Mercury: dental amalgam and other mercury-added products subject to manufacturing, import and export restrictions

PURPOSE: to phase out the use of dental amalgams and ban the manufacture and export of dental amalgams and certain mercury-containing lamps.

LEGISLATIVE ACT: Regulation (EU) 2024/1849 of the European Parliament and of the Council amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions.

CONTENT: the regulation aims to completely ban the use of dental amalgams and to prohibit manufacturing, import and export of other mercury-added products.

The new rules provide that 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.

Dental amalgam may be used for dental treatment until 30 June 2026 in order to limit the socio-economic impact of the phase-out of dental amalgam, in particular on low-income patients. Member States in which dental amalgam is the only publicly reimbursed material at a rate of at least 90 % under national law, and in which such reimbursement is not yet possible for mercury-free alternatives as of 1 January 2025. Member States will provide reasoned explanations for making use of the derogation.

Exporting dental amalgam will be prohibited from 1 January 2025; the ban on manufacturing and import in the EU will apply from 1 July 2026.

Six additional mercury-containing lamps will also be made subject to a manufacturing, import and export ban as from 31 December 2025 and 31 December 2026.

The Commission will review the exemptions on the use of dental amalgam by 31 December 2029, taking into account the availability of mercury-free alternatives.

By the same date, the Commission will also: (i) review measures taken by member states on mercury emissions from crematoria and the impact of the Commission’s guidance on relevant abatement technologies; (ii) developments under the Minamata Convention regarding the phasing out of the illegal use of mercury in cosmetic products and (iii) the need to expand the list of sources of mercury waste.

ENTRY INTO FORCE: 30.7.2024.