Regulation of per- and polyfluoroalkyl substances ("PFAS") under Regulation (EC) No. 1907/2006 ("REACH") in the EU and EEA by means of a broad restriction of production, use and placing on the market is moving forward towards adoption in 2027 line with the European Commission's Chemicals Strategy for Sustainability Towards a Toxic-Free Environment1 and the European Chemicals Industry Action Plan2, which proposes a set of initiatives to support the transition away from PFAS.
On 26 March 2026, the European Chemicals Agency ("ECHA") launched its final consultation on the proposed restriction of PFAS, which is one of the most significant regulatory developments in EU chemicals law in recent years.
The consultation invites industry, all stakeholders and members of the public to provide comments on the draft opinion of ECHA's scientific Committee for Socio-Economic Analysis ("SEAC") to help inform SEAC's final opinion, which is expected by the end of 2026. The consultation is open until 25 May 2026.
Together with the final opinion adopted by ECHA's scientific Committee for Risk Assessment ("RAC") on the hazards and risks to human health and the environment associated with PFAS, SEAC's final opinion on the socio-economic benefits and costs of the proposed PFAS restriction will conclude ECHA's scientific evaluation of the proposed restriction. Both committee opinions will serve as a basis for the European Commission's formal legislative proposal for the restriction of PFAS by draft amendment to Annex XVII of REACH, which the Commission plans to present shortly after receiving both committees' final opinions.3
With PFAS regulation continuing as a topic of regulatory concern worldwide,4 businesses across all sectors should consider commenting on SEAC's draft conclusion, monitor developments closely, assess their PFAS exposure and liability risks, and prepare for compliance.
This alert sets out the key findings of RAC's final conclusion and SEAC's draft conclusion, assessing the tensions in their respective approach and highlighting key takeaways for businesses.
Background
In January 2023, authorities from five EU Member States ("Dossier Submitters") submitted to ECHA a proposal to restrict the manufacture, use and placing on the market of PFAS as a group of very persistent chemical substances in the EU and EEA under REACH. Following a six-month consultation on the original restriction proposal, the Dossier Submitters published a revised proposal (the "Background Document") in June 2025. In essence, the Dossier Submitters propose a group-based restriction within the meaning of the OECD definition5 above any of three proposed concentrations (depending on the analytical method used), unless exempted by one of the use-specific, mostly time-limited derogations.
As a result of their analysis of the comments received in the six-month consultation of their original proposal and incorporated later into the Background Document, the Dossier Submitters expanded the assessment from originally 14 specific sectors6 and manufacture of PFAS7 by eight additional sectors.8 These additional eight sectors are, however, not subject to RAC's and SEAC's in-depth assessment.
Scientific Committee Conclusions
RAC's conclusion and SEAC's draft conclusion operate on different planes: RAC's opinion assesses risk management (i.e., whether a restriction is the most appropriate measure to reduce risk), while SEAC's opinion assesses socio-economic proportionality of the restriction proposed by the Dossier Submitter. In essence, SEAC's assessment shifts the debate's focus from risk assessment to the economic feasibility of substitution and proportionality.
Final RAC Opinion
Below, we summarise the key modifications RAC proposes to the Dossier Submitter's restriction proposal in its final opinion dated 2 March 2026 on the basis of its risk management assessment:
RAC's recommended regulatory approach
Noting the limited data available, RAC considers current risk management measures and operational conditions to not sufficiently address the risk of PFAS, with PFAS releases presenting a risk that increases with continued use, resulting in build-up of environmental stocks of PFAS already released to the environment globally over9 time.
In contrast to the Dossier Submitter, who proposed numerous derogations for specific uses from the PFAS restriction (so-called RO210), RAC deems a full EU-wide restriction on the manufacturing, placing on the market and use of PFAS, and of articles and mixtures containing PFAS in the EU and EEA following a transition period of 18 months from entry into force with only very limited derogations to be the most appropriate way to limit the risks to human health and the environment and to avoid regrettable substitution.11
Regulatory concern, grouping approach and general 18-month transition period
RAC agrees with the Dossier Submitter that the very persistent property of PFAS, along with other, although diverging, properties of concern, such as (eco)toxicity, mobility, bioaccumulation, long-range transport and global warming potential, present grounds for a significant concern for human health and for the environment. Once PFAS are present in the environment, their removal from surface water, groundwater, soil, sediment and biota is considered to be technically extremely difficult and very costly, if at all possible, resulting in constantly increasing concentrations of PFAS in the environment as well as unavoidable and irreversible exposure that may give rise to risks for human health.
RAC accepts that the proposed ban shall not take immediate effect but rather be subject to a general transition period of 18 months from the restriction's entry into force (which typically is on the twentieth day following the amending regulation's publication in the Official Journal of the European Union), consistent with the approach successfully employed in other legislation.
Treatment of PFAS as non-threshold substances
RAC concurs with the Dossier Submitters that PFAS should be treated as non-threshold substances for the purpose of risk assessment in a similar manner to PBT/vPvB substances,12 meaning substances for which no reliably safe exposure level can be established, with even minimal releases deemed to pose long-term risks to health and the environment, so that emissions are taken to be a proxy for risk and should therefore be minimised.13
Chemical scope of the restriction
RAC supports the use of the broad OECD definition for PFAS for the purpose of grouping the substances.
While the Dossier Submitters propose to exclude substances that only contain structural elements CF3-X or X CF2-X'14 from the scope of the restriction on the basis that these are fully degradable, RAC rejects this limitation of the chemical scope on the grounds that insufficient evidence exists to justify the proposed exclusion from the restriction.
With regard to fluoropolymers, RAC recognizes that there is limited evidence of mobility, bioaccumulative potential and (eco-)toxicological effects, but nonetheless includes them in the scope of the broad restriction in light of notable life-cycle concerns. Specifically, fluoropolymer production and waste are considered to result in emissions of non-polymeric PFAS, and the use and waste stages of fluoropolymers may further result in the formation of micro- and nano-sized polymer particles.
Similarly, RAC includes volatile PFAS, especially fluorinated gases, in the chemical scope of the PFAS restriction (despite recognising that fluorinated gases are generally of low toxicity to humans and to the environment and that some specific fluorinated gases, especially certain hydrofluoroolefins (HFOs), have lower global warming potential) in light of them being very persistent, very mobile and major contributors to PFAS emissions with global warming and long-range transport potential.
Restriction mechanics and concentration limits
Regarding the three cumulative concentration limits proposed by the Dossier Submitters for PFAS to come within the scope of the restriction, RAC
- highlights the strong need for a harmonised enforcement strategy including standardised analytical methods and methods for sample preparation;
- generally supports the 50 ppm (mg/kg) concentration limit set for total PFAS in a sample for total PFAS (including polymeric PFAS, e.g. fluoropolymers, for which analytical reference standards are not yet available, so that a total fluorine content analysis shall be used to demonstrate the presence of organic fluorine15)
- notes that the 25 ppb concentration limit for any individual PFAS measured with targeted PFAS analysis (excluding polymeric PFAS from quantification) may not be currently achievable for certain PFAS with the currently available analytical methods; and
- recommends that for the concentration limit of 250 ppb set for the sum of targeted PFAS measured by targeted analysis, sample degradation ought to be set as a requirement in the restriction text (except in cases where it is not feasible).
Derogations
The Dossier Submitters' draft restriction text sets out derogations in three main blocks: Overarching derogations in paragraph 4; a large list of sector- and use-specific derogations for all PFAS within the scope of the proposed restriction in paragraph 5 (many of them time-limited); and sector- and use-specific derogations for fluoropolymers and perfluoropolyethers in paragraph 6 (also time-limited).
Overarching derogations
Draft paragraph 4 of the Dossier Submitters' proposed PFAS restriction sets out a series of overarching, cross-sector derogations that would apply regardless of the specific use of PFAS involved. These include derogations for active substances in biocidal products, plant protection products and medicinal products, second-hand articles, spare parts, upstream supply chain, Product and Process Oriented Research and Development ("PPORD"), recycling, and PFAS manufacturing under emission limits. RAC in principle accepts the derogations proposed by the Dossier Submitters in draft paragraph 4 of their restriction text, noting, for example:
- Current legislation on biocidal products (Regulation (EU) 528/2012), plant protection products (Regulation (EC) 1107/2009), and medicinal products (Regulation (EC) 726/2004, Regulation (EU) 2019/6 and Directive 2001/83/EC) does not fully address the concern associated with the emissions of persistent PFAS to the environment and, therefore, should incorporate sector specific regulation to minimise emissions from the use of PFAS as active substances in these products in case of a derogation.
- The need for careful control of emissions especially related to the manufacturing of spare parts and disposal of spare parts in the end-of-life phase by means of (1) the requirement for site-specific management plans for suppliers of spare parts making use of this derogation, and (2) information obligations of companies making use of this derogation to inform users about the PFAS content and safe use and disposal of the products. Regarding the certificate required to prove the recovered origin of paper and board, textiles and plastic in articles manufactured from recycled materials, RAC notes potential challenges in enforcement and acknowledges that a maximum concentration limit for PFAS in recycled material could be an effective risk mitigation measure. However, since such a concentration limit was not identified in the Dossier Submitters' proposal, RAC could not establish such a limit.
- Regarding the Dossier Submitters' proposal to provide for a time unlimited derogation under draft paragraph 4m. for the production of PFAS coupled with emission control measures reaching a specific minimum effectiveness (in the form of emission factors), RAC could not provide a definitive view on the technical feasibility of the emission factors because this needs to be assessed specifically for each individual site. In addition, RAC has identified several challenges related to the practicality of the calculation of the emission factors. Should the decision-maker consider a derogation for PFAS manufacturing is appropriate, RAC, however, acknowledges that the establishment of emission limits (emission permits and environmental management system established by the Industrial Emissions Directive) is the most adequate measure to reduce the risk. This, if fully applied by local authorities and if supported by up-to-date best available techniques ("BAT") conclusions for PFAS manufacturing, could offer significant emission reduction potential; effective enforcement would also be instrumental to achieve emission minimisation. However, at present and with the information available, RAC found itself unable to identify such emission limits. In view of RAC's inability to define emission limits with the information available and the potentially extended time needed to develop BAT conclusions for PFAS manufacturing, RAC suggests introducing requirements to implement site-specific PFAS management plans, including monitoring of emissions to the environment, for each PFAS manufacturing site. This is in line with the requirements proposed for other industrial sites, should their use of PFAS be allowed to continue. In addition, according to RAC, PFAS manufacturers should provide instructions for safe use and disposal to their downstream users.
Other Sector-/use-specific derogations
In contrast, RAC does not support adoption of the numerous sector- or use-specific derogations proposed by the Dossier Submitters in their draft paragraphs 5 and 6 for various industrial uses and applications, except for the derogations for (i) personal protective equipment ("PPE") intended to protect users against risks as specified in Regulation (EU) 2016/425, Annex I, (ii) PPE specifically designed for the armed forces, the maintenance of law and order and other emergency response workers, and (iii) impregnating agents for re-impregnation of PPE to prevent negative effects on the health and safety of workers, in each case for 13.5 years as of the entry into force of the restriction (cf. draft paras. 5 a. through c. of the Dossier Submitters' proposal)16.
This is a key difference in approach, which increases the pressure on businesses relying on the multiple use-specific derogations proposed by the Dossier Submitters that lack scientific support from RAC.
RAC acknowledges that the Commission may, nonetheless, decide to implement sector-/use-specific derogations as proposed by the Dossier Submitters and/or SEAC. In such cases, RAC recommends adopting additional risk management measures to ensure minimisation of associated emissions (see below for details). Should the decision-maker consider a derogation for PFAS manufacturing, RAC deems establishment of emission limits for PFAS as systematically adopted for other substances in emission permits and environmental management systems established under the Industrial Emissions Directive as the most adequate measure to reduce the risk. However, at present and with the information available, RAC is not able to identify such emission limits for PFAS.
Derogation mechanics / risk management measures / conditions for derogated continued PFAS uses
RAC recommends that all continued uses of PFAS or PFAS-containing articles or mixtures be accompanied by additional risk management measures to ensure minimisation of associated emissions. According to RAC, such additional risk management measures should include:
- Labelling, safe use and disposal instructions and effective supply chain communication on PFAS, and identity and quantity information designed to allow downstream supply-chain compliance; with the labelling requirement for certain plastics proposed by the Dossier Submitters17 to be extended to cover all PFAS-containing substances, mixtures and articles placed on the market for derogated uses (with the exception of products manufactured from recovered / recycled materials and articles which were already in end-use in the Union), with the label to apply to all PFAS-containing products irrespective of whether PFAS are present as a result of impurities from the production process (e.g. use of polymerisation aids) or have been intentionally added;
- Site-specific PFAS management plans to be established by manufacturers and industrial users of PFAS and PFAS-containing mixtures, including information regarding the identity of PFAS used, a justification for their use and the results of monitoring activities to assess potential emissions into the environment; and
- Emission monitoring and reporting requirements for manufacturers, importers of PFAS or PFAS-containing mixtures or articles as well as industrial downstream users formulating PFAS-containing mixtures, that continue to manufacture, place on the market or use PFAS for 13.5 years or longer by way of a derogation, or for fluorinated-gas applications continued by way of a derogation.
Draft SEAC Opinion
Key points in which SEAC's draft opinion on the socio-economic proportionality of the Dossier Submitters' restriction proposal does not concur with RAC or the Dossier Submitters are set out below:
SEAC's recommended regulatory approach
SEAC considers the proposed restriction on PFAS to be the most appropriate EU-wide measure to address risks identified for PFAS emissions while taking into account the proportionality of its socio-economic benefits to its socio-economic costs, provided that the conditions are modified as proposed by SEAC. In line with the Dossier Submitters, SEAC supports a broad restriction with sector- or use-specific derogations, where costs outweigh the benefits of a complete ban. Specifically, SEAC endorses an approach based on a general concentration-limit-based ban combined with tailored, time-limited derogations for uses where the socio-economic case for continued use is demonstrated, accompanied by additional risk management measures. However, SEAC cannot conclude on the proportionality of the risk management measures recommended by RAC for derogated uses. Furthermore, due to significant remaining uncertainty, with the available data for a number of sectors not allowing SEAC to reach a definitive conclusion on the proportionality of the proposed restriction, SEAC emphasizes the need for further evaluation of those sectors.
Finding that the restriction as a whole, including appropriate derogations, is implementable, manageable and enforceable, although certain specific provisions may be more difficult to enforce, SEAC emphasises that the elaboration of appropriate guidance could help mitigate these enforceability concerns. Furthermore, SEAC considers an appropriate, practical and harmonised approach to enforcement at the EU/EEA level to be a prerequisite for ensuring enforceability.
Regulatory concern, grouping approach and general 18-month transition period
Having assessed the proposed restriction in the broader context of its socio-economic costs and benefits and taking RAC's risk assessment regarding risks for human health and the environment from PFAS into account, SEAC concludes that the risks identified for PFAS, including their transboundary movement and costs expected for environmental clean-up18, justify EU-wide regulatory action as well as the adoption of the grouping approach, with a general 18-month transition period.
Chemical scope of the restriction
SEAC supports RAC's conclusion that excluding certain PFAS subgroups as "fully degradable" is not justified. Requests by industry to exclude fluoropolymers from the scope of the restriction were also not accepted by SEAC.
Derogations
While SEAC acknowledges that an analysis of alternatives should form the basis for any discussion on derogations (and transition / derogation periods), the Committee generally disagrees with the identification of derogations solely based on the availability of technically and economically feasible alternatives. SEAC considers that a more comprehensive assessment of the associated emissions and the socio-economic impacts related to those derogations should be undertaken as well, i.e. including costs and benefits (i.e. avoided emissions as a proxy for risk reduction) associated with not implementing a specific derogation. Regarding the Dossier Submitters' determination of the appropriate transition / derogation period (18 months + 5 years or 18 months + 12 years), SEAC generally agrees on practical grounds, despite noting that the specific time frames (5 and 12 years) have been chosen rather arbitrarily.
Importantly, SEAC notes that any derogations considered justified should be regarded as necessary to ensure that a restriction is proportionate, but not as sufficient on their own. According to SEAC, additional derogations may be required for certain (sub-)uses for a restriction to be proportionate. However, uncertainties in the available information for the assessed (sub)uses, as well as unknown or unidentified (sub-)uses, prevent SEAC from specifying such additional derogations.
Overarching derogations
SEAC takes the following key positions on the overarching derogations proposed by the Dossier Submitters in paragraph 4 of their draft restriction text and supported in principle by RAC (with certain modifications):
- Active Substances in Regulated Products: The Dossier Submitters' proposal includes time-unlimited derogations for PFAS used as active substances in biocidal products, plant protection products, and human and veterinary medicinal products. SEAC finds that a time-unlimited derogation for these applications is not justified and is inconsistent with the rest of the restriction approach. Noting that the Dossier Submitters did not assess the impacts of a ban on these uses, SEAC is unable to conclude that the costs would outweigh the benefits. This is a significant finding for the pharmaceutical and agrochemical sectors, which can no longer rely on the time-unlimited derogation proposed by the Dossier Submitters as basis for continued protection.
- Spare Parts: The Dossier Submitters' proposal includes a derogation for spare parts intended to replace PFAS-containing articles in articles or complex objects for up to 20 years (or until end of service life if shorter), and a separate derogation for spare parts needed to meet legal obligations until end of service life. While agreeing that spare-part derogations are necessary and justified for certain uses to avoid premature obsolescence, SEAC cannot support the broad spare-parts derogation as proposed for the following reasons: The derogation is not tied to the non-availability of alternatives, there are definitional uncertainties regarding the distinction between spare parts and consumables, and the 20-year period is only partly justified. SEAC also supports the legal obligation spare-parts derogation as a pragmatic safeguard but calls for a clear definition of "spare parts" that excludes "consumables". Companies in the machinery, automotive, aerospace and industrial-equipment sectors should take note of this conclusion, as the derogation may not survive in its proposed form, and the scope of what qualifies as a "spare part" could narrow significantly in the final restriction.
- Product and Process Oriented Research and Development (PPORD): SEAC concludes that a generic PPORD derogation for all activities is not warranted, questioning its utility for uses subject to derogations of only five or 12 years. However, SEAC considers PPORD derogations justified where they are linked to time-unlimited derogations, to avoid a situation where PPORD would be prohibited while an underlying use remains derogated. Innovation-focused companies should pay close attention as PPORD activities for uses proposed to benefit from time-limited derogations may not be protected in the final restriction. In addition, stakeholders should consider how SEAC's position on PPORD intersects with its other findings: If a use does not benefit from a time-unlimited derogation (as now questioned by SEAC for active substances), the case for a generic PPORD carve-out becomes significantly weaker for that use.
- Recycling and Recovered Materials: The Dossier Submittters proposal includes derogations for certain paper and board, textile, and plastic articles containing recovered material (with specific exclusions), subject to proof-of-origin requirements, third-party certificates for imported articles, and specific labeling requirements for certain plastic streams. SEAC concludes that at entry into force of the restriction, the proposed concentration limits likely cannot be met for recycled plastics, recycled paper and board, and recycled textiles, and that a ban without derogation would cause significant negative impacts on recycling. Therefore, SEAC considers time-limited derogations for these materials justifiable, but it cannot conclude on the length of the derogation period needed. By contrast, SEAC finds that no recycling derogation is warranted for recycled metals, because the evidence indicates the concentration limits can be met at entry into force and no negative impacts on metal recycling are expected. As for the documentary proof-of-origin requirements for plastics, paper and board, and textiles, SEAC supports these, but raises concerns that the Dossier Submitters' draft derogation wording could enable circumvention. This is an important enforcement signal.
- PFAS Production Under Emission Limits: The Dossier Submitters' proposal includes a derogation allowing PFAS production under "controlled conditions" subject to specified emission-factor thresholds, with different thresholds applying before and after end-2030, and an additional threshold 6.5 years after entry into force. SEAC considers derogation for PFAS manufacturing with emission limits likely justified from a general standpoint, but it cannot conclude on the specific limits proposed by the Dossier Submitters and recommends that emission limits be technically and economically feasible and implementable. PFAS producers should treat the specific thresholds as subject to revision.
Derogations for the eight additional sectors (Printing, Sealing, Machinery, Other Medical Applications, Military, Explosives, Technical Textiles and Broader Industrial Uses)
For the eight additional sectors for which neither RAC nor SEAC carried out sector-specific evaluations, SEAC cannot conclude whether the Dossier Submitter's specific proposed derogations under draft paragraphs 5.cc through 5.ww and 6.p through 6.y of the Dossier Submitters' draft restriction text are justified, nor whether additional derogations for other uses / applications within these sectors would be justified. SEAC recommends that all uses and applications assessed by the Dossier Submitters in those sectors be evaluated as soon as possible. In the interim, SEAC recommends a time-limited derogation for all uses and applications within those sectors until the evaluation is completed and a proportionality decision can be made. This interim approach provides some short-term protection but introduces regulatory uncertainty for a broad range of industrial users.
Other sector-/use-specific derogations
Contrary to RAC, SEAC does not wholesale reject the Dossier Submitters' proposed sector-/use-specific derogations (cf. draft paragraphs 5 and 6). Rather, SEAC reaches differentiated conclusions, finding some derogations justified, partly justified, likely justified, justified from a general standpoint, could be justified, some not justified, and some requiring further evaluation.
For instance, SEAC:
- Finds a small number to be not justified as proposed, namely derogations for fluorinated gases (draft paragraphs 5e. through j.19), and for CERN20 (derogation in paragraph 5o.21).
- Finds a significant number of derogations under paragraphs 5 and 6 to be justified or likely justified (notably e.g. uses in PPE and their impregnation agents, most medical devices hard-chrome plating, additives to hydraulic fluids in transport vehicles, and several applications in energy electronics and semiconductors).
- Finds other derogations to be partly justified (PPE for certain risk categories, fluorinated gases as fire-suppression agents, certain insulating gases in high-voltage switchgear, hydraulic fluids in transport vehicles, packaging for medical devices, wires and cables (including connectors), insulation material of electronic components, and some uses in construction products).
- Cannot conclude on several further derogations due to data gaps (food contact materials and packaging, certain refrigerants in mobile air conditioning systems and heat pump systems in vehicles, gas and oil tracers, switchgear nozzles, photovoltaic backsheets, some energy uses, and fire safety additives in construction products).
SEAC also considered two additional 13.5-year derogations not proposed by the Dossier Submitter:
- A derogation for PVDF strings for musical instruments used by professional musicians is assessed as "could be justified", though SEAC could not evaluate the relevant costs due to lack of data and notes that the decision ultimately depends on policy priorities related to cultural value.
- A derogation for PFAS in radiofrequency equipment, waveguides and capacitors for 13.5 years is recommended by SEAC as "likely justified".
Derogation mechanics / risk management measures / conditions for derogated continued PFAS uses
SEAC's opinion also addresses three central conditions that should apply to any derogations, namely reporting obligations, site-specific PFAS management plans, and labeling and proof-of-origin requirements. SEAC notes and, in principle, supports RAC's recommendation to implement additional risk management measures to ensure PFAS emissions are minimised in case derogations are supported by the decision maker. However, SEAC raises proportionality and enforceability concerns across all three conditions and finds that it lacks the information necessary to assess the associated costs and benefits of these measures.
Reporting Obligations: The Dossier Submitters' proposal includes an annual reporting obligation starting 18 months after entry into force and due by 31 May each year, requiring manufacturers and importers of PFAS or PFAS-containing articles, and downstream users formulating PFAS-containing mixtures, to report to ECHA the derogation category and the identity and quantity of substances placed on the market in the previous year. ECHA would then share this information with the European Commission and Member States by 31 August. Separately, manufacturers and importers benefiting from the active-substance derogations would report to ECHA every two years on the derogation category and identity and quantity placed on the market, with ECHA publishing a summary.
SEAC considers reporting generally appropriate to monitor continued PFAS use and the effectiveness of the restriction but notes its limitations: tonnage data does not directly equate to emissions across diverse uses, and monitorability could be improved by including emissions information as recommended by RAC. In addition, SEAC lacks sufficient information to conclude on the proportionality of reporting requirements (particularly their costs versus benefits) and notes that reporting obligations have limited added value for uses with only a five-year derogation. Companies relying on derogations with shorter durations may therefore have grounds to argue against the full reporting burden. Stakeholders should raise any such arguments in the course of the consultation to inform SEAC's final conclusion and ensure that these considerations are reflected in SEAC's final opinion.
Site-Specific PFAS Management Plans: The Dossier Submitters proposed to require manufacturers, importers, and downstream users of fluoropolymers and perfluoropolyethers relying on derogations to establish a site-specific management plan covering the identity of substances and products used, the justification for their use, and the conditions of use and safe disposal, with the plan to be reviewed annually and made available to enforcement authorities upon request. SEAC considers the costs for fulfilling the proposed management plan requirement to be potentially significant and finds the requirement as proposed difficult to enforce and inappropriate or ineffective for supporting inspections and ensuring life-cycle assessment and risk management, even if guidance documents were to partially mitigate the enforceability concerns.
Regarding RAC's recommendation to expand management plans to all PFAS (not just fluoropolymers and perfluoropolyethers), with a focus on industrial uses with high emission potential, and requiring assessments of the technical feasibility of alternatives and monitoring results to be reported to ECHA, SEAC notes that this expanded approach would likely increase costs further and considers it difficult to enforce. SEAC cannot assess the proportionality of the expanded approach due to lack of data. SEAC's conclusion therefore renders the management plan requirement one of the more contested aspects of the restriction mechanics and one to monitor closely as the opinion is finalised.
Labelling, Proof-of-Origin and Supply-Chain Communication: For articles containing recovered materials, the proposal allows enforcement authorities to request documentary evidence to substantiate the recovered origin of materials, requires third-party traceability and recycled-content certificates for imported claims, and imposes a visible, legible, and indelible marking reading "Contains intentionally added PFASs" on certain plastic articles and complex objects containing intentionally added PFAS above the concentration limits, or on packaging where marking on the article itself is not possible.
SEAC supports the proof-of-origin requirements and considers the targeted labelling requirement useful for specific technical plastic streams, while viewing broader labelling for paper and board and textiles as offering little added value.
RAC's recommendation for extended labelling requirements, supply-chain communication measures for derogated uses, safe use and disposal instructions, and identity and quantity information designed to allow downstream supply-chain compliance (with exclusions for second-hand articles and recovered and recycled materials): SEAC supports, in principle, RAC's objective of additional risk management measures to minimise emissions where derogations remain, but raises enforceability concerns for several of RAC's proposed measures, including supply-chain communication and risk management measures for professional and consumer uses. SEAC lacks the information needed to assess the associated costs and benefits and cannot conclude whether RAC's measures are proportionate. However, SEAC considers RAC's general labelling requirement alerting to the presence of PFAS may be implementable and useful for awareness and supply-chain knowledge.
Key Takeaways
The scientific conclusions of RAC and the draft opinion of SEAC mark a major step toward EU-level restriction of PFAS. RAC, in its final opinion, and SEAC, in its draft opinion, support an EU-wide restriction, subject to specific derogations, on the manufacture, placing on the market and use of PFAS in the EU and EEA to address the growing and long‑lasting risks associated with PFAS to human health and the environment. Both Committees also recommend that any restriction should be complemented by effective measures to minimise emissions.
In light of the conclusions of the Committee, the forthcoming PFAS restriction will likely adopt a broad grouping approach, principally banning PFAS following a transitional period, with use-specific, time-limited derogations. This would, in principle, be in line with the EU Commission's European Chemicals Industry Action Plan and the Commission's commitment to stringent PFAS regulation as further demonstrated by the following PFAS-specific or -related measures: (1) prohibition of intentional use of PFAS in toys (2025)22, (2) restriction of PFAS in firefighting foams23 (2025), (3) prohibition of PFAS in or above certain concentration limits in food-contact packaging (2025),24 (4) restriction of a sub-group of PFAS in consumer textiles and footwear, food contact materials, consumer mixtures, and cosmetics as well as firefighting foams and firefighting foam concentrates25 (2024), and (5) PFAS-regulation under the EU Drinking Water Directive (2020).26
With ECHA's scientific committees' assessments of the restriction proposal well on their way, stakeholders face increasing urgency to submit their comments to SEAC. Further stakeholder input may still achieve additional amendments to the proposal, including to timelines and substantive derogations governing any continued uses, just as the input received in the initial public consultation in 2023 led to a significant revision of the Dossier Submitters' restriction proposal.
In addition to participating in the ongoing process and monitoring its development, businesses must prepare for compliance, even if details of the ultimate regulatory approach remain under development. At this stage, a ban on all PFAS with time-limited use-specific derogations will likely form part of the final restriction, supplemented by requirements, such as emission limits, information obligations, monitoring, labelling and reporting obligations. Overall, robust supply chain data and management (presupposing transparency, traceability and diligent upstream and downstream communication) will once again, as with REACH compliance management in general, be central to regulatory compliance management and strategic oversight. As a first step, businesses need to identify their exact PFAS uses to determine their exposure to the proposed restriction, and, as a second step, identify applicable potential derogations.
Proactive approaches to risk and compliance management – even absent replacement of PFAS with safer alternatives – are critical. The regulatory landscape is developing across the globe, rendering PFAS a cross-cutting matter with:
- increasing litigation and liability risks (e.g. product liability claims, inadequate disclosure or even greenwashing claims, environmental remediation costs, regulatory enforcement actions, and directors' and officers' liability), in particular if the proposed non-threshold treatment is accepted;
- emerging implications for insurers in terms of coverage, exclusions and underwriting considerations; as well as
- emerging implications for environmental permitting and emissions control.
1 COM(2020) 667 final 14 October 2020. The Chemicals Strategy for Sustainability, which aims to protect human health and the environment, promotes innovation for safe chemicals, and facilitates a transition to safer and more sustainable alternatives, laid the groundwork for regulatory initiatives to address PFAS.
2 European Commission on its European Chemicals Industry Action Plan, 8 July 2025, COM(2025)530, available at e5006955-dd1c-45bc-8b7a-cfda71c67abf_en.
3 European Commission on its European Chemicals Industry Action Plan, 8 July 2025, COM(2025)530, para 5.4 at p. 16 f., available at: e5006955-dd1c-45bc-8b7a-cfda71c67abf_en.
4 Water Directive and transposing Member State Laws (for Germany, see https://www.whitecase.com/insight-alert/new-standards-drinking-water-germany-new-limits-pfas); To 'cut sewage pollution in half by 2030' the UK Government seizes on the Cunliffe Report to restructure environmental law (see https://www.whitecase.com/insight-alert/cut-sewage-pollution-half-2030-government-seizes-cunliffe-report-restructure?s=pfas); EPA partially rolls back PFAS drinking water rule (see https://www.whitecase.com/insight-alert/epa-partially-rolls-back-pfas-drinking-water-rule?s=pfas); a PFAS product ban in France came into effect on 1 January 2026 for certain consumer product categories (cosmetics, clothing textiles (with specified exceptions) and ski waxes); a PFAS ban in Denmark for certain consumer products (clothing, footwear, medical devices and recycled items) with some derogations to come into force on 1 July 2026; reintroduction of the Forever Chemical Regulation and Accountability Act by U.S. Senator Durbin and Congresswoman McCollum in March 2026 to ban non-essential use of PFAS in products and expand reporting and recordkeeping requirements. See also European Commission January 2026 report "The cost of PFAS pollution for our society", available at: https://op.europa.eu/en/publication-detail/-/publication/2bcea765-fbf8-11f0-8da5-01aa75ed71a1/language-en.
5 OECD Report of 9 July 2021, Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practical Guidance (ENV/CBC/MONO(2021)25). PFAS within the scope of the restriction proposal are "[a]ny substances that contain at least one fully fluorinated methyl (CF3) or methylene (CF2) carbon atom (without H/Cl/Br/I attached to it)", excluding substances that only contain the following structural elements: CF3-X or X-CF2-X'. Therewith, the restriction proposal adopts a broad group-based chemical scope, capturing all non-polymeric and polymeric PFAS substances that are either persistent themselves or degrade to persistent PFAS, including fluoropolymers. The proposed restriction addresses all PFAS in scope, irrespective of whether they are substances on their own, constituents of another substance (including as an impurity or additive), or substances in mixtures or in articles. Overall, the chemical scope encompasses more than 10,000 PFAS substances, including a few fully degradable PFAS subgroups.
6 As used in the Background Document, the term „sector" refers to a group of (economic) activities and/or industrial areas in which PFAS are used in a similar way or related purposes across supply chains that is sufficiently recognizable to stakeholders. The sector is to be determined by the product's end use. Where applications of PFAS are used in many sectors in a similar way, e.g. in sealings, machinery, technical textiles, or application of fluorinated gases, they are covered as an overarching application applicable to several sectors (see Dossier Submitter's Summary of the revised restriction proposal: "What you need to know about the updated PFAS restriction dossier", 23 October 2025, at p. 5, available at: https://www.kemi.se/download/18.43415f2e19a0f60356220f8/1761224887540/What%20you%20need%20to%20know%20about%20the%20updated%20PFAS%20restriction%20dossier-Updated-2025-10-23-2.pdf).
7 Sector 1: PFAS manufacturing, Sector 2: TULAC (Textiles, upholstery, leather, apparel and carpets), Sector 3: Food contact materials and packaging, Sector 4: Metal plating and manufacture of metal products, Sector 5: Consumer mixtures and miscellaneous consumer articles, Sector 6: Cosmetics, Sector 7: Ski wax, Sector 8: Applications of fluorinated gases, Sector 9: Medical devices, Sector 10: Transport, Sector 11: Electronics and semiconductors, Sector 12: Energy, Sector 13: Construction products, Sector 14: Lubricant, and Sector 15: Petroleum and mining.
8 These newer eight sectors are: Sector 16: Printing applications, Sector 17: Sealing applications, Sector 18: Machinery applications, Sector 19: Other medical applications, Sector 20: Military applications, Sector 21: Explosives, Sector 22: Technical textiles, and Sector 23: Broader industrial uses.
9 RAC explicitly notes that many PFAS are highly mobile in the environment and have long-range transport potential. Combined with their high persistence, this leads to global drift of PFAS over long distances from the point of release.
10 RO2 meaning a ban on the manufacture, use, and placing on the market of PFAS in the EU and EEA with use-specific time-limited derogations (for the most part either a 6.5- or 13.5-year derogation period as of the entry into force of the proposed restriction), i.e. a 5- or 12-year derogation as of the coming into effect of the prohibition following an 18-month-transition period.
11 RAC concludes that a full ban as outlined by the Dossier Submitters in their restriction option ("RO") 1 could result in a 96% reduction of emissions, corresponds to approximately 3.3 million tons of avoided emissions over the 30 years (not taking into account certain potential emissions from continued use in e.g. spare parts, second-hand articles, recycled materials nor from active substances), while RO2 (ban with several derogations for specific uses) would reduce the effectiveness of the measure to 76% and result in additional emissions of approximately 700 000 tons over the assessment period compared to a full ban (RO1).
12 Meaning persistent, bioaccumulative ad toxic (PBT substances) as well as very persistent and very bioaccumulative (vPvB substances).
13 While RAC generally supports the Dossier Submitter's assessment of emissions, it makes a number of deviations, e.g. regarding fluoropolymers and calculating emissions with respect to certain waste management options and has developed its own approach to calculate emissions.
14 Where X = -OR or -NRR' and X' = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), -OR'', -SR'' or –NR''R'''; and where R/R'/R''/R''' is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-).
15 See Background Document, at p. 12. If total fluorine exceeds 50 mg F/kg, the manufacturer, importer or downstream user shall upon request provide to the enforcement authorities a proof for the fluorine measured as content of either PFAS or non-PFAS. The proof could be either supply chain information or based on analysis.
16 RAC expects emissions of an estimated 5900 tons over the assessment period in addition to the estimated RO1 emissions.
17 Proposed by the Dossier Submitters for plastic articles or complex objects falling under the scope of the Directive 2012/19/EU (WEEE Directive) or Directive 2000/53/EC (ELV Directive) as well as suppliers of PVC articles listed in paragraph 18 (a to f) of Regulation (EU) 2023/923 containing recovered materials.
18 See also European Commission January 2026 report "The cost of PFAS pollution for our society", available at: https://op.europa.eu/en/publication-detail/-/publication/2bcea765-fbf8-11f0-8da5-01aa75ed71a1/language-en.
19 SEAC finds draft derogations 5e (refrigerants in low-temperature refrigeration), 5f (refrigerants in laboratory test and measurement equipment), 5g (refrigerants in refrigerated centrifuges), 5h (refrigerants in HVACR equipment where national standards prohibit alternatives), 5i (foam blowing agents in thermal insulation foam), and 5j (propellants for technical aerosols) as proposed by the Dossier Submitters all "not justified", because they would create a conflict with measures already existing under the F-gas regulation. However, for each of these uses, SEAC recommends a derogation whose only goal is to avoid interfering with current and future prohibitions in F-gas regulation, and further recommends that the decision maker considers adding a time limit for otherwise time-unlimited exemptions from F-gas regulation, either in the ultimate PFAS restriction under REACH or F-gas regulation itself.
20 Meaning Conseil Européen pour la Recherche Nucléaire (European Council for Nuclear Research).
21 SEAC does not recommend a derogation because it would create a conflict with measures in the F-gas regulation. The Background Document indicates that the CERN uses fluorinated gases in hundreds of chillers and heat pumps. SEAC notes that chillers and heat pumps are covered by the F-gas regulation and several measures are in place to regulate the use of fluorinated gases in this equipment.
22 Annex II Part III point 5 of Regulation (EU) 2025/2509 of 26 November 2025 on the safety of toys and repealing Directive 2009/48/EC. It is to be noted, however, that restrictions or prohibitions on the use of PFAS under REACH or Regulation (EU) 2019/1021 shall take precedence over this generic prohibition of intentional use of PFAS in toys, components of toys or micro-structurally distinct parts of toys (see point 10 of Annex II Part III of Regulation (EU) 2025/2509).
23 Regulation (EU) 2025/1988 of 2 October 2025 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards per- and polyfluoroalkyl substances in firefighting foams.
24 Regulation (EU) 2025/40 of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC. Pursuant to Article 5 para. 5, this prohibition only applies to the extent that the placing on the market of packaging containing such a concentration of PFAS is not prohibited pursuant to another Union legal act, such as e.g. REACH.
25 Regulation (EU) 2024/2462 of 19 September 2024 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances.
26 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast). For implementation in Germany, see https://www.whitecase.com/insight-alert/new-standards-drinking-water-germany-new-limits-pfas.
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