Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (Text with EEA relevance. )

CHAPTER I

GENERAL PROVISIONS

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;

(6) ‘export’ means any of the following: (a) the permanent or temporary export of mercury, mercury compounds, mixtures of mercury and mercury-added products meeting the conditions of Article 28(2) TFEU; (b) the re-export of mercury, mercury compounds, mixtures of mercury and mercury-added products not meeting the conditions of Article 28(2) TFEU which are placed under a customs procedure other than the external Union transit procedure for movement of goods through the customs territory of the Union;

(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.

CHAPTER II

TRADE AND MANUFACTURING RESTRICTIONS CONCERNING MERCURY, MERCURY COMPOUNDS, MIXTURES OF MERCURY AND MERCURY-ADDED PRODUCTS

Article 3

Export restrictions

Article 4

Import restrictions

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:

(a) the exporting country is a Party to the Convention and the exported mercury is not from primary mercury mining that is prohibited under Article 3(3) and (4) of the Convention; or

(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.

Article 5

Export, import and manufacturing of mercury-added products

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).

CHAPTER III

RESTRICTIONS ON USE AND STORAGE OF MERCURY, MERCURY COMPOUNDS AND MIXTURES OF MERCURY

Article 7

Industrial activities

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

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.

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.

Where an economic operator intends to apply for a decision pursuant to paragraph 6 in order to manufacture or place on the market a new mercury-added product, or to use a new manufacturing process, that would provide significant environmental or health benefits and pose no significant risks either to the environment or to human health, and where no technically practicable mercury-free alternatives providing such benefits are available, that economic operator shall notify the competent authorities of the Member State concerned. That notification shall include the following information:

(a) a technical description of the product or process concerned;

(b) an assessment of its environmental and health benefits and risks;

(c) evidence demonstrating the absence of technically practicable mercury-free alternatives providing significant environmental or health benefits;

(d) a detailed explanation of the manner in which the process is to be operated or the product is to be manufactured, used and disposed of as waste after use, in order to ensure a high level of protection of the environment and of human health.

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.

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).

Article 9

Artisanal and small-scale gold mining and processing

Article 10

Dental amalgam

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.

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.

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.

Dental practitioners shall not release directly or indirectly such amalgam waste into the environment under any circumstances.

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.

CHAPTER IV

DISPOSAL OF WASTE AND MERCURY WASTE

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

Economic operators within the industry sectors referred to in points (a), (b) and (c) of Article 11 shall send, each year by 31 May, the following to the competent authorities of the Member States concerned:

(a) data on the total amount of mercury waste stored in each of their installations;

(b) data on the total amount of mercury waste sent to individual facilities undertaking the temporary storage, the conversion and, if applicable, solidification of mercury waste, or the permanent storage of mercury waste that underwent conversion and, if applicable, solidification;

(c) the location and contact details of each facility referred to in point (b);

(d) a copy of the certificate provided by the operator of the facility undertaking the temporary storage of mercury waste, in accordance with Article 14(1);

(e) a copy of the certificate provided by the operator of the facility undertaking the conversion and, if applicable, the solidification of mercury waste, in accordance with Article 14(2);

(f) a copy of the certificate provided by the operator of the facility undertaking the permanent storage of mercury waste that underwent conversion and, if applicable, solidification, in accordance with Article 14(3).

Article 13

Storage of mercury waste

The derogation set out in the first subparagraph shall cease to apply as from 1 January 2026.

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

Operators of facilities undertaking the temporary storage of mercury waste shall establish a register including the following:

(a) for each shipment of mercury waste received: (i) the origin and amount of that waste; (ii) the name and contact details of the supplier and the owner of that waste;

(b) for each shipment of mercury waste leaving the facility: (i) the amount of that waste and its mercury content; (ii) the destination and intended disposal operation of that waste; (iii) a copy of the certificate provided by the operator of the facility undertaking the conversion and, if applicable, the solidification of that waste, as referred to in paragraph 2; (iv) a copy of the certificate provided by the operator of the facility undertaking the permanent storage of the mercury waste that underwent conversion and, if applicable, solidification, as referred to in paragraph 3;

(c) the amount of mercury waste stored at the facility at the end of each month.

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.

Operators of facilities undertaking the conversion and, if applicable, the solidification of mercury waste shall establish a register including the following:

(a) for each shipment of mercury waste received: (i) the origin and amount of that waste; (ii) the name and contact details of the supplier and the owner of that waste;

(b) for each shipment of mercury waste that underwent conversion and, if applicable, solidification leaving the facility: (i) the amount of that waste and its mercury content; (ii) the destination and intended disposal operation of that waste; (iii) a copy of the certificate provided by the operator of the facility undertaking the permanent storage of that waste, as referred to in paragraph 3;

(c) the amount of mercury waste stored at the facility at the end of each month.

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.

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.

Article 15

Contaminated sites

CHAPTER V

PENALTIES, COMPETENT AUTHORITIES AND REPORTING

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

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;

(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 (⁴), subject to the second subparagraph of Article 4(2) of that Directive.