2016/0023(COD) | [ParlTrack]

Proposal for a regulation
Recital 2

(2) M~~ost~~any mercury emissions and associated exposure risks result from anthropogenic activities, including primary mercury mining and processing, the use of mercury in products, industrial processes and artisanal and small-scale gold mining ("ASGM") and mercury emissions originating in particular from coal combustion and the management of mercury waste.

Amendment 103 #

Proposal for a regulation
Recital 3

(3) The seventh Environment Action Programme adopted by Decision No 1386/2013/EU of the European Parliament and of the Council34 establishes the long- term objective of a non-toxic environment and, for that purpose, stipulates that immediate action is needed to ensure the minimisation of significant adverse effects of chemicals on human health and the environment by 2020. __________________ 34 Decision No 1386/2013/EU of the European Parliament and of the Council of 20 November 2013 on a General Union Environment Action Programme to 2020 ‘Living well, within the limits of our planet’ (OJ L 354, 28.12.2013, p. 171).

Amendment 104 #

Proposal for a regulation
Recital 5

Amendment 105 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Recital 5

(5) Significant progress has been achieved in the Union in the past 10 years in the field of mercury management following the adoption of the Strategy and of a wide range of measures concerning mercury emissions, supply, demand and use and the management of mercury surplus and stocksManagement of the production of mercury, its emissions and its supply, demand and use in industrial production processes, in addition to the management of mercury surplus and stocks, must be planned with the aim of protecting the environment and health, always taking into account the precautionary principle.

Amendment 106 #

Proposal for a regulation
Recital 5

(5) Significant progress has been achieved in the Union in the past 10 years in the field of mercury management, fo~~llowing~~r example by means of the adoption of the Strategy and of a wide range of measures concerning mercury emissions, supply, demand and use and the management of mercury surplus and stocks.

Amendment 107 #

Proposal for a regulation
Recital 6

(6) ~~The Strategy~~In addition to the provisions of the mercury management strategy, which establishes that the negotiation and conclusion of an international legally- binding instrument should be a priority ~~as Union action alone cannot~~, the European Union should endeavour to excel among its global partners in order to guarantee ~~effective~~a protection of ~~the~~its citizens ~~of the Union against~~from the negative health effects of mercury that is truly effective, by setting best practice examples to all countries that are party to the Minamata Convention.

Amendment 108 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Recital 6

(6) The Strategy establishes that the negotiation and conclusion of an international ~~legally-binding~~ instrument should be a priority as Union action alone cannot guarantee effective protection of the citizens of the Union against the negative health effects of mercury.

Amendment 109 #

Proposal for a regulation
Recital 7

(7) The Union and 26 Member States have signed in Kumamoto on 11 October 2013 the Minamata Convention on Mercury ("the Convention").37 TUnlike the Union a~~nd all its Member States are therefore committed to~~s an organisation, Estonia and Portugal do not for the time being wish to be associated with its conclusion, transposition and implementation38. __________________ 37 https://treaties.un.org https://treaties.un.org 38 Council Decision XXX of XX/XX/XX on the conclusion of the Minamata Convention on Mercury (OJ L , , p. ).

Amendment 110 #

Bolesław G. PIECHA, Jadwiga WIŚNIEWSKA

Proposal for a regulation
Recital 7

(7) The Union and 26 Member States have signed in Kumamoto ~~on 11 October 2013~~ the Minamata Convention on Mercury ("the Convention")37. The Union and all its Member States are therefore committed to its conclusion, transposition and implementation38. __________________ 37 https://treaties.un.org 38 Council Decision XXX of XX/XX/XX on the conclusion of the Minamata Convention on Mercury (OJ L , , p. ).

Amendment 111 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Recital 8

(8) Swift ratification of the Convention by ~~the Union and its Member~~European States will encourage major global mercury users and emitters, that are signatories of the Convention, to ratify and implement it.

Amendment 112 #

Pilar AYUSO, Stefan ECK, Francisco de Paula GAMBUS MILLET

Proposal for a regulation
Recital 9

(9) As Union legislation already transposes many of the obligations of the Convention, this Regulation should ~~only~~ lay down provisions that complement the Union acquis and that are needed to ensure its full alignment with the Convention and, accordingly, to enable the Union and its Member States to ratify and implement it. This Regulation should also lay down new provisions that go beyond the Convention, in keeping with the Strategy and Union legislation on the environment and protection of human health, particularly in the field of waste.

Amendment 113 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Recital 9

(9) As Union legislation already transposes many of the obligations of the Convention, this Regulation should only lay down provisions that complement the Union acquis and that are needed to ensure its full alignment with the Convention and, accordingly, to enable the Union and its Member States to ratify and implement it. The sovereign wishes of Estonia and Portugal on this subject should be taken into account, while calling on those Member States, through constructive dialogue, to sign the Minamata Convention.

Amendment 114 #

Proposal for a regulation
Recital 9

(9) As Union legislation already transposes many of the obligations of the Convention, this Regulation should ~~onl~~as a priority lay down provisions that complement the Union acquis and that are needed to ensure its full alignment with the Convention and, accordingly, to enable the Union and its Member States to ratify and implement it.

Amendment 115 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Jytte GUTELAND, Christel SCHALDEMOSE, Carlos ZORRINHO, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Recital 9

Amendment 116 #

Proposal for a regulation
Recital 9 a (new)

(9a) Additional measures at Union level whose level of ambition goes beyond that of the Convention may be adopted where they make it possible to reduce the harmful effects of mercury efficiently and effectively, in accordance with the scientific state of the art, on condition that such measures do not place European businesses at a competitive disadvantage in relation to the rest of the world. By way of example, the Union should encourage the use of recycled mercury for industrial purposes.

Amendment 117 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 10

(10) The mercury export ban set out in Regulation (EC) No 1102/2008 of the European Parliament and of the Council39 should be complemented by ~~restrictions~~a ban on the import of mercury ~~depending on the source, the intended use and the place of origin of mercury~~for uses other than disposal as waste. The national authorities designated in accordance with Regulation (EU) No 649/2012 of the European Parliament and of the Council40 should perform the administrative functions linked to the implementation of such ~~restriction~~measures. __________________ 39 Regulation (EC) No 1102/2008 of the European Parliament and of the Council of 22 October 2008 on the banning of exports of metallic mercury and certain mercury compounds and mixtures and the safe storage of metallic mercury (OJ L 304, 14.11.2008, p. 75). 40 Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60).

Amendment 118 #

Gesine MEISSNER, Ulrike MÜLLER

Proposal for a regulation
Recital 10

(10) ~~The mercury export ban set out in~~In accordance with Regulation (EC) No 1102/2008 of the European Parliament and of the Council39, the mercury export ban should be complemented by restrictions on the import of mercury depending on the source, the intended use and the place of origin of mercury. The national authorities designated in accordance with Regulation (EU) No 649/2012 of the European Parliament and of the Council40 should perform the administrative functions linked to the implementation of such restrictions. __________________ 39 Regulation (EC) No 1102/2008 of the European Parliament and of the Council of 22 October 2008 on the banning of exports of metallic mercury and certain mercury compounds and mixtures and the safe storage of metallic mercury (OJ L 304, 14.11.2008, p. 75). 40 Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60).

Amendment 119 #

Proposal for a regulation
Recital 11

(11) The export, import and manufacturing of a range of mercury-added products accounting for a significant share of the use of mercury and mercury compounds within the Union and globally should be prohibited; continued use should be strictly monitored and meet the conditions set out in Articles 3 and 4 of this Regulation.

Amendment 120 #

Anneli JÄÄTTEENMÄKI, Fredrick FEDERLEY, Frédérique RIES, Jasenko SELIMOVIC

Proposal for a regulation
Recital 11

(11) The export, import and manufacturing of a range of mercury-added products accounting for a significant share of the use of mercury and mercury compounds within the Union ~~and globally~~ should be prohibited, provided that such prohibitions do not lead to an increase in the total release of mercury globally.

Amendment 121 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 11

(11) The export, import and manufacturing of a range of mercury-added products not complying with the limits established by the applicable Union legislation, and accounting for a significant share of the use of mercury and mercury compounds within the Union and globally, should be prohibited.

Amendment 122 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Recital 11 a (new)

(11a) This Regulation should not prevent the export, import and manufacturing of medicinal products providing demonstrable significant health benefits where there are no mercury-free active substances available as alternatives.

Amendment 123 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 12

(12) This Regulation should therefore have a twofold legal basis, Articles 192(1) and 207 of the TFEU, as it seeks to protect both the environment and human health and to ensure uniformity in respect of its trade aspects through the export and import prohibition and restrictions affecting mercury, mercury compounds and mercury-added products.deleted

Amendment 124 #

Proposal for a regulation
Recital 12

(12) ~~This Regulation should therefore have a twofold legal basis, Articles 192(1) and 207 of the TFEU, as it seek~~As the main objective of this Regulation is to protect both the environment and human health ~~and to ensure uniformity in resp~~from the negative effects of ~~its trade aspects through the export and import prohibition and restrictions affecting mercury, mercury compounds and mercury-added product~~mercury, this Regulation should have Article 192(1) TFEU as its legal basis.

Amendment 125 #

Anneli JÄÄTTEENMÄKI, Frédérique RIES, Jasenko SELIMOVIC

Proposal for a regulation
Recital 12

(12) This Regulation ~~should therefore have a twofold legal basis, Articles 192(1) and 207 of the TFEU, as it~~ seeks to protect both the environment and human health and to ensure uniformity in respect of its trade aspects through the export and import prohibition and restrictions affecting mercury, mercury compounds and mercury-added products, and it should have a twofold legal basis, namely Articles 192(1) and 207 of the TFEU.

Amendment 126 #

Proposal for a regulation
Recital 12

(12) This Regulation should ~~therefore have a twofold legal basis,~~have Articles 192(1) ~~and 207 of the TFEU~~TFEU as its legal basis, as it seeks to protect both the environment and human health ~~and to ensure uniformity in respect of its trade aspects through t~~. The export and import prohibition and restrictions affecting mercury, mercury compounds and mercury-added products should therefore be subject to environment and human health considerations.

Amendment 127 #

Proposal for a regulation
Recital 12 a (new)

(12a) With the aim of reducing imports of mercury and storage of mercury waste, either stabilised or partially stabilised, the use of mercury obtained by means of recycling should be encouraged where possible.

Amendment 128 #

Michel DANTIN, Françoise GROSSETÊTE, Angélique DELAHAYE

Proposal for a regulation
Recital 13

(13) This Regulation applies without prejudice to the provisions of the applicable Union acquis that set stricter requirements for such products, including in terms of their maximum content of mercury, but without being restricted to that aspect.

Amendment 129 #

Proposal for a regulation
Recital 13 a (new)

(13a) This Regulation aims to protect human health while also ensuring the availability of medicated and medicinal products containing mercury that confer proven benefits to health for which no mercury-free alternative exists.

Amendment 130 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Jytte GUTELAND, Christel SCHALDEMOSE, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Recital 13 a (new)

(13a) In accordance with Article 193 TFEU, this Regulation should not prevent Member States from maintaining or introducing more stringent protective measures, provided that such measures are compatible with the Treaties and the Commission has been notified.

Amendment 131 #

Susanne MELIOR

Proposal for a regulation
Recital 14

(14) In the absence of relevant available mercury-free production processes, operating conditions for the production of sodium or potassium methylate or ethylate involving the use of mercury should be set with a view to reducing total mercury emissions and releases from such production processes by 50 per cent by 2020 compared to 2010 in order to limit environmental and health impacts. Measures should be taken to reduce the use of mercury and to phase out its use in such production processes as quickly as possible and in any event within 10 years of the entry into force of the Convention.

Amendment 132 #

Norbert LINS, Birgit COLLIN-LANGEN

Proposal for a regulation
Recital 14

(14) In the absence of relevant available mercury-free production processes, operating conditions for the production of sodium or potassium methylate or ethylate involving the use of mercury should be set with a view to reducing total mercury emissions and releases from such production processes by 50 % by 2020 compared to 2010 in order to limit environmental and health impacts. Measures should be taken to reduce the use of mercury and to phase out its use in such production processes as quickly as possible and in any event within 10 years of the entry into force of the Convention.

Amendment 133 #

Proposal for a regulation
Recital 14

(14) ~~In the absence of relevant availabl~~Given that alternative mercury-free production processes, are available, temporary operating conditions for the production of sodium or potassium methylate or ethylate involving the use of mercury should be set. Moreover, in order to enable industry to make investments sufficiently in advance, a date needs to be set as soon as possible for the introduction of a ban on mercury in the production of sodium or potassium methylate or ethylate.

Amendment 134 #

Anneli JÄÄTTEENMÄKI, Fredrick FEDERLEY, Frédérique RIES, Jasenko SELIMOVIC, José Inácio FARIA, Gerben-Jan GERBRANDY

Proposal for a regulation
Recital 14

(14) The production of sodium or potassium methylate or ethylate by means of a process using mercury ought ultimately to be prohibited. In the absence of a relevant available mercury-free pro~~duction processes, operating condition~~cess for the production of ~~sodium or~~ potassium methylate or ethylate ~~involving the use of mercury should be set~~, the derogation period should be extended for a maximum specified period and/or until a mercury- free process has been deemed technically and economically feasible.

Amendment 135 #

Proposal for a regulation
Recital 14

(14) In the absence of relevant available mercury-free production processes, operating conditions for the production of sodium or potassium methylate or ethylate involving the use of mercury should be set. A gradual phase-out and replacement with feasible mercury-free production processes should take place as soon as possible.

Amendment 136 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Recital 14

(14) ~~In the absence of relevant available mercury-free production processes, operating conditions for the production of sodium or potassium methylate or ethylate involving the use of mercury~~The production of sodium or potassium methylate or ethylate which involves the use of mercury should be prohibited. In the absence of relevant available mercury-free production processes for potassium methylate or ethylate, operating conditions and a phasing-out period for such production should be set.

Amendment 137 #

Proposal for a regulation
Recital 15

(15) The manufacturing and placing on the market of new mercury-added products and the establishment of new mercury- based manufacturing processes would increase the use of mercury and of mercury compounds and mercury emissions within the Union. Such new activities should therefore be prohibited unless an assessment demonstrates that these uses would provide significant ~~environmental and~~ health benefits and that no ~~technically and economically feasible~~ mercury-free alternatives providing such benefits are available.

Amendment 138 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Recital 15

(15) The manufacturing and placing on the market of new mercury-added products and the establishment of new mercury- based manufacturing processes would increase the use of mercury and of mercury compounds and mercury emissions within the Union. Such new activities should therefore be prohibited unless an assessment of the risks and the benefits demonstrates that these uses would provide significant environmental and health benefits and that no technically ~~and economically~~ feasible mercury-free alternatives providing such benefits are available.

Amendment 139 #

Proposal for a regulation
Recital 16

(16) The use of mercury and mercury compounds in ASGM accounts for a significant share of mercury use and emissions worldwide, and should therefore be regulated immediately.

Amendment 140 #

Proposal for a regulation
Recital 16 a (new)

(16a) It is essential that mercury waste be traceable so as to ensure that it is properly treated and disposed of and to prevent illegal use thereof Accordingly, an effective traceability system throughout the mercury waste management chain ought to be introduced at Union level.

Amendment 141 #

Proposal for a regulation
Recital 16 a (new)

(16a) In view of efforts to develop and promote renewable energy sources in the EU Member States, the contribution of biomass to mercury emissions should be given immediate attention.

Amendment 142 #

Proposal for a regulation
Recital 16 b (new)

(16b) Buccodental health awareness- raising and education is the most effective way of preventing caries and, hence, of reducing the use of a dental restoration such as dental amalgam. Member States ought to promote buccodental health, for example by setting national objectives.

Amendment 143 #

Proposal for a regulation
Recital 17

(17) The use of dental amalgam in an encapsulated pre-dosed form and the implementation of amalgam separators should be made mandatory to protect dental practitioners and patients from mercury exposure and to ensure that resulting mercury waste are not released into the environment, but are collected and subjected to sound waste management. To ensure that amalgam separators are effective, minimum requirements for performance of equipment and amalgam waste management by practitioners ought to be guaranteed at Union level. Given the size of the undertakings from the dentristry sector concerned by this change, it is appropriate to provide sufficient time to adapt to the new provision.

Amendment 144 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 17

(17) The use of dental amalgam ~~in an encapsulated form and t~~should be prohibited for the treatment of children and pregnant and breastfeeding women, and the phasing out of its use for the treatment of all patients and in the training of dental practitioners should also be an aim. The implementation of amalgam separators with a minimum retention efficiency should be made mandatory to protect dental practitioners and patients from mercury exposure and to ensure that resulting mercury waste are not released into the environment, but are collected and subjected to sound waste management. Given the size of the undertakings from the dentristry sector concerned by this change, it is appropriate to provide sufficient time to adapt to the new provision.

Amendment 145 #

Anneli JÄÄTTEENMÄKI, Fredrick FEDERLEY, Frédérique RIES, Jasenko SELIMOVIC, Ulrike MÜLLER, José Inácio FARIA, Gerben-Jan GERBRANDY

Proposal for a regulation
Recital 17

(17) The use of dental amalgam in an encapsulated form and the implementation of amalgam separators should be made mandatory to protect dental practitioners and patients from mercury exposure and to ensure that resulting mercury waste are not released into the environment, but are collected and subjected to sound waste management. Given the size of the undertakings from the dentristy sector care already widespread in the European Union. Such measures in addition to the collection and sound management of dental amalgam and amalgam waste are considered to be sufficient in reducing mercury releases from this sector, but they fail to address the problem of perpetual demand of mercury in the Union and the negative impact on the environment. To protect dental practitioncer~~ned by this change, it is appropriate to provide sufficient time to adapt to the new provision~~s, patients and the environment from mercury exposure, the use of dental amalgam should be phased out, as is already the case in several Union countries.

Amendment 146 #

Proposal for a regulation
Recital 17

Amendment 147 #

Proposal for a regulation
Recital 17

(17) TPending the total elimination of the use of mercury in dentistry, the use of dental amalgam in an encapsulated form and the implementation of amalgam separators should be made mandatory to protect dental practitioners and patients from mercury exposure and to ensure that resulting mercury waste ~~are~~is not released into the environment, but ~~are~~is collected and subjected to sound waste management. ~~Given the size of the undertakings from the dentristy sector concerned by this change, it is appropriate to provide sufficient time to adapt to the new provision.~~

Amendment 148 #

Proposal for a regulation
Recital 17

Amendment 149 #

Proposal for a regulation
Recital 17 a (new)

(17a) Member States should be called on to support the training of students and dentists in the use of mercury-free alternatives, in particular for vulnerable groups such as pregnant women and children, and to encourage buccodental health research and innovation in order to improve knowledge of existing materials and restoration techniques and to develop new materials.

Amendment 150 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Jytte GUTELAND, Christel SCHALDEMOSE, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 17 a (new)

(17a) Parties to the Minamata Convention have committed to take measures to encourage professional organisations and dental schools to educate and train dental professionals and students on the use of mercury-free dental restoration alternatives and on promoting best management practices; such measures should be taken into account when reviewing Directive 2005/36/EC of the European Parliament and of the Council1a. __________________ 1aDirective 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22).

Amendment 151 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Jytte GUTELAND, Christel SCHALDEMOSE, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 17 b (new)

(17b) Permanent storage of metallic mercury should be avoided in order to ensure its non-availability as a commodity. In order to ensure its long- term safe disposal, metallic mercury should be transformed into a solidified form prior to permanent storage.

Amendment 152 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 17 c (new)

(17c) Over 6 000 tonnes of metallic mercury waste will be generated in the Union by 2017, mainly as a result of the mandatory decommissioning of mercury cells in the chlor-alkali industry in accordance with Commission Implementing Decision 2013/732/EU1a. Given the limited available capacity for undertaking the solidification of liquid mercury waste, the temporary storage of liquid mercury waste should still be allowed under this Regulation, for a period of time sufficient to ensure the solidification of all such waste generated, but only in above ground facilities. __________________ 1aCommission Implementing Decision 2013/732/EU of 9 December 2013 establishing the best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions, for the production of chlor- alkali (OJ L 332, 11.12.2013, p. 34).

Amendment 153 #

Proposal for a regulation
Recital 18

Amendment 154 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 18

Amendment 155 #

Proposal for a regulation
Recital 18

(18) ~~Most of the criteria established in Council Directive 1999/31/EC41 for the temporary~~The permanent storage of liquid mercury ~~waste~~ should ~~apply to the permanent storage of mercury was~~be prohibited in unorderground storage facilities. The applicability of some of those criteria should depend on the specific characteristics of each underground storage facility, as determined by the competent authorities of the Member States in charge of the implementation of Directive 1999/31/EC. __________________ 41Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182 of 16.7.1999, p. 1) to prevent harm to human health and the environment and to prevent the illegal use thereof.

Amendment 156 #

Proposal for a regulation
Recital 18

(18) Most of the criteria established in Council Directive 1999/31/EC41 for the temporary storage of mercury waste should apply to the permanent storage of mercury waste in underground storage facilities. The applicability of some of those criteria should depend on the specific characteristics of each underground storage facility, as determined by the competent authorities ofercury waste should be solidified prior to any final disposal. Temporary storage for a limited period of time is necessary in light of limited capacities for solidification. Given the recurring problems of stability of underground storage facilities, solidified mercury waste should only be disposed of above ground in adequate facilities under adequate conditions. Most of the criteria established in Council Directive1999/31/EC41 for the Mtem~~ber States in charge of the implementation of Directive 1999/31/EC~~porary storage of mercury waste should apply to the permanent disposal of solidified mercury waste. __________________ 41 Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182 of 16.7.1999, p. 1).

Amendment 157 #

Pilar AYUSO, Stefan ECK, Francisco de Paula GAMBUS MILLET

Proposal for a regulation
Recital 18 a (new)

(18a) Contaminated sites contribute to re-mobilisation and re-emissions and releases of mercury to air, soil and water. In the absence of comprehensive information about abandoned contaminated sites, the development of an inventory and guidelines for the management of all contaminated sites in the Union is necessary. In order to allow for that development, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of laying down the methods and approaches for the ecologically sustainable management and remediation of sites contaminated by mercury or mercury compounds, in line with the polluter pays principle.

Amendment 158 #

Proposal for a regulation
Recital 18 a (new)

(18a) The permanent storage without pre-treatment of metallic mercury that is considered as waste should be ruled out owing to the risks it poses, as an extremely hazardous substance in its liquid state. Prior to the permanent storage of mercury waste, the relevant operations to stabilise and solidify such waste must be carried out in order to reduce these risks, in keeping with Article 6 of Directive 1999/31/EC. The permanent storage (or disposal) of mercury waste will be permitted only after it has been solidified.

Amendment 159 #

Pilar AYUSO, Stefan ECK, Francisco de Paula GAMBUS MILLET

Proposal for a regulation
Recital 18 b (new)

(18b) The safety of permanent storage underground or in salt mines should be carefully analysed, since there are no studies that adequately assess the risks linked to this form of storage for mercury waste. The Commission may draw up recommendations for the characteristics of facilities for the permanent storage of mercury waste. It may also propose a revision of Directive 1999/31/EC.

Amendment 160 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 19

(19) In order to align Union legislation with Decisions of the Conference of the Parties of the Convention supported by the Union, the power to adopt acts in accordance with Article 290 ~~of the~~ TFEU should be delegated to the Commission in respect of amending the annexes to this Regulation ~~and supplementing this Regulation with technical requirements for environmentally sound interim storage of mercury and mercury compounds~~. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

Amendment 161 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Recital 20

(20) ~~In order to ensure uniform conditions for the implementation of this Regulation with regard to~~The power to adopt acts in accordance with Article 290 TFEU should also be delegated to the Commission in respect of prohibiting or allowing new ~~mercury using~~ products and processes and reporting obligations, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and the Council42. __________________ 42 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)using mercury and in respect of setting technical requirements for environmentally sound interim storage of mercury, mercury compounds and mixtures of mercury.

Amendment 162 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Recital 24

(24) Since the objective of this Regulation, namely to ensure a high level of protection of human health and the environment from mercury, by means of a mercury and mercury-added product export and import prohibition, of restrictions on mercury use in manufacturing processes, products, ASGM, through the use of mercury, and dental amalgam and of obligations applicable to mercury waste, cannot be sufficiently achieved by Member States, but can rather, by reason of the transboundary nature of mercury pollution and the nature of the measures to be taken, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

Amendment 163 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Article 1 – paragraph 1

This Regulation establishes measures and conditions concerning the trade, manufacture, use and ~~interim~~ storage of mercury, mercury compounds, mixtures, mercury- added products and the management of mercury waste.

Amendment 164 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Article 2 – paragraph 1 – point 1 a (new)

1a. '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;

Amendment 165 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Article 2 – paragraph 1 – point 6

6. 'primary mercury mining' means mining in which the principal material sought is mercury. Mining must not be confused with more than insignificant ASGM and processing activities, which may give rise to the use of mercury and mercury compounds.

Amendment 166 #

Proposal for a regulation
Article 2 – paragraph 1 – point 6 a (new)

6a. 'temporary storage' means the storage of mercury or mercury compounds, that have been defined as waste, for a limited period of time before being subsequently solidified and disposed of;

Amendment 167 #

Gesine MEISSNER, Ulrike MÜLLER

Proposal for a regulation
Article 2 – paragraph 1 – point 6 a (new)

6a. 'temporary storage' means the storage of mercury waste for a limited period prior to the final-disposal process.

Amendment 168 #

Peter LIESE, Jens GIESEKE, Ingeborg GRÄSSLE, Norbert LINS, Birgit COLLIN-LANGEN, Michel DANTIN, Renate SOMMER

Proposal for a regulation
Article 3 – paragraph 1 – subparagraph 2

The first subparagraph shall not apply to the export of the mercury compounds listed in Annex I for laboratory-scale research, for mercury in pre-dosed capsules for the in-situ generation of dental amalgam, for vaccines and substances for allergy testing and for mercury or mercury compounds intended for the manufacture of homeopathic and anthroposophic medicinal products or their active pharmaceutical ingredients.

Amendment 169 #

Proposal for a regulation
Article 3 – paragraph 1 – subparagraph 2 a (new)

The first subparagraph shall not apply to the export of mercury and of mercury compounds and mixtures listed in Annex I used as starting material for active pharmaceutical ingredients in homeopathic preparations manufactured in accordance with the European Pharmacopeia, if the following conditions are met: - the manufacturer compiles and submits an annual compliance report in relation to any activities involving mercury to the national competent authority; - the medicinal product is authorised by a national competent authority to be marketed as a medicinal product; and - the manufacturer complies with the safety-assessment requirements for such products set out by the competent national authority.

Amendment 170 #

Anneli JÄÄTTEENMÄKI, Fredrick FEDERLEY, Frédérique RIES, Jasenko SELIMOVIC

Proposal for a regulation
Article 3 – paragraph 2

2. The export of mixtures of mercury not listed in Annex I for the purposes of recovering the mercury shall be prohibited outside the European Union, the European Economic Area and Switzerland.

Amendment 171 #

Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1

The import of mercury, and of mercury compounds and mixtures listed in Annex I ~~for uses oth~~, shall be prohibited. However, th~~an disposal as waste shall be prohibited~~e import of mercury and of mixtures listed in Annex I for disposal shall be prohibited as of 1 January 2028.

Amendment 172 #

Gesine MEISSNER, Ulrike MÜLLER

Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1

The import of mercury and of mixtures as listed in Annex I for uses other than disposal as waste shall be prohibited.

Amendment 173 #

Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1 a (new)

The import of mercury and of mercury compounds and mixtures listed in Annex I shall be permitted if used as starting material for active pharmaceutical ingredients in homeopathic preparations manufactured in accordance with the European Pharmacopeia, if the following conditions are met: - the manufacturer compiles and submits an annual compliance report in relation to any activities with mercury to the national competent authority; - the medicinal product is authorised by a national competent authority to be marketed as a medicinal product; and - the manufacturer complies with the safety-assessment requirements for such products set out by the competent national authority.

Amendment 174 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Jytte GUTELAND, Christel SCHALDEMOSE, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 2

By way of derogation from the first subparagraph, import shall be allowed in any of the following circumstances: - the Convention and the exported mercury is not from primary mercury mining as set out in Article 3(3) and (4), of that Convention; - Party to the Convention has provided certification that the mercury is not from primary mercury mining and not from the chlor-alkali industry, and the importing Member State has granted its written consent to the import.deleted the exporting country is a Party to the exporting country not being a

Amendment 175 #

Michel DANTIN, Françoise GROSSETÊTE, Angélique DELAHAYE

Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 2 – indent 2 a (new)

- the mercury and mixtures listed in Annex I are used for the production of medicated and medicinal products, without prejudice to either of the above instances.

Amendment 176 #

Proposal for a regulation
Article 4 – paragraph 1 a (new)

1a. By way of derogation from the first subparagraph, import shall be allowed only where recycled mercury is no longer available and provided that the use thereof is technically possible and/or does not affect product quality.

Amendment 177 #

Proposal for a regulation
Article 4 – paragraph 2

~~2. The import of mercury for use in artisanal and small-scale gold mining shall be prohibi~~deleted.

Amendment 178 #

Proposal for a regulation
Article 4 – paragraph 3

3. The national authority or authorities designated in accordance with Article 4 of Regulation (EU) No 649/2012 shall carry out the administrative functions resulting from the requirements laid down in paragraphs 1 and 2 of this Article.deleted

Amendment 179 #

Stefan ECK

Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 1 a (new)

The Commission shall identify the financial and technical means for contributing to the capacity-building and the transfer of technical assistance and technology pursuant to the obligations deriving from the Minamata Convention. The Commission in collaboration with Member States and relevant stakeholders shall promote and facilitate the development, transfer and diffusion of, and access to, up-to-date environmentally sound alternative technologies to developing country Parties, in particular the least developed countries, so as to strengthen their capacity to effectively implement the Minamata Convention. This obligation shall include all areas and phases of the elaboration of mercury, including the disposal as waste.

Amendment 180 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Article 5 – paragraph 1

1. Without prejudice to stricter requirements set out in other applicable Union legislation, the export, import and the manufacturing in the Union of the mercury-added products as set out in Annex II shall be prohibited as from ~~1 January 2021~~the dates specified therein.

Amendment 181 #

Proposal for a regulation
Article 5 – paragraph 1

1. Without prejudice to stricter requirements set out in other applicable Union legislation, the export, import and the manufacturing in the Union of ~~the~~ mercury-added products ~~as set out in Annex II~~ shall be prohibited from 1 January 2021.

Amendment 182 #

Proposal for a regulation
Article 5 – paragraph 1

Amendment 183 #

Proposal for a regulation
Article 5 – paragraph 2 – indent 1

~~- products essential for civil protection and military uses;~~deleted

Amendment 184 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Article 5 – paragraph 2 – indent 2 a (new)

- medicinal products, authorised to be marketed by a national competent authority at the date of entry into force of this Regulation, and providing demonstrable significant health benefits for which there are no technically feasible mercury-free alternatives.

Amendment 185 #

Michel DANTIN, Françoise GROSSETÊTE, Angélique DELAHAYE

Proposal for a regulation
Article 5 – paragraph 2 – indent 2 a (new)

- the parties shall, however, undertake to make efforts to limit exports and imports of mercury-added products, including those referred to in the above subparagraph.

Amendment 186 #

Proposal for a regulation
Article 5 – paragraph 2 – indent 2 a (new)

- medicated and medicinal products for which there is no feasible mercury- free alternative.

Amendment 187 #

Proposal for a regulation
Article 5 – paragraph 2 a (new)

2a. The Commission shall undertake an expert assessment of mercury use in the manufacture of vaccines, as also mentioned in the Council conclusions of 24 June 2005 and the European Parliament Resolution of March 2006, with a view to achieving a restriction of such use and, when appropriate and safe alternatives exist, a total ban, and to support research into viable options for the future delivery of thiomersal-free multi-dose vaccines in developing countries.

Amendment 188 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Article 5 – paragraph 2 a (new)

2a. Based on the list of mercury-added products established pursuant to paragraph 1, the Commission shall where appropriate present a legislative proposal in order to regulate all mercury-added products that are not yet regulated in the Union.

Amendment 189 #

Proposal for a regulation
Article 6 – paragraph 1

The Commission shall ~~adopt~~propose decisions~~, by means of implementing acts,~~ to specify the forms to be used for the purpose of implementing Articles 3 and 4.

Amendment 190 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Article 6 – paragraph 2

~~Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).~~deleted

Amendment 191 #

Proposal for a regulation
Article 7 – paragraph 2 a (new)

2a. From 1 January 2019 onwards, the maximum permissible concentration threshold of mercury and mercury compounds in any fuel or waste prior to its combustion shall not exceed 25μg/kg weight/weight (dry).

Amendment 192 #

Proposal for a regulation
Article 7 – paragraph 2 a (new)

Amendment 193 #

Proposal for a regulation
Article 7 – paragraph 3 – subparagraph 2

The Commission shall be empowered to adopt delegated acts in accordance with Article 17 in order to set out requirements for environmentally sound interim storage of mercury and mercury compounds adopted by the Conference of the Parties to the Convention~~, where the Union has supported the Decision concerned~~.

Amendment 194 #

Proposal for a regulation
Article 8 – paragraph 1

1. The manufacture and placing on the market of mercury-added products not covered by any known use prior to ~~1 January 2018~~the date of entry into force of this Regulation shall be prohibited.

Amendment 195 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Jytte GUTELAND

Proposal for a regulation
Article 8 – paragraph 1

1. The manufacture and placing on the market of mercury-added products not covered by any ~~known~~approved use prior to 1 January 2018 shall be prohibited.

Amendment 196 #

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1

Manufacturing processes involving the use of mercury and/or mercury compounds that did not exist prior to ~~1 January 2018~~the entry into force of this Regulation shall be prohibited.

Amendment 197 #

Pilar AYUSO, Stefan ECK, Francisco de Paula GAMBUS MILLET

Proposal for a regulation
Article 8 – paragraph 3 – introductory part

3. By way of derogation from paragraphs 1 and 2, where an economic operator intends to manufacture and/or place on the market a new mercury-added product or to operate a new manufacturing process, the operator shall notify the competent authorities of the Member State concerned and provide them, also by way of derogation from the rules on the industrial protection of technical documentation, with the following:

Amendment 198 #

Proposal for a regulation
Article 8 – paragraph 3 – indent 1 a (new)

- evidence showing that there are no technological alternatives to the use of mercury for the product or process,

Amendment 199 #

Proposal for a regulation
Article 8 – paragraph 3 – indent 2

- an assessment of its environmental and health risks and benefits,

Amendment 200 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Article 8 – paragraph 3 – indent 2

- an assessment of its environmental and health risks and benefits;

Amendment 201 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Article 8 – paragraph 3 – indent 2 a (new)

- information on the absence of technically feasible mercury-free alternatives providing such benefits;

Amendment 202 #

Daciana Octavia SÂRBU, Pavel POC

Proposal for a regulation
Article 8 – paragraph 3 – indent 2 a (new)

- information on the lack of a mercury-free alternative that is technically or economically feasible;

Amendment 203 #

Proposal for a regulation
Article 8 – paragraph 3 – indent 3

- a detailed explanation of the manner in which such product or process must be manufactured, used ~~and operated~~, operated, and, in the case of products, disposed of to ensure a high level of protection of the environment and of human health.

Amendment 204 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 1

Upon notification by the Member State concerned, the Commission shall verify in particular whether it has been demonstrated that the new mercury-added product or new manufacturing process would provide significant environmental and health benefits and that no technically ~~and economically~~ feasible mercury-free alternatives providing such benefits are available.

Amendment 205 #

Pilar AYUSO, Stefan ECK, Francisco de Paula GAMBUS MILLET

Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 2

The Commission shall adopt decisions, by means of implementing acts, in view of specifying whether the relevant new mercury-added product or new manufacturing process is allowed. The Member State concerned may not authorise the new product or process before the Commission has adopted its decision.

Amendment 206 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 2

The Commission shall ~~adopt~~propose decisions~~, by means of implementing acts,~~ in view of specifying whether the relevant new mercury-added product or new manufacturing process is allowed.

Amendment 207 #

Mireille D'ORNANO, Sylvie GODDYN, Jean-François JALKH

Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 3

~~Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 18(2).~~deleted

Amendment 208 #

Anneli JÄÄTTEENMÄKI, Fredrick FEDERLEY, Frédérique RIES, Jasenko SELIMOVIC, Gerben-Jan GERBRANDY

Proposal for a regulation
Article 9 – paragraph 1 – indent 1

- ~~take steps to reduce, and where feasible eliminate, the use of mercury and mercury compounds in, and the emissions and releases to the environment of mercury from,~~prohibit the use of mercury and mercury compounds in such mining and processing;

Amendment 209 #

Proposal for a regulation
Article 9 – paragraph 1 – indent 1

- take steps to reduce, and ~~where feasible eliminate,~~phase out the use of mercury and mercury compounds in, and the emissions and releases to the environment of mercury from, such mining and processing;

Amendment 210 #

Proposal for a regulation
Article 10 – paragraph 1

1. ~~From 1 January 2019 onwards~~Within 12 months of the entry into force of this Regulation dental amalgam shall only be used in an encapsulated form.

Amendment 211 #

Proposal for a regulation
Article 10 – paragraph 1

1. From 1 January 201~~9 onwards de~~8 and untail ~~amalgam shall only be used in an encapsulated for~~1 January 2020, dentists shall offer alternatives to dental amalgam.

Amendment 212 #

Proposal for a regulation
Article 10 – paragraph 1

1. From 1 January 2019 onwards dental amalgam shall only be used in an pre-dosed encapsulated form.

Amendment 213 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Article 10 – paragraph 1

1. From 1 January 20198 onwards dental amalgam shall only be used in an encapsulated form.

Amendment 214 #

Proposal for a regulation
Article 10 – paragraph 1 a (new)

1a. Member States shall ensure that every dental facility provides at least the following information with regard to dental amalgam and its alternatives to patients: - the composition of dental amalgam; - the availability of alternative mercury-free fillings and their composition; and - that the use of dental amalgam is not indicated for primary teeth, for patients with mercury allergies and for persons with chronic kidney diseases with decreased renal clearance.

Amendment 215 #

Anneli JÄÄTTEENMÄKI, Frédérique RIES, Ulrike MÜLLER, José Inácio FARIA, Jasenko SELIMOVIC, Gerben-Jan GERBRANDY, Stefan ECK

Proposal for a regulation
Article 10 – paragraph 1 a (new)

1a. From 1 January 2019 onwards, the use of dental amalgam shall be banned in the context of dental repair work carried out on pregnant women or on milk teeth, except in cases where the practitioner regards it as necessary on the grounds that there is no satisfactory alternative.

Amendment 216 #

Proposal for a regulation
Article 10 – paragraph 1 a (new)

1a. From one year after the entry into force of this Regulation, dental amalgam shall not be used for the treatment of pregnant or breastfeeding women or children who undergo treatment on their deciduous teeth.

Amendment 217 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Article 10 – paragraph 1 a (new)

1a. From 1 January 2018, dental amalgam shall not be used for the treatment of children under 12 years old and of pregnant and breastfeeding women.

Amendment 218 #

Proposal for a regulation
Article 10 – paragraph 1 a (new)

1a. From 1 January 2020 onwards, dental amalgam in any form shall not be used.

Amendment 219 #

Proposal for a regulation
Article 10 – paragraph 1 b (new)

1b. By way of derogation from paragraph1a, Member States may allow use of dental amalgam in respect of specific medical needs when no other alternatives are suitable.

Amendment 220 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Article 10 – paragraph 1 b (new)

1b. The use of dental amalgam shall be phased-out by 31 December 2021.

Amendment 221 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Article 10 – paragraph 1 c (new)

1c. By way of derogation from paragraphs 1a and 1b, the use of dental amalgam shall continue to be allowed only when deemed necessary by the dental practitioner.

Amendment 222 #

Proposal for a regulation
Article 10 – paragraph 1 c (new)

1c. From 1 January 2018 and until 1 January 2020, and when paragraph 1b applies, dental amalgam shall only be used in pre-dosed encapsulated form.

Amendment 223 #

Bolesław G. PIECHA, Jadwiga WIŚNIEWSKA

Proposal for a regulation
Article 10 – paragraph 2

2. From 1 January 20219 onwards dental facilities shall be equipped with amalgam separators aimed at retaining and collecting all amalgam particles~~. Those separators shall b~~, including those contained in liquid waste. Practitioners shall take steps to ensure that separators are maintained as required to ensure a high and ongoing level of retention of at least 95% of amalgam particles.

Amendment 224 #

Andrzej GRZYB

Proposal for a regulation
Article 10 – paragraph 2

2. From 1 January 20219 onwards dental facilities ~~shall b~~using dental amalgam or removing dental amalgam fillings shall ensure that their facilities are equipped with amalgam separators aimed at retaining and collecting amalgam particles. Those separators shall be maintained as required to ensure a high level of retention.

Amendment 225 #

Proposal for a regulation
Article 10 – paragraph 2

2. From 1 January 20219 onwards dental facilities using or removing dental amalgam shall be equipped with amalgam separators aimed at retaining and collecting amalgam particles. Those separators shall be maintained as required to ensure a high level of retention.

Amendment 226 #

Proposal for a regulation
Article 10 – paragraph 2

2. ~~From 1 January 2019 onwards~~Within six months of the entry into force of this Regulation dental facilities shall be equipped with amalgam separators aimed at retaining and collecting amalgam particles. Those separators shall be maintained as required to ensure a high level of retention.

Amendment 227 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Tibor SZANYI, Nicola CAPUTO, Jytte GUTELAND, Christel SCHALDEMOSE, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO

Proposal for a regulation
Article 10 – paragraph 2

2. From 1 January 20198 onwards dental facilities shall be equipped with amalgam separators aimed at retaining and collecting amalgam particles. Those separators shall be maintained as required to ensure a ~~high level of retention~~retention of at least 95 % of the amalgam particles.

Amendment 228 #

Julie GIRLING

Proposal for a regulation
Article 10 – paragraph 2 a (new)

2a. By no later than 31 December 2019, the Commission shall submit a report to the European Parliament and the Council assessing the technical, environmental, and economic feasibility of phasing out the use of dental amalgam within the Union by 31 December 2021.

Amendment 229 #

Proposal for a regulation
Article 10 – paragraph 3

3. Capsules and amalgam separators complying with harmonised EN standards or with other national or international standards that ensure an equivalent level of quality and of level retention shall be presumed to satisfy the requirement set out under paragraphs 1c and 2.

Amendment 230 #

Proposal for a regulation
Article 10 – paragraph 3 a (new)

3a. Member States may provide for tax incentives to enable dentists to equip themselves with the capsules and amalgam separators referred to in this Article.

Amendment 231 #

Proposal for a regulation
Article 10 – paragraph 3 a (new)

3a. Practitioners shall be responsible for the conditioning and disposal of their waste and must make sure that these stages are carried out in an environmentally sound manner. They must satisfy themselves that the service providers who collect their waste comply with the rules in force.

Amendment 232 #

Proposal for a regulation
Article 10 – paragraph 3 a (new)

3a. Notwithstanding paragraphs 1 to2, Member States may further restrict, as they deem necessary, the use of dental amalgam.

Amendment 233 #

Proposal for a regulation
Article 10 – paragraph 3 a (new)

3a. The use of dental amalgam shall be prohibited as from 31 December 2020.

Amendment 234 #

Proposal for a regulation
Chapter 3 a (new)

Chapter IIIa Prevention and control of mercury emissions from industrial activities Article 10a Industrial activities All permits for the following industrial activities shall include conditions ensuring that emissions into the air and water do not exceed the stricter emission levels associated with the best available techniques (BAT) for mercury set out in the revised BAT conclusions: - large combustion plants referred to in Article 28 of Directive 2010/75/EU of the European Parliament and of the Council1a; - the iron and steel sector covered by the activities specified in points 1.3, 2.1 and 2.2 of Annex I to Directive 2010/75/EU; - the production of cement, lime and magnesium oxide covered by the activities specified in point 3.1 of Annex I to Directive 2010/75/EU; - the non-ferrous metal sector covered by the activities specified in points 2.1, 2.5 and 6.8 of Annex I to Directive 2010/75/EU. ______________ 1a Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p.17).

Amendment 235 #

Proposal for a regulation
Article 10 a (new)

Article 10a Prevention and control of mercury emissions from industrial activities - large combustion plants - emissions to air From 1 January 2021 onwards all permits for combustion plants referred to in Article 28 of Directive 2010/75/EU shall include conditions ensuring that emissions into the air do not exceed the following emission limit values to air: (a) combustion plants with a total rated thermal input >300MWth: 1µg/Nm³; (b) combustion plants with a total rated thermal input <300MWth: 3.5 µg/Nm³. The emission limit values referred to in the first subparagraph are based on an average over a period of one year of valid hourly averages obtained by continuous measurements. The standard conditions and monitoring requirements to be used are those set out in the revised BAT conclusions of the Large Combustion Plants Reference Document.

Amendment 236 #

Proposal for a regulation
Article 10 a (new)

Article 10a Emissions to air From 1 January 2019 onwards, all permits for installations covered by the activities specified in points 1.3, 2.1 and 2.2 of Annex I to Directive 2010/75/EU shall include conditions ensuring that emissions into the air do not exceed 10µg/Nm³ for mercury. The emission limit values referred to in the first subparagraph are based on an average over a period of one year of valid hourly averages obtained by continuous measurements. The standard conditions to be used are those set out in the BAT conclusions of the Commission Implementing Decision 2012/135/EU1a. ______________ 1a Commission Implementing Decision 2012/135/EU of 28 February 2012 establishing the best available techniques (BAT) conclusions under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions for iron and steel production (OJ L 70, 8.3.2012, p. 63).

Amendment 237 #

Proposal for a regulation
Article 10 a (new)

Article 10 a Vaccines Pharmaceutical companies shall no longer use mercury in vaccines for children below six years of age where safer alternatives are available.

Amendment 238 #

Proposal for a regulation
Article 10 b (new)

Article 10b Emissions to water From 1 January 2021 Member States shall ensure that for installations referred to in Council Directive 91/271/EEC 1amercury emissions in waste water streams do not exceed 3µg/l at discharge point. The same limit shall apply to all input waste streams received at the installation in question prior to mixing with other waste water streams. The limit shall apply where a mercury release threshold of 1 000 grams per year is exceeded. The emission limit values are based on a daily average of flow-weighted 24-hour flow-proportional composite samples. The monitoring and sampling frequency set may be reduced in case of emissions proven to be sufficiently stable, in particular when Member States have fully implemented a ban of dental amalgam and taken all appropriate measures to prevent dental amalgam entering upstream waste water streams for the installation concerned. ______________ 1a Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment (OJ L 135 30.5.1991, p. 40).

Amendment 239 #

Proposal for a regulation
Article 10 b (new)

Article 10b Prevention and control of mercury emissions from industrial activities - iron and steel - emissions to air From [date of entry into force of this Regulation] onwards, all permits for installations covered by the activities specified in points 1.3, 2.1 and 2.2 of Annex I to Directive 2010/75/EU shall include conditions ensuring that emissions into the air do not exceed the following emission limit values: (a) 10µg/Nm³ for mercury; (b) 5 mg/Nm for dust. The emission limit values referred to in the first subparagraph are based on an average over a period of one year of valid hourly averages obtained by continuous measurements. The standard conditions to be used are those set out in the BAT conclusions of the Commission Implementing Decision2012/135/EU.

Amendment 240 #

Proposal for a regulation
Article 10 c (new)

Article 10c Prevention and control of mercury emissions from industrial activities - cement, lime and magnesium oxide production - emissions to air From [date of entry into force of this Regulation] onwards, all permits for installations covered by the activities specified in point 3.1 of Annex I to Directive 2010/75/EU shall include conditions ensuring that emissions into the air do not exceed 10µg/Nm³ for mercury. The emission limit values referred to in the first subparagraph are based on an average over a period of one year of valid hourly averages obtained by continuous measurements. The standard conditions to be used are those set out in the BAT conclusions of the Commission Implementing Decision2013/163/EU1a. ______________ 1a Commission Implementing Decision 2013/163/EU of 26 March 2013 establishing the best available techniques (BAT) conclusions under Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions for the production of cement, lime and magnesium oxide (OJ L 100, 9.4.2013, p. 1).

Amendment 241 #

Proposal for a regulation
Article 10 d (new)

Article 10d Prevention and control of mercury emissions from industrial activities - non- ferrous metals - emissions to air From 1 July 2020 onwards, all permits for installations covered by the activities specified in points 2.1, 2.5 and 6.8 of Annex I to Directive 2010/75/EU shall include conditions ensuring that emissions into the air do not exceed 10µg/Nm³ for mercury. The emission limit values referred to in the first subparagraph are based on an average over a period of one year of valid hourly averages obtained by continuous measurements. The standard conditions to be used are those set out in the BAT conclusions of the Commission Implementing Decision (EU) 2016/10321a. ______________ 1a Commission Implementing Decision (EU) 2016/1032 of 13 June 2016 establishing best available techniques (BAT) conclusions, under Directive 2010/75/EU of the European Parliament and of the Council, for the non-ferrous metals industries (OJ L 174, 30.6.2016, p. 32).

Amendment 242 #

Proposal for a regulation
Article 10 e (new)

Article 10e Prevention and control of mercury emissions from industrial activities - emissions to water From 1 January 2021 onwards all permits for installations referred to in Annex I of Directive 2010/75/EU shall include conditions ensuring that mercury emissions in waste water streams do not exceed the following emission limit values prior to discharge point, or in case of indirect discharges, prior to mixing with other waste water streams: (a) 0.75µg/l for waste water from installations covered by the activities specified in points 1.1 and 1.2 of Annex I to Directive 2010/75/EU; (b) 0.75µg/l for waste water from activities covered by the activities specified in points 3(a) and 3(b) of Annex I to Regulation (EC) No 166/20061a. Where point 3(b) concerns lignite, the threshold of the surface of the area is brought to above 5 hectares if effectively under extractive operation and above 10 hectares if this concerns waste water treatment from mining operations that stopped or will stop by 2020; (c) 1 µg/l for waste water from installations covered by the activities specified in points 4.1, 4.2 and 6.11 of Annex I to Directive 2010/75/EU; (d) 1 µg/l for waste water from installations covered by the activities specified in points 2.2 and 2.5 of Annex I to Directive 2010/75/EU; (e) 3µg/l for other installations covered by the activities specified in Annex I to Directive 2010/75/EU where the mercury release threshold does exceed 800 grams per year. The emission limit values referred to in the first subparagraph are based on a daily average of flow-weighted 24-hour flow-proportional composite samples. ______________ 1a Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (OJ L 033, 4.2.2006, p.1).

Amendment 243 #

Proposal for a regulation
Article 10 f (new)

Article 10f Prevention and control of mercury emissions from urban waste water treatment plants - emissions to water From 1 January 2021 onwards Member States shall ensure that for installations referred to in Council Directive 91/271/EEC1a mercury emissions in waste water streams do not exceed 3µg/l at discharge point, or in case of indirect discharges, prior to mixing with other waste water stream. These limits shall apply provided a mercury release threshold of 1000 grams per year is exceeded. The emission limit values referred to in the first subparagraph are based on a daily average of flow-weighted 24-hour flow-proportional composite samples. The monitoring and sampling frequency set in Annex I may be reduced in case of emissions proven to be sufficiently stable, in particular when Member States have fully implemented a ban of dental amalgam and taken all appropriate measures to prevent dental amalgam to enter in upstream waste water streams for the installation concerned. ______________ 1a Council Directive (91/271/EEC) of 21 May 1991 concerning urban waste water treatment (OJ L 135 30.5.1991, p. 40).

Amendment 244 #

Proposal for a regulation
Article 11 – title

MSources of mercury waste

Amendment 245 #

Proposal for a regulation
Article 11 – paragraph 1 – introductory part

~~Without prejudice to Commission Decision 2000/532/EC44, t~~The following shall be considered as waste and be disposed of without endangering human health or harming the environment in accordance with Directive 2008/98/EC: __________________ 44 Commission Decision 2000/532/EC of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3).

Amendment 246 #

Proposal for a regulation
Article 11 – paragraph 1 – introductory part

Without prejudice to Commission Decision 2000/532/EC44, the following shall be considered as waste and be disposed of without endangering human health or harming the environment in accordance with Directive 2008/98/EC: __________________ 44 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3).(Does not affect the English version.) Commission Decision 2000/532/EC of 3

Amendment 247 #

Proposal for a regulation
Article 11 – paragraph 1 a (new)

1a. The Commission is empowered to adopt, not later than 1 January 2019, delegated acts in accordance with Article 17 of this Regulation, in order to supplement this Regulation by setting out thresholds for mercury levels in waste containing or contaminated with mercury compounds, and by adopting requirements for the environmentally sound management of such waste streams.

Amendment 248 #

Proposal for a regulation
Article 12 – paragraph 1

1. The companies operating within the industry sectors referred to in points (a), (b) and (c) of Article 11 shall send each year by 31 May to the competent authorities of the Member States concerned data related to the total amount of mercury waste stored in each installation and sent to individual temporary ~~or permanent storage~~storage facilities, solidification facilities and final disposal facilities as well as the location and contact details of those facilities.

Amendment 249 #

Proposal for a regulation
Article 13 – title

~~Disposal~~Temporary storage of mercury waste

Amendment 250 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Article 13 – paragraph -1 (new)

-1. Mercury waste shall be permanently stored in solidified form in salt mines that are adapted for the disposal of mercury, or in deep underground hard rock formations providing a level of safety and confinement equivalent to that of such salt mines;

Amendment 251 #

Proposal for a regulation
Article 13 – paragraph -1 (new)

-1. Mercury waste shall undergo solidification into mercury sulphide prior to any disposal.

Amendment 252 #

Massimo PAOLUCCI, Damiano ZOFFOLI, Susanne MELIOR, Tibor SZANYI, Nicola CAPUTO, Carlos ZORRINHO, Elena GENTILE, Simona BONAFÈ, Renata BRIANO, Miriam DALLI

Proposal for a regulation
Article 13 – paragraph 1 – introductory part

1. By way of derogation from paragraph -1 and from point (a) of Article 5(3) of Directive 1999/31/EC, mercury waste may be ~~stored in one of the following ways:~~ temporarily stored in liquid form for up to five years subject to the specific requirements for the temporary storage of mercury waste, as laid down in Annexes I, II and III to that Directive, in above-ground facilities dedicated to and equipped for the temporary storage of mercury.

Amendment 253 #

Proposal for a regulation
Article 13 – paragraph 1 – introductory part

1. By way of derogation from point (a) of Article 5(3) of Directive 1999/31/EC, mercury waste may be stored temporarily, for a maximum period of 10 years in accordance with the specific requirements for the temporary storage of mercury waste as laid down in Annexes I, II and II to that Directive, in one of the following ways:

Amendment 254 #

Proposal for a regulation
Article 13 – paragraph 1 – introductory part

1. By way of derogation from point (a) of Article 5(3) of Directive 1999/31/EC, mercury waste may be ~~stored in one of the following ways:~~ temporarily stored for a period not exceeding five years in above-ground facilities dedicated to and equipped for the temporary storage of mercury awaiting solidification prior to final disposal.

Amendment 255 #

Proposal for a regulation
Article 13 – paragraph 1 – introductory part

1. By way of derogation from point (a) of Article 5(3) of Directive 1999/31/EC, mercury waste may be stored ~~in one of the following ways:~~temporarily for up to five years in above- ground facilities dedicated to and equipped for the temporary storage of mercury.

Amendment 256 #

Albert DESS

Proposal for a regulation
Article 13 – paragraph 1 – introductory part

(1) By way of derogation from point (a) of Article 5(3) of Directive 1999/31/EC and accompanied by a plan for the permanent storage of waste in solidified form, together with a timeframe, mercury waste may be stored in one of the following ways:

Amendment 257 #