Titanium dioxide (TiO2) is a synthetically produced white pigment, manufactured from naturally occurring ores. It is regulated by the FDA as a color additive and used in a variety of FDA regulated foods, such as bakery products and candy. The FDA is currently reviewing a Color Additive Petition filed on April 14, . The petition asks the FDA to repeal section 21 CFR 73.575 to no longer provide for the use of titanium dioxide in foods.
The FDA allows for the safe use of TiO2 as a color additive in foods according to the specifications and conditions, including that the quantity of titanium does not exceed 1% by weight of the food, as stated in FDA regulations (21 CFR 73.575). In foods that contain TiO2, it will appear on the ingredients label as either &#;artificial color&#; or &#;colored with titanium dioxide&#;, though it is not required to be listed.
Like food additives, color additives added to food, including TiO2, require pre-market review and approval by the FDA. The FDA&#;s regulations require evidence that a color additive is safe at its intended level of use before it may be added to foods. When the FDA approves the use of a color additive in foods, our regulations specify the types of foods in which TiO2 can be used and the maximum amounts allowed.
All colors added to food require FDA evaluation and authorization through a color additive regulation. There is not a Generally Recognized as Safe (GRAS) provision for color additives as there is for food additives.
In addition to the color additive regulation for TiO2 in food, there is also a regulation (21 CFR 178.) authorizing its use as a colorant in polymers that come in contact with food. The term &#;colorant&#; refers to a dye or pigment used in a food contact material such as packaging. Colors used in food contact materials are regulated as food additives. Obtaining authorization for the use of a food additive requires providing the FDA with data that demonstrates safety under the proposed conditions of use.
In the case of color additives, manufacturers submit data and information to the FDA as a color additive petition requesting approval of the intended use. The FDA evaluates the petition and publicly available information. If the data available demonstrate that the substance is safe under the proposed conditions of use, the agency issues a regulation authorizing the use of the color additive. When evaluating the safety of a new color additive or a new food use for a listed color additive, the FDA considers many factors, such as:
Post-approval, FDA scientists continue to review relevant new information to determine whether there are safety questions and whether the use of such substance remains safe under the Federal Food, Drug, and Cosmetic Act.
In , the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) re-evaluated the safety of titanium dioxide. In its summary report, JECFA concluded that TiO2 added to food is safe. Based on the available data (toxicological, biochemical, and other), the total daily intake of the substance does not represent a hazard to health.
The FDA is aware of the positions of other regulatory bodies regarding use of TiO2 as a color additive. The European Food Safety Agency&#;s (EFSA) Opinion confirmed there was no general toxicity to organs, as well as no effects on reproductive and developmental toxicity but noted that it could not rule out genotoxicity based on tests on TiO2 nanomaterials. Genotoxicity tests are commonly conducted to determine if a chemical can interact with or damage DNA, potentially causing cancer. Other international regulatory bodies including the United Kingdom&#;s Food Standards Agency (FSA), Health Canada, and Food Standards Australia New Zealand (FSANZ) have not agreed with EFSA&#;s assessment. FDA notes that some of the genotoxicity tests considered in the EFSA assessment included test materials not representative of the color additive, and some tests included administration routes not relevant to human dietary exposure. FDA did not identify concerns related to potential genotoxicity based on the data available and noted that TiO2 did not cause cancer in National Toxicology Program (NTP) carcinogenicity studies.
Titanium dioxide is a color additive used in food that can potentially accumulate in our bodies. It is associated with health risks such as DNA damage and immune system toxicity. The European Union banned the use of titanium dioxide in foods due to these safety concerns, yet the additive remains legal in the US. CSPI and other public health advocacy organizations petitioned the FDA to ban the chemical in foods in March , but the agency has yet to respond.
Titanium dioxide (TiO2) is a chemical that is currently approved for use in the US as a coloring additive in foods, medical products, drugs, and cosmetics. The additive can be found on grocery store shelves in a wide range of food products, including baked goods, chewing gum, chocolate, puddings, hard-shelled candies, frosting, dressings, sauces, and coffee creamers. Titanium dioxide does not have a nutritional or preservative function, but instead is used solely for superficial purposes, adding a white color and brightness to foods and beverages. Many foods that contain titanium dioxide are specifically marketed toward children.
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According to a database from the US Department of Agriculture, titanium dioxide is currently used in nearly 13,000 brand-name food products, including Kroger&#;s Fat Free Half-and-Half, Little Debbie&#;s Fudge Rounds, Wegmans&#; Original Mac &#;n Cheese, Marzetti&#;s Cream Cheese Fruit Dip, and Campbell&#;s Healthy Request Chunky Chicken Corn Chowder Soup. Titanium dioxide does not have to be listed by name on ingredient lists&#;instead, food companies can just call it &#;artificial color&#; or other similarly vague terms&#;meaning 13,000 products is an underestimate.
A safety evaluation by the European Food Safety Authority (EFSA) found that evidence suggests that when humans ingest food-grade titanium dioxide, small particles of titanium dioxide&#;or &#;nanoparticles&#;&#;can potentially accumulate in the human body over time and cause genetic damage. In turn, damage to DNA is one way that chemicals can cause cancer and other health problems. Accumulation of titanium dioxide nanoparticles in the body may also damage the immune and nervous systems. (That said, titanium dioxide used in mineral sunscreens isn&#;t absorbed and is considered safe and effective by the FDA.)
Due to the possible negative health effects of ingesting titanium dioxide nanoparticles, CSPI&#;s Chemical Cuisine tool currently advises consumers to avoid food products containing this additive. However, some food labels do not directly list titanium dioxide as an ingredient and instead hide the ingredient behind terms like &#;color added&#; or &#;artificial color.&#; This makes it more difficult for consumers to determine whether titanium dioxide is in a particular product, increasing the need for government action to protect consumers from the additive.
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After EFSA concluded its assessment revealing health concerns in , the European Union banned the use of titanium dioxide in foods in .
Conversely, Health Canada&#;s Food Directorate chose not to ban titanium dioxide in , although it noted uncertainties in the safety of titanium dioxide. The differences in conclusions between EFSA and Health Canada primarily relate to which studies each agency considered relevant. Health Canada considered studies with food-grade-comparable titanium dioxide to be most relevant, meaning if a study were performed with titanium dioxide nanoparticles alone, they generally did not include it in their safety assessment.
This distinction is critical. One study determined that in some food products, up to 74 percent of the food-grade titanium dioxide particles could be nanoparticles, suggesting that consideration of nanoparticle accumulation and toxicity is critical to understanding titanium dioxide&#;s health risks. Consequently, EFSA considered studies on titanium dioxide nanoparticles to be relevant for assessing food-grade titanium dioxide.
Despite warnings from public health watchdogs and studies identifying dangers associated with titanium dioxide nanoparticles, the FDA still allows the use of titanium dioxide in foods in the US. The FDA approved the use of titanium dioxide in food in . In a brief statement to industry issued in June , the FDA claims it has evaluated EFSA&#;s opinion and concluded that titanium dioxide is safe, using a rationale similar to Health Canada. Given how short this statement is and the sparse details included, it is unclear how thoroughly the FDA evaluated the evidence in this case.
CSPI and four other food safety and public health advocacy groups petitioned the FDA in March to revoke approval of titanium dioxide as an additive in food products. The FDA is required to address petitions within 180 days, but the agency has not yet responded.
CSPI will continue to raise public awareness of the health concerns surrounding titanium dioxide and encourage the federal government to reverse its approval of the dangerous additive.
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