REACH Annex XV Restriction (Universal PFAS)

The universal PFAS restriction is a proposed amendment to REACH Annex XVII that would restrict the manufacture, placing on the market, and use of all per- and polyfluoroalkyl substances in the EU/EEA. Submitted in January 2023 by five national authorities (Denmark, Germany, Netherlands, Norway, Sweden), it is the broadest chemical restriction ever proposed under REACH. ECHA’s RAC adopted its final opinion in March 2026 confirming PFAS warrant a group-wide restriction. SEAC agreed its draft opinion in March 2026, with a 60-day public consultation closing May 2026. SEAC’s final opinion is expected by end of 2026, after which the European Commission will draft the restriction regulation.

REACH Annex XV Restriction Report (January 2023, updated August 2025); ECHA RAC Final Opinion (March 2, 2026); ECHA SEAC Draft Opinion (March 11, 2026); REACH Regulation (EC) No 1907/2006, Article 68–73.

This restriction will fundamentally reshape PFAS use in Europe. RAC confirmed that PFAS as a group pose unacceptable risks to human health and the environment and estimated a ban could reduce emissions by ~96% over 30 years. SEAC is evaluating proportionality and derogations. The August 2025 updated proposal includes derogations for 231 identified sectors, with a third regulatory option (RO3) allowing continued use under strict emission controls for some applications. Companies selling in the EU must actively participate in the SEAC consultation (closing May 2026) to influence final derogation scope. A Commission decision is expected in 2027.

A medical device company that uses PFAS in implantable catheter coatings should submit detailed socio-economic evidence to the SEAC consultation demonstrating why PFAS use is essential for patient safety, what alternatives have been evaluated, and what transition timeline is realistic. This evidence will directly influence whether the company’s application receives a derogation in the final restriction.