The U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. While the report reviews available scientific evidence on potential safety concerns, the FDA’s evaluation did not reach definitive safety determinations and underscores significant uncertainty due to gaps in existing data on PFAS exposure through cosmetics.
Based on mandatory cosmetic product listing data submitted to the FDA, 51 PFAS are used in 1,744 cosmetic formulations. To assess safety, the FDA evaluated the 25 most frequently used PFAS, which represent approximately 96% of PFAS intentionally added to cosmetic products. The agency found that “toxicological data for a majority of these PFAS are incomplete or unavailable,” limiting its ability to fully assess risk. The FDA’s ability to effectively collect toxicology data was limited by the fact that most of the data is not publicly available. While five PFAS appeared to present low safety concerns under their intended conditions of use, the safety of most PFAS could not be definitively established, and one PFAS(Perfluorohexylethyl triethoxysilane) was identified as having a potential safety concern with significant remaining uncertainty.
In the United States, approximately 70% of states have introduced regulatory measures concerning the use of PFAS in cosmetics. For example, California, as the first major jurisdiction to comprehensively ban all PFAS in cosmetics, passed relevant legislation in September 2022, with enforcement to begin on January 1, 2025. Minnesota and Colorado will prohibit the sale, offering for sale, or distribution of cosmetics containing intentionally added PFAS starting January 1, 2025. Maine has stipulated a ban on the sale of PFAS-containing cosmetics effective from 2026. Connecticut will prohibit the manufacture, sale, and distribution of cosmetics with intentionally added PFAS starting January 1, 2028. Washington State will ban the sale of cosmetics containing intentionally added PFAS, among eight restricted substances or substance classes, starting January 1, 2026.
Due to their high chemical stability, hydrophobic and oleophobic properties, low surface tension, and excellent film-forming capabilities, PFAS are widely used across various industrial and consumer product sectors-including cosmetics. Currently, PFAS are commonly found in a variety of cosmetic products such as lotions, facial cleansers, nail polishes, shaving creams, foundations, lipsticks, eyeliners, eyeshadows, and mascaras. However, given their potential health risks, companies are encouraged to actively implement PFAS risk management strategies in response to tightening regulatory trends.
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Further Information:
https://www.fda.gov/news-events/press-announcements/fda-finds-insufficient-data-determine-safety-pfas-cosmetic-products
