Brussels, 30 May 2024: With the adoption by the Council, the phase-out of dental amalgam by January 2025 has been finalized. The European Parliament had already given its approval on April 10 with a majority of 98%. After being signed by the Presidents of the European Parliament and the Council, the legal act will soon be published in the Official Journal of the European Union and enter into force.
With an average of 0.6 grams per filling and a total consumption of 40 tons of mercury per year, dental amalgam is the largest remaining use of mercury in the EU and contributes significantly to environmental pollution. The use of amalgam is not just a local problem, but an international threat as mercury pollution crosses borders via air and waterways.
Environmental conditions are alarming: 40% of surface waters in the EU are contaminated with mercury, posing a threat to birds and marine mammals that feed on contaminated fish or shellfish, and also endangering human consumption of fish.
Florian Schulze, Managing Director of the European Network for Environmental Medicine, is relieved: “Dental amalgam consists of 50% highly toxic mercury and endangers patients as well as dentists and dental professionals. Young women in particular should not inhale mercury vapors and put their baby or future pregnancy at risk. Alternatives are proven, cost-effective, safe, just as durable and, above all, more tooth-friendly.”
The regulation provides for the following measures:
- From 1 January 2025, dental amalgam should not be used for dental treatment in the Union, except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient.
- In Member States where dental amalgam is the only material that is at least 90% publicly reimbursed under national law and where such reimbursement is not yet possible for mercury-free alternatives as of 1 January 2025, dental amalgam may be used for dental treatment until 30 June 2026 in order to limit the socio-economic impact of the phasing out of dental amalgam, in particular for low-income patients. Member States should provide reasoned justifications for the use of the derogation.
- From 1 January 2025, the export of dental amalgam should be prohibited.
- From 1 July 2026, the import and manufacturing of dental amalgam should be prohibited. By way of derogation, the import and manufacturing of dental amalgam should be allowed for specific medical needs.
- By 31 May of a given calendar year, importers and manufacturers of dental amalgam should report to their competent authority for the preceding calendar year the amount of dental amalgam they imported or manufactured.
- By 31 December 2029, the Commission should report to the European Parliament and to the Council on the need to maintain the exemption from the prohibition on the use of dental amalgam.
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