Regulation 2024/1849 - Amendment of Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions

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1.

Current status

This regulation entered into force on July 30, 2024.

2.

Key information

official title

Regulation (EU) 2024/1849 of the European Parliament and of the Council of 13 June 2024 amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions
 
Legal instrument Regulation
Number legal act Regulation 2024/1849
Original proposal COM(2023)395 EN
CELEX number i 32024R1849

3.

Key dates

Document 13-06-2024; Date of signature
Signature 13-06-2024
Effect 30-07-2024; Entry into force Date pub. +20 See Art 2
End of validity 31-12-9999

4.

Legislative text

 

Official Journal

of the European Union

EN

L series

 

 

2024/1849

10.7.2024

REGULATION (EU) 2024/1849 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 13 June 2024

amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

 

(1)

In accordance with Article 19(1) and (2) of Regulation (EU) 2017/852 of the European Parliament and of the Council (3), the Commission was to assess and report on the need for the Union to regulate emissions of mercury and mercury compounds from crematoria, the feasibility of phasing out the use of dental amalgam in the Union in the long term, and preferably by 2030, and the environmental benefits and the feasibility of banning the manufacturing and export of other mercury-added products which are prohibited from being placed on the Union market and imported into the Union.

 

(2)

Mercury is a chemical of global concern for the environment owing to its long-range atmospheric transport, its persistence following its anthropogenic introduction into the environment and its ability to bioaccumulate in ecosystems. Mercury also has significant negative effects on human health and is passed from mothers to children via the placenta or through breastfeeding. Mercury pollution of the environment can result from anthropogenic activities, including insufficient management of mercury waste, cremation or improper implementation of mandatory separators in dental practices.

 

(3)

The Commission, following the conclusion reached in its report of 17 August 2020 on the reviews required under Article 19(1) of Regulation (EU) 2017/852 on the use of mercury in dental amalgam and products, presented a legislative proposal, in accordance with Article 19(3) of that Regulation, on the phasing out of the use of dental amalgam and the prohibition of the manufacturing and export of dental amalgam and certain mercury-containing lamps.

 

(4)

The use of mercury-added products, including the use of dental amalgam and of mercury-containing lamps, represents the largest remaining intentional use of mercury in the Union. However, mercury-free alternatives have become economically and technically feasible and are readily available.

 

(5)

Considering that the Union and its Member States have ratified the Minamata Convention on Mercury (4) of 2013 (‘the Convention’) and given that measures should be taken by Parties to the Convention to encourage dental caries prevention and health promotion, thereby minimising the need for dental restoration as an additional measure to support the phase-out of the use of dental amalgam, and considering the availability and affordability of, and the current transition to, mercury-free alternatives in many Member States, it is appropriate to prohibit the use of dental amalgam for dental treatment in the Union, while maintaining the possibility of using dental amalgam for patients with specific medical needs when deemed strictly necessary by the dental practitioner.

 

(6)

While fully respecting Member States’ competence for the organisation and delivery of health services and medical care, in order to limit the socioeconomic impact of the phase-out of dental amalgam, in particular...


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This text has been adopted from EUR-Lex.

5.

Original proposal

 

6.

Sources and disclaimer

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7.

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