In what could become one of the most far-reaching chemical bans in EU history, five European States — Denmark, Sweden, Norway, Finland, and Germany — have jointly proposed restricting more than 10,000 per- and polyfluoroalkyl substances ("PFAS") under the Regulation 1907/2006 ("REACH"). While the intention to protect human health and the environment is clear, the proposal—submitted in March 2023—is drawing increasing criticism.
More than two years into its evaluation, the draft restriction remains under review by ECHA's Risk Assessment ("RAC") and Socio-Economic Assessment Committees ("SEAC"), with only ECHA's combined SEAC and RAC opinion expected throughout 2025. Any binding measures would still require the European Commission to formally amend Annex XVII of REACH.
Legal Flaws of the Proposal
At the heart of the concern is the proposal's scope, defined through a broad structural grouping based on the presence of fully fluorinated methyl or methylene groups—closely resembling the non-binding 2021 OECD definition. This definition omits standard chemical identifiers (such as CAS or EC numbers), which are typically required for regulatory clarity and enforceability. Critics argue that this "one-size-fits-all" approach presumes uniform hazard and risk across thousands of chemically diverse PFAS substances—an assumption that even ECHA's RAC has acknowledged is scientifically questionable.
This approach raises fundamental issues of enforceability, proportionality, and legal certainty—core principles under Annex XV of REACH. The hazard assessment relies heavily on generalised claims of persistence and extrapolation from a few well-known substances, such as PFOA and PFOS, to thousands of distinct PFAS compounds, often without substance-specific data. The dossier also overlooks critical gaps in exposure and emissions data, particularly during waste treatment and article use phases, and provides only a superficial analysis of actual use patterns across sectors.
The restriction's justification is largely based on persistence alone, without sufficiently demonstrating concurrent toxicity or mobility—criteria that typically underpin restrictions under REACH. This legal basis is debatable and may not withstand judicial review. Moreover, the assessment of alternatives is incomplete and lacks quantitative analysis, raising concerns about the real-world feasibility of substitution across all sectors.
Additionally, the proposal pays limited attention to existing regulatory instruments (such as the POPs Regulation, F-gas Regulation, and the Stockholm Convention), increasing the risk of regulatory overlap. Its broad scope and untested definitions also undermine the ability to measure effectiveness or track compliance. The process of granting derogations appears opaque and inconsistent, with some sectors receiving temporary exemptions and others excluded without clear justification. These accumulated deficiencies suggest that, as currently drafted, the proposal may fall short of delivering proportionate, effective, and legally robust outcomes.
Interactions with the REACH Revision
It is also important to note that the REACH Regulation itself is currently undergoing revision as part of the broader Chemicals Industry Package, expected in the last quarter of 2025. This was confirmed during the 54th meeting of the Competent Authorities for REACH and CLP ("CARACAL") held in April 2024. The upcoming overhaul is set to introduce major changes across several regulatory pillars, including enforcement, restriction, supply chain communication, evaluation, registration, nanomaterials, and authorisation.
These anticipated reforms add a layer of regulatory uncertainty for the PFAS restriction. Any changes to REACH's foundational framework could directly affect how group-based restrictions are defined, justified, and enforced—casting further doubt on the proposal's long-term legal and operational viability.
What Comes Next?
The PFAS restriction is shaping up to be a defining moment in EU chemicals policy. While its environmental and health goals align with the European Green Deal's "zero pollution" ambition, its success will hinge on whether regulators can strike a balance between precaution and legal coherence, scientific credibility, and economic feasibility. The coming year will be critical, as RAC and SEAC continue their review, and stakeholders prepare for potential implementation.
Our dedicated EU Regulatory team continue to monitor the PFAS restriction and related developments. For further information on how it might affect your company, please contact Koen Van Maldegem or Maud Grunchard.
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