The EU have proposed to add Lead to the EU REACH Annex XIV Substances subject to authorization.
In 2022, ECHA launched a public consultation on whether Lead should be included in the REACH Authorisation list. MedTech Europe submitted its feedback advising against such a listing, mainly because most of the uses are already covered under RoHS (exemptions) and the Commission should avoid double regulation. The following year, ECHA published a recommendation report advising the Commission to pursue an Annex XIV inclusion.
We are now awaiting the Commission proposal in the Spring this year to see what the proposal will be.
In October 2023, a Member of European Parliament tabled a written question to the Commission asking whether the Commission plans to ban the use of lead in the EU, as it did for mercury.
On 17 January 2024, a response was published on behalf of Commissioner Breton (at the link here) stating that the Commission does not intend to ban the use of lead. Although ECHA have recommended the Commission to pursue Annex XIV inclusion, the Commission is not obliged to follow this recommendation and does not intend to include lead in the authorisation list.
Please note that whilst this response can be perceived as aligned with the MedTech Europe’s position, we must wait for the Commission proposal, formal adoption by the Council and Parliament, and finally publication in the EU Official Journal, to be certain of this outcome.
This information is kindly provided by MedTech Europe.