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

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

PR_COD_1amCom

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* Consultation procedure

*** Consent procedure

***I Ordinary legislative procedure (first reading)

***II Ordinary legislative procedure (second reading)

***III Ordinary legislative procedure (third reading)

(The type of procedure depends on the legal basis proposed by the draft act.)

Amendments to a draft act

Amendments by Parliament set out in two columns

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Amendments by Parliament in the form of a consolidated text

New text is highlighted in bold italics. Deletions are indicated using either the ▌symbol or strikeout. Replacements are indicated by highlighting the new text in bold italics and by deleting or striking out the text that has been replaced.

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DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

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)

– 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,

– having regard to the opinion of the European Economic and Social Committee of ...,

– having regard to the opinion of the Committee of the Regions of ...,

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

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

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.

Amendment 1

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(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.

Or. en

Amendment 2

Proposal for a regulation

Recital 4 b (new)

Text proposed by the Commission

Amendment

(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.

Or. en

Amendment 3

Proposal for a regulation

Recital 5 a (new)

Text proposed by the Commission

Amendment

(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.

Or. en

Amendment 4

Proposal for a regulation

Article 1 – paragraph 1 – point 1 – point a

Regulation (EU) 2017/852

Article 10 – paragraph 2a

Text proposed by the Commission

Amendment

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.;

2a. From 1 January 2027, 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.;

Or. en

Amendment 5

Proposal for a regulation

Article 1 – paragraph 1 – point 1 – point b

Regulation (EU) 2017/852

Article 10 – paragraph 7

Text proposed by the Commission

Amendment

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

7. From 1 January 2027, the manufacture and export of dental amalgam shall be prohibited;

Or. en

Amendment 6

Proposal for a regulation

Article 1 – paragraph 1 – point 1 a (new)

Regulation (EU) 2017/852

Article 19 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

(1a) In Article 19, the following paragraph is added:

“3a. By 30 June 2025, the Commission shall report to the European Parliament and to the Council on the outcome of its assessment regarding the socio-economic impact on patients generally, patients dependent on amalgam-fillings and the impact on dentists of a shift to mercury-free fillings, and regarding the developments in healthcare reimbursement schemes.

The Commission shall, where appropriate, propose measures, together with its report referred to in the first subparagraph.”

Or. en

EXPLANATORY STATEMENT

Extensive research has brought to light the impacts of mercury, making a ban on this substance in specific products a critical step in line with the Union's commitment to environmental protection and public health. While the market readily offers substitutes for certain mercury-added products like lamps, enabling their gradual phase-out, other products cannot be replaced as easily and need to be approached in a more differentiated manner as proposed by the European Commission.

Dental amalgam is still widely used in some Member States. Its complete ban would pose problems for specific patient groups. While there is a clear trend in dental medicine to move away from the use of dental amalgam and to prioritise the use of alternatives instead, the transition cannot be rushed. Appropriate transition periods must be granted in order for doctors to undergo necessary training and for the national health insurance schemes to adjust their reimbursement policies accordingly. On top of that, the ban of dental amalgam must not lead to further economic costs for vulnerable groups. To ensure the best service, doctors must be able to treat patients with specific medical needs with dental amalgam if strictly necessary. Therefore, in my report I support the European Commission’s approach on the exemption in extraordinary circumstances and suggest to slightly push the date of the ban of the use of amalgam back until 1 January 2027. This should allow all Member States and national health insurance schemes to adjust their frameworks appropriately.

I propose to change the date of the ban on the manufacture and export of amalgam to 1 January 2027 as well in order to ensure that the demand of dental amalgam during the transition period can be met.

In general, the supply of dental amalgam for specific needs should be guaranteed, even after the ban on manufacture of dental amalgam takes effect, in order to avoid price increases for patients with specific medical needs.

ANNEX: LIST OF ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The following list is drawn up on a purely voluntary basis under the exclusive responsibility of the rapporteur. The rapporteur has received input from the following entities or persons in the preparation of the draft report:

Entity and/or person

Bundeszahnärztekammer

European Network for Environmental Medicine