Background

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

Process and Next Steps

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

References

1. EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), Scientific Opinion on the safety assessment of titanium dioxide (E171) as a food additive. EFSA Journal 2021;19(5):6585, 130 pp. https://doi.org/10.2903/j.efsa.2021.6585.

2. Commission Regulation (EC) 2022/63 of 14 Jan. 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament of the Council as regards the food additive titanium dioxide (E171) [2022] OJ L11/1. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0063.

3. Note that while the FDA statement is not available in the agency’s website, reliable sources have reported on the agency’s position (see TDMA, US FDA confirms the safety of titanium dioxide as a food additive, TDMA (Jan. 24, 2023), https://www.tdma.info/news/us-fda-confirms-the-safety-of-titanium-dioxide-as-a-food-additive/#:~:text=The%20FDA%20continues%20to%20allow,regulations%20at%2021%20CFR%2073.575 and Watson, Elaine, SPECIAL REPORT: FDA doubles down on titanium dioxide safety as CSPI raises concerns; Skittles lawsuits dismissed, Food Navigator (Dec. 12, 2022), https://www.foodnavigator-usa.com/Article/2022/12/12/SPECIAL-REPORT-FDA-doubles-down-on-titanium-dioxide-safety-as-CSPI-raises-concerns-Skittles-lawsuits-dismissed#). See also, Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment, Interim position paper on titanium dioxide, UK Food Standards Agency (Jan. 2022), https://cot.food.gov.uk/sites/default/files/2022-01/TiO2%20COT%20Interim%20position%20paper.pdf; Food Directorate, State of the Science of Titanium Dioxide as a Food Additive, Health Canada (Jun. 2022), https://publications.gc.ca/collections/collection_2022/sc-hc/H164-341-2022-eng.pdf; and Food Standards Australia New Zealand, Titanium Dioxide as a Food Additive, Food Standards Australia New Zealand (2022), https://www.foodstandards.gov.au/consumer/foodtech/Documents/FSANZ_TiO2_Assessment_report.pdf.

4. JEFCA, List of Substances Scheduled for Evaluation and Request for Data, WHO (Nov. 2, 2022), https://www.fao.org/3/cc2758en/cc2758en.pdf.

5. See, A.B. 418, 2023-2024 Reg. Sess. (Cal.), https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202320240AB418 and A.B. A6424, 2023-2024 Reg. Sess. (N.Y.), https://www.nysenate.gov/legislation/bills/2023/a6424.

6. FDA-2023-C-1487 available at https://www.regulations.gov/docket/FDA-2023-C-1487.