Per- and polyfluoroalkyl substances (PFAS) are a diverse group of human-made chemicals used in a wide range of consumer and industrial products. Certain PFAS are intentionally added as ingredients in some cosmetic products, including lipsticks, eyeshadows, moisturizers, rouges, nail polish and enamel, blushers, and cleansers. These PFAS are used in cosmetics to condition and smooth the skin and hair, making them appear shiny, or to affect product consistency and texture. Some PFAS may also be present in cosmetics unintentionally as the result of raw material impurities, or due to the breakdown of intentionally added PFAS ingredients that form other types of PFAS.
One common concern is that many PFAS break down very slowly and some accumulate in people, animals, and the environment over time, posing potential health risks. For more information on potential risks of PFAS, please see: Our Current Understanding of the Human Health and Environmental Risks of PFAS | US EPA.
Consumers of cosmetics who want to avoid PFAS should become familiar with reading the label on cosmetic products. The label of a cosmetic product sold on a retail basis must declare the ingredients in descending order of predominance. Based on information available to FDA, some common PFAS ingredients found in cosmetics include perfluorohexylethyl triethoxysilane, polytetrafluoroethylene (PTFE), tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate, trifluoropropyl cyclotetrasiloxane, and trifluoropropyl cyclopentasiloxane.
The Modernization of Cosmetics Regulation Act of 2022
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily. MoCRA requirements include:
- That FDA assess the use of PFAS in cosmetic products and the scientific evidence regarding the safety of their use in cosmetic products, including any risks associated with their use. MoCRA further provides that FDA, as appropriate, consult with the National Center for Toxicological Research to assess safety of PFAS in cosmetics.
- That FDA publish, on its website, a report summarizing the results of the safety assessment from the use of PFAS in cosmetic products, not later than December 29, 2025.
Research on PFAS in Cosmetics
There have been few studies on the presence of PFAS in cosmetics. Those studies that have been published found the concentration of certain PFAS in cosmetics as impurities or as ingredients, at levels ranging from the parts per billion to hundreds of parts per million. Not all PFAS that may be found in cosmetics can be readily measured, because the specific “fingerprint” or analytical standard for the specific PFAS may not be available, making their detection and quantitation challenging.
There is also limited research on whether PFAS in cosmetics are absorbed through the skin at levels that could be harmful to human health. A 2018 study by Denmark’s Environmental Protection Agency, the only risk assessment that has evaluated PFAS in cosmetics, was conducted on certain PFAS unintentionally present in cosmetics. The study focused on five types of PFAS impurities that were detected in the largest number of different cosmetic products and in relatively high concentrations. The researchers determined that the levels of PFAS in the individual products tested are unlikely to pose a health risk for consumers. Because data from this and other published studies are limited, they cannot be used to draw definitive conclusions about the potential health risks of PFAS in cosmetics.
Based on the currently limited information, additional research is needed to determine:
- the toxicological profiles for PFAS in cosmetics;
- the extent to which various PFAS in cosmetics can be absorbed through the skin; and
- the potential for human health risks from exposure to PFAS in cosmetics.
Based on frequency of use data available to FDA from a subset of information from industry in the now sunsetted Voluntary Cosmetics Registration Program (FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP)), there were approximately 35 types of PFAS (listed below, based on OECD definition) used as ingredients in a total of 578 cosmetic product formulations in March 2022. Although the number of types of PFAS ingredients decreased to 31 during a period of one year (through March 2023), the total number of cosmetic product formulations containing at least one type of PFAS remained largely unchanged (n=570).
|TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE
|METHYL PERFLUOROBUTYL ETHER
|METHYL PERFLUOROISOBUTYL ETHER
|HC YELLOW NO. 13
|ETHYL PERFLUOROBUTYL ETHER
|ACETYL TRIFLUOROMETHYLPHENYL VALYLGLYCINE
|TRIFLUOROPROPYL DIMETHICONE/TRIFLUOROPROPYL DIVINYLDIMETHICONE CROSSPOLYMER
|TRIFLUOROMETHYL C1-4 ALKYL DIMETHICONE
|ETHYL PERFLUOROISOBUTYL ETHER
|C9-15 FLUOROALCOHOL PHOSPHATE
|PERFLUORONONYL DIMETHICONE/METHICONE/AMODIMETHICONE CROSSPOLYMER
|ACRYLATES/PERFLUOROHEXYLETHYL METHACRYLATE COPOLYMER
|POLYPERFLUOROETHOXYMETHOXY DIFLUOROETHYL PEG PHOSPHATE
|PEG-8 TRIFLUOROPROPYL DIMETHICONE COPOLYMER
|POLYPERFLUOROETHOXYMETHOXY DIFLUOROHYDROXYETHYL ETHER
FDA will continue to evaluate available safety data and published studies, and also engage with stakeholders and other government agencies on an ongoing basis to fill existing data gaps.