Revision of EU PFAS restriction proposal – New method or continuity?, Markus Appel, Sebastian Meyn

PFAS (per- and polyfluoroalkyl substances), also known as “forever chemicals”, have just lately been topic to rising regulatory scrutiny and public consideration as a result of their persistence within the setting and potential well being dangers. The EU particularly has been taking steps to introduce a common PFAS restriction underneath the EU REACH Regulation (the EU’s central chemical regulation framework). After a prolonged interval 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, largely time-limited derogations and strict compliance necessities. 
• Essential makes use of, notably for industrial sectors, shall be permitted underneath proposed exemptions, whereas client functions will usually face stricter controls and shorter transition durations.
• Businesses ought to pay shut consideration to the particular substances, makes use of, and timeframes related to them. The coming months shall be important for sector enter, compliance planning, and provide chain engagement as the ultimate form of the EU’s PFAS framework is negotiated.
• The restriction proposal applies not solely to EU-based manufacturing but additionally to imported items. Non-EU corporations exporting PFAS-containing merchandise into Europe and the EEA might want to guarantee their merchandise stay marketable underneath the brand new guidelines by rigorously assessing compliance.

What occurred to date? 

The European Commission has recognized PFAS as a high-priority concern as a result of their excessive persistence, bioaccumulative properties, mobility, and potential toxicological results. These dangers have been highlighted within the 2020 Chemicals Strategy for Sustainability, which laid the groundwork for a significant regulatory initiative to handle PFAS.

In 2023 a proper restriction proposal on the idea of the EU REACH Regulation (the so-called “restriction dossier”) was submitted to ECHA by a number of Member States: Germany, the Netherlands, Sweden, Denmark, and Norway. This proposal underwent broad public session which resulted in additional than 5,600 stakeholder submissions. After almost two years of restricted communication, the restriction returned to the highlight via the EU’s Chemicals Action Plan (see our publication), which reaffirmed the aim of a complete PFAS ban and set a 2026 deadline for finalising ECHA’s analysis process.

The preliminary restriction file known as for a near-total ban on the manufacture, use, and inserting available on the market of PFAS within the EU and the European Economic Area (“EEA”), with considerably fewer derogations than within the present draft. After reviewing stakeholder feedback and assessing eight further impacted use sectors, the proposal has been revised and reissued as a “Background Document” for the restriction process. This doc shall be used to information the ECHA’s scientific committees in adopting their formal opinion on the restriction.

The regulatory method

The core purpose of the proposal is to ban the manufacture, use, and inserting available on the market of PFAS within the EU and EEA. This stays basically unchanged from the unique proposal. The revised  proposal, nevertheless, considerably expands the scope of exemptions through derogations from the ban. These refinements mirror the popularity of “essential uses” and sector-specific considerations, whereas sustaining the overarching aim of minimising PFAS emissions throughout the product lifecycle. Although the time period “essential use” isn’t explicitly talked about within the proposal’s predominant doc, the idea is implicitly mirrored all through its construction and annexes.

Beyond the overall manufacturing of PFAS, the Member States examined 22 distinct use sectors and their sub-uses. The proposal supplies for a variety of use-specific exemptions – many aligned with the definition of important makes use of, i.e., functions important to well being, security, or the correct functioning of society for which no appropriate options exist. Some of those exemptions might last as long as 12 years, balancing environmental safety with industrial feasibility.

When growing the PFAS restriction underneath EU REACH, Member States evaluated three predominant approaches (“restriction options” or ROs):

• RO 1: Full Ban – A blanket prohibition on the manufacture, use, and inserting available on the market of PFAS after an 18-month transition interval. Although environmentally efficient, this feature was deemed impractical because of the lack of short-term options in a number of sectors.
• RO 2: Ban with Use-Specific Derogations – The chosen method. This maintains the core ban however permits time-limited exemptions (5 or 12 years) for particular functions the place options are unavailable. In distinctive instances, limitless derogations are proposed the place substitution isn’t possible.
• RO 3: Conditional Use Under Strict Controls – This possibility permits PFAS use underneath stringent emission limits and was thought of for just a few sectors, reminiscent of electronics and semiconductors, following stakeholder enter.

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

The revised proposal would introduce a group-wide ban, treating all the group of PFAS as a single regulatory goal. This method, rooted within the precautionary precept, goals to stop “regrettable substitution” – the place one dangerous PFAS is changed with one other with related dangers. Considering the quantity and structural range of PFAS compounds, regulators concluded that solely a group-based restriction is workable.

Importantly, the proposal doesn’t override current bans or stricter rules on particular person PFAS (reminiscent of for PFOA or PFOS) or sure product classes (e.g., biocides, plant safety merchandise, medicinal merchandise). Rather, it enhances them by addressing the broader chemical household. The restriction covers an estimated 186,000 to 340,000 metric tonnes of PFAS positioned on the EEA market in 2020 alone. Without regulatory intervention, Member States estimate that roughly 27 million metric tonnes might be used inside the EEA by 2055.

A key conclusion of the proposal is that PFAS needs to be handled as “non-threshold substances” in danger evaluation – much like how the EU regulates persistent, bioaccumulative, and poisonous (PBT/vPvB) substances. This signifies that no reliably protected publicity degree may be established. Thus, even minimal releases could also be deemed to pose long-term dangers to well being and the setting, particularly given PFAS’s excessive persistence and mobility. This stance might have main implications for business, narrowing the scope for so-called “safe use” situations and implementing the necessity to minimise all emissions throughout the product lifecycle. In the context of PFAS danger evaluation, the emissions themselves, thus, function a proxy for danger – the extra PFAS launched, the better the chance of antagonistic results. This framing offers important weight to a precautionary method and, if adopted by the Commission, underscores the necessity for corporations to minimise all PFAS emissions.

Proposed restrictions intimately

The restriction proposal features a normal transition interval of 18 months from the restriction’s entry into pressure (unchanged from the unique proposal).

Core Ban and Thresholds

The proposal prohibits the manufacture, use, and inserting available on the market of PFAS as substances, in mixtures, and in articles. It introduces three focus thresholds relying on the analytical methodology used:

• 25 ppb for particular person PFAS (focused evaluation)
• 250 ppb for the sum of PFAS (with non-obligatory precursor degradation)
• 50 ppm for whole fluorine content material (together with polymeric PFAS)

Where validated strategies are unavailable, whole fluorine evaluation is used, with the burden on producers or importers to show whether or not the fluorine is or isn’t from PFAS. All three thresholds apply uniformly to any product, with exceedance permitted solely the place the product qualifies for a selected derogation set out within the draft restriction.

Transition Periods and Derogations

Numerous derogations are included for functions the place a use-specific substitution isn’t but possible. The preliminary 18-month grace interval is focused at makes use of the place options are anticipated to be viable within the quick time period (reminiscent of cosmetics, client mixtures, and ski wax). This grace interval additionally applies along with any particular derogation durations (that are added to the grace interval), together with limitless derogations, lots of which carry reporting or labelling obligations.

General derogations apply to merchandise no matter particular use, with closing dates and labelling necessities various on a case-by-case foundation. Key derogations embrace:

• PFAS manufacturing for exempted makes use of or export: Production allowed underneath strict emission limits, enabling continuity for important functions and export to non-EEA markets.
• Spare elements: Maintenance and restore elements for PFAS-containing gear profit from long-term or, in some instances, indefinite derogations, notably the place no PFAS-free options can be found.
• Second-hand merchandise: Articles already in use can proceed to be bought indefinitely.
• Recovered supplies: Recycled articles comprised of paper, textiles, or plastics are exempt underneath sure provisions (offered they don’t seem to be for meals contact or toys), and suppliers could also be required to doc and guarantee traceability via third-party certification.
• Research and growth: An indefinite derogation applies to product and process-oriented analysis and growth (PPORD), topic to case-by-case approval by ECHA. Scientific analysis is roofed by the overall EU REACH provisions.

Essential Uses and Sectoral Focus

About 50 important makes use of are thought of for derogation, primarily in industrial sectors. Fewer exemptions apply to client makes use of. Some derogations apply solely to fluoropolymers and perfluoropolyethers. These derogations are time-limited:

• For makes use of with a excessive medium-term substitution potential, a five-year derogation is granted – leading to a complete interval (together with the preliminary 18 months) of 6.5 years earlier than the ban applies.
• For makes use of with a low medium-term substitution potential, a 12-year derogation is granted – leading to a most of 13.5 years.

Products and sectors benefiting from derogations embrace, amongst others:

• medicinal merchandise and medical units
• fluorinated gases for refrigeration
• printing gear
• electronics
• filtration, sealing, and structural elements
• industrial equipment and sure makes use of in industrial processes

Semiconductor manufacturing and army functions each profit from broad normal derogations.

All derogations apply not solely to the PFAS serving the particular operate for which the exemption is granted but additionally to any upstream PFAS utilized in synthesising the ultimate product. PFAS utilized in gear or as course of chemical substances are additionally normally excluded, except particularly addressed.

While stakeholders requested formal overview clauses for sure derogations, the proposal depends on the Commission’s current authority underneath EU REACH to revise restrictions as applicable. Reviews by the Commission are deliberate earlier than the tip of derogation durations, notably the place substitution will possible stay unrealistic, reminiscent of for private protecting gear (PPE), batteries, semiconductors, fluorinated gases, and defence functions. Reporting obligations are supposed to permit the Commission to reassess ongoing want for a derogation.

Reporting and Management Obligations

Companies that profit from derogations – together with producers, importers, and ”formulators” of PFAS – shall be required to adjust to annual reporting necessities, detailing the id and portions of PFAS used. Further, for the usage of fluoropolymers (FP) and perfluoropolyethers (PFE), site-specific administration plans have to be ready and maintained, protecting use situations, disposal, and justification for continued use. The proposal acknowledges challenges in provide chain communication and requires suppliers to reveal PFAS content material. It assumes that corporations should set up efficient chemical administration methods to hint PFAS all through the worth chain. Accountability falls on these closest to the purpose of market entry. The proposal additionally identifies “formulators” – the primary downstream customers to introduce PFAS into merchandise – as chargeable for compliance with PFAS-related derogations.

Roadmap – what occurs subsequent?

ECHA’s Risk Assessment Committee (“RAC”) and Socio-Economic Analysis Committee (“SEAC”) are reviewing the proposal in batches, specializing in the sectors assessed within the unique proposal – which incorporates textiles, electronics, medical units, steel plating, PFAS manufacturing, and cross-sectoral points. For the eight added sectors within the new “background document” offered by the Member States, ECHA won’t conduct particular person evaluations as a result of schedule constraints. It stays unclear to what extent the derogations for these new sectors shall be reviewed. Stakeholders in these sectors might subsequently want to remark throughout RAC’s scheduled discussions on the restriction’s horizontal (i.e., cross-sector) points, which proceed all year long. RAC’s closing and SEAC’s draft opinions shall be revealed on ECHA’s web site, with stakeholders given 60 days to submit feedback on SEAC’s draft.

The proposal stays underneath energetic growth: the committees’ opinions will assist inform the Commission, which in flip will draft the ultimate restriction proposal. This interval gives corporations a important alternative to boost considerations or present new information. The SEAC should take into account suggestions from business, NGOs, and Member States, and amendments to the scope or derogations are nonetheless potential. Notably, the enter from the preliminary public session has already led to substantial modifications within the Member States’ revised proposal within the new “background document”. Active participation within the course of might assist form the ultimate final result.

On 27 August 2025, ECHA confirmed its “firm objective” to ship the ultimate RAC and SEAC opinions to the Commission in 2026 (see here). Once these are acquired, the Commission will publish a draft modification to Annex XVII of the EU REACH Regulation, which can element the particular substance restrictions. The Commission can even take into account the up to date proposal submitted by the Member States, notably because it pertains to the eight newly coated sectors. The Commission should draft its personal restriction in gentle of all out there proof and enter (together with the Member State proposals). Thus, even at this stage, additional changes are potential. Political deliberations, commerce issues, and enforcement realities might all influence the ultimate textual content. Businesses ought to stay vigilant for updates and put together for a number of situations. The Commission’s draft shall be submitted to the World Trade Organisation (WTO) to make sure worldwide commerce compliance. 

The European Parliament and Council will normally have 2 months to formally object to the Commission proposal (the “objection period”), which may be prolonged (normally by an additional two months). If no objections are raised by the co-legislators throughout the objection interval, the restriction proposal is formally adopted and revealed within the Official Journal of the EU. 

The Commission’s dedication to strong PFAS regulation has already been demonstrated in its latest restriction of PFAS in firefighting foams. New guidelines launched by the Commission impose a broad ban on beforehand unregulated PFAS in foam formulations, with a strict focus restrict (1 mg/litre) and obligatory site-specific administration plans. Extended transition durations for defence, maritime, and offshore oil and gasoline sectors mirrored each technical challenges and the drive for substitution. The regulation accepted estimated socio-economic prices over 30 years of seven billion euros, justified by the environmental and well being advantages of stopping 13,000 metric tonnes of PFAS emissions. This units a precedent for formidable regulation, even in difficult industrial contexts.

What does this imply for enterprise?

Companies manufacturing, importing, or utilizing PFAS within the EU or EEA should intently monitor the progress of the restriction proposal and put together for compliance. The proposal contains measures starting from a full ban to use-specific derogations and potential “safe use” situations, every with various transition durations and compliance obligations. Annual utilization studies and web site administration plans will possible grow to be obligatory for a lot of companies.

This complete method demonstrates the EU’s intent to control PFAS throughout all the lifecycle – from manufacturing via use to disposal. The shift indicators stricter enforcement and emphasises the significance of strong provide chain oversight. Given public statements by the Commission and ECHA, a elementary ban is nearly sure to stay a part of the ultimate guidelines, even when the small print on particular derogations proceed to evolve.

The 2026 deadline for scientific evaluation gives a considerably predictable timeline for compliance preparation. Notably, the restriction applies not solely to EU-based manufacturing but additionally to imported items. Non-EU corporations exporting PFAS-containing merchandise into Europe and the EEA might want to guarantee their merchandise stay marketable underneath the brand new guidelines by rigorously assessing compliance. The proposal’s enforceable focus thresholds and reporting obligations make provide chain transparency and traceability important.

Our EU-based environmental regulation staff continues to watch regulatory developments and advise shoppers on strategic regulatory planning and future compliance.