What are PFAS and Why Should We Care?
Per- and polyfluoroalkyl substances (PFAS), also known as fluorinated chemicals, are a class of thousands of anthropogenic compounds containing an aliphatic fluorinated carbon chain. Produced since the 1940s, PFAS have been utilized in a wide array of consumer products and industrial applications.
Industrial uses of PFAS encompass over 200 diverse applications, including fast-food containers, anti-staining fabrics, fire-suppressing foams, personal care products (PCPs), cosmetics, medical devices, membranes in fuel cells, and membranes in chloralkali processes. Their primary function in these products is as surfactants, friction reducers, and repellents of water, dirt, and oil.
These substances are often referred to as “forever chemicals” due to the chemical stability conferred by the C-F bond, making them persistent environmental contaminants. Additionally, PFAS are highly mobile and can be transported long distances from their source of release. Environmental release occurs during the production, use, and disposal of materials containing PFAS. They predominantly migrate to the oceans and accumulate in marine sediments over the long term. Bioaccumulation in both aquatic and terrestrial species, including humans, has been widely observed.
The PFAS family includes over 4,700 substances, divided into two main classes: perfluoroalkyl substances and polyfluoroalkyl substances. The first class comprises perfluoroalkyl acids (PFAA) such as perfluoroalkyl carboxylates (PFCA) and perfluoroalkyl sulfonates (PFSA), along with perfluoroalkane sulfonamide substances. The second class includes fluorotelomer monomers, such as fluorotelomer alcohols (FTOH), fluorotelomer olefins, fluorotelomer iodides, and polyfluoroalkyl ether acids. Components of both classes can be polymers or non-polymers.
PFAS have been linked to various adverse health outcomes and environmental issues. Studies have shown associations between PFAS exposure and health problems, including cancers (such as kidney and testicular cancer), endocrine disruption, liver damage, immunotoxicity resulting in weakened immune responses, and reproductive and developmental issues. Environmentally, PFAS do not degrade easily, leading to long-term contamination. They have been detected in water supplies, including drinking water, soil and sediment, and wildlife, where they can bioaccumulate and biomagnify up the food chain.
PFAS in Cosmetics
Although PFAS are still used in cosmetics, their usage is rare. PFAS are added to cosmetics for their water-repellent and long-lasting qualities, commonly found in products such as foundation, mascara, and lipstick. They enhance texture, wear, and finish by providing a silky smooth application, improving durability against oil and water, and contributing to a glossy, attractive finish in lipsticks and lip glosses.
Some PFAS may also be present in cosmetics inadvertently due to impurities in raw materials or the breakdown of intentionally added PFAS ingredients that form other types of PFAS.
Based on information available to the FDA, some common PFAS ingredients found in cosmetics include perfluoroethyl triethoxysilane, polytetrafluoroethylene (PTFE), tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate, trifluoropropyl cyclohexylsiloxane, and trifluoropropyl cyclopentasiloxane.
Based on usage frequency data available to the FDA from a subset of industry information under the now-discontinued Voluntary Cosmetic Registration Program (VCRP), there were approximately 35 types of PFAS used as ingredients in a total of 578 cosmetic product formulations as of March 2022. Although the number of PFAS types decreased to 31 within a year (by March 2023), the total number of cosmetic product formulations containing at least one type of PFAS remained essentially unchanged (n=570).
Results from a Danish survey show that various fluoroalkyl substances and other fluorinated compounds are present in cosmetic products. This project focuses only on fluoroalkyl substances. According to the databases examined, polytetrafluoroethylene (PTFE) was found in most types of products, followed by C9-15 fluoroalcohol phosphate. In general, fluoroalkyl substances are used in a wide range of products, with particular emphasis on foundations, BB/CC[1] cream, creams/lotions, and powders. The highest measured concentrations were found in foundations; the highest measured value was 2,160 ng/g for perfluorooctanoic acid (PFOA). Examples of the substances used are listed in the following Table (data from Tænk Kemi, Pers. comm, 2017):
Table A – Overview of the presence of fluoroalkyl substances and other fluorinated compounds in cosmetic products as well as number of product scans within the specified product types, cf. the app ‘Kemiluppen’ from Tænk Kemi (data from Tænk Kemi, Pers. comm, 2017).
Studies on PFSA in Cosmetics
Few studies have been conducted on the presence of PFAS in cosmetics in particular as impurities. The published studies have found the concentration of some PFAS in cosmetics either as impurities or as ingredients, at levels ranging from parts per billion to hundreds of parts per million. Not all PFAS that may be found in cosmetics can be easily measured because the specific “fingerprint” or analytical standard for certain PFAS might not be available, making their detection and quantification challenging.
Overall, the data highlight that cosmetics and personal care products can contain a wide range of PFAS at extremely high levels, leading to human and environmental exposure.
Published studies from 2022 suggest that the levels of PFAS in cosmetics might be higher than previously thought. An article in Environmental Science & Technology aimed to further delineate the contributions of various PFAS sources in these products. Thirty-eight cosmetics and personal care items were selected and analyzed for polyfluoroalkyl phosphates (PAPs), perfluoroalkyl carboxylic acids (PFCAs), fluorotelomer sulfonic acids (FTSAs), and perfluoroalkyl sulfonic acids (PFSAs) using targeted liquid chromatography-tandem mass spectrometry (LC-MS/MS). A subset of products was also screened for over 200 compounds using high-resolution mass spectrometry (HRMS).
The results indicated a predominant and ubiquitous presence of PAPs (detection frequency 99.7%, mean and median ΣPAP of 1,080,000 and 299 ng/g). The median total concentrations of PFCAs and PFSAs were significantly lower, at 3 and 38 times less, respectively. Significant correlations (Spearman correlation coefficients = 0.60–0.81, p < 0.05) were observed between 6:2 PAP and its biotransformation products. Low levels of other PFAS classes, including those previously measured in wastewater and human blood (e.g., hydrido-PFCA) and five compounds associated with aqueous film-forming foams, were detected.
Overall, the data highlight that cosmetics and personal care products can contain a wide range of PFAS at extremely high levels, leading to human and environmental exposure.
Dermal Absorption of PFAS in Cosmetic Products: What’s there to Know
A study published in Environmental International examined the dermal absorption of per- and polyfluoroalkyl substances (PFAS) from sunscreen applied to a male subject. The study investigated whether perfluoroalkyl acids (PFAA) in cosmetics could penetrate human skin.
A defined amount of 13C4-perfluorooctanoic acid (13C4-PFOA) was mixed into sunscreen and applied to the subject’s entire skin. Plasma concentrations of 13C4-PFOA were measured over 115 days. Results showed a continuous increase in plasma levels, peaking at 132 ng/L after 22 days, which is 9.4% of the subject’s background PFOA level. The estimated half-life was 1.8 years, with about 1.6% of the applied dose being absorbed.
The study concluded that transdermal absorption of PFOA from cosmetics is significant, challenging the notion that this exposure route is negligible. Epidemiological studies support this finding, showing associations between PFAA exposure and cosmetic use.
Based on the currently limited information, further research is needed to determine:
- The toxicological profiles of PFAS in cosmetics;
- The extent to which various PFAS in cosmetics can be absorbed through the skin; and
- The potential health risks from exposure to PFAS present in cosmetics.
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.
What Are the Future Restrictions for Per- and Polyfluoroalkyl Substances (PFAS)?
In recent years, numerous countries have taken steps to regulate the use of PFAS in consumer products. For instance, in Europe, the European Chemicals Agency (ECHA) has proposed significant restrictions on PFAS.
In the United States, some states have enacted laws banning specific PFAS in cosmetic items. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) exemplifies efforts in the U.S. to ensure the safety of cosmetic products. MoCRA mandates that the FDA conduct assessments on the use of PFAS in cosmetics, evaluate scientific evidence regarding their safety and associated risks, and collaborate with the National Center for Toxicological Research as necessary. By December 29, 2025, the FDA is required to publish a comprehensive report summarizing its findings on PFAS safety in cosmetics.
Several European countries including Germany, Denmark, the Netherlands, Norway, and Sweden jointly submitted a proposal to ECHA in January 2023 aimed at restricting per- and polyfluoroalkyl substances (PFAS) under REACH regulations. This proposal, now detailed on the ECHA website, seeks to restrict and possibly ban nearly 10,000 PFAS variants. Its comprehensive approach includes prohibiting PFAS production within the EU, restricting their use in industrial processes and consumer products, and controlling the import and sale of PFAS-containing products to minimize overall exposure.
Overall, these regulatory efforts reflect a concerted global response to mitigate the risks associated with PFAS, emphasizing stringent measures to enhance consumer safety and environmental protection.
The proposal is justified by extensive scientific evidence highlighting the risks posed by PFASs:
- Persistence and Bioaccumulation: PFASs are known as “forever chemicals” due to their resistance to environmental degradation and their tendency to accumulate in living organisms.
- Widespread Contamination: The pervasive use of PFASs has led to widespread environmental and human exposure, necessitating urgent regulatory intervention.
- Public Health Concerns: The potential for long-term health effects from PFAS exposure underscores the need for stringent controls.
The restriction proposal sets specific limits for different types of PFAS. The proposed thresholds for PFAS concentration provide clear benchmarks for compliance:
- 25 ppb for any PFAS: This threshold applies to individual PFAS substances measured using targeted analysis, excluding polymeric PFASs.
- 250 ppb for the sum of PFASs: This sum threshold, also measured through targeted analysis, optionally considers precursor degradation, excluding polymeric PFASs.
- 50 ppm for PFASs: This threshold includes polymeric PFASs, requiring manufacturers, importers, or downstream users to demonstrate compliance with total fluorine content upon request.
These thresholds reflect a pragmatic approach to regulating PFAS across different applications, ensuring that environmental and health risks are minimized while allowing sufficient time for industries to adjust.
Various risk management options (RMOs) were evaluated to determine the most effective measures to mitigate these risks. After thorough analysis, a REACH restriction was identified as the preferred risk management measure. This restriction aims to minimize releases of PFAS into the environment, considering their inherent chemical stability which poses challenges throughout their entire lifecycle, including disposal as waste.
Two main restriction options were considered:
- Restriction Option 1 (RO1) proposes a full ban on all PFAS. This stringent measure would come into effect after an 18-month transition period.
- Restriction Option 2 (RO2) proposes a ban on all PFAS except for specific uses that may qualify for time-limited derogations. These derogations would allow additional time (either five or 12 years after the transition period) for industries to develop and transition to viable alternatives.
- Five-year derogation: Granted when alternatives to PFAS are identified but are still in the development phase or not available in sufficient quantities.
- Twelve-year derogation: Granted when there is strong evidence that no technically and economically feasible alternatives are currently available or foreseeable in the near future.
Each derogation requires a robust evidence base to justify its necessity. If the evidence is insufficient at the time of submission, the derogation may not be supported initially but could be reconsidered if strengthened evidence becomes available during the consultation process.
The proposed restrictions on PFAS aim to strike a balance between environmental protection and practical industry considerations. By encouraging the development and adoption of safer alternatives while allowing for necessary transitions, these measures seek to reduce environmental risks associated with PFAS effectively.
Furthermore, in June 2024, the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) provided a robust scientific and socio-economic basis to tackle chemical risk management challenges in the EU. They focused on restricting PFAS in key sectors like consumer mixtures, cosmetics, ski wax, metal plating, and metal product manufacturing. The committees emphasized the environmental persistence of PFAS and found the exclusion of certain PFAS based on potential degradation unjustified. These provisional opinions will be finalized and communicated once the entire restriction proposal is fully evaluated.
Below are the planned and achieved key dates for the PFAS restriction proposal:
- March 22, 2023: Start of the six-month consultation period.
- April 5, 2023: Online information session to explain the restriction process.
- September 22, 2023: End of the six-month consultation period.
- 2024: Opinions from the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC).
- 2025: Decision by the Commission and entry into force.
- 2026/2027: Restriction comes into effect.
Socio-Economic Impact
The Annex XV Restriction Report by ECHA describes the socio-economic impacts of Restriction Options (ROs) on PFASs. Industries may face significant costs associated with transitioning to alternative substances or technologies. The section emphasizes the importance of companies’ response in understanding the costs of different ROs and provides details on expected costs and underlying analysis. The lack of evidence of alternatives affects the proposal of exemptions, with potential exemptions requiring additional evidence to be justified. The strength of evidence is a fundamental criterion considered by Dossier Submitters when proposing exemptions to restrictions. Evidence can come from literature, stakeholder consultations, regulatory precedents, coherence principles, or expert judgment. Depending on the robustness of the evidence, exemptions are proposed. Potential exemptions supported by weak evidence require further data to be justified.
The Annex XV Restriction Report by ECHA provides a detailed overview of the costs and impacts of Restriction Options for PFASs, highlighting how business decisions, supporting evidence, and the availability of alternatives influence the economic and social outcomes of proposed restrictions.
Table 8 of the Annex XV Restriction Report by ECHA provides summary information on alternatives and expected costs resulting from a total ban on PFASs (RO1) across all sectors of use, while the impacts of RO2 are described in Table 9. The relevant sections of Annex E for each sector are indicated in the tables, and the cosmetic sector is referenced below.
Table B. Table 8. RO1 – Summary table of alternatives and cost impacts for PFAS manufacture and major PFAS use sectors resulting from a full ban of PFASs.
Table C. Table 9. RO2 – Summary table of derogations (‘proposed’ or ‘for reconsideration’) for PFAS manufacture and major PFAS use sectors, with substantiation for the derogation period (5 or 12 years) and with cost impacts for the 5 and 12 year derogation periods.
The Annex XV Restriction Report by ECHA represents a critical step in addressing the significant risks posed by PFASs. By proposing comprehensive restrictions on the manufacture, use, and market placement of these substances, the report aims to protect human health and the environment from the persistent and harmful effects of PFASs. As regulatory pressures increase and public awareness grows, the transition to safer, sustainable alternatives will be essential in mitigating the long-term impacts of these pervasive chemicals.
Regarding the cosmetic sector, it is assumed that technically and economically feasible alternatives to PFASs are available. Therefore, it is concluded that there is a high potential for substitution, supported by sufficiently strong evidence, and the costs of reformulation should not result in significant loss of performance or for consumers. This supports the decision not to grant exemptions from the proposed restrictions.
Risk assessment of fluorinated substances in cosmetic products
A Danish study (October 2018) analyzed cosmetic products for the presence of fluorinated substances, selecting five perfluoroalkyl acids (PFCAs) for risk assessment: PFOA, PFBA, PFPeA, PFHxA, and PFHpA. These compounds were chosen because they were found in various types of products and at high concentrations. The risk assessment considered skin absorption and serum concentrations to determine the Margin of Safety (MoS).
The results showed that in scenarios with 2% and 70% skin absorption, the MoS was well over 100 for individual cosmetic products, indicating no risk to consumers. Even in the most extreme scenario, with 70% absorption, the MoS was 34, which is still above the safety threshold of 25. However, the combined use of multiple products simultaneously could reduce the MoS below 25, suggesting a risk only in extremely conservative scenarios.
The assumptions used in the assessment were very conservative, especially the 70% absorption based on studies showing actual absorption of 25%. PFCA concentrations in products exceed future European Union limits of 25 ng/g for PFOA and for the sum of PFCAs from C9 to C14. Fluorinated substances are extremely persistent, accumulating in the environment and potentially increasing human exposure.
In conclusion, PFCA concentrations in cosmetic products do not represent a significant risk to consumers when products are used individually. However, the combined use of multiple products containing PFAS could pose a risk in highly conservative scenarios.
The report concludes with recommendations for consumers and policymakers to mitigate potential risks and suggests further research and regulatory actions.
[1] BB can stand for both Beauty Balm and Blemish Balm. CC stands for Color Corrector.
Article Issued by Maria Labianca
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