Mercury Regulation

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.

02017R0852-20231016 → 02017R0852-20240730

Article 18 Report 1. By 1 January 2020 and at appropriate intervals thereafter, Member States shall prepare, provide to the Commission and make publicly available on the internet a report with the following: (a) information concerning the implementation of this Regulation; (b) information needed for the fulfilment by the Union of its reporting obligation under Article 21 of the Convention; (c) a summary of the information gathered in accordance with Article 12 of this Regulation; (d) information regarding mercury located in their territories: (i) a list of sites where stocks of more than 50 metric tonnes of mercury other than mercury waste are located as well as the amount of mercury at each site; (ii) a list of sites where more than 50 metric tonnes of mercury waste is accumulated as well as the amount of mercury waste at each site; and (e) a list of sources supplying more than 10 metric tonnes of mercury per year, where Member States are made aware of such sources. sources; (f) a summary of the information gathered in accordance with paragraph 1a of this Article as well as the information on the amounts of mercury used for specific medical needs as referred to in Article 10(2a); and (g) information on the measures implemented on the basis of the Commission guidance on abatement technologies for emissions of mercury and mercury compounds from crematoria referred to in Article 19(2a), point (a). Member States may decide not to make any of the information referred to in the first subparagraph publicly available on any of the grounds mentioned in Article 4(1) and (2) of Directive 2003/4/EC of the European Parliament and of the Council Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26)., subject to the second subparagraph of Article 4(2) of that Directive. 1a. By 31 May of a given calendar year, importers and manufacturers of dental amalgam shall report to their competent authority for the preceding calendar year the amount of dental amalgam they imported or manufactured pursuant to Article 10(7), third subparagraph. 2. For the purposes of the report referred to in paragraph 1, the Commission shall make an electronic reporting tool available to the Member States. The Commission shall adopt implementing acts to establish appropriate questionnaires in order to specify the content, the information and the key performance indicators needed to meet the requirements under paragraph 1 as well as the format and the frequency of the report referred to in paragraph 1. Those questionnaires shall not duplicate reporting obligations of the Parties to the Convention. The implementing acts referred to in this paragraph shall be adopted in accordance with the examination procedure referred to in Article 22(2). 3. The Member States shall, without delay, make available to the Commission reports they provide to the Secretariat of the Convention.

02017R0852-20231016 → 02017R0852-20240730

Article 19 Review 1. By 30 June 2020, the Commission shall report to the European Parliament and to the Council on the outcome of its assessment regarding: (a) the need for the Union to regulate emissions of mercury and mercury compounds from crematoria; (b) the feasibility of a phase out of the use of dental amalgam in the long term, and preferably by 2030, taking into account the national plans referred to in Article 10(3) and whilst fully respecting Member States' competence for the organisation and delivery of health services and medical care; and (c) the environmental benefits and the feasibility of a further alignment of Annex II with relevant Union legislation regulating the placing on the market of mercury-added products. 2. By 31 December 2024, 2029, the Commission shall report to the European Parliament and to the Council on the implementation and the review of this Regulation, inter alia, in the light of the effectiveness evaluation undertaken by the Conference of the Parties to the Convention and of the reports provided by the Member States in accordance with Article 18 of this Regulation and Article 21 of the Convention. 2a. By 31 December 2029, the Commission shall report to the European Parliament and to the Council on: (a) the implementation and impact of the guidance, developed by the Commission by 31 December 2025, on abatement technologies for emissions of mercury and mercury compounds from crematoria applied in Member States; (b) the need to maintain the exemption from the prohibition on the use of dental amalgam referred to in Article 10(2a), first subparagraph, taking into account the impact on the health of patients generally and of patients dependent on amalgam fillings, and the need to maintain the derogation for the import and manufacturing of dental amalgam as referred to in Article 10(7), third subparagraph; (c) the developments under the Convention as regards the phase-out of illegal mercury use in cosmetics, taking into account information provided by Parties to the Convention in line with Decision MC-5/5 of the Conference of the Parties on the preparation of a report on cosmetics; (d) the need to phase out remaining mercury uses; (e) the need to expand the list of mercury waste sources set out in Article 11; (f) the need to expand the list of mercury compounds set out in Annex I, by adding, for example, mercuric azanide chloride (HgNH2Cl). 3. The Commission shall, if appropriate, present a legislative proposal together with its the reports referred to in paragraphs 1 and 2. this Article.

02017R0852-20231016 → 02017R0852-20240730

ANNEX II Mercury-added products referred to in Article 5 Part A — Mercury-added products Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). Mercury-added products Date from which the export, import and manufacturing of the mercury-added products are prohibited 1. Batteries or accumulators that contain more than 0,0005 % of mercury by weight. 31.12.2020 2. Switches and relays, except very high accuracy capacitance and loss measurement bridges and high frequency radio frequency switches and relays in monitoring and control instruments with a maximum mercury content of 20 mg per bridge, switch or relay. 31.12.2020 3. Compact fluorescent lamps (CFLs) for general lighting purposes: (a) CFL.i ≤ 30 watts with a mercury content exceeding 2,5 mg per lamp burner; (b) CFL.ni ≤ 30 watts with a mercury content exceeding 3,5 mg per lamp burner. 31.12.2018 3a. Compact fluorescent lamps with an integrated ballast (CFL.i) for general lighting purposes that are ≤ 30 watts with a mercury content not exceeding 2,5 mg per lamp burner. 31.12.2025 3b. All other compact fluorescent lamps (CFLs) for general lighting purposes that are not included in entries 3 and 3a. 31.12.2025 4. The following linear fluorescent lamps (LFLs) for general lighting purposes: (a) Triband phosphor < 60 watts with a mercury content exceeding 5 mg per lamp; (b) Halophosphate phosphor ≤ 40 watts with a mercury content exceeding 10 mg per lamp. 31.12.2018 4a. Tri-band phosphor lamps for general lighting purposes that are not included in entry 4, point (a). 31.12.2026 4b. Halophosphate phosphor lamps for general lighting purposes that are not included in entry 4, point (b). 31.12.2025 4c. Non-linear tri-band phosphor lamps. 31.12.2026 4d. Non-linear halophosphate phosphor lamps. 31.12.2025 5. High pressure mercury vapour lamps (HPMVs) for general lighting purposes. 31.12.2018 5a. High pressure sodium (vapour) lamps (HPS) for general lighting purposes with: (a) P ≤ 105 W exceeding 16 mg Hg; (b) 105 W < P ≤ 155 W exceeding 20 mg Hg; (c) P > 155 W exceeding 25 mg Hg. 31.12.2025 6. The following mercury-added cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFLs and EEFLs) for electronic displays: (a) short length (≤ 500 mm) with mercury content exceeding 3,5 mg per lamp; (b) medium length (> 500 mm and ≤ 1500 mm) with mercury content exceeding 5 mg per lamp; (c) long length (> 1500 mm) with mercury content exceeding 13 mg per lamp. 31.12.2018 6a. Cold cathode fluorescent lamps (CCFL) and external electrode fluorescent lamps (EEFL) of all lengths for electronic displays, that are not included in entry 6. 31.12.2025 7. Cosmetics with mercury and mercury compounds, except those special cases included in entries 16 and 17 of Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council . 31.12.2020 8. Pesticides, biocides and topical antiseptics. 31.12.2020 9. The following non-electronic measuring devices: (a) barometers; (b) hygrometers; (c) manometers; (d) thermometers and other non-electrical thermometric applications; (e) sphygmomanometers; (f) strain gauges to be used with plethysmographs; (g) mercury pycnometers; (h) mercury metering devices for determination of the softening point. This entry does not cover the following measuring devices: non-electronic measuring devices installed in large-scale equipment or those used for high precision measurement where no suitable mercury-free alternative is available; measuring devices more than 50 years old on 3 October 2007; measuring devices which are to be displayed in public exhibitions for cultural and historical purposes. 31.12.2020 10. The following electrical and electronic measuring devices except those installed in large-scale equipment or those used for high precision measurement where no suitable mercury-free alternative is available: (a) melt pressure transducers; (b) melt pressure transmitters; (c) melt pressure sensors. 31.12.2025 11. Other mercury-added products: (a) Mercury vacuum pumps; (b) Tyre balancers and wheel weights; (c) Photographic film and paper; (d) Propellant for satellites and spacecraft. 31.12.2025 Part B — Additional products excluded from the list in Part A of this Annex Switches and relays, cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFLs and EEFLs) for electronic displays and measuring devices, when they are used to replace a component of larger equipment and provided that no feasible mercury-free alternative for that component is available, in accordance with Directive 2000/53/EC of the European Parliament and of the Council Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34). and Directive 2011/65/EU.