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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)
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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.
For the purposes of this Regulation, the following definitions apply:
‘mercury’ means metallic mercury (Hg, CAS RN 7439-97-6);
‘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;
‘mixture’ means a mixture or solution composed of two or more substances;
‘mercury-added product’ means a product or product component that contains mercury or a mercury compound that was intentionally added;
‘mercury waste’ means metallic mercury that qualifies as waste as defined in point (1) of Article 3 of Directive 2008/98/EC;
‘export’ means any of the following:
the permanent or temporary export of mercury, mercury compounds, mixtures of mercury and mercury-added products meeting the conditions of Article 28(2) TFEU;
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;
‘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;
‘disposal’ means disposal as defined in point (19) of Article 3 of Directive 2008/98/EC;
‘primary mercury mining’ means mining in which the principal material sought is mercury;
‘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;
‘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.
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.
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:
(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.
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.
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.
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).
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.
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.
3.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.
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.
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.
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.
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:
the chlor-alkali industry;
the cleaning of natural gas;
non-ferrous mining and smelting operations;
extraction from cinnabar ore in the Union.
Such disposal shall not lead to any form of reclamation of mercury.
1.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).
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.
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 2023.
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.
1.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:
the origin and amount of that waste;
the name and contact details of the supplier and the owner of that waste;
(b)for each shipment of mercury waste leaving the facility:
the amount of that waste and its mercury content;
the destination and intended disposal operation of that waste;
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;
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.
2.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:
the origin and amount of that waste;
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:
the amount of that waste and its mercury content;
the destination and intended disposal operation of that waste;
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.
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.
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.
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.
Member States shall designate the competent authorities responsible for carrying out obligations arising from this Regulation.
1.By 1 January 2020 and at appropriate intervals thereafter, Member States shall prepare, provide to the Commission and make publicly available on the internet a report with the following:
(a)information concerning the implementation of this Regulation;
(b)information needed for the fulfilment by the Union of its reporting obligation under Article 21 of the Convention;
(c)a summary of the information gathered in accordance with Article 12 of this Regulation;
(d)information regarding mercury located in their territories:
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;
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.
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.
1.By 30 June 2020, the Commission shall report to the European Parliament and to the Council on the outcome of its assessment regarding:
(a)the need for the Union to regulate emissions of mercury and mercury compounds from crematoria;
(b)the feasibility of a phase out of the use of dental amalgam in the long term, and preferably by 2030, taking into account the national plans referred to in Article 10(3) and whilst fully respecting Member States' competence for the organisation and delivery of health services and medical care; and
(c)the environmental benefits and the feasibility of a further alignment of Annex II with relevant Union legislation regulating the placing on the market of mercury-added products.
2.By 31 December 2024, 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.
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.
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.
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.
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.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 17 May 2017.
For the European Parliament
The President
A. Tajani
For the Council
The President
C. Abela
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