Art. 10

02017R0852-20231016 → 02017R0852-20240730

Article 10 Dental amalgam 1. From 1 January 2019, dental amalgam shall only be used in pre-dosed encapsulated form. The use of mercury in bulk form by dental practitioners shall be prohibited. 2. From 1 July 2018, dental amalgam shall not be used for dental treatment of deciduous teeth, of children under 15 years and of pregnant or breastfeeding women, except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient. 2a. From 1 January 2025, dental amalgam shall not be used for dental treatment in the Union, except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient. Fully respecting Member States’ competence for the organisation and delivery of health services and medical care, and by way of derogation from the first subparagraph, in Member States in which dental amalgam is the only publicly reimbursed material at a rate of at least 90 % under national law for patients who are not eligible for other reimbursed materials of dental filling and persons with low income are socioeconomically disproportionately affected by the phase-out date of 1 January 2025, dental amalgam may be used for dental treatment until 30 June 2026. Member States shall provide, and make publicly available, reasoned explanations for making use of the derogation, including the appropriate measures to be implemented by 30 June 2026, and notify them to the Commission by 31 August 2024. 3. By 1 July 2019, each Member State shall set out a national plan concerning the measures it intends to implement to phase down the use of dental amalgam. Member States shall make their national plans publicly available on the internet and shall transmit them to the Commission within one month of their adoption. 4. From 1 January 2019, operators of dental facilities in which dental amalgam is used or dental amalgam fillings or teeth containing such fillings are removed, shall ensure that their facilities are equipped with amalgam separators for the retention and collection of amalgam particles, including those contained in used water. Such operators shall ensure that: (a) amalgam separators put into service from 1 January 2018 provide a retention level of at least 95 % of amalgam particles; (b) from 1 January 2021, all amalgam separators in use provide the retention level specified in point (a). Amalgam separators shall be maintained in accordance with the manufacturer's instructions to ensure the highest practicable level of retention. 5. Capsules and amalgam separators complying with European standards, or with other national or international standards that provide an equivalent level of quality and retention, shall be presumed to satisfy the requirements set out in paragraphs 1 and 4. 6. Dental practitioners shall ensure that their amalgam waste, including amalgam residues, particles and fillings, and teeth, or parts thereof, contaminated by dental amalgam, is handled and collected by an authorised waste management establishment or undertaking. Dental practitioners shall not release directly or indirectly such amalgam waste into the environment under any circumstances.7. From 1 January 2025, the export of dental amalgam shall be prohibited. From 1 July 2026, the import and manufacturing of dental amalgam shall be prohibited. By way of derogation from the second subparagraph of this paragraph, the import and manufacturing of dental amalgam shall be allowed for specific medical needs as referred to in paragraph 2a, first subparagraph.