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Revision of Regulation (EU) 2017/852 on mercury

In “A European Green Deal”

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In the EU Zero Pollution Action Plan, presented on 12 May 2021 under the European Green Deal, the European Commission announced that it would revise the EU Mercury Regulation to phase out the use of dental amalgam and prohibit the manufacture and trade of a number of mercury-added products, including certain lamps. The EU Mercury Regulation is one of the key EU instruments transposing the Minamata Convention, a global treaty adopted in 2013 to protect human health and the environment from the adverse effects of mercury.

The EU Mercury Regulation has restricted the use of mercury in most mercury-added products, and already forbids, as from 1 July 2018, the use of dental amalgam for treatment of teeth of children under 15 years and for pregnant or breastfeeding women.

The Commission tabled the proposal for a revision of the Mercury Regulation on 14 July 2023. The proposal addresses the last intentional remaining uses of mercury in products in the EU, with a view to establishing a mercury-free Europe. The proposed revision would extend the prohibition to use dental amalgam to include all members of the population as from 1 January 2025 (total phase-out), except when deemed strictly necessary by the dental practitioner for addressing specific medical needs of the patient. The revision would also prohibit the manufacturing in the EU and export of dental amalgam as from 1 January 2025. Six additional mercury containing lamps would be made subject to a manufacturing, import and export prohibition as from 1 January 2026 and 1 January 2028, depending on the type of lamps.

In Parliament, the Committee on the Environment, Public Health and Food Safety (ENVI), responsible for the file, appointed Marlene Mortler (EPP, Germany) as rapporteur.

The ENVI committee considered its rapporteur's draft report on 20 November 2023. In her text, the rapporteur suggests postponing the date of the ban of the use of amalgam until 1 January 2027, with a view to allowing all Member States and national health insurance schemes to adjust their frameworks adequately. She also proposes to push the date of the ban on the manufacture and export of amalgam to 1 January 2027, in order to ensure that the demand of dental amalgam during the transition period can be met. The European Commission would be required to assess the socio-economic impact of the proposed ban on patients generally, patients dependent on amalgam-fillings and the impact on dentists of a shift to mercury-free fillings, and the developments in healthcare reimbursement schemes. By 30 June 2025, the Commission should submit a report to Parliament and Council on the outcomes of such assessment, and propose measures where appropriate.

The ENVI committee adopted its legislative report on 11 January 2024. The report supports the prohibition on dental amalgam use from 1 January 2025, except when deemed strictly necessary by the dental practitioner based on duly justified specific medical needs of the patient, and requires the Commission to assess, by mid-2026, the feasibility of withdrawing the exemptions by 2030, while looking into the impact on the health of patients generally and patients dependent on amalgam fillings. By the end of 2025, the Commission should report to Parliament and Council on the reduction of mercury emissions from crematoria, based on Member States' reporting on their planned and implemented reduction measures. Where appropriate, the Commission should draft guidelines on the abatement technologies to control and reduce such emissions. By the end of 2026, it should report on the need to phase out remaining mercury uses, such as in lighthouses and porosimetry, and if necessary, propose measures.

The report, put to the vote at the January I plenary session, was adopted with one amendment introducing a new recital calling for appropriate reimbursement for mercury-free fillings and professional training for dentists to adjust to new techniques, where needed. This set Parliament's position for negotiations with the Council.

The Council adopted its negotiating mandate on 30 January 2024. Trilogue negotiations concluded on 8 February 2024 with a provisional agreement. 

The co-legislators agreed to phase out the use of dental amalgam in the EU from 1 January 2025 except if deemed strictly necessary by the dental practitioner based on the duly justified specific medical needs of the patient. However, they introduce an 18-month derogation for those member states where low-income individuals would be socio-economically disproportionally affected  by a phase-out date of 1 January 2025. Within one month of the entry into force of the revised regulation, Member States must justify their use of the derogation and notify the Commission of the measures they intend to implement to achieve the phase-out by 30 June 2026. Under the deal, the export of dental amalgam will also be prohibited from 1 January 2025, while the manufacturing and import into the EU will be banned from 1 July 2026 (except to cover specific medical needs). By the end of 2029, the Commission will review the implementation and impact of guidelines in member states on how to abate emissions from crematoria. The review should also look into the necessity to maintain the exemptions for the use of dental amalgam, and the necessity to maintain the derogation for the manufacture and imports of dental amalgam. It should also include an assessment of the need to phase out remaining mercury uses and to expand the list of mercury waste sources.

The agreed text was approved by the Council's Permanent Representatives Committee on 21 February 2024, and by the ENVI Committee on 11 March 2024 (with 74 votes in favour, 1 vote against and 3 abstentions). Following formal adoption by the co-legislators, the final act was signed on 13 June 2024. On 10 July 2024, the text was published in the EU Official Journal as Regulation (EU) 2024/1849, and entered into force 20 days later, on 30 July.

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Further reading:

Author: Vivienne Halleux, Members' Research Service, legislative-train@europarl.europa.eu

As of 15/12/2024.