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DRAFT REPORT (COM(2023)0395 – C90309/2023 – 2023/0272(COD))

On the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury as regards dental amalgam and other mercury-added products subject to manufacturing, import and export restrictions

ENVI-PR-753554

Committee on the Environment, Public Health and Food Safety · Rapporteur: Marlene Mortler

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This is the rapporteur's draft report on the Commission proposal to amend Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products. The draft proposes to move the ban on the use of dental amalgam for dental treatment from 1 January 2025 to 1 January 2027, with an exemption when strictly necessary based on the patient's specific medical needs. It also proposes to move the ban on the manufacture and export of dental amalgam from 1 January 2025 to 1 January 2027. It adds new recitals on a transitional period for training dentists and adjusting national reimbursement systems, on ensuring reimbursement for mercury-free alternatives, and on assessing the impact of the manufacturing prohibition on patients dependent on amalgam fillings. It adds a new Article 19(3a) requiring the Commission to report by 30 June 2025 on the socio-economic impact of a shift to mercury-free fillings and on healthcare reimbursement schemes, and to propose measures where appropriate.

Committee position. The rapporteur proposes to amend the Commission proposal by moving the bans on dental amalgam use and on its manufacture and export to 1 January 2027, adding recitals on transitional training and reimbursement, and requiring a Commission report by 30 June 2025 on socio-economic impact.

Key points

  1. The draft report adopts Parliament's position at first reading on the Commission proposal amending Regulation (EU) 2017/852 on mercury.
  2. It calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal.
  3. A new recital 4a states that a short transitional period for the phase-out of dental amalgam is appropriate to allow professional training of dentists and adjustment of national reimbursement systems.
  4. A new recital 4b states that Member States should endeavour to ensure appropriate reimbursement is available for mercury-free alternatives to limit socio-economic impact on patients and dentists.
  5. A new recital 5a states that the Commission should assess the impact of the manufacturing prohibition on patients dependent on amalgam fillings in a dedicated report to monitor price developments and prevent pressure on economically weak citizens.
  6. Amendment 4 changes Article 10(2a) so that from 1 January 2027 dental amalgam shall not be used for dental treatment of any member of the population, except when deemed strictly necessary by the dental practitioner based on the patient's specific medical needs.
  7. Amendment 5 changes Article 10(7) so that from 1 January 2027 the manufacture and export of dental amalgam shall be prohibited.
  8. Amendment 6 adds Article 19(3a) requiring the Commission to report by 30 June 2025 on the socio-economic impact on patients generally, patients dependent on amalgam fillings and dentists of a shift to mercury-free fillings, and on developments in healthcare reimbursement schemes.
  9. The same new Article 19(3a) states that the Commission shall, where appropriate, propose measures together with its report.
  10. The explanatory statement says the rapporteur supports the Commission's approach on the exemption in extraordinary circumstances and suggests pushing the ban on use of amalgam back to 1 January 2027 to allow Member States and national health insurance schemes to adjust.
  11. The explanatory statement says the rapporteur proposes to change the date of the ban on manufacture and export of amalgam to 1 January 2027 to ensure demand during the transition period can be met.
  12. The explanatory statement says the supply of dental amalgam for specific needs should be guaranteed even after the ban on manufacture takes effect, to avoid price increases for patients with specific medical needs.

Who is affected

  • Dentists and patients in the EU, who would face a later ban on dental amalgam use from 1 January 2027, with an exemption for specific medical needs.
  • Manufacturers and exporters of dental amalgam, who would face a ban on manufacture and export from 1 January 2027.
  • Member States, which should endeavour to ensure appropriate reimbursement for mercury-free alternatives and adjust national reimbursement systems.
  • Patients dependent on amalgam fillings and economically weak citizens, whose costs the Commission should monitor and assess.
  • The Commission, which would have to report by 30 June 2025 on the socio-economic impact and reimbursement schemes, and propose measures where appropriate.

Figures and deadlines

  • 1 January 2027: date from which dental amalgam shall not be used for dental treatment, except when strictly necessary.
  • 1 January 2027: date from which the manufacture and export of dental amalgam shall be prohibited.
  • 30 June 2025: deadline for the Commission to report on the socio-economic impact and reimbursement schemes.

Legal basis: Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union.