Considerations on 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
 
(1)In accordance with Article 19(1) of Regulation (EU) 2017/852 of the European Parliament and of the Council 41 , the Commission was to assess and report on the need to regulate, at Union level, emissions of mercury and of its compounds (‘mercury’) from crematoria, the feasibility of phasing-out the use of dental amalgam for all members of the population in the long term, and preferably by 2030, and on the environmental benefits and the feasibility of banning the manufacture and export of other mercury-added products, which are prohibited from being placed on the Union market and imported into the Union.  

(2)Following the conclusion reached by the Commission in its report 42  and its subsequent Impact Assessment 43 , the Commission found it appropriate to present a legislative proposal, in accordance with Article 19(3) of Regulation (EU) 2017/852, 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.  

(3)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, the mercury-free alternatives have become economically and technically feasible and are readily available.

(4)Considering the availability of mercury-free alternatives, it is appropriate to prohibit the use of dental amalgam for dental treatment of all members of the population, whilst maintaining the possibility of using dental amalgam for patients with specific medical needs. In order to prevent dental amalgam, which is  prohibited on the Union market, being manufactured for export from the Union, it is necessary to prohibit the manufacture and export of dental amalgam. Article 10 of Regulation (EU) 2017/852 should therefore be amended accordingly.

(5)Article 4(1) of Directive 2011/65/EU of the European Parliament and of the Council 44  prohibits the placing on the Union market and import into the Union of certain electrical and electronic equipment containing mercury. Annex III to that Directive lists, among other items, certain mercury-added lamps exempted from the said prohibition until the dates specified therein. That exemption already expired on 13 April 2016 for non-linear halophosphate lamps, and it  will expire on 24 February 2023 or on 24 February 2027 for certain compact fluorescent lamps, linear fluorescent lamps and high pressure sodium (vapour) lamps for general lighting purposes, as well as for non-linear tri-band phosphor fluorescent lamps. In addition, certain linear fluorescent lamps for general lighting purposes are listed for a future prohibition in Decision MC-4/3 adopted at the fourth meeting, held from 21 to 25 March 2022, of the Conference of the Parties to the Minamata Convention on Mercury 45 . That Decision was supported by the Union by means of Council Decision (EU) 2022/549 46 .  As some of those lamps are currently not covered by Part A of Annex II to Regulation (EU) 2017/852, they should, for the sake of coherence, be included therein to prohibit their manufacturing and export from the dates in line with Annex III of Directive 2011/65/EU and the most ambitious dates included in Decision MC-4/3.

(6)Regulation (EU) 2017/852 should therefore be amended accordingly,