EU finalises text of proposed dental amalgam phase-out ahead of vote

  Posted by: Dental Design      26th February 2024

The Council of the European Union, following the culmination of negotiations with the Commission and the Parliament, has published the provisional overall compromise text for the proposed phase-out of dental amalgam from 1st January 2025.

The text, which will need to be voted on by the European Parliament before entering into law, is largely unchanged from the version last put forward by the Council. Notable features include:

• A derogation for continued use of amalgam until 30th June 2026 in Member States “where treatment with dental amalgam is the only publicly reimbursed material at a rate of at least 90% under national law, while this is not yet possible for mercury-free alternatives as of 1 January 2025”
• Provision for continued manufacture and import of dental amalgam in order to support the above usage, until 30th June 2026. From 1st July 2026 “manufacturing and import should still be possible only to cover specific medical need”. 
• In order to assess the continuing need for use of dental amalgam in relation to specific medical needs, importers and manufacturers should inform the competent authorities annually of the quantities manufactured or imported for those purposes

By 31 December 2029 the Commission should assess if there is still a necessity to maintain the derogation for the manufacture and import of dental amalgam used for patients with specific medical needs, taking into account the availability of mercury-free alternatives for the relevant patient groups.