COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury as regards dental amalgam and other mercury-added products subject to manufacturing, import and export restrictions
Date: 2023-07-14
Institutions: Directorate-General for Environment, European Commission
Subjects: EU production, dental medicine, environmental protection, export restriction, import restriction, lighting equipment, market approval, mercury, metal pollution

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  EN 

   EUROPEAN COMMISSION  Brussels, 14.7.2023  SWD(2023) 397 final  COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury as regards dental amalgam and other mercury-added products subject to manufacturing, import and export restrictions {COM(2023) 395 final} - {SEC(2023) 395 final} - {SWD(2023) 395 final} - {SWD(2023) 396 final}  
 
 
Subsidiarity Grid 

1.  Can the Union act? What is the legal basis and competence of the Unions’ intended action? 

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy initiative? 

The  legal  basis  for  this  proposal  is  Article  192  TFEU.  In  accordance  with  Article  192(1) 
TFEU,  the  European  Union  shall  contribute  to  the  pursuit,  inter  alia,  of  the  following 
objectives:  preserving,  protecting  and  improving  the  quality  of  the  environment;  promoting 
measures  at  international  level  to  deal  with  regional  or  worldwide  environmental  problems, 
and combating climate change. 

1.2 Is the Union competence represented by this Treaty article exclusive, shared or supporting in 
nature? 

In the case of environment, the Union’s competence is shared, in accordance with Article 4 of 
the TFEU. 

2.  Subsidiarity Principle: Why should the EU act? 

2.1  Does the proposal fulfil the procedural requirements of Protocol No. 21: 

The Commission’s proposal to revise Regulation (EU) 2017/852 on mercury is supported by 
an  impact  assessment  prepared  in  accordance  with  the  Commission’s  prevailing  guidelines 
and  reviewed  by  the  independent  Regulatory  Scrutiny  Board.  The  impact  assessment 
addresses the issues  of subsidiarity and proportionality, economic, social  and environmental 
impacts and documents the extensive consultation activities undertaken. 

The  consultation  process  included  a  variety  of  different  consultation  activities  aimed  at 
gathering the views of all stakeholders and ensuring that the view of different organisations 
and stakeholder types were presented and considered. 

-  Feedback  was  invited  on  the  Inception  Impact  Assessment  published  via  the 
Commission’s ‘Have Your Say’ interactive portal. This was followed by a web-based 
Public Consultation open to all. The survey contained 66 questions, covering the three 
areas  of  interest  (dental  amalgam,  mercury  emissions  from  crematoria  and  mercury-
added products). 

-  A targeted stakeholder survey (TSS) took place from  15 December 2021 to 15 April 
2022  which  contained  specialised  questions  in  the  above-mentioned  three  areas  of 
interest.  

-  Follow-up  interviews,  two  consultation  workshops  and  a  focus  group,  to  engage 

stakeholders in deeper discussion on key themes.  

-  The TSS included consultation of national, regional and local stakeholders specifically 
regarding crematoria as this sector has in the past been largely publicly-run. As this is 
changing  and  more  private  companies  are  managing  crematoria,  both  public  and 
private operators of crematoria were consulted. 

In  line  with  the  Commission’s  commitment  to  better  regulation,  this  proposal  has  been 
prepared 
transparency  and  continuous  engagement  with 
stakeholders  with  due  regard  to  avoiding  unnecessary  burdens.  It  is  based  on  the  best 

inclusively,  based  on  full 

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  

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available  evidence,  referenced  in  the  Impact  Assessment  accompanying  this  proposal,  and 
expert knowledge taking into account the external feedback.  

The  proposal  respects  fundamental  rights,  in  particular  those  in  the  Charter  of  Fundamental 
Rights of the European Union. It also contributes to the right to a high level of environmental 
protection in line with the principle of sustainable development, as laid down in Article 37 of 
the Charter. 

2.2  Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the conformity with the 
principle of subsidiarity? 

The explanatory memorandum accompanying the Commission’s proposal presents a summary 
of  the  Commission’s  analysis  included  in  its  impact  assessment  and  covering  elements  on 
subsidiarity and proportionality.  

Mercury is  a pollutant  which can travel  long distances in  the  atmosphere once released  and 
collective (global) action is needed to address its release and control and so Union action is 
justified to achieve a high level of environmental and human health protection. 

The 2020 Review Report (COM2020/378) concluded on the necessity of EU action to, inter 
alia,  establish  a  complete  EU  phase-out  of  the  use  of  dental  amalgam  and  to  align  Union 
legislation  on  products  containing  mercury  (MAPs),  as  it  would  ensure  more  effective  and 
efficient implementation than what could be achieved at the Member States’ level.  

2.3  Based on the answers to the questions below, can the objectives of the proposed action be 

achieved sufficiently by the Member States acting alone (necessity for EU action)? 

The objectives of the proposed action cannot be achieved sufficiently by the Member States 
acting alone. 

(a)  Are there significant/appreciable transnational/cross-border aspects to the problems being 

tackled? Have these been quantified? 

Mercury pollution is transboundary, travelling across national borders, both between Member 
States  and  across  the  frontiers  of  the  EU.  Hence  appropriate  and  effective  pollution  control 
can  be  achieved  more  quickly  and  efficiently  at  Union  level  compared  to  Member  States 
acting alone in an uncoordinated manner.  

(b)  Would national action or the absence of the EU level action conflict with core objectives of 

the Treaty2 or significantly damage the interests of other Member States? 

In the absence of a common EU approach for restricting the last remaining intentional uses of 
mercury phasing out, specifically the use of dental amalgam and prohibiting the manufacture 
and  export  of  mercury-containing  lamps,  risks  impeding  the  Union’s  effort  in  pursuing  the 
objective  set  out  in  Flagship  8  of  the  Zero  Pollution  Action  Plan  i.e.,  minimising  the  EU’s 
pollution footprint. Non-action would also risk hindering the Treaty objectives of achieving a 
high level of environmental and human health protection. 

(c)  To what extent do Member States have the ability or possibility to enact appropriate 

measures? 

2 https://europa.eu/european-union/about-eu/eu-in-brief_en  

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The provisions of the  Regulation will be directly  applicable in  the Member States.  Member 
States take appropriate national administrative and legal measures to implement and enforce 
these EU provisions. 

(d)  How does the problem and its causes (e.g. negative externalities, spill-over effects) vary 

across the national, regional and local levels of the EU? 

The impact assessment documents the status of the progress achieved by individual Member 
States  in  tackling mercury  emissions from  the  last  remaining  intentional  uses of mercury in 
the  EU  (the  use  of  dental  amalgam  and  the  manufacture  and  export  of  mercury-containing 
lamps). However, progress is heterogeneous in phasing out completely the use of mercury in 
dental  amalgam  and  other  products,  despite  mercury-free  alternatives  being  available  and 
accessible. 

(e)  Is the problem widespread across the EU or limited to a few Member States? 

Although mercury pollution is a problem widespread across the EU due to its transboundary 
nature, national differences are observed in the use of dental amalgam for dental treatments, 
mercury emissions from crematoria and the manufacture of mercury-containing lamps.  

(f)  Are Member States overstretched in achieving the objectives of the planned measure? 

Regulation  (EU)  2017/852  on  mercury  is  the  main  EU  instrument  regulating  mercury  and 
covers  the  entire  lifecycle  of  mercury  from  mining  to  final  disposal.  The  Regulation  was 
adopted  in  2016  and  is  based  on  a  Commission  proposal  repealing  Regulation  (EC)  No 
1102/2008. The Mercury Regulation entered into force on 13 June 2017. This means that the 
EU  legislative  framework  on  mercury  is  already  well  embedded  in  the  national  legislative 
frameworks of Member  States, not  least  because of their  commitments under  the  Minamata 
Convention, to which they are Parties. Therefore. the current revision builds on the ongoing 
phase-out of mercury. 

(g)  How do the views/preferred courses of action of national, regional and local authorities differ 

across the EU? 

Considering the toxicity  of mercury and the harmful impacts  it has on the environment  and 
human health, there is  a widespread view at national, regional and local  levels that a robust 
and  comprehensive  EU  legislative  framework  is  necessary  to  eliminate  or  reduce  those 
negative impacts; and that further improvements are required to make it fully consistent with 
objectives  set  out  under  the  European  Green  Deal  (COM/2019/640),  the  Zero  Pollution 
Ambition  Flagship  8  of  minimising  the  EU’s  pollution  footprint  and  the  Sustainable 
Chemicals Strategy. 

2.4  Based on the answer to the questions below, can the objectives of the proposed action be 

better achieved at Union level by reason of scale or effects of that action (EU added value)? 

The  objectives  of  the  proposed  action  can  be  better  achieved  at  Union  level  by  reasons  of 
scale and uniformity of that action. 

(a)  Are there clear benefits from EU level action?  

Concerning  the  use  of  dental  amalgam,  EU  level  action  through  a  complete  phase-out 
provides for a more consistent/comprehensive tool to eliminate the last remaining intentional 
uses  of  mercury,  the  negative  impacts  of  mercury  emissions,  including  transboundary 

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emissions.  Furthermore,  an  ambitious  phase-out  date  (2025)  will  lead  to  more  omitted 
mercury pollution and reduced potential risk. 

Regarding  mercury-added  products,  action  at  Union  level  will  allow  establishing  a  more 
consistent  and  clearer  legal  framework  by  addressing  all  sides  of  the  issue  from 
manufacturing to export. Clear and precise EU-wide rules will enable concerned individuals 
and legal persons to ascertain the full extent of their rights and obligations. 

The EU legal framework is increasingly being used by third countries, thereby also promoting 
an international level playing field. 

(b)  Are there economies of scale? Can the objectives be met more efficiently at EU level (larger 

benefits per unit cost)? Will the functioning of the internal market be improved? 

Uniform  action  to  phase  out  the  use  of  dental  amalgam  and  other  mercury-added  products, 
specifically  mercury-containing  lamps,  will  reduce  the  potential  risk  of  mercury  pollution 
across and beyond the EU; lead to a more efficient functioning of the EU market for mercury-
added  products  as  well  as  more  effective  compliance/enforcement  across  the  EU. 
Furthermore,  uniform  action  is  necessary  in  order  to  align  the  Mercury  Regulation  with 
already  existing  legislative  framework  e.g.,  the  Directive  on  the  Restriction  of  Hazardous 
Substances in Electrical and Electronic Equipment (RoHS). 

Overall, the proposal strengthens the existing mercury legislative framework that equips the 
EU  to  address  the  significant  environmental  challenges  expected  in  the  next  decade  from 
intentional mercury uses. 

(c)  What are the benefits in replacing different national policies and rules with a more 

homogenous policy approach? 

The  current  Mercury  Regulation  needs  to  be  adapted,  in  line  with  Article  19,  to  more 
comprehensively  integrate  the  objectives  set  out  in  the  Zero  Pollution  Ambition  and 
Sustainable  Chemicals  Strategy.  The  Commission’s  proposal  to  review  the  Mercury 
Regulation aims to address the last remaining intentional uses of mercury, taking into account 
the availability and accessibility of mercury-free alternatives. Furthermore, uniform action to 
phase  out  the  use  of  dental  amalgam  and  other  mercury-added  products  will  reduce  the 
potential risk of mercury pollution and lead to a more efficient functioning of the EU market 
for such products as well as more effective compliance/enforcement across the EU. 

This initiative will contribute to overall pollution reductions both within and outside the EU, 
delivering healthier ecosystems and improved human health. In parallel, this will support EU 
companies in becoming first movers and developing more mercury-free alternatives.  

(d)  Do the benefits of EU-level action outweigh the loss of competence of the Member States and 
the local and regional authorities (beyond the costs and benefits of acting at national, regional 
and local levels)? 

A loss of competence of Member States is limited as this proposal strengthens and improves 
an  already  existing  legislative  framework  aiming  at  further  alignment  with  other  EU 
legislation  e.g.,  the  Directive  on  the  Restriction  of  Hazardous  Substances  in  Electrical  and 
Electronic Equipment (RoHS). Overall, benefits of the initiative outweigh any such possible 
loss of competence of Member States and local and regional authorities. 

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(e)  Will there be improved legal clarity for those having to implement the legislation? 

Yes, as the proposal will allow establishing a more consistent and clearer legal framework by 
addressing  all  sides  of  the  issue  from  manufacturing  to  export.  Clear  and  precise  EU-wide 
rules will enable concerned individuals and legal persons to ascertain the full extent of their 
rights and obligations. 

3.  Proportionality: How the EU should act 

3.1  Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the proportionality of 
the proposal and a statement allowing appraisal of the compliance of the proposal with the 
principle of proportionality? 

The explanatory memorandum summarises the analysis of the supporting impact assessment 
which  contains  an  environmental,  economic  and  social  assessment  of  each  policy  option 
including an assessment of proportionality. The content of this proposal takes full account of 
the outcome of this analysis.  

The  proposed  phase-out  of  the  use,  manufacture  and  export  of  dental  amalgam  and  the 
proposed  prohibition  on  the  manufacture,  import  and  export  of  relevant  mercury-containing 
lamps  are  deemed  to  be  proportionate  and  timely.  By  providing  for  the  above-mentioned 
phase-out and prohibition, this proposal does not go beyond what is necessary to achieve the 
environmental  objective  being  pursued,  i.e.,  a  mercury-free  Europe,  which  will  no  longer 
export mercury-added products for which toxic-free and more energy-efficient alternatives are 
available.  

The  option  of  a  legally  binding  obligation  for  Member  States  to  install  best  available 
technologies  for  the  abatement  of  mercury  emissions  in  crematoria  was  not  chosen  for  the 
reasons of proportionality.  

3.2  Based on the answers to the questions below and information available from any impact 
assessment, the explanatory memorandum or other sources, is the proposed action an 
appropriate way to achieve the intended objectives? 

The proposed action constitutes an appropriate way to achieve the intended objectives. 

(a)  Is the initiative limited to those aspects that Member States cannot achieve satisfactorily on 

their own, and where the Union can do better? 

The  initiative  is  limited to  those  aspects  that  Member  State  cannot  achieve  satisfactorily  on 
their own, and where the Union can do better.  

(b)  Is the form of Union action (choice of instrument) justified, as simple as possible, and 

coherent with the satisfactory achievement of, and ensuring compliance with the objectives 
pursued (e.g. choice between regulation, (framework) directive, recommendation, or 
alternative regulatory methods such as co-legislation, etc.)? 

The objectives of this proposal can be best pursued through a Regulation, which is the most 
appropriate  instrument  to  amend  an  existing  Regulation.  It  is  as  simple  as  possible,  and 
coherent  with  the  satisfactory  achievement  of,  and  ensuring  compliance  with  the  objectives 
pursued. 

A  Regulation  is  a  legal  act  that  applies  directly  and  uniformly  to  all  EU  Member  States  as 

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soon as it enters into force. Member States do not need to create their own legislation to bring 
this legal act into force.  

(c)  Does the Union action leave as much scope for national decision as possible while achieving 

satisfactorily the objectives set? (e.g. is it possible to limit the European action to minimum 
standards or use a less stringent policy instrument or approach?) 

The  legal  basis  for  this  proposal  is  Article  192  TFEU.  In  accordance  with  Article  192(1) 
TFEU,  the  European  Union  shall  contribute  to  the  pursuit,  inter  alia,  of  the  following 
objectives:  preserving,  protecting  and  improving  the  quality  of  the  environment;  promoting 
measures  at  international  level  to  deal  with  regional  or  worldwide  environmental  problems, 
and combating climate change. 

Furthermore, Article 19(3) of the Mercury Regulation stipulates that the Commission shall, if 
appropriate, present a legislative proposal together with its report referred to in Article 19(1). 
However,  action  taken  at  EU  level  concerning  mercury  emissions  from  crematoria  raised 
issues  around  proportionality.  Hence,  the  development  of  non-binding  EU  guidance  would 
allow Member States to implement control measures on a voluntary basis and at the discretion 
of national or regional authorities. 

(d)  Does the initiative create financial or administrative cost for the Union, national governments, 
regional or local authorities, economic operators or citizens? Are these costs commensurate 
with the objective to be achieved? 

The initiative creates costs that are provided in the answer to question 3.1 above, which also 
shows that these costs are proportionate. 

(e)  While respecting the Union law, have special circumstances applying in individual Member 

States been taken into account? 

The proposal  contains  a  provision  on  a  derogation, enabling under  certain conditions and at 
the  discretion  of  medical  practitioners  taking  into  account  of  special  circumstances,  while 
respecting the Union law. 

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