Final revision of background document for universal PFAS restriction is now completed. Authorities from five countries (Germany, the Netherlands, Norway, Denmark and Sweden) have taken into account the feedback of more than 5 600 comments from stakeholders. Relevant input has been implemented into the background document which has been shared with the European Chemicals Agency (ECHA) and published on their website.
In January 2023, an extensive Annex XV report initiating a restriction process for PFAS was submitted by the REACH-competent national authorities from Germany, the Netherlands, Norway, Denmark and Sweden, in the following referred to as Dossier Submitters (DS). It concerns more than 10 000 substances that are very persistent in the environment together with other concerning intrinsic properties. PFAS-based products are also widely used in society.
Since the end of the six-month consultation on the Annex XV report in September 2023, the initial report, called background document (BD) in this stage of the process, has been updated in phases by the DS to take into account the information from the consultation.
The DS completed the final version of the background document (BD) and shared it with the European Chemicals Agency (ECHA) on the 24th of June 2025. This concludes the work of the DS in this phase of the restriction process.
The DS have carefully assessed all of the over 5 600 consultation comments for relevant information including substantiated evidence on e.g. concerns for health and the environment, uses, volumes, emissions, alternatives and economic impact. Together with available scientific and technical publications, this information supplements the information basis for a restriction of PFAS with either use-specific time-limited derogations or with time-unlimited derogations and risk reduction measures of similar efficiencies, where assessed as appropriate.
The comments enabled to improve the assessment of the initially evaluated uses and the refinement of the restriction options, but also enabled an assessment of overarching topics. These include topics such as whether derogations are required for the second-hand market, recycling and spare parts. Additionally, eight sectors were introduced into the BD. These were either not covered or only partially included in other sectors in the original Annex XV report. These sectors are: printing applications, sealing applications, machinery applications, other medical applications (falling outside the scopes of active pharmaceutical ingredients and medical devices), explosives, military applications, technical textiles and broader industrial uses (e.g. solvents and catalysts used in industrial settings).
All the new information received during the consultation made the BD grow significantly, exemplified by the main report being >100 pages longer, and Annex E containing information on for example alternatives, environmental and economic impact being >800 pages longer, compared to the 2023 original Annex XV restriction report. This reflects the vast increase of knowledge on PFAS initiated by the restriction process.
The Scientific Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) of the European Chemicals Agency (ECHA) are currently preparing their opinions based on the BD and the comments received during the consultation. The Agency is to provide the European Commission with the RAC and SEAC opinion and the European Commission will ultimately decide on the restriction in consultation with the EU (European Union ) Member States. More information on the timeline and process will be published on ECHA's website.