Changes from report parliamentary committee draft to plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

▸7 unchanged paragraphs

on the proposal for a regulation of the European Parliament and of the Council 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 products subject to manufacturing, import and export restrictions

(COM(2023)0395 – C90309/2023 – 2023/0272(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0395),

– having regard to Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90309/2023),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

Changed– having regard to the opinion of the European Economic and Social Committee of ...,26 October 2023,

Change 1

Changed– having regard to the opinionafter ofconsulting the Committee of the Regions of ...,Regions,

– having regard to Rule 59 of its Rules of Procedure,

Changed– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A90000/2023),(A9-0002/2024),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Change 2

RemovedRecital 4 a (new): (4a) Given the different dental practices and dentistry skills in the Member States, a short transitional period for the phase-out of dental amalgam is appropriate to allow for professional training of dentists so they are able to adjust to new techniques. Such a transitional period would also allow for the adjustment of national reimbursement systems in Member States where the variation of the price of materials used is high.

AddedRecital 1 a (new): (1a) 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.

RemovedRecital 4 b (new): (4b) To limit the socio-economic impact of a shift to mercury-free fillings on the costs of dental care for patients and on dentists, Member States should endeavour to ensure that appropriate reimbursement is available for mercury-free alternatives.

AddedRecital 4: (4) Considering the availability of mercury-free alternatives, the affordability of alternative materials and the current transition to mercury-free fillings in many Member States, 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. The transition to mercury-free alternatives for dental fillings has already advanced in many Member States, thus highlighting the feasibility of and need for that prohibition as a cost-effective way of preventing additional mercury pollution. 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.

RemovedRecital 5 a (new): (5a) The limited supply of dental amalgam due to the manufacturing prohibition in the Union could increase the costs for those patients who on account of their specific needs are dependent on amalgam-fillings. The Commission should therefore assess the impact of the manufacturing prohibition on such groups in a dedicated report in order to monitor the price developments and prevent further pressure on economically weak citizens.

AddedRecital 4 a (new): (4a) Crematoria are a significant source of releases of mercury into the atmosphere and even with a phase-out of dental amalgam, crematoria will continue to contribute to mercury pollution of air, water, and soil. It is necessary to collect information on measures implemented in Member States, and to develop guidelines for crematoria, in order to achieve appropriate pollution prevention and to mitigate the impact on the environment and human health.

AddedRecital 5: (5) Article 4(1) of Directive 2011/65/EU of the European Parliament and of the Council44 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, on 24 February 2023 for certain compact fluorescent lamps, and on 24 August 2023 for linear fluorescent lamps for general lighting purposes. For non-linear triband phosphor fluorescent lamps, the exemption expires on 24 February 2025. The exemption for most high pressure sodium (vapour) lamps for general lighting purposes with an improved colouring index expired on 24 February 2023, whereas for the remaining ones as well as for other high pressure sodium (vapour) lamps for general lighting purposes, the exemption will expire on 24 February 2025. 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 Mercury45 . That Decision was supported by the Union by means of Council Decision (EU) 2022/54946. As it is appropriate to prohibit the export from the Union of the remaining mercury-added lamps as soon as possible, and some of thos…

AddedRecital 5 a (new): (5a) In light of the detrimental effects of mercury and mercury compounds on human health and the environment, exposure and emissions should be further minimised as much as possible. Recent reports show that European companies are manufacturing and exporting mercury compounds which are used for non-allowed uses, particularly in cosmetics. Therefore, the Commission should report on the implementation and enforcement of the Minamata Convention, in particular with regard to the use of mercury and mercury compounds in cosmetics and to the manufacturing, import and export of mercury and mercury compounds for non-allowed uses. The Commission should further assess the remaining uses of mercury, for example in porosimetry, lighthouses and vaccines, as well as the need to amend the list of large waste sources, and, where appropriate, suggest measures to phase out such uses and regulate manufacture, import and export for such purposes.

AddedRecital 5 b (new): (5b) Considering the lack of proper collection systems for mercury-added products in non-electronic and electronic waste, secondary mercury emissions from landfills and waste incinerators continue to occur, which points to the need to collect such products separately and in an environmentally sound manner.

Regulation (EU) 2017/852

Change 3

ChangedArticle 1 – paragraph 1 – point 1 – point a, Article 10 – paragraph 2a: 2a. From 1 January 2027,2025, 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 theduly justified specific medical needs of the patient.;

Regulation (EU) 2017/852

Change 4

RemovedArticle 1 – paragraph 1 – point 1 – point b, Article 10 – paragraph 7: 7. From 1 January 2027, the manufacture and export of dental amalgam shall be prohibited;

AddedArticle 1 – paragraph 1 – point 1 a (new), Article 11 – paragraph 1 a (new): (1a) In Article 11, the following paragraph is added: / 'Mercury-added products that are still in circulation and that can no longer be used shall be considered waste and shall be collected separately and in an environmentally sound manner.’

Regulation (EU) 2017/852

Change 5

ChangedArticle 1 – paragraph 1 – point 1 ab (new), Article 1918 – paragraph 3 a (new): (1a)(1b) In Article 19,18, the following paragraph is added: / “3a.‘3a. By 3031 June 2025, the Commission shall report to the European Parliament2024, and to theevery Counciltwo onyears thethereafter, outcomeMember ofStates itsshall assessmentreport regardingto the socio-economic impact on patients generally, patients dependentCommission on amalgam-fillingsplanned and the impact on dentists of aimplemented shiftmeasures to mercury-free fillings, and regardingreduce themercury developmentsemissions inand healthcarereleases reimbursementfrom schemes.crematoria. / The Commission shall, whereshall appropriate,make proposethe measures,data togetheron withmeasures itsreported reportby referredMember toStates in accordance with the first subparagraph.”subparagraph publicly available.’