COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT 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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   EUROPEAN COMMISSION  Brussels, 14.7.2023  SWD(2023) 395 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  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) 396 final} - {SWD(2023) 397 final}  
 
 
EXECUTIVE SUMMARY 

Policy context 

Mercury  is  a  hazardous  substance  which  poses  a  threat  to  the  environment  and  to  human 
health.  Following  signature  of  the  Minamata  Convention  on  Mercury  in  2013,  the  EU 
established Regulation (EU) 2017/852 on Mercury, setting limits on the use of mercury in a 
range of products and prohibiting the export of metallic mercury from the EU. Article 19(1) 
of the Regulation required the Commission to report on the outcome of its review for three 
focal areas: 

  Feasibility of a phase out of the use of dental amalgam, preferably by 2030; 

  Emissions of mercury and mercury compounds from crematoria; and 

  Environmental  benefits  and  feasibility  of  a  further  alignment  of  Annex  II  with 
relevant  Union  legislation  regulating  the  placing  on  the  market  of  mercury-added 
products (MAPs). 

This report concluded that the phase out of dental amalgam is technically and economically 
feasible  before  2030  and  that  the  evidence  base  for  mercury  emissions  from  crematoria  is 
highly uncertain, requiring further work. It also called for further work to assess the need to 
prohibit the placing on the market, manufacture and export of certain MAPs. This study will 
support  the  Commission  in  further  assessment  of  these  problem  areas,  with  the  aim  of 
supporting  a revision of  the Regulation.  This  work and any subsequent  legislative proposal 
will contribute to the Zero pollution ambition for a toxic-free environment announced in the 
European  Green  Deal  (EGD),  the  Zero  Pollution  Action  Plan  (ZPAP)  and  the  Chemicals 
Strategy for Sustainability (CSS).  

Aims and objectives of the study 

The  overall  aim  of  this  study  was  to  investigate  the  three  Article  19(1)  problem  areas  in 
further detail to support a revision of Regulation (EU) 2017/852 on Mercury. This will close 
remaining gaps in EU legislation, to contribute to the objectives of the Minimata Convention 
and the EGD. The specific policy objectives for each of the three problem areas are: 

Problem 1 – To assess if and when a dental amalgam phase-out could be achieved 
(earlier than 2030), building on the commitment made in Article 10 of the 
Regulation (EU) 2017/852 on Mercury to phasing down dental amalgam use. 

Problem 2 – To reduce emissions from crematoria to levels not considered significant 
to human health and the environment, in line with ambition to create a toxic-free 
environment as set in the ZPAP. 

Problem 3 – To reduce entry into circulation of mercury in society by cutting supply 

and demand of mercury in products for all supply chains originating in the EU. This 
is in line with the ZPAP and CSS commitment to reduce the EU’s external pollution 
footprint and restricting exports of products not allowed in the EU market. 

Approach 

In order to  further assess  these three areas, the problem  was defined  (including key drivers 
and  impacts),  data  sources  were  identified  and  the  policy  objectives  were  defined  for  each 
problem area. A baseline was then developed for each problem area, forming the benchmark 
by which the policy options will be compared against and outlining what would happen under 

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a  ‘no  change’  scenario.  A  long  list  of  policy  measures  was  identified  based  on  the  Article 
19(1) Review Report and input from Member States and stakeholders. These measures were 
then screened, with  selected measures  retained and the economic, social  and environmental 
impacts  were  assessed  in  comparison  to  the  baseline,  in  line  with  the  Better  Regulation 
Guidelines.  Six  policy  options  were  retained  (with  sub-options)  which  were  then  compared 
and a preferred policy package was identified. An overarching componment of the study was 
an depth programme of stakeholder consultation. The consultation strategy included an open 
public  consultation,  a  targeted  consultation  survey,  targeted  interviews,  a  focus  group  and 
two consultation workshops. 

Problem definition 

Problem 1 – Dental Amalgam 

Dental  amalgam  is  used  as  a  filling  material  to  restore  tooth  surfaces  and  is  the  largest 
remaining  intentional  use  of  mercury  in  the  EU.  Use  of  dental  amalgam  can  result  in 
emissions  of  mercury,  during  placement/removal  by  dental  practitioners,  via  excretion  or 
through cremation or burial of people with dental amalgam restorations. These emissions in 
turn  lead  to  adverse  human  health  effects.  Limited  exposure  may  also  occur  during  the 
lifetime of a restoration. Use of dental amalgam varies considerably across Members States, 
for example Sweden has completely phased out dental amalgam use, but eight Member States 
used dental amalgam for over 50% of restorations in 2019. Its continued use can be motivated 
by  a  lack  of  communication/awareness  of  mercury-free  alternatives,  lack  of  training  of 
practitioners  to  use  such  alternatives  and  in  some  cases  higher  costs  for  reimbursement  of 
mercury-free alternatives.  

Problem 2 – Mercury emissions from crematoria 

Crematoria continue to  be an important source of mercury emissions in the EU, originating 
from mercury amalgam fillings in human remains. The number and size of crematoria in the 
EU  vary  significantly  by  Member  State,  for  example  Spain  has  the  highest  number  of 
crematoria in the EU but most carry out less than 350 cremations a year, whereas in Croatia 
the  average  crematorium  carries  out  5000  cremations  a  year.  A  38%  increase  in  annual 
cremation  numbers  were  experienced  in  the  EU  between  2010  and  2019,  and  cremation  is 
estimated  to  continue  to  increase  across  the  EU  up  to  2030.  Emissions  of  mercury  from 
crematoria can be avoided through the use of abatement  techniques. There are currently no 
EU-wide regulations on the use of such techniques, although use is expected to increase and 
abatement techniques are recommended by OSPAR and HELCOM Commissions. As dental 
amalgam  fillings last on average 15-20  years, emissions  from  crematoria will still continue 
even after a phase out of dental amalgam.  

Problem 3 – Manufacture of mercury-added products for export to third countries 

Various  laws  are  in  place  to  prohibit  the  placing  on  the  market  and  import  into  the  EU  of 
MAPs, however, there are MAPs which continue to be manufactured in the EU and exported 
to third countries despite being prohibited for placing on the EU market. This is a significant 
cause  of  mercury  pollution  in  third  countries,  where  EU-made  products  add  to  the  national 
burden of hazardous products. In many cases, MAPs can end up in landfill or are incinerated 
in some cases. This weakens the position of the EU as a global leader and threatens its ability 
to meet its objectives of reducing the EU’s external pollution footprint. The relevant MAPs 
considered in this study include dental amalgam and various types of lamps, which are either 

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currently or soon to  be  banned on the internal  market  but  continue to  be manufactured and 
exported. 

Policy options 

A  longlist  of  potential  measures  was  identified  based  on  the  Commission  Article  19(1) 
Review Report and input from  Member States and stakeholders. These measures were then 
screened, in line with Better Regulation Tool #16, to identify those which should be analysed 
further, and the remaining thirteen measures were then retained for further analysis (three for 
dental amalgam, six for crematoria, four for MAPs). These measures were assessed for their 
impacts, and six policy options were retained. The retained policy options for each problem 
are laid out below: 

The table below lists the shortlisted policy options.  

Policy Option 

PO1 – Dental health communication campaigns 

PO2 – Establish a legally binding end date for the use of dental amalgam in the EU 

PO3 – Publication of EU guidance on emissions abatement in crematoria 

PO4 – Mandatory application of emissions abatement in crematoria 

PO5 – Global agreement to ban the manufacture and trade of mercury-containing lamps 

PO6 – EU ban on the manufacture and export of MAPs   

Comparison of options 

Problem 1 - Dental Amalgam 

While the costs of PO1 are likely to  be limited, it will likely  also  yield  minimal  social and 
environmental  benefits  and  robust  quantification  of  impacts  is  not  possible  due  to 
uncertainties  surrounding  the  campaign  type  and  implementation.  Several  Member  States 
also already organise such campaigns so additional campaigns may not have much impact. In 
comparison,  PO2  will  realise  significant  social  and  environmental  benefits  but  also  would 
incur  more  costs.  An  EU  wide  phase-out  of  the  use  of  dental  amalgam  would  ensure  a 
uniform phase-out across all Member States. The extent of which these costs and benefits are 
incurred  depends  on  the  date  by  which  phase-out  comes  into  force  (phase-out  by  2025 
leading to the greatest benefits). For this reason, PO2a is the preferred option. 

Problem 2 – Emissions from crematoria 

The  phase-out  date  selected  under  PO2  subsequently  effects  the  extent  to  which  emissions 
from crematoria are reduced and will decrease the effectiveness and cost-benefit ratio of PO3 
and PO4 (as less mercury to abate). PO3 (EU guidance on abatement use) will be much lower 
cost than PO4 but with corresponding smaller environmental and human health benefits. For 
PO4a  (mandatory  uptake  of  abatement  technology  for  all  crematoria),  the  costs  are  high  in 
comparison to the benefits, in particular for SMEs. If dental amalgam is phased out by 2025 
(as in preferred option PO2a), emissions will be lower by 2030 so the cost effectiveness of 
this  option  decreases.  However,  under  PO4b  (large  crematoria  only)  the  cost  benefit  ratio 
becomes positive.  

Problem 3 – Mercury-added products  

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PO5 is considered to be the preferable option to achieve the maximum reduction of product-
related  mercury  use  but  is  associated  with  a  high  level  of  uncertainty  as  Parties  to  the 
Minamata  Convention  may  fail  to  reach  an  agreement  at  COP5  or  subsequent  COPs.  PO6 
would allow the EU to take immediate action on this issue, lowering its external footprint and 
setting  a  political  signal  in  the  international  domain.  The  risk  of  net  negative  impacts 
decreases if more time is planned between the adoption of the initiative and entry into force 
of  a  ban  and  no  negative  impacts  would  be  expected  if  this  is  followed  by  a  global  ban. 
Therefore, a ban by 2025 for dental amalgam, and 2026/28 for relevant lamps are preferred 
under PO6, but both PO5 and PO6 are retained as preferred options.  

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