Article 1 Subject matter and objective
This Regulation establishes measures and conditions concerning the use and storage of and trade in mercury, mercury compounds and mixtures of mercury, and the manufacture and use of and trade in mercury-added products, and the management of mercury waste, in order to ensure a high level of protection of human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds. Member States may, where appropriate, apply stricter requirements than those laid down in this Regulation, in accordance with the TFEU.
Article 2 Definitions
For the purposes of this Regulation, the following definitions apply: (1) ‘mercury’ means metallic mercury (Hg, CAS RN 7439-97-6); (2) ‘mercury compound’ means any substance consisting of atoms of mercury and one or more atoms of other chemical elements that can be separated into different components only by chemical reactions; (3) ‘mixture’ means a mixture or solution composed of two or more substances; (4) ‘mercury-added product’ means a product or product component that contains mercury or a mercury compound that was intentionally added; (5) ‘mercury waste’ means metallic mercury that qualifies as waste as defined in point (1) of Article 3 of Directive 2008/98/EC; (7) ‘import’ means the physical introduction into the customs territory of the Union of mercury, mercury compounds, mixtures of mercury and mercury-added products that are placed under a customs procedure other than the external Union transit procedure for movement of goods through the customs territory of the Union; (8) ‘disposal’ means disposal as defined in point (19) of Article 3 of Directive 2008/98/EC; (9) ‘primary mercury mining’ means mining in which the principal material sought is mercury; (10) ‘conversion’ means the chemical transformation of the physical state of mercury from a liquid state to mercury sulfide or a comparable chemical compound that is equally or more stable and equally or less soluble in water and that presents no greater environmental or health hazard than mercury sulfide; (11) ‘placing on the market’ means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market.
Article 3 Export restrictions
1. The export of mercury shall be prohibited. 2. The export of the mercury compounds and of the mixtures of mercury listed in Annex I shall be prohibited as from the dates set out therein. 3. By way of derogation from paragraph 2, the export of the mercury compounds listed in Annex I for the purposes of laboratory-scale research or laboratory analysis shall be allowed. 4. The export, for the purpose of reclaiming mercury, of mercury compounds and of mixtures of mercury that are not subject to the prohibition laid down in paragraph 2 shall be prohibited.
Article 4 Import restrictions
1. The import of mercury and the import of the mixtures of mercury listed in Annex I, including mercury waste from any of the large sources referred to in points (a) to (d) of Article 11, for purposes other than disposal as waste shall be prohibited. Such import for disposal as waste shall only be allowed where the exporting country has no access to available conversion capacity within its own territory. Without prejudice to Article 11 and by way of derogation from the first subparagraph of this paragraph, the import of mercury and the import of the mixtures of mercury listed in Annex I for a use allowed in a Member State shall be allowed where the importing Member State has granted written consent to such import in either of the following circumstances: (b) the exporting country not being a Party to the Convention has provided certification that the mercury is not from primary mercury mining. Without prejudice to any national measures adopted in accordance with the TFEU, a use allowed pursuant to Union legislation shall be deemed to be a use allowed in a Member State for the purposes of this paragraph. 2. The import of mixtures of mercury that do not fall under paragraph 1 and of mercury compounds, for the purpose of reclaiming mercury, shall be prohibited. 3. The import of mercury for use in artisanal and small-scale gold mining and processing shall be prohibited. 4. Where the import of mercury waste is allowed in accordance with this Article, Regulation (EC) No 1013/2006 shall continue to apply in addition to the requirements of this Regulation.
Article 5 Export, import and manufacturing of mercury-added products
1. Without prejudice to stricter requirements set out in other applicable Union legislation, the export, import and manufacturing in the Union of the mercury-added products set out in Annex II shall be prohibited as from the dates set out therein. 2. The prohibition laid down in paragraph 1 shall not apply to any of the following mercury-added products: (a) products that are essential for civil protection and military uses; (b) products for research, for calibration of instrumentation, or for use as a reference standard.
Article 6 Forms for import and export
The Commission shall adopt decisions, by means of implementing acts, to specify forms to be used for the purpose of implementing Articles 3 and 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2).
Article 7 Industrial activities
1. The use of mercury and mercury compounds in the manufacturing processes listed in Part I of Annex III shall be prohibited as from the dates set out therein. 2. The use of mercury and mercury compounds in the manufacturing processes listed in Part II of Annex III shall only be allowed subject to the conditions set out therein. 3. Interim storage of mercury and of the mercury compounds and mixtures of mercury listed in Annex I to this Regulation shall be carried out in an environmentally sound manner, in accordance with the thresholds and requirements set out in Directive 2012/18/EU of the European Parliament and of the Council ( 1 ) and in Directive 2010/75/EU. In order to ensure the uniform application of the obligation laid down in the first subparagraph of this paragraph, the Commission may adopt implementing acts setting out technical requirements for environmentally sound interim storage of mercury, mercury compounds and mixtures of mercury in line with decisions adopted by the Conference of the Parties to the Convention in accordance with Article 10(3) and Article 27 of the Convention, provided that the Union has supported the decision concerned by means of a Council decision adopted in accordance with Article 218(9) TFEU. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2) of this Regulation.
Article 8 New mercury-added products and new manufacturing processes
1. Economic operators shall not manufacture or place on the market mercury-added products that were not being manufactured prior to 1 January 2018 (‘new mercury-added products’) unless authorised to do so by means of a decision taken pursuant to paragraph 6 of this Article or allowed to do so under Directive 2011/65/EU of the European Parliament and of the Council ( 2 ). The first subparagraph shall not apply to any of the following: (a) equipment which is necessary for the protection of the essential interests of the security of Member States, including arms, munitions and war material intended for specifically military purposes; (b) equipment designed to be sent into space; (c) technical improvements made to or the redesign of mercury-added products that were being manufactured prior to 1 January 2018 provided that such improvements or redesign lead to less mercury being used in those products. 2. Economic operators shall not use manufacturing processes involving the use of mercury or mercury compounds that were not processes used prior to 1 January 2018 (‘new manufacturing processes’) unless authorised to do so by means of a decision taken pursuant to paragraph 6. The first subparagraph of this paragraph shall not apply to processes manufacturing or using mercury-added products other than those subject to the prohibition laid down in paragraph 1. 4. The Member State concerned shall forward to the Commission the notification received from the economic operator if it considers on the basis of its own assessment of the information provided therein that the criteria referred to in the first subparagraph of paragraph 6 are fulfilled. The Member State concerned shall inform the Commission of cases in which it considers that the criteria referred to in the first subparagraph of paragraph 6 were not fulfilled. 5. Where the Member State forwards a notification pursuant to the first subparagraph of paragraph 4 of this Article, the Commission shall immediately make the notification available to the committee referred to in Article 22(1). 6. The Commission shall examine the notification received and assess whether it has been demonstrated that the new mercury-added product or new manufacturing process would provide significant environmental or health benefits and pose no significant risks either to the environment or to human health, and that no technically practicable mercury-free alternatives providing such benefits are available. The Commission shall inform the Member States of the outcome of the assessment. The Commission shall adopt decisions, by means of implementing acts, specifying whether the relevant new mercury-added product or new manufacturing process is authorised. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 22(2). 7. By 30 June 2018, the Commission shall make publicly available on the internet an inventory of manufacturing processes involving the use of mercury or mercury-compounds that were processes used prior to 1 January 2018 and of mercury-added products that were being manufactured prior to 1 January 2018 and of any applicable marketing restrictions.
Article 9 Artisanal and small-scale gold mining and processing
1. Artisanal and small-scale gold mining and processing in which mercury amalgamation is used to extract gold from ore shall be prohibited. 2. Without prejudice to paragraph 1 of this Article and to Article 16, where there is evidence of there being more than isolated cases of non-compliance with the prohibition laid down in paragraph 1 of this Article, the competent authority of the Member State concerned shall develop and implement a national plan in accordance with Annex IV.
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. 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.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Mercury is a highly toxic element and a major risk to the environment and human health. It is a potent neurotoxin inducing permanent brain and kidney damage in adults and affecting foetal and early childhood development. Hence, mercury has been classified under Union law as being toxic for reproduction, fatal if inhaled, causing damage to all organs through prolonged or repeated exposure and very toxic for aquatic life with long lasting adverse effects 1 . Considering the risk posed by mercury to both human health and the environment, the Commission developed in 2005 a dedicated Mercury Strategy 2 as reviewed in 2010 3 inviting the Union to address all facets of mercury , including its use in products . As a result, t he Council of the European Union concluded as follows: ‘ Mercury-added products, where viable alternatives exist, should be phased out as rapidly and as completely as possible, with the ultimate goal that all mercury-added products should be phased-out, taking into due account technical and economic circumstanc es and the needs for scientific research and development .’ 4 The proposal also falls within a broader policy context by contributing to meeting the objectives of the European Green Deal 5 , the EU Chemicals Strategy for Sustainability 6 and the Zero Pollution Action Plan (hereafter; ‘ZPAP’) 7 adopted under it. In particular it aims to fulfil the Union’s commitment to lead by example and ensure that hazardous chemicals banned in the Union are not produced for export in accordance with Flagship 8 of the ZPAP on the minimis ation of the Union’s external pollution footprin t , including by amending relevant legislation. Furthermore, this initiative contributes to the development of a new Union framework for sustainable products 8 , as well as to the EU decarbonisation agenda 9 by promoting the substitution of mercury-containing lamps with more energy-efficient lighting alternatives such as light-emitting diode (LED) lamps. Regulation (EU) 2017/852 10 (hereinafter, ‘the Mercury Regulation ’) is the main instrument of Union law dedicated to mercury and mercury compounds (hereafter, ‘mercury’ or ‘Hg’) addressing the entire life-cycle of this substance from primary mercury mining to the final disposal of mercury waste and transpos ing the Minamata Convention on Mercury (hereafter, ‘Minamata Convention’ or ‘Convention’) 11 ratified by the Union in May 2017 12 and all the Member States . O ne key aspect addressed by t he Mercury Regulation concerns mercury use in products by establishing prohibitions on the manufacture, import and export of a range of mercury-added products (hereafter, ‘MAPs’) 13 , hence complement ing provisions established in other Union instruments setting restrictions on the placing on the market and import of MAPs . W ith a view to establishing a mercury-free Europe, t he p roposal addresses the last intentional remaining uses of mercury in products in the Union . According to t he review clause established in Article 19 14 of the Mercury Regulation , the Commission is asked to report to the European Parliament and to the Council on the outcome of its assessment regarding: (a) the feasibility of a total phase - out of the use of dental amalgam preferably by 2030 and the need for the EU to regulate associated mercury emissions from crematoria ; (b) the environmental benefits and the feasibility of prohibiting the manufacturing, import and export of other remaining M APs, which are already or will soon be banned from being placed on the market in accordance with other Union instruments. Paragraph 3 of Article 19 provides that the Commission shall, if appropriate, present a legislative proposal based on the above-mentioned assessment. The Commission adopted in August 2020 15 its Review R eport on the feasibility of phasing out the use of mercury in dental amalgam and other products . Both this report and the subsequent Commission’s impact assessment pointed to the appropriateness of presenting a legislative proposal to phas e out the use of dental amalgam and to restrict the manufacture and export of certain mercury-containing lamps. Dental amalgam is the largest remaining intentional use of mercury in the Union estimated at around 40 t in 2019. Article 10(2) of the Mercury Regulation already sets a partial ban on the use of dental amalgam by prohibiting it since 1 January 2018 for dental treatment of deciduous teeth and of vulnerable members of the population (i.e., children under the age of 15 and pregnant and breastfeeding women), except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient. In addition, under Article 10(3), Member States had to develop by 1 July 2019 a national plan on the phase-down on the use of dental amalgam. As regards other MAPs , Article 5 prohibits the manufacture, import and export of the MAPs listed in Annex II as from the phase-out dates specified therein (as from 31 December 2018 or 2020), except when they are deemed essential for civil protection and military uses or to those used for research, calibration of instruments or as a reference standard. The MAPs referred to in Annex II are products for which technically and economically feasible mercury-free alternatives are available. Annex II currently lists the following six types of MAPs: · batteries and accumulators, · certain switches and relays, · a range of mercury- containing lamps, including certain compact fluorescent lamps (CFLs) and linear fluorescent lamps (LFLs) for general lighting purposes, mercury-added cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFLs and EEFLs) for electronic displays and high-pressure mercury vapour lamps (HPMVs) for general lighting purposes, · cosmetics (except some eye products), · pesticides, biocides and topical antiseptics , · certain non-electronic measuring devices (e.g. , thermometers, barometers). At the time of the adoption of the Mercury Regulation ( May 2017 ) , the a bove-listed MAPs contained in Annex II were products that had already been prohibited from being placed on the market and imported in the Union in accordance with other Union instruments, including Directive (EC) 2006/66 on batteries 16 , Regulation (EC) 1907/2006 REACH 17 , Regulation (EC) 1223/2009 on cosmetic products 18 and Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (hereafter, ‘RoHS Directive’) 19 . However, considering the increasing availability of technically and economically feasible mercury-free alternatives, additional MAPs have in the meantime been subject to new restrictions on their placing on the market and import under the RoHS Directive. In this respect, the continued manufacture and export of those MAPs is a significant cause of mercury pollution, especially in third countries who often lack resources to ensure the environmental sound management of waste and where EU-made products therefore add to the national burden of hazardous products and increase the risk for local retailers, end-users, and inhabitants. In 2018, 13-38 t of mercury were exported from the Union in the form of dental amalgam as well as 0.5 t of mercury in lamps (equivalent to 156 million mercury-containing lamps) in 2020. Hence, the proposal aims to ensure coherence between the Mercury Regulation and the RoHS Directive and thereby contributing to the Union’s commitments under Flagship 8 of the Zero Pollution Action Plan by phasing out the manufacturing and export of the following mercury-containing lamps: – C urrent Annex II (Part A) ( entry 3) to the Mercury Regulation prohibits the manufacturing, import and export of the following CFLs for general lighting purposes : (i) CFL.i ≤ 30 watts with Hg content > 2,5 mg per lamp burner and (ii) CFL.ni 20 ≤ 30 watts with Hg content > 3,5 mg per lamp burner . A s a follow-up to the adoption of Commission Delegated Directive (EU) 2022/276 21 amending Annex III (entries 1, 1(a), 1(b), 1(c), 1(d) and 1(e) ) to the RoHS Directive, as from 24 February 2023, a ll CFLs for general lighting purposes can only be placed on the Union market and imported if they contain zero mercury content. – C urrent Annex II (Part A) ( entry 4 , point a) to the Mercury Regulation prohibits the manufacturing, import and export of t riband phosphor LFLs for general lighting purposes of < 60 W with Hg content > 5 mg per lamp burner . A s a follow-up to the adoption of Commission Delegated Directive (EU) 2022/284 22 amending Annex III (entries 2(a), 2(a)(1), 2(a)(2), 2(a)(3), 2(a)(4) and 2(a)(5)) to the RoHS Directive, as from 24 February 2023 or 24 August 2023, a ll triband phosphor LFLs for general lighting purposes can only be placed on the Union market and imported if they contain zero mercury content. – Whereas current Annex II to the Mercury Regulation does not cover non-linear triband phosphor fluorescent lamps , Commission Delegated Directive (EU) 2022/282 23 amending Annex III (entr y 2(b)(3) ) to the RoHS Directive only allows, as from 24 February 202 5 , the placing on the EU market and import of such lamps i f they contain zero mercury content. – C urrent Annex II (Part A) (entry 4 , point b) to the Mercury Regulation prohibits the manufacturing, import and export of h alophosphate phosphor (LFLs) of < 40 watts with Hg content > 10 mg per lamp burner . Annex III (entry 2(b)(1)) to the RoHS Directive only allows, as from 13 April 2012, the placing on the Union market and import of linear halophosphate phosphor lamps with tube diameter > 28 mm (e.g., T10 and T12) if they contain zero mercury content. – Whereas current Annex II to the Mercury Regulation does not cover non-linear halophosphate phosphor fluorescent lamps , Annex III (entry 2(b)(2)) to the RoHS Directive only allows, as from 13 April 2016, the placing on the EU market and import of non-linear halophosphate phosphor lamps if they contain zero mercury content. – Whereas c u rrent Annex II to the Mercury Regulation does not cover high pressure sodium (vapour) lamps (HPS) , Commission Delegated Directive (EU) 2022/283 24 amending Annex III (entries 4(b)(I), 4(b)(II) and 4(b)(III)) to the RoHS Directive only allows, as from 24 February 2023, the placing on the EU market and import of HPS with improved colour rendering index Ra > 60: P ≤ 155 W, > 60: 155 W < P ≤ 405 W or > 60: P > 405 W if they contain zero mercury content. In addition, not only does t he proposal aim at ensuring coherence within Union law on MAPs, but it also seeks to implement D ecision MC-4/3 of the Minamata Convention adopted by Parties at the fourth meeting of the Conferences of the Parties to that Convention in March 2022 (hereafter, ‘ COP4 ’) , amending, inter alia , Annex A (Part I) to the Convention on the list of other MAPs that are subject to a manufacture and international trade prohibition 25 . De facto , in aligning Annex II of the Mercury Regulation with RoHS, this proposal includes into that Regulation lamps covered by Decision MC-4/3 (paragraph 5) to be considered at COP5 (November 2023), thereby putting the Union in a leadership position for future international negotiations. This concerns the following lamps: · Halophosphate phosphor LFLs > 40 watts; · Halophosphate phosphor LFLs ≤ 40 watts with a Hg content not exceeding 10 mg per lamp; · Triband phosphor LFLs < 60 watts with a Hg content not exceeding 5 mg/lamp Whilst, thanks to the mandate to align Annex II of the Mercury Regulation with RoHS, this proposal therefore covers the three above-mentioned entries irrespective of Decision MC-4/3 paragraph 5 , th is d ecision remains relevant regarding the phase-out dates. Hence, this initiative proposes the most ambitious phase - out dates envisaged under paragraph 5 for these products and in doing so demonstrates the continuous ambition of the EU under Minamata, reflected by the formal proposal made by the Union ahead of COP4 26 and the relevant negotiating mandate 27 provided by the Member States to the Commission . Furthermore, t his p roposal also complements Decision MC-4/3 (paragraph 1) which added eight new MAPs to Annex A (Part I) to the Minamata Convention , includ ing CFL i for general lighting purposes that are ≤ 30 watts with a Hg content not exceeding 5 mg per lamp burner. These products will be prohibited from being manufactured, imported and exported as from 1 January 2026 . This is transposed into Annex II (Part A) to the Mercury Regulation by means of the concomitantly proposed Commission Delegated Regulation 28 . The use of a Delegated Act is justified as per Article 20 of the Mercury Regulation . Considering the above, objectives of this proposal are: (i) extend the prohibition to use dental amalgam to include all members of the population in the Union as from 1 January 2025 (total phase-out), whilst safeguarding the right of the dental practitioners to still use it when deemed strictly necessary for addressing specific medical needs of the patient (e.g., allergies, moisture control issues etc.) . (ii) set a prohibition on the manufactur ing in the Union and export of dental amalgam as from 1 January 2025. (iii) make the following six additional MAPs subject to a manufacturing, import and export prohibition by adding them to Annex II: · CFLs for general lighting purposes, not yet covered by Annex II nor by the concomitant amendment to Annex II resulting from above-cited Delegated Act; · Triband phosphor LFLs for general lighting purposes not yet covered by Annex II; · Halophosphate phosphor LFLs for general lighting purposes not yet covered by Annex II; · Non-linear triband phosphor lamps for general lighting purposes; · Non-linear halophosphate phosphor lamps; · HPS lamps for general lighting purposes. This proposal does not introduce an EU-wide obligation for Member States and operators to equip crematoria with mercury emissions abatement technology. While the Commission assessed the need for the Union to regulate the associated mercury emissions from crematoria in compliance with requirements set in Article 19 of the Regulation, the assessment concluded that the costs and administrative burdens would not be proportionate vis-à-vis the environmental objectives pursued and also unevenly spread across Member States (see also Section 3).
Revised version (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.
Article 11 Waste
Without prejudice to point (5) of Article 2 of this Regulation, mercury and mercury compounds, whether in pure form or in mixtures, from any of the following large sources shall be considered to be waste within the meaning of Directive 2008/98/EC and be disposed of without endangering human health or harming the environment, in accordance with that Directive: (a) the chlor-alkali industry; (b) the cleaning of natural gas; (c) non-ferrous mining and smelting operations; (d) extraction from cinnabar ore in the Union. Such disposal shall not lead to any form of reclamation of mercury.
Article 12 Reporting on large sources
2. The data referred to in points (a) and (b) of paragraph 1 shall be expressed using the codes laid down in Regulation (EC) No 2150/2002 of the European Parliament and of the Council ( 3 ). 3. The obligations laid down in paragraphs 1 and 2 shall cease to apply to an economic operator of chlor-alkali installations from one year after the date that all mercury cells operated by the economic operator have been decommissioned in accordance with Implementing Decision 2013/732/EU and all mercury has been handed over to waste management facilities.
Article 13 Storage of mercury waste
1. By way of derogation from point (a) of Article 5(3) of Directive 1999/31/EC, mercury waste may be temporarily stored in liquid form provided that the specific requirements for the temporary storage of mercury waste as laid down in Annexes I, II and III to that Directive are complied with and that such storage occurs in above-ground facilities dedicated to and equipped for the temporary storage of mercury waste. The derogation set out in the first subparagraph shall cease to apply as from 1 January 2026. 2. The Commission is empowered to adopt delegated acts in accordance with Article 21 in order to amend this Regulation by extending the period allowed for temporary storage of mercury waste referred to in paragraph 1 of this Article by up to three years. 3. Prior to being permanently disposed of, mercury waste shall undergo conversion and, where intended to be disposed of in above-ground facilities, conversion and solidification. Mercury waste that underwent conversion and, if applicable, solidification shall only be permanently disposed of in the following permanent storage facilities licensed for disposal of hazardous waste: (a) salt mines that are adapted for the permanent storage of mercury waste that underwent conversion, or deep underground hard rock formations providing a level of safety and confinement equivalent to or higher than that of such salt mines; or (b) above-ground facilities dedicated to and equipped for the permanent storage of mercury waste that underwent conversion and solidification and that provide a level of safety and confinement equivalent to or higher than that of the facilities referred to in point (a). Operators of permanent storage facilities shall ensure that mercury waste that underwent conversion and, if applicable, solidification is stored separately from other waste and in disposal batches in a storage chamber that is sealed. Those operators shall further ensure that the requirements set out in Directive 1999/31/EC, including the specific requirements for the temporary storage of mercury waste established in the third and fifth indents of Section 8 of Annex I and in Annex II to that Directive, are complied with in relation to the permanent storage facilities.
Article 14 Traceability
1. Operators of facilities undertaking the temporary storage of mercury waste shall, as soon as the mercury waste is taken out of temporary storage, issue a certificate confirming that the mercury waste was sent to a facility undertaking disposal operations covered by this Article. Once a certificate as referred to in the second subparagraph of this paragraph is issued, a copy thereof shall be transmitted without delay to the economic operators concerned referred to in Article 12. 2. Operators of facilities undertaking the conversion and, if applicable, the solidification of mercury waste shall, as soon as the conversion and, if applicable, the solidification operation of the entire shipment is completed, issue a certificate confirming that the entire shipment of mercury waste has been converted and, if applicable, solidified. Once a certificate as referred to in the second subparagraph of this paragraph is issued, a copy thereof shall be transmitted without delay to the operators of the facilities referred to in paragraph 1 of this Article and to the economic operators concerned referred to in Article 12. 3. Operators of facilities undertaking the permanent storage of mercury waste that underwent conversion and, if applicable, solidification shall, as soon as the disposal operation of the entire shipment is completed, issue a certificate confirming that the entire shipment of mercury waste that underwent conversion and, if applicable, solidification has been placed into permanent storage in compliance with Directive 1999/31/EC, including information on the storage location. Once a certificate as referred to in the first subparagraph of this paragraph is issued, a copy thereof shall be transmitted without delay to the operators of the facilities referred to in paragraphs 1 and 2 of this Article as well as to the economic operators concerned referred to in Article 12. 4. Each year by 31 January, the operators of the facilities referred to in paragraphs 1 and 2 shall transmit the register for the previous calendar year to the competent authorities of the Member States concerned. The competent authorities of the Member States concerned shall annually communicate each transmitted register to the Commission.
Article 15 Contaminated sites
1. The Commission shall organise an exchange of information with the Member States regarding the measures taken at national level to identify and assess sites contaminated by mercury and mercury compounds and to address the significant risks such contamination may pose to human health and the environment. 2. By 1 January 2021, the Commission shall make the information gathered pursuant to paragraph 1, including an inventory of sites contaminated by mercury and mercury compounds, publicly available on the internet.
Article 16 Penalties
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by the respective dates of application of the relevant provisions of this Regulation, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.
Article 17 Competent authorities
Member States shall designate the competent authorities responsible for carrying out obligations arising from this Regulation.
Article 18 Report
1. 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 ( 4 ), subject to the second subparagraph of Article 4(2) of that Directive. 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.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Mercury is a highly toxic element and a major risk to the environment and human health. It is a potent neurotoxin inducing permanent brain and kidney damage in adults and affecting foetal and early childhood development. Hence, mercury has been classified under Union law as being toxic for reproduction, fatal if inhaled, causing damage to all organs through prolonged or repeated exposure and very toxic for aquatic life with long lasting adverse effects 1 . Considering the risk posed by mercury to both human health and the environment, the Commission developed in 2005 a dedicated Mercury Strategy 2 as reviewed in 2010 3 inviting the Union to address all facets of mercury , including its use in products . As a result, t he Council of the European Union concluded as follows: ‘ Mercury-added products, where viable alternatives exist, should be phased out as rapidly and as completely as possible, with the ultimate goal that all mercury-added products should be phased-out, taking into due account technical and economic circumstanc es and the needs for scientific research and development .’ 4 The proposal also falls within a broader policy context by contributing to meeting the objectives of the European Green Deal 5 , the EU Chemicals Strategy for Sustainability 6 and the Zero Pollution Action Plan (hereafter; ‘ZPAP’) 7 adopted under it. In particular it aims to fulfil the Union’s commitment to lead by example and ensure that hazardous chemicals banned in the Union are not produced for export in accordance with Flagship 8 of the ZPAP on the minimis ation of the Union’s external pollution footprin t , including by amending relevant legislation. Furthermore, this initiative contributes to the development of a new Union framework for sustainable products 8 , as well as to the EU decarbonisation agenda 9 by promoting the substitution of mercury-containing lamps with more energy-efficient lighting alternatives such as light-emitting diode (LED) lamps. Regulation (EU) 2017/852 10 (hereinafter, ‘the Mercury Regulation ’) is the main instrument of Union law dedicated to mercury and mercury compounds (hereafter, ‘mercury’ or ‘Hg’) addressing the entire life-cycle of this substance from primary mercury mining to the final disposal of mercury waste and transpos ing the Minamata Convention on Mercury (hereafter, ‘Minamata Convention’ or ‘Convention’) 11 ratified by the Union in May 2017 12 and all the Member States . O ne key aspect addressed by t he Mercury Regulation concerns mercury use in products by establishing prohibitions on the manufacture, import and export of a range of mercury-added products (hereafter, ‘MAPs’) 13 , hence complement ing provisions established in other Union instruments setting restrictions on the placing on the market and import of MAPs . W ith a view to establishing a mercury-free Europe, t he p roposal addresses the last intentional remaining uses of mercury in products in the Union . According to t he review clause established in Article 19 14 of the Mercury Regulation , the Commission is asked to report to the European Parliament and to the Council on the outcome of its assessment regarding: (a) the feasibility of a total phase - out of the use of dental amalgam preferably by 2030 and the need for the EU to regulate associated mercury emissions from crematoria ; (b) the environmental benefits and the feasibility of prohibiting the manufacturing, import and export of other remaining M APs, which are already or will soon be banned from being placed on the market in accordance with other Union instruments. Paragraph 3 of Article 19 provides that the Commission shall, if appropriate, present a legislative proposal based on the above-mentioned assessment. The Commission adopted in August 2020 15 its Review R eport on the feasibility of phasing out the use of mercury in dental amalgam and other products . Both this report and the subsequent Commission’s impact assessment pointed to the appropriateness of presenting a legislative proposal to phas e out the use of dental amalgam and to restrict the manufacture and export of certain mercury-containing lamps. Dental amalgam is the largest remaining intentional use of mercury in the Union estimated at around 40 t in 2019. Article 10(2) of the Mercury Regulation already sets a partial ban on the use of dental amalgam by prohibiting it since 1 January 2018 for dental treatment of deciduous teeth and of vulnerable members of the population (i.e., children under the age of 15 and pregnant and breastfeeding women), except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient. In addition, under Article 10(3), Member States had to develop by 1 July 2019 a national plan on the phase-down on the use of dental amalgam. As regards other MAPs , Article 5 prohibits the manufacture, import and export of the MAPs listed in Annex II as from the phase-out dates specified therein (as from 31 December 2018 or 2020), except when they are deemed essential for civil protection and military uses or to those used for research, calibration of instruments or as a reference standard. The MAPs referred to in Annex II are products for which technically and economically feasible mercury-free alternatives are available. Annex II currently lists the following six types of MAPs: · batteries and accumulators, · certain switches and relays, · a range of mercury- containing lamps, including certain compact fluorescent lamps (CFLs) and linear fluorescent lamps (LFLs) for general lighting purposes, mercury-added cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFLs and EEFLs) for electronic displays and high-pressure mercury vapour lamps (HPMVs) for general lighting purposes, · cosmetics (except some eye products), · pesticides, biocides and topical antiseptics , · certain non-electronic measuring devices (e.g. , thermometers, barometers). At the time of the adoption of the Mercury Regulation ( May 2017 ) , the a bove-listed MAPs contained in Annex II were products that had already been prohibited from being placed on the market and imported in the Union in accordance with other Union instruments, including Directive (EC) 2006/66 on batteries 16 , Regulation (EC) 1907/2006 REACH 17 , Regulation (EC) 1223/2009 on cosmetic products 18 and Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (hereafter, ‘RoHS Directive’) 19 . However, considering the increasing availability of technically and economically feasible mercury-free alternatives, additional MAPs have in the meantime been subject to new restrictions on their placing on the market and import under the RoHS Directive. In this respect, the continued manufacture and export of those MAPs is a significant cause of mercury pollution, especially in third countries who often lack resources to ensure the environmental sound management of waste and where EU-made products therefore add to the national burden of hazardous products and increase the risk for local retailers, end-users, and inhabitants. In 2018, 13-38 t of mercury were exported from the Union in the form of dental amalgam as well as 0.5 t of mercury in lamps (equivalent to 156 million mercury-containing lamps) in 2020. Hence, the proposal aims to ensure coherence between the Mercury Regulation and the RoHS Directive and thereby contributing to the Union’s commitments under Flagship 8 of the Zero Pollution Action Plan by phasing out the manufacturing and export of the following mercury-containing lamps: – C urrent Annex II (Part A) ( entry 3) to the Mercury Regulation prohibits the manufacturing, import and export of the following CFLs for general lighting purposes : (i) CFL.i ≤ 30 watts with Hg content > 2,5 mg per lamp burner and (ii) CFL.ni 20 ≤ 30 watts with Hg content > 3,5 mg per lamp burner . A s a follow-up to the adoption of Commission Delegated Directive (EU) 2022/276 21 amending Annex III (entries 1, 1(a), 1(b), 1(c), 1(d) and 1(e) ) to the RoHS Directive, as from 24 February 2023, a ll CFLs for general lighting purposes can only be placed on the Union market and imported if they contain zero mercury content. – C urrent Annex II (Part A) ( entry 4 , point a) to the Mercury Regulation prohibits the manufacturing, import and export of t riband phosphor LFLs for general lighting purposes of < 60 W with Hg content > 5 mg per lamp burner . A s a follow-up to the adoption of Commission Delegated Directive (EU) 2022/284 22 amending Annex III (entries 2(a), 2(a)(1), 2(a)(2), 2(a)(3), 2(a)(4) and 2(a)(5)) to the RoHS Directive, as from 24 February 2023 or 24 August 2023, a ll triband phosphor LFLs for general lighting purposes can only be placed on the Union market and imported if they contain zero mercury content. – Whereas current Annex II to the Mercury Regulation does not cover non-linear triband phosphor fluorescent lamps , Commission Delegated Directive (EU) 2022/282 23 amending Annex III (entr y 2(b)(3) ) to the RoHS Directive only allows, as from 24 February 202 5 , the placing on the EU market and import of such lamps i f they contain zero mercury content. – C urrent Annex II (Part A) (entry 4 , point b) to the Mercury Regulation prohibits the manufacturing, import and export of h alophosphate phosphor (LFLs) of < 40 watts with Hg content > 10 mg per lamp burner . Annex III (entry 2(b)(1)) to the RoHS Directive only allows, as from 13 April 2012, the placing on the Union market and import of linear halophosphate phosphor lamps with tube diameter > 28 mm (e.g., T10 and T12) if they contain zero mercury content. – Whereas current Annex II to the Mercury Regulation does not cover non-linear halophosphate phosphor fluorescent lamps , Annex III (entry 2(b)(2)) to the RoHS Directive only allows, as from 13 April 2016, the placing on the EU market and import of non-linear halophosphate phosphor lamps if they contain zero mercury content. – Whereas c u rrent Annex II to the Mercury Regulation does not cover high pressure sodium (vapour) lamps (HPS) , Commission Delegated Directive (EU) 2022/283 24 amending Annex III (entries 4(b)(I), 4(b)(II) and 4(b)(III)) to the RoHS Directive only allows, as from 24 February 2023, the placing on the EU market and import of HPS with improved colour rendering index Ra > 60: P ≤ 155 W, > 60: 155 W < P ≤ 405 W or > 60: P > 405 W if they contain zero mercury content. In addition, not only does t he proposal aim at ensuring coherence within Union law on MAPs, but it also seeks to implement D ecision MC-4/3 of the Minamata Convention adopted by Parties at the fourth meeting of the Conferences of the Parties to that Convention in March 2022 (hereafter, ‘ COP4 ’) , amending, inter alia , Annex A (Part I) to the Convention on the list of other MAPs that are subject to a manufacture and international trade prohibition 25 . De facto , in aligning Annex II of the Mercury Regulation with RoHS, this proposal includes into that Regulation lamps covered by Decision MC-4/3 (paragraph 5) to be considered at COP5 (November 2023), thereby putting the Union in a leadership position for future international negotiations. This concerns the following lamps: · Halophosphate phosphor LFLs > 40 watts; · Halophosphate phosphor LFLs ≤ 40 watts with a Hg content not exceeding 10 mg per lamp; · Triband phosphor LFLs < 60 watts with a Hg content not exceeding 5 mg/lamp Whilst, thanks to the mandate to align Annex II of the Mercury Regulation with RoHS, this proposal therefore covers the three above-mentioned entries irrespective of Decision MC-4/3 paragraph 5 , th is d ecision remains relevant regarding the phase-out dates. Hence, this initiative proposes the most ambitious phase - out dates envisaged under paragraph 5 for these products and in doing so demonstrates the continuous ambition of the EU under Minamata, reflected by the formal proposal made by the Union ahead of COP4 26 and the relevant negotiating mandate 27 provided by the Member States to the Commission . Furthermore, t his p roposal also complements Decision MC-4/3 (paragraph 1) which added eight new MAPs to Annex A (Part I) to the Minamata Convention , includ ing CFL i for general lighting purposes that are ≤ 30 watts with a Hg content not exceeding 5 mg per lamp burner. These products will be prohibited from being manufactured, imported and exported as from 1 January 2026 . This is transposed into Annex II (Part A) to the Mercury Regulation by means of the concomitantly proposed Commission Delegated Regulation 28 . The use of a Delegated Act is justified as per Article 20 of the Mercury Regulation . Considering the above, objectives of this proposal are: (i) extend the prohibition to use dental amalgam to include all members of the population in the Union as from 1 January 2025 (total phase-out), whilst safeguarding the right of the dental practitioners to still use it when deemed strictly necessary for addressing specific medical needs of the patient (e.g., allergies, moisture control issues etc.) . (ii) set a prohibition on the manufactur ing in the Union and export of dental amalgam as from 1 January 2025. (iii) make the following six additional MAPs subject to a manufacturing, import and export prohibition by adding them to Annex II: · CFLs for general lighting purposes, not yet covered by Annex II nor by the concomitant amendment to Annex II resulting from above-cited Delegated Act; · Triband phosphor LFLs for general lighting purposes not yet covered by Annex II; · Halophosphate phosphor LFLs for general lighting purposes not yet covered by Annex II; · Non-linear triband phosphor lamps for general lighting purposes; · Non-linear halophosphate phosphor lamps; · HPS lamps for general lighting purposes. This proposal does not introduce an EU-wide obligation for Member States and operators to equip crematoria with mercury emissions abatement technology. While the Commission assessed the need for the Union to regulate the associated mercury emissions from crematoria in compliance with requirements set in Article 19 of the Regulation, the assessment concluded that the costs and administrative burdens would not be proportionate vis-à-vis the environmental objectives pursued and also unevenly spread across Member States (see also Section 3).
Revised version (Article 18 Report):
1. 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 ( 4 ), 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.
Article 19 Review
2. By 31 December 2024, 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. 3. The Commission shall, if appropriate, present a legislative proposal together with its reports referred to in paragraphs 1 and 2.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Mercury is a highly toxic element and a major risk to the environment and human health. It is a potent neurotoxin inducing permanent brain and kidney damage in adults and affecting foetal and early childhood development. Hence, mercury has been classified under Union law as being toxic for reproduction, fatal if inhaled, causing damage to all organs through prolonged or repeated exposure and very toxic for aquatic life with long lasting adverse effects 1 . Considering the risk posed by mercury to both human health and the environment, the Commission developed in 2005 a dedicated Mercury Strategy 2 as reviewed in 2010 3 inviting the Union to address all facets of mercury , including its use in products . As a result, t he Council of the European Union concluded as follows: ‘ Mercury-added products, where viable alternatives exist, should be phased out as rapidly and as completely as possible, with the ultimate goal that all mercury-added products should be phased-out, taking into due account technical and economic circumstanc es and the needs for scientific research and development .’ 4 The proposal also falls within a broader policy context by contributing to meeting the objectives of the European Green Deal 5 , the EU Chemicals Strategy for Sustainability 6 and the Zero Pollution Action Plan (hereafter; ‘ZPAP’) 7 adopted under it. In particular it aims to fulfil the Union’s commitment to lead by example and ensure that hazardous chemicals banned in the Union are not produced for export in accordance with Flagship 8 of the ZPAP on the minimis ation of the Union’s external pollution footprin t , including by amending relevant legislation. Furthermore, this initiative contributes to the development of a new Union framework for sustainable products 8 , as well as to the EU decarbonisation agenda 9 by promoting the substitution of mercury-containing lamps with more energy-efficient lighting alternatives such as light-emitting diode (LED) lamps. Regulation (EU) 2017/852 10 (hereinafter, ‘the Mercury Regulation ’) is the main instrument of Union law dedicated to mercury and mercury compounds (hereafter, ‘mercury’ or ‘Hg’) addressing the entire life-cycle of this substance from primary mercury mining to the final disposal of mercury waste and transpos ing the Minamata Convention on Mercury (hereafter, ‘Minamata Convention’ or ‘Convention’) 11 ratified by the Union in May 2017 12 and all the Member States . O ne key aspect addressed by t he Mercury Regulation concerns mercury use in products by establishing prohibitions on the manufacture, import and export of a range of mercury-added products (hereafter, ‘MAPs’) 13 , hence complement ing provisions established in other Union instruments setting restrictions on the placing on the market and import of MAPs . W ith a view to establishing a mercury-free Europe, t he p roposal addresses the last intentional remaining uses of mercury in products in the Union . According to t he review clause established in Article 19 14 of the Mercury Regulation , the Commission is asked to report to the European Parliament and to the Council on the outcome of its assessment regarding: (a) the feasibility of a total phase - out of the use of dental amalgam preferably by 2030 and the need for the EU to regulate associated mercury emissions from crematoria ; (b) the environmental benefits and the feasibility of prohibiting the manufacturing, import and export of other remaining M APs, which are already or will soon be banned from being placed on the market in accordance with other Union instruments. Paragraph 3 of Article 19 provides that the Commission shall, if appropriate, present a legislative proposal based on the above-mentioned assessment. The Commission adopted in August 2020 15 its Review R eport on the feasibility of phasing out the use of mercury in dental amalgam and other products . Both this report and the subsequent Commission’s impact assessment pointed to the appropriateness of presenting a legislative proposal to phas e out the use of dental amalgam and to restrict the manufacture and export of certain mercury-containing lamps. Dental amalgam is the largest remaining intentional use of mercury in the Union estimated at around 40 t in 2019. Article 10(2) of the Mercury Regulation already sets a partial ban on the use of dental amalgam by prohibiting it since 1 January 2018 for dental treatment of deciduous teeth and of vulnerable members of the population (i.e., children under the age of 15 and pregnant and breastfeeding women), except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient. In addition, under Article 10(3), Member States had to develop by 1 July 2019 a national plan on the phase-down on the use of dental amalgam. As regards other MAPs , Article 5 prohibits the manufacture, import and export of the MAPs listed in Annex II as from the phase-out dates specified therein (as from 31 December 2018 or 2020), except when they are deemed essential for civil protection and military uses or to those used for research, calibration of instruments or as a reference standard. The MAPs referred to in Annex II are products for which technically and economically feasible mercury-free alternatives are available. Annex II currently lists the following six types of MAPs: · batteries and accumulators, · certain switches and relays, · a range of mercury- containing lamps, including certain compact fluorescent lamps (CFLs) and linear fluorescent lamps (LFLs) for general lighting purposes, mercury-added cold cathode fluorescent lamps and external electrode fluorescent lamps (CCFLs and EEFLs) for electronic displays and high-pressure mercury vapour lamps (HPMVs) for general lighting purposes, · cosmetics (except some eye products), · pesticides, biocides and topical antiseptics , · certain non-electronic measuring devices (e.g. , thermometers, barometers). At the time of the adoption of the Mercury Regulation ( May 2017 ) , the a bove-listed MAPs contained in Annex II were products that had already been prohibited from being placed on the market and imported in the Union in accordance with other Union instruments, including Directive (EC) 2006/66 on batteries 16 , Regulation (EC) 1907/2006 REACH 17 , Regulation (EC) 1223/2009 on cosmetic products 18 and Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (hereafter, ‘RoHS Directive’) 19 . However, considering the increasing availability of technically and economically feasible mercury-free alternatives, additional MAPs have in the meantime been subject to new restrictions on their placing on the market and import under the RoHS Directive. In this respect, the continued manufacture and export of those MAPs is a significant cause of mercury pollution, especially in third countries who often lack resources to ensure the environmental sound management of waste and where EU-made products therefore add to the national burden of hazardous products and increase the risk for local retailers, end-users, and inhabitants. In 2018, 13-38 t of mercury were exported from the Union in the form of dental amalgam as well as 0.5 t of mercury in lamps (equivalent to 156 million mercury-containing lamps) in 2020. Hence, the proposal aims to ensure coherence between the Mercury Regulation and the RoHS Directive and thereby contributing to the Union’s commitments under Flagship 8 of the Zero Pollution Action Plan by phasing out the manufacturing and export of the following mercury-containing lamps: – C urrent Annex II (Part A) ( entry 3) to the Mercury Regulation prohibits the manufacturing, import and export of the following CFLs for general lighting purposes : (i) CFL.i ≤ 30 watts with Hg content > 2,5 mg per lamp burner and (ii) CFL.ni 20 ≤ 30 watts with Hg content > 3,5 mg per lamp burner . A s a follow-up to the adoption of Commission Delegated Directive (EU) 2022/276 21 amending Annex III (entries 1, 1(a), 1(b), 1(c), 1(d) and 1(e) ) to the RoHS Directive, as from 24 February 2023, a ll CFLs for general lighting purposes can only be placed on the Union market and imported if they contain zero mercury content. – C urrent Annex II (Part A) ( entry 4 , point a) to the Mercury Regulation prohibits the manufacturing, import and export of t riband phosphor LFLs for general lighting purposes of < 60 W with Hg content > 5 mg per lamp burner . A s a follow-up to the adoption of Commission Delegated Directive (EU) 2022/284 22 amending Annex III (entries 2(a), 2(a)(1), 2(a)(2), 2(a)(3), 2(a)(4) and 2(a)(5)) to the RoHS Directive, as from 24 February 2023 or 24 August 2023, a ll triband phosphor LFLs for general lighting purposes can only be placed on the Union market and imported if they contain zero mercury content. – Whereas current Annex II to the Mercury Regulation does not cover non-linear triband phosphor fluorescent lamps , Commission Delegated Directive (EU) 2022/282 23 amending Annex III (entr y 2(b)(3) ) to the RoHS Directive only allows, as from 24 February 202 5 , the placing on the EU market and import of such lamps i f they contain zero mercury content. – C urrent Annex II (Part A) (entry 4 , point b) to the Mercury Regulation prohibits the manufacturing, import and export of h alophosphate phosphor (LFLs) of < 40 watts with Hg content > 10 mg per lamp burner . Annex III (entry 2(b)(1)) to the RoHS Directive only allows, as from 13 April 2012, the placing on the Union market and import of linear halophosphate phosphor lamps with tube diameter > 28 mm (e.g., T10 and T12) if they contain zero mercury content. – Whereas current Annex II to the Mercury Regulation does not cover non-linear halophosphate phosphor fluorescent lamps , Annex III (entry 2(b)(2)) to the RoHS Directive only allows, as from 13 April 2016, the placing on the EU market and import of non-linear halophosphate phosphor lamps if they contain zero mercury content. – Whereas c u rrent Annex II to the Mercury Regulation does not cover high pressure sodium (vapour) lamps (HPS) , Commission Delegated Directive (EU) 2022/283 24 amending Annex III (entries 4(b)(I), 4(b)(II) and 4(b)(III)) to the RoHS Directive only allows, as from 24 February 2023, the placing on the EU market and import of HPS with improved colour rendering index Ra > 60: P ≤ 155 W, > 60: 155 W < P ≤ 405 W or > 60: P > 405 W if they contain zero mercury content. In addition, not only does t he proposal aim at ensuring coherence within Union law on MAPs, but it also seeks to implement D ecision MC-4/3 of the Minamata Convention adopted by Parties at the fourth meeting of the Conferences of the Parties to that Convention in March 2022 (hereafter, ‘ COP4 ’) , amending, inter alia , Annex A (Part I) to the Convention on the list of other MAPs that are subject to a manufacture and international trade prohibition 25 . De facto , in aligning Annex II of the Mercury Regulation with RoHS, this proposal includes into that Regulation lamps covered by Decision MC-4/3 (paragraph 5) to be considered at COP5 (November 2023), thereby putting the Union in a leadership position for future international negotiations. This concerns the following lamps: · Halophosphate phosphor LFLs > 40 watts; · Halophosphate phosphor LFLs ≤ 40 watts with a Hg content not exceeding 10 mg per lamp; · Triband phosphor LFLs < 60 watts with a Hg content not exceeding 5 mg/lamp Whilst, thanks to the mandate to align Annex II of the Mercury Regulation with RoHS, this proposal therefore covers the three above-mentioned entries irrespective of Decision MC-4/3 paragraph 5 , th is d ecision remains relevant regarding the phase-out dates. Hence, this initiative proposes the most ambitious phase - out dates envisaged under paragraph 5 for these products and in doing so demonstrates the continuous ambition of the EU under Minamata, reflected by the formal proposal made by the Union ahead of COP4 26 and the relevant negotiating mandate 27 provided by the Member States to the Commission . Furthermore, t his p roposal also complements Decision MC-4/3 (paragraph 1) which added eight new MAPs to Annex A (Part I) to the Minamata Convention , includ ing CFL i for general lighting purposes that are ≤ 30 watts with a Hg content not exceeding 5 mg per lamp burner. These products will be prohibited from being manufactured, imported and exported as from 1 January 2026 . This is transposed into Annex II (Part A) to the Mercury Regulation by means of the concomitantly proposed Commission Delegated Regulation 28 . The use of a Delegated Act is justified as per Article 20 of the Mercury Regulation . Considering the above, objectives of this proposal are: (i) extend the prohibition to use dental amalgam to include all members of the population in the Union as from 1 January 2025 (total phase-out), whilst safeguarding the right of the dental practitioners to still use it when deemed strictly necessary for addressing specific medical needs of the patient (e.g., allergies, moisture control issues etc.) . (ii) set a prohibition on the manufactur ing in the Union and export of dental amalgam as from 1 January 2025. (iii) make the following six additional MAPs subject to a manufacturing, import and export prohibition by adding them to Annex II: · CFLs for general lighting purposes, not yet covered by Annex II nor by the concomitant amendment to Annex II resulting from above-cited Delegated Act; · Triband phosphor LFLs for general lighting purposes not yet covered by Annex II; · Halophosphate phosphor LFLs for general lighting purposes not yet covered by Annex II; · Non-linear triband phosphor lamps for general lighting purposes; · Non-linear halophosphate phosphor lamps; · HPS lamps for general lighting purposes. This proposal does not introduce an EU-wide obligation for Member States and operators to equip crematoria with mercury emissions abatement technology. While the Commission assessed the need for the Union to regulate the associated mercury emissions from crematoria in compliance with requirements set in Article 19 of the Regulation, the assessment concluded that the costs and administrative burdens would not be proportionate vis-à-vis the environmental objectives pursued and also unevenly spread across Member States (see also Section 3).
Revised version (Article 19 Review):
2. By 31 December 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. 3. The Commission shall, if appropriate, present a legislative proposal together with the reports referred to in this Article.
Article 20 Amendment of Annexes
The Commission is empowered to adopt delegated acts in accordance with Article 21 of this Regulation in order to amend its Annexes I, II, III and IV to align them with decisions adopted by the Conference of the Parties to the Convention in accordance with Article 27 of the Convention, provided that the Union has supported the decision concerned by means of a Council decision adopted in accordance with Article 218(9) TFEU.
Article 21 Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 13(2) and Article 20 shall be conferred on the Commission for a period of five years from 13 June 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 13(2) and Article 20 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 13(2) and Article 20 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 22 Committee procedure
1. For the adoption of forms for import and export under Article 6, of technical requirements for environmentally sound interim storage of mercury, mercury compounds or mixtures of mercury under Article 7(3), of a decision under Article 8(6), and of questionnaires under Article 18(2), the Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 23 Repeal
Regulation (EC) No 1102/2008 is repealed with effect from 1 January 2018. References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex V.
Article 24 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 1 January 2018. However, point (d) of Part I of Annex III shall apply from 11 December 2017.