Explanatory Memorandum to COM(2016)39 - Regulation on mercury, and repealing Regulation (EC) No 1102/2008 - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2016)39 - Regulation on mercury, and repealing Regulation (EC) No 1102/2008. |
|---|---|
| source | COM(2016)39  |
| date | 02-02-2016 |
1. CONTEXT OF THE PROPOSAL
General context – Grounds for and objectives of the proposal
The Union and twenty-six Member States signed a new International Convention on Mercury 1 , negotiated under the auspices of UNEP. The Convention is named the 'Minamata Convention' (hereafter, 'Minamata Convention' or 'the Convention'), after the name of the town where the worst ever case of mercury pollution occurred between 1950 and 1960. The signature marked the successful end of a negotiation process, involving five sessions of an Intergovernmental Negotiating Committee. All Member States are committed to ratifying the Convention.
The Convention addresses the whole life-cycle of mercury, from primary mercury mining to the management of mercury waste, with the objective to protect human health and the environment from anthropogenic emissions of mercury and mercury compounds to air, water and land. In particular, it sets restrictions on primary mining of mercury and on international trade of mercury, prohibits the manufacture, import and export of a wide range of mercury-added products, foresees prohibitions or operating conditions for several manufacturing processes using mercury, calls for discouraging new uses of mercury in products and industrial processes and measures to be taken to reduce mercury emissions from artisanal and small-scale gold mining (hereafter, 'ASGM') and industrial activities, including through the use of best available techniques and requires interim storage of mercury and management of mercury waste to occur in an environmentally sound manner.
Much of the Minamata Convention is already covered by Union legislation. Regulation (EC) No 1102/2008 2 sets an export prohibition on mercury and on several mercury compounds, qualifies mercury from certain sources as waste and establishes rules on the storage of mercury. Other EU instruments contain ad hoc provisions on mercury and mercury compounds, including Regulation (EU) No 649/2012 3 that sets a notification system applicable inter alia, to imports of mercury and Regulations (EC) 396/2005 4 , 1907/2006 5 , 1223/2009 6 and Directives 2006/66/EC 7 and 2011/65/EU 8 , which address the placing on the Union market of a range of mercury-added products and set maximum levels of mercury content. Additionally, Directives 2010/75/EU 9 , 2012/18/EU 10 , 2008/98/EC 11 and 1999/31/EC 12 aim at controlling, reducing and, when mercury-free alternatives exist, eliminating point sources and diffuse emissions of mercury, mercury compounds and mercury waste into the environment.
The assessment of the Union acquis has identified a limited number of regulatory gaps that need to be filled in to ensure the full alignment of Union legislation with the Convention. 13 This proposal seeks to address those gaps, which concern the following issues:
• the import of mercury;
• the export of certain mercury-added products;
• the use of mercury in certain manufacturing processes;
• new mercury uses in products and manufacturing processes;
• mercury use in ASGM and
• mercury use in dental amalgam.
In the interest of legal clarity, the obligations resulting from the Convention that are not yet transposed into EU law should be integrated into a single legal act.
For that purpose, Regulation (EC) No 1102/2008, as the only dedicated Union legal act on mercury to date, should serve as the basis for doing so. Yet, given the nature and extent of the necessary modifications to Regulation (EC) No 1102/2008 and the need to enhance consistency and legal clarity, this proposal should repeal and replace it while taking over its substantive obligations whenever still needed.
Contents
This initiative is consistent with the seventh Environment Action Programme 14 that establishes the long-term objective of a non-toxic environment and that stipulates, for that purpose, that action is needed to ensure the minimisation of significant adverse effects of chemicals on human health and the environment by 2020.
The objectives of this initiative are also consistent with the Europe 2020 objectives on smart, inclusive, and sustainable growth, by stimulating innovation in terms of the development of mercury-free products and manufacturing processes. This proposal, by promoting ratifications of the Convention and its entry into force, will contribute to levelling the global playing-field for industrial processes using or unintentionally emitting mercury and mercury compounds and the manufacturing and trading of mercury-added products, thereby promoting the competitiveness of Union industry, all the more as most its provisions mirror the Union acquis.
Additionally, simplification and clarification of the acquis to enable better implementation is pursued where possible.
2. RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
Member State authorities and stakeholders were consulted within the framework of two studies conducted by the Commission 15 , 16 and at a workshop held in Brussels on 7 July 2014 following which a request for additional information on specific issues was also published 17 . All written contributions received were made publicly available on the Commission's website 18 . A broad on-line public consultation was also run from 14 August 2014 until 14 November 2014 and publicised on the basis of a questionnaire 19 on the 'Your voice in Europe' webpage 20 . The objective of this survey was to get a better understanding of the views of the public stakeholders and Member States concerning the ratification of the Convention and specific issues related to its transposition and implementation, in particular in relation to the areas where Union legislation needs to be aligned with the Convention. The target groups were citizens, public authorities, research organisations, academia, non-profit/non-governmental organisations, consultancies and private companies and their representative organisations. There was broad consensus among stakeholders and the public in general that the Union should ratify the Minamata Convention. Specific issues raised by stakeholders were taken into account in the preparation of this proposal.
The impact assessment (hereafter: 'IA') concluded that the ratification and implementation of the Minamata Convention will provide the EU with significant environmental and human health benefits, mainly due to the expected reduction of mercury emissions originating in other parts of the world. In particular:
• Once implemented, important provisions of the Convention concerning among others the application of the best available techniques (hereafter, 'BAT') to abate emissions from large industrial plants, the phase out of existing primary mining combined with the prohibition of new primary mining or the establishment of restrictions on ASGM are expected to have a great positive environmental impact both globally and for the Union. Such activities practically do not exist within the EU or are already regulated. This will allow the Union to meet its objectives on the protection of the environment and human health, as outlined in the 2005 Community Strategy Concerning Mercury ('the Strategy') 21 .
• By implementing the Convention, third countries will apply similar standards as those currently in force within the Union to many industrial activities. This will help address potential competitive advantages benefitting companies in non-EU Member States that are subject to less strict (or even non-existing) environmental standards and possibly open new markets for Union companies specialising in environmental technology. As an illustrative example, the provisions of the Convention on mercury emissions from certain industrial activities will make numerous industrial facilities emitting mercury on the global scale subject to the use of BAT that are already applied by the Union industry.
• The IA examined different policy options to address the above-listed six regulatory gaps affecting EU law: a baseline option corresponding to “No EU action”, and at least two different options for each of the relevant policy areas, i.e. one option consisting in transposing the obligations set out in the Convention and one option consisting in laying down requirements going beyond what is required by the Convention.
With regard to the use of dental amalgam, the IA assessed the need for measures and their potential impacts:
• Commission Decision 2000/532/EC 22 characterises amalgam waste from dental care as hazardous waste, it is therefore subject to the provisions of the Waste Framework Directive 23 . Mercury emissions from dental cabinets are also subject to Union water legislation. Mercury is classified as priority hazardous substance according to Annex X of the Water Framework Directive 24 and hence the release of this substance to water has to be drastically reduced. As amalgam is the second biggest use of mercury within the Union with an estimated pollution potential of about 75t of mercury per year and a long-term pollution potential of more than 1000t 25 , specific measures addressing this source are necessary.
• The IA concludes, in the light of the available scientific information, that a prohibition of the use of dental amalgam would not be proportionate as the health risks of dental amalgam are not clearly demonstrated and the cost of a prohibition would be high. Furthermore, the assessment shows that two measures included in the list of measures proposed in the Convention, and from which Parties should take at least two, would deliver environmental and health benefits at a low cost, i.e. the restriction of the use of dental amalgam to its encapsulated form and the promotion of the use of best environmental practices in dental facilities. Such measures are in line with Action 4 of the Mercury Strategy that was confirmed as a priority area for further action by the review of the Strategy in 2010. They would reduce exposure of dentists and patients to mercury emissions and ensure a drastic reduction of mercury releases to sewage systems and to the environment via urban wastewater treatment plants. Furthermore, the generation of new jobs is expected in companies involved in the manufacturing, installation and maintenance of amalgam separators and in companies specialising in the collection and treatment of mercury-containing waste.
• Although the majority of the businesses concerned would qualify as microenterprises, they would not be disproportionally affected by the proposed measures as (1) given the type of activity they would not suffer from competition with larger undertakings, (2) the implementation cost of the measure is limited and would require only low investment, and (3) no jobs loss is expected in the dentistry sector. Furthermore, those measures are good practice promoted 26 by the Council of European Dentists and the majority have already implemented them. However, as such undertakings would need time to adapt to the obligations set out in this Regulation, the compliance date proposed for these measures is one year later than for the other measures covered in this Regulation. Finally, the requirement to use amalgam in an encapsulated form would not cause any additional burden to dentists who have opted out from using dental amalgam.
With regard to the other gaps, the analysis carried out in the IA concludes as follows:
• Import restrictions on mercury: trade restrictions that would go beyond the requirements of the Convention, i.e. to set an unconditional mercury import prohibition (rather than allowing imports of mercury under certain conditions related to the place of origin and to the source of the imported mercury) would not be justified as they would be more costly for Union industry and would not have any significant environmental benefits.
• Export restrictions on certain mercury-added products: trade restrictions that would go beyond the ones established in the Convention, i.e. to prohibit the export of mercury-added products subject to stricter Union rules regarding their mercury content than those laid down in the Convention (rather than prohibiting only exports of mercury-added products that do not meet the requirements of the Convention) would not be justified given that mercury input and releases into the environment would remain largely unchanged and that mercury emissions could, as a consequence of such a prohibition, increase in third countries.
• To restrict the use of mercury in certain manufacturing processes: the establishment of an absolute prohibition on the use of mercury for the production of sodium or potassium ethylate or methylate (instead of requirements limiting mercury use and emissions as foreseen in the Convention) would not be justified given the need for industry to be supplied with certain chemicals for which the availability of mercury-free production processes could not be demonstrated.
• To restrict mercury use in new manufacturing processes and products: the Convention provides only for Parties to take measures to discourage the development of new manufacturing processes using mercury and the production and placing on the market of new mercury-added products. Setting up a conditional prohibition applicable to those processes and products would result in the best environmental and economic outcome as it would have a strong signal value and thus reduce the risk that economic operators engage in costly development of such products or processes that would likely be subsequently prohibited.
• To restrict mercury use in ASGM: as the only Member State concerned, France, has already taken measures to prohibit the use of mercury in ASGM, it is therefore sufficient for the Union to simply transpose the obligation to develop and review a national action plan in accordance with the Convention.
Economically-wise, the total cost of above-mentioned options, that have been singled out in the IA as the preferred ones ranges between 13-135 million EUR/y, mainly reflecting the costs of measures relating to the use of mercury in manufacturing processes and dental amalgam.
3. LEGAL ELEMENTS OF THE PROPOSAL
While Regulation (EC) No 1102/2008 constitutes the starting point for this Proposal, it is appropriate to repeal and replace it for the sake of legal clarity. Annex IV contains the correlation table.
Articles 1 and 2 specify the subject-matter of the proposal and provide definitions of key terms used therein.
Article 3 read in combination with Annex I sets a prohibition on the export from the Union of mercury, of several mercury compounds and of mixtures of mercury with other substances, save in respect of those mercury compounds that can still be exported when aimed at laboratory-scale research. This prohibition is already established since March 2011 in accordance with Article 1 of Regulation (EC) No 1102/2008 and complements the one provided for in Regulation (EU) No 649/2012. It transposes Article 3 (6), of the Minamata Convention read in combination with its Article 3 (1) ((a) and (b)), and (2) (a).
Article 4 prohibits the import into the Union of mercury when intended for ASGM and puts up a conditional prohibition on the import into the Union of mercury and of mixtures when planned for other uses. Such a prohibition does not apply to imports of mercury and of mixtures for final disposal as waste, to imports of mercury from countries that are Parties to the Minamata Convention when it originates from a primary mining source that is still allowed under Article 3 i of the Convention, to imports of mercury from countries that are not Parties to the Convention provided that imported mercury is neither from primary mining nor from the chlor-alkali sector and that an import written consent has been granted. For the purpose of streamlining administrative activity and preventing an increased administrative burden, Article 4(3) specifies that the national competent authorities designated under Regulation (EU) No 649/2012 shall also be those in charge of the implementation and control of such a prohibition.
Article 5 read in combination with Annex II transposes Article 4(1) and Annex A (Part I) of the Minamata Convention. It sets a prohibition, which shall start on 1st January 2021, on the export, import and manufacturing of a range of mercury-added products. Article 5 applies both as a complement and without prejudice to provisions of the EU acquis that establish already restrictions on the placing on the market and that set stricter requirements in terms, for instance, of the maximum mercury content of these products, as laid down, among others, in Directive 2006/66/EC.
Article 6 foresees the possible adoption of Commission Implementing Decisions specifying the trade forms to be used by the Member States' competent authorities to implement Articles 3 and 4, as a follow up of Decisions that will be adopted by the Conference of the parties of the Minamata Convention ('CoP') in accordance with Article 3(12) of the Convention.
Article 7 read in combination with Annex III transposes Article 5 (2 and 3) and Annex B of the Convention. It prohibits the use of mercury and mercury compounds as catalyst for the production of acetaldehyde and of vinyl chloride monomer as from 1st January 2019. Regarding installations producing sodium or potassium methylate or ethylate using a mercury-based process, it establishes restrictions on the use of mercury from primary mining and on releases of mercury and mercury compounds to the environment while prohibiting, as from the date of entry into force of this Regulation, any increase of production capacity or new establishment of installations. Article 7(3) foresees the possible adoption of Commission Delegated Acts as a means to transpose Decisions of the CoP establishing requirements for the interim storage of mercury and mercury compounds when supported by the Union, thereby maintaining the application of the ordinary legislative procedure in the absence of a Union position in favour of the concerned CoP decision or when the Union would have opposed to it.
Article 8 transposes Articles 4(6 and 7) and 5(4 and 9) of the Convention. It sets a prohibition on the manufacturing and placing on the market of mercury-added products not covered by any known use prior to the date of application of this proposal and on the implementation of manufacturing processes that did not exist prior to this date. Article 8(3 and 4) establishes a mechanism by which such new mercury-added products and manufacturing processes could still be allowed by means of a Commission Implementing Act taken on the basis of an assessment of their environmental and human health benefits and of the availability of mercury-free alternatives that are technically and economically feasible.
In accordance with Article 7 of the Convention, Article 9 read in combination with Annex IV provides that Member States where ASGM occurs shall take steps to reduce, and where feasible eliminate, the use and emissions of mercury and mercury compounds resulting from such an activity and shall develop and implement a relevant national plan.
Article 10 transposes Article 4(3) and Annex A (Part II) of the Minamata Convention. It requires that dental amalgam be used only in an encapsulated form and that dental facilities be equipped with amalgam separators to retain and collect mercury-containing amalgam residues, as from 1st January 2019. It calls upon Member States to make use of relevant EN standards, as last updated, including EN ISO 138987 27 , EN ISO 24234 28 and EN 1641:2009 29 or of any other national or international standards ensuring an equivalent level of amalgam residue retention and quality of amalgam capsules.
Article 11 reproduces Article 2 of Regulation (EC) 1102/2008 by providing that mercury that is no longer used in the chlor-alkali industry or generated from the cleaning of natural gas or from non-ferrous metals mining and smelting or extracted from cinnabar ore qualifies as waste that must be disposed of.
Article 12 is based upon Article 6 of Regulation (EC) 1102/2008 and provides that the companies operating activities referred to in Article 11 shall have to provide annually to national competent authorities information regarding notably the amount of mercury stored within each installation concerned and the amount of mercury sent to temporary or permanent mercury waste storage facilities. Article 12(2) provides that information must be reported by using the relevant waste category and NACE codes, as established in Regulation (EC) No 2150/2002 30 . Article 12(3) specifies that installations producing chlor-alkali using mercury cells shall cease reporting once all those cells will have been decommissioned in accordance with Commission Implementing Decision 2013/732/EU 31 and all mercury waste has been transferred to a storage facility.
Article 13 provides that mercury waste can be temporarily or permanently stored in underground storage facilities and temporarily stored in above-ground storage facilities and specifies, for that purpose what requirements established in Council Directive 1999/31/EC for the temporary storage of mercury waste are applicable to the permanent storage of mercury waste in underground storage facilities.
Articles 14 and 20 lay down the provisions on penalties applicable to breaches of this proposal and on its entry into force and date of application.
Article 15 transposes Article 21 of the Minamata Convention by providing for an obligation for Member States to prepare, update and publish a report containing all relevant information on the implementation of this proposal, information that needs to be reported to comply with above-cited Article 21, a summary of the information gathered under Article 12 of this proposal on mercury waste from large sources and information on the significant individual stocks of mercury that may exist on the territory of each Member State. This provision specifies that the Commission must be informed of such a report and updates within one month of their publication. Article 15(2) provides for the adoption by the Commission of an Implementing Act establishing questionnaires to assist Member States to report relevant information to the Commission by specifying what precise information will have to be submitted, including information on key performance indicators, under what format and by when.
Article 16 foresees the possible adoption by the Commission of delegated acts that would amend Annexes I to IV of this proposal in order to transpose relevant Decisions adopted by the CoP when supported by the Union, thereby maintaining the application of the ordinary legislative procedure in the absence of a Union position in favour of the concerned CoP decision or when the Union would have opposed to it.
Articles 17 and 18 are standard texts for the exercise of the delegation granted to the Commission under Articles 7(3) and 16 and for the Committee procedure as a means to adopt Implementing Acts under Articles 6, 8 i and 15(2).
Article 19 stipulates that Regulation (EC) No 1102/2008 will be replaced and repealed by 1st January 2018, date where this proposal shall start to apply and that references to Regulation (EC) No 1102/2008 shall be construed as references to this proposal.
Alike Regulation (EC) No 1102/2008, this proposal seeks both to protect the environment and human health and to ensure uniformity in respect of its trade aspects (export and import prohibition and restrictions affecting mercury, mercury compounds and mercury-added products). Accordingly, this proposal has a twofold legal basis, i.e. Articles 192(1) and 207 of the Treaty on the Functioning of the European Union.
This proposal aims at transposing into the Union acquis the provisions of the Minamata Convention that are not yet covered by EU legal requirements in order to enable the Union and the Member States to ratify and implement that Convention.
In this respect, the subsidiarity principle applies insofar as this proposal does not entirely fall under the exclusive competence of the Union.
The objectives of this proposal cannot be sufficiently achieved by the Member States. To address the issue of mercury pollution and exposure in the Union, each Member State must inter alia implement an export prohibition on mercury and several mercury compounds and on certain mercury-added products and a conditional import prohibition applicable to mercury. Such trade-related measures can only be transposed and implemented on the basis of Union provisions as measures in the field of common commercial policy fall within the exclusive competence of the Union in accordance with Article 3(e) of the Treaty on the Functioning of the European Union.
Regarding the non-trade provisions of this proposal on the use of mercury in existing and new manufacturing pocesses and in new products, on the control of mercury emissions into the environment and on the storage of mercury and management of mercury waste, they belong to the category of the shared competence between the Union and the Member States, i.e. environmental and human health protection. Considering, as specified above, that the protection of the environment and of human health from mercury pollution and exposure is already extensively regulated at Union level, action by the Union is justified. As to the provisions of the Convention on ASGM, this proposal provides the concerned Member State with the choice of the optimum combination of measures to implement to achieve the relevant requirements.
This proposal therefore respects the subsidiarity principle.
The chosen legal instrument is a Regulation as the proposal lays down provisions on e.g. trade and mercury-added products, which require uniform implementation across the Union, while leaving sufficient flexibility to the Member States as regards the choice of measures for compliance with provisions on manufacturing processes and ASGM and their detailed implementation. The proposal therefore complies with the proportionality principle.
4. BUDGETARY IMPLICATION
This legislative Proposal has no budgetary implications.