In 2023, four EU Member States (Denmark, Germany, the Netherlands, and Sweden) and Norway, submitted an initial proposal to the European Chemicals Agency (ECHA) seeking a universal ban on per- and polyfluoroalkyl substances (PFAS), with phased restrictions. That proposal underwent a six-month public consultation period in the same year, during which ECHA received approximately 5,600 scientific and technical comments from third parties.

Updated Annex XV Report

Following the consultation, the four proposing Member States and Norway have now updated the Annex XV restriction report. The revised document, now labeled a Background Document, compiles the evidence collected during the six-month public consultation and will inform the opinions of ECHA’s scientific committees. These committees will evaluate the proposed restriction and provide recommendations to the European Commission, which will ultimately decide on the next steps.

The Annex XV report, in its original form, proposed two restriction options (ROs):

  • RO1 – A full ban on PFAS with an 18-month transition period.
  • RO2 – A ban with use-specific, mostly time-limited derogations of 5 to 12 years, also including an 18-month transition period.

Following the public consultation, the dossier submitters also considered alternative regulatory options (RO3), which could allow continued use of PFAS under strict conditions designed to minimize emissions across the full lifecycle. These alternatives may provide adequate risk control without imposing an outright ban. Some complementary measures have also been assessed in combination with RO2 to improve the effectiveness of the restriction.

Additional restriction options have been assessed for:

  • The Manufacture of PFASs
  • Transport
  • Electronics and semiconductors
  • Energy
  • Sealing applications
  • Machinery applications
  • Some technical textiles

The five authorities have also identified and conducted assessments for eight additional sectors that were not specifically addressed in the initial proposal. These sectors include:

  • Printing applications
  • Sealing applications
  • Machinery applications
  • Other medical applications, such as immediate packaging and pharmaceutical excipients
  • Military applications
  • Explosives
  • Technical textiles
  • Broader industrial uses, including solvents and catalysts

ECHA’s scientific committees, Risk Assessment (RAC) and Socio-Economic Analysis (SEAC), are continuing their evaluation of the updated proposal. Their opinions will be transmitted to the European Commission to inform its restriction decision. The Commission will then, on the basis of the evidence available to it, decide on the opportunity of a restriction and, as the case may be, submit a restriction proposal to the opinion of the Member States in comitology.ion and, as the case may be, submit a restriction proposal to the opinion of the Member States in comitology.

Impact on Companies

While the proposal is still under review, companies that manufacture, import, or use PFAS-containing products should begin evaluating potential operational impacts. The emergence of alternative regulatory options (especially RO3) may create new compliance requirements, including conditions to minimize emissions or reporting obligations. Engagement is strongly recommended to:

  • Understand potential compliance obligations under different restriction scenarios.
  • Assess operational and supply chain impacts.
  • Develop proactive risk mitigation strategies.

The EU PFAS restriction landscape is evolving. Companies should act now to understand and prepare for potential regulatory changes, including possible use-specific or conditional allowances under the emerging alternatives. At Squire Patton Boggs, we assist companies in navigating evolving EU chemical regulations, including PFAS restrictions. Our team can help you assess potential impacts, develop compliance strategies, and engage effectively with regulatory authorities to protect your business interests.