On April 14, 2023, the U.S. Food and Drug Administration filed a petition submitted by the Environmental Defense Fund (EDF) and several other NGOs requesting that the agency repeal its regulation authorizing the use of titanium dioxide as a color additive in food. The petitioners rely on a 2021 safety assessment by the European Food Safety Authority (EFSA) to support their position that titanium dioxide no longer satisfies the safety standard for color additives. FDA invites stakeholders to submit comments, scientific data, and other relevant information to the docket by July 3, 2023.
First approved by FDA for use in foods in 1966, titanium dioxide is a naturally occurring mineral that is processed, refined, and added to a wide variety of foods to enhance color and shine. It is currently authorized as a non-certified color additive in foods generally at levels up to 1% of the weight of the food. See 21 C.F.R. § 73.575. Its safety has been the subject of debate in recent years, with concerns raised about the potential for nano-sized particles purportedly present in the additive to pass through the gastrointestinal tract and accumulate in the body.
In 2021, EFSA evaluated titanium dioxide and concluded it can no longer be considered safe as a food additive because the possibility that it is genotoxic cannot be ruled out on available evidence.1 Shortly afterward, the European Commission banned titanium dioxide in food effective August 7, 2022.2 FDA and regulatory authorities in the United Kingdom, Canada, and Australia/New Zealand reviewed the EFSA opinion but issued statements affirming titanium dioxide’s safety as a food additive.3 The FAO/WHO Joint Expert Committee on Food Additives (JECFA) is scheduled to review titanium dioxide at its meeting in Rome in the Fall.4 Despite FDA’s public assurances of safety, legislators in both California and New York have introduced legislation that would prohibit the addition of titanium dioxide, as well as several other food additives that have been in use in the U.S. food supply for decades, as of January 1, 2025.5
FDA accepted the EDF petition for filing on April 14, 2023. The agency has 90 days from the date of filing to review the petition and determine whether the available data justify repealing 21 C.F.R. § 73.575, although it has discretion to extend that time for an additional 90 days. FDA published a notice in the Federal Register on May 3, 2023 announcing it has opened a docket on the petition and inviting interested stakeholders to submit comments and additional scientific data by July 3, 2023.6
If you have questions about the pending petition or would like assistance preparing comments, please reach out to us.
Authored by Martin Hahn, Andrea Bruce, and Erin Pannek.
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