PFAS restriction procedure: ECHA publishes background document
The revision of the background document on the planned restriction of PFAS has been completed. The submitting authorities have evaluated over 5600 comments and integrated relevant information. The document has now been published by the European Chemicals Agency - an important milestone in the European PFAS restriction process.
In January 2023, the national authorities responsible for the European chemicals regulation REACH of Denmark, Germany, the Netherlands, Norway and Sweden, hereinafter referred to as the "dossier submitters", submitted a comprehensive Annex XV report on the initiation of a restriction procedure for per- and polyfluorinated alkyl substances (PFAS). It concerns more than 10,000 substances that are highly persistent in the environment and have other inherent properties of concern. PFAS-containing products are widely used in society. Since the end of the six-month consultation on the Annex XV report in September 2023, it has been progressively updated by the dossier submitters to take into account the information from the consultation. At this stage of the process, the report is referred to as a background document.
Background document submitted to ECHA
The dossier submitters submitted the final version of the background document to ECHA on June 24, 2025. This completes the work of the dossier submitters in this phase of the restriction procedure. The dossier submitters have carefully reviewed all of the more than 5600 consultation comments for relevant information, including, for example, substantiated evidence on health and environmental concerns, uses, quantities, emissions, alternatives and economic impacts. Together with available scientific and technical publications, this information complements the information base for restricting PFAS with either temporary or permanent use-specific exemptions, where assessed as appropriate. Indefinite exemptions are combined with risk mitigation measures that can achieve comparable effectiveness in terms of emission reduction.
Exemptions for certain PFAS applications
The comments made it possible to improve the assessment of the areas of use originally considered and to refine the restriction options, but also to assess overarching issues. These include issues such as whether exemptions are needed for the second-hand market, recycling or spare parts. In addition, eight sectors were included in the background document that were either not addressed or only partially addressed within other sectors in the original Annex XV report. These are the following uses/sectors: printing applications, sealing applications, machinery applications, other medical applications (outside the scope of active pharmaceutical ingredients and medical devices), explosives, military applications, technical textiles and wider industrial uses (e.g. solvents and catalysts used in industrial environments).
EU Commission decides on restriction
The new information received during the consultation has led to a significant expansion of the background document. This is reflected, for example, in the fact that the main report is more than 100 pages longer and Annex E, which contains information on alternatives, environmental and economic impacts, is more than 800 pages longer than the original 2023 Annex XV report. This reflects the enormous increase in knowledge about PFAS that has been triggered by the restriction process. ECHA's Scientific Committees for Risk Assessment (RAC) and for Socio-economic Analysis (SEAC) are currently preparing their opinions based on the background document and the comments received during the consultation. ECHA will forward the opinions of RAC and SEAC to the European Commission, which will take a final decision on the restriction after consulting the EU Member States. Further information on the timetable and the procedure will be published on ECHA's website.