Global regulation of per- and polyfluoroalkyl substances (“PFAS”) is increasingly targeting the restriction or phase-out of non-essential uses, permitting exemptions only for those deemed critical to society. The European Union is at the forefront, advancing a comprehensive, near-total ban on over 10,000 PFAS under the REACH regulation, with the aim of virtually eliminating these substances.
An article by Lincoln Tsang, partner and head of European Life Sciences, and Julie Kvedar, health care associate, examines recent regulatory developments across the European Union, United Kingdom, and United States, with a particular focus on compliance implications for the life sciences sector. Key events in 2026—including the progression of the EU REACH proposal towards a final opinion, ECHA’s public consultation on the SEAC draft opinion on PFAS restrictions, and the US EPA’s extension of its PFAS reporting deadline to 2027—underscore the urgency for companies to assess their product portfolios, supply chains, and regulatory exposure.
Regulatory pressure has intensified due to PFAS’ environmental persistence and bioaccumulation, as well as mounting evidence linking PFAS exposure to a range of health concerns. Policymakers are increasingly distinguishing between non-essential uses, where alternatives or reformulation may be feasible, and essential uses, where performance requirements, safety needs, or the absence of substitutes justify narrower, time-limited exemptions.
The commercial implications are significant. A European Commission study estimates that, if current levels of PFAS pollution persist through 2050, the cost to European society could reach €440 billion, with the cost of treating polluted water potentially exceeding €1 trillion.
The article highlights that for life sciences companies, early action may help mitigate risks associated with compressed development timelines, supply chain disruption, heightened regulatory enforcement, and reputational exposure as restrictions take effect.
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