In the news – Titanium Dioxide Regulation in California

02 Sep.,2024

 

In the news – Titanium Dioxide Regulation in California

In the news &#; Titanium Dioxide Regulation in California

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Titanium dioxide continues to make headlines. In this post, we take another look at titanium dioxide safety and the proposed California ban. Let&#;s dive into titanium dioxide.

What is titanium dioxide?

Titanium dioxide is a white, powdery substance that is widely used as a pigment, brightening agent, and protectant in various food, cosmetics, pharmaceuticals, and other industrial uses.

It is a naturally occurring oxide of the metal titanium. Titanium dioxide forms when titanium is exposed to oxygen, creating many differing titanium oxides found in minerals, dusts, sands, and soils. 

Titanium dioxide has excellent light-scattering properties, making it valuable in products that require a bright white color or opacity. It is commonly used in cosmetics, sunscreen, paints, coatings, plastics, food products, and many other applications where its brightening and reflective properties are desired.

Manufacturers source this mined mineral from rutile, brookite, and anatase. It is then processed and refined to meet stringent safety guidelines based on the end-use of the mineral.

Titanium dioxide added to foods and other ingestible products is commonly known as E 171, indicating its high food-grade purity.

What does titanium dioxide do?

Titanium dioxide amplifies and brightens white opacity because of its exceptional light-scattering properties. In food and drugs, these properties help to define colors clearly and can prevent products from UV degradation.

In cosmetics, titanium dioxide&#;s properties enhance coloration and can help protect skin from damaging UVA and UVB rays.

How are we typically exposed to titanium dioxide?

There are many ways we&#;re exposed to titanium dioxide in our everyday life. Below are the most common ways we come into contact with titanium dioxide.

Digestive System Exposure

We&#;re frequently exposed to E 171 through the foods we ingest. We find E 171 in many food products, like popsicles, ice cream, gum, and more. Another way we ingest E 171 is through pharmaceutical drugs. Many pills and capsules contain E 171 as an inactive ingredient.

Less frequently, we ingest E 171 through liquids such as salad dressing, dairy products, and some artificially colored drinks. However, since E 171 is insoluble, manufacturers must use other stabilizers to keep E 171 suspended in liquids as an emulsion; otherwise, it will settle to the bottom.

Topical Exposure

We apply titanium dioxide to our skin through sunscreens, makeup, lip balms, nail polish, and other cosmetic products.

We even use titanium dioxide when brushing our teeth, as it&#;s found in many toothpastes.

Respiratory Exposure

In industrial settings, people can be exposed to titanium dioxide through inhalation. Inhalation exposure to titanium dioxide is exceedingly rare for most people.

Why does the exposure route matter, and does titanium dioxide harm our health?

How we&#;re exposed to an ingredient matters significantly regarding our long-term health.

Research shows that inhaling titanium dioxide particles in significant quantities over time can cause adverse health outcomes. Unless you work in an industrial setting, inhaling substantial amounts of titanium dioxide is highly unlikely.

Research supports that applying titanium dioxide to the skin through sunscreens, makeup, and other topical products does not pose any health risks.

Overwhelmingly, research relevant to human eating patterns shows us that E 171 is safe when ingested typically through foods and drugs (1,2,3).

Other research suggests that E 171 could cause harm; however, those research processes did not consider how people are typically exposed to E 171. Research that adds E 171 to drinking water, utilizes direct injections, or gives research animals E 171 in drinking water through a feeding apparatus is not replicating typical human exposure. It's important to note that in these studies, when titanium dioxide is consumed in liquid form, it can settle if proper emulsification is not achieved. This can result in uneven and unpredictable titanium dioxide exposure to the research animals.

Let&#;s take a deeper look at titanium dioxide in foods.

E171 is not a singular ingredient; it&#;s always combined with other ingredients (e.g., proteins and fats) in the food product. Digesting food is a slow process for the body compared to drinking a beverage, which passes much more quickly through the body (1,2).

When E 171 is part of a food product, it passes through the digestive system without causing harm because E 171 combines with the other ingredients and absorption through the gastrointestinal tract is miniscule.

In some studies, researchers gave E 171 to animals in drinking water without the stabilizers that keep E 171 suspended in the liquid. Without stabilizers, E 171 can settle and prevent the ingredient from combining with surrounding ingredients. When E 171 isn&#;t combined with other ingredients, it can drastically alter the way it&#;s processed in the body, which could produce adverse health impacts.

However, humans are not exposed to E 171 in drinking water in any significant quantity over a long duration, so this potential effect is irrelevant to the human experience. It&#;s important to understand that a potential hazard is not the same as an actual risk.

Why does California want to ban titanium dioxide?

There are concerns that titanium dioxide may adversely impact our health. However, the studies linking titanium dioxide to adverse health outcomes didn&#;t reflect actual human exposure in real-life settings (1,2).

Additionally, some regulatory organizations have raised concerns about titanium dioxide particles used in food products. They worry because some particles can be smaller than 100 nanometers, which is considered "nano" size. However, it's important to note that most of these particles in food are larger, typically in the micron diameter range (1,000 nanometers).

Particles smaller than 100 nanometers tend to clump together, or agglomerate, when they come into contact with water or digestive fluids. As a result, their ability to pass through biological barriers becomes extremely limited. Similarly, particles larger than 100 nanometers struggle to move across these barriers because they are too big.

California has a unique relationship with ingredients and has legislation in place, such as Proposition 65, which requires warning labels on products made using any chemical known to cause adverse health impacts, even if adverse health events only occur in extremely high irrelevant doses or other outlying situations, that do not occur to the public. Proposition 65 labeling laws are in addition to the current federal regulations. 

The new bill, AB-418 Food product safety, goes above Proposition 65 warning labels to ban titanium dioxide and four additional ingredients (brominated vegetable oil, potassium bromate, propylparaben, and red dye 3) from foods sold in California. 

As of publication, the bill is currently under review and awaiting a final vote. 

What happens if titanium dioxide is banned in food products in California? 

If a ban on titanium dioxide is passed and upheld, companies will need to reformulate products or no longer sell products containing titanium dioxide in California.

Will a titanium dioxide ban in California impact drugs or cosmetics?

Per our understanding, the ban presently focuses on food products, not pharmaceutical medication or cosmetics. Therefore, we&#;d anticipate titanium dioxide would still be found in drugs and cosmetics, for the time being.  

The good news.

Current research continues to demonstrate that titanium dioxide exposure at levels within federal regulations is safe for humans. Federal regulatory agencies work to ensure the safety of the ingredients found in the products we use and consume. While California may choose a divergent path from the other states regarding ingredient regulation, our federal laws continue to provide recommendations and regulations for the products in our everyday lives.

If you have any questions about foods and ingredients, please reach out to us on Twitter, send us an , or submit your idea to us at go.msu.edu/cris-idea

Is Titanium Dioxide in Food Harmful?

Skittles has been making headlines in recent weeks and not because a new flavor has been added to the popular "taste the rainbow" candy.

Mars Wrigley, the company that makes Skittles, is being sued by a California man who claims the candy contains a "known toxin" that poses such a serious health risk that Skittles are "unfit for human consumption."

The ingredient in question? Titanium dioxide.

A legal additive in the United States, titanium dioxide is used in everything from food to consumer goods and the U.S. Food and Drug Administration says regulated use of the product as a color additive in food is safe within certain restrictions.

Still, in Skittles publicly declared it would get rid of the chemical compound in its products, according to a press release at the time from the Center for Food Safety, which called the substance "harmful and potentially poisonous." But the ingredient remains, according to the lawsuit, which alleges the candy company is misleading consumers by not having eliminated titanium dioxide.

The California plaintiff is apparently not the only one concerned about titanium dioxide. The European Union recently banned its use citing concerns about serious health consequences.

In response to the allegations, Justin Comes, vice president of research and development at Mars Wrigley North America, told Health that "safety is of paramount importance to Mars Wrigley. While we do not comment on pending litigation, all Mars Wrigley ingredients are safe and manufactured in compliance with strict quality and safety requirements established by food safety regulators, including the FDA."

So, what does it all mean for you, the consumer? Should you stop eating Skittles or begin checking foods for the presence of titanium dioxide? Here's a closer look.

What Is Titanium Dioxide?

An inorganic chemical, titanium dioxide is used as a dye to help products achieve a certain appearance, including whitening a product. Some experts and publications have described it as being akin to a "paint primer" that's used before the color is added to food in order to give products a uniform shine. Its presence is common in many items beyond Skittles including coffee creamers, cake mixes, and chewing gum. It's also used for pigment and in cosmetics manufacturing.

"Titanium dioxide particles help light scatter and reflect," Kelly Johnson-Arbor, MD, a medical toxicology physician at the National Capital Poison Center, told Health. "Because of that, we often use it as a whitening agent."

While Skittles don't include white in their line-up, Dr. Johnson-Arbor theorizes that titanium dioxide is used to help contain all the other beautiful colors.

Other food manufacturers use titanium dioxide to absorb water and keep moisture from clumping or degrading, Paul Westerhoff, PhD, an environmental engineer at Arizona State University who researches the biological and cellular effects of titanium dioxide, told Health.

The chemical is also found in common household and industrial products such as paints, coatings, adhesives, paper, plastics and rubber, printing inks, coated fabrics and textiles, as well as ceramics.

It's also used in sunscreens as a UV filtering ingredient, helping to protect a person's skin by blocking absorption the ultraviolet light that can cause sunburn and cancer.

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"It's all over the place in our environment," said Dr. Johnson-Arbor.

Does It Cause Cancer?

One of the most common worries about titanium dioxide is that it could be a cancer-causing agent. The link between cancer and titanium dioxide traces back to a study where rats were exposed to high levels of titanium dioxide for two years, causing lung cancer. However, not all experts are convinced by this study.

"if you compare the levels&#;which went as high as 50,000 milligrams/killigrams per day&#; to what humans are actually exposed to, we're talking orders of magnitude. It was a huge amount," Norbert Kaminski, PhD, a professor of pharmacology & toxicology and director of the Center for Research on Ingredient Safety at Michigan State University told Health.

Yet another study, this one published in by the International Agency for Research on Cancer said there was insufficient evidence to conclude that titanium dioxide causes cancer. However, the study also categorized the ingredient as a potential human carcinogen.

Since then, there has been a few animal studies suggesting titanium dioxide is connected to cancer. A study in Scientific Reports, for instance, found that rats with titanium dioxide in their diet had impaired immune systems, which could contribute to autoimmune diseases and colorectal cancer.

Still many experts say the body of research does not support the current health concerns being expressed about titanium dioxide.

A review on past studies of titanium dioxide and rat lung cancer, for instance, said the original study was under extreme conditions and its effects were not replicated in other animal species. Additionally, the review concluded that the few studies which did directly focus on titanium dioxide's impact on humans did not end up showing any increased cancer risk.

"The whole scientific experimental design in some of these studies is&#; very flawed," Kaminski said.

On the other hand, Westerhoff said, there are hundreds of studies showing no adverse effects from the substance.

"Relative to a lot of other things that people should be concerned about, titanium dioxide in my mind, is really low on the list. I would be more worried about some substitutes that people are using for titanium dioxide that don't have decades of research associated with it," said Westerhoff.

Additional Health Concerns Linked to Titanium Dioxide

There is some evidence that ingested titanium dioxide does not completely exit the body. A review of animal studies and a few human studies suggests titanium dioxide can get absorbed into the bloodstream and expose other organs to damage.

"The concern from animal studies is that high amounts of titanium dioxide have increased inflammation and colon tumor formation," said Dr. Johnson-Arbor. A review, meanwhile, suggested that using titanium dioxide as a food additive weakens the gut lining and worsens the progression of inflammatory bowel disease.

Separately, concerns have been raised about titanium dioxide impacting one's genetic code. This can be traced to a study which found that titanium dioxide nanoparticles caused DNA damage and genetic instability in mice. A study published in Food and Chemical Toxicology also raised concerns about the DNA-damaging effects of titanium dioxide as a food additive. The study noted that "results evidenced a DNA-damaging effect," and added that there may also be impacts to "chromosomal integrity, an indicator of cancer risk."

Other scientists, however, have called into question the experimental designs of such studies, citing inconsistent results specifically in studies used to test DNA damage.

In June , Health Canada weighed in on the debate, releasing a report on the safety of titanium dioxide. Their expert panel reviewed toxicity studies, including ones involving genetic damage. The expert panel found that previous studies used different forms and properties of titanium dioxide and deliberately broke the material into smaller particles than what you would normally see in food.

For his part, Kaminski argues most of the studies have been in animals, and any effects found were minuscule. He and his team also contested some of the findings in a study that found no evidence of increased inflammation or changes in the GI tract.

"We've measured many different immunological markers, both in the mucosa of the intestine and the lymphoid organs part of the intestine and we didn't see any inflammation there or changes in white blood cell number," Kaminski said. They also looked at the spleen where titanium dioxide was taken up into the bloodstream. "You would expect [titanium dioxide] would be filtered out in the spleen and maybe induce inflammation there, but we did not see that," Kaminski added.

Why Did Europe Ban Titanium Dioxide?

As of August 7, the use of titanium dioxide in food is banned in the European Union. Europe is taking a precautionary principle approach based on findings from the European Food Safety Authority (EFSA).

According to the EFSA's Expert Panel on Food Additives and Flavorings opinion regarding titanium dioxide, it could not rule out a concern for genotoxicity from ingestion of the material based on a perceived gap in data on this risk, which serves as the basis for current ban, said a March report on the decision.

A safety review conducted by the EFSA in assessed thousands of studies published on titanium dioxide.

"Although the evidence for general toxic effects was not conclusive, on the basis of the new data and strengthened methods we could not rule out a concern for genotoxicity and consequently we could not establish a safe level for daily intake of the food additive," commented Matthew Wright, member of the EFSA's Food Additives and Flavourings Panel in a press statement.

It's also worth noting that even prior to the EU decision, France had already outlawed titanium dioxide in food back in January .

The US and Canada, however, approve the use of titanium dioxide as a food additive. Canada's recent review of titanium dioxide reconfirmed its safety and pointed out that many of the toxicity studies the EU reviewed were not relevant to the safety of titanium dioxide as a food ingredient, and that the ban is based on an abundance of caution and uncertainty.

What's the Verdict?

Ultimately, most experts advise moderation, as titanium dioxide is typically found in processed foods that come with their own health risks.

"People eating lots of candy should be more worried about the sugar and how it can cause high blood pressure and obesity," says Westerhoff.

Other experts say there is simply no conclusive evidence at this point that titanium dioxide is damaging to humans after ingesting. Kaminski in particular said the research studies cite health hazards that were found by using high doses of the product, which "you would not normally see in food."

"I don't see the scientific evidence in the literature that would cause people any concern," said Kaminski.

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