Shifting Regulatory Landscape Following Detection of PFAS in Cosmetic Products

Posted on Behalf of  Kathleen Chen, Eric Russman

Per- and polyfluoroalkyl substances (PFAS) are a group of substances commonly used in cosmetics to impart preferred durability, texture, waterproofing, and shine properties (Washington Post, 2021; Associated Press, 2021). They may also be present in these products as impurities or unintentional degradation products (Glüge et al., 2020). As a result, these chemicals have been detected in a number of cosmetic products, most notably mascaras, foundations, and lipsticks (Washington Post, 2021). PFAS have been noted as substances of concern due to their ability to enter and persist in the environment, as well as their bioaccumulation potential. Further, there is a lack of transparency with regard to their use in cosmetic products, as many are not disclosed on product labels (Washington Post, 2021). As such, increases in social scrutiny and studies of adverse health effects associated with PFAS exposure have driven pressure for increased regulation. For example, as described in our previous blog, the Toxic-Free Cosmetic Act, which bans the use of 13 PFAS from products manufactured or sold in California, was passed in 2020 and will take effect on January 1, 2025 (National Law Review, 2020).

On June 15, 2021, the “No PFAS in Cosmetics Act” [S.2047] was introduced in U.S Senate in an effort to require the U.S Food and Drug Administration (FDA) to ban the addition of PFAS to cosmetic products, such as make-up, moisturizer, and perfume” (Congressional Record Vol. 167, No. 103: S4521; Washington Post, 2021). A new peer-reviewed study by Whitehead et al. (2021) was pointed to by Senators as a primary contributor that sparked this initiative (Congressional Record Vol. 167, No. 103: S4521). In this study, researchers characterized cosmetic products into three categories using total fluorine concentrations and a baseline limit of detection of 0.127 F/cm2 (Whitehead et al., 2021). Among the products tested, they found that foundations (63%), eye products (58%), and lip products (55%) were the most likely to have high total fluorine levels (characterized as >0.384 μg F/cm2), which could indicate possible presence of PFAS (Whitehead et al., 2021). A more targeted analyses of these product categories reportedly detected PFAS in a subset of 29 samples, but only one had fluorochemical ingredients listed on the label. In a recent statement, the Personal Care Products Council (PCPC) noted that “some of the fluorine levels detected could be the result of trace amounts from materials naturally occurring in the environment or as a result of the manufacturing process” (PCPC, 2021).

Currently, the FDA has a Voluntary Cosmetic Registration Program (VCRP) that provides a channel for reporting of ingredients used in commercially distributed cosmetic products by manufacturers, packers, and producers (FDA, 2021). Data from this program has elucidated general trends in the use of PFAS in cosmetics. Within a 9-month period between 2019-2020, approximately 21 PFAS types were reported in cosmetic products (FDA, 2021). In the same timeframe, it was noted that cosmetic formulations including at least one of the reported 21 PFAS’s decreased in frequency from 506 to 235. Further, a 2018 study by the Environmental Working Group (EWG) identified 13 different PFAS in approximately 200 personal care and cosmetic products from 28 different brands (Andrews & Burns, 2018). While studies on PFAS in the context of cosmetic products is limited, existing published research has mostly found PFAS concentrations to be relatively low at the “parts per billion level to the 100s of parts per million range” (FDA, 2021).

Moving forward, monitoring and analysis of PFAS use in cosmetics is expected to continue and advance. Specific areas of focus in future work include determining toxicological profiles of newer generation PFAS, the extent of systemic PFAS levels resulting from the use of cosmetics, and possible human health risks resulting from this consumer use scenario (FDA, 2021). Cosmetics represent a unique exposure scenario, as ingredients in these formulations may enter the system via dermal (e.g., absorption through skin), oral (e.g., inadvertent ingestion of lip products), and inhalation (e.g., powder formulations) routes. Additionally, considerations for product use patterns, which may differ for leave-on versus rinse-off products, should be taken into account when performing a comprehensive risk assessment of PFAS in personal care and cosmetic products. Ultimately, exposure levels from use of cosmetic products must be considered in light of total estimated PFAS body burden for consumers, who are exposed to PFAS from multiple products and in the diet (e.g., drinking water or food).

Cardno ChemRisk scientists have over 15 years of experience understanding hazard and exposure associated with perfluoroalkyl substances, or PFASs. We have previously published blogs on PFAS- related topics, such as PFAS in PPE, PFAS in food packaging, and Proposition 65 and PFAS. Please visit Cardno ChemRisk’s Consumer Products and PFAS pages for more information regarding our capabilities. For more information, please reach out to Dr. Marisa Kreider and Dr. Andrew Monnot.