,
(vi) Chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), in an amount consistent with good manufacturing practice,
(vi.1) Chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), in an amount consistent with good manufacturing practice,
(vii) salt,
(viii) calcium chloride,
(ix) added lactose,
(x) pH adjusting agents,
(xi) relishes,
(xii) fruits,
(xiii) vegetables, and
(xiv) carbon dioxide.
B.08.052 [S]. Creamed Cottage Cheese shall be cottage cheese containing cream or a mixture of cream with milk or skim milk, or both, in such quantity that the final product shall contain
(a) not less than four per cent milk fat; and
(b) not more than 80 per cent moisture and may contain emulsifying, gelling, stabilizing and thickening agents.
B.08.053 All dairy products used in the preparation of cottage cheese shall be from a pasteurized source.
B.08.054 No person shall sell cottage cheese or creamed cottage cheese that contains more than 10 coliform bacteria per gram, as determined by official method MFO-4, Microbiological Examination of Cottage Cheese, November 30, 1981.
Butter
B.08.056 [S]. Butter
(a) shall
(i) be the food prepared in accordance with good manufacturing practices from milk or milk products, and
(ii) contain not less than 80 per cent milk fat; and
(b) may contain
(i) milk solids,
(ii) bacterial culture,
(iii) salt, and
(iv) food colour.
B.08.057 [S]. Whey Butter shall be butter made from whey cream.
Ice Cream
B.08.061 [S]. Ice Cream Mix
(a) shall be the unfrozen, pasteurized combination of cream, milk or other milk products, sweetened with sugar, liquid sugar, invert sugar, honey, dextrose, glucose, corn syrup, corn syrup solids or any combination of such sweeteners;
(b) may contain
(i) egg,
(ii) a flavouring preparation,
(iii) cocoa or chocolate syrup,
(iv) a food colour,
(v) pH adjusting agents,
(vi) microcrystalline cellulose or a stabilizing agent or both in an amount that will not exceed 0.5 per cent of the ice cream made from the mix,
(vii) a sequestering agent,
(viii) salt, and
(ix) not more than one per cent added edible casein or edible caseinates; and
(c) shall contain not less than
(i) 36 per cent solids, and
(ii) 10 per cent milk fat or, where cocoa or chocolate syrup has been added, eight per cent milk fat.
B.08.062 [S]. Ice Cream
(a) shall be the frozen food obtained by freezing an ice cream mix, with or without the incorporation of air;
(b) may contain cocoa or chocolate syrup, fruit, nuts or confections;
(c) shall contain not less than
(i) 36 per cent solids,
(ii) 10 per cent milk fat, or, where cocoa or chocolate syrup, fruit, nuts, or confections have been added, eight per cent milk fat, and
(iii) 180 grams of solids per litre of which amount not less than 50 grams shall be milk fat, or, where cocoa or chocolate syrup, fruit, nuts or confections have been added, 180 grams of solids per litre of which amount not less than 40 grams shall be milk fat; and
(d) shall contain not more than
(i) 100,000 bacteria per gram, and
(ii) 10 coliform organisms per gram,
as determined by official method MFO-2, Microbiological Examination of Ice Cream or Ice Milk, November 30, 1981.
Sherbet
B.08.063 [S]. Sherbet
(a) shall be the frozen food, other than ice cream or ice milk, made from a milk product;
(b) may contain
(i) water,
(ii) a sweetening agent,
(iii) fruit or fruit juice,
(iv) citric or tartaric acid,
(v) a flavouring preparation,
(vi) a food colour,
(vii) not more than 0.75 per cent stabilizing agent,
(viii) a sequestering agent,
(ix) lactose,
(x) not more than 0.5 per cent microcrystalline cellulose, and
(xi) not more than one per cent added edible casein or edible caseinates; and
(c) shall contain
(i) not more than five per cent milk solids, including milk fat, and
(ii) not less than 0.35 per cent acid determined by titration and expressed as lactic acid.
Ice Milk
B.08.071 [S]. Ice Milk Mix
(a) shall be the unfrozen, pasteurized combination of cream, milk or other milk products, sweetened with sugar, liquid sugar, invert sugar, honey, dextrose, glucose, corn syrup, corn syrup solids or any combination of such sweeteners;
(b) may contain
(i) egg,
(ii) a flavouring preparation,
(iii) cocoa or chocolate syrup,
(iv) a food colour,
(v) a pH adjusting agent,
(vi) a stabilizing agent, in an amount that will not result in more than 0.5 per cent stabilizing agent in the ice milk,
(vii) a sequestering agent,
(viii) added lactose, and
(ix) not more than 1.5 per cent microcrystalline cellulose,
(x) salt, and
(xi) not more than one per cent added edible casein or edible caseinates; and
(c) shall contain
(i) not less than 33 per cent solids, and
(ii) not less than three per cent and not more than five per cent milk fat.
B.08.072 [S]. Ice Milk
(a) shall be the frozen food obtained by freezing an ice milk mix, with or without the incorporation of air;
(b) may contain cocoa or chocolate syrup, fruit, nuts or confections;
(c) shall contain
(i) not less than 33 per cent solids,
(ii) not less than three per cent and not more than five per cent milk fat, and
(iii) not less than 160 grams of solids per litre of which amount not less than 14 grams shall be milk fat; and
(d) shall contain not more than
(i) 100,000 bacteria per gram, and
(ii) 10 coliform organisms per gram,
as determined by official method MFO-2, Microbiological Examination of Ice Cream or Ice Milk, November 30, 1981.
B.08.073 [Repealed, SOR/92-626, s. 13]
B.08.074 (1) The percentage of milk fat contained in
(a) yogurt,
(b) cottage cheese, and
(c) creamed cottage cheese,
shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.
(2) In addition to the statement referred to in subsection (1), a person may, on the label of a food referred to in subsection (1), make a declaration of the fat content of the food, expressed in grams per serving of stated size.
Cream
B.08.075 [S]. Cream
(a) shall be the fatty liquid prepared from milk by separating the milk constituents in such a manner as to increase the milk fat content; and
(b) may contain
(i) a pH adjusting agent,
(ii) a stabilizing agent, and
(iii) in the case of cream for whipping that has been heat-treated above 100°C, the following ingredients and food additives:
(A) skim milk powder in an amount not exceeding 0.25 per cent,
(B) glucose solids in an amount not exceeding 0.1 per cent,
(C) calcium sulphate in an amount not exceeding 0.005 per cent,
(D) xanthan gum in an amount not exceeding 0.02 per cent, and
(E) microcrystalline cellulose in an amount not exceeding 0.2 per cent.
B.08.076 (1) The percentage of milk fat contained in canned cream shall be shown on the principal display panel followed by the words “milk fat” or the abbreviation “B.F.” or “M.F.”.
(2) In addition to the statement referred to in subsection (1), a person may, on the label of canned cream, make a declaration of the fat content of the cream, expressed in grams per serving of stated size.
B.08.077 [S]. Sour Cream
(a) shall be the product prepared by the souring of pasteurized cream with acid-producing bacterial culture and shall contain not less than 14 per cent milk fat; and
(b) may contain
(i) milk solids,
(ii) whey solids,
(iii) buttermilk,
(iv) starch in an amount not exceeding one per cent,
(v) salt,
(vi) rennet as a food enzyme in an amount consistent with good manufacturing practice,
(vii) the following emulsifying, gelling, stabilizing and thickening agents:
(A) algin, carob bean gum (locust bean gum), carrageenan, gelatin, guar gum, pectin or propylene glycol alginate or any combination thereof in an amount not exceeding 0.5 per cent,
(B) monoglycerides, mono- and diglycerides, or any combination thereof, in an amount not exceeding 0.3 per cent, and
(C) sodium phosphate dibasic in an amount not exceeding 0.05 per cent,
(viii) sodium citrate as a flavour precursor in an amount not exceeding 0.1 per cent,
(ix) milk coagulating enzymes derived from Rhizomucor miehei (Cooney and Emerson) (previous name: Mucor miehei (Cooney and Emerson)), Mucor pusillus Lindt or Aspergillus oryzae RET-1 (pBoel777), in an amount consistent with good manufacturing practice,
(x) Chymosin A derived from Escherichia coli K-12, GE81 (pPFZ87A), in an amount consistent with good manufacturing practice, and
(xi) Chymosin B derived from Aspergillus niger var. awamori, GCC0349 (pGAMpR) or from Kluyveromyces marxianus var. lactis, DS1182 (pKS105), in an amount consistent with good manufacturing practice.
DIVISION 9
Fats And Oils
B.09.001 [S]. Vegetable fats and oils shall be fats and oils obtained entirely from the botanical source after which they are named, shall be dry and sweet in flavour and odour and, with the exception of olive oil, may contain emulsifying agents, Class IV preservatives, an antifoaming agent, and B-carotene in a quantity sufficient to replace that lost during processing, if such an addition is declared on the label.
B.09.002 [S]. Animal fats and oils shall be fats and oils obtained entirely from animals healthy at the time of slaughter, shall be dry and sweet in flavour and odour and may contain
(a) with the exception of milk fat and suet, Class IV preservatives; and
(b) with the exception of lard, milk fat and suet, an antifoaming agent.
B.09.003 [S]. Olive Oil or Sweet Oil
(a) shall be the oil obtained from the fruit of the olive tree (Olea europaea L);
(b) shall have a fatty acid content that is
(i) not less than 56.0 and not more than 83.0 per cent oleic acid,
(ii) not less than 7.5 and not more than 20.0 per cent palmitic acid,
(iii) not less than 3.5 and not more than 20.0 per cent linoleic acid,
(iv) not less than 0.5 and not more than 3.5 per cent stearic acid,
(v) not less than 0.3 and not more than 3.5 per cent palmitoleic acid,
(vi) not more than 1.5 per cent linolenic acid, and
(vii) not more than 0.05 per cent myristic acid, calculated as methyl esters;
(c) shall not contain more than minute amounts of arachidic acid, behenic acid, gadoleic acid or lignoceric acid;
(d) shall have
(i) a relative density of not less than 0.910 and not more than 0.916, calculated with the oil at 20°C and water at 20°C (20°C/water at 20°C),
(ii) a refractive index of not less than 1.4677 and not more than 1.4705, calculated using the sodium D-line as the light source and with the oil at 20°C (nD20°C),
(iii) an iodine value of not less than 75 and not more than 94, calculated using the Wijs test,
(iv) a saponification value of not less than 184 and not more than 196, expressed as milligrams of potassium hydroxide per gram of oil,
(v) an acid value of not more than 6.6 milligrams potassium hydroxide per gram of oil,
(vi) a free acidity of not more than 3.3 per cent expressed as oleic acid,
(vii) a peroxide value of not more than 20 milliequivalents peroxide oxygen per kilogram of oil,
(viii) an unsaponifiable matter content of not more than 15 grams per kilogram, and
(ix) a Bellier index of not more than 17;
(e) shall show negative results when tested for semi-siccative oil, olive-residue oil, cotton-seed oil, tea-seed oil or sesame seed oil; and
(f) notwithstanding section B.09.001, may contain alpha-tocopherol in a quantity sufficient to replace that lost during refining, if such an addition is declared on the label.
B.09.004 [S]. Cotton Seed Oil
(a) shall be the oil of seeds of cultivated Gossypium spp.;
(b) shall have
(i) a relative density (20°C/water at 20°C) of not less than 0.918 and not more than 0.926,
(ii) a refractive index (nD40°C) of not less than 1.458 and not more than 1.466,
(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 189 and not more than 198,
(iv) an iodine value (Wijs) of not less than 99 and not more than 119,
(v) an unsaponifiable matter content of not more than 15 grams per kilogram,
(vi) a positive Halphen test,
(vii) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and
(viii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil; and
(c) may contain oxystearin.
B.09.005 [S]. Cocoa Butter shall be the fat from cocoa nibs, obtained either before or after roasting, or cocoa liquor, and shall have
(a) a refractive index (40°C) of not less than 1.453 and not more than 1.458;
(b) a saponification value of not less than 188 and not more than 202;
(c) an iodine value (Hanus) of not less than 32 and not more than 41; and
(d) an acid value of not more than five.
B.09.006 [S]. Corn Oil or Maize Oil
(a) shall be the oil of the germ or embryo of Zea mays L.; and
(b) shall have
(i) a relative density of (20°C/water at 20°C) of not less than 0.917 and not more than 0.925,
(ii) a refractive index (nD40°C) of not less than 1.465 and not more than 1.468,
(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 187 and not more than 195,
(iv) an iodine value (Wijs) of not less than 103 and not more than 128,
(v) an unsaponifiable matter content of not more than 28 grams per kilogram,
(vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and
(vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil.
B.09.007 [S]. Peanut Oil or Arachis Oil
(a) shall be the oil of the seeds of Arachis hypogaea L.;
(b) shall have
(i) a relative density of (20°C/water at 20°C) of not less than 0.914 and not more than 0.917,
(ii) a refractive index (nD40°C) of not less than 1.460 and not more than 1.465,
(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 187 and not more than 196,
(iv) an iodine value (Wijs) of not less than 80 and not more than 106,
(v) an unsaponifiable matter content of not more than 10 grams per kilogram,
(vi) an arachidic and higher fatty acids content of not less than 48 grams per kilogram,
(vii) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and
(viii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil; and
(c) not contain oxystearin.
B.09.008 [S]. Soybean Oil, Soya Bean Oil, Soja Oil or Soya Oil
(a) shall be the oil of the seeds of Glycine max (L.) Merr.;
(b) shall have
(i) a relative density of (20°C/water at 20°C) of not less than 0.919 and not more than 0.925,
(ii) a refractive index (nD40°C) of not less than 1.466 and not more than 1.470,
(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 189 and not more than 195,
(iv) an iodine value (Wijs) of not less than 120 and not more than 143,
(v) an unsaponifiable matter content of not more than 15 grams per kilogram,
(vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and
(vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil; and
(c) may contain oxystearin.
B.09.009 [S]. Sunflowerseed Oil or Sunflower Oil
(a) shall be the oil of the seeds of Helianthus annuus L.; and
(b) shall have
(i) a relative density of (20°C/water at 20°C) of not less than 0.918 and not more than 0.923,
(ii) a refractive index (nD40°C) of not less than 1.467 and not more than 1.469,
(iii) an iodine value (Wijs) of not less than 110 and not more than 143,
(iv) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 188 and not more than 194,
(v) an unsaponifiable matter content of not more than 15 grams per kilogram,
(vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and
(vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil.
B.09.009A [S]. Safflowerseed Oil or Safflower Oil
(a) shall be the oil of the seeds of Carthamus tinctorius L.;
(b) shall have
(i) a relative density of (20°C/water at 20°C) of not less than 0.922 and not more than 0.927,
(ii) a refractive index (nD40°C) of not less than 1.467 and not more than 1.470,
(iii) a saponification value (milligrams potassium hydroxide per gram of oil) of not less than 186 and not more than 198,
(iv) an iodine value (Wijs) of not less than 135 and not more than 150,
(v) an unsaponifiable matter content of not more than 15 grams per kilogram,
(vi) an acid value of not more than 0.6 milligram potassium hydroxide per gram of oil, and
(vii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of oil.
B.09.010 Notwithstanding item 1 of the table to paragraph B.01.010(3)(b), where a vegetable fat or oil is an ingredient of any cooking oil, salad oil or table oil, the fat or oil shall be shown in the list of ingredients by its common name.
B.09.011 [S]. Shortening, other than butter or lard, shall be the semi-solid food prepared from fats, oils or a combination of fats and oils, may be processed by hydrogenation and may contain
(a) Class IV preservatives,
(b) an antifoaming agent,
(c) stearyl monoglyceridyl citrate,
(d) monoglycerides or a combination of monoglycerides and diglycerides of fat forming fatty acids, the weight of the monoglycerides being not more than 10 per cent and the total weight of monoglycerides and diglycerides being not more than 20 per cent of the weight of the shortening,
(e) lactylated monoglycerides, or a combination of lactylated monoglycerides and diglycerides of fat forming fatty acids, the total weight being not more than eight per cent of the weight of the shortening, and
(f) sorbitan tristearate,
except that the total weight of the ingredients permitted under paragraphs (d) and (e) shall not be greater than 20 per cent of the weight of the shortening.
B.09.012 [Repealed, SOR/97-148, s. 2]
B.09.013 [S]. Lard
(a) shall be the rendered fat from hogs;
(b) shall have
(i) a relative density of not less than 0.894 and not more than 0.906, calculated with the lard at 40°C and water at 20°C (40°C/water at 20°C),
(ii) a refractive index of not less than 1.448 and not more than 1.461, calculated using the sodium D-line as the light source and with the lard at 40°C (nD40°C),
(iii) a titre of not less than 32°C and not more than 45°C,
(iv) a saponification value of not less than 192 and not more than 203, expressed as milligrams potassium hydroxide per gram of fat,
(v) an iodine value of not less than 45 and not more than 70, calculated using the Wijs test,
(vi) an unsaponifiable matter content of not more than 12 grams per kilogram,
(vii) an acid value of not more than 2.5 milligrams potassium hydroxide per gram of fat, and
(viii) a peroxide value of not more than 16 milliequivalents peroxide oxygen per kilogram of fat; and
(c) may contain
(i) lard stearine or hydrogenated lard,
(ii) a Class IV preservative, and
(iii) not more than one per cent of substances resulting from the rendering process, other than fatty acids and fat.
B.09.014 [S]. Leaf Lard shall be lard that has been rendered at a moderately high temperature from the internal fat of the abdomen of the hog, excluding that adhering to the intestines, and shall have an iodine value (Hanus) of not more than 65.
B.09.015 [S]. Suet
(a) shall be the fat taken from the region of the kidney or loin or caul fat of a beef carcass;
(b) shall have
(i) a relative density of not less than 0.893 and not more than 0.898, calculated with the suet at 40°C and water at 20°C (40°C/water at 20°C),
(ii) a refractive index of not less than 1.448 and not more than 1.460, calculated using the sodium D-line as the light source and with the suet at 40°C (nD40°C),
(iii) a titre of not less than 42.5°C and not more than 47°C,
(iv) a saponification value of not less than 190 and not more than 200, expressed as milligrams of potassium hydroxide per gram of fat,
(v) an iodine value of not less than 32 and not more than 47, calculated using the Wijs test,
(vi) an unsaponifiable matter content of not more than 10 grams per kilogram,
(vii) an acid value of not more than 2.0 milligrams potassium hydroxide per gram of fat, and
(viii) a peroxide value of not more than 10 milliequivalents peroxide oxygen per kilogram of fat; and
(c) where sold in comminuted form, shall contain not more than three per cent cereal and one per cent salt.
B.09.016 [S]. Margarine
(a) shall be a plastic or fluid emulsion of water in fats, oil or fats and oil that are not derived from milk and may have been subjected to hydrogenation;
(b) shall contain
(i) not less than 80 per cent fat, oil or fat and oil calculated as fat, and
(ii) notwithstanding section D.01.009, not less than
(A) 3,300 International Units of vitamin A, and
(B) 530 International Units of vitamin D
per 100 grams; and
(c) may contain
(i) skim milk powder, buttermilk powder or liquid buttermilk,
(ii) whey solids or modified whey solids,
(iii) protein,
(iv) water,
(v) vitamin E, if added in such an amount as will result in the finished product containing not less than 0.6 International Unit of alphatocopherol per gram of linoleic acid present in the margarine,
(vi) a flavouring agent,
(vii) a sweetening agent,
(viii) potassium chloride and sodium chloride,
(ix) the following colouring agents: annatto, ß-apo-8′- carotenal, canthaxanthin, carotene, ethyl ß-apo-8′-carotenoate and turmeric, as set out in Table III to section B.16.100,
(x) the following emulsifying agents: lecithin, mono- and di-glycerides, mono-glycerides and sorbitan tristearate, as set out in Table IV to section B.16.100,
(xi) the following pH adjusting agents: citric acid, lactic acid, potassium bicarbonate, sodium bicarbonate, potassium carbonate, sodium carbonate, sodium citrate, sodium lactate, potassium citrate, potassium hydroxide, sodium hydroxide, potassium lactate, sodium potassium tartrate and tartaric acid, as set out in Table X to section B.16.100,
(xii) the following preservatives: ascorbyl palmitate, ascorbyl stearate, benzoic acid, butylated hydroxyanisole, butylated hydroxytoluene, calcium sorbate, monoglyceride citrate, monoisopropyl citrate, potassium benzoate, potassium sorbate, propyl gallate, sodium benzoate, sodium sorbate and sorbic acid, as set out in Table XI to section B.16.100, and
(xiii) the following sequestering agents: calcium disodium ethylenediaminetetraacetate and stearyl citrate, as set out in Table XII to section B.16.100.
B.09.017 [S]. Calorie-Reduced Margarine
(a) shall conform to the standard for margarine except it shall contain not more than
(i) 40 per cent fat, oil or fat and oil calculated as fat, and
(ii) 50 per cent of the calories that would be normally present in the product if it were not calorie-reduced;
(b) subject to paragraph (c), may contain, either singly or in combination, in an amount not exceeding 0.5 per cent,
(i) acacia gum,
(ii) agar,
(iii) algin,
(iv) carob bean gum,
(v) carrageenan,
(vi) furcelleran,
(vii) gellan gum,
(viii) guar gum,
(ix) karaya gum,
(x) propylene glycol alginate,
(xi) tragacanth gum, and
(xii) xanthan gum;
(c) may
(i) if it contains none of the ingredients mentioned in paragraph (b), contain polyglycerol esters of fatty acids in an amount not exceeding 0.2 per cent, or
(ii) if it contains a combination of one or more of the ingredients mentioned in paragraph (b) and polyglycerol esters of fatty acids, contain such esters in an amount not exceeding 0.2 per cent, provided that the total combination of such esters and ingredients does not exceed an amount of 0.5 per cent;
(d) notwithstanding subparagraph B.09.016(c)(x), may contain lecithin in an amount not exceeding 0.5 per cent; and
(e) may contain
(i) vegetable starch,
(ii) modified vegetable starch, and
(iii) maltodextrin.
B.09.020 and B.09.021 [Repealed, SOR/88-559, s. 20]
B.09.022 No person shall sell cooking oil, margarine, salad oil, simulated dairy product, shortening or food that resembles margarine or shortening, if the product contains more than five per cent C22 Monoenoic Fatty Acids calculated as a proportion of the total fatty acids contained in the product.
DIVISION 10
Flavouring Preparations
B.10.003 [S]. (naming the flavour) Extract or (naming the flavour) Essence shall be a solution in ethyl alcohol, glycerol, propylene glycol or any combination of these, of sapid or odorous principles, or both, derived from the plant after which the flavouring extract or essence is named, and may contain water, a sweetening agent, food colour and a Class II preservative or Class IV preservative.
B.10.004 [S]. Artificial (naming the flavour) Extract, Artificial (naming the flavour) Essence, Imitation (naming the flavour) Extract or Imitation (naming the flavour) Essence shall be a flavouring extract or essence except that the flavouring principles shall be derived in whole, or in part, from sources other than the aromatic plant after which it is named, and if such extract or essence is defined in these Regulations, the flavouring strength of the artificial or imitation extract or essence shall be not less than that of the extract or essence.
B.10.005 [S]. (naming the flavour) Flavour
(a) shall be a preparation, other than a flavouring preparation described in section B.10.003, of sapid or odorous principles, or both, derived from the aromatic plant after which the flavour is named;
(b) may contain a sweetening agent, food colour, Class II preservative, thaumatin, Class IV preservative or emulsifying agent; and
(c) may have added to it the following liquids only:
(i) water,
(ii) any of, or any combination of, the following: benzyl alcohol; 1, 3-butylene glycol, ethyl acetate, ethyl alcohol, glycerol, glyceryl diacetate, glyceryl triacetate, glyceryl tributyrate, isopropyl alcohol, monoglycerides and diglycerides; 1, 2-propylene glycol or triethylcitrate,
(iii) edible vegetable oil, and
(iv) brominated vegetable oil, sucrose acetate isobutyrate or mixtures thereof, when such flavour is used in citrus-flavoured or spruce-flavoured beverages.
B.10.006 [S]. Artificial (naming the flavour) Flavour or Imitation (naming the flavour) Flavour shall be a flavour except that the flavouring principles may be derived in whole or in part from sources other than the aromatic plant after which it is named, and if such flavour is defined in these Regulations, the flavouring strength of the artificial or imitation flavour shall be not less than that of the flavour.
B.10.007 [S]. Notwithstanding sections B.10.003 and B.10.005, a (naming the fruit) Extract Naturally Fortified, (naming the fruit) Essence Naturally Fortified or (naming the fruit) Flavour Naturally Fortified shall be an extract, essence or flavour derived from the named fruit to which other natural extractives have been added and 51 per cent of the flavouring strength shall be derived from the named fruit.
B.10.008 On any label of or in any advertisement for an artificial or imitation flavouring preparation, the word “artificial”, or “imitation” shall be an integral part of the name of such flavouring preparation and shall be set out in identical type and identically displayed with such name.
B.10.009 [S]. Almond Essence, Almond Extract or Almond Flavour shall be the essence, extract or flavour derived from the kernels of the bitter almond, apricot or peach and shall contain not less than one per cent by volume of hydrocyanic acid-free volatile oil obtained therefrom.
B.10.010 [S]. Anise Essence, Anise Extract or Anise Flavour shall be the essence, extract or flavour derived from natural or terpeneless oil of anise and shall correspond in flavouring strength to an alcoholic solution containing not less than three per cent by volume of oil of anise, the volatile oil obtained from the fruit of Pimpinella anisum L. or Illicium verum Hook.
B.10.011 [S]. Celery Seed Essence, Celery Seed Extract or Celery Seed Flavour shall be the essence, extract or flavour derived from celery seed, or oil of celery seed, or terpeneless oil of celery seed and shall correspond in flavouring strength to an alcoholic solution containing not less than 0.3 per cent by volume of volatile oil of celery seed.
B.10.012 [S]. Cassia Essence, Cassia Extract, Cassia Cinnamon Essence, Cassia Cinnamon Extract, Cassia Flavour or Cassia Cinnamon Flavour shall be the essence, extract or flavour derived from natural or terpeneless oil, obtained from leaves and twigs of Cinnamomum cassia L. containing not less than 80 per cent cinnamic aldehyde, and shall correspond in flavouring strength to an alcoholic solution containing not less than two per cent by volume of volatile oil of cassia cinnamon.
B.10.013 [S]. Ceylon Cinnamon Essence, Ceylon Cinnamon Extract or Ceylon Cinnamon Flavour shall be the essence, extract or flavour derived from the volatile oil obtained from the bark of Cinnamomum zeylanicum Nees, and shall contain
(a) not less than two per cent by volume of oil of Ceylon cinnamon;
(b) not less than 65 per cent cinnamic aldehyde; and
(c) not more than 10 per cent eugenol.
B.10.014 [S]. Clove Essence, Clove Extract or Clove Flavour shall be the essence, extract or flavour derived from the volatile oil obtained from clove buds, and shall contain not less than two per cent by volume of oil of clove.
B.10.015 [S]. Ginger Essence, Ginger Extract or Ginger Flavour shall be the essence, extract or flavour derived from ginger and shall contain in 100 millilitres the alcohol-soluble matter from not less than 20 grams of ginger.
B.10.016 [S]. Lemon Essence, Lemon Extract or Lemon Flavour shall be the essence, extract or flavour prepared from natural or terpeneless oil of lemon or from lemon peel and shall contain not less than 0.2 per cent citral derived from oil of lemon.
B.10.017 [S]. Nutmeg Essence, Nutmeg Extract or Nutmeg Flavour shall be the essence, extract or flavour prepared from natural or terpeneless oil of nutmeg and shall correspond in flavouring strength to an alcoholic solution containing not less than two per cent by volume of oil of nutmeg.
B.10.018 [S]. Orange Essence, Orange Extract or Orange Flavour shall be the essence, extract or flavour prepared from sweet orange peel, oil of sweet orange or terpeneless oil of sweet orange, and shall correspond in flavouring strength to an alcoholic solution containing five per cent by volume of oil of sweet orange, the volatile oil obtained from the fresh peel of Citrus aurantium L., that shall have an optical rotation, at a temperature of 25°C, of not less than +95° using a tube 100 millimetres in length.
B.10.019 [S]. Peppermint Essence, Peppermint Extract or Peppermint Flavour shall be the essence, extract or flavour prepared from peppermint or oil of peppermint, obtained from the leaves and flowering tops of Mentha piperita L., or of Mentha arvensis De.C., var. piperascens Holmes, and shall correspond in flavouring strength to an alcoholic solution of not less than three per cent by volume of oil of peppermint, containing not less than 50 per cent free and combined menthol.
B.10.020 [S]. Rose Essence, Rose Extract or Rose Flavour shall be the essence, extract or flavour prepared from the volatile oil obtained from the petals of Rosa damascena Mill., R. centajolia L., or R. moschata Herrm, and shall contain not less than 0.4 per cent by volume of attar of rose.
B.10.021 [S]. Savory Essence, Savory Extract or Savory Flavour shall be the essence, extract or flavour prepared from savory or oil of savory and shall contain not less than 0.35 per cent by volume oil of savory.
B.10.022 [S]. Spearmint Essence, Spearmint Extract or Spearmint Flavour shall be the essence, extract or flavour prepared from spearmint or from oil of spearmint, obtained from the leaves and flowering tops of Mentha spicata L. and shall contain not less than three per cent by volume of oil of spearmint.
B.10.023 [S]. Sweet Basil Essence, Sweet Basil Extract or Sweet Basil Flavour shall be the essence, extract or flavour prepared from sweet basil or from oil of sweet basil, obtained from the leaves and tops of Ocymum basilicum L. and shall contain not less than 0.1 per cent by volume of oil of sweet basil.
B.10.024 [S]. Sweet Marjoram Essence, Sweet Marjoram Extract, Marjoram Essence, Marjoram Extract, Sweet Marjoram Flavour or Marjoram Flavour shall be the essence, extract or flavour prepared from marjoram or from oil of marjoram and shall contain not less than one per cent by volume of oil of marjoram.
B.10.025 [S]. Thyme Essence, Thyme Extract or Thyme Flavour shall be the essence, extract or flavour prepared from thyme or from oil of thyme and shall contain not less than 0.2 per cent by volume of oil of thyme.
B.10.026 [S]. Vanilla Extract, Vanilla Essence or Vanilla Flavour
(a) shall be the essence, extract or flavour prepared from the vanilla bean, the dried, cured fruit of Vanilla planifolia, Andrews, or Vanilla tahitensia, J. W. Moore;
(b) shall contain in 100 ml, regardless of the method of extraction, at least the quantity of soluble substances in their natural proportions that are extractable, according to official method FO-17, Extraction of Soluble Substances from Vanilla Beans, dated September 15, 1989, from
(i) not less than 10 g of vanilla beans, where the beans contain 25 per cent or less moisture, and
(ii) not less than 7.5 g of vanilla beans on the moisture-free basis, where the beans contain more than 25 per cent moisture; and
(c) notwithstanding sections B.10.003 and B.10.005, shall not contain added colour.
B.10.027 [S]. Wintergreen Essence, Wintergreen Extract or Wintergreen Flavour shall be the essence, extract or flavour prepared from oil of wintergreen, the volatile oil distilled from the leaves of Gaultheria procumbens L. or from Betula lenta L. and shall contain not less than three per cent by volume of oil of wintergreen.
DIVISION 11
Fruits, Vegetables, Their Products And Substitutes
B.11.001 In this Division,
acid ingredient
acid ingredient means
(a) citric, malic or tartaric acid,
(b) lemon or lime juice, or
(c) vinegar; (ingrédient acide)
fruit juice
fruit juice means the unfermented liquid expressed from sound ripe fresh fruit, and includes any such liquid that is heat treated and chilled; (jus de fruit)
sweetening ingredient
sweetening ingredient means sugar, invert sugar, honey, dextrose, glucose or glucose solids or any combination thereof in dry or liquid form. (ingrédient édulcorant)
B.11.001.1 No person shall sell any fresh fruit or vegetable that is intended to be consumed raw, except grapes, if sulphurous acid or any salt thereof has been added thereto.
Vegetables
B.11.002 [S]. Canned (naming the vegetable)
(a) shall be the product obtained by heat processing the named fresh vegetable after it has been properly prepared;
(b) shall be packed in hermetically sealed containers;
(c) may contain
(i) a sweetening ingredient,
(ii) salt,
(iii) water, and
(iv) a firming agent; and
(d) may contain
(i) in the case of canned green beans and canned wax beans, pieces of green peppers, red peppers and tomato in an amount not exceeding 15 per cent of the final product, and dill seasonings and vinegar,
(ii) in the case of canned peas, garnishes composed of one or more of lettuce, onions, carrots, and pieces of green or red peppers in an amount not exceeding 15 per cent of the total drained vegetable ingredient, aromatic herbs, spices and seasonings, stock or juice of vegetables and aromatic herbs, calcium hydroxide in an amount not exceeding 0.01 per cent of the final product and magnesium hydroxide in an amount not exceeding 0.05 per cent of the final product,
(iii) in the case of
(A) canned asparagus, acetic acid, citric acid, malic acid and tartaric acid at levels consistent with good manufacturing practice,
(B) canned white asparagus, acetic acid, citric acid, malic acid, tartaric acid and ascorbic acid at levels consistent with good manufacturing practice, and
(C) canned chili peppers, citric acid at a level consistent with good manufacturing practice,
(iv) in the case of asparagus packed in glass containers or fully lined (lacquered) cans, stannous chloride in an amount not exceeding 25 parts per million, calculated as tin,
(v) in the case of canned artichokes, canned bean sprouts and canned onions, citric acid at levels consistent with good manufacturing practice, to be used as a pH adjusting agent,
(vi) in the case of canned ripe lima beans (butter beans) and canned pinto beans, calcium disodium ethylenediaminetetraacetate in an amount not exceeding 130 parts per million,
(vi.1) in the case of canned fava beans, calcium disodium ethylenediaminetetraacetate in an amount not exceeding 365 parts per million,
(vii) in the case of canned red kidney beans, canned chick peas (garbanzo beans) and canned black-eye peas, disodium ethylenediaminetetraacetate in an amount not exceeding 150 parts per million, and
(viii) in the case of canned asparagus, canned green beans, canned wax beans and canned peas
(A) butter or other edible animal or vegetable fats or oils, but if butter is added it shall be not less than three per cent of the final product,
(B) natural or enzymatically or physically modified starches when used with butter or other edible animal or vegetable fats and oils,
(C) acacia gum, algin, carrageenan, furcelleran, guar gum and propylene glycol alginate used with butter or other edible animal or vegetable fats or oils in an amount not exceeding one per cent, singly or in any combination, of the final product, and
(D) characterizing sauces, seasonings or flavouring agents if it is included in the common name of the product.
B.11.003 [S]. Canned Mushrooms
(a) shall be the product obtained by heat-processing properly prepared mushrooms of the cultivated type;
(b) shall be packed in hermetically sealed containers; and
(c) may contain ascorbic acid, citric acid and salt.
B.11.003A [S]. Frozen Mushrooms
(a) shall be the product obtained by freezing properly prepared mushrooms of the cultivated type; and
(b) may contain sodium metabisulphite, sodium phosphate dibasic, sodium sulphate and salt.
B.11.004 [S]. Frozen (naming the vegetable) shall be the product obtained by freezing the named fresh vegetable after it has been properly prepared and subjected to a blanching treatment and may contain added salt.
B.11.005 [S]. Tomatoes or Canned Tomatoes
(a) shall be the product made by heat processing properly prepared fresh ripe tomatoes;
(b) may contain
(i) a sweetening ingredient in dry form,
(ii) salt,
(iii) a firming agent,
(iv) citric acid, and
(v) spice or other seasoning; and
(c) shall contain not less than 50 per cent drained tomato solids, as determined by official method FO-18, Determination of Drained Tomato Solids, October 15, 1981.
B.11.007 [S]. Tomato Juice shall be the unconcentrated, pasteurized liquid containing a substantial portion of fine tomato pulp extracted from sound, ripe, whole tomatoes from which all stems and objectionable portions have been removed by any method that does not add water to the liquid and may contain salt and a sweetening ingredient in dry form.
B.11.009 [S]. Tomato Paste shall be the product made by evaporating a portion of the water from tomatoes or sound tomato trimmings, may contain salt and Class II preservatives and shall contain not less than 20 per cent tomato solids, as determined by official method FO-19, Determination of Tomato Solids, October 15, 1981.
B.11.010 [S]. Concentrated Tomato Paste shall be tomato paste containing not less than 30 per cent tomato solids, as determined by official method FO-19, Determination of Tomato Solids, October 15, 1981.
B.11.011 [S]. Tomato Pulp shall be the heat processed product made from whole, ripe tomatoes or sound tomato trimmings concentrated to yield a product with a specific gravity of not less than 1.050 (20°C/20°C) and may contain salt and a Class II preservative.
B.11.012 [S]. Tomato Puree shall be the heat processed product made from whole, ripe tomatoes, with the skins and seeds removed, concentrated to yield a product with a specific gravity of not less than 1.050 (20°C/20°C) and may contain salt and a Class II preservative.
B.11.014 [S]. Tomato Catsup, Catsup or products whose common names are variants of the word Catsup
(a) shall be the heat processed product made from the juice of red-ripe tomatoes or sound tomato trimmings from which skins and seeds have been removed;
(b) shall contain
(i) vinegar,
(ii) salt,
(iii) seasoning, and
(iv) a sweetening ingredient; and
(c) may contain
(i) a Class II preservative, and
(ii) food colour.
B.11.015 [Repealed, SOR/97-151, s. 19]
B.11.016 No person shall sell canned tomatoes, tomato juice or vegetable juice that contains mould filaments in more than 25 per cent of the microscopic fields, when examined by official method MFO-5, Examination of Canned Tomatoes, Tomato Juice and Vegetable Juice, Tomato Puree, Tomato Paste, Tomato Pulp and Tomato Catsup for Mould Filaments, November 30, 1981.
B.11.017 No person shall sell tomato puree, tomato paste, tomato pulp or tomato catsup that contains mould filaments in more than 50 per cent of the microscopic fields, when examined by official method MFO-5, Examination of Canned Tomatoes, Tomato Juice and Vegetable Juice, Tomato Puree, Tomato Paste, Tomato Pulp and Tomato Catsup for Mould Filaments, November 30, 1981.
B.11.025 No person shall sell potatoes, sweet potatoes or yams that have been artificially coloured.
B.11.040 [S]. Beans with Pork or Beans and Pork shall be the food prepared from dried beans and pork, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 60 per cent drained solids, as determined by official method FO-20, Determination of Drained Solids of Beans with Pork or Beans and Pork and Beans or Vegetarian Beans, October 15, 1981.
B.11.041 [S]. Beans or Vegetarian Beans shall be the food prepared from dried beans, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 60 per cent drained solids, as determined by official method FO-20, Determination of Drained Solids of Beans with Pork or Beans and Pork and Beans or Vegetarian Beans, October 15, 1981.
B.11.050 [S]. Olives shall be the plain or stuffed fruit of the olive tree, and may contain
(a) vinegar;
(b) salt;
(c) a sweetening ingredient;
(d) spices;
(e) seasonings;
(f) lactic acid;
(g) sorbic acid or its potassium or sodium salt;
(h) calcium chloride;
(i) citric acid; and
(j) in the case of ripe olives, ferrous gluconate.
B.11.051 [S]. Pickles and relishes shall be the product prepared from vegetables or fruits with salt and vinegar, and may contain
(a) spices;
(b) seasonings;
(c) sugar, invert sugar, dextrose or glucose, in dry or liquid form;
(d) food colour;
(e) a Class II preservative;
(f) a firming agent;
(g) polyoxyethylene (20) sorbitan monooleate in an amount not exceeding 0.05 per cent;
(h) lactic acid;
(i) vegetable oils; and
(j) in the case of relishes and mustard pickles, a thickening agent.
Fruits
B.11.101 [S]. Canned (naming the fruit)
(a) shall be the product prepared by heat processing the named fresh fruit after it has been properly prepared;
(b) shall be packed in hermetically sealed containers; and
(c) may contain
(i) a sweetening ingredient,
(ii) water,
(iii) fruit juice, fruit juice from concentrate, concentrated fruit juice or any combination thereof,
(iv) in the case of canned pears, citric acid, malic acid, L-tartaric or lactic acid at a level sufficient to maintain pH 4.2 to 4.5, lemon juice, spices, spice oils, mint and a flavouring preparation other than that which simulates the flavour of canned pears,
(v) in the case of canned apples, a firming agent,
(vi) in the case of canned applesauce, citric acid and malic acid at a level sufficient to maintain pH 4.2 to 4.5, ascorbic acid and isoascorbic acid provided the total does not exceed 150 parts per million, spices, salt and a flavouring preparation other than that which simulates the flavour of canned applesauce,
(vii) in the case of canned grapefruit, citric acid at a level sufficient to maintain pH 4.2 to 4.5, lemon juice, calcium chloride and calcium lactate provided the total calcium content, whether naturally present or added, does not exceed 0.035 per cent, spices and a flavouring preparation other than that which simulates the flavour of canned grapefruit,
(viii) in the case of canned mandarin oranges, citric acid at a level sufficient to maintain pH 4.2 to 4.5,
(ix) in the case of canned peaches, L-ascorbic acid at a level not to exceed 550 parts per million, spices, peach pits and peach kernels intended for flavour development and a flavouring preparation other than that which simulates the flavour of canned peaches,
(x) in the case of canned pineapple, citric acid at a level sufficient to maintain pH 4.2 to 4.5, spices, spice oils, mint, dimethylpolysiloxane not to exceed 10 parts per million when pineapple juice is used as a packing medium and a flavouring preparation other than that which simulates the flavour of canned pineapple,
(xi) in the case of canned plums, a flavouring preparation other than that which simulates the flavour of canned plums, and
(xii) in the case of canned strawberries, citric acid, lactic acid, malic acid or L-tartaric acid at a level sufficient to maintain pH 4.2 to 4.5.
B.11.102 [S]. Frozen (naming the fruit) shall be the product obtained by freezing the named fresh fruit after it has been properly prepared and may contain
(a) a sweetening ingredient;
(b) water;
(c) fruit juice, fruit juice from concentrate, concentrated fruit juice or any combination thereof;
(d) ascorbic acid, citric acid, erythorbic acid or malic acid to prevent discolouration; and
(e) in the case of frozen sliced apples,
(i) a firming agent, and
(ii) sulphurous acid.
B.11.103 and B.11.104 [Repealed, SOR/79-252, s. 1]
B.11.105 [Repealed, SOR/97-151, s. 20]
Fruit Juices
B.11.120 [S]. (Naming the fruit) Juice
(a) shall be the juice obtained from the named fruit; and
(b) may contain a sweetening ingredient in dry form, a Class II preservative, amylase, cellulase and pectinase.
B.11.121 Notwithstanding section B.11.120, the fruit juice prepared from any fruit named in any of sections B.11.123 to B.11.128A shall conform to the standard prescribed for that fruit juice in that section.
B.11.123 [S]. Apple Juice
(a) shall be the fruit juice obtained from apples;
(b) may contain a Class II preservative, vitamin C, amylase, cellulase and pectinase;
(c) shall have a specific gravity of not less than 1.041 and not more than 1.065 (20°C/20°C); and
(d) shall contain, in 100 millilitres measured at a temperature of 20°C, not less than 0.24 gram and not more than 0.60 gram of ash of which not less than 50 per cent shall be potassium carbonate.
B.11.124 [S]. Grape Juice
(a) shall be the fruit juice obtained from grapes;
(b) shall have a specific gravity of not less than 1.040 and not more than 1.124 (20°C/20°C);
(c) shall contain, before the addition of a sweetening ingredient, in 100 millilitres measured at a temperature of 20°C,
(i) not less than 0.20 gram and not more than 0.55 gram of ash, and
(ii) not less than 0.015 gram and not more than 0.070 gram of phosphoric acid calculated as phosphorous pentoxide; and
(d) may contain a pH-adjusting agent, a sweetening ingredient in dry form, a Class II preservative, vitamin C, amylase, cellulase and pectinase.
B.11.125 [S]. Grapefruit Juice
(a) shall be fruit juice obtained from clean, sound, mature grapefruit;
(b) shall
(i) contain not less than 1.15 milliequivalents of free amino acid per 100 millilitres, as determined by official method FO-21, Determination of Amino Acids in Grapefruit Juice and Orange Juice, October 15, 1981,
(ii) contain not less than 70 milligrams of potassium per 100 millilitres, as determined by official method FO-22, Determination of Potassium in Grapefruit Juice and Orange Juice, October 15, 1981, and
(iii) have an absorbance value for total polyphenolics of not less than 0.310, as determined by official method FO-23, Determination of Absorbance Value for Total Polyphenolics in Grapefruit Juice and Orange Juice, October 15, 1981;
(c) shall, before the addition of sugar, invert sugar, dextrose or glucose solids,
(i) have a Brix reading of not less than 9.3°, as determined by official method FO-24, Determination of Brix Reading for Grapefruit Juice and Orange Juice, October 15, 1981, and
(ii) contain not less than 0.7 per cent and not more than 2.1 per cent of acid by weight calculated as anhydrous citric acid, as determined by official method FO-25, Determination of Acid in Grapefruit Juice or Orange Juice, October 15, 1981; and
(d) may contain sugar, invert sugar, dextrose in dry form, glucose solids, a Class II preservative, amylase, cellulase and pectinase.
B.11.126 [S]. Lemon Juice
(a) shall be the fruit juice obtained from lemons;
(b) shall contain, before the addition of a sweetening ingredient, in 100 millilitres measured at a temperature of 20°C, not less than
(i) 8.0 grams of soluble solids, as determined by official method FO-26, Determination of Soluble Solids in Lemon Juice, Lime Juice or Lime Fruit Juice, October 15, 1981, and
(ii) 5.0 grams of acid calculated as anhydrous citric acid, as determined by official method FO-27, Determination of Acid in Lemon Juice, Lime Juice, or Lime Fruit Juice, October 15, 1981;
(c) may contain stannous chloride; and
(d) may contain a sweetening ingredient in a dry form, a Class II preservative, amylase, cellulase and pectinase.
B.11.127 [S]. Lime Juice or Lime Fruit Juice
(a) shall be the fruit juice obtained from limes;
(b) shall have
(i) a specific gravity of not less than 1.030 and not more than 1.040 (20°C/20°C),
(ii) its optical rotation between +0.5 and -1.5 degrees Ventzke, determined at a temperature of 20°C, using a tube 200 millimetres in length;
(c) shall contain, before the addition of a sweetening ingredient, in 100 millilitres measured at a temperature of 20°C, not less than
(i) 8.0 grams of soluble solids, as determined by official method FO-26, Determination of Soluble Solids in Lemon Juice, Lime Juice or Lime Fruit Juice, October 15, 1981, and
(ii) 5.5 grams of acid calculated as anhydrous citric acid, as determined by official method FO-27, Determination of Acid in Lemon Juice, Lime Juice or Lime Fruit Juice, October 15, 1981;
(d) may contain stannous chloride; and
(e) may contain a sweetening ingredient in a dry form, a Class II preservative, amylase, cellulase and pectinase.
B.11.128 [S]. Orange Juice
(a) shall be fruit juice obtained from clean, sound, mature oranges;
(b) shall
(i) contain not less than 1.20 milliequivalents of free amino acids per 100 millilitres, as determined by official method FO-21, Determination of Amino Acids in Grapefruit Juice and Orange Juice, October 15, 1981,
(ii) contain not less than 115 milligrams of potassium per 100 millilitres, as determined by official method FO-22, Determination of Potassium in Grapefruit Juice and Orange Juice, October 15, 1981, and
(iii) have an absorbance value for total polyphenolics of not less than 0.380, as determined by official method FO-23, Determination of Absorbance Value for Total Polyphenolics in Grapefruit Juice and Orange Juice, October 15, 1981;
(c) shall, before the addition of sugar, invert sugar, dextrose or glucose solids,
(i) have a Brix reading of not less than 9.7°, as determined by official method FO-24, Determination of Brix Reading for Grapefruit Juice and Orange Juice, October 15, 1981, and
(ii) contain not less than 0.5 per cent and not more than 1.8 per cent of acid by weight calculated as anhydrous citric acid, as determined by official method FO-25, Determination of Acid in Grapefruit Juice or Orange Juice, October 15, 1981;
(d) may contain orange essences, orange oils and orange pulp adjusted in accordance with good manufacturing practice; and
(e) may contain sugar, invert sugar, dextrose in dry form, glucose solids, a Class II preservative, amylase, cellulase and pectinase.
B.11.128A [S]. Pineapple Juice
(a) shall be the fruit juice obtained from pineapple; and
(b) may contain a sweetening ingredient in dry form, a Class II preservative, vitamin C, amylase, cellulase, pectinase and an antifoaming agent.
B.11.129 [S]. Carbonated (naming the fruit) Juice or Sparkling (naming the fruit) Juice shall be the named fruit juice impregnated with carbon dioxide under pressure.
B.11.130 [S]. (1) Concentrated (naming the fruit) juice
(a) shall be fruit juice that is concentrated to at least one half of its original volume by the removal of water;
(b) may contain
(i) vitamin C,
(ii) food colour,
(iii) stannous chloride,
(iv) a sweetening ingredient, and
(v) a class II preservative; and
(c) may have added to it, for the purpose of adjustment in accordance with good manufacturing practice, all or any of the following, namely,
(i) essence, oil and pulp from the named fruit, and
(ii) water.
(2) Subparagraphs (1)(b)(i), (ii), (iii) and (v) do not apply in respect of frozen concentrated orange juice.
B.11.131 [S]. (Naming the fruits) Juice shall be a mixture of fruit juices each of which meets the standard prescribed for that fruit juice in this Division.
B.11.132 [S]. Apple and (naming the fruit) Juice
(a) shall be a mixture of apple juice and another fruit juice, each of which meets the standard, if any, prescribed for that fruit juice in this Division; and
(b) may contain added vitamin C.
B.11.133 [S]. Reconstituted (naming the fruit) Juice or (naming the fruit) Juice from Concentrate
(a) shall be fruit juice that has been prepared by the addition of water to fruit juice of the same name from which water has been removed;
(b) may contain juice of the same name, a sweetening ingredient, and natural pulp, oils and esters of the named fruit;
(c) shall conform to the standards for the named fruit juices as prescribed in this Division; and
(d) may contain, in the case of reconstituted lemon or lime juice, not more than 10 parts per million dimethylpolysiloxane.
B.11.134 [S]. Apricot Nectar, Peach Nectar or Pear Nectar
(a) shall be the unfermented but fermentable pulpy product, intended for direct consumption, obtained by blending the total edible part of sound and ripe apricots, peaches and pears, as the case may be, concentrated or unconcentrated with water and, subject to subparagraph (e)(i), a sweetening ingredient;
(b) shall contain
(i) in the case of peach nectar and pear nectar, not less than 40 per cent by weight of the fruit or the equivalent derived from the concentrated fruit, and
(ii) in the case of apricot nectar, not less than 35 per cent by weight of the fruit or the equivalent derived from the concentrated fruit;
(c) shall contain not less than 13 per cent soluble solids by weight expressed as °Brix on the International Sucrose Scales and calculated by refractometer at 20°C and uncorrected for acidity;
(d) shall not contain more than 3 g/kg (3000 ppm) of ethanol and 10 mg/kg (10 ppm) of hydroxy methyl furfural; and
(e) may contain
(i) honey if no other sweetening ingredient is employed,
(ii) citric acid and malic acid at levels consistent with good manufacturing practice,
(iii) lemon juice, and
(iv) vitamin C.
Fruit Flavoured Drinks
B.11.150 No person shall label, package, sell or advertise a fruit flavoured drink in a manner that is likely to create an impression that the fruit flavoured drink contains vitamins or has any other nutritional value commonly associated with any fruit juice unless the following requirements are met:
(a) it is sold as a substitute for fruit juice or as a breakfast drink;
(b) it is not carbonated;
(c) it is not represented to be or is not commonly known as
(i) a soft drink, or
(ii) a thirst-quenching or refreshment drink; and
(d) notwithstanding sections D.01.009, D.01.011 and D.02.009,
(i) it contains vitamin C in an amount not less than 24 milligrams and not more than 48 milligrams, and
(ii) it contains
(A) where folic acid has been added, an amount of folic acid of not less than 40 micrograms and not more than 80 micrograms,
(B) where thiamine has been added, an amount of thiamine of not less than 0.08 milligram and not more than 0.11 milligram,
(C) where iron has been added, an amount of iron of not less than 0.56 milligram and not more than 0.80 milligram, or
(D) where potassium has been added, an amount of potassium of not less than 100 milligrams and not more than 200 milligrams,
per 100 millilitres when the drink is ready to serve.
B.11.151 No person shall label, package, sell or advertise a base, concentrate or mix that is used for making a fruit flavoured drink in a manner that is likely to create an impression that the drink made therefrom will contain vitamins or have any other nutritional value commonly associated with fruit juice unless the following requirements are met:
(a) the base, concentrate or mix
(i) is sold for the purpose of making a breakfast drink or a substitute for fruit juice,
(ii) is not represented to be or is not commonly known as a product that is used for making a soft drink or a thirst-quenching or refreshment drink; and
(b) where a drink is made therefrom as directed, the drink meets the requirements described in paragraph B.11.150(d).
Jams
B.11.201 [S]. (Naming the fruit) Jam
(a) shall be the product obtained by processing fruit, fruit pulp, or canned fruit, by boiling to a suitable consistency with water and a sweetening ingredient;
(b) shall contain not less than
(i) 45 per cent of the named fruit, and
(ii) 66 per cent water soluble solids as estimated by the refractometer;
(c) may contain
(i) such amount of added pectin, pectinous preparation, or acid ingredient as reasonably compensates for any deficiency in the natural pectin content or acidity of the named fruit,
(ii) a Class II preservative,
(iii) a pH adjusting agent, and
(iv) an antifoaming agent; and
(d) shall not contain apple or rhubarb.
B.11.202 [S]. (Naming the fruit) Jam with Pectin
(a) shall be the product obtained by processing fruit, fruit pulp, or canned fruit by boiling to a suitable consistency with water and a sweetening ingredient;
(b) shall contain
(i) not less than 27 per cent of the named fruit,
(ii) not less than 66 per cent water soluble solids as estimated by the refractometer, and
(iii) pectin or pectinous preparations;
(c) may contain
(i) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the named fruit,
(ii) food colour,
(iii) a Class II preservative,
(iv) a pH adjusting agent, and
(v) an antifoaming agent; and
(d) shall not contain apple or rhubarb.
B.11.203 [S]. Apple (or Rhubarb) and (naming the fruit) Jam
(a) shall be the product obtained by processing fruit, fruit pulp or canned fruit by boiling to a suitable consistency with water and a sweetening ingredient;
(b) shall contain not less than
(i) 12.5 per cent of the named fruit, except that where the named fruit is strawberry it shall contain not less than 15 per cent strawberries,
(ii) 20 per cent apple or rhubarb pulp, and
(iii) 66 per cent water soluble solids as estimated by the refractometer; and
(c) may contain
(i) pectin or pectinous preparation,
(ii) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the fruit used in its preparation,
(iii) food colour,
(iv) a Class II preservative,
(v) a pH adjusting agent, and
(vi) an antifoaming agent.
B.11.204 Where a jam for which a standard is prescribed in section B.11.203 contains added pectin or pectinous preparation, a statement to the effect that pectin or pectinous preparation has been added shall be shown on the principal display panel.
Marmalade
B.11.220 [S]. (Naming the citrus fruit) Marmalade shall be the food of jelly-like consistency made from any combination of peel, pulp or juice of the named citrus fruit by boiling with water and a sweetening ingredient and shall contain not less than 65 per cent water soluble solids as estimated by the refractometer and may contain
(a) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the named citrus fruit;
(b) a pH adjusting agent; and
(c) an antifoaming agent.
B.11.221 [S]. (Naming the citrus fruit) Marmalade with Pectin
(a) shall be the food of jelly-like consistency made from any combination of peel, pulp or juice of the named citrus fruit by boiling with water and a sweetening ingredient;
(b) shall contain
(i) not less than 27 per cent of any combination of peel, pulp or juice of the named citrus fruit,
(ii) not less than 65 per cent water soluble solids as estimated by the refractometer, and
(iii) pectin or pectinous preparation; and
(c) may contain
(i) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the citrus fruit used in its preparation,
(ii) a Class II preservative,
(iii) a pH adjusting agent, and
(iv) an antifoaming agent.
B.11.222 [S]. Pineapple Marmalade or Fig Marmalade
(a) shall be the food of jelly-like consistency made from the pulp of juice of the named fruit by boiling with water and a sweetening ingredient;
(b) shall contain not less than
(i) 45 per cent of the named fruit, and
(ii) 65 per cent water soluble solids, as estimated by the refractometer;
(c) may contain such amounts of added pectin, pectinous preparation or acid ingredient as reasonably compensates for any deficiency in the natural pectin content or acidity of the named fruit;
(d) a pH adjusting agent; and
(e) an antifoaming agent.
B.11.223 [S]. Pineapple Marmalade with Pectin or Fig Marmalade with Pectin
(a) shall be the food of jelly-like consistency made from the pulp and juice of the named fruit by boiling with water and a sweetening ingredient;
(b) shall contain
(i) not less than 27 per cent of the named fruit,
(ii) not less than 65 per cent water soluble solids as estimated by the refractometer, and
(iii) pectin or pectinous preparation; and
(c) may contain
(i) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the named fruit,
(ii) food colour,
(iii) a Class II preservative,
(iv) a pH adjusting agent, and
(v) an antifoaming agent.
B.11.224 [S]. (Naming the fruit) Preserve (Conserve) shall be the food made by processing fruit other than apple or rhubarb with a sweetening ingredient and shall contain not less than
(a) 45 parts by weight of the named fruit for each 55 parts by weight, on the dry basis, of a sweetening ingredient; and
(b) 60 per cent water-soluble solids, as estimated by the refractometer.
Jelly
B.11.240 [S]. (Naming the fruit) Jelly shall be the gelatinous food, free of seeds and pulp, made from the named fruit, the juice of the named fruit or a concentrate of the juice of the named fruit, which has been boiled with water and a sweetening ingredient, shall contain not less than 62 per cent water soluble solids as estimated by the refractometer and may contain
(a) such amount of added pectin, pectinous preparation or acid ingredient as reasonably compensates for any deficiency of the natural pectin content or acidity of the named fruit;
(b) a pH adjusting agent; and
(c) an antifoaming agent.
B.11.241 [S]. (Naming the fruit) Jelly with Pectin
(a) shall be the gelatinous food, free of seeds and pulp, made from the named fruit, the juice of the named fruit or a concentrate of the juice of the named fruit, which has been boiled with water and a sweetening ingredient;
(b) shall contain
(i) not less than the equivalent of 32 per cent juice of the named fruit,
(ii) not less than 62 per cent water soluble solids, as estimated by the refractometer, and
(iii) pectin or pectinous preparation; and
(c) may contain
(i) such amount of acid ingredient as reasonably compensates for any deficiency in the natural acidity of the named fruit,
(ii) juice of another fruit,
(iii) a gelling agent,
(iv) food colour,
(v) a Class II preservative,
(vi) a pH adjusting agent, and
(vii) an antifoaming agent.
B.11.242 The standards prescribed in these Regulations for jam and jelly do not apply to cranberry sauce, jellied cranberry, cranberry jelly, mint jelly and jellied mint.
Mince Meat
B.11.250 [S]. Mince, Mince Meat or Fruit Mince
(a) shall be the food prepared from
(i) fruit or dried fruit,
(ii) suet,
(iii) salt,
(iv) spices, and
(v) a sweetening agent; and
(b) may contain
(i) vinegar,
(ii) fresh, concentrated or fermented fruit juice,
(iii) spiritous liquor,
(iv) nuts,
(v) cooked meat,
(vi) a Class II preservative,
(vii) a thickening agent,
(viii) citric acid, and
(ix) caramel.
Boiled Cider
B.11.260 [S]. Boiled Cider shall be the liquid expressed from whole apples, apple cores, apple trimmings or apple culls and concentrated by boiling.
DIVISION 12
Prepackaged Water And Ice
B.12.001 [S]. Water represented as mineral water or spring water,
(a) shall be potable water obtained from an underground source but not obtained from a public community water supply;
(b) shall not contain any coliform bacteria, as determined by official method MFO-9, Microbiological Examination of Mineral Water, November 30, 1981;
(c) shall not have its composition modified through the use of any chemicals; and
(d) notwithstanding paragraph (c), may contain
(i) added carbon dioxide,
(ii) added fluoride, if the total fluoride ion content thereof does not exceed one part per million, and
(iii) added ozone.
B.12.002 The principal display panel of the label on a container of water represented as mineral water or spring water shall carry a statement
(a) of the geographical location of the underground source from which it is obtained;
(b) of the total dissolved mineral salt content expressed in parts per million;
(c) of the total fluoride ion content expressed in parts per million; and
(d) of any addition of fluoride or ozone thereto.
B.12.003 Where carbon dioxide has been added to water represented as mineral water or spring water, the word “carbonated” (“gazéifiée”) shall appear on the principal display panel of the label on the container thereof, as the first designation in the common name of the water when the added carbon dioxide
(a) did not originate from decarbonation of the water upon emergence from the underground source; or
(b) is present in a quantity greater than was present originally in the water.
B.12.004 No person shall sell water in sealed containers, other than water represented as mineral water or spring water, if it contains
(a) any coliform bacteria, as determined by official method MFO-15, Microbiological Examination of Water in Sealed Containers (Excluding Mineral and Spring Water) and of Prepackaged Ice, November 30, 1981;
(b) more than 100 total aerobic bacteria per millilitre, as determined by official method MFO-15, Microbiological Examination of Water in Sealed Containers (Excluding Mineral and Spring Water) and of Prepackaged Ice, November 30, 1981;
(c) naturally occurring fluoride ion in an amount that exceeds its naturally occurring amount; or
(d) added fluoride in such an amount that the total amount therein of added and naturally occurring fluoride ion exceeds one part per million.
B.12.005 (1) No person shall sell prepackaged ice if it contains
(a) any coliform bacteria, as determined by official method MFO-15, Microbiological Examination of Water in Sealed Containers (Excluding Mineral and Spring Water) and of Prepackaged Ice, November 30, 1981;
(b) naturally occurring fluoride ion in an amount that exceeds its naturally occurring amount; or
(c) added fluoride in such an amount that the total amount therein of added and naturally occurring fluoride ion exceeds one part per million.
(2) No person shall manufacture prepackaged ice for sale if the water from which it is made contains
(a) any coliform bacteria, as determined by official method MFO-15, Microbiological Examination of Water in Sealed Containers (Excluding Mineral and Spring Water) and of Prepackaged Ice, November 30, 1981;
(b) naturally occurring fluoride ion in an amount that exceeds its naturally occurring amount; or
(c) added fluoride in such an amount that the total amount therein of added and naturally occurring fluoride ion exceeds one part per million.
B.12.006 The common name of water in sealed containers, other than water represented as mineral water or spring water, shall be “Water”, modified by the word
(a) “Distilled” when the treatment of the water includes its vaporization and condensation;
(b) “Demineralized” when the treatment of the water is such that the mineral content of the water is reduced, by means other than distillation, to less than 10 parts per million; and
(c) “Carbonated” when the water contains added carbon dioxide.
B.12.007 Notwithstanding section B.01.008, when chlorine or any compounds of chlorine have been
(a) used in the treatment of water in sealed containers, other than water represented as mineral water or spring water, and
(b) subsequently removed from the water together with any chlorine and compounds of chlorine produced in the water,
chlorine or any compounds of chlorine need not be shown as ingredients on any part of the label on a sealed container of that water.
B.12.008 A statement of the total fluoride ion content expressed in parts per million shall appear on the principal display panel of the label on a sealed container of water, other than water represented as mineral water or spring water and on the label on a container of prepackaged ice.
B.12.009 The label on a sealed container of water, other than water represented as mineral water or spring water, shall bear a description on its principal display panel of any treatment the water has undergone, with the exception of the following:
(a) the addition of an ingredient declared in the list of ingredients;
(b) chlorination followed by the removal of the agent used for the chlorination together with any chlorine and compounds of chlorine produced in the water;
(c) decantation; and
(d) filtration.
DIVISION 13
Grain And Bakery Products
B.13.001 [S]. Flour, White Flour, Enriched Flour or Enriched White Flour
(a) shall be the food prepared by the grinding and bolting through cloth having openings not larger than those of woven wire cloth designated “149 microns (No. 100)”, of cleaned milling grades of wheat;
(b) shall be free from bran coat and germ to such an extent that the percentage of ash therein, before the addition of any other material permitted by this section, calculated on a moisture-free basis, does not exceed 1.20 per cent;
(c) shall have a moisture content of not more than 15 per cent;
(d) shall contain in 100 grams of flour
(i) 0.64 milligram of thiamine,
(ii) 0.40 milligram of riboflavin,
(iii) 5.30 milligrams of niacin or niacinamide,
(iv) 0.15 milligram of folic acid, and
(v) 4.4 milligrams of iron;
(e) may contain
(i) malted wheat flour,
(ii) malted barley flour in an amount not exceeding 0.50 per cent of the weight of the flour,
(iii) amylase, amylase (maltogenic), bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, protease, pullulanase or xylanase,
(iv) chlorine,
(v) chlorine dioxide,
(vi) benzoyl peroxide in an amount not exceeding 150 parts by weight for each one million parts of flour, with or without not more than 900 parts by weight for each one million parts of flour of one or a mixture of two or more of calcium carbonate, calcium sulphate, dicalcium phosphate, magnesium carbonate, potassium aluminum sulphate, sodium aluminum sulphate, starch and tricalcium phosphate as carriers of the benzoyl peroxide,
(vii) [Repealed, SOR/94-227, s. 1]
(viii) ammonium persulphate in an amount not exceeding 250 parts by weight for each one million parts of flour,
(ix) ammonium chloride in an amount not exceeding 2,000 parts by weight for each one million parts of flour,
(x) acetone peroxide,
(xi) azodicarbonamide in an amount not exceeding 45 parts by weight for each one million parts of flour,
(xii) ascorbic acid in an amount not exceeding 200 parts by weight for each one million parts of flour,
(xiii) l-cysteine (hydrochloride) in an amount not exceeding 90 parts by weight for each one million parts of flour,
(xiv) monocalcium phosphate in an amount not exceeding 7,500 parts by weight for each one million parts of flour, and
(xv) in 100 grams of flour
(A) 0.31 milligram of vitamin B6,
(B) 1.3 milligrams of d-pantothenic acid, and
(C) 190 milligrams of magnesium; and
(f) may contain calcium carbonate, edible bone meal, chalk (B.P.), ground limestone or calcium sulphate in an amount that will provide in 100 grams of flour 140 milligrams of calcium.
(g) [Repealed, SOR/97-151, s. 21]
B.13.002 Notwithstanding section B.13.001, flour, white flour, enriched flour or enriched white flour, used in or sold for the manufacture of gluten or starch is not required to contain added thiamine, riboflavin, niacin, folic acid or iron.
B.13.003 [S]. Vitamin B White Flour (Canada Approved)
(a) shall be flour that has been milled in such a way as to retain a high proportion of the vitamins naturally occurring in the original wheat berry;
(b) shall constitute not less than 70 per cent of the wheat from which it is milled;
(c) shall be bolted through at least one cloth having openings not larger than those of woven wire cloth designated “149 microns (No. 100)”; and
(d) shall contain, on a moisture-free basis,
(i) in one pound an amount of the vitamin B complex that will contribute not less than 1.2 milligrams of thiamine, and
(ii) not more than 0.70 per cent and not less than 0.61 per cent ash.
B.13.004 [Repealed, SOR/79-252, s. 2]
B.13.005 [S]. Whole Wheat Flour or Entire Wheat Flour
(a) shall be the food prepared by the grinding and bolting of cleaned, milling grades of wheat from which a part of the outer bran or epidermis layer may have been separated;
(b) shall contain the natural constituents of the wheat berry to the extent of not less than 95 per cent of the total weight of the wheat from which it is milled;
(c) shall have
(i) an ash content, calculated on a moisture-free basis, of not less than 1.25 per cent and not more than 2.25 per cent,
(ii) a moisture content of not more than 15 per cent, and
(iii) such a degree of fineness that not less than 90 per cent bolts freely through a No. 8 (2 380 micron) sieve, and not less than 50 per cent through a No. 20 (840 micron) sieve; and
(d) may contain
(i) malted wheat flour,
(ii) malted barley flour in an amount not exceeding 0.50 per cent of the weight of the flour,
(iii) amylase, amylase (maltogenic), bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, protease, pullulanase, or xylanase,
(iv) chlorine,
(v) chlorine dioxide,
(vi) benzoyl peroxide in an amount not exceeding 150 parts by weight for each one million parts of flour, with or without not more than 900 parts by weight for each one million parts of flour of one or a mixture of two or more of calcium carbonate, calcium sulphate, dicalcium phosphate, magnesium carbonate, potassium aluminum sulphate, sodium aluminum sulphate, starch and tricalcium phosphate as carriers of the benzoyl peroxide,
(vii) [Repealed, SOR/94-227, s. 2]
(viii) ammonium persulphate in an amount not exceeding 250 parts by weight for each one million parts of flour,
(ix) ammonium chloride in an amount not exceeding 2,000 parts by weight for each one million parts of flour,
(x) azodicarbonamide in an amount not exceeding 45 parts by weight for each one million parts of flour,
(xi) acetone peroxide,
(xii) ascorbic acid in an amount not exceeding 200 parts by weight for each one million parts of flour, and
(xiii) l-cysteine (hydrochloride) in an amount not exceeding 90 parts by weight for each one million parts of flour.
(e) [Repealed, SOR/97-151, s. 22]
B.13.006 [S]. Graham Flour shall be flour to which has been added part of the bran and other constituents of the wheat berry, and shall have an ash content, calculated on a moisture-free basis, of not less than 1.20 per cent and not more than 2.25 per cent.
B.13.007 [S]. Gluten Flour shall be the food obtained by removing from flour a part of the starch and shall not contain more than
(a) 10 per cent moisture, and
(b) 44 per cent Starch, calculated on a moisture-free basis, as determined by official method FO-28, Determination of Starch in Gluten Flour, October 15, 1981.
B.13.008 [S]. Crushed Wheat or Coarse Ground Wheat shall be the food prepared by so crushing cleaned wheat that 40 per cent or more passes through a No. 8 (2 380 micron) sieve and less than 50 per cent through a No. 20 (840 micron) sieve, the proportions of the natural constituents of such wheat, other than moisture, remaining unaltered and shall have
(a) an ash content, calculated on a moisture-free basis, of not less than 1.50 per cent and not more than 2.25 per cent; and
(b) a moisture content of not more than 15.5 per cent.
B.13.009 [S]. Cracked Wheat shall be the food prepared by so cracking or cutting cleaned wheat into angular fragments that not less than 90 per cent passes through a No. 8 (2 380 micron) sieve and not more than 20 per cent through a No. 20 (840 micron) sieve, the proportions of the natural constituents of such wheat, other than moisture, remaining unaltered and shall have
(a) an ash content, calculated on a moisture-free basis, of not less than 1.50 per cent and not more than 2.25 per cent; and
(b) a moisture content of not more than 15.5 per cent.
B.13.010 [S]. Rice shall be the hulled or hulled and polished seed of the rice plant and, in the case of hulled and polished seeds, may be coated with magnesium silicate, talc and glucose.
B.13.010.1 (1) For the purposes of this Division, precooked rice means polished rice that has been cooked in water or steam and dried in such a manner as to retain the rice grains in a porous and open-structured condition.
(2) Notwithstanding sections D.01.009, D.01.011 and D.02.009, no person shall sell pre-cooked rice to which a vitamin or mineral nutrient set out in Column I of an item of the table to this section has been added, either singly or in any combination, unless each 100 g of the pre-cooked rice as sold contains the added vitamin or mineral nutrient in the amount set out in Column II of that item.
TABLE
Column IColumn IIItemVitamin or Mineral NutrientAmount per 100 g of Pre-cooked Rice1Thiamine0.45 mg2Niacin4.2 mg3Vitamin B60.6 mg4Folic acid0.016 mg5Pantothenic acid1.2 mg6Iron1.6 mg(3) No person shall represent pre-cooked rice as “enriched” unless the food contains added thiamine, niacin and iron.
B.13.011 [S]. Corn Starch shall be starch made from maize and shall contain not less than 84 per cent starch.
B.13.014 For the purpose of this Division, moisture, ash and fineness shall be determined by the following applicable official methods:
(a) FO-29, Determination of Moisture in Grain, October 15, 1981;
(b) FO-30, Determination of Ash in Grain, October 15, 1981; and
(c) FO-31, Determination of Degree of Fineness of Grain, October 15, 1981.
B.13.015 [S]. Cottonseed Flour or similar products from cottonseed shall be derived from decorticated, defatted or partially defatted, cooked, ground cottonseed kernels and contain not more than 450 parts per million of free gossypol.
B.13.020 In this Division, milk solids means the entire solids content from milk, partly skimmed milk or skim milk or their concentrated, dried or reconstituted form, singly or in any combination.
Bread
B.13.021 [S]. Bread or White Bread shall be the food made by baking a yeast-leavened dough prepared with flour and water and may contain
(a) salt;
(b) shortening, lard, butter or margarine;
(c) milk or milk product;
(d) whole egg, egg-white; egg-yolk, (fresh, dried, or frozen);
(e) a sweetening agent;
(f) malt syrup, malt extract or malt flour;
(g) inactive dried yeast of the genus Saccharomyces cerevisiae in an amount not greater than two parts by weight for each 100 parts of flour used;
(h) amylase, amylase (maltogenic), bromelain, glucoamylase, glucose oxidase, lactase, lipase, lipoxidase, pentosanase, protease, pullulanase, or xylanase;
(i) subject to section B.13.029, one or more of the following in a total amount not exceeding five parts by weight per 100 parts of flour used, namely, whole wheat flour, entire wheat flour, graham flour, gluten flour, wheat meal, wheat starch, non-wheat flour, non-wheat meal or non-wheat starch, any of which may be wholly or partially dextrinized;
(j) other parts of the wheat berry;
(k) lecithin or ammonium salt of phosphorylated glyceride;
(l) monoglycerides and diglycerides of fat-forming fatty acids,
(m) ammonium chloride, ammonium sulphate, calcium carbonate, calcium lactate, diammonium phosphate, dicalcium phosphate, monoammonium phosphate or any combination thereof in an amount not greater than 0.25 parts by weight of all such additives for each 100 parts of flour used;
(n) monocalcium phosphate in an amount not greater than 0.75 parts by weight for each 100 parts of flour used;
(o) calcium peroxide, ammonium persulphate, potassium persulphate or any combination thereof in an amount not greater than 0.01 part by weight of all such additives for each 100 parts of flour used;
(p) acetone peroxide;
(q) vinegar;
(r) Class III preservative;
(s) food colour;
(t) calcium stearoyl-2-lactylate or sodium stearoyl-2-lactylate in an amount not greater than 0.375 parts by weight for each 100 parts of flour used;
(u) l-cysteine (hydrochloride) in an amount not greater than 0.009 parts by weight for each 100 parts of flour used;
(v) calcium sulphate in an amount not greater than 0.5 parts by weight for each 100 parts of flour used;
(w) sodium stearyl fumarate in an amount not greater than 0.5 parts by weight for each 100 parts of flour used;
(x) ascorbic acid in an amount not greater than 0.02 parts by weight for each 100 parts of flour used;
(y) lactic acid;
(z) azodicarbonamide in an amount not exceeding 45 parts by weight for each one million parts of flour;
(aa) calcium iodate, potassium iodate or any combination thereof in an amount not greater than 45 parts by weight of all such additives for each one million parts of flour; and
(bb) acetylated tartaric acid esters of mono- and diglycerides in an amount not greater than 0.6 parts by weight for each 100 parts of flour used.
B.13.022 [S]. Enriched Bread or Enriched White Bread
(a) shall be bread that is baked from a dough in which enriched flour is the only wheat flour used;
(b) shall contain
(i) for each 100 parts of flour used, not less than
(A) two parts by weight of skim milk solids,
(B) four parts by weight of dried whey powder, or
(C) such amount of the protein product made from peas (Pisum sativum) or soybeans (Glycine max) as will provide 0.5 parts by weight of protein, and
(ii) in 100 grams of bread,
(A) 0.40 milligram of thiamine,
(B) 0.24 milligram of riboflavin,
(C) 3.3 milligrams of niacin or niacinamide,
(D) 0.10 milligram of folic acid, and
(E) 2.76 milligrams of iron;
(c) may contain, in 100 grams of bread,
(i) 0.14 milligram of vitamin B6,
(ii) 0.6 milligram of d-pantothenic acid,
(iii) 90 milligrams of magnesium, and
(iv) 66 milligrams of calcium; and
(d) where it contains not less than six parts by weight of milk solids per 100 parts of enriched flour used, may be described by the common name “milk bread”.
B.13.023 and B.13.024 [Repealed, SOR/79-252, s. 3]
B.13.025 [S]. Raisin Bread shall be bread that contains for each 100 parts by weight of flour used not less than 50 parts by weight of seeded or seedless raisins, or raisins and currants of which not less than 35 parts shall be raisins and may contain spices or peel.
B.13.026 [S]. (naming the percentage) Whole Wheat Bread
(a) shall
(i) be bread in the making of which the named percentage of the flour used shall be whole wheat flour, and
(ii) contain not less than 60 per cent whole wheat flour in relation to the total flour used; and
(b) may
(i) contain caramel, and
(ii) where it contains not less than six parts by weight of milk solids per 100 parts of the total enriched flour and whole wheat flour used, be described by the common name “(naming the percentage) whole wheat milk bread”.
B.13.027 [S]. Brown Bread shall be bread coloured by the use of whole wheat flour, graham flour, bran, molasses or caramel.
B.13.028 [Repealed, SOR/97-151, s. 23]
B.13.029 A specialty bread may contain
(a) one or more of the ingredients specified in paragraph B.13.021(i) in a total amount greater than the total amount specified in that paragraph; and
(b) fruit, nuts, seeds and flavouring.
Alimentary Paste
B.13.051 No person shall sell macaroni, spaghetti, noodles or similar alimentary pastes, as egg macaroni, egg spaghetti, egg noodles or egg alimentary pastes, respectively, unless they contain, on the dry basis, not less than four per cent, egg-yolk solids derived from whole egg, dried egg, frozen egg or frozen egg-yolk.
B.13.052 (1) Notwithstanding sections D.01.009, D.01.011 and D.02.009, no person shall sell an alimentary paste to which a vitamin or a mineral nutrient set out in column I of any item of the table to this section has been added unless each 100 g of the alimentary paste contains the added vitamin or mineral nutrient in an amount not less than the minimum amount set out in column II of that item and not more than the maximum amount set out in column III of that item.
(2) No person shall represent an alimentary paste as “enriched” unless the alimentary paste contains added thiamine, riboflavin, niacin, folic acid and iron, in accordance with the table to this section.
TABLE
ItemColumn IColumn IIColumn IIIAdded Vitamin or Mineral NutrientMinimum Amount per 100 g of Alimentary PasteMaximum Amount per 100 g of Alimentary Paste1Thiamine0.63 mg1.50 mg2Riboflavin0.11 mg0.60 mg3Niacin5.90 mg7.50 mg4Folic Acid0.20 mg0.27 mg5Pantothenic Acid1.00 mg2.00 mg6Vitamin B60.40 mg0.80 mg7Iron2.90 mg4.30 mg8Magnesium150.00 mg300.00 mgBreakfast Cereal
B.13.060 Notwithstanding sections D.01.009, D.01.011 and D.02.009, no person shall sell a breakfast cereal to which a vitamin or mineral nutrient set out in Column I of an item of the table to this section has been added, either singly or in any combination, unless each 100 g of the breakfast cereal contains the added vitamin or mineral nutrient in the amount set out in Column II of that item.
TABLE
Column IColumn IIItemVitamin or Mineral NutrientAmount per 100 g of Breakfast Cereal1Thiamine2.0 mg2Niacin4.8 mg3Vitamin B60.6 mg4Folic Acid0.06 mg5Pantothenic Acid1.6 mg6Magnesium160.0 mg7Iron13.3 mg8Zinc3.5 mgDIVISION 14
Meat, Its Preparations And Products
B.14.001 In this Division,
animal
animal means any animal used as food, but does not include marine and fresh water animals; (animal)
filler
filler means any vegetable material (except tomato or beetroot), milk, egg, yeast or any derivative or combination thereof that is acceptable as food. (agent de remplissage)
B.14.002 [S]. Meat shall be the edible part of the skeletal muscle of an animal that was healthy at the time of slaughter, or muscle that is found in the tongue, diaphragm, heart or oesophagus, and may contain accompanying and overlying fat together with the portions of bone, skin, sinew, nerve and blood vessels that normally accompany the muscle tissue and are not separated from it in the process of dressing, but does not include muscle found in the lips, snout, scalp or ears.
B.14.003 [S]. Meat by-product shall be any edible part of an animal, other than meat, that has been derived from one or more animals that were healthy at the time of slaughter.
B.14.004 Meat, meat by-products or preparations thereof are adulterated if any of the following substances or class of substances are present therein or have been added thereto:
(a) mucous membranes, any organ or portions of the genital system, black gut, spleens, udders, lungs or any other organ or portion of animal that is not commonly sold as an article of food;
(b) preservatives other than those provided for in this Division; or
(c) colour other than annatto, allura red and sunset yellow FCF, where provided for in this Division, and caramel.
B.14.005 [S]. Prepared meat or a prepared meat by-product shall be any meat or any meat by-product, respectively, whether comminuted or not, to which has been added any ingredient permitted by these Regulations, or which has been preserved, placed in a hermetically-sealed container or cooked, and may contain
(a) in the case of prepared hams, shoulders, butts, picnics and backs, gelatin;
(b) in the case of partially defatted pork fatty tissue and partially defatted beef fatty tissue, a Class IV preservative; and
(c) where a minimum total protein content or a minimum meat protein content is prescribed in this Division, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,
(i) sodium acid pyrophosphate,
(ii) sodium hexametaphosphate,
(iii) sodium phosphate, dibasic,
(iv) sodium phosphate, monobasic,
(v) sodium pyrophosphate, tetrabasic,
(vi) sodium tripolyphosphate,
(vii) potassium phosphate, monobasic,
(viii) potassium phosphate, dibasic, and
(ix) potassium pyrophosphate, tetrabasic.
B.14.006 Powdered hydrogenated cottonseed oil in an amount not greater than 0.25 per cent of the product may be applied as a release agent to the surface of meat, meat by-product, prepared meat, prepared meat by-product, extended meat product and simulated meat product.
B.14.007 [S]. Meat Binder or (naming the meat product) Binder shall be a filler with any combination of salt, sweetening agents, spices or other seasonings (except tomato), egg, egg albumen, and
(a) where sold for use in preserved meat and preserved meat by-product, may contain potassium nitrate, potassium nitrite, sodium nitrate, sodium nitrite, ascorbic acid, sodium ascorbate, erythorbic acid, sodium erythorbate and sodium carbonate, if the nitrate or nitrite salts or both are packaged separately from any spice or seasoning;
(b) where sold for use in prepared meat or meat by-product in which a gelling agent is a permitted ingredient, may contain a gelling agent;
(c) where sold for use in fresh, uncooked sausage, may contain artificial maple flavour; and
(d) may contain an anticaking agent.
B.14.008 No person shall sell a meat binder, filler or preparations for pumping pickle, cover pickle or dry cure represented for use in meat products unless the label thereof carries directions for use that when followed will produce a food that will comply with the requirements of section B.14.030 insofar as the filler is concerned and the food will not contain food additives in excess of the maximum levels of use prescribed by these Regulations.
B.14.009 [S]. Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product may contain
(a) Class I preservatives if the nitrate or nitrite salts or both are packaged separately from any spice or seasoning;
(b) citric acid, sodium citrate or vinegar;
(c) sweetening agents, including maple sugar and maple syrup;
(d) liquid smoke flavour, liquid smoke flavour concentrate, salt, seasonings, spices, spice extracts, spice oils or spice oleoresins;
(e) sodium bicarbonate, sodium hydroxide or potassium hydroxide;
(f) in the case of pumping pickle for cured pork, beef and lamb cuts, disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate in such amount calculated as disodium phosphate, as will result in the finished product containing not more than 0.5 per cent added phosphate;
(g) in the case of pumping pickle for cured beef cuts, enzymes, if the principal display panel of the label of the cured beef carries, immediately preceding or following the common name, the statement “Tenderized with (naming the proteolytic enzyme or enzymes)”;
(h) in the case of dry cure, an anticaking agent or a humectant; and
(i) in the case of pumping pickle
(i) for cured pork hams, shoulders and backs, artificial maple flavour, and
(ii) for cured pork bellies, artificial maple flavour and an orange flavour that meets the standard prescribed in section B.10.005.
B.14.010 No person shall sell as food a dead animal or any part thereof.
B.14.011 No person shall sell as food, meat, meat by-products, preparations containing meat or meat derivatives obtained, prepared or manufactured from a dead animal.
B.14.012 For the purpose of Sections B.14.010 and B.14.011, dead animal means a dead animal that
(a) was not killed for the purpose of food in accordance with commonly accepted practice of killing animals for the purpose of food, which shall include exsanguination; or
(b) was affected with disease at the time it was killed.
B.14.013 and B.14.014 [Repealed, SOR/97-148, s. 3]
Meat, Meat By-products
B.14.015 [S]. Regular Ground Beef shall be beef meat processed by grinding and shall contain not more than 30 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981.
B.14.015A [S]. Medium Ground Beef shall be beef meat processed by grinding and shall contain not more than 23 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981.
B.14.015B [S]. Lean Ground Beef shall be beef meat processed by grinding and shall contain not more than 17 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981.
B.14.015C No person shall sell ground beef that contains more than 30 per cent beef fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981.
B.14.016 No person shall sell horse-meat or horse-meat by-product, or any food containing horse-meat or horse-meat by-product unless
(a) it is labelled as such when offered or exposed for sale; and
(b) when in package form, the principal display panel of the label carries a declaration of the presence of horse-meat or of horse-meat by-product in type at least as legible and conspicuous as any other type upon such principal display panel.
B.14.017 [Repealed, SOR/2003-292, s. 2]
B.14.018 (1) Subject to subsection (2), if a carcass of beef or veal, or a portion of a carcass of beef or veal that weighs 7 kg or more, is advertised for sale, the advertisement shall indicate
(a) in the case of a carcass other than an imported carcass, the grade that was assigned to the carcass by a grading authority established under the Canada Agricultural Products Act or a provincial law;
(b) in the case of an imported beef carcass, the grade that was assigned to the carcass by a grading authority established under the Canada Agricultural Products Act or a provincial law or the grade that was assigned to the carcass by a grading authority established under the laws of the country from which the carcass was imported;
(c) in the case of an imported veal carcass, the grade that was assigned to the carcass by a grading authority established under the laws of the country from which the carcass was imported; and
(d) in the case of a beef carcass, the yield class, if any, that was assigned to the carcass by a grading authority established under the Canada Agricultural Products Act.
(2) Where, in the case of a carcass referred to in subsection (1), no grade has been assigned thereto as described in that subsection and the carcass or portion thereof that weighs 7 kg or more is advertised for sale, the advertisement shall clearly indicate that the carcass has not been graded.
B.14.019 (1) Where a carcass of beef, veal, pork or lamb or a portion thereof that weighs 7 kg or more is advertised for sale and a selling price is stated in the advertisement, the advertisement shall
(a) contain the words “price per kilogram is based on carcass weight before cutting, boning and trimming” or the words “price per kilogram is based on the weight of the meat after cutting, boning and trimming”, whichever words are applicable; and
(b) where in addition to the selling price a charge is payable for cutting, boning, trimming, wrapping or freezing the carcass or portion thereof, indicate
(i) the amount of the additional charge, and
(ii) where the additional charge is payable on a price per unit weight basis, whether the additional charge is based on the weight of the carcass or portion thereof before or after the carcass has been cut, boned and trimmed.
(2) Any information required by subsection (1) to appear in an advertisement shall be located therein immediately adjacent to the selling price stated therein, without any intervening written, printed or graphic matter.
B.14.020 [S]. Solid cut meat shall be
(a) a whole cut of meat; or
(b) a product consisting of pieces of meat of which at least 80 per cent weigh at least 25 g each.
B.14.021 (1) No person shall sell solid cut meat to which phosphate salts or water has been added unless
(a) in the case of meat, other than side bacon, Wiltshire bacon, pork jowls, salt pork and salt beef, the meat
(i) where cooked, contains a meat protein content of not less than 12 per cent, and
(ii) where uncooked, contains a meat protein content of not less than 10 per cent; and
(b) that meat contains, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,
(i) sodium acid pyrophosphate,
(ii) sodium hexametaphosphate,
(iii) sodium phosphate, dibasic,
(iv) sodium phosphate, monobasic,
(v) sodium pyrophosphate, tetrabasic,
(vi) sodium tripolyphosphate,
(vii) potassium phosphate, monobasic,
(viii) potassium phosphate, dibasic, and
(ix) potassium pyrophosphate, tetrabasic.
(2) A bone or a visible fat layer shall not be included in any calculation used to determine meat protein content for the purposes of paragraph (1)(a).
Prepared Meats, Prepared Meat By-products
B.14.030 (1) Subject to subsections (2) and (3) and section B.14.030A, no person shall sell a prepared meat or prepared meat by-product with a meat protein content of less than 1.5 percentage points below the total protein requirement for that food.
(2) Subsection (1) does not apply to an extended meat product.
(3) Where gelatin is an ingredient of a prepared meat or prepared meat by-product, that gelatin shall not be included when calculating the total protein content of the prepared meat or prepared meat by-product.
B.14.030A For the purposes of sections B.14.030, B.14.032, B.14.033, B.14.035, B.14.074, B.14.075, B.14.076 and B.14.077, where any of the non-meat ingredients listed in paragraphs B.14.032A(a) to (g) are present in a prepared meat or prepared meat by-product in separate identifiable pieces or chunks in any amount sufficient to differentiate those ingredients from the prepared meat or prepared meat by-product, those ingredients shall not be included when calculating the fat or protein content of the prepared meat or prepared meat by-product.
B.14.031 [S]. Preserved Meat or Preserved Meat By-product shall be cooked or uncooked meat or meat by-product that is salted, dried, pickled, corned, cured or smoked, may be glazed and may contain
(a) Class I preservative;
(b) sweetening agents;
(c) spices and seasonings, except tomato;
(d) vinegar;
(e) alcohol;
(f) smoke flavouring or artificial smoke flavouring;
(g) in the case of cured pork hams, shoulders, backs and bellies, artificial maple flavour;
(gg) in the case of cured pork bellies, an added orange flavour that meets the standard prescribed in section B.10.005;
(h) in the case of cured pork, beef and lamb cuts prepared with the aid of pumping pickle, disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate in such amount calculated as disodium phosphate, as will result in the finished product containing not more than 0.5 per cent added phosphate; and
(i) in the case of tocino, annatto in such amount as will result in the finished product containing not more that 0.1 per cent annatto, if annatto is shown, by the word “annatto”, in the list of ingredients on the label.
B.14.032 [S]. Sausage or Sausage Meat
(a) shall be fresh or preserved comminuted meat;
(b) may be enclosed in a casing;
(c) may be dipped in vinegar, smoked, cooked or dried;
(d) may contain
(i) animal fat,
(ii) filler,
(iii) beef tripe,
(iv) liver,
(v) fresh or frozen beef and pork blood,
(vi) sweetening agents,
(vii) salt and spices,
(viii) seasoning, other than tomato,
(ix) lactic acid producing starter culture,
(x) meat binder,
(xi) beef and pork blood plasma,
(xii) in the case of preserved comminuted meat, smoke flavouring or artificial smoke flavouring,
(xiii) if cooked
(A) glucono delta lactone,
(B) partially defatted beef fatty tissue or partially defatted pork fatty tissue, and
(C) a dried skim milk product, obtained from skim milk by the reduction of its calcium content and a corresponding increase in its sodium content, in an amount not exceeding three per cent of the finished food,
(xiv) in the case of fresh uncooked sausage, artificial maple flavour or apple powder as a flavouring ingredient,
(xv) in the case of dry sausage or dry sausage meat, glucono delta lactone, and
(xvi) in the case of longaniza,
(A) annatto in such amount as will result in the finished product containing not more than 1000 parts per million annatto, if annatto is shown, by the word “annatto”, in the list of ingredients on the label,
(B) allura red in such amount as will result in the finished product containing not more than 80 parts per million allura red, if allura red is shown, by the words “allura red”, in the list of ingredients on the label, and
(C) sunset yellow FCF in such amount as will result in the finished product containing not more than 20 parts per million sunset yellow FCF, if sunset yellow FCF is shown, by the words “sunset yellow FCF”, in the list of ingredients on the label.
(e) shall contain, in the case of a product sold as fresh sausage, not more than 40 per cent fat, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;
(f) shall have, if cooked, a total protein content of not less than 11 per cent;
(g) shall have, in the case of fresh uncooked sausage and fresh uncooked sausage meat, a total protein content of not less than nine per cent.
B.14.032A [S]. (naming the prepared meat or prepared meat by-product) with (naming the non-meat ingredients) shall be prepared meat to which has been added other non-meat ingredients including
(a) fruit;
(b) vegetables;
(c) nuts;
(d) cheese or processed cheese;
(e) macaroni;
(f) pickles; or
(g) olives.
B.14.032AA Where the non-meat ingredients referred to in section B.14.032A are added to prepared meat in such a manner that they are not present in the final product in separate identifiable pieces or chunks, the final product shall meet the total protein content requirement established for (naming the prepared meat or prepared meat by-product) referred to in section B.14.032A.
B.14.033 [S]. Potted Meat, Meat Paste, or Meat Spread shall be comminuted and cooked, fresh or preserved meat and may contain meat binder, salt, sweetening agents, spices, other seasonings and a gelling agent and shall have a total protein content of not less than nine per cent.
B.14.034 [S]. Potted Meat By-product, Meat By-product Paste or Meat By-product Spread shall be a food that
(a) consists, wholly or in part, of meat by-products and conforms to the standard prescribed for potted meat; and
(b) in the case of liverpaste or liverwurst spread, may contain wheat germ and yeast.
B.14.035 [S]. Meat Loaf, Meat Roll, Meat Lunch or Luncheon Meat shall be comminuted and cooked, fresh or preserved meat, pressed into shape and may contain a dried skim milk product obtained from skim milk by the reduction of its calcium content and a corresponding increase in its sodium content, in an amount not exceeding three per cent of the finished food, filler, meat binder, salt, sweetening agents, glucono delta lactone, spices, other seasonings, milk, eggs, a gelling agent and partially defatted beef fatty tissue or partially defatted pork fatty tissue and shall have a total protein content of not less than 11 per cent.
B.14.036 [S]. Meat By-product Loaf or Meat and Meat By-product Loaf shall be the food consisting, wholly or in part, of meat by-products and shall otherwise conform to the standard prescribed for meat loaf.
B.14.037 [S]. Headcheese
(a) shall be comminuted cooked meat or comminuted cooked preserved meat,
(b) shall not contain
(i) less than 50 per cent head meat, or
(ii) skin, other than that naturally adherent to any pork meat used,
(c) may contain scalps, snouts, beef tripe, salt, spices, seasoning or an added gelling agent, and
(d) may contain
(i) ascorbic acid or its sodium salt, or
(ii) erythorbic acid or its sodium salt,
and for the purpose of this section scalp and snouts are deemed head meat.
B.14.038 [S]. Brawn shall be headcheese, except that it need not contain 50 per cent head meat.
B.14.039 Where a gelling agent has been added to prepared meat or prepared meat by-product, a statement to the effect that a gelling agent has been added shall be shown on the principal display panel or the word “jellied” shall be shown as an integral part of the common name of the food.
B.14.040 Subject to section B.14.032 and sections B.14.033 to B.14.036, no person shall sell a food that consists of a mixture of ground meat and filler, ground meat by-product and filler or ground meat, ground meat by-product and filler, unless that food
(a) has a total protein content of not less than 13 per cent;
(b) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of a mixture containing pork meat or pork meat by-product or both; and
(c) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of any other meat mixture.
B.14.041 Subject to section B.14.032 and sections B.14.033 to B.14.036, no person shall sell a food that consists of a mixture of ground meat and spices and seasonings, ground meat by-product and spices and seasonings, ground meat, ground meat by-product and spices and seasonings or ground meat and ground meat by-product, unless that food
(a) has a total protein content of not less than 16 per cent;
(b) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of a mixture containing pork meat or pork meat by-product or both; and
(c) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case of any other meat mixture.
Meat Derivatives
B.14.061 [S]. Edible Bone Meal or Edible Bone Flour shall be the food prepared by grinding dry, defatted bones, obtained from animals healthy at the time of slaughter and shall contain
(a) not less than 85 per cent ash, as determined by official method FO-34, Determination of Ash in Edible Bone Meal or Edible Bone Flour, October 15, 1981.
(b) and (c) [Repealed, SOR/97-148, s. 4]
B.14.062 [S]. (1) Gelatin or Edible Gelatin
(a) shall be the purified food obtained by the processing of skin, ligaments or bones of animals;
(b) shall contain not less than 82 per cent ash-free solids, when tested by official method FO-35, Determination of Ash-Free Solids in Gelatin, October 15, 1981;
(c) shall be free from objectionable taste and offensive odour when 2.5 grams thereof are dissolved in 100 millilitres of warm water;
(d) [Repealed, SOR/97-148, s. 5]
(e) shall not contain any residues of hydrogen peroxide where it has been used in the course of manufacture; and
(f) may contain
(i) not more than 2.6 per cent ash on a dry basis,
(ii) not more than 500 parts per million of sulphurous acid, including the salts thereof, calculated as sulphur dioxide, and
(iii) where intended for use in the manufacture of marshmallow, sodium hexametaphosphate or sodium lauryl sulphate.
(2) No person shall use, in the course of manufacturing gelatin or edible gelatin,
(a) acidic or basic compounds other than acetic acid, ammonium hydroxide, citric acid, fumaric acid, hydrochloric acid, lime, magnesium hydroxide, phosphoric acid, sodium carbonate, sodium hydroxide, sodium sulphide, sulphuric acid, sulphurous acid or tartaric acid; or
(b) filtering and clarifying agents other than activated carbon, alumina, aluminum sulphate, calcium phosphate, dibasic, cellulose, diatomaceous earth, perlite, strongly acidic cation exchange resin in the hydrogen ion form or basic anion exchange resins in the chloride ion or free base ion forms.
Meat Stews
B.14.063 For the purposes of sections B.14.064 to B.14.068, stew meat means meat that contains when raw not more than
(a) 25 per cent fat, in the case of meat in meat ball stews; and
(b) 20 per cent fat, in the case of meat in other stews.
B.14.064 [S]. Vegetable Stew with (naming the meat)
(a) shall contain vegetables and the named meat in the following amounts, calculated as raw ingredients:
(i) 12 per cent or more stew meat, and
(ii) 38 per cent or more vegetables; and
(b) may contain gravy, salt, seasoning and spices.
B.14.065 [S]. (naming the meat) Stew
(a) shall contain vegetables and the named meat in the following amounts, calculated as raw ingredients:
(i) 20 per cent or more stew meat, and
(ii) 30 per cent or more vegetables; and
(b) may contain gravy, salt, seasoning and spices.
B.14.066 [S]. Irish Stew
(a) shall contain mutton, lamb or beef, singly or in any combination, and vegetables, in the following amounts, calculated as raw ingredients:
(i) 20 per cent or more stew meat,
(ii) 30 per cent or more vegetables; and
(b) may contain gravy, salt, seasoning and spices.
B.14.067 [S]. Meat Ball Stew
(a) shall contain vegetables and meat balls in the following amounts, calculated as raw ingredients:
(i) 22 per cent or more meat balls,
(ii) 30 per cent or more vegetables; and
(b) may contain gravy, salt, seasoning and spices.
B.14.068 [S]. Specialty Meat Stews
(a) shall contain meat and vegetables in the following amounts, calculated as raw ingredients:
(i) 25 per cent or more stew meat,
(ii) 30 per cent or more vegetables; and
(b) may contain gravy, salt, seasoning and spices.
Meat Specialties
B.14.070 [S]. Wieners and Beans or Wieners with Beans shall be the food prepared from dried beans and wieners, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 25 per cent wieners, as determined by official method FO-36, Determination of Wiener Content of Meat Specialties, October 15, 1981.
B.14.071 [S]. Beans and Wieners or Beans with Wieners shall be the food prepared from dried beans and wieners, may contain sauce, seasoning, spices and a sweetening agent and shall contain not less than 10 per cent wieners, as determined by official method FO-36, Determination of Wiener Content of Meat Specialties, October 15, 1981.
Sale of Barbecued, Roasted or Broiled Meat or Meat By-Products
B.14.072 No person shall sell meat or a meat by-product that has been barbecued, roasted or broiled and is ready for consumption unless the cooked meat or meat by-product
(a) at all times
(i) has a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher, or
(ii) has been stored at an ambient temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher; and
(b) carries on the principal display panel of the label a statement to the effect that the food must be stored at a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher.
Meat Product Extender
B.14.073 No person shall sell a meat product extender intended to be used in a food consisting of a mixture described in section B.14.074, B.14.075, B.14.076, B.14.077 or B.14.078, unless that extender
(a) has, in the rehydrated state,
(i) a total protein content of not less than 16 per cent, and
(ii) a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;
(b) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and
(c) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.
Extended Meat Products
B.14.074 Subject to sections B.14.075 to B.14.079, no person shall sell a food that consists of a mixture of meat product and meat product extender, unless that food
(a) has a total protein content of not less than 16 per cent;
(b) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and
(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).
B.14.075 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles fresh sausage, unless that food
(a) has a total protein content of not less than nine per cent;
(b) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and
(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).
B.14.076 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles cooked sausage, meat loaf, meat by-product loaf, meat roll, meat lunch, or luncheon meat, unless that food
(a) has a total protein content of not less than 11 per cent;
(b) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and
(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).
B.14.077 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles potted meat, potted meat by-product, meat paste, meat by-product paste, meat spread, or meat by-product spread, unless that food
(a) has a total protein content of not less than nine per cent;
(b) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and
(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).
B.14.078 No person shall sell a food that consists of a mixture of meat product and meat product extender and that resembles regular ground beef, medium ground beef or lean ground beef, unless that food
(a) has a total protein content of not less than 16 per cent;
(b) has a fat content of
(i) not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being regular,
(ii) not more than 23 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being medium, or
(iii) not more than 17 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being lean; and
(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).
B.14.079 No person shall sell a food that consists of a mixture of meat product, filler and meat product extender, unless that food
(a) has a total protein content of not less than 13 per cent;
(b) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981; and
(c) in respect of the meat product extender, meets the requirements of paragraphs B.14.073(a) to (c).
Simulated Meat Products
B.14.085 Subject to sections B.14.086 to B.14.090 no person shall sell a simulated meat product unless that product
(a) has, in the rehydrated state,
(i) a total protein content of not less than 16 per cent,
(ii) a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981, and
(iii) a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;
(b) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and
(c) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.
B.14.086 No person shall sell a simulated meat product that resembles fresh sausage, unless that product
(a) has a total protein content of not less than nine per cent;
(b) has a protein rating of not less than 23, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;
(c) has a fat content of not more than 40 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;
(d) has, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and
(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.
B.14.087 No person shall sell a simulated meat product that resembles cooked sausage, meat loaf, meat by-product loaf, meat roll, meat lunch, or luncheon meat, unless that product
(a) has a total protein content of not less than 11 per cent;
(b) has a protein rating of not less than 28, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;
(c) has a fat content of not more than 25 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;
(d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and
(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.
B.14.088 No person shall sell a simulated meat product that resembles potted meat, potted meat by-product, meat paste, meat by-product paste, meat spread, or meat by-product spread, unless that product
(a) has a total protein content of not less than nine per cent;
(b) has a protein rating of not less than 23, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;
(c) has a fat content of not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981;
(d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each vitamin and mineral nutrient respectively; and
(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.
B.14.089 No person shall sell a simulated meat product that resembles regular ground beef, medium ground beef or lean ground beef, unless that product
(a) has a total protein content of not less than 16 per cent;
(b) has a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;
(c) has a fat content of
(i) not more than 30 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being regular,
(ii) not more than 23 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being medium, or
(iii) not more than 17 per cent, as determined by official method FO-33, Determination of Fat in Meat and Simulated Meat Products, October 15, 1981, in the case where the product is represented as being lean;
(d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient, respectively; and
(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.
B.14.090 No person shall sell a simulated meat product that resembles side bacon, unless that product
(a) has a total protein content of not less than 25 per cent;
(b) has a protein rating of not less than 20, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;
(c) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to this Division in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and
(d) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.
TABLE
Item No.Column IColumn IIVitamin or Mineral NutrientAmount per gram of proteinC.1 Copper 4.4 microgramsF.1 Folic Acid 0.45 microgramI.1 Iron 0.25 milligramM.1 Magnesium 1.1 milligramsN.1 Niacin 0.34 milligramP.1 Pantothenic Acid 0.04 milligramP.2 Potassium 20 milligramsP.3 Pyridoxine 0.02 milligramR.1 Riboflavin 0.01 milligramT.1 Thiamine 0.02 milligramV.1 Vitamin B120.08 microgramZ.1 Zinc 0.20 milligramDIVISION 15
Adulteration Of Food
B.15.001 A food named in Column III of an item of Table I to this Division is adulterated if the substance named in Column I of that item is present therein or has been added thereto in an amount exceeding the amount, expressed in parts per million, shown in Column II of that item for that food.
B.15.002 (1) Subject to subsections (2) and (3), a food is adulterated if an agricultural chemical or any of its derivatives is present therein or has been added thereto, singly or in any combination, in an amount exceeding 0.1 part per million, unless it is listed and used in accordance with the tables to Division 16.
(2) Subject to subsection (3), a food is exempt from paragraph 4(d) of the Act if the only agricultural chemicals that are present therein or have been added thereto are any of the following:
(a) a fertilizer;
(b) an adjuvant or a carrier of an agricultural chemical;
(c) an inorganic bromide salt;
(d) silicon dioxide;
(e) sulphur;
(f) viable spores of Bacillus thuringiensis Berliner; or
(g) Kaolin.
(3) A food named in column IV of an item of Table II to this Division, a food that contains any such food or a food made from a product of any such food is exempt from the application of paragraph 4(d) of the Act if the agricultural chemicals named in columns I and II of that item are present in or have been added to the food in an amount not exceeding the maximum residue limit set out in column III of that item.
(4) A food set out in a Notice of Interim Marketing Authorization published under subsection B.01.056(6) is exempt from paragraph 4(d) of the Act in respect of any agricultural chemical or derivative of such a chemical, and any veterinary drug, set out in that notice that is present in the food in an amount not exceeding the maximum residue limit, expressed in parts per million, set out for the food in that notice.
B.15.003 A food named in Column IV of an item of Table III to this Division is exempt from paragraph 4(d) of the Act if the drug named in Column I, and analysed as being the substance named in Column II, of that item is present in the food in an amount not exceeding the limit, expressed in parts per million, set out in Column III of that item for that food.
SOR/78-404, s. 1; SOR/79-249, s. 1; SOR/91-255, s. 1.
TABLE I
IIIIIIItem No.SubstanceTolerance p.p.m.Foods1Arsenic(1) 3.5(1) Fish protein(2) 1(2) Edible bone meal(3) 0.1(3) Fruit juice, fruit nectar, beverages when ready-to-serve and water in sealed containers other than mineral water or spring water2Fluoride(1) 650(1) Edible bone meal(2) 150(2) Fish Protein3Lead(1) 10(1) Edible bone meal(2) 1.5(2) Tomato paste and tomato sauce(3) 0.5(3) Fish protein and whole tomatoes(4) 0.2(4) Fruit juice, fruit nectar, beverages when ready-to-serve and water in sealed containers other than mineral water or spring water(5) 0.15(5) Evaporated milk, condensed milk and concentrated infant formula(6) 0.08(6) Infant formula when ready-to-serve4Tin(1) 250(1) Canned foodsTABLE II
AGRICULTURAL CHEMICALS
IIIIIIIVItem No.Common Chemical NameChemical Name of SubstanceMaximum Residue Limit p.p.m.FoodsA.001acephateO, S-dimethyl acetyl phosphoramidothioate5.0Celery2.0Cauliflower, peppers1.5Brussels sprouts1.0Lettuce, beans0.5Corn, cranberries, potatoes, soybeans0.3Cabbage0.05MilkA.0001abamectin(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-0-(2,6-dideoxy-3-0-methyl-∝-L-arabino-hexopyranosyl)-3-0-methyl-∝-L-arabino-hexopyranoside (avermectin B1a)0.05Celery, head lettuce0.02Apples, citrus fruits, pears, strawberries(10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R, 8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-0-(2,6-dideoxy-3-0-methyl-∝-L-arabino-hexopyranosyl)-3-0-methyl-∝-L-arabino-hexopyranoside (avermectin B1b)0.01Peppers, tomatoes0.005Almonds, cucumbers, walnutsA mixture of avermectin B1a and B1b, and their 8,9-Z isomers, in the ratio of 80 to 20 respectively.A.01alachlor2-chloro-2′,6′-diethyl-N
-methoxy-methylacetanilide including the metabolites containing the diethylaniline or 2-ethyl-6-(1-hydroxyethyl) aniline moieties0.2Soybeans0.02Corn, dry beans, soybean oil 0.001Meat, milkA.02aldicarb2-methyl-2-(methylthio) propionaldehyde-O- (methylcarbamoyl) oxime, including the metabolites aldicarb sulfoxide and aldicarb sulfone0.5PotatoesA.1aldrin and dieldrin1,2,3,4,10,10-hexachloro-1,4,4a,5,8,8a-hexahydro-1,4-endo, exo-5,8-dimethanonaphthalene0.2Meat, meat by-products and fat of cattle, goats, hogs, poultry and sheep.(calculated on the fat content)and1,2,3,4,10,10-hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4,-endo, exo-5,8-dimethanonaphthalene0.1Butter, cheese, milk and other dairy products(calculated on the fat content)A.1.1amitrazN
,N
-bis(2,4-xylyliminomethyl)1.0PearsA.1.2amitrole3-amino-s
-triazole0.01Barley, peas, rapeseed (canola), wheatmethylamine, including the metaboliteN
-(2,4-dimethylphenyl)-N
′-methyl formamidine0.5Apples0.2Liver and kidneys of cattle and hogsA.2anilazine2,4-dichloro-6-(2-chloroanilino)-1,3,5-triazine20Strawberries.10Blueberries, celery, cranberries, currants, garlic, gooseberries, leeks, onions, shallots, tomatoes.5Blackberries, cucumbers, dewberries, loganberries, melons, pumpkins, raspberries, squash.1PotatoesA.3azinphosmethylS-(3,4-dihydro-4-oxobenzo [d]-[1,2,3] triazin-3-ylmethyl)0,0-dimethyl phosphorodithioate5.0Grapes.2.0Apples, apricots, beans, blackberries, blueberries, boysenberries, citrus fruits, loganberries, peaches/nectarines, pears, quinces, raspberries, spinach.1.0Broccoli, Brussels sprouts, cabbage, cherries, cranberries, currants, onions (green), plums, tomatoes, strawberries.0.5Artichokes, cauliflower, celery, cucumbers, onions (dry bulb).0.4Kiwi fruit (edible portion).0.2Peppers.A.4azoxystrobin(αE)-methyl 2-[[6-(2-cyanophenoxy) -4-pyrimidinyl]oxy]-α-(methoxymethylene) benzeneacetate, including the isomer (Z)-methyl 2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]— (methoxymethylene)benzeneacetate3Grapes1Bananas, rapeseed (canola)0.8Peaches/nectarines0.6Tomato paste0.3Liver of cattle, hogs, horses and sheep0.2Tomatoes0.06Kidney of cattle, hogs, horses and sheep0.03Peanut oil0.01Meat and meat by-products of cattle, hogs, horses and sheep, peanuts, pecansBbenomyl, carbendazim and thiophanatemethylmethyl 1-(butylcarbamoyl) benzimidazol-2-ylcarbamate, methyl benzimidazol-2-ylcarbamate (carbendazim), and 1,2-di-(3-methoxy-carbonyl-2-thioureido) benzene, expressed as carbendazim10Citrus fruits, peaches/nectarines.6Blackberries, boysenberries, raspberries.5Apples, apricots, carrots, cherries, grapes, mushrooms, pears, plums, strawberries.2.5Tomatoes.1Beans, pineapples (edible pulp)0.5Cucumbers, melons, pumpkins, squash.B.01 bentazon3-(1-methylethyl)-1H-2,1,3- benzothiadiazin-4(3H)-one 2,2-dioxide, including the metabolites 6-hydroxy-3-(1-methylethyl)-1H-2,1,3-benzothiadiazin-4(3H)-one 2,2-dioxide and 8-hydroxy-3-(1-methylethyl)-1H-2,1,3-benzothiadiazin-4(3H)-one 2,2-dioxide3Peas0.5Beans0.1Barley, leeks, onions, wheat0.05Blueberries, corn, flax, peanuts, rice, soybeansB.1BHC isomers, except lindaneall isomers of 1,2,3,4,5,6-hexachloro-cyclohexane, except gamma BHC0.1Butter, cheese, milk and other dairy products, meat and meat by-products of cattle, goats, hogs, poultry and sheep.(calculated on the fat content)B.1.1[Repealed, SOR/83-265, s. 1]
B.2biphenylbiphenyl110Citrus fruitsB.3[Repealed, SOR/79-250, s. 4]
B.4bromophosO-(4-bromo-2, 5-dichlorophenyl) O,O-dimethyl phosphorothioate1.5ApplesB.5bromopropylateisopropyl 4,4′-dibromobenzilate2Citrus fruits, grapes10RaisinsB.6bromoxynil3,5-dibromo-4-hydroxybenzonitrile, including the metabolite 3,5-dibromo-4-hydroxybenzoic acid0.1Eggs, meat and meat by-products of cattle and poultry, milk, rapeseed (canola)C[Repealed, SOR/78-404, s. 4]
C.1A[Repealed, SOR/90-267, s. 1]
C.2captan3a,4,7,7a-tetrahydro-N-(trichloromethane-sulphenyl)-phthalimide5.0Apples, apricots, blueberries, cranberries, cherries, grapes, peaches/nectarines, pears, plums, raspberries, strawberries, tomatoesC.3carbaryl1-naphthyl methylcarbamate10Apricots, asparagus, beet tops, blackberries, boysenberries, cherries, Chinese cabbage, citrus fruits, collards, cranberries, dandelions, dewberries, endives, kale, lettuce, loganberries, mustard greens, nuts (whole in shells), okra, olives (raw), parsley, peaches/nectarines, plums, raspberries, salsify tops, spinach, Swiss chard, turnip tops, watercress7Blueberries, strawberries5Apples, bananas, beans, beet roots, broccoli, Brussels sprouts, cabbages, carrots, cauliflower, celery, eggplants, grapes, horseradish, kohlrabi, parsnips, pears, peas, peppers, poultry meat, radishes, salsify roots, tomatoes, turnip roots3Cucumbers, melons, pumpkins, squash2Barley, oats, rye, wheat1Corn, nuts (shelled)0.2PotatoesC.4carbofuran2,3-dihydro-2,2-dimethyl-7-benzofuranyl methylcarbamate including the metabolite 3-hydroxy carbofuran0.5Carrots, peppers, potatoes, rutabagas (turnips)0.4Strawberries0.3OnionsC.4.1carbofuran phenolic metabolites2,3-dihydro-2,2-dimethyl-7-hydroxybenzofuran, 2,3-dihydro-2,2-dimethyl-7-hydroxy-3-oxobenzofuran and 2,3-dihydro-2,2-dimethyl 3, 7-dihydroxybenzofuran1.0Carrots, potatoes, turnips0.5Onions, peppers, strawberriesC.5[Repealed, SOR/89-414, s. 1]
C.6chlordane1, 2, 4, 5, 6, 7, 8, 8-octachloro-3a, 4, 7, 7a-tetrahydro-4,7-methanoindan including the metabolite oxychlordane0.1Butter, cheese, milk and other dairy products; meat and meat by-products of cattle, goats, hogs, poultry and sheep.(Calculated on the fat content)C.6.1chlorimuron-ethylethyl 2-[[[[(4-chloro-6-methoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]benzoate0.05Soybeans C.7chlormequat(2-chloroethyl) trimethyl ammonium ion1.0WheatC.7.1chlorthal-dimethyldimethyl tetra-chloroterephthalate5Mustard greens, turnip greens2Beans, black-eyed peas, collards, kale, lettuce, peppers, pimentos, potatoes, soybeans, strawberries, sweet potatoes, turnips, yams1Broccoli, Brussels sprouts, cabbage, cantaloupes, cauliflower, cucumbers, eggplants, garlic, honeydew melons, onions, summer squash, tomatoes, watermelons, winter squashC.8[Repealed, SOR/92-65, s. 1]
C.9chlorothaloniltetrachloroisophthalonitrile, including the metabolite 4-hydroxy-2,5,6-trichloro-1,3-benzenedicarbonitrile15Celery5Beans, broccoli, Brussels sprouts, cabbage, cauliflower, cucumbers, melons, onions, pumpkins, beans, squash, tomatoes, wasabi2Cranberries1Carrots, mushrooms, parsnips0.6Blueberries0.5Cherries, peaches/nectarines0.3PeanutsC.10chlorprophamisopropyl 3-chlorophenylcarbamate15.0PotatoesC.10.1chlorpyrifosO,O-diethyl-O- (3,5,6-trichloro- 2-pyridyl) phosphorothioate 0.01 Apples, grapes, tomatoes C.10.1 O,O-Diéthyl-O- (3,5,6-trichloro- 2-pyridyl) phosphorothioate 0,01 Pommes, raisins, tomates O,O-diethyl-O- (3,5,6-trichloro- 2-pyridyl) phosphorothioate, including the metabolite 3,5,6- trichloro-2- pyridino0.01Apples, grapes, tomatoes2Kiwi fruit1Meat and meat by-products of cattle(calculated on the fat content)1Citrus fruits, fat, kidney and liver of cattle, peppers0.5RutabagasC.10.1.1clethodim(E,E)-(±)-2-[1-[[-3-chlor-2-propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, including metabolites containing the 2-cyclohex-1-enone moiety10Soybeans0.5Beans, chickpeas, lentils, peas (dry), potatoes0.4Mustard seed0.3Flaxseed0.2Onions, sunflower (including sunola) seeds0.05Rapeseed (canola)C.10.2clofentezine3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine including the metabolite 3-6(2-chloro-4-hydroxyphenyl)-6-(2-chlorophenyl)-1,2,4,5-tetrazine0.5Almonds, apples, pears1.0Peaches/nectarines0.01Milk0.05Meat and meat by-products (except liver) of cattle, goats, hogs, horses and sheepC.10.3clomazone2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one0.05SoybeansC.10.4clopyralid3,6-dichloro-2-pyridinecarboxylic acid7Barley, oats and wheat milling fractions, excluding flour2Barley, oats, wheat1Broccoli, cabbage, cauliflower, Chinese broccoli, Chinese mustard cabbage, kohlrabi, Napa Chinese cabbage, strawberries0.36Kidney of cattle, goats, horses and sheep0.2Flax, kidney of poultry0.05Eggs; fat, meat and meat by-products of cattle, goats, hogs, horses, poultry and sheep; kidney of hogs 0.01MilkC.10.5cloransulammethylmethyl 3-chloro-2-[[(5-ethoxy-7-fluoro[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)sulfonyl]amino]benzoate, including the metabolite 3-chloro-2-[[(5-ethoxy-7-fluoro[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)sulfonyl]amino]benzoic acid, calculated as ester0.01SoybeansC.10.6clothianidin[C(E)]-N-[(2-chloro-5-thiazolyl)methyl]-N′-methyl-N″-nitroguanidine0.01Field corn grain, milk, popcorn grain, rapeseed (canola), sweet corn kernel plus cob with husks removedC.11copper compoundscopper compounds (inorganic) including copper oxychloride, copper oxychloride-sulphate, copper sulphate, copper sulphate monohydrate, tribasic copper sulphate50.0Fresh fruits and vegetables(Calculated as copper)C.12coumaphos0-3-chloro-4-methylcoumarin-7-yl 0,0-diethyl phosphorothioate0.5Meat, meat by-products and fat of cattle, goats, horses, hogs, poultry and sheep(calculated on the fat content)C.134-CPA(p-chlorophenoxy) acetic acid2.0Mung bean sproutsC.13.01cyfluthrin(RS)-α-cyano-4-fluoro-3-phenoxybenzyl(1RS,3RS)-(1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate15Milk fat (in whole milk)5Fat of cattle, goats, hogs, horses, poultry and sheep0.5Milk0.4Meat and meat by-products of cattle, goats, hogs, horses, poultry and sheep0.01EggsC.13.1cyhalothrin-lambda[1α(S*),3α(Z)](±)-cyano(3-phenoxyphenyl)methyl 3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate2Head lettuce1Milk(calculated on the fat content)0.4Broccoli, cabbage0.3Sunflower oil0.2Meat of cattle, goats, hogs, horses and sheep, sunflower seeds0.15Corn flour, leeks0.1Tomatoes0.05CornC.14cymoxanil2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) acetamide0.05Fat, meat and meat by-products of cattle, goats, hogs and sheep, milk, potatoesC.15[Repealed, SOR/88-633, s. 1]
C.16cypermethrin(RS)-α-cyano-3-phenoxybenzyl (1RS, 3RS)-(1RS, 3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate1.0Apples, celery, citrus fruits0.5Beans, broccoli, Brussels sprouts, cabbage, cauliflower, grapes, pears0.3Tomatoes0.2Peaches/nectarines, strawberriesC.16.1cyprodinile4-cyclopropyl-6-methyl-N-phenylpyrimidin-2-amine3Raisins2Grapes, stone fruit0.1Pome fruit0.02AlmondsC.17cyromazineN
-cyclopropyl-1,3,5-triazine-2,4,6-triamine, including the metabolite 1,3,5-triazine-2,4,6-triamine10.0 Celery, leaf lettuce, spinach8.0Mushrooms4.0Head lettuce3.0Onions (green), peppers1.5Dry potato products1.0Cucumbers, melons, tomatoes0.5Potatoes0.3Onions (dry)D.12,4-D(2,4-dichlorophenoxy) acetic acid5Asparagus2Citrus fruits0.5CranberriesD.2[Repealed, SOR/91-443, s. 1]
D.2.1daminozidesuccinic acid mono(2,2-dimethylhydrazide), including the metabolite 1,1-dimethylhydrazine0.02All food cropsD.3DDT1,1,1-trichloro-2,2-bis(chlorophenyl)ethane including the metabolites 1,1-dichloro-2,2-bis(p-chlorophenyl)ethane (TDE or DDD) and 1,1-dichloro-2,2-bis(p chlorophenyl)ethylene (DDE)5.0Fish1.0Butter, cheese, milk and other dairy products; meat, meat by-products and fat of cattle, hogs, poultry and sheep(Calculated on the fat content)0.5Eggs, fresh vegetablesD.4[Repealed, SOR/79-250, s. 9]
D.5[Repealed, SOR/91-288, s. 1]
D.6[Repealed, SOR/83-265, s. 2]
D.7diazinonO, O-diethyl-O-(2-isopropyl- 6-methyl-4-pyrimidinyl) phosphorothioate0.75Apples, apricots, beets, broccoli, cabbage, carrots, cauliflower, celery, cherries, endives, grapes, kale, kohlrabi, lettuce, onions, pears, peppers, plums, salsify, spinach, strawberries, tomatoes, turnips tops, wasabi0.7Citrus fruits, peaches/nectarines0.5Beans, Brussels sprouts, cucumbers, turnips0.25Cantaloupes, collards, cranberries, figs, hops, lima beans, muskmelons, parsley, parsnips, radishes, summer squash, Swiss chard, watermelons, winter squashD.8[Repealed, SOR/79-250, s. 11]
D.9dichlone2, 3-dichloro-1, 4-naphthoquinone3Apples, cherries, peaches/nectarines, plums, prunes15StrawberriesD.10dichloran2,6-dichloro-4-nitroaniline20Snap beans15Peaches/nectarines, sweet cherries10Apricots, blackberries, celery, grapes, lettuce, raspberries, strawberries5Carrots, onions, plums, rhubarb, sweet potatoes, tomatoes0.5Cucumbers, garlicD.11dichlorvos2, 2-dichlorovinyl dimethyl phosphate0.25Tomatoes0.50Non-perishable packaged foods of low fat content (under 6%)2.0Non-perishable packaged foods of high fat content (over 6%)D.12dicofol1, 1-bis(ϱ-chlorophenyl) 2, 2, 2-trichloroethanol5.0Citrus fruits3.0Almonds, apples, apricots, beans, blackberries, boysenberries, cantaloupes, cherries, chestnuts, cucumbers, dewberries, eggplants, figs, filberts, grapes, hickory nuts, honeydew melons, loganberries, muskmelons, peaches/nectarines, pears, peas, pecans, peppers, pimentos, plums, pumpkins, quinces, raspberries, soybeans, strawberries, summer squash, tomatoes, walnuts, watermelons, winter squash0.1Butter, cheese, milk and other dairy products, meat and meat by-products of cattle, goats, hogs, poultry and sheep(calculated on the fat content)D.13dieldrin see aldrinD.14difenoconazole1-[2-[4-(4-chlorophenoxy)-2-chlorophenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole0.1Wheat0.05Eggs, meat and meat by-products of cattle, goats, hogs, poultry and sheep, mustard seed0.03Rapeseed (canola)0.01Barley, field corn grain, milk, sweet corn kernel plus cob with husks removedD.14.1diflufenzopyr2-[1-[[[(3,5-difluorophenyl)amino] carbonyl]hydrazono]ethyl]-3-pyridinecarboxylic acid including its metabolites convertible to M1 (8-methyl-5(6H)-pyrido[2,3-d] pyridazinone)0.05CornD.14.2dimethenamid2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy-1-methylethyl) acetamide 0.01Onions (dry bulb)D.15dimethoateO, O-dimethyl S-(N-methyl-carbamoyl-methyl) phosphorodithioate including the metabolite omethoate2.0Apples, beet greens, broccoli, cabbages, cauliflower, cherries, kale, lettuce, pears, spinach, Swiss chard, turnip greens1.5Citrus fruits1.0Beans, blueberries, celery, strawberries0.5Peas, peppers, tomatoesD.16dimethomorph(E,Z)-4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine0.01PotatoesD.17diphenamidN, N-dimethyl-2, 2-diphenylacetamide1StrawberriesD.18diphenylaminediphenylamine5.0ApplesD.18.1diquat9,10-dihydro-8a, 10a- diazon- iaphenanthrene ion0.5Flax, solin0.2Lentils0.05Eggs, meat and meat by-products, milk, poultry meat and poultry meat by-productsD.19disulfotonO, O-diethyl S-[2-(ethylthio)-ethyl] phosphorodithioate0.2Potatoes0.5Beans, broccoli, Brussels sprouts, cabbage, cauliflower, lettuce, peas, spinach, tomatoesD.21diuron3-(3, 4-dichloro-phenyl)-1, 1-dimethylurea1Citrus fruits, corn, grapes, pineapples, potatoes, wheat7AsparagusD.22dodineη-dodecylguanidine acetate5.0Apples, pears, strawberries2.0CherriesD.23[Repealed, SOR/79-250, s. 12]
E.1endosulfan6, 7, 8, 9, 10, 10-hexachloro-1, 5, 5a, 6, 9, 9a-hexahydro-6, 9-methano-2, 4, 3-benzodioxathiepin 3-oxide, including the metabolite endosulfan sulfate2.0Apples, apricots, broccoli, Brussels sprouts, cabbage, cherries, lettuce, peaches/nectarines, pears, plums, spinach1.0Artichokes, beans, cauliflower, celery, cucumbers, eggplants, grapes, melons, peppers, pumpkins, squash, strawberries, tomatoes, watercress0.5Peas0.1Butter, cheese, milk and other dairy products; meat and meat by-products of cattle, goats, hogs, poultry and sheep(calculated on the fat content)E.1.1endrin1,2,3,4,10,10-hexachloro-6,7-epoxy-1,4,4a,5,6,7,8, 8a-octahydro-endo-endo-1,4,5,8-dimethanonaphthalene0.02Butter, cheese, milk and other dairy products.(calculated on the fat content)E.2ethephon2-Chloroethyl phosphonic acid7Apples, broccoli, Brussels sprouts, cabbage, cauliflower, eggplants, endives, grapes, lettuce, mushrooms, onions (green), pears, peppers6Lentils5Celery4Cucumbers, tomatoes0.5Onions (dry)E.3ethionO, O, O′, O′-tetraethyl S, S’-methylene bisphosphorodithioate2.5Meat, meat by-products and fat of cattle(calculated on the fat content)2.0Apples, citrus fruits, grapes, pears1.0Beans, peaches/nectarines, plums, strawberries0.5TomatoesE.4ethoxyquin1,2-dihydro-6-ethoxy-2,2,4-trimethyl-quinoline polymer0.5Eggs, meat, poultry meat3Apples, pears, poultry fat, liver of poultryE.5ethylenebisdi- thiocarbamate fungicidesmanganese and zinc ethylenebis (dithiocarbamate) (polymeric)7Apples, broccoli, Brussels sprouts, cabbage, cauliflower, eggplants, endives, grapes, lettuce, mushrooms, onions (green), pears, peppers6Lentils5Celery4Cucumbers, tomatoes0.5Onions (dry)F.01famoxadone5-methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-2,4-oxazolidinedione1.0Tomatoes0.06Milk fat0.05Liver of cattle, goats, horses and sheep0.02Fat of cattle, goats, horses and sheep; potatoesF.02fenamidone(5S)-3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-4H-imidazol-4-one 0.02PotatoesF.03fenbuconazoleα-[2-(4-chlorophenyl)ethyl]-α-phenyl-1H-1,2,4-triazole-1-propanenitrile, including the metabolites cis-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazol-1-ylmethyl)-2-3H-furanone and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazol-1-ylmethyl)-2-3H-furanone0.8Sour cherries, sweet cherries0.5Dried prune plums, peaches/ nectarines0.3Apricots0.1Plums, prune plums F.1fenbutatin oxidedi [tri-(2-methyl-2-phenylpropyl) tin] oxide3.0Apples, pears2.0Citrus fruits0.5Cucumbers, tomatoesF.1.001fenhexamidN-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexanecarboxamide20Blackberries, loganberries, raspberries6Apricots, cherries, peaches/nectarines, raisins4Grapes3Strawberries0.5Plums0.02AlmondsF.1.01fenoxapropethyl(RS
)-ethyl-2-[4-(6-chloro-1,3-benzoxazol-2-yloxy)-phenoxy]propanoate including the metabolites 2-[4-[(6-chloro-2-benzoxazolyl)-oxy]phenoxy]propionic acid and 6-chloro-2,3-dihydrobenzoxalazol-2-one0.02MilkF.1.1ferbamferric dimethyldithiocarbamate7Apples, apricots, asparagus, beans, beets, blackberries, blackeyed peas, blueberries, broccoli, Brussels sprouts, cabbage, carrots, cauliflower, celery, cherries, collards, corn, cranberries, cucumbers, currants, dates, eggplants, gooseberries, grapes, guavas, huckleberries, kale, kohlrabi, lettuce, loganberries, mangoes, melons, mustard greens, onions, papayas, peaches/nectarines, peanuts, pears, peas, peppers, plums, (fresh prunes), pumpkins, quinces, radishes, raspberries, rutabagas, spinach, squash, strawberries, summer squash, tomatoes, turnips(Calculated as zineb)F.1.1.01florasulamN-(2,6-difluorophenyl)-8-fluoro-5-methoxy[1,2,4]triazolo[1,5-c]pyrimidine-2-sulphonamide0.01Barley, oats, wheatF.1.1.1fluazifop-butylbutyl(±)-2-[4-[[5-(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate1Soybeans, strawberries(calculated as acid)0.3Mustard(calculated as acid)0.2Flax, solin(calculated as acid)0.1Blueberries(calculated as acid)0.05Eggs; fat, meat and meat by-products of cattle, goats, hogs, horses, poultry and sheep(calculated as acid)0.01Milk(calculated as acid)F.1.1.2fluazuron1-[4-chloro-3-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenyl]-3-(2,6-difluorobenzoyl) urea7.0Fat of cattle0.5Meat by-products of cattleF.1.1.3flucarbazone-sodium4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-[[2-(trifluoromethoxy) phenyl]sulfonyl]-1H-1,2,4-triazole-1-carboxamide, sodium salt, including the metabolite 4,5-dihydro-3-methoxy-5-oxo-N-[[2-(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole-1-carboxamide, sodium salt0.01WheatF.1.2flucythrinate(RS)-a-cyano-3-phenoxybenzyl (S)-2-(4-difluoromethoxyphenyl)-3-methylbutyrate0.1Milk(calculated on the fat content)F.1.2.1fludioxonil4-(2,2-difluoro-1,3-benzodioxol-4-yl) 1H-pyrrole-3-carbonitrile7Onions (green)2Apricots, peaches/nectarines, plums, strawberries1Grapes0.2Onions (dry bulb)0.05Fat, kidney and liver of cattle, goats, hogs, horses and sheep; mustard0.02Potatoes0.01Meat of cattle, goats, hogs, horses and sheep; milk; rapeseed (canola)F.1.3flusilazolebis(4-fluorophenyl)(methyl)(1H-1,2,4-triazole-1-ylmethyl)silane1Raisins0.5Grapes0.2Apples0.1Bananas0.01*Meat and meat by-products of cattle; milk* includes flusilazole,bis(4-fluorophenyl)(methyl)silanol and 1H-1,2,4-triazoleF.2folpetN-(trichloromethylthio)phthalimide30Celery25Apples, avocados, blackberries, blueberries, boysenberries, cherries, crabapples, cranberries, currants, dewberries, gooseberries, grapes, huckleberries, leeks, lettuce, loganberries, onions, raspberries, strawberries, tomatoes15Citrus fruits, cucumbers, garlic, melons, pumpkins, squashF.2.1fomesafen5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide0.05Dry beans, lima beans, snap beans, soybeansF.2.1.1foramsulfuron2-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]-4-(formylamino)-N,N-dimethylbenzamide0.01Field corn grainF.3formetanate hydrochloridem-[[(dimethylamino) methylene] amino] phenyl methylcarbamate hydrochloride4.0Citrus fruits3.0Apples, peaches/nectarines, pears0.5PlumsF.4[Repealed, SOR/97-411, s. 1]
F.5fosetyl-aluminumaluminum tris(Q
-ethylphosphonate)100Celery, lettuce, spinach75Strawberries60Bok choy cabbage, broccoli, cabbage, cauliflower, Chinese broccoli, mustard greens15Cantaloupes, cucumbers, squash10Avocados3Tomatoes1Apples0.5Onions (dry)G.1glufosinate - ammoniumammonium(+)-2-amino-4-(hydroxymethylphosphinyl)butanoate, including the metabolite propanoic acid, 3-(hydroxymethylphosphinyl)6Lentils3.5Cottonseed oil3Dry peas, rapeseed (canola)2Soybeans1Liver and kidney of cattle, goats, hogs, poultry and sheep; rice0.5Dry white beans0.4Potatoes0.2Corn, wheat0.1Eggs; fat, meat and meat by products of cattle, goats, hogs, poultry and sheep0.4MilkG.2glyphosateN-(phosphono-methyl) glycine, including the metabolite amino-methylphosphonic acid35Oat milling fractions, excluding flour20Soybeans15Barley and wheat milling fractions, excluding flour, oats10Barley, rapeseed (canola), sugar beets5Peas, wheat4Beans, lentils3Corn, flax2Kidney of cattle, goats, hogs, poultry and sheep0.5Asparagus0.2Liver of cattle, goats, hogs, poultry and sheepG.3[Repealed, SOR/89-414, s. 2]
G.4[Repealed, SOR/93-243, s. 2]
H.1heptachlor1, 4, 5, 6, 7, 8, 8-heptachloro-3a, 4, 7, 7a-tetrahydro-4, 7-methanoindene including the metabolite heptachlor epoxide0.2Meat, meat by-products and fat of cattle, goats, hogs, poultry and sheep(calculated on the fat content)0.1Butter, cheese, milk and other dairy products(calculated on the fat content)H.2hydrogen cyanidehydrocyanic acid25Almonds, barley, cashew nuts, cocoa beans, corn, kidney beans, lima beans, navy beans, peanuts, pecans, rice, rye, walnuts, wheatI.1iprodione3-(3,5-dichlorophenyl)-N-isopropyl-2,4-dioxoimidazolidine-1-carboxamide including the metabolites 3-isopropyl-N-(3,5-dichlorophenyl)-2,4-dioxoimidazolidine-1-carboxamide and 3-(3,5-dichlorophenyl)-2,4-dioxoimidazolidine-1-carboxamide60Raisins15Lettuce10Grapes, peaches/nectarines, raspberries5Carrots, cherries, strawberries, wine3Apricots2Plums, prunes1Rapeseed (canola)0.5Cucumbers, kiwi fruit (edible portion), tomatoes0.3BeansI.2imazalil1-(ß-allyloxy-2,4-dichlorophenethyl) imidazole5.0Citrus fruitsI.2.01imazamox2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(methoxymethyl)-3-pyridinecarboxylic acid0.1Soybeans0.05Peas, rapeseed (canola), wheat0.01Eggs, meat and meat by-products of cattle, goats, horses, poultry and sheep, milkI.2.02imazethapyr(±)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-ethyl-3-pyridinecarboxylic acid, expressed as ammonium salt0.1Kidney beans, lima beans, navy beans, pinto beans, runner beans, snap beans, soybeans, tepary beans, wax beansI.2.1imidacloprid1-[(6-chloro-3-pyridinyl)methyl]-4,5-dihydro-N-nitro-1H-imidazol-2-amine, including metabolites containing the 6-chloropicolyl moiety6Tomato paste3.5Brassica crops, lettuce3Sour cherries, sweet cherries, tomato purée1.5Grapes1Blueberries, citrus fruits, peppers, tomatoes0.6Pears0.5Apples, cucumbers0.3Potatoes0.2Mangoes0.08Eggsplants0.05Cottonseed oil, field corn grain, mustard seed, pecans, rapeseed (canola), sweet corn kernel plus cob with husks removedI.2.11iodosulfuron-methyl-sodium4-iodo-2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]benzoic acid methyl ester, monosodium salt0.025Field corn grainI.2.2iprovalicarb[2-methyl-1[[[(1S)-(4-methylphenyl)ethyl]amino]carbonyl]propyl]carbamic acid methylethylester2GrapesI.3isofenphosO
-ethylO
-2-isopropoxy-carbonylphenyl isopropylphos- phoramidothioate including the metabolites 1-methylethyl-2-[[ethoxy[(1-methylethyl) amino] phosphinoxy]oxy] benzoate, 1-methylethyl-2-[[ethoxy(1-amino)phosphino-thioyl]oxy] benzoate and 1-methylethyl-2-[[ethoxy(1-amino) phosphinoxy]oxy] benzoate0.01Milk0.02Eggs, rapeseed (canola)I.3.1isoxadifen-ethylethyl 4,5-dihydro-5,5-diphenyl-3-isoxazolecarboxylate0.08Field corn grainI.4isoxaflutole(5-cyclopropyl-4-isoxazoly)[2-(methylsulfonyl)-4-(trifluoromethyl)phenyl]methanone, including the metabolite 1-(2-methylsulfonyl-4-trifluoromethylphenyl)-2-cyano-3-cyclopropylpropane, as parent equivalent0.5Liver of cattle0.3Liver of poultry0.2Meat of cattle, hogs, horses, poultry and sheep0.1Meat by-products of cattle, hogs, horses, poultry and sheep0.02Milk0.01Eggs(5-cyclopropyl-4-isoxazoly)[2-(methylsulfonyl)-4-(trifluoromethyl)phenyl] methanone, including the metabolites 1-(2-methylsulfonyl-4-trifluoromethylphenyl)-2-cyano-3-cyclopropylpropane and 2-methylsulfonyl-4-trifluoromethyl benzoic acid, as parent equivalent0.2CornK.1kresoxim-methylmethyl (aE)-a-(methoxyimino)-2-[(2-methylphenoxy)methyl] benzeneacetate, including the metabolites (E)-2-[2-(2-methylphenoxymethyl)phenyl]-2-methoxyiminoacetic acid, 2-[2-(2-hydroxymethylphenoxymethyl)phenyl]-2-methoxyiminoacetic acid and 2-[2-(4-hydroxy-2-methylphenoxymethyl)phenyl]-2-methoxyiminoacetic acid1.5Raisins1Grapes0.5Apples, crabapples, loquats, mayhaws, oriental pears, pears, quinces0.15Apple juice, pear juice, pecans0.03Meat and meat by-products of cattle, goats, hogs, horses and sheep0.004MilkL.1lindanegamma isomer of benzene hexachloride (BHC)3.0Apples, apricots, asparagus, avocados, broccoli, Brussels sprouts, cabbage, cauliflower, celery, cherries, collards, cucumbers, eggplants, grapes, guavas, kale, kohlrabi, lettuce, mangoes, melons, mushrooms, mustard greens, okra, onions, peaches/nectarines, pears, peppers, pineapples, plums, pumpkins, quinces, spinach, squash, strawberries, Swiss chard, tomatoes2.0Meat, meat by-products and fat of cattle, goats, hogs and sheep(calculated on the fat content)0.7Meat and meat by-products of poultry(calculated on the fat content)0.2Butter, cheese, milk and other dairy products(calculated on the fat content)L.3[Repealed, SOR/84-301, s. 1]
M.1malathiondiethyl mercaptosuccinate S-(O,O-dimethyl phosphorodithioate)8Apricots, avocados, blackberries, blueberries, boysenberries, cranberries, currants, dewberries, gooseberries, grapes, loganberries, melons, mushrooms, papayas, pecans, peppermint, pineapples, plums, raisins, raspberries, raw cereals, spearmint, strawberries6Asparagus, Brussels sprouts, cabbage, cherries, dandelions, endives, kale, lettuce, parsley, peaches/nectarines, spinach, watercress3Cucumbers, leeks, lentils, okra, onions (green), pumpkins, salsify, shallots, squash, tomatoes2Apples, beans, pears, whole meal and flour from wheat and rye1Celery0.5Beets, broccoli, carrots, cauliflower, collards, eggplants, garlic, horseradish, kohlrabi, onions (dry), parsnips, peas, peppers, potatoes, radishes, Swiss chard, turnips (rutabagas)M.2maleic hydrazide1, 2-dihydro-3, 6-pyridazinedione15Onions30Beets, carrots, rutabagas50PotatoesM.2.1mesotrione2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione0.01Eggs; field corn grain; meat and meat by-products of cattle, goats, hogs, horses, poultry and sheep; milk; sweet corn kernel plus cob with husks removedM.3metalaxylN-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alanine methyl ester, including metabolites containing the 2,6-dimethylaniline moiety10Onions (green), spinach7Asparagus5Citrus fruits, endives, lettuce4Avocados3Ginseng, onions (dry)2Blueberries, broccoli, cabbage, cauliflower, raisins1Apricots, cantaloupes, cherries, cucumbers, grapes, peaches/nectarines, peppers, plums, soybeans, squash, sugar beets, tomatoes, watermelons0.5Almonds, carrots, potatoes, radishes, walnuts0.4Strawberries0.2Beans, peanuts, peas, raspberries, wheat0.05BarleyM.4methamidophosO,S-dimethyl phosphoramidothioate1.0Broccoli, Brussels sprouts, lettuce, peppers0.5Cabbage, cauliflower, celery, cucumbers, eggplants, tomatoes0.3BeansM.5methidathionS-(2,3-dihydro-5-methoxy-2-oxo-1,3,4-thiadoxol-3-ylmethyl) O,O-dimethylphosphorodithioate2.0Citrus fruits0.5Apples, pears0.2Cherries, grapes, peaches/nectarines, plumsM.6methomylS
-methyl-N
-(methylcarbamoyloxy) thioacetimidate6.0Blueberries5.0Cabbages4.0Grapes2.0Lettuce1.0Citrus fruits, strawberries0.5Apples, celeryM.6.1(S)-methoprene1-methylethyl (E,E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate0.05MushroomsM.7methoxychlor1,1,1-trichloro-2,2-di-(4-methoxyphenyl)ethane14.0Apples, apricots, asparagus, beans, beets, blackberries, black-eyed peas, blueberries, broccoli, Brussels sprouts, cabbage, carrots, cauliflower, cherries, collards, corn (in the husk), cranberries, cucumbers, currants, eggplants, gooseberries, grapes, kale, kohlrabi, lettuce, loganberries, melons, mushrooms, peaches/nectarines, peanuts, pears, peas, peppers, pineapples, plums, pumpkins, quinces, radishes, raspberries, spinach, squash, strawberries, summer squash, tomatoes, turnips (rutabagas)3.0Meat, meat by-products and fat of cattle, hogs and sheep(calculated on the fat content)2.0Barley, corn (as grain), oats, rice, rye, soybean, wheatM.7.1methoxyfenozide3-methoxy-2-methylbenzoic acid, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide1.5Apples, crabapples, loquats, mayhaws, oriental pears, pears, quinces0.1Fat, meat and meat by-products of cattle, goats, hogs, horses and sheep3-methoxy-2-methylbenzoic acid, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide, including the metabolite ß-D-Glucopyranuronic acid, 3-{[2-(1,1-dimethylethyl)-2-(3,5-dimethylbenzoyl)-hydrazino]carbonyl}-2-methylphenyl-0.1Kidney and liver of cattle, goats, hogs, horses and sheepM.7.1.11- methylcyclopropene1- methylcyclopropene0.01ApplesM.7.2S-metolachlor2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(IS)-2-methoxy-1-methylethyl)acetamide and 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(IR)-2-methoxy-1-methylethyl)acetamide, including the metabolites 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone0.3Dry beans, lima beans, peas, snap beans0.2Kidney of cttle, potatoes, soybeans0.1Apples, apricots, cherries, corn, peaches/nectarines, pears, plums, rutabagas, sugar beets, tomatoes0.05Liver of cattle and poultry0.02Eggs, meat of cattle, goats, hogs, poultry and sheep, milkM.8metribuzin4-amino-6-tert-butyl-3-methylthio-4,5-dihydro-1,2,4-triazin-5-one including the metabolites 6-tert-butyl-3-methylthio-4,5-dihydro-1,2,4-triazin-5-one,4-amino-6-tert-butyl-2,-3,4,5-tetrahydro-1,2,4-triazin-3,5-dione and 6-tert-butyl-2,3,4,5-tetrahydro-1,2,4-triazin-3,5-dione0.5PotatoesM.8.1metsulfuron-methylmethyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbony] amino]sulfonyl]benzoate, including the metabolite methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl] 4-hydroxybenzoate0.5Kidney of cattle, goats and hogs0.1Fat, meat and meat by-products of cattle, goats and hogs0.05MilkM.9mevinphosmethyl 3-hydroxy-crotonate dimethyl phosphate0.25Apples, asparagus, broccoli, Brussels sprouts, cabbage, cauliflower, celery, collards, kale, lettuce, mustard greens, onions (green), pears, peaches/nectarines, plums, raspberries, spinach, strawberries, tomatoes, turnip tops0.2Citrus fruitsM.10monocrotophosdimethyl cis-1-methyl-2-methylcarbamoylvinyl phosphate1.0Apples0.5Pears, tomatoesM.11myclobutanilα-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile, including the metabolites α-(3-hydroxybutyl)-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile and α-(butyl-3-one)-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile10Raisins7Dried peaches/nectarines4Dried cherries2Bananas1Cherries, grapes, peaches/nectarines, peppers0.5Apples, strawberries0.3Balsam apples, balsam pears, bitter melons, cantaloupes, casaba melons, chayotes, Chinese cucumbers, Chinese waxgourds, citron melons, crenshaw melons, cucumbers, golden pershaw melons, gourds (edible), honey balls, honeydew melons, mango melons, Persian melons, pineapple melons, pumpkins, Santa Claus melons, snake melons, summer squash, watermelons, winter squashα-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile, including the metabolites α-(3-hydroxybutyl)-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile, α-(butyl-3-one)-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile and α-(4-chlorophenyl)-α-(2-formylethyl)-1H-1,2,4-triazole-1-propanenitrile0.3Liver of cattle, goats, hogs, horses and sheep0.05Fat, meat and meat by-products of cattle, goats, hogs, horses and sheep, milk0.02Eggs, fat, meat and meat by-products of poultryN.1naled1,2-dibromo-2,2-dichloro-ethyl dimethyl phosphate3Chard, citrus fruits, spinach, turnip tops1Broccoli, Brussels sprouts, cabbage, cauliflower, lettuce, strawberries0.5Beans, cucumbers, eggplants, melons, peas, peppers, pumpkins, rice, soybeans, squash, tomatoesN.1.1nicosulfuron2[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino] sulfonyl]-N,N-dimethyl-3-pyridinecarboxamide0.1Corn0.05BlueberriesN.2nicotinei-1-methyl-2-(3-pyridyl) pyrrolidine2Apples, apricots, artichokes, asparagus, beans, beets, beet tops, blackberries, black-eyed peas, boysenberries, broccoli, Brussels sprouts, cabbage, cantaloupes, cauliflower, celery, cherries, collards, corn, cucumbers, eggplants, grapefruit, green beans, onions (green), kale, kohlradi, lemons, lettuce, lima beans, limes, mushrooms, muskmelons, mustard greens, okra, onions, oranges, parsley, parsnips, peaches/nectarines, pears, peas, peppers, pimentos, plums, prunes, pumpkins, quinces, radishes, rutabagas, snap beans, spinach, summer squash, Swiss chard, tangerines, tomatoes, turnips, watermelons, winter squashO.1oxyfluorfen2-chloro-α, α, α-trifluoro-p-tolyl 3-ethoxy-4-nitrophenyl ether0.05StrawberriesP.1paraformal-dehydeparaformaldehyde2Maple syrup(Calculated as formal-dehyde)P.2parathionO, O-diethyl O-p-nitrophenyl phosphorothioate0.7Beans, red beets, broccoli, Brussels sprouts, cabbage, carrots, cauliflower, celery, corn, cucumbers, eggplants, endives, kale, kohlrabi, lettuce, onions, parsnips, peas, peppers, pumpkins, radishes, spinach, squashes, Swiss chard, tomatoes, turnips1.0Apples, apricots, blackberries, blueberries, cherries, citrus fruits, cranberries, currants, gooseberries, grapes, hops, loganberries, melons, peaches/nectarines, pears, plums, quinces, raspberries, strawberriesP.2.1permethrin3-phenoxyphenyl) 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate20Leaf lettuce, spinach10Head lettuce5Celery2Grapes1Apples, peaches/nectarines, pears0.5Beans, broccoli, Brussels sprouts, cabbage, cucumbers, peppers, plums, tomatoes, wasabi0.2Milk and other dairy products(calculated on the fat content)0.1Fat, meat and meat by-products of cattle and poultry(calculated on the fat content)P.3[Repealed, SOR/80-499, s. 9]
P.4phosaloneO,O-diethyl S-(6-chloro-benzo- xazolin-3-yl)-methyl phosphorodithioate15.0Artichokes12.0Dried apricots6.0Cherries5.0Apples, grapes, plums4.0Apricots, peaches/nectarines2.0Pears1.5Citrus fruitsP.4.1phosmetO,O-dimethyl phthalimidomethyl phosphorodithioate10.0Apples, grapes, peaches/nectarines, pears7.0Cherries5.0Blueberries, plums1.0Kiwi fruit (edible portion)P.4.1.1picloram4-amino-3,5,6-trichloropicolinic acid0.4Kidney and meat by-products of cattle, goats, hogs, horses and sheep0.2Kidney and meat by-products of poultry; wheat0.1Barley0.05Eggs; fat, liver and meat of cattle, goats, hogs, horses, poultry and sheep; milkP.4.2picolinafenN-(4-fluorophenyl)-6-[3-(trifluoromethyl)phenoxy]-2-pyridinecarboxamide0.05Barley, wheatP.5piperonyl butoxideα[2-(2-butoxyethoxy) ethoxy] -4,5-(methylene-dioxy)-2-pro- pyltoluene20Raw cereals8Almonds, apples, beans, blackberries, blueberries, boysenberries, cherries, cocoa beans, copra, crabapples, currants, dewberries, figs, gooseberries, grapes, guavas, huckleberries, loganberries, mangoes, muskmelons, oranges, peaches/nectarines, peanuts, pears, peas, pineapples, plums, raspberries, tomatoes, walnutsP.5.1pirimicarb2-(dimethylamino)-5,6 dimethyl pyrimidin-4-yl dimethylcarbamate including the metabolites 2-(formyl methylamino)-5,6-dimethyl pyrimidin-4-yl dimethylcarbamate and 2-(methylamino)-5,6-dimethyl pyrimidin-4-yl dimethylcarbamate0.5Apples0.2Spinach0.1CeleryP.5.1.1primisulfuron-methyl2-[4,6-bis(difluoromethoxy) pyrimidin-2-ylcarbamoylsulfamoyl] benzoic acid, methyl ester0.1Eggs, meat and meat by-products of cattle, goats, hogs, horses, poultry and sheep0.02Corn, milkP.5.2procymidoneN
-(3,5-dichlorophenyl)- 1,2-dimethylcyclopropane- 1,2-dicarboximide25.0Raisins5.0Grapes1.0WineP.6propargite2-(4-tert-butyl-phenoxy) cyclohexylprop-2-ynyl sulphite30.0Hops (dried)7.0Apricots, grapes, peaches/nectarines, strawberries5.0Beans, citrus fruits, cranberries, plums3.0Apples, pearsP.6.1Propamocarb hydrochloridepropyl [3-(dimethylamino)propyl]carbamate hydrochloride2Cucumbers0.5PotatoesP.7propiconazole1-[[2-(2,4-diclorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole including all metabolites containing the 2,4-dichlorophenyl-1-methyl substituted moiety2Liver and kidney of cattle1Apricots, cherries, peaches/nectarines, plums0.15Dried blueberries0.1Asparagus0.05Barley, oats, wheat0.02BlueberriesP.7.1propyzamide3,5-dichloro-N
-(1,1-dimethylpropynl)-benzamide including its metabolites containing the 3,5-dichlorobenzoate moiety1.0LettuceP.7.2prosulfuron1-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoro-propyl)phenylsulfonyl]urea0.05Eggs, meat and meat by-products0.01Corn, milkP.8pyrethrins4-hydroxy-3-methyl-2-(2,4- pentadienyl)-2-cyclopenten-1- one 2,2-dimethyl-3-(2-methyl- propenyl) cyclopropane-carboxylate3Raw cereals1Almonds, apples, beans, blackberries, blueberries, boysenberries, cherries, cocoa beans, copra, crabapples, currants, dewberries, figs, gooseberries, grapes, guavas, huckleberries, loganberries, mangoes, muskmelons, oranges, peaches/nectarines, peanuts, pears, peas, pineapples, plums, raspberries, tomatoes, walnutsand4-hydroxy-3-methyl-2-(2,4- pentadienyl)-2-cyclopenten- 1-one 1-methyl 3-carboxy-α, 2, 2-trimethylcyclopropane- acrylate esterP.8.01pyridaben4-chloro-2-(1,1-dimethylethyl)-5-[[[4-(1,1-dimethylethyl) phenyl]methyl]thio]-3 (2H)-pyridazinone2Strawberries1.5Peaches/nectarines1Peppers0.75Pears0.5Apples0.3Grapes0.15Tomatoes0.1Cucumbers0.05Almonds, meat of cattle, goats, horses and sheep0.01MilkP.8.1pyrimethanil4,6-dimethyl-N-phenyl-2-pyrimidinamine8Raisins5Grapes0.05BananasQ.01quinclorac3,7-dichloroquinoline-8-carboxylic acid5Rice2Barley0.5Wheat0.05Eggs; meat, meat by-products and fat of cattle, goats, hogs, horses, poultry and sheep; milkQ.1quizalofop-ethylethyl (RS) 2-[4-(6-chloroquinoxalin-2-yloxy) phenoxy] propionate, including the acid metabolites of (RS)2-[4-(6-chloroquinoxalin-2-yloxy) phenoxy] propanoic acid, all expressed as quizalofop-ethyl0.2Sugar beets0.05Fat and meat by-products of cattle, goats, hogs, horses, poultry and sheep, flax, lentils, milk fat, peas, rapeseed (canola), soybeans0.02Eggs, meat of cattle, goats, hogs, horses, poultry and sheep0.01MilkR.1rimsulfuronN-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide0.05Blueberries, tomatoesS.1sethoxydim(±)-2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one and metabolites containing the cyclohexen-2-one moiety expressed as sethoxydim30Lentils15Tomato paste10Dry beans, peas, strawberries7Sunflowers5Beans, raspberries, soybeans4Blueberries, potatoes, tomatoes2Artichokes, cabbage, cantaloupes, cranberries, eggplants, eggs, mustard, mustard greens, spinach1Celery, cucumbers, lettuce, pumpkins, squash0.5Asparagus, broccoli, corn, peppers, liver of poultry0.2Flax, onions, meat of poultry, turnips0.1CarrotsS.2sodium ortho- phenyl phenateo
-phenyl phenol, sodium salt25*Apples, pears 20*Carrots, peaches/nectarines, plums15*Sweet potatoes10*Cantaloupes (edible portion), citrus fruits, cucumbers, peppers (bell), pineapples, tomatoes5*Cherries*(Calculated as orthophenylphenol)S.3sodium TCAsodium trichloroacetate0.5Barley, oats(Calculated as trichloroacetic acid)S.3.1spinosad(2R,3aS,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14, 16a,16b-tetradecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione (spinosyn A) and (2S,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14, 16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione (spinosyn D)0.1Apples0.02PotatoesS.4sulfosulfuronN-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-2-(ethylsulfonyl)imidazo[1,2-α]pyridine-3-sulfonamide and all metabolites containing the imidazopyridine moiety, expressed as sulfosulfuron0.02WheatT.001tebuconazole(±)-a-[2-(4-chlorophenyl)ethyl]-a-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol5Grapes3Cherries1Peaches/nectarines0.1Peanuts0.05Wheat0.03Bananas0.01Barley, oats(±)-a-[2-(4-chlorophenyl)ethyl]-a-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol, including the metabolite 5-(4-chlorophenyl)-2,2-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-1,3-pentanediol0.2Meat and meat by-products of cattle, goats, hogs, horses and sheep0.1Eggs, meat and meat by-products of poultry, milkT.01tebufenozide3,5-dimethylbenzoic acid 1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide6Lettuce5Dried cranberries2.5Raisins2Tomatoes1Apples, cranberries, pears0.5Grapes, kiwi fruit0.2PeppersT.1.0tefluthrin2,3,5,6-tetrafluoro-4-methylbenzyl (Z)-(1RS)-cis-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate, including metabolites containing the cis-3-(Z-2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate moiety0.001MilkT.1.1tetrachlorvinphos2-chloro-1-(2,4,5-trichlorophenyl) vinyl dimethyl phosphate and its low melting isomer10Apples, grapes1.5Meat, meat by-products and fat of cattle and hogs(calculated on the fat content)0.75Meat, meat by-products and fat of poultry(calculated on the fat content)T.1.2tetradifon4-chlorophenyl 2, 4, 5-tri- chlorophenyl sulphone1Cucumbers, melons, pumpkins, summer squash, tomatoes, watermelons, winter squash2Citrus fruits5Apples, crabapples, apricots, cherries, grapes, peaches/nectarines, pears, plums, prunes, quinces, strawberries10Figs100Peppermint, spearmintT.2thiabendazole2-(4-thiazolyl) benzimidazole10Apples, citrus fruits, pears4.0Potatoes0.4Bananas (edible pulp)T.2.01thiamethoxam3-[(2-chloro-5-thiazolyl)methyl] tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-imine, including the metabolite (E)-N-[(2-chloro-5-thiazolyl)methyl]-N’-methyl-N”-nitro-guanidine0.02All food crops, eggs, meat and meat by-products of cattle, hogs, poultry and sheep0.01MilkT.2.1thifensulfuron-methylmethyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate0.07Tomatoes0.02Flax, rapeseed (canola)T.2A[Repealed, SOR/79-250, s. 25]
T.3thirambis (dimethylthiocarbamoyl) disulphide1Bananas (edible pulp)7Apples, celery, peaches/nectarines, strawberries, tomatoesT.4[Repealed, SOR/84-912, s. 3]
T.5tralkoxydim2-[1-(ethoxy-imino) propyl]-3-hydroxy-5-mesitylcyclohex-2-enone0.02Barley, wheatT.5.1triasulfuron1-[2-(2-chloroethoxy)-phenylsulphonyl]- 3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl) urea0.02WheatT.6triazolyl alanine plant metabolite from triazole fungicidestriazol-1-yl alanine (TA)2.0All food cropsT.7tribenuron-methylmethyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)methylamino]carbonyl] amino]sulfonyl]benzoate0.05Barley, oats, wheat0.02Flax, rapeseed (canola)0.01MilkT.7.1triclopyr3,5,6-trichloro-2-pyridyloxyacetic acid including the metabolite 3,5,6-trichloro-2-pyridinol0.5Liver and kidney of cattle, goats, hogs, horses and sheepT.7.2triflumizole1-[1-[[4-chloro-2-(trifluoromethyl) phenyl]imino]-2-propoxyethyl]-1H-imidazole, including metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, expressed as triflumizole2.5Grapes1.5Sour cherries, sweet cherries0.5Apples, pearsT.8trifluralinα,α,α-trifluoro- 2,6-dinitro-N,N- dipropyl-p-toluidine0.5CarrotsT.8.1triflusulfuron-methylmethyl 2-[4-dimethylamino-6-(2,2,2-trifluoroethoxy)-1,3,5-triazin-2-ylcarbamoylsulfamoyl]-m-toluate0.05Molasses, sugar, sugar beetsT.9trimethylsulfonium cationtrimethylsulfonium cation15Barley, oat milling fractions, excluding flour13Soybeans10Oats, rapeseed (canola)3Flax, peas, wheat1.5Lentils1Beans; kidney of cattle, goats, hogs, horses and sheep0.5Liver of cattle, goats, hogs and sheep; meat and meat by-products of cattle, goats, hogs, horses and sheep; milk0.1Kidney and liver of poultry0.05Meat of poultry0.02EggsT.10triticonazole5-[(4-chlorophenyl) methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol0.05Eggs, meat and meat by-products of cattle, goats, hogs, horses, poultry and sheep0.01Barley, milk, oats, wheatV[Repealed, SOR/79-665, s. 20]
V.1vinclozolin3-(3,5- dichlorophenyl)- 5-methyl-5-vinyl- 1,3-oxazolidine- 2,4-dione including metabolites containing the 3,5-dichloroaniline moiety expressed as vinclozolin10.0Kiwi fruit, strawberries5.0Apricots, grapes, lettuce3.0Cherries, tomatoes2.0Peaches/nectarines, peppers1.0Beans, cucumbers, plumsZ.2ziramzinc dimethyldithiocarbamate7Apples, apricots, beans, beets, blackberries, black-eyed peas, blueberries, (huckleberries), broccoli, Brussels sprouts, cabbage, carrots, cauliflower, celery, cherries, collards, cranberries, cucumbers, eggplants, gooseberries, grapes, kale, kohlrabi, lettuce, loganberries, melons, onions, peaches/nectarines, peanuts, pears, peas, peppers, pumpkins, quinces, radishes, raspberries, rutabagas, spinach, squash, strawberries, summer squash, tomatoes, turnips(Calculated as zineb)Z.3zoxamide3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide15Raisins3Grapes3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide, including the metabolites 3,5-dichloro-1,4-benzene-dicarboxylic acid and 3,5-dichloro-4-hydroxymethyl benzoic acid0.3Potato processed fractions (chips, flakes and granules)0.06PotatoesTABLE III
VETERINARY DRUGS
Column IColumn IIColumn IIIColumn IVItem No.Common Name (or Brand Name) of DrugName of Substance for Drug Analysis PurposesMaximum Residue Limit p.p.m.FoodsA.01albendazolealbendazole-2-aminosulfone0.2Liver of cattleA.1ampicillinampicillin0.01Edible tissue of swine and cattle; milkA.2amproliumamprolium0.5Muscle of chickens and turkeys1.0Liver and kidney of chickens and turkeys7.0EggsA.3apramycinapramycin0.1Kidney of swineA.4arsanilic acidarsenic0.5Muscle of swine, chickens and turkeys; eggs2.0Liver of swine, chickens and turkeysB.1buquinolatebuquinolate0.1Muscle of chickens0.4Liver, kidney, skin and fat of chickensC.01ceftiofurdesfuroyl-ceftiofur (DFC)0.1Milk1.0Muscle of cattle, sheep and swine2.0Liver and fat of cattle, sheep and swine5.0Kidney of swine6.0Kidney of cattle and sheepC.1cephapirincephapirin0.02Milk0.1Edible tissue of cattleC.2chlortetracyclinechlortetracycline0.1Kidney, liver and muscle of cattle; muscle of sheep0.2Fat of swine0.5Liver of sheep1.0Muscle, liver, skin and fat of chickens and turkeys; muscle of swine; muscle and fat of calves; kidney of sheep2.0Liver of swine4.0Kidney of swine, chickens and turkeys; liver and kidney of calvesC.3clopidolclopidol5.0Muscle of chickens and turkeys15.0Liver and kidney of chickens and turkeysD.1decoquinatedecoquinate1.0Muscle of cattle, goats and chickens2.0Kidney, liver and fat of cattle and goats; kidney, liver, skin and fat of chickensD.2dihydrostreptomycindihydrostreptomycin0.125MilkD.3dinitolmide (zoalene)dinitolmide, including the metabolite 3-amino-5-nitro-o-toluamide2.0Fat of chickens3.0Muscle of chickens and turkeys; liver and fat of turkeys6.0Liver and kidney of chickensE.1erythromycinerythromycin0.05Milk0.1Edible tissue of swine0.125Edible tissue of chickens and turkeysF.1fenbendazolefenbendazole0.45Liver of cattle4.5Liver of swineF.2florfenicolflorfenicol amine0.8Muscle of salmonids2Liver of cattleG.1gentamicingentamicin0.1Edible tissue of turkeys0.4Kidney of swineH.01halofuginonehalofuginone0.1Liver of chickenH.1hydrocortisonehydrocortisone0.01MilkI.1ivermectin22,23-dihydro-avermectin B1a0.015Liver of swine0.03Liver of sheep0.07Liver of cattleL.01lasalocidlasalocid0.35Fat and skin of chicken0.65Liver of cattleL.1levamisole hydrochloridelevamisole0.1Edible tissue of cattle, sheep and swine(calculated as levamisol hydro-chloride)M.01maduramicinmaduramicin0.4Fat and skin of chickenM.1monensinmonensin0.05Edible tissue of cattle, chickens and turkeysM.2morantel tartrateN-methyl-1,3-propane diamine0.1Milk0.5Liver of cattleM.3moxidectinmoxidectin0.55Fat of cattleN.01narasinnarasin0.5Fat of chickenN.1neomycinneomycin0.25Edible tissue of calvesN.2nicarbazinN,N1-bis(4-nitrophenyl)urea4.0Muscle, liver, kidney and skin of chickensN.3nitarsonearsenic0.5Muscle of turkeys2.0Liver of turkeysN.4novobiocinnovobiocin1.0Edible tissue of cattle, chickens and turkeysP.1penicillin Gpenicillin G0.01 I.U./mlMilk0.01Edible tissue of turkeys0.05Edible tissue of cattle and swineP.1.1pirlimycinpirlimycin0.3Muscle of cattle0.4Milk0.5Liver of cattleP.2polymyxin Bpolymyxin B4.0 u/mlMilkP.3pyrantel tartrateN-methyl-1,3-propane-diamine1.0Muscle of swine(calculated as pyrantel tartrate)10.0Liver and kidney of swine(calculated as pyrantel tartrate)R.1robenidine hydro-chloriderobenidine0.1Muscle, liver and kidney of chickens(calculated as robenidine hydro-chloride)0.2Skin and fat of chickens(calculated as robenidine hydro-chloride)R.2roxarsonearsenic0.5Muscle of swine, chickens and turkeys; eggs2.0Liver of swine, chickens and turkeysS.01salinomycinsalinomycin0.35Fat and skin of chicken; Liver of cattle and swineS.1spectinomycinspectinomycin0.1Edible tissue of chickensS.2streptomycinstreptomycin0.125MilkS.3sulfachlorpyridazinesulfachlorpyridazine0.1Edible tissue of cattle and swineS.3.1sulfadiazinesulfadiazine0.1Muscle of salmonidsS.4sulfadimethoxinesulfadimethoxine0.01Milk0.1Edible tissue of cattleS.5sulfaethoxypyridazinesulfaethoxypyridazine0.1Edible tissue of cattleS.6sulfamethazinesulfamethazine0.01Milk0.1Edible tissue of calves, cattle, chickens, swine and turkeysS.7sulfathiazolesulfathiazole0.1Edible tissue of swineT.01teflubenzuronteflubenzuron0.3Muscle of salmonids3.2Skin of salmonidsT.1tetracyclinetetracycline0.25Edible tissue of calves, swine, sheep, chickens and turkeysT.2thiabendazolethiabendazole and total 5-hydroxythiabendazole metabolites (free form, glucuronide and sulfate conjugates)0.05Milk0.1Edible tissue of cattle, goats and sheepT.3tiamulin8-alpha-hydroxy-mutilin0.4Liver of swineT.3.1tilmicosintilmicosin1.6Liver of cattleT.3.2trimethoprimtrimethoprim0.1Muscle of salmonidsT.4tylosintylosin0.2Muscle, liver, kidney and fat of cattle, swine, chickens and turkeysDIVISION 16
Food Additives
B.16.001 A quantitative statement of the amount of each additive present or directions for use that, if followed, will produce a food that will not contain such additives in excess of the maximum levels of use prescribed by these Regulations shall be shown, grouped together with the list of ingredients, of any substance or mixture of substances for use as a food additive.
B.16.002 A request that a food additive be added to or a change made in the Tables following section B.16.100 shall be accompanied by a submission to the Minister in a form, manner and content satisfactory to him and shall include
(a) a description of the food additive, including its chemical name and the name under which it is proposed to be sold, its method of manufacture, its chemical and physical properties, its composition and its specifications and, where that information is not available, a detailed explanation;
(b) a statement of the amount of the food additive proposed for use, and the purpose for which it is proposed, together with all directions, recommendations and suggestions for use;
(c) where necessary, in the opinion of the Director, an acceptable method of analysis suitable for regulatory purposes that will determine the amount of the food additive and of any substance resulting from the use of the food additive in the finished food;
(d) data establishing that the food additive will have the intended physical or other technical effect;
(e) detailed reports of tests made to establish the safety of the food additive under the conditions of use recommended;
(f) data to indicate the residues that may remain in or upon the finished food when the food additive is used in accordance with good manufacturing practice;
(g) a proposed maximum limit for residues of the food additive in or upon the finished food;
(h) specimens of the labelling proposed for the food additive; and
(i) a sample of the food additive in the form in which it is proposed to be used in foods, a sample of the active ingredient, and, on request a sample of food containing the food additive.
B.16.003 The Minister shall, within 90 days after the filing of a submission in accordance with section B.16.002, notify the person filing the submission whether or not it is his intention to recommend to the Governor-in-Council that the said food additive be so listed and the detail of any listing to be recommended.
B.16.004 [Repealed, SOR/97-148, s. 6]
B.16.006 Paragraph B.01.042(c) and paragraph B.01.043(a) do not apply to spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives.
B.16.007 No person shall sell a food containing a food additive other than a food additive provided for in sections B.01.042, B.01.043 and B.25.062.
B.16.008 [Repealed, SOR/88-418, s. 5]
B.16.100 No person shall sell any substance as a food additive unless the food additive is listed in one or more of the following Tables:
TABLE I
FOOD ADDITIVES THAT MAY BE USED AS ANTICAKING AGENTS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use C.1Calcium Aluminum(1)Salt(1)1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)Silicate(2)Garlic salt; Onion salt(2)2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively(3)Unstandardized dry mixes(3)Good Manufacturing PracticeC.2Calcium Phosphate(1)Salt(1)1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)tribasic(2)Garlic salt; Onion salt(2)2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively(3)Dry cure(3)Good Manufacturing Practice(4)Unstandardized dry mixes(4)Good Manufacturing Practice(5)Oil soluble annatto(5)Good Manufacturing Practice(6)Icing sugar(6)If used either singly or in combination with Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Magnesium Stearate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%C.3Calcium Silicate(1)Salt(1)1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)(2)Garlic salt; Onion salt(2)2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively(3)Baking Powder(3)5.0%(4)Dry cure(4)Good Manufacturing Practice(5)Unstandardized dry mixes(5)Good Manufacturing Practice(6)Icing sugar(6)If used either singly or in combination with Calcium Phosphate tribasic, Magnesium Carbonate, Magnesium Silicate, Magnesium Stearate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%(7)Meat Binder or (naming the meat product) Binder(7)1.0%(8)Grated or shredded (named variety) cheese; Grated or shredded cheddar cheese; Unstandardized grated or shredded cheese preparations(8)If used singly or in combination with microcrystalline cellulose or cellulose, the total amount not to exceed 2.0%(9)Dried whole egg; Dried egg white (dried albumen); Dried egg yolk; Dried whole egg mix; Dried egg yolk mix(9)2.0%C.4Calcium Stearate(1)Salt(1)1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)(2)Garlic salt; Onion salt(2)2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively(3)Unstandardized dry mixes(3)Good Manufacturing PracticeC.5CelluloseGrated or shredded (named variety) cheese; Grated or shredded cheddar cheese; Unstandardized grated or shredded cheese preparationsIf used singly or in combination with calcium silicate or microcrystalline cellulose, the total amount not to exceed 2.0%M.1Magnesium Carbonate(1)Salt (except when used in preparations of Meat and Meat By-products of Division 14)(1)1.0%, except in the case, of fine grained salt 2.0%, in accordance with the requirements of paragraph B.17.001(1)(a)(2)Garlic salt, Onion salt (except when used in preparations of Meat and Meat By-products of Division 14)(2)2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively(3)Unstandardized Dry Mixes (Except when used in preparations of Meat and Meat by-products of Division 14)(3)Good Manufacturing Practice(4)Icing sugar(4)If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Silicate, Magnesium Stearate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%M.2Magnesium OxideUnstandardized dry mixes (Except when used in preparations of Meat and Meat by-products of Division 14)Good Manufacturing PracticeM.3Magnesium Silicate(1)Salt(1)1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)(2)Garlic salt; Onion salt(2)2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively(3)Unstandardized dry mixes(3)Good Manufacturing Practice(4)Icing sugar(4)If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%M.4Magnesium Stearate(1)Salt(1)1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)(2)Garlic salt; Onion salt(2)2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively(3)Unstandardized dry mixes(3)Good Manufacturing Practice(4)Icing sugar(4)If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Silicon Dioxide or Sodium Aluminum Silicate the total must not exceed 1.5%M.5Microcrystalline CelluloseGrated or shredded (named variety) cheese; Grated or shredded cheddar cheese; Unstandardized grated or shredded cheese preparationsIf used singly or in combination with calcium silicate or cellulose, the total amount not to exceed 2.0%P.1Propylene GlycolSalt0.035%S.1Silicon Dioxide(1)Garlic salt; Onion salt(1)1.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively(2)Celery Salt; Celery Pepper(2)0.5%(3)Unstandardized dry mixes(3)Good Manufacturing Practice(4)Icing sugar(4)If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Magnesium Stearate or Sodium Aluminum Silicate the total must not exceed 1.5%(5)Foods sold in tablet form(5)Good Manufacturing Practice(6)Cayenne Pepper; Chili pepper; Chili Powder; Paprika; Red Pepper(6)2.0%(7)Salt(7)1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)S.2Sodium Aluminum(1)Salt(1)1.0%, except in the case of fine grained salt 2.0%, in accordance with the requirement of paragraph B.17.001(1)(a)Silicate(2)Icing sugar(2)If used either singly or in combination with Calcium Phosphate tribasic, Calcium Silicate, Magnesium Carbonate, Magnesium Silicate, Magnesium Stearate or Silicon Dioxide the total must not exceed 1.5%(3)Dried whole egg; Dried egg white (dried albumen); Dried egg yolk; Dried whole egg mix; Dried egg yolk mix(3)2.0%(4)Garlic salt; Onion salt(4)2.0% in accordance with the requirement of paragraphs B.07.020(b) and B.07.027(b) respectively(5)Unstandardized dry mixes(5)Good Manufacturing PracticeS.3Sodium Ferro- cyanide, decahydrateSalt13 p.p.m. calculated as anhydrous sodium ferrocyanideTABLE II
FOOD ADDITIVES THAT MAY BE USED AS BLEACHING, MATURING AND DOUGH CONDITIONING AGENTS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use A.1Acetone Peroxide(1)Bread; Flour; Whole wheat flour(1)Good Manufacturing Practice(2)Unstandardized bakery foods(2)Good Manufacturing PracticeA.1A[Repealed, SOR/79-660, s. 3]
A.2Ammonium(1)Flour; Whole wheat flour(1)250 p.p.m.Persulphate(2)Bread(2)100 p.p.m. of flour(3)Unstandardized bakery foods(3)Good Manufacturing PracticeA.2AAscorbic Acid(1)Bread; Flour; Whole wheat flour(1)200 p.p.m. of flour(2)Unstandardized bakery foods(2)200 p.p.m. of flourA.3[Repealed, SOR/79-660, s. 4]
A.3A[Repealed, SOR/79-660, s. 4]
A.4AzodicarbonamideBread; Flour; Whole wheat flour45 p.p.m. of flourB.1Benzoyl PeroxideFlour; Whole wheat flour150 p.p.m.C.1Calcium Iodate(1)Bread(1)45 p.p.m. of flour(2)Unstandardized bakery foods(2)45 p.p.m. of flourC.2Calcium Peroxide(1)Bread(1)100 p.p.m. of flour(2)Unstandardized bakery foods(2)Good Manufacturing PracticeC.3Calcium Stearoyl-2-(1)Bread(1)3,750 p.p.m. of flourLactylate(2)Unstandardized bakery foods(2)3,750 p.p.m. of flour(3)Cake mixes(3)0.5% of dry weight of mixC.4ChlorineFlour; Whole wheat flourGood Manufacturing PracticeC.5Chlorine DioxideFlour; Whole wheat flourGood Manufacturing PracticeC.6L-Cysteine Hydrochloride(1)Bread; Flour; Whole wheat flour(1)90 p.p.m.(2)Unstandardized bakery foods(2)Good Manufacturing PracticeP.1[Repealed, SOR/94-227, s. 4]
P.2Potassium Iodate(1)Bread(1)45 p.p.m. of flour(2)Unstandardized bakery foods(2)45 p.p.m. of flourP.3Potassium Persulphate(1)Bread(1)100 p.p.m. of flour(2)Unstandardized bakery foods(2)Good Manufacturing PracticeS.1Sodium(1)Bread(1)3,750 p.p.m. of flourStearoyl-2-(2)Unstandardized bakery foods(2)3,750 p.p.m. of flourLactylate(3)Pancakes and pancake mixes(3)0.3% of dry ingredient weight(4)Waffles and waffle mixes(4)0.3% of dry ingredient weight(5)Cake mixes(5)0.5% of dry weight of mixS.2Sodium(1)Bread(1)5,000 p.p.m. of flourStearyl Fumarate(2)Unstandardized bakery foods(2)5,000 p.p.m. of flourS.3Sodium SulphiteBiscuit dough500 p.p.m. calculated as Sulphur DioxideTABLE III
FOOD ADDITIVES THAT MAY BE USED AS COLOURING AGENTS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use 1Aluminum Metal
Alkanet
Annatto
Anthocyanins
Beet Red
Canthaxanthin
Carbon Black
Carotene
Charcoal
Chlorophyll
Cochineal
Iron Oxide
Orchil
Paprika
Riboflavin
Saffron
Saunderswood
Silver Metal
Titanium Dioxide
Turmeric
Xanthophyll
(1)Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated fruit juice except frozen concentrated orange juice; Fig marmalade with pectin: Ice cream mix; Ice milk mix; Icing sugar; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Liqueurs and alcoholic cordials; (naming the flavour) milk; Pickles and relishes; Pineapple marmalade with pectin; Sherbet; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Tomato catsup; Marinated or similar cold-processed packaged fish and meat (Division 21)(1)Good Manufacturing Practice(2)Liquid, dried or frozen whole egg; Liquid, dried or frozen egg yolk(2)Good Manufacturing Practice in accordance with paragraphs B.22.034(b) and B.22.035(b)(3)Unstandardized foods(3)Good Manufacturing Practice(4)Vegetable fats and oils(4)Good Manufacturing Practice in accordance with section B.09.001(5)Margarine(5)Good Manufacturing Practice(6)(named variety) Cheese; Cheddar cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(6)Good Manufacturing Practice in accordance with the requirements of sections B.08.033, B.08.034, B.08.037, B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 and B.08.041.8.(7)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(7)Good Manufacturing Practice(8)Longaniza; Tocino(8)0.1% in accordance with the requirements of paragraph B.14.031(i) or subparagraph B.14.032(d)(xvi)(9)Edible collagen film (iron oxide only)(9)Good Manufacturing Practice(10)Sausage casings (annatto only)(10)1.0% (Residues of annatto in sausage prepared with such casings not to exceed 100 p.p.m.)(11)Sausage casings (cochineal only)(11)0.75% (Residues of cochineal in sausage prepared with such casings not to exceed 75 p.p.m.)1Aß-apo- 8′-carotenal Ethyl ß-apo- 8′-carotenoate(1)Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated fruit juice except frozen concentrated orange juice; Fig marmalade with pectin; Ice cream mix; Ice milk mix; Icing sugar; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Liqueurs and alcoholic cordials; Margarine; (naming the flavour) milk; Pickles and relishes; Pineapple marmalade with pectin; Sherbet; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Tomato catsup(1)35 p.p.m.(2)Unstandardized foods(2)35 p.p.m.(3)(named variety) Cheese; Cheddar cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(3)35 p.p.m., in accordance with the requirements of sections B.08.033, B.08.034, B.08.037, B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 and B.08.041.8(4)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(4)35 p.p.m.2Caramel(1)Ale; Apple (or rhubarb) and (naming the fruit) jam; Beer; Brandy; Bread; Brown bread; Butter; Cider; Cider vinegar; Concentrated fruit juice except frozen concentrated orange juice; Fig marmalade with pectin; Holland’s gin; Ice cream mix; Ice milk mix; Icing sugar; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Light beer; Liqueurs and alcoholic cordials; Malt liquor; Malt vinegar; (naming the flavour) milk; Mincemeat; Pickles and relishes; Pineapple marmalade with pectin; Porter; Rum; Sherbet; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Stout; Tomato catsup; Whisky; Wine; Wine vinegar; Honey wine(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing Practice(3)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(3)Good Manufacturing Practice(4)Sausage casings(4)15% (Residues of caramel in sausage prepared with such casings not to exceed 0.15%)3Allura Red Amaranth
Erythrosine Indigotine
Sunset Yellow FCF
Tartrazine
(1)Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated fruit juice except frozen concentrated orange juice; Fig marmalade with pectin; Ice cream mix; Ice milk mix; Icing sugar; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Liqueurs and alcoholic cordials; (naming the flavour) milk; Pickles and relishes; Pineapple marmalade with pectin; Sherbet; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Tomato catsup(1)300 p.p.m. singly or in combination in accordance with section B.06.002(2)Unstandardized foods(2)300 p.p.m. singly or in combination in accordance with section B.06.002(3)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(3)300 p.p.m. singly or in combination in accordance with section B.26.002(4)Salted anchovy, salted scad and salted shrimp(4)125 p.p.m. in accordance with the requirements of paragraph B.21.021(d)(5)Longaniza(5)80 p.p.m. allura red in accordance with the requirements of clause B.14.032(d)(xvi)(B) and 20 p.p.m. sunset yellow FCF in accordance with the requirements of clause B.14.032(d)(xvi)(C)(6)Sausage casings (sunset yellow FCF only)(6)0.15% (Residues of sunset yellow FCF in sausage prepared with such casings not to exceed 15 p.p.m.)4Brilliant Blue FCF
Fast Green FCF
(1)Apple (or rhubarb) and (naming the fruit) jam; Bread; Butter; Concentrated fruit juice except frozen concentrated orange juice; Fig marmalade with pectin; Ice cream mix; Ice milk mix; Icing sugar; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Liqueurs and alcoholic cordials; (naming the flavour) milk; Pickles and relishes; Pineapple marmalade with pectin; Sherbet; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids; Smoked fish; Lobster paste and fish roe (caviar); Tomato catsup(1)100 p.p.m. singly or in combination in accordance with section B.06.002(2)Unstandardized foods(2)100 p.p.m. singly or in combination in accordance with section B.06.002(3)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(3)100 p.p.m. singly or in combination in accordance with section B.06.002(4)Feta cheese (brilliant blue FCF only)(4)0.10 p.p.m.5Citrus Red No. 2Skins of whole oranges2 p.p.m.6Ponceau SXFruit Peel; Glacé fruits; Maraschino Cherries150 p.p.m.7GoldAlcoholic beveragesGood Manufacturing PracticeTABLE IV
FOOD ADDITIVES THAT MAY BE USED AS EMULSIFYING, GELLING, STABILIZING AND THICKENING AGENTS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use A.1Acacia Gum(1)Cream; French dressing; (naming the flavour) Milk; Mustard pickles; (naming the flavour) Partly skimmed milk; (naming the flavour) Partly skimmed milk with added milk solids; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Skim milk with added milk solids;(1)Good Manufacturing Practice(2)Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Sherbet(3)0.75%(4)Unstandardized foods(4)Good Manufacturing Practice(5)Calorie-reduced margarine(5)0.5% in accordance with the requirements of section B.09.017(6)Canned asparagus; Canned green beans; Canned wax beans; Canned peas(6)1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)A.2Acetylated Mono- glyceridesUnstandardized foodsGood Manufacturing PracticeA.3Acetylated Tartaric(1)Bread(1)6,000 p.p.m. of flourAcid Esters of Mono- and Di-glycerides(2)Unstandardized foods(2)Good Manufacturing Practice(3)Infant formulas based on crystalline amino acids(3)240 p.p.m. as consumedA.4Agar(1)Brawn; Canned (naming the poultry); Cream; Headcheese; (naming the fruit) Jelly with pectin; Meat binder (when sold for use in prepared meat or meat by-products in which a gelling agent is a permitted ingredient); Meat by-product loaf; Meat loaf; (naming the flavour) Milk; Mustard pickles; Potted meat; Potted meat by-product; Prepared fish or prepared meat (Division 21); Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids(1)Good Manufacturing Practice(2)Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Sherbet(3)0.75%(4)Unstandardized foods(4)Good Manufacturing Practice(5)Calorie-reduced margarine(5)0.5% in accordance with the requirements of section B.09.017A.5Algin(1)Ale; Beer; Cream; French dressing; Light beer; Malt liquor; (naming the flavour) Milk; Mustard pickles; Porter; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Stout(1)Good Manufacturing Practice(2)Infant formula(2)0.03% as consumed. If used in combination with carrageenan or guar gum or both, the total not to exceed 0.03%(3)Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix(3)0.5%(4)Sherbet(4)0.75%(5)Unstandardized foods(5)Good Manufacturing Practice(6)Calorie-reduced margarine(6)0.5% in accordance with the requirements of section B.09.017(7)Sour cream(7)0.5% in accordance with the requirements of clause B.08.077(b)(vii)(A)(8)Canned asparagus; Canned green beans; Canned wax beans; Canned peas(8)1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)(9)Infant formula based on isolated amino acids or protein hydrolysates, or both(9)0.1% as consumed. If used in combination with carrageenan or guar gum or both, the total not to exceed 0.1%(10)Lactose-free infant formula based on milk protein(10)0.05% as consumed. If used in combination with carrageenan or guar gum or both, the total not to exceed 0.05%A.6Alginic AcidSame foods as listed for AlginSame levels as prescribed for AlginA.7Ammonium AlginateSame foods as listed for AlginSame levels as prescribed for AlginA.8Ammonium CarrageenanSame foods as listed for CarrageenanSame levels as prescribed for CarrageenanA.9Ammonium FurcelleranSame foods as listed for FurcelleranSame levels as prescribed for FurcelleranA.9AAmmonium Salt of Phosphorylated Glyceride(1)Bread; Cream; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids(1)Good Manufacturing Practice(2)Ice Cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Sherbet(3)0.75%(4)Unstandardized foods(4)Good Manufacturing Practice(5)Chocolate products; Cocoa products(5)0.7%A.10Arabino-galactan(1)Essential oils; unstandardized dressings, pudding mixes; beverage bases and mixes; pie filling mixes(1)Good Manufacturing PracticeB.1Baker’s yeast
Glycan
Unstandardized foodsGood Manufacturing PracticeC.1Calcium AlginateSame foods as listed for AlginSame levels as prescribed for AlginC.2Calcium Carbonate(1)Unstandardized Foods(1)Good Manufacturing Practice(2)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(2)Good Manufacturing PracticeC.3Calcium CarrageenanSame foods as listed for CarrageenanSame levels as prescribed for CarrageenanC.4Calcium Citrate(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)4.0%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4(2)Unstandardized foods(2)Good Manufacturing PracticeC.5Calcium FurcelleranSame foods as listed for FurcelleranSame levels as prescribed for FurcelleranC.6Calcium GluconateUnstandardized foodsGood Manufacturing PracticeC.7Calcium GlycerophosphateUnstandardized dessert mixesGood Manufacturing PracticeC.8Calcium HypophosphiteUnstandardized dessert mixesGood Manufacturing PracticeC.9Calcium Phosphate, dibasic(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4(2)Unstandardized foods(2)Good Manufacturing PracticeC.10Calcium Phosphate, tribasicUnstandardized foodsGood Manufacturing PracticeC.11Calcium Sulphate(1)Ice cream; Ice cream mix; Ice milk; Ice milk mix(1)0.5%(2)Sherbet(2)0.75%(3)Unstandardized foods(3)Good Manufacturing Practice(4)Creamed cottage cheese(4)0.05%(5)Cream for whipping, heat-treated above 100°C(5)0.005%C.12Calcium TartrateUnstandardized foodsGood Manufacturing PracticeC.13Carboxymethyl CelluloseSame foods as listed for Sodium Carboxymethyl CelluloseSame levels as prescribed for Sodium Carboxymethyl CelluloseC.14Carob Bean Gum(1)Cream; French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids(1)Good Manufacturing Practice(2)Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Calorie-reduced margarine(3)0.5% in accordance with the requirements of paragraph B.09.017(b)(4)Sherbet(4)0.75%(5)Sour cream(5)0.5% in accordance with the requirements of clause B.08.077(b)(vii)(A)(6)Unstandardized Foods(6)Good Manufacturing Practice(7)Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(7)0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8C.15Carrageenan(1)Ale; Beer; Brawn; Canned (naming the poultry); Cream; French dressing; Headcheese; (naming the fruit) Jelly with pectin; Light beer; Malt liquor; Meat binder (when sold for use in prepared meat or prepared meat by-products in which a gelling agent is a permitted ingredient); Meat by-product loaf; Meat loaf; (naming the flavour) Milk; Mustard pickles; Porter; Potted meat; Potted meat by-product; Prepared fish or prepared meat (Division 21); Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Stout(1)Good Manufacturing Practice(2)Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Evaporated milk(3)0.015%(4)Sherbet(4)0.75%(5)Evaporated partly skimmed milk; Concentrated partly skimmed milk(5)0.01%(6)Infant formula based on isolated amino acids or protein hydrolysates, or both(6)0.1% as consumed. If used in combination with algin or guar gum or both, the total not to exceed 0.1%(7)Infant formula(7)0.03% as consumed. If used in combination with algin or guar gum or both, the total not to exceed 0.03%(8)Unstandardized foods(8)Good Manufacturing Practice(9)Calorie-reduced margarine(9)0.5% in accordance with the requirements of section B.09.017(10)Sour cream(10)0.5%, in accordance with the requirements of clause B.08.077(b)(vii)(A)(11)Canned asparagus; Canned green beans; Canned wax beans; Canned peas(11)1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)(12)Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(12)0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8(13)Lactose-free infant formula based on milk protein(13)0.05% as consumed. If used in combination with algin or guar gum or both, the total not to exceed 0.05%C.17Cellulose GumSame foods as listed for Sodium Carboxymethyl CelluloseSame levels as prescribed for Sodium Carboxymethyl CelluloseF.1Furcelleran(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing Practice(3)Calorie-reduced margarine(3)0.5% in accordance with the requirements of section B.09.017(4)Canned asparagus; Canned green beans; Canned waxed beans; Canned peas(4)1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)G.1Gelatin(1)Brawn; Canned (naming the poultry); Cream; Headcheese; (naming the fruit) Jelly with pectin; Meat binder (when sold for use in prepared meat by-products in which a gelling agent is a permitted ingredient); Meat by-product loaf; Meat loaf; (naming the flavour) Milk; Mustard pickles; Potted meat; Potted meat by-product; Prepared fish or prepared meat (Division 21); Prepared hams, shoulders, butts and picnics; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids(1)Good Manufacturing Practice(2)Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Sherbet(3)0.75%(4)Sour cream(4)0.5% in accordance with the requirements of clause B.08.077(b)(vii)(A)(5)Unstandardized Foods(5)Good Manufacturing Practice(6)Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(6)0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8G.2Gellan Gum(1)Confectionery; Frostings; (except for any of these products for which standards are set out in these Regulations)(1)0.5%(2)Fruit spreads; Aspic; Processed fruit products; (except for any of these products for which standards are set out in these Regulations)(2)0.3%(3)Calorie-reduced margarine; Reduced fat spreads(3)0.25%(4)Dairy products (except for any of these products for which standards are set out in these Regulations)(4)0.15%(5)French Dressing; Salad Dressing; Dressings (except for any of these products for which standards are set out in these Regulations); Gelatins; Puddings; Fillings(5)0.1%(6)Baking mixes; Bakery products; (except for any of these products for which standards are set out in these Regulations)(6)0.1% of the dry mix(7)Sauces; Toppings; Table syrups; (except for any of these products for which standards are set out in these Regulations)(7)0.05%(8)Beverages (except for any of these products for which standards are set out in these Regulations)(8)0.08%(9)Snack foods (except for any of these products for which standards are set out in these Regulations)(9)0.1%G.3Guar Gum(1)Cream; French dressing; (naming the flavour) Milk; Mince meat; Mustard pickles; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids;(1)Good Manufacturing Practice(2)Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Infant formula(3)0.03% as consumed. If used in combination with algin or carrageenan or both, the total not to exceed 0.03%(4)Sherbet(4)0.75%(5)Unstandardized foods(5)Good Manufacturing Practice(6)Calorie-reduced margarine(6)0.5% in accordance with the requirements of section B.09.017(7)Sour cream(7)0.5% in accordance with the requirements of clause B.08.077(b)(vii)(A)(8)Canned asparagus; Canned green beans; Canned waxed beans; Canned peas(8)1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)(9)Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(9)0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8(10)Infant formula based on isolated amino acids or protein hydrolysates, or both(10)0.1% as consumed. If used in combination with algin or carrageenan or both, the total not to exceed 0.1%(11)Lactose-free infant formula based on milk protein(11)0.05% as consumed. If used in combination with algin or carrageenan or both, the total not to exceed 0.05%G.4Gum ArabicSame foods as listed for Acacia GumSame level as prescribed for Acacia GumH.1Hydroxylated Lecithin(1)Chocolate products; Cocoa products(1)1.0%(2)Unstandardized foods(2)Good Manufacturing PracticeH.1AHydroxypropyl CelluloseUnstandardized foodsGood Manufacturing PracticeH.2Hydroxypropyl Methylcellulose(1)French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Salad dressing(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeI.1Irish Moss GeloseSame foods as listed for CarrageenanSame levels as prescribed for CarrageenanK.1Karaya Gum(1)French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids; Salad dressing(1)Good Manufacturing Practice(2)Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Sherbet(3)0.75%(4)Unstandardized foods(4)Good Manufacturing Practice(5)Calorie-reduced margarine(5)0.5% in accordance with the requirements of section B.09.017L.1Lactylated Mono- and Di-glycerides(1)Shortening(1)8.0% (except that the total combined mono- and di-glycerides and lactylated mono- and di-glycerides must not exceed 20.0% of the shortening)(2)Unstandardized foods(2)8.0% of the fat contentL.1ALactylic Esters of Fatty AcidsUnstandardized foodsGood Manufacturing PracticeL.2Lecithin(1)Bread; Cream; (naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids(1)Good Manufacturing Practice(2)Ice Cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%, singly or in combination with other emulsifiers(3)Infant formula(3)0.03% as consumed(4)Sherbet(4)0.75%(5)Unstandardized foods(5)Good Manufacturing Practice(6)Margarine(6)0.2%(7)Calorie-reduced margarine(7)0.5%(8)Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(8)0.2%(9)Milk powder(9)0.5%(10)Chocolate products; Cocoa products(10)1.0%L.3Locust Bean GumSame foods as listed for Carob Bean GumSame levels as prescribed for Carob Bean GumM.1Magnesium ChlorideTofu0.3%, calculated as the anhydrous saltM.2Methylcellulose(1)Ale; Beer; French dressing; Light beer; Malt liquor; Porter; Salad dressing; Stout(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeM.3Methyl Ethyl CelluloseUnstandardized foodsGood Manufacturing PracticeM.4Mono-glycerides(1)Bread; Cream; Fish paste(1)Good Manufacturing Practice(2)Chocolate products; Cocoa products(2)1.5%(3)Ice cream mix; Ice milk mix(3)A total of 0.5% of stabilizing agents in accordance with subparagraphs B.08.061(b)(vi) and B.08.071(b)(vi)(4)Creamed cottage cheese(4)Good Manufacturing Practice(5)Infant formula(5)0.25% as consumed(6)Sausage casings(6)0.35% of the casing(7)Margarine(7)0.5%(8)Sherbet(8)0.75%(9)Shortening(9)10.0% (except that the total combined mono and diglycerides and lactylated mono and diglycerides must not exceed 20.0% of the shortening)(10)Sour Cream(10)0.3%(11)Unstandardized Foods(11)Good Manufacturing Practice(12)Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(12)0.5% in accordance with the requirements of sections B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4M.5Mono- and (1)Bread; Cream; Fish paste(1)Good Manufacturing PracticeDi-glycerides(2)Chocolate products; Cocoa products(2)1.5%(3)Ice cream mix; Ice milk mix(3)A total of 0.5% of stabilizing agents in accordance with subparagraphs B.08.061(b)(vi) and B.08.071(b)(vi)(4)Cottage Cheese; Creamed Cottage Cheese(4)Good Manufacturing Practice(5)Infant formula(5)0.25% as consumed(6)Sausage casings(6)0.35% of the casing(7)Margarine(7)0.5%(8)Sherbet(8)0.75%(9)Shortening(9)10.0% (except that the total combined mono and diglycerides and lactylated mono and diglycerides must not exceed 20.0% of the shortening)(10)Sour Cream(10)0.3%(11)Unstandardized Foods(11)Good Manufacturing Practice(12)Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(12)0.5% in accordance with the requirements of sections B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4M.6Monosodium Salts of Phosphorylated Mono- and Diglycerides(1)Edible vegetable oil-based cookware coating emulsions(1)4.0%O.1Oat Gum(1)Unstandardized Foods(1)Good Manufacturing PracticeP.1Pectin(1)Apple (or rhubarb) and (naming the fruit) Jam; Cream; Fig marmalade; Fig marmalade with pectin; French dressing; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade with pectin; (naming the flavour) Milk; Mince meat; Mustard pickles; Pineapple marmalade; Pineapple marmalade with pectin; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids(1)Good Manufacturing Practice(2)Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Sour cream(3)0.5% in accordance with the requirement of clause B.08.077(b)(vii)(A)(4)Sherbet(4)0.75%(5)Unstandardized foods(5)Good Manufacturing PracticeP.1APolyglycerol Esters of Fatty Acids(1)Unstandardized foods(1)Good Manufacturing Practice(2)Vegetable oils(2)0.025%(3)Calorie-reduced margarine(3)0.2% in accordance with the requirements of paragraph B.09.017(c)P.1BPolyglycerol Esters of Interesterified(1)Chocolate products(1)0.5%Castor Oil Fatty Acids(2)Unstandardized chocolate flavoured confectionery coatings(2)0.25%(3)Edible vegetable oil-based pan coating emulsions for use on baking pans(3)2.0%P.2Polyoxyethylene (20)
Sorbitan Monooleate;
Polysorbate 80
(1)Ice cream; Ice cream mix; Ice milk; Ice milk mix; Sherbet(1)0.1%. If Polyoxyethylene (20) sorbitan tristearate is also used, the total must not exceed 0.1%(2)Unstandardized frozen desserts(2)0.1%(3)Pickles and relishes(3)0.05%(4)Beverage base or mix(4)0.05% of the beverage. If sorbitan monostearate is also used the total must not exceed 0.05% of the beverage(5)Imitation dry cream mix(5)0.1%. If Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.4%(6)Whipped vegetable oil topping(6)0.05%. If Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.4%(7)Cake icing; cake icing mix(7)0.5% of the finished cake icing. If Polyoxyethylene (20) sorbitan monostearate, or Sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.5% of the finished cake icing(8)Salt(8)10 p.p.m.(9)Whipped cream(9)0.1%(10)Breath freshener products in candy, tablet or gum form(10)100 p.p.m.(11)Creamed cottage cheese(11)80 p.p.m.(12)Spice oils and spice oleoresins for use in pumping pickle employed in the curing of preserved meat or preserved meat by-product (Division 14)(12)0.2% of the pumping pickle(13)Sausage casings(13)0.15% of the casing(14)Liquid Smoke Flavours(14)Good Manufacturing Practice. Residues of Polysorbate 80 must not exceed 275 ppm in the finished food(15)Vegetable oils(15)0.125%(16)Annatto formulations(16)25% of the total colour formulation(17)Turmeric formulations(17)50% of the total colour formulation(18)Liquid smoke flavour concentrate(18)Good Manufacturing Practice. Residues of Polysorbate 80 must not exceed 0.3% in the finished food.(19)Unstandardized salad dressing(19)0.25%P.3Polyoxyethylene (20)
Sorbitan Monostearate;
Polysorbate 60
(1)Imitation dry cream mix; Vegetable oil creaming agent; Whipped vegetable oil topping; Vegetable oil topping mix(1)0.4%. If Polyoxyethylene (20) sorbitan tristearate, Sorbitan monostearate or Polyoxyethylene (20) sorbitan mono-oleate, either singly or in combination is also used, the total must not exceed 0.4%, except that in the case of whipped vegetable oil topping a combination of Polysorbate 60 and Sorbitan monostearate may be used in excess of 0.4%, if the amount of the Polysorbate 60 does not exceed 0.77% and the amount of Sorbitan monostearate does not exceed 0.27% of the whipped vegetable oil topping(2)Cakes(2)0.5% on a dry weight basis. If Polyoxyethylene (20) sorbitan tristearate is also used, the total must not exceed 0.5% on a dry weight basis(3)Cakes; Cake mixes(3)0.5% on a dry weight basis. If Sorbitan monostearate is also used, the total must not exceed 0.7% on a dry weight basis(4)Unstandardized confectionery coatings and unstandardized moulded confectionery products for use as confectionery or in baking(4)0.5%. If any combination of Polyoxyethylene (20) Sorbitan tristearate, Sorbitan monostearate or Sorbitan tristearate are all used the total must not exceed 1.0%(5)Cake icing; Cake icing mix(5)0.5% of the finished cake icing. If Sorbitan monostearate or Polyoxyethylene (20) sorbitan mono-oleate either singly or in combination is also used, the total must not exceed 0.5% of the finished cake icing(6)Pudding; Pie filling(6)0.5% on a dry weight basis(7)Beverage base or mix(7)0.05% of the beverage. If Sorbitan monostearate is also used the total must not exceed 0.05% of the beverage(8)Sour Cream Substitute(8)0.1%(9)Unstandardized dressings; Unstandardized prepared canned cooking sauces(9)0.3%(10)Fat base formulation for self-basting of poultry by injection(10)0.25%(11)Unstandardized sandwich spreads and dips(11)0.2%(12)Dry soup base or mix(12)250 p.p.m. in soup as prepared for consumption(13)Dry batter coating mixes(13)0.5% of the dry mix(14)Prepared alcoholic cocktails(14)120 p.p.m. in beverage as prepared for consumptionP.4Polyoxyethylene (20)
Sorbitan Tristearate;
Polysorbate 65
(1)(Naming the flavour) Milk; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids(1)0.5%(2)Ice cream; Ice cream mix; Ice milk; Ice milk mix; Sherbet(2)0.1%. If Polyoxyethylene (20) sorbitan mono-oleate is also used, the total must not exceed 0.1%(3)Unstandardized frozen desserts(3)0.1%(4)Cakes(4)0.3% on a dry weight basis. If Polyoxyethylene (20) sorbitan monostearate is also used, the total must not exceed 0.5% on a dry weight basis(5)Unstandardized confectionery coatings(5)0.5%. If any combination of Polyoxyethylene (20) sorbitan monostearate, Sorbitan monostearate, or Sorbitan tristearate are also used, the total must not exceed 1.0%(6)Beverage base or mix(6)0.05% of the beverage. If Sorbitan monostearate is also used, the total must not exceed 0.05% of the beverage(7)Imitation dry cream mix; Vegetable oil creaming agent; Whipped vegetable oil topping; Vegetable oil topping mix(7)0.4%. If Polyoxyethylene (20) sorbitan monostearate, Sorbitan monostearate or Polyoxyethylene (20) sorbitan mono-oleate, either singly or in combination is also used, the total must not exceed 0.4%(8)Breath freshener products in candy, tablet or gum form(8)200 p.p.m.P.5Polyoxyethylene (8) StearateUnstandardized bakery foods0.4%P.6Potassium AlginateSame foods as listed for AlginSame levels as prescribed for AlginP.7Potassium CarrageenanSame foods as listed for CarrageenanSame levels as prescribed for CarrageenanP.8Potassium ChlorideUnstandardized foodsGood Manufacturing PracticeP.9Potassium Citrate(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)4.0%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4P.10Potassium FurcelleranSame foods as listed for FurcelleranSame levels as prescribed for FurcelleranP.11Potassium Phosphate, dibasic(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4P.12Propylene Glycol Alginate(1)Ale; Beer; French dressing; Light beer; Malt liquor; Mustard pickles; Porter; Relishes; Salad dressing; Stout(1)Good Manufacturing Practice(2)Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Sherbet(3)0.75%(4)Unstandardized foods(4)Good Manufacturing Practice(5)Calorie-reduced margarine(5)0.5% in accordance with the requirements of section B.09.017(6)Sour cream(6)0.5% in accordance with the requirements of clause B.08.077(b)(vii)(A)(7)Canned asparagus; Canned green beans; Canned wax beans; Canned peas(7)1.0% in accordance with the requirements of clause B.11.002(d)(viii)(C)(8)Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(8)0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8P.13Propylene Glycol Ether of MethylcelluloseSame foods as listed for Hydroxypropyl MethylcelluloseSame levels as prescribed for Hydroxypropyl MethylcelluloseP.14Propylene Glycol
Mono Fatty Acid Esters
Unstandardized foodsGood Manufacturing PracticeS.1Sodium Acid Pyrophosphate(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4S.2Sodium Alginate(1)Same foods as listed for Algin(1)Same levels as prescribed for Algin(2)Coarse crystal salt(2)15 p.p.m.(3)Glaze of frozen fish(3)Good Manufacturing PracticeS.2ASodium Alumi- num Phosphate(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4S.3Sodium Carboxymethyl Cellulose(1)Cream; French dressing; (naming the flavour) Milk; Mustard pickles; Relishes; Salad dressing; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids(1)Good Manufacturing Practice(2)Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Sherbet(3)0.75%(4)Unstandardized foods(4)Good Manufacturing Practice(5)Glaze of frozen fish(5)Good Manufacturing Practice(6)Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients)(6)0.5%(7)Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(7)0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8S.4Sodium CarrageenanSame foods as listed for CarrageenanSame levels as prescribed for CarrageenanS.5Sodium Cellulose GlycolateSame foods as listed for Sodium Carboxymethyl CelluloseSame levels as prescribed for Sodium Carboxymethyl CelluloseS.6Sodium Citrate(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)4.0%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4(2)Evaporated milk; evaporated skim milk or concentrated skim milk; evaporated partly skimmed milk or concentrated partly skimmed milk(2)0.1% singly or in combination with sodium phosphate, dibasic(3)Ice cream; Ice cream mix; Ice milk; Ice milk mix(3)0.5%(4)Sherbet(4)0.75%S.7Sodium FurcelleranSame foods as listed for FurcelleranSame levels as prescribed for FurcelleranS.8Sodium Gluconate(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)4.0%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4S.9Sodium Hexameta- phosphate(1)Mustard pickles; Relishes(1)Good Manufacturing Practice(2)Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Infant formula(3)0.05% as consumed(4)Sherbet(4)0.75%(5)Unstandardized foods(5)Good Manufacturing Practice(6)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(6)3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4(7)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(7)0.1%S.11Sodium Phosphate, dibasic(1)(Naming the flavour) Milk; Mustard pickles; Relishes; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; (naming the flavour) Skim Milk with added milk solids; (naming the flavour) Partly skimmed milk with added milk solids(1)Good Manufacturing Practice(2)Cottage cheese; Creamed cottage cheese(2)0.5%(3)Evaporated milk; evaporated skim milk or concentrated skim milk; evaporated partly skimmed milk or concentrated partly skimmed milk(3)0.1% singly or in combination with sodium citrate(4)Sour cream(4)0.05% in accordance with the requirements of clause B.08.077(b)(vii)(C)(5)Unstandardized Foods(5)Good Manufacturing Practice(6)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(6)3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4S.12Sodium Phosphate, monobasic(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4(2)Unstandardized foods(2)Good Manufacturing PracticeS.13Sodium Phosphate, tribasic(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4(2)Unstandardized foods(2)Good Manufacturing PracticeS.14Sodium Potassium Tartrate(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)4.0%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4(2)Unstandardized foods(2)Good Manufacturing PracticeS.15Sodium Pyrophosphate, tetrabasic(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)3.5%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4(2)Unstandardized foods(2)Good Manufacturing Practice(3)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(3)0.1%S.15ASodium Stearoyl-2-Lac-tylate(1)Icing and icing mixes(1)0.4% of dry ingredient weight(2)Fillings and filling mixes(2)0.5% of dry ingredient weight(3)Puddings and pudding mixes(3)0.2% of the finished product(4)Sour cream substitutes(4)1.0% of dry ingredient weight(5)Vegetable oil creaming agents(5)2.0% of dry ingredient weight(6)Batter mix(6)0.75% of dry ingredient weight(7)Unstandardized cream-based liquors(7)0.35% of the finished product(8)Salad dressing; French dressing(8)0.4% of the finished product(9)Soups(9)0.2% of the finished productS.16Sodium Tartrate(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(1)4.0%, in accordance with the requirements of sections B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3 and B.08.041.4S.16ASodium TripolyphosphateA blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)0.1%S.18Sorbitan Monostearate(1)Imitation dry cream mix; Vegetable oil creaming agent; Whipped vegetable oil topping; Vegetable oil topping mix(1)0.4%. If Polyoxyethylene (20) sorbitan tristearate, Polysorbate 60 or Polyoxyethylene (20) sorbitan mono-oleate, either singly or in combination is also used, the total must not exceed 0.4%, except that in the case of whipped vegetable oil topping a combination of Sorbitan monostearate and Polysorbate 60 may be used in excess of 0.4% if the amount of Sorbitan monostearate does not exceed 0.27% and the amount of Polysorbate 60 does not exceed 0.77% of the weight of the whipped vegetable oil topping(2)Cake; Cake mix(2)0.6% on a dry weight basis. If Polyoxyethylene (20) sorbitan monostearate is also used, the total must not exceed 0.7% on a dry weight basis(3)Unstandardized confectionery coatings and unstandardized moulded confectionery products for use as confectionery or in baking(3)1.0%. If any combination of Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristrearate or Sorbitan tristearate are also used, the total must not exceed 1.0%(4)Cake icing; Cake icing mix(4)0.5% of the finished cake icing. If Polyoxyethylene (20) sorbitan mono-oleate or Polyoxyethylene (20) sorbitan monostearate, either singly or in combination is also used, the total must not exceed 0.5% of the finished cake icing(5)Beverage base or mix(5)0.05% of the beverage. If Polyoxyethylene (20) sorbitan mono-oleate is also used, the total must not exceed 0.05% of the beverage. If Polyoxyethylene (20) sorbitan monostearate is also used, the total must not exceed 0.05% of the beverage. If Polyoxyethylene (20) sorbitan tristearate is also used, the total must not exceed 0.05% of the beverage(6)Dry soup base or mix(6)250 p.p.m. in soup as prepared for consumption(7)Dried yeast(7)1.5% (Residues of sorbitan monostearate in bread and other yeast leavened bakery products not to exceed 0.05%).(8)Chocolate products(8)1.0%S.18ASorbitan trioleateSausage casings0.35% of the casingS.18BSorbitan Tristearate(1)Margarine; Shortening(1)1.0%(2)Unstandardized confectionery coatings and unstandardized moulded confectionery products for use as a confectionery or in baking(2)1.0% If any combination of Polyoxyethylene (20) sorbitan monostearate, Polyoxyethylene (20) sorbitan tristearate or Sorbitan monostearate are also used, the total must not exceed 1.0%S.19Stearyl Monoglyceridyl CitrateShorteningGood Manufacturing PracticeS.20Sucrose esters of fatty acidsCarotenoid colour preparations1.5%T.2[Repealed, SOR/2006-91, s. 5]
T.3Tragacanth Gum(1)French dressing; Mustard pickles; Salad dressing; Relishes(1)Good Manufacturing Practice(2)Cottage cheese; Creamed cottage cheese; Ice cream; Ice cream mix; Ice milk; Ice milk mix(2)0.5%(3)Sherbet(3)0.75%(4)Lumpfish Caviar(4)1.0%(5)Unstandardized foods(5)Good Manufacturing Practice(6)Calorie-reduced margarine(6)0.5% in accordance with the requirements of section B.09.017(7)Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients)(7)0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8X.1Xanthan Gum(1)French Dressing; Salad Dressing; Unstandardized Foods(1)Good Manufacturing Practice(2)Cottage Cheese; Creamed Cottage Cheese(2)0.5% or, if used in combination with other stabilizing agents, the total amount of the combined stabilizers shall not exceed 0.5%(3)Calorie-reduced margarine(3)0.5% in accordance with the requirements of section B.09.017(4)Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(4)0.5%, in accordance with the requirements of sections B.08.035, B.08.037, B.08.038, B.08.039, B.08.041.3, B.08.041.4, B.08.041.6, B.08.041.7 and B.08.041.8(5)Mustard pickles; relishes(5)0.1%(6)Ice Cream Mix(6)0.1% or, if used in combination with microcrystalline cellulose and other stabilizers, the total amount of combined stabilizers and microcrystalline cellulose shall not exceed 0.5%(7)Ice Milk Mix(7)0.1% or, if used in combination with other stabilizers, the total amount of combined stabilizers shall not exceed 0.5%(8)Sherbet(8)0.1% or, if used in combination with other stabilizers, the total amount of combined stabilizers shall not exceed 0.75%(9)Cream for whipping, heat-treated above 100°C(9)0.02%TABLE V
FOOD ADDITIVES THAT MAY BE USED AS FOOD ENZYMES
Column IColumn IIColumn IIIColumn IVItemPermittedPermittedMaximumNoAdditiveSourcein or UponLevel of Use A.01α-Acetolactate decarboxylaseBacillus subtilis
ToC46(pUW235)
(1)Brewers’ Mash(1)Good Manufacturing Practice(2)Distillers’ Mash(2)Good Manufacturing PracticeA.02AminopeptidaseLactococcus lactis
(1)Cheese(1)Good Manufacturing Practice(2)Dairy based flavouring preparations(2)Good Manufacturing Practice(3)Hydrolyzed animal, milk and vegetable protein(3)Good Manufacturing PracticeA.1AmylaseAspergillus niger
var.;Aspergillus oryzae
var.;Bacillus subtilis
var.;Rhizopus oryzae
var.; Barley Malt(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Bread; Flour; Whole wheat flour(2)Good Manufacturing Practice(3)Cider; Wine(3)Good Manufacturing Practice(4)Chocolate syrups(4)Good Manufacturing Practice(5)Distillers’ Mash(5)Good Manufacturing Practice(6)Malt-flavoured dry breakfast cereals(6)Good Manufacturing Practice(7)Single-strength fruit juices(7)Good Manufacturing Practice(8)Precooked (instant) cereals(8)Good Manufacturing Practice(9)Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup)(9)Good Manufacturing Practice(10)Unstandardized bakery products(10)Good Manufacturing PracticeAspergillus niger
STz18-9 (pHUda7)(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Distillers’ Mash(2)Good Manufacturing Practice(3)Starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), maltose(3)Good Manufacturing PracticeBacillus amyloliquefaciens
EBA 20 (pUBH2);Bacillus licheniformis
;Bacillus licheniformis
BML 592 (pAmyAmp);Bacillus licheniformis
BML 730 (pAmyAmp);Bacillus licheniformis
LA 57 (pDN1981);Bacillus licheniformis
LAT8 (pLAT3);Bacillus licheniformis
LiH 1159 (pLiH1108);Bacillus licheniformis
LiH 1464 (pLiH1346);Bacillus licheniformis
PL 1303 (pPL1117)(1)Distillers’ Mash(1)Good Manufacturing Practice(2)Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup)(2)Good Manufacturing Practice(3)Brewers’ mash(3)Good Manufacturing PracticeBacillus stearothermophilus
(1)Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup)(2)Distillers’ Mash(2)Good Manufacturing Practice(3)Brewers’ Mash(3)Good Manufacturing Practice(4)Bread; Flour; Whole wheat flour(4)Good Manufacturing Practice(5)Unstandardized bakery products(5)Good Manufacturing PracticeBacillus subtilis
B1.109 (pCPC720) (ATCC 39, 705)(1)Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup)(1)Good Manufacturing PracticeBacillus subtilis
B1.109 (pCPC800)(1)Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup)(1)Good Manufacturing Practice(2)Distillers’ Mash(2)Good Manufacturing Practice(3)Brewers’ Mash(3)Good Manufacturing Practice(4)Bakery Products(4)Good Manufacturing PracticeA.2Amylase (maltogenic)Bacillus subtilis
DN1413 (pDN1413);Bacillus subtilis
LFA 63 (pLFA63)(1)Starch used in the production of dextrins, maltose, dextrose, glucose, (glucose syrup) or glucose solids (dried glucose syrup)(1)Good manufacturing practice(2)Bread; Flour; Whole wheat flour(2)Good manufacturing practice(3)Unstandardized bakery products(3)Good manufacturing practiceB.1Bovine RennetAqueous extracts from the fourth stomach of adult bovine animals, sheep and goatsCheese, cottage cheese, cream cheese, cream cheese with (named added ingredients), cream cheese spread, cream cheese spread with (named added ingredients)Good Manufacturing PracticeB.2BromelainThe pineapplesAnanas comosus
andAnanas bracteatus
(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Bread; Flour; Whole wheat flour(2)Good Manufacturing Practice(3)Sausage casings(3)Good Manufacturing Practice(4)Hydrolyzed animal, milk and vegetable protein(4)Good Manufacturing Practice(5)Meat cuts(5)Good Manufacturing Practice(6)Meat tenderizing preparations(6)Good Manufacturing Practice(7)Pumping pickle for the curing of beef cuts(7)Good Manufacturing Practice in accordance with paragraph B.14.009(g)(8)Sugar wafers, waffles, pancakes(8)Good Manufacturing PracticeC.1CatalaseAspergillus niger
var.;Micrococcus lysodeikticus
; Bovine (Bos taurus
) liver(1)Soft drinks(1)Good Manufacturing Practice(2)Egg albumen(2)Good Manufacturing Practice(3)Liquid whey treated with hydrogen peroxide in accordance with item H.1, Table VIII(3)Good Manufacturing PracticeC.2CellulaseAspergillus niger
var.(1)Distillers’ Mash(1)Good Manufacturing Practice(2)Liquid coffee concentrate(2)Good Manufacturing Practice(3)Spice extracts; Natural flavour and colour extractives(3)Good Manufacturing PracticeTrichoderma reesei
QM 9414(1)Single-strength fruit juices(1)Good Manufacturing Practice(2)Tea leaves for the production of tea solids(2)Good Manufacturing PracticeC.3Chymosin(i) Chymosin A
Escherichia coli
K-12, GE81 (pPFZ87A)(1)Cheddar cheese; (naming the variety) cheese; Cottage cheese; Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Sour cream(1)Good Manufacturing Practice(2)Unstandardized milk-based dessert preparations(2)Good Manufacturing Practice(ii) Chymosin B
Aspergillus niger
var.awamori
, GCC0349 (pGAMpR);Kluyvero-myces marxianus
var.lactis
, DS1182 (pKS105)(1)Cheddar cheese; (naming the variety) cheese; Cottage cheese; Cream cheese; Cream cheese with (naming the added ingredients); Cream cheese spread; Cream cheese spread with (naming the added ingredients); Sour cream(1)Good Manufacturing Practice(2)Unstandardized milk-based dessert preparations(2)Good Manufacturing PracticeF.1FicinLatex of fig tree (Ficus
sp.)(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Sausage casings(2)Good Manufacturing Practice(3)Hydrolyzed animal, milk and vegetable protein(3)Good Manufacturing Practice(4)Meat cuts(4)Good Manufacturing Practice(5)Meat tenderizing preparations(5)Good Manufacturing Practice(6)Pumping pickle for the curing of beef cuts(6)Good Manufacturing Practice in accordance with paragraph B.14.009(g)G.1Glucoamylase (Amyloglucosidase; Maltase)Aspergillus niger
var.;Aspergillus oryzae
var.;Rhizopus oryzae
var.(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Bread; Flour; Whole wheat flour(2)Good Manufacturing Practice(3)Chocolate syrups(3)Good Manufacturing Practice(4)Distillers’ Mash(4)Good Manufacturing Practice(5)Precooked (instant) cereals(5)Good Manufacturing Practice(6)Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup), or glucose solids (dried glucose syrup)(6)Good Manufacturing Practice(7)Unstandardized bakery products(7)Good Manufacturing PracticeAspergillus niger
STz18-9 (pHUda7)(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Distillers’ Mash(2)Good Manufacturing Practice(3)Starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), maltose(3)Good Manufacturing PracticeRhizopus niveus
var.(1)Distillers’ Mash(1)Good Manufacturing Practice(2)Mash destined for vinegar manufacture(2)Good Manufacturing PracticeRhizopus delemar
var.;Multiplici sporus
(1)Brewers’ Mash(1)Good Manufacturing Practice(2)Distillers’ Mash(2)Good Manufacturing Practice(3)Mash destined for vinegar manufacture(3)Good Manufacturing Practice(4)Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup), or glucose solids (dried glucose syrup)(4)Good Manufacturing PracticeG.2GlucanaseAspergillus niger
var.;Bacillus subtilis
var.(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Corn for degermination(2)Good Manufacturing Practice(3)Distillers’ Mash(3)Good Manufacturing Practice(4)Mash destined for vinegar manufacture(4)Good Manufacturing Practice(5)Unstandardized bakery products(5)Good Manufacturing PracticeHumicola insolens
var.(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Distillers’ Mash(2)Good Manufacturing PracticeG.3Glucose oxidaseAspergillus niger
var.(1)Soft drinks(1)Good Manufacturing Practice(2)Liquid whole egg; Egg white (albumen); and Liquid egg yolk destined for drying(2)Good Manufacturing Practice in accordance with paragraphs B.22.034(b), B.22.035(b) and B.22.036(b)(3)Bread; flour; Whole wheat flour(3)Good manufacturing practice(4)Unstandardized bakery products(4)Good manufacturing practiceG.4Glucose IsomeraseBacillus coagulans
var.;Streptomyces olivochromogenes
var.;Actinoplanes missouriensis
var.;Streptomyces olivaceus
var.;Microbacterium arborescens
NRRL B-11022;Streptomyces murinus
DSM 3252;Streptomyces rubiginosus
ATCC No. 21,175;Streptomyces rubiginosus
SYC 5406 (pSYC5239)(1)Glucose (glucose syrup) to be partially or completely isomerized to fructose(1)Good Manufacturing PracticeH.1HemicellulaseBacillus subtilis
var.(1)Distillers’ Mash(1)Good Manufacturing Practice(2)Liquid coffee concentrate(2)Good Manufacturing Practice(3)Mash destined for vinegar manufacture(3)Good Manufacturing PracticeI.01InulinaseAspergillus niger var. Tieghem
InulinGood Manufacturing PracticeI.1InvertaseSaccharomyces
sp.(1)Soft-centred and liquid-centred confections(1)Good Manufacturing Practice(2)Unstandardized bakery foods(2)Good Manufacturing PracticeL.1LactaseAspergillus niger
var.;Aspergillus oryzae
var.;Kluyveromyces fragilis
(Kluyveromyces marxianus
var.marxianus
);Kluyveromyces lactis
(Kluyveromyces marxianus
var.lactis
);Saccharomyces
sp. (1)Lactose-reducing enzyme preparations(1)Good Manufacturing Practice(2)Milk destined for use in ice cream mix(2)Good Manufacturing Practice(3)Bread; Flour; whole wheat flour(3)Good Manufacturing Practice(4)(naming the flavour) milk; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) malted milk; (naming the flavour) skimmed milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids(4)Good Manufacturing PracticeCell-free extracts fromCandida pseudotropicalis
(1)Milk destined for use in ice cream mix(1)Good Manufacturing Practice(2)Yogurt(2)Good Manufacturing Practice(3)Whey(3)Good Manufacturing Practice(4)(naming the flavour) milk; (naming the flavour) skim milk; (naming the flavour) partly skimmed milk; (naming the flavour) malted milk; (naming the flavour) skim milk with added milk solids; (naming the flavour) partly skimmed milk with added milk solids(4)Good Manufacturing PracticeL.2LipaseAnimal pancreatic tissue;Aspergillus niger
var.;Aspergillus oryzae
var.; Edible forestomach tissue of calves, kids or lambs;Rhizopus oryzae
var.(1)Dairy based flavouring preparations (1)Good Manufacturing Practice(2)Liquid and dried egg white (liquid and dried albumen)(2)Good Manufacturing Practice(3)Asiago cheese; Blue cheese; Caciocavallo cheese; Cheddar cheese; Cheddar for processing (Cheddar cheese; stirred curd cheese; granular curd cheese; washed curd cheese); Feta cheese; Parmesan cheese; Provolone cheese; Romano cheese(3)Good Manufacturing Practice(4)Bread; Flour; Whole wheat flour(4)Good Manufacturing Practice(5)Unstandardized bakery products(5)Good Manufacturing Practice(6)Hydrolyzed animal, milk and vegetable protein(6)Good Manufacturing PracticeAspergillus oryzae
(MLT-2) (pRML 787) (p3SR2);Rhizomucor miehei
(Cooney and Emerson) (previous name:Mucor miehei
(Cooney and Emerson
));Rhizopus niveus
(1)Modified fats and oils(1)Good Manufacturing Practice(2)Cheese(2)Good Manufacturing Practice(3)Dairy based flavouring preparations(3)Good Manufacturing Practice(4)Hydrolyzed animal, milk and vegetable protein(4)Good Manufacturing PracticePenicillium camembertii
(1)Edible fats and oils(1)Good Manufacturing PracticeL.3LipoxidaseSoyabean whey or meal(1)Bread; Flour; Whole wheat flour(1)Good Manufacturing PracticeL.4LysozymeEgg whiteCheeseGood Manufacturing PracticeM.1Milk coagulating enzymeRhizomucor miehei
(Cooney and Emerson) (previous name:Mucor miehei
(Cooney and Emerson)) orMucor pusillus Lindt
by pure culture fermentation process orAspergillus oryzae
RET-1 (pBoel777)(1)Cheese; Cottage Cheese; Sour cream (1)Good Manufacturing Practice(2)Dairy based flavouring preparations(2)Good Manufacturing Practice(3)Hydrolyzed animal, milk and vegetable protein(3)Good Manufacturing PracticeEndothia parasitica
by pure culture fermentation processes(1)Emmentaler (Emmental, Swiss) Cheese(1)Good Manufacturing Practice(2)Parmesan Cheese(2)Good Manufacturing Practice(3)Romano Cheese(3)Good Manufacturing Practice(4)Mozzarella (Scamorza) Cheese(4)Good Manufacturing Practice(5)Part Skim Mozzarella (Part Skim Scamorza) Cheese(5)Good Manufacturing PracticeP.1PancreatinPancreas of the hog (Sus scrofa
) or ox (Bos taurus
)(1)Liquid and dried egg white (liquid and dried albumen)(1)Good Manufacturing Practice(2)Precooked (instant) cereals(2)Good Manufacturing Practice(3)Starch used in the production of dextrins, maltose, dextrose, glucose (glucose syrup), or glucose solids (dried glucose syrup)(3)Good Manufacturing Practice(4)Hydrolyzed animal, milk and vegetable proteins(4)Good Manufacturing PracticeP.2PapainFruit of the papayaCarica papaya
L. (Fam.Caricaceae
)(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Beef before slaughter(2)Good Manufacturing Practice(3)Sausage casings; Water-soluble edible collagen films(3)Good Manufacturing Practice(4)Hydrolyzed animal, milk and vegetable protein(4)Good Manufacturing Practice(5)Meat cuts(5)Good Manufacturing Practice(6)Meat tenderizing preparations(6)Good Manufacturing Practice(7)Precooked (instant) cereals(7)Good Manufacturing Practice(8)Pumping pickle for the curing of beef cuts(8)Good Manufacturing Practice(9)Unstandardized bakery products(9)Good Manufacturing PracticeP.3PectinaseAspergillus niger
var.;Rhizopus oryzae
var.(1)Cider; Wine(1)Good Manufacturing Practice(2)Distillers’ Mash(2)Good Manufacturing Practice(3)Single-strength fruit juices(3)Good Manufacturing Practice(4)Natural flavour and colour extractives(4)Good Manufacturing Practice(5)Skins of citrus fruits destined for jam, marmalade and candied fruit production(5)Good Manufacturing Practice(6)Vegetable stock for use in soups(6)Good Manufacturing Practice(7)Tea leaves for the production of tea solids(7)Good Manufacturing PracticeAspergillus oryzae
Km-1-1 (pA2PEI)(1)Cider; Wine(1)Good Manufacturing Practice(2)Single-strength fruit juices(2)Good Manufacturing Practice(3)Unstandardized fruit and vegetable products(3)Good Manufacturing PracticeP.4PentosanaseAspergillus niger
var.;Bacillus subtilis
var.(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Corn for degermination(2)Good Manufacturing Practice(3)Distillers’ Mash(3)Good Manufacturing Practice(4)Mash destined for vinegar manufacture(4)Good Manufacturing Practice(5)Unstandardized bakery products(5)Good Manufacturing Practice(6)Bread; Flour; Whole wheat flour(6)Good Manufacturing PracticeTrichoderma reesei
(QM9414)(1)Bread; Flour; Whole wheat flour(1)Good Manufacturing Practice(2)Distiller’s Mash(2)Good Manufacturing Practice(3)Unstandardized bakery products(3)Good Manufacturing PracticeP.5PepsinGlandular layer of porcine stomach(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Cheese; Cottage cheese; Cream cheese; Cream cheese with (added named ingredients); Cream cheese spread; Cream cheese spread with (added named ingredients)(2)Good Manufacturing Practice(3)Defatted soya flour(3)Good Manufacturing Practice(4)Precooked (instant) cereals(4)Good Manufacturing Practice(5)Hydrolyzed animal, milk and vegetable proteins(5)Good Manufacturing PracticeP.6ProteaseAspergillus oryzae
var.;Aspergillus
niger
var.;Bacillus subtilis
var.(1)Ale; Beer; Light beer; Malt liquor;Porter; Stout(1)Good Manufacturing Practice(2)Bread; Flour;(2)Good ManufacturingWhole wheat flourPractice(3)Dairy based flavouring(3)Good ManufacturingpreparationsPractice(4)Distillers’ Mash(4)Good Manufacturing Practice(5)Sausage casings(5)Good Manufacturing Practice(6)Hydrolyzed animal, milk and vegetable protein(6)Good Manufacturing Practice(7)Industrial spray-dried cheese powder(7)Good Manufacturing Practice(8)Meat cuts(8)Good Manufacturing Practice(9)Meat tenderizing preparations(9)Good Manufacturing Practice(10)Precooked (instant) cereals(10)Good Manufacturing Practice(11)Unstandardized bakery foods(11)Good Manufacturing Practice(12)Cheddar cheese; Cheddar cheese for processing (granular curd cheese; Stirred curd cheese; Washed curd cheese); Colby cheese(12)Good Manufacturing PracticeMicrococcus caseolyticus
var.(1)Hard or semihard, pressed and soft varietal cheeses(1)Good Manufacturing PracticeBacillus licheniformis
(Cx)(1)Hydrolyzed animal, milk and vegetable protein(1)Good Manufacturing PracticeP.7PullulanaseBacillus acidopullulyticus
NCIB 11647; Bacillus licheniformis SE2-Pul-int211 (pUBCDEBR A11DNSI)(1)Bread; Flour; Whole wheat flour(1)Good Manufacturing Practice(2)Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose(2)Good Manufacturing Practice(3)Unstandardized bakery products(3)Good Manufacturing PracticeBacillus licheniformis
BMP 139 (pR11Amp)(1)Bread; Flour; Whole wheat flour(1)Good Manufacturing Practice(2)Brewers’ Mash(2)Good Manufacturing Practice(3)Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose(3)Good Manufacturing Practice(4)Unstandardized bakery products(4)Good Manufacturing PracticeBacillus subtilis
B1-163 (pEB301)(1)Bread; Flour; Whole wheat flour(1)Good Manufacturing Practice(2)Brewers’ Mash(2)Good Manufacturing Practice(3)Distillers’ Mash(3)Good Manufacturing Practice(4)Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose(4)Good Manufacturing Practice(5)Unstandardized bakery products(5)Good Manufacturing PracticeR.1RennetAqueous extracts from fourth stomach of calves, kids, or lambs(1)Cheese; Cottage cheese; Cream cheese; Cream cheese with (added named ingredients); Cream cheese spread; Cream cheese spread with (added named ingredients); sour cream(1)Good Manufacturing Practice(2)Unstandardized milk based dessert preparations(2)Good Manufacturing PracticeT.01TransglutaminaseStreptoverticillium mobaraense
strain S-8112(1)Prepared fish products (except for any of these products for which standards are set out in these Regulations)(1)Good Manufacturing Practice(2)Simulated meat products(2)Good Manufacturing Practice(3)Cheese products (except for any of these products for which standards are set out in these Regulations)(3)Good Manufacturing Practice(4)Processed cheese products (except for any of these products for which standards are set out in these Regulations)(4)Good Manufacturing Practice(5)Cream cheese products (except for any of these products for which standards are set out in these Regulations)(5)Good Manufacturing Practice(6)Yogurt(6)Good Manufacturing Practice(7)Frozen dairy desserts (except for any of these products for which standards are set out in these Regulations)(7)Good Manufacturing PracticeT.1TrypsinPancreas of the hog (Sus scrofa
)(1)Hydrolyzed animal, milk and vegetable proteins(1)Good Manufacturing PracticeX.1XylanaseAspergillus oryzae
Fa 1-1 (pA2X1TI)Bread; Flour; Whole wheat flourGood Manufacturing PracticeTABLE VI
FOOD ADDITIVES THAT MAY BE USED AS FIRMING AGENTS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use A.1Aluminum Sulphate(1) Canned crabmeat, lobster, salmon, shrimp and tuna; Pickles and relishes
(1) Good Manufacturing Practice
(2) Unstandardized foods
(2) Good Manufacturing Practice
(1) Pickles and relishes
(1) Good Manufacturing Practice
(2) Unstandardized foods
(2) Good Manufacturing Practice
(1) Canned apples
(1) 0.026% calculated as calcium
(2) Canned grapefruit
(2) 0.035% calculated as calcium in accordance with subparagraph B.11.101(c)(vii)
(3) (named variety) cheese; Cheddar cheese
(3) 0.02% of the milk and milk products used
(4) Cottage cheese
(4) Good Manufacturing Practice
(5) Glaze of frozen fish
(5) Good Manufacturing Practice
(6) Olives
(6) 1.5% of the brine
(7) Pickles and relishes
(7) 0.4%
(8) Tomatoes; Canned vegetables (naming the vegetable); Frozen apples
(8) 0.026% calculated as calcium, and in the case of canned peas 0.035% calculated as calcium
(9) Unstandardized foods
(9) Good Manufacturing Practice
(1) Tomatoes; Canned vegetables; Frozen apples; Frozen sliced apples
(1) 0.026% calculated as calcium
(2) Canned apples
(2) 0.026% calculated as calcium
(3) Unstandardized foods
(3) Good Manufacturing Practice
Unstandardized foods
Good Manufacturing Practice
C.3ACalcium Lactate(1) Canned grapefruit
(1) 0.035% calculated as calcium in accordance with subparagraph B.11.101(c)(vii)
(2) Canned peas
(2) 0.035% calculated as calcium
Unstandardized foods
Good Manufacturing Practice
C.5Calcium Phosphate, monobasic(1) Tomatoes; Canned vegetables; Frozen apples
(1) 0.026% calculated as calcium
(2) Canned apples
(2) 0.026% calculated as calcium
(3) Unstandardized foods
(3) Good Manufacturing Practice
(1) Tomatoes; Canned vegetables; Frozen apples
(1) 0.026% calculated as calcium
(2) Canned apples
(2) 0.026% calculated as calcium
(1) Pickles and relishes
(1) Good Manufacturing Practice
(2) Unstandardized foods
(2) Good Manufacturing Practice
(1) Pickles and relishes
(1) Good Manufacturing Practice
(2) Unstandardized foods
(2) Good Manufacturing Practice
TABLE VII
FOOD ADDITIVES THAT MAY BE USED AS GLAZING AND POLISHING AGENTS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use A.1Acetylated Monoglyce-(1)Confectionery(1)0.4%rides(2)Frozen fish(2)Good Manufacturing PracticeB.1BeeswaxConfectionery0.4%C.1Carnauba WaxConfectionery0.4%C.2Candelilla WaxConfectionery0.4%G.1Gum ArabicConfectionery0.4%G.2Gum BenzoinConfectionery0.4%M.1Magnesium SilicateConfectionery0.4%M.2Mineral OilConfectionery0.15%P.1PetrolatumConfectionery0.15%S.1ShellacCake decorations; Confectionery0.4%S.2Spermaceti WaxConfectionery0.4%Z.1ZeinConfectionery1.0%TABLE VIII
MISCELLANEOUS FOOD ADDITIVES
Column IColumn IIColumn IIIColumn IVItem
No.
AdditivePermitted in or UponPurpose of UseMaximum Level of Use A.01Acacia GumAle; Beer; Light beer; Malt liquor; Porter; Stout; WineFining agentGood Manufacturing PracticeA.1Acetylated MonoglyceridesUnstandardized foodsCoating; Release agentGood Manufacturing PracticeA.1.01AgarWineFining agentGood Manufacturing PracticeA.1.1Aluminum SulphateLiquid or frozen whole egg; Egg white (albumen) or egg yolkTo stabilize albumen during pasteurization0.036%A.2Ammonium PersulphateBrewer’s yeastAntimicrobial agent0.1%A.3[Repealed, SOR/93-276, s. 4]
A.4[Repealed, SOR/93-276, s. 5]
B.2BeeswaxUnstandardized foodsAntisticking agent0.4%B.2.1Benzoyl PeroxideLiquid whey destined for the manufacture of dried whey products other than those for use in infant formulaTo decolourize100 p.p.m.B.3Brominated vegetable oil(Naming the flavour) Flavour for use in citrus-flavoured or spruce-flavoured beveragesDensity adjusting agent15 p.p.m. in citrus-flavoured or spruce-flavoured beverages as consumedB.4n-ButaneEdible vegetable oil-based or lecithin-based pan coatings or a mixture of bothPropellantGood Manufacturing PracticeC.1CaffeineCola type beveragesTo characterize the product200 p.p.m. in the finished productC.2Caffeine CitrateCola type beveragesTo characterize the product200 p.p.m. calculated as caffeine, in the finished productC.3Calcium Carbonate(1)Flour; Whole wheat flour(1)Carrier of benzoyl peroxide(1)900 p.p.m., in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi)(2)[Repealed, SOR/94-227, s. 5]
(3)Confectionery(3)Creaming and fixing agent(3)Good Manufacturing Practice(4)Chewing gum(4)Filler(4)Good Manufacturing Practice(5)Unstandardized foods(5)Carrier and dusting agent(5)Good Manufacturing PracticeC.3ACalcium Lactate(1)Egg albumen (delysozymized)(1)Restoration of functional properties(1)Good Manufacturing Practice (Quantity of calcium added not to exceed that lost during processing)(2)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(2)To modify texture(2)Good Manufacturing PracticeC.4Calcium Oxide(1)Frozen crustaceans and molluscs(1)To facilitate the removal of extraneous matter and to reduce moisture loss during cooking(1)When used in combination with sodium chloride (salt) and sodium hydroxide in solution, calcium oxide not to exceed 30 p.p.m.(2)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(2)To modify texture(2)Good Manufacturing PracticeC.5Calcium Phosphate dibasic(1)Flour; Whole wheat flour(1)Carrier of benzoyl peroxide(1)900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi)(2)[Repealed, SOR/94-227, s. 6]
C.6Calcium Phosphate, tribasic(1)Flour; Whole wheat flour(1)Carrier of benzoyl peroxide(1)900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi)(2)[Repealed, SOR/94-227, s. 7]
(3)Liquid whey destined for the manufacture of dried whey products other than those for use in infant formula(3)Carrier of benzoyl peroxide(3)0.04% of dried whey product(4)Processed (naming the variety) cheese; Processed (naming the variety) cheese with (naming the added ingredient); Processed cheese food; Processed cheese food with (naming the added ingredients); Processed cheese spread; Processed cheese spread with (naming the added ingredients)(4)To improve colour, texture, consistency and spreadability(4)1.0%C.7Calcium SilicateOil-soluble annattoCarrierGood Manufacturing PracticeC.8Calcium StearateConfectioneryRelease agentGood Manufacturing PracticeC.9Calcium Stearoyl-(1)Liquid and frozen egg whites(1)Whipping agent(1)0.05%2-Lactylate(2)Dried egg whites(2)Whipping agent(2)0.5%(3)Vegetable fat toppings(3)Whipping agent(3)0.3%(4)Dehydrated potatoes(4)Conditioning agent(4)0.2% of dry weightC.10Calcium Sulphate(1)Flour, Whole wheat flour(1)Carrier of benzoyl peroxide(1)900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi)(2)[Repealed, SOR/94-227, s. 8]
(3)Baking powder(3)Neutral filler(3)Good Manufacturing PracticeC.11Carbon Dioxide(1)Ale; Beer; Carbonated (naming the fruit) juice; Cider; Light beer; Malt liquor; Porter; Stout; Wines; Water represented as mineral water or spring water(1)Carbonation(1)Good Manufacturing Practice(2)Unstandardized foods(2)Carbonation and pressure dispensing agent(2)Good Manufacturing Practice(3)Cottage Cheese; Creamed Cottage Cheese(3)To extend durable life(3)Good Manufacturing PracticeC.12Castor OilConfectioneryRelease agentGood Manufacturing PracticeC.13Cellulose Microcrystalline(1)Ice milk mix(1)Bodying and texturizing agent(1)1.5%(2)Sherbet(2)Bodying and texturizing agent(2)0.5%(3)Carbohydrate or calorie reduced dietetic foods(3)Filler(3)Good Manufacturing Practice(4)Whipped vegetable oil topping(4)Bodying and texturizing agent(4)1.5%(5)Unstandardized frozen desserts(5)Bodying and texturizing agent(5)0.5%(6)Unstandardized sandwich spreads and dips(6)Bodying and texturizing agent(6)3.0%(7)Unstandardized foods other than those unstandardized foods in this item(7)Bodying and texturizing agent(7)2.0%(8)Ice cream mix(8)Bodying and texturizing agent(8)0.5% or, if used in combination with stabilizing agents, the combined amount shall not exceed 0.5% of the ice cream made from the mix(9)Table-top sweetener tablets containing aspartame(9)Tablet disintegration(9)2.2%(10)Cream for whipping, heat-treated above 100°C(10)Stabilizing and thickening agent(10)0.2%C.14AChloropentafluo-roethaneUnstandardized foodsPressure dispensing and aerating agentGood Manufacturing PracticeC.15Citric Acid(1)Beef blood(1)Anticoagulant(1)Good Manufacturing Practice(2)Unstandardized foods(2)Culture nutrient(2)Good Manufacturing PracticeC.16Copper gluconateBreath freshener products in candy, tablet or gum formTo characterize the product50 p.p.m.C.17Copper SulphateWineFining agent0.0001%, calculated as copper, in the finished productD.1Dimethylpolysiloxane Formulations(1)Apple (or rhubarb) and (naming the fruit) Jam; Fats and oils; Fig marmalade; Fig marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade; Pineapple marmalade with pectin; Reconstituted lemon juice; Reconstituted lime juice; Shortening; Skim milk powder; Wine(1)Antifoaming agent(1)10 p.p.m. of dimethylpolysiloxane(2)Pineapple juice; Blends of pineapple juice with other fruit juices; canned pineapple (when pineapple juice is used as the packing medium)(2)Anti-foaming agent(2)10 p.p.m. of dimethylpolysiloxane(3)Surfaces that come in contact with food(3)Release agent(3)Good Manufacturing Practice (Residue of dimethylpolysiloxane in food not to exceed 10 p.p.m.)(4)Unstandardized foods(4)Antifoaming agent(4)10 p.p.m. of dimethylpolysiloxane(5)Wort used in the manufacture of Ale, Beer, Light beer, Malt liquor, Porter and Stout(5)Antifoaming agent(5)10 p.p.m. of dimethylpolysiloxaneD.3Dioctyl sodium sulfosuccinate(1)Fumaric acid-acidulated dry beverage bases(1)Wetting agent(1)10 p.p.m. in the finished drink(2)Sausage casings(2)Reduce casing breakage(2)200 p.p.m. of the casingE.1EthoxyquinPaprika; Ground chili pepperTo promote colour retention100 p.p.m.E.2Ethylene OxideWhole or ground spice (except mixtures containing salt)FumigationG.M.P. (Residues of ethylene chlorohydrin not to exceed 1,500 p.p.m.)F.1Ferrous GluconateRipe olivesColour retentionGood Manufacturing PracticeG.1GelatinBeer; Cider; WineFining agentGood Manufacturing PracticeG.2[Repealed, SOR/89-175, s. 2]
G.2AGlucono delta lactone(1)Cooked sausage, Meat Loaf(1)To accelerate colour fixing(1)0.5%(2)Dry Sausage(2)To assist in curing(2)Good Manufacturing PracticeG.3Glycerol(1)Meat curing compounds; Sausage casings(1)Humectant(1)Good Manufacturing Practice(2)Preserved meats (Division 14)(2)Glaze for preserved meats(2)Good Manufacturing Practice(3)Unstandardized foods(3)Humectant; Plasticizer(3)Good Manufacturing PracticeG.4Glycerol ester of wood rosinCitrus-flavoured or spruce-flavoured beveragesDensity adjusting agent100 p.p.m.H.1Hydrogen Peroxide(1)Brewers’ mash(1)Clarification aid(1)135 p.p.m. in the mash(2)Liquid whey destined for the manufacture of dried whey products(2)To decolourize and maintain pH(2)100 p.p.m. (see also subitem C.1(3) of Table V)IIsobutaneEdible vegetable oil-based or lecithin-based pan coatings or a mixture of bothPropellantGood Manufacturing PracticeL.1Lactylic Esters of Fatty AcidsUnstandardized foodsPlasticizing agentGood Manufacturing PracticeL.2LanolinChewing gumPlasticizing agentGood Manufacturing PracticeL.3LecithinSurfaces that come in contact with foodRelease agentGood Manufacturing PracticeL.4L-LeucineTable-top sweetener tablets containing aspartameLubricant in tablet manufacture3% of tablet weightM.1Magnesium Aluminum SilicateChewing gumDusting agentGood Manufacturing PracticeM.2Magnesium Carbonate(1)Flour, Whole wheat flour(1)Carrier of benzoyl peroxide(1)900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi)(2)[Repealed, SOR/94-227, s. 9]
(3)Confectionery(3)Release agent(3)Good Manufacturing PracticeM.2AMagnesium ChlorideEgg albumen (delysozymized)Restoration of functional propertiesGood Manufacturing Practice (Quantity of magnesium added not to exceed that lost during processing)M.3Magnesium Silicate(1)Confectionery(1)Release agent(1)Good Manufacturing Practice(2)Chewing gum(2)Dusting agent(2)Good Manufacturing Practice(3)Rice(3)Coating(3)Good Manufacturing PracticeM.4Magnesium(1)Confectionery(1)Release agent(1)Good Manufacturing PracticeStearate(2)Foods sold in tablet form(2)Binding agent(2)Good Manufacturing PracticeM.4AMagnesium SulphateEgg albumen (delysozymized)Restoration of functional propertiesGood Manufacturing Practice (Quantity of magnesium added not to exceed that lost during processing)M.5A[Repealed, SOR/93-276, s. 6]
M.5CMethyl Ethyl CelluloseUnstandardized foodsAerating agentGood Manufacturing PracticeM.6Microcrystalline CelluloseSame foods as listed for Cellulose, MicrocrystallineFillerSame levels as prescribed for Cellulose, MicrocrystallineM.7Mineral Oil(1)Bakery products; Confectionery; Seeded raisins(1)Release agent(1)0.3% in accordance with section B.01.047. If petrolatum is also used as a release agent in bakery products the total of any combination of petrolatum and mineral oil must not exceed 0.15%(2)Fresh fruits and vegetables(2)Coating(2)0.3% in accordance with section B.01.047(3)Sausage casings(3)Lubricant(3)5% in accordance with paragraph B.01.047(e) (Residues of mineral oil in a raw sausage prepared with such casings not to exceed 200 p.p.m.; in cooked sausage, 30 p.p.m.)(4)Salt Substitute(4)Binding agent and protective coating(4)0.6% in accordance with paragraph B.01.047(h)M.8MonoacetinUnstandardized bakery foodsPlasticizerGood Manufacturing PracticeM.9Mono- and di-glycerides(1)Apple (or rhubarb) and (naming the fruit) Jam; Fats and oils; Fig marmalade; Fig marmalade with pectin; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade; Pineapple marmalade with pectin(1)Antifoaming agent(1)Good Manufacturing Practice(2)Unstandardized foods(2)Antifoaming agent; Humectant; Release agent(2)Good Manufacturing PracticeM.10Mono-glyceridesUnstandardized foodsAntifoaming agent; Humectant; Release agentGood Manufacturing PracticeN.1Nitrogen(1)Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients)(1)To improve spreadability(1)Good Manufacturing Practice(2)Margarine(2)To improve spreadability(2)Good Manufacturing Practice(3)Unstandardized foods(3)Pressure dispensing agent(3)Good Manufacturing PracticeN.2Nitrous OxideUnstandardized foodsPressure dispensing agentGood Manufacturing PracticeO.1Octafluorocyclobu-taneUnstandardized foodsPressure dispensing and aerating agentGood Manufacturing PracticeO.2OxystearinCotton seed oil; Peanut oil; Soy bean oilTo inhibit crystal formation0.125%O.3Ozone(1)Cider(1)Maturing agent(1)Good Manufacturing Practice(2)Water represented as mineral water or spring water(2)Chemosterilant(2)Good Manufacturing Practice(3)Wine(3)Maturing agent(3)Good Manufacturing PracticeP.1Pancreas ExtractAcid producing bacterial culturesTo control bacteriophagesGood Manufacturing PracticeP.1AParaffin Wax(1)Fresh fruits and vegetables(1)Coating(1)0.3% in accordance with section B.01.047(2)Cheese and turnips(2)Coating(2)Good Manufacturing Practice in accordance with section B.01.047P.2Petrolatum(1)Bakery products(1)Release agent(1)0.15% in accordance with section B.01.047. If mineral oil is also used as a release agent the total of any combination of petrolatum and mineral oil must not exceed 0.15%(2)Fresh fruits and vegetables(2)Coating(2)0.3% in accordance with section B.01.047P.2APolyethylene glycol (molecular weight 3000-9000)(1)Soft drinks(1)Antifoaming agent(1)10 p.p.m.(2)Table-top sweetener tablets containing aspartame(2)Lubricant(2)1.0%(3)L-Lysine tablets(3)Tablet binder(3)7.0%P.2BPolydextroseUnstandardized foodsBodying and texturizing agentGood Manufacturing PracticeP.3Polyvinylpyrroli-done(1)Ale; Beer; Cider; Light beer; Malt liquor; Porter; Stout; Wine(1)Fining agent(1)2 p.p.m. in the finished product(2)Table-top sweetener tablets containing aspartame(2)Tablet binder(2)0.3%(3)Colour lake dispersions for use in confectionery in tablet form(3)Viscosity reduction agent and stabilizer in colour lake dispersions(3)Good Manufacturing Practice (Residues of polyvinyl pyroliodone not to exceed 100 p.p.m. in the finished foods)P.4Potassium Aluminum SulphateFlour; Whole wheat flourCarrier of benzoyl peroxide900 p.p.m., in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi)P.4.1Potassium FerrocyanideWineFining agentGood Manufacturing PracticeP.5Potassium Stearate(1)Chewing gum(1)Plasticizing agent(1)Good Manufacturing Practice(2)Emulsifying preparations containing propylene glycol monoesters(2)Stabilizing agent(2)2%P.6PropaneUnstandardized foodsPressure dispensing and aerating agentGood Manufacturing PracticeP.7Propylene Glycol(1)Oil-soluble annatto(1)Solvent(1)Good Manufacturing Practice(2)Unstandardized foods(2)Humectant(2)Good Manufacturing PracticeQ.1Quillaia ExtractBeverage bases; Beverage mixes; Soft drinksFoaming AgentGood Manufacturing PracticeS.1SaponinBeverage bases; Beverage mixes; Soft drinksFoaming agentGood Manufacturing PracticeS.1.01Silicon DioxideEdible vegetable oil-based cookware coating emulsionsSuspending agent2.0% of preparationS.1.1Sodium Acid PyrophosphateFrozen fish fillets; frozen minced fish; frozen lobster; frozen crab; frozen clams; frozen shrimpTo reduce processing losses and to reduce thaw dripUsed in combination with sodium tripolyphosphate and sodium pyrophosphate tetrabasic, total added pyrophosphate not to exceed 0.5% calculated as sodium phosphate, dibasicS.2Sodium Aluminum SulphateFlour; Whole wheat flourCarrier of benzoyl peroxide900 p.p.m. in accordance with subparagraphs B.13.001(e)(vi) and B.13.005(d)(vi)S.3Sodium(1)Confectionery(1)Aerating agent(1)Good Manufacturing PracticeBicarbonate(2)Salt(2)To stabilize potassium iodide in salt(2)Good Manufacturing PracticeS.3ASodium CarbonateIn combination with sodium hexametophosphate for use on frozen fish fillets, frozen lobster, frozen crabs, frozen clams and frozen shrimpTo reduce thaw drip15% of the combination of sodium carbonate and sodium hexametaphosphateS.3BSodium Carboxymethyl CelluloseSausage casingsCoating to enable peeling0.25% of the casingS.4Sodium Citrate(1)Beef blood(1)Anticoagulant(1)0.5%(2)Sour cream(2)Flavour precursor(2)0.1%(3)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(3)To modify texture(3)Good Manufacturing PracticeS.5Sodium Ferrocyanide DecahydrateDendritic saltAs an adjuvant in the production of dendritic salt crystals13 p.p.m. calculated as anhydrous sodium ferrocyanideS.6Sodium Hexameta-(1)Beef blood(1)Anti-coagulant(1)0.2%phosphate(2)Frozen fish fillets; frozen lobsters; frozen crab; frozen clams and frozen shrimp(2)To reduce thaw drip(2)0.5% total added phosphate calculated as sodium phosphate, dibasic(3)Gelatin intended for marshmallow compositions(3)Whipping agent(3)2%S.6ASodium HydroxideFrozen crustaceans and molluscsTo facilitate the removal of extraneous matter and to reduce moisture loss during cookingWhen used in combination with sodium chloride (salt) and calcium oxide in solution, sodium hydroxide not to exceed 70 p.p.m.S.6.1Sodium Lauryl(1)Dried egg white (dried albumen)(1)Whipping agent(1)0.1%Sulphate(2)Liquid egg white (liquid albumen), Frozen egg white (frozen albumen)(2)Whipping agent(2)0.0125%(3)Gelatin intended for marshmallow compositions(3)Whipping agent(3)0.5%S.6.2Sodium Potassium Copper ChlorophyllinBreath freshener products in candy, tablet or gum formTo characterize the product700 p.p.m.S.7Sodium Phosphate, dibasic(1)Frozen fish(1)To prevent cracking of glaze(1)Good Manufacturing Practice(2)Frozen mushrooms(2)To prevent discolouration(2)Good Manufacturing PracticeS.7.1Sodium Pyrophosphate, tetrabasicFrozen fish fillets; frozen minced fish; frozen lobster; frozen crab; frozen clams; frozen shrimpTo reduce processing losses and to reduce thaw dripUsed in combination with sodium tripolyphosphate and sodium acid pyrophosphate, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasicS.8Sodium SilicateCanned drinking waterCorrosion inhibitorGood Manufacturing PracticeS.9Sodium StearateChewing gumPlasticizing agentGood Manufacturing PracticeS.9ASodium Stearoyl-(1)Liquid and frozen egg whites(1)Whipping agent(1)0.05%2-Lactylate(2)Dried egg whites(2)Whipping agent(2)0.5%(3)Oil toppings or topping mixes(3)Whipping agent(3)0.3%(4)Dehydrated potatoes(4)Conditioning agent(4)0.2% of dry weightS.9BSodium SulphateFrozen mushroomsTo prevent discolourationGood Manufacturing PracticeS.9CSodium SulphiteCanned flaked tunaTo prevent discolouration300 p.p.m.S.10Sodium ThiosulphateSaltTo stabilize potassium iodine in saltGood Manufacturing PracticeS.11Sodium TripolyphosphateFrozen fish fillets; frozen minced fish; frozen comminuted fish; frozen lobster; frozen crab; frozen clams and frozen shrimpTo reduce processing losses and to reduce thaw dripUsed singly or in combination with sodium acid pyrophosphate and sodium pyrophosphate tetrabasic, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasicS.12[Repealed, SOR/93-276, s. 8]
S.13Stannous Chloride(1)Asparagus packed in glass containers or fully lined (lacquered) cans(1)Flavour and colour stabilizer(1)25 p.p.m. calculated as tin(2)Canned carbonated soft drinks; concentrated fruit juices except frozen concentrated orange juice; lemon juice; lime juice(2)Flavour and colour stabilizer(2)Good Manufacturing PracticeS.14Stearic Acid(1)Confectionery(1)Release agent(1)Good Manufacturing Practice(2)Chewing gum(2)Plasticizing agent(2)Good Manufacturing Practice(3)Foods sold in tablet form(3)Release agent and lubricant(3)Good Manufacturing PracticeS.15Sodium Methyl SulphatePectinA processing aid, the result of methylation of pectin by sulfuric acid and methyl alcohol and neutralized by sodium bicarbonate0.1% of pectinS.15A[Repealed, SOR/93-276, s. 9]
S.16Sucrose Acetate Isobutyrate(Naming the flavour) Flavour for use in citrus-flavoured or spruce-flavoured beveragesDensity adjusting agent300 p.p.m. in citrus-flavoured or spruce-flavoured beverages as consumedS.17Sulphuric AcidCoffee beansTo improve the extraction yield of coffee solidsGood Manufacturing PracticeT.1Talc(1)Rice(1)Coating agent(1)Good Manufacturing Practice(2)Chewing gum base(2)Filler(2)Good Manufacturing Practice(3)Chewing gum(3)Dusting agent(3)Good Manufacturing PracticeT.2Tannic Acid(1)Chewing gum(1)To reduce adhesion(1)Good Manufacturing Practice(2)Cider; Honey wine; Wine(2)Fining agent(2)200 p.p.mT.2A[Repealed, SOR/93-276, s. 10]
T.3TriacetinCake mixesWetting agentGood Manufacturing PracticeT.4Triethyl CitrateLiquid egg white (liquid albumen); Frozen egg white (frozen albumen)Whipping agent0.25%X.1[Repealed, SOR/93-276, s. 11]
TABLE IX
FOOD ADDITIVES THAT MAY BE USED AS SWEETENERS
Column IColumn IIColumn IIIItemPermittedMaximum LevelNoAdditivein or onof Use A.01Acesulfame-potassium(1) Table-top sweeteners
(1) Good Manufacturing Practice
(2) Carbonated beverages
(2) 0.025% in beverages as consumed
(3) Beverages; Beverage concentrates; Beverage mixes; Dairy beverages; (except for any of these products for which standards are set out in these Regulations)
(3) 0.05% in beverages as consumed
(4) Desserts; Dessert mixes; Toppings; Topping mixes; Fillings; Filling mixes; (except for any of these products for which standards are set out in these Regulations)
(4) 0.1% in products as consumed
(5) Chewing gum; Breath freshener products
(5) 0.35%
(6) Fruit spreads (except for any of these products for which standards are set out in these Regulations)
(6) 0.1%
(7) Salad dressings (except for any of these products for which standards are set out in these Regulations)
(7) 0.05%
(8) Confectionery
(8) 0.25%
(9) Bakery mixes; Bakery products; (except for any of these products for which standards are set out in these Regulations)
(9) 0.1% in products as consumed
(1) Table-top sweeteners
(1) Good Manufacturing Practice
(2) Breakfast cereals
(2) 0.5%
(3) Beverages; Beverage concentrates; Beverage mixes; (except for any of these products for which standards are set out in these Regulations)
(3) 0.1% in beverages as consumed
(4) Desserts; Dessert mixes; Toppings; Topping mixes; Fillings; Filling mixes; (except for any of these products for which standards are set out in these Regulations)
(4) 0.3% in products as consumed
(5) Chewing gum; Breath freshener products
(5) 1.0%
(6) Fruit spreads; Purées and sauces; Table syrups; (except for any of these products for which standards are set out in these Regulations)
(6) 0.2%
(7) Salad dressings; Peanut and other nut spreads; (except for any of these products for which standards are set out in these Regulations)
(7) 0.05%
(8) Condiments (except for any of these products for which standards are set out in these Regulations)
(8) 0.2%
(9) Confectionery glazes for snack foods; Sweetened seasonings or coating mixes for snack foods
(9) 0.1%
(10) Confections and their coatings (except for any of these products for which standards are set out in these Regulations)
(10) 0.3%
Bakery products and baking mixes (except for any of these products for which standards are set out in these Regulations)
0.4% in product as consumed
E.1Erythritol(1) Table-top sweeteners
(1) Good Manufacturing Practice
(2) Dietetic beverages
(2) 3.5%
(3) Fat-based cream fillings and toppings
(3) 60%
(4) Dietetic cookies and wafers
(4) 7%
(5) Soft candies
(5) 40%
(6) Hard candies
(6) 50%
(7) Chewing gum
(7) 60%
Unstandardized foods
Good Manufacturing Practice
I.1IsomaltUnstandardized foods
Good Manufacturing Practice
L.1LactitolUnstandardized foods
Good Manufacturing Practice
M.1MaltitolUnstandardized foods
Good Manufacturing Practice
M.2Maltitol syrupUnstandardized foods
Good Manufacturing Practice
M.3MannitolUnstandardized foods
Good Manufacturing Practice
S.1Sorbitol(1) A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)
(1) 3.5%
(2) Unstandardized foods
(2) Good Manufacturing Practice
Unstandardized foods
Good Manufacturing Practice
S.2Sucralose(1) Table-top sweeteners
(1) Good Manufacturing Practice
(2) Breakfast cereals
(2) 0.1%
(3) Beverages; Beverage concentrates; Beverage mixes; Dairy beverages; (except for any of these products for which standards are set out in these Regulations)
(3) 0.025% in beverages as consumed
(4) Desserts; Dessert mixes; Toppings; Topping mixes; Dairy Desserts; Frozen Desserts; Fillings; Filling mixes; (except for any of these products for which standards are set out in these Regulations)
(4) 0.025% in products as consumed
(5) Chewing gum; Breath freshener products
(5) 0.15%
(6) Fruit spreads (except for any of these products for which standards are set out in these Regulations)
(6) 0.045%
(7) Salad dressings; Condiments; (except for any of these products for which standards are set out in these Regulations)
(7) 0.04%
(8) Confections and their coatings; Confectionery glazes for snack foods; Sweetened seasonings or coating mixes for snack foods; (except for any of these products for which standards are set out in these Regulations)
(8) 0.07%
(9) Baking mixes; Bakery products; (except for any of these products for which standards are set out in these Regulations)
(9) 0.065% in products as consumed
(10) Processed fruit and vegetable products (except for any of these products for which standards are set out in these Regulations)
(10) 0.015%
(11) Alcoholic beverages (except for any of these products for which standards are set out in these Regulations)
(11) 0.07%
(12) Puddings; Pudding mixes
(12) 0.04% in products as consumed
(13) Table syrups (except for any of these products for which standards are set out in these Regulations)
(13) 0.15%
(1) Chewing gum; Breath freshener products
(1) 500 p.p.m.
(2) Salt substitutes
(2) 400 p.p.m.
(3) (naming the flavour) Flavour referred to in section B.10.005; Unstandardized flavouring preparations
(3) 100 p.p.m.
Unstandardized foods
Good Manufacturing Practice
TABLE X
FOOD ADDITIVES THAT MAY BE USED AS PH ADJUSTING AGENTS, ACID-REACTING MATERIALS AND WATER CORRECTING AGENTS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use A.1Acetic Acid(1)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(1)Good Manufacturing Practice(2)Canned Asparagus(2)Good Manufacturing Practice(3)Gelatin(3)Good Manufacturing Practice(4)Unstandardized foods(4)Good Manufacturing PracticeA.2Adipic AcidUnstandardized foodsGood Manufacturing PracticeA.3Ammonium Aluminum(1)Baking powder(1)Good Manufacturing PracticeSulphate(2)Unstandardized foods(2)Good Manufacturing PracticeA.4Ammonium(1)Cocoa products(1)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005Bicarbonate(2)Unstandardized foods(2)Good Manufacturing PracticeA.5Ammonium Carbonate(1)Cocoa products(1)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(2)Unstandardized foods(2)Good Manufacturing PracticeA.6Ammonium Citrate, dibasicUnstandardized foodsGood Manufacturing PracticeA.7Ammonium Citrate, monobasicUnstandardized foodsGood Manufacturing PracticeA.8Ammonium Hydroxide(1)Cocoa products(1)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(2)Gelatin(2)Good Manufacturing Practice(3)Unstandardized foods(3)Good Manufacturing PracticeA.9Ammonium Phosphate, dibasic(1)Ale; Bacterial cultures; Baking powder; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized bakery foods(2)Good Manufacturing PracticeA.10Ammonium Phosphate, monobasic(1)Ale; Bacterial cultures; Baking powder; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized bakery foods(2)Good Manufacturing Practice(3)Uncultured buttermilk(3)0.1%C.1Calcium Acetate(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeC.2Calcium Carbonate(1)Ice cream mix; Ice milk mix; Wine(1)Good Manufacturing Practice(2)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(2)Good Manufacturing Practice(3)Grape juice(3)Good Manufacturing Practice(4)Unstandardized foods(4)Good Manufacturing Practice(5)Cocoa products(5)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005C.3Calcium Chloride(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeC.4Calcium Citrate(1)Infant formula(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeC.5Calcium FumarateUnstandardized foodsGood Manufacturing PracticeC.6Calcium GluconateUnstandardized foodsGood Manufacturing PracticeC.7Calcium Hydroxide(1)Ale; Beer; Ice cream mix; Ice milk mix; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Canned peas(2)0.01%(3)Infant formula(3)Good Manufacturing Practice(4)Grape Juice(4)Good Manufacturing Practice(5)Unstandardized foods(5)Good Manufacturing PracticeC.8Calcium Lactate(1)Baking powder(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeC.9Calcium Oxide(1)Ale; Beer; Ice cream mix; Ice milk mix; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeC.10Calcium Phosphate, dibasicUnstandardized foodsGood Manufacturing PracticeC.11Calcium Phosphate, monobasic(1)Ale; Baking powder; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeC.12Calcium Phosphate, tribasicUnstandardized foodsGood Manufacturing PracticeC.13Calcium SulphateAle; Beer; Light beer; Malt liquor; Porter; Stout; WineGood Manufacturing PracticeC.13ACarbon Dioxide(Naming the variety) CheeseGood Manufacturing PracticeC.14Citric Acid(1)Ale; Apple (or rhubarb) and (naming the fruit) jam; Beer; Canned artichokes; Canned asparagus; Canned bean sprouts; Canned chili peppers; Canned mushrooms; Canned onions; Canned pears; Canned shellfish; Canned spring mackerel; Cider; Cottage cheese; Creamed cottage cheese; Egg white (albumen) and yolk; Liquid, dried or frozen whole egg; Fig marmalade; Fig marmalade with pectin; French dressing; Frozen cooked shrimp; Frozen (naming the fruit); Gelatin; Grape juice; Honey wine; Ice cream mix; Ice milk mix; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Light beer; Malt liquor; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Mayonnaise; Mincemeat; Olives; Peach nectar; Pear nectar; Pineapple marmalade; Pineapple marmalade with pectin; Porter; Salad dressing; Sherbet; Stout; Tomatoes; Wine(1)Good Manufacturing Practice(2)Canned applesauce; Canned grapefruit; Canned mandarin oranges; Canned pears; Canned pineapple; Canned strawberries(2)Sufficient to maintain pH 4.2 to 4.5(3)Infant formula(3)Good Manufacturing Practice(4)Margarine(4)Good Manufacturing Practice(5)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(5)Good Manufacturing Practice(6)Unstandardized foods(6)Good Manufacturing Practice(7)Cocoa products(7)1%, singly or in combination with tartaric acid, calculated on a fat-free basisC.15Cream of TartarSame foods as listed for Potassium Acid TartrateSame levels as prescribed for Potassium Acid TartrateF.1Fumaric Acid(1)Gelatin(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing Practice(3)Wine(3)Good Manufacturing PracticeG.1Gluconic AcidUnstandardized foodsGood Manufacturing PracticeG.2Glucono-delta-lactoneUnstandardized foodsGood Manufacturing PracticeH.1Hydrochloric Acid(1)Ale; Beer; Gelatin; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Infant formula(2)Good Manufacturing PracticeL.1Lactic Acid(1)Ale; Baking powder; Beer; Bread; Cider; Cottage cheese; Creamed cottage cheese; Egg white (albumen) and yolk; Liquid, dried or frozen whole egg; French dressing; Ice cream mix; Ice milk mix; Light beer; Malt liquor; Mayonnaise; Olives; Pickles and Relishes; Porter; Salad dressing; Sherbet; Stout(1)Good Manufacturing Practice(2)Canned pears; Canned strawberries(2)Sufficient to maintain pH 4.2 to 4.5(3)Margarine(3)Good Manufacturing Practice(4)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(4)Good Manufacturing Practice(5)Unstandardized foods(5)Good Manufacturing Practice(6)Wine(6)Good Manufacturing PracticeM.2Magnesium Carbonate(1)Cocoa products(1)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(2)Ice cream mix; Ice milk mix(2)Good Manufacturing Practice(3)Unstandardized foods(3)Good Manufacturing PracticeM.3Magnesium CitrateSoft drinksGood Manufacturing PracticeM.4Magnesium FumarateUnstandardized foodsGood Manufacturing PracticeM.5Magnesium Hydroxide(1)Canned peas(1)0.05%(2)Cocoa products(2)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(3)Gelatin; Ice cream mix; Ice milk mix(3)Good Manufacturing Practice(4)Bacterial cultures(4)Good Manufacturing PracticeM.6Magnesium OxideIce cream mix; Ice milk mixGood Manufacturing PracticeM.6AMagnesium PhosphateBacterial culturesGood Manufacturing PracticeM.7Magnesium Sulphate(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Bacterial cultures(2)Good Manufacturing PracticeM.8Malic Acid(1)Apple (or rhubarb) and (naming the fruit) jam; Apricot nectar; Canned asparagus; Fig marmalade; Fig marmalade with pectin; Frozen (naming the fruit); (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Peach nectar; Pear nectar; Pineapple marmalade; Pineapple marmalade with pectin(1)Good Manufacturing Practice(2)Canned applesauce; Canned pears; Canned strawberries(2)Sufficient to maintain pH 4.2 to 4.5(3)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(3)Good Manufacturing Practice(4)Unstandardized foods(4)Good Manufacturing Practice(5)Wine(5)Good Manufacturing PracticeM.8AManganese SulphateBacterial culturesGood Manufacturing PracticeM.9Metatartaric AcidWine0.01%P.1Phosphoric Acid(1)Ale; Beer; Cottage Cheese; Creamed cottage cheese; Gelatin; Light beer; Malt liquor; Mono-glycerides and mono- and diglycerides; Porter; Stout(1)Good Manufacturing Practice(2)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(2)Good Manufacturing Practice(3)Fish protein(3)Good Manufacturing Practice(4)Unstandardized foods(4)Good Manufacturing Practice(5)Cocoa products(5)0.5%, expressed as P2O5, calculated on a fat-free basisP.2Potassium Acid Tartrate(1)Baking powder; Honey wine(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing Practice(3)Wine(3)0.42%P.3Potassium Aluminum Sulphate(1)Ale; Baking powder; Beer; Light beer; Malt liquor; Oil-soluble annatto; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeP.4Potassium Bicarbonate(1)Baking powder; Malted milk; Malted milk powder(1)Good Manufacturing Practice(2)Cocoa products(2)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(3)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(3)Good Manufacturing Practice(4)Infant formula(4)Good Manufacturing Practice(5)Margarine(5)Good Manufacturing Practice(6)Unstandardized foods(6)Good Manufacturing Practice(7)Wine(7)Good Manufacturing PracticeP.5Potassium Carbonate(1)Cocoa products(1)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(2)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(2)Good Manufacturing Practice(3)Margarine(3)Good Manufacturing Practice(4)Unstandardized foods(4)Good Manufacturing Practice(5)A blend of prepared fish and prepared meat referred to in paragraph B.21.006(n)(5)Good Manufacturing Practice(6)Wine(6)Good Manufacturing PracticeP.6Potassium ChlorideAle; Beer; Light beer; Malt liquor; Porter; StoutGood Manufacturing PracticeP.7Potassium Citrate(1)Infant formula(1)Good Manufacturing Practice(2)Margarine(2)Good Manufacturing Practice(3)Unstandardized foods(3)Good Manufacturing Practice(4)Wine(4)Good Manufacturing PracticeP.8Potassium FumarateUnstandardized foodsGood Manufacturing PracticeP.9Potassium Hydroxide(1)Oil-soluble annatto(1)1.0%(2)Cocoa products(2)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(3)Ice cream mix; Ice milk mix; Pumping pickle; Cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product (Division 14 only)(3)Good Manufacturing Practice(4)Infant formula(4)Good Manufacturing Practice(5)Margarine(5)Good Manufacturing Practice(6)Grape juice(6)Good Manufacturing Practice(7)Unstandardized foods(7)Good Manufacturing PracticeP.9APotassium LactateMargarineGood Manufacturing PracticeP.10Potassium Phosphate, dibasicUnstandardized foodsGood Manufacturing PracticeP.11Potassium SulphateAle; Beer; Light beer; Malt liquor; Porter; StoutGood Manufacturing PracticeP.12Potassium TartrateCiderGood Manufacturing PracticeS.1Sodium AcetateUnstandardized foodsGood Manufacturing PracticeS.2Sodium Acid Pyrophosphate(1)Baking powder(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeS.3Sodium Acid TartrateBaking PowderGood Manufacturing PracticeS.4Sodium Aluminum PhosphateUnstandardized foodsGood Manufacturing PracticeS.5Sodium Aluminum(1)Baking powder(1)Good Manufacturing PracticeSulphate(2)Unstandardized foods(2)Good Manufacturing PracticeS.6Sodium Bicarbonate(1)Apple (or rhubarb) and (naming the fruit) jam; Baking powder; Egg white (albumen) and yolk; Liquid, dried or frozen whole egg; Ice cream mix; Ice milk mix; (naming the fruit) jam; (naming the fruit) jam with pectin; (naming the fruit) jelly; (naming the fruit) jelly with pectin; Malted milk powder; (naming the citrus fruit) marmalade; (naming the citrus fruit) marmalade with pectin; Oil-soluble annatto; Pineapple marmalade or fig marmalade; Pineapple marmalade with pectin or fig marmalade with pectin; Pumping pickle; Cover pickle and dry cure employed in the curing of preserved meat (Division 14) or preserved meat by-product(1)Good Manufacturing Practice(2)Cocoa products(2)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(3)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(3)Good Manufacturing Practice(4)Infant formula(4)Good Manufacturing Practice(5)Margarine(5)Good Manufacturing Practice(6)Unstandardized foods(6)Good Manufacturing PracticeS.7Sodium BisulphateAle; Beer; Light beer; Malt liquor; Porter; StoutGood Manufacturing PracticeS.8Sodium Carbonate(1)Apple (or rhubarb) and (naming the fruit) jam; Egg white (albumen) and yolk; Liquid, dried or frozen whole egg; Gelatin; Ice cream mix; Ice milk mix; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Meat binder for preserved meat and preserved meat by-product (Division 14 only); Pineapple marmalade or fig marmalade; Pineapple marmalade with pectin or fig marmalade with pectin(1)Good Manufacturing Practice(2)Cocoa products(2)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(3)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(3)Good Manufacturing Practice(4)Margarine(4)Good Manufacturing Practice(5)Unstandardized foods(5)Good Manufacturing PracticeS.9Sodium Citrate(1)Apple (or rhubarb) and (naming the fruit) jam; Cottage cheese; Cream; Creamed cottage cheese; Ice cream mix; Ice milk mix; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade or Fig marmalade; Pineapple marmalade with pectin or Fig marmalade with pectin; Sherbet(1)Good Manufacturing Practice(2)Infant formula(2)Good Manufacturing Practice(3)Unstandardized foods(3)Good Manufacturing Practice(4)Margarine(4)Good Manufacturing PracticeS.12Sodium FumarateUnstandardized foodsGood Manufacturing PracticeS.13Sodium GluconateUnstandardized foodsGood Manufacturing PracticeS.14Sodium HexametaphosphateUnstandardized foodsGood Manufacturing PracticeS.15Sodium Hydroxide(1)Cocoa products(1)Sufficient to process the cocoa products in accordance with the requirements of section B.04.005(2)Gelatin; Ice cream mix; Ice milk mix; (naming the flavour) Skim milk; (naming the flavour) Partly skimmed milk; Pumping pickle; Cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product (Division 14 only)(2)Good Manufacturing Practice(3)Infant formula(3)Good Manufacturing Practice(4)Margarine(4)Good Manufacturing Practice(5)Unstandardized foods(5)Good Manufacturing PracticeS.16Sodium Lactate(1)Margarine(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeS.17Sodium Phosphate, dibasic(1)Ale; Bacterial culture; Beer; Cream; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeS.18Sodium Phosphate,(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practicemonobasic(2)Unstandardized foods(2)Good Manufacturing PracticeS.19Sodium Phosphate, tribasic(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeS.20Sodium Potassium Tartrate(1)Apple (or rhubarb) and (naming the fruit) jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Pineapple marmalade or Fig marmalade; Pineapple marmalade with pectin or Fig marmalade with pectin(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing Practice(3)Margarine(3)Good Manufacturing PracticeS.21Sodium Pyrophosphate, tetrabasicUnstandardized foodsGood Manufacturing PracticeS.22Sodium Tripolyphos- phateUnstandardized foodsGood Manufacturing PracticeS.23Sulphuric AcidAle; Beer; Light beer; Malt liquor; Porter; StoutGood Manufacturing PracticeS.24Sulphurous AcidGelatinGood Manufacturing Practice provided the finished product does not contain more than 500 p.p.m. calculated as sulphur dioxideT.1Tartaric Acid(1)Ale; Apple (or rhubarb) and (naming the fruit) jam; Baking powder; Beer; Cider; Canned asparagus; Fig marmalade; Fig marmalade with pectin; French dressing; Honey wine; Ice cream mix; Ice milk mix; (naming the fruit) Jam; (naming the fruit) Jam with pectin; (naming the fruit) Jelly; (naming the fruit) Jelly with pectin; Light beer; Malt liquor; (naming the citrus fruit) Marmalade; (naming the citrus fruit) Marmalade with pectin; Mayonnaise; Pineapple marmalade; Pineapple marmalade with pectin; Porter; Salad dressing; Sherbet; Stout; Wine(1)Good Manufacturing Practice(2)Canned pears; Canned strawberries(2)Sufficient to maintain pH 4.2 to 4.5(3)Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients); (named variety) Whey cheese(3)Good Manufacturing Practice(4)Margarine(4)Good Manufacturing Practice(5)Unstandardized foods(5)Good Manufacturing Practice(6)Cocoa products(6)1%, singly or in combination with citric acid, calculated on a fat-free basisTABLE XI
PART IFOOD ADDITIVES THAT MAY BE USED AS CLASS I PRESERVATIVESColumn IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use A.1Acetic Acid(1)Preserved fish; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeA.2Ascorbic Acid(1)Ale; Beer; Canned mushrooms; Canned tuna; Canned white asparagus; Cider; Frozen fruit; Glaze of Frozen fish; Headcheese; Light beer; Malt liquor; Meat binder for preserved meat and preserved meat by-product (Division 14 only); Porter; Preserved fish; Frozen minced fish; Frozen comminuted fish; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Pumping pickle; Cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product; Stout; Wine(1)Good Manufacturing Practice(2)Canned applesauce(2)If used either singly or in combination with Iso-Ascorbic Acid, the total not to exceed 150 p.p.m.(3)Canned peaches(3)550 p.p.m.(4)Unstandardized foods(4)Good Manufacturing practiceC.1Calcium AscorbateSame foods as listed for Ascorbic AcidSame levels as prescribed for Ascorbic AcidE.1Erythorbic Acid(1)Ale; Beer; Cider; Frozen fruit; Headcheese; Light beer; Malt liquor; Meat binder for preserved meat and preserved meat by-product (Division 14 only); Porter; Preserved fish; Frozen minced fish; Frozen comminuted fish; Glaze of frozen fish; Preserved meat; Preserved meat by-product; Preserved poultry meat; Preserved poultry meat by-product; Pumping pickle; Cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product; Stout; Wine(1)Good Manufacturing Practice(2)Canned applesauce(2)If used either singly or in combination with Ascorbic Acid, the total not to exceed 150 p.p.m.(3)Unstandardized foods(3)Good Manufacturing PracticeI.1Iso-Ascorbic AcidSame foods as listed for Erythorbic AcidSame levels as prescribed for Erythorbic AcidP.1Potassium Nitrate(1)Meat binder for dry sausage, semi-dry sausage, preserved meat and preserved meat by-products prepared by slow cure processes (Division 14)(1)When the meat binder is used in accordance with label instructions, whether potassium nitrate is added alone or in combination with sodium nitrate, the total amount of such nitrates thereby added to each batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation(2)Cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products prepared by slow cure processes (Division 14)(2)When the cover pickle or dry cure is used in accordance with label instructions, whether potassium nitrate is added alone or in combination with sodium nitrate, the total amount of such nitrates thereby added to each batch of preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation(3)Dry sausage, semi-dry sausage, preserved meat and preserved meat by-products prepared by slow cure processes (Division 14)(3)Where potassium nitrate is added alone or in combination with sodium nitrate, the total amount of such nitrates added to each batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.32 ounces per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation(4)Ripened cheese, containing not more than 68% moisture on a fat free basis during manufacture of which the lactic acid fermentation and salting is completed later than 12 hours after coagulation of the curd by food enzymes and where the added salt is applied externally to the cheese as dry salt or in the form of brine(4)If used singly or in combination with sodium nitrate, the total not to exceed 200 p.p.m. (based in milk). Residue in the finished cheese not to exceed 50 p.p.m.(5)Mold ripened cheese packed in hermetically sealed containers(5)If used singly or in combination with sodium nitrate, the total not to exceed 200 p.p.m. (based in milk). Residue in the finished cheese not to exceed 50 p.p.m.P.2Potassium Nitrite(1)Meat binder, pumping pickle, cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products (Division 14)(1)When the meat binder, pumping pickle, cover pickle or dry cure is used in accordance with label instructions, whether potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites thereby added to each batch of preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million calculated prior to any smoking, cooking or fermentation(2)Preserved meat except side bacon and preserved meat by-products (Division 14)(2)Where potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites added to each batch of preserved meat, except side bacon or preserved meat by-products, shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation(3)Side bacon(3)Where potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites added to each batch of side bacon shall not exceed 0.19 ounce per 100 pounds or 120 parts per million, calculated prior to any smoking, cooking or fermentation(4)Preserved poultry meat and preserved poultry meat by-products (Division 22)(4)Where potassium nitrite is added alone or in combination with sodium nitrite, the total amount of such nitrites added to each batch of preserved poultry meat or preserved poultry meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentationS.1Sodium AscorbateSame foods as listed for Ascorbic AcidSame levels as prescribed for Ascorbic AcidS.2Sodium Erythorbate(1)Same foods as listed for Erythorbic Acid(1)Same levels as prescribed for Erythorbic Acid(2)Canned clams(2)350 p.p.m.S.3Sodium Iso-AscorbateSame foods as listed for Erythorbic AcidSame levels as prescribed for Erythorbic AcidS.4Sodium Nitrate(1)Meat binder for dry sausage, semi-dry sausage, preserved meat and preserved meat by-products prepared by slow cure processes (Division 14)(1)When the meat binder is used in accordance with label instructions, whether sodium nitrate is added alone or in combination with potassium nitrate, the total amount of such nitrates thereby added to each batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation(2)Cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products prepared by slow cure processes (Division 14)(2)When the cover pickle or dry cure is used in accordance with label instructions, whether sodium nitrate is added alone or in combination with potassium nitrate, the total amount of such nitrates thereby added to each batch of preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation(3)Dry sausage, semi-dry sausage, preserved meat and preserved meat by-products prepared by the slow cure processes (Division 14)(3)Where sodium nitrate is added alone or in combination with potassium nitrate, the total amount of such nitrates added to each batch of dry sausage, semi-dry sausage, preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation(4)Ripened cheese, containing not more than 68% moisture on a fat free basis during manufacture of which the lactic acid fermentation and salting is completed later than 12 hours after coagulation of the curd by food enzymes and where the added salt is applied externally to the cheese as dry salt or in the form of brine(4)If used singly or in combination with potassium nitrate, the total not to exceed 200 p.p.m. (based in milk). Residue in the finished cheese not to exceed 50 p.p.m.(5)Mold ripened cheese packed in hermetically sealed containers(5)If used singly or in combination with potassium nitrate, the total not to exceed 200 p.p.m. (based in milk). Residue in the finished cheese not to exceed 50 p.p.m.S.5Sodium Nitrite(1)Meat binder, pumping pickle, cover pickle and dry cure employed in the curing of preserved meat and preserved meat by-products (Division 14)(1)When the meat binder, pumping pickle, cover pickle or dry cure is used in accordance with label instructions, whether sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites thereby added to each batch of preserved meat or preserved meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation(2)Preserved meat, except side bacon, and preserved meat by-products (Division 14)(2)Where sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites added to each batch of preserved meat, except side bacon or preserved meat by-products, shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentation(3)Side bacon(3)Where sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites added to each batch of side bacon shall not exceed 0.19 ounce per 100 pounds or 120 parts per million, calculated prior to any smoking, cooking or fermentation(4)Preserved poultry meat and preserved poultry meat by-products (Division 22)(4)Where sodium nitrite is added alone or in combination with potassium nitrite, the total amount of such nitrites added to each batch of preserved poultry meat or preserved poultry meat by-products shall not exceed 0.32 ounce per 100 pounds or 200 parts per million, calculated prior to any smoking, cooking or fermentationW.1Wood Smoke(1)(named variety) Cheese; Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(1)Good Manufacturing Practice(2)Preserved fish; Preserved meat (Divisions 14 and 21); Preserved meat by-product (Divisions 14 and 21); Preserved poultry meat; Preserved poultry meat by-product; Sausage(2)Good Manufacturing Practice(3)Unstandardized foods(3)Good Manufacturing PracticePART IIFOOD ADDITIVES THAT MAY BE USED AS CLASS II PRESERVATIVESColumn IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use B.1Benzoic Acid(1)Apple (or rhubarb) and (naming the fruit) jam; Fig marmalade with pectin; Fruit juices except frozen concentrated orange juice; (naming the fruit) jam; (naming the fruit) jam with pectin; (naming the fruit) jelly with pectin; Marinated or similar cold-processed packaged fish and meat (Division 21); (naming the citrus fruit) marmalade with pectin; Mincemeat; Pickles and relishes; Pineapple marmalade with pectin; Tomato catsup; Tomato paste; Tomato pulp; Tomato puree(1)1,000 p.p.m.(2)Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except in food recognized as a source of thiamine and except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Item
No.
AdditivePermitted in or UponMaximum Level of Use C.1Calcium Propionate(1)Same foods as listed for Propionic Acid(1)2,000 p.p.m. calculated as Propionic Acid(2)Soft flour tortillas(2)4,000 p.p.m.C.2Calcium SorbateSame foods as listed for Sorbic AcidSame maximum levels of use as listed for Sorbic AcidN.1Natamycin(1)The surface of (named variety) cheese and cheddar cheese(1)20 p.p.m. in accordance with the requirements of sections B.08.033 and B.08.034(2)The surface of grated or shredded (named variety) cheese and grated or shredded cheddar cheese(2)10 p.p.m. in accordance with the requirements of sections B.08.033 and B.08.034P.1Potassium Sorbate(1)Same foods as listed for Sorbic Acid(1)Same maximum levels of use as listed for Sorbic Acid(2)Soft flour tortillas(2)5,000 p.p.m.P.2Propionic Acid(1)Bread(1)2,000 p.p.m.(2)(named variety) Cheese; Cheddar cheese; Cream cheese; Cream cheese with (named added ingredients); Cream cheese spread; Cream cheese spread with (named added ingredients); Processed (named variety) cheese; Processed (named variety) cheese with (named added ingredients); Processed cheese food; Processed cheese food with (named added ingredients); Processed cheese spread; Processed cheese spread with (named added ingredients); Cold-pack (named variety) cheese; Cold-pack (named variety) cheese with (named added ingredients); Cold-pack cheese food; Cold-pack cheese food with (named added ingredients)(2)2,000 p.p.m. or 3,000 p.p.m., as the case may be, in accordance with the requirements of sections B.08.033, B.08.034, B.08.035, B.08.037, B.08.038, B.08.039, B.08.040, B.08.041, B.08.041.1, B.08.041.2, B.08.041.3, B.08.041.4, B.08.041.5, B.08.041.6, B.08.041.7 and B.08.041.8(3)Unstandardized foods except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-products
Item
No.
AdditivePermitted in or UponMaximum Level of Use A.1Ascorbic Acid(1)Fats and oils; Lard; Monoglycerides and diglycerides; Shortening(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeA.2Ascorbyl Palmitate(1)Fats and oils; Lard; Monoglycerides and diglycerides; Shortening(1)Good Manufacturing Practice(2)Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Other unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Other unstandardized foods [except unstandardized preparations of
(a) meat and meat by-products (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
Unstandardized foods [except unstandardized preparations of
(a) meat and meat by-product (Divisions 14 and 21);
(b) fish; and
(c) poultry meat and poultry meat by-product]
TABLE XII
FOOD ADDITIVES THAT MAY BE USED AS SEQUESTERING AGENTS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use A.1Ammonium Citrate, dibasicUnstandardized foodsGood Manufacturing PracticeA.2Ammonium Citrate, monobasicUnstandardized foodsGood Manufacturing PracticeC.1Calcium CitrateUnstandardized foodsGood Manufacturing PracticeC.2Calcium Disodium(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)25 p.p.m. calculated as the anhydrous formEthylenediamine- tetraacetate(2)French dressing; Mayonnaise; Salad dressing; Unstandardized dressings and sauces(2)75 p.p.m. calculated as the anhydrous form(3)Potato salad; Sandwich spread(3)100 p.p.m. calculated as the anhydrous form(4)Canned shrimp; Canned tuna(4)250 p.p.m. calculated as the anhydrous form(5)Canned crabmeat; Canned lobster; Canned salmon(5)275 p.p.m. calculated as the anhydrous form(6)Margarine(6)75 p.p.m. calculated as the anhydrous form(7)Canned clams(7)340 p.p.m. calculated as the anhydrous form(8)Canned ripe lima beans (butter beans); Canned pinto beans(8)130 p.p.m calculated as the anhydrous form and in accordance with the requirements of subparagraph B.11.002(d)(vi)(9)Canned snails; Canned sea snails(9)300 p.p.m. calculated as the anhydrous form(10)Canned fava beans(10)365 p.p.m. calculated as the anhydrous form and in accordance with the requirements of subparagraph B.11.002(d)(vi.1)(11)Soft drinks; Ready-to-drink teas(11)33 p.p.m. calculated as the anhydrous form(12)Pasteurized sous-vide potatoes(12)100 p.p.m., singly or in combination with disodium EDTA, calculated as anhydrous disodium EDTAC.3Calcium Disodium EDTASame foods as listed for Calcium Disodium EthylenediaminetetraacetateSame levels as prescribed for Calcium Disodium EthylenediaminetetraacetateC.4Calcium Phosphate, monobasic(1)Ice cream mix; Ice milk mix; Sherbet(1)Good Manufacturing Practice(2)Unstandardized dairy products(2)Good Manufacturing PracticeC.5Calcium Phosphate, tribasicIce cream mix; Ice milk mixGood Manufacturing PracticeC.6Calcium PhytateGlazed fruitGood Manufacturing PracticeC.7Citric Acid(1)Pumping pickle, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing Practice(3)Frozen fish fillets; frozen minced fish; frozen comminuted fish(3)0.1%D.1Disodium Ethylenediaminetetra- acetate(1)Dressing and sauces(1)70 p.p.m.(2)Sandwich spread(2)90 p.p.m(3)Canned red kidney beans; Canned chick peas (garbanzo beans); Canned black-eye peas(3)150 p.p.m in accordance with the requirements of subparagraph B.11.002(d)(vii)(4)Dried banana products(4)265 p.p.m(5)Aqueous suspensions of colour lake preparations for use in coating confectionery tablets(5)1% of the colour preparation(6)Pasteurizedsous-vide
potatoes(6)100 p.p.m., singly or in combination with calcium disodium EDTA, calculated as anhydrous disodium EDTAD.2Disodium EDTASame foods as listed for Disodium Ethylenediaminete-traacetateSame levels as prescribed for Disodium EthylenediaminetetraacetateG.1GlycineMono- and diglycerides0.02%P.1Phosphoric AcidMono- and diglycerides0.02%P.2Potassium Phosphate, monobasic(1)Ice cream mix; Ice milk mix; Sherbet(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing Practice(3)Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product(3)0.5% total added phosphate, calculated as sodium phosphate, dibasicP.3Potassium Pyrophosphate, tetrabasic(1)Meat tenderizers(1)Good Manufacturing Practice(2)Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product(2)0.5% total added phosphate, calculated as sodium phosphate, dibasicP.4Potassium Phosphate, dibasicSolid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product0.5% total added phosphate, calculated as sodium phosphate, dibasicS.1Sodium Acid Pyrophosphate(1)Canned seafoods(1)Used singly or in combination with sodium hexametaphosphate or sodium tripolyphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic(2)Ice cream mix; Ice milk mix(2)Good Manufacturing Practice(3)Injection or cover solution for the curing of poultry or poultry meat(3)Good Manufacturing Practice, and in accordance with B.22.021(e)(4)Pumping pickle for the curing of pork, beef and lamb cuts(4)Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)(5)Unstandardized foods(5)Good Manufacturing Practice(6)Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product(6)0.5% total added phosphate, calculated as sodium phosphate, dibasicS.2Sodium Citrate(1)Ice cream mix; Ice milk mix; Sherbet; Pumping pickle, Cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product(1)Good Manufacturing Practice(2)Unstandardized foods(2)Good Manufacturing PracticeS.3Sodium Hexametaphos- phate(1)Canned seafoods(1)Used singly or in combination with sodium acid pyrophosphate or sodium tripolyphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasic(2)Ice cream mix; Ice milk mix(2)Good Manufacturing Practice(3)Injection or cover solution for the curing of poultry or poultry meat(3)Good Manufacturing Practice, and in accordance with B.22.021(e)(4)Pumping pickle for the curing of pork, beef and lamb cuts(4)Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)(5)Unstandardized foods(5)Good Manufacturing Practice(6)Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product(6)0.5% total added phosphate, calculated as sodium phosphate, dibasicS.4Sodium Phosphate, dibasic(1)Ice cream mix; Ice milk mix; Sherbet(1)Good Manufacturing Practice(2)Injection or cover solution for the curing of poultry or poultry meat(2)Good Manufacturing Practice, and in accordance with B.22.021(e)(3)Pumping pickle for the curing of pork, beef and lamb cuts(3)Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)(4)Unstandardized foods(4)Good Manufacturing Practice(5)Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product(5)0.5% total added phosphate, calculated as sodium phosphate, dibasicS.5Sodium Phosphate, monobasic(1)Ice cream mix; Ice milk mix; Sherbet(1)Good Manufacturing Practice(2)Injection or cover solution for the curing of poultry or poultry meat(2)Good Manufacturing Practice, and in accordance with B.22.021(e)(3)Pumping pickle for the curing of pork, beef and lamb cuts(3)Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)(4)Unstandardized foods(4)Good Manufacturing Practice(5)Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product(5)0.5% total added phosphate, calculated as sodium phosphate, dibasicS.6Sodium Pyrophosphate, tetrabasic(1)Ice cream mix; Ice milk mix; Sherbet(1)Good Manufacturing Practice(2)Meat tenderizers(2)Good Manufacturing Practice(3)Injection or cover solution for the curing of poultry or poultry meat(3)Good Manufacturing Practice, and in accordance with B.22.021(e)(4)Pumping pickle for the curing of pork, beef and lamb cuts(4)Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)(5)Unstandardized foods(5)Good Manufacturing Practice(6)Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product(6)0.5% total added phosphate, calculated as sodium phosphate, dibasicS.7Sodium Tripolyphos- phate(1)Injection or cover solution for the curing of poultry or poultry meat(1)Good Manufacturing Practice, and in accordance with B.22.021(e)(2)Meat tenderizers(2)Good Manufacturing Practice(3)Pumping pickle for the curing of pork, beef and lamb cuts(3)Good Manufacturing Practice, and in accordance with B.14.009(f) and B.14.031(h)(4)Unstandardized foods(4)Good Manufacturing Practice(5)Solid cut meat; prepared meat; prepared meat by-product; solid cut poultry meat; prepared poultry meat; prepared poultry meat by-product(5)0.5% total added phosphate, calculated as sodium phosphate, dibasic(6)Canned seafoods(6)Used singly or in combination with sodium acid pyrophosphate or sodium hexametaphosphate, or both, total added phosphate not to exceed 0.5% calculated as sodium phosphate, dibasicS.8Stearyl CitrateMargarine0.01% of the fat content. If monoglyceride citrate or monoisopropyl citrate or both are also used, the total must not exceed 0.01% of the fat contentTABLE XIII
FOOD ADDITIVES THAT MAY BE USED AS STARCH MODIFYING AGENTS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use A.1Acetic AnhydrideStarchGood Manufacturing PracticeA.2Adipic AcidStarchGood Manufacturing PracticeA.3Aluminum SulphateStarchGood Manufacturing PracticeE.1EpichlorhydrinStarchGood Manufacturing PracticeH.1Hydrochloric AcidStarchGood Manufacturing PracticeH.2Hydrogen PeroxideStarchGood Manufacturing PracticeM.1Magnesium SulphateStarch0.4%N.1Nitric AcidStarchGood Manufacturing PracticeO.1Octenyl Succinic AnhydrideStarchGood Manufacturing PracticeP.1Peracetic AcidStarchGood Manufacturing PracticeP.2Phosphorus OxychlorideStarchGood Manufacturing PracticeP.3Potassium PermanganateStarch50 p.p.m. of Manganese Sulphate calculated as ManganeseP.4Propylene OxideStarch25%S.1Sodium AcetateStarchGood Manufacturing PracticeS.2Sodium BicarbonateStarchGood Manufacturing PracticeS.3Sodium CarbonateStarchGood Manufacturing PracticeS.4Sodium ChloriteStarchGood Manufacturing PracticeS.5Sodium HydroxideStarchGood Manufacturing PracticeS.6Sodium HypochloriteStarchGood Manufacturing PracticeS.7Sodium TrimetaphosphateStarch400 p.p.m. calculated as PhosphorusS.7ASodium TripolyphosphateStarchTotal residual phosphate not to exceed 0.4% (calculated as Phosphorus)S.8Succinic AnhydrideStarchGood Manufacturing PracticeS.9Sulphuric AcidStarchGood Manufacturing PracticeTABLE XIV
FOOD ADDITIVES THAT MAY BE USED AS YEAST FOODS
Column IColumn IIColumn IIIItem
No.
AdditivePermitted in or UponMaximum Level of Use A.1Ammonium Chloride(1)Flour; Whole wheat flour(1)2,000 p.p.m. of the flour(2)Bread(2)2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m)(3)Unstandardized foods(3)Good Manufacturing PracticeA.2Ammonium Phosphate, dibasic(1)Bread(1)2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m)(2)Cider; Honey wine; Wine(2)Good Manufacturing Practice(3)Unstandardized bakery foods(3)Good Manufacturing PracticeA.3Ammonium Phosphate, monobasic(1)Bread(1)2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m)(2)Ale; Beer; Cider; Honey wine; Light beer; Malt liquor; Porter; Stout; Wine(2)Good Manufacturing Practice(3)Unstandardized bakery foods(3)Good Manufacturing PracticeA.4Ammonium Sulphate(1)Bread(1)2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m)(2)Cider; Honey wine; Wine(2)Good Manufacturing Practice(3)Unstandardized bakery foods(3)Good Manufacturing PracticeC.1Calcium Carbonate(1)Bread(1)2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m)(2)Unstandardized bakery foods(2)Good Manufacturing PracticeC.2Calcium ChlorideUnstandardized bakery foodsGood Manufacturing PracticeC.3Calcium CitrateUnstandardized bakery foodsGood Manufacturing PracticeC.4Calcium Lactate(1)Bread(1)2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m)(2)Unstandardized bakery foods(2)Good Manufacturing PracticeC.5Calcium Phosphate, dibasic(1)Bread(1)2,500 p.p.m. of the flour. For combinations see paragraph B.13.021(m)(2)Unstandardized bakery foods(2)Good Manufacturing PracticeC.6Calcium Phosphate, monobasic(1)Bread(1)7,500 p.p.m. of flour. For combinations see paragraph B.13.021(m)(2)Flour(2)7,500 p.p.m. of flour(3)Unstandardized bakery foods(3)Good Manufacturing PracticeC.7Calcium Phosphate, tribasicUnstandardized bakery foodsGood Manufacturing PracticeC.8Calcium Sulphate(1)Bread(1)5,000 p.p.m. of the flour(2)Unstandardized foods(2)Good Manufacturing PracticeF.1Ferrous SulphateBacterial culturesGood Manufacturing PracticeM.1Manganese SulphateAle; Beer; Light beer; Malt liquor; Porter; StoutGood Manufacturing PracticeP.1Phosphoric AcidAle; Beer; Light beer; Malt liquor; Porter; StoutGood Manufacturing PracticeP.2Potassium Chloride(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Unstandardized bakery foods(2)Good Manufacturing PracticeP.4Potassium Phosphate, dibasic(1)Ale; Beer; Cider; Honey wine; Light beer; Malt liquor; Porter; Stout; Wine(1)Good Manufacturing Practice(2)Unstandardized bakery foods(2)Good Manufacturing PracticeP.5Potassium Phosphate, monobasicAle; Beer; Cider; Honey wine; Light beer; Malt liquor; Porter; Stout; WineGood Manufacturing PracticeS.1Sodium SulphateUnstandardized bakery foodsGood Manufacturing PracticeU.1[Repealed, SOR/87-5, s. 1]
Z.1Zinc Sulphate(1)Ale; Beer; Light beer; Malt liquor; Porter; Stout(1)Good Manufacturing Practice(2)Bacterial cultures(2)Good Manufacturing PracticeTABLE XV
FOOD ADDITIVES THAT MAY BE USED AS CARRIER OR EXTRACTION SOLVENTS
Column IColumn IIColumn IIIColumn IVItem
No.
AdditivePermitted in or UponMaximum ResidueMaximum Level of Use 1Acetone(1)Spice extracts; Natural extractives(1)30 p.p.m.(2)Meat and Egg Marking Inks(2)Good Manufacturing Practice2Benzyl Alcohol(1)(naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing Practice31,3-Butylene Glycol(1)(naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing Practice3.1Carbon Dioxide(1)Green coffee beans and tea leaves for decaffeination purposes(1)Good Manufacturing Practice(2)Spice extracts; Natural extractives; (naming the flavour) Flavour (Division 10); Hop extract in accordance with subparagraph B.02.130(b)(v) and paragraph B.02.133(b); Pre-isomerized hop extract in accordance with subparagraph B.02.134(1)(a)(ii)(2)Good Manufacturing Practice(3)Egg Products(3)Good Manufacturing Practice(4)Cocoa powder(4)Good Manufacturing Practice4Castor OilOil-soluble annatto; Annatto butter colour; Annatto margarine colourGood Manufacturing Practice5Ethyl Acetate(1)Spice extracts; Natural extractives; (naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing Practice(3)Green coffee beans for decaffeination purposes(3)10 p.p.m. in both roasted and decaffeinated soluble (instant) coffee(4)Tea leaves for decaffeination purposes(4)50 p.p.m.6Ethyl Alcohol (Ethanol)(1)Spice extracts; Natural extractives; (naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing Practice(3)Colour mixtures and preparations (Division 6)(3)Good Manufacturing Practice(4)Meat and Egg Marking Inks(4)Good Manufacturing Practice(5)Food additive preparations(5)Good Manufacturing Practice(6)Hop extract in accordance with subparagraph B.02.130(b)(v) and paragraph B.02.133(b); Pre-isomerized hop extract in accordance with subparagraph B.02.134(1)(a)(iii)(6)Good Manufacturing Practice6.AEthyl alcohol denatured with methanolVegetable oil seed meals10 p.p.m. methanol7[Repealed, SOR/82-406, s. 1]
8Glycerol (Glycerin)(1)(naming the flavour) Extract; (naming the flavour) Essence; (naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing Practice(3)Colour mixtures and preparations (Division 6)(3)Good Manufacturing Practice(4)Food additive preparations(4)Good Manufacturing Practice9Glyceryl diacetate(1)(naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing Practice10Glyceryl triacetate (Triacetin)(1)(naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing Practice11Glyceryl tributyrate (Tributyrin)(1)(naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing Practice12Hexane(1)Spice extracts; Natural extractives(1)25 p.p.m.(2)Hop extract in accordance with subparagraph B.02.130(b)(v) and paragraph B.02.133(a)(2)2.2%(3)Vegetable fats and oils(3)10 p.p.m.(4)Vegetable oil seed meals(4)10 p.p.m.(5)Pre-isomerized hop extract in accordance with subparagraph B.02.134(1)(a)(i) and subsection B.02.134(2)(5)1.5 p.p.m. per percent iso-alpha acid content of the pre-isomerized hop extract13Isopropyl alcohol (Isopropanol)(1)Spice extracts; Natural extractives(1)50 p.p.m.(2)Fish protein(2)0.15%(3)(naming the flavour) Flavour (Division 10)(3)Good Manufacturing Practice(4)Unstandardized flavouring preparations(4)Good Manufacturing Practice(5)Meat and Egg Marking Inks(5)Good Manufacturing Practice14Methyl Alcohol (methanol)(1)Spice extracts; Natural extractives(1)50 p.p.m.(2)Hop extract in accordance with subparagraph B.02.130(b)(v) and paragraph B.02.133(a)(2)2.2%(3)Meat and Egg Marking Inks(3)Good Manufacturing Practice14.1Methyl ethyl ketone (2-Butanone)Spice extracts; Natural extractives50 p.p.m.15Methylene Chloride (Dichloro-methane)(1)Spice extracts; Natural extractives(1)30 p.p.m.(2)Hop extract in accordance with subparagraph B.02.130(b)(v) and paragraph B.02.133(a)(2)2.2% in hop extract(3)Green coffee beans and Tea leaves for decaffeination purposes(3)10 p.p.m. in decaffeinated roasted coffee, decaffeinated soluble (instant) coffee, decaffeinated tea leaves and decaffeinated instant tea16Monoglycerides and diglycerides(1)(naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Oil-soluble annatto; Annatto butter colour; Annatto margarine colour(2)Good Manufacturing Practice(3)Unstandardized flavouring preparations(3)Good Manufacturing Practice(4)Food additive preparations(4)Good Manufacturing Practice17Monoglyceride citrate(1)Spice extracts; Natural extractives(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing Practice182-NitropropaneVegetable oils0.5 p.p.m.191,2-Propylene glycol (1,2-propanediol)(1)(naming the flavour) Extract; (naming the flavour) Essence; (naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Oil-soluble annatto; Annatto butter colour; Annatto margarine colour(2)Good Manufacturing Practice(3)Unstandardized flavouring preparations(3)Good Manufacturing Practice(4)Colour mixtures and preparations (Division 6)(4)Good Manufacturing Practice(5)Food additive preparations(5)Good Manufacturing Practice20Propylene glycol mono-esters and diesters of fat-forming fatty acidsOil-soluble annatto; Annatto butter colour; Annatto margarine colourGood Manufacturing Practice21Triethyl-citrate(1)(naming the flavour) Flavour (Division 10)(1)Good Manufacturing Practice(2)Unstandardized flavouring preparations(2)Good Manufacturing PracticeDIVISION 17
Salt
B.17.001 (1) [S]. Salt, other than crude rock salt, shall be crystalline sodium chloride and may contain
(a) one or more of the following anti-caking agents,
(i) calcium aluminum silicate, calcium phosphate tribasic, calcium silicate, calcium stearate, magnesium carbonate, magnesium silicate, magnesium stearate, silicon dioxide and sodium aluminum silicate, the total amount not to exceed one per cent and, in the case of fine grained salt, the total amount not to exceed two per cent,
(ii) propylene glycol in an amount not exceeding 0.035 per cent, and
(iii) sodium ferrocyanide decahydrate in an amount not exceeding 13 parts per million calculated as anhydrous sodium ferrocyanide;
(b) not more than
(i) 1.4 per cent, singly or in combination, of calcium sulphate or potassium chloride,
(ii) 13 parts per million anhydrous sodium ferrocyanide when added as sodium ferrocyanide decahydrate in the production of dendritic crystals of salt,
(iii) 10 parts per million of polyoxyethylene (20) sorbitan monooleate when used in the production of coarse crystal salt,
(iv) 15 parts per million of sodium alginate when used in the production of coarse crystal salt, and
(v) 0.1 per cent other ingredients; and
(c) notwithstanding paragraphs (a) and (b), the total level of sodium ferrocyanide decahydrate, whether added as an anti-caking agent or as an adjuvant in the production of dendritic salt, shall not exceed 13 parts per million, calculated as anhydrous sodium ferrocyanide.
(2) [Repealed, SOR/97-151, s. 26]
B.17.002 [Repealed, SOR/79-662, s. 18]
B.17.003 Notwithstanding section B.17.001, salt for table or general household use shall contain 0.01 per cent potassium iodide, with or without dextrose, sodium thiosulphate or sodium bicarbonate as a stabilizer of the iodide and the presence of iodide shall be shown on the principal display panel.
Division 18
Sweetening Agents
B.18.001 [S]. Sugar
(a) shall be the food chemically known as sucrose; and
(b) shall contain not less than 99.8 per cent sucrose.
B.18.002 [S]. Liquid Sugar shall be the food obtained by dissolving sugar in water.
B.18.003 [S]. Invert Sugar shall be the food obtained by the partial or complete hydrolysis of sugar.
B.18.004 [S]. Liquid Invert Sugar shall be the food consisting of a solution of invert sugar in water.
B.18.005 [S]. No person shall sell liquid sugar or liquid invert sugar unless the label carries a statement of the percentage of sugar or invert sugar contained therein.
B.18.006 [S]. Icing Sugar
(a) shall be powdered sugar; and
(b) may contain
(i) food colour, and
(ii) either not more than five per cent starch or an anticaking agent.
B.18.007 [S]. Brown Sugar, Yellow Sugar or Golden Sugar
(a) shall be the food obtained from the syrups originating in the sugar refining process;
(b) may contain not more than
(i) 4.5 per cent moisture, and
(ii) 3.5 per cent sulphate ash; and
(c) shall not contain less than 90 per cent sugar and invert sugar.
B.18.008 [S]. Refined Sugar Syrup, Refiners’ Syrup or Golden Syrup
(a) shall be the food made from syrup originating in the sugar refining process;
(b) may be hydrolyzed; and
(c) shall not contain more than
(i) 35 per cent moisture, and
(ii) 2.5 per cent sulphated ash.
B.18.009 [S]. Fancy Molasses
(a) shall be the syrupy food obtained by the evaporation and partial inversion of the clarified or unclarified sugar cane juice from which sugar has not been previously extracted;
(b) may contain sulphurous acid or its salts; and
(c) shall not contain more than
(i) 25 per cent moisture, and
(ii) 3 per cent sulphated ash.
B.18.010 [S]. Table Molasses
(a) shall be the liquid food obtained in the process of manufacturing raw or refined sugar;
(b) may contain sulphurous acid or its salts;
(c) shall not contain more than
(i) 25 per cent moisture, and
(ii) 3 per cent sulphated ash.
B.18.011 [S]. Refiners’ Molasses, Blackstrap Molasses or Cooking Molasses
(a) shall be the residual liquid food obtained in the process of manufacturing raw or refined sugar;
(b) may contain sulphurous acid or its salts;
(c) shall not contain more than
(i) 25 per cent moisture, and
(ii) 12 per cent sulphated ash.
B.18.015 [S]. (1) Dextrose Anhydrous, for the purpose of Part B of these Regulations
(a) shall be the food chemically known as dextrose;
(b) shall contain not less than 99.5 per cent D-glucose on a dry basis;
(c) shall contain not more than 0.25 per cent sulphated ash on a dry basis;
(d) shall contain not less than 98 per cent total solids; and
(e) may contain sulphurous acid or its salts.
(2) Dextrose Monohydrate, for the purpose of Part B of these Regulations
(a) shall be the food chemically known as dextrose;
(b) shall contain not less than 99.5 per cent D-glucose on a dry basis;
(c) shall contain not more than 0.25 per cent sulphated ash on a dry basis;
(d) shall contain not less than 90 per cent total solids; and
(e) may contain sulphurous acid or its salts.
B.18.016 [S]. Glucose or Glucose Syrup
(a) shall be the purified concentrated solution of nutritive saccharides obtained from the incomplete hydrolysis, by means of acid or enzymes, of starch or of a starch-containing substance;
(b) shall have a total solids content of not less than 70 per cent;
(c) shall have a sulphated ash content of not more than 1.0 per cent on a dry basis;
(d) shall have a reducing sugar content (dextrose equivalent) of not less than 20 per cent expressed as D-glucose on a dry basis; and
(e) may contain sulphurous acid or its salts.
B.18.017 [S]. Glucose Solids or Dried Glucose Syrup
(a) shall be glucose or glucose syrup from which the water has been partially removed;
(b) shall have a total solids content of not less than 93 per cent;
(c) shall have a sulphated ash content of not more than 1.0 per cent on a dry basis;
(d) shall have a reducing sugar content (dextrose equivalent) of not less than 20 per cent expressed as D-glucose, on a dry basis; and
(e) may contain sulphurous acid or its salts.
B.18.018 [S]. (Naming the source of the glucose) Syrup
(a) shall be glucose;
(b) may contain
(i) a sweetening agent,
(ii) a flavouring preparation,
(iii) sorbic acid,
(iv) sulphurous acid or its salts,
(v) salt, and
(vi) water; and
(c) shall not contain more than
(i) 35 per cent moisture; and
(ii) 3 per cent ash.
B.18.019 [S]. Lactose
(a) shall be the carbohydrate normally obtained from whey and may
(i) be anhydrous,
(ii) contain one molecule of water of crystalization, or
(iii) be a mixture of both subparagraphs (i) and (ii);
(b) shall not contain less than 99.0 per cent anhydrous lactose on a moisture free basis;
(c) shall not contain more than 0.3 per cent sulphated ash on a moisture free basis;
(d) shall have a weight loss of not more than 6.0 per cent on drying; and
(e) shall have, in a 10 per cent solution, a pH of not less than 4.5 and not more than 7.0.
Honey
B.18.025 [S]. Honey shall be the food produced by honey bees and derived from
(a) the nectar of blossoms,
(b) secretions of living plants, or
(c) secretions on living plants,
and shall have
(d) a fluid, viscous or partly or wholly crystallized consistency;
(e) a diastase activity, determined after processing and blending, as represented by a diastase figure on the Gothe scale of not less than eight where the hydroxy-methyl-furfural content is not more than 0.004 per cent; or
(f) a diastase activity, determined after processing and blending, as represented by a diastase figure on the Gothe scale of not less than three where the hydroxy-methyl-furfural content is not more than 0.0015 per cent.
B.18.026 (1) Subject to subsection (2), honey derived mainly from nectar of blossoms shall not contain
(a) less than 65 per cent apparent reducing sugar, calculated as invert sugar;
(b) more than 20 per cent moisture;
(c) more than 5 per cent apparent sucrose;
(d) more than 0.1 per cent water insoluble solids, except that pressed honey shall contain not more than 0.5 per cent water insoluble solids;
(e) more than 0.6 per cent ash; and
(f) more than 40 milliequivalents acid per 1 000 grams.
(2) Honey derived mainly from the nectar of lavender, rubinia, alfalfa, or banksia menziesii shall meet the requirements of paragraphs (1)(a), (b) and (d) to (f) and shall contain not more than 10 per cent apparent sucrose.
B.18.027 Honey derived from secretions of living plants or from secretions on living plants shall not contain
(a) less than 60 per cent apparent reducing sugar, calculated as invert sugar;
(b) more than 20 per cent moisture;
(c) more than 10 per cent apparent sucrose;
(d) more than 0.1 per cent water insoluble solids, except that pressed honey shall contain not more than 0.5 per cent water insoluble solids;
(e) more than 1.0 per cent ash; and
(f) more than 40 milliequivalents acid per 1 000 grams.
DIVISION 19
Vinegar
B.19.001 Vinegar shall be the liquid obtained by the acetous fermentation of an alcoholic liquid and shall contain not less than 4.1 per cent and not more than 12.3 per cent acetic acid.
B.19.002 The percentage of acetic acid by volume contained in any vinegar described in Division 19 shall be shown on the principal display panel followed by the words “acetic acid”.
B.19.003 [S]. Wine Vinegar shall be vinegar made from wine and may contain caramel.
B.19.004 [S]. Spirit Vinegar, Alcohol Vinegar, White Vinegar or Grain Vinegar shall be vinegar made from diluted distilled alcohol.
B.19.005 [S]. Malt Vinegar shall be vinegar made from an infusion of malt undistilled prior to acetous fermentation, may contain other cereals or caramel, shall be dextro-rotatory, and shall contain, in 100 millilitres measured at a temperature of 20°C, not less than
(a) 1.8 grams of solids, and
(b) 0.2 gram of ash.
B.19.006 [S]. Cider Vinegar or Apple Vinegar shall be vinegar made from the liquid expressed from whole apples, apple parts or apple culls and may contain caramel.
B.19.007 [S]. Blended Vinegar shall be a combination of two or more varieties of vinegar of which spirit vinegar shall contribute not more than 55 per cent of the total acetic acid.
B.19.008 No person shall name any of the varieties of vinegar forming a blended vinegar unless the label of such blended vinegar carries a complete list of all the varieties of vinegar present, in descending order of proportionate content, based on acetic acid.
B.19.009 The maximum limits for the acetic acid content of a vinegar described in section B.19.001 do not apply to vinegar sold only for manufacturing use if the words “For Manufacturing Use Only” are shown on the principal display panel and upon all documents pertaining to such vinegar.
DIVISION 20
Tea
B.20.001 [S]. Tea shall be the dried leaves and buds of Thea sinensis (L.) Sims prepared by the usual trade processes.
B.20.002 [S]. Black Tea shall be black tea or a blend of two or more black teas and shall contain, on the dry basis, not less than 30 per cent water-soluble extractive, as determined by official method FO-37, Determination of Water-Soluble Extractive in Tea, October 15, 1981, and not less than four per cent and not more than seven per cent total ash.
B.20.003 The provisions of B.20.002 do not apply to original unblended black tea that contains, on the dry basis, not less than 25 per cent water-soluble extractive, as determined by official method FO-37, Determination of Water-Soluble Extractive in Tea, October 15, 1981, and not less than four per cent and not more than seven per cent total ash, and is packaged according to good commercial practice in the country of origin.
B.20.004 [S]. Green Tea shall contain, on the dry basis, not less than 33 per cent water-soluble extractive, as determined by official method FO-37, Determination of Water-Soluble Extractive in Tea, October 15, 1981, and not less than four per cent and not more than seven per cent total ash.
B.20.005 [S]. Decaffeinated (indicating the type of tea)
(a) shall be tea of the type indicated, from which caffeine has been removed and that, as a result of the removal, contains not more than 0.4 per cent caffeine; and
(b) may have been decaffeinated by means of extraction solvents set out in Table XV to Division 16.
DIVISION 21
Marine And Fresh Water Animal Products
B.21.001 The foods referred to in this Division are included in the term marine and fresh water animal products.
B.21.002 In this Division,
filler
filler means
(a) flour or meal prepared from grain or potato, but not from a legume,
(b) processed wheat flour containing not less than the equivalent of 80 per cent dextrose, as determined by official method FO-32, Determination of Fillers, Binders and Dextrose Equivalent, October 15, 1981,
(c) bread, biscuit or bakery products, but not those containing or made with a legume,
(d) milk powder, skim milk powder, buttermilk powder or whey powder, and
(e) starch; (remplissage)
marine and fresh water animal
marine and fresh water animal includes
(a) fish,
(b) crustaceans, molluscs, other marine invertebrates,
(c) marine mammals, and
(d) frogs. (animaux marins et animaux d’eau douce)
B.21.003 [S]. Fish shall be the clean, dressed edible portion of fish, with or without salt or seasoning, and may
(a) in the case of frozen fillets, contain ascorbic acid or its sodium salt, citric acid, or erythorbic acid or its sodium salt, and
(i) sodium tripolyphosphate, sodium hexametaphosphate or a combination of sodium tripolyphosphate, sodium acid pyrophosphate and sodium pyrophosphate tetrabasic, or
(ii) a mixture of sodium hexametaphosphate and sodium carbonate;
(b) if frozen, have a glaze consisting of water, acetylated monoglycerides, calcium chloride, sodium alginate, sodium carboxymethyl cellulose, sodium phosphate (dibasic), corn syrup, dextrose, glucose, glucose solids, ascorbic acid or its sodium salt or erythorbic acid or its sodium salt; and
(c) if frozen minced, contain sodium tripolyphosphate, sodium hexametaphosphate, ascorbic acid or its sodium salt, citric acid, erythorbic acid or its sodium salt, or a combination of sodium tripolyphosphate, sodium acid pyrophosphate and sodium pyrophosphate tetrabasic.
B.21.004 [S]. In this Division, meat shall be the clean, dressed flesh of crustaceans, molluscs, other marine invertebrates and marine mammals, whether minced or not, with or without salt or seasoning, and in the case of frozen lobster, frozen crab, frozen shrimp and frozen clams, may contain sodium tripolyphosphate or sodium hexametaphosphate or a combination of sodium 0hexametaphosphate and sodium carbonate or a combination of sodium tripolyphosphate, sodium acid pyrophosphate and sodium pyrophosphate tetrabasic.
B.21.005 Fish, except fish protein, and meat products or preparations thereof are adulterated if any of the following substances or any substance in one of the following classes is present therein or has been added thereto:
(a) mucous membranes, any organ or portion of the genital system, or any organ or portion of a marine or fresh water animal that is not commonly sold as an article of food;
(b) preservatives, other than those provided for in this Division, except
(i) sorbic acid or its salts in dried fish that has been smoked or salted, and in cold processed smoked and salted fish paste, and
(ii) benzoic acid or its salts, methyl-p-hydroxy benzoate and propyl-p-hydroxy benzoate in marinated or similar cold-processed, packaged fish and meat products; and
(c) food colour except as provided for in this Division.
B.21.006 [S]. Prepared fish or prepared meat shall be the whole or comminuted food prepared from fresh or preserved fish or meat respectively, may be canned or cooked, and may,
(a) in the case of lobster paste and fish roe (caviar), contain food colour;
(b) in the case of canned shellfish, canned spring mackerel and frozen cooked shrimp, contain citric acid or lemon juice;
(c) in the case of fish paste, contain filler, fish binder, monoglycerides or mono and diglycerides;
(d) in the case of canned salmon, tuna, lobster, crabmeat and shrimp, contain calcium disodium ethylenediaminetetraacetate (calcium disodium EDTA) and aluminum sulphate;
(e) in the case of canned tuna, contain ascorbic acid;
(f) in the case of canned seafoods, contain sodium acid pyrophosphate, sodium hexametaphosphate or sodium tripolyphosphate, singly, or in combination, at a maximum level of total added phosphate not to exceed 0.5%, calculated as sodium phosphate, dibasic;
(g) contain liquid smoke flavour or liquid smoke flavour concentrate;
(h) contain edible oil, vegetable broth and tomato sauce or puree;
(i) contain a gelling agent if the principal display panel carries the word “jellied” as an integral part of the common name;
(j) contain salt;
(k) in the case of canned snails, canned sea snails and canned clams, contain calcium disodium ethylenediamine tetra-acetate;
(l) in the case of canned flaked tuna, contain sodium sulphite;
(m) in the case of lumpfish caviar, contain tragacanth gum;
(n) in the case of a blend of prepared fish and prepared meat that has the appearance and taste of the flesh of a marine or freshwater animal, contain filler, fish binder, whole egg, egg-white, egg-yolk, food colour, gelling or stabilizing agents, texture-modifying agents, natural and artificial flavouring preparations, pH-adjusting agents, sweetener and, in a proportion not exceeding two per cent of the blend, a legume;
(o) in the case of crustaceans, contain potassium bisulphite, potassium metabisulphite, sodium bisulphite, sodium dithionite, sodium metabisulphite, sodium sulphite or sulphurous acid;
(p) in the case of frozen crustaceans and molluscs, contain calcium oxide and sodium hydroxide;
(q) in the case of frozen pre-cooked battered or breaded fish products, contain citric acid at a level of use not exceeding 0.1 per cent; and
(r) in the case of canned clams, contain sodium erythorbate at a level of use not exceeding 350 parts per million.
B.21.007 [S]. Fish binder for use in or upon prepared fish or prepared meat shall be filler with any combination of salt, sugar, dextrose, glucose, spices and other seasonings.
B.21.008 No person shall sell filler or a fish binder represented for use in fish products either by label or in any advertisement unless the label carries adequate directions for use in accordance with the limits provided in section B.21.020.
B.21.009 Powdered hydrogenated cottonseed oil in an amount not greater than 0.25 per cent of the product may be applied as a release agent to the surface of marine and fresh water animal products.
Prepared Fish
B.21.020 No person shall sell prepared fish or prepared meat that contains more than
(a) that amount of filler, fish binder or other ingredients that is represented by four per cent reducing sugars, calculated as dextrose, as determined by official method FO-32, Determination of Fillers, Binders and Dextrose Equivalent, October 15, 1981; and
(b) 70 per cent moisture where such prepared fish contains filler.
B.21.021 [S]. Preserved fish or preserved meat shall be cooked or uncooked fish or meat that is dried, salted, pickled, cured or smoked and may contain Class I Preservatives, dextrose, glucose, spices, sugar and vinegar, and
(a) dried fish that has been smoked or salted, and cold-processed smoked and salted fish paste may contain sorbic acid or its salts;
(b) smoked fish may contain food colour;
(c) packaged fish and meat products that are marinated or otherwise cold-processed may contain saunderswood (sandalwood), benzoic acid or its salts, methyl-p-hydroxy benzoate and propyl-p-hydroxy benzoate; and
(d) salted anchovy, salted scad and salted shrimp may contain erythrosine in such amount as will result in the finished product containing not more than 125 parts per million of erythrosine.
B.21.022 and B.21.023 [Repealed, SOR/79-252, s. 4]
B.21.024 Notwithstanding section B.21.020 lobster paste shall not contain more than two per cent filler or fish binder.
B.21.025 No person shall sell marine and fresh water animals, or marine and fresh water animal products, that are packed in a container that has been sealed to exclude air and that are smoked or to which liquid smoke flavour or liquid smoke flavour concentrate has been added, unless
(a) the container has been heat-processed after sealing at a temperature and for a time sufficient to destroy all spores of the species Clostridium botulinum;
(b) the contents of the container contain not less than nine per cent salt, as determined by official method FO-38, Determination of Salt in Smoked Fish, dated March 15, 1985;
(c) the contents of the container are customarily cooked before eating; or
(d) the contents of the container are frozen and the principal display panel of the label of the container carries the statement “Keep Frozen Prior to Use” in the same size type used for the common name of the contents of the container.
B.21.027 [S]. Fish Protein
(a) shall be the food prepared by
(i) extracting water, fat and other soluble components through the use of isopropyl alcohol from fresh whole edible fish of the order Clupeiformes, families Clupeidae and Osmeridae and the order Gadiformes, family Gadidae, or from trimmings resulting from the filleting of such fish when eviscerated, and
(ii) drying and grinding the protein concentrate resulting from the operation described in subparagraph (i);
(b) may contain a pH adjusting agent; and
(c) shall not contain
(i) less than 75 per cent protein, which protein shall be at least equivalent to casein in protein quality, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981.
(ii) and (iii) [Repealed, SOR/97-148, s. 8]
Froglegs
B.21.031 No person shall sell fresh or frozen froglegs unless they are free from bacteria of the genus Salmonella, as determined by official method MFO-10, Microbiological Examination of Froglegs, November 30, 1981.
DIVISION 22
Poultry, Poultry Meat, Their Preparations And Products
B.22.001 [S]. Poultry shall be any bird that is commonly used as food.
B.22.002 [S]. Poultry meat shall be the clean, dressed flesh including the heart and gizzard of eviscerated poultry that is healthy at the time of slaughter.
B.22.003 [S]. Poultry meat by-product shall be the clean parts of poultry other than poultry meat commonly used as food and includes liver and skin but excludes the oesophagus, feet and head.
B.22.004 [S]. Giblets shall be the heart, liver and gizzard of poultry.
B.22.005 Poultry meat, poultry meat by-products or preparations thereof are adultered if any of the following substances or any substance in the following classes is present therein or has been added thereto:
(a) any organ or portion of poultry that is not commonly sold as food;
(b) preservatives, other than those provided for in this Division; and
(c) colour, other than caramel.
B.22.006 [S]. Prepared poultry meat or a prepared poultry meat by-product shall be any poultry meat or any poultry meat by-product, respectively, whether comminuted or not, to which has been added any ingredient permitted by these Regulations or that has been preserved, placed in a hermetically-sealed container or cooked, and may contain
(a) where a minimum total protein content or minimum meat protein requirement is prescribed in this Division, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,
(i) sodium acid pyrophosphate,
(ii) sodium hexametaphosphate,
(iii) sodium phosphate, dibasic,
(iv) sodium phosphate, monobasic,
(v) sodium pyrophosphate, tetrabasic,
(vi) sodium tripolyphosphate,
(vii) potassium phosphate, monobasic,
(viii) potassium phosphate, dibasic, and
(ix) potassium pyrophosphate, tetrabasic; and
(b) in the case of dried, cooked poultry meat, a Class IV preservative.
B.22.008 In this Division, filler means any vegetable material (except tomato or beetroot), milk, egg, yeast, or any derivative or combination thereof that is acceptable as food.
B.22.009 No person shall sell
(a) any poultry intended for consumption as food if any preparation having oestrogenic activity has been administered to the poultry; or
(b) poultry meat or poultry meat by-product that contains any residues of exogenous oestrogenic substances.
B.22.010 Powdered hydrogenated cottonseed oil in an amount not greater than 0.25 per cent of the product may be applied as a release agent to the surface of poultry meat, poultry meat by-product, prepared poultry meat, prepared poultry meat by-product, extended poultry product and simulated poultry product.
B.22.011 [S]. Solid cut poultry meat shall be
(a) a whole cut of poultry meat; or
(b) a product consisting of pieces of poultry meat of which at least 80 per cent weigh at least 25 g each.
B.22.012 (1) No person shall sell solid cut poultry meat to which phosphate salts or water has been added unless
(a) that meat
(i) where cooked, contains a meat protein content of not less than 12 per cent, and
(ii) where uncooked, contains a meat protein content of not less than 10 per cent; and
(b) that meat contains, phosphate salts that do not when calculated as sodium phosphate, dibasic, exceed the maximum level provided therefor in Table XII to section B.16.100 and that are one or more of the following phosphate salts, namely,
(i) sodium acid pyrophosphate,
(ii) sodium hexametaphosphate,
(iii) sodium phosphate, dibasic,
(iv) sodium phosphate, monobasic,
(v) sodium pyrophosphate, tetrabasic,
(vi) sodium tripolyphosphate,
(vii) potassium phosphate, monobasic,
(viii) potassium phosphate, dibasic, and
(ix) potassium pyrophosphate, tetrabasic.
(2) A bone or a visible fat layer shall not be included in any calculation used to determine meat protein content for the purposes of paragraph (1)(a).
B.22.013 No person shall sell the whole or any part of a dressed poultry carcass that has been placed in a chilling tank containing fluids to which phosphate salts have been added.
Poultry Meat Stews
B.22.016 For the purposes of sections B.22.017 to B.22.019, stew poultry meat means cooked or uncooked poultry meat containing not more than 15 per cent fat, calculated on the weight of uncooked stew poultry meat.
B.22.017 [S]. Vegetable Stew with (naming the poultry meat)
(a) shall contain vegetables and the named poultry meat in the following amounts:
(i) if uncooked, 12 per cent or more of the named stew poultry meat,
(ii) if cooked, 6 per cent or more of the named stew poultry meat,
(iii) 38 per cent or more vegetables; and
(b) may contain gravy, salt, seasoning and spices.
B.22.018 [S]. (naming the poultry meat) Stew
(a) shall contain vegetables and the named poultry meat in the following amounts:
(i) if uncooked, 20 per cent or more of the named stew poultry meat,
(ii) if cooked, 10 per cent or more of the named stew poultry meat,
(iii) 30 per cent or more vegetables; and
(b) may contain gravy, salt, seasoning and spices.
B.22.019 [S]. Specialty Poultry Meat Stew
(a) shall contain poultry meat and vegetables in the following amounts:
(i) if uncooked, 25 per cent or more of stew poultry meat,
(ii) if cooked, 15 per cent or more of stew poultry meat,
(iii) 30 per cent or more vegetables; and
(b) may contain gravy, salt, seasoning and spices.
Prepared Poultry Meats, Prepared Poultry Meat By-Products
B.22.020 [Repealed, SOR/86-875, s. 7]
B.22.021 [S]. Preserved poultry meat or poultry meat by-product shall be cooked or uncooked poultry meat or poultry meat by-product that is cured or smoked and may contain
(a) Class 1 preservatives;
(b) liquid smoke flavour, liquid smoke flavour concentrate or spices;
(c) sweetening agents;
(d) vinegar; and
(e) in the case of cured poultry or poultry meat prepared by means of injection or cover solution, disodium phosphate, monosodium phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate, in such amount calculated as disodium phosphate, as will result in the finished product containing not more than 0.5 per cent added phosphate.
B.22.022 [S]. Canned (naming the poultry) shall be prepared from poultry meat and may contain
(a) those bones or pieces of bones attached to the portion of the poultry meat that is being canned;
(b) broth;
(c) salt;
(d) seasoning;
(e) gelling agents; and
(f) small amounts of fat.
B.22.023 [S]. Broth that is used in canned (naming the poultry) shall be the liquid in which the poultry meat has been cooked.
B.22.024 Where a gelling agent has been added to canned poultry, a statement to the effect that a gelling agent has been added shall be shown on the principal display panel or the word “jellied” shall be shown as an integral part of the common name of the food.
B.22.025 [S]. Boneless (naming the poultry) shall be canned poultry meat from which the bones and skin have been removed, shall contain not less than 50 per cent of the named poultry meat, as determined by official method FO-39, Determination of Meat in Boneless Poultry, October 15, 1981, and may contain broth having a specific gravity of not less than 1.000 at a temperature of 50°C.
B.22.026 No person shall sell poultry, poultry meat or poultry meat by-product that has been barbecued, roasted or broiled and is ready for consumption unless the cooked poultry, poultry meat or poultry meat by-product
(a) at all times
(i) has a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher, or
(ii) has been stored at an ambient temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher; and
(b) carries on the principal display panel of the label a statement to the effect that the food must be stored at a temperature of 40°F (4.4°C) or lower, or 140°F (60°C) or higher.
Poultry Product Extender
B.22.027 No person shall sell a poultry product extender unless that extender
(a) has, in the rehydrated state,
(i) a total protein content of not less than 16 per cent; and
(ii) a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;
(b) has, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to Division 14 in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and
(c) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.
Extended Poultry Products
B.22.028 No person shall sell a food that consists of a mixture of poultry product and poultry product extender, unless that food
(a) has a total protein content of not less than 16 per cent, and
(b) has a protein rating of not less than 40, as determined by official method, and unless
the poultry product extender meets the requirements of paragraphs B.22.027(a) to (c).
Simulated Poultry Products
B.22.029 No person shall sell a simulated poultry product unless that product
(a) has a total protein content of not less than 16 per cent;
(b) has a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;
(c) has a fat content of not more than 15 per cent;
(d) contains, notwithstanding sections D.01.009 and D.02.009, each vitamin and mineral nutrient listed in Column I of the Table to Division 14 in an amount not less than the amount shown in Column II of that Table opposite each such vitamin and mineral nutrient respectively; and
(e) where isolated essential amino acids have been added, contains those acids in an amount not exceeding an amount that improves the nutritional quality of the protein.
Egg Products
B.22.032 No person shall sell any product simulating whole egg unless that product
(a) is made from liquid, dried or frozen egg albumen or mixtures thereof;
(b) has a protein rating of not less than 40, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981;
(c) notwithstanding sections D.01.009 and D.02.009, contains, per 100 grams on a ready-to-use basis,
(i) not less than
(A) 50 milligrams calcium,
(B) 2.3 milligrams iron,
(C) 1.5 milligrams zinc,
(D) 130 milligrams potassium,
(E) 1000 International Units Vitamin A,
(F) 0.10 milligram thiamine,
(G) 0.30 milligram riboflavin,
(H) 3.60 milligrams niacin,
(I) 1.60 milligrams pantothenic acid,
(J) 0.20 milligram Vitamin B6′,
(K) 0.50 microgram Vitamin B12′,
(L) 0.02 milligram folic acid, and
(M) 2.0 International Units alpha tocopherol, and
(ii) not more than 3 milligrams cholesterol;
(d) has a calcium to phosphorous ratio of not less than one part calcium to four parts phosphorous; and
(e) contains in the total fat of any fat or oil used not less than 40 per cent cis-cis methylene interrupted polyunsaturated fatty acids and not more than 20 per cent saturated fatty acids.
B.22.033 No person shall sell any egg product referred to in sections B.22.032, B.22.034, B.22.035, B.22.036 and B.22.037 for use as food unless it is free from bacteria of the genus Salmonella, as determined by official method MFO-6, Microbiological Examination of Egg Products and Liquid Eggs, November 30, 1981.
B.22.034 [S]. Liquid Whole Egg, Dried Whole Egg or Frozen Whole Egg
(a) shall be the product obtained by removing the shell from wholesome fresh eggs or wholesome stored eggs, and
(i) in the case of dried whole egg, drying the product, or
(ii) in the case of frozen whole egg, freezing the product; and
(b) may
(i) contain aluminum sulphate, pH adjusting agents and the colour beta carotene,
(ii) in the case of liquid whole egg destined for drying, contain yeast autolysate and may be treated with hydrogen peroxide and catalase, glucose oxidase and catalase or yeast and suitable glucose fermenting bacterial culture, or
(iii) in the case of dried whole egg, contain anti-caking agents.
B.22.035 [S]. Liquid Yolk, Dried Yolk or Frozen Yolk
(a) shall be the product obtained by removing the shell and egg-white from wholesome fresh eggs or wholesome stored eggs, and
(i) in the case of dried yolk, drying the product, or
(ii) in the case of frozen yolk, freezing the product, and
(b) may
(i) contain aluminum sulphate, pH adjusting agents and the colour beta carotene,
(ii) in the case of liquid yolk destined for drying, contain yeast autolysate and may be treated with hydrogen peroxide and catalase, glucose oxidase and catalase or yeast and suitable glucose fermenting bacterial culture, or
(iii) in the case of dried yolk, contain anti-caking agents.
B.22.036 [S]. Liquid Egg-White, (Liquid Albumen), Dried Egg-White, (Dried Albumen) or Frozen Egg-White (Frozen Albumen)
(a) shall be the product obtained by removing the shell and yolk from wholesome fresh eggs or wholesome stored eggs, and
(i) in the case of dried egg-white, drying the product, or
(ii) in the case of frozen egg-white, freezing the product; and
(b) may
(i) contain whipping agents, aluminum sulphate and pH adjusting agents,
(ii) in the case of liquid egg-white destined for drying, contain yeast autolysate and may be treated with hydrogen peroxide and catalase, glucose oxidase and catalase or yeast and suitable glucose fermenting bacterial culture,
(iii) in the case of liquid egg-white and dried egg-white, contain lipase or pancreatin, or
(iv) in the case of dried egg-white, contain anti-caking agents.
B.22.037 [S]. Liquid Whole Egg Mix, Dried Whole Egg Mix, Frozen Whole Egg Mix, Liquid Yolk Mix, Dried Yolk Mix or Frozen Yolk Mix
(a) shall be the product obtained by adding salt, sweetening agent or both to Liquid Whole Egg, Dried Whole Egg, Frozen Whole Egg, Liquid Yolk, Dried Yolk or Frozen Yolk; and
(b) may, in the case of dried whole egg mix or dried yolk mix, contain anti-caking agents.
B.22.038 (1) No person shall use a common name referred to in sections B.22.034 to B.22.037 for an egg product that has been subjected to a process, other than a process referred to in those sections, if that process results in a decrease in the amount of a vitamin or mineral nutrient that before processing was present in 100 g of the egg product in an amount equal to at least 10 per cent of the weighted recommended nutrient intake, unless the amount of the vitamin or mineral nutrient is restored to the amount that was present before processing.
(2) Notwithstanding sections D.01.009, D.01.011 and D.02.009, a person may add any vitamin or mineral nutrient referred to in column II of item 27 of the table to section D.03.002 to any egg product referred to in sections B.22.034 to B.22.037 to restore the vitamin or mineral nutrient to the amount that was present in the egg product before processing.
(3) In this section, weighted recommended nutrient intake has the same meaning as in subsection D.01.001(1).
DIVISION 23
Food Packaging Materials
B.23.001 No person shall sell any food in a package that may yield to its contents any substance that may be injurious to the health of a consumer of the food.
B.23.002 Subject to section B.23.003 no person shall sell any food in a package that has been manufactured from a polyvinyl chloride formulation containing an octyltin chemical.
B.23.003 A person may sell food, other than milk, skim milk, partly skimmed milk, sterilized milk, malt beverages and carbonated non-alcoholic beverage products, in a package that has been manufactured from a polyvinyl chloride formulation containing any or all of the octyltin chemicals, namely, di(n-octyl)tin S,S′-bis(isooctylmercaptoacetate), di(n-octyl)tin maleate polymer and (n-octyl)tin S,S′,S″-tris(isooctylmercaptoacetate) if the proportion of such chemicals, either singly or in combination, does not exceed a total of three per cent of the resin, and the food in contact with the package contains not more than one part per million total octyltin.
B.23.004 (1) Di (n-octyl)tin S,S′-bis (isooctylmercaptoacetate) shall be the octyltin chemical made from di (n-octyl)tin dichloride and shall contain 15.1 to 16.4 per cent of tin and 8.1 to 8.9 per cent of mercapto sulfur.
(2) For the purposes of this Division, di (n-octyl)tin dichloride shall be the chemical having an organotin composition of not less than 95 per cent di (n-octyl)tin dichloride and shall contain no more than
(a) five per cent total of n-octyltin trichloride or tri(n-octyl)tin chloride or both;
(b) 0.2 per cent total of other eight (8) carbon isomeric alkyltin derivatives; and
(c) 0.1 per cent total of the higher and lower homologous alkyltin derivatives.
B.23.005 Di(n-octyl)tin maleate polymer shall be the octyltin chemical made from di(n-octyl)tin dichloride and shall have the formula ((C8H17)2 SnC4H2O4)n (where n is between 2 and 4 inclusive), and a saponification number of 225 to 255, and shall contain 25.2 to 26.6 per cent of tin.
B.23.006 (1) (n-octyl)tin S,S′,S″-tris (isooctylmercaptoacetate), being an octyltin chemical having the formula n-C8H17Sn(SCH2CO2C8H17)3, shall be made from (n-octyl)tin trichloride and shall contain 13.4 to 14.8 per cent of tin and 10.9 to 11.9 per cent of mercapto sulfur.
(2) For the purposes of this Division, (n-octyl)tin trichloride shall be the chemical having an organotin composition of not less than 95 per cent (n-octyl)tin trichloride and shall contain not more than
(a) five per cent total of di(n-octyl)tin dichloride, tri(n-octyl)tin chloride or the higher (more than eight (8) carbons) alkyltin chlorides or any combination of the foregoing;
(b) 0.2 per cent total of alkyltin derivatives; and
(c) 0.1 per cent of the lower (less than eight carbons) homologous alkyltin derivatives.
B.23.007 No person shall sell a food in a package than may yield to its contents any amount of vinyl chloride, as determined by official method, FO-40, Determination of Vinyl Chloride in Food, October 15, 1981, in respect of that food.
B.23.008 No person shall sell a food in a package that may yield to its contents any amount of acrylonitrile as determined by official method FO-41, Determination of Acrylonitrile in Food, February 16, 1982, in respect of that food.
Division 24
Foods for Special Dietary Use
B.24.001 In this Division,
expiration date
expiration date means, in respect of a formulated liquid diet, a food represented for use in a very low-energy diet, a meal replacement or a nutritional supplement, the date
(a) after which the manufacturer does not recommend that it be consumed, and
(b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d’utilisation)
food for special dietary use
food for special dietary use means food that has been specially processed or formulated to meet the particular requirements of a person
(a) in whom a physical or physiological condition exists as a result of a disease, disorder or injury, or
(b) for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods; (aliment à usage diététique spécial)
formulated liquid diet
formulated liquid diet means a food that
(a) is sold for consumption in liquid form, and
(b) is sold or represented as a nutritionally complete diet for oral or tube feeding of a person described in paragraph (a) of the definition “food for special dietary use”; (préparation pour régime liquide)
hospital
hospital means a facility
(a) that is licensed, approved or designated as a hospital by a province, in accordance with the laws of the province, to provide care or treatment to persons suffering from any form of disease or illness, or
(b) that is owned or operated by the government of Canada or of a province and that provides health services; (hôpital)
major change
major change means, in respect of a food that is represented for use in a very low energy diet, any change in any of the following, where the manufacturer’s experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, the microbiological or chemical safety of or the safe use of the food:
(a) an ingredient or the amount of an ingredient in the food,
(b) the manufacturing process or the packaging of the food, or
(c) the directions for the preparation and use of the food; (changement majeur)
meal replacement
meal replacement[Repealed, SOR/95-474, s. 3]
pharmacist
pharmacist means a person who is registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy under those laws in that province; (pharmacien)
physician
physician means a person who is registered and entitled under the laws of a province to practise medicine and who is practicing medicine under those laws in that province; (médecin)
prepackaged meal
prepackaged meal[Repealed, SOR/95-474, s. 3]
target body weight
target body weight means the anticipated body weight at the end of the weight reduction diet, as determined by the physician before the weight reduction diet begins; (poids corporel cible)
very low energy diet
very low energy diet means a diet for weight reduction that provides less than 900 kilocalories per day when followed as directed. (régime à très faible teneur en énergie)
B.24.003 (1) No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use unless the food is
(a) to (e) [Repealed, SOR/2003-11, s. 21]
(f) a formulated liquid diet that meets the requirements contained in sections B.24.101 and B.24.102;
(f.1) a meal replacement for special dietary use that meets the requirements contained in section B.24.200;
(f.2) a nutritional supplement that meets the requirements contained in section B.24.201;
(g) a gluten-free food that meets the requirements contained in section B.24.018;
(h) represented for protein-restricted diets;
(i) represented for low (naming the amino acid) diets; or
(j) a food represented for use in a very low energy diet, where the food meets the requirements contained in section B.24.303.
(1.1) Despite subsection (1), a person may label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use if its label carries a statement or claim set out in column 4 of the table following section B.01.513, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1:
(a) “free of energy”, set out in item 1;
(b) “low in energy”, set out in item 2;
(c) “free of sodium or salt”, set out in item 31;
(d) “low in sodium or salt”, set out in item 32; or
(e) “free of sugars”, set out in item 37.
(2) Subsection (1) does not apply to infant formulas.
(3) No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is for use in a weight reduction diet unless that food is
(a) a meal replacement that meets the compositional requirements contained in section B.24.200;
(b) a prepackaged meal;
(c) a food sold by a weight reduction clinic to clients of the clinic for use in a weight reduction program supervised by the staff of the clinic; or
(d) a food represented for use in a very low-energy diet that meets the compositional requirements contained in section B.24.303.
(4) Except as otherwise permitted by these Regulations, no person shall label, package, sell or advertise a food as “dietetic” or “diet”, or use those words as part of the brand name of the food, unless its label carries a statement or claim set out in column 4 of the table following section B.01.513, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1:
(a) “free of energy”, set out in item 1;
(b) “low in energy”, set out in item 2;
(c) “reduced in energy”, set out in item 3;
(d) “lower in energy”, set out in item 4; or
(e) “free of sugars”, set out in item 37.
B.24.004 to B.24.014 [Repealed, SOR/2003-11, s. 22]
B.24.015 and B.24.016 [Repealed, SOR/88-559, s. 6]
B.24.017 (1) Where the manufacturer of a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet is requested in writing by the Director to submit, on or before a specified day, evidence with respect to that product, the manufacturer shall make no further sales of that product after that day unless the manufacturer has submitted the evidence requested.
(2) Where the Director is of the opinion that the evidence submitted by a manufacturer pursuant to subsection (1) is not sufficient, he shall so notify the manufacturer in writing.
(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet is not sufficient, the manufacturer shall make no further sales of that product unless the manufacturer submits further evidence and is notified in writing by the Director that the further evidence is sufficient.
(4) A reference in this section to evidence with respect to a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet means evidence to establish that the food is nutritionally adequate to be used as the sole source of nutrition in meeting the nutritional needs of a person for whom it is intended, when the food is consumed in accordance with the directions for use.
B.24.018 No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food unless the food does not contain wheat, including spelt and kamut, or oats, barley, rye or triticale or any part thereof.
B.24.019 [Repealed, SOR/2003-11, s. 23]
Formulated Liquid Diets
B.24.100 No person shall advertise a formulated liquid diet to the general public.
B.24.101 No person shall sell a formulated liquid diet unless the food
(a) if sold ready to serve, or
(b) if not sold ready to serve, when diluted with water, milk, or water and milk,
is a complete substitute for the total diet in meeting the nutritional requirements of a person.
B.24.102 (1) Subject to subsection (4), a formulated liquid diet shall contain, when ready to serve,
(a) either
(i) not less than 20 grams of protein of nutritional quality equivalent to casein, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981, or
(ii) such an amount and quality of protein, including those proteins to which amino acids are added, that, when the quality of the protein is expressed as a fraction of the quality of casein,
(A) the fraction will not be less than 85/100, and
(B) the result obtained by multiplying the fraction by the gram weight of the protein will not be less than 20; and
(b) not less than one gram linoleic acid in the form of a glyceride.
(2) Notwithstanding sections D.01.009, D.01.011 and D.02.009, a formulated liquid diet shall contain, when ready to serve, the vitamins and minerals named in Column I of the table to this section in amounts,
(a) where the recommended intake of the food is 2,500 kilocalories per day or less, not less than the amounts set out in Column II and not more than the amounts, if any, set out in Column III of that table opposite those vitamins and minerals; and
(b) where the recommended intake of the food is greater than 2,500 kilocalories per day, not less than the amounts set out in Column IV and not more than the amounts, if any, set out in Column V of the table opposite those vitamins and minerals.
(3) The amounts of the nutrients specified in paragraphs (1)(a) and (b) and subsection (2) shall be calculated
(a) per 1,000 available kilocalories, where the recommended intake of the food is 2,500 kilocalories per day or less; and
(b) per 1,500 available kilocalories, where recommended intake of the food is greater than 2,500 kilocalories per day.
(4) Paragraph (1)(a) does not apply to a formulated liquid diet represented as being for a protein restricted diet or a low (named amino acid) diet.
TABLE
Column IPer 1,000 available kilocaloriesPer 1,500 available kilocaloriesColumn IIColumn IIIColumn IVColumn VVitaminsMinimumMaximumMinimumMaximumVitamin A2,000 International Units5,000 International Units2,000 International Units3,000 International UnitsVitamin D100 International Units400 International Units100 International Units200 International UnitsVitamin E (a-tocopherol)5.0 International Units5.0 International UnitsAscorbic Acid20 milligrams20 milligramsThiamine0.5 milligram0.6 milligramRiboflavin0.7 milligram0.84 milligramNiacin6.6 milligrams7.9 milligramsVitamin B60.9 milligram0.9 milligramVitamin B121.5 micrograms1.5 microgramsFolic Acid100 micrograms100 microgramsd-pantothenic Acid2.5 milligrams2.5 milligramsMineral NutrientsCalcium400 milligrams400 milligramsPhosphorus400 milligrams400 milligramsIron8 milligrams8 milligramsIodine50 micrograms50 microgramsMagnesium150 milligrams150 milligramsCopper1 milligram1 milligramZinc7 milligrams7 milligramsB.24.103 The label of a formulated liquid diet shall carry the following information:
(a) a statement that the food is intended to be consumed orally or by tube feeding;
(b) a statement of the energy value of the food, expressed in Calories
(i) per 100 grams or per 100 millilitres of the food as offered for sale, and
(ii) per unit of ready-to-serve food;
(c) a statement of the content in the food of protein or protein equivalent, fat, linoleic acid, available carbohydrate and, where present, crude fibre, expressed in grams
(i) per 100 grams or per 100 millilitres of the food as offered for sale, and
(ii) per unit of ready-to-serve food;
(d) a statement of the content of vitamins and mineral nutrients that are listed in the table to section B.24.102, expressed in International Units or milligrams
(i) per 100 grams or per 100 millilitres of the food as offered for sale, and
(ii) per unit of ready-to-serve food;
(e) a statement of the content of any vitamin or mineral nutrient that is not listed in the table to section B.24.102, expressed in milligrams
(i) per 100 grams or per 100 millilitres of the food as offered for sale, and
(ii) per unit of ready-to-serve food;
(f) complete directions for the preparation and use of the food and for its storage after the container has been opened; and
(g) the expiration date of the formulated liquid diet.
Meal Replacements, Nutritional Supplements, Prepackaged Meals and Foods Sold by Weight Reduction Clinics
B.24.200 (1) No person shall sell or advertise a meal replacement unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk or skim milk, or a combination thereof, it meets the following requirements:
(a) the meal replacement provides a minimum of 225 kcal or 945 kJ per serving;
(b) not less than 15 per cent and not more than 40 per cent of the energy available from the meal replacement is derived from its protein content, except that a meal replacement for use in a weight reduction diet shall derive not less than 20 per cent of its available energy from its protein content;
(c) subject to subsection (2), not more than 35 per cent of the energy available from the meal replacement is derived from its fat content;
(d) not less than 3.0 per cent of the energy available from the meal replacement is derived from linoleic acid in the form of a glyceride and not less than 0.5 per cent of the energy available from the meal replacement is derived from n-3 linolenic acid in the form of a glyceride, and the ratio of linoleic acid to n-3 linolenic acid is not less than 4 to 1 and not more than 10 to 1;
(e) the proteins present in the meal replacement are
(i) of a nutritional quality equivalent to that of casein, or
(ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent, or not less than 20 per cent in the case of a meal replacement for use in a weight reduction diet, when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the meal replacement; and
(f) each serving of the meal replacement contains each vitamin and mineral nutrient listed in column I of the table to this section
(i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and
(ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.
(2) No person shall sell or advertise a meal replacement that is represented as a replacement for all daily meals unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk or skim milk, or a combination thereof, it meets the following requirements:
(a) not more than 30 per cent of the energy available from the meal replacement is derived from its fat content; and
(b) not more than 10 per cent of the energy available from the meal replacement is derived from its saturated fatty acid content.
(3) The minimum amount required under subparagraph (1)(f)(i) for selenium, chromium or molybdenum does not apply in respect of a meal replacement that is not represented as a replacement for all daily meals and that does not contain added selenium, chromium or molybdenum, as the case may be.
(4) A vitamin or mineral nutrient that is not an added ingredient in the meal replacement shall not be taken into account for the purposes of subparagraph (1)(f)(ii).
(5) The maximum amount shown for vitamin C in column III of the table to this section does not include overage.
TABLE
Column IColumn IIColumn IIINutrientsMinimum Amount per ServingMaximum Amount per ServingVITAMINSVitamin A250 RE630 REVitamin D1.25 µg2.50 µgVitamin E2.5 mg5.0 mgVitamin C10 mg20 mgThiamine300 µg750 µgRiboflavin400 µg800 µgNiacin6 NE12 NEVitamin B6400 µg750 µgVitamin B120.25 µg0.75 µgFolacin60 µg120 µgPantothenic acid1.25 mg2.50 mgBiotin25 µg75 µgMINERAL NUTRIENTSCalcium200 mg400 mgPhosphorus250 mg500 mgIron2.5 mg5.0 mgIodide40 µg120 µgMagnesium60 mg120 mgCopper0.5 mg1.0 mgZinc3 mg6 mgPotassium375 mgSodium250 mgManganese1 mg2 mgSelenium10 µg20 µgChromium10 µg20 µgMolybdenum20 µg40 µgB.24.201 (1) No person shall sell or advertise a nutritional supplement that contains less than 225 kcal or 945 kJ per serving, unless it meets the following requirements:
(a) the nutritional supplement contains at least 150 kcal or 630 kJ per serving;
(b) not less than 15 per cent and no more than 40 per cent of the energy available from the nutritional supplement is derived from its protein content;
(c) the proteins present in the nutritional supplement are
(i) of a nutritional quality equivalent to that of casein, or
(ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the nutritional supplement; and
(d) the nutritional supplement contains, per 100 kcal or 420 kJ, each vitamin and mineral nutrient listed in column I of the table to this section
(i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and
(ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.
(2) No person shall sell or advertise a nutritional supplement that provides 225 kcal or 945 kJ, or more, per serving unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk, skim milk, or a combination thereof, it meets the following requirements:
(a) the nutritional supplement provides at least 225 kcal or 945 kJ per serving;
(b) not more than 35 per cent of the energy available from the nutritional supplement is derived from its fat content;
(c) not less than 3.0 per cent of the energy available from the nutritional supplement is derived from linoleic acid in the form of a glyceride and not less than 0.5 per cent of the energy available from the nutritional supplement is derived from n-3 linolenic acid in the form of a glyceride, and the ratio of linoleic acid to n-3 linolenic acid is not less than 4 to 1 and not more than 10 to 1;
(d) not less than 15 per cent and not more than 40 per cent of the energy available from the nutritional supplement is derived from its protein content;
(e) the proteins present in the nutritional supplement are
(i) of a nutritional quality equivalent to that of casein, or
(ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the nutritional supplement; and
(f) the nutritional supplement contains, per 100 kcal or 420 kJ, each vitamin and mineral nutrient listed in column I of the table to this section
(i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and
(ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.
(3) The minimum amount required under subparagraph (1)(d)(i) or (2)(f)(i) for selenium, chromium or molybdenum does not apply in respect of a nutritional supplement that does not contain added selenium, chromium or molybdenum, as the case may be.
(4) A vitamin or mineral nutrient that is not an added ingredient in the nutritional supplement shall not be taken into account for the purposes of subparagraphs (1)(d)(ii) and (2)(f)(ii).
(5) The maximum amount shown for vitamin C in column III of the table to this section does not include overage.
TABLE
Column IColumn IIColumn IIINutrientsMinimum Amount per Available 100 Kcal or 420 KJMaximum Amount per Available 100 Kcal or 420 KJVITAMINSVitamin A100 RE250 REVitamin D0.25 µg1 µgVitamin E1.0 mg2.0 mgVitamin C5 mg10 mgThiamine140 µg350 µgRiboflavin180 µg360 µgNiacin3 NE6 NEVitamin B6180 µg350 µgVitamin B120.1 µg0.3 µgFolacin30 µg60 µgPantothenic acid0.6 mg1.2 mgBiotin12 µg35 µgMINERAL NUTRIENTSCalcium100 mg175 mgPhosphorus100 mg175 mgIron1.0 mg2.0 mgIodide15 µg45 µgMagnesium20 mg40 mgCopper0.15 mg0.30 mgZinc1.4 mg2.0 mgPotassium175 mgManganese0.45 mg0.90 mgSelenium4 µg8 µgChromium4 µg8 µgMolybdenum8 µg15 µgB.24.202 The label of a meal replacement or nutritional supplement shall
(a) show the following information per serving of stated size and per stated quantity of food, when prepared according to the directions for use:
(i) the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ),
(ii) the protein, fat, linoleic acid, n-3 linolenic acid, saturated fatty acid and carbohydrate contents of the food, expressed in grams,
(iii) the vitamin A, vitamin D, vitamin E, vitamin C, thiamin or vitamin B1, riboflavin or vitamin B2, niacin, vitamin B6, vitamin B12, folacin and pantothenic acid or pantothenate contents of the food, expressed, in the case of a meal replacement, as a percentage of the recommended daily intake specified in column II of the table to Division 1 of Part D for that vitamin and, in the case of a nutritional supplement, in retinol equivalents (RE) for vitamin A, in niacin equivalents (NE) for niacin and in milligrams for vitamin D, vitamin E, vitamin C, thiamin or vitamin B1, riboflavin or vitamin B2, vitamin B6, vitamin B12, folacin and pantothenic acid or pantothenate,
(iv) the calcium, phosphorus, iron, iodide, magnesium and zinc contents of the food, expressed, in the case of a meal replacement, as a percentage of the recommended daily intake specified for that mineral nutrient in column II of the table to Division 2 of Part D and, in the case of a nutritional supplement, expressed in milligrams, and
(v) the biotin, copper, potassium, sodium, manganese, selenium, chromium and molybdenum contents of the food, expressed in milligrams;
(b) in the case of a meal replacement or a nutritional supplement to which milk, partially skim milk or skim milk is to be added, carry a statement that the nutrient content of the food has been determined taking into consideration the milk, partially skim milk or skim milk that will be added according to the directions for use;
(c) in the case of a meal replacement that is sold or advertised as a replacement for all daily meals in a weight reduction diet, include directions for use that would result in a daily energy intake of at least 900 kcal or 3 780 kJ;
(d) include the expiration date of the meal replacement or nutritional supplement;
(e) in the case of a meal replacement for use in a weight reduction diet, carry the statement “USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET / UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE” prominently displayed on the principal display panel; and
(f) in the case of a meal replacement for use in a weight reduction diet that is not represented as a replacement for all daily meals in a diet, include the information required under section B.24.204.
B.24.203 The label of a prepackaged meal for use in a weight reduction diet or of a food to be sold in a weight reduction clinic shall
(a) [Repealed, SOR/2003-11, s. 24]
(b) carry the statement “USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET / UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE” prominently displayed on the principal display panel; and
(c) include the information required under section B.24.204.
B.24.204 The label of a prepackaged meal, or of a meal replacement other than a meal replacement represented as a replacement for all daily meals in a diet, that is packaged, sold or advertised for use in a weight reduction diet, or of a food to be sold in a weight reduction clinic, shall include, in the directions for use, a sample seven-day menu in which the prepackaged meal, meal replacement or food is used and which meets the following requirements:
(a) each daily meal includes a minimum of one serving, as described in Canada’s Food Guide to Healthy Eating, published in 1992 by the Department of Supply and Services by authority of the Minister of National Health and Welfare, of one food from each of the following groups:
(i) milk, milk products or their alternatives,
(ii) meat and meat alternatives,
(iii) bread and grain products, and
(iv) vegetables and fruit;
(b) the daily energy intake provided for is not less than 1 200 kcal or 5 040 kJ;
(c) not more than 30 per cent of the total daily energy intake of the seven-day menu is derived from its fat content and not more than 10 per cent of the total daily energy intake of the menu is derived from its saturated fatty acid content;
(d) the mean daily intake of each nutrient listed in column I of the table to this section is not less than the amount shown in column II, in the case of a menu recommended for men, or in column III, in the case of a menu recommended for women; and
(e) the menu does not include any reference to vitamin or mineral supplements.
TABLE
Column IColumn IIColumn IIINutrientsMean Daily IntakeMenWomenProtein65 g55 gVITAMINSVitamin A1000 RE800 REVitamin D5 µg5 µgVitamin E10 mg7 mgVitamin C40 mg30 mgThiamin1 mg1 mgRiboflavin1 mg1 mgNiacin14 NE14 NEVitamin B61.5 mg1.5 mgVitamin B121 µg1 µgFolacin230 µg200 µgPantothenic Acid5 mg5 mgMINERAL NUTRIENTSCalcium800 mg800 mgPhosphorus1000 mg850 mgIron9 mg13 mgIodide160 µg160 µgMagnesium250 mg210 mgCopper2 mg2 mgZinc12 mg9 mgB.24.205 (1) No person shall label, package, sell or advertise a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, in a manner likely to create an impression that consumption of a vitamin or mineral supplement must be part of a weight reduction diet.
(2) No person shall, on a label of or in an advertisement for a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, make any direct or indirect reference to a vitamin or mineral supplement.
(3) Every person who advertises a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, shall include in the advertisement the statement “USEFUL IN WEIGHT REDUCTION ONLY AS PART OF AN ENERGY-REDUCED DIET / UTILE POUR PERDRE DU POIDS SEULEMENT DANS LE CADRE D’UN RÉGIME À TENEUR RÉDUITE EN ÉNERGIE”.
Foods Represented for Use in Very Low Energy Diets
B.24.300 No person shall advertise to the general public a food represented for use in a very low energy diet.
B.24.301 (1) No person shall sell, without a written order from a physician, a food represented for use in a very low energy diet.
(2) Notwithstanding subsection (1), a person may sell, without a written order from a physician, a food represented for use in a very low energy diet to
(a) a physician;
(b) a wholesale druggist;
(c) a pharmacist; or
(d) a hospital.
(3) No person other than a pharmacist shall sell to the general public a food represented for use in a very low energy diet.
B.24.302 A pharmacist shall retain the written order of a physician for a food represented for use in a very low energy diet for at least two years after the date on which the order is filled.
B.24.303 (1) A food represented for use in a very low energy diet, whether ready to serve or diluted with water according to the manufacturer’s directions, shall provide, per daily allowance recommended by the manufacturer
(a) either
(i) not less than 60 g of protein of a nutritional quality equivalent to that of casein, or
(ii) such an amount and quality of protein that, when the quality of the protein is expressed as a fraction of the quality of casein,
(A) the fraction is not less than 85/100, and
(B) the product obtained by multiplying the fraction by the gram weight of the protein is not less than 60;
(b) each vitamin or mineral nutrient named in column I of an item of the table to this subsection, in an amount not less than the minimum amount per day set out in column II of that item; and
(c) any nutritive substance added to the food other than those referred to in paragraph (a) or (b), in an amount that is appropriate for the purpose of the substance in the food as determined from clinical trials.
TABLE
Column IColumn IIItemVitamin or Mineral NutrientMinimum amount per day1Thiamine1.3 mg2Riboflavin1.6 mg3Niacin23 mg4Folacin0.22 mg5Biotin0.15 mg6Pantothenic acid7.0 mg7Vitamin B61.5 mg8Vitamin B120.001 mg9Vitamin A1000 RE10Vitamin D0.005 mg11Vitamin E10 mg12Vitamin C40 mg13Calcium800 mg14Phosphorus1000 mg15Magnesium250 mg16Iron13 mg17Iodine0.16 mg18Zinc12 mg19Copper2 mg20Manganese3.5 mg21Selenium0.07 mg22Chromium0.05 mg23Molybdenum0.1 mg24Sodium2000 mg25Potassium3000 mg26Chloride1500 mg(2) Notwithstanding paragraph (1)(a), a food represented for use in a very low energy diet shall be accompanied by directions for use that when followed would result in the daily intake by a person of at least 1.2 g of protein per kilogram target body weight.
B.24.304 The label of a food represented for use in a very low energy diet shall carry the following information:
(a) a statement of the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ) per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;
(b) a statement of the content in the food of protein, fat, carbohydrate and, where present, fibre expressed in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;
(c) a statement of the content in the food of all those vitamins and mineral nutrients that are listed in the table to subsection B.24.303(1) expressed in milligrams, in the case of vitamin A expressed in retinol equivalents (RE), per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;
(d) a statement of the content in the food of any other nutritive substance added to the food in an amount described in paragraph B.24.303(1)(c), expressed in milligrams or in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;
(e) the statement “USE ONLY UNDER MEDICAL SUPERVISION” prominently displayed on the principal display panel;
(f) directions for use of the food, including
(i) a statement of the rationale for the use of the food,
(ii) criteria to be used for the selection of the persons to whom the food may be prescribed,
(iii) instructions for consultation with and evaluation of the patient and patient follow-up, and
(iv) a statement concerning adequate precautions and contra-indications;
(g) directions for the preparation of the food, and storage instructions for the food before and after the container has been opened; and
(h) the expiration date of the food.
B.24.305 (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell the food or advertise the food for sale.
(2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a low energy diet, the following information:
(a) the name under which the food is to be sold or advertised for sale;
(b) the name and address of the principal place of business of the manufacturer;
(c) the name and address of each establishment in which the food is manufactured;
(d) a list of the ingredients of the food, stated quantitatively;
(e) the specifications for nutrient, microbiological and physical quality for each ingredient and for the food;
(f) details of quality control procedures respecting the testing of the ingredients and of the food;
(g) details of the manufacturing process and quality control procedures used throughout the process;
(h) the results of tests carried out to determine the expiration date of the food;
(i) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use;
(j) a description of the type of packaging to be used;
(k) directions for use;
(l) the written text of all labels, including package inserts, to be used in connection with the food; and
(m) the name and title of the person who signed the notification and the date of signature.
(3) Notwithstanding subsection (1), a person may sell or advertise for sale a food represented for use in a very low energy diet, if the Director, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2).
B.24.306 (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change, unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the food that has undergone the major change.
(2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a very low energy diet that has undergone a major change, the following information:
(a) the name under which the food is to be sold or advertised for sale;
(b) the name and address of the principal place of business of the manufacturer;
(c) a description of the major change;
(d) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use;
(e) the evidence relied on to establish that the major change has no adverse effect on the food or its use;
(f) the written text of all labels, including package inserts, to be used in connection with the food; and
(g) the name and title of the person who signed the notification and the date of signature.
(3) Notwithstanding subsection (1), a person may sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change, if the Director, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2).
Division 25
Interpretation
B.25.001 In this Division,
expiration date
expiration date means, in respect of a human milk substitute, the date
(a) after which the manufacturer does not recommend that it be consumed, and
(b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d’utilisation)
human milk substitute
human milk substitute means any food that is represented
(a) for use as a partial or total replacement for human milk and intended for consumption by infants, or
(b) for use as an ingredient in a food referred to in paragraph (a); (succédané de lait humain)
infant
infant means a person who is under the age of one year; (bébé)
infant food
infant food means a food that is represented for consumption by infants; (aliment pour bébés)
junior (naming a food)
junior (naming a food) means the named food where it contains particles of a size to encourage chewing by infants, but may be readily swallowed by infants without chewing; ((nom d’un aliment) pour enfants en bas âge)
major change
major change means, in respect of a human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the human milk substitute where the manufacturer’s experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, or the microbiological or chemical safety of, the human milk substitute; (changement majeur)
new human milk substitute
new human milk substitute means a human milk substitute that is
(a) manufactured for the first time,
(b) sold in Canada for the first time, or
(c) manufactured by a person who manufactures it for the first time; (succédané de lait humain nouveau)
strained (naming a food)
strained (naming a food) means the named food where it is of a generally uniform particle size that does not require and does not encourage chewing by infants before being swallowed. ((nom d’un aliment) en purée ou tamisé)
Infant Foods
B.25.002 No person shall sell or advertise for sale an infant food that is set out in Column I of an item of Table I to this Division and contains more than the amount of sodium set out in Column II of that item.
B.25.003 (1) Subject to subsection (2), no person shall sell infant food that contains
(a) strained fruit,
(b) fruit juice,
(c) fruit drink, or
(d) cereal,
if sodium chloride has been added to that food.
(2) Subsection (1) does not apply to strained desserts containing any of the foods mentioned in paragraphs (1)(a) to (d).
Human Milk Substitutes and Food Containing Human Milk Substitutes
B.25.045 The common name of a human milk substitute or a new human milk substitute shall be infant formula. (préparation pour nourrissons)
B.25.046 (1) No person shall sell or advertise for sale a new human milk substitute unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the new human milk substitute.
(2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the new human milk substitute, the following information:
(a) the name under which it will be sold or advertised for sale;
(b) the name and the address of the principal place of business of the manufacturer;
(c) the names and addresses of each establishment in which it is manufactured;
(d) a list of all of its ingredients, stated quantitatively;
(e) the specifications for nutrient, microbiological and physical quality for the ingredients and for the new human milk substitute;
(f) details of quality control procedures respecting the testing of the ingredients and of the new human milk substitute;
(g) details of the manufacturing process and quality control procedures used throughout the process;
(h) the results of tests carried out to determine the expiration date of the new human milk substitute;
(i) the evidence relied on to establish that the new human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use;
(j) a description of the type of packaging to be used;
(k) directions for use;
(l) the written text of all labels, including package inserts, to be used in connection with the new human milk substitute; and
(m) the name and title of the person who signed the notification and the date of signature.
(3) Notwithstanding subsection (1), a person may sell or advertise for sale a new human milk substitute if the manufacturer has notified the Director pursuant to subsection (1) and is informed in writing by the Director that the notification is satisfactory.
B.25.047 Sections B.25.051 to B.25.059 apply in respect of new human milk substitutes.
B.25.048 (1) No person shall sell or advertise for sale a human milk substitute that has undergone a major change unless the manufacturer of the human milk substitute, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the human milk substitute.
(2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the human milk substitute, the following information:
(a) the name under which it will be sold or advertised for sale;
(b) the name and the address of the principal place of business of the manufacturer;
(c) a description of the major change;
(d) the evidence relied on to establish that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use;
(e) the evidence relied on to establish that the major change has had no adverse effect on the human milk substitute;
(f) the written text of all labels, including package inserts, to be used in connection with the human milk substitute; and
(g) the name and title of the person who signed the notification and the date of signature.
(3) Notwithstanding subsection (1), a person may sell or advertise for sale a human milk substitute that has undergone a major change if the manufacturer has notified the Director pursuant to subsection (1) and is informed in writing by the Director that the notification is satisfactory.
B.25.050 [Repealed, SOR/90-174, s. 2]
B.25.051 (1) No person shall sell or advertise for sale a human milk substitute unless, when prepared according to directions for use, it complies with the provisions of this Division respecting human milk substitutes.
(2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with the nutritional requirements set out in this Division for human milk substitutes.
B.25.052 (1) No person shall sell or advertise for sale a human milk substitute unless it meets the nutritional requirements of infants with normal or special dietary needs and it is of such a consistency that, when ready-to-serve, it passes freely through a nursing bottle nipple.
(2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food meets the nutritional requirements of infants with normal or special dietary needs.
B.25.053 (1) No person shall sell or advertise for sale a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance, other than water or a source of carbohydrate or both.
(2) No person shall sell or advertise for sale a food represented as containing a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance other than water.
B.25.054 (1) Except as otherwise provided in this Division, no person shall sell or advertise for sale a human milk substitute unless it contains, when prepared according to directions for use,
(a) per 100 available kilocalories
(i) not less than 3.3 and not more than 6.0 grams of fat,
(ii) not less than 500 milligrams of linoleic acid in the form of a glyceride,
(iii) not more than 1 kilocalorie from C22 Monoenoic Fatty Acids,
(iv) not less than 1.8 and not more than 4.0 grams of protein,
(v) not less than 1.8 grams of protein of nutritional quality equivalent to casein, or such an amount and quality of protein, including those proteins to which amino acids are added, that, when the quality of the protein is expressed as a fraction of the quality of casein,
(A) the fraction will not be less than 85/100, and
(B) the product obtained by multiplying the fraction by the gram weight of the protein will not be less than 1.8,
(vi) notwithstanding sections D.01.010, D.01.011 and D.02.009, the vitamin and mineral nutrient set out in Column I of an item of Table II to this Division in an amount not less than the amount set out in Column II of that item and not more than the amount set out in Column III of that item, and
(vii) not less than 12 milligrams of choline; and
(b) a ratio of
(i) alpha-tocopherol to linoleic acid of not less than 0.6 International Units to one gram,
(ii) calcium to phosphorus of not less than 1.2 grams to one gram and not more than 2.0 grams to one gram, and
(iii) vitamin B6 to protein of not less than 15 micrograms to one gram.
(2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with subsection (1).
B.25.055 (1) Subparagraph B.25.054(1)(a)(i) does not apply to a human milk substitute represented as being for a fat-modified diet.
(2) Subparagraph B.25.054(1)(a)(iv), except that portion thereof that prescribes the maximum amount of protein, and subparagraph B.25.054(1)(a)(v) do not apply to a human milk substitute represented as being for a low (naming the amino acid) diet.
(3) All that portion of subparagraph B.25.054(1)(a)(vi) that prescribes the minimum amounts of vitamin D, calcium and phosphorus and subparagraph B.25.054(1)(b)(ii) do not apply to a human milk substitute represented as being for a low (naming the mineral) diet or a low vitamin D diet or both.
B.25.056 No person shall sell a human milk substitute or a food that is represented as containing a human milk substitute
(a) that contains an added nutritive substance that is
(i) normally contained in human milk, and
(ii) not referred to in paragraph B.25.054(1)(a)
unless the amount of that substance present per 100 available kilocalories of the human milk substitute or human milk substitute portion of the food, when prepared according to directions for use, is equal to the amount thereof present per 100 available kilocalories of human milk; or
(b) that contains added amino acids unless
(i) the amino acids are required to improve the quality of the protein in the human milk substitute or human milk substitute portion of the food and are present in an amount not exceeding the minimum required for that purpose, or
(ii) the protein content of the human milk substitute or human milk substitute portion of the food is supplied by isolated amino acids or by protein hydrolysate, or both
and only the L forms of the amino acids have been added.
B.25.057 (1) The label of a human milk substitute shall carry the following information:
(a) a statement of the content of protein, fat, available carbohydrate, ash and, where present, crude fibre in the food
(i) in grams per 100 grams or in grams per 100 millilitres of the human milk substitute as offered for sale, and
(ii) in grams in a stated quantity of the human milk substitute when ready-to-serve;
(b) a statement of the energy value expressed in
(i) calories per 100 grams or calories per 100 millilitres of the human milk substitute as offered for sale, and
(ii) calories in a stated quantity of the human milk substitute when ready-to-serve;
(c) a statement of the quantity of all vitamins and mineral nutrients listed in Table II to this Division
(i) in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the human milk substitute as offered for sale, and
(ii) in International Units or milligrams in a stated quantity of the human milk substitute when ready-to-serve;
(d) a statement of the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a)
(i) in milligrams or grams per 100 grams, or in milligrams or grams per 100 millilitres, of the human milk substitute as offered for sale, and
(ii) in milligrams or grams in a stated quantity of the human milk substitute when ready-to-serve;
(e) adequate directions for the preparation, use and storage of the human milk substitute after the container has been opened; and
(f) the expiration date of the human milk substitute.
(2) The label of a food that is represented as containing human milk substitute shall carry the following information:
(a) a statement on the principal display panel of the proportion of the human milk substitute contained in the food as offered for sale in close proximity to any claim regarding the presence of the human milk substitute and given equal prominence to such a claim;
(b) the common name of the human milk substitute in the list of ingredients to be followed by a statement of all the components contained in the human milk substitute;
(c) a statement of
(i) the content of protein, fat, available carbohydrate, ash and, where present, crude fibre contained in the human milk substitute portion of the food, expressed in grams per 100 grams or per 100 millilitres of the human milk substitute portion of the food as offered for sale,
(ii) the energy value of the human milk substitute portion of the food expressed in calories per 100 grams or in calories per 100 millilitres of the human milk substitute portion of the food as offered for sale,
(iii) the quantity of all the vitamins and mineral nutrients set out in Table II to this Division that are contained in the human milk substitute portion of the food in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the human milk substitute portion of the food as offered for sale, and
(iv) the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) contained in the human milk substitute portion of the food in milligrams or grams per 100 grams or in milligrams or grams per 100 millilitres of the human milk substitute portion of the food as offered for sale;
(d) a statement of
(i) the content of protein, fat, available carbohydrate, ash and, where present, crude fibre in grams per 100 grams or per 100 millilitres of the food as offered for sale and in grams per stated quantity of ready-to-serve food,
(ii) the energy value expressed in calories per 100 grams or in calories per 100 millilitres of the food as offered for sale and in grams per a stated quantity of the food when ready-to-serve,
(iii) the quantity of all vitamins and mineral nutrients set out in Table II to this Division in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the food as offered for sale and in International Units or milligrams in a stated quantity of the food when ready-to-serve, and
(iv) the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) in milligrams or grams per 100 grams or in milligrams or grams per 100 millilitres of the food as offered for sale and in milligrams or grams in a stated quantity of the food when ready-to-serve;
(e) adequate directions for the preparation, use and storage of the food after the container has been opened; and
(f) the expiration date of the food.
B.25.058 Notwithstanding section D.02.005, no person shall make any claim with respect to the iron content of a human milk substitute except as required by paragraph B.25.057(1)(c), unless the human milk substitute contains at least one milligram of iron per 100 available kilocalories.
B.25.059 No person shall, on the label of or in any advertisement for a human milk substitute or a food represented as containing a human milk substitute, make any statement or claim relating to the content in the food of
(a) the percentage of the daily value of
(i) fat,
(ii) saturated fatty acids and trans fatty acids,
(iii) sodium,
(iv) potassium,
(v) carbohydrate,
(vi) fibre, or
(vii) cholesterol; or
(b) the number of Calories from
(i) fat, or
(ii) saturated fatty acids and trans fatty acids.
B.25.060 (1) Where the manufacturer of a human milk substitute or of a food that is represented as containing a human milk substitute is requested in writing by the Director to submit on or before a specified day evidence with respect to the human milk substitute, the manufacturer shall make no further sales of that human milk substitute or food that is represented as containing human milk substitute after that day unless he has submitted the evidence requested.
(2) Where the Director is of the opinion that the evidence submitted by a manufacturer pursuant to subsection (1) is not sufficient, he shall notify the manufacturer in writing that the evidence is not sufficient.
(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to the human milk substitute is not sufficient, he shall make no further sales of that human milk substitute or of that food that is represented as containing the human milk substitute unless he submits further evidence and is notified in writing by the Director that the further evidence is sufficient.
(4) In this section, evidence with respect to the human milk substitute means
(a) evidence that establishes that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; and
(b) the results of tests carried out to determine the expiration date of the human milk substitute.
B.25.061 (1) Subject to subsection (2), no person shall include on the label of a food any representation respecting the consumption of the food by an infant who is less than six months of age.
(2) Subsection (1) does not apply in respect of a human milk substitute or a new human milk substitute.
B.25.062 (1) Subject to subsection (2), no person shall sell a food that is labelled or advertised for consumption by infants if the food contains a food additive.
(2) Subsection (1) does not apply to
(a) bakery products that are labelled or advertised for consumption by infants;
(b) ascorbic acid used in cereals containing banana and fruit purees that are labelled or advertised for consumption by infants;
(c) soyabean lecithin used in rice cereal labelled or advertised for consumption by infants;
(d) citric acid used in foods that are labelled or advertised for consumption by infants;
(e) infant formula that contains the food additives set out in Tables IV and X to section B.16.100 for use in infant formula; or
(f) infant formula that contains ingredients manufactured with food additives set out in Table V to section B.16.100.
TABLE I
SODIUM CONTENT IN INFANT FOODS
Column IColumn IIFoodTotal Sodium in Grams per 100 Grams of Food1Junior Desserts 0.102Junior Meat, Junior Meat Dinners, Junior Dinners, Junior Breakfasts 0.253Junior Vegetables, Junior Soups 0.204Strained Desserts 0.055Strained Meats, Strained Meat Dinners, Strained Dinners, Strained Breakfasts 0.156Strained Vegetables, Strained Soups 0.10TABLE II
Column IColumn IIColumn IIIItem No.Vitamin or Mineral nutrientMinimum amount per 100 available kilocaloriesMaximum amount per 100 available kilocaloriesB.1Biotin2 mcg—F.1Folic acid4 mcg—N.1Niacin250 mcg—P.1d-pantothenic acid300 mcg—R.1Riboflavin60 mcg—T.1Thiamine40 mcg—T.2Alpha-tocopherol0.6 I.U.—V.1Vitamin A250 I.U.500 I.U.V.2Vitamin B635 mcg—V.3Vitamin B120.15 mcg—V.4Vitamin C8 mg—V.5Vitamin D40 I.U.80 I.U.V.6Vitamin K18 mcg—C.1Calcium50 mg—C.2Chloride55 mg150 mgC.3Copper60 mcg—L.1Iodine5 mcg—L.2Iron0.15 mg—M.1Magnesium6 mg—M.2Manganese5 mcg—P.2Phosphorous25 mg—P.3Potassium80 mg200 mgS.1Sodium20 mg60 mgZ.1Zinc0.5 mg—DIVISION 26
Food Irradiation
Interpretation
B.26.001 In this Division,
ionizing radiation
ionizing radiation means
(a) gamma-radiation from a Cobalt-60 or Cesium-137 source,
(b) X-rays generated from a machine source operated at or below an energy level of 5 MeV, and
(c) electrons generated from a machine source operated at or below an energy level of 10 MeV; (rayonnement ionisant)
irradiation
irradiation means treatment with ionizing radiation. (irradiation)
Application
B.26.002 This Division does not apply to foods exposed to ionizing radiation from a measuring instrument used to determine weight, estimate bulk solids, measure the total solids in liquids or perform other inspection procedures.
General
B.26.003 (1) Subject to subsection (2), no person shall sell a food that has been irradiated.
(2) A food set out in Column I of an item of the table to this Division that has been irradiated may be sold if
(a) the food was irradiated from a source set out in Column II of that item for the purpose set out in Column III of that item; and
(b) the dose of ionizing radiation absorbed by the food is within the permitted absorbed dose set out in Column IV of that item.
Records
B.26.004 (1) A manufacturer who sells a food that has been irradiated shall keep on his premises, for at least two years after the date of the irradiation, a record containing the following information:
(a) the food irradiated and the quantity and lot numbers of the food;
(b) the purpose of the irradiation;
(c) the date of the irradiation;
(d) the dose of ionizing radiation absorbed by the food;
(e) the source of the ionizing radiation; and
(f) a statement indicating whether the food was irradiated prior to the irradiation by the manufacturer and, if so, the information referred to in paragraphs (a) to (e) in respect of that prior irradiation.
(2) Every person who imports a food that is intended for sale in Canada that has been irradiated shall keep on his premises a record of the information referred to in subsection (1) for at least two years after the date of importation.
Changes to the Table
B.26.005 A request that a food be added or a change made to the table to this Division shall be accompanied by a submission to the Director containing the following information:
(a) the purpose and details of the proposed irradiation, including the source of ionizing radiation and the proposed frequency of and minimum and maximum dose of ionizing radiation;
(b) data indicating that the minimum dose of ionizing radiation proposed to be used accomplishes the intended purpose of the irradiation and the maximum dose of ionizing radiation proposed does not exceed the amount required to accomplish the purpose of the irradiation;
(c) information on the nature of the dosimeter used, the frequency of the dosimetry on the food and data pertaining to the dosimetry and phantoms used to assure that the dosimetry readings reflect the dose absorbed by the food during irradiation;
(d) data indicating the effects, if any, on the nutritional quality of the food, raw and ready-to-serve, under the proposed conditions of irradiation and any other processes that are combined with the irradiation;
(e) data establishing that the irradiated food has not been significantly altered in chemical, physical or microbiological characteristics to render the food unfit for human consumption;
(f) where the Director so requests, data establishing that the proposed irradiation is safe under the conditions proposed for the irradiation;
(g) the recommended conditions of storage and shipment of the irradiated food including the time, temperature and packaging and a comparison of the recommended conditions for the same food that has not been irradiated;
(h) details of any other processes to be applied to the food prior to or after the proposed irradiation; and
(i) such other data as the Director may require to establish that consumers and purchasers of the irradiated food will not be deceived or misled as to the character, value, composition, merit or safety of the irradiated food.
TABLE
ItemColumn IColumn IIColumn IIIColumn IVFoodPermitted Sources of Ionizing RadiationPurpose of TreatmentPermitted Absorbed Dose1Potatoes (Solanum tuberosum L.
)Cobalt-60To inhibit sprouting during storage0.15 kGy max.2Onions (Allium cepa
)Cobalt-60To inhibit sprouting during storage0.15 kGy max.3Wheat, Flour, Whole Wheat Flour (Triticum sp.
)Cobalt-60To control insect infestation in stored food0.75 kGy max.4Whole or ground spices and dehydrated seasoning preparationsCobalt-60, Cesium-137, or electrons from machine sources (3 MeV max.)To reduce microbial load10.00 kGy max. total overall average doseDIVISION 27
Low-Acid Foods Packaged In Hermetically Sealed Containers
B.27.001 In this Division,
commercially sterile
commercially sterile means the condition obtained in a food that has been processed by the application of heat, alone or in combination with other treatments, to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage; (stérilité commerciale)
hermetically sealed container
hermetically sealed container means a container designed and intended to be secure against the entry of microorganisms, including spores; (récipient hermétiquement fermé)
low-acid food
low-acid food means a food, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85; (aliment peu acide)
refrigeration
refrigeration means exposure to a temperature of 4°C or less but does not mean frozen; (réfrigéré)
shipping container
shipping container means a receptacle, package or wrapper in which containers of food are placed for transportation; (contenant d’expédition)
water activity
water activity means the ratio of the water vapour pressure of a food to the vapour pressure of pure water, at the same temperature and pressure. (activité de l’eau)
B.27.002 (1) No person shall sell a low-acid food packaged in a hermetically sealed container unless the food is commercially sterile.
(2) Subsection (1) does not apply in respect of a low-acid food packaged in a hermetically sealed container where
(a) the low-acid food is kept under refrigeration and the statement “Keep Refrigerated” and “Garder au froid” is carried on the principal display panel of the label of its container, as well as on the label of its shipping container; or
(b) the low-acid food is kept frozen and the statement “Keep Frozen” and “Garder congelé” is carried on the principal display panel of the label of its container, as well as on the label of its shipping container.
(3) Subsection (1) does not apply in respect of tomatoes or tomato products packaged in hermetically sealed containers where the tomatoes or tomato products have a pH of 4.7 or less after heat processing.
B.27.003 No person shall sell a low-acid food packaged in a hermetically sealed container where the container
(a) is swollen;
(b) is not properly sealed; or
(c) has any defect that may adversely affect its hermetic seal.
B.27.004 (1) Where, in the opinion of the Director, the sale of a low-acid food packaged in a hermetically sealed container may contravene section B.27.002 or B.27.003, the Director may, by notice in writing, request that the manufacturer or importer of the food submit, on or before the date specified in the notice, evidence that establishes that the processes used to manufacture, process and package the food rendered and maintained the food commercially sterile.
(2) Where a manufacturer or an importer receives a notice issued pursuant to subsection (1), the manufacturer or importer shall make no further sales of the food on or after the day specified in the notice until he has submitted the evidence requested in that notice.
(3) Where the Director is of the opinion that the evidence submitted by a manufacturer or importer pursuant to subsection (1) is not sufficient, the Director shall notify the manufacturer or importer in writing that the evidence is not sufficient.
(4) Where, pursuant to subsection (3), a manufacturer or importer is notified that the evidence he has submitted is not sufficient, the manufacturer or importer shall make no further sales of the food until he submits further evidence and is notified in writing by the Director that the further evidence is sufficient.
B.27.005 No person shall sell a commercially sterile low-acid food packaged in a hermetically sealed container unless
(a) the label or container of the food bears a code or lot number that identifies, in a legible and permanent manner,
(i) the establishment in which the product was rendered commercially sterile, and
(ii) the day, month and year on which the food was rendered commercially sterile; and
(b) the exact meaning of each item in any code or lot number referred to in paragraph (a) is available to an inspector at the establishment or, where the food is imported, from the importer.
DIVISION 28
Novel Foods
Interpretation
B.28.001 The definitions in this section apply in this Division.
genetically modify
genetically modify means to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation. (modifier génétiquement)
major change
major change means, in respect of a food, a change in the food that, based on the manufacturer’s experience or generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to
(a) the composition, structure or nutritional quality of the food or its generally recognized physiological effects;
(b) the manner in which the food is metabolized in the body; or
(c) the microbiological safety, the chemical safety or the safe use of the food. (changement majeur)
novel food
novel food means
(a) a substance, including a microorganism, that does not have a history of safe use as a food;
(b) a food that has been manufactured, prepared, preserved or packaged by a process that
(i) has not been previously applied to that food, and
(ii) causes the food to undergo a major change; and
(c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that
(i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,
(ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or
(iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism. (aliment nouveau)
Pre-market notification
B.28.002 (1) No person shall sell or advertise for sale a novel food unless the manufacturer or importer of the novel food
(a) has notified the Director in writing of their intention to sell or advertise for sale the novel food; and
(b) has received a written notice from the Director under paragraph B.28.003(1)(a) or subsection B.28.003(2).
(2) A notification referred to in paragraph (1)(a) shall be signed by the manufacturer or importer, or a person authorized to sign on behalf of the manufacturer or importer, and shall include the following information:
(a) the common name under which the novel food will be sold;
(b) the name and address of the principal place of business of the manufacturer and, if the address is outside Canada, the name and address of the principal place of business of the importer;
(c) a description of the novel food, together with
(i) information respecting its development,
(ii) details of the method by which it is manufactured, prepared, preserved, packaged and stored,
(iii) details of the major change, if any,
(iv) information respecting its intended use and directions for its preparation,
(v) information respecting its history of use as a food in a country other than Canada, if applicable, and
(vi) information relied on to establish that the novel food is safe for consumption;
(d) information respecting the estimated levels of consumption by consumers of the novel food;
(e) the text of all labels to be used in connection with the novel food; and
(f) the name and title of the person who signed the notification and the date of signing.
B.28.003 (1) Within 45 days after receiving a notification referred to in paragraph B.28.002(1)(a), the Director shall review the information included in the notification and
(a) if the information establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient; or
(b) if additional information of a scientific nature is necessary in order to assess the safety of the novel food, request in writing that the manufacturer or importer submit that information.
(2) Within 90 days after receiving the additional information requested under paragraph (1)(b) the Director shall assess it and, if it establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient.
PART C
Drugs
Division 1
General
C.01.001 (1) In this Part
acetaminophen product
acetaminophen product has the same meaning as in Division 9; (produit d’acétaminophène)
adult standard dosage unit
adult standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour adultes)
adverse drug reaction
adverse drug reaction means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; (réaction indésirable à une drogue)
antibiotic
antibiotic means any drug or combination of drugs such as those named in C.01.410 to C.01.592 which is prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; (antibiotique)
brand name
brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,
(a) that is assigned to the drug by its manufacturer,
(b) under which the drug is sold or advertised, and
(c) that is used to distinguish the drug; (marque nominative)
case report
case report means a detailed record of all relevant data associated with the use of a drug in a subject; (fiche d’observation)
children’s standard dosage unit
children’s standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour enfants)
child resistant package
child resistant package means a package that meets the requirements of subsection (2); (emballage protège-enfants)
common name
common name means, with reference to a drug, the name in English or French by which the drug is
(a) commonly known, and
(b) designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act; (nom usuel)
expiration date
expiration date means the earlier of
(a) the date, expressed at minimum as a year and month, up to and including which a drug maintains its labelled potency, purity and physical characteristics, and
(b) the date, expressed at minimum as a year and month, after which the manufacturer recommends that the drug not be used; (date limite d’utilisation)
immediate container
immediate container means the receptacle that is in direct contact with a drug; (récipient immédiat)
internal use
internal use means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane; (usage interne)
official drug
official drug means any drug
(a) for which a standard is provided in these Regulations, or
(b) for which no standard is provided in these Regulations but for which a standard is provided in any of the publications mentioned in Schedule B to the Act; (drogue officielle)
parenteral use
parenteral use means administration of a drug by means of a hypodermic syringe, needle or other instrument through or into the skin or mucous membrane; (usage parentéral)
per cent
per cent means per cent by weight unless otherwise stated; (pour cent)
practitioner
practitioner means a person authorized by the law of a province of Canada to treat patients with any drug listed or described in Schedule F to the Regulations; (praticien)
prescription
prescription means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order; (ordonnance)
proper name
proper name means, with reference to a drug, the name in English or French
(a) assigned to the drug in section C.01.002,
(b) that appears in bold-face type for the drug in these Regulations and, where the drug is dispensed in a form other than that described in this Part, the name of the dispensing form,
(c) specified in the Canadian licence in the case of drugs included in Schedule C or Schedule D to the Act, or
(d) assigned in any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c); (nom propre)
salicylate product
salicylate product has the same meaning as in Division 9; (produit de salicylate)
serious adverse drug reaction
serious adverse drug reaction means a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death; (réaction indésirable grave à une drogue)
serious unexpected adverse drug reaction
serious unexpected adverse drug reaction means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug; (réaction indésirable grave et imprévue à une drogue)
teaspoon
teaspoon means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres; (cuillerée à thé)
test group
test group means a group that meets the requirements of subsection (3); (groupe d’essai)
withdrawal period
withdrawal period means the length of time between the last administration of a drug to an animal and the time when tissues or products collected from the treated animal for consumption as food contain a level of residue of the drug that would not likely cause injury to human health. (délai d’attente)
(2) A child resistant package is a package that
(a) when tested in accordance with an acceptable method,
(i) in the case of a test group comprising children, cannot be opened
(A) by at least 85 per cent of those children prior to a demonstration to them of the proper means of opening the package, and
(B) by at least 80 per cent of those children after the demonstration, and
(ii) in the case of a test group comprising adults
(A) can be opened by at least 90 per cent of those adults, and
(B) where the package is designed so that, once opened and reclosed, it continues to meet the requirements of subparagraph (i), can be so reclosed by at least 90 per cent of those adults; or
(b) complies with the requirements of one of the following standards, namely,
(i) Canadian Standards Association Standard CAN/CSA-Z76.1-M90, entitled Recloseable Child-Resistant Packages, published January 1990, as amended from time to time,
(ii) European Standard EN 28317:1992, entitled Child-resistant packaging—Requirements and testing procedures for reclosable packages, as adopted by the European Committee for Standardization on October 30, 1992, recognized by the British Standards Institution, and effective February 15, 1993 and by the Association française de normalisation, and effective December 20, 1992, and which reiterates fully the international standard ISO 8317:1989, as amended from time to time, and
(iii) Code of Federal Regulations (United States), Title 16, Section 1700.15, entitled Poison prevention packaging standards, as amended from time to time.
(3) For the purposes of this section, test group means
(a) in relation to children, a group of at least 200 children who
(i) are healthy and have no obvious physical or mental disability,
(ii) are between 42 and 51 months of age, and
(iii) represent evenly, within plus or minus 10 per cent, each monthly age between 42 and 51 months calculated to the nearest month; and
(b) in relation to adults, a group of at least 100 adults who
(i) are healthy and have no obvious physical or mental disability,
(ii) are between 18 and 45 years of age, and
(iii) represent evenly, within plus or minus 10 per cent, each yearly age between 18 and 45 years calculated to the nearest year.
(4) For the purpose of this section, an amendment from time to time to a standard referred to in paragraph (2)(b) becomes effective 18 months after the date designated by the competent authority as the effective date for the amendment.
C.01.001A [Repealed, SOR/98-423, s. 1]
C.01.002 The Proper Name of a drug shown opposite an item number in the following Table in the column headed “Chemical Names and Synonyms” shall be the name shown opposite that item number in the column headed “Proper Names”.
TABLE
Item No.Proper NamesChemical Names and SynonymsA.1Acepromazine 2-acetyl-10-(3-dimethylaminopropyl) iephenothiazineA.2Acetaminophen p-Acetaminophenol, Paracetamol, p-Hydroxyacetanilide: N-acetyl-p-aminophenolA.3Acetanilide: Acetanilid Acetylaminobenzene: Antifebrin: PhenylacetamideA.4Acetylsalicylic Acid Acetylsalicylic acidA.5Allopurinol 1-H-Pyrazolo [3,4-d] pyrimidin-4-ol: 4-Hydroxypyrazolo (3,4-d) pyrimidineA.6Amantadine 1-AdamantanamineA.7Aminocaproic acid 6-Aminohexanoic acidA.8Aminopterin N-[4-(2,4-diamino-6-pteridyl methyl) amino-benzoyl]-L- glumatic acidA.9Aminopyrine: Amidopyrine 1,5-dimethyl-2-phenyl-4-dimethylamino-3-pyrazolone: DimethylaminophenazoneA.10Amitriptyline 3-(3-Dimethylaminopropylidene)-1,2: 4,5-dibenzocyclohepta-1,4-dieneA.11Azacyclonol α,α-diphenyl-4-piperidinecarbinolB.1Bemegride 3-Ethyl-3-methylglutarimideB.2Benactyzine Dimethylaminoethyl-1,1-diphenylglycolateB.3Bendroflumethiazide 3-benzyl-3,4-dihydro-6-(trifluoro- methyl)-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide: Bendrofluazide (B.A.N.)B.4Betahistine 2-[2-(Methylamino)ethyl] pyridineB.5Bethanidine N-Benzyl-N′N″-dimethylguanidine: 1-Benzyl-2,3-dimethylguanidineB.6Bretylium tosylate N-2-Bromobenzyl-N-ethyl-N, N-dimethylammonium tosylate (Tosylic acid is trivial name for p-toluenesulphonic acid)B.7Bromisoval 2-monobromoisovalerylurea: Bromisovalum: BromvalitoneC.1Calcium Carbimide Calcium cyanamideC.2Captodiamine 4-butylthio-α-phenylbenzyl-2- dimethylaminoethylsulfideC.3Carisoprodol N-Isopropyl-2-methyl-2-propyl-1, 3-propanediol dicarbamateC.4Carphenazine 1-[10-(3[4-(2-Hydroxyethyl)-1-piperazinyl]propyl) phenothiazin-2yl]-1-propaponeC.5Cephaloridine 7-[(2-Thienyl) acetamido]-3-(1-pyridylmethyl)-3-cephem-4-carboxylic acid betaineC.6Chlormezanone 2-(4-chlorophenyl)-3-methyl-4-methathiazanone-1,1-dioxide: Chlormethazone: ChlormethazanoneC.7Chloromethapyrilene N,N-dimethyl-N′-(2-pyridyl)-N′-(5-chloro-2-thenyl)-ethylenediamine: ChlorothenC.8Chlorphentermine 4-Chloro-α,α-dimethylphenethylamineC.9Cinchocaine 2-butoxy-N-(2-diethylaminoethyl) cinchoninamide: DibucaineC.10Cinchophen 2-phenylquinoline-4-carboxylic acid: QuinophanC.11Clofibrate Ethyl 2-(p-chlorophenoxy)-2-methylpropionateC.12Clomiphene 1-Chloro-2-[4-(2-diethylamino-ethoxy)phenyl]-1,2-diphenylethylene: 2-[p-(2-Chloro-1,2-diphenylvinyl)phenoxy] triethylamineD.1Desipramine 5-(3-Methylaminopropyl)-10,11-dihydro-5H-dibenz[b,f]azepineD.2Diazepam 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-oneD.3Diethylpropion 1-phenyl-2-diethylaminopropanone-1D.4Diphenidol 1,1-Diphenyl-4-piperidinobutan-1-olD.5Disulfiram Tetraethylthiuram disulphideE.1Ectylurea 2-ethyl-cis-crotonylureaE.2Emylcamate 1-Ethyl-1-methylpropyl carbamateE.3Ethacrynic Acid [2,3-Dichloro-4-(2-methylenebutyryl) phenoxy] acetic acid: 2,3-Dichloro-4-(2-ethylacryloyl) phenoxyacetic acidE.4Ethchlorvynol 3-(2-chlorovinyl)-1-pentyn-3-olE.5Ethinamate 1-ethynylcyclohexyl carbamateE.6Ethionamide 2-EthylisonicotinthioamideE.7Ethomoxane 2-n-Butylaminomethyl-8-ethoxy-benzo-1,4-dioxanE.8Ethyl Trichloramate Ethyl n-[1-(2,2,2,-trichloro-1-hydroxyethyl)] carbamateE.9Etryptamine 3-(2-Aminobutyl) indoleE.10Etymemazine 10-(3-Dimethylamino-2-methylpro-pyl)-2-ethylphenothiazineF.1Fluphenazine 10-{3-[4-(2-Hydroxyethyl) piperazin-1-yl] propyl}-2-tri-fluoromethylphenothiazineF.2Furosemide 4-Chloro-N-furfuryl-5-sulphamoylanthranilic acid: Frusemide (B.A.N.)G.1Glyburide 5-chloro-N-[2-[4-[[[(cyclohexylamino carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxy benzamide: 1-4[4-[2-(5-chloro-2-methoxybenzamido)ethyl]phenyl- sulfonyl]-3-cyclohexylurea: GlibenclamideH.1Haloperidol 4-(4-Chlorophenyl)-1-[3-(4-fluorobenzoyl) propyl]-piperidin-4-ol: 4-[4-(p-Chlorophenyl)-4-hydro-xypiperidino]-4’-fluorobutyro-phenoneH.2Hydroxychloroquine 7-Chloro-4[4-(N-ethyl-N-2-hydro-xyethylamino)-1-methylbutyl-amino] quinolineH.3Hydroxyzine 1-(p-chloro-α-phenylbenzyl)-4-(2-hydroxy ethoxyethyl) piperazineI.1Idoxuridine 5-Iodo-2′-deoxyuridineI.2Imipramine 5-(3-dimethylaminopropyl)-10,11-dihydro-5H-dibenz[b,f]azepineI.3Indomethacin 1-(p-Chlorobenzoyl)-5-methoxy-2-methyl-indole-3-acetic acidI.4Iproniazid 1-isonicotinoyl-2-isopropylhydrazineI.5Isocarboxazid 3-N-Benzylhydrazinocarbonyl-5-methylisoxazoleI.6Isoproterenol 3,4-Dihydroxy-α-[isopropylamino) methyl] benzyl alcohol: IsoprenalineL.1Liothyronine L-α-Amino-3-[(4-hydroxy-3-iodophenoxy)-3,5-di-iodo-phenyl] propionic acidM.1Mefenamic acid N-(2,3-Xylyl)-anthranilic acidM.2Melphalan 4-Di-(2-chlorethyl)amino-L-phenylalanineM.3Mepazine 10-[(1-methyl-3-piperidyl) methyl] phenothiazineM.4Mephenesin 3-o-toloxy-1,2-propanediolM.5Mephenoxalone 5-(o-Methoxyphenoxymethyl)-2-oxazolidinoneM.6Meprobamate 2,2-di(carbamoylmethyl) pentaneM.7Methaqualone 2-Methyl-3-o-tolyquinazolin-4-one: 2-Methyl-3-o-tolyl-4-quinazoloneM.8Methisazone 1-Methylindoline-2,3-dione-3-thiosemicarbazone: N-Methylisatin-ß-thiosemicarbazoneM.9Methotrimeprazine 10-[3-(2-Methyl)dimethylamino propyl]-2-methoxyphenothiazine: LevomepromazineM.10Methyldopa 1-3(3,4-Dihydroxyphenyl)-2-methylalanineM.11Methylparafynol 3-methyl-1-pentyn-3-ol: MethylpentynolM.12Methylphenidate Methyl-1-phenyl-1-(2-piperidyl) acetateM.13Methyprylon 3,3-diethyl-5-methyl-2,4-piperidinedioneM.14Methysergide 1-(Hydroxymethyl)propylamide of 1-methyl-d-lysergic acidM.15Metyrapone 2-Methyl-1,2-di(3-pyridyl)propan-1-oneN.1Nalidixic Acid 1-Ethyl-7-methyl-4-oxo-1,8-naphthyridine-3-carboxylic acidN.2Nialamide 1-[2-(benzycarbamyl)ethyl]-2-isonicotinoyl-hydrazineN.3Nortriptyline 3-(3-Methylaminopropylidene)-1,2, 4,5-dibenzocyclohepta-1,4-dieneO.1Oxanimide 2-ethyl-3-propyl-glycidamideO.2Oxazepam 7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-1,4-benzodiazepin-2-oneO.3Oxyphenbutazone 4-n-Butyl-2-(4-hydroxyphenyl)-1-phenyl-pyrazolidine-3,5-dioneP.1Paramethadione 3,5-dimethyl-5-ethyl-2,4-oxazolidinedioneP.2Pargyline N-Benzyl-N-methylprop-2-ynylamineP.3Pemoline 2-Imino-5-phenyloxazolidin-4-oneP.4Pentazocine 1,2,3,4,5,6-Hexahydro-8-hydroxy-6,11-dimethyl-3-(3-methylbut-2-enyl)-2,6-methano-3-benzazocine: 1,2,3,4,5,6-Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-olP.5Pentolinium Tartrate NN′-Pentamethylenedi-(methylpryrrolidinium hydrogen, tartrate)P.6Perphenazine 2-chloro-10-{3-[1-(2-hydroxyethyl)-4-piperazinyl]propyl} phenothiazineP.7Phacetoperane l-1-Phenyl-1(2′-piperidyl)-1-acetoxymethaneP.8Phenacemide (Phenylacetyl)ureaP.9Phenacetin p-acetphenetidin: Acetphenetidin: Acetophenetidin: p-ethoxyacetanilidP.10Phenaglycodol 2-p-chlorophenyl-3-methyl-2,3-butanediolP.11Phendimetrazine 3,4-Dimethyl-2 PhenylmorpholineP.12Phenelzine 2-phenylethylhydrazineP.13Phenformin N′-ß-phenethylformamidinyliminoureaP.14Pheniprazine α-MethylphenethylhydrazineP.15Phenmetrazine Tetrahydro-3-methyl-2-phenyl-1,4-oxazine: 3-methyl-2-phenylmorpholineP.16Phentermine α, α-Dimethylphenethylamine: phenyl-tert-butylamineP.17Phenylindanedione 2-phenylindane-1,3-dioneP.18Phenyltoloxamine N,N-dimethyl-2-(α-phenyl-o-tolyloxy) ethylamineP.19Pholedrine p-(4-hydroxyphenyl)-isopropylmethylamineP.20Piperliate 1-piperidine-ethanol benzilateP.21Pipradol Diphenyl-2-piperidylmethanolP.22Prochlorperazine 2-Chloro-10-[3-(1-methyl-4-piperazinyl) propyl]phenothiazineP.23Prodilidine 1,2-Dimethyl-3-phenyl-3-pyrrolidinyl propionateP.24Propranolol 1-(Isopropylamino)-3-(1-naphthyloxy)-2-propanolP.25Prothipendyl 9-(3-Dimethylaminopropyl)-10-thia-1,9-diaza-anthraceneP.26Protriptyline 7-(3-Methylaminopropyl)-1,2:5,6-dibenzocycloheptatrien: N-Methyl-5H-dibenzo [a, d] cycloheptene-5-propylamineP.27Pyrazinamide Pyrazinoic acid amideR.1Rifampin 3-{[(4-methyl-1-piperazinyl)imino]methyl} rifamycin SV : Rifampicin (I.N.N.) (Rifamycin SV is an antibiotic produced byStreptomyces mediterranei
)S.01Sodium Cromoglycate 4H-1-Benzopyran-2-carboxylic acid, 5,5′-[(2-hydroxy-1,3-propanediyl) bis(oxy)]bis[4-oxo-,disodium salt]:Disodium 5,5′-(2-hydroxytrimethylenedioxy) bis[4-oxo-4H-1-benzopyran-2- carboxylate]: Disodium 4,4′-dioxo-5,5′-(2-hydroxytrimethylenedioxy)di (chromene-2-carboxylate): Cromolyn Sodium (USP): Disodium CromoglycateS.1Sulfameter 2-(4-Aminobenzenesulphonamido)-5-methoxypyrimidine: N′-(5-methoxy-2-pyrimidinyl) sulfanilamide: Sulfamethoxydiazine (B.A.N.)S.2Sulfamethazine N′-(4,6-dimethyl-2- pyrimidyl)sulfanilamide: 2-(p-aminobenzenesulphonamide)-4,6-dimethylpyrimidine: sulphadimedineS.3Sulfinpyrazone 1,2-diphenyl-4-(2-phenylsulfinilethyl)-3,5-pyrazolidinedioneS.4Sulfisoxazole 3,4-dimethyl-5-sulfanilamidoisoxazole: SulphafurazoleT.1Tetracaine 2-dimethylaminoethyl-p-n- butylaminobenzoate: AmethocaineT.2Thiethylperazine 2-Ethylthio-10-[3-(4- methylpiperazin-1-yl) propyl]phenothiazineT.3Thiopropazate 2-chloro-10-[3-[1-(2-acetoxyethyl)-4-piperazinyl] propyl]phenothiazineT.4Thioproperazine 2-Dimethylsulphamoyl-10-[3-(4-methylpiperazin-1-yl)- propyl]phenothiazineT.5Thioridazine 10-{2-[2-(1-methylpiperidyl)] ethyl α}-2-methylthiopheno- thiazineT.6Tranylcypromine Trans d, 1-2-phenylcyclopropyl- amineT.7Triamterene 2,4,7-Triamino-6-phenylpteridineT.8Triflupromazine 10-(3-dimethylaminopropyl)-2-trifluoromethylphenothiazine: FluopremazineT.9Trimeprazine 10-(3-dimethylamino-2-methylpropyl) phenothiazineT.10Trimethadione 3,5,5-trimethyl-2,4-oxazolidine- dione: TroxidoneT.11Trimipramine 5-(3-Dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenz[b,f]azepine: 5-(3′-Dimethylamino-2′-methylpropyl)iminodibenzylT.12Tybamate 2-Methyl-2-propyltrimethylene butylcarbamate carbamate: 2-(Hydroxymethyl)-2-methyl-pentyl butylcarbamate carbamateV.1Vinblastine An alkaloid derived fromVinca rosea
V.2Vincristine An alkaloid derived fromVinca rosea
C.01.003 No person shall sell a drug that is not labelled as required by these Regulations.
C.01.004 (1) The inner and outer labels of a drug shall show
(a) on the principal display panel
(i) the proper name, if any, of the drug which, if there is a brand name for the drug, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name,
(ii) if there is no proper name, the common name of the drug,
(iii) where a standard for the drug is prescribed in Division 6 of this Part, a statement that the drug is a Canadian Standard Drug, for which the abbreviation C.S.D. may be used,
(iv) where a standard for the drug is not prescribed in Division 6 of this Part but is contained in a publication mentioned in Schedule B to the Act, the name of the publication containing the standard used or its abbreviation as provided in Schedule B or, if a manufacturer’s standard is used, a statement setting forth the fact that such a standard is used, and
(v) in both official languages, the notation sterilestérile if the drug is required to be sterile by these Regulations;
(b) on the upper left quarter of the principal display panel
(i) the symbol Pr in the case of a drug required by this Part or Part D to be sold on prescription, but in no other case shall the symbol Pr appear on the label of a drug,
(ii) the symbol “” in a clear manner and a conspicuous colour and size, in the case of a controlled drug, other than a controlled drug contained in an agricultural implant and set out in Part III of the schedule to Part G,
(iii) the symbol “N” in a colour contrasting with the rest of the label or in type not less than half the size of any letters used thereon, in the case of a narcotic as defined in the Narcotic Control Regulations, and
(iv) in the case of a targeted substance as defined in subsection 1(1) of the Benzodiazepines and Other Targeted Substances Regulations, the following symbol in a colour contrasting with the rest of the label and in type not less than half the size of any other letter used on the main panel, namely,
(c) on any panel
(i) the name and address of the manufacturer of the drug,
(ii) the lot number of the drug,
(iii) adequate directions for use of the drug,
(iv) a quantitative list of the medicinal ingredients of the drug by their proper names or, if they have no proper names, by their common names, and
(v) the expiration date of the drug.
(2) In addition to the requirements of subsection (1), the outer label of a drug shall show
(a) the net amount of the drug in the container in terms of weight, measure or number;
(b) in the case of a drug intended for parenteral use, a quantitative list of any preservatives present therein by their proper names or, if they have no proper names, by their common names; and
(c) in the case of a drug for human use that contains mercury or a salt or derivative thereof as a preservative, a quantitative list of all mercurial preservatives present therein by their proper names or, if they have no proper names, by their common names.
(3) Where the container of a drug is too small to accommodate an inner label that conforms to the requirements of these Regulations, the inner label requirements of these Regulations do not apply to the drug in that container if
(a) there is an outer label that complies with the labelling requirements of these Regulations; and
(b) the inner label shows
(i) the proper name of the drug, the common name of the drug if there is no proper name or, in the case of a drug with more than one medicinal ingredient, the brand name of the drug,
(ii) the potency of the drug except where, in the case of a drug with more than one medicinal ingredient, the name used pursuant to subparagraph (i) for that drug is unique for a particular potency of the drug,
(iii) the net contents of the drug if it is not in a discrete dosage form,
(iv) the route of administration of the drug if other than oral,
(v) the lot number of the drug,
(vi) the name of the manufacturer of the drug,
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(vii) the expiration date of the drug, and
(viii) the identification of special characteristics of the dosage form if they are not evident from the name of the drug under subparagraphs (i) or (ii).
(4) [Repealed, SOR/92-654, s. 2]
(5) This section does not apply to
(a) a drug sold to a drug manufacturer; or
(b) a drug dispensed pursuant to a prescription, if its label carries suitable directions for use and complies with the requirements of section C.01.005.
C.01.004.1 (1) No person shall import a drug in dosage form into Canada for the purpose of sale unless they have in Canada a person who is responsible for the sale of the drug.
(2) No person who imports a drug in dosage form into Canada shall sell any lot or batch of the drug unless the name of the person who imports it, and the address of the principal place of business in Canada of the person responsible for its sale, appears on the inner and outer labels of the drug.
C.01.005 (1) The principal display panel of both the inner and outer label of a drug sold in dosage form shall show in a clear and legible manner the drug identification number assigned by the Director for that drug pursuant to subsection C.01.014.2(1), preceded by the words “Drug Identification Number” or “Drogue : identification numérique” or both, or the letters “DIN”.
(2) Subsection (1) does not apply to a drug
(a) compounded by a pharmacist pursuant to a prescription or by a practitioner; or
(b) sold pursuant to a prescription, where the label of that drug indicates:
(i) the proper name, the common name or the brand name of the drug,
(ii) the potency of the drug, and
(iii) the name of the manufacturer of the drug.
(3) For the purposes of this section and section C.01.014, a drug in dosage form means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing.
(4) and (5) [Repealed, SOR/81-248, s. 1]
C.01.006 Where a package of a drug has only one label, that label shall contain all the information required by these Regulations to be shown on both the inner and the outer labels.
C.01.007 No reference, direct or indirect, to the Act or to these Regulations shall be made upon any label of or in any advertisement for a drug unless such reference is a specific requirement of the Act or these Regulations.
C.01.008 [Repealed, SOR/80-544, s. 2]
C.01.009 Where by any statute of the Parliament of Canada or any regulation made thereunder a standard or grade is prescribed for a drug and that standard is given a name or designation by such statute or regulation, no person shall on a label of or in any advertisement for that drug use that name or designation unless the drug conforms with the standard or grade.
C.01.010 Where it is necessary to provide adequate directions for the safe use of a parenteral drug or Schedule F drug that is used in the treatment or prevention of any disease, disorder or abnormal physical state mentioned in Schedule A to the Act, such diseases, disorders or abnormal physical state may be mentioned on the labels and inserts accompanying that drug and to such extent, that drug is hereby exempted from the provisions of section 3 of the Act.
C.01.011 (1) A drug referred to in subsection 10(2) of the Act shall be exempt from the standard for any drug contained in any publication mentioned in Schedule B to the Act to the extent that such drug differs from that standard with respect to colour, flavour, shape and size, if such difference does not interfere with any method of assay prescribed in any such publication.
(2) [Repealed, SOR/93-243, s. 2]
(3) Where a manufacturer’s standard is used for a drug, the manufacturer shall make available to the Director, on request, details of that standard and of a method of analysis for the drug acceptable to the Director.
(4) No person shall use a manufacturer’s standard for a drug that provides
(a) a lesser degree of purity than the highest degree of purity, or
(b) a greater variation in potency than the least variation in potency,
provided for that drug in any publication mentioned in Schedule B to the Act.
C.01.012 A manufacturer who makes representations on a label of a drug in oral dosage form, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of the drug, or the availability to the body of a medicinal ingredient of the drug, shall
(a) before making the representations, conduct such investigations, using an acceptable method, as may be necessary to demonstrate that the site, rate or extent of release to the body of the medicinal ingredient of the drug and the availability to the body of the medicinal ingredient of the drug, correspond to the representations; and
(b) on request submit the record of such investigations to the Director.
C.01.013 (1) Where the manufacturer of a drug is requested in writing by the Director to submit on or before a specified day evidence with respect to a drug, the manufacturer shall make no further sales of that drug after that day unless he has submitted the evidence requested.
(2) Where the Director is of the opinion that the evidence submitted by a manufacturer, pursuant to subsection (1), is not sufficient, he shall notify the manufacturer in writing that the evidence is not sufficient.
(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a drug is not sufficient, he shall make no further sales of that drug unless he submits further evidence and is notified in writing by the Director that that further evidence is sufficient.
(4) A reference in this section to evidence with respect to a drug means evidence to establish the safety of the drug under the conditions of use recommended and the effectiveness of the drug for the purposes recommended.
Assignment and Cancellation of Drug Identification Numbers
C.01.014 (1) No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned for that drug and the assignment of the number has not been cancelled pursuant to section C.01.014.6.
(2) Subsection (1) does not apply in respect of a drug listed in Schedule C to the Act, whole blood and its components, or a medicated feed as defined in section 2 of the Feeds Regulations, 1983.
C.01.014.1 (1) A manufacturer of a drug, a person authorized by a manufacturer or, in the case of a drug to be imported into Canada, the importer of the drug may make an application for a drug identification number for that drug.
(2) An application under subsection (1) shall be made to the Director in writing and shall set out the following information:
(a) the name of the manufacturer of the drug as it will appear on the label;
(b) the pharmaceutical form in which the drug is to be sold;
(c) in the case of any drug other than a drug described in paragraph (d), the recommended route of administration;
(d) in the case of a drug for disinfection in premises, the types of premises for which its use is recommended;
(e) a quantitative list of the medicinal ingredients contained in the drug by their proper names or, if they have no proper names, by their common names;
(f) the brand name under which the drug is to be sold;
(g) whether the drug is for human use, veterinary use or disinfection in premises;
(h) the name and quantity of each colouring ingredient that is not a medicinal ingredient;
(i) the use or purpose for which the drug is recommended;
(j) the recommended dosage of the drug;
(k) the address of the manufacturer referred to in paragraph (a) and, where the address is outside the country, the name and address of the importer of the drug;
(l) the name and address of any individual, firm, partnership or corporation, other than the names and addresses referred to in paragraphs (a) and (k), that will appear on the label of the drug;
(m) the written text of all labels and package inserts to be used in connection with the drug and of any further prescribing information stated to be available on request; and
(n) the name and position of the person who signed the application and the date of signature.
(3) In the case of a new drug, a new drug submission or an abbreviated new drug submission filed pursuant to section C.08.002 or C.08.002.1 shall be regarded as an application for a drug identification number.
C.01.014.2 (1) Subject to subsection (2), if a manufacturer or importer has provided all the information described in subsection C.01.014.1(2) or section C.08.002 or C.08.002.1, as the case may be, in respect of a drug, the Director shall issue to the manufacturer or importer a document that
(a) sets out
(i) the drug identification number assigned for the drug, preceded by the letters “DIN”, or
(ii) if there are two or more brand names for the drug, the drug identification numbers assigned by the Director for the drug, each of which pertains to one of the brand names and is preceded by the letters “DIN”; and
(b) contains the information referred to in paragraphs C.01.014.1(2)(a) to (f).
(2) Where the Director believes on reasonable grounds that a product in respect of which an application referred to in section C.01.014.1 has been made
(a) is not a drug, or
(b) is a drug but that its sale would cause injury to the health of the consumer or purchaser or would be a violation of the Act or these Regulations,
he may refuse to issue the document referred to in subsection (1).
(3) Where the Director, pursuant to subsection (2), refuses to issue the document, the applicant may submit additional information and request the Director to reconsider his decision.
(4) On the basis of the additional information submitted pursuant to subsection (3), the Director shall reconsider the grounds on which the refusal to issue the document was made.
C.01.014.3 The manufacturer or importer or person authorized by the manufacturer or importer shall, within 30 days after commencing sale of a drug, date and sign the document issued pursuant to subsection C.01.014.2(1) in respect of the drug and return the document
(a) with a confirmation that the information recorded therein is correct;
(b) indicating the date on which the drug was first sold in Canada; and
(c) accompanied by samples or facsimiles of all labels and package inserts and any further prescribing information stated to be available on request.
C.01.014.4 If the information referred to in subsection C.01.014.1(2) in respect of a drug is no longer correct owing to a change in the subject matter of the information,
(a) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(a) to (f)
(i) that occurs prior to the sale of the drug, a new application shall be made, or
(ii) that occurs after the sale of the drug, no further sale of the drug shall be made until a new application for a drug identification number in respect of that drug is made and a number is assigned; and
(b) in the case of a change in the subject matter of any of the information referred to in paragraphs C.01.014.1(2)(g) to (k)
(i) that occurs prior to the sale of the drug, the particulars of the change shall be submitted with the return of the document referred to in section C.01.014.3, or
(ii) that occurs after the sale of the drug, the person to whom the drug identification number in respect of that drug was issued shall, within 30 days of the change, inform the Director of the change.
C.01.014.5 Every manufacturer of a drug shall, annually before the first day of October and in a form authorized by the Director, furnish the Director with a notification signed by the manufacturer or by a person authorized to sign on his behalf, confirming that all the information previously supplied by the manufacturer with respect to that drug is correct.
C.01.014.6 (1) The Director shall cancel the assignment of a drug identification number for a drug where
(a) the person to whom the number was assigned advises that the sale or import of the drug has been discontinued;
(b) the drug is a new drug in respect of which the notice of compliance has been suspended pursuant to section C.08.006; or
(c) it has been determined that the product in respect of which the number was assigned is not a drug.
(2) The Director may cancel the assignment of a drug identification number for a drug where
(a) the manufacturer of the drug has failed to comply with section C.01.014.5; or
(b) the manufacturer to whom the number was assigned has been notified pursuant to section C.01.013 that the evidence he submitted in respect of the drug is insufficient.
C.01.014.7 Where a person who has been assigned a drug identification number for a drug discontinues sale of the drug in Canada, he shall, within 30 days of such discontinuation, inform the Director that he is no longer selling the drug.
Tablet Disintegration Times
C.01.015 (1) Subject to subsection (2), no person shall sell for human use a drug in the form of a tablet that is intended to be swallowed whole unless, when tested by the official method DO-25, Determination of the Disintegration Time of Tablets, dated July 5, 1989,
(a) in the case of an uncoated tablet, the tablet disintegrates in not more than 45 minutes;
(b) in the case of a plain coated tablet, the tablet disintegrates in not more than 60 minutes; and
(c) in the case where the label of the drug indicates that the tablet carries an enteric coating or a coating designed to serve a purpose similar to that of an enteric coating, the tablet does not disintegrate when exposed for 60 minutes to simulated gastric fluid, but when it is subsequently exposed for a continuous period to simulated intestinal fluid, the tablet disintegrates in not more than 60 minutes.
(2) Subsection (1) does not apply in respect of a drug in the form of a tablet where
(a) a notice of compliance in respect of the drug in the form of a tablet has been issued pursuant to section C.08.004;
(b) [Repealed, SOR/98-423, s. 7]
(c) a dissolution or disintegration test for the drug in the form of a tablet is prescribed in Division 6 of this Part;
(d) the drug is labelled as complying with a standard contained in a publication referred to in Schedule B to the Act;
(e) the drug has been demonstrated by an acceptable method to be available to the body; or
(f) representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug.
Adverse Drug Reaction Reporting
C.01.016 (1) No manufacturer shall sell a drug unless the manufacturer, with respect to any adverse drug reaction or any serious adverse drug reaction known to the manufacturer that occurs after this section comes into force, furnishes to the Director
(a) a report of all information in respect of any serious adverse drug reaction that has occurred in Canada with respect to the drug, within 15 days after receiving the information; and
(b) a report of all information in respect of any serious unexpected adverse drug reaction that has occurred outside Canada with respect to the drug, within 15 days after receiving the information.
(2) The manufacturer shall, on an annual basis and whenever requested to do so by the Director, conduct a concise, critical analysis of the adverse drug reactions and serious adverse drug reactions to a drug referred to in subsection (1) and prepare a summary report in respect of the reports received during the previous twelve months or received during such period of time as the Director may specify.
(3) Where, after reviewing any report furnished pursuant to subsection (1) and any available safety data relating to the drug, the Director considers that the drug may not be safe when used under the recommended conditions of use, the Director may, for the purpose of assessing the safety of the drug, request in writing, that the manufacturer submit
(a) case reports of all adverse drug reactions and serious adverse drug reactions to that drug that are known to the manufacturer; and
(b) a summary report prepared pursuant to subsection (2).
(4) The manufacturer shall submit the case reports and summary report referred to in subsection (3) within 30 days after receiving the request from the Director.
C.01.017 The manufacturer shall maintain records of the reports and case reports referred to in section C.01.016 for auditing purposes.
C.01.018 [Repealed, SOR/89-455, s. 3]
Limits of Drug Dosage
C.01.021 Except as provided in these Regulations, no person shall sell a drug for human use listed in the following table unless both the inner and the outer labels other than the inner label of a single dose container carry a statement of
(a) the quantitative content of the drug,
(b) the recommended single and daily adult dose designated as such, except for
(i) preparations solely for external use, or
(ii) preparations solely for children’s use; and
(c) adequate directions for use when the drug is recommended for children which shall be either
(i) the statement “CHILDREN: As directed by the physician”, or
(ii) a suitable reduced maximum single and daily dose which shall not exceed the following:
Age in yearsProportion of adult dose10 - 14one-half5 - 9one-fourth2 - 4one-sixthunder 2 yearsas directed by physicianTABLE
Table of Limits of Drug Dosage for Adults
ItemExternal UseInternal Use——Maximum LimitMaximum Dosage Unless otherwise stated, doses are in milligramsPer centSingleDailyAcetaminophen —6504.0 gAcetanilide and derivatives (except N-Acetyl-ρ-amino phenol) —65195Acetylsalicylic Acid —6504.0 gAconitine, its preparations and derivatives 0.20.10.1Adonis vernalis —65195Amylocaine, its salts and derivatives when sold or recommended for opthalmic use 0.00.00.0Amylocaine Hydrochloride, except when sold or recommended for ophthalmic use 1.00.00.0Antimony, compounds of —3.313Atropine, Methylatropine, and their salts 1.00.130.44Belladonna and its preparations, on the basis of belladonna alkaloids 0.3750.130.44Benzene (Benzol) ———Benzocaine 8.0195585Beta-Naphthol —195585Butacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.00.00.0Butacaine Sulphate, except when sold or recommended for opthalmic use 1.00.00.0Cadexomer Iodine 0.00.00.0Cantharides, cantharidin, and their preparations, on the basis of cantharidin, except blisters 0.030.00.0Cantharides, blisters only 0.20.00.0Cedar Oil 25.00.00.0Chlorbutol (not more often than every 4 hours) —325975Choline Salicylate —8705.22 gCinchocaine Hydrochloride, except suppositories 1.00.00.0Cinchocaine Hydrochloride, suppositories only —1111Colchicine and its salts —0.551.65Colchicum and its preparations, on the basis of colchicine —0.270.81Croton Oil 10.00.00.0Cyproheptadine and its salts — when sold or recommended for the promotion of weight gain—0.00.0Ephedrine and its salts —1132.5Ephedrine and its salts, sprays 1.0——Epinephrine and its salts, sprays 1.0——Gelseminine (Gelsemine) and its salts (not to be repeated within 4 hours) —0.551.65Gelsemium and its preparations, on the basis of the crude drug —16.248.6Hydrocyanic (Prussic) Acid as 2 per cent solution —0.062 ml0.31 mlHydroquinone 2.0——Hyoscine (Scopolamine) and its salts 0.50.3250.975Hyoscine aminoxide hydrobromide 0.50.3250.975Hyoscyamine and its salts —0.3250.975Hyoscyamus and its preparations, on the basis of hyoscyamus alkaloids —0.0730.22Lobelia and its preparations, on the basis of the crude drug —130390Lobeline and its salts —2.06.0Magnesium Salicylate —6504.0 gMethyl Salicylate 30——Methylene Blue —130390Phenacetin —6501.95 gPhenazone and compounds thereof —325975Phenol 2.032.5260Phenylpropanolamine when sold or recommended as an appetite depressent —0.00.0Phosphorus —0.00.0Podophyllin 0.00.00.0Potassium Chlorate —325975Potassium Chlorate, gargle 2.5——Procaine and its salts ———Proxymetacaine, its salts and derivatives when sold or recommended for ophthalmic use 0.00.00.0Salicylamide —9752.925 gSantonin —65130Selenium and its compounds 2.50.00.0Sodium Chlorate —325975Sodium Fluoride —0.10.1Sodium Salicylate —6504.0 gSquill and its preparations, on the basis of crude drug —32.597.5Stramonium and its preparations, on the basis of stramonium alkaloids —0.160.65Strychnine and its salts —0.00.0Tannic Acid —1501 000Tetracaine, its salts and derivatives when sold or recommended for ophthalmic use 0.00.00.0Thiocyanates 0.00.00.0Urethane 0.00.00.0Where drugs having similar physiological actions occur in combination, the dosage of each shall be proportionately reduced.
Accurate dosagesmay be expressed in either metric units or imperial units. If the dosage is expressed in both systems, then an approximation may be used for one expression, but such approximation must precede or follow the accurate statement by which the product will be judged and must be in brackets.
C.01.022 Notwithstanding paragraph C.01.021(b), the recommended single and daily dosage of a drug
(a) intended to be burned and the smoke inhaled may be increased to 10 times the oral dose, and
(b) intended for use as suppositories may be increased to 33 1/3 per cent in excess of the oral dose.
C.01.024 (1) Sections C.01.021 and C.01.022 do not apply to
(a) a drug sold to a drug manufacturer; or
(b) a drug sold on prescription.
(2) Paragraph C.01.021(c) does not apply to
(a) acetaminophen;
(b) acetylsalicylic acid;
(c) magnesium salicylate;
(d) sodium salicylate; or
(e) choline salicylate.
(3) Where a drug mentioned in any of paragraphs (2)(a) to (d) is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended
(a) that the drug be used as directed by a physician; or
(b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours.
TABLE
Maximum Dose
ItemColumn IColumn IIColumn IIIColumn IVColumn VColumn VIColumn VIIAgeMaximum Children’s Dose (80 mg units) Acetaminophen DropsMaximum Children’s Dose (80 mg units)Maximum Children’s Dose (160 mg units) AcetaminophenMaximum Adult’s Dose (325 mg units)Maximum Single Dose (mg)Maximum Daily Dose (mg)111 to under 12 years—631.54802 40029 to under 11 years—52.51.254002 00036 to under 9 years—4213201 60044 to under 6 years—31.5—2401 20052 to under 4 years—21—16080061 to under 2 years1.5 or as directed by a physician———12060074 months to under 1 year1 or as directed by a physician———8040080 to under 4 months0.5 or as directed by a physician———40200(4) Where choline salicylate is recommended for children, no person shall sell the drug for human use unless both the inner and the outer labels carry a statement that it is recommended
(a) that the drug be used as directed by physician; or
(b) that the maximum doses of the drug not exceed the amounts set out in the following table and that single doses not be administered more frequently than every four hours.
TABLE
MAXIMUM DOSEAge (Years)Adult Dosage Units (435 mg)Single Dose (mg)Maximum Daily Dose (mg)11 to under 121 ½6603 3009 to under 111 ¼5502 7506 to under 914402 2004 to under 6¾3301 6502 to under 4½2201 100Under 2As directed by physicianC.01.025 Both the inner and the outer labels of a drug that carry a recommended single or daily dosage or a statement of concentration in excess of the limits provided by section C.01.021 shall carry a caution that the product is to be used only on the advice of a physician.
C.01.026 The provisions of section C.01.025 do not apply to
(a) a drug sold on prescription, or
(b) the inner label of a single-dose container.
C.01.027 (1) Where a person advertises to the general public a drug for human use, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug if it
(a) contains a drug set out in the table to section C.01.021; and
(b) carries on its label
(i) a statement of the recommended single or daily adult dosage that results in a single or daily adult dosage of the drug referred to in paragraph (a) in excess of the maximum dosage set out in the table to section C.01.021 for that drug, or
(ii) a statement that shows a concentration of the drug referred to in paragraph (a) in excess of the maximum limit set out in the table to section C.01.021 for that drug.
(2) Subsection (1) does not apply to products containing
(a) acetaminophen;
(b) acetylsalicylic acid;
(c) choline salicylate;
(d) magnesium salicylate; or
(e) sodium salicylate.
(3) [Repealed, SOR/94-409, s. 1]
(4) Where a person advertises to the general public a drug for human use that contains acetylsalicylic acid, the person shall not make any representation with respect to its administration to or use by children or teenagers.
Cautionary Statements and Child Resistant Packages
C.01.028 (1) Subject to subsection (2), the inner and outer labels of a drug that contains
(a) acetylsalicylic acid or any of its salts or derivatives, salicylic acid or a salt thereof, or salicylamide, where the drug is recommended for children, shall carry a cautionary statement to the effect that the drug should not be administered to a child under two years of age except on the advice of a physician;
(b) boric acid or sodium borate as a medicinal ingredient shall carry a cautionary statement to the effect that the drug should not be administered to a child under three years of age;
(c) hyoscine (scopolamine) or a salt thereof shall carry a cautionary statement to the effect that the drug should not be used by persons suffering from glaucoma or where it causes blurring of the vision or pressure pain within the eye;
(d) phenacetin, either singly or in combination with other drugs, shall carry the following cautionary statement:
“CAUTION: May be injurious if taken in large doses or for a long time. Do not exceed the recommended dose without consulting a physician.”; or
(e) acetylsalicylic acid for internal use shall carry a cautionary statement to the effect that the drug should not be administered to or used by children or teenagers who have chicken pox or manifest flu symptoms before a physician or pharmacist is consulted about Reye’s syndrome, which statement shall also refer to the fact that Reye’s syndrome is a rare and serious illness.
(2) Subsection (1) does not apply to a drug that is
(a) intended for parenteral use only;
(b) dispensed pursuant to a prescription; or
(c) required to be sold on prescription pursuant to these Regulations or pursuant to the Narcotic Control Regulations.
C.01.029 (1) Subject to subsections C.01.031.2(1) and (2), the inner and outer labels of a drug
(a) that contains
(i) salicylic acid, a salt thereof or salicylamide,
(ii) acetylsalicylic acid, or any of its salts or derivatives,
(iii) acetaminophen, or
(iv) more than five per cent alkyl salicylates, or
(b) that is in a package that contains
(i) more than the equivalent of 250 mg of elemental iron, or
(ii) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices,
shall carry a cautionary statement to the effect that the drug should be kept out of the reach of children.
(2) Subject to subsections C.01.031.2(1) and (2), the inner and outer labels of a drug that is in a package that contains
(a) more than 1.5 g of salicylic acid or the equivalent quantity of any of its salts or salicylamide,
(b) more than 2 g of acetylsalicylic acid or the equivalent quantity of any of its salts or derivatives,
(c) more than 3.2 g of acetaminophen,
(d) more than the equivalent of 250 mg of elemental iron, or
(e) more than the equivalent of 120 mg of fluoride ion, unless the drug is intended solely for use in dentists’ offices,
shall carry a cautionary statement to the effect that there is enough drug in the package to seriously harm a child.
(3) The cautionary statements required under subsections (1) and (2) shall be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour.
C.01.030 [Repealed, SOR/2003-196, s. 104]
C.01.031 (1) Subject to section C.01.031.2,
(a) no person shall sell a drug described in subsection C.01.029(1) unless
(i) where the drug is recommended solely for children, it is packaged in a child resistant package, or
(ii) where the drug is not recommended solely for children, at least one of the sizes of packages available for sale is packaged in a child resistant package; and
(b) where a drug described in subsection C.01.029(1) is packaged in a package that is not a child resistant package, the outer label shall carry a statement that the drug is available in a child resistant package.
(2) [Repealed, SOR/93-468, s. 2]
C.01.031.1 [Repealed, SOR/87-484, s. 3]
C.01.031.2 (1) Sections C.01.029 to C.01.031 do not apply to a drug that is
(a) required by these Regulations or the Narcotic Control Regulations to be sold on prescription;
(b) intended for parenteral use only;
(c) in effervescent or powder form;
(d) in suppository form;
(e) intended for topical use, unless it is a liquid preparation containing more than five per cent alkyl salicylates;
(f) packaged in a non-reclosable package containing not more than two adult standard dosage units per package; or
(g) in toothpaste form.
(2) Sections C.01.029 to C.01.031 do not apply to a drug that is repackaged by a pharmacist or practitioner at the time of sale.
(3) Section C.01.031 does not apply to a drug that is
(a) sold only in containers that have roll-on or spray applicators or permanently installed wick applicators;
(b) sold for exclusive use in animals other than household pets; or
(c) intended solely for use in dentists’ offices, or packaged for hospital use only.
C.01.032 No person shall sell a corticosteroid drug for ophthalmic use unless
(a) the outer label or the package insert carries, as part of the directions for use, the following statements:
“Contraindications
Viral diseases of the cornea and conjunctiva;
Tuberculosis of the eye;
Fungal diseases of the eye;
Acute purulent untreated infections of the eye, which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid.
Side Effects
Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur.”;
and
(b) the inner label carries the statements required by paragraph (a) or instructions to see the outer label or package insert for information about contraindications and side effects.
C.01.033 Section C.01.032 does not apply to a corticosteroid drug that is dispensed by a registered pharmacist pursuant to a prescription.
C.01.034 No person shall disseminate to a practitioner promotional literature about corticosteroid drugs for ophthalmic use unless the statements required by paragraph C.01.032(a) are included in that literature.
C.01.035 Sections C.01.032 and C.01.034 do not apply to a drug sold solely for veterinary use.
Miscellaneous
C.01.036 (1) No manufacturer or importer shall sell
(a) a drug that contains phenacetin in combination with any salt or derivative of salicylic acid;
(b) a drug for human use that contains
(i) oxyphenisatin,
(ii) oxyphenisatin acetate, or
(iii) phenisatin; or
(c) a drug for human use that contains mercury or a salt or derivative thereof, unless the drug is
(i) a drug described in Schedule C or D to the Act, or
(ii) one of the following drugs, namely,
(A) an ophthalmic drug or other drug to be used in the area of the eye,
(B) a drug for nasal administration,
(C) a drug for otic administration, or
(D) a drug for parenteral administration that is packaged in a multi-dose container,
in which the mercury or the salt or derivative thereof is present as a preservative and the manufacturer or importer has submitted evidence to the Director demonstrating that the only satisfactory way to maintain the sterility or stability of the drug is to use that preservative.
(2) For the purpose of clause (1)(c)(ii)(A), area of the eye means the area bounded by the supraorbital and infraorbital ridges and includes the eyebrows, the skin underlying the eyebrows, the eyelids, the eyelashes, the conjunctival sac of the eye, the eyeball and the soft tissue that lies below the eye and within the infraorbital ridge.
C.01.036.1 No person shall sell, or advertise for sale, nitrous oxide to the general public.
C.01.037 (1) No person shall sell to the general public a drug that is recommended solely for children if the package in which the drug is sold contains
(a) more than 1.92 g of salicylamide or salicylic acid or the equivalent quantity of a salt of salicylic acid;
(b) more than 1.92 g of acetylsalicylic acid or the equivalent quantity of a salt or derivative thereof;
(c) more than 3.2 g of acetaminophen in 160 mg dosage units; or
(d) more than 1.92 g of acetaminophen in 80 mg dosage units.
(2) Subsection (1) does not apply to a drug dispensed pursuant to a prescription.
C.01.038 A drug for human use is adulterated if it contains
(a) Strychnine or any of its salts;
(b) extracts or tinctures of
(i) Strychnos nux vomica,
(ii) Strychnos Ignatii, or
(iii) a Strychnos species containing strychnine, other than those species mentioned in subparagraphs (i) and (ii);
(c) Methapyrilene or any of its salts;
(d) Echimidine or any of its salts; or
(e) any of the following plant species or extracts or tinctures thereof:
(i) Symphytum asperum,
(ii) Symphytum x uplandicum, or
(iii) any other plant species containing echimidine.
C.01.039 In vitro diagnostic products that are or contain drugs other than drugs listed in Schedule E to the Act, and drugs listed in Schedule D to the Act that are labelled for veterinary use only, are exempt from the application of this Part.
C.01.040 No manufacturer or importer shall sell a drug for human use that contains as an ingredient
(a) chloroform; or
(b) arsenic or any of its salts or derivatives.
C.01.040.1 No manufacturer shall use methyl salicylate as a medicinal ingredient in a drug for internal use in humans.
Colouring Agents
C.01.040.2 (1) No manufacturer shall use a colouring agent in a drug other than a colouring agent listed in subsections (3) and (4).
(2) No person shall import for sale a drug that contains a colouring agent other than a colouring agent listed in subsections (3) and (4).
(2.1) In subsections (3) and (4),
C.I. (indication of the number)
C.I. (indication of the number) means the designation used to identify a colouring agent in the Colour Index published by The Society of Dyers and Colourists, as amended from time to time; (C.I. (indication du numéro))
D & C (indication of the colour and the number)
D & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in drugs and cosmetics; (D&C (indication de la couleur et du numéro))
FD & C (indication of the colour and the number)
FD & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in food, drugs and cosmetics. (FD&C (indication de la couleur et du numéro))
(3) The following colouring agents are permitted in drugs for internal and external use, namely,
(a) ACID FUCHSIN D (D & C Red No. 33; C.I. No. 17200),
ALIZARIN CYANINE GREEN F (D & C Green No. 5; C.I. No. 61570),
ALLURA RED AC (FD & C Red No. 40; C.I. No. 16035),
AMARANTH (Delisted FD & C Red No. 2; C.I. No. 16185),
ANTHOCYANIN DERIVED FROM JUICE EXPRESSED FROM FRESH EDIBLE FRUITS OR VEGETABLES,
ß-APO-81-CAROTENAL (C.I. No. 40820),
BRILLIANT BLUE FCF SODIUM SALT (FD & C Blue No. 1; C.I. No. 42090),
BRILLIANT BLUE FCF AMMONIUM SALT (D & C Blue No. 4; C.I. No. 42090),
CANTHAXANTHIN (C.I. No. 40850),
CARAMEL,
CARBON BLACK (C.I. No. 77266),
CARMINE (C.I. No. 75470),
CARMOISINE (Delisted Ext. D & C Red No. 10; C.I. No. 14720),
ß-CAROTENE (C.I. No. 40800),
CHLOROPHYLL (C.I. No. 75810),
EOSIN YS ACID FORM (D & C Red No. 21; C.I. No. 45380:2),
EOSIN YS SODIUM SALT (D & C Red No. 22; C.I. No. 45380),
ERYTHROSINE (FD & C Red No. 3; C.I. No. 45430),
FAST GREEN FCF (FD & C Green No. 3; C.I. No. 42053),
FLAMING RED (D & C Red No. 36; C.I. No. 12085),
HELINDONE PINK CN (D & C Red No. 30; C.I. No. 73360),
INDIGO (D & C Blue No. 6; C.I. No. 73000),
INDIGOTINE (FD & C Blue No. 2; C.I. No. 73015),
IRON OXIDES (C.I. Nos . 77489, 77491, 77492, 77499),
LITHOL RUBIN B SODIUM SALT (D & C Red No. 6; C.I. No. 15850),
LITHOL RUBIN B CALCIUM SALT (D & C Red No. 7; C.I. No. 15850:1),
PHLOXINE B ACID FORM (D & C Red No. 27; C.I. No. 45410:1),
PHLOXINE B SODIUM SALT (D & C Red No. 28; C.I. No. 45410),
PONCEAU 4R (C.I. No. 16255),
PONCEAU SX (FD & C Red No. 4; C.I. No. 14700),
QUINOLINE YELLOW WS (D & C Yellow No. 10; C.I. No. 47005),
RIBOFLAVIN,
SUNSET YELLOW FCF (FD & C Yellow No. 6; C.I. No. 15985),
TARTRAZINE (FD & C Yellow No. 5; C.I. No. 19140),
TITANIUM DIOXIDE (C.I. No. 77891);
(b) preparations made by extending any of the colouring agents listed in paragraph (a) on a substratum of
(i) alumina,
(ii) blanc fixe,
(iii) gloss white,
(iv) clay,
(v) zinc oxide,
(vi) talc,
(vii) rosin,
(viii) aluminum benzoate,
(ix) calcium carbonate, or
(x) any combination of the substances listed in subparagraphs (i) to (ix); and
(c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of
(i) alumina,
(ii) blanc fixe,
(iii) gloss white,
(iv) clay,
(v) zinc oxide,
(vi) talc,
(vii) rosin,
(viii) aluminum benzoate,
(ix) calcium carbonate, or
(x) any combination of the substances listed in subparagraphs (i) to (ix).
(4) The following colouring agents are permitted in drugs for external use, namely,
(a) ACID VIOLET 43 (Ext. D & C Violet No. 2; C.I. No. 60730),
ALIZUROL PURPLE SS (D&C Violet No. 2; C.I. No. 60725),
ANNATTO (C.I. No. 75120),
BISMUTH OXYCHLORIDE (C.I. No. 77163),
CHROMIUM HYDROXIDE GREEN (PIGMENT GREEN 18 (C.I. No. 77289)),
DEEP MAROON (D&C Red No. 34; C.I. No. 15880:1),
DIBROMOFLUORESCEIN (SOLVENT RED 72 (C.I. No. 45370:1); ORANGE No. 5 (D & C Orange No. 5)),
FERRIC FERROCYANIDE (C.I. No. 77510),
GUANINE (C.I. No. 75170),
MANGANESE VIOLET (C.I. No. 77742),
MICA (C.I. No. 77019),
ORANGE II (D&C Orange No. 4; C.I. No. 15510),
PYRANINE CONCENTRATED (D&C Green No. 8; C.I. No. 59040),
QUINIZARIN GREEN SS (D&C Green No. 6; C.I. No. 61565),
TONEY RED (D&C Red No. 17; C.I. No. 26100),
URANINE ACID FORM (D&C Yellow No. 7; C.I. No. 45350:1),
URANINE SODIUM SALT (D&C Yellow No. 8; C.I. No. 45350);
ZINC OXIDE (C.I. No. 77947);
(b) preparations made by extending any of the colouring agents listed in paragraph (a) on a substratum of
(i) alumina,
(ii) blanc fixe,
(iii) gloss white,
(iv) clay,
(v) zinc oxide,
(vi) talc,
(vii) rosin,
(viii) aluminum benzoate,
(ix) calcium carbonate, or
(x) any combination of the substances listed in subparagraphs (i) to (ix); and
(c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of
(i) alumina,
(ii) blanc fixe,
(iii) gloss white,
(iv) clay,
(v) zinc oxide,
(vi) talc,
(vii) rosin,
(viii) aluminum benzoate,
(ix) calcium carbonate, or
(x) any combination of the substances listed in subparagraphs (i) to (ix).
(5) Subsections (1) and (2) do not apply in respect of a drug that is represented as being solely for use in the disinfection, for disease prevention, of
(a) medical devices;
(b) health care facilities; or
(c) premises in which food is manufactured, prepared or kept.
Schedule F Drugs
C.01.041 (1) In this section and sections C.01.041.1 to C.01.046, Schedule F Drug means a drug listed or described in Schedule F to these Regulations.
(1.1) Subject to sections C.01.043 and C.01.046, no person shall sell a substance containing a Schedule F Drug unless
(a) the sale is made pursuant to a verbal or written prescription received by the seller; and
(b) where the prescription has been transferred to the seller under section C.01.041.1, the requirements of section C.01.041.2 have been complied with.
(2) Where the prescription for a Schedule F Drug is written, the person selling the drug shall retain the prescription for at least two years from the date of filling.
(3) Where the prescription for a Schedule F Drug is verbal, the person to whom the prescription is communicated by the practitioner shall forthwith reduce the prescription to writing and the person selling the drug shall retain that written prescription for a period of at least two years from the date of filling.
(4) The person reducing a verbal prescription to writing shall indicate on the written prescription
(a) the date and number of the prescription;
(b) the name and address of the person for whose benefit the prescription is given;
(c) the proper name, common name or brand name of the specified drug and the quantity thereof;
(d) his name and the name of the practitioner who issued the prescription; and
(e) the directions for use given with the prescription, including whether or not the practitioner authorized the refilling of the prescription and, if the prescription is to be refilled, the number of times it may be refilled.
(5) Subsections (1.1) to (4) do not apply to a substance containing
(a) chloral hydrate in preparations for external use, where it constitutes not more than one per cent of the substance, or
(b) hexachlorophene and its salts, where it constitutes not more than 0.75 per cent of the substance, calculated as hexachlorophene.
C.01.041.1 A pharmacist may transfer to another pharmacist a prescription for a Schedule F Drug.
C.01.041.2 A pharmacist to whom a prescription has been transferred under section C.01.041.1 shall not sell a drug pursuant thereto until
(a) he has obtained from the pharmacist transferring the prescription his name and address, the number of authorized refills remaining and the date of the last refill; and
(b) he has
(i) received a copy of the prescription as written by the practitioner or as reduced to writing as required by subsections C.01.041(3) and (4), as the case may be, or
(ii) where the prescription has been transferred to him verbally, reduced the prescription to writing indicating therein the information specified in subsection C.01.041(4).
C.01.041.3 The pharmacist to whom a prescription for a Schedule F Drug is transferred under section C.01.041.1 shall retain in his files for a period of two years the information and documents referred to in section C.01.041.2.
C.01.041.4 A pharmacist who transfers a prescription under section C.01.041.1
(a) shall enter on the original of the prescription or in a suitable record of prescription kept under the name of each patient, the date of transfer; and
(b) shall not make any further sales under the prescription nor transfer it to another pharmacist.
C.01.042 (1) No person shall refill a prescription for a Schedule F Drug unless the practitioner so directs and no person shall refill such a prescription more times than the number of times prescribed by the practitioner.
(2) The person filling or refilling a prescription for a Schedule F Drug shall enter on the original of the prescription or in a suitable record of prescriptions kept under the name of each patient
(a) the date of filling;
(b) the date of each refill, if applicable;
(c) the quantity of drug dispensed at the original filling and each refill; and
(d) his name.
C.01.043 (1) A person may sell a Schedule F Drug, without having received a prescription therefor, to
(a) a drug manufacturer;
(b) a practitioner;
(c) a wholesale druggist;
(d) a registered pharmacist;
(e) a hospital certified by the Department of National Health and Welfare;
(f) a Department of the Government of Canada or of a province, upon receipt of a written order signed by the Minister thereof or his duly authorized representative; or
(g) any person, upon receipt of a written order signed by the Director.
(2) Where a person makes a sale authorized by paragraph (1)(f) or (1)(g), he shall retain the written order for the drug for a period of at least two years from the date of filling the order.
C.01.044 (1) Where a person advertises to the general public a Schedule F Drug, the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug.
(2) Subsection (1) does not apply where
(a) the drug is listed in Part II of Schedule F; and
(b) the drug is
(i) in a form not suitable for human use, or
(ii) labelled in the manner prescribed by paragraph C.01.046(b).
C.01.045 (1) Subject to subsection (2), no person other than
(a) a practitioner,
(b) a drug manufacturer,
(c) a wholesale druggist,
(d) a registered pharmacist, or
(e) a resident of a foreign country while a visitor in Canada,
shall import a Schedule F Drug.
(2) Any person may import a Schedule F Drug listed in Part II of Schedule F if the drug is imported in such form or so labelled that it could be sold by that person pursuant to section C.01.046.
C.01.046 A person may sell a drug listed or described in Part II of Schedule F to the Regulations, without having received a prescription therefor, if
(a) the drug is in a form not suitable for human use; or
(b) the principal display panel of both the inner label and the outer label carries, in both official languages, the statement “For Veterinary Use Only / Pour usage vétérinaire seulement” or “Veterinary Use Only / Usage vétérinaire seulement”, immediately following or preceding the brand name, proper name or common name, in type size not less than one-half as large as the largest type on the label.
C.01.047 [Repealed, SOR/80-543, s. 4]
C.01.048 (1) Where a person who is a physician, dentist, veterinary surgeon or pharmacist registered and entitled to practise that person’s profession in a province has signed an order specifying the brand name, proper name or common name and the quantity of a drug, other than
(a) a narcotic as defined in the Narcotic Control Regulations,
(b) a controlled drug as defined in subsection G.01.001(1), or
(c) a new drug in respect of which a notice of compliance has not been issued under section C.08.004,
the person who receives the order may distribute the drug to the physician, dentist, veterinary surgeon or pharmacist as a sample if the drug is labelled in accordance with these Regulations.
(2) An order referred to in subsection (1) may provide that the order be repeated at specified intervals during any period not exceeding six months.
C.01.049 A person who, under section C.01.048, distributes a drug as a sample shall
(a) maintain records showing
(i) the name, address and description of each person to whom the drug is distributed,
(ii) the brand name, quantity and form of the drug distributed, and
(iii) the date upon which each such distribution was made; and
(b) keep those records and all orders received for drugs in accordance with section C.01.048 for a period of not less than two years from the date upon which the distribution referred to in the records was made.
Recalls
C.01.051 Where a manufacturer who sells a drug in dosage form or a person who imports into and sells in Canada a drug in dosage form commences a recall of the drug, the manufacturer or importer shall forthwith submit to the Director the following information:
(a) the proper name of the drug, the common name of the drug if there is no proper name, the brand name of the drug and the lot number;
(b) in the case of an imported drug, the names of the manufacturer and importer;
(c) the quantity of the drug manufactured or imported;
(d) the quantity of the drug distributed;
(e) the quantity of the drug remaining on the premises of the manufacturer or importer;
(f) the reasons for initiating the recall; and
(g) a description of any other action taken by the manufacturer or importer with respect to the recall.
C.01.052 [Repealed, SOR/82-524, s. 2]
C.01.055 and C.01.056 [Repealed, SOR/82-524, s. 2]
Limits of Variability
C.01.061 (1) Where the net amount of a drug in a package is not expressed on the label in terms of number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain an amount of the drug such that, when determined by that official method, the average of the net amounts of the drug in the 10 packages is not less than the net amount of the drug shown on the label.
(2) Where the net amount of a drug in a package is expressed on the label in terms of the number of dosage units, any 10 packages of the drug selected as provided by official method DO-31, Determination of Net Contents, dated December 7, 1988, shall contain a number of units such that, when determined by that official method,
(a) the average number of dosage units in the 10 packages is not less than the number of dosage units shown on the label;
(b) no package contains less than the number of dosage units shown on the label except as provided in the table; and
(c) where the drug is a controlled drug as defined in subsection G.01.001(1) or a narcotic as defined in the Narcotic Control Regulations, no package contains more than the number of dosage units shown on the label except as provided in the table to this section.
TABLE
ItemColumn IColumn IILabelled Number of Dosage Units Per PackagePermitted Variation from the Labelled Number150 or less02More than 50, but less than 10113101 or morethe greater of one unit or 0.75% of the labelled number, rounded up to the next whole numberC.01.062 (1) Subject to subsections (2) to (5), no manufacturer shall sell a drug in dosage form where the amount of any medicinal ingredient therein, determined using an acceptable method, is
(a) less than 90.0 per cent of the amount of the medicinal ingredient shown on the label; or
(b) more than 110.0 per cent of the amount of the medicinal ingredient shown on the label.
(2) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a volatile substance of botanical origin or its synthetic equivalent, the amount of that ingredient, determined using an acceptable method, shall be
(a) not less than 85.0 per cent of the amount of the medicinal ingredient shown on the label; and
(b) not more than 120.0 per cent of the amount of the medicinal ingredient shown on the label.
(3) Subject to subsection (5), where a drug in capsule form contains a medicinal ingredient that is a vitamin in a fish-liver oil, no variation from the amount of the medicinal ingredient as shown on the label, determined using an acceptable method, is permitted other than that which is in accordance with the variation for that fish-liver oil as stated in any publication whose name is referred to in Schedule B to the Act.
(4) Subject to subsection (5), where a drug in dosage form contains a medicinal ingredient that is a vitamin, no variation from the amount of the medicinal ingredient shown on the label, determined using an acceptable method, is permitted other than the variation set out in column III or IV of an item of the table to this section opposite the vitamin set out in column I of that item for the amount of vitamin set out in column II of that item.
(5) Subsections (1) to (4) do not apply in respect of
(a) a drug for which a notice of compliance has been issued pursuant to section C.08.004;
(b) [Repealed, SOR/98-423, s. 8]
(c) a drug for which a standard is contained in any publication whose name is referred to in Schedule B to the Act;
(d) a drug described in Schedule C or D to the Act or Division 6 of Part C of these Regulations; or
(e) a drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and in respect of which
(i) the conditions of pharmaceutical production and quality control are suitable for controlling the identity, quality, purity, stability, safety, strength and potency of the drug,
(ii) all labels, package inserts, product brochures and file cards to be used in connection with the drug make proper claims in respect of the drug,
(iii) the drug can, without undue foreseeable risk to humans, be used for the purposes and under the conditions of use recommended by the manufacturer, and
(iv) the drug is effective for the purposes and under the conditions of use recommended by the manufacturer.
TABLE
Column IColumn IIColumn IIIColumn IVItemVitaminRecommended daily doseLimits of variation when the recommended daily dose shown on label is equal to or less then amount set out in column IILimits of variation when the recommended daily dose shown on label is greater than amount set out in column II1vitamin A (or as B-carotene)10 000 I.U.90.0 - 165.0 %90.0 - 115.0 %2thiamine4.5 mg90.0 - 145.0 %90.0 - 125.0 %3riboflavin7.5 mg90.0 - 125.0 %90.0 - 125.0 %4niacin or niacinamide45 mg90.0 - 125.0 %90.0 - 125.0 %5pyridoxine3 mg90.0 - 125.0 %90.0 - 125.0 %6d-pantothenic acid15 mg90.0 - 135.0 %90.0 - 125.0 %7folic acid0.4 mg90.0 - 135.0 %90.0 - 115.0 %8vitamin B1214 µg90.0 - 135.0 %90.0 - 125.0 %9vitamin C150 I.U.90.0 - 145.0 %90.0 - 125.0 %10vitamin D400 I.U.90.0 - 145.0 %90.0 - 115.0 %11vitamin E25 I.U.90.0 - 125.0 %90.0 - 125.0 %12vitamin K0.0 mg90.0 - 115.0 %13biotin0.0 mg90.0 - 135.0 %C.01.063 [Repealed, SOR/96-399, s. 2]
C.01.064 Where a drug is prepared for ophthalmic or parenteral use and contains a preservative ingredient, that ingredient
(a) shall be present only in an amount necessary to obtain the intended action and that does not pose undue risk to humans or animals; and
(b) shall not interfere with the therapeutic properties of the drug.
C.01.065 No person shall sell a drug that is prepared for ophthalmic or parenteral use unless a representative sample of each lot of the drug in its immediate container
(a) is tested by an acceptable method for identity, and the drug is found to be true to its proper name, or to its common name if there is no proper name;
(b) is tested by an acceptable method for sterility, except
(i) for living vaccines, or
(ii) where the manufacturer has submitted evidence, satisfactory to the Director to prove that processing controls ensure the sterility of the drug in its immediate container,
and the drug is found to be sterile; and
(c) is subjected to such further tests satisfactory to the Director to ensure that the drug is safe to use according to directions.
C.01.066 No person shall sell a drug in aqueous solution that is prepared for parenteral use unless it has been prepared with non-pyrogenic water produced by distillation or reverse osmosis.
C.01.067 (1) Subject to subsection (2), no person shall sell a drug that is prepared for parenteral use unless a representative sample of each lot of the drug in its immediate container
(a) is tested by an acceptable method for the presence of pyrogens; and
(b) when so tested, is found to be non-pyrogenic.
(2) Subsection (1) does not apply in respect of a drug that cannot be tested for the presence of pyrogens or that is inherently pyrogenic.
C.01.068 Detailed records of the tests required by sections C.01.065 and C.01.067 shall be retained by the manufacturer for a period of at least one year after the expiration date on the label of the drug.
C.01.069 The packaging of a drug that is prepared for parenteral use shall meet the following requirements:
(a) the immediate container shall be of such material and construction that
(i) no deleterious substance is yielded to the drug,
(ii) it is non-reactive with the drug,
(iii) visual or electronic inspection of the drug is possible,
(iv) protection against environmental factors that cause deterioration or contamination of the drug is provided or, where that protection cannot be provided by the immediate container, it is provided by the secondary packaging, and
(v) a sufficient quantity of the drug is contained to allow withdrawal of the labelled amount of the drug; and
(b) the immediate closures and any material coming into contact with the drug in its immediate container shall meet the requirements of subparagraphs (a)(i) and (ii).
C.01.070 No person shall sell a drug that is a hypodermic tablet that does not completely dissolve in and form a clear solution with water.
Mercuric Chloride Tablets
C.01.071 No person shall sell mercuric chloride tablets for household use that are packaged in lots of 200 or less, unless
(a) such tablets are
(i) of an irregular or angular shape,
(ii) coloured blue, and
(iii) packed in an immediate container that is readily distinguishable by touch; and
(b) the principal display panel of both the inner and the outer labels carries in prominent type and in a colour contrasting to that of such labels
(i) the design of a skull and cross-bones, and
(ii) the word “Poison”.
C.01.081 [Repealed, SOR/80-544, s. 4]
C.01.085 [Repealed, SOR/80-544, s. 5]
Synthetic Sweeteners
C.01.121 and C.01.122 [Repealed, SOR/80-544, s. 6]
Aminopyrine and Dipyrone
C.01.131 No person shall sell Aminopyrine or Dipyrone (a derivative of Aminopyrine) for oral or parenteral use, unless
(a) the inner label carries the statement:
“WARNING: Fatal agranulocytosis may be associated with the use of Aminopyrine and Dipyrone. It is essential that adequate blood studies be made. (See enclosed warnings and precautions)”; and
(b) the outer label or the package insert carries the following statements:
“WARNING: Serious and even fatal agranulocytosis is known to occur after the administration of Aminopyrine or Dipyrone. Fatal agranulocytosis has occurred after short term, intermittent and prolonged therapy with the drugs. Therefore, the use of these drugs should be as brief as possible. Bearing in mind the possibility that such reactions may occur, Aminopyrine or Dipyrone should be used only when other less potentially dangerous agents are ineffective.
PRECAUTIONS: It is essential that frequent white blood cell counts and differential counts be made during treatment with these drugs. However, it is emphasized that agranulocytosis may occur suddenly without prior warning. The drug should be discontinued at the first evidence of any alteration of the blood count or sign of agranulocytosis, and the patient should be instructed to discontinue use of the drug at the first indication of sore throat or sign of other infection in the mouth or throat (pain, swelling, tenderness, ulceration).”
C.01.132 No person shall disseminate to a practitioner promotional literature about Aminopyrine or Dipyrone unless the statements set out in section C.01.131 are included in such literature.
C.01.133 The provisions of sections C.01.131 and C.01.132 do not apply to preparations containing Aminopyrine or Dipyrone that are
(a) dispensed by a pharmacist pursuant to a prescription; or
(b) sold for veterinary use only.
Coated Potassium Salts
C.01.134 No person shall sell coated tablets containing potassium salts, with or without thiazide diuretics, unless the inner label thereof or the package insert carries the following statement:
“WARNING: A probable association exists between the use of coated tablets containing potassium salts, with or without thiazide diuretics, and the incidence of serious small bowel ulceration. Such preparations should be used only when adequate dietary supplementation is not practical, and should be discontinued if abdominal pain, distension, nausea, vomiting or gastro-intestinal bleeding occur.”
C.01.135 No person shall disseminate to a practitioner promotional literature about coated tablets containing potassium salts, with or without thiazide diuretics, unless the statement set out in section C.01.134 is included in such literature.
C.01.136 The provisions of sections C.01.134 and C.01.135 do not apply to coated tablets containing potassium salts with or without thiazide diuretics that
(a) are sold for veterinary use only;
(b) are dispensed by a pharmacist pursuant to a prescription; or
(c) contain 100 milligrams or less of elemental potassium per tablet.
Antibiotics
C.01.401 Except as provided in these Regulations, an antibiotic for other than parenteral use shall, in addition to meeting the requirements of section C.01.004, carry on both the inner label and outer label the potency of the drug, expressed in terms of International Units where established or, if no International Unit has been established, in terms of units, milligrams, micrograms or fractions of a gram,
(a) per gram in the case of solids or viscous liquids;
(b) per millilitre in the case of other liquids; and
(c) per individual dosage or dispensing form in the case of antibiotic preparations put up in individual dosage or dispensing form.
C.01.402 [Repealed, SOR/92-654, s. 4]
C.01.410 to C.01.412 [Repealed, SOR/80-544, s. 8]
C.01.420 to C.01.422 [Repealed, SOR/80-544, s. 8]
Chloramphenicol
C.01.430 to C.01.432 [Repealed, SOR/80-544, s. 8]
C.01.433 No person shall sell chloramphenicol and its salts and derivatives, for oral or parenteral use, unless
(a) the inner label carries a warning statement to the effect that
(i) bone marrow depression has been associated with the use of chloramphenicol, and
(ii) the enclosed warnings and precautions should be read carefully; and
(b) the outer label or the package insert carries the following:
(i) a warning statement to the effect that chloramphenicol should not be used in the treatment or prophylaxis of minor infections or where it is not indicated, as in cold, influenza, or infections of the upper respiratory tract; that there are two types of bone marrow depression associated with the use of chloramphenicol; that some degree of depression of the bone marrow is commonly seen during therapy, is dose-related and is potentially reversible; that blood studies may detect early changes and; that the other type of bone marrow depression, a sudden, delayed and usually fatal bone marrow hypoplasia that may occur without warning, is very rare, and
(ii) a statement of precautions to be taken to the effect that it is essential that appropriate blood studies be made during treatment with chloramphenicol and that while blood studies may detect early peripheral blood changes, such studies cannot be relied on to detect the rare and generally irreversible bone marrow depression prior to development of aplastic anemia.
C.01.434 The provisions of section C.01.433 do not apply to chloramphenicol and its salts or derivatives sold by a registered pharmacist.
C.01.435 No person shall disseminate to a practitioner promotional literature about chloramphenicol and its salts or derivatives for oral or parenteral use unless the statements set out in paragraph C.01.433(b) are included in such literature.
C.01.436 The provisions of sections C.01.433 and C.01.435 do not apply to a drug sold solely for veterinary use.
C.01.440 to C.01.442 [Repealed, SOR/80-544, s. 8]
C.01.450 to C.01.452 [Repealed, SOR/80-544, s. 8]
C.01.460 to C.01.462 [Repealed, SOR/80-544, s. 8]
C.01.470 to C.01.472 [Repealed, SOR/80-544, s. 8]
C.01.480 [Repealed, SOR/80-544, s. 8]
C.01.490 to C.01.497 [Repealed, SOR/80-544, s. 8]
C.01.510 to C.01.513 [Repealed, SOR/80-544, s. 8]
C.01.520 to C.01.522 [Repealed, SOR/80-544, s. 8]
C.01.530 to C.01.532 [Repealed, SOR/80-544, s. 8]
C.01.540 to C.01.542 [Repealed, SOR/80-544, s. 8]
C.01.550 to C.01.552 [Repealed, SOR/80-544, s. 8]
C.01.560 to C.01.563 [Repealed, SOR/80-544, s. 8]
C.01.570 to C.01.572 [Repealed, SOR/80-544, s. 8]
C.01.580 [Repealed, SOR/80-544, s. 8]
C.01.590 to C.01.592 [Repealed, SOR/80-544, s. 8]
Veterinary Drugs
C.01.600 No person shall sell for veterinary use a drug listed in the Table of Limits of Drug Dosage for Adults, other than a drug in a form not suitable for human use, unless both the inner and outer labels carry the statement “For Veterinary Use Only” or “Veterinary Use Only”.
C.01.601 [Repealed, SOR/93-407, s. 6]
C.01.602 The provisions of sections C.01.401 and C.01.402 do not apply to an antibiotic in amounts less than 50 parts per million contained in an animal food.
C.01.603 The provisions of paragraphs C.01.401 (b) and (c) and section C.01.402 do not apply to an antibiotic in amounts greater than 50 parts per million contained in an animal food.
C.01.604 Both the inner and outer labels of a veterinary drug represented as containing a vitamin shall carry
(a) a statement of the amount of each vitamin present in the drug, expressed in terms of the proper name only of the vitamin in
(i) International Units per gram or per millilitre for vitamin A, provitamin A, vitamin D, and vitamin E,
(ii) milligrams per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for thiamine, riboflavin, niacin, niacinamide, pyridoxine, d-pantothenic acid, d-panthenol, folic acid, ascorbic acid, and vitamin K,
(iii) micrograms per gram in the case of solids or viscous liquids, or per millilitre in the case of other liquids, for biotin, and vitamin B12,
(iv) Oral Units for vitamin B12 with intrinsic factor concentrate, or
(v) for vitamin products put up in individual dosage or dispensing form, the specified units per individual dosage or dispensing form;
(b) except for drugs in a form not suitable for human use, the statement “For Veterinary Use Only” or “Veterinary Use Only”.
C.01.605 An antibiotic for parenteral use that is recommended for veterinary use only shall carry on both the inner and outer labels
(a) the potency of the drug expressed in terms of International Units where established, or, if no International Unit has been established, in terms of units, milligrams or fractions of a gram, per gram in the case of solids or viscous liquids, per millilitre in the case of other liquids, or per individual dosage or dispensing form for antibiotic preparations put up in individual dosage or dispensing form; and
(b) [Repealed, SOR/92-654, s. 5]
(c) the statement “For Veterinary Use Only” or “Veterinary Use Only”.
C.01.606 No person shall sell an antibiotic preparation for the treatment of animals, other than an antibiotic preparation that is a new drug sold pursuant to section C.08.013, unless,
(a) where the preparation is not to be used for lactating animals providing milk to be consumed as food, the inner and outer labels of the preparation carry a statement to that effect; or
(b) where the preparation may be used for lactating animals providing milk to be consumed as food,
(i) there has been submitted, on request, to the Director, acceptable evidence to show the period of time, not exceeding 96 hours, that must elapse after the last treatment with the preparation in order that the milk from treated lactating animals will contain no residue of antibiotics that would cause injury to human health, and
(ii) the principal display panel of the outer label of the preparation, the inner label and the packaging insert, if any, describing the antibiotic preparation carry the warning “WARNING: MILK TAKEN FROM TREATED ANIMALS DURING TREATMENT AND WITHIN ... HOURS AFTER THE LATEST TREATMENT MUST NOT BE USED AS FOOD”, where the number of hours to be inserted is determined according to evidence submitted pursuant to subparagraph (i).
C.01.606.1 No person shall sell a product intended for the prevention or treatment of foot rot of cattle if that product contains Ethylenediamine Dihydroiodide (EDDI).
C.01.607 Notwithstanding subparagraph C.01.004(1)(c)(ii), the declaration of a lot number is not required on the label of an animal feeding-stuff containing a drug.
C.01.608 The provisions of section C.01.604 do not apply to medicated feeds registered under the Feeds Act.
C.01.609 Notwithstanding the provisions of section C.01.401(a), the potency of an antibiotic in in amounts greater than 50 parts per million contained in a medicated feed registered under the Feeds Act may be declared in grams per ton.
C.01.610 No person shall sell any substance having oestrogenic activity for administration to poultry that may be consumed as food.
C.01.610.1 No person shall sell a drug for administration to animals that produce food or that are intended for consumption as food if that drug contains
(a) chloramphenicol or its salts or derivatives;
(b) a 5-nitrofuran compound;
(c) clenbuterol or its salts or derivatives;
(d) a 5-nitroimidazole compound; or
(e) diethylstilbestrol or other stilbene compounds.
C.01.610.2 No person shall sell an antibiotic preparation containing chloramphenicol, its salts or derivatives, for administration to animals that do not produce food and that are not intended for consumption as food unless
(a) both the inner label and outer label of the preparation carry the words “WARNING: FEDERAL LAW PROHIBITS THE ADMINISTRATION OF THIS PREPARATION TO ANIMALS THAT PRODUCE FOOD OR ANIMALS THAT ARE INTENDED FOR CONSUMPTION AS FOOD / MISE EN GARDE : EN VERTU DES LOIS FÉDÉRALES, IL EST INTERDIT D’ADMINISTRER CETTE PRÉPARATION AUX ANIMAUX QUI PRODUISENT DES ALIMENTS OU AUX ANIMAUX DESTINÉS À ÊTRE CONSOMMÉS COMME ALIMENTS”;
(b) where the preparation is for parenteral use, the preparation contains, in the form of chloramphenicol sodium succinate, not more than one gram of chloramphenicol per vial;
(c) where the preparation is for ophthalmic use, the preparation contains not more than one per cent chloramphenicol; and
(d) where the preparation is for oral use, the preparation
(i) is in tablet or capsule form and contains not more than one gram of chloramphenicol per tablet or capsule, or
(ii) is in the form of a chloramphenicol palmitate suspension and contains not more than three grams of chloramphenicol per container.
C.01.611 (1) The Director may, in writing, from time to time require the manufacturer of a drug recommended for administration to animals that may be consumed as food
(a) to file with him in respect of that drug a submission, in form and content satisfactory to the Director, describing in detail tests carried out to determine that no residues of the drug, except residues within the limits prescribed by these Regulations, remain in meat, meat by-products, eggs or milk; and
(b) to print on the principal display panel of the outer label, the inner label and the packaging insert, if any, that describes the drug, a warning that meat, meat by-products, eggs or milk from animals to which the drug has been administered cannot be sold for consumption as food unless there has elapsed since the administration of the drug a period of time specified by the Director, based on a review of the available data with respect to drug residue.
(2) No manufacturer shall sell a drug in respect of which the Director has required a warning to be printed pursuant to paragraph (1)(b) unless the manufacturer has complied with that request.
C.01.612 [Repealed, SOR/94-568, s. 3]
Contraceptive Drugs
C.01.625 Contraceptive drugs that are manufactured, sold or represented for use in the prevention of conception and that are not listed in Schedule F may be advertised to the general public.
DIVISION 1A
Establishment Licences
Interpretation
C.01A.001 (1) The definitions in this subsection apply in this Division and in Divisions 2 to 4.
antimicrobial agent
antimicrobial agent means a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined in the Medical Devices Regulations, that
(a) are not invasive devices as defined in those Regulations; and
(b) are intended to come into contact with intact skin only. (agent antimicrobien)
batch certificate
batch certificate means a certificate issued by the fabricator of a lot or batch of a drug that is exported within the framework of a mutual recognition agreement and in which the fabricator
(a) identifies the master production document for the drug and certifies that the lot or batch has been fabricated, packaged/labelled and tested in accordance with the procedures described in that document;
(b) provides a detailed description of the drug, including
(i) a statement of all properties and qualities of the drug, including the identity, potency and purity of the drug, and
(ii) a statement of tolerances for the properties and qualities of the drug;
(c) identifies the analytical methods used in testing the lot or batch and provides details of the analytical results obtained;
(d) sets out the addresses of the buildings at which the lot or batch was fabricated, packaged/labelled and tested; and
(e) certifies that the lot or batch was fabricated, packaged/labelled and tested in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards. (certificat de lot)
class monograph
class monograph means a document prepared by the Department of Health that
(a) lists the types and strengths of medicinal ingredients that may be contained in drugs of a specified class; and
(b) sets out labelling and other requirements that apply to those drugs. (monographie de classe)
dilute drug premix
dilute drug premix means a drug for veterinary use that results from mixing a drug premix with a feed as defined in section 2 of the Feeds Act, to such a level that at least 10 kg of the resulting mixture is required to medicate one tonne of complete feed, as defined in section 2 of the Feeds Regulations, 1983, with the lowest approved dosage level of the drug. (prémélange médicamenteux dilué)
dosage form class
dosage form class means a parenteral, tablet, capsule, solution, suspension, aerosol, powder, suppository, medical gas or drug premix, or any other dosage form class designated by the Minister. (classe de forme posologique)
drug premix
drug premix means a drug for veterinary use to which a drug identification number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act. (prémélange médicamenteux)
fabricate
fabricate means to prepare and preserve a drug for the purposes of sale. (manufacturer)
import
import means to import into Canada a drug for the purpose of sale. (importer)
MRA country
MRA country means a country that is a participant in a mutual recognition agreement with Canada. (pays participant)
mutual recognition agreement
mutual recognition agreement means an international agreement that provides for the mutual recognition of compliance certification for good manufacturing practices for drugs. (accord de reconnaisance mutuelle)
package/label
package/label means to put a drug in its immediate container or to affix the inner or outer label to the drug. (emballer-étiqueter)
pharmaceutical
pharmaceutical means a drug other than a drug listed in Schedule C or D to the Act. (produit pharmaceutique)
recognized building
recognized building means, in respect of the fabrication, packaging/labelling or testing of a drug, a building that a regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug has recognized as meeting its good manufacturing practices standards in respect of that activity for that drug. (bâtiment reconnu)
regulatory authority
regulatory authority means a government agency or other entity in an MRA country that has a legal right to control the use or sale of drugs within that country and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with legal requirements. (autorité réglementaire)
site
site[Repealed, SOR/2002-368, s. 1]
wholesale
wholesale means to sell any of the following drugs, other than at retail sale, where the seller’s name does not appear on the label of the drugs:
(a) a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations or a controlled drug as defined in subsection G.01.001(1); or
(b) a narcotic as defined in the Narcotic Control Regulations. (vendre en gros)
(2) In this Division and in Division 2, drug means a drug in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule C to the Act or in Schedule D to the Act that is of biological origin. It does not include a dilute drug premix, a medicated feed as defined section 2 of the Feeds Regulations, 1983, a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015 or a drug listed in Schedule H to the Act.
(3) Where the Minister designates additional dosage form classes, the Minister shall make a list of those classes available on request.
Application
C.01A.002 (1) This Division does not apply to
(a) wholesaling a drug premix;
(b) importing or compounding, pursuant to a prescription, a drug that is not commercially available in Canada by one of the following persons, namely,
(i) a pharmacist,
(ii) a practitioner, and
(iii) a person who compounds a drug under the supervision of a practitioner;
(c) any activity with respect to a drug that is used only for the purposes of clinical testing in accordance with subsection C.05.006(1) or section C.08.005;
(d) fabricating, packaging/labelling, testing as required under Division 2, distributing as a distributer referred to in section C.01A.003, wholesaling or importing any of the following drugs for which prescriptions are not required and that are for human use in dosage form and not represented as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states set out in Schedule A to the Act, namely,
(i) homeopathic drugs,
(ii) drugs that meet the requirements of a class monograph entitled “Vitamin Supplements”, “Mineral Supplements”, “Dietary Vitamin Supplements” or “Dietary Mineral Supplements”, as the case may be, and
(iii) drugs that
(A) contain a plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed, including traditional herbal medicines, traditional Chinese medicines, ayurvedic (East Indian) medicines and traditional aboriginal (North American) medicines, and
(B) the medical use of which is based solely on historical and ethnological evidence from references relating to a medical system other than one based on conventional scientific standards; and
(e) fabricating, packaging/labelling, testing, distributing, and importing of antimicrobial agents.
(2) This Division and Divisions 2 to 4 do not apply to the affixing of a label to a previously labelled container.
C.01A.003 This Division and Divisions 2 to 4 apply to the following distributors:
(a) a distributor of a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations, a controlled drug as defined in subsection G.01.001(1) or a narcotic as defined in the Narcotic Control Regulations, who does not hold the drug identification number for the drug or narcotic; and
(b) a distributor of a drug for which that distributor holds the drug identification number.
Prohibition
C.01A.004 (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence,
(a) fabricate, package/label, distribute as set out in section C.01A.003, import or wholesale a drug; or
(b) perform the tests, including examinations, required under Division 2.
(2) A person does not require an establishment licence to perform tests under Division 2 if the person holds an establishment licence as a fabricator, a packager/labeller, a distributor referred to in paragraph C.01A.003(b) or an importer.
(3) No person shall carry on an activity referred to in subsection (1) in respect of a narcotic as defined in the Narcotic Control Regulations or a controlled drug as defined in subsection G.01.001(1) unless the person holds a licence for that narcotic or drug under the Narcotic Control Regulations or Part G of these Regulations, as the case may be.
Application for Establishment Licence
C.01A.005 Subject to section C.01A.006, a person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information:
(a) the applicant’s name, address and telephone number, and their facsimile number and electronic mail address, if any;
(b) the name and telephone number, and the facsimile number and electronic mail address, if any, of a person to contact in case of an emergency;
(c) each activity set out in Table I to section C.01A.008 for which the licence is requested;
(d) each category of drugs set out in Table II to section C.01A.008 for which the licence is requested;
(e) each dosage form class in respect of which the applicant proposes to carry out a licensed activity, and whether it will be in a sterile dosage form;
(f) whether the applicant proposes to carry out a licensed activity in respect of a drug that is a bulk process intermediate;
(g) the address of each building in Canada in which the applicant proposes to fabricate, package/label, test as required under Division 2 or store drugs, specifying for each building which of those activities and for which category of drugs and, for each category,
(i) the dosage form classes, and whether any drugs will be in a sterile dosage form, and
(ii) whether any drugs will be bulk process intermediates;
(h) the address of each building in Canada at which records will be maintained;
(i) whether any building referred to in paragraphs (g) and (h) is a dwelling-house;
(j) the drug identification number, if any, or a name that clearly identifies the drug,
(i) for each narcotic as defined in the Narcotic Control Regulations or each controlled drug as defined in subsection G.01.001(1) for which the licence is requested, and
(ii) for each other drug within a category of drugs for which the licence is requested, unless the licence is to perform tests required under Division 2, distribute as set out in paragraph C.01A.003(a), or wholesale;
(k) if any of the buildings referred to in paragraph (g) have been inspected under the Act or these Regulations, the date of the last inspection;
(l) evidence that the applicant’s buildings, equipment and proposed practices and procedures meet the applicable requirements of Divisions 2 to 4;
(m) in the case of an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building,
(i) the name and address of each fabricator, packager/labeller and tester of the drug and the address of each building at which the drug is fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drug and
(A) the dosage form class and whether the drug is in a sterile dosage form, and
(B) whether the drug is a bulk process intermediate,
(ii) in respect of each activity done in an MRA country at a recognized building, the name of the regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug and that has recognized that building as meeting its good manufacturing practices standards in respect of that activity for that drug, and
(iii) in respect of any other activities,
(A) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or
(B) other evidence establishing that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4;
(n) in the case of any other importer, the name and address of each fabricator, packager/labeller and tester of the drugs proposed to be imported and the address of each building at which the drugs will be fabricated, packaged/labelled and tested, specifying for each building which of those activities and for which category of drugs and, for each category,
(i) the dosage form classes and whether any drugs will be in a sterile dosage form, and
(ii) whether any drugs will be bulk process intermediates; and
(o) in the case of an importer referred to in paragraph (n),
(i) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or
(ii) other evidence establishing that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4.
C.01A.006 (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the applicable information specified in section C.01A.005.
(2) An establishment licence must be amended where the licensee proposes
(a) to add an activity or category of drugs, as set out in the tables to section C.01A.008;
(b) in respect of a category of drugs and activity indicated in the licence, to authorize sterile dosage forms of the category;
(c) to add any building in Canada at which drugs are authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, or to add, for an existing building, an authorization to fabricate, package/label, test or store a category of drugs, or sterile dosage forms of the category; and
(d) in addition to the matters set out in paragraphs (a) to (c), in the case of an importer,
(i) to add a fabricator, packager/labeller or tester of a drug,
(ii) to amend the name or address of a fabricator, packager/labeller or tester indicated in the licence, and
(iii) if the address of the buildings at which drugs are authorized to be fabricated, packaged/labelled or tested is indicated in the licence, to add additional buildings or, for an existing building, to add an authorization to fabricate, package/label or test a category of drugs, or sterile dosage forms of the category.
C.01A.007 (1) The Minister may, on receipt of an application for an establishment licence or an amended establishment licence, require the submission of further details pertaining to the information contained in the application that are necessary to enable the Minister to process the application.
(2) When considering an application for an establishment licence or an amended establishment licence, the Minister may require that
(a) an inspection be made during normal business hours of any building referred to in paragraph C.01A.005(1)(g) or (h); and
(b) the applicant, if a fabricator, a packager/labeller, a person who performs tests required under Division 2, a distributor referred to in paragraph C.01A.003(b) or an importer, supply samples of any material to be used in the fabrication, packaging/labelling or testing of a drug.
Issuance
C.01A.008 (1) Subject to section C.01A.010, the Minister shall, on receipt of the information and material required by sections C.01A.005 to C.01A.007, issue or amend an establishment licence.
(2) The establishment licence shall indicate
(a) each activity that is authorized and the category of drugs for which each activity is authorized, as set out in the tables to this section, specifying for each activity and category whether sterile dosage forms are authorized;
(b) the address of each building in Canada at which a category of drugs is authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, specifying for each building which of those activities and for which category of drugs, and whether sterile dosage forms of the category are authorized; and
(c) in addition to the matters referred to in paragraphs (a) and (b), in the case of an importer,
(i) the name and address of each fabricator, packager/labeller and tester from whom the importer is authorized to obtain the drug for import, and
(ii) the address of each building at which the drug is authorized to be fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drugs that are authorized, and whether sterile dosage forms are authorized.
(d) [Repealed, SOR/2002-368, s. 5]
(3) The Minister may indicate in an establishment licence a period for which records shall be retained under Division 2 that, based on the safety profile of the drug or materials, is sufficient to ensure the health of the consumer.
(4) The Minister may, in addition to the requirements of subsection (2), set out in an establishment licence terms and conditions respecting
(a) the tests to be performed in respect of a drug, and the equipment to be used, to ensure that the drug is not unsafe for use; and
(b) any other matters necessary to prevent injury to the health of consumers, including conditions under which drugs are fabricated, packaged/labelled or tested.
TABLE I
ItemActivities1Fabricate2Package/label3Perform the tests, including any examinations, required under Division 24Distribute as set out in paragraph C.01A.003(a)5Distribute as set out in paragraph C.01A.003(b)6Import7WholesaleTABLE II
ItemCategories of drugs1Pharmaceuticals2Vaccines3Whole blood and its components4Drugs listed in Schedule D to the Act, other than vaccines or whole blood and its components5Drugs listed in Schedule C to the Act6Drugs listed in Schedule F to these Regulations, controlled drugs as defined in subsection G.01.001(1) and narcotics as defined in the Narcotic Control RegulationsC.01A.009 An establishment licence expires on December 31 of each year.
Refusal to Issue
C.01A.010 (1) The Minister may refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if
(a) the applicant has made a false or misleading statement in relation to the application for the licence; or
(b) the applicant has had an establishment licence suspended in respect of the matter.
(2) The Minister shall refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that issuing or amending an establishment licence in respect of the matter would constitute a risk to the health of the consumer.
(3) Where the Minister refuses to issue or amend an establishment licence, the Minister shall
(a) notify the applicant in writing of the reasons for the refusal; and
(b) give the applicant an opportunity to be heard.
Terms and Conditions
C.01A.011 (1) Every person who holds an establishment licence shall comply with
(a) the requirements and the terms and conditions of the establishment licence; and
(b) the applicable requirements of Divisions 2 to 4.
(2) [Repealed, SOR/2000-120, s. 4]
C.01A.012 (1) The Minister may amend the terms and conditions of an establishment licence if the Minister believes on reasonable grounds that an amendment is necessary to prevent injury to the health of the consumer.
(2) The Minister shall give at least 15 days notice in writing to the holder of the establishment licence of the proposed amendment, the reasons for the amendment and its effective date.
Notification
C.01A.013 Every person who holds an establishment licence shall notify the Minister in writing within 15 days after
(a) there is any change to the information referred to in any of paragraphs C.01A.005(a),(b),(e),(f),(h) and (i), and subparagraphs C.01A.005(g)(i) and (ii); or
(b) an event occurs that results in their being in contravention of any of the applicable requirements of Divisions 2 to 4, where it may affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested as required under Division 2 or stored by them.
C.01A.014 (1) No licensee shall carry on a licensed activity in respect of any category of drugs if a change referred to in subsection (2) has occurred in respect of that category, unless
(a) they have filed with the Minister a notice that contains sufficient information to enable the Minister to assess the safety of the drug, taking into account the change; and
(b) the Minister has issued to them a letter indicating that the information will be reviewed and has not, within 90 days after issuing the letter, sent them a notice indicating that the change is not acceptable.
(2) Notification is required in respect of the following changes where they may affect whether a drug can be fabricated, packaged/labelled, tested or stored in accordance with the applicable requirements of Divisions 2 to 4:
(a) changes to the plans and specifications of a building where a drug is fabricated, packaged/labelled, tested or stored;
(b) changes to the equipment that is used in the fabrication, packaging/labelling or testing of a drug;
(c) changes to the practices or procedures; and
(d) in the case of an importer, other than an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building, any change referred to in paragraphs (a) to (c) that relates to the fabricator, packager/labeller or tester of the drug being imported.
C.01A.015 (1) An importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building shall immediately notify the Minister if the fabricator, packager/labeller or tester indicated in the importer’s establishment licence no longer holds a valid permit, licence or other authorization issued by the regulatory authority that recognized that building.
(2) The Minister shall, on receiving a notification under subsection (1), amend the importer’s establishment licence by removing the name and address of that fabricator, packager/labeller or tester.
Suspension
C.01A.016 (1) Subject to subsection (3), the Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that
(a) the licensee has contravened any provision of the Act or these Regulations; or
(b) the licensee has made a false or misleading statement in the application for the establishment licence.
(2) Before suspending an establishment licence, the Minister shall consider
(a) the licensee’s history of compliance with the Act and these Regulations; and
(b) the risk that allowing the licence to continue in force would constitute for the health of the consumer.
(3) Subject to subsection C.01A.017(1), the Minister shall not suspend an establishment licence until
(a) an inspector has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;
(b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and
(c) the licensee has been given an opportunity to be heard in respect of the suspension.
C.01A.017 (1) The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health of the consumer, by giving the licensee a notice in writing that states the reason for the suspension.
(2) A licensee may request of the Minister, in writing, that the suspension be reconsidered.
(3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with the opportunity to be heard.
C.01A.018 The Minister may reinstate an establishment licence after it has been suspended.
Designation
C.01A.019 (1) For the purposes of this Division and Divisions 2 to 4, a regulatory authority that is set out in column 1 of the table to this section is hereby designated in respect of the activities set out in column 3 for the drug or category of drugs set out in column 2.
(2) Whole blood and its components are excluded from the drugs and categories of drugs set out in column 2 of the table to this section.
(3) The lot release of drugs listed in Schedule D to the Act is excluded from the activity of testing set out in column 3 of the table to this section.
TABLE
Designated Regulatory Authorities
ItemColumn 1Column 2Column 3Regulatory authorityDrug or category of drugsActivities1Swissmedic, Swiss Agency for Therapeutic Products, Bern, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testingDrugs listed in Schedules C and D to the Act2Regional Medicines Inspectorate of Northwestern Switzerland (RFS-NW), Basel, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testingDrugs listed in Schedules C and D to the Act3Regional Medicines Inspectorate of Eastern and Central Switzerland (RFS-OZ), Zurich, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testingDrugs listed in Schedules C and D to the Act4Regional Medicines Inspectorate of Southern Switzerland (RFS-S), Ticino, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testingDrugs listed in Schedules C and D to the Act5Regional Medicines Inspectorate of Western Switzerland (RFS-W), Lausanne, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testingDrugs listed in Schedules C and D to the ActDIVISION 2
Good Manufacturing Practices
C.02.001 [Repealed, SOR/97-12, s. 5.1]
C.02.002 In this Division,
drug
drug[Repealed, SOR/97-12, s. 6]
importer
importer[Repealed, SOR/97-12, s. 6]
medical gas
medical gas means any gas or mixture of gases manufactured, sold or represented for use as a drug; (gaz médical)
packaging material
packaging material includes a label; (matériel d’emballage)
produce
produce[Repealed, SOR/97-12, s. 6]
quality control department
quality control department means a quality control department referred to in section C.02.013; (service du contrôle de la qualité)
specifications
specifications means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes
(a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material,
(b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and
(c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (spécifications)
C.02.002.1 This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents.
Sale
C.02.003 No distributor referred to in paragraph C.01A.003(b) and no importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division.
Premises
C.02.004 The premises in which a lot or batch of a drug is fabricated or packaged/labelled shall be designed, constructed and maintained in a manner that
(a) permits the operations therein to be performed under clean, sanitary and orderly conditions;
(b) permits the effective cleaning of all surfaces therein; and
(c) prevents the contamination of the drug and the addition of extraneous material to the drug.
Equipment
C.02.005 The equipment with which a lot or batch of a drug is fabricated, packaged/labelled or tested shall be designed, constructed, maintained, operated and arranged in a manner that
(a) permits the effective cleaning of its surfaces;
(b) prevents the contamination of the drug and the addition of extraneous material to the drug; and
(c) permits it to function in accordance with its intended use.
Personnel
C.02.006 Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic and other training as the Director considers satisfactory in the interests of the health of the consumer or purchaser.
Sanitation
C.02.007 (1) Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel.
(2) The sanitation program referred to in subsection (1) shall include
(a) cleaning procedures for the premises where the drug is fabricated or packaged/labelled and for the equipment used in the fabrication or packaging/labelling; and
(b) instructions on the sanitary fabrication and packaging/labelling of drugs and the handling of materials used in the fabrication and packaging/labelling of drugs.
C.02.008 (1) Every person who fabricates or packages/labels a drug shall have, in writing, minimum requirements for the health and the hygienic behaviour and clothing of personnel to ensure the clean and sanitary fabrication and packaging/labelling of the drug.
(2) No person shall have access to any area where a drug is exposed during its fabrication or packaging/labelling if the person
(a) is affected with or is a carrier of a disease in a communicable form; or
(b) has an open lesion on any exposed surface of the body.
Raw Material Testing
C.02.009 (1) Each lot or batch of raw material shall be tested against the specifications for that raw material prior to its use in the fabrication of a drug.
(2) No lot or batch of raw material shall be used in the fabrication of a drug unless that lot or batch of raw material complies with the specifications for that raw material.
(3) Notwithstanding subsection (1), water may, prior to the completion of its tests under that subsection, be used in the fabrication of a drug.
(4) Where any property of a raw material is subject to change on storage, no lot or batch of that raw material shall be used in the fabrication of a drug after its storage unless the raw material is retested after an appropriate interval and complies with its specifications for that property.
(5) Where the specifications referred to in subsections (1), (2) and (4) are not prescribed, they shall
(a) be in writing;
(b) be acceptable to the Director who shall take into account the specifications contained in any publication mentioned in Schedule B to the Act; and
(c) be approved by the person in charge of the quality control department.
C.02.010 (1) The testing referred to in section C.02.009 shall be performed on a sample taken
(a) after receipt of each lot or batch of raw material on the premises of the fabricator; or
(b) subject to subsection (2), before receipt of each lot or batch of raw material on the premises of the fabricator, if
(i) the fabricator
(A) has evidence satisfactory to the Director to demonstrate that raw materials sold to him by the vendor of that lot or batch of raw material are consistently manufactured in accordance with and consistently comply with the specifications for those raw materials, and
(B) undertakes periodic complete confirmatory testing with a frequency satisfactory to the Director, and
(ii) the raw material has not been transported or stored under conditions that may affect its compliance with the specifications for that raw material.
(2) After a lot or batch of raw material is received on the premises of the fabricator, the lot or batch of raw material shall be tested for identity.
Manufacturing Control
C.02.011 (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall have written procedures prepared by qualified personnel in respect of the drug to ensure that the drug meets the specifications for that drug.
(2) Every person required to have written procedures referred to in subsection (1) shall ensure that each lot or batch of the drug is fabricated, packaged/labelled and tested in compliance with those procedures.
C.02.012 (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler of a drug shall maintain
(a) a system of control that permits complete and rapid recall of any lot or batch of the drug that is on the market; and
(b) a program of self-inspection.
(2) Every fabricator and packager/labeller and, subject to subsections (3) and (4), every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall maintain a system designed to ensure that any lot or batch of the drug fabricated and packaged/labelled on premises other than their own is fabricated and packaged/labelled in accordance with the requirements of this Division.
(3) The distributor referred to in paragraph C.01A.003(b) of a drug that is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities is not required to comply with the requirements of subsection (2) in respect of that drug.
(4) If a drug is fabricated or packaged/labelled in an MRA country at a recognized building, the distributor referred to in paragraph C.01A.003(b) or importer of the drug is not required to comply with the requirements of subsection (2) in respect of that activity for that drug if
(a) the address of the building is set out in that person’s establishment licence; and
(b) that person retains a copy of the batch certificate for each lot or batch of the drug received by that person.
Quality Control Department
C.02.013 (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall have on their premises in Canada a quality control department that is supervised by personnel described in section C.02.006.
(2) The quality control department referred to in subsection (1) shall be a distinct organizational unit that functions and reports to management independently of any other functional unit, including the manufacturing, processing, packaging or sales unit.
C.02.014 (1) No lot or batch of drug shall be made available for sale unless the sale of that lot or batch is approved by the person in charge of the quality control department.
(2) A drug that is returned to the fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer thereof shall not be made available for further sale unless the sale of that drug is approved by the person in charge of the quality control department.
(3) No lot or batch of raw material or of packaging/labelling material shall be used in the fabrication or packaging/labelling of a drug unless the material is approved for that use by the person in charge of the quality control department.
(4) No lot or batch of a drug shall be reprocessed without the approval of the person in charge of the quality control department.
C.02.015 (1) All fabrication, packaging/labelling, testing, storage and transportation methods and procedures that may affect the quality of a drug shall be examined and approved by the person in charge of the quality control department before their implementation.
(2) The person in charge of the control department shall cause to be investigated every complaint on quality that is received and cause corrective action to be taken where necessary.
(3) The person in charge of the quality control department shall cause all tests or examinations required pursuant to this Division to be performed by a competent laboratory.
Packaging Material Testing
C.02.016 (1) Each lot or batch of packaging material shall, prior to its use in the packaging of a drug, be examined or tested against the specifications for that packaging material.
(2) No lot or batch of packaging material shall be used in the packaging of a drug unless the lot or batch of packaging material complies with the specifications for that packaging material.
(3) The specifications referred to in subsections (1) and (2) shall
(a) be in writing;
(b) be acceptable to the Director who shall take into account the specifications contained in any publication mentioned in Schedule B to the Act; and
(c) be approved by the person in charge of the quality control department.
C.02.017 (1) The examination or testing referred to in section C.02.016 shall be performed on a sample taken
(a) after receipt of each lot or batch of packaging material on the premises of the person who packages a drug; or
(b) subject to subsection (2), before receipt of each lot or batch of packaging material on the premises of the person who packages a drug, if
(i) that person
(A) has evidence satisfactory to the Director to demonstrate that packaging materials sold to him by the vendor of that lot or batch of packaging material are consistently manufactured in accordance with and consistently comply with the specifications for those packaging materials, and
(B) undertakes periodic complete confirmatory examination or testing with a frequency satisfactory to the Director,
(ii) the packaging material has not been transported or stored under conditions that may affect its compliance with the specifications for that packaging material.
(2) After a lot or batch of packaging material is received on the premises of the person who packages a drug,
(a) the lot or batch of the packaging material shall be examined or tested for identity; and
(b) the labels shall be examined or tested in order to ensure that they comply with the specifications for those labels.
Finished Product Testing
C.02.018 (1) Each lot or batch of a drug shall, prior to its availability for sale, be tested against the specifications for that drug.
(2) No lot or batch of a drug shall be available for sale unless it complies with the specifications for that drug.
(3) The specifications referred to in subsections (1) and (2) shall
(a) be in writing;
(b) be approved by the person in charge of the quality control department; and
(c) comply with the Act and these Regulations.
C.02.019 (1) Subject to subsections (3) and (4), in the case of a packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer, the testing referred to in section C.02.018 shall be performed on a sample taken
(a) after receipt of each lot or batch of the drug on the premises in Canada of the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer of the drug; or
(b) subject to subsection (2), before receipt of each lot or batch of the drug on the premises described in paragraph (a), if
(i) the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer
(A) has evidence satisfactory to the Director to demonstrate that drugs sold to him by the vendor of that lot or batch of the drug are consistently manufactured in accordance with and consistently comply with the specifications for those drugs, and
(B) undertakes periodic complete confirmatory testing with a frequency satisfactory to the Director, and
(ii) the drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.
(2) Where the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer of a drug receives a lot or batch of the drug on their premises in Canada, and the useful life of the drug is more than 30 days, the lot or batch shall be tested for identity, and the packager/labeller shall confirm the identity after the lot or batch is packaged/labelled.
(3) The distributor referred to in paragraph C.01A.003(b) of a drug that is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities is not required to comply with the requirements of subsections (1) and (2) in respect of that drug.
(4) If a drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building, the distributor referred to in paragraph C.01A.003(b) or importer of that drug is not required to comply with the requirements of subsections (1) and (2) in respect of that drug if
(a) the address of the building is set out in that person’s establishment licence; and
(b) that person retains a copy of the batch certificate for each lot or batch of the drug received by that person.
Records
C.02.020 (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall maintain on their premises in Canada, for each drug sold,
(a) master production documents for the drug;
(b) evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored in accordance with the procedures described in the master production documents;
(c) evidence that the conditions under which the drug was fabricated, packaged/labelled, tested and stored are in compliance with the requirements of this Division;
(d) evidence establishing the period of time during which the drug in the container in which it is sold will meet the specifications for that drug; and
(e) adequate evidence of the testing referred to in section C.02.018.
(2) Every distributor referred to in paragraph C.01A.003(b) and importer shall make available to the Director, on request, the results of testing performed on raw materials and packaging/labelling material for each lot or batch of a drug sold.
(3) Every fabricator shall maintain on his premises
(a) the written specifications for the raw material; and
(b) adequate evidence of the testing of the raw materials referred to in section C.02.009.
(4) Every person who packages a drug shall maintain on his premises
(a) the written specifications for the packaging material; and
(b) adequate evidence of the packaging material examination or testing referred to in section C.02.016.
(5) Every fabricator shall maintain on their premises in Canada
(a) detailed plans and specifications of each building in Canada at which they fabricate, package/label or test; and
(b) a description of the design and construction of those buildings.
(6) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada details of the personnel employed to supervise the fabrication, packaging/labelling and testing, including each person’s title, responsibilities, qualifications, experience and training.
C.02.021 (1) Subject to subsection (2), all records and evidence on the fabrication, packaging/labelling, testing and storage of a drug that are required to be maintained under this Division shall be retained for a period of at least one year after the expiration date on the label of the drug, unless otherwise specified in the person’s establishment licence.
(2) All records and evidence on the testing of raw materials and packaging/labelling materials that are required to be maintained under this Division shall be retained for a period of at least five years after the materials were last used in the fabrication or packaging/labelling of a drug, unless otherwise specified in the person’s establishment licence.
C.02.022 Every distributor referred to in section C.01A.003, wholesaler and importer of a drug shall retain records of the sale of each lot or batch of the drug, which enable them to recall the lot or batch from the market, for a period of at least one year after the expiration date of that lot or batch, unless otherwise specified in their establishment licence.
C.02.023 (1) On receipt of a complaint respecting the quality of a drug, every distributor referred to in paragraph C.01A.003(b) and importer of the drug shall make a record of the complaint and of its investigation and retain the record for a period of at least one year after the expiration date of the lot or batch of that drug, unless otherwise specified in their establishment licence.
(2) On receipt of any information respecting the quality or hazards of a drug, every distributor referred to in paragraph C.01A.003(b) and importer of the drug shall make a record of the information and retain it for a period of at least one year after the expiration date of the lot or batch of that drug, unless otherwise specified in their establishment licence.
C.02.024 (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler shall
(a) maintain records of the results of the self-inspection program required by section C.02.012 and of any action taken in connection with that program; and
(b) retain those records for a period of at least three years.
(2) Every person who fabricates or packages/labels a drug shall
(a) maintain records on the operation of the sanitation program required to be implemented under section C.02.007; and
(b) retain those records for a period of at least three years.
Samples
C.02.025 (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for a period of at least one year after the expiration date on the label of the drug, unless otherwise specified in the distributor’s or importer’s establishment licence.
(2) The fabricator shall retain a sample of each lot or batch of raw materials used in the fabrication of a drug for a period of at least two years after the materials were last used in the fabrication of the drug, unless otherwise specified in the fabricator’s establishment licence.
C.02.026 The samples referred to in section C.02.025 shall be in an amount that is sufficient to determine whether the drug or raw material complies with the specifications for that drug or raw material.
Stability
C.02.027 Every distributor referred to in paragraph C.01A.003(b) and importer shall establish the period of time during which each drug in the package in which it is sold will comply with the specifications.
C.02.028 Every distributor referred to in paragraph C.01A.003(b) and importer shall monitor, by means of a continuing program, the stability of the drug in the package in which it is sold.
Sterile Products
C.02.029 In addition to the other requirements of this Division, a drug that is intended to be sterile shall be fabricated and packaged/labelled
(a) in separate and enclosed areas;
(b) under the supervision of personnel trained in microbiology; and
(c) by a method scientifically proven to ensure sterility.
Medical Gases
C.02.030 The provisions of sections C.02.025, C.02.027 and C.02.028 do not apply to medical gases.
Division 3
Schedule C Drugs
C.03.001 In this Division,
drug
drug means a drug listed in Schedule C to the Act that is in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule C to the Act that is of biological origin; (drogue)
licence
licence or Canadian licence[Repealed, SOR/97-12, s. 22]
manufacturer
manufacturer[Repealed, SOR/97-12, s. 22]
master lot
master lot means a quantity of a drug from which a lot is prepared for sale by subsequent dilution or mixture; (maître-lot)
radionuclide generator
radionuclide generator means a radioactive parent and daughter
(a) contained in an ion-exchange column, or
(b) dissolved in a suitable solvent in a liquid-liquid extraction system
where the radioactive daughter is separated from its parent by
(c) elution from the ion exchange column, or
(d) a solvent extraction procedure. (générateur de radionucléide)
C.03.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.
C.03.002 to C.03.005 [Repealed, SOR/97-12, s. 24]
C.03.006 [Repealed, SOR/97-12, s. 67]
C.03.007 to C.03.011 [Repealed, SOR/97-12, s. 26]
C.03.012 On written request from the Director, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot or master lot of the drug before it is sold, and no person shall sell a lot of which the protocol or sample fails to meet the requirements of these Regulations.
C.03.013 No person shall fabricate or import a drug that is derived from animal tissue unless the tissue is obtained from a healthy animal free from infectious disease.
C.03.014 (1) Section C.01.004 does not apply to a drug.
(2) and (3) [Repealed, SOR/97-12, s. 28]
C.03.015 Every package of a drug listed or described in Schedule F in the Regulations, other than
(a) a drug sold to a drug fabricator,
(b) a drug dispensed pursuant to a prescription,
(c) a radiopharmaceutical as defined in section C.03.201, or
(d) a component or kit as defined in section C.03.205,
shall carry the symbol Pr on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label.
C.03.030 to C.03.045 [Repealed, SOR/81-335, s. 2]
Radiopharmaceuticals
C.03.201 In these Regulations, radiopharmaceutical means a drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons.
C.03.202 (1) Every package containing a radiopharmaceutical, other than a radionuclide generator, shall carry,
(a) on both the inner and the outer labels,
(i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name,
(ii) the name of the distributor referred to in paragraph C.01A.003(b), and
(iii) the lot number; and
(b) on the outer label
(i) the address of the distributor referred to in paragraph C.01A.003(b),
(ii) the standard that the drug professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act,
(iii) a statement of the pharmaceutical form or the route of administration of the drug,
(iv) a statement of the recommended use and the recommended radioactivity to be administered for that use, or a reference to an accompanying package insert that shows such information,
(v) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof,
(vi) the radiation warning symbol required by the Atomic Energy Control Regulations and the statement “Caution — Radioactive Material” “Attention — Produit radioactif”,
(vii) the names and a statement of the amounts of any preservatives or stabilizing agents contained in the drug,
(viii) the names and a statement of the amounts of all other non-radioactive contents of the drug,
(ix) a statement of the total radioactivity content of the drug including overfill,
(x) a statement of the total volume of the drug including overfill, except where its contents are entirely in gaseous, capsule or lyophilized form,
(xi) a statement of the concentration of radioactive material in the drug expressed as
(A) units of radioactivity per capsule or
(B) units of radioactivity per unit volume,
except where the contents of the drug are entirely in gaseous or lyophilized form,
(xii) a statement of the specific activity of the drug expressed as units of radioactivity per unit weight of carrier present or the statement “carrier-free” or “sans entraîneur”, whichever is applicable,
(xiii) a statement of the reference time in respect of the radioactivity values mentioned in subparagraphs (ix), (xi) and (xii), the name of the month being written or designated by letter abbreviation,
(xiv) a statement of the recommended useful life or the date after which the drug is not recommended for use, the name of the month being written or designated by letter abbreviation, and
(xv) a statement of the special storage requirements with reference to temperature and light.
(2) [Repealed, SOR/2001-203, s. 2]
(3) Subparagraph (1)(b)(viii) of this section does not apply where the information referred to in that subparagraph is shown on a package insert that accompanies the drug.
(4) Section C.01.005 does not apply to a radiopharmaceutical.
C.03.203 (1) Every radionuclide generator shall carry on the inner label
(a) the proper name of the radionuclide generator, which proper name, where there is a brand name, shall immediately precede or follow the brand name;
(b) the name and address of the distributor referred to in paragraph C.01A.003(b);
(c) the lot number;
(d) the standard that the radionuclide generator professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act;
(e) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof;
(f) the radiation warning symbol required by the Atomic Energy Control Regulations and the statement “Caution — Radioactive Material” “Attention — Produit radioactif”;
(g) a statement of the total parent radioactivity contained in the radionuclide generator;
(h) a statement of the hour and date at which the radioactivity value mentioned in paragraph (g) is valid, the name of the month being written or designated by letter abbreviation;
(i) a statement of the recommended useful life or the date after which the radionuclide generator is not recommended for use, the name of the month being written or designated by letter abbreviation;
(j) a statement of the recommended useful life of the drug after removal from the radionuclide generator;
(k) a statement of special storage requirements with reference to temperature or shielding;
(l) complete directions for use or a reference to an accompanying package insert that sets out such directions; and
(m) a statement cautioning against the dismantling of the radionuclide generator.
(2) Paragraphs (1)(i) and (j) of this section do not apply where the information referred to in those subparagraphs is shown on a package insert that accompanies the radionuclide generator.
C.03.204 (1) No person shall sell a drug containing technetium-99m at any time during the useful life of the drug if the drug also contains a radionuclidic impurity mentioned in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication mentioned in item 7 of Schedule B to the Act, in an amount greater than that shown in the monograph.
(2) No person shall sell a radionuclide generator from which can be removed a drug that contains technetium-99m, at any time during the useful life of the drug, if the drug also contains a radionuclidic impurity mentioned in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication mentioned in item 7 of Schedule B to the Act, in an amount greater than that shown in the monograph.
Drugs, other than Radionuclides, Sold or Represented for Use in the Preparation of Radiopharmaceuticals
C.03.205 For the purposes of sections C.03.206 to C.03.209,
component
component means
(a) a unit of a drug, other than a radionuclide, separately packaged in a kit for use in the preparation of a radiopharmaceutical, or
(b) an empty vial or other accessory item in a kit; (constituant)
kit
kit means a package
(a) that contains one or more separately packaged units of a drug, other than a radionuclide, and
(b) that may contain empty vials or other accessory items, for use in the preparation of radiopharmaceuticals. (trousse)
C.03.206 Sections C.01.005 and C.04.019 do not apply to a component or kit.
C.03.207 Every component shall be labelled to show
(a) adequate identification of the component and an adequate description of its function;
(b) where applicable, a quantitative list of its ingredients or a reference to the label of the kit that shows such information;
(c) the name of the distributor referred to in paragraph C.01A.003(b);
(d) the lot number;
(e) a statement of any special storage requirements with respect to temperature and light;
(f) the date after which the component is not recommended for use, the name of the month being written in full or designated by letter abbreviation; and
(g) adequate directions for use or a reference to the accompanying package insert that shows such directions.
C.03.208 Every kit shall be labelled to show
(a) its proper name;
(b) its brand name, if any;
(c) a list of its contents;
(d) the name and address of the distributor referred to in paragraph C.01A.003(b);
(e) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof;
(f) the lot number;
(g) a statement of any special storage requirements with respect to temperature and light;
(h) the date after which the kit is not recommended for use, the name of the month being written in full or designated by letter abbreviation;
(i) where the label of a component makes reference to the label of the kit that shows information as to the ingredients of the component, a quantitative list of the ingredients of that component;
(j) a statement of the sterility and apyrogenicity of the components;
(k) adequate directions for preparing the radiopharmaceutical or a reference to the accompanying package insert that shows such directions;
(l) a statement of the duration of the useful life of the prepared radiopharmaceutical;
(m) a statement of the storage requirements for the prepared radiopharmaceutical;
(n) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use, or a reference to the accompanying package insert that shows such information; and
(o) a statement of the route of administration of the prepared radiopharmaceutical.
(p) [Repealed, SOR/2001-203, s. 3]
C.03.209 A package insert shall be included in every kit and shall show
(a) the proper name and the brand name, if any, of the kit and a description of its use;
(b) a list of the contents of the kit;
(c) the name and address of the distributor referred to in paragraph C.01A.003(b) of the kit;
(d) identification of the radionuclides that can be used to prepare the radiopharmaceutical;
(e) directions for preparing the radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;
(f) a statement of the duration of the useful life of the prepared radiopharmaceutical;
(g) a description of the biological actions of the prepared radiopharmaceutical;
(h) indications and contraindications in respect of the prepared radiopharmaceutical;
(i) warnings and precautions in respect of the components and the prepared radiopharmaceutical;
(j) the adverse reactions, if any, associated with the prepared radiopharmaceutical;
(k) where applicable, the pharmacology and toxicology of the prepared radiopharmaceutical or a statement that such information is available on request;
(l) the radiation dosimetry in respect of the prepared radiopharmaceutical;
(m) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use;
(n) a statement of the route of administration of the prepared radiopharmaceutical; and
(o) a recommendation that the radiochemical purity and radioactivity content of the prepared radiopharmaceutical be checked prior to administration.
Division 4
Schedule D Drugs
C.04.001 In this Division,
date of manufacture
date of manufacture means
(a) in the case of a product for which a standard of potency exists, the date it satisfactorily passes a potency test,
(b) in the case of an animal product for which no standard of potency exists, the date of its removal from the animal, and
(c) in the case of a product other than an animal product for which no standard of potency exists, the date of cessation of growth; (date de fabrication)
drug
drug means a drug listed in Schedule D to the Act that is in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule D to the Act; (drogue)
licence
licence or Canadian licence[Repealed, SOR/97-12, s. 31]
manufacturer
manufacturer [Repealed, SOR/97-12, s. 31]
C.04.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.
C.04.002 This Division does not apply to a drug in oral dosage form that contains micro-organisms if the drug is recommended solely for restoring, normalizing or stabilizing the intestinal flora.
C.04.003 The date of issue of a drug shall be the date on which the finished product is removed from cold storage but in any case shall be, not later than
(a) six months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 10°C;
(b) 12 months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 5°C; or
(c) two years after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 0°C.
C.04.004 to C.04.006 [Repealed, SOR/97-12, s. 34]
C.04.007 [Repealed, SOR/97-12, s. 67]
C.04.008 to C.04.012 [Repealed, SOR/97-12, s. 36]
C.04.013 Every fabricator and packager/labeller shall safely segregate all work with spore-bearing, pathogenic micro-organisms and other infectious agents known to require special precautions in manipulation and shall take such care of equipment and arrangements for supervision that the possibility of contamination of other drugs is avoided.
C.04.014 No person shall conduct laboratory procedures of a diagnostic nature in their premises unless those procedures are entirely segregated from the fabrication, packaging/labelling and testing of drugs.
C.04.015 On written request from the Director, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot of the drug before it is sold, and no person shall sell any lot of that drug if the protocol or sample fails to meet the requirements of these Regulations.
C.04.016 All animals from which drugs are prepared and preserved shall be
(a) under the direct supervision of competent medical or veterinary personnel;
(b) kept in quarantine by the fabricator for at least seven days before use; and
(c) healthy and free from infectious disease.
C.04.017 A fabricator shall keep necropsy records of all animals that die or are killed after having been used in the production of a drug.
C.04.018 A fabricator shall immediately segregate, and report the fact to the Minister, any animal with actual or suspected vesicular stomatitis, foot and mouth disease, encephalomyelitis, infectious anaemia, glanders, anthrax, tetanus or any other serious infectious disease.
C.04.019 The provisions of section C.01.004 do not apply to a drug as defined in this Division but every package of such drug shall carry
(a) on both the inner and the outer labels
(i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name in type not less than one-half the size of that of the brand name,
(ii) the name of the distributor referred to in paragraph C.01A.003(b),
(iii) the potency of the drug, where applicable,
(iv) the recommended dose of the drug,
(v) the lot number,
(vi) the expiration date except upon the inner label of a single-dose container, and
(vii) adequate direction for use; and
(b) on the outer label
(i) the address of the distributor referred to in paragraph C.01A.003(b),
(ii) for whole blood and its components, the establishment licence number of the distributor referred to in paragraph C.01A.003(b), preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof,
(iii) the proper name, or the common name if there is no proper name, and the amount, of any preservative in the drug,
(iv) a statement that the drug shall be stored at a temperature of not less than 2°C and not more than 10°C, unless the Minister has received evidence demonstrating that such a statement is not required, and
(v) a statement of the net contents in terms of weight, measure, or number.
C.04.020 Except in the case of the following drugs, every package of a drug listed in Schedule F of these Regulations shall carry the symbol Pr on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label:
(a) a drug sold to a person who holds an establishment licence; and
(b) a drug dispensed pursuant to a prescription.
Bacterial Vaccines, Products Analogous to Bacterial Vaccines
C.04.050 Except as provided in this Division, a bacterial vaccine shall be a sterile suspension of killed cultures of bacteria, with or without the addition of other medication, and shall not include an autogenous vaccine.
C.04.051 No person shall sell a bacterial vaccine unless the culture that has been used in its preparation has been tested by an acceptable method for identity and purity and when so tested it shall be true to name and a pure strain, and a record of the culture shall be maintained which shall include a statement of its origin, properties and characteristics.
C.04.052 No fabricator shall use a substrate (culture medium), in the production of a bacterial vaccine, that contains any horse meat or horse serum.
C.04.053 A fabricator of a bacterial vaccine prepared from a bacterium that does not grow readily in ordinary culture media shall test its sterility in media which are specially favourable to the growth of such bacterium, and it shall be sterile.
C.04.054 Except as provided in sections C.04.083, C.04.084 and C.04.090, both the inner and outer labels of every multiple-dose container and the outer label of every single-dose container of a bacterial vaccine shall carry a statement of
(a) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre,
(b) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre, of each species or immunogenic type for a vaccine that contains a number of different species or immunogenic types of bacteria,
(c) the exact nature and amount of any substance, other than a simple diluent, combined with such vaccine, and
(d) the recommended dose,
and the inner label of a single-dose container shall carry a statement that it contains only one dose.
C.04.055 The expiration date of a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue.
Typhoid Vaccine
C.04.060 Cultures of Salmonella typhosa used in the preparation of typhoid vaccine shall be smooth, motile, and in the Vi form, with the following antigenic structure IX,XII,Vi; d.-.
C.04.061 No person shall sell any lot of typhoid vaccine unless such lot has been shown to meet a test for potency made by an acceptable method.
Pertussis Vaccine
C.04.065 A fabricator shall, in the preparation of pertussis (whooping cough) vaccine, use only strains of Bordetella pertussis that meet the requirements of an antigenic test made by an acceptable method.
C.04.066 No person shall sell any lot of pertussis (whooping cough) vaccine unless such lot has been shown to meet a test for potency made by an acceptable method.
B.C.G. (Bacille Calmette-Guerin) Vaccine
C.04.070 B.C.G. vaccine shall be prepared from living B.C.G. organisms that
(a) have been obtained directly from a source approved by the Director;
(b) are proved to be non-pathogenic by an acceptable method; and
(c) have a history of successful use in the production of B.C.G. vaccine.
C.04.071 No fabricator shall employ any person in the manufacture of B.C.G. vaccine unless such person
(a) has been and remains free from all forms of tuberculous infection,
(b) undergoes every six months a medical examination, that shall include an X-ray examination of the chest, for the presence of tuberculosis, such examination being made by a qualified, practising physician who shall sign a certificate of such person’s freedom from tuberculosis, and such certificate shall be kept on file and be available at all times, and
(c) resides in a household that is at all times free from active tuberculosis,
nor shall a fabricator employ such person in any other laboratory position.
C.04.072 The preparation, preservation and packaging/labelling of B.C.G. vaccine shall be conducted under the direct supervision of an experienced bacteriologist who has
(a) not less than three years postgraduate training in bacteriology and immunology;
(b) specialized in the field of bacteriology; and
(c) at least one year of practical experience in the manufacture of B.C.G. vaccine.
C.04.073 No fabricator shall permit any culture that is not a B.C.G. culture to be at any time on any premises that are used for the manufacture of B.C.G. vaccine.
C.04.074 A packager/labeller shall test by an acceptable method, after filling of the final container, each lot of B.C.G. vaccine for the presence of contaminating micro-organisms and when so tested it shall be free therefrom.
C.04.075 Notwithstanding section C.04.074, a fluid B.C.G. vaccine may be released for sale if no growth has appeared upon the test culture medium after an incubation of 24 hours, but if there is evidence of the presence of contaminating micro-organisms in any lot during the test period of 10 days the packager/labeller shall at once recall such lot.
C.04.076 Every fabricator and packager/labeller shall determine the number of viable B.C.G. organisms in each lot of vaccine by an acceptable method and shall keep a record of the number.
C.04.077 A fabricator of B.C.G. vaccine shall keep, at a temperature not exceeding 5.0°C, and for not less than six months,
(a) the culture on glycerine-water potato medium from which the Sauton I and Sauton II subcultures were made, and
(b) not less than six vials of the final product
from each lot thereof.
C.04.078 Every fabricator and packager/labeller of B.C.G. vaccine shall keep, in form satisfactory to the Minister, continuous clinical records of the use of B.C.G. vaccine in humans.
C.04.079 A fabricator of B.C.G. vaccine shall examine pathologically all test animals used and shall immediately report to the Minister any evidence of active, progressive tuberculosis in any such animals.
C.04.080 The expiration date for B.C.G. vaccine shall be not more than
(a) 10 days after harvesting in the case of fluid vaccine;
(b) 12 months after harvesting in the case of freeze dried vaccine stored at a temperature of 4°C or above; or
(c) 20 months after harvesting in the case of freeze dried vaccine stored at a temperature below 4°C.
C.04.081 No person shall sell fluid B.C.G. vaccine that is not packaged in containers sealed by fusion.
C.04.082 No inner label shall be required for fluid B.C.G. vaccine in single-dose containers.
C.04.083 The label of fluid B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of
(a) the weight of bacteria per millilitre; and
(b) the route of administration of the vaccine.
C.04.084 The label of freeze-dried B.C.G. vaccine shall carry, in lieu of the statements provided in paragraphs C.04.054(a) and (b), a statement of
(a) the amount of bacteria per vial or per dose; and
(b) the route of administration of the vaccine.
C.04.085 The provisions of subparagraph C.04.019(b)(iv) do not apply to freeze-dried B.C.G. vaccine.
Products Analogous to Bacterial Vaccines
C.04.090 A product analogous to a bacterial vaccine shall be
(a) a bacterial antigen, other than a bacterial vaccine, such as a lysate, or
(b) an extract prepared from a bacterial culture,
and shall conform to the requirements of these Regulations for bacterial vaccines except those of paragraphs (a) and (b) of C.04.054.
C.04.091 The expiration date of a product analogous to a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue, but for dried tuberculin and tuberculin containing at least 50 per cent glycerin the expiration date shall be not later than five years after the date of manufacture or the date of issue, and for all other tuberculins not more than 12 months after the date of manufacture or the date of issue.
Virus and Rickettsial Vaccines
C.04.100 A virus vaccine, rickettsial vaccine, shall be a suspension of, or prepared from, living or killed viruses or rickettsiae.
C.04.101 No person shall sell a virus or a rickettsial vaccine unless the fabricator has submitted to the Minister details of the source of the strains of viruses or rickettsiae used, the method of their propagation, the method of fabrication of the vaccine, the methods employed for determining sterility, safety, identity and potency and any other tests required by these Regulations.
C.04.102 Upon written request from the Director every fabricator and packager/labeller shall submit with respect to each lot of virus or rickettsial vaccine, when ready for sale, detailed protocols of sterility, safety, identity, potency, and of any other tests required by these Regulations.
Smallpox Vaccine
C.04.110 Smallpox vaccine
(a) shall be a virus vaccine;
(b) shall be the living virus of vaccinia or its derivatives obtained from
(i) the vesicles produced in the skin of healthy calves by inoculation of vaccinia virus,
(ii) specifically infected membranes of chick embryos, or
(iii) suitable tissue culture infected with vaccinia virus or its derivatives; and
(c) shall be in fluid or dried form.
C.04.111 Every fabricator and packager/labeller shall fabricate and package/label smallpox vaccine only in an independent unit that is isolated from all other laboratory activities, and in or about which no extraneous materials are permitted or stored.
C.04.112 A fabricator shall exclude the personnel who care for the vaccine animals from horse stables and paddocks and from contact with horses while smallpox vaccine is being propagated.
C.04.113 Every fabricator and packager/labeller shall dispense smallpox vaccine only in sterile glass containers that are sealed under aseptic conditions.
C.04.114 Every fabricator and packager/labeller shall test smallpox vaccine to establish that it is free from
(a) spore-forming anaerobic micro-organisms;
(b) coagulase positive staphylococci;
(c) haemolytic streptococci; and
(d) any other contaminating pathogenic micro-organisms.
C.04.115 Smallpox vaccine, when tested by acceptable methods,
(a) shall be free from extraneous micro-organisms, in the case of vaccine prepared for use by jet gun; and
(b) shall contain not more than 500 viable non-pathogenic bacteria per millilitre, in the case of vaccine prepared for use by the multiple pressure technique or by scarification.
C.04.116 Smallpox vaccine must demonstrate evidence of disease prevention that is at least equivalent to that of a vaccine that
(a) is known to prevent human to human transmission of smallpox; and
(b) meets the potency of equal to or greater than 108 pockforming units per millilitre, as determined using chick embryo chorioallantoic membranes.
C.04.117 No person shall sell smallpox vaccine unless
(a) in the case of fluid vaccine, it has been stored at a temperature below -10°C;
(b) in the case of dried vaccine, it has been stored at a temperature below 10°C; and
(c) the outer label carries a statement that it shall be stored at a temperature of not more than 5°C.
C.04.118 Notwithstanding the provisions of section C.04.003, the date of issue of smallpox vaccine shall be not later than
(a) in the case of fluid vaccine, nine months after the date of manufacture; and
(b) in the case of dried vaccine, 24 months after the date of manufacture.
C.04.119 The expiration date of smallpox vaccine shall not exceed the following, unless supported by evidence of stability satisfactory to the Minister:
(a) in the case of fluid vaccine, 3 months after the date of issue; or
(b) in the case of dried vaccine, 12 months after the date of issue.
C.04.120 No inner label shall be required for smallpox vaccine in single-dose containers or when dispensed in capillary tubes.
C.04.121 No person shall sell smallpox vaccine to which an antibiotic has been added.
Poliomyelitis Vaccine
C.04.122 Poliomyelitis vaccine shall be an aqueous suspension of killed poliomyelitis viruses, Types I, II, and III.
C.04.123 Poliomyelitis vaccine shall be prepared in acceptable tissue culture medium from strains of poliomyelitis virus proven capable of producing vaccine of acceptable potency.
C.04.124 Poliomyelitis vaccine in its final form shall contain not more than 0.35 milligram per millilitre of total nitrogen, nor more than one part per million of animal serum.
C.04.125 No person shall sell poliomyelitis vaccine unless it has been tested by an acceptable method for potency and safety and when so tested it shall be safe and of acceptable potency.
C.04.126 The outer label shall carry a statement of any antibiotic present in the vaccine.
C.04.127 The expiration date of the poliomyelitis vaccine shall be not later than 12 months after the date of the last satisfactory potency test unless evidence, satisfactory to the Director, is presented that a longer period is appropriate.
Poliovirus Vaccine, Live, Oral
C.04.128 Poliovirus Vaccine, Live, Oral or Poliovirus Vaccine, Live, Oral (Naming the strains) shall be prepared from living poliomyelitis virus types I, II and III that
(a) have been obtained directly from a source acceptable to the Director;
(b) are shown to be genetically stable by an acceptable method;
(c) are shown to be non-pathogenic when given orally to humans;
(d) are proved to be capable of multiplying in the human alimentary tract and of producing type specific neutralizing antibodies when administered orally; and
(e) have a history of successful use in the production of polio-virus vaccine, live, oral.
C.04.129 Poliovirus vaccine, live, oral, shall be fabricated, packaged/labelled and tested in premises separated from buildings where other products are fabricated, packaged/labelled or tested, and from buildings where control tests involving the use of cell lines or virus strains not employed in the fabrication, packaging/labelling and testing of poliovirus vaccine, live, oral, are carried out.
C.04.130 No fabricator shall permit the introduction of any bacterial or viral cultures other than those used in the manufacture of poliovirus vaccine, live, oral on any premises that are used for the manufacture of poliovirus vaccine, live, oral.
C.04.131 Notwithstanding sections C.04.129 and C.04.130, a fabricator may manufacture other drugs in an area in which polio-virus vaccine, live, oral is manufactured at times when that vaccine is not being manufactured, if
(a) both prior to and following each manufacture the area is cleaned and disinfected by methods acceptable to the Director; and
(b) the fabricator has received written permission from the Director to carry out such manufacture.
C.04.132 Poliovirus vaccine, live, oral shall be prepared only
(a) in a tissue culture,
(b) in a medium, and
(c) by methods
acceptable to the Director.
C.04.133 No fabricator shall sell poliovirus vaccine, live, oral, unless he has tested each lot for extraneous micro-organisms and the vaccine is free therefrom.
C.04.134 A fabricator of poliovirus vaccine, live, oral shall test, by a method acceptable to the Director, each lot of vaccine for neurovirulence and for genetic markers and it shall meet the requirements established by the Director.
C.04.135 No fabricator shall employ any person in the manufacture of poliovirus vaccine, live, oral unless such person
(a) is free from infectious disease;
(b) has been vaccinated successfully against poliomyelitis by poliovirus vaccine, live, oral; and
(c) has been proved by periodic tests to be a non-carrier of poliomyelitis virus.
C.04.136 A fabricator of poliovirus vaccine, live, oral shall not permit the entry to a building in which the vaccine is manufactured of any person who
(a) is not directly concerned with the manufacturing processes; or
(b) has been working on the same day with experimental animals or with infectious agents.
Bacteriophage
C.04.137 Bacteriophage shall be a virus preparation with specific lytic action against micro-organisms actually or potentially pathogenic.
C.04.138 The expiration date of bacteriophage shall be not later than 12 months after the date of manufacture or the date of issue.
Toxins, Toxoids
Schick Test Reagents
C.04.140 Schick test reagents for the diagnosis of susceptibility to diphtheria shall be
(a) diphtheria toxin for Schick test;
(b) Schick control; and
(c) diphtheria toxin for Schick test with control.
C.04.141 Diphtheria toxin for Schick test shall be sterile diluted diphtheria toxin stabilized by an acceptable method.
C.04.142 Schick control shall be suitably diluted
(a) diphtheria toxoid; or
(b) sterile diphtheria toxin heated at a temperature of 95°C for five minutes.
C.04.143 The human test dose of diphtheria toxin for Schick test, when aged toxin containing a preservative is used, shall be determined by
(a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction but mixed with 1/1,250 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction”; and
(b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/50 of one test dose must not cause, and 1/25 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.
C.04.144 The human test dose of diphtheria toxin for Schick test, when fresh toxin containing no preservative is used, shall be determined by
(a) intracutaneous injection into normal guinea pigs in mixtures with different proportions of diphtheria antitoxin, and one test dose mixed with 1/750 or more of a unit of antitoxin must cause no local reaction, but mixed with 1/1,500 or less of a unit of antitoxin must cause a definite local reaction of the type known as the “positive Schick reaction”; and
(b) intracutaneous injection into normal guinea pigs without admixture with antitoxin, and 1/100 of one test dose must not cause, and 1/50 of one test dose must cause, a definite local reaction of the type known as the “positive Schick reaction”.
C.04.145 The human test dose for the Schick control shall give a negative Schick reaction when injected intracutaneously into normal guinea pigs.
C.04.146 No person shall sell diphtheria toxin for Schick test unless both the inner and the outer labels carry a statement of the number of human test doses it contains together with the name of any stabilizer.
C.04.147 The expiration date of Schick test reagents for the diagnosis of susceptibility to diphtheria shall be not later than 12 months after the date of manufacture or the date of issue.
Diphtheria Toxoid
C.04.160 Liquid diphtheria toxoid shall be sterile, formalized, detoxified diphtheria toxin and shall not contain more than 0.02 per cent free formaldehyde.
C.04.161 Diphtheria toxoid alum precipitated shall be prepared from diphtheria toxoid, and shall not contain more than 15 milligrams of alum per human dose.
C.04.162 The alum used in the preparation of diphtheria toxoid alum precipitated shall contain not less than 99.5 per cent pure potassium alum, Al K(SO4)2,12H2O.
C.04.163 No fabricator shall use a culture medium for the production of diphtheria toxin that contains horse protein or Witte peptone or that has not been freed as far as possible from any other allergenic ingredient.
C.04.164 Diphtheria toxin from which diphtheria toxoid is prepared shall have a toxicity, as indicated by an L+dose, of not more than 0.20 millilitre or by an M.L.D. of not more than 0.0025 millilitre.
C.04.165 A fabricator shall test each bulk container of diphtheria toxoid, before being dispensed into the final containers, for toxicity by an acceptable method, and it shall be non-toxic.
C.04.166 No person shall sell any lot of diphtheria toxoid unless such lot has been shown to meet a test for antigenicity made by an acceptable method.
C.04.167 A fabricator shall fill diphtheria toxoid aseptically into clear glass containers and where preservative is not added shall seal the containers by fusion.
C.04.168 No person shall sell diphtheria toxoid that contains phenol.
C.04.169 No person shall sell diphtheria toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization.
C.04.170 The expiration date of diphtheria toxoid shall be not later than two years after the date of manufacture or the date of issue.
Tetanus Toxoid
C.04.180 Liquid tetanus toxoid shall be sterile, formalized, detoxified tetanus toxin, and shall not contain more than 0.02 per cent free formaldehyde.
C.04.181 Tetanus toxoid alum precipitated shall be prepared from tetanus toxoid, and shall not contain more than 15 milligrams of alum per human dose.
C.04.182 The alum used in the preparation of tetanus toxoid alum precipitated shall contain not less than 99.5 per cent pure potassium alum, Al K(SO4)2, 12H2O.
C.04.183 No fabricator shall use a culture medium for the production of tetanus toxin that contains horse protein or Witte peptone or that has not been freed as far as possible from any other allergenic ingredient.
C.04.184 Tetanus toxin from which tetanus toxoid is prepared shall have a toxicity as indicated by an M.L.D. for the guinea pig of not more than 0.0001 millilitre.
C.04.185 A packager/labeller shall test each bulk container of tetanus toxoid, before being dispensed into the final containers, for toxicity by an acceptable method, and it shall be non-toxic.
C.04.186 No person shall sell any lot of tetanus toxoid unless such lot has been shown to meet a test for antigenicity made by an acceptable method.
C.04.187 No person shall sell tetanus toxoid unless both the inner and the outer labels carry a statement of the appropriate dose for purposes of immunization.
C.04.188 A fabricator shall fill tetanus toxoid aseptically into clear glass containers and where a preservative is not added shall seal the container by fusion.
C.04.189 No person shall sell tetanus toxoid that contains phenol.
C.04.190 The expiration date of tetanus toxoid shall be not later than two years after the date of manufacture or the date of issue.
Antitoxins, Antisera
C.04.210 An antitoxin or antiserum shall be the serum or fraction thereof separated from the blood of animals that have been artificially immunized against the by-products or antigenic fractions of specific cultures of micro-organisms, or against specific venoms.
C.04.211 The potency of an antitoxin or antiserum shall be determined by an acceptable method and where applicable the unit of potency shall be the International Unit.
C.04.212 Liquid diphtheria antitoxin shall have a potency of not less than 500 International Units per millilitre.
C.04.213 Liquid tetanus antitoxin shall have a potency of not less than 400 International Units per millilitre.
C.04.214 A liquid antitoxin or antiserum shall contain not more than 20 per cent solids.
C.04.215 A dried antitoxin shall be prepared from a liquid antitoxin and, when reconstituted to the original volume of the liquid antitoxin, shall have a potency not less than that prescribed for such liquid antitoxin.
C.04.216 A dried antitoxin or antiserum shall not contain more than one per cent moisture when determined by an acceptable method.
C.04.217 Each lot of antitoxin or antiserum shall be tested by an acceptable method for pyrogenicity and it shall be pyrogen-free, and, after filling into the final containers, for identity and it shall be true to name.
C.04.218 No person shall sell an antitoxin or antiserum unless both the inner and the outer labels carry a statement of the species of animal used, when other than the horse, and the net contents in millilitres or the number of units in the container.
C.04.219 In respect of antitoxins, the expiration date shall be
(a) for liquid antitoxins with standards of potency, not later than five years after the date of manufacture;
(b) for dried antitoxins with standards of potency, not later than five years after the date of manufacture;
(c) for liquid antioxins with no standards of potency, not later than 12 months after the date of manufacture; and
(d) for dried antitoxins with no standards of potency, not later than five years after the date of manufacture.
C.04.220 In respect of antisera, the expiration date shall be
(a) for liquid antisera with standards of potency, not later than three years after the date of manufacture;
(b) for dried antisera with standards of potency, not later than five years after the date of manufacture;
(c) for liquid antisera with no standards of potency, not later than 12 months after the date of manufacture; and
(d) for dried antisera with no standards of potency, not later than five years after the date of manufacture.
Preparations from Human Sources
C.04.230 Preparations from human sources shall be pooled blood plasma, or pooled blood serum, or fractions of either separated by a method satisfactory to the Minister.
C.04.231 A fabricator shall obtain human serum, or human plasma, only from a person certified by a qualified medical practitioner to be healthy.
C.04.232 A fabricator shall not use a person to serve as a donor of blood, placenta, or cord who has a history of a disease transmissible by blood transfusion including syphilis, infectious hepatitis, or malaria.
C.04.233 The operation of drawing blood from a donor shall be under the supervision of a qualified medical practitioner, and shall be carried out in a suitable bleeding room under the control of the fabricator.
C.04.234 A fabricator shall obtain human placenta and cord used in the manufacture of preparations from human sources only from women confined in public hospitals, and the donor of such placenta and cord shall have been free from the toxaemias of pregnancy, and the placenta and cord shall not show gross evidence of any pathological condition.
C.04.235 (1) Subject to subsections (2) and (3), dried human serum, dried human plasma or dried fractions of either shall not contain more than one per cent moisture when determined by an acceptable method.
(2) Dried Rho(D) Immune Human globulin shall not contain more than three per cent moisture when determined by an acceptable method.
(3) Dried Antihemophilic Factor Human shall not contain more than two per cent moisture when determined by an acceptable method.
C.04.236 A fabricator shall provide directions or means for the removal of particles of such size as to be dangerous to the recipient from preparations from human sources that are issued in fluid form or that are reconstituted from the dried form.
C.04.237 A fabricator of preparations from human sources shall maintain complete records of all donors, which records shall include the medical certificate required by section C.04.231.
C.04.238 A fabricator, packager/labeller or distributor referred to in paragraph C.01A.003(b) may issue human serum or human plasma, or fractions of either of them, for prophylactic or therapeutic use in any of the following forms:
(a) immune human serum, which shall be serum separated from the blood of persons recovered from the disease or from persons specifically immunized against the disease for which the serum is intended as a prophylactic or therapeutic agent;
(b) immune human globulins, or other immune human serum fractions, which shall be prepared from immune human serum or plasma;
(c) normal human serum, or normal human plasma, or fractions of either of these prepared from the blood of normal individuals; and
(d) dried products prepared from any of these.
C.04.239 No person shall sell a preparation from human sources unless both the inner and the outer labels clearly indicate that the preparation is derived from human sources.
C.04.240 The expiration date for preparations from human sources issued in fluid or dried form shall be not later than five years after the date of filling the immediate container.
C.04.241 The date of manufacture of preparations from human sources shall be the date of bleeding the donor.
C.04.300 and C.04.301 [Repealed, SOR/81-335, s. 3]
Human Plasma Collected by Plasmapheresis
Interpretation
C.04.400 In this section and in sections C.04.401 to C.04.428
donor
donor means a donor of blood for plasmapheresis; (donneur)
human plasma
human plasma means the fluid portion of blood that has been collected by plasmapheresis and stabilized against clotting; (plasma humain)
plasmapheresis
plasmapheresis means the process comprising
(a) the withdrawal of blood from a donor,
(b) the separation of the plasma from the red blood cells, and
(c) the return of the red blood cells to the donor; (plasmaphérèse)
practitioner
practitioner means a person registered and licensed under the laws of a province to practise the profession of medicine; (praticien)
red blood cell suspension
red blood cell suspension means red blood cells suspended in sodium chloride solution that have been collected by plasmapheresis and stabilized against clotting. (suspension de globules rouges)
Application
C.04.401 Sections C.04.402 to C.04.428 do not apply to plasmapheresis performed
(a) for the therapy of a donor;
(b) for the procurement of blood constituents for use in only one recipient;
(c) for medical research; or
(d) for the production of blood grouping sera by a hospital for use within the hospital.
Prohibition
C.04.402 No person shall sell or fabricate human plasma or red blood cell suspension except in accordance with sections C.04.403 to C.04.428.
Specific Immunization
C.04.403 (1) Every practitioner shall, before commencing the specific immunization of a donor for the purposes of plasmapheresis,
(a) select the antigen to be injected;
(b) schedule injections of the antigen; and
(c) inform the donor of
(i) the nature of the material to be injected,
(ii) the maximum number of injections to be made,
(iii) the approximate duration of the immunization program, and
(iv) the possible hazards involved.
(2) During the course of every specific immunization program, the practitioner shall
(a) evaluate the donor’s clinical response to the program; and
(b) inject the antigen himself or supervise the injection of the antigen by qualified personnel.
Donor Suitability
C.04.404 (1) Every practitioner shall, within 30 days before carrying out on a donor a procedure in a plasmapheresis program involving collection of plasma at intervals of eight weeks or less,
(a) determine the suitability of the donor for plasmapheresis by means of
(i) the review of the donor’s medical history, and
(ii) such tests and physical examination as the practitioner deems necessary; and
(b) if the practitioner has determined pursuant to paragraph (a) that the donor is suitable for plasmapheresis, sign a certificate to that effect.
(2) Subsection (1) does not apply where a practitioner has, in respect of the donor, signed a certificate referred to in paragraph (1)(b) within the 12-month period preceding the date on which the procedure is to be carried out.
Plasmapheresis
C.04.405 Every practitioner shall, before commencing a plasmapheresis program, inform the donor of the hazards of the program including the risks of a haemolytic reaction.
C.04.406 (1) A donor who has been provided with a signed certificate pursuant to section C.04.404 shall, on the day that plasmapheresis is to be carried out on him, be interviewed and evaluated by a practitioner or, under the supervision of a practitioner, by a person trained for such a purpose, to ensure that the donor is in good health and, without restricting the generality of such interview and evaluation, to ensure that the donor:
(a) has not donated whole blood within the previous eight weeks;
(b) has a normal temperature;
(c) is free from
(i) infection, including any infectious skin disease at the site of phlebotomy, and
(ii) any disease generalized to such an extent as to create a risk of contamination of the human plasma;
(d) is free from any disease transmissible by blood transfusion;
(e) is free from skin punctures or scars on the arms and forearms indicative of drug addiction;
(f) has a blood pressure within normal limits;
(g) has a
(i) blood hemoglobin level of not less than 125 grams per litre of blood if the donor is female or 135 grams per litre of blood if the donor is male, or
(ii) a hematocrit value of 0.38 litre/litre of blood if the donor is female or 0.41 litre/litre if the donor is male;
(h) has a total serum protein of not less than 60 grams per litre of serum;
(i) weighs at least 40 kilograms;
(j) has no history of viral hepatitis;
(k) has not, within the last six months, been in close contact with an individual suffering from viral hepatitis; and
(l) has not, within the last six months, received human blood or any derivative of human blood that is a possible source of viral hepatitis, except for specific immunization performed in accordance with section C.04.403.
(2) Notwithstanding paragraph (1)(a), a donor may donate plasma within eight weeks of a previous donation of whole blood, provided he is examined by a practitioner and that practitioner certifies that the donor otherwise meets the criteria in subsection (1) and that the donor may donate plasma.
C.04.407 Any donor who appears to be under the influence of any drug or alcohol or who for any reason does not appear to be providing reliable answers to questions shall not be considered a suitable donor.
Presence of Practitioner
C.04.408 Plasmapheresis shall be performed only during times that a practitioner, who is fully informed about the plasmapheresis procedure, is present on the premises or can attend the donor within 10 minutes of the time the need arises.
Prevention of Contamination
C.04.409 (1) The skin of a donor at the site of phlebotomy shall be prepared thoroughly and carefully by a method that gives maximum assurance of a sterile container of blood.
(2) The blood of the donor shall be collected, the human plasma shall be separated and the red blood cell suspension shall be returned to the donor by aseptic methods in a sterile collection system.
(3) All surfaces that come in contact with blood or human plasma shall be both sterile and pyrogen-free.
(4) Equipment and waste materials contaminated with blood or human plasma shall be removed immediately following usage for incineration or disinfection.
(5) Any spillage of blood or human plasma shall be treated as a potential source of infection and the area shall be decontaminated immediately.
Samples
C.04.410 (1) A sample of blood shall be drawn from each donor within the seven-day period prior to the donor’s first plasmapheresis in a plasmapheresis program and not less frequently than every three months thereafter for so long as the donor continues on the program
(a) by a practitioner; or
(b) under the supervision of a practioner, by a person trained for that purpose.
(2) Every sample drawn pursuant to subsection (1) shall be tested by
(a) a laboratory test for syphilis; and
(b) a serum protein electrophoresis test, a quantitative immunodiffusion test, or another test made by an acceptable method to determine the serum protein components.
(c) [Repealed, SOR/85-1022, s. 5]
(3) Within 14 days after a sample is drawn pursuant to subsection (1), results of the tests specified in subsection (2) shall be reviewed by a practitioner.
(4) Where the test referred to in paragraph (2)(a) is reactive for syphilis, plasmapheresis shall not be carried out again on the donor until the donor’s serum proves nonreactive to a laboratory test for syphilis.
(5) Where the test referred to in paragraph (2)(b) shows the plasma protein composition of a donor not to be within normal limits, the donor shall be removed from the plasmapheresis program until those values return to normal.
Review
C.04.411 At least every three months during every plasmapheresis program, all laboratory data and collection records shall be reviewed by a practitioner to determine the continuing suitability of the donor to remain on the program and the practitioner shall sign the review.
C.04.412 Any donor who is, at any time, found not suitable to remain on a plasmapheresis program shall forthwith be removed from the program.
Identification System
C.04.413 (1) Every fabricator of human plasma shall establish a donor identification system that positively identifies each donor and relates the records and laboratory data of each donor directly to the donor’s blood and its components.
(2) The identification system referred to in subsection (1) shall include the use of a photograph to confirm the donor’s identity or some other method that provides equal assurance of positively identifying the donor.
C.04.414 Each container of blood and human plasma shall be marked or identified by a number or symbol so as to relate it directly to the donor.
Anticoagulant Solution
C.04.415 A pyrogen-free anticoagulant solution shall be used in every plasmapheresis program consisting of one of the following formulae:
(a) Anticoagulant acid citrate dextrose solution (ACD)
Trisodium citrate (Na3C6H5O7.2H2O)22.0 g
Citric acid (C6H8O7.H2O)8.0 g
Dextrose (C6H12O6H2O)24.5 g
Water for Injection (U.S.P.) to make1 000.0 mL
(b) Anticoagulant citrate phosphate dextrose solution (CPD)
Trisodium citrate (Na3C6H5O7.2H2O)26.3 g
Citric acid (C6H8O7.H2O)3.3 g
Dextrose (C6H12O6H2O)25.5 g
Monobasic sodium phosphate (NaH2PO4H2O)2.2 g
Water for Injection (U.S.P.) to make1 000.0 mL
(c) Anticoagulant citrate phosphate dextrose adenine solution (CPDA-I)
Trisodium citrate (Na3C6H5O7.2H2O)26.3 g
Citric acid (C6H8O7.H2O)3.3 g
Dextrose (C6H12O6H2O)31.9 g
Monobasic sodium phosphate (NaH2PO4H2O)2.2 g
Adenine (C5H5N5)275.0 mg
Water for Injection (U.S.P.) to make1 000.0 mL
(d) Anticoagulant sodium citrate solution (SC)
Trisodium citrate (Na3C6H5O7.2H2O)40.0 g
Water for Injection (U.S.P.) to make1 000.0 mL
Limitations on Plasmapheresis
C.04.416 (1) The maximum quantity of whole blood that may be collected by plasmapheresis from a donor at one time is
(a) where the donor’s weight is 40 kg or more but not more than 50 kg, 9 mL per kg of body weight;
(b) where the donor’s weight is more than 50 kg but not more than 80 kg, 500 mL; or
(c) where the donor’s weight is more than 80 kg, 600 mL.
(2) The maximum feasible volume of red blood cell suspension shall be returned to a donor before another unit of whole blood is collected from him.
(3) If the red blood cell suspension of the first collection of whole blood cannot be returned to the donor, then no further collection of blood shall be made for three months.
(4) No more than two donations of plasma shall be collected from a donor within any 48-hour period.
(5) No more than four donations of plasma shall be collected from a donor within any seven-day period.
(6) The maximum quantity of whole blood, not including anticoagulant, that may be collected by plasmapheresis from a donor within any six-month period is
(a) where the donor’s weight is less than 50 kg, 19 L;
(b) where the donor’s weight is 50 kg or more but not more than 80 kg, 26 L;
(c) where the donor’s weight is more than 80 kg, 31 L.
Collection
C.04.417 (1) All blood for human plasma shall be collected from a donor
(a) by a practitioner; or
(b) under the supervision of a practitioner, by a person trained in the procedure of blood collection.
(2) The human plasma shall, immediately after each blood collection, be separated from the red blood cells.
(3) Sodium Chloride for injection, when used to return blood cell suspension to a donor, shall be obtained from a previously unused container.
General Requirements
Test for Hepatitis B Antigen
C.04.418 Each unit of human plasma shall be nonreactive to a test for the hepatitis B antigen as determined by an acceptable method.
Processing
C.04.419 Notwithstanding section C.04.406(j), (k) and (l) and section C.04.418, plasmapheresis may be conducted on a donor whose plasma is reactive to hepatitis B surface antigen or anti-hepatitis B surface antigen to obtain plasma for production of hepatitis B vaccine, hepatitis B immune globulin or for in vitro diagnostic reagents if specific written authorization for such activity has been provided by the Minister.
Containers
C.04.420 (1) Containers used for human plasma, whether integrally attached or separated from the original blood container, shall not be entered by the fabricator for any purpose except for filling with human plasma.
(2) Containers used for human plasma shall be uncoloured and hermetically sealed and shall permit clear visibility of the contents.
(3) Containers and their components used for human plasma shall not interact with the plasma under normal conditions of storage and use so as to alter the safety, quality, purity or potency of the plasma and shall provide adequate protection against external factors that may cause deterioration or contamination.
(4) Containers used for human plasma shall, before being filled, be marked or identified by a number or some other symbol that will relate it directly to the donor.
(5) Containers for human plasma collected from a donor referred to in section C.04.419 shall, after being filled, be handled, stored and packaged separately from other containers.
C.04.421 Human plasma shall not contain a preservative.
C.04.422 No container of human plasma shall contain more than one collection of human plasma.
C.04.423 Any container that is filled with human plasma shall be stored forthwith at -20°C or colder unless the human plasma is intended for the manufacture of reagents.
C.04.424 Human plasma that is frozen shall be inspected at the time of sale and, if there is any evidence of thawing, the unit shall not be sold.
C.04.425 If pilot samples of human plasma are provided, they shall meet the following standards:
(a) prior to filling, all containers of pilot samples shall be marked or labelled so as to relate them directly to the donor of that unit of plasma;
(b) all containers of pilot samples shall be filled at the time the final product is prepared by the person who prepares the final product;
(c) all pilot samples shall be representative of the contents of the final product; and
(d) all pilot samples shall be collected in a manner that does not contaminate the contents of the container.
C.04.426 (1) The labelling provisions of sections C.01.004 and C.04.019 do not apply to human plasma or pilot samples thereof.
(2) In addition to complying with section C.04.414, each container of human plasma, other than a container of a pilot sample, shall be labelled with the following information:
(a) the proper name of the product;
(b) the name, address and establishment licence number of the distributor referred to in paragraph C.01A.003(b);
(c) the donor number or symbol;
(d) the collection date of the plasma;
(e) [Repealed, SOR/85-1022, s. 11]
(f) the statement: “Store at -20°C or colder” or the appropriate storage temperature where the plasma is intended for the manufacture of reagents;
(g) a statement as to whether the plasma was collected from normal donors or from donors specifically immunized;
(h) the immunizing antigen, if applicable;
(i) the total volume or weight of plasma;
(j) the total quantity and type of anticoagulant used in the plasmapheresis procedure; and
(k) the test for hepatitis B antigen used and the results thereof.
(3) The label of each container used for human plasma that is collected pursuant to section C.04.419 shall bear conspicuous statements that the product may transmit viral hepatitis and that it is to be used for manufacturing purposes only.
Manufacturing Responsibility
C.04.427 [Repealed, SOR/97-12, s. 50]
Records
C.04.428 (1) In addition to the general record keeping requirements of this Division, every fabricator of human plasma shall keep for each donor
(a) a record of the specific immunization program carried out for the purposes of plasmapheresis, where applicable; and
(b) a complete record of
(i) all examinations, evaluations and reviews required by sections C.04.404, C.04.406, C.04.407 and C.04.411,
(ii) all tests carried out, and
(iii) all interviews conducted.
(2) Each donor record shall be cross-referenced to the units of human plasma associated with the donor.
Insulin Preparations
C.04.550 (1) Insulin means the active principle of the pancreas that affects the metabolism of carbohydrates in the animal body and that is of value in the treatment of diabetes mellitus.
(2) The Canadian Reference Standard for insulin shall be the International Standard therefor.
(3) The insulin preparations described in these Regulations shall contain insulin to which may be added only such ingredients as are prescribed in these Regulations.
(4) The potency of an insulin preparation shall be expressed in units per cubic centimetre and each unit per cubic centimetre shall provide one International Unit of insulin per cubic centimetre.
C.04.551 No person shall sell or dispense an insulin preparation that has not been stored by him continuously at a temperature between 35° and 50°F (2° and 10°C).
C.04.552 The zinc-insulin crystals used in an insulin preparation shall contain, as determined by an acceptable method,
(a) not less than 21 International Units of insulin per milligram, and
(b) on the dry basis, not less than 0.30 per cent and not more than 0.90 per cent zinc.
Insulin Injection or Insulin
C.04.553 The insulin preparation, “Insulin injection” or “Insulin” shall be a clear colourless or almost colourless sterile solution free from turbidity and insoluble matter, prepared from insulin or zinc insulin crystals, shall have a pH of not less than 2.5 or more than 3.5, or not less than 7.0 or more than 7.8 and shall contain
(a) weight by volume,
(i) not less than 0.1 per cent and not more than 0.25 per cent of either phenol or cresol, and
(ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin; and
(b) as determined by an acceptable method, for each 1,000 International Units of insulin,
(i) not more than 7.0 milligrams of nitrogen for Insulin Injection prepared from zinc-insulin crystals, and not more than 8.5 milligrams of nitrogen for Insulin Injection other than that made from zinc-insulin crystals,
(ii) not less than 0.10 milligram and not more than 0.40 milligram of zinc for Insulin Injection prepared from zinc-insulin crystals, and not more than 0.40 milligram of zinc for Insulin Injection other than that made from zinc-insulin crystals, and
(iii) in the case of Insulin Injection other than that made from zinc-insulin crystals, not more than 1.0 milligram of ash.
C.04.554 No person shall sell Insulin Injection unless,
(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres;
(b) the vial label indicates that each cubic centimetre has a potency equal to
(i) 40 International Units of insulin,
(ii) 80 International Units of insulin, or
(iii) 100 International Units of insulin; and
(c) each cubic centimetre thereof has an actual potency that is at least 95 per cent and does not exceed 105 per cent of the potency indicated on the label as determined by an acceptable method.
C.04.555 (1) A fabricator shall not sell Insulin Injection unless he
(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;
(b) has furnished the Director with such additional information as the Director may require; and
(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.
(2) A submission filed pursuant to subsection (1) shall include at least,
(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Injection
(i) protocols of assay of its potency expressed in International Units per cubic centimetre, in the case of insulin, and in International Units per milligram, in the case of zinc-insulin crystals,
(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals,
(iii) a report of the ash content in the case of insulin, and
(iv) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;
(b) for the first finished lot of Insulin Injection prepared from each master lot of insulin or zinc-insulin crystals, a report on the amount of each component thereof; and
(c) for the first filling of the first finished lot of Insulin Injection from each master lot of insulin or zinc-insulin crystals,
(i) a report of assay of its nitrogen content in milligrams per 1,000 International Units of insulin,
(ii) a report of assay of its zinc content in milligrams per 1,000 International Units of insulin, and
(iii) a report on the determination of its pH.
(iv) [Repealed, SOR/95-203, s. 2]
C.04.556 The expiration date printed on the inner and outer labels of every package of Insulin Injection shall be a date not later than two years after the date of removal for distribution from the fabricator’s place of storage.
Insulin Zinc Suspension—Rapid
C.04.557 The insulin preparation “Insulin Zinc Suspension — Rapid” shall be a sterile suspension in a buffered aqueous medium, of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain,
(a) weight by volume,
(i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2.3H2O),
(ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and
(iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and
(b) as determined by an acceptable method, for each 1,000 International Units of insulin,
(i) not more than 7.0 milligrams of nitrogen; and
(ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid.
C.04.558 The insulin used in the preparation of Insulin Zinc Suspension — Rapid shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of Insulin Zinc Suspension-Rapid when the precipitate is suspended uniformly.
C.04.559 The clear supernatant liquid obtained from Insulin Zinc Suspension — Rapid shall contain not more than 1.0 International Unit of Insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method.
C.04.560 No person shall sell Insulin Zinc Suspension — Rapid unless
(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and
(b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly,
(i) 40 International Units of insulin,
(ii) 80 International Units of insulin, or
(iii) 100 International Units of insulin.
C.04.561 (1) A fabricator shall not sell Insulin Zinc Suspension — Rapid unless he
(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;
(b) has furnished the Director such additional information as the Director may require; and
(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.
(2) A submission filed pursuant to subsection (1) shall include at least,
(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension — Rapid,
(i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,
(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and
(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;
(b) for the first finished lot of Insulin Zinc Suspension — Rapid prepared from each master lot of insulin or zinc-insulin crystals
(i) a report on the amount of each component used in the preparation,
(ii) a report of assay of its nitrogen content per 1,000 International Units of insulin,
(iii) a report of assay of its zinc content per 1,000 International Units of insulin,
(iv) a report of the insulin content in International Units per cubic centimetre of the supernatant liquid after removal of the suspended precipitate,
(v) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate,
(vi) a report on the determination of its pH, and
(vii) a report on the microscopic appearance of the suspended precipitate; and
(c) for the first filling of the first finished lot of Insulin Zinc Suspension — Rapid from each master lot of insulin or zinc-insulin crystals,
(i) a report on the determination of its pH,
(ii) a report on the microscopic examination of the precipitate, and
(iii) a report on its identification, as determined by an acceptable method.
(iv) [Repealed, SOR/95-203, s. 3]
C.04.562 The expiration date printed on the inner and outer labels of every package of Insulin Zinc Suspension — Rapid shall be a date not later than two years after the date of filling of the immediate container.
Insulin Zinc Suspension—Medium
C.04.563 The insulin preparation “Insulin Zinc Suspension — Medium” shall be a sterile suspension, in a buffered aqueous medium, of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of a mixture of crystals and amorphous material in an approximate ratio of seven parts of crystals to three parts of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain,
(a) weight by volume,
(i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2.3H2O),
(ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and
(iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and
(b) as determined by an acceptable method, for each 1,000 International Units of insulin,
(i) not more than 7.0 milligrams of nitrogen of which not less than 63 per cent and not more than 73 per cent shall be in the crystalline component, and
(ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid.
C.04.564 The insulin used in the preparation of Insulin Zinc Suspension — Medium shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly.
C.04.565 The clear supernatant liquid obtained from Insulin Zinc Suspension — Medium shall contain not more than 1.0 International Unit of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method.
C.04.566 No person shall sell Insulin Zinc Suspension-Medium unless
(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and
(b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly,
(i) 40 International Units of insulin,
(ii) 80 International Units of insulin, or
(iii) 100 International Units of insulin.
C.04.567 (1) A fabricator shall not sell Insulin Zinc Suspension-Medium unless he
(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;
(b) has furnished the Director with such additional information as the Director may require; and
(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.
(2) A submission filed pursuant to subsection (1) shall include at least,
(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension-Medium,
(i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,
(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and
(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;
(b) for the first finished lot of Insulin Zinc Suspension-Medium prepared from each master lot of insulin or zinc-insulin crystals,
(i) a report on the amount of each component used in the preparation,
(ii) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(iii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(iv) a report of the insulin content, in International Units per cubic centimetre, of the supernatant liquid after removal of the suspended precipitate,
(v) a report on the determination of the proportion of the nitrogen in the crystalline component of the suspended precipitate,
(vi) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate,
(vii) a report on the determination of its pH, and
(viii) a report on the microscopic appearance of the suspended precipitate; and
(c) for the first filling of the first finished lot of Insulin Zinc Suspension — Medium from each master lot of insulin or zinc-insulin crystals,
(i) a report on the determination of its pH,
(ii) a report on the microscopic examination of the precipitate, and
(iii) a report on its identification as determined by an acceptable method.
(iv) [Repealed, SOR/95-203, s. 4]
C.04.568 The expiration date printed on the inner and outer labels of Insulin Zinc Suspension — Medium shall be a date not later than two years after the date of filling of the immediate container.
Insulin Zinc Suspension—Prolonged
C.04.569 The insulin preparation “Insulin Zinc Suspension — Prolonged” shall be a sterile suspension in a buffered aqueous medium of insulin modified by the addition of zinc in such a way that the suspended precipitate consists of crystals with not more than a trace of amorphous material, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain
(a) weight by volume,
(i) not less than 0.15 per cent and not more than 0.17 per cent of sodium acetate (NaC2H3O2.3H2O),
(ii) not less than 0.65 per cent and not more than 0.75 per cent of sodium chloride, and
(iii) not less than 0.09 per cent and not more than 0.11 per cent of methyl-p-hydroxybenzoate; and
(b) as determined by an acceptable method, for each 1,000 International Units of insulin,
(i) not more than 7.0 milligrams of nitrogen, of which not less than 90 per cent shall be in the crystalline component, and
(ii) not less than 1.2 milligrams and not more than 2.5 milligrams of zinc, of which not less than 20 per cent and not more than 65 per cent shall be in the supernatant liquid.
C.04.570 The insulin used in the preparation of Insulin Zinc Suspension — Prolonged shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly.
C.04.571 The clear supernatant liquid obtained from Insulin Zinc Suspension — Prolonged shall contain not more than 1.0 International Unit of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, and not more than 1.5 International Units of insulin per cubic centimetre when the potency of the insulin preparation is either 80 units or 100 units per cubic centimetre, as determined by an acceptable method.
C.04.572 No person shall sell Insulin Zinc Suspension — Prolonged unless
(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and
(b) each cubic centimetre thereof provides, when the precipitate is suspended uniformly,
(i) 40 International Units of insulin,
(ii) 80 International Units of insulin, or
(iii) 100 International Units of insulin.
C.04.573 (1) A fabricator shall not sell Insulin Zinc Suspension — Prolonged unless he
(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;
(b) has furnished the Director with such additional information as the Director may require; and
(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.
(2) A submission filed pursuant to subsection (1) shall include at least,
(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Insulin Zinc Suspension — Prolonged,
(i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,
(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and
(iii) reports of assay of the nitrogen content in milligrams and of its zinc content in milligrams per 1,000 International Units of insulin;
(b) for the first finished lot of Insulin Zinc Suspension — Prolonged prepared from each master lot of insulin or zinc-insulin crystals,
(i) a report on the amount of each component used in the preparation,
(ii) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(iii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(iv) a report of the insulin content, in International Units per cubic centimetre, of the supernatant liquid after removal of the suspended precipitate,
(v) a report of the determination of the proportion of the nitrogen in the crystalline component of the suspended precipitate,
(vi) a report of assay of the zinc content of the supernatant liquid after removal of the suspended precipitate,
(vii) a report on the determination of its pH, and
(viii) a report on the microscopic appearance of the suspended precipitate; and
(c) for the first filling of the first finished lot of Insulin Zinc Suspension — Prolonged from each master lot of insulin or zinc-insulin crystals,
(i) a report on the determination of its pH,
(ii) a report on the microscopic examination of the precipitate, and
(iii) a report on its identification as determined by an acceptable method.
(iv) [Repealed, SOR/95-203, s. 5]
C.04.574 The expiration date printed on the inner and outer labels of every package of Insulin Zinc Suspension — Prolonged shall be a date not later than two years after the date of filling of the immediate container.
Globin Insulin with Zinc
C.04.575 The insulin preparation “Globin Insulin with Zinc” shall be a sterile solution of insulin modified by the addition of globin prepared from beef blood, in the form of globin hydrochloride, and zinc, shall be a clear, yellowish, or almost colourless liquid free from insoluble matter and acceptably free from turbidity, shall have a pH of not less than 3.4 and not more than 3.8 and shall contain,
(a) weight by volume, not less than 1.3 per cent and not more than 1.7 per cent glycerin, and either
(i) not less than 0.15 per cent and not more than 0.20 per cent cresol, or
(ii) not less than 0.20 per cent and not more than 0.26 per cent phenol, and
(b) as determined by an acceptable method, for each 1,000 International Units of insulin,
(i) not more than 15.0 milligrams of total nitrogen,
(ii) not less than 36.0 milligrams and not more than 40.0 milligrams of globin calculated as 6.0 times the nitrogen content of the globin, and
(iii) not less than 2.5 milligrams and not more than 3.5 milligrams of zinc.
C.04.576 The globin hydrochloride used in the preparation of Globin Insulin with Zinc shall contain not less than 16.0 per cent and not more than 17.5 per cent nitrogen calculated on a dry, ash-free and hydrochloric acid-free basis, and its ash content shall be not more than 0.3 per cent as determined by an acceptable method.
C.04.577 The insulin used in the preparation of Globin Insulin with Zinc shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40 or 80 International Units of insulin in each cubic centimetre of the Globin Insulin with Zinc.
C.04.578 (1) The Canadian Reference Standard for Globin Insulin with Zinc shall be the standard adopted therefor by the Director from time to time.
(2) Upon application of a person who holds an establishment licence, the Director shall furnish him with a portion of the Canadian Reference Standard with directions for comparative testing.
(3) The testing of the biological reaction of Globin Insulin with Zinc shall be made by an acceptable method and that biological reaction shall be comparable to the biological reaction of the portion of the Canadian Reference Standard furnished by the Director.
C.04.579 No person shall sell Globin Insulin with Zinc unless
(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and
(b) each cubic centimetre thereof provides,
(i) 40 International Units of insulin, or
(ii) 80 International Units of insulin.
C.04.580 (1) A fabricator shall not sell Globin Insulin with Zinc unless he
(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;
(b) has furnished the Director with such additional information as the Director may require; and
(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.
(2) A submission filed pursuant to subsection (1) shall include at least,
(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Globin Insulin with Zinc,
(i) protocols of assay of its potency expressed in International Units per cubic centimetre in the case of insulin, and in International Units per milligram in the case of zinc-insulin crystals,
(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and
(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;
(b) for the master lot of globin hydrochloride used in the preparation of Globin Insulin with Zinc, reports of assay of
(i) its nitrogen content in per cent calculated on a dry, ash-free and hydrochloric acid free basis,
(ii) its chloride content in per cent calculated as hydrochloride, and
(iii) its ash content in percentage;
(c) for the components used in the preparation of the trial mixture of Globin Insulin with Zinc, a report on the quantity of
(i) insulin in grams, or in International Units,
(ii) zinc in grams, or in milligrams, per 1,000 International Units of insulin,
(iii) globin hydrochloride in grams or in milligrams, per 1,000 International Units of insulin, and
(iv) the volume of the preparation in cubic centimetres or litres;
(d) for the trial mixture of Globin Insulin with Zinc,
(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(iii) protocols of the biological reaction showing the retardation of the insulin effect, and
(iv) a report on the determination of its pH;
(e) for the first finished lot of Globin Insulin with Zinc from each trial mixture of Globin Insulin with Zinc, a report on the amount of each component in the preparation; and
(f) for the first filling of the first finished lot of Globin Insulin with Zinc from each trial mixture of Globin Insulin with Zinc,
(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin, and
(iii) a report on the determination of its pH.
(iv) [Repealed, SOR/95-203, s. 6]
C.04.581 The expiration date printed on the inner and outer labels of every package of Globin Insulin with Zinc shall be a date not later than two years after the date of filling of the immediate container.
NPH Insulin or Isophane Insulin
C.04.582 The insulin preparation “NPH Insulin” or “Isophane Insulin” shall be a sterile preparation of rod-shaped crystals containing insulin, protamine and zinc, suspended in a buffered aqueous medium, shall have a pH of not less than 7.0 and not more than 7.8 and shall contain
(a) weight by volume, not less than 0.15 per cent and not more than 0.25 per cent anhydrous disodium phosphate, and either
(i) not less than 1.4 per cent and not more than 1.8 per cent glycerin and not less than 0.15 per cent and not more than 0.17 per cent metacresol and not less than 0.06 and not more than 0.07 per cent phenol, or
(ii) not less than 0.40 per cent and not more than 0.45 per cent sodium chloride and not less than 0.7 per cent and not more than 0.9 per cent glycerin and not less than 0.18 per cent and not more than 0.22 per cent metacresol; and
(b) as determined by an acceptable method, for each 1,000 International Units of insulin,
(i) not more than 8.5 milligrams of nitrogen,
(ii) not less than 3.0 milligrams and not more than 6.0 milligrams of protamine except that the ratio of the protamine to the insulin shall be not less than the isophane ratio and shall not exceed the isophane ratio by more than 10 per cent,
(iii) not less than 0.16 milligram and not more than 0.40 milligram of zinc, and
(iv) no protease activity significant for the stability of NPH insulin.
C.04.583 The protamine used in preparing NPH Insulin shall be obtained from the sperm or from the mature testes of fish belonging to the family Salmonidae, genera Oncorhynchus Suckley, or Salmo Linne.
C.04.584 The isophane ratio means the minimum number of milligrams of protamine required to precipitate 100 International Units of insulin and shall be determined by an acceptable method.
C.04.585 The insulin used in the preparation of NPH Insulin shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly.
C.04.586 The clear supernatant liquid obtained from NPH insulin shall contain not more than 0.4 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 40 units per cubic centimetre, not more than 0.6 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 80 units per cubic centimetre and not more than 0.7 International Units of insulin per cubic centimetre when the potency of the insulin preparation is 100 units per cubic centimetre, as determined by an acceptable method.
C.04.587 No person shall sell NPH Insulin unless
(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and
(b) each cubic centimetre thereof provides,
(i) 40 International Units of insulin,
(ii) 80 International Units of insulin, or
(iii) 100 International Units of insulin.
C.04.588 (1) A fabricator shall not sell NPH Insulin unless he
(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;
(b) has furnished the Director with such additional information as the Director may require; and
(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.
(2) A submission filed pursuant to subsection (1) shall include at least,
(a) for each master lot of zinc-insulin crystals employed in the manufacture of NPH Insulin,
(i) protocols of assay of its potency in International Units per milligram,
(ii) a report of its moisture content in per cent determined by drying to constant weight at 100°C, and
(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin;
(b) for the master lot of protamine, a report of the isophane ratio for the insulin used in the preparation of the NPH Insulin;
(c) for the trial mixture of NPH Insulin,
(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(iii) a report of the insulin content in International Units per cubic centimetre of the supernatant liquid after removal of the suspended precipitate,
(iv) a report on the determination of its pH, and
(v) a report on the microscopic examination of the precipitate;
(d) for the first finished lot of NPH Insulin from each trial mixture of NPH Insulin, a report on the amount of each component in the preparation; and
(e) for the first filling of the first finished lot of NPH Insulin from each trial mixture of NPH Insulin,
(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(iii) a report on the determination of its pH,
(iv) a report on the microscopic examination of the precipitate, and
(v) a report of its identification as determined by an acceptable method.
(vi) [Repealed, SOR/95-203, s. 7]
C.04.589 The expiration date printed on the inner and outer labels of NPH Insulin shall be a date not later than two years after the date of filling of the immediate container.
Protamine Zinc Insulin
C.04.590 The insulin preparation “Protamine Zinc Insulin” shall be a sterile white suspension in a buffered aqueous medium, containing insulin modified by the addition of protamine and zinc, shall have a pH of not less than 7.1 and not more than 7.4, and shall contain,
(a) weight by volume,
(i) not less than 0.15 per cent and not more than 0.25 per cent anhydrous disodium phosphate,
(ii) not less than 1.4 per cent and not more than 1.8 per cent glycerin, and
(iii) either not less than 0.18 per cent and not more than 0.22 per cent cresol, or not less than 0.22 per cent and not more than 0.28 per cent phenol; and
(b) as determined by an acceptable method, for each 1,000 International Units of insulin,
(i) not more than 12.5 milligrams of total nitrogen,
(ii) not less than 10.0 milligrams and not more than 15.0 milligrams of protamine,
(iii) not less than 1.7 milligrams and not more than 2.5 milligrams of zinc.
C.04.591 The protamine used in the preparation of Protamine Zinc Insulin shall be obtained from the sperm or from the mature testes of fish belonging to the family Salmonidae, genera Oncorhunchus Suckley or Salmo Linne.
C.04.592 The insulin used in the preparation of Protamine Zinc Insulin shall be obtained from one or more master lots and shall be present in an amount sufficient to provide either 40, 80 or 100 International Units of insulin in each cubic centimetre of the preparation when the precipitate is suspended uniformly.
C.04.593 (1) The Canadian Reference Standard for Protamine Zinc Insulin shall be the standard adopted therefor by the Director from time to time.
(2) Upon application of a person who holds an establishment licence, the Director shall furnish him with a portion of the Canadian Reference Standard with directions for comparative testing.
(3) The testing of the biological reaction of Protamine Zinc Insulin shall be made by an acceptable method and that biological reaction shall be comparable to the biological reaction of the portion of the Canadian Reference Standard furnished by the Director.
C.04.594 No person shall sell Protamine Zinc Insulin unless
(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres; and
(b) each cubic centimetre thereof provides
(i) 40 International Units of insulin,
(ii) 80 International Units of insulin, or
(iii) 100 International Units of insulin.
C.04.595 (1) A fabricator shall not sell Protamine Zinc Insulin unless he
(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;
(b) has furnished the Director with such additional information as the Director may require; and
(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.
(2) A submission filed pursuant to subsection (1) shall include at least,
(a) for each master lot of insulin or zinc-insulin crystals employed in the manufacture of Protamine Zinc Insulin,
(i) protocols of assay of its potency in International Units per cubic centimetre in the case of insulin and in International Units per milligram in the case of zinc-insulin crystals,
(ii) a report on its moisture content in percentage determined by drying to constant weight at 100°C in the case of zinc-insulin crystals, and
(iii) reports of assay of its nitrogen content in milligrams, and its zinc content in milligrams per 1,000 International Units of insulin;
(b) for the components used in the preparation of the trial mixture of Protamine Zinc Insulin, a report on the quantity of
(i) insulin in grams or in International Units,
(ii) zinc in grams or in milligrams, per 1,000 International Units of insulin,
(iii) protamine in grams or in milligrams, per 1,000 International Units of insulin, and
(iv) the volume of the preparation in cubic centimetres or litres;
(c) for the trial mixture of Protamine Zinc Insulin,
(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units of insulin,
(ii) a report of assay of its zinc content in milligrams per cubic centimetre per 1,000 International Units of insulin,
(iii) protocols of its biological reaction showing retardation of the insulin effect, and
(iv) a report on the determination of its pH;
(d) for the first finished lot of Protamine Zinc Insulin from each trial mixture of Protamine Zinc Insulin, a report on the amount of each component in the preparation; and
(e) for the first filling of the first finished lot of Protamine Zinc Insulin from each trial mixture of Protamine Zinc Insulin,
(i) a report of assay of its nitrogen content in milligrams per cubic centimetre or per 1,000 International Units,
(ii) a report of assay of its zinc content in milligrams per cubic centimetre or per 1,000 International Units, and
(iii) a report on the determination of its pH.
(iv) [Repealed, SOR/95-203, s. 8]
C.04.596 The expiration date printed on the inner and outer labels of every package of Protamine Zinc Insulin shall be a date not later than two years after the date of filling of the immediate container.
Sulphated Insulin
C.04.597 The insulin preparation “Sulphated Insulin” shall be a clear or slightly turbid, colourless or almost colourless, sterile, isotonic preparation of zinc-insulin crystals chemically modified by treatment with sulphuric acid, shall have a pH of not less than 6.0 and not more than 7.0, and shall contain,
(a) weight by volume,
(i) not less than 0.6 per cent and not more than 1.0 per cent sodium chloride, and
(ii) not less than 0.2 per cent and not more than 0.3 per cent phenol; and
(b) as determined by an acceptable method,
(i) not more than 200 milligrams protein for each 1,000 International Units of insulin, and
(ii) not less than 5.5 and not more than 6.5 sulphate groups per insulin molecule.
C.04.598 The neutralization ratio means the amount of anti-beef-insulin serum required to neutralize one unit of Sulphated Insulin divided by the amount required to neutralize one unit of beef insulin, and shall be determined by an acceptable method.
C.04.599 The neutralization ratio of Sulphated Insulin shall be not less than 4 to 1.
C.04.600 No person shall sell Sulphated Insulin unless
(a) it is dispensed in a vial of approximately 10 cubic centimetre capacity that contains an excess volume sufficient to permit withdrawal of 10 cubic centimetres, and
(b) each cubic centimetre thereof provides 100 International Units of insulin as determined by an acceptable method.
C.04.601 (1) A fabricator shall not sell Sulphated Insulin unless he
(a) has filed with the Director, in accordance with subsection (2), a submission relating to that preparation, in a form and having a content satisfactory to the Director;
(b) has furnished the Director with such additional information as the Director may require; and
(c) has received from the Director a notice that the information contained in the submission is in accordance with the requirements of this section.
(2) A submission filed pursuant to subsection (1) shall include at least,
(a) for each master lot of zinc-insulin crystals employed in the manufacture of Sulphated Insulin,
(i) protocols of assay of its potency in International Units per milligram,
(ii) a report of its moisture content in percentage determined by drying to constant weight at 100°C, and
(iii) reports of assay of its nitrogen content in milligrams and its zinc content in milligrams per 1,000 International Units of insulin; and
(b) for each lot of Sulphated Insulin prepared from each master lot of zinc-insulin crystals,
(i) a report of the amount of each component,
(ii) a report of the protein content in milligrams per 1,000 International Units of insulin,
(iii) a report on the determination of the neutralization ratio,
(iv) a report on the determination of the number of sulphate groups per insulin molecule,
(v) protocols of assay of its potency expressed as International Units per cubic centimetre, and
(vi) a report on the determination of its pH.
(vii) [Repealed, SOR/95-203, s. 9]
C.04.602 The expiration date printed on the inner and outer labels of every package of Sulphated Insulin shall be a date not later than two years after the date of filling of the immediate container.
Labelling of Insulin Preparations
C.04.650 The packager/labeller of Insulin Injection may label that insulin preparation “Insulin made from Zinc-Insulin crystals” only when it has been prepared from zinc-insulin crystals.
C.04.651 The packager/labeller of an insulin preparation shall print the information required by these Regulations to appear on both the inner and outer labels of every package of that insulin preparation as set out in the Table to this section.
TABLE
ItemColumn IColumn IIColumn IIIInsulin PreparationPotency of PreparationSpecial Printing Requirements for Label1Insulin Injection, not labelled as set out in item 2.(a) 40 units per cc.(a) black ink on yellow stock.(b) 80 units per cc.(b) black ink on green stock.(c) 100 units per cc.(c) black ink on white stock.2Insulin Injection, labelled “Insulin made from Zinc-Insulin crystals.”(a) 40 units per cc.(a) red ink on grey stock.(b) 80 units per cc.(b) green ink on grey stock.(c) 100 units per cc.(c) black ink on white stock.3Insulin Zinc Suspension — Rapid, Insulin Zinc Suspension — Medium and Insulin Zinc Suspension — Prolonged.(a) 40 units per cc.(a) red ink on lavender stock plus a distinguishing mark or design.(b) 80 units per cc.(b) green ink on lavender stock plus a distinguishing mark or design.(c) 100 units per cc.(c) black ink on white stock.4Globin Insulin with Zinc.(a) 40 units per cc.(a) red ink on brown stock except that the expression “40 units per cubic centimetre” may be printed in white letters on a red background.(b) 80 units per cc.(b) green ink on brown stock except that the expression “80 units per cubic centimetre” may be printed in white letters on a green background.5NPH Insulin.(a) 40 units per cc.(a) red ink on blue stocks.(b) 80 units per cc.(b) green ink on blue stock.(c) 100 units per cc.(c) black ink on white stock.6Protamine Zinc Insulin.(a) 40 units per cc.(a) red ink on white stock.(b) 80 units per cc.(b) green ink on white stock.(c) 100 units per cc.(c) black ink on white stock7Sulphated Insulin.100 units per cc.black ink on white stock plus the statement “Warning... Not for Ordinary Use... See Package Leaflet”.C.04.652 The packager/labeller of an insulin preparation shall print on the outer label of every package thereof instructions to store the preparation in a refrigerator at 35° to 50°F (2° to 10°C) and to avoid exposing it to freezing.
C.04.653 The packager/labeller of an insulin preparation that consists of a precipitate suspended in a buffered aqueous medium shall print on the inner label of every package thereof the statement “Shake Carefully”.
C.04.654 The packager/labeller of an insulin preparation may, in lieu of printing adequate directions for its use on both the inner and outer labels thereof as required by subparagraph C.04.019(a)(vii), print the descriptions for use in a descriptive circular prepared in accordance with section C.04.655, but in such case he shall
(a) enclose a copy of the circular in the package containing the preparation; and
(b) state on the outer label of the package that such a circular is enclosed therein.
C.04.655 The descriptive circular referred to in section C.04.654 shall include, at least, the following information:
(a) a statement that
(i) the treatment of diabetes mellitus requires medical supervision and review,
(ii) insulin preparations should be used only as determined by a physician for each patient in the light of blood-sugar and urinary-sugar findings, and
(iii) the physician’s instructions concerning diet, dosage, rest and exercise should be followed carefully;
(b) an outline of the procedure to be followed in withdrawing the insulin preparation from the vial, including techniques for sterilization of the syringe and needle, vial-stopper and site of injection;
(c) a statement explaining that injections should be subcutaneous, and not intravenous or intramuscular, and a caution against successive injections in any one site;
(d) a statement that doses are specified in terms of Units of potency per cubic centimetre and that the volume of each dose will depend upon the potency in terms of units per cubic centimetre stated on the label of the insulin preparation and that, for these reasons, it is important that the patient understand the markings on syringes;
(e) a brief explanation of hypoglycemia together with emergency measures suitable for use by patients and those caring for patients in the event of hypoglycemic reactions;
(f) a statement indicating the possibility of undesirable reactions associated with illness or infection, with the omission or loss of a meal, and with a shortage of the insulin preparation;
(g) a statement warning against using any other type of insulin preparation than that prescribed by the physician;
(h) a statement that the use of a package should not be commenced after the expiration date printed on the package;
(i) a statement that the contents should be used as continuously as practicable and that any vial from which a part of the contents has been withdrawn should be discarded in the event of its being in disuse for several weeks’ time;
(j) a statement stressing the importance of visiting a physician regularly and of carefully following his instructions;
(k) in the case of insulin preparations consisting of a clear, colourless or almost colourless solution, free from turbidity and from insoluble matter, a statement that if the contents of the vial become cloudy or turbid, use of that vial should be discontinued;
(l) in the case of insulin preparations consisting of a precipitate suspended in a buffered aqueous medium, a statement explaining that it is necessary to shake the vial carefully before withdrawing a dose, noting that if the contents have become lumpy or granular in appearance or have formed a deposit of particles on the wall of the container, the use of that vial should be discontinued;
(m) instructions that the insulin preparation should be stored in a refrigerator at 35° to 50°F (2° to 10°C) and should not be exposed to freezing; and
(n) in the case of Sulphated Insulin, a statement explaining that this insulin preparation is not for ordinary use, but is a chemically modified insulin which may be more effective than the usual insulin preparations in certain insulin-resistant or insulin-allergic diabetic patients.
C.04.656 (1) Notwithstanding section C.04.554, a person who holds an establishment licence may sell Insulin Injection made from zinc-insulin crystals contained in vials of approximately 20 cubic centimetre capacity each of which vials
(a) contains an excess volume sufficient to permit withdrawal of 20 cubic centimetres, and
(b) provides 500 International Units of insulin per cubic centimetre,
if
(c) notwithstanding section C.04.651, both the inner and outer labels are printed in black ink on white stock and overprinted in narrow brown and white diagonal stripes, of which there shall be at least five but not more than 20 to each inch;
(d) both the inner and the outer labels carry the statement “Warning — High Potency — Not for Ordinary Use”; and
(e) each package contains a descriptive circular that conforms to the requirements of section C.04.655 and, in addition, includes,
(i) at the beginning of the circular the statement:
“Warning — This insulin preparation contains 500 International Units of insulin in each cubic centimetre. Extreme caution must be observed in the measurement of doses because inadvertent overdose may result in irreversible shock. Serious consequences may result if it is used other than under constant medical supervision. Unless specifically prescribed it should never be used by patients to replace use of any other insulin preparations.”,
(ii) a statement that Insulin made from Zinc-Insulin crystals 500 International Units per cubic centimetre should not be administered intravenously, and
(iii) a statement giving information for the safe and effective use by physicians of the drug in insulin shock therapy and in the treatment of diabetic patients with high insulin resistance (daily requirement more than 200 International Units of insulin).
(2) [Repealed, SOR/95-203, s. 10]
Anterior Pituitary Extracts
C.04.675 Anterior pituitary extract shall include all natural products, prepared from the anterior lobe of the pituitary gland of animals, having physiological properties associated with the hormones of the anterior pituitary gland and their proper names shall be
(a) Adrenocorticotrophic Hormone, Corticotrophin,
(b) Thyrotrophic Hormone, Thyrotrophin,
(c) Growth Hormone Pituitary, Somatotrophin,
(d) Lactogenic Hormone, Prolactin,
(e) Gonadotrophic Hormone, Gonadotrophin, followed by qualifying words to indicate the gonadotrophic activity associated with the extract,
and if unpurified anterior pituitary extract
(f) Pituitary Extract Anterior Lobe followed by qualifying words to indicate the physiological properties associated with it.
C.04.676 Reference standards for anterior pituitary extract shall be
(a) the International Standard,
(b) where no International Standard exists, the Canadian Reference Standard shall be that established and kept by the Director from whom portions for comparative testing may be had upon application, and
(c) where neither an International Standard nor a Canadian Reference Standard exists, a provisional reference standard that shall be a suitable quantity of the product submitted by the distributor referred to in paragraph C.01A.003(b) to the Director for checking the uniformity of the product.
C.04.677 Both the inner and outer labels of an anterior pituitary extract shall carry a statement of the potency in terms of the reference standard for anterior pituitary extract provided in section C.04.676 as determined by an acceptable method, except that where no reference standard for an anterior pituitary extract exists, the distributor referred to in paragraph C.01A.003(b) shall include, with every package of the anterior pituitary extract, an acceptable statement of the unit of potency and the method of assay used.
C.04.678 No person who holds an establishment licence shall sell corticotrophic hormones for subcutaneous or intramuscular use unless the preparation has been assayed by an acceptable method involving subcutaneous injection and, where the preparation is recommended for intravenous use, the label carries specific dosage instructions for that use.
C.04.679 No person shall sell as such adrenocorticotrophic hormone, thyrotrophic hormone, growth hormone pituitary, lactogenic hormone, or gonadotrophic hormone that is not acceptable free from any anterior pituitary extract other than the one for which it is named.
C.04.680 The outer label of a mixture of two or more of adrenocorticotrophic hormone, thyrotrophic hormone, growth hormone pituitary, lactogenic hormone and gonadotrophic hormone, or a mixture of any of those with pituitary extract anterior lobe, shall carry a declaration of the proper name and the amount of each component of the mixture.
C.04.681 The outer label of an anterior pituitary extract or mixture of anterior pituitary extracts shall carry a statement
(a) showing the species of animal from which the glands used in the preparation of the anterior pituitary extract were obtained,
(b) that it shall be stored at refrigerator temperature, and
(c) that, except in the case of gonadotrophic hormones, it is to be used only on the advice or on the prescription of a physician.
C.04.682 Both the inner and outer labels of adrenocorticotrophic hormone shall carry a statement indicating the route of administration, in addition to meeting the requirements of paragraphs C.04.681(a) and (b).
C.04.683 The expiration date for an anterior pituitary extract or mixture of anterior pituitary extracts shall be not more than two years after the date of passing a potency test.
DIVISION 5
Drugs For Clinical Trials Involving Human Subjects
Interpretation
C.05.001 The definitions in this section apply in this Division.
adverse drug reaction
adverse drug reaction means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. (réaction indésirable à une drogue)
adverse event
adverse event means any adverse occurrence in the health of a clinical trial subject who is administered a drug, that may or may not be caused by the administration of the drug, and includes an adverse drug reaction. (incident thérapeutique)
clinical trial
clinical trial means an investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug. (essai clinique)
drug
drug means a drug for human use that is to be tested in a clinical trial. (drogue)
good clinical practices
good clinical practices means generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section C.05.010. (bonnes pratiques cliniques)
import
import means to import a drug into Canada for the purpose of sale in a clinical trial. (importer)
investigator’s brochure
investigator’s brochure means, in respect of a drug, a document containing the preclinical and clinical data on the drug that are described in paragraph C.05.005(e). (brochure du chercheur)
protocol
protocol means a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. (protocole)
qualified investigator
qualified investigator means the person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is
(a) in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; and
(b) in any other case, a physician and a member in good standing of a professional medical association. (chercheur qualifié)
research ethics board
research ethics board means a body that is not affiliated with the sponsor, and
(a) the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being; and
(b) that has at least five members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act, that is composed of both men and women and that includes at least
(i) two members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline or, if the clinical trial is in respect of a drug to be used for dental purposes only, is from a medical or dental discipline,
(ii) one member knowledgeable in ethics,
(iii) one member knowledgeable in Canadian laws relevant to the biomedical research to be approved,
(iv) one member whose primary experience and expertise are in a non-scientific discipline, and
(v) one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or the site where the clinical trial is to be conducted. (comité d’éthique de la recherche)
serious adverse drug reaction
serious adverse drug reaction means an adverse drug reaction that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave à une drogue)
serious unexpected adverse drug reaction
serious unexpected adverse drug reaction means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out in the investigator’s brochure or on the label of the drug. (réaction indésirable grave et imprévue à une drogue)
sponsor
sponsor means an individual, corporate body, institution or organization that conducts a clinical trial. (promoteur)
Application
C.05.002 (1) Subject to subsection (2), this Division applies to the sale or importation of drugs to be used for the purposes of clinical trials involving human subjects.
(2) Except for paragraph C.05.003(a), subsections C.05.006(2) and (3), paragraphs C.05.010(a) to (i), section C.05.011, subsections C.05.012(1) and (2), paragraphs C.05.012(3)(a) to (d) and (f) to (h), subsection C.05.012(4) and sections C.05.013, C.05.016 and C.05.017, this Division does not apply to the sale or importation of a drug for the purposes of a clinical trial authorized under subsection C.05.006(2).
Prohibition
C.05.003 Despite sections C.01.014, C.08.002 and C.08.003, no person shall sell or import a drug for the purposes of a clinical trial unless
(a) the person is authorized under this Division;
(b) the person complies with this Division and sections C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136, and C.01.435; and
(c) if the drug is to be imported, the person has a representative in Canada who is responsible for the sale of the drug.
General
C.05.004 Despite these Regulations, a sponsor may submit an application under this Division to sell or import a drug for the purposes of a clinical trial that contains a substance the sale of which is prohibited by these Regulations, if the sponsor establishes, on the basis of scientific information, that the inclusion of the substance in the drug may result in a therapeutic benefit for a human being.
Application for Authorization
C.05.005 An application by a sponsor for authorization to sell or import a drug for the purposes of a clinical trial under this Division shall be submitted to the Minister, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer and shall contain the following information and documents:
(a) a copy of the protocol for the clinical trial;
(b) a copy of the statement, as it will be set out in each informed consent form, that states the risks and anticipated benefits arising to the health of clinical trial subjects as a result of their participation in the clinical trial;
(c) a clinical trial attestation, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer, containing
(i) the title of the protocol and the clinical trial number,
(ii) the brand name, the chemical name or the code for the drug,
(iii) the therapeutic and pharmacological classifications of the drug,
(iv) the medicinal ingredients of the drug,
(v) the non-medicinal ingredients of the drug,
(vi) the dosage form of the drug,
(vii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor,
(viii) if the drug is to be imported, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the sponsor’s representative in Canada who is responsible for the sale of the drug,
(ix) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the qualified investigator, if known at the time of submitting the application,
(x) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved the protocol referred to in paragraph (a) and approved an informed consent form containing the statement referred to in paragraph (b), if known at the time of submitting the application, and
(xi) a statement
(A) that the clinical trial will be conducted in accordance with good clinical practices and these Regulations, and
(B) that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading;
(d) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, if known at the time of submitting the application;
(e) an investigator’s brochure that contains the following information, namely,
(i) the physical, chemical and pharmaceutical properties of the drug,
(ii) the pharmacological aspects of the drug, including its metabolites in all animal species tested,
(iii) the pharmacokinetics of the drug and the drug metabolism, including the biological transformation of the drug in all animal species tested,
(iv) any toxicological effects in any animal species tested under a single dose study, a repeated dose study or a special study in respect of the drug,
(v) any results of carcinogenicity studies in any animal species tested in respect of the drug,
(vi) any results of clinical pharmacokinetic studies of the drug,
(vii) any information regarding drug safety, pharmacodynamics, efficacy and dose responses of the drug that were obtained from previous clinical trials in humans, and
(viii) if the drug is a radiopharmaceutical as defined in section C.03.201, information regarding directions for preparing the radiopharmaceutical, the radiation dosimetry in respect of the prepared radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;
(f) if the drug contains a human-sourced excipient, including any used in the placebo,
(i) information that indicates the human-sourced excipient has been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, issued a notice of compliance under subsection C.08.004(1), as the case may be, or
(ii) in any other case, sufficient information to support the identity, purity, potency, stability and safety of the human-sourced excipient;
(g) if the drug has not been assigned a drug identification number under subsection C.01.014.2(1) or, in the case of a new drug, a notice of compliance has not been issued under subsection C.08.004(1), the chemistry and manufacturing information in respect of the drug, including its site of manufacture; and
(h) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application.
Authorization
C.05.006 (1) Subject to subsection (3), a sponsor may sell or import a drug, other than a drug described in subsection (2), for the purposes of a clinical trial if
(a) the sponsor has submitted to the Minister an application in accordance with section C.05.005;
(b) the Minister does not, within 30 days after the date of receipt of the application, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug for any of the following reasons:
(i) that the information and documents in respect of the application
(A) were not provided in accordance with these Regulations, or
(B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or
(ii) that based on an assessment of the application, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that
(A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person,
(B) the clinical trial is contrary to the best interests of a clinical trial subject, or
(C) the objectives of the clinical trial will not be achieved;
(c) for each clinical trial site, the sponsor has obtained the approval of the research ethics board in respect of the protocol referred to in paragraph C.05.005(a) and in respect of an informed consent form that contains the statement referred to in paragraph C.05.005(b); and
(d) before the sale or importation of the drug at a clinical trial site, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h), if it was not submitted in respect of that clinical trial site at the time of submitting the application.
(2) Subject to subsection (3), a sponsor may sell or import a drug for the purposes of a clinical trial in respect of
(a) a new drug that has been issued a notice of compliance under subsection C.08.004(1), if the clinical trial is in respect of a purpose or condition of use for which the notice of compliance was issued; or
(b) a drug, other than a new drug, that has been assigned a drug identification number under subsection C.01.014.2(1), if the clinical trial is in respect of a use or purpose for which the drug identification number was assigned.
(3) A sponsor may not sell or import a drug for the purposes of a clinical trial
(a) during the period of any suspension made under section C.05.016 or C.05.017; or
(b) after a cancellation made under section C.05.016 or C.05.017.
Notification
C.05.007 If the sale or importation of a drug is authorized under this Division, the sponsor may make one or more of the following changes if the sponsor notifies the Minister in writing within 15 days after the date of the change:
(a) a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C.05.008; and
(b) a change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C.05.008.
Amendment
C.05.008 (1) Subject to subsections (4) and (5), when the sale or importation of a drug is authorized under this Division and the sponsor proposes to make an amendment referred to in subsection (2), the sponsor may sell or import the drug for the purposes of the clinical trial in accordance with the amended authorization, if the following conditions are met:
(a) the sponsor has submitted to the Minister an application for amendment in accordance with subsection (3);
(b) the Minister does not, within 30 days after the date of receipt of the application for amendment, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug in accordance with the amendment for any of the following reasons, namely,
(i) that the information and documents in respect of the application for amendment
(A) were not provided in accordance with these Regulations, or
(B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or
(ii) that based on an assessment of the application for amendment, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that
(A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person,
(B) the clinical trial is contrary to the best interests of a clinical trial subject, or
(C) the objectives of the clinical trial will not be achieved;
(c) before the sale or importation of the drug, the sponsor submits to the Minister
(i) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved any amended protocol submitted under paragraph (3)(a) or approved any amended statement submitted under paragraph (3)(c), and
(ii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve any amendment to the protocol, its reasons for doing so and the date on which the refusal was given;
(d) before the sale or importation of the drug, the sponsor maintains records concerning
(i) the information referred to in paragraph C.05.005(h), and
(ii) the information referred to in subparagraph C.05.005(c)(ix), if any of that information has changed since it was submitted;
(e) before the sale or importation of the drug in accordance with the amended authorization, the sponsor ceases to sell or import the drug in accordance with the existing authorization; and
(f) the sponsor conducts the clinical trial in accordance with the amended authorization.
(2) For the purposes of subsection (1), amendments are
(a) amendments to the protocol that affect the selection, monitoring or dismissal of a clinical trial subject;
(b) amendments to the protocol that affect the evaluation of the clinical efficacy of the drug;
(c) amendments to the protocol that alter the risk to the health of a clinical trial subject;
(d) amendments to the protocol that affect the safety evaluation of the drug;
(e) amendments to the protocol that extend the duration of the clinical trial; and
(f) amendments to the chemistry and manufacturing information that may affect the safety or quality of the drug.
(3) The application for amendment referred to in subsection (1) shall contain a reference to the application submitted under section C.05.005 and shall contain the following documents and information:
(a) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (e), a copy of the amended protocol that indicates the amendment, a copy of the protocol submitted under paragraph C.05.005(a), and the rationale for the amendment;
(b) if the application is in respect of an amendment referred to in paragraph (2)(e), a copy of the amended investigator’s brochure or an addendum to the investigator’s brochure that indicates the new information, including supporting toxicological studies and clinical trial safety data;
(c) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (f) and, as a result of that amendment, it is necessary to amend the statement referred to in paragraph C.05.005(b), a copy of the amended statement that indicates the new information; and
(d) if the application is in respect of an amendment referred to in paragraph (2)(f), a copy of the amended chemistry and manufacturing information that indicates the amendment, and the rationale for that amendment.
(4) If the sponsor is required to immediately make one or more of the amendments referred to in subsection (2) because the clinical trial or the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, the sponsor may immediately make the amendment and shall provide the Minister with the information referred to in subsection (3) within 15 days after the date of the amendment.
(5) A sponsor may not sell or import a drug for the purposes of a clinical trial
(a) during the period of any suspension made under section C.05.016 or C.05.017; or
(b) after a cancellation made under section C.05.016 or C.05.017.
Additional Information and Samples
C.05.009 If the information and documents submitted in respect of an application under section C.05.005 or an application for amendment under section C.05.008 are insufficient to enable the Minister to determine whether any of the reasons referred to in paragraph C.05.006(1)(b) or C.05.008(1)(b) exist, the Minister may require the sponsor to submit, within two days after receipt of the request, samples of the drug or additional information relevant to the drug or the clinical trial that are necessary to make the determination.
Sponsor’s Obligations
Good Clinical Practices
C.05.010 Every sponsor shall ensure that a clinical trial is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, shall ensure that
(a) the clinical trial is scientifically sound and clearly described in a protocol;
(b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and this Division;
(c) systems and procedures that assure the quality of every aspect of the clinical trial are implemented;
(d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins at the site;
(e) at each clinical trial site, there is no more than one qualified investigator;
(f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the qualified investigator;
(g) each individual involved in the conduct of the clinical trial is qualified by education, training and experience to perform his or her respective tasks;
(h) written informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before that person participates in the clinical trial but only after that person has been informed of
(i) the risks and anticipated benefits to his or her health arising from participation in the clinical trial, and
(ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial;
(i) the requirements respecting information and records set out in section C.05.012 are met; and
(j) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 to 4 except sections C.02.019, C.02.025 and C.02.026.
Labelling
C.05.011 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the drug bears a label that sets out the following information in both official languages:
(a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator;
(b) the name, number or identifying mark of the drug;
(c) the expiration date of the drug;
(d) the recommended storage conditions for the drug;
(e) the lot number of the drug;
(f) the name and address of the sponsor;
(g) the protocol code or identification; and
(h) if the drug is a radiopharmaceutical as defined in section C.03.201, the information required by subparagraph C.03.202(1)(b)(vi).
Records
C.05.012 (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification.
(2) The sponsor shall maintain complete and accurate records to establish that the clinical trial is conducted in accordance with good clinical practices and these Regulations.
(3) The sponsor shall maintain complete and accurate records in respect of the use of a drug in a clinical trial, including
(a) a copy of all versions of the investigator’s brochure for the drug;
(b) records respecting each change made to the investigator’s brochure, including the rationale for each change and documentation that supports each change;
(c) records respecting all adverse events in respect of the drug that have occurred inside or outside Canada, including information that specifies the indication for use and the dosage form of the drug at the time of the adverse event;
(d) records respecting the enrolment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the clinical trial subjects or other persons;
(e) records respecting the shipment, receipt, disposition, return and destruction of the drug;
(f) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by the qualified investigator prior to the commencement of his or her responsibilities in respect of the clinical trial, that states that
(i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and
(ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, inform both the clinical trial subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of clinical trial subjects or other persons;
(g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site; and
(h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices.
(4) The sponsor shall maintain all records referred to in this Division for a period of 25 years.
Submission of Information and Samples
C.05.013 (1) The Minister shall require a sponsor to submit, within two days after receipt of the request, information concerning the drug or the clinical trial, or samples of the drug, if the Minister has reasonable grounds to believe that
(a) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person;
(b) the clinical trial is contrary to the best interests of a clinical trial subject;
(c) the objectives of the clinical trial will not be achieved;
(d) a qualified investigator is not respecting the undertaking referred to in paragraph C.05.012(3)(f); or
(e) information submitted in respect of the drug or the clinical trial is false or misleading.
(2) The Minister may require the sponsor to submit, within seven days after receipt of the request, any information or records kept under section C.05.012, or samples of the drug, in order to assess the safety of the drug or the health of clinical trial subjects or other persons.
Serious Unexpected Adverse Drug Reaction Reporting
C.05.014 (1) During the course of a clinical trial, the sponsor shall inform the Minister of any serious unexpected adverse drug reaction in respect of the drug that has occurred inside or outside Canada as follows:
(a) if it is neither fatal nor life threatening, within 15 days after becoming aware of the information; and
(b) if it is fatal or life threatening, within seven days after becoming aware of the information.
(2) The sponsor shall, within eight days after having informed the Minister under paragraph (1)(b), submit to the Minister a complete report in respect of that information that includes an assessment of the importance and implication of any findings made.
(3) Sections C.01.016 and C.01.017 do not apply to drugs used for the purposes of a clinical trial.
Discontinuance of a Clinical Trial
C.05.015 (1) If a clinical trial is discontinued by the sponsor in its entirety or at a clinical trial site, the sponsor shall
(a) inform the Minister no later than 15 days after the date of the discontinuance;
(b) provide the Minister with the reason for the discontinuance and its impact on the proposed or ongoing clinical trials in respect of the drug conducted in Canada by the sponsor;
(c) as soon as possible, inform all qualified investigators of the discontinuance and of the reasons for the discontinuance, and advise them in writing of any potential risks to the health of clinical trial subjects or other persons; and
(d) in respect of each discontinued clinical trial site, stop the sale or importation of the drug as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the drug that have been sold.
(2) If the sponsor has discontinued the clinical trial in its entirety or at a clinical trial site, the sponsor may resume selling or importing the drug for the purposes of a clinical trial in its entirety or at a clinical trial site if, in respect of each clinical trial site where the sale or importation is to be resumed, the sponsor submits to the Minister the information referred to in subparagraphs C.05.005(c)(ix) and (x) and paragraphs C.05.005(d) and (h).
Suspension and Cancellation
C.05.016 (1) Subject to subsection (2), the Minister shall suspend the authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, if the Minister has reasonable grounds to believe that
(a) the sponsor has contravened these Regulations or any provisions of the Act relating to the drug;
(b) any information submitted in respect of the drug or clinical trial is false or misleading;
(c) the sponsor has failed to comply with good clinical practices; or
(d) the sponsor has failed to provide
(i) information or samples of the drug as required under section C.05.009 or C.05.013, or
(ii) information or a report under section C.05.014.
(2) Subject to section C.05.017, the Minister shall not suspend an authorization referred to in subsection (1) unless
(a) the Minister has sent to the sponsor a written notice of the intention to suspend the authorization that indicates whether the authorization is to be suspended in its entirety or at a clinical trial site and the reason for the intended suspension;
(b) the sponsor has not, within 30 days after receipt of the notice referred to in paragraph (a), provided the Minister with information or documents that demonstrate that the authorization should not be suspended on the grounds that
(i) the situation giving rise to the intended suspension did not exist, or
(ii) the situation giving rise to the intended suspension has been corrected; and
(c) the Minister has provided the sponsor with the opportunity to be heard in paragraph (b).
(3) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.
(4) If the Minister has suspended an authorization, the Minister shall
(a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension has been corrected; or
(b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 30 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a).
C.05.017 (1) The Minister shall suspend an authorization to sell or import a drug for the purposes of a clinical trial, in its entirety or at a clinical trial site, before giving the sponsor an opportunity to be heard if the Minister has reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a clinical trial subject or other person.
(2) The Minister shall suspend the authorization by sending to the sponsor a written notice of suspension of the authorization that indicates the effective date of the suspension, whether the authorization is suspended in its entirety or at a clinical trial site and the reason for the suspension.
(3) If the Minister has suspended an authorization, the Minister shall
(a) reinstate the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor provides the Minister with information or documents that demonstrate that the situation giving rise to the suspension did not exist or that it has been corrected; or
(b) cancel the authorization in its entirety or at a clinical trial site, as the case may be, if within 60 days after the effective date of the suspension the sponsor has not provided the Minister with the information or documents referred to in paragraph (a).
DIVISION 6
Canadian Standard Drugs
Conjugated Estrogens
Conjugated Estrogens for Injection
Conjugated Estrogens Tablets
Digitoxin
Digitoxin Tablets
Digoxin
Digoxin Elixir
Digoxin Injection
Digoxin Tablets
Esterified Estrogens
Esterified Estrogens Tablets
Gelatin
Thyroid
General
C.06.001 In this Division,
(a) solubility and specific gravity shall be determined at 25°C;
(b) tests for identity, quantitative tests for arsenic, lead, copper, zinc, fluorine, and sulphur dioxide, and limit tests shall be made by the official methods; and
(c) determination of physical and chemical constants shall be carried out by acceptable methods.
Conjugated Estrogens
C.06.002 [S]. Conjugated estrogens shall be the drug conjugated estrogens described in The Pharmacopeia of the United States of America, XVIII (1970), except that
(a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and
(b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.
Conjugated Estrogens for Injection
C.06.003 [S]. Conjugated estrogens for injection shall be the drug conjugated estrogens for injection described in The Pharmacopeia of the United States of America, XVIII (1970), except that
(a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and
(b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.
Conjugated Estrogens Tablets
C.06.004 [S]. Conjugated estrogens tablets shall be the drug conjugated estrogens tablets described in The Pharmacopeia of the United States of America, XVIII (1970), except that
(a) the dilute assay preparation A, assay preparations A and B and equilin reagent described therein shall be prepared by official method DO-29, Conjugated Estrogens, October 15, 1981; and
(b) the identification test described therein shall be performed by official method DO-29, Conjugated Estrogens, October 15, 1981.
C.06.100 and C.06.101 [Repealed, SOR/80-544, s. 12]
Digitoxin
C.06.120 [S]. Digitoxin shall be the drug digitoxin described in the Pharmacopeia of the United States of America.
Digitoxin Tablets
C.06.121 [S]. Digitoxin tablets shall be the drug digitoxin tablets described in the Pharmacopeia of the United States of America.
Digoxin
C.06.130 [S]. Digoxin shall be the drug digoxin described in the Pharmacopeia of the United States of America.
Digoxin Elixir
C.06.131 [S]. Digoxin Elixir shall be the drug digoxin elixir described in the Pharmacopeia of the United States of America.
Digoxin Injection
C.06.132 [S]. Digoxin injection shall be the drug digoxin injection described in the Pharmacopeia of the United States of America.
Digoxin Tablets
C.06.133 [S]. Digoxin tablets shall be the drug digoxin tablets described in the Pharmacopeia of the United States of America.
C.06.140 to C.06.142 [Repealed, SOR/80-544, s. 12]
C.06.150 to C.06.153 [Repealed, SOR/80-544, s. 12]
C.06.154 to C.06.156 [Repealed, SOR/80-544, s. 12]
C.06.157 to C.06.160 [Repealed, SOR/80-544, s. 12]
Esterified Estrogens
C.06.161 [S]. Esterified estrogens shall be the drug esterified estrogens described in the Pharmacopeia of the United States of America.
Esterified Estrogens Tablets
C.06.162 [S]. Esterified estrogens tablets shall be the drug esterified estrogens tablets described in the Pharmacopeia of the United States of America.
Gelatin
C.06.170 Gelatin shall be the drug gelatin described in the Pharmacopeia of the United States or the British Pharmacopeia.
C.06.180 to C.06.183 [Repealed, SOR/80-544, s. 12]
C.06.230 to C.06.233 [Repealed, SOR/80-544, s. 12]
C.06.240 to C.06.242 [Repealed, SOR/80-544, s. 12]
Thyroid
C.06.250 Thyroid shall be the cleaned, dried, powdered thyroid glands of domestic animals used for food, and shall contain not less than 0.17 per cent, and not more than 0.23 per cent iodine and no added iodine in either inorganic or organic form, and
(a) its characters are
Description, —
(i) General, — thyroid occurs as a cream-coloured, amorphous powder; the odour and taste are faint and meat-like, and
(ii) Microscopical, — when suitably mounted and examined under the microscope, thyroid shows the following: numerous smooth to striated hyaline fragments of colloids, of angular to irregular shape, that are colourless to pale yellow in water mounts, brown in Mallory’s stain and pink in solution of eosin, some of these fragments containing granules, minute vacuoles, crystalloidal bodies and cells; numerous irregular fragments of follicular epithelium staining brown with Mallory’s stain, the individual cells more or less polygonal to rounded-angular or irregularly cuboidal, often with prominent nuclei staining dark blue, their cytoplasm purplish with Delafield’s solution of haematoxylin; slender glistening segments of capillaries of closely undulate outline; numerous slender segments of neuraxons; numerous aggregates of particles of intercellular substance and slender, mostly straight connective tissue fibres staining blue to greenish blue with a mixture of Mallory’s stain and solution of phosphotungstic acid, the bundles of fibres often appearing reddish in Mallory’s stain; few glistening fragments of blood vessels with serrated or crenated ends as viewed in water mounts; and
(b) the tests for its purity are
(i) Inorganic iodine, — add to one gram of thyroid 10 millilitres of a saturated solution of zinc sulphate in water, shake, allow to stand five minutes, and filter through a fritted glass filter; add to five millilitres of the filtrate 0.5 millilitre of mucilage of starch and four drops each of a 10 per cent w/v solution of sodium nitrite in water and dilute sulphuric acid, shaking after each addition: no blue colour is produced, and
(ii) Moisture, — thyroid loses not more than six per cent moisture.
C.06.251 Thyroid shall be
(a) assayed by official method DO-26, Thyroid, October 15, 1981; and
(b) stored in a cool place and in a tightly-closed container.
C.06.252 [Repealed, SOR/80-544, s. 12]
C.06.260 to C.06.264 [Repealed, SOR/80-544, s. 12]
C.06.270 to C.06.280 [Repealed, SOR/80-544, s. 12]
Division 7
SALE OF DRUGS FOR THE PURPOSES OF IMPLEMENTING THE GENERAL COUNCIL DECISION
Interpretation
C.07.001 The definitions in this section apply in this Division.
Commissioner of Patents
Commissioner of Patents means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. (commissaire aux brevets)
General Council Decision
General Council Decision has the meaning assigned by subsection 30(6) of the Act. (décision du Conseil général)
Application
C.07.002 This Division applies to the sale of drugs for the purposes of implementing the General Council Decision.
Application for Authorization
C.07.003 An application by a manufacturer for authorization to sell a drug under this Division shall be submitted to the Minister and shall contain the following information and documents:
(a) a statement that the manufacturer intends to file an application with the Commissioner of Patents under section 21.04 of the Patent Act;
(b) in respect of a new drug, the submission number and date of filing of the new drug submission or abbreviated new drug submission filed under section C.08.002 or C.08.002.1, respectively, and of any supplement filed under section C.08.003 in respect of the drug;
(c) in respect of a drug that is not a new drug,
(i) the application number and date of filing of the application that has been filed under section C.01.014.1 in respect of the drug, or
(ii) the drug identification number, if one has been assigned in respect of the drug pursuant to section C.01.014.2;
(d) for a drug in a solid dosage form, the manner in which the drug is marked in accordance with paragraph C.07.008(a) and evidence that such manner does not alter the safety and efficacy of the drug;
(e) for a drug in a dosage form that is not solid, the manner in which the immediate container is marked in accordance with paragraph C.07.008(a); and
(f) a sample of the label for the drug that includes the information required by paragraph C.07.008(c).
Authorization
C.07.004 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s drug meets the requirements of the Act and these Regulations if
(a) the manufacturer has submitted to the Minister an application in accordance with section C.07.003 and a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;
(b) in respect of a new drug, an examination of the new drug submission or abbreviated new drug submission or supplement to either submission by the Minister demonstrates that the submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1;
(c) in respect of a drug that is not a new drug, a drug identification number has been assigned pursuant to section C.01.014.2; and
(d) the Minister is satisfied that the manufacturer and the drug comply with the Act and these Regulations.
C.07.005 Despite sections C.01.014, C.08.002 and C.08.003, a manufacturer may sell a drug under this Division if
(a) the Minister has notified the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the drug meets the requirements of the Act and these Regulations; and
(b) the manufacturer has received authorization under section 21.04 of the Patent Act.
C.07.006 Sections C.01.005 and C.01.014.1 to C.01.014.4 do not apply to new drugs sold under this Division.
Notice to Commissioner of Patents
C.07.007 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer’s drug authorized to be sold under this Division has ceased to meet the requirements of the Act and these Regulations.
Marking and Labelling
C.07.008 No person shall sell a drug under this Division unless
(a) the drug itself permanently bears the mark “XCL”, in the case of a drug in a solid dosage form, or the immediate container permanently bears the mark “XCL”, in the case of a drug in a dosage form that is not solid;
(b) the colour of the drug itself is significantly different from the colour of the version of the drug sold in Canada, in the case of a drug in a solid dosage form; and
(c) the label of the drug permanently bears the mark “XCL”, followed by the export tracking number assigned by the Minister under section C.07.009 and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.”
C.07.009 The Minister shall assign an export tracking number to each drug in respect of which the Minister has notified the Commissioner of Patents under section C.07.004.
Records
C.07.010 The manufacturer shall, with respect to a drug authorized to be sold under this Division,
(a) establish and maintain records, in a manner that enables an audit to be made, respecting the information described in section C.08.007; and
(b) provide to the Minister the reports referred to in section C.08.008.
Notice to Minister
C.07.011 The manufacturer shall notify the Minister in writing not less than 15 days before commencing the manufacture of the first lot of a drug authorized to be sold under this Division and not less than 15 days before the exportation of each subsequent lot of the drug.
Division 8
New Drugs
C.08.001 For the purposes of the Act and this Division, new drug means
(a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;
(b) a drug that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or
(c) a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug.
C.08.001.1 For the purposes of this Division,
Canadian reference product
Canadian reference product means
(a) a drug in respect of which a notice of compliance is issued pursuant to section C.08.004 and which is marketed in Canada by the innovator of the drug,
(b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued pursuant to section C.08.004 cannot be used for that purpose because it is no longer marketed in Canada, or
(c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a); (produit de référence canadien)
pharmaceutical equivalent
pharmaceutical equivalent means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; (équivalent pharmaceutique)
specifications
specifications means a detailed description of a new drug and of its ingredients and includes
(a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients,
(b) a detailed description of the methods used for testing and examining the ingredients, and
(c) a statement of the tolerances associated with the properties and qualities of the ingredients. (spécifications)
C.08.002 (1) No person shall sell or advertise a new drug unless
(a) the manufacturer of the new drug has filed with the Minister a new drug submission or an abbreviated new drug submission relating to the new drug that is satisfactory to the Minister;
(b) the Minister has issued, pursuant to section C.08.004, a notice of compliance to the manufacturer of the new drug in respect of the new drug submission or abbreviated new drug submission;
(c) the notice of compliance in respect of the submission has not been suspended pursuant to section C.08.006; and
(d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any labels, including package inserts, product brochures and file cards, intended for use in connection with that new drug, and a statement setting out the proposed date on which those labels will first be used.
(2) A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:
(a) a description of the new drug and a statement of its proper name or its common name if there is no proper name;
(b) a statement of the brand name of the new drug or the identifying name or code proposed for the new drug;
(c) a list of the ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients;
(d) a description of the plant and equipment to be used in the manufacture, preparation and packaging of the new drug;
(e) details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug;
(f) details of the tests to be applied to control the potency, purity, stability and safety of the new drug;
(g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended;
(h) substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended;
(i) a statement of the names and qualifications of all the investigators to whom the new drug has been sold;
(j) a draft of every label to be used in conjunction with the new drug;
(k) a statement of all the representations to be made for the promotion of the new drug respecting
(i) the recommended route of administration of the new drug,
(ii) the proposed dosage of the new drug,
(iii) the claims to be made for the new drug, and
(iv) the contra-indications and side effects of the new drug;
(l) a description of the dosage form in which it is proposed that the new drug be sold;
(m) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and
(n) for a drug intended for administration to food-producing animals, the withdrawal period of the new drug.
(3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of a new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:
(a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold;
(b) samples of the ingredients of the new drug;
(c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and
(d) any additional information or material respecting the safety and effectiveness of the new drug.
C.08.002.1 (1) A manufacturer of a new drug may file an abbreviated new drug submission for the new drug where, in comparison with a Canadian reference product,
(a) the new drug is the pharmaceutical equivalent of the Canadian reference product;
(b) the new drug is bioequivalent with the Canadian reference product, based on the pharmaceutical and, where the Minister considers it necessary, bioavailability characteristics;
(c) the route of administration of the new drug is the same as that of the Canadian reference product; and
(d) the conditions of use for the new drug fall within the conditions of use for the Canadian reference product.
(2) An abbreviated new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:
(a) the information and material described in paragraphs C.08.002(2)(a) to (f) and (j) to (l);
(b) information identifying the Canadian reference product used in any comparative studies conducted in connection with the submission;
(c) evidence from the comparative studies conducted in connection with the submission that the new drug is
(i) the pharmaceutical equivalent of the Canadian reference product, and
(ii) where the Minister considers it necessary on the basis of the pharmaceutical and, where applicable, bioavailability characteristics of the new drug, bioequivalent with the Canadian reference product as demonstrated using bioavailability studies, pharmacodynamic studies or clinical studies;
(d) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and
(e) for a drug intended for administration to food-producing animals, sufficient information to confirm that the withdrawal period is identical to that of the Canadian reference product.
(3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of an abbreviated new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:
(a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold;
(b) samples of the ingredients of the new drug;
(c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and
(d) any additional information or material respecting the safety and effectiveness of the new drug.
C.08.003 (1) Notwithstanding section C.08.002, no person shall sell a new drug in respect of which a notice of compliance has been issued to the manufacturer of that new drug and has not been suspended pursuant to section C.08.006, if any of the matters specified in subsection (2) are significantly different from the information or material contained in the new drug submission or abbreviated new drug submission, unless
(a) the manufacturer of the new drug has filed with the Minister
(i) a supplement to that new drug submission, or
(ii) a supplement to that abbreviated new drug submission;
(b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement;
(c) the notice of compliance in respect of the supplement has not been suspended pursuant to section C.08.006; and
(d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any label, including any package insert, product brochure and file card, intended for use in connection with the new drug, where a change with respect to any of the matters specified in subsection (2) is made that would require a change to the label.
(2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following:
(a) the description of the new drug;
(b) the brand name of the new drug or the identifying name or code proposed for the new drug;
(c) the specifications of the ingredients of the new drug;
(d) the plant and equipment used in manufacturing, preparation and packaging the new drug;
(e) the method of manufacture and the controls used in manufacturing, preparation and packaging the new drug;
(f) the tests applied to control the potency, purity, stability and safety of the new drug;
(g) the labels used in connection with the new drug;
(h) the representations made with regard to the new drug respecting
(i) the recommended route of administration of the new drug,
(ii) the dosage of the new drug,
(iii) the claims made for the new drug,
(iv) the contra-indications and side effects of the new drug, and
(v) the withdrawal period of the new drug; and
(i) the dosage form in which it is proposed that the new drug be sold.
(3) A supplement to a new drug submission or to an abbreviated new drug submission, with respect to the matters that are significantly different from those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters.
C.08.003.1 The Minister may examine any information or material filed with the Minister by any person pursuant to Division 5 or section C.08.002, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 to establish the safety and effectiveness of the new drug for which the submission or supplement has been filed.
C.08.004 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission,
(a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or
(b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.
(2) Where a new drug submission or abbreviated new drug submission or a supplement to either submission does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material.
(3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission,
(a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or
(b) if that submission or supplement does not comply with the requirements of section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply.
(4) A notice of compliance issued in respect of a new drug on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.
C.08.004.1 (1) The following definitions apply in this section.
innovative drug
innovative drug means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. (drogue innovante)
pediatric populations
pediatric populations means the following groups: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age. (population pédiatrique)
(2) This section applies to the implementation of Article 1711 of the North American Free Trade Agreement, as defined in the definition Agreement in subsection 2(1) of the North American Free Trade Agreement Implementation Act, and of paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the World Trade Organization Agreement, as defined in the definition Agreement in subsection 2(1) of the World Trade Organization Agreement Implementation Act.
(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug,
(a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and
(b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.
(4) The period specified in paragraph (3)(b) is lengthened to eight years and six months if
(a) the innovator provides the Minister with the description and results of clinical trials relating to the use of the innovative drug in relevant pediatric populations in its first new drug submission for the innovative drug or in any supplement to that submission that is filed within five years after the issuance of the first notice of compliance for that innovative drug; and
(b) before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug, the Minister determines that the clinical trials were designed and conducted for the purpose of increasing knowledge of the use of the innovative drug in those pediatric populations and this knowledge would there-by provide a health benefit to members of those populations.
(5) Subsection (3) does not apply if the innovative drug is not being marketed in Canada.
(6) Paragraph (3)(a) does not apply to a subsequent manufacturer if the innovator consents to the filing of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission by the subsequent manufacturer before the end of the period of six years specified in that paragraph.
(7) Paragraph (3)(a) does not apply to a subsequent manufacturer if the manufacturer files an application for authorization to sell its new drug under section C.07.003.
(8) Paragraph (3)(b) does not apply to a subsequent manufacturer if the innovator consents to the issuance of a notice of compliance to the subsequent manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4).
(9) The Minister shall maintain a register of innovative drugs that includes information relating to the matters specified in subsections (3) and (4).
C.08.005 (1) Subject to subsection (1.1) and notwithstanding sections C.08.002 and C.08.003, a manufacturer of a new drug may sell it to a qualified investigator to be used solely for the purpose of clinical testing to obtain evidence with respect to the safety, dosage and effectiveness of that new drug, when the following conditions are met:
(a) before the sale, the manufacturer has filed with the Minister, in compliance with section C.08.005.1, a preclinical submission containing information and material respecting
(i) the brand name of the new drug or the identifying name or code proposed for the new drug,
(ii) the chemical structure or other specific identification of the composition of the new drug,
(iii) the source of the new drug,
(iv) a detailed protocol of the clinical testing,
(v) the results of investigations made to support the clinical use of the new drug,
(vi) the contra-indications and precautions known in respect of the new drug and the suggested treatment of overdosage of the new drug,
(vii) all ingredients of the new drug, stated quantitatively,
(viii) the methods, equipment, plant and controls used in the manufacture, processing and packaging of the new drug,
(ix) the tests applied to control the potency, purity and safety of the new drug, and
(x) the names and qualifications of all investigators to whom the drug is to be sold and the names of all institutions in which the clinical testing is to be carried out;
(b) the Director has not, within 60 days after the date of receipt of the preclinical submission, sent by registered mail to the manufacturer a notice in respect of that new drug indicating that the preclinical submission is not satisfactory;
(c) all inner labels and outer labels used in conjunction with the sale of the new drug to qualified investigators carry the statements
(i) “Investigational Drug” or “Drogue de recherche”, and
(ii) “To Be Used By Qualified Investigators Only” or “Réservée uniquement à l’usage de chercheurs compétents”;
(d) before the sale, the manufacturer ascertains that every qualified investigator to whom the new drug is to be sold
(i) has the facilities for the clinical testing to be conducted by the investigator, and
(ii) has received the information and material referred to in subparagraphs (a)(i) to (vi); and
(e) every qualified investigator to whom the new drug is to be sold has agreed in writing with the manufacturer that the investigator will
(i) not use the new drug or permit it to be used other than for clinical testing,
(ii) not permit the new drug to be used by any person other than the investigator except under the investigator’s direction,
(iii) report immediately to that manufacturer and, if so required by the Director, report to the Director all serious adverse reactions encountered during the clinical testing, and
(iv) account to the manufacturer for all quantities of the new drug received, where so requested by the manufacturer.
(1.1) This section applies only in respect of a new drug for veterinary use.
(2) Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator unless that manufacturer has, in respect of all previous sales of that new drug to any qualified investigator,
(a) kept accurate records of the distribution of that new drug and of the results of the clinical testing and has made those records available to the Director for inspection on the request of the Director; and
(b) immediately reported to the Director all information he has obtained with respect to serious adverse reactions.
(3) The Minister may notify the manufacturer of a new drug that sales of that new drug to qualified investigators are prohibited if, in the opinion of the Minister, it is in the interest of public health to do so.
(4) Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator if the Minister has notified the manufacturer of that drug that such sales are prohibited.
(5) Paragraph (1)(c) does not apply to a radiopharmaceutical as defined in section C.03.201 or to a component or kit as defined in section C.03.205.
C.08.005.1 (1) Every manufacturer who files a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission, a supplement to an abbreviated new drug submission or a submission for the clinical testing of a new drug for veterinary use shall, in addition to any information and material that is required under section C.08.002, C.08.003 and C.08.005, include in the submission or supplement
(a) a copy of all clinical case reports respecting any subject of a study included in the submission or supplement if that subject has died, suffered a serious adverse reaction or an unexpected adverse reaction, or the study, insofar as it relates to this subject, has not been completed;
(b) a sectional report in respect of each human, animal and in vitro study included in the submission or supplement;
(c) a comprehensive summary of each human, animal and in vitro study referred to or included in the submission or supplement; and
(d) a submission certificate in respect of all information and material contained in the submission or supplement and any additional information or material filed to amend the submission or supplement.
(2) A sectional report referred to in paragraph (1)(b) shall include
(a) a summary of each study included in the submission or supplement;
(b) a summary of any additional information or material filed to amend the submission or supplement; and
(c) where raw data is available to the manufacturer in respect of a study,
(i) a summary of the data,
(ii) a cross-referencing of the data to the relevant portions of the sectional report,
(iii) a description of the conditions under which the experiments from which the data were obtained were conducted,
(iv) the details of the data treatment process, and
(v) the results and conclusions of the study.
(3) The comprehensive summary referred to in paragraph (1)(c) shall include a summary of the methods used, results obtained and conclusions arrived at in respect of all studies referred to or included in the submission or supplement and shall be cross-referenced to the relevant portions of the sectional reports.
(4) The submission certificate referred to in paragraph (1)(d) shall
(a) certify that all information and material included in the submission or supplement and any additional information or material filed to amend the submission or supplement are accurate and complete, and that the sectional reports and the comprehensive summary correctly represent the information and material referred to or included in the submission or supplement; and
(b) be signed and dated by
(i) the senior executive officer in Canada of the manufacturer filing the submission or supplement, and
(ii) the senior medical or scientific officer of the manufacturer.
(5) No person shall sign a submission certificate if a sectional report, comprehensive summary or any information or material included in the submission or supplement, or any additional information and material filed to amend the submission or supplement,
(a) is false or misleading; or
(b) contains omissions that may affect its accuracy and completeness.
(6) Every manufacturer who has filed a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission, a supplement to an abbreviated new drug submission or a submission for the clinical testing of a new drug for veterinary use, and has any relating clinical case reports or raw data that were not included therein, shall keep those reports or data and shall, within 30 days after receiving a written request from the Minister, submit them to the Minister.
C.08.006 (1) For the purposes of this section, evidence or new information obtained by the Minister includes any information or material filed by any person pursuant to Division 5 or section C.08.002, C.08.002.1, C.08.003, C.08.005 or C.08.005.1.
(2) The Minister may, by notice to a manufacturer, suspend, for a definite or indefinite period, a notice of compliance issued to that manufacturer in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission, if the Minister considers
(a) that the drug is not safe for the use represented in the submission or supplement, as shown by evidence obtained from
(i) clinical or other experience not reported in the submission or supplement or not available to the Minister at the time the notice of compliance was issued, or
(ii) tests by new methods or tests by methods not reasonably applicable at the time the notice of compliance was issued;
(b) that, upon the basis of new information obtained after the issuance of the notice of compliance, there is lack of substantial evidence that the drug will have the effect it is represented to have under the conditions of use prescribed, recommended or proposed by the manufacturer;
(c) that the submission or supplement contained an untrue statement of material fact;
(d) that the manufacturer has failed to establish a system for maintaining required records or has repeatedly or deliberately failed to maintain such records;
(e) that, on the basis of new information obtained after the issuance of the notice of compliance, the methods, equipment, plant and controls used in the manufacturing, processing and packaging of the drug are inadequate to assure and preserve the identity, strength, quality or purity of the new drug; or
(f) that, on the basis of new information obtained after the issuance of the notice of compliance, the labelling of the drug is false or misleading or incomplete in any particular and that this defect was not corrected by the manufacturer upon receipt of a written notice from the Director specifying the respect in which the labelling is false or misleading or incomplete.
C.08.007 Where a manufacturer has received a notice of compliance issued in respect of a new drug submission or abbreviated new drug submission or a supplement to either submission, the manufacturer shall establish and maintain records, in a manner that enables an audit to be made, respecting
(a) animal or clinical experience, studies, investigations and tests conducted by the manufacturer or reported to him by any person concerning that new drug;
(b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that new drug;
(c) experience, investigations, studies and tests involving the chemical or physical properties or any other properties of that new drug;
(d) any substitution of another substance for that new drug or any mixing of another substance with that new drug;
(e) any error in the labelling of that new drug or in the use of the labels designed for that new drug;
(f) any bacteriological or any significant chemical or physical or other change or deterioration in any lot of that new drug;
(g) any failure of one or more distributed lots of the new drug to meet the specifications established for that new drug in the submission or supplement; and
(h) any unusual failure in efficacy of that new drug.
(i) [Repealed, SOR/95-521, s. 3]
C.08.008 No manufacturer shall sell a new drug unless the manufacturer has, with respect to all the manufacturer’s previous sales of that new drug, furnished to the Minister
(a) on request, reports of all records respecting the information described in paragraphs C.08.007(a) to (c);
(b) immediately on receipt by the manufacturer, reports of all records respecting the information described in paragraphs C.08.007(d) to (f); and
(c) within 15 days after the receipt by the manufacturer of information referred to in paragraphs C.08.007(g) and (h), a report on the information received.
C.08.009 (1) Where the Minister has decided
(a) to notify the manufacturer of a new drug for veterinary use that the sale of that drug to qualified investigators is prohibited, or
(b) to suspend a notice of compliance issued in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission,
the manufacturer, if dissatisfied with that decision, may require the Minister to provide him with the reasons for the decision.
(2) Where the manufacturer has received the reasons for a decision of the Minister pursuant to subsection (1), he may require the Minister to refer that decision to a New Drug Committee and thereupon shall provide the Minister with a statement of the reasons for his dissatisfaction and any information and material upon which he relies in support of those reasons.
(3) Where the Minister has been required to refer a decision to a New Drug Committee pursuant to subsection (2), he shall appoint a member of the New Drug Committee, the dissatisfied manufacturer shall appoint a member of the New Drug Committee and the two members so appointed shall appoint a third member of the New Drug Committee who shall be chairman, or, if they are unable to do so within a reasonable time, the Minister shall appoint a third member of the New Drug Committee who shall be chairman.
(4) Any person who is in the full-time employment of the Department or in the full-time employment of the dissatisfied manufacturer shall not be appointed a member of a New Drug Committee.
(4.1) A member of a New Drug Committee shall, on appointment, sign an undertaking not to disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).
(5) The Minister shall pay the reasonable fees and costs incurred by the member of the New Drug Committee appointed by the Minister, and the dissatisfied manufacturer shall pay the reasonable fees and costs incurred by the member appointed by the dissatisfied manufacturer, and the Minister and the dissatisfied manufacturer shall each pay half of the reasonable fees and costs incurred by the chairman.
(6) The New Drug Committee formed pursuant to subsection (3) shall consider the reasons for the decision of the Minister, the reasons for the dissatisfaction of the dissatisfied manufacturer and any information or material in support of the reasons of the Minister or the dissatisfied manufacturer and may consider other evidence, material, information or representations.
(7) The New Drug Committee formed pursuant to subsection (3) shall report its findings and recommendations to the Minister.
(7.1) No member of a New Drug Committee shall disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).
(8) Where the Minister has received the findings and recommendations of a New Drug Committee, he may reconsider the decision to which those findings and recommendations relate.
Sale of New Drug for Emergency Treatment
C.08.010 (1) The Director may issue a letter of authorization authorizing the sale of a quantity of a new drug for human or veterinary use to a practitioner named in the letter of authorization for use in the emergency treatment of a patient under the care of that practitioner, if
(a) the practitioner has supplied to the Director information concerning
(i) the medical emergency for which the drug is required,
(ii) the data in the possession of the practitioner with respect to the use, safety and efficacy of that drug,
(iii) the names of all institutions in which the drug is to be used, and
(iv) such other data as the Director may require; and
(b) the practitioner has agreed to
(i) report to the manufacturer of the new drug and to the Director on the results of the use of the drug in the medical emergency, including information respecting any adverse reactions encountered, and
(ii) account to the Director on request for all quantities of the drug received by him.
(2) The Director shall, in any letter of authorization issued pursuant to subsection (1), state
(a) the name of the practitioner to whom the new drug may be sold;
(b) the medical emergency in respect of which the new drug may be sold; and
(c) the quantity of the new drug that may be sold to that practitioner for that emergency.
C.08.011 (1) Notwithstanding section C.08.002, a manufacturer may sell to a practitioner named in a letter of authorization issued pursuant to section C.08.010, a quantity of the new drug named in that letter that does not exceed the quantity specified in the letter.
(2) A sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations.
Sale of Medicated Feeds
C.08.012 (1) Notwithstanding anything in this Division, a person may sell, pursuant to a written prescription of a veterinary practitioner, a medicated feed if
(a) as regards the drug or drugs used as the medicating ingredient of the medicated feed,
(i) the Director has assigned a drug identification number pursuant to section C.01.014.2, or
(ii) the sale is permitted by section C.08.005, C.08.011 or C.08.013;
(b) the medicated feed is for the treatment of animals under the direct care of the veterinary practitioner who signed the prescription;
(c) the medicated feed is for therapeutic purposes only; and
(d) the written prescription contains the following information:
(i) the name and address of the person named on the prescription as the person for whom the medicated feed is to be mixed,
(ii) the species, production type and age or weight of the animals to be treated with the medicated feed,
(iii) the type and amount of medicated feed to be mixed,
(iv) the proper name, or the common name if there is no proper name, of the drug or each of the drugs, as the case may be, to be used as medicating ingredients in the preparation of the medicated feed, and the dosage levels of those medicating ingredients,
(v) any special mixing instructions, and
(vi) labelling instructions including
(A) feeding instructions,
(B) a warning statement respecting the withdrawal period to be observed following the use of the medicated feed, and
(C) where applicable, cautions with respect to animal health or to the handling or storage of the medicated feed.
(2) For the purpose of this section, medicated feed has the same meaning as in the Feeds Regulations.
Experimental Studies
Conditions of Sale
C.08.013 (1) Notwithstanding anything in this Division, a person may sell a new drug proposed for use in animals to an experimental studies investigator in a quantity specified by the Director for the purpose of conducting an experimental study in animals if
(a) the experimental studies investigator has been issued an experimental studies certificate pursuant to subsection C.08.015(1) and the certificate has not been suspended or cancelled pursuant to section C.08.018; and
(b) the drug is labelled in accordance with subsection C.08.016(1).
(2) For the purposes of this section and sections C.08.014 to C.08.018,
experimental studies certificate
experimental studies certificate means a certificate issued pursuant to subsection C.08.015(1); (certificat d’études expérimentales)
experimental studies investigator
experimental studies investigator means a person named as the investigator in an experimental studies certificate; (expert en études expérimentales)
experimental study
experimental study means a limited test of a new drug in animals carried out by an experimental studies investigator. (étude expérimentale)
Experimental Studies Certificate
C.08.014 (1) For the purpose of obtaining an experimental studies certificate, an applicant shall submit to the Director, in writing, the following information and material:
(a) the brand name of the new drug or the identifying name or code proposed for the new drug;
(b) the objectives and an outline of the proposed experimental study of the new drug;
(c) the species, number and production type of animals in respect of which the new drug is to be administered;
(d) the name and address of the manufacturer of the new drug;
(e) the address of the premises in which the experimental study is to be conducted;
(f) a description of the facilities to be used to conduct the experimental study;
(g) the name, address and qualifications of the proposed experimental studies investigator;
(h) the chemical structure, if known, and the relevant compositional characteristics of the new drug;
(i) the proposed quantity of the new drug to be used for the experimental study;
(j) the results of any toxicological or pharmacological studies that may have been conducted with the new drug;
(k) the written agreement referred to in subsection (2); and
(l) such other information and material as the Director may require.
(2) Where a food-producing animal is involved in an experimental study, the applicant referred to in subsection (1) shall, for the purposes of obtaining an experimental studies certificate, obtain from the owner of the animals, or from a person authorized by the owner, a written agreement not to sell the animal or any products from it without prior authorization from the experimental studies investigator.
(3) The Director may request the manufacturer of a new drug to submit to him samples of the new drug or of any ingredient of the drug and, in satisfactory form and manner, any other information that the Director requests and where such samples or information are not submitted, the Director may refuse to issue an experimental studies certificate.
C.08.015 (1) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is satisfied that
(a) the applicant is qualified as an experimental studies investigator for the purposes of the proposed experimental study,
(b) the facilities for the conduct of the experimental study are adequate for the purposes of the proposed experimental study, and
(c) the proposed experimental study can be conducted without undue foreseeable risk to humans or animals,
the Director shall issue an experimental studies certificate for the purposes of the proposed experimental study and shall specify therein the quantity of the new drug that may be sold to the experimental studies investigator.
(2) Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is not satisfied that the requirements of paragraphs (1)(a), (b) and (c) have been met, he shall refuse to issue an experimental studies certificate.
Labelling
C.08.016 (1) The label of a new drug that is sold pursuant to section C.08.013 shall show
(a) the brand name of the new drug or the identifying name or code proposed for the new drug;
(b) a warning statement to the effect that the drug is for use only in an experimental study in animals;
(c) the lot number of the drug;
(d) the name and address of the manufacturer of the drug; and
(e) the name of the person to whom the drug has been supplied.
(2) Sections C.01.004, C.01.005 and C.01.014 do not apply to a drug that is sold pursuant to section C.08.013 and labelled in accordance with subsection (1).
Conditions of Experimental Study
C.08.017 An experimental studies investigator shall
(a) use the new drug only in accordance with the outline of the experimental study;
(b) report immediately to the Director all serious adverse drug reactions associated with the use of the new drug;
(c) report promptly to the Director, on request, the results of the experimental study;
(d) return to the manufacturer, on request, all quantities of the new drug not used in the experimental study;
(e) maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Director;
(f) report promptly to the Director any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014(2); and
(g) account to the Director, on request, for all quantities of the new drug received by him.
Suspension or Cancellation of Experimental Studies Certificate
C.08.018 (1) Where the Director is of the opinion that it is necessary in order to safeguard animal health or public health or to promote public safety, he may suspend for a definite or indefinite period or cancel an experimental studies certificate.
(2) Without limiting the generality of subsection (1), the Director may suspend or cancel an experimental studies certificate if
(a) the information and material submitted pursuant to section C.08.014 contains an untrue statement or contains any omission concerning the properties of the drug that were known or ought reasonably to have been known to the manufacturer or the experimental studies investigator;
(b) the labelling of the new drug is, at any time, false, misleading, deceptive or incomplete;
(c) the qualifications of the experimental studies investigator prove to be inadequate;
(d) there is evidence that the experimental studies investigator has not complied with the conditions referred to in section C.08.017; or
(e) an action of the manufacturer in respect of the new drug has resulted in his conviction for a violation of section C.08.002.
Division 9
Non-prescription Drugs
C.09.001 This Division does not apply to
(a) a drug that is required by these Regulations or the Narcotic Control Regulations to be sold only on prescription; or
(b) a drug for use exclusively in animals.
Analgesics
General
C.09.010 No manufacturer or importer shall, after June 30, 1986, sell a drug for analgesia that contains a combination of
(a) a salt or derivative of salicylic acid with another salt or derivative of salicylic acid or with salicylamide; or
(b) acetaminophen with a salt or derivative of salicylic acid or with salicylamide.
C.09.011 Each label of a drug that is intended for internal use and contains acetaminophen, salicylic acid or a salt or derivative thereof shall, after June 30, 1986, carry a caution
(a) to consult a physician if the underlying condition requires continued use for more than five days; and
(b) that it is hazardous to exceed the maximum recommended dose unless advised by a physician.
C.09.012 Each label of a drug that is intended for internal use and contains salicylic acid or a salt or derivative thereof shall after June 30, 1986, carry a warning statement to consult a physician before taking the drug during the last three months of pregnancy or when nursing.
Acetaminophen
C.09.020 (1) The adult standard dosage unit of acetaminophen shall be 325 mg.
(2) The children’s standard dosage units of acetaminophen shall be 80 mg or 160 mg.
C.09.021 (1) In this Division, acetaminophen product means a drug that contains
(a) acetaminophen as a single medicinal ingredient; or
(b) acetaminophen in combination with caffeine.
(2) No manufacturer or importer shall sell an acetaminophen product unless it meets the requirements of this Division.
(3) [Repealed, SOR/90-587, s. 5]
C.09.022 (1) Subject to subsections (2) to (4), an acetaminophen product sold in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of acetaminophen per individual dosage form.
(2) An acetaminophen product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain 500 mg of acetaminophen per individual dosage form if it has a label that states that it is not a standard dosage unit product.
(3) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration may contain 325 mg of acetaminophen for immediate release and another 325 mg for subsequent release, if it has a label that states that it is not a standard dosage unit product.
(4) An acetaminophen product sold in the form of a tablet, capsule or other solid dosage form that is intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per individual dosage form.
(5) An acetaminophen product in the form of a liquid that is intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit of acetaminophen per millilitre of the product.
(6) A package of an acetaminophen product described in subsection (5) shall be accompanied by a measuring device capable of accurately delivering 0.5 mL of the product.
(7) An acetaminophen product in the form of a liquid that is not intended to be taken as drops and that is specially recommended for children shall contain one children’s standard dosage unit per teaspoon of the product.
(8) An acetaminophen product in the form of a liquid shall contain one adult standard dosage unit of acetaminophen per teaspoon of the product.
Salicylates
C.09.030 (1) The adult standard dosage unit of a salicylate shall be
(a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 325 mg; and
(b) in the case of choline salicylate, 435 mg.
(2) The children’s standard dosage unit of a salicylate shall be
(a) in the case of acetylsalicylic acid, sodium salicylate and magnesium salicylate, 80 mg; and
(b) in the case of choline salicylate, 110 mg.
C.09.031 (1) In this Division, salicylate product means a drug that contains
(a) a salt or derivative of salicylic acid as a single medicinal ingredient;
(b) a salt or derivative of salicylic acid in combination with caffeine;
(c) a salt or derivative of salicylic acid in combination with one or more buffering agents or antacids; or
(d) a salt or derivative of salicylic acid in combination with caffeine and one or more buffering agents or antacids.
(2) No manufacturer or importer shall sell a salicylate product after June 30, 1986 unless it meets the requirements of this Division.
(3) No manufacturer or importer shall, until June 30, 1986, sell a salicylate product in a dosage unit other than one mentioned in this Division, unless the salicylate product was legally available for sale in Canada on February 1, 1984.
C.09.032 (1) Subject to subsections (2) and (3) and section C.09.035, a salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration shall contain one adult standard dosage unit of a salicylate per individual dosage form.
(2) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain
(a) 500 mg of acetylsalicylic acid, sodium salicylate or magnesium salicylate, or
(b) 670 mg of choline salicylate
per individual dosage form if it has a label that states that it is not a standard dosage unit product.
(3) A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration may contain
(a) two adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains two adult standard dosage units; and
(b) three adult standard dosage units of a salicylate per individual dosage form if the label of the salicylate product states that each individual dosage form contains three adult standard dosage units.
C.09.033 (1) Subject to subsection (2), a salicylate product in the form of a liquid shall contain one adult standard dosage unit of a salicylate per teaspoon.
(2) A salicylate product in the form of a liquid may contain
(a) two adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains two adult standard dosage units; and
(b) three adult standard dosage units of a salicylate per teaspoon if the label of the salicylate product states that each teaspoon of the product contains three adult standard dosage units.
C.09.034 A salicylate product that is claimed to be buffered shall provide at least 1.9 milliequivalents of acid neutralizing capacity per adult standard dosage unit of a salicylate.
C.09.035 A salicylate product in the form of a tablet, capsule or other solid dosage form intended for oral administration and that is specially recommended for children shall contain one children’s standard dosage unit of a salicylate per individual dosage form.
[Repealed, SOR/98-423, s. 9]
Division 10
PART D
Vitamins, Minerals and Amino Acids
D.01.001 (1) In this Part,
advertise
advertise means to advertise to the general public; (faire de la publicité)
brand name
brand name means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,
(a) that is assigned to the drug by its manufacturer,
(b) under which the drug is sold or advertised, and
(c) that is used to distinguish the drug; (marque nominative)
common name
common name means, with reference to a salt or derivative of a vitamin, the name in English or French by which the salt or derivative is
(a) commonly known, and
(b) designated in scientific or technical journals; (nom usuel)
prepackaged product
prepackaged product means any food that is contained in a package in the manner in which it is ordinarily sold to, or used or purchased by, a person; (produit préemballé)
reasonable daily intake
reasonable daily intake, in respect of a food named in an item in Column I of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne normale)
recommended daily intake
recommended daily intake means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in
(a) column II of Table I to Division 1 and column II of Table I to Division 2, for foods intended for persons 2 years of age or older, and
(b) column III of Table I to Division l and column III of Table I to Division 2, for foods intended for infants and children less than 2 years of age; (apport quotidien recommandé)
testimonial
testimonial, with respect to a food or drug that is represented as containing a vitamin, mineral nutrient or mineral, means any dramatized or undramatized pictorial, written or oral representation as to the result that is, has been or may be produced by the addition to a person’s diet of that vitamin, mineral nutrient or mineral, as the case may be; (témoignage)
weighted recommended nutrient intake
weighted recommended nutrient intake means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in Table II to Division 1 and Table II to Division 2. (apport nutritionnel recommandé pondéré)
(2) For the purposes of this Part, a serving of stated size of a food shall be
(a) based on the food as offered for sale; and
(b) expressed
(i) in grams, if
(A) the net quantity of the food is declared on the label by weight or by count, or
(B) the food is set out in column 1 of item 78, 149 or 150 of Schedule M, and
(ii) in millilitres, if the net quantity of the food is declared on the label by volume, except in the case of a food referred to in clause (i)(B).
(3) A serving of stated size shall be the net quantity of the food in the package if
(a) the quantity of food can reasonably be consumed by one person at a single eating occasion;
(b) the reference amount, as defined in section B.01.001, of the food is less than 100 g or 100 mL and the package contains less than 200% of that amount; or
(c) the reference amount, as defined in section B.01.001, of the food is 100 g or 100 mL or more and the package contains 150% or less of that amount.
DIVISION 1
Vitamins In Foods
D.01.002 (1) In this Division, vitamin means any of the following vitamins:
(a) vitamin A;
(b) vitamin D;
(c) vitamin E;
(d) vitamin K;
(e) vitamin C;
(f) thiamin, thiamine or vitamin B1;
(g) riboflavin or vitamin B2;
(h) niacin;
(i) vitamin B6;
(j) folacin or folate;
(k) vitamin B12;
(l) pantothenic acid or pantothenate; and
(m) biotin. (vitamine)
(2) For the purposes of this Division, no expression, other than an expression set out in subsection (1), shall be used to declare the vitamin content of a food.
(3) This Division applies only in respect of foods represented as containing a vitamin for use in human nutrition.
D.01.003 (1) For the purposes of these Regulations, the vitamin content of a food, other than a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute, shall be determined
(a) in the case of vitamin A, in terms of the content of retinol and its derivatives and beta-carotene, expressed as retinol equivalents (RE) on the basis of the following relationships:
(i) 1 RE = 1 microgram retinol, and
(ii) 1 RE = 6 micrograms beta-carotene;
(b) in the case of vitamin D, in terms of the content of cholecalciferol and ergocalciferol, expressed in micrograms;
(c) in the case of vitamin E, in terms of the content of d-alpha-tocopherol and dl-alpha-tocopherol and their derivatives, expressed in milligrams on the basis of the following relationships:
(i) one milligram d-alpha-tocopherol = one milligram vitamin E, and
(ii) one milligram dl-alpha-tocopherol = 0.74 milligram vitamin E;
(d) in the case of vitamin K, in terms of the content of phylloquinone and menaquinones, expressed in micrograms;
(e) in the case of vitamin C, in terms of the content of L-ascorbic acid and L-dehydroascorbic acid and their derivatives, calculated in milligram equivalents of L-ascorbic acid and expressed in milligrams;
(f) in the case of thiamin, thiamine or vitamin B1, and its derivatives, in terms of the content of thiamin, expressed in milligrams;
(g) in the case of riboflavin or vitamin B2 and its derivatives, in terms of the content of riboflavin, expressed in milligrams;
(h) in the case of niacin, in terms of the content of niacin and its derivatives, calculated in milligrams of nicotinic acid, plus the content of tryptophan, calculated in milligrams and divided by 60, with the total expressed as niacin equivalents (NE);
(i) in the case of vitamin B6, in terms of the content of pyridoxine, pyridoxal and pyridoxamine and their derivatives, calculated in milligram equivalents of pyridoxine and expressed in milligrams;
(j) in the case of folacin, in terms of the content of folic acid (pteroylmonoglutamic acid) and related compounds exhibiting the biological activity of folic acid, calculated in microgram equivalents of folic acid and expressed in micrograms;
(k) in the case of vitamin B12, in terms of the content of cyanocobalamin and related compounds exhibiting the biological activity of cyanocobalamin, calculated in microgram equivalents of cyanocobalamin and expressed in micrograms;
(l) in the case of pantothenic acid or pantothenate, in terms of the content of d-pantothenic acid, expressed in milligrams; and
(m) in the case of biotin, in terms of the content of biotin, expressed in milligrams.
(2) For the purpose of paragraph (1)(h), the content of tryptophan may be calculated
(a) where the protein originates from a food that contains protein from more than one source or from a source other than milk, meat, poultry, fish or eggs, as constituting 1.1 per cent of the protein;
(b) where the protein originates from milk, meat, poultry or fish, as constituting 1.3 per cent of the protein; and
(c) where the protein originates from eggs, as constituting 1.5 per cent of the protein.
D.01.004 (1) No person shall, on the label of or in any advertisement for a food, other than a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute, make a statement or claim concerning the vitamin content of the food unless
(a) the vitamin is set out in column I of Table I to this Division;
(b) the percentage of the recommended daily intake of the vitamin, per serving of stated size, is 5% or more; and
(c) the vitamin content is declared on the label or in the advertisement as a percentage of the daily value, per serving of stated size.
(2) If a statement or claim described in subsection (1) is made in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the percentage of the daily value, per serving of stated size, shall,
(a) in the case of an advertisement, other than a radio or television advertisement, be
(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and
(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;
(b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim; or
(c) in the case of a television advertisement, be communicated
(i) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions, or
(ii) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.
(3) The percentage of the daily value, per serving of stated size, that is communicated in the visual mode of a television advertisement in accordance with subparagraph (2)(c)(ii) shall
(a) appear concurrently with and for at least the same amount of time as the statement or claim;
(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and
(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.
(4) Paragraph (1)(b) does not apply in respect of a declaration of the vitamin content in a nutrition facts table.
(5) Paragraph (1)(c) does not apply in respect of a declaration of the biotin content as required by subparagraph B.24.202(a)(v).
D.01.005 [Repealed, SOR/2003-11, s. 29]
D.01.006 No person shall, on the label of or in any advertisement for a food, make any claim concerning the action or effects of a vitamin contained in the food, except to the effect that the vitamin
(a) is a factor in the maintenance of good health; and
(b) is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development.
D.01.007 (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a vitamin, no person shall, on the label of or in any advertisement for the prepackaged product, make a statement or claim concerning the vitamin as a component of that ingredient unless
(a) despite subsection B.01.008(6), the vitamin is declared by its common name immediately following the declaration of the ingredient in such a manner as to indicate that it is a component of that ingredient; and
(b) all components of the ingredient are declared.
(2) Paragraph (1)(b) does not apply to flour used as an ingredient in the manufacture of a prepackaged product referred to in subsection (1).
D.01.008 [Repealed, SOR/88-559, s. 32]
D.01.009 Subject to section D.01.010, no person shall sell a food to which any of the following vitamins have been added unless a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than,
(a) in the case of vitamin A, 1,600 International Units;
(b) in the case of thiamine, 0.6 milligram;
(c) in the case of riboflavin, 1.0 milligram;
(d) in the case of niacin or niacinamide, six milligrams;
(e) in the case of ascorbic acid, 20 milligrams; and
(f) in the case of vitamin D, 300 International Units.
D.01.010 Where a food to which a vitamin has been added is represented as being solely for use in the feeding of children under two years of age, no person shall sell such food unless a reasonable daily intake of that food by a child under two years of age would result in the daily intake by the child of not less than,
(a) in the case of vitamin A, 1,000 International Units;
(b) in the case of thiamine, 0.4 milligram;
(c) in the case of riboflavin, 0.6 milligram;
(d) in the case of niacin or niacinamide, four milligrams;
(e) in the case of pyridoxine, 0.6 milligram;
(f) in the case of ascorbic acid, 20 milligrams;
(g) in the case of vitamin D, 300 International Units; and
(h) in the case of vitamin E, five International Units.
D.01.011 No person shall sell a food to which any of the following vitamins have been added if a reasonable daily intake of that food by a person would result in the daily intake by such person of more than,
(a) in the case of vitamin A, 2,500 International Units;
(b) in the case of thiamine, two milligrams;
(c) in the case of riboflavin, three milligrams;
(d) in the case of niacin or niacinamide, 20 milligrams;
(e) in the case of pyridoxine, 1.5 milligrams;
(f) in the case of ascorbic acid, 60 milligrams;
(g) in the case of vitamin D, 400 International Units; and
(h) in the case of vitamin E, 15 International Units.
D.01.012 No person shall, in advertising a food that is represented as containing a vitamin or on a label of such food,
(a) give any assurance or guarantee of any kind with respect to the result that may be, has been or will be obtained by the addition of the vitamin to a person’s diet; or
(b) refer to, reproduce or quote any testimonial.
D.01.013 [Repealed, SOR/2003-11, s. 31]
TABLE I
Recommended Daily Intake
ItemColumn IColumn IIColumn IIIVitaminUnitsIntake of persons 2 years of age or olderIntake of infants or children less than 2 years of age1Vitamin A(RE)10004002Vitamin D(µg)5103Vitamin E(mg)1034Vitamin C(mg)60205Thiamin, thiamine or vitamin B1(mg)1.30.456Riboflavin or vitamin B2(mg)1.60.557Niacin(NE)2388Vitamin B6(mg)1.80.79Folacin or folate(µg)2206510Vitamin B12(µg)20.311Pantothenic acid or pantothenate(mg)7212Vitamin K(µg)803013Biotin(µg)308TABLE II
Weighted Recommended Nutrient Intake
ItemColumn IColumn IIColumn IIIVitaminUnitsAmount1Biotinmicrograms902Folacinmicrograms1953Niacinniacin equivalents164Pantothenic Acidmilligrams5.05Riboflavinmilligrams1.26Thiaminemilligrams1.07Vitamin Aretinol equivalents8708Vitamin B6milligrams1.09Vitamin B12micrograms1.010Vitamin Cmilligrams3411Vitamin Dmicrograms3.012Vitamin Emilligrams7.0DIVISION 2
Mineral Nutrients In Foods
D.02.001 (1) In this Division, mineral nutrient means any of the following chemical elements, whether alone or in a compound with one or more other chemical elements:
(a) sodium;
(b) potassium;
(c) calcium;
(d) phosphorus;
(e) magnesium;
(f) iron;
(g) zinc;
(h) iodide;
(i) chloride;
(j) copper;
(k) fluoride;
(l) manganese;
(m) chromium;
(n) selenium;
(o) cobalt;
(p) molybdenum;
(q) tin;
(r) vanadium;
(s) silicon; and
(t) nickel. (minéral nutritif)
(2) This Division applies only in respect of foods that are represented as containing a mineral nutrient for use in human nutrition.
D.02.002 (1) No person shall, on the label of or in any advertisement for a food, other than salt for table or general household use containing added iodide, prepackaged water and ice, a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute, make a statement or claim concerning the mineral nutrient content of the food unless
(a) the mineral nutrient is set out in column I of Table I to this Division;
(b) the percentage of the recommended daily intake of the mineral nutrient, per serving of stated size, is 5% or more; and
(c) the mineral nutrient content is declared on the label or in the advertisement as a percentage of the daily value, per serving of stated size.
(2) If a statement or claim described in subsection (1) is made in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the percentage of the daily value, per serving of stated size, shall,
(a) in the case of an advertisement, other than a radio or television advertisement, be
(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and
(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;
(b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim; or
(c) in the case of a television advertisement, be communicated
(i) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions, or
(ii) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.
(3) The percentage of the daily value, per serving of stated size, that is communicated in the visual mode of a television advertisement in accordance with subparagraph (2)(c)(ii) shall
(a) appear concurrently with and for at least the same amount of time as the statement or claim;
(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and
(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.
(4) Subsection (1) does not apply to a statement or claim made in respect of the sodium or potassium content.
(5) Paragraphs (1)(a) and (c) do not apply in respect of a declaration of the total fluoride ion content as required by sections B.12.002 and B.12.008.
(6) Paragraph (1)(b) does not apply in respect of a declaration of the mineral nutrient content in a nutrition facts table.
(7) Paragraph (1)(c) does not apply in respect of a declaration of the chromium, copper, manganese, molybdenum and selenium content as required by subparagraph B.24.202(a)(v).
D.02.003 [Repealed, SOR/2003-11, s. 34]
D.02.004 No person shall, on the label of or in any advertisement for a food, make any claim concerning the action or effects of a mineral nutrient contained in the food, except to the effect that the mineral nutrient
(a) is a factor in the maintenance of good health; and
(b) is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development.
D.02.005 (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a mineral nutrient, no person shall, on the label of or in any advertisement for the prepackaged product, make a statement or claim concerning the mineral nutrient as a component of that ingredient unless
(a) despite subsection B.01.008(6), the mineral nutrient is declared by its common name immediately following the declaration of the ingredient in such a manner as to indicate that it is a component of that ingredient; and
(b) all components of the ingredient are declared.
(2) Paragraph (1)(b) does not apply to flour used as an ingredient in the manufacture of a prepackaged product referred to in subsection (1).
D.02.006 [Repealed, SOR/2003-11, s. 35]
D.02.007 [Repealed, SOR/88-559, s. 34]
D.02.008 No person shall, in advertising a food that is represented as containing a mineral nutrient or on a label of such food,
(a) give any assurance or guarantee of any kind with respect to the result that may be, has been or will be obtained by the addition of the mineral nutrient to a person’s diet; or
(b) refer to, reproduce or quote any testimonial.
D.02.009 No person shall sell a food to which any of the following mineral nutrients have been added unless a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than,
(a) in the case of calcium, 300 milligrams;
(b) in the case of phosphorus, 300 milligrams;
(c) in the case of iron, four milligrams; and
(d) in the case of iodine, 0.10 milligram.
D.02.010 (1) No person shall sell elemental iron powder for use in foods as a source of iron as a mineral nutrient unless
(a) subject to paragraph (b), the powder meets the specifications for
(i) Iron, Carbonyl,
(ii) Iron, Electrolytic, or
(iii) Iron, Reduced,
as set out in the Food Chemicals Codex, Third Edition, 1981, published by the National Academy of Sciences of the United States of America; and
(b) in the case of Iron, Reduced, 100 per cent by weight of the particles pass through a 100 mesh sieve and at least 95 per cent by weight of the particles pass through a 325 mesh sieve.
(2) No person shall sell a food to which elemental iron powder has been added as a source of iron as a mineral nutrient unless the powder meets the requirements referred to in paragraphs (1)(a) and (b).
D.02.011 No person shall sell a food to which sodium iron pyrophosphate has been added as a source of iron as a mineral nutrient unless
(a) the bioavailability of the iron in the food is not less than 50 per cent of the bioavailability of ferrous sulphate as determined by official method FO-42, Determination of Bioavailability of Iron, December 15, 1982; and
(b) that person retains documentary evidence showing that the bioavailability of the iron in the food has been determined by the official method referred to in paragraph (a) and, on request by the Director, submits such evidence to the Director.
TABLE I
Recommended Daily Intake
ItemColumn IColumn IIColumn IIIMineral NutrientUnitsIntake of persons 2 years of age or olderIntake of infants and children less than 2 years of age1Calcium(mg)11005002Phosphorus(mg)11005003Magnesium(mg)250554Iron(mg)1475Zinc(mg)946Iodide(µg)160557Selenium(µg)50158Copper(mg)20.59Manganese(mg)21.210Chromium(µg)1201211Molybdenum(µg)751512Chloride(mg)34001000TABLE II
Weighted Recommended Nutrient Intake
ItemColumn IColumn IIColumn IIIMineral NutrientUnitsAmount1Calciummilligrams7802Iodidemicrograms1553Ironmilligrams104Phosphorusmilligrams8855Magnesiummilligrams2106Zincmilligrams10DIVISION 3
Addition Of Vitamins, Mineral Nutrients Or Amino Acids To Foods
D.03.001 (1) In this Division, the expressions vitamin and mineral nutrient have the same meaning as in Divisions 1 and 2.
(2) This Division applies only in respect of foods that are represented as containing a vitamin, mineral nutrient or amino acid for use in human nutrition.
D.03.002 (1) Subject to section D.03.003, no person shall sell a food to which a vitamin, mineral nutrient or amino acid has been added unless the food is listed in Column I of the Table to this section and the vitamin, mineral nutrient or amino acid, as the case may be, is listed opposite that food in Column II of the Table.
(2) No milk or milk product or derivative listed in Column I of the Table to this section applies to the lacteal secretion obtained from the mammary gland of any animal other than a cow, genus Bos, or a product or derivative of such secretion unless that animal is identified therein.
TABLE
Column IColumn IIFoodVitamin, Mineral Nutrient or Amino Acid1Breakfast cerealsThiamine, niacin, vitamin B6, folic acid, pantothenic acid, magnesium, iron and zinc.2Fruit nectars, vegetable drinks, bases and mixes for vegetable drinks and a mixture of vegetable juicesVitamin C.2.1Fruit flavoured drinks that meet all the requirements of section B.11.150Vitamin C, folic acid, thiamine, iron, potassium.2.2Bases, concentrates and mixes that are used for making fruit flavoured drinks and that meet all the requirements of section B.11.151Vitamin C, folic acid, thiamine, iron, potassium.3Infant cereal productsThiamine, riboflavin, niacin or niacinamide, calcium, phosphorus, iron, iodine.4Margarine and other similar substitutes for butterVitamin A, Vitamin D, alpha-tocopherol5Alimentary pastesThiamine, riboflavin, niacin or niacinamide, folic acid, pantothenic acid, vitamin B6, iron, magnesium6Infant formulas and formulated liquid dietsAmino acids—alanine, arginine, aspartic acid, cystine, glutamic acid, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine;Minerals—calcium, chloride, chromium, copper, iodide, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc;Vitamins—alpha-tocopherol, biotin, d-pantothenic acid, folic acid, niacin, riboflavin, thiamin, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin K.6.1Foods represented for use in a very low energy dietVitamins—alpha-tocopherol, biotin, d-pantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin KMinerals—calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc7Flavoured beverage mixes and bases recommended for addition to milkVitamin A, thiamine, niacin or niacinamide, vitamin C, iron.8Simulated meat products, simulated poultry meat products, meat product extenders and poultry product extendersThiamine, riboflavin, niacin, pyridoxine, d-pantothenic acid, folic acid, vitamin B12, iron, magnesium, potassium, zinc, copper, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine.9Meal replacements and nutritional supplementsVitamins——alpha-tocopherol, biotin, d-pantothenic acid, folic acid, niacin, riboflavin, thiamine, vitamin A, vitamin B6, vitamin B12, vitamin C, vitamin DMinerals——calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium, zinc9.1Ready breakfast, instant breakfast and other similar breakfast replacement foods however describedVitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin C, iron10Condensed milk, milk, milk powder, sterilized milk, (naming the flavour) milkVitamin D.11Skim milk with added milk solids, partly skimmed milk with added milk solids, (naming the flavour) skim milk, (naming the flavour) partly skimmed milk, (naming the flavour) skim milk with added milk solids, (naming the flavour) partly skimmed milk with added milk solids, skim milk, partly skimmed milk, skim milk powderVitamin A, vitamin D.12Evaporated milkVitamin C, vitamin D.13Evaporated skim milk, concentrated skim milk, evaporated partly skimmed milk, concentrated partly skimmed milkVitamin A, vitamin C, vitamin D.14Apple juice, reconstituted apple juice, grape juice, reconstituted grape juice, pineapple juice, reconstituted pineapple juice, apple and (naming the fruit) juice as described in section B.11.132, concentrated fruit juice except frozen concentrated orange juiceVitamin C.15Flour, White Flour, Enriched Flour or Enriched White FlourThiamine, riboflavin, niacin, vitamin B6, folic acid, d-pantothenic acid, calcium, iron, magnesium.16[Repealed, SOR/94-689, s. 2]
17Table salt, table salt substitutesIodine.18Dehydrated potatoesVitamin C.19Products simulating whole eggVitamin A, thiamine, riboflavin, niacin or niacinamide, vitamin B6, d-pantothenic acid, folic acid, vitamin B12, alphatocopherol, calcium, iron, zinc, potassium.20[Repealed, SOR/90-830, s. 11]
21Goat’s milk, goat’s milk powderVitamin D22Partly skimmed goat’s milk, skimmed goat’s milk, partly skimmed goat’s milk powder, skimmed goat’s milk powderVitamins A and D23Evaporated goat’s milkVitamins C, D, folic acid24Evaporated partly skimmed goat’s milk, evaporated skimmed goat’s milkVitamins A, C, D, folic acid25Pre-cooked rice as defined in subsection B.13.010.1(1)Thiamine, niacin, vitamin B6, folic acid, pantothenic acid, iron26Mineral water, spring water, water in sealed containers, prepackaged iceFluorine27Liquid whole egg, dried whole egg, frozen whole egg, liquid yolk, dried yolk, frozen yolk, liquid egg white, (liquid albumen), dried egg white (dried albumen), frozen egg white (frozen albumen), liquid whole egg mix, dried whole egg mix, frozen whole egg mix, liquid yolk mix, dried yolk mix, frozen yolk mixVitamin A, Vitamin D, Vitamin E, thiamine, riboflavin, niacin, vitamin B6, folacin, vitamin B12, pantothenic acid, calcium, phosphorus, magnesium, potassium, iron, zincD.03.003 Section D.03.002 does not apply to a food when all of the following conditions are met:
(a) the food is
(i) a gluten-free food referred to in paragraph B.24.003(1)(g), or
(ii) represented for a special dietary use referred to in paragraph B.24.003(1)(h) or (i);
(b) no standard is prescribed in these Regulations for the food; and
(c) the food is not advertised.
[Repealed, SOR/2003-196, s. 105]
Division 4
DIVISION 5
Minerals In Drugs
D.05.001 to D.05.007 [Repealed, SOR/2003-196, s. 106]
D.05.008 (1) Subject to subsection (2), no person shall sell a drug containing fluorine if the largest recommended daily dosage of that drug as shown on the label thereof would, if consumed by a person, result in a daily intake by that person of more than one milligram of fluoride ion.
(2) Subsection (1) does not apply to a drug sold by prescription.
D.05.009 Where a drug contains fluorine, both the inner and outer labels of the drug shall carry a cautionary statement that, if the drug is used in an area where the drinking water has a natural fluorine content in excess of 0.7 parts of fluoride ion per million parts of water or is artificially fluoridated, mottling of the tooth enamel of a user of the drug may result.
D.05.010 [Repealed, SOR/2003-196, s. 107]
PART E
Cyclamate and Saccharin Sweeteners
E.01.001 (1) In this Part,
cyclamate sweetener
cyclamate sweetener means
(a) cyclohexyl sulfamic acid or a salt thereof, or
(b) any substance containing cyclohexyl sulfamic acid or a salt thereof
that is sold as a sweetener; (édulcorant au cyclamate)
saccharin sweetener
saccharin sweetener means
(a) saccharin or a salt thereof, or
(b) any substance containing saccharin or a salt thereof
that is sold as a sweetener. (édulcorant à la saccharine)
(2) Part B of these Regulations does not apply to any cyclamate sweetener or saccharin sweetener.
Sale
E.01.002 No person shall
(a) sell a cyclamate sweetener or saccharin sweetener that is not labelled as required by this Part; or
(b) commencing June 15, 1978, sell any saccharin sweetener to the general public except on the premises of a pharmacy.
Advertising
E.01.003 No person shall, in advertising to the general public a cyclamate sweetener or saccharin sweetener, make any representation other than with respect to the name, price and quantity of the sweetener.
Labelling
E.01.004 (1) Every cyclamate sweetener that is not also a saccharin sweetener shall be labelled to state that such sweetener should be used only on the advice of a physician.
(2) Commencing June 1, 1979, every saccharin sweetener shall be labelled to state that
(a) continued use of saccharin may be injurious to health; and
(b) it should not be used by pregnant women except on the advice of a physician.
E.01.005 Commencing June 1, 1979, every cyclamate sweetener or saccharin sweetener shall be labelled to show
(a) a list of all the ingredients and, in the case of
(i) cyclohexyl sulfamic acid,
(ii) a salt of cyclohexyl sulfamic acid,
(iii) saccharin,
(iv) a saccharin salt, or
(v) carbohydrates,
the quantity thereof contained in the sweetener; and
(b) the energy value of the sweetener expressed in calories
(i) per teaspoonful, drop, tablet or other measure used in the directions for use, and
(ii) per 100 grams or 100 millilitres
of the sweetener.
PART G
Controlled Drugs
Division 1
General
G.01.001 (1) In this Part,
agricultural implant
agricultural implant means a product that is presented in a form suitable to allow sustained release of an active ingredient over a certain period of time and that is intended for insertion under the skin of a food-producing animal for the purpose of increasing weight gain and improving feed efficiency; (implant agricole)
common name
common name with reference to a controlled drug means the name in English or French by which the controlled drug is commonly known; (nom usuel)
competent authority
competent authority means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of controlled drugs into or from the country; (autorité compétente)
controlled drug
controlled drug means a drug set out in the schedule to this Part and includes a preparation; (drogue contrôlée)
hospital
hospital means a facility
(a) that is licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness, or
(b) that is owned or operated by the Government of Canada or the government of a province and that provides health services; (hôpital)
international obligation
international obligation means an obligation in respect of a controlled drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres; (obligation internationale)
licence
licence[SOR/2004-238, s. 1]
licensed dealer
licensed dealer means the holder of a licence issued under section G.02.003.2; (distributeur autorisé)
parenteral use
parenteral use with reference to a controlled drug means administration by means of a hypodermic syringe, needle or other instrument through or into the skin of mucous membrane; (usage parentéral)
permit
permit means a permit issued under section G.02.008; (permis)
pharmacist
pharmacist
(a) means a person who is registered and entitled under the laws of a province
(i) to practise pharmacy, and
(ii) to operate a pharmacy or dispensary
and who is operating a pharmacy or dispensary and is practising pharmacy thereunder in that province, and
(b) includes, for the purposes of sections G.01.002, G.01.003, G.03.002 to G.03.008, G.03.014, G.03.015 and G.03.017 and subsections G.05.003(3) and (4), a person who is registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy in that province; (pharmacien)
practitioner
practitioner[Repealed, SOR/97-228, s. 7]
preparation
preparation means a drug that contains a controlled drug and one or more active medicinal ingredients, in a recognized therapeutic dose, other than a controlled drug; (préparation)
prescription
prescription means a direction given by a practitioner that a stated amount of a specified controlled drug be dispensed for the person named therein; (ordonnance)
proper name
proper name with reference to a controlled drug means the name in English or French
(a) assigned to the drug in section C.01.002,
(b) that appears in bold face type for the drug in the Regulations and where the drug is dispensed in a form other than that described in Part C, the name of the dispensing form, or
(c) assigned in any of the publications mentioned in Schedule B to the Food and Drugs Act in the case of a drug not included in paragraph (a) or (b) of this definition; (nom propre)
qualified person in charge
qualified person in charge means the individual with the qualifications specified in subsection G.02.001.2(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable)
test kit
test kit means an apparatus
(a) that contains reagent systems or buffering agents or both,
(b) that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes, and
(c) the contents of which are not intended for administration to humans; (nécessaire d’essai)
verbal order
verbal order means an order given orally. (commande verbale)
written order
written order[Repealed, SOR/85-550, s. 1]
(2) The definitions in this subsection apply in this Part and Part J.
Act
Act means the Controlled Drugs and Substances Act (Loi)
advertisement
advertisement has the same meaning as in section 2 of the Food and Drugs Act. (publicité ou annonce)
Department
Department has the same meaning as in section 2 of the Food and Drugs Act. (ministère)
designated criminal offence
designated criminal offence means
(a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code;
(b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code;
(c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code;
(d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or
(e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraphs (a) to (d). (infraction désignée en matière criminelle)
designated drug offence
designated drug offence means
(a) an offence against section 39, 44.2, 44.3, 48, 50.2 or 50.3 of the Food and Drugs Act, as those provisions read immediately before May 14, 1997,
(b) an offence against section 4, 5, 6, 19.1 or 19.2 of the Narcotic Control Act, as those provisions read immediately before May 14, 1997,
(c) an offence under Part I of the Controlled Drugs and Substances Act, except subsection 4(1), or
(d) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (c); (infraction désignée en matière de drogue)
label
label has the same meaning as in section 2 of the Food and Drugs Act. (étiquette)
package
package has the same meaning as in section 2 of the Food and Drugs Act. (emballage)
Security Directive
Security Directive means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department, as amended from time to time. (Directive en matière de sécurité)
(3) Unless otherwise provided, the definitions in subsection 2(1) of the Controlled Drugs and Substances Act apply in this Part and Part J.
G.01.002 (1) A person is authorized to have a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 or 17 of Part I of the schedule to this Part in his or her possession where the person has obtained the controlled drug under these Regulations, in the course of activities performed in connection with the enforcement or administration of an Act or regulation, or from a person who is exempt under section 56 of the Controlled Drugs and Substances Act from the application of subsection 5(1) of that Act with respect to that controlled drug, and the person
(a) requires the controlled drug for his business or profession and is
(i) a licensed dealer,
(ii) a pharmacist, or
(iii) a practitioner who is registered and entitled to practise in the province in which he has such possession;
(b) is a practitioner who is registered and entitled to practise in a province other than the province in which he has such possession and such possession is for emergency medical purposes only;
(c) is a hospital employee or a practitioner in a hospital;
(d) has obtained the controlled drug for his own use from a practitioner or pursuant to a prescription that is not issued or obtained in contravention of these Regulations;
(e) is a practitioner of medicine who received the controlled drug under subsection G.06.001(3) or (4) and whose possession is for a purpose referred to in subsection G.06.001(5);
(f) is an agent of a practitioner of medicine who received the controlled drug under subsection G.06.001(3) and whose possession is for the purpose of complying with subsection G.06.001(4);
(g) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, peace officer or member of the technical or scientific staff of any department of the Government of Canada or of a province or university and such possession is for the purposes of and in connection with such employment;
(h) is a person other than a person referred to in paragraph (e) or (f), is exempted under section 56 of the Controlled Drugs and Substances Act with respect to possession of that controlled drug and whose possession is for a purpose set out in the exemption; or
(i) is a person referred to in paragraph G.06.001(5)(b).
(2) A person is authorized to have a controlled drug referred to in subsection (1) in his possession where the person is acting as the agent for any person referred to in paragraph (1)(a) to (e), (h) or (i).
(3) A person is authorized to have a controlled drug referred to in subsection (1) in his possession where
(a) the person is acting as the agent for a person he has reasonable grounds to believe is a person referred to in paragraph (1)(g); and
(b) the possession of the controlled drug is for the purpose of assisting that person in the enforcement or administration of an Act or a regulation.
G.01.002.1 Section C.01.004 does not apply to a test kit that contains a controlled drug where a registration number has been issued for the test kit pursuant to section G.06.002.3 and has not been cancelled pursuant to section G.06.002.4.
G.01.003 In the case of a controlled drug that is dispensed by a pharmacist pursuant to a prescription, section C.01.004 does not apply but the label of the package in which the controlled drug is contained shall carry the following:
(a) the name and address of the pharmacy or pharmacist;
(b) the date and number of the prescription;
(c) the name of the person for whom the controlled drug is dispensed;
(d) the name of the practitioner;
(e) directions for use; and
(f) any other information that the prescription requires be shown on the label.
G.01.004 The Controlled Drugs and Substances Act and this Part do not apply in respect of a controlled drug that is contained in an agricultural implant and set out in Part III of the schedule to this Part, but nothing in this section exempts such a drug from the requirements of Part C.
G.01.005 [Repealed, SOR/80-543, s. 12]
G.01.006 Except as otherwise provided in this Part, no person shall sell a controlled drug or preparation that does not comply with all provisions of Parts C and D applicable to it.
G.01.007 No person shall
(a) advertise a controlled drug to the general public; or
(b) issue or publish any other written advertisement respecting a controlled drug unless that advertisement carries the symbol in a clear and conspicuous colour and size in the upper left quarter of the first page of the advertisement.
G.01.008 [Repealed, SOR/80-543, s. 12]
Prescribed Manner of Notice of Application for an Order of Restoration
G.01.010 (1) For the purpose of subsection 24(1) of the Controlled Drugs and Substances Act, notice of application for an order of restoration shall be given in writing to the Attorney General by registered mail.
(2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application for an order of restoration is to be made to the magistrate and shall specify
(a) the magistrate to whom the application is to be made;
(b) the time and place where the application is to be heard;
(c) the controlled drug or other thing in respect of which the application is to be made; and
(d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the controlled drug or other thing referred to in paragraph (c).
DIVISION 2
Licences And Licensed Dealers
G.02.001 Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a controlled drug.
G.02.001.1 To be eligible for a dealer’s licence, a person must be
(a) an individual who ordinarily resides in Canada;
(b) a corporation that has its head office in Canada or operates a branch office in Canada; or
(c) the holder of a position that includes responsibility for controlled drugs on behalf of a department of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.
G.02.001.2 (1) A licensed dealer
(a) shall designate no more than one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to controlled drugs specified in the licence and for ensuring on behalf of the licensed dealer that those activities comply with these Regulations; and
(b) may designate an alternate qualified person in charge who must work at the premises specified the licence and have authority to replace the qualified person in charge when that person is absent.
(2) The qualified person in charge and, if applicable, the alternate qualified person in charge
(a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;
(b) shall be a pharmacist or a practitioner registered with a licensing body of a province or possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and
(c) shall not have been convicted, as an adult, within the preceding 10 years, of
(i) a designated drug offence,
(ii) a designated criminal offence, or
(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).
G.02.002 No licensed dealer may import or export a controlled drug without a permit.
G.02.002.1 A licensed dealer is authorized to have a controlled drug in his possession for the purpose of exporting the controlled drug from Canada if he has obtained the controlled drug pursuant to these Regulations.
G.02.003 (1) To apply for a dealer’s licence, a person shall submit an application to the Minister containing
(a) if the licence is sought for
(i) an individual, the individual’s name,
(ii) a corporation, the corporation’s name and any other name registered with a province, under which it intends to carry out the activities specified in its dealer’s licence or intends to identify itself; and
(iii) the holder of a position mentioned in paragraph G.02.001.1(c), the applicant’s name and the title of the position;
(b) the address, telephone number and, if applicable, the facsimile number and e-mail address for the premises to which the dealer’s licence would apply and, if different, the mailing address for the premises;
(c) the name, date of birth and gender of the individual in charge of the premises;
(d) with respect to the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises,
(i) their name, date of birth and gender,
(ii) their academic qualifications, training and work experience relevant to their duties,
(iii) their hours of work at the premises,
(iv) their title at the premises,
(v) the name and title of their immediate supervisor at the premises, and
(vi) in the case of a pharmacist or a practitioner, the name of the province in which the person’s current professional licence, certification or authorization was issued and the professional licence, certification or authorization number;
(e) the name and gender of the individuals authorized to place an order for a controlled drug on behalf of the applicant;
(f) in the case of a product or compound that contains a controlled drug but is not a test kit and that would be made or assembled for or by the applicant, a list that sets out
(i) the brand name, if any, of each product or compound,
(ii) the controlled drug in each product or compound,
(iii) the strength per unit of the controlled drug in each product or compound,
(iv) the quantity or package sizes of each product or compound, and
(v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and the dealer’s licence number of the other dealer;
(g) the activities referred to in section G.02.001 for which the licence is sought that would be carried out at the premises to which the dealer’s licence would apply;
(h) if the licence is sought to produce a controlled drug other than a product or compound that contains a controlled drug,
(i) the name of the controlled drug to be produced,
(ii) the quantity that the applicant expects to produce under the dealer’s licence and the period during which that quantity would be produced, and
(iii) if the controlled drug would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of the other dealer;
(i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive;
(j) a detailed description of the method that the applicant proposes to use for recording their controlled drug transactions; and
(k) for any activity referred to in section G.02.001, other than the activities described in paragraphs (f) and (h), the controlled drug and the purpose for carrying out the activity.
(2) An application for a dealer’s licence must
(a) be signed by the individual in charge of the premises to which the licence would apply; and
(b) be accompanied by a statement signed by the individual in charge indicating that
(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii) the individual has the authority to bind the applicant.
(3) An application for a dealer’s licence must be accompanied by
(a) declarations signed by the individual in charge of the premises, the qualified person in charge and, if applicable, the alternate qualified person in charge, stating that they have not been convicted, as an adult, during the preceding 10 years of
(i) a designated drug offence,
(ii) a designated criminal offence, or
(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);
(b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the preceding 10 years, of a designated drug offence or a designated criminal offence;
(c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada;
(d) a statement, signed and dated by the individual in charge of the premises to which the application applies, stating that the qualified person in charge and, if applicable, the alternate qualified person in charge have the knowledge and experience required under paragraph G.02.001.2(2)(a);
(e) if the qualified person in charge or, if applicable, the alternate qualified person in charge is not a pharmacist or a practitioner registered with a licensing body of a province, a copy of the person’s degree required under paragraph G.02.001.2(2)(b) and a copy of the course transcript for that degree;
(f) if the applicant’s name appears on the label of a product or compound that contains a controlled drug, a copy of the inner label, as defined in section A.01.010, for each product or compound to which the licence would apply; and
(g) if the applicant is a corporation, a copy of
(i) the certificate of incorporation or other constituting instrument, and
(ii) any document filed with the province in which the premises to which the licence would apply are located that states its corporate name or any other name registered with the province, under which the applicant intends to carry out the activities specified in its dealer’s licence or intends to identify itself.
(4) The method proposed by the applicant under paragraph (1)(j) must
(a) allow for the recording of controlled drug transactions in accordance with section G.02.014; and
(b) permit the Minister to audit the activities of the licensed dealer with respect to controlled drugs.
(5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing
(a) to having a criminal record check carried out for them, as an adult, in respect of the offences referred to in those paragraphs during the preceding 10 years;
(b) to provide all necessary information and to submit to any means of identification required to obtain the criminal record check; and
(c) to pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations.
G.02.003.1 The Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application.
G.02.003.2 Subject to section G.02.003.3, the Minister shall, after examining the information and documents required under sections G.02.003 and G.02.003.1, issue a dealer’s licence that contains
(a) the licence number;
(b) the name of the applicant or the title of the position they hold, as the case may be, or, if the applicant is a corporation, its corporate name;
(c) a list of the activities that are permitted;
(d) the address of the premises at which the licensed dealer may carry on the permitted activities;
(e) the name of the controlled drug for which the activities are permitted;
(f) the security level at the premises;
(g) the effective date of the licence;
(h) the expiry date of the licence, which may not be later than three years after its effective date;
(i) any conditions to be met by the holder of the licence to
(i) ensure that an international obligation is respected,
(ii) provide the security level referred to in paragraph (f), or
(iii) reduce the potential security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use;
(j) in the case of a producer of a controlled drug, the quantity of the controlled drug that may be produced under the licence and the period during which that quantity may be produced; and
(k) in the case of the maker or assembler of a product or compound that contains a controlled drug but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:
(i) the licence number,
(ii) the brand name, if any, of each product or compound,
(iii) the controlled drug in each product or compound,
(iv) the strength per unit of the controlled drug in each product or compound, and
(v) the quantity or package sizes of each product or compound.
G.02.003.3 (1) The Minister shall refuse to issue, renew or amend a dealer’s licence if
(a) the applicant is not an eligible person under section G.02.001.1;
(b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section G.02.015;
(c) false or misleading information or false or falsified documents were submitted in or with the application;
(d) an activity for which the licence is requested would not be in compliance with an international obligation;
(e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation;
(f) the applicant does not have in place the security measures set out in the Security Directive in respect of an activity for which the licence is requested;
(g) the applicant is in contravention of or has contravened during the preceding 10 years
(i) a provision of the Act or the regulations made or continued under it, or
(ii) a term or condition of another dealer’s licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act;
(h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a controlled drug being diverted to an illicit market or use;
(i) the individual in charge of the premises, the qualified person in charge or, if applicable, the alternate qualified person in charge has been convicted, as an adult, within the previous 10 years, of
(i) a designated drug offence,
(ii) a designated criminal offence, or
(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);
(j) the proposed method referred to in paragraph G.02.003(1)(j) is not capable of recording controlled drug transactions as required under section G.02.014 or permitting the Minister to audit the applicant’s activities with respect to controlled drugs in a timely manner; or
(k) the additional information required under section G.02.003.1 has not been provided or is insufficient to process the application.
(2) The Minister is not required to refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant
(a) does not have a history of non compliance with the Act or any regulation made or continued under it; and
(b) has carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations.
G.02.003.4 (1) To apply to renew a dealer’s licence, a licensed dealer shall submit to the Minister
(a) the information referred to in paragraphs G.02.003(1)(a) to (k); and
(b) the following documents, namely,
(i) the documents referred to in paragraphs G.02.003(3)(a) and (d) and, subject to subsection G.02.003(5), the document referred to in paragraph G.02.003(3)(b),
(ii) if applicable and if not previously submitted in respect of the dealer’s licence that is being renewed, the document referred to in paragraph G.02.003(3)(e), and
(iii) the original dealer’s licence that is to be renewed.
(2) An application for renewal must
(a) be signed by the individual in charge of the premises to which the renewed dealer’s licence would apply; and
(b) be accompanied by a statement signed by the individual in charge indicating that
(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii) the individual in charge has the authority to bind the applicant.
(3) Subject to section G.02.003.3, the Minister shall, after examining the information and documents required under subsections (1) and (2) and section G.02.003.1, issue a renewed dealer’s licence that contains the information specified in paragraphs G.02.003.2(a) to (k).
G.02.003.5 (1) To have its dealer’s licence amended, a licensed dealer shall submit to the Minister
(a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section G.02.003 that are relevant to the proposed amendment; and
(b) the original dealer’s licence.
(2) An application for amendment must
(a) be signed by the individual in charge of the premises to which the amended dealer’s licence would apply; and
(b) be accompanied by a statement signed by the individual in charge indicating that
(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii) the individual in charge has the authority to bind the applicant.
(3) Subject to section G.02.003.3, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer’s licence in accordance with the application and may add any conditions to be met by the holder of the licence to
(a) ensure that an international obligation is respected;
(b) provide for the security level referred to in paragraph G.02.003.2(f) or the new level required as a result of the amendment being implemented; or
(c) reduce the potential security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use.
G.02.003.6 (1) A licensed dealer shall
(a) obtain the Minister’s approval before making any of the following changes, namely,
(i) a change relating to the security at the premises referred to in the dealer’s licence, or
(ii) the replacement or addition of
(A) the individual in charge of the premises to which the dealer’s licence applies,
(B) the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises to which the dealer’s licence applies, and
(C) an individual authorized to place an order for a controlled drug on behalf of the licensed dealer;
(b) notify the Minister, not later than 10 days after the change, when a person referred to in clause (a)(ii)(A) or (C) ceases to carry out their duties as specified in
(i) the application for the dealer’s licence under section G.02.003,
(ii) the application to renew the dealer’s licence under section G.02.003.4, or
(iii) the request for approval under paragraph (a); and
(c) notify the Minister, not later than the next business day after the change, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as specified in
(i) the application for the dealer’s licence under section G.02.003,
(ii) the application to renew the dealer’s licence under section G.02.003.4, or
(iii) the request for approval under paragraph (a).
(2) The licensed dealer shall, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person:
(a) in the case of the replacement of the individual in charge of the premises to which the dealer’s licence applies,
(i) the information specified in paragraph G.02.003(1)(c), and
(ii) the declarations specified in paragraph G.02.003(3)(a) and, subject to subsection G.02.003(5), the documents specified in paragraphs G.02.003(3)(b) and (c);
(b) in the case of the replacement of the qualified person in charge or the replacement or addition of the alternate qualified person in charge at the premises to which the dealer’s licence applies,
(i) the information specified in paragraph G.02.003(1)(d), and
(ii) the documents specified in paragraphs G.02.003(3)(a), (d) and (e) and, subject to section G.02.003(5), the documents specified in paragraphs G.02.003(3)(b) and (c); and
(c) in the case of the replacement or addition of an individual who is authorized to place an order for a controlled drug on behalf of the licensed dealer, the individual’s name and gender.
G.02.003.7 The Minister shall revoke a dealer’s licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen.
G.02.003.8 (1) Subject to subsection (2), the Minister shall revoke a dealer’s licence in accordance with section G.02.003.91 if
(a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application;
(b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under this Part;
(c) the licensed dealer is no longer an eligible person under section G.02.001.1;
(d) it is discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises, has been convicted, as an adult, within the preceding 10 years, of
(i) a designated drug offence,
(ii) a designated criminal offence, or
(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or
(e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use.
(2) The Minister is not required to revoke a dealer’s licence under paragraph (1)(a) or (b) if the licensed dealer
(a) has no history of non-compliance with the Act and the regulations made or continued under it; and
(b) has carried out, or signed an undertaking to carry out, corrective measures to ensure compliance with the Act and these Regulations.
G.02.003.9 The Minister shall suspend a dealer’s licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a controlled drug from being diverted to an illicit market or use.
G.02.003.91 (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer’s licence under this Part, the Minister shall
(a) send a notice to the applicant or to the holder of the licence, together with a written report that sets out the reasons for the proposed refusal or revocation; and
(b) give the applicant or holder an opportunity to be heard in respect of the proposed refusal or revocation.
(2) The suspension of a dealer’s licence under this Part takes effect as soon as the Minister notifies the holder of the licence of the decision to suspend and provides a written report that sets out the reasons for the suspension.
(3) A person who receives a notice of suspension referred to in subsection (2) may, within 10 days after receiving the notice, provide the Minister with reasons why the suspension of the licence is unfounded.
G.02.004 A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only the controlled drugs specified in their dealer’s licence.
G.02.005 to G.02.007 [Repealed, SOR/2004-238, s. 4]
G.02.008 The Minister may, upon application therefor, issue a permit to any licensed dealer for the importation or exportation of a controlled drug.
G.02.009 An application for a permit shall be in a form approved by the Minister.
G.02.010 Every licence or permit issued under this Part is subject to the condition that the licensed dealer will comply with the provisions of this Part.
G.02.011 The Minister shall revoke or suspend a permit issued under this Part if the Minister determines that the person to whom the permit was issued has failed to comply with any term or condition of the permit or any provision of these Regulations.
G.02.012 A dealer’s licence is valid until the earlier of
(a) the expiry date set out in the licence, and
(b) the revocation or suspension of the licence under section G.02.003.7, G.02.003.8 or G.02.003.9.
G.02.013 A permit issued under section G.02.008 is valid only for the particular importation or exportation in respect of which it was issued.
G.02.014 (1) Every licensed dealer shall keep a record of the following:
(a) the name and quantity of any controlled drug received by the licensed dealer, the name and address of the person who sold or provided it and the date it was received;
(b) the name, quantity and form of any controlled drug sold or provided by the licensed dealer, the name and address of the person to whom it was sold or provided and the date it was sold or provided;
(c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that narcotic, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;
(c.1) the name and quantity of any narcotic produced and the date on which it was placed in stock; and
(d) the name and quantity of any controlled drug he had in stock at the end of each month.
(2) The record of information referred to in subsection (1) shall be kept
(a) in a manner that permits an audit to be made;
(b) subject to subsection (3), in a book, register or similar record maintained exclusively for controlled drugs; and
(c) for any period of at least two years on the premises described in the licence of the licensed dealer.
(3) The record of information referred to in paragraphs (1)(a), (b) and (d) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b).
G.02.015 (1) The Minister may, in respect of an applicant for a dealer’s licence or a licensed dealer, require an inspection, at any reasonable time, of
(a) the premises used or intended to be used in producing, making, assembling or storing a controlled drug; and
(b) the process and conditions of the producing, making, assembling or storing.
(2) The Minister may, in respect of a licensed dealer, require a verification to be made, at any reasonable time, of the qualifications of its technical staff concerned with producing, making, assembling or storing a controlled drug.
G.02.016 Every licensed dealer shall
(a) furnish such information respecting the dealings of such person in any controlled drug in such form and at such times as the Minister may require;
(b) produce to an inspector any books, records or documents required to be kept by this Part;
(c) permit an inspector to make copies of or to take extracts from such books, records and documents; and
(d) permit an inspector to check all stock of controlled drugs located on the premises described in the licence of the licensed dealer.
G.02.017 [Repealed, SOR/78-427, s. 3]
G.02.018 Every licensed dealer shall notify the Minister promptly of changes in the following:
(a) his technical staff;
(b) the premises in which a controlled drug is produced, made, assembled or stored; and
(c) the process and conditions of the producing, making, assembling or storing.
G.02.019 Every licensed dealer shall
(a) provide such protection against loss or theft of any controlled drug in his possession as may be required by the Minister;
(b) report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof; and
(c) securely pack a controlled drug in its immediate container and seal it in such a manner that it cannot be opened without breaking the seal.
G.02.020 A licensed dealer may only import into or export out of Canada a controlled drug at the place specified in his permit.
G.02.021 A licensed dealer shall securely pack in a package sealed in such a manner that it cannot be opened without breaking the seal any controlled drug intended for export out of Canada.
G.02.022 A licensed dealer shall in taking delivery of a controlled drug imported by him or in making delivery of a controlled drug
(a) take such steps as are necessary to ensure the safekeeping of the drug during transit; and
(b) use such method of transportation as will ensure an accurate record being kept of the drug and of the signatures of any persons having charge of the drug until it is delivered to the consignee.
G.02.023 Notwithstanding section G.02.022, a preparation may be delivered by common carrier.
G.02.024 A licensed dealer shall not sell or provide a controlled drug to any person other than a
(a) licensed dealer;
(b) pharmacist;
(c) practitioner;
(d) hospital employee or a practitioner in a hospital;
(e) Regional Director of the Department; or
(f) a person who has been granted an exemption under section 56 of the Controlled Drugs and Substances Act with respect to the possession of a controlled drug.
G.02.024.1 Subject to section G.02.024.2 and notwithstanding sections G.02.024 and G.02.025, no licensed dealer shall
(a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2;
(b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2;
(c) sell or provide a controlled drug, other than a preparation, to a practitioner named in a notice given by the Minister under section G.04.004.2; or
(d) sell or provide a preparation to a practitioner named in a notice given by the Minister under section G.04.004.2.
G.02.024.2 Section G.02.024.1 does not apply to a licensed dealer to whom the Minister has issued a notice of retraction of the notice
(a) under section G.03.017.3, in respect of a pharmacist named in a notice issued by the Minister under section G.03.017.2; or
(b) under section G.04.004.3, in respect of a practitioner named in a notice issued by the Minister under section G.04.004.2.
G.02.025 (1) Subject to this section, a licensed dealer may, in accordance with the terms and conditions of their dealer’s licence, sell or provide a controlled drug to a person referred to in section G.02.024 if
(a) the drug is contained in a package that is authorized and described in the dealer’s licence of the producer, maker or assembler of the drug; and
(b) the licensed dealer has received, on the premises described in the licence,
(i) a written order,
(ii) an order sent through a computer from a remote input device, or
(iii) a verbal order for a controlled drug listed in Part II or III of the schedule to this Part
that specifies the name and quantity of the drug to be supplied.
(2) A licensed dealer who has received an order referred to in subparagraph (1)(b)(i) and verified the signature on the order may sell or provide a controlled drug to a person referred to in section G.02.024, if the order is signed and dated by one of the following persons:
(a) if the controlled drug is to be sold or provided to a person referred to in paragraph G.02.024(2)(a), (b), (c), (e) or (f), by that person; or
(b) if the controlled drug is to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order.
(3) A licensed dealer may sell or provide a controlled drug pursuant to an order received from a remote input device through a computer if the computer program and the remote input device meet the requirements of subsections (5) and (6).
(3.1) A licensed dealer who has received an order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii) may provide a controlled drug to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order.
(3.2) A licensed dealer who has received a verbal order referred to in subparagraph (1)(b)(iii) may provide a controlled drug listed in Part II or III of the schedule to this Part to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order.
(4) A licensed dealer who has received a verbal order referred to in subparagraph (1)(b)(iii), and has provided a controlled drug listed in Part II or III of the schedule to this Part to a person referred to in paragraphs G.02.024(b) to (d), shall immediately record
(a) the name of the person to whom the controlled drug was sold or provided;
(b) if the drug was provided to a hospital employee or a practitioner in a hospital, the name of the pharmacist in charge of the dispensary of the hospital or the name of the practitioner authorized by the person in charge of the hospital to sign the order; and
(c) the date that the order is received.
(5) For the purposes of this section, a remote input device shall be a device for transmitting electronically orders for drugs, other than by voice communication, that
(a) contains a unique identifying code that can be related to the device and the pharmacist or practitioner in whose possession and care the remote input device has been placed;
(b) is in the possession and care of that pharmacist or practitioner; and
(c) is designed in such a way that the unique identifying code for the remote input device is an integral part of the circuitry and can only be modified by the dismantling of the device.
(6) For the purposes of this section, a computer program shall be able to
(a) identify the remote input device, the name and address of the pharmacist or practitioner in whose possession and care the remote input device has been placed;
(b) identify the pharmacist or practitioner placing the order by means of an identifying code unique to that pharmacist or practitioner;
(c) process separately and identify controlled drugs by the segregation of the orders for those drugs;
(d) detect unusual orders and thereby necessitate manual intervention by the licensed dealer; and
(e) necessitate manual intervention by the licensed dealer if one or more of the check procedures fails.
(7) Where a licensed dealer has received, from a pharmacist or practitioner, an order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii) or a verbal order referred to in subparagraph (1)(b)(iii), he shall, within five working days of filling the order for a controlled drug, obtain and keep a receipt that includes
(a) the signature of the pharmacist or the practitioner who received the controlled drug;
(b) the date the pharmacist or practitioner received the controlled drug; and
(c) the name and the quantity of the controlled drug.
(8) If a licensed dealer has not received a receipt from a pharmacist or practitioner under subsection (7) within the time prescribed by that subsection, the dealer shall not, until after receiving the receipt, sell or provide a controlled drug to the pharmacist or practitioner pursuant to a further
(a) order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii); or
(b) verbal order referred to in subparagraph (1)(b)(iii).
from that pharmacist or practitioner.
G.02.026 A licensed dealer shall not sell or provide a controlled drug more than once in respect of one order unless
(a) the order for the drug states that the quantity of the drug is to be sold or provided
(i) in specified portions,
(ii) in separate deliveries not exceeding four deliveries, and
(iii) at specified intervals; or
(b) at the time of receipt of the order the licensed dealer temporarily does not have in stock the quantity of the drug ordered, in which case the dealer may sell or provide against the order the quantity of the drug that the dealer has available and deliver the balance later in accordance with the order.
G.02.027 [Repealed, SOR/80-543, s. 12]
DIVISION 3
Pharmacists
G.03.001 (1) A pharmacist, on receipt of a controlled drug from a licensed dealer, shall keep a record of the name and quantity of the controlled drug received by them, the name and address of the person who sold or provided it and the date it was received.
(2) The record of information referred to in subsection (1) shall be kept
(a) in a manner that permits an audit to be made; and
(b) subject to subsection (3), in a book, register or similar record maintained exclusively for controlled drugs.
(3) The record of information referred to in subsection (1) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b).
G.03.002 No pharmacist shall, except as otherwise provided in this Part, sell or provide a controlled drug to any person unless the pharmacist has first been provided with a prescription for it, and
(a) if the prescription is in writing, it has been signed and dated by the practitioner issuing the same and the signature of the practitioner where not known to the pharmacist, has been verified by him; or
(b) if the prescription is given verbally, the pharmacist has taken reasonable precaution to satisfy himself that the person giving the prescription is a practitioner.
G.03.002.1 Subject to section G.03.002.2 and notwithstanding sections G.03.002, G.03.003 and G.03.005, no pharmacist shall
(a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2;
(b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2;
(c) dispense, sell or provide a controlled drug, other than a preparation, to, or pursuant to a prescription or order given by, a practitioner named in a notice given by the Minister under section G.04.004.2; or
(d) dispense, sell or provide a preparation to a practitioner or pursuant to a prescription or order given by a practitioner named in a notice given by the Minister under section G.04.004.2.
G.03.002.2 Section G.03.002.1 does not apply to a pharmacist to whom the Minister has issued a notice of retraction of the notice
(a) under section G.03.017.3, in respect of a pharmacist named in a notice issued by the Minister under section G.03.017.2; or
(b) under section G.04.004.3, in respect of a practitioner named in a notice issued by the Minister under section G.04.004.2.
G.03.003 A pharmacist may sell or provide a controlled drug to a practitioner for use in their practice
(a) upon a written order, signed and dated by that practitioner, that has been verified if the signature of the practitioner is unknown to the pharmacist; or
(b) upon a verbal order specifying the name and quantity of the drug if the pharmacist has taken reasonable precautions to satisfy themself that the person making the order is a practitioner.
G.03.004 A pharmacist shall, in respect of controlled drugs sold or provided to a practitioner under section G.03.003, keep in a special prescription file a record showing the date, the name and address of the practitioner, and the quantity and kind of controlled drug sold or provided.
G.03.005 A pharmacist may provide a controlled drug to a hospital employee or to a practitioner in a hospital on receipt of a written order signed and dated by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order, if the signature of that pharmacist or practitioner is known to the pharmacist or, if unknown, has been verified.
G.03.006 A pharmacist shall not refill a prescription for a controlled drug unless
(a) the practitioner, at the time that he issued the prescription, directed in writing, in the case of a controlled drug listed in Part I of the schedule to this Part, or directed in writing or orally, in the case of a controlled drug listed in Part II or III of the schedule to this Part, that the prescription be refilled, the number of times that it may be refilled and the dates for or the intervals between refills; and
(b) the pharmacist keeps a record of each refilling of a prescription.
G.03.007 A pharmacist who dispenses, pursuant to an order or prescription, a controlled drug listed in Part I of the schedule to this Part, other than a preparation, shall forthwith enter in a book, register or similar record maintained for such purposes
(a) the name and address of the person named in the order or prescription;
(b) the name, initials and address of the practitioner who issued the order or prescription;
(c) the name or initials of the pharmacist who dispensed the controlled drug;
(d) the name, quantity and form of the controlled drug dispensed;
(e) the date on which the controlled drug was sold or provided; and
(f) the number assigned to the order or prescription.
G.03.008 A pharmacist shall, before dispensing a controlled drug pursuant to a prescription given orally or a verbal order, make a written record thereof, setting forth,
(a) the name and address of the person named in the prescription;
(b) the name, quantity and form of such controlled drug;
(c) the directions for use given therewith;
(d) the name, initials and address of the practitioner who issued the prescription;
(e) the name or initials of the pharmacist who dispensed such controlled drug;
(f) the date on which the controlled drug was sold or provided; and
(g) the number assigned to the prescription.
G.03.009 A pharmacist shall maintain a special prescription file in which shall be filed in sequence as to date and number all written orders or prescriptions in writing for controlled drugs dispensed and the written record of all controlled drugs dispensed pursuant to a prescription or order verbally given.
G.03.010 A pharmacist shall retain in his possession for a period of at least two years, any records which he is required to keep by this Part.
G.03.011 A pharmacist shall
(a) furnish such information respecting the dealings of the pharmacist in any controlled drug in such form and at such times as the Minister may require;
(b) make available and produce to an inspector upon request his special prescription file together with any books, records or documents which he is required to keep;
(c) permit an inspector to make copies of or to take extracts from such files, books, records or documents; and
(d) permit an inspector to check all stocks of controlled drugs on his premises.
G.03.012 A pharmacist shall take all reasonable steps that are necessary to protect controlled drugs on his premises or under his control against loss or theft.
G.03.013 A pharmacist shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.
G.03.014 A pharmacist may, upon receiving a written order for a controlled drug signed and dated by
(a) the licensed dealer who sold or provided that drug to them, return that drug to that dealer;
(b) another pharmacist, sell or provide any quantity of that drug to that other pharmacist that is specified in the order as being required for emergency purposes;
(c) a Regional Director of the Department, sell or provide to or in accordance with the order of that Director any quantity of that drug, specified in the order, that is required by the Director in connection with their duties; and
(d) a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to that controlled drug, sell or provide to that person any quantity of that drug that is specified in the order.
G.03.015 A pharmacist shall immediately after receiving, selling or providing a controlled drug under paragraph G.03.014(b) or (c) or subsection G.05.003(4) enter the details of the transaction in a book, register or other record maintained for the purpose of recording such transactions.
G.03.016 A pharmacist shall forthwith after removing, transporting or transferring a controlled drug from his place of business to any other place of business operated by him notify the Minister, setting out the details.
G.03.017 The Minister shall provide in writing any factual information about a pharmacist that has been obtained under the Act or these Regulations to the licensing authority responsible for the registration or authorization of the person to practise their profession
(a) in the province in which the pharmacist is registered or entitled to practise if
(i) the authority submits a written request that states the name and address of the pharmacist, a description of the information being sought and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or
(ii) the Minister has reasonable grounds to believe that the pharmacist has
(A) contravened a rule of conduct established by the authority,
(B) been found guilty in a court of law of a designated drug offence or of a contravention of this Part, or
(C) contravened a provision of this Part; or
(b) in a province in which the pharmacist is not registered or entitled to practise, if the authority submits to the Minister
(i) a written request for information that states
(A) the name and address of the pharmacist, and
(B) a description of the information being sought, and
(ii) documentation that shows that the pharmacist has applied to that authority to practise in that province.
G.03.017.1 A pharmacist may make a written request to the Minister to send to the persons and authorities specified in subsection G.03.017.2(3) a notice, issued under section G.03.017.2, advising them that recipients of the notice must not sell or provide a controlled drug other than a preparation, a preparation, or both, to that pharmacist.
G.03.017.2 (1) In the circumstances described in subsection (2), the Minister must issue a notice to the persons and authorities specified in subsection (3) advising them that licensed dealers and pharmacists practising in the notified pharmacies must not sell or provide to the pharmacist named in the notice a controlled drug other than a preparation, a preparation, or both.
(2) The notice must be issued if the pharmacist named in the notice has
(a) made a request to the Minister in accordance with section G.03.017.1 to issue the notice;
(b) contravened a rule of conduct established by the licensing authority of the province in which the pharmacist is practising and that licensing authority has requested the Minister in writing to issue the notice; or
(c) been found guilty in a court of law of a designated drug offence or of an offence under this Part.
(3) The notice must be issued to
(a) all licensed dealers;
(b) all pharmacies within the province in which the pharmacist named in the notice is registered and practising;
(c) the licensing authority of the province in which the pharmacist named in the notice is registered or entitled to practise; and
(d) any interested licensing authority in another province that has made a request to the Minister to issue the notice.
(4) Subject to subsection (5), the Minister may issue the notice described in subsection (1) to the persons and authorities specified in subsection (3), if the Minister, on reasonable grounds, believes that the pharmacist named in the notice
(a) has contravened any of the provisions of sections G.03.001 to G.03.016;
(b) has, on more than one occasion, self-administered a controlled drug, other than a preparation, contrary to accepted pharmaceutical practice;
(c) has, on more than one occasion, self-administered a preparation, contrary to accepted pharmaceutical practice;
(d) has, on more than one occasion, provided or administered a controlled drug, other than a preparation, to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice;
(e) has, on more than one occasion, provided or administered a preparation to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice; or
(f) is unable to account for the quantity of controlled drug for which the pharmacist was responsible under this Part.
(5) In the circumstances described in subsection (4), the Minister must not issue the notice referred to in subsection (1) until the Minister has
(a) consulted with the licensing authority of the province in which the pharmacist to whom the notice relates is registered or entitled to practise;
(b) given that pharmacist an opportunity to present reasons why the notice should not be issued and considered those reasons; and
(c) considered
(i) the compliance history of the pharmacist in respect of the Act and the regulations made or continued under it, and
(ii) whether the actions of the pharmacist pose a significant security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use.
G.03.017.3 The Minister must provide the licensed dealers, pharmacies and licensing authorities who were issued a notice under subsection G.03.017.2(1) with a retraction of that notice if
(a) in the circumstance described in paragraph G.03.017.2(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was issued by the Minister; or
(b) in a circumstance described in any of paragraphs G.03.017.2(2)(b) and (c) and (4)(a) to (f), the pharmacist named in the notice has
(i) requested in writing that a retraction of the notice be issued, and
(ii) provided a letter from the licensing authority of the province, in which the pharmacist is registered or entitled to practise, in which the authority consents to the retraction of the notice.
G.03.017.4 and G.03.017.5 [Repealed, SOR/2003-135, s. 5]
DIVISION 4
Practitioners
G.04.001 (1) In this section,
administer
administer includes to prescribe, sell or provide; (administrer)
designated drug
designated drug means any of the following controlled drugs:
(a) amphetamine and its salts,
(b) benzphetamine and its salts,
(c) methamphetamine and its salts,
(d) phenmetrazine and its salts, or
(e) phendimetrazine and its salts. (drogue désignée)
(2) Subject to subsections (3) and (4) and to an exemption granted under section 56 of the Controlled Drugs and Substances Act with respect to the administration of the controlled drug specified in the exemption, no practitioner shall administer a controlled drug to any person or animal.
(3) A practitioner may administer a controlled drug, other than a designated drug, to a person or to an animal, if
(a) that person or animal is a patient under his professional treatment; and
(b) the controlled drug is required for the condition for which the patient is receiving treatment.
(4) A practitioner may administer a designated drug to an animal or a person who is a patient under his professional treatment where the designated drug is for the treatment of any of the following conditions:
(a) in humans
(i) narcolepsy,
(ii) hyperkinetic disorders in children,
(iii) mental retardation (minimal brain dysfunction),
(iv) epilepsy,
(v) parkinsonism, or
(vi) hypotensive states associated with anesthesia; or
(b) in animals, depression of cardiac and respiratory centres.
G.04.002 (1) A practitioner who sells or provides a controlled drug to a person for self-administration or for administration to an animal shall, whether or not the practitioner charges for the drug, keep a record showing the name and quantity of the controlled drug sold or provided, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided if the quantity of the controlled drug exceeds
(a) three times the maximum daily dosage recommended by the producer, maker or assembler of the controlled drug; or
(b) three times the generally recognized maximum daily therapeutic dosage for that controlled drug if the producer, maker or assembler has not recommended a maximum daily dosage.
(2) A practitioner who is required by this section to keep a record shall keep the record in a place, form and manner that will permit an inspector readily to examine and obtain information from it.
G.04.002A A practitioner shall
(a) furnish to the Minister on request such information respecting
(i) the use by the practitioner of controlled drugs received — including the administering, selling or providing of the drugs to a person — , and
(ii) the prescriptions for controlled drugs issued by the practitioner,
as the Minister may require;
(b) produce to an inspector on request any records that these Regulations require the practitioner to keep;
(c) permit an inspector to make copies of such records or to take extracts therefrom;
(d) permit an inspector to check all stocks of controlled drugs on the practitioner’s premises;
(e) retain in his possession for at least two years any record that these Regulations require him to keep;
(f) take adequate steps to protect controlled drugs in his possession from loss or theft; and
(g) report to the Minister any loss or theft of a controlled drug within 10 days of the practitioner’s discovery of the loss or theft.
G.04.003 If a practitioner alleges or, in any prosecution for an offence under the Act, the Food and Drugs Act or this Part, pleads that their possession of a controlled drug was for use in their practice or that they administered it to a person or animal, or prescribed, sold or provided it for a person or an animal who or that was a patient under their professional treatment and that the controlled drug was required for the condition for which the patient received treatment, the burden of proof in respect of the allegation or plea shall be on the practitioner.
G.04.004 The Minister shall provide in writing any factual information about a practitioner that has been obtained under the Act or these Regulations to the licensing authority responsible for the registration or authorization of the person to practise their profession
(a) in the province in which the practitioner is registered or entitled to practise if
(i) the authority submits a written request that states the name and address of the practitioner, a description of the information being sought and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or
(ii) the Minister has reasonable grounds to believe that the practitioner has
(A) contravened a rule of conduct established by the authority,
(B) been found guilty in a court of law of a designated drug offence or of a contravention of this Part, or
(C) contravened a provision of this Part; or
(b) in a province in which the practitioner is not registered or entitled to practise, if the authority submits to the Minister
(i) a written request for information that states
(A) the name and address of the practitioner, and
(B) a description of the information being sought, and
(ii) documentation that shows that the practitioner has applied to that authority to practise in that province.
G.04.004.1 A practitioner may make a written request to the Minister to send to licensed dealers and pharmacies a notice, issued under section G.04.004.2, advising them of one or more of the following requirements:
(a) recipients of the notice must not sell or provide a controlled drug, other than a preparation, to that practitioner;
(b) recipients of the notice must not sell or provide a preparation to that practitioner;
(c) pharmacists practising in the notified pharmacies must not fill a prescription or order for a controlled drug, other than a preparation, from that practitioner; and
(d) pharmacists practising in the notified pharmacies must not fill a prescription or order for a preparation from that practitioner.
G.04.004.2 (1) In the circumstances described in subsection (2), the Minister must issue a notice to the persons and authorities specified in subsection (3) advising them that
(a) licensed dealers and pharmacists practising in the notified pharmacies must not sell or provide to the practitioner named in the notice a controlled drug other than a preparation, a preparation, or both; or
(b) pharmacists practising in the notified pharmacies must not fill a prescription or order from the practitioner named in the notice for a controlled drug other than a preparation, a preparation, or both.
(2) The notice must be issued if the practitioner named in the notice has
(a) made a request to the Minister in accordance with section G.04.004.1 to issue the notice;
(b) contravened a rule of conduct established by the licensing authority of the province in which the practitioner is practising and that licensing authority has requested the Minister in writing to issue the notice; or
(c) been found guilty in a court of law of a designated drug offence or of an offence under this Part.
(3) The notice must be issued to
(a) all licensed dealers;
(b) all pharmacies within the province in which the practitioner named in the notice is registered and practising;
(c) the licensing authority of the province in which the practitioner named in the notice is registered or entitled to practise;
(d) any interested licensing authority in another province that has made a request to the Minister to issue the notice; and
(e) all pharmacies in an adjacent province in which a prescription or order from the practitioner named in the notice may be filled.
(4) Subject to subsection (5), the Minister may issue the notice described in subsection (1) to the persons and authorities specified in subsection (3), if the Minister, on reasonable grounds, believes that the practitioner named in the notice
(a) has contravened any of the provisions of sections G.04.001 to G.04.002A;
(b) has, on more than one occasion, self-administered a controlled drug, other than a preparation, under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted medical, dental or veterinary practice;
(c) has, on more than one occasion, self-administered a preparation, under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted medical, dental or veterinary practice;
(d) has, on more than one occasion, prescribed, provided or administered a controlled drug, other than a preparation, to a person who is a spouse, common-law partner, parent or child of the practitioner, including a child adopted in fact, contrary to accepted medical, dental or veterinary practice;
(e) has, on more than one occasion, prescribed, provided or administered a preparation to a person who is a spouse, common-law partner, parent or child of the practitioner, including a child adopted in fact, contrary to accepted medical, dental or veterinary practice; or
(f) is unable to account for the quantity of controlled drug for which the practitioner was responsible under this Part.
(5) In the circumstances described in subsection (4), the Minister must not issue the notice referred to in subsection (1) until the Minister has
(a) consulted with the licensing authority of the province in which the practitioner to whom the notice relates is registered or entitled to practise;
(b) given that practitioner an opportunity to present reasons why the notice should not be issued and considered those reasons; and
(c) considered
(i) the compliance history of the practitioner in respect of the Act and the regulations made or continued under it, and
(ii) whether the actions of the practitioner pose a significant security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use.
G.04.004.3 The Minister must provide the licensed dealers, pharmacies and licensing authorities who were issued a notice under subsection G.04.004.2(1) with a notice of retraction of that notice if
(a) in the circumstance described in paragraph G.04.004.2(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was issued by the Minister; or
(b) in a circumstance described in any of paragraphs G.04.004.2(2)(b) and (c) and (4)(a) to (f), the practitioner named in the notice has
(i) requested in writing that a retraction of the notice be issued, and
(ii) provided a letter from the licensing authority of the province, in which the practitioner is registered or entitled to practise, in which the authority consents to the retraction of the notice.
G.04.004.4 and G.04.004.5 [Repealed, SOR/2003-135, s. 6]
DIVISION 5
Hospitals
G.05.001 (1) A person who is in charge of a hospital shall keep or cause to be kept a record of the following information:
(a) the name and quantity of any controlled drug received for the hospital by a hospital employee or a practitioner in the hospital;
(b) the name and address of the person from whom any controlled drug was received and the date on which it was received;
(c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that controlled drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;
(c.1) the name and quantity of any controlled drug produced and the date on which it was placed in stock;
(d) the name of the patient for whom a controlled drug was dispensed;
(e) the name of the practitioner ordering or prescribing a controlled drug; and
(f) the date on which a controlled drug was ordered or prescribed and the form and quantity thereof.
(2) Subject to subsections (3) and (4), the record of information referred to in subsection (1) shall be kept
(a) in a manner that permits an audit to be made;
(b) in a book, register or similar record maintained exclusively for controlled drugs; and
(c) for a period of at least two years.
(3) The information referred to in paragraphs (1)(d) to (f) may, with respect to a preparation, be kept in a form other than that specified in paragraph (2)(b).
(4) The information referred to in subsection (1) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b).
G.05.002 A person who is in charge of a hospital shall
(a) furnish such information respecting the use of controlled drugs therein, in such form and at such times as the Minister may require;
(b) produce to an inspector any books, records or documents required by these Regulations to be kept;
(c) permit an inspector to make copies thereof or take extracts from such books, records and documents; and
(d) permit an inspector to check all stocks of controlled drugs in the hospital.
G.05.003 (1) No person in charge of a hospital shall permit a controlled drug to be sold, provided or administered except in accordance with this section.
(2) On receipt of a prescription or a written order signed and dated by a practitioner, the person in charge of a hospital may permit a controlled drug to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided to the person or to the person in charge of the animal.
(3) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be provided, for emergency purposes, to a hospital employee or a practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order.
(4) Subject to subsection (6), the person in charge of a hospital may permit a controlled drug to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist.
(5) The person in charge of a hospital may permit a controlled drug to be provided to a person employed in a research laboratory in that hospital for the purpose of research.
(6) No person in charge of a hospital shall permit a controlled drug to be sold or provided under subsection (3) or (4) unless the signature of the pharmacist in the other hospital or of the practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the controlled drug or has been verified.
G.05.004 A person who is in charge of a hospital shall take all steps necessary to protect controlled drugs in the hospital against loss or theft and shall report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof.
Division 6
Authority and Penalty
G.06.001 (1) and (2) [Repealed, SOR/99-125, s. 5]
(3) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a controlled drug in their possession, provide or deliver the drug to
(a) a practitioner of medicine; or
(b) an agent of a practitioner of medicine, where the agent has been exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that controlled drug.
(4) If an agent of a practitioner of medicine receives a controlled drug under subsection (3), they shall immediately provide or deliver it
(a) to the practitioner of whom he is the agent; or
(b) to the Minister or his agent.
(5) A practitioner of medicine who receives a controlled drug under subsection (3) or (4) shall immediately provide or deliver it
(a) for the purpose of identification or analysis thereof, to a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that controlled drug for that purpose; or
(b) to the Minister or his agent.
G.06.002 Every person who is exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession or administration, as the case may be, of a controlled drug shall
(a) keep and retain for a period of two years from the date of the making of the record, a record of
(i) the kind, date and quantity of any controlled drug purchased or received by him,
(ii) the name and address of the person from whom the controlled drug was received, and
(iii) particulars of the use to which the controlled drug was put; and
(b) furnish such information respecting such controlled drugs as the Minister may require, and shall permit access to the records required to be kept by this Part.
Test Kits Containing Controlled Drugs
G.06.002.1 Any person may sell, possess or otherwise deal in a test kit that contains a controlled drug if
(a) a registration number has been issued for the test kit pursuant to section G.06.002.3;
(b) the test kit bears, on its external surface,
(i) the name of the producer, maker or assembler,
(ii) the trade name or trade mark, and
(iii) the registration number issued therefor pursuant to section G.06.002.3;
(c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and
(d) the registration number has not been cancelled pursuant to section G.06.002.4.
G.06.002.2 The manufacturer of a test kit that contains a controlled drug may apply for a registration number therefor by submitting to the Director an application containing
(a) particulars of the design and construction of the test kit;
(b) a detailed description of the controlled drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;
(c) a statement of the proposed use of the test kit; and
(d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued.
G.06.002.3 Where, on application under section G.06.002.2, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it
(a) contains a controlled drug and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or
(b) contains such small quantities or concentrations of any controlled drug as to have no significant drug abuse potential,
the Minister may issue a registration number for the test kit, which shall be a number preceded by the letters “TK”.
G.06.002.4 The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister’s opinion,
(a) it is necessary to cancel the registration number in the interest of public health; or
(b) the test kit is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.
G.06.003 Any person who violates any provision of this Part is guilty of an offence and is liable on summary conviction to a fine not exceeding $500 or to a term of imprisonment not exceeding six months, or to both such fine and imprisonment.
Division 7
General
G.07.001 (1) In this section,
member
member means any person who is registered, certified or otherwise licensed by a nursing statutory body for the practice of nursing; (membre)
nursing statutory body
nursing statutory body means any provincial professional licensing authority that, pursuant to the laws of that province, registers, certifies or otherwise licenses a person for the practice of nursing. (organisme de nursing)
(2) The Minister may provide to a nursing statutory body any information obtained under the Controlled Drugs and Substances Act, the Food and Drugs Act or these Regulations that involves any member of that body.
G.07.002 Where, pursuant to the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Controlled Drugs and Substances Act, the member or person is, in respect of that conduct, exempt from the application of this Part.
SCHEDULE
(Sections G.01.001 and G.01.004, subsection G.02.014(3), subparagraph G.02.025(1)(b)(iii), subsections G.02.025(3.2) and (4) and G.03.001(3), paragraph G.03.006(a), section G.03.007 and subsection G.05.001(4))
PART I
1
Amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues, excluding those substances set out in item 1 of the schedule to Part J but including:
(1)
amphetamine (α-methylbenzeneethanamine)
(2)
methamphetamine (N,α-dimethylbenzeneethanamine)
(3)
Benzphetamine (N-benzyl-N,α-dimethylbenzeneethanamine)
2
Methylphenidate (α-phenyl-2-piperidineacetic acid methyl ester) and any salt thereof
3
Methaqualone (2-methyl-3-(2-methylphenyl)-4(3H)quinazolinone) and any salt thereof
4
Phendimetrazine (d-3,4-dimethyl-2-phenylmorpholine) and any salt thereof
5
Phenmetrazine (3-methyl-2-phenylmorpholine) and any salt thereof
6
Pentobarbital (5-ethyl-5-(1-methylbutyl)barbituric acid)
7
Secobarbital (5-allyl-5-(1-methylbutyl)barbituric acid)
8
4-hydroxybutanoic acid (GHB) and any salt thereof
9
Aminorex (4,5-dihydro-5-phenyl-2-oxazolamine) and any salt thereof
10
Fenetylline (d,l-3,7-dihydro-1,3-dimethyl-7-(2-[(1-methyl-2-phenethyl)amino]ethyl)-1H-purine-2,6-dione) and any salt thereof
11
Glutethimide (2-ethyl-2-phenylglutarimide)
12
Lefetamine ((-)-N,N-dimethyl-α-phenylbenzeneethanamine) and any salt thereof
13
Mecloqualone (2-methyl-3-(2-chlorophenyl)-4(3H)-quinazolinone) and any salt thereof
14
Mesocarb (3-(α-methylphenethyl)-N-(phenylcarbamoyl)sydnone imine) and any salt thereof
15
Pemoline (2-amino-5-phenyl-oxazolin-4-one) and any salt thereof
16
Zipeprol (4-(2-methoxy-2-phenylethyl)-α-(methoxyphenylmethyl)-1-piperazineethanol) and any salt thereof
17
Amineptine (7-[(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid) and any salt thereof
PART II
1
Barbiturates, their salts and derivatives, excluding the substances set out in items 6 and 7 of Part I but including:
(1)
Allobarbital (5,5-diallylbarbituric acid)
(2)
Alphenal (5-allyl-5-phenylbarbituric acid)
(3)
Amobarbital (5-ethyl-5-(3-methylbutyl)barbituric acid)
(4)
Aprobarbital (5-allyl-5-isopropylbarbituric acid)
(5)
Barbital (5,5-diethylbarbituric acid)
(6)
Barbituric Acid (2,4,6(1H,3H,5H)-pyrimidinetrione)
(7)
Butabarbital (5-sec-butyl-5-ethylbarbituric acid)
(8)
Butalbital (5-allyl-5-isobutylbarbituric acid)
(9)
Butallylonal (5-(2-bromoallyl)-5-sec-butylbarbituric acid)
(10)
Butethal (5-butyl-5-ethylbarbituric acid)
(11)
Cyclobarbital (5-(1-cyclohexen-1-yl)-5-ethylbarbituric acid)
(12)
Cyclopal (5-allyl-5-(2-cyclopenten-1-yl)barbituric acid)
(13)
Heptabarbital (5-(1-cyclohepten-1-yl)-5-ethylbarbituric acid)
(14)
Hexethal (5-ethyl-5-hexylbarbituric acid)
(15)
Hexobarbital (5-(1-cyclohexen-1-yl)-1,5-dimethylbarbituric acid)
(16)
Mephobarbital (5-ethyl-1-methyl-5-phenylbarbituric acid)
(17)
Methabarbital (5,5-diethyl-1-methylbarbituric acid)
(18)
Methylphenobarbital (5-ethyl-1-methyl-5-phenylbarbituric acid)
(19)
Propallylonal (5-(2-bromoallyl)-5-isopropyl-barbituric acid)
(20)
Phenobarbital (5-ethyl-5-phenylbarbituric acid)
(21)
Probarbital (5-ethyl-5-isopropylbarbituric acid)
(22)
Phenylmethylbarbituric Acid (5-methyl-5-phenylbarbituric acid)
(23)
Sigmodal(5-(2-bromoallyl)-5-(1-methylbutyl)- barbituric acid)
(24)
Talbutal (5-allyl-5-sec-butylbarbituric acid)
(25)
Vinbarbital (5-ethyl-5-(1-methyl-1-butenyl)barbituric acid)
(26)
Vinylbital (5-(1-methylbutyl)-5-vinylbarbituric acid)
2
Thiobarbiturates, their salts and derivatives, including:
(1)
Thialbarbital (5-allyl-5-(2-cyclohexen-1-yl)-2-thiobarbituric acid)
(2)
Thiamylal (5-allyl-5-(1-methylbutyl)-2-thiobarbituric acid)
(3)
Thiobarbituric Acid (2-thiobarbituric acid)
(4)
Thiopental(5-ethyl-5-(1-methylbutyl)-2- thiobarbituric acid)
3
Chlorphentermine (1-(p-chlorophenyl)-2-methyl-2-aminopropane) and any salt thereof
4
Diethylpropion (2-(diethylamino)propiophenone) and any salt thereof
5
Phentermine (α,α-dimethylbenzeneethanamine) and any salt thereof
6
Butorphanol (1-N-cyclobutylmethyl-3,14-dihydroxy-morphinan) and any salt thereof
7
Nalbuphine (N-cyclobutylmethyl-4,5-epoxy-morphinan-3,6,14-triol) and any salt thereof
8
Pyrovalerone (4′-methyl-2-(1-pyrrolidinyl)valerophenone) and any salt thereof
PART III
1
Anabolic steroids and their derivatives, including:
(1)
Androisoxazole (17ß-hydroxy-17α-methylandrostano[3,2-c]isoxazole)
(2)
Androstanolone (17ß-hydroxy-5α-androstan-3-one)
(3)
Androstenediol (androst-5-ene-3ß,17ß-diol)
(4)
Bolandiol (estr-4-ene-3b,17ß-diol)
(5)
Bolasterone (17ß-hydroxy-7α,17-dimethylandrost-4-en-3-one)
(6)
Bolazine (17ß-hydroxy-2α-methyl-5α-androstan-3-one azine)
(7)
Boldenone (17ß-hydroxyandrosta-1,4-dien-3-one)
(8)
Bolenol (19-nor-17α-pregn-5-en-17-ol)
(9)
Calusterone (17ß-hydroxy-7b,17-dimethylandrost-4-en-3-one)
(10)
Clostebol (4-chloro-17ß-hydroxyandrost-4-en-3-one)
(11)
Drostanolone (17ß-hydroxy-2α-methyl-5α-androstan-3-one)
(12)
Enestebol (4,17ß-dihydroxy-17-methylandrosta-1,4-dien-3-one)
(13)
Epitiostanol (2α, 3α-epithio-5α-androstan-17ß-ol)
(14)
Ethylestrenol (19-nor-17α-pregn-4-en-17-ol)
(15)
4-Hydroxy-19-nor testosterone
(16)
Fluoxymesterone (9-fluoro-11ß,17ß-dihydroxy—17-methylandrost-4-en-3-one)
(17)
Formebolone (11α,17ß-dihydroxy-17-methyl-3-oxoandrosta-1,4-dien-2-carboxaldehyde)
(18)
Furazabol (17-methyl-5α-androstano[2,3-c]furazan-17ß-ol)
(19)
Mebolazine (17ß-hydroxy-2α,17-dimethyl-5α-androstan-3-one azine)
(20)
Mesabolone (17ß-[(1-methoxycyclohexyl)oxy]-5α-androst-1-en-3-one)
(21)
Mesterolone (17ß-hydroxy-1α-methyl-5α-androstan-3-one)
(22)
Metandienone (17ß-hydroxy-17-methylandrosta-1,4-dien-3-one)
(23)
Metenolone (17ß-hydroxy-1-methyl-5α-androst-1-en-3-one)
(24)
Methandriol (17α-methylandrost-5-ene-3ß,17ß-diol)
(25)
Methyltestosterone (17ß-hydroxy-17-methyl-androst-4-en-3-one)
(26)
Metribolone (17ß-hydroxy-17-methylestra-4,9,11-trien-3-one)
(27)
Mibolerone (17ß-hydroxy-7α,17-dimethylestr-4-en-3-one)
(28)
Nandrolone (17ß-hydroxyestr-4-en-3-one)
(29)
Norboletone (13-ethyl-17ß-hydroxy-18,19-dinorpregn-4-en-3-one)
(30)
Norclostebol (4-chloro-17ß-hydroxyestr-4-en-3-one)
(31)
Norethandrolone (17α-ethyl-17ß-hydroxyestr-4-en-3-one)
(32)
Oxabolone (4,17ß-dihydroxyestr-4-en-3-one)
(33)
Oxandrolone (17ß-hydroxy-17-methyl-2-oxa-5α-androstan-3-one)
(34)
Oxymesterone (4,17ß-dihydroxy-17-methylandrost-4-en-3-one)
(35)
Oxymetholone (17ß-hydroxy-2-(hydroxymethylene)-17-methyl-5α-androstan-3-one)
(36)
Prasterone (3ß-hydroxyandrost-5-en-17-one)
(37)
Quinbolone (17ß-(1-cyclopenten-1-yloxy)androsta-1,4-dien-3-one)
(38)
Stanozolol (17ß-hydroxy-17-methyl-5α-androstano[3,2-c]pyrazole)
(39)
Stenbolone (17ß-hydroxy-2-methyl-5α-androst-1-en-3-one)
(40)
Testosterone (17ß-hydroxyandrost-4-en-3-one)
(41)
Tibolone ((7α,17α)-17-hydroxy-7-methyl-19-norpregn-5(10)en-20-yn-3-one)
(42)
Tiomesterone (1α,7α-bis(acetylthio)-17ß-hydroxy-17-methylandrost-4-en-3-one)
(43)
Trenbolone (17ß-hydroxyestra-4,9,11-trien-3-one)
2
Zeranol (3,4,5,6,7,8,9,10,11,12-decahydro-7,14,16-trihydroxy-3-methyl-1H-2-benzoxacyclotetradecin-1-one)
PART J
Restricted Drugs
Division 1
General
J.01.001 In this Part,
competent authority
competent authority means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of restricted drugs into or from the country; (autorité compétente)
institution
institution means any institution engaged in research on drugs and includes a hospital that is licensed by a province, a university, a department or agency of the Government of Canada or of a province or any part thereof; (établissement)
international obligation
international obligation means an obligation in respect of a restricted drug set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres; (obligation internationale)
licence
licence[Repealed, SOR/2004-238, s. 31]
licensed dealer
licensed dealer means the holder of a licence issued under section J.01.007.2; (distributeur autorisé)
permit
permit means a permit issued under section J.01.005; (permis)
practitioner
practitioner means a person who is registered and entitled under the laws of a province to practise the profession of medicine; (praticien)
qualified investigator
qualified investigator means, in respect to a restricted drug, a person who
(a) is employed by or is connected with an institution, or
(b) is engaged in research in an institution in respect of that drug,
and whose use and possession of that drug is authorized by the Minister pursuant to section J.01.018; (chercheur compétent)
qualified person in charge
qualified person in charge means the individual with the qualifications specified in subsection J.01.003.2(2) who is responsible for supervising the activities carried out by a licensed dealer under their licence at the premises specified in the licence; (personne qualifiée responsable)
restricted drug
restricted drug means a drug set out in the schedule to this Part; (drogue d’usage restreint)
test kit
test kit means an apparatus
(a) that contains reagent systems or buffering agents or both,
(b) that is used in the course of a chemical or analytical procedure for medical, laboratory, industrial, educational or research purposes, and
(c) the contents of which are not intended for administration to humans. (nécessaire d’essai)
Possession
J.01.002 (1) The following persons may have a restricted drug in their possession:
(a) a licensed dealer;
(b) a qualified investigator if he has possession for the purpose of and in connection with research in an institution;
(c) an analyst, inspector, member of the Royal Canadian Mounted Police, constable, peace officer, member of the staff of the Department of National Health and Welfare or officer of a court, if such person has possession for the purpose and in connection with his employment; and
(d) a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to that restricted drug.
(2) A person is authorized to have a restricted drug in his possession if the person is acting as the agent for a person referred to in paragraph (1)(a), (b) or (d).
(2.1) A person is authorized to have a restricted drug in his possession where
(a) the person is acting as the agent for a person he has reasonable grounds to believe is a person referred to in paragraph (1)(c); and
(b) the possession of the restricted drug is for the purpose of assisting that person in the enforcement or administration of an Act or regulation.
Licences, Permits and Licensed Dealers
J.01.003 Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a restricted drug.
J.01.003.1 To be eligible for a dealer’s licence, a person must be
(a) an individual who ordinarily resides in Canada;
(b) a corporation that has its head office in Canada or operates a branch office in Canada; or
(c) the holder of a position that includes responsibility for restricted drugs on behalf of a department of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.
J.01.003.2 (1) A licensed dealer
(a) shall designate no more than one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to restricted drugs specified in the licence and for ensuring, on behalf of the licensed dealer, that those activities comply with these Regulations; and
(b) may designate an alternate qualified person in charge who must work at the premises set out in the licence and have authority to replace the qualified person in charge when that person is absent.
(2) The qualified person in charge and, if applicable, the alternate qualified person in charge
(a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;
(b) shall be a pharmacist or a practitioner registered with a licensing body of a province or possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and
(c) shall not have been convicted, as an adult, within the previous 10 years, of
(i) a designated drug offence,
(ii) a designated criminal offence, or
(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).
J.01.004 No licensed dealer shall import or export a restricted drug without a permit.
J.01.004.1 A licensed dealer is authorized to have a restricted drug in his possession for the purpose of exporting the restricted drug from Canada if he has obtained the restricted drug pursuant to these Regulations.
J.01.005 The Minister may, upon application therefor, after such investigation as he deems proper and subject to such terms and conditions as he deems proper, issue to any licensed dealer a permit for the importation or exportation of a restricted drug.
J.01.006 An application for a permit shall be in a form approved by the Minister.
J.01.007 (1) To apply for a dealer’s licence, a person shall submit an application to the Minister containing
(a) if the licence is sought for
(i) an individual, the individual’s name,
(ii) a corporation, the corporation’s name and any other name registered with a province, under which it intends to carry out the activities specified in its dealer’s licence or intends to identify itself; and
(iii) the holder of a position mentioned in paragraph J.01.003.1(c), the applicant’s name and the title of the position;
(b) the address, telephone number and, if applicable, the facsimile transmission number and e-mail address for the premises to which the dealer’s licence would apply and, if different, the mailing address for the premises;
(c) the name, date of birth and gender of the individual in charge of the premises;
(d) with respect to the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises,
(i) their name, date of birth and gender,
(ii) their academic qualifications, training and work experience relevant to their duties,
(iii) their hours of work, at the premises,
(iv) their title at the premises,
(v) the name and title of their immediate supervisor at the premises, and
(vi) in the case of a pharmacist or a practitioner, the name of the province in which the person’s current professional licence, certification or authorization was issued and the professional licence, certification or authorization number;
(e) the name and gender of the individuals authorized to place an order for a restricted drug on behalf of the applicant;
(f) the activities referred to in section J.01.003 for which the licence is sought that would be carried out at the premises to which the dealer’s licence would apply;
(g) in the case of a product or compound that contains a restricted drug but is not a test kit and that would be made or assembled for or by the applicant, a list that sets out
(i) the name, number or identifying mark, if any, of each product or compound,
(ii) the restricted drug in each product or compound,
(iii) the strength per unit of the restricted drug in each product or compound,
(iv) the quantity or package sizes of each product or compound, and
(v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and the dealer’s licence number of the other dealer;
(h) if the licence is sought to produce a restricted drug other than a product or compound that contains a restricted drug
(i) the restricted drug to be produced,
(ii) the quantity that the applicant expects to produce under the dealer’s licence and the period during which that quantity would be produced, and
(iii) if the restricted drug would be produced for another licensed dealer under a custom order, the name, address and licence number of the other dealer;
(i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive;
(j) a detailed description of the method that the applicant proposes to use for recording their restricted drug transactions; and
(k) for any activity referred to in section J.01.003, other than the activities described in paragraphs (g) and h), the restricted drug and the purpose for carrying out the activity.
(2) An application for a dealer’s licence must
(a) be signed by the individual in charge of the premises to which the licence would apply; and
(b) be accompanied by a statement signed by the individual in charge indicating that
(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii) the individual in charge has the authority to bind the applicant.
(3) An application for a dealer’s licence must be accompanied by
(a) declarations signed by the individual in charge of the premises, the qualified person in charge and, if applicable, the alternate qualified person in charge, stating that they have not been convicted, as an adult, during the previous 10 years of
(i) a designated drug offence,
(ii) a designated criminal offence, or
(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);
(b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the preceding 10 years of a designated drug offence or a designated criminal offence;
(c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada;
(d) a statement, signed and dated by the individual in charge of the premises, stating that the qualified person in charge and, if applicable, the alternate qualified person in charge have the knowledge and experience required under paragraph J.01.003.2(2)(a);
(e) if the qualified person in charge or, if applicable, the alternate qualified person in charge is not a pharmacist or a practitioner registered with a licensing body of a province, a copy of the person’s degree required under paragraph J.01.003.2(2)(b) and a copy of the course transcript for that degree;
(f) if the applicant’s name appears on the label of a product or compound that contains a restricted drug, a copy of the inner label, as defined in section A.01.010, for each product or compound to which the licence would apply; and
(g) if the applicant is a corporation, a copy of
(i) the certificate of incorporation or other constituting instrument, and
(ii) any document filed with the province in which the premises to which the licence would apply are located that states its corporate name or any other name registered with the province, under which the applicant intends to carry out the activities specified in its dealer’s licence or intends to identify itself.
(4) The method proposed by the applicant under paragraph (1)(j) must
(a) allow for the recording of restricted drug transactions in accordance with section J.01.021; and
(b) permit the Minister to audit the activities of the licensed dealer with respect to restricted drugs.
(5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing
(a) to having a criminal record check carried out for them, as an adult, in respect of the offences referred to in those paragraphs during the preceding 10 years;
(b) to provide all information and to submit to any means of identification required to obtain criminal record check; and
(c) to pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations.
J.01.007.1 The Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application.
J.01.007.2 Subject to section J.01.007.3, the Minister shall, after examining the information and documents required under sections J.01.007 and J.01.007.1, issue a dealer’s licence that contains
(a) the licence number;
(b) the name of the applicant or the title of the position they hold, as the case may be, or, if the applicant is a corporation, its corporate name;
(c) a list of the activities that are permitted;
(d) the address of the premises at which the licensed dealer may carry on the permitted activities;
(e) the name of the restricted drug for which the activities are permitted;
(f) the security level at the premises;
(g) the effective date of the licence;
(h) the expiry date of the licence, which may not be later than three years after its effective date;
(i) any conditions to be met by the holder of the licence to
(i) ensure that an international obligation is respected,
(ii) provide the security level referred to in paragraph (f), or
(iii) reduce the potential security, public health or safety hazard, including the risk of the restricted drug being diverted to an illicit market or use;
(j) in the case of a producer of a restricted drug, the quantity of the restricted drug that may be produced under the licence and the period during which that quantity may be produced; and
(k) in the case of the maker or assembler of a product or compound that contains a restricted drug but is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:
(i) the licence number,
(ii) the name, number or identifying mark, if any, of each product or compound,
(iii) the restricted drug in each product or compound,
(iv) the strength per unit of the restricted drug in each product or compound, and
(v) the quantity or package sizes of each product or compound.
J.01.007.3 (1) The Minister shall refuse to issue, renew or amend a dealer’s licence if
(a) the applicant is not eligible under section J.01.003.1;
(b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section J.01.025;
(c) false or misleading information or false or falsified documents were submitted in or with the application;
(d) an activity for which the licence is requested would not be in compliance with an international obligation;
(e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation;
(f) the applicant does not have in place the security measures set out in the Security Directive in respect of an activity for which the licence is requested;
(g) the applicant is in contravention of or has contravened during the preceding 10 years
(i) a provision of the Act or any regulations made or continued under the Act, or
(ii) a term or condition of another dealer’s licence or of an import or export permit issued to the applicant under any regulations made or continued under the Act;
(h) the issuance, amendment or renewal of the licence would likely create a risk to public health, safety or security, including the risk of a restricted drug being diverted to an illicit market or use;
(i) the individual in charge of the premises, the qualified person in charge or, if applicable, the alternate qualified person in charge has been convicted, as an adult, within the previous 10 years, of
(i) a designated drug offence,
(ii) a designated criminal offence, or
(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);
(j) the proposed method referred to in paragraph J.01.007(1)(j) is not capable of recording the applicant’s restricted drug transactions as required under section J.01.023 or permitting the Minister to audit the applicant’s activities with respect to restricted drugs in a timely manner; or
(k) the additional information required under section J.01.007.1 has not been provided or is insufficient to process the application.
(2) The Minister is not required to refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant
(a) does not have a history of non compliance with the Act or any regulation made or continued under it; and
(b) has carried out, or signed an undertaking to carry out, specified corrective measures to ensure compliance with the Act and these Regulations.
J.01.007.4 (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister
(a) the information required under paragraphs J.01.007(1)(a) to (k); and
(b) the following documents, namely,
(i) the documents referred to in paragraphs J.01.007(3)(a) and (d) and, subject to subsection J.01.007(5), the document specified in paragraph J.01.007(3)(b),
(ii) if applicable and if not previously submitted in respect of the dealer’s licence that is being renewed, the document referred to in paragraph J.01.007(3)(e), and
(iii) the original dealer’s licence that is to be renewed.
(2) An application for renewal must
(a) be signed by the individual in charge of the premises to which the renewed dealer’s licence would apply; and
(b) be accompanied by a statement signed by the individual in charge indicating that
(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii) the individual in charge has the authority to bind the applicant.
(3) Subject to section J.01.007.3, the Minister shall, after examining the information and documents required under subsections (1) and (2) and section J.01.007.1, issue a renewed dealer’s licence that contains the information specified in paragraphs J.01.007.2(a) to (k).
J.01.007.5 (1) To have its dealer’s licence amended, a licensed dealer shall submit to the Minister
(a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section J.01.007 that are relevant to the proposed amendment; and
(b) the original dealer’s licence.
(2) An application for amendment must
(a) be signed by the individual in charge of the premises to which the amended dealer’s licence would apply; and
(b) be accompanied by a statement signed by the individual in charge indicating that
(i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii) the individual in charge has the authority to bind the applicant.
(3) Subject to section J.01.007.3, the Minister shall, after examining the request for amendment and the supporting documentation, amend the dealer’s licence in accordance with the request and may add any conditions to be met by the holder of the licence to
(a) ensure that an international obligation is respected;
(b) provide for the security level referred to in paragraph J.01.007.2(f) or the new level required as a result of the amendment being implemented; or
(c) reduce the potential security, public health or safety hazard, including the risk of the restricted drug being diverted to an illicit market or use.
J.01.007.6 (1) A licensed dealer shall
(a) obtain the Minister’s approval before making any of the following changes, namely,
(i) a change relating to the security at the premises referred to in the dealer’s licence, or
(ii) the replacement or the addition of
(A) an individual in charge of the premises to which the dealer’s licence applies,
(B) a qualified person in charge and, if applicable, an alternate qualified person in charge at the premises to which the dealer’s licence applies, and
(C) an individual authorized to place an order for a restricted drug on behalf of the licensed dealer;
(b) notify the Minister, not later than 10 days after the change, when a person referred to in clause (a)(ii)(A) or (C) ceases to carry out their duties as specified in
(i) the application for a dealer’s licence under section J.01.007,
(ii) the application to renew a dealer’s licence under section J.01.007.4, or
(iii) the request for approval under paragraph (a); and
(c) notify the Minister, not later than the next business day after the change, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as specified in
(i) the application for a dealer’s licence under section J.01.007,
(ii) the application to renew a dealer’s licence under section J.01.007.4, or
(iii) the request for approval under paragraph (a).
(2) The licensed dealer shall, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person:
(a) in the case of the replacement of the individual in charge of the premises to which the dealer’s licence applies,
(i) the information specified in paragraph J.01.007(1)(c), and
(ii) the declarations specified in paragraph J.01.007(3)(a) and, subject to subsection J.01.007(5), the documents specified in paragraphs J.01.007(3)(b) and (c);
(b) in the case of the replacement of the qualified person in charge or the replacement or addition of the alternate qualified person in charge at the premises to which the dealer’s licence applies,
(i) the information specified in paragraph J.01.007(1)(d), and
(ii) the documents specified in paragraphs J.01.007(3)(a), (d) and (e) and, subject to subsection J.01.007(5), the documents specified in paragraphs J.01.007(3)(b) and (c); and
(c) in the case of the replacement or addition of an individual who is authorized to place an order for a restricted drug on behalf of the licensed dealer, the individual’s name and gender.
J.01.007.7 The Minister shall revoke a dealer’s licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen.
J.01.007.8 (1) Subject to subsection (2), the Minister shall revoke a dealer’s licence in accordance with section J.01.007.91 if
(a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application;
(b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under this Part;
(c) the licensed dealer is no longer an eligible person under section J.01.003.1;
(d) it is discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises, has been convicted, as an adult, within the previous 10 years, of
(i) a designated drug offence,
(ii) a designated criminal offence, or
(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or
(e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use.
(2) The Minister is not required to revoke a dealer’s licence under paragraphs (1)(a) or (b) if the licensed dealer
(a) has no history of non-compliance with the Act and the regulations made or continued under it; and
(b) has carried out, or signed an undertaking to carry out, corrective measures to ensure compliance with the Act and these Regulations.
J.01.007.9 The Minister shall suspend a dealer’s licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a restricted drug from being diverted to an illicit market or use.
J.01.007.91 (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a licence under this Part, the Minister shall
(a) send a notice to the applicant or to the holder of the licence, together with a written report that sets out the reasons for the proposed refusal or revocation; and
(b) give the applicant or holder an opportunity to be heard in respect of the proposed refusal or revocation.
(2) The suspension of a licence under this Part takes effect as soon as the Minister informs the holder of the licence of the decision to suspend and provides a written report that sets out the reasons for the suspension.
(3) A person who receives a notice of suspension referred to in subsection (2) may, in the 10 days following the receipt of the notice, provide the Minister with reasons why the suspension of the licence is unfounded.
J.01.008 [Repealed, SOR/2004-238, s. 33]
J.01.009 The Minister may impose such restrictions and conditions on a licensed dealer as he deems necessary for the control of a restricted drug.
J.01.010 A licensed dealer may at any time make an application to the Minister to amend his licence in order to become a licensed dealer in respect of a restricted drug other than a restricted drug specified in his licence or to change the terms or conditions of his licence.
J.01.011 A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only the restricted drugs specified in their dealer’s licence.
J.01.012 The Minister shall revoke or suspend a permit issued under this Part if the Minister determines that the person to whom it was issued has failed to comply with any term or condition of the permit or any provision of this Part.
J.01.013 A dealer’s licence is valid until the earlier of
(a) the expiry date set out in the licence, and
(b) the revocation or suspension of the licence under section J.01.007.7, J.01.007.8 or J.01.007.9.
J.01.014 A permit is valid only for the particular importation or exportation in respect of which it was issued.
Sale of a Restricted Drug
J.01.015 An institution may, in a form approved by the Minister, make an application to a licensed dealer or to the Minister with respect to the purchase of a restricted drug
(a) for clinical use in the institution by qualified investigators for the purpose of determining the hazards and efficacy of the drug; or
(b) for laboratory research in the institution by qualified investigators.
J.01.016 Where a licensed dealer receives an application made pursuant to section J.01.015, he shall, before selling a restricted drug to the institution that made the application
(a) supply the Minister with a copy of the application; and
(b) obtain the written authority of the Minister to make the proposed sale of the restricted drug.
J.01.017 An application made pursuant to section J.01.015 shall contain
(a) the name and the address of the institution seeking to purchase the drug;
(b) the names and qualifications of the qualified investigators who will use and be in possession of the drug;
(c) the details of the proposed use of the drug;
(d) the quantity of the drug required;
(e) the dosage form of the drug required by the institution; and
(f) the name of the licensed dealer from whom the purchase of the drug will be made.
J.01.018 Where the Minister receives from an institution an application or a copy of an application made pursuant to section J.01.015, he may, subject to such qualifications and limitations as he deems proper, authorize
(a) the sale to the institution by a licensed dealer of the restricted drug applied for in such quantity and such dosage form as he deems proper; and
(b) qualified investigators to make clinical use of the restricted drug in the institution or to carry out laboratory research with the restricted drug in the institution and to possess the restricted drug for the purposes of such use or research.
J.01.019 An institution shall use a restricted drug only for the purpose and in accordance with the protocol therefor set out in the application respecting that restricted drug made pursuant to section J.01.015.
J.01.020 Where a licensed dealer is authorized under section J.01.018 to sell a restricted drug, he may, notwithstanding section C.08.002, sell that drug subject to any qualifications or limitations imposed by the Minister.
Records and Inspection
J.01.021 Every institution shall keep and retain for a period of two years from the date of the making of the record, a record of
(a) the amount of every restricted drug received by the institution;
(b) details of the use of restricted drugs in the institution;
(c) the names and qualifications of every person who makes use of a restricted drug in the institution; and
(d) full clinical data with respect to the use of every restricted drug received by the institution.
J.01.022 Every institution shall make its records referred to in section J.01.021 available to the Minister upon his request and shall permit such inspection of the institution, respecting its use of restricted drugs, as the Minister may require.
J.01.023 Every licensed dealer shall maintain a record of
(a) the name, quantity and form of any restricted drug received by them, the name and address of the person who sold or provided it and the date it was received;
(b) the name, quantity and form of any restricted drug sold or provided by them, the name and address of the person to whom it was sold or provided and the date it was sold or provided;
(c) the name, quantity and form of any restricted drug they have used in making or assembling a product or compound containing that restricted drug, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;
(d) the name and quantity of any restricted drug produced and the date on which it was placed in stock; and
(e) the name, quantity and form of any restricted drug he has in stock.
J.01.024 Every licensed dealer and every person who has been a licensed dealer shall keep the record referred to in section J.01.023 on the premises described in the licence that was issued to him or in such other place as may be approved by the Minister for a period of at least two years and shall keep such record in a form that will facilitate an audit thereof being made at any time.
J.01.025 (1) The Minister may, in respect of an applicant for a dealer’s licence or a licensed dealer, require an inspection, at any reasonable time, of
(a) the premises used or intended to be used in producing, making, assembling or storing a restricted drug; and
(b) the process and conditions of the producing, making, assembling or storing.
(2) The Minister may, in respect of a licensed dealer, require a verification to be made, at any reasonable time, of the qualifications of its technical staff concerned with producing, making, assembling or storing a restricted drug.
J.01.026 Every person who sells or provides a restricted drug shall
(a) supply such information in such form as the Minister may require respecting the dealings of any person in the restricted drug;
(b) produce to an inspector any books, records or documents required to be kept under this Part;
(c) permit an inspector to make copies of or to take extracts from any books, records and documents; and
(d) permit an inspector to check all stocks of restricted drugs located on the premises described in his licence.
J.01.027 Every licensed dealer shall notify the Minister forthwith of any change
(a) in his technical staff concerned with a restricted drug;
(b) in the premises in which a restricted drug is produced, made, assembled or stored; and
(c) in the process and conditions of producing, making, assembly or storage of a restricted drug.
J.01.028 Every person who is in possession of a restricted drug and every institution to which the sale of a restricted drug has been authorized by the Minister shall
(a) provide such protection against loss or theft of the restricted drug as may be required by the Minister; and
(b) report forthwith to the Minister and to local law enforcement authorities any loss or theft of a restricted drug.
J.01.029 Where a licensed dealer delivers a restricted drug, he shall
(a) take such steps as are necessary to ensure the safekeeping of the drug during transit; and
(b) use such methods of transportation as will ensure that an accurate record is kept of the drug while in transit and of the signatures of any persons having charge of the drug until it is delivered to the consignee.
Packaging and Labelling
J.01.030 Every restricted drug that is sold to an institution shall be securely packed by the licensed dealer who sells the drug in such a manner that the package cannot be opened without breaking the seal.
J.01.031 The provisions of section C.01.004 do not apply to a restricted drug.
J.01.032 Every package that contains a restricted drug shall be labelled so that the inner and outer labels thereon show
(a) the proper name or, if there is no proper name, the common name of the drug;
(b) the net contents of the package;
(c) the unit strength of the drug where it is in unit form;
(d) the lot number of the drug;
(e) the words “Restricted Drug”; and
(f) the name and address of the producer, maker or assembler of the drug.
J.01.032.1 Section J.01.032 does not apply to a test kit that contains a restricted drug where a registration number has been issued for the test kit pursuant to section J.01.033.3 and has not been cancelled pursuant to section J.01.033.4.
J.01.033 (1) and (2) [Repealed, SOR/99-125, s. 8]
(3) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a restricted drug, provide or deliver the restricted drug that they have in their possession to
(a) a practitioner; or
(b) an agent of a practitioner, where the agent has been exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that restricted drug for that purpose.
(4) if an agent of a practitioner has received a restricted drug under subsection (3), the agent shall immediately provide or deliver it
(a) to the practitioner of whom he is the agent; or
(b) to the Minister or his agent.
(5) A practitioner who has received a restricted drug under subsection (3) or (4) shall immediately provide or deliver it
(a) for the purpose of identification or analysis thereof, to a person exempted under section 56 of the Controlled Drugs and Substances Act with respect to the possession of that restricted drug for that purpose; or
(b) to the Minister.
(6) Sections J.01.021 and J.01.022 apply with such modifications as the circumstances may require to every person who has received a restricted drug pursuant to this section other than a person to whom a restricted drug has been administered pursuant to an exemption granted under section 56 of the Controlled Drugs and Substances Act with respect to the administration of that drug.
Test Kits Containing Restricted Drugs
J.01.033.1 Any person may sell, possess or otherwise deal in a test kit that contains a restricted drug if
(a) a registration number has been issued for the test kit pursuant to section J.01.033.3;
(b) the test kit bears, on its external surface,
(i) the name of the producer, maker or assembler,
(ii) the trade name or trade mark, and
(iii) the registration number issued therefor pursuant to section J.01.033.3;
(c) the test kit is sold, possessed or otherwise dealt in for the purpose of medical, laboratory, industrial, educational or research use; and
(d) the registration number has not been cancelled pursuant to section J.01.033.4.
J.01.033.2 The manufacturer of a test kit that contains a restricted drug may apply for a registration number therefor by submitting to the Director an application containing
(a) particulars of the design and construction of the test kit;
(b) a detailed description of the restricted drug and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component;
(c) a statement of the proposed use of the test kit; and
(d) any further information and material that the Minister may require in order to satisfy himself that the test kit is one for which a registration number may be issued.
J.01.033.3 Where, on application under section J.01.033.2, the Minister is satisfied that the test kit to which the application applies will only be used for medical, laboratory, industrial, educational or research use and that it
(a) contains a restricted drug and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential, or
(b) contains such small quantities or concentrations of any restricted drug as to have no significant drug abuse potential,
the Minister may issue a registration number for the test kit, which shall be a number preceded by the letters “TK”.
J.01.033.4 The Minister may cancel the registration number for a test kit if the test kit is removed from the market by the manufacturer or if, in the Minister’s opinion,
(a) it is necessary to cancel the registration number in the interest of public health; or
(b) the test kit is used or is likely to be used for any purpose other than medical, laboratory, industrial, educational or research use.
Prescribed Manner of Notice of Application for an Order of Restoration
J.01.035 (1) For the purpose of subsection 24(1) of the Controlled Drugs and Substances Act, notice of application for an order of restoration shall be given in writing to the Attorney General by registered mail.
(2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application is to be made to the magistrate and shall specify
(a) the magistrate to whom the application is to be made;
(b) the time and place where the application is to be heard;
(c) the restricted drug or other thing in respect of which the application is to be made; and
(d) the evidence upon which the applicant intends to rely to establish that he is entitled to possession of the restricted drug or other thing referred to in paragraph (c).
J.01.036 Where, pursuant to the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Controlled Drugs and Substances Act, the member or person is, in respect of that conduct, exempt from the application of this Part.
SCHEDULE
(Section J.01.001)
1
The following amphetamines, their salts, derivatives, isomers and analogues and salts of derivatives, isomers and analogues:
(1)
N-ethylamphetamine (N-ethyl-α-methylbenzeneethanamine)
(2)
4-methyl-2,5-dimethoxyamphetamine (STP) (2,5-dimethoxy-4,α-dimethylbenzeneethanamine)
(3)
3,4-methylenedioxyamphetamine (MDA) (α-methyl-1,3-benzodioxole-5-ethanamine)
(4)
2,5-dimethoxyamphetamine(2,5-dimethoxy-α-methylbenzeneethanamine)
(5)
4-methoxyamphetamine (4-methoxy-α-methylbenzeneethanamine)
(6)
2,4,5-trimethoxyamphetamine (2,4,5-trimethoxy-α-methylbenzeneethanamine)
(7)
N-methyl-3,4-methylenedioxyamphetamine (N,α-dimethyl-1,3-benzodioxole-5-ethanamine)
(8)
4-ethoxy-2,5-dimethoxyamphetamine (4-ethoxy-2,5-dimethoxy-α-methylbenzeneethanamine)
(9)
5-methoxy-3,4-methylenedioxyamphetamine (7-methoxy-α-methyl-1,3-benzodioxole-5-ethanamine)
(10)
N,N-dimethyl-3,4-methylenedioxyamphetamine (N,N, α-trimethyl-1,3-benzodioxole-5-ethanamine)
(11)
N-ethyl-3,4-methylenedioxyamphetamine (N-ethyl-α-methyl-1,3-benzodioxole-5-ethanamine)
(12)
4-ethyl-2,5-dimethoxyamphetamine (DOET) (4-ethyl-2,5-dimethoxy-α-methylbenzeneethanamine)
(13)
4-bromo-2,5-dimethoxyamphetamine (4-bromo-2,5-dimethoxy-α-methylbenzeneethanamine)
(14)
4-chloro-2,5-dimethoxyamphetamine (4-chloro-2,5-dimethoxy-α-methylbenzeneethanamine)
(15)
4-ethoxyamphetamine (4-ethoxy-α-methyl-benzeneethanamine)
(16)
N-Propyl-3,4-methylenedioxyamphetamine (α-methyl-N-propyl-1,3-benzodioxole-5-ethanamine)
(17)
N-hydroxy-3,4-methylenedioxyamphetamine (N-[α-methyl-3,4-(methylenedioxy)phenethyl]hydroxylamine)
(18)
3,4,5-trimethoxyamphetamine (3,4,5-trimethoxy-α-methylbenzeneethanamine)
2
Lysergic acid diethylamide (LSD) (N,N-diethyllysergamide) and any salt thereof
3
N,N-Diethyltryptamine (DET) (3-[(2-diethylamino)ethyl]indole) and any salt thereof
4
N,N-Dimethyltryptamine (DMT) (3-[(2-dimethylamino)ethyl]indole) and any salt thereof
5
N-Methyl-3-piperidyl benzilate (LBJ) (3-[(hydroxydiphenylacetyl)oxy]-1-methylpiperidine) and any salt thereof
6
Harmaline (4,9-dihydro-7-methoxy-1-methyl-3H-pyrido(3,4-b)indole) and any salt thereof
7
Harmalol (4,9-dihydro-1-methyl-3H-pyrido(3,4-ß)indol-7-ol) and any salt thereof
8
Psilocin (3-[2-(dimethylamino)ethyl]-4-hydroxyindole) and any salt thereof
9
Psilocybin (3-[2-(dimethylamino)ethyl]-4-phosphoryloxyindole) and any salt thereof
10
N-(1-phenylcyclohexyl)ethylamine (PCE) and any salt thereof
11
1-[1-(2-Thienyl)cyclohexyl]piperidine (TCP) and any salt thereof
12
1-Phenyl-N-propylcyclohexanamine and any salt thereof
13
Mescaline (3,4,5-trimethoxybenzeneethanamine) and any salt thereof, but not peyote (lophophora)
14
4-Methylaminorex (4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine) and any salt thereof
15
2-Methylamino-1-phenyl-1-propanone and any salt thereof
16
1-[1-(Phenylmethyl)cyclohexyl]piperidine and any salt thereof
17
1-[1-(4-Methylphenyl)cyclohexyl]piperidine and any salt thereof
18
Etryptamine (3-(2-aminobutyl)indole) and any salt thereof
19
Rolicyclidine (1-(1-phenylcyclohexyl) pyrrolidine) and any salt thereof
SCHEDULE F
(Sections C.01.001, C.01.041 to C.01.047, C.01.601 and C.10.005)
Part I
Abacavir and its salts
Abacavir et ses sels
Abciximab
Abciximab
Acarbose and its derivatives
Acarbose et ses dérivés
Acebutolol and its salts
Acébutolol et ses sels
Acetazolamide
Acétazolamide
Acetohexamide
Acétohexamide
Acetylcarbromal
Acétylcarbromal
Acetylcholine Chloride
Acétylcholine (chlorure d’)
Acitretin and its salts and derivatives
Acitrétine, ses sels et dérivés
Aconiazide and its salts
Aconiazide et ses sels
Acyclovir and its salts
Acyclovir et ses sels
Adapalene and its salts and derivatives
Adapalène, ses sels et dérivés
Adefovir and its salts and derivatives
Adéfovir, ses sels et dérivés
Adenosine and its salts, when sold or recommended for administration by intravenous injection
Adénosine et ses sels, s’il est vendu ou recommandé pour administration par injection intraveineuse
Alatrofloxacin and its salts and derivatives
Alatrofloxacine et ses sels et dérivés
Aldesleukin
Aldésleukine
Alendronic acid and its salts
Alendronique (acide) et ses sels
Alfacalcidol
Alfacalcidol
Alfuzosin and its salts
Alfuzosine et ses sels
Alkyl nitrites
Alkyle (nitrites d’)
Allopurinol
Allopurinol
Allylisopropylacetylurea
Allylisopropylacétylurée
Almotriptan and its salts
Almotriptan et ses sels
Alpha-chloralose
Alpha-chloralose
Alphadolone and its salts
Alphadolone et ses sels
Alphaxalone
Alfaxalone
Alteplase and its salts and derivatives
Altéplase, ses sels et dérivés
Altrenogest
Altrénogest
Altretamine
Altrétamine
Amantadine and its salts
Amantadine et ses sels
Ambenonium Chloride
Ambénonium (chlorure d’)
Amifostine and its salts
Amifostine et ses sels
Amikacin and its salts and derivatives
Amikacine, ses sels et dérivés
Amiloride and its salts
Amiloride et ses sels
Aminocaproic acid
Aminocaproïque (acide)
Aminoglutethimide
Aminoglutéhimide
Aminolevulinic acid and its salts and derivatives
Aminolévulinique (acide), ses sels et dérivés
Aminophylline
Aminophylline
Aminopterin and its salts
Aminoptérine et ses sels
4-Amino-pteroyl aspartic acid and its salts
Amino-4-ptéroyl aspartique (acide) et ses sels
5-Aminosalicylic acid
Amino-5-salicylique (acide)
4-Aminosalicylic Acid and its salts
Amino-4 salicylique (acide) et ses sels
Amiodarone and its salts
Amiodarone et ses sels
Amitraz
Amitraz
Amitriptyline and its salts
Amitriptyline et ses sels
Amlexanox and its salts and derivatives
Amlexanox, ses sels et dérivés
Amlodipine and its salts
Amlodipine et ses sels
Ammonium bromide
Bromure d’ammonium
Amoxapine
Amoxapine
Amoxicillin and its salts and derivatives
Amoxicilline, ses sels et dérivés
Amphotericin B and its salts and derivatives
Amphotéricine B, ses sels et dérivés
Ampicillin and its salts and derivatives
Ampicilline, ses sels et dérivés
Amprenavir and its salts and derivatives
Amprénavir et ses sels et dérivés
Amrinone and its salts
Amrinone et ses sels
Amsacrine and its salts
Amsacrine et ses sels
Anagrelide and its salts
Anagrélide et ses sels
Anakinra and its salts and derivatives
Anakinra, ses sels et dérivés
Anastrozole
Anastrozole
Ancestim
Ancestim
Anti-thymocyte globulin
Sérum antithymocytes
Apiol, oil of
Apiol (huile d’)
Apraclonidine and its salts
Apraclonidine et ses sels
Aprotinin
Aprotinine
Argatroban and its salts and derivatives
Argatroban, ses sels et dérivés
L-Asparaginase
L-Asparaginase
Astemizole and its salts
Astémizole et ses sels
Atazanavir and its salts
Atazanavir et ses sels
Atenolol and its salts
Aténolol et ses sels
Atipamezole and its salts
Atipamézole et ses sels
Atorvastatin and its salts
Atorvastatine et ses sels
Atovaquone
Atovaquone
Atracurium besilate
Atracurium (bésilate d’)
Atropine and its salts in ophthalmic or parenteral preparations only
Atropine et ses sels dans les préparations pour usage ophtalmique ou parentéral seulement
Auranofin
Auranofine
Aurothioglucose
Aurothioglucose
Azacyclonol and its salts
Azacyclonol et ses sels
Azaribine
Azaribine
Azathioprine and its salts
Azathioprine et ses sels
Azatidine and its salts
Azatadine et ses sels
Azlocillin and its salts and derivatives
Azlocilline, ses sels et dérivés
Aztreonam and its salts
Aztréonam et ses sels
Baclofen and its salts
Baclofène et ses sels
Bambuterol and its salts
Bambutérol et ses sels
Becaplermin
Bécaplermine
Basiliximab
Basiliximab
Bemegride
Bémégride
Benactyzine and its salts
Benactyzine et ses sels
Benazepril and its salts and derivatives
Bénazépril, ses sels et dérivés
Bendazac and its salts
Bendazac et ses sels
Benoxaprofen and its salts
Benoxaprofène et ses sels
Benserazide and its salts
Bensérazide et ses sels
Benzathine penicillin and its salts and derivatives
Benzathine pénicilline, ses sels et dérivés
Benzoyl peroxide in concentrations greater than 5 per cent or when sold in combination with another medicinal ingredient
Benzoyle (peroxyde de) lorsqu’il constitue plus de cinq pour cent d’un mélange ou qu’il est vendu en association avec un autre ingrédient médicinal
Benztropine and its salts
Benzatropine et ses sels
Benzydamine and its salts
Benzydamine et ses sels
Beractant
Béractant
Betahistine and its salts
Bétahistine et ses sels
Betaine and its salts when sold or recommended for the treatment of homocystinuria
Bétaïne et ses sels s’ils sont vendus ou recommandés pour le traitement de l’homocystinurie
Betaxolol and its salts
Betaxolol et ses sels
Bethanechol chloride
Béthanéchol (chlorure de)
Bethanidine and its salts
Béthanidine et ses sels
Bezafibrate and its salts and derivatives
Bezafibrate, ses sels et dérivés
Bicalutamide
Bicalutamide
Bimatoprost and its derivatives
Bimatoprost et ses dérivés
Biperiden and its salts
Bipéridène et ses sels
Bishydroxycoumarin and its salts and derivatives
Bishydroxycoumarine, ses sels et dérivés
Bisoprolol and its salts
Bisoprolol et ses sels
Bitolterol and its salts
Bitoltérol et ses sels
Bivalirudin
Bivalirudine
Bleomycin
Bléomycine
Bortezomib
Bortézomib
Bosentan and its salts and derivatives
Bosentan et ses sels et dérivés
Botulinum Toxin Type A
Antitoxine botulinique, Type A
Bretylium tosylate
Brétylium (tosylate de)
Brimonidine and its salts
Brimonidine et ses sels
Bromal
Bromal
Bromal hydrate
Bromal (hydrate de)
Brometone
Brométone
Bromisoval
Bromisoval
Bromocriptine and its salts
Bromocriptine et ses sels
Bromoform
Bromoforme
Bumetanide and its salts and derivatives
Bumétanide, ses sels et dérivés
Buproprion and its salts
Buproprione et ses sels
Buserelin and its salts
Buséréline et ses sels
Buspirone and its salts
Buspirone et ses sels
Busulfan
Busulfan
Butaperazine and its salts
Butapérazine et ses sels
Butoconazole and its salts
Butoconazole et ses sels
Butyl chloral hydrate
Butylchloral (hydrate de)
Cabergoline and its salts
Cabergoline et ses sels
Calcipotriol
Calcipotriol
Calcitonin
Calcitonine
Calcitriol
Calcitriol
Calcium bromide
Bromure de calcium
Calcium bromolactobionate
Bromolactobionate de calcium
Calcium carbimide
Calcium (carbimide de)
Candesartan and its salts and derivatives
Candésartan et ses sels et dérivés
Candicidin and its salts and derivatives
Candicidine, ses sels et dérivés
Capecitabine and its salts and derivatives
Capécitabine et ses sels et dérivés
Capreomycin and its salts and derivatives
Capréomycine, ses sels et dérivés
Captodiamine and its salts
Captodiamine et ses sels
Captopril and its salts
Captopril et ses sels
Carbachol
Carbachol
Carbamazepine
Carbamazépine
Carbenicillin and its salts and derivatives
Carbénicilline, ses sels et dérivés
Carbenoxolone and its salts
Carbenoxolone et ses sels
Carbetocin and its salts
Carbétocine et ses sels
Carbidopa and its salts
Carbidopa et ses sels
Carbimazole
Carbimazole
Carbocisteine
Carbocistéine
Carbomycin and its salts and derivatives
Carbomycine, ses sels et dérivés
Carboplatin
Carboplatine
Carbromal
Carbromal
Carisoprodol
Carisoprodol
Carmustine
Carmustine
Carphenazine and its salts
Carphénazine et ses sels
Carprofen and its salts and derivatives
Carprofène, ses sels et dérivés
Carvedilol and its salts
Carvédilol et ses sels
Caspofungin and its salts and derivatives
Caspofungine et ses sels et dérivés
Cefdinir and its salts and derivatives
Cefdinir et ses sels et dérivés
Cefepime and its salts and derivatives
Céfépime, ses sels et dérivés
Cefonicide and its salts
Céfonicide et ses sels
Cefoperazone and its salts and derivatives
Céfopérazone, ses sels et dérivés
Cefprozil and its salts and derivatives
Cefprozil, ses sels et dérivés
Ceftibuten and its salts and derivatives
Ceftibutène, ses sels et dérivés
Celecoxib and its salts
Célécoxib et ses sels
Cephalosporin C and its salts and derivatives
Céphalosporine C, ses sels et dérivés
Cerivastatin and its salts
Cérivastatine et ses sels
Cetirizine and its salts when sold in concentrations greater than 8.5 mg cetirizine per unit dose
Cétirizine et ses sels lorsque vendues en concentration supérieure à 8,5 mg de cétirizine par unité posologique
Cetrorelix and its salts
Cétrorélix et ses sels
Chloral
Chloral
Chloral hydrate
Chloral (hydrate de)
Chloralformamide
Chloralformamide
Chloralimide
Chloralimide
Chlorambucil and its salts and derivatives
Chlorambucil, ses sels et dérivés
Chloramphenicol and its salts and derivatives
Chloramphénicol, ses sels et dérivés
Chlorcyclizine and its salts (except in preparations for external use only)
Chlorcyclizine et ses sels (sauf dans les préparations pour usage externe seulement)
Chlorisondamine and its salts
Chlorisondamine et ses sels
Chlormezanone
Chlormézanone
Chloroquine and its salts
Chloroquine et ses sels
Chlorpropamide
Chlorpropamide
Chlorprothixene and its salts
Chlorprothixène et ses sels
Choline salicylate, when sold in combination with magnesium salicylate
Choline (salicylate de) s’il est vendu en association avec le salicylate de magnésium
Choline theophyllinate
Choline (théophyllinate de)
Ciclopirox and its salts
Ciclopirox et ses sels
Cilastatin and its salts
Cilastatine et ses sels
Cilazapril and its salts and derivatives
Cilazapril, ses sels et dérivés
Cimetidine and its salts, except when sold in concentrations of 200 mg or less per oral dosage unit and indicated for the treatment of heartburn
Cimétidine et ses sels, sauf s’ils sont vendus en une concentration de 200 mg ou moins par unité posologique orale pour le traitement des brûlures d’estomac
Cinchophene and its salts
Cinchophène et ses sels
Cinoxacin
Cinoxacine
Ciprofloxacin and its salts
Ciprofloxacine et ses sels
Cisapride and its salts
Cisapride et ses sels
Cisatracurium besilate
Cisatracurium (bésilate de)
Cisplatin
Cisplatine
Citalopram and its salts
Citalopram et ses sels
Cladribine and its salts
Cladribine et ses sels
Clenbuterol and its salts
Clenbutérol et ses sels
Clindamycin and its salts and derivatives
Clindamycine et ses sels et dérivés
Clodronic acid and its salts
Clodronique (acide) et ses sels
Clofibrate
Clofibrate
Clomiphene and its salts
Clomiphène et ses sels
Clomipramine and its salts
Clomipramine et ses sels
Clonidine and its salts
Clonidine et ses sels
Clopidogrel and its salts
Clopidogrel et ses sels
Cloprostenol and its salts and derivatives
Cloprosténol, ses sels et dérivés
Clorazepic acid and its salts
Clorazépique (acide) et ses sels
Clotrimazole and its salts (except in preparations for topical and vaginal use)
Clotrimazole et ses sels (sauf dans les préparations pour usage topique et vaginal)
Cloxacillin and its salts and derivatives
Cloxacilline, ses sels et dérivés
Clozapine and its salts
Clozapine et ses sels
Colchicine
Colchicine
Colestipol and its salts
Colestipol et ses sels
Colfosceril and its derivatives
Colfoscéril et ses dérivés
Colistin and its salt and derivatives
Colistine, ses sels et dérivés
Cromoglicic acid and its salts (except sodium cromoglicate in solutions for ophthalmic or nasal use in concentrations of 2% or less)
Cromoglicique (acide) et ses sels (sauf le cromoglicate de sodium dans les solutions pour usage ophtalmique ou nasal en concentration de 2 % ou moins)
Cyclobenzaprine and its salts
Cyclobenzaprine et ses sels
Cyclopentolate and its salts in preparations for parenteral or ophthalmic use, except when sold for use in diagnostic procedures to an optometrist registered in a province of Canada
Cyclopentolate et ses sels dans les préparations pour usage parentéral ou ophtalmique, sauf lorsqu’ils sont vendus pour usage diagnostique à un optométriste agréé dans une province du Canada
Cyclophosphamide
Cyclophosphamide
Cycloserine
Cyclosérine
Cyclosporine
Cyclosporine
Cyproterone acetate
Cyprotérone (acétate de)
Cytarabine and its salts
Cytarabine et ses sels
Dacarbazine
Dacarbazine
Daclizumab
Daclizumab
Dactinomycin
Dactinomycine
Dalfopristin and its salts
Dalfopristine et ses sels
Dalteparin and its salts
Daltéparine et ses sels
Danaparoid and its salts and derivatives
Danaparoïde, ses sels et dérivés
Danazol
Danazol
Danofloxacin and its salts
Danofloxacine et ses sels
Dantrolene and its salts
Dantrolène et ses sels
Dapiprazole and its salts
Dapiprazole et ses sels
Daunorubicin and its salts
Daunorubicine et ses sels
Deanol, and its salts and derivatives
Déanol, ses sels et dérivés
Debrisoquin and its salts
Debrisoquine et ses sels
Deferoxamine and its salts
Déféroxamine et ses sels
Delavirdine and its salts
Délavirdine et ses sels
Deserpidine and its alkaloids and salts
Déserpidine, ses alcaloïdes et sels
Desflurane
Desflurane
Desipramine and its salts
Désipramine et ses sels
Desmopressin and its salts
Desmopressin et ses sels
Detomidine and its salts
Détomidine et ses sels
Dexfenfluramine and its salts
Dexfenfluramine et ses sels
Dexrazoxane and its salts
Dexrazoxane et ses sels
Diazoxide and its salts
Diazoxide et ses sels
Dichloroacetic Acid
Dichloroacétique (acide)
Diclofenac and its salts
Diclofénac et ses sels
Dicloxacillin and its salts and derivatives
Dicloxacilline, ses sels et dérivés
Didanosine and its salts and derivatives
Didanosine, ses sels et dérivés
Diethylbromacetamide
Diéthylbromacétamide
Diethylcarbamazine and its salts
Diéthylcarbamazine et ses sels
Diethylstilbestrol and its salts and derivatives
Diéthylstilbestrol, ses sels et dérivés
Difloxacin and its salts and derivatives
Difloxacine et ses sels et dérivés
Diflunisal and its salts
Diflunisal et ses sels
Digitalis lanata and its glycosides
Digitalis lanata et ses glycosides
Digitalis purpurea and its glycosides
Digitalis purpurea et ses glycosides
Digoxin immune Fab (ovine)
Digoxine [Fragments d’anticorps spécifiques de la digoxine Fab (ovins)]
Dihydrotachysterol
Dihydrotachystérol
Diiodohydroxyquin (except in preparations for topical use on the skin)
Diiodohydroxyquinoléine (sauf dans les préparations pour usage topique sur la peau)
Diltiazem and its salts
Diltiazem et ses sels
Dimercaprol
Dimercaprol
Dimethyl sulfoxide
Diméthylsulfoxide
2,4-Dinitrophenol and its salts and derivatives
Dinitro-2,4-phénol, ses sels et dérivés
Dinoprostone and its salts and derivatives
Dinoprostone, ses sels et dérivés
Diphenidol and its salts
Diphénidol et ses sels
Diphenylhydantoin (phenytoin) and its salts
Diphénylhydantoine (phénytoïne) et ses sels
Dipivefrin and its salts
Dipivefrine et ses sels
Diprophylline and its salts
Diprophylline et ses sels
Dipyridamole
Dipyridamole
Disopyramide and its salts
Disopyramide et ses sels
Disulfiram
Disulfirame
Dobutamine and its salts
Dobutamine et ses sels
Docetaxel and its derivatives
Docétaxel et ses dérivés
Dolasetron and its salts
Dolasétron et ses sels
Domperidone
Dompéridone
Donepezil and its salts
Donépézil et ses sels
Dopamine and its salts
Dopamine et ses sels
Dornase alfa
Dornase alfa
Dorzolamide and its salts
Dorzolamide et ses sels
Doxacurium chloride
Doxacurium (cholure de)
Doxapram
Doxapram
Doxazosin and its salts
Doxazosine et ses sels
Doxepin and its salts
Doxépine et ses sels
Doxercalciferol and its derivatives
Doxercalciférol et ses dérivés
Doxorubicin and its salts
Doxorubicine et ses sels
Doxycycline and its salts and derivatives, when sold for intramuscular administration in caged birds
Doxycycline, ses sels et dérivés, lorsque vendue pour administration intramusculaire aux oiseaux en cage
Doxylamine and its salts, when sold or recommended for use in the nausea or vomiting of pregnancy
Doxylamine et ses sels lorsque vendus ou recommandés contre les nausées ou vomissements de la grossesse
Droperidol and its salts
Dropéridol et ses sels
Drotrecogin
Drotrécogine
Dutasteride
Dutastéride
Econazole and its salts
Éconazole et ses sels
Ecothiophate and its salts
Écothiophate et ses sels
Ectylurea and its salts
Ectylurée et ses sels
Edrophonium chloride
Édrophonium (chlorure d’)
Efavirenz
Éfavirenz
Eflornithine and its salts and derivatives
Éflornithine, ses sels et dérivés
Embutramide
Embutramide
Emedastine and its salts
Émédastine et ses sels
Emylcamate
Émylcamate
Enalaprilat and its salts and derivatives
Énalaprilate, ses sels et dérivés
Enflurane
Enflurane
Enfuvirtide
Enfuvirtide
Enoxaparin and its salts
Énoxaparine et ses sels
Enrofloxacin
Enrofloxacine
Entacapone
Entacapone
Epirubicine and its salts
Épirubicine et ses sels
Epoprostenol and its salts
Époprosténol et ses sels
Eprosartan and its salts and derivatives
Éprosartan et ses sels et dérivés
Epsiprantel
Epsiprantel
Eptifibatide and its salts
Eptifibatide et ses sels
Ertapenem and its salts
Ertapénem et ses sels
Erythropoietin
Érythropoiétine
Esmolol and its salts
Esmolol et ses sels
Esomeprazole and its salts
Ésoméprazole et ses sels
Estramustine and its salts
Estramustine et ses sels
Etanercept
Étanercept
Ethacrynic acid
Étacrynique (acide)
Ethambutol and its salts
Éthambutol et ses sels
Ethionamide and its salts
Éthionamide et ses sels
Ethomoxane and its salts
Éthomoxane et ses sels
Ethotoin and its salts
Éthotoine et ses sels
Ethyl trichloramate
Éthyle (trichloramate d’)
Etidronic acid and its salts
Étidronique (acide) et ses sels
Etodolac and its salts and derivatives
Étodolac, ses sels et dérivés
Etoposide and its derivatives
Étoposide et ses dérivés
Etretinate
Étrétinate
Etymemazine and its salts
Étymémazine et ses sels
Exemestane
Exémestane
Ezetimibe
Ézétimibe
Famciclovir and its salts
Famciclovir et ses sels
Famotidine and its salts (except in preparations for oral use containing 10 mg or less of famotidine per dosage unit)
Famotidine et ses sels (sauf dans les préparations pour usage oral contenant 10 mg ou moins de famotidine par unité posologique)
Felodipine and its salts
Félodipine et ses sels
Fenfluramine and its salts
Fenfluramine et ses sels
Fenofibrate
Fénofibrate
Fenoprofen and its salts
Fénoprofène et ses sels
Fenoterol and its salts
Fénotérol et ses sels
Filgrastim
Filgrastime
Finasteride
Finastéride
Flavoxate and its salts
Flavoxate et ses sels
Flecainide and its salts
Flécaïnide et ses sels
Fleroxacin and its salts and derivatives
Fléroxacine, ses sels et dérivés
Floctafenine
Floctafénine
Florfenicol and its derivatives
Florfénicol et ses dérivés
Fluconazole
Fluconazole
Flucytosine
Flucytosine
Fludarabine and its salts and derivatives
Fludarabine, ses sels et dérivés
Flunarizine and its salts
Flunarizine et ses sels
Flunixin and its salts and derivatives
Flunixine, ses sels et dérivés
Fluorouracil and its derivatives
Fluorouracile et ses dérivés
Fluoxetine and its salts
Fluoxétine et ses sels
Flupentixol and its salts and derivatives
Flupentixol, ses sels et dérivés
Fluphenazine and its salts
Fluphénazine et ses sels
Fluprostenol and its salts and derivatives
Fluprosténol, ses sels et dérivés
Flurbiprofen and its salts
Flurbiprofène et ses sels
Fluspirilene
Fluspirilène
Flutamide
Flutamide
Fluvastatin and its salts and derivatives
Fluvastatine, ses sels et dérivés
Fluvoxamine and its salts
Fluvoxamine et ses sels
Folic acid in oral dosage form containing more than 1.0 mg of folic acid per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 1.0 mg of folic acid
Acide folique présenté en unités posologiques orales contenant chacune plus de 1,0 mg d’acide folique ou dont la plus forte dose quotidienne recommandée sur l’étiquette résulte en l’ingestion, par une personne, de plus de 1,0 mg d’acide folique
Follicle stimulating hormone
Folliculo-stimulante (hormone)
Fomepizole and its salts
Fomépizole et ses sels
Fondaparinux sodium
Fondaparinux sodique
Formestane and its derivatives
Formestane et ses dérivés
Formoterol and its salts
Formotérol et ses sels
Foscarnet sodium
Foscarnet sodique
Fosfomycin and its salts
Fosfomycine et ses sels
Fosinopril and its salts
Fosinopril et ses sels
Fosphenytoin and its salts
Fosphénytoïne et ses sels
Fulvestrant
Fulvestrant
Fusidic acid and its salts
Fusidique (acide) et ses sels
Gabapentin and its salts and derivatives
Gabapentin, ses sels et dérivés
Galantamine and its salts and derivatives
Galantamine et ses sels et dérivés
Gallamine triethiodide
Gallamine (triéthiodure de)
Gallium and its salts
Gallium et ses sels
Ganciclovir and its salts
Ganciclovir et ses sels
Ganirelix and its salts and derivatives
Ganirélix, ses sels et dérivés
Gatifloxacin and its salts and derivatives
Gatifloxacine, ses sels et dérivés
Gefitinib
Géfitinib
Gemcitabine and its salts
Gemcitabine et ses sels
Gemfibrozil and its salts
Gemfibrozil et ses sels
Gemifloxacin and its salts
Gémifloxacine et ses sels
Gentamicin and its salts and derivatives
Gentamicine, ses sels et dérivés
Glatiramer and its salts
Glatiramère et ses sels
Gliclazide
Gliclazide
Glimepiride
Glimépiride
Glipizide
Glipizide
Glyburide and its salts and derivatives
Glyburide, ses sels et dérivés
Gold and its salts
Or et ses sels
Gonadorelin and its salts
Gonadoréline et ses sels
Gonadotropin, chorionic (human)
Gonadotropine chorionique (humain)
Gonadotropins, serum (human)
Gonadotropines sériques (humains)
Goserelin and its salts
Goséréline et ses sels
Granisetron and its salts
Granisetron et ses sels
Grepafloxacin and its salts and derivatives
Grépafloxacine et ses sels et dérivés
Guanethidine and its salts
Guanéthidine et ses sels
Halofantrine and its salts
Halofantrine et ses sels
Haloperidol
Halopéridol
Halothane
Halothane
Hetacillin and its salts and derivatives
Hétacilline, ses sels et dérivés
Hetastarch and its derivatives
Hetastarch et ses dérivés
Hexachlorophene and its salts
Hexachlorophène et ses sels
Hexacyclonate sodium
Hexacyclonate sodique
Hexamethonium and its salts
Hexaméthonium et ses sels
Hyaluronic acid and its salts, when sold or recommended for administration by intra-articular injection to horses
Hyaluronique (acide) et ses sels, s’il est vendu ou recommandé pour administration par injection intra-articulaire aux chevaux
Hydralazine and its salts
Hydralazine et ses sels
Hydroxychloroquine and its salts
Hydroxychloroquine et ses sels
4-Hydroxycoumarin and its derivatives when sold or recommended as anticoagulants
Hydroxy-4 coumarine et ses dérivés, s’ils sont vendus ou recommandés comme anticoagulants
Hydroxyurea
Hydroxyurée
Hydroxyzine and its salts and derivatives
Hydroxyzine, ses sels et dérivés
Ibandronic acid and its salts
Acide ibandronique et ses sels
Ibuprofen and its salts except when sold for oral administration in a concentration of 400 mg or less per dosage unit.
Ibuprofène et ses sels, sauf s’ils sont vendus pour administration par voie orale en une concentration de 400 mg ou moins par unité posologique
Ibutilide and its salts and derivatives
Ibutilide et ses sels et dérivés
Idarubicin and its salts
Idarubicine et ses sels
Idoxuridine
Idoxuridine
Ifosfamide
Ifosfamide
Imatinib and its salts
Imatinib et ses sels
Imiglucerase
Imiglucérase
Imipenem and its salts and derivatives
Imipénem, ses sels et dérivés
Imipramine and its salts
Imipramine et ses sels
Imiquimod and its salts
Imiquimod et ses sels
Indapamide and its salts
Indapamide et ses sels
Indinavir and its salts
Indinavir et ses sels
Indomethacin
Indométhacine
Infliximab
Infliximab
Inosiplex
Inosiplex
Interferon
Interféron
Iodochlorohydroxyquin (except in preparations for topical use on the skin)
Iodochlorhydroxyquinoléine (sauf dans les préparations pour usage topique sur la peau)
Ipratropium and its salts
Ipratropium et ses sels
Iproniazid and its salts
Iproniazide et ses sels
Irbesartan and its salts
Irbésartan et ses sels
Irinotecan and its salts
Irinotécan et ses sels
Isocarboxazid and its salts
Isocarboxazide et ses sels
Isoflurane
Isoflurane
Isoniazid
Isoniazide
Isoproterenol (Isoprenaline) and its salts
Isoprotérénol (Isoprénaline) et ses sels
Isotretinoin and its salts
Isotrétinoïne et ses sels
Isoxsuprine and its salts
Isoxsuprine et ses sels
Isradipine and its salts
Isradipine et ses sels
Itraconazole and its salts
Itraconazole et ses sels
Ivermectin and its derivatives, for human use or for veterinary use when sold for intramuscular injection into horses or for oral administration to dogs and cats
Ivermectine et ses dérivés, destinés à l'usage humain ou à l'usage vétérinaire, s'ils sont vendus pour injection intramusculaire aux chevaux ou pour administration par voie orale aux chiens et aux chats
Ketanserin and its salts
Kétansérine et ses sels
Ketoconazole and its salts (except in preparations for topical use as a shampoo)
Kétoconazole et ses sels (excepté pour les préparations pour usage topique sous la forme d’un shampooing)
Ketoprofene and its salts
Kétoprofène et ses sels
Ketorolac and its salts
Kétorolac et ses sels
Ketotifen and its salts
Kétotifène et ses sels
Labetalol and its salts
Labétalol et ses sels
Lactic acid, when recommended for parenteral use as a tissue sclerosing agent
Acide lactique, s’il est recommandé pour usage parentéral comme agent sclérosant
Lamivudine and its salts
Lamivudine et ses sels
Lamotrigine and its salts
Lamotrigue et ses sels
Lansoprazole and its salts
Lansoprazole et ses sels
Latanoprost
Latanoprost
Leflunomide and its salts
Léflunomide et ses sels
Letrozole
Létrozole
Leucovorin and its salts
Acide folinique et ses sels
Leuprolide and its salts
Leuproréline et ses sels
Levetiracetam
Lévétiracétam
Levobunolol and its salts
Levobunolol et ses sels
Levocabastine and its salts and derivatives
Lévocabastine, ses sels et dérivés
Levocarnitine and its salts and derivatives
Lévocarnitine et ses sels et dérivés
Levodopa and its salts
Lévodopa et ses sels
Linezolid and its salts
Linézolide et ses sels
Lisinopril and its salts and derivatives
Lisinopril, ses sels et dérivés
Lithium and its salts
Lithium et ses sels
Lodoxamide and its salts and derivatives
Lodoxamide, ses sels et dérivés
Lomefloxacin and its salts
Loméfloxacine et ses sels
Lomustine
Lomustine
Lopinavir
Lopinavir
Loracarbef and its salts and derivatives
Loracarbef, ses sels et dérives
Losartan and its salts
Losartan et ses sels
Losoxantrone and its salts
Losoxantrone et ses sels
Lovastatin
Lovastatine
Loxapine and its salts
Loxapine et ses sels
Magnesium glutamate hydrobromide
Bromhydrate de glutamate de magnésium
Maprotiline and its salts
Maprotiline et ses sels
Marbofloxacin and its salts and derivatives
Marbofloxacine et ses sels et dérivés
Mecamylamine and its salts
Mécamylamine et ses sels
Mechlorethamine and its salts
Méchloréthamine et ses sels
Mecillinam and its salts and derivatives
Mécillinam, ses sels et dérivés
Meclofenamic acid and its salts
Méclofénamique (acide) et ses sels
Medetomidine and its salts
Médétomidine et ses sels
Mefenamic acid and its salts
Méfénamique (acide) et ses sels
Mefloquine and its salts and derivatives
Méfloquine, ses sels et dérivés
Megestrol and its salts
Mégestrol et ses sels
Melanoma therapeutic vaccine
Vaccin thérapeutique contre le mélanome
Melarsomine and its salts, when sold for the treatment of heartworm in dogs
Mélarsomine et ses sels, s'ils sont vendus pour le traitement du ver du coeur chez le chien
Meloxicam and its salts and derivatives
Méloxicam et ses sels et dérivés
Melphalan
Melphalan
Memantine and its salts
Mémantine et ses sels
Menotropins (human)
Ménotropines (humains)
Mepacrine and its salts
Mépacrine et ses sels
Mepazine and its salts
Mépazine et ses sels
Mephenoxalone
Méphenoxalone
Mephentermine and its salts
Méphentermine et ses sels
Mercaptopurine
Mercaptopurine
Meropenem and its salts and derivatives
Méropénem, ses sels et dérivés
Mesna
Mesna
Mesoridazine and its salts
Mésoridazine et ses sels
Metaldehyde
Métaldéhyde
Metformin and its salts and derivatives
Metformine, ses sels et dérivés
Methacholine chloride
Méthacholine (chlorure de)
Methazolamide and its salts
Méthazolamide et ses sels
Methicillin and its salts and derivatives
Méthicilline, ses sels et dérivés
Methimazole
Méthimazole
Methisazone
Méthisazone
Methoin (Mephenytoin) and its salts
Méthoïne (méphénytoine) et ses sels
Methotrexate and its salts
Méthotrexate et ses sels
Methotrimeprazine and its salts
Méthotriméprazine et ses sels
Methoxamine and its salts
Méthoxamine et ses sels
Methoxsalen
Méthoxsalène
Methyldopa and its salts
Méthyldopa et ses sels
Methylparafynol
Méthylparafynol
Methysergide and its salts and derivatives
Méthysergide, ses sels et dérivés
Metoclopramide
Métoclopramide
Metolazone and its salts
Métolazone et ses sels
Metomidate and its salts
Métomidate et ses sels
Metopimazine and its salts
Métopimazine et ses sels
Metoprolol and its salts
Métoprolol et ses sels
Metronidazole
Métronïdazole
Metyrapone and its salts
Métyrapone et ses sels
Mexiletine and its salts
Mésiletine et ses sels
Mezlocillin and its salts and derivatives
Mézlocilline, ses sels et dérivés
Miconazole and its salts (except in preparations for topical and vaginal use)
Miconazole et ses sels (sauf dans les préparations pour usage topique et vaginal)
Midodrine and its salts
Midodrine et ses sels
Milbemycin and its derivatives
Milbémycine et ses dérivés
Milrinone and its salts
Milrinone et ses sels
Minoxidil (except in solutions for topical use in concentrations of 2% or less)
Minoxidil (sauf dans les solutions pour usage topique où sa concentration est de 2 % ou moins)
Mirtazapine and its salts
Mirtazapine et ses sels
Mitomycin and its salts
Mitomycine et ses sels
Mitotane (o,p’-DDD)
Mitotane (o,p’-DDD)
Mitoxantrone and its salts
Mitoxantrone et ses sels
Mivacurium chloride
Mivacurium (chlorure de)
Modafinil and its salts
Modafinil et ses sels
Molgramostim
Molgramostim
Montelukast and its salts
Montélukast et ses sels
Moxidectin and its derivatives, when sold for the prevention of heartworm in dogs
Moxidectine et ses dérivés, s'ils sont vendus pour la prévention du ver du coeur chez le chien
Moxifloxacin and its salts and derivatives
Moxifloxacine, ses sels et dérivés
Mycophenolic acid and its salts and derivatives
Mycophénolique (acide) et ses sels et dérivés
Nabumetone
Nabumétone
Nadolol and its salts
Nadolol et ses sels
Nadroparin and its salts
Nadroparine et ses sels
Nafarelin and its salts and derivatives
Nafaréline, ses sels et dérivés
Nafcillin and its salts and derivatives
Nafcilline, ses sels et dérivés
Nalidixic acid
Nalidixique (acide)
Nalmefene and its salts
Nalméfène et ses sels
Naloxone and its salts
Naloxone et ses sels
Naltrexone and its salts
Naltrexone et ses sels
Naproxen and its salts
Naproxène et ses sels
Naratriptan and its salts
Naratriptan et ses sels
Nateglinide and its salts and derivatives
Natéglinide et ses sels et dérivés
Nedocromil and its salts
Nédocromil et ses sels
Nefazodone and its salts
Néfazodone et ses sels
Nelfinavir and its salts
Nelfinavir et ses sels
Neocinchophen and its salts
Néocinchophène et ses sels
Neostigmine salts
Néostigmine (les sels de)
Netilmicin and its salts and derivatives
Nétilmicine, ses sels et dérivés
Nevirapine and its salts
Névirapine et ses sels
Nialamide and its salts
Nialamide et ses sels
Nicardipine and its salts
Nicardipine et ses sels
Nicotine and its salts, for human use, except
(a) in natural substances;
(b) in the form of a chewing gum containing 4 mg or less of nicotine per dosage unit;
(c) in the form of a transdermal patch with a delivery rate of 22 mg or less of nicotine per day;
(d) in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit; or
(e) in the form of a lozenge containing 4 mg or less of nicotine per dosage unit
Nicotine et ses sels, destinés à l’usage humain, sauf :
a) dans les substances naturelles;
b) sous forme de gomme à mâcher contenant 4 mg ou moins de nicotine par unité posologique;
c) sous forme de timbre cutané ayant un taux de libération de 22 mg ou moins de nicotine par jour;
d) sous une forme destinée à être administrée par voie orale au moyen d’un inhalateur libérant 4 mg ou moins de nicotine par unité posologique;
e) sous forme de pastille contenant 4 mg ou moins de nicotine par unité posologique
Nifedipine
Nifédipine
Nilutamide
Nilutamide
Nimodipine and its salts
Nimodipine et ses sels
Nitroscanate
Nitroscanate
Nizatidine and its salts (except when sold in an oral dosage form containing not more than the equivalent of 75 mg of nizatidine)
Nizatidine et ses sels (sauf lorsque vendue sous une forme posologique orale contenant au plus l’équivalent de 75 mg de nizatidine)
Nomifensine and its salts
Nomifensine et ses sels
Norfloxacin
Norfloxacine
Nortriptyline and its salts
Nortriptyline et ses sels
Nylidrin and its salts
Nylidrine et ses sels
Octatropine methylbromide
Octatropine (méthylbromure d’)
Octreotide
Octréotide
Ofloxacin and its salts
Ofloxacine et ses sels
Olanzapine and its salts
Olanzapine et ses sels
Olopatadine and its salts
Olopatadine et ses sels
Olsalazine and its salts
Olsalazine et ses sels
Omeprazole and its salts
Oméprazole et ses sels
Ondansetron and its salts
Ondansétron et ses sels
Orbifloxacin and its salts and derivatives
Orbifloxacine, ses sels et dérivés
Orciprenaline (Metaproterenol) and its salts
Orciprénaline (Métaprotérénol) et ses sels
Orlistat
Orlistat
Ormetoprim and its salts
Ormétoprime et ses sels
Ornidazole
Ornidazole
Oseltamivir and its salts
Oséltamivir et ses sels
Oxacillin, and its salts and derivatives
Oxacilline, ses sels et dérivés
Oxanamide
Oxanamide
Oxaprozin and its salts and derivatives
Oxaprozine, ses sels et dérivés
Oxcarbazepine
Oxcarbazépine
Oxolinic acid and its salts
Oxolinique (acide) et ses sels
Oxprenolol and its salts
Oxprénolol et ses sels
Oxybutynin and its salts
Oxybutynine et ses sels
Oxyphenbutazone and its salts
Oxyphenbutazone et ses sels
Oxytocin
Oxytocine
Paclitaxel and its derivatives
Paclitaxel et ses dérivés
Palivizumab
Palivizumab
Pamidronic acid and its salts
Pamidronique (acide) et ses sels
Pancuronium and its salts
Pancuronium et ses sels
Pantoprazole and its salts
Pantoprazole et ses sels
Paraldehyde
Paraldéhyde
Paramethadione
Paraméthadione
Pargyline and its salts
Pargyline et ses sels
Paroxetine and its salts
Paroxétine et ses sels
Penciclovir and its salts
Penciclovir et ses sels
Penicillamine
Pénicillamine
Pentamidine and its salts
Pentamidine et ses sels
Pentolinium tartrate
Pentolinium (tartrate de)
Pentosan polysulfate and its salts
Pentosane polysulfate et ses sels
Pentostatin and its salts
Pentostatine et ses sels
Pentoxifylline and its salts
Pentoxifylline et ses sels
Perflutren
Perflutrène
Pergolide and its salts
Pergolide et ses sels
Pericyazine and its salts
Péricyazine et ses sels
Perindopril and its salts
Périndopril et ses sels
Perphenazine and its salts
Perphénazine et ses sels
Phacetoperane and its salts
Phacétopérane et ses sels
Phenacemide
Phénacémide
Phenacetin
Phénacétine
Phenaglycodol
Phénaglycodol
Phenazopyridine and its salts
Phénazopyridine et ses sels
Phenelzine and its salts
Phénelzine et ses sels
Phenformin and its salts
Phenformine et ses sels
Pheniprazine and its salts
Phéniprazine et ses sels
Phenthoxate and its salts
Phentoxate et ses sels
Phentolamine and its salts
Phentolamine et ses sels
Phenylbutazone and its salts
Phénylbutazone et ses sels
Phenylephrine and its salts in preparations for ophthalmic or parenteral use in concentrations greater than 2.5%
Phényléphrine et ses sels dans les préparations pour usage ophtalmique ou parentéral lorsqu’il constitue plus de 2,5% d’un mélange
Phenylindanedione and its derivatives
Phénylindanédione et ses dérivés
Phenylpropanolamine and its salts and derivatives for veterinary use
Phénylpropanolamine, ses sels et dérivés, destinés à l'usage vétérinaire
Pilocarpine and its salts
Pilocarpine et ses sels
Pimecrolimus
Pimécrolimus
Pimozide
Pimozide
Pinaverium bromide
Pinavérium (bromure de)
Pindolol and its salts
Pindolol et ses sels
Pioglitazone and its salts
Pioglitazone et ses sels
Pipecuronium bromide
Pipécuronium (bromure de)
Piperacetazine and its salts
Pipéracétazine et ses sels
Piperilate and its salts
Pipérilate et ses sels
Pipotiazine and its salts
Pipotiazine et ses sels
Pipobroman
Pipobroman
Pirbuterol and its salts
Pirbutérol et ses sels
Pirenzepine and its salts
Pirenzépine et ses sels
Piroxicam and its salts
Piroxicam et ses sels
Pizotyline and its salts
Pizotyline et ses sels
Podophyllum and the following extracts and active principles, when sold or recommended for topical use:
(a) podophyllotoxin
(b) podophyllum resin
Podophyllum, ses extraits et principes actifs suivants lorsque vendus ou recommandés pour usage topique :
a) podophyllotoxine
b) podophyllum (résine de)
Polysulfated glycosaminoglycan
Glycosaminoglycan polysulfaté
Ponazuril
Ponazuril
Poractant alfa
Poractant alfa
Porfimer and its salts
Porfimère et ses sels
Potassium bromide
Bromure de potassium
Potassium gluconate, when sold or recommended for administration to cats
Potassium (gluconate de), lorsqu’il est vendu ou recommandé pour administration aux chats
Potassium para-aminobenzoate (except in preparations for topical use on the skin)
Potassium (para-aminobenzoate de) (sauf dans les préparations pour usage topique sur la peau)
Pralidoxime and its salts
Pralidoxime et ses sels
Pramipexole and its salts
Pramipexole et ses sels
Pravastatin and its salts
Pravastatine et ses sels
Praziquantel, except when sold for the treatment of the tapeworm Anoplocephala perfoliata in horses
Praziquantel, sauf s'il est vendu pour le traitement du ver solitaire Anoplocephala perfoliata chez les chevaux
Prazosin and its salts
Prazosine et ses sels
Prenylamine and its salts
Prénylamine et ses sels
Primaquine and its salts
Primaquine et ses sels
Probenecid and its salts
Probénécide et ses sels
Probucol
Probucol
Procainamide and its salts
Procainamide et ses sels
Procarbazine and its salts
Procarbazine et ses sels
Procaterol and its salts
Procatérol et ses sels
Prochlorperazine and its salts
Prochlorpérazine et ses sels
Procyclidine and its salts
Procyclidine et ses sels
Prodilidine and its salts
Prodilidine et ses sels
Profenamine and its salts
Profénamine et ses sels
Proguanil and its salts
Proguanil et ses sels
Propafenone and its salts
Propafénone et ses sels
Propofol
Propofol
Propranolol and its salts
Propranolol et ses sels
Prostaglandins and their salts and derivatives
Prostaglandines, leurs sels et dérivés
Prothipendyl hydrochloride
Prothipendyl (chlorhydrate de)
Protirelin
Protireline
Protriptyline and its salts
Protriptyline et ses sels
Pyrazinamide
Pyrazinamide
Pyridostigmine bromide
Pyridostigmine (bromure de)
Pyrimethamine and its salts
Pyriméthamine et ses sels
Quetiapine and its salts
Quétiapine et ses sels
Quinagolide and its salts
Quinagolide et ses sels
Quinapril and its salts and derivatives
Quinapril, ses sels et dérivés
Quinupristin and its salts
Quinupristine et ses sels
Rabeprazole and its salts
Rabéprazole et ses sels
Raloxifene and its salts
Raloxifène et ses sels
Raltitrexed and its salts and derivatives
Raltitrexed, ses sels et dérivés
Ramipril and its salts and derivatives
Ramipril, ses sels et dérivés
Ranitidine and its salts (except when sold in a dosage form containing not more than the equivalent of 75 mg of ranitidine)
Ranitidine et ses sels (sauf lorsque vendue sous une forme posologique contenant au plus l’équivalent de 75 mg de ranitidine
Raubasine and its salts
Raubasine et ses sels
Rauwolfia
Rauwolfia
Remoxipride and its salts
Rémoxipride et ses sels
Repaglinide and its salts and derivatives
Répaglinide et ses sels et dérivés
Rescinnamine and its salts
Rescinnamine et ses sels
Reviparin and its salts
Réviparine et ses sels
Ribavirin
Ribavirine
Rifabutin and its salts
Rifabutine et ses sels
Rifampin and its salts and derivatives
Rifampine, ses sels et dérivés
Riluzole and its salts
Riluzole et ses sels
Risedronic acid and its salts
Acide risédronique et ses sels
Risperidone and its salts
Rispéridone et ses sels
Ritodrine and its salts
Ritodrine et ses sels
Ritonavir
Ritonavir
Rituximab
Rituximab
Rivastigmine and its salts
Rivastigmine et ses sels
Rizatriptan and its salts
Rizatriptan et ses sels
Rocuronium bromide
Rocuronium (bromure de)
Rofecoxib
Rofécoxib
Romifidine and its salts
Romifidine et ses sels
Ropinirole and its salts
Ropinirole et ses sels
Rosiglitazone and its salts
Rosiglitazone et ses sels
Rosoxacin and its salts
Rosoxacine et ses sels
Rosuvastatin and its salts
Rosuvastatine et ses sels
Salbutamol and its salts
Salbutamol et ses sels
Salmeterol and its salts
Salmetérol et ses sels
Salsalate and its salts and derivatives
Salsalate, ses sels et dérivés
Saquinavir and its salts and derivatives
Saquinavir, ses sels et dérivés
Saralasin and its salts
Saralasine et ses sels
Sargramostim
Sargramostim
Selegiline and its salts
Sélégiline et ses sels
Sermorelin and its salts
Sermoréline et ses sels
Sertraline and its salts
Sertraline et ses sels
Sevelamer and its salts
Sévélamer et ses sels
Sibutramine and its salts
Sibutramine et ses sels
Sildenafil and its salts
Sildénafil et ses sels
Simvastatin
Simvastatine
Sirolimus and its derivatives
Sirolimus et ses dérivés
Sodium aurothiomalate
Aurothiomalate de sodium
Sodium bromide
Bromure de sodium
Sodium nitroprusside and its salts
Sodium (nitroprussiate de) et ses sels
Sodium polystyrene sulfonate
Sulfonate de polystyrène de sodium
Somatostatin
Somatostatine
Somatrem
Somatrem
Somatropin
Somatropine
Sotalol and its salts
Sotalol et ses sels
Spironolactone
Spironolactone
Stavudine
Stavudine
Streptozocin
Streptozocine
Strontium bromide
Bromure de strontium
Succinimide and its salts and derivatives (except those compounds used for decontaminating water)
Succinimide, ses sels et dérivés (sauf les produits utilisés pour décontaminer l’eau)
Sucralfate
Sucralfate
Sulconazole and its salts
Sulconazole et ses sels
Sulfinpyrazone and its salts
Sulfinpyrazone et ses sels
Sulindac and its salts
Sulindac et ses sels
Sulphones and their derivatives
Sulphones et leurs dérivés
Sumatriptan and its salts
Sumatriptan et ses sels
Suprofen and its salts
Suprofène et ses sels
Suxamethonium chloride
Suxaméthonium (chlorure de)
Tacrolimus and its derivatives
Tacrolimus et ses dérivés
Tadalafil and its salts
Tadalafil et ses sels
Tamoxifen and its salts
Tamoxifène et ses sels
Tamsulosin and its salts
Tamsulosine et ses sels
Tazarotene
Tazarotène
Tazobactam and its salts and derivatives
Tazobactam, ses sels et dérivés
Teflubenzuron
Teflubenzuron
Tegafur and its salts
Tégafur et ses sels
Tegaserod and its salts
Tégasérod et ses sels
Telithromycin and its salts and derivatives
Télithromycine et ses sels et dérivés
Telmisartan and its salts and derivatives
Telmisartan et ses sels et dérivés
Temozolomide and its salts
Témozolomide et ses sels
Tenecteplase and its salts and derivatives
Ténectéplase et ses sels et dérivés
Teniposide
Téniposide
Tenofovir and its salts and derivatives
Ténofovir et ses sels et dérivés
Tenoxicam and its salts
Ténoxicam et ses sels
Terazosin and its salts
Térazosine et ses sels
Terbinafine and its salts
Terbinafine et ses sels
Terbutaline and its salts
Terbutaline et ses sels
Terconazole and its salts
Terconazole et ses sels
Terfenadine and its salts
Terfénadine et ses sels
Terlipressin and its salts
Terlipressine et ses sels
Tetrabenazine and its salts
Tétrabénazine et ses sels
Thalidomide
Thalidomide
Theobromine and its salts
Théobromine et ses sels
Theophylline and its salts
Théophylline et ses sels
Thiethylperazine and its salts
Thiéthylpérazine et ses sels
Thiocarlide
Thiocarlide
Thioguanine
Thioguanine
Thiopropazate and its salts
Thiopropazate et ses sels
Thioproperazine and its salts
Thiopropérazine et ses sels
Thioridazine and its salts
Thioridazine et ses sels
Thiotepa
Thiotépa
Thiothixene and its salts
Thiothixène et ses sels
Thiouracil and its derivatives
Thiouracile et ses dérivés
Thyrotropin alfa
Thyrotropine alfa
Thyroxin and its salts
Thyroxine et ses sels
Tiaprofenic acid and its salts
Tiaprofénique (acide) et ses sels
Ticarcillin and its salts and derivatives
Ticarcilline, ses sels et dérivés
Ticlopidine and its salts
Ticlopidine et ses sels
Tilmicosin, except in preparations for veterinary use to be administered orally
Tilmicosine, sauf dans les préparations pour usage vétérinaire destinées à être administrées par voie orale
Tiludronic acid and its salts
Tiludronique (acide) et ses sels
Timolol and its salts
Timolol et ses sels
Tinidazole
Tinidazole
Tinzaparin and its salts
Tinzaparine et ses sels
Tioconazole and its salts (except in preparations for topical and vaginal use)
Tioconazole et ses sels (sauf dans les préparations pour usage topique et vaginal)
Tiotropium bromide
Tiotropium (bromure de)
Tirofiban and its salts and derivatives
Tirofiban et ses sels et dérivés
Tizanidine and its salts
Tizanidine et ses sels
Tobramycin and its salts and derivatives
Tobramycine, ses sels et dérivés
Tocainide and its salts
Tocaïnide et ses sels
Tolazamide
Tolazamide
Tolazoline and its salts
Tolazoline et ses sels
Tolbutamide
Tolbutamide
Tolcapone
Tolcapone
Tolfenamic acid and its salts and derivatives
Tolfénamique (acide), ses sels et dérivés
Tolmetin and its salts
Tolmétine et ses sels
Tolterodine and its salts
Toltérodine et ses sels
Topiramate
Topiramate
Topotecan and its salts
Topotécane et ses sels
Torasemide and its salts
Torasémide et ses sels
Toremifene and its salts
Torémifène et ses sels
Trandolaprilat and its salts and derivatives
Trandolaprilat et ses sels et dérivés
Tranexamic acid
Tranexamique (acide)
Tranylcypromine
Tranylcypromine
Trastuzumab
Trastuzumab
Trazodone and its salts
Trazodone et ses sels
Treosulfan
Tréosulfan
Treprostinil and its salts
Tréprostinil et ses sels
Tretamine
Trétamine
Tretinoin and its salts and derivatives
Trétinoïne, ses sels et dérivés
Tretinoin (Vitamin A acid)
Trétinoïne (acide de vitamine A)
Triamterene and its salts
Triamtérène et ses sels
Tricaine and its salts
Tricaïne et ses sels
Trifluoperazine and its salts
Trifluopérazine et ses sels
Triflupromazine and its salts
Triflupromazine et ses sels
Trifluridine
Trifluridine
Trihexyphenidyl and its salts
Trihexyphénidyle et ses sels
Triiodothyropropionic acid
Triiodothyropropionique (acide)
Trilostane
Trilostane
Trimebutine and its salts
Trimébutine et ses sels
Trimethadione
Triméthadione
Trimethaphan camsylate
Trimétaphan (camsilate de)
Trimethoprim and its salts
Triméthoprime et ses sels
Trimetrexate and its salts
Trimétrexate et ses sels
Trimipramine and its salts
Trimipramine et ses sels
Trioxsalen
Trioxysalène
Troglitazone
Troglitazone
Tropicamide and its salts in preparations for parenteral or ophthalmic use, except when sold for use in diagnostic procedures to an optometrist registered in a province of Canada
Tropicamide et ses sels dans les préparations pour usage ophtalmique ou parentéral, sauf lorsque vendu pour usage diagnostique à un optométriste enregistré dans une province du Canada
Trovafloxacin and its salts and derivatives
Trovafloxacine et ses sels et dérivés
L-Tryptophan, when sold as a single ingredient
L-Tryptophane, s’il est vendu comme seul ingrédient
Tubocurarine chloride
Tubocurarine (chlorure de)
Tybamate
Tybamate
Tylosin and its salts and derivatives, when sold for the treatment of chronic colitis in dogs
Tylosine, ses sels et dérivés, lorsque vendu pour le traitement de la colite chronique chez le chien
Unoprostone and its salts and derivatives
Unoprostone, ses sels et dérivés
Uracil and its salts
Uracile et ses sels
Uracil mustard and its salts
Uracile (moutarde à l’) et ses sels
Ursodeoxycholic acid and its salts
Ursodéoxycholique (acide) et ses sels
Valaciclovir and its salts
Valaciclovir et ses sels
Valdecoxib and its salts
Valdécoxib et ses sels
Valganciclovir and its salts and derivatives
Valganciclovir, ses sels et dérivés
Valproic acid and its salts
Valproïque (acide) et ses sels
Valrubicin and its derivatives
Valrubicine et ses dérivés
Valsartan and its salts and derivatives
Valsartan et ses sels et dérivés
Vancomycin and its salts and derivatives
Vancomycine, ses sels et dérivés
Vasopressin and its salts
Vasopressine et ses sels
Vecuronium bromide
Vecuronium (bromure de)
Vedaprofen and its salts and derivatives
Védaprofène et ses sels et dérivés
Venlafaxine and its salts
Venlafaxine et ses sels
Verapamil and its salts
Vérapamil et ses sels
Verteporfin and its salts and derivatives
Vertéporfine et ses sels et dérivés
Vidarabine
Vidarabine
Vigabatrin and its salts and derivatives
Vigabatrine, ses sels et dérivés
Vinblastine and its salts
Vinblastine et ses sels
Vincristine and its salts
Vincristine et ses sels
Vindesine and its salts
Vindésine et ses sels
Vinorelbine and its salts
Vinorelbine et ses sels
Viomycin and its salts and derivatives
Viomycine, ses sels et dérivés
Vitamin A in oral dosage form containing more than 10,000 International Units of Vitamin A per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 10,000 International Units ofVitamin A
Vitamine A présentée en unités posologiques orales contenant chacune plus de 10 000 unités internationales de vitamine A ou dont la plus forte dose quotidienne recommandée sur l’étiquette résulte en l’ingestion,par une personne, de plus de 10 000 unités internationales de vitamine A
Vitamin B12 with Intrinsic Factor Concentrate
Vitamine B12 avec concentré de facteur intrinsèque
Vitamin D in oral dosage form containing more than 1,000 International Units of Vitamin D per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 1,000 International Units ofVitamin D
Vitamine D présentée en unités posologiques orales contenant chacune plus de 1 000 unités internationales de vitamine D ou dont la plus forte dose quotidienne recommandée sur l’étiquette résulte en l’ingestion,par une personne, de plus de 1 000 unités internationales de vitamine D
Xanthinol nicotinate
Xantinol (nicotinate de)
Xylazine and its salts
Xylazine et ses sels
Yohimbine and its salts
Yohimbine et ses sels
Zafirlukast and its salts
Zafirlukast et ses sels
Zalcitabine and its salts
Zalcitabine et ses sels
Zanamivir and its salts and derivatives
Zanamivir et ses sels et dérivés
Zidovudine
Zidovudine
Zoledronic acid and its salts and derivatives
Acide zolédronique et ses sels et dérivés
Zomepirac and its salts
Zomépirac et ses sels
Zopiclone and its salts
Zopiclone et ses sels
Zuclopenthixol and its salts and derivatives
Zuclopenthixol, ses sels et dérivés
Part II
Acepromazine and its salts
Acépromazine et ses sels
Acetanilide
Acétanilide
Adrenocortical hormones and their salts and derivatives, (except hydrocortisone or hydrocortisone acetate, when sold as a single medicinal ingredient in a concentration that provides 0.5% hydrocortisone in preparations for topical use on the skin)
Hormones corticosurrénales, leurs sels et dérivés (sauf l’hydrocortisone et l’acétate d’hydrocortisone vendus comme ingrédient médicinal unique dans les préparations pour usage topique sur la peau et présents dans celles-ci en concentration de 0,5 % d’hydrocortisone)
Aminopyrine and its derivatives
Aminopyrine et ses dérivés
Amprolium and its salts
Amprolium et ses sels
Antipyrine (except preparations for topical use)
Antipyrine (sauf dans les préparations pour usage topique)
Apramycin and its salts
Apramycine et ses sels
Azithromycin and its salts and derivatives
Azithromycine, ses sels et dérivés
Centella asiatica extract and active principles thereof
Centella asiatica (extrait de) et ses principes actifs
Chlorhexidine and its salts, when used as a topical oral preparation
Chlorhexidine et ses sels, dans les préparations pour usage oral topique
Chlorothiazide and its salts and derivatives
Chlorothiazide, ses sels et dérivés
Chlorpromazine and its salts
Chlorpromazine et ses sels
Cholestyramine resin
Colestyramine (résine de)
Clarithromycin and its salts and derivatives
Clarithromycine, ses sels et dérivés
Cyclizine
Cyclizine
Dihydrostreptomycin and its salts and derivatives
Dihydrostreptomycine, ses sels et dérivés
Dirithromycin
Dirithromycine
Ergot alkaloids and their salts
Ergot (alcaloïdes d’) et leurs sels
Erythromycin and its salts and derivatives
Érythromycine, ses sels et dérivés
Folic acid
Acide folique
Framycetin and its salts and derivatives
Framycétine, ses sels et dérivés
Furaltadone and its salts
Furaltadone et ses sels
Furazolidone and its salts
Furazolidone et ses sels
Furosemide
Furosémide
Griseofulvin and its salts and derivatives
Griséofulvine, ses sels et dérivés
Iron derivatives for parenteral use only
Fer, ses dérivés pour usage parentéral seulement
Kanamycin and its salts and derivatives
Kanamycine, ses sels et dérivés
Levamisole and its salts
Lévamisole et ses sels
Lincomycin and its salts and derivatives
Lincomycine, ses sels et dérivés
Liothyronine and its salts
Liothyronine et ses sels
Mebendazole
Mébendazole
Meclizine and its salts when sold in concentrations greater than 25 mg per dosage unit
Méclizine et ses sels s’ils sont vendus en une concentration supérieure à 25 mg par unité posologique
Neomycin and its salts and derivatives
Néomycine, ses sels et dérivés
Nicarbazin
Nicarbazin
Nitrofurantoin and its salts
Nitrofurantoine et ses sels
Novobiocin and its salts and derivatives
Novobiocine, ses sels et dérivés
Nystatin (except preparations for topical use on the skin) and its salts and derivatives
Nystatine (sauf dans les préparations pour usage topique sur la peau), ses sels et dérivés
Oleandomycin and its salts and derivatives
Oléandomycine, ses sels et dérivés
Penicillin and its salts and derivatives, (except amoxicillin, ampicillin, azlocillin, benzathine penicillin, carbenicillin, cloxacillin, dicloxacillin, hetacillin, mecillinam, methicillin, mezlocillin, nafcillin, oxacillin and ticarcillin and their salts and derivatives)
Pénicilline, ses sels et dérivés, (sauf amoxicilline, ampicilline, azlocilline, benzathine pénicilline, carbénicilline, cloxacilline, dicloxacilline, hétacilline, mécillinam, méthicilline, mezlocilline, nafcilline, oxacilline et ticarcilline, leurs sels et dérivés)
Physostigmine salicylate (except preparations for oral or topical use only)
Physostigmine (salicylate de), (sauf dans les préparations pour usage oral et topique seulement)
Polymyxin B and its salts and derivatives, (except for topical use or for local action in the oral cavity or nasal passages)
Polymyxine B, ses sels et dérivés, (sauf pour usage topique ou local dans la cavité buccale ou dans les voies nasales)
Primidone
Primidone
Promazine and its salts
Promazine et ses sels
Reserpine and its salts
Réserpine et ses sels
Ronidazole and its salts and derivatives
Ronidazole, ses sels et dérivés
Sex hormones, except the following:
Hormones sexuelles, sauf :
Androisoxazole
Androisoxazole
Androstanolone
Androstanolone
Androstenediol and its derivatives
Androstènediol et ses dérivés
Bolandiol and its derivatives
Bolandiol et ses dérivés
Bolasterone
Bolastérone
Bolazine
Bolazine
Boldenone and its derivatives
Boldénone et ses dérivés
Bolenol
Bolénol
Calusterone
Calustérone
Clostebol and its derivatives
Clostébol et ses dérivés
Cyproterone and its derivatives
Cyprotérone et ses dérivés
Diethylstilbestrol and its derivatives
Diéthylstilbestrol et ses dérivés
Drostanolone and its derivatives
Drostanolone et ses dérivés
Enestebol
Énestébol
Epitiostanol
Épitiostanol
Ethylestrenol
Éthylestrénol
Fluoxymesterone
Fluoxymestérone
Formebolone
Formébolone
Furazabol
Furazabol
4-Hydroxy-19-nortestosterone and its derivatives
Hydroxy-4-nor-19 testostérone et ses dérivés
Levonorgestrel, when sold in concentrations of 0.75 mg per oral dosage unit
Lévonorgestrel, s’il est vendu en une concentration de 0,75 mg par unité posologique orale
Mebolazine
Mébolazine
Megestrol and its derivatives
Mégestrol et ses dérivés
Mesabolone
Mésabolone
Mesterolone
Mestérolone
Metandienone
Métandiénone
Metenolone and its derivatives
Méténolone et ses dérivés
Methandriol
Méthandriol
Methyltestosterone and its derivatives
Méthyltestostérone et ses dérivés
Metribolone
Métribolone
Mibolerone
Mibolérone
Nandrolone and its derivatives
Nandrolone et ses dérivés
Norboletone
Norbolétone
Norclostebol and its derivatives
Norclostébol et ses dérivés
Norethandrolone
Noréthandrolone
Oxabolone and its derivatives
Oxabolone et ses dérivés
Oxandrolone
Oxandrolone
Oxymesterone
Oxymestérone
Oxymetholone
Oxymétholone
Prasterone
Prastérone
Quinbolone
Quinbolone
Stanozolol
Stanozolol
Stenbolone and its derivatives
Stenbolone et ses dérivés
Testosterone and its derivatives
Testostérone et ses dérivés
Tibolone
Tibolone
Tiomesterone
Tiomestérone
Trenbolone and its derivatives
Trenbolone et ses dérivés
Zeranol
Zéranol
Sodium fluoride (in solid oral dosage forms containing more than one milligram of fluoride ion)
Sodium (fluorure de) (sous forme posologique solide orale contenant plus d’un milligramme d’ion fluor)
Spectinomycin and its salts and derivatives
Spectinomycine, ses sels et dérivés
Spiramycin and its salts and derivatives
Spiramycine, ses sels et dérivés
Streptomycin and its salts and derivatives
Streptomycine, ses sels et dérivés
Sulphonamides and their salts and derivatives
Sulfamides, leurs sels et dérivés
Tetracycline and its salts and derivatives (except doxycycline when sold for intramuscular administration in caged birds)
Tétracycline, ses sels et dérivés (sauf doxycycline si elle est vendue pour administration intramusculaire aux oiseaux en cage)
Thiabendazole
Thiabendazole
Thyroid
Thyroïde
Tioconazole and its salts
Tioconazole et ses sels
Trimeprazine and its salts
Triméprazine et ses sels
Tylosin and its salts and derivatives (except when sold for the treatment of chronic colitis in dogs)
Tylosine, ses sels et dérivés (sauf lorsque vendu pour le traitement de la colite chronique chez le chien)
Veratrum album and its alkaloids and their salts
Veratrum album, ses alcaloïdes et leurs sels
Veratrum viride and its alkaloids and their salts
Veratrum viride, ses alcaloïdes et leurs sels
Virginiamycin and its salts and derivatives
Virginiamycine, ses sels et dérivés
Vitamin A
Vitamine A
Vitamin D
Vitamine D
Vitamin K, except Vitamin K1 and Vitamin K2 sold
(a) for external use in humans; or
(b) in an oral dosage form for use in humans if the maximum recommended daily dose is 0.120 mg or less
Vitamine K, sauf la vitamine K1 et la vitamine K2 vendues :
(a) soit pour usage externe destiné aux humains;
(b) soit sous une forme posologique orale destinée aux humains si la dose quotidienne maximale recommandée est de 0,120 mg ou moins
SCHEDULE K
Reasonable Daily Intake for Various Foods
APPENDICES I AND II
[Repealed, SOR/81-935, s. 2]
APPENDIX III
Forms
Export Certificate
(Under the Food and Drugs Act — R.S.C. 1970, c. F-27)The undersigned exporter hereby certifies that the (description of article)
packaged and labelled as follows: and marked in distinct overprinting with the word “Export”1 is not manufactured for consumption in Canada,
2 is not sold for consumption in Canada, and
3 packages and the contents of such packages do not contravene any known requirement of the law of
to which it is or is about to be consigned.
(name of country or countries)
Dated at the day of 19 .Canada : In the matter of an Export Certificate under the Food and Drugs Act,Province of To Wit :I,
of the of in the of do solemnly declare:1 that I am the “Exporter” issuing the certificate above set out and have a knowledge of the matters and facts herein declared to by me,
or
I am the of the “Exporter” issuing the certificate above set out and have a knowledge of the matters and facts herein declared to by me (describe position of declarant as the agent of the “Exporter” in case of a Corporation issuing the certificate),2 that the information set out in the said certificate is true,
3 that all information relevant to the purpose of the said certificate is set out herein and no information relevant thereto has knowingly been withheld.
Declared before me at this
day of 19 .
A Commissioner for Taking Oaths
SCHEDULE L
(Sections B.01.402, B.01.403, B.01.450 and B.01.454 to B.01.465)
Nutrition Facts Table Formats
GRAPHICS ARE NOT DISPLAYED, SEE SOR/2003-11, S. 37; ERR., VOL. 137, NO. 5
SCHEDULE M
(Sections B.01.001, B.01.002A and D.01.001)
Reference Amounts
Bakery Products
1Bread, excluding sweet quick-type rolls50 g2Bagels, tea biscuits, scones, rolls, buns, croissants, tortillas, soft bread sticks, soft pretzels and corn bread55 g3Brownies40 g4Heavy weight cake: 10 g or more per 2.5 cm cube, such as cheese cake, pineapple upside-down cake, cake with at least 35% of the finished weight as fruit, nuts or vegetables, or any of these combined125 g5Medium weight cake: 4 g or more per 2.5 cm cube but less than 10 g per 2.5 cm cube, such as cake with or without icing or filling, cake with less than 35% of the finished weight as fruit, nuts or vegetables or any of these combined, light weight cake with icing, Boston cream pie, cupcakes, eclairs or cream puffs80 g6Light weight cake: less than 4 g per 2.5 cm cube, such as angel food, chiffon or sponge cake, without icing or filling55 g7Coffee cakes, doughnuts, danishes, sweet rolls, sweet quick-type breads and muffins55 g8Cookies, with or without coating or filling, and graham wafers30 g9Crackers, hard bread sticks and melba toast20 g10Dry breads, matzo and rusks30 g11Flaky type pastries, with or without filling or icing55 g12Toaster pastries55 g13Ice cream cones5 g14Croutons7 g15French toast, pancakes and waffles75 g16Grain-based bars, with filling or partial or full coating40 g17Grain-based bars, without filling or coating30 g18Rice cakes and corn cakes15 g19Pies, tarts, cobblers, turnovers and other pastries110 g20Pie crust1/6 of 20 cm crust or 1/8 of 23 cm crust21Pizza crust55 g22Taco shell, hard30 gBeverages
23Carbonated and non-carbonated beverages, iced tea and wine coolers355 mL24Sports drinks and water500 mL25Coffee: regular, instant and specialty, including espresso, café au lait, flavoured and sweetened175 mL26Tea and herbal tea(a) regular and instant (hot)175 mL(b) flavoured and sweetened, prepared from mixes250 mL27Cocoa and chocolate beverages (hot)175 mLCereals and Other Grain Products
28Hot breakfast cereals, such as oatmeal or cream of wheat40 g dry250 mL prepared29Ready-to-eat breakfast cereals, puffed and uncoated (less than 20 g per 250 mL)15 g30Ready-to-eat breakfast cereals, puffed and coated, flaked, extruded, without fruit or nuts (20 g to 42 g per 250 mL), very high fibre cereals (with 28 g or more fibre per 100 g)30 g31Ready-to-eat breakfast cereals, fruit and nut type, granola (43 g or more per 250 mL) and biscuit type cereals55 g32Bran and wheat germ15 g33Flours, including cornmeal30 g34Grains, such as rice or barley45 g dry140 g cooked35Pastas without sauce85 g dry215 g cooked36Pastas, dry and ready-to-eat, such as fried canned chow mein noodles25 g37Starch, such as cornstarch, potato starch, tapioca starch or wheat starch10 g38Stuffing100 gDairy Products and Substitutes
39Cheese, including cream cheese and cheese spread, except those listed as a separate item30 g40Cottage cheese125 g41Cheese used as an ingredient, such as dry cottage cheese or ricotta cheese55 g42Hard cheese, grated, such as parmesan or romano15 g43Quark, fresh cheese and fresh dairy desserts100 g44Cream and cream substitute, except those listed as a separate item15 mL45Cream and cream substitute, powder2 g46Cream and cream substitute, aerosol or whipped15 g47Eggnog125 mL48Milk, evaporated or condensed15 mL49Plant-based beverages, milk, buttermilk and milk-based drinks, such as chocolate milk250 mL50Shakes and shake substitutes, such as dairy shake mix250 mL51Sour cream30 mL52Yogurt175 gDesserts
53Ice cream, ice milk, frozen yogurt and sherbet125 mL54Dairy desserts, frozen, such as cakes, bars, sandwiches or cones125 mL55Non-dairy desserts, frozen, such as flavoured and sweetened ice or pops, or frozen fruit juices in bars or cups75 mL56Sundaes250 mL57Custard, gelatin and pudding125 mLDessert Toppings and Fillings
58Dessert toppings, such as maple butter and marshmallow cream30 g59Cake frostings and icings35 g60Pie fillings75 mLEggs and Egg Substitutes
61Egg mixtures, such as egg foo young, scrambled eggs or omelets110 g62Eggs50 g63Egg substitutes50 gFats and Oils
64Butter, margarine, shortening and lard10 g65Vegetable oil10 mL66Butter replacement, powder2 g67Dressings for salad30 mL68Mayonnaise, sandwich spread and mayonnaise-type dressing15 mL69Oil, spray type0.5 gMarine and Fresh Water Animals
70Canned anchovies, anchovy paste and caviar15 g71Marine and fresh water animals with sauce, such as fish with cream sauce or shrimp with lobster sauce140 g cooked72Marine and fresh water animals without sauce, such as plain or fried fish or shellfish, or fish or shellfish cakes, with or without breading or batter125 g raw100 g cooked73Marine and fresh water animals, canned55 g74Marine and fresh water animals, smoked or pickled, or spreads55 gFruit and Fruit Juices
75Fruit, fresh, canned or frozen, except those listed as a separate item140 g150 mL canned76Candied or pickled fruit30 g77Dried fruit, such as raisins, dates or figs40 g78Fruit for garnish or flavour, such as maraschino cherries4 g79Fruit relishes60 mL80Avocado, used as an ingredient30 g81Cranberries, lemons and limes, used as ingredients55 g82Watermelon, cantaloupe, honeydew and other melons150 g83Juices, nectars and fruit drinks represented for use as substitutes for fruit juices250 mL84Juices, used as ingredients, such as lemon juice or lime juice5 mLLegumes
85Bean curd (tofu) and tempeh85 g86Beans, peas and lentils, such as white beans, kidney beans, romano beans, soybeans or chick peas100 g dry250 mL cooked or cannedMeat, Poultry, Their Products and Substitutes
87Pork rinds and bacon54 g uncooked15 g cooked88Beef, pork and poultry breakfast strips30 g uncooked15 g cooked89Dried meat and poultry, such as jerky, dried beef or parma ham, as well as sausage products with a water activity of 0.90 or less, such as salami, dried thuringer or cervelat30 g90Luncheon meats, such as bologna, blood pudding, minced luncheon roll, liver sausage, mortadella, ham and cheese loaf or headcheese; pâté; sandwich spread; potted meat food product; taco fillings; meat pie fillings and cretons75 g uncooked55 g cooked91Sausage products, such as linked sausage, Vienna sausage, wieners, breakfast sausage, frankfurters, pork sausage, bratwurst, kielbasa, Polish sausage, summer sausage, smoked sausage, smoked country sausage, pepperoni, knackwurst, thuringer or cervelat75 g uncooked55 g cooked92Cuts of meat and poultry without sauce, and ready-to-cook cuts, with or without breading or batter, including marinated, tenderized and injected cuts125 g raw100 g cooked93Patties, cutlettes, chopettes, steakettes, meatballs, sausage meat and ground meat, with or without breading or batter100 g raw60 g cooked94Cured meat products, such as cured ham, dry cured ham, back bacon, cured pork back, dry cured cappicolo, corned beef, pastrami, country ham, cured pork shoulder picnic, cured poultry ham products, smoked meat or pickled meat85 g raw55 g cooked95Canned meat and poultry55 g96Meat and poultry with sauce, such as meat in barbecue sauce or turkey with gravy, but excluding combination dishes140 gMiscellaneous
97Baking powder, baking soda and pectin0.6 g98Baking decorations, such as coloured sugars or sprinkles for cookies4 g99Bread crumbs and batter mixes30 g100Cooking wine30 mL101Cocoa powder5 g102Non-alcoholic drink mixers, such as pina colada or daiquiri250 mL103Chewing gum3 g104Salad and potato toppers, such as salad crunchies, salad crispins or substitutes for bacon bits7 g105Salt and salt substitutes, as well as seasoned salt, such as garlic salt1 g106Spices and herbs0.5 gCombination Dishes
107Measurable with a cup, such as casserole, hash, macaroni and cheese with or without meat, pot pie, spaghetti with sauce, stir fry, meat or poultry casserole, baked or refried beans, wieners and beans, meat chili, chili with beans, creamed chipped beef, beef or poultry ravioli in sauce, beef stroganoff, poultry à la king, Brunswick stew, goulash, stew, ragout or poutine250 mL108Not measurable with a cup, such as burritos, egg rolls, enchiladas, pizza, pizza rolls, sausage rolls, pastry rolls, cabbage rolls, quiche, sandwiches, crackers and meat or poultry lunch-type packages, gyros, burger on a bun, frank on a bun, calzones, tacos, pockets stuffed with meat, lasagna, chicken cordon bleu, stuffed vegetables with meat or poultry, shish kabobs, empanadas, fajitas, souvlaki, meat pie or tourtière140 g without gravy or sauce195 g with gravy or sauce109Hors d’oeuvres50 gNuts and Seeds
110Nuts and seeds, not for use as snacks: whole, chopped, sliced, slivered or ground30 g shelled111Butters, pastes and creams, other than peanut butter30 g112Peanut butter15 g113Flours, such as coconut flour15 gPotatoes, Sweet Potatoes and Yams
114French fries, hash browns, skins and pancakes85 g frozen French fries70 g prepared115Mashed, candied, stuffed or with sauce140 g116Plain, fresh, canned or frozen110 g fresh or frozen125 g vacuum packed160 g cannedSalads
117Salads, such as egg, fish, shellfish, bean, fruit, vegetable, meat, ham or poultry salad, except those listed as a separate item100 g118Gelatin salad120 g119Pasta or potato salad140 gSauces, Dips, Gravies and Condiments
120Sauces for dipping, such as barbecue, hollandaise, tartar, mustard or sweet and sour sauce30 mL121Dips, such as legume or dairy-based30 g122Major main entree sauce, such as spaghetti sauce125 mL123Minor main entree sauce, such as pizza sauce, pesto sauce or other sauces used as toppings, such as white sauce, cheese sauce, salsa, cocktail sauce or gravy60 mL124Major condiments, such as ketchup, steak sauce, soy sauce, vinegar, teriyaki sauce or marinades15 mL125Minor condiments, such as horseradish, hot sauce, mustard or worcestershire sauce5 mLSnacks
126Chips, pretzels, popcorn, extruded snacks, grain-based snack mixes and fruit-based snacks, such as fruit chips50 g127Nuts or seeds for use as snacks50 g shelled128Meat or poultry snack food sticks20 gSoups
129All varieties250 mLSugars and Sweets
130Candies, including chocolate bars and other chocolate products, except those listed as a separate item40 g131Hard candies, except those listed as a separate item15 g132Baking candies, such as chocolate chips15 g133Breath mints2 g134Roll-type hard candies and mini size hard candies in dispenser packages5 g135Confectioner’s or icing sugar30 g136Bread spreads, except those listed as a separate item, honey and molasses20 g137Jams, jellies, marmalades, fruit butters and spreads15 mL138Marshmallows30 g139Sugars, except those listed as a separate item4 g140Sugar substituteamount equivalent in sweetness to 4 g of sugar141Syrups, including chocolate, maple and corn syrup30 mL as ingredient60 mL other usesVegetables
142Vegetables without sauce, including cream style corn and stewed tomatoes, but not including vegetables without sauce listed as a separate item85 g fresh or frozen125 mL canned143Vegetables with sauce110 g fresh or frozen125 mL canned144Vegetables primarily used for garnish or flavouring, fresh, canned or frozen, but not dried, such as parsley or garlic4 g145Chili pepper and green onion30 g146Seaweed15 g147Lettuce and sprouts65 g148Vegetable juice and vegetable drink250 mL149Olives15 g150Pickles30 g151Relish15 mL152Vegetable pastes, such as tomato paste30 mL153Vegetable sauce or purée, such as tomato sauce or tomato purée60 mLIn recent years, with the increasing scarcity of fossil resources and the worsening environmental pollution, the effective utilization of wood and plastic waste has become a critical issue. In this paper, propylene glycol (PG) was used as an alcoholysis agent to degrade waste poly(ethylene terephthalate) (PET), and unsaturated polyester (UPR) was synthesized by the polycondensation reaction. The Chinese fir was modified by chemical impregnation to obtain a new type of waste PET-based wood–plastic composites. It exhibits a compressive strength of about 107 MPa and a water absorption of less than 20%. These results highlight the outstanding modification effect on fir, demonstrating excellent mechanical properties and corrosion resistance. This study presents a green and efficient method for the preparation of wood–plastic composites and the recycling of waste PET, providing promising solutions for sustainable resource utilization and environmental protection.
Wood is a natural and renewable porous polymer material. As a green and environmentally friendly material, it has always been favored by people and is widely used in construction, industrial component construction, furniture production, indoor and outdoor decoration, and paper industries. However, due to the over-exploitation of natural forests in the past and the implementation of logging ban protection measures in recent years, the supply of high-quality wood is far from enough to meet the market demand.1 Plantation trees not only have a short growth cycle but also have natural defects such as loose material, low mechanical strength, poor dimensional stability, easy mildew, and corrosion, which greatly limit their application range.2,3
PET is a high-performance engineering polymer with excellent mechanical and barrier properties; thus, it is used in large amounts nowadays, and it is widely used in plastic packaging bottles, films, and synthetic fibers.4−6 Excellent comprehensive properties make PET the third most widely used polymer in the packaging industry, almost monopolizing the entire beverage packaging bottle market.7 PET products such as plastic packaging bottles and polyester fibers have become an important part of living. The production of PET worldwide is also increasing year by year, and the annual output has increased from 42 million tons in 2014 to 74 million tons in 2020.8−10 The design life of plastic is usually 1 to 50 years, but most plastic packaging materials lose their value after a short period of use.11 Most plastics are difficult to decompose quickly in the ecosystem and easily accumulate in the environment after use, which causes serious environmental damage, known as “plastic pollution”.12
In the chemical cyclic utilization process of PET, the polymer is depolymerized into oligomers or monomers, which are then separated, purified, and used as raw materials for the production of chemical products. Chemical recycling methods include hydrolysis, methanolysis, glycolysis, amine hydrolysis, ammonia hydrolysis, and other methods.4,13 Hydrolysis is the only method that directly depolymerizes PET into TPA (terephthalic acid) and EG (ethylene glycol), and the reaction can be carried out in water media with different acid–base conditions. Since the technology for synthesizing PET directly from TPA and EG through esterification is well-established, and the production cost of TPA from para-xylene (PX) oxidation is relatively high, the recovery of TPA from waste PET materials through hydrolysis is of great significance. Hydrolysis can be classified into alkaline hydrolysis,14 acid hydrolysis,15 and neutral hydrolysis.16 Based on the different alcoholysis agents, alcoholysis methods are generally divided into glycolysis17and methanolysis,18 which are the two most commercially mature depolymerization methods. The amine hydrolysis reaction of PET mainly produces TPA diamide and EG, and the most commonly used amine hydrolysis agents are methylamine, ethylamine, ethanolamine, and other primary amines, as well as ethylenediamine and other diamines, which are generally conducted within the temperature range of 20–100 °C.16,19 In the related research of chemical recycling of waste PET, the main objectives are to improve the conversion rate and monomer yield of PET, shorten the reaction time, and conduct the reaction under milder conditions as much as possible. In recent years, numerous efforts have focused on the application of emerging technologies such as microwave heating,20 supercritical fluids,18,21 ionic liquids,22−24 deep eutectic solvents,25,26 etc. These approaches aim to address issues such as low thermal conductivity of PET, inadequate reaction contact, improvement of heat distribution in reactors, increase of depolymerization energy, enhancement of the effective contact area between PET and solvents/catalysts, and achievement of higher cyclic utilization efficiency.
Efficient cyclic utilization of discarded PET products to achieve renewable resource utilization is a major direction for the development of the green chemical industry. Duque-Ingunza et al.27 catalyzed the ethanolysis of PET with Na2CO3, and the purified product was polycondensed with maleic anhydride to produce a linear unsaturated polyester. The resin was then cross-linked and cured using peroxide acetone and cobalt 2-ethylhexanoate, achieving the performance standards of commercial unsaturated polyester resins. However, the application of the polyester in some biomaterials has not been studied. Abdullah and Ahmad28 synthesized UPR from ethanolysis of discarded PET and blended it with 0.3% coconut fibers to prepare coconut fiber-reinforced composite materials. In this study, the proportion of coconut fibers was relatively low, leaving room for further utilization of biomaterials. Wang et al.29 reacted bifunctional epoxy oligomers with poly(ethylene glycol) to produce a waterborne epoxy resin, which was then impregnated into wood to study its related properties. For the impregnation modification of fir wood, Wang et al.29 employed phenol–formaldehyde (PF) resin for chemical impregnation, while Liu et al.30 used furfuryl alcohol (FA) resin for the modification of fir and poplar wood. However, the organic compounds used in these studies not only pose harm to human health but also do not adhere to the concept of green chemistry. To the best of our knowledge, there have been few studies on the application of UPR prepared from discarded PET in wood, achieving the combination of sustainable and green resource utilization, broadening the application range of fast-growing wood, and benefiting resource conservation and environmental protection.
We will establish a connection between wood and waste PET products, using propylene glycol as an alcoholysis agent and alcoholysis under high-temperature conditions; the PET ester bond is broken and replaced by hydroxyl end groups, and then, the addition of maleic anhydride (MA) and phthalic anhydride (PA) introduces double bonds and benzene rings into the molecular chain to obtain unsaturated polyester oligomers. The schematic diagram of the reaction is shown in . Maleic anhydride provides active functional groups for the subsequent cross-linking of UPR oligomers; phthalic anhydride is used to adjust the double-bond content in the molecular chain of UPR oligomers, reduce the structural regularity, and increase the compatibility of UPR oligomers with cross-linking monomers while controlling its cross-linking density. Then, diluent styrene (St), cross-linking agent divinylbenzene (DVB), and initiator benzoyl peroxide (BPO) were added to the oligomer to prepare an impregnating liquid, which was modified by chemical impregnation.31 The impregnation liquid was injected into the wood voids and cured. The result is a wood–plastic composite material with significantly improved mechanical properties, water absorption performance, and thermal stability. This further enhances the service life of the wood, improves its corrosion resistance and insect resistance, and provides a new solution for the recycling and utilization of waste PET plastics. It should be noted that the curing process of UPR is extremely complicated. The C=C bond on the linear unsaturated polyester molecular chain undergoes a free radical copolymerization reaction with styrene, which can form four possible cross-linking structures: (i) intermolecular cross-linking with or without the styrene monomer; (ii) intramolecular cross-linking with or without the styrene monomer; (iii) branching on polyester molecules by styrene; and (iv) a free styrene homopolymer.32 Furthermore, the degree of polymerization of polystyrene between the cross-linked chains is different, and the existence of the steric hindrance effect also leads to some unreacted unsaturated double bonds in the cured product of the unsaturated polyester, which makes the resin-cured cross-linked network highly chaotic and difficult to express clearly with chemical reaction formulas.
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