Legal provisions of COM(2023)395 - Amendment of Regulation 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to manufacturing, import and export restrictions - Main contents

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dossier	COM(2023)395 - Amendment of Regulation 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to ...
document	COM(2023)395
date	June 13, 2024

Article 1

Regulation (EU) 2017/852 is amended as follows:

(1)

Article 10 is amended as follows:

(a)

the following paragraph is inserted:

‘2a. 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.

Fully respecting Member States’ competence for the organisation and delivery of health services and medical care, and by way of derogation from the first subparagraph, in Member States in which 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 socioeconomically disproportionately affected by the phase-out date of 1 January 2025, dental amalgam may be used for dental treatment until 30 June 2026. Member States shall provide, and make publicly available, reasoned explanations for making use of the derogation, including the appropriate measures to be implemented by 30 June 2026, and notify them to the Commission by 31 August 2024.’

;

(b)

the following paragraph is added:

‘7. From 1 January 2025, the export of dental amalgam shall be prohibited.

From 1 July 2026, the import and manufacturing of dental amalgam shall be prohibited.

By way of derogation from the second subparagraph of this paragraph, the import and manufacturing of dental amalgam shall be allowed for specific medical needs as referred to in paragraph 2a, first subparagraph.’

;

(2)

Article 18 is amended as follows:

(a)

in paragraph 1, first subparagraph, the following points are added:

‘(f)	a summary of the information gathered in accordance with paragraph 1a of this Article as well as the information on the amounts of mercury used for specific medical needs as referred to in Article 10(2a);

(g)	information on the measures implemented on the basis of the Commission guidance on abatement technologies for emissions of mercury and mercury compounds from crematoria referred to in Article 19(2a), point (a).’

;

(b)

the following paragraph is inserted:

‘1a. By 31 May of a given calendar year, importers and manufacturers of dental amalgam shall report to their competent authority for the preceding calendar year the amount of dental amalgam they imported or manufactured pursuant to Article 10(7), third subparagraph.’

;

(3)

Article 19 is amended as follows:

(a)	in paragraph 2, the date ‘31 December 2024’ is replaced by ‘31 December 2029’;

(b)

the following paragraph is inserted:

‘2a. By 31 December 2029, the Commission shall report to the European Parliament and to the Council on:

(a)	the implementation and impact of the guidance, developed by the Commission by 31 December 2025, on abatement technologies for emissions of mercury and mercury compounds from crematoria applied in Member States;

(b)

the need to maintain the exemption from the prohibition on the use of dental amalgam referred to in Article 10(2a), first subparagraph, taking into account the impact on the health of patients generally and of patients dependent on amalgam fillings, and the need to maintain the derogation for the import and manufacturing of dental amalgam as referred to in Article 10(7), third subparagraph;

(c)	the developments under the Convention as regards the phase-out of illegal mercury use in cosmetics, taking into account information provided by Parties to the Convention in line with Decision MC-5/5 of the Conference of the Parties on the preparation of a report on cosmetics;

(d)	the need to phase out remaining mercury uses;

(e)	the need to expand the list of mercury waste sources set out in Article 11;

(f)	the need to expand the list of mercury compounds set out in Annex I, by adding, for example, mercuric azanide chloride (HgNH2Cl).’

;

(c)	paragraph 3 is replaced by the following: ‘3. The Commission shall, if appropriate, present a legislative proposal together with the reports referred to in this Article.’ ;

(4)	Annex II is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.