Revision of EU PFAS restriction proposal – New approach or continuity?

PFAS (per- and polyfluoroalkyl substances), often referred to as “forever chemicals”, have recently been subject to increasing regulatory scrutiny and public attention due to their persistence in the environment and potential health risks. The EU in particular has been taking steps to introduce a universal PFAS restriction under the EU REACH Regulation (the EU’s central chemical regulation framework). After a lengthy period with little official communication, a revised restriction proposal has been submitted by Member States on 24 June 2025 and was published by the European Chemicals Agency (“ECHA”) on 20 August 2025.

Key takeaways

• The restriction proposal introduces a broad prohibition on PFAS, with detailed, mostly time-limited derogations and strict compliance requirements. 
• Essential uses, particularly for industrial sectors, will be permitted under proposed exemptions, while consumer applications will generally face stricter controls and shorter transition periods.
• Businesses should pay close attention to the specific substances, uses, and timeframes relevant to them. The coming months will be critical for sector input, compliance planning, and supply chain engagement as the final shape of the EU’s PFAS framework is negotiated.
• The restriction proposal applies not only to EU-based manufacturing but also to imported goods. Non-EU companies exporting PFAS-containing products into Europe and the EEA will need to ensure their products remain marketable under the new rules by carefully assessing compliance.

What happened so far? 

The European Commission has identified PFAS as a high-priority concern due to their extreme persistence, bioaccumulative properties, mobility, and potential toxicological effects. These risks were highlighted in the 2020 Chemicals Strategy for Sustainability, which laid the groundwork for a major regulatory initiative to address PFAS.

In 2023 a formal restriction proposal on the basis of the EU REACH Regulation (the so-called “restriction dossier”) was submitted to ECHA by several Member States: Germany, the Netherlands, Sweden, Denmark, and Norway. This proposal underwent broad public consultation which resulted in more than 5,600 stakeholder submissions. After nearly two years of limited communication, the restriction returned to the spotlight through the EU’s Chemicals Action Plan (see our publication), which reaffirmed the goal of a comprehensive PFAS ban and set a 2026 deadline for finalising ECHA’s evaluation procedure.

The initial restriction dossier called for a near-total ban on the manufacture, use, and placing on the market of PFAS in the EU and the European Economic Area (“EEA”), with significantly fewer derogations than in the current draft. After reviewing stakeholder comments and assessing eight additional impacted use sectors, the proposal has been revised and reissued as a “Background Document” for the restriction procedure. This document will be used to guide the ECHA’s scientific committees in adopting their formal opinion on the restriction.

The regulatory approach

The core aim of the proposal is to ban the manufacture, use, and placing on the market of PFAS in the EU and EEA. This remains fundamentally unchanged from the original proposal. The revised  proposal, however, significantly expands the scope of exemptions via derogations from the ban. These refinements reflect the recognition of “essential uses” and sector-specific concerns, while maintaining the overarching goal of minimising PFAS emissions across the product lifecycle. Although the term “essential use” is not explicitly mentioned in the proposal’s main document, the concept is implicitly reflected throughout its structure and annexes.

Beyond the general production of PFAS, the Member States examined 22 distinct use sectors and their sub-uses. The proposal provides for a range of use-specific exemptions – many aligned with the definition of essential uses, i.e., applications critical to health, safety, or the proper functioning of society for which no suitable alternatives exist. Some of these exemptions may last up to 12 years, balancing environmental protection with industrial feasibility.

When developing the PFAS restriction under EU REACH, Member States evaluated three main approaches (“restriction options” or ROs):

• RO 1: Full Ban – A blanket prohibition on the manufacture, use, and placing on the market of PFAS after an 18-month transition period. Although environmentally effective, this option was deemed impractical due to the lack of short-term alternatives in several sectors.
• RO 2: Ban with Use-Specific Derogations – The selected approach. This maintains the core ban but allows time-limited exemptions (five or 12 years) for specific applications where alternatives are unavailable. In exceptional cases, unlimited derogations are proposed where substitution is not feasible.
• RO 3: Conditional Use Under Strict Controls – This option allows PFAS use under stringent emission limits and was considered for a few sectors, such as electronics and semiconductors, following stakeholder input.

Ultimately, RO 2 was chosen as the most balanced option, combining environmental ambition with industrial feasibility and enforceability.

The revised proposal would introduce a group-wide ban, treating the entire group of PFAS as a single regulatory target. This approach, rooted in the precautionary principle, aims to prevent “regrettable substitution” – where one harmful PFAS is replaced with another with similar risks. Considering the number and structural diversity of PFAS compounds, regulators concluded that only a group-based restriction is workable.

Importantly, the proposal does not override existing bans or stricter regulations on individual PFAS (such as for PFOA or PFOS) or certain product categories (e.g., biocides, plant protection products, medicinal products). Rather, it complements them by addressing the broader chemical family. The restriction covers an estimated 186,000 to 340,000 metric tonnes of PFAS placed on the EEA market in 2020 alone. Without regulatory intervention, Member States estimate that approximately 27 million metric tonnes could be used within the EEA by 2055.

A key conclusion of the proposal is that PFAS should be treated as “non-threshold substances” in risk assessment – similar to how the EU regulates persistent, bioaccumulative, and toxic (PBT/vPvB) substances. This means that no reliably safe exposure level can be established. Thus, even minimal releases may be deemed to pose long-term risks to health and the environment, especially given PFAS’s extreme persistence and mobility. This stance could have major implications for industry, narrowing the scope for so-called “safe use” scenarios and enforcing the need to minimise all emissions across the product lifecycle. In the context of PFAS risk assessment, the emissions themselves, thus, serve as a proxy for risk – the more PFAS released, the greater the likelihood of adverse effects. This framing gives significant weight to a precautionary approach and, if adopted by the Commission, underscores the need for companies to minimise all PFAS emissions.

Proposed restrictions in detail

The restriction proposal includes a general transition period of 18 months from the restriction’s entry into force (unchanged from the original proposal).

Core Ban and Thresholds

The proposal prohibits the manufacture, use, and placing on the market of PFAS as substances, in mixtures, and in articles. It introduces three concentration thresholds depending on the analytical method used:

• 25 ppb for individual PFAS (targeted analysis)
• 250 ppb for the sum of PFAS (with optional precursor degradation)
• 50 ppm for total fluorine content (including polymeric PFAS)

Where validated methods are unavailable, total fluorine analysis is used, with the burden on manufacturers or importers to prove whether the fluorine is or is not from PFAS. All three thresholds apply uniformly to any product, with exceedance permitted only where the product qualifies for a specific derogation set out in the draft restriction.

Transition Periods and Derogations

Numerous derogations are included for applications where a use-specific substitution is not yet feasible. The initial 18-month grace period is targeted at uses where alternatives are expected to be viable in the short term (such as cosmetics, consumer mixtures, and ski wax). This grace period also applies in addition to any specific derogation periods (which are added to the grace period), including unlimited derogations, many of which carry reporting or labelling obligations.

General derogations apply to products regardless of specific use, with time limits and labelling requirements varying on a case-by-case basis. Key derogations include:

• PFAS manufacturing for exempted uses or export: Production allowed under strict emission limits, enabling continuity for critical applications and export to non-EEA markets.
• Spare parts: Maintenance and repair parts for PFAS-containing equipment benefit from long-term or, in some cases, indefinite derogations, particularly where no PFAS-free alternatives are available.
• Second-hand products: Articles already in use can continue to be sold indefinitely.
• Recovered materials: Recycled articles made from paper, textiles, or plastics are exempt under certain provisions (provided they are not for food contact or toys), and suppliers may be required to document and ensure traceability through third-party certification.
• Research and development: An indefinite derogation applies to product and process-oriented research and development (PPORD), subject to case-by-case approval by ECHA. Scientific research is covered by the general EU REACH provisions.

Essential Uses and Sectoral Focus

About 50 essential uses are considered for derogation, primarily in industrial sectors. Fewer exemptions apply to consumer uses. Some derogations apply only to fluoropolymers and perfluoropolyethers. These derogations are time-limited:

• For uses with a high medium-term substitution potential, a five-year derogation is granted – resulting in a total period (including the initial 18 months) of 6.5 years before the ban applies.
• For uses with a low medium-term substitution potential, a 12-year derogation is granted – resulting in a maximum of 13.5 years.

Products and sectors benefiting from derogations include, among others:

• medicinal products and medical devices
• fluorinated gases for refrigeration
• printing equipment
• electronics
• filtration, sealing, and structural components
• industrial machinery and certain uses in industrial processes

Semiconductor manufacturing and military applications both benefit from broad general derogations.

All derogations apply not only to the PFAS serving the specific function for which the exemption is granted but also to any upstream PFAS used in synthesising the final product. PFAS used in equipment or as process chemicals are also usually excluded, unless specifically addressed.

While stakeholders requested formal review clauses for certain derogations, the proposal relies on the Commission’s existing authority under EU REACH to revise restrictions as appropriate. Reviews by the Commission are planned before the end of derogation periods, particularly where substitution will likely remain unrealistic, such as for personal protective equipment (PPE), batteries, semiconductors, fluorinated gases, and defence applications. Reporting obligations are intended to allow the Commission to reassess ongoing need for a derogation.

Reporting and Management Obligations

Companies that benefit from derogations – including manufacturers, importers, and ”formulators” of PFAS – will be required to comply with annual reporting requirements, detailing the identity and quantities of PFAS used. Further, for the use of fluoropolymers (FP) and perfluoropolyethers (PFE), site-specific management plans must be prepared and maintained, covering use conditions, disposal, and justification for continued use. The proposal acknowledges challenges in supply chain communication and requires suppliers to disclose PFAS content. It assumes that companies must establish effective chemical management systems to trace PFAS throughout the value chain. Accountability falls on those closest to the point of market entry. The proposal also identifies “formulators” – the first downstream users to introduce PFAS into products – as responsible for compliance with PFAS-related derogations.

Roadmap – what happens next?

ECHA’s Risk Assessment Committee (“RAC”) and Socio-Economic Analysis Committee (“SEAC”) are reviewing the proposal in batches, focusing on the sectors assessed in the original proposal – which includes textiles, electronics, medical devices, metal plating, PFAS manufacturing, and cross-sectoral issues. For the eight added sectors in the new “background document” provided by the Member States, ECHA will not conduct individual evaluations due to schedule constraints. It remains unclear to what extent the derogations for these new sectors will be reviewed. Stakeholders in these sectors may therefore wish to comment during RAC’s scheduled discussions on the restriction’s horizontal (i.e., cross-sector) issues, which continue throughout the year. RAC’s final and SEAC’s draft opinions will be published on ECHA’s website, with stakeholders given 60 days to submit comments on SEAC’s draft.

The proposal remains under active development: the committees’ opinions will help inform the Commission, which in turn will draft the final restriction proposal. This period offers companies a critical opportunity to raise concerns or provide new data. The SEAC must consider feedback from industry, NGOs, and Member States, and amendments to the scope or derogations are still possible. Notably, the input from the initial public consultation has already led to substantial changes in the Member States’ revised proposal in the new “background document”. Active participation in the process may help shape the final outcome.

On 27 August 2025, ECHA confirmed its “firm objective” to deliver the final RAC and SEAC opinions to the Commission in 2026 (see here). Once these are received, the Commission will publish a draft amendment to Annex XVII of the EU REACH Regulation, which will detail the specific substance restrictions. The Commission will also consider the updated proposal submitted by the Member States, particularly as it relates to the eight newly covered sectors. The Commission must draft its own restriction in light of all available evidence and input (including the Member State proposals). Thus, even at this stage, further adjustments are possible. Political deliberations, trade considerations, and enforcement realities may all impact the final text. Businesses should remain vigilant for updates and prepare for multiple scenarios. The Commission’s draft will be submitted to the World Trade Organisation (WTO) to ensure international trade compliance. 

The European Parliament and Council will usually have 2 months to formally object to the Commission proposal (the “objection period”), which can be extended (usually by a further two months). If no objections are raised by the co-legislators during the objection period, the restriction proposal is formally adopted and published in the Official Journal of the EU. 

The Commission’s commitment to robust PFAS regulation has already been demonstrated in its recent restriction of PFAS in firefighting foams. New rules introduced by the Commission impose a broad ban on previously unregulated PFAS in foam formulations, with a strict concentration limit (1 mg/litre) and mandatory site-specific management plans. Extended transition periods for defence, maritime, and offshore oil and gas sectors reflected both technical challenges and the drive for substitution. The regulation accepted estimated socio-economic costs over 30 years of seven billion euros, justified by the environmental and health benefits of preventing 13,000 metric tonnes of PFAS emissions. This sets a precedent for ambitious regulation, even in challenging industrial contexts.

What does this mean for business?

Companies manufacturing, importing, or using PFAS in the EU or EEA must closely monitor the progress of the restriction proposal and prepare for compliance. The proposal includes measures ranging from a full ban to use-specific derogations and potential “safe use” scenarios, each with varying transition periods and compliance obligations. Annual usage reports and site management plans will likely become mandatory for many businesses.

This comprehensive approach demonstrates the EU’s intent to regulate PFAS across the entire lifecycle – from production through use to disposal. The shift signals stricter enforcement and emphasises the importance of robust supply chain oversight. Given public statements by the Commission and ECHA, a fundamental ban is almost certain to remain part of the final rules, even if the details on specific derogations continue to evolve.

The 2026 deadline for scientific assessment offers a somewhat predictable timeline for compliance preparation. Notably, the restriction applies not only to EU-based manufacturing but also to imported goods. Non-EU companies exporting PFAS-containing products into Europe and the EEA will need to ensure their products remain marketable under the new rules by carefully assessing compliance. The proposal’s enforceable concentration thresholds and reporting obligations make supply chain transparency and traceability essential.

Our EU-based environmental law team continues to monitor regulatory developments and advise clients on strategic regulatory planning and future compliance.