PFAS in Cosmetic Products: Regulatory Trends and Safety Assessment Challenges
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Updated: 2 hours ago
Introduction
Per- and polyfluoroalkyl substances (PFAS) are a large family of anthropogenic chemicals characterised by highly stable carbon–fluorine bonds. Structurally, PFAS typically contain at least one fully fluorinated methyl (CF₃-) or methylene (-CF₂-) carbon atom.
Chemically, PFAS can be divided into polymeric and non-polymeric substances. Polymeric PFAS include fluoropolymers, polymeric perfluoropolyethers and side-chain fluorinated polymers, while non-polymeric PFAS include polyfluoroalkyl and perfluoroalkyl substances. Among non-polymeric PFAS, perfluoroalkyl acids (PFAAs) are often further classified by chain length into long-chain, short-chain and ultrashort-chain PFAS.
More than 16,000 PFAS substances have been identified. These chemicals have been widely used in consumer and industrial applications because of their oil- and water-repellent properties, as well as their resistance to heat and chemical degradation.
However, PFAS are highly persistent in the environment and may present toxicological concerns. As a result, regulatory authorities worldwide are introducing increasingly stringent restrictions and bans on PFAS uses, including in cosmetic products.
PFAS in Cosmetic Products
Technical functions in cosmetic formulations
In cosmetic products, PFAS may perform several technical functions, including:
hair and skin conditioning agents
emulsifiers and stabilisers
surfactants
oil- and water-repellent agents
Examples of PFAS substances reported in cosmetic formulations include:
polytetrafluoroethylene (PTFE)
perfluorononyl dimethicone
trifluoroacetyl tripeptide-2
tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate
perfluorohexylethyl triethoxysilane
methyl perfluorobutyl ether
methyl perfluoroisobutyl ether
PFAS may enter cosmetic products either intentionally as formulation ingredients (this is a rare situation) or unintentionally as impurities or degradation products.
Occurrence of PFAS in cosmetics
In the United States, 51 PFAS substances have been identified as intentionally added ingredients across 1,744 cosmetic product formulations.
The most frequently affected product categories include:
eye shadows
eyeliners
face powders
foundations
leave-on face and neck products
Together, these categories represent approximately 56% of PFAS-containing cosmetics.
In Europe, an analysis conducted by the Swedish Chemicals Agency (KEMI) in 2021 reported that PFAS were most frequently detected in decorative cosmetics (3.7%). Lower occurrences were identified in:
skin care products (0.78%)
hair care products (0.65%)
toiletries (0.27%)
PFAS occurrence in perfumes and fragrances was almost negligible (0.03%).
Overall, the market share of PFAS-containing cosmetic products remains relatively limited.
Increasing Global Regulation of PFAS
Regulatory scrutiny of PFAS is increasing rapidly worldwide.
Under the EU REACH Regulation, Germany, Denmark, the Netherlands, Norway and Sweden submitted a restriction proposal in 2023 targeting approximately 10,000 PFAS substances, including their use in cosmetics.
Several countries have already introduced or proposed additional restrictions:
United States: at least eleven states have introduced bans on PFAS in cosmetics
New Zealand: ban on PFAS-containing cosmetics starting January 2028, with full removal by July 2028
Canada: restrictions on long-chain PFCAs in cosmetics
Republic of Korea: prohibition of approximately 190 PFAS substances as cosmetic ingredients
As regulatory pressure increases, many cosmetic manufacturers are already moving away from PFAS use. However, replacing PFAS often requires significant reformulation efforts, as direct drop-in alternatives are rarely available.
Toxicological and Environmental Concerns
PFAS and their degradation products are extremely persistent in the environment. Their removal from surface water, groundwater, soils and sediments is technically complex and often costly.
PFAS have been detected in multiple environmental media, including:
drinking water sources
food crops
wildlife
remote geographical regions
Human biomonitoring studies show that PFAS are widely detected in human populations, indicating widespread exposure.
Exposure to certain PFAS has been associated with several potential human health effects including increased cholesterol levels, effects on the immune system, thyroid hormone disruption, impacts on infant birth weight, and increased risk of certain cancers.
Examples of health effects associated with PFAS exposure reported in the ECHA Annex XV restriction report (2023) are summarised below.
Figure . Examples of health effects associated with PFAS exposure (ECHA Annex XV Restriction Report, 2023).
Exposure Pathways in Cosmetic Products
For cosmetic products, dermal exposure is generally the primary route of exposure.
However, other exposure routes may occur depending on the type of cosmetic product:
inhalation (e.g., powders or sprays)
ocular exposure (e.g., eye makeup)
incidental ingestion (e.g., lip products)
Because cosmetics are frequently used daily, systemic exposure assessment remains a key element of cosmetic safety evaluation.
Toxicological Reference Values and Risk Assessment
Several regulatory bodies have proposed approaches to assess PFAS exposure risks.
In 2020, the European Food Safety Authority (EFSA) concluded that immune system effects represent the most critical endpoint for PFAS risk assessment. EFSA established a group tolerable weekly intake (TWI) of 4.4 ng/kg body weight per week for combined exposure to four PFAS substances:
PFOA
PFNA
PFHxS
PFOS
In 2021, the Dutch National Institute for Public Health and the Environment (RIVM) proposed a risk assessment approach using relative potency factors (RPFs), allowing exposure to multiple PFAS to be expressed as PFOA-equivalent concentrations.
More recently, the U.S. Food and Drug Administration (FDA) published a safety assessment of the 25 PFAS most frequently used in cosmetic products.
The assessment concluded that:
perfluorohexylethyl triethoxysilane may raise safety concerns
five PFAS substances (including PTFE and perfluorodecalin) present low safety concern under intended conditions of use
for 19 of the 25 substances, available data were insufficient to conduct a full safety assessment
This highlights the importance of toxicological data availability and structured risk assessment methodologies.
PFAS and Cosmetic Safety Assessment
The evaluation of PFAS in cosmetic products requires:
access to reliable toxicological data
exposure assessment
identification of appropriate toxicological reference values
calculation of the Margin of Safety (MOS) when applicable
These elements are essential for the preparation of the Cosmetic Product Safety Report (CPSR) required under the European Cosmetic Regulation.
Because PFAS data may be incomplete or evolving, toxicologists often rely on a weight-of-evidence approach, combining experimental studies, predictive tools and regulatory assessments.
Conclusion: Preparing for a Changing Regulatory Landscape
PFAS have historically provided valuable technical properties in certain cosmetic formulations. However, increasing regulatory scrutiny, environmental persistence concerns and evolving toxicological knowledge are significantly reshaping the regulatory landscape.
Cosmetic manufacturers should therefore:
review their product portfolios
evaluate supply chain disclosures
identify potential PFAS ingredients or impurities
anticipate reformulation needs
Early strategic planning is likely to be more manageable than reactive reformulation once regulatory restrictions enter into force.
Companies must also ensure that cosmetic safety assessments remain robust, transparent and well documented, particularly in the context of evolving PFAS regulations.
Toxicological Expertise for PFAS and Cosmetic Ingredients
The safety assessment of PFAS and other complex cosmetic ingredients often requires a comprehensive evaluation of toxicological data, including the identification of relevant studies, the selection of appropriate Points of Departure, and the interpretation of regulatory and scientific literature.
In many cases, available information may be fragmented across multiple sources, or important toxicological endpoints may require further evaluation through a structured toxicological profile.
CEHTRA supports cosmetic manufacturers, ingredient suppliers and regulatory teams by preparing custom toxicological profiles and safety assessments for cosmetic ingredients and impurities. These evaluations include:
identification and analysis of relevant toxicological studies
hazard characterisation across key toxicological endpoints
selection and justification of Points of Departure
support for Margin of Safety calculations
documentation supporting Cosmetic Product Safety Reports (CPSR)
These expert assessments help ensure that cosmetic ingredients are evaluated using robust and transparent methodologies aligned with current regulatory expectations.
Supporting PFAS Safety Assessment with COSMETICK
In addition to expert toxicological evaluations, CEHTRA has developed digital tools to support cosmetic safety assessment workflows.
CEHTRA supports cosmetic industry companies in product safety evaluation and regulatory compliance at European and global levels.
This digital platform COSMETICK combines a toxicological database and a cosmetic risk assessment tool, providing access to more than toxicological and ecotoxicological profiles for more than 4,000 substances, including over 100 PFAS substances.
By structuring toxicological data and supporting risk assessment workflows, COSMETICK helps toxicologists prepare robust cosmetic safety assessments and CPSR documentation.
Get expert support in assessing PFAS in your cosmetic products and ensure full compliance with evolving regulatory requirements.
Authors: Clarisse Bavoux & Pramod Kumar
