Proposal for a COUNCIL DECISION on the position to be taken on behalf of the European Union at the third meeting of the Conference of the Parties to the Minamata Convention on Mercury as regards the adoption of a Decision on the phasing-out of dental amalgam and amending Annex A to this Convention
Date: 2019-09-16
Institutions: Directorate-General for Environment, European Commission
Subjects: dental medicine, environmental protection, international convention, mercury, metal pollution, prevention of pollution, public health, revision of an agreement

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   EUROPEAN COMMISSION  Brussels, 16.9.2019  COM(2019) 414 final 2019/0194 (NLE)  Proposal for a COUNCIL DECISION on the position to be taken on behalf of the European Union at the third meeting of the Conference of the Parties to the Minamata Convention on Mercury as regards the adoption of a Decision on the phasing-out of dental amalgam and amending Annex A to this Convention  
 
EXPLANATORY MEMORANDUM 

1. 

SUBJECT MATTER OF THE PROPOSAL 

This  proposal  concerns  the  decision  establishing  the  position  to  be  taken,  on  the  Union's 
behalf, at the third meeting of the Conference of the Parties to the Minamata Convention on 
Mercury in connection with the envisaged adoption of a Decision on the phasing-out of dental 
amalgam and amending Annex A to that Convention.  

2. 

CONTEXT OF THE PROPOSAL 

2.1. 

The Minamata Convention on Mercury 

The  Minamata  Convention  on  Mercury  ('the  Agreement’)  is  the  main  international  legal 
framework  aimed  at  protecting  human  health  and  the  environment  from  anthropogenic 
emissions and releases of mercury and mercury compounds to air, water and land.  

It addresses the whole life-cycle of mercury, from primary mercury mining to mercury waste 
disposal, including the interim storage of mercury, mixtures of mercury with other substances, 
including  alloys  of  mercury,  with  a  mercury  concentration  of  at  least  95%  per  weight 
('mercury mixtures'), and of six mercury compounds, including mercury (I) chloride, mercury 
(II)  oxide,  mercury  (II)  sulphate,  mercury  (II)  nitrate,  cinnabar  and  mercury  sulphide,  other 
than  waste  mercury.  The  Agreement  entered  into  force  on  16  August  2017.  The  European 
Union is a Party to the Agreement1 as well as most Member States2. 

2.2. 

The Conference of the Parties   

The Conference of the Parties to the Agreement ('COP') performs the functions assigned to it 
by  the  Agreement  and,  to  that  end,  shall  consider  and  undertake  inter  alia  any  additional 
action that may be required for the achievement of the objectives of the Agreement, including 
the adoption of relevant guidelines. 

According  to  Article  28  of  the  Agreement  and  Decision  MC-1/1  on  Rules  of  Procedures 
adopted  by  the  COP  at  its  first  meeting  (24-29  September  2017),  each  Party  has  one  vote. 
However,  the  Union,  as  a  regional  economic  integration  organisation,  exercises  its  right  to 
vote,  on  matters  within  its  competence,  with  a  number  of  votes  equal  to  the  number  of  its 
Member States that are Parties to the Agreement. The Union shall not exercise its right to vote 
if any of its Member States exercises its right to vote, and vice versa.  

2.3. 

The envisaged act of the Conference of the Parties  

Based  on  information  made  available  to  Parties  of  the  Agreement,  the  COP  is  expected  to 
adopt on 25 November 2019, during its third meeting, a Decision regarding the phasing-out of 
dental amalgam and the amendment of Annex A to the Convention as a follow-up to a joined 
proposal  made  by  six  African  countries  which  are  Parties  to  the  Agreement  (Gabon,  Chad, 
Guinea  Bissau,  Botswana,  Senegal,  Niger),  in  accordance  with  Articles  26  and  27  of  the 
Agreement (‘the envisaged act’).  

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Council Decision (EU) 2017/939 of 11 May 2017 on the conclusion on behalf of the European Union of 
the Minamata Convention on Mercury (OJ L 142, 2.6.2017, p. 4).  
On 20 June 2019, twenty-three Member States had ratified the Minamata Convention on Mercury, i.e. 
Austria,  Belgium,  Bulgaria,  Croatia,  Czech  Republic,  Denmark,  Estonia,  Finland,  France,  Germany, 
Hungary,  Ireland,  Latvia,  Lithuania,  Luxembourg,  Malta,  Netherlands,  Portugal,  Romania,  Slovakia, 
Slovenia, Sweden and the United Kingdom. 

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Part  I  of  Annex  A  to  the  Agreement  contains  a  list  of  mercury-added  products  (e.g.  certain 
compact  fluorescent  lamps  for  general  lighting  purposes),  the  manufacturing,  import  and 
export  of  which  is  prohibited  as  from  2021,  in  accordance  with  Article  4(1)  of  this 
Agreement. 

Part II of Annex A to the Agreement contains a list of nine measures on the phasing-down of 
the  use  of  dental  amalgam.  In  accordance  with  Article  4(1)  and  Part  II  Annex  A  to  the 
Agreement, Parties must take at least two measures (e.g. to restrict the use of dental amalgam 
to its encapsulated form).       

The objective of the envisaged act is to  phase-out the use of dental amalgam. To do so, the 
envisaged  act  proposes  to  regulate  the  manufacture  of  and  the  international  trade  in  dental 
amalgam  in  two  steps.  Firstly,  it  provides  for  the  phasing-out,  as  from  2022,  of  the 
manufacture, import and export of dental amalgam when destined to be used for the treatment 
of  deciduous  teeth,  as  well  as  of  teeth  of  children  under  the  age  of  15  and  of  pregnant  and 
breastfeeding  women.  Secondly,  it  foresees  to  apply  this  prohibition  as  from  2025  to  the 
manufacture,  import  and  export  of  dental  amalgam  for  all  other  uses,  except  where  no 
mercury-free  alternatives  are  available.  In  this  respect,  the  envisaged  act  proposes  to  delete 
Part  II of Annex A to  the Agreement and to  include dental amalgam  in  the list  of mercury-
added products referred to in Part I of Annex A to the Agreement.  

3. 

POSITION TO BE TAKEN ON THE UNION'S BEHALF 

The proposed position to be taken on the Union's behalf is to support, at the third meeting of 
the COP, the adoption of a Decision that is consistent with the EU acquis.  

Article 10(2)  of Regulation 2017/852/EU of the European Parliament  and of the Council of  
17 May 2017 on Mercury3 (‘Regulation 2017/852/EU’) prohibits, as from 1 July 2018, the use 
of dental amalgam in the EU for the treatment of deciduous teeth, as well as of the teeth of 
children under the age of 15 and of pregnant and breastfeeding women.  

Article 19 of Regulation 2017/852/EU foresees inter alia that the Commission will report to 
the European Parliament and to the Council, by 30 June 2020, on the feasibility of a phase-out 
in the EU of the use of dental amalgam in the long term, and preferably by 2030, whilst taking 
into  account  the  Member  States’  national  plans  on  the  phasing  down  of  the  use  of  dental 
amalgam  referred  to  in  Article  10(3)  and  fully  respecting  their  national  competence  for  the 
organisation and delivery  of health services and  medical  care.  In light  of this, the European 
Commission  has  launched  in  September  2018  an  assessment  on  the  feasibility  of  such  a 
phasing-out  in  the  EU  by  2030.  The  study  outcome  will  contain  a  technical  assessment, 
including  the  analysis  of  above-mentioned  national  plans,  which  all  Member  States  had  to 
submit by 1 July 2019. This study will conclude in February 2020 and will inform the above-
mentioned Commission’s report due by end June 2020.           

Hence,  the  EU  acquis  regulates  the  use  dental  amalgam  but  does  not  currently  prevent  its 
manufacture,  import  and  export.  In  the  future,  consideration  may  be  given  to  the  option  of 
widening the restrictions on use to include a ban on manufacture, import and export of dental 
amalgam  depending  inter  alia  on  the  outcome  of  the  review  of  Regulation  2017/852/EU  in 
accordance with Article 19.    

3 

OJ L 137, 24.5.2017, p.1.  

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Accordingly, at the third meeting of the Conference of the Parties to the Agreement, the EU 
can only support the adoption of a Decision that  is consistent with the EU  acquis. A Union 
position is needed as, once adopted, the Parties to the Agreement will have to implement the 
envisaged act. 

4. 

LEGAL BASIS 

4.1. 

Procedural legal basis 

4.1.1.  Principles 

Article 218(9) of the Treaty on the Functioning of the European Union (TFEU) provides for 
decisions establishing ‘the positions to be adopted on the Union’s behalf in a body set up by 
an  agreement,  when  that  body  is  called  upon  to  adopt  acts  having  legal  effects,  with  the 
exception of acts supplementing or amending the institutional framework of the agreement.’ 
The concept of ‘acts having legal effects’ includes acts that have legal effects by virtue of the 
rules of international law governing the body in question. It also includes instruments that do 
not  have  a  binding  effect  under  international  law,  but  that  are  ‘capable  of  decisively 
influencing the content of the legislation adopted by the EU legislature’4. 

4.1.2.  Application to the present case 

The COP is a body set up by an agreement, namely the Minamata Convention on Mercury. 

The  envisaged  act,  which  the  COP  is  called  upon  to  adopt,  constitutes  an  act  having  legal 
effects.  The  envisaged  act  has  legal  effects  because  Parties  to  the  Agreement  shall  take 
measures to ensure that it is implemented and complied with. 

The  envisaged  act  does  not  supplement  or  amend  the  institutional  framework  of  the 
Agreement. Therefore, the procedural legal basis for the proposed decision is Article 218(9) 
TFEU. 

4.2. 

Substantive legal basis 

4.2.1.  Principles 

The  substantive  legal  basis  for  a  decision  under  Article  218(9)  TFEU  depends  primarily  on 
the objective and content of the envisaged act in respect of which a position is taken on the 
Union's behalf.  If the  envisaged act  pursues two  aims or has two components  and if one of 
those  aims  or  components  is  identifiable  as  the  main  one,  whereas  the  other  is  merely 
incidental, the decision under Article 218(9) TFEU must be founded on a single substantive 
legal basis, namely that required by the main or predominant aim or component. 

4.2.2.  Application to the present case 

The  main  objective  and  content  of  the  envisaged  act  relate  to  environment.  Therefore,  the 
substantive legal basis of the proposed decision is Article 192(1) TFEU. 

4.3. 

Conclusion 

The legal basis of the proposed decision should be Article 192(1) TFEU, in conjunction with 
Article 218(9) TFEU. 

4 

Judgment  of  the  Court  of  Justice  of  7  October  2014,  Germany  v  Council,  C-399/12,  ECLI: 
EU:C:2014:2258, paragraphs 61 to 64.  

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2019/0194 (NLE) 

Proposal for a 

COUNCIL DECISION 

on the position to be taken on behalf of the European Union at the third meeting of the 
Conference of the Parties to the Minamata Convention on Mercury as regards the 
adoption of a Decision on the phasing-out of dental amalgam and amending Annex A to 
this Convention 

THE COUNCIL OF THE EUROPEAN UNION 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 192(1), in conjunction with Article 218(9) thereof, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

The  Minamata  Convention  on  Mercury5  (‘the  Agreement’)  was  concluded  by  the 
Union by Council Decision (EU) 2017/9396 and entered into force on 16 August 2017.  

Pursuant  to  Decision  MC-1/1  on  Rules  of  Procedures  adopted  by  the  Conference  of 
the Parties to the Agreement at its first meeting, the Parties shall make every effort to 
reach agreement on all matters of substance by consensus.  

The  Conference  of  the  Parties  to  the  Agreement,  during  its  third  meeting  on  25-29 
November  2019,  is  expected  to  adopt  a  Decision  (‘the  proposed  Decision’)  on  the 
phasing-out of dental amalgam and amending Annex A to the Agreement.  

It  is  appropriate  to  establish  the  position  to  be  taken  on  the  Union's  behalf  in  the 
Conference  of  the  Parties  to  the  Agreement,  as  this  proposed  Decision,  if  approved,   
will have legal effects since the Parties to the Agreement will have to take measures to 
implement it at national and/or regional levels.  

The  proposed  Decision  foresees  a  prohibition  as  from  2022  on  the  manufacture, 
import and export of dental amalgam when used for treatment of deciduous teeth and 
of teeth of children under the age of fifteen and of pregnant and breastfeeding women. 
The  proposed  Decision  envisages  extending  such  prohibition,  as  from  2025,  to  the 
manufacture, import and export of dental amalgam for all other uses, except where no 
mercury-free  alternatives  are  available.  The  proposed  Decision  provides  for  the 
amendment of Annex A to the Agreement as a means to implement those prohibitions 
in the Agreement.      

(6) 

Article  10(2)  of  Regulation  2017/852/EU  of  the  European  Parliament  and  of  the 
Council on Mercury7 prohibits as from 1 July 2018 the use of dental amalgam in the 

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Certified 
https://treaties.un.org/doc/Treaties/2013/10/20131010%2011-16%20AM/CTC-XXVII-17.pdf 
Council Decision (EU) 2017/939 of 11 May 2017 on the conclusion on behalf of the European Union of 
the Minamata Convention on Mercury (OJ L 142, 2.6.2017, p. 4).  

the  Minamata 

on  Mercury 

Convention 

available 

at: 

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Union for the treatment  of  deciduous teeth  and of teeth  of children under the age of 
fifteen  and  of  pregnant  and  breastfeeding  women;  whereas  Article  19  of  that 
Regulation provides that the Commission will assess and report by 30 June 2020 to the 
European Parliament and to the Council on the feasibility of a phase-out in the Union 
of the use of dental amalgam in the long term, and preferably by 2030. 

(7) 

The proposed Decision should accordingly only be supported as far as its elements on 
the phasing-out of the use of dental amalgam for the treatment of deciduous teeth and 
of teeth of children under the age of fifteen and of pregnant and breastfeeding women 
are concerned; whereas the Union should only support the adoption of a Decision by 
the  Conference  of  the  Parties  to  the  Agreement  that  is  consistent  with  the  Union 
acquis. 

HAS ADOPTED THIS DECISION: 

The position to be taken on the Union's behalf in the third meeting of the Conference of the 
Parties to the Agreement shall be to support the adoption of a Decision on the phasing-out of 
the use of dental amalgam that is consistent with the Union acquis. 

Article 1 

This Decision is addressed to the Commission. 

Article 2 

Done at Brussels, 

For the Council 
The President 

7 

Regulation 2017/852/EU of the European Parliament and of the Council of  17 May 2017 on Mercury, 
and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p.1). 

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