U.S. FDA Submits Petition for Repeal of Titanium Dioxide Color Additive Regulation

On 3 May 2023 the U.S. Food and Drug Administration (FDA) announced the filing of a color additive petition under the Federal Food, Drug, and Cosmetics Act to repeal the color additive regulation for titanium dioxide in § 73.575 (21 CFR 73.575), which permits the use of titanium dioxide in foods. The petition was filed on 14 April 2023 by the Environmental Defense Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, and Environmental Working Group. Comments on this petition are due by 3 July 2023.

3E Review

Titanium dioxide is a white, opaque, naturally occurring mineral existing in several crystalline forms. Because of its bright whiteness, it is used in many kinds of products such as paints, coatings, papers, inks, toothpaste, face powder, and food coloring. However, the substance is also potentially toxic. The International Agency for Research on Cancer classifies titanium dioxide as a Group 2B carcinogen, a “possible carcinogen to humans,” based on studies of rats that inhaled the substance.

As a result of concerns over the substance, the European Union and the Gulf Cooperation Council already ban titanium dioxide. Indeed, the petitioners cite the opinion by the European Food Safety Authority (EFSA) entitled “Safety Assessment of Titanium Dioxide (E171) as a Food Additive,” which was published in May 2021, in their petition. They assert that the intended use of this color additive no longer meets the safety standard under 21 CFR 70.3(i). The petition asks the FDA to repeal section 73.575 to no longer provide for the use of titanium dioxide in foods.

More information about this petition is available on the Federal Register website.

3E Analysis

The FDA invites comments, additional scientific data, and other information related to this petition. Comments should be submitted by 3 July 2023 through the Federal eRulemaking portal using docket number FDA-2023-C-1487.

Written submission should include the docket number and may be mailed to:

Dockets Management Staff (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852