FDA Announces Petition to Revoke Listing for TiO2 as Food Colorin

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FDA Publishes Stance on Titanium Dioxide in Food

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Tuesday, March 12, 2024

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On March 4, 2024, FDA published a webpage discussing the use of titanium dioxide (TiO2) as a color additive in foods. The webpage, which references a color additive petition requesting to revoke the listing for the use of TiO2 in foods, represents a stronger FDA stance regarding the safety of the additive.
TiO2, listed at 21 CFR 73.575, is a synthetically prepared white pigment that may be safely used as a color additive in nonstandardized foods at no more than 1 percent by weight of the food. TiO2 may also be used as a colorant in food contact materials, such as packaging materials, under 21 CFR 178.3297.
FDA highlighted a recent report from the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives (JECFA) that concluded that TiO2 is safe for use in food and that based on the available data, the total daily intake of the substance does not represent a hazard to health. Although the European Food Safety Authority (EFSA) took the position in a 2021 opinion that it could not rule out genotoxicity from TiO2, other international regulatory bodies have found the substance to be safe. According to the United Kingdom’s Food Standards Agency, Health Canada, and Food Standards Australia and New Zealand, there is no evidence to support that TiO2 presents any safety concerns when used in food. In addition, FDA stated 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.” Overall, FDA also did not identify genotoxicity concerns related to TiO2 and noted that the substance did not cause cancer in National Toxicology Program carcinogenicity studies.
The Codex Alimentarius Commission Committee on Food Additives will consider the JECFA and EFSA findings at its April meeting in Chengdu, China.
TiO2 was originally included in the list of substances California considered prohibiting in 2023; however, it was removed before the state passed the California Food Safety Act, banning four other substances from use in food.