The EU has prepared the phasing out of dental amalgams.
New timelines have been agreed on 8 February 2024 (formal votes are following in Spring in Parliament and in Council).
2 derogations are nevertheless planned.
Hereafter is the situation.
In 2025 starts the general ban
January 1, 2025 officially marks the end of mercury amalgam use for all patients in Europe. The date of 2027, advocated by many and in particular by the Rapporteur at the beginning of the parliamentary debate, failed to win a majority in Parliament and the Member States.
2 derogations are nevertheless planned.
First derogation : at the discretion of the dental practitioner given the patient’s needs
Until December 31, 2029, under exactly the same conditions as today, the dental practitioner may still use amalgams if the patient’s situation justifies it: if “From 1 January 2025, dental amalgam shall 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.” (new Article 10(2a)).
As we can see from this wording, the legislator leaves it entirely to the discretion of the professional.
With which mercury components? The one manufactured or imported for these cases only (declared and reported as such); apart from this situation, manufacture in Europe and import of mercury will cease from July 1, 2026.
This derogation is not permanent. On December 31, 2029, the Commission will review the situation and verify the need to maintain this derogation, taking into account the needs of patients.
Second derogation : to be negotiated by Member States under specific justifications
The legislator has provided EU countries with a transition period.
Until June 30, 2026, the use of mercury amalgam will be permitted in Member States where it is economically needed :
“Fully respecting Member States’ competence for the organisation and delivery of health services and medical care (…), where in a Member State dental amalgam is the only publicly reimbursed material at a rate of at least 90 % under national law for patients who are not eligible for other reimbursed materials of dental filling and persons with low income are socio-economically disproportionately affected by a phase-out date of 1 January 2025, dental amalgam may be used for dental treatment until 30 June 2026″.
This self-declaration is allowed provided the concerned Member State shows its next steps.
“Member States shall make publicly available reasoned explanations for making use of this derogation, including the appropriate measures to be implemented by 30 June 2026, and notify them to the Commission” (new Article 10(2bis) in fine).
2030 is not the maximum deadline anymore in the EU
In its Impact Assessment joined to the legislative proposal, the EU Commission reported on the Member States which organized different domestic deadlines by which the phasing out took place in their own national health system.
2030 was one of them (see the 7th column “phase-out plan” in the tables below).
Outside the EU, 2030 looks like the consensual and definitive deadline for ending the use of dental amalgams in the world.
Recall of the former scenarios
In its first mapping of the situation released in 2020, a report drafted for the EU Commission estimates how the on-going phasing-down of dental amalgams in Europe can lead to a phasing-out :
-through scenarios where the timeline is accelerated by the EU legislator (e.g. by 2025 proposed today by the EU Commission, or by 2027, see the picture below); or,
-through a scenario taking stock of the engaged decrease of mercury until its end of use by 2030.
Source :
1- SWD(2023) 396 final COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT REPORT -Accompanying the document Proposal for a REGULATION 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. The first pictures are extracted from this assessment.
2-Assessment of the feasibility of phasing-out dental amalgam – Final report (under Framework Contract No. ENV.C.4/FRA/2015/0042 – Service request 15). The second picture is extracted from this assessment.
3-Text of compromise agreed by the EU legislator on 8 February 2024.