We are writing to inform you that ECHA has just published a press release outlining further insights into the timelines for the adoption of the ECHA RAC & SEAC Opinion on the PFAS Restriction proposal (link).
The press release states that the ECHA RAC & SEAC opinion will most likely be adopted towards the end of 2026. This is because there are still some horizontal sections that need to be discussed, together with the 60-day SEAC consultation (H1 2026), and to have some time left to process the SEAC consultation comments and finalize the opinion.
What is new for us is the following: “However, including a further 8 sectors into the Committees’ evaluations now would require significant time beyond 2026 to finalise the opinion with these sectors. Therefore, in the ongoing procedure, the Committees will not carry out a sector specific evaluation of these further eight sectors. However, the evaluation of horizontal issues will cover, amongst others, the hazard assessment and risk management measures of general applicability that are able to monitor and limit emissions of PFAS to the environment (e.g. reporting requirements, PFAS management plan).”
Please note that amongst these 8 sectors is the new sector ‘other healthcare applications’, which was meant to cover pharmaceuticals & f-gases in pharmaceutical applications. This sector was not meant to discuss our uses, as our uses have already been assessed in June 2025 and some remaining overlapping uses will be discussed now in September and December this year.
We read this press release as an understanding from regulators that the industry needed clarity on the timelines and next steps on the dossier. In view of this, we are pleased that our sector was discussed already and that we had a chance to raise all our points and help shape the draft opinion, e.g. sectoral legislation/specificities, as well as our sector’s proactive work, such as the IHI PFAS project.
We would also like to inform members that yesterday, MedTech Europe received approval from ECHA to participate in all sector discussions in September, namely: energy, lubricants, PFAS manufacturing, and electronics and semiconductors. As previously discussed with members, we will continue to raise key issues, from our position paper, especially in electronics & semiconductors, where we expect discussions on our electronic medical devices.
