Changes from report parliamentary committee draft to plenary report

Change 1

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

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.

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.;

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.’

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.’

Change 6

AddedRegulation (EU) 2017/852

RemovedExtensive 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.

AddedArticle 1 – paragraph 1 – point 1 c (new), Article 19 – paragraph 1 a (new): (1c) In Article 19, the following paragraph is inserted: / ‘1a. By 31 December 2025, the Commission shall report to the European Parliament and to the Council on the reduction of mercury emissions and releases from crematoria on the basis of the reporting referred to in Article 18(3a) and, where appropriate, draft guidelines on the abatement technologies to control and reduce mercury emissions and releases from crematoria, taking into account existing guidelines.’

RemovedDental 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.

AddedRegulation (EU) 2017/852

RemovedI 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.