On May 3, 2023, the U.S. Food and Drug Administration (FDA) filed a color additive petition submitted by Environmental Defense Fund, proposing to repeal the color additive regulation providing for the use of titanium dioxide in foods. FDA invites stakeholders to submit comments via electronic filing system before July 3, 2023.
Titanium dioxide, chemically abbreviated as TiO2, is a naturally occurring mineral used in foods to enhance color and shine after processed and refined. In food, it is commonly used in products like ice creams, chocolates, all types of candy, creamers, desserts, marshmallows, chewing gum, pastries, spreads, dressings, cakes, etc. TiO2 is also often used as a food coloring agent called "titanium white" or E number E171. It is generally present in up to 1% by weight of the food under Code of Federal Regulations Title 21 73.575 (21 CFR 73.575).
However, its safety is under debate in recent years. There are concerns that long-term ingestion of titanium dioxide, as an ingestible nanomaterial, may be toxic, particularly to cells and functions of the gastrointestinal tract, and lead to diseases such as inflammatory bowel disease and colorectal cancer. In this proposal, the Environmental Defense Fund quoted the European Food Safety Authority’s (EFSA) report entitled "Safety Assessment of Titanium Dioxide (E171) as a Food Additive" as a reference. As per the report, the risk of genotoxicity, which could lead to carcinogenic effects, cannot be ruled out, and a safe daily intake level of the food additive cannot be established". In addition, France has banned the use of TiO2 whitener in food since 2020 due to the uncertainty about the safe amount for human consumption.
Nonetheless, TiO2 is widely used in the food and feed industries in China. In GB 2760-2014 National Food Safety Standard Standard for Uses of Food Additives, TiO2 can be used as a coloring agent in a variety of foods. GB 1886.341-2021 National Food Safety Standard Food Additive Titanium Dioxide also provides detailed descriptions of the sensory indicators, physical and chemical indicators, as well as the detection methods of TiO2 as a food additive. In Japan, TiO2 can also be added to food as a coloring agent. Details like content specifications, use standards, are stipulated in the Specification and Standards for Food, Food additives, Etc.
Currently, the proposal to ban TiO2 in food is still in the two-month consultation period. If the proposal is approved, TiO2 will no longer be allowed as a food additive. Foods containing this additive will need to be either replaced by alternatives, or gradually be withdrawn from the market, which will lead to significant changes in the US food industry. ChemLinked advises companies exporting food products containing TiO2 to the US to closely monitor updates on this proposal.