The European Chemicals Agency (ECHA) ECHA has published an updated proposal to restrict per- and polyfluoroalkyl substances across the EU. The revision was prepared by authorities in five countries and incorporates responses from the public consultation. ECHA’s scientific committees will evaluate the updated background document and prepare independent opinions to inform the European Commission’s decision.
- The public consultation ran from 22 March to 25 September 2023 and received more than 5,600 scientific and technical submissions from industry, civil society and other stakeholders.
- ECHA’s Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) are evaluating the updated Annex XV background document and will prepare independent opinions.
THE BACKDROP: Authorities from Denmark, Germany, the Netherlands, Norway and Sweden submitted the restriction proposal to ECHA on 13 January 2023. The dossier aimed to reduce PFAS emissions and address risks to people and the environment. The five authorities acted as the Dossier Submitter and updated the Annex XV background document following consultation feedback.
- The dossier aims to reduce PFAS emissions and address risks to people and the environment across products and industrial processes through restriction measures.
- The updated background document incorporates revisions following evaluation of consultation responses and additional evidence provided to the dossier submitters for review by committees.
CONSULTATION FEEDBACK: Stakeholders submitted more than 5,600 comments during the six-month consultation in 2023. Contributions comprised scientific and technical comments and information on socio-economic impacts. The dossier submitters reviewed the submissions and used the evidence to update the Annex XV background document now under RAC and SEAC assessment.
- Respondents submitted over 5,600 scientific and technical comments during the 2023 consultation period, providing technical evidence and positions to inform the dossier submitters’ review.
- Contributions came from companies, civil society, research institutions and other stakeholders across numerous sectors and supply chains, offering technical and contextual information.
EXPANDED SECTORS: The Dossier Submitters identified eight sectors that were not specifically named in the initial submission. These are now assessed within the background document to broaden the scope of the restriction proposal and to provide sector-specific evaluations for committee review.
- Newly assessed sectors listed include printing applications and sealing applications, which the background document now evaluates for relevant uses and potential releases.
- Also included are machinery applications and other medical applications, such as immediate packaging and excipients for pharmaceuticals, explicitly included in sectoral assessments.
- The list further includes military applications, explosives, technical textiles and broader industrial uses such as solvents and catalysts, each evaluated for exposure and use patterns.
ALTERNATIVE OPTIONS: The Dossier Submitters examined a range of restriction options, including a full ban and a ban with use-specific, time-limited derogations. They also considered alternative regulatory options allowing continued manufacture, placing on the market or use of PFAS where the risks can be controlled. These alternatives were assessed for effectiveness, practicability, monitorability and socio-economic proportionality compared with other options.
- RO1 is described as a full ban with a transition period envisaged in the proposal; the dossier assesses its implementability and emission reduction potential.
- RO2 combines a ban with use-specific derogations that are mostly time-limited and include defined transition periods for particular uses.
- RO3 comprises alternative regulatory options permitting continued manufacture, placing on the market or use of PFAS under strict conditions, assessed for monitorability and proportionality.
SOCIO-ECONOMIC IMPACTS: The dossier submitters estimated PFAS tonnages for the EEA, reporting 186,000 to 340,000 tonnes introduced to the market in 2020. Over 2025–2055 the expected mean PFAS tonnage in the EEA is 27 million tonnes, leading to estimated emissions of about 4.7 million tonnes if no action is taken. The report compares emission reductions and proportionality across RO1, RO2 and RO3.
- The report estimates 186,000 to 340,000 tonnes of PFAS were placed on the EEA market in 2020 across numerous product categories and industrial applications.
- Without action, an expected mean of 27 million tonnes could be used in the EEA between 2025 and 2055, potentially leading to significant environmental releases.
- Over that period, emissions are estimated at about 4.7 million tonnes under the baseline scenario if no restrictions are implemented.
NEXT STEPS: ECHA’s Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will continue to evaluate the updated Annex XV background document and prepare independent opinions. Those opinions will be submitted to the European Commission, which will consult Member States and decide whether to adopt a restriction under REACH.
