PFAS in Cosmetics: Preparing for Future Restrictions
Introduction
Per- and polyfluoroalkyl substances (PFAS)—a class of thousands of synthetic chemicals characterized by carbon-fluorine bonds that confer exceptional stability, water and oil repellency, and thermal resistance—emerged as a priority regulatory concern across the EU during 2022 [1]. PFAS have been widely used in cosmetic products as film formers, emulsifiers, and surfactants, particularly in long-lasting makeup, waterproof mascara, foundation, and hair care products [2]. However, mounting evidence of environmental persistence, bioaccumulation, and potential adverse health effects, including immunotoxicity, hepatotoxicity, and endocrine disruption, prompted regulatory action under the REACH framework (Regulation (EC) No 1907/2006) [3]. In February 2023, five European regulatory authorities (Germany, Denmark, the Netherlands, Norway, and Sweden) submitted a restriction proposal to the European Chemicals Agency (ECHA) seeking to ban the manufacture, placing on the market, and use of PFAS across all sectors, including cosmetics, with limited exemptions [4].
The PFAS restriction proposal represented one of the most ambitious chemical restrictions ever attempted under REACH, potentially affecting thousands of substances and numerous product categories [5]. For the cosmetic industry, the proposal created significant uncertainty regarding the scope of restrictions, transition timelines, and availability of suitable alternatives [6]. Article 3 of Regulation (EC) No 1223/2009 requires that cosmetic products be safe for human health, and Article 4 designates the Responsible Person as accountable for ensuring compliance with all applicable requirements, including ingredient restrictions [7]. The intersection of REACH restrictions and cosmetic-specific regulations necessitated proactive planning, ingredient screening, and reformulation strategies to prepare for future PFAS prohibitions [8].
Regulatory Framework and Legal Analysis
The REACH restriction process, governed by Articles 68-73 of Regulation (EC) No 1907/2006, empowers Member States and ECHA to propose restrictions on the manufacture, placing on the market, or use of substances that pose unacceptable risks to human health or the environment [9]. The restriction proposal must include a dossier demonstrating that the risk is not adequately controlled and that a restriction is the most appropriate EU-wide measure [10]. ECHA’s Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) evaluate the proposal, and the Commission adopts a final decision, which is directly applicable across all Member States without requiring national transposition [11].
The PFAS restriction proposal, submitted in February 2023, defined PFAS broadly as substances containing at least one perfluorinated methyl group (CF₃-) or perfluorinated methylene group (-CF₂-), encompassing an estimated 10,000+ substances [12]. The proposal sought to restrict PFAS in all products, including cosmetics, with transition periods ranging from 18 months to 12 years depending on the product category and availability of alternatives [13]. For cosmetics, the proposal suggested a transition period of 5 years for most applications, recognizing the need for reformulation and validation of alternative ingredients [14].
Under Regulation (EC) No 1223/2009, REACH restrictions are implemented through amendments to Annex II (list of substances prohibited in cosmetic products) or Annex III (list of substances subject to restrictions) [15]. Article 14 requires that the Commission amend the Annexes to take account of technical and scientific progress, and Article 32 establishes a procedure for adapting the Annexes through implementing acts [16]. Once a REACH restriction is adopted, the Commission typically amends Annex II or III to reflect the restriction, ensuring consistency between the two regulatory frameworks [17].
The PFAS restriction proposal raised several complex legal and technical questions. First, the broad definition of PFAS captured substances with widely varying properties, uses, and risk profiles, including some substances that may not exhibit the persistence, bioaccumulation, and toxicity characteristics that motivated the restriction [18]. Second, the proposal’s scope extended to substances used as intermediates or processing aids, potentially affecting manufacturing processes even if the final cosmetic product did not contain PFAS [19]. Third, the proposal included exemptions for certain essential uses where no suitable alternatives exist, but the criteria for “essential use” remained subject to debate [20].
From a cosmetic regulatory perspective, the PFAS restriction intersects with several provisions of Regulation (EC) No 1223/2009. Article 10 requires a safety assessment addressing all relevant toxicological endpoints, and the SCCS Notes of Guidance (10th Revision, SCCS/1602/18) emphasize that safety assessors must consider persistence, bioaccumulation, and environmental fate when evaluating ingredient safety [21]. Article 11 requires that the Product Information File contain the cosmetic product safety report (CPSR), and Part A of the CPSR must include information on the physicochemical properties and toxicological profile of each ingredient [22]. If PFAS are present in a formulation, the CPSR must address their safety, including consideration of dermal absorption, systemic exposure, and potential for bioaccumulation [23].
Article 13 CPNP notification requires disclosure of the product’s formulation, including all ingredients, enabling poison centers and enforcement authorities to identify products containing PFAS [24]. Article 19 labelling requires that all ingredients be listed in descending order of weight, using INCI nomenclature, and consumers have the right under Article 21 to request information from the Responsible Person regarding the presence and safety of specific ingredients [25]. These provisions create transparency regarding PFAS use and facilitate enforcement of restrictions once adopted [26].
Toxicological and Safety Science Considerations
The toxicological profile of PFAS is highly variable, reflecting the structural diversity of this chemical class [27]. Long-chain PFAS, such as perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), have been extensively studied and demonstrate persistence, bioaccumulation, and toxicity, including hepatotoxicity, immunotoxicity, developmental toxicity, and potential carcinogenicity [28]. These substances have been restricted under the Stockholm Convention on Persistent Organic Pollutants and are listed in Annex XVII of REACH, with restrictions on manufacture and use [29]. Short-chain PFAS, developed as alternatives to long-chain PFAS, are less bioaccumulative but remain highly persistent and have raised concerns regarding environmental contamination and potential health effects [30].
In cosmetics, PFAS are used primarily for their functional properties, including water and oil repellency, film formation, and emulsification [31]. Common PFAS ingredients include perfluoropolyethers (used in foundations and primers), polyfluorinated acrylates (used in mascaras and eyeliners), and fluorinated surfactants (used in cleansers and hair care products) [32]. These substances typically have high molecular weights (>1,000 Da) and low dermal absorption, resulting in minimal systemic exposure under normal use conditions [33].
The SCCS has not issued comprehensive opinions on PFAS as a class, but has evaluated specific fluorinated ingredients. For example, SCCS/1545/14 on perfluoropolyethers concluded that these substances are safe for use in cosmetics at concentrations up to 10%, based on low dermal absorption, absence of systemic toxicity in repeated-dose studies, and lack of genotoxicity or reproductive toxicity [34]. However, the SCCS noted that environmental persistence and potential for bioaccumulation should be considered in the overall safety assessment [35].
Dermal absorption studies using Franz diffusion cells and ex vivo human skin demonstrate that high-molecular-weight PFAS (>1,000 Da) exhibit minimal penetration through intact skin, with dermal absorption typically <1% [36]. Systemic exposure dosage (SED) calculations for these substances yield very low values, and margins of safety (MoS) typically exceed 1,000, indicating a large safety margin [37]. However, the persistence of PFAS in the environment and potential for indirect human exposure through drinking water, food, and environmental contamination complicate the risk assessment [38].
The hazard-versus-risk paradigm is particularly relevant for PFAS, as the primary concern is environmental persistence and long-term ecological impact rather than acute human toxicity from cosmetic use [39]. The REACH restriction proposal adopted a precautionary approach, prioritizing elimination of persistent substances regardless of immediate toxicity, reflecting the EU’s commitment to the “safe and sustainable by design” principle articulated in the Chemicals Strategy for Sustainability [40]. This approach contrasts with traditional cosmetic safety assessment, which focuses on human health risk under normal use conditions, and highlights the evolving regulatory landscape where environmental considerations increasingly influence ingredient restrictions [41].
Practical Compliance Guidance
For Responsible Persons, preparing for PFAS restrictions requires a systematic, multi-phase approach. First, comprehensive ingredient screening must identify all PFAS in current product portfolios [42]. This is challenging because PFAS are not always identifiable from INCI nomenclature, and many cosmetic ingredients are complex mixtures where PFAS content may not be immediately apparent [43]. Suppliers should be required to provide declarations confirming the presence or absence of PFAS, using the broad definition proposed in the ECHA restriction dossier [44]. Analytical verification using techniques such as liquid chromatography-mass spectrometry (LC-MS) or total organic fluorine (TOF) analysis may be necessary to confirm supplier declarations [45].
Second, reformulation strategies must balance regulatory compliance with product performance and consumer acceptance [46]. PFAS are used in cosmetics specifically for their unique functional properties, and identifying suitable alternatives that provide equivalent performance without PFAS is technically challenging [47]. Alternative film formers include silicones, acrylates copolymers, and polyurethanes, but these may not provide the same water and oil repellency as PFAS [48]. Alternative surfactants include hydrocarbon-based and silicone-based surfactants, but formulation adjustments may be necessary to achieve desired texture and stability [49].
Third, safety assessment under Article 10 must address alternative ingredients, ensuring that replacements do not introduce new safety concerns [50]. The CPSR must document the safety rationale for replacement ingredients, including dermal absorption data, repeated-dose toxicity studies, and skin sensitization testing consistent with SCCS guidance [51]. If alternative ingredients are novel or lack comprehensive safety data, additional testing may be required, potentially including in vitro assays, read-across from structurally similar substances, or, as a last resort, targeted in vivo studies [52].
Fourth, CPNP notification updates under Article 13 must be submitted for reformulated products, including revised ingredient lists and updated safety assessments [53]. Article 19 labelling must accurately reflect the reformulated ingredient list, and artwork changes may be necessary if PFAS ingredients were prominently featured in marketing communications [54]. If products are marketed with “PFAS-free” or similar claims, these must be substantiated under Article 20 and Commission Regulation (EU) No 655/2013, with evidence demonstrating absence of PFAS using validated analytical methods [55].
Fifth, supply chain management becomes critical, as PFAS may be present in raw materials, packaging materials, or manufacturing equipment [56]. Article 5 obligations on distributors require verification that products comply with applicable requirements, and distributors should implement supplier verification procedures to ensure PFAS-free status [57]. For products manufactured by contract manufacturers, Responsible Persons should include PFAS-free requirements in manufacturing agreements and conduct periodic audits to verify compliance [58].
Sixth, Responsible Persons should monitor the ECHA restriction process, including RAC and SEAC opinions, stakeholder consultations, and Commission decision timelines [59]. The restriction proposal includes transition periods, and early reformulation may provide competitive advantage and reduce supply chain disruption [60]. Industry associations, such as Cosmetics Europe, provide updates on the restriction process and coordinate industry responses, and Responsible Persons should engage with these organizations to stay informed and contribute to policy discussions [61].
Conclusion
The PFAS restriction proposal submitted to ECHA in February 2023 represented a paradigm shift in chemical regulation, prioritizing environmental persistence and long-term sustainability over traditional risk-based assessment focused on immediate human health effects. For the cosmetic industry, the proposal created significant uncertainty and necessitated proactive planning, ingredient screening, and reformulation strategies. While many PFAS used in cosmetics demonstrate low dermal absorption and minimal systemic toxicity, their environmental persistence and potential for bioaccumulation motivated precautionary restriction under REACH. Responsible Persons must navigate the intersection of REACH restrictions and cosmetic-specific requirements under Regulation (EC) No 1223/2009, implementing comprehensive compliance programs that address ingredient screening, reformulation, safety assessment, notification updates, and supply chain verification. As the EU continues to advance the Chemicals Strategy for Sustainability and the “safe and sustainable by design” principle, the cosmetic industry should anticipate additional restrictions on persistent substances and prioritize development of inherently safer, more sustainable ingredients and formulations.
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