Dear members, please see below update on the progress of the proposed PFAS restriction under EU REACH which will also impact Northern Ireland.
We are writing to inform you that today, ECHA published the updated PFAS Restriction proposal (link).
This is an important milestone, as this updated proposal, reveals all changes that the Dossier Submitters (Denmark, Germany, Netherlands, Norway, and Sweden) made, based on the input that was submitted to the 2023 public consultation.
In terms of content, there are changes made to the medical applications in the report, however, we have kept members informed of these changes/developments over time. What we would like to emphasize is that a distinction is to be made between (1) this updated proposal (which was the foundation for the RAC/SEAC discussion on our sector in June) and (2) the RAC/SEAC draft opinions in June which made further changes/assessments to the medical technology part of the proposal (e.g. volumes, emissions, exemptions, etc.).
As previously mentioned to members:
- The draft RAC/SEAC opinion on medical devices is still confidential and will be published as part of the SEAC 60-day consultation.
- MedTech Europe has contributed to the shaping of the RAC/SEAC opinion as part of the June session on the medical devices sector and debriefed members in the June Chemicals WG.
- Further medical uses will continue to be discussed under other overlapping sectors/applications e.g. electronic medical devices will be handled in September as part of the electronics & semiconductor sector.
- Based on the feedback from the 2023 consultation, 8 new sectors have been added, which is also why the adoption of the Restriction will be slightly postponed, in order for ECHA to be able to evaluate these as well. The SEAC 60-day consultation is therefore no longer expected for this year, but rather later in 2026.
Therefore, whilst the contents of the revised Restriction proposal have been known to us as we have engaged on it in June, it is now finally publicly available to all stakeholders and importantly, the latest assessment/data/exemptions on our sector is found in the RAC/SEAC draft opinion which is not yet publicly available.
