COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT REPORT IMPACT ASSESSMENT 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

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 14.7.2023  SWD(2023) 396 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT REPORT  IMPACT ASSESSMENT 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) 397 final}  
 
 
TABLE OF CONTENTS 

1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ................................................. 5 

1.1.  Policy context of the initiative ...................................................................................... 5 
1.2.  Legal context of the initiative ....................................................................................... 7 

2. 

PROBLEM DEFINITION ..................................................................................................... 10 

2.1.  Problem 1 – Dental amalgam ...................................................................................... 12 
2.2.  Problem 2 – Mercury emissions from crematoria ....................................................... 15 
2.3.  Problem 3 – Manufacture of MAPs for export to third countries ............................... 19 
2.4.  Overview of problems and drivers .............................................................................. 24 
2.5.  Stakeholder views ....................................................................................................... 24 

3.  WHY SHOULD THE EU ACT? ........................................................................................... 25 

3.1.  Legal basis .................................................................................................................. 25 
3.2.  Subsidiarity: Necessity of EU action .......................................................................... 25 
3.3.  Subsidiarity: Added value of EU action ..................................................................... 25 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ................................................................. 26 

4.1.  General objectives ...................................................................................................... 26 
4.2.  Specific objectives ...................................................................................................... 26 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? ....................................................... 27 

5.1.  What is the baseline from which options are assessed? .............................................. 27 
Dental Amalgam .................................................................................................. 27 
5.1.1. 

5.1.2. 

Emissions from crematoria ................................................................................. 31 

5.1.3.  Mercury-added products for export to third countries ................................... 34 

5.2.  Description of the policy options ................................................................................ 35 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ............................................. 39 

6.1.  Problem 1 – dental amalgam use ................................................................................ 39 
Analysis of Policy Option 1 – Dental health communication campaigns ....... 39 
6.1.1. 

6.1.2. 
Analysis of Policy Option 2 – Establish a legally binding end date for the use 
of dental amalgam in the EU .............................................................................................. 40 

6.2.  Problem 2 – Emissions of mercury from crematoria .................................................. 47 
6.2.1. 
Analysis  of  Policy  Option  3  –  Publication  of  EU  guidance  on  emissions 
abatement in crematoria ..................................................................................................... 47 

6.2.2. 
Analysis of Policy Option 4 – Mandatory application of emissions abatement 
in crematoria ........................................................................................................................ 49 

6.3.  Problem 3 – Mercury-added products for export to third countries ........................... 52 
6.3.1. 
Analysis of Policy Option 5 – Global agreement to ban the manufacture and 
trade of mercury-containing lamps ................................................................................... 52 

6.3.2. 
MAPs 

Analysis  of  Policy  Option  6  –  EU  ban  on  the  manufacture  and  export  of 
54 

7.  HOW DO THE OPTIONS COMPARE? .............................................................................. 56 

1 

 
 
8. 

PREFERRED OPTION ......................................................................................................... 68 

8.1.1 PREFERRED POLICY OPTION FOR PROBLEM 1 .......................................................... 70 

8.1.2 PREFERRED POLICY OPTION FOR PROBLEM  2 ......................................................... 70 

8.1.3 PREFERRED POLICY OPTION FOR PROBLEM 3 .......................................................... 71 

8.1.4 OVERALL PREFERRED POLICY PACKAGE ................................................................. 71 

8.2.1.  REFIT ......................................................................................................................... 72 
8.2.2  ONE-IN-ONE-OUT ........................................................................................................ 74 
8.2.3.  PREFERRED INSTRUMENT............................................................................................ 75 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................... 75 

9.1. 
9.2. 

Identification of monitoring needs .............................................................................. 75 
Identification of key indicators ................................................................................... 75 

ANNEX 1: PROCEDURAL INFORMATION ............................................................................. 76 

ANNEX 2: STAKEHOLDER CONSULTATION ........................................................................ 85 

ANNEX 3: WHO IS AFFECTED AND HOW? ............................................................................ 93 

ANNEX 4: ANALYTICAL METHODS ..................................................................................... 103 

ANNEX 5: DETAILED BASELINE ........................................................................................... 110 

ANNEX 6: PROBLEMS AND DRIVERS .................................................................................. 148 

ANNEX 7: IMPACTS OF SHORTLISTED MEASURES ......................................................... 156 

ANNEX  8:  EU  AND  INTERNATIONAL  LAW  ON  MERCURY  IN  RESPECT  OF 

DENTAL AMALGAM AND MERCURY-ADDED PRODUCTS .................................... 218 

2 

 
TABLE OF ACRONYMS 

Acronym 

Meaning or definition 

AEL 

ASGM 

BAT 

BAU 

BREF 

BRG 

Associated Emission Level 

Artisanal and Small-Scare Gold Mining 

Best Available Techniques 

Business As Usual 

Best Available Techniques Reference Document 

Better Regulation Guidelines 

CAMEO 

Crematoria Abatement of Mercury Emissions Organisation 

CFL.i 

CFL.ni 

CJEU 

Compact Fluorescent Lamp with integrated ballast 

Compact Fluorescent Lamp with non-integrated ballast 

Court of Justice of the EU 

CLRTAP 

Convention on Long-Range Transboundary of Air Pollution 

COP 

Convention of the Parties 

DEFRA 

Department of Environment, Food and Rural Affairs 

DMFT 

Decayed, Missing and Filled Teeth 

EAC 

EC 

EEA 

EGD 

ELV 

EMEP 

EPA 

Equivalent Annual Cost 

European Commission 

European Environment Agency 

European Green Deal 

Emission Limit Value 

European Monitoring and Evaluation Programme 

Environmental Protection Agency 

EU / Union 

European Union 

HELCOM 

Helsinki Baltic Marine Environment Protection Commission  

Hg 

HID 

IA 

Mercury 

High Intensity Discharge Lamps 

Impact Assessment 

3 

 
 
IED 

HPS 

IQ 

LED 

LFL 

MAP 

MCP 

Industrial Emissions Directive 

High Pressure Sodium lamps 

Intelligence Quotient 

Light-Emitting Diode 

Linear Fluorescent Lamp 

Mercury-Added Product 

Medium Combustion Plant 

Member States   Member States of the European Union (EU 27)  

MIA 

NEC 

OSPAR 

OPC 

R&D 

Minamata Initial Assessment 

National Emissions Reduction Commitments 

Convention for the Protection of the Marine Environment of the North-
East Atlantic 

Online Public Consultation 

Research and Development 

REACH 

Registration, Evaluation, Authorisation and Restriction of Chemicals  

RoHS 

Restriction of Hazardous Substances 

SCENIHR 

Scientific Committee on Emerging and Newly Identified Health Risks 

SCHER 

Scientific Committee on Health and Environmental Risks 

SDG 

SMEs 

Sustainable Development Goal 

Small and Medium Size Enterprises 

Third countries  Non-EU countries 

TFEU 

TSS 

UNEP 

Treaty on the Functioning of the European Union 

Targeted Stakeholder Consultation 

United Nations Environment Programme 

UWWTP 

Urban Wastewater Treatment Plants  

WHO 

ZPAP 

World Health Organisation 

Zero Pollution Action Plan  

4 

 
 
 
 
 
1.  1.  INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

This  initiative  addresses  three  specific  issues  in  accordance  with  Article  19(1)  of 
Regulation (EU) 2017/852 on mercury (hereinafter, ‘the Mercury Regulation’)1, i.e. (i) 
the  feasibility  to  completely  phase  out  dental  amalgam  in  the  Union;  (ii)  the  potential 
need  to  regulate  at  EU  level  emissions  of  mercury  and  mercury  compounds  from 
crematoria;  and  (iii)  the  environmental  benefits  and  feasibility  to  prohibit  the 
manufacture,  import  and  export  of  certain  mercury-added  products  (hereinafter, 
‘MAPs’)2  already  banned  from  being  placed  on  the  market.  In  light  of  the  assessment 
carried out by the Commission and in accordance with Article 19(3) of this Regulation, 
the Commission intends to present a legislative proposal. This initiative is part of a wider 
EU and global policy and legal context.   

1.1. 

1.1. Policy context of the initiative 

This initiative is firstly shaped by the 2019 European Green Deal (EGD)3 as well as by 
the  2020  EU  Chemicals  Strategy  for  Sustainability4  and  the  2021  EU  Zero  Pollution 
Action Plan (ZPAP)5 adopted under it.  

Under  those  policy  documents,  the  Commission  calls  for  banning  the  most  harmful 
chemicals in consumer products and has pledged to revise EU instruments to reduce air, 
water  and  soil  pollution  to  levels  no  longer  considered  harmful  to  health  and  natural 
ecosystems,  thus  creating  a  toxic-free  environment.  The  Commission  has  therefore 
committed to revise, for instance, the CLP Regulation6 by introducing new hazard classes 
(including for bio-accumulative and toxic substances)7  and the REACH Regulation8 by 
updating  registration  requirements  and  adapting  the  processes  for  authorisation  and 

1   Regulation (EU) 2017/852 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).  

2   ‘Mercury-added  products’  refers  to  products  or  product  components  containing  mercury  or  mercury 

compounds that are intentionally added.   

3   Communication from the Commission ‘The European Green’, COM(2019) 640 final,  11.12.2019.  
4   Communication from the Commission ‘Chemicals Strategy for Sustainability  - Towards a Toxic-Free 

Environment’, COM(2020) 667 final, 14.10.2020.  

5   Communication from the Commission, ‘Pathway to a Healthy Planet for All EU Action Plan: 'Towards 

Zero Pollution for Air, Water and Soil', COM(2021) 400 final, 12.5.2021.  

6   Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008). 
7   Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 
1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of 
substances and mixtures, COM(2022) 748. 

8   Regulation (EC)  No 1907/2006 of the European Parliament and of the  Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No 793/93  and  Commission  Regulation  (EC)  No 1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (OJ L 396, 30.12.2006). 

5 

 
 
 
 
 
 
                                                           
restriction, hence increasing the protection of humans and the environment from the most 
harmful substances, including mercury. Hence, this initiative clearly fits into this context.   

Another  key  policy  objective  of  high  significance  for  this  initiative  concerns  the 
commitment by the EU under the EU Chemicals Strategy for Sustainability to ‘lead by 
example, and, in line with international commitments, ensure that hazardous chemicals 
banned  in  the  European  Union  are  not  produced  for  export,  including  by  amending 
relevant legislation if and as needed’, hence reducing its external pollution footprint. 

Secondly,  this  initiative  contributes  to  the  development  of  a  new  Union  framework  for 
sustainable  products9,  which  aims  at  complementing  existing  Union  product  ecodesign 
requirements10. It is expected that current requirements concerning, for instance, product 
energy efficiency, be supplemented by ecodesign rules on the presence of substances that 
inhibit circularity, such as mercury. Hence, whilst this initiative addresses, among others, 
the phasing-out of the manufacturing and international trade in some mercury-containing 
lamps, the proposed new ecodesign requirements aim at ensuring, simultaneously, a shift 
towards more durable and energy efficient products.  Light-emitting diode (LED) lamps 
are more energy efficiency compared to mercury-containing lamps as LED bulbs waste 
very little energy on heat, concentrating electricity on the production of light. 

The third main component of the EU policy context of this initiative is the 2005 Mercury 
Strategy11 as reviewed in 201012. Considering the risk posed by mercury to both human 
health  and  the  environment,  the  EU  developed  a  dedicated  strategy  setting  six  general 
policy  objectives  and  defining  twenty  actions  on  the  reduction  of  mercury  emissions, 
supply  and  demand  and  on  the  promotion  of  international  action  on  mercury. 
Consequently,  several  non-regulatory  and  regulatory  initiatives  were  undertaken  by  the 
EU,  including  the  adoption  of  Regulation  (EC)  1102/2008  on  mercury  exports  and 
storage13,  as  the  first  EU  legal  instrument  devoted  to  mercury.  As  an  initial  step,  this 
Regulation  addressed  only  a  select  number  of  issues,  including  the  phase-out  of  the 
export of mercury and of several mercury compounds and the obligation to make certain 
mercury waste subject to final disposal. The 2010 reviewed Mercury Strategy called for 
further initiatives and actions concerning notably dental amalgam, other MAPs and EU’s 
efforts to promote the development of an international legal framework on mercury. As a 
result, not only was a new legislative framework, i.e., the Mercury Regulation adopted 
in May 2017 addressing, inter alia, intentional uses of mercury in products, but the key 
role  played  by  the  EU  together  with  other  major  economies  in  promoting  the 

9   Proposal for a Regulation of the European Parliament and of the Council establishing a framework for 
setting  ecodesign  requirements  for  sustainable  products  and  repealing  Directive  2009/125/EC 
(COM(2022) 142 final, of 30.03.2022.  

10   Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing 
a  framework  for  the  setting  of  ecodesign  requirements  for  energy-related  products  (OJ  L  285, 
31.10.2009, p. 10). 

11   Communication  from  the  Commission  ‘Community  Strategy  Concerning  Mercury’,  COM(2005)  20 

final, 28.01.2005.  

12   Communication from the Commission on the review of the Community Strategy Concerning Mercury, 

COM(2010) 723 final, 7.12.2010. 

13   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).  

6 

 
 
 
 
 
                                                           
development  a  multilateral  environmental  agreement  resulted  also  in  the  adoption  in 
2013 of the Minamata Convention on Mercury (hereinafter ‘Minamata Convention’)14.  

The  2010  reviewed  Mercury  Strategy  was  subsequently  endorsed  by  Council 
conclusions15 that called for phasing out all mercury uses, including MAPs as follows: 

‘Mercury-added  products,  where  viable  alternatives  exist,  should  be  phased  out  as 
rapidly  and  as  completely  as  possible,  with  the  ultimate  goal  that  all  mercury-added 
products  should  be  phased-out,  taking  into  due  account  technical  and  economic 
circumstances and the needs for scientific research and development.’ 

The  global  policy  context  of  this  initiative  is  first  and  foremost  characterised  by  the 
aforementioned Minamata Convention. This Convention, which has been ratified to date 
by the EU16 and 138 countries, including all Member States and other major economies 
(e.g., US, China, Japan and Brazil), aims at protecting human health and the environment 
from  anthropogenic  emissions  and  releases  of  mercury  and  mercury  compounds.  To 
assist  Parties  in  achieving  this  objective,  the  Minamata  Convention  addresses,  amongst 
others,  intentional  uses  of  mercury  in  products,  i.e.,  including  in  dental  amalgam  and 
other  products  such  as  lamps.  As  documented  in  this  Impact  Assessment  Report  (see 
sections addressing problem 3 and Annex 8), this initiative is developed on the basis of 
the  existing  and  strong  interplay  between  Union  legislation  on  MAPs  and  the  relevant 
Minamata Convention’s provisions on products.  

Additionally,  this  initiative  contributes  to  the  implementation  within  the  EU  of  two 
Sustainable  Development  Goals  (SDGs)  i.e.,  good  health  and  well-being  ensuring 
healthy  lives  and  promoting  well-being  for  all  at  all  ages  (Goal  3)  and  responsible 
consumption  and  production  ensuring  sustainable  consumption  and  production  patterns 
(Goal 12)17, as well as to the EU decarbonisation agenda18 by promoting the substitution 
of  mercury-containing  lamps  with  more  energy-efficient  lighting  alternatives,  i.e.  LED 
lamps (see Section 6.3.1 below). 

1.2. 

1.2. Legal context of the initiative 

Whereas  mercury  and  mercury  compounds  are  addressed  in  numerous  EU  instruments, 
the  Union  legal  context  of  this  initiative  is  primarily  concerned  with  the  Mercury 
Regulation as the current dedicated EU legal instrument covering the entire life cycle of 

14  The  Minamata  Convention  that  entered  into  force  on  17  August  2017  is  available  here: 
https://www.mercuryconvention.org/sites/default/files/documents/information_document/Minamata-
Convention-booklet-Sep2019-EN.pdf  

15   Council  conclusions  Review  of  the  Community  Strategy  concerning  Mercury,  3075th  Environment 

Council meeting, 14 March 2011. 

16   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. 4–39). 

17   Agenda 2030 for Sustainable Development: https://www.un.org/sustainabledevelopment/development-

agenda/ 

18   Communication from the Commission ‘A clean planet for all a European strategic long-term vision for 
a prosperous, modern, competitive and climate neutral economy’, COM/2018/773 final, of 28.11.2018. 

7 

 
 
 
 
 
 
                                                           
mercury, from primary mining to its final disposal. This Regulation regulates, inter alia, 
the manufacture, import and export of MAPs and implements the Minamata Convention.  

As mentioned above,  whilst  this initiative is  specifically  triggered by the review clause 
established  in  Article  19  of  the  Mercury  Regulation,  the  Commission  presented  the 
outcome  of  this  review  in  its  Report  on  the  use  of  mercury  in  dental  amalgam  and 
products  adopted  in  August  2020  (hereinafter  ‘the  Commission  Review  Report’)19.  A 
summary can be found in Annex 8. This impact assessment takes forward the results to 
inform  on  the  possible  revision  of  the  Mercury  Regulation  as  far  as  dental  amalgam, 
other MAPs and mercury emissions from crematoria are concerned. 

Regarding  dental  amalgam,  Article  10(2)  of  the  Mercury  Regulation  sets  an  EU-wide 
prohibition to use dental amalgam since 1 July 2018 for dental treatment (i) of deciduous 
teeth  and  (ii)  of  vulnerable  population  (children  below  the  age  of  15,  pregnant  and 
breastfeeding  women).  Thanks  to  the  ambition  of  the  Union  to  achieve  a  mercury-free 
society both at EU and global level and to the key role played in this respect by the EU 
under the Minamata Convention, the fourth Conference of the Parties to that Convention 
(COP4)  adopted  in  March  2022  Decision  MC-4/3  amending  Annex  A  (Part  II)  to  the 
Convention by establishing therein a similar prohibition on the use of dental amalgam for 
vulnerable population.20  

As far as mercury emissions from crematoria are concerned, EU law currently sets no 
legally  binding  requirements  or  standards.  Such  emissions  are  only  addressed  at 
international level in the form of non-legally binding recommendations on the use of Best 
Available  Techniques  (BAT)  adopted  under  both  OSPAR21  and  HELCOM22  Regional 
Seas Conventions to which the EU and some Member States are Parties.       

Concerning  MAPs  (other  than  dental  amalgam),  the  legal  context  of  this  initiative 
consists  of  both  EU  and  international  law.  Under  Union  legislation,  the  manufacture, 
placing  on  the  market,  import  and  export  of  MAPs,  specifically  mercury-containing 
lamps,  is  regulated  by  several  instruments.  On  the  one  hand,  the  Mercury  Regulation 
establishes an EU-wide prohibition since 1 January 2019 and 2021 on the manufacture, 
import and export of MAPs listed in its Annex II. This list includes batteries, pesticides, 
biocides and topical  antiseptics and  certain  switches  and  relays, cosmetics,  lamps  (e.g., 
high  pressure  mercury  vapour  lamps  for  general  lighting  purposes)  and  non-electronic 
measuring  devices  (e.g.,  barometers  and  thermometers)23  and  mirrors  the  list  of  MAPs 

19   Report from the Commission to the European Parliament and the Council on the reviews required under 
Article  19(1)  of  Regulation  2017/852  on  the  use  of  mercury  in  dental  amalgam  and  products, 
COM(2020) 378 final, 17.08.2020. 

20   Decision  MC-4/3:  Review  and  amendment  of  Annexes  A  and  B  to  the  Minamata  Convention  on 
Mercury.  It  will  enter  into  force  on  28  September  2023.  The  text  of  the  Decision  is  available  at: 
https://www.mercuryconvention.org/en/meetings/cop4?document_types=307#cop-documents  

21   OSPAR Recommendation 2003/4 on Controlling the Dispersal of Mercury from Crematoria, available 

at: https://www.ospar.org/convention/agreements/page5?t=32283. 

22  HELCOM  Recommendation  29/1  (2008)  Reduction  of  emissions  from  crematoria,  available  at: 

https://helcom.fi/wp-content/uploads/2019/06/Rec-29-1.pdf.  

23  The  prohibition  on  the  export  of  MAPs  set  out  in  the  Mercury  Regulation  is  also  systematically 
thereafter  implemented  in  Annex  V  (Part  II)  to  Regulation  (EU)  No  649/2012  of  the  European 

8 

 
 
 
 
 
 
                                                           
 
contained  in  Annex  A  (Part  I)  to  the  Minamata  Convention  subject  to  a  similar 
prohibition at global level. On the other hand, restrictions on the placing on the market 
and import of those MAPs are also set out in other instruments, including  REACH and 
the RoHS Directive24.  

De jure, MAPs  that are  already  banned from  being placed on the market and imported 
under REACH, the Cosmetics Regulation25 and the Batteries Directive26, are also listed in 
Annex  II  (Part  A)  to  the  Mercury  Regulation,  hence  also  subject  to  a  manufacturing, 
export  and  import  prohibition  under  that  Regulation.  Inversely,  the  alignment  of  the 
Mercury  Regulation  with  the  existing  prohibition  set  out  under  the  RoHS  Directive  to 
place on the market and import certain mercury-containing lamps is not yet complete as 
some  of  those  lamps  (see  Table  3  below)  are  not  to  date  referred  to  in  the  above-
mentioned  Annex  II  (Part  A)  and  can  therefore  still  be  manufactured  in  the  Union  and 
exported from the EU.  

By  addressing  the  feasibility  to  further  align  EU  law  on  mercury-containing  lamps 
between  the  Mercury  Regulation  and  the  RoHS  Directive,  the  Union  must  not  only 
consider  the  difference  in  scope  of  application  of  both  those  instruments  but  must  also 
take  full  account  of  the  following  developments  that  have  taken  place  under  the 
Minamata Convention.  

Firstly,  besides  the  establishment  of  a  partial  ban  on  the  use  of  dental  amalgam, 
aforementioned Decision MC-4/3 has also extended the list of prohibited MAPs referred 
to in Annex A (Part I) to that Convention. More specifically, Parties agreed to prohibit at 
global  level  the  manufacturing,  import  and  export,  as  from  1  January  2026,  of  seven 
additional  MAPs  including:  (i)  compact  fluorescent  lamps  with  an  integrated  ballast 
(CFL.i)  for  general  lighting  purposes  that  are  ≤  30  watts  with  a  mercury  content  not 
exceeding  2.5  mg  per  lamp  burner,  (ii)  cold  cathode  fluorescent  lamps  (CCFL)  and 
external electrode fluorescent lamps (EEFL) of all lengths for electronic displays, that are 
not  yet  included  in  Annex  A  (Part  I),  (iii)  melt  pressure  transducers,  transmitters  and 
pressure sensors, (iv) mercury vacuum pumps, (v) tire balancers and wheel weights, (vi) 
photographic film and paper and (vii) propellant for satellites and spacecraft.  

Considering that such  an  extension  of the list  of  prohibited MAPs under  the Minamata 
Convention is in line with the formal proposal made by the Union ahead of COP427 and 

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). 

24   Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction 
of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 
88–110). 

25   Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 

on cosmetic products (OJ L 342, 22.12.2009, p. 59). 

26   Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries 
and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 
26.9.2006, p. 1). 

27   Council Decision (EU) 2021/727 of 29 April 2021 on the submission, on behalf of the European Union, 
of proposals to amend Annexes A and B to the Minamata Convention on Mercury, regarding mercury-
added products and manufacturing processes in which mercury or mercury compounds are used (OJ L 
55 of 5.5.2021, p. 23). 

9 

 
 
 
 
 
 
                                                                                                                                                                            
with  the  relevant  negotiating  mandate  provided  by  the  Member  States  to  the 
Commission28, those MAPs will be added to Annex II (Part A) to the Mercury Regulation 
via  a  Delegated  Act  in  accordance  with  Article  20  of  this  Regulation.  In  doing  so,  the 
addition  of  those  MAPs  is  not  subject  to  this  impact  assessment  considering  that  the 
Union  has,  in  this  respect,  no  ‘room  for  manoeuvre’  within  the  meaning  of  the  ‘Better 
Regulation’ toolbox29 that complements the 2021 EU Better Regulation Guidelines30.  

Secondly,  by  means  of  Decision  MC-4/3,  Parties  agreed  also  to  consider  at  the  fifth 
meeting of the Conference of the Parties to the Minamata Convention (COP5, November 
2023)  a  further  extension  of  the  list  of  MAPs  contained  in  Annex  A  (Part  I)  to  the 
Convention. The potential supplementary MAPs include the following linear fluorescent 
lamps  (LFLs)  for  general  lighting  purposes  not  already  covered  by  the  Convention:  (i) 
halophosphate phosphor lamps and (ii) triband phosphor lamps < 60 watts. In particular, 
whilst Parties reached an agreement at COP4 on the principle of phasing-out those LFLs, 
consensus on the phase-out dates (1st January 2026, 2028 or 2031) is still to be reached 
and  the  outcome  remains  uncertain.  As  those  LFLs  are  already  prohibited  from  being 
placed on the market and imported since 24 February 2023 in accordance with the RoHS 
Directive, this initiative endeavours to address the manufacture and export of those lamps 
at EU level.  

In  conclusion,  from  the  policy  and  legal  context  perspective,  this  initiative  aims  to 
contribute  to  increased  coherence  of  the  EU  regulatory  framework  on  MAPs  and 
implement  the  international  pillar  of  the  ZPAP,  reducing  the  EU  pollution  footprint  in 
third countries and thereby safeguarding the EU’s  credibility ahead of future Minamata 
Conferences of the Parties, including at COP5. 

2.  2.  PROBLEM DEFINITION 

Mercury is a highly toxic element and a major risk to the environment and human health. 
It  is  a  potent  neurotoxin  inducing  permanent  brain  and  kidney  damage  in  adults  and 
affecting  foetal  and  early  childhood  development.  Hence,  mercury  has  been  classified 
under  EU  law  as  being  toxic  for  reproduction,  fatal  if  inhaled,  causing  damage  to  all 
organs through prolonged or repeated exposure and very toxic for aquatic life with long 
lasting  adverse  effects31.  It  is  bio-accumulative  and,  via  food-webs  and  transboundary 
transport  of  air  pollution,  travels  around  the  globe.  Mercury  in  the  air  deposits  on  land 
and water bodies. Due to its toxicity for aquatic life, mercury also classifies as a priority 

28   Council  Decision  (EU) 2022/549  of  17 March  2022  on  the  position  to  be  taken  on  behalf  of  the 
European Union  at  the  second  segment  of  the  fourth  meeting  of  the  Conference  of  the  Parties  to  the 
Minamata Convention on Mercury as regards the adoption of a Decision to amend Annexes A and B to 
that Convention (OJ L 107, 6.4.2022, p. 78). 

29   See Better regulation’ toolbox (November 2021 edition), Tool #7 ‘What is an Impact Assessment and    
when  it  is  necessary’,  available  at:  https://ec.europa.eu/info/law/law-making-process/planning-and-
proposing-law/better-regulation-why-and-how/better-regulation-guidelines-and-toolbox_en 

30   Commission  Staff  Working  Document  ‘Better  Regulation  Guidelines’,  SWD(2021)  305  final, 

3.11.2021. 
31   Supra n° 6.  

10 

 
 
 
 
  
 
                                                           
hazardous substance under Union water legislation, which implies that mercury releases 
into water bodies must cease at a certain point in time32. For this reason and considering 
the  toxicity  of  mercury  to  human  health,  the  EU  has  set  maximum  limit  values  for 
mercury content in fish for consumption (most large predatory fish)33.  

Mercury  can  be  released  to  the  environment  by  natural  sources  (earth’s  crust,  volcanic 
emissions,  geothermal  activities,  or  forest  fires)  as  well  as  anthropogenic  sources 
resulting  either  from  activities  whereby  mercury  is  added  intentionally  (dental 
amalgam  and  other  MAPs)  or  where  mercury  is  emitted  non-intentionally  as  a  side-
product  (coal-fired  power  plants,  residential  coal-burning  for  heating  and  cooking  or 
waste incinerators)34. A general problem definition of mercury can be found in Annex 6. 

At  global  level  and  based  on  the  latest  UNEP  global  mercury  assessment35,  the  largest 
anthropogenic mercury emissions to the environment occur from fossil fuel combustion 
(533 t/year), industrial processes (614 t/year) and artisanal small-scale gold mining (838 
t/year). Annual world-wide emissions to air were estimated to amount to 2.200 t of which 
the  EU(28)  is  responsible  for  77.2  t  i.e.,  3.5%  (2015).  Regarding  more  specifically  the 
use  and  disposal  of  MAPs,  including  dental  amalgam  and  mercury-containing  lamps, 
global emissions to water were estimated to amount to 99.4 t/year, i.e., about 17% of all 
mercury emissions (2015).  

In the EU, the total quantity of anthropogenic mercury emissions has been steadily and 
significantly decreasing over the past 20 years, largely thanks to a dedicated Community 
strategy on Mercury (2005 and 2010) and related EU legislation (e.g., RoHS Directive), 
determined  action  at  global  level  having  led  to  the  creation,  in  2017,  of  the  Minamata 
Convention,  the  decarbonisation  agenda  as  well  as  the  Mercury  Regulation,  which  has 
prohibited  since  2018  most  intentional  uses  of  mercury  (including  for  manufacturing 
processes,  artisanal  and  small-scale  gold  mining  and  dental  amalgam  for  vulnerable 
populations).  

The objective of this initiative is to address the continued intentional use of mercury in 
dentistry and products, as the largest remaining intentional uses of mercury in the EU, 
with a view to minimising the EU’s contribution to the global build-up of mercury. 

It  is  estimated that this initiative would cover between 52.9 and 87.9 t/year of mercury 
stemming from such MAPs. Such amounts can be broken down as follows: 

  40.4 t/year of mercury in dental amalgam for use in the EU  

32   See  Annex X to Directive 2000/60/EC of the European Parliament and of  the  Council of 23 October 
2000  establishing  a  framework  for  Community  action  in  the  field  of  water  policy  (OJ  L  327, 
22.12.2000, p. 1).  

33   Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain 

contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5). 

34  WHO,  2017.  Mercury  and  health  (https://www.who.int/news-room/fact-sheets/detail/mercury-and-

health) 

35  UNEP  (2019)  Global  Mercury  Assessment  2018,  available  at  https://www.unep.org/explore-

topics/chemicals-waste/what-we-do/mercury/global-mercury-assessment  

11 

 
 
 
 
 
 
  
  
                                                           
  13-38 t/year36 of mercury in dental amalgam exported from the EU  
  0.5 t/year of mercury used for fluorescent lamps exported from the EU 
  1 t/year of mercury emissions from crematoria  

This section describes the three elements linked to the review of the Mercury Regulation. 
Dental amalgam (use) is considered as Problem 1, emissions from crematoria as Problem 
2  and  MAPs  (manufacture  and  export  of  dental  amalgam  and  of  certain  mercury-
containing lamps) are addressed under Problem 3. Each of the three problems is treated 
with its own set of policy options that respond directly to the identified problem drivers 
and specific objectives. The three problems are obviously interlinked as for example the 
phase-out of the use of dental amalgam in the EU will automatically lead to a reduction 
of mercury emissions from crematoria in the longer term.   

2.1. 

2.1. Problem 1 – Dental amalgam  

The first problem concerns the risks for health and the environment associated with the 
use of dental amalgam. 

Dental  amalgam  has  been  used  as  a  dental  filling  material  for  centuries  to  fill  dental 
cavities caused by tooth decay and to restore tooth surfaces. It is a product composed of 
metallic  powders  like  copper,  silver,  tin,  etc.  mixed  with  mercury,  where  mercury 
represents 42% to 53% of the amalgam’s mass37,38,39. 

Whilst  EU  policy  and  law  on  mercury  aims  explicitly  at  eliminating  mercury  use  and 
associated pollution, especially when mercury-free alternatives are feasible and available, 
dental amalgam still represents the largest remaining intentional use of mercury in the 
EU.  This  leads  to  adverse  human  health  effects  and  mercury  emissions,  in  particular 
during  placement  by  dental  practitioners  and  via  excretion40,  cremation  or  burial  of 
people fitted with dental amalgam41. The continued use of dental amalgam is therefore a 
practice  that  contributes  to  the  continuous  build-up  of  mercury  in  the  environment  and 
excessive and unsustainable amounts of mercury in fauna, flora and habitats.   

Regarding  the  EU  dimension  of  the  problem,  the  mean  total  mercury  used  in  dental 
amalgam in the EU is estimated to be 40.4 t in 2019 (18.6 t in teeth and 21.8 t as waste) 

36   Due to the lack of credible export data the amount of mercury exported in the form of dental amalgam 

can only be roughly estimated, hence a range is presented 

37   See directions for use regarding dental amalgam product Permite lojic+ & gs-80: 
   https://www.sdi.com.au/pdfs/instructions/pt-br/gs-80_sdi_instructions_pt-br.pdf  
38   See directions for use regarding dental amalgam product Septalloy NG 70, Securalloy: https://uploads-
ssl.webflow.com/571024186d8e1cce4121d731/5be974bc16344085fcc0f4d6_S%2005%2086%20050%
2005%2000_6amalgam-SP.pdf   

39   See 

directions 

for 

use 

regarding 

dental 

amalgam 

product 

Dispersalloy: 

http://www.dentsplyestore.com.au/www/770/files/dispersalloy_capsules_dfu.pdf   

40    The  Contribution  Of  Dental  Amalgam  To  Urinary  Mercury  Excretion  In  Children  |  Environmental 
Health  Perspectives  |  Vol.  115,  No.  10".  2022,  https://ehp.niehs.nih.gov/doi/full/10.1289/ehp.10249  
Accessed 31 Mar 2022. 

41   Alwyn Hart, Ammonia shadow of my former self: a review of potential groundwater chemical pollution 

from cemeteries, Land contamination & Reclamation, 13 (3), 2005 

12 

 
 
 
 
 
 
 
                                                           
with  the  lower  estimate  being  31.6  t  and  the  upper  estimate  being  50.3  t.  The  use  of 
dental amalgam for the treatment of dental cavities varies across Member States (Table 
1). 

Whereas SE is to-date the only Member State having completely phased out the use of 
dental  amalgam,  many  other  Member  States  have  made  significant  progress  in  phasing 
down its use. Yet, eight Member States (AT, HR, CZ, EL, MT, PL, SK, SI) in 2019 still 
conducted  close  to  or  over  50%  of  their  dental  treatments  using  dental  amalgam, 
although  several  of  them  have  since  phased-out  or  announced  their  intention  to 
progressively phase-out dental amalgam use before 2030. Yet, Table 1 below shows that, 
in the absence of EU regulatory intervention, dental amalgam would continue to be used, 
in some Member States with rather high quantities, well beyond 2025. 

Table 1: Dental amalgam use per Member State (2019, 2025 and 2030) 

Amalgam 
use % 

2019 (t) 

Predicted 
2025 (t) 

Predicted 
2030 (t) 

AT 
BE 
BG 
HR 
CY 
CZ 
DK 
EE 
FI 
FR 
DE 
EL 
HU 
IE 
IT 
LV 
LT 
LU 
MT 
NL 
PL 
PT 
RO 
SK 
SI 
ES 
SE 
EU total 

43% 
7% 
21% 
43% 
21% 
43% 
1.7% 
2.5% 
1% 
25% 
6% 
43% 
7% 
20% 
2.5% 
21% 
4.6% 
21% 
43% 
0.5% 
43% 
10% 
7.5% 
50% 
70% 
1% 
0% 

1.291 
0.427 
0.379 
0.110 
0.008 
2.656 
0.065 
0.005 
0.002 
18.730 
3.433 
0.192 
0.476 
0.998 
0.663 
0.178 
0.105 
0.009 
0.006 
0.087 
7.182 
0.849 
0.464 
0.279 
1.650 
0.182 
0.000 
40.4 t 

0.579 
0.150 
0.146 
0.000 
0.004 
0.100 
0.025 
0.002 
0.000 
7.860 
1.458 
0.073 
0.077 
0.000 
0.000 
0.078 
0.047 
0.004 
0.003 
0.037 
0.000 
0.261 
0.149 
0.146 
0.000 
0.000 
0.000 
11.2 t 

0.893 
0.285 
0.225 
0.000 
0.005 
1.765 
0.040 
0.004 
0.001 
11.444 
2.310 
0.112 
0.305 
0.657 
0.000 
0.112 
0.064 
0.006 
0.004 
0.048 
0.000 
0.444 
0.283 
0.184 
1.094 
0.102 
0.000 
20.4 t 

13 

 
 
 
 
 
 
 
The  continued  use  of  dental  amalgam  notwithstanding  the  availability  of  mercury-free 
alternatives is mainly motivated by:  

 

 
 

lack  of  communication  to  and  awareness  of  mercury-free  alternatives  among 
relevant patients,  
lack of training of dental practitioners to use such alternatives,  
higher costs incurred by patients  in  some EU Member States  (e.g., DE,  IT) when 
seeking the reimbursement of mercury-free versus mercury-added dental amalgam 
from  national  social  security  services  or  private  insurances,  creating  an  uneven 
level of health insurance coverage across the EU. 

Additionally,  limited  continued  use  of  dental  amalgam  across  the  EU  results  from  the 
specific  medical  conditions  of  some  patients  (allergies  to  some  components  of  the 
mercury-free  amalgams,  excessive  saliva  production,  acute  anxiety)  for  whom  dental 
amalgam  is  the  only  appropriate  dental  treatment  technique  due  to  either  its  chemical 
properties or its reportedly faster application time. 

In  addition  to  the environment being directly affected by mercury  emissions associated 
with  the  use  of  dental  amalgam,  specifically  via  emissions  from  crematoria,  the  main 
exposure  to mercury in  individuals  with amalgam restorations  occurs  during  placement 
or removal of the fillings42, if not handled properly. Furthermore, low levels of exposure 
may also occur through the lifetime of a restoration.  

In  terms  of  evolution  of  the  problem,  the  advantages  that  have  historically  been 
associated with the use of dental amalgam were that it was cheaper than its mercury-free 
counterpart and easier and quicker to  place. However, the  alternatives are now as cost-
effective as dental amalgam and practitioners are increasingly replacing dental amalgam 
with  these  alternatives.  It  is  therefore  expected  that  the  use  of  dental  amalgam  will 
decrease to 11.2 t by 2030 (with a lower estimate of 7.2 t and an upper estimate of 16.8 
t). This is due to increased patient awareness with regards to mercury’s negative health 
and environmental impacts and increased reliability of mercury-free alternatives and their 
aesthetic advantages. Nevertheless, the remaining amount will still represent the largest 
remaining  intentional  use  of  mercury  in  the  EU  and  continue  to  circulate  through 
environmental  media  (air,  water  and  soil).  Furthermore,  with  no  policy  intervention  at 
EU level,  a phase-out  is predicted to  take place  at  a much slower pace and at  different 
times across the EU. 

Problem drivers for Problem 1 

Driver  1  –  Market  failure:  Across  the  EU,  whilst  mercury-free  alternatives  have 
become  as  cost-effective  as  dental  amalgam,  an  uneven  level  of  health  insurance 
coverage  between  dental  amalgam  and  alternatives  creates  higher  costs  for  patients 
choosing  mercury-free  alternatives.  Furthermore,  although  the  price  of  dental  amalgam 

42  Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) ‘The safety of dental 

amalgam and alternative dental restoration materials for patients and users’ (2008) 

14 

 
 
 
 
 
 
 
 
                                                           
varies  among  Member  States,  its  price  often  does  not  reflect  the  damage  costs  of 
mercury.  

Driver 2 – Regulatory failure: The use of dental amalgam is only partially prohibited 
for  vulnerable  populations  (i.e.,  children  below  the  age  of  15  years,  pregnant  and 
breastfeeding  women)  at  EU  level.  The  level  to  which  this  prohibition  extends  or  will 
extend to other members of the population varies a lot between the EU Member States.   

Driver 3 – Behavioural biases: In the EU, despite dental health improving over recent 
years, several problem drivers, including improper dental hygiene and poor eating habits 
continue  to  cause  cavities,  which  require  treatment  and  continue  to  do  so  as  cavities 
cannot  be  eradicated  completely.  This  is  particularly  important  for  vulnerable  and 
socially excluded groups in society  who experience significantly poorer oral health and 
access to dental services than the mainstream population43. 

2.2. 

2.2. Problem 2 – Mercury emissions from crematoria 

Crematoria continue to be an important source of mercury emissions in the EU44,45. These 
emissions originate mainly from mercury amalgam fillings in human remains.  

In  2019,  the  EU  had  over  1.200  crematoria  (see  Table  2  below  and  Annex  5)  and 
experienced  between  2010  and  2019  a  38%  increase  in  annual  cremation  numbers 
(from 1.5 million to over 2.1 million) (see Table 3).  

Table 2: Number of crematoria by capacity band by Member State (2019) 

Number of crematoria, 2019 (by capacity band) 

Member 
State 

<1,000 

1,000 – 
2,000 

2,000 – 
3,000 

3,000 – 
4,000 

4,000 – 
5,000 

>5,000 

Total 

% change 2010 
- 2019 

AT 
BE 
BG 
CY 
CZ 
DE 
DK 
EE 
EL 
ES 
FI 
FR 
HR 

1 
1 
1 
0 
2 
8 
1 
2 
1 
434 
3 
88 
0 

2 
3 
0 
0 
5 
22 
10 
0 
0 
0 
12 
71 
0 

4 
6 
0 
0 
10 
50 
6 
0 
0 
0 
4 
21 
0 

2 
4 
0 
0 
4 
30 
0 
0 
0 
0 
0 
3 
0 

3 
4 
0 
0 
4 
38 
0 
0 
0 
0 
1 
1 
0 

1 
1 
0 
0 
2 
11 
2 
0 
0 
0 
0 
1 
1 

13 
19 
1 
0 
27 
159 
19 
2 
1 
434 
20 
185 
1 

18% 
58% 
0% 
N/A 
0% 
5% 
-38% 
0% 
N/A 
No 2010 data 
-9% 
23% 
0% 

43   Watt RG, Venturelli R, Daly B. Understanding and tackling oral health inequalities in vulnerable adult 
populations:  from  the  margins  to  the  mainstream.  Br  Dent  J.  2019  Jul;227(1):49-54.  doi: 
10.1038/s41415-019-0472-7. PMID: 31300784. 

44   Supra No. 18  
45  OSPAR  Commission  (2004).  OSPAR  Background  Document  on  Mercury  and  Organic  Mercury 

Compounds (2004 Update). https://www.ospar.org/documents?v=6904  

15 

 
 
 
 
 
 
 
 
                                                           
Number of crematoria, 2019 (by capacity band) 

Member 
State 

<1,000 

1,000 – 
2,000 

2,000 – 
3,000 

3,000 – 
4,000 

4,000 – 
5,000 

>5,000 

Total 

% change 2010 
- 2019 

HU 
IE 
IT 
LT 
LU 
LV 
MT 
NL 
PL 
PT 
RO 
SE 
SI 
SK 
EU-27 

1 
5 
29 
0 
0 
0 
0 
66 
12 
1 
4 
25 
0 
0 
685 

1 
1 
19 
0 
0 
0 
0 
24 
13 
4 
0 
24 
0 
0 
211 

2 
1 
26 
0 
1 
0 
0 
6 
17 
6 
0 
5 
0 
0 
165 

5 
0 
8 
0 
0 
1 
0 
1 
7 
3 
0 
2 
0 
0 
70 

5 
0 
2 
1 
0 
0 
0 
1 
2 
4 
0 
0 
0 
1 
67 

3 
0 
1 
0 
0 
0 
0 
1 
1 
2 
0 
2 
2 
2 
33 

17 
7 
85 
1 
1 
1 
0 
99 
52 
20 
4 
58 
2 
3 
1,231 

42% 
75% 
47% 
N/A 
0% 
0% 
N/A 
43% 
300% 
400% 
300% 
-12% 
0% 
0% 

Crematoria numbers are estimated to steadily increase across the EU (to 1,482 crematoria 
in  EU27  in  2030),  based  on  an  extrapolation  of  trends  over  the  past  10  years  and 
supported by feedback from stakeholders as part of the consultation activities.  

Table 3: Change in number of cremations (2010, 2019) per Member State 

Member 
State 
AT 
BE 
BG 
CY 
CZ 
DE 
DK 
EE 
EL 
ES 
FI 
FR 
HR 
HU 
IE 
IT 
LT 
LU 
LV 
MT 
NL 
PL 
PT 

Number of cremations 
2010 
25,553 
51,062 
364 
0 
86,405 
487,135 
42,048 
538 
0 
174,649 
21,103 
165,907 
39,258 
79,217 
3,134 
76,902 
1,425 
2,228 
1,010 
0 
77,471 
34,063 
56,632 

2019 
41,869  
67,794  
519  
0 
88,901  
648,269  
46,134  
1,967  
487  
185,332  
30,956  
239,283  
38,647  
86,898  
7,025  
194,639  
4,888  
2,810  
3,540  
0 
101,687  
132,746  
64,259  

Change 
64% 
33% 
43% 
0% 
3% 
33% 
10% 
266% 
N/A 
6% 
47% 
44% 
-2% 
10% 
124% 
153% 
243% 
26% 
250% 
N/A 
31% 
290% 
13% 

16 

 
 
 
 
 
 
Member 
State 
RO 
SE 
SI 
SK 
EU27 

Number of cremations 
Change 
2019 
2010 
46% 
1,248  
857 
6% 
73,631  
69,548 
20% 
17,506  
14,569 
259% 
17,248 
4,810 
1,517,897  2,100,301  38% 

Regarding mercury emissions from crematoria, this represents a 14% increase (from 821 
kg to 934 kg) as shown in Figure 1 based on Member State reporting under CLRTAP46. 
The  wider  public  is  impacted  through  exposure  to  mercury  emissions  from  crematoria. 
Applying  EEA  damage  cost  functions  for  mercury47  (which  take  into  account  mortality 
and IQ loss), the impacts of these emissions are valued at approximately €16 million48 per 
year. 

Figure  1:  Annual  crematoria  mercury  emissions  to  air  for  the  EU  27  as  reported  by  the 
Member States under CLRTAP (2000-2019) 

Data from EMEP (2022)49 

46    It  should  be  noted  that  these  figures  are  based  on  Member  State  reporting  under  CLRTAP  and  more 
robust estimates of emissions have been developed for this study for the baseline which are described in 
Section 5.1.2. 

47    Damage  costs  express  an  impact  value  associated  with  a  given  volume  of  pollutant  emission.  EEA 
damage costs for mercury account for health impact including cardiovascular mortality and IQ loss. 

48   2019 prices. Based on a marginal damage cost of €16,903 per kg. See: 
   https://www.eionet.europa.eu/etcs/etc-atni/products/etc-atni-reports/etc-atni-report-04-2020-costs-of-
air-pollution-from-european-industrial-facilities-200820132017/@@download/file/ETC-ATNI_2020-
4_Task-1222_FINAL_v2_17-08-2021.pdf  

49    OSPAR  Convention  (2011).  Implementation  of  OSPAR  Recommendation  2003/4  on  Controlling  the 

Dispersal of Mercury from Crematoria: Second Overview assessment. 

    https://www.ospar.org/documents?v=35427 

17 

 
 
 
 
 
 
                                                           
Crematoria  operators  do  not  fall  under  the  scope  of  application  of  the  2010/75/EU 
Industrial  Emissions  Directive50:  hence,  they  are  not  subject  to  an  obligation  under  EU 
law to make use of best available techniques (BAT).  

The size of crematoria and businesses that operate crematoria varies significantly across 
the  EU.  For  example,  ES  has  the  highest  number  of  crematoria  in  Europe,  but  most 
crematoria  are  estimated to  carry out  less than 350 cremations a  year51.  In contrast,  the 
average  crematorium  in  HR  carries  out  over  5,000  cremations  per  year.  It  is  estimated 
that more than half of all crematoria in the EU are small (less than 1,000 cremations per 
year) as presented in Table 2 (see Annex 5 for number of crematoria and cremations per 
Member State).  

Emissions  of  mercury  from  crematoria  can  be  avoided  through  the  application  of 
abatement  technologies.  The  most  used  technologies  include  Injection  of  Absorbent  or 
Solid  Bed  Filtration  using  Absorbent.  A  list  of  Member  States  applying  abatement 
technologies  can  be  found  in  Annex  5.  Uptake  of  emissions  abatement  technologies  in 
crematoria  is  anticipated  to  increase  in  future  years,  at  least  in  some  Member  States, 
although  this  is  highly  uncertain.  In  case  of  no  EU-wide  policy  intervention,  any 
prolonged use of dental amalgam will therefore entail continued mercury emissions from 
crematoria. The phase-out of dental amalgam would lead over time, taking into account 
legacy dental amalgam (the average life expectancy of a dental amalgam filling is 15 to 
20  years),  to  a  cessation  of  mercury  emissions  from  crematoria  and  their  associated 
environmental risks.  

Problem drivers for Problem 2 

The evidence points out to only two drivers for this problem as there is no indication for 
a  market  failure.  The  fact  that  environmental  requirements  are  different  in  the  various 
Member  States  might  lead  to  marginally  different  costs  for  the  cremation  as  usually, 
operators  transfer  these  costs  to  the  consumers  via  the  application  of  an  environmental 
levy. The cost of the cremation itself as a proportion of total funeral cost is low (around 
10-20%) and the potential additional costs for abatement would not significantly change 
the overall cost. 

However,  the  evidence  points  quite  clearly  towards  no  market  distortion  amongst 
Member States when it comes to cremation, not even in transboundary areas. In general, 
the cross-border transportation of deceased people occurs in cases of repatriation, where 
the  main  factor  driving  the  transportation  is  social  rather  than  financial  (returning  the 
body  to  hold  a  cremation  or  funeral  where  they  or  their  loved  ones  live).  As  costs  for 
repatriation are quoted to be in the order of thousands of euros, it is unlikely that small 
financial  differences  between  cremation  costs  in  neighbouring  Member  States  are 
causing transboundary effects.  

50   Directive  2010/75/EU  of  the  European  Parliament  and  of  the  Council  of  24 November  2010  on 

industrial emissions (OJ L 334, 17.12.2010, p. 17–119). 

51   Analysis of the Funeral Market in Spain, Available at: https://news.wfuneralnet.com/en/funeral-market-

spain/  

18 

 
 
 
 
 
 
 
                                                           
to  control  mercury  emissions  from  crematoria.  At 

Driver  1  –  Regulatory  failure:  There  is  no  provision  in  EU  law  requiring  Member 
States 
level, 
recommendations  for  the  use  of  abatement  technologies  using  BAT  have  been  adopted 
by  both  the  OSPAR  and  HELCOM  Commissions.  These  Recommendations  are  non-
legally  binding  and  only  15  Member  States  are  signatories  to  the  OSPAR  and/or 
HELCOM Conventions. In this context, what is most apparent from available data is that 
the use of mercury emission abatement technologies across the EU varies significantly, 
with  very  high  levels  of  uptake  in  some  Member  States  (BE,  DE,  LU,  NL,  DK),  and 
much lower uptake in others (PT, ES). 

international 

Driver  2  –  Behavioural  biases:  Regarding  mercury  emissions  from  crematoria,  the 
number of cremations  conducted annually in  the EU is  increasing.  Beyond the spike in 
numbers  linked  to  the  tragic  loss  of  life  due  to  the  COVID-19  pandemic,  the  average 
increase,  but  also  the  variations  in  cremation  rates  across  the  EU  is  linked  to  social 
factors  (i.e.,  costs  of  services,  personal  preferences  for  cremation  over  burial)  and 
cultural preferences (i.e., religious practices). 

2.3. 

2.3.  Problem 3 – Manufacture of MAPs for export to third countries   

The third problem  that this  initiative addresses  are the adverse impacts  of EU exported 
MAPs on third countries. For the purpose of this initiative, the expression ‘MAPs’ under 
problem  3  concerns  dental  amalgam  and  certain  mercury-containing  lamps  (see  also 
Section 1.2 and Annex 8).  

Those  exports  highlight  the  current  inconsistencies  affecting  Union  law  on  MAPs. 
Various  EU  legal  provisions  have  been  developed  and  implemented  to  prohibit  the 
placing  on  the  EU  market  and  import  into  the  EU  of  MAPs,  including  under  REACH, 
RoHS  and  Ecodesign52.  The  Mercury  Regulation  complements  those  provisions  by 
additionally prohibiting the manufacture and export of those MAPs (see Figure 2). This, 
in  turn,  weakens  the  EU’s  position  and  reputation  as  a  leading  player  within  the 
international  community  and  jeopardising  the  objectives  set  out  in  the  ZPAP  on  the 
reduction  of  the  EU’s  external  pollution  footprint.  Furthermore,  at  an  EU-level,  such 
inconsistencies can cause regulatory uncertainty for industry.  

52  See  Commission Regulation (EU) 2019/2020 of 1 October 2019 laying down ecodesign requirements 
for  light  sources  and  separate  control  gears  pursuant  to  Directive  2009/125/EC  of  the  European 
Parliament  and  of  the  Council  and  repealing  Commission  Regulations  (EC)  No  244/2009,  (EC)  No 
245/2009 and (EU) No 1194/2012 (OJ L315 of 5.12.2019, p. 209.) 

19 

 
 
 
 
 
 
 
                                                           
Figure 2: Interaction between EU legal instruments concerning the manufacture and trade 
of MAPs 

As a result, there are MAPs that are prohibited for placing on  the EU market and 
import  into  the  Union  whilst  still  being  manufactured  in  the  Union  for  export  to 
third countries. An overview of relevant MAPs currently or soon no longer allowed to 
be  placed  on  the  EU  market  but  allowed  for  manufacture  and  export  can  be  found  in 
Table 4 below. 

Table 4: Mercury-containing lamps addressed by this impact assessment (as they are not or 
will soon no longer be allowed on the internal market but continue to be manufactured and 
exported) 

Products 

Compact fluorescent lamps (CLFs) for general lighting purposes not already covered by 
Annex II of the Mercury Regulation 

Linear  triband  phosphor  lamps  for  general  lighting  purposes  not  already  covered  in 
Annex II of the Mercury Regulation 

Halophosphate  phosphor  lamps  for  general  lighting  purposes  not  already  covered  in 
Annex II of the Mercury Regulation 

Non-linear tri-band phosphor lamps for general lighting purposes 

High Pressure Sodium (vapour) lamps (HPS) for general lighting purposes not exceeding 
(per burner) in lamps with improved colour rendering index Ra:  

a)  > 60: P ≤ 155 W 
b)  > 60: 155 W < P ≤ 405 W 
c)  > 60: P > 405 W 

20 

 
 
 
  
 
 
The  continued  export  of  concerned  MAPs  is  a  significant  cause  of  mercury  pollution, 
especially  in  third  countries  where  EU-made  products  add  to  the  national  burden  of 
hazardous products and increase the risk for local retailers, end-users, and inhabitants. In 
most low to medium-income third countries, few if any options exist for environmentally 
sound  disposal  of  mercury-containing  end-of-life  products53,54.  In  the  2018  Global 
Mercury  assessment55, it was assumed that in  many  countries  over  95% of MAPs were 
not separately collected and recycled but ended up in landfills and (much less frequently) 
in uncontrolled waste incinerators. This causes emissions to the environment and adverse 
health impacts for those populations that handle waste or live or work near disposal sites. 
Due to mercury’s transboundary nature and accumulation in food chains, mercury that is 
released anywhere in the world56 in turn poses a risk to European citizens. 

Regarding  the  size  of  the  identified  problem,  dental  amalgam  and  mercury-containing 
lamps  are  the  key  MAPs  in  terms  of  volume,  export  values  and  mercury  content. 
Accordingly, this initiative addresses those products specifically. Considering that a ban 
on the use of dental amalgam is assessed in this impact assessment (PO2a), problem area 
3  also  addresses  the  manufacture  and  export  of  dental  amalgam  in  order  to  align  the 
prohibition of manufacture and export with the ban on use. 

Based on previous information on the relative ratio of EU demand, import, and export, it 
was estimated that with respect to mercury content, dental amalgam is the most relevant 
exported MAP (Table 5). The amount of mercury in exported dental amalgam  is in 
the order of 13 to 38 t in 2018.  

Table 5: Estimated mercury content in exported MAPs (only those for  which quantitative 
data is available are listed) 

Product 

Dental amalgam (in capsules) 

Mercury content in 
exported product per 
year 

13 – 38 t (2019) 

Hot  cathode  discharge  lamps  (CFLs,  LFLs  and  other 
double-capped FLs) 

0.46 t (2020) 

High Pressure Sodium (vapour) lamps (HPS) 

≈ 0.024 t (2020) 

53   UNEP (2017) Global Mercury Waste Assessment. 49 pp 
54   UNIDO (2019) No time to waste: International expert group meeting on the sustainable management of 

mercury waste. 56 pp. 

55   UNEP (2019) Global Mercury Assessment 2018 
56  EEA Report No 11/2018 Mercury in Europe’s environment: A priority for European and global action, 

p.7 

21 

 
 
 
 
 
 
 
 
                                                           
Regarding  export  value,  lamps  (CFLs,  LFLs  and  other  double-capped  FLs,  HPS)  are 
much  more  important.  According  to  published  export  data  (EU  PRODCOM57  and  UN 
COMTRADE58),  in  2020  the  EU  exported  about  156  million  hot  cathode  discharge 
lamps (CFLs,  LFLs and other double-capped FLs) with  a  value of about €92  million. 
This corresponds to a mercury content in the order of 460 kg. 

Table 6: Estimated value of exported MAPs 

Product 

Hot  cathode  discharge  lamps  (CFLs,  LFLs 
and other double-capped FLs) 

No. of exported 
MAPs (Mio. units) 

Value of exported 
MAPs (Mio. €) 

156 (2020) 

92 (2020) 

Dental amalgam (in capsules) 

≈ 21-64 (2019) 

≈ 21-64 (2019) 

High  Pressure  Sodium  (vapour) 
(HPS) 

lamps 

≈ 1 

Not quantified 

A significant share of these lamps exported from the EU are destined for countries with 
very low collection and recycling rates for electronic waste i.e., 0.4% in UAE59 and 2.5% 
in  the  Russian  Federation.  Furthermore,  as  opposed  to  the  EU  which  requires  the 
installation of amalgam separators in dental practices, dental amalgam waste is often not 
collected  separately  in  developing  countries,  but  instead  ends  up  in  the  normal  waste 
stream60,61,62. Often, amalgam waste is disposed of in landfills without further treatment or 
incinerated together with other medical waste. It  can therefore be assumed that most of 
the mercury waste from dental practices is released into the environment. 

Following declining demand and global competition, many production lines in the Union 
for  fluorescent  lamps  have  already  been  closed  in  recent  years.  According  to  available 
information, the Impact Assessment identified only the four following factories in the EU 
that still produce fluorescent lamps for general lighting purposes63: 

  Signify / Philips (PL)  

57   See EU PRODCOMM at https://ec.europa.eu/eurostat/web/main/home   
58   See UN COMTRADE at https://comtradeplus.un.org/   
59   See United Nations University, UNITAR, ITU, ISWA (2020) The global e-waste monitor 2020; United 
Nations  University,  UNITAR,  ITU  (2021)  Regional  e-waste  monitor  for  the  Arab  states  2021;  Saudi 
Daz  Electronic  and  Solid  Waste  Recycling  Factory  (2022)  What  Is  E-Waste?  Available  online  at: 
https://www.dazrecycling.com.sa/e-waste/ (last accessed on 9 March 2022). 

60  Singh, R.D.; Jurel, S.K.; Tripathi, S.; Agrawal, K.K.; Kumari, R. (2014) Mercury and Other Biomedical 
Waste Management Practices among Dental Practitioners in India. BioMed Res. Intl. 2014, ID 272750, 
61  Daou, M., H.; Karam, R.; Khalil, S.; Mawla, D. (2015) Current status of dental waste management in 

Lebanon. Environm. Nanotechn. Monit. Man. 4, 1-5 

62  Makanjuola, J.; O.; Ekowmenhenhen, U. I.; Enone, L.; L.; Umesi, D. C.; Ogundana, O. M.; Arotiba, G. 
T.  Chioma,  D.  (2021)  Mercury  hygiene  and  biomedical  waste  management  practices  among  dental 
health-care personnel in public hospitals in Lagos State, Nigeria. Afri Health Sci. 2021;21(1):457-69  

63  CLASP (2022) Refurbishing Europe’s Fluorescent Lamp Manufacturing Facilities.  
     https://www.clasp.ngo/research/all/refurbishing-europes-fluorescent-lamp-manufacturing-facilities/ 

22 

 
 
 
 
 
 
 
                                                           
  Feilo Sylvania (DE)  
  Tungsram, announced to be closed by the end of 2022 (HU) 
  Ledvance / Osram (IT)  

Available information shows that, until recently, there were 23 companies located within 
the EU that produced dental amalgam. 19 of them have stopped amalgam production in 
Europe or announced to do so by the end of 2024. The Impact Assessment identified only 
the following four EU companies producing encapsulated dental amalgam: 

  Cavex (NL) 
  Madespa S.A. (ES) 
  Global Dental Trade (CZ) 
  World Work Srl (IT) 

Although  a  trend  cannot  be  predicted  for  every  single  product  type,  a  general  trend  of 
continuously decreasing EU export of MAPs can be observed. The increasing awareness 
about  mercury-related  risks,  strengthened  national  and  global  legal  regulation,  and  the 
availability  of  effective  and  affordable  mercury-free  alternatives  are  the  main  driving 
forces  to  further  push  MAPs  out  of  the  market.  An  increasing  ambition  towards 
eliminating MAPs at international level has led (at COP4) to decisions being adopted at 
global level. However, the continued level of ambition at future COPs, will still depend 
on Parties domestic regulatory regime and interests and thus remains uncertain. 

In the absence of alignment between the Mercury Regulation and RoHS, inconsistencies 
within the EU acquis will lead to continued contribution by the Union to the availability 
of MAPs on the global market. 

Problem drivers from Problem 3 

Driver  1  –  Market  failure:  Although  for  many  MAPs  the  transition  to  mercury-free 
alternatives  is  technically  feasible,  the  cost  and  availability  of  such  alternatives 
influences  the  external  market  choice.  Lower  product  prices  that  do  not  reflect 
environmental and human health costs and mask higher energy costs sustain demand for 
MAPs.  European  manufacturers  of  MAPs  are  sometimes  reluctant  to  voluntarily  leave 
the  MAP  market  and  forego  revenues.  In  addition,  the  ongoing  supply  from  EU 
manufacturers  slows  down  the  transition  process  and  keeps  mercury  in  circulation 
globally. 

Driver 2 – Regulatory failure: Inconsistencies within EU law on MAPs (placing on the 
market  and  import  prohibition  vs.  manufacture  and  export  allowed)  entitles  the  EU  to 
manufacture  and  export  certain  MAPs,  for  which  mercury-free  alternatives  exist.  In 
doing so, the EU supplies the global market with mercury which in turn disincentives the 
shift towards mercury-free alternatives and harms the EU’s reputation in the light of the 
EGD implementation. 

Driver 3 – Behavioural biases: On one hand, there is still a  global demand for MAPs 
affecting a complete transition to mercury-free alternative. Although the switch is usually 
economically attractive in the medium term, users shy away from the possible high short-
term investment costs. 

23 

 
 
 
 
 
 
 
 
 
 
2.4. 

2.4. Overview of problems and drivers 

Figure 3 below represents the problem tree for the review of the Mercury Regulation. 

Figure 3: The problem tree for the review of the Mercury Regulation 

2.5. 

2.5. Stakeholder views 

Problem  1:  Almost  two-thirds  of  the  consulted  stakeholder  believe  that  an  EU-wide 
discontinuation of dental amalgam would require a general phase-out, while 28% believe 
a gradual phase-down to be chosen by each Member State according to national priorities 
and conditions would be appropriate. Citizens, civil society organisations, environmental 
non-governmental  organisations  (NGOs)  and  associations  of  environmental  dental 
practitioners  broadly  support  the  elimination  of  dental  amalgam  from  the  market  by 
2025. Business associations and dental practitioners pointed out several conditions for an 
efficient  phase-out:  ensuring that the  lower-income population  has  access to  alternative 
solutions  including  a  full  range  of  dental  hygiene  prevention  measures,  promoting 
research  and  innovation  in  chemistry  with  the  aim  to  find  trustworthy  and  sustainable 
alternatives  to  dental  amalgam  and  taking  due  account  of  specific  medical  needs  of 
patients. A handful of organisations voiced concerns about an early phase-out, indicating 
that  trends  in  oral  health  prevention  and  campaigning  may  suffice  to  naturally  reduce 
dental amalgam use.  

Problem  2:  As  regards  mercury  emissions  from  crematoria,  there  is  a  general 
understanding  among  stakeholders  that  they  are  directly  linked  to  the  continued  use  of 
dental amalgam and the majority of respondents to the online public consultation (OPC) 
and  targeted  survey  supported  EU-wide  policy  to  control  mercury  emissions  from 

24 

 
 
 
 
 
 
 
crematoria. One environmental  NGO strongly supported setting mercury  emission limit 
values  for  all  crematoria,  while  one  business  association  recommended  a  flexible 
approach  to  addressing  industrial  emissions  of  mercury,  i.e.,  to  identify  these  specific 
activities  in  which  mercury  remains  essential  in  the  manufacturing  process  while 
promoting the use of BAT within the industrial sector to minimise them. As part of the 
targeted consultation, some stakeholders supported EU limits for all crematoria whereas 
other  stakeholders  expressed  concerns  about  impacts  on  smaller  crematoria  if  EU-wide 
limits were to be established and indicated that less stringent limits could be applied, or 
they could be excluded entirely. 

Problem  3:  Business  associations,  Member  State  authorities  and  NGOs  agree  that, 
within the context of the Minamata Convention, the EU has a responsibility to continue 
showing  global  leadership  in  phasing  out  anthropogenic  sources  of  mercury.  In  this 
respect,  restrictions  on  the  manufacture  and  international  trade  of  MAPs  are  a  key 
element,  in  particular  when  alternatives  are  economically  and  technically  feasible.  All 
NGOs voiced a strong opinion that the EU should stop producing and exporting MAPs, 
which  are  already  banned  on  the  internal  market,  as  this  is  a  practice  that  directly 
contradicts  the  objectives  of  the  EGD.  Business  associations  supported  globally 
harmonised actions but raised doubts about the effectiveness of unilateral EU measures, 
especially in foreign markets with persistent demand in and supply by third countries. 

A full summary of stakeholder activities can be found in Annex 2. 

3.  3.  WHY SHOULD THE EU ACT? 

3.1. 

3.1. Legal basis 

Articles 191 and 192 of the Treaty on the Functioning of the European Union (TFEU)64 
empower  the  EU  to  act  inter  alia  to:  preserve,  protect  and  improve  the  quality  of  the 
environment;  protect  human  health  and  promote  measures  at  the  international  level  to 
deal with regional or worldwide environmental problems. 

3.2. 

3.2. Subsidiarity: Necessity of EU action 

This initiative stems directly from Article 19 of the Mercury Regulation. Paragraph 3 of 
this  provision  stipulates  that  the  Commission  shall,  if  appropriate,  present  a  legislative 
proposal  together  with  its  report  referred  to  in  paragraph  1.  In  that  respect,  the 
Commission Review Report has 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  MAPs,  for  the  purpose  of  protecting  the  environment  and  human  health 
from mercury pollution (see Annex 6). This can be achieved by Member States,  but by 

64   OJ C 326, 26/10/2012.  

25 

 
 
 
 
 
 
 
 
 
                                                           
reason of the nature of the measures to be taken (i.e., uniform prohibition on the use of 
dental amalgam, alignment of EU law on MAPs), be better achieved at Union level.   

3.3. 

3.3. Subsidiarity: Added value of EU action 

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. Furthermore, as explained in 
sub-section  1.1  of  this  document,  this  initiative  will  contribute  to  the  meeting  of  the 
objectives of the EGD and, in particular, of the ZPAP.  

Additionally,  action  at  Union  level  would  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  would  enable  concerned  individuals  and  legal 
persons to ascertain the full extent of their rights and obligations.  

The EU has  always  been an instrumental player at  global  level,  advocating the  gradual 
and rapid phase-out of all mercury production, use and trade.  EU action, law and policy 
that  is  coherent  with  this  policy  will  therefore  strengthen  the  credibility  of  the  EU  and 
generate a positive impact  on health and environment at international level and in third 
countries.  

4.  4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

4.1. 

4.1. General objectives 

The  general  objective  of  this  initiative  is  to  close  remaining  gaps  in  EU  mercury 
legislation  to  further  contribute  to  the  objectives  of  (i)  the  Minamata  Convention  by 
protecting  human  health  and  the  environment  from  mercury  pollution,  (ii)  the  G7 
decarbonisation agenda by ensuring more energy efficient lighting products and (iii) the 
EGD aiming for a non-toxic environment  and protecting natural  ecosystems  and public 
health from the adverse effects of mercury pollution at EU and global level. 

4.2. 

4.2. Specific objectives 

The initiative aims  to  address  the harmful  impacts on health and the environment  from 
mercury  pollution  currently  not  regulated  or  insufficiently  regulated  by  the  Mercury 
Regulation, to prevent, or at least minimise, the emissions of mercury and its compounds 
from dentistry, crematoria and the production and use of MAPs. There are three specific 
objectives logically linked to the two problem areas and their respective drivers: 

Objective  1  (Dental  amalgam  use):  Phase-out  the  use  of  dental  amalgam  in  the  EU 
whilst ensuring access of individuals to affordable mercury-free alternatives in relation to 

26 

 
 
 
 
 
  
 
 
 
 
 
 
oral health and consumer rights, in order to eliminate exposure and risks associated with 
dental amalgam. 

Objective  2  (crematoria  emissions):  Reduce  emissions  from  crematoria  to  levels  no 
longer considered harmful to human health and natural ecosystems, taking full account of 
the subsidiarity and proportionality principles. 

Objective  3  (mercury-added  products  for  export  to  third  countries):  Eliminate  the 
manufacture and export  of a variety of MAPs, with a view to reducing  global mercury 
consumption and ensuring that the EU leads by example and align the EU acquis on the 
placing on the market, import, export and manufacturing of MAPs, thereby simplifying 
Union  legislation  and  providing  greater  legal  certainty  for  all  stakeholders,  including 
relevant industrial sectors. 

5.  5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? 

5.1. 

5.1. What is the baseline from which options are assessed? 

This section summarises the detailed description and discussion of the baseline provided 
in  Annex  5.  The  baseline  implies  the  continuation  of  the  existing  legal  framework  and 
scope. An assessment was  made to  evaluate  whether and  to  what  extent the baseline is 
dynamic  for  each  of  the  three  problem  areas,  taking  full  account  of  the  increased 
awareness  of  mercury  and  its  associated  environmental  and  health  risks.  The  key 
parameters of the baseline are depicted, by problem area, in the following sub-sections. 

5.1.1.  5.1.1. Dental Amalgam 

Decayed, Missing and Filled Teeth (DMFT) index 

To develop a baseline for dental amalgam use in the EU, the DMFT epidemiologic index 
was used as the predominant population-based measure of caries experience worldwide. 
This index gives the sum of an individual’s decayed, missing and filled permanent teeth 
for different age groups and for specific years (2000, 2005, 2015, and 2030). Thanks to 
this  model  (outlined  in  Annex  5),  the  state  of  dental  health  in  the  EU  in  2019  was 
calculated  and the DMFT  index for all ages  for  all Member States was determined. To 
further develop the baseline, three sets of data were necessary to estimate the quantity of 
mercury used for the treatment of dental cavities: 

Mercury content of dental amalgam capsules 

Since 1 January 2019, dental amalgam is only allowed to be used in the EU in pre-dosed 
encapsulated from  and the use of bulk mercury is prohibited. Dental amalgam  capsules 
are round-ended plastic cylinder containing amalgam alloy and mercury. The content of 
mercury in  dental amalgam  capsules was identified for different  types of capsules. The 
baseline assumes a total mercury content of amalgam capsules of ~590 ± 110 mg.  

27 

 
 
 
 
 
 
 
 
 
 
 
 
Share of dental amalgam use 

The share of dental amalgam use per Member State was approximated using a variety of 
data sources. The data  clearly shows the difference in  the share of dental amalgam  use 
across Member States ranging from 0% to over 50%. The share of dental amalgam use 
per Member State is available in Annex 5 and includes baseline projections for 2030. 

Share of dental amalgam capsules placed in the tooth 

The share of dental amalgam capsule content put in patients’ teeth was estimated to range 
from 26% to 66%65 which would represent a range of 125 mg to 462 mg per filling. 

Using the above information in combination with the population data from Eurostat for 
2019 with projections to 2030 and the DMFT estimates for all Member States for 2019 
and  2030,  it  was  possible  to  estimate  the  quantities  of  mercury  used  in  the  EU  due  to 
dental amalgam use in 2019 and 2030. 

The mean total mercury used in dental amalgam in the EU (Figure 4) is estimated to be 
40.4 t in 2019 (of which 18.6 t are placed in teeth and 21.8 t are wasted) (with the lower 
estimate  being  31.6  t  and  the  upper  estimate  being  50.3  t).  Mercury  use  is  expected  to 
decrease to  11.2  t  by 2030  (with the lower estimate being  7.1  t  and the upper estimate 
being  16.8  t).  The  use  of  dental  amalgam  is  projected  to  be  nearly  totally  phased  out 
(reduced to 0.16 t) by 2035, subject to Member States continuing to reduce such use at a 
similar rate to the previous 10 years (which is not guaranteed). This reduction is mirrored 
by a decline in the number of manufacturers producing dental amalgam. In the EU, only 
four (out of nine) dental amalgam manufacturers (NL, ES, CZ, IT) remain to date, who 
also produce a variety of mercury-free dental filling materials. 

Figure 4: Baseline projections for dental amalgam use (EU27) 

65   Drummond, James L. et al. "Mercury Generation Potential From Dental Waste Amalgam". Journal Of 
Dentistry,  vol  31,  no.  7,  2003,  pp.  493-501.  Elsevier  BV,  doi:10.1016/s0300-5712(03)00083-6. 
Accessed 29 Mar 2022. 

28 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
The figures obtained for mercury use in dental amalgam in the different Member States 
in  2019,  2025  and  2030  can  be  found  in  Table  1  above  (uncertainties  and  assumptions 
made during the quantification of mercury use in the EU are available in Annex 5). 

Emissions from dental amalgam 

Dental  amalgam  use  (including  wasted  amalgam)  in  2019  and  2030  (as  part  of  the 
baseline) as well as their estimated emissions are presented in Table 7 below. 

Table 7: Total dental amalgam inputs and outputs (2019 and 2030) 

Fate of Dental Amalgam (DA) 

T of Hg per year (2019) 

T of Hg per year (2030) 

TOTAL DA INPUTS 

Total DA 

DA used in restorations 

DA to waste 

TOTAL DA OUTPUTS 

Emissions to 
air 

Emissions to 
water66 

Discharged 
to 

40.4 

18.6 

21.8 

1.3 

0.3 

1.1 

66 Refers to discharges direct to the aquatic environment. 

29 

11.2 

5.2 

6.0 

0.4 

0.1 

0.3 

 
 
 
 
 
 
 
 
                                                           
Fate of Dental Amalgam (DA) 

T of Hg per year (2019) 

T of Hg per year (2030) 

wastewater67 

Emissions to 
soil 

Sequestered 
or recycled 

1.4 

17.8 

0.4 

4.9 

Any mercury used in dental amalgam will, in the short, medium or long-term, enter the 
environment via various pathways (see Figure 5). 

Figure 5: Fate of mercury and flows into the environment resulting from dental amalgam 
use (2019) 

67 Refers to discharges to wastewater streams, ultimately reaching wastewater treatment plants. 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
Additionally,  the  releases  of  mercury  to  the  environment  in  2019  as  a  result  of  dental 
amalgam  in  deceased  people’  mouths  are  displayed  in  Figure  6.  These  emissions  are 
displayed separately from the releases from dental use, as the former account for legacy 
mercury (i.e., mercury in dental amalgam restorations fitted in patients’ teeth in 2019 as 
well as previous years), while the latter only account for releases in 2019 (i.e., mercury 
used in restorations fitted in patients’ teeth in 2019 only). 

Figure 6: Fate of mercury and flows into the environment resulting from dental amalgam in 
deceased people (2019) 

The  three  phase-out  scenarios  assessed  within  this  Policy  Option  would  reduce  these 
environmental releases to zero as the underlying source, continued dental amalgam use, 
is eliminated, except in the few cases where such a use will remain justified to address 
specific medical conditions.  

31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.1.2.  5.1.2. Emissions 

from 

crematoria 

Estimated emissions for individual Member States in 2019 and in 2030 are presented in 
Annex 5. Total mercury emissions are estimated at 0.69 t in 2019. Emissions in 2030 are 
estimated at 0.36 t. All Member States are predicted to see a decline in emissions over 
this  period  as  a  result  of  declining  use  of  dental  amalgam  in  the  baseline.  Figure  7 
displays the predicted evolution of mercury emissions from crematoria under the baseline 
scenario.  

Figure 7: Baseline projections for mercury emissions from crematoria (EU27) 

These figures (for 2019) are lower than those reported by the Member States under the 
CLRTAP as set out in Section 2.2 and Figure 1. It is likely that the emissions inventory 
data reported under the  CLRTAP are largely derived using a top-down approach based 
on  a  simplified  approach.  In  defining  the  baseline  for  this  assessment,  a  bottom-up 
approach  to  quantifying  emissions  has  been  adopted  which  is  considered  more 
representative.  This  involved  exploring  trends  and  activity  levels  in  the  underlying 
drivers in order to build up to an estimate of crematoria emissions as well as considering 
existing controls already applied in some Member States. 

In constructing a baseline, four underlying drivers were considered separately before they 
were  drawn  together  to  estimate  crematoria  emissions.  The  framework  for  combining 
these  separate  factors  into  a  quantified  reference  scenario  of  mercury  emissions  from 
crematoria  is  set  out  in  Annex  5.  In  addition,  for  the  analysis  of  impacts  of  different 
policy  options,  a  dynamic  baseline  has  been  developed  with  or  without  a  phase-out  of 
dental amalgam (being considered as part of Problem 1).  

32 

 
 
 
 
 
 
 
 
Note:  All  impacts  of  Policy  Options  addressing  mercury  emissions  from  crematoria  in 
subsequent  sections  are  assessed relative to  a baseline assuming no phase-out  of dental 
amalgam. However, such a phase-out would have significant impacts on the effectiveness 
and  efficiency  of  PO3  and  PO4a  and  b,  i.e.,  considering  that  the  average  lifetime  of 
dental  amalgam  fillings  is  15  to  20  years,  a  phase-out  in  2025  would  mean  that  most 
dental  amalgam  will  be  removed  from  people’s  mouths  by  2045,  hence  decreasing  the 
amount of mercury reaching crematoria. The combined impact of PO3 or PO4a and b and 
a phase-out of dental amalgam are therefore considered in the assessment (Section 6) and 
comparison of options (Section 7). 

Annual cremation rates per Member State 

Data  for  each  Member  State  were  obtained  from  the  Cremation  Society  for  the  period 
2010 to 2019 where available. These were used to extrapolate historical trends to a future 
baseline  year of 2030 using a linear  regression (see Annex 5). The projected cremation 
rates  from  2019  to  2030  show  an  overall  increased  trend  across  the  EU  with  some 
Member  States  expected  to  experience  a  significant  rise  in  cremation  rates  e.g., 
Germany’s  cremation  rates  rising  to  above  97%  in  2030  and  Poland’s  cremation  rate 
doubling to reach 61% in 2030. Targeted stakeholder feedback also confirmed an overall 
increasing trend in numbers of cremations.  

Complete data are available only up to the year 2019 and therefore do not reflect the very 
sad  and  sudden  increase  in  mortality  rates  brought  about  by  the  COVID-19  pandemic. 
Limited  data  on  2020  cremation  rates  in  some  Member  States  were  accessed  during 
targeted stakeholder consultation.68 Although most cremation rates had increased in 2020 
in  comparison  to  2019  rates,  the  amount  by  which  they  increased  varied  greatly,  and 
some Member States even saw modest decreases in cremation rates (NL and SE). Large 
increases between 2010 and 2019 were seen in BE (58% increase), IE (75% increase) and 
IT (47% increase). Most other Member States for which data is available saw an increase 
closer to 5-7% from 2019 rates. However, it is expected that as the pandemic diminishes, 
cremation rates will return to pre-pandemic trends. Consequently, future projections are 
based solely on pre-pandemic trends. 

Total corpse mercury content 

The mercury content for corpses in different age bands was calculated for each Member 
State.  This  was  based  on  (i)  the  mean  number  of  decayed,  missing  and  filled  teeth 
(DMFT) for each age group; (ii) the relative share of amalgam use in dental restorations 
and  (iii)  the  typical  mercury  content  of  a  dental  amalgam  filling.  Details  on  this 
methodology are set out in Annex 5, which links the baseline for crematoria with the one 
on dental amalgam.  

Uptake of emissions abatement technologies 

68   2020 cremation rates for BG, CZ, DE, DK, EL, FI, HU, IE, LT, NL, PT, SE and SL were provided via 

direct correspondence with the International Cremation Federation on 25th July 2022.  

33 

 
 
 
  
 
 
 
 
 
 
                                                           
Historical data on uptake of emissions abatement systems at crematoria are limited and it 
was not possible to obtain any further information through the stakeholder survey; it was 
therefore not possible to  robustly  project  uptake  trends  into the future.  It was therefore 
assumed  that,  under  a  business-as-usual  baseline  scenario,  future  uptake  of  abatement 
systems would remain at the same level as current levels (presented in Annex 5). 

Mercury removal efficiency of abatement systems 

For  this  assessment,  it  has  been  assumed  that  100%  of  mercury  reaching  crematoria  in 
corpses  is  emitted  to  air  during  cremation.  This  assumption  is  considered  an  accurate 
approximation  of  operating  conditions69.  Data  collated  from  the  literature  on  mercury 
removal  efficiencies  for  the  most  widely  used  abatement  technologies  are  presented  in 
Annex 5. 

Where no further country-specific removal efficiency could be obtained, an upper value 
of 99.9% was assumed along with a lower value of 90% and a central value of 95%. This 
is based on reported removal efficiencies for carbon injection and solid bed filtration, the 
most widely used abatement technologies. 

5.1.3.  5.1.3. Mercury-added 

products  for  export  to  third 
countries 

Based  on  the  problem  description,  three  groups  of  MAPs  have  been  selected  as  they 
constitute  the  vast  majority  of  MAPs  both  in  number  and  value  currently  being 
manufactured and exported from the EU. 

  Dental amalgam 
  CFLs for general lighting purposes 
  Double  capped  hot  cathode  fluorescent  lamps  for  general  lighting  purposes 

(mainly LFLs) 

The  baseline  scenario  aims  to  provide  a  reference  point  against  which  the  potential 
impacts of an EU-wide manufacture and export prohibition can be assessed. This requires 
a reasonable estimation of the current manufacture in the Union and export from the EU 
of  MAPs.  Third  countries’  legal  regimes,  national  programmes  and  initiatives  that  will 
lead to a change in demand of products exported from the EU were analysed and  taken 
into account. 

A baseline scenario was developed, which assumes:  

  No further legal actions in the EU beyond those already agreed or planned to take 

place,  

69   Piagno and Afshari (2020). Mercury from crematoriums: human health risk assessment and estimate of 

total emissions in British Columbia. https://doi.org/10.17269%2Fs41997-020-00327-0 

34 

 
 
 
 
 
  
 
 
 
 
 
                                                           
  The  impact  of  national  measures  in  importing  third  countries  in  response  to 

restrictions already laid down in EU law.  

The baseline does not include the additional mercury-containing lamps (triband phosphor 
lamps and halophosphate lamps), for which Parties decided to defer to COP5 the possible 
decisions on their phase-out dates (2025, 2027 or 2030), since it entails a relatively high 
level  of  uncertainty  in  terms  of  outcome.  COP  Decisions  to  determine  if,  when  and  to 
what extent a specific MAP will be restricted under the Minamata Convention are not in 
the  hands  of  the  EU  alone.  In  practice,  consensus  needs  to  be  reached  among  all  139 
Parties  whose  national  interests  in  this  matter  may  vary  significantly  and  where  major 
economies can show strong resistance. 

For the baseline scenario, future exports of relevant MAPs in terms of number, value, and 
mercury content were estimated based on identified current and past trends. 
Predicted export volumes for 2025 and 2030 

Regarding  dental  amalgam  and  considering  the  expectations  expressed  in  a  WHO 
study70 (75% of participants foresaw a phase-out by 2030) and data on declining use in 
the USA and Canada, it is expected that the demand for EU-made encapsulated amalgam 
will decrease and that exports will decrease by 25% to 75% of the current levels by 
2030.  The  already  large  uncertainty  concerning  current  dental  amalgam  exports  only 
allows a rough calculation of the order of future export volumes. The mercury content of 
these  exports  is  estimated  to  range  from  13-55  million  capsules  with  a  total  mercury 
content of 7-32 t in 2025 and 5-48 million capsules with a total mercury content of 3-28 
t in 2030. 

Regarding other MAPs (more specifically, mercury-containing lamps), the projected 
exports (in terms of units) for the baseline is summarised in Annex 5. For the baseline, it 
is  expected  that,  by  2025,  export  volumes  for  all  CFLs  and  LFLs  would  fall  to 
around 83-141 million units. By 2030, the numbers would fall to between 49 and 83 
million units. The calculated decrease is stronger for CFL lamps. In comparison to 2020, 
exports are predicted to decrease by 47-68%. 

The value of all above-mentioned exported lamps decreases from €92.2 million (2020) to 
approx. €59 million by 2025 and to approx. €29 million by 2030. 

Due to an increased shift towards LED lamps, in the EU, there are only four remaining 
manufacturers  (the  two  largest  are  located  in  DE  and  PL)  that  continue  to  produce 
mercury-containing lamps, although even their production lines are increasingly focused 
on the production of LEDs. One of the four plants (located in HU) has already announced 
its closure by the end of 2022.  The amount of mercury exported via CFLs and LFLs is 
estimated at 450-501 kg in 202071. This quantity would decrease to about 245-414 kg by 

70    WHO  (2021)  Report  of  the  informal  global  WHO  consultation  with  policymakers  in  dental  public 

health, 2021: monitoring country progress in phasing down the use of dental amalgam 

71  This value was calculated on basis on of available information on the mercury content per lamp in 2022. 

The actual value in 2020 was probably higher. 

35 

 
 
 
 
 
 
 
 
                                                           
2025 and to about 146-246 kg by 2030. The wide range follows from the uncertainty of 
the average mercury content of the exported lamps. 

5.2. 

5.2. Description of the policy options 

The policy options have been developed from the list of potential policy measures, which 
were  identified  based  on  the  findings  of  Commission  Review  Report  and  input  from 
Member  States  and  stakeholders.  These  measures  were  screened  to  identify  those  that 
should be retained for further analysis.  

The screening process  resulted in  a  list  of 13 measures  retained for impact  assessment, 
including  three  for  dental  amalgam,  six  for  crematoria  emissions  and  four  for  MAPs. 
After impact assessing all policy options, six were retained (two for dental amalgam, two 
for  crematoria  emissions  and  two  for  MAPs).  Whilst  most  are  relatively  independent 
from  each  other,  some  of  them  contribute  to  several  specific  objectives.  Others  are 
mainly relevant for a single objective. Annex 7 contains the list of measures which were 
screened out, as well as the rationale for not retaining them. 

Problem 1: Health and environmental risks associated with the use of dental amalgam 

Policy Options for Problem 1 are mapped below in Figure 8. 

Policy Option 1 (PO1) – Dental health communication campaigns: It may provide for 
several information campaigns to improve the knowledge and understanding of patients 
and healthcare practitioners, such as: 

  A  patient  awareness  campaign  on  the  current  knowledge  of  the  risks  associated 

with amalgam and the indications for the removal of old amalgam 

  A campaign to evaluate current professional practices in relation to monitoring of 

urinary mercury in health professionals 

  The continuation of training for future practitioners on the risks associated with 

removal of dental amalgam and related waste management beyond 2030 

Policy  Option  2  (PO2)  –  Establish  a legally  binding  end date  for  the  use  of dental 
amalgam  in  the  EU:  This  option  foresees  an  amendment  of  the  Mercury  Regulation 
establishing  a  legally  binding  phase-out  of  dental  amalgam  use  in  the  EU.  The  exact 
impacts  of  PO2  would  depend  on  the  timelines  of  the  EU-wide  ban,  and  the  following 
scenarios have been assessed: 

  PO2a: a phase-out with a 2025 deadline 
  PO2b: a phase-out with a 2027 deadline 
  PO2c: a phase-out with a 2030 deadline 

Note: This Policy Option would not affect the existing derogation set out under Article 
10(2) of the Mercury Regulation  allowing continued use of dental amalgam in the very 
few  cases  where  the  dental  practitioner  deems  it  strictly  necessary  to  treat  specific 
medical  conditions  (e.g.,  allergies).  Considering  that  this  option  would  prohibit  the  use 

36 

 
 
 
 
 
 
 
 
 
 
 
 
(PO2) and manufacture and export of dental amalgam (PO6 below) in the Union, dental 
amalgam required to address those limited specific cases would either be imported and/or 
sourced from existing stocks in the EU.  

Figure 8: Mapping of policy options addressing the continued use of dental amalgam 

Problem  2:  Health  and  environmental  risks  associated  with  mercury  emissions  from 
crematoria 

Policy Options for Problem 2 are mapped below in Figure 9. 

Policy  Option  3  (PO3)  –  Guidance  on  abatement  technology:  It  provides  for  EU 
guidance  on  abatement  technology  for  controlling  mercury  emissions  from  crematoria, 
including  adsorption  techniques.  Such  guidance  could  describe  various  available 
abatement techniques and the costs associated with installing, operating and maintaining 
these, taking into account the existing OSPAR and HELCOM recommendations. 

37 

 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
Policy  Option  4  (PO4)  -  Mandatory  abatement  of  mercury  emissions:  provides  for 
EU-wide  mandatory  application  of  abatement  technology  using  BAT.  A  number  of 
routes to delivering PO4 have been assessed72: 

  PO4a  –  Abatement  for  all  crematoria:  assumed  to  deliver  a  100%  uptake  in 

emissions abatement systems in all crematoria across the EU. 

  PO4b – Abatement for large crematoria: only crematoria above a certain number 
of cremations per year would be required to install abatement. The threshold is set 
at  ≥4,000  based  on  Table  9  (below)  that  shows  that  below  this  threshold  the 
benefits to cost-ratio falls rapidly under breakeven point. 

  PO4c – Abatement for large crematoria: only crematoria above a certain number 
of cremations per year would be required to install abatement. The threshold is set 
at ≥ 3,000 based on Table 9 (below). 

Figure 9: Mapping of policy options addressing mercury emissions from crematoria 

Problem  3:  Health  and  environmental  risks  associated  with  MAPs  manufactured  in 
and exported from the EU   

Policy Options for Problem 3 are mapped below in  

72   Best  Available  Technique  (BAT)/Associated  Emission  Levels  (AELs),  Mercury  benchmarks  / 

reduction targets, Burden-sharing agreements, National mercury reduction commitments. 

38 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
Figure 10 10. 

Policy Option 5 (PO5) - Global agreement: It addresses the continued manufacture in 
and export from the EU of dental amalgam and concerned mercury-containing lamps by 
seeking international agreement, under the Minamata Convention, to prohibit it. The EU 
would need to negotiate and achieve global agreement on amendments to Annex A of the 
Convention,  which  lists  MAPs  and  sets  deadlines  after  which  the  manufacture,  export 
and import of the concerned MAPs is no longer allowed. Implementation of such a global 
agreement  into  EU  law  could  then  be  done  by  amending  the  Mercury  Regulation  via 
Delegated Acts (in line with its Article 20). 

Policy Option 6 (PO6): EU ban on MAPs: It assesses the possibility of introducing an 
EU-wide ban on manufacturing and exporting  dental amalgam and concerned mercury-
containing  lamps. Two timeframes  were considered by  which  such EU-wide  ban could 
enter into force:  

  PO6a: 2025  
  PO6b: 2026/2028 based on the earliest phase-out dates retained for negotiations 
at  the  next  Conference  of  the  Parties  to  the  Minamata  Convention  (COP5) 
(further  described  in  Annex  8,  2026  for  halophosphate  LFLs  and  2028  for  all 
other considered lamp types) 

Figure 10: Mapping of policy options addressing the manufacture and export of MAPs 

39 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.  6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? 

This section presents an assessment of the impacts of all options against the baseline. As 
options and sub-options are packages of measures, the impact assessment builds on the 
assessment of the impacts of the individual measures, which is available in Annex 8.  

6.1. 

6.1. Problem 1 – dental amalgam use  

6.1.1.  6.1.1. Analysis 

Policy 
Option  1  –  Dental  health 
communication campaigns 

of 

Economic impacts 

The impact of the measures taken by Member States under PO1 is expected to be positive 
regarding  employment.  Jobs  may  first  be  created  for  organising  awareness-raising 
activities, although these jobs may use the existing personnel or temporary ones created 
only  for  a  short  period.  Jobs  may  also  be  created  to  train  dentists  in  mercury-free 
restoration techniques. Finally, as this option is expected to foster innovation in mercury-
free  filling  materials,  it  may  also  generate  new  employment  opportunities  in  R&D 
activities within the dental industry. 

Environmental impacts 

The  non-mandatory  nature  of  this  option  makes  it  difficult  to  quantify  the  potential 
human health impacts. Any reduction in the use of dental amalgam would result in direct 
health benefits from reduced patient exposure to mercury. It would also result in reduced 

40 

 
 
 
 
 
 
 
 
 
 
 
emissions of mercury to the environment from both direct (dental practices) and indirect 
sources  (including  crematoria  emissions)  and  would  reduce  public  environmental 
exposure to mercury. The voluntary character of the option however means that there is 
no certainty regarding environmental and health benefits. 

Social impacts 

The impact of health improvement campaigns cannot be measured in absolute magnitude 
but  on  the  degree  of  their  effectiveness.  For  such  campaigns,  studies  have  highlighted 
various  aspects  of  socio-economic  inequality,  which  will  impact  their  effectiveness, 
including coverage of state social security, patient income disparities, and dependence on 
public versus private dental insurance. 

Stakeholder views 

About  89%  of  the  stakeholders  who  responded  to  the  OPC,  including  almost  all 
companies and business  associations, believe that dental health in the EU could still be 
improved.  Such  improvement  can  be  achieved  by  a  continuous/further  expansion  of 
prevention  measures  at  the  national  level,  in  which  communication  campaigns  play  a 
significant  role. Stakeholders also  believed  corresponding developments  can already be 
seen in Member States that have increased their focus on prevention.   

6.1.2.  6.1.2. Analysis 

of 

Policy 
Option 2 – Establish a legally 
binding end date for the use of 
dental amalgam in the EU  

Economic impacts 

Conduct of business: Considering that six out of the nine manufacturers have already (or 
will soon) discontinue the production of dental amalgam, the impact of a dental amalgam 
phase-out would be limited to those few remaining manufacturers (SME’s). For some of 
these  remaining  manufacturers,  existing  certificates  issued  under  the  previous  Medical 
Device  Directive  93/42/EEC73  were  due  to  expire  on  31  December  2028  in  accordance 
with the new Medical Device Regulation EU 2017/74574. No information on whether any 
of  these  manufacturers  have  sought  to  apply  for  new  certificates  under  this  Regulation 
has been identified.  

The extent of potential adverse effects on those manufacturers will therefore depend on 
the  share  of  dental  amalgam  in  their  overall  production  and  the  capacity  to  switch 
production  lines  to  mercury-free  alternatives.  Although  the  four  remaining  EU  dental 
amalgam  manufacturers  are  considered  SMEs,  available  information  suggests  that  they 

73   Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). 
74   Regulation (EU) 2017/745 of the European Parliament and of the Council of  5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 

41 

 
 
 
 
 
 
 
 
 
 
                                                           
do  not  rely  solely  on  the  production  of  dental  amalgam  but  also  produce  mercury-free 
alternatives  and  other  medical  devices.  Although  information  is  limited  for  this  sector, 
the  small  number  of  remaining  EU  manufacturers  and  their  capacity  to  shift  to  other 
product  lines  implies  a  limited  economic  impact  of  a  manufacture  and  export  ban. 
Companies with a high share of mercury-free materials in their production will gain an 
even more significant competitive advantage.  

Although  dental  practices  are  considered  micro-enterprises,  the  associated  costs  of  a 
phase-out of the use of dental amalgam are considered negligible for dentists as the costs 
are passed on to patients (or in some Member States, the re-imbursement schemes). Costs 
incurred by dentists due to the maintenance of amalgam separators and the collection and 
treatment  of  amalgam  waste  as  hazardous  waste  will  not  change  as  legacy  dental 
amalgam will need to be treated. In the short-term, a phase-out scenario may put pressure 
on the few remaining dentists who have limited experience in carrying out mercury-free 
restorations.  On  the  other  hand,  a  phase-out  will  generate  a  competitive  advantage  for 
dentists already fully skilled in mercury-free restoration techniques. 

Consumers  and  households:  Currently,  the  use  of  dental  amalgam  affects  EU  citizens 
mainly  through  their  tax  contributions  to  the  costs  of  managing  mercury-contaminated 
urban wastewater and municipal waste (usually included in local taxes). If the installation 
of separators has not already led to sufficiently low levels of mercury in sewage sludge, 
an amalgam phase-out would ultimately (in the long-term) result in an even lower input 
of  mercury  into  the  wastewater  system.  Overall,  this  will  have  a  positive  economic 
impact  on  municipalities  and  taxpayers,  as  it  will  reduce  the  environmental  costs 
associated with managing mercury pollution from dental amalgam. 

Dental restoration costs borne by the patients depend on four main factors, i.e. (i) the cost 
of  the  filling  material  (negligible  difference  between  dental  amalgam  and  alternatives), 
(ii)  reimbursement  by  the  social  security  and/or  private  medical  insurance,  (iii)  the 
longevity of restorations and (iv) labour cost for the treatment. The difference in cost of 
restorations can vary across the EU (see Table 8 although the data is from 2018 and cost 
differentials  are  expected  to  have  further  narrowed  as  more  Member  States  phase  out 
dental amalgam use and experience with use of alternatives increases). In DK (a Member 
State  with  long-term  experience  with  dental  amalgam  phase-out),  dental  amalgam  use 
decreased to 1.7% by 2017, and the cost difference associated with this shift to mercury-
free alternatives has been estimated to be about €6 per treatment. This figure is therefore 
considered most representative of the cost differential if a full EU phase-out were to be 
applied.  

Table 8: Price difference between dental amalgam and its alternatives per Member State 

Country 

AT 
BE 
BG 
CY 
CZ 

Price per restoration 
(dental amalgam) 
(EUR) 
97.5 
52.5 
13.0 
60.0 
19.2 

Price per restoration 
(alternatives) (EUR) 

Price difference (EUR) 

97.5 
52.5 
13.1 
60.0 
19.3 

42 

0 
0 
0.1 
0 
0.1 

 
 
 
 
 
 
 
Country 

DE 
DK 
EE 
ES 
FI 
FR 
EL 
HR 
HU 
IE 
IT 
LT 
LU 
LV 
MT 
NL 
PL 
PT 
RO 
SE 
SI 
SK 
UK 
EU 28 

Price per restoration 
(dental amalgam) 
(EUR) 
48.2 
54.2 
28.3 
46.1 
50.0 
40.0 
50 
23.0 
20.4 
50.0 
125.0 
19.9 
58.0 
15.0 
70.0 
45.0 
19.0 
33.7 
13.9 
N/A 
26.0 
22.7 
42.7 
40.8 

Price per restoration 
(alternatives) (EUR) 

Price difference (EUR) 

75.0 
60.6 
28.5 
46.1 
50.0 
40.0 
60 
23.2 
20.6 
51.5 
175.0 
20.0 
71.0 
25.0 
70.0 
67.3 
19.1 
33.7 
14.0 
105.0 
48.5 
22.9 
45.8 
50.5 

26.8 
6.4 
0.2 
0 
0 
0 
10 
0.2 
0.2 
1.5 
50 
0.1 
13 
10 
0 
22.3 
0.1 
0 
0.1 
N/A 
22.5 
0.2 
3.1 
9.7 

Based  on  this  information,  the  additional  annual  costs  to  EU  consumers  (i.e.,  national 
care  health  systems)  using  alternatives  in  the  first  year  of  the  phase-out  of  dental 
amalgam (i.e., 2025, 2027 or 2030) are estimated as follows: 

  €208 million in 2025 (with a phase-out in 2025 i.e., PO2a) 
  €170 million in 2027 (with a phase-out in 2027 i.e., PO2b) 
  €114 million in 2030 (with a phase-out in 2030 i.e., PO2c) 

The  cost  of  a  dental  amalgam  phase-out  per  Member  State  is  available  in  Annex  7. 
Considering the difference in the use of dental amalgam across the EU, the distribution of 
these  costs  will  affect  Member  States  differently.  However,  the  economic  impact  of  a 
phase-out of the use of dental amalgam is expected to be minimal compared to Member 
States national healthcare budgets. 

Figure  11  illustrates  that  the  greatest  burden  of  a  dental  amalgam  phase-out  on  the 
national  healthcare budget  may be incurred by  SI,  SK,  BU, and  the  CZ (between 0.4% 
and 0.7% of their national healthcare  budgets). This is based on the assumption that all 
costs  associated  with  a  shift  towards  mercury-free  alternatives  are  covered  by  national 
insurance  schemes.  However,  it  is  likely  that  this  will  not  be  the  case  for  all  Member 
States  where  costs  may  be  shared  over  national  or  private  insurance  schemes  or 
transferred to patients (see Figure 12). 

43 

 
 
 
 
 
 
 
Figure 11: Cost to Member States associated with dental amalgam phase-out (2025, 2027 
and 2030), expressed as a % of national healthcare budgets 

Environmental impacts 

A  phase-out  of  dental  amalgam  would  lead  to  a  sudden  drop  to  zero  of  its  use  in  the 
deadline year. Small amounts of mercury may however still be used to treat patients with 
specific medical conditions.  

The cumulative reductions in mercury used in dental restorations up until the year 2035 
are given below for each of the three phase-out scenarios: 

  PO2a (2025 phase-out): a reduction in mercury use of 114.4 t by 2035  
  PO2b (2027 phase-out): a reduction in mercury use of 75.9 t by 2035  
  PO2c (2030 phase-out): a reduction in mercury use of 29.8 t by 2035  

Previous assessments estimated the total mass of mercury in people’s mouths in the EU-
27  (excluding  Croatia  but  including  the  UK)  at  over  1,000 t75.  The  total  population 

75    European  Commission  (2012).  Study  on  the  potential  for  reducing  mercury  pollution  from  dental 

amalgam and batteries: Final report. 
https://ec.europa.eu/environment/chemicals/mercury/pdf/mercury_dental_report.pdf 

44 

 
 
 
 
 
 
 
 
 
 
 
 
                                                           
mercury load will be declining as a result of existing actions taken by the Member States 
to  eliminate  or  reduce  the  use  of  dental  amalgam.  The  phase-out  scenarios  would 
facilitate a quicker reduction in the population mercury load, although it is not possible to 
reliably quantify this change in reduction. 

The cumulative reductions in environmental releases of mercury up until the year 2030 
resulting from the phase-out scenarios, considering the mass flows set out in Figure 5, are 
displayed in Table 9.  

Table  9:  Cumulative  reductions  in  environmental  mercury  releases  resulting  from  phase-
out scenarios 

Fate of Dental Amalgam 
(DA) 

T of Hg (PO2a 2025 
phase-out) 

T of Hg (PO2b 2027 
phase-out) 

T of Hg (PO2c 2030 
phase-out) 

Emissions to air76 

Emissions to water77 

Discharged to wastewater78 

Emissions to soil 

Sequestered or recycled 

Total 

3.1 

0.6 

2.6 

3.4 

42.1 

51.7 

1.3 

0.3 

1.1 

1.4 

17.9 

22 

0.4 

0.1 

0.3 

0.4 

4.9 

6.1 

In  addition,  a  phase-out  of  dental  amalgam  would  result  in  indirect  environmental 
benefits  through  reduced  mercury  emissions  from  crematoria,  although  the  continued 
arrival of mercury to crematoria in ‘legacy’ restorations means that emissions reductions 
would be delayed and would not follow dental amalgam use in immediately dropping to 
zero. Relative to a baseline assuming no EU-level phase-out of dental amalgam, the PO2 
scenarios  are  anticipated  to  have  the  following  impacts  in  terms  of  mercury  emissions 
from  crematoria  in  2030  (relative  to  baseline  emissions  of  355  kg).  The  below  figures 
represent  a  snapshot  of  changes  in  emissions  in  2030,  and  not  cumulative  emissions 
savings over a set period of time. They take account of emissions from ‘legacy’ amalgam 
in old dental restorations, hence continued crematoria emissions even after the phase-out 
of dental amalgam. The figures highlight that an earlier dental amalgam phase-out would 
deliver  much  greater  crematoria  emissions  reductions  sooner  (both  in  2030  and 
cumulatively from the date of a ban). 

  PO2a (2025 phase-out): a reduction in mercury emissions of 54 kg 
  PO2b (2027 phase-out): a reduction in mercury emissions of 31 kg 
  PO2c (2030 phase-out): a reduction in mercury emissions of 3 kg 

Social impacts 

76 Includes emission from crematoria.   
77 Refers to direct discharges to the aquatic environment. 
78 Refers to discharges to wastewater streams, ultimately reaching wastewater treatment plants. 

45 

 
 
 
 
  
 
 
 
 
                                                           
It  is  expected  that  new  jobs  will  be  created  to  train  the  dentists  who  did  not  receive 
training for using alternatives or haven’t practiced it much, some of which will need to 
improve their skills or acquire new skills in mercury-free restoration techniques within a 
short  timeframe.  New  jobs  would  also  be  expected  to  support  R&D  activities  in  the 
dental  fillings  industry  due  to  the  need  for  companies  to  maintain  a  high  level  of 
innovation in mercury-free materials. 

A  phase-out  of  dental  amalgam  is  expected  to  have  both  direct  and  indirect  health 
benefits for EU society. Benefits will be observed for the general population as mercury 
exposure reduction will  likely  lead to lower mercury levels  in  the blood, especially  for 
practitioners,  and  reduction  of  associated  health  risks.  In  particular,  the  greatest  direct 
benefits will be for dental practitioners as they are directly exposed to mercury vapours. 
These benefits are expected to be higher under PO2a as the exposure will cease sooner. 
The  reduction  of  releases  to  water  (e.g.,  via  deposition  from  the  atmosphere  and 
emissions from crematoria) is likely to reduce mercury content in the marine food chain 
and, ultimately in fish, which is directly linked to human exposure to mercury. 

Figure 12 provides an overview of the existing financing structures in the dental sectors 
of a number of Member States, which will likely influence the way in which the costs of 
switching to  mercury-free alternatives  will be distributed. FR and DE have the greatest 
share  of  public  expenditure  in  their  total  dental  expenditure  (>60%),  followed  by  HR, 
BG,  LU  and  SK.  Dental  care  expenditure  in  EL,  ES  and  CY  is  dominated  by  private 
financing,  while  voluntary  health  insurance  schemes  make  up  the  majority  (>60%)  of 
expenditure  in  the  NL.  The  distribution  of  costs  for  dental  amalgam  and  mercury-free 
alternatives per Member State is available in Annex 7. 

46 

 
 
 
 
 
 
Figure 12: Government, voluntary and out-of-pocket spending for dental care as % of total 
dental outpatient curative care expenditure 

Data from the OECD Health Statistics 2022 database. Data for 2020, except for Denmark and the Netherlands (2021 
data), and Malta (2019 data). No data for Portugal, Italy or Ireland. 

Stakeholder views 

Overall,  58%  of  the  consulted  stakeholders  believe  a  phase-out  could  be  achieved  by 
2025 and 22% indicated a phase-out  being achievable by 2030, while 20%  think  that a 
phase-out is not needed, or the proposed years are not appropriate. Among companies or 
business  associations,  65%  and  20%  respectively  believed  that  a  phase-out  was 
achievable by 2025 and 2030 respectively. Of both EU and non-EU citizens’ responses, 
50%  and  29%  respectively  believed  a  phase-out  could  be  achieved  by  2025  and  2030 
respectively.  Four  responses  were  received  from  public  authorities,  two  of  which 

47 

 
 
 
 
 
responded  by  indicating  2025  with  the  other  two  supporting  a  2030  phase-out.  From 
Civil Society stakeholders, 62% and 10% were in favour of a 2025 or 2030 phase-out of 
dental amalgam respectively.   

6.2. 

6.2. Problem 2 – Emissions of mercury from crematoria  

6.2.1.  6.2.1. Analysis 

of 

Policy 
Option 3 – Publication of EU 
emissions 
on 
guidance 
abatement in crematoria 

Economic impacts 

Operating  costs  and  the  conduct  of  business:  The  introduction  of  EU  guidance  on 
emissions  abatement  in  crematoria,  is  not  anticipated  to  have  a  significant  impact  on 
abatement  uptake  in  the  absence  of  supporting  legislation.  Nonetheless,  crematoria 
operators  choosing  to  implement  the  non-legally  binding  guidance  on  information  for 
abatement  would face additional operational  and capital  costs. These vary  according to 
the cremation capacity of the installation. 

  For  PO3  a  5%  increase  in  abatement  uptake  (compared  to  baseline  levels)  is 
assumed  to  occur,  with  no  impact  assumed  to  occur  in  Member  States  where 
guidance or legislation is already in effect. Costs to operators in 2030 relative to a 
baseline assuming no phase-out of dental amalgam are estimated as total one-off 
capital  costs  of  €10.3  million  and  annual  operating  costs  of  €0.32  million 
(equivalent annual costs of €1.08 million). 

Administrative burden on businesses and public authorities: The cremation sector is not 
anticipated  to  incur  any  administrative  burdens  from  the  introduction  of  sector-specific 
guidance.  EU  institutions  producing  the  guidance  and  Member  States’  competent 
authorities  disseminating  these  are  likely  to  face  some  level  of  cost  (albeit  relatively 
limited) in doing so; this would vary depending on the scope of the guidance. 

Position of SMEs: Although more than half of EU crematoria are considered SMEs, the 
associated  costs  of  application  of  BAT  are  considered  to  be  passed  on  to  consumers. 
According  to  available  information  this  is  done  in  most  Member  States  by  using 
environmental  premiums/fees.  Given  the  voluntary  nature  of  the  option,  it  is  not 
anticipated that issuing EU guidance will present significant impacts for SMEs. 

Consumers and households: Given the voluntary uptake of the guidance, it is difficult to 
estimate the additional costs by consumers and households, albeit it can be assumed the 
associated costs of application of BAT would be passed on to them.  

Table 10: PO3 cost-benefit summary table (assuming 5% increase in abatement uptake) 

2030 Cremation capacity 

48 

 
 
 
 
 
 
 
  
 
 
 
 
Total emission reductions (kg) 

Capital costs (€, one-off) 

Operating costs (€, annual) 

Capital and operational costs 
(€, EAC)  
Admin burdens (€, operators 
and authorities) 

Total annual benefits (€, 
central) 
Costs per kg mercury abated 

Net costs / benefits 

<1,00
0 

1,0 

6.465.
662 
201.1
54 
681.4
44 

26.79
5 
682.9
97 
654.6
49 

1,000 - 
2,000 
1,6 

1.020.36
6 
31.745 

2,000 - 
3,000 
4,0 

1.279.04
9 
39.793 

3,000 - 
4,000 
2,7 

4,000 - 
5,000 
2,7 

596.503 

515.258 

18.558 

16.030 

107.541 

134.805 

62.868 

54.305 

Assumed to be zero for PO3 

33.114 

76.565 

51.546 

51.967 

65.879 

33.864 

23.491 

20.045 

74.427 

58.239 

11.322 

2.338 

Benefit-cost ratios 

0,04 

0,31 

0,57 

0,82 

0,96 

>5,0
00 
5,1 

412.
179 
12.8
23 
43.4
41 

Total 

17,1 

10.289.
017 
320.10
3 
1.084.4
04 

96.2
77 
8.57
7 
-
52.8
36 
2,22 

336.26
5 
63.560 

748.13
9 

0,31 

Environmental impacts 

Quality  of  natural  resources:  PO3  is  estimated  to  result  in  a  reduction  in  mercury 
emissions  in  2030  of  around  17  kg  (compared  to  2030  baseline  emissions  of  355  kg). 
Any  reduction  in  mercury  emissions  would  result  in  an  improvement  in  the  quality  of 
natural  resources.  Most  directly,  it  would  result  in  improved  air  quality,  which  would 
indirectly  result  in  reduced  mercury  deposition  to  soil  and  waterbodies.  In  turn,  the 
improved  environmental  quality  would  result  in  further  indirect  human  health  benefits; 
seafood  is  the  primary  source  of  human  exposure  to  mercury,  and  reduced  presence  of 
mercury in environmental media would lead to reduced mercury in seafood consumed by 
populations. 

Social impacts 

Public  health  &  safety  and  health  systems:  Mercury  exposure  is  linked  with  health 
outcomes including cardiovascular mortality, IQ loss in younger age groups, and anemia. 
Based  on  EEA  damage  costs,  the  health  benefits  of  the  mercury  emission  reductions 
outlined in the previous section for 2030 are estimated at around €0.30 million, if applied 
across all crematoria, with the greatest benefit gained through emission reductions among 
crematoria operating at capacities of above 5,000 cremations annually. 

Abatement technology used to reduce mercury emissions also capture a number of other 
pollutants.  In  light  of  this,  human  health  benefits  would  also  be  experienced  through 
reductions  in  PM2.5  emissions  and  other  pollutants  (including  lead,  cadmium,  arsenic, 
chromium, nickel and dioxins and furans) estimated at €36,000 (2030). 

Stakeholder views 

Whilst  no  explicit  feedback  was  received  from  stakeholders  on  a  possible  option 
involving the development of EU guidance, the majority of respondents to the OPC and 

49 

 
 
 
 
 
  
 
 
 
 
 
 
targeted survey supported EU-wide policy to control mercury emissions from crematoria 
although this related more to the establishment of specific limits and application of BAT.  
Policy 
–  Mandatory 
emissions 
of 

6.2.2.  6.2.2. Analysis 
Option 
4 
application 
abatement in crematoria  

of 

Economic impacts 

Operating  costs  and  the  conduct  of  business:  Mandatory  application  of  best  available 
mercury  emission  abatement  techniques  would  entail  additional  capital  costs  to 
crematoria operators from installing abatement systems, and additional operational costs 
from  their  continued  maintenance  and  use.  These  vary  according  to  the  cremation 
capacity  of  the  installation.  Additional  costs  to  operators  in  2030  relative  to  a  baseline 
assuming no phase-out of dental amalgam are estimated as follows: 

  Where PO4a is expected to deliver a 100% uptake of emissions abatement across 
all crematoria in the EU, it is estimated to result in total one-off capital costs of 
€182 million, and annual operating costs of €6 million 

  PO4b  is  expected  to  deliver  a  100%  uptake  of  emissions  abatement  across 
crematoria operating at a capacity of ≥ 4000 cremations per year and is estimated 
to result in total one-off capital costs of €15 million and annual operating costs of 
€0.46 million (see Table 11). 

  PO4c  is  expected  to  deliver  a  100%  uptake  of  emissions  abatement  across 
crematoria operating at a capacity of ≥ 3000 cremations per year and is estimated 
to result in total one-off capital costs of €25 million and annual operating costs of 
€0.78 million (see Table 11). 

Table 11: PO4 cost-benefit summary table 

Total emission reductions 
(kg) 
Capital costs (€, one-off) 

Operating costs (€, annual) 

Capital and operational costs 
(€, EAC)  
Admin burdens (€, operators 
and authorities) 
Total annual benefits (€, 
central) 
Costs per kg mercury abated 

Net costs / benefits 

2030 Cremation capacity 

<1,000 

1,000 - 
2,000 

2,000 - 
3,000 

3,000 - 
4,000 

4,000 - 
5,000 

>5,00
0 

Total 

16,8 

31,3 

75,4 

49,3 

47,4 

93,9 

314,1 

118.67
7.895 
3.692.2
01 
12.507.
980 
564.27
6 
465.51
5 
776.88
3 

12.606.
741 

14.954.
038 

23.816.
566 

10.039.
199 

8.396.8
70 

465.237 

740.960 

312.331 

261.236 

1.576.0
71 

2.510.1
32 

1.058.0
75 

884.983 

6.481.
619 
201.65
0 
683.12
6 

123.601 

115.909 

44.193 

27.425 

23.293 

618.902 

1.450.4
51 

944.566 

902.607 

1.765.
889 

182.36
6.188 
5.673.6
15 
19.220.
367 
898.69
8 
6.147.9
30 

54.321 

34.840 

22.357 

19.257 

7.525 

61.201 

1.080.7
71 

1.175.5
90 

157.702 

9.801 

-
1.059.
470 

13.971.
135 

50 

 
 
 
 
 
  
 
 
Benefit-cost ratios 

0,04 

0.36 

0.55 

0.86 

0.99 

2.50 

0.31 

The greatest costs are incurred among low-capacity crematoria, (below 1,000 cremations 
per  year),  where  the  cost  per  unit  of  mercury  emissions  abated  is  highest.  By 
implementing PO4b with an activity threshold exempting installations below a capacity 
of  4000  cremations  per  year,  the  capital  and  operating  costs  to  business  can  be 
significantly reduced. By implementing PO4c, the capital and operating costs can only be 
slightly reduced. 

A  phase-out  of  dental  amalgam  (PO2a)  in  2025  will  lead  to  a  significant  reduction  in 
mercury emissions from crematoria, decreasing the cost-benefit ratio of PO4 to 0.27 (see 
Table  12).  The  long-term  positive  economic  effect  stemming  from  a  dental  amalgam 
phase-out  will  ultimately  result  in  the  non-necessity  to  install  mercury  abatement 
techniques in new EU crematoria (as only small quantities of dental amalgam would still 
be used within the EU). These benefits will materialize following a delay due to legacy 
dental amalgam (the lag in dental restorations reaching crematoria). 

By  combining  a  dental  amalgam  phase-out  (in  2025)  with  mandatory  abatement  of 
mercury emissions from crematoria: 

  PO4a  is  expected  to  result  in  total  one-off  capital  costs  of  €182  million,  and 

annual operating costs of €6 million 

  PO4b is expected to be cost-beneficial in crematoria operating at a capacity of ≥ 
4000 cremations per year and is estimated to result in total one-off capital costs of 
€15 million and annual operating costs of €0.46 million (see Table 12), covering 
crematoria in 17 Member States (100 crematoria). 

  PO4c is expected to be only marginally cost-beneficial in crematoria operating at 
a capacity of ≥ 3000 cremations per year and is estimated to result in total one-off 
capital costs of €25 million and annual operating costs of €0.78 million (see Table 
12), covering crematoria in 18 Member States (170 crematoria). 

Table 12: PO4 cost-benefit summary table assuming a dental amalgam phase-out in 2025 

Total emission reductions 
(kg) 
Capital costs (€, one-off) 

Operating costs (€, annual) 

Capital and operational 
costs (€, EAC)  
Admin burdens (€, operators 
and authorities) 
Total annual benefits (€, 
central) 
Costs per kg mercury abated 

2030 Cremation capacity 

<1,000 

1,000 – 
2,000 

2,000 – 
3,000 

3,000 – 
4,000 

4,000 – 
5,000 

>5,00
0 

Total 

15,7 

29,2 

68,2 

43,0 

37,8 

75,0 

268,9 

118.67
7.895 
3.692.2
01 
12.507.
980 
564.27
6 
444.89
5 
835.03
2 

14.954.0
38 

23.816.5
66 

10.039.1
99 

8.396.87
0 

465.237 

740.960 

312.331 

261.236 

1.576.07
1 

2.510.13
2 

1.058.07
5 

884.983 

123.601 

115.909 

44.193 

27.425 

581.988 

1.324.68
3 

834.310 

733.157 

6.481.
619 
201.6
50 
683.1
26 
23.29
3 
1.433.
862 

182.36
6.188 
5.673.6
15 
19.220.
367 
898.69
8 
5.352.8
95 

58.225 

38.490 

25.612 

24.168 

9.417 

71.485 

51 

 
 
 
 
 
 
 
 
 
Net costs / benefits 

12.627.
361 

1.117.68
4 

1.301.35
8 

267.958 

179.252 

Benefit-cost ratios 

0,03 

0,34 

0,50 

0,76 

0,80 

-
727.4
43 
2,03 

14.766.
170 

0,27 

Position of SMEs: Implementing the measure with no, or a low, activity threshold would 
incur substantial costs to smaller installations. Some stakeholders indicated that there is 
potential  movement  away  from  significant  public  sector  involvement  in  operation  of 
crematoria to greater involvement from private enterprises. Limited data are available on 
the  structure  of  the  sector  across  the  EU,  but  there  are  likely  to  be  SMEs  involved, 
especially  in  Member  States  dominated  by  smaller  crematoria  (including  ES  and  FR). 
The  implementation  of  no  activity  threshold  is  likely  to  have  greater  implications  for 
SMEs within the sector, who would bear higher costs. However, according to available 
information,  these  costs  are  passed  on  (in  full  or  in  part)  to  consumers  by  using 
environmental premiums/fees and thus impacts on crematoria are expected to be limited. 

Administrative  burden  on  businesses  and  public  authorities:  In  addition  to  the  costs  of 
implementing and operating mercury emissions abatement systems at their installations, 
crematoria operators would face added administrative burdens. This would arise from the 
need  to  submit  information  on  their  abatement  systems  and  any  periodic  emissions 
monitoring  and  reporting  to  Member  States’  competent  authorities,  who  would  also 
encounter a new administrative burden in processing such information. It is assumed that 
costs  to  both  operators  and  authorities  would  be  comparable  to  administrative  burdens 
incurred  by  the  smallest  medium  combustion  plants  (1-5  MWth)  under  Directive  (EU) 
2015/2193 on medium combustion plants79. Administrative costs are estimated to amount 
to €400,000 to operators and €500,000 to authorities for PO4a (all crematoria), €23.000 
to  operators  and  €28.000  to  authorities  for  PO4b  (crematoria  greater  than  4,000 
cremations  per  year)  and  €42.000  to  operators  and  €53.000  to  authorities  for  PO4c 
(crematoria greater than 3,000 cremations per year) in 2030.  

Consumers and households: Crematoria operators implementing abatement technologies 
are likely to pass some or all of the capital and operational costs on to consumers, who 
would  ultimately  pay  more  for  the  same  services.  The  degree  to  which  costs  would  be 
passed on is not known. 

Environmental impacts 

Quality of natural resources: PO4a is anticipated to result in emissions abatement uptake 
of  100%  across  EU  crematoria,  mercury  emissions  reductions  are  estimated  at  314  kg 
(compared  to  a  baseline  of  355 kg),  assuming  no  activity  threshold  (PO4a),  141  kg 
(compared  to  a  baseline  of  355  kg)  with  an  activity  threshold  of  4,000  cremations  per 

79   Directive (EU) 2015/2193 of the European Parliament and of the Council of 25 November 2015 on the 
limitation  of  emissions  of  certain  pollutants  into  the  air  from  medium  combustion  plants  (OJ  L  313, 
28.11.2015, p. 1–19). 

52 

 
 
 
 
 
 
 
 
                                                           
 
year (PO4b) and 191 kg (compared to a baseline of 355 kg) with an activity threshold of 
3,000 cremations per year (PO4c). 

If  PO4  is  combined  with  a  dental  amalgam  phase-out  in  2025  (PO2a),  its  efficiency 
would  decrease.  It  is  anticipated  that  resulting  emission  reductions  would  be  269  kg 
(compared  to  a  baseline  of  301  kg)  assuming  no  activities  threshold  (PO4a),  113  kg 
(compared  to  a  baseline  of  301  kg)  with  an  activity  threshold  of  4,000  cremations  per 
year (PO4b) and 156 kg (compared to a baseline of 301 kg) with an activity threshold of 
3,000 cremations per year (PO4c). 

Any  reduction  in  mercury  emissions  would  result  in  an  improvement  in  the  quality  of 
natural  resources  through  improved  air  quality  and  subsequently  reduced  deposition  to 
soil  and  waterbodies.  Reduced  emissions  to  air  from  crematoria  can  be  quantified  and 
valued using damage cost functions. For other releases / sources (e.g., to water) there is 
no robust way of quantifying and valuing such changes in releases. Following decreasing 
mercury  use  in  dentistry,  extra  operational  costs  will  decrease  with  time,  albeit  slowly 
due to the lifetime of dental amalgam restorations and time it takes for it to be removed 
from circulation e.g., during replacement of restorations. 
Social impacts 

Public  health  &  safety  and  health  systems:  Mercury  exposure  is  linked  with  health 
outcomes including cardiovascular mortality, IQ loss in younger age groups, and anemia. 
Based  on  EEA  damage  costs,  the  health  benefits  of  the  mercury  emissions  reductions 
outlined in  the previous section for 2030 are  estimated at  around  €6 million,  for PO4a, 
with  the  greatest  benefit  gained  through  emissions  reductions  among  crematoria 
operating  at  capacities  of  above  4,000  cremations  annually  (PO4b)  estimated  at  €2 
million and €3 million for PO4c (3,000 cremations annually and above). 

Abatement technology used to reduce mercury emissions also capture a number of other 
pollutants.  In  light  of  this,  human  health  benefits  would  also  be  experienced  through 
reductions  in  PM2.5  emissions  and  other  pollutants  (including  lead,  cadmium,  arsenic, 
chromium, nickel and dioxins and furans) estimated at €0.62 million (PO4a, 2030), €0.18 
million (PO4b, 2030) or €0.26 million (PO4c, 2030). 

Stakeholder views 

Overall, 86% (115/133) of respondents to the OPC believed that there should be an EU 
wide  policy  to  limit  mercury  emissions  from  crematoria.  This  picture  was  consistent 
across all stakeholder groups that responded to the OPC (i.e., civil society, EU & non-EU 
citizens,  companies  &  business  associations  and  public  authorities).  As  part  of  the 
targeted consultation, some stakeholders supported EU limits for all crematoria whereas 
other  stakeholders  expressed  concerns  about  impacts  on  smaller  crematoria  if  EU-wide 
limits were to be established and indicated that less stringent limits could be applied, or 
they could be excluded entirely. Some of the experts consulted indicated that crematoria 
should  be  treated  similarly  to  other  emission  points,  such  as  through  Best  Available 
Techniques  (BAT)  and  associated  emission  levels  (similar  to  the  Industrial  Emissions 
Directive)  whereas  others  felt  that  the  use  of  minimum  emission  limit  values  and  a 

53 

 
 
 
 
 
 
 
 
simpler  regulatory  approach  would  be  more  appropriate  (e.g.,  similar  to  the  Medium 
Combustion Plant Directive). 

6.3. 

6.3. Problem 3 – Mercury-added products for export to third countries 

6.3.1.  6.3.1. Analysis 

of 

Policy 
Option  5  –  Global  agreement 
to  ban  the  manufacture  and 
trade  of  mercury-containing 
lamps  

Economic impacts 

Conduct  of  business:  Under  a  global  ban  scenario,  EU  exports  of  FLs  would  stepwise 
decrease  to  zero  between  2026  and  2030.  The  accumulated  number  of  exported  FLs 
would be 167 million to 308 million units in comparison to 412 million to 693 million in 
the baseline scenario. The calculated accumulated loss of export value would be  €97 to 
€190  million  between  2025  and  2030.  Jobs  in  the  order  of  500  may  be  affected  by  an 
export ban. Demand for lighting products in general will not be affected by a global ban 
of mercury-containing lamps but instead is expected to increase (by about 4% annually). 
Thus,  manufacturers  have  opportunities  to  compensate  for  losses  in  the  conventional 
lighting  sector,  e.g.,  by  selling  LED  lamps/luminaries  and  smart  lighting  systems.  For 
other lamp types, the impact is considered small (about €25 million per year, or less than 
10%  of  annual  export  volume)  because  many  applications  still  fall  under  exemptions 
within the EU. The economic impact  for other MAPs  e.g.,  certain  types of rheometers, 
electrodes,  seam-welding  machines  could  not  be  quantified  but  is  considered  small  in 
comparison to lamps.  

Position of SMEs: In the case of FLs, SMEs would not be affected by an export ban since 
both  remaining  EU  manufacturers  belong  to  large  company  groups.  This  does  not 
necessarily  apply  to  SMEs  that  are  producing  other  lamp  types  (HID  lamps,  other  low 
pressure  discharge  lamps  for  special  purposes).  Manufacturers  of  aforementioned  other 
MAPs  are  typically  SMEs,  but  the  impacts  are  considered  minor  as  MAPs  are  only  a 
small part of their portfolio. 

Administrative  burden  on  businesses  and  public  authorities:  The  administrative  impact 
of a ban is considered small to negligible as the cessation of manufacture and exports is 
not related to specific administrative burdens.  

Environmental impacts 

A global ban on FLs for general lighting purposes would primarily result in less mercury 
being needed within the EU to produce discharge lamps. To the same extent, the mercury 
content  of  exported  lamps  would  decrease.  With  a  ban  taking  effect  in  two  steps  by  in 
2026 and 2028, this would affect a quantity of 0.9 to 1.5 t of mercury in the period 2026-
2030.  Stopping  the  export  could  prevent  some  0.8  to  1.3  t  from  entering  the  general 
waste  stream  and  contributing  to  a  contamination  of  soil  and  emissions  to  air  in  third 
countries, as currently only about 15% of lamps are recycled. 

54 

 
 
 
 
 
 
 
 
 
The magnitude of energy savings due to the switch from FLs to LEDs was estimated to 
be in  the order of 10 to  28 TWh. Considering a  carbon intensity of  electricity  of about 
475  g  CO2/  kWh,  this  would  result  in  a  lifetime  saving  of  about  5  to  13  Mt  CO2, 
constituting  an  important  contribution  to  the  fight  against  climate  change  and  to  the 
objectives under the EU decarbonisation agenda. 

Social impacts 

For citizens in importing third countries, the phase-out of mercury-containing fluorescent 
lamps would  eliminate the most important  source of product-related mercury exposure. 
New input of mercury into general waste would be avoided, so that populations working 
with  waste  (e.g.,  waste  pickers)  or  living  near  waste  dump  sites  have  a  lower  risk  of 
getting in contact with mercury. Social impacts in the EU are considered negligible. 

Stakeholder views 

During  the  stakeholder  consultation,  both  NGOs  and  business  associations  supported  a 
global  agreement  as  it  would  effectively  reduce  access  to  and  supply  of  MAPs,  reduce 
mercury demand and at the same time contribute to energy savings. At the same time, it 
provides  equal  conditions  for  all  market  participants.  However,  industry  stressed  the 
necessity of a gradual and manageable transition to LED-based lighting in order to avoid 
disruptions of the supply chain and to improve the availability of compatible LED plug-
and play solutions. 

6.3.2.  6.3.2. Analysis 

of 

Policy 
Option  6  –  EU  ban  on  the 
manufacture  and  export  of 
MAPs 

Economic impacts 

Conduct of business:  

  PO6a would ensure that all exports of would end from 2025, so that 412 million 
to 693 million FLs would no longer be exported. Their accumulated export value 
in the period 2025 to 2030 is €191 to €347 million. Jobs in the order of 500 may 
be affected by an export ban. If it is assumed that around 8% of the current HID 
lamp exports would be  affected by  an  export ban, about  6  million  units  of HID 
lamps  could  no  longer  be  exported  within  2025  to  2030.  Their  value  is  at 
approximately  €55  million.  For  dental  amalgam,  an  export  ban  would  affect 
predicted sales with a total retail value of about €50 to €300 million in the period 
2025-2030.  Because  of  the  costs  in  the  intermediate  trade,  the  manufacturers’ 
sales value is considerably smaller. The number of affected jobs is considered to 
be significantly below 200. 

  PO6b  would  ensure  that  all  exports  would  end  with  a  later  ban  on  1st  January 
2026  (halophosphate  LFLs)  and  1st  January  2028  (all  other  considered  lamp 
types),  so  that  167  million  to  308  million  FL  units  could  still  be  exported  until 

55 

 
 
 
 
 
 
 
 
 
 
then,  and  the  foregone  revenue  would  decrease  to  €97  to  €190  million,  the 
majority  of  which  (78%)  can  be  attributed  to  double-capped  FLs.  For  dental 
amalgam  sales  with  a  retail  value  of  €30  to  €200  million  in  the  period  2027  to 
2030 would be affected. The number of affected jobs is considered to be slightly 
below the values of option PO6a as exports and thus employment linked to these 
exports are expected to decrease even without a ban. 

The ability to compensate losses in FL sales by increased LED sales would depend on the 
extent these markets switch to LED solutions. Stakeholders agreed that a significant part 
of the FL market currently supplied by EU exports will shift to FLs manufactured in third 
countries (especially mainstream  lamp types). However, there are different  opinions on 
the extent of this shift and how long it will last. In this assessment, they are expressed by 
assuming that the substitution rate is 50-90% of EU exports (see Annex 07). 

The effect on employment for FL production would be similar to PO5 (global ban). The 
major difference between PO5 and PO6 (a and b) would be that FL exports from third 
countries  may  persist  under  PO6  until  a  global  ban  comes  into  force  and/or  the  full 
transition to LED.  

All  four  identified  manufacturers  that  have  not  yet  ceased  dental  amalgam  production 
belong to SMEs. Two of these companies specialize to a large extent in dental amalgam. 
Depending  on  the  relevance  of  the  amalgam  business,  an  export  ban  could  result  in  a 
reduction in sales if not replaced by the export of mercury-free filling materials or other 
dental products to third countries. 

Administrative  burden  on  businesses  and  public  authorities:  The  administrative  impact 
of a ban is considered small to negligible as the cessation of manufacture and exports is 
not related to specific administrative burdens.  

Environmental impacts 

An EU export ban from 2025 would avoid the use of about 1.21 t to 2.17 t of mercury in 
European  lamp  products  between  2025  and  2030.  About  85%  of  this  amount  or  1  t  to 
1.9 t would not enter the general waste stream in importing countries. With an export ban 
from 2026/2028, the mercury content in exports would decrease by 0.8 t to 1.5 t and the 
mercury  input  into  general  waste  by  0.7  t  to  1.3  t.  However,  this  is  countered  by  the 
amount of mercury  contained in  FLs that are imported instead of European lamps. The 
assessment  considers  a  level  of  substituting  imports  in  the  range  of  50%  to  90%.  In 
addition, non-European FLs have a significantly higher average mercury content. While 
the difference for CFL.ni lamps is often only small and amounts to only a few tenths of a 
milligram,  the  difference  is  higher  for  the  economically  more  important  FL  lamps  and 
there especially for halophosphate lamps (3 to 5 mg per lamp). 

For the scenario of an export ban from  2025, the substitute FLs  would have a mercury 
content that is 0.53 t lower but can also be 1.59 t higher. The low values of this range are 
only  realised  when  low  substitution  rates  and  low  mercury  contents  in  substituting 
imports  coincide.  The  range  is  smaller  if  an  export  ban  is  considered  from  2026/2028 
(-0.32 t to 1.12 t). For HID lamps the environmental impact is expected to be limited. 

56 

 
 
 
 
 
 
 
 
 
An EU decision by the EU is not detached from further negotiations at the international 
level. If an EU export ban and a global ban coincide in 2026/2028, the effect is equally 
positive as if there had only been a global ban (-1.50 t to -0.97 t). Should the global ban 
occur  two  years  later  (2028/2030),  the  net  effect  is  still  positive  (-0.57  t  to  -0.24  t),  as 
substitute imports could only occur for a maximum period of two years. 

In  the  case  of  an  export  ban  in  2025,  the  mercury  content  of  exported  dental  amalgam 
would decrease by approximately 30 t to 180 t in the years 2025 to 2030. A later phase-
out  (2027)  would  result  in  a  decrease  of  20  t  –  120  t.  The  reduced  exports,  if  not 
substituted by dental amalgam supply from other third countries would result in reduced 
mercury releases to air and soil in the same order of magnitude. 

Social impacts 

An  EU  ban  on  the  manufacture  and  export  of  MAPs  will  contribute  to  a  decrease  of 
mercury  input  into  the  society,  thus  reducing  the  risk  of  exposure  and  contamination. 
However, should third country markets replace EU made MAPs by imported MAPs from 
other countries, this could lead to continued mercury pollution. However, such negative 
impacts are limited to a couple of years until the predicted general decrease of FL sales 
compensates a possible short-term effects or measures. 

In case of an EU ban on dental amalgam export, access of practitioners in third countries 
could become more difficult in the short-term. However, in the context of the Minamata 
Convention, the African Region has already highlighted its capacity to “leap-frog” dental 
amalgam  and  provide  patients  with  mercury-free  alternatives.  Consequently,  an  EU 
export  ban  of  dental  amalgam  may  incentivize  the  accelerated  transition  from  dental 
amalgam  to  mercury-free  alternatives  in  third  countries  in  the  long-term,  depending  on 
their health systems and self-defined priorities. 

Stakeholder views 

NGO’s  supported  unilateral  measures  and  expected  an  overall  positive  environmental 
impact  caused  by  reduced  supply  from  the  EU  in  combination  with  national  measures 
that  follow  the  EU  example.  They  preferred  an  early  phase-out  of  exports  as  it  would 
avoid  a  higher  amount  of  mercury  used  in  lamps.  On  the  other  hand,  businesses 
expressed  concerns  that  cutting  supply  to  the  global  market  from  the  EU  could  be 
compensated  to  a  large  extend  by  increased  imports  from  third  countries.  In  case  of 
lamps, they expect a neutral or even negative effect because persistent demand could be 
met  by  imports  of  lamps  (e.g.,  from  Asia)  with  a  higher  mercury  content.  Businesses 
expressed caution over unilateral measures and preferred a global agreement on MAPs. 
In  addition,  businesses  stressed  the  need  for  sufficient  transition  periods  as  short-term 
phase-outs  pose  serious  challenges  for  users  who  may  need  to  make  significant 
investments  to  replace  existing  luminaires.  Also,  time  is  needed  to  re-export  legally 
imported  lamps  that  are  currently  in  European  distribution  centers.  Concerning  dental 
amalgam, only one amalgam manufacturer submitted an opinion, stressing that European 
exports mainly go to low-income countries where many clinics don’t have the technical 
equipment for mercury-free fillings.  

57 

 
 
 
 
 
 
 
 
 
7.  7.  HOW DO THE OPTIONS COMPARE? 

The legal basis for this initiative is Article 19 of the Mercury Regulation, which requires 
the Commission to address three distinct issues, different in nature addressing the largest 
remaining intentional use of mercury in the EU (problem area 1), mercury emissions to 
air (problem area 2) and the alignment of EU law on MAPs (problem area 3).  

Regardless  of  differences  in  scope  and  objectives,  this  initiative  seeks  to  provide  for  a 
single  policy  package  with  an  overall  objective  towards  a  non-toxic  environment.  In 
doing  so,  for  the  purpose  of  developing  an  effective,  efficient  and  proportionate  policy 
package, this initiative makes comparisons across problem areas, where feasible.  

This section highlights the key aspects of the impact assessment relevant for supporting 
decision-making  on  the  choice  of  options  and  sub-options  to  include  in  the  preferred 
package.  It  identifies  which  sub-options  have  a  favourable  cost-benefit  profile. 
Furthermore, where sub-options include alternatives, their impacts are compared (Table 
13, Table 14 and Table 15).  

Problem area 1 - Dental amalgam: Comparison between PO1 and PO2  

Regarding PO1, as a ‘soft’ policy option, the assessment of the economic, environmental 
and  social  impacts  of  the  implementation  of  communication  campaigns  shows  that  it 
would not  deliver strong positive outcomes across the EU. Whilst  the foreseen impacts 
are likely to be minimal in terms of costs, they would yield only limited environmental 
and social benefits. Due to uncertainties regarding the type, extent, content and potential 
overlaps with existing national campaigns, it not possible to robustly quantity the impacts 
of PO1.           

Concerning  PO2,  as  a  ‘hard’  policy  option,  the  assessment  of  the  economic, 
environmental  and  social  impacts  of  the  implementation  of  a  legally  binding  phase-out 
on  the  use  of  dental  amalgam  shows  that  significant  environmental  and  human  health 
benefits are associated with that option compared to PO1. Yet, due to the very nature of 
PO2  as  a  legally  binding  measure  and  its  associated  implementation  (compulsory 
substitution  of  dental  amalgam  with  mercury-free  alternatives),  that  option  incurs  more 
costs compared to PO1.   

The extent to which PO2 yields environmental and human health benefits depends on the 
date  when  the  obligation  to  phase-out  the  use  of  dental  amalgam  enters  into  force.  In 
particular,  the  cumulative  reductions  of  mercury  emissions  by  2030  are  significantly 
higher with an early phase-out date: 51.7 t for PO2a (2025), 21.9 t for PO2b (2027) and 
6.0  t  for  PO2c  (2030)  (see  Table  9).  In  parallel,  human  health  benefits  as  a  result  of 
reduced mercury emissions to air from crematoria will also be significantly higher with 
an earlier phase-out date (2025), valued at €900,000 in 2030 compared to €50,000 with a 
2030 phase-out date.  

58 

 
 
 
 
 
 
 
 
 
 
 
Problem area 2 – Emissions from crematoria: Comparison between PO3 and PO4 

As  PO2  addresses  the  reduction  of  mercury  use  at  source  resulting  de  facto  in 
significantly reduced mercury  emissions from  crematoria, it decreases the  effectiveness 
and cost-benefit ratio of PO3 and PO4. Hence, with PO2 in place, operators of crematoria 
will only have to abate mercury emissions from legacy dental amalgam.  

Regarding PO3, as a ‘soft’ policy option, the assessment of the economic, environmental 
and social impacts  of the development  of  a non-legally binding  guidance on abatement 
technologies  to  control  and  reduce  mercury  emissions  from  crematoria  shows  some 
environmental and human health benefits. Estimated mercury emissions reductions of 17 
kg  in  2030  have  been  estimated  assuming  no  phase-out  of  dental  amalgam,  delivering 
human health benefits valued at just over €300,000. Costs to operators in 2030 assuming 
no  phase-out  of  dental  amalgam  are  estimated  as  total  one-off  capital  costs  of  €10.3 
million and annual operating costs of €0.32 million.  

Concerning  PO4a,  PO4b  or  PO4c,  as  a  ‘hard’  policy  option,  the  assessment  of  the 
economic, environmental and social impacts of an EU-wide obligation to install mercury 
emission abatement  technologies  in  crematoria  shows higher environmental and human 
health benefits compared to PO3, but significantly higher associated costs.  

Under  PO4a,  estimated  mercury  emissions  reductions  amount  to  314  kg  in  2030, 
delivering human health benefits valued at €6.1 million. However, when combined with 
PO2a,  estimated  emissions  reductions  amount  to  269  kg  in  2030,  delivering  human 
health  benefits  valued  at  €5.3 million.  PO4a is  expected  to  deliver  a  100%  uptake  of 
emissions  abatement  across  all  crematoria  in  the  EU  and  is  estimated  to  result  in  total 
one-off capital costs of €182 million, and annual operating costs of €6 million.  

Under  PO4b,  estimated  mercury  emissions  reductions  amount  to  141  kg  in  2030, 
delivering human health benefits valued at €2.7 million. However, when combined with 
PO2a, emissions reductions amount to 113 kg in 2030, delivering human health benefits 
valued  at  €2.2 million.  PO4b is  expected  to  deliver  a  100%  uptake  of  emissions 
abatement across crematoria operating at a capacity of ≥ 4000 cremations per year and is 
estimated  to  result  in  total  capital  costs  of  €15  million  and  annual  operating  costs  of 
€0.46 million.  

Under  PO4c,  estimated  mercury  emissions  reductions  amount  to  191  kg  in  2030, 
delivering human health benefits valued at €3.4 million. However, when combined with 
PO2a, emissions reductions amount to 156 kg in 2030, delivering human health benefits 
valued at €2.7 million. PO4c is expected to deliver 100% uptake of emissions abatement 
across  all  crematoria  operating  at  a  capacity  of  ≥  3000  cremations  per  year  and  is 
estimated  to  result  in  total  capital  costs  of  €25  million  and  annual  operating  costs  of 
€0.78 million. 

Problem area 3 – Mercury-added products: Comparison between PO5 and PO6 

Regarding PO5, as an option based on potential developments at international level, the 
assessment  of  the  economic,  environmental  and  social  impact  shows  that  the  estimated 

59 

 
 
 
 
 
 
 
 
 
 
decreased  demand  for  mercury  in  the  EU  to  be  used  for  producing  the  concerned 
mercury-containing  lamps  (relevant  LFLs)  amount  to  0.8-1.5  t  (2026-2030)  and  the 
cumulative  foregone  revenues  to  EU  businesses  amount  to  €144  million  (€97-190 
million) (2026-2030). PO5 is characterised by a high level of uncertainty as Parties to the 
Minamata Convention may fail to reach an agreement at COP5 or at subsequent COPs on 
the phase-out dates for relevant MAPs80.   

Concerning  PO6,  as  an  option  based  on  a  unilateral  prohibition,  the  assessment  of  the 
economic,  environmental  and  social  impact  shows  that  the  decreased  demand  for 
mercury in the EU to be used for producing the concerned mercury-containing lamps 
(relevant  LFLs, CFLs and HPS) amounts to 1.2-2.2 t (export ban in 2025 under PO6a) 
and to 0.8-1.5 t (export ban in 2026/2028 under PO6b). Both PO6a and PO6b would lead 
to  cumulative  foregone  revenues  to  EU  businesses  amounting  to  €191-347  million 
(PO6a; 2025-2030) or to € 144 million (PO6b; 2026-2030).  

The  assessment  of  the  economic,  environmental  and  social  impact  shows  that  PO6a 
applied only to dental amalgam would reduce the EU export of mercury in the range of 
13-38 t and affect predicted sales with a total retail value of about €50 to €300 million in 
the period 2025-2030.  

It is to be noted that both PO5 and PO6b are assumed to result in similar environmental 
benefits  and  foregone  revenues,  should  the  international  community  agree,  based  on 
Minamata Decision MC-4/6, on the most ambitious proposed phase-out date (2026) to be 
considered  by  Parties  to  the  Minamata  Convention  at  COP5.  However,  considering  the 
uncertainty linked to PO5, PO6b provides for certainty across the EU on the applicable 
regulatory regime to MAPs.  

Colour coding is used to summarise the assessment of impacts referring to the direction 
(positive or negative) and magnitude (small or large) of any expected impacts (see Table 
13). 

Table 13: Coding used to present expected impacts 

XXX 
Extremely 
negative 

XX 
Strongly 
negative 

X 
Weakly 
negative 

O 
Zero  i.e.,  no 
limited 
or 
impact 

✓ 
Weakly 
positive 

✓✓ 
Strongly 
positive 

✓✓✓ 
Extremely 
positive 

The coding provided in the summary tables below for each policy option are based on the 
detailed assessment of impacts (see Annex 8) for each measure and option. Quantitative 
information on the likely impacts of each option was not always available and, where it 
was,  it  was  not  always  comparable  across  options  e.g.,  compliance  costs  compared  to 
potential  loss  of  revenue.  Therefore,  expert  judgement  has  been  applied  for  the  overall 
coding and comparison.  

80   For reminder, the phase-out of dental amalgam for all members of the population at global level is not 
currently  envisaged  by  Parties  to  the  Minamata  Convention,  hence  PO5  does  not  address  the 
manufacture and export of dental amalgam.   

60 

 
 
 
 
 
 
 
 
 
                                                           
61 

 
 
 
 
Table 14: Summary of impacts for PO1 to PO4 (Problems 1 and 2) 

Policy option 

Main impacts 

Benefits 

Costs 

Admin burden 

Key aspects 

Econ. 
O / X 

Env. 
O / ✓ 

Social. 
O / ✓ 

PO1 
Communication 
campaign 

 Benefits  not  feasible  to  quantify  due 
to  high  uncertainties  and  overlaps 
with 
health 
campaigns. 

existing 

dental 

 Increased  employment  in  organizing 
awareness-raising  activities,  training 
dentists  in  mercury-free  restoration, 
mercury-free 
of 
and 
alternatives. 

R&D 

 Potential 

resulting 

in 
mercury  emissions  to  air,  soil,  and 
water. 

reductions 

Establish 
PO2 
legally 
binding 
end  date  for  use 
dental amalgam 

X 

✓✓✓ 

✓ 

Cumulative reductions in mercury used 
in dental restorations of: 

 PO2a  (2025  phase-out):  114.4  t  by 

2035  

 PO2b  (2027  phase-out):  75.9  t  by 

2035  

 PO2c  (2030  phase-out):  29.8  t  by 

2035 

Estimated  cumulative  reductions 
in 
direct  mercury  emissions  from  dental 
amalgam phase-out by 2030 of: 

  Limited 

costs 
for 
and 

anticipated 
developing 
running 
communication 
campaigns 
(existing 
campaigns  already  in 
place  for 
improving 
dental hygiene). 
loss 

of 
business  to  amalgam 
producers  depending 
factors 
on 
and 
(e.g., 
extent 
the 
campaign). 

content 
of 

several 

  Potential 

 Loss  of  business 

to 
of 
fillings, 
using 
products 
be 
to 

manufacturers 
amalgam 
dentists 
amalgam 
estimated 
limited. 

 Anticipated  that  they 
would quickly adapt in 
case  of  a  phase-out  in 
on-going 
light 
of 
decreasing 
in 
trend 
dental amalgam use. 

 PO2a: 3.1 t to air, 3.4 t to soil, 0.6 t 

Estimated 

increased 

Limited 

Many  MSs  already  implement 
such  communication  campaigns 
so  limited  additional  impacts 
anticipated 
further 
awareness raising campaigns.  

from 

  Business 0 
  Public 

authorities <1 

Scale  and  timing  of  impacts 
depend  on  sub-options  PO2a, 
PO2b and PO2c.  

to 

Unlike  for  the  reductions  of 
emissions 
mercury 
from 
it  has  not  been 
crematoria, 
possible 
value/monetize 
robustly  the  benefits  associated 
with PO2. Therefore, the valued 
benefits 
significantly 
underestimated,  and  it  is  not 
feasible or appropriate to present 
a  cost-benefit  ratio  as  for  PO3 
and PO4. 

are 

 
 
 
 
 
 
 
 
 
 
 
 
Policy option 

Main impacts 

Benefits 

Costs 

Admin burden 

Key aspects 

. 

short-term costs of dental 
treatment  (for  citizens, 
social  security  and./or 
private 
healthcare 
depending  on  systems  in 
place  in  each  MS)  as  a 
result of use of  mercury-
free alternatives:  

  PO2a: €208 million   
  PO2b: €170 million  
  PO2c: €114 million  

Econ. 

Env. 

Social. 

to  waterbodies, 
wastewater. 

and 

2.6 t 

to 

 PO2b: 1.3 t to air, 1.4 t to soil, 0.3 t 
to 

1.1 t 

and 

to  waterbodies, 
wastewater 

 PO2c: 0.4 t to air, 0.4 t to soil, 0.1 t 
to 

to  waterbodies,  and  0.3 
wastewater.  

t 

Estimated 
in  mercury 
emissions from crematoria by 2030 of: 

reductions 

  PO2a: 54 kg  
  PO2b: 31 kg 
  PO2c: 3 kg.  

Human health benefits from reductions 
in  mercury  emissions  from  crematoria 
valued at: 

  PO2a: €900,000   
  PO2b: €500,000  
  PO2c: €50,000  

Anticipated  social  benefits  resulting 
from PO2 combine: 

i.  improved 

health 

reduced  mercury 
exposure,  

thanks 

to 
pollution 

ii.  positive 

impacts  of 

improved 

63 

 
 
 
 
 
 
 
 
 
 
 
 
Policy option 

Main impacts 

Benefits 

Costs 

Admin burden 

Key aspects 

Econ. 

Env. 

Social. 

iii.  R&I 

dental  aesthetics,  especially  for 
modest income households,  
promotion 
to  slight 

potentially 
in 
leading 
employment,  but  also 
slight 
increases of expenses for national 
healthcare systems 

increases 

PO3 
guidance 
emissions 
abatement 
crematoria 

X 

Issue 
on 

in 

✓ 

✓ 

  Total 

and 
capital 
operational  costs  of 
€1.1  million  (EAC) 
in  2030 
(with  or 
without PO2). 

  Business 0 
  Public 

authorities  – 
limited  costs 
EU 
for 
institutions 
to 
guidance 

prepare 

Non-legally  binding  guidance 
will  be  helpful  for  those  MSs 
that  do  not  currently  address 
mercury 
from 
crematoria.  

emissions 

  PO3: estimated mercury emissions 
reductions  of  17  kg 
in  2030, 
delivering  human  health  benefits 
valued  at  €300,000.  Associated 
(when 
cost-benefit  ratio:  0.31 
benefits 
from  other  pollutant 
reductions,  described  below,  are 
also accounted for). 

  PO3 

combined  with  PO2a: 
estimated  emissions  reductions  of 
14  kg  in  2030,  delivering  human 
health benefits valued at €280,000. 
Associated cost-benefit ratio: 0.27 
(when benefits from other pollutant 
reductions,  described  below,  are 
also accounted for). 

  PO3: 

estimated 

reductions 

in 
emissions  of  PM2.5  and  other 
pollutants  delivering  human  health 
benefits valued at €36,000. 

PO4a  Mandatory 
application of best 

XXX 

✓✓ 

✓✓ 

  PO4a: 

mercury 
estimated 
emissions  reductions  of  314  kg  in 

  Total 

and 
capital 
operational  costs  of 

  Business 
€400,000 

The  mandatory  application  of 
BAT  for  crematoria  in  the  EU 

64 

 
 
 
 
 
 
 
Policy option 

Main impacts 

Benefits 

Costs 

Admin burden 

Key aspects 

Econ. 

Env. 

Social. 

available 
abatement 
techniques  for  all 
crematoria 

2030,  delivering  human  health 
benefits  valued  at  €5.5 million. 
Associated cost-benefit ratio: 0.31 
(when benefits from other pollutant 
reductions,  described  below,  are 
also accounted for). 

€19.2  million  (EAC) 
in 2030. 

  Public 

authorities 
€500,000 

  PO4a  combined  with  PO2a: 
estimated  emissions  reductions  of 
269  kg  in  2030,  delivering  human 
health 
at 
benefits 
cost-
€4.7 million.  Associated 
benefit  ratio:  0.27  (when  benefits 
from  other  pollutant  reductions, 
described 
also 
below, 
accounted for). 

valued 

are 

  PO4a:  estimated 

reductions 

in 
emissions  of  PM2.5  and  other 
pollutants  delivering  human  health 
benefits valued at €621,000. 

X 

✓ 

✓ 

PO4b  Mandatory 
application of best 
available 
abatement 
techniques 
for 
above 
cremations 
year 

only 
crematoria 
4000 
per 

  PO4b: 

mercury 
estimated 
emissions  reductions  of  141  kg  in 
2030,  delivering  human  health 
benefits  valued  at  €2.5 million. 
Associated cost-benefit ratio: 1.65 
(when benefits from other pollutant 
reductions,  described  below,  are 
also accounted for). 

  PO4b  combined  with  PO2a: 
estimated  emissions  reductions  of 

65 

  Total 

and 
capital 
operational  costs  of 
€1.6  million  (EAC) 
in 2030. 

  Business 
€23,000 

  Public 

authorities 
€28,000 

implementation 

the  development 
will  require 
of 
and 
requirements, 
associated 
including 
of 
permit/registration,  monitoring, 
reporting, inspections etc.   

terms 

in 

The  mandatory  application  of 
BAT  for  crematoria  in  the  EU 
the  development 
will  require 
of 
and 
requirements, 
associated 
including 
of 
permit/registration,  monitoring, 
reporting, inspections etc.   

implementation 

terms 

in 

 
 
 
 
 
 
 
 
 
Policy option 

Main impacts 

Benefits 

Costs 

Admin burden 

Key aspects 

Econ. 

Env. 

Social. 

valued 

113  kg  in  2030,  delivering  human 
at 
health 
benefits 
cost-
€2.0 million.  Associated 
benefit  ratio:  1.34  (when  benefits 
from  other  pollutant  reductions, 
described 
also 
below, 
accounted for). 

are 

  PO4b:  estimated 

reductions 

in 
emissions  of  PM2.5  and  other 
pollutants  delivering  human  health 
benefits valued at €183,000. 

X 

✓ 

✓ 

PO4c  Mandatory 
application of best 
available 
abatement 
techniques 
for 
above 
cremations 
year 

only 
crematoria 
3000 
per 

  Total 

and 
capital 
operations  costs  of 
€2.6  million  (EAC) 
in 2030. 

  Business 
€42,000 

  Public 

authorities 
€53,000 

  PO4c: 

mercury 
estimated 
emissions  reductions  of  191  kg  in 
2030,  delivering  human  health 
benefits  valued  at  €3.4  million. 
Associated  cost-benefit  ratio:  1.33 
(when benefits from other pollutant 
reductions,  described  below,  are 
also accounted for). 

  PO4c  combined  with  PO2a: 
estimated  emissions  reductions  of 
155  kg  in  2030,  delivering  human 
health  benefits  valued  at  €3 
million.  Associated  cost-benefit 
ratio:  1.10  (when  benefits  from 
reductions, 
other 
also 
are 
described 
accounted for). 

pollutant 
below, 

  PO4c:  estimated 

reductions 

in 

66 

The  mandatory  application  of 
BAT  for  crematoria  in  the  EU 
the  development 
will  require 
of 
and 
requirements, 
associated 
including 
of 
permit/registration,  monitoring, 
reporting, inspections etc.   

implementation 

terms 

in 

 
 
 
 
 
 
Policy option 

Main impacts 

Benefits 

Costs 

Admin burden 

Key aspects 

Econ. 

Env. 

Social. 

emissions  of  PM2.5  and  other 
pollutants  delivering  human  health 
benefits valued at €260,000. 

67 

 
 
Table 15: Summary of impacts for PO5 and PO6 (Problem 3) 

Policy option 

PO5  Seek  change  to 
international 
agreement 

Main impacts 
Econ. 
X 

Env. 
✓✓✓ 

Social. 
✓✓ 

PO6 EU export ban 

XX 

✓✓ 

X / ✓ 

Benefits 

Compliance costs 

  Foregone 

revenues  to  EU 
of 
businesses 
€144 
million 
(€97-190 
million) 
2030) 
mercury-
containing 
lamps. 

(2026-
for 

  Foregone 

revenues  to  EU 
of 
businesses 
€50-300  million 
for 
dental 
amalgam  (2025-
2030) 
Foregone 
revenues 
to EU businesses of: 

  PO6a:  €191-347 
(2025-

million 
2030) 

  PO6b: 
million 
2030) 

€97-190 
(2026-

  Decreased  demand 
for 

for  mercury 
mercury-
containing 
lamps 
production  in  the 
order  of  0.8-1.5  t 
(2026-2030) 

  Decreased  demand 
for 
for  mercury 
dental 
amalgam 
production  in  the 
order  of  30-180  t 
(2025-2030). 

demand 
for 

Decreased 
for  mercury 
mercury-containing 
lamps production of: 

  PO6a: 1.2-2.2 t  
  PO6b: 0.8-1.5 t  

of 
release 
Lower 
mercury 
to  general 
waste  and  resulting 
reduced 
human 
exposure.  

costs 

Admin 
€million/y 
  Business 0 
  Public  authorities 

0 

Key aspects 

On  the  one  hand,  the  analysis  has 
quantified  the  potential  reduction  in 
demand for mercury for production of 
MAPs.  Yet,  on  the  other  hand  and 
unlike  for  PO3  and  PO4,  it  has  not 
been  feasible  to  further  quantify  or 
value  the  benefits  (e.g.  impacts  for 
the  environment  and  human  health) 
due  to  the  significant  uncertainties 
the  fate  of  such 
associated  with 
MAPs in third countries.  

  Business 0 
  Public  authorities 

0 

Overall,  a  positive  environmental 
impact  is  expected  but  this  strongly 
depends  on  willingness  of  Parties  to 
the Minamata Convention to agree on 
a  global  ban  at  COP5  or  at 
subsequent COPs.  
As  set  out  above  for  PO5,  whilst  the 
analysis  has  quantified  the  potential 
reduction  in  demand  for  mercury  for 
production  of  MAPs,  it  has  not  been 
feasible  to  further  quantify  or  value 
the  benefits  (e.g.,  impacts  for  the 
environment  and  human  health)  due 
uncertainties 
to 
the  fate  of  such 
associated  with 
MAPs in third countries.  

significant 

the 

The  ultimate  benefits  will  depend 
upon  the  resources  and  regulatory 
measures  for  such  MAPs  in  third 

 
 
 
 
 
 
 
 
 
 
 
 
countries. As a result, it has not been 
feasible to present a cost benefit ratio 
similar to PO3 and PO4.  

Overall  impacts  will  depend  on  rate 
of  FL  substitution  in  importing  third 
countries  and  mercury  content  of 
lamps produced outside the EU. 

time 

Economic operators may better adapt 
the  longer  the  transition  phase,  i.e.  if 
more 
the 
adoption  of 
the  manufacture  and 
export ban decision and its entry into 
force. 

is  given  between 

69 

 
 
 
 
8.  8.  PREFERRED OPTION 

Table 16 summarises the broad rationale for selecting or discarding (sub-)options. Retained 
(sub-) options appear in bold. The preferred Policy Option for problem area 2 will require a 
political choice. 

Table 16: (Sub-) options included in and discarded from the preferred policy package 

POLICY OPTION 

BROAD RATIONALE FOR RETAINING OR DISCARDING THE OPTION/SUB-OPTION 

1 – Reducing the health and environmental risks associated with mercury exposure during the use and 
disposal of mercury containing dental amalgam. 

Several such campaigns are already organised by MSs and the consultation responses 
show that most people are aware of impacts of mercury and availability of alternatives. 
Whereas some sectoral  stakeholders consider the  above-mentioned initiatives of high 
relevance, in terms of pollution control, they are not expected to have much impact. 

A number of MSs have already phased out dental amalgam use or are planning to in 
the  coming  years  demonstrating  that  it  is  technically  feasible  to  do  so.  Although  the 
baseline shows significant reductions in usage for all MSs over the assessment period, 
an EU wide phase-out of the use of dental amalgam would ensure a uniform phase-out 
across  all  MSs  and  place  the  EU  in  a  first-move  leadership  role  in  relation  to  future 
international negotiations within the context of the Minamata Convention. 2025 is the 
preferred option for phase-out as it would lead to the greatest environmental and health 
benefits and is considered feasible to implement within this time frame.  

to 

PO1:  Communication 
campaign 
raise 
awareness  and  change 
behaviour  of  dental 
patients (discarded) 

PO2: Establish legally 
binding  end  date  for 
the  use  of  mercury-
containing 
dental 
amalgam in the EU. 
Sub-option  phase-out 
by 2025 (retained) 

Sub-options  phase-out 
by  2027  or  2030 
(discarded) 

2 – Reducing the health and environmental risks associated with mercury emissions from crematoria. 

PO3:  EU  guidance  on 
BAT for crematoria 

Non-legally  binding  EU  guidance  on  abatement  technology  for  mercury  emissions 
from crematoria should provide a valuable reference  guide for the MSs to be able to 
implement  controls  at  national  (or  local  or  regional)  level.  This  should  be  of  most 
value to those MSs that do not currently regulate  mercury emissions from crematoria 
and choose to do so voluntarily e.g., for a crematorium located near residential areas or 
for pollution control of other substances. Documents on BAT have been developed by 
the  European  Commission  for  other  sectors  under,  in  particular,  the  Industrial 
Emissions  Directive81  and  the  Mining  Waste  Directive82.  A  supporting  voluntary 
agreement with the sector has been discarded as it is not considered feasible to broker 
such an agreement at EU level and should be left to the MSs to determine how best to 
engage with the sector.  

81  Directive 2010/75/EU  of 

the  European  Parliament  and  of 

the  Council  of  24 November  2010 

on industrial emissions (OJ L 334, 17.12.2010, p. 17–119). 

82 Directive 2006/21/EC of the European Parliament and of the Council of 15 March 2006 on the management 
of waste from extractive industries and amending Directive 2004/35/EC (OJ L 102, 11.4.2006, p. 15–34). 

70 

 
 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
PO4: Mandatory 
application of best 
available abatement 
techniques to reduce 
mercury emissions 
from crematoria.  

Sub-option: for all 
crematoria  
Sub-option: only for 
crematoria with 
capacity  ≥ 4000 
Sub-option: only for 
crematoria with 
capacity ≥ 3000 

Whilst  mandatory  application  of  abatement  technology  would  guarantee  a  uniform 
application of abatement across the EU, the potential costs relative to benefits are high, 
particularly for the smaller, more numerous crematoria, many of which are SMEs.  In 
addition,  if  dental  amalgam  is  phased  out  in  2025  (PO2a)  then  emissions  from 
crematoria will be even lower by 2030 so the cost effectiveness of this option reduces. 
When the  obligation to  operate crematoria  with  abatement techniques  applies  only  to 
larger  crematoria  (more  than  4000  cremations/year),  the  cost-benefit  ratio  becomes 
slightly  positive.  This  would  capture  around  30%  of  mercury  emissions  from  all  EU 
crematoria of all sizes while keeping the administrative costs for the authorities and the 
economic  costs  for  the  operators  reasonable.  However,  only  a  few  Member  States 
would  be  concerned  (in  particular  DE,  HU),  i.e.,  this  raises  questions  about  the  EU 
added  value.  When  the  obligation  to  operate  crematoria  with  abatement  techniques 
applies to crematoria with a capacity ≥ 3000 cremations per year, the cost-benefit ratio 
is reduced. 

3 – Reducing the health and environmental risks associated with mercury contained in products intended 
for export from the EU (but banned in the EU). 

PO5: Seek change to 
international 
agreement to prevent 
(manufacture and) 
export of mercury 
containing products 
which would then be 
transposed into EU 
law (retained) 

PO6: Introduce an 
EU ban on the export 
of mercury containing 
products already 
prevented from being 
placed on the market 
in the EU 

Sub-option  by  2025 
(retained  for  dental 
amalgam)  
Sub-option by 
2026/28 (retained for 
relevant mercury-
containing lamps 

This  option  is  considered  an  effective  approach  to  achieve  a  maximum  reduction  of 
product-related mercury use and emissions. If agreed upon by Parties to the Minamata 
Convention, it provides for an international phase-out of MAPs. The instrument would 
close  most,  if  not  all,  loopholes  for  third  country  manufacturers  (other  than  an  EU 
ban).  Due  to  its  consensual  character,  interests  and  priorities  of  third  countries, 
especially  developing  countries  are  explicitly  considered.  However,  the  outcome  of 
international  negotiations  on  the  prohibition  of  additional  MAPs  is  undoubtedly 
uncertain regarding both its content and timing. 

An  EU  ban  would  allow  the  EU  to  take  immediate  action  and  to  further  decrease 
export  of  MAPs  independently  form  the  outcome  of  future  negotiations  at  the 
international  level  (Minamata  Convention).  Thereby,  the  EU  could  lower  its  external 
pollution footprint. Such an action is a political signal to other countries that may wish 
to  follow  this  path  and  prohibit  the  sale/export  of  MAPs  as  well.  However,  the  EU 
cannot restrict the import to third countries of MAPs produced outside the EU. Part of 
EU-made  products  may  be  substituted  by  products  with  a  possibly  higher  mercury 
level.  The  risk  for  net  negative  impacts  decreases  if  more  time  is  planned  between 
adoption  of  the  initiative  and  entry  into  force  of  a  manufacture  and  export  ban.  This 
would also give third countries more time to adjust their national legislation. If closely 
followed  by  a  global  ban  (PO5)  no  negative  impacts  are  to  be  expected.  This  is  the 
reason  why  a  ban  on  the  manufacture  and  export  of  FLs  in  2026/2028  is  preferred 
whereas  a  similar  prohibition  on  the  manufacture  and  export  of  dental  amalgam  in 
2025 is preferred.  

Overall,  the  preferred  policy  package  would  likely  generate  significant  and  positive 
environmental impacts and incur limited negative economic impacts. Where it has not been 
possible to systematically quantify and monetise all impacts for all measures, quantification 
has been supplemented with qualitative data based on expert judgement. 

71 

 
 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.1.1  PREFERRED POLICY OPTION FOR PROBLEM 1 

The  preferred  policy  option  for  Problem  Area  1  tackles  the  issue  of  continued  dental 
amalgam use at source through the earliest possible phase-out (2025) (PO2a). An EU wide 
phase-out of the use of dental amalgam would ensure a uniform phase-out across all Member 
States  and  place  the  EU  in  a  first-mover  leadership  role  in  relation  to  future  international 
negotiations within the Minamata Convention. Absence of such action could result in global 
criticism and risks reduced credibility of the EGD and EU Chemicals policy at global level. 

Whilst  this  will  lead  to  some  additional  costs  due  to  the  current  cost  difference  between 
dental  amalgam  and  mercury-free  alternatives,  many  Member  States  are  already  planning 
phase-outs  so additional  impacts  of EU  action are relatively  limited. These additional  costs 
decline  over  time  as  the  cost  difference  between  dental  amalgam  and  mercury-free 
alternatives is expected to narrow with greater demand and innovation. The year 2025 is the 
preferred  option  for  a  phase-out  as  it  would  lead  to  the  greatest  environmental  and  health 
benefits  and is  considered feasible to  implement  within a short timeframe (as demonstrated 
by some Member States already having phased out, or planning to phase out, dental amalgam 
use by then). 

The  phase-out  of  dental  amalgam  use  in  the  EU  will  lead  to  significant  benefits  for  the 
environment  and  health.  In  addition,  it  will  lead  to  reductions  in  mercury  emissions  from 
crematoria, which will continue to steadily decline over time.  

8.1.2  PREFERRED POLICY OPTION FOR PROBLEM  2  

The  policy  options  concerning  mercury  emissions  from  crematoria  will  require  a  political 
choice. The outcome of this choice will have environmental and economic impacts. There are 
advantages and disadvantages associated with each policy option identified for Problem 2.   

Regarding PO4a or PO4b, on the one hand, it would ensure the implementation of a uniform 
and  legally  certain  obligation  to  install  mercury  emission  abatement  technologies  in 
crematoria across the EU at a time where cremation rates are increasing. On the other hand, 
whereas for PO4a, in practice, all EU crematoria (25 Member States) would be covered under 
PO4a,  this  proves  not  to  be  cost-beneficial  with  a  very  low  cost-benefit  ratio  of  0.31. 
Furthermore, PO4a would prove to place considerable economic pressure on SMEs operating 
crematoria  with  low  capacity  (noting  that  the  sector  is  dominated  by  SMEs)  as  well  as 
significant  administrative  burden  on  operators  and  competent  authorities  (e.g.,  compliance 
and  enforcement).  Whilst  a  slightly  positive  cost-benefit  ratio  (between  1.34  or  1.65, 
depending on the implementation of PO2a) can be achieved under PO4b, the legal obligation 
would apply in practice to very few crematoria (around 100 out of 1.200) located mainly in 
two  Member  States  (DE,  HU)  and  abate  less  than  40%  of  mercury  emissions  from  EU 
crematoria.  Under  PO4c,  a  cost-benefit  ratio  between  1.10  or  1.33  (depending  on  the 
implementation  of  PO2a)  can  be  achieved,  but  the  legal  application  would  only  apply,  in 
practice,  to  an  additional  70  crematoria  compared  to  PO4b.  Hence,  above-mentioned 
disadvantages  may  put  into  question  in  particular  the  proportionality  principle,  especially 
when considering a dental amalgam phase-out (PO2a).            

72 

 
 
      
 
 
 
 
 
 
 
 
  
 
An  alternative  to  PO4  is  PO3  whereby  the  European  Commission  develops  a  non-legally 
binding  guidance  on  BAT  for  the  abatement  of  mercury  emissions  from  crematoria.  The 
advantage of PO3 provides room for manoeuvre for operators to make an informed choice on 
whether economic and administrative burden is feasible, dependent on their capacity.  
In  choosing  the  preferred  option,  account  should  be  taken  also  of  the  time  needed  to 
implement abatement technology in crematoria across the EU (typically, around 2-3 years for 
developing  appropriate  BATs  and  then  at  least  1-2  years  for  Member  States  to  implement 
them). 

8.1.3  PREFERRED POLICY OPTION FOR PROBLEM 3 

The  preferred  policy  options  for  Problem  Area  3  includes  both  the  introduction  in  the 
Mercury  Regulation  of  an  EU-wide  prohibition  of  the  manufacture  and  export  of  mercury-
containing lamps which are already prohibited from being placed on the internal market, by 
2026 and 2028 and a manufacture and export ban of dental amalgam aligned with the phase-
out  of  its  use  in  2025  (PO6b)  as  well  as  the  promotion  of  a  ban  under  the  Minamata 
Convention (PO5). It is to be noted that this manufacture and export ban, once implemented 
into the Mercury Regulation by this initiative, will also be transposed into Annex V (Part 2) 
to  the  PIC  Regulation,  as  has  been  done  with  the  full  list  of  MAPs  under  Annex  II  to  the 
Mercury Regulation. 

An  EU  ban  (PO6)  would  allow  the  EU  to  take  immediate  action  and  to  further  decrease 
export of MAPs independently from the unpredictable outcome of future negotiations at the 
international level (Minamata Convention). Such an action is a signal to  third countries that 
may wish to follow this approach and prohibit the sale/export of MAPs as well. It also sets an 
example  for  future  negotiations  under  the  Convention.  Furthermore,  such  action  would 
ensure  upholding  the  EU’s  credibility  vis-à-vis  the  objectives  set  out  in  the  EGD  and  EU 
Chemicals Strategy for Sustainability.   

However, recognising the risk of substitution of products that can no longer be exported from 
the  EU  but  still  sourced  from  elsewhere  in  the  world,  the  preferred  option  also  includes  a 
concerted push to reach a global agreement (at international level) on a ban of such products 
(PO5).  A global ban of such products  is  considered the most effective approach to  achieve 
the  maximum  reduction  of  product-related  mercury  use  and  emissions.  If  agreed  upon  by 
Parties to the Minamata Convention, it provides for a uniform phase-out of MAPs at global 
level. 

The  main  overlap  between  the  three  problem  areas  and  policy  options  relates  to  dental 
amalgam which is currently manufactured within the EU, and both used in the EU as well as 
manufactured  and  exported.  The  preferred  policy  option  is  coherent  in  that  a  phase-out  of 
dental  amalgam  use  in  the  EU  would  apply  from  2025,  simultaneously  to  a  ban  on  the 
manufacture and export to non-EU countries.  

8.1.4  OVERALL PREFERRED POLICY PACKAGE  

Overall, the combined preferred options would lead to the following impacts in the EU: 

  PO2a resulting in a cumulative reduction in mercury used in dental restorations in the 
EU  of  114  t  by  2035  (following  a  2025  phase-out)  and  additional  costs  of  using 
alternatives of €208 million in 2025 declining over time.  

73 

 
 
      
 
 
 
 
 
 
 
 
 
  PO3 (in combination with PO2a) resulting in estimated mercury emissions reductions 
of 14.5 kg in 2030, delivering human health benefits valued at €280,000 with costs to 
operators in 2030 estimated as total one-off capital costs of €10.3 million and annual 
operating costs of €0.32 million.  

Alternatively,  PO4b  (in  combination  with  PO2a)  resulting  in  estimated  mercury 
emissions  reductions  of  167  kg  (i.e.,  foregone  emissions  of  54  kg  stemming  from  a 
2025  phase-out  of  dental  amalgam  and  113  kg  from  controls  on  crematoria  greater 
than 4,000 cremations per  year) in 2030, delivering human health benefits valued at 
€2.2 million, and is estimated to result in total one-off capital costs of €15 million and 
annual operating costs of €0.46 million.  

  PO6b resulting in  a  reduction in demand for mercury for  mercury-containing lamps 
production in the order 0.8-1.5 t (export ban in 2026/2028). This would be associated 
with  potential  foregone  revenues  to  businesses  €97-190  million  (2026-2030; 
2026/2028 export ban). In addition, PO6a (2025) resulting in a reduction of mercury 
use for the production and export of dental amalgam in the order 30-180 t (export ban 
in 2025). This would be associated with potential foregone revenues to EU businesses 
€50-300 million (2025-2030).  

8.2.1.  REFIT 

In  line  with  the  Commission’s  commitment  to  better  regulation,  this  proposal  has  been 
prepared  inclusively  (3),  based  on  full  transparency  (3)  and  continuous  engagement  with 
stakeholders (3) with due regard to avoiding unnecessary burdens (2). It is based on the best 
available  evidence  (1),  referenced  in  the  document,  and  expert  knowledge  (1)  taking  into 
account the external feedback (1).  

The Mercury Regulation does not currently impose reporting (and associated reporting costs) 
on  operators  of  crematoria,  dental  practitioners  or  MAPs  producers.  Member  State 
Authorities  report  on  the  implementation  of  the  Regulation,  and  the  approximate  annual 
administrative burden of this overall reporting is moderate (30 000  – 100 000 EUR/p.a. for 
the whole EU) and is based on data that should already be available to authorities.  

PO2a (phase-out of dental amalgam from 2025) would  impact on dentists (all of whom are 
likely to be SMEs) across the EU as they would no longer be able to offer restorations using 
dental amalgam. However, impacts are expected to  be minimal  as there  has  already been a 
steady  transition  towards  phase  out  happening  in  recent  years  and  any  additional  costs 
associated with offering alternatives would be expected to be passed through to the consumer 
(and/or covered by social security systems and/or private healthcare).  

For crematoria, whilst there is uncertainty over how many SMEs are operating in the sector 
this  is  expected  to  be  high  (aside  from  those  that  are  publicly  run  most  of  the  rest  are 
expected to be SMEs.  

PO3 would be entirely voluntary and therefore no impacts on SMEs are expected. It would be 
up to the individual Member States and/or operators to decide whether or not to  implement 
controls.  

74 

 
 
      
 
 
 
 
 
 
 
 
 
 
 
PO4a  (mandatory  application  of  BAT  for  all  crematoria)  would  cover  all  crematoria  and 
therefore  impacts  on  SMEs  could  potentially  be  significant.  However,  all  additional 
compliance costs associated with installing mercury controls would be expected to be passed 
through  to  the  consumer  in  terms  of  fees  for  cremations,  as  they  are  already  done  in  many 
countries where abatement  is  already required. A mandatory option would also  entail  some 
administrative  burden  for  operators  (and  public  authorities)  for  ensuring  and  demonstrating 
compliance  e.g.  reporting  on  results  of  emissions  monitoring.  However,  it  is  assumed  that 
these would also be passed through to consumers alongside costs for installing and running 
abatement controls.  

PO4b (mandatory application of BAT for large crematoria only) would only cover the largest 
crematoria (above 4,000 cremations per year) thus excluding the smaller crematoria from any 
impacts (compared to PO4a this would reduce the number of crematoria potentially impacted 
from  1,500  to  just  under  130  crematoria).  For  those  crematoria  that  are  covered  by  PO4b, 
impacts could potentially be significant. However, all additional compliance costs associated 
with installing mercury controls would be expected to be passed through to the consumer in 
terms of fees for cremations, as they are already done in many countries where abatement is 
already  required.  A  mandatory  option  would  also  entail  some  administrative  burden  for 
operators (and public authorities) for ensuring and demonstrating compliance e.g., reporting 
on results of emissions monitoring. However, it is assumed that these would also be passed 
through to consumers alongside costs for installing and running abatement controls. 

PO4c (mandatory application of BAT for crematoria operating above ≥ 3000 cremations per 
year)  would  cover  170  out  of  1200  crematoria,  thus  excluding  the  smaller  crematoria  from 
any  impacts  (compared  to  PO4a).  For  those  crematoria  that  are  covered  by  PO4c,  impacts 
could  potentially  be  significant.  However,  all  additional  compliance  costs  associated  with 
installing mercury controls would be expected to be passed through to the consumer in terms 
of fees for cremations, as they are already done in many countries where abatement is already 
required.  Like  for  PO4b,  a  mandatory  option  would  also  entail  some  administrative  burden 
for  operators  (and  public  authorities)  for  ensuring  and  demonstrating  compliance  e.g., 
reporting on results of emissions monitoring. 

For PO5, a  global agreement would have an impact for  some SMEs that are manufacturing 
certain types of MAPs, namely some lamp types other than FLs for general lighting purposes. 
As  only  about  8%  of  current  HID  exports  would  be  affected  by  a  ban  the  relative  impact 
would be limited.  

For  PO6a  and  PO6b,  a  unilateral  MAP  export  ban  would  have  similar  effects  as  PO5.  In 
addition, a ban on the export of dental amalgam (only after a phase-out within the EU) would 
effectively end the production of amalgam by the four remaining EU producers, eliminating a 
large part of their current business. However, this would lead to a decrease of amalgam use in 
the EU in the order of 13 to 38 t. 

This  limits  the  potential  for  future  streamlining,  nevertheless  the  combination  of  measures 
designed to reduce the environmental footprint of European MAPs and aligning EU acquis on 
the placing on the market, import, export and manufacturing of MAPs will offer more legal 
certainty on the applicable rules (see Annex 9) for manufacturers and exporters and therefore 
ensure costs savings (2). 

75 

 
 
      
 
 
 
 
 
 
 
A revision of the Mercury Regulation will allow provisions that have become obsolete to be 
eliminated which would simplify its implementation (2).  

8.1. 

8.2.2  One-in-one-out 

The  proposed  options  will  not  bring  about  new  administrative  burdens  to  citizens,  and  the 
additional  burden  to  businesses  will  be  limited.  The  administrative  impact  of  the  amalgam 
phase-out (PO2a) and of measures addressing MAPs (PO5 and PO6) will bring limited cost 
savings – these could not be calculated in an exact manner as the current Mercury Regulation 
does  not  impose  direct  reporting  obligations  to  business  operators  (dental  practitioners, 
crematoria  operators  or  MAP  producers),  Member  States  report  on  mercury  emissions  in  a 
highly aggregated way.  

PO3 would not introduce any new administrative burdens for businesses, citizens or Member 
State  public  authorities  as  the  measure  would  be  voluntary  and  up  to  the  Member  States 
themselves (and/or operators) to decide whether to implement controls for crematoria using 
the developed guidance as a framework for any requirements.  

Should PO4a,PO4b or PO4c be retained as the preferred policy option, this would introduce 
new  administrative  burdens  to  both  crematoria  operators  and  Member  State  competent 
authorities, arising from the enforcement of the policy option.  

their 

For  PO4a,  in  addition  to  the  costs  of  implementing  and  operating  mercury  emissions 
abatement  systems  at 
installations,  crematoria  operators  would  face  added 
administrative  burdens.  This  would  arise  from  the  need  to  submit  information  on  their 
abatement systems  and any periodic emissions monitoring  and reporting to Member States’ 
competent authorities, who would also encounter a new administrative burden in processing 
such information. It has been assumed that costs to both operators and authorities would be 
comparable to administrative burdens incurred by the smallest medium combustion plants (1-
5  MWth)  under  Directive  (EU)  2015/2193  on  medium  combustion  plants83.  Administrative 
costs are estimated to amount to €400,000 to operators and €500,000 to authorities for PO4a 
(all crematoria) in 2030. 

For  PO4b,  in  addition  to  the  costs  of  implementing  and  operating  mercury  emissions 
abatement  systems  at  their  installations,  large  crematoria  operators  would  face  added 
administrative  burdens.  This  would  arise  from  the  need  to  submit  information  on  their 
abatement systems  and any periodic emissions monitoring  and reporting to Member States’ 
competent authorities, who would also encounter a new administrative burden in processing 
such  information.  It  is  assumed  that  costs  to  both  operators  and  authorities  would  be 
comparable to administrative burdens incurred by the smallest medium combustion plants (1-
5  MWth)  under  Directive  (EU)  2015/2193  on  medium  combustion  plants84.  Administrative 

83   Directive  (EU)  2015/2193  of  the  European  Parliament  and  of  the  Council  of  25  November  2015  on  the 
limitation  of  emissions  of  certain  pollutants  into  the  air  from  medium  combustion  plants  (OJ  L  313, 
28.11.2015, p. 1–19). 

84   Directive  (EU)  2015/2193  of  the  European  Parliament  and  of  the  Council  of  25  November  2015  on  the 
limitation  of  emissions  of  certain  pollutants  into  the  air  from  medium  combustion  plants  (OJ  L  313, 
28.11.2015, p. 1–19). 

76 

 
 
      
 
 
 
 
 
 
 
                                                           
 
costs are estimated to amount to €23.000 to operators and €28.000 to authorities for PO4b in 
2030.  For  PO4c,  administrative  costs  are  estimated  to  amount  to  €42,000  to  operators  and 
€53,000 to authorities in 2030. 

8.2.3.   PREFERRED INSTRUMENT 

Based on the analysis of the problems, the most appropriate instrument to address them is a 
revision of the current Mercury Regulation. 

9.  9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

9.1. 

9.1. Identification of monitoring needs 

Monitoring the implementation of a phase-out of the use of dental amalgam (PO2) will imply 
an obligation on Member States to undertake market surveillance and compliance checking in 
accordance  with  Regulation  (EU)  2019/102085.  Under  a  voluntary  application  of  abatement 
technology (PO3), no further monitoring obligations will be imposed at EU level, leaving the 
implementation  of  mercury  emission  abatement  technology  and  associated  monitoring  to 
Member  State  competent  authorities.  However,  in  case  of  mandatory  application  of 
abatement technology for crematoria (PO4), EU law would have to provide for monitoring, 
reporting obligations for operators of crematoria and administrative (information processing, 
inspections etc.) obligations for competent authorities. Similarly, regarding the prohibition to 
manufacture  and  export  of  MAPs  (i.e.,  CFLs  and  LFLs),  the  extension  of  Annex  II  to  the 
Mercury  Regulation  will  not  lead  to  an  ad-hoc  EU  obligation  to  monitor  implementation 
(PO5 and PO6). Any relevant information can be provided to the Commission via Member 
State  reports  on  the  implementation  of  the  Mercury  Regulation  (under  Article  18).  Jointly 
with the ongoing decarbonisation efforts, this initiative should translate into a progressively 
decreased presence of mercury in air, water and soil, to be tracked under the bi-yearly Zero 
Pollution Monitoring and Outlook Report. 

9.2. 

9.2. Identification of key indicators 

The key indicator for dental amalgam could be the amount of dental amalgam used in the EU. 
The  key  indicator  for  crematoria  could  be  the  uptake  of  mercury  abatement  techniques  in 
crematoria. For MAPs, no indicators are deemed necessary with a ban on their manufacture 
and export. 

85    Regulation  (EU)  2019/1020  of  the  European  Parliament  and  of  the  Council  of  20  June  2019  on  market 
surveillance  and  compliance  of  products  and  amending  Directive  2004/42/EC  and  Regulations  (EC) 
765/2008 and (EU) 305/2011 (OJ L169, 25.6.2019, p.1.). 

77 

 
 
      
 
 
 
  
 
 
 
 
 
 
 
 
 
 
                                                           
78 

 
 
      
 
 
 
 
 
Annex 1: Procedural Information 

10.  1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES 

The preparation of this file was led by DG Environment (ENV) and  comprises a review of 
Regulation (EU) 2017/852 on mercury, in accordance with its Article 19(1).  
The  Mercury  Regulation  is  the  most  important  legal  instrument  in  regulating  the 
environmental  impacts  of  mercury  pollution  by  addressing  the  entire  life  cycle  of  mercury. 
Article  19(1)  of  the  Mercury  Regulation  requires  the  Commission  to  review  the  following 
aspects: 

(a)  The need for the Union to regulation emissions of mercury and mercury compounds 

from crematoria; 

(b)  The  feasibility  of  a  phase  out  of  the  se  of  dental  amalgam  in  the  long  term,  and 
preferably by 2030, taking into account the national plans referred to in Article 10(3) 
and  whilst  fully  respecting  Member  State’  competence  for  the  organisation  and 
delivery of health services and medical care; and 

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

The  overall  “Mercury  Regulation  Review”  takes  into  account  the  feasibility  assessment  of 
phasing 
(2020)
1 and the study supporting the revision of Regulation (EU) 2017/852 on mercury2 in order to 
update  the  instrument  to  be  able  to  deliver  the  aims  and  targets  of  the  wide-ranging  and 
overarching policy aims as described in Section 2. 

amalgam 

dental 

out 

The DECIDE/Agenda Planning is the following: 

Mercury  –  Review  of  EU  law:  Revision  of  Regulation  (EU)  2017/852 
on mercury, and repealing Regulation (EC) No 1102/2008 

PLAN/2020/9940  

11.  ORGANISATION AND TIMING 

The  Mercury  Regulation  Review  initiative  feeds  into  objectives  set  out  in  the  European 
Green  Deal3,  the  Zero  Pollution  Action  Plan4  and  the  EU  Chemicals  Strategy  for 
Sustainability5.  The  Inception  Impact  Assessment  Roadmap  was  published  on  5  March 
2021 with a feedback period until 2 April 2021. 

1   Deloitte, Ineris, Wood (2020), Assessment of the feasibility of phasing-out dental amalgam – Final report 
2   Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury and 

repealing Regulation (EC) No 1102/2008 (OJ L137, 24.5.2017 p. 1). 

3   Communication from the Commission ‘The European Green’, COM(2019) 640 final,  11.12.2019. 
4   Communication from the Commission, ‘Pathway to a Healthy Planet for All EU Action Plan: 'Towards Zero 

Pollution for Air, Water and Soil' COM(2021) 400 final, 12.5.2021. 

5   Communication  from  the  Commission  ‘Chemicals  Strategy  for  Sustainability  -  Towards  a  Toxic-Free 

Environment’, COM(2020) 667 final, 14.10.2020. 

79 

 
 
      
 
                                                           
 
 
The  Inter  Service  Steering  Group  (ISSG)  for  the  Impact  Assessment  was  set  up  by  DG 
Environment. It included the following DGs and services: ENER (Energy), GROW (Internal 
Market, Industry, Entrepreneurship and SMEs), JRC (Joint Research Centre), RTD (Research 
and  Innovation),  SANTE  (Health  and  Food  Safety),  SJ  (Legal  Service)  as  well  as  TRADE 
(Trade). Meetings were organised between January 2021 and October 2022. 

The  ISSG  discussed  the  Inception  Impact  Assessment  as  well  as  the  Terms  of  Reference 
(ToR)  for  the  support  contract,  assisting  the  Commission  with  the  Impact  Assessment.  The 
ISSG  meetings  have  discussed  the  main  milestones  in  the  process,  in  particular  evidence 
gathering,  coherence  with  other  (ongoing  draft)  legislative  initiatives,  the  consultation 
strategy and main stakeholder consultation activities. The ISSG has been consulted regarding, 
and  has  given  input  to,  key  deliverables  from  the  support  study  and  the  draft  Impact 
Assessment report prior to its submission to the Regulatory Scrutiny Board (RSB). 

12.  CONSULTATION OF THE RSB 

An informal upstream meeting with the RSB took place on 11 January 2021. 

After final discussion with the ISSG, a draft of the Impact Assessment was submitted to the 
RSB on 14 November 2022 and discussed at a meeting with the RSB on 14 December 2022. 

Following the negative opinion of the RSB, changes were made to the Impact Assessment in 
order to reflect the recommendations of the Board.  

After another consultation of the ISSG, the Impact Assessment was re-submitted to the RSB 
on 17 February 2023. 

Following the positive opinion of the RSB (24 March 2023), additional changes were made 
to the Impact Assessment in order to reflect the recommendations of the Board. 

Table 1 presents an overview of the RSB’s comments and how these have been addressed. 

Table 1: How the RSB comments have been addressed 

General RSB comments 

How addressed 

Main findings 

1. The report is not sufficiently clear on the 
scale and the drivers of the problems. It does 
not 
the  dynamic 
baseline. 

sufficiently  describe 

 Supplementary 

information  on  dental 
amalgam  and  mercury  emissions  from 
crematoria  have  been  added  across  the 
whole report.  

 Using  additional  work  commissioned  to 
the consultant, the information describes in 
more  granular  detail  the  current  baseline 
situation  in  the  EU  and  in  each  Member 
State (p. 13 and 14), as well as the drivers 
and  scale  of  issues  associated  with  a 
phase-out of the use of dental amalgam (p. 
15),  mercury  emissions  from  crematoria 
(p.  19)  and  restriction  of  mercury-added 

80 

 
 
      
 
 
2.  The  report  does  not  present  a  clear, 
comprehensive  and  analytically  coherent 
cost benefit analysis. 

3.  The  report  does  not  provide  a  clear  and 
comprehensive  comparison  of  options.  It  is 
not  clear  how  the  choice  of  the  preferred 
options is supported by the analysis. 

products (MAPs) (pp. 23 and 24). 

 The  report  provides  a  clearer  and  a  more 
comprehensive  and  analytically  coherent 
picture  of  the  costs  and  benefits  of  each 
Policy Option (Section 7), using additional 
more  granular  Member  State 
level 
information. 

the 

 The  Policy  Options  were  restructured, 
separating 
to 
crematoria  from  the  options  related  to 
dental  amalgam.  Several  options  were 
screened out (Annex 7). 

options 

related 

and 

costs 

phase-out 

 The  link  between  impacts  of  a  dental 
of 
amalgam 
crematoria  emissions  abatement  is  clearly 
described in Sections 6.21, 6.2.2 and 7. 
 An  overview  of  costs  and  benefits 
(qualitative  and/or  quantitative  where  it  is 
not 
is 
to  quantify 
presented  in  a  tabular  format  (Table  12 
available 
and 
quantitative and qualitative information  in 
Sections 7 (and Annex 3). 

describing 

impacts) 

feasible 

13) 

all 

Specific RSB comments  

How addressed 

Way to improve 

the 

1.  The  report  should  clarify  and  further 
elaborate  on  the  scope  and  scale  of  the 
problems.  It  should  be  clear  that  the  term 
Mercury  Added Products also  covers dental 
amalgam.  It  should  specify  the  amount  of 
mercury  addressed  by 
initiative  as 
compared  to  the  total  amount  of  mercury 
released  from  or  used  in  other  human 
activities.  It  should  present  the  breakdown 
of amounts between dental amalgam (for use 
in  the  EU  and  for  exports),  crematoria 
emissions and the different MAP categories. 
The report should elaborate on the scale and 
reasons  for  the  continued  use  of  dental 
amalgam 
in 
particular  considering  the  availability  of 
safer alternatives and the phase-out in some 
Member  States.  It  should  explain  in  detail 
the  underlying  reasons  and  whether  those 
are  due  to  technical  constraints,  cost,  or 

in  certain  Member  States, 

81 

  Section  2  was  amended  to  improve  the 
description  of  the  scope  and  size  of  the 
problem  and  includes  a  breakdown  of 
amounts  of  mercury  addressed  by  the 
initiative (p. 11). 

  Section  1  provides  a  clear  definition  of 
the term mercury-added products (MAP), 
describing 
products 
addressed,  and  making  clear  that  dental 
amalgam  is  included  in  the  definition  of 
MAPs (p. 5 and 22). 

type 

the 

of 

  Section  2.1  describes  the  reasons  for 
which some Member States continue the 
use of dental amalgam and presents (in a 
tabular format Table 1 on pp. 13-14) the 
current and projected dental amalgam use 
per Member State. 

  Section 

price 
difference  between  dental  amalgam  and 

presents 

6.1.2 

the 

 
 
      
 
 
 
 
other  factors.  The  report  should  discuss  to 
what  extent,  the  differing  regulations  and 
standards  in  Member  States  lead  to  market 
fragmentation,  affect  the  functioning  of  the 
single market and contribute to the problem. 

mercury-free  alternatives  per  Member 
State  (Table  6  on  pp.  38  and  39)  and 
Section 2.2 provides an explanation as to 
why 
transboundary  effects  of  price 
differences  in  cremation  costs  between 
Member States are considered negligible.  

thanks 

towards 

in  crematoria 

2.  The  report  should  better  describe  the 
dynamic  baseline.  It  should  further  justify 
the  assumptions  on  the  uptake  of  emissions 
abatement technologies in view of the recent 
zero 
initiatives 
and  parallel 
pollution,  as  well  as  in  view  of  potential 
accelerated  deployment  of  mercury  vapour 
capture 
to  more 
affordable  solutions.  With  regard  to  MAPs, 
the  report  should  clarify  if  the  envisaged 
prohibition  of  additional  MAPs  under  the 
Minamata  Convention  is  included  in  the 
baseline.  It  should  explain  if  the  baseline 
considers 
towards 
the  accelerated  shift 
alternatives  to  mercury-containing  lamps 
technology.  It  should  also 
using  LED 
explain  why  the  option  related  to  seeking 
prohibition under the Minamata Convention 
is  not  considered  part  of  the  dynamic 
baseline.  It  should  also  consider  to  what 
extent non-legislative guidance type options 
form part of the dynamic baseline. 

situation 

expected 

  Sections  2.2,  6.2.1  and  6.2.2  provide  a 
more  detailed  description  of  the  current 
and 
of 
future 
crematoria  emissions  in  the  EU  and  per 
Member State, providing a description of 
the  current  and  expected  number  of 
crematoria  (Table  2  on  pp.  17-18  and 
Annex  5),  size/capacity  of  crematoria, 
these 
and  mercury  emissions 
crematoria.  

from 

  Section  5.1.3  presents  the  baseline  for 
MAPs  more  clearly  and  Section  1.2 
clarifies  the  envisaged  prohibition  of 
additional  MAPs  under  the  Minamata 
Convention (p. 10 and Annex 8). Section 
5.1.3  explains  why  such  a  prohibition 
cannot be considered as forming part of a 
dynamic  baseline  but  merits  from  being 
assessed as a real Policy Option (p. 31). 
  Section  5.1.3  also  provides  a  more 
the  baseline 
shift 

detailed  explanation  of 
considerations 
towards using LED technology. 

concerning 

the 

inclusion 

  Section 5 provides justified reasoning for 
the 
communication 
of 
campaigns  (dental  amalgam)  and  non-
(abatement 
legally  binding  guidance 
technologies  for  crematoria)  as  real 
Policy  Options  rather  than  as  part  of  a 
dynamic baseline. 

  Section 7 includes further assessment and 
an  overview  of  costs  and  benefits  in  a 
tabular  format  describing  all  available 
quantitative  and  qualitative  information, 
and  more  specifically  for  PO3  and  PO4 
(p. 45-48). 

  Sections  6.2.1,  6.2.2  and  7  present  and 
describe  in  more  detail  the  link  between 
impacts  of  a  dental  amalgam  phase-out 
and  costs  of  crematoria  emissions 
abatement. 

  Metrics  are  presented  in  a  more  specific 

and 

3.  The  report  should  present  a  clear, 
comprehensive 
analytically 
coherent cost benefit analysis. It should 
systematically present the available data 
and  estimates  for  each  option  and  sub-
option  in  a transparent  and  comparable 
impacts 
manner.  The  environmental 
should  be  monetised  (to  the  extent 
possible)  and  the  results  should  be 
brought into the cost benefit analysis. It 
should provide an overview of the costs 
impacts  and 
the  net 
and  benefits, 

82 

 
 
      
 
 
all 

quantitative 

Benefit  Cost  Ratio  of  each  option 
describing 
and 
qualitative  information.  It  should  be 
clearer on what  metrics  are used in  the 
analysis  and,  where  metrics  differ  or 
where  multiple  metrics  are  used, 
provide 
their 
comparability.  

information 

on 

and  clear  manner  and,  where  metrics 
differ or where multiple metrics are used, 
information  is  provided  on  their  (non-) 
comparability.  This 
specifically 
addressed in Section 7 and Annex 3. 

is 

have 

  Environmental 

been 
impacts 
monetised as much as possible and these 
and  been  integrated  into  the  cost-benefit 
analysis (see also response to point 6).  
  However,  for  PO2,  indirect  emissions  to 
soil  and  water  bodies  cannot  be 
robustly  quantified. 
accurately  nor 
Benefits  of  reduced  mercury  releases  to 
the  environment  can  only  be  valued  for 
other 
air 
to 
emissions 
no 
Therefore, 
environmental 
media. 
monetised  benefits  are 
significantly 
underestimated. 

but 

  Furthermore, 

in  mercury 
reductions 
emissions  to  air  will  result  in  reduced 
human exposure to atmospheric mercury. 
This  will  deliver  human  health  benefits. 
These  have  been  valued  by  applying 
EEA  damage  costs  to  predicted  mercury 
emission reductions. 
  However,  benefits  of 

in 
mercury exposure for dental practitioners 
robustly 
and 
cannot 
quantified  or  monetised 
so  health 
benefits are underestimated. 

reductions 

patients 

be 

  Therefore  there  are  limitations  to  the 
monetisation  of  several  environmental 
impacts  and  as  to  how  far  the  cost-
benefits  of  the  individual  options  can  be 
compared,  as  these  have  been  calculated 
using  different  methodologies.  These 
uncertainties  and  limitations  are  now 
better described in Annex 3 and 5.  

4.  The  report  should  be  clearer  on  the 
likelihood  that  a  ban  on  EU  exports  of 
MAPs will result in competing third-country 
producers  filling  the  emerging  gap  (for 
lamps  a  substitution  rate  of  50  to  90%  is 
assumed).  It  should  include  a  more  robust 
assessment  informed  by  expert  views  and 
other  available  evidence  regarding  the  risk 
that  the  substitute  third  country  lamps  will 
contain a higher amount of mercury and thus 
to  higher  continued  mercury 
contribute 

  Additional 

in 
included 
information 
the 
Section  6.3.2  and  Annex  7  on 
substitution  rate  assumed  as  well  as  the 
mercury content in substituted products.  
on 
competitiveness and estimated job losses 
have been included in Section 6.3.2 

information 

  Additional 

83 

 
 
      
 
pollution  in  third  countries.  The  report 
should  further  elaborate  the  analysis  on  the 
impact  of  the  stricter  options  on  the  EU 
manufacturers  of  dental  amalgam  and 
MAPs,  including  on  their  competitiveness, 
as well as the possible impact on job losses. 
5.  With  a  view  to  assessing  all  relevant  policy 
choices, the report should consider presenting an 
alternative  option  regarding 
the  mandatory 
abatement  of  mercury  emissions  by  including  a 
variant  with  a  capacity  threshold  set  at  3000 
(and  above).  This  seems  justified  given  the 
expected  additional  environmental  benefits  and 
the  fact  that  the  related.  Benefit  Cost  Ratio  Is 
close to the included variant with a threshold of 
4000  (and  above),  in  particular,  if  a  dental 
amalgam phase-out in 2025 is assumed. 
6.  The  report  should  further  develop  the 
impact  analysis.  The  environmental  and 
health  impacts  should  be  monetised  to  the 
extent possible. Where quantitative evidence 
is  lacking,  the  report  should  provide  the 
emphasising 
analysis 
qualitative 
uncertainties  and 
It  should 
assess in greater detail the impact on the EU 
manufacturers  of  amalgam  and  MAPs,  in 
particular  on  SMEs,  including  on  their 
international  competitiveness.  The  report 
should be clearer on the risk of substitution 
of  banned  EU  exports  with  third  country 
products  and  should  inform  whether  the 
remaining  third  country  producers  can  be 
expected  to  follow  similar  sustainability 
standards  as  EU  business.  It  should  clarify 
the  source  of  amalgam  for  residual  special 
medical  needs  in  case  such  exemption  is 
foreseen  when  phasing-out  of 
the  EU 
production.  It  should also better explain the 
impact  from  the  communication  campaigns 
and  how  the  voluntary  character  of  the 
option on guidance for crematoria on BATs 
is reflected in the analysis.  

limitations. 

  A  new  Policy  (sub)  Option  has  been 
included  in  Sections  5.2  and  6.2.2,  7,  8 
and  Annex  3  and  7  (PO4c)  whereby 
mandatory  application  of  abatement 
technology  would  be  set  for  crematoria 
with a capacity of ≤ 3000 cremations per 
year.  

  Further  assessment  provided  additional 
information  on  environmental  impacts 
for  all  options,  specifically  the  fate  of 
mercury from dental amalgam (p. 40-43).  
information  was 
lacking,  the  Impact  Assessment  filled 
data  gaps  with  qualitative  information. 
Uncertainties  and  limitations  are  better 
described in Annex 5.  

  Where  quantitative 

  Tables  12  and  13  on  the  comparison  of 
options  (Section  7)  have  been  re-drafted 
to  include  as  much  quantitative  data  as 
possible  and  are  accompanied  by  a 
narrative  on  the  comparison  of  options 
within problem areas (p. 55-57). 

  Whilst  the  Impact  Assessment  provides 
information 
on  EU  manufacturers 
including  employment,  export  volumes 
and values as well as mercury content of 
exported  MAPs,  the  assessment  of  the 
impacts  on  the  competitiveness  of  EU 
manufacturers  at  global  level  remains 
uncertain  due  to  unpredictable  global 
market responses. 

  Within  the  Impact  Assessment,  an  SME 
test  was  performed  in  accordance  with 
the  Better  Regulation  Guidelines.  The 
economic 
the 
preferred  Policy  Options  were  deemed 
limited 
This 
conclusion  results  from  several  factors, 
which  are  described  in  more  detail  in 

impacts  on  SMEs  of 

non-significant. 

to 

84 

 
 
      
 
 
Sections 6 and 7. 

  The  Impact  Assessment  clarifies  the 
potential source of mercury to be used in 
dental  amalgam  for  the  application  for 
specific  medical  conditions  in  Section 
5.2 (p. 33). 

  Sections  6.2.1  and  6.2.2 

for 

guidance 

include  a 
the  Policy 
cost/benefit  analysis 
Option 
for 
concerning 
crematoria  on  the  use  of  Best  Available 
including 
(BAT) 
Techniques 
assumptions made on the uptake of such 
a  non-legally  binding  measure.  It  also 
provides  a  cost/benefit  analysis  of  the 
option  of  mandatory  abatement/BAT  for 
crematoria 
different 
thresholds  depending  on  the  size  and 
capacity  of  crematoria  and  taking  into 
account a dental amalgam phase-out.   

divided 

into 

7.  The  report  should  further  develop  an 
assessment  of  the  effectiveness,  efficiency 
and  coherence  of  each  option,  as  well  as 
provide  a  detailed  and  clear  comparison  of 
the  alternative  options  using  the  results  of 
the cost benefit analysis. 

  Tables  12  and  13  on  the  comparison  of 
options  (Section  7)  were  re-drafted  to 
include  quantitative  data  and  where  not 
available,  qualitative 
information  on 
effectiveness  and  efficiency  of  Policy 
Options per Problem Area. 

  Section  7  also  assesses  the  coherence  of 
Policy  Options  between  Problem  Area  1 
and 2 (qualitatively and quantitatively).  
  Annex 7 includes a list of Policy Options 
discarded  at  different  stages  during  the 
Impact  Assessment  as  well  as  reasoned 
justification for doing so. 

lead 

  Annex  3  includes  a  comparison  for 
different  policy  sub  options  i.e.,  PO2a 
will 
in  mercury 
to  reductions 
emissions  from  crematoria  of  54  kg  (by 
2030),  whereas 
the  discarded  PO2b 
would lead to 31 kg (by 2030) and PO2c 
would  lead  to  3  kg  (by  2030).  Annex  3 
also  contains  comparisons  between  sub-
options  for  PO4,  taking  into  account 
PO2. 

8. The report should further substantiate the 
choice  of  the  preferred  options.  It  should 
clearly  explain  how  the  analysis  feeds  into 
the  choice  of  the  preferred  options.  In 
particular,  the  report  should  better  justify 
why  the  non-legally  binding  guidance  is 

  The  report  has  assessed  in  a  more 
detailed  and  granular  way  various 
options 
the  mandatory 
to 
abatement  of  mercury  emissions  from 
crematoria,  depending  on  the  size  and 
capacity of crematoria (Section 6.2.1 and 

related 

85 

 
 
      
 
preferred  over  the  mandatory  application  of 
BAT,  based  on  the  comparison  of  their 
effectiveness,  efficiency  and  coherence.  It 
should  also  explain  why  the  majority  view 
of  consulted  experts  was  not  followed.  The 
report  should  explain  if  the  effectiveness 
assessment  of  the  different  options  for 
reducing  emissions  from  crematoria  reflect 
the  legacy  of  mercury-containing  dental 
amalgam  in  the  population  before  phasing 
out and the related long-term latency effect. 
The report should also present the total costs 
and  benefits  and  cost-effectiveness  of  the 
preferred option(s). 

9.  The  report  should  systematically  refer  to 
the  views  of 
including 
diverging views, in particular with regard to 
the options, impact and comparison sections. 

stakeholders, 

6.2.2),  providing  additional  information 
as  to  the  cost-benefits  of  these  options 
(Table  12)  and  forming  the  basis  for  a 
more 
the 
preferred option.  

substantiated 

choice  of 

  In light of further analysis, Sections 6.2.1 
the  Policy  Options 
and  6.2.2  on 
from 
concerning  mercury  emissions 
crematoria  were  amended  and  include  a 
new  sub-option  assessing  the  impact  of 
mandatory  abatement  technologies  for 
crematoria  (using  capacity  thresholds  of 
> 4000 cremations per year). 

  Section 7 clarifies the impact of a dental 
on  mercury 
phase-out 
amalgam 
emissions  from  crematoria,  taking  into 
account the average longevity of a dental 
amalgam filling (legacy dental amalgam) 
(p. 34). 

  The  Impact  Assessment  describes  in 
more  detail  the  positions  of  relevant 
stakeholders  (in  Section  6),  in  particular 
concerning  the  preferred  Policy  Options 
as well as in Annex 2. 

13.  EVIDENCE, SOURCES AND QUALITY 

To  support  the  analysis  of  the  different  options,  the  European  Commission  awarded  a 
support contract to external experts. 

The consortium of consultants comprised:  

  BioIS and AQC – Policy impact assessment and links to wider policies  
  RPA – Stakeholder engagement 
 
  BioIS, AQC and GRS – Mercury policy and technical evaluation 

Ineris – Risk expertise 

Evidence was compiled from previous studies, as well as via specific desk studies and data 
collection performed as  sub-assignments, feeding into the overall  Impact  Assessment  work. 
Further  information  is  given  regarding  the  evidence  bases  compiled  by  the  external 
consultants in the following Annexes: 

  Annex 5 – Baselines 
  Annex 7 – Impact of shortlisted measures 

In addition, extensive consultation of stakeholders was carried out by the external experts, as 
detailed in: 

  Annex 2 – Stakeholder consultation synopsis 

86 

 
 
      
 
 
 
 
The external expert consultants worked in close cooperation with the European Commission 
throughout the different phases of the study, and particularly in the latter stages of assembling 
a  coherent  evidence  base  and  in  assessing,  screening  and  adjusting  policy  measures  and 
options. 

87 

 
 
      
 
 
 
 
 
 
Annex 2: Stakeholder Consultation 

INTRODUCTION 

The  Impact  Assessment  accompanying  the  Mercury  Regulation  Review  was  subject  to  a 
thorough  consultation  process.  This  included  a  variety  of  different  consultation  activities 
aimed  at  gathering  the  views  of  all  relevant  stakeholders  and  ensuring  that  the  views  of 
different organisations and stakeholder types were presented and considered. 

This  Annex  describes  the  consultation  activities  that  have  taken  place  and  presents  a 
summary of views. 

PART 1: DESCRIPTION OF CONSULTATION ACTIVITIES 

In  order  to  collect  primary  data  to  support  the  Impact  Assessment,  a  range  of  different 
consultation  activities  were  organised  to  engage  with  stakeholders.  Key  stakeholders  were 
consulted through a targeted questionnaire containing specialised questions in the three areas 
of  interest  (dental  amalgam,  mercury  emissions  from  crematoria  and  mercury-added 
products),  follow-up  interviews,  two  consultation  workshops  and  a  focus  group.  All  other 
relevant stakeholders were consulted through the public consultation questionnaire hosted on 
the “Have Your Say” portal. 

Inception Impact Assessment 

The 

Inception 

Impact 

Assessment

1  was  published  on  the  Commission’s  “Have  Your  Say”  interactive  portal  (38  responses; 
consultation period 5 March 2021 to 2 April 2021). 

Public consultation  

A  public  consultation2  was  published  online  via  the  Commissions’  “Have  Your  Say” 
interactive portal (146 valid responses; consultation period 8 February 2022 to 3 May 2022). 
The survey consisted of two sections: one section aimed at the general public, and the other 
aimed  at  those  with  technical  expertise  or  professional  experience  within  the  three  areas  of 
interest.  The  questionnaire  contained  66  questions,  most  of  which  directly  concerned 
gathering  stakeholder  opinions  on  the  use  of  mercury  in  dental  amalgam,  the  impact  of 
crematoria emissions, and perceptions about the export of mercury-added products. Questions 
for  technical  experts  aimed  at  gathering  insights  into  potential  policy  options.  Stakeholders 
were invited to submit attachments to their response, such as policy briefs or position papers. 

Targeted stakeholder survey 

A  targeted  stakeholder  survey  consisted  of  an  online  survey  of  a  more  detailed  nature  (36 
valid  responses;  15  December  2021  to  15  Aril  2022).  The  questionnaire  was  developed  in 
discussion and agreement with the European Commission including the ISSG. The structure 
and design of the TSS was similar to the public consultation and included a general section, 
followed by sections for each of the three areas of interest. These latter three sections were 
more technically detailed than the questions in the public consultation. The TSS was provided 
by  invitation  only,  to  stakeholders  with  a  known  stake  in  the  Mercury  Regulation.  The 

1   https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12924-Mercury-review-of-EU-

law_en  

2   Mercury – review of EU law (europa.eu) 

88 

 
 
      
 
                                                           
questionnaire  script  included  a  number  of  multiple-choice  questions.  Stakeholders  were 
invited to submit policy briefs, position papers, and other articles of interest as part of their 
response. 

In-depth interviews 

Interviews  (undertaken  via  telephone  or  video-conferencing  software)  were  undertaken  (13 
key stakeholders)  and provided in-depth  insight  into data gaps  in  all three areas  of interest. 
Stakeholders invited to an interview were selected from responses to the targeted survey, as 
well as other stakeholders with specific relevant knowledge.  Data obtained from interviews 
was used to validate and clarify concepts and issues identified elsewhere in the consultation. 

Because  many  interviewees  had  expert  roles  within  highly  specialised  sectors,  a  semi-
structured  interview  approach  was  applied.  This  approach  enabled  flexibility  in  discussing 
topics  relevant  to  each  stakeholder  type,  whilst  also  ensuring  the  structure  of  the  interview 
was maintained and the desired data collected. Interviews took place between March and July 
2022. 

Workshops 

Two  (online)  workshops  were  organised  and  conducted  (December  2021,  September  2022) 
with selected stakeholders to discuss the overall conclusions drawn from the study. The aim 
of  these  workshops  was  to  validate  the  findings  of  the  study,  discuss  and  refine  possible 
policy  options  available,  and  discuss  the  potential  impacts  of  the  policy  options.  Each 
workshop targeted about 40 participants. 

Stakeholders invited to participate in the workshops were carefully selected to ensure that the 
different sectors within all three areas of interest were adequately represented. 

Focus groups 

After  the  completion  of  the  public  consultation  and  targeted  stakeholder  survey,  a  focus 
group was organised, on mercury-added products. This focus group consisted of nine experts. 
The purpose of the focus group was to provide an expert opinion on the development of the 
policy options and took place on 14 June 2022. 

STAKEHOLDER GROUPS PARTICIPATING IN CONSULTATIONS 

This section outlines the type of respondents that participated in the survey.  As shown below 
49% (72/146) were EU Citizens, 19% (28/146) were companies, 14% (21/146) were NGOs.  
All other stakeholder types provided less than 10% of all responses. In total 87% (127/146) of 
responses  were  from  an  EU  Member  State,  and  13%  (19/146)  from  non-EU  countries.  
Significantly  more  responses  were  received  from  Germany  than  any  other  country  (34%, 
49/146),  with  Romania  being  the  second  highest  (19%,  28/146).    The  six  public  authority 
responses were from: the Swedish Chemicals Agency; the City of Gothenburg Environmental 
Administration;  the  Estonian  Ministry  of  the  Environment;  an  undeclared  French  authority; 
an Italian Joint Research Centre member, and the Norwegian Environment Agency. Tables 1 
and 2 below describe the types of stakeholder groups participating in the consultations whilst 
Table 3 indicated responses per country of origin. 

89 

 
 
      
 
 
 
 
Table 1: Respondent stakeholder types (OPC) 

Stakeholder types 

Stakeholder 
(count/total)) 

types 

(percentage  of 

total 

Academic/research institution 

Business association 

Company/business organisation 

Consumer organisation 

Environmental organisation 

EU citizen 

Non-EU citizen 

Non-governmental organisation (NGO) 

Other 

Public authority 

Total 

Totals may not equal 100% due to rounding 

Table 2: Respondent stakeholder types (TSS) 

1% (2) 

3% (5) 

19% (28) 

1% (2) 

1% (1) 

49% (72) 

5% (8) 

14% (21) 

1% (1) 

4% (6) 

100% (146) 

Stakeholder types 

Business association 

Company/business organisation 

EU Citizen 

Public authority 

Consumer organisation 

Stakeholder types (percentage of total (count/total)) 

39% (14/36) 

14% (5/36) 

3% (1/36) 

28% (10/36) 

3% (1/36) 

Non-governmental organisation (NGO) 

11% (4/36) 

Trade union 

Total 

3% (1/36) 

100% (36/36) 

Totals may not equal 100% due to rounding 

Table 3: Responses by country of origin 

Country 

Austria 

Belgium 

Bulgaria 

Cameroon 

Czechia 

Denmark 

Stakeholder 
(percentage 
(count/total)) 

types 
total 

of 

Country 

Stakeholder 
(percentage 
(count/total)) 

types 
total 

of 

1% (2) 

5% (8) 

1% (1) 

1% (1) 

1% (1) 

1% (2) 

Malaysia 

Malta 

Netherlands 

New Zealand 

Norway 

Poland 

90 

1% (1) 

1% (1) 

1% (1) 

1% (1) 

1% (2) 

2% (3) 

 
 
      
 
Estonia 

France 

1% (1) 

3% (4) 

Germany 

34% (49) 

Greece 

Hungary 

Iran 

Ireland 

Italy 

Total 

1% (1) 

1% (1) 

1% (1) 

1% (2) 

8% (11) 

Portugal 

Romania 

Slovakia 

Spain 

Sweden 

Ukraine 

United Kingdom 

United States 

2% (3) 

19% (28) 

1% (2) 

1% (1) 

3% (5) 

1% (1) 

7% (10) 

1% (2) 

100% (146) 

Figures 1 to 4 below illustrate the overall numbers of respondents with technical expertise or 
experience for the OPC, as well a breakdown of the proportion of the types of stakeholders 
for each of the three topics i.e., dental amalgam, crematoria and mercury-added products. 

Figure 1: Number of respondents with technical expertise or experience (OPC) 

Figure 2: Sub-sectors of operation: Dental Amalgam 

91 

 
 
      
 
 
 
 
 
 
 
Figure 3: Sub-sectors of operation: Crematoria 

Figure 4: Sub-sectors of operation: Mercury-added Products 

Figures 5 to 8 below illustrate the overall numbers of respondents with technical expertise or 
experience for the TSS, as well a breakdown of the proportion of the types of stakeholders for 
each of the three topics i.e., dental amalgam, crematoria and mercury-added products. 

Figure 5: Number of respondents with technical expertise or experience (TSS) 

92 

 
 
      
 
 
 
 
 
Figure 6: Sub-sectors of operation: Dental Amalgam 

Figure 7: Sub-sectors of operation: Crematoria 

Figure 8: Sub-sectors of operation: Mercury-added Products 

93 

 
 
      
 
 
 
 
PART 2: SUMMARY OF STAKEHOLDER VIEWS ON THE PROBLEMS AND OPTIONS 

This  section  summarises  the  view  of  different  types  of  stakeholders  with  regard  to  the  two 
problem areas as well as view on possible policy options. 

2.1. SUMMARY OF OPC RESULTS 

Dental amalgam:  A total of 95% (129/136) of the general public would choose a mercury 
free  material,  of  which  88%  (114/129)  stated  this  was  because  of  the  associated  lower 
potential  health  risk,  and  60%  (78/129)  stated  this  was  to  reduce  environmental  impact.  
Another  74%  (102/137)  stated  they  would  pay  more  for  non-mercury  materials  to  be  used, 
44%  (44/100)  suggested  they  would  pay  more  than  50%  increase  in  price.  Finally,  91% 
(125/137) believed amalgam be banned for use in dental fillings (except for a limited number 
of  cases  where  other  materials  cannot  be  applied  due  to  specific  health  conditions  of  the 
patient). 

Crematoria: A total of 61% (80/131) stated they were aware that mercury is emitted through 
crematoria  emissions,  77%  (101/131)  were  concerned  about  these  emissions,  and  86% 
(115/113) believed there should be an EU wide policy limit  to these emissions. Of experts, 
71% (5/7) believed emission limits should apply to all crematoria facilities. In addition, 88% 
(7/8)  of  experts  believed  state-of-the-art  emission  control  technologies  should  be  made 
obligatory across the EU.  

MAPs: A total of 56% (9/16) of experts believed there is no future for EU exports of MAPs, 
whereas 31% (5/16) believed there may be a future for a narrow range of specialist products. 
Of experts, 56% (9/16) believed demand for MAPs (that are banned in the EU but still being 
exported)  will  further  decrease  in  importing  countries;  only  19%  (3/16)  believed  it  will 
increase.  Finally,  47%  (7/15)  of  experts  believed  an  EU  export  ban  would  be  effective  in 
reducing the sale of MAPs in importing countries, whereas 33% (5/15) believed the exports 
need to be accompanied by global trade restrictions. 

Position  papers:  In  total  21  respondents  uploaded  a  total  of  33  additional  documents,  two 
were  removed  due  to  being  corrupt  &  irrelevant,  leaving  a  total  of  31  valid  documents 
(submitted  by  19  respondents)  suitable  for  analysis:  20  regarding  dental  amalgam,  one 
regarding  the  environmental  effects  of  mercury  emissions,  two  regarding  MAPs,  and  eight 
papers  on  general  issues  unspecific  to  the  three  interest  areas.  Of  the  19  respondents,  five 
were  from  Belgium,  seven  from  Germany,  one  from  Greece,  three  from  Sweden,  one  from 
Cameroon,  and  two  from  the  United  Kingdom.  Not  all  documents  were  position  papers, 
however information from non-position papers has been used elsewhere in the study. 

2.2. SUMMARY OF TSS RESULTS 

Dental amalgam: A total of 75% (3/4) of experts estimated the average decayed missing and 
filled  teeth  (DMFT)  score  for  those  under  18  years  of  age  to  be  0-1.1,  75%  (3/4)  believed 
those between 18-60 years of age to have a score of greater than 6.5, and 100% (3/3) believed 
those over 60 years of age to have a score greater than 6.5. Experts showed no consensus as 
to whether filling therapy would change in cost if alternatives to dental amalgam were used, 
although 67% (2/3) believed there would be an increase in cost. In total 60% (3/5) of experts 
believed  that  less  than  5%  of  all  ages  would  require  exemptions  from  the  phase-out,  20% 
(1/5) believed it would be 11%-25% of the population, and 20% (1/5) believed it would be 5-
10%. A total of 75% (6/8) of experts did not believe alternatives to amalgam are impractical 
to implement, and 88% (7/8) stated their patients ask for alternatives, and generally oppose 
the continued use of amalgam. 

94 

 
 
      
 
Crematoria:  A  total  of  75%  (12/16)  of  experts  believed  it  is  important  to  restrict  mercury 
emissions from crematoria, and 53% (9/17) stated that these emissions are already regulated 
in  their  Member  State  (41%  (7/17)  stated  regulations  were  not  in  place  in  their  country). 
Again, 75% (12/16) believed EU legislation is the right method to control mercury emissions. 
A total of 75% (12/16) believed crematoria should be treated similarly to other point emission 
sources  in  Europe  (31%  (5/16)  suggesting  through  application  of  minimum  emission  limit 
values, and 44% (7/16) stating through applied Best Available Techniques to reduce emission 
levels).  Furthermore,  65%  (11/17)  believed  emission  limits  should  apply  to  facilities  of  all 
sizes (35% (6/17) were in favour of lower limits for crematoria with lower numbers of annual 
cremations. A total of 88% of all experts (15/17) believed cremations are increasing in their 
Member  State,  and  82%  (14/17)  believed  emission  abatement  technologies  will  be  more 
common in the future. 

MAPs: Experts provided little to no data regarding TSS questions on MAPs.  

Position papers 

In  total,  13  respondents  provided  22  additional  documents.  Of  these,  only  eight  were 
classified  as  position  papers  (submitted  by  six  respondents).  The  remaining  14  documents 
provided  additional  sources  of  information  could  not  be  classified  as  position  papers.  
Therefore, a total of eight valid position papers have been included in the analysis.  In total, 
one  paper  covered  MAPs,  and  the  remaining  seven  papers  (submitted  by  five  respondents) 
covered  dental  amalgam.  In  total,  67%  (4/6)  of  those  who  submitted  a  position  paper  were 
business associations (the remainder were NGOs). A total of 33% (2/6) of respondents that 
submitted a paper were from Belgium, 33% (2/6) were from Germany, and 17% (1/6) were 
from Ireland, and the United Kingdom. 

95 

 
 
      
 
 
 
 
 
Annex 3: Who is affected and how? 

INTRODUCTION 

This Annex sets out the practical implications of the preferred policy package for the various 
types  of  stakeholders  concerned.  It  describes  the  actions  that  the  enterprises  or  public 
authority  might  need  to  take  in  order  to  comply  with  the  obligations  under  the  revised 
legislation and indicated the likely costs to be incurred in meeting those obligations, or where 
quantitative  information  is  not  available  the  nature  and  magnitude  of  such  costs.  It  also 
presents the implications for the public. 

14.  1.  PRACTICAL IMPLICATIONS OF THE INITIATIVE 

Dentists 

For  dentists,  the  economic  impact  of  a  phase-out  can  be  positive  or  negative  depending  on 
their skills in handling various filling materials. In the beginning, it may be negative but may 
become positive because of increased revenues (the handling and application of alternatives 
usually  is  more  expensive).  A  phase-out  of  dental  amalgam  is  also  expected  to  affect  costs 
that are borne by dentists for the collection and treatment of waste from amalgam separators. 
This cost will vary across Member States and within countries. However, these costs won’t 
disappear until the last amalgam filling has been removed. Maintenance cycles of separators 
do not depend on the amount of waste collected and would remain constant as well. 

Dental amalgam manufacturers 

The phase-out of amalgam use will impact on dental fillings manufacturers with a high share 
of  dental  amalgam  in  their  overall  production.  On  the  other  hand,  companies  with  a  high 
share  of  mercury-free  materials  in  their  production  will  gain  an  even  more  significant 
competitive  advantage.  The  supporting  study  to  the  impact  assessment  identified  only  four 
main EU companies producing encapsuled dental amalgam, therefore overall, the economic 
impact on the dental industry is expected to remain limited. 

Crematoria operators 

For crematoria, the preferred policy package could include the development of guidance for 
controlling  mercury  emissions  (PO3),  or  the  mandatory  abatement  of  mercury  emissions 
abatement at all crematoria (PO4a), or at large crematoria (PO4b; defined as those operating 
at annual capacity of 4,000 cremations per year and higher). Where crematoria are required 
(under PO4a and PO4b) or choose (under PO3) to install abatement equipment for reducing 
mercury  emissions  then  the  operators  will  incur  additional  capital  and  operational  costs 
although these would be expected to be passed on to the consumer in higher prices. Measures 
mandating  emissions  abatement  systems  at  crematoria  would  present  additional 
administrative costs to crematoria operators, arising from the need to submit information on 
their  abatement  systems  and  any  periodic  emissions  monitoring  and  reporting  to  Member 
State  competent  authorities.  Measure  PO3  would  present  an  additional,  albeit  limited, 
administrative  burden  on  European  institutions  in  the  development  of  guidance  for  the 
cremation sector, although this is not anticipated to be significant. 

96 

 
 
      
 
Mercury abatement technology manufacturers 

Where crematoria operators are required to install abatement equipment for reducing mercury 
emissions  (PO4a  and  PO4b),  or  choose  to  do  so  (PO3),  then  there  would  be  benefits  for 
manufacturers of such equipment as demand would increase. 

Businesses  that  are  currently  engaged  in  manufacturing  and/or  exporting  mercury-
added products that are no longer allowed to be placed on the EU market 

By the date specified for each product  group, businesses would have to stop manufacturing 
and export of MAPs. In case of an export ban in 2026 (halophosphate FLs)/ 2028 (all other 
relevant  MAPs),  an  export  value  in  the  order  of  €97  -  €190  million  would  be  lost.  This  is 
connected to several hundred jobs at two manufacturing sites in Poland and Germany. 

Depending on the time gap between an EU export ban and the entering into force of a global 
manufacture  and  trade  ban,  a  considerable  part  of  this  loss  will  likely  be  compensated  by 
increased  manufacture  and  sale  of  LED  products  and  by  the  general  increase  of  the  global 
lighting  market.  Export  losses  for  other  MAPs  than  lamps  could  not  be  quantified  but  are 
considered low. 

Products that have been legally imported into the EU for the purpose of distribution to non-
EU  countries  would  have  to  be  shipped  to  distribution  centres  outside  the  EU  before  the 
specified  phase-out  date  to  be  available  for  future  trade  with  non-EU  countries.  With  a 
sufficient  time  between  adoption  of  the  instruments  and  entering  into  force  such  secondary 
shipments  could  be  largely  avoided  by  directly  shipping  products  made  outside  the  EU  to 
distribution centres in third countries. 

Competent authorities 

The  preferred  policy  package  is  not  expected  to  have  any  significant  impacts  on  public 
authorities. The phase-out of dental amalgam would apply uniformly across the EU. Member 
States  may  choose  to  undertake  some  level  of  surveillance  to  ensure  that  the  phase-out  is 
being  implemented  across  their  territory  but  this  would  not  be  mandated  by  the  preferred 
policy  package.  Overall,  a  phase-out  should  have  a  positive  economic  impact  on 
municipalities  (and  taxpayers),  as  it  will  reduce  the  environmental  costs  associated  with 
managing mercury pollution from dental amalgam. 

For  crematoria,  PO4a  and  PO4b  mandating  application  of  abatement  emissions  systems 
would  result  in  additional  administrative  burden  on  Member  State  competent  authorities 
arising  from  the  need  to  process  information  submitted  by  crematoria  operators  on  their 
abatement systems and any periodic emissions reporting. The development of guidance to the 
sector (PO3) would present no such burden. 

Concerning MAPs, the policy package does not have an impact on public authorities. 

The public 

97 

 
 
      
 
The phase-out of dental amalgam use would have two main impacts on the general public: 

1.  It has implications on the dental health treatment options available in that amalgam 

would no longer be available (except for certain medical exemptions). This may have 
cost implications in that, at least in the short term, there is an additional cost for 
consumers of amalgam alternatives.  

2.  Human health and environmental benefits from the phase-out of the use of dental 
amalgam. This includes a reduction in associated emissions from crematoria.  
Where  crematoria  are  required  to  install  abatement  equipment  for  reducing  mercury 
emissions (PO4a and PO4b), or choose to do so (PO3), then the overall costs to consumers of 
cremations may rise slightly. However, there would also be human health and environmental 
benefits from a reduction in emissions and exposure.  

Concerning MAPs, the policy package does not have an impact on the European public. 

Other 

There is an impact for the public in importing non-EU countries. Banning the export of EU 
products will lead to decreased supply of MAPs to national markets which may cause higher 
product prices in the short-term. Also, substituting imports from third countries are expected 
to  have higher mercury  contents per unit, so that the total  net  mercury  content of imported 
products  may  increase  in  the  short-term.  Such  a  potentially  negative  effect  is  likely  to  be 
compensated  due  to  a  globally  observed  decreasing  demand  for  MAPs,  notably  lamps  and 
would be eliminated once a global ban under the Minamata Convention enters into force. 

15.  2.  SUMMARY OF COSTS AND BENEFITS 

15.1.  Policy Option 2a – Dental amalgam phase-out in 2025 

Description 

Amount 

Comments 

I. Overview of Benefits (total for all provisions) – PO2a 

Establish  a  2025 
legally 
binding  end-date  for  the  use 
of dental amalgam in the EU 

Direct benefits 
reductions 

Estimated  cumulative 
in  direct 
mercury releases by 2030 of 3.1 t to air, 3.4 t to 
soil, 0.6 t to waterbodies, 2.6 t to wastewater, and 
42.1 t sequestered or recycled. 

Indirect  emissions  to  soil  and  water  bodies 
not feasible to quantify. Benefits of reduced 
mercury  releases  to  the  environment  can 
only  be  valued  for  emissions  to  air  but  no 
other  environmental  media.  Therefore, 
monetised 
significantly 
underestimated.  

benefits 

are 

Reduced  mercury  exposure 
to  dental  practitioners  and 
patients 

Reduction 
waste generation 

in 

hazardous 

In  the  absence  of  PO2a,  the  expected  amount  of 
mercury put into teeth will be about 9.3 t in 2025. 

Significant  reductions  in  mercury  vapour 
exposure for dental practitioners. 

In  the  absence  of  PO2a,  the  expected  amount  of 
in  amalgam 
mercury  wasted  and  collected 
separators will be about 11 t in 2025. 

Significant  reductions  in  hazardous  waste 
generation. 

Indirect benefits 

Compliance cost reductions  Reduced  costs  associated  with  dental  amalgam 
waste 
authorised  waste 
by 
management  establishments  or  undertakings) 

(collected 

Not  possible  to  robustly  quantify.  These 
benefits  would  be  realised  once  all  legacy 
amalgam restorations have been disposed of. 

98 

 
 
      
 
Reduced  mercury  emissions 
from crematoria  

Public  health  &  safety  and 
health systems 

borne by dentists. 

The  majority  of  amalgam  in  the  population 
would  be  replaced  /  disposed  of  within 
around 15 years.  

PO2a  will 
emissions from crematoria of 54 kg (by 2030)  

to  reductions 

in  mercury 

lead 

Note:  Discarded  PO2b  would  lead  to  31 kg  (by 
2030) and PO2c would lead to 3 kg (by 2030). 

For  PO2a,  human  health  benefits  valued  at 
€900,000  as  a  result  of  reduced  mercury 
emissions from crematoria in 2030. 

in 

reduced  human  exposure 

Reductions in  mercury emissions to air will 
result 
to 
atmospheric  mercury.  This  will  deliver 
human  health  benefits.  These  have  been 
valued  by  applying  EEA  damage  costs  to 
predicted mercury emission reductions. 
Benefits  of  reductions  in  mercury  exposure 
for  dental  practitioners  and  patients  cannot 
be  robustly  quantified  or  monetised  so 
health benefits are underestimated.  

II. Overview of costs – PO2a 

Citizens/Consumers  

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

Compliance 
costs 

0 

Direct costs 

Indirect costs 

recurrent 
The 
costs 
will 
depend  on  the 
reimbursement 
dental 
of 
by 
treatment 
social 
state 
security 
and 
private  medical 
insurance.  

the 
impacts 
from 
on 

Not  possible  to 
accurately 
quantify 
cost 
resulting 
pressure 
manufacturers 
of 
fillings 
dentists 
amalgam 
products. 

amalgam 
and 
using 

0 

0 

of 

Increased 
costs 
dental 
treatment 
estimated  at 
€208 
million 
in 
the first year 
of  phase-out 
(in 2025). 

Admin costs  Direct costs 

Indirect costs 

0 

0 

0 

0 

0 

0 

99 

0 

0 

Short-term 
limited 
and/or 
in 
increase 
dentist 
fees, 
most  likely  to 
be  passed  on  to 
state  or  private 
health 
insurance.  

0 

0 

0 

0 

0 

Not  possible 
to  accurately 
quantify 
the 
cost 
impacts 
resulting  from 
increased 
pressure 
the 
health 
insurance 
systems 
across the EU. 

on 
state 

0 

0 

 
 
      
 
 
 
 
 
 
 
15.2.  Policy Option 3 – EU guidance on emissions abatement in crematoria 

The following tables provide a summary of the costs and benefits of Policy Option 3. 

Description 

I. Overview of Benefits (total for all provisions) – PO3 

Amount 

Direct benefits 

Comments 

EU  guidance  on  emissions 
abatement in crematoria 

N/A 

Indirect benefits 

Quality of natural resources  Mercury emissions reductions of 17kg (6-29kg). 

Public  health  &  safety  and 
health systems 

Mercury  emissions  reductions  of  14kg  (3-27kg) 
when combined with a 2025 phase-out (PO2a) 

Human  health  benefits  valued  at  €300,000 
(€100,000-€600,000)  as  a  result  of  reductions  in 
emissions  of  mercury,  PM2.5,  lead,  cadmium, 
arsenic, chromium, nickel and dioxins and furans. 

Human  health  benefits  valued  at  €300,000 
(€100,000-€500,000)  as  a  result  of  reductions  in 
emissions  of  mercury,  PM2.5,  lead,  cadmium, 
arsenic, chromium, nickel and dioxins and furans, 
when combined with a 2025 phase-out (PO2a). 

is  a  possible 
A  consequence  of  PO3 
reduction  in  mercury  emissions  to  air.  This 
has 
of 
benefits 
environmental quality and human health. 

indirect 

terms 

in 

Any  reduction  in  mercury  emissions  will 
result  in  reduced  deposition  of  atmospheric 
mercury  to  soil  and  waterbodies.  It  is  not 
possible  to  robustly  quantify  the  reduced 
deposition or to put an economic value on it. 

in 

reduced  human  exposure 

Reductions in  mercury emissions to air will 
result 
to 
atmospheric  mercury.  This  will  deliver 
human  health  benefits.  These  have  been 
valued  by  applying  EEA  damage  costs  to 
predicted mercury emission reductions. 

II. Overview of costs – PO3 

Citizens/Consumers  

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

Direct costs 

0 

0 

€10.3 million 

€320,000 
year 

per 

0 

Compliance 
costs   

Indirect costs  Costs 

to 

0 

operators 
are  passed 
on 
to 
consumers. 
Not 
quantified. 

Admin costs  

0 

Direct costs 

Indirect costs 

0 

0 

0 

0 

0 

0 

0 

Limited cost 
to 
institutions 
to  develop 
guidance 

0 

0 

0 

0 

100 

0 

0 

0 

0 

 
 
      
 
 
 
 
 
 
15.3.  Policy Option 4a – Mandatory abatement of mercury emissions at all 

crematoria 

The following tables provide a summary of costs and benefits of Policy Option 4a. 

I. Overview of Benefits (total for all provisions) – PO4a 

Description 

Amount 

Direct benefits 

Comments 

Mandatory 
abatement  of 
mercury  emissions  at  all 
crematoria 

N/A 

Indirect benefits 

Quality of natural resources  Mercury  emissions  reductions  of  314kg  (105-

542kg). 

Public  health  &  safety  and 
health systems 

Mercury  emissions  reductions  of  269kg  (50-
496kg)  when  combined  with  a  2025  phase-out 
(PO2a) 

Human  health  benefits  valued  at  €6.1 million 
(€2.2 million-€10.4 million)  as  a 
result  of 
reductions  in  emissions  of  mercury,  PM2.5,  lead, 
cadmium, arsenic, chromium, nickel and dioxins 
and furans. 

Human  health  benefits  valued  at  €5.4  million 
(€1.3 million-€9.6  million)  as  a 
result  of 
reductions  in  emissions  of  mercury,  PM2.5,  lead, 
cadmium, arsenic, chromium, nickel and dioxins 
and  furans,  when  combined  with  a  2025  phase-
out (PO2a). 

A  consequence  of  PO4a  is  a  reduction  in 
mercury  emissions  to  air.  This  has  indirect 
benefits  in  terms  of  environmental  quality 
and human health. 

Any  reduction  in  mercury  emissions  will 
result  in  reduced  deposition  of  atmospheric 
mercury  to  soil  and  waterbodies.  It  is  not 
possible  to  robustly  quantify  the  reduced 
deposition or to put an economic value on it. 

in 

reduced  human  exposure 

Reductions in  mercury emissions to air will 
result 
to 
atmospheric  mercury.  This  will  deliver 
human  health  benefits.  These  have  been 
valued  by  applying  EEA  damage  costs  to 
predicted mercury emission reductions. 

II. Overview of costs – PO4a 

Citizens/Consumers  

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

Direct costs 

0 

0 

€182 million 

Indirect costs  Costs 

to 

0 

Compliance 
costs   

Admin costs   Direct costs 

Indirect costs 

operators 
are  passed 
on 
to 
consumers. 
Not 
quantified. 

0 

0 

0 

0 

0 

0 

0 

101 

€5.7 million per 
year 

0 

0 

0 

0 

0 

€400,000 

0 

0  

0 

€500,000 

0 

 
 
      
 
 
 
 
 
 
15.4.  Policy Option 4b – Mandatory abatement of mercury emissions at large 

crematoria (operating at an annual capacity of ≥4,000 cremations per year) 

The following tables provide a summary of costs and benefits for Policy Option 4b. 

I. Overview of Benefits (total for all provisions) – PO4b 

Description 

Amount 

Direct benefits 

Comments 

N/A 

Mandatory 
abatement  of 
mercury  emissions  at  large 
crematoria  (operating  at  an 
annual  capacity  of  ≥4,000 
cremations per year) 

Indirect benefits 

Quality of natural resources  Mercury  emissions  reductions  of  141kg  (70-

210kg). 

Mercury  emissions  reductions  of  113kg  (33-
182kg)  when  combined  with  a  2025  phase-out 
(PO2a) 

A  consequence  of  PO4b  is  a  reduction  in 
mercury  emissions  to  air.  This  has  indirect 
benefits  in  terms  of  environmental  quality 
and human health. 

Any  reduction  in  mercury  emissions  will 
result  in  reduced  deposition  of  atmospheric 
mercury  to  soil  and  waterbodies.  It  is  not 
possible  to  robustly  quantify  the  reduced 
deposition or to put an economic value on it. 

Public  health  &  safety  and 
health systems 

Human  health  benefits  valued  at  €2.7 million 
(€1.3 million-€3.9 million) 
result  of 
reductions  in  emissions  of  mercury,  PM2.5,  lead, 
cadmium, arsenic, chromium, nickel and dioxins 
and furans. 

as 

a 

in 

reduced  human  exposure 

Reductions in  mercury emissions to air will 
result 
to 
atmospheric  mercury.  This  will  deliver 
human  health  benefits.  These  have  been 
valued  by  applying  EEA  damage  costs  to 
predicted mercury emission reductions. 

Human  health  benefits  valued  at  €2.2  million 
(€0.7 million-€3.5  million)  as  a 
result  of 
reductions  in  emissions  of  mercury,  PM2.5,  lead, 
cadmium, arsenic, chromium, nickel and dioxins 
and  furans,  when  combined  with  a  2025  phase-
out (PO2a). 

II. Overview of costs – PO4b 

Citizens/Consumers  

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

Direct costs 

0 

0 

€14.9 million 

Indirect costs  Costs 

to 

0 

Compliance 
costs   

Admin costs   Direct costs 

Indirect costs 

operators 
are  passed 
on 
to 
consumers. 
Not 
quantified. 

0 

0 

0 

0 

0 

0 

0 

102 

€460,000 
year 

per 

0 

0 

0 

0 

0 

€23,000 

0 

0  

0 

€28,000 

0 

 
 
      
 
 
 
 
 
 
15.5.  Policy Option 4c – Mandatory abatement of mercury emissions at large 

crematoria (operating at an annual capacity of ≥3,000 cremations per year) 

The following tables provide a summary of costs and benefits for Policy Option 4c. 

I. Overview of Benefits (total for all provisions) – PO4c 

Description 

Amount 

Direct benefits 

Comments 

N/A 

Mandatory 
abatement  of 
mercury  emissions  at  large 
crematoria  (operating  at  an 
annual  capacity  of  ≥3,000 
cremations per year) 

Indirect benefits 

Quality of natural resources  Mercury  emissions  reductions  of  191kg  (82-

302kg). 

Mercury  emissions  reductions  of  156kg  (39-
268kg)  when  combined  with  a  2025  phase-out 
(PO2a) 

A  consequence  of  PO4c  is  a  reduction  in 
mercury  emissions  to  air.  This  has  indirect 
benefits  in  terms  of  environmental  quality 
and human health. 

Any  reduction  in  mercury  emissions  will 
result  in  reduced  deposition  of  atmospheric 
mercury  to  soil  and  waterbodies.  It  is  not 
possible  to  robustly  quantify  the  reduced 
deposition or to put an economic value on it. 

Public  health  &  safety  and 
health systems 

Human  health  benefits  valued  at  €3.6 million 
(€1.6 million-€5.7 million) 
result  of 
reductions  in  emissions  of  mercury,  PM2.5,  lead, 
cadmium,  arsenic, chromium, nickel and dioxins 
and furans. 

as 

a 

in 

reduced  human  exposure 

Reductions in  mercury emissions to air will 
result 
to 
atmospheric  mercury.  This  will  deliver 
human  health  benefits.  These  have  been 
valued  by  applying  EEA  damage  costs  to 
predicted mercury emission reductions. 

Human  health  benefits  valued  at  €3.0  million 
(€0.9 million-€5.1  million)  as  a 
result  of 
reductions  in  emissions  of  mercury,  PM2.5,  lead, 
cadmium, arsenic, chromium, nickel and dioxins 
and  furans,  when  combined  with  a  2025  phase-
out (PO2a). 

II. Overview of costs – PO4c 

Citizens/Consumers  

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

Direct costs 

0 

0 

€24.9 million 

Indirect costs  Costs 

to 

0 

Compliance 
costs   

Admin costs   Direct costs 

Indirect costs 

operators 
are  passed 
on 
to 
consumers. 
Not 
quantified. 

0 

0 

0 

0 

0 

0 

0 

103 

€780,000 
year 

per 

0 

0 

0 

0 

0 

€42,000 

0 

0  

0 

€53,000 

0 

 
 
      
 
 
 
 
 
 
15.6.  Policy Options 6a and 6b – EU ban on the manufacture and export of dental 

amalgam by 2025 and MAPs by 2026/2028 

The following tables provide a summary of costs and benefits for Problem 3 for the options 
included in the preferred policy package. 

I. Overview of Benefits (total for all provisions) – PO6a and PO6b 

Description 

Amount 

Direct benefits 

Comments 

export 

EU  ban  on  the  manufacture 
and 
dental 
amalgam  by  2025  (PO6a) 
and  MAPs  by  2026/2028 
(PO6b) 

of 

Quality of natural resources 

PO6a  will  lead  to  a  decrease  of  demand  for 
mercury for dental amalgam in the order of 30 to 
180 t between 2025 and 2030 
PO6b will lead to decreased demand for mercury 
for MAP production of 0.8 to 1.5 t between 2026 
and 2030 

Indirect benefits 

PO6a  will  lead  to  a  reduction  of  mercury  in 
exported  dental  amalgam  in  the  order  of  30  to 
180 t between 2025 and 2030. 
PO6b  will  lead  to  a  reduction  of  mercury  in 
exported MAPs of 0.8 to 1.5 t and consequently a 
reduction  of  mercury  into  general  waste  streams 
of  0.7  to  1.3  t.  In  importing  third  countries,  the 
net  reduction  may  be  smaller  or  even  negative 
to 
(increase  of 
possible substitution by MAP imports from non-
EU countries: -0.3 to +1.1 t (PO6b). 

total  mercury  content)  due 

Public  health  &  safety  and 
health systems 

Lower risk of exposure to mercury due to contact 
with waste or contaminated land, if non-EU MAP 
substitution is minimal. 

Conduct of business 

PO6a will lead to a higher demand  for  mercury-
free filling materials 
PO6b  will  lead  to  a  significant  increase  in  sales 
of  LED  lamps,  luminaires  and  lighting  systems 
(but lower increase than in policy option PO5)  

A  direct  consequence  of  decreased  demand 
for MAP production is a significant decrease 
of mercury in exported products. 

the 

In importing third countries: 
PO6a  would  lead  to  positive  net  impact 
depending  on 
level  of  substituting 
imports from non-EU countries 
PO6b would lead to a positive net impact if 
an  EU  ban  is  closely  followed  by  a  global 
ban. 

Reduced input into the general waste stream 
will  lessen  the  risk  of  exposure  to  mercury 
for  the  population  living  close  to  waste 
disposal  sites  or  directly  involved  in  waste 
management (in importing third countries). 

Dental  amalgam  no  longer  provided  by  EU 
manufacturers  may  partially  be  substituted 
by  products  (incl.  amalgam)  from  non-EU 
manufacturers 
Possible  risk  of  short-term  negative  impact 
due  to  non-EU  substituting  MAP  imports, 
limiting 
for  mercury-free 
alternatives. 

demand 

II. Overview of costs –PO6a and PO6b 

Citizens/Consumers  

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

0 

0 

PO6a 
Export 
ban  2025 
(Dental 
amalgam) 

Direct costs 

Loss 
of 
revenues:  €50 
to €300 million 
(retail 
value, 
revenue 
considerably 
smaller)  (2025 
– 2030) 

104 

0 

0 

0 

 
 
      
 
 
 
0 

0 

0 

0 

Indirect costs 

0 

Dental  amalgam: 
short-
possible 
term 
increased 
costs  for  dental 
in 
restorations 
third 
countries 
due  to  decreased 
supply. 

0 

0 

PO6b 
Export 
ban  2026/ 
2028 
(MAPs) 

Direct costs 

Indirect costs 

0 

of 
Loss 
revenues:  €97 
to €190 million 
(2026-2030) 

0 

0 

0 

0 

0 

0 

0 

Dental  amalgam: 
short-
possible 
term 
increased 
costs  for  dental 
in 
restorations 
third 
countries 
due  to  decreased 
supply. 

105 

 
 
      
 
 
 
Annex 4: Analytical methods 

INTRODUCTION 

Due  to  the  two  distinct  issues  covered,  the  Impact  Assessment  is  not  based  on  a  single 
methodology, but rather on a variety of qualitative and quantitative approaches that have been 
synthesised.  Most  Policy  Options  will  likely  induce  various  magnitudes  of  effects  on 
operators,  associated  manufacturers,  Member  States’  Authorities,  National  Health  Care 
Systems and the general public, which is very difficult to quantify at high accuracy levels at 
an overall EU level. The assumptions and methods used for the assessment of these impacts 
are described in the respective sections in Annex 7. 

The following summary provides information on the analytical methods used. 

1.  OVERVIEW OF TASKS AND METHODS 

The  methods  employed  were  developed  according  to  the  European  Commission’s  Better 
Regulation  Guidelines  and  Toolbox,  adapted  based  on  the  time  available  to  complete  the 
Impact  Assessment  support  work  and  the  report  team’s  wealth  of  practical  experience  in 
delivering Impact Assessments. 

The  Impact  Assessment  support  work  was  structured  around  seven  tasks,  represented  in 
Figure 1. 

Figure 1: Overview of the tasks of the Impact Assessment support work 

Each task was based on and/or followed the EC’s Better Regulation Guidelines and Toolbox. 

106 

 
 
      
 
 
 
 
 
These tasks are described below: 

  Task 1: Define and clarify the problem to be addressed 

This tasked aimed at setting the scene by developing an overall problem definition as 
well  as  specific  definitions  for  each  of  the  three  focus  areas  of  this  study  (dental 
amalgam, mercury emissions from crematoria and mercury-added products). 

  Task 2: Construct the baseline scenario against which impacts of options will be 

assessed 
The  study  considered  how  the  status  quo  would  likely  evolve  and  based  on  that 
developed  baseline  scenarios,  which  form  the  basis  for  comparing  the  impacts  of 
different policy options (developed, assessed and compared under tasks 3, 4 and 5). 

  Task 3: Develop policy options 

Whilst  the  baseline  was  being  defined,  the  study  team  engaged  with  the  European 
Commission  and  stakeholders  to  develop  a  longlist  of  policy  options  that  could 
address  the  problems  identified,  taking  into  account  the  problem  drivers.  As  not  all 
policy measures or actions were viable, the external expert team defined the screening 
criteria to shortlist the most relevant options. 

  Task 4: Assessment of impacts of identified options 

A  longlist  of  possible  impacts  was  developed  and  screened.  From  these,  impact 
categories were identified as likely to be significant for a  more in-depth assessment. 
Across these impact categories, different types of costs and benefits were considered. 

  Task 5: Comparison of the options and concluding results 

The  evidence  on  impacts,  costs  and  benefits  was  employed  to  compare  policy 
measures  and  options  and  develop  conclusions  as  to  whether  a  given  option  would 
contribute  to  achieving  set  objectives  and  generate  benefits  that  would  likely 
outweigh costs. 

  Task 6: Stakeholder consultations (public and targeted) 

Stakeholder engagement was a horizontal task and key to this support study, feeding 
into  all  of  the  aforementioned  tasks.  The  consultation  activities  and  data  analysis 
carried out in this study included an open consultation, a targeted survey, workshops, 
focus groups and interviews.  

  Task 7: Additional targeted assessment 

This  task  aimed  at  allowing  the  external  expert  team  to  provide  ad-hoc  additional 
targeted assessments addressing the feedback received from the Regulatory Scrutiny 
Board.  This  task  addressed  the  need  for  additional  information,  complementing  the 
information on dental amalgam  and mercury emissions from crematoria, to enable a 
more detailed assessment of the types and magnitude of the impacts with respect to a 
phase-out of the use of dental amalgam (in terms of costs borne by stakeholders) and 
mercury emissions from crematoria (in terms of geographical distribution). 

Multiple methods were employed across these tasks, which are presented in Table 1. 

107 

 
 
      
 
 
 
 
 
 
 
 
  
Table 1: Overview of the approach for the synthesis of evidence 

Element 

Desk research 

research 

Field 
(survey, 
interviews  and 
public 
consultation 
submissions) 

Approach 

•  Clearly set out what sources were used giving an indication of the reliability of 
the data sources and possible bias (for example, date of the report, geographical 
coverage,  which  stakeholder  group  commissioned/produced  it,  whether  it  was 
peer reviewed or not.) 

• 

• 

Indicate what specific data gaps were there (e.g., lack of studies at the national 
level, or a lack of recent studies etc.) and the approach taken to fill them. 

Indicate  which  stakeholders  were  asked  about  each  topic  and  what  research 
tools were used (interviews/surveys). 

•  Report  on  the  responses  provided  where  relevant  or  cross-reference  to  the 

stakeholder consultation report. 

• 

Indicate  which  groups  the  responses  came  from  and  how  representative  the 
responses were (for surveys). 

•  Reflect  as  to  whether the  input refers to facts,  estimates  or  opinions and their 

relevance for the specific questions. 

• 

Indicate limitations such as low number of responses, low quality of responses, 
or views of some stakeholder groups not being well-represented. 

Case studies 

•  Use a similar approach as for desk research presenting the relevant findings to 

the illustrate impacts in a specific context (e.g., country, product, issue) 

• 

Identify  the  limitations  (in  terms  of  scope,  ability  to  extract  more  general 
conclusions). 

Technical 
Workshops 
Focus groups 

/ 

• 

Indicate which types of stakeholders participated 

•  Report on the responses provided by stakeholder type 

• 

Indicate  which  groups  the  responses  came  from  and  how  representative  the 
responses were. 

•  Reflect the level of agreement among different categories of stakeholders 

Overall conclusions for impact assessment 

Synthesis 
evidence 

of 

•  Set out clear conclusions for the specific impacts drawing together the evidence 

presented from the different assessment methods 

•  Compare to what was anticipated in the baseline Reflect and  comment on the 
balance  and  strength  of  evidence  and  conclusions  (triangulation  or  cross-
checking of conclusions from alternative sources) 

Comment 
level 
certainty 
robustness 
conclusions 

on 
of 
and 
of 

•  Summarise the level of certainty of the conclusions based on the robustness of 

available evidence and taking into account the nature of the sources used. 

•  Be  clear  on  where  conclusions  are  stemming  from  the  stakeholder  input  and 
where they are stemming from the literature review. For example, conclusions 
based  predominantly  on  the  online  stakeholder  consultation  that  were  not 
possible to triangulate (or at least cross-check) with other sources will need to 
be considered as less robust than those based on analysis of data collected from 

108 

 
 
      
 
Element 

Approach 

validated datasets or peer reviewed studies. 

The analysis of problems followed the major steps advised in BR Guidelines Tool #14. For 
the Intervention logic, links between problem drivers and policy options were established. 

The  development  of  the  baseline  and  analysis  of  options,  including  the  development  of 
baseline,  was  based  on  the  principles  set  out  in  BR  Guidelines  Tool  #  17.  In  particular,  an 
initial  set  of  (sub)policy  options  were  screened  by  using  a  set  of  criteria  for  determining 
which options to include or not as advised in BR Guidelines Tool # 17.   

A description and, where possible, quantification of the economic, social and environmental 
impacts of the short-listed options was performed, following BR Guidelines Tool # 19. The 
main  direct  impacts  were  quantified  and  monetised  (for  both  the  baseline  and  the  policy 
options under consideration). Furthermore, indirect impacts were quantified, where possible, 
and  if  not  then  they  were  assessed  qualitatively  with  a  clear  indication  of  their  nature  and 
likely magnitude. Costs and benefits identified according to the standard typology of costs 
(e.g.,  administrative,  enforcement)  and  benefits  (BR  Guidelines  Tool  #58  and  #59).  The 
assessment was undertaken in line with the Better Regulation Guidelines and, in particular, 
Chapter 8 of the Toolbox (“Methods, models and costs and benefits”). 

Stakeholder consultation followed the advice outlined in BR Guidelines Tools # 53 – # 56. 
In  line  with  BR  Guidelines  Tool  #54,  questionnaire  surveys  were  used  to  allow  the 
stakeholders and the public to voice their opinions on the review of the Mercury Regulation. 
To  avoid  limitations  of a  questionnaire  survey  in  terms  of  the  focus  on  pre-defined  answer 
options, open questions and follow-up interviews were designed. Descriptive statistics and 
MS  Excel  were  used  for  the  analysis  of  quantitative  data.  Visual  aids  were  used  for  the 
presentation  of  quantitative  data.  For  interpreting  qualitative  data  thematic  analysis  was 
applied and supported by NVivo content analysis software. 

16.  2.  DATA RESOURCES AND ANALYTICAL SUPPORT 

Evidence utilised has been collected from literature (studies, reports, articles) to support the 
analyses in most of the tasks, especially in Tasks 1-5. 

  Review of the core sources for this report, such as the recent Commission Review 
Report1, the Assessment of the feasibility to phase-out dental amalgam2 as well as 
the Commission’s Inception Impact Assessment and associated feedback. 

  Carry out evidence mapping exercise to identify key needs and/or data gaps. 

1      Communication  from  the  Commission  on  the  review  of  the  Community  Strategy  Concerning  Mercury, 

COM(2010) 723 final, 7.12.2010. 
2     Deloitte and Woods study (2020) 

109 

 
 
      
 
 
 
                                                           
  Undertake  a  literature  review  through  systematic  web  searches,  coverage  of  a 
wide  range  of  stakeholders’  sources  and  considering  a  diverse  set  of  document 
types. 

  Screening  of  literature  to  determine  the  types  of  information  contained  and  the 

extent that the data is reliable and sound. 

The output of this process is the evidence base that underpins the impact assessment.  

17.  3.  CONSULTATIONS AND FIELD RESEARCH 

a. Open public consultation (OPC) 

The  online  OPC  offered  the  opportunity  for  interested  individuals  from  any  type  of 
stakeholder groups to give their opinion on the review of the Mercury Regulation. The OPC 
was launched on the Commission’s website3. 

b. Targeted stakeholder engagement: online survey 

To  gather  more  in-depth  information  from  those  stakeholders  already  possessing  a  good 
understanding  of  mercury  and  the  associated  problem  areas  addressed,  a  combination  of 
targeted stakeholder consultation methods was used. A targeted online survey was utilised to 
gather  the  views  of  key  groups  of  stakeholders,  including  Member  States’  authorities, 
industry  sector  (individual  companies  or  trade  associations)  or  other  types  of  organisations 
(e.g., environmental or civil society NGOs, research bodies, etc). 

c. Interviews 

telephone 

Targeted 
took  place  with 
representatives  of  regional  and  national  competent  authorities,  industry  associations,  civil 
society, and other key stakeholders.  

the  online  survey 

to  complement 

interviews 

d. Focus group 

A  focus  group  discussion  was  held  on  mercury-added  products  to  complement  the  online 
survey  and  interviews.  Representatives  of  industry  associations  and  the  NGO  community 
took part in the discussion. Attendance at the focus group was by invitation only. 

e. Stakeholder workshops 

Two workshops were held online. 

18.  4.  ROBUSTNESS OF THE EVIDENCE 

a. Consultations  

The level of credibility varies with regard to  each source of information  that has been used 
for  the  assessment.  In  principle,  sources  of  information  that  are  based  on  measured  or 
reported  information  are  believed  to  be  quite  certain.  However,  even  in  these  cases  the 

3 Mercury – review of EU law (europa.eu) 

110 

 
 
      
 
 
 
                                                           
robustness depends on the correct measuring and/or reporting of the parameter concerned. It 
is assumed that even if there are errors, these are not systematic. 

In other  cases, literature may draw itself on a lot of stakeholders opinion, or be based on a 
small sample or have other features that weaken its robustness. 

Literature which originates from stakeholders with a particular vested interest are treated with 
greater caution. Such literature may selectively present information or present it in a certain 
manner to support an argument that the interested party may wish to pursue. 

Stakeholder opinion presents similar risks to stakeholder-sourced literature. In their opinions, 
stakeholders may be seeking to manipulate the results to support their preferred outcome.  

In the case of this assessment, one dentist association holds opposite views to researchers and 
NGOs,  specifically  on  problem  1a  (phase-out  of  the  use  of  dental  amalgam).  In  general,  it 
opposes  a  short-term  phase-out  of  the  use  of  dental  amalgam,  pointing  to  the  potential  for 
problems in access to dental health care. Conversely, researchers and NGOs would like to see 
a complete phase-out of the use of dental amalgam in 2025. 

b. Analytical methods 

Dental amalgam 

Uncertainties of the estimate  

The quantification estimate bears some uncertainties, which are discussed below: 

The use of the DMFT index to quantify the amount of caries in the  European Union’s 
population: Indeed, this index is the Decayed, Missing, and filled Teeth index, meaning that 
not only filled teeth and teeth to treat are considered but also the missing teeth. This index is 
well correlated with the amount of treated caries for the population up until 40 to 50 years, 
when  teeth  removal  starts  to  increase  and  outweigh  cavity  treatment.  So,  the  model  is 
expected to overestimate the total use of mercury per year. 

Inconsistencies  in  historical  data:  The  historical  datasets  used  for  extrapolation  of  the 
estimates  are  poorly  collected.  Most  importantly,  the  time  of  recording  age  and  the  DMFT 
index is inconsistent. This reduces the power of forecasting. Moreover, we have extant data 
on DMFT per median age for every member state. Using the same to estimate a distribution 
across age intervals can lead to overestimation and/or high variance.  

The  model  does  not  consider  the  replacement  of failing filling  material:  Materials  used 
for  teeth  filling  when  treating  cavities  does  is  not  everlasting,  so  it  needs  sometimes  to  be 
replaced. The replacement was not considered due to too much uncertainty on the failure rate 
of the different materials as well as on the share of dental amalgam used to replace the failed 
materials. So, a small underestimation of the quantity of mercury used per year is expected. 

The  share  of  the  dental  amalgam  used  in  tooth  filling:  These  estimates  for  all  Member 
States come from the 2012 BioIS report, and no better values could be found. Unfortunately, 
it cannot be said what type of deviation can be expected from this source of uncertainty.  

The  assumption  under  which  the  improvement  of  dental  health  in  the  EU  follows  the 
same  trend  in  all  Member  States:  Indeed,  our  assumption  is  that  the  evolution  of  dental 
health in different MS can be compared to Germany (for which a lot of data was available). It 

111 

 
 
      
 
 
cannot be said what type of deviation from reality this model can cause, however, we expect 
it to be small.  

It is believed that the overestimation due to the use of the DMFT index will compensate the 
underestimation due to the unconsidered replacement of failed filling material. 

Emissions from crematoria 

Data gaps and uncertainties 

The  assessment  of  impacts  associated  with  measures  addressing  emissions  from  crematoria 
follows  the  same  quantitative  framework  as  used  to  establish  baseline  emissions.  The 
uncertainties  in  quantification  are  set  out  in  Annex  5.  These  include  uncertainties  and 
assumptions made in aspects including uptake of abatement technology across the EU in the 
baseline  scenario,  cremation  rates  across  different  Member  States,  and  the  use  of  dental 
amalgam  across  Europe.  In  quantifying  emissions  in  the  future  baseline  and  measure 
scenarios, projections of key parameters have been made based on historical data and there 
are uncertainties associated with such forecasting. 

Limited  information  could  be  obtained  through  the  literature  review  and  stakeholder 
consultation on the role of SMEs in the sector across Europe. It is assumed that SMEs will 
form at least part of the sector, especially in countries with a high number of small-capacity 
crematoria,  but  specific  information  upon  which  to  base  an  assessment  of  the  impacts  on 
SMEs  was  not  available.  Further  engagement  with  the  industry  through  Member  State 
surveys  could  provide  further  details  which  could  inform  a  judgement  on  the  impacts  to 
SMEs. 

Mercury-added products 

Data gaps and uncertainties 

For  the  estimation  of  impacts  of  policy  measures,  models  were  developed  that  allow 
quantitative statements on future export volumes, export values and mercury contents, at least 
for  fluorescent  lamps  for  general  lighting  purposes.  The  models  and  the  associated 
assumptions  and  model  parameters  are  described  in  the  Annex  5.  For  most  of  the  factors 
used, bandwidths describing the known or assumed uncertainties were  used. Many of these 
factors  and  ranges  were  discussed  with  stakeholders  or  derived  based  on  information  from 
stakeholders. Some factors are based on assumptions in the absence of concrete data. These 
factors  are  discussed  in  detail  and  the  range  used  is  explained.  Nevertheless,  it  cannot  be 
ruled out that individual factors will turn out differently in the actual future development. For 
example,  unforeseen  political  decisions  in  important  importing  countries  can  cause  a 
significant  drop  in  demand  that  exceeds  the  forecast  range.  Special  effects,  such  as  strong 
price increases for components, could make certain lamp types considerably more expensive 
and less attractive.  

A quantitative assessment was only possible for fluorescent lamps and, with restrictions, for 
dental  amalgam.  For  other  lamp  types  as  well  as  for  other  MAPs,  the  data  material  was 
missing.  Based  on  the  available  information,  however,  it  is  assumed  that  fluorescent  lamps 
have the highest export volume and dental amalgam the highest mercury content. These two 
products  are  thus  the  most  important  from  an  economic  and  environmental  point  of  view. 
When  a  quantitative  assessment  of  measures  appeared  too  uncertain,  either  a  qualitative 
assessment was made, or the magnitude of an effect was estimated.  

112 

 
 
      
 
Annex 5: Detailed Baseline  

The baseline option represents  a ‘no policy  change’ scenario. That  is,  the baseline  assumes 
that the current EU-level and national policies and measures continue to be in force and that 
the sectors are affected by baseline expectations. 

1.  Baseline for dental amalgam 

To develop a baseline for the mercury used in the EU due to the use of dental amalgam as a 
tooth filling material, an epidemiologic approach was used. A German study1 used data from 
national  dental  health  studies,  which  showed  good  correlation  and  predictive  capacity  for 
DMFT  in  the  country  using  the  DMFT  for  different  age  groups2  and  specific  years  (2000, 
2005,  2015,  and  2030).  A  similar  approach  has  been  applied  in  this  assessment  using  the 
German data to create a model approximating the DMFT for Germans at different ages and 
dates of birth to a good degree.  

The  approach  uses  non-linear  estimation  methods  to  calculate  a  close  estimate  of  total 
mercury  in  dental  patients  on  an  average  across  EU  Member.  There  are  primarily  three 
reasons for the application of this method: 

1.  The DMFT index and age groups in the baseline data show a clear non-linear trend. 
The  share  of  people  that  require  dental  care  (sorted  by  mean  age)  spikes  during 
adolescence and puberty. There is a relative fall and stabilisation of this share during 
working age while spiking again during retirement years. A 3rd-degree polynomial fit 
for the data is hypothesised. 

2.  The  baseline  raw  data  has  been  poorly  maintained,  with  inconsistency  in  DMFT 
recorded  for  each  age  and  the  time  of  recording.  German  data  was  found  to  be  the 
most consistent among the EU Member States.  

3.  For  the  German  dataset,  age  has  not  been  recorded  as  a  discrete  variable  but  as  a 
categorical  interval  (“6-9  years  old”,  “10-19  years  old”,  etc.).  Therefore,  standard 
Ordinary Least Squares (OLS) methods may be inconsistent3. Even if the age intervals 
may  record  frequencies  to  be  later  used  as  weights,  the  inconsistency  of  data 
recording makes robust estimation a big challenge.  

Since  the  German  data  was  used  as  a  baseline  for  estimation  across  the  other  EU  Member 
States, consideration needs to be given to the interval nature of age groups. Using midpoints 
for each interval for OLS estimation does not take into account the distribution of frequencies 
assigned to each interval. Hence, we cannot substitute the midpoint as a proxy for mean age 
in each interval. Moreover, there are some statistical concerns with this form of estimation – 
the errors of predictions (and standard deviation) for each age interval can be non-constant. 
Since  OLS  assumes  constant  variance  of  error  terms,  a  significant  scatter  in  standard 
deviation values (or heteroscedasticity) can have the following issues: 

1  Jordan,  Rainer  A.  et  al.  "Trends  In  Caries  Experience  In  The  Permanent  Dentition  In  Germany  1997–2014, 
And  Projection  To  2030:  Morbidity  Shifts  In  An  Aging  Society".  Scientific  Reports,  vol  9,  no.  1,  2019.   
Springer Science And Business Media LLC, doi:10.1038/s41598-019-41207-z. Accessed 4 Mar 2022. 

2  6-9, 10-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, 80-89, ≥90 year-olds 
3  Caudill,  Steven  B.,  and  John  D.  Jackson.  “Heteroscedasticity  and  Grouped  Data  Regression.”  Southern 

Economic Journal 60, no. 1 (1993): 128–35. https://doi.org/10.2307/1059937. 

113 

 
 
      
 
                                                           
 
  The  point  estimates  are  unbiased,  meaning  they  converge  to  the  true  estimate  over 
large  samples.  However,  they  are  inconsistent  i.e.,  they  do  not  have  a  minimised 
variance out of all other unbiased point estimates. 

  Statistical tests to prove the significance of the point estimates are invalidated as they 

assume a constant variance of error terms across all observations. 

Since  the  German  data  for  the  baseline  includes  a  categorical  variable,  an  approach  to  the 
estimation  is  made  via  choice  models.  As  the  categories,  i.e.,  age  intervals,  are  ordered,  an 
ordered logistic regression was used to build the model. 

Considering the following estimation: 

𝐴𝑔𝑒 ∗= 𝛽𝐷𝑀𝐹𝑇𝑡,𝑖 + 𝜎𝜖𝑡,𝑖 

Where β is the point estimate for the regression coefficient, and ε is the error residual in time,  

t∈{2000,  2005,  2015,  2030},  and  observation  (i).  We  assume  a  symmetric  and  cumulative 
probability density function for the error term, F(.). The error terms are normalised with their 
standard  deviation,  𝜎.  Age*  is  a  latent  variable  as  we  cannot  observe  the  exact  age  given 
some  DMFT.  Hence,  we  introduce  cut  off  points  to  observe  this  variable.  This  is  done  to 
accommodate the categorical nature of the dependent variable. 

Observing category j for Age, 

Agei = 𝑗 

𝑖𝑓𝑓 𝐴𝑗−1 < Agei

* < 𝐴𝑗 

For  cut  off points  A  at  each  category  j.  For estimation  purposes, we  find the probability of 
observing a  certain  age  category  as  a proxy for  the share of people that  require dental care 
given a non-zero DMFT. 

Pr{𝐴𝑔𝑒𝑖 = 𝑗} = Pr{𝐴𝑗−1 < 𝐴𝑔𝑒∗ < 𝐴𝑗} 
𝐴𝑗−1 − 𝛽𝐷𝑀𝐹𝑇𝑡,𝑖
𝜎

} < 𝜖  < Pr {

𝐴𝑗 − 𝛽𝐷𝑀𝐹𝑇𝑡,𝑖
𝜎

⟺   Pr {

} 

⇔ 𝐹 [

𝐴𝑗−1 − 𝛽𝐷𝑀𝐹 𝑇𝑡,𝑖
𝜎

] − 𝐹 [

𝐴𝑗 − 𝛽𝐷𝑀𝐹𝑇𝑡,𝑖
𝜎

]   

Where F[.] is the cumulative density function of the error terms.  

To  find  the  optimum  point  estimates,  we  use  maximum  likelihood  estimation.  The  log-
likelihood function of the exercise above is given by finding the joint density of the observed 
data and taking the natural log for computational simplicity. 

10

10
ln(𝐿)   = ∑ ∑ 𝚤{𝑖 = 𝑗} ln {𝐹 [
𝑗=1

𝑖=1

𝐴𝑗−1 − 𝛽𝐷𝑀𝐹 𝑇𝑡,𝑖
𝜎

] − 𝐹 [

𝐴𝑗 − 𝛽𝐷𝑀𝐹𝑇𝑡,𝑖
𝜎

]}

Over 10 observations, i, and 10 age intervals, j. 1{i=j} is an indicator function that returns a 
value of 1 when observation i belongs to category j.  

For identification of the point estimates,  we introduce 9 cut  off points  A. Hence, we obtain 
estimates  with  reference  to  one  age  category.  We  also  assume  a  parallel  regression 
assumption,  i.e.,  the  point  estimates  are  constant  along  all  thresholds.  Also,  we  take  the 
logistic function as the cumulative density for the error terms. 

114 

 
 
      
 
 
The  ordered  logistic  regression  is  used  to  calculate  expected  probabilities  for  each  age 
interval  at  the mean level  of DMFT. Using collected data on  each Member State’s  average 
DMFT  at  median  age,  we  find  the  expected  probability  of  being  in  the  corresponding  age 
group.  This  extrapolation  is  supplemented  through  a  linear  trend  of  expected  probabilities 
where the  year 2000 is  taken as the base (t=00). The probabilities extrapolated thus  far are 
used to estimate the share of the population sorted by age that requires dental care, the total 
amount of dental operations, and the absolute share of amalgam in said  operations. Finally, 
we estimated the average mercury content in patients and wasted away from the calculations 
above. 

Ordinal logistic regressions for the German data over four years (2000, 2005, 2015, 2030) are 
summarised in the following table. 
Table 1: Ordinal regressions for the German Data 

Odds Ratio for 
Age Categories 

Point Estimate 
of DMFT 

Year 2000 

Year 2005 

Year 2015 

Year 2030 

1.43438 

(0.1493) 

1.5184 

(0.1655) 

1.6968 

(0.1975) 

1.9457 

(0.239) 

t = 2.417* 

t = 2.524* 

t = 2.678** 

t = 2.785** 

Note: Cut off points for age categories omitted for brevity 
Brackets denote standard errors 
*Significant at 95% Confidence 
**Significant at 99% Confidence 

The point estimate reports the odds of a dental patient moving from a younger age group to a 
higher  one.  The  regression  model  predicts  that  as  the  DMFT  score  rises  by  one  unit,  the 
patient is 43% more likely to be older than 10-19 years old (the reference category) in 2000. 
The  odds  over  the  years  have  risen  to  the  point  that  the  2030  projection  predicts  that  the 
patient’s chance of being older nearly doubles. A case in point to explain this trend can be a 
rise  in  dental  health  and  demographic  change  wherein  the  median  age  of  dental  patients  is 
moving away from younger populations.  
Figure 1: Predicted Probabilities for each Age Interval, Germany 2000 

115 

 
 
      
 
 
 
 
 
 
Figure 2: Predicted Probabilities for each Age Interval, Germany 2005 

Figure 3: Predicted Probabilities for each Age Interval, Germany 2015 

Figure 4: Predicted Probabilities for each Age Interval, Germany 2030 

The predicted probabilities above are used to forecast expected population shares for all other 
Member States. We assume a third-degree polynomial forecast. Having well characterised the 
German case, other Member States can be compared to it and will either experience a “delay” 
when compared to it or a “head start”. To perform this comparison, the DMFT index for all 
Member States at different ages for a given year was compared to that of Germany. The aim 
was to determine in which year in Germany could the same DMFT and age combination be 
observed. Once this was determined, the delay or head start was determined e.g., for Austria, 

116 

 
 
      
 
 
 
 
 
the DMFT of 40-year-olds in 2000 was 14.7 meaning that in Germany, this set of conditions 
was  met  in  1996.  Thus, Austria  has  a  4-year  delay  when  comparing  its  population’s  dental 
health with that of Germany. This same calculation was done for all Member States, and the 
corresponding data is available in Table 2 below.  

Table  2:  DMFT  at  specific  ages  and  year  for  all  Member  States  and  year  at  which  the  same 
conditions were met in Germany for 2019 

DMFT 

Age  Year 

in 

Member 
State 

Corresponding 
year  with  German 
model 

Year  equivalent  to 
for  model 
2019 
(corresponding  year 
+ 2019 – year)  

Dental  health 
or 
“delay” 
“head start” 

Austria 

Belgium 

Bulgaria 

Croatia 

Cyprus 

Czech 
Republic 

Denmark 

Estonia 

Finland 

France 

Germany 

Greece 

Hungary 

Ireland 

Italy 

Latvia 

Lithuania 

Luxemburg 

Malta 

Netherlands 

Poland 

Portugal 

Romania 

Slovakia 

Slovenia 

Spain 

Sweden 

14.7 

10.3 

12.1 

3.5 

2 

17.1 

13.5 

6.75 

0.9 

14.6 

1.95 

15.4 

15.4 

26.3 

18.5 

17.3 

3 

1.4 

17.4 

19.2 

10.4 

6.9 

4.1 

19 

7.4 

0.7 

40 

40 

35 

12 

15 

40 

40 

17 

12 

40 

12 

40 

40 

70 

40 

40 

12 

12 

40 

40 

40 

18 

12 

40 

40 

12 

2000 

2008 

2006 

1999 

2010 

2006 

2008 

1993 

2010 

1994 

2022 

2011 

2003 

1990 

1993 

1993 

1997 

1990 

2003 

1986 

1997 

2013 

1995 

2005 

1993 

2020 

2017 

1996 

2011 

1998 

1981 

2013 

1990 

2000 

1984 

2016 

1997 

2022 

1999 

1995 

1995 

1987 

1987 

1990 

1986 

2007 

1989 

1985 

2010 

1987 

1996 

1986 

2024 

2021 

117 

2015 

2022 

2011 

2001 

2022 

2003 

2011 

2010 

2025 

2022 

2019 

2007 

2011 

2024 

2013 

2013 

2012 

2015 

2023 

2022 

2007 

2016 

2011 

2010 

2012 

2023 

2023 

-4 

3 

-8 

-18 

3 

-16 

-8 

-9 

6 

3 

0 

-12 

-8 

5 

-6 

-6 

-7 

-4 

4 

3 

-12 

-3 

-8 

-9 

-7 

4 

4 

 
 
      
 
  
 
 
Thanks  to  this  model,  the  baseline  for  the  state  of  dental  health  in  the  EU  in  2019  was 
calculated  and  expected  population  given  a  DMFT  for  all  ages  for  all  Member  States  was 
determined.  These  values  were  then  used  together  with  the  share  that  dental  amalgam 
represents  in  the fillings used for  restorations  in  all Member States, the  mercury  content of 
dental  amalgam  capsules  and  the  share  of  said  capsules  fitted  in  the  tooth  to  calculate  the 
amount of mercury used in the EU every year.  

To estimate the quantity of mercury used for the treatment of dental cavities, three datasets 
are crucial: 

1.  The mercury content of the dental amalgam capsules used by dentists,  

2.  The share of dental amalgam used in the treatment of caries in the different MS, and 

3.  The share of the dental amalgam capsule put in the tooth.  

Mercury content of dental amalgam capsules  

It was identified for different types of capsules namely  

  Pre-dosed amalgam capsules permite, logic+ and gs-804 

  MegalloyⓇ EZ5 

  Septalloy NG 70, Securalloy6 

  DispersalloyⓇ7 

Using  the  mercury  content  of  the  medium  size  capsules,  the  mercury  content  of  dental 
amalgam  capsules  was  approximated  to  range  between  480  mg  and  700  mg  (data  was 
available for capsules ranging from small to large sizes, the choice was made to use the data 
for the medium-sized capsules to have a narrower range of mercury content since medium-
sized capsules are expected to be the most used).  

Share of dental amalgam use  

Share of dental amalgam use was approximated using data from the different sources. Where 
more  recent  data  was  available  it  was  used,  else  the  data  from  previous  sources  were  used 
such as BioIS (2012), Deloitte (2020) or the final Staff Working Document 2016/017 (which 
also relied on BioIS (2012)8.  

The share of dental amalgam use (minimum and maximum) per country is presented in Table 
3  below,  along  with  the  data  source  and  whether  the  data  is  estimated  or  reported.  It  also 
indicates  which  Member  States  have  (known)  phase-out  plans,  by  when  and  the  phase-out 
objective.

4 Sdi.Com.Au, 2022, https://www.sdi.com.au/pdfs/instructions/pt-br/gs-80_sdi_instructions_pt-br.pdf. Accessed 

29 Mar 2022. 

5 Accessed March 29, 2022, from : Mode d`emploi - DSM dentaire | Manualzz 
6 Uploads-Ssl.Webflow.Com, 2022, https://uploads-

ssl.webflow.com/571024186d8e1cce4121d731/5be974bc16344085fcc0f4d6_S%2005%2086%20050%2005%
2000_6amalgam-SP.pdf. Accessed 29 Mar 2022. 

7 Dentsplyestore.Com.Au, 2022, 

http://www.dentsplyestore.com.au/www/770/files/dispersalloy_capsules_dfu.pdf. Accessed 29 Mar 2022. 

8 SWD/2016/017 final 

118 

 
 
      
 
                                                           
Table 3: Dental amalgam data for all Member States 

Amalgam use % 

Method 

Ref. year 

Phase-out 
plan 

Goal 

Comment 

Min. 

Mean 

Max. 

Austria 

Belgium 

Bulgaria 

Croatia 

Cyprus 

Czechia 

Denmark 

Estonia 

Finland 

France 

35% 

7% 

6% 

35% 

6% 

35% 

1.7% 

1% 

1% 

20% 

Germany 

Greece 

Hungary 

Ireland 

5% 

35% 

5% 

20% 

43% 

7% 

21% 

43% 

21% 

43% 

1.7% 

2.5% 

1% 

25% 

6% 

43% 

7% 

20% 

estimated 

reported 

estimated 

estimated 

estimated 

estimated 

reported 

estimated 

reported 

reported 

reported 

estimated 

reported 

reported 

2010 

2018 

2010 

2010 

2010 

2016 

2017 

2010 

2019 

2021 

2018 

2010 

2018 

2018 

50% 

7% 

35% 

50% 

35% 

50% 

1.7% 

5% 

1% 

30% 

7% 

50% 

9% 

20% 

119 

2025 

2025? 

2030 

1% 

IGU(1) 

under 
consideration 

2030 

2030 

2030 

Reimbursement 
scheme 
2021 
100% 
Alternative, 
assumption: 
50% reduction 

1% 

IGU <1% 

 
 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amalgam use % 

Method 

Ref. year 

Phase-out 
plan 

Goal 

Comment 

Italy 

Latvia 

1% 

6% 

Lithuania 

4.6% 

Luxembourg  6% 

Malta 

35% 

Netherlands 

0.5% 

Poland 

35% 

Portugal 

Romania 

Slovakia 

Slovenia 

Spain 

Sweden 

5% 

7.5% 

40% 

70% 

1% 

0% 

Min. 

Mean 

Max. 

2.5% 

5% 

estimated 

2010 

2025 

21% 

4.6% 

21% 

43% 

0.5% 

43% 

10% 

7.5% 

50% 

70% 

1% 

0% 

35% 

4.6% 

35% 

50% 

0.5% 

50% 

15% 

7.5% 

60% 

70% 

1% 

0% 

estimated 

reported 

estimated 

estimated 

reported 

estimated 

reported 

reported 

reported 

reported 

reported 

reported 

2010 

2019 

2010 

2010 

2018 

2010 

2025 

2018 

2010 

2019 

2019 

2009 

2022 

2031 

2030 

2030 

2020 

IT  NAP:  end  of 
2014(2) 

in  public, 

0% 
but private? 

IGU 

(1)  IGU https://www.ig-umwelt-zahnmedizin.de/aktuelles/update-nationale-aktionsplaene-zum-ausstieg-aus-der-verwendung-von-amalgam-in-der-eu/ 
(2)  IT NAP 

 Trova Norme & Concorsi - Normativa Sanitaria (salute.gov.it) 

120 

 
 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Share of the dental amalgam capsule actually put in the tooth 

Only one number could be found regarding the share of dental amalgam capsule content 
to  66%
put 

to  range  from  26%  up 

It  was  estimated 

in  patients’ 

teeth. 

1 , which would represent a range of 125 mg, up to 462 mg of mercury put in patients’ 
teeth per capsule used.  

Quantification of Mercury in the EU due to dental amalgam use 

Using the above information in combination with the population data from Eurostat for 
2019 with projections to 2030 and the DMFT estimates for all MS for 2019 and 2030, it 
was possible to estimate the quantities of mercury used in the EU due to dental amalgam 
use in 2019 and 2030 using the following formula: 

𝑛

∑(

𝑖=1

𝐷𝑀𝐹𝑇𝑛
𝑛

) ∗ 𝑃𝑜𝑝𝑛 ∗ 𝐷𝐴% ∗ 𝐻𝑔 ∗ 𝐷𝐴𝑡𝑜𝑜𝑡ℎ

Where: 

a)  n is the age of the population group 

b)  DMFTn is the DMFT index at age n 

c)  Popn is the population number at age n 

d)  DA% is the share of dental amalgam use  

e)  Hg is the mercury content of dental amalgam capsules 

f)  DAtooth Is the share of the dental amalgam capsule actually put in the tooth.  

The mean total mercury used in dental amalgam in the EU and its fate is displayed in the 
Figure 5 below.  

1  Drummond,  James  L.  et  al.  "Mercury  Generation  Potential  from  Dental  Waste  Amalgam".  Journal  Of 
Dentistry, vol 31, no. 7, 2003, pp. 493-501. Elsevier BV, doi:10.1016/s0300-5712(03)00083-6. Accessed 
29 Mar 2022. 

121 

 
 
 
                                                           
Figure  5:  Baseline  mercury  consumption  in  the  EU  Member  States  in  the  form  of  dental 
amalgam in 2019, 2025 and 2030 (tonnes) 

The mean total mercury used in the EU for dental amalgam use is estimated to be  40.4 
tonnes  (18.6  tonnes  in  teeth  and  21.8  tonnes  wasted)  in  2019  (with  the  lower  estimate 
being 31.6 tonnes and the upper estimate 50.3 tonnes). In 2030, mercury use is expected 
to  decrease  to  11.2  tonnes  (with  the  lower  estimate  being  7.2  tonnes  and  the  upper 
estimate  being  16.8  tonnes).  The  lower  and  upper  estimates  were  calculated  using  the 
extreme  values  for  the  three  parameters  discussed  earlier.  The  values  used  for  the 
different  estimates  are  listed  in  Table  4  (except  the  share  of  dental  amalgam  use  per 
Member State displayed in Table 3). 

The  previous  study  estimated  the  total  dental  amalgam  use  in  the  EU  in  2018  between 
26.9 tonnes and 58.3 tonnes. Our estimate range is slightly different; several factors may 
explain this: 

  This  study’s  estimate  is  for  the  EU27,  whereas  the  previous  one  considered  the 

EU28.  

  This study uses a total mercury content of amalgam capsules of ~590 ± 110 mg, 

whereas the previous study used a mercury content per capsule of 850 mg.  

  This study based the calculation of dental amalgam use on the DMFT index and 
an  extrapolation  model  based  on  an  epidemiologic  approach,  whereas  the 
previous study used population data to fill in data gaps related to the  number of 
treatments  (assuming  the  same  number  of  procedures  per  person  but  using  a 
different  population  total  for  different  countries  which  does  not  consider  the 
varying status of dental health in different Member States).  

Table  4:  Values  of  the  parameters  used  for  the  lower,  mean  and  upper  values  of  the 
estimate of dental amalgam use in 2019 

Parameter 

Lower estimate 

Mean estimate 

Upper estimate 

122 

 
 
 
Parameter 

Lower estimate 

Mean estimate 

Upper estimate 

Mercury content in 
dental amalgam 
capsule (mg) 

Share of dental 
amalgam capsule put 
in the tooth (%) 

474 

26 

587 

46 

701 

66 

Figure 6 demonstrates the number of dentists per 100,000 inhabitants for each Member 
State  as  per  the  latest  date  of  data  collection.  It  illustrates  that  Greece  has  the  highest 
density  of  dentists,  with  around  126  dentists  per  100,000  inhabitants.  Furthermore,  it 
illustrates  that  Poland  has  the  lowest  density  of  dentists,  with  around  35  dentists  per 
100,000 inhabitants.  

Figure 6: Number of dentists per 100,000 inhabitants in Member States 

Table 5: Number of dentists and access to dentists across Member States 

Member 
State 

Number 
of 
dentists 
for 
latest 
year  of 
data 

Latest 
year 
of 
data 

Number of dentists per 100,000 population 

2012  2013  2014  2015 

2016 

2017 

2018 

2019 

2020 

2021 

AT 

5,206 

2020  56.9 

57 

57.25  57 

56.7 

57 

56.86  58 

58.38  ND 

123 

 
 
 
 
 
Member 
State 

Number 
of 
dentists 
for 
latest 
year  of 
data 

Latest 
year 
of 
data 

Number of dentists per 100,000 population 

2012  2013  2014  2015 

2016 

2017 

2018 

2019 

2020 

2021 

BE 

BG 

CY 

CZ 

DE 

DK 

EE 

EL 

ES 

FI 

FR 

HR 

HU 

IE 

IT 

LT 

LV 

LU 

8,871 

2020  70.85  71.37  72.33  73.54  74.82  74.86  75.38  75.7 

76.84  ND 

7,373 

2020  94.92  97.23  99.56  100.26  104 

106.06  103.66  106.64  106.33  ND 

1,001 

2019  94.45  96.18  98.42  103.34  103.57  109.25  112.18  113.5  ND 

ND 

7,914 

2020  70.98  70.63  75.11  ND 

75.29  74.77  73.79  73.32  73.98  ND 

71,108 

2020  84.42  84.84  85.57  85.75  85.58  85.65  85.78  85.5 

85.51  ND 

4,190 

2019  79.67  78.27  77.01  76.06  74.18  71.83  71.84  72.06  ND 

ND 

1,336 

2020  90.42  90.29  92.98  94.19  95.53  96.02  96.6 

98.2 

100.49  ND 

13,464 

2019  131.8  129.5  128.5  124.8  124.5  125.5  125.4  ND 

ND 

ND 

1,303 

2019  90.4 

90.2  92.9  94.2 

95.5 

95.9 

96.5 

ND 

ND 

ND 

3,954 

2018  73.64  71.98  72.87  73.05  72.68  71.77  71.69  ND 

ND 

ND 

42,844 

2020  61.8 

62.06  61.69  61.97  62.44  62.37  63.36  63.29  63.59  ND 

3,526 

2020  75.5 

75.8  78.54  79.54  80.07  83.13  84.82  87.01  87.12  ND 

6,578 

2020  56.54  60.27  62.87  60.31  61.98  67.32  70.28  73.12  67.47  ND 

1,303 

2020  57.7 

57.4  59.6  60.8 

62.8 

65.5 

66.8 

68.5 

ND 

ND 

50,993 

2021  ND 

78.09  78.32  78.39  80.09  81.85  83.63  86.98  86.93  86.05 

3,100 

2020  89/87  90.54  91.02  91.02  97.17  100.37  103.23  105.44  110.92  ND 

1,362 

2020  71.03  72.49  70.22  71.76  72.01  71.05  70.62  71.27  71.67  ND 

581 

2017  83.06  84.66  85.56  88.83  94.27  97.43  ND 

ND 

ND 

ND 

MT 

269 

2020  45.24  46.25  46.25  46.29  47 

47.65  47.87  50.19  52.2 

ND 

NL 

PL 

PT 

9,879 

2020  49.48  49.48  48.87  51.54  51.11  55.07  55.58  56.51  56.64  ND 

13,331 

2017  32.82  32.39  34.43  33.18  35.05  35.1 

ND 

ND 

ND 

ND 

10,896 

2018  80.4 

84.7  87.6  91.3 

95.6 

101.2  ND 

ND 

ND 

ND 

RO 

18,298 

2020  68.1 

71.3  74.57  77.66  82.66  79.11  83.51  86.8 

95.02  ND 

124 

 
 
Member 
State 

Number 
of 
dentists 
for 
latest 
year  of 
data 

Latest 
year 
of 
data 

Number of dentists per 100,000 population 

2012  2013  2014  2015 

2016 

2017 

2018 

2019 

2020 

2021 

SE 

SI 

SK 

8,003 

2019  82.06  81.72  81.52  81.69  81.5 

81.36  80.76  77.86  ND 

ND 

1,570 

2019  63 

64.9  66.2  67.46  68,81  70.41  71.94  72.5 

74.68  ND 

2,852 

2019  49.2 

47.7  48.7  48.7 

49.6 

50 

51 

ND 

ND 

ND 

ND = No data 

Data  expressed  as  total  number  of  dentists  and  number  of  dentists  per  100,000  inhabitants  obtained  from  Eurostat 
available here. With the exception of Greece, Estonia, Ireland, Portugal and Slovakia where data was obtained from the 
World Health Organisation available here and here. 

Uncertainties of the estimate  

The quantification estimate bears some uncertainties, which are discussed below: 

  The use of the DMFT index to quantify the amount of caries in the European 
Union’s population: The DMFT does not only consider filled teeth and teeth to 
be treated but also missing teeth. This index is well correlated with the amount of 
treated caries for the population up until 40 to 50 years, at which point when teeth 
removal  starts  to  increase  and  outweigh  cavity  treatment.  So,  the  model  is 
expected to overestimate the total use of mercury per year. 

  Inconsistencies in historical data: The historical datasets used for extrapolation 
of the estimates are poorly collected. Most importantly, the time of recording age 
and  the  DMFT  index  is  inconsistent.  This  reduces  the  power  of  forecasting. 
Moreover,  we  have  extant  data  on  DMFT  per  median  age  for  every  Member 
State.  Using  the  same  to  estimate  a  distribution across  age  intervals  can  lead  to 
overestimation and/or high variance.  

  The  model  does  not  consider  the  replacement  of  failing  filling  material: 
Materials  used  for  teeth  filling  when  treating  cavities  is  not  everlasting,  so  it 
needs to be replaced sometimes. The replacement was not considered due to too 
much  uncertainty  on  the  failure  rate  of  the  different  materials  as  well  as  on  the 
share  of  dental  amalgam  used  to  replace  the  failed  materials.  So,  a  small 
underestimation of the quantity of mercury used per year is expected. 

  The share of the dental amalgam used in tooth filling: These estimates for all 
Member States come from the 2012 BioIS report, and no better values could be 
found.  Unfortunately,  it  cannot  be  said  what  type  of  deviation  can  be  expected 
from this source of uncertainty.  

  The  assumption  under  which  the  improvement  of  dental  health  in  the  EU 
follows  the  same  trend  in  all  Member  States:  The  assumption  is  that  the 
evolution  of  dental  health  in  different  Member  States  can  be  compared  to 

125 

 
 
Germany (for which a lot of data was available). It cannot be said  what  type of 
deviation from reality this model can cause, however, we expect it to be small.  

It is believed that the overestimation due to the use of the DMFT index will compensate 
the underestimation due to the unconsidered replacement of failed filling material. 

2.  Baseline for emissions from crematoria 

At  present,  there  is  no  EU-level  legislation  requiring  Member  States  to  install  mercury 
abatement  systems  in  crematoria.  The  OSPAR  Commission  adopted  its  non-binding 
Recommendation 2003/4, which states that “Contracting Parties should ensure that the 
operators of crematoria apply BAT at their crematoria to prevent the dispersal into the 
environment  of  mercury  from  human  remains,  especially  from  dental  amalgam”.  The 
Recommendation  also  identifies  a  number  of  abatement  options  including  co-flow 
filtration, solid-bed filtration, and gas scrubbing.  

Similarly, the Baltic Marine Environment Protection Commission (Helsinki Commission 
–  HELCOM)  adopted  Recommendation  29/1  in  2008,  which  recommends  that 
governments  of  the  Contracting  Parties  implement  measures  to  ensure  that  crematoria 
operators with a capacity exceeding 500 cremations/year implement BAT to comply with 
an emissions limit value of 0.1 mg/Nm3. Recommendation 29/1 also identifies the same 
techniques  set  out  in  OSPAR  Recommendation  2003/4  as  potential  BAT.  Parties  to 
OSPAR and/or HELCOM within the EU are highlighted in Figure 6. 

Figure 7: Members of OSPAR and/or HELCOM 

126 

 
 
 
 
National-level  legislation  addressing  mercury  emissions  from  crematoria  is  varied. 
Information on national regulatory approaches gained through the stakeholder survey and 
literature review is set out in Table 6 below. 

Table 6: National-level regulation of crematoria mercury emissions (based on information 
fathered to date) 

Member 
State 

Regulation of crematoria mercury emissions 

AT 

BE 

BG 
CY 
CZ 
DE 

DK 

EE 
EL 
ES 
FI 
FR 

HR 
HU 
IE 

IT 

No  regulation  identified,  although  some  sources  indicate  an  emissions  limit 
value (ELV) of 0.1 mg/Nm3 applies1. 
ELVs  of  0.2 mg/Nm3  and  0.1 mg/Nm3  in  effect  in  Flanders  and  Brussels, 
respectively2. 
No regulation identified. 
No regulation identified. 
No regulation identified. 
No legislation, but Germany has adopted guidance on  BAT in human cremation 
installations,  which  indicates  that  when  dust  filters  and/or  sorbents  are  utilised, 
typical  mercury  emissions  range  between  0.0001  and  0.05  mg/m3  (fixed  bed  or 
sorbent injection). 
Legislation BEK nr 2079 af 15/11/20213 sets a mercury ELV of 0.1 mg/Nm3 (dry 
gas) for crematoria with an annual capacity of over 400 cremations. Flue gas must 
be tested once yearly for mercury. 
No regulation identified. 
No regulation identified. 
No regulation identified. 
No regulation identified. 
The  Arrêté  du  28  janvier  2010  relatif  à  la  hauteur  de  la  cheminée  des 
crématoriums  et  aux  quantités  maximales  de  polluants  contenus  dans  les  gaz 
rejetés à l'atmosphère4 sets an ELV of 0.2 mg/Nm3. 
Regulation NN 87/20175 establishes an ELV of 0.05 mg/Nm3. 
No regulation identified. 
No national-level regulation in place. Crematoria emissions are regulated locally 
through  the  permitting  system,  where  ELVs  are  specified  on  an  installation-by-
installation basis. 
No  national  regulation  in  effect.  Regional  rules  generally  establish  an  hourly 
average emission limit value of 0.05 mg/Nm3. 

1   Eurocrematoria (2008) Cremation and respect for the environment. 

https://www.funeralnatural.net/sites/default/files/articulo/archivo/ecn_manifesto_definitive.pdf 

2  Deloitte, Ineris, Wood (2020), Assessment of the feasibility of phasing-out dental amalgam – Final report 
3   Retsinformation (2021). BEK nr 2079 af 15/11/2021. https://www.retsinformation.dk/eli/lta/2021/2079 
4   Légifrance (2010) Arrêté du 28 janvier 2010 relatif à la hauteur de la cheminée des crématoriums et aux 
l'atmosphère. 

quantités  maximales 
les 
https://www.legifrance.gouv.fr/loda/id/JORFTEXT000021837100/ 

polluants 

contenus 

rejetés 

dans 

gaz 

de 

à 

5    Narodne  Novine  (2017)  Uredba  o  graničnim  vrijednostima  emisija  onečišćujućih  tvari  u  zrak  iz 

nepokretnih izvora. https://narodne-novine.nn.hr/clanci/sluzbeni/2017_08_87_2073.html 

127 

 
 
                                                           
LT 
LU 
LV 
MT 
NL 

PL 
PT 
RO 
SE 

SI 
SK 

Order No. D1-3576 sets an ELV of 0.1 mg/Nm3. 
No regulation identified. 
No regulation identified. 
No regulation identified. 
Article 4.119 of the Environmental Management Activities Decree7 sets an ELV 
of 0.05 mg/Nm3. 
No regulation identified. 
No regulation identified. 
No regulation identified. 
All  crematoria  require  environmental  permits,  either  from  national  or  local 
authorities  depending  on  operating  capacity.  Permits  specify  best  practices  and 
BAT. 
No regulation identified. 
No regulation identified. 

The  Commission’s  Article  19(1)  review  report  estimated  that  mercury  emissions  from 
crematoria totalled 1.6 tonnes in 2018 in the EU; the basis for this estimate is not clear. 
Data officially submitted by EU27 Member States as part of their reporting requirements 
under  the  CLRTAP  indicate  that  emissions  totalled  0.9 tonnes  in  20198.  These  figures 
have  been  derived  following  methodologies  specific  to  crematoria  emissions  set  out  in 
the  EMEP/EEA  air  pollutant  emission  inventory  guidebook9.  The  guidebook  sets  out  a 
‘Tier  1’  methodology  as  the  default  approach  to  quantifying  crematoria  emissions;  this 
involves  applying  emission  factors  to  activity  data  (number  of  bodies  cremated).  The 
recommended  emission  factor  for  mercury  emissions,  1.49 grams  per  cremated 
body (95% CI 0.149 – 14.9 g/body), is based on sources from 1992, and is an average 
factor  covering  different  abatement  technologies.  While  the  guidebook  highlights  that 
more detailed information should be used where available, it does not specifically set out 
any  more  detailed  ‘Tier  2’  and  ‘Tier  3’  methodologies  for  quantifying  emissions  from 
human cremation. It is therefore likely that the emissions inventory data reported under 
the  CLRTAP  are  largely  derived  using  a  top-down  approach  based  on  the  broadly 
averaged  EMEP/EEA  emission  factors,  and  there  is  significant  uncertainty  in  the 
estimated total emissions across the EU27. 

As part of the Impact Assessment, information was gathered for each EU Member State 
on  the  number  of  cremations  (derived  using  mortality  statistics  and  reported  cremation 
rates),  as  well  as  the  number  of  crematoria  operating  in  the  country.  Additionally, 
information  on  the  split  of  crematoria  by  capacity  band  was  collated  from  publicly 

6      Valstybės  žinios  (2008).  Dėl  Aplinkosaugos  reikalavimų  kremavimo  įmonėms  aprašo  patvirtinimo. 

https://www.e-tar.lt/portal/legalAct.html?documentId=TAR.09B74C209D3A 

7      Overheid.nl  (2022)  Activiteitenbesluit  milieubeheer.  https://wetten.overheid.nl/BWBR0022762/2022-
07-01/ 
8      No  emissions  for  Cyprus  and  Greece  are  included  in  these  figures.  As  Cyprus  had  no  operational 
crematoria  as  of  2019,  and  the  first  crematorium  opened  in  Greece  in  2019,  the  figures  reported  to 
CLRTAP are considered a near-complete EU27 picture. 

9   EEA (2019). EMEP/EEA air pollutant emission inventory guidebook 2019 : 5.C.1.b.v Cremation 2019. 

https://www.eea.europa.eu/publications/emep-eea-guidebook-2019/part-b-sectoral-guidance-
chapters/5-waste/5-c-1-b-v/view 

128 

 
 
 
                                                           
available  data  sources  and  through  stakeholder  consultation  for  Denmark,  Finland,  and 
France. 

Informed  by  the  data  available  for  a  small  subset  of  countries,  as  well  as  the  average 
crematorium  annual  capacity  calculated  for  each  Member  State,  the  total  number  of 
crematoria in  each Member State was manually  allocated to  the annual  capacity bands; 
these  allocations  are  displayed  in  Table  3-5.  As  outlined,  these  figures  have  been 
obtained based on a number of assumptions in the absence of any specific national data 
and are therefore subject to high uncertainty. 

The table also presents data for 2030; the number of crematoria by capacity band in each 
Member  State  in  2019  were  adjusted  to  2030  based  on  the  anticipated  change  in 
cremation  numbers  between  those  two  years.  Where  the  change  in  cremations  between 
2019-2030 is forecast to be less than ±10%, it was judged that the change in cremation 
numbers  could  be  absorbed  by  existing  crematoria  numbers,  and  no  adjustment  was 
applied. 

The  data  indicate  that  Spain  has  the  largest  number  of  crematoria  (434)  in  2019  and 
2030, followed by France and Germany. Looking at the EU27 as a whole, over half of 
crematoria  in  2019  and  2030  are  in  the  smallest  capacity  band  (<1,000  cremations  per 
year). Most countries are expected to see an increase in the number of crematoria from 
2019 to 2030. 

Table 7: Number of crematoria by capacity band by Member State (2019 and 2030) 

Member 
State 

Number  of  crematoria,  2019  (by  capacity 
band) 

Number  of  crematoria,  2030  (by  capacity 
band) 

<1k 

1k  – 
k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k  Total  <1k 

1k  – 
2k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k  Total 

AT 

BE 

BG 

CY 

CZ 

DE 

DK 

EE 

EL 

ES 

FI 

1 

1 

1 

0 

2 

8 

1 

2 

1 

434 

10 

0 

0 

0 

3 

12 

2 

3 

0 

0 

5 

4 

6 

0 

0 

10 

2 

4 

0 

0 

4 

3 

4 

0 

0 

4 

1 

1 

0 

0 

2 

13 

19 

1 

0 

27 

1 

1 

1 

0 

2 

3 

4 

0 

0 

5 

6 

7 

0 

0 

10 

3 

5 

0 

0 

4 

4 

5 

0 

0 

4 

1 

1 

0 

0 

2 

18 

24 

1 

0 

27 

22 

50 

30 

38 

11 

159 

11 

29 

67 

40 

51 

15 

213 

6 

0 

0 

0 

4 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 

2 

0 

0 

0 

0 

19 

2 

1 

1 

4 

1 

434 

434 

12 

0 

0 

0 

20 

4 

16 

7 

0 

0 

0 

5 

0 

0 

0 

0 

0 

0 

0 

0 

0 

1 

2 

0 

0 

0 

0 

22 

4 

1 

434 

27 

129 

 
 
 
Member 
State 

Number  of  crematoria,  2019  (by  capacity 
band) 

Number  of  crematoria,  2030  (by  capacity 
band) 

<1k 

1k  – 
k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k  Total  <1k 

1k  – 
2k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k  Total 

FR 

HR 

HU 

IE 

IT 

LT 

LU 

LV 

MT 

NL 

PL 

PT 

RO 

SE 

SI 

SK 

88 

71 

21 

0 

1 

5 

0 

1 

1 

0 

2 

1 

29 

19 

26 

0 

0 

0 

0 

0 

0 

0 

0 

66 

24 

0 

1 

0 

0 

6 

12 

13 

17 

1 

4 

4 

0 

25 

24 

0 

0 

0 

0 

6 

0 

5 

0 

0 

3 

0 

5 

0 

8 

0 

0 

1 

0 

1 

7 

3 

0 

2 

0 

0 

1 

0 

5 

0 

2 

1 

0 

0 

0 

1 

2 

4 

0 

0 

0 

1 

1 

1 

3 

0 

1 

0 

0 

0 

0 

1 

1 

2 

0 

2 

2 

2 

185 

110 

89 

26 

1 

17 

7 

0 

1 

9 

0 

1 

2 

0 

2 

2 

4 

0 

5 

0 

85 

46 

30 

41 

13 

0 

0 

0 

0 

0 

0 

0 

0 

80 

29 

0 

1 

0 

0 

7 

0 

0 

2 

0 

1 

21 

23 

30 

12 

1 

5 

4 

0 

58 

28 

27 

2 

3 

0 

0 

0 

0 

6 

0 

6 

0 

0 

3 

0 

2 

0 

0 

1 

1 

1 

0 

99 

52 

20 

4 

1 

0 

5 

0 

3 

2 

0 

0 

0 

1 

4 

4 

0 

0 

0 

2 

1 

1 

3 

0 

2 

0 

0 

0 

0 

1 

2 

2 

0 

2 

2 

4 

231 

1 

17 

13 

135 

2 

1 

2 

0 

120 

92 

20 

5 

65 

2 

6 

EU-27 

685 

211 

165 

70 

67 

33 

1,231  762 

274 

224 

94 

87 

42 

1,482 

Table 8: Number of crematoria by capacity band by Member State (2019 and 2030) 

Member 
State 

Number  of  crematoria,  2019  (by  capacity 
band) 

Number  of  crematoria,  2030  (by  capacity 
band) 

<1k 

1k  – 
2k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k 

Total  <1k 

1k  – 
2k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k 

Total 

AT 

BE 

BG 

1 

1 

1 

2 

3 

0 

4 

6 

0 

2 

4 

0 

3 

4 

0 

1 

1 

0 

13 

19 

1 

1 

1 

1 

3 

4 

0 

6 

7 

0 

3 

5 

0 

4 

5 

0 

1 

1 

0 

18 

24 

1 

130 

 
 
 
Member 
State 

Number  of  crematoria,  2019  (by  capacity 
band) 

Number  of  crematoria,  2030  (by  capacity 
band) 

<1k 

1k  – 
2k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k 

Total  <1k 

1k  – 
2k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k 

Total 

0 

5 

0 

10 

0 

4 

0 

4 

0 

2 

0 

27 

0 

2 

0 

5 

0 

10 

0 

4 

0 

4 

0 

2 

0 

27 

22 

50 

30 

38 

11 

159 

11 

29 

67 

40 

51 

15 

213 

CY 

CZ 

DE 

DK 

EE 

EL 

ES 

FI 

FR 

HR 

HU 

IE 

IT 

LT 

LU 

LV 

MT 

NL 

PL 

PT 

RO 

SE 

SI 

SK 

0 

2 

8 

1 

2 

1 

434 

10 

0 

0 

0 

6 

0 

0 

0 

4 

3 

12 

88 

71 

21 

0 

1 

5 

0 

1 

1 

0 

2 

1 

29 

19 

26 

0 

0 

0 

0 

66 

12 

1 

4 

0 

0 

0 

0 

24 

0 

1 

0 

0 

6 

13 

17 

4 

0 

6 

0 

5 

0 

0 

25 

24 

0 

0 

0 

0 

0 

0 

0 

0 

0 

3 

0 

5 

0 

8 

0 

0 

1 

0 

1 

7 

3 

0 

2 

0 

0 

0 

0 

0 

0 

1 

1 

0 

5 

0 

2 

1 

0 

0 

0 

1 

2 

4 

0 

0 

0 

1 

2 

0 

0 

0 

0 

1 

1 

3 

0 

1 

0 

0 

0 

0 

1 

1 

2 

0 

2 

2 

2 

19 

2 

1 

1 

4 

1 

434 

434 

12 

0 

0 

0 

20 

4 

16 

7 

0 

0 

0 

5 

185 

110 

89 

26 

1 

17 

7 

0 

1 

9 

0 

1 

2 

0 

2 

2 

0 

0 

0 

0 

0 

4 

0 

5 

0 

85 

46 

30 

41 

13 

1 

1 

1 

0 

0 

0 

0 

0 

0 

0 

0 

0 

99 

80 

29 

0 

1 

0 

0 

7 

0 

0 

2 

0 

1 

52 

21 

23 

30 

12 

20 

4 

1 

5 

4 

0 

58 

28 

27 

2 

3 

0 

0 

0 

0 

6 

0 

6 

0 

0 

3 

0 

2 

0 

0 

0 

0 

0 

0 

1 

1 

0 

5 

0 

3 

2 

0 

0 

0 

1 

4 

4 

0 

0 

0 

2 

2 

0 

0 

0 

0 

1 

1 

3 

0 

2 

0 

0 

0 

0 

1 

2 

2 

0 

2 

2 

4 

131 

22 

4 

1 

434 

27 

231 

1 

17 

13 

135 

2 

1 

2 

0 

120 

92 

20 

5 

65 

2 

6 

 
 
Member 
State 

Number  of  crematoria,  2019  (by  capacity 
band) 

Number  of  crematoria,  2030  (by  capacity 
band) 

<1k 

1k  – 
2k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k 

Total  <1k 

1k  – 
2k 

2k  – 
3k 

3k  – 
4k 

4k  – 
5k 

>5k 

Total 

EU-27 

685 

211  165  70 

67 

33 

1,231  762 

274  224  94 

87 

42 

1,482 

In  defining  an  assessment  baseline,  the  study  has  adopted  a  bottom-up  approach  to 
quantifying  emissions.  This  involved  exploring  trends  and  activity  levels  in  the 
underlying  drivers  in  order  to  build  up  to  an  estimate  of  crematoria  emissions.  This 
method is detailed in the following section. 

Approach 

Mercury  emissions  from  crematoria  are  influenced  by  a  number  of  underlying  drivers 
including the following: 

  Mercury content of corpses, which is determined predominantly by the presence 

of dental amalgam restorations 

  The  prevalence  of  cremation  relative  to  other  funeral  options.  This  can  be 

expressed as a cremation rate, and varies significantly across the EU27 

  The  level  of  uptake  of  emissions  abatement  technologies,  which  have  varying 

mercury removal efficiencies 

In  constructing  an  assessment  baseline,  these  underlying  drivers  have  been  considered 
separately  before  they  were  drawn  together  to  estimate  crematoria  emissions.  The 
framework  for  combining  these  separate  factors  into  a  quantified  reference  scenario  of 
mercury  emissions  from  crematoria  is  set  out  in  Figure  7,  and  includes  the  following 
steps: 

  The annual cremation rate is defined 

  Total mercury content among corpses is estimated based on (i) the estimated body 
mercury  content  for  different  age  groups,  and  (ii)  the  number  of  deaths  per  age 
group 

  The proportion of crematoria fitted with emissions abatement systems is defined 
and, where data  are  available, a distinction  can be drawn between crematoria at 
different annual operating capacities 

  The mercury removal efficiencies of emissions abatement systems are accounted 

for 

The framework is applied to each Member State separately to account for variation in the 
drivers across the EU, and emissions for the EU as a whole can be aggregated from the 
granular data. 

132 

 
 
 
Figure 8: Framework for quantifying baseline mercury emissions from crematoria 

Annual crematoria 
mercury emissions

Cremation rates

Total corpse mercury 
content

Body mercury content 
by age group

Deaths by age group

Proportion of 
crematoria fitted with 
abatement technology

Number of crematoria 
at different operating 
capacities

Mercury removal 
efficiency of 
abatement systems

The  following  sections  detail  the  methodologies  applied  in  quantifying  the  underlying 
drivers, and how they have been forecast into the future to provide a future baseline with 
no further EU intervention. 

Cremation rates 

Data on national annual cremation rates are collated by the Cremation Society; these are 
displayed in Figure 8. Data for each Member State were obtained for the period 2010 to 
2019 where available and used to extrapolate historical trends to future baseline years of 
2025 and 2030 using a linear regression. For Spain and Portugal, there is no discernible 
trend in the historical data upon which to base future projections, therefore the cremation 
rates  for  2019  were  adopted  for  future  years.  There  are  challenges  in  projecting  future 
cremation  rates  for  countries  with  no,  or  very  low,  cremations  in  2019.  Data  indicates 
that neither Malta nor Cyprus operated any crematoria in 2019, while Greece saw its first 
crematorium commence operation that year. With no reliable indication from past trends 
as to how future cremation rates may evolve in these countries, it has been assumed that 
rates will remain at their current low levels. 

133 

 
 
 
Figure 9: National annual cremation rates (2019, 2025 and 203010) 

Complete data are available only up to the year 2019 and therefore do not reflect changes 
brought  about  by  the  COVID-19  pandemic.  Limited  data  on  2020  cremation  rates  in 
some Member States were accessed during targeted stakeholder consultation11. Although 
most cremation rates had increased in 2020 in comparison to 2019 rates, the amount by 
which  they  increased  varied  greatly,  and  some  Member  States  even  saw  modest 
decreases  in  cremation  rates  (the  Netherlands  and  Sweden).  The  largest  increases  were 
seen in countries with very low cremation rates in 2019, for example Greece which saw a 
435% increase from 2019-2020 but only observed a 0.4% cremation rate in 2019. Most 
other  Member  States  for  which  data  is  available  saw  an  increase  closer  to  5-7%  from 
2019  rates.  Therefore,  it  is  likely  that  the  COVID-19  pandemic  caused  an  increase  in 
cremation  rates  in  some  Member  States.  However,  data  is  too  limited  at  this  point  to 
make  an  informed  assessment  of  how  the  pandemic  affected  rates  above  the  increase 
already  expected  by  changing  funerary  trends  in  the  EU.  It  is  also  expected  that  as  the 
pandemic diminishes, cremation rates will return to pre-pandemic trends. Consequently, 
future  projections  are  based  solely  on  pre-pandemic  trends.  There  is,  however, 
uncertainty concerning nearer-term trends in cremation rates. 

10   Data obtained from The Cremation Society (2021). In the absence of cremation rates for the following 
Member States, rates for other Member States were used as a proxy: Bulgaria (Romania used as proxy); 
Latvia and Estonia (Lithuania used as proxy); Croatia (average of Hungarian and Slovenian rates used); 
Slovakia (Czechia used as proxy). 

11   2020 Cremation Rates for BG, CZ, DE, DK, EL, FI, HU, IE, LT, NL, PT, SE and SL were provided via 

direct correspondence with the International Cremation Federation on 25th July 2022.  

134 

 
 
 
 
                                                           
In  the  absence  of  any  more  granular  data,  it  was  assumed  that  cremation  rates  are 
uniform across deaths in different age groups within a country (i.e., a 50% cremation rate 
in Austria in 2019 means that 50% of individuals that die at age 50 are cremated, 50% 
that die at age 51 are cremated, etc.). 

Mercury content of corpses 

The  mercury  content  for  corpses  has  been  calculated  for  each  Member  State.  This  was 
based  on  (i)  the  mean  number  of  decayed,  missing  and  filled  teeth  (DMFT)  for  each 
Member State; (ii) the relative share of amalgam use in dental restorations and; (iii) the 
typical mercury content of a dental amalgam filling. Details on this methodology are set 
out  in  the Section  above, which discusses the baseline for the dental amalgam  problem 
area. For each Member State and for each year group, a lower, mean and upper value was 
produced for the mercury content per corpse to account for the uncertainty in the share of 
amalgam use. Additionally, the future share of amalgam use in different Member States 
has been estimated based on the available data. 

Dental  amalgam  restorations  in  bodies  arriving  at  crematoria  will  have  been  fitted  in 
varying years, which will have had varying rates of dental amalgam use. Consequently, it 
is  necessary to  account  for the lag in  a dental  amalgam  restoration being made,  and its 
arrival  at  a  crematorium.  A  study  concluded  that  the  average  age  of  replaced  amalgam 
fillings is 15.3 ± 6.6 years12. Therefore, for any given assessment year, the rate of dental 
amalgam  use  in  restorations  was  based  on  the  average  dental  amalgam  share  over  the 
lifetime of the restoration; this accounts for the fact that a restoration could be any age up 
to 15.3 ± 6.6 years. For example, the dental amalgam share used in estimating emissions 
from crematoria for the year 2019 was based on the average dental amalgam share over 
the years 2004 to 2019. As a sensitivity test, longer (21.9 years) and shorter (8.7 years) 
amalgam lifespans were used in calculating a higher and lower estimate, respectively. 

Data on historical deaths by age group are available from Eurostat; figures for 2019 were 
obtained  from  the  demo_magec  dataset13.  The  dataset  also  includes  figures  for  2020  at 
5.2  million  deaths  in  the  EU27,  compared  with  4.7 million  deaths  in  2019,  2018  and 
2017. This increase in deaths is attributable to the COVID-19 pandemic and, as discussed 
in the context of cremation rates above, increased deaths are anticipated to return to pre-
pandemic trends as the pandemic abates. As such, 2019 has been selected as the baseline 
year that would be most consistent with long-term projections for future year scenarios. 
Eurostat  also  includes  future  population  projections  by  year  group  (dataset  proj_19np) 
and  forecasts  for  probability  of  dying  by  age  in  future  years  (proj_19naasmr).  These 
datasets were combined to provide projections for the number of deaths by age group in 
2030. 

The  mass  of  mercury  in  all  corpses  was  then  quantified  by  combining  the  figures  on 
mercury  content  per  body  with  the  number  of  deaths  per  corresponding  age  group.  By 
applying the cremation rates determined above, the mass of mercury in corpses reaching 
crematoria was calculated. Masses for each Member State are displayed in Figures 9, 10 
and 11. The figures indicate that the mass of mercury reaching crematoria is decreasing 

12      Kirsch  et  al.  (2016)  Decision  criteria  for  replacement  of  fillings:  a  retrospective  study. 

https://doi.org/10.1002/cre2.30 

13   European Commission (2022). Eurostat. https://ec.europa.eu/eurostat/data/database 

135 

 
 
                                                           
from 2019 to 2030 in most Member States with a few exceptions, most notably Poland. 
The increase in these countries appears to be driven by increasing rates of cremation as 
well as increased mortality resulting from aging populations. 

Figure 10: Masses of mercury in corpses reaching crematoria (low estimates) for 2019, 2025 
and 2030 

Figure 11: Masses of mercury in corpses reaching crematoria (central estimates) for 2019, 
2025 and 2030 

136 

 
 
 
 
 
Figure  12:  Masses  of  mercury  in  corpses  reaching  crematoria  (high  estimates)  for  2019, 
2025 and 2030 

Uptake of emissions abatement technologies 

Data  on  uptake  of  emissions  abatement  technologies  at  crematoria  for  some  OSPAR 
members have been collated via the following phased approach: 

  Where  up-to-date  information  was  provided  through  the  stakeholder  survey  and 

consultations, this was adopted as the default assumption 

  Where no stakeholder response was provided, but data were available from other 

sources, assumptions were made based on these sources 

  For Member States where there was neither a stakeholder response, nor any data 
in the literature, it was conservatively assumed that emissions abatement uptake 
was  0%  where  there  was  no  evidence  of  regulation  addressing  crematoria 
emissions 

Assumed abatement uptake rates are displayed in Table 9 below. 

Table 9: Percentage of crematoria with/without abatement technologies 

Member 
State 

AT 

BE 
BG 
CY 
CZ 
DE 
DK 

Crematoria 
with 
abatement (%) 
30 

100 
0 
0 
0 
100 
95 

Source / notes 

30% uptake in 2005. No requirements for crematoria emissions identified; 
uptake rate conservatively assumed to remain at 2005 levels. 
Targeted stakeholder survey response. 
No survey response; assumed to be 0%. 
No crematoria in Cyprus. 
0% uptake in 2018; assumed to be at same level2. 
Targeted stakeholder survey response. 
Targeted stakeholder survey response. 

137 

 
 
 
 
Member 
State 

EE 
EL 
ES 
FI 

FR 
HR 
HU 
IE 
IT 
LT 
LU 
LV 
MT 
NL 
PL 
PT 
RO 
SE 
SI 
SK 

Crematoria 
with 
abatement (%) 
0 
0 
4 
0 

100 
0 
70 
71 
90 
100 
100 
0 
0 
100 
0 
0 
0 
83 
0 
0 

Source / notes 

No survey response; assumed to be 0%. 
No survey response; assumed to be 0%. 
Assumed consistent with 2014 data in OSPAR 2016 report14. 
OSPAR  member,  but  no  survey  response  provided  and  no  information 
found  indicating  any  regulation  in  place.  Previous  assessment  work  does 
not identify any regulation addressing mercury emissions from crematoria. 
Assumed to be 0%. 
100% uptake in 2018; assumed to be at same level2. 
0% uptake in 20181; assumed to be at same level2. 
Targeted stakeholder survey response. 
Targeted stakeholder survey response. 
Targeted stakeholder survey response. 
Targeted stakeholder survey response. 
Assumed consistent with 2014 data in OSPAR 2016 report14. 
No survey response; assumed to be 0%. 
No crematoria in Malta. 
Assumed consistent with 2014 data in OSPAR 2016 report14. 
No survey response; assumed to be 0%. 
Targeted stakeholder survey response. 
No survey response; assumed to be 0%. 
Targeted stakeholder survey response. 
No survey response; assumed to be 0%. 
No survey response; assumed to be 0%. 

Historical data on the uptake of emissions abatement systems at crematoria are lacking, 
nor  was  any  information  obtained  through  the  stakeholder  survey.  It  was  therefore  not 
possible to project uptake trends into the future and it was therefore assumed that, under 
a business-as-usual baseline scenario, future uptake of abatement systems would remain 
at the same level as the historical data. 

Data  on  the  percentage  of  cremations  carried  out  by  crematoria  falling  into  different 
annual  operating  classes  was  also  requested  through  the  survey  (e.g.,  fewer  than  1,000 
cremations  a  year,  over  5,000  cremations  a  year,  etc.).  Information  was  received  for  a 
number  of  Member  States  (Germany,  Ireland  and  Sweden),  and  publicly  available  data 
were  used  for  several  other  Member  States  (Finland,  France  and  Denmark).  For  other 
Member  States,  the  distribution  of  cremations  into  different  capacities  was  estimated 
based on the average cremation capacity in the country. The total number of crematoria 
in  each  Member  State,  obtained  from  the  Cremation  Society,  was  then  manually 
apportioned into each operating capacity. Total emissions can therefore be disaggregated 
by  crematoria  size  to  identify  whether  larger  or  smaller  installations  are  currently  the 
greatest sources of emissions. 

14   OSPAR Commission (2016) Implementation of OSPAR Recommendation 2003/4 on Controlling the 
assessment. 

Crematoria: 

Overview 

Second 

from 

Dispersal 
https://www.ospar.org/documents?v=35427 

Mercury 

of 

138 

 
 
 
                                                           
In the absence of capacity-specific abatement uptake rates, it was assumed that abatement 
rates are constant across all capacity bands. 

Mercury removal efficiency of abatement systems 

For  the  assessment,  it  has  been  assumed  that  100%  of  mercury  reaching  crematoria  in 
corpses is emitted to air during cremation; while in reality a small proportion of mercury 
released from a cremation will adhere to the surfaces of the crematorium or remain in the 
ash.  This  assumption  is  considered  a  generally  accurate  approximation  of  operating 
conditions15.  Data  collated  from  the  literature  on  mercury  removal  efficiencies  for  the 
most widely used abatement technologies are displayed in Table 4.  

Table 10: Mercury removal efficiency of different abatement technologies 

Technology 

Lower 
(%) 

value 

Upper 
(%) 

value 

Source / notes 

Unabated emissions 

Injection of adsorbent 
(AC) 

0.0 

90.0 

0.0 

98.0 

Solid bed filtration 
using adsorbent (AC) 

90.0 

99.9 

Assumed 100% of mercury mass 
reaching crematoria are emitted to air 
Lower value: Umwelt Bundesamt 
(2021)16 
Upper value: OSPAR Commission 
(2003)17 
OSPAR Commission (2003) 

Data on the relative uptake of specific abatement technologies in Member States was not 
available,  and  therefore  it  was  not  possible  to  apply  technology-specific  removal 
efficiencies  in  calculating  emissions.  Information  on  typical  removal  efficiencies  was 
sought  from  Member  States  through  the  consultation  activities;  data  received  are 
displayed in Table 5. 

Table 11: Typical mercury removal efficiency reported by Member States 

Member 
State 

DE 

DK 
IT 
SE 

Typical 
removal 
(%) 
90 – 98 

98 
90 – 95 
97 

mercury 
efficiency 

Notes 

Response  states  that  carbon  injection  is  the  BAT,  with  a 
removal efficiency of 90-98% (see Table) 
- 
- 
- 

15   Piagno and Afshari (2020). Mercury from crematoriums: human health risk assessment and estimate of 

total emissions in British Columbia. https://doi.org/10.17269%2Fs41997-020-00327-0 

16      Umwelt  Bundesamt  (2021). Text  68/2021:  Quecksilberemissionen  aus  industriellen  Quellen  –  Status 
2. 

Quo 
https://www.umweltbundesamt.de/sites/default/files/medien/5750/publikationen/2021-04-26_texte_68-
2021_quecksilberemissionen_teil_2_0.pdf 

Abschlussbericht 

Perspektiven 

Teil 

und 

- 

17      OSPAR  Commission  (2003).  Mercury  emissions  from  crematoria  and  their  control  in  the  OSPAR 

Convention Area. https://www.ospar.org/documents?v=6971 

139 

 
 
 
 
                                                           
Where no further country-specific removal efficiency could be obtained, an upper value 
of 99.9% was assumed along with a lower value of 90% and a central estimate of 95%. 
This  was  based  on  reported  removal  efficiencies  for  carbon  injection  and  solid  bed 
filtration (see Table 5), the most widely used abatement technologies. 

There is limited information in the literature to indicate that mercury removal efficiencies 
have changed historically as a result of improvements to existing systems, or introduction 
of  new  technologies.  Emissions  estimates  are  therefore  based  on  the  assumption  that 
removal efficiencies will remain constant into the future. 

Summary 

Crematoria  mercury  emissions  have  been  calculated  by  combining  the  data  on  the 
underlying drivers, discussed above. Estimated emissions for individual Member States 
in  2019,  2025  and  2030  are  presented  in  Figure  12,  and  for  the  EU27  as  a  whole  in 
Figure 13 (below). 

Total mercury emissions for the EU27 are estimated at 689 kg in 2019. This is slightly 
lower  than  the  figure  reported  to  the  CLRTAP  (0.9  tonnes).  Figures  reported  to  the 
CLRTAP are largely based on Tier 1 emission factors dating from 1992, which represent 
an  average  of  crematoria  both  with  and  without  abatement  systems.  As  uptake  of 
emissions abatement technologies has likely increased since these emissions factors were 
produced, it is likely that they overestimate emissions in 2019. 

Emissions are forecast to gradually decline to 519 kg in 2025, and 355 kg in 2030. All 
Member States are predicted to see a decline in emissions over this period. 

Figure 13: Estimated mercury emissions from crematoria (2019, 2025 and 2030) 

140 

 
 
 
 
 
Figure  14:  Estimated  mercury  emissions  per  Member  State  from  crematoria  (2019,  2025 
and 203018) 

18 Error bars denote lower and higher emissions estimates. 

141 

 
 
 
 
                                                           
3.  Baseline for MAPs 

Approach 

The purpose of the baseline scenario is to predict manufacture and export of MAPs, the 
associated  mercury  use  and  the  probable  impacts  in  the  near  future.  While  the  relevant 
legal framework in the EU is considered as constant (taking into account restriction that 
will enter into force the coming years), the legal situation in importing countries and on 
the global level is currently changing or may change soon. The legal situation as well as 
national programmes/ initiatives that will lead to a change of demand products exported 
from the EU was analysed and considered. Moreover, rising environmental awareness, as 
well  as  technical  progress  and  increasing  price  competitiveness,  may  also  lead  to  a 
decline in end-user demand. Such developments are indicated by past and current trends 
in  export  volume  or  sale  patterns  in  importing  countries.  Such  data  are  available  for 
lamps, but time series may not be readily at hand for other relevant products. In that case, 
opinions from industry experts were invited to allow at least rough estimates about future 
trends. 

On the background of these considerations, a baseline scenario was calculated covering 
central boundary conditions of future developments: 

  No further legal actions in the EU beyond those already agreed or planned to take 
place in the near future, but consideration of existing legal measures in importing 
countries that become effective in the near future  

  The  impact  of  potential  national  measures  in  importing  countries  that  follow  or 
lead to similar results as the EU restrictions laid down in the RoHS directive and 
the subsequent Commission regulations.  

The  baseline  scenario  considers  that  several  countries  have  implemented  legislation  or 
are  considering  adopting  legislation  that  mirrors,  at  least  in  part,  European  product-
related  law,  especially  the  REACH  regulation,  the  RoHS  Directive,  and  the  Ecodesign 
Directive  and  any  associated  delegated  acts.  Furthermore,  the  legal  situation  in  some 
selected countries or regions were looked at in more detail.  

For  these  scenarios,  future  exports  of  relevant  MAPs  in  terms  of  number,  value,  and 
mercury content were estimated based on identified current  and past trends. Trend data 
were available only for compact fluorescent lamps (CFL) and double-capped fluorescent 
lamps (linear and non-linear  FL). Almost  all lamps of these types  are  addressed by the 
recent Delegated Acts under the RoHS directive so that data on past trends will allow the 
prediction of impacts of future measures.  

The  situation  is  different  for  high-intensity  discharge  lamps  (HID,  HPS,  HPMV,  MH). 
Although export data are available for this group, only a part of export is related to lamp 
types banned within the EU.  

Limited  information  from  other  sources  could  be  gathered  to  allow  an  overview  of  the 
situation and trends for other relevant products within the scope of the present study. For 
them, no quantitative recent export data were available and there is currently no basis to 
predict future trade volumes.  

The  export  value  and  the  amount  of  mercury  in  CFLs  and  double-capped  FLs  was 
estimated  for  the  years  2025  to  2030.  For  importing  countries,  it  was  calculated  how 

142 

 
 
 
much  mercury  will  likely  end  up  in  the  environment  due  to  inappropriate  waste 
management  practices.  Minamata  Initial  Assessments  (MIAs)  as  well  as  reports  on 
mercury  waste  management  provided  an  indication  which  percentage  of  mercury  in 
products is likely to be released during disposal. 

Based  on  the  problem  description,  three  groups  of  MAPs  were  selected  for  which 
quantitative or at least semi quantitative data on export volumes were available: 

  CFL lamps for general lighting purposes 

  LFL lamps for general lighting purposes except those addressed by RoHS Annex 

III 2(b)4 

  Dental amalgam 

These  three  product  groups  most  likely  constitute  the  vast  majority  of  MAPs  both  in 
number as well as in value currently exported from the EU. 

Expected global market development: fluorescent lamps 

According to a study by the IEA (2021)19, fluorescent lamps for general lighting purposes 
continue  to  lose  significant  market  share.  Their  share  (CFL+LFL)  of  the  global  market 
fell from 43% to 33% between 2013 and 2020. In turn, the share of LED lamps rose from 
3%  to  51%.  While  market  penetration  in  industrialised  countries  is  already  well 
advanced, the situation in less developed countries is still somewhat different. A higher 
share  of  non-LED  lamps  is  also  observed  in  existing  light  sources.  The  authors  of  the 
IEA study expected that the LED share of the total market will increase to close to 100% 
by 2025. In the authors’ view, there are several reasons for this: 

  The price of LED lamps and light sources continues to fall relative to other lamp 

types, making them even more competitive. 

  The energy efficiency of LEDs has continued to increase and has doubled in five 
years.  It  is  now  on  average  well  above  that  of  CFLs  and  slightly  above  that  of 
LFLs. A further increase (doubling again) is technically possible but is expected 
to  be  slower.  In  contrast,  no  further  increase  in  efficiency  can  be  expected  for 
fluorescent lamps. 

  The  use  of  energy-saving  LEDs  are  a  low-hanging  fruit  to  decrease  energy 
consumption  and  to  contribute  achieving  climate  goals.  Many,  especially  less 
developed  countries  (e.g.,  India)  have  started  programmes  to  make  LEDs 
accessible to broad sections of the population. 

In  an  earlier  publication,  the  IEA  predicted  a  less  optimistic  expectation  of  future 
developments.  It  is  no  longer  available  online  but  cited  in  a  recent  JRC  report20. 
According  to  this  prediction,  LED  would  dominate  the  market  in  2025  with  a  75.8% 
market  share  and  would  further  rise  to  87%  in  2030.  In  this  scenario,  the  share  of 
fluorescent  lamps would decrease to  a market  share of 23.5% in  2025 and to  12.5% in 
2030. This prediction may be more realistic as for example in the EU many exemptions 

19 

(2021)  Lighting.  Tracking  Report 

IEA 
–  November 
https://www.iea.org/reports/lighting (last checked 12 March 2022) 

2021.  Available 

online 

at: 

20   Zissis, G.; Bertoldi, P.; Serrenjo, T. (2021) Update on the Status of LED-Lighting world market since 

2018. JRC Tech. Rep. JRC122760 

143 

 
 
                                                           
for lamps extend to 2025 or beyond. A global ban for all remaining fluorescent lamps for 
general  lighting  purposes  cannot  be  agreed  before  COP5  of  the  Minamata  Convention 
(2023)  and  would  enter  into  force  not  earlier  than  two  years  after  (rather  considerably 
later, considering the extended time needed for national ratification and preparation).  

In the area of street lighting, the share of LED lamps in new installations is expected to 
rise to 80% already in 2020, reaching 89% globally in 2017. Replacing existing sodium 
lamps  with  LEDs  usually  requires  higher  investments  and  pays  off  only  over  a  longer 
period (4-12 years), so it will progress more slowly. The focus of investment will be in 
Europe,  North  America,  and  South  Asia,  while  countries  in  the  Arab  region  and 
Southeast Asia will continue to prefer traditional solutions. 

A  summary  study  of  CLASP  concluded  that  48%  of  European  exports  go  to  countries 
that have RoHS-like regulations, which will also phase out CFL and LFL by 2024/202521. 
In  addition,  it  must  be  taken  into  account  that  61%  of  current  production  is  shipped  to 
other EU countries, a market that will disappear in 2023. Thus, about 80% of the current 
CFL  and  LFL  production  would  no  longer  find  a  market  by  the  end  of  2025  and  may 
pose  a  serious  challenge  for  the  few  remaining  EU  manufacturers  to  maintain  their 
manufacturing lines. 

Another  major  incentive  to  accelerate  the  shift  to  LEDs  are  the  strongly  increasing 
energy-prices observed since 2021 due to  the  combined effect  of higher  demand in  the 
course  of  economic  recovery  after  the  COVID-19  pandemic  and  the  aftermath  of  the 
Russian invasion of Ukraine. Higher energy prices will likely strengthen the demand for 
more cost-effective LEDs. However, it is too early to quantify the effect. 

Business-as-usual scenario  

In the baseline scenario, it was assumed that the EU does not take any further measures 
to  restrict  MAP  exports.  Global  restrictions  agreed  at  COP4.2  of  the  Minamata 
Convention  were taken into  account.  The decrease in  exports  was extrapolated into the 
future  according  to  the  observed  continuous  development  from  2008  to  2020.  This 
represents an average global trend that already includes more or less ambitious measures 
taken by non-EU countries in the past. 

In  addition  to  that,  based  on  historical  experience  and  observed  legal  practice,  it  is 
considered that the EU is a forerunner in product-related policy and that countries outside 
the  EU  may  decide  to  translate  restrictions  imposed  in  the  EU  into  their  national 
legislation  (especially  the  most  recently  adopted  restrictions  on  CFL  and  LFL). 
Depending  on  national  circumstances  and  ambition,  this  will  probably  take  place  with 
some  delay  and  possibly  only  in  part  (see  RoHS,  Ecodesign).  Moreover,  third  country 
manufacturers that export products to the EU need to comply with EU rules. Establishing 
a RoHS-compliant product line while maintaining a non-compliant line causes extra costs 
in research and production so that even without domestic legislation EU law could have 
an effect.  

An  overview  was  prepared  to  gain  an  impression  of  how  many  years  later  the  main 
recipient countries may follow the EU example or implement policies with a comparable 

21 CLASP (2022) Refurbishing Europe’s Fluorescent Lamp Manufacturing Facilities 

144 

 
 
                                                           
effect (Table 9). According to the analysis, the ten countries with the highest share in EU 
exports could be categorized in five groups: 

 

Identical rules with no delay: Switzerland, Norway 

  Similar rules in 2028: United Kingdom  

  Similar rules in 2030: Russian Federation, United Arab Emirates 

  Partially similar rules in some states: United States 

  No additional national  measures before  2031:  China, Egypt,  Republic  of Korea, 

Saudi Arabia, Turkey 

Table 12: RoHS-like legislation/programmes/standards in main recipient countries 

Country 

RoHS 1 (2003) 

RoHS 2(2011)  Years  between  EU  RoHS  and 

China 
Egypt 
Norway 

Republic of Korea 

2008 (lamps are 
not included) 

Russia/ Eurasian Union 

2005 

2012 

2012 

Saudi Arabia 
Switzerland 

Turkey 
United Arab Emirates 
United Kingdom 

USA 

Turkey 
United Arab Emirates 
United Kingdom 

USA 

2018 

2013 

national RoHS-like legislation 

7 
Not applicable 
2 (but exemptions and entry into effect 
identical) 
Not applicable 

2016 (adopted 
by Member 
States in 2018) 
2021 

201731 

Different 
approach 
(incentives) 

201722 

Different 
approach 
(incentives) 

7 

10 
2 (but exemptions and entry into effect 
identical) 
9 
6 
So far consistent (including ban on 
CFL.i and c, but UK may decide 
differently/ later on new product bans 
Not applicable 

9 
6 
So far consistent (including ban on 
CFL.i and c, but UK may decide 
differently/ later on new product bans 
Not applicable 

For  each  country,  the  percentage  of  lamps  that  are  likely  not  affected  by  national 
measures was derived for the years 2025, 2028 and 2030 (100% or 0%, for USA: 85% 

22    Businesstat  (2021)  Between  2016  and  2020,  sales  of  electric  lamps  in  Russia  fell  by  21%:  from  960 
million to 756 million units (translates). Available at:  http://marketing.rbc.ru/articles/12262/ (last checked 
on 12 March 2022). 

145 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
and  70%,  Table  10).  These  values  were  multiplied  with  predicted  EU  exports  to  the 
individual countries. This resulted in a reduced number of total exports. 

Table  13:  Impact  of  national  policy  measures  on export  of  FLs from  the EU  (100%  =  no 
specific national impact) 

Country 
China 
Egypt 
Norway 
Rep. of Korea 
Russian Federation 
Saudi Arabia 
Switzerland 
Turkey 
United Arab Emirates 
United Kingdom 
United States 

2025-2027 
100% 
100% 
0% 
100% 
100% 
100% 
0% 
100% 
100% 
100% 
85% 

2028-2029 
100% 
100% 
0% 
100% 
100% 
100% 
0% 
100% 
100% 
0% 
85% 

2030 
100% 
100% 
0% 
100% 
0% 
100% 
0% 
100% 
0% 
0% 
70% 

Predicted export volumes in 2025 to 2030 (lamps) 

Export  data  for  discharge  lamps  was  obtained  from  the  EU-PRODCOMM  and  UN-
COMTRADE databases. 

Based  on  the  data  from  2008  to  2020,  trends  were  developed  from  which  the  future 
development  was  predicted.  The  year  2008  was  chosen  as  starting  point  because  a 
historic peak in the export volume of discharge lamps was achieved in this year. In the 
following  years,  exports  declined  continuously.  The  development  of  exports  in  this 
period can be represented by different function types. From a statistical point of view, the 
decrease in exports would be best described linearly. However, this would inevitably lead 
to a complete disappearance of exports in a few years. As long as there are still existing 
installations  that  can  be  fitted  with  fluorescent  lamps  at  low  or  no  cost,  demand  will 
continue to exist, even if the use of LEDs would be more economical in the long-term. It 
therefore  seems  more  obvious  to  describe  the  decrease  in  exports  by  an  exponential 
function.  It  also  leads  to  a  continuous  decrease,  but  it  slows  down  more  and  more.  To 
derive a bandwidth, standard deviations were calculated from the deviations between the 
smoothing  curve  and  the  reported  export  volumes.  The  upper  and  lower  limits  of  the 
range were derived from the predicted curve by adding or subtracting twice the standard 
deviation.  This  was  done  on  the  basis  of  the  logarithmic  export  figures  due  to  high 
relative differences in size between the older and more recent export figures. The range, 
therefore, becomes narrower in absolute terms, but it is constant on a relative scale. The 
following  figures  show  that  all  export  data  lie  within  or  at  least  just  outside  this  range 
(Figure 20). 

Figure 15: Reported and predicted amount and value of exported CFLs and double-capped 
FLs (incl. LFLs) between 2008 and 2030 

146 

 
 
 
 
147 

020406080100120140160200820102012201420162018202020222024202620282030Mio € Total value of exported CFLReportedBAU-1BAU-1 minBAU-1 max020406080100120140200820102012201420162018202020222024202620282030Mio. unitsCFL Exports (units)ReportedBAU-1BAU-1 minBAU-1 max050100150200250300350200820102012201420162018202020222024202620282030Mio. unitsLFL Exports (units)ReportedBAU-1BAU-1 minBAU-1 max020406080100120140160180200200820102012201420162018202020222024202620282030Mio € Total value of exported LFLReportedBAU-1BAU-1 minBAU-1 max0102030405060200820102012201420162018202020222024202620282030Mio. unitsHPS HPMV MH Exports (units)ReportedBAU-1BAU-1 minBAU-1 max050100150200250300350400450500200820102012201420162018202020222024202620282030Mio. €HPS HPMV MH Exports (value)ReportedDatenreihen4Datenreihen5 
 
  
 
 
 
 
Future development of exports can also take a different course. Decisions by individual 
manufacturers  to  rearrange  production  capacity  among  production  sites  worldwide  or 
changed international flows of goods (which affect lamps that are only distributed via the 
EU  to  countries  outside the  EU)  can influence exports beyond the calculated ranges.  It 
was observed, for example, that the value of exports decreases faster than the number of 
exported lamps – the average price achieved thus decreases so that in individual cases the 
limit  of  profitability  could  be  reached.  This  may  lead  to  an  abrupt  end  of  individual 
production lines. In addition, production exceeding annual demand has been observed in 
recent  years.  Thus,  stocks  may  have  been  built  up  in  view  of  expected  restrictions  on 
placing  on  the  market.  Reducing  these  stocks  by  relocating  them  abroad  would  lead  to 
exports that exceed expectations. 

Also,  the  legal  framework  in  the  current  export  markets  is  not  predictable.  Increased 
efforts  to  meet  climate  targets  are  already  leading  to  increased  scrutiny  of  the  lighting 
sector. A forced phase-out of less efficient fluorescent lamps could be one of the rather 
easy ways for more countries to save energy. The forecast presented here therefore only 
sketches one of several possible development paths. 

The projected exports for the BAU scenario are  summarised in  Table 11. According to 
these  and  under  BAU,  by  2025,  export  volumes  for  all  CFLs  and  LFLs  would  fall  to 
around  83-141  million  units.  By  2030,  the  numbers  would  fall  to  between  49  and  83 
million units. The calculated decrease is stronger for CFL lamps. In comparison to 2020, 
exports are predicted to decrease by 47-68%. 

The  value  of  exported  lamps  decreases  from  €92.2  million  to  approx.  €59  million  i.e., 
€42-76 million by 2025 and to €21-38 million by 2030. 

The amount of mercury exported (via CFLs and LFLs) was estimated at 450-501 kg in 
202023. This quantity would decrease to about 245-414 kg by 2025 and to about 146-246 
kg by 2030. The wide range follows from the uncertainty of the average mercury content 
of the exported lamps. 

Table  14: Baseline scenarios BAU-1  and BAU-2. Predicted  range  of export  volume,  value 
and mercury content (all FLs for general lighting purposes) in 2025, 2028 and 2030 

Parameter 

CFL (million units) 
Double-capped FL 
(million units) 
Total export (million 
units) 
CFL (million EUR) 
Double-capped FL 
(million EUR) 
Total export value 
(million EUR) 

Export 
from EU 
(2020) 
35,5 
121,6 

BAU 
2025 

15 – 32 
69 – 108 

BAU 
2028 

11 – 24 
54 – 85 

BAU 
2030 

8 – 17 
41 – 65 

157,1 

83 – 141 

65 – 109 

49 – 83 

33,6 
58,6 

92,2 

16 – 24 
26 – 52 

42 – 76 

10 – 16 
19 – 37 

7 – 11 
14 – 27 

29 – 53 

21 – 38 

23  This value was calculated on basis on of available information on the mercury content per lamp in 2022. 

The actual value in 2020 was probably higher. 

148 

 
 
                                                           
Parameter 

Mercury content CFL 
(kg) 
Mercury content in, 
double-capped FL (kg) 
Total mercury content 
(kg) 

Export 
from EU 
(2020) 
62-64 

BAU 
2025 

BAU 
2028 

BAU 
2030 

26 – 58 

19 – 43 

14 – 31 

388-438 

219 – 356 

172 – 280 

132 – 214 

450-501 

245 – 414 

192 – 323 

146 – 246 

Figure 16: Calculated and predicted total mercury content of exported discharge lamps (all 
FLs for general lighting purposes) between 2012 and 2030 

Dental amalgam 

Considering the expectations expressed in the WHO study (75% of participants expected 
a phase-out  by 2030) and data on declining use  in  the USA and Canada, it is  expected 
that  the  demand  for  EU-made  encapsulated  amalgam  will  decrease  strongly  until  2025 
and even further until 2030. That coincides with the assumption of an EU manufacturer 
who expressed that by 2025 exports would likely decrease by 25% and by 2030 by 26-
50%. On the other hand, demand may increase in those (low-income) countries that need 
to implement the recent MC COP decision to prohibit the preparation of dental amalgam 
from  bulk  mercury.  Based  on  these  assumptions  it  is  expected  that  exports  decrease 
linearly  by  25%  to  75%  of  the  current  levels  by  2030.  The  already  large  uncertainty 
concerning current dental amalgam exports only allowed a rough calculation of the order 
of future export volumes. 

Based on these assumptions the following ranges are expected: 

2025: 13 - 55 million capsules with a total mercury content 7 – 32 t 

2030: 5 - 48 million capsules with a total mercury content 3 – 28 t  

149 

01002003004005006007008009001000200820102012201420162018202020222024202620282030kgBased on mercury content per lamp in 2022Based on export dataBAU-1 minBAU-1 maxBAU-2 minBAU-2 max 
 
 
 
Figure 17: Predicted mercury content in dental amalgam exports 

150 

0510152025303540201920202021202220232024202520262027202820292030Mass of Hg [t]Predicted Hg content in exported dental amalgam 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annex 6: Problems and Drivers 

1.  The Mercury Problem 

Mercury in air  

Mercury  is  naturally  emitted  into  air  from  various  natural  sources  such  as  volcanoes, 
erosion and natural  fires.  Its accumulation in  the air in  Europe is  largely influenced by 
external sources, as it is estimated that mercury emissions from outside Europe contribute 
about  50%  of  the  anthropogenic  mercury  deposited  annually  within  the  continent,  of 
Asia
which 

originates 

30% 

in 

1,2.  Globally,  the  most  prominent  sources  of  mercury  emissions  to  air  are  artisanal  and 
small-scale gold mining (ASGM) (37%), coal combustion (24%) and non-ferrous metal 
production  (13%)3.  Most  estimates  indicate  that  global  mercury  emissions  to  the 
atmosphere stand at 2000 to 2500 t per year, with a persistence of up to two years, before 
deposition into water or soil4. Mercury emissions to air in the EU were around 200 tonnes 
in 1990 and decreased to around 60 t in 20165.  

Mercury in water 

Mercury deposited in water poses a greater danger to human health than that emitted to 
air and deposited on soil, as water can store mercury for longer periods and, under certain 
conditions, can be converted into methylmercury6,7. Data on historical and future mercury 
releases to water are less comprehensive than for air, but an approximate assessment of 
global  mercury  emissions  deposited  into  the  oceans  in  20188  concluded  that  global 
emissions  from  anthropogenic  sources  in  2015  amounted  to  around  54.6  t.  The  main 
activities contributing to this level of deposition were waste management and discharges; 
non-ferrous  metals  production;  and  coal-fired  power  plants.  It  is  estimated  that  the 
European contribution of mercury emissions to freshwater is around 8 t9.  

Mercury in European waters 

1 UNEP (2018), Global Mercury Assessment,  
https://wedocs.unep.org/bitstream/handle/20.500.11822/27579/GMA2018.pdf?sequence=1&isAllowed=y  
2 UNEP (2018), Global Mercury Assessment, 

https://wedocs.unep.org/bitstream/handle/20.500.11822/27579/GMA2018.pdf?sequence=1&isAllowed=y 
3 These emissions do not arise from mercury employed in the processes themselves, but rather because this 

is present in fuels and raw materials used. These are classified as “unintentional releases”  
4 https://www.des.nh.gov/organization/commissioner/pip/factsheets/ard/documents/ard-28.pdf  
5 European Environment Agency (2018) “Mercury in Europe’s environment. A priority for European and 

global action”, https://www.eea.europa.eu/highlights/mercury-pollution-remains-a-problem  

6 Methylmercury is formed from inorganic mercury by the action of microbes that live in aquatic systems. 
People are exposed to methylmercury when eating fish and shellfish that contain this compound or when 
inhaling mercury vapour. In pregnant women, methylmercury can adversely affect a baby’s brain and 
nervous system. Similar effects can be observed in adult population (World Health Organization).  

7 UNEP (2018), Global Mercury Assessment, 

https://wedocs.unep.org/bitstream/handle/20.500.11822/27579/GMA2018.pdf?sequence=1&isAllowed=y  

8 UNEP (2018), Global Mercury Assessment,  

https://wedocs.unep.org/bitstream/handle/20.500.11822/27579/GMA2018.pdf?sequence=1&isAllowed=y  

9 AMAP/UNEP, 2008. Technical background report to the global atmospheric mercury assessment 

151 

 
 
 
                                                           
The  EEA  State  of  Water  Report10  highlights  that  in  the  2nd  River  Basin  Management 
Plans  (2015-2021),  only  38%  of  surface  water  bodies  (e.g.,  rivers,  lakes  and  coastal 
waters)  were  reported  to  be  in  good  chemical  status;  46%  of  water  bodies  failed  to 
achieve  good  chemical  status;  and  for  16%  of  surface  water  bodies  their  status  is 
unknown. Mercury is one of the few substances responsible for a widespread failure to 
achieve  good  chemical  status  with  24  Member  States  reporting  water  body  failures 
caused by mercury.  

Across  Europe,  mercury  (alongside  brominated  diphenylethers)  is  also  responsible  for 
failure to  achieve good chemical status in the highest number of water bodies: out of a 
total of 111,062 surface water bodies, 45,973 are not achieving good chemical status for 
mercury equating to about 41% of all surface water bodies in Europe11. If the widespread 
pollution  by  ubiquitous  priority  substances12,  including  mercury  (priority  hazardous 
substance), were omitted, the proportion of water bodies failing to achieve good chemical 
status would fall to 3% (as opposed to 46% for all such ubiquitous priority substances).  

According to the EEA State of Water Report, atmospheric deposition of mercury leads 
to contamination of over 45,000 water bodies that fail to achieve good chemical status, 
while  releases  from  urban  wastewater  treatment  plants  (UWWTP)  lead  to 
contamination  with  mercury  and  other  heavy  metals13  of  over  13,000  water  bodies. 
Whilst  dental  amalgam  appears  to  be  the  main  contributor  to  releases  of  mercury  from 
UWWTP to water bodies, it must be noted that inputs from UWWTPs constitute a less 
significant  factor  in  achieving  good  environmental  status  of  water  than  atmospheric 
depositions14.  Currently,  atmospheric  deposition  affects  38%  of  surface  water  bodies, 
with mercury being the main pollutant responsible for failure to achieve good chemical 
status15. The EEA State of the Environment Report states that diffuse pollution remains a 
problem  in  Europe  due  to  both  historical  and  current  emissions  of  mercury  to  the 
atmosphere and subsequently surface waters16. 

Mercury in soil and groundwater 

10 EEA (2018) European waters. Assessment of status and pressures 2018. Report No 7/2018 
11 European Commission (2019). COMMISSION STAFF WORKING DOCUMENT European Overview 

– River Basin Management  Plans. SWD(2019) 30 final, February 2019 

12 Other ubiquitous, persistent, bioaccumulative and toxic substances causing failure to meet good chemical 
status  next  to  mercury  are  pBDEs,  tributyltin  and  certain  polycyclic  aromatic  hydrocarbons 
(benzo(a)pyrene, 
and 
benzo(k)fluoranthene).  Mercury  is  the  most  common.  Out  of  some    111  000  European  water  bodies 
identified  in  an  EEA  report  No  18/2018,  more  than  45  000,  across  24  Member  States,  are  failing  to 
reach good chemical status due to mercury pollution 

indeno(1.2.3-cd)pyrene, 

benzo(b)fluoranthene 

benzo(g,h,i)perylene, 

13 EEA (2018) European waters. Assessment of status and pressures 2018. Report No 7/2018 
14  European  Commission  (2016),  Commission  Staff  Working  Document  Impact  Assessment  Ratification 

and Implementation by the EU of the Minamata Convention on Mercury 

15  COMMISSION  STAFF  WORKING  DOCUMENT  EVALUATION  of  the  Council  Directive 

91/271/EEC of 21 May 1991, concerning urban waste-water treatment, available at:  

https://ec.europa.eu/environment/water/water-urbanwaste/pdf/UWWTD%20Evaluation%20SWD%20448-

701%20web.pdf  

16 

EEA 

(2020), 

State 

of 

the 

Environment 

reporting 

2020, 

available 

at: 

https://forum.eionet.europa.eu/nrcstate-environment/library/soer-2020-working-place-eionet/external-
review-of-the-soer2020/4.4.-keytrends-europe-and-european-countries-including-outlooks  

152 

 
 
                                                           
 
Climate change has a negative effect on mercury content in soil, through intensification 
of  various  phenomena,  e.g.,  increased  floods  can  lead  to  mercury  releases  through 
erosion  and  sediment  fluxes,  while  increased  rainfall  will  cause  higher  deposition  of 
mercury from the atmosphere. Mercury accumulated in trees and forest litter is released 
during forest fires caused by increasingly occurring draughts causing higher emissions to 
air. In addition, mercury contained in permafrost is predicted to be released to the oceans, 
as this is expected to thaw over the coming centuries. Once mercury is deposited on land, 
it can enter  the food chain,  especially through  food grown in  water environments  (e.g., 
rice).  Deposited  mercury  has  a  long  lifetime,  especially  when  transformed  into 
methylmercury,  which  can  persist  in  soils  for  decades17.  The  anthropogenic  mercury 
contamination  in  soil  and  groundwater  may  result  in  much  higher  concentrations 
compared  to  other  environmental  media,  particularly  in  contaminated  sites18.  Unlike  in 
water  bodies,  where  mercury  tends  to  accumulate  over  time,  in  soils,  mercury  tends  to 
accumulate  until  an  event  (e.g.,  erosion,  floods  and  forest  fires)  causes  its  release. 
Globally,  it  is  estimated  that  there  are  approximately  10,000  tonnes  of  mercury  in 
vegetation, 863,000 t in the active layer of the soil, 793,000 t in permafrost and 454,000 
tonnes in other types of soil19. In EU, the estimated mercury stocks in topsoil (0-20cm) is 
about  45,000  tonnes20  according  to  the  topsoils  Land  Use/Land  Cover  Area  Frame 
Survey  (LUCAS)  survey21.  High  values  of  Hg  are  measured  especially  close  to  past 
mining  activities,  chlor-alkali  industries  and  coal  combustion  sites.  The  level  of  local 
mercury contamination in the EU also depends on past or present local diffuse pollution 
activities  such  as  small-scale  industries  employing  mercury  (scientific  instruments, 
electrical  equipment,  dental  amalgam,  felt  making,  disinfectants,  and  production  of 
caustic soda). 

Movement of mercury 

Mercury is a global pollutant, as airborne mercury can be transported over long distances 
(i.e.,  across  continents)  depending  on  the  speciation  of  mercury  emissions  and  reaction 
pathways,  before  being  deposited  on  the  Earth’s  surface.  Across  different  areas  of  the 
EU, the origin of atmospheric mercury deposition can differ substantially22. Currently it 
is  estimated  that  European  emissions  contribute  up  to  60%  in  certain  areas,  while  in 
others (e.g., the Mediterranean), the atmospheric deposition originating from sources in 
Europe  corresponds  to  only  20%  or  less  of  the  total  deposition.  This  significant 
transboundary  component  of  mercury  indicates  that  addressing  the  problem  requires 
action at the global level together with measures implemented at EU level. Despite this 
transboundary  nature  of  mercury,  in  the  last  two  decades  only  the  EU  and  a  few  other 
countries  (e.g.,  Norway,  Switzerland,  the  USA,  Canada  and  Japan)  have  implemented 

17 EEA (2018) European waters. Assessment of status and pressures 2018. Report No 7/2018 
18 UNEP (2019), Technical information report on mercury monitoring in soil, available at:  
https://wedocs.unep.org/bitstream/handle/20.500.11822/30818/Soil_report.pdf?sequence=1&isAllowed=y  
19 UNEP (2019), Technical information report on mercury monitoring in soil, available at:  
https://wedocs.unep.org/bitstream/handle/20.500.11822/30818/Soil_report.pdf?sequence=1&isAllowed=y  
20  Ballabio  et  al.  (2021),  A  spatial  assessment  of  mercury  content  in  the  European  Union  topsoil 
https://www.sciencedirect.com/science/article/pii/S0048969720382887 
21    Orgiazzi  et  al.  (2018),  LUCAS  Soil,  the  largest  expandable  soil  dataset  for  Europe:  a  review  
https://bsssjournals.onlinelibrary.wiley.com/doi/10.1111/ejss.12499 
22  European  Commission  (2016),  Commission  Staff  Working  Document  Impact  Assessment  Ratification 

and Implementation by the EU of the Minamata Convention on Mercury  

153 

 
 
                                                           
restrictions  and  other  measures  that  aim  to  decrease  or  cease  the  use  of  mercury  and 
eventually the contribution to the global pool of mercury. In fact, in several countries in 
Asia the exact opposite trend has been observed with increases of mercury pollution in 
several  Asian  countries  due  to  their  industrialisation23.  Mercury  can  be  displaced  from 
topsoils with water erosion and runoff and transferred with sediments to river basins and 
eventually released to coastal Oceans. On average, around 6 tonnes of Hg may end in the 
EU rivers and released to costal oceans due to water erosion24. 

Figure 1: The global mercury cycle 

Prod-ID:  INF-90-enPublished  27  Sep  2018  (https://www.eea.europa.eu/media/infographics/the-global-mercury-
cycle/view)  

Properties 

Mercury,  an  elemental  heavy  metal,  is  a  persistent  pollutant  and  a  toxic  compound  for 
humans  and  the  environment,  which  exists  in  different  forms  on  earth  (elemental, 
inorganic  and  organic).  Under  anaerobic  conditions,  in  soil  or  water,  bacteria  can 
metabolise  inorganic  mercury  to  a  highly  potent  neurotoxin,  methylmercury.  In 
contaminated  ecosystems,  methylmercury  can  enter  organisms,  especially  plants  and 
predatory fish that are tolerant to a high amount of mercury.  

Source 

23  European  Commission  (2016),  Commission  Staff  Working  Document  Impact  Assessment  Ratification 

and Implementation by the EU of the Minamata Convention on Mercury 

24  Panagos  et  al  (2021)  Mercury  in  European  topsoils:  Anthropogenic  sources,  stocks  and  fluxes. 
https://www.sciencedirect.com/science/article/pii/S0013935121008501 

154 

 
 
 
 
                                                           
Mercury is a global pollutant, as airborne mercury can be transported over long distances 
(i.e. across continents) before being deposited on the Earth’s surface. Mercury emissions 
are distributed in all environmental media including air, water and soil and affect human 
health, fauna and flora. 

Human health 

The release of mercury from anthropogenic sources, including dental amalgam, induces a 
progressive  increase  in  the  amount  of  mercury  in  the  environment.  Mercury,  as  a 
persistent substance which can enter the water cycle. Under anaerobic conditions, in soil 
or  water,  bacteria  can  metabolise  inorganic  mercury  to  a  highly  potent  neurotoxin, 
methylmercury.  

In  contaminated  ecosystems,  methylmercury  can  then  bioaccumulate  in  organisms, 
especially  plants  and  fish  that  are  tolerant  to  a  high  amount  of  mercury.  Levels  of 
mercury  in  fish  vary  by  species  and  their  environment.  Methylmercury  introduced  into 
the food chain via plants or fish can be ingested by humans.  

The mercury  concentrations in  organisms, including humans are  affected by  two major 
amplification  processes:  bioaccumulation  that  refers  to  the  increase  of  mercury 
concentrations along the lifetime of an individual and biomagnification that is defined as 
the  increment  of  mercury  concentration  between  the  successive  consumer  levels  of  the 
food  chain25.  In  humans,  these  processes  can  lead  to  toxic  effects  (nervous  system 
damage in adults and neurological development damages in infants)26.  

Minamata Accident 

Between  1932  and  1968,  a  devastating  incident  occurred  in  the  city  of  Minamata, 
Kumamoto  Prefecture,  Japan,  whereby  a  large  amount  of  mercury  was  released  by  a 
petrochemical  factory  directly  into  the  Minamata  Bay  via  industrial  wastewater.      The 
released  mercury  subsequently  converted  into  methylmercury,  contaminating  shellfish 
and fish. The contaminated seafood was consumed by the local population of Minamata, 
leading  to  mercury  poisoning  and  significant  and  lasting  impacts  on  their  health. 
Specifically,  the  poisoning  affected  the  central  nervous  system.  This  effect  was  named 
the  Minamata  disease.  It’s  signs  and  symptoms  include ataxia, numbness in  the  hands 
and 
feet,  general muscle  weakness, loss  of  peripheral  vision,  and  damage 
to hearing and speech.  In  extreme  cases, coma  and death follow  within  weeks  of  the 
onset  of  symptoms.  This  unprecedented  incident  led  to  an  increased  awareness  of  the 
risks  of  exposure  to  mercury  and  particularly  the  effect  of  methylmercury  on  human 
health. 

Environmental health 

Mercury emitted to the atmosphere, travels through the air and is eventually deposited to 
soil and water bodies. Current global levels of mercury in the atmosphere are about 500% 

25 Pouilly M. et al (2013), Trophic Structure and Mercury Biomagnification in Tropical Fish Assemblages, 

Iténez River, Bolivia, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0065054 

26  According  to  the  US  Agency  for  Toxic  Substances  and  Disease  Registry  (ATSDR)  when  mercury  is 
swallowed, only a small amount (less than 0.01%) will be absorbed by the body unless the stomach or 
intestines, are diseased. However, when mercury is breathed most (about 80%) of the mercury enter the 
bloodstream  directly  from  your  lungs,  and  moves  to  other  parts  of  the  body,  including  the  brain  and 
kidneys where it can be accumulated for weeks or months. 

155 

 
 
                                                           
above natural levels resulting from anthropogenic activities and around 40% of the EU’s 
surface  water  bodies  are  currently  assessed  as  contaminated  with  dangerous  levels  of 
mercury27. 

2.  Problem drivers 

2.1 Dental amalgam and associated emissions from crematoria 

Dental  amalgam  is  the  biggest  source  of  intentionally  used  mercury  in  the  EU,  and 
despite its use steadily decreasing, it is expected to still be in use in the EU in 2030 if no 
action  is  taken.  Mercury  from  dental  amalgam  is  released  into  the  environment  (soil, 
atmosphere,  water)  via  dental  practices  (surplus  of  amalgam  or  tooth  extraction); 
deterioration  in  the  mouth;  burial  or  cremation;  and  waste  management.  The  overall 
problem tree for dental amalgam is presented below. 

Figure 2: Overall problem tree for dental amalgam 

2.2 Mercury emissions from crematoria 

Recognising the transboundary nature of mercury pollution, crematoria are an important 
source of mercury emissions in the EU which are expected to follow the general trends of 
dental  amalgam  use.  The  OSPAR  and  Helsinki  (HELCOM)  Commissions  recommend 
the  use  of  Best  Available  Techniques  (BAT)  to  address  mercury  emissions  from 
crematoria  but,  with  only  11  and  8  EU  Member  States  signatories  to  the  Conventions 
respectively,  the  level  of  action  on  crematoria  emissions  varies  across  Europe.  The 
overall problem tree for crematoria is presented below. 

27 EEA (2018) European waters. Assessment of status and pressures 2018. Report No 7/2018 

156 

 
 
 
 
 
                                                           
Figure 3: Overall problem tree for mercury emissions from crematoria 

2.3 Mercury-added products 

Some mercury-added products (MAPs) although already banned for sale within the EU 
are  still  allowed  for  manufacture  and  export  to  third  countries.  This  situation  causes 
continuing demand for mercury within the EU, sustains supply for MAPs and contributes 
to mercury releases in importing countries.  

Due to its unique physical and chemical properties, mercury has historically been used in 
a  wide  range  of  products.  Concerns  about  its  environmental  and  health  risks  pushed 
manufacturers and legislators to develop and promote effective mercury-free alternatives 
and  to  restrict  or  ban  the  manufacture,  sell  and  trade  of  mercury-added  products.  Most 
known MAPs are no longer allowed to be placed on the European market. The European 
Mercury Regulation also bans the export of a range of products, but it mainly limits the 
scope  of  trade  restrictions  to  those  products  that  are  addressed  by  the  Minamata 
Convention.  Consequently,  export  is  still  allowed  for  numerous  products  that  are 
prohibited for sale within the EU.  

Products that contain a hazardous substance such as mercury pose a risk to human health 
and  the  environment  during  use  and  disposal.  Stopping  the  manufacture  and  export  of 
such products for which effective, affordable, and safer alternatives already exist, would 
further decrease EU internal demand for mercury, reduce the supply of MAPs to non-EU 
countries  and  may  contribute  to  lower  mercury  emissions  and  releases.  For  some 
products such as lamps reduction of supply may also be an incentive to switch to more 
energy-efficient lamp types such as LEDs, leading to lower CO2 emissions and contribute 
to achieving climate change goals.  

The overall problem tree for mercury-added products is presented below. 

157 

 
 
 
 
Figure 4: Overall problem tree for mercury-added products 

158 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annex 7: Impacts of shortlisted measures 

CONTENTS 

Problem Area 1: Dental Amalgam ...................................................................................... 157 
Measure DA#1: Establish a legally binding end date for the use of dental amalgam in the 
EU by: DA#1a (2025) DA#1b (2027) or DA#1c (2030)..................................................... 157 

Measure  DA#2:  Communication  campaign  to  raise  awareness  and  change  behaviour  of 
dental patients (and practitioners) towards mercury-free dental filling alternatives ........... 174 

Measure  DA#3:  Raise  prices  of  dental  amalgam  reflecting  risks  due to  mercury  exposure

176 

Problem Area 2: Mercury emissions from crematoria ........................................................ 179 
Measure CRE#1a: Issue EU guidance on emissions abatement in crematoria ................. 179 

Measure CRE#1b: Issue EU guidance accompanied by voluntary agreements for the sector

184 

Measure CRE#2: Define Best Available Techniques (BAT) / Associated Emissions Levels 
(AELs)  188 

Measure CRE#3: Mercury benchmarks/reduction targets ................................................. 194 

Measure CRE#4: Burden sharing agreements ................................................................... 195 

Measure CRE#5: National mercury reduction targets ....................................................... 199 

Problem Area 3: Manufacture of MAPs for export to third countries ................................. 201 
Measure  MAP#1:  Aim  at  global  agreement  to  restrict  manufacture  and  export  and 
subsequent implementation in EU law ................................................................................ 201 

Measure MAP#2(a and b): EU legal ban on MAP manufacture and export .................... 207 

Measure  MAP#2c:  EU  legal  ban  on  MAP  manufacture  and  export  and  administrative 
/scientific support for importing third countries .................................................................. 212 

Measure MAP#3: Prior Informed Consent (PIC) procedure for dental amalgam ............. 214 

Discarded policy measures and rationale ............................................................................ 215 

159 

 
 
 
 
 
 
 
Problem Area 1: Dental Amalgam 
There are three measures shortlisted to address the use of dental amalgam in the EU: 

  DA#1: Establish legally binding end date for the use of dental amalgam in the EU 

(sub-options with different end dates) 

  DA#2:  Communication  campaigns  to  raise  awareness  and  change  of  dental 
patients (and practitioners) towards mercury-free dental filling alternatives 

  DA#3: Raise prices of dental amalgam reflecting risks due to mercury exposure 

The measures considered are a combination of hard measures (DA#1 mandatory phase-
out  with  different  deadlines  with  respective  sub-options)  and  soft  measures  (DA#2 
awareness  raising  and  DA#3  reducing  the  financial  burden  on  citizens  for  getting 
treatment using amalgam alternatives). The phase-out measures consider 2025 (DA#1a), 
2027  (DA#1b)  and  2030  (DA#1c)  as  the  deadlines.  We  assume  that  the  legislative 
proposal on a decision on the phase-out date will be adopted most probably in 2024. 

The  three  sub-options  DA#1a,  DA#1b  and  DA#1c  will  lead  to  an  almost  complete 
cessation of mercury releases associated with the placement of new fillings, which will 
occur by 2025, 2027 or 2030, with DA#1a and b leading to a particularly steep decline in 
use  of  dental  amalgam.  Once  the  decision  is  taken,  a  significant  decrease  in  dental 
amalgam  use  is  expected  to  occur,  as  the  main  actors  (amalgam  manufacturers  and 
dentists) will tend to anticipate the change in policy. Also, the communication on phase-
out  plans  will  increase  awareness  on  the  environmental  problems  caused  by  dental 
amalgam among patients, making dental amalgam a less favoured material.  

The  overall  assessment  of  impacts  builds  on  the  baseline  model  developed  to  estimate 
amalgam use currently and up to 2030.  

The  policy  measures  were  shortlisted  to  address  the  identified  problems  and 
shortcomings and to achieve a set of objectives. The objectives are:    

1.  Establish  the  phase-out  of  dental  amalgam  in  the  EU  whilst  ensuring  access  to 

oral health care including affordable mercury-free alternatives 

2.  Reduce  emissions  from  crematoria  to  reduce  pollution  to  levels  not  considered 

significant to human health and the environment 

Each measure has been assessed individually, covering a more in-depth description of the 
measure,  an  outline  of  the  requirements  for  implementation  and  an  assessment  of  their 
economic, environmental, and social impacts supported by evidence. 

Measure  DA#1:  Establish  a  legally  binding  end  date  for  the  use  of  dental 
amalgam in the EU by: DA#1a (2025) DA#1b (2027) or DA#1c (2030) 

Environmental impacts 

When the phase-out starts to apply through DA#1a assuming that it will be announced in 
2024,  there  will  be  a  sudden  drop  to  zero  in  2025.  In  the  two  other  two  sub-options 
(DA#1b and DA#1c), a significant immediate decrease can be expected in mercury use 
compared to the baseline and then at a slower rate as shown in Figure 1 below. However, 
small amounts of mercury may still be used to treat specific medical conditions. For the 

160 

 
 
phase-out scenario in 2027 (DA#1b) and 2030 (DA#1c), a polynomial trend is used for 
estimating  the  trends.  Assuming  a  proportionate  decline  in  amalgam  shares  in  total 
treatments distributed over the period until the phase-out, the decline of mercury content 
is much steeper than the baseline. The following figure shows both the data point and the 
polynomial fit curves (dotted curves). 

Figure 1: Phase-out of mercury based on policy measures 

Table 1 provides estimates on the mean mercury use and Table 2 on the number of dental 
amalgam treatments for specific years. Dental amalgam usage is assumed to be zero from 
the  specified  phase  out  date  although,  in  practice,  it  is  expected  that  there  may  still  be 
some low levels of usages for specific cases, exemptions etc. (if allowed for).  

Table  1:  Mean  mercury  use  for  specific  years  (includes  both  in  teeth  and  wasted)  (EU 
average, tonnes) 

Policy 
option 

DA#1a 

DA#1b 

DA#1c 

2024 

2025 

2026 

2027 

2028 

2029 

2030 

21.9 

21.9 

21.9 

0 

14.3 

17.8 

0 

4.8 

11.9 

0 

0 

5.9 

0 

0 

2.0 

0 

0 

0.3 

0 

0 

0 

Table 2: Number of dental amalgam treatments (million) for specific years  

2024 

2025 

2026 

2027 

2028 

2029 

2030 

EU 
Average 
Projected 

161 

 
 
 
 
DA#1a 

DA#1b 

DA#1c 

37.3  

37.3 

37.3 

0 

16.8 

20.9 

0 

8.1 

20.2 

0 

0 

7 

0 

0 

3.4 

0 

0 

0.6 

0 

0 

0 

A  phase-out  of  dental  amalgam  would  lead  to  a  sudden  drop  to  zero  of  its  use  in  the 
deadline year. Small amounts of mercury may however still be used to treat patients with 
specific medical conditions.  

Mercury used in dental amalgam restorations is released to the air, soil and water via a 
number of pathways. Previous assessment indicated that approximately 1% of mercury in 
used  and  waste  dental  amalgam  in  dental  practices  is  released  to  air  as  restorations  are 
created1.  Use  of  amalgam  separators  (which  are  required  to  remove  95%  of  amalgam 
particles  in  accordance  with  Article  10  of  the  Mercury  Regulation)  in  dental  practices 
results in the formation of solid waste and sludge, of which 85% is treated as hazardous 
waste, 10% is  treated as non-hazardous waste, and 5% is treated as biomedical  waste1. 
An estimated 1% of mercury in hazardous waste, 29% in non-hazardous waste, and 25% 
in biomedical waste is estimated to be released to air1.  

Dental  amalgam  use  (including  wasted  amalgam)  in  2019  and  2030  (as  part  of  the 
baseline) as well as their estimated emissions are presented in Table 3 below. 

Table 3: Total dental amalgam inputs and outputs (2019 and 2030) 

Fate  of  Dental  Amalgam 
(DA) 

Total DA Inputs 

Total DA 

DA used in restorations 

DA to waste 

TOTAL DA OUTPUTS 

Emissions to air 

Emissions to water2 

Discharged to wastewater3 

Emissions to soil 

Sequestered or recycled 

T of Hg per year (2019) 

T of Hg per year (2030) 

40.4 

18.6 

21.6 

1.3 

0.3 

1.1 

1.4 

17.8 

11.2 

5.2 

6.0 

0.4 

0.1 

0.3 

0.4 

4.9 

Any mercury used in dental amalgam will, in the short, medium or long-term, enter the 
environment via various pathways (see Figure 2). 

1  Deloitte,  INERIS  &  Wood  (2020)  Assessment  of  the  feasibility  of  phasing-out  dental  amalgam. 

https://circabc.europa.eu/sd/a/4fd46a0f-54aa-48c6-8483-
288ad3c1c281/Dental%20Amalgam%20feasbility%20study%20-%20Final%20Report.pdf 

2 Refers to discharges direct to the aquatic environment. 
3 Refers to discharges to wastewater streams, ultimately reaching wastewater treatment plants. 

162 

 
 
 
 
                                                           
Figure 2: Fate of mercury and flows into the environment resulting from dental amalgam 
use (2019) 

Additionally,  the  releases  of  mercury  to  the  environment  in  2019  as  a  result  of  dental 
amalgam  in  deceased  people’  mouths  are  displayed  in  Figure  3.  These  emissions  are 
displayed separately from the releases from dental use, as the former account for legacy 
mercury (i.e., mercury in dental amalgam restorations fitted in patients’ teeth in 2019 as 
well as previous years), while the latter only account for releases in  2019 (i.e., mercury 
used in restorations fitted in patients’ teeth in 2019 only). 

163 

 
 
 
Figure 3: Fate of mercury and flows into the environment resulting from dental amalgam in 
deceased people (2019) 

The  three  phase-out  scenarios  assessed  within  this  Policy  Option  would  reduce  these 
environmental releases to zero as the underlying source, continued dental amalgam use, 
is eliminated, except in the few cases where such a use will remain justified to address 
specific  medical  conditions.  However,  there  would  be  a  time  lag  for  releases  to  the 
environment via cremations and burial to drop to zero due to the legacy issue associated 
with  dental amalgam i.e. the dental  amalgam  already in  teeth  in  the  general  population 
will gradually be replaced over time.  

The cumulative reductions in mercury used in dental restorations up until the year 2035 
are given below for each of the three phase-out scenarios: 

  DA#1a (2025 phase-out): a reduction in mercury use of 114.4 t by 2035 
  DA#1b (2027 phase-out): a reduction in mercury use of 75.9 t by 2035 
  DA#1c (2030 phase-out): a reduction in mercury use of 29.8 t by 2035 

Previous assessment estimated the total mass of mercury in people’s mouths in the EU-
27 (excluding Croatia but including the UK) at over 1,000 tonnes4. The total population 
mercury load will be declining as a result of existing actions taken by the Member States 
to  eliminate  or  reduce  the  use  of  dental  amalgam.  The  phase-out  scenarios  would 
facilitate a quicker reduction in the population mercury load, although it is not possible to 
reliably quantify this change in reduction. 

4 European Commission (2012). Study on the potential for reducing mercury pollution from dental 
amalgam and batteries: Final report. 
https://ec.europa.eu/environment/chemicals/mercury/pdf/mercury_dental_report.pdf 

164 

 
 
 
 
                                                           
 
The cumulative reductions in environmental releases of mercury up until the year 2030 
resulting from the phase-out scenarios, considering the mass flows set out in Figure 2, are 
displayed in Table 4.  

Table  4:  Cumulative  reductions  in  environmental  mercury  releases  resulting  from  phase-
out scenarios  

Fate  of  Dental  Amalgam 
(DA) 

T of Hg (DA#1a 2025 
phase-out) 

T of Hg (DA#1b 2027 
phase-out) 

T of Hg (DA#1c 2030 
phase-out) 

Emissions to air 

Emissions to water5 

Discharged to wastewater6 

Emissions to soil 

Sequestered or recycled 

3.1 

0.6 

2.6 

3.4 

42.1 

1.3 

0.3 

1.1 

1.4 

17.9 

0.4 

0.1 

0.3 

0.4 

4.9 

In  addition,  a  phase-out  of  dental  amalgam  would  result  in  indirect  environmental 
benefits  through  reduced  mercury  emissions  from  crematoria,  although  the  continued 
arrival of mercury to crematoria in ‘legacy’ restorations means that emissions reductions 
would be delayed and would not follow dental amalgam use in immediately dropping to 
zero.  Relative  to  a  baseline  assuming  no  EU-level  phase-out  of  dental  amalgam,  the 
phase-out  scenarios  are  anticipated  to  have  the  following  impacts  in  terms  of  mercury 
emissions to air from crematoria in 2030 (relative to baseline emissions of 355 kg). The 
below figures represent a snapshot of changes in emissions in 2030, and not cumulative 
emissions  savings  over  a  set  period  of  time.  They  take  account  of  emissions  from 
‘legacy’ amalgam in old dental restorations, hence continued crematoria emissions even 
after  the  phase-out  of  dental  amalgam.  The  figures  highlight  that  an  earlier  dental 
amalgam phase-out would deliver much greater crematoria emissions reductions sooner 
(both in 2030 and cumulatively from the date of a ban). 

  2025 phase-out: a reduction in mercury emissions of 54 kg in 2030 

  2027 phase-out: a reduction in mercury emissions of 31 kg in 2030 

  2030 phase-out: a reduction in mercury emissions of 3 kg in 2030 

Even  if  the  use  of  mercury  is  reduced  or  phased  out  entirely  under  these  scenarios,  its 
release  into  the  environment  will  continue  as  a  result  of  old  amalgam  fillings  through 
crematoria  as  well  as  through  corrosion  of  fillings,  not  properly  working  amalgam 
separators, disposal of amalgam in general waste and subsequent disposal/ incineration. 
Aside  from  emissions  from  crematoria,  emissions  will  arise  from  the  removal  of  old 
dental  amalgam  restorations  at  the  end  of  their  service  life,  and  their  disposal.  Sources 
indicate  that  the  typical  lifespan  of  a  dental  amalgam  restoration  is  approximately  15 
years7, indicating that environmental impacts will persist for some time after a phase-out. 

5 Refers to discharges direct to the aquatic environment. 
6 Refers to discharges to wastewater streams, ultimately reaching wastewater treatment plants. 
7  Kirsch  et  al.,  (2016).  Decision  criteria  for  replacement  of  fillings:  a  retrospective  study. 

https://onlinelibrary.wiley.com/doi/10.1002/cre2.30  

165 

 
 
 
 
                                                           
This  will  result  in  releases  to  air,  soil  and  water  via  the  same  pathways  as  discussed 
above, but it is not possible to reliably quantify these emissions. Even after a complete 
phase-out, some mercury could still continue reaching crematoria, e.g.:  

  Some  fillings  exceed  the  average  lifetime.  A  filling  obtained  in 
adolescence  may  remain  in  the  mouth  until  the  person  dies  of  natural 
causes.) 

  Expatriated  EU  citizens  and  immigrants  to  the  EU  who  could  have 
amalgam fillings done in a country outside the EU., and because of  

  Specific cremation  practices,  e.g., in  Italy where the cremation  can take 

place several years after the burial.  

Social impacts 

It  is  expected  that  new  jobs  will  be  created  to  train  the  dentists  who  did  not  receive 
training for using alternatives or haven’t practiced it much, some of which will need to 
improve their skills or acquire new skills in mercury-free restoration techniques within a 
short  timeframe.  New  jobs  would  also  be  expected  to  support  R&D  activities  in  the 
dental  fillings  industry  due  to  the  need  for  companies  to  maintain  a  high  level  of 
innovation in mercury-free materials. 

A  phase-out  of  dental  amalgam  is  expected  to  have  both  direct  and  indirect  health 
benefits for EU society. Benefits will be observed for the general population as mercury 
exposure  reduction  will  lead  to  lower  mercury  levels  in  the  blood,  and  reduction  of 
associated  health  risks,  which  could  range  from  neurological  and  cardiovascular  to  the 
immune system. In particular, the greatest direct benefits will be for dental practitioners 
as they are directly exposed to mercury vapours and the mercury body burden of dental 
personnel is usually higher than in the general population8. These benefits are expected to 
be higher under DA#1b as the exposure will cease sooner. The reduction of releases to 
water (e.g., via deposition from the atmosphere and emissions from crematoria) is likely 
to  reduce  mercury  content  in  the  marine  food  chain  and,  ultimately  in  fish,  which  is 
directly linked to human exposure to mercury.  

Regarding  potentially  avoided  indirect  health  damages,  the  phase-out  would  result  in 
reduced  emissions  from  crematoria.  The  crematoria  workers  may  still  be  exposed  to 
mercury  vapours  from  the  effluents  and  solid  mercury-containing  waste  if  no  adequate 
protection measures are in place, but this exposure should strongly decrease 10-15 years 
after the phase-out the fully effective. However, some emissions could still occur through 
corrosion of fillings, not properly working amalgam separators, disposal of amalgam in 
general waste and subsequent disposal/ incineration. 

It  would  also  reduce  the  exposure  of  the  personnel  working  in  hazardous  waste 
management  (from  amalgam  separators).  However,  this  benefit  would  be  rather  in  the 
long  term  as  the  removal  of  existing  teeth  with  amalgam  still  need  to  be  collected  and 
treated as well as in the case of patients with special health needs where dental amalgam 
would  still  be  used.  These  benefits  are  expected  to  be  higher  under  DA#1a  as  the 
exposure will cease sooner. The reduction of releases to water (e.g., via deposition from 

8     SCENIHR (2015) Opinion on the safety of dental amalgam and alternative dental restoration materials 

for patients and users 

166 

 
 
                                                           
the atmosphere and emissions from crematoria) is likely to reduce mercury content in the 
marine food chain and, ultimately in fish, which is directly linked to human exposure to 
mercury. 

The  reductions  in  mercury  emissions  from  crematoria  in  2030  outlined  in  the  previous 
section are estimated to result in the following human health benefits, valued using EEA 
damage cost functions: 

  DA#1a: human health benefits valued at €900,000 
  DA#1b: human health benefits valued at €500,000 
  DA#1c: human health benefits valued at €50,000 

Another  benefit  of  substituting  amalgam  with  mercury-free  filling  materials  such  as 
resin-based  composites  or  glass  ionomers  is  the  ability  to  preserve  a  healthier  tooth 
structure in patients, as these alternative materials have good adhesive properties and do 
not require to enlarge the cavity because amalgam needs to be mechanically linked to the 
remaining tooth structure. It must be noted that amalgam alternatives potentially can also 
have  health  impacts,  for  example,  allergic  reactions  and  possible  health  impacts  due  to 
the release of small quantities of endocrine-disrupting substances. This is the case for the 
risk  of  release  of  bisphenol  A,  a  recognized  endocrine  disruptor  and  classified  as  a 
category 2 carcinogen, mutagen, reprotoxic (CMR) for reproduction, i.e., "likely to harm 
fertility or the foetus", potentially observed after the application of composites, some of 
which are made from monomers derived from this compound, or the use of biomaterials 
containing  nanomaterials.  The  latter  requires  further  scientific  evidence  regarding  their 
safety.9  Furthermore,  it  should  be  noted  that  medical  device  manufacturers  are  still  not 
required to inform users about dental biomaterials and their full chemical composition. It 
is,  therefore,  impossible  to  be  sure  of  their  biocompatibility.  However,  alternatives  to 
Bis-GMA, Bis-EMA and Bis-DMA-based resins exist, such as Urethane DiMethAcrylate 
(UDMA) based resins10 and, more recently, alternative resins based on siloranes11 in place 
of methacrylates12. 

Economic impacts 

The  main  economic  impacts  of  the  phase-out  of  dental  amalgam  will  be  the  direct  and 
indirect  impacts  on  economic  actors,  citizens  and  public  authorities.  The  magnitude 
between  DA#1,  DA#1b  and  DA#1c  will  differ,  but  the  rationale  is  similar.  The  main 
actors  impacted  by  it  are  citizens,  amalgam  producers,  manufacturers  of  alternatives, 
dental clinics, and crematoria. 

Impacts on citizens  

9  CENIHR. The safety of the use of bisphenol A in medical devices. 2015 and Van Landuyt KL et al.  

Nanoparticle release from dental composites. Acta Biomater 2014  

10    https://substitution.ineris.fr/sites/substitution-

portail/files/newsletter/newslettersna_10_1216_v2b_gb_0.pdf   

11    Siloranes are a combination of siloxane and oxiranes. The silorane composites generate lower volume 

shrinkage and stress upon polymerization. 

12    SCENIHR, 2015. Scientific opinion on the Safety of Dental Amalgam and Alternative Dental 

Restoration Materials for Patients and 
Users.(https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_046.pdf) 

167 

 
 
                                                           
Currently,  the  use  of  dental  amalgam  affects  EU  citizens  mainly  through  their  tax 
contributions  to  the  costs  of  managing  mercury-contaminated  urban  wastewater  and 
municipal waste (usually included in local taxes). If the installation of separators has not 
already led to sufficiently low levels of mercury in sewage sludge, an amalgam phase-out 
would  ultimately  (in  the  long-term)  result  in  an  even  lower  input  of  mercury  into  the 
wastewater system. Overall, this will have a positive economic impact on municipalities 
and  taxpayers,  as  it  will  reduce  the  environmental  costs  associated  with  managing 
mercury pollution from dental amalgam. 

The  main  economic  aspect  for  dental  patients  is  the  cost  of  dental  restorations  using 
alternatives.  In  scenario  DA#1a,  the  change  will  be  abrupt  and  the  cost  impact  will  be 
high  in  the  short  run.  In  scenarios  DA#1b  and  DA#1c,  the  expected  gradual  change  in 
dental  filling  materials  will  affect  the  costs  incurred  by  dentists  for  performing  the 
restorations, and it can be assumed that any changes in such costs will be fully passed on 
to  dental  patients.  Dental  restoration  costs  borne  by  the  patients  depend  on  four  main 
factors:  cost of the filling material, labour cost for the treatment,  reimbursement by the 
social security and/or private medical insurance, and the longevity of restorations. 

Under DA#1a and b, the substitution of dental amalgam  with  mercury-free restorations 
will be faster than under DA#1c. Given the currently higher labour cost of composite or 
glass ionomer restorations (the material  costs are negligible), the phase-out  will lead to 
additional  costs  for  dental  patients  (and/or  private  health  insurance,  social  security 
systems) compared to the baseline. However, this effect is expected to be partly offset by 
a  decrease  in  the  cost  of  restorations  using  alternatives  in  the  mid-term  and  longer 
average lifetime of fillings as we have seen in Sweden. Increased competition within the 
dental  fillings  industry  and  technological  improvements  will  likely  lead  to  decreases  in 
material costs (though negligible). Improved dentists’ skills will lead to further, reduced 
average durations for carrying out mercury-free restorations due to and subsequently to a 
decrease in the labour costs of dental treatment.  

The use of mercury-free alternatives is expected to increase overall costs for treatment in 
most countries because of the cost of filling material (negligible), the labour cost for the 
treatment using amalgam alternatives, and the longevity of restorations. The overall cost 
estimates  are  very  sensitive  to  the  cost  differential  between  the  treatment  cost  using 
dental amalgam and alternatives. The amount of this cost differential varies considerably, 
and this information is not available for all Member States. Dental restoration costs borne 
by  the  patients  depend  on  four  main  factors,  i.e.  (i)  the  cost  of  the  filling  material 
(negligible  difference  between  dental  amalgam  and  alternatives),  (ii)  reimbursement  by 
the social security and/or private medical insurance, (iii) the longevity of restorations and 
(iv) labour cost for the treatment. The difference in cost of restorations  can vary across 
the EU (see Table 5 although the data is from 2018 and cost differentials are expected to 
have  further  narrowed  as  more  Member  States  phase  out  dental  amalgam  use  and 
experience with use of alternatives increases).  

Table 5: Price difference between dental amalgam and its alternatives per Member State 

Country 

AT 
BE 
BG 

Price per restoration 
(dental amalgam) 
(EUR) 
97.5 
52.5 
13.0 

Price per restoration 
(alternatives) (EUR) 

Price difference (EUR) 

97.5 
52.5 
13.1 

168 

0 
0 
0.1 

 
 
Country 

CY 
CZ 
DE 
DK 
EE 
ES 
FI 
FR 
EL 
HR 
HU 
IE 
IT 
LT 
LU 
LV 
MT 
NL 
PL 
PT 
RO 
SE 
SI 
SK 
UK 
EU 28 

Price per restoration 
(dental amalgam) 
(EUR) 
60.0 
19.2 
48.2 
54.2 
28.3 
46.1 
50.0 
40.0 
50 
23.0 
20.4 
50.0 
125.0 
19.9 
58.0 
15.0 
70.0 
45.0 
19.0 
33.7 
13.9 
N/A 
26.0 
22.7 
42.7 
40.8 

Price per restoration 
(alternatives) (EUR) 

Price difference (EUR) 

60.0 
19.3 
75.0 
60.6 
28.5 
46.1 
50.0 
40.0 
60 
23.2 
20.6 
51.5 
175.0 
20.0 
71.0 
25.0 
70.0 
67.3 
19.1 
33.7 
14.0 
105.0 
48.5 
22.9 
45.8 
50.5 

0 
0.1 
26.8 
6.4 
0.2 
0 
0 
0 
10 
0.2 
0.2 
1.5 
50 
0.1 
13 
10 
0 
22.3 
0.1 
0 
0.1 
N/A 
22.5 
0.2 
3.1 
9.7 

In  Denmark,  amalgam  use  in  dental  fillings  decreased  92%  in  10  years;  from  22%  in 
2007  to  1.7%  in  2017,  showing  a  long-term  experience  with  the  phase-out  and  a  cost 
difference  of  about  6  euros  per  filling.  This  figure  is  therefore  considered  most 
representative of the cost differential if a full EU phase-out were to be applied. Based on 
this  differential, the additional  annual  costs of using alternatives in  the first  year of the 
phase out of dental amalgam (i.e., 2025, 2027 or 2030) are estimated as follows.  

Table 6: Range of additional cost estimates for 2025, 2027 and 2030 (in million euros) 

Austria 
Belgium 
Bulgaria 
Croatia 
Cyprus 
Czechia 
Denmark 
Estonia 
Finland 
France 

2025 additional costs  
€9.1m 
€2.9m 
€2.3m 
€0 
€0  
€18m 
€0.4m  
€0m 
€0m  
€116.9m 

2027 additional costs  
€6.8m 
€2.2m 
€2m 
€0 
€0  
€13.9m 
€0.3m  
€0 
€0 
€98.3m 

2030 additional costs  
€5.9m  
€1.5m 
€1.5m 
€0 
€0 
€1m 
€0.3m 
€0 
€0 
€80.3m 

169 

 
 
 
 
2025 additional costs  
€23.6m  
Germany 
€1.1m 
Greece 
€3.1m 
Hungary 
€6.7m  
Ireland 
€0m 
Italy 
€1.1m  
Latvia 
Lithuania 
€0.6m 
Luxembourg  €0.1m  
Malta 
Netherlands 
Poland 
Portugal 
Romania 
Slovakia 
Slovenia 
Spain 
Sweden 
EU total 

€0m 
€0.3m  
€0 
€4.5m 
€2.9m 
€1.9m 
€11.2m 
€1m 
€0 
€208m  

2027 additional costs  
€18m 
€1m 
€2.5m 
€5.2m 
€0m 
€0.9m 
€0.6m  
€0 
€0 
€0.2m 
€0 
€4.5m 
€2.4m 
€1.5m 
€8.7m 
€1m 
€0 
€170m 

2030 additional costs  
€14.9m 
€0.7m 
€0.8m 
€0 
€0 
€0.8m 
€0.5m 
€0 
€0 
€0.2m 
€0 
€2.7m 
€1.5m 
€1.5m 
€0m 
€0m 
€0m 
€114m 

Considering the difference in the use of dental amalgam across the EU, the distribution of 
these  costs  will  affect  Member  States  differently.  The  share  of  the  dental  filling  cost 
covered by social security and the premium charged by the private medical insurance will 
also impact the magnitude of direct economic impacts on citizens. However, the share of 
these additional costs that will be borne by the patients depends on reimbursement by the 
social  security  and/or  private  medical  insurance.  Figure  4  provides  an  overview  of  the 
existing financing structures in the dental sectors of a number of Member States. FR and 
DE have the greatest share of public expenditure in their total dental expenditure (>60%), 
followed  by  HR,  BG,  LU  and  SK.  Dental  care  expenditure  in  EL,  ES  and  CY  is 
dominated by private financing, while voluntary health insurance schemes make up the 
majority (>60%) of expenditure in the NL.  

170 

 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 4: Government, voluntary and out-of-pocket spending for dental care as % of total 
dental outpatient curative care expenditure 

Data from the OECD Health Statistics 2022 database. Data for 2020, except for Denmark and the Netherlands (2021 
data), and Malta (2019 data). No data for Portugal, Italy or Ireland. 

In the  case of  DA#1a and b, the prices of mercury-free restorations  can  be expected to 
decrease  at  a faster pace because of the time  constraint (especially  where dentists have 
been  using  mostly  amalgam)  and  the  economy  of  scale  due  to  improved  skills  in 
mercury-free  restorations  and  innovation.  However,  it  can  be  assumed  that  private 
medical  insurance  companies  will  adapt  better  in  the  case  of  DA#1c  (and  possibly 
DA#1b) as the insurers will have more time to analyse the medical history of patients and 
their  dental  treatments  and  thus  define  the  insurance  premiums  adapted  to  real-life 
situations.  The  direct  impact  on  citizens  will  vary  significantly  across  Member  States 
because of different social security schemes and private health insurance. 

171 

 
 
 
The  short-term  economic  impact  of  the  phase-out  on  patients  will  depend  on  the 
proportion of the costs reimbursed by national health insurance schemes. Dental patients 
would therefore bear additional treatment costs, except in a few Member States where a 
higher  amount  is  reimbursed  for  mercury-free  restorations  (compared  with  amalgam 
restorations).  Also,  private  medical  insurance  may  increase  the  premium  to  cover  the 
increased cost.  

The  projected  increase  in  dental  restoration  costs  for  patients  is  expected  to  affect  the 
private health insurance industry positively, as it will increase the demand for insurance 
services covering dental treatment. 

The possible deterioration of dental health in  disadvantaged communities due to  higher 
treatment costs if more expensive restoration techniques are used has been raised as an 
important issue by the Council of European Dentists (CED). The CED reports that, while 
dental decay rates are falling in developed countries, approximately 80% of oral diseases 
can be found in 20% of the population, usually disadvantaged communities13. However, 
the  Swedish  experience  with  the  phase-out  of  dental  amalgam  shows  that  no  adverse 
clinical effects have been observed in the Swedish population following the adoption of 
the ban. In fact, the possible adverse public health effects due to reduced affordability of 
dental treatment depend very much on the public health policy of the Member State, i.e., 
whether  there  are  effective  dental  decay  prevention  programmes  in  place  and  whether 
dental  care  is  subsidised  for  the  most  vulnerable  and  disadvantaged  categories  of  the 
population.  

It  is  also  important  that  possible  adverse  health  effects  due  to  reduced  affordability  of 
dental  treatment  for  disadvantaged  citizens,  and  public  spending  to  ensure  affordability 
of dental care, are put in perspective with the currently high environmental and indirect 
health  impacts  and  costs  of  mercury  pollution  caused  by  dental  amalgam  use,  and  the 
benefits associated with a reduction of these impacts for the society at large.  

Impacts on dental filling industry 

The  phase-out  measures  will  put  significant  pressure  on  dental  fillings  manufacturers 
with  a  high  share  of  dental  amalgam  in  their  overall  production.  On  the  other  hand, 
companies  with  a  high  share  of  mercury-free  materials  in  their  production  will  gain  an 
even more significant competitive advantage. 

Overall,  since  the  present  study  identified  only  four  main  EU  companies  producing 
encapsuled  dental  amalgam,  the  economic  impact  on  the  dental  industry  is  expected  to 
remain limited. According to the observed global trends, demand for dental amalgam and 
exports  from  the  EU  are  likely  to  decrease.  An  EU  export  ban  from  the  EU  would 
accelerate this process. All four identified manufacturers that have not yet announced an 
exit from  the market  belong to  SMEs. According to  publicly  available information,  the 
total  turnover  of  all  companies  is  around  €40  million,  and  the  number  of  employees  is 
around 200. Only part of these sums is attributable to the manufacture and sale of dental 
amalgam. Two of these companies specialize to a large extent in dental amalgam. They 
also  offer  other  dental  products  but  no  other  filling  materials  (Global  Dental  Trade, 
World  Work  Srl).  Depending  on  the  relevance  of  the  amalgam  business,  a  phase-out 
would result in a significant reduction in sales and employment.  

13 Source: targeted consultation (interview with the dentists) 

172 

 
 
                                                           
However, if a company already produces alternatives or can easily switch its production, 
it can compensate for the negative impact. 

The  use  of  mercury-free  alternatives  has  been  growing  in  recent  years;  this  trend  is 
expected to continue. In the baseline, it is estimated that both policy options will increase 
revenues from the manufacturing of dental filling materials. The cumulative revenues of 
the  dental  filling  manufacturing  industry  per  scenario  by  2025,  2027  and  2030  are 
presented in the table below.   

Table  7:  Cumulative  revenues  of  the  dental  filling  manufacturing  industry  by  2025,  2027 
and 2030 (million euros)14  

Option 

Cumulative revenues since 2018 

Baseline 

DA#1a 

DA#1b 

DA#1c 

2025 

2027 

2030 

10,811 - 11,189 

15,564 - 16,039 

18,755 - 19,284 

10,927 -11,243 

15,863 - 16,179 

19,154 - 19,470 

10,877 - 11,220 

15,788 - 16,144 

19,079 - 19,435 

10,856 - 11,210 

15,726 - 16,115 

19,011 - 19,403 

This increase results from the gradual substitution of dental amalgam with mercury-free 
materials and is based on the changes in the share of dental amalgam and mercury-free 
restorations. This estimate assumes that the total number of restorations will remain the 
same regardless of the selection of the restoration material. Therefore, it is assumed that 
the  longevity  between  the  different  types  of  materials  is  not  different.  However,  the 
evidence  of  differences  in  the  performance  of  dental  amalgam  and  mercury-free 
restorations  is  inconclusive.  Even  if  the  performance  of  mercury-free  materials  is 
gradually  improving  due  to  the  enhanced  skills  of  dentists,  this  assumption  has  a 
considerable level of uncertainty.  In addition, the use of dental amalgam will also drop 
significantly under the BAU, and this trend will accelerate due to the implementation of 
the  Member  State  NAPs.  Under  these  assumptions,  the  revenue  will  not  change 
substantially between the BAU and the assessed policy options. 

Impacts on dentists  

In the EU27, in 2020 there were approximately 75 dentists for every 100,000 inhabitants 
on average, however the range varies from  about 35 in Poland to  125 in Greece. Costs 
incurred  by  dentists  because  of  dental  amalgam  use  mainly  include  costs  for  the 
maintenance of amalgam separators and the collection and treatment of amalgam waste 
as  hazardous  waste,  assuming  all  dentists  have  the  separators  installed  by  now.  In  all 
three  sub-options,  the  costs  related  to  the  maintenance  of  amalgam  separators  and  the 
collection  and  treatment  of  amalgam  waste  as  hazardous  waste  will  not  disappear  until 
the last amalgam filling has been removed; it may take 80 years or so. Also, this cost is 
included  in  the  fees  and  therefore  they  are  passed  to  the  patients  or  to  the  health 
insurance. 

14 Source: Deloitte (2020) study 

173 

 
 
 
 
                                                           
On the one hand, in DA#1a, the shorter time to achieve a complete phase-out of dental 
amalgam  may  put  more  pressure  on  dentists  with  limited  experience  in  carrying  out 
mercury-free  restorations.  On  the  other  hand,  in  the  short  term,  this  may  generate  a 
competitive  advantage  for  dentists  already  fully  skilled  in  mercury-free  restoration 
techniques. 

For dentists, the economic impact can be positive or negative depending on their skills in 
handling various filling materials. In the beginning, it will be negative but may become 
positive  because  of  increased  revenues  (the  handling  and  application  of  alternatives 
usually is more expensive).   

The cumulative revenues of dentists based on the number of restorations are presented in 
the table below. 

Table 8: Revenues of the dentists by 2025, 2027 and 2030 (million euros)15  

Option 

Cumulative revenues since 2019 

Baseline 

DA#1a 

DA#1b 

DA#1c 

2025 

2027 

2030 

180,808 - 181,148 

226,159 - 226,549 

271,538 - 271,971 

181,025 -181,287 

226,508 - 226,771 

271,992 - 272,254 

180,926 - 181,219 

226,401 - 226,696 

271,884 - 272,179 

180,874 - 181,182 

226,310 - 226,632 

271,786 - 272,110 

This increase results from the gradual substitution of dental amalgam with mercury-free 
materials and is based on the changes in the share of dental amalgam and mercury-free 
restorations. This estimate assumes that the total number of restorations will remain the 
same regardless of the selection of the restoration material. Therefore, it is assumed that 
the longevity of the different types of materials is not different. 

As  highlighted  by  the  Deloitte  (2020)  study,  a  phase-out  of  dental  amalgam  is  also 
expected  to  affect  costs  that  are  borne  by  dentists  for  the  collection  and  treatment  of 
waste  from  amalgam  separators.  This  cost  will  vary  across  Member  States  and  within 
countries. For example, in Czechia, the cost per kg of sludge from amalgam separators is 
estimated  at  €15  and  in  DE  at  €60.  According  to  an  expert  opinion,  in  Germany,  the 
collection  from  some  contractors  is  free  of  charge  as  the  costs  are  covered  by  the 
revenues of the waste treatment facilities from the recovery of valuable metals from the 
alloys.  This  may  change  because  without  dental  amalgam  production  there  remain  few 
legal  uses  of  mercury  within  the  EU.  The  amounts  of  waste  from  historical  use  will 
remain  high  within  the  assessed  timeframe  (i.e.,  up  to  2027  or  2030,  depending  on  the 
phase-out  scenario).  In  addition,  as  per  Article  10(2)  of  the  Mercury  Regulation,  the 
effectiveness  and  monitoring  of  the  performance  of  the  dental  amalgam  separators  and 
the  collection  and  treatment  of  the  collected  waste  will  improve.  However,  these  costs 
will not disappear until the last amalgam filling has been removed. Maintenance cycles 
of separators do not depend on the amount of waste collected and would remain constant 
as well. 

15 Source: Deloitte (2020) study 

174 

 
 
 
 
                                                           
Impacts on public authorities 

According to Article 14 of the Mercury Regulation, Member State Authorities report on 
the implementation of the Regulation, including the progress of implementation of their 
National  Action  Plans  concerning  the  phase  down  of  dental  amalgam.  The  monitoring 
and  reporting  of  the  phase-out  and  the  implementation  and  monitoring  of  the 
requirements  on  the  efficiency  and  maintenance  of  amalgam  separators  will  continue 
longer in the case of DA#1c; thus, DA#1a and b represents a lower administrative burden 
on the Member States.  

If  Member  States  impose  financial  penalties  as  a  tool  to  enforce  compliance,  some 
revenues  might  be  generated  through  the  collection  of  fines,  which  may  offset  labour 
costs for any enforcement they may choose to take.   

As discussed earlier, the impacts on citizens, social security systems (public budgets) and 
private healthcare providers will depend on the level of reimbursement by social security 
and/or private medical insurance (Figure 4). However, overall the economic impact of a 
phase-out of the use of dental amalgam is expected to be minimal compared to Member 
States national healthcare budgets. Figure 5 illustrates that the greatest burden of a dental 
amalgam  phase-out  on  the  national  healthcare  budget  may  be  incurred  by  SI,  SK,  BU, 
and the CZ (between 0.4% and 0.7% of their national healthcare budgets). This is based 
on the assumption that all costs associated with a shift towards mercury-free alternatives 
are covered by national insurance schemes. However, it is likely that this will not be the 
case for all Member States where costs may be shared over national or private insurance 
schemes or transferred to patients. 

Figure 5: Cost to Member States associated with dental amalgam phase-out (2025, 2027 and 
2030), expressed as a % of national healthcare budgets 

175 

 
 
 
Impacts on crematoria  

All the measures will lead to a gradual reduction in mercury emissions from crematoria 
with DA#1a starting this decline sooner than the others. However, given the lifetime of 
dental amalgam  restorations and the existence of specific cremation practices in certain 
Member States,  this positive effect  will only be  observed in the long term.  In the mid-
term,  the  phase-out  is  not  expected  to  significantly  reduce  mercury  abatement  costs 
incurred  by  crematoria.  In  the  long-term,  the  dental  amalgam  phase-out  will  ultimately 
have  a  positive  economic  effect  by  avoiding  the  need  for  installing  mercury  abatement 
devices  in  new  EU  crematoria  or  operating  the  systems  already  in  place  (only  small 
quantities of dental amalgam would still be used within the EU). However, these benefits 
will  materialise  following  a  delay  due  to  the  lag  in  dental  restorations  reaching 
crematoria.  Where  measures  are  adopted  to  increase  uptake  of  emissions  abatement  at 
crematoria, these benefits would be reduced due to the costs of implementing abatement. 

Impacts on waste management companies 

In the case of a phase-out dental amalgam use will drastically decrease, but this will not 
change  the  volume  of  sludge  captured  in  amalgam  separators,  and  there  is  no  efficient 
way to separate dental amalgam particles from mercury-free filling particles captured by 
the separator. In the long term, it can be expected that there will be reduced revenues for 
companies  that  manufacture,  install  and  maintain  amalgam  separators  as  well  as  for 
companies that collect and treat dental mercury-containing waste. Some companies offer 
several or all these services to dentists. However, in the short term (a few decades after 
the  phase-out),  there  will  still  be  a  need  for  amalgam  separators  and  treatment  of  the 
collected hazardous waste. 

The  cost  arising  from  recycling  services  related  to  amalgam  separators  include  the 
collection  of  amalgam  waste  from  dental  offices  and  the  provision  of  related  supplies, 
such as packaging, labels, etc. At the EU level, according to the stakeholders consulted 
during the 2012 study, there is a significant variation in the costs incurred by dentists for 
the  management  of  amalgam  sludge:  reported  costs  range  from  €100  to  €600  per  year, 
with  an average cost  of approximately  €310 per  year per dentist.  With the reduction of 
dental amalgam, these costs will be reduced. 

For wastewater treatment plant (WWTP) operators, the consequence of mercury levels in 
sewage sludge above allowed thresholds is the impossibility of discarding the sludge as 
fertilizer  for  agricultural  use.  Instead,  mercury-contaminated  sludge  needs  to  be 
incinerated at a high cost. Thus, reducing mercury release is a positive economic impact 
for these operators from a sludge utilisation point of view. However, the installation of 
separators  should  already  have  reduced  mercury  input  into  the  sewage  system  if  the 
separators  are  correctly  operated.  A  certain  amount  of  mercury  is  expected  to  evade 
control  measures  and  still  enter  the  sewage  system.  Moreover,  historic  mercury-
containing  sediments  in  sewage  pipes  may  still  contaminate  ‘fresh’  sewage  so  mercury 
levels remain too high. 

Impacts on competitiveness and innovation  

The  positive  effect  of  the  phase-out  on  innovation  within  the  EU  dental  industry  is 
expected to be greater for DA#1a and b than under DA#1c, given the limited time scale 
to  fully  substitute  dental  amalgam,  although  impacts  for  innovation  are  expected  to  be 
minimal. The use of mercury-free alternatives has been growing in recent years, and this 

176 

 
 
trend  is  expected  to  continue.  In  turn,  projected  demand  for  mercury-free  materials  is 
expected  to  boost  further  investments  in  research  and  development  (R&D)  and 
innovation. 

The  phase-out  would  accelerate  the  shift  from  the  use  of  dental  amalgam  in  dentistry 
towards  mercury-free  alternatives,  stimulating  research  and  innovation  for  improving 
technical characteristics and increasing the competitiveness of the dental filling industry. 
The acceleration will be highest for DA#1arelative to DA#1b and DA#1c as it would be 
conducted in a shorter time span. Such innovations are likely to improve the performance 
of  alternatives  (e.g.,  longevity,  negative  impacts  such  as  allergies)  and  decrease 
production, handling and application costs, thereby making them more affordable.  

Most dentists in the dental care sector are micro-enterprises,  while all remaining dental 
amalgam  manufacturers  in  the  EU  are  SMEs.  Other  companies  linked  to  amalgam  use 
are  manufacturers  of  supplies,  tools  and  amalgam  separators  as  well  as  companies 
specialised in amalgam waste disposal. 

The impacts on those producing amalgam will indeed be negative (reduced demand) and 
those  manufacturing  alternatives  positive  (increased  demand),  while  for  other  actors,  it 
will vary, e.g., initially positive for those dealing with mercury-containing waste and then 
it will decrease gradually as the waste quantities will decrease.  

Other impacts 

Because  mercury  pollution  is  a  global  issue,  it  is  important  to  note  that  the  phase-out's 
environmental,  public  health,  and  safety  benefits  are  likely  to  extend  outside  the  EU 
territory.  

Furthermore,  it  may  trigger  the  adoption  of  a  similar  phase-out  in  some  non-EU 
countries,  especially  given  the  context  of  recent  discussions  as  part  of  the  Minamata 
Convention and the fact that dental amalgam is among the main mercury uses worldwide. 

Measure  DA#2:  Communication  campaign  to  raise  awareness  and  change 
behaviour of dental patients (and practitioners) towards mercury-free dental filling 
alternatives 

This option may contain several campaigns to improve the knowledge and understanding 
of patients and health practitioners such as: 

  a  patient  awareness  campaign  on  the  current  knowledge  of  the  risks  associated 

with amalgam and the indications for the removal of old amalgam  

  a campaign to evaluate current professional practices in relation to monitoring of 

urinary mercury in health professionals 

 

the  publication  of  a  standard  protocol  for  removal  issued  by  a  learned  society, 
specifying, among other things, whether a chelating agent should be prescribed to 
the  patient  prior  to  removal,  its  nature  and  the  dosage  indicated,  and  the 
information that only the HgP3 mask is likely to protect against mercury vapours 

 

the continuation of initial training for future practitioners on the risks associated 
with removal and waste management beyond 2030 

177 

 
 
Some European countries have adopted a policy focused on access to oral health, with a 
strong  emphasis  on  prevention.  These  policies  were  adopted  several  years  ago, 
particularly  in  Germany,  and  are  now  bearing  fruit16.  However,  new  campaigns  cannot 
improve the dental health status of people who already have treated cavities. In Germany, 
for example, the number of cavities per children (12  years) decreased by  90% between 
 2016), the number of dental restorations 
1989/1992 and 2014. At the same time (1991 
decreased only by half17 . Therefore, while measures to improve prevention are effective 
to  avoid  new  cavities,  a strong  impact  on  the  total  number  of  restorations  per  year  can 
only be expected after several decades. 

Assessment of social and economic impacts 

The impact of health improvement campaigns cannot be measured in absolute magnitude 
but  on  the  degree  of  their  effectiveness.  For  such  campaigns,  studies  have  highlighted 
various aspects of socio-economic inequality which will impact their effectiveness, such 
as:  

  Coverage of state social security versus private medical insurance across Member 

States 

  Dependence on public versus private insurance for dental care 

 

Income disparities among patients 

  Density of dental personnel available for citizens more likely to improve than the 

median household 

The impact of the measures taken by Member States under this measure is expected to be 
positive with regard to employment. Jobs may first be created for organising awareness-
raising activities, although these jobs may use the existing personnel or temporary ones 
created only for a short period. Jobs may also be created to train dentists in mercury-free 
restoration techniques. Finally, as this option is expected to foster innovation in mercury-
free  filling  materials,  it  may  also  generate  new  employment  opportunities  in  R&D 
activities of the dental industry. 

Assessment of environmental and health impacts 

The actual impacts of this measure are difficult to quantify because of the non-mandatory 
nature  of  this  option.  Member  States  would  be  free  to  choose  which  measure  or 
combination  of  measures  they  would  implement  to  promote  a  reduction  in  dental 
amalgam use, with no binding target to achieve. 

However,  for  the  present  assessment,  it  can  be  assumed  that  this  policy  option  would 
achieve  a  slightly  better  result  than  the  baseline  but  nowhere  near  as  good  as  DA#1 
(phase-out). 

16  Association de la santé publique bucco-dentaire (ASPBD). La santé bucco-dentaire, un enjeu de santé  
publique. Mis en ligne 14/06/2019. //aspbd.fr/la-sante-bucco-dentaire-un-enjeu-de-sante-publique/  
      Association dentaire Française. Démarche écoresponsable au cabinet dentaire. Grille d’aide à la  mise 

en œuvre : enjeux, outils et pistes de réﬂexion. Dossier ADF 2021. 

17  Hagemann,  S.  (2021):  Entwicklung  von  Kriterien  zur  Beurteilung  der  Wirksamkeit  der  Minamata-

Konvention zu Quecksilber (UBA-Texte, 110/2021) 

178 

 
 
                                                           
Measure DA#3: Raise prices of dental amalgam reflecting risks due to mercury 
exposure 

Improvements  in  social  security  coverage  are  broadly  expected  to  accelerate  the 
reduction of mercury content, as shown in the previous consultations18; patients tend to 
prefer mercury-free alternatives and are likely to benefit from improved reimbursement 
shares or higher amalgam prices (which should discourage demand). Making quantitative 
estimates  of  the  impacts  of  this  measure  is  difficult  because  of  the  lack  of  data  on  the 
price  difference  between  amalgam  and  alternatives  across  the  Member  States  and 
different  systems  of  reimbursement  by  the  state  social  security  and  private  medical 
insurance. 

The elasticity measures for mercury-free options and better reimbursement shares in this 
measure shall improve consumer welfare and access to sustainable and safe dental care. 
The  other  side  of  the  argument  stands  in  understanding  the  increase  in  public  costs  for 
reimbursement,  whose  financing  shall  need  further  scrutiny.  There  is  also  a  need  to 
analyse  the  dependence  of  complementary  private  medical  insurance  versus  state-
sponsored insurance schemes. A further incentive to improve the impacts of this measure 
would be to promote better dental coverage within the market of private insurers. 

As  the  social  security  schemes  vary  significantly  across  Member  States  and  the  EU 
cannot  directly  influence  the  fiscal  and  social  taxation  systems,  the  EU’s  role  in 
decreasing  the  price  difference  between  dental  amalgam  and  mercury-free  alternatives 
would  be  rather  limited.  However,  the  EU  could  encourage  knowledge  sharing  and 
inform Member States of good practices and approaches. Recently, France has adopted a 
new programme, “100% Santé”, which helps patients to  get treatments  with 100% cost 
reimbursed  (through  social  security  and  complementary  private  insurance)  even  when 
getting the dental treatment using alternatives; see the infographic below. 

18 https://ec.europa.eu/eusurvey/publication/MinamataConvention 

179 

 
 
                                                           
180 

 
 
 
 
Similarly,  there  are  specific  measures  in  France  for  those  with  limited  income  (called 
Complémentaire Santé Solidaire) to get medical treatment without spending money and 
seeking reimbursement.  

181 

 
 
Problem Area 2: Mercury emissions from crematoria 
The following impacts  from measures  addressing emissions  from  crematoria have been 
assessed  quantitatively  by  adapting  the  quantitative  framework  developed  for  the 
baseline: 

  Capital  and  operational  costs  to  crematoria  operators  of  installing  and  using 

mercury emissions abatement techniques 

  Where  relevant,  administrative  burdens  to  operators  and  Member  State 
Competent  Authorities  (MSCAs)  from  any  monitoring,  reporting  and 
enforcement requirements under the measure 

  Health  and  environmental  benefits  resulting  from  mercury  emissions 

reductions; and 

  Benefits  resulting  from  emissions  reductions  for  other  pollutants,  primarily 

particulate matter (PM). 

Impacts for each measure were assessed for a scenario year of 2030 taking account of a 
number of potential crematoria activity thresholds, expressed in  numbers of cremations 
undertaken  at  an  installation  annually.  In  addition  to  considering  no  activity  threshold, 
the following annual cremation thresholds were assessed: 1,000; 2,000; 3,000; 4,000; and 
5,000.  Crematoria  operating  below  these  thresholds  are  considered  exempt  from  the 
requirements  of  the  measure,  in  much  the  same  way  that  activity  thresholds  are 
implemented in other policy, including the Medium Combustion Plant Directive (MCPD) 
and Industrial Emissions Directive (IED).  

The  impact  of  each  measure  was  assessed  by  considering  its  impact  on  the  uptake  of 
emissions  abatement  techniques.  As  such,  the  first  step  in  the  impact  assessment  was 
defining  assumptions  on  the  increased  uptake  of  abatement  technologies  for  each 
measure, over and above the baseline. 

Measure CRE#1a: Issue EU guidance on emissions abatement in crematoria 

Assessment of economic impacts 

The  introduction  of  EU  guidance  on  emissions  abatement  in  crematoria  is  assumed  to 
result in a 5% increase in mercury emissions abatement across the EU27. This is low as 
such voluntary guidance typically does not have a significant impact in practice without 
supporting legislation.  

The potential EU-wide capital and operational costs to crematoria operating in different 
activity  bands  are  displayed  in  Table  9,  along  with  an  equivalent  annual  cost  (EAC) 
calculated  over  a  17.5-year  appraisal  period19,  and  assuming  a  3%  discount  rate  in  line 
with  the  Better  Regulation  Guidelines20.  The  greatest  costs  are  incurred  among 
crematoria  operating  at  fewer  than  1,000  cremations  annually,  largely  driven  by  the 

19  Information gained through stakeholder consultation indicated that crematoria have a typical operational 
life of 15 to 20 years; the average of these estimates was used as the appraisal period. As a sensitivity 
test, EACs have also been calculated assuming a 15- and 20-year appraisal period. 

20  EC 

(2021).  Better  Regulation  Toolbox.  https://ec.europa.eu/info/sites/default/files/br_toolbox-

nov_2021_en_0.pdf 

182 

 
 
                                                           
proportionally greater number of crematoria operating at this capacity compared to other 
capacity bands. It is important to note that the costs presented assume that EU guidance 
would  lead  to  some  uptake  of  abatement  over  and  above  the  baseline  situation.  In 
practice, this would be down to the individual operators of crematoria and/or the Member 
States  e.g.,  in  case  they  use  the  guidance  to  implement  requirements  at  a  national  (or 
local or regional) level.  

Table 9 : Capital and operational costs to crematoria operators under CRE#1a, 2030 

Cost 

Crematoria in annual capacity band 
<1,000 

- 

Capital21 

1,000 
2,000 
€1.0 
million 
Operational22  €200,000  €30,000 
EAC23 

€6.5 
million 

2,000  – 
3,000 
€1.3 
million 
€40,000 

€20,000 
€680,000  €110,000  €130,000  €60,000 

€20,000 
€50,000 

€10,000 
€40,000 

3,000  – 
4,000 
€600,000  €500,000  €400,000  €10.3 

4,000  – 
5,000 

>5,000 

Total 

EAC 
sensitivity 
test 

€640,000 
– 
€740,000 

€100,000 
– 
€120,000 

€130,000 
– 
€150,000 

€60,000 
– 
€70,000 

€50,000 
– 
€60,000 

€40,000 
– 
€50,000 

million 
€320,000 
€1.1 
million21 
€1.0 
million  – 
€1.2 
million 

The  cremation  sector  is  not  anticipated  to  incur  any  administrative  burdens  from  the 
introduction  of  sector-specific  guidance.  European  Union  institutions  producing  the 
guidance are likely to face some level of cost in doing so. This would vary depending on 
the scope of the guidance; a light-touch approach which sets out BAT, like the OSPAR 
Recommendation, is unlikely to require significant resources; guidance more prescriptive 
in its requirements, such as the UK’s Process Guidance Note 5/2 (12)24, which also sets 
out  ELVs  and  monitoring  requirements,  would  require  more  time  and  input  to  draft. 
However,  it  is  not  anticipated  that  any  guidance  produced  would  require  time  and 
resources exceeding existing institutional resources and budgets. 

Crematoria operators that implement  abatement  technologies are likely to pass  some or 
all  of  the  capital  and  operational  costs  on  to  consumers,  who  would  pay  more  for  the 
same services. The extent to which crematoria operators would pass on these costs is not 
known,  although  information  provided  by  stakeholders  indicated  that  operators  had 
introduced  an  ‘environmental  fee’  to  offset  their  abatement  costs,  and  that  this  was 
largely accepted by customers. 

Assessment of social impacts 

Mercury  exposure  is  associated  with  cardiovascular  mortality,  IQ  loss  in  younger  age 
groups, and anaemia. The human health benefits associated with this measure have been 
estimated by combining the resulting mercury emissions reductions (estimated at 17 kg 

21 Rounded to the nearest €100,000. 
22 Rounded to the nearest €10,000. 
23 Rounded to the nearest €10,000 unless otherwise stated. 
24 Defra (2012). Process Guidance Note 5/2 (12): Statutory Guidance for Crematory. 

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/6114
78/process-guidance-note-crematoria.pdf 

183 

 
 
 
                                                           
(6-29  kg))  with  EEA  human  health  damage  costs;  estimated  benefits  are  presented  in 
Table 10. The figures show that this measure is expected to deliver human health benefits 
of  approximately  €300,000  (€100,000-€520,000)  when  applied  across  all  crematoria, 
with  the  greatest  benefit  gained  through  emissions  reductions  among  crematoria 
operating at capacities of between 2,000-3,000 cremations annually. 

Table 10 : Human health benefits of mercury emissions reductions under CRE#1a, 203025 

Benefit 
estimate 

Crematoria in annual capacity band 
<1,000 

– 

- 

Low 
Central 
High 

€0 
€20,000 
€30,000 

1,000 
2,000 
€0 
€30,000 
€60,000 

2,000 
3,000 
€20,000 
€70,000 
€130,000 

3,000  – 
4,000 
€10,000 
€50,000 
€90,000 

4,000  – 
5,000 
€20,000 
€50,000 
€80,000 

>5,000 

Total 

€50,000 
€90,000 
€130,000 

€100,000 
€300,000 
€520,000 

Human  health  benefits  would  also  be  experienced  through  reductions  in  emissions  of 
PM2.5  and  other  pollutants  (including  lead,  cadmium,  arsenic,  chromium,  nickel  and 
dioxins  and  furans);  estimated  benefits  are  presented  in  Table  11.  Total  human  health 
benefits assuming no activity threshold are estimated at €36,000 (€23,000-€49,000). 

Table 11: Human health benefits of PM2.5 and other  emissions reductions under  CRE#1a, 
203026 

Benefit 
estimate 

Low 
Central 
High 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 
 €3,000  
 €4,000  
 €6,000  

2,000 
3,000 
 €4,000  
 €7,000  
 €9,000  

– 

3,000 
4,000 
 €3,000  
 €4,000  
 €6,000  

4,000 
5,000 
 €3,000  
 €4,000  
 €6,000  

– 

>5,000 

Total 

 €5,000  
 €7,000  
 €10,000  

 €23,000  
 €36,000  
 €49,000  

 €6,000  
 €9,000  
 €13,000  

Assessment of environmental impacts 

This measure is estimated to result in an estimated mercury emissions reduction of 17 kg 
(6-29  kg)  in  2030,  compared  to  2030  baseline  emissions  of  355  kg  (107-674  kg).  Any 
reduction in mercury emissions would result in an improvement in the quality of natural 
resources. Most directly, it would result in improved air quality which would indirectly 
result  in  reduced  mercury  deposition  to  soil  and  waterbodies.  In  turn,  the  improved 
environmental  quality  could  result  in  further  indirect  human  health  benefits;  seafood  is 
the primary source of human exposure to mercury, and reduced presence of mercury in 
environmental media would lead to reduced mercury in human food sources. However, it 
is not possible to quantify (or value) the environmental impacts with any certainty. 

Summary 

The  total  quantified  costs  and  benefits  of  implementing  this  measure  are  displayed  in 
Table 12, assuming no activity threshold. The net impact of the measure is estimated at a 
cost of €750,000 in 2030. 

25 Figures rounded to the nearest €10,000. 
26 Rounded to the nearest €1,000. 

184 

 
 
 
 
                                                           
Table 12 : Net impact of CRE#1a, assuming no threshold, 203027 

Cost/benef
it estimate 

Mercury 
emissions 
reduction28 
PM2.5  and 
other 
pollutant 
emissions 
reduction28 
Capital 
and 
operationa
l 
costs 
(EAC) 29 
Net 
impact29 
Benefit-
cost ratio 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 
-€30,000 

2,000 
3,000 
-€70,000 

– 

3,000 
4,000 
-€50,000 

4,000 
5,000 
-€50,000 

– 

>5,000 

Total 

-€90,000 

-€300,000 

-€20,000 

-€9,000 

-€4,000 

-€7,000 

-€4,000 

-€4,000 

-€7,000 

-€36,000 

€680,000 

€110,000 

€130,000 

€60,000 

€50,000 

€40,000 

€1.1 
million30 

€650,000 

€70,000 

€60,000 

€10,000 

€2,00031 

-€50,000 

€750,000 

0.04 

0.31 

0.57 

0.82 

0.96 

2.22 

0.31 

At  a  net  cost  of  €750,000  and  delivering  a  mercury  emissions  reduction  of  17 kg,  this 
measure  delivers  reductions  at  a  cost  of  €44,000  per  kg  of  mercury  abated.  The  net 
impacts  of  abatement  by  crematorium  capacity  are  displayed  in  Figure  6,  and  indicate 
that emissions reductions among crematoria operating at <1,000 cremations per year cost 
approximately  €660,000  per  kilogram.  The  cost  of  emissions  reductions  among 
crematoria at 1,000-2,000 cremations per year are much less (€50,000). The benefits of 
emissions  reductions  in  crematoria  exceeding  5,000  cremations  per  year  outweigh  the 
costs,  as  the  number  of  installations  in  these  bands  required  to  implement  abatement 
techniques is smaller than in the lower operating capacities but they emit more. 

27 Figures that are negative and presented in green font represent a benefit. 
28 Rounded to the nearest €10,000. 
29 Rounded to the nearest €10,000 unless otherwise stated. 
30 Rounded to the nearest €100,000. 
31 Rounded to the nearest €1,000. 

185 

 
 
 
 
 
 
 
 
 
 
                                                           
Figure 6: Net cost effectiveness per kilogram of mercury abated under CRE#1a in different 
capacity bands32 

The total quantified costs and benefits of implementing this measure in combination with 
different  dental  amalgam  phase-out  scenarios  are  displayed  in  Table  12  Capital  and 
operational  costs  to  crematoria  operators,  as  well  as  the  benefits  in  terms  of  PM2.5 
reductions are the same as those reported in Table 12. When combined with any dental 
amalgam  scenario,  the  measure  is  less  cost  beneficial  than  implementation  without  a 
phase-out. This is because the costs of implementing emissions abatement remain at the 
same level, but the total emissions which can be abated are reduced, resulting in smaller 
human  health  benefits.  The  total  costs  range  from  €750,000  where  a  2030  phase-out  is 
adopted to €800,000 where a 2025 phase-out is implemented. 

Table  13 :  Net  impact  of  CRE#1a  along  with  dental  amalgam  phase-outs,  assuming  no 
threshold, 203033 

Cost/benef
it estimate 

Mercury 
emissions 
reduction34 
Net 
impact34 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 

2,000 
3,000 

3,000 
4,000 

– 

4,000 
5,000 

– 

>5,000 

Total 

In combination with 2025 dental amalgam phase-out 

-€20,000 

-€30,000 

-€60,000 

-€40,000 

-€40,000 

-€70,000 

-€260,000 

€660,000 

€80,000 

€70,000 

€20,000 

€10,000 

-€30,000 

€800,000 

In combination with 2027 dental amalgam phase-out 

32 Negative costs denote a net benefit. 
33 Figures that are negative and presented in green font represent a benefit. 
34 Rounded to the nearest €10,000. 

186 

 
 
 
                                                           
Cost/benef
it estimate 

Mercury 
emissions 
reduction34 
Net 
impact34 

Mercury 
emissions 
reduction34 
Net 
impact34 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 
-€30,000 

2,000 
3,000 
-€70,000 

– 

3,000 
4,000 
-€40,000 

4,000 
5,000 
-€40,000 

– 

>5,000 

Total 

-€80,000 

-€270,000 

-€20,000 

€660,000 

€80,000 

€60,000 

€20,000 

€10,000 

-€40,000 

€770,000 

In combination with 2030 dental amalgam phase-out 

-€20,000 

-€30,000 

-€70,000 

-€50,000 

-€50,000 

-€90,000 

-€300,000 

€650,000 

€70,000 

€60,000 

€10,000 

€3,00035 

-€50,000 

€750,000 

Measure  CRE#1b:  Issue  EU  guidance  accompanied  by  voluntary  agreements 
for the sector 

Assessment of economic impacts 

Implementation of EU guidance alongside a voluntary agreement for the cremation sector 
is assumed to result in a 15% increase in mercury emissions abatement i.e., an increase in 
uptake of 10% over and above the measure just considering guidance. Such uptake rates 
are  highly  uncertain  and  depend  on  the  exact  content  of  the  guidance  and,  for  this 
measure, the extent of any voluntary agreement. Higher uptake rates may be possible.  

The EU-wide capital and operational costs, and EAC, to crematoria operating in different 
activity  bands  are  displayed  in  Table  14.  The  greatest  costs  are  incurred  among 
crematoria operating at fewer than 1,000 cremations annually. 

Table 14: Capital and operational costs to crematoria operators under CRE#1b, 2030 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 
€3.1 
million 
€100,000 

2,000 
3,000 
€3.8 
million 
€120,000 

– 

3,000 
4,000 
€1.8 
million 
€60,000 

4,000 
5,000 
€1.6 
million 
€50,000 

– 

>5,000 

Total 

€1.2 
million 
€40,000 

€30.9 
million 
€960,000 

€300,000 

€400,000 

€200,000 

€200,000 

€100,000 

€400,000 

€200,000 

€200,000 

€100,000 

€300,000 
– 
€400,000 

€3.3 
million 
€3.0 
million  – 
€3.5 
million 

Cost 

Capital36 

Operational
37 
EAC38 

EAC 
sensitivity 
test 

€19.4 
million 
€600,000 

€2.0 
million 
€1.9 
million  – 
€2.2 
million 

35   Rounded to the nearest €1,000. 
36   Rounded to the nearest €100,000. 
37   Rounded to the nearest €10,000. 
38   Rounded to the nearest €100,000. Based on an appraisal period of 10 years, and assuming a discount 

rate of 3% in line with EC Better Regulation guidance. 

187 

 
 
 
                                                           
Given  that  the  measure  concerns  the  introduction  of  guidance  to  the  cremation  sector 
alongside a voluntary industry agreement, it is not anticipated to have significant impacts 
on SMEs. 

Sector  guidance  is  unlikely  to  have  any  administrative  implications  to  crematoria 
operators,  and  any  administrative  actions  required  as  part  of  voluntary  agreement 
membership  are  likely  to  be  minor  and  will  not  require  significant  resources  from 
industry.  EU  institutions  may  be  required  to  dedicate  resources  in  the  development  of 
sector guidance and the administration of any sector voluntary agreement, but this is not 
expected to  require resources beyond the capacity  of current  institutional resources and 
budgets. 

Assessment of social impacts 

The human health benefits associated with mercury emissions reductions resulting from 
this measure (51 kg (18-88 kg)) have been valued using EEA damage costs; these values 
are presented in Table 15. This measure is expected to deliver human health benefits in 
the  order  of  €900,000  (€310,000-€1.6  million)  when  implemented  without  an  activity 
threshold. 

Table 15: Human health benefits of mercury emissions reductions under CRE#1b, 203039 

Benefit 
estimate 

Crematoria in annual capacity band 
– 
<1,000 

- 

Low 
Central 
High 

€10,000 
€50,000 
€100,000 

1,000 
2,000 
€10,000 
€90,000 
€170,000 

2,000 
3,000 
€50,000 
€210,000 
€400,000 

– 

3,000 
4,000 
€40,000 
€140,000 
€260,000 

4,000 
5,000 
€260,000 
€140,000 
€240,000 

– 

>5,000 

Total 

€140,000 
€270,000 
€390,000 

€310,000 
€900,000 
€1.6 
million40 

Human  health  benefits  have  also  been  valued  for  the  reductions  in  emissions  of  PM2.5 
and other pollutants (including lead, cadmium, arsenic, chromium, nickel and dioxins and 
furans) resulting from this measure (see Table 16). Assuming no activity threshold, the 
total human health benefits are estimated at €110,000 (€70,000-€150,000).  

Table 16: Human health benefits of PM2.5 and other emissions reductions under CRE#1b, 
203041 

Benefit 
estimat
e 
Low 
Central 
High 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 
 € 10,000  
 € 10,000  
 € 20,000  

2,000 
3,000 
 € 10,000  
 € 20,000  
 € 30,000  

– 

3,000 
4,000 
 € 10,000  
 € 10,000  
 € 20,000  

– 

4,000 
5,000 
 € 10,000  
 € 10,000  
 € 20,000  

>5,000 

Total 

 € 10,000  
 € 20,000  
 € 30,000  

 € 70,000  
 € 110,000  
 € 150,000  

 € 20,000  
 € 30,000  
 € 40,000  

39 Rounded to the nearest €10,000 unless otherwise stated. 
40 Rounded to the nearest €100,000. 
41 Rounded to the nearest €10,000 unless otherwise stated. 

188 

 
 
 
 
 
                                                           
Assessment of environmental impacts 

This measure is estimated to result in an estimated mercury emissions reduction of 51 kg 
(18-88 kg) in 2030, compared to 2030 baseline emissions of  355 kg (107-674 kg). The 
reduction  in  mercury  emissions  would  lead  to  improvement  in  environmental  quality, 
including air, soil and water. In turn, this would result in indirect human health benefits, 
as less mercury enters human food sources. Due to the uncertainties in the pathways of 
mercury  in  the  environment  once  emitted  to  air,  and  a  lack  of  data  on  valuing  these 
environmental impacts, it is not possible to quantitatively assess (or value) them. Due to 
the  greater  mercury  emissions  reductions  from  CRE#1b  compared  to  CRE#1a,  the 
environmental benefits will be greater. 

Summary 

The  total  quantified  costs  and  benefits  of  implementing  this  measure  are  displayed  in 
Table 17, assuming no activity threshold. The net impact of the measure is estimated at a 
cost of €2.3 million in 2030. 

Table 17: Net impact of CRE#1b, assuming no threshold, 203042 

Cost/benef
it estimate 

Mercury 
emissions 
reduction43 
PM2.5  and 
other 
pollutant 
emissions 
reduction44 
Capital 
and 
operationa
costs 
l 
(EAC) 45 
Net 
impact46 
Benefit-
cost ratio 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 
-€90,000 

2,000 
3,000 
-€210,000 

– 

3,000 
4,000 
-€140,000 

– 

4,000 
5,000 
-€140,000 

>5,000 

Total 

-€270,000 

-€900,000 

-€50,000 

-€30,000 

-€10,000 

-€20,000 

-€10,000 

-€10,000 

-€20,000 

-€110,000 

€2.0 
million 

€2.0 
million 
0.04 

€300,000 

€400,000 

€200,000 

€200,000 

€100,000 

€200,000 

€200,000 

€30,00047 

€10,00047 

-€200,000 

0.31 

0.57 

0.82 

0.96 

2.22 

€3.3 
million 

€2.2 
million 
0.31 

At a net cost of €2.2 million and delivering a mercury emissions reduction of 51 kg, this 
measure  delivers  reductions  at  a  cost  of  €44,000  per  kg  of  mercury  abated.  The  net 
impacts  of  abatement  by  crematorium  capacity  are  displayed  in  Figure  7,  and  indicate 

42 Figures that are negative and presented in green font represent a benefit. 
43 Rounded to the nearest €100,000. 
44 Rounded to the nearest €10,000. 
45 Rounded to the nearest €100,000. 
46 Rounded to the nearest €100,000, unless otherwise stated. 
47 Rounded to the nearest €10,000. 

189 

 
 
 
                                                           
that emissions reductions among crematoria operating at <1,000 cremations per year cost 
approximately  €660,000  per  kilogram.  The  cost  of  emissions  reductions  among 
crematoria at 1,000-2,000 cremations per year are much less (€50,000). The benefits of 
emissions  reductions  in  crematoria  exceeding  5,000  cremations  per  year  outweigh  the 
costs,  as  the  number  of  installations  in  these  bands  required  to  implement  abatement 
techniques is smaller than in the lower operating capacities but they emit more. 

Figure 7: Net cost per kilogram of mercury abated under CRE#1b in different capacity bands48 

The total quantified costs and benefits of implementing this measure in combination with 
different  dental  amalgam  phase-out  scenarios  are  displayed  in  Table  18.  Capital  and 
operational  costs  to  crematoria  operators,  as  well  as  the  benefits  in  terms  of  PM2.5 
reductions are the same as those reported in Table 17. When combined with any dental 
amalgam  scenario,  the  measure  is  less  cost  beneficial  than  implementation  without  a 
phase-out. This is because the costs of implementing emissions abatement remain at the 
same level, but the total emissions which can be abated are reduced, resulting in smaller 
human health benefits. The total costs range from €2.3 million where a 2030 phase-out is 
adopted to €2.4 million where a 2025 phase-out is implemented. 

Table  18 :  Net  impact  of  CRE#1b  along  with  dental  amalgam  phase-outs,  assuming  no 
threshold, 203049 

Cost/benef
it estimate 

Mercury 
emissions 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 

2,000 
3,000 

3,000 
4,000 

– 

4,000 
5,000 

– 

>5,000 

Total 

In combination with 2025 dental amalgam phase-out 

-€50,000 

-€80,000 

-€190,000 

-€120,000 

-€110,000 

-€210,000 

-€770,000 

48 Negative costs denote a net benefit. 
49 Figures that are negative and presented in green font represent a benefit. 

190 

 
 
 
                                                           
Cost/benef
it estimate 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 

2,000 
3,000 

3,000 
4,000 

– 

4,000 
5,000 

– 

>5,000 

Total 

reduction50 
Net 
impact51 

€2.0 
million 

€200,000 

€200,000 

€50,00052 

€40,00052 

-€100,000 

€2.4 
million 

Mercury 
emissions 
reduction50 
Net 
impact51 

Mercury 
emissions 
reduction50 
Net 
impact51 

In combination with 2027 dental amalgam phase-out 

-€50,000 

-€80,000 

-€200,000 

-€130,000 

-€130,000 

-€240,000 

-€820,000 

€2.0 
million 

€200,000 

€200,000 

€50,00052 

€20,00052 

-€100,000 

€2.3 
million 

In combination with 2030 dental amalgam phase-out 

-€50,000 

-€90,000 

-€210,000 

-€140,000 

-€140,000 

-€270,000 

-€890,000 

€2.0 
million 

€200,000 

€200,000 

€40,00052 

€10,00052 

-€200,000 

€2.3 
million 

Measure  CRE#2:  Define  Best  Available  Techniques  (BAT)  /  Associated 
Emissions Levels (AELs) 

The analysis for this measure has been undertaken for each capacity band independently 
and impacts  aggregated  assuming no activity threshold (i.e. all crematoria, CRE#2a) as 
well as just for large crematoria (i.e. those with a capacity of more than 4,000 cremations 
per  year,  CRE#2b,  and  those  with  a  capacity  of  more  than  3,000  cremations  per  year, 
CRE#2c).  

Assessment of economic impacts 

The introduction of a system for regulating mercury emissions from crematoria based on 
BAT  and  ELVs  is  assumed  to  raise  emissions  abatement  uptake  to  100%  in  Member 
States (above any relevant activity threshold) where such a system is not already in place. 
The  EU-wide  capital  and  operational  costs  to  crematoria  operating  in  different  activity 
bands to install and operate the required abatement are displayed in Table 19, along with 
an EAC value. The greatest costs are incurred among crematoria operating at fewer than 
1,000 cremations annually, driven by the greater number of crematoria operating at this 
capacity  compared  to  other  capacity  bands.  Costs  are  aggregated  for  measure  CRE#2a, 
which  assumes  mandatory  emissions  abatement  at  all  crematoria,  measure  CRE#2b, 
which assumes emissions abatement only at crematoria at annual operating capacities of 
4,000  or  more,  and  measure  CRE#2c,  which  assumes  emissions  abatement  only  at 
crematoria at operating capacities of 3,000 or more. 

50 Rounded to the nearest €100,000. 
51 Rounded to the nearest €100,000, unless otherwise stated. 
52 Rounded to the nearest €10,000. 

191 

 
 
 
                                                           
Table 19: Capital and operational costs to crematoria operators under CRE#2, 2030 

Crematoria in annual capacity band 
<1,000 

– 

- 

Cost 

Capital53 

Operatio
nal54 
EAC53 

EAC 
sensitivit
y test 

1,000 
2,000 
€15 
million 
€500,00
0 
€2 
million 
€1 
million 
– 
million 

€2 

€119 
million 
€3.7 
million 
€13 
million 
€12 
million 
– 
million 

€14 

2,000 
3,000 
€24 
million 
€700,000 

– 

3,000 
4,000 
€10 
million 
€300,000 

– 

4,000 
5,000 
€8 million 

>5,000 

€6 million 

Total 
(CRE#2a) 
€182 million 

Total 
(CRE#2b) 
€15 million 

€300,000 

€200,000 

€5.7 million 

€500,000 

Total 
(CRE#2c) 
€25 
million 
€800,000 

€3 million 

€1 million 

€1 million 

€1 million 

€19 million 

€2 million 

€3 million 

€1 million 

€1 million 

€1 million 

€2 million 
– 
€3 
million 

€18  million  – 
€21 million 

€1  million  – 
€2 million 

€2  million 
– 
€3 
million 

How this measure would impact the position of SMEs is dependent on the level at which 
activity  thresholds  are  set  (if  at  all)  and  is  also  highly  uncertain.  As  shown  above, 
implementing the measure with  no, or a low, activity threshold would incur substantial 
costs to smaller installations. There is potential movement away from significant public 
sector  involvement  in  operation  of  crematoria  to  greater  involvement  from  private 
enterprises.  Limited  data  are  available  on  the  structure  of  the  sector  across  different 
countries across the EU, but there are likely to be SMEs involved, especially in Member 
States  dominated  by  smaller  crematoria 
(including  Spain  and  France).  The 
implementation of no (or a low) activity threshold is likely to have greater implications 
for SMEs within the sector, who would bear greater costs. 

In  addition  to  the  costs  of  implementing  and  operating  mercury  emissions  abatement 
systems  at  their  installations,  crematoria  operators  would  face  added  administrative 
burdens.  This  would  arise  from  the  need  to  submit  information  on  their  abatement 
systems and any periodic emissions monitoring to Member State Competent Authorities, 
who would also encounter a new administrative burden in process information submitted 
by  operators.  It  is  assumed  that  costs  to  both  operators  and  authorities  would  be 
comparable to administrative burdens under the MCPD for installations operating at 1-5 
MW  (see  previous  sections).  Estimated  administrative  costs,  assuming  no  activity 
threshold,  are  presented  in  Table  20.  Administrative  costs  are  estimated  to  amount  to 
€400,000 to operators and €500,000 to authorities in 2030. 

Table 20: Administrative burdens under CRE#2, 203055 

Actors 

Crematoria in annual capacity band 
2,000  – 
<1,000 
3,000 

1,000 
2,000 

- 

3,000 
4,000 

– 

4,000  – 
5,000 

>5,000 

Total 
(CRE#2a) 

To operators 
To authorities 

€250,000 
€310,000 

€50,000 
€70,000 

€50,000 
€60,000 

€20,000 
€20,000 

€10,000 
€20,000 

€10,000 
€10,000 

€400,000 
€500,000 

53 Rounded to the nearest €1 million. 
54 Rounded to the nearest €100,000. 
55 Rounded to the nearest €10,000. 

192 

Total 
(CRE#2
b) 
€20,000 
€30,000 

Total 
(CRE#2
c) 
€40,000 
€50,000 

 
 
 
 
                                                           
Where the requirement to implement mercury emissions abatement is not economically 
feasible and crematoria cease operation, losses in employment would result. These losses 
are expected to be mitigated at least in part by greater employment among manufacturers 
of  abatement  systems,  who  would  see  increased  demand  for  their  products.  Similarly, 
wider  uptake  of  emissions  abatement  systems  at  crematoria  may  result  in  operators 
passing on some or all of the costs to customers. 

Assessment of social impacts 

The human health benefits associated with mercury emissions reductions resulting from 
this  measure  (314 kg  (105-542  kg))  have  been  valued  using  EEA  damage  costs;  these 
values are presented in Table 21. CRE#2 is expected to deliver human health benefits of 
€5.6 million (€1.9 million-€9.5 million) when implemented without an activity threshold. 
Where the measure is applied only to crematoria above an annual operating capacity of 
4,000  or  3,000  cremations,  the  emissions  reductions  and  associated  human  health 
benefits are reduced. 

Table 21: Human health benefits of mercury emissions reductions under CRE#2, 203056 

Benefit 
estimate 

Low 

Central 

High 

Crematoria in annual capacity band 
<1,000 

- 

1,000 
2,000 

2,000  – 
3,000 

3,000  – 
4,000 

4,000  – 
5,000 

>5,000 

€0.1 
million 
€0.3 
million 
€0.6 
million 

€0.1 
million 
€0.6 
million 
€1.1 
million 

€0.3 
million 
€1.3 
million 
€2.5 
million 

€0.2 
million 
€0.9 
million 
€1.6 
million 

€0.4 
million 
€0.8 
million 
€1.4 
million 

€0.9 
million 
€1.7 
million 
€2.3 
million 

Total 
(CRE#2
a) 
€1.9 
million 
€5.5 
million 
€9.5 
million 

Total 
(CRE#2
b) 
€1.2 
million 
€2.5 
million 
€3.7 
million 

Total 
(CRE#2
c) 
€1.5 
million 
€3.4 
million 
€5.3 
million 

Human  health  benefits  from  the  reductions  in  emissions  of  PM2.5  and  a  suite  of  other 
pollutants (including lead, cadmium, arsenic, chromium, nickel and dioxins and furans) 
resulting  from  this  measure  are  displayed  in  Table  20.  Assuming  no  activity  threshold 
(CRE#2a),  the  total  human  health  benefits  are  estimated  at  €620,000  (€390,000-
€850,000).  With  an  activity  threshold  of  4,000  cremations  per  year,  benefits  are 
estimated  at  €180,000  (€120,000-€250,000);  an  activity  threshold  of  3,000  cremations 
per year yields benefits of €260,000 (€160,000-€350,000).  

Table 22: Human health benefits of PM2.5 and other pollutant emissions reductions under 
CRE#2, 203057 

Benefit 
estimate 

Low 

Central 

High 

Crematoria in annual capacity band 
<1,000 

1,000  - 
2,000 

2,000  – 
3,000 

3,000  – 
4,000 

4,000  – 
5,000 

>5,000 

 € 
110,000  
 € 
170,000  
 € 
230,000  

 € 
40,000  
 € 
70,000  
 € 
90,000  

 € 
80,000  
 € 
120,000  
 € 
170,000  

 € 
50,000  
 € 
80,000  
 € 
110,000  

 € 
40,000  
 € 
70,000  
 € 
90,000  

 € 
70,000  
 € 
110,000  
 € 
160,000  

Total 
(CRE#2a
) 
 € 
390,000  
 € 
620,000  
 € 
850,000  

Total 
(CRE#2
b) 
 € 
120,000  
 € 
180,000  
 € 
250,000  

Total 
(CRE#2
c) 
€160,00
0 
€260,00
0 
€350,00
0 

56 Rounded to the nearest €100,000. 
57 Rounded to the nearest €10,000. 

193 

 
 
 
                                                           
Assessment of environmental impacts 

Measure CRE#2a is  estimated to result in an estimated mercury emissions reduction of 
314 kg (105-542 kg) in 2030, compared to 2030 baseline emissions of 355 kg (107-674 
kg).  Where  the  measure  is  implemented  with  an  activity  threshold  of  4,000  cremations 
per year (CRE#2b), emissions reductions are estimated at 141 kg (70-210 kg); an activity 
threshold of 3,000 cremations per year (CRE#2c) would result in emissions reductions of 
191 kg (82-302 kg). As with CRE#1a and CRE#1b, any reduction in mercury emissions 
would  lead  to  improvement  in  environmental  quality,  including  air,  soil  and  water.  In 
turn,  this  would  result  in  indirect  human  health  benefits,  as  less  mercury  enters  human 
food  sources.  Due  to  the  uncertainties  in  the  pathways  of  mercury  in  the  environment 
once emitted to air, and a lack of data on valuing these environmental impacts, it is not 
possible  to  quantitatively  assess  (or  value)  them.  The  greater  mercury  emissions 
reductions  from  CRE#2  compared  to  CRE#1a  and  CRE#1b,  would  deliver  greater 
environmental benefits. 

Summary 

The  total  quantified  costs  and  benefits  of  implementing  this  measure  are  displayed  in 
Table  23,  assuming  no  activity  threshold.  The  net  impact  of  the  measure  without  an 
activity  threshold  (CRE#2a)  is  estimated  at  a  cost  of  €14  million  in  2030  across  all 
crematorium capacity bands. Where an activity threshold of 4,000 cremations per year is 
adopted (CRE#2b), the net impact is estimated at a benefit of approximately €1 million in 
2030, while an activity threshold of 3,000 cremations per year (CRE#2c) is anticipated to 
result in a net benefit of €900,000. 

Table 23: Net impact of CRE#2, assuming no threshold, 203058 

Cost/benefit 
estimate 

Mercury 
emissions 
reduction59 
PM2.5  and 
other 
pollutant 
emissions 
reduction60 
Capital and 
operational 
costs 
(EAC) 59 
Administra
tive  burden 

Crematoria in annual capacity band 
<1,000 

1,000  - 
2,000 

2,000  – 
3,000 

3,000  – 
4,000 

4,000  – 
5,000 

>5,000 

-€0.3 
million 

-€0.6 
million 

-€1.3 
million 

-€0.9 
million 

-€0.8 
million 

-€1.7 
million 

Total 
(CRE#
2a) 
-€5.5 
million 

Total 
(CRE#2
b) 
-€2.5 
million 

Total 
(CRE#2
c) 
-€3.4 
million 

-
€170,00
0 

-
€70,000 

-
€120,00
0 

-
€80,000 

-
€70,000 

-
€110,00
0 

-
€620,00
0 

-
€180,00
0 

-
€260,00
0 

€13 
million 

€2 
million 

€3 
million 

€1 
million 

€1 
million 

€1 
million 

€19 
million 

€2 
million 

€3 
million 

€250,00
0 

€50,000  €50,000  €20,000  €10,000  €10,000  €400,00

€20,000  €40,000 

0 

58 Figures that are negative and presented in green font represent a benefit. 
59 Rounded to the nearest €1 million. 
60 Rounded to the nearest €10,000. 

194 

 
 
 
                                                           
Cost/benefit 
estimate 

to 
operators61 
Administra
tive  burden 
to 
authorities6
1 
Net 
impact62 

Benefit-
cost ratio 

Crematoria in annual capacity band 
<1,000 

1,000  - 
2,000 

2,000  – 
3,000 

3,000  – 
4,000 

4,000  – 
5,000 

>5,000 

Total 
(CRE#
2a) 

Total 
(CRE#2
b) 

Total 
(CRE#2
c) 

€310,00
0 

€70,000  €60,000  €20,000  €20,000  €10,000  €500,00

€30,000  €50,000 

0 

€13 
million5
9 
0.04 

€1 
million5
9 
0.36 

€1 
million5
9 
0.55 

€200,00
0 

€10,000
61 

0.86 

0.99 

-€1 
million5
9 
2.50 

€14 
million5
9 
0.31 

-€1 
million 

1.65 

-
€900,00
0 
1.33 

At  a  net  cost  of  €14  million  and  delivering  a  mercury  emissions  reduction  of  314 kg, 
measure  CRE#2a  delivers  reductions  at  a  cost  of  €45,000  per  kg  of  mercury  abated. 
The  net  impacts  of  abatement  by  crematorium  capacity  are  displayed  in  Figure  8,  and 
indicate that emissions reductions among crematoria operating at <1,000 cremations per 
year cost approximately €750,000 per kilogram. The cost of emissions reductions among 
crematoria at 1,000-2,000 cremations per year are much less (€40,000). The benefits of 
emissions  reductions  in  crematoria  exceeding  5,000  cremations  per  year  outweigh  the 
costs,  as  the  number  of  installations  in  these  bands  required  to  implement  abatement 
techniques is smaller than in the lower operating capacities but they emit more. Where an 
activity threshold of 4,000 cremations per year is adopted with the measure (CRE#2b), an 
estimated 141 kg of mercury emissions are abated at a net benefit of €1 million, resulting 
in  a  benefit  of  €7,000  per  kg  of  mercury  abated.  An  activity  threshold  of  3,000 
cremations  per  year  (CRE#2c)  delivers  mercury  emissions  reductions  at  a  benefit  of 
€5,000 per kg of mercury abated. 

61 Rounded to the nearest €10,000. 
62 Rounded to the nearest €100,000, unless otherwise stated. 

195 

 
 
 
                                                           
Figure  8:  Net  cost  per  kilogram  of  mercury  abated  under  CRE#2a  in  different  capacity 
bands63 

The total quantified costs and benefits of implementing this measure in combination with 
different  dental  amalgam  phase-out  scenarios  are  displayed  in  Table  24.  Capital  and 
operational  costs  to  crematoria  operators,  as  well  as  the  benefits  in  terms  of  PM2.5 
reductions are the same as those reported in Table 23. When combined with any dental 
amalgam  scenario,  the  measure  is  less  cost  beneficial  than  implementation  without  a 
phase-out. This is because the costs of implementing emissions abatement remain at the 
same level, but the total emissions which can be abated are reduced, resulting in smaller 
human health benefits. The total net costs range from €14 million where a 2030 phase-
out is adopted to €15 million where a 2025 phase-out is implemented. Where the measure 
is  implemented  with  an  activity  threshold  of  4,000  cremations  per  year,  it  delivers  net 
benefits in all dental amalgam phase-out scenarios, ranging from €0.5 million in the case 
of a 2025 dental amalgam phase-out, to €1 million in the case of a 2030 dental amalgam 
phase-out. 

Table  24 :  Net  impact  of  CRE#2  along  with  dental  amalgam  phase-outs,  assuming  no 
threshold, 203064 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 

2,000 
3,000 

3,000 
4,000 

– 

4,000 
5,000 

– 

>5,000 

Total 
(CRE#2a) 

Total 
(CRE#2b
) 

Total 
(CRE#2c) 

Cost/benefi
t estimate 

In 
combinatio
n with 2025 
dental 

63 Negative costs denote a net benefit. 
64 Figures that are negative and presented in green font represent a benefit. 

196 

 
 
 
 
 
 
 
 
 
 
 
 
                                                           
Cost/benefi
t estimate 

amalgam 
phase-out 
Mercury 
emissions 
reduction65 
Net 
impact66 

In 
combinatio
n with 2027 
dental 
amalgam 
phase-out 
Mercury 
emissions 
reduction67 
Net 
impact68 

In 
combinatio
n with 2030 
dental 
amalgam 
phase-out 
Mercury 
emissions 
reduction69 
Net 
impact70 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 

2,000 
3,000 

3,000 
4,000 

– 

4,000 
5,000 

– 

>5,000 

Total 
(CRE#2a) 

Total 
(CRE#2b
) 

Total 
(CRE#2c) 

-€0.3 
million 

-€0.5 
million 

-€1.2 
million 

-€0.8 
million 

-€0.7 
million 

€13 
million65 

€1 
million65 

€1 
million65 

€300,000 

€200,000 

-€1.3 
million 

-€0.7 
million 

-€4.7 
million 

-€2.0 
million 

-€2.7 
million 

€15 
million65 

-€500,000 

-€300,000 

-€0.3 
million 

-€0.5 
million 

-€1.3 
million 

-€0.8 
million 

-€0.7 
million 

€13 
million65 

€1 
million65 

€1 
million65 

€200,000 

€100,000 

-€1.5 
million 

-€0.9 
million 

-€5.1 
million 

-€2.2 
million 

€14 
million65 

-€0.8 
million 

-€3.0 
million 

-€0.5 
million 

-€0.3 
million 

-€0.5 
million 

-€1.3 
million 

-€0.9 
million 

-€0.8 
million 

-€1.6 
million 

-€5.5 
million 

-€2.5 
million 

-€3.3 
million 

€13 
million65 

€1 
million65 

€1 
million65 

€200,000 

€20,00071 

-€1 
million65 

€14 
million65 

-€1 
million 

-€900,000 

Measure CRE#3: Mercury benchmarks/reduction targets 

Assessment of economic impacts 

This  measure,  which  entails  the  introduction  of  mercury  benchmarks  or  emission 
reduction  targets  for  the  cremation  sector,  is  assumed  to  increase  emissions  abatement 
uptake  to  100%  in  Member  States  where  there  is  no  regulation  currently  in  place.  As 
such, the number of installations across the EU impacted by the measure are the same as 
in CRE#2a, and the economic impacts are expected to be of the same magnitude. There 
may  be  some  efficiency  savings  for  Member  States  in  that  they  can  choose  the  exact 
approach for regulating the sector based around the benchmark / target values, but they 
are expected to be limited as CRE#2a would also entail some flexibility.  

65 Rounded to the nearest €1 million. 
66 Rounded to the nearest €100,000, unless otherwise stated. 
67 Rounded to the nearest €1 million. 
68 Rounded to the nearest €100,000, unless otherwise stated. 
69 Rounded to the nearest €1 million. 
70 Rounded to the nearest €100,000, unless otherwise stated. 
71 Rounded to the nearest €10,000 

197 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
There  is  also  the  option  to  implement  measure  CRE#3  such  that  it  applies  only  to 
crematoria  operating  above  certain  activity  thresholds.  Where  an  activity  threshold  of 
4,000 cremations per year is adopted, the impacts of measure CRE#3 are anticipated to 
be the same as those described for measure CRE#2b. 

Assessment of social impacts 

The implementation  of mercury  benchmarks  or  emission reduction targets  are expected 
to have the same impact as CRE#2a or CRE#2b (BAT and ELVs) in terms of abatement 
uptake. The impact in terms of emission reductions will therefore also be the same, and 
the  benefits  in  terms  of  human  health  impacts  will  be  the  same  as  those  described  for 
CRE#2a or CRE#2b. 

Assessment of environmental impacts 

Environmental  benefits  resulting  from  mercury  emissions  reductions  induced  by  this 
measure will be the same as those described for CRE#2a or CRE#2b. 

Measure CRE#4: Burden sharing agreements 

Assessment of economic impacts 

This measure involves the establishment of a burden-sharing agreement. The impact of a 
burden-sharing  agreement  on  emissions  abatement  uptake  at  crematoria  in  the  EU  will 
depend on the scope of the measure, but for the purpose of assessment it is assumed to 
result in an uptake of 100% in Member States where there is no regulation currently in 
place. As such, the number of installations across  the EU impacted by the measure are 
the  same  as  in  CRE#2,  and  the  economic  impacts  are  expected  to  be  of  the  same 
magnitude. 

In  addition  to  considering  100%  abatement  uptake,  a  burden-sharing  measure  has  also 
been  considered  with  target  emissions  reductions  of  50%  and  75%  for  the  cremation 
sector  (building  on  the  UK  case  study  whereby  a  50%  reduction  target  is  applied). 
Assuming  that  abatement  would  be  adopted  starting  with  installations  in  the  largest 
capacity  bands  (where  emissions  can  be  reduced  most  cost  effectively)  and  through 
progressively  smaller  installations,  the  compliance  costs,  and  administrative  burdens  of 
this measure with these emissions reductions are displayed in Table 25. 

 Table 25: Economic impacts of CRE#4 with 50% and 75% emissions reductions 

Cost 
Capital  and  operational  costs 
(EAC) 
Administrative  burdens 
operators 
Administrative  burdens 
authorities 

to 

to 

50% emissions reduction 
€2.3  million  (€2.2  million  – 
€2.6 million) 
€40,000 

75% emissions reduction 
€5.1  million  (€4.8  million  – 
€5.6 million) 
€90,000 

€50,000 

€120,000 

Assessment of social impacts 

The implementation  of mercury benchmarks or  emission reduction targets  are expected 
to have the same impact as CRE#2 (BAT and ELVs) in terms of abatement uptake. The 

198 

 
 
 
impact in terms of emission reductions will therefore also be the same, and the benefits in 
terms of human health impacts will be the same as those described for CRE#2. 

Benefits  in  terms  of  human  health  impacts  have  also  been  quantified  for  this  measure 
scenarios  assuming  a  50%  and  75%  emissions  reduction  for  the  cremation  sector.  The 
quantified impacts are displayed in Table 26. 

Table 26: Human health impacts of CRE#4 with 50% and 75% emissions reductions 

from  mercury 

Cost 
Benefits 
emissions reductions 
Benefits 
from  PM2.5  and 
other  pollutant  emissions 
reductions 

50% emissions reduction 
€3.1  million  (€1.4  million  – 
€4.9 million) 
€200,000 
€300,000) 

(€200,000 

– 

75% emissions reduction 
€4.7  million  (€1.7  million  – 
€7.9 million) 
€400,000 
€500,000) 

(€200,000 

– 

Assessment of environmental impacts 

Environmental benefits resulting from mercury emissions reductions induced by measure 
CRE#4 will be the same as those described for CRE#2. 

Summary 

Assuming 100% emissions abatement uptake as a result of this measure, impacts will be 
the same as those set out for CRE#2. 

The impacts  for  this measure,  assuming 50% and 75% emissions  reductions targets  for 
the cremation sector are set out in Table 27 and Table 28. 

Table  27:  Net  impact  of  CRE#4,  assuming  a  50%  emissions  reduction  target  for  the 
cremation sector72 

Cost/benefit 
estimate 

and 

Mercury 
emissions 
reduction73 
PM2.5 
other 
pollutant 
emissions 
reduction74 
Capital  and 
operational 
costs  (EAC) 
73 
Administrat

Crematoria in annual capacity band 

<1,000 

€0 

€0 

1,000 
2,000 
€0 

- 

2,000 
3,000 
€0 

– 

– 

3,000 
4,000 
-€600,000 

– 

4,000 
5,000 
-€800,000 

>5,000 

Total 

-€1.7 
million 

-€3.1 
million 

€0 

€0 

-€60,000 

-€70,000 

-€110,000 

-€240,000 

€0 

€0 

€0 

€1 million  €1 million 

€1 million  €2 million 

€0 

€0 

€0 

€10,000 

€10,000 

€10,000 

€40,000 

72 Figures that are negative and presented in green font represent a benefit. 
73 Rounded to the nearest €100,000. 
74 Rounded to the nearest €10,000. 

199 

 
 
 
                                                           
Cost/benefit 
estimate 

ive  burden 
to 
operators75 
Administrat
ive  burden 
to 
authorities61 
Net 
impact76 

Crematoria in annual capacity band 

<1,000 

1,000 
2,000 

- 

2,000 
3,000 

– 

3,000 
4,000 

– 

4,000 
5,000 

– 

>5,000 

Total 

€0 

€0 

€0 

€20,000 

€20,000 

€10,000 

€50,000 

€0 

€0 

€0 

€100,000 

€10,00075 

-€1 
million73 

-
€900,00073 

Table 28: Net impact of CRE#4, assuming a 75% emissions reduction target for the sector77 

Cost/benefit 
estimate 

and 

Mercury 
emissions 
reduction78 
and 
PM2.5 
other pollutant 
emissions 
reduction79 
Capital 
operational 
costs (EAC) 78 
Administrative 
to 
burden 
operators80 
Administrative 
burden 
to 
authorities61 
Net impact81 

Crematoria in annual capacity band 
<1,000  1,000  - 

– 

€0 

2,000 
€0 

2,000 
3,000 
-€1 million 

3,000  – 
4,000 
-€1 
million 

4,000 
5,000 
-€1 
million 

€0 

€0 

-€120,000 

-€80,000 

-€70,000 

– 

>5,000 

Total 

-€2 
million 

-€5 
million 

-
€110,000 

-
€380,000 

€0 

€0 

€3 million 

€1 
million 

€1 
million 

€1 
million 

€5 
million 

€0 

€0 

€50,000 

€20,000 

€10,000 

€10,000 

€90,000 

€0 

€0 

€60,000 

€20,000 

€20,000 

€10,000 

€120,000 

€0 

€0 

€1 
million78 

€200,000  €10,00080 

-€1 
million78 

€300,000 

The total quantified costs and benefits of implementing this measure in combination with 
different  dental  amalgam  phase-out  scenarios  are  displayed  in  Table  28  and  Table  30. 
Capital and operational costs to crematoria operators, as well as the benefits in terms of 
PM2.5  reductions  are  the  same  as  those  reported  in  Table  27  and  Table  28.  When 
combined  with  any  dental  amalgam  scenario,  the  measure  is  less  cost  beneficial  than 

75 Rounded to the nearest €10,000. 
76 Rounded to the nearest €100,000, unless otherwise stated. 
77 Figures that are negative and presented in green font represent a benefit. 
78 Rounded to the nearest €1 million. 
79 Rounded to the nearest €10,000. 
80 Rounded to the nearest €10,000. 
81 Rounded to the nearest €100,000, unless otherwise stated. 

200 

 
 
 
                                                           
implementation without a phase-out. This is because the costs of implementing emissions 
abatement  remain  at  the  same  level,  but  the  total  emissions  which  can  be  abated  are 
reduced, resulting in smaller human health benefits. The net impacts range from a benefit 
of €200,000 to €800,000 where a 50% emissions reduction target is adopted, to a cost of 
€400,000 to €1 million where a 75% reduction target is in effect. 

Table  29 :  Net  impact  of  CRE#4  (50%  emissions  reduction  target)  along  with  dental 
amalgam phase-outs, assuming no threshold, 203082 

Cost/benef
it estimate 

Mercury 
emissions 
reduction83 
Net 
impact84 

Mercury 
emissions 
reduction83 
Net 
impact84 

Mercury 
emissions 
reduction83 
Net 
impact84 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 

2,000 
3,000 

3,000 
4,000 

– 

4,000 
5,000 

– 

>5,000 

Total 

€0 

€0 

€0 

€0 

€0 

€0 

In combination with 2025 dental amalgam phase-out 

€0 

€0 

€0 

€0 

-€700,000 

-€700,000 

-€1.3 
million 

-€2.7 
million 

€200,000 

€200,000 

-€700,000 

-€300,000 

In combination with 2027 dental amalgam phase-out 

€0 

€0 

€0 

€0 

-€700,000 

-€700,000 

-€1.5 
million 

-€2.9 
million 

€200,000 

€100,000 

-€800,000 

-€600,000 

In combination with 2030 dental amalgam phase-out 

€0 

€0 

€0 

€0 

-€600,000 

-€800,000 

-€1.6 
million 

-€3.1 
million 

€100,000 

€20,00085 

-€1 
million86 

-€900,000 

Table  30 :  Net  impact  of  CRE#4  (75%  emissions  reduction  target)  along  with  dental 
amalgam phase-outs, assuming no threshold, 203087 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 

2,000 
3,000 

3,000 
4,000 

– 

4,000 
5,000 

– 

>5,000 

Total 

In combination with 2025 dental amalgam phase-out 

€0 

€40,00089 

-€1 million 

-€1 million 

-€1 million 

-€1 million 

-€4 million 

Cost/benef
it estimate 

Mercury 
emissions 
reduction88 

82 Figures that are negative and presented in green font represent a benefit. 
83 Rounded to the nearest €100,000. 
84 Rounded to the nearest €100,000, unless otherwise stated. 
85 Rounded to the nearest €10,000 
86 Rounded to the nearest €1 million 
87 Figures that are negative and presented in green font represent a benefit. 
88 Rounded to the nearest €1 million. 
89 Rounded to the nearest €10,000. 

201 

 
 
 
                                                           
Cost/benef
it estimate 

Net 
impact90 

Mercury 
emissions 
reduction88 
Net 
impact90 

Mercury 
emissions 
reduction88 
Net 
impact90 

€0 

€0 

€0 

€0 

€0 

Crematoria in annual capacity band 
– 
<1,000 

- 

1,000 
2,000 
€100,000 

2,000 
3,000 
€1 
million78 

– 

3,000 
4,000 
€300,000 

– 

4,000 
5,000 
€200,000 

>5,000 

Total 

-€700,000 

€1 
million88 

In combination with 2027 dental amalgam phase-out 

€19,00091 

-€1 million 

-€1 million 

-€1 million 

-€1 million 

-€4 million 

€40,00092 

€1 
million78 

€200,000 

€100,000 

-€900,000 

€700,000 

In combination with 2030 dental amalgam phase-out 

€0 

€0 

-€1 million 

-€1 million 

-€1 million 

-€2 million 

-€5 million 

€1 
million78 

€200,000 

€20,00080 

-€1 
million78 

€300,000 

Measure CRE#5: National mercury reduction targets 

Assessment of economic impacts 

This measure concerns the implementation of national mercury reduction commitments, 
similar to those currently applied under the National Emissions reduction Commitments 
Directive  (NECD).  Reduction  targets  could  have  implications  for  mercury  emissions 
from sectors beyond just crematoria, and the exact impacts of such a commitment would 
depend  on  individual  Member  State  implementation  of  the  targets.  For  the  purpose  of 
assessing  impacts,  it  has  been  assumed  that  this  measure  would  increase  mercury 
emissions abatement uptake to 100% in Member States where no regulation is currently 
in  place.  Consequently,  the  number  of  impacted  installations  is  the  same  as  set  out  in 
CRE#2a, and the economic impacts are expected to be of the same scale. 

However,  in  practice  there  may  be  other  sectors  and  emission  sources  where  mercury 
emissions  could  be  reduced  more  cost-effectively  than  in  crematoria  thus  uptake  of 
abatement  may  be  much  lower.  To  estimate  where  emissions  could  be  reduced  more 
effectively,  an  in-depth  technical  assessment  of  emissions  and  abatement  options  and 
scenarios  (including  cost  analysis)  would  need  to  be  undertaken  using  an  integrated 
assessment  model,  similar  to  that  applied  previously  to  underpin  the  NEC  Directive 
revision.  

Assessment of social impacts 

The implementation of emission reduction targets is expected to have the same impact as 
CRE#2a (BAT and ELVs) in terms of abatement uptake. The impact in terms of emission 
reductions  will  therefore  also  be  the  same,  and  the  benefits  in  terms  of  human  health 
impacts will be the same as those described for CRE#2. 

Assessment of environmental impacts 

90 Rounded to the nearest €100,000, unless otherwise stated. 
91 Rounded to the nearest €1,000. 
92 Rounded to the nearest €10,000. 

202 

 
 
 
                                                           
Environmental  benefits  resulting  from  mercury  emissions  reductions  induced  by  this 
measure will be the same as those described for CRE#2a. 

203 

 
 
 
Problem  Area  3:  Manufacture  of  MAPs  for  export  to  third 
countries 
A  quantitative  assessment  of  the  impact  of  policy  options  was  only  possible  for 
fluorescent lamps. For this product, export data are available from the trade statistics of 
the  EU  (PRODCOM  split  by  CFL  and  double  capped  fluorescent  lamps)  and  the  UN 
(CONTRADE for all FL types). For all other products, quantitative data representing the 
whole market were unavailable. For these, only a qualitative analysis was performed. 

The  following  analysis  focuses  on  the  impacts  of  a  global  ban  on  the  production  and 
export of fluorescent lamps from the EU. These are, at least to a large extent, the subject 
of negotiations at the level of the Minamata Convention. Sufficient data are available for 
these  lamp  types  that  allow  a  quantitative  assessment  of  production  and  export  bans. 
According to information from manufacturers as well as available trade data, other lamp 
types (fluorescent lamps for special purposes, HID lamps) are of much lower relevance 
in  terms  of  trade  volume  and  mercury  content.  The  data  situation  is  much  worse  here. 
Existing  EU  instruments  address  only  a  minor  part  of  the  total  spectrum  of  lamps,  and 
aggregated trade data do not allow a detailed analysis of internally prohibited subtypes. 
However, the qualitative effects described in the following text on fluorescent lamps also 
apply in principle to the other lamp types and are therefore not explicitly repeated. 

If the EU further proceeds to support a global ban, an actual agreement at the MC COP 
remains  uncertain  and  the  impact  of  this  policy  measure  may  be  zero.  The  following 
analysis describes the impact a global ban would have if agreed to come into effect at the 
beginning of 2026/2028.  

Measure  MAP#1:  Aim  at  global  agreement  to  restrict  manufacture  and  export 
and subsequent implementation in EU law 

Assessment of economic impacts 

To  quantify  the  monetary  impact  of  a  global  ban,  lost  exports  are  accumulated  for  the 
years after a ban becomes effective within the EU (considered to be in the same year as 
determined  under  the  Minamata  Convention)  until  the  end  of  2030.  The  accumulated 
value  of  exported  FLs  is  dominated  by  sales  in  the  coming  few  years.  The  earliest 
possible year for a global ban would be 2026 and would affect only halophosphate LFLs 

Under a global ban scenario, EU exports of FLs would stepwise decrease to zero between 
2026  and  2030  (Figure  9).  The  accumulated  number  of  exported  FLs  would  be  167  to 
308  Mio  units  in  comparison  to  €412  to  €693  million  in  the  BAU2  baseline.  The 
calculated accumulated loss of export value would be €97 to €190 million between 2025 
and 2030 (Table 31). If it is not possible to gradually switch production to other products 
by  the  phase-out  date,  the  allocated  sales  would  cease  completely.  On  the  other  hand, 
demand for lighting products in general will not be affected by a global ban but instead is 
expected to increase (by about 4% annually). Thus, manufacturers have opportunities to 
compensate  for  losses  in  the  conventional  lighting  sector,  e.g.,  by  selling  LED 
lamps/luminaries  and  smart  lighting  systems.  A  look  at  the  export  figures  of  the  past 
years  shows  that  this  is  only  partially  successful  (UN  COMTRADE).  For  example, 
between 2017 and 2020, the value of discharge lamps exported from the EU fell by €145 
million (from €362 to €216 million), while the value of LED lamps exported increased 

204 

 
 
by only €101 million,  from  €101 to  €202 million. The overview may be incomplete as 
luminaires and lighting systems are not included here. 

The two production sites of fluorescent lamps (Erlangen, Piła) that will remain after the 
end  of  2022  are  in  different  stages  of  increasing  the  level  of  LED  production.  The 
remaining share of FLs in factory output is not known. At least for Erlangen, it has been 
reported that the focus is now on LED luminaires93. This corresponds to a decline of 85% 
in value of FLs exported from Germany between 2018 and 2021. On the other hand, FL 
exports  from  Poland  increased  by  about  10%  between  2018  and  202194.  It  has  been 
reported that FL production from another, now closed site in the USA has recently been 
relocated  to  Poland95  which  probably  contributed  to  stabilize  the  production  of 
conventional lamps at the Piła site.  

From  the  remaining  two  manufacturing  sites,  the  smaller  Erlangen  factory  would 
probably  face  relatively  low  impacts  as  the  conversion  to  LED  production  is  in  an 
advanced  state.  Production  at  the  Piła  site  is  much  more  significant  and  would  require 
considerable  investments  to  maintain  the  level  of  production  once  FLs  are  no  longer 
allowed  to  be  manufactured.  A  recent  study  provided  an  estimate  of  about  €15  to  €10 
million  conversion  costs  per  plant  (Erlangen  and  Piła),  although  the  rationale  of  this 
figure is not entirely clear96.  

Table 31: Impact of policy measures on exported lamps, their value and mercury content 

Scenario/ measure 

2025-

Exported 
units 
2030 
(million) 

Loss 
of 
export  value  
2025-2028 
(million €) 

in 

Mercury 
content 
exported 
lamps  
2025-2030 
(t) 

change 

of 
Net 
in 
mercury 
imported  lamps  in 
comparison 
to 
BAU2  (related  to 
exports) 
EU 
(t) 

93   Highlight Web (2022) Umsetzung der RoHS-Richtlinie bei Sylvania. https://www.highlight-

web.de/7105/rohs-aus-fuer-leuchtstofflampen-frueher-als-gedacht/ 

94   UN COMTRADE: from 156 to 169 Mio units 
95   EdisonReport (2020) Signify to Relocate Production and Close its Facility in Salina, Kansas. 

https://edisonreport.com/2020/08/13/signify-to-relocate-production-and-close-its-racility-in-salina-
kansas/ 

96   CLASP (2022) Refurbishing Europe’s Fluorescent Lamp Manufacturing Facilities. 

https://www.clasp.ngo/wp-content/uploads/2022/02/EU-Upgrading-Fluorescent-Manufacturing-to-
LED-Report.pdf 

205 

 
 
                                                           
BAU2 

412 – 693 

0 

1.21 – 2.17 

0 

MAP#1 Global ban 
2026/2028 

MAP#2a EU ban 
2025 

MAP#2b EU ban 
2026/2028 

EU ban 2026/2028 
followed by a global 
ban 2026/2028 

EU ban 2026/2028 
followed by a global 
ban 2028/2030 

167 – 308 

97 – 190 

0.41 – 0.72 

-1.50 - -0.92 

0 

191 – 347 

0 

-0.53 – 1.59 

167 – 308 

97 – 190 

0.41 – 0.72 

-0.32 – 1.12 

167 – 308 

97 – 190 

0.41 – 0.72 

-1.50 - -0.92 

167 – 308 

97 – 190 

0.41 – 0.72 

-0.53 - -0.23 

Figure 9: Predicted FL exports 2025- 2030 under different scenarios 

206 

020406080100120140160202520262027202820292030Mio unitsYearExported FLs 2025-2030EUunilateral 2025EU unilateral 2026/2028 min/Global ban 2026/2028 min 
 
 
 
Figure 10: Accumulated loss of export value for fluorescent lamps until the end of 2030 in 
case of a global or an EU export ban (MAP#1, MAP#2a, MAP#2b) in comparison with the 
BAU2 baseline (55% halophosphate in double-capped FL) 

SMEs  would  not  be  affected  by  an  export  ban  for  FLs  since  both  remaining 
manufacturers  belong  to  large  company  groups.  Little  administrative  burden  would  be 
put on business because the ban would lead to a complete closure of production lines. 

A global ban would have little impact on competitiveness since all main manufacturing 
countries worldwide are affected in the same way. However, some countries are not Party 
to the Convention and others may opt to postpone application of newly listed product by 
five years (opt-out) or not apply the ban at all until a national decision is taken (opt-in). 
These markets would become unavailable for European manufacturers while non-Parties 
may increase sales. Among the main importing countries are Egypt, Russia, and Turkey 
that  receive  25%  of  European  exports  (due  to  the  Russian  invasion  of  Ukraine,  lamp 
exports to Russia have partly stopped in spring 2022. It is not clear if and when they may 
resume97). Opt-out countries such as India may export higher amounts of lamps to such 
states  at  least  for  a  couple  of  years  until  the  general  decrease  of  demand  will  diminish 
exports again.  

The number of affected employees can be estimated only roughly. At the Erlangen site 
that  already  converted  its  production  largely  to  LEDs,  about  200  employees  are 
working98. Only a small share is considered to be directly involved in the FL production. 
The  current  number  of  employees  at  the  Piła  site  is  unknown.  Data  from  publicly 
available databases indicate that the total number of employees of Signify in Poland was 
around 3,000 in 2016. Which part of this staff can be attributed to FL production in Piła 

97   Eindhoven Dagblad (2022) Eindhovens lichtbedrijf Signify staakt export naar Rusland. 

https://www.ed.nl/eindhoven/eindhovens-lichtbedrijf-signify-staakt-export-naar-rusland~a3b21be2/?r 

98   Elektro.at (2020) Feilo Sylvania Germany flüchtet in Schutzschirm-Verfahren. 

https://elektro.at/2020/02/04/feilo-sylvania-germany-in-schutzschirm-insolvenz/ 

207 

050100150200250300350400202520262027202820292030Mio €Year the measure entries into forceAccumulated loss of export value until the end of 2030 
 
 
                                                           
cannot be estimated. But if it is assumed that in 2020 50% of the staff in Erlangen (100 
from 200 total) was still involved in FL production and about 50% of the production was 
exported99 (15 million units, 50 employees) then the output of 170 million Units in Piła 
would require roughly a tenfold number (around 500). The number of current employees 
is  expected  to  decrease  even  without  a  ban.  A  global  ban  becoming  fully  effective  in 
2028 would affect approximately 40-56% of the export volume of 2020 and probably the 
same share of the remaining workforce. 

The end of FL production would also have an indirect impact on the European logistics 
centres as well as on suppliers of components (e.g., ballasts, glass tubes). The numbers of 
employees in wholesale/ logistics that would be affected is considered small in relation to 
the  employees  directly  involved  in  the  production  (around  10%100).  As  the  demand  for 
lighting  products  in  general  is  expected  to  increase101,  also  because  there  is  a  need  to 
replace  old  lamp  types  and  luminaires,  the  global  overall  net  effect  on  employment  is 
expected to be positive. In the EU, however, this trend is likely to compensate only part 
of  the  loss  of  employment  as  about  60-70%  of  LED  related  jobs  (especially  for  the 
production  of  LED  components)  is  located  outside  the  EU.  Therefore,  even  if  EU 
manufacturers  could  mostly  replace  current  FL  exports  by  exports  of  LED  lamps  and 
luminaires, the need for employees at EU factories could be lower due to the lower real 
net output ratio.  

For Europe, average costs for replacement of T5 and T8 luminaires were estimated to be 
in the order of €231 and €186, respectively102. Outside the EU, costs will vary according 
to  national  requirements  and  labour  costs  but  will  remain  significant.  No  attempt  was 
made to calculate replacement costs in individual markets. 

A  global  ban  on  other  mercury-containing  lamps  (HID,  other  low  pressure  discharge 
lamps) would have a limited impact. If HID lamps in the order of 8% became subject of a 
ban  in  2028,  about  3  million  lamps  with  a  value  of  about  €25  million  could  not  be 
exported  between  2028  to  2030.  That  is  less  than  the  typical  annual  fluctuation  in 
exports.  The  market  for  these  lamp  types  is  much  more  heterogenous  with  a  larger 
number of manufacturers, including SMEs. Due to the limited impact on the market as a 
whole, no further analysis of specific impact on SME was conducted.  

Impact on public authorities, consumers and households 

As  a  global  export  ban  would  mainly  affect  manufacturers  and  distributors,  little  to  no 
impact is expected for public authorities, consumers and households. 

Assessment of environmental impacts 

99   The ratio of exported and produced FL lamps was about 53% between 2016 and 2020 (EU 
PRODCOM) 
100  European Commission (2019) Commission staff working document. Impact assessment. Commission 
Regulation (EU) .../... laying down ecodesign requirements for light sources and separate control gears 
pursuant to Directive 2009/125/EC of the European Parliament and of the Council 

101   Zissis et al. (2021) Update on the Status of LED-Lighting world market since 2018. JRC Technical 

Report. EUR 30500 EN 

102  Öko-Institut e.V., Institute for Applied Ecology, and Fraunhofer-Institut for Reliability and 

Microintegration (IZM) (2019) Study to assess socio-economic impact of substitution of certain 
mercury-based lamps currently benefitting of RoHS 2 exemptions in Annex III 

208 

 
 
                                                           
A global ban on fluorescent lamps for general lighting purposes would primarily result in 
less  mercury  being  needed  within  the  European  Union  for  the  production  of  discharge 
lamps. To the same extent, the mercury content of exported lamps would decrease. With 
a ban taking effect in 2026/2028, this would affect a quantity of 0.8 to 1.5 t of mercury in 
the period 2026-2030. Given the low recycling rates, about  85% of this amount (0.7  to 
1.3 t) would not enter the general waste stream and, at least in some importing countries 
would  not  contribute  to  a  contamination  of  soil  and  the  emission  of  mercury  into  air. 
After  the  ban  of  other  products,  fluorescent  lamps  are  now  the  most  relevant  MAP  for 
consumers  (beside  dental  amalgam).  Eliminating  FLs  and  other  mercury-containing 
lamps from circulation in the society would remove one of the most important sources of 
product-related mercury contamination in many importing countries. 

Replacing FLs with  LED retrofit lamps or LED luminaires results in significant energy 
saving.  The  degree  depends  on  the  individual  solution  found  at  each  installation  point, 
operating  conditions  and  the  use  pattern  (e.g.,  residential,  non-residential).  It  cannot  be 
easily  calculated  on  a  global  scale.  The  lowest  values  are  typically  experienced  with 
retrofit lamps the highest with smart LED lighting systems. For example, replacing CLFs 
with  LED typically led to energy savings in  the order of 25-40% in  residential  settings 
and  up  to  52%  in  commercial  buildings.  Considerably  higher  energy  savings  of  up  to 
70% and more were reported for smart lighting systems103.  

No  attempt  was  made  to  precisely  predict  global  energy  savings  due  to  the  high 
uncertainties but to get an idea of the order of magnitude the following calculation was 
performed: 

  For  simplicity  it  assumed  that  all  sold  lamps  are  32W  T8  LFLs  with  an  annual 

operation time of 2200 h104 and a lifetime of 20000 h (about 9 years) 

 

in 2028 (the earliest considered year, where all FLs could be banned globally) the 
number of sold lamps is predicted to be 65 to 109 Mio units (BAU2). 

  The total annual energy consumption of these lamps in 2028 would be 4.6 to 7.7 
TWh. For comparison, total energy consumption for lighting is estimated to be at 
2900 TWh per year. 

 

If replaced by LEDs and assuming an energy saving of 25 to 40% per lamp, the 
energy saving would be in the order of 1.1 to 3.1 TWh in that year 

  Energy  savings  would  accumulate  during  the  following  years  as  more  FLs  are 
replaced.  Within  a  typical  lifetime  of  a  new  LFL  T5  the  total  energy  savings 
would be in the order of 10 to 28 TWh. Considering a carbon intensity of 475 g 
CO2/ kWh105 this would result in a lifetime saving of about 5 to 13 Mt CO2. 

This  is  only  a  rough  calculation  for  the  impact  of  global  ban  would  have  in  2028.  A 
similar but slightly smaller effect would have to be added for each following year as the 
predicted but decreasing FL sales are substituted by LED. Consequently, the cumulative 

103 Soheilian, M.; Fischl, G.; Aries, M. (2021) Smart Lighting Application for Energy Saving and User 
Well-Being in the Residential Environment. Sustainability 13, 6198 
104 VITO (2015) Preparatory Study on Light Sources for Ecodesign and/or Energy Labelling Requirements 

(‘Lot 8/9/19’). Final report, Task 3. Use of Light Sources 

105 IEA (2019) Global Energy & CO2 Status Report 2019.  https://www.iea.org/reports/global-energy-co2-
status-report-2019 

209 

 
 
                                                           
effect of a ban becoming effect in 2026/2028 would be multiple times this value. It must 
be stressed that this calculation only addresses EU exports.  

Assessment of social impacts 

A global ban would lead to the phase-out of more than 90% of the remaining production 
of  mercury-containing  lamps,  thus  removing  mercury  as  a  hazard  from  several 
production  lines  and  many  workplaces.  It  is  understood,  however,  that  working 
conditions at European manufacturing sites already reduce the risks of mercury exposure 
to  a  minimum  (e.g.,  by  automated  dosing)  so  that  the  improvement  of  actual  working 
conditions  would  be  limited.  Besides  that,  no  further  social  impacts  for  citizens  within 
the EU were identified. 

For  citizens  in  importing  countries  the  phase-out  of  mercury-containing  lamps  would 
eliminate the most important source of product-related mercury exposure. New input of 
mercury in general waste would be avoided, so that population that is working with waste 
(e.g.,  waste  pickers)  or  is  living  near  waste  dump  sites  has  a  lower  risk  of  getting  in 
contact with mercury. 

Measure MAP#2(a and b): EU legal ban on MAP manufacture and export 

Assessment of economic impacts 

Mercury-containing lamps 

A  European  export  ban  would  prevent  exports  of  MAPs  to  third  countries  unilaterally. 
Two variants of such a ban are considered here: 

  MAP#2a:  Export  ban  from  2025  for  all  MAPs  for  which  the  placing  on  the 

market within the EU is already prohibited by that time. 

  MAP#2b: Gradual export ban based on the earliest deadlines under discussion in 

the negotiations at the Minamata Convention (COP5) level: 

o  2026: Halophosphate LFL ≤40 W 

o  2028: Triband LFL <60 W as well as all other MAPs (yet to be proposed 

by the EU or other Parties). 

In  the  context  of  this  analysis,  as  before,  only  exports  of  fluorescent  lamps  for  general 
lighting purposes are discussed in a quantitative manner. 

According  to  the  first  variant,  all  exports  would  end  from  2025,  so  that  412  to  693 
million FLs would not be exported. Their accumulated export value in the period 2025 to 
2030 is 191 to €347 million (Table 31, Figure 9). With a ban only in 2026/2028, 167 to 
308  million  units  could  still  be  exported  and  the  loss  would  decrease  to  €97  to  €190 
million,  the  majority  of  which  (78%)  can  be  attributed  to  double-capped  fluorescent 
lamps. The impact on employment would be slightly higher in case of an export ban in 
2025  as  the  measure  takes  effect  some  years  earlier  than  a  global  export  ban  but 
otherwise  it  is  expected  to  be  in  the  same  order  of  magnitude.  For  an  export  ban  in 
2026/2028 the effect would be the same as estimated for a global ban. 

The announcement of an EU ban would likely lead to increased production and export in 
the time directly before the phase-out date. On the one hand, users may like to increase 
their  stocks  before  EU  supply  is  no  longer  available.  On  the  other  hand,  distributors 
outside  the  EU  are  confronted  with  continuing  demand  for  EU  made  lamps  may  also 

210 

 
 
increase  their  stocks  to  provide  such  lamps  after  the  export  ban  has  entered  into  force. 
This extra demand is mainly limited by available shelf space, the costs for bound capital 
and the expectations regarding future sales. Such effects have been observed on the lamp 
market  before106  and  are  likely  to  repeat  again,  however  the  effect  cannot  be  reliably 
quantified.  

In  this  context,  industry  stakeholders  suggested  that  lamps  that  have  previously  been 
legally imported by distributors for the purpose of re-export should be exempted from an 
export ban. Alternatively, an import ban could precede the export ban with a time lag in 
order to accelerate the reduction of stocks. 

If it is assumed that around 8% of the current HID lamp exports would be affected by an 
export  ban,  about  6  million  units  of  HID  lamps  could  not  be  exported  within  2025  to 
2030. Their value is at approximately €55 million. An export ban in 2028 would reduce 
HID lamps exports by about 2.8 Mio units until 2030 (foregone revenues would be about 
26 Mio. €). 

An EU  export measure  would impair the competitiveness  of EU manufacturers as they 
are  cut  off  from  markets  manufacturers  from  third  countries  still  have  access  to.  EU 
manufacturers for fluorescent  lamps  belong to  larger company  groups that  may  at  least 
partially shift production capacities to factories outside the EU. This does not necessarily 
apply to SMEs that are producing other lamp types. However, as said before only a small 
fraction of HID exports is affected and the relocation of production capacities may not be 
necessary. 

The  effect  on  employment  for  FL  production  would  be  like  that  described  for  MAP#1 
(global ban). In the case of a later export ban, the value would likely be lower as exports 
and  thus  employment  linked  to  these  exports  are  expected  to  decrease  even  without  a 
ban.  The  major  difference  would  be  that  EU  manufacturers  could  not  count  on  a 
corresponding higher demand for LED products, as the demand for lamps would at least 
in  part  be  met  by  FL  exports  from  other  countries.  Accordingly,  compensating 
employment for LED production would be lower than in the MAP#1 scenario. 

Dental amalgam 

According to observed global trends, demand for dental amalgam and exports from the 
EU are likely to decrease. An EU export ban from the EU would accelerate this process. 
All  four  identified  manufacturers  that  have  not  yet  announced  an  exit  from  the  market 
belong  to  SMEs.  According  to  publicly  available  information,  the  total  turnover  of  all 
companies is around €40 million and the number of employees around 200. Only part of 
these sums is attributable to the manufacture and sale of dental amalgam. Two of these 
companies  specialize  to  a  large  extent  in  dental  amalgam.  They  also  offer  other  dental 
products,  but  no  other  filling  materials  (Global  Dental  Trade,  World  Work  Srl). 
Depending  on  the  relevance  of  the  amalgam  business,  a  manufacturing  and  export  ban 
could result in a significant reduction in sales and employment.  

Based on the estimates in this study, in 2025 about 13 to 55 million amalgam capsules 
will  be  exported.  At  a  retail  price  of  about  €1  per  capsule,  the  retail  value  of  exported 

106  For example low pressure sodium lamps (SOX) that  went out of production in 2019. See: Lamptech 
(2020)  Philips  Hamilton  Factory  http://www.lamptech.co.uk/Documents/Factory%20-%20UK%20-
%20Hamilton.htm 

211 

 
 
                                                           
capsules  would  be  about  €13  to  €55  million.  An  export  ban  in  2025  would  affect 
predicted sales with a total retail value of about €50 – €300 million in the period 2025-
2030. If export is phased-out only in 2027 the loss of sales would amount to €30 – €200 
million  in  2027  to  2030.  Because  of  the  costs  in  the  intermediate  trade,  the 
manufacturers’ sales value is considerably lower. 

Assessment of environmental impacts 

Mercury-containing lamps 

An EU export ban from 2025 would avoid the use of about 1.21 to 2.17 t of mercury in 
European lamp products between 2025 and 2030. About 85% of this amount or 1.0 to 1.9 
t  would  not  enter  the  general  waste  stream  in  importing  countries.  With  an  export  ban 
from 2026/2028, the mercury content in exports would decrease by 0.8 to 1.5 t (Table 31) 
and the mercury input into general waste by 0.7 to 1.3 t. However, this is countered by 
the  amount  of  mercury  contained  in  fluorescent  lamps  that  are  imported  instead  of 
European lamps. This assessment considers a level of substituting imports in the range of 
50 to 90%. Higher values were expected by industry representatives and cannot be ruled 
out, but some probable market effects speak against this (including stockpiling before an 
export  ban  becomes  effective,  price  increases  due  to  lower  competition,  political 
imitation  effects,  non-availability  of  technically  equivalent  competing  products).  Low 
values  significantly  below  50%  were  expected  by  other  stakeholders  and  cannot  be 
completely dismissed either. However, the availability of technically equivalent products, 
at least for mainstream lamps from non-European manufacturers, suggests that a halt to 
European exports is not associated with a sudden collapse in demand. This is all the more 
true  as  the  challenges  of  switching  to  LED  lamps  or  luminaires  remain  unchanged 
(including high initial costs when rewiring or luminaire replacement becomes necessary, 
lack  of  availability  of  trained  personnel,  lack  of  retrofit  products).  The  shorter  the 
changeover period, the more likely it is that FL imports from other countries will be used 
as a substitute, as users have less time to adapt to alternative solutions in organisational 
and financial terms. 

In  addition,  non-European  FLs  have  a  significantly  higher  average  mercury  content 
(Table  32).  While  the  difference  for  CFL.ni  lamps  is  often  only  small  and  amounts  to 
only  a  few  tenths  of  a  milligram,  the  difference  for  FL  lamps  and  there  especially  for 
halophosphate lamps is higher (3 to 5 mg per lamp). Since halophosphate LFLs account 
for about half of LFL exports and LFLs in turn account for 77% of all FL exports, this 
difference is reflected in the overall balance. 

Table  32:  Medium  mercury  content  of  fluorescent  lamps  made  in  the  EU  and  in  third 

countries 

Lamp type 

the 

in 

Made 
EU 
[mg Hg / lamp] 

Made  in  third 
countries 
[mg Hg / lamp] 

CFL 

1.8 

2.1 – 2.8 

212 

 
 
LFL triband 

1.7 – 1.9 

2.6 – 3.2 

LFL halophosphate 

5 

8 – 10 

Source:  Published  data  from  manufacturers  in  the  EU  and  third  countries  on  the  mercury 
content of CFL and LFL subtypes weighed with their EU market share (only CFL and triband LFL) 
107 

Against this background, the volume of substituting imports was first calculated and then 
the amount of mercury contained in these imports. For the scenario of an export ban from 
2025, the substitute FLs would have a mercury content that is 0.53 t lower but can also 
be  1.59  t  higher  (Figure  11).  The  low  values  of  this  range  are  only  realised  when  low 
substitution rates and low mercury contents in substituting imports coincide. The range is 
smaller if an export ban is considered from 2026/2028 (-0.32 to 1.12 t).  

Looking  at  global  market,  total  sales  (and  trade)  are  expected  to  further  decrease. 
Therefore,  any  potential  short-term  increase  of  the  total  mercury  content  in  lamps 
imported by third countries is compensated within a couple years by the overall trend of 
decreasing usage of fluorescent lamps. 

A decision by the EU is not detached from further negotiations at the international level. 
If the European export ban and a global ban coincide in 2026/2028, the effect is equally 
positive as if there had only been a global ban (-1.50 to -0.97 t). Should the global ban 
occur  two  years  later  (2028/2030),  the  net  effect  is  still  positive  (-0.57  to  -0.24  t),  as 
substitute imports could only occur for a maximum period of two years. 

For  HID  lamps  the  environmental  impact  is  expected  to  be  limited.  Due  to  the  low 
number of exports and the small fraction of lamps that are prohibited within the EU, the 
total mercury content in relevant exported lamps may be in the order of 20 kg only. 

Due to the issue of substituting imports, supply of mercury-containing lamps would not 
be completely cut and input into the general waste stream would pertain, probably with a 
lower  number  of  lamps.  Based  on  the  considerations  above,  the  input  may  decrease  or 
increase, at least if only imports from the EU and substituting imports are considered.  

107 Lighting Europe (2020); Request to renew Exemptions 1(a, b, c, e) / Request to renew Exemptions 1(g) 
and  2(a)5  /  Request  to  Request  to  renew  Exemptions  2(a)(2),  2(a)3,  and  2(b)3  /  Request  to  renew 
Exemptions 2(a)(2), 2(a)3, and 2(b)3 

213 

 
 
                                                           
Figure  11:  Accumulated  net  change  of  mercury  content  in  imported  FLs  (related  to  EU 

exports) 

Dental amalgam 

In  the  case  of  an  export  ban  in  2025,  the  mercury  content  of  exported  dental  amalgam 
would decrease by approximately 30 to 180 t in the years 2025 to 2030. A later phase-out 
(2027) would result in a decrease of 20 – 120 t. The reduced exports, if not substituted by 
dental amalgam supply from other countries would result in reduced mercury releases to 
air  and  soil  in  the  same  order  of  magnitude.  In  the  absence  of  national  legislation  or 
standards, demand from  patients  and practitioners is  likely to  remain  at  a similar level. 
The demand would then be met by manufacturers outside the EU that are able to provide 
dental  amalgam  capsules  with  similar  characteristics.  Among  them  are  one  or  two 
manufacturers  that  have  recently  relocated  their  production  from  the  EU  to  third 
countries.  However,  the  lower  number  of  competitors  may  lead  to  higher  prices  and 
making  mercury-free  alternatives  more  attractive  for  those  who  are  able  to  pay  for  the 
price  difference.  Others  may  opt  for  cheaper  but  less  durable  treatments  (e.g.,  glass 
ionomers) or extraction. The summary effects cannot be reliably predicted, but overall, it 
may  be  expected  that  total  supply,  use  of  dental  amalgam,  mercury  consumption  and 
mercury releases stay at the same or a slightly lower level. The net environmental impact 
of an EU ban is expected to be close to zero or slightly positive. 

Assessment of social impacts 

Mercury-containing lamps 

In  principle  the  same  impacts  as  discussed  under  ‘global  ban’  would  apply.  But  in 
contrast  to  a  coordinated  global  approach,  mercury-containing  lamps  would  still  flow 
into  the  markets  and  circulate,  so  that  the  threat  of  mercury  contamination  of  land  and 
mercury emissions to air is not eliminated. There are scenarios that lead to a decrease of 
mercury  input  into  the  society,  thus  reducing  the  risk  of  exposure  and  contamination. 

214 

-1500-1000-5000500100015002000Global ban2026/2028Unilateral ban 2025Unilateral ban2026/2028Unilateral ban2026/2028 + Global2026/2028Unilateral ban2026/2028 + Global2028/2030Change of imported total Hg in realtion to BAU-2 [kg]Halo 50% Triband 50% 
 
 
Other  scenarios  could  lead  to  increased  mercury  amounts  because  of  imports  with  a 
higher mercury content. Such negative impacts are limited to a couple of years until the 
predicted decrease of sales compensates a possible short-term effects or measures on the 
national or global scale to ban of imports from all countries. 

According to feedback from an industry association, lamps no longer produced in the EU 
may be replaced in  the markets  by mercury-containing lamps manufactured outside the 
EU under likely lower health and safety standards. 

Dental amalgam 

In  case  of  an  EU  ban  on  dental  amalgam  export,  access  of  practitioners  to  dental 
amalgam could become more difficult. This affects mainly those markets that currently 
receive  most  exports.  According  to  information  from  one  manufacturer,  these  are  low-
income countries in North Africa, the Middle East and Asia. No information is available 
on  the  supply  situation  in  these  countries  so  that  it  is  not  clear  whether  alternative 
suppliers from other global regions could step in to meet the demand. The situation may 
get more complicated in the future because there is a decline of the number of worldwide 
amalgam manufacturers (for example, two major US companies have recently announced 
to stop amalgam production). Moreover, market  entry of new providers may be slowed 
by registration / authorization procedures.  

However, according to available information, there are several manufacturers outside the 
EU left, that in principle could sustain supply with dental amalgam capsules.  

As a consequence, there may occur situations in third countries where amalgam supply 
becomes  insufficient  or  available  only  at  higher  prices.  In  that  case,  practitioners  may 
have no achievable, equally effective  filling options to  treat  their patients  – composites 
cannot be applied by all practitioners because they lack the necessary equipment and/or 
training while other materials such as glass ionomers have a lower lifetime and are not 
suitable  for  all  cavities.  An  EU  export  ban  for  dental  amalgam  may  therefore  have  a 
negative impact on dental care in certain countries and impair their autonomy to organize 
the health systems according to their self-defined priorities. 

Measure  MAP#2c:  EU  legal  ban  on  MAP  manufacture  and  export  and 
administrative /scientific support for importing third countries 

Assessment of economic impacts 

Cooperation  with  importing  countries  can  help  to  create  a  level  playing  field  for  all 
market participants, so that substitute MAP imports from third countries are reduced or 
eliminated.  In  principle,  all  countries  that  import  MAPs  from  the  EU  are  eligible  for 
cooperation and support programmes. Of particular importance are discharge lamps and 
dental amalgam. The greatest effect is achieved when cooperation focuses on countries or 
groups of countries with relevant import volumes. The success of a cooperation depends 
on various factors. First, the willingness of the respective country to cooperate with the 
EU  on  MAP  issues  has  to  be  won.  Secondly,  sufficient  time  and  commitment  on  both 
sides are necessary to find solutions that are in line with the priorities and approaches of 
the respective country. Furthermore, depending on the type of approach, time is needed 
to  codify  the  solution,  whether  through  legal  instruments,  standards,  or  incentive 
programmes. Years can pass between the start of outreach and a measure taking effect.  

215 

 
 
The  strong  support  from  Parties  for  the  phase-out  periods  recently  discussed  at  MC 
COP4 shows that many countries are willing to phase out the use of discharge lamps. It 
can  therefore  be  expected  that  the  interest  in  cooperation,  which  ultimately  also  serves 
the  implementation  of  the  Minamata  Convention,  is  relatively  high.  This  should  also 
apply  to  countries  that  have  expressed  reluctance  or  are  not  parties  to  the  Convention 
(e.g., Egypt, Turkey, Iran), because no fundamental opposition, e.g. to the use of energy-
saving lamps, has been voiced so far.  

The established programmes and cooperation formats (see above) offer a good basis for 
initiating  and  deepening  cooperation.  To  what  extent  and  when  such  bilateral  activities 
lead to effective national policies is difficult to assess – empirical values are not available 
here.  Such  activities  could  make  an  important  contribution  to  avoiding  or  at  least 
reducing the unintended negative effects of EU export bans. Regarding further product-
related regulations – the RoHS directive lists nine other substances banned in electrical 
products  in  addition  to  mercury  –  cooperation  is  also  of  interest  in  the  long  term.  The 
achievement of European environmental goals, as outlined in the European Green Deal, 
cannot  be  achieved  in  isolation,  but  only  in  partnership  with  other  countries.  For  this 
reason, cooperation on the topic of MAPs can play a pioneering role here and open doors 
that can be used for other focal points of European environmental policy. 

The cooperation programmes would have no direct impact on companies and employees, 
as  they  are  only  meant  to  complement  an  EU  export  ban.  However,  if  successful  they 
would  open  opportunities  for  European  lighting  companies  to  increase  sales  of  LED 
systems in partnering countries as these need to replace FL based lamps and luminaires. 

There is  a limited, unquantified burden on those European and national  authorities that 
actively participate in collaborations. It is assumed that the contribution is made in-kind 
and  incurs  only  limited  additional  costs.  Limited  funding  is  required  to  support 
programmes such as U4E or projects such as the Specific International Programme. The 
amount depends on the level of participation desired and cannot be estimated. 

Assessment of environmental impacts 

The quantitative impact of cooperation and support programmes cannot be estimated. It 
should  be  borne  in  mind,  however,  that  the  time  required  between  a  measure  being 
initiated  and  becoming  effective  can  quickly  span  several  years,  as  can  be  seen,  for 
example,  from  legislative  procedures.  In  the  case  of  a  relatively  short-term  export  ban, 
e.g.,  a  ban  adopted  at  the  end  of  2023  and  taking  effect  at  the  beginning  of  2025,  it  is 
doubtful that results from other countries will already be available at the beginning of the 
ban.  To  be  able  to  use  the  instrument  meaningfully,  it  must  be  coordinated  with  the 
envisaged export ban. A few years’ lead time seems appropriate here. 

However,  based  on  the  projections  of  the  net  change  in  mercury  content,  it  can  be 
determined  by  back-calculation  that  addressing  e.g.,  20%  of  the  export  volume  is 
sufficient to halve the maximum possible negative effect caused by substituting imports. 
Measures  in  one  or  two  of  the  most  important  trading  partners  would  be  sufficient  to 
achieve this. 

A side-effect of such activities would be energy-savings, medium-term cost savings and 
less  CO2  emissions  in  the  partnering  countries.  They  would  be  proportional  to  the 
number of lamps not imported from third countries. 

216 

 
 
Assessment of social impacts 

The measures do not have a social impact in the EU. 

Measure MAP#3: Prior Informed Consent (PIC) procedure for dental amalgam 

Economic impacts 

A  PIC  procedure  would  give  importing  third  countries  the  possibility  to  prevent  direct 
imports from the EU. However, it is not possible to estimate which third countries may 
choose to disagree with future imports and what share of current exports may be affected 
by such decisions. 

Administrative  burden  on  businesses  and  public  authorities:  Impacts  may  be  expected 
for  public  authorities  and  companies  that  are  concerned  with  a  PIC  procedure  to  allow 
exports.  Furthermore,  such  an  option  would  require  amending  the  existing  PIC 
Regulation108 which currently does not provide for PIC procedure for MAPs but simply 
requires  exporters  of  MAPs  to  submit  an  export  notification  to  their  competent 
authorities. Such an amendment to the PIC Regulation would imply the implementation 
of a prior informed consent procedure whereby a significant burden on the exporter and 
its  competent  authority  but  also  on  importing  third  countries  (information  exchange, 
formal consent for export and import etc.). 

Environmental impacts 

The direct environmental effect of the PIC procedure is all but certain as it will depend 
on  third  countries’  willingness  to  prohibit  the  import  of  EU-made  dental  amalgam. 
Should third countries not be pro-active in their objectives to eliminate dental amalgam 
use, exported volumes may remain high and yield low environmental benefits. 

Social impacts 

The measure would have no social impact in the EU but could avoid unwanted exports of 
mercury  to  third  countries  and  a  decrease  of  mercury  input  into  waste  streams,  should 
those countries show political willingness as well as administrative capacities to handle 
burdensome prior informed consent procedures.  

108  Regulation (EU) 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning 

the export and import of hazardous chemicals (OJ L201, 27.7.2012, p. 60). 

217 

 
 
 
                                                           
Discarded policy measures and rationale 
The  initial  screening  of  the  long  list  of  policy  measures  has  been  carried  out  using  the 
screening criteria defined in the BR Tool#16: 

  Legal feasibility: Options should respect the principle of conferral. They should also 
respect  any  obligation  arising  from  the  EU  Treaties  (and  relevant  international 
agreements) and ensure respect of fundamental rights. Legal obligations incorporated 
in existing primary or secondary EU legislation may also rule out certain options. 

  Technical feasibility: Technological and technical constraints may not allow for the 

implementation, monitoring and/or enforcement of theoretical options.  

  Previous policy choices: Certain options may be ruled out by previous Commission 

policy choices or mandates by EU institutions. 

  Coherence with other EU policy objectives: Certain options may be ruled out early 

due to poor coherence with other general EU policy objectives. 

  Effectiveness and efficiency: It may already be possible to show that some options 
would incontrovertibly achieve a worse cost-benefit balance than some alternatives. 

  Proportionality:  Some options  may  clearly  restrict the scope for national  decision-

making over and above what is needed to achieve the objectives satisfactorily. 

  Political feasibility: Options that would clearly fail to garner the necessary political 

support for legislative adoption and/or implementation could also be discarded. 

  Relevance: There is no point in retaining options that do not address the needs of the 

policy intervention as identified in the problem definition.  

  Identifiability:  When  it  can  be  shown  that  two  options  are  not  likely  to  differ 
materially in terms of their significant impacts or their distribution, only one should 
be retained. 

The initial screening of the longlist of policy measures and those that were discarded at 
an early stage is set out in Table 33 along with the rationale for their exclusion. 

Table 33: Discarded policy measures rationale (initial screening of long list) 

Policy measure 

Rationale for exclusion 

1. Removal of dental amalgam pre-cremation 

2.  Voluntary  agreement  by  lamp  manufacturers  to 
phase  down  the  production  of  mercury  containing 
lamps by specific dates 

The  removal  of  dental  amalgam  pre-cremation  was 
deemed  inappropriate  for  action  at  EU  level  due  to 
sensitivity issues and the likely burden on crematoria 
operators  to  implement  this,  requiring  expertise  and 
time for the removal. 

Choosing  a  voluntary  approach  would  be  in  strong 
contract  to  previous  EU  Conclusions  that  only 
mandatory  approaches  are  effective  enough 
to 
address the production and trade of MAPs. Moreover, 
loopholes  and 
the  approach  would  open 
advantages  for  market  participants  that  do  not 
participate in the agreements. 

legal 

218 

 
 
Policy measure 

Rationale for exclusion 

3.  Extended  producer  responsibility  by  requiring 
Industry-led measures to improve the management of 
hazardous  mercury  containing  lamps  in  importing 
countries (outside the EU) 

4.  Establishment  of  Prior-Informed  Consent  (PIC) 
procedure for mercury containing lamps 

5.  Export  duty  on  relevant  mercury-added  products 
(MAPs) 

6.  Raising  awareness  about  mercury  content  and 
potential hazard of MAPs 

7.  Reducing 
manufactured and exported MAPs 

the  allowed  mercury  content 

in 

The EU has no means to ensure implementation or to 
monitor  the  results  of  these  measures,  considering 
they  take  place  outside  of  the  EU  and  its  market. 
in  waste 
improvements 
Experience  shows 
require 
slow 
are 
management 
considerable resources. Hence, this option is unlikely 
to be effective.  

systems 

that 

and 

PIC  sets  a  prior  informed  consent  procedure  for  the 
substances  and  articles 
export  of  hazardous 
containing  such  substances,  which  does  not  amount 
to an outright prohibition. PIC sets export bans in its 
Annex  V  only  once  such  bans  are  already  set  out  in 
the  Mercury 
other  EU 
Regulation. Such amendments to Annex V to PIC are 
developed  for  consistency  purpose  across  applicable 
Union legislation.   

instruments,  such  as 

This  measure  would  only  have  a  limited  effect  on 
demand  in  importing  third  countries  and  export 
would still be allowed. Moreover, this measure would 
incur significant additional administrative costs. 

This measure was not considered feasible on a global 
scale,  incurring  high  costs  and  resulting  in  low 
effectiveness. 

This  measure  would  not  reduce  EU  exports.  On  the 
global scale, it would be a political backward step as 
the EU has been a proponent with other Parties to the 
Minamata Convention to a full ban of such products. 

Following  inter  service  consultation  within  the  Commission  as  well  as  discussion  with 
the  RSB,  a  number  of  policy  measures  /  options  considered  within  the  initial  impact 
analysis  (and  documented  in  this  annex)  were  discarded  and  not  considered  further 
within the SWD. These are described in Table 34.  

Table  34:  Discarded  policy  measures  rationale  (discarded  at  a  later  stage  and  not 

considered further in the SWD) 

Policy measure 

Rationale for exclusion 

219 

 
 
 
Policy measure 

Rationale for exclusion 

including 

the  allocation  of 

the  Member  States  for 
their  health  policy  and  for 

The  EU  has  a  limited  competence  in  the  field  of 
public  health  and  is  not  entitled  to  act  as  a  price 
regulator,  i.e.,  Union  action  needs  to  respect  the 
the 
responsibilities  of 
definition  of 
the 
organisation  and  delivery  of  health  services  and 
medical  care, 
the 
resources  assigned  to  them.  Hence,  whereas  the 
option consisting of  reducing the difference between 
the  social  security  reimbursement  rates  for  dental 
amalgam  and  mercury-free  filling  materials  could 
prove  efficient  in  incentivising  consumers  towards 
opting  for  the  latter,  it  would  require  fundamental 
changes in terms of competence-sharing between the 
EU  and  the  Member  States  in  the  field  of  public 
health, which are highly unlikely.   
The  crematoria  sector  is  not  very  organised  at  EU 
level  as  it  is  not  a  competitive  sector.  Experience 
from voluntary agreements shows that such measures 
result 
low  effectiveness  and  require  heavy 
instruments  to  manage.  Moreover,  the  approach 
would  open  legal  loopholes  and  advantages  for 
market  participants  that  do  not  participate  in  the 
agreements. 
This measure was considered to overlap with CRE#2 
and  the  requirement  for  application  of  BAT  so  was 
discarded on this basis.  

in 

A  burden  sharing  agreement  was  considered  to  be 
most applicable at a national level e.g. as it has been 
applied  in  the  UK.  This  was  not  considered  to  be  a 
feasible option for development or implementation at 
an EU level. 

This  measure  would  go  beyond  the  focus  of  the 
problems  identified  for  the  revision  of  the  Mercury 
Regulation  i.e.  it  could  capture  emissions  from  all 
sectors  and  not  just  crematoria.  This  was  not 
considered  feasible  to  develop  or  the  most  effective 
instrument  for  tackling  emissions  specifically  from 
crematoria.  

PIC  sets  a  prior  informed  consent  procedure  for  the 
export  of  hazardous 
substances  and  articles 
containing  such  substances,  which  does  not  amount 
to an outright prohibition. PIC sets export bans in its 
Annex  V  only  once  such  bans  are  already  set  out  in 
other  EU 
the  Mercury 
Regulation. Such amendments to Annex V to PIC are 
developed  for  consistency  purpose  across  applicable 
Union legislation. 

instruments,  such  as 

1.  Decrease  the  price  difference  between  dental 
amalgam and mercury-free alternatives 

2. Issue EU guidance on mercury emission abatement 
technology  for  controlling  mercury  emissions  from 
crematoria,  alongside  voluntary  agreement  from  the 
sector. 

3. Mercury benchmarks / reduction targets 

4. Burden sharing agreements 

5. National mercury reduction targets 

3. Introduce a PIC procedure to enable third countries 
to  decline  the  import  of  dental  amalgam  capsules 
from the EU 

220 

 
 
 
 
 
 
ANNEX 8: EU and International law on Mercury in respect of 
dental amalgam and mercury-added products  

Current  EU  law  addresses  the  use  of  metallic  mercury  (hereinafter  "mercury")  and 
mercury  compounds  (hereinafter  "mercury  compounds")  in  a  comprehensive  manner. 
The key Union legal instrument is Regulation (EU) No 2017/852 on Mercury (hereinafter 
‘Mercury  Regulation’1  which  covers  the  whole  life  cycle  of  mercury  from  primary 
mercury mining to the final disposal of mercury as waste and transposes the Minamata 
Convention on Mercury (hereinafter ‘Minamata Convention’) into EU law. 

Mercury is classified under EU chemical legislation as a hazardous substance with the 
following  characteristics:  Reproductive  toxicity  (Cat.  1B),  Acute  toxicity  (Acute 
Tox. 2), Specific target organ toxicity – repeated exposure (STOT RE1), Hazardous 
to  the  aquatic  environment  (Aquatic  Acute  1  and  Aquatic  Chronic  1).  Mercury 
compounds  are  also  classified  as  hazardous  substances2.  Additionally,  mercury  is 
listed as a priority hazardous substance under EU water law3.  

Considering  the  level  of  hazardousness  of  mercury  to  both  human  health  and  the 
environment,  this  substance  is  not  only  addressed  in  the  Mercury  Regulation,  but 
also in provisions established in other EU instruments setting specific controls  on inter 
alia  mercury  air  and  water  emissions4,  including  from  industrial  installations5,  the 
temporary storage of mercury waste6 and the mercury content in seafood7,8.          

For the purpose of this document and in view of the scope of application of this initiative, 
this  Annex  focuses  on  existing  EU  provisions  on  dental  amalgam  and  mercury-
containing  lamps  as  set  in  the  Mercury  Regulation,  Directive  2011/65/EU  on  the 
restriction  of  the  use  of  certain  hazardous  substances  in  electrical  and  electronic 

1   Regulation (EU) 2017/852 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). 
2   Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008). 
3   Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a 

framework for Community action in the field of water policy (OJ L 327, 22.12.2000). 

4   Directive  2008/105/EC  of  the  European  Parliament  and  of  the  Council  of  16 December  2008  on 
environmental  quality  standards  in  the  field  of  water  policy,  amending  and  subsequently  repealing 
Council  Directives  82/176/EEC,  83/513/EEC,  84/156/EEC,  84/491/EEC,  86/280/EEC  and  amending 
Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84–97). 
5   Directive  2010/75/EU  of  the  European  Parliament  and  of  the  Council  of  24 November  2010  on 

industrial emissions (OJ L 334, 17.12.2010, p. 17–119). 

6   Council Directive 1999/31/EC of 26 April 1999 on the  landfill of  waste (OJ L 182, 16.7.1999, p. 1–

19).  

7   Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain 

contaminants in foodstuffs (OJ L 364 20.12.2006, p. 5). 

8   Further  information  on  the  EU  acquis  on  mercury  can  be  found  in  Annex  6  to  Commission  Staff 
Working  Document  Impact  Assessment  Ratification  and  Implementation  by  the  EU  of  the  Minamata 
Convention  on  Mercury  -  Accompanying  the  document  Proposal  for  a  Regulation  of  the  European 
Parliament and of the Council on mercury, and repealing Regulation (EC) No 1102/2008, SWD(2016) 
17 final, 2.2.2016.  

221 

 
 
 
                                                           
equipment  (hereinafter  ‘RoHS  Directive’)9  and  the  Minamata  Convention.  This  Annex 
addresses also the Report of the Commission established under Art. 19(1) of the Mercury 
Regulation (hereinafter ‘Commission Review Report’), as its conclusions are part of the 
basis  upon  which  this  document  is  developed10.  At  last,  this  Annex  touches  also  upon 
Decision  MC-4/3  adopted  at  the  fourth  Conference  of  the  Parties  to  the  Convention 
(March  2022)11  since  this  will  also  trigger  amendments  to  Annex  II  (Part  A)  to  the 
Mercury Regulation.  

I.  EU ACQUIS AND INTERNATIONAL LAW ON DENTAL AMALGAM USE  

The  use  of  dental  amalgam  in  the  EU  is  primarily  regulated  under  Art.  10  of  the 
Mercury  Regulation.  Firstly,  this  provision  defines  a  set  of  measures  aiming  at 
promoting  and  hastening  the  phase  down  of  amalgam  use  and  at  reducing  amalgam-
related mercury emissions. They include the prohibition to use mercury in bulk form by 
dental practitioners, the obligation for Member States to develop a national phase down 
plan  and  for  dental  practices  to  be  equipped  with  amalgam  separtors  to  collect  dental 
amalgam waste. Secondly, Art. 10 sets a partial phase-out on the use of dental amalgam 
since  it  prohibits  it  since  1  January  2018  for  treatment  of  deciduous  teeth  and  for 
vulnerable  population  groups  (children  below  the  age  of  15,  pregnant  or  breastfeeding 
women).  

The  use  of  dental  amalgam  is  also  subject  to  specific  provisions  under  the  Minamata 
Convention. Like the Mercury Regulation, the Minamata Convention sets rules on both 
the phase-down and phase-out of the use of dental amalgam. Regarding  phasing-down, 
Art. 4(3) and Annex II to that Convention requires Parties to take at least two measures, 
including,  for  instance,  the  establishment  of  national  objectives  to  minimise  the  use  of 
dental amalgam, the promotion of research and development on mercury-free alternatives 
and  of  environmental  best  practices  within  dental  facilities.  Concerning  phasing-out, 
Parties agreed at the fourth Conference of the Parties to the Convention (March 2022) to 
prohibit  dental  amalagm  use  for  the  same  vulnerable  population  groups  as  under  the 
Mercury Regulation. This prohibition shall enter into force on 28 September 2023.  

As requested under Article 19(1)(b) of the Mercury Regulation, the Commission reported 
on  the  feasibility  of  a  total  phase-out  preferably  by  2030,  taking  into  account  above-
mentioned  national  phase  down  plans  and  whilst  fully  respecting  Member  States' 
competence for the organisation and delivery of health services and medical care. Whilst 
it  concludes  that  such  a  phase-out  is  economically  and  technically  feasible,  the 
Commission Review Report highlights that additional information and assessment (e.g., 
further data on associated mercury emissions) are still necessary to enable the Union to 
make  a  well-founded  legislative  proposal  to  address  the  remaining  use  of  dental 

9   Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction 
of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011).  
10   Report from the Commission to the European Parliament and the Council on the reviews required under 
Article  19  (1)  of  Regulation  2017/852  on  the  use  of  mercury  in  dental  amalgam  and  products, 
COM/2020/378 final. 

11   Decision  MC-4/3:  Review  and  amendment  of  annexes  A  and  B  to  the  Minamata  Convention  on 

Mercury, UNEP/MC/COP.4/Dec.3.  

222 

 
 
 
 
 
       
                                                           
amalgam. Such complementary information and assessment are contained in the relevant 
sections of this Staff Working Document.  

II.  EU  ACQUIS  AND  INTERNATIONAL  LAW  ON  MERCURY-ADDED 

PRODUCTS (MAPS) 

1.  THE PLACING ON THE EU MARKET AND IMPORT INTO THE EU OF MAPS 

The placing on the market and import of MAPs is regulated at Union level by means of 
several  legal  instruments,  including  e.g.  Regulation  (EC)  1907/2006  REACH12, 
Regulation  (EC)  1223/2009  on  cosmetic  products13  and    Directive  (EC)  2006/66  on 
Batteries  Directive14.  The  concerned  products  are  prohibited  from  being  placed  on  the 
market  and  imported  when  their  mercury  content  exceeds  a  certain  limit  ranging  from 
zero (e.g. thermometers, barometers) to  a specific maximum  limit  (e.g.  0,007 % in  eye 
products)15.  In  this  regard  and  as  stated  earlier,  this  Annex  addresses  in  particular  the 
RoHS Directive that regulates the mercury content in lamps.   

Whereas  neither  the  Mercury  Regulation  nor  the  Minamata  Convention  addresses  the 
placing  on  the  (EU  or  international)  market  of  MAPs,  both  instruments  address  their 
manufacturing, import and export.     

2.  THE MANUFACTURING, IMPORT AND EXPORT OF MAPS 

2.1  The Mercury Regulation  

Art. 5 of the Mercury Regulation provides that the manufacturing and international trade 
of  the  MAPs  listed  in  its  Annex  II  (Part  A)  are  prohibited  as  from  the  dates  specified 
therein  (1  January  2019  or  1  January  2021).  Currently,  Annex  II  contains  nine  entries 
covering  certain  MAP,  including  (i)  batteries  or  accumulators,  (ii)  switches  and  relays, 
(iii) cosmetic products, (iv) pesticides, biocides and topical antiseptics, (v) a set of non-
electronic  measuring  devices,  (vi)  specific  compact  fluorescent  lamps  (CFLs),  (vii) 
specific linear fluorescent  lamps (LFLs) and (viii) high  pressure mercury vapour lamps 
and  (ix)  certain  cold  cathode  fluorescent  lamps  (CCFLs)  and  external  electrode 
fluorescent lamps (EEFLs).  

12   Regulation (EC) No 1907/2006 of the European Parliament and of the  Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 
76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 
30.12.2006). 
13   Regulation (EC) No 1223/2009 of the European Parliament and of the Council  of 30 November 2009 
on cosmetic products (OJ L 342 22.12.2009, p. 59). 
14   Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries 
and  accumulators  and  waste  batteries  and  accumulators  and  repealing  Directive  91/157/EEC  (OJ  L  266 
26.9.2006, p. 1). 
15   For more information on identified existing mercury-added products and associated EU legislation, see 
the  inventory  developed  by  the  Commission  in  accordance  with  Art.  8(7)  of  the  Mercury  Regulation, 
available  at:  https://circabc.europa.eu/ui/group/19e66753-84ca-4e4e-a4a1-73befb368fc2/library/d198684c-
0834-4f20-9682-dc66553ed066/details  

223 

 
 
 
 
 
 
 
 
 
                                                           
Hence, the Mercury Regulation complements above-mentioned EU legal instruments that 
prohibits the placing on the market and import of those MAPs.  

2.2  The Minamata Convention and Decision MC-4/3 

Similarly, Art. 4(1) and Annex A (Part I) to the Minamata Convention prohibits since 1 
January  2021  the  manufacture,  import  and  exports  of  the  MAPs,  which  are  listed  in 
Annex  II  (Part  A)  to  the  Mercury  Regulation.  This  similarity  in  scope  stems  from  the 
instrumental role played by the EU in the course of the negotiations on the establishment 
of the Minamata Convention.  

The scope of application of the Minamata Convention regarding MAPs has recently been 
extended by means of paragraph 1 of Decision MC-4/3 adopted by Parties at the fourth 
meeting  of  the  Conference  of  the  Parties  to  the  Convention  (COP4,  March  2022).  In 
particular,  Parties  agreed  to  prohibit  the  manufacturing,  import  and  export  of  eight 
additional MAPs as from 1 January 2026, including: 

(i) 

(ii) 

CFL.i16 for  general  lighting purposes that are ≤ 30  watts  with  mercury  content 
not exceeding 2,5 mg per lamp burner,  
CCFLs and EEFL of all lengths for electronic displays, that are not yet included 
in Annex II (Part A),  

(iii)  Melt pressure transducers, transmitters and pressure sensors,  
(iv) 
(v) 
(vi) 
(vii) 
(viii) 

Mercury vacuum pumps,  
Tire balancers and wheel weights,  
Photographic film and paper, 
Propellant for satellites and spacecraft,  
Strain gauges to be used in plethysmographs17 

The adding of those MAPs  to  Annex A (Part I) to the Minamata Convention  was fully 
supported by the EU18, 19. In such case, Article 20 of the Mercury Regulation provides that 
the Commission is empowered to adopt delegated acts in order to amend e.g., Annex II 
(Part  A)  to  that  Regulation  to  align  it  with  decisions  adopted  by  the  Parties  to  the 
Minamata  Convention.  Hence,  a  Commission  Delegated  Regulation  transposing 
paragraph 1 of Decision MC-4/3 is developed alongside this initiative.   

16   ‘CFL.i’ means compact fluorescent lamps with integrated ballast.   
17  Those  MAPs  are  already  prohibited  from  being  manufactured,  imported  and  exported  from  the  EU  in 
accordance with Annex II (Part A)(entry 9(f) to the Mercury Regulation.   
18   Council Decision (EU) 2021/727 of 29 April 2021 on the submission, on behalf of the European Union, 
of  proposals  to  amend  Annexes  A  and  B  to  the  Minamata  Convention  on  Mercury,  regarding  mercury-
added products and manufacturing processes in which mercury or mercury compounds are used (OJ L 55 
of 5.5.2021, p. 23). 
19   Council  Decision  (EU) 2022/549  of  17 March  2022  on  the  position  to  be  taken  on  behalf  of  the 
European Union  at  the  second  segment  of  the  fourth  meeting  of  the  Conference  of  the  Parties  to  the 
Minamata Convention on Mercury as regards the adoption of a Decision to amend Annexes A and B to that 
Convention (OJ L 107, 6.4.2022, p. 78). 

224 

 
 
 
 
 
 
 
 
 
                                                           
Furthemore, in accordance with paragraph 5 of Decision MC-4/3, Parties agreed also to 
consider  at  COP5  (November  2023)  a  possible  supplementary  extension  of  the  list  of 
MAPs contained in Annex A (Part I) to the Convention and possible associated phase-out 
dates. Concerned MAPs and phase-out dates include as follows:  

(i) 

(ii) 

Button zinc silver oxide batteries with a mercury content < 2% and button zinc 
air  batteries  with  a  mercury  content  <  2%,  to  be  prohibited  from  being 
manufactured and traded as from 2026 or 2030. 

Very  high  accuracy  capacitance  and  loss  measurement  bridges  and  high 
frequency  radio  frequency  switches  and  relays  in  monitoring  and  control 
instruments  with  a  maximum  mercury  content  of  20  mg  per  bridge  switch  or 
relay  [except  those  used  for  research  and  development  purposes],  to  be 
prohibited from being manufactured and traded as from 2026., 

(iii) 

Linear fluorescent lamps (LFLs) for general lighting purposes, to be prohibited 
from being manufactured and traded as from 2026, 2028 or 2031: 

(a)  Halophosphate phosphor ≤ 40 watts with a mercury content not exceeding 

10 mg per lamp 

(b)  Halophosphate phosphor > 40 watts  

(iv) 

  Linear fluorescent lamps (LFLs) for general lighting purposes: 

(a)  Triband  phosphor  <  60  watts  with  a  mercury  content  not  exceeding  5 
mg/lamp,  to  be  prohibited  from  being  manufactured  and  traded  as  from 
2028 or 2031. 

Whereas those lamps are not listed amongst MAPs contained in Annex II (Part A) to the 
Mercury  Regulation,  they  are subject  to  a prohibition  from  being placed  on the market 
and  imported  in  accordance  with  RoHS,  and  therefore  fall  within  the  scope  of  this 
initiative  amongst  others  (HPS).  In  this  context,  the  Commission  Review  Report 
identifies two possible approaches.  

-  The  first  approach  would  make  the  concerned  MAPs  subject  to  an  EU  ban  on 
manufacturing  and  international  trade  by  adding  them  to  Annex  II  (Part  A)  to  the 
Mercury Regulation. The environmental impacts of such an ‘EU ban’ could be either 
positive  or  negative  depending  on  the  extent  to  which  EU  production  would  be 
substituted by production in third countries.  

-  The  second  approach  would  focus  on  the  Union’s  effort  to  negotiate  and  agree  at 
global level on an extension of the list of MAPs referred to in Annex A (Part I) to the 
Minamata Convention at COP5 or subsequent COPs. The successful applicability of 
this second option depends primarily on the uncertain level of ambition of the other 
Parties  to  the  Minamata  Convention.  This  is  one  of  the  key  the  reasons  why  the 
preferred option identified in this document in respect of problem area 2 consists, as 
a first step, of amending Annex II (Part A) to the Mercury Regulation to align it with 
provisions  set  out  under  RoHS  prohibiting  the  placing  on  the  market  of  several 

225 

 
 
 
 
 
 
 
 
 
 
 
mercury-containing  lamps,  and,  as  a  second  step,  of  pushing  for  an  agreement  at 
Minamata level  to  extend again  the scope of application of  Art.  4(1) and Annex A 
(Part I) to the Convention to align it with the then amended Annex II (Part A) to the 
Mercury Regulation.    

3.  TO  ALIGN  ANNEX  II  (PART  A)  TO  THE  MERCURY  REGULATION  WITH  RELEVANT 

ROHS RESTRICTIONS ON MERCURY-CONTAINING LAMPS.  

Without  prejudice  to  the  legal  obligation  to  complement  Annex  II  (Part  A)  to  the 
Mercury  Regulation  with  the  seven  MAPs  covered  by  above-mentioned  Decision  MC-
4/3 (paragraph 1), this initiative aims also, for the purpose of implementing Art. 19(1)(c) 
and  (3)  of  the  Mercury  Regulation,  at  aligning  Annex  II  (Part  A)  to  the  Mercury 
Regulation with the relevant restrictions set out under RoHS. The objective is to ensure 
below listed MAPs, which are already prohibited from  being placed on  the market  and 
imported  in  the  EU  in  accordance  with  RoHS,  are  also  made  subject  to  a  ban  on 
manufacturing  and  export  by  adding  them  to  Annex  II  (Part  A)  to  the  Mercury 
Regulation. As explained in this Staff Working Document, this initiative focuses on the 
three types of mercury-containing lamps for general lighting purposes accounting for the 
most important intentional mercury uses in products alongside dental amalgam.     

3.1  The case of mercury-containing compact fluorescent lamps (CFLs) for general 

lighting purposes 

On the one hand, current Annex II (Part A) (entry 3) to the Mercury Regulation prohibits 
the manufacturing, import and export of the following CFLs:   

(a) 

(b) 

CFL.i  ≤  30  watts  with  mercury  content  >  2,5  mg  per  lamp  burner  for  general 
lighting purposes 
CFL.ni20 ≤ 30 watts with mercury content > 3,5 mg per lamp burner for general 
lighting purposes  

On  the  other  hand,  as  a  follow-up  to  the  adoption  of  Commission  Delegated  Directive 
(EU)  2022/27621  amending Annex  III  (entries  1,  1(a),  1(b),  1(c),  1(d)  and 1(e)  to  the 
RoHS Directive), as from 24 February 2023, all CFLs for general lighting purposes can 
only  be  placed  on  the  Union  market  and  imported  into  the  EU  if  they  contain  zero 
mercury content.    

Hence, should the co-legislators agree on an alignment between the Mercury Regulation 
and RoHS regarding those lamps, it would imply that above-mentioned existing entry 3 
of Annex II (Part A) to this Regulation would need to be amended in such a way as to 
provide  that  all  CFLs  (including  all  CFL.i  and  CFL.ni.)  for  general  lighting  purposes 

20 ‘ CFL ni’ means compact fluorescent lamps without integrated ballast.   
21   Commission  Delegated  Directive  (EU)  2022/276 of  13 December  2021  amending,  for  the  purpose  of 
adapting  to  technical  and  scientific  progress,  Annex  III  to  Directive  2011/65/EU  of  the  European 
Parliament and of the Council as regards an exemption for the use of mercury in single capped (compact) 
fluorescent lamps for general lighting purposes (OJ L 43, 24.2.2022, p. 32–34).  

226 

 
 
 
 
 
 
 
   
 
                                                           
containing  mercury  would  be  prohibited  from  being  manufactured  in  the  EU,  imported 
into the EU and exported from the EU.  

3.2  The case of mercury-containing linear fluorescent lamps (LFLs) for general lighting 

purposes - Triband phosphor LFLs  

On  the  one  hand,  current  Annex  II  (Part  A)  (entry  4)(a)  to  the  Mercury  Regulation 
prohibits the manufacturing, import and export of the following triband phosphor LFLs:   

(a)  Triband phosphor < 60  W with  Hg content > 5  mg per lamp burner for  general 

lighting purposes    

On  the  other  hand,  as  a  follow-up  to  the  adoption  of  Commission  Delegated  Directive 
(EU)  2022/28422  amending Annex  III  (entries  2(a),  2(a)(1),  2(a)(2),  2(a)(3),  2(a)(4) 
and 2(a)(5))  to  the  RoHS  Directive,  as  from  24  February  2023  or  24  August  2023,  all 
triband  phosphor  LFLs    for  general  lighting  purposes  can  only  be  placed  on  the  Union 
market and imported into the EU if they contain zero mercury content.  

Hence, should the co-legislators agree on an alignment between the Mercury Regulation 
and  RoHS  regarding  those  lamps,  it  would  imply  that  above-mentioned  existing  entry 
4(a) of Annex II (Part A) to this Regulation would need to be amended in such a way as 
to  provide  that  all  triband  phosphor  LFLs  for  general  lighting  purposes  containing 
mercury will be prohibited from being manufactured in the EU, imported into the EU and 
exported from the EU. In doing so, this takes full account of the phase-out dates for those 
lamps for consideration at COP5 or at subsequent COPs (uncertain outcome), contained 
in above-mentioned paragraph 5 of Decision MC-4/3.  

3.3  The case of mercury-containing halophosphate fluorescent lamps for general lighting 

purposes 

On  the  one  hand,  current  Annex  II  (Part  A)  (entry  4)(b)  to  the  Mercury  Regulation 
prohibits  the  manufacturing,  import  and  export  of  the  following  halophosphate 
fluorescent LFLs:   

(b) Halophosphate  phosphor  (LFLs)  <  40  watts  with  mercury  content  >  10  mg  per 

lamp burner for general lighting purposes    

On  the  other  hand,  Annex  III  (entries  2(b)(1)  and  2(b)(2))  to  the  RoHS  Directive 
prohibits, since 13 April 2012 and 13 April 2016, the placing on the market and import of 
(i) linear halophosphate phosphor lamps with tube diameter > 28 mm (e.g. T10 and T12) 
and (ii) all non-linear halophosphate phosphor lamps.  

22   Commission Delegated Directive (EU) 2022/284 of 16 December 2021 amending, for the purposes of 
adapting  to  scientific  and  technical  progress,  Annex  III  to  Directive  2011/65/EU  of  the  European 
Parliament  and  of  the  Council  as  regards  an  exemption  for  the  use  of  mercury  in  double-capped  linear 
fluorescent lamps for general lighting purposes (OJ L 43, 24.2.2022, p. 57–59). 

227 

 
 
 
 
 
   
 
 
 
 
   
 
                                                           
Hence, should the co-legislators agree on an alignment between the Mercury Regulation 
and  RoHS  regarding  those  lamps  with  a  view  to  aligning  Annex  II  (Part  A)  to  the 
Mercury Regulation with the RoHS Directive as far as halophosphate phosphor lamps are 
concerned, above-mentioned existing entry 4(b) of that Annex will need to be amended 
in  such  a  way  as  to  provide  that  all  halophosphate  phosphor  lamps  will  be  prohibited 
from being manufactured in the EU, imported into the EU and exported from the EU. In 
doing so, this takes full account of the phase-out dates for those lamps for consideration 
at  COP5  or  at  subsequent  COPs  (uncertain  outcome),  contained  in  above-mentioned 
paragraph 5 of Decision MC-4/3. 

3.4  The case of high-pressure sodium lamps for general lighting purposes 

As  a  follow-up  to  the  adoption  of  Commission  Delegated  Directive  (EU)  2022/28323 
amending Annex  III  (entries  4(b)(I),  4(b)(II)  and  4(b)(III))  to  the  RoHS  Directive,  as 
from 24 February 2023, high pressure sodium (vapour) lamps  (HPS) for general lighting 
purposes with improved colour rendering index Ra > 60: P ≤ 155 W, > 60: 155 W < P ≤ 
405 W or > 60: P > 405 W can only be placed on the Union market and imported into the 
EU if they contain zero mercury content.  

Hence, should the co-legislators agree on an alignment between the Mercury Regulation 
and  RoHS  regarding  those  lamps  with  a  view  to  aligning  Annex  II  (Part  A)  to  the 
Mercury  Regulation  with  the  RoHS  Directive  as  far  as  above-cited  HPS  lamps  are 
concerned,  that  Annex  will  need  to  be  amended  in  such  a  way  as  to  provide  that 
concerned HPS lamps will be prohibited from being manufactured in the EU, imported 
into the EU and exported from the EU. 

4.  THE  SPECIFIC  CASE  OF  THE  MANUFACTURING,  IMPORT  AND  EXPORT  OF  DENTAL 

AMALGAM  

Under current EU and international law, there are no restrictions on the manufacturing, 
import and export of dental amalgam. Should  the co-legislator agree on  prohibiting the 
manufacture and export of dental amalgam whilst allowing the import for EU use only to 
cover  specific  medical  needs  of  patients,  the  Mercury  Regulation  would  need  to  be 
amended accordingly (either by means of an amendment to its Art. 10).         

23   Commission Delegated Directive (EU) 2022/283 of 13 December 2021 amending, for the purposes of 
adapting  to  scientific  and  technical  progress,  Annex  III  to  Directive  2011/65/EU  of  the  European 
Parliament  and  of  the  Council  as  regards  an  exemption  for  the  use  of  mercury  in  High  Pressure  Sodium 
(vapour) lamps with improved colour rendering index for general lighting purposes (OJ L 43, 24.2.2022, p. 
54–56). 

228