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, 2023. 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.

Regulatory Approach

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 178.3297) 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:

• physical and chemical properties of the substance,   
• the manufacturing process,  
• the likely amount of consumption of foods with the additive and the estimated dietary exposure to the color additive,   
• safety data demonstrating the dose at which adverse outcomes are anticipated for short term and chronic exposure,   
• stability, and 
• the availability of analytical methods for determining the chemical purity and the amount in food.  

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.

Safety

In 2023, 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) 2021 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.

Additional Information

• Color Additives in Foods
• Inventory of Color Additives
• Regulatory Status of Color Additives
• List of Select Chemicals in the Food Supply Under FDA Review 
• Understanding How the FDA Regulates Color Additives
• Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices
• Color Additives Information for Consumers
• How Safe are Color Additives?
• FDA Works to Enhance the Assessment of Ingredients in Foods and Food Contact Substances on the Market
• How FDA’s New Approach to Reviewing Chemicals Added to Food Will Strengthen Food Safety