For review: EU Restrictions Roadmap – Revised June 2025

Please see the below MedTech Europe Update on ECHA’s proposed Restriction roadmap. Note that this will impact products placed on the EU and Northern Ireland markets. If you impacted by the proposals to restrict use of these chemicals, please let me know via regulatory@bivda.org.uk

As previously discussed evidence of the impact and lack of available alternatives has been key in obtaining specific use exemptions or derogations, or as evidence of the need for extended transition timelines, however members need to be aware that if proposed then its highly likely that restrictions will be put in place, and strong evidence to support continued use is required, however members are strongly recommended to seek to substitute the use of these chemicals for existing products, or seek to use alternatives in future products.

We are writing to share with you the updated European Commission ‘EU Restrictions Roadmap’, which has been published today, based on updates made to it in June 2025 (link).

This Restriction Roadmap is one of the tools that the EU uses to provide predictability on the substances that will be assessed in the near future, for potential Restriction. In this update, there are two key points that are of relevance for MedTech Europe and that we had been waiting for:

1. PVC and its additives [NEW timeline]:
   1. The previous versions indicated that the European Commission will announce in Q3 2025 whether it will mandate ECHA to begin a Restriction of PVC and its additives. The new version from June 2025 now instead indicates ‘TBD’.
   2. This is very important news, as MedTech Europe had been preparing for a potential Restriction mandate (this was the suggestion of ECHA in its 2023 report), and we had gathered  over 30 case studies illustrating the challenges with substituting PVC from medical technologies.
   3. As there is now no specified timeline for a potential Restriction and given the high importance of PVC, we will continue to monitor closely any future timeline updates or intentions of the Commission to regulate/restrict PVC and its additives.
2. Flame retardants (i.e. Aromatic Brominated Flame Retardants) [CONFIRMED timeline]:
   1. The previous and new versions both confirm that in Q3 2025, the Commission will announce whether they will mandate ECHA to begin a Restriction of Aromatic Brominated Flame Retardants (this will also include e.g. TBBP-A, TBPH, amongst others).
   2. MedTech Europe engaged in the second ECHA call for evidence last year, explaining the uses and consequences of a potential Restriction.
   3. Please note that, based on the EU Flame Retardant Strategy and the ECHA 2024 recommendation to have a Restriction on this group of substances, as Secretariat, we consider it likely the Commission will indeed grant ECHA a Restriction mandate.
   4. We will monitor closely to see if such a Restriction mandate is launched by the Commission in Q3 or later, and will inform members of the process and opportunities to engage on this in the coming years.

Please note that these are the main changes in the Restriction Roadmap, based on the dossiers we have a mandate to engage on. We nevertheless invite members to review the other changes highlighted in yellow in the Restrictions Roadmap and let us know if you see an impact from the other changes/new substances listed.