Dear Members, please update from MedTech Europe on the proposal to nominate D4/D5/D6 Siloxanes under the UN Stockholm Convention on Persistent Organic Pollutants.
We are writing to share with you an important update with regard to D4/5/6.
We have recently understood that the European Commission has withdrawn its intention to nominate D4/5/6 as a POP under the Stockholm Convention on Persistent Organic Pollutants (links here and here).
This is a critical development for MedTech Europe members, as today, the EU has already regulated these substances under the D4/5/6 REACH Restriction. The EU Restriction has derogated many medical technology uses, including IVDs, MDs, and provided for 7-year transitional periods. Any potential international POPs classification (without derogations for our uses), would have then taken precedence over the REACH Restriction, thereby increasing the chance of losing/misaligning derogations.
As the European Commission has now withdrawn their intention to nominate D4/5/6 as POPs, there is no longer a risk of international-EU misalignment: the REACH Restriction, with its medical technology derogations, remains the reference legislation.
