The proposed universal restriction on per- and polyfluoroalkyl substances under REACH is the largest chemicals restriction dossier ever submitted to the European Chemicals Agency, measured both by the number of substances in scope and the range of industries affected. For companies whose products, processes, or supply chains involve PFAS in any form, the practical questions are now about sequencing: what needs to be assessed, what decisions can still be shaped, and where the real exposure sits. Lirk Nor works with regulatory affairs, product compliance, and advocacy teams across the EU and UK to work through those questions in a structured way.
How PFAS is defined under the proposed EU restriction
The Annex XV restriction dossier, submitted in January 2023 by the competent authorities of Germany, the Netherlands, Denmark, Sweden, and Norway, adopts a structural definition derived from OECD guidance. A substance qualifies as a PFAS if it contains at least one fully fluorinated methyl carbon atom (CF₃) or at least one fully fluorinated methylene carbon atom (CF₂), unless all fluorinated carbons in the molecule are bonded exclusively to hydrogen, chlorine, bromine, or iodine. The definition is deliberately broad, designed to capture the entire family of substances that share the persistent carbon-fluorine bond, without enumerating a named list.
In practical terms, this goes well beyond PFOA, PFOS, or PFHxA. It captures fluoropolymers used in semiconductor manufacturing and medical devices, side-chain fluorinated polymers in textiles and paper coatings, fluorinated gases used as refrigerants and in electronics fabrication, and a long tail of fluorinated intermediates and processing aids that often do not appear on a company's substance inventory under any PFAS designation. The EU approach is also considerably broader than the regulatory frameworks used elsewhere. In the United States, federal and state approaches have generally focused on subsets of the family, and assuming that compliance under one system implies compliance under the other is a significant risk for companies operating across both markets.
The United Kingdom is developing its own approach under UK REACH, with the Health and Safety Executive's regulatory management options analysis signalling a likely narrower initial scope, concentrated on consumer applications and selected industrial uses. The divergence between the EU and UK trajectories is itself a question that needs active management for any company placing products on both markets.
The regulatory timeline
The Annex XV dossier was formally submitted to ECHA on 13 January 2023, followed by a six-month public consultation that closed in September of that year. Since then, the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) have been working through the dossier sector by sector, covering consumer mixtures, cosmetics, food contact materials, medical devices, fluorinated gases, transport, electronics, energy, lubricants, fluoropolymers, and fluoroelastomers, among others.
On 3 March 2026, RAC adopted its final opinion, concluding that a group-wide restriction is warranted on the basis of PFAS persistence, mobility, and the risks they present to human health and the environment. SEAC published its draft opinion on the same date, supporting an EU-wide restriction subject to specific, time-limited exemptions. A sixty-day public consultation on the SEAC draft opinion closed on 25 May 2026, and SEAC is expected to adopt its final opinion by the end of 2026. Once both committee opinions are transmitted to the European Commission, the Commission will prepare a draft amendment to Annex XVII of REACH, subject to examination by the REACH Committee of Member State representatives and subsequent scrutiny by the European Parliament and Council. The general baseline under the current proposal is a prohibition applying eighteen months from entry into force, with longer transitional periods for derogated uses, running to five, twelve, or in some cases more than twelve years.
This central dossier is surrounded by a body of adjacent measures that create additional pressure on their own timelines. The restriction on PFHxA and its salts is already entering into force in stages. The recast Drinking Water Directive introduces sum parameters for PFAS that are working their way into utility procurement requirements. Food contact material rules are under active Commission review. Harmonised classifications under Reg. (EC) No 1272/2008 (CLP) continue to be proposed for individual PFAS, and the POPs Regulation keeps pace as additional substances are listed under the Stockholm Convention.
What this means in practice
The implications look different depending on where a company sits in the supply chain and which sectors it operates in.
A fluoropolymer producer is dealing with fundamental questions about the long-term shape of its portfolio, set against the technical and safety case the industry has developed around the polymer of low concern framework and the derogation evidence presented to RAC and SEAC. A textile finisher using side-chain fluorinated polymers for water and oil repellency faces a different set of pressures: credible non-fluorinated alternatives exist for some applications but not all, and brand-level commitments from downstream customers frequently run ahead of the regulatory deadlines. A semiconductor manufacturer relying on fluorinated gases and fluoropolymer components in cleanroom processes has to reconcile a European restriction timeline with globally integrated supply chains and qualification cycles that can span years. A medical device company is in a more constrained position still, because any change to a fluoropolymer component may require requalification under the Medical Device Regulation (EU) 2017/745 (MDR), a process that can take considerably longer than a standard restriction transitional period would allow. Each of these situations calls for a different response, and the first thing worth establishing is which one actually applies to a given business.
How Lirk Nor supports your PFAS strategy
Portfolio and exposure assessment
Before strategy questions can be answered, exposure needs to be understood precisely. Most assessments surface substances that were not on the company's radar, particularly in processing aids and upstream supply chain inputs.
- PFAS portfolio screening across product lines, raw materials, articles, and formulations
- Upstream supply chain mapping to identify exposure beyond direct substance use
- Distinction between intentionally added PFAS, impurities, and processing aids
- Substance assessment against both the proposed EU definition and the narrower UK REACH scope
- Tonnage band analysis and use mapping under the ECHA use descriptor system
- Article 33 REACH communication readiness for PFAS already listed as substances of very high concern
Regulatory intelligence and monitoring
The volume of PFAS-related regulatory activity across multiple tracks makes it genuinely difficult to stay across what is relevant for a specific sector and portfolio. The monitoring service is designed to filter that down to what actually matters for your business.
- Sector-by-sector tracking of RAC and SEAC opinion progression
- Monitoring of adjacent dossiers, including PFHxA, firefighting foams, food contact materials, drinking water, and cosmetics
- Parallel tracking of UK REACH developments alongside the EU process
- Member State implementation monitoring once the restriction enters into force
- Sector-specific briefings filtered to what is relevant for your portfolio
Strategic response in the post-consultation phase
With the SEAC consultation closed and the final opinion expected by the end of 2026, attention is turning to the Commission's drafting of the restriction proposal and the comitology procedure that follows. The work at this stage is about understanding what RAC and SEAC have actually concluded and translating that into engagement where it still counts.
- Analysis of the adopted RAC opinion and the draft and final SEAC opinions, with implications mapped to your portfolio
- Engagement strategy for the Commission's preparation of the implementing act
- Member State-level engagement ahead of REACH Committee discussions
- Positioning for European Parliament and Council scrutiny
- Preparation for the transitional period and any review clauses built into the final restriction
Alternatives assessment
The strength of any derogation case depends on the rigour with which alternatives have been examined. Where substitution is not yet feasible, that conclusion needs to be documented in a form that holds up under regulatory scrutiny.
- Technical alternatives screening, including non-fluorinated chemistries and design changes
- Performance benchmarking against incumbent PFAS-based solutions under realistic operating conditions
- Regulatory status check on candidate alternatives, since several carry their own liabilities under REACH or CLP
- Transition roadmap development with phased substitution planning
- Documented no-alternative-available positions where this is the operational reality
Advocacy and stakeholder engagement
Technical positions need to reach the right people at the right point in the process. With the formal ECHA consultation phase closed, the relevant forums are now the Commission services, the REACH Committee, and the European Parliament's scrutiny process. Through the partnership with Kreab Brussels, Lirk Nor combines the regulatory substance with the political engagement that those forums require.
- Position paper drafting for ongoing engagement with Commission services and Member States
- Political engagement at Commission, Parliament, and Member State level via expert Partners
- Stakeholder mapping across DG GROW, DG Environment, ECHA, and national competent authorities
- Workshop facilitation between technical and regulatory teams to align internal positions
- External communications support on PFAS positioning
Compliance preparation and operational readiness
An eighteen-month transitional period sounds reasonable in the abstract. Set against supplier qualification cycles, contractual revisions, and product requalification requirements, it frequently is not. Operational readiness planning is worth starting well before the restriction text is finalised.
- Transition planning for the eighteen-month and longer transitional periods
- Supplier engagement protocols and contractual clauses for PFAS phase-out
- Customer communication frameworks for downstream users
- Internal training programmes for regulatory affairs, product compliance, and procurement teams
- Integration with existing REACH registration, CLP labelling, and SCIP database obligations
Adjacent regulatory dossiers
The universal restriction is the largest single piece of the picture, but the surrounding regulatory landscape for PFAS is dense, and the cumulative effect of the adjacent measures is substantial for many businesses.
- PFAS in food contact materials under Reg. (EC) No 1935/2004 and the ongoing Commission review
- Drinking water directive sum parameters and their supply chain implications
- Cosmetics regulation restrictions on individual PFAS
- Industrial emissions directive and the relevant best available techniques conclusions
- Waste framework directive and the POPs regulation overlap governing PFAS in waste streams
Get in touch with LIRK NOR
Every company touched by PFAS is at a different point in its response. Some are still mapping where exposure actually sits. Others have a clear picture of their portfolio and are working through the derogation versus substitution question. Others are past that decision and focused on the operational side of transition. Wherever that is for your business, the useful starting point is usually a short conversation to identify the two or three questions that most need answering and in what order. To discuss how LIRK NOR can support your PFAS strategy, please get in touch.