Dear Members, please see the following update from MedTech Europe on the draft EU POPs Regulation regarding UV-328. It would appear that we will see some divergence in the requirements between the EU and UK, with the EU legislation applying to products placed on the NI Market.
Dear members,
We are writing to inform you that the revised draft delegated acts for the EU POPs implementation of the UV-328 Stockholm Convention listing, have been submitted to the European Parliament and Council for a 2-month scrutiny period on 5 May 2025.
The revised delegated acts are available here: Act and its Annex. We see some positive movements, despite the advanced stage of the decision-making process:
- The threshold has been improved compared to August, to now first set a limit of 0.01% w/w and gradually over 2 and then 4 years, go down to 0.001% and 0.0001% respectively (the 2024 draft proposed 0.0001% upon entry into force).
- The August acts stated that the medical technology exemptions are ‘until 26 February 2030’; whereas, they now state “5 years after entry into force of this Regulation” à this new wording provides additional flexibility, as we expect the acts to enter into force end of summer/beginning of September, which extends the transitional period by half a year, compared to the August version.
- Confirmation legacy articles can continue to be used, subject to the conditions in article 3.
We would also like to note that the EU POPs Regulation article 4(2) allows for a 6-month grace period from Member State enforcement of the EU decision, starting from the date of entry into force of the UV-328 act. Please review this article carefully, as it also contains conditions.
In terms of next steps, we expect the following:
- The acts have been sent to the Parliament and Council for scrutiny on 5 May. Scrutiny is expected to take a minimum of 2 months. This is a yes/no vote, no amendments are possible.
- The act states that it will then enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
- Considering this process, we would therefore expect the acts to enter into force by the end of this summer/early September, as previously communicated.
Please note that the Dechlorane Plus delegated act is not sent to scrutiny yet, but we expect this to come imminently as well, and will communicate to members as soon as we see it.
