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May 4, 2023

FDA Seeks Comment on Request to Revoke the Color Additive Listing for Use of Titanium Dioxide in Food

Lynn L. Bergeson Carla N. Hutton

The U.S. Food and Drug Administration (FDA) announced on May 3, 2023, that it has filed a color additive petition (CAP 3C0325), submitted by the Environmental Defense Fund (EDF), the Center for Environmental Health (CEH), the Center for Food Safety (CFS), the Center for Science in the Public Interest (CSPI), and the Environmental Working Group (EWG). 88 Fed. Reg. 27818. The petition proposes that FDA repeal the color additive regulation for titanium dioxide in 21 C.F.R. Section 73.575, which permits the use of titanium dioxide in foods. FDA states that the petitioners assert that the intended use of titanium dioxide no longer meets the safety standard under 21 C.F.R. Section 70.3(i), “and cite, as evidence, an opinion by the European Food Safety Authority (EFSA) entitled ‘Safety assessment of titanium dioxide (E171) as a food additive’ that was published in May 2021 . . ., and other publications.” FDA invites comments, additional scientific data, and other information related to the issues raised by the petition. FDA states that if it determines that the available data justify repealing Section 73.575 to no longer provide for the safe use of titanium dioxide in foods, it will publish its decision in the Federal Register in accordance with 21 C.F.R. Section 71.20. Comments are due July 3, 2023.

As reported in our January 14, 2022, blog item, the European Commission (EC) announced on January 14, 2022, that it adopted a ban on the use of titanium dioxide (E171) as a food additive. The ban applied after a six-month transition period, and beginning summer 2022, titanium dioxide (E171) may no longer be added to food products. According to the EC, titanium dioxide “is used to impart white colour to many foods, from baked goods and sandwich spreads to soups, sauces, salad dressing and food supplements.” The EC states that European Union (EU) member states unanimously endorsed the EC’s proposal, put forward in October 2021. The EC based its proposal on EFSA’s scientific opinion that concluded that E171 could no longer be considered safe when used as a food additive. More information is available in the EC’s questions and answers (Q&A).