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

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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 EN
date July 14, 2023


Contents

Article 1 -

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


(1)Article 10 is amended as follows:

(a)the following paragraph 2a is inserted:


‘2a. From 1 January 2025, 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 specific medical needs of the patient.’;


(b)the following paragraph 7 is added:

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


(2)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.