ECHA: 'PFAS' Restrictions updated
Recommendation

20 October 2026
Copenhagen, Denmark
An ECA Course prior to the 29th APIC/CEFIC Global GMP & Regulatory API Conference
The ECHA (European Chemicals Agency), together with five other European authorities (Denmark, Germany, the Netherlands, Norway and Sweden), has updated its approach to restricting 'PFAS' (per- and polyfluoroalkyl substances) and published it on its website in August 2025.
The report 'Background Document to the Opinion on the Annex XV dossier proposing restrictions on per- and polyfluoroalkyl substances (PFASs)', first published in 2023, has been extensively revised and is now valid in version 14. According to the change history, chapters 1 and 2 and the introduction and conclusion in particular were subject to changes and adjustments.
Chapter 1
Updates can be found in sections 1.1.5.4 Product use emissions and 1.1.5.6. Conclusion on emissions, as well as in sections 1.3. Baseline and 1.3.2. Manufacture and use - Market developments.
Chapter 2
In Chapter 2, the changes and adjustments relate to sections 2.4.1.1. Economic impacts on producers and customers and other impacts (e.g. employment losses), 2.4.2. Human health impacts, 2.4.3. Environmental impacts and section 2.4.4. Proportionality to the risk.
Further information on ECHA's approach to restricting PFAS and the full report 'Background Document to the Opinion on the Annex XV dossier proposing restrictions on per- and polyfluoroalkyl substances (PFASs)' can be found in the News section of the ECHA website.
Related GMP News
14.10.2026EMA Reports inconsistent Progress in International API Inspection Cooperation
23.09.2026FDA Warning Letter: serious GMP Deficiencies at a Chinese API Manufacturer
16.09.2026PFAS restriction: Commission highlights Importance of critical Medical Applications
16.09.2026IPEC: Updated Qualification-Guide published
09.09.2026IPEC: New Stability Guide for Excipients Published


