COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/37/EC as regards the addition of substances and setting limit values in its Annexes I, III and IIIa
Date: 2025-07-18
Institutions: Directorate-General for Employment, Social Affairs and Inclusion, European Commission
Subjects: carcinogenic substance, health risk, occupational disease, occupational health, safety standard, toxic substance

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 18.7.2025  SWD(2025) 192 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT REPORT  Accompanying the document Proposal for a Directive of the European Parliament and of the Council   amending Directive 2004/37/EC as regards the addition of substances and setting limit values in its Annexes I, III and IIIa {COM(2025) 418 final} - {SEC(2025) 217 final} - {SWD(2025) 191 final} - {SWD(2025) 193 final}  
 
 
Table of contents 

1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ............................................................... 1 

1.1.  Political context ................................................................................................. 1 
1.2.  Legal context ..................................................................................................... 4 
1.3.  Evidence-based procedure supporting the continuous revision of the CMRD . 4 

2. 

PROBLEM DEFINITION .................................................................................................................... 6 

2.1.  What is/are the problems? ................................................................................. 6 
2.2.  What are the problem drivers? .......................................................................... 9 
2.3.  How likely is the problem to persist? .............................................................. 14 

3.  WHY SHOULD THE EU ACT? ........................................................................................................ 15 

3.1.  Legal basis ....................................................................................................... 15 
3.2.  Subsidiarity: Necessity of EU action ............................................................... 15 
3.3.  Subsidiarity: Added value of EU action .......................................................... 16 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................... 17 

4.1.  General objectives ........................................................................................... 17 
4.2.  Specific objectives ........................................................................................... 18 
4.3.  Consistency with other EU policies ................................................................ 18 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? .................................................................... 20 

5.1.  What is the baseline from which options are assessed? .................................. 20 
5.2.  Description of the policy options .................................................................... 26 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ........................................................... 32 

6.1.  Cobalt and inorganic cobalt compounds ......................................................... 34 
6.2.  PAHs ................................................................................................................ 44 
6.3.  1,4-dioxane ...................................................................................................... 53 
6.4.  Welding fumes ................................................................................................. 58 

7.  HOW DO THE OPTIONS COMPARE? ............................................................................................ 61 

7.1.  Cobalt and its inorganic compounds ............................................................... 62 
7.2.  PAHs ................................................................................................................ 64 
7.3.  1,4-dioxane ...................................................................................................... 67 
7.4.  Welding fumes ................................................................................................. 68 

8. 

PREFERRED OPTION ...................................................................................................................... 69 

8.1.  Selection of the preferred policy options and analysis of impacts .................. 69 
8.2.  Subsidiarity and proportionality ...................................................................... 75 
8.3.  REFIT (simplification and improved efficiency) ............................................ 77 
8.4.  Application of the ‘one in, one out’ approach ................................................. 77 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 77 

9.1.  Monitoring arrangements ................................................................................ 77 

 
 
 
9.2.  Evaluation arrangements ................................................................................. 80 

ANNEX 1: PROCEDURAL INFORMATION ............................................................................................ 81 

ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) ................................................ 99 

ANNEX 3: WHO IS AFFECTED AND HOW? ........................................................................................ 118 

ANNEX 4: ANALYTICAL METHODS AND MULTI-CRITERIA ANALYSIS .................................... 122 

ANNEX 5: COMPETITIVENESS CHECK .............................................................................................. 182 

ANNEX  6:  RELEVANT  SECTORS,  USES,  EXPOSURE  CONCENTRATIONS  AND  NATIONAL 

REGULATORY FRAMEWORKS ................................................................................................... 185 

ANNEX 7: ROUTE(S) OF EXPOSURE AND ADVERSE HEALTH EFFECTS .................................... 272 

ANNEX  8:  PROCESS  FOR  SETTING  BINDING  LIMIT  VALUES  AND  ASSOCIATED  PROVISIONS 

UNDER THE CMRD ....................................................................................................................... 277 

ANNEX 9: DATA SUPPORTING THE SETTING OF POLICY OPTIONS ........................................... 281 

ANNEX 10: ACCOMPANYING MEASURES AND OPTIONS DISCARDED...................................... 284 

ANNEX 11: CONSISTENCY AND COMPLEMENTARITY WITH THE REACH REGULATION ..... 294 

ANNEX 12: SME TEST ............................................................................................................................ 300 

 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

ACSH 
AM 
BLV 
BaP 
C/B 
CAD 
CAS 
CDB 
CLP 
CSRs 
CVD 
CMRD 

DALYs 
DG 
DRR 
ECHA 
EPRS 
ERR 
ETUC 
EU 
FDB 
GM 
HMPs 
IARC 
ISG 
OEL(s) 
OSH 
PAHs 
PGS 
PO 
PPM 
PV 
R&D 
RAC 
REACH 

REFIT 
RMMs 
RPA 
RPE 
RSB 
SDGs 
SLA 

Advisory Committee on Safety and Health at work 
Arithmetic mean 
Biological limit value 
Benzo[a]pyrene 
Costs/benefits 
Chemical Agents Directive 98/24/EC 
Chemical Abstracts Service 
Current disease burden 
Classification, labelling and Packaging  
Chemical Safety Reports  
Cardiovascular diseases 
Carcinogens,  Mutagens  and  Reprotoxic  substances 
Directive 2004/37/EC 
Disability-adjusted life years 
Directorate-General  
Dose-response relationship 
European Chemicals Agency 
European Pillar of Social Rights 
Exposure-risk relationship 
European Trade Union Confederation 
European Union 
Future disease burden 
Geometric mean 
Hazardous medicinal products 
International Agency for Research on Cancer 
Inter-service Steering Group 
Occupational exposure limit(s) 
Occupational safety and health  
Polycyclic aromatic hydrocarbons 
Process-generated substance 
Policy option 
Parts per million 
Present value 
Research and development 
Risk Assessment Committee 
Registration, Evaluation,  Authorisation  and Restriction 
of Chemicals 
Regulatory fitness and performance programme 
Risk Management Measures  
Risk & Policy Analysts Ltd 
Respiratory protective equipment 
Regulatory Scrutiny Board 
Sustainable Development Goals 
Service-level agreement 

 
 
 
SLIC 
SMEs 
STEL 
SVHC 
SWD 
TFEU 
TWA 
WPC 
WTP 

Senior Labour Inspectors’ Committee 
Small and medium-sized enterprises 
Short-term limit value 
Substance of very high concern  
Staff Working Document 
Treaty on the Functioning of the European Union  
Time-weighted average 
Working Party on Chemicals  
Willingness to pay 

 
 
 
 
1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

1.1. 

Political context 

In June 2021, the Commission presented the EU strategic framework on health and safety at work 
2021-20271 (‘EU OSH strategic framework’). This strategic framework aims to turn into concrete 
actions principle 10 enshrined in the European Pillar of Social Rights2 (‘EPSR’) related to workers’ 
right  to  a  high  level  of  protection  of  their  health  and  safety  at  work.  In  particular,  it  strengthens 
prevention  culture,  both  in  organisations  and  among  individual  workers  to  reduce  work-related 
deaths as much as possible, in line with a Vision Zero approach to work-related deaths in the EU.  

One  of  the  objectives  of  the  strategic  framework  is  the  prevention  of  workplace  accidents  and 
illnesses, which can cause serious adverse health effects on workers, including fatalities, and which 
lead to an estimated annual loss of around 3.3% of gross domestic product in the EU.  

As shown in figure 1, cancer remains the first cause of work-related death in the EU, followed by 
cardiovascular diseases (CVD). Every year, according to estimates, about 80,000 people in the EU 
lose their lives due to exposure to carcinogens at the place of work.  

Figure 1: work-related deaths in the EU, ICOH 20193 

Exposure  to  reprotoxic  substances  at  the  place  of  work  can  also  lead  to  serious  adverse  health 
effects,  by  affecting  sexual  function  and  fertility.  It  might  also  cause  adverse  effects  on  the 
development of workers’ offspring. Up to 1,274 reproductive ill-health cases in the EU could occur 

1  Communication  from  the  Commission  on  EU  strategic  framework  on  health  and  safety  at  work  2021-2027 
Occupational safety and health in a changing world of work, COM/2021/323 final 
2 Communication from the Commission on establishing a European Pillar of Social Rights, COM/2017/0250 final 
3  EU-OSHA  (2023),  Occupational  safety  and  health  in  Europe:  state  and  trends  2023  –  Summary,  based  on 
International Commission on Occupational Health’s figures 

1 

 
 
 
 
every  year  following  exposure  to  reprotoxic  substances  that  are  not  classified  as  carcinogenic  or 
mutagenic4. 

To  improve  the  prevention  of  work-related  diseases  in  the  EU,  the  Commission  is  pursuing  a 
continuous update of the Carcinogens, Mutagens and Reprotoxic substances Directive 2004/37/EC5 
(‘CMRD’). This revision process is in line with the obligation laid down in the CMRD to  set out 
limit values for all those carcinogens, mutagens or reprotoxic substances for which this is possible. 
It also responds to requests made notably by:  

•  stakeholders  for  considering  the  need  to  adopt  limit  values  for  more  substances,  as 
highlighted in the REFIT occupational safety and health (‘OSH’) evaluation6 (‘REFIT OSH 
evaluation’); and  
the  European  Parliament  and  the  Council  as  part  of  the  fourth  revision  of  the  CMRD7 
(‘CMRD 4’) to achieve new or revised occupational exposure limit values (‘OELs’) for at 
least 25 substances; and 

• 

•  14 Member States8 in  a letter dated 6 March 2024 and sent  to  the Commission  to  request 

limit values for more substances in the future.  

Since the initiation of this continuous process in 2016, the EU has already adopted five revisions of 
the CMRD, addressing more than 40 key hazardous chemicals and contributing to saving the life of 
more than 100,000 workers over the next 50 years. The fifth legislative proposal for a revision of 
the CMRD9, addressing lead, a key reprotoxic substance, was formally adopted in February 2024 
and entered into force on 8 April 2024. The initiative subject to this impact assessment is therefore 
the sixth revision of the CMRD. It aims to further improve workers’ protection and save lives in the 
future.  

This  continuous revision process  relies on an inclusive  approach  where the Commission  involves 
scientists from the European Chemicals Agency’s (‘ECHA’) Risk Assessment Committee (‘RAC’), 
Member States and social partners represented in the Advisory Committee on Safety and Health at 
Work (‘ACSH’), and the social partners through the formal consultation provided by Article 154 of 
the Treaty on the Functioning of the European Union (‘TFEU’). The ACSH is composed of three 
full  members  (and  six  alternates)  per  Member  States,  representing  national  governments,  trade 
unions  and  employers’  organisations.  Its  composition  reflects  the  various  economic  sectors 
concerned  (e.g.  construction, industry,  etc.) and the different  sizes of companies  (incl.  SMEs), so 
that  its  opinions  are  based  on  the  realities  on  the  ground  of  the  different  sectors  and  companies. 

4 European Commission, Directorate-General for Employment, Social Affairs and Inclusion, Cary, E., Holmes, P., 
Vencovsky, D. et al., Study to collect recent information relevant to modernising EU Occupational Safety and Health 
chemicals legislation with a particular emphasis on reprotoxic chemicals with the view to analyse the health, socio-
economic and environmental impacts in connection with possible amendments of Directive 2004/37/EC and Directive 
98/24/EC – Final report. Report 1, Baseline assessment, Publications Office, 2019, 
https://data.europa.eu/doi/10.2767/964906  
5 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers 
from the risks related to exposure to carcinogens or mutagens at work, OJ L 158, 30.4.2004, p. 50-76 
6 Ex-post evaluation of the EU occupational safety and health Directives (REFIT evaluation) – SWD (2017) 10 final 
7  Directive  (EU)  2022/431  of  9  March  2022  amending  Directive  2004/37/EC  on  the  protection  of  workers  from  the 
risks related to exposure to carcinogens or mutagens at work, OJ L 88, 16.3.2022, p. 1-14 
8 CY, CZ, DK, ES, FI, FR, DE, IT, LT, LU, NL, PT, SI and SE 
9  Directive  (EU)  2024/869  of  the  European  Parliament  and  of  the  Council  of  13 March  2024  amending 
Directive 2004/37/EC  of  the European  Parliament  and  of  the  Council  and  Council  Directive 98/24/EC  as  regards  the 
limit values for lead and its inorganic compounds and for diisocyanates, OJ L, 2024/869, 19.03.2024.  

2 

 
 
Furthermore, as it also include one full member (and two alternates) from each Member States, its 
opinions also take account of the economic and social specificities of each country.  

As  part  of  the  2nd  stage  consultation  of  social  partners,  BusinessEurope  and  the  European  Trade 
Union  Confederation  (‘ETUC’)  supported  the  ACSH  opinions  while  SMEunited  called  on  the 
Commission  not  to  go  beyond  what  was  agreed  by  the  ACSH.  This  inclusive  process  allows  for 
revisions  of  the  CMRD  which  provide  a  high  level  of  protection  of  workers’  health  while  being 
socio-economically  viable  and  technically  feasible  for  businesses.  More  information  on  the 
evidence-based procedure supporting the continuous revision of the CMRD is available in section 
1.3 and annex 8.  

The planned sixth revision of the CMRD (‘CMRD 6’), subject to this impact assessment, fits into 
this continuous revision process and contributes to the European Health Union. It also delivers on 
the European Parliament’s and the Council’s request through CMRD 4 to set an OEL for cobalt and 
inorganic  cobalt  compounds10,  and  the  substances  identified  for  this  revision  are  based  on  the 
Commission  Staff  Working  Document  (SWD)  listing  the  priority  substances  to  be  scientifically 
assessed11.      

Importantly, hazardous substances are not limited to carcinogens, mutagens and reprotoxins. There 
are other types of substances that fall under EU OSH legislation, in particular the Chemical Agents 
Directive12  (‘CAD’),  that  cause  other  types  of  ill-health  effects  (e.g.  respiratory  ill-health)  and 
should be tackled.   

By  improving  the  prevention  of  work-related  diseases,  the  CMRD  6  will  also  contribute  to  the 
United Nations 2030 Agenda for a Sustainable Development13, in particular its goal 314 (“Ensuring 
healthy  lives  and  promote  well-being  for  all  at  all  ages”)  and  goal  815  (“Promote  sustained, 
inclusive and sustainable economic growth,  full and productive employment  and decent  work for 
all”).  

In  order  to  collect  more  recent  information  to  support  this  impact  assessment,  the  Commission 
contracted an external study16. This study was scrutinised by the relevant Commission services and 
members of the ACSH’s Working Party on Chemicals (WPC).  

10  Article  1  (15)  of  Directive  (EU)  2022/431:  “No  later  than  31  December  2024,  the  Commission  shall,  taking  into 
account  the  latest  developments  in  scientific  knowledge,  and  after  appropriate  consultation  of  relevant  stakeholders, 
propose, where appropriate, a limit value for cobalt and inorganic cobal compounds”  
11 Commission Staff Working Document List of substances to be scientifically assessed for the purposes of Article 18a, 
third  paragraph,  of  Directive  (EU)  2004/37/EC  on  presenting  an  action  plan  to  achieve  new  or  revised  occupational 
exposure  limit  values  for  at  least  25  substances,  groups  of  substances  or  process-generated  substances,  SWD  (2022) 
438 final 
12  Council  Directive  98/24/EC  of  7  April  1998  on  the  protection  of  the  health  and  safety  of  workers  from  the  risks 
related to chemical agents at work, OJ L 131, 5.5.1998, p. 11-23 
13 United Nations resolution entitled ‘Transforming our World: the 2030 Agenda for Sustainable Development, adopted 
at the UN Sustainable Development Summit on 25 September 2015 in New York 
14  In  particular,  target  3.4  (“by  2030,  reducing  by  one  third  premature  mortality  from  non-communicable  diseases 
through  prevention”)  and  target  3.9  (“by  2030,  substantially  reducing  the  number  of  deaths  and  illnesses  from 
hazardous chemicals”) 
15 In particular, target 8.8 (“promoting safe and securing working environments for all workers”) 
16 RPA (2024), Study on collecting the most recent information on substances to analyse health, socio-economic and 
environmental impacts in connection with possible amendments of Directive 2004/37/EC on the protection of workers 
from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work 

3 

 
 
1.2.  Legal context 

The main legislative instrument to ensure workers' protection against risks related to carcinogenic, 
mutagenic or reprotoxic chemicals is the CMRD, an individual directive under the OSH Framework 
Directive17. 

Whether  a  substance  or  mixture  is  under  the  scope  of  the  CMRD  is  primarily  based  on  its 
classification as a carcinogen, mutagen and/or reprotoxic substance (category 1A or 1B) according 
to the criteria established under the CLP (classification, labelling and packaging of substances and 
mixtures) Regulation18. 

There is also a possibility to bring a substance/mixture under the scope of the CMRD by including 
it  in  Annex  I  to  the  CMRD.  This  Annex  covers  substances,  mixtures  or  processes  (or 
substances/mixtures  released  by  a  process  referred  to  in  that  Annex)  which  are  not  classified 
according  to  the  CLP  Regulation  as  carcinogens,  mutagens  or  reprotoxic  substances  but  are  for 
example  recognised  by  other  international  bodies  (e.g.  the  International  Agency  for  Research  on 
Cancer - IARC) as substances, mixtures or processes of equal concern. These substances are often 
referred to as Process-Generated Substances (PGS). Annex I currently contains 8 entries. 

To  reduce  the  occupational  exposure  to  these  substances  or  mixtures,  the  CMRD  provides  for  a 
hierarchy  of  preventive  and  protective  measures.  The  employer  has  the  obligation  to  substitute 
these  chemicals  by  less  or  non-hazardous  substances,  mixtures  or  processes  as  far  as  technically 
possible. If substitution is not technically possible, other measures to prevent exposure have to be 
put  in  place  by  the  employer,  such  as  working  in  a  closed  system  or  reducing  the  number  of 
workers potentially exposed. 

Another  obligation  of  the  employer  is  to  ensure  that  binding  OELs  and  biological  limit  values 
(BLVs) set out in Annex III and Annex IIIb to the CMRD respectively shall not be exceeded. For 
binding  EU  OELs  and  BLVs  adopted  under  the  CMRD,  Member  States  must  establish  a 
corresponding national limit value at least at the EU level or lower value (more protective). 

1.3.  Evidence-based procedure supporting the continuous revision of the CMRD 

Setting new or revised limit values for carcinogens, mutagens or reprotoxic substances, or enlarging 
the  list  of  substances,  mixtures  and  processes  in  Annex  I,  requires  a  revision  of  the  CMRD.  To 
support  this  revision  process,  the  Commission  relies  on  a  sound,  comprehensive  and  evidence-
based procedure, during which the consultation of the relevant stakeholders is key. This procedure 
ensures  that  the  revisions  of  the  CMRD  are  based  on  scientific  evidence,  while  technically  and 
socio-economic feasible for businesses of all sizes.   

The  figure  below  summarises  this  stepwise  procedure  starting  with  the  prioritisation  of  the 
substances  to  be  addressed  and  ending  with  the  publication  of  the  Directive  adopted  by  the 
European  Parliament  and  the  Council,  based  on  the  legal  proposal  by  the  Commission,  in  the 

17 Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the 
safety and health of workers at work, OJ L 183, 29.6.1989, p. 1-8 
18  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,  OJ  L  353,  31.12.2008,  p.  1–1355.  The  CLP 
Regulation  is  the  core  piece  of  legislation  used  in  the  EU  to  identify  and  communicate  the  hazardous  properties  of 
chemicals. 

4 

 
 
Official Journal of the EU. The figure 2 includes a brief description of each step. The procedure is 
explained in more detail in annex 8.     

8 

Adopted 
Directive 
published in 
EU Official 
Journal

Member States 
transpose the 
legal text into 
national 
legislation by the 
date set in the 
Directive.

7

College of 
Commissioners

The College of 
Commissioners 
adopts the 
proposal and sends 
it to Council and 
European 
Parliament for 
negotiation and 
subsequent 
adoption as a 
Directive.

6 

Draft legislative 
proposal 

DG EMPL prepares 
the draft legislative 
proposal and 
submits it to inter-
service 
consultation. 
Thereafter, a final 
draft legislative 
proposal is 
prepared. 

5 

Impact 
Assessment 
(IA)

DG EMPL drafts IA 
containing policy 
options and 
associated 
impacts. IA is 
discussed within 
an Interservice 
Steering Group 
and submitted to 
the Regulatory 
Scrutiny Board  
(RSB). A positive 
reply is required. 

4 

WPC - ACSH 

The Working Party 
on Chemicals 
(WPC) discusses  
the scientific 
Recommendation 
and various 
feasibility issues 
and comes up 
with a consensus 
based suggestion 
for the OEL value. 
This is integrated 
in a draft opinion 
for adoption by 
the Plenary of 
ACSH. 

3

Two-stage social 
partner 
consultation

According to Article 
154 TFEU. The first 
stage seeks their 
views on the 
possible direction 
of Union action to 
enhance the 
relevance and 
effectiveness of the 
act in question. The 
second stage 
focuses on more 
concrete aspects.

1

Selection of 
chemicals for 
scientific 
evaluation

DG EMPL 
establishes lists of 
priorities for 
scientific 
evaluation based 
on a consultative 
approach, 
including  with 
WPC members, 
and taking into 
account general 
considerations, 
where available.

2

Scientific 
Opinions

DG EMPL issues 
mandates to 
scientific 
committee, who 
will deliver as a 
rule the exposure-
risk-relationships 
(ERR) for non-
threshold 
carcinogens, or a 
practical threshold 
when possible. 
Scientific opinions 
are subject to 
external 
consultation 
before adoption.

Figure 2 : evidence-based procedure supporting legislative initiatives in the area of OSH 

The  social  partners  and  Member  States  play  an  important  role  throughout  this  procedure.  In 
particular, they are involved in the following steps:  

•  Selection  of  chemicals  for  scientific  evaluation:  the  members  of  the  tripartite  ACSH’s 
Working Party on Chemicals make recommendations to the Commission on the substances 
that should be prioritised in the subsequent revisions of the CMRD;  

•  Scientific  opinions:  stakeholders,  including  businesses  and  trade  unions,  are  given  the 
possibility to express their views and concerns in the early phases of developing a scientific 
report on limit values on a substance at the workplace; 

•  Two-stage  social  partners  consultation:  EU  social  partners  are  consulted  on  the  possible 
direction of each initiative and on its content. As part of this two-stage consultation, social 
partners  share  among  other  their  views  on  the  prioritised  substances,  the  suggested 
approaches to address them and the opinions of the ACSH; 

•  ACSH  opinions:  the  ACSH  is  composed  of  three  full  members  per  Member  States, 
representing  national  governments,  trade  unions  and  employers’  organisations.  It  adopts 
opinions  for  each  substance,  in  which  it  recommends  limit  values  or  other  measures  (e.g. 
inclusion of a  process-generated substance in  Annex 1 to  the CMRD). In its opinions, the 
ACSH may recommend transitional measures aiming at giving sufficient time to businesses 
to find technical solutions enabling them to comply with the new limit values or measures. 
The broad composition of the ACSH allows for the covering a large number of sectors and 
activities. This also ensures that its opinions reflect the  current situation of each sector on 
the ground, including in terms of technical and socio-economic feasibility; 

5 

 
•  External study supporting impact assessment: some members of the ACSH’s Working Party 
on  Chemicals  representing  the  three  interest  groups  are  actively  involved  in  the  steering 
committees for the external studies supporting impact assessments. Their practical expertise 
contributes to the quality of the studies and their estimates, including the setting of thorough 
and realistic assumptions.   

This extensive consultation and involvement of relevant stakeholders, in particular the ACSH and 
its  Working  Party  on  Chemicals,  allows  for  effective,  feasible  and  proportionate  regulatory 
measures.  It  also  enables  to  identify  whether  transitional  measures  are  necessary  for  the 
development  of  technical  solutions  allowing  for  compliance  with  these  new  regulatory  measures. 
Annex  2  provides  a  summary  of  stakeholder  consultation  and  their  feedback  that  informed  the 
development of the policy options outlined in this report. 

2.  PROBLEM DEFINITION 

2.1.  What is/are the problems? 

The  REFIT  OSH  evaluation19  concluded  that  the  OSH  directives,  including  the  CMRD,  remain 
highly relevant and effective according to the available evidence. They contributed to the decrease 
in the incidence and number of accidents at work.  

Despite the protective EU legal framework and progress achieved over the last decades, according 
to  estimates,  more  than  170,000  workers  still  lose  their  lives  each  year  due  to  work-related 
illnesses. This shows the need to further improve prevention of work-related diseases in the EU20, 
which has consequences for workers and their families, businesses and public authorities. 

To  address  this  problem,  the  Commission  is  continuously  updating  the  CMRD  to  improve  the 
protection of workers from the exposure to hazardous substances, in particular the 28 carcinogens, 
mutagens  or  reprotoxic  substances  to  be  scientifically  assessed  identified  in  the  Commission’s  
SWD21 published in 2022. These scientific assessments to be carried out by ECHA’s RAC are key 
as  they  provide  most  recent  scientific  data  on  the  hazards  of  a  substance  and  contribute  to  the 
decision of whether further legislative actions are required.   

Providing scientific assessment requires time and resources. It is therefore not possible to address 
these  28  substances  through  one  single  initiative.  Therefore,  the  Commission  has  prioritised  5 
substances, groups of substances or process-generated substances (hereafter ‘substances’)22, namely 
cobalt  and  its  inorganic  compounds,  polycyclic  aromatic  hydrocarbons  (‘PAHs’),  isoprene,  1,4-
dioxane  and  welding  fumes.  The  selection  of  these  5  substances  was  based  on  a  consultative 
approach  including  social  partners  and  Member  States  represented  in  the  WPC,  and  taking  into 
account other considerations, such as 

19 SWD (2017) 10 final, op. cit. 
20  COM/2021/323  final,  op.  cit.,  improving  prevention  of  workplace  accidents  and  illnesses  is  one  of  the  three 
crosscutting key objectives identified in the EU OSH strategic framework   
21 SWD (2022) 438 final, op. cit. 
22 More information on the selection of the substances considered in this impact assessment is available in annex 9. 

6 

 
 
•  Cobalt and its inorganic compounds: legal obligation23 under CMRD 4 to set limit values 
for  cobalt  and  importance  to  improve  workers’  protection  from  a  substance  whose 
consumption is expected to increase by 330% by 2050 with the green transition. 
•  PAHs: high number of workers potentially exposed to this group of substances. 
•  1,4-dioxane: recent classification as carcinogen 1b in the CLP Regulation. 
• 
Isoprene: high number of Member States with no national limit value. 
•  Welding  fumes:  high  number  of  workers  potentially  exposed  to  these  process-generated 
substances  and  absence  of  classification  at  EU-level  in  the  CLP  Regulation  despite  the 
IARC classification from 2018, see section 2.2.2.   

According  to  the  evidence  gathered,  including  scientific  and  socioeconomic  data,  workers, 
businesses and Member States are impacted by the insufficient prevention of occupational exposure 
to  cobalt  and  its  inorganic  compounds,  PAHs,  1,4-dioxane  and  welding  fumes.  Conversely,  the 
evidence gathered indicates that workers are exposed to levels of isoprene which are lower than the 
health-based limit value24 derived by RAC in its opinion25, suggesting that the current prevention of 
occupational exposure to isoprene is sufficient.  

For workers, the insufficient prevention may lead to serious health problems, including cancer. The 
table  1  below  presents  estimates  of  the  number  of  cancer  and  other  ill-health  cases  occurring  in 
2023  due  to  past  workers’  exposure  (current  disease  burden)  and  over  the  next  40  years  due  to 
future exposure (future disease burden). For cancer cases, welding fumes, PAHs and cobalt and its 
inorganic compounds are the most problematic. For example, workers’ exposure to welding fumes 
alone would lead to close to 30,000 lung cancer cases over the next 40 years. Although no cancer 
case  is  expected  for  1,4-dioxane,  workers’  exposure  to  this  substance  causes  other  diseases  as 
shown in table 1. More information on trends used for estimates is provided in section 5.   

Table 1: estimates on number of workers exposed in the EU and estimated current and future burden of 
disease 

Substance 

Estimated 
number of 
workers 
exposed in 
the EU 

Most critical adverse health 
effects  

Estimated 
current burden 
of disease 
(number of 
cases/year in 
2023) 

Estimated future 
burden of disease 
(number of cases 
over the next 40 
years) 

Cobalt and 
inorganic cobalt 
compounds 

Polycyclic 
aromatic 
hydrocarbons 

111,300  

Lung cancer 

Restrictive lung disease 

Upper airway irritation 

1,284,052 

Lung cancer 

Developmental toxicity  

Male fertility 

12 

100 

350 

5 

1 

78 

76 

4,365 

14,152 

160 

38 

3,157 

23 As part of the fourth revision of the CMRD, the European Parliament and the Council  requested that “no later than 
31  December  2024,  the  Commission  shall,  taking  into  account  the  latest  developments  in  scientific  knowledge,  and 
after  appropriate  consultation  of  relevant  stakeholders,  where  appropriate,  a  limit  value  for  cobalt  and  inorganic 
cobalt compounds”.  
24 Level of exposure that is considered to be safe (health-based) for a chemical substance in the air of a workplace. 
25 RAC (2022), op. cit.  

7 

 
 
1,4-Dioxane 

31,150 

Liver cancer 

Liver effects 

Kidney effects 

0 

16 

12 

Isoprene 

10,539 

Liver cancer  

0.007  

Local respiratory effects 

110 

Degeneration of olfactory 
epithelium 

Degeneration of spinal cord 
white matter 

0 

0 

0 

633 

497 

4,382 

0.03 

0 

0 

Welding fumes 

1,200,000 

Lung cancer 

879 

28,821 

Respiratory tract toxicity 
(incl. acute pneumonia and 
asthma)   

No data available  No data available  

Source: RPA (2024) 

For businesses, work-related diseases (cancer and other diseases) imply costs, including in terms of 
reduced  productivity.  Given  the  often-long  time  lag  between  exposure  and  illness  and  the 
probability of workers changing employers during their work career, the risk of future productivity 
losses  is  unlikely  to  be  internalised  by  companies,  and  therefore  not  factored  into  present 
businesses’  decisions.  The  table  below  includes  an  estimate  of  the  costs  to  employers  for  the  5 
substances  subject  to  this  impact  assessment,  which  includes  the  cost  due  to  insurance  payments 
and absence from work, and the productivity loss due to mortality.  

In addition to significant social and financial burden to those affected by work-related diseases and 
deaths,  the  diseases  are  also  associated  with  significant  costs  to  society.  For  public  authorities, 
work-related diseases lead to  increased healthcare costs related to  treatment  and rehabilitation, as 
well  as  to  higher  expenditure  on  associated  inactivity  and  early  retirement  and  compensation  for 
recognised occupational  diseases. According to  estimates26, direct  costs of work-related cancer in 
terms of healthcare and productivity losses at the EU level are between €4 – 7 billion per year; and 
the indirect costs may reach between €242 and €440 billion each year. The table below includes an 
estimate  of  the  costs  to  public  authorities  for  the  5  substances  subject  to  this  impact  assessment, 
which includes healthcare costs and loss of tax revenues.  

Table 2: costs of ill-health for businesses and public administration (in € million, over 40 years) 

Businesses 

Public administration 

Cobalt and its inorganic 
compounds 

Polycyclic aromatic 
hydrocarbons 

1,4-dioxane 

€1.60 

€0.61 

€1.58 

€8.12 

€5.51 

€1.98 

26  The  Netherlands’  National  Institute  for  Public  health  and  the  Environment  (2016),  Work-related  cancer  in  the 
European Union, RVIM Letter report 2016-0010. 

8 

 
 
 
 
Isoprene 

Welding fumes 

TOTAL 

Note: 3% static discount rate  

€0.00 

€103 

€106.79 

€0.00 

€363 

€378.61 

The  problem  tree  below  presents  the  identified  problem,  as  well  as  its  drivers  and  consequences. 
The  problem  and  its  drivers  are  further  described  above.  More  detailed  information  on  the  four 
identified drivers is provided in the next section.  

s
r
e
v
i
r
D

l

m
e
b
o
r
P

s
e
c
n
e
u
q
e
s
n
o
C

Driver 1:  
▪  High occupational exposure levels to  
cobalt and its inorganic compounds, 
PAHs, 1,4-dioxane and welding fumes 

Driver 2: 

Misalignment of the EU Regulatory 
framework with the latest scientific 
data  

Driver 3:  
▪  Disparate levels of protection at 

national level 

Driver 4: 

▪ Insufficient awareness of the possible 

dangerousness of welding fumes 

Insufficient prevention in the EU to reduce prevalence of work-related diseases 

For businesses: 

For Member States:  

For workers:  

▪ Absence for health 
reasons, need for staff 
replacement, loss of 
experience  
▪ Reduced staff 
productivity  
▪ Unlevel playing field 

▪ Higher social security 
costs 
▪ Forgone tax revenues 
▪ GDP loss 

▪ Premature death and 
health problems  
▪ Reduced quality of life 
▪ Higher health related 
costs 
▪ Reduced family income 

2.2.  What are the problem drivers? 

Figure 3: problem tree 

2.2.1.  Driver 1: high exposure levels to cancer-causing substances  

As  shown  in  section  1,  cancer  is  the  main  cause  of  work-related  diseases  and  deaths  in  the  EU. 
Substances classified as carcinogenic can also cause other diseases. For instance, exposure to PAHs 
can lead to male infertility and developmental toxicity.  

9 

 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
According to the evidence gathered27, more than 2.6 million workers in the EU are exposed today 
to  the  5  substances  considered  in  this  impact  assessment.    In  order  to  adequately  protect  their 
workers,  employers  have  to  perform  a  risk  assessment  and  implement  the  necessary  risk 
management  measures  (RMMs).  The  type  of  RMMs  required  depends  on  several  factors  such  as 
the nature of the work, the levels of exposure or the duration of exposure.  

Today, some workers are still exposed to levels of substances that are too high and might lead to 
hazardous health problems, including cancer, as summarised in table 1. For instance, the evidence 
gathered indicates that workers operating in the manufacture of tools sector are exposed on average 
to 4.8 µg cobalt/m³ (inhalable fraction), while in 1% of these workers are exposed to levels higher 
than  27.9  µg  cobalt/m³  (inhalable  fraction).  These  levels  are  higher  than  the  health-based  limit 
value  of  1  µg/m³  (inhalable  fraction)  derived  by  RAC  in  its  opinion28,  which  corresponds  to  the 
value below which the health risk for workers is nonexistent.  

Conversely,  the  evidence  gathered29  indicates  that  the  current  levels  of  workers’  exposure  to 
isoprene  are  lower  than  the  threshold  limit  value  derived  by  RAC  in  its  opinion30.  Therefore, 
workers exposed to isoprene in the EU are not expected to experience adverse health effects. More 
information  on the  current  exposure levels  of workers  to  cobalt, PAHs, 1,4-dioxane  and  isoprene 
are available in annex 6. 

These estimates of cancer and non-cancer cases reflect the insufficient RMMs currently in place in 
some sectors or companies resulting in some workers being exposed to hazardous levels. Following 
a survey31 conducted for the purpose of this impact assessment,  businesses indicated if additional 
RMMs would be necessary to comply with certain limit values.  

To continue with the example of manufacturing of tools sectors, 30% of the respondents indicated 
that  30%  of  processes  are  fully  enclosed,  20%  partially  enclosed,  20%  have  open  hood  systems, 
10% have high efficiency particulate air (HEPA) filters and for the remaining 20%, workers wear 
simple  masks.  According  to  these  respondents,  complying  with  the  health-based  limit  value  for 
cobalt would  require  additional RMMs,  in  particular  fully enclosed systems  (33%). Only 10% of 
the  processes  would  not  require  any  additional  RMMs.  More  information  on  the  current  and 
required RMMs for complying with certain limit values is provided in Annex 6. 

In  conclusion,  the  insufficient  take-up  of  the  relevant  RMMs  results  in  workers  exposed  to 
hazardous levels of carcinogenic substances.   

2.2.2.  Driver 2: misalignment of the EU Regulatory framework with the latest scientific 

data 

Article  16  of  the  CMRD  provides  that  EU-wide  limit  values  should  be  established  for  all  those 
carcinogens,  mutagens  or  reprotoxic  substances  for  which  the  available  information  makes  this 
possible. Indeed, EU-wide limit values must be regarded as an important component of the general 

27 RPA (2024), op. cit.  
28 RAC (2022), Opinion on scientific evaluation of occupational exposure limits for cobalt and inorganic cobalt 
compounds, available at: 
https://echa.europa.eu/documents/10162/7937606/final_rac_oel_opinion_cobalt_en.pdf/d96755b2-8bd0-afe7-ab94-
0a2f263fc593?t=1675065309296 
29 RPA (2024), isoprene report, section 3.12 
30 RAC (2022), op. cit.  
31 RPA (2022), op. cit., stakeholder 

10 

 
 
arrangements  for  the  protection  of  workers.  They  provide  clear  benchmark  for  employers  when 
implementing RMMs so workers’ exposure cannot exceed limit values. 

Despite the existence of EU-wide limit values for 39 hazardous substances within the CMRD, the 
following  three  substances  subject  to  this  assessment  do  not  have  yet  a  binding  EU  limit  value 
although scientific data are available: cobalt and inorganic cobalt compounds, polycyclic aromatic 
hydrocarbons, 1,4-dioxane.  

The  necessary  scientific  data  was  provided  by  RAC  in  substance-related  opinions  in  2022.  A 
summary  of  this  scientific  information  is  provided  in  annex  2.  These  opinions  provide  all  the 
necessary  information  to  establish  limit  values  in  the  CMRD,  as  required  by  Article  16  of  the 
CMRD.  

The misalignment of the CMRD with the latest available scientific data may affect its effectiveness 
with insufficient RMMs in place in some sectors. As a result, workers are more likely to be exposed 
to too high levels of these 4 substances. More details on exposure levels are provided in section 5.  

2.2.3.  Driver 3: disparate or inexistant limit value at national level  

While employers must comply with their minimisation obligations stemming from Articles 4 and 5 
of the CMRD in all cases, limit values provide very relevant benchmarks enabling them to know 
exactly  the  levels  above  which  exposure  cannot  occur.  Limit  values  also  allow  employers  to 
determine  the  level  below  which  their  RMMs  should  ensure  compliance  with  the  obligation  to 
reduce  the  exposure  to  as  low  a  level  as  it  is  technically  possible.  Likewise,  limit  values  support 
enforcement  authorities  in  controlling  that  employers  are  putting  in  place  the  relevant  RMMs, 
including those that could contribute to lower the exposure below the limit values. 

The  absence  of  EU-wide  binding  limit  values  for  the  three  substances  does  not  prevent  Member 
States  to  establish  their  own  national  limit  values.  According  to  the  evidence  gathered32,  several 
Member  States  have  already  set  binding  limit  values  for  one  or  several  of  these  substances.  The 
table  below  includes  the  lowest  and  highest  existing  binding  OELs  in  Member  States  for  each 
substance, as well as the number of Member States with no binding OEL. More information on the 
current national OELs is available in Annex 6. 

Table 3: national binding limit values in EU Member States 

Hazardous substance 

inorganic 

Cobalt  and 
cobalt compounds 
PAHs 

1,4-Dioxane 

Lowest (strictest) 
national binding 
OEL 
10 µg/m3 
DK 
70 ng/ m3 
DE 

20 mg/m3 
LV, NL 

Highest (least strict) 
national binding 
OEL 
500 µg/m3 
LV 
200,000 ng/m3 
DK, ES, RO 

73 mg/m3 
AT, BE, BG, CY, DE, 
EE, EL, ES, FR, HR, 

Member States with 
no binding OEL 

5 
IT, LU, MT, PT, SI 
933 
BE, CY, FI, FR, IE, IT, 
LU, MT, PT 
334 
FI, IE, PT 

32 RPA (2024), op. cit. 
33 The evidence gathered does not indicate if the OEL set in Austria is binding or indicative. 
34  The  evidence  gathered  does  not  indicate  if  the  OEL  set  in  Malta  is  binding  or  indicative.  FI,  IE  and  PT  have  an 
indicative limit value for 1,4-dioxane. 

11 

 
 
Source: RPA (2024) 

HU, IT, LU, RO, SI, SK 

A high number of Member States have currently no binding OEL for PAHs. With regard to cobalt 
and inorganic cobalt compounds and 1,4-dioxane, a significant number of Member States already 
have an OEL. However, the OELs currently in place in most of the Member States are much higher 
than  the  values  recommended  by  RAC  and  hence  likely  not  sufficiently  effective  for  protecting 
workers’ health. Furthermore, diverging limit values across the EU result in an unlevel playing field 
within the single market. Indeed, businesses operating in Member States with more stringent limit 
values will have to bear higher costs than their competitors subject to less strict rules. Aside from 
improving  workers’  protection  to  exposure  to  hazardous  substances  at  the  workplace,  employers’ 
representatives  are of the opinion that  setting  binding limit  values at  EU level  helps  to  provide a 
level playing field for industry35.     

An  inadequate  OEL  creates  no  incentive  for  the  implementation  of  the  most  modern  production 
technologies  and  RMMs  allowing  for  a  reduction  of  the  occupational  exposure  to  hazardous 
substances.  

The  evidence  gathered36  suggests  that  some  companies  would  invest  in  more  effective  RMMs  if 
they would have to operate under stricter OELs.  

2.2.4.  Driver  4:  insufficient  awarness  of  the  possible  dangerousness  of  welding 

fumes 

In  2018,  IARC  classified  welding  fumes  and  UV  radiation  from  welding  as  “carcinogenic  to 
humans”  (Group  1).  Exposure  to  welding  fumes  may  lead  to  lung  damage  and  various  types  of 
cancer, including of the lung, larynx and urinary tract. As process-generated substances and despite 
the IARC classification, welding fumes are not classified according to the CLP Regulation.  

As  mentioned  by  ECHA  in  its  scoping  study37,  welding  fumes  are  complex  and  have  variable 
compositions. The content of welding fumes depends largely upon the materials being welded. The 
majority  (95%)  of  the  components  of  welding  fumes  are  emitted  from  the  fillet  or  consumables 
used and only 5% from the base material38.  

The  dangerousness  of  welding  fumes  depends  also  on  the  process  used,  as  shown  in  the  ECHA 
scoping study. For instance, beam welding39 is unlikely to lead to workers’ exposure as it is almost 
completely  automated  while  arc  welding40  workers  are  likely  to  be  exposed  to  carcinogens, 

at: 

35  BusinessEurope  (2017),  Seconde  phase  consultation  of  social  partners  under  Article  154  TFEU  on  revisions  of 
Directive 2004/37/3EC to include binding occupational exposure limit values for additional carcinogens and mutagens, 
available 
https://www.businesseurope.eu/sites/buseur/files/media/position_papers/social/2017-12-
20_carcinogens_and_mutagens_-_2nd_phase_social_partner_consultation_final_response.pdf.  
36 RPA (2024), op. cit.  
37 ECHA (2022), Scoping Study report for evaluation of limit values for welding fumes and fumes from other processes 
that generate fume in a similar way at the workplace, available at: report_welding_fumes_en.pdf (europa.eu) 
38 ANSES, Agence national de sécurité sanitaire de l’alimentation, de l’environnement et du travail (2022), Collective 
expert  appraisal :  summary  and  conslusions  –  Identification  of  works  or  processes  to  be  included  in  the  Order 
establishing the list of carcinogenic substances, mixtures or processes work involving exposure to welding fumes.  
39 Beam welding can be divided in two categories: laser bearm and electron beam.  Laser welding is a process used to 
join  together  metals  using  a  laser  beam  to  form  a  weld.  Electron  beam  (EB)  welding  is  a  fusion  welding  process 
whereby electrons are generated by an electron gun and accelerated to high speeds using electrical fields. 
40 This type of welding process uses an electric arc to create heat to melt and join metals. 

12 

 
 
particularly in the craft sector where automated process is less prevalent. A summary of the welding 
processes,  the  generated  substances,  the  indication  of  the  presence  of  carcinogens,  mutagens  or 
reprotoxic substances, and the workers’ exposure is available in Annex 6.   

Due  to  the  complexity  and  heterogeneity  of  the  composition  of  welding  fumes,  as  well  as  the 
absence of harmonised classification in the CLP Regulation, employers might ignore that the fumes 
generated by their welding activities might include carcinogens, mutagens or reprotoxic substances. 
Consequently, those employers might not carry out the mandatory risk assessment provided in the 
CMRD  when  workers  are  or  are  likely  to  be  exposed  to  carcinogens,  mutagens  or  reprotoxic 
substances as a result of their work. In the absence of such a risk assessment, employers might not 
implement  all  necessary  risk  management  measures  to  comply  with  the  CMRD  and  adequately 
protect their workers.  

The  evidence  gathered41  confirms  that  some  employers  are  not  aware  that  welding  fumes  may 
contain carcinogens, mutagens or reprotoxic substances (such as chromium (VI) compounds, nickel 
compounds,  cadmium  and  its  inorganic  compounds,  and  beryllium  and  its  inorganic  compounds) 
and  lead  to  health  risks.  Further,  according  to  the  evidence  gathered,  this  lack  of  awareness  is 
considered as an important driver by stakeholders42.   

These  employers  may  therefore  ignore  to  what  extent  exposure  to  their  welding  processes  and 
materials used can be carcinogenic, mutagenic or reprotoxicant for their workers and do not apply 
the  measures  prescribed  by  the  CMRD  to  protect  workers.  According  to  the  evidence  gathered43, 
the  improvement  of  risk  management  measures  following  the  introduction  of  welding  fumes  in 
Annex I to the CMRD will concern about 1% of workers involved in welding activities44.  

As a consequence of the legal unclarity, and despite the fact that welding can be a relatively safe 
activity if all the safety and exposure control measures are in place, it remains a prominent concern 
that welders are at high risk from various diseases, including cancers45 (see Table 1). In the absence 
of  sufficient  data,  the  geographical  distribution  of  the  level  of  compliance  with  the  CMRD  in 
individual Member States cannot be provided.  

2.2.5.  Driver 5: lack of inspections for non-compliance with the CMRD  

The lack of inspections was also identified as a  driver of the insufficient prevention in the EU to 
reduce prevalence of work-related diseases due to welding fumes-related activities46. However, as 

41 RPA(2024), op. cit., views collected from six key stakeholders representing a large number of welders in the EU. All 
stakeholders were granted anonymity to share information.  
42 RPA(2024), op. cit., interview carried out with key stakeholders (interviews with three key EU level and three key 
national stakeholders (from Germany, Greece and Italy). The results of another survey conducted with twelve national 
stakeholders (from Croatia, Estonia, France, the Netherlands and Slovenia), comprising one company, two trade unions, 
three  OSH  experts  and  six  training/trade  associations,  indicate  that  the  estimated  level  of  awareness  of  CMRs  in 
welding fumes in their members, employees, or students ranged widely from 20-100%. All stakeholders were granted 
anonymity to share information. 
43 RPA (2024), op. cit. 
44 RPA(2024), op. cit., this estimate was not contradicted by key stakeholders following their interviews carried out as 
part of data collection activities. It assumes that some organisations (such as larger enterprises) will already be applying 
best  practice  measures  and  will  not  need  to  change  their  practices.  Other  organisations  will  not  be  applying  best 
practice measures, but of these some might not be aware of a policy change. 
45 ECHA (2022), op. cit.  
46  RPA(2024),  op.  cit.,  a  report  on  inspections  undertaken  in  the  Netherlands  from  2009  to  2015  found  217 
infringements of the OSH risk of exposure to welding fumes. 

13 

 
 
labour inspection is  a prerogative of Member States and cannot  be addressed by the CMRD, this 
driver was not reflected in the intervention logic.   

2.3.  How likely is the problem to persist? 

In  the  absence  of  action  at  EU  level,  workers  exposed  to  cobalt  and  its  inorganic  compounds, 
PAHs,  1,4-dioxane  or  welding  fumes  are  expected  to  continue  to  be  at  risk  of  contracting  work-
related cancer and other adverse health effects. Estimates on the number of future ill-health cases 
are provided in table 4. Additional information, including the monetised health costs in case of no 
EU action (baseline scenario), are provided in section 5.  

The general obligations set by the CMRD, employers’ actions and the corresponding implementing 
measures  adopted  by  Member  States  contribute  overall  to  lowering  exposures.  According  to  the 
evidence gathered47, exposure levels  to  the  five substances  have generally  been decreasing  in  the 
past  years  and  this  positive  trend  is  expected  to  continue  in  the  future  for  PAHs  and  welding 
fumes48. Substitution may be possible for some chemicals and uses in the future and technological 
developments could lower exposure concentrations. Furthermore, the number of workers employed 
in  the  industries  using  these  carcinogens  may  change,  as  further  described  in  section  5.  Despite 
these  trends,  the  insufficient  prevention  of  work-related  diseases  occurring  from  the  exposure  to 
these 4 substances is expected to persist.  

Future forecasts in this  area are however far from certain due to scarcity of relevant data and the 
fact that market forces such as raw material and energy prices, developing technology, as well as 
regulatory  changes can  drive decreases or increases in  use which are not easy to  predict. Even if 
trends  were  overall  positive,  the  existing  employers’  practices  as  well  as  protective  measures  at 
Member State level do not always reflect  the most recent scientific and technological knowledge. 
For that reason, the retained assumptions are based on the legal provisions contained in the CMRD, 
including  the  minimisation  requirements,  on  information  gathered  from  the  stakeholders  (via 
targeted  consultations),  as  well  as  on  the  expertise  of  the  employers,  workers  and  government 
representatives  that  steered  the  supporting  study  (RPA  2024)  analysis.  The  objective  has  been  to 
define a baseline scenario as close as possible to the future situation. More information about the 
past and future trends that would influence the future burden of disease is available in section 5.1. 

Member  States  usually  do  not  inform  the  Commission  on  their  intentions  to  revise  existing  or 
determine new OELs in their national legislation. However, national administrations represented in 
the ACSH are aware of the preparatory work at EU level and therefore it is likely they will await its 
results in order not to duplicate efforts. 

Table 4: estimated future burden of disease over 40 years 

Hazardous substance 

Estimated cancer cases 

Cobalt and inorganic cobalt 
compounds 

•  Lung cancer: 76 

Polycyclic aromatic 
hydrocarbons 

•  Lung cancer: 160 

Estimated cases of other 
adverse health effects 

•  Restrictive lung disease: 4,365 
•  Upper 
irritation: 
airway 
14,152 

•  Developmental toxicity: 38 
•  Male infertility: 3,157 

47 RPA (2024), op. cit. 
48 More information on future trends is available in section 5 of this impact assessment.  

14 

 
 
1,4-dioxane 

•  Liver cancer: 0 

•  Liver effects: 633 
•  Kidney effects: 497 
•  Effects in nasal cavity: 4,381 

Welding fumes  

•  Lung cancer: 28,821 

No data available  

Source: RPA (2024) 
Note: key trends supporting the above estimates are provided in section 5. 

3.  WHY SHOULD THE EU ACT? 

3.1.  Legal basis 

Article 153 of TFEU49 empowers the EU to support and complement the activities of the Member 
States as regards improvements, in particular of the working environment to protect workers' health 
and  safety  and 
to  adopt,  by  means  of  directives,  minimum  requirements  for  gradual 
implementation,  having  regard  to  the  conditions  and  technical  rules  obtaining  in  each  of  the 
Member States.  

On the basis of this provision, Article 16 of the CMRD sets out that limit values are to be adopted 
in  respect  of  those  carcinogens,  mutagens  or  reprotoxic  substances  for  which  this  is  possible, 
having regard to the available information, including scientific and technical data. 

3.2. 

Subsidiarity: Necessity of EU action 

Cancer  can  affect  every  citizen  in  one  way  or  another,  regardless  of  their  country  of  origin  or 
residence.  Faced  with  this  issue,  the  Commission  adopted  in  2021  its  Europe’s  Beating  Cancer 
Plan50. In this plan, the Commission recognises the need to mobilise the collective power of the EU 
to drive change to the benefit of the EU citizens.  

As part of this plan, the Commission highlighted the need to reduce the exposure to carcinogens at 
the workplace, through the revision of the CMRD.  It is in line with the REFIT OSH evaluation51 
which  considers  the  CMRD  of  high  relevance  to  protect  workers  at  the  EU  level.  According  to 
contributions  received  from  national  and  EU  stakeholders  during  that  evaluation  process,  further 
occupational limit values should be established at the EU level.  

A  consistent  level  of  protection  from  the  risks  related  to  carcinogens,  mutagens  or  reprotoxic 
substances  must  be  established  for  the  EU  as  a  whole  by  a  framework  of  general  principles  to 
enable Member States to apply the minimum requirements consistently. Action at EU level ensures 
that all workers within the EU will benefit from a similar high level of protection, in line with the 
latest scientific evidence.  

EU-wide limit values must be regarded as an important component of the general arrangements for 
the protection of workers. Article 16 of the CMRD provides that EU-wide limit values should be 
established  for  all  those  carcinogens,  mutagens  of  reprotoxic  substances  for  which  the  available 

49 OJ C 326, 26.10.2012, p. 47-390 
50 Communication from the Commission to the  European Parliament and the Council Europe’s Beating Cancer Plan, 
COM/2021/44 final 
51 SWD (2017) 10 final, op. cit. 

15 

 
 
 
information  makes  this  possible.  Following  the  request  from  the  European  Parliament  and  the 
Council  made  as  part  of  the  fourth  revision  of  the  CMRD,  the  Commission  published  in  2022  a 
SWD52 listing 28 priority chemicals for scientific assessment in view of the subsequent revisions of 
the CMRD. Among them are the 5 substances subject to this impact assessment.  

As  shown  in  table  4  above,  future  occupational  exposure  to  cobalt  and  its  inorganic  cobalt 
compounds, PAHs and welding fumes is expected to result in more than 30,000 cancer cases over 
40  years.  Therefore,  it  is  urgent  to  improver  workers’  protection  from  the  exposure  to  these  4 
substances, in line with the Europe’s Beating Cancer Plan. With regard to 1,4-dioxane, no cancer 
cases are expected from occupational exposure over the next 40 years. However, workers’ exposure 
to  this substance can lead to  other diseases  which represent  a  burden for workers, employers and 
Member States across the EU, justifying an action at EU level.  

As for the fifth substance, isoprene, the evidence gathered53 indicates the current and future levels 
of  workers’  exposure  are  already  lower  than  the  health-based  limit  value  derived  by  RAC  in  its 
opinion54. Despite the unanimous support of representatives from businesses, workers and Member 
States within the ACSH for setting a limit value for isoprene, an action at EU level does not seem 
necessary for improving workers’ protection.  

3.3. 

Subsidiarity: Added value of EU action 

Improved clarity and enforcement 

Establishing  limit  values  for  cobalt  and  inorganic  cobalt  compounds,  polycyclic  aromatic 
hydrocarbons  and  1,4-dioxane  will  provide  common  reference  points  that  are  used  as  a  practical 
tool  by  employers,  workers  and  enforcers  to  assess  compliance  with  the  general  requirements,  in 
particular in those Member States with no existing  limit values. Limit values can also be used by 
process  plant  and  machinery  designers  when  planning  new  or  considering  alterations  to  existing 
process plants.  

The complexity and heterogeneity of the composition of welding fumes, together with the absence 
of  harmonised  classification  for  welding  fumes  in  the  CLP  Regulation,  contribute  to  a  lack  of 
clarity  on  the  possible  dangerousness  of  welding  fumes  for  workers,  and  therefore  a  lack  of 
appropriate RMMs. Addressing this absence of classification for welding fumes at EU level would 
ensure more legal clarity, which would result in better implementation of the existing rules. 

Governments’,  employers’  and  workers’  representatives  have  expressed  clear  support  for 
establishing limit values for the substances subject to this initiative, and including welding fumes in 
Annex I to the CMRD, as it clearly results from the two-stage consultation of social partners and 
the  opinions  of  the  tripartite  ACSH.  Detailed  information  on  the  outcome  of  the  social  partners 
consultation and the ACSH opinions is available in annex 2.  

Ensuring a similar minimum level of protection across the EU  

52 SWD(2022) 438, op. cit. 
53 RPA (2024), op. cit. 
54 RAC (2022), op. cit.  

16 

 
 
The CMRD aims  to  improve workers’ health by  protecting against risks  arising  or likely  to  arise 
from exposure to carcinogens, mutagens or reprotoxic substances at work. This objective is in line 
with the and Europe’s Beating Cancer Plan55. 

Limit  values  under  the  CMRD  are  an  important  component  of  the  general  arrangements  for  the 
protection of workers56 and should be established for all those carcinogens and mutagens for which 
the available information makes this possible.  

The CMRD does not  prevent  Member States to  adopt  national  limit  values in  the absence of EU 
values. However, the national limit values for the 3 substances subject to the setting of a limit value  
may  vary  considerably  between  Member  States,  where  they  exist.  For  instance,  and  as  set  out  in 
table 3, the national limit values for cobalt range from 10 to 500 µg/m3. Some Member States have 
therefore set limit values fifteen times lower than others for the same substance, while five Member 
States have no limit values for cobalt57. In the absence of any action at the EU level, very different 
levels of workers’ protection are likely to persist.  

Contribution to a more levelled playing field 

Some  employers'  organisations  stressed  in  their  response  to  the  social  partner  consultation  that 
setting EU limit values helps to provide a level playing field for industry. The costs of complying 
with  lower  national  levels  are  generally  higher  and  entail,  therefore,  a  competitive  advantage  for 
enterprises operating in markets with no or less stringent national limit values. 

Setting EU limit values will not completely eliminate the differences between Member States since 
they  can  adopt  more  protective  (lower)  limits.  However,  it  will  reduce  the  scope  for  divergences 
and  enhance  certainty  that  there  is  a  core  definition  and/or  enforceable  exposure  limit  for  all 
concerned  carcinogens  in  all  Member  States.  It  will  also  reduce  regulatory  complexity  resulting 
from  highly  diverging  rules  between  Member  States,  contributing  to  reduce  the  administrative 
burden of compliance for businesses operating across the single market. 

Reducing burdens related to derivation of limit values 

The  process  of  establishing  limit  values  is  very  complex  and  requires  a  high  level  of  scientific 
expertise,  as  well  as  an  impact  assessment  and  discussions  with  the  stakeholders  (depending  on 
national  practices).  An  important  advantage  of  setting  OELs  at  EU  level  is  that  it  eliminates  the 
need for Member States to conduct their own analysis, including scientific assessment, with likely 
substantial savings on administrative costs.  

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

4.1.  General objectives 

This initiative contributes to the improvement of health and safety of workers pursuant to Article 
153  of  the  TFEU.  It  aims  at  complying  with  the  legal  obligations  laid  down  in  Article  16  of  the 

55 COM/2021/44 final, op. cit. 
56 Recital 13 of Directive 2004/37/EC 
57 IT, LU, MT, PT, SI 

17 

 
 
CMRD related to the setting of limit values, and to prevent work-related deaths and diseases in line 
with the second key objective of the EU OSH strategic framework58. 

This report evaluates the impact of setting limit values for cobalt and inorganic cobalt compounds, 
PAHs and 1,4-dioxane, as well as to include welding fumes in the Annex I to the CMRD for the 
purpose of legal clarity. As no problem with workers’ exposure to isoprene was identified, the main 
report  does  not  include  any  assessment  of  options  for  limit  values.  However,  as  the  ACSH 
recommended a limit value for isoprene, a thorough assessment of this option is provided in Annex 
10. 

4.2. 

Specific objectives 

The specific objectives are:  

•  To  further  improve  workers’  protection  from  exposure  to  cobalt  and  its  inorganic 
compounds,  PAHs  and  1,4-dioxane  in  the  EU  through  the  adoption  by  employers  of 
appropriate risk management measures;  

•  To  increase  the  clarity  and  effectiveness  of  the  CMRD  by  keeping  it  up  to  date  with  the 

latest scientific data allowing the establishment of limit values;  

•  To  facilitate  implementation,  and  contribute  towards  a  better  level  playing  field  for 
economic  operators  by  adopting  minimum  requirements  at  the  EU  level  that  apply  to  all 
businesses, irrespective of their location;  

•  To  bring  more  clarity  on  the  scope  of  the  CMRD  with  regard  to  welding  fumes  so  that 
businesses  perform  the  mandatory  risk  assessment  and  apply,  if  workers  are  likely  to  be 
exposed  to  carcinogens,  mutagens  or  reprotoxicants  according  to  the  risk  assessment,  all 
requirements when these fumes contain carcinogens, mutagens or reprotoxic substances. 

The specific objectives of the initiative are relevant for the sustainable development goals59 on good 
health and well-being (3rd goal) and decent work and economic growth (8th goal). 

4.3.  Consistency with other EU policies 

4.3.1.  Charter of Fundamental Rights of the EU 

The objectives of the initiative are consistent with Article 2 (Right to life) and Article 31 (Right to 
fair and just working conditions) of the EU Charter of Fundamental Rights60. 

4.3.2.  REACH Regulation 

The  Regulation  concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of 
Chemicals61  (‘REACH  Regulation’),  entered  into  force  in  2007,  establishes  among  others  two 
distinct EU regulatory approaches that are restrictions and authorisations.  

The  applicable  provisions  of  REACH  authorisation  or  restriction  of  cobalt  and  its  inorganic 
compounds,  PAHs  and  1,4-dioxane  are  summarised  in  the  table  below.  As  process-generated 

58 COM/2021/323 final, op. cit. 
59 United Nations resolution entitled ‘Transforming our World: the 2030 Agenda for Sustainable Development, adopted 
at the UN Sustainable Development Summit on 25 September 2015 in New York 
60 OJ C 202, 7.6.2016, p. 389-405 
61 OJ L 396, 30.12.2006, p. 1-849 

18 

 
 
substances,  restrictions  and  authorisations  within  the  meaning  of  REACH  are  not  applicable  to 
welding fumes.  

Substances 

Cobalt and 
inorganic cobalt 
compounds 

PAHs 

Table 5: applicable provisions of REACH authorisation or restriction 

Restriction 

Authorisation 

No existing restrictions 

No existing authorisations 

No existing authorisations  

Existing restriction concerning the 
use of certain products that may 
contain one or more PAH 
substances62.  

Existing restriction concerning the 
use of creosote and creosote 
containing substances in wood 
treatment.  

1,4-dioxane 

No existing restrictions 

Substance included in the Substance 
of Very High Concern (SVHC) 
Candidate List for Authorisation63 
according to REACH Art. 57 (a) and 
57 (f), with this triggering 
substitution and information 
requirements. 

None  of  the  existing  REACH  restrictions  set  work-related  limit  values  for  cobalt  and  inorganic 
cobalt  compounds,  PAHs  or  1,4-dioxane.  Therefore,  there  is  no  overlap  between  the  initiative 
subject  to  this  impact  assessment  and  the  existing  restrictions  under  REACH.  Furthermore,  the 
relevant  services  within  the  Commission  will  ensure  a  successful  complementarity  between 
REACH  and  OSH  legislations  in  case  of  future  action  under  REACH  for  any  of  the  substances 
subject  to  this  impact  assessment.  More  information  related  to  the  REACH  requirements  for 
substances subject to this impact assessment is available in annex 10.  

4.3.3.  Europe’s Beating Cancer Plan  

The aim of Europe’s Beating Cancer Plan64 is to tackle the entire disease pathway. It is structured 
around  four  key  action  areas  where  the  EU  can  add  the  most  value:  (1)  prevention;  (2)  early 
detection; (3) diagnosis and treatment; and (4) quality of life of cancer patients and survivors.  

62  Benzo[a]pyrene,  Benzo[e]pyrene,  Benzo[j]fluoranthene,  Benzo[a]anthracene,  Chrysene,  Dibenzo[a,h]anthracene, 
Benzo[k]fluoranthene and Benzo[b]fluoranthene 
63 Decision of ECHA dated 23.06.2021 on the inclusion of substances of very high concern in the Candidate List for 
eventual inclusion in Annex XIV, available at: ECHA decision on inclusion in Candidate List (europa.eu) 
64 COM/2021/44 final, op. cit. 

19 

 
 
 
 
The  occupational  exposure  to  the  five  substances  subject  to  this  initiative  can  cause  cancer,  as 
outlined  in  section  2.1.  Therefore,  addressing  them  through  the  setting  of  limit  values  or  an 
inclusion in the scope of the CMRD will contribute to preventing cancer. 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? 

The policy options include a no-policy-change scenario, which serve as a baseline for assessing and 
comparing the policy options described under section 5.2. A timeframe of 40 years is assumed for 
the baseline due to the long latency periods65 for carcinogenic substances. Cancer might indeed take 
a  long  time  to  develop  after  the  exposure  to  a  carcinogenic  substance.  This  means  that  several 
future  cancer  cases  would  occur  independently  of  this  initiative.  Therefore,  the  baseline  does  not 
include cancer cases resulting from past exposure66. 

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

This  section  outlines  the  baseline  scenarios  for  the  four  substances  subject  to  the  initiative.  It 
describes how the problem is expected to evolve over 40 years in case no further action is taken at 
EU  level.  These  baseline  scenarios  are  based  on  the  evidence  gathered67  to  support  this  impact 
assessment  and  take  account  of  the  impact  of  the  implementation  of  limit  values  for  other 
substances, the effects of forthcoming changes in national legislations, the future trends (e.g. in use 
and  recycling  of  the  substances,  in  exposure  concentrations  due  to  technical  improvements  or  in 
exposed  workforce),  and  any  other  relevant  insights  for  the  future  (e.g.  impact  of  the  green 
transition). More detailed information on the relevant sectors, number of enterprises with exposed 
workers,  number  of  workers,  exposure  levels  and  some  methodologic  aspects  (including  trends, 
quantification and monetisation of costs and benefits) is provided in annexes 4 and 6. 

5.1.1.  Cobalt and inorganic cobalt compounds 

113,000  workers  in  the  EU  are  estimated  to  be  currently  exposed  to  cobalt  and  its  inorganic 
compounds.  The main sectors  with  exposed workers are manufacture of tools (26.5% of the total 
exposed  workforce),  machining  (22.1%),  ceramics  (6.6%),  biogas  (4.8%),  surface  treatment  of 
metals (4.6%), vehicles (4.6%) and medical and dental devices (4.4%). 

The  data  and  evidence  gathered68  indicates  that  the  use  of  cobalt  over  the  next  40  years  will  be 
influenced  by  the  green  transition,  in  particular  the  growing  manufacturing  of  batteries,  the 
transition  from  fossil  fuels  to  alternatives  and  the  growing  recycling  and  recovery  of  critical  raw 
materials. The following sectors will particularly be impacted: batteries (+5% increase in the use of 
cobalt every year), petrochemicals (-6%), catalysts (-6%) and metal recovery (+5%). Based on this, 
the exposed workforce for these sectors is assumed to follow the same trends than for the uses over 
40  years,  as  described  in  table  6.  For  the  other  sectors,  although  the  use  and  number  of  exposed 
workers  may  slightly  increase,  this  could  be  counterbalanced  by  further  automatization  in  some 
sectors. In the absence of evidence supporting another scenario, it was assumed that the number of 
workers would remain stable for the other sectors over 40 years.   

65 The latency period is the time between an exposure and the occurrence of disease related to it.  
66  For  this  reason,  the  number  of  actual  cancer  cases  to  occur  in  the  future  as  a  result  of  exposure  to  the  concerned 
substances could be considerably higher than the future disease burden provided in the following sections. 
67 RPA (2024), op. cit. 
68 RPA (2024), op. cit.  

20 

 
 
The current levels of exposure of these workers differ depending on their sectors of activity and the 
RMMs currently in place (see section 2 and annex 6).  The sectors with the highest average levels 
of exposure69 are welding (12.9 µg/m³), medical and dental devices (11.5), production of electronic 
components  (7.6)  and  manufacture  of  other  fabricated  metal  products  (7.4).  Furthermore,  the 
evidence  gathered  from  stakeholders70  indicates  that  the  ongoing  implementation  of  the  EU-wide 
limit  values  for  nickel  compounds,  chromium  VI  compounds  and  cadmium  and  its  inorganic 
compounds  is  expected  to  also  decrease  the  exposure  to  cobalt  and  its  inorganic  compounds  in 
some  sectors71,  due  to  co-exposure.  For  instance,  three  respondents  have  indicated  that  the  limit 
value for nickel compounds may reduce the exposure concentrations for cobalt and inorganic cobalt 
compounds by less than 50%. Indeed, although nickel and cobalt are typically not used together in 
catalysts, the same production lines are used for production. Therefore, it is important to take into 
account  the  effect  of  the  limit  value  for  nickel  compounds  on  workers’  exposure  to  cobalt  when 
assessing costs and benefits. A table summarizing the adjusted concentration for all relevant sectors 
is available in Annex 6.  

The levels of exposure might theoretically decrease over the next 40 years due to possible actions at 
company level in  favour of workers’ protection (e.g.  further use of closed systems), an  increased 
use of automatization in some sectors and forthcoming regulatory changes within Member States. 
However,  in  the  absence  of  any  evidence  to  support  these  assumptions  and  as  agreed  by  the 
employers, workers and government experts steering the work of the supporting study’s contractor, 
a trend of 0% was used for the baseline.  

With these  assumptions,  about  19,000 workers exposed to  cobalt and its  inorganic compounds in 
the EU will become ill over the next 40 years in case of no EU action (76 lung cancer cases, 4,365 
restrictive lung disease cases and 14,152 upper airway irritation cases).  

Table 6: baseline scenario for cobalt and its inorganic compounds over 40 years 

Number of exposed workers 
Change in exposure level 
Change in number of exposed workers 

Future disease burden (FDB) from current and future 
exposure – Number of cases over 40 years 

113,000 
0% 

- +5% for batteries 
-  -6% for petrochemical, catalyst 
-  -6% for catalysts 
-  +5% for metal recovery 
-  0% for the other sectors 

18,593 
-  76 (lung cancer) 
-  4,365 (restrictive lung disease) 
-  14,152 (Upper airway irritation) 

Estimated deaths due to FDB cancer over 40 years 
Monetary value FDB cancer over 40 years 

60 
-  Method 172: €32 million  
-  Method 273: €61 million 

69 Inhalable fraction, with adjustment for the use of respirable protective equipment.  
70 RPA (2024), op. cit.  
71 For nickel compounds: manufacture of other inorganic basic chemicals, catalysts, steel, manufacture of cobalt and 
cobalt alloys, batteries / For chromium VI compounds: welding / For cadmium and its inorganic compounds: batteries 
72 Application of WTP (willingness to pay) values to each case. More information on this methodology is provided in 
annex 4. 

21 

 
 
 
Monetary  value  FDB  other  adverse  health  effects 
over 40 years 

-  Method 1: €98 million  
-  Method 2: €115 million 

Source: RPA (2024) 

5.1.2.  Polycyclic aromatic hydrocarbons - PAHs  

About 1.3 million workers in the EU are currently estimated to be exposed to PAHs across a wide 
range of sectors, as detailed in annex 6. More than 90% of exposed workers are active in one of the 
following  five  sectors:  firefighters74  (both  professionals  and  volunteers  –  34.2%),  motor  vehicle 
maintenance and repairs (28.9%), road paving (16.6%), steel and iron foundries, ferroalloys (7.5%), 
and casting of metals (5.3%).  

According to the evidence gathered75, some sectors should be impacted by a number of long-term 
driving forces, in particular, climate change and other environmental factors, aggravating resource 
scarcity  and  the  acceleration  of  technical  change.  As  a  result,  it  is  assumed  that  the  exposed 
workforce will vary annually over time for the following four sectors:  

• 

refineries (-6%/year): refinery capacity is expected to decrease  by 6% per year, due to the 
transition  to  electric  vehicles  in  the  automative  sector  as  well  as  alternative  fuels  in  the 
maritime and aviation sectors resulting in less demand for petroleum products;  

•  aluminium  manufacturing  (+1%):  demand  for  aluminium  is  expected  to  increase  with  the 
green  transition  (e.g.  aluminium  is  used  for  electric  vehicles  for  reducing  weight  and  in 
batteries,  electricity  networks  and  solar  panels).  According  to  a  study  conducted  by 
Eurometaux76, the demand for aluminium will increase between 0.6-1.4% per year;  

•  silicon  metal  manufacture  (+1.95%):  the  shift  towards  renewable  energy  is  expected  to 
result  in  an  increase  in  demand  for  silicon  metal,  which  is  key  among  others  for 
photovoltaic  panels,  batteries  and  semi-conductors.  Eurometaux77  estimates  that  silicon 
metal demand will increase by between 1.6-2.3%; and  

•  coal fired power plants (-2.5%): the climate-neutrality objective of the EU is the main driver 
behind coal power plant closures. According to the European Commission’s Joint Research 
Center (‘JRC’), up to 100% of existing coal power plants will be decommissioned by 2030. 
However,  coal  power  plants  have  experienced  a  recent  resurgence  due  to  the  current 
geopolitical climate. Based on this, an annual decrease of 2.5% in the number of workers is 
expected. 

However, and despite the above estimated impacts on exposed workers, these sectors represent less 
than 4% of the total exposed workforce and it is therefore assumed that their evolution should not 
influence future trends in terms of the number of workers exposed.  

73  Use  of  DALYs  (disability  adjusted  life  year)  and  their  monetisation.  More  information  on  this  methodology  is 
provided in annex 4. 
74  438,506  firefighters  are  assumed  to  be  exposed  to  PAHs  in  the  air.  If  we  had  the  firefighters  which  are  at  risk  of 
dermal exposure, this brings the total number of exposed firefighters to 4,385,060 (365,000 professionals and 4,020,060 
volunteers).  
75 RPA (2024), op. cit.  
76 KU Leuven (2022), Metals for Clean Energy:  Pathways to solving Europe’s raw materials challenge. Available at: 
metals-for-clean-energy.pdf (eurometaux.eu) 
77 KU Leuven (2022); op. cit.  

22 

 
 
   
 
Another  factor  that  could  impact  the  number  of  exposed  workers  over  time  is  the  increased 
automatization  in  some  sectors.  Nevertheless,  no  robust  data  to  support  the  impact  of 
automatization was identified. It is therefore assumed that the overall number of exposed workers 
will keep stable. 

On the other hand, the exposure levels to PAHs are expected to decrease annually by 1.2% over the 
next 40 years. The current average levels of exposure to PAHs differ depending on their sectors of 
activity and the current RMMs currently in place (see section 2 and annex 6).  The sectors with the 
highest  average  levels  of  exposure78  are  welding  of  train  tracks  (300-400  ng/m³),  coking  plants 
(329),  manufacture  of  refractory  products  (207),  coal  tar  distillation  (152)  and  other  non-ferrous 
metallurgical  processes  (152).  According  to  the  evidence  gathered79,  the  implementation  of  other 
limit values, including from previous revisions of the CMRD, is not expected to lead to significant 
impact on PAHs exposure.  

A trend of -1.2% per year for the benzo[a]pyrene80 (BaP) exposure concentration between 1975 and 
2009  was  reported81,  due  to  several  factors,  including  changes  in  the  production  methods  or 
application (e.g. banning of the use of coal tar for paving, automation of oven operations in coking 
plants) or development in the engines releasing less PAHs. Furthermore, the evidence gathered has 
not  identified  any  forthcoming  changes  in  national  limit  values  or  protective  regulation  and  self-
regulatory  initiatives.  Although  some  possible  upcoming  PAHs-related  REACH  restrictions  were 
identified  (more  details  are  available  in  annex  11),  it  is  not  possible  to  anticipate  how  they  may 
affect the baseline. In this context, and in the absence of any evidence questioning the continuous 
past trend for concentration exposures, it was decided to set the same trend for the future (-1.2%).   

With  regard  to  the  FDB,  3,355  workers  are  expected  to  get  ill  over  the  next  40  years  due  to  the 
exposure  to  PAHs  (184  lung  cancer  cases,  38  developmental  toxicity  case  and  3,157  infertility 
cases). Among them, 128 workers are expected to die from cancer.   

Table 7: baseline scenario for PAHs over 40 years 

Number of exposed workers 
Change in exposure level 
Change in number of exposed workers 
Future disease burden (FDB) from current and future 
exposure – Number of cases over 40 years 

Estimated deaths due to FDB cancer over 40 years 
Monetary value FDB cancer over 40 years 

Monetary  value  FDB  other  adverse  health  effects 
over 40 years 
Source: RPA (2024) 

1,284,052 
1.2% overall 
0% 
3,355 
-  160 (lung cancer) 
-  38 (developmental toxicity) 
-  3,157 (infertility) 
128 
-  Method 1: €130 million 
-  Method 2: €67 million 
-  Method 1: €72.7 million 
-  Method 2: €5.3 million 

78 With adjustment for the use of respirable protective equipment.  
79 RPA (2024) op. cit., stakeholders consultation 
80 In its opinion, RAC concluded that benzo[a]pyrene is the most robust marker of overall PAHs exposure. 
81 Peters, S., Vermeulen, R., L., P., A., O., B., K., Vincent, R., et al.  (2016). SYN-JEM: A Quantitative Job-Exposure 
Matrix for Five Lung Carcinogens. Ann. Occup. Hyg., 60(7), 795-811. 

23 

 
 
 
5.1.3.  1,4-dioxane 

Around  30,000  workers  are  currently  exposed  to  1,4-dioxane  in  the  EU.  Almost  90%  of  these 
workers  are  active  in  three  sectors:  pharmaceutical  production  (48%),  laboratories  (24%)  and 
industrial use as solvent and generation as by-product in the chemical sector (17.5%). 

As a result of the recent reclassification of 1,4-dioxane as carcinogenic 1b82 in the CLP Regulation 
and  its  inclusion  in  the  list  of  SVHC83,  which  are  subject  to  potential  regulatory  attention  under 
REACH,  we  could  expect  that  the  past  trend  of  -2%84  related  to  the  number  of  exposed  workers 
continues. However, the evidence gathered85 also shows that certain sectors manufacturing or using 
1,4-dioxane  have  seen  an  increase  in  their  number  of  companies  between  2011  and  2020  of 
approximatively  2%  per  year  in  total.  Therefore,  it  is  assumed  that  both  trends  will  cancel  each 
other out, resulting in no change in the number of workers exposed during the next 40 years. No 
forthcoming  changes  in  national  limit  values  or  other  relevant  national  legislation  have  been 
identified.  

According  to  the  evidence  gathered,  including  the  RMMs  currently  in  place  (see  section  2  and 
annex 6), the highest average exposure is observed in the chemical sector (10.5 mg/m3) where 1,4-
dioxane  is  industrially  used  as  a  solvent  and  generated  as  by-product.  Workers  operating  in  the 
other  sectors  are  exposed  on  average  to  a  level  lower  than  3.9  mg/m3.  In  the  absence  of  data, 
including on technical improvements that could result in decreasing workers’ exposure, no past and 
future trends  could  be identified.  It is  also  not expected that  any of the EU-wide limit  values for 
other  substances  that  have  already  been  adopted  but  are  not  yet  in  force  are  likely  to  have  a 
significant  impact  on  occupational  exposure  to  1,4-dioxane.  It  was  therefore  assumed  that  the 
exposure concentrations would remain stable over 40 years (conservative approach).  

In  case  of  no  EU  action,  and  based  on  the  assumptions  described  above,  5,512  workers  would 
suffer from non-carcinogenic diseases over the reference period (497 with kidney effects, 633 with 
liver effects and 4.382 from local irritation).    

Table 8: baseline scenario for 1,4-dioxane over 40 years 

Number of exposed workers 
Change in exposure level 
Change in number of exposed workers 
Future disease burden (FDB) from current and future 
exposure – Number of cases over 40 years 

Estimated deaths due to FDB cancer over 40 years 
Monetary value FDB cancer over 40 years 
Monetary  value  FDB  other  adverse  health  effects 
over 40 years 
Source: RPA (2024) 

31,150 
0% 
0% 
5,512 
-  497 (kidney effects) 
-  633 (liver effects) 
-  4,382 (local irritation) 
0 
€0 
-  Method 1: €4.9 million 
-  Method 2: €6.5 million  

82  Category  1b  carcinogen:  presumed  to  have  carcinogenic  potential  for  humans,  classification  is  largely  based  on 
animal evidence. 
83  
84 This past trend of -2% in the number of exposed workers was assumed based on CAREX Canada reporting an 18% 
decrease in workers exposed to 1,4-dioxane between 2006 and 2016, suggesting an annual decrease of 2%.  
85 RPA (2024), op. cit., sections 3.10 and 4.7 of the 1,4-dioxane report.  

24 

 
 
5.1.4.  Welding fumes 

Around  1.2  million  workers  are  estimated  to  be  currently  exposed  to  welding  fumes86.  They  are 
active in a wide range of sectors as described in annex 6. Based on Eurostat data, three quarters are 
operating  in  the  following  four  sectors:  specialised  construction  activities  (36%),  construction  of 
buildings  (19%),  manufacture  of  fabricated  metal  products  (12%),  and  wholesale  and  retail  trade 
and repair of motor vehicles and motorcycles (10%).  

A  limit  value    for  most  of  the  metals  and  metal  compounds  classified  as  carcinogenic  have  been 
already  set  in  the  Annex  III  of  the  CMRD.  Some  of  them  (for  chromium  (VI)  compounds  and 
nickel  compounds)  have  a  transitional  period  until  end  of  January  2025.  These  two  groups  of 
compounds are of particular concern as carcinogens in welding fumes from welding stainless steel 
(food  industry,  medical  industry,  petrochemical  and  power/heating  plants).  They  can  also  be 
contained  in  welding  fumes  released  when  welding  mild  steel,  although  in  less  quantity. 
Theoretically, the introduction of limit values for cobalt and PAHs can also be beneficial, although 
to a much lesser extent. However, due to the paucity of data for welding fumes exposure in general, 
it was not possible to take account of the potential impact of implementation of other limit values in 
the calculation of the baseline.    

The evidence gathered indicates87 that the annual EU welding market growth forecast is 4.5%. This 
increased  demand  is  partly  attributed  to  the  EU  green  transition,  which  requires  investments  in 
energy  infrastructure  (e.g.  power  networks,  electric  vehicle  charging  infrastructure  and  wind 
turbines).  Other  megatrends  such  as  the  continuing  urbanisation,  growing  consumerism  are  also 
expected  to  support  this  growing  demand.  With  the  ongoing  investment  in  robotics88  and  the 
current shortage of welders, it is expected that most of this growth is to be carried out by new and 
automated  technologies.  In  the  absence  of  robust  data,  it  was  assumed  that  this  welding  market 
growth  forecast  will  lead  to  a  growth  of  0.45%  in  the  number  of  welders  per  year  (10%  of  the 
growth forecast). This assumption is supported by the current skills shortage of trained welders in 
Europe which encourages businesses to invest in automated technologies.  

The evidence gathered89 indicates that the past exposure levels to welding fumes declined between 
2% and 4% per year. The increasing automation of welding processes will lead to further reduction 
in  exposure  to  welding  fumes,  in  particular,  in  the  automotive  sector.  However,  this  decrease 
depends  on  the  current  RMMs  in  place.  According  to  the  evidence  gathered90,  it  is  assumed  that 
many businesses, in particular larger enterprises, are already applying best practices measures. 

The  evidence  gathered  suggests  that  EU  Western  Member  States  are  more  advanced  in  the 
implementation  of  RMMs  and  adoption  of  innovative  processes  than  other  Member  States. 
According  to  some  stakeholders91,  the  best  practice  is  already  applied  and  additional  RMMs  will 
not  reduce  worker  exposure  any  further.  Therefore,  countries  (or  enterprises)  with  lower  current 

86 RPA (2024), op. cit.  
87 RPA (2024), op. cit. 
88 RPA (2024), op. cit., data provided by the European Welding Association.  
89  RPA  (2024),  op.  cit.,  the  paucity  of  exposure  data  does  not  allow  for  a  comparison  of  exposure  levels  from  a 
particular welding process undertaken in a particular sector.  
90 RPA (2024), op. cit. 
91  German  Welding  Society  (DVS  –  Deutscher  Verband  für  Schweißen  und  verwandte  Verfahren)  and  German 
automative manufacturers. 

25 

 
 
 
workers  protection  from  exposure  to  welding  fumes  have  more  to  gain  in  RMMs.  Furthermore, 
innovative  practices  to  optimise  welding  process  could  also  lead  to  reductions  in  exposure  to 
welding fumes. In the absence of further data and given the above information, it was assumed that 
the exposure levels will continue declining but at a lower pace (1% per year) as best practices may 
already be implemented in some countries such as Germany and the Netherlands. 

In  the  absence  of  robust  data  on  non-cancer  endpoints,  the  FDB  is  limited  to  lung  cancer  cases. 
Considering the future trends summarised in table 9, around 28,000 workers would get lung cancer 
over  the  next  40  years.  This  FDB  are  likely  to  be  underestimated  since  the  exposure  of  workers 
being in the vicinity of welding processes were not considered, due to insufficient data. As a result 
of their exposure to welding fumes, about 23,000 workers would lose their lives.     

Table 9: baseline scenario for welding fumes over 40 years 

Number of exposed workers 
Change in exposure level 
Change in number of exposed workers 
Future  disease  burden  (FDB)  –  Number  of  cases 
over 40 years 
Estimated deaths due to FDB cancer over 40 years 
Monetary value FDB cancer over 40 years 

Monetary  value  FDB  other  adverse  health  effects 
over 40 years 
Source: RPA (2024) 

1,200,000 
-1% 
+0.45%/year 
28,821 (lung cancer) 

23,057 
-  Method 1: €11.8 billion 
-  Method 2: €22.6 billion 
Cannot be estimated due to insufficient data 

5.2.  Description of the policy options 

5.2.1.  Structure and logic of the policy options 

To meet the first three objectives outlined in the table below, limit values should be established for 
cobalt and inorganic cobalt compounds, PAHs and 1,4-dioxane. For each substance subject to the 
setting of limit values, several policy options for limit values are identified to further improve the 
existing  regulatory  framework  and  further  levelling  the  playing  field  at  EU  level.  These  policy 
options always include the limit values derived by RAC (scientific experts), where any, and those 
recommended by the tripartite ACSH (stakeholders). These limit values are key as they represent 
either the limit  values below which workers’ exposure is  not  dangerous  (health-based limit  value 
derived by RAC) or the most proportionate limit values according to social partners and Member 
States  authorities  represented  in  the  WPC/ACSH  as  they  ensure  values  which  are  protective  for 
workers  and  technically  and  socio-economically  feasible  for  businesses.  There  are  no  existing 
health-based limit values for some substances (PAHs). In this case, RAC provides an exposure-risk 
relationship,  which  provides  the  correspondence  between  the  substance  concentration  and  the 
statistical probability of developing cancer (additional risk beyond the background incidence).  

In addition, other relevant reference points are chosen as policy options to ensure a wide range of 
levels for assessment. These additional policy options were mainly based on the new methodology 

26 

 
 
establishing risk-based limit values for non-threshold carcinogens92 and the existing national limit 
values. According to this new methodology, limit values for non-threshold carcinogens as set out in 
the  ACSH  opinion  should  be  set  between  the  upper  risk  level  of  4:1,000  (corresponding  to  4 
predicted cancer cases in 1,000 employees) and the lower risk level of 4:100,000. The next section 
provides more detailed information regarding the reasons for choosing each option. All these policy 
options are summarized in table 10 and further discussed in annex 9. 

For each policy option, the employers would need to put in place the necessary additional RMMs to 
keep workers’ exposure below the limit value(s). As a result, workers would be less exposed to the 
below hazardous substances, which should further improve OSH at EU level.  

In addition to the policy options for OELs and BLVs, RAC also recommended the setting of short-
term exposure limit (STEL) for 1,4-dioxane, and notations for cobalt and its inorganic compounds, 
PAHs  and  1,4-dioxane.  These  accompanying  measures  are  not  expected  to  result  in  significant 
costs and are therefore not assessed individually. More information on these measures is provided 
in annex 10.  

An  inclusion  of  welding  fumes  in  Annex  I  of  the  CMRD  has  been  identified  by  relevant 
stakeholders represented in the ACSH as a means to meet the fourth specific objective outlined in 
the  table  below.  Furthermore,  the  existing  Senior  Labour  Inspectors  Committee’s93  (SLIC) 
Guidance for National Labour Inspectors on addressing health risks from Welding Fume94 could be 
updated  in  the  coming  years,  which  would  contribute  to  improving  awareness  of  the  possible 
dangerousness of welding fumes. However, in  the absence of  specific  information on if  and how 
this  guidance  document  will  be  updated,  the  effects  of  this  option  could  not  be  assessed.  More 
information on this possible revision is available in annex 10, under the accompanying measures. 

92 DG EMPL (2023), Methodology establishing risk-based limit values for non-threshold carcinogens, for the purposes 
of Article 1 (18a) of Directive 2004/37/EC, available at: 
https://ec.europa.eu/social/BlobServlet?docId=27151&langId=en  
93 The SLIC has the mandate to give its opinion on all matters relating to the enforcement by the Member States of EU 
legislation on health and safety at work. It consists of representatives of the labour inspection services of the Member 
States,  as  mentioned  in  the  Commission  Decision  of  July  1995  setting  up  a  Committee  of  Senior  Labour  Inspectors 
(95/319/EC).  The  Committee  shall  comprise  on  full  member  per  Member  State  and  one  alternate  member  may  be 
appointed for each full member.  
94 SLIC (2018), Guidance for National Labour Inspectors on addressing health risks from Welding Fume. Available at: 
https://circabc.europa.eu/ui/group/fea534f4-2590-4490-bca6-504782b47c79/library/2997b89a-1fbd-4f35-9874-
9a9b5ea1a403?p=1&n=-1&sort=name_ASC  

27 

 
 
Figure 4: Intervention logic 

5.2.2.  Substances prioritised for the setting of limit values 

This  section  outlines  the  reasons  for  choosing  the  different  options  for  each  substance,  except 
option 1 which corresponds to the baseline scenario for all substances.  

(a)  Cobalt and its inorganic compounds  

Option 2 are the limit values (both inhalable and respirable fraction) recommended by RAC, below 
which workers are assumed to be safe. Options 4 and 5 correspond to the final limit values and the 
transitional  limit  values  recommended  by  the  ACSH,  respectively.  Option  3  is  an  intermediate 
limit values between option 2 and option 4 to avoid a significant gap between two values. Finally, 
option 6 corresponds to the combination of limit values (final and transitional), as recommended by 
the  ACSH  in  its  opinion95.  This  transitional limit value  of  6  years  at  the  level  of  option  5  would 
apply to all sectors, giving more time to businesses to plan their investments.  

(b) PAHs 

Options  2  and  4  correspond  to  the  limit  value  with  an  associated  risk  of  4:100,000  and  4:1,000 
according to RAC opinion96. Option 3 is the final limit value recommended by the ACSH. Option 
5  corresponds  to  the  combination  of  limit  values  (final  and  transitional),  as  recommended  by  the 
ACSH  in  its  opinion97.  This  recommended  transitional  value  of  140  ng/m³  (double  the  preferred 
option) would apply during 6 years and would be limited to 9 sectors: (1) steel and iron foundries, 
which  includes  ferroalloy  manufacturers,  (2)  aluminium  manufacturers,  (3)  carbon  and  graphite 
electrode  manufacturers,  (4)  coking  plants,  (5)  coal  tar  distillation,  (6)  refractory  products 
manufacturers,  (7)  welding  of  train  tracks,  (8)  other  non-ferrous  metallurgical  processes,  and  (9) 

95  ACSH  (2023),  Opinion  on  an  EU  BOEL  and  notations  for  cobalt  and  its  inorganic  compounds,  Doc.  005/23, 
available at: ACSH Adopted opinion Cobalt and inorganic compounds 22.09.23-EN.pdf (europa.eu) 
96 RAC (2022), Opinion on scientific evaluation of occupational exposure limits for polycyclic aromatic hydrocarbons, 
available at: 06454dd9-cadc-acef-a11b-439f2a0d8efa (europa.eu) 
97  ACSH  (2023),  Opinion  on  an  EU  BOEL  for  polycyclic  aromatic  hydrocarbons,  Doc.  003/23,  available  at:  ACSH 
Adopted opinion PAHs 22.09.23-EN.pdf (europa.eu) & Addendum to ACSH opinion 003/23, available at: Addendum 
to ACSH opinion PAHs-EN.pdf (europa.eu) 

28 

 
 
 
casting of metals. According to the ACSH, these 9 specific sectors are expected to face high costs 
and/or are at risk of discontinuation. 

(c)  1,4-dioxane  

Option 2 corresponds to the health-based limit value derived by RAC  in its opinion98 and is also 
the limit value recommended by the ACSH99. As both RAC and the ACSH recommended the same 
limit  value,  only  one  additional  option  (option  3)  was  considered  and  corresponds  to  the  lowest 
existing national limit value (LV and NL). 

According to RAC, occupational exposure is expected to occur via inhalation and dermal route. As 
an OEL only protects workers from oral exposure, it is also important in this case to set a BLV. In 
its  opinion,  RAC  identified  2-hydroxyethoxyactic  acid  (HEAA)  as  the  main  metabolite.  It  also 
established a relationship between the mean urinary HEAA levels after the end of exposure and the 
air concentration of 1,4-dioxane. This function is urinary HEAA level (in mg/g creatinine) at end of 
exposure = 17.82 x (air concentration of 1,4-dioxane in ppm) + 9.52. This function is used in this 
impact assessment to calculate BLVs corresponding to each OEL option. 

Table 10: policy options for each substance subject to the setting of limit values 

Option 2 

Option 3 

Option 4 

Option 5 

Option 6 

Hazardous 
substance 
Cobalt  and  its 
inorganic 
compounds 

OEL 
1100 / 0.5101 
µg/m³ 
(RAC values) 

OEL 
5 / 1.25 µg/m³ 
(Intermediate 
values102) 

OEL 
10 / 2.5 µg/m³ 
(ACSH final 
values) 

OEL 
20 / 4.2 µg/m³ 
(ACSH 
transitional 
values) 

PAHs104 

OEL 
7 ng/m³ 
(Excess risk of 
4:100,000) 

OEL 
70 ng/m³ 
(ACSH final 
value) 

OEL 
700 ng/m³ 
(Excess risk of 
4:1,000) 

OEL 
70 ng/m³, with 
transitional 
limit value of 
140 ng/m³ for 
some sectors105 

98  RAC  (2022),  Opinion  on  scientific  evaluation  of  occupational  exposure  limits  for  1,4-dioxane,  available  at: 
686365df-9485-c2ac-b342-289ec306d188 (europa.eu) 
99 ACSH (2023), Opinion on an EU BOEL, STEL, BLV and skin notation for 1,4-dioxane, Doc. 007/23, available at: 
ACSH Adopted opinion 1_4-dioxane 22.09.23-EN.pdf (europa.eu) 
100 Inhalable fraction, which is defined as the mass fraction of particles which can be inhaled by nose or mouth.  
101 Respirable fraction, which is defined as the mass fraction of particles that reaches the alveoli.   
102  Policy  option  3  for  cobalt  is  a  pair  of  intermediate  values  between  those  recommended  by  RAC  and  the  ACSH, 
given the relative gap between policy options 2 and 4.  
103 Until 6 years after entry into force of the Directive 
104 OEL options are measured as benzo[a]pyrene, which is considered as a marker substance for carcinogenic PAHs by 
RAC in its scientific opinion.  
105  Until  6  years  after  entry  into  force  of  the  Directive  for  the  following  sectors:  (1)  steel  and  iron  foundries,  which 
includes ferroalloy manufacturers, (2) aluminium manufacturers, (3) carbon and graphite electrode manufacturers, (4) 
coking plants, (5) coal tar distillation, (6) refractory products manufacturers, (7) welding of train tracks, (8) other non-
ferrous metallurgical processes, and (9) casting of metals. 

29 

OEL 
10 / 2.5 µg/m³, 
with 
transitional 
limit values of 
20 / 4.2 
µg/m³103  
(ACSH 
combination of 
values) 

- 

 
 
 
 
 
(ACSH 
combination of 
values) 

- 

- 

- 

1,4-dioxane 

OEL 
7.3 mg/m³ (2 
ppm) 
(RAC & ACSH 
value) 

OEL 
20 mg/m³ (5.5 
ppm) 
(lowest 
national value) 

BLV 
45 mg HEAA 
in urine/g 
Creatinine  
(RAC & ACSH 
value / 
corresponding 
value106 to OEL 
option 2) 

BLV 
108 mg HEAA 
in urine/g 
Creatinine 
(corresponding 
value to OEL 
option 3) 

5.2.3.  Welding fumes - substance subject to inclusion in the scope of the CMRD 

The  evidence  gathered  indicates  that  some  employers  are  not  aware  that  their  welding  processes 
may contain carcinogens, mutagens or reprotoxic substances. This driver was also supported by the 
tripartite ACSH in its opinion107. These employers may therefore ignore to what extent exposure to 
welding  fumes  is  dangerous  for  their  workers  and  include  substances  that  are  carcinogenic, 
mutagenic or reprotoxicant. Consequently, and despite the fact that welding can be a relatively safe 
activity if all the safety and exposure control measures are in place, it remains a prominent concern 
that welders are at high risk from various diseases, including cancers108.  

According to ECHA109 in its scoping study on welding fumes, an entry of welding fumes in Annex 
I of the CMRD would bring clarity about employers’ duties and which measures have to be taken. 
The introduction of welding fumes in Annex I to the CMRD would ensure a better implementation 
of  the  existing  obligations  laid  down  in  the  CMRD.  This  introduction  aims  to  draw  employers’ 
attention  to  the  possible  dangerousness  of  the  fumes  generated  by  their  welding  process.  As 
provided  by  the  CMRD,  employers  have  to  perform  a  risk  assessment  as  soon  as  an  activity  is 
likely to involve a risk of exposure to carcinogens, mutagens or reprotoxic substances. The ECHA 
scoping study will support this assessment as it provides information on welding processes likely to 
generate carcinogens, mutagens or reprotoxic substances. If this risk assessment reveals that their 
welding  fumes  contain  such  hazardous  substances,  employers  will  need  to  take  all  the  necessary 
RMMs to comply with the obligations laid down in the CMRD, including the hierarchy of controls 
in  Articles  4  and  5.  The  introduction  of  welding  fumes  does  not  result  in  new  rules  but  aims  to 

106 RAC provides a relationship between the  mean urinary HEAA levels after the end of exposure (extrapolated to 8 
hours)  and  the  air  concentration  of  1,4-dioxane.  Based  on  this  correlation,  the  following  policy  options  for  BLVs 
corresponding to the retained options for OELs were set: 45 mg, 108 mg and 188 mg.  
107  ACSH  (2023),  Opinion  on  introducing  work  involving  exposure  to  fumes  from  welding  processes  containing 
substances  that  meet  the  criteria  for  CMR  category  1A/1B  set  out  in  Annex  I  to  the  CLP  Regulation,  Doc.  006/23, 
available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu) 
108  ECHA  (2022),  Scoping  Study  report  for  evaluation  of  limit  values  for  welding  fumes  and  fumes  from  other 
processes that generate fume in a similar way at the workplace, available at: report_welding_fumes_en.pdf (europa.eu) 
109 ECHA (2022), op. cit. 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ensure a correct implementation of the existing ones, which contributes to the proportionality of the 
proposal. 

The policy option of an entry of welding fumes in Annex I was supported in its opinion110 by the 
ACSH.  The  three  interest  groups  consider  that  an  inclusion  into  Annex  I  might  indicate  to 
stakeholders that more needs to be done to ensure that the RMMs are in place and will bring clarity 
about employer’s duties on measures to be taken.  

Given the broad support from the three interest groups within the ACSH, the inclusion of welding 
fumes in Annex I was kept as policy option.   

No  additional  policy  option  other  than  the  inclusion  in  Annex  I  and  the  complementary  measure 
related the possible revision of the SLIC guidance was retained for welding fumes. Indeed, in the 
absence of scientific opinion from RAC on the possible setting of a limit value for welding fumes, 
the  latter  could  not  be  considered  as  an  option  for  the  current  initiative.  Furthermore,  the 
heterogeneous character of welding fumes makes it very difficult to establish a common OEL for 
all welding processes.   

Furthermore,  several  guidance  documents  already  exist  at  EU-level,  including  the  Senior  Labour 
Inspectorate  Committee’s  guidance  on  addressing  health  risks  from  welding  fumes111  and  the 
European  Welding  Association’s  (EWA)  guidance112.  Despite  the  existence  of  guidance  at  EU 
level, the evidence gathered shows that the welding fumes-related problem persists. Therefore, the 
development  of  new  guidance  was  not  considered  relevant  to  address  the  problem.  More 
information on both guidances is available in annex 10. 

5.2.4.  Isoprene-related discarded options  

The  evidence  gathered113  indicates  that  the  exposure  of  workers  to  isoprene  is  lower  than  the 
threshold  limit  value  derived  by  RAC.  Therefore,  no  problem  was  identified  for  isoprene,  as 
described  in  section  2.  Consequently,  no  policy  option  was  assessed  in  the  main  report  of  this 
impact  assessment.  However,  as  the  ACSH  recommended  a  limit  value  for  isoprene,  and  for  the 
sake  of  transparency,  a  fully-fledged  analysis  of  this  option  was  carried  out  and  is  available  in 
annex 10.  

5.2.5.  Options discarded at an early stage 

A number of policy options that have been considered at the early stages of this initiative have been 
discarded  without  a  detailed  assessment  of  their  impacts,  either  because  they  are  clearly 
disproportionate (banning the use of substances, directly adopting the most stringent national limit 
values, less stringent rules for SMEs resulting in less ability to attract workers as the latter would 
favour  better  working  conditions),  or  unsuitable  to  achieve  the  policy  objectives  (providing 
industry-specific  scientific  information  without  amending  the  CMRD,  guidance  documents 

110 ACSH (2023), op. cit. 
111 SLIC (2018), Guidance for National Labour Inspectors on addressing health risks from Welding Fume. Available at: 
https://circabc.europa.eu/ui/group/fea534f4-2590-4490-bca6-504782b47c79/library/2997b89a-1fbd-4f35-9874-
9a9b5ea1a403?p=1&n=-1&sort=name_ASC 
112 EWA (2021), Welding Exposure Scenario – ENGL. Available at : WES-EWA-TCC-458-2021-05-English-002.pdf 
113 RPA (2024), op. cit. 

31 

 
 
(including  to  address  the  lack  of  awareness  related  to  welding  fumes)),  or  there  is  insufficient 
scientific information (setting a limit value for welding fumes). Annex 10 contains a description of 
those policy options and the reasons for discarding them.   

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? 

Section  6  outlines  for  each  substance  the  identified  relevant  positive  and  negative  impacts 
associated  with  the  selected  policy  options  against  the  baseline.  Overview  tables  per  substance 
summarising  all  impacts  are  available  in  Annex  4.  The  impacts  are  classified  in  three  main 
categories: economic, social and environmental. They mainly concern three groups of stakeholders: 
workers (and their families), businesses and public authorities. These impacts are mostly monetised 
or quantified on a 40-year reference period, to calculate the total risk over the working life. When 
the available data  does  not  allow for this, impacts  are discussed qualitatively.  Data  collection  for 
the purpose of this impact assessment includes literature review (including scientific literature) and 
stakeholder  consultation  (targeted  questionnaires,  interviews,  site  visits  and  conversations).  More 
information on stakeholder consultation is available in annex 2.   

The  introduction  of  limit  values  for  cobalt  and  its  inorganic  compounds,  PAHs  and  1,4-dioxane, 
and inclusion of welding fumes in Annex 1 of the CMRD, is expected to reduce the occupational 
exposure to these hazardous substances as businesses with exposure levels higher than the options 
will have to invest in additional RMMs. The extent of such reduction depends on the current levels 
of  exposure  and  RMMs,  as  well  as  the  projected  future  levels  of  exposure  in  the  absence  of  any 
action (‘baseline scenario’). Annex 6 outlines the current RMMs in place by sector, as well as the 
required additional RMMs by sector for each option.  

For  a  given  reduction  in  exposure  levels  of  all  substances  except  welding  fumes,  the  expected 
decrease in  the incidence of ill-health over 40 years was calculated. This involved estimating  the 
risks  of  adverse  health  effects,  derived  from  the  existing  toxicological  and  epidemiological 
literature, and information about the current level of worker exposure (number of workers exposed, 
level,  duration  and  frequency  of  exposure).  The  health  benefits  of  the  new  limit  values  are 
calculated  in  terms  of  the  costs  of  ill-health  avoided.  They  are  expressed  in  monetary  terms  by 
applying standard valuation methods114. 

The estimate of the costs for all substances except welding fumes was based on a literature research 
and  data  obtained  from  stakeholders  and  considers  the  following  factors:  the  RMMs  needed  to 
comply with the proposed limit values, the costs of these RMMs for each company, the life span of 
the RMMs, and the number and size of companies.  

While  acknowledging  the  importance  of  occupational  health  and  safety,  the  employers 
organisations’ feedback during social partners consultation focused on the feasibility and economic 
implications  of  new  regulations,  stressing  the  need  for  transitional  periods,  where  necessary,  and 
careful  socio-economic  impact  analysis  to  avoid  harming  competitiveness.  Additional  details  on 
social partners consultation are available in Annex 2 

114  Method  1  is  the  application of  a  single  willingness  to  pay  (WTP)  value  to  each  case  and  Method  2  is  the  use  of 
disability  adjusted  life  years  (DALYs)  and  their  monetisation.  Both  estimates  monetise  the  same  number  of  avoided 
cases and use identical methods for the monetisation of direct (healthcare, informal care, disruption for employers) and 
indirect (productivity/lost earnings) impacts but use different approaches to assign monetary values to intangible effects 
(reduced quality of life, pain and suffering, etc.). 

32 

 
 
Some policy options for cobalt and its inorganic compounds and PAHs include a transitional value 
(combination  of  two  different  values).  Transitional  values  are  expected  to  reduce  the  adjustment 
costs  and  to  make  the  financing  of  adjustment  costs  cheaper.  Indeed,  the  longer  time  companies 
have to implement compliance measures, the lower are the likely costs. They can for instance better 
plan investments. As further described in annex 4, the total discounted value for adjustment costs 
would  be  16%  lower.  Furthermore,  transitional  values  are  also  expected  to  spread  the  substantial 
one-off  investments  over  a  number  of  years.  Therefore,  companies  could  already  start  planning 
their investments.  

The methodology  to  calculate the  costs and benefits  of placing  welding fumes  in  Annex 1 of the 
CMRD is different from the methodology applied for the substances subject to the setting of limit 
values. The costs and benefits presented below relate to  those additional companies which would 
apply  the  already  required  RMMs  following  the  increased  awareness  of  the  dangerousness  of 
welding fumes induced by their inclusion in Annex 1. In particular, it was assumed that for 1% of 
welders will improve their current RMMs following the introduction of welding fumes in Annex I 
to  the  CMRD.To  validate  these  assumptions,  interviews  were  held  with  key  stakeholders 
representing a large number of welders in the EU, who agreed that the estimates were reasonable.  

Regarding  benefits,  in  the  absence  of  Exposure-Risk  Relationship  and  exposure  data  for  welding 
fumes,  a  tentative  extra  cancer  risk  of  2.7%  was  derived  from  existing  toxicological  and 
epidemiological  literature.  This  excess  risk  is  subject  to  an  average  trend  of  reducing  by  1%  per 
year115,  and  this  was  assumed  to  continue  for  the  next  40  years  for  the  baseline.  The  impact  of 
policy option 2 is assumed to reduce the excess risk by a further 1% for the first five years after the 
policy option takes effect116, due to those companies which would carry out risk assessments and 
apply adequate RMMs following the increase of awareness of the possible presence of carcinogens, 
mutagens or reprotoxicants in welding fumes.  

With regard to costs, two approaches117 are applied:  

•  Bottom-up: this is based on the number of welders that are estimated to move from having 
poor or no RMMs to adequate RMMs as a result of policy option 2 and multiplying this by 
the estimated additional average cost of these RMMs118; and 

•  Top down: based upon the current market value of RMMs being used annually, an estimate 
of an assumed 1% increase in the sale of RMMs as a result of policy option 2 was applied.  

More information on the overall methodology, including the key assumptions, is available in annex 
4. 

Due to the lack of data, the analysis of the impact on workers’ health is limited to the most relevant 
diseases.  For  instance,  exposure  to  PAHs  can  also  result  in  skin  cancer.  However,  the  paucity  of 
data  does  not  allow  for  a  quantification  or  monetisation  of  the  impact  on  health.  Due  to  this 
limitation, the benefits of the options are likely to be underestimated.  

115  RPA  (2024),  op.  cit.  This  trend  was  validated  by  interviews  with  key  stakeholders  where  they  were  specifically 
asked their opinion on the future trend for excess risk.  
116 In other words, a 2% reduction for five years, returning to a 1% reduction from year six.  
117 RPA (2024), op. cit. 
118  In  addition,  only  a  proportion  of  the  workers  that  are  estimated  to  move  to  better  RMMs  will  need  to  buy  new 
RMMS;  some  will  simply  utilise  the  RMMs  that  they  already  have,  which  will  not  incur  additional  costs.  This 
proportion is assumed to be 50% and together it enables a cost for these additional RMMs to be estimated. 

33 

 
 
Furthermore,  the  discontinuation  costs  presented  below  are  subject  to  uncertainty119.  First,  the 
number of companies that are expected to discontinue might be lower than estimated because they 
could  find  technical  solutions  or  alternatives  to  ensure  compliance.  Secondly,  if  some  companies 
close  down  effectively,  it  is  likely  that  a  part  of  their  activities  would  be  absorbed  by  other 
companies in the same sector to meet the overall demand. The same uncertainty also applies to the 
estimated job losses. First, an overestimate of discontinuations would also mean an overestimate of 
job losses. Secondly, the possible transfer of activities mentioned in this paragraph would also lead 
to  the  creation  of  jobs  that  would  partly  offset  the  quantified  impact  below.  However,  in  the 
absence of relevant  data, these likely  effects  couldn’t be quantified.  Nevertheless, it is  likely  that 
the estimated discontinuations and job losses below are overestimated.  

Other limitations were identified and are summarised in annex 4, in particular table 65 summarising 
the key limitations or uncertainties. This table indicates if these limitations might lead to under- or 
overestimates. 

With regard to the impact on Fundamental Rights, the Article 31 of the EU Charter of Fundamental 
Rights states that workers have the right to fair and just working conditions that respect their health, 
safety  and  dignity.  This  is  further  developed  in  the  EPSR which  aims  to  build  a  fairer  and  more 
inclusive European Union. Each policy option (‘PO’) that would further improve the protection of 
workers  from  the  health  risks  posed  by  exposure  (resulting  in  avoided  ill-health),  would  also 
positively impact this right. For those POs with  no impact on workers’ health, there would be no 
impact on Fundamental Rights. Given that the impact on Fundamental Rights would be equivalent 
for each substance, it is not further discussed below.   

6.1.  Cobalt and inorganic cobalt compounds 

The estimates related to cobalt and inorganic cobalt compounds outlined below take account of the 
impact  assessment  commissioned  by  Cobalt  Institute  and  data  on  exposure  levels  and  chemical 
safety  report  also  provided  by  Cobalt  Institute.  The  data  have  been  assessed  along  with  data 
obtained  from  stakeholders’  survey  and  other  available  data  sources.  With  regard  to  exposure 
levels,  exposed  workforce,  and  number  and  companies  with  exposed  workers  –  for  those  sectors 
covered by the Cobalt Insitute’s impact assessment – the estimates used for the study120 supporting 
this impact assessment are well in accordance with the data provided by Cobalt Institute.  

The  Cobalt  Institute  assessment,  however,  estimates  the  total  costs  of  compliance  significantly 
higher than estimated below.  

The  differences  between  the  Cobalt  Institute's  assessment  of  impact  and  the  external  study 
primarily  arise  from  variations  in  methodology,  assumptions  about  company  structures,  and 
compliance strategies. 

Detailed  information  on  why  Cobalt  Institute’s  estimates  differ  from  this  impact  assessment  is 
provided in annex 2.  

119 RPA (2024), op. cit.  
120 RPA (2024), op. cit.  

34 

 
 
6.1.1.  Social impacts  

(a)   Impacts on workers’ health 

Setting limit values at the level of policy option 2 (‘PO 2’) would allow for eliminating most of the 
health burden over the reference period. Under these levels of exposure, no worker would suffer of 
restrictive lung disease and upper airway irritation (representing 4,365 restrictive lung disease cases 
and 14,152 upper  airway irritation cases avoided) and the number of lung cancer cases would be 
reduced by more than 90% vis-à-vis the baseline scenario (71 out of 76 lung cancer cases).  

PO  3  would  allow  for  fully  protecting  workers  from  restrictive  lung  disease  and  for  avoiding  51 
lung  cancer cases and 12,266 upper airway irritation cases. Overall,  about  90% of all  cancer  and 
non-cancer cases would be avoided.  

The limit values provided under PO 4 would reduce by 55% the total number of cancer and non-
cancer cases over the reference period. As shown in table 11, 23 lung cancer cases, 2,842 restrictive 
lung disease and 7,363 upper airway irritation cases would be avoided.  

PO  5,  which  provides  for  the  less  stringent  combination  of  limit  values,  would  have  a  limited 
impact  on  the  total  health  burden.  12  (out  of  76  under  the  baseline  scenario)  lung  cancer  cases 
would  be  avoided  and  3,135  non-cancer  cases  would  be  avoided  (1,000  restrictive  lung  disease 
cases and 2,135 upper airway irritation cases).  The corresponding health savings are presented in 
the table below.  

The  benefits  in  terms  of  the  reduced  number  of  cases  of  ill-health  under  PO  6  would  be 
approximatively the same as under PO 4. However, since a part of these benefits will be postponed 
on average by 3 years (see annex 4) due to the transitional period, the monetary value will decrease 
by 8%, accounting for between €68 million and €69 million. 

Table 11: number of avoided cases of ill-health and monetised health benefits over 40 years (compared to 
the baseline) 

Endpoint 

PO 2 
1 / 0.5 µg/m³ 

PO 3 
5 / 1.25 µg/m³ 

PO 4 
10 / 2.5 µg/m³ 

PO 5 
20 / 4.2 µg/m³ 

PO 6 
PO 4 with 
transitional 
value at PO 5 

~PO 4 

23 
2,842 

7,363 

12 
1,000 

2,135 

€ 75 – € 74  

€ 29 – € 27  

€ 69 – € 68121 

51 
4,365 

71 (out of 76) 
4,365 (out of 
4,365) 
14,152 (out of 
14,152) 
€ 146 – € 135   € 126 – € 121 

12,266 

Lung cancer 
Restrictive lung 
disease 
Upper airway 
irritation 
Monetised health 
benefits (€ million – 
M1 – M2) 
Source: RPA (2024) 
Note: “~” means approximatively 

121 The monetary value of avoided ill-health cases is estimated to decrease by 8% as the benefits will be postponed by 
on average three years. This decrease is mainly due to the discount factor, as further explained in annex 4. 

35 

 
 
 
 
 
(b) Impacts on employment 

The impact on employment varies significantly depending on the PO. The more stringent the PO, 
the higher the need for additional risk management measures to ensure compliance and the higher 
the  impact  on  employment.  The  evidence  gathered122  suggests  that  1,086  companies  will 
discontinue, resulting in job loss for almost 26,000 workers under PO 2, representing a social cost 
of about €1.95 billion. More than a half of job losses would occur in the manufacture of tools sector 
(17,977 job losses).   

Under PO 3, the estimates indicate that more than 2,700 workers would lose their jobs. As for PO 2, 
the  manufacture  of  tools  would  be  the  most  impacted  sector  with  a  loss  of  about  1,750  jobs, 
representing  two  thirds of  total  job  losses.  POs 4  and  5  would  have  less  impacts  on  employment 
with 1,124 and 77 job losses, respectively.   

The transitional period provided under PO 6 is  expected to  result in  less job  losses  as  companies 
should use this period to avoid discontinuation (see section 6.1.2). However, the evidence gathered 
does not allow for any quantification.  

While  some  of  the  workers  made  redundant  might  easily  find  another  job,  notably  in  the  faster 
growing sectors (e.g. batteries, metal recovery), the lack of data didn’t allow to estimate the number 
of redundant workers. The above job losses numbers can therefore be considered as the worst-case 
scenario. Furthermore, as mentioned in introduction of section 6, estimates of job losses are subject 
to high uncertainties.    

6.1.2.  Economic impacts  

(a)  Impacts on businesses, including SMEs 

Under all  POs, some companies will  need to  invest in  additional  RMMs to  comply with  the  new 
limit  values,  entailing  direct  adjustment  costs.  The  magnitude  of  these  costs  varies  significantly 
between the different POs.  

For  a  limited  number  of  companies,  these  additional  costs  or  the  absence  of  appropriate  RMMs 
available on the market  that could  enable  companies to  ensure compliance with  some POs might 
endanger  their  continuation123.  Under  PO  2,  1,086  businesses  (7.1%  of  the  total  number  of 
companies  with  exposed  workers  to  cobalt)  are  expected  to  discontinue  at  least  a  part  of  their 
activities, representing a discontinuation cost of almost €6 billion. Among these businesses, 947 are 
small- and 109 medium-sized enterprises. The less stringent the POs, the lower the discontinuation 
costs as shown in table 12. Under PO 5, 10 businesses, all being small enterprises, are expected to 
discontinue, representing a discontinuation cost of €20 million.  

With  PO  6,  businesses  would  have  more  time  to  implement  major  and  expensive  changes  to 
RMMs;  developing,  finding  and  testing  substitutes  or  avoiding  discontinuations.  The  transitional 
value  provided  in  PO  6  was  highly  recommended  by  both  the  ACSH  and  social  partners,  in 

122 RPA (2024), op. cit. 
123 For the purpose of this impact assessment, it is assumed that a company will discontinue if no existing RMMs in the 
cost  model  are  sufficiently  effective  to  achieve  the  reduction  in  exposure  levels  required  to  comply  with  a  policy 
option.   

36 

 
 
 
particular  businesses,  as  part  of  their  formal  consultation.  It  is  expected  therefore  that  the 
transitional period will result in  less  discontinuations  than those estimated under PO 4. However, 
the evidence gathered does not allow for a quantification of such a decrease.    

The manufacture of tools would be the most impacted sector in terms of discontinuation under the 
first three POs.  

Table 12: number of discontinuations per company size and total discontinuation costs 

PO 2 
1 / 0.5 µg/m³ 

PO 3 
5 / 1.25 µg/m³ 

PO 4 
10 / 2.5 µg/m³ 

PO 5 
20 / 4.2 µg/m³ 

947 (out of 
12,477) 
109 (out of 
2,065) 
30 (out of 
799) 
1,086 (out of 
15,341) 
€ 5,991 

Small companies 

Middle companies 

Large companies  

Total  

Total 
discontinuation 
costs (in € million) 

Source: RPA (2024) 

128 

11 

3 

142 

51 

5 

1 

57 

10 

0 

0 

10 

€ 698 

€ 231 

€ 20 

PO 6 
PO 4 with 
transitional 
value at PO 5 

Fewer 
discontinuations 
than under PO 4 

Fewer 
discontinuation 
costs than 
under PO 4 

For the businesses remaining in the market, PO 2 would be particularly costly as it would require a 
total  investment  in  additional  RMMs  of  over  €3.65  billion  over  40  years,  of  which  €1.5  billion 
would need to be invested during the first year.  

Under POs 3 and 4, businesses would need to dedicate over the next 40 years about €1.15 billion 
(of which €708 million during the first year) and €350 million (€237 million), respectively. PO 5, 
which  provides  for  less  stringent  limit  values,  would  naturally  require  less  investments.  In  total, 
businesses  would  need  to  spend  about  €110  million  in  additional  RMMs,  of  which  €88  million 
during the first year.  

If we bring these figures down to the scale of a company, each of those would on average need to 
make investments in RMMs over the next 40 years for about €250,000 under PO 2, €75,000 under 
PO 3, €22,800 under PO 4 and €7,200 under PO 5.  

The  machining  sector  would  bear  a  significant  share  of  the  investments  in  additional  RMMs,  in 
particular  under  POs  2  and  3  for  which  these  investments  would  represent  more  than  half  of  the 
total  investments  in  RMMs  for  all  sectors  (about  €1.95  out  of  €3.65  billion  for  PO  2  and  €615 
million out of €1.15 billion for PO 3). The medical and dental devices sector would be the second 
most  impacted  sector  with  investments  representing  10%  and  15%  of  the  total  investments  to  be 
carried out under POs 2 and 3, respectively.  

With less discontinuations expected under PO 6 than under PO 4, the compliance costs for PO 6 are 
also expected to increase when companies are able to finance the investments in RMMs instead of 
closing  down.  On  the  other  side,  it  might  also  be  that  the  costs  of  RMMs  will  be  reduced  if 

37 

 
 
 
 
   
companies  can  plan  and  do  investments  as  part  of  investment  in  new  production  facilities  and 
equipment.  The possibility  to  plan and finance investments  in  RMMs  over the transitional period 
will in particular be important for SMEs. The evidence gathered does not allow for a monetisation 
or quantification of the impact of a transitional period on the compliance costs.  

The introduction of new limit values may entail air monitoring costs for those businesses which 
would  need  to  carry  out  additional  monitoring  campaigns.  The  number  of  additional  campaigns 
varies  from  0  to  2,  depending  on  several  factors,  including  the  existing  national  limit  values,  the 
size of companies124.  

According to estimates, the total air monitoring costs under PO 2 would account for €112 million, 
of  which  €23.6  million  and  €52.9  million  would  be  supported  by  small-  and  medium-sized 
enterprises,  respectively.  The  less  stringent  the  limit  values  under  the  POs,  the  lower  the  air 
monitoring costs, as shown in table 13.  

In  percentage  of  the  total  compliance  costs,  the  air  monitoring  costs  is  about  1%,  4%,  8%  and 
22.5% for the first four POs, respectively, with the highest percentage for PO 5.  

Under PO 6, it is expected that the air monitoring costs would amount to €46.8 million. Although 
the final limit values under PO 6 are equivalent to PO 4, businesses will have more time to put in 
place the necessary RMMs and demonstrate compliance. Therefore, the  total air monitoring costs 
should also be lower, mainly due to the discount factor125.  

Table 13: total estimated costs of up to two additional air monitoring campaigns in € million over 40 years 
by policy option and size of company  

Policy options 

PO 2 (1 / 0.5 µg/m³) 
PO 3 (5 / 1.25 µg/m³) 
PO 4 (10 / 2.5 µg/m³) 
PO 5 (20 / 4.2 µg/m³) 
PO 6 
Source: RPA (2024) 

Small 
23.6 
12.1 
7.2 
6.2 
6.6 

Total costs (€ million) 

Medium 
52.9 
40.5 
24.7 
17.5 
22.7 

Large 
35.6 
27.6 
19.0 
15.0 
17.5 

Total 
112.1 
80.3 
50.9 
38.8 
46.8 

The total costs related to the administrative burden of undertaking the additional air monitoring 
campaigns  for  companies  are  shown  in  table  14,  broken  down  by  PO  and  size  of  company.  The 
lower the limit values, the higher the RMMs and the higher the number of companies that need to 
carry  out  additional  monitoring  campaigns  to  demonstrate  compliance.  Therefore,  administrative 
costs are proportional to the degree of severity of the limit values considered for each PO. Overall, 
the  administrative  costs  represent  a  negligible  share  of  the  total  compliance  costs  under  all  POs, 
ranging from 0.1% (PO 2) to 2.5% (PO 5). Similarly to air monitoring costs, the costs related to the 
administrative burden are expected to amount to €6.1 million, as costs will be delayed by 3 years 
compared to PO 4. 

124 More information on the methodology to assess monitoring costs is available in annex 6.  
125 As costs will be delayed by 3 years (seeannex 4, section 7.4), they should decrease by 8% due to the discontinuation 
factor.  

38 

 
 
 
Table 14: total estimated costs of administrative burden of additional air monitoring by policy option and 
size of company over 40 years 

Policy options 

PO 2 (1 / 0.5 µg/m³) 
PO 3 (5 / 1.25 µg/m³) 
PO 4 (10 / 2.5 µg/m³) 
PO 5 (20 / 4.2 µg/m³) 
PO 6 
Source: RPA (2024) 

Small 
3.0 
1.4 
0.9 
0.8 
0.8 

  Total costs (€ million) 
Medium 
5.6 
4.1 
3.1 
2.0 
2.9 

Large 
4.6 
3.3 
2.6 
1.7 
2.4 

Total 
13.2 
8.8 
6.6 
4.5 
6.1 

If  compared  with  turnover,  small-  and  medium-sized  enterprises  would  be  more  impacted  than 
larger companies under all POs. The impact would be particularly significant under POs 2 and 3 as 
small-sized enterprises would have to dedicate on average 1.16% and 0.32% of their turnover for 
compliance  (including  adjustment,  monitoring  and  administrative  costs)  over  40  years,  and 
medium-sized  enterprises  0.65%  and  0.11%,  respectively.  In  some  sectors,  the  share  of  the 
adjustment costs compared to the turnover under PO 2 is significantly higher than the average share 
for small-sized companies, in particular in the manufacture of other porcelain and ceramic products 
(3.08%), manufacture of tools (2.17%), manufacture of other fabricated metal products (2.10%) and 
manufacture of medical and dental instruments and supplies (2.04%). The impact of POs 4, 5 and 6 
is more limited, with small enterprises having to invest between 0.1% and 0.02% of their turnover, 
and medium enterprises 0.04% and 0.009%.  

All POs would also positively impact businesses as they would allow for cost savings from reduced 
ill-health.  PO 2 would entail  the highest benefits  for employers as  it would  also  have the highest 
positive health impacts. Under this PO, businesses would save €1.6 million over 40 years against 
0.4 million under PO 5 over the same period. The costs savings under POs 3, 4 and 6 would be in 
between  with  €1.5,  €1  million  and  €0.9  million,  respectively.  These  benefits  are  negligible 
compared to the costs to businesses and are therefore not expected to mitigate the impacts described 
above. 

(b) Impacts on competitiveness 

Although of different extent, all POs are likely to have impacts on cost and price competitiveness 
as some businesses are expected to discontinue, partly or totally, due to the high compliance costs 
or the current absence of appropriate RMMs enabling some companies to comply with some POs. 
Such an impact would particularly occur under PO 2, especially for the manufacture of tools sector 
where more than 4% of the companies would discontinue (30% if we only consider companies with 
exposed  workers  to  cobalt),  which  could  affect  product  availability  and  prices.  Under  all  other 
options, estimated discontinuations are not expected to result in significant changes in any sector. 

Under  all  POs  except  PO  2,  the  total  adjustment  costs  are  below  1%  of  turnover  for  all  sectors 
(including SMEs), and in most cases even below 0.1%. With regard to PO 2, adjustment costs can 
represent  up  to  3%  (small-sized  companies  in  the  manufacture  of  other  porcelain  and  ceramic 
products  sector).  Only  SMEs  in  the  following  sectors  would  face  adjustment  costs  representing 

39 

 
 
 
 
more than 1%126 of the turnover: manufacture of other porcelain and ceramic products, manufacture 
of  tools,  manufacture  of  other  fabricated  metal  products,  manufacture  of  medical  and  dental 
instruments  and  supplies,  machining,  manufacture  of  electronic  components  and  boards, 
manufacture  of  motor  vehicles,  manufacture  of  air  aid  spacecraft  and  related  machinery,  and 
forging, pressing, stamping and roll-forming of metal; powder metallurgy.  

Therefore, overall impacts of POs 3, 4, 5 and 6 on businesses should have no or limited impacts on 
consumer  choices  and  prices  as  companies  are  expected  to  absorb  costs  which  represent  a  small 
share  of  their  turnover  and  no  sector  should  be  significantly  impacted  by  discontinuations. 
Regarding  PO  2,  consumers  are  expected  to  be  impacted  by  higher  prices  or  lower  diversity  of 
supply in  sectors  where  SMEs would face  high  adjustment costs compared to  their turnover127 or 
sectors would be characterised by a significant number of estimated discontinuations compared to 
the total number of companies with exposed workers128.  

With regard to the EU’s main competitors, only Canada and Japan have binding limit values for the 
inhalable fraction or total dust comparable to PO 5. The other competitors have limit values higher 
than  PO  5,  or  no  binding  limit  values  for  cobalt.  Therefore,  under  all  POs,  the  international 
competitiveness  of  EU-based  companies  could  be  impacted  when  compared  to  their  competitors 
who will operate without incurring the capital and operating costs of compliance with a lower limit 
value.  Non-EU  countries  often  have  different  compliance  rules  and  methods  to  define  exposure, 
which makes the comparison uncertain.    

Consequently,  some  companies  operating  within  the  most  impacted  sectors  might  consider  the 
possibility to relocate their activities outside the EU129. However, except under PO 2, the average 
compliance  costs  per  company  compared  to  the  turnover  are  not  expected  to  be  particularly 
significant  and  should  therefore  not  exceed  the  costs  of  relocation  of  activities.  Therefore,  the 
impact on international competitiveness from POs 3 to 6 should be limited and is not expected to 
impede the objective of increasing the overall competitiveness of the EU.  

The  impact  on  capacity  to  innovate  is  expected  to  be  significant  in  some  sectors  under  PO  2. 
According  to  the  evidence  gathered,  the  total  compliance  costs  in  the  following  5  sectors  would 
represent more than 20% of their expenditures in research and development (R&D) over 40 years: 
manufacture  of  tools  (53%)  manufacture  of  other  fabricated  metal  products  (36.5%),  forging, 
pressing,  stamping  and  roll-forming  of  metal;  powder  metallurgy  (25%),  manufacture  of  electric 
components and boards  (23.5%) and recovery of sorted materials  (20.5%). The resources used to 
comply with PO 2 would therefore not be available for R&D activities. Under the other four POs, 
the share of the total compliance costs compared to the R&D expenditures is lower than 10%, and 
even 1% in most sectors and POs.  

126 Although the profitability ratio diverge from one sector to another, 1% of turnover was chosen for the purpose  of 
this impact assessment, in line with previous impact assessments in the area of occupational safety and health. 
127 (1) Manufacture of other porcelain and ceramic products, (2) forging, pressing, stamping and roll-forming of metal; 
powder metallurgy; (3) machining, (4) manufacture of tools, (5) manufacture of other fabricated metal products n.e.c., 
(6) manufacture of electronic components and boards, (7) manufacture  of motor vehicles, (8) manufacture of air and 
spacecraft and related machinery, (9) manufacture of medical and dental instruments and supplies.  
128 In particular (1) Manufacture of tools, and (2) Manufacture of other porcelain and ceramic products.  
129 RPA (2024, op. cit. As part of the stakeholders consultation, one large company indicated that they may relocate the 
most dusty processes with the highest exposure concentrations to countries outside the EU. 

40 

 
 
(c)  Impacts on the single market 

No Member State has an equivalent combination of limit values to those assessed in this report. For 
instance,  despite  that  several  Member  States  already  have  a  limit  value  of  20  µg/m3  (inhalable 
fraction),  it  does  not  apply  to  the  same  scope130  or  is  not  combined  with  a  limit  value  for  the 
respirable  fraction.  Furthermore,  5  Member  States  currently  have  no  limit  value  for  cobalt. 
Therefore,  introducing  a  combination  of  limit  value  covering  both  the  respirable  and  inhalable 
fraction, whatever  their levels,  would lead to  a more  level  playing field  within the single market, 
improving  its  functioning.  In  the  absence  of  further  information,  this  impact  could  not  be 
quantified.  

(d) Impacts on public authorities/Member States  

No Member State has currently an existing combination of limit values for cobalt and its inorganic 
compounds  in  its  national  legislation.  Therefore,  they  will  all  need  to  revise  their  legislations, 
which  will  entail  transposition  costs.  Consequently,  the  total  costs  for  transposition  will  be  the 
same under each PO: €910,000131. 

All POs would improve the protection of workers, resulting in less ill-health cases over the next 40 
years.  POs  2  and  3  in  particular  would  allow  for  a  significant  reduction  of  the  health  burden, 
resulting  in  avoided  healthcare  treatment  costs  for  public  authorities  of  about  €8.1  and  €7.2 
million, respectively.  Although  the positive impact  on health is  less significant,  public authorities 
would  still  benefit  from  a  reduction  of  costs  under  POs  4,  5  and  6  (€4.4,  €1.5,  and  €4  million, 
respectively).  

All POs might also be beneficial for those Member States which currently have no limit value and 
would  like  to  set  one.  Under  all  POs,  the  5  Member  States  would  not  have  to  carry  out  an 
assessment in view of setting limit values for cobalt. This could represent a benefit of €500,000 in 
total for the 5 Member States, irrespective of the PO.  

Under all options, the benefits to public authorities would outweigh the costs.  

The Member States with the highest share of companies comprise Czechia, France, Germany, Italy 
and Poland. It can therefore be expected that industries in these Member States will face the largest 
compliance  costs.  These  five  Member  States  accounts  for  about  60%  of  the  companies  and 
therefore, they could also face around 60% of impacts (depending on the current RMMs in place). 
The mentioned Member States are also for the most the larger Member States. If compared to the 
total  size  of  the  industry,  there  is  overrepresentation  of  companies  in  Czechia,  Italy,  Poland  and 
Slovakia.  This  is  a  reflection  of  large  metal  industries  in  these  Member  States.  Therefore,  also 
considering that the larges costs by sector include Machining and Manufacture of metal tools, these 
Member States are likely to be most affected. Among these 4 Member States, Poland, which has an 
existing binding limit value of 20 µg/m³ (inhalable) should be the less impacted. While Italy has no 
limit value for cobalt, Czechia and Slovakia have a binding limit value of 50 µg/m³ (inhalable). 

130 Some limit values apply to less cobalt compounds or to cobalt only. 
131 In accordance with the previous impact assessments,  it is assumed that the transpositions costs for Member States 
with  currently  no  limit  values  (IT,  LU,  MT,  PT,  SI)  would  be  of  €50,000,  and  of €30,000  for  those  with  an  already 
existing limit value.  

41 

 
 
It also means that the expected reduction in discontinuation from the transitional value provided by 
PO 6 will also benefit all Member States identified in the previous paragraph.  

(e)  Impacts on digitalisation   

No PO is expected to have an impact on digitalisation.  

(f)  Impacts on EU Open Strategic Autonomy 

Cobalt  is  a  critical  raw  material  and  is  used  in  key  technologies  ensuring  a  successful  green 
transition (e.g. batteries for electric vehicles and storage and magnets in wind turbines). Depending 
on their levels, limit values for cobalt and inorganic cobalt compounds may result in higher costs of 
recycling cobalt and thereby have a negative impact in this area. As a possible consequence, the EU 
would remain dependent on other countries for its supply of cobalt, which goes against its objective 
of open strategic autonomy.  

Under PO 2, 10% of businesses with workers exposed to cobalt operating in metal recovery sector 
are estimated to  discontinue their activities. The  compliance costs  would  represent  up to  0.7% of 
the  average  turnover  in  the  sector  (7.83%  of  the  gross  operating  surplus).  Therefore,  PO  2  could 
negatively  impact  the EU objective of  open  strategic  autonomy. PO 3 is expected to  result in the 
discontinuation of  0.5% of businesses  operating  in  this  sector.  Furthermore, the compliance  costs 
would  not  exceed  0.04%  of  the  turnover  (0.49%  of  the  gross  operating  surplus).  Therefore,  the 
impact under PO 3 would be negligible. Under PO 4 and PO 5, no discontinuation is estimated for 
the  metal  recovery  sector  and  the  compliance  costs  would  represent  less  than  0.003%  of  the 
turnover (0.04% of the gross operating surplus). Therefore, POs 4 and 5 would have no impact on 
the EU objective of open strategic autonomy. Finally, the transitional period provided under PO 6 
would give more time to plan investments, which would further reduce the already limited impacts 
arising from a limit value at the level of PO 3.    

6.1.3.  Environmental impacts  

(a)  Direct impacts on environment   

To meet the new limit values, businesses might need to invest in alternative technical RMMs such 
as  closed  systems,  partially  closed  systems,  self-contained  breathing  apparatus,  half  and  full 
facemasks and open hoods. The choice of these RMM will depend on the RMMs currently in place 
(see annex 6) and the PO. However, it is unlikely that the alternative RMMs contribute to higher 
releases of cobalt in the air. Therefore, the direct impact of all POs on the environment should be 
negligible or even zero.   

(b) Indirect impacts on environment   

The table below provides theoretical impacts on some of the objectives of the EU Green Deal. 

Table 15: theoretical impacts of the introduction of limit values for cobalt and its inorganic compounds on 
the objectives of the EU Green Deal 

Objectives of the EU Green 
Deal 

Theoretical impacts 

Mobilising  industry  for  a  clean 
and circular economy  

See ‘impacts  on EU  Open Strategic Autonomy’ under section 
6.1.2. 

Accelerating 

the 

shift 

to  Limit values may in the short term increase the costs of 

42 

 
sustainable and smart mobility  

Supplying  clean,  affordable  and 
secure energy 

batteries for vehicles and thereby have a negative impact on 
the shift to sustainable and smart mobility. 
In  the  longer  term,  the  introduction  of  limit  values  may  be  a 
driver for development  of alternatives and  reduce the demand 
for critical raw materials (cobalt), and thereby have a positive 
impact on the shift to sustainable and smart mobility. 

Limit values may increase costs of renewable energy sources 
(e.g. increased costs of magnets) and energy storage systems 
(e.g. increased costs of batteries).  
In the longer term, the introduction of limit values may be a 
driver for development of alternatives and reduce the demand 
for cobalt, and thereby have a positive impact on the supply of 
clean, affordable and secure energy.   

The  key  sectors  for  the  green  transition  are:  manufacture  of  batteries  and  accumulators, 
manufacture  of  motor  vehicles,  manufacture  of  air  and  spacecraft  and  related  machinery  and 
recovery of sorted materials. PO 2 would hamper the Green Deal’s objectives as some companies 
operating  in  the  above-mentioned  sectors  would  discontinue  (batteries  and  accumulators:  1%  of 
businesses;  motor  vehicles:  10%;  air  and  spacecraft:  11%;  and  recovery:  10%).  Furthermore,  the 
total adjustments costs would represent a high share of the gross operating surplus, in particular for 
SMEs operating in the manufacture of motor vehicles (up to 33%) and in the manufacture of air and 
spacecraft and related machinery (15%). 

Although to a lesser extent, PO 3 would also negatively impact the capacity of the Green Deal to 
deliver on some of its objectives. While the number of discontinuations for the sectors relevant to 
the Green Deal should remain limited (motor vehicles: 1%; air and spacecraft: 2.5%; and recovery: 
0.5%), the adjustments costs compared to the gross operating surplus would approach the 5% for 
SMEs  operating  in  the  manufacture  of  motor  vehicles  and  of  air  and  spacecraft  and  related 
machinery.  

POs 4 and 5 are not expected to have a negative impact on the Green Deal. There would indeed be 
no  discontinuation  except  under  PO  4  for  businesses  operating  in  the  manufacture  of  air  and 
spacecraft  and  related  machinery  (0.5%  of  businesses  discontinuing).  Furthermore,  the  total 
adjustment costs should remain very limited compared to the operating surplus, representing up to 
0.5% of the gross operating surplus, except for SMEs manufacturing air and spacecraft and related 
machinery  which  would  have  to  dedicate  about  1%  of  their  gross  operating  surplus  under  PO  4. 
Therefore, the impact of POs 4 and 5 on the Green Deal should be negligible or even zero.  

The  transitional  period  provided  by  in  PO  6  should  be  beneficial  to  SMEs  operating  in  the 
manufacture of air and spacecraft and related machinery, which would have more time to plan their 
investments.  Therefore,  this  could  result  in  less  discontinuations,  which  would  further  reduce  the 
already negligible impact of PO 4 on the Green Deal.  

In the longer term, the introduction of limit values may be a driver for development of alternatives 
and  reduce  the  demand  for  cobalt,  and  thereby  have  a  positive  impact  on  the  supply  of  clean, 
affordable  and  secure  energy.  However,  the  evidence  gathered  did  not  allow  for  a  more  detailed 
assessment of this theoretical positive impact.   

43 

 
 
6.2. 

PAHs 

6.2.1.  Social impacts  

(a)  Impacts on workers’ health 

All POs would entail benefits for workers by reducing the number of ill-health cases compared to 
the baseline over 40 years. However, the magnitude of this impact varies greatly between the POs. 
The  lowest  limit  value,  PO  2,  would  have  the  most  significant  impact  with  3,336  (out  of  3,355 
estimated  under the baseline) ill-health cases avoided over 40 years, including  nearly 90% of the 
cases of lung cancer and 100% of the cases for the other estimated endpoints.  

PO  3  would  also  be  effective  in  protecting  workers  from  non-cancer  ill-health  since  it  would 
eliminate all cases of developmental toxicity and male infertility. However,  it would only prevent 
less than one fourth of the lung cancer cases compared to the baseline (35 out of 160). PO 4 would 
not  bring  significant  improvement  for  preventing  work-related  diseases  related  to  exposure  to 
PAHs.  At  700  ng/m³,  less  than  20%  of  the  total  ill-health  cases  would  be  prevented,  including  2 
lung cancer cases only. Despite the transitional value, it is expected that the number of avoided ill-
health  cases  under  PO  5  should  be  similar  to  PO  3132.  The  table  below  summarizes  the  avoided 
cases over 40 years for each PO and also provides a monetisation of these direct positive impacts.  

  Table 16: n° of avoided cases of ill-health and monetised health benefits over 40 years (against the 
baseline) 

Endpoint 

PO 2 
7 ng/m³ 

PO 3 
70 ng/m³ 

PO 4 
700 ng/m³ 

PO 5 
PO 3 with 
transitional 
value at 140 
ng/m³ for 9 
sectors 

~PO 3 

35 

38 
3,157 

2 

7 
608 

€ 97 – € 16 

€ 15 – € 1 

€ 13.8 - € 0.9133 

Lung cancer 

141 (out of 
160) 

Developmental toxicity  38 (out of 38) 
3,157 (out of 
Male infertility 
3,157) 
€ 182 – € 59 

Monetised health 
benefits (€ million – 
M1 – M2) 
Source: RPA (2024) 

(b) Impacts on employment 

Impacts  on  employment  are  expected  under  POs  2  and  3,  as  a  number  of  companies  might  be 
forced to discontinue (see economic impacts related sections). As a result of these discontinuations, 
about 47,500 (PO2) and 2,700 (PO3) workers are expected to lose their jobs out of the 1,285,000 

132 The reduction of ill-health cases should be postponed by three years as explained in the methodological note.  
133 The monetary value of avoided ill-health cases is estimated to decrease by 8% as the benefits will be postponed by 
on average three years. This decrease is mainly due to the discount factor, as further explained in annex 4. 

44 

 
 
 
 
 
workers currently exposed to PAHs in the EU. The social costs related to those job losses would be 
of about €4 billion and €0.25 billion for those two options, respectively.  

Even  if  most  of  the  sectors  would  be  impacted  under  PO  2,  the  impact  on  employment  would 
represent  more  than  60%  of  workers  active  in  the  following  sectors:  welding  of  railroad  tracks 
(17,735 workers, representing 37% of the total number of job losses), petroleum refineries (5,739, 
12%) and steel and iron foundries, ferroalloys (5,499, 11.5%).  

Although its overall impact would be less significant, PO 3 would mainly impact workers operating 
in the following sectors: steel and iron foundries, ferroalloys (550, 20.5%), soil remediation (511, 
19%), coking plants (479, 18%) and coal tar distillation (437, 16%). 

Although  the evidence gathered does not  allow for a quantification,  PO 5 is  expected to  result in 
less  discontinuations  than  PO  3  (see  section  6.2.2).  Consequently,  it  is  also  expected  that  the 
number of job losses should be lower under PO 5 than under PO 3.  

The  evidence  gathered  does  not  allow  for  estimating  the  number  of  workers  which  would  find  a 
new job following the discontinuation of their companies. No impact on employment is expected 
under PO 4. 

6.2.2.  Economic impacts  

(a)  Impacts on businesses, including SMEs  

Under  POs  2  and  3,  some  companies  are  expected  to  discontinue  because  of  the  significant 
investments  that  they  would  need  to  make  for  complying  with  the  new  limit  values.  The  impact 
would  be  particularly  significant  under  PO  2,  with  3,462  companies  estimated  to  discontinue  at 
least a part of their activities, all sectors combined. With a higher limit value, PO 3 is estimated to 
entail  146  discontinuations.  In  total,  it  would  represent  a  discontinuation  cost  (considered  as 
adjustment  costs)  of  €32  billion  and  €2.25  billion,  respectively.  No  discontinuation  is  expected 
under PO 4. 

Under PO 2, 3 sectors would represent together more than four fifths of the total discontinuations: 
welding of railroad tracks (1,109 discontinuations, representing 32% of the total discontinuations), 
chimney  sweeps  (969,  28%)  and  soil  remediation  (726,  21%).  The  latter  would  continue  to  face 
difficulties under PO 3, with 68 discontinuations (representing 46.5% of the total discontinuations), 
followed by steel and iron foundries, ferroalloys (28, 19%) and coking plants (25, 17%). 

Whether  under  PO  2  or  3,  most  of  those  companies  which  would  discontinue  are  small-sized 
enterprises  (93%  and  88%,  respectively).  Although  less  impacted,  103  medium-sized  enterprises 
are  expected  to  discontinue  under  PO  2,  against  6  under  PO  3.  The  share  of  SMEs  in  the  total 
discontinuation costs is lower. They would represent just under 40% for both POs. This difference 
is due to the lower turnover of SMEs compared to large companies134.    

With PO 5, businesses operating in the sector subject to the transitional value135 would have more 
time  to  implement  major  and  expensive  changes  to  RMMs;  developing,  finding  and  testing 

134 The discontinuation cost is taken as the loss of profit over 20 years and the average profit is assumed to be 10% of 
turnover of an average company in sector. 
135  Until  6  years  after  entry  into  force  of  the  Directive  for  the  following  sectors:  (1)  steel  and  iron  foundries,  which 
includes ferroalloy manufacturers, (2) aluminium manufacturers, (3) carbon and graphite electrode manufacturers, (4) 

45 

 
 
 
substitutes  or  avoiding  discontinuations.  The  transitional  value  provided  in  PO  5  was  highly 
recommended  by  both  the  ACSH  and  social  partners,  in  particular  businesses,  as  part  of  their 
formal  consultation.  It  is  therefore  expected  that  the  transitional  period  will  result  in  less 
discontinuations than those estimated under PO 3. However, the evidence gathered does not allow 
for a quantification of such a  decrease. As most of the  companies estimated to  discontinue under 
PO 3 are SMEs, the introduction of the transitional period provided in PO 5 should mainly benefit 
them.    

Table 17: number of discontinuations, including per company size and total discontinuation costs 

PO 2 
7 ng/m³ 

PO 3 
70 ng/m³ 

PO 4 
700 ng/m³ 

Small companies 

Middle 
companies 
Large companies   103 (out of 841) 
Total  

3,226 (out of 
436,466) 
132 (out of 
3,001) 

3,462 (out of 
440,308) 
€ 32,392.40 

Total 
discontinuation 
costs (in € 
million) 
Source: RPA (2024) 

129 

6 

11 
146 

0 

0 

0 
0 

€ 2,248.28 

€ 0 

PO 5 
PO 3 with 
transitional value 
at 140 ng/m³ for 9 
sectors 

Fewer 
discontinuations 
than under PO 3 

Fewer 
discontinuation 
costs than 
under PO 3 

Some  of  the  companies  that  would  not  discontinue  would  need  to  invest  in  additional  RMMs  to 
comply with the new limit value, depending on their current levels of exposure and RMMs. Under 
PO 2, businesses would need to invest about €4.6 billion over 40 years, of which €1.7 billion during 
the  first  year.  The  impact  of  POs  3  and  4  on  the  need  for  investments  in  RMMs  would  be  less 
significant  as businesses would need to  dedicate €417 million  and €3.3 million over 40 years (of 
which €220.90 million and 4.5 million136 during the first year).  

The  most  impacted  sectors  in  terms  of  investments  in  additional  RMMs,  irrespective  of  the 
company size, would be casting of metals (€1.2 billion over 40 years), road paving (€1.15 billion) 
and  chimney  sweeps  (€765  million).  While  most  of  the  investments  required  for  the  road  paving 
sector  would  be  recurrent  (about  93%),  the  two  other  sectors  would  need  to  make  about  50%  of 
their investments during the first year.  

Under  POs  3,  2  sectors  would  concentrate  almost  two  thirds  of  the  required  investments:  road 
paving (€161.5 million)  and welding of  railroad  tracks (€ 102 million).  Under PO 3, investments 
supported by the road paving sector would be mainly recurrent (about 90%), while one third of the 

coking plants, (5) coal tar distillation, (6) refractory products manufacturers, (7) welding of train tracks, (8) other non-
ferrous metallurgical processes, and (9) casting of metals. 
136  It  is  assumed  that  some  sectors  would  move  from  RMMs  with  high  recurrent  costs  (e.g.  respiratory  protective 
equipment) to RMMs with lesser recurrent costs over the same period (e.g. closed system).  

46 

 
 
 
 
   
 
investments made by companies operating in the welding of railroad tracks sector would need to be 
done  during  the  first  year.  Under  PO  4,  the  total  investments  are  less  significant  and  would  be 
mainly supported by the welding of railroad tracks sector (€3 million out of €3.3 million).     

More than 95% of the companies operating in the two sectors mentioned in the previous paragraph 
are  SMEs,  which  are  usually  characterised  by  less  financial  resources  to  make  investments,  in 
particular one-off investments (during the first year).  

With less discontinuations expected under PO 5 than under PO 3, the costs of additional RMMs for 
PO 5 are also expected to increase when companies operating in the 9 targeted sectors are able to 
finance the investments in RMMs instead of closing down. On the other side, it might also be that 
the costs of RMMs will be reduced if companies have the opportunity to plan and do investments as 
part of investments in new production facilities and equipment. The possibility to plan and finance 
investments  in  RMMs  over  the  transitional  period  will  in  particular  be  important  for  SMEs.  The 
evidence gathered does not allow for a monetisation or quantification of the impact of a transitional 
period on the compliance costs.  

While no Member State currently has a limit  value at  the level  of  PO 2, one (DE) and  four (DE, 
LV, BG and NL) Member States have currently a limit value below PO 3 (+ final OEL under PO 5) 
and  PO  4,  representing  11%  and  18%  of  businesses,  respectively.  Consequently,  all  enterprises 
would need to undertake additional air monitoring at PO 2 and over 80% at POs 3, 4 and 5.    

PO 2 would represent a total monitoring cost of €550 million, against €292, €181 and €291 million 
under POs 3, 4 and 5, respectively. Under the three POs, most of these costs would be supported by 
SMEs, since they represent the largest part of the companies with exposed workers to PAHs.  

Table 18: total estimated costs of up to two additional air monitoring campaigns in € million over 40 years 
by policy option and size of company  

Policy options 

PO 2 (7 ng/m³) 
PO 3 (70 ng/m³) 
PO 4 (700 ng/m³) 
PO 5 
Source: RPA (2024) 

Total costs (€ million) 

Small 
498.25 
255.97 
157.69 
254.81 

Medium 
36.28 
25.72 
16.6 
25.60 

Large 
14.93 
10.47 
7.04 
10.42 

Total 
549.46 
292.16 
181.33 
290.84 

The  total  administration  costs  related  to  the  running  of  air  monitoring  are  shown  in  table  19 
below.  As  for  the  monitoring  costs,  most  of  the  administrative  costs  are  attributed  to  SMEs,  in 
particular  small  companies.  The  lower  the  limit  value  associated  with  the  PO,  the  higher  the 
administrative costs.  

Table 19: total estimated costs of administrative burden of additional air monitoring by policy option and 
size of company over 40 years 

Policy options 

PO 2 (7 ng/m³) 
PO 3 (70 ng/m³) 
PO 4 (700 ng/m³) 
PO 5 
Source: RPA (2024) 

Small 
104.49 
55.79 
34.37 
55.56 

Total costs (€ million) 

Large 
4.83 
3.60 
2.42 
3.59 

Total 
117.53 
65.54 
40.76 
65.27 

Medium 
8.21 
6.15 
3.97 
6.13 

47 

 
 
In total,  compliance costs for companies under  PO 2 would be of  about  €37.5 billion, against €3 
billion, €225 million and €2.9 billion under POs 3, 4 and 5, respectively. Under POs 2 and 3, more 
than  three  fourths  of  the  compliance  costs  are  due  to  the  companies  discontinuing.  For  PO  4, 
monitoring and administrative costs account for more than 95% of the total compliance costs.  

All POs would positively impact businesses as they would allow for cost savings from reduced ill-
health. The most significant benefit would be under PO 2, with cost savings estimated at €540,000, 
against €130,000, €10,000 and €120,000 under POs 3, 4 and 5, respectively.  

(b) Impacts on competitiveness  

POs  2  and  3  would  have  impacts  on  cost  and  price  competitiveness  with  some  businesses 
estimated  to  possibly  discontinue,  partly  or  totally,  due  to  the  high  compliance  costs.  Certain 
sectors would be particularly affected by PO 2 which would result in the above-mentioned possible 
discontinuations. Among these sectors are  coking plants (100% of the companies are expected to 
discontinue), welding of railroad tracks (44%), soil remediation (17%) and steel and iron foundries, 
ferroalloys  (10%).  Furthermore,  PO  2  is  expected  to  entail  first  year  compliance  costs  (minus 
discontinuation costs) representing more than 10% of the gross operating surplus for 13 sectors137. 
Except  for  graphite  and  electrode  manufacturers,  these  sectors  are  mainly  composed  of  SMEs, 
which  have  less  capacity  to  absorb  additional  costs.  Therefore,  it  is  likely  that  a  share  of  the 
adjustment costs generated by PO 2 will be passed on to consumers.   

Under  PO  3,  one  sector  is  estimated  to  be  particularly  impacted  with  discontinuations,  i.e.  the 
coking plants sector with 45% of companies estimated to discontinue, which would have negative 
impacts  on  consumers  both  in  terms  of  diversity  of  supply  and  prices.  Furthermore,  6  sectors138 
should face first year compliance costs (minus discontinuation costs) representing more than 10% 
of the gross operating surplus. These sectors are mainly composed of SMEs, which are unlikely to 
absorb  additional  costs.  Therefore,  consumers  could  be  impacted  with  a  share  of  the  costs  being 
passed on to them. However, the shares of first year compliance costs compared to gross operating 
surplus are less significant than under PO 2. Therefore, the impact of PO 3 on consumers should 
also be less. No discontinuation is expected under option 4 and the compliance costs represent less 
than 10% of gross operating surplus. Therefore, the impact on consumers should be more limited, 
although an increase in prices cannot be excluded given the high share of SMEs.  

With its transitional period, PO 5 should have less impact on cost and price competitiveness than 
PO 3 (which does not have transitional period). Indeed, businesses targeted by PO 5 will have the 
opportunity to better plan and finance the necessary investments, which might reduce the share of 
costs  that  would  be  passed  on  to  consumers.  Furthermore,  the  possible  positive  impact  on  the 
number  of  discontinuations  (expected  to  decrease)  for  the  coking  plants  sector  would  reduce 
pressure on cost and price competitiveness, and on the diversity of supply. Nevertheless, the impact 
on  consumers  cannot  be  excluded  as  compliance  costs  compared  to  gross  operating  surplus  will 
remain  high  for  some  sectors,  in  particular  graphite  and  carbon  electrode  manufacture,  coking 
plants and other non-ferrous metallurgy. Furthermore, while the transitional measure is expected to 

137  (1)  Wood  preservation,  (2)  petroleum  refineries,  (3)  manufacture  of  refractory  products,  (4)  manufacture  of 
bituminous  products,  (5)  graphite  and  carbon  electrode  manufacturers,  (6)  steel  and  iron  foundries,  ferroalloys,  (7) 
manufacture  of aluminium, (8) other non-ferrous metallurgy, (9)  casting of metals, (10) coal fired power plants, (11) 
soil remediation, (12) welding of train tracks, and (13) chimney sweeps. 
138 (1) coking plants, (2) manufacture of refractory products, (3) graphite and carbon electrode manufacturers, (4) steel 
and iron foundries, ferroalloys, (5) other non-ferrous metallurgy, and (5) coal fired power plants. 

48 

 
 
reduce  discontinuations,  it  cannot  be  excluded  that  some  companies  would  close  down  anyway, 
impacting negatively the diversity of supply and prices.  

With regard to the impact on international competitiveness, certain non-EU competitors such as 
Canada, Japan, Norway, South Korea and Switzerland have binding limit values comparable to PO 
4,  or  even  below  in  some  of  them.  Other  competitors  such  as  China,  India,  Australia,  Turkey  or 
Russia have no limit value for PAHs. Non-EU countries often have different compliance rules and 
methods to define exposure, which makes the comparison uncertain.    

Since 99% of the companies with  workers  exposed to  PAHs  are  small  companies, they  are more 
likely  to  operate  at  national  scale  and  the  possibility  of  relocation  in  or  import  from  non-EU 
countries  is  limited.  However,  sectors  such  as  steel  and  iron  foundries,  ferroalloys,  aluminium 
manufacturers, other metallurgy, casting of metal and graphite and carbon electrode manufacturers 
already  experience  pressure  from  cheaper  imports,  particularly  Asian  countries139.  An  increase  in 
operational costs resulting from compliance costs could lead to discussions about the possibility to 
relocate their activities outside the EU. It is particularly the case under PO 2, and to a lesser extent 
under  PO  3.  Under  PO  5,  businesses  will  have  more  time  to  plan  their  investments  or  find 
alternatives,  which  should  reduce  the  impact  on  international  competitiveness.  Given  the  limited 
costs compared to gross operating surplus under PO 4, the impact on international competitiveness 
is considered as negligible.  

Furthermore, the impact on coking plants resulting in possible discontinuations, in particular under 
PO 2 and to a lesser extent under PO 3, could also negatively impact downstream sectors (including 
coal  tar  distillation  plants,  and  carbon  and  graphite  electrode  manufacturers)  requiring  coking 
plants’ by-product coal tar for their production. Among the products requiring coal tar are batteries 
storing  energy  produced  by  wind  turbines,  semiconductors  and  electric  vehicles.  A  more  limited 
availability of these products would lead to greater dependence on countries outside the EU. With 
its  6-years  transitional  period  applying  among  others  to  coking  plants  as  provided  by  PO  5, 
businesses would have more time to plan their investments or find alternatives, which  is likely to 
result in less discontinuations, and therefore lower impact on downstream users in terms of imports 
from outside Europe. Under PO 4, no discontinuation is expected, and there should therefore be no 
impact on downstream sectors.  

The impact on capacity to innovate is closely linked to the level of compliance costs, which divert 
resources  from  other  purposes,  potentially  including  R&D.  Under  PO  2,  compliance  costs 
significantly  outweigh  the  available  R&D  funding  for  most  companies,  with  a  few  exceptions140. 
Although compliance costs would represent a small percentage of the R&D under PO 3, the impact 
on the capacity to innovate cannot be excluded, in particular for SMEs operating in the following 
sectors:  coking  plants  (compliance  costs  represent  about  160%  of  the  R&D  expenditures),  soil 
remediation  (155%),  welding  of  railroad  tracks  (120-135%)  and  other  non-ferrous  metallurgy 
(50%).  The  impact  of  PO  4  on  the  capacity  to  innovate  should  be  negligible  given  the  low 
compliance costs. By having more time to plan and finance the necessary investments in additional 
RMMs, the impact on capacity to innovate under PO 5 could be lower that under PO 3. However, 
the  compliance  costs  for  the  sectors  identified  above  would  remain  high  compared  to  turnover. 
Therefore,  the  impact  on  capacity  to  innovate  for  coking  plants,  soil  remediations,  welding  of 
railroad tracks and other non-ferrous metallurgy sectors cannot be excluded.  

139 RPA (2024), op. cit., stakeholder consultation.  
140 Smokehouses, manufacture of bituminous products and waste incineration, for which costs as a percentage of R&D 
expenditures remain proportionally low.   

49 

 
 
(c)  Impacts on the single market 

11  Member  States  currently  have  no  limit  values  for  PAHs.  Among  those  with  an  existing  limit 
value, the levels vary greatly, ranging from 70 ng/m³ to 5000 ng/m³. Most of Member States with a 
limit value operate at levels around PO 4, except BG, DE, LV and NL. Therefore, POs 2, 3 and 5 
are likely to have a positive impact on the functioning of the single market, by creating a more level 
playing field.   

(d) Impacts on public authorities/Member States   

About 438,000 firefighters are assumed to be exposed to airborne PAHs in the EU 141. Firefighters 
are employed by public authorities, not private businesses. Public authorities may therefore have to 
bear compliance costs. The current exposure data indicates that all firefighters are exposed to levels 
below 70 ng/m3 . Therefore, it is assumed that no additional RMMs (adjustment costs) would be 
required under PO 4. As firefighters are not subject to the transitional period provided for by PO 5, 
the impact of the latter on public authorities is equivalent to PO 3 and will not be further discussed, 
except for the costs related to the preparatory work.  

Whilst  current  exposure  levels  are  expected  to  be  lower  than  PO  3,  5%  of  the  public  authorities 
have levels close to it (69.62 ng/ m3)142. Therefore, it is expected that these public authorities will 
need to invest in alternative RMMs as a precaution, accounting for €62.5 million over 40 years, of 
which  €16  million  would  be  spent  during  the  first  year.  Under  PO  2,  all  public  authorities  are 
expected to invest in alternative RMMs as the exposure is higher than the limit value associate with 
this option. In total, these investments would represent about €5.9 billion (of which about €550 for 
the first year). 

All  POs  would  entail  monitoring  costs.  These  costs  estimates  vary  depending  on  the  number  of 
Member States with existing limit values and their levels. The total monitoring costs would range 
from  €240,000  to  €870,000  over  40  years,  depending  on  the  PO,  with  PO  4  entailing  the  lowest 
costs.  These  monitoring  costs  are  relatively  low  as  public  authorities  would  only  undertake  air 
monitoring on sample groups. The administrative costs for air monitoring would be proportionally 
low for the same reasons, with  administrative costs ranging from  € 50,000 and €180,000 over 40 
years.  

At  all  options,  public  authorities  would  save  money  through  reduced  cases  of  ill-health  cases. 
With its low impact on workers’ health, PO 4 would allow public authorities to save just €690,000 
over  40  years,  mainly  due  to  the  reduction  of  male  infertility  cases.  POs  3  and  2  would  result in 
higher  avoided  costs  of  approximatively  €3.9  and  €5.3  million,  respectively.  The  difference 
between the two is explained by the higher number of lung cancer cases avoided under PO 2. 

The 9 public authorities which currently have no limit value for PAHs would also benefit from all 
POs  in  terms  of  avoided  costs  linked  to  the  process  of  setting  a  binding  limit  value  for  PAHs. 
Setting  a  limit  value  requires  resources  for  carrying  out  the  necessary  analysis,  including  impact 
assessments.  Under  all  POs,  the  costs  related  to  the  preparatory  work  would  be  borne  at  EU 

141 RPA (2024), op. cit., according to exposure data, team leaders, which stand at a distance from a fire, are the ones at 
risk  of  airborne  exposure  to  PAH  because  they  do  not  wear  respiratory  protective  equipment.  For  this  impact 
assessment, it was assumed that 10% of a total of 4,385,061 firefighters are team leaders. The rest of firefighters  are 
supposed  to  wear  self-contained  breathing  apparatus  with  an  independent  supply  of  oxygen  and  are  therefore  not 
considered to be exposed to airborne PAHs.  
142 RPA (2024), op. cit., section 7.4.1 of the PAHs report. 

50 

 
 
level, representing cost savings for public authorities of €900,000 in total. In addition, those public 
authorities with a higher existing national limit value than the values proposed in the different POs 
will also benefit from the analysis carried out at EU level. Those Member States will save between 
€0.7 (PO 4) and €0.9 million (PO 2).  

Overall, the costs to public authorities are expected to significantly outweigh the benefits under PO 
2.  Under  POs  3  and  5,  the  costs  to  public  authorities  would  also  outweigh  the  benefits,  but  to  a 
lesser extent. Under PO 4, public authorities would save money over the reference period.  

With  regard  to  the  impacts  on  specific  Member  States,  based  on  the  distribution  of  companies 
within Member States143, at PO 2 the effects from closure of coking plants (100% discontinuation) 
may  be  most  felt  in  Czechia  (22%  of  plants),  followed  by  Poland  (19%),  Romania  (17%)  and 
Greece  and  Spain  (both  11%).  A  similar  pattern  should  be  observed  at  the  70  ng/m3  with  45% 
closures.  

A high level of discontinuations in coal tar plants (62% at PO 2 and 34% at PO 3) may be the most 
disruptive  in  Spain,  followed  by  the  remainder  of  Member  States  with  plants:  Belgium,  Czechia, 
Denmark, Germany and  Poland. The outputs from  this sector however feed into many industries, 
therefore  industries  that  are  related  to  coal  tar  distillation  plants  will  be  negatively  affected, 
regardless of the Member State in which the plants are located.  

In casting of metals, up to 2% discontinuations are predicted at PO 2, which will affect Czechia and 
Italy the most. 

The discontinuations  in graphite and carbon electrode manufacturers  at  the  PO 2 and PO 3 (44% 
and 16% discontinuations, respectively), may be felt mostly in France (25%), Poland and Germany 
(both 20%), Spain and Austria (both 10%). 

Among those Member States identified above, Germany has an existing limit corresponding to PO 
3. Therefore, the impact on businesses operating in Germany should be limited. All other Member 
States have a limit value higher even higher than PO 4 (see annex 6 for more details) or have no 
limit value (Italy and Belgium).    

It also means that the expected reduction in discontinuation from the transitional value provided by 
PO 5 will also more benefit to the Member States identified above.  

These impacts on specific Member States should be treated with caution as it also depends on the 
RMMs  currently  in  place  in  each  company.  In  the  absence  of  such  specific  data,  only  the 
distribution of companies among Member States could be used.  

(e)  Impacts on digitalisation   

By  leading  to  discontinuations  in  key  sectors  contributing  to  the  production  of  semiconductors 
(e.g.in  particular  other  non-ferrous  metallurgy144  and  graphite  and  carbon  electrode 
manufacture145), PO 2 might hinder the digital transition of the EU, including the target under the 

143 The distribution of companies among Member States is based on Eurostat data or date provided by industry.  
144 Silicon metal, which is manufactured by businesses operating in other non-ferrous metallurgy sector, is used to make 
high purity silicon, which ultimately makes wafers. 
145 Speciality graphite and graphene are used in semiconductors.  

51 

 
 
Chips  Act146  to  double  the  production  share  of  semiconductors.  6.7%  and  0.4%  of  businesses 
operating  in  other  non-ferrous  metallurgy  and  graphite  and  carbon  electrode  manufacture  are 
estimated  to  be  at  risk  of  discontinuing,  respectively.  When  only  considering  the  share  of 
companies using cobalt, it is about 44% of businesses that are at such a risk, for both sectors. In the 
absence of sufficient data, this impact could not be quantified.  

PO 3 would also cause discontinuations in these two sectors, but on a lesser scale (8.8% and 16.2% 
of businesses using cobalt and operating in other non-ferrous metallurgy and graphite and carbon 
electrode manufacture, respectively). With its transitional value, PO 5 would  mitigate this impact 
on  digitalisation  as  businesses  operating  in  both  sectors  would  have  more  time  to  plan  their 
investments  and  find  alternative  RMMs,  which 
the  number  of 
discontinuations.  

is  expected 

to  reduce 

PO 4 is not expected to result in impacts on digitalisation.  

(f)  Impacts on EU Strategic Autonomy 

Among those sectors subject to international competitiveness, the structure of two sectors would be 
significantly impacted under PO 2: coking plants (100% of businesses expected to discontinue) and 
steel and iron foundries, ferroalloys (10%). This is likely to lead to greater dependence of the EU 
on its main foreign competitors, hampering its objective of strategic autonomy. 

While the structure of the  steel  and iron foundries, ferroalloys market  should  not  be significantly 
impacted under PO 3, 45% of coking plants  are estimated to discontinue. Therefore, PO 3 would 
also  have  an  impact  on  the  EU’s  strategic  autonomy  as  sectors  dependent  on  coking  plants 
production  (e.g.  coal  tar)  will  be  forced  to  increase  their  imports  from  outside  the  EU.  The 
transitional period provided by in PO 5 is expected to result in less discontinuation, which should 
limit  the  impact  of  a limit  value  at  the level  of  PO  3.  However,  the  magnitude  of  this  mitigation 
cannot be quantified.  

As PO 4 is not expected to entail any discontinuation, the impact on the EU’s strategic autonomy is 
likely to be zero.  

6.2.3.  Environmental impacts  

(a)  Direct impacts on environment   

At all POs, businesses will need to invest in alternative RMMs. To limit the exposure to workers, 
these RMMs  will need to better enclose the different  processes, resulting  in  lower levels  of PAH 
emissions in the air, and therefore positive impacts on the environment. This impact is all the more 
positive  as  some  individual  PAHs  have  been  identified  to  have  persistent,  bio-accumulative  and 
toxic  chemicals  properties,  as  well  as  very  persistent  and  very  bio-accumulative  properties147. 
Although the impact could not be quantified, the number and level of enclosure of the alternative 
RMMs will be proportional to the strictness of the limit values.  

146 OJ L 229, 18.9.2023, p. 1-53  
147 RAC/SEAC (2022), Opinion on an Annex XV dossier proposing restrictions on PAHs in clay targets for shooting, 
available  at:  Revised  restriction  opinion  template  version  11/2015  v4  comments  from  ENV  GROW  RL  SD  SK  SG 
(europa.eu) 

52 

 
 
(b) Indirect impacts on environment   

The  success  of  the  Green  Deal  will  depend  among  others  on  the  availability  of  key  essential 
products. The infrastructure needed to achieve climate neutrality by 2050 relies on metal products, 
such  as  steel,  aluminium  and  silicon.  These  metals  are  essential  for  manufacturing  solar  panels, 
wind  turbine  blades,  electric  vehicles  and  other  sustainable  forms  of  transport,  building  energy 
efficient buildings, etc. Furthermore, some recycling of metals is dependent on carbon and graphite 
electrodes. A disruption in any sectors relevant for the above-mentioned products or metals in the 
EU would therefore compromise the success of the EU Green Deal. 

PO 2 would entail  an estimated high  number of discontinuations in  the following  sectors:  coking 
plants  (100%)  and  steel  and  iron  foundries,  ferroalloys  (10%).  Furthermore,  some  sectors  are 
composed  of  a  few  companies  using  cobalt  for  their  production.  If  PO  2  would  not  significantly 
impact these sectors as a whole, it would significantly impact the share of businesses using cobalt: 
coal  tar  distillation  (0.2%  of  the  entire  sector  /  61.9%  of  businesses  using  cobalt  for  their 
production), other non-ferrous metallurgy (6.7% / 44%), graphite and carbon electrode manufacture 
(0.4% / 44%) and manufacture of aluminium (0.2% / 30%). All these discontinuations are expected 
to result in the disruption of essential products for the EU Green Deal.  

PO 3 is also expected to result in discontinuations in the following key sectors: coking plants (45% 
of  the  entire  sector  /  45%  of  businesses  using  cobalt  for  their  production),  other  non-ferrous 
metallurgy  (1.3%  /  8.8%),  coal  tar  distillation  (0.1%  /  33.6%)  and  graphite  and  carbon  electrode 
manufacture  (0.15%  /  16.2%).  While  the  impact  of  PO  3  is  less,  the  significant  share  of 
discontinuations  in  the  coking  plants  sector  could  result  in  disruptions  in  essential  supply  chains, 
hindering the EU Green Deal’s objectives.  

The transitional value provided for by PO 5 would apply to all the above-mentioned sectors and is 
expected to  reduce the number of possible discontinuations. Indeed, businesses would have more 
time to plan their investments or to find innovative RMMs that would allow for complying with the 
final limit value of PO 5 (which is equivalent to PO 3). Therefore, and although it is unquantifiable, 
the impact of PO 5 on the Green Deal should be limited. 

As no discontinuation is expected under PO 4, the impact on the Green Deal should be zero.   

6.3. 

1,4-dioxane  

Each BLV option was set in relation to the OELs based on a function derived in the RAC opinion148 
which establishes a correlation between both. As such, a worker exposed to levels below an OEL 
(e.g.  7.3  mg/m³)  is  assumed  to  be  also  compliant  with  the  corresponding  BLV  (45  mg  HEAA  in 
urine/g  Creatinine).  Therefore,  for  each  policy  option,  the  BLV  is  not  assumed  to  bring  additional 
benefits and adjustment costs than those related to its corresponding OEL. Conversely, BLVs will 
result in  additional monitoring costs as  the procedure is  different  than for monitoring compliance 
with an OEL.  

148  RAC  (2022),  Opinion  on  scientific  evaluation  of  occupational  exposure  limits  for  1,4-dioxane,  available  at: 
686365df-9485-c2ac-b342-289ec306d188 (europa.eu) 

53 

 
 
6.3.1.  Social impacts  

(a)  Impacts on workers’ health 

Only  PO  2  would  result  in  decreased  health  burden  compared  to  the  baseline.  At  this  level,  no 
worker would get ill following exposure to 1,4-dioxane. The monetised benefits resulting from the 
decreased health burden would account for up to €3.2 million over 40 years.  

Endpoint 

  Table 20: number of avoided cases of ill-health and monetised health benefits over 40 years (compared to 
the baseline) 
PO 2 
7.3 mg/m³ & 
45 mg HEAA in urine/g 
Creatinine  

PO3 
20 mg/m³ & 108 mg HEAA in 
urine/g Creatinine 

Kidney effects 
Liver effects 
Local irritation in the nasal 
cavity 
Monetised health benefits (€ 
million – M1 – M2) 
Source: RPA (2024) 

497 (out of 497) 
633 (out of 633) 
4,382 (out of 4,382) 

0 
0 
0 

€ 1.9 – € 3.2 

€ 0 – € 0 

(b) Impacts on employment 

Under PO 2, 6 companies active in  the following three sectors,  with  140 workers in  total, would 
discontinue  (a)  manufacture  of  basic  chemicals,  fertilisers  and  nitrogen  compounds,  plastics  and 
synthetic  rubber  in  primary  forms,  (b)  manufacture  of  paints,  varnishes,  and  similar  coatings, 
printing  ink  and  mastics,  and  (c)  manufacture  of  other  chemical  products.  The  associated  social 
costs resulting from discontinuances would account for €13 million.  

No impact on employment is expected under PO 3. 

6.3.2.  Economic impacts  

(a)  Impacts on businesses, including SMEs  

With  regard  to  adjustment  costs,  PO  2  would  result  in  the  discontinuation  of  5  small-  and  1 
medium-sized enterprises,  active in  the manufacturing  of basic  chemicals, fertilisers and nitrogen 
compounds, plastics and synthetic rubber in primary forms, manufacturing of paints, varnishes, and 
similar coatings, printing ink and mastics, and manufacturing of other chemical products. As shown 
in  table  21,  they  represent  a  very  small  percentage  of  the  enterprises  with  exposed  workers.  No 
discontinuation is expected under PO 3 as the evidence gathered indicates that existing RMMs are 
sufficiently effective to ensure compliance. 

Table 21: number of discontinuations, including per company size and total discontinuation costs 

PO 2 
7.3 mg/m³ & 
45 mg HEAA in 
urine/g Creatinine  

PO3 
20 mg/m³ & 108 mg 
HEAA in urine/g 
Creatinine 

Small companies 

5 (out of 1,716) 

0 

54 

 
 
 
Middle companies 
Large companies  
Total  
Total discontinuation 
costs (in € million) 
Source: RPA (2024) 

1 (out of 63) 
0 (out of 26) 
6 (out of 1,805) 
€ 102.2 

0 
0 
0 
€ 0 

The total costs in additional RMMs for those companies not discontinuing under PO 2 would be of 
€19.2  million  over  40  years,  mainly  supported  by  businesses  operating  in  the  manufacturing  of 
basic chemicals, fertilisers and nitrogen compounds, plastics and synthetic rubber in primary forms, 
manufacturing  of  paints,  varnishes,  and  similar  coatings,  printing  ink  and  mastics,  and 
manufacturing of other chemical products149.  

According  to  estimates150,  companies  would  have  to  make  investments  of  about  €53  million  in 
additional RMMs during the first year to comply with PO 2, in particular small- (€35 million) and 
medium-sized  enterprises  (€  7.6  million).  Recurrent  costs  for  the  same  PO  would  account  for  -
€34.2 million. This negative value is due to the lower recurrent costs linked with the new RMMs, 
compared to the baseline151.   

According to the evidence gathered, the current workers’ exposure levels to 1,4-dioxane are already 
below PO 3. Therefore, no adjustment cost is expected under this option.   

Some companies are expected to check that they are complying with PO 3 (e.g. by being at 10% or 
less  of  the  OEL  as  foreseen  in  the  UNE-EN  689  Standard  on  Workplace  Atmospheres152). 
However,  a  more  significant  number  of  companies  is  expected  to  check  compliance  under  PO  2 
than PO 3.  

Monitoring costs (both for OELs and BLVs153) for PO 2 would account for about €118.8 million 
over  40  years,  of  which  72%  would  be  borne  by  larger  companies.  Under  PO  3,  businesses  are 
expected  to  spend  about  €56.85  million  to  check  compliance  during  the  same  period,  of  which 
about 67% would be at charge of large enterprises.  

Table 22: total estimated monitoring costs in € million over 40 years by policy option and size of company  
Policy options 

PO 2 (7.3 mg/m³ & 45 mg HEAA in 
urine/g Creatinine) 
PO 3 (20 mg/m³ & 108 mg HEAA in 
urine/g Creatinine) 
Source: RPA (2024) 

Small 
12.5 

7.5 

Total costs (€ million) 
Large 
Medium 
86 
20 

11 

38 

Total 
118* 

56.5* 

149 In particular those companies having an industrial use of 1,4-dioxane as a solvent and generation as by-product in 
the chemicals sector. 
150 RPA (2024), op.cit., 1,4-dioxane report, section 7.2.8.  
151 For instance, some sectors with existing reliance upon RMMs with high recurrent costs, such as RPE,  would move 
to RMMs with lesser recurrent costs over the same period, such as closed systems.  
152  Available  at:  UNE  EN  689:2019+AC:2019  Workplace  exposure  -  Measurement  of  exposure  by  inhalation  to 
chemical agents - Strategy for testing compliance with occupational exposure limit values (en-standard.eu) 
153 The CMRD defines the health surveillance as the assessment of an individual worker to determine the state of health 
of that individual, as related to exposure to specific carcinogens, mutagens or reprotoxic substances at work. 

55 

 
   
 
*Rounded 

The administrative costs associated with the monitoring campaigns vary between the POs. Under 
PO 2, companies would need to spend over 40 years about €7,1 million for the organisation of the 
additional monitoring campaigns compared to the baseline, against €4 million under PO 3. Small-
sized enterprises would bear about 70% of the total administrative costs related to the organisation 
of monitoring campaigns over 40 years.    

Table 23: total estimated costs of administrative burden of additional monitoring by policy option and size 
of company over 40 years 

Policy options 

PO 2 
PO 3 
Source: RPA (2024) 

Total costs (€ million) 

Small 
5 
2.95 

Medium 
1.1 
0.6 

Large 
1 
0.45 

Total 
7.1 
4 

In total,  the compliance  costs represent  a  small part of the turnover, or  even  negligible  for PO 3. 
Only under PO 2 would they represent up to 0.47% for small enterprises operating in the chemical 
sector and which has an industrial use of 1,4-dioxane as a solvent and generate it as a by-product,.  

Only  PO  2  would  have  a  positive  impact  on  reducing  the  number  of  ill-health  cases  and  would 
therefore allow businesses to achieve cost savings of €1.3 million over 40 years. These estimates 
only relate to local irritation in the nasal cavity cases, and are therefore likely to be underestimated.  

(b) Impacts on competitiveness  

POs 2 would have a limited impact on cost and price competitiveness with six businesses obliged 
to discontinue, partly or totally, due to the high compliance costs. However, such discontinuations 
would  not  have  any  impacts  on  the  relevant  sectors154,  directly  impacting  0.0003%  of  the 
companies operating in these sectors (6% of the companies with exposed workers to 1,4-dioxane). 
No discontinuation is expected under option 3. Therefore, no impact on consumers, both in terms of 
price or diversity of supply, is expected, including at the most stringent PO.  

With regard to the impact on international competitiveness, the additional costs per company as a 
percentage of turnover are relatively limited. Furthermore, most of the companies impacted by the 
different POs are SMEs, which are usually operating at national scale and are therefore not subject 
to relocation. Therefore, no impact on international competitiveness is expected, even under PO 2.  

Even  at  the  most  stringent  PO  2,  the  share  of  the  compliance  costs  compared  to  average  annual 
R&D  expenditure  would  not  exceed  0.0025%155.  Therefore,  no  impact  on  capacity  to  innovate 
under all POs is expected.  

154 Manufacture of basic chemicals, fertilisers and nitrogen compounds, plastics and synthetic rubber in primary forms, 
manufacture  of  paints,  varnishes,  and  similar  coatings,  printing  ink  and  mastics,  and  manufacture  of  other  chemical 
products. 
155 RPA (2024), op. cit., 1,4-dioxane report, table 8-12 based on Eurostat data.  

56 

 
 
 
 
(c)  Impacts on the single market 

All Member States currently have a binding national limit value above PO 2 or no binding OEL (FI, 
IE and PT have an indicative OEL and the other Member States have a binding OEL). Therefore, 
the  latter  should  reduce  the  regulatory  divergences  between  Member  States,  resulting  in  a  more 
level playing field in the internal market. The impact would be similar under PO 3 as 26 Member 
States would need to revise a more stringent or set a binding limit value for 1,4-dioxane.  

Despite the establishment of a more level playing field, the impact on businesses would be limited 
as a significant share of them are SMEs. Therefore, it is expected that they rather operate at national 
scale than operating in several Member States.   

(d) Impacts on public authorities/Member States   

Under PO 2, all Member States would need to adapt their existing OELs, resulting in transposition 
costs of €810,000. The transposition costs related to OELs for PO 3 would be of €750,000, as a 
lower  number  of  Member  States  would  need  to  adapt  their  existing  limit  values  (25156).    The 
transposition costs are likely to be slightly underestimated as the analysis does not take into account 
the transposition costs for BLVs.  

Avoided costs of ill health for public authorities are expected only under PO 2 as PO 3 would not 
result  in  a  reduced  number  of  ill-health  cases.  Public  authorities  are  expected  to  save  €2  million 
over 40 years.   

Furthermore, Member States are also expected to save money related to the process of revising a 
national  limit value, as  the work  will be done  at  the EU level.  The costs  saved  related to  OELs 
would amount up to between €1.4 (PO 2) and €1.5 million (PO 3). These costs saved are expected 
to be even higher if we also take into account BLVs.  

The total benefits for public authorities would outweigh costs under any POs.  

Under  PO  2,  all  Member  States  would  need  to  change  their  legislation,  which  would  affect  all 
companies  producing  1,4-dioxane  in  these  countries,  especially  businesses  in  Italy,  Germany, 
Spain, France and Greece as they share more than a half of all companies in the EU with workers 
exposed to 1,4-dioxane. There are no companies in Cyprus with workers exposed to 1,4-dioxane. 

(e)  Impacts on digitalisation   

No PO is expected to have an impact on digitalisation.  

6.3.3.  Environmental impacts  

(a)  Direct impacts on environment   

The alternatives RMMs that businesses are expected to put in place under PO 2 are likely to have a 
positive impact on the environment due to the increased enclosure of processes (e.g. closed system 
and partially closed system). This impact could not be quantified. No direct impact under PO 3. 

156 All Member States except LV and NL. 

57 

 
 
(b) Indirect impacts on environment   

No  impact  on  the  green  transition  is  expected  under  PO  3.  PO  2  would  contribute  to  the  zero 
pollution  ambition  for  a  toxic  free  environment  by  better  enclosing  the  different  processes,  as 
described in the section related to the direct impacts on environment.  

6.4.  Welding fumes 

6.4.1.  Social impacts  

(a)  Impacts on workers’ health 

As  mentioned  in  introduction  of  section  6,  PO  2  (inclusion  of  welding  fumes  in  Annex  I)  would 
result in an additional 1% reduction in excess risk157 compared to the current trend158 for five years. 
This  additional  5-years  reduction  in  excess  risk,  which  is  due  to  the  additional  RMMs  in  place,  
would result in more than 1,600 lung cancer cases avoided over 40 years compared to the baseline, 
representing between €997.5 (method 1) and €510 million (method 2) health benefits (see table 24).   

  Table 24: number of avoided cases of ill-health and monetised health benefits over 40 years (compared to 
the baseline) 

Endpoint 

Lung cancer 
Monetised health benefits 
(€ million – M1 – M2) 
Source: RPA (2024) 

PO 2 
Inclusion of welding fumes in Annex I 

1,618 (out of 28,821) 
€ 997.5 – € 510 

(b) Impacts on employment 

In  the  absence  of  data  on  current  exposure  levels  to  welding  fumes,  neither  possible 
discontinuations nor impacts on employment could be quantified. However, as welding processes 
are often the only technically feasible option for joining metals, the impact on discontinuation, and 
therefore on employment, is expected to be limited or negligible.  

6.4.2.  Economic impacts  

(a)  Impacts on businesses, including SMEs  

PO  2  is  expected  to  entail  adjustment  costs  for businesses  between  €67  (method  2159)  and  €156 
million  (method  1160)  over  40  years,  compared  to  the  baseline.  According  to  estimates161, 
businesses  operating  in  specialised  construction  activities  would  bear  the  highest  share  (36%)  of 

157 RPA (2024), op. cit., this 1% reduction in excess risk was validated by feedback from key stakeholders interviewed 
as part of the external study supporting this impact assessment.  
158 -1%, as discussed in section 5.1.5 of this impact assessment.  
159 Based on the assumption that expenditure on fumes extraction and personal protection is 1% higher than under the 
baseline for each of the years to year 40. 
160 Based on the assumption that 1% of the  total workers  exposed to welding fumes  would move from none or poor 
RMMs to adequate RMMs as a result of policy option 2. This 1% was validated during interviews carried out as part of 
the external study with six key stakeholders.  
161 RPA (2024), op. cit., section 6.2.2.7. 

58 

 
 
 
these  adjustment  costs,  followed  by  construction  in  buildings  (about  19%)  and  fabricated  metal 
products  sectors  (12%).  Due  to  insufficient  data,  the  adjustment  costs  could  not  be  distributed 
between one-off and recurrent costs or by company size, and possible discontinuations could not be 
quantified. However, as welding processes are often the only technically feasible option for joining 
metals, the impact on discontinuation, is expected to be limited or negligible. 

However, the evidence gathered indicates that workers’ protection is often weaker in SMEs than in 
larger companies162 and the levels of understanding and awareness may be lower within SMEs163. 
Therefore, the costs for SMEs arising with PO 2 could be higher than for larger companies as they 
would  need  to  invest  in  additional  RMMs  while  having  less  financial  resources  to  devote.  The 
greatest  proportion  of  SMEs  are  in  the  following  sectors:  specialised  construction  activities, 
construction of buildings, fabricated metal products, repair of motor vehicles and motorcycles, and 
repair and installation of machinery and equipment.   

Since  PO  2  is  limited  to  improving  legal  clarity,  no  monitoring  costs  (and  consequently  no 
administrative costs) are expected.  

With its positive impact on workers’ health, PO 2 would allow businesses to achieve cost savings 
of about €4.7 million over 40 years.  

(b) Impacts on competitiveness  

Given the negligible compliance costs for PO2, including compared to the turnover, no impact on 
competitiveness  is  expected.  Consequently,  and  given  the  expected  minimal  impacts  on 
discontinuation, no impact on the open strategic autonomy is expected.  

As more than 99% of businesses undertaking welding activities are SMEs, it is likely that the latter 
will face more difficulties to fully absorb the adjustment costs resulting from PO 2. Consequently, 
some of them could pass on a part of these adjustment costs to consumers directly (e.g. in the repair 
of motor vehicles and motorcycles sector) or indirectly (e.g. specialised construction activities and 
construction of buildings). However, estimates of adjustment cost remain very limited, reducing the 
likelihood  of  price  increases.  Therefore,  the  impact  on  cost  and  price  competitiveness  is 
considered very limited.   

With  regard  to  the  impact  on  international  competitiveness,  some  countries164  already  regulate 
workers’  exposure  to  welding  fumes,  including  by  means  of  limit  values.  Therefore,  PO  2  is  not 
expected to weaken the position of EU-based companies vis-à-vis these countries, even for sectors 
with  a  high  competition  coming  from  Asia  (e.g.  metal  product  manufacturing  and  automotive 
manufacturing  industry).  Furthermore,  since  welding  is  often  undertaken  on  site  (e.g.  welding 
activities  for  construction,  civil  engineering,  and  installation  and  repair  of  equipment  across 
sectors),  these  activities  are  not  impacted  by  competition  coming  from  non-EU  countries. 
Therefore, the impact of PO 2 on the international competitiveness should be negligible.  

According  to  the  evidence  gathered165,  larger  businesses  make  significant  investment  in  R&D, in 
particular  those  operating  in  the  automotive  manufacturing  industry  and  the  manufacturing  of 

162 RPA (2024), op. cit., interviews with stakeholders. 
163 RPA (2024), op. cit., views from a national stakeholder. 
164 Australia, Canada (Quebec), China, India, Norway and South Korea. Japan has also set an OEL for manganese as an 
indicator of welding fumes. 
165 RPA (2024), op. cit. welding fumes report, table 6-33. 

59 

 
 
machinery  and  equipment.  Conversely,  SMEs  active  in  some  sectors  (i.e.  waste  collection, 
treatment  &  disposal,  materials  recovery,  and  manufacture  of  furniture)  have  much  lower  R&D 
expenditure. In the absence of data on which sector would be more impacted by PO 2, the impact 
on capacity to innovate by sector  and company size could  not  be quantified. However,  the total 
adjustment  costs  remain  limited  compared  to  the  total  investments  in  R&D,  and  the  impact  on 
capacity to innovate should therefore be negligible.    

(c)  Impacts on public authorities/Member States   

As an entry in Annex I of the CMRD is less common that the establishment or revision of a limit 
value,  it  was  assumed  that  the  transposition  costs  would  be  higher166  for  those  with  no  current 
entry.  According  to  the  evidence  gathered167,  5  Member  States  have  currently  defined  welding 
fumes as process-generated substances or the equivalent to Annex I process (DE, DK,  FI, LT and 
SK).  For  these  Member  States,  the  transposition  costs  are  assumed  to  be  lower  (€50,000  per 
Member States). In the absence of national entry in Annex I of the CMRD for welding fumes, the 
other Member States would bear the same transposition costs (€ 100,000 per Member State) under 
PO 2. In total, the transposition costs would account for €2,450,000. 

The  reduction  of  the  number  of  lung  cancer  cases  resulting  from  PO  2  would  allow  public 
authorities  to  avoid  costs  (e.g.  treatment  costs)  for  about  €16.5  million.  The  data  available  does 
not allow for an analysis by Member State.  

Overall, the benefits for public authorities would be six times higher than the costs. 

The  evidence  gathered168  did  not  provide  an  identification  of  the  level  of  compliance  with  the 
CMRD  in  individual  Member  States.  It  however  indicated  that  workers  in  Northern  and  Western 
Europe  are  expected  to  be  better  protected  from  welding  fumes  than  in  Southern  and  Eastern 
Europe169. Furthermore, 13 Member States have currently a limit value for welding fumes: AT, BE, 
CY, CZ, DK, ES, FR, DE, IE, LV, LT, NL, and SK.  

The  risk  of  worker  exposure  to  CMRs  is  higher  for  sectors  that  weld  high  alloy  steel  (stainless 
steel) and therefore countries where those sectors are more dominant might be at higher risk.  There 
is higher risk of worker exposure to CMRs in Germany due to there being more high alloy metal 
fabrication undertaken there than in other countries. However, worker protection is generally good 
in Germany, especially for professional welders so this risk is probably well mitigated. 

No detailed analysis of direct impacts on Member States can be derived from this assessment.  

(d) Impacts on digitalisation   

Among  the  sectors  with  exposed  workers  to  welding  fumes  is  the  manufacture  of  computer, 
electronic and optical products, a key sector for the digital transition. This sector is unlikely to be 
impacted by  PO 2 as  businesses  are characterised by a high degree of automation. Therefore, the 

166 For the purpose of the impact assessment,  the transposition costs related to the inclusion of welding fumes would 
account for €100,000, which is two times more expensive than the transposition costs related to the establishment of a 
new OEL.  
167 RPA (2024), op. cit.  
168 RPA (2024), op. cit. 
169 RPA (2024), op. cit., stakeholders consultation  

60 

 
 
workers’  exposure  is  expected  to  be  very  low.  Consequently,  PO  2  should  have  no  impact  on 
digitalisation.   

6.4.3.  Environmental impacts  

(a)  Direct impacts on environment   

PO 2 would result in the installation of additional ventilation systems compared to the baseline. As 
these systems are often equipped with particle filters, the impact on the quantity of welding fumes 
released into the environment should be negligible, as well as the direct impact on environment.  

(b) Indirect impacts on environment   

Potential  releases  of  welding  fumes  via  additional  ventilation  systems  may  result  in  increased 
emissions of heavy metals into the environment. Theoretically, these heavy metals could build up in 
drinking water and bioaccumulate in food chains, negatively impacting some objectives of the EU 
green deal (e.g. designing a fair, healthy and environmentally-friendly food system, preserving and 
restoring  ecosystems  and  biodiversity  and  zero  pollution  ambition  for  a  tox-free  environment). 
However, and as described above, the direct impact on the environment is deemed to be negligible 
thanks to the use of particle filters. Therefore, the impact on the EU Green Deal is also considered 
as negligible.   

7.  HOW DO THE OPTIONS COMPARE? 

Having  regard  to  the  assessment  of  impacts  of  the  POs  described  in  section  6,  the  options  are 
compared per substance, based on the criteria of effectiveness, efficiency and coherence. The main 
objective  is  to  balance  health  considerations  against  economic  impacts,  by  identifying  preferred 
POs  that  are  economically  and  technically  feasible,  effectively  protect  a  maximum  number  of 
workers and are coherent with the relevant key objectives of the EU. For the purpose of comparing 
the POs, some indicators have been identified for each criteria. 

With regard to the effectiveness, the options are compared from the perspective of the prevention of 
deaths  and  other  adverse  health  effects,  their  contribution  towards  a  better  level  playing  field 
through  more  harmonised  rules,  and  their  consistency  with  the  recommendations  of  the  ACSH. 
Regarding  the  last  indicator,  it  is  assumed  that  the  PO  unanimously  recommended  by  the  ACSH 
will ensure effective implementation on the ground, as both employers and workers support it. In 
particular, POs below the limit values recommended by the ACSH might not be fully implemented 
by  businesses  as  they  could  face  economic  or  technical  obstacles  and  would  therefore  not  be 
considered as proportionate by governments, workers and businesses. Therefore, the closer the PO 
is to the ACSH opinion, the greater the positive impact on its effectiveness.   

With  regard  to  the  efficiency,  the  options  are  compared  on  the  basis  of  their  costs/benefits  ratio. 
However, although an option has  not  the best  costs/benefits  ratio, it does  not  automatically mean 
that the resulting costs for businesses will be disproportionate. For that reason, other indicators such 
as the costs compared to turnover and the number of discontinuation and job losses are taken into 
account.  Since  the  evidence  gathered  for  welding  fumes  does  not  allow  for  estimating  the  costs 
compared to turnover and the possible discontinuations and job losses, the following criteria were 
taken into consideration: costs/benefits ratio for businesses only, and costs per company.  

With regard to coherence, the options are compared on the basis of their contribution to Europe’s 
Beating Cancer Plan, whose key objective is cancer prevention. Furthermore, the different options 

61 

 
are also  compared based on their possible impact  on some key  objectives of the EU, such  as the 
green transition, the digital transition and the objective of open strategic autonomy.  

Co-dependencies between scores of some variables from different  criteria may exist, in particular 
between  the  number  of  cancer  and  non-cancer  cases  and  the  coherence  with  Europe’s  Beating 
Cancer  Plan.  The  higher  the  number  of  health-related  cases  is  avoided,  the  greater  the  coherence 
with  this Plan. However, this co-dependency is  not  expected to  affect the  choice of the preferred 
option.  

Based  on  the  above  considerations,  POs  are  scored  from  “0”  to  “+++”/“---”  depending  on  the 
direction  of  the  impact.  “+”/“-”  represents  a  small  positive/negative  effect  and  “+++”/“---”  a 
significant  positive/negative  effect  compared  to  the  baseline.  0  means  that  the  option  would 
constitute  a  negligible  deviation  from  the  baseline  scenario.  The  baseline  scenario  is  rated  0.  A 
“+”/”-“  is  in  parenthesis  means  that  it  is  between  0  and  “+”/“-“.      Based  on  this  assessment,  a 
preferred option is identified for all policy areas and then described in Section 8.  

7.1.  Cobalt and its inorganic compounds 

Effectiveness:  PO  2  would  ensure  the  most  effective  protection  of  workers  health,  by  preventing 
about  95% (71 out  of 76) of cancer cases  and 100% of non-cancer  cases (18,517 out  of 18,517), 
which  constitutes  a  significant  positive  impact  compared  to  the  baseline.  PO  3  would  ensure  a 
positive  impact  on  health  protection  by  preventing  about  65%  of  cancer  cases  and  90%  of  non-
cancer cases. Although to a lesser extent, POs 4, 5 and 6 would ensure a certain level of protection 
of workers’ health, (POs 4 and 6: prevention of 30 % of cancer cases and 55% of non-cancer cases / 
PO 5: prevention of 16% of cancer cases and 17% of non-cancer cases).   

Harmonised  limit  values  at  EU  level  would  contribute  to  a  better  level  playing  field  within  the 
single market. Currently, all Member States would be required to adapt their limit values under any 
POs. Therefore, all POs would have a significant positive impact on the level playing field.  

In its opinion, the ACSH recommended PO 6 (corresponding to PO 4 with a transitional period of 6 
years at the level of PO 5). Therefore, it is expected that PO 6 will ensure the best implementation 
on the ground. Although to a lesser extent, PO 4 should also be correctly implemented by a high 
share of businesses as they support this option, subject to a transitional period. POs 2, 3 and 5 are 
not supported by either employers or workers. With this strong opposition, it is expected that their 
implementation on the ground will not be as effective as for POs 6 and 4, which might undermine 
the number of expected avoided cancer cases.  

Efficiency:  POs 2  and 3 would result in  higher (PO 3), or even significantly higher (PO 2) costs 
than benefits, with a C/B ratio of up to 68 and 15, respectively. Costs resulting from POs 4/6 and 
PO 5 would also outweigh benefits, but in less significant proportions, with C/B ratios of 8 and 6, 
respectively. 

For all POs, most of the costs would be borne by businesses. Under PO 2, the costs in additional 
RMMs  compared  to  turnover  may  represent  a  significant  share  for  businesses  operating  in  some 
sectors and result in significant negative impacts compared to the baseline. This is particularly the 
case  for  SMEs  with  costs  representing  up  to  3%  of  their  turnover,  against  up  to  0.25%  for  large 
companies. Under PO 3, small companies would have to invest in  additional RMMs representing 
up  to  1%  of  their  turnover  (against  up  to  0.25%  and  less  than  0.1%  for  medium  and  large 
companies,  respectively),  resulting  in  negative  impacts  for  those  small  companies,  in  particular 
those operating in the manufacture of other porcelain and ceramic products. Under POs 4 and 5, the 
investments in additional RMMs should remain limited for all businesses in view of their turnover, 

62 

 
even for small companies (0.4% and 0.2%, respectively). With its transitional period, PO 6 would 
allow more time for businesses to  find and invest in RMMs that do currently not exist to comply 
with  the  final  limit  value.  This  should  result  in  higher  costs  in  terms  of  additional  RMMs  than 
under PO 4. However, these costs in additional RMMs are also expected to remain much lower than 
under PO 3 and should therefore be below 1%, which can be considered as limited compared to the 
baseline.  

With 1,086 companies, (1,056 SMEs) expected to discontinue, representing about 26,000 job losses 
PO 2 would lead to significant negative impacts compared to the baseline. As a result of PO 3 and 
PO 4, 142  and 57  businesses (mainly SMEs: 139 and 56) are expected  to  discontinue, leading  to 
about  2,800  and  1,124  job  losses.  The  impact  of  both  POs  3  and  4  compared  to  the  baseline  is 
considered  as  negative.  PO  5  would  result  in  much  less  discontinuations  (10,  all  SMEs)  and  job 
losses  (77)  than  the  previous  options.  In  view  of  the  total  number  of  businesses  with  exposed 
workers, the negative impact is limited. Finally,  PO 6  should allow for less discontinuations than 
PO 4 as the transitional period recommended by the ACSH, including businesses, is considered as 
appropriate to allow businesses to proceed with the necessary investments. Therefore, the negative 
impact should also be limited.  

57 businesses (of which 56 SMEs) would still discontinue under PO 4, against 10 enterprises under 
PO  5  (all  SMEs).  These  discontinuations  would  result  in  1,124  and  77  job  losses,  respectively. 
Small  companies  would  need  to  dedicate  on  average  up  to  0.4%  and  0.2%  of  their  turnover  to 
comply  with  PO  4  and  PO  5,  respectively,  which  is  expected  to  be  bearable.  Given  the  higher 
numbers of discontinuations and job losses for PO 4, it is considered as less efficient than PO 5. 

Coherence: By preventing most of the occupational cancer cases related to cobalt and its inorganic 
compounds, PO 2 would significantly contribute to Europe’s Beating Cancer Plan. PO 3 would also 
positively contribute to the objective of this plan, although to a lesser extent. Finally, PO 4/6 and 
PO 5 would allow to prevent about 30% and 16% of the estimated occupational cancer cases related 
to cobalt and its inorganic compounds, which represent a notable or limited impact compared to the 
baseline, respectively.   

PO 2 is expected to have significant negative impacts on the EU Green Deal, in particular on the 
objectives  to  mobilise  industry  for  a  clean  and  circular  economy,  to  accelerate  the  shift  to 
sustainable  and  smart  mobility  and  to  supply  clean,  affordable  and  secure  energy.  Although  to  a 
lesser extent, PO 3 is also expected to negatively impact the capacity of the Green Deal to deliver 
on some of its objectives. None of the other three POs is expected to have a negative impact on the 
EU Green Deal. None of the POs should have an impact on the digital transition. 

When comparing POs against their coherence with EU strategic framework, PO 2 appear to be the 
less  consistent  compared  to  the  baseline.  A  significant  share  of  businesses  operating  in  the  metal 
recovery sector would indeed discontinue. Furthermore, the investments in additional RMMs would 
also  represent  a  high  cost.  These  two  effects  combined  are  expected  to  significantly  impact  the 
strategic autonomy of the EU with regard to cobalt. Under the other POs, the impact should be very 
limited (PO 3) or even negligible (POs 4, 5 and 6).    

There is no expected impact on digitalisation, no matter the PO.  

Preferred option: Based on the above analysis, PO 6 is the most effective and coherent (together 
with  PO  4)  option.  Although  it  is  less  efficient  than  the  baseline  scenario,  the  latter  would  not 
achieve  the  specific  objectives  described  in  section  4,  in  particular  better  protection  of  workers 
through  the  adoption  by  employers  of  appropriate  RMMs  and  improving  the  level  playing  field. 
Although POs 2 and 3 would lead to a higher number of cancer and non-cancer cases avoided, they 

63 

 
are  also  considered  as  unproportionate,  in  particular  by  businesses.  Furthermore,  PO  6  is  more 
slightly efficient than PO 4 as the number of discontinautions and job losses is expected to be lower 
due to the transitional period giving more time to businesses to plan their investments. Therefore, 
PO  6  represents  the  best  balance  between  all  criteria,  is  considered    proportionate  despite  higher 
costs than benefits, and is therefore the preferred option for cobalt and its inorganic compounds.  

Table 25 – Comparative scoring of the policy options for cobalt and its inorganic compounds and 
identification of the preferred option 

PO 2 

PO 3 

PO 4 

PO 5 

PO 6 

Effectiveness  
Number of cancer and non-cancer cases 
avoided  
Contribution towards a better level 
playing field 
Consistency with the recommendation of 
the ACSH 
Total effectiveness  
Efficiency 
Costs/benefits ratio (C/B ratio) 
Costs in RMMs compared to turnover  
Number of discontinuations and job losses 
Total efficiency 
Coherence  
Coherence with Europe’s Beating Cancer 
Plan  
Coherence with other key EU policies 
(EU Green Deal, EU strategic autonomy, 
digital transition)   
Total coherence  

+++ 

+++ 

--- 

+ 

--- 
--- 
--- 
--- 

+++ 

--- 

0 

7.2. 

PAHs 

++ 

+++ 

-- 

+ 

-- 
-- 
-- 
-- 

++ 

-- 

0 

+(+) 

+++ 

++ 

++ 

- 
- 
-- 
-(-) 

+(+) 

0 

+ 

+ 

+++ 

-- 

(+) 

- 
- 
- 
- 

+ 

0 

(+) 

+(+) 

+++ 

+++ 

++(+) 

- 
-(-) 
- 
- 

+(+) 

0 

+ 

Effectiveness:  POs  2,  3  and  5  would  be  equally  effective  in  protecting  workers  from  non-cancer 
diseases, preventing all cases of developmental toxicity and male infertility. However, PO 2 would 
ensure a higher protection of workers from lung cancer, preventing about 88% of cases (141 out of 
160), against 22% of cases under POs 3 and 5. Therefore, PO 2 is expected to result in significant 
positive impacts compared to the baseline and POs 3 and 5 in positive impacts. PO 4 would be far 
less  effective  than  the  other  POs,  preventing  1%  and  20%  of  cancer  and  non-cancer  cases, 
respectively. Therefore, its positive impact is considered as small compared to the baseline.   

POs 2, 3 and 5 would ensure the same limit value between Member States, contributing to the same 
extent to  a more level  playing  field.  PO 4 would also  positively  contribute, but  to  a lesser extent 
since some Member States already have lower national limit values in place.  

With PO 2, there is a risk that some businesses will not correctly implement the limit value on the 
ground,  as  they  alerted  during  the  consultation  procedure  on  the  technical  and  socioeconomic 
difficulties  they would face. This  would be particularly  the case in  companies where workers are 
still exposed to high levels of PAHs. This would therefore hamper the effectiveness of the PO. PO 
3 is more consistent with the ACSH recommendation than POs 2 and 4, as it was recommended by 
the three interest groups, including workers and businesses. However, the lack of transitional value 
for the 9 sectors as recommended by the ACSH could also negatively impact the effectiveness of its 

64 

 
 
 
implementation  on  the  ground,  as  for  PO  4  which  is  not  supported  by  workers.  PO  5  is  fully 
consistent  with  the  recommendation  of  the  ACSH.  Therefore,  it  is  likely  that  all  relevant 
stakeholders, in  particular workers and  businesses,  will correctly comply  with  its associated limit 
value on the ground as they fully support this option.   

Efficiency: PO 2 would entail highly significant costs compared to the benefits, with a C/B ratio of 
between 232 and 675170. Compared to the baseline scenario, the negative impact of PO 2 in terms 
of  C/B  ratio  would  therefore  be  significant.  The  C/B  ratio  for  POs  3/5,  and  PO  4  would  range 
between 31 -154 and 14 – 115, respectively. It is therefore much less than PO 2 but still represent a 
high negative impact compared to the baseline.  

With  PO  2,  86%  of  the  total  costs  (€43.5  billion)  would  be  borne  by  businesses,  and  13.5%  by 
public  authorities.  This  would  represent  €90,000  per  company  and  €7.75  billion  per  public 
authority. Some SMEs would need to dedicate up to 6.3% of their turnover to comply with PO 2, 
which is very significant compared to the baseline. Under PO 3, businesses would bear about 98% 
of the total costs (€3.09 billion), and public authorities 2%. On average, a company would spend 
€10,000  over  40  years,  against  €80,000  for  public  authorities.  Compared  to  PO  2,  the  costs  per 
entity resulting from PO 3 are much more bearable. SMEs operating in the coking sector and coal 
tar distillation  sector, would  have to  dedicate up to  between 2.5%  and  2.9% of their turnover for 
complying  with  PO  3.  Costs  compared  to  turnover  for  companies  operating  in  other  sectors  are 
expected to be much more limited (in most cases, below 0.1%). The costs to businesses incurred by 
PO 5 are expected to be slightly lower (€2.89 billion) than for PO 3 due to the transitional period 
for  businesses  operating  in  some  sectors.  By  extension,  the  costs  compared  to  turnover  are  also 
expected to be slightly lower for those companies subject to the transitional period. Under PO 4, the 
costs  for  businesses,  including  SMEs,  would  not  exceed  0.01%  of  their  turnover,  which  is 
negligible compared to the baseline.  

As a result of PO 2, 3,462 companies (of which 3,358 SMEs) are expected to discontinue, resulting 
in 47,758 job losses, which represent a significant  negative impact in comparison to the baseline. 
For its part, PO 3 would result in 146 discontinuations, mainly SMEs (135), leading to 2,725 job 
losses.  Compared  to  PO  2,  the  negative  impact  of  PO  3  on  the  number  of  discontinuations  is 
therefore much less significant. With its transitional option for 9 sectors, PO 5 is expected to further 
reduce the negative impact  on discontinuations compared to  PO 3. Indeed, the transitional period 
provided  by  PO  5  has  been  considered  as  appropriate  by  the  ACSH,  including  employers’ 
representatives, to mitigate the negative impacts incurred by PO 3. However, in the absence of any 
quantified impacts, a negative scoring was kept. No discontinuation is expected under PO 4. 

Coherence: PO 2 would significantly contribute to Europe’s Beating Cancer Plan when it comes to 
the  prevention  of  occupational  cancer  occurring  from  exposure  to  PAHs  as  it  would  allow  to 
prevent almost 90% of cancer cases. POs 3 and 5 would also positively contribute, but to a lesser 
extent,  by  preventing  20%  of  the  total  cases  estimated  to  occur  over  the  next  40  years.  The 
contribution of PO 4 to Europe’s Beating Cancer Plan is more anecdotal as only 1% of cancer cases 
would be avoided.  

As described in section 6, PO 2 would result in a high number of discontinuations in key sectors for 
the  EU  Green  Deal.  These  discontinuations  are  expected  to  result  in  the  disruption  of  essential 
products  for  the  EU  Green  Deal  such  as  steel,  aluminium  and  silicon  and  in  hampering  the 
objective of circular economy. Consequently, the impact of PO 2 on the EU Green Deal is expected 

170 Depending on the methodology used to assess benefits.  

65 

 
 
to be negative. PO 3 would also negatively impact some sectors, in particular coking plants. While 
the impact of PO 3 is less, the significant share of discontinuations in the coking plants sector could 
result  in  disruptions  in  essential  supply  chains,  hindering  the  EU  Green  Deal’s  objectives.  The 
transitional  period  provided  by  PO  5  would  apply  to  those  sectors  considered  as  key  in  the  EU 
Green Deal. Consequently, the number of expected discontinuations is likely to be lower than under 
PO 3 as businesses would have more time to proceed with the necessary investments and adapt. As 
no discontinuation is expected under PO 4, the impact on the Green Deal should be zero.   

By  leading  to  a  high  number  of  discontinuations  in  some  key  sectors  for  the  production  of 
semiconductors,  PO  2  is  expected  to  have  a  negative  impact  on  the  digital  transition,  potentially 
hindering the objective of doubling the production of semiconductors as targeted by the Chips Act. 
PO 3 could also negatively impact this objective as 8.8% and 16.2% of businesses using cobalt and 
operating  respectively  in  other  non-ferrous  metallurgy  and  graphite  and  carbon  electrode 
manufacture  are  expected  to  discontinue.  With  its  transitional  value,  PO  5  would  mitigate  this 
impact  on  the  Chips  Act  as  businesses  operating  in  both  sectors  by  reducing  the  number  of 
discontinuations. PO 4 is not expected to result in impacts on digitalisation.  

Furthermore, PO 2 is also expected to hamper the EU’s objective to progress towards its strategic 
autonomy.  Indeed, it should  significantly impact the structure of the following two sectors which 
are subject to international competitiveness: coking plants and steel and iron foundries. Therefore, 
the  EU  would  be  more  dependent  to  its  main  foreign  competitors,  hampering  its  objective  of 
strategic autonomy. To a lesser extent, PO 3 should also impact the structure of the steel and iron 
foundries, ferroalloys market. Consequently, sectors dependent on coking plants production will be 
forced to increase their imports from outside the EU. The transitional period provided by in PO 5 is 
expected to result in less discontinuation, which should limit the impact of a limit value at the level 
of PO 3. However, the magnitude of this mitigation cannot be quantified. Therefore, table 26 below 
include  a  negative  scoring  for  the  impact  of  PO  5  on  other  key  EU  policies,  even  if  this  impact 
could be lower. As PO 4 is not expected to entail any discontinuation, the impact on the EU’s Open 
strategic autonomy is likely to be zero.  

Preferred  option:  PO  5  is  the  more  effective  option  (together  with  PO  3)  and  is  also  the  most 
coherent as it contributes to Europe’s Beating Cancer Plan while limiting the impacts on other EU 
policies.  PO  5  (together  with  PO  4)  is  more  efficient  than  the  other  options  except  the  baseline 
scenario.  Despite  that  costs  arising  from  PO  5  outweigh  benefits,  it  allows  (unlike  the  baseline 
scenario) to achieve the specific objectives laid down in section 4, in particular better protection of 
workers through the adoption by employers of appropriate RMMs and improving the level playing 
field.  Its  consistency  with  the  ACSH  recommendation  indicates  that  businesses  are  inclined  to 
favour and implement this option, despite the costs it will generate. As a result, PO 5 constitutes the 
best  balance  between  all  criteria  and  is  considered  as  proportionate  despite  that  its  C/B  ratio  is 
higher than 1.  

Table 26 – Comparative scoring of the policy options for PAHs and identification of the preferred option 

Effectiveness 
Number of cancer and non-cancer cases 
avoided  
Contribution towards a better level 
playing field 
Consistency with the recommendation of 
the ACSH 
Total effectiveness  

PO 2 

PO 3 

PO 4 

PO 5 

++ 

+++ 

++ 

++(+) 

+ 

++ 

-- 

(+) 

++ 

+++ 

+++ 

++(+) 

+++ 

+++ 

--- 

+ 

66 

 
 
Efficiency 
Costs/benefits ratio (C/B ratio) 
Costs compared to turnover  
Number of discontinuations and job losses 
Total efficiency 
Coherence 
Coherence with Europe’s Beating Cancer 
Plan  
Coherence with other key EU policies 
(EU Green Deal, EU strategic autonomy, 
digital transition)   
Total coherence  

--- 
--- 
--- 
--- 

--(-) 
-- 
-- 
-- 

+++ 

+(+) 

--- 

0 

-- 

(-) 

-- 
-(-) 
0 
- 

0 

0 

0 

--(-) 
0 
- 
- 

+(+) 

- 

(+) 

7.3. 

1,4-dioxane 

Effectiveness: PO 2 would have a significant positive health impact as it would allow to prevent all 
ill-health cases (497 kidney effects cases, 633 liver effects cases and 4,382 cases of local irritation 
in the nasal cavity). Conversely, the protection of workers’ health is not expected to get improved 
compared to the baseline under PO 3 and is therefore equivalent to the baseline.  

By ensuring the same limit value within all Member States, PO 2 would ensure the highest positive 
impact on the level playing field. PO 3 would also result in equivalent limit values across the EU, 
which  should  theoretically  contribute  to  a  better  level  playing  field.  However,  as  all  workers  are 
already  exposed  to  levels  below  PO  3,  the  latter  would  not  result  in  additional  investments  in 
RMMs. Therefore, the real impact of PO 3 on the level playing field is considered as zero.  

PO 2 is fully consistent with the recommendations made by the ACSH in its opinion. Therefore, it 
is  expected  that  businesses  and  workers  will  ensure  a  full  implementation  of  these  rules  through 
investments  in  relevant  RMMs.  PO  3  is  not  consistent  with  the  ACSH  opinion.  This  could 
negatively impact its implementation on the ground. However, as PO 3 is not expected to reduce 
the number of ill-health cases, a lack of implementation will not affect its efficiency. Therefore, it is 
considered  that  PO  3  is  equivalent  to  the  baseline  when  comparing  against  the  criterion  of 
consistency with the ACSH opinion.  

Efficiency: the C/B ratio of PO 2 would be between 40 and 53, with total costs amounting to €257 
million. Compared to the baseline, PO 2 is therefore expected to have a significant negative impact. 
The C/B ratio of POs 3 and 4 could not be calculated in the absence of quantified benefits. 

On average, PO 2 would cost €137,000 by company (up to 0.47% of annual turnover). Therefore, 
its negative impact in comparison to the baseline is limited. PO 3 is expected to entail monitoring 
and  administrative  costs  for  businesses,  amounting  in  total  to  €60.5  million.  Consequently,  PO  3 
would represent an average cost per company over 40 years of €34,000. These costs are therefore 
very limited compared to the turnover (less than 0.1%).   

As  a  result  of  PO  2,  6  out  of  the  1,805  businesses  with  exposed  workers  to  1,4-dioxane  would 
discontinue, of which 5 are small- and 1 medium-sized enterprises. In total, 140 workers would lose 
their jobs due to these discontinuations.  Although limited, the impact compared to the baseline is 
still negative. No discontinuation is expected under PO 3. 

Coherence: Neither option will result in less cancer cases. Therefore, the coherence with Europe’s 
Beating Cancer Plan is unchanged compared to the baseline. PO 2 is expected to be coherent with 

67 

 
 
the EU Green Deal due to the increased enclosed of processes, which would contribute to the zero 
pollution ambition for a toxic free environment. Although unquantifiable, this impact is expected to 
be  very  limited  compared  to  the  baseline.  No  additional  impact  on  the  EU  Green  Deal,  the  EU 
Open Strategic Autonomy or the digital transitions is expected under PO 2 and PO 3.  

Preferred option: PO 2 is the only option which would achieve the specific objectives described in 
section  4,  in  particular  better  protection  of  workers  through  the  adoption  by  employers  of 
appropriate  RMMs  and  improving  the  level  playing  field.  Although  in  a  limited  extent,  it  would 
also  contribute  to  the  EU  Green  Deal  by  decreasing  the  emissions  of  1,4-dioxane  in  the 
environment. Although PO 2 is less efficient than the baseline scenario, its greater effectiveness and 
the  support  of  governments,  workers  and  employers’  representatives  within  the  ACSH  justify  its 
costs. Therefore, PO 2 is the preferred option.   

Table 27 – Comparative scoring of the policy options for 1,4-dioxane and identification of the preferred 
option 

Effectiveness 
Number of cancer and non-cancer cases avoided  
Contribution towards a better level playing field 
Consistency with the recommendation of the ACSH 
Total effectiveness  
Efficiency 
Costs/benefits ratio (C/B ratio) 
Costs compared to turnover  
Number of discontinuations and job losses 
Total efficiency 
Coherence 
Coherence with Europe’s Beating Cancer Plan  
Coherence with other key EU policies (EU Green Deal, EU 
strategic autonomy, digital transition)   
Total coherence  

7.4.  Welding fumes 

PO 2 

PO 3 

+++ 
+++ 
+++ 
+++ 

--- 
- 
- 
-(-) 

0 
(+) 

(+) 

0 
0 
0 
0 

NA 
(-) 
0 
(-) 

0 
0 

0 

Effectiveness:  PO  2,  which  would  require  additional  investments  in  RMMs,  would  result  in  a 
decrease of about 5% of the total number of estimated lung cancer cases due to exposure to welding 
fumes. Despite it would be limited to avoid 5% of the cancer cases, it represents about 1,350 lung 
cancer cases, which can be considered as positive compared to the baseline.  

Currently,  only  5  Member  States  have  included  welding  fumes  in  the  scope  of  the  CMRD. 
Consequently, PO 2 is expected to contribute towards a better level playing field for businesses by 
ensuring the same legal clarity about the dangerousness of welding fumes and its inclusion in the 
scope of the CMRD in all Member States. 

In  its  opinion,  the  ACSH  recommended  PO  2,  considering  that  some  stakeholders,  in  particular 
small  companies, might  not  be aware that  the fumes released as  a result of  their welding process 
may contain carcinogens, mutagens or reprotoxicants. As both workers and businesses fully support 
PO 2, it is likely that they will also implement it on the grounds by carrying out risk assessments 
and, where necessary, investing in additional RMMs. This strong support would therefore increase 
the effectiveness of PO 2. 

68 

 
 
 
Efficiency: the C/B ratio for PO 2 is between 0.29 and 0.07, with benefits overweighing costs by up 
to 15 times. In total, PO 2 would cost between €67 and €156 million over 40 years. While almost 
all costs would be solely borne by businesses, in  particular SMEs, PO 2 would mainly  benefit to 
workers  (more  than  95%  of  benefits  are  for  workers  and  their  families).  The  C/B  ratio  for 
businesses only would be between 14 and 33. Although costs outweigh benefits for businesses, the 
costs per company are expected to be very limited considering the large number of companies with 
exposed workers to welding fumes (841,282). 

Coherence:  PO  2  would  be  coherent  with  Europe’s  Beating  Cancer  as  it  would  contribute  to 
prevent  more  than  1,600  lung  cancer  cases  over  40  years  in  comparison  to  the  baseline.  PO  2 
should not have any impact on digitalisation and negligible negative impact on environment and it 
is therefore coherent with the twin transition. Finally, no impact on the EU open strategic autonomy 
was identified under PO 2. 

Preferred option: PO 2 is more effective, efficient and coherent than the baseline scenario. Overall, 
this  option  would  generate  more  benefits  than  costs,  except  when  limiting  the  analysis  to 
businesses. The representatives of the latter within the ACSH are however in favour of this option, 
which should improve workers’ protection, unlike the baseline scenario which would not contribute 
to  the  specific  objectives  laid  down  in  section  4.  Furthermore,  the  costs  per  company  would  be 
limited,  which  would  contribute  to  the  proportionality  of  the  option. Consequently,  and  based  on 
the above analysis, PO 2 is the preferred option.  

Table 28 – Comparative scoring of the policy options for welding fumes and identification of the preferred 
option 

Effectiveness 
Number of cancer cases avoided  
Contribution towards a better level playing field 
Consistency with the recommendation of the ACSH 
Total effectiveness  
Efficiency 
Costs/benefits ratio (C/B ratio) 
Costs/benefits ratio (C/B ratio) for businesses  
Costs per company 
Total efficiency 
Coherence 
Coherence with Europe’s Beating Cancer Plan  
Coherence with other key EU policies (EU Green Deal, EU strategic 
autonomy, digital transition)   
Total coherence  

PO 2 

++ 
+++ 
+++ 
+++ 

+++ 
-- 
(-) 
(+) 

+++ 
0 

+(+) 

8.  PREFERRED OPTION 

8.1. 

Selection of the preferred policy options and analysis of impacts  

Table 29 – preferred policy options, transitional measures and accompanying measures 

Substance 

Preferred policy option 

Cobalt and 
inorganic 

PO 6 

69 

Accompanying 
measures 
Notations 
Dermal and 

 
 
 
 
cobalt 
compounds  

OELs 
10 µg/m³171 / 2.5 µg/m³172 

respiratory 
sensitisation  

Transitional OEL 
20 µg/m³170 / 4.2 µg/m³171  
(until 6 years after entry into force of the Directive) 
PO 5 

PAHs 

Notations 
Skin notation 

OEL 
70 ng/m³173 

Transitional OEL 
140 ng/m³172 
(until 6 years after entry into force of the Directive and 
limited to 9 sectors174) 
PO 2 

OEL 
7.3 mg/m³ (2 ppm175) 

BLV 
45 mg HEAA in urine/g creatinine 
Baseline scenario 
PO 2 

Inclusion of welding fumes in Annex I of the CMRD 

1,4-
dioxane 

Isoprene 
Welding 
fumes  

STEL 
73 mg/m³ (20 ppm) 

Notations 
Skin notation 

NA 
NA 

According  to  the  evidence  gathered176,  all  policy  options  for  one  substance  will  have  no  or 
negligible  effects  on  the  occupational  exposure  to  the  other  substances.  Therefore,  the  overall 
impacts  on workers, businesses,  environment  and digitalisation are expected to  be  the sum of the 
impacts  for  each  substance,  as  well  as  for  benefits  for  public  authorities.  Conversely,  the  overall 
costs on public authorities is expected to be lower than the sum of the impacts as explained below.  

Finally and as explained in section 6, the estimated discontinuations and job losses are subject to 
uncertainty and are likely to be overestimated.  

The selection of the preferred policy option also reflects stakeholders’ preferences, as documented 
in more details in Annex 2 

171 Inhalable fraction 
172 Respirable fraction 
173 Measured as benzo[a]pyrene 
174 (1) steel and iron foundries, which includes ferroalloy manufacturers, (2) aluminium manufacturers, (3) carbon and 
graphite electrode manufacturers, (4) coking plants, (5) coal tar distillation, (6) refractory products manufacturers, (7) 
welding of train tracks, (8) other non-ferrous metallurgical processes, and (9) casting of metals. 
175 The limit values for 1,4-dioxane expressed in parts per million (ppm) are based on the conversion factor of 1 mg/m³ 
= 0.273 ppm as provided by ECHA in its Annex 1 in support of RAC for evaluation of limit values for 1,4-dioxane at 
the workplace, available at: 073d44ca-5ad2-8128-fd15-8c74a4bdb126 (europa.eu).   
176 RPA (2024), op. cit., section 4.1 of each substance-specific reports 

70 

 
 
 
 
 
 
 
 
 
 
 
 
8.1.1.  Overall impacts on workers  

Overall,  the  preferred  options  are  expected  to  prevent  1,676  lung  cancer  cases  and  18,912  non-
cancer  cases177  over  the  reference  period.  These  avoided  ill-health  cases  represent  savings 
amounting  to  up  to  €1.16  billion178.  Along  with  these  benefits,  the  preferred  options  are  also 
expected to result in discontinuations. Without any transitional periods for cobalt and its inorganic 
compounds  and  PAHs,  it  was  estimated  that  about  4,000  workers179  would  have  lost  their  jobs. 
However,  both  policy  options  for  those  two  groups  of  chemicals  have  a  transitional  value  which 
were  strongly  recommended  by  the  ACSH,  including  businesses.  There  transitional  values  are 
provided  for  reducing  the  number  of  discontinuations  by  giving  more  time  to  businesses  to  plan 
their investments  or find RMMs  which would technically allow for complying  with the preferred 
options.  In  the  absence  of  data,  the  impacts  of  the  transitional  measures  for  cobalt  and  inorganic 
cobalt compounds and PAHs could not be reflected in the overall impacts on workers. However, it 
is  expected  that  much  less  than  4,000  workers  would  lose  their  jobs  due  to  discontinuations 
resulting from the preferred options for PAHs and cobalt and its inogarnic compounds.  

Furthermore, although this could not be quantified, and as explained in section 6, it is likely that a 
share of these job losses would be offset by the creation of new jobs linked to the growth of some 
companies absorbing the activity of those discontinuing. Furthermore, given the current low level 
of unemployment in the EU180, it is also likely that workers losing their job due to discontinuation 
would find another job in the short term. This non-quantified effect could be amplified by some EU 
instruments and national labour market policies.   

8.1.2.  Overall impacts on businesses, including SMEs 

The total adjustment costs incurred by the preferred options over 40 years would amount up to €3.3 
billion. In the absence of evidence, it is not possible to break adjustment costs into investments in 
additional RMMs (1st year and recurrent) and discontinuations costs. However, it is expected that 
the  transitional  period  provided  by  the  package  of  preferred  options  for  cobalt  and  its  inorganic 
compounds  and  PAHs  will  result  in  less  discontinuations  compared  to  a  scenario  with  the  same 
limit  values  without  any  transitional  periods,  for  which  209  discontinuations  were  estimated. 
Therefore,  the  discontinuation  costs  should  be  much  less  than  the  €2.6  billion  expected  without 
transitional  period.  As  95%  of  businesses  expected  to  discontinue  in  the  absence  of  transitional 
periods  were  SMEs,  the  inclusion  of  transitional  measures  in  the  package  of  preferred  options 
would mainly benefit to them. As discontinuations are estimated to decrease with this package of 
preferred options, it is also assumed that the investments in additional RMMs should also increase. 
Indeed, businesses escaping discontinuations would invest in RMMs allow them to comply with the 
package of preferred options. The evidence gathered does not allow for a precise quantification of 
the  total  investments  in additional  RMMs.  However,  it  should  be  higher than  €0.8  billion,  which 
represents the total investments of businesses in additional RMMs to comply with the limit values 
without transitional measures.  

177 2,842 restrictive lung disease, 7,363 upper airway irritation, 38 developmental toxicity, 3,157 male infertility, 497 
kidney effects, 633 liver effects and 4,382 local irritation in the nasal cavity.  
178 Application of WTP (willingness to pay) values to each case (= method 1).  
179 In the absence of data for welding fumes, the impact on employment could not be quantified.  
180 6% in the EU in February 2024 according to Eurostat.  

71 

 
 
In addition, businesses will also need to support monitoring and administrative costs amounting for 
about €535 million over 40 years. Overall, the total costs for businesses arising from the preferred 
options amount to approximatively €3.8 billion during the same period.  

Although  the  total  costs  for  businesses  are  significant  compared  to  the  baseline,  they  would  be 
spread  over  a  high  number  of  businesses.  Consequently,  most  of  businesses  would  face  costs 
representing less (and often far less) than 1% of their turnover. Nevertheless, SMEs operating in the 
coking and coal tar distillation sectorswould face higher costs compared to the turnover.  

The impact of these high costs is however expected to be mitigated thanks to the transitional values 
provided by in the package of preferred options, and supported by both the ACSH and employers’ 
organisation  as  part  of  the  social  partners  consultation.  Such  transitional  periods  would  enable 
employers  to  make  the  necessary  investments  in  additional  RMMs  and  to  explore  technical 
possibilities to ensure compliance. To this regard, existing EU programmes (e.g. Horizon Europe) 
might help to develop innovative solutions to protect workers’ health. This will be further specified 
in a recital accompanying the legislative proposal.    

In  addition  to  the  costs,  businesses  will  also  benefit  from  the  package  of  preferred  options.  The 
package of preferred policy options will indeed result in workers being less at risk of occupational 
illness, which would allow businesses to save costs (e.g. reduced productivity, costs of replacement, 
rehabilitation costs and medical costs181). In total, businesses are expected to avoid costs for a total 
of about €7 million.  

With regard to SME, the share of compliance costs compared to turnover or gross operating product 
is higher for SMEs than large companies operating in the same sector. Therefore, they are likely to 
be more impacted by the package of preferred options compared to larger enterprises. Furthermore, 
as  described  in  section  6,  SMEs  are  more  likely  to  experience  discontinuations  than  larger 
companies.  Therefore,  the  transitional  measures  provided  by  in  the  package  of  preferred  options 
will  benefit  more  to  SMEs  than  large  companies.  SMEs  will  have  more  time  to  plan  their 
investments,  which  should  also  reduce  the  number  of  discontinuations  compared  to  the  same 
package  of  options  without  transitional  periods.  The  impact  on  SMEs,  although  higher  than  on 
larger companies, should therefore remain limited. These transitional measures contribute to avoid 
imposing  financial  constraints  in  a  way  which  would  hold  back  the  creation  and  development  of 
SMEs.   

SMEs tests for all substances, in which the effects of the preferred POs on SMEs are analysed, are 
available in Annex 12.  

8.1.3.  Overall impacts on competitiveness 

Coking  plants,  manufacturers  of  refractory  products,  manufacturers  of  graphite  and  carbon 
electrode,  steel  and  iron  foundries  and  ferroalloy  companies,  businesses  operating  in  other  non-
ferrous metallurgy sector and coal fired power plants would need to make investments in additional 
RMMs  from  the  very  beginning  which  would  represent  more  than  10%  of  their  gross  operating 
surplus. As most of these companies (except for graphite and electrode manufacturers) are mainly 
SMEs, they have less capacity to absorb these compliance costs. Furthermore, it cannot be excluded 
that  some  businesses  would  discontinue,  which  would  negatively  impact  the  availability  of 
products, the diversity of supply, and would push prices up for consumers. As explained in section 

181 More information on cost savings for employers is provided in annex 4. 

72 

 
 
6,  the  transitional  periods  for  cobalt  and  its  inorganic  compounds  and  PAHs  provided  in  the 
package  of  preferred  options  are  expected  to  limit  the  number  of  discontinuations  and  give  more 
time to  businesses, in  particular SMEs, to  plan and  make the necessary investments  in  additional 
RMMs.  This  would  improve  businesses’  ability  to  absorb  costs  and  limit  the  number  of 
discontinuations.  As a result, the impact  on consumers dependent  on these sectors  should also  be 
more  limited,  while  remaining  negative.  For  the  other  sectors,  which  represent  a  majority  of 
companies directly concerned by this initiative, the costs compared to turnover or gross operating 
surplus are very limited and these sectors are not expected to face discontinuations. Therefore, the 
impact on these consumers, both in terms of prices or diversity of supply/availability of products, is 
expected to be negligible.  

The package of preferred option might also negatively  impact  the capacity of some businesses to 
innovate. Although for most businesses, compliance costs represent less than 10% or even less than 
1%  of  their  R&D  expenditures,  the  share  is  higher  for  SMEs  operating  in  the  following  sectors: 
coking plants (costs to businesses represent up to 160% of R&D expenditures), soil remediation (up 
to  155%),  welding  of  railroad  track  (up  to  120-135%)  and  other  non-ferrous  metallurgy  (up  to 
53%). Again, the transitional measures provided by in the package of preferred options is expected 
to  mitigate  this  negative  impact  as  businesses  will  have  more  time  to  plan  their  investments. 
Therefore, the impact on R&D expenditures should be overall negligible,  excepted for the sectors 
mentioned  above  which  might  face  more  difficulties  to  maintain  their  investments  and  for  which 
the transitional measures might play an important role. 

With regard to the impact on international competitiveness, sectors such as steel and iron foundries, 
ferroalloys, aluminium manufacturers, other metallurgy, casting of metal and graphite and carbon 
electrode manufacturers already experience pressure from cheaper imports, particularly from Asian 
countries.  Therefore,  additional  operational  costs  arising  from  compliance  costs  could  negatively 
impact  their  competitiveness  against  cheaper  imports  from  outside  the  EU.  Furthermore  and  as 
mentioned  above,  it  cannot  be  ruled  out  that  some  businesses  will  discontinue  as  a  result  of  the 
package  of  preferred  options,  in  particular  coking  plants.  Depending  on  the  number  of 
discontinuations,  downstream  users  dependent  on  the  production  of  coking  plants  could  become 
more  dependent  on  imports  from  outside  of  the  EU.  This  is  particularly  the  case  for  companies 
producing  batteries  storing  energy  produced  by  wind  turbines,  semiconductors  and  electric 
vehicles. All these negative impacts are expected to be mitigated by the introduction of transitional 
measures in the package of preferred options, which should reduce the number of discontinuations 
and  give  more  time  to  businesses  for  proceeding  with  the  necessary  investments.  Overall,  the 
impact  on  international  competitiveness  should  be  negligible,  except  for  those  sectors  mentioned 
above, in particular  coking plants. Transitional measures are therefore important to mitigate these 
negative  impacts,  although  the  evidence  gathered  does  not  allow  for  a  precise  quantification  of 
these effects.   

More details on the impact on competitiveness are available in Annex 5.  

8.1.4.  Overall impacts on public authorities  

Overall, the package of preferred options would cost to public authorities about €66 million over 40 
years, of which more than 95% are related to the adjustment, monitoring and administrative costs 
related to PO 5 for PAHs. These costs aim to ensure that firefighters’ exposure does not exceed the 
level provided by PO 5. On average, it would cost about €80,000 per public authority over 40 years. 

The remaining  5% relates to  transposition costs.  Public authorities will need to  transpose in  their 
national legislations the package of preferred options as soon as the latter are stricter than existing 

73 

 
national  rules.  Since  Member  States  are  expected  to  carry  out  the  transposition  in  one  go,  the 
transposition  costs  described  in  section  6  for  each  substance  will  not  be  cumulative.  Since  no 
Member State currently has a national legislation which is in full compliance with the package of 
preferred options, it is reasonable to assume that Member State will need to dedicate up to €100,000 
(corresponding to the highest transposition costs for welding fumes) for the transposition of the new 
rules.  

The  package  of  preferred  options  would  also  bring  benefits  for  public  authorities,  amounting  in 
total to about €30.4 million, in particular in the form of cost savings (e.g. healthcare cost savings 
due  to  fewer  cancer  and  non-cancer  cases)  amounting  to  €26.65  million.  The  remaining  benefits 
relates to avoided costs of setting limit values following national processes, which would represent 
up to €3.75 million.  

The net costs over 40 years for public authorities would therefore amount to about €35.5 million, of 
which about €15 million would be one-off costs and correspond to investments in RMMs to protect 
firefighters against exposure to PAHs.  

8.1.5.  Overall impacts on green and digital transitions  

The  package  of  preferred  options  would  result  in  an  increasing  enclosure  of  some  processes, 
leading  to  less  release  of  some  hazardous  substances  in  the  environment.  However,  this  direct 
impact on environment is expected to be negligible.  

The package of preferred options might have some negative indirect impacts on the green transition 
ot the digital transition due to discontinuations in key sectors. The assessment performed in section 
6 indicates that the sectors subject to discontinuations and which are key for the green or the digital 
transition  are:  coking  plants,  other  non-ferrous  metallurgy,  coal  tar  distillation  and  graphite  and 
carbon  electrode  manufacture.  These  sectors  play  a  key  role  for  the  development  of  the  circular 
economy,  the  manufacture  of  green  infrastructures  and  the  manufacture  of  semiconductors. 
Therefore, a disruptions in the supply chains might hamper the EU objective to progress toward a 
green and digital transition. However, the risk of discontinuing is expected to be mitigated by the 
transitional  measures  provided  in  the  package  of  preferred  options,  in  particular  the  transitional 
period for PAHs. Consequently, the number of discontinuations in these sectors is expected to be 
limited  and  should  not  disrupt  the  supply  chains  which  are  essential  for  the  green  and  digital 
transition.  Therefore,  the  overall  indirect  impact  on  the  green  and  the  digital  transition  should  be 
limited.  

8.1.6.  Overall impacts on EU Open Strategic Autonomy  

The package of preferred options is  not  expected to  hinder  the recycling of cobalt as critical  raw 
material to ensure an EU Open strategic autonomy. Indeed, the number of discontinuations in metal 
recovery sector is expected to be negligible or even zero and the compliance costs would represent 
a  negligible  share  of  the  turnover.  Nevertheless,  this  package  could  result  in  some  coking  plants 
discontinuing. As a result, those sectors dependent to the production of coking plants (e.g. coal tar) 
might  need  to  import  their  products  from  outside  the  EU.  which  would  hinder  the  EU’s  open 
strategic  autonomy  in  its  objective  of  green  and  digital  transition  as  coal  tar  is  essential  in  the 
production  of  batteries  storing  energy  produced  by  wind  turbines,  semiconductors  and  electric 
vehicles. However, this negative impact should be mitigated by the transitional measures for PAHs 
in  the  package  of  preferred  options,  which  is  expected  to  reduce  the  number  of  possible 
discontinuations  in  the  coking  sector.  No  further  impact  on  EU  Open  Strategic  Autonomy  is 
expected.  

74 

 
8.2. 

Subsidiarity and proportionality  

In view of the available evidence, establishing binding limit values for cobalt and inorganic cobalt 
compounds,  PAHs,  1,4-dioxane,  and  including  welding  fumes  in  Annex  I  of  the  CMRD  would 
result in higher protection of workers’ health. The need for a binding limit value for isoprene is not 
expected  to  bring  benefits  as  no  problem  was  identified.  The  baseline  is  thereforethe  most 
appropriate policy option. The protection of workers’ health against risks arising from exposure to 
these  substances  is  already  covered  by  EU  legislation,  in  particular  by  the  CMRD,  which  can  be 
amended only at EU level. Thepreferred options for cobalt and inorganic cobalt compounds, PAHs, 
1,4-dioxane  and  welding  fumes  build  on  long  and  intensive  discussions  with  all  stakeholders 
(representatives from workers’ associations, employers' associations and governments) that helps to 
ensure that the principles of subsidiarity and proportionality are well respected. 

Updating  the  CMRD  is  an  effective  way  to  ensure  that  preventive  measures  would  be  updated 
accordingly in all Member States, providing a uniform level of minimum requirements designed to 
guarantee a better standard of health and safety  and  thus  minimising the disparities in  health and 
safety  protection  levels  of  workers  between  Member  States.  The  harmonisation  of  minimum 
requirements  would  also  contribute  to  a  level  playing  field  for  operators  in  the  internal  market. 
Updating the CMRD therefore complies with the principle of subsidiarity. 

The proportionality principle is respected as the package of preferred options is limited to revising 
the annexes to the existing CMRD, where necessary, on the basis of the scientific and technical data 
available, as legally requested by Article 16 of the CMRD providing that limit values must be set 
out for all carcinogens, mutagens or reprotoxic substances for which this is possible. Setting limit 
values  for  cobalt  and  its  inorganic  compounds,  PAHs  and  1,4-dioxane  would  contribute  to  the 
effective implementation of the existing employer’s obligations related to the hierarchy of controls 
as  laid  down  in  Articles  4  and  5  of  the  CMRD,  namely  substitution,  use  of  closed  systems  and 
minimisation  of workers’ exposure. The introduction of welding fumes  in Annex I to  the CMRD 
would also ensure a better implementation of the existing obligations laid down in the CMRD. This 
introduction  aims  to  draw  employers’  attention  to  the  possible  dangerousness  of  the  fumes 
generated by their welding process. As provided by the CMRD, employers have to perform a risk 
assessment as soon as an activity is likely to involve a risk of exposure to carcinogens, mutagens or 
reprotoxic  substances.  Therefore,  if  this  risk  assessment  reveals  that  their  welding  fumes  contain 
such hazardous substances, employers will need to take all the necessary RMMs to comply with the 
obligations  laid down in the CMRD, including  the hierarchy of controls  in  Articles 4 and 5.  The 
introduction  of  welding  fumes  does  not  result  in  new  rules  but  aims  to  ensure  a  correct 
implementation of the existing ones, which contributes to the proportionality of the proposal. 

Furthermore, the package of preferred options also offers a certain margin of flexibility to Member 
States for those substances subject to the setting of limit values through the initiative supported by 
the present impact assessment. In accordance with Article 153(4) of the TFEU, setting OELs at the 
EU  level  does  not  prevent  Member  States  from  maintaining  or  introducing  more  stringent 
protective measures (i.e. lower limit values).  

With  regard  to  the  proportionality  of  the  package  of  preferred  options,  the  estimated  costs 
outweigh the monetised benefits for all preferred options, except for welding fumes. However, the 
proportionality of this package does not only depend on the costs/benefits ratio comparison. Other 
factors are taken into consideration to assess the proportionality of the preferred options, such as the 
EU strong commitment to fight against cancer, the stakeholders’ views, the impact on businesses, 
the  existence  of  mitigating  measures  and  the  coherence  with  other  key  EU  policies.  Overall, 
preferred options are considered as proportionate as soon as they contribute to achieve as much as 

75 

 
possible  the  general  objective  of  this  initiative,  while  maintaining  the  costs  at  a  level  which  is 
acceptable for businesses and preserving key priorities of the EU.  

The general objective of this initiative is to ensure to workers the right to a high level of protection 
of their health and safety at work. This objective is in line with the European Pillar of Social Rights, 
which  enshrines  workers’  rights  to  healthy,  safe  and  well-adapted  work  environment,  and  with 
Europe’s  Beating  Cancer  Plan.  Overall,  the  package  of  preferred  options  is  expected  to  prevent 
1,676 lung cancer cases and 18,912 non-cancer disease cases over the next 40 years. 

Some  POs  would  have  allowed  to  make  even  greater  progress  in  the  fight  against  occupational 
cancer. However, these POs would have had significant consequences on businesses, leading to a 
high  number  of  discontinuations  and  job  losses  and  a  substantial  loss  of  competitiveness  for 
European companies operating in certain sectors. They would have negatively impacted the Open 
Strategic  Autonomy  of  the  EU,  as  well  as  its  transition  towards  a  greener  and  more  digital 
European Union. This is in line with what employers’ organisations raised as part of the 2nd phase 
of  the  social  partners  consultation,  namely  that  this  initiative  could  have  more  far-reaching 
consequences  for  the  European  industry,  including  in  terms  of  strategic  autonomy,  relocation  of 
production sites outside of the EU, etc. To this regard, SMEunited called the Commission not to go 
beyond what was agreed by the ACSH, and by extension beyond the package of preferred options 
(except for isoprene). For its part, Business Europe supported the ACSH opinions. 

On the other side, some POs (including the baseline scenario) would be less costly for businesses 
than  the  package  of  preferred  options.  However,  the  positive  effect  of  these  options  on  workers’ 
health would be more limited and would not consequently contribute to the general objective in a 
satisfactory manner.  

The package of preferred options, which is the result of the impact analysis and comparison carried 
out in the previous sections, aims to ensure a balanced approach, i.e. to prevent as much as possible 
industries from closures or severe economic disadvantages while providing an adequate protection 
of the workers at the EU level and being coherent the key objectives of the EU, including Europe’s 
Beating Cancer Plan, the twin transition and the EU strategic autonomy. 

Socio-economic and feasibility factors have been taken into account after intensive discussions with 
all  stakeholders  within  the  ACSH  (representatives  of  workers’  organisations,  representatives  of 
employers’ organisations, and representatives of governments). These discussions were supported 
by evidence gathered through an external study which fully involved Member States, workers and 
businesses,  both  through  data  collection  and  validation.  This  thorough  consultation  of  the  ACSH 
contributed to identify a package of preferred options which is considered as proportionate by those 
that  will  be  impacted  (from  an  economic,  social  and  health  point  of  view)  on  the  ground  and 
coherent with the strategic vision of the EU.  

In particular, the thorough consultation of those stakeholders which will be directly impacted by the 
initiative subject to this impact assessment enabled to identify transitional measures for mitigating 
the  negative  impacts  resulting  from  the  package  of  preferred  options,  in  particular  the  possible 
discontinuations  and  their  consequences  on  the  EU  economy,  the  twin  transition  and  the  EU 
strategic  framework.  With  regard  to  businesses,  the  transitional  periods  were  considered  as 
necessary and appropriate by the social partners and Member States authorities represented in the 
WPC/ACSH  to  give  enough  time  to  businesses  to  adapt.  The  main  objective  of  these  measures 
recommended by stakeholders and retained in  the package of preferred options is  to  significantly 
limit the number of discontinuations. As the number of discontinuations resulting from the package 
of preferred options should be limited thanks to  the transitional measures, the coherence with the 
key objectives  of the EU, including  the twin  transition  and the EU open strategic autonomy,  will 

76 

 
also  be improved. Therefore, these transitional measures largely  contributes to  have a package of 
preferred  options  which  is  proportionate,  namely  that  it  improves  as  much  as  possible  workers’ 
protection, while preserving businesses and supporting the EU’s strategic vision. These transitional 
measures contribute therefore to the proportionality of the package of preferred options by ensuring 
a more appropriate temporal margin for businesses to adapt, where necessary. 

It  is  worth  noting  that  Cobalt  Institute  considers  PO  5  for  cobalt  as  the  optimal  option  to  protect 
workers  and  let  the  cobalt  industry  grow  in  Europe.  These  views,  which  are  based  on  their  own 
impact assessment, are however not consistent with the results of this impact assessment, including 
in  terms  of workers’ protection. Annex 2 describes the main  methodological  differences  between 
both impact assessments. 

Finally,  the  introduction  of  transitional  measures  for  cobalt  and  its  inorganic  compounds  and  for 
PAHs is expected to significantly mitigate the possible negative impacts on businesses and on the 
key  objectives  of  the  EU.  Therefore,  the  package  of  preferred  options  aims  to  ensure  a  balanced 
approach,  i.e.  to  prevent  as  much  as  possible  industries  from  closures  or  severe  economic 
disadvantages  (avoiding  also  that  consequences  are  passed  on  to  consumers)  while  providing  an 
adequate protection of the workers at the EU level and being coherent with the key objectives of the 
EU, including Europe’s Beating Cancer Plan, the twin transition and the EU strategic autonomy. 

8.3.  REFIT (simplification and improved efficiency) 

With  regard  to  the  simplification  and  the  efficiency  improvement  of  the  existing  legislation,  the 
package of preferred option eliminates the need for Member States to conduct their own scientific 
analysis  to  address  the  different  substances.  Employers  also  benefit  from  the  simplification  in 
ensuring legal compliance, particularly those operating in different Member States. 

8.4.  Application of the ‘one in, one out’ approach 

All the administrative costs identified in section 6 relate to monitoring and therefore are exempted 
from the offsetting obligation under the ‘one in, one out’ approach182.  

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

9.1.  Monitoring arrangements 

Progress  towards  achieving  the  objectives  of  the  initiative  will  be  monitored  by  a  series  of  core 
indicators. These and the related data sources are summarised below. 

Table 30 - indicators and monitoring arrangements/data sources 

Specific objective 

Operational 
objective 

Indicators 

Further 
improving 
protection 
workers’ 
from  exposure  to  the 
substances  subject 
to 
this  impact  assessment 

to 

Reductions 
in 
the 
exposure 
identified  CMR 
substances  in  the 
to 
workplace 

Rates of adoption 
improved 
of 
by 
RMM. 
businesses 
and 
increased 

Monitoring arrangements/data sources for 
monitoring indicators 
Data  notified  by  employers  to  the  competent 
national  authorities  as  regards  record  keeping  in 
accordance with CMRD Art. 15;   
Data  submitted  by  Member  States  in  the  national 
the 
implementation 

reports  on  CMRD  on 

182 According to Better Regulation tool #58 EU Standard Cost Model,  inspection on behalf of public authorities (e.g. 
businesses having to monitor working and other conditions, such as those related to occupational safety and health) is 
not subject to offsetting in the context of the ‘one in, one out’ approach.  

77 

 
 
implementation  of  the  directives,  submitted  in 
accordance with Art. 17a of Directive 89/391/EEC. 
Surveys/commissioned  by  EC  and  Member  State 
Authorities. 

Member  State  data  on  ill-health  associated  with 
these CMR substances 

Reports on operations and functioning of scientific 
bodies. 
Commission reports on adoption of revisions. 
Revisions to CMRD. 

The monitoring of this indicator would require the 
comparison of the expected figures on the burden 
of  occupational  ill-health  in  terms  of  economic 
loss and health care costs and the collected figures 
on these matters after the adoption of the revision. 
The productivity loss and health care costs can be 
established  based  on  the  data  on  the  number  of 
cases  of  occupational  ill-health.  The  cases  of 
occupational  ill-health  accounted  for  should  be 
those  related  to  exposure  to  cobalt  and  inorganic 
cobalt 
aromatic 
hydrocarbons  (PAHs),  1,4-dioxane  and  welding 
fumes  
Member State legislation 
Research  studies  commissioned  by  EC  and 
Member State Authorities. 

compounds, 

polycyclic 

through  the  adoption  by 
ap-
employers 
risk 
propriate 
management measures 

of 

levels  which  are 
deemed safe. 

Increasing 
the  clarity 
and effectiveness of the 
CMRD  by  keeping  it 
updated  with  the  latest 
scientific data 

that 
To  ensure 
in-
relevant 
formation 
on 
CMR  substances 
and safe exposure 
are 
levels 
generated 
and 
utilised to in-form 
revisions 
the 
CMRD  

to 

Facilitating 
and 
implementation 
towards  a 
contribute 
playing 
better 
field 
economic 
operators  by  adopting 
minimum require-ments 
at EU level. 

level 
for 

The  reduction  of 
costs  related 
to 
ill-
occupational 
for 
health 
economic 
operators  and  for 
security 
social 
systems 
the 
in 
EU. 

Consistent  limits 
faced 
by 
businesses  across 
the EU 

of 

coverage 
workers 
of 
Numbers 
cases  breaching 
limit  values  and 
actions taken. 
The  reduction  of 
work-related  ill-
health  associated 
with  these  CMR 
substances  in  the 
in 
timing 
EU, 
accordance  with 
latency period 
Bodies, 
processes 
timelines 
established, 
operational  and 
for 
effective 
reviewing 
information  and 
timely 
making 
decisions 
on 
revisions. 

and 

to 

data, 
re-

Revisions 
CMRD 
incorporating 
up-dated 
scientific 
time 
to 
vise/adopt 
Differences 
in 
costs  related  to 
occupational  ill-
for 
health 
economic 
operators 
loss 
productivity) 
social 
and 
security  systems 
in the EU. 

(e.g., 
of 

re-

Number  of  MS 
adopting 
minimum 
quirements 
within  time  set 
by 
revised 
Directive. 
Number  of  MS 
adopting 
standards 
excess 
minimum 
requirements. 
Comparisons  of 

in 
of 

78 

 
 
 
the 
Increasing 
effectiveness  of 
the 
CMRD  by  bringing 
its 
more  clarity  on 
scope  with  regard  to 
welding fumes. 

Improved 
awareness  of  the 
potential  dangers 
welding 
from 
fumes. 

for 

EU  minimum 
require-ments 
those  of 
with 
competing  coun-
tries. 
Member 
State 
transposition  of 
revised CMRD 
Costs 
companies 
operating  across 
Member  States 
(including 
familiarisa-tion 
and 
standardisation.) 
Guidelines 
developed by the 
Member  States, 
awareness-
raising 
campaigns, 
trainings 
other 
activities.  
Number 
proportion 
companies 
encouraging 
practices 
good 
prevent 
that 
cases 
ill-
of 
health associated 
with  the  use  of 
CMR substances 

and 
related-

or 
of 

Questionnaire  sent  to  the  Member  States  on  the 
practical  implementation  of  the  OSH  Directives 
under  the  5-yearly  review  in  accordance  with 
Article 17a of Directive 89/391/EEC. 
Information  from  the  ACSH  and  the  Senior 
Labour Inspectors Committee (SLIC). 

EU-OSHA’s  European  Survey  of  Enterprises  on 
New and Emerging Risks (ESENER). 
Eurofound’s  European  Working  Conditions 
Survey (EWCS). 
Information from the SLIC. 

A  two-stage  compliance  assessment  (transposition  and  conformity  checks)  will  be  carried  out  by 
the  Commission  for  the  transposition  of  the  limit  values.  At  workplace  level,  employers  must 
ensure that the exposure does not go above the limit values set out  in the annexes to the CMRD. 
The  monitoring  of  application  and  enforcement  will  be  undertaken  by  national  authorities, 
particularly  by  the  national  labour  inspectorates.  At  EU  level,  the  Committee  of  Senior  Labour 
Inspectors (SLIC) informs the Commission regarding problems relating to the enforcement of the 
Directive.   

While  collection  of  reliable  data  in  this  area  is  complex,  the  Commission  and  EU-OSHA  are 
actively  working  on  improving  data  quality  and  availability  so  that  the  actual  impacts  of  the 
proposed  initiative  could  be  measured  in  a  more  accurate  way  and  additional  indicators  could  be 
developed in the future.  

79 

 
 
Legislative  action  needs  to  be  followed  up  through  effective  implementation  at  the  workplace. 
Companies have a broad range of tools, information and good practices provided by EU-OSHA in 
the context of a Healthy Workplaces Campaign on dangerous substances183. 

9.2. 

Evaluation arrangements 

In  accordance  with  Article  17a  of  Directive  89/391/EEC,  every  five  years,  Member  States  are 
required  to  submit  a  report  to  the  Commission  on  the  practical  implementation  of  the  EU  OSH 
directives, including Directive 98/24/EC and Directive 2004/37/EC. Using these reports as a basis, 
the  Commission  is  required  to  evaluate  the  implementation  of  the  directives  and,  to  inform  the 
European Parliament, the Council, the European Economic and Social Committee and the ACSH of 
the  results  of  this  exercise  and,  if  necessary,  of  any  initiatives  to  improve  the  operation  of  the 
regulatory  framework.  The  implementation  review  for  the  period  2018-2022  is  currently  ongoing 
and  is  expected  to  be  finalised  by  end  2025.  The  next  implementation  review  will  be  for  the 
periods, 2023-2027 and 2028-2032.  

A key indicator to implementation review of the EU OSH Directives, and therefore the CMRD, is 
the full and correct  transposition by the Member States. On the one hand, Member States should 
notify the Commission  of their transposition of EU Directives  into national  legislation before  the 
deadline  mentioned  in  the  EU  Directive.  Afterwards,  the  Commission  will  perform  a  conformity 
check of the transposition and, in case of inaccuracies in transposition, will request clarifications or 
corrective actions from Member States. 

Until  recently  the  number  of  binding  limit  values  under  CMRD  was  limited,  and  the  above 
implementation  review  tended  not  to  address  specific  chemicals  and  instead  had  a  focus  on  the 
general  requirements  of  the  directives.  Following  successive  legislative  updates,  there  is  now  a 
significant number of limit values. Therefore, for future implementation review under Article 17a 
of  Directive  89/391/EEC,  it  will  be  appropriate  to  consider  developing  a  range  of  indicators  to 
enable  an  assessment  of  the  practical  implementation  of  the  substance-specific  limit  values  to  be 
carried out in the future, together with a continuation of the current practice described above. 

183 The campaign pursued several objectives, including raising awareness on the importance of preventing risks from 
dangerous substances, promoting risk assessment, heightening awareness of risks to exposure to carcinogens at work or 
increasing knowledge of the legislative framework. It was carried out in 2018-2019 

80 

 
 
 
 
 
 
 
ANNEX 1: PROCEDURAL INFORMATION 

1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES 

Lead  DG:  Directorate-General  Employment,  Social  Affairs  and  Inclusion  [Unit  C2  -  Health  and 
Safety at Work, EU-OSHA]. 

Agenda planning: PLAN/2022/1707 

2.  ORGANISATION AND TIMING 

An  Interservice  Steering  Group  (ISG)  was  set  up  to  accompany  the  work  on  the  initiative.  The 
following  DGs  participated  in  this  ISG:  SG,  SJ,  BUDG,  GROW,  EMPL,  ENER,  ENV,  RTD, 
CNECT, EAC, SANTE, JUST, ESTAT and EU-OSHA.  

The  Impact  Assessment  was  discussed  in  the  ISG  on  28  February  (present  DGs:  SG,  EMPL, 
GROW, CNECT, RTD, EU-OSHA) and 12 April 2024 (present DGs: SG, EMPL, GROW, ENV, 
CNECT and EU-OSHA).  

3.  CONSULTATION OF THE RSB 

The draft IAR for the initiative was submitted to the Regulatory Scrutiny Board (RSB) on 24 April 
2024 and the meeting with the RSB took place on 29 May 2024. Following this meeting, the RSB 
gave a negative opinion on 31 May 2024.  

The table below summarises the RSB comments as well as the revisions introduced in response to 
them: 

Table 31 – Summary of RSB comments and explanations on how they were addressed 

What to improve 

How comments were addressed 

the 

explain 

involved)  of 

(1)  The  policy  context  should 
better 
choice, 
(including  the  criteria  applied 
and the main arguments used for 
each  substance  by  the  different 
actors 
the  five 
substances  out  of  the  list  of  28 
substances  to  be  scientifically 
assessed.  Those  explanations 
better 
enable 
should 
in 
the 
understand 
particular  for  substances  with 
limited health impact. 

to 
choices 

A  new  section  1.3  was  added,  outlining  the  procedure 
supporting the revision of the CMRD, in particular the 
important  role played by our key stakeholders, namely 
Member  States  and  Social  Partners.  One  step  of  this 
procedure  relates  to  the  selection  of  chemicals  for 
scientific evaluation.  

Furthermore, section 1.3 also provide information on 
the composition of the ACSH and how it allows for 
covering a large number of sectors and activities. This 
large covering allows for opinions that reflect the 
situation on the ground, including in terms of technical 
and socioeconomic feasibility.  

Furthermore,  we  further  explained  in  section  2.1  how 
these  5  substances  were  selected,  namely  based  on  a 
consultative approach with the members of the WPC, as 
well  as  on  specific  considerations  for  each  substance. 
These  specific  considerations  are  also  presented  in 
section 2.1. 

81 

 
 
The  problem  analysis  should 
better justify the grounds for EU 
action,  taking  into  account  the 
scale  of  the  problem  related  to 
each  substance.  It  should  better 
the 
the  magnitude  of 
assess 
problem  by  presenting 
the 
available  evidence,  especially  in 
dangers 
relation 
to 
and 
from 
coming 
welding fumes. 

isoprene 

health 

Based  on  robust  evidence,  the 
problem drivers should cover, in 
more  detail,  issues  related  to 
existing  employers’  practices, 
such  as  limited  or  uneven  take 
up 
risk  management 
measures,  or  most  modern 
technology. 

of 

A table presenting estimates on the number of workers 
exposed  to  each  substance  in  the  EU,  as  well  as  the 
estimates of current (in 2023) and future (over 40 years) 
burden  disease  per  substance  (including  for  isoprene 
and welding fumes) were included in  section 2.1. This 
table  also  present  the  most  critical  adverse  health 
effects resulting from exposure to each chemical. 

In  addition,  data  related  to  the  costs  of  ill-health  for 
businesses and public administration was also included 
in  section  2.1,  so  it  is  better  aligned  with  figure  2 
outlining the problem tree. As showed in the new table 
2,  most  of  the  costs  of  ill-health  for  businesses  and 
public  authorities  are  due  to  workers’  exposure  to 
welding fumes.  

Furthermore,  the  absence  of  problem  for  isoprene  was 
stressed in section 2.1. The evidence gathered as part of 
this impact assessment indeed showed that workers are 
currently  exposed  to  levels  already  below  the  health-
based occupational limit value derived by RAC. 

Finally, the sub-section 3.2 now discusses the 
magnitude of the problem for all substances, dividing 
them in three categories: 

1.  Substances (cobalt, PAHs and welding fumes) 

which are expected to cause occupational cancer 
over the next 40 years and for which an action is 
necessary in view of Europe's Beating Cancer 
Plan;  

2.  Substances (1,4-dioxane) which are not 

expected to cause cancer but well other diseases 
across the EU over the next 40 years, 
demonstrating the importance to act at EU level; 
and 

3.  Substances (isoprene) which are not expected to 
cause cancer or non-cancer cases over the next 
40 years, and for which an action at EU level 
does not appear necessary. 

to  cancer-causing  substances’, 

Under section 2.2.1 related to  ‘driver 1:  high-exposure 
levels 
is  now 
explained that the current high workers exposure levels 
in  some  sectors  are  the  result  of  insufficient  risk 
management  measures  in  place.  Some  examples  have 
been included to illustrate this link. 

it 

Furthermore, some data related to the current exposure 
concentrations  by  sectors  was  included  in  Annex  6,  in 
addition to the existing data on the number of exposed 
workers by sectors. 

Finally,  a  refence  to  this  Annex  6  was  included  under 

82 

 
The  conclusion  on  the  lack  of 
and 
awareness  of  workers 
employers 
the 
dangerousness of welding fumes 
should  be  also  based  on  robust 
evidence. 

regarding 

dynamic 

investigate  how 

(2) The problem analysis should 
better 
the 
problems  would  evolve  under 
baseline, 
the 
considering 
related 
initiatives  at  EU  and  national 
level 
existing 
obligations  and  exposure  limits. 
The  baseline  scenario  should 

as  well 

other 

as 

section 2.2.1 to draw the attention of the reader on this 
existing data.   

A new paragraph was included under section 2.2.4 
related to ‘driver 4: insufficient awareness of the 
possible dangerousness of welding fumes’ to 
differentiate the dangerousness of welding fumes based 
on the different processes, based on the European 
Chemicals Agency’s (ECHA) scoping study on welding 
fumes.  

Furthermore, a table summarising the welding 
processes, their generated substances, an indication of 
the presence of carcinogens, mutagens or reprotoxic 
substances, and workers exposure was included in 
Annex 6, based on the ECHA scoping study. Section 
2.2.4 refers to this annex 6 when differentiating the 
difference welding processes.  

Section 2.2.4 demonstrates the insufficient awareness of 
the possible dangerousness of welding fumes on the 
basis of the ECHA scoping study and the evidence 
gathered through the consultation of relevant 
stakeholders.  

As mentioned by ECHA in its scoping study, despite the 
fact that welding can be a relatively safe activity if all 
the safety and exposure control measures are in place, it 
remains a prominent concern that welders are at high 
risk from various diseases, including cancers.  

The evidence gathered through the consultation of six 
key stakeholders representing a large number of 
welders in the EU indicates that some employers are 
not aware that welding fumes may contain carcinogens, 
mutagens or reprotoxic substances (such as 
chromium(VI) compounds, nickel compounds, 
cadmium and its inorganic compounds, and beryllium 
and its inorganic compounds) and lead to health risks. 
These employers may therefore ignore to what extent 
exposure to their welding processes and materials used 
can be dangerous for their workers and do not apply the 
measures prescribed by the CMRD to minimise 
workers’ exposure.  

In introduction of section 5.1 related to the baseline, it 
was  specified  that  this  section  describes  how  the 
problem is expected to evolve over 40 years in case of 
no further action is  taken at  EU level.  It  also  specifies 
that  the  baseline  takes  account  of  the  impact  of  the 
implementation of limit values for other substances, the 
effects of forthcoming changes in national legislations, 
the  future  trends  (e.g.  in  use  and  recycling  of  the 
substances, in exposure concentrations due to technical 

83 

 
reflect whether there is expected 
progress  which 
technology 
could  reduce  the  health  dangers 
and 
future 
the  current  and 
worker  safety  and  automation 
the 
in  production 
trends 
industries affected, making good 
use  of  foresight  insights  as  well 
as  information  and  awareness 
the 
taken 
measures 
competent authorities. 

by 

in 

(3)  The  objectives 
section 
should  better  present  what  the 
initiative aims to achieve to have 
a  clearer  and  more  measurable 
view of what success would look 
like.  It  therefore  should  better 
structure  the  specific  objectives, 
present  them  in  more  SMART 
terms  and  link  them  clearly  to 
to  be 
the  problem  drivers 
tackled.  The 
should 
report 
present 
complete 
a  more 
illustration  of  the  intervention 
logic, linking the problems, their 
drivers,  the  policy  objectives, 
and the policy options. 

(4)  The  report  should  clearly 
present upfront and subsequently 
fully analyse and compare all the 
relevant  options,  including  the 

improvements or in exposed workforce), and any other 
relevant insights for the future (e.g. impact of the green 
transition.  

Still  in  section  5.1,  the  description  and  analysis  of  the 
baseline  scenario  was  strengthened.  The  description  of 
the baseline scenarios now refers to the current RMMs 
in  place  in  the  different  sectors  when  discussing  the 
current levels of exposure. A reference to section 2 and 
annex  6  for  more  detailed  information  on  the  current 
RMMs was also added.  

In  addition,  the  baseline  scenarios  now  include  a 
description  of  how  the  ongoing  implementation  of  the 
EU-wide  limit  values  for  some  chemicals  (e.g.  nickel 
compounds,  chromium  VI  compounds  and  cadmium 
and its inorganic compounds) are expected to influence 
the  future  levels  of  exposure  from  the  substances 
subject  to  this  impact  assessment.  Tables  summarizing 
the adjusted concentrations for all relevant sectors were 
also added in annex 6. 

The  description  of  the  baseline  also  better  embed 
strategic  foresight  to  support  the  different  trends, 
including  with  regard  to  the  change  in  the  number  of 
workers exposed.  

Finally,  the  baseline  scenario  better  reflects  whether 
there  is  expected  technology  progress  or  information 
and  awareness  measures  taken  by  the  competent 
authorities which could reduce the health dangers.  

Under  section  4.2,  the  description  of  the  specific 
objectives  was  further  improved  to  have  a  clearer  and 
more measurable view of what success would look like.  

Furthermore,  an  intervention  logic  was  developed  and 
included  in  section  5.2.1  (figure  4).  This  intervention 
logic  links  the  drivers,  the  specific  objectives  and  the 
policy options. This section also includes a description 
of the structure and the logic of the policy options. This 
intervention logic also  contributes to  better present  the 
specific  objectives  of  this  initiative,  as  they  are  now 
directly linked with their relevant drivers.  

A description of each policy option by substances  was 
added  under  section  5.2.2.  This  description  provides  a 
justification  of  the  choice  of  these  specific  options, 
including when they were recommended by the relevant 
the  ECHA’s  Risk 
stakeholders, 

in  particular 

84 

 
transitional options. 

the 
It 
should  better 
individual  options 
the 
corresponding  risk  management 
measures 

link 
and 

It  should  explain  how  adding 
welding fumes to Annex I of the 
Directive  is  an  effective  way  to 
tackle  the  corresponding  health 
issues arising from  certain types 
of  welding  fumes,  better  ensure 
of 
effective 
preventive  measures  and  thus 
deliver 
the  expected  health 
benefits. 

implementation 

Assessment  Committee  (scientific  body)  and 
ACSH.  

the 

Furthermore,  two  new  options  were  added  for  cobalt 
and  its  inorganic  compounds  and  PAHs.  These  new 
options are clearly presented upfront and are now fully 
assessed  in  section  6  and  compared  with  the  other 
options  in  section  7.  They  reflect  a  combination  of  an 
existing  option  and  a  transitional  option.  Both  options 
were recommended by the ACSH and social partners.   

Section  6  now  refers  to  what  extent  businesses  will 
need  to  invest  in  additional  RMMs  for  each  policy 
option.  It  says  that  the  introduction  of  limit  values  for 
cobalt  and  its  inorganic  compounds,  PAHs  and  1,4-
dioxane, and inclusion of welding fumes in Annex 1 of 
the  CMRD,  is  expected  to  reduce  the  occupational 
exposure  to  these  hazardous  substances  as  businesses 
with  exposure  levels  higher  than  the  options  will  have 
to  invest  in  additional  RMMs.  The  extent  of  such 
reduction depends on the current levels of exposure and 
RMMs,  as  well  as  the  projected  future  levels  of 
exposure  in  the  absence  of  any  action  (‘baseline 
scenario’). 

Furthermore, annex 6 now includes data on the required 
additional RMMs by sector for each option. A reference 
to this information was added in section 6 to inform the 
reader about this available data.  

The  introduction  of  welding  fumes  in  Annex  I  to  the 
CMRD  would  ensure  a  better  implementation  of  the 
existing  obligations  laid  down  in  the  CMRD.  This 
introduction  aims  to  draw  employers’  attention  to  the 
possible dangerousness of the fumes generated by their 
welding process. As provided by the CMRD, employers 
have to perform a risk assessment as soon as an activity 
is  likely  to  involve  a  risk  of  exposure  to  carcinogens, 
mutagens or reprotoxic substances. The ECHA scoping 
study  will  support  this  assessment  as  it  provides 
information  on  welding  processes  likely  to  generate 
carcinogens,  mutagens or reprotoxic substances.  If this 
risk assessment reveals that their welding fumes contain 
such hazardous substances, employers will need to take 
all the necessary RMMs to comply with the obligations 
laid  down  in  the  CMRD,  including  the  hierarchy  of 
controls  in  Articles  4  and  5.  The  introduction  of 
welding fumes does not result in new rules but aims to 
ensure  a  correct  implementation  of  the  existing  ones, 
which contributes to the proportionality of the proposal. 
This is now explained in section 5 when presenting the 
policy option for welding fumes.  

85 

 
The  rationale  behind  proposing 
at this point only a single option 
fumes  and  not 
for  welding 
presenting 
setting 
options 
differentiated limit values should 
be better explained. 

better 
should 
report 
The 
elaborate  on 
the  discarded 
options  (including  in  the  main 
report),  in  particular  why  non-
regulatory 
were 
discarded,  such  as  guidance  and 
awareness rising activities. 

options 

A  new  sub-section  5.2.5  was  added  to  introduce  the 
discarded  options,  including  for  welding  fumes.  For 
welding fumes, there is  currently insufficient scientific 
information  to  set  a  limit  value.  Under  this  section,  a 
reference  to  annex  10  was  also  added,  where  more 
lack  of  scientific 
detailed 
information is provided.  

information  on 

this 

Furthermore, a reference to the possible revision of the 
existing  Senior Labour Inspectors Committee’s (SLIC) 
Guidance for National Labour Inspectors on addressing 
health  risks  from  Welding  Fumes  was  included  in 
introduction of section 5.2.1. As mentioned, this update 
improving  awareness  of  the 
would  contribute 
possible dangerousness of welding fumes. However, in 
the  absence  of  specific  information  on  if  and  how  this 
guidance  document  will  be  updated,  the  effects  of  this 
option  could  not  be  assessed.  It  is  also  specified  that 
more  information  on  this  possible  revision  is  available 
in annex 10, under the accompanying measures. 

to 

A  new  sub-section  5.2.5  was  added  to  introduce  the 
discarded options. This new section explains that some 
policy options,  which had been considered at  the early 
stages  of  this  initiative,  have  been  discarded  either 
because  they  are  clearly  disproportionate  (banning  the 
use  of  substances,  directly  adopting  the  most  stringent 
national limit values, less stringent rules for SMEs), or 
unsuitable  to  achieve  the  policy  objectives  (providing 
industry-specific 
information  without 
amending the CMRD, guidance documents), or there is 
insufficient  scientific information  (setting  a limit value 
for welding fumes). 

scientific 

It  should  also  clarify  why  it 
presents  options  for  isoprene  in 
the 
clear 
evidence  on  the  existence  of  a 
problem. 

absence  of 

any 

(5)  The  report  should  present  a 
clearer  and  more  developed 
analysis 
on 
competitiveness  and  SMEs.  It 
should  better  assess  the  impacts 
on competitiveness, for example 

impacts 

of 

A reference to annex was also included in this new sub-
section.  Annex  10  includes  a  description  of  those 
guidance 
discarded 
documents, and the reasons for discarding them.  

including 

options, 

policy 

A  new  section  5.2.4  was  added  to  explain  that  in  the 
absence of problem  for isoprene, no policy option was 
assessed  in  the  main  report  of  this  impact  assessment. 
This  new  section  also  mentions  that  as  the  ACSH 
recommended  a  limit  value  for  isoprene,  and  for  the 
sake  of  transparency,  a  fully-fledged  analysis  of  this 
option was carried out and is available in annex 10.   

The impacts on competitiveness ware further discussed 
for both cobalt and its inorganic compounds and PAHs, 
in particular to identify those sectors which may need to 
pass  on costs to  consumers of be impacted by non-EU 
competitors.  The  analysis  was  reinforced  in  section  6 
when assessing the impacts, and annex 5 related to the 

86 

 
level 

estimated 

by  being  more  nuanced  on  how 
of 
the 
compliance  costs  affects  cost 
competitiveness and by avoiding 
relativising  negative 
impacts 
against  external  circumstances 
and 
ignoring  potential 
cumulative  cost  effects.  Costs 
should  be  assessed  not  only  in 
relation  to  turnover,  but  also  to 
rates of profitability if available. 

thus 

The  report  should  present  in  a 
more  balanced  manner 
the 
expected 
impacts  on  SMEs 
(including  on  competitiveness) 
by  providing  a  comprehensive 
four-step of SME test. 

The  competitiveness  check  in 
Annex 5 should fully reflect  the 
competitiveness 
analysis 
developed in the main report. 

the 

impact  of 

(6)  The  report  should  clearly 
assess 
the 
proposed  measures  on  the  EU’s 
strategic  autonomy  in  critical 
raw materials (e.g., cobalt), steel 
and  substances  vital 
the 
to 
transitions 
digital  and  green 
It 
(graphite,  graphene  etc). 
should  assess  the  risk  that  the 
proposed  measures  will  either 
lead  to  discontinuation  of  EU 
production  thereby  creating  a 
strategic  dependence  or 
to 
offshoring of production leading 
the  EU 
to  de-skilling  of 
workforce. 

competitiveness  check.  Furthermore,  section  8  now 
includes a new sub-section related to the overall impact 
of the package of preferred options on competitiveness. 
The  paragraph  related  to  external  circumstances  was 
also removed from the analysis.   

A  SME  test  for  each  substance  was  developed  and 
included 
in  a  new  annex  12,  following  Better 
Regulations  guidelines.  Furthermore,  SMEs  were 
further  taken  into  consideration  when  assessing  the 
different  impacts  in  section  6  and  comparing  the 
options in section 7.  

The costs/gross operating surplus was used in section to 
assess  and  discuss  the  impacts  on  EU  Strategic 
Autonomy  and  on  environment  for  cobalt  and  its 
inorganic compounds,  and the impact competitiveness 
for PAHs. Furthermore, it was also used to discuss the 
overall  impacts  on  competitiveness  of  the  package  of 
preferred options under section 8.  

A  SME  test  for  each  substance  was  developed  and 
included 
in  a  new  annex  12,  following  Better 
Regulations guidelines. 

In section 8, a new sub-section related to overall impact 
on competitiveness was included. This new sub-section 
is  fully  in  line  with  the  reinforced  analysis  on 
competitiveness  provided 
the 
reinforced  analysis  on  competitiveness  in  annex  5. 
Overall,  the  impact  on  competitiveness,  which  is 
described  in  several  sections  and  annex  of  the  impact 
assessment is better aligned and coherent.  

in  section  6  and 

An  analysis  of  the  impacts  of  the  different  policy 
options  on  the  EU  strategic  autonomy  was  added  in 
section 6, both  for cobalt and its inorganic compounds 
and PAHs.  

Impact  on  EU  strategic  autonomy  was  also  taken  into 
account  in  section  7  when  comparing  the  options.  The 
coherence  of  the  policy  options  was  added  as  criteria 
for comparing the options.  

Finally, a new sub-section was also included in section 
8  to  present  the  overall  impact  of  the  package  of 
preferred options on the EU strategic autonomy.  

87 

 
the 

analysis 

negligible 

(7)  The  report  should  further 
of 
develop 
distributional  effects.  It  should 
a  more  developed 
provide 
impacts  on 
the 
analysis  of 
the 
justify 
to 
consumers 
conclusion  that  the  impact  on 
consumers  should  be  limited  or 
even 
all 
substances.  In  this  respect,  it 
should  provide  evidence  on  the 
capacity of companies to absorb 
significant compliance costs and 
on  the  likelihood  that  the  costs 
may be passed on to consumers. 
It should include the analysis on 
the  likely  impact  on  consumer 
prices  and  a  range  of  goods 
offered on the market.  

for 

the  analysis  of 

The  report  should  also  further 
develop 
the 
impacts, in particular of business 
discontinuation,  on  Member 
States. 

(8)  More  generally,  the  impact 
analysis should bring out clearer 
the  evidence  underpinning  the 
cost  and  benefit  estimates.  It 
should  better  present  the  costs 
and  benefits  for  each  option, 
including 
transitional  options, 
and  should  include  a  summary 
of  this  analysis  in  an  overview 
table.  The  report  should  be 
clearer  on  how 
the 
estimates  are,  what  the  related 
uncertainties  are,  and  how  they 
are 
affected 
stakeholders.  It  should  more 
explicitly  explain  how  industry 
evidence  has  been  taken  into 
account  in  the  analysis  and why 
there  are  significant  differences 
in  the  estimates  of  costs  by  the 
industry and in the report. 

perceived 

robust 

by 

improved, 

significantly 

Under  section  6,  the  assessment  of  the  impact  on 
in 
consumers  has  been 
particular  for  cobalt  and  its  inorganic  compounds  and 
PAHs.  The  analysis  of  these  impacts  takes  better  into 
consideration the particularities of SMEs, which usually 
face  higher  costs  than  larger  companies  and  have  less 
opportunities to absorb incremental costs. It also better 
take into account the structure of the markets. 

Other ratio and data, such as the costs compared to the 
gross operating surplus and the 1st year costs, were also 
used  to  improvement  the  assessment  of  the  impact  on 
consumers, in particular for PAHs.   

In  annex  5  and  section  8,  the  analysis  of  the  overall 
impact  on  consumers  was  also  significantly  improved, 
by  using  the  improved  analysis  in  section  6.  It  also 
better  take  into  account  the  impacts  of  the  transitional 
measures.   

For  each  substance,  we  have  added  information  in 
section  6,  sub-section  renamed  ‘impact  on  public 
authorities/Member States’ on those Member States that 
could  be  more  impacted  due  to  their  high  share  of 
the  relevant  sectors.  The  analysis 
companies 
specifically  mentions  those  Member  States  which  are 
likely  to  be  more  impacted.  This  analysis  is  also 
nuanced,  where  relevant,  with  the  existing  national 
limit values in those Member States.  

in 

In  introduction  of  section  6,  a  summary  of  the 
methodology  used  to  calculate  costs  and  benefits  was 
added.  This  introduction  also  refers  to  the  limitations 
related to discontinuations and also refer to annex 4 for 
information on other limitations. To this regard, a new 
table  65  was  added  in  annex  4  to  outline  the  main 
limitations  or  uncertainties, 
an 
explanation and its likeliness.  

together  with 

Section 6 also includes an analysis of the impacts of the 
two  new  policy  options  providing  for  transitional 
values.  Where  the  evidence  gathered  allows  it,  the 
impacts are quantified or monetised. When the evidence 
gathered  is  insufficient,  the  impacts  are  assessed 
qualitatively. In addition,  a new section 7.4 was added 
in  annex  4  to  present  the  methodology  developed  and 
used to monetise the impacts of the transitional values.  

In Annex 2, a new section 3.6 was included to provide 
information  on  the  existence  of  an  impact  assessment 
carried  out  at  the  request  of  cobalt  institute,  a  global 
trade  association  representing  cobalt  industry.  This 
section  also  describes  in  detail  why  the  impacts 

88 

 
substance 

(9)  The  comparison  of  options 
by 
be 
presented immediately after their 
assessment. 

should 

interaction, 

When  subsequently  identifying 
the preferred package of options, 
the  report  should  provide  clear 
comparison  criteria  and  explain 
their 
relative 
weighting and co-dependency. It 
should  also  explain  how  the 
scoring  of  options  (numbers  of 
pluses and minuses) was carried 
out  and  reflects  the  collected 
evidence 
impacts.  The 
coherence  of  the  options  with 
frameworks, 
legal 
underlying 
including  provisions  on  SMEs 
should be assessed. 

on 

assessed  by  cobalt  institute  differ  from  the  impact 
presented in this impact assessment.  

In introduction of section 6.1 related to the assessment 
of the impacts for cobalt and its inorganic compounds, a 
paragraph was added to explain to what extent the data 
of Cobalt Institute’s impact assessment were used in the 
present impact assessment. It also clearly mentions that 
the  impacts  assessed  for  the  purpose  of  this  impact 
assessment differ from the impacts of Cobalt Institute’s 
impact assessment. It also refers to the new sub-section 
3.6 in annex 2 for more details about the differences in 
terms  of  methodology  between 
impact 
assessment.  

two 

the 

Section  7  was  fully  re-organised  to  ensure  that  the 
comparison  of  options  is  presented  immediately  after 
their assessment.  

their 

Additional  information  was  added  as  introductory  part 
of section 6 to  present  the three criteria  (effectiveness, 
efficiency  and  coherence)  and 
respective 
indicators  for  the  purpose  of  the  comparison.  For 
instance,  with  regard  to  the  effectiveness,  the  options 
are compared from the perspective of the prevention of 
deaths  and  other  adverse  health  effects, 
their 
contribution towards a better level playing field through 
more  harmonised  rules,  and  their  consistency  with  the 
recommendations  of  the  ACSH.  Regarding  the  last 
indicator, 
the  policy  options 
unanimously  recommended  by  the  ACSH  will  ensure 
effective  implementation  on  the  ground,  as  both 
employers and workers support it.    

is  assumed 

that 

it 

Compared  to  the  previous  version  of  the  impact 
assessment, the list of indicators was reworked to avoid 
overlapping  and  better  take  into  account  additional 
analysis performed in section 6, such as impact on EU 
strategic autonomy. With regard to the reworked list of 
indicators,  the  criterion  related  to  coherence  with  EU 
OSH  strategic  framework  was  removed  as  it  overlaps 
with the number of ill health cases avoided.  

With  regard  to  their  relative  weighting,  section  6  now 
clearly  refers  to  the  objective  of  balancing  health 
considerations against economic impacts, by identifying 
preferred  POs  that  are  economically  and  technically 
feasible,  effectively  protect  a  maximum  number  of 
workers  and  are  coherent  with  the  relevant  key 
objectives of the EU. 

In addition, section 6 describes how the POs are ranked 
and when comparing the options, it is specified if the 

89 

 
impact is positive or negative and its order of 
magnitude, so it is aligned with the tables providing the 
score. With regard to the latter, the tables were 
improved so the score for each indicator is also 
provided.  

Finally, the comparison clearly differentiates, where 
relevant, SMEs from larges companies.  

Section  8.2  related  to  subsidiarity  and  proportionality 
was further improved to better justify why the preferred 
options  for  cobalt  and  its  inorganic  compounds  and 
PAHs are proportionate.  

First,  we  now  refer  to  policy  options  that  were  fully 
assessed  in  section  6  and  subject  to  the  comparison 
exercise in section 7.  

Secondly,  this  section  better  refers  to  the  views  of  the 
stakeholders,  in  particular  employers,  workers  and 
Member  States,  which  fully  support the  policy  options 
for  cobalt  and  its  inorganic  compounds,  PAHs,  1,4-
dioxane and welding fumes.  

Thirdly, the section refers to  the thorough consultation 
of the social partners and Member States, which allow 
to  identify  the  need  for  some  transitional  measures. 
These  transitional  measures  ensure  the  proportionality 
of the options, as mentioned at the end of this section.  

that 

the 
the  section  clearly  explains 
Fourthly, 
proportionality  of  the  package  of  preferred  options 
should be seen as the package of options which ensure 
the  best  balanced  approach,  i.e.  to  prevent  as  much  as 
possible  industries  from  closures  or  severe  economic 
disadvantages  while  providing  an  adequate  protection 
of  the  workers  at  the  EU  level  and  being  coherent  the 
key  objectives  of  the  EU,  including  Europe’s  Beating 
Cancer  Plan,  the  twin  transition  and  the  EU  strategic 
autonomy. 

Under  section  7,  the  list  of  indicators  was  reworked, 
including  to  include  new  indicators  such  as  coherence 
with EU strategic autonomy.  

In  addition,  the  comparison  as  such  was  also  further 
developed to better compare the options, including with 
regard  to  the  coherence  with  other  initiatives  such  as 
EU  strategic  autonomy,  EU  Green  Deal  and  digital 
transition.  

This was addressed in section 3, with the addition of the 
numbers and distribution of stakeholders.  

90 

demonstrate 

On  this  basis,  the  report  should 
the 
better 
proportionality  of  the  preferred 
policy  package, 
in  particular 
regarding  cobalt  and  polycyclic 
aromatic hydrocarbons (PAHs). 

The 
other 
coherence  with 
initiatives  aimed  to  build  EU 
strategic  autonomy,  such  as 
Critical  Raw  Materials  and 
Chips should be better reflected. 

(10)  The  report  should  better 
analyse  and  present  various 
stakeholder  views,  with  clear 
differentiation  between  different 
affected  groups.  This  should 

 
apply  to  stakeholder  views  on 
the  magnitude  of  the  problem, 
feasibility  and  usefulness  of  the 
options,  and  significance  of  the 
impacts.  The 
should 
clearly  present  the  numbers  and 
distribution  of  stakeholders  who 
provided their views and analyse 
the 
of 
representativeness 
stakeholder feedback. 

report 

The  analysis  should  make  more 
various 
what 
evident 
the 
think  about 
stakeholders 
preferred policy package. 

The 

(11) 
evaluation 
arrangements  in  the  report  need 
particular 
clarification, 
regarding 
the 
evaluation. 

in 
timing  of 

the 

look 

Monitoring 
evaluation 
and 
section  should  present  what  the 
success  will 
like  and 
set  of  SMART 
propose  a 
indicators  capturing  the  whole 
intervention  logic  (e.g.  take  up 
of risk management measures by 
businesses). 

Section  8.2  provides  the  views  of  BusinessEurope, 
SMEunited  and  ETUC  with  regard  to  the  package  of 
preferred options. 

This  was  addressed  by  introducing  clarification  as 
regards  evaluation  of  transposition  of  the  legislative 
proposal. 

This  was  addressed  by  updating  table  30  related  to 
indicators and monitoring arrangements/data sources, in 
line with RSB requirements  

A  revised  version  of  the  draft  IAR  for  the  initiative  was  re-submitted  to  the  Regulatory  Scrutiny 
Board (RSB) on 2 December 2024 through written consultation. The RSB issued a positive opinion 
with reservations on 19 December 2024.  

The table below summarises the RSB comments as well as the revisions introduced in response to 
them: 

Table 32 – Summary of RSB comments (2nd opinion) and explanations on how they were addressed 

What to improve 

How comments were addressed 

The  rationale  for  intervention 
regarding  welding  fumes  is  not 
demonstrated. 

According  to  estimates,  the  scale  of  the  problem  would  be 
significant as this would result in 28,821 lung cancer cases over 
the  next  40  years  in  case  of  no  EU  action.  Given  the  high 
significance  of  the  problem  compared  to  the  other  substances, 
this  will  be  further  stressed  in  the  impact  assessment  (IA), 
section 2.1.  

A  key  specific  driver  identified  for  welding  fumes-related 
the  possible 
problem 
dangerousness  of  welding  fumes.  This  lack  of  awareness  leads 

insufficient  awareness  of 

the 

is 

91 

 
 
to  insufficient  protective  measures,  including  risk  assessment, 
implementation  of  appropriate  risk  management  measures 
(RMMs) and the information and training of workers. According 
to  the evidence gathered, the improvement of risk management 
measures following the introduction of welding fumes in Annex 
I  to  the  CMRD  will  concern  about  1%  of  workers  involved  in 
welding  activities.  This  was  added  under  section  2.2.4.  Other 
drivers might be considered (see answer “c.”).  

No  publication  that  could  provide  an  indication  of  the  level  of 
compliance  with  the  CMRD  in  individual  Member  States  was 
identified.  This  will  be  clearly  mentioned  in  the  IA,  section 
2.2.1.   

According  to  the  evidence  gathered,  the  lack  of  awareness  is 
considered as an important driver by key stakeholders. Another 
survey carried out with twelve national stakeholders (comprising 
one  company,  two  trade  unions,  three  OSH  experts  and  six 
training/trade  associations)  revealed  that  the  perceived  level  of 
awareness  of  the  presence  of  CMRs  in  welding  fumes  in  their 
members,  employees,  or  students  ranged  widely  from  20%-
100%.  As  a  consequence,  employers  do  not  perform  the 
mandatory  risk  assessment  and  do  not  implement  all  necessary 
measures.  Therefore,  some  workers  might  not  be  adequately 
protected  from  welding  fumes  exposure,  leading  to  possible 
hazardous health effects. The IA will include in its section 2.2.4 
the above evidence to support the driver and its causal link with 
the excessive exposure to welding fumes.  

The  lack  of  inspection  for  non-compliance  with  CMRD  was 
identified  as  a  driver  and  was  discussed  under  a  new  section 
2.2.5 

specific  objective 

regarding  welding 

fumes  was 
The 
reformulated  to  better  link  with  the  cause  of  the  problem, 
namely  the  lack  of  awareness  and  its  possible  consequence  on 
the non-performance of risk assessment. According to Article 3 
(2) of the CMRD, in the case of any activity likely to involve a 
risk  of  exposure  to  carcinogens,  mutagens  or  reprotoxic 
substances, the nature, degree and duration of workers’ exposure 
shall  be  determined  in  order  to  make  it  possible  to  assess  any 
risk  to  the  workers’  health  or  safety  and  to  lay  down  the 
measures to be taken. 

Guidance at EU level already exists:  

•  A European Guidance on welding activities, developed by 
the  SLIC  in  2018,  already  exists  at  EU  level.  Although 
this  guidance  was  developed  for  inspectors,  companies 
can  also  follow  it  to  ensure  they  are  meeting  their 
requirements.  This  guidance 
includes  background 
information  such  as  health  risks,  types  of  welding,  the 
legal  framework  for  regulation,  typical  control  measures, 
health surveillance and key information. It also includes a 

92 

 
welding  fumes  task  sheets  with  specialised  guidance  on 
each  welding  activity  including  approaches  to  control 
welding fumes exposure, illustrative photographs, etc. 
•  The European Welding Association (EWA) has developed 
guidance for different exposure scenarios and operational 
recommended  Risk  Management 
conditions,  with 
Measures (RMMs), with the aim of outlining how metals, 
alloys  and  metallic  articles  and  mixtures  can  be  safely 
welded  with  respect  to  exposure  to  welding  fumes  and 
gases. 

Despite  the  existence  of  guidance  at  EU  level,  the  evidence 
gathered  shows  that  the  problem  persists.  Therefore,  the 
development of a new guidance was not considered as relevant 
to  address  the  problem.  This  was  added  in  section  5.2  and 
Annex 10. 

Due to  the complexity and heterogeneity of the  composition  of 
welding  fumes,  as  well  as 
the  absence  of  harmonised 
classification  in  the  CLP  Regulation,  employers  might  ignore 
that  the  fumes  generated  by  their  welding  activities  might 
reprotoxic  substances. 
include  carcinogens,  mutagens  or 
Consequently,  those  employers  might  not  carry  out  the  risk 
assessment  provided  in  the  CMRD  when  workers  are  or  are 
likely  to  be  exposed  to  carcinogens,  mutagens  or  reprotoxic 
substances as a result of their work. In the absence of such a risk 
assessment, employers are likely not to implement all necessary 
RMMs to comply with the CMRD and adequately protect their 
workers. 

The  evidence  gathered  confirms  that  some  employers  are  not 
aware that welding fumes may contain carcinogens, mutagens or 
reprotoxic  substances  (such  as  chromium  (VI)  compounds, 
nickel  compounds,  cadmium  and  its  inorganic  compounds,  and 
beryllium and its inorganic compounds) and lead to health risks. 
This is further developed in section 2.2.4 

According  to  the  evidence  gathered,  it  is  assumed  that  many 
businesses, in particular larger enterprises, are already applying 
best practices measures and will not need change their practices. 
Following interviews with key stakeholders, it was assumed that 
1%  of  welders  will  improve  their  current  RMMs  following  the 
introduction  of  welding  fumes  in  Annex  I  to  the  CMRD.  This 
will be further reflected under sections 2 and 5.  

Furthermore,  data  related  to  the  current  RMMs  in  different 
sectors as collected through the external study will be added in 
Annex 6. 

The  heterogeneous  character  of  welding  fumes  makes  it  very 
difficult  to  establish a common OEL for all welding processes. 
This  was added in  section 5 and annex 10 when discussing the 
discarded option for welding fumes.    

93 

 
the 

impacts  of 
options. 

The  report  does  not  sufficiently 
the 
analyse 
transitional 
The 
comparison  of  options  and  the 
identification  of  the  preferred 
options  for  each  substance  as 
well  as  the  evidence  base  to 
the  preferred  option 
justify 
combination is not robust. 

The impacts on competitiveness 
and  on  consumers  are  not 
adequately 
The 
recording  of  stakeholder  views 
in the report is partial. 

analysed. 

The revised impact assessment better presents the methodology 
and the evidence for welding fumes in introduction of section 6, 
in particular the methodology to calculate costs and benefits. It 
also  further  discusses  in  a  qualitative  way  the  impacts  on 
employment  and  on  discontinuations.  Given  the  absence  of 
impacts  on  discontinuation,  employment  and  competitiveness, 
no impact on the open strategic autonomy of the EU is expected. 
It is mentioned in section 6.4.2 (b). 

The  expected  effects  of  transitional  options  have  been  further 
described in introduction of section 6, to show how they would 
allow  businesses  to  reduce  costs  and  to  better  plan  their 
investments.  This  addition  allow  to  better  understand  the 
impacts discussed under section 6.4.  

Some  benefits  from  section  1  of  Annex  3  were  updated  in  line 
with the rest of the Annex 3 and the main report. 

An explanation on how the preferred options were chosen, based 
on  the  analysis  provided  in  the  comparison-related  section  was 
added for each substance in section 7.  

The  scores  related  to  (i)  the  number  of  cancer  and  non-cancer 
cases and (ii) the coherence with Europe’s Beating Cancer Plan 
are co-dependent. The higher the number of  cases avoided, the 
greater  the  coherence  with  Europe’s  Beating  Cancer  Plan. 
However,  this  co-dependency  is  not  expected  to  affect  the 
choice  of  the  preferred  option.  The  number  of  cancer  and  non-
cancer cases constitute one single indicator. This was clarified in 
introduction of section 7.  

The closer the policy option is to the ACSH opinion, the greater 
the  positive  impact  on  its  effectiveness.  This  was  made  clearer 
in  the  methodology  for  the  comparison,  in  introduction  of 
section 7. 

The  section  related  to  the  proportionality  of  the  package  of 
preferred options was further improved to stress all factors taken 
into  account  when  carrying  out  the  proportionality  analysis.  In 
addition  to  the  costs/benefits  analysis,  these  factors  are  the  EU 
strong  commitment  to  fight  against  cancer,  the  stakeholders’ 
views,  the  impact  on  businesses,  the  existence  of  mitigating 
measures and the coherence with other key EU policies. 

The analysis was further nuanced so not to give the impression 
that  no  sector  is  expected  to  be  impacted  in  terms  of 
competitiveness. As part of changes brought in the main report, 
the claim that for most businesses, including SMEs, the package 
of  preferred  options  will  not  have  any  impact  on  their 
competitiveness was removed.  

Transitional  measures  are  expected  to  mitigate  the  negative 
impacts  on  businesses,  and  consequently  competitiveness, 
entailed by policy options without transitional options. The text 
now better explains that transitional measures do not mean that 

94 

 
there will be no impact.  

In sections 6 and 8, as well as in Annex 5, the capacity to absorb 
costs,  in  particular  for  SMEs,  and  the  cascading  consequences 
are further discussed. SMEs are in particular unlikely to absorb 
additional  costs,  which  would  result  in  consumers  being 
impacted by raising prices.  

In  sections  6  and  8,  as  well  as  in  Annex  5,  the  impacts  on 
consumers  prices  and  diversity  of  supply  are  further  discussed. 
In particular, the text as revised clearly links those impacts with 
their  causes,  namely  the  incapacity  for  businesses  to  absorb 
additional costs, and the changes in some sectors’ structure due 
to discontinuations (in particular coking plants).   

In  section  2  of  annex  2  direct  links  to  the  individual  ACSH 
opinions  were  added.  We  have  introduced,  where  needed, 
reference to Table related to stakeholders targeted and interests 
represented which is also part of annex 2. Generic formulations 
as regards stakeholders were analysed throughout the document 
and,  where  necessary,  clarifications  were  added.  New 
paragraphs  with  summary  of  stakeholders  consultation  and 
references to Annex 2 were added in  subsection  1.3, section 6, 
subsection 6.1, subsection 8.1,  

Three  paragraphs  were  added  under  new  sub-section  “3.6.  Key 
findings”  and,  as  studies  will  be  made  publicly  available  with 
the  legislative  proposal,  we  introduced  footnote  “RPA  (2024), 
op. cit.” which was already used for same purpose in the IAR. 

4.  EVIDENCE, SOURCES AND QUALITY 

The following Commission reports have fed into the Impact Assessment:  

•  Commission  SWD  Ex-post  evaluation  of  the  European  Union  occupational  safety  and 

health Directives (REFIT evaluation), SWD/2017/010 final 

•  Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the 
European Economic and Social Committee and the Committee of the regions – EU strategic 
framework  on  health  and  safety  at  work  2021-2027  Occupational  safety  and  health  in  a 
changing world of work, COM/2021/323 final 

•  Commission SWD List of substances to be scientifically assessed for the purposes of Article 
18a, third paragraph, of Directive (EU) 2004/37/EC on presenting an action plan to achieve 
new  or  revised  occupational  exposure  limit  values  for  at  least  25  substances,  groups  of 
substances or process-generated substances, SWD (2022) 438 final 

The following expert advice have fed into the Impact Assessment:  

1.  Risk Assessment Committee’s opinions  

The  scientific  expertise  provided  by  ECHA’s  Risk  Assessment  Committee  allowed  for  an 
assessment of health effects of the carcinogens, mutagens or reprotoxic  substances subject to this 
initiative.  

95 

 
 
RAC  prepares  the  opinions  of  ECHA  related  to  the  risks  of  substances  to  human  health  and  the 
environment.  RAC  delivers  among  other  scientific  opinions  on  occupational  exposure  limits 
supporting  Union  regulatory  activity  in  the  field  of  occupational  safety  and  health.  More 
information on about what this committee does can be found on the website of ECHA184. 

RAC  develops  high  quality  comparative  analytical  knowledge  and  ensures  that  Commission 
proposals, decisions and policy relating to the protection of workers’ health and safety are based on 
sound scientific evidence. Based on a Service Level  Agreement (SLA) signed by DG EMPL and 
ECHA, this Committee assists the Commission delivering scientific evaluations, upon request, on 
the  toxicological  profiles  of  each  of  the  selected  priority  chemical  substances  in  relation  to  their 
adverse  health  effects  on  workers.  These  scientific  evaluations  shall,  where  appropriate,  include 
proposals for OELs, biological limit values/biological guidance values and/or notations.  

Members  of  RAC  are  highly  qualified,  specialized,  independent  experts  selected  on  the  basis  of 
objective criteria.  

For the purpose of this initiative, the Commission services have used the relevant chemical agent-
related RAC opinions which are summarised as follows: 

RAC opinion on cobalt and inorganic cobalt compounds  

In its opinion on cobalt and inorganic cobalt compounds, RAC recommended:  

–  OELs  (as  8-hour  TWA)  of  0.5  µg  Co/m³  (respirable  fraction)  and  1  µg  Co/m³  (inhalable 

fraction); and  

–  “skin sensitisation” and “respiratory sensitisation” notations. 

This  opinion,  which  was  adopted  by  consensus  on  1  December  2022,  was  prepared  by  the 
following RAC members: Tiina Santonen and Ruth Moeller. 

RAC opinion on polycyclic aromatic hydrocarbons  

In its opinion on polycyclic aromatic hydrocarbons, RAC recommended: 

–  skin notation. 

RAC  considered  that  benzo-a-pyrene  (BaP)  is  a  marker  substance  for  carcinogenic  PAHs. 
However, RAC did not recommend limit values for BaP because BaP and PAHs containing BaP are 
non-threshold  carcinogens.  Therefore,  no  health-based  OEL  can  be  identified.  Instead,  RAC  the 
following cancer exposure-risk relationship (ERR). 

184 Committee for Risk Assessment - ECHA (europa.eu) 

96 

 
 
This  opinion,  which  was  adopted  by  consensus  on  1  December  2022,  was  prepared  by  the 
following RAC members: Thomas Gebel (with support from Kevin Kohns) and Andrea Hartwig. 

RAC opinion on 1,4-dioxane 

In its opinion on 1,4-dioxane, RAC recommended:  

–  OEL (as 8-hour TWA) of 7.3 mg/m³ (2 ppm); 

–  STEL of 73 mg/m³ (20 ppm); 

–  BLV of 45 mg 2-hydroxyethoxyacetic acid/g creatinine; and   

–  Skin notation. 

This opinion, which was adopted by consensus on 18 March 2022, was prepared by the following 
RAC members: Gerlienke Schuur and Andrea Hartwig. 

RAC opinion on isoprene 

In its opinion on isoprene, RAC recommended:  

–  OEL (as 8-hour TWA) of 8.5 mg/m³ (3 ppm). 

This opinion, which was adopted by consensus on 18 March 2022, was prepared by the following 
RAC members: Andrea Hartwig and Gerlienke Schuur. 

2.  ECHA’s scoping study 

On 17 November,  ECHA delivered  at  the request  of the Commission a  scoping  study  of welding 
fumes  and  fumes  generated  from  other  processes.  This  scoping  study  identifies  the  extent,  range 

97 

 
 
and nature of the key processes, and the substances involved, that lead to the exposure of workers 
from welding fumes+. 

3.  Study performed by external consultants 

The Commission launched a call for tender on 14 July 2022 to carry out a study providing data on 
the social, economic and environmental impacts of a number of POs with regard to the protection 
of workers from the risks arising from the occupational exposure to the five substances subject to 
the initiative.  

The contract started on 4 November 2022 and lasted 21 months. The outcome of this study provides 
the main basis for this impact assessment report and is summarised in the relevant sections of this 
document.   

98 

 
 
 
 
 
ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS REPORT) 

The following consultation activities have been performed:  

Social  Partners  Consultation:  as  required  by  the  TFEU  Article  154,  a  formal  two-stage 
1. 
consultation of the social partners at EU level is required prior to submitting proposals in the social 
policy field. The legislative initiative subject to this consultation on the sixth revision of the CMRD 
tested a new procedure of the two-stage social partners simplified consultation carried out through 
two  ad-hoc  meetings  with  the  participation  of  all  concerned  recognised  social  partners  and  the 
possibility to send written contributions as agreed with cross-sectoral social partners. Such a two-
stage  consultation  has  been  performed  in  2023.  The  first  phase  consultation  was  launched  on  16 
February and ended on 31 March 2023. The first ad-hoc meeting, corresponding to the first phase 
of the social partners consultation to gather the views of European social partners on the proposal, 
was  organised  online  on  16  March  2023.  The  second  phase  consultation  closed  on  21  November 
2023 and confirmed these 5 substances as to be addressed in this initiative. More information about 
these two-stage consultation is provided below in this annex 2. 

2. 
Tripartite  consultation  (ACSH):  the  tripartite  Advisory  Committee  on  Safety  and  Health 
(ACSH),  composed  of  three  full  members  per  Member  State,  representing  national  governments, 
workers’, and employers' organisations, is consulted on regular basis. It gives, considering the input 
of the RAC as well as socio-economic and feasibility factors, opinions which are used to prepare 
the Commission's proposal. More information about this tripartite consultation is provided below in 
this Annex 2.  

3. 
Consultation  of  other  stakeholders  (e.g.,  industry  of  employees’  associations  specifically 
concerned): These  consultations have been carried out  in  the context of the RPA study to  collect 
detailed  information  on  the  potential  impacts  of  establishing  or  revising  OELs  under  the  CMRD 
that  is  not  available  in  published  literature  and  internet  searches.  The  results  of  the  impact 
assessment by eftec (2023) for the Cobalt Institute / REACH Cobalt Consortium have been taken 
into account and used as an input for the market analysis. 

Based  on  the  broad  consultation  of  various  stakeholders,  social  partners  and  Member  States' 
competent authorities, no public consultation on this very technical topic was foreseen, in line with 
the previous amendments of the CMRD. 

1.  SOCIAL PARTNERS CONSULTATION  

1.1.  Results of the 1st phase of the social partners consultation 

During the first stage of social partners consultation, social partners were consulted on the need for, 
and  possible  direction  of,  EU  action.  In  addition  to  the  interventions  made  during  the  16  March 
2023  meeting,  three  recognised  social  partners  sent  written  replies  during  the  first-phase 
consultation, including one workers’ organisation (European Trade Union Confederation – ETUC) 
and  two  employers’  organisations  (SGI  Europe,  SMEunited).  The  first  phase  of  Social  Partners 
consultation closed on 31 March 2023. 

The Commission consulted the Social Partners among others on the establishment and/or revision 
of further binding OELs in Annex III to the CMRD. 

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Commission  identified  a  first  proposed  list  of  priority  substances  for  a  subsequent  amendment 
revision of the CMRD in the first phase consultation document, as follows: 

a)  welding fumes;  
b)  polycyclic aromatic hydrocarbons; 
c)  cobalt and its inorganic compounds;  
d)  1,4-dioxane (CAS no. 123-91-1); and  
e)  isoprene (CAS no. 78-79-5). 

1.1.1.  Workers’ organisations  

During the meeting of 1st stage social partners simplified consultation, workers’ organisations:  

•  expressed support to the simplified consultation procedure of the social partners and to the 

five substances prioritised for the planned initiative;  

•  stressed  the  need  for  taking  into  consideration  the  most  stringent  existing  national  limit 

• 

values when establishing EU-wide OELs; 
 encouraged the Commission to endorse the ACSH opinion on a risk-based approach to set 
OELs. 

Workers’ organisations written response was specific per (group of) substance(s) and complements 
the issues identified by the Commission with the following observations and demands: 

a)  Welding fumes 

Workers’  organisations  are  of  the  opinion  that  welding  fumes  must  be  included  in  Annex  I  of 
CMRD because the International Agency for Research on Cancer (IARC) classified welding fumes 
(and UV radiation) from welding as  “carcinogenic to  humans” (Group 1). Moreover, exposure to 
welding fumes can cause lung  damage and various types of cancer, including  of the lung,  larynx 
and urinary tract. It is estimated that 2 million workers are potentially exposed to welding fumes in 
the EU (mainly welders).  

As the CMRD covers substances meeting the criteria for classification as carcinogenic, mutagenic 
or reprotoxic substances category 1A/1B according to the CLP regulation, workers’ organisations 
demand that it is clarified in the 6th revision of the CMRD that the scope of annex I not only covers 
carcinogens but also includes mutagens and reprotoxic substances.  

Workers’ organisations are also of the opinion that an entry in annex I is obvious and it would be 
just  a  legal  clarification  that  welding  fumes  containing  CMR  substances  are  automatically  in  the 
scope  of  the  Directive.  Therefore,  the  entry  into  annex  I  is  not  enough  and  other  measures  are 
necessary  to  adequately  improve  the  protection  of  the  health  and  safety  of  workers  exposed  to 
welding fumes.  

The scoping study on welding fumes prepared by ECHA has identified several additional measures 
that  could  complement  an  entry  of  welding  fumes  in  annex  I.  The  following  measures  should 
therefore be assessed:  

•  set a generic OEL for inhalable and respirable dust. This means setting a generic OEL for 
inhalable  and  respirable  dust  in  addition  to  the  OEL  requirements  of  the  CMRD  and 
Chemical Agents Directive 98/24/EC (CAD), specific to welding fumes.  

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•  set  mandatory  protective/control  measures  for  welding  techniques  that  lead  to  greater 

emissions of welding fumes or promoting of low emission techniques.  
introduce health surveillance programmes for welders under certain conditions.  

• 

Workers’ organisations are of the opinion that these measures should be included in the legal text as 
soon as possible.  

b)  Polycyclic aromatic hydrocarbons (PAHs) 

After the inclusion of PAHs in CMRD annex I in Directive 2019/130 (second revision of CMRD), 
workers’ organisations find it coherent and necessary to complement the entry into annex I with a 
binding OEL for PAHs in CMRD Annex III (using benzo-a-pyrene (BaP) as a marker for exposure 
to  PAHs).  Workers’  organisations  also  highlighted  that  this  complex  mixture  of  carcinogens  is 
produced  during  the  combustion  and  pyrolysis  of  organic  material  and  is  therefore  “process-
generated”.  Exposure  to  PAHs  can  cause  lung,  skin,  bladder  cancers  as  well  as  leukaemia.  It  is 
estimated that 7 million workers are potentially exposed to PAHs in the EU. 

c)  Cobalt and inorganic cobalt compounds 

Workers’  organisations  support  the  adoption  of  binding  OELs  for  cobalt  and  inorganic  cobalt 
compounds in CMRD annex III. According to them these compounds are used in the metal industry 
to  produce  alloys,  in  the  chemical  industries  as  catalysts  and  for  the  production  of  batteries  for 
electric  vehicles,  tablets  and  smartphones.  Exposure  to  cobalt  and  cobalt  compounds  causes  lung 
cancers,  reproductive  disorders  and  respiratory  effects.  It  is  estimated  that  more  than  80,000 
workers are potentially exposed to these compounds. Particular attention should be paid to workers 
in the waste and recycling sectors as these workers might be increasingly exposed in the future due 
to the energy transition and all measures to counter climate change and environmental degradation 
in the European Green Deal. 

Workers'  organisations  stress  that  several  Member  States  already  have  a  national  OEL  for  cobalt 
and cobalt compounds. However, these OELs vary a lot from one country to another and there is a 
need to adopt an ambitious OEL in annex III CMRD which will help improve the protection of all 
exposed  workers  across  the  EU.  The  adoption  of  an  ambitious  EU  OEL  for  cobalt  and  cobalt 
compounds should be facilitated by the fact that these compounds are generally used in the industry 
with  other  heavy  metals  like  nickel  and  cadmium  compounds  for  which  EU  OELs  have  already 
been adopted under the CMRD. Since the risk management measures are common to many heavy 
metal  compounds  and  they  are  already  in  place  to  comply  with  the  existing  OELs,  no  additional 
protection measures will be needed in many cases. 

d)  1,4-dioxane 

Workers’  organisations  are  of  the  opinion  that  a  binding  OEL  needs  to  be  included  in  annex  III 
CMRD for 1,4-dioxane. According to them, this solvent is used in industrial settings and causes in 
exposed  workers  nasal  and  liver  cancers  on  top  of  respiratory  tract  irritation,  nephrotoxicity  and 
hepatotoxicity. It is estimated that more than 35,000 workers are potentially exposed to 1,4-dioxane 
in the EU. 

According  to  workers’  organisations,  most  Member  States  already  have  a  national  OEL  for  1,4-
dioxane since an indicative OEL was adopted for this solvent in the CAD. However, the national 
OELs  vary  a  lot  from  one  country  to  another  with  some  Member  States  having  a  national  OEL 
much more protective compared to the current EU indicative OEL. 

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Workers’ organisations would like to point out that for OEL setting what is feasible in one Member 
State is also feasible in the other Member States and therefore expects the future EU binding OEL 
on 1,4-dioxane to be at least as protective as the lowest national OEL already in place in the EU. 

e)  Isoprene  

Workers’  organisations  support  the  adoption  of  a  binding  OEL  for  isoprene  in  the  annex  III  of 
CMRD.  According  to  them,  isoprene  is  an  intermediate  in  the  chemical  and  rubber  producing 
industry. The carcinogenicity of isoprene in animal studies has been clearly demonstrated and it is 
therefore  important  to  set  an  EU  limit  value  for  the  protection  of  workers  potentially  exposed  to 
isoprene. 

Moreover,  only  a  few  Member  States  have  a  national  OEL  for  isoprene  and  it  is  therefore  an 
additional argument to adopt an OEL for that carcinogen at EU level. 

As a general remark, workers’ organisations would like to draw the attention of the Commission on 
the recent adoption of an opinion of the ACSH on a risk-based methodology to set limit values for 
non-threshold carcinogens. Workers’ organisations believe that this methodology should be applied 
for  the  first  time  to  relevant  substances  subject  to  the  6th  amendment  of  CMRD  and  therefore 
considers  that  the  residual  risk  of  cancer  must  remain  in  the  agreed  risk  boundaries.  Moreover, 
workers’  organisations  demands  that  this  residual  risk  of  cancer  is  clearly  mentioned  in  the  legal 
text (new column in annex III). Information related to residual risk, made publicly available at EU 
level, would be valuable for future work to limit risks from occupational exposure to carcinogens, 
including  by  revising the  limit  values  set  out  in  this  Directive.  Transparency  of  such  information 
should be further encouraged. 

1.1.2.  Employers’ organisations  

During the meeting of 1st stage of social partners simplified consultation, employers’ organisations:   

•  expressed support to the new simplified format of the social partners consultation;   
•  highlighted  the  key  role  of  the  ACSH  and  its  WPC  in  the  process  of  developing 

• 

Commission’s legislative proposals;    
identified  welding  fumes  and  cobalt  and  its  inorganic  compounds  (and  to  a  lesser  extent 
PAHs) as the key substances for this planned initiative;  

•  stressed the need for better protecting workers while preserving the competitiveness of EU-

based companies; 

•  asked for having the second meeting of the social partners consultation after the adoption of 

the ACSH opinions on the 5 substances. 

In  their  written  response,  employers’  organisations  underlined  that  establishing  limit  values  or 
reviewing  the  existing  ones  has  always  a  strong  impact  on  SMEs.  An  approach  solely  based  on 
setting  limit  values  is  not  sufficient  for  effective  protection.  These  limits  must  also  be 
implementable  by  crafts  and  SMEs.  Therefore,  employers’  organisations  insist  that  the  socio-
economic impact of new OELs is well-taken into account and that small enterprises receive enough 
well adapted guidance, guidelines and monitoring tools on how to tackle the issue of carcinogens 
and  other  substances.  Furthermore,  on  the  issue  of  protective  equipment,  SMEs  also  require 
targeted advice as well as financial support. 

Employers’  organisations  welcomed  the  decision  of  the  European  Commission  to  place  new 
substances under the scope of the CMRD and agreed with its consultation document concerning the 

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necessity  to  heed  the  new  scientific  evidence  which  allows  to  better  understand  occupational 
hazards or exposure and allow for better prevention and protection at the workplace.  

Employers’  organisations  expressed  that  the  impacts  on  individual  health,  family  life  and  on 
national  health  and  social  systems  cannot  be  continually  ignored  and  thus,  in  parallel  of  the 
Europe’s Beating Cancer Plan of the Commission, actions to fight cancer at the workplace through 
continuous revision of the CMRD are considered as key to tackle the issue.  

Further,  employers’  organisations  stressed  the  need  to  carefully  evaluate  each  substance  and  to 
consider  their  specific  characteristics  and  impacts.  Nevertheless,  some  substances  have  a  greater 
level of complexity and could indirectly impact the European competitiveness (welding fumes) or 
switch  to  renewable  energies  (cobalt).  In  this  regard,  employers’  organisations  are  still  enquiring 
how their members will be indirectly impacted by the revision of the OEL, in particular members in 
energy and waste management sectors.  

Hence, employers’ organisations think that it is necessary to consider each substance separately and 
to carry out a socio-economic impact analysis on the outcomes and the challenges that could result 
from changing the exposure limit value of these substances. Therefore, the opinion of the ACSH’s 
WPC,  which  considers  the  technical  and  socio-economic  feasibility  of  changing  OEL,  is  crucial.  
However,  the  socio-economic  feasibility  should  not  play  a  disproportionate  role  in  establishing 
limit values.  

Employers’ organisations also believe that the limit values should be implemented in a transitional 
period.  The  revision  would  be  done  by  progressively  lowering  the  exposure  level,  which  would 
give companies the technical and financial capacity to change their way of producing. 

In  addition  to  the  above  more  general  remarks,  there  were  more  detailed  comments  concerning 
specific substances. 

a)  Welding fumes 

As regards welding fumes, employers’ organisations consider that the impact of stricter rules goes 
far beyond the metal sector and can affect almost all industry and handicraft sectors. It depends on 
the process of welding and the type of metal used. In their opinion, the background document could 
contain more data on the impact that the new OELs could have on reducing work-related diseases 
and  cancer.  It  would  be  necessary  to  have  a  more  thorough  analysis  of  the  impact  and  presumed 
benefits  of  setting  new  OELs.  In  addition,  the  socio-economic  impact  of  introducing  new  OELs 
needs to be duly taken into consideration when assessing cross-legislative impacts, in particular on 
achieving the goals of the European Green Deal.  

Employers’ organisations also drew attention to the additional possible impacts of introducing new 
OELs for welding fumes. These possible impacts include:  

•  apprenticeship  training:  Stricter  regulations  for  welding  fumes  can  become  an  unsolvable 
problem for apprenticeship training. There is a great danger that the related tightening (e.g. 
welding  ban  in  rooms  where  apprentices  are  also  employed)  will  result  in  apprenticeship 
training  in  metalworking  professions  being  called  into  question  or  no  longer  feasible.  By 
jeopardizing  apprenticeship  training,  the  new  rules  would  have  negative  consequences  far 
beyond the area of workers protection. In times of a shortage of skilled workers, this might 
lead to unwanted consequences.  

•  costs  burdens  due  to  necessary  retrofitting/conversions:  A  production  hall  or  workshop  in 
which welding is carried out would have to be converted or retrofitted with top exhaust air 

103 

 
• 

systems and extraction systems, welding cabins, etc., if this at all were technically possible 
and financially viable for the company.  
far-reaching concern: As already noted before, the concern goes far beyond the classic metal 
sector.  The  main  areas  affected  are  mechanical  engineering,  vehicle  construction,  plant 
construction,  rail  vehicles,  agricultural  machinery,  construction  (reinforcing  steel,  steel 
construction),  vehicle  repair  shops,  metalworking  shops,  maintenance  and  repairs  in 
production  companies.  Welding  equipment  is  used  throughout  the  maintenance  and 
production process. 

•  bureaucratic burdens: It should also be considered that new rules within the EU will make 

• 

the product more expensive and the added value could migrate out of the EU.  
relocation  of  production:  If  all  welding  fumes  are  classified  as  carcinogenic  and  a  limit 
value  is  set,  this  would  pose  a  massive  existential  threat  to  the  metalworking  sector. 
Substituting  alternative  processes  on  such  a  large  scale  would  not  be  possible  and  would 
also  not  be  economically  viable.  The  relocation  of  production  outside  the  EU  would 
probably be the result.  

b)  Cobalt and its inorganic compounds 

As regards cobalt and its inorganic compounds, employers’ organisations invited the Commission 
to assess thoroughly the impact of introducing an OEL, knowing that cobalt cannot be replaced by 
other  materials  in  some  sectors  (for  example,  dentistry).  As  for  the  other  substances,  the  socio-
economic impact of introducing a new OEL for cobalt and its inorganic products needs to be duly 
taken  into  consideration  when  assessing  cross-legislative  impacts,  namely  the  European  Green 
Deal. 

1.2.  Results of the 2nd phase of the social partners consultation 

The Commission launched a second phase consultation of the Social Partners which closed on 21 
November 2023.  

During the second stage of social partners consultation, social partners were consulted on objectives 
and avenues of EU action, possible legal instruments and willingness to enter negotiations with a 
view to  concluding an agreement under Article  155 TFEU.  In addition  to  the contributions  made 
during the 7 November 2023 meeting, three recognised social partners sent written replies during 
the  first-phase  consultation,  including  one  workers’  organisation  (European  Trade  Union 
Confederation – ETUC) and two employers’ organisations (BusinessEurope, SMEunited). 

In the second ad-hoc meeting which took place on 7th of November 2023, the Commission asked 
the Social Partners the following questions:  

-  What are your views on the objectives of possible EU action?  

Workers’  organisations  concur  with  the  analysis  put  forth  in  the  background  document  with 
analytical  elements,  especially  in  alignment with  the primary overarching  policy objective of this 
initiative, which is to uphold a strong standard of health and safety for workers throughout the EU. 
This  legislation  will  additionally  aid  in  establishing  a  consistent  standard  for  occupational  safety 
and  health  (OSH)  protection  within  the  EU,  thereby  diminishing  disparities  in  the  levels  of 
protection currently offered at the national level.  

104 

 
 
 
Employers’  Organisations  considers  it  necessary  to  take  all  the  necessary  legislative  and  non-
legislative  measures  for  ensuring  a  good  health  and  safety  environment  at  work  and  to  prevent 
diseases such as cancer. Crafts and SMEs employers recognise that adequate Occupational Health 
and  Safety  (OSH)  measures  help  to  prevent  risks  of  diseases  and  accidents  and  increase 
productivity. A good health and safety environment depends amongst others on the right legislative 
framework that is fit for purpose and support for compliance. Therefore, they (SME United) firmly 
support social partners’ involvement and engagement, and takes note of the opinions adopted by the 
Advisory  Committee  on  Safety  and  Health  and  would  like  to  point  out  that  limit  values  must  be 
technically and economically feasible for companies and be proportionate. Moreover, compliance 
with the new limit values must be monitored in each Member State to ensure a level-paying field. 

-  What are your views on the possible avenues for EU action?  

Workers’  organisations  representatives  endorse  the  first  option:  Enacting  binding  legislation  to 
address the protection of workers from exposure to the identified substances. Conversely, they are 
against the third option - guidance - as a considerable number of employers may not be motivated 
to invest in and adhere to OSH protection measures unless they are legally mandatory.  

Thus, they expressed support to the reviewing the directive and continue process to achieve the best 
possible protection of workers. They welcomed the tripartite opinion and considered that it is not 
necessary  to  reopen  the  debate  between  employers  and  trade  unions  because  the  dialogue  has 
already been carried out in the ACSH and it was a very fruitful dialogue. They would also like to 
see in the legal text considerations to the possibility of further reviewing the occupational exposure 
limits  and  other  measures  enacting  the  legislation  in  the  light  of  potential  future  scientific  and 
technological development, especially as regards cobalt. 

Workers’ organisations representatives stressed the need for harmonisation of national limit values 
to ensure the same level of protection for all EU workers and this can be realised by establishing 
EU-wide occupational  exposure limits  (OELs). This  can only  be done by a legislative instrument 
and  reviewing  the  directive  is  the  right  way  forward.  They  also  acknowledged  that  there  will  be 
costs for companies and they agree that, at the same time, there is a need to ensure protection of the 
economical and industrial sustainability of the EU companies from dumping and ensure protection 
of the safety and health of all workers without harming the competition. The need to improve the 
gender-based approach was also highlighted, because impacts of health on workers differ according 
to  gender  and  their  age,  take  into  consideration  the  exposure  to  combinations  of  substances  and 
consequences  of  these  combinations  of  substances,  promote  the  substitution  of  toxic  substances 
with  new  generation  of  substances  have  less  impact  and  a  recital  about  the  need  to  respect  the 
hierarchy of the protective measures to be provided by the employer reminding that technical and 
organizational protective measures should go before personal protective equipment and underlined 
the  importance  of  educating  workers  and  keep  them  healthy  and  safe  to  enable  them  to  work  by 
improving working conditions 

Employers’  organisations  support  guidance  documents  as  the  most  welcome  approach  or 
alternatively  moderate  step-by-step  amendments  of  the  current  directives  aiming  to  revise  or 
establish new binding limit values at the EU level. They (BusinessEurope) confirm what has been 
put forward by the Advisory Committee, recognises the outcome of these opinions as the balanced 
compromise  between  all  three  interest  groups  and  called  (SMEunited)  the  Commision  not  to  go 
beyond what  was  agreed by the ACSH and ensure sufficient  transition  periods for SMEs and the 
affected  sectors.  Considering  additional  expenses  for  SMEs  resulting  from  such  amendments  is 
highly  recommend  as  lowering  exposure  levels  for  these  specific  substances  will  have  a 
considerable  impact  on  companies’  activities,  already  overwhelmed  by  a  whole  set  of  standards. 

105 

 
Accompanying measures such as financial support and guidance should be foreseen to ensure that 
SMEs are able to adequately implement the new exposure levels. 

-  What are your views on the possible legal instruments presented?  

According to the Workers’ organisations (ETUC), the most advisable course of action is to revise 
the Directive 2004/37/EC of 29 April 2004 on the protection of workers from the risks related to 
exposure  to  carcinogens,  mutagens  or  reprotoxic  substances  at  work  and  calls  on  the  European 
Commission to respect the consensus reached by the Advisory Committee on Safety and Health at 
Work (ACSH) when presenting its legislative proposal to the European Council and the Parliament. 
Furthermore, they ask for the inclusion of the additional elements highlighted in its initial response 
to  the  first  consultation  such  as  defining  hazardous  medicinal  products  (HMPs),  addressing 
combined  exposure,  and  adopting  a  gender-specific  approach  as  guiding  principles  for  the 
legislation. 

They  reiterate  their  request  for  the  recognition  of  firefighters  as  a  carcinogenic  profession.  Their 
proposal  advocates  for  acknowledging  the  systematic  exposure  of  firefighters  to  carcinogens 
without specifically delineating a comprehensive list of "carcinogenic professions".  

Workers’  organisations  underscore  that  women  workers  are  vastly  underrepresented  in  research 
into  the  health  risks  that  are  associated  with  workplace  exposures  to  chemicals.  Likewise,  wrong 
assumptions  about  the  jobs  that  many  women  workers  undertake  can  mean  that  their  health  and 
safety  is  overlooked.  It  is  essential  that  the  Commission  includes  a  specific  focus  on  the  gender 
differences in this and its future initiatives to improve workers' protection from chemical risks.  

Additionally,  it's  crucial  to  address  all  factors  influencing  greater  exposure  to  risks  from 
carcinogens, mutagens, and reprotoxic substances. Special attention must be given to workers with 
various characteristics: advanced age, psycho-physical impairments, precarious working conditions, 
extensive  overtime  or  shift  work,  and  exposure  to  high  temperatures.  Not  undertaking  specific 
action to encompass these workers can lead to overlooking their health and safety risks. Therefore, 
they  consider  that  the  Commission  should  prioritize  a  comprehensive  approach  considering  these 
factors in future initiatives to enhance workers' protection from chemical risks.  

It is also crucial to establish precise implementation timelines at the outset of the revision process. 
This proactive approach aims to prevent unforeseen delays in the ordinary legislative procedure, as 
previously experienced with other occupational safety and health-related legislations”. 

Employers’ organisations stress the importance of ensuring the technical adaptation of SMEs both 
in  terms  of  production  and  protective  measures.  A  harmonised  approach  by  national  authorities 
exhausting  all  options,  including  personal  protective  equipment,  should  be  a  key  element  of  the 
future  revision  (e.g.:  use  of  protective  masks  and  time  allowed  for  using  the  same  mask). 
Employers’ organisations ask the European Commission to consider several elements in the impact 
assessment  accompanying  any  future  initiative  in  this  field.  Firstly,  a  thorough  analysis  of  all 
impacted sectors. For example, sectors which are key for the green transition are not the only ones 
using cobalt. Dentistry and other niche sectors are also using this substance and cannot substitute it. 
Secondly, Employers’ organisations recommend to well analyse the impact of the lower values on 
the competitiveness of companies. In many industries, the intended limit values cannot be achieved 
only through technical adjustments to the workplace, or with the substitution of the material. There 
is  a  need  to  use  personal  protective  equipment  such  as  respirators  to  ensure  that  workers  are 
adequately protected, and companies can comply with their legal obligations. Therefore, an impact 
assessment  regarding  the  impact  of  the  limit  values  on  the  goals  of  the  Green  Deal  as  well  as 
maintaining and strengthening competitiveness of European companies is essential.  

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Employers’  organisations  put  forward,  in  their  written  reply,  some  further  comments  on  the 
following substances:  

a)  Welding fumes  

Due to the frequent use of welding processes in industry and crafts in the EU, numerous economic 
sectors  will  be  impacted  by  a  potential  future  revision  of  the  limit  value.  If  in  the  future,  the 
substitution of welding is necessary, it would force companies to completely change their product 
design.  The  economic  impact  of  such  changes  should  duly  be  considered.  When  setting  limit 
values,  specific  attention  should  be  taken  to  ensure  that  the  impact  on  apprenticeships  is  well 
analysed. Classifying welding fumes as carcinogenic might damage the attractiveness of the whole 
sector and sharpen the labour and skills shortages. In addition, the impact assessment should also 
consider how the implementation can be realistically carried out in companies such as repair shops 
(motor vehicles, agricultural machinery, etc.) that only weld sporadically and how this affects the 
exposure of apprentices. A lack of career opportunities in the above-mentioned and related sectors 
further  increases  the  shortage  of  skilled  workers  and  may  contribute  to  a  further  loss  of 
competitiveness.  

While supporting the new proposed entry into Annex I: “Work involving exposure to fumes from 
welding processes containing substances that meet the criteria for CMR category 1A/1B set out in 
Annex I to the CLP regulation” they consider that a footnote should be added to  the new entry to 
Annex  I  in  line  with  the  ACSH  opinion  to  clarify  that  currently  Annex  I  contains  only  a  list  of 
carcinogenic  substances,  mixtures  and  processes  and  that  reprotoxic  substances,  mixtures  and 
processes  need  to  be  included  in  order  to  be  consistent  with  the  proposed  welding  fumes  entry. 
Furthermore, there is a need to distinguish between the requirements applying to carcinogens versus 
those for reprotoxic substances, clarifying that:  

for the new entry, reprotoxic effects have to be included, but not for the previous entries;  

• 
•  provisions for reprotoxic substances are not the same that for carcinogens or mutagens.  

Finally, the footnote should clarify that the entry in Annex I can only be applied to welding fumes 
under the following two conditions:  

• 

• 

they contain substances that are classified as carcinogens, mutagens or reprotoxic according 
to CLP;  
they exceed the relevant generic or specific concentration limit.  

The lack of this clarifying footnote could have potential adverse effects on the search for existing, 
but especially future skilled workers in an already tight labour market. As the welding profession 
deals  with  an  increasing  attractiveness  problem,  with  huge  shortages  of  qualified  welders  in 
amongst others the metal sector, labelling an entire profession as "carcinogenic" would not only be 
blatantly dishonest but could also have disastrous effects on the profession.  

The ACSH opinion clarifies that over a period of at least two years, guidelines will be created by 
the ACSH to clarify the introduction of this new entry into Annex I. They firstly underline that it is 
paramount  to  retain  this  timeline  as  the  absolute  minimum  to  avoid  overburdening  the  ACSH  in 
their  workload.  The  guidelines  should  furthermore  highlight  that  this  new  entry  can  only  be 
intended  to  raise  awareness  and  attention  to  the  fact  that  certain  welding  fumes  could  produce 
cancer  in  exposed  workers  and  preventive  measures  will  therefore  need  to  be  adopted  as  well  as 
health surveillance to prevent it.  

The guidance should furthermore refer to the following elements:  

107 

 
•  ensuring  that  occupational  exposures  to  the  individual  airborne  compounds  of  hygienic 
significance in welding fume can be maintained below established exposure limits (already 
fully considering the CMR status of the applicable fume components).  

•  providing  adequate  ventilation  is  ultimately  key  to  preventing  workplace  overexposures, 

and in turn, their potential health effects.  

•  continuing  to  evaluate  and  refine  welding  operations  for  the  reduction  of  airborne 
contaminants in accordance with established occupational exposure standards and industry 
guidelines.  

Finally, they note that a more detailed socio-economic impact assessment will be necessary for the 
entry of welding fumes into Annex I of the CMRD and should take into consideration the financial 
burdens,  especially  for  small  and  medium  sized  enterprises  in  the  EU,  due  to  necessary  new 
investments in plant technology for air pollution control. 

b)  Cobalt and its inorganic compounds  

Cobalt, among other most classical applications, is used in more niche sectors, such as in dentistry 
or for example, as a filler material in welding technology for wear-resistant cored wires. The range 
of uses for cobalt in this specific field is all types of wear protection layers (e.g. for drill heads in 
tunnel  construction,  excavator  shovels,  crushers).  The  area  of  use  is  hardly  known  to  the  public 
except  among  experts  but  is  of  great  importance  in  its  niche.  To  be  able  to  apply  such  wear 
protection layers, high proportions of cobalt are necessary in the filler material. Tight limit values 
are therefore very difficult to achieve. For example, it would be difficult to reapply worn excavator 
blades or similar, if the wear protection layer has been removed. In addition, the achievement of a 
limit value for cobalt also depends on the areas of production. There is a difference in the measured 
values  and  such  a  distinction  should  also  apply  in  the  future.  Finally,  Employers’  organisations 
would like to point out that cobalt cannot be substituted in many cases, therefore it is important to 
guarantee that sectors using this substance can continue to operate. 

Employers’  organisations  support  the  proposed  limit  value  of  20  µg  Co/m3  for  the  inhalable 
fraction  and  4.2  µg  Co/m3  for  the  respirable  fraction  as  a  reasonable  outcome.  Whilst  it  is  the 
lowest value in the world, many industries already meet these levels and achieving them has been 
shown  to  be  feasible.  They  furthermore  recognise  the  OEL  of  10  µg  Co/m3  2  for  the  inhalable 
fraction and 2.5 μg Co/m3 for the respirable fraction as the outcome of technical as well as political 
negotiations. However, it should be noted that an OEL value of 20 µg Co/m3 is already very strict. 
Any  tightened  level  will  require  long  transition  periods  due  to  the  high  level  of  investment  and 
potentially  innovation  needed,  for  companies  in  a  start-up  phase  with  production  in  constant 
development.  In  some  cases,  innovation  is  required  for  redesigning  process  equipment  and 
potentially the entire process. Furthermore, all the studies indicate that there is no increased cancer 
risk linked to  cobalt exposure at  the levels  that have been relevant  in  these studies. They include 
measurement  data  and  health  data  from  people  who  have  worked  since  the  50s  and  60s  when 
exposure levels were higher than today or are entirely based on animal studies.  

Employers’  organisations  stressed  on  the  need  for  a  more  detailed  and  evidence-based  socio-
economic impact assessment of the impact of the proposed OEL of 10 µg Co/m3 after the transition 
period of six years. They noted in this regard that the Cobalt Institute is currently in the process of 
conducting  such  a  study  to  estimate  the  real  cost  of  the  ACSH  opinion  as  the  basis  for  the 
Commission’s upcoming proposal. This will be crucial information as cobalt and inorganic cobalt 
compounds  is  considered  one  of  the  key  strategic  and  critical  raw  materials  at  the  basis  of  the 
European Commission's green transition and strategic autonomy ambitions.  

108 

 
Employers’ organisations underlined that in the Critical Raw Materials Act cobalt has been labelled 
a Strategic Raw Material, with benchmarks set to ensure 40% of Europe’s cobalt needs come from 
domestic  processing  and  refining,  and  15%  of  needs  come  from  domestic  recycling.  Applied 
specifically  to  cobalt,  these  targets  imply  that  Europe’s  cobalt  refining  and  processing  industry 
needs to grow by 122% (2.2 times) and recycling by 150% (2.5 times) by 2050. It will furthermore 
need to increase cobalt use by 350% by 2050 to meet the needs of the green transition, driven using 
cobalt in battery cathodes, with a 135% increase in cobalt jobs by 2030 alone. 

Employers’ organisations estimate that 65,000 new cobalt jobs will be created in the EU by 2030 to 
meet the demands of the green transition. This industry will require huge investments to grow to the 
size  needed  to  sustain  the  European  green  goals.  Nevertheless,  preliminary  figures  by  the  Cobalt 
Institute show that the implementation of the proposed OEL of 10 µg Co/m3 could:  

•  cost the industry 19.3 billion euros over 40 years;  
• 
• 

result in 110,000 job losses out of a total of 641,000 jobs;  
lead to the closure of 1,550 sites out of 9,000 sites in total.  

Ensuring the access to financial support as well as guidance to implement the OEL will therefore be 
necessary, for small and medium enterprises.  

Employers’ organisations expect that internal and foreign investment into this sector will decrease 
significantly due to overly stringent rules in the EU as compared to the rest of the world. This could 
result  in  the  likely  relocation  of  production  sites  to  countries  and  regions  outside  the  European 
Union and, associated with this, distortion of competition in international comparison, irrespective 
of  the  serious  effects  in  training  and  qualification.  This  initiative  could  therefore  have  more  far-
reaching  consequences  for  the  European  industry  than  only  the  increased  protection  of  workers. 
This  is  of  particular  importance  in  a  time  where  Europe  is  trying  to  refocus  on  increasing  their 
overall competitiveness as well as to position themselves as a more credible actor in line with 3 the 
principle  of  strategic  autonomy.  To  address  these  issues,  it  is  important  that  DG  EMPL  liaises 
closely with their colleagues from DG GROW to correctly assess the socio-economic impact of the 
proposed OELs on the European industry. 

Lastly, Employers’ organisations noted that cobalt and inorganic cobalt  compounds are used in  a 
wide range  of sectors e.g. batteries, sharpeners,  dentistry, etc.  Whilst  many sectors  want  to  make 
the necessary investments needed to achieve a new OEL, it should be noted that for some this will 
only  be  possible  through  the  accompanied  use  of  personal  protective  equipment  (PPE).  Ensuring 
that all Member States support the adequate access to PPE will therefore need to be an important 
element of the upcoming proposal by the Commission. 

c)  PAHs 

Employers’ organisations support the proposed limit value of 70 ng/m3as well as the proposed two-
step transition period for specific sectors or processes:  

•  2 years after entry into force of the directive, a BOEL of 140 ng/m³;  
•  6 years after entry into force of the directive, a BOEL of 70 ng/m³  

Nevertheless,  Employers’  organisations  underline  that  for  many  Member  States  the  proposed 
reduction of the OEL for PAH is significant and will require substantial investments, especially for 
indoor  workplaces.  For  example,  the  OEL  for  benzo(a)pyrene  in  Sweden  is  2,000  ng/m3,  as 
compared to the newly proposed BOEL of 70 ng/m3. For many Swedish companies, the first step 

109 

 
towards a lower BOEL of 140 ng/m³ is therefore already too large compared to the OEL of today. 
Against  this  background,  Employers’  organisations  call  upon  the  Commission  to  consider  the 
different starting points of the various Member States in implementing a new BOEL in the Impact 
Assessment. This will allow for a more robust cost-benefit analysis that better reflects the required 
investments  from  different  sectors  and  different-sized  companies  in  the  various  Member  States, 
with  the aim of developing a better-designed implementation  period for this substance to  achieve 
the OEL of 70 ng/m³. 

Are the European social partners willing to enter negotiations with a view to concluding an 
agreement under Article 155 TFEU with regard to any of the elements set out in Section 6?  

As regards willingness to enter negotiations with a view to concluding a Social Partners agreement, 
the social partners reaffirmed support the current process to amend the CMRD, including the key 
role of the ACSH/WPC, and do not want to initiate a dialogue under Article 155 TFEU  

2.  CONSULTATION OF THE ACSH/WPC  

The Advisory Committee on Safety and Health at Work (ACSH) has adopted opinions for welding 
fumes,  polycyclic  aromatic  hydrocarbons,  cobalt  and  its  inorganic  compounds,  1,4-dioxane  and 
isoprene in the context of the sixth amendment of the CMRD. 

The ACSH is  proposing as  possible approaches for these chemicals  one  or several  binding OELs 
with additional notations for all of them. 

The opinions for all substances adopted by the ACSH are summarised below. 

110 

 
 
 
 
 
 
 
Name of agent  

EC No  

CAS 
No  

    Limit values  

Notation  

Transitional measures  

Table 33 - ACSH recommendations for Annex III and Annex IIIa 

8 hours  

Short-term    

mg/m3      

ppm

f/ml   mg/m3  ppm   f/ml  

10  µg/m3 
(inhalable 
fraction)  
2.5µg/m3 
(respirable 
fraction)  
70 
ng/m3  

(*) 

its 

-  

-  

Cobalt  and 
inorganic 
compounds  

-  

-  

Polycyclic 
aromatic 
hydrocarbons 
mixtures, 
particularly  those 
containing 
benzo[a]pyrene, 
which  are  which 
are  carcinogens, 
mutagens 
or 
reprotoxic  within 
the  meaning  of 
this Directive   

0.45   -  

-  

-  

-  

Dermal  and 
respiratory 
sensitisation  

(inhalable 
Limit  Values  of  20  µg/m³ 
fraction) and 4.2 µg/m³ (respirable fraction) 
until  6  years  after  entry  into  force  of  the 
Directive  

-  

-  

-  

-  

-  

skin   

111 

and 

graphite 

Limit  value  of  140  ng/m³  for  the  following 
sectors:   
•steel  and  iron  foundries,  which  includes 
ferroalloy manufacturers;  
• aluminum manufacturers;  
• carbon 
manufacturers;  
• coking plants;  
• coal tar distillation;  
• manufacture of refractory products;  
• welding of train tracks.  
• other non-ferrous metallurgical processes  
•  casting of metals.  
until  6  years  after  entry  into  force  of  the 
directive  

electrode 

 
 
  
  
  
  
  
  
  
  
    
  
  
1,4-dioxane  

Isoprene  

204-661-
8  
201-143-
3  

7.3  

123-91-
1  
78-79-5   8.5  

(*) measured as benzo[a]pyrene 

2.0  

-  

73  

20  

3  

-  

-  

-  

-  

-  

Skin  

-  

-  

-  

The ACSH recommended for 1,4 dioxane the setting of a binding biological limit value of 45mg HEAA in urine/g Creatinine, at the end of exposure or 
shift.  

ACSH recommendations for Annex I 

The ACSH strongly recommends the Commission to adopt as soon as possible the below new entry into Annex I under Directive 2004/37/EC: 

•  Work involving exposure to fumes from welding processes containing substances that meet the criteria for CMR category 1A/1B set out in Annex I to 

the CLP regulation1. 

1 The limit values listed in annex III of this directive must be respected if a given welding process is related to an exposure to CMR substances. Most of 
the relevant hazardous substances for welding processes are already listed there (or are on the way to be listed). 

112 

 
3.  CONSULTATION OF OTHER STAKEHOLDERS 

In the context of the external study, consultation activities have been carried out to collect detailed 
information  on  the  potential  impacts  of  modifications  to  the  CMRD  that  is  not  available  in 
published literature and internet  searches via desk-based research. Although  some information  on 
current  OELs,  STELs,  BLVs  and  notations  is  available,  limited  information  is  available  on  the 
specific concrete risk management measures already in place, as well as those that would need to be 
implemented, should the proposed measures be introduced into the CMRD. 

The primary aim of the consultation activities was to identify information not available via desk-
based  research.  Consultation  carried  out  for  the  purposes  of  the  study  consisted  of  the  following 
main activities: 

• 

targeted questionnaires, these included: substance specific questionnaires, Member State 
Authorities, OSH Experts, Trade Unions and a further short questionnaire for welding; 
• 
interviews; 
•  site visits; and 
•  conversations (these consisted of email exchanges and online calls). 

The  study  team  have  consulted  a  range  of  organisations  whose  activities  are  relevant  to  the  five 
substances. Information collected via consultation included the sectors and processes in which the 
relevant substances are used, the size of companies that would be impacted, estimates of numbers 
of workers exposed currently, current air concentrations of substances concerned (both 8-hour time 
weighted averages (8-h TWA) and 15-minute reference periods), current biological limit values, as 
well  as  risk  management  measures  currently  in  place,  and  risk  management  measures  that  would 
need to be implemented should the limits be introduced and the associated costs.  

Consultation  activities  have  been  conducted  by  those  with  expertise;  substance  experts  (those 
writing the substance-specific reports) and national experts (with knowledge of the situation in their 
Member State and native language competence) conducted the interviews with stakeholders.  

A large amount of information has been collected via consultation, particularly through means of 
the  targeted  online  questionnaires,  telephone  interviews  and  email  correspondence.  Efforts  have 
been made to contact a variety of relevant stakeholders (see Table 34)  in all the Member States, for 
each  of  the  relevant  substances,  from  companies  of  varying  sizes.  Through  the  combination  of 
desk-based  research,  questionnaire  responses,  interviews,  and  site  visits,  it  has  been  possible  to 
compile  a  significant  amount  of  detailed  information  in  relation  to  the  potential  impacts  of 
introducing the proposed measures. 

3.1.  Targeted online questionnaires  

Around  691185  stakeholders  were  invited  to  take  part  in  the  questionnaire.  However,  the  true 
number  of  stakeholders  that  were  contacted  is  likely  to  be  higher  as  many  industry  and  EU 
associations  were  contacted  and  asked  to  distribute  the  survey  to  their  members.  The  online 

185 Companies 15.63% , Education and Training 0.14% , Industry associations 59.62% , Laboratories 0.14%, Public 
authority 20.69% , NGO 1.45% , OSH Professional 2.32%  

113 

 
 
 
 
targeted  survey  opened  on  23  January  2023  and  ran  until  27  March  2023.  The  deadline  was 
extended twice to allow for a broader range of stakeholders to respond and address low response 
rates for certain substances.  

Stakeholders  were  initially  contacted  via  email.  A  link  rather  than  an  attachment  was  used  to 
decrease  the  size  of  the  email  and  reduce  the  number  of  emails  automatically  directed  to  junk 
folders. Five separate questionnaires were created for each of the substances for companies, three 
for  the  different  stakeholder  groups  (Member  State  Authorities,  Occupational  Safety  and  Health 
Experts, Trade Unions) and an additional welding questionnaire: 

The  questionnaires  for  companies,  from  which  approximately  50%  represents  SME’s,  were 
available as a link to EU Survey. The questionnaire for Member State authorities and occupational 
safety and health experts was available as a Word document which could be downloaded and sent 
using  the  designated  email  address.  Trade  Unions  and  specific  welding  stakeholders  were  also 
contacted by national experts and invited to interview for the questionnaire.  

The questionnaires aimed to collect information on processes during which worker exposure to the 
substances  in  question  is  likely  to  occur,  risk  management  measures  that  are  already  in  place, 
current  exposure  concentrations,  risk  management  measures  that  would  need  to  be  implemented 
should the limit be lowered, and any other impacts that could result from the introduction of EU-
level  limits.  As  mentioned  above,  the  questionnaires  were  targeted,  focusing  on  the  evidence 
needed for the analyses. In that regard, particular focus was placed on risk management measures, 
as only limited information on these is available in the literature. 

Translations  of  each  of  the  substance  questionnaires  were  available  in  German,  French,  Italian, 
Polish and Spanish and respondents also had the option to ask for the questionnaire in a language of 
their choice. Translations were initially requested through EU Survey and were then checked and 
edited by the National Experts. 

At  the  end  of  the  questionnaire,  respondents  were  given  the  opportunity  to  add  any  further 
comments  and  were  asked  if  they  were  willing  for  a  substance  expert  to  ask  potential  follow-up 
questions  and  whether they would be willing  to  host a site visit.  Follow-up interviews  were very 
useful when there were gaps in a stakeholder’s response and questions could be asked further to fill 
in  missing  information.  Other  consultation  methods  were  used  to  probe  further  into  respondents’ 
answers and gain a more in-depth understanding of the topic and potential impacts.  

3.2.  Online interviews 

National  experts  and  substance  specific  experts  conducted  interviews  with  relevant  stakeholders 
(see  Table  34)  .  Some  of  the  interviews  were  based  on  the  responses  to  the  questionnaire.  The 
meeting notes were shared with the company after the interview, and that occasion was also used to 
ensure mutual agreement on the level of confidentiality required.  

Online interviews were conducted with stakeholders whose activities are relevant to the five sub-
stances. The aim of these interviews was to build upon the information provided in response to the 
questionnaires,  to  fill  any  information  gaps.  and  to  obtain  detailed  information  on  processes,  to 
pinpoint  exactly where exposure is  likely  to occur, to  investigate what types of risk management 
measures  are  already  in  place  and  how  effective  they  are,  as  well  as  what  risk  management 
measures  would  be  required  if  limits  were  lowered  and  other  potential  ramifications  for  the 
company, etc. 

114 

 
3.3.  Conversations 

Email  requests  have  also  been  used  to  collect  information  for  the  study.  The  purpose  of  email 
requests  is  similar  to  the  interviews,  with  stakeholders  being  asked  for  further  detail  on  their 
answers to the questionnaire, as well as making requests for additional information such as industry 
statistics.  

3.4. 

Site visits  

Companies whose activities are likely to be affected by the potential modifications to the CMRD 
were also asked whether they would be willing to welcome for a site visit. Companies to be visited 
were identified via the questionnaire or via contact established via industry associations. 

The purpose of the site visits was to gain a more operational understanding of the risk management 
measures currently in place to protect against exposure to the substances concerned, as well as of 
the risk management measures that would be needed should the CMRD be modified. 

Detailed  notes  from  each  site  visit  were  drafted  and  sent  back  to  the  company  to  ensure  that  the 
information  recorded  is  accurate.    This  process  enabled  the  company  to  add  more  detail  and  in-
formation to the study, where possible, and to confirm the level of confidentiality accorded to the 
information. 

Site  visits  were  undertaken  during  Spring  and  Summer  2023,  once  significant  progress  had  been 
made  with  data  collection.  This  ensured  that  site  visits  added  more  nuance  to  the  data  already 
collected and helped to fill remaining information gaps. 

3.5. 

Stakeholders targeted 

The  following  table  summarises  information  on  stakeholder  groups  targeted  and  the  interests 
represented. The table demonstrates that all relevant stakeholder groups have been reached out to.  

Table 34 - stakeholders targeted and interests represented 

Stakeholder type 
EU Associations and REACH Consortia 
Member State Authorities 
Manufacturers/users 
National industry associations 
Trade Unions 
Occupational 
Professionals 
Working Party on Chemicals (WPC) 

Health  & 

Safety 

Laboratories 
Source: RPA (2024)  

3.6.  Key findings  

Interests represented 

Industry 
Member State authorities 
Industry 
Industry 
Workers 
Contacted to obtain scientific information 

Industry 
Workers 
Member State Authorities 
Contacted to obtain information on sampling and analysis 

The  feedback  received  from  consultation  of  stakeholders  suggested  that  the  lowest  of  the  OEL 
options  would  pose  substantial  challenges 
their 
competitiveness  and  financial  stability.  Small  and  medium-sized  enterprises  (SMEs)  expressed 
particular concern about the potential impacts of implementing lower occupational exposure limits 

to  certain  SMEs,  potentially  affecting 

115 

 
 
(OELs).  The  potential  costs  and  competitiveness  challenges  associated  with  these  limits  were  a 
significant worry for smaller companies. 

There  was  an  acknowledgment  of  the  need  for  effective  risk  management  measures  to  protect 
workers  from  exposure,  with  discussions  on  existing  measures  and  those  needed  if  limits  were 
adjusted.  The  financial  burden  of  complying  with  stricter  OELs  was  a  significant  concern, 
especially  for  small  companies  in  specific  sectors.  These  companies  faced  a  higher  cost  as  a 
proportion of annual turnover if strict limits were implemented. 

Specific  information  obtained  from  the  stakeholder  consultation  on  exposure  levels,  exposed 
workforce, applied RMMs, costs of compliance with reference OELs, etc.  is included in the sub-
stance-specific reports186.  

3.7.  Cobalt Institute’s impact assessment  

During  the  stakeholder  consultation,  the  Cobalt  Institute  submitted  three  reports  prepared  spe-
cifically for the purpose of providing information for the study. The studies have been presented by 
the Cobalt Institute for the Working Party on Chemicals (WPC) at a videoconference August 2023.  
According to the presentation for the WPC, the Institute supports establishing an OEL at EU level 
for the inhalable fraction at 20 µg/m3.   

No similar reports were submitted for the other four substances. 

The  impact  assessment  commissioned  by  the  Cobalt  Institute  and  prepared  by  the  consultancy 
company eftec as well as data on exposure levels and CSRs (Chemical Safety Reports) provided by 
the Cobalt Institute have been used as key stakeholder inputs for the external study. The data have 
been assessed along with data obtained from stakeholder surveys and other available data sources. 
With  regard  to  exposure  levels,  exposed  workforce,  and  number  and  companies  with  exposed 
workers - for those sectors covered by the Cobalt Institute impact assessment - the estimates used 
for the external study are well in accordance with the data provided by the Cobalt Institute.   

The  Cobalt  Institute  impact  assessment,  however,  estimates  the  total  costs  of  compliance 
significantly  higher  than  estimated  for  the  external  study.  The  background  for  the  differences  in 
estimated compliance costs between the two impacts assessments can be summarised as follows: 

1.  The  overall  methodology  applied  is  different  between  the  two  impact  assessments:  The 
Cobalt  Institute  impact  assessment  extrapolates  the  costs  and  compliance  level  from  survey 
responses  from  59  companies  to  a  total  of  4,962-9,821  companies.  The  costs  of  compliance 
with each policy option are extrapolated from the costs estimated by those companies, which 
consider they would not be in compliance with the policy option. At an OEL of 20 µg/m³, as an 
example, 22% of the respondents consider they would not be in compliance, i.e. the total costs 
for  all  sectors  are  extrapolated  from  responses  from  about  10  companies  representing  only 
some sectors. The external study applies a costs model which use actual exposure levels across 
sectors  and  the  modelled  costs  of  reducing  the  exposure  levels  in  order  to  be  in  compliance 
with the different policy options. The cost model has been used for impact assessments of more 
than 10 substances/substance groups under this and previous OELs assessments. The average 
costs  provided  by  the  companies  for  the  Cobalt  Institute  impact  assessment  are  for  large 

186 RPA (2024), op. cit. 

116 

 
 
 
companies  and  SMEs  well  in  accordance  with  the  estimates  provided  by  companies  for  the 
external study and likely many of the respondents for the two impact assessments are the same. 
For the external study the costs provided by the companies have been used for informing the 
study  and  model  estimates  but  are  not  considered  representative  and  has  not  been  used  for 
extrapolation. 

2.  The  two  studies  assume  different  shares  of  large  companies.  The  Cobalt  Institute  impact 
assessment  assumes  for  the  extrapolation  of  costs  that  19%  of  the  companies  with  exposed 
workers are large companies (the percentage reflects the percentage of responding companies). 
The external study estimates the share of large companies at 5% based on an assessment of the 
sector  structures.  For  comparison,  the  overall  share  of  large  companies  within  the  covered 
sectors in the Eurostat SBS (Structural Business Statistics) is 0.7%. The extrapolation of unit 
costs of large companies to a high share of all companies results in significant higher costs in 
the Cobalt Institute impact assessment than estimated in the external study. 

3.  The Cobalt Institute impact assessment is based on the assumption that companies for all 
processes have  to achieve compliance with the OELs without taking RPEs (Respiratory 
Protection Equipment) into account. The external study provides data on exposure levels 
by sector both with and without RPE. These data demonstrates that for some processes, the 
exposure levels  without  taking the used RPE into account  (i.e. the  exposure  concentration in 
the workplace) are typically above the highest of the policy option of 20 µg/m³ but is below 20 
µg/m³  when  the  applied  RPE  is  taken  into  account.  For  the  costs  estimates  for  the  external 
study, in accordance with the methodology used in previous impact assessments, it is assumed 
that  RPE  may  be  used  to  bring  the  exposure  below  the  OEL  for  some  exposure  situations 
where the use of RPE is in  general  accepted today and where the scope  for further technical 
preventive  measures  for  limiting  workers'  exposure  has  already  been  exhausted  (e.g.  some 
cleaning  and  maintenance  operations).  This  result  in  major  differences  in  costs  estimates  in 
particular at the higher OEL levels. It should be noted that the use of RPE is last resort and the 
CMRD  in  any  case,  irrespective  of  an  OEL,  stipulates  that  other  RMMs  should  be  applied 
where possible. 

4.  The  Cobalt  Institute  impact  assessment  assumes  that  all  companies  would  need 
biomonitoring  and  this  account  for  a  significant  part  of  total  costs.  The  costs  of 
biomonitoring are estimated in the Cobalt Institute impact assessment at 33% for an OEL of 10 
µg/m³  and  around  38%  for  an  OEL  of  20  µg/m³.  As  RAC  has  not  proposed  a  BLV  and  the 
CMRD  does  not  require  that  compliance  with  an  OEL  is  demonstrated  by  use  of 
biomonitoring,  it  is  in  the  external  study  considered  that  companies’  possible  costs  of 
biomonitoring cannot be allocated to the introduction of an OEL. 

5.  The  Cobalt  Institute  impact  assessment  assumes  that  companies  need  annual  air 
monitoring in order to demonstrate compliance and this account for a significant part of 
the  total  costs.  The  costs  of  air  monitoring  are  estimated  in  the  Cobal  Institute  impact 
assessment  at  12%  for  an  OEL  of  10  µg/m³  and  around  14%  for  an  OEL  of  20  µg/m³.  The 
external  study  applies  a  model  for  calculating  monitoring  costs  based  on  an  assessment  of 
actual  practice  of  monitoring  and  the  requirements  of  the  CMRD  and  the  European  standard 
for  demonstrating  compliance  with  an  OEL  (EN  689:2018+AC:2019).  The  estimated 
incremental  costs  are  significantly  lower  than  estimated  by  the  Cobalt  Institute  impact 
assessment  as  the  compliance  costs  model  takes  into  account  that  many  companies  already 
undertake  monitoring  today  and  that  the  frequency  of  compliance  monitoring  will  be  lower 
when companies have implemented the necessary RMMs and demonstrated compliance.  

117 

 
 
 
ANNEX 3: WHO IS AFFECTED AND HOW? 

1.  PRACTICAL IMPLICATIONS OF THE INITIATIVE 

1.1.  Consumers/workers  

-  Some  of  the  quantified  costs  to  business  may  be  passed  on  to  the  citizens/consumers  as 
increased  prices.  However,  the  impact  on  consumers  should  be  limited  or  even  negligible 
for all substances. 

-  Workers must comply with the dispositions provided by the employers as regards the use of 
preventive and protective measures necessary to comply with OSH legislation (e.g. the new 
binding limit values). 

-  Some workers exposed to cobalt and its inorganic compounds, PAHs or 1,4-dioxane might 

lose their jobs because of the new limit values set at EU level.    

-  Workers  would  be  better  protected  from  the  exposure  to  the  substances  subject  to  this 
initiative, leading to the prevention of 1,676 lung cancer cases and 18,912 non-cancer cases, 
resulting in cost savings of up to €1.16 billion. 

- 

In  addition  to  the  direct  benefits,  it  will  result  in  decreased  loss  of  present  and  future 
earnings (both for the person affected and for their carers.  

1.2.  Businesses  

-  Some businesses have to adjust the working practices to comply with the new limit values 
or  following  the  improved  legal  clarity  related  to  welding  fumes,  in  particular  making 
investments to reinforce existing risk managements measures, such as additional ventilation 
systems  or  closed  systems  (e.g.  adjustment  costs  will  be  more  predominant  for  PAHs, 
followed by cobalt and inorganic cobalt compounds and welding fumes).  

- 

- 

Improved  health  and  safety  at  work  results  in  direct  cost  savings  for  businesses,  such  as 
higher  labour  productivity  or  reduced  administrative  or  legal  costs  relating  to  workers’ 
illnesses, accounting for €7 million (without counting indirect benefits).  

Improved  health and safety  at  work as  a result of  adjusted working practices and  reduced 
reputational  risks  can  result  in  improved  staff  recruitment  and  retainment  rates  for  some 
businesses, with the potential to reduce recruitment costs and increase workers’ productivity 
as a result of reduction in absenteeism.  

1.3. 

Public authorities  

-  Public authorities must transpose the amendment to the CMRD into national legislation.  

-  Public authorities have to make investments in additional RMMs to ensure compliance with 

the new limit value for PAHs, accounting for about 62.5 million.  

-  Public  authorities  benefit  from  reduced  healthcare  treatment  costs  and  higher  productivity 

due to avoided illnesses.  

118 

 
 
2.  SUMMARY OF COSTS AND BENEFITS 

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

Description 

Amount 

Direct benefits 

Comments 

Cost  savings  for  workers 
and their families 

Method 1: €1.16 billion 
Method 2: €600 million 

Cost savings for businesses 

€7 million 

Cost  savings 
authorities 

for  public 

€26.65 million 

Cost  savings 
authorities  

for  public 

(up to) €3.75 million 

Indirect benefits 

Note: estimates are rounded and relative to the baseline.  

More  effective  protection  of  their  health, 
reducing  suffering  of  workers  and  their 
length,  quality  and 
families, 
productivity  of 
lives, 
avoiding ill-health. 

their  working 

increased 

i.e.:  higher 

Cost  savings  made  by  businesses  due  to 
workers  being  less  at  risk  of  work-related 
illness, 
labour  productivity 
resulting  from  reductions  in  absenteeism 
and  associated  production  losses,  reduced 
administrative  or  legal  costs  relating  to 
workers  who  are  ill,  reduced  insurance 
premiums,  reduced  reputational  risks  and 
reduced sick leave payments.   

In  addition,  not  quantified  benefits  include 
legal  clarity,  simplification  in  ensuring 
legal compliance and a more balanced level 
playing field for businesses across the EU.  

Cost  savings  made  by  public  authorities, 
i.e.: healthcare treatment costs, productivity 
loss  due  to  mortality  and  lost  earnings  due 
to morbidity.   

to  define 

Cost  savings  made  by  public  authorities 
from  not  having 
their  own 
national  limit  values,  as  a  result  of  the 
introduction of an EU limit value. Defining 
a  national  limit  value  has  associated  costs 
for  public  authorities  to  carry  out  impact 
assessments  and  define  a  suitable  level  of 
avoided risk.  

II. Overview of costs – Preferred option 

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

119 

 
 
 
 
 
 
 
Direct adjustment costs187 

(At least)  
€511 million 

(Less than) 
Method 1: €2.9 billion 
Method 2: €3 billion   

€16 million 

€46.5 million 

Direct monitoring costs 

Direct administrative costs 

€0 

€0 

Transposition costs  

€456 million 

€78.5 million 

€0 

€0 

€390,000 

€90,000 

(up to) €2.7 million 

€0 

Note: estimates are rounded and relative to the baseline.  

III. Application of the ‘one in, one out’ approach – Preferred option(s) 

One-off 

Recurrent 

Total 

[million€] 

(annualised total net present 
value over the relevant period) 

(nominal values per year) 

Businesses 

New administrative 
burdens (INs) 

Removed administrative 
burdens (OUTs) 

Net administrative 
burdens* 

€0 

€0 

€0 

€78.5 million 

€78.5 million 

€0 

€0 

€78.5 million 

€78.5 million 

Adjustment costs** 

(At least)  
€511 million 

(Less than) 

Method 1: €2.9 billion 
Method 2: €3 billion   

Citizens 

New administrative 
burdens (INs) 

Removed administrative 
burdens (OUTs) 

Net administrative 
burdens* 

Adjustment costs** 

Total administrative 
burdens*** 

€0 

€0 

€0 

€0 

€0 

€0 

€0 

€0 

€0 

€0 

€0 

€0 

€78.5 million  

€78.5 million 

(*) Net administrative burdens = INs – OUTs;  
(**)  Adjustment  costs  falling  under  the  scope  of  the  OIOO  approach  are  the  same  as  reported  in  Table  2  above.  Non-
annualised values;  
(***) Total administrative burdens = Net administrative burdens for businesses + net administrative burdens for citizens. 

187 In the absence of sufficient data to split the adjustment costs for welding fumes between one-off and recurrent, they 
are all considered recurrent costs.  

120 

 
 
 
 
 
 
 
 
3.  RELEVANT SUSTAINABLE DEVELOPMENT GOALS 

IV. Overview of relevant Sustainable Development Goals – Preferred Option(s) 
Relevant SDG 

Expected progress towards the Goal 

Comments 

SDG  no.  3  –  Good  health 
and well-being 

Expected  prevention  of  1,410  lung  cancer  cases 
and about 19,000 non-cancer cases over the next 
40 years.  

SDG  no.  8  –  Decent  work 
and economic growth  

Expected  higher  economic  productivity  and 
secure  working 
promotion  of 
environments  due  to  the  better  health  protection 
of about 2.65 million workers.  

safe 

and 

The  expected  progress  might  be  slightly 
mitigated  by  the  introduction  of  transitional 
measures  for  cobalt  and 
inorganic 
compounds, and PAHs.  

its 

The  expected  progress  might  be  slightly 
mitigated  by  the  introduction  of  transitional 
measures  for  cobalt  and 
inorganic 
compounds,  and  PAHs.  Furthermore,  it  is 
expected that 4,000 workers would lose their 
job  following  the  introduction  of  protective 
limit  values  for  cobalt  and  inorganic  cobalt 
compounds, PAHs and 1,4-dioxane.  

its 

121 

 
 
 
 
 
ANNEX 4: ANALYTICAL METHODS AND MULTI-CRITERIA ANALYSIS 

This annex provides a summary of the key data and assumptions used for the purpose of this impact 
assessment  to  monetise  and  quantify  the  different  key  impacts  identified,  where  possible.  More 
information  is  available  in  the  relevant  report  of  the  external  study188  supporting  this  impact 
assessment.   

1. 

IDENTIFICATION OF THE KEY IMPACTS 

The  table  below  summarises  the  key  impacts,  which  are  screened  to  identify  all  potentially 
important impacts – considering both positive/negative, direct/indirect, intended/unintended as well 
as short/long-term  effects.  The impacts  considered to  be the most significant  are indicated with  a 
"Yes".  

Table 35 - relevant key impacts for the purpose of this impact assessment 

Impact category 

Climate 

Quality of natural resources (water, soil, air etc.) 

Biodiversity, including flora, fauna, ecosystems, and landscapes 

Animal welfare 

Working conditions, job standards and quality 

Public health & safety and health systems 

Culture 

Governance, participation, and good administration 

Education and training, education, and training systems 

Conduct of business 

Position of SMEs 

Administrative burdens on business 

Sectoral competitiveness, trade, and investment flows 

Functioning of the internal market and competition 

Public authorities (and budgets) 

Sustainable consumption and production 

Efficient use of resources renewable & non-renewable 

Land use 

The likelihood or scale of environmental risks 

Employment 

Income distribution, social protection, and social inclusion of particular groups) 

Technological development / digital economy 

Consumers and households 

Capital movements; financial markets; stability of the euro 

Territorial impacts (specific (types of) regions and sectors) 

188 RPA (2024), op. cit., Methodological note and consultation synopsis 

122 

Yes/No 

N 

Y 

N 

N 

Y 

Y 

N 

N 

N 

Y 

Y 

Y 

Y 

Y 

Y 

N 

N 

N 

Y 

Y 

N 

Y 

Y 

N 

Y 

 
 
 
Innovation (productivity and resource efficiency); research (academic and industrial) 

Fraud, crime, terrorism, and security, including hybrid threats 

Resilience, technological sovereignty, open strategic autonomy, security of supply 

Transport and the use of energy 

Food safety, food security and nutrition 

Waste production, generation, and recycling 

Third countries, developing countries, and international relations 

Sustainable development 

Fundamental rights 

Subsidiarity and proportionality principles 

Source: RPA (2024) 

2.  DERIVATION OF THE ERRS AND DRRS  

Y 

N 

N 

N 

N 

N 

N 

Y 

Y 

Y 

The exposure-risk relationship (ERR) of a carcinogenic substance refers to the relationship between 
the  substance  concentration  and  the  statistical  probability  of  developing  cancer  (additional  risk 
beyond  the  background  incidence).  The  dose-response  relationship  (DRR)  is  the  relationship 
between the amount of exposure (dose) to a substance and the resulting changes in body function or 
health (response). 

The  starting  point  for  a  health  risk  impact  assessment  is  the  OEL  (and/or  an  ERR)  proposed  by 
RAC and the respective RAC opinion, together with the annexed background report.  

For PAH and cobalt and inorganic cobalt compounds RAC provided ERRs for the assessment of 
cancer risks. In case of PAH a linear ERR based on Benzo[a]pyrene (BaP) as an indicator substance 
was  derived  to  estimate  the  risk  of  lung  cancer  after  exposure  to  PAH  mixtures.  For  cobalt  and 
inorganic  cobalt  compounds  RAC  also  derived  an  ERR  for  the  risk  of  lung  cancer  with  a  break 
point to reflect the amplifying effect of the inflammation in the lung on cancer development above 
the break point.   

Despite  the  fact  that  1,4-dioxane  is  classified  as  a  1B  carcinogen,  no  ERR  was  derived  by  RAC 
This  is  due  to  the  fact  that  1,4-dioxane-mediated  carcinogenicity  is  only  relevant  above  the 
saturation level of the metabolism which is in humans above 180 mg/m³. Since this value is above 
the  highest  policy  option  considered  in  the  current  project,  carcinogenicity  of  1,4-dioxane  is  not 
considered, no ERR is derived, and non-cancer endpoints are in the focus for the current project. 

For isoprene RAC did not derive an ERR either. RAC followed the approach by other institutions 
and  proposed  an  OEL  which  considers  the  internal  isoprene  formation  in  humans.  However, 
carcinogenicity  of  isoprene  is  also  relevant  at  low  concentration.  Therefore,  an  ERR  based  on 
animal  data,  considering  the  differences  between  animals  and  humans  regarding  the  metabolism 
was derived for the current assessment.  

The  assessment  of  welding  fumes  was  limited  to  the  policy  option  of  including  this  process-
generated  mixture  into  Annex  I  of  the  CMRD.  An  ECHA  scoping  report  on  welding  fumes 
analysed the scope of welding fumes and similar fumes in the context of their potential inclusion in 
Annex  I.  In  the  absence  of  reliable  dose-response  data  for  cancer  and  non-cancer  health  effects 
neither  ERRs  nor  DRRs  could  be  derived.  The  results  from  a  recent  meta-analysis  on  the 

123 

 
 
epidemiological  evidence  for  lung  cancer  caused  by  welding  fumes  were  used  to  describe 
approximate risk levels under the conditions of the workplaces. 

For  non-cancer  endpoints,  the  RAC  opinions  as  well  as  other  recent  evaluations  and  literature 
reports, have been reviewed to identify the most relevant endpoints for humans. The RAC opinions 
were  always  used  as  the  key  source  of  information.  In  those  cases  where  it  was  necessary  to  fill 
information gaps, the sources used did not contradict or challenge the conclusions of RAC.  

3.  ESTIMATION AND MONETISATION OF HEALTH IMPACTS 

3.1. 

Introduction 

The current and future cases of ill health (current burden of disease and future burden of disease) 
have been estimated for both cancer and non-cancer endpoints using the following inputs: 

•  ERRs and  DRRs for the relevant health effects; 
•  Numbers of workers exposed; 
•  Exposure concentrations; and  
•  Past and future trends in the exposed workforce and exposure concentrations. 

3.1.1.  Cost categories considered for the estimation of cost savings from avoided 

ill-health (benefits) 

Focusing on the example of cancer, the costs of cancer can be divided into: 

• 

•  Direct costs: these are the costs of healthcare, namely the medical costs associated with the 
treatment of cancer and other costs, including non-medical costs. Other direct costs may be 
incurred by the patients (say the cost of transport to attend appointments) but also by their 
family/friends, for example, through providing unpaid care.  
Indirect  costs:  these  are  the  monetary  losses  associated  with  the  time  spent  receiving 
medical care, including productivity losses due to time spent away from work or other usual 
activities and lost productivity due to premature death.  Depending on the national structure 
of  social  security  provision,  the  government  (tax  payers)  may  also  bear  the  costs  of  any 
disability/social security payments and will also suffer losses through foregone tax receipts. 
Intangible costs: these include the non-financial ‘human’ losses associated with cancer, e.g. 
reduced quality of life, pain, suffering, anxiety and grief. 

• 

3.1.2.  The model 

The following table provides a summary of the key endpoints per substance for which quantitative 
estimations are provided in this impact assessment. 

Table 36 - carcinogenic and non-carcinogenic endpoints 

Substance 

Carcinogenic 
endpoints 

Non-carcinogenic endpoints 

Cobalt and inorganic 
cobalt compounds 

Lung cancer 

Restricted lung disease 
Upper airway irritation 

124 

 
 
 
 
Isoprene 

Liver cancer 

Polycyclic aromatic 
hydrocarbons 
(PAHs) 
Welding fume 

Lung cancer 

Lung cancer 

1,4-dioxane 

Degeneration of olfactory epithelium 
Degeneration of spinal cord white matter 
Developmental toxicity 
Male reproductive toxicity (infertility) 

Kidney effects 
Liver effects 
Local irritation: effects in nasal cavity 

The  key  model  inputs  are  summarised  below.  These  are  used  to  estimate  the  number  cases  of  ill 
health  over  the  relevant  period.  The  exposed  workforce  is  divided  into  several  bands  which  are 
characterised  by  variations  in  some  of  these  inputs  and  for  which  the  incidence  of  ill  health  is 
estimated separately and subsequently aggregated into totals for each substance. 

Parameter 
Exposure-risk/dose-
response relationship 
Exposed workforce 
Exposure concentration 

Trends 

Source: RPA (2024) 

Table 37 - key model inputs 

Explanation 

Exposure-Risk Relationship (ERR) for cancer effects or Dose-
Response Relationship (DRR) for non-cancer effects 
Number of workers exposed  
For OELs: 8-hr TWA (time-weighted average) that the workers are 
exposed to (real concentration, i.e. if personal protective equipment 
(PPE) is currently worn, the measured concentrations are adjusted to 
take into account PPE where possible) 
For STELs: 15-min peak exposure (real concentration after taking 
into account PPE) 
For BLVs: the concentration of the relevant substance or metabolite 
in the relevant biological media such as blood or urine 
Past and future trends in numbers of workers exposed and/or 
exposure concentrations  

In  addition  to  the  key  inputs  set  out  above,  the  model  relies  on  a  range  of  assumptions  that 
determine when the relevant effect occurs or is diagnosed, the nature and severity of its effects, and 
how  long  these  effects  (or  their  consequences)  last.    These  assumptions  differ  by  substance  and 
health outcome. Some of these  assumptions are  a simplification of complex real-life scenarios or 
best estimates (where authoritative evidence could not be identified from available literature).  

The key areas in which assumptions had to be made to enable the model to estimate and monetise 
the incidence of ill-health over the relevant assessment period are set out in the table below. 

Table 38 - further assumptions for the estimation of the year of occurrence of the relevant effects and their 
monetisation 

Parameter 
Onset of the disease 
MinEx 
MaxEx 

Explanation 

The minimum exposure duration required to develop the endpoint 
The time needed to reach the maximum risk (i.e. after the MaxEx has been 

125 

 
 
 
 
 
 
 
 
 
Lat 
Dist 

reached, the risk does not increase further) 
The latency with which the effect is demonstrated 
The distribution of cases over the period between MinEx and the MaxEx: 
the default assumption is a linear accumulation of risk over the relevant 
period 

The effects of the disease 
Mortality 
Severity 

Value of a case  

Source: RPA (2024) 

Mortality rate as a result of the relevant condition 
The typical severity (mild to severe) of the relevant outcome – where a 
range of severities is expected, a weighted average has been estimated 
Monetary value of a case taking into account the direct, indirect, and 
intangible costs estimated relying either on a) Willingness to Pay (WTP) for 
a case of mortality or morbidity or b) monetised Disability Adjusted Life 
Years (DALYs) 

The  model  provides  an  approximation  of  the  order  of  magnitude  of  the  expected  impacts.  The 
outputs of the model include: 

•  The  number  of  new  cases  for  each  health  endpoint  assigned  to  a  specific  year  in  the 

assessment period; 

•  The Present Value (PV) of the direct, indirect, and intangible costs of these cases. 

3.2. 

Inputs 

3.2.1.  ERRs and DRRs 

The risk of developing the relevant effects is estimated by combining exposure concentrations with 
the ERRs (for cancer) and DRRs (for non-cancer endpoints).  

3.2.2.  ExW: exposed workforce  

As a default value, in the previous impact assessment it was assumed that there is a staff turnover of 
5% per year corresponding to an average employment in a sector of 20 years. The 5% per year is 
lower than the turnover ratios in most of the published literature and Eurostat, which are typically 
derived  at  the  level  of  individual  companies  rather  than  sectors.  However,  it  is  common  that 
workers would continue to work within similar type of jobs for a major part of their work life, but it 
is  uncertain  to  what  extent  they  would  continue  with  a  job  function  with  a  specific  exposure 
situation.  

A meta study189 of exposure in the hard-metal industry covering 32,354 workers reported that 30.4 
% were employed for less than 1 year, 24.4% had an employment duration of 1-4 years, 26.7% had 
5-19 years and 18.4% at least 20 years. If it is assumed that the fourth group covers the 20-40 years 

189  Marsh  et  al.  (2017),  Mortality  Among  Hardmetal  Production  Workers:  Pooled  Analysis  of  Cohort  Data  From  an 
International Investigation.. Journal of Occupational and Environmental Medicine, December, 59(12), pp. e342-e364. 

126 

 
 
 
 
 
 
period, the average exposure time would be about 12.5 years. According to a study190 on a cohort of 
workers  in  the  French  stainless  steel  industry,  comprising  4,897  subjects,  the  mean  duration  of 
employment was of 17 years.  

It is common that in some industries such as construction, workers continue to work within in the 
same  industry  for  a  major  part  of  their  work  life,  but  it  is  uncertain  to  what  extent  they  would 
continue  with  a  job  function  with  a  specific  exposure  situation.    It  was  assumed  for  this  impact 
assessment that this applies to welders, particularly because the demand for welders across the EU 
is high and appears likely to remain so for many years.  It also seems likely to be correct for several 
of  the  other  heavy  industries,  vehicle  repair,  and  firefighting  that  apply  to  cobalt,  PAHs  and 
isoprene.    Although  this  assumption  may  not  be  as  appropriate  for  the  sectors  relevant  to  1,4-
dioxane as for the sectors relevant to the other substances assessed within this impact assessment, 
the  default  staff  turnover  of  5%  per  years  used  in  the  previous  impact  assessment  is  retained  for 
purposes of consistency.  

3.2.3.  Exposure concentrations  

For  each  substance,  one  or  more  exposure  scenarios  have  been  modelled  based  on  data  sourced 
from  literature  and  consultation  –  these  scenarios  are  used  for  the  estimation  of  the  costs  and 
benefits (cost savings from reduced ill-health) of the policy options. 

The number of workers exposed at levels of relevance for the assessment of establishing an OEL is 
derived from consultation with relevant companies and industry associations, databases, literature, 
workers' associations and other sources.  For each of the relevant sectors, distributions of workers 
over exposure levels  were established.  In general,  it is assumed that the exposure concentrations 
are lognormal distributed EN689 European Standards (2019), and exposure data collected for this 
study  are  fitted  to  a  lognormal  distribution  for  which  the  key  parameters  such  as  the  50th,  75th, 
90th  and  95th  percentiles  are  estimated  (please  note  that  these  parameters  may  differ  between 
substances).   

When the main parameters (different percentiles) of a lognormal distribution have been estimated, 
the  exposed  workforce  is  divided  into  several  (typically  five)  exposure  bands  and  each  of  these 
exposure bands is assigned a representative exposure or biomonitoring concentration.  For the band 
with  the  lowest  exposure,  the  highest  exposure  concentration  in  that  band  is  typically  taken  as 
representative.  For the highest exposure band, the geometric mean (GM) of the concentrations in 
that band is taken as representative. For the intervening bands, the arithmetic mean (AM) of each 
band is taken as representative. 

Exposure concentrations estimated based on data from literature or consultation have been sense-
checked  against  existing  OEL  and  BLVs  in  EU  Member  States  to  ensure  that  they  are 
representative  of  present-day  exposure  which  is  expected  to  be  defined  by  national  legal 
requirements.  Consequently, it has not been necessary to take the existing OELs into account when 
estimating the effects of introduction of a new OEL/BLV. 

190 Moulin, J. et al., (2000). Risk of lung cancer in workers producing stainless steel and metallic alloys. International 
Archives of Occupational and Environmental Health, Volume 73, pp. 171-180. 

127 

 
 
3.2.4.  Values used in the benefits and costs models  

In both the benefits and costs models, the exposed workers or enterprises with exposed workers are 
split  into  five  percentile  groups.  The  exposure  level  assumed  to  be  experienced  by  this  group  is 
calculated as shown in the table below.  

Table 39 - calculation of exposure levels used in benefits and costs models 

Percentiles 

0 - 50 
51 - 75 
76 - 90 
91 - 95 
96 - 100 
Source: RPA (2024) 

Proportion of workers 
or enterprises 
50% 

25% 

15% 

5% 

5% 

Calculation for exposure level assumed for 
modelling 

Median or 50th percentile 

Arithmetic mean of 50th and 75th percentiles  

Arithmetic mean of 75th and 90th percentiles 

Arithmetic mean of 90th and 95th percentiles 

Geometric mean of 95th and 100th percentiles 

3.2.5.  The effect of introducing an OEL/BLV 

The background for the models used is the approach set out in EN 689:2018: “Workplace exposure. 
Measurement  of  exposure  by  inhalation  to  substances.  Strategy  for  testing  compliance  with 
occupational  exposure  limit  values”.    This  standard  is  widely  relied  on  when  determining 
compliance  with  an  OEL.    A  summary  of  the  approach  in  this  standard  is  provided  in  the  box 
below. 

Box 1 - summary of the approach in EN689 

128 

 
 
In the standard, compliance with an OEL is determined by either a screening test or a 
test of compliance. 

Screening test 

The screening test requires three to five exposure measurements on workers belonging 
to a SEG.  

a) If all results are below:  

1) 0.1 * OEL for a set of three exposure measurements or,  
2) 0.15 * OEL for a set of four exposure measurements or,  
3) 0.2 * OEL for a set of five exposure measurements  
then it is considered that the OEL is respected: Compliance. 

b) If one of the results is greater than the OEL, it is considered that the OEL is not 
respected:  Non-compliance.  In  case  that  the  first  measurement  result  is  above  the 
OEL, it is not necessary to perform any additional measurements.  

c)  If  all  the  results  are  below  the  OEL  and  a  result  above  0.1  *  OEL  (set  of  three 
results) or 0.15 * OEL (set of four results) or 0.2 * OEL (set of five results) it is not 
possible  to  conclude  on  compliance  with  the  OEL.  No-decision.  In  this  situation 
additional exposure measurements shall be carried out in order to apply the test based 
on  the  calculation  of  the  confidence  interval  of  the  probability  of  exceeding  the 
OELV, as specified below.  

Test of compliance with the OEL 
According to the standard, the appraiser shall select a statistical test of whether the 
exposures in a similar exposure group (SEG) comply with the OEL. The test shall 
measure, with at least 70 % confidence, whether less than 5 % of exposures in the SEG 
exceed the OEL. 

Source: RPA (2024), based on EN689 European Standards (2019) 

EN689:2019 requires that “less than 5% of exposures exceed the OEL” - this can be interpreted as 
meaning  that  5%  of  the  measurements  may  be  above  the  OEL.    As  a  result,  compliance  in  the 
model  developed  for  this  study  is  taken  to  mean  that  the  95th  percentile  (P95)  of  the  exposure 
distribution is at or below the OEL or BLV.  

Consequently, the effects of lowering an OEL or BLV are modelled as follows: 

•  The 95th percentile of the current exposure distribution (air or biomonitoring concentrations) 
is compared with the target OEL/BLV and a reduction factor is estimated to show by how 
much the 95th percentile of the distribution needs to reduce.  
It is expected that the whole exposure distribution is reduced by this factor and the reduction 
factor  is  thus  applied  to  all  exposure  bands.  This  reflects  the  expectation  that  there  is 
variability  even  between  measurements  carried  out  for  workers  in  similar  exposure 
situations.  

• 

•  No health effects are expected to occur when exposure has been reduced below a threshold. 

129 

 
 
This means that, even when the OEL/BLV has been lowered to a value that is the threshold for the 
relevant  health effects,  some ill  health can still be expected to  occur because some exposure  will 
still exceed the P95(=OEL/BLV) value. 

3.3.  Assumptions 

3.3.1.  Onset of the disease  

(a)  MinEx & MaxEx – The minimum and maximum exposure duration required do 

develop the endpoint 

No cases arise until the minimum exposure duration required to develop the endpoint (MinEx) has 
been  reached  (see  table  below).  No  further  increase  in  risk  is  assumed  to  arise  with  increasing 
exposure time after the expiration of the MaxEx.  

Table 40 - minimum and maximum exposure duration to develop a condition (MinEx and MaxEx) 

Substance 

Endpoint (ERR or DRR) 

MinEx 
(years) 

MaxEx (years) 

Cobalt and inorganic 
cobalt compounds 

Isoprene 

Polycyclic aromatic 
hydrocarbons (PAHs) 

Welding fume 
1,4-dioxane 

Source: RPA (2024) 

Lung cancer 
Restricted lung disease 
Upper airway irritation 
Liver cancer 
Degeneration of olfactory 
epithelium 
Degeneration of spinal cord white 
matter 
Lung cancer 
Developmental toxicity 
(miscarriage) 
Male reproductive toxicity 
(infertility) 
Lung cancer 
Kidney effects 
Liver effects 
Local irritation: effects in nasal 
cavity 

0 
0 
0 
0 
0 

0 

0 
0 

0 

0 
0 
0 
0 

(b) Dist – The distribution of cases over time 

40 
1 
0 
40 
1 

1 

40 
0 

0 

40 
1 
1 
0 

Valuing the cost  of  work-related illness involves applying discounted costs to  future cases which 
requires  that  the  estimated  cases  over  the  period  between  MinEx  and  MaxEx  are  assigned  to 
specific years. 

The  distribution  of  cases  between  start  of  exposure  and  the  MaxEx  is  modelled  based  on  the 
assumption  of  a  linear  accumulation  of  risk  over  time  with  the  maximum  risk  being  achieved  at 
MaxEx.  The risk in a given year thus equals Risk=Risk at MaxEx/(MaxEx-MinEx). It is assumed 
that the distribution is linear, i.e. 1/40 of the excess risk arises in Year 1 and 100% of the excess 
risk predicted for a specific exposure concentration arises by Year 40. 

130 

 
 
For  cancer  endpoints,  the MaxEx is  typically the full working  life, i.e. 40 years.   For non-cancer 
endpoints, the MaxEx can be shorter, and the full risk estimated by the DRR can arise sooner than 
at the end of a person’s working life.  This is illustrated in the figure below.  

Figure 5 - Non-cancer endpoints – fraction affected over time - example with a MaxEx of 2 years 

Source: RPA (2024) 

(c)  Lat – Latency  

The estimated risk is combined with latency to estimate the specific year of diagnosis of a case. The 
below  tables  provide  the  latency  periods  assumed  for  cancer  and  non-cancer  endpoints  for  the 
purpose of this impact assessment. 

Table 41 - latency periods of cancer endpoints 

Substance 

Cobalt and inorganic cobalt 
compounds 
PAHs 
Welding fume 
Isoprene 
Source: RPA (2024) 

Endpoint 

Lung cancer 

Latency (years) 
30 

Liver cancer 

18 

 Table 42 - latency periods of non-cancer endpoints 

Substance 

Endpoint 

Latency 
(years) 

Cobalt and inorganic cobalt 
compounds 
Isoprene 

PAHs 

1,4-dioxane 

Restricted lung disease 
0 
Upper airway irritation 
0 
0 
Degeneration of olfactory epithelium 
Degeneration of spinal cord white matter  0 
0 
Developmental toxicity (miscarriage) 
0 
Male reproductive toxicity (infertility) 
0 
Kidney effects 

131 

 
 
 
 
 
 
Liver effects 
Local irritation: effects in nasal cavity 

0 
0 

Source: RPA (2024) 

3.3.2.  The effects of the disease 

(a)  MoR – mortality rate  

Mortality rate as a result of the relevant condition is important since different monetary values are 
applied to mortality and morbidity. The mortality rates used in the model are given below.   

Substance 

Cobalt and inorganic 
cobalt compounds 

Isoprene 

Polycyclic aromatic 
hydrocarbons (PAHs) 

Welding fume 
1,4-dioxane 

Source: RPA (2024) 

Table 43 - mortality rate over 5 years 

Endpoint 

Lung cancer  
Restricted lung disease 
Upper airway irritation 
Liver cancer 
Degeneration of olfactory epithelium 
Degeneration of spinal cord white 
matter 
Lung cancer 
Developmental toxicity (miscarriage) 
Male reproductive toxicity 
(infertility) 
Bladder cancer* 
Lung cancer 
Kidney effects 
Liver effects 
Local irritation: effects in nasal 
cavity 

Mortality rate 
80% 
0 
0 
90% 
0 
0 

80% 
0 
0 

50% 
80% 
0 
0 
0 

(b) Treatment period  

The treatment periods used in the model are given below. The end of the treatment period signifies 
either a fatal or illness-free outcome. 

Table 44 - treatment period 

Substance 

Endpoint 

Cobalt and inorganic 
cobalt compounds 

Isoprene 

Lung cancer  
Restricted lung disease 
Upper airway irritation 
Liver cancer 

Degeneration of olfactory epithelium 
Degeneration of spinal cord white matter 

Polycyclic 

aromatic  Lung cancer 

Treatment 
period (years) 
5 
1 
1 
5 

1 
1 
5 

132 

 
 
 
 
hydrocarbons (PAHs) 

Welding fume 
1,4-dioxane 

Source: RPA (2024) 

Bladder cancer 
Developmental toxicity (miscarriage) 
Male reproductive toxicity (infertility) 

Lung cancer 
Kidney effects 
Liver effects 
Local irritation: effects in nasal cavity 

3 
20 
1 

5 
1 
1 
1 

(c)  Monetary value of the relevant endpoint  

The approach to the monetisation of ill health effects is based on the following approach. 

Table 45 - cost saving framework  

Notes 

Cost of medical treatment, including hospitalisation, 
surgery, consultations, radiation therapy, 
chemotherapy/immunotherapy, etc. 
Opportunity cost of unpaid care (i.e. the monetary 
value of the working and/or leisure time that relatives 
or friends provide to those with cancer)  
Cost to employers due to insurance payments and 
absence from work 
The economic loss to society due to premature death 

Loss of earnings and output due to absence from work 
due to illness or treatment 
A monetary value of the impact on quality of life of 
affected workers 

Category 
Direct 

Cost 

Healthcare 

Informal care191 

Cost for employers 

Indirect  Mortality – productivity 

loss 
Morbidity – lost working 
days 
Intangible  Approach 1 WTP: 

Mortality 
Approach 1 WTP: 
Morbidity 
Approach 2 DALY: 
Mortality 
Approach 2 DALY: 
Morbidity 

Source: RPA (2024) 

Two  approaches  to  the  monetisation  of  intangibles  have  been  adopted  for  the  purposes  of  this 
study:  

•  Method 1: Application of WTP values to each case (differentiating between mortality and 

morbidity); and 

191 A decision has been taken to include informal care costs in this analysis even though some elements of these costs 
may also have been included in individuals’ willingness to pay values to avoid a future case of ill health. This decision 
may result in an overestimate of the cost savings (benefits) as generated by this study.  

133 

 
 
 
 
 
•  Method 2: Use of DALYs (Disability adjusted life year) and their monetisation. 

The  only  difference  between  Method  1  and  Method  2  is  the  way  in  which  avoided  cases  of  ill 
health are monetised.  Both methods monetise the same number of avoided cases of ill health. 

Cost savings for workers and families 

The direct and indirect resource costs are estimated using market-based information, for example, 
data on health care costs, and estimates of lost output (i.e. the value of a day of work). 

Added to these are the ‘human’ or intangible costs associated with a case, which are measured in 
terms  of an individual’s willingness to  pay for the reduction in  the risk of mortality  or morbidity 
(Approach 1) or monetised DALYs (Approach 2).  

Under Approach 1, the most commonly used means of estimating individuals’ WTP for a reduction 
in  the  risk  of  an  illness  is  through  the  use  of  experimental  markets  and  survey  techniques  (e.g. 
contingent  valuation  or  contingent  ranking  studies)  to  directly  elicit  individuals’  WTP  for  a 
reduction in the risk of death or morbidity.  

The key measures are the value of a statistical life – a VSL – and the value of a case of morbidity 
(value  of  cancer  morbidity  VCM  or  value  of  morbidity  VM  in  non-cancer  cases).  The  VSL  is 
essentially  a  measure  of  a  change  in  the  risk  of  fatality,  where  this  is  found  by  determining 
individuals’  willingness  to  pay  for  a  small  change  in  risk  which  is  then  summed  across  the 
population at risk.  None of the non-cancer endpoints have a mortality rate and therefore no VSLs 
are given for non-cancer endpoints. 

Values for value of statistical life and value of cancer morbidity required for cancer endpoints by 
Method 1 are summarised in the box below. Value of morbidity required for non-cancer endpoints 
by Method 1 are summarised in table 46. 

Box 2: Method 1 and cancer – Value of statistical life and value of cancer morbidity 

Willingness to Pay (WTP) for avoided mortality and morbidity 

Value of Statistical Life – VSL: With regard to the value of a statistical life, the figure adopted is 
€4,710,000. This is based on Better Regulation Tool #32. Here, a range from €3.5 to 5 million is 
suggested.  We  use  the  mid-point  (€4,250,000),  updated  from  2012  to  2021  prices  used  in  Better 
Regulation Tool #32 using Eurostat’s GDP deflator. 

Value of Cancer Morbidity -VCM: Not  all  cancers  will  lead  to  death  and  it  will  therefore  be 
important to also include the willingness of individuals to pay to avoid a case of non-fatal cancer.  
The available literature offers a broad range of estimates for the willingness to pay to avoid a non-
fatal cancer. A value of €410,000 (2012 prices) has been adopted as the willingness to pay to avoid 
a non-fatal case of cancer192.  This figure has been updated to 2021 prices: €455,000. 

Source: RPA (2024), based on ECHA’s WTP reference mentioned in BR tool #32 

192 ECHA 2016 Valuing selected health impacts of chemicals, 2016, 
https://echa.europa.eu/documents/10162/17228/echa_review_wtp_en.pdf/dfc3f035-7aa8-4c7b-90ad-4f7d01b6e0bc 

134 

 
 
 
 
Table 46 - method 1 and non-cancer – Value of morbidity - VM  

Endpoint 

Comment 

Restricted lung disease 

Upper airway irritation 

Degeneration of olfactory 
epithelium 

Calculated based upon the disability weight 
of 0.033 and a DALY of one year valued at 
€100,000 

Based on upper values for WTP for skin 
irritation193 

This value is based on the fact that a person 
irreversibly loses, partially or completely, 
one of the senses, which can result in adverse 
psychological and social impacts. 

Value of morbidity - 
VM 
€3,300 

€700 

€32,000 

Degeneration of spinal 
cord white matter 

This value is based upon the adjusted values 
for Parkinson’s disease 

€1,000 

Five WTP thresholds for a QALY gained 
were used: 0, 20,000, 40,000, 60,000, and 
80,000 euro194. In The Netherlands, the 
disability weight of Parkinson’s disease is 
0.497 (scale, 0-1),21 and this corresponds to 
a WTP per QALY of nearly 40,000 euros.  
The disability weight for degeneration of 
spinal cord white matter is 0.01, which is 
proportional to a WTP per QALY of nearly 
805 euros.  As these are figures for 2015, the 
value has been adjusted for inflation to 
€1,000. 

Based on WTP of couples with infertility 
problems to conceive of €22,000 at 2012195.  
This value covered early and later 
miscarriages and stillborns, and was therefore 
reduced by two thirds, and adjusted for 
inflation.  

€9,600 

Developmental toxicity 
(miscarriage) 

193 ECHA (2016), op. cit.  
194 Sturkenboom, Ingrid & Hendriks, Jan & Graff, Maud & Adang, Eddy & Munneke, Marten & Nijhuis-van der 
Sanden, Maria & Bloem, Bas. (2015). Economic evaluation of occupational therapy in Parkinson's disease: A 
randomized controlled trial: Economic Evaluation OTIP Study. Movement Disorders. 30. 10.1002/mds.26217. 
https://www.researchgate.net/publication/275057433_Economic_evaluation_of_occupational_therapy_in_Parkinson's_
disease_A_randomized_controlled_trial_Economic_Evaluation_OTIP_Study/citation/download  
195 ECHA (2017):  32nd Meeting of the Committee for Socio-Economic Analysis, 6-15 September 2016, Helsinki, 
Finland.  SEAC/32/2016/05.2 Rev1+ 
https://echa.europa.eu/documents/10162/13637/seac_reference_wtp_values_en.pdf/403429a1-b45f-4122-ba34-
77b71ee9f7c9  

135 

 
 
 
Male reproductive toxicity 
(infertility) 

Kidney effects 

Liver effects 

Based on WTP of couples with infertility 
problems to conceive of €22,000 at 2012196, 
adjusted for inflation. 

Based on WTP for temporary kidney effects 
€532 in 2012, taken as €1,000 for 2021, as 
unclear just how temporary these effects 
are197. 

Liver effects (temporary) taken as being the 
same as kidney effects198. 

Local irritation: effects in 
nasal cavity 

Based upon WTP for skin irritation, twice a 
year for 10 years, €447199. 

€30,000 

€1,000 

€1,000 

€500 

Source: RPA (2024) 

Method 2 is summarised below. 

Box 3 - Method 2 - DALYs 

One DALY can be thought of as one lost year of ‘healthy life’, and the burden of disease can be 
thought of as a measurement of the gap between current health status and an ideal situation where 
everyone lives into old age, free of disease and disability.  

DALYs were developed to reflect the sum of years of life lost (YLL) due to premature mortality 
and years lived in  disability/disease (YLD). YLLs are calculated as the number of deaths  at  each 
age  multiplied  by  the  standard  life  expectancy  for  each  age.  YLDs  represent  the  number  of 
disease/disability  cases  in  a  period  multiplied  by  the  average  duration  of  disease/disability  and 
weighted by a disease/disability factor.  

DALYs take into account  the number of years of life lost due to either premature mortality or to 
living in a less than perfect health state, and are calculated as follows:  

𝐷𝐴𝐿𝑌 = 𝑌𝐿𝐷 + 𝑌𝐿𝐿 

YLD, which stands for Years Lived with Disability, is calculated as follows:  

𝑌𝐿𝐷  =  𝑁𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑐𝑎𝑠𝑒𝑠 ∗ 𝐴𝑣𝑒𝑟𝑎𝑔𝑒 𝑑𝑖𝑠𝑒𝑎𝑠𝑒 𝑑𝑢𝑟𝑎𝑡𝑖𝑜𝑛 ∗ 𝐷𝑖𝑠𝑎𝑏𝑖𝑙𝑖𝑡𝑦 𝑤𝑒𝑖𝑔ℎ𝑡 

YLL, which stand for Years of Life Lost due to premature death, is calculated as:  

𝑌𝐿𝐿 = 𝑁𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑑𝑒𝑎𝑡ℎ𝑠 ∗ 𝐿𝑖𝑓𝑒 𝑒𝑥𝑝𝑒𝑐𝑡𝑎𝑛𝑐𝑦 𝑎𝑡 𝑎𝑔𝑒 𝑜𝑓 𝑑𝑒𝑎𝑡ℎ 𝑖𝑛 𝑦𝑒𝑎𝑟𝑠 

Source: RPA (2024) 

Years of life lost dur to premature mortality  

196 ECHA (2017), op. cit. 
197 ECHA (2016), op. cit.  
198 ECHA (2016), op. cit. 
199 ECHA (2016), op. cit. 

136 

 
 
 
The average life expectancy used for the  calculations  in  the model is  82 years.  In the absence of 
other information and taking into account the age distribution of cancer deaths, it is assumed that a 
typical cancer death occurs at the age of 60 and the number of years lost is thus 22. 

Average disease duration after treatment  

The average disease duration after treatment is given below. 

Table 47 – average disease duration after treatment  

Substance 

Endpoint 

Lung cancer  
Restricted lung disease 
Upper airway irritation 
Liver cancer 
Degeneration of olfactory epithelium 
Degeneration of spinal cord white 
matter 
Lung cancer 
Bladder cancer 
Developmental toxicity (miscarriage) 
Male reproductive toxicity (infertility) 

Lung cancer 
Kidney effects 
Liver effects 
Local irritation: effects in nasal cavity 

Cobalt and inorganic cobalt 
compounds 

Isoprene 

Polycyclic  aromatic  hydrocarbons 
(PAHs) 

Welding fume 
1,4-dioxane 

Source: RPA (2024) 

Disability weight 

Disease duration after 
treatment (years) 
5 
30 
1 
5 
30 
30 

5 
10 
1 
1 

5 
1 
1 
1 

The  disability  weights  derived  in  the  European  Disability  Weights  project  are  used  for  cancer  as 
these are most relevant  to the European population. For the other effects, disability weights have 
been estimated in the substance specific reports200. 

Table 48 – disability weights used in this impact assessment 

During treatment 
0.005 

After treatment 
0.005 

Endpoint 

Degeneration of olfactory 
epithelium 
Degeneration of spinal cord white 
matter 
Developmental toxicity 
(miscarriage) 
Kidney effects 
Liver cancer 
Liver effects   
Local irritation: effects in nasal 
cavity 
Lung cancer  

200 RPA (2024), op. cit., substance-specific reports  

0.01 

0 

0 
0.049 
0 
0 

0.515 

0.01 

0.114 

0.004 
0.45 
0.016 
0.006 

0.265 

137 

 
 
 
 
 
Male reproductive toxicity 
(infertility) 
Restricted lung disease 
Upper airway irritation 
Bladder cancer* 
Source: RPA (2024) 

Cost savings for employers 

0.008 

0.033 
0.007 
0.426 

0 

0.019 
0.007 
0.123 

Introducing limit values has obvious cost savings for workers, namely in terms of their health but 
also,  indirectly,  on  their  earnings.  Employers  will  also  accrue  cost  savings  from  their  employees 
being less at risk of work-related illness. Such cost savings include: 

•  Higher  labour  productivity  resulting  from  reductions  in  absenteeism  and  associated 

production losses; 

•  Reduced administrative or legal costs relating to employees who are ill;  
•  Reduced insurance premiums; 
•  Reduced reputational risks; and 
•  Reduced sick leave payments. 

A study commissioned by DG Employment (2011) considers the socio-economic costs of accidents 
and ill-health relating to work and the cost savings to employers of implementing effective health 
and safety management policies. The report estimates that the cost to employers for a single case of 
a  high-severity  accident  or  disease  is  €11,760.  This  figure  is  based  on  data  pertaining  to  cost 
categories such as: 

Based on a study considering the socio-economic costs of accidents and ill-health relating to work 
and  the  cost  savings  to  employers  of  implementing  effective  health  and  safety  management 
policies201,  the  cost  to  employers  for  a  single  case  of  a  high-severity  accident  or  disease  was 
updated to 2021202 resulting in €13,200. 

No values of cost savings for employers are available for non-cancer endpoints, but there should be 
savings for employers with workers suffering from degeneration of spinal cord white matter (which 
is similar to mild Parkinson’s disease) and local irritation caused by effects in nasal cavity (which is 
similar  to  a  bad  cold).    Based  upon  the  value  of  €13,200  taken  for  cancer,  €5,000  and  €500  are 
taken for these endpoints respectively, because the impacts are constant but minor for degeneration 
of  spinal  cord  white  matter  (or  mild  Parkinson’s  disease),  and  occasional  and  minor  for  local 
irritation caused by effects in nasal cavity. 

It is recognised that companies may also incur court/PR costs and these may not be fully reflected 
in the estimate above.  However, there are insufficient data to estimate the avoided court costs for 
compensation due to ill health and/or and cost of bad publicity. 

201 DG EMPL, 2011. Socio-economic costs of accidents at work and work-related ill health. Available at: 
http://ec.europa.eu/social/BlobServlet?docId=7416&langId=en 
202  Eurostat’s  GDP  deflator  (Dataset:  GDP  and  main  components  (output,  expenditure  and  income)  [namq_10_gdp]) 
was used to adjust the estimate from 2011 to 2021 prices.  The adjustment factor used is 1.122. 

138 

 
 
 
Cost savings for workers 

Individuals  will  incur  costs  associated  with  their  inability  to  work  in  terms  of  a  loss  of  earnings, 
including losses linked to days of treatment as well as days off due to illness.  Luengo-Fernandez et 
al.203 developed estimate of the magnitude of such costs by Member State in terms of an average 
cost per fatal or non-fatal cancer.  These included what are referred to as ‘productivity losses’ due 
to early death and then lost working days due to morbidity effects.  Across all cancers, an average 
figure  of  €5,047  (rounded  to  €5,000)  is  given  for  productivity  losses  and  €1,118  (rounded  to 
€1,000) for the costs associated with lost working days due to morbidity effects (with these based 
on lost wages as the measure of lost output).  

Workers  will  also  incur  costs  of  unpaid  care  (the  monetary  value  of  the  working  and/or  leisure 
time)  provided  by  relatives  or  friends  to  those  with  cancer.  This  care  costs  an  average  of 
approximately €3,000 annually. 

Cost savings for the public sector – cost of healthcare  

Cancer  

Each  lung  cancer  patient  costs  the  UK  healthcare  system  £9,071  annually204.    Hence,  inflated  to 
2020 (from 2012) and converted to euros, the cost would be €11,500.   

The median cost per liver cancer patient over 2 years was $9,065205. Hence, one year costs inflated 
to 2020 (from 2016) and converted to euros would be €5,500. 

In  the  UK,  the  3-year  average  cost  per  for  non-muscle  invasive  bladder  cancer,  recurrence  and 
progression to muscle invasive bladder cancer is approximately £5000 per year206, which converted 
to euros the cost would be roughly €5,600.  

Table 49 – estimates of the annual healthcare costs per cancer patient 

Cancer 

Healthcare costs (€) 

Lung cancer  
Liver cancer 
Bladder cancer* 
Source: RPA (2024) 

€11,500 
€5,500 
€5,600 

203 Luengo-Fernandez et al. (2013) Economic burden of cancer across the European Union: a population-based cost 
analysis. The Lancet. Oncology, 14(12), pp. 1165-1174. Available at: 
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70442-X/fulltext 
204 (Cancer UK, 2012)' Lung cancer UK price tag eclipses the cost of any other cancer 
https://news.cancerresearchuk.org/2012/11/07/lung-cancer-uk-price-tag-eclipses-the-cost-of-any-other-cancer  
205 Cullen K, Jones M, Pockett RD, Burton A, Cross TJS, Rowe IA, Paley L, Tataru D, Alexander G, Marshall A, 
Fitzsimmons D. Cost of hepatocellular carcinoma to the national health service in England: a registry-based analysis. 
BMJ Open Gastroenterol. 2023 Feb;10(1):e000998. doi: 10.1136/bmjgast-2022-000998. PMID: 36810207; PMCID: 
PMC9945044.  
206 Cox E, Saramango P, Kelly J, Porta N, Hall E, Tan WS, Sculpher M, Soares M (2020) Effects of Bladder Cancer on 
UK Healthcare Costs and Patient Health-Related Quality of Life: Evidence From the BOXIT Trial. Clin Genitourin 
Cancer. 2020 Aug;18(4):e418-e442. doi: 10.1016/j.clgc.2019.12.004. Epub 2019 Dec 14. PMID: 32144049; PMCID: 
PMC7427321. 

139 

 
 
 
 
Non cancer 

A  mild  Parkinson’s  disease  is  used  as  a  proxy  for  degeneration  of  spinal  cord  white  matter.  
According to Weir et al.207, mean costs attributable to Parkinson’s disease rose steadily from £2,471 
per patient  in  the first  year following diagnosis  up to  £4,004 per patient  in  year ten.  As the first 
year of Parkinson’s disease is  considered mild,  the healthcare  costs attributable to  this period are 
used  for  costs  associated  with  degeneration  of  spinal  cord  white  matter,  which,  inflated  to  2020 
(from 2013) and converted to Euros, would be approximately €3,100.   

The  cost  of  treating  developmental  toxicity  has  been  derived  from  UK  2021  NHS  data  on 
miscarriage208 and an academic paper modelling the economic costs of stillbirth (NIHR, 2017). The 
study  team  have  calculated  the  average  cost  of  miscarriage  as  £1,884  (approximately  €2,220  in 
2023),  and  the  average  cost  of  stillbirth  as  £4,200  (approximately  €4,850  in  2023).  As 
developmental  toxicity  refers  to  both  health  effects,  and  both  stillbirth  and  miscarriage  have 
varying degrees of severity and by extent, varying costs, the study team have taken an approximate 
median value of €3,500. 

The  cost  of  treating  male  infertility  varies  depending  on  the  severity  of  illness,  the  types  of 
treatment  available, and  personal  preferences to  repeat  treatment  campaigns. Cost  of treatment  of 
€1,400 is taken from values used in previous studies. 

As no treatment is available for degeneration of olfactory epithelium, upper airway irritation, local 
irritation: effects in nasal cavity, and liver effects, the cost of treatment has been set to €500 to only 
reflect visits to doctors for diagnosis.   

Restricted  lung  disease  and  kidney  effects  also  require  little  or  no  treatment,  and  the  cost  of 
treatment has been set to €1,000 to only reflect visits to doctors for diagnosis, and possibly a small 
amount of treatment. 

Table 50 – estimates of the annual healthcare costs per non cancer patient 

Non cancer 

Healthcare costs (€) 

Kidney effects 
Liver effects 
Restricted lung disease 
Upper airway irritation 
Local irritation: effects in nasal cavity 
Degeneration of olfactory epithelium 
Degeneration of spinal cord white matter 
Repro – women – miscarriage 
Repro – men - fertility 
Source: RPA (2024) 

€1,000 
€500 
€1,000 
€500 
€500 
€500 
€3,100 
€3,500 
€1,400 

207 Weir S, Samnaliev M, Kuo TC, Tierney TS, Walleser Autiero S, Taylor RS, Schrag A. Short- and long-term cost 
and utilization of health care resources in Parkinson's disease in the UK. Mov Disord. 2018 Jul;33(6):974-981. doi: 
10.1002/mds.27302. Epub 2018 Mar 30. PMID: 29603405 https://pubmed.ncbi.nlm.nih.gov/29603405/  
208 Tommys, (2021) Key statistics about pregnancy and loss in the UK, https://www.tommys.org/baby-loss-
support/pregnancy-loss-statistics  

140 

 
 
 
3.4.  Bringing it all together  

The cost savings (benefits) that have been estimated for each substance are summarised below. 

Table 51 - costs considered 

Category 

Cost 

Notes 

Direct 

Indirect 

Intangible 

Source: RPA (2024) 

Ch 
Ci 
Ce 
Cp 
Cl 
Cvsl 
Cvsm 

Cdaly 
Ch 

Healthcare 
Informal care 
Total cost to an employer 
Productivity loss due to mortality 
Lost earnings due to morbidity 
Value of statistical life 
Value of cancer morbidity/value of statistical 
morbidity 
Value of DALYs 
Healthcare 

The total avoided cost of ill health is calculated using the following two methods: 

Method 1: Ctotal= Ch+Ci+Ce+Cp+Cvsl+Cvsm 

Method 2: Ctotal= Ch+Ci+Ce+Cp+Cl+Cdaly 

Cl is not considered under Method 1 since Cvsm may already include these costs. 

In terms of assigning the cost savings (benefits) to the different stakeholder groups, the table below 
provides an overview of who bears the costs quantified in this study. 

Table 52 - quantified costs and stakeholder groups 

Stakeholder group 
Workers/family 

Costs 
Ci, Cl, Cvsl, Cvcm, 
Cdaly 

Governments 

Employers 
Source: RPA (2024) 

Ch, part of Cp (loss 
of tax revenue), part 
of Cl (loss of tax 
revenue) 
Ce, Cp 

Method of summation 

Method 1: 
CtotalWorker&Family=Ci+Cvsl+Cvcm 
Method 2: 
CtotalWorker&Family=Ci+(0.8*Cl)+Cdaly 
CtotalGov=Ch+0.2(Cp+Cl)209 

CtotalEmployer=Ce+0.8*Cp 

209  

Assumes 20% tax. 

141 

 
 
 
 
3.5.  Estimating the current burden of disease 

The current burden of disease (i.e. the number of cases diagnosed in 2023) is estimated on the basis 
of historical exposure. 

The  estimates  relate  to  the  sectors  where  exposure  to  the  substances  currently  occurs  and  do  not 
represent  the  total  burden  of  past  occupational  exposure  to  substances.  The  total  burden  from  all 
past  occupational  exposure  to  the  substances  would  require  consideration  of  sectors  where 
occupational  exposure  no  longer  takes  place  and  which  may  not  be  relevant  to  the  problem 
definition for this impact assessment. 

The  following  parameters  are  estimated  from  the  data  collected  through  literature  review  and 
consultation: 

•  Past rate of change in the exposed workforce; and 
•  Past rate of change in exposure concentrations. 

If an endpoint has a latency of 30 years, the model assumes that the cases diagnosed in 2023 reflect 
the risk that occurred 30 years ago in 1993, due to latency, and thus reflects the number of workers 
exposed in 1993 and the exposure concentrations in 1993.  

In  addition,  for  endpoints  with  latency  greater  than  zero,  there  will  continue  to  be  cases  due  to 
exposure in the last 40 years which occur in the next 40 years.  These are provided as the legacy 
burden of disease, together with the current burden of disease. 

3.6.  Estimating the future burden of disease 

The future burden of disease also takes into account the following parameters: 
Future rate of change in the exposed workforce; and 
Future rate of change in exposure concentrations. 

The FBD is always given as the cases over the next 40 years and is the number of cases generated 
by exposure in over the next 40 years (and not the number of cases actually happening in the next 
40  years).    Latency  may  cause  many  of  the  cases  caused  by  exposure  in  the  next  40  years, 
particularly of cancer, to occur beyond the 40 year period.  For this reason, the number of cases is 
not divided by 40 to indicate a number of cases per year as this would be misleading. 

3.7. 

Indirect benefits  

Member States may gain an indirect benefits from not having to define their own national OEL or 
BLV, as a result of the introduction of an EU limit value.  Defining a national OEL and/or BLV has 
associated  costs  for  Member  States  public  administrations  to  carry  out  impact  assessments  and 
define a suitable level of avoided risk.   

The data used are based on the assumption that all Member States without a national OEL and/or 
BLV would want to implement one and that all Member States with an existing OEL and/or BLV 
would want to revise them to ensure higher degrees of worker protection.  

The assumption if that the avoided cost of both OEL and BLV is the sum of both costs: there is no 
economy of scale for introducing both together. 

Table 53 – avoided costs related to the setting of national limit values 

142 

 
Member State situation 

Avoided cost per Member 
State 

Member States without an existing OEL and/or STEL 
Member  States  requiring  alteration  of  an  existing  OEL  and/or 
STEL 
Member States without an existing BLV 
Member States requiring alteration of an existing BLV 
Source: RPA (2024) 

€100,000 
€50,000 

€100,000 
€50,000 

4.  ESTIMATION AND MONETISATION OF HEALTH IMPACTS 

4.1. 

Introduction 

4.1.1.  Key features of the compliance cost model 

The key impact are the compliance costs for industry. It represents the costs for a group of similar 
companies incurred in reducing exposure to a target limit value based on an assumed sequence of 
RMM implementation which is determined by suitability, effectiveness, and cost. 

4.2.  Key model inputs and assumptions 

4.2.1.  Overview of key inputs 

The key model inputs include: 

•  Current exposure concentrations; 
•  OEL/BLV policy options; 
•  Assumptions about how compliance with the OEL/BLV is determined; 
•  Number  of  small,  medium  and  large  enterprises  at  each  of  the  current  exposure 

concentrations; 

•  Estimated  average  number  of  exposed  workers  and  workstations  using  the  substance  in  a 

company; 
•  Discount rates; 
•  Current RMMs; 
•  RMM effectiveness; 
•  Cost of RMMs (one-off and recurrent) as well as their average lifespan; and 
•  Suitability of specific RMM types for each of the sector. 

4.2.2.  Current exposure concentrations 

The key input is the distribution of exposure concentrations in each relevant industry sector. This 
involves dividing exposures into several (typically 5) exposure bands and assigning a representative 
concentration to each exposure band.  For the band with the lowest exposure, the highest exposure 
concentration in that band is typically taken as representative. For the highest exposure band, the 
geometric  mean  (GM)  of  the  concentrations  in  that  band  is  taken  as  representative.  For  the 
intervening bands, the arithmetic mean (AM) of each band is taken as representative. 

143 

 
 
4.2.3.  OEL/BLV policy options 

The different policy options are described in section 5.2 of this impact assessment.  

4.2.4.  Compliance with an OEL 

The procedures for determining  compliance with  an OEL differs among  Member States and may 
even be different within a Member State.  

The methodology for defining compliance with an OEL is described in section 3.2.5 of this annex. 

4.2.5.  Number of enterprises in each exposure band  

One  of  the  key  inputs  is  the  number  of  enterprises  in  each  exposure  band,  split  by  sector  and 
enterprise size (small, medium, large).  

The model assumes that companies  are distributed over the different  exposure bands in the same 
manner as workers, i.e. for example where 10% of exposure measurements are over a certain level, 
10% companies have exposure over that level. 

4.2.6.  Estimated  average  number  of  exposed  workers  and  workstations  using  the 

substance per company 

The  average  number  of  exposed  workers  and  workstations  was  estimated  for  small,  medium  and 
large companies in each sector.   

4.2.7.  Discount rates 

Based upon the discount rates used in other Member States, equal discounting of costs and benefits 
and a static discount rate was assumed as the most appropriate approach, and a static discount rate 
of 3% over the 40-year period was retained. 

4.2.8.  Current RMMs 

The following types of RMM are considered: 

•  Local Exhaust Ventilation (LEV), extraction at source; 
•  Worker  Enclosures  (WE),  i.e.  physical  separation  of  workers  in  an  enclosure  or  control 

room; 

•  Respiratory Protective Equipment (RPE); 
•  General Dilution Ventilation (GDV); 
•  Organisational & Hygiene measures (OH). 

Companies  are  expected  to  continue  using  RPE  to  keep  exposure  levels  below  the  OEL.  The 
assumption is that companies initially continue to use the existing and gradually (where possible) 
replace  the  RPE  with  other  measures  in  accordance  with  the  general  requirements  of  the  CMRD 
and to bring the concentration in the workplace in compliance with the OEL. As the replacement is 
done gradually (e.g. when new equipment is introduced) the costs of implementing other RMMs is 
assumed to balance the saved costs of using the RPE. Over a 40-year period, the use of RPE is not 
necessarily cheaper than implementing other RMMs so this assumption is not unjustified.  

144 

 
For each type of RMM, several levels that companies can achieve have been defined. These levels 
are summarised below. 

4.2.9.  RMM effectiveness 

Every RMM has a different level of effectiveness in reducing workers’ exposure to the substance in 
question.  The percentage reduction in exposure due to each type of RMM used in the analysis is 
shown below. 

Table 54 - percentage reduction in exposure achieved with RMMs and used in the cost model 

Type of RMM 
Substitution possible 
Substitution not possible 
RWK Rework  
LEV3 Full enclosure 
LEV2 Partial enclosure 
LEV1 Open hood 
LEV0 No LEV 
WE2 Pressurised or sealed 
WE1 Simple enclosed cab 
WE0 No enclosure 
RPE3 Breathing apparatus 
RPE2 Half or full-face negative pressure respirator or similar 
RPE1 FFP mask/ simple mask or similar 
RPE0 No mask 
OH1 Organisational measures 
OH0 No organisational measures 
GDV1 General dilution ventilation 
GDV0 No general ventilation 
Source: RPA (2024) 

% reduction 
100% 
0% 
50% 
100% 
90% 
80% 
0% 
100% 
80% 
0% 
100% 
95% 
60% 
0% 
30% 
0% 
30% 
0% 

In  cases  where  the  required  reduction  in  exposure  cannot  be  achieved  using  a  single  RMM,  the 
model allows for the possibility that organisational and hygiene measures (OH1) or rework (RWK) 
are combined with any other RMM to increase their effectiveness. 

Where the required reduction in exposure cannot be achieved using the RMMs in the table above or 
combining  them  with  OH1  or  RWK,  it  is  expected  that  the  company  in  question  would  have  to 
substitute the substance, or where this is not possible, the company would have to discontinue the 
operations that involve exposure to the relevant substance.   

4.2.10. RMM costs and lifespan 

Costs  of  RMMs  depend on  the  size  of  the  operations  of  the  relevant  company.  RMM  costs  have 
thus been estimated by company size band.  

RMM 

One-off costs 

Recurrent costs 

Lifespan 

Table 55 - RMM unit costs  

145 

 
 
LEV 3: Full 
enclosure 

Based on IOM210 – 
high end of costs 

LEV 2: Partial 
enclosure 

LEV 1: Open hood 
or add-on 

WE 2: Pressurised 
or sealed cabin 

Estimated reported in 
literature which range 
from €60,000 to 
€120,000 per 
company 
Estimates reported in 
published literature 
which range from 
€1,700 to €15,500 
Assumed the same as 
LEV 2 

10% based on one-off costs as 
recommended by US-OSHA (most 
likely electricity, maintenance & 
repairs) 

US-OSHA is no longer available, and 
no further studies giving an indication 
of the cost of recurrent costs have been 
found.  It is considered that the value 
of 10% is a reasonable assumption. 
10% based on US-OSHA 
(most likely electricity, maintenance & 
repairs, compensation air, heating) 

10% based on US-OSHA 
(most likely electricity, maintenance & 
repairs, compensation air, heating) 

Assumed the same as LEV2 

WE 1  : Simple 
enclosure 

Assumed the same as 
LEV1 

Significantly lower than LEV 1, 
assumed 3% 

RPE 3: Breathing 
apparatus 

RPE 2: Half or full 
face negative 
pressure 
respirator/ Mask 
with HEPA filters 
or similar 

Frontline Safety 
(undated) cost of a 
belt and a mask: 
€1,300 

Assume cylinder is 
then rented 
Hakimian et al.211: 
€25 

Assumed a new mask 
has to be purchased 
every two months due 
to wear and 
tear/accidental 
damage, etc.  
Cost per worker €150 

Boconline (undated): €50 for one hour 
of work (cylinder rental & refill) 

If used every working day for 1 hour, 
1,000% of one-off costs 

Hakimian et al.: €9 for a pair of HEPA 
filters 

Usage time 30 hours (Ok, et al. 2008) 

Annual cost per worker €75, i.e. 50% 
of one-off costs 

Mask: 1 
month, 
Filter: 30 
hours 

RPE 1: FFP mask/  Hakimian et al.: €1 

Not relevant but one-off costs incurred 

210 IOM (2011): SHEcan Report P937/4, Health socio-economic and environmental aspects of the possible amendments 
to the EU Directive on the protection of workers from the risks related to exposure to carcinogens and mutagens at 
work  
211 Hakimian, A. et al., 2015. Economic analysis of CNT lithium-ion battery manufacturing. Environmental Science: 
Nano, Issue 5, pp. 463-476. 

146 

Assumed 
the same as 
LEV2 
Assumed 
the same as 
LEV1 
Assumed 2 
years 

 
 
 
 
 
 
 
 
 
 
 
 
 
simple mask or 
similar 

per disposable mask 

every year 

OH1: 
Organisational & 
hygienic measures 

GDV1: General 
dilution ventilation 

Assumed a new mask 
is required every 
workday, resulting in 
an annual cost of 
€260/worker 
Some data provided 
through consultation 
for Cd (International 
Cadmium 
Association, ICdA) as 
part of CMRD 3, also 
consistent with IOM 

A large range of 
measures with 
different costs 

Assumed €1,000 per 
worker 
Hakimian et al.: €22 
per cfm (cubic feet 
per minute) required 
(Ok, et al. 2008): €10 
per cfm 

Some data provided through 
consultation for Cd (ICdA) for CMRD 
3 

Only 
incurred 
once 

Ok, et al212.: Training annual instructor 
cost €540 

A large range of measures with 
different costs 

Assumed 50% 

Hakimian (2015): Approx. 30% of 
one-off costs 

20 years 

(Ok, et al. 2008): 30% but this is for 
24hr operation 

Figure used: €20 per 
cfm 

Figure used: 30% 

Assumed 10 Air 
Changes Per Hour 

Assumed cfm 
required: Small: 300 
cfm, Medium: 2,000 
cfm, Large: 5,000 cfm 

Source: RPA (2024) 

Where unit costs were only available for one or two company size bands, these were extrapolated to 
other size bands based on the numbers of exposed workers and work stations in the different size 
bands. 

212 Ok et al (2008). Risk Analysis Modeling of Production Costs and Occupational Health Exposure of Single-Wall 
Carbon Nanotube Manufacturing. Journal of Industrial Ecology, 12(3), pp. 411-434. 

147 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The  costs  of  implementing  each  of  the  RMMs  in  a  specific  company  depend  on  the  number  of 
exposed workers or workstations using the relevant substance.   

Table 56 – costs of various RMMs in €  

LEV 3: Full 
enclosure 
LEV2: Partial 
enclosure 
LEV1: Open 
hood 
WE 2: 
Pressurised or 
sealed 
WE 1: Simple 
enclosed cab  
RPE 3: 
Breathing 
apparatus 
RPE2: Half or 
full face 
negative 
pressure 
respirator 
RPE 1: FFP 
mask/ simple 
mask 

Size of 
company 

Small 
2 workers exposed 
Exposed workers on 1 
machine 
Lifesp
an 
years 

Recur
rent 
(% of 
one-
off) 

Type of RMM  One-
off 
2021 

RWK: Rework  25,000 

45,000 

20 

10% 

30,000 

20 

10% 

7,000 

20 

10% 

30,000 

20 

10% 

Medium 
27 workers exposed 
14 machines 

Large 
75 workers 
40 machines 

One-
off 
2021 

Lifesp
an 
years 

350,00
0 
440,00
0 
240,00
0 
90,000 

240,00
0 

20 

20 

20 

20 

Recur
rent 
(% of 
one-
off) 

10% 

10% 

10% 

10% 

Recur
rent 
(% of 
one-
off)) 

10% 

10% 

10% 

10% 

One-
off 
2021 

Lifesp
an 
years 

20 

20 

20 

20 

1,000,
000 
1,700,
000 
650,00
0 
260,00
0 
650,00
0 

260,00
0 

7,000 

20 

3% 

90,000 

20 

3% 

20 

3% 

2,000 

2 

500%  27,000 

2 

500%  75,000 

2 

500% 

400  Mask: 

17% 

5,400  Mask: 

17% 

15,000  Mask: 

17% 

2 
month
s 

Not 
releva
nt, 1 
per 
day 

2 per 
day 

Not 
releva
nt 

27 per 
day 

2 
month
s 

Not 
releva
nt, 1 
per 
day 

Not 
releva
nt 

75 per 
day 

2 
month
s 

Not 
releva
nt, 1 
per 
day 

Not 
releva
nt 

50% 

20 

30% 

4,000 

6,000 

OH 1: 
Organisational 
measures 
GDV 1: 
General 
dilution 
ventilation 
Source: RPA (2024) 

50% 

54,000 

50% 

20 

30% 

40,000 

20 

30% 

150,00
0 

100,00
0 

148 

 
 
 
 
 
 
 
 
 
 
 
4.2.11. Suitability of RMMs for each sector  

Operational characteristics of the activities in each sector mean that not every RMM is suitable to 
control exposure in each sector.  The model thus considers the suitability of each RMM in each of 
the relevant industry sectors.  

The  amount  of  exposure  is  split into  work  where  the  worker  is  exposed  to  the  substance  for  less 
than an hour a day and for more than an hour a day.  This also equates to exposure for more or less 
than  2.5  days/month.    Many  production  activities  only  occasionally  use  the  relevant  substances.  
Where the exposure is less than an hour a day, it is acceptable, and often more cost effective, to use 
personal protective equipment (PPE) such as masks with filters or breathing apparatus.  

The form  of substance to  which workers are  exposed varies  considerably  from  dust and fibres to 
vapour,  fumes,  gas,  mist  and  aerosol.    Again,  the  form  of  substance  has  a  direct  bearing  on  the 
types  of  RMM  that  are  suitable.    For  example,  general  dilution  ventilation  is  not  advised  for 
removing dust as it tends to stir it up and spread it around.  For this analysis, the substance form is 
split into two types: dust, which also includes fibres; and gas, which includes all the other types.  

The extent of the spread is the final characteristic that affects the choice of RMM and this is split 
into  three  types:  local,  diffuse  and  peripheral.    Local  means  the  dust  or  gas  is  created  around  a 
specific  machine  and  often  means  that  highly  targeted  ventilation  can  effectively  remove  the 
chemical.  Other processes spread the substance over a wider area and this is known as diffuse. In 
this  case,  dilution  ventilation,  workers  enclosures  or  full  enclosures  are  more  suitable,  the  choice 
depending  upon  the  decrease  in  exposure  required.    Peripheral  means  that  the  substance  spreads 
more widely and causes exposure to workers beyond the area where the substance is being worked.  
This means that administrators, managers and sales staff may be exposed. 

Table 57 - Suitability of various RMMs to duration of exposure, form of the substance and extent of spread 

Type of RMM 

<1h 
Y 
Substitution 
Y 
Rework 
Y 
Full enclosure 
Y 
Partial enclosure 
Y 
Open hood 
Y 
No LEV 
N 
Pressurised or sealed 
N 
Simple enclosed cab 
Y 
No enclosure 
Y 
Breathing apparatus 
Neg. pressure respirator  Y 
Y 
FFP mask 
Y 
No mask 
Y 
Organisational 
measures 
No organisational 
measures 
General dilution 
ventilation 
No general ventilation 
Source: RPA (2024) 

Y 

Y 

N 

>1h 

Dust 

Gas 

Local 

Y 
Y 
Y 
Y 
Y 
Y 
N 
N 
Y 
Y 
Y 
Y 
Y 
Y 

Y 

N 

Y 

Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
N 
N 
N 
Y 
Y 

Y 

Y 

Y 

Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
N 

Y 

Y 

Y 

Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 

Y 

N 

Y 

149 

Diffuse  Peripheral 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 
Y 

Y 

Y 

Y 

Y 

Y 

Y 

 
 
4.3.  Calculation of the RMMs required for each policy option 

Source: RPA (2024) 

4.4.  Other key issues 

4.4.1.  Discontinuations in the cost model 

The cost model considers every scenario of sector, current exposure concentration, target exposure 
concentration and evaluates for the current RMMs, which available RMMs can achieve the target 
exposure concentration.  Only these RMMs can be selected for the scenario.  The potential RMMs 
include  the  option  of  substitution  and  also  the  worst-case  option  of  discontinuation.    The  model 
selects the RMMs with the lowest cost and calculates the cost of this scenario by multiplying it by 
the number of companies (the cost differs for each size of company, enabling the cost for each size 
of  company  to  be  found).    This  means  that  the  model  knows  how  many  companies,  by  size,  are 
allocated the RMMs for each scenario. 

The  cost  of  discontinuation  is  invariably  the  RMM  with  the  highest  cost,  therefore  if  this  is 
selected, it means  that no other RMMs  in  the cost  model are sufficiently effective to  achieve the 
reduction in exposure levels required to comply with an OEL/BLV policy option.   

150 

 
 
 
 
 
The  model  assumes  that  small  and  medium  enterprises  discontinuing  the  operations  that  involve 
exposure to the relevant substance would result in the entire company going out of business.  The 
logic behind this is that small and medium sized organisations are more likely to experience closure 
if their sole or main operation becomes unfeasible.  In contrast, large companies are more likely to 
discontinue divisions, lines or specific operations which would not result in the full closure of the 
business but the discontinuation of the line/process using the relevant substance.  The assumption is 
that 10% of a large company would close. 

The discontinuation cost is taken as the loss of profit213 taken over 20 years and the average profit 
is assumed to be 10% of turnover.  Historically, the two sectors that are most strongly represented 
in the substance specific reports are Manufacturing (operating profit margin 10%) and Construction 
(operating profit margin 11%).  A value of 10% is therefore taken as a typical profit margin in the 
modelling carried out for this study.   

The  average  turnover  of  small,  medium  and  large  companies  is  estimated  taking  the  Eurostat 
activity  categories  (which,  however,  sometimes  only  partly  correspond  to  the  relevant  sectors 
where exposure occurs), stakeholder consultation and internet searches into account.  

5.  THE COST MODEL FOR ESTIMATING BENEFITS AND COSTS FOR INTRODUCING WELDING 

FUMES IN ANNEX I OF THE CMRD 

The  methodology  for  calculating  the  benefits  and  costs  of  policy  option 2  (Annex  I)  for  welding 
fume are different to those used for limit values, because there are no data available about welding 
fume exposure levels. 

Since  policy  option  2  is  about  legal  clarity  (and  therefore  increased  awareness  of  the  risks  and 
better supply and use of RMMs), estimates relate to the costs and benefits of additional companies 
applying already required RMMs  

5.1.  Benefits 

The benefits model used for calculating the value of benefits due to reductions in ill-health due to 
lower limit values was adapted for use with welding fume.  The key differences are: 

•  Use of a single excess risk for all welders, taking into consideration all exposure levels, and 
all  levels  of  exposure.  This  was  done  because  there  is  no  exposure  data  available  for 
welding fume and no Exposure Risk Relationship (ERR) can be derived;  

•  This  excess  risk  is  subject  to  an  average  trend  of  reducing  by  1%  per  year,  and  this  was 
assumed  to  continue  for  the  next  40  years  for  the  baseline.    This  trend  was  based  upon 
various studies in the past and the view of the study team: it was validated by interviews and 
conversations with key stakeholders where they were specifically asking their opinion of the 
future trend for excess risk; and 

•  The impact of the policy option 2 (Annex I) is assumed to be a further 1% reduction for the 
first five years after the policy option takes effect, in other words, a 2% reduction for five 
years, returning to a 1% reduction from year six. 

213  In  RAC/SEAC  2017,  on  page  30,  SEAC  states  that  the  “welfare  impacts  should  be  measured  in  terms  of  the 
expected profit losses as those correspond to the loss in producer surplus.”   

151 

 
 
5.2.  Costs 

The  costs  model  used  to  calculate  the  cost  of  risk  management  measures  for  companies  due  to 
changes in limit values could not be used as it relies on detailed information about exposure levels 
which are not available. 

Two completely different approaches were devised; The approaches are: 

•  Bottom  up  –  this  is  based  upon  the  number  of  welders  that  are  estimated  to  move  from 
having  poor  or  no  risk  management  measures  (RMMs)  to  adequate  RMMs  as  a  result  of 
policy option 2 (Annex I) and multiplying this by the estimated additional average cost of 
these  RMMs.  In  addition,  only  a  proportion  of  the  workers  that  are  estimated  to  move  to 
better RMMs will need to buy new RMMS; some will simply turn on, or wear, the RMMs 
that they already have, which will not incur additional costs. This proportion is assumed to 
be 50% and together it enables a cost for these additional RMMs to be estimated.    

•  Top down - based upon the current market value of RMMs being used annually, an estimate 
of an assumed 1% increase in the sale of RMMs as a result of policy option two (Annex I) 
can be calculated.  

5.3.  Assumptions 

There is little data available to build estimates of costs and benefits. Several assumptions had to be 
made for the purpose of calculating costs and benefits, often with little basis. To attempt to validate 
these  estimates,  six  interviews  with  key  stakeholders  were  held  to  present  the  assumptions, 
calculations and estimates and asking their opinions about them (three EU level and three Member 
State  level  stakeholders  on  condition  of  anonymity).  Generally,  the  consensus  was  that  the 
estimates were a reasonable guess.  In a few cases, one or more stakeholders felt that an assumption 
was too high or too low. 

6.  ESTIMATION OF THE COSTS OF MONITORING, BIOMONITORING, HEALTH SURVEILLANCE AND 

ADMINISTRATIVE BURDEN 

The costs of monitoring air concentrations (sampling and analysis) and the costs of biomonitoring 
and  associated  health  surveillance  are  estimated  separately  to  the  core  cost  model.  The  cost  of 
monitoring does not include the administrative burden or internal cost to the company of managing 
the monitoring or biomonitoring and health surveillance campaigns, which is often performed by an 
external contractor.    

6.1.  Air monitoring costs  

To  what  extent  demonstration  of  compliance  with  an  OEL  involves  actual  measurements  in  the 
workplaces differs by Member States and sizes of the enterprises and consequently the estimate of 
total monitoring costs for air concentrations is subject to high uncertainty. 

6.1.1.  Number of samples per monitoring campaign 

It is assumed that the strategy for sampling is in accordance with the European Standards EN689. 
According to the experts consulted, it is common for medium and large sized companies to follow 
EN  689  whereas  for  small  companies  less  demanding  strategies  are  often  applied,  for  example, 
taking only one or a few indicative measurements.  

152 

 
The  strategy  described  in  the  European  Standards  EN689  gives  a  procedure  for  the  employer  to 
overcome  the  problem  of  variability  and  to  use  a  relatively  small  number  of  measurements  to 
demonstrate  with  a  high  degree  of  confidence  that  workers  are  unlikely  to  be  exposed  to 
concentrations exceeding the OELs. 

The  European  Standards  EN689  comprises  three  main  steps  concerning  groups  of  workers  in  a 
similar  exposure  group  (SEG):  these  are  groups  of  workers  undertaking  the  same  tasks.  The 
compliance with an OEL is determined by either a screening or a test of compliance. 

The screening test requires three to five exposure measurements on workers belonging to a SEG.  

• 

If all results are below: 

• 
• 

• 

1.  OEL for a set of three exposure measurements or,  
2.  0.15 * OEL for a set of four exposure measurements or,  
3.  0.2 * OEL for a set of five exposure measurements  
then it is considered that the OEL is respected: Compliance. 
If one of the results is greater than the OEL, it is considered that the OEL is not respected: 
Non-compliance.  If  the  first  measurement  result  is  above  the  OEL,  it  is  not  necessary  to 
perform any additional measurements.  
If all the results are below the OEL and a result above 0.1 * OEL (set of three results) or 
0.15  *  OEL  (set  of  four  results)  or  0.2  *  OEL  (set  of  five  results)  it  is  not  possible  to 
conclude  on  compliance  with  the  OEL.  No-decision.  In  this  situation  additional  exposure 
measurements  shall  be  carried  out  to  apply  the  test  based  on  the  calculation  of  the 
confidence interval of the probability of exceeding the OEL, as specified below.  

By the Test of compliance with the OEL, the appraiser shall select a statistical test of whether the 
exposures of the similar exposure group (SEG) comply with the OEL. The test shall measure, with 
at least 70% confidence, whether less than 5% of exposures in the SEG exceed the OEL.  

6.1.2.  Assumed number of measurements  

The number of measurements is not dependent on the number of potentially exposed workers, but 
the number of similar exposure groups (SEGs). A SEG may undertake more than one of the tasks 
defined by the Worker Contributing Scenarios (WCSs) in the Chemical Safety Reports (CSRs), and 
in  general,  it  is  assumed  that  the  number  of  SEGs  is  smaller  than  the  number  of  WCSs.  It  is 
furthermore assumed that the number of SEGs is higher in larger companies than in medium and 
small  companies  even  within  the same sector,  as the WCS may be divided on more SEGs in the 
larger companies.    

The  assumed  number  of  SEGs  and  number  of  exposure  measurements  for  compliance  testing  is 
shown in the table below. 

Table 58 - assumed number of SEGs and number of exposure measurements per campaign for compliance 
testing* 

Average number of SEGs per 
company 
OEL / median ≥ 2 ** 
Number of measurements per 
SEG,  
Total number of measurements 

Small 
1 

Medium 
4 

Large 
6 

3 

12 

3 

18 

3 

3 

153 

 
 
 
 
 
OEL / median < 2 ** 
Number of measurements per 
SEG,  
Total number of measurements 
Source: RPA (2024) 

5 

5 

5 

20 

5 

30 

* Each "exposure measurement" may consists of more samples if more than one parameter is measured. 

** Median of sector’s exposure concentrations  

6.1.3.  Frequency and percentage of companies undertaking monitoring  

A  significant  number  of  the  companies  are  expected  to  measure  exposure  concentration  to  refine 
their  risk  assessment  and  possibly  to  demonstrate  compliance  with  the  new  OEL.  The  costs  are 
based on the following overall considerations:  

•  Additional monitoring would not be needed in Member States where the OEL is already at 

the level of the policy option or lower.  

•  Larger companies in general undertake more often monitoring than smaller companies.  
•  The percentage of companies which would need to monitor increases as the OEL decreases 

(the larger the difference between the new OEL and current exposure concentrations). 

•  Not all companies would need additional monitoring  - some companies  already undertake 
monitoring  and some companies, in  particular smaller companies, would install additional 
RMMs without monitoring.  

It  is  assumed  that  those  companies  that  monitor  would  need  either  one  or  two  monitoring 
campaigns:  

•  For all companies that monitor at all, one monitoring campaign before the new RMMs are 

introduced to establish which RMMs are required; and  

•  For some of the companies, one further monitoring campaign after the introduction of the 
RMMs to demonstrate compliance if there is uncertainty as to whether the new RMMs will 
achieve compliance.  

It is  assumed that the first  campaign takes  place  at  the introduction of the OEL (first year of the 
assessment  period)  and  the  second  campaign  takes  place  three  years  later  and  the  costs  are 
discounted by the general rate used for the assessment.  

It is, furthermore, assumed that companies in Member States with an OEL at or below the level of a 
policy option would not need any additional monitoring to demonstrate compliance with the OEL 
of the policy option. 

For the companies in Member States with no OEL (for all relevant parameters) or an OEL above a 
policy option, the following monitoring is assumed in companies: 

•  At the lowest OEL level, all large and medium-sized companies will undertake a monitoring 
campaign  to  determine  which  RMMs  would  be  needed  to  comply  with  the  new  OEL.  In 
some companies with recent monitoring data and a good overview of the current exposure 
levels,  at  the  higher  OEL  levels,  existing  data  may  be  used  for  determining  the  need  for 
further  RMMs.  These  companies  would  only  need  a  campaign  after  installing  additional 
RMMs. 

154 

 
 
 
 
 
•  For  small  companies,  it  is  assumed  that  an  increasing  percentage  would  undertake  a 
campaign at lower OELs and at the highest OEL level only 20% would actually measure the 
concentration.  The  remainder  would  implement  further  RMMs  without  measuring 
concentrations but based on results of the existing risk assessments and general guidelines. 
It  is  assumed  that  even  a  smaller  percentage  would  undertake  more  than  one  campaign 
because  the  costs  of  monitoring  would  be  significant  in  comparison  with  the  costs  of  just 
implementing further RMMs. 

The  percentage  of  companies  assumed  to  require  additional  monitoring  in  those  Member  States 
with no OEL or an OEL above the policy option in shown in the table below. 

Table 59 - percentage of companies undertaking additional monitoring in those MS with no OEL or an OEL 
above the policy option 

Policy option 

Percentage of companies undertaking additional monitoring 

Before installing additional RMM, 
% of all companies 
Medium 
100% 

Large 
100% 

Small 
25% 

After installing additional RMMs, % 
of companies installing RMMs 
Large 
Medium 
Small 
100% 
90% 
25% 

15% 

10% 

10% 

90% 

70% 

60% 

90% 

70% 

60% 

15% 

10% 

10% 

70% 

50% 

30% 

80% 

60% 

40% 

Lowest OEL 
level 
Intermediate 
level 2 
Intermediate 
level 1 
Highest OEL 
level 
Source: RPA (2024) 

6.1.4.  Assumed costs of planning, sampling, reporting 

The number of samples, man-hours and costs of planning, execution and reporting for a campaign 
where an 8-h TWA for either the inhalable or respirable fraction is measured is shown in the table 
below. For campaigns where both respirable and inhalable fraction for the 8-h TWA is measured it 
is assumed that the number of samples is twice the number indicated here. However, this may vary 
with  substance.  In  addition,  the  cost  of  an  inhalable  and  respirable  sample  may  not  be  the  same.  
The  cost  per  sample  is  higher  for  measurements  below  a  certain  LOQ,  so  the  monitoring  cost  is 
higher for the lowest policy options.   

Table 60 - assumptions for time and costs for planning, sampling and reporting  

Number 

Unit 

Planning (independent of number of workplaces)  6 
9 
Sampling basic costs per day incl. first 
workplace 
Time per workplaces in addition to first 
workplace the same day 
Number of workplaces one person can sample a 
day 
Reporting independent of number of workplaces  5 
Additional reporting per workplace 

5 

1 

0.25 

man-hours/company 
man-hours/company 

man-hours/workplace 

workplaces/day 

man-hours/company 
man-hours/workplace 

155 

 
 
 
Rent of pump first day 
Rent of pump subsequent days 
Average daily rate of worker at all levels 
Average hourly rate of worker at all levels 
8-h TWA, respirable or inhalable, LOQ1 
(higher) 
8-h TWA, respirable or inhalable, LOQ2 (lower)  260 
Source: RPA (2024) 

80 
40 
500 
67 
230 

EUR/workplace 
EUR/workplace 
EUR/day 
EUR/hour 
EUR/sample 

EUR/sample 

The average rate for this kind of service for the EU as a whole is set at €67/hour. The starting point 
has  been  typical  Danish  rates  for  this  kind  of  OHS  services  of  €120/h  and  data  on  wages  and 
salaries for professionals in the EU Member States showing that the EU27 average was at 69% of 
the  Danish  salary  rates.  For  the  OELs4  study,  the  estimated  rates  used  in  the  UK  using  this 
approach was quite similar to the actual rates used.  

The  actual  wages  would  vary  by  Member  State  but  for  simplicity,  in  accordance  with  the 
methodology used for previous OEL studies, EU averages has been applied. The total costs at EU 
level  will  not  be  influenced  by  this,  but  it  results  in  some  uncertainly  as  to  the  distribution  by 
Member State and sectors.  

6.1.5.  Assumed costs of planning, sampling, reporting 

Below are the estimated costs per company of both monitoring campaigns.  Each substance report 
uses  these  values  to  calculate  the  cost  of  monitoring  based  on  all  the  companies  that  need  to  do 
monitoring, given the existing OELs in their Member State, size, and sector (higher or lower level 
of monitoring). 

Table 61 - costs of planning, execution, reporting and analysis of monitoring exclusive per company by size 
of company 

Activity 
Unit cost 

Unit 
cost 

OEL / median > 2 

OEL / median < 2 

S 

3 

M 

L 

12 

18 

S 

5 

M 

L 

20 

30 

Campaign 1 (Year 1) 
Workstations (number of 
samples) 
Total manhours 
Sampling days 
Planning, man-hours 
Execution, man-hours 
Reporting, man-hours 
Rent of equipment, first 
day 
Rent of equipment, 
subsequent days 
Costs excl. analysis 
Analysis, LOQ 1 
Analysis, LOQ 2 
Total costs, LOQ 1 

23 
1.0 
€402 
€737 
€385 
€80 

66 
50 
4.0 
3.0 
€402 
€402 
€2,412  €3,350 
€637 
€536 
€80 
€80 

25 
1.0 
€402 
€871 
€419 
€80 

97 
68 
6.0 
4.0 
€402 
€402 
€3,484  €5,226 
€838 
€670 
€80 
€80 

€67 
€67 
€67 
€80 

€40 

€0 

€80 

€120 

€0 

€120 

€200 

€230 
€260 

€1,604  €3,510  €4,589  €1,772  €4,756  €6,746 
€690 
€2,760  €4,140  €1,150  €4,600  €6,900 
€3,120  €4,680  €1,300  €5,200  €7,800 
€780 
€2,294  €6,270  €8,729  €2,922  €9,356  €13,646 

156 

 
 
 
 
 
 
 
Total costs, LOQ 2 
Campaign 2 (Year 3) discounted costs 
Total costs, LOQ 1 
Total costs, LOQ 2 
Source: RPA (2024) 

€2,384  €6,630  €9,269  €3,072  €9,956  €14,546 

€2,100  €5,738  €7,988  €2,674  €8,562  €12,488 
€2,182  €6,067  €8,482  €2,811  €9,111  €13,311 

6.2.  Biomonitoring and health surveillance costs 

6.2.1.  Assumed number of measurements  

Unlike  air  monitoring,  where  a  sample  of  measurements  is  taken,  all  exposed  workers  within  a 
facility  that  requires  health  surveillance  have  to  be  monitored.    Therefore,  the  number  of 
biomonitoring  and  health  surveillance  tests  carried  out  equals  the  number  of  exposed  workers  in 
situations where health surveillance is required.  If a biomonitoring test is required, the study team 
assumes that effectively full health surveillance also has to take place, as the worker will need to 
provide  the  sample  and  will  require  a  follow  up  meeting  with  a  medical  doctor  to  receive  the 
results. 

6.2.2.  Frequency of biomonitoring and health surveillance campaigns 

Some companies are expected to conduct health surveillance already to refine their risk assessment 
or  to  comply  with  national  BLVs.  The  model  is  developed  under  the  following  overall 
considerations:  

•  Additional monitoring would not be needed in Member States where the BLV is already at 
the  level  of  the  policy  option  or  lower,  provided  that  the  company’s  BLVs  and  OELs  are 
less than a given percentage of the BLV and OEL set down in Annexes IIIa and III of the 
CMRD. This percentage is set at 50%. 

•  The  percentage  of  exposed  workers  which  would  need  biomonitoring  and  health 
surveillance increases as the BLV decreases (the larger the difference between the new BLV 
and current BLVs in the Member State). 

It is assumed that those companies that monitor would need either one, two or three biomonitoring 
and health surveillance campaigns:  

•  For all companies that monitor at all, one monitoring campaign before the new RMMs are 

introduced to establish which RMMs are required.  

•  For some of the companies, one further monitoring campaign after the introduction of the 
RMMs to demonstrate compliance if there is uncertainty as to whether the new RMMs will 
achieve compliance.  

•  Campaign  1:  Year  1,  biomonitoring  only  of  all  exposed  workers  except  those  in  Member 

States with a BLV below the target BLV. 

•  Campaign 2: Years 2 to 6, annual biomonitoring and health surveillance by the proportion 
of exposed workers in each sector whose exposure will take them above a given percentage 
of the new BLV, which is set for each substance. 

•  Campaign 3: Years 7 to 40, annual biomonitoring and health surveillance for a proportion of 
companies  multiplied  by  the  number  of  exposed  workers  in  campaign  2,  which  is  set  for 
each  sector  by  the  study  team.  The  default  value  for  this  factor  for  most  sectors  is  set  at 
10%.  However, the study team believes that some sectors will never be able to achieve the 

157 

 
 
 
 
 
lowest policy options for BLVs and will always have to do health surveillance, whereupon 
this factor is set to 100%.   

6.2.3.  Assumed costs of planning, sampling and reporting 

The  number  of  samples,  man-hours  and  costs  of  planning,  execution  and  reporting  for  a 
biomonitoring and health surveillance campaign is shown in the table below. The cost per sample 
went  up  for  measurements  below  a  certain  LOQ,  so  the  monitoring  cost  can  be  higher  for  the 
lowest policy options. 

Two  estimates  or  costs  for  the  analysis  of  a  3-hydroxybenzo-a-pyrene  sample,  not  including 
transport costs were obtained.  One from a laboratory not yet analysing 3-hydroxybenzo-a-pyrene, 
which estimated €125/sample.  One from a laboratory that does analyse 3-hydroxybenzo-a-pyrene, 
which said €150-170/sample, depending on circumstances.  These were from German laboratories, 
which are probably more expensive than in some Member States.  The average cost of analysing a 
sample from two French laboratories was €60-65 per sample.  Prices for analysis usually fall if they 
become  more  popular,  so  there  is  reason  to  think  that  these  might  also  fall  as  measuring  3-
hydroxybenzo-a-pyrene is not common at present.  Based on this information, the cost of a standard 
analysis is taken as €100/sample, and a sample requiring a lower LOQ is taken as €200/sample.  

Analysing  samples  of  1,4-dioxane  is  likely  to  be  similar  in  cost  to  as  analysing  samples  of  3-
hydroxybenzo-a-pyrene,  therefore  the  costs  for  standard  and  lower  LOQs  are  also  taken  as 
€100/sample and €200/sample respectively. 

Table 62 - assumptions for time and costs for planning, sampling and reporting a biomonitoring and health 
surveillance campaign 

Number 

Unit 

0.25 

Biomonitoring manpower (Campaign 1) 
Medical doctor's time to see worker 
man-hours 
Biomonitoring and health surveillance manpower (Campaigns 2 and 3) 
man-hours 
Worker's time, before, test and after 
man-hours 
Manager's admin time 
Medical doctor's time to see worker 
man-hours 
Biomonitoring analysis 
Biomonitoring, LOQ1 (higher) 
Biomonitoring, LOQ2 (lower) 
Source: RPA (2024) 

1 
0.25 
0.5 

100 
200 

EUR/sample 
EUR/sample 

The average rate for this kind of service for EU as a whole is set at €67/hour equating to €500/day.  
The  actual  wages  would  vary  by  Member  State  but  for  simplicity,  in  accordance  with  the 
methodology used for previous OEL studies, EU averages has been applied. The total costs at EU 
level  will  not  be  influenced  by  this,  but  it  results  in  some  uncertainly  as  to  the  distribution  by 
Member State and sectors.  

6.2.4.  Estimated  costs  per  exposed  worker  of  three  biomonitoring  and  health 

surveillance campaigns 

158 

 
  
 
 
Below are the estimated costs per exposed worker of both monitoring campaigns.  Each substance 
report uses these values to calculate the cost of monitoring based on all the companies that need to 
do  monitoring,  given  the  existing  OELs  in  their  Member  State,  size,  and  sector  (higher  or  lower 
level of monitoring). 

Table 63 - costs of planning, execution, reporting and analysis of monitoring exclusive per exposed worker 
(Euro PV discounted over relevant number of years) 

Campaign 1 
Campaign 2 
Campaign 3 
Source: RPA (2024) 

LOQ1 
184 
995 
3,778 

LOQ2 
284 
1,537 
5,517 

6.3.  Administrative burden for companies 

For  enterprises,  the  cost  of  planning,  executing,  and  reporting  the  sampling  and  analysis  of 
monitoring is part of adjustment costs and is most often done by a  specialist company. However, 
someone in the enterprise has to work out what is required and the management of monitoring by 
the third party and this administrative task is included in the company administrative burden. The 
number of days required to manage a campaign discounted over 40 years is shown below. 

6.3.1.  Air monitoring administration burden 

The administrative burden costs for air monitoring per company by size are shown below, together 
with the days assumed to be required by companies by size to set up the monitoring each year.  As 
in the previous calculations of cost of the monitoring, the cost of a worker or manager is assumed to 
be €500/day. 

Table 64 - costs of companies’ administrative burden to manage first and second air monitoring campaigns, 
by size of enterprise 

Days to administrate monitoring one campaign 

Campaign 1 costs  

Campaign 2 costs (discounted) 

Source: RPA (2024) 

Small 
1 

€500 

€458 

Medium 
3 

€1,500 

€1,373 

Large 
6 

€3,000 

€2,745 

6.3.2.  Biomonitoring and health surveillance administration burden 

The administrative burden costs for biomonitoring and health surveillance per company by size are 
shown  below,  together  with  the  days  assumed  to  be  required  by  companies  by  size  to  set  up  the 
biomonitoring  and  health  surveillance  each  year.  As  in  the  previous  calculations  of  cost  of  the 
biomonitoring and health surveillance, the cost of a worker or manager is assumed to be €500/day. 

Table 65 - costs of companies’ administrative burden to manage three campaigns for biomonitoring and 
health surveillance, by size of enterprise 

Small 

Medium 

Large 

159 

 
 
 
 
 
 
Days to administrate monitoring one campaign 

1 

Campaign 1 (year 1) 

Campaign 2, (year 2-6 discounted) 

Campaign 3, (year 7-40 discounted) 

Source: RPA (2024) 

€500 

€2,290 

€9,114 

3 

€1,500 

€6,870 

6 

€3,000 

€13,739 

€27,343 

€54,686 

6.4.  Transposition costs for Member State Authorities  

Member  States  incur  costs  for  the  transposition  of  relevant  changes  into  national  legislation.  The 
exact  costs  depend  on  the  specific  changes  agreed  in  EU  legislation,  and  the  level  of  national 
autonomy  in  the  transposition  (which  influences  e.g.  the  number  of  departments  involved  in 
transposition  or  implementing  the  Directive).  Some  Member  State  may  further  require  regulatory 
impact assessments. Sweden is for example obliged to carry out an impact assessment on new EU 
legislation.  The  transposition  costs  are  therefore  likely  to  vary  significantly  between  Member 
States. 

Specific  data  on  the  costs  of  transposition  of  EU  legislation  by  specific  Member  States  are  not 
readily  available.  For  one  UK  impact  assessment  for  example,  “the  costs  of  amending  current 
regulations  to  implement  a  Directive  are  thought  to  be  around  £700,000”  (around  €950,000  in 
2021214).  Whereas  no  details  are  provided  for  that  calculation,  it  is  expected  that  these  costs 
correspond  to  a  substantial  legislative  change,  which  would  include  the  costs  of  making  (e.g. 
preparing  an  impact  assessment,  drafting  and  discussing  a  legislative  proposal),  printing  and 
publishing  the  legislation.  A  second  estimate  by  the  UK  Department  for  Transport215  provides  a 
substantially  lower  value,  stating  that  “a  combination  of  legal  and  technical  resources  as  well  as 
policy  advisors  are  usually  required  to  implement  such  a  change,  costing  approximately  £15,687 
per amendment” (approximately €20,000 in 2021). 

This impact assessment thus assumes €50,000 per Member State as an approximation of the general 
order of magnitude of the transposition costs in Member States that do not currently have an OEL, 
STEL or BLV. For those Member States that have an OEL, STEL or BLV, and need to change to a 
lower value is assumed to entail a lower cost of €30,000.  Member States that already have an OEL, 
STEL or BLV at or below each policy option do not incur a cost. 

This  impact  assessment  thus  assumes  €100,000  per  Member  State  as  an  approximation  of  the 
general  order  of  magnitude  of  the  transposition  costs  for  putting  welding  fume  into  Annex  I 
because this is likely to be accompanied by other changes to the CMRD to fix some contradictions 
caused by putting welding fume into Annex I, see section 5 of the welding fume substance report. 

214 RPA (2012) Ex-Post Evaluation and Impact Assessment Study on Enhancing the Implementation of the Internal 
Market Legislation Relating to Motor Vehicles.  
215 UK Department for Transport (2011), The potential cost and benefits to the United Kingdom of the measures 
outlined in the proposal for a Regulation of the European Parliament and of the Council on the approval and market 
surveillance of two or three wheel vehicles and quadricycles. Available at : 
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/2585/dft-2011-26-
ia.pdf  

160 

 
 
 
 
7.  APPROACH TO OTHER ISSUES 

7.1.  Assumptions and robustness of the estimates  

The overall methodology behind the impact assessment involves estimating the costs and benefits 
as accurately as possible.  The key data required for each element are: 

•  Benefits: 

o  Number of exposed workers by sector and size of company; 
o  Exposure distributions by sector;  
o  Exposure risk relationships (ERRs) and dose response relationships (DRRs) for each 

ill-health endpoints; and 

o  Discount rates. 

•  Costs: 

o  Number of companies with exposed workers by sector and size of company; 
o  Exposure distributions by sector; and 
o  Discount rates and many economic indicators. 

Occasionally, when the number of companies is low, all companies with exposed workers could be 
identified accurately. Nevertheless, the numbers of workers and companies by sector and size are 
usually  taken  from  Eurostat.  However,  the  companies  and  workers  actually  using  the  specific 
substance generally does not  include every company in  that sector, in  which case the appropriate 
proportion  has  to  be  estimated.  Furthermore,  only  a  proportion  of  workers  in  a  company  are 
exposed  to  the  specific  substance.  Generally,  the  consultation  survey  enables  an  estimate  of  the 
proportion of exposed workers to all workers on a site to be calculated and used for a sector, but 
usually there are some sectors that are not represented in the survey.  An estimate was then made, 
based on the substance, risk management measures expected to be in place, and the proportions in 
similar industries.  

The  ERRs  and  DRR  are  based  on  complex  toxicological  assessments  and  calculations,  which  in 
turn may be based on imperfect data such as animal and/or old data.  Wherever possible, an ERR 
and DRR is derived for all cancer and non-cancer endpoints that have an effect within the exposure 
concentrations likely to be found.  However, sometimes there are known endpoints, both cancer and 
non-cancer, where there  is  insufficient  or no evidence with  which to  derive an ERR or DRR and 
these endpoints have to be excluded from the analysis. 

Arguably the most difficult data of all to gather and analyse are the exposure data.  There are three 
main sources of this data: 

•  Consultation survey; 

•  Academic papers; and 

•  Confidential REACH chemical safety reports. 

There are often many issues with this data including: 

•  No indication as  to  whether personal  protective equipment  (PPE) or respiratory protective 
equipment (RPE) is used, and thus whether the measurement provided is what the worker 
was exposed to, or what they would have been exposed if they had not been using PPE or 
RPE; 

161 

 
•  There is no indication of the RMMs in place; 

•  The format of the data varies and could include any or all of statistics such as the arithmetic 

mean, median, various percentiles (25th, 75th, 90th, 95th), highest and lowest; 

•  Many records might indicate that they are below the limit of quantification (LoQ), but there 

is no indication of the value of the LoQ for this measurement; 

•  Often the data has to be converted, for example between inhalable and respirable fraction, 

and sometimes the conversion factors are contentious; and 

•  The data are old and the technology has substantially changed since it was gathered. 

All  the  available  information  was  gathered,  manually  evaluated,  interpreted  and  the  exposure 
distribution  for  each  sector  was  assembled,  and  then  the  models  was  run.  Both  the  exposure 
distributions and the costs and benefits were checked, adjusting the exposure distribution and other 
inputs, if necessary, until it is feels that both inputs and outputs are sensible.  

The discount rate has a huge effect on the estimates of costs and benefits. Finally, a wide range of 
other economic indicators are used in the cost model, but these are not discussed any further here.   

All of the assumptions are explained in detail in the specific substance reports216. 

In  each  of  the  substance  reports,  there  is  a  table  listing  the  limitations  and  uncertainties  for  the 
substance and indicating their potential impact on the conclusions.  Where there is an * this refers 
to  significant  over/underestimations.  The  absence  of  an  asterisk  indicates  lesser  impacts  of  the 
over/underestimations. The table below brings together all of the limitations that are considered to 
be significant. There are no significant impacts for isoprene. 

Table 66 – Overview of the key limitations/uncertainties for the substances 

Limitation or 
uncertainty 

Substance  Explanation 

Exposed 
workers  

Companies 
with exposed 
workers 

ERRs and 
DRRs 

Exposure 
distributions  

All 

All 

All 

All 

See text 

See text 

See text 

See text 

Discount rates  All 

See section 4.2.7 

216 RPA (2024), op. cit. 

162 

Likely U 
(underestimates) or 
O (overestimates) 

Costs 

Benefits 

U or O 

U or O 

U or O 

U or O 

U or O 

U or O 

U or O 

U or O 

U or O 

U or O 

 
 
Limitation or 
uncertainty 

Substance  Explanation 

Likely U 
(underestimates) or 
O (overestimates) 

Costs 

Benefits 

PAH 

Cost 
assessment – 
biomonitoring 
firefighters 

PAH 

PAH 

Additional 
health 
endpoints – 
skin cancer 

Additional 
health benefits 
from the 
introduction of 
a BLV 

Public authorities may not undertake biomonitoring and health 
surveillance for volunteer firefighters due to irregular (<1% of 
time) and low exposure. The cost is modelled based on 
professional and volunteer firefighters being subject to 
biomonitoring.  

O 

Skin cancer has also been definitively linked to PAH exposure 
but there are no quantifiable data on which to develop an 
impact assessment.  

The main routes for occupational exposure to PAH are 
inhalation and skin contact and both routes result in increased 
metabolite concentrations that can be monitored by the 
introduction of a BLV. However, it is not possible to quantify 
benefits because the presence of a substance in a biological 
matrix does not necessarily mean that it will result in adverse 
effects, while the absence does not necessarily indicate that an 
individual was not exposed. There is no ERR to link metabolite 
concentration to effects and the health benefits of introducing a 
BLV cannot be quantified.  

U 

U 

Contribution 
of dermal 
exposure to 
total uptake 

Cost 
assessment 
assumptions 

Exposed 
workforce 

Additional 
health 
endpoints 

1,4-
dioxane 

Welding 

There is limited evidence base to assess the contribution of 
dermal exposure to the total uptake. A significant dermal 
uptake would mean that both the costs and the benefits could 
be underestimated. 

U 

U 

Some key stakeholders thought that policy option two could 
result in a bigger investment in RMMs and reduction in worker 
exposure, but other key stakeholders thought that the policy 
would have no or negligible impact on worker protection. 

U or O 

U or O 

Welding 

Only full-time welders have been taken into account, not part-
time or occasional welders, or bystanders (non-welders) 

Welding 

Additional health endpoints were not included and cannot be 
included in the calculations as there are no data available. 

U 

- 

U 

U 

Response to 
policy option 
assumption 

Welding 

Some key stakeholders said that they thought there would be 
little further improvement in RMMs, whilst others felt the 
baseline was still low.  

U or O 

Future trends  Welding 

Increasing demand for welding due to Green Transition 
compounded by Russian invasion of Ukraine, requiring faster 
transition to renewables with associated investment in 
infrastructure requiring welding. 

U 

U 

RMMs in 
place 

Welding 

Baseline little understood.   

U or O 

Some of the exposure data used derives from outside the EU. This is usually included when there is 
either  no  or  poor  data  available,  or  when  detailed  and/or  recent  academic  research  contains  data 

163 

 
 
 
 
 
 
 
from outside the EU. The countries providing nearly all of the non-EU data are USA, UK, Japan 
and Australia. It is expected that the use of non-EU data increases the robustness of the estimates.   

7.2.  One-off costs and these costs versus annual turnover  

The first year costs include only the following costs: 

Initial costs in first year, (one-off and recurrent); and 

• 
•  Monitoring and associated administrative burden costs for campaign 1 in the first year. 

These first year costs are used in calculations where first year costs are calculated as a percentage 
of annual turnover and annual operating surplus. The discontinuation costs are not included in the 
first year costs. This is an issue because these costs are not only the costs of closing a facility, but 
also a proxy for costs incurred when a company can find RMMs that will enable it to company, but 
this  cannot  be  modelled,  and  it  is  likely  to  be  high  in  cost.  However,  these  figures  indicate  the 
financial  impact  upon  companies  that  are  not  expected  to  discontinue  or  experience  severe 
difficulty complying. 

Separate  calculations  are  made  to  evaluate  the  financial  burden  upon  the  whole  sector  over  time, 
and these costs do include discontinuation costs.  The total present value cost of compliance (risk 
management  measures,  monitoring  and  administrative  burden,  discounted  over  40  years)  is 
calculated as a percentage of both turnover and operating surplus discounted over 40 years. 

7.3.  Unemployment 

Under  the  proposed  OEL  options,  employment  conditions  and  workers  health  are  expected  to 
improve.  However,  employment  impacts  will  result  from  companies  forced  to  cease  operations 
involving the substance if they cannot comply with the limit values. 

There are many potential scenarios, some positive and some negative. Some of the positive effects 
will  still  have  a  cost,  such  as  retraining.  If  a  site  closes,  staff  at  all  levels  lose  their  jobs.  The 
scenarios include: 

In areas of low unemployment, some people will be re-employed quickly; 

• 
•  Some people find jobs relatively quickly, say within six months, but may need benefits or 

use insurance to cover their interim costs; 

•  Some people need retraining, with the cost of the training and their time whilst training to 

consider; 

•  Some people need to relocate, with associated relocation costs; 
•  Some people retire early incurring social benefits or the loss of tax income; 
•  Some people may be unemployed for a long time; 
•  Some  sites  may  have  a  much  bigger  impact  on  a  town,  particularly  if  it  is  the  major 

employer; 

•  Some  regions  have  a  concentration  of  certain  sectors,  and  several  closures  in  one  region 

could have a disproportionate impact; and 

•  The  closing  facility  might  be  taken  over  by  a  competitor  that  can  manage  or  afford  the 
compliance, although there will often be efficiency savings, which can often take the form 
of fewer middle managers.  This is likely to be restricted to specific sectors and/or regions. 

164 

 
If a sector and/or region is likely to have an overall impact that is much more positive or negative 
than average, this is indicated, and the calculations adjusted for the social cost of unemployment. 

The impacts associated with the potentially temporary loss of employment can be monetised based 
on  the  approach  set  out  in  ECHA217  and  adapted  from  Haveman  R,  H.    and  Weimer,  D.218,  and 
Duborg219.  The impacts include the following components: 

•  The value of output/wages lost during the period of unemployment; 
•  The costs of job search, hiring and firing employees; 
•  The “scarring effect”, i.e.  the impact of being made unemployed on future employment and 

earnings; and  

•  The value of leisure time during the period of unemployment. 

The study team has calculated the number of job losses based on the following: 

•  Number of companies discontinuing (by size of company (modelled)) x average number of 

employees per company (by size of company (Eurostat)). 

•  Modelling is based on discontinuations in small and medium sized companies resulting in 
full company closure. Discontinuations in large companies would result in partial closure or 
termination  of  the  production  line  where  exposures  occur;  this  is  taken  as  10%  of  large 
companies discontinuing. 

Social cost calculated220 as follows:   

•  Average  salary  (based  on  Eurostat  figures  per  sector)  x  job  losses  (per  sector,  by  size)  x 

ratio of social cost per job loss over annual pre-displacement wage. 

•  Ratio = 2.57 (EU27) - This ratio is calculated on the population in EU Member States and 
subsequently has been amended since previous OELs in which the ratio included the United 
Kingdom (a previous ratio of 2.72 for EU28). 

7.4.  Transitional periods 

Throughout  this  section,  the  final  OEL  is  called  the  “FOEL”  and  the  transitional  OEL  is  the 
“TOEL”.  In addition, the OEL under normal conditions without a transition is called the “OEL”. 

Normally Member States have two years to amend their legislation after the change to the CMRD, 
therefore, although the cost and benefits models work out costs and benefits from today, in reality, 
they will usually start from two years after the legislation is passed. However, as long as the costs 
and  benefits  are  calculated  using  the  same  time  periods,  the  cost  benefit  ratio  will  be  unchanged 
even if the actual costs and benefits would be reduced by the discount rates slightly. 

217 ECHA (2016) The social cost of unemployment. Available at: 
https://echa.europa.eu/documents/10162/13555/seac_unemployment_evaluation_en.pdf/af3a487e-65e5-49bb-84a3-
2c1bcbc35d25. 
218 Haveman R, H. and Weimer, D., L. (2015) ‘Public Policy Induced Changes in Employment’, Journal of Benefit-
Cost Analysis, 6, pp. 112–153. Available at: https://www.cambridge.org/core/journals/journal-of-benefit-cost-
analysis/article/public-policy-induced-changes-in-employment-valuation-issues-for-benefitcost-
analysis/98CA383367695FE9C92928D87DFE08D3#. 
219 Duborg, R. (2016) ‘Valuing the social costs of job losses in applications for authorisation’, The Economics Interface 
Limited. Available at: https://echa.europa.eu/documents/10162/13555/unemployment_report_en.pdf/e0e5b4c2-66e9-
4bb8-b125-29a460720554. 
220 Duborg, R. (2016), op. cit., table A7 

165 

 
 
The purpose of the transition period is to enable companies to comply in a controlled manner: 

•  Enabling them to implement major and expensive changes to RMMs; 

• 

• 

If possible, developing, finding and testing substitutes; and 

If  possible,  avoiding  discontinuations  and  avoiding  the  associated  disruption  of  supply 
chains.   

The  purpose  of  the  transition  period  is  not  to  reduce  costs:  these  companies  will  still  have  high 
costs.  There may be fewer discontinuations as a result of the transitional period –  this means that 
the  transitional  period  has  the  potential  to  reduce  the  overall  costs.  However,  even  if  the  actual 
costs  were  reduced  and/or  there  are  fewer  discontinuations  and  therefore  less  unemployment,  the 
change in these costs and/or unemployment is impossible to calculate. 

Therefore, the impact on the costs and benefits is only due to the discount factor. 

The same methodology  is used  for transitional costs and benefits  as for  calculations of costs  and 
benefits of OELs without transition, in particular:  

•  For the start of enforcement and the point when the one-off costs fall, this would mean: 

•  For the OEL and the TOEL, the enforcement date is at the end of year 2 and the costs and 

benefits start at the beginning of year 1. 

•  For the FOEL, the enforcement date is at the end of year 6 and the costs and benefits start at 

some point between years 1 and 5. 

•  Costs and benefits are calculated over a 40 year period.  

There are three categories of company regarding the TOEL and FOEL: 

•  Currently  operating  below  the  FOEL  –  these  companies  have  no  costs  and  no  benefits 

associated with them and are not considered further; 

•  Currently  operating  between  the  FOEL  and  the  TOEL  –  these  companies  should  find  it 
relatively  easy  to  comply.  Some  will  go  ahead  immediately  and  make  the  changes;  others 
will wait until the latest reasonable point (year 5), to implement the RMMs. Taking all these 
companies  together,  the  costs  and  benefits  are  assumed  to  start  at  the  midway  point  in  the 
transitional period, which is at the end of year 3. 

•  Currently operating above the TOEL – these companies may find it harder to comply.   

For some companies, complying with the TOEL will be nearly as difficult as complying with the 
FOEL, therefore, where possible, they will comply with the FOEL after two years: few companies 
want to make two sets of major changes only four years apart unless absolutely necessary.   

Some companies that have real difficulty complying with the FOEL may well not comply with the 
TOEL after two years.  This may lead to greater use of RPE to comply with the TOEL than normal.   

Taking all of these companies together, the costs and benefits are assumed to start at the midway 
point in the transitional period, which is at the end of year 3. 

If  we  assume  a  40  year  period  for  everything,  the  only  difference  in  the  transitional  costs  and 
benefits compared with the costs and benefits for OELs without a transitional period is a delay of 
three years, which equates to a reduction due to discount factors of 8.48%.  This is rounded to 8% 
to avoid spurious accuracy. 

It does not matter how the one off costs or operating costs fall, such as every year, every other year, 
or year 1 and 20 only, the factor is always 8%.  The change in the benefits due to a delay of three 
years is exactly the same, 8%. 

166 

 
All  costs and benefits  due to  monitoring, administration and health surveillance would  reduce by 
8%  too.    The  only  cost  that  would  not  alter  is  Member  State  transposition  costs  and  these  are 
insignificant in comparison.  As both the costs and benefits reduce by 8%, the cost benefit ratios are 
unchanged. 

The  costs  and  benefits  under  the  transitional  period  scenario  are  not  calculated  in  detail  for  the 
following reasons: 

•  The factor of 8% is broad, enveloping many assumptions: calculating every number minus 
8% is confusing, unnecessary, and indicates a level of accuracy that cannot be justified; 
•  All of the costs and benefits are based on many, sometimes considerable assumptions.  They 
are  best  viewed  as  an  order  of  magnitude  estimate.  A  movement  of  8%  is  relatively 
insignificant within the bigger picture. 

Therefore,  overall,  the  transitional  period  will  delay  impacts  by  an  average  of  three  years  and 
reduce  the  value  of  costs  and  benefits  by  approximately  8%  for  all  stakeholders,  employers, 
workers  and  public  administrations.    The  transitional  periods  for  cobalt  and  its  inorganic 
compounds and for PAH are thus expected to have an impacts on the following categories: 

•  EU competitiveness, research and development and SMEs; 
•  EU single market, the environment, and fundamental rights; 
•  Green Deal and the EU Strategic goals; 
•  Digitalisation; and 
•  EU strategic autonomy. 

167 

 
 
8.  MUTLI-CRITERIA ANALYSIS 

8.1.  Cobalt and inorganic cobalt compounds 

Table 67 – Multi-criteria analysis (all impacts over 40 years and additional to the baseline) by policy options for cobalt and its inorganic compounds, € million 

Impact 

Stakeholders 
affected 

PO 2 

PO 3 

PO 4 

PO 6 

PO 5 

Companies 

Companies 

Companies 

Companies 

Companies 

Companies 

Direct costs – adjustment and monitoring 
Risk management measures - 
first year  
Risk management measures -
recurrent 
Risk management measures -
discontinuations 
Risk management measures -
total 
Risk management measures -
total per company (in '000 €) 
Risk management measures 
excluding discontinuation costs 
-total per continuing company 
(in '000 €) 
Monitoring (sampling and 
analysis) 
Direct costs - administrative  
Company cost of administration 
burden 
Direct compliance costs – total 
Adjustment, monitoring and 
administration burden costs 
Adjustment, monitoring and 
administration burden costs per 
company (in '000 €) 
Direct costs - enforcement costs 
Transposition costs 
Indirect costs - other 

Companies 

Companies 

Companies 

Companies 

Public sector 

 € 1,481  

 € 2,171  

 € 5,991  

 € 9,643  

 € 629  

 € 256  

 € 708  

 € 427  

 € 698  

 € 1,833  

 € 119  

 € 80  

 € 112  

 € 80  

 € 13  

 € 9  

 € 9,768  

 € 1,922  

 € 637  

 € 125  

 € 237  

 € 111  

 € 231  

 € 579  

 € 38  

 € 24  

 € 51  

 € 7  

 € 636  

 € 41  

Cannot be  
monetised 
Cannot be  
monetised 
Cannot be  
monetised 
€ 530  

€ 35 

Cannot be  
monetised 

€ 47  

€ 6 

 € 582  

 € 38  

 € 88  

 € 21  

 € 20  

 € 129  

 € 8  

 € 8  

 € 39 

 € 4  

 € 172  

 € 12  

 € 0.91  

 € 0.91  

 € 0.91  

 € 0.91  

 € 0.91  

168 

 
Firms exiting the market - No. 
of company closures 
Firms discontinuing at least a 
part of their business - % 
Total compliance costs as % of 
turnover over 40 years 
(including discontinuations) 
First year compliance costs as 
% of turnover over 40 years 
(excluding discontinuations) 

Employment – Jobs lost 

Employment – Social cost 

International competitiveness 

Consumers 

Internal market  
Innovation 

Companies 

Companies 

Companies 

Companies 

Workers & 
families 
Workers &  
families 
Companies 

Consumers 

Companies 
Companies 

Public sector 

Specific MSs/regions - MSs 
that would have to change 
OELs 
Direct benefits – improved well-being - health 
Reduced cases of ill health – 
lung cancer 
Reduced cases of ill health – 
restrictive lung disease  
Reduced cases of ill health – 
upper airway irritation 
Ill health avoided, incl. 
intangible costs (M1 to M2) 
Direct benefits – improved well-being – safety 
Avoided costs 
Avoided costs 

Workers &  
families 
Workers &  
families 
Workers & 
families 
Workers &  
families 

Companies 
Public sector  

 1,086  

7.1% 

 142  

0.9% 

 57  

0.4% 

Up to 3% (small 
companies) 

Up to 1% (small 
companies) 

Up to 0.4% (small 
companies) 

Up to 29% (small 
companies), but up 
to 4% (medium 
companies) 
 25,849  

Up to 10% (small 
companies), but up 
to 1.5% (medium 
companies) 
 2,761  

 € 1,970  

 € 217  

Up to 5.8% (small 
companies), but up to 
0.75% (medium companies) 

 1,124  

 € 83  

No significant 
impacts 
No impact 

No  
significant impacts 
No impact 

Positive effects though not of significant importance. 
No or limited negative 
impact  
All 

Limited negative 
impact  
All 

No or limited 
negative impact  
All 

Cannot be  
quantified 
Cannot be  
quantified 
Cannot be  
quantified 

Cannot be  
quantified 

Cannot be  
quantified 
Cannot be  
monetised 
No  
significant impacts 
No impact 

 10  

0.1% 

Up to 0.2% (small 
companies) 

Up to 2.3% (small 
companies), but up 
to 0.3% (medium 
companies) 
 77  

 € 7  

No  
significant impacts 
No impact 

No or very limited 
impact 
All 

 51  

 4,365  

 12,266  

 23  

 2,842  

 7,363  

 23  

 2,842  

 7,363  

 12  

 1,000  

 2,135  

 € 146 - 135 
million  

 € 126 - 121 
million  

 € 75 - 74 million  

 € 69 - 68 million  

 € 29 - 27 million  

 € 2  
 € 8  

 € 2  
 € 7  

 € 1  
 € 4  

 € 1  
 € 4  

 € 0  
 € 1  

169 

Negative impacts 

Negative impacts 
in some sectors 

 Negative impact  

All 

 71  

 4,365  

 14,152  

 
 
Direct benefits – improved well-being - environmental 
Environmental releases 

All 

Direct benefits – market efficiency 
Level playing field 

Companies 

Indirect benefits 
Administrative simplification 

Companies 

Avoided cost of setting OEL221   Public sector 
Other impacts 
Recycling – loss of business 

Limited reduction of environmental release of cobalt. Changes to cobalt free alternatives will have positive impact 
whereas increased costs of some articles may have a negative. Increased costs of recycling may have a negative 
impact. 

A harmonised OEL at EU level would help to ensure a level playing field between companies operating in different 
EU Member States. 

Should all Member States have a harmonised OEL this would reduce the administrative burden for companies with 
operations across multiple Member States. 
 € 0.5  

 € 0.5  

 € 0.5  

 € 0.5  

 € 0.5  

Recycling companies  Negative impacts 
due to compliance 
costs.  

Negative impacts 
due to compliance 
costs.  

Minor negative impacts. 

Minor negative 
impacts. 

Minor negative 
impacts. 

Impacts on fundamental rights 

All 

Impacts on EU Green Deal 

All 

Impacts on digitalisation 
Contributions to the UN 
sustainable development goals 

Companies 
All 

Compulsory monitoring of cobalt levels will help to ensure that the fundamental right of workers to workplace 
environments which respect human health is reliably enforced. 
PO 2 is expected to result in negative impacts on the EU Green Deal (including EU Strategic Autonomy), PO 3 would 
lead to limited negative impacts while POs 4, 5 and 6 should not entail negative impacts.  
No impacts on digitalisation are expected.  
In relation to the third sustainable development goal – “good health and wellbeing - improved worker and  
family health” – the above comment for impacts on fundamental rights also applies. 

Source: Study team. 
* For large companies it is only 10% of the company activities that are assumed to close down. The share of large companies in the number of discontinuations is less than 3%.  

221 This element of avoided cost might be an under estimation of the total avoided costs. It could be that some Member States with an existing OEL would want to revise it during 
the  assessment period to increase worker protection. It is however not certain how many Member States would do that. This possible underestimation  would be insignificant 
compared with the other benefits. 

170 

 
 
8.2.  PAHs 

Table 68 – Multi-criteria analysis (all impacts over 40 years and additional to the baseline) by policy options for PAHs, € million 

Impact 

Stakeholders affected 

PO 2 

Direct costs – adjustment 
Risk management measures - first 
year 
Risk management measures – 
recurrent 
Risk management measures - 
discontinuation  
Risk management measures total  
Risk management measures total per 
company 
Monitoring (sampling and analysis) 
Risk management measures - first 
year 
Risk management measures – 
recurrent 
Risk management measures - 
discontinuation  
Risk management measures total  
Risk management measures total per 
public authority 
Monitoring (sampling and analysis) 
Transposition costs 
Direct costs - administrative 
Monitoring administrative burden 
Monitoring administrative burden 
Direct costs – total compliance 
Adjustment, monitoring and 

Companies 

Companies 

Companies 

Companies 
Companies 

Companies 
Public sector 

Public sector 

Public sector 

Public sector 
Public sector 

Public sector 
Public sector 

Companies 
Public sector 

Companies 

€ 1,727 

€ 2,872 

€ 32,392 

€ 36,993 
€ 0.08 

€ 549 
€ 544 

€ 5,328 

€ 0 

€ 5,872 
€ 7.75 

€ 0.87 
 € 1.27  

€ 118 
€ 0.18 

€ 37,660 

171 

PO 3 

€ 220 

€ 196 

€ 2,248 

€ 2,666 
€ 0.01 

€ 292 
€ 16 

€ 47 

€ 0  

€ 63 
€ 0.08 

€ 0.39 
 € 1.24  

€ 66 
€ 0.09 

€ 3,024 

PO5 * 

PO 4 

Cannot be 
monetised 
Cannot be 
monetised 
Cannot be 
monetised 
€ 2,529 
€ 0.01 

€ 290 
€ 16 

€ 47 

€ 0 

€ 63 
€ 0.08 

€ 0.39 
 € 1.24  

€ 65 
€ 0.09 

€ 2,885 

€ 5 

-€ 1 

€ 0 

€ 3 
€ 0 

€ 181 
€ 0 

€ 0 

€ 0 

€ 0 
€ 0 

€ 0.24 
 € 1.24  

€ 41 
€ 0.05 

€ 226 

 
 
 
 
 
 
 
 
 
 
 
 
Companies 

administration burden costs (OEL 
only) 
Adjustment, monitoring and 
administration burden costs per 
company (OEL only) 
Adjustment, monitoring and 
administration burden costs (OEL 
only) 
Adjustment, monitoring and 
administration burden costs per 
public authority (OEL only) 
Total compliance costs (OEL only)   Companies 

Public sector 

Public sector 

Direct costs - enforcement costs 
Enforcement costs except 
transposition 
Indirect costs - other 
Firms discontinuing at least a part of 
their business - No. of company 
closures 
Firms discontinuing at least a part of 
their business - % 
Total compliance costs as % of 
turnover over 40 years (including 
discontinuations) 

Public authorities  

Public sector 

Companies 

Companies 

Companies 

€ 0.09 

€ 5,873 

€ 7.75 

€ 0.01 

€ 63 

€ 0.08 

€ 0.01 

€ 63 

€ 0.08 

€ 43,533 

€ 3,087 

€ 2,949 

€ 0.001 

€ 0.29 

€ 0 

€ 226 

Enforcement costs may arise as a result of ensuring compliance with new OELs however these costs are not 
estimated as they are specific to Member States individual inspection regime. 

3,462 

0.79% 

146 

0.03% 

Up to 6.3% (C19.1 
Coking plants – small & 
medium enterprises) 

Up to 2.9% (C19.1 
Coking plants – small & 
medium enterprises) 

First year compliance costs as % of 
annual turnover (excluding 
discontinuations) 

Companies 

Up to 19% (C16.1 wood 
preservation – small 
enterprises) 

Up to 3% (C24.45 other 
non-ferrous metallurgy – 
small enterprises) 

Employment – Jobs lost 

Workers & families 

47,758 

2,725 

Employment – Social cost 

Workers & families 

€ 4,028 

€ 226 

172 

The number is likely to be 
lower than 146 

The number is likely to be 
lower than 0.03% 
Cannot be estimated Up to 
2.9% (C19.1 Coking 
plants – small & medium 
enterprises) 
Cannot be 
estimated 

Cannot be estimated – 
may be a reduction jobs 
lost due to fewer 
discontinuations 
Cannot be estimated – 
may be a reduction jobs 

- 

- 

Up to 0.01% (several 
sectors and company 
sizes) 

0.7% (several sectors – 
small enterprises) 

- 

€ 0 

 
 
 
International competitiveness 

Companies 

Consumers 

Consumers 

Negative impacts 

Significantly negative 
impacts 
Costs for enterprises at 7 ng/m3 and 70 ng/m3 make up a 
significant proportion of turnover/GOS and costs are 
expected to be passed onto consumers through 
increased prices; including C20.13 carbon black 
manufacturers, C19.1 coking, C24.45 other metallurgy, 
C10.13 and C10.2 smokehouses, G45.2 automotive 
repair, N81.22 chimney sweeps, C16.1 wood 
preservation, E38.2 soil remediation, F42.11 road 
paving, and F42.12 welding of railroad tracks. The 
impact of PO3 would be more limited than under PO 2. 

lost due to fewer 
discontinuations 

Limited negative impacts  No significant impacts 

The transitionary period provided for by PO 5 will 
delay the increase in consumer prices, or allow for a 
gradual increase over 6 years. 

Costs at 700 ng/m3 are less substantial and may not 
result in as significant price increases for consumers. 

Internal market  
Lowest to highest OEL 
Specific MSs/regions - MSs that 
would have to change OELs 

Companies 

Public sector 

1 : 1 

1 : 1 

1 : 1 

1 : 10 

27 Member States:  AU, 
BE, BG, CY, CZ, DE, 
DK, EE, EL, ES, FI, FR, 
HR, HU, IE, IT, LT, LU, 
LV, MT, NL, PL, PT, RO, 
SE, SI, SK 

26 Member States:  AU, 
BE, BG, CY, CZ, DK, 
EE, EL, ES, FI, FR, HR, 
HU, IE, IT, LT, LU, LV, 
MT, NL, PL, PT, RO, SE, 
SI, SK 

26 Member States:  AU, 
BE, BG, CY, CZ, DK, 
EE, EL, ES, FI, FR, HR, 
HU, IE, IT, LT, LU, LV, 
MT, NL, PL, PT, RO, SE, 
SI, SK 

23 Member States:  AU, 
BE, CY, CZ, DK, EE, EL, 
ES, FI, FR, HR, HU, IE, 
IT, LT, LU, MT, PL, PT, 
RO, SE, SI, SK 

Workers & families 

Workers & families 

Direct benefits – improved well-being - health 
Reduced cases of ill health (lung 
cancer) 
Reduced cases of ill health 
(developmental toxicity) 
Reduced cases of ill health (male 
infertility) 
Ill health avoided, incl. intangible 
costs (M1 to M2) 
Direct benefits – improved well-
being - safety 
Avoided costs 
Avoided costs 
Direct benefits – improved well-being - environmental 

Companies 
Public sector  

Workers & families 

Workers & families 

35 

38 

3,157 

€ 97 - 16 

€ 0.13 
€ 3.87 

141 

38 

3,157 

€ 182 - 59 

€ 0.54 
€ 5.26 

173 

35 

38 

3,157 

€ 89 - 15 

€ 0.12 
€ 3.87 

2 

7 

608 

€ 15 - 1 

€ 0.01 
€ 0.69 

 
 
 
Environmental releases 

All 

Direct benefits – market efficiency 
Level playing field 

Companies 

Indirect benefits  
Administrative simplification 

Companies 

Increased reduction in PAH emissions at all levels. In some sectors environmental emissions are expected to 
reduce as OELs become more stringent. This is due to RMMs resulting in greater containment/abatement of 
emissions (e.g. through increased use of closed systems or novel cleaner processes as they become available). It is 
unclear whether the use of alternatives would produce different levels of emissions and the extent to which this 
may occur, although as outlined in this report alternatives are not viable for most sectors. In the example of road 
paving where alternatives may be available, it is unknown whether emissions would be affected. 

A harmonised OEL at EU level would help to ensure a level playing field between companies operating in 
different EU Member States.  As shown above (‘Specific MSs/regions - MS that would have to change OELS’), at 
all policy option levels the introduction of an EU wide OEL would result in greater alignment of Member States.  

Should all Member States have a harmonised OEL/BLV this would reduce the administrative burden for 
enterprises with operations across multiple Member States. However, the majority of enterprises under review are 
small and are unlikely to have multinational operations and be unaffected by this simplification. Sectors with the 
highest costs are typically medium and large enterprises which may benefit from such an administrative 
simplification. 

Avoided cost of setting an OEL 
Other impacts 
Recycling – loss of business 

Public sector 

€ 1.80 

€ 1.75 

€ 1.75 

€ 1.60 

Recycling companies  Metallurgical sectors may result in discontinuations at the lowest policy option levels, which in turn would result in 

less production of materials within the EU. However, it is anticipated that companies would continue to source 
materials from outside the EU to meet demand and subsequently materials available for recycling would be 
unaffected. 

Impacts on fundamental rights 

Impact on EU Green Deal 

All 

All 

Impacts on digitalisation 

Companies 

However, metallurgical sectors also undertake secondary production (recycling) of metals which would also be 
subject to costs related to OELs. At 7ng/m3 metallurgical sectors are expected to have significant discontinuations 
resulting in loss of EU capacity to recycle metals. At 70 ng/m3 the impacts to metallurgical sectors are less 
significant in terms of discontinuations, thereby assuming capacity to recycle metals is maintained. Recycling is 
not considered to be impacted in other areas. 
Positive impact on health and safety.  Increased monitoring will help to ensure that future exposures remain 
controlled and worker risk remains low. 
PO 2 is expected to result in negative impacts on the EU Green Deal (including EU Strategic Autonomy), PO 
would also lead negative impacts, although more limited thant under PO 2. PO 5, with its transitional period, is 
expected to have limited impacts on EU Green Deal. PO 4 is expected not to have any impacts.   
Digitalisation may be impacted by high costs to silicon metal and graphite manufacturers (used in semiconductor 
manufacturing, fuel cells, PV solar panels and EV batteries). Costs and discontinuations related to silicon (C24.45) 
are estimated to be significantly negative at 7 ng/m3, negative at 70ng/m3, and negligible at 700 ng/m3 suggesting 

174 

 
 
Contributions to the UN sustainable 
development goals 

All 

impacts on digitalisation would mainly be experienced at the most stringent policy option level. Regarding graphite 
production (C23.99b) modelling estimates significantly negative costs at 7 ng/m3 and negative costs at 70 ng/m3 
indicating cost impacts on digitalisation at these levels (no impacts at 700 ng/m3). Synthetic graphite production is 
reliant upon C19.1 coking which also experiences significant costs at the lowest two policy options. Collectively 
the difficulties of silicon and graphite production sector to meet costs at the two lowest policy options may result in 
negative impacts on digitalisation through increased material costs or greater reliance upon imports from third 
countries (primarily China). With its transitional value, PO 5 is expected to have more limited impacts on 
digitalisation than PO 3.  
Goal 3 – positive 
Goal 7 – positive  
Goal 8 – positive  
Goal 14 and 15 – positive 

Source: Study team. 
* Transitional period: 140 ng/m3 & 0.3 nmol/mol creatinine for six years and then 70 ng/m3 & 0.3 nmol/mol creatinine 

175 

 
 
8.3. 

1,4-dioxane 

Table 69 – Multi-criteria analysis (all impacts over 40 years and additional to the baseline) by policy 
options for 1,4-dioxane, € million 

Impact 

Stakeholders 
affected 

PO 2 

PO 3 

Companies 

Companies 

Companies 

Companies 

Companies 

Companies 

Companies 

Companies 

Companies 

Direct costs - adjustment 
Risk management measures 
- first year 
Risk management measures 
– recurrent 
Risk management measures 
- discontinuation  
Risk management measures 
total  
Risk management measures 
total per company 
Monitoring (sampling and 
analysis) 
Direct costs - administrative  
Administration burden 
Direct costs – total compliance 
Adjustment, monitoring and 
administration burden costs  
Adjustment, monitoring and 
administration burden costs 
per company 
Direct costs - enforcement costs 
Transposition costs 
Enforcement costs except 
transposition 

Public sector 
Public sector 

Indirect costs - other 
Firms discontinuing at least 
a part of their business - 
No. of company closures 
Firms discontinuing at least 
a part of their business - % 
Total compliance costs as 
% of turnover over 40 years 
(including discontinuations) 
First year compliance costs 
as % of annual turnover 
(excluding 
discontinuations) 
Employment – Jobs lost 

Companies 

Companies 

Companies 

Companies 

Workers & 
families 

€ 53 

-€ 34 

€ 102 

 € 121 

€ 0.067 

 € 2.35  

 € 0.74  

€ 125 

€ 0.07 

€ 0 

€ 0 

€ 0  

€ 0 

€ 0 

 € 0.55  

 € 0.21  

€0.76 

€ 0.0004 

 € 0.81  

 € 0.78  

Enforcement costs may arise as a result of ensuring 
compliance with new OELs however these costs 
are not estimated as they are specific to Member 
States individual inspection regime. 

6.3 

0.4% 

0.8% 

0 

0% 

0.01% 

Up to 14.3% (C20.1, 
C20.3 and C20.5 
chemicals - small 
enterprises) 
140  

Up to 0.06% (M72.1 
laboratories - small 
enterprises) 

0 

 € 0 

Employment – Social cost  Workers & 

 € 13 

International 
competitiveness 
Consumers 
Internal market  
Lowest to highest OEL 
Specific MSs/regions - MSs 
that would have to change 

families 
Companies 

Consumers 
Companies 

Some non-EU countries would have less stringent 
OELs 

No significant impact 
7.3 mg/m3-7.3 mg/m3 

No significant impact 
20 mg/m3-20 mg/m3 

Public sector 

27 

25 

176 

 
Workers & 
families 
Workers & 
families 
Workers & 
families 

OELs 
Direct benefits – improved well-being - health 
Reduced cases of ill health 
(kidney effects) 
Reduced cases of ill health 
(liver effects) 
Reduced cases of ill health 
(local irritation in the nasal 
cavity) 
Ill health avoided, incl. 
intangible costs (M1 to M2) 
Avoided costs 
Avoided costs 
Direct benefits – improved well-being - environmental 
Environmental releases 

Workers & 
families 
Companies 
Public sector  

All 

497 

633 

4,382 

 € 1.6 
 € 2 

 € 2 - 3 million  

0 

0 

0 

 € 0 - 0 million  

 € 0 
 € 0  

Potentially, a reduction in emissions into the air but 
unclear impact on emissions to water 

Direct benefits – market efficiency 
Level playing field 

Companies 

Indirect benefits  
Administrative 
simplification 

Companies 

Synergy 

Companies 

Public sector 

Avoided cost of setting 
OEL  
Other impacts 
Recycling – loss of 
business 
Impacts on fundamental 
rights 
Impacts on EU Green Deal  All 
Impacts on digitalisation 
Contributions to the UN 
sustainable development 
goals 

Recycling 
companies 
All 

Companies 
All 

The ratio between the maximum and minimum 
national OEL is currently 3.65. The ratio between 
the maximum/minimum STEL is 2.08. A reduction 
in the OEL and STEL is likely to improve the level 
playing field in the internal market. 

Should all Member States have a harmonised OEL 
this would reduce the administrative burden for 
enterprises with operations across multiple Member 
States. However, the majority of enterprises under 
review are small and are unlikely to have 
multinational operations and be unaffected by this 
simplification.  
Synergies in terms of exposure reduction for other 
chemical substances used in production sectors may 
occur.  The specific substances will vary between 
the sectors.  The level of synergy to be harnessed 
will also depend on the RMMs applied in each 
enterprise. 

€ 2.7 

€ 1.8 

No impacts expected 

Improved occupational health 

No impact expected.  
No impact expected. 
Potential for reduced emissions into the air but it is 
unclear whether this would not increase emissions 
into wastewater. 

Source: RPA (2024) 

8.4. 

Isoprene 

Table 70 – Multi-criteria analysis (all impacts over 40 years and additional to the baseline) by policy 
options for isoprene, € million 

177 

 
 
 
Impact 

Direct costs – adjustment 
Risk management measures – 
first year 
Risk management measures – 
recurrent 
Risk management measures - 
discontinuation 
Risk management measures – 
total 
Risk management measures – 
total per company 
Monitoring (sampling and 
analysis) 
Transposition costs 
Direct costs – administrative 
Company cost of administration 
burden 
Direct costs – total compliance 
Adjustment, monitoring and 
administration burden costs 
Adjustment, monitoring and 
administration burden costs per 
company 
Direct costs - enforcement costs 
Enforcement costs except 
transposition 

Stakeholders 
affected 

Companies 

Companies 

Companies 

Companies 

Companies 

Companies 

Public sector 

Companies 

Companies 

Companies 

Public sector 

Indirect costs – other 
Firms discontinuing at least a 
part of their business - No. of 
company closures 
Firms discontinuing at least a 
part of their business - % 
Total compliance costs as % of 
turnover over 40 years (including 
discontinuations) 
First year compliance costs as % 
of turnover over 40 years 
(excluding discontinuations) 
Employment – Jobs lost 
Employment – Social cost 
International competitiveness 
Consumers 
Internal market  
Lowest to highest OEL* 
Specific MSs/regions - MSs that 
would have to change OELs 

Companies 

Companies 

Companies 

Companies 

Workers & families 
Workers & families 
Companies 
Consumers 
Companies 

Public sector 

Companies 
Regulation 
Direct benefits – improved well-being - health 
Reduced cases of ill health – 
liver cancer 
Reduced cases of ill health – 
degeneration of olfactory 
epithelium  

Workers & families 

Workers & families 

8.5 mg/m3 

€ 0 

€ 0 

€ 0 

€ 0 

€ 0 

€ 0.19 

€ 1.22 

€ 0.11 

€ 0.30 

€ 0.004 

Enforcement costs may arise as a result of 
ensuring compliance with new OELs however 
these costs are not estimated as they are specific to 
Member States individual inspection regime. 

0 

0 

Up to 0.002% (Synthetic rubber manufacture – 
small companies) 

Same as above 

0 
€ 0 
No impact 
No impact 
1 : 1 

AU, BE, BG, CY, CZ, DK, EE, EL, ES, FI, FR, 
HR, HU, IE, IT, LU, LT, LV, MT, NL, PL, PT, 
RO, SE, SI, SK  
€ 0 

0 

0 

178 

 
Workers & families 

Reduced cases of ill health – 
degeneration of spinal cord white 
matter 
Ill health avoided, incl. 
intangible costs (M1 to M2) 
Direct benefits – improved well-being - safety 
Companies 
Avoided costs 
Avoided costs 
Public sector  
Direct benefits – improved well-being - environmental 
Environmental releases 

Workers & families 

All 

Direct benefits – market efficiency 
Level playing field 

Companies 

Indirect benefits 
Administrative simplification 

Companies 

0 

€ 0 

€ 0 
€ 0 

No direct or indirect impacts on the environment 
and environmental legislation will occur under any 
of the policy options. 

A harmonised OEL at EU level would help to 
ensure a level playing field between companies 
operating in different EU Member States. See row 
on ‘internal market’ for how harmonisation would 
occur at each policy option. 

Should all Member States have a harmonised OEL 
this would reduce the administrative burden for 
companies with operations across multiple 
Member States. This reduction in administrative 
burden however would be less likely to have 
significant impacts in the case of isoprene due to 
the estimation that all companies already have 
relatively consistent operating processes which 
would not be influenced by the implementation of 
any of the policy options. 

Avoided cost of setting OEL  
Other impacts 
Recycling – loss of business 

Public sector 

€ 2.40 million 

Recycling companies  No impacts are expected to be felt by recycling 

Impacts on fundamental rights 

All 

Impacts on EU Green Deal 
Impacts on digitalisation 
Contributions to the UN 
sustainable development goals 

All 
Companies 
All 

Source: RPA (2024)

companies as a result of any of the policy options. 
Compulsory monitoring of isoprene levels will 
help to ensure that the fundamental right of 
workers to workplace environments which respect 
human health is reliably enforced. 
No impacts on EU Green Deal 
No impacts on digitalisation are expected.  
In relation to the third sustainable development 
goal – “good health and wellbeing - improved 
worker and family health” – the above comment 
for impacts on fundamental rights also applies. 

179 

 
8.5.  Welding fumes 

Table 71 – Multi-criteria analysis (all impacts over 40 years and additional to the baseline) by policy 
options for welding fumes, € million 

Impact 

Stakeholders affected 

PO 1 

Direct costs – compliance 
Risk management measures and 
discontinuation costs (one-off 
and recurrent) 
Monitoring (sampling and 
analysis) 
Direct costs - administrative burdens 
Company cost of administration 
burden 
Direct costs – total 
Compliance, monitoring and 
administration burden costs per 
company 
Direct costs - enforcement costs 
Transposition costs 
Enforcement costs 
Monitoring costs  
Adjudication costs 
Indirect costs – other 
Firms exiting the market - No.  
of company closures 
Employment – Jobs lost 

Companies 

Companies 

Companies 

Companies 

Public sector 
Public sector 
Public sector 
Public sector 

Companies 

Workers & families 

Employment – Social cost 
International competitiveness 

Workers & families 
Companies 

Public sector 

Consumers 
Companies 

Consumers 
Internal market  
Lowest to highest OEL 
Specific MSs/regions - MSs that 
would have to change their 
policy or OELs 
Direct benefits – improved well-being – health 
Reduced cases of cancer  
Reduced fatalities  
Reduced non-fatalities 
Ill health avoided, incl.  
intangible costs (M1 to M2) 
Direct benefits – improved well-being – safety 
Companies 
Avoided costs 
Avoided costs 
Public sector  
Direct benefits – improved well-being – environmental 
Environmental releases 
Direct benefits – market efficiency 
Level playing field 

Workers & families 
Workers & families 
Workers & families 
Workers & families 

Companies 

All 

€ 67 - 156 

None expected 

N/A 

€ 67 – 156 

€ 2.7 
None 
None 
None 

None predicted 

Not quantified.  
No legal change, awareness raising. 
Not estimated 
International competition is low for welding as 
welding often needs to be done in situ on site 
and cannot be exported. 
None predicted. 
Not quantified. 

Less compliance in Eastern and Southern EU 
Member States according to anecdotal evidence 
heard by the study team. 

1,618 
1,079 
270 
M1: €997.5 
M2: €510 

€4.7 
€16.4 

Not quantified 

Awareness raising may lead to an improved 

180 

 
 
 
level playing field between and within Member 
States. 

Companies 
Public sector 

Not applicable 
Not applicable 

Indirect benefits  
Administrative simplification 
Avoided cost of setting OEL 
(EU27) 
Other impacts 
Recycling – loss of business 

Recycling companies 

Not applicable.  Circular economy principles in 
EU27 encourage recycling including recycling 
of metal products which will sometimes involve 
welding.  This is not predicted to be exported, 
due to the subsidiarity principle - waste 
management including recycling should be 
undertaken by local and regional authorities. 
Not applicable 
No impact 
Not applicable 
Positive minor impact towards UN SDG 3: 
good health and wellbeing and UN SDG 8: 
Decent work & economic growth  

Impacts on fundamental rights 
Impacts on EU Green Deal 
Impacts on digitalisation 
Contributions to the UN 
sustainable development goals 

All 
All 
Companies 
All 

Source: RPA (2024) 

181 

 
 
 
 
 
 
 
 
ANNEX 5: COMPETITIVENESS CHECK 

1.  OVERVIEW OF IMPACTS ON COMPETITIVENESS  

Dimensions of 
Competitiveness 

Impact of the initiative 
(++ / + / 0 / - / -- / n.a.) 

References to sub-sections of the 
main report or annexes 

Cost and price competitiveness 

“0” to “-” 

International competitiveness  

“0” to “-” 

Capacity to innovate 

“0” to “-” 

SME competitiveness 

“0” to “-” 

Sections 6.1.2 (b), 6.2.2 (b), 6.3.2 (b), 
6.4.2 (b) and 6.5.2 (b) 

Sections 6.1.2 (b), 6.2.2 (b), 6.3.2 (b), 
6.4.2 (b) and 6.5.2 (b) 

Sections 6.1.2 (b), 6.2.2 (b), 6.3.2 (b), 
6.4.2 (b) and 6.5.2 (b) 

Sections  6.1.2  (a),  6.2.2  (a),  6.3.2  (a), 
6.4.2 (a) and 6.5.2 (a) 

2.  SYNTHETIC ASSESSMENT  

In total, the costs to businesses (including SMEs) resulting from the package of preferred options 
represent  a  small  share  of  turnover  for  all  sectors  (below  0,6%),  with  the  exception  of  small  and 
medium-sized  enterprises  operating  in  coking  plants  and  coal  tar  distillation  sectors  where  they 
might represent between 2% and 3% of turnover over 40 years. If we take the situation in the short 
term,  businesses  operating  in  coking  plants,  manufacturers  of  refractory  products,  graphite  and 
carbon electrode manufacturers, steel and iron foundries, ferroalloys, other non-ferrous metallurgy 
companies,  and  coal  fired  power  plants.  would  need  to  make  investiments  in  additional  RMMs 
from  the  very  beginning  which  would  represent  more  than  10%  of  their  gross  operating  surplus. 
Except for graphite and electrode manufacturers, these sector are mainly composed of SMEs, which 
have less capacity to absorb additional costs. Therefore, consumers dependent on the above sectors 
are  likely  to  be  impacted  with  a  share  of  adjustment  costs  being  passed  on  to  them.  As  all  these 
sectors, except coal fired power plants, are subject to the transitional period, these companies would 
have  more  time  to  plan  their  investments.  Therefore,  the  impact  on  consumers  is  expected  to  be 
mitigated but not totally excluded.  

Furthermore,  the  structure  of  most  of  the  sectors  concerned  by  the  package  of  preferred  option 
should  remain  unchanged,  in  particular  with  the  introduction  of  some  transitional  measures  for 
PAHs and cobalt and its inorganic compouds. Despite the introduction of these measures, it cannot 
however  be  excluded  that  some  businesses  would  still  discontinue  in  some  sectors,  in  particular 
coking  industry.  However,  this  impact  is  expected  to  be  much  lower  than  the  same  limit  values 
without  any  transitional  periods  as  the  latter  corresponds  to  what  employers  within  the  ACSH 
judged  as  necessary.  Therefore,  the  presence  of  transitional  values  in  the  package  of  preferred 
option should limit the negative impact on consumers, without guarantee of completely excluding 
it in certain sectors. For that reason, the impact on consumers, both in terms of prices and diversity 
of supply, dependent on the above sectors is expected to be negative. For all other sectors, which 
represent  a  majority  of  those  sectors  impacted  by  this  initiative,  the  impact  is  likely  to  be 
negligigble or even null.  

 
 
 
The impact of the package of preferred options on the  capacity to innovate should be negligible 
for  most  sectors  as  the  total  costs  to  companies  represent  a  very  small  share  of  their  R&D 
expenditures. However, some impacts on innovation cannot be excluded for SMEs operating in the 
following sectors: coking plants (costs to businesses represent up to 160% of R&D expenditures), 
soil remediation (up to  155%), welding of railroad track (up to  120-135%) and other non-ferrous 
metallurgy.  

With regard to the impact of the package of preferred options on  international competitiveness, 
although the package of preferred options would lead to more stringent provisions to comply with 
for  companies  operating  in  the  EU  compared  to  those  active  in  non-EU  countries,  the  costs 
compared to turnover are overall very limited in most sectors. Therefore, the compliance costs are 
expected  to  not  exceed  the  costs  of  relocation  of  activities,  so  that  businesses  would  not  be 
encouraged  to  relocate  their  activities  outside  of  the  EU.  Furthermore,  most  of  businesses 
potentially  impacted  by  the  package  of  preferred  options  are  SMEs.  They  usually  operate  at 
national scale, or even on-site, which limits either the possibility to relocate or the competition from 
outside of the EU.  

Despite this, sectors such as steel and iron foundries, ferroalloys, aluminium manufacturers, other 
metallurgy,  casting  of  metal  and  graphite  and  carbon  electrode  manufacturers  already  experience 
pressure  from  cheaper  imports,  particularly  from  Asian  countries.  Additional  operational  costs 
arising  from  compliance  costs  could  negatively  impact  their  competitiveness  against  cheaper 
imports.  Nevertheless,  this  negative  impact  will be  mitigated  by  the  transitional  period  for  PAHs 
(and to a lesser extend for cobalt and its inorganic compounds) as businesses will have more time to 
plan  their  investments.  Nevertheless,  it  cannot  be  ruled  out  that  the  package  of  preferred  options 
will  have  an  impact  on  the  competitiveness  of  these  sectors.  Furthermore,  a  significant  share  of 
coking plants were expected to discontinue with the introduction of the final limit value for PAHs 
without transitional period. With the transitional measures provided by in the package of preferred 
option, the number of discontinuations is expected to be lower. However, it cannot be excluded that 
some coking plants would still discontinue, which would result in a greater dependence on imports 
from  non-EU  countries  for  those  companies  using  products  from  coking  plants,  such  as  in  the 
production  of  batteries  for  the  storage  of  energy  produced  by  wind  turbines,  semiconductors  and 
electric vehicles.  

Overall,  the  impact  on  international  competitiveness  should  be  negligible  for  most  sectors. 
However, some businesses operating in the sectors mentioned above might be negatively impacted 
by  the  package  of  preferred  option,  while  the  transitional  measures  provided  by  in  this  package 

183 

 
 
 
 
should limit this negative impact. Therefore these transitional options contribute to avoid imposing 
financial constraints in a way which would hold back the creation and development of SMEs222   

More  than  99%  of  businesses  with  exposed  workers  to  the  substances  subject  to  this  impact 
assessment  are  SMEs.  Overall,  the  share  of  compliance  costs  compared  to  turnover  or  gross 
operating product is higher for SMEs than large companies operating in the same sector. Therefore, 
they  are  likely  to  be  more  impacted  by  the  package  of  preferred  options  compared  to  larger 
enterprises.  Furthermore,  as  described  in  section  6,  SMEs  are  more  likely  to  experience  more 
discontinuations than larger companies (although the number of SMEs possibly impacted remains 
very limited compared to its total number. As an example, the number of SMEs for all substances 
expecting  to  discontinue  represent  –  up  to  0.04%  of  the  total  number  of  SMEs  with  exposed 
workers).  The  transitional  measures  provided  by  in  the  package  of  preferred  options  will  benefit 
more to SMEs than large companies as SMEs will have more time to plan their investments, which 
should  also  reduce  the  number  of  discontinuations  compared  to  the  same  package  of  options 
without  transitional  periods.  Therefore,  the  impact  on  the  competitiveness  of  SMEs  should  be 
limited.  

222 As requested by TFUE in its Article 153 (2) (b) 

184 

 
 
 
 
 
 
 
 
ANNEX 6: RELEVANT SECTORS, USES, EXPOSURE CONCENTRATIONS 
AND NATIONAL REGULATORY FRAMEWORKS 

1.  COBALT AND INORGANIC COBALT COMPOUNDS 

1.1.  Relevant sectors with exposed workers 

Table 72 - relevant sectors with risk of exposure to cobalt and inorganic cobalt compounds 

NACE description 

Uses / processes 

NACE 
code 
C10.91 

Short name for 
sector 

Manufacture, feeds 

C19.20 

C20.12 

C20.13-
20.14 

Petrochemical, 
catalyst 
Manufacture  of  dyes 
and pigments 
Manufacture  of  basic 
chemicals 

C20.30 

Manufacture  of  paints 
and inks 

C20.59 

Catalysts  

C20.59 

Formulation 

of 

refined 

Manufacture  of  prepared 
feeds for farm animals 
Manufacture 
petroleum products 
Manufacture  of  dyes  and 
pigments 
Manufacture 
other 
inorganic  basic  chemicals; 
other 
Manufacture 
organic basic chemicals 

of 

of 

of 
and 

paints, 
Manufacture 
varnishes 
similar 
coatings,  printing  ink  and 
mastics 
Manufacture 
chemical products n.e.c. 

other 

of 

Manufacture 
chemical products n.e.c. 

of 

other 

C21.20 

Pharmaceuticals 

C22.11 

Production of tyres  

of 

Manufacture 
pharmaceutical 
preparations 
Manufacture of rubber tyres 
and  tubes;  retreading  and 
rebuilding of rubber tyres 

185 

Manufacture  of  prepared  feeds  for 
farm animals 
Service life of catalysts in oil refining 

Manufacture of dyes and pigments 

Manufacture of other inorganic cobalt 
compounds  
Production  of  polyamide  powder  for 
cosmetics 
Manufacture of driers/paints 
Manufacture  of 
surface treatment 
Manufacture  of  cobalt  carboxylates 
and resinates (intermediate use) 
In-house  manufacture  of  organic 
cobalt driers 

formulations 

for 

Production  of  catalysts;  use  of  cobalt 
as  an  intermediate  in  the  manufacture 
of catalysts  
Manufacture  and  use  of  aqueous 
mixtures  for  local  metallization  of 
cobalt and cobalt alloys 
Formulation 
chemicals 
Formulation  of  products  for  biogas 
production  
Formulation 
biotechnology 
Manufacture 
preparations with cobalt 

of  water 

veterinary 

treatment 

products 

for 

of 

of 

In-house  manufacture  of  organic 
cobalt adhesion agents 

 
 
 
 
C23.1 

Glass  

C23.4 

Ceramics 

C23.7 

Cutting stone 

C24.10  

Steel 

C24.45 

Manufacture  of  cobalt 
and cobalt alloys 

of 

and 

other 
ceramic 

Manufacture  of  glass  and 
glass products 
Manufacture 
porcelain 
products 
Cutting, 
finishing of stone 
Manufacture  of  basic  iron 
and steel and of ferro-alloys 
Other  non-ferrous  metal 
production 

shaping 

and 

C25.5 

Powder metallurgy 

C25.61 

Surface  treatment  of 
metals 

Forging, pressing, stamping 
and  roll-forming  of  metal; 
powder metallurgy 
Treatment  and  coating  of 
metals 

C25.62 

Machining 

Machining 

C25.73 

Manufacture of tools  Manufacture of tools 

C25.99 

Manufacture  of  other 
metal 
fabricated 
products n.e.c. 

of 

Manufacture 
other 
fabricated  metal  products 
n.e.c. 

C26.1 

C26.51 

Production 
of 
electronic components 
and boards 
Humidity 
cards 

indicator 

C27.2 

Batteries 

Manufacture  of  electronic 
components and boards 

Manufacture of instruments 
for 
and 
appliances 
measuring, 
and 
navigation 
Manufacture  of  batteries 
and accumulators 

testing 

C28.11 

C29.10-30  Automotive 

Engines and turbines  Manufacture of engines and 
turbines,  except  aircraft, 
vehicle and cycle engines 
Manufacture 
of  motor 
vehicles,  trailers  and  semi-
trailers;  Manufacture  of 

Use  of  pigments  and  decolouriser  in 
glass 
Use of pigments in ceramics industry  

Service life of diamond tools 

Production of cobalt alloyed steels 

from 

Production of primary cobalt metal 
Recovery  of  slags,  matte,  slimes  and 
non-ferrous  metal 
sludges 
production  
Production of cobalt alloys powder 
Production  of  sintered  articles  not 
covered elsewhere 

(surface 

and  passivation 

Plating 
treatment) 
Thermal spraying  
Painting  metal  (non-metallic  surface 
treatment) 
Service  life  of  hardmetal  tools  and 
diamond tools 
Production  of  hardmetal  tools  and 
diamond tools 
Use  of  cobalt  metal 
manufacturing (3D-printing)  
Production of magnets 
Use  of  cobalt-containing  alloys  for 
sandblasting in industrial setting 
Industrial  use  of  cobalt-containing 
mixtures in brazing technique 
Production  of  varistors  and  other 
electronic components 
Production of printed circuit boards 
Production of humidity indicators 

in  additive 

Production of batteries 

Use of cobalt alloys (thermal spraying, 
welding, machining, etc.) 

and  passivation 

Plating 
treatment) 
Service life of hardmetal tools 

(surface 

186 

 
 
 
 
 
C30.30 

Air and spacecraft 

C32.50 

Medical  and  dental 
devices 

E38.32 

Metal recovery 

and 

other transport equipment 
Manufacture  of  air  and 
spacecraft 
related 
machinery 
Manufacture  of  medical 
and  dental  instruments  and 
supplies 
Recovery 
materials 

sorted 

of 

Cross-sectoral 
activities 
Cross-sectoral 
activities 

Biogas 

Welding 

Source: RPA (2024) 

Use of cobalt alloys (thermal spraying, 
welding, machining, etc.) 

Production  of  medical  and  dental 
implants and restorations 

secondary  cobalt 

Manufacture  of 
metal  
Recycling of hardmetal scrap 
Recycling of batteries 
Recycling of catalysts 
Recycling  of  electrical  and  electronic 
waste (WEEE) 
Nutrient in biogas production 

Welding  of  cobalt  alloys  (various 
sectors) 

1.2.  Estimated number of enterprises with exposed workers in the EU 

Table 73 – estimated number of EU enterprises with exposed workers by sector and by size of enterprise  

Sector 

Number of enterprises 

Small      
<50 
employees 

Medium    
50-249  
employees 

Large    
>249  
employees 

Total 

C10.91  Manufacture, feeds 
C19.20 
C20.12  Manufacture of dyes and 

Petrochemical, catalyst 

pigments 
Manufacture of basic chemicals 

C20.13-
20.14 
C20.30   Manufacture of paints and inks 
C20.59 
C20.59 

Catalysts  
Formulation of other chemical 
products 
Pharmaceuticals 
Production of tyres  
Glass  
Ceramics 
Cutting stone 
Steel 

C21.20 
C22.11 
C23.1  
C23.4 
C23.7 
C24.10  
C24.45  Manufacture of cobalt and 
cobalt alloys 
Powder metallurgy 

C25.5 

30 
41 
4 

11 

3 
7 
11 

0 
0 
15 
105 
20 
4 
0 

17 

6 
41 
11 

7 

1 
6 
11 

8.0 
3 
7.5 
45 
10 
1 
6 

3 

 300  
 82  
 15  

 30  

 10  
 13  
 35  

 8  
 3  
 50  
 500  
 1,000  
 7  
 6  

 30  

264 
0 
0 

12 

6 
0 
14 

0 
0 
28 
350 
970 
2 
0 

11 

187 

 
 
 
 
 
 
 
C26.1 

Surface treatment of metals 

C25.61 
C25.62   Machining 
C25.73  Manufacture of tools 
C25.99  Manufacture of other fabricated 
metal products n.e.c. 
Production of electronic 
components and boards 
Humidity indicator cards 
Batteries 
Engines and turbines 
Automotive, parts 
Air and spacecraft 

C26.51  
C27.2 
C28.11 
C29.30 
C30.30 
C32.50   Medical and dental devices 
Metal recovery 
E38.32 
Biogas 
Welding 
Total  
Source: RPA (2024) 

329 
 4,800  
 2,024  
113 

188 

3 
 -    

 105  
 108  
 113  
 300  

 -    

 2,697  
40 
 12,476  

94 
900 
230 
30 

50 

1 
 8  
 17  
 13  
 10  
 150  
 7  
 279  
8 
 2,063  

47 
300 
46 
8 

13 

1 
 8  
 8  
 9  
 7  
 50  
 8  
 124  
3 
 795  

 470  
 6,000  
 2,300  
 150  

 250  

 5  
 15  
 130  
 130  
 130  
 500  
 15  
 3,100  
 50  
 15,334  

1.3.  Estimated number of exposed workers in the EU 

Table 74 – estimated number of workers in the EU exposed to cobalt and inorganic cobalt compounds  

Sector 

C10.91 

C20.12 

C19.20 

Manufacture, 
feeds 
Petrochemical, 
catalyst 
Manufacture of 
dyes and pigments 
Manufacture of 
C20.13-
20.14 
basic chemicals 
C20.30   Manufacture of 
paints and inks 
Catalysts  
Formulation 
Pharmaceuticals 
Production of 
tyres 
Glass  
Ceramics 
Cutting stone 
Steel 

C23.1  
C23.4 
C23.7 
C24.10  

C20.59 
C20.59 
C21.20 
C22.11 

Number 
of exposed 
workers 

Number of 
companies 
with 
exposed 
workers 

Total 
number of 
workers in 
companies * 

 1,800  

 300  

 9,000  

Number 
exposed per 
company 

Percentage 
exposed in 
companies 

 6  

 7  

 88,200  

 10,500  

 153  

 10,100  

 1,100  

 4,600  
 8,100  
 5,100  
 5,900  

 8,600  
 55,300  
 20,900  
 700  

 97  

 20  

 70  
 49  
 119  
 100  

 18  
 15  
 3  
 14  

20% 

1% 

22% 

29% 

18% 

20% 
21% 
19% 
5% 

10% 
14% 
14% 
14% 

 600  

 2,300  

 2,900  

 200  

 910  
 1,700  
 950  
 300  

 900  
 7,500  
 3,000  
 100  

 82  

 15  

 30  

 10  

 13  
 35  
 8  
 3  

 50  
 500  
 1,000  
 7  

188 

 
 
 
 
 
 
 
 
C24.45 

C25.5 
C25.61 

Manufacture of 
cobalt and cobalt 
alloys 
Powder metallurgy 
Surface treatment 
of metals 

C25.62   Machining 
C25.73 

C25.99 

C26.1 

C26.51  

C27.2 
C28.11 

Manufacture of 
tools 
Manufacture of 
other fabricated 
metal products 
n.e.c. 
Production of 
electronic 
components 
Humidity indicator 
cards 
Batteries 
Engines and 
turbines 
Vehicles 

C29.10-
30 
Air and spacecraft 
C30.30 
C32.50   Medical and dental 
devices 
Metal recovery 
Biogas 
Welding 

E38.32 

Total  
Source: RPA (2024) 
*Rounded figures 

 660  

 6  

 2,200  

 110  

30% 

 900  
 5,200  

 25,000  
 30,000  

 30  
 470  

 3,800  
 44,000  

 6,000  
 2,300  

 83,300  
 114,400  

 1,120  

 150  

 6,400  

 30  
 11  

 4  
 13  

 7  

24% 
12% 

30% 
26% 

17% 

 3,000  

 250  

 20,700  

 12  

15% 

 100  

 1,950  
 2,200  

 5,200  

 2,200  
 5,000  

 1,100  
 5,400  
550 
113,000 

 5  

 1,200  

 15  
 130  

 6,900  
 7,300  

 130  

 17,300  

 130  
 500  

 15  
 3,100  
 50  
15,334 

 6,300  
 16,700  

 3,300  
 36,900  
 4,700  
872,300 

 20  

 130  
 17  

 40  

 17  
 10  

 73  
 2  
 11  
7  

8% 

28% 
30% 

30% 

35% 
30% 

33% 
15% 
12% 
13% 

1.4.  Exposure concentrations by sectors 

Table 75 - summary of exposure concentrations (in µg Co/m3, inhalable fraction) by sectors, with 
adjustment for the use of RPE.  

Sector 

AM 

P50 

P75 

P90 

P95 

P99 

C10.91  Manufacture, feeds 
C19.20 
C20.12  Manufacture  of  dyes 

Petrochemical, catalyst 

 0.3  
3.4 
6.5 

and 

pigments 
Manufacture of basic chemicals  2.4 

C20.13-
20.14 
C20.30   Manufacture of paints and inks 

 0.2  
2.2 
3.2 

1.1 

4.0 

1.25 

189 

 0.4  
4.1 
7.3 

2.5 

3.7 

 0.8  
7.3 
15.6 

5.6 

9.8 

 1.2  
10.3 
24.5 

9.0 

 2.7  
19.4 
57.0 

22.0 

17.6 

52.8 

 
 
 
 
 
 
 
C20.59  Catalysts and other chemicals 
Formulation other chemicals 
C20.59 
Pharmaceuticals 
C21.20 
Production of tyres  
C22.11 
Glass  
C23.1  
Ceramics 
C23.4 
Cutting stone 
C23.7 
C24.10   Steel 
C24.45  Manufacture  of  cobalt  and 

C26.1 

cobalt alloys 
Powder metallurgy 
Surface treatment of metals 

C25.5 
C25.61 
C25.62   Machining 
C25.73  Manufacture of tools 
C25.99  Manufacture of other fabricated 
metal products n.e.c. 
Production 
components 
C26.51   Humidity indicator cards 
C27.2 
C28.11 
C29.10-
30 
C30.30  Air and spacecraft 
C32.50   Medical and dental devices 
E38.32  Metal recovery 

Batteries 
Engines and turbines 
Automotive 

electronic 

of 

Biogas 
Welding, etc.  

Source: RPA (2024) 

0.3 
2.6 
0.3 
1.2 
3.0 
6.7 
2.5 
5.4 
5.3 

4.8 
3.2 
6.3 
4.8 
7.4 

7.6 

0.2 
1.3 
6.2 
3.2 

6.2 
11.5 
3.8 
0.0 
12.9 

0.1 
0.8 
0.0 
0.2 
1.5 
3.5 
0.9 
2.7 
2.6 

3.0 
1.7 
4.8 
3.0 
4.0 

4.2 

0.1 
0.4 
4.7 
1.7 

4.7 
7.8 
2.6 
0.0 
8.0 

0.2 
2.3 
0.1 
0.8 
3.3 
7.7 
2.5 
6.0 
5.9 

5.7 
3.7 
7.8 
5.7 
8.7 

9.0 

0.2 
1.2 
7.7 
3.6 

7.7 
14.5 
4.6 
0.0 
16.8 

0.6 
6.1 
0.5 
2.5 
6.8 
16.0 
5.9 
12.6 
12.5 

10.3 
7.3 
12.2 
10.3 
17.8 

1.0 
11.0 
1.0 
4.8 
10.5 
24.6 
10.0 
19.4 
19.4 

14.5 
11.1 
15.8 
14.5 
27.1 

2.8 
33.0 
3.7 
16.7 
23.4 
55.0 
26.6 
43.7 
44.5 

27.9 
23.9 
25.8 
27.9 
59.8 

17.9 

27.0 

58.3 

0.5 
3.0 
12.2 
7.2 

12.2 
25.2 
7.9 
0.0 
32.7 

0.7 
5.1 
15.9 
10.9 

15.9 
35.2 
11.0 
0.06 
48.7 

1.8 
14.2 
26.4 
23.6 

26.4 
65.7 
19.9 
0.13 
100.2 

Table 76 - summary of exposure concentrations (in µg Co/m3, inhalable fraction) by sectors, without 
adjustment for the use of RPE. 

Sector 

AM 

P50 

P75 

P90 

P95 

P99 

C10.91  Manufacture, feeds 
C19.20 
C20.12  Manufacture  of  dyes  and 

Petrochemical, catalyst 

 4.0  
 27.3  
 6.5  

 1.8  
 17.6  
 3.2  

 4.2  
 32.8  
 7.3  

 9.0  
 58.4  
 15.6  

 13.8  
 82.0  
 24.5  

 31.8  
 155.2  
 57.0  

C20.13-
20.14 
C20.30  

pigments 
Manufacture 
chemicals 
Manufacture  of  paints  and 
inks 

basic 

of 

C20.59  Catalysts 
chemicals 
Formulation other chemicals 

C20.59 

other 

and 

 19.5  

 8.4  

 20.0  

 44.8  

 72.0  

 176.0  

 31.7  

 10.0  

 29.6  

 78.4  

 140.8  

 422.4  

 2.1  

 0.4  

 1.6  

 4.8  

 8.0  

 22.4  

 21.0  

 6.0  

 18.4  

 48.8  

 88.0  

 263.6  

190 

 
 
 
 
 
 
 
 
 
Pharmaceuticals 
Production of tyres  
Glass  
Ceramics 
Cutting stone 

C21.20 
C22.11 
C23.1  
C23.4 
C23.7 
C24.10   Steel 
C24.45  Manufacture  of  cobalt  and 

of 

C26.1 

cobalt alloys 
Powder metallurgy 
Surface treatment of metals 

C25.5 
C25.61 
C25.62   Machining 
C25.73  Manufacture of tools 
C25.99  Manufacture 

electronic 

other 
fabricated  metal  products 
n.e.c. 
Production  of 
components 
C26.51   Humidity indicator cards 
C27.2 
C28.11 
C29.10-
30 
C30.30  Air and spacecraft 
C32.50   Medical and dental devices 
E38.32  Metal recovery 

Batteries 
Engines and turbines 
Automotive 

Biogas 
Welding, etc.  

Source: RPA (2024) 

 1.0  
 9.4  
 23.9  
 53.7  
 10.1  
 42.9  
 42.3  

 38.0  
 25.9  
 50.2  
 38.0  
 59.5  

 0.2  
 1.6  
 11.6  
 28.0  
 3.6  
 21.6  
 20.8  

 24.0  
 13.6  
 38.8  
 24.0  
 32.0  

 0.6  
 6.4  
 26.4  
 62.0  
 9.8  
 48.4  
 47.6  

 46.0  
 29.2  
 62.8  
 46.0  
 70.0  

 1.9  
 19.6  
 54.4  
 127.6  
 23.6  
 100.4  
 99.6  

 82.0  
 58.4  
 97.2  
 82.0  
 142.0  

 3.9  
 38.4  
 83.6  
 196.4  
 39.8  
 154.8  
 155.2  

 116.0  
 88.4  
 126.0  
 116.0  
 216.4  

 14.7  
 133.6  
 187.2  
 440.4  
 106.4  
 349.6  
 356.0  

 222.8  
 191.2  
 206.0  
 222.8  
 478.8  

 60.7  

 33.6  

 72.0  

 143.2  

 216.0  

 466.8  

 0.8  
 10.6  
 24.7  
 12.8  

 24.7  
 46.0  
 15.2  
 0.0  
 103.6  

 0.2  
 3.2  
 18.8  
 6.6  

 18.8  
 31.2  
 10.4  
 0.0  
 64.0  

 0.8  
 9.6  
 31.0  
 14.4  

 31.0  
 57.8  
 18.6  
 0.0  
 134.0  

 1.8  
 23.6  
 48.6  
 28.8  

 48.6  
 100.8  
 31.8  
 0.0  
 261.2  

 2.8  
 40.8  
 63.6  
 43.6  

 63.6  
 140.8  
 43.8  
 0.1  
 389.6  

 7.0  
 113.2  
 105.6  
 94.4  

 105.6  
 262.8  
 79.6  
 0.1  
 801.6  

Table 77 - summary of exposure concentrations (in µg Co/m3, respirable fraction) by sectors, with 
adjustment for the use of RPE.  

Sector 

R:I * 

AM 

P50 

P75 

P90 

P95 

P99 

C20.13-
20.14 
C20.30  

C10.91  Manufacture, feeds 
C19.20 
Petrochemical, catalyst 
C20.12  Manufacture  of  dyes 
and pigments 
Manufacture  of  basic 
chemicals 
Manufacture  of  paints 
and inks 
C20.59  Catalysts 
chemicals 
Formulation 
chemicals 
Pharmaceuticals 

C20.59 

C21.20 

other 

other 

and 

1:4 
1:4 
1:4 

1:4 

1:4 

1:4 

1:4 

1:4 

 0.1  
 0.9  
 1.6  

 0.0  
 0.6  
 0.8  

 0.1  
 1.0  
 1.8  

 0.2  
 1.8  
 3.9  

 0.3  
 2.6  
 6.1  

 0.7  
 4.9  
 14.3  

 0.6  

 0.3  

 0.6  

 1.4  

 2.3  

 5.5  

 1.0  

 0.3  

 0.9  

 2.5  

 4.4  

 13.2  

 0.1  

 0.0  

 0.1  

 0.2  

 0.3  

 0.7  

 0.7  

 0.2  

 0.6  

 1.5  

 2.8  

 8.2  

 0.1  

 0.0  

 0.0  

 0.1  

 0.2  

 0.9  

191 

 
 
 
 
 
 
 
 
Production of tyres  
Glass  
Ceramics 
Cutting stone 

C22.11 
C23.1  
C23.4 
C23.7 
C24.10   Steel 
C24.45  Manufacture  of  cobalt 

C25.5 
C25.61 

and cobalt alloys 
Powder metallurgy 
Surface 
metals 

treatment  of 

C25.62   Machining 
C25.73  Manufacture of tools 
C25.99  Manufacture  of  other 
metal 

fabricated 
products n.e.c. 
Production of electronic 
components 

C26.1 

1:4 
1:4 
1:4 
1:4 
1:8 
1:8 

1:8 
1:4 

1:8 
1:8 
1:8 

 0.3  
 0.7  
 1.7  
 0.6  
 0.7  
 0.7  

 0.6  
 0.8  

 0.8  
 0.6  
 0.9  

 0.1  
 0.4  
 0.9  
 0.2  
 0.3  
 0.3  

 0.4  
 0.4  

 0.6  
 0.4  
 0.5  

 0.2  
 0.8  
 1.9  
 0.6  
 0.8  
 0.7  

 0.7  
 0.9  

 1.0  
 0.7  
 1.1  

 0.6  
 1.7  
 4.0  
 1.5  
 1.6  
 1.6  

 1.3  
 1.8  

 1.5  
 1.3  
 2.2  

 1.2  
 2.6  
 6.1  
 2.5  
 2.4  
 2.4  

 1.8  
 2.8  

 2.0  
 1.8  
 3.4  

 4.2  
 5.9  
 13.8  
 6.7  
 5.5  
 5.6  

 3.5  
 6.0  

 3.2  
 3.5  
 7.5  

1:4 

 1.9  

 1.1  

 2.3  

 4.5  

 6.8  

 14.6  

C26.51   Humidity 

indicator 

1:4 

 0.1  

 0.0  

 0.1  

 0.1  

 0.2  

 0.4  

cards 
Batteries 
Engines and turbines 
Automotive 

C27.2 
C28.11 
C29.10-
30 
C30.30  Air and spacecraft 
C32.50   Medical 
devices 

and 

dental 

E38.32  Metal recovery 

Biogas 
Welding, etc.  

1:4 
1:8 
1:4 

1:8 
1:8 

1:8 
1:4 
1:2 

 0.3  
 0.8  
 0.8  

 0.8  
 1.4  

 0.1  
 0.6  
 0.4  

 0.6  
 1.0  

 0.3  
 1.0  
 0.9  

 1.0  
 1.8  

 0.7  
 1.5  
 1.8  

 1.5  
 3.2  

 1.3  
 2.0  
 2.7  

 2.0  
 4.4  

 3.5  
 3.3  
 5.9  

 3.3  
 8.2  

 0.5  
 0.00  
 6.5  

 0.3  
 0.00  
 4.0  

 0.6  
 0.01  
 8.4  

 1.0  
 0.01  
 16.3  

 1.4  
 0.02  
 24.3  

 2.5  
 0.03  
 50.1  

Source: RPA (2024) 
* R:I =respirable to inhalable ratio used for calculating respirable concentrations from inhalable. 

Table 78 - summary of exposure concentrations (in µg Co/m³, respirable fraction) by sectors, without 
adjustment for the use of RPE. 

Sector 

R:I * 

AM 

P50 

P75 

P90 

P95 

P99 

C10.91  Manufacture, feeds 
C19.20 
C20.12  Manufacture  of  dyes  and 

Petrochemical, catalyst 

C20.13-
20.14 
C20.30  

C20.59 

of 

basic 

pigments 
Manufacture 
chemicals 
Manufacture of paints and 
inks 
Catalysts 

and 

other  1:4 

1:4 
1:4 
1:4 

1:4 

1:4 

1.1 
8.2 
1.8 

5.0 

7.4 

0.4 

2.3 
14.6 
3.9 

3.5 
20.5 
6.1 

8.0 
38.8 
14.3 

11.2 

18.0 

44.0 

19.6 

35.2 

105.6 

1.2 

2.0 

5.6 

1.0 
6.8 
1.6 

0.5 
4.4 
0.8 

4.9 

2.1 

7.9 

2.5 

0.5 

0.1 

192 

 
 
 
 
 
 
 
 
other 

1:4 

5.2 

1.5 

4.6 

12.2 

22.0 

65.9 

C20.59 

chemicals 
Formulation 
chemicals 
Pharmaceuticals 
Production of tyres  
Glass  
Ceramics 
Cutting stone 
Steel 

C21.20 
C22.11 
C23.1  
C23.4 
C23.7 
C24.10  
C24.45  Manufacture of cobalt and 
cobalt alloys 
Powder metallurgy 
Surface 
metals 

C25.5 
C25.61 

treatment 

of 

C25.62   Machining 
C25.73  Manufacture of tools 
C25.99  Manufacture 

of 

other 
fabricated  metal  products 
n.e.c. 
Production  of  electronic 
components 
Humidity indicator cards 
Batteries 
Engines and turbines 
Automotive 

Air and spacecraft 

and 

dental 

C26.51  
C27.2 
C28.11 
C29.10-
30 
C30.30 
C32.50   Medical 
devices 

C26.1 

E38.32  Metal recovery 

Biogas 
Welding, etc.  

1:4 
1:4 
1:4 
1:4 
1:4 
1:8 
1:8 

1:8 
1:4 

1:8 
1:8 
1:8 

1:4 

1:4 
1:4 
1:8 
1:4 

1:8 
1:8 

1:8 
1:4 
1:2 

0.3 
2.4 
6.0 
13.4 
2.5 
5.4 
5.3 

4.8 
6.5 

6.3 
4.8 
7.4 

0.0 
0.4 
2.9 
7.0 
0.9 
2.7 
2.6 

3.0 
3.4 

4.8 
3.0 
4.0 

0.1 
1.6 
6.6 
15.5 
2.5 
6.0 
5.9 

5.7 
7.3 

7.8 
5.7 
8.7 

0.5 
4.9 
13.6 
31.9 
5.9 
12.6 
12.5 

10.3 
14.6 

12.2 
10.3 
17.8 

1.0 
9.6 
20.9 
49.1 
10.0 
19.4 
19.4 

14.5 
22.1 

15.8 
14.5 
27.1 

3.7 
33.4 
46.8 
110.1 
26.6 
43.7 
44.5 

27.9 
47.8 

25.8 
27.9 
59.8 

15.2 

8.4 

18.0 

35.8 

54.0 

116.7 

0.2 
2.6 
3.1 
3.2 

3.1 
5.8 

0.1 
0.8 
2.4 
1.7 

2.4 
3.9 

1.9 
0.00 
51.8 

1.3 
0.00 
32.0 

0.2 
2.4 
3.9 
3.6 

3.9 
7.2 

2.3 
0.01 
67.0 

0.5 
5.9 
6.1 
7.2 

6.1 
12.6 

4.0 
0.01 
130.6 

0.7 
10.2 
8.0 
10.9 

8.0 
17.6 

1.8 
28.3 
13.2 
23.6 

13.2 
32.8 

5.5 
0.02 
194.8 

10.0 
0.03 
400.8 

Source: RPA (2024) 
* R:I =respirable to inhalable ratio used for calculating respirable concentrations from inhalable. 

193 

 
 
 
 
 
 
1.5.  Current risk management measures 

Table 79 – Percentage breakdown of primary RMMs currently used by sector (row total = 100%)  

Sector 

Full 
enclosure 

Partial 
enclosure 

Open 
hood 

C10.91  Manufacture, feeds 
C19.20 

Petrochemical, 
catalyst 
C20.12  Manufacture of dyes 

and pigments 
Manufacture of basic 
C20.13-
20.14 
chemicals 
C20.30  Manufacture of paints 

and inks 
Catalysts  

Formulation 

C20.59,
1 
C20.59,
2 
C21.20 
C22.11 
C23.1 
C23.4 
C23.7 
C24.10 
C24.45  Manufacture of cobalt 

Pharmaceuticals 
Production of tyres  
Glass  
Ceramics 
Cutting stone 
Steel 

C25.5 
C25.61 

and cobalt alloys 
Powder metallurgy 
Surface treatment of 
metals 

C25.62  Machining 
C25.73  Manufacture of tools 
C25.99  Manufacture of other 

10% 
0% 

10% 

10% 

10% 

10% 

10% 

40% 
10% 
10% 
0% 
0% 
10% 
10% 

10% 
10% 

0% 
30% 
10% 

30% 
0% 

30% 

30% 

20% 

40% 

40% 

20% 
30% 
40% 
40% 
20% 
20% 
30% 

25% 
30% 

0% 
20% 
30% 

30% 
30% 

40% 

30% 

30% 

35% 

25% 

20% 
30% 
20% 
35% 
20% 
20% 
25% 

25% 
20% 

70% 
20% 
20% 

Pressurise
d or 
sealed 
cabin 
0% 
0% 

0% 

0% 

0% 

0% 

0% 

0% 
0% 
0% 
0% 
0% 
0% 
0% 

0% 
0% 

0% 
0% 
0% 

Simple 
enclosed 
cabin 

Breathing 
apparatus 

HEPA 
filter 

Simple 
mask 

Organisat
ional 
measures 

0% 
0% 

0% 

0% 

0% 

0% 

0% 

0% 
0% 
0% 
0% 
0% 
0% 
0% 

0% 
0% 

0% 
0% 
0% 

0% 
0% 

0% 

0% 

0% 

0% 

0% 

0% 
0% 
0% 
0% 
0% 
0% 
0% 

0% 
0% 

0% 
0% 
0% 

10% 
20% 

0% 

20% 

30% 

5% 

15% 

10% 
30% 
20% 
15% 
20% 
20% 
15% 

20% 
10% 

10% 
10% 
10% 

10% 
40% 

10% 

0% 

0% 

0% 

0% 

0% 
0% 
0% 
0% 
10% 
20% 
0% 

10% 
30% 

0% 
20% 
30% 

0% 
0% 

0% 

0% 

0% 

0% 

0% 

0% 
0% 
0% 
0% 
0% 
0% 
0% 

0% 
0% 

0% 
0% 
0% 

General 
dilution 
ventilatio
n 
10% 
10% 

10% 

10% 

10% 

10% 

10% 

10% 
0% 
10% 
10% 
10% 
10% 
20% 

10% 
0% 

0% 
0% 
0% 

No 
ventilatio
n 

0% 
0% 

0% 

0% 

0% 

0% 

0% 

0% 
0% 
0% 
0% 
20% 
0% 
0% 

0% 
0% 

20% 
0% 
0% 

 
 
C26.1 

fabricated metal 
products n.e.c. 
Production of 
electronic components 
ad boards 
C26.51  Humidity indicator 

cards 
Batteries 
Engines and turbines 
Automotive 

C27.2 
C28.11 
C29.10-
30 
C30.30  Air and spacecraft 
C32.50  Medical and dental 
devices 
E38.21   Biogas 
E38.32  Metal recovery 

Welding 

Source: RPA (2024), stakeholder survey 

10% 

30% 

10% 

0% 

0% 

0% 

30% 

10% 

0% 

10% 

0% 

10% 

10% 
20% 
20% 

10% 
0% 

10% 
0% 

30% 

45% 
30% 
30% 

30% 
20% 

20% 
20% 

20% 

20% 
25% 
25% 

25% 
25% 

25% 
25% 

0% 

0% 
0% 
0% 

0% 
0% 

0% 
0% 

0% 

0% 
0% 
0% 

0% 
0% 

0% 
0% 

0% 

0% 
0% 
0% 

0% 
0% 

0% 
0% 

0% 

15% 
15% 
15% 

15% 
15% 

15% 
45% 

20% 

0% 
0% 
0% 

20% 
20% 

20% 
0% 

0% 

0% 
0% 
0% 

0% 
0% 

0% 
0% 

20% 

10% 
10% 
10% 

0% 
20% 

10% 
10% 

0% 

0% 
0% 
0% 

0% 
0% 

0% 
0% 

195 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.6.  Risk management measures required to achieve compliance 

Table 80: RMMs required to meet policy options (values = number of processes requiring RMM) 

Sector (number of work 
processes) 

No action 
required 

Full 
enclosure 

Partial 
enclosu
re 

Open 
hood 

Pressurise
d or sealed 
cabin 

Simple 
enclosed 
cabin 

Self-cont. 
Breathin
g 
apparatu
s 

Powered 
air-
purifying 
resp. 

HEPA 
filter 

Simple 
mask 

Reduce 
amount of 
substance 

General 
dilution 
ventilation 

10% (2) 

15% (3) 

60% (12) 

20% (4) 

25% (5) 

20% (4) 

14% (1) 

50% (2) 

14% (1) 

43% (3) 

29% (2) 

14% (1) 

100% (1) 

83% (5) 

5% (1) 

30% (6) 

25% (5) 

25% (1) 

25% (1) 

75% (3) 

100% (7) 

14% (1) 

50% (12) 

13% (3) 

8% (2) 

25% 
(5) 
75% 
(3) 
14% 
(1) 

4% 
(1) 

Policy option 20 / 4.2 µg/m3  
C19.20 Manufacture of refined 
petroleum products (1) 
C20.12 Manufacture of dyes and 
pigments (6) 
C20.13 Manufacture of other 
inorganic basic chemicals (20) 
C20.14 Manufacture of other 
organic basic chemicals (4) 
C20.30 Manufacture of paints, 
varnishes and similar coatings, 
printing ink and mastics (7) 
C20.59 Manufacture of other 
chemical products n.e.c. (24) 
C21.20 Manufacture of 
pharmaceutical preparations (1) 
C23.19 Manufacture and 
processing of other glass, including 
technical glassware (1) 
C23.4 Manufacture of other 
porcelain and ceramic products 
(15) 
C24.10 Manufacture of basic iron 
and steel and of ferro-alloys (4) 
C24.45 Other non-ferrous metal 
production (16) 
C25.61 Treatment and coating of 

100% (1) 

100% (1) 

100% (15) 

75% (3) 

50% (8) 

44% (7) 

13% (2) 

6% (1) 

25% (4) 

13% (2) 

13% (2) 

25% (1) 

25% (1) 

4% (1) 

25% (1) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
metals (4) 
C25.73 Manufacture of tools (40) 

C26.1 Manufacture of electronic 
components (2) 
C27.2 Manufacture of batteries and 
accumulators (10) 
C32.50 Manufacture of medical 
and dental instruments and 
supplies (4) 
F42 Civil engineering (4) 
Grand Total (163) 

Policy option 10 / 2.5 µg/m3  
C19.20 Manufacture of refined 
petroleum products (1) 
C20.12 Manufacture of dyes and 
pigments (6) 
C20.13 Manufacture of other 
inorganic basic chemicals (20) 
C20.14 Manufacture of other 
organic basic chemicals (4) 
C20.30 Manufacture of paints, 
varnishes and similar coatings, 
printing ink and mastics (7) 
C20.59 Manufacture of other 
chemical products n.e.c. (24) 
C21.20 Manufacture of 
pharmaceutical preparations (1) 
C23.19 Manufacture and 
processing of other glass, including 

15% (6) 

60% (24) 

28% 
(11) 

18% 
(7) 

8% (3) 

5% (2) 

25% (10) 

3% (1) 

23% (9) 

15% (6) 

90% (9) 

20% (2) 

20% (2) 

25% (1) 

25% (1) 

50% (2) 

25% (1) 

43% (70) 

25% (1) 
26% (43) 

15% 
(24) 

10% 
(17) 

100% 
(1) 

50% (3) 

20% (4) 

30% (6) 

15% (3) 

71% (5) 

14% (1) 

38% (9) 

17% (4) 

4% (1) 

100% 
(1) 
83% 
(5) 
15% 
(3) 

14% 
(1) 

4% 
(1) 

4% (7) 

2% (4) 

2% (3) 

20% (33) 

7% (11) 

12% 
(19) 

1% (2) 

8% (13) 

20% (4) 

25% (5) 

40% (8) 

20% (4) 

20% (4) 

14% (1) 

14% (1) 

43% (3) 

29% (2) 

14% (1) 

8% (2) 

13% (3) 

100% (1) 

197 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
technical glassware (1) 
C23.4 Manufacture of other 
porcelain and ceramic products 
(15) 
C24.10 Manufacture of basic iron 
and steel and of ferro-alloys (4) 
C24.45 Other non-ferrous metal 
production (16) 
C25.61 Treatment and coating of 
metals (4) 
C25.73 Manufacture of tools (40) 

C26.1 Manufacture of electronic 
components (2) 
C27.2 Manufacture of batteries and 
accumulators (10) 
C32.50 Manufacture of medical 
and dental instruments and 
supplies (4) 
F42 Civil engineering (4) 
Grand Total (163) 

Policy option 5 / 1.5 µg/m3  
C19.20 Manufacture of refined 
petroleum products (1) 
C20.12 Manufacture of dyes and 
pigments (6) 
C20.13 Manufacture of other 
inorganic basic chemicals (20) 
C20.14 Manufacture of other 
organic basic chemicals (4) 

100% (15) 

25% (4) 

44% (7) 

31% (5) 

25% (1) 

13% (5) 

33% (13) 

13% (5) 

19% 
(3) 

13% 
(5) 

13% (2) 

13% (2) 

25% (4) 

13% (2) 

13% (2) 

13% (2) 

5% (2) 

5% (2) 

15% (6) 

5% (2) 

20% (8) 

3% (1) 

15% (6) 

25% (1) 

80% (8) 

10% (1) 

10% (1) 

10% (1) 

30% (3) 

10% (1) 

31% (51) 

21% (34) 

10% 
(17) 

12% 
(19) 

100% 
(1) 
33% (2) 

100% 
(1) 

6% (9) 

5% (8) 

2% (3) 

15% (24) 

4% (6) 

10% 
(17) 

4% (6) 

8% (13) 

100% (1) 

5% (1) 

35% (7) 

10% (2) 

20% 
(4) 

10% (2) 

20% (4) 

15% (3) 

198 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C20.30 Manufacture of paints, 
varnishes and similar coatings, 
printing ink and mastics (7) 
C20.59 Manufacture of other 
chemical products n.e.c. (24) 
C21.20 Manufacture of 
pharmaceutical preparations (1) 
C23.19 Manufacture and 
processing of other glass, including 
technical glassware (1) 
C23.4 Manufacture of other 
porcelain and ceramic products 
(15) 
C24.10 Manufacture of basic iron 
and steel and of ferro-alloys (4) 
C24.45 Other non-ferrous metal 
production (16) 
C25.61 Treatment and coating of 
metals (4) 
C25.73 Manufacture of tools (40) 

C26.1 Manufacture of electronic 
components (2) 
C27.2 Manufacture of batteries and 
accumulators (10) 
C32.50 Manufacture of medical 
and dental instruments and 
supplies (4) 
F42 Civil engineering (4) 
Grand Total (163) 

14% (1) 

14% (1) 

14% (1) 

29% (2) 

29% (2) 

14% (1) 

21% (5) 

8% (2) 

4% (1) 

8% 
(2) 

13% (3) 

13% (3) 

100% (1) 

53% (8) 

40% 
(6) 

87% 
(13) 

19% (3) 

50% (8) 

38% (6) 

25% (1) 

10% (4) 

33% (13) 

5% (2) 

60% (6) 

20% (2) 

20% (2) 

19% 
(3) 

3% 
(1) 

10% 
(1) 

25% (4) 

6% (1) 

25% (4) 

13% (2) 

6% (1) 

13% (2) 

6% (1) 

25% (1) 

13% (5) 

3% (1) 

3% (1) 

3% (1) 

3% (1) 

3% (1) 

10% (1) 

10% (1) 

10% (1) 

13% (21) 

20% (32) 

15% 
(25) 

11% 
(18) 

4% (7) 

1% (2) 

6% (10) 

7% (12) 

2% (4) 

11% 
(18) 

6% (9) 

2% (3) 

199 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Policy option 1 / 0.5 µg/m3  
C19.20 Manufacture of refined 
petroleum products (1) 
C20.12 Manufacture of dyes and 
pigments (6) 
C20.13 Manufacture of other 
inorganic basic chemicals (20) 
C20.14 Manufacture of other 
organic basic chemicals (4) 
C20.30 Manufacture of paints, 
varnishes and similar coatings, 
printing ink and mastics (7) 
C20.59 Manufacture of other 
chemical products n.e.c. (24) 
C21.20 Manufacture of 
pharmaceutical preparations (1) 
C23.19 Manufacture and 
processing of other glass, including 
technical glassware (1) 
C23.4 Manufacture of other 
porcelain and ceramic products 
(15) 
C24.10 Manufacture of basic iron 
and steel and of ferro-alloys (4) 
C24.45 Other non-ferrous metal 
production (16) 
C25.61 Treatment and coating of 
metals (4) 
C25.73 Manufacture of tools (40) 

C26.1 Manufacture of electronic 

100% 
(1) 

100% 
(1) 
50% 
(3) 
20% 
(4) 

8% 
(2) 

100% (1) 

50% (3) 

35% (7) 

29% (2) 

21% (5) 

93% (14) 

100% (1) 

100% (1) 

50% (3) 

20% (4) 

20% (4) 

15% (3) 

29% (2) 

8% (2) 

17% (4) 

17% (4) 

13% (3) 

100% 
(15) 

25% (4) 

75% (12) 

38% (6) 

25% (1) 

40% (16) 

3% (1) 

44% 
(7) 

3% 
(1) 

38% (6) 

13% (2) 

38% (6) 

25% (4) 

13% (2) 

25% (4) 

38% (6) 

13% (2) 

25% (1) 

18% (7) 

3% (1) 

3% (1) 

5% (2) 

200 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
components (2) 
C27.2 Manufacture of batteries and 
accumulators (10) 
C32.50 Manufacture of medical 
and dental instruments and 
supplies (4) 
F42 Civil engineering (4) 
Grand Total (163) 

50% (5) 

40% (4) 

60% (6) 

10% 
(1) 

30% (3) 

50% (5) 

40% (4) 

6% (10) 

39% (64) 

9% 
(14) 

12% 
(19) 

6% (10) 

2% (4) 

10% (17)  11% (18)  18% (30) 

4% (7) 

9% (14) 

1% (2) 

Source: RPA (2024), stakeholder survey 

201 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.7.  National limit value(s) 

Table 81 - current OELs and STELs in EU Member States and selected non-EU countries 
Specification of OEL 

STEL (µg/m³) 

OEL (µg/m³) 

Country 

Specification of 
STEL 

EU Member States 
Austria 1,2,3 

Belgium 1,2,4 

Belgium 4 

Bulgaria 5 

Croatia 6 

Cyprus 7 

Czechia 8 

Denmark 1,2,9 

Estonia 10 

Finland 1,2,11 

France 2,12 

Germany 1,2,13 

Greece 14 
Hungary 1,2,15 

Ireland 1,2,16 

Italy 17 

100 ** 

100 ** 

100 ** 

5 (R) ** 

100 (I) * 

Cobalt and cobalt alloys, 
cobalt oxide, cobalt 
sulphate and cobalt 
sulphide 
- TRK value#, Carc, Srd, 
Sk 
A value of 0.5 for certain 
processes 
20 (I, V) **  Cobalt metal (dust and 
fume) 
- Carc 
Hardmetal of cobalt and 
tungsten carbide, as Co 
Cobalt and inorganic 
compounds 
Cobalt and its compounds 
- Srd 
Metal dust and fumes, 
total dust 
Cobalt and its compounds 
- Carc, Repro, S 
Cobalt, powder, dust, 
smoke, and inorganic 
compounds 
Carc 
Cobalt and its inorganics 
compounds 
- S 
Cobalt and its inorganics 
compounds 
Cobalt compounds, 
excluding hardmetals 
Recommendation derived 
by ANSES 
Cobalt and cobalt 
compounds classified as 
Carc 1A and 1B 

4 (R) § * 
0.2 (R) $ 

20 (I) ^^ 

50 (R) * 

10 ** 

2.5 ^ 

50 * 

20 (I) ! 
100 * 
20 15 * 

20 ^ 

- 

Cobalt and its compounds 
Cobalt and its inorganic 
compounds, S 15 
A value of 0.1 mg/m³ 
applies for cobalt and its 
compounds 1,2 
Cobalt and its 
compounds, S 

400 (I) * 

- TRK value#, 
Carc, Srd, Sk 

- 

- 

- 

- 

- 

0.1 (R) * 

- Carc, Repro, S 

20 ** 

- powder, dust, and 
smoke, Carc 

- 

- 

12.5 ^ 

- recommendation 
derived by ANSES 

- Cobalt 
compounds 
classified as Carc 
1A and 1B, 15 min 
average value 

- Cobalt and its 
compounds 1,2 

40 (R) § * 

- 
400 * 

- 

- 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Latvia 1,2,18 

Lithuania 19 

Luxembourg 20 
Malta 21 
Netherlands 1,2,22 
Poland 1,2,23 

Portugal 24 
Romania 1,2,25 

Slovakia 26 

- 
50 * 

50 ** 

Slovenia 27 
Spain 1,2,28 

- 
20 (I) ^^ 

Sweden 1,2,29 

20 (I) ** 

European Union 
RAC 2 

Candidate countries 
Albania 45 
Bosnia and 
Herzegovina 46 
Georgia 47 
Moldova 48 49 

- 
1 (I) 
0.5 (R) 

- 
- 

- 
50 * 

Montenegro 50 
North Macedonia 51 

- 
500 (I) 

- Cobalt, cobalt (II) and 
(III) oxide 
Cobalt and its inorganic 
compounds 
- Carc, S 

500 ** 

50 ** 

- 
- 

20 (D, F) **  Cobalt (dust and smoke) 
Cobalt and its inorganic 
compounds 

20 ** 

- 

- 

- 
- 
- 
- 

- 
100 * 

- Cobalt, 15 min 
average value 

- 

- 
- 

- 

- 
- 

- 
- 

- 
100* 

- S 

- 
- 

Cobalt, cobalt oxide,  

Cobalt and its 
compounds, total dust 
- S 

Cobalt and inorganic 
cobalt compounds  
- S, Carc (cobalt and 
specific compounds) 
Cobalt and its inorganic 
compounds 
- Carc, S, Sk 

Cobalt and its inorganic 
compounds 
- Srd 

- S 
Cobalt (oxide of cobalt) 
- Carc, S 
(Cobalt in urine 15 µg/l 
Sampling time: at the end 
of the work shift or work 
week) 

Cobalt (metal, cobalt 
oxide and cobalt sulfide) - 
obtaining powder from 
coal catalysts, carbide 
substrates and 
and powder, compaction 
and mechanical treatment 
of magnets (prep 

203 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
unsintered pieces) 
- Others 

100 (I) 
- 
- 
- 

- 

Serbia 52 
Turkey 40 
Ukraine 53 
EU candidate countries 
Albania  
Bosnia and 
Herzegovina 
Georgia 
Moldova,  
Montenegro 
North Macedonia,   
Serbia, 
Turkey 40 
Ukraine 
Non-EU countries 
Australia 1,30 
Brazil 31 
Canada, Ontario 32 
Canada, Québec1,33 
China 1 

50 (D, F) *** 
- 
- 
20 *** 
50% 

India 34 
Japan, MHLW 1,35 
Japan, JOSH 1,36 
Norway 1,2, 37 

Russia 38 

- 
20 *** 
50 ^^^ 
20 (T)& ^^ 

4% 

1% 

South Korea 1 
Switzerland 1,2, 39 

20% 
50 (I) * 

United Kingdom 1,2,41 

100 * 

USA, ACGIH 42 
USA, NIOSH 1,43,$$ 
USA, OSHA 1,2,44 
Source: RPA (2024)  
Notes: 
* Binding value according to country-specific source 

20 (I) ^ 
50 (D, F) ^ 
100 (D, F) * 

- S 

- Carc, S 

- Carc, Srd 
- Cobalt and its inorganic 
compounds, except Co(II) 
- Cobalt, acceptable risk 
under daily exposure (at 
least 24), Sk 
- Cobalt, acceptable risk 
under chronic exposure 
(at least 1 year), Sk 

- Cobalt and its 
compounds, Carc, Repro, 
S, Sk 
- Cobalt and its 
compounds, Carc (only 
for cobalt dichloride and 
sulphate), S 
- Carc, Srd 
- Cobalt 
- Cobalt 

204 

- 15 min average 
value 

- 
- 
- 

- 

- 
- 
- 
- 
100% 

- 
- 
- 
- 

- 

- 
- 

- 

- 
- 
- 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
** Binding value according to reply of member state authority on questionnaire 
*** Binding value according to the Final report for OEL/STEL deriving systems from 2018 (Available at: https://bit.ly/3PKDhbS, accessed on 
05.07.2023). Status was not checked since 2018. 
^ Indicative value according to country-specific source 
^^ Indicative value according to reply of member state authority on questionnaire 
^^^ Indicative value according to the Final report for OEL/STEL deriving systems from 2018 
(Available at: https://bit.ly/3PKDhbS, accessed on 05.07.2023). Status was not checked since 2018. 
% According to (country-specific) source unclear if value is binding or indicative 
& Information according to reply of member state authority on questionnaire 
! The adoption of this value is currently being discussed.  

(T) Total dust 
ANSES = French Agency for Food, Environmental and Occupational Health & Safety 
RAC = Committee for Risk Assessment 
MHLW = Ministry of Health, Labour and Welfare 
JSOH = Japan Society for Occupational Health 
ACGIH = American Conference of Governmental Industrial Hygienists 
OSHA = Occupational Safety and Health Administration 
NIOSH = National Institute for Occupational Safety and Health 
TRK value= Technical Guidance Concentrations (‘Technische Richtkonzentrationen’) in Austria 
(I) = inhalable fraction/aerosol 
(R) = respirable fraction/aerosol 
(V) = vapour 
(D) = dust 
(F) = fume 
Carc = notation for carcinogenicity. Where a more detailed notation for carcinogenicity was given, the following notations were reported: 
Repro = notation for reproductive toxicity assigned 
S = notation for sensitisation assigned. Where a more detailed notation for sensitisation was given, the following notation was reported: 
Srd = respiratory and skin/dermal sensitisation 
Sk = skin notation assigned or danger of skin absorption 
- no value available  
§ Workplace exposure concentration corresponding to the proposed tolerable cancer risk  
$ Workplace exposure concentration corresponding to the proposed preliminary acceptable cancer risk 
$$ For NIOSH recommended exposure limits (RELs), ‘TWA’ indicates a time-weighted average concentration for up to a 10-hour workday during a 
40-hour workweek.’; Online: https://www.cdc.gov/niosh/npg/pgintrod.html, assessed December 2022 
# TRK value (‘Technische Richtkonzentration’, Technical Guidance Concentration), based on technical feasibility  

Sources: 
1: Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) GESTIS– International Limit Values. Available at: 
http://limitvalue.ifa.dguv.de/, accessed on 02.12.2022 
2: RAC, Committee for Risk Assessment (RAC, 2022).  
3: Austria (2021) Grenzwerteverordnung 2021 – GKV. Available at: 
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20001418, accessed on 02.12.2022 
4: Belgium (2021) List of limit values (Titel 1. – Chemische agentia. and Titel 2. – Kankerverwekkende, mutagene en reprotoxische agentia). 
Available at: https://werk.belgie.be/nl/themas/welzijn-op-het-werk/algemene-beginselen/codex-over-het-welzijn-op-het-werk, accessed on 02.12.2022 
5: Bulgaria (2021) List of limit values. Available at: https://www.lex.bg/laws/ldoc/2135477597, accessed on 05.12.2022 
6: Croatia (2021) List of limit values. Available at: https://narodne-novine.nn.hr/clanci/sluzbeni/2021_01_1_10.html, accessed on 05.12.2022 
7: Cyprus (2021) Legislation on chemical agents and legislation on carcinogenic-mutagenic agents. Available at: 
https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/E3237CC15BD91575C2257E030029E9FF?OpenDocument and 
https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/D74ACEE6A814B7EAC2257E03002A76C9?OpenDocument, accessed on 05.12.2022 
Limit value indicated in Member State survey 
8: Czechia (2022) List of limit values. Available at: https://www.tzb-info.cz/pravni-predpisy/narizeni-vlady-c-361-2007-sb-kterym-se-stanovi-
podminky-ochrany-zdravi-pri-praci, accessed on 05.12.2022 
9: Denmark (2022) List of limit values. Available at: https://www.retsinformation.dk/eli/lta/2022/1054, accessed on 05.12.2022 
10: Estonia (2022) List of limit values. Available at: https://www.riigiteataja.ee/aktilisa/1120/3202/2025/VV_30m_lisa.pdf#, accessed on 05.12.2022 
11: Finland (2020) List of limit values. Available at: https://julkaisut.valtioneuvosto.fi/handle/10024/162457, accessed on 05.12.2022 

205 

 
 
 
 
 
 
12: France (2022) List of limit values. Available at: https://www.inrs.fr/media.html?refINRS=outil65 and recommendation by ANSES (2018). 
Available at: https://www.anses.fr/en/system/files/VLEP2007SA0431RaEN.pdf, accessed on 05.12.2022 
13: Germany (2022) List of limit values for carcinogenic hazardous substances (TRGS 910). Available at: 
https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-Regeln/Regelwerk/TRGS/pdf/910/910-cobalt.pdf?__blob=publicationFile&v=3 / 
accessed 5 April 2023. 
14: Greece (2019) List of limit values. Available at: https://www.elinyae.gr/sites/default/files/2019-10/oriakes%20times%202019_L_0.pdf, accessed 
on 05.12.2022 
15: Hungary (2022) List of limit values. Available at: https://net.jogtar.hu/jogszabaly?docid=a2000005.itm, accessed on 05.12.2022 
16: Ireland (2021) List of limit values. Available at: 
https://www.hsa.ie/eng/publications_and_forms/publications/chemical_and_hazardous_substances/2021-code-of-practice-for-the-chemical-agents-
and-carcinogens-regulations.pdf, accessed on 05.12.2022 
17: Italy (2022) List of limit values and amendments. Available at: https://www.ispettorato.gov.it/it-it/strumenti-e-servizi/Documents/TU-81-08-Ed.-
Agosto-2022.pdf, accessed on 06.12.2022 
18: Latvia (2022) List of limit values. Available at: https://likumi.lv/doc.php?id=157382&from=off, accessed on 06.12.2022 
19: Lithuania (2022) List of limit values. Available at: https://www.e-tar.lt/portal/lt/legalAct/TAR.8012ED3EA143/asr, accessed on 06.12.2022 
20: Luxembourg (2020) List of limit values (2018) and list of carcinogens and mutagens (2020). Available at: 
http://legilux.public.lu/eli/etat/leg/rgd/2018/07/20/a684/jo and http://legilux.public.lu/eli/etat/leg/rgd/2020/01/24/a37/jo, accessed on 06.12.2022 
21: Malta (2021) List of limit values. Available at: https://legislation.mt/eli/sl/424.24/eng/pdf, accessed on 06.12.2022 
22: Netherlands (2022) List of limit values. Available at: https://wetten.overheid.nl/BWBR0008587/2022-07-01#BijlageXIII, accessed on 06.12.2022 
23: Poland (2021) List of limit values from 2018 and amendments in 2020 and 2021. Available at: 
https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20180001286/O/D20181286.pdf, 
http://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20200000061, and 
https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20210000325/O/D20210325.pdf, accessed on 06.12.2022 
24: Portugal (2022) List of limit values. Available at: https://dre.pt/dre/legislacao-consolidada/decreto-lei/2012-115495237, accessed on 07.12.2022 
25: Romania (2021) List of limit values. Available at: https://legislatie.just.ro/Public/DetaliiDocument/75978, accessed on 07.12.2022 
26: Slovakia (2020) List of limit values. Available at: https://www.epi.sk/zz/2006-355, accessed on 07.12.2022 
27: Slovenia (2021) List of limit values. Available at: http://www.pisrs.si/Pis.web/pregledPredpisa?id=PRAV14252, accessed on 07.12.2022 
28: Spain (2022) List of limit values. Available at: https://www.insst.es/el-instituto-al-dia/limites-de-exposicion-profesional-para-agentes-quimicos-
2022, accessed on 07.12.2022 
29: Sweden (2022) List of limit values and amendments. Available at: https://www.av.se/arbetsmiljoarbete-och-
inspektioner/publikationer/foreskrifter/hygieniska-gransvarden-afs-20181-foreskrifter/, accessed on 07.12.2022 
30: Australia (2022) List of limit values. Available at: https://www.safeworkaustralia.gov.au/doc/workplace-exposure-standards-airborne-
contaminants-2022, accessed on 07.12.2022 
31: Brazil (2021) List of limit values. Available at: https://www.guiatrabalhista.com.br/legislacao/nr/nr-15-anexo-11.pdf, accessed on 07.12.2022 
32: Canada, Ontario (2020) List of limit values. Available at: https://www.ontario.ca/laws/regulation/900833, accessed on 07.12.2022 
33: Canada, Québec (2022) List of limit values. Available at: https://www.legisquebec.gouv.qc.ca/en/document/cr/S-2.1,%20r.%2013, accessed on 
07.12.2022 
34: India (2007) List of limit values. Available at: https://dgfasli.gov.in/en/book-page/permissible-levels-certain-chemical-substancesin-work-
environment, accessed on 08.12.2022 
35: Japan (2022) List of limit values. Available at: 
https://www.nite.go.jp/en/chem/chrip/chrip_search/intSrhSpcLst?slIdxNm=&slScNm=RJ_04_061&slScCtNm=&slScRgNm=&ltCatFl=&slMdDplt=
0&ltPgCt=200&stMd, accessed on 12.12.2022 
36: Japan - JOSH (2022) List of limit values. Available at: https://www.sanei.or.jp/english/files/topics/oels/oel_en.pdf, accessed on 08.12.2022 
37: Norway (2022) List of limit values. Available at: https://lovdata.no/dokument/SF/forskrift/2011-12-06-1358#KAPITTEL_8, accessed on 
10.12.2022 
38: Russia (2021) List of limit values. Available at: http://publication.pravo.gov.ru/Document/View/0001202102030022?index=21&rangeSize=1, 
accessed on 10.12.2022 
39: Switzerland (2022) List of limit values. Available at: https://www.suva.ch/de-ch/services/grenzwerte#gnw-location=%2F, accessed on 
10.12.2022 
40: Turkey (2013) List of limit values. Available at: https://www.resmigazete.gov.tr/eskiler/2013/08/20130812-1.htm, accessed on 10.12.2022 
41: United Kingdom (2020) List of limit values. Available at: https://www.hse.gov.uk/pubns/priced/eh40.pdf and 
https://www.hse.gov.uk/pubns/priced/l132.pdf, accessed on 10.12.2022 
42: ACGIH, American Conference of Governmental Industrial Hygienists (2022), TLVs and BEIs Based on the Documentation of the Threshold Limit 
Values for Chemical Substances and Physical Agents and Biological Exposure Indices. 
43: USA, NIOSH (2022) List of limit values. Available at: https://www.cdc.gov/niosh/index.htm, accessed on 10.12.2022 
44: USA, OSHA (2022) List of limit values. Available at: https://www.osha.gov/dsg/annotated-pels/tablez-1.html, accessed on 10.12.2022 

206 

 
 
 
 
45: Albania (2014) Albania (2014) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/115604/ALB-
115604.pdf; accessed on 26.03.2024 
46: Bosnia and Herzegovina (2020) Law on protection at work - part one. Available at: 
https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/112339/BIH-112339.pdf; accessed on 26.03.2024 
47: Georgia (2014) List of permissible concentrations of metals in the air of the working area. Available at: 
https://matsne.gov.ge/ka/document/view/2198163?publication=0, accessed on 28.03.2024 
48: Moldova (2013) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/97247/PDF.pdf, accessed on 
26.03.2024 
49: Moldova (2013) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/97247/PDF.pdf, accessed on 
26.03.2024 
50: Montenegro (2023) List of carcinogens and mutagens. Available at:  and https://www.gov.me/dokumenta/d41be940-6c22-499d-8c32-
3619e0a6d332, accessed on 27.03.2024 
51: North Macedonia (2010) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/94988/MKD-94988.pdf, 
accessed on 27.03.2024 
52: Serbia (2018) List of limit values. Available at: http://www.socijalnoekonomskisavet.rs/cir/publikacije/propisi%20bzr.pdf, accessed on 
28.03.2024 
53:    Ukraine  (2020)  List  of  limit  values  and  amendments  (2023).  Available  at:  https://zakon.rada.gov.ua/laws/show/z0741-20#Text,  accessed  on 
28.03.2024 

2.  PAHS 

2.1.  Relevant sectors with exposed workers 

NACE definition 

Table 82 - relevant sectors with risk of exposure to PAHs 
Refined short name 
for relevant sub-sector 
Fish  and  meat  smoke 
houses 

Smoking  of  fish  and  meat  for 
preservation purposes 

Description of activity 

NACE code 

C10.13, 
C10.20  

C16.1 

C19.10 

C19.2 

C20.13 

C20.14 

C23.2 

and 

and 
fish, 
and 

Production  of  meat 
and 
poultry  meat 
products; 
Processing 
preserving  of 
crustaceans 
molluscs 
Sawmilling 
planing of wood 
Manufacture  of  coke 
oven products 
Manufacture 
refined 
products 
Manufacture  of  other 
inorganic 
basic 
chemicals 
Manufacture  of  other 
organic 
basic 
chemicals 
Manufacture 
refractory products 

of 
petroleum 

of 

preservation 

Wood 
(creosote) 
Coking plants 

Impregnation  of  wood  with 
creosote  
Carbonation of coal 

Petroleum refineries 

Refining of crude oil 

Manufacture  of  carbon 
black 

Coal tar distillation 

of 
aromatic 
to  manufacture 

Reaction 
compounds 
carbon black 
Refining of coal tar 

Manufacture 
refractory products 

of 

of 

Manufacture 
refractory 
products  with  coal  tar  pitch 
high-temperature (CTPht) 

207 

 
 
 
 
 
C23.99a 

C23.99b 

Manufacture  of  other 
non-metallic  mineral 
products n.e.c 

Manufacture 
bituminous products 

of 

Graphite  and  carbon 
electrodes manufacture 

C24.1 

C24.45 

Manufacture  of  basic 
iron  and  steel  and  of 
ferro-alloys 
Other 
metal production 

non-ferrous 

Steel 
foundries, ferroalloys 

and 

iron 

Other 
non-ferrous 
metallurgical processes 

C24.42 

Aluminium 
production 

Manufacture 
aluminium 

of 

C24.5 

Casting of metals 

Casting of metals 

and 

shaping 
at 

Use of bitumen to manufacture 
road  paving 
roofing 
products 
Use  of  carbon  solids  and 
binding  agents  such  as  CTPht 
to  manufacture  graphite  and 
carbon  electrodes,  via  baking, 
impregnation, 
and 
high 
graphitisation 
temperatures 
Use of coal, coal powders and 
graphite 
to 
manufacture iron and steel 
Use  of  Söderberg  electrodes, 
briquettes  or  paste  at  high 
to  manufacture 
temperature 
non-ferrous 
and 
products 
Use  of  carbon  and  graphite 
to  manufacture 
electrodes 
aluminium 
Casting  of  metals 
moulds 

electrodes 

in  sand 

metals 

D35.11 

E38.2 

E39 

F42.11 

F42.12 

G45.2 

N81.22 

O84.25 

of 

Production 
electricity 
Waste  treatment  and 
disposal 
Remediation  activities 
and 
other  waste 
management services 
Construction  of  roads 
and motorways 
of 
Construction 
railways 
and 
underground railways 
and 
Maintenance 
repair 
of  motor 
vehicles 
Other  building  and 
cleaning 
industrial 
activities 
Fire service activities 

Coal fired power plants   Use  of  coal 

to  generate 

Waste incineration 

Soil remediation 

Road paving  

electricity 
Incineration  of  municipal  or 
hazardous waste 
Thermal  soil  remediation  of 
soil  contaminated  with  PAH, 
may include excavation 
Paving or roads with bitumen 

Welding of train tracks  Welding 

of 

train 

tracks 

impregnated with creosote oil 

vehicle 
Motor 
maintenance and repairs 

Maintenance  and  repair  of 
motorised vehicles  

Chimney sweeps 

Cleaning of chimneys 

Firefighters 

Extinguishing  and  monitoring 
fires 

Source: RPA (2024) 

208 

 
 
 
 
 
2.2.  Estimated number of enterprises with exposed workers in the EU 

Table 83 – estimated number of EU enterprises with exposed workers by sector and by size of enterprise  

Sector 

Seafood smokehouses 
Wood preservation (creosote) 
Coking plants 
Petroleum refineries 

C10.13  Meat and poultry smokehouses 
C10.2 
C16.1 
C19.1 
C19.2 
C20.13  Manufacture of carbon black 
C20.14 
C23.2 
C23.99a  Manufacture of bituminous products 
C23.99b  Graphite and carbon electrode 

Coal tar distillation 
Manufacture of refractory products 

manufacture 
Steel and iron foundries, ferroalloys 

C24.1 
C24.42  Manufacture of aluminium 
C24.45 
C24.5 
D35.11 
E38.2 
E39 
F42.11 
F42.12  Welding of railway sleepers 
G45.2 

Other non-ferrous metallurgy 
Casting of metals 
Coal fired power plants 
Waste incineration 
Soil remediation 
Road paving 

Motor vehicles maintenance and 
repairs 
Chimney sweeps 
Firefighters 

N81.22 
O84.25 
Total 
Source: RPA (2024) 

Total 
number of 
enterprise
s 

 210  
 330  
 40  
 55  
 81  
 25  
 7  
 5  
 1,180  
 22  

 2,769  
 9  
 80  
 4,742  
 196  
 650  
 3,378  
 30,949  
 2,016  
 374,183  

 19,381  
 758  
441,066 

Number of enterprises with exposed 
workers 
Medium    
50-249 
employees 

Small      
<50 
employees 

Large    
>249 
employees 

 194  
 287  
 39  
 48  
 30  
 -    
 -    
 4  
 1,057  
 -    

 2,523  
 -    
 67  
 4,017  
 126  
 597  
 3,280  
 29,375  
 1,914  
 373,527  

 19,381  
 N/A  
436,466 

 13  
 36  
 1  
 2  
 12  
 20  
 3  
 1  
 99  
 -    

 112  
 3  
 8  
 541  
 45  
 43  
 88  
 1,285  
 83  
 606  

 -    
 N/A    
 3,001  

 3  
 7  
 -    
 5  
 39  
 5  
 4  
 -    
 24  
 22  

 134  
 6  
 5  
 184  
 25  
 10  
 10  
 289  
 19  
 50  

 -    
 N/A    
 841 

2.3.  Estimated number of exposed workers in the EU 

Table 84 – estimated number of workers in the EU exposed to PAHs 

Sector 

Number of 
exposed 
workers 

Number of 
companies 
with 
exposed 
workers 

Total 
number of 
workers in 
companies 

Number 
exposed per 
company 

Percentage 
exposed in 
companies 

C10.13  Meat and 

 713  

 210  

 4,753  

 3  

15% 

209 

 
 
 
 
 
 
C10.2 

C16.1 

C19.1 
C19.2 

poultry 
smokehouses 
Seafood 
smokehouses 
Wood 
preservation 
(creosote) 
Coking plants 
Petroleum 
refineries 

 1,626  

 1,000  

 2,516  
20,266  

C20.13  Manufacture of 

 1,020  

C20.14 

C23.2 

carbon black 
Coal tar 
distillation 
Manufacture of 
refractory 
products 

 750  

 86  

 330  

 10,841  

 40  

 1,200  

 55  
 81  

 25  

 7  

 5  

 2,795  
 57,941  

 3,400  

 2,500  

 171  

 5  

 25  

 46  
 179  

 41  

 107  

 17  

15% 

83% 

90% 
25% 

30% 

30% 

50% 

C23.99a  Manufacture of 

 5,800  

 1,180  

 31,994  

 5  

18% 

bituminous 
products 

C23.99b  Graphite and 

 1,001  

 22  

 12,500  

 46  

8% 

C24.1 

carbon electrode 
manufacture 
Steel and iron 
foundries, 
ferroalloys 

C24.42  Manufacture of 

C24.45 

C24.5 

D35.11 

E38.2 

aluminium 
Other non-
ferrous 
metallurgy 
Casting of 
metals 
Coal fired 
power plants 
Waste 
incineration 
Soil remediation 
Road paving 

E39 
F42.11 
F42.12  Welding of 

G45.2 

N81.22 

O84.25 

railway sleepers 
Motor vehicles 
maintenance 
and repairs 
Chimney 
sweeps 
Firefighters 

 95,752  

 2,769  

 319,174  

 35  

30% 

 626  

 616  

 9  

 80  

 2,985  

 2,465  

 68,109  

 4,742  

 204,348  

 18,001  

 196  

 36,000  

 1,888  

 650  

 18,882  

 10,550  
 212,757  
 6,437  

 3,378  
 30,949  
 2,016  

 30,144  
 607,877  
 64,376  

 371,532  

 374,183  

 1,092,742  

 24,500  

 19,381  

 32,667  

 70  

 8  

 14  

 92  

 3  

 3  
 7  
 3  

 1  

 1  

21% 

25% 

33% 

50% 

10% 

35% 
35% 
10% 

34% 

75% 

438,506/ 
4,385,060 

 758  

 4,385,060  

 579/5785  

10/100% 

210 

 
 
 
 
Total 

Source: RPA (2024) 

1,284,052/5,
230,606 

441,066 

6,947,938 

2.9 

21%/ 
88% 

2.4.  Exposure concentrations by sectors 

Table 85 - summary of exposure concentrations (in ng/m3) by sectors, with adjustment for the use of RPE.  

Sector 

C10.13, C10.20  

Fish and meat smokehouses 

AM  Med
ian 
10  0.50 

P75  P90  P95  P10
0 

2.8 

13 

32  220 

C16.1 

C19.10 

C19.2 
C20.13 

C20.14 

C23.2 

C23.99a 

C23.99b 

C24.1 

C24.42 
C24.45 

C24.5 
D35.11 
E38.2 
E39.0 
F42.11 
F42.12 

G45.20 

N81.22 
O84.25 
Source: RPA (2024) 

Wood preservation (creosote) 

8.1 

8 

8.8 

9.5 

10 

11 

329 

216 

23 

15 
20.4  14.2
5 
152  57.5 

207 

38 

25 

20 

81 

36 

700 

405 

942  164
5 
130  320 
25.3  42.3  57.5  102.
5 
558  397.
5 
735  298
2 
130  280 

100 

350 

169 

346 

43 

86 

--  24.5 

270 

270 

270  825 

28 

12 

30 

63 

100  219 

--  13.2 
152  71.4 

99 
164 

99 
345 

50 
63 
14 
20 
0.6 
0.4 
76  42.5 
34  0.74 
270 

79 
25 
1.4 
88 
4.8 
440 

120 
41 
4.6 
169 
26 
690 

300-
400 
4.23  2.16  4.72  9.54  14.5 

99  500 
540  125
0 
150  240 
56  100 
9.2  33.8 
251  523 
70  460 
900  150
0 
31 

18 
29 

13 
25 

22 
35 

35 
48 

51 
58 

69 
83 

Coking plants 

Petroleum refineries 
Manufacture of carbon black 

Coal tar distillation 

Manufacture of refractory 
products 
Manufacture of bituminous 
products 
Graphite and carbon electrode 
production 
Steel and iron foundries, 
ferroalloys 
Manufacture of aluminium 
Other non-ferrous metallurgical 
processes 
Casting of metals 
Coal fired power plants 
Waste incineration  
Soil remediation 
Road paving  
Welding of train tracks 

Motor vehicle maintenance and 
repairs 
Chimney sweeps 
Firefighters 

211 

 
 
 
 
 
 
2.5.  Current risk management measures 

The following table presents the percentage breakdown of the primary RMMs used by enterprises 
in  each  sector.  This  is  based  upon  information  obtained  through  stakeholder  consultation  and 
literature review223.  

223 RPA (2024), op. cit. 

212 

 
 
 
 
 
Table 86 – Percentage breakdown of primary RMMs currently used by sector (row total = 100%)  

Sector 

Full  
enclosure 

Partial  
enclosure 

Open 
hood 

C10.13 & C10.2 
C16.1 
C19.1 
C19.2 
C20.13 
C20.14 
C23.2 
C23.99a 
C23.99b 
C24.1 
C24.42 
C24.45 
C24.5 
D35.11 
E38.2 
E39 
F42.11 
F42.12 
G45.2 
N81.22 
O84.25 
Source: RPA(2024), stakeholder survey 

5% 
40% 
- 
60% 
50% 
50% 
- 
- 
15% 
20% 
10% 
10% 
- 
40% 
50% 
- 
- 
- 
- 
5% 
- 

80% 
- 
40% 
- 
10% 
10% 
25% 
- 
15% 
10% 
15% 
15% 
- 
- 
- 
10% 
- 
- 
- 
10% 
- 

- 
- 
20% 
10% 
20% 
20% 
50% 
- 
15% 
- 
25% 
25% 
40% 
- 
- 
10% 
20% 
- 
- 
35% 
- 

Pressurised 
or sealed 
cabin 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
25% 
25% 
- 
- 
- 
10% 
- 
- 
- 
- 
- 

Simple 
enclosed 
cabin 
- 
- 
- 
- 
- 
- 
- 
- 
15% 
20% 
- 
- 
- 
- 
- 
10% 
20% 
- 
- 
10% 
- 

Breathing 
apparatus 

HEPA 
filter 

Simple 
mask 

Org. 
measures 

- 
- 
- 
- 
- 
- 
- 
- 
2% 
- 
- 
- 
- 
- 
10% 
10% 
- 
- 
- 
- 
- 

- 
40% 
20% 
- 
10% 
10% 
25% 
- 
18% 
- 
25% 
25% 
20% 
- 
10% 
10% 
- 
- 
- 
10% 
30% 

5% 
- 
- 
10% 
- 
- 
- 
- 
10% 
- 
- 
- 
- 
- 
10% 
10% 
- 
10% 
- 
10% 
- 

- 
- 
20% 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
10% 
10% 
- 
- 
- 
20% 

General 
dilution 
 ventilation 
10% 
10% 
- 
- 
10% 
10% 
- 
- 
10% 
50% 
- 
- 
40% 
20% 
20% 
10% 
- 
- 
- 
- 
- 

No  
ventilation 

- 
10% 
- 
20% 
- 
- 
- 
100% 
- 
- 
- 
- 
- 
40% 
- 
10% 
50% 
90% 
100% 
20% 
50% 

 
 
2.6.  Risk management measures required to achieve compliance 

The  table  below  outlines  the  number  of  processes  (by  sector)  that  are  currently  using  RMMs  and which  RMM  they  would  likely  change  to  meet  the 
require reduction of exposure for each policy option. 

Table 87: RMMs required to meet policy options (values = number of processes requiring RMM)  

RMMs 
require
d 

Sector 
(n) 

OEL: 
ng/m³ 
& 
BLV: 
nmol/
mol 
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C19.10 Manufacture of coke oven products (7) 

2 

7 

7 

7 

7 

2 

2 

5 

7 

7 

3 

4 

2 

5 

7 

2 

7 

7 

5 

5 

Current 

7 & 0.2 

70 & 0.3 

700  & 
1.5 
2000  & 
3.8 

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Never 

7 

5 

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7 

7 

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2 

2 

7 

7 

7 

7 

5 

5 

3 

1 

2 

C19.20 Manufacture of refined petroleum products (47)  

Current 

1 

4 

11 

45 

12 

12 

11 

16 

1 

7 

4 

4 

4 

4 

4 

4 

4 

4 

13 

16 

5 

4 

34 

3 

3 

7 

7 

3 

3 

4 

4 

4 

4 

45 

22 

23 

19 

23 

7 

1 

2 

12 

1 

4 

8 

6 

12 

5 

2 

2 

46 

43 

36 

2 

35 

47 

47 

35 

47 

36 

31 

46 

40 

47 

2 

47 

34 

31 

42 

44 

43 

44 

11 

40 

40 

47 

47 

47 

35 

42 

40 

46 

45 

47 

47 

34 

C20.13 Manufacture of other inorganic basic chemicals (16) 

Current 

7 & 0.2 

70 & 0.3 

700  & 
1.5 
2000  & 
3.8 
Never 

3 

1 

14 

14 

14 

4 

2 

2 

2 

2 

1 

2 

2 

2 

6 

12 

6 

2 

2 

9 

7 

6 

12 

2 

14 

12 

1 

3 

2 

1 

2 

3 

2 

2 

14 

2 

2 

2 

1 

1 

1 

2 

2 

2 

4 

1 

4 

1 

14 

7 

4 

1 

3 

2 

4 

2 

1 

5 

11 

11 

5 

16 

12 

2 

2 

2 

15 

12 

13 

16 

10 

4 

10 

3 

13 

3 

14 

2 

4 

13 

15 

14 

2 

14 

15 

14 

16 

14 

16 

10 

12 

2 

6 

9 

16 

14 

16 

C20.14 Manufacture of other organic basic chemicals (20) 

14 

14 

20 

20 

20 

6 

2 

16 

6 

10 

20 

2 

13 

2 

4 

3 

3 

1 

3 

1 

2 

2 

5 

20 

19 

5 

4 

3 

1 

2 

2 

4 

2 

8 

6 

6 

6 

6 

2 

6 

1 

12 

3 

10 

7 

1 

7 

3 

1 

13 

6 

4 

4 

7 

1 

1 

5 

4 

2 

1 

13 

19 

19 

20 

8 

17 

10 

13 

19 

13 

20 

7 

2 

8 

2 

7 

8 

8 

6 

6 

12 

15 

4 

14 

10 

18 

7 

18 

12 

15 

1 

11 

16 

20 

18 

11 

215 

7 & 0.2 

16 

70 & 0.3 

34 

36 

45 

700  & 
1.5 
2000  & 
3.8 
Never 

Current 

7 & 0.2 

70 & 0.3 

5 

11 

12 

700  & 
1.5 
2000  & 
3.8 
Never 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C22.19 Manufacture of other rubber products (1) 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

Current 

7 & 0.2 

70 & 0.3 

700  & 
1.5 
2000  & 
3.8 
Never 

Current 
7 & 0.2 

70 & 0.3 

700  & 
1.5 
2000  & 
3.8 
Never 

1 

2 

2 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

C24.42 Aluminium production (7) 

Current 

7 & 0.2 

70 & 0.3 

700  & 
1.5 
2000  & 
3.8 
Never 

2 

2 

2 

4 

2 

3 

7 

7 

7 

1 

1 

2 

4 

3 

2 

2 

2 

1 

1 

7 

4 

7 

3 

1 

6 

6 

5 

1 

3 

5 

4 

4 

3 

2 

1 

6 

3 

1 

2 

1 

1 

C24.5 Casting of metals (3) 

1 

3 

3 

3 

1 

1 

2 

1 

2 

2 

1 

1 

4 

7 

7 

4 

3 

3 

2 

5 

4 

4 

3 

2 

2 

4 

3 

3 

2 

2 

2 

1 

1 

2 

1 

2 

5 

7 

7 

6 

5 

7 

1 

2 

2 

1 
1 

1 

1 
1 

1 

1 

3 

4 

4 

3 

1 

2 

1 

1 

5 

3 

3 

2 

1 

2 

3 

3 

2 

1 

4 

7 

1 

4 

4 

3 

2 

1 

1 

1 

6 

2 

4 

4 

3 

1 

1 

2 

4 

4 

3 

2 

1 

5 

4 

4 

3 

2 

2 

1 

2 

1 

1 

6 

7 

1 

5 

1 

3 

2 

3 

2 

2 

3 

1 

2 

1 

3 

2 

3 

2 

1 

1 

1 

3 

2 

3 

3 

2 

3 

3 

3 

3 

2 

1 

2 

3 

3 

3 

3 

216 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
F42.11 Construction of roads and motorways (22) 

2 

6 

6 

Current 

7 & 0.2 

1 

70 & 0.3 

10 

9 

13 

700  & 
1.5 
2000  & 
3.8 
Never 

16 

19 

15 

6 

6 

19 

19 

6 

4 

2 

6 

4 

4 

6 

6 

6 

6 

4 

4 

6 

2 

2 

6 

6 

6 

3 

2 

4 

2 

2 

6 

2 

2 

2 

14 

17 

15 

17 

6 

6 

7 

2 

9 

16 

16 

2 

3 

16 

16 

18 

16 

22 

5 

18 

18 

16 

22 

G45.20 Maintenance and repair of motor vehicles (3) 

Current 

7 & 0.2 

70 & 0.3 

700  & 
1.5 
2000  & 
3.8 
Never 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

3 

Source: RPA (2024), stakeholder survey 

20 

13 

19 

19 

20 

19 

13 

14 

2 

19 

19 

18 

15 

19 

16 

2 

4 

2 

2 

2 

2 

22 

2 

20 

3 

3 

1 

1 

1 

1 

3 

1 

1 

1 

1 

1 

3 

3 

3 

3 

3 

2 

6 

4 

4 

2 

3 

3 

3 

3 

3 

2 

2 

2 

6 

4 

6 

2 

2 

2 

2 

6 

6 

22 

20 

16 

16 

20 

20 

20 

3 

3 

3 

3 

3 

3 

4 

2 

5 

2 

2 

2 

2 

2 

2 

2 

2 

20 

17 

20 

18 

3 

3 

3 

3 

3 

3 

3 

6 

2 

2 

3 

4 

5 

2 

3 

3 

3 

3 

3 

3 

6 

6 

6 

3 

3 

3 

3 

3 

3 

6 

6 

7 

2 

3 

3 

3 

3 

3 

217 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.7.  National limit value(s) 

Country 

EU countries 
Austria 1,2,3 

Belgium 1,4 

0.002 

- 

Bulgaria 5 

0.00015 ** 

Croatia 6 

- 

Cyprus 7 
Czechia 8 
Denmark 1,2,9 

- 
0.005 * 
0.2 1,2  ** 

- 9 

Estonia 10 

0.002 * 

Table 88 - current OELs and STELs in EU Member States and selected non-EU countries 
OEL 
[mg/m3] 

Specification 
of OEL 

STEL 
[mg/m3] 

- B[a]P, TRK value#, Carc, Sd, Sk 

0.008 

- PAHs mixtures, particularly those 
containing B[a]P, which are 
carcinogens within the meaning of 
2004/37 Directive Carc, Sk  
- B[a]P 

- PAHs mixtures, particularly those 
containing B[a]P, which are 
carcinogens within the meaning of 
2004/37 Directive, Sk  
- PAHs mixtures, particularly those 
containing B[a]P, which are 
carcinogens within the meaning of 
2004/37 Directive, Sk  

- 

- 

- 

- B[a]P, Carc, Repro, S, Sk  
- PAHs - benzene soluble, Carc, Sk 
1,2 

- 
0.025 * 
0.4 1,2 

- PAHs mixtures, particularly those 
containing B[a]P, Sk 9 
- B[a]P, Carc, Repro, Sk 

0.02 * 

Specification of STEL 

- B[a]P, TRK value#, Carc, 
Sd, Sk 

- B[a]P, Carc, Repro, S, Sk  
- PAHs - benzene soluble, 15 
min average value, Carc, Sk 
1,2 

- B[a]P, Carc, Repro, Sk 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
- 

- PAHs mixtures, particularly those 
containing B[a]P, Carc, Sk 

Finland 1,2,11 

0.01 ^^ 

- B[a]P, Sk 

France 1,12 

Germany 1,2,13 

Greece 14 
Hungary 1,2,15 
Ireland 16 

- 
- 

0.0007 (I) § * 
0.00007 (I) $ 

0.005 * 
0.002 * 
- 

Italy 1,17 

- 

Latvia 1,2,18 
Lithuania 19 

Luxembourg 20 
Malta 21 
Netherlands 1,2,22 

0.00015 ** 
0.002 * 

- 
- 
0.00055 ** 

Poland 1,2,23 

0.002 ** 

- PAHs mixtures, Sk 
- PAHs mixtures, particularly those 
containing B[a]P, Carc, Sk 
- B[a]P as key component in 
defined PAH-mixtures, Sk 

- B[a]P  
- B[a]P, Carc 
- PAHs mixtures, particularly those 
containing B[a]P, Carc, Sk 
- PAHs mixtures, particularly those 
containing B[a]P, which are 
carcinogens within the meaning of 
2004/37 Directive, Sk  
- B[a]P* + 
- B[a]P ##, Carc, S, Repro, Sk 

- B[a]P, same value also applies for 
PAHs derived from coal (as B[a]P), 
Sk 
- B[a]P, Sk 

219 

- 

- 

0.0056 (I) § * 

- 
- 
- 

- 

- 
0.02 * 

- 
- 
- 

- 

- B[a]P as key component in 
defined PAH-mixtures, 15 
min average value, Sk 

- B[a]P ##, 15 min average 
value, Carc, Repro, S, Sk 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Portugal 24 
Romania 1,2,25 

0.002 ** 

- 
0.2 1,2* 

- 25 

- For 9 carcinogenic PAHs**++23, 
same value applies for PAHs-
benzene soluble 1,2, Sk 

- PAHs - benzene soluble 1,2 

- PAHs mixtures, particularly those 
containing B[a]P, Carc 25 

- 
- 

Slovakia 27 

0.002 ** 

- Ba[a]P, TRK value#, Carc, Sk & 

0.008 ** 

- 

Slovenia 27 

0.002 ** 

Spain 28 

0.2* 

Sweden 1,2,29 

0.002 ** 

European Union 30 
RAC 2 
Candidate countries 
Albania 46 
Bosnia and 
Herzegovina 47 

- 
- 

- 
- 

- PAHs mixtures, particularly those 
containing B[a]P, which are 
carcinogens, Sk 
- Ba[a]P, TRK value#, Carc, Repro 
& 
- Coal tar, benzene soluble, Carc, 
Repro & 
- B[a]P, Carc, Repro, Sk 

0.008 ** 

- 

0.02 ^^ 

- IOELV, Sk 
- Sk 

- 
- 

- 
- 

220 

- Ba[a]P, TRK value#, Carc, 
Sk & 

- Ba[a]P, TRK value#, Carc, 
Repro & 

- B[a]P, 15 min maximum 
value, Carc, Repro, Sk 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Georgia 48 
Moldova 49 
Montenegro 50 

- 
0.00015 * 

North Macedonia 51 
Serbia 52 
Turkey 41 
Ukraine 53 
Other countries 
Australia 31 
Brazil 32 
Canada, Ontario 1,33 
Canada, Québec 1,34 

China 
India 35 
Japan, MHLW 36 
Japan, JOSH 37 
Norway 1,2,38 

0.002 * 
- 
- 
- 

- 
- 
- 
0.005 *** 

0.2 *** 

- 
- 
0.2 *** 
- 
0.04 ^^ 

Russia 39 

- 

- B[a]P, Carc 
- Mixtures of polycyclic aromatic 
hydrocarbons, especially those 
containing benzo(a)pyrene, which 
are carcinogenic, Carc, Sk 
- B[a]P, B[d,e,f,]P, Carc, Repro, Sk 

- B[a]P, Carc 

- particulate PAHs - benzene 
soluble, Carc 

- Coal tar, benzene soluble 
- Carc 
- For sum of 21 PAHs***+++ 
collected as particulates 38, same 
value applies for PAHs-benzene 
soluble 1,2, Carc, Sk 

221 

- 
- 
- 

- 
- 
- 
- 

- 
- 
- 
- 

- 
- 
- 
- 
- 

- 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
South Korea 1 
Switzerland 1,2,40 

United Kingdom 42 
USA, ACGIH 43 
USA, NIOSH 44,$$ 

USA, OSHA 1,45 
Source: RPA (2024) 

0.2 % 
0.002 * 

0.2 (I) * 
- 
0.2 ^ 
0.1 ^ 

0.2 * 

- PAHs - benzene soluble 
- B[a]P, Carc, Repro, Sk 

- PAHs from coal tar pitch, Carc 

- PAHs - benzene soluble, Carc 
- PAHs from coal tar pitch - 
cyclohexane soluble, Carc 
- PAHs - benzene soluble %, Carc 

- 
- 

- 
- 
- 

- 

Notes: 
RAC = Committee for Risk Assessment 
MHLW = Ministry of Health, Labour and Welfare 
JSOH = Japan Society for Occupational Health 
ACGIH = American Conference of Governmental Industrial Hygienists 
NIOSH = National Institute for Occupational Safety and Health 
OSHA = Occupational Safety and Health Administration 
(I) = inhalable fraction/aerosol 
* Binding value according to country-specific source 
** Binding value according to reply of member state authority on questionnaire 
*** Binding value according to the Final report for OEL/STEL deriving systems from 2018 (Available at: https://bit.ly/3PKDhbS, accessed on 05.07.2023). Status was not checked since 2018. 
^ Indicative value according to country-specific source 
^^ Indicative value according to reply of member state authority on questionnaire 
^^^ Indicative value according to the Final report for OEL/STEL deriving systems from 2018 (Available at: https://bit.ly/3PKDhbS, accessed on 05.07.2023). Status was not checked since 2018. 
% According to (country-specific source) unclear if value is binding or indicative 
& Information according to reply of member state authority on questionnaire 
Carc = notation for carcinogenicity 
Repro = notation for reproductive toxicity  
Sk = skin notation assigned or danger of skin absorption 
S = notation for sensitisation assigned.  Where a more detailed notation for sensitisation was given, the following notations were reported: 
Sd = skin/dermal sensitisation 
- no value available  
# TRK value (“Technische Richtkonzentration”, Technical Guidance Concentration), based on technical feasibility  
## B[a]P can be present together with other polycyclic aromatic hydrocarbons in smoke, dust or mist, such as from bitumen and asphalt, and in some oils and combustion products 
§ Workplace exposure concentration corresponding to the proposed tolerable cancer risk  

222 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ Workplace exposure concentration corresponding to the proposed preliminary acceptable cancer risk 
$$ For NIOSH recommended exposure limits (RELs), "TWA" indicates a time-weighted average concentration for up to a 10-hour workday during a 40-hour workweek.“; Online: https://www.cdc.gov/niosh/npg/pgintrod.html, 
accessed December 2022 
*+ Additional OELs are derived for coal tar and pitch sublimates with an average content of benzo[a]pyrene (CAS No. 50-32-8): less than 0.075% an OEL of 0.2 mg/m³; 0.075-0.15 % an OEL of 0.1 mg/m³, and 0.15-0.3% an OEL 
of 0.05 mg/m³. 
**++ The nine PAHs are dibenzo[a,h]anthracene, benzo[a]pyrene, benzo[a]anthracene, benzo[b]fluoroanthene, benzo[k]fluoroanthene, indeno[1,2,3-c,d]pyrene, anthracene, benzo[g,h,i]perylene, and chrysene 
***+++ Sum of the following 21 PAH compounds: Anthracene, benz[a]anthracene), benzo[a]fluorene, benzo[b]fluorene, benzo[b]fluoranthene, benzo[j]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, benzo[e]pyrene, 
benzo[ghi]perylene, dibenzo[a,h])anthracene, dibenzo[a,e]pyrene, dibenzo[a,h]pyrene, dibenzo[a,i]pyrene, dibenzo[a,l]pyrene, phenanthrene, fluoranthene, indenol((1,2,3-cd)pyrene, chrysene, pyrene, and triphenylene. 
$$ OSHA defines “coal tar pitch volatiles” as the fused polycyclic hydrocarbons that volatilize from the distillation residues of coal, petroleum (excluding asphalt), wood, and other organic matter and includes substances such as 
anthracene, benzo(a)pyrene (BaP), phenanthrene, acridine, chrysene, pyrene, etc 

Sources: 
1: Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) GESTIS– International Limit Values. Available at: http://limitvalue.ifa.dguv.de/, accessed on 02.12.2022 
2: RAC, Committee for Risk Assessment (2022) ANNEX 1 in support of the Committee for Risk Assessment (RAC) for evaluation of limit values for polycyclic aromatic hydrocarbons at the workplace. European Chemicals Agency 
(ECHA), Helsinki, Finland. Available at: https://echa.europa.eu/documents/10162/7937606/annex1_rac_opi_oel_pah_en.pdf/8222f456-ee7f-bf3b-66b2-aebf39693bb9?t=1675065114197, accessed on 05.01.2023 
3: Austria (2021) Grenzwerteverordnung 2021 – GKV. Available at: https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20001418, accessed on 02.12.2022 
4: Belgium (2021) List of limit values (Titel 1. – Chemische agentia. and Titel 2. – Kankerverwekkende, mutagene en reprotoxische agentia). Available at: https://werk.belgie.be/nl/themas/welzijn-op-het-werk/algemene-
beginselen/codex-over-het-welzijn-op-het-werk, accessed on 02.12.2022 
5: Bulgaria (2021) List of limit values and list of carcinogenic/mutagenic/reprotoxic substances. Available at: https://www.lex.bg/laws/ldoc/2135477597 and https://www.lex.bg/bg/mobile/ldoc/2135473243, accessed on 
05.12.2022 
6: Croatia (2021) List of limit values. Available at: https://narodne-novine.nn.hr/clanci/sluzbeni/2021_01_1_10.html, accessed on 05.12.2022 
7: Cyprus (2021) Legislation on chemical agents and legislation on carcinogenic-mutagenic agents. Available at: https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/E3237CC15BD91575C2257E030029E9FF?OpenDocument and 
https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/D74ACEE6A814B7EAC2257E03002A76C9?OpenDocument, accessed on 05.12.2022 
8: Czechia (2022) List of limit values. Available at: https://www.tzb-info.cz/pravni-predpisy/narizeni-vlady-c-361-2007-sb-kterym-se-stanovi-podminky-ochrany-zdravi-pri-praci, accessed on 05.12.2022 
9: Denmark (2022) List of limit values. Available at: https://www.retsinformation.dk/eli/lta/2022/1054, accessed on 05.12.2022 
10: Estonia (2022) List of limit values. Available at: https://www.riigiteataja.ee/aktilisa/1120/3202/2025/VV_30m_lisa.pdf#, accessed on 05.12.2022 
11: Finland (2020) List of limit values. Available at: https://julkaisut.valtioneuvosto.fi/handle/10024/162457, accessed on 05.12.2022 
12: France (2022) List of limit values. Available at: https://www.inrs.fr/media.html?refINRS=outil65, accessed on 05.12.2022 
13: Germany (2022) List of limit values for carcinogenic hazardous substances (TRGS 910). Available at: https://www.baua.de/EN/Service/Legislative-texts-and-technical-rules/Rules/TRGS/TRGS-910.html, accessed on 
05.12.2022 
14: Greece (2019) List of limit values. Available at: https://www.elinyae.gr/sites/default/files/2019-10/oriakes%20times%202019_L_0.pdf, accessed on 05.12.2022 
15: Hungary (2022) List of limit values. Available at: https://net.jogtar.hu/jogszabaly?docid=a2000005.itm, accessed on 05.12.2022 
16: Ireland (2021) List of limit values. Available at: https://www.hsa.ie/eng/publications_and_forms/publications/chemical_and_hazardous_substances/2021-code-of-practice-for-the-chemical-agents-and-carcinogens-
regulations.pdf, accessed on 05.12.2022 
17: Italy (2022) List of limit values and amendments. Available at: https://www.ispettorato.gov.it/it-it/strumenti-e-servizi/Documents/TU-81-08-Ed.-Agosto-2022.pdf, accessed on 06.12.2022 
18: Latvia (2022) List of limit values. Available at: https://likumi.lv/doc.php?id=157382&from=off, accessed on 06.12.2022 
19: Lithuania (2022) List of limit values. Available at: https://www.e-tar.lt/portal/lt/legalAct/TAR.8012ED3EA143/asr, accessed on 06.12.2022 
20: Luxembourg (2020) List of limit values (2018) and list of carcinogens and mutagens (2020). Available at: http://legilux.public.lu/eli/etat/leg/rgd/2018/07/20/a684/jo and 
http://legilux.public.lu/eli/etat/leg/rgd/2020/01/24/a37/jo, accessed on 06.12.2022 
21: Malta (2021) List of limit values. Available at: https://legislation.mt/eli/sl/424.24/eng/pdf, accessed on 06.12.2022 

223 

 
 
 
 
 
22: Netherlands (2022) List of limit values. Available at: https://wetten.overheid.nl/BWBR0008587/2022-07-01#BijlageXIII, accessed on 06.12.2022 
23: Poland (2021) List of limit values from 2018 and amendments in 2020 and 2021. Available at: https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20180001286/O/D20181286.pdf, 
http://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20200000061, and https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20210000325/O/D20210325.pdf, accessed on 06.12.2022 
24: Portugal (2022) List of limit values. Available at: https://dre.pt/dre/legislacao-consolidada/decreto-lei/2012-115495237, accessed on 07.12.2022 
25: Romania (2021) List of limit values. Available at: https://legislatie.just.ro/Public/DetaliiDocument/75978, accessed on 07.12.2022 
26: Slovakia (2020) List of limit values. Available at: https://www.epi.sk/zz/2006-355, accessed on 07.12.2022 and https://www.slov-lex.sk/pravne-predpisy/prilohy/SK/ZZ/2006/356/20201001_5255550-2.pdf, accessed on 
05.07.2023  
27: Slovenia (2021) List of limit values. Available at: http://www.pisrs.si/Pis.web/pregledPredpisa?id=PRAV14252, accessed on 07.12.2022 and https://www.uradni-list.si/files/RS_-2007-053-02834-OB~P001-0000.PDF, 
accessed on 05.07.2023 
28: Spain (2022) List of limit values. Available at: https://www.insst.es/el-instituto-al-dia/limites-de-exposicion-profesional-para-agentes-quimicos-2022, accessed on 07.12.2022 
29: Sweden (2022) List of limit values and amendments. Available at: https://www.av.se/arbetsmiljoarbete-och-inspektioner/publikationer/foreskrifter/hygieniska-gransvarden-afs-20181-foreskrifter/, accessed on 07.12.2022 
30: European Union, Directive 2019/130 of the European Parliament and of the council of 16 January 2019 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or 
mutagens at work (second amendment). Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32019L0130&from=EN, accessed on 07.12.2022 
31: Australia (2022) List of limit values. Available at: https://www.safeworkaustralia.gov.au/doc/workplace-exposure-standards-airborne-contaminants-2022, accessed on 07.12.2022 
32: Brazil (2021) List of limit values. Available at: https://www.guiatrabalhista.com.br/legislacao/nr/nr-15-anexo-11.pdf, accessed on 07.12.2022 
33: Canada, Ontario (2020) List of limit values. Available at: https://www.ontario.ca/laws/regulation/900833, accessed on 07.12.2022 
34: Canada, Québec (2022) List of limit values. Available at: https://www.legisquebec.gouv.qc.ca/en/document/cr/S-2.1,%20r.%2013, accessed on 07.12.2022 
35: India (2007) List of limit values. Available at: https://dgfasli.gov.in/en/book-page/permissible-levels-certain-chemical-substancesin-work-environment, accessed on 08.12.2022 
36: Japan (2022) List of limit values. Available at: https://www.nite.go.jp/en/chem/chrip/chrip_search/intSrhSpcLst?slIdxNm=&slScNm=RJ_04_061&slScCtNm=&slScRgNm=&ltCatFl=&slMdDplt=0&ltPgCt=200&stMd, 
accessed on 12.12.2022 
37: Japan - JOSH (2022) List of limit values. Available at: https://www.sanei.or.jp/english/files/topics/oels/oel_en.pdf, accessed on 08.12.2022 
38: Norway (2022) List of limit values. Available at: https://lovdata.no/dokument/SF/forskrift/2011-12-06-1358#KAPITTEL_8, accessed on 10.12.2022 
39: Russia (2021) List of limit values. Available at: http://publication.pravo.gov.ru/Document/View/0001202102030022, accessed on 10.12.2022 
40: Switzerland (2022) List of limit values. Available at: https://www.suva.ch/de-ch/services/grenzwerte#gnw-location=%2F, accessed on 10.12.2022 
41: Turkey (2013) List of limit values. Available at: https://www.resmigazete.gov.tr/eskiler/2013/08/20130812-1.htm, accessed on 10.12.2022 
42: United Kingdom (2020) List of limit values. Available at: https://www.hse.gov.uk/pubns/priced/eh40.pdf, accessed on 10.12.2022 
43: ACGIH, American Conference of Governmental Industrial Hygienists (2022), TLVs and BEIs Based on the Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure 
Indices. 
44: USA, NIOSH (2022) List of limit values. Available at: https://www.cdc.gov/niosh/index.htm, accessed on 10.12.2022 
45: USA, OSHA (2022) List of limit values. Available at: https://www.osha.gov/dsg/annotated-pels/tablez-1.html, accessed on 10.12.2022 
46: Albania (2014) Albania (2014) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/115604/ALB-115604.pdf; accessed on 26.03.2024 
47: Bosnia and Herzegovina (2020) Law on protection at work - part one. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/112339/BIH-112339.pdf; accessed on 26.03.2024 
48: Georgia (2014) List of permissible concentrations of metals in the air of the working area. Available at: https://matsne.gov.ge/ka/document/view/2198163?publication=0, accessed on 28.03.2024 
49: Moldova (2013) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/97247/PDF.pdf, accessed on 26.03.2024 
50: Montenegro (2023) List of carcinogens and mutagens. Available at:  and https://www.gov.me/dokumenta/d41be940-6c22-499d-8c32-3619e0a6d332, accessed on 27.03.2024 
51: North Macedonia (2010) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/94988/MKD-94988.pdf, accessed on 27.03.2024 
52: Serbia (2018) List of limit values. Available at: http://www.socijalnoekonomskisavet.rs/cir/publikacije/propisi%20bzr.pdf, accessed on 28.03.2024 
53:  Ukraine (2020) List of limit values and amendments (2023). Available at: https://zakon.rada.gov.ua/laws/show/z0741-20#Text, accessed on 28.03.2024 

224 

 
 
 
 
 
3.  1,4-DIOXANE 

3.1.  Relevant sectors with exposed workers 

Table 89 - relevant sectors with risk of exposure to 1,4-dioxane 
NACE full name 
Short name for sector 

NACE 
code 

N/A 

Manufacture of 1,4-dioxane 

C21.1  and 
C21.2 
C20.1, 
C20.3  and 
C20.5 

M72.1 

C20.4  excl. 
C20.42 

C20.42 

production 

Pharmaceutical 
(intentional use) 
Industrial  use  as  a  solvent 
and  generation  as  a  by-
product 
the  chemicals 
sector 

in 

Laboratories  (intentional  use 
as a solvent) 
Surfactants  –  presence  as  a 
minor constituent/impurity in 
the  production  of  detergents, 
soaps, etc. 
Cosmetics  –  generation  as  a 
by-product  in  the  production 
of cosmetics 

Part  of  C20.1  Manufacture  of  basic  chemicals, 
fertilisers  and  nitrogen  compounds,  plastics  and 
synthetic rubber in primary forms 
C21.1 Manufacture of basic pharmaceutical products 
C21.2 Manufacture of pharmaceutical preparations 
C20.1Manufacture of basic chemicals, fertilisers and 
nitrogen compounds, plastics and synthetic rubber in 
primary forms 
C20.3  Manufacture  of  paints,  varnishes  and  similar 
coatings, printing ink and mastics 
C20.5 Manufacture of other chemical products 
M72.1  Research  and  experimental  development  on 
natural sciences and engineering 
C20.4  Manufacture  of  soap  and  detergents,  cleaning 
and  polishing  preparations,  perfumes  and  toilet 
preparations,  excluding  C20.42  Manufacture  of 
perfumes and toilet preparations 
C20.42  Manufacture  of  perfumes  and 
preparations 

toilet 

Source: RPA (2024) 

225 

 
 
 
 
3.2.  Estimated number of enterprises with exposed workers in the EU 

Table 90 – estimated number of EU enterprises with exposed workers by sector and by size of enterprise  

Sector 

Number of enterprises 

Part of C20.1 
C21.1 and C21.2 

C20.1, C20.3 and 
C20.5 

M72.1 
C20.4 excl. C20.42 

C20.42 

Source: RPA (2024) 

Manufacture of 1,4-dioxane 
Pharmaceutical production (intentional 
use) 
Industrial use as a solvent and 
generation as by-product in the 
chemicals sector 
Laboratories 
Surfactants – generation as a by-
product in the production of 
detergents, soaps, etc. 
Cosmetics – generation as a by-
product in the production of cosmetics 

Total 

2 
95 

105 

1,480 
53 

70 

Small      <50 
employees 
0 
71 

Medium    50-249 
employees 
0 
13 

Large    >249 
employees 
2 
11 

11 

32 
3 

4 

4 

7 
1 

1 

90 

1,441 
49 

65 

226 

 
 
 
 
 
 
 
 
3.3.  Estimated number of exposed workers in the EU 

Table 91 – estimated number of workers in the EU exposed to 1,4-dioxane  

Sector 

Number of exposed workers  Total number of workers in 

N/A (part of C20.1) 
C21.1 and C21.2 
C20.1, C20.3 and 
C20.5 
M72.1 
C20.4 excl. C20.42 

C20.42 

Total 
Source: RPA (2024) 

Manufacture of 1,4-dioxane 
Pharmaceutical production (intentional use) 
Industrial use as a solvent and generation as 
by-product in the chemicals sector 
Laboratories 
Surfactants – presence as a minor 
constituent/impurity in the production of 
detergents, soaps, etc. 
Cosmetics – generation as a by-product in 
the production of cosmetics 

3.4.  Exposure concentrations by sectors 

150 
15,000 
5,450 

7,400 
1,150 

2,000 

31,150 

NACE code 
548,777 
637,569 
869,517 

505,291 
92,680 

198,169 

2,852,003 

% of all workers in NACE 
code 
0.03% 
2% 
0.6% 

1% 
1% 

1% 

1% 

Sector 

AM 

Median 

P75 

P90 

P95 

Max 

Table 92 - summary of exposure concentrations (in mg/m3) by sectors.   

Part of 
C20.1 

Manufacture of 1,4-dioxane 

C21.1 and 
C21.2 

Pharmaceutical production 
(intentional use) 

6.5 

Significantly <7.3 

<3.6 
18  

227 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C20.1, C20.3 
and C20.5 

Industrial use as a solvent and 
generation as by-product in the 
chemicals sector 

M72.1 

Laboratories 

C20.4 excl. 
C20.42 

Surfactants - presence as a minor 
constituent/impurity in the 
production of detergents, soaps, 
etc. 

C20.42 

Cosmetics – generation as a by-
product in the production of 
cosmetics 

Source: RPA (2024) 

40 

5 
0.11 
<0.07 
3.6 

228 

180 (but not 100% of 
the time) so 90 taken 
forward 

<3.2 
<2.9 
<18 
<0.008 
6.5 
25 
166 
0.18 

<3.6 
32 (but only if not 
ventilated) 

7.3 

0.58 
0.15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.5.  Current risk management measures 

Measure 

Table 93 –  Companies’ use of RMMs for individual process  

% of respondents that use the measure for at least one process with 
worker exposure to 1,4-dioxane 

Reducing the amount of substance used 
Reducing the number of workers exposed 
Rotating the workers exposed 
Redesign of work processes 
Closed systems 
Partial hood enclosures 
Open hoods over equipment or local extraction ventilation 
General ventilation 
Pressurised or sealed control cabs 
Simple enclosed control cabs 
Self-contained breathing apparatus (with bottled air) or airline respirators (air 
supplied by hose) 
Powered air-purifying respirators 
Half and full facemasks (negative pressure respirators) 
Disposable respirators (FFP masks) 
Face screens, face shields, visors 
Goggles 
Gloves 
Continuous measurement to detect unusual exposures 
Training and education 
Cleaning 
Measures for workers’ personal hygiene (e.g. daily cleaning of work clothing, 
obligatory shower) 

229 

20% 
0% 
20% 
0% 
100% 
0% 
60% 
80% 
20% 
20% 
0% 

0% 
20% 
0% 
20% 
60% 
80% 
20% 
60% 
20% 
20% 

 
 
 
 
Provision of separate storage facilities for work clothes 
Formal/external RPE cleaning and filter changing regime 
Continuous measurement of air concentrations to detect unusual exposures 
Creating a culture of safety 
Partial substitution of 1,4-dioxane used in this activity in the past 
Discontinuation of part of the activity using 1,4-dioxane 
PPE is essential regardless of the OEL 
Source: RPA (2024), stakeholder survey 

20% 
0% 
0% 
60% 
0% 
0% 
80% 

3.6.  Risk management measures required to achieve compliance 

Table 94: RMMs required to meet policy options, % of processes (in brackets: number of processes) 

Measure 
No action required as OEL already achieved 
Organisational and hygiene measures: Cleaning 
Organisational and hygiene measures: Continuous 
measurement of air concentrations to detect unusual 
exposures 
Organisational and hygiene measures: Continuous 
measurement to detect unusual exposures 
Organisational and hygiene measures: Creating a culture 
of safety 
Organisational and hygiene measures: Formal/external 
RPE cleaning and filter changing regime 
Organisational and hygiene measures: Measures for 
workers’ personal hygiene (e.g. daily cleaning of work 
clothing, obligatory shower) 

Currently in place 

73 mg/m3  
58% (7) 

36 mg/m3  
58% (7) 

20 mg/m3 
50% (6) 

7.3 mg/m3  
33% (4) 

25% (3) 

8% (1) 

67% (8) 

25% (3) 

230 

17% (2) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Organisational and hygiene measures: Provision of 
separate storage facilities for work clothes 
Organisational and hygiene measures: Training and 
education 
Other 
PPE (Personal Protective Equipment): Disposable 
respirators (FFP masks) 
PPE (Personal Protective Equipment): Face screens, face 
shields, visors 
PPE (Personal Protective Equipment): Gloves 
PPE (Personal Protective Equipment): Goggles 
PPE (Personal Protective Equipment): Half and full 
facemasks (negative pressure respirators) 
PPE (Personal Protective Equipment): Powered air-
purifying respirators 
PPE (Personal Protective Equipment): PPE is essential 
regardless of the OEL 
PPE (Personal Protective Equipment): Self-contained 
breathing apparatus (with bottled air) or airline 
respirators (air supplied by hose) 
Restructuring operations/processes: Redesign of work 
processes 
Restructuring operations/processes: Reducing the amount 
of substance used 
Restructuring operations/processes: Reducing the 
number of workers exposed 
Restructuring operations/processes: Rotating the workers 
exposed 

25% (3) 

67% (8) 

17% (2) 

8% (1) 

92% (11) 
75% (9) 
8% (1) 

92% (11) 

8% (1) 

25% (3) 

25% (3) 

25% (3) 

25% (3) 

42% (5) 

25% (3) 
25% (3) 

8% (1) 

8% (1) 

17% (2) 

8% (1) 

8% (1) 

8% (1) 

8% (1) 

8% (1) 

8% (1) 

8% (1) 

8% (1) 

231 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Substitution or discontinuation: Discontinuation of part 
of the activity using 1,4-dioxane 
Substitution or discontinuation: Discontinuation of 
process using the substance 
Substitution or discontinuation: Partial substitution of 
1,4-dioxane used in this activity in the past 
Substitution or discontinuation: Substitution of substance 
Ventilation and extraction: Closed systems 
Ventilation and extraction: General ventilation 
Ventilation and extraction: Open hoods over equipment 
or local extraction ventilation 
Ventilation and extraction: Partial hood enclosures 
Ventilation and extraction: Pressurised or sealed control 
cabs 
Ventilation and extraction: Simple enclosed control cabs 
Source: RPA (2024), stakeholder survey 

3.7.  National limit value(s) 

67% (8) 
58% (7) 
33% (4) 

8% (1) 

8% (1) 

17% (2) 
8% (1) 

17% (2) 
8% (1) 

8% (1) 
17% (2) 
8% (1) 

17% (2) 

25% (3) 
17% (2) 
17% (2) 

Country 

Austria 1,2,3 
Belgium 1,2,4 
Bulgaria 5 
Croatia 6 
Cyprus 7 
Czechia 8 

Table 95 - current OELs and STELs in EU Member States and selected non-EU countries 
Specification of OEL 

STEL (mg/m³) 

OEL (mg/m³) 

73 * 
73 ** 
73 ** 
73 ** 
73 ** 
70 * 

- Carc, Sk 
- Sk 

- Sk 

232 

146 * 
- 
20 ** 
- 
- 
140 * 

Specification of STEL 

- Momentary value, Carc, Sk 

- Sk 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Denmark 1,2,9 

Estonia 10 
Finland 1,2,11 
France 1,2,12 

Germany 1,2,13 
Greece 14 
Hungary 1,15 
Ireland 1,2,16 
Italy 1,17 
Latvia 1,2,18 
Lithuania 19 
Luxembourg 20 
Malta 21 
Netherlands 1,22 
Poland 1,2,23 
Portugal 24 
Romania 1,2,25 
Slovakia 27 
Slovenia 27 
Spain 1,2,28 
Sweden 1,2,29 
European Union 1,2,30 
RAC 2 
EU candidate counties 
Albania 46 
Bosnia and Herzegovina 47 

36 (T) & ** 

73 * 
36 (I) & ^^ 
73 * 

73 * 
73 * 
73 * 
73 ^^ 
73 ** 
20 ** 
35 ** 
73 *** 
73 % 
20 (T) & ** 
50 (V) &  ** 
73 ^ 
73 * 
73 ** 
73 ** 
73 ** 
35 ** 
73 
7.3 

73 ^ 
- 

- Carc, Sk 

- Sk 
-  Restrictive  statutory 
values, Carc 
- Sk  

limit 

- Sk 
- Sk 
- Sk 

- Carc 

- Carc, Sk 

- Sk 
- Carc, Sk 
- Carc 
- IOELV 
- Sk 

- Sk 

233 

72 (T) & ** 

- 
150 (I) & ^^ 
140 ^ 

146 * 
- 
- 
- 
- 
- 
90 ** 
- 
- 
- 
- 
- 
- 
- 
146 ** 
- 
90 ^^ 
- 
73 

20 ^ 
- 

-  15  min  average  value,  Carc, 
Sk 

- 15 min average value, Sk 
- Carc 

- 15 min average value, Sk 

- Carc 

- Sk 

- 15 min average value, Carc 

- Sk 

- Sk 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Georgia 48 
Moldova 49 
Montenegro 50 
North Macedonia 51 
Serbia 52 
Turkey 1,41 
Ukraine 53 
Other countries 
Australia 1,31 
Brazil 32 
Canada, Ontario 1,33 
Canada, Québec 1,34 
China  
India 35 
Japan, MHLW 1,36 
Japan, JOSH 1,37 
Norway 1,2,38 
Russia 39 
South Korea 1 
Switzerland 1,2,40 
United Kingdom 1,2,42 
USA, ACGIH 43 

USA, NIOSH 1,2,44 

USA, OSHA 1,2,45 
Source: RPA (2024) 

Notes: 

- 
73 * 
- 
73 * 
73 * 
73 % 
- 

36 *** 
- 
20 *** 
72 *** 
- 
- 
10 *** 
3.6 ^^^ 
18 (T) & ^^ 
10 (V) % 
20 % 
72 * 
73 * 
20 ^ 

- 

360 * 

- 
10 * 
- 
- 
- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
36 (T) & ^^ 
- 
- 
144 * 
- 
- 

3.6 

- 

- Carc, Sk 

- Carc, Sk 

- value only given in ppm 
- Carc, Sk 

- value only given in ppm 
- Carc, Sk 
- Carc, Sk 

- value only given in ppm, Sk 
- Carc, Sk 
- Sk 
-  value  only  given  in  ppm, 
Carc, Sk 

- Sk 

234 

- 15 min average value, Sk 

- Carc, Sk 

-  ceiling  limit  value  (30  min), 
Carc 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RAC = Committee for Risk Assessment 
MHLW = Ministry of Health, Labour and Welfare 
JSOH = Japan Society for Occupational Health 
ACGIH = American Conference of Governmental Industrial Hygienists 
NIOSH = National Institute for Occupational Safety and Health 
OSHA = Occupational Safety and Health Administration 
(V) = vapour 
* Binding value according to country-specific source 
** Binding value according to reply of member state authority on questionnaire 
*** Binding value according to the Final report for OEL/STEL deriving systems from 2018 (Available at: https://bit.ly/3PKDhbS, accessed on 05.07.2023). Status was not checked since 2018. 
^ Indicative value according to country-specific source 
^^ Indicative value according to reply of member state authority on questionnaire 
^^^ Indicative value according to the Final report for OEL/STEL deriving systems from 2018 (Available at: https://bit.ly/3PKDhbS, accessed on 05.07.2023). Status was not checked since 2018. 
% According to (country-specific source) unclear if value is binding or indicative 
& Information according to reply of member state authority on questionnaire 
Carc = notation for carcinogenicity   
Sk = skin notation assigned or danger of skin absorption 
- no value available  

Sources: 
1: Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) GESTIS– International Limit Values. Available at: http://limitvalue.ifa.dguv.de/, accessed on 02.12.2022 
2: RAC, Committee for Risk Assessment (2022) ANNEX 1 in support of the Committee for Risk Assessment (RAC) for evaluation of limit values for 1,4-dioxane at the workplace. European Chemicals Agency (ECHA), Helsinki, 
Finland. Available at: https://echa.europa.eu/documents/10162/073d44ca-5ad2-8128-fd15-8c74a4bdb126, accessed on 05.01.2023 
3: Austria (2021) Grenzwerteverordnung 2021 – GKV. Available at: https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20001418, accessed on 02.12.2022 
4:  Belgium  (2022)  List  of  limit  values  (Titel  1.  –  Chemische  agentia.  and  Titel  2.  –  Kankerverwekkende,  mutagene  en  reprotoxische  agentia).  Available  at:  https://werk.belgie.be/nl/themas/welzijn-op-het-werk/algemene-
beginselen/codex-over-het-welzijn-op-het-werk, accessed on 02.12.2022 
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https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/D74ACEE6A814B7EAC2257E03002A76C9?OpenDocument, accessed on 05.12.2022 
8: Czechia (2022) List of limit values. Available at: https://www.tzb-info.cz/pravni-predpisy/narizeni-vlady-c-361-2007-sb-kterym-se-stanovi-podminky-ochrany-zdravi-pri-praci, accessed on 05.12.2022 
9: Denmark (2022) List of limit values. Available at: https://www.retsinformation.dk/eli/lta/2022/1054, accessed on 05.12.2022 
10: Estonia (2022) List of limit values. Available at: https://www.riigiteataja.ee/aktilisa/1120/3202/2025/VV_30m_lisa.pdf#, accessed on 05.12.2022 
11: Finland (2020) List of limit values. Available at: https://julkaisut.valtioneuvosto.fi/handle/10024/162457, accessed on 05.12.2022 
12: France (2022) List of limit values. Available at: https://www.inrs.fr/media.html?refINRS=outil65, accessed on 05.12.2022 
13: Germany (2022) List of limit values (TRGS 900). Available at: https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-Regeln/Regelwerk/TRGS/TRGS-900.html, accessed on 05.12.2022 
14: Greece (2019) List of limit values. Available at: https://www.elinyae.gr/sites/default/files/2019-10/oriakes%20times%202019_L_0.pdf, accessed on 05.12.2022 
15: Hungary (2022) List of limit values. Available at: https://net.jogtar.hu/jogszabaly?docid=a2000005.itm, accessed on 05.12.2022 
16:  Ireland  (2021)  List  of 
regulations.pdf, accessed on 05.12.2022 

limit  values.  Available  at:  https://www.hsa.ie/eng/publications_and_forms/publications/chemical_and_hazardous_substances/2021-code-of-practice-for-the-chemical-agents-and-carcinogens-

235 

 
 
 
 
 
of 

of 

in 

of 

at: 

at: 

list 

List 

and 

and 

and 

limit 

limit 

from 

2020 

2018 

values 

values 

(2020) 

(2018) 

(2020). 

Available 

carcinogens 

amendments 

Luxembourg 

(2021)  List 

and  mutagens 

2021.  Available 

http://legilux.public.lu/eli/etat/leg/rgd/2018/07/20/a684/jo 

https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20180001286/O/D20181286.pdf, 

17: Italy (2022) List of limit values and amendments. Available at: https://www.ispettorato.gov.it/it-it/strumenti-e-servizi/Documents/TU-81-08-Ed.-Agosto-2022.pdf, accessed on 06.12.2022 
18: Latvia (2022) List of limit values. Available at: https://likumi.lv/doc.php?id=157382&from=off, accessed on 06.12.2022 
19: Lithuania (2022) List of limit values. Available at: https://www.e-tar.lt/portal/lt/legalAct/TAR.8012ED3EA143/asr, accessed on 06.12.2022 
20: 
http://legilux.public.lu/eli/etat/leg/rgd/2020/01/24/a37/jo, accessed on 06.12.2022 
21: Malta (2021) List of limit values. Available at: https://legislation.mt/eli/sl/424.24/eng/pdf, accessed on 06.12.2022 
22: Netherlands (2022) List of limit values. Available at: https://wetten.overheid.nl/BWBR0008587/2022-07-01#BijlageXIII, accessed on 06.12.2022 
23:  Poland 
and 
http://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20200000061, and https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20210000325/O/D20210325.pdf, accessed on 06.12.2022 
24: Portugal (2022) List of limit values. Available at: https://dre.pt/dre/legislacao-consolidada/decreto-lei/2012-115495237, accessed on 07.12.2022 
25: Romania (2021) List of limit values. Available at: https://legislatie.just.ro/Public/DetaliiDocument/75978, accessed on 07.12.2022 
26: Slovakia (2020) List of limit values. Available at: https://www.epi.sk/zz/2006-355, accessed on 07.12.2022 
27: Slovenia (2021) List of limit values. Available at: http://www.pisrs.si/Pis.web/pregledPredpisa?id=PRAV14252, accessed on 07.12.2022 
28: Spain (2022) List of limit values. Available at: https://www.insst.es/el-instituto-al-dia/limites-de-exposicion-profesional-para-agentes-quimicos-2022, accessed on 07.12.2022 
29: Sweden (2022) List of limit values and amendments. Available at: https://www.av.se/arbetsmiljoarbete-och-inspektioner/publikationer/foreskrifter/hygieniska-gransvarden-afs-20181-foreskrifter/, accessed on 07.12.2022 
30: European Union, Commission Directive 2009/161/EU of 17 December 2009 establishing a third list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC and amending Commission 
Directive 2000/39/EC. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1548946115483&uri=CELEX:32017L2398, accessed on 07.12.2022 
31: Australia (2022) List of limit values. Available at: https://www.safeworkaustralia.gov.au/doc/workplace-exposure-standards-airborne-contaminants-2022, accessed on 05.01.2023 
32: Brazil (2021) List of limit values. Available at: https://www.guiatrabalhista.com.br/legislacao/nr/nr-15-anexo-11.pdf, accessed on 05.01.2023 
33: Canada, Ontario (2020) List of limit values. Available at: https://www.ontario.ca/laws/regulation/900833, accessed on 05.01.2023 
34: Canada, Québec (2022) List of limit values. Available at: https://www.legisquebec.gouv.qc.ca/en/document/cr/S-2.1,%20r.%2013, accessed on 05.01.2023 
35: India (2007) List of limit values. Available at: https://dgfasli.gov.in/en/book-page/permissible-levels-certain-chemical-substancesin-work-environment, accessed on 05.01.2023 
36:  Japan  (2022)  List  of  limit  values.  Available  at:  https://www.nite.go.jp/en/chem/chrip/chrip_search/intSrhSpcLst?slIdxNm=&slScNm=RJ_04_061&slScCtNm=&slScRgNm=&ltCatFl=&slMdDplt=0&ltPgCt=200&stMd, 
accessed on 05.01.2023 
37: Japan - JOSH (2022) List of limit values. Available at: https://www.sanei.or.jp/english/files/topics/oels/oel_en.pdf, accessed on 05.01.2023 
38: Norway (2022) List of limit values. Available at: https://lovdata.no/dokument/SF/forskrift/2011-12-06-1358#KAPITTEL_8, accessed on 05.01.2023 
39: Russia (2021) List of limit values. Available at: http://publication.pravo.gov.ru/Document/View/0001202102030022, accessed on 10.12.2022 
40: Switzerland (2022) List of limit values. Available at: https://www.suva.ch/de-ch/services/grenzwerte#gnw-location=%2F, accessed on 05.01.2023 
41: Turkey (2013) List of limit values. Available at: https://www.resmigazete.gov.tr/eskiler/2013/08/20130812-1.htm, accessed on 05.01.2023 
42: United Kingdom (2020) List of limit values. Available at: https://www.hse.gov.uk/pubns/priced/eh40.pdf, accessed on 05.01.2023 
43: ACGIH, American Conference of Governmental Industrial Hygienists (2022), TLVs and BEIs Based on the Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure 
Indices. 
44: USA, NIOSH (2022) List of limit values. Available at: https://www.cdc.gov/niosh/index.htm, accessed on 05.01.2023 
45: USA, OSHA (2022) List of limit values. Available at: https://www.osha.gov/dsg/annotated-pels/tablez-1.html, accessed on 05.01.2023 
46: Albania (2014) Albania (2014) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/115604/ALB-115604.pdf; accessed on 26.03.2024 
46: Bosnia and Herzegovina (2020) Law on protection at work - part one. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/112339/BIH-112339.pdf; accessed on 26.03.2024 
48: Georgia (2014) List of permissible concentrations of metals in the air of the working area. Available at: https://matsne.gov.ge/ka/document/view/2198163?publication=0, accessed on 28.03.2024 
49: Moldova (2013) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/97247/PDF.pdf, accessed on 26.03.2024 
50: Montenegro (2023) List of carcinogens and mutagens. Available at:  and https://www.gov.me/dokumenta/d41be940-6c22-499d-8c32-3619e0a6d332, accessed on 27.03.2024 
52: North Macedonia (2010) List of limit values. Available at: https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/94988/MKD-94988.pdf, accessed on 27.03.2024 

236 

 
 
 
 
52: Serbia (2018) List of limit values. Available at: http://www.socijalnoekonomskisavet.rs/cir/publikacije/propisi%20bzr.pdf, accessed on 28.03.2024 
53:  Ukraine (2020) List of limit values and amendments (2023). Available at: https://zakon.rada.gov.ua/laws/show/z0741-20#Text, accessed on 28.03.2024 

4. 

ISOPRENE 

4.1.  Relevant sectors with exposed workers 

Table 96 - relevant sectors with risk of exposure to isoprene 

Short name for sector 

NACE description 

NACE 
code 
C19.20 

Manufacture 
of 
petroleum products 

refined 

C20.17 

Manufacture  of 
rubber in primary forms 

synthetic 

Source: RPA (2024) 

fuels  or  other  products 

This  class  includes  the  manufacture  of  liquid  or 
from  crude 
gaseous 
petroleum, bituminous minerals or their fractionation 
products. Petroleum refining involves one or more of 
the following activities:  
fractionation;  
straight distillation of crude oil; and  
cracking. 
This class includes:  
Manufacture of synthetic rubber in primary forms 
    Synthetic rubber 
    Factice 
Manufacture  of  mixtures  of  synthetic  rubber  and 
natural rubber or rubber-like gums (e.g. balata) 

237 

 
 
 
 
 
4.2.  Estimated number of enterprises with exposed workers in the EU 

Table 97 – estimated number of EU enterprises with exposed workers by sector and by size of enterprise  

Sector 

C19.20 

C20.17 

Manufacture of refined petroleum 
products 
Manufacture of synthetic rubber in 
primary forms 

Source: RPA (2024) 

Number of enterprises 
Small      <50 
employees 

- 

53 

Medium    50-249 
employees 

Large    >249 
employees 

Total 

- 

7 

18 

2 

18 

62 

4.3.  Estimated number of exposed workers in the EU 

Sector 

Table 98 – estimated number of workers in the EU exposed to cobalt and inorganic cobalt compounds  
Number of 
companies with 
exposed workers 

Total number of 
workers in companies 

Number of 
exposed 
workers 

Number exposed 
per company 

Manufacture  of  refined  petroleum 
products 

Manufacture of synthetic rubber in 
primary forms 

C19.20 

C20.17 

Total 

10,266  

273  

10,539 

33,666  

2,726  

36,392 

570  

4  

132 

18  

62  

80 

238 

Percentage 
exposed in 
companies 

28% 

10% 

 
 
 
 
 
 
Source: RPA (2024) 

4.4.  Exposure concentrations by sectors 

Table 99 - summary of exposure concentrations (in mg/m3) by sectors, without adjustment for the use of RPE.  

Sector 

AM 

Median 

P75 

P90 

P95 

Max 

C19.20 
C20.17 

Manufacture of refined petroleum products 
Manufacture of synthetic rubber in primary 
forms 

Source: RPA (2024) 

4.5.  Current risk management measures 

0.20 
0.25 

0.11 
0.21 

0.23 
0.31 

0.44 
0.43 

0.65 
0.52 

1.36 
0.76 

Table 100 –  Companies’ use of RMMs for individual process by sector 

Measure 
Substitution 
Discontinuation 
Reduce use 
Reduce workers 
Rotate workers 
Redesign 
Closed systems 
Partial hood 
Open hoods 
General ventilation 

C19.20 

14% (1) 

86% (6) 

71% (5) 

C20.17 

60% (3) 

60% (3) 

40% (2) 
80% (4) 

239 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pressurised control cabs 
Simple control cabs 
RPE 
HEPA 
Masks 
Goggles 
Gloves 
Continuous measurement to detect unusual exposures 
Training 
Cleaning 
Creating a culture of safety 
Personal hygiene (e.g. daily cleaning of work clothing, obligatory shower) 
Provision of separate storage facilities for work clothes 
Total number of processes analysed in sector 
Source: RPA (2024), stakeholder consultation 

57% (4) 

71% (5) 

71% (5) 
71% (5) 

71% (5) 
71% (5) 
71% (5) 
71% (5) 
71% (5) 
7 

20% (1) 

40% (2) 

40% (2) 
60% (3) 
100% (5) 

100% (5) 
60% (3) 
60% (3) 
60% (3) 
100% (5) 
5 

4.6.  Risk management measures required to achieve compliance 

Table 101: RMMs required to meet policy options, % of processes (in brackets: number of processes) 

RMMs 
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Sector 
(n) 

OEL: 
mg/ m³ 

C19.20 Manufacture of refined petroleum products (7) 

14
% 
(1) 
57
% 
(4) 
57
% 
(4) 
57
% 
(4) 
57
% 
(4) 

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% 
(3) 

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% 
(5) 

71
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(5) 

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(5) 

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% 
(5) 

71
% 
(5) 

Current 

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8.5  

1.3 

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% 
(1) 
14
% 
(1) 
29
% 
(2) 
14
% 
(1) 

C20.17 Manufacture of synthetic rubber in primary forms (5) 

60
% 
(3) 

60
% 
(3) 

60
% 
(3) 

10
0% 
(5) 

10
0% 
(5) 

Current  

129.4  

40.0  

8.5  

10
0% 
(5) 
10
0% 
(5) 
10
0% 
(5) 

43
% 
(3) 

71
% 
(5) 

71
% 
(5) 

71
% 
(5) 

71
% 
(5) 

71
% 
(5) 

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% 
(1) 

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71
% 
(5) 

57
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(4) 

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(2) 

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(1) 

241 

 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
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Source: RPA (2024), stakeholders survey 

40
% 
(2) 

242 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
4.7.  National limit value(s) 

Table 102 - current OELs and STELs in EU Member States and selected non-EU countries 

Country 

OEL [mg/m³] 

Specification of 
OEL 

STEL 
[mg/m³] 

Specification of 
STEL 

-  15  min  average 
value, Carc 

-  15  min  average 
value 

- Carc 

- Carc  

- Carc 

Austria 3 
Belgium 4 
Bulgaria 5 
Croatia 6 
Cyprus 7 
Czechia 8 
Denmark 9 
Estonia 10 
Finland 11 
France 12 
Germany 1,2,13 

Greece 14 
Hungary 15 
Ireland 16 
Italy 17 
Latvia 1,2,18 
Lithuania 19 
Luxembourg 20 
Malta 21 
Netherlands 22 
Poland 1,2,23 

- 
- 
40 ** 
- 
- 
- 
- 
- 
- 
- 
8.4 * 

- 
- 
- 
- 
40 ** 
40 ** 
- 
- 
- 
100 ** 

Portugal 24 
Romania 25 
Slovakia 26 
Slovenia 27 
Spain 28 
Sweden 29 
European Union 
RAC 2 
EU candidate countries 
Albania 45 
Bosnia and Herzegovina 
46 
Georgia 47 
Moldova 48 
Montenegro 49 
North Macedonia 50 
Serbia 51 
Turkey 41 
Ukraine 52 
Non-EU countries 
Australia 30 
Brazil 31 
Canada, Ontario 32 

- 
- 
- 
- 
- 
- 
- 
8.5 

- 
- 

- 
- 
- 
- 
- 
- 
- 

- 
- 
- 

- 
- 
- 
- 
- 
- 
- 
- 
- 
- 
67.2 * 

- 
- 
- 
- 
- 
- 
- 
- 
- 
300 ** 

- 
- 
- 
- 
- 
- 
- 
- 

- 
- 

- 
- 
- 
- 
- 
- 
- 

- 
- 
- 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Canada, Québec 33 
China  
India 34 
Japan, MHLW 35 
Japan, JOSH 1,36 
Norway 37 
Russia 38 
South Korea 
Switzerland 1,2,39 
United Kingdom 41 
USA, ACGIH 42 
USA, NIOSH 43 
USA, OSHA 44 
Source: RPA (2024) 

- 
- 
- 
- 
8.4 ^^^ 
- 
40 (V) % 
- 
8.5 * 
- 
- 
- 
- 

- Carc 

- Carc 

- 
- 
- 
- 
- 
- 
- 
- 
68 * 
- 
- 
- 
- 

- Carc 

Notes: 
RAC = Committee for Risk Assessment 
MHLW = Ministry of Health, Labour and Welfare 
JSOH = Japan Society for Occupational Health 
ACGIH = American Conference of Governmental Industrial Hygienists 
NIOSH = National Institute for Occupational Safety and Health 
OSHA = Occupational Safety and Health Administration 
(V) = vapour 
* Binding value according to country-specific source 
** Binding value according to reply of member state authority on questionnaire 
*** Binding value according to report on OEL-deriving systems from 2018. Status was not checked since 2018. 
^ Indicative value according to country-specific source 
^^ Indicative value according to reply of member state authority on questionnaire 
^^^ Indicative value according to the Final report for OEL/STEL deriving systems from 2018. Status was not checked since 2018. 

% According to (country-specific source) unclear if value is binding or indicative  
Carc = notation for carcinogenicity 
- no value available  

– 

of 

List 

limit 

2021 

GKV. 

values 

(2021) 

(2021) 

Austria 

Bulgaria 

Grenzwerteverordnung 

Sources: 
1: Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) GESTIS– International Limit Values. Available at: 
http://limitvalue.ifa.dguv.de/, accessed on 02.12.2022 
2: RAC, Committee for Risk Assessment (2022) ANNEX 1 in support of the Committee for Risk Assessment (RAC) for evaluation of  limit values for 
isoprene at the workplace. European Chemicals Agency (ECHA), Helsinki, Finland. Available at: https://echa.europa.eu/documents/10162/d311e1fc-
b625-7847-d946-d6510c0b5e1d, accessed on 05.01.2023 
3: 
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20001418, accessed on 02.12.2022 
4:  Belgium  (2022)  List  of  limit  values  (Titel  1.  –  Chemische  agentia.  and  Titel  2.  –  Kankerverwekkende,  mutagene  en  reprotoxische  agentia). 
Available at: https://werk.belgie.be/nl/themas/welzijn-op-het-werk/algemene-beginselen/codex-over-het-welzijn-op-het-werk, accessed on 02.12.2022 
5: 
at: 
of 
https://www.lex.bg/laws/ldoc/2135477597 and https://www.lex.bg/bg/mobile/ldoc/2135473243, accessed on 05.12.2022 
6: Croatia (2021) List of limit values. Available at: https://narodne-novine.nn.hr/clanci/sluzbeni/2021_01_1_10.html, accessed on 05.12.2022 
7:  Cyprus 
and 
https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/E3237CC15BD91575C2257E030029E9FF?OpenDocument 
https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/D74ACEE6A814B7EAC2257E03002A76C9?OpenDocument, accessed on 05.12.2022 
8:  Czechia  (2022)  List  of  limit  values.  Available  at:  https://www.tzb-info.cz/pravni-predpisy/narizeni-vlady-c-361-2007-sb-kterym-se-stanovi-
podminky-ochrany-zdravi-pri-praci, accessed on 05.12.2022 
9: Denmark (2022) List of limit values. Available at: https://www.retsinformation.dk/eli/lta/2022/1054, accessed on 05.12.2022 
10: Estonia (2022) List of limit values. Available at: https://www.riigiteataja.ee/aktilisa/1120/3202/2025/VV_30m_lisa.pdf#, accessed on 05.12.2022 
11: Finland (2020) List of limit values. Available at: https://julkaisut.valtioneuvosto.fi/handle/10024/162457, accessed on 05.12.2022 
12: France (2022) List of limit values. Available at: https://www.inrs.fr/media.html?refINRS=outil65, accessed on 05.12.2022 
13:  Germany 
Regeln/Regelwerk/TRGS/TRGS-900.html, accessed on 05.12.2022 
14: Greece (2019) List of limit values. Available at: https://www.elinyae.gr/sites/default/files/2019-10/oriakes%20times%202019_L_0.pdf, accessed 
on 05.12.2022 
15: Hungary (2022) List of limit values. Available at: https://net.jogtar.hu/jogszabaly?docid=a2000005.itm, accessed on 05.12.2022 

(TRGS  900).  Available  at:  https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-

carcinogenic/mutagenic/reprotoxic 

carcinogenic-mutagenic 

(2021)  Legislation 

agents.  Available 

(2022)  List  of 

limit  values 

substances. 

legislation 

Available 

Available 

chemical 

at: 
and 

agents 

and 

list 

at: 

on 

on 

244 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
of 

in 

of 

of 

of 

at: 

at: 

list 

List 

List 

and 

and 

and 

and 

List 

limit 

limit 

limit 

limit 

from 

2018 

2020 

2021. 

values 

values 

(2022) 

(2021) 

(2021) 

values. 

Poland 

Ireland 

Sweden 

Available 

Available 

Available 

carcinogens 

amendments 

amendments. 

(2020)  List 

(2018)  and 

and  mutagens 

(2020).  Available  at: 

https://www.av.se/arbetsmiljoarbete-och-

of 
16: 
https://www.hsa.ie/eng/publications_and_forms/publications/chemical_and_hazardous_substances/2021-code-of-practice-for-the-chemical-agents-
and-carcinogens-regulations.pdf, accessed on 05.12.2022 
17: Italy (2022) List of limit values and amendments. Available at:  https://www.ispettorato.gov.it/it-it/strumenti-e-servizi/Documents/TU-81-08-Ed.-
Agosto-2022.pdf, accessed on 06.12.2022 
18: Latvia (2022) List of limit values. Available at: https://likumi.lv/doc.php?id=157382&from=off, accessed on 06.12.2022 
19: Lithuania (2022) List of limit values. Available at: https://www.e-tar.lt/portal/lt/legalAct/TAR.8012ED3EA143/asr, accessed on 06.12.2022 
20:  Luxembourg 
http://legilux.public.lu/eli/etat/leg/rgd/2018/07/20/a684/jo and http://legilux.public.lu/eli/etat/leg/rgd/2020/01/24/a37/jo, accessed on 06.12.2022 
21: Malta (2021) List of limit values. Available at: https://legislation.mt/eli/sl/424.24/eng/pdf, accessed on 06.12.2022 
22: Netherlands (2022) List of limit values. Available at: https://wetten.overheid.nl/BWBR0008587/2022-07-01#BijlageXIII, accessed on 06.12.2022 
at: 
23: 
https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20180001286/O/D20181286.pdf, 
http://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20200000061, 
https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20210000325/O/D20210325.pdf, accessed on 06.12.2022 
24: Portugal (2022) List of limit values. Available at: https://dre.pt/dre/legislacao-consolidada/decreto-lei/2012-115495237, accessed on 07.12.2022 
25: Romania (2021) List of limit values. Available at: https://legislatie.just.ro/Public/DetaliiDocument/75978, accessed on 07.12.2022 
26: Slovakia (2020) List of limit values. Available at: https://www.epi.sk/zz/2006-355, accessed on 07.12.2022 
27: Slovenia (2021) List of limit values. Available at: http://www.pisrs.si/Pis.web/pregledPredpisa?id=PRAV14252, accessed on 07.12.2022 
28: Spain (2022) List of limit values. Available at:  https://www.insst.es/el-instituto-al-dia/limites-de-exposicion-profesional-para-agentes-quimicos-
2022, accessed on 07.12.2022 
29: 
values 
inspektioner/publikationer/foreskrifter/hygieniska-gransvarden-afs-20181-foreskrifter/, accessed on 07.12.2022 
30:  Australia  (2022)  List  of  limit  values.  Available  at:  https://www.safeworkaustralia.gov.au/doc/workplace-exposure-standards-airborne-
contaminants-2022, accessed on 05.01.2023 
31: Brazil (2021) List of limit values. Available at: https://www.guiatrabalhista.com.br/legislacao/nr/nr-15-anexo-11.pdf, accessed on 05.01.2023 
32: Canada, Ontario (2020) List of limit values. Available at: https://www.ontario.ca/laws/regulation/900833, accessed on 05.01.2023 
33: Canada, Québec (2022) List of limit values. Available at:  https://www.legisquebec.gouv.qc.ca/en/document/cr/S-2.1,%20r.%2013, accessed on 
05.01.2023 
34:  India  (2007)  List  of  limit  values.  Available  at:  https://dgfasli.gov.in/en/book-page/permissible-levels-certain-chemical-substancesin-work-
environment, accessed on 05.01.2023 
35: 
at: 
Japan 
https://www.nite.go.jp/en/chem/chrip/chrip_search/intSrhSpcLst?slIdxNm=&slScNm=RJ_04_061&slScCtNm=&slScRgNm=&ltCatFl=&slMdDplt=
0&ltPgCt=200&stMd, accessed on 05.01.2023 
36: Japan - JOSH (2022) List of limit values. Available at: https://www.sanei.or.jp/english/files/topics/oels/oel_en.pdf, accessed on 05.01.2023 
37:  Norway  (2022)  List  of  limit  values.  Available  at:  https://lovdata.no/dokument/SF/forskrift/2011-12-06-1358#KAPITTEL_8,  accessed  on 
05.01.2023 
38: Russia (2021) List of limit values. Available at: http://publication.pravo.gov.ru/Document/View/0001202102030022, accessed on 10.12.2022 
39:  Switzerland  (2022)  List  of  limit  values.  Available  at:  https://www.suva.ch/de-ch/services/grenzwerte#gnw-location=%2F,  accessed  on 
05.01.2023 
40: Turkey (2013) List of limit values. Available at: https://www.resmigazete.gov.tr/eskiler/2013/08/20130812-1.htm, accessed on 05.01.2023 
41: United Kingdom (2020) List of limit values. Available at: https://www.hse.gov.uk/pubns/priced/eh40.pdf, accessed on 05.01.2023 
42: ACGIH, American Conference of Governmental Industrial Hygienists (2022), TLVs and BEIs Based on the Documentation of the Threshold Limit 
Values for Chemical Substances and Physical Agents and Biological Exposure Indices. 
43: USA, NIOSH (2022) List of limit values. Available at: https://www.cdc.gov/niosh/index.htm, accessed on 05.01.2023 
44: USA, OSHA (2022) List of limit values. Available at: https://www.osha.gov/dsg/annotated-pels/tablez-1.html, accessed on 05.01.2023 
45:  Albania  (2014)  Albania  (2014)  List  of  limit  values.  Available  at:  https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/115604/ALB-
115604.pdf; accessed on 26.03.2024 
46: 
- 
https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/112339/BIH-112339.pdf; accessed on 26.03.2024 
47:  Georgia 
https://matsne.gov.ge/ka/document/view/2198163?publication=0, accessed on 28.03.2024 
48:  Moldova  (2013)  List  of  limit  values.  Available  at:  https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/97247/PDF.pdf,  accessed  on 
26.03.2024 
49:  Montenegro  (2023)  List  of  carcinogens  and  mutagens.  Available  at:    and  https://www.gov.me/dokumenta/d41be940-6c22-499d-8c32-
3619e0a6d332, accessed on 27.03.2024 
50:  North  Macedonia  (2010)  List  of  limit  values.  Available  at:  https://wwwex.ilo.org/dyn/natlex2/natlex2/files/download/94988/MKD-94988.pdf, 
accessed on 27.03.2024 
51:  Serbia  (2018)  List  of  limit  values.  Available  at:  http://www.socijalnoekonomskisavet.rs/cir/publikacije/propisi%20bzr.pdf,  accessed  on 
28.03.2024 
52:    Ukraine  (2020)  List  of  limit  values  and  amendments  (2023).  Available  at:  https://zakon.rada.gov.ua/laws/show/z0741-20#Text,  accessed  on 
28.03.2024 

the  working  area.  Available  at: 

(2014)  List  of  permissible 

concentrations  of  metals 

the  air  of 

Herzegovina 

protection 

Available 

Available 

values. 

Bosnia 

(2020) 

(2022) 

work 

limit 

Law 

one. 

part 

and 

List 

at: 

on 

at 

of 

in 

245 

 
 
 
 
 
5.  WELDING FUMES 

5.1.  Relevant sectors with exposed workers 

Table 103 - relevant sectors with risk of exposure to welding fumes  

NACE 
code 

Short name for sector 

Description of activities with exposure to welding 
fumes containing CMR substances 

Manufacture of basic metals  Welding processes, cutting during manufacture of 

C24 

C25 

C26 

C28 

C29 

C30 

C31 
C32 
C33 

E38 

F41 
F42 
F43 

Manufacture of fabricated 
metal products (excl.  
machinery & equipment) 
Manufacture of computer, 
electronic & optical products 
Manufacture of machinery & 
equipment 
Manufacture of motor 
vehicles, trailers & semi-
trailers 
Manufacture of other 
transport equipment 
Manufacture of furniture 
Other manufacturing 
Repair & installation of 
machinery & equipment 
Waste collection, treatment 
& disposal, materials 
recovery 
Construction of buildings 
Civil engineering 
Specialised construction 
activities 
Motor trade & repair 

G45 
Source: RPA (2024) 

steel tubes, pipes etc.   
Welding processes, cutting, coating (spraying) 

Welding processes, soldering 

Welding, cutting, coating (spraying) 

Welding, cutting, coating (spraying) 

Welding, cutting, coating (spraying) 

Welding, cutting, coating (spraying) 
Welding, cutting, coating (spraying) 
Welding, soldering 

Cutting up metal products for materials recovery. 

Welding processes 
Welding processes 
Welding processes, soldering electronics or soldering 
pipework. 
Welding processes: resistance spot welding 

246 

 
 
 
 
 
5.2.  Estimated number of enterprises with exposed workers in the EU 

Table 104 – estimated number of EU enterprises with exposed workers by sector and by size of enterprise 

Sector 

Eurostat employees 

Estimated % of employees 
undertaking welding+ activities 

Estimated exposed welders 

Small  Medium 

Large 

Small  Medium 

C24 Basic metals 
C25 Fabricated metal products 
C28 Machinery & equipment 
C29 Motor vehicles,  
C30 Manufacture of other transport 
equipment 

Small 

6,796 
310,557 
13,986 
20,972 
12,965 

Medium 
28,248 
440,532 
72,276 
103,170 
42,800 

Large 
359,499 
608,374 
491,722 
1,088,100 
452,577 

Total 
394,543 
1,359,463 
577,984 
1,212,242 
508,342 

4,844 
4,255 
124,320 

16,420 
514,158 
38,850 
1,026,404 

21,318 
16,104 
117,306 

22,470 
243,450 
86,700 
310,833 

26,598 
30,767 
250,452 

50,320 
301,902 
374,544 
428,901 

52,760 
51,126 
492,078 

89,210 
1,059,510 
500,094 
1,766,138 

C31 Furniture 
C32 Other manufacturing 
C33 Repair & installation of 
machinery & equipment 
E38 Materials recovery 
F41 Construction of buildings 
F42 Civil engineering 
F43 Specialised construction 
activities 
G45 Repair of motor vehicles & 
motorcycles 
Total 
Source: RPA (2024) 

25% 
25% 
25% 
25% 
25% 

40% 
40% 
40% 

40% 
40% 
40% 
40% 

10% 
10% 
10% 
10% 
10% 

10% 
10% 
10% 

10% 
10% 
10% 
10% 

5% 
5% 
5% 
5% 
5% 

5% 
5% 
5% 

5% 
5% 
5% 
5% 

5% 

- 

1,699.00 
2,826 
77,640.00  44,055 
7,228 
3,497.00 
10,317 
5,243.00 
4,280 
3,241.00 

Large 
17,975 
30,418 
24,586 
54,405 
22,629 

Total 

22,500 
152,113 
35,311 
69,965 
30,150 

1,938.00 
1,702.00 
49,728 

2,132 
1,611 
11,731 

6,568 
205,663 
15,540 
410,562 

2,247 
24,345 
8,670 
31,084 

1,330 
1,539 
12,523 

2,516 
15,095 
18,727 
21,445 

5,400 
4,852 
73,982 

11,331 
245,103 
42,937 
463,091 

Estimated 
distributi
on across 
sectors 

1.8% 
11.9% 
2.8% 
5.5% 
2.4% 

0.4% 
0.4% 
5.8% 

0.9% 
19.2% 
3.4% 
36.2% 

295,094 

37,032 

28,330 

360,456 

40% 

10% 

2,389,621 

1,542,239 

4,492,086 

8,423,946 

- 

- 

118,037 

3,703 

1,417 

123,157 

9.6% 

901,058 

154,229 

224,605 

1,279,892 

100% 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.3.  Estimated number of exposed workers in the EU 

Table 105 – estimated number of workers in the EU exposed to cobalt and inorganic cobalt 
compounds  

Sector 

Estimated number of 
exposed workers 

% of exposed 
workers 
distributed across 
sectors 

C24 
C25 

C28 
C29 

C30 
C31 
C32 
C33 

Manufacture of basic metals 
Manufacture of fabricated metal products 
(excl.  machinery & equipment) 
Manufacture of machinery & equipment 
Manufacture of motor vehicles, trailers & 
semi-trailers 
Manufacture of other transport equipment 
Manufacture of furniture 
Other manufacturing 
Repair & installation of machinery & 
equipment 

22,500 
152,113 

35,311 
69,965 

30,150 
5,400 
4,852 
73,982 

E38  Waste collection, treatment & disposal, 

11,331 

materials recovery 
Construction of buildings 
F41 
Civil engineering 
F42 
F43 
Specialised construction activities 
G45  Wholesale & retail trade & repair of motor 

vehicles & motorcycles 

Total 
Source: RPA (2024) 

245,103 
42,937 
463,091 
123,157 

1,279,892 

5.4.  Exposure concentrations by sectors 

No data available. 

5.5.  Current risk management measures 

1.8% 
11.9% 

2.8% 
5.5% 

2.4% 
0.4% 
0.4% 
5.8% 

0.9% 

19.2% 
3.4% 
36.2% 
9.6% 

100% 

Table 106 - RMMs used by the Manufacture of paper and paperboard (C17.12) and Manufacture of 
basic pharmaceutical products and pharmaceutical preparations (C21) sectors 

RMM 

C17.12 Paper (1) 

C21 Pharmaceuticals (1) 

Organisational and hygiene measures 
Blood monitoring 
Culture of safety 

MAG 
(solid 
wire) 

MIG 
solder 

MAG 
(flux) 

MIG 
solder 

MMA  TIG 

1 

1 

1 

1 

1 

1 

248 

 
 
 
 
 
 
  
  
  
  
  
  
Health surveillance  
Regular check of RMM effectiveness 
Training and education  
PPE (Personal Protective Equipment 
Face screens, face shields, visors 
Gloves, goggles, coverall  
Restructuring operations/processes 
Reduced number of workers exposed 
Separate welding from other activities  
Ventilation and extraction 
General ventilation 
Open hoods  

1 
1 
1 

1 
1 

1 
1 

1 

1 
1 
1 

1 
1 

1 
1 

1 

1 
1 

1 
1 

1 
1 

1 
1 

1 
1 

1 
1 

1 
1 

1 
1 

1 

1 
1 

1 
1 

1 
1 

Source: RPA (2024), Stakeholder consultation 2023, 58 responses received. 

Table 107 - RMMs for the Manufacture of glass and glass products (C23.1) and the Manufacture of 
tubes, pipes, hollow profiles and related fittings of steel (C24.2) sectors 

RMM 

C23.1 Glass (1) 

F Spray  MAG 
(flux) 

C24.2 Tubes & 
pipes (1) 
MIG (solid wire, 
Ni) 

Organisational and hygiene measures 
Blood monitoring 
Culture of safety 
Health surveillance  
Regular check of RMM effectiveness  
Training and education 
PPE (Personal Protective Equipment) 
Disposable respirators (FFP masks) 
Face screens, face shields, visors 
Fan-assisted welding helmets 
Forced ventilation welding helmets 
Gloves, goggles, coverall  
Restructuring operations/processes 
Permanent relocation of workers with health effects of 
welding fumes 
Redesign of work processes 
Reduced number of workers exposed 
Reduced time spent on welding activity 
Rotation of the workers exposed 
Separate welding and associated processes  
Temporary  relocation  of  workers  with  health  effects 
of welding fumes 
Substitution with lower emission welding process 

1 
1 
1 
1 
1 

1 
1 

1 

1 
1 
1 

1 
1 

1 

249 

1 

1 

1 

1 

1 
1 

1 
1 

1 

1 
1 
1 
1 

1 
1 
1 

1 

1 
1 
1 
1 

1 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Ventilation and extraction 
Closed systems 
General ventilation 
Open hoods  
Partially closed systems 
Regular maintenance of extraction equipment 
Separate low volume or high volume spot extraction  
Welding  booth  with  a  welding  table  &  adjustable 
extraction element 
Source: RPA (2024), Stakeholder consultation 2023, 58 responses received. 

1 
1 

1 
1 

1 

1 

1 
1 
1 
1 
1 
1 

Table 108 - RMMs for Aluminium production (C24.42) and Casting of iron (C24.51) sectors 
C24.42 Aluminium (2) 

C24.51 Iron (2) 

RMM 

MIG/MAG  TIG  MIG/MAG  MMA  PC  TIG 

MIG 
(Al) 

1 

2 

1 

1 

2 

2 

1 
1 

1 
1 

2 
2 

1 
2 
2 

2 
2 
2 

Organisational and hygiene measures 
Blood monitoring 
Culture of safety 
Health surveillance  
Training and education  
1 
PPE (Personal Protection Equipment) 
Disposable respirators (FFP masks) 
Face screens, face shields, visors 
Gloves, goggles, coverall  
Restructuring operations/processes 
Reduced number of workers 
exposed 
Reduced time spent on welding 
activity 
Rotation of the workers exposed 
Separate welding and associated 
processes  
Ventilation and extraction 
General ventilation 
Open hoods  
Regular maintenance  
Welding torch-integrated extraction 
system 
Source: RPA (2024) Stakeholder consultation 2023, 58 responses received. 

2 
2 
2 

1 
1 
1 

1 
1 

1 
1 

2 

2 

1 

1 

1 

2 

1 

1 

1 

1 
1 

1 
1 
1 

1 

1 

1 
1 
1 

1 

1 
1 

1 
1 
1 

2 

2 
2 

2 
2 
2 

1 

2 

1 

2 

1 
1 
1 

2 
2 
2 

Table 109 - RMMs used by the Manufacture of fabricated metal products sector (C25) 

RMM 

C25 Metal products (8) 

3D printing 

Auto flame cutting 

Brazing 

Organisational and hygiene measures 

250 

 
 
 
 
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
1 

1 

1 

2 

1 

(FFP 

Blood monitoring 
Culture of safety 
mask cleaning & filter changing  
Training and education 
PPE (Personal Protection Equipment) 
Disposable 
respirators 
masks) 
Face screens, face shields, visors 
Gloves, goggles, coverall  
Half  and  full  facemasks  (negative 
pressure respirators) 
Welding  helmets  with  a  separate 
air supply 
Restructuring operations/processes 
Reduced  number  of  workers 
exposed 
Reduced  time  spent  on  welding 
activity 
Temporary  relocation  of  workers 
with  health  effects  of  welding 
fumes 
Partial substitution of content base 
material and addition material  
welding+ 
Substitution 
processes  with  other 
joining 
processes (gluing, folding, screws, 
rivets etc) 
Substitution  with  lower  emission 
welding+ process 
Ventilation and extraction 
Closed systems 
General ventilation 
Open hoods  
Partially closed systems 
Pressurised or sealed control cabs 
Regular maintenance of extraction 
equipment 
Simple enclosed control cabs 
Welding  booth  with  a  welding 
table  &  adjustable  extraction 
element 
Source: RPA (2024) Stakeholder consultation 2023, 58 responses received. 

1 
2 

1 
1 

of 

1 

1 

1 

1 

1 

1 

1 
1 
1 
2 

3 

2 
1 
1 

2 

1 

1 

1 

1 
1 
1 

1 

1 

Table 110 - RMMs used by the Manufacture of fabricated metal products sector (C25) continued. 

RMM 

MAG  MAG  MAG 

C25 Metal products (8) 
MIG 

F 

MIG  MIG 

251 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
spray 

(flux, 
shielding 
gas) 

(flux) 

(solid 
wire) 

(aluminium 
materials) 

solder 

(solid 
wire, 
Ni) 

1 

1 

1 

1 

1 
1 

Organisational and hygiene measures 
Blood monitoring 
Culture of safety 
Mask cleaning & filter 
changing  
Health surveillance  
Regular check of RMM 
effectiveness  
Training and education  
PPE (Personal Protective Equipment) 
Disposable respirators 
(FFP masks) 
Face screens, face 
shields, visors 
Fan-assisted welding 
helmets 
Forced ventilation 
welding helmets 
Gloves, goggles, coverall 
Half and full facemasks 
(negative pressure 
respirators) 
Powered air-purifying 
respirators 
Welding helmets with a 
separate air supply 
Restructuring operations/processes 
Reduced time spent on 
welding activity 
Separate welding+ 
associated processes  
Partial substitution of 
content base material and 
addition material  
Substitution with lower 
emission welding+ 
process 
Ventilation & extraction 
Closed systems 
General ventilation 
Open hoods  
Partially closed systems 
Pressurised or sealed 
control cabs 

1 
1 

1 
1 

1 

2 

7 

1 

1 

1 
2 
2 

1 

1 

1 

1 

1 

1 

2 
1 

3 

2 

1 

2 

1 

1 

2 
1 
1 

4 
3 

3 
3 

10 

4 

4 

2 

7 
1 

1 

4 

1 

2 

1 

1 
8 
7 
1 

1 
2 
1 

2 
1 

3 

1 

3 

1 

1 

1 

1 

2 

1 

1 

1 
2 
2 
2 
1 

1 

1 
1 

1 

1 

1 

1 
1 

252 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
2 

2 

4 

1 

1 

2 

3 

Regular maintenance of 
extraction equipment 
Separate low volume or 
high volume spot 
extraction  
Simple enclosed control 
cabs 
Welding booth with a 
welding table and & 
adjustable extraction 
element 
Welding torch-integrated 
extraction system 
Source: RPA (2024) Stakeholder consultation 2023, 58 responses received. 

1 

1 

1 

1 

1 

1 

1 

1 

3 

1 

2 

Table 111 - RMMs used by the Manufacture of fabricated metal products sector (C25) continued. 

RMM 

MIG/MAG  MMA 

C25 Manufacture of fabricated metal products (8) 
SAW 

PC 

Not 
specified 

Soft 
solder 

5 

2 

2 
1 

2 
1 

Organisational and hygiene measures 
Blood monitoring 
Continuous measurement 
of air concentrations to 
detect unusual exposures 
Culture of safety 
Mask cleaning & filter 
changing 
Health surveillance  
Regular check of RMM 
effectiveness  
Training and education  
PPE (Personal Protective Equipment) 
Disposable respirators 
(FFP masks) 
Face screens, face 
shields, visors 
Fan-assisted welding 
helmets 
Forced ventilation 
welding helmets 
Gloves, goggles, coverall 
Half and full facemasks 
(negative pressure 
respirators) 
Powered air-purifying 
respirators 
Welding helmets with a 

2 
2 

1 

3 

1 

4 

4 

1 

1 

1 

2 

5 
2 

2 
2 

6 

2 

4 

4 
1 

3 

2 

4 
1 

1 
2 

7 

3 

5 

6 
1 

1 

1 

2 
1 

2 
2 

2 

1 

2 

1 

1 

4 

253 

TIG 

1 

4 
2 

3 
1 

5 

2 

4 

1 

1 

3 
1 

1 

1 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
1 

1 

1 

1 

1 

1 

1 

separate air supply 
Restructuring operations/processes 
Permanent relocation of 
workers with health 
effects of welding fumes 
Reduced number of 
workers exposed 
Reduced time spent on 
welding activity 
Separate welding+ 
processes  
Temporary relocation of 
workers with health 
effects of welding fumes 
Substitution of content 
base material and 
addition material  
Substitution with lower 
emission welding+ 
process 
Ventilation & extraction 
Closed systems 
General ventilation 
Open hoods  
Partially closed systems 
Regular maintenance of 
extraction equipment 
Separate low volume or 
high volume spot 
extraction  
Simple enclosed control 
cabs 
Welding booth with a 
welding table & 
adjustable extraction 
element 
Welding torch-integrated 
extraction system 
Source: RPA (2024) Stakeholder consultation 2023, 58 responses received. 

2 
1 
2 

4 
3 

6 
3 

1 

4 

1 

1 

4 

3 

1 

1 

2 

1 

1 

2 

1 

1 

7 
7 
7 

2 

1 

1 

1 

2 

2 

1 
5 
2 

3 

2 

2 

1 

Table 112 - RMMs used by the Manufacture of other general-purpose machinery (C25.2) and 
Manufacture of other fabricated metal products (C25.99) sectors. 
RMM 

C25.99 Other metal products 
(1) 
MAG 
(solid 
wire) 

LB 
cutting 

TIG 

C25.2 Other 
machinery 

SAW 

MAG 
(solid 
wire) 

254 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
1 

1 

1 
1 
1 

1 

1 

1 

1 

1 

of 

air 

1 
1 

1 
1 

measurement 

Organisational and hygiene measures 
Continuous 
concentrations to detect unusual exposures 
Culture of safety 
Mask cleaning & filter changing 
Health surveillance  
Regular check of RMM effectiveness  
Training and education  
PPE (Personal Protection Equipment) 
Face screens, face shields, visors 
Forced ventilation welding helmets 
Gloves, goggles, coverall 
Welding helmets with a separate air supply 
Restructuring operations/processes 
Redesign of work processes 
Separate welding and associated processes  
Substitution or discontinuation 
Substitution  of  welding  or  associated 
processes  with  other 
joining  processes 
(gluing, folding, screws, rivets) 
Substitution  with 
lower 
welding+ process 
Ventilation & extraction 
Closed systems 
General ventilation 
Open hoods  
Regular maintenance  
Simple enclosed control cabs 
Welding  booth  with  a  welding  table  and 
adjustable extraction element 
Source: RPA(2024) Stakeholder consultation 2023, 58 responses received. 

emission 

1 
1 
1 

1 

1 

1 

1 

1 

a 

1 

1 

1 

1 
1 
1 
1 
1 
1 

1 

1 

1 
1 
1 

1 

1 

1 

1 
1 
1 

1 

1 

1 
1 
1 

1 

1 

1 

1 
1 
1 

Table 113 - RMMs used by the Manufacture of machinery and equipment (C28) sector. 

RMM 

Brazing  LB cutting 
(additional 
materials) 

C28 Machinery & equipment (5) 
MIG 
(solid 
wire, 
Ni) 

MAG 
(flux, 
shielding 
gas) 

MAG 
(solid 
wire) 

MIG/MAG  

Organisational and hygiene measures 
Blood monitoring 
Continuous  measurement  of  air 
concentrations  to  detect  unusual 
exposures 
Culture of safety 
cleaning 
Mask 

filter 

and 

1 
1 

2 
1 

1 

1 

1 
1 

1 
3 

3 
3 

1 

1 

255 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
1 

1 

1 

1 

1 

1 

1 

2 

1 

2 

1 

of 

of 

and 

2 
1 

2 
2 

(FFP 

check 

RMM 

education 

changing  
Health surveillance  
Regular 
effectiveness  
Training 
workers 
PPE (Personal Protective Equipment) 
respirators 
Disposable 
masks) 
Face screens, face shields, visors 
Fan-assisted welding helmets 
Gloves, goggles, coverall  
Powered air-purifying respirators 
Welding  helmets  with  a  separate 
air supply 
Restructuring operations/processes 
Redesign of work processes 
Rotation of the workers exposed 
Separate  welding  and  associated 
processes  
Substitution or discontinuation 
Partial  substitution  of  content 
base  material 
addition 
material  
Substitution 
or 
associated  processes  with  other 
joining 
(gluing, 
processes 
folding, screws, rivets) 
Substitution  with 
emission welding+ process 
Ventilation & extraction 
Closed systems 
General ventilation 
Open hoods  
Partially closed systems 
Pressurised or sealed control cabs 
Regular maintenance  
Separate  low  volume  or  high 
volume spot extraction  
Welding  booth  with  a  welding 
table  and  adjustable  extraction 
element 
Welding 
extraction system 
Source: RPA (2024) Stakeholder consultation 2023, 58 responses received. 

torch-integrated 

of  welding 

lower 

2 
1 

1 
1 

and 

2 

1 

1 

2 

a 

1 
1 

1 

1 
1 
1 

1 

1 

1 
1 

1 

1 

1 
1 

1 

1 

1 

1 

1 
1 

1 

1 
1 

1 

1 

1 

3 
4 

4 

1 

3 
1 
3 
2 
1 

1 

3 

1 

2 

1 
3 
4 
2 

3 
1 

3 

1 

256 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
Table 114 - RMMs used by the Manufacture of machinery and equipment (C28) continued, and by the 
Manufacture of motor vehicles, trailers and semi-trailers (C29) sectors. 

RMM 

C28 Machinery 
& equipment (5) 
PC  SAW  TIG  Brazing 

C29 Motor vehicles (2) 

Organisational & hygiene measures 
Blood monitoring 
Continuous measurement of air concentrations to 
detect unusual exposures 
Culture of safety 
Mask cleaning and filter changing  
Health surveillance  
Regular check of RMM effectiveness  
Training and education  
PPE (Personal Protective Equipment) 
Disposable respirators (FFP masks) 
Face screens, face shields, visors 
Fan-assisted welding helmets 
Forced ventilation welding helmets 
Gloves, goggles, coverall  
Half  and  full  facemasks  (negative  pressure 
respirators) 
Powered air-purifying respirators 
Welding helmets with a separate air supply 
Restructuring operations/processes 
Redesign of work processes 
Reduced number of workers exposed 
Rotation of the workers exposed 
Separate  welding  and  associated  processes  with 
emissions from other activities in space or time 
Substitution or discontinuation 
Substitution  of  welding  or  associated  processes 
with  other  joining  processes  (gluing,  folding, 
screws, rivets) 
Substitution  with 
process 
Ventilation and extraction 
Closed systems 
General ventilation 
Open hoods  
Partially closed systems 
Regular maintenance  
Separate  low  volume  or  high  volume  spot 

lower  emission  welding+ 

1 
1 

1 
1 
1 
2 
2 

1 
2 

1 

1 
1 

1 

1 
2 
1 
1 

257 

1 

1 

1 
1 

1 
1 

1 

1 
1 

1 
2 

3 
2 
3 
4 
5 

1 
4 
1 

4 

2 

1 

1 
4 

2 

2 

5 
3 
1 
3 
1 

1 

2 
2 
2 
2 
2 

2 
2 
1 

2 
2 

1 

1 

1 

1 

1 
1 
1 
1 
2 
1 

Gas 
fusion 
welding 

LB 
cutting 

1 

1 

1 
2 
2 

1 

1 
2 

1 

1 

1 

1 

1 
2 

1 

1 

1 
1 
1 

1 
1 

1 

1 

1 
1 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
extraction  
Simple enclosed control cabs 
Welding  booth  with  a  welding 
adjustable extraction element 
Welding torch-integrated extraction system 
Source: RPA (2024) Stakeholder consultation 2023, 58 responses received. 

table  and 

1 

4 

1 

1 

1 

Table 115 - RMMs used by the by the Manufacture of motor vehicles, trailers and semi-trailers (C29) 
sector (continued). 

RMM 

LB 
cutting 

MIG 
(Al) 

C29 Motor vehicles (2) 
MIG 
(solid 
wire, 
Ni) 

MIG 
solder 

MIG/MAG  PC  SAW 

air 
to  detect  unusual 

Organisational and hygiene measures 
Blood monitoring 
Continuous  measurement  of 
concentrations 
exposures 
Culture of safety 
Mask cleaning and filter changing  
Organisation and hygiene measures 
Health  surveillance  in  place  for  these 
process workers 
Regular check of RMM effectiveness  
Training and education  
PPE (Personal Protective Equipment) 
Disposable respirators (FFP masks) 
Face screens, face shields, visors 
Fan-assisted welding helmets 
Forced ventilation welding helmets 
Gloves, goggles, coverall  
Half  and  full  facemasks  (negative 
pressure respirators) 
Powered air-purifying respirators 
Welding  helmets  with  a  separate  air 
supply 
Restructuring operations/processes 
Redesign of work processes 
Reduced number of workers exposed 
Reduced 
activity 
Rotation of the workers exposed 
Separate  welding  and  associated 
processes  

time  spent  on  welding 

1 

1 

1 
1 

1 

1 
1 

1 
1 
1 

1 
1 

1 

1 
1 

1 
1 

1 

1 
1 

1 
1 

1 
1 

1 

1 

1 

1 

1 
1 

3 
2 

3 

3 
3 

1 
2 
3 

3 
2 

1 
3 

2 

1 
2 

258 

1 
1 

4 
2 

4 

4 
4 

1 
2 
2 
1 
4 
3 

1 
3 

1 
1 

1 

1 

1 

1 

1 
1 

1 

1 

1 

1 

2 
2 

1 
1 

2 
1 

1 
1 

2 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
1 

2 

1 

2 

1 

1 

1 

Substitution or discontinuation 
Substitution  of  welding  or  associated 
processes with other joining processes 
(gluing, folding, screws, rivets) 
Substitution  with  a  lower  emission 
welding+ process 
Ventilation and extraction 
Closed systems 
General ventilation 
Open hoods  
Partially closed systems 
Regular maintenance  
Separate  low  volume  or  high  volume 
spot extraction  
Simple enclosed control cabs 
Welding  booth  with  a  welding  table 
and adjustable extraction element 
Welding  torch-integrated  extraction 
system 
Source: RPA (2024) Stakeholder consultation 2023, 58 responses received. 

2 
3 
2 
1 
2 
1 

1 
1 

1 
1 

1 

1 

1 

1 

2 

1 

1 

1 

2 

1 
3 
3 

2 
1 

1 
2 

1 

1 
1 

1 
2 
1 
1 

1 

Table 116 - RMMs used by the by the Repair and installation of machinery and equipment (C33) 
sector 

RMM 

C33 Equipment repair & installation (3) 

Gas 
fusion 
welding 

MAG 
(flux) 

MAG 
(solid 
wire) 

Not 
specified 

PC  SAW  TIG 

to 

air 
of 
unusual 

Organisational and hygiene measures 
Blood monitoring 
Continuous  measurement 
concentrations 
detect 
exposures 
Creating a culture of safety 
Mask cleaning and filter changing  
Health surveillance  
Regular check of RMM effectiveness  
Training and education  
PPE (Personal Protection Equipment) 
Disposable respirators (FFP masks) 
Face screens, face shields, visors 
Fan-assisted welding helmets 
Forced ventilation welding helmets 
Gloves, goggles, coverall 
Half  and  full  facemasks  (negative 
pressure respirators) 
Powered air-purifying respirators 

1 

1 
1 
1 
1 
1 

1 

1 
1 

1 
1 

1 
1 

1 

1 

1 

1 
1 
1 
1 
1 

1 
1 

1 
1 

1 

259 

1 
1 

1 
1 

1 

1 

1 
1 

2 
2 
2 
1 
2 

1 
1 

1 
2 
2 

2 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
2 

1 

1 
1 
1 
2 

1 

1 

1 

1 

1 

and 

1 
1 
1 

Welding  helmets  with  a  separate  air 
supply 
Restructuring operations/processes 
Permanent  relocation  of  workers  with 
health effects of welding fumes 
Redesign of work processes 
Reduced number of workers exposed 
Reduced time spent on welding activity 
Rotation of the workers exposed 
Separate  welding 
associated 
processes  with  emissions  from  other 
activities in space or time 
Substitution or discontinuation 
Partial  substitution  of  content  base 
material  and  addition  material  such  as 
low manganese materials 
Substitution  of  content  base  material 
and  addition  material  such  as  low 
manganese materials 
Substitution  with 
welding+ process 
Ventilation and extraction 
Closed systems 
General ventilation 
Open  hoods  over  equipment,  tracking 
extraction  elements  or  local  extraction 
ventilation 
Partially closed systems 
Regular maintenance  
Separate  low  volume  or  high  volume 
spot extraction  
Welding  booth  with  a  welding  table 
and adjustable extraction element 
Source: RPA (2024) Stakeholder consultation 2023, 58 responses received 

emission 

lower 

1 
1 

1 

1 

1 

1 

1 

1 

1 

1 
2 
2 

2 
2 

1 

1 

1 

1 
1 
1 

1 

1 
1 

1 

1 

1 

1 

1 

1 

1 

Table 117 - RMMs used by the Repair of fabricated metal products (C33.11), Repair of motor 
vehicles and motorcycles (G45.2) and Education (P85) sectors. 

RMM 

C33.11 
Metal 
products 
repair 
(1) 
TIG 

G45.2 Automotive 
repair (2) 

P85 Education (1) 

MIG 
solder 

MIG/MAG  Brazing  Gas 
fusion 
welding 

MIG/MAG  TIG 

260 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
1 

2 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

of 

and 

and 

1 
1 

face 

check 

1 
1 
1 

screens, 

goggles, 

ventilation 

full 
(negative 

Organisational and hygiene measures 
Blood monitoring 
Culture of safety 
cleaning 
Mask 
filter changing  
Regular 
RMM effectiveness  
Training  and  education 
of workers 
PPE (Personal Protective Equipment) 
Face 
shields, visors 
Forced 
welding helmets 
Gloves, 
coverall 
Half 
facemasks 
pressure respirators) 
Welding  helmets  with 
a separate air supply 
Restructuring operations/processes 
of  work 
Redesign 
processes 
Reduced  number  of 
workers exposed 
Rotation of the workers 
exposed 
Ventilation and extraction 
General ventilation 
Partially 
systems 
Regular  maintenance 
extraction 
of 
equipment 
Welding  booth  with  a 
welding 
and 
extraction 
adjustable 
element 
Welding 
integrated 
system 
Source: Stakeholder consultation 2023, 59 responses received. 

torch-
extraction 

closed 

table 

1 

1 

1 

1 

1 

2 

1 

1 

1 

1 

1 

1 

1 

1 

1 
1 

1 

1 

1 
1 

1 

1 

1 
1 

1 

1 

1 
1 

1 

1 

261 

 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
5.6.  Welding processes, generated substances, indication of CMRs, and workers’ exposure 

Table 118 – Welding processes, generated substances, indication of CMRDs and worker exposure 

 
 
 
263 

 
 
 
 
 
264 

 
 
 
 
5.7.  National regulatory framework 

Table 119 – welding fumes mentioned as process-generated substance in Member States legislation relating 
to the CMRD  

Conclusion 

MS  MSA 
reply
* 
Yes  No mention 

BE 

Confidence  

Medium 

The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I, despite 
Belgium having a specific OEL for welding fumes on 5 mg/m3.  
Annex I of the CMRD is transposed into Annex VI.2-2 of the 2017 Codex on 
wellbeing 
work: 
https://werk.belgie.be/sites/default/files/content/documents/Welzijn  op  het 
werk/Regelgeving/codex2017.pdf  

at 

BG  Yes  No mention 

High 

The MSA says there is no specific legislation for welding fume, other than 
the OEL for Chromium VI.  The relevant document is the Regulation No 10 
of September 26, 2003 on the Protection of Workers from Risks Related to 
Exposure to Carcinogens and Mutagens at work: 
https://www.lex.bg/bg/mobile/ldoc/2135473243  
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  
Annex I of the CMRD is transposed in Appendix 3 of the above Regulation. 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  
Annex  I  of  the  CMRD  is  transposed  into  Appendix  2  of  Government 
Regulation 
https://www.tzb-info.cz/pravni-
Coll: 
predpisy/narizeni-vlady-c-361-2007-sb-kterym-se-stanovi-podminky-
ochrany-zdravi-pri-praci  

361/2007 

No. 

Medium 

CZ 

No 

DK  Yes  Yes, mentioned, process-related limit values for several welding+ 

High 

processes 
Study team interpretation: Denmark effectively defines welding fumes as 
process generated substances because there are process-related limit values 
for several welding+ processes. Also, there is a legal requirement to use a 
ventilation system to remove welding fumes.  Requirements for welding are 
included in the Arbejdstilsynet (the Danish Working Environment 
Authority) guide ‘Welding, cutting, etc. in metal’: https://at.dk/regler/at-
vejledninger/svejsning-skaering-metal-d-2-16/ 
Section C of BEK nr 1054 af 28/06/2022: 
https://www.retsinformation.dk/eli/lta/2022/1054 includes the list of Danish 
process-related limit values for welding processes.  Substance specific limit 
values for metal fumes are included in Section A.  There are many mentions 
of dust, including limit values for metal dusts.   
Annex  I  of  the  CMRD  is  transposed  into  Appendix  2  of  BEK  nr  1795  af 
18/12/2015: https://www.retsinformation.dk/eli/lta/2015/1795. 

DE 

Yes  Yes, mentioned, through OEL for dust and regulations for carcinogens 

High  

in welding fumes 
The study team interpretation of MSA comments and their findings: 
Germany does not specifically define welding fume as a process generated 
substance but effectively it does because of its OEL for dust and the 
extensive regulations (TRGS 528) around carcinogens in welding fumes. 

 
 
 
Annex I of the CMRD is directly transposed in section 2 of TRGS 906:  
https://www.baua.de/DE/Angebote/Regelwerk/TRGS/TRGS-906.html  
The relevant documents are TRGS 906, TRGS 910 which lists carcinogenic 
substances: https://www.baua.de/DE/Angebote/Regelwerk/TRGS/TRGS-
910.html, TRGS 402 which  
covers risk assessments for welding fumes: 
https://www.baua.de/DE/Angebote/Regelwerk/TRGS/TRGS-402.html, 
TRGS 900 providing workplace limit 
values:https://www.baua.de/DE/Angebote/Regelwerk/TRGS/TRGS-
900.html, and TRGS 528: 
https://www.baua.de/DE/Angebote/Regelwerk/TRGS/pdf/TRGS-
528.pdf?__blob=publicationFile&v=1 providing detailed technical rules for 
hazardous substances for welding work specifically. The definition of 
welding fumes according to TRGS 528, Article 2 Definitions is “[fumes] 
from welding work resulting in particulate substances”.  
32 references to the carcinogenicity of aspects of welding fumes or how 
carcinogenicity is taken into account are made in TRGS 528, so the 
carcinogenic nature of welding fumes is definitely recognised in Germany. 
However, exposure to welding fumes is regulated in a risk-based way, rather 
than a blanket regulation of all welding fumes. 
Figure 1 illustrates the fact that the size of particles in fumes depends upon 
the  process.  The  processes  included  in  this  diagram  include  welding, 
soldering, thermal cutting and gouging. 
No mention 
Study team interpretation: there is no definition of welding fumes as process 
generated substances or carcinogen or equivalent in Annex I.  The relevant 
document is the 2021: Occupational health and safety requirements for the 
use of hazardous chemicals and materials containing them and limit values 
for chemical hazards in the working environment, Number 105 of 15 
December 2005, revised 21 December 2021: 
https://www.riigiteataja.ee/akt/121122022014.  At the end of this document 
is a link to the Annex containing the current list of limit values 
https://www.riigiteataja.ee/aktilisa/1211/2202/2014/VV_132m_lisa.pdf   
Annex  I  of  the  CMRD:  the  study  team  is  unable  to  establish  where  this  is 
transposed into Estonian legislation.  However, there is a guide written in for 
the  strategy  2007  –  2015  called  CANCER  RISKS  IN  THE  WORKING 
ENVIRONMENT Prevention of cancer risks in the work environment and a 
general guide to reduction, which contains elements of Annex I of the CMRD 
in paragraph 3.  This includes in item 3 “soldering, welding or other thermal 
processing of materials containing copper and nickel, during which the dust 
and 
aerosol” 
https://www.terviseamet.ee/sites/default/files/content-
editor/vanaveeb/Tervishoid/tootervis/Vahiriskid_tookeskkonnas_eesti.k.pdf  
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant document is the Irish 2021 Code of Practice for the Safety, Health 
and Welfare at Work (Chemical Agents) Regulations (2001-2021) and the 
Safety, Health and Welfare at Work (Carcinogens) Regulations (2001-2019: 

these  metals 

produced 

smoke 

are 

of 

or 

266 

Medium 

High 

EE 

No 

IE 

No 

 
 
 
 
https://www.hsa.ie/eng/publications_and_forms/publications/chemical_and_
hazardous_substances/2021-code-of-practice-for-the-chemical-agents-and-
carcinogens-regulations.pdf  
There are substance specific limit values for metal fumes and metal dusts 
that may be relevant to welding. 
Annex 1 of the CMRD is transposed in Schedule 4 of the 2021 Code of 
Practice. 

EL 

No 

Low 

Unclear 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I (but it 
is hard to be sure.) 
The Government Gazette 50A 2020 
https://elinyae.gr/sites/default/files/2020-03/50a_2020.pdf harmonises 
Greek legislation with the CMRD, and exposure limit values for chemical & 
biological agents 2019 (Greek legislation)  
https://www.elinyae.gr/sites/default/files/2019-
10/oriakes%20times%202019_L_0.pdf is an older version of similar 
legislation, with many terms in English.  Both documents are difficult to 
search, either because some or all of the documents cannot be searched, or 
because some or all of the documents cannot be copied. 
Annex  I  of  the  CMRD  is  directly  transposed  on  page  2  of  the  Government 
Gazette 50A 2020 and does not mention welding. 

ES 

Yes  No mention 

High 

FR 

No 

The MSA says there is no specific legislation for welding fumes and no 
definition of welding fume as a process generated substance. 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant document is the Royal Decree 665/1997, of May 12, 1997, on the 
protection of workers against risks related to exposure to carcinogens at 
work  BOE-A-1997-11145 Royal Decree 665/1997 of 12 May <> on the 
protection of workers against the risks related to exposure to carcinogens at 
work. 
Annex  I  of  the  CMRD  is  partly  transposed  in  Annex  I  of  the  above  Royal 
Decree 665/1997 of 12 May 1997. 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  
There are non-specific generic dust limits (for inhalable and respirable dust 
respectively) which apply to welding fumes, but the study team was unable 
to find any mention of welding relating to generic dust.  
Annex I of the CMRD was transposed in Article 1 of the Order of October 
26, 2020 establishing the list of carcinogenic substances, mixtures and 
processes within the meaning of the labour code, (Version in force since 
July 1, 2021, Article 1 was modified by an Order dated 3 May 2021): 
https://www.legifrance.gouv.fr/loda/article_lc/LEGIARTI000043483855/20
21-07-01 A brochure on how to use OELs, called ’Methods of prevention: 

267 

Medium 

 
 
 
 
 
 
 
measurement and evaluation devices’: 
https://www.inrs.fr/dms/inrs/CataloguePapier/ED/TI-ED-6443/ed6443.pdf  
contains no reference to welding, or welding fumes, and only 2 references to 
fumes (fumées) in relation to the definition of an aerosol, and the definition 
of fumes.  
The definition of fumes is given as: ”dispersions in the air of very fine solid 
particles, possibly accompanied by gases and vapours, generated by thermal 
processes,  either  by  condensation  from 
the  gas  phase  (sometimes 
accompanied  by  chemical  reactions  such  as  oxidation),  or  by  incomplete 
combustion”. 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I. The 
relevant documents are the original bylaw from 2018 on the protection of 
workers against exposure to dangerous chemicals at work, exposure limit 
values and biological limit value: https://narodne-
novine.nn.hr/clanci/sluzbeni/2018_10_91_1774.html and updates to the 
2018 bylaw are in this bylaw https://narodne-
novine.nn.hr/clanci/sluzbeni/2021_01_1_10.html 
The transposition of Annex I is done as a separate update with each by-law 
only listing the updates  to the  original  by-law.  The  list  of  substances in  the 
Annex I of the CMRD do not appear to be listed together in one place. 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant document is the Legislative Decree no. 9 of 2008 April 81 amended 
November 2023 includes the transposition of the CMRD. 
https://www.ispettorato.gov.it/files/2023/11/TU-81-08-Ed.-Novembre-
2023.pdf 
Annex  XLII  of  the  above  covers  Annex  1  on  page  157  and  there  is  no 
mention of welding.  
Unclear 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant document is the Safety and Health at work laws of 1996 to (No. 2) 
of 2015: 
https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/all/D74ACEE6A814B7EAC225
7E03002A76C9/$file/KDP_282-2020.pdf 
According  to  the  MSA  response  for  the  main  consultation,  Cyprus  has  an 
OEL  for  welding  fumes.   But  the study  team  cannot  find  this.    Neither  can 
any documents be found that mention items from Annex I of the CMRD.  All 
documents are difficult to search, either because they cannot be searched, or 
they cannot be copied. 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant document is Regulations of the Cabinet of Ministers No. 325: 
https://likumi.lv/doc.php?id=157382&from=off on the Labor protection 
requirements in contact with chemical substances in workplaces. 

268 

Medium 

Medium 

Low 

Medium 

HR  No 

IT 

No 

CY  No 

LV 

No 

 
 
 
 
Annex I of the CMRD is transposed into Annex 2 of the Cabinet of Ministers 
Regulations  No.  803  of  September  29,  2008:  https://likumi.lv/ta/id/181871-
darba-aizsardzibas-prasibas-saskaroties-ar-kancerogenam-vielam-darba-
vietas 

LT 

Yes  Yes, mentioned, OEL for welding aerosols 

High 

Study team interpretation: the definition of welding aerosol provided by the 
MSA implies that aerosol is process generated and the toxicity of the 
substances present (with associated limit values) in the aerosol will depend 
upon the materials being welded and welding process being used.  This 
provision was established before Lithuania joined the EU (not as a 
transposition of CMRD) 
The study team found that in Order HN 23:2011 https://www.e-
tar.lt/portal/lt/legalAct/TAR.8012ED3EA143/asr on Lithuanian Hygiene 
Standards Occupational Exposure Limits for Chemicals., item 692 of Annex 
1 of the Lithuanian Hygiene Standard HN 23:2011 referenced by the MSA 
was provides the definition and an OEL for welding aerosols.  There is no 
other reference to welding fumes.  The translation of the definition of 
welding aerosol is “the entire respirable fraction of a suspension of solid, 
liquid or solid and liquid particles in a gaseous medium. Depending on 
the composition of the welding alloy, the electrodes used and the welding 
process, ozone may be released into the environment (e.g. when welding 
aluminium, titanium and their alloys with an electric arc in a protective 
argon atmosphere), carbon monoxide (e.g. when welding alloy steel with an 
electric arc), metals (iron, manganese, chromium, nickel), fluorides (flux-
coated and hollow electrodes are prepared with fluorides). Therefore, first of 
all, it is necessary to determine whether the individual limit values of the 
aerosol components are not exceeded. If there are no toxic substances in the 
welding electrode, the metal to be welded or its coating, and no toxic gases 
are formed during welding, it is sufficient to determine the total 
concentration of the welding aerosol.” 
Annex 
https://www.e-
is 
tar.lt/portal/lt/legalAct/TAR.313208361D5D  under  Section  VII  Final 
provisions.   
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant documents are Regulation 37 of the 30 January 2020: 
http://legilux.public.lu/eli/etat/leg/rgd/2020/01/24/a37/jo and Regulation 
684 of the 16 August 2018: 
http://legilux.public.lu/eli/etat/leg/rgd/2018/07/20/a684/jo 
Annex  I  of  the  CMRD  is  transposed  into  Annex  1  of  the  Grand-ducal 
regulation  of  November  14,  2016  concerning  the  protection  of  employees 
against  the  risks  linked  to  exposure  to  carcinogens  or  mutagens  at  work: 
https://legilux.public.lu/eli/etat/leg/rgd/2016/11/14/n3/jo 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant document is the ITM decree on the protection of the health and 
safety of workers exposed to chemical pathogenic factors, 5/2020 (II.6): 

the  CMRD 

transposed 

of 

in 

1 

269 

Medium 

Medium 

LU 

No 

HU  No 

 
 
 
 
MT  No 

NL 

No 

AT 

No 

(IX 

26/2000 

https://net.jogtar.hu/jogszabaly?docid=a2000005.itm 
Annex  I  of  the  CMRD  is  transposed  in  EüM  decree  on  protection  against 
occupational  carcinogens  and  the  prevention  of  health  damage  caused  by 
them, 
30): 
https://net.jogtar.hu/jogszabaly?docid=a0000026.eum,  with  no  item  relating 
to welding. 
Unclear 
The study team was unable to find any mention of welding fumes, despite 
undertaking extensive searches but there may be other legislation which was 
not identified. 
The relevant documents were in a database of Maltese legislation 
https://legislation.mt/. The Maltese Legal Notice (LN) 227 of 2003 
https://legislation.mt/eli/sl/424.24/eng/pdf , which contains the OELs, has 
since been amended by LN 198 of 2015, LN 57 of 2018 and LN 356 of 
2021: these three Legal Notices were also searched. 
Annex  I  of  the  CMRD:  the  study  team  is  unable  to  establish  where  this  is 
transposed into Maltese legislation.  
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant documents were “SZW list of carcinogenic substances and 
processes, mutagenic or for reproduction toxic substances, Ministry of 
Social Affairs and Employment” published on 3 January 2022 in the 
Government Gazette of the Kingdom of the Netherlands: 
https://zoek.officielebekendmakingen.nl/stcrt-2022-51.html 
The Netherlands Working Conditions Regulations 
(https://wetten.overheid.nl/BWBR0008587/2022-07-01#BijlageXIII) 
contain the generic dust limit value for welding fume for the Netherlands, 
but no other references to welding fume, welding and no reference to 
welding as a process generated substance. 
Annex I of the CMRD is transposed into a list of carcinogenic substances and 
processes which was published in Gazette entry mentioned above published 
on 3 January 2022. 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant document is the Austrian Order Grenzwerteverordnung 2021 - 
GVK 
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&
Gesetzesnummer=20001418 
Annex  I  of  the  CMRD  seems  to  have  been  transposed  on  a  state-by-state 
basis.  For  example,  in  the  Styrian  state  (second  largest  state  in  Austria) 
Annex I is transposed in the State law gazette, dated 13 October 2005, p414: 
https://www.ris.bka.gv.at/Dokumente/Lgbl/LGBL_ST_20051013_100/LGBL
_ST_20051013_100.pdf  

Low 

Medium 

Medium 

PL 

Yes  No mention 

High  

MSA says there is no definition of welding fumes as a process generated 
substance.  The study team cannot find any definition of welding fumes 
specifically as a process generated substance, as carcinogen or equivalent 

270 

 
 
 
 
PT 

No 

and to Annex I.  The relevant documents are the list of limit values of 12 
June 2018:https://sip.lex.pl/akty-prawne/dzu-dziennik-ustaw/najwyzsze-
dopuszczalne-stezenia-i-natezenia-czynnikow-szkodliwych-dla-18733965 
and 3 December 2021, Poz. 2235 
https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20210002235/O/D2021
2235.pdf 
Annex 1 of the CMRD is transposed on page 6 of Poz. 2235 the regulation 
on chemical substances. 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant documents are the Decree-Law number 24/2012 of the 6 February 
2012:  https://dre.pt/dre/legislacao-consolidada/decreto-lei/2012-115495237 
which lists limit values. 
Annex I of the CMRD is transposed into Article 3 of Decree-Law No. 
35/2020, of July 13 2020: https://diariodarepublica.pt/dr/detalhe/decreto-
lei/35-2020-137703603  

Medium 

RO  Yes   No mention 

High  

SI 

No 

MSA says there is no specific legislation for welding fume. 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant document is the Decision no 1093 of August 16,2006 regarding 
establishment of minimum safety and health requirements for the protection 
of workers against the risks related to exposure to carcinogenic or 
mutagenic agents at work 
https://legislatie.just.ro/Public/DetaliiDocument/74889.  This document 
does not contain any reference to “welding” or “weld”.  Annex I of the 
CMRD: Annex 1 of the CMRD is transposed in Appendix 1 of the above 
Decision 1093/2006. 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant source is “Rules on the protection of workers from risks related to 
chemical exposure at work” Official Gazette of the Republic of Slovenia 
No. 72/21, from the Minister of Labour, Family and Social Affairs and 
equal opportunities (2021): 
http://www.pisrs.si/Pis.web/pregledPredpisa?id=PRAV14252#.   
Annex I of the CMRD is transposed on page 26 of  Practical guidelines for 
limit values for hazardous chemical substances, :  
https://vzd.mddsz.gov.si/document-download/prakticne-smernice-za-mejne-
vrednosti-za-nevarne-kemicne-snovi-2022-01-14-429. 

Medium 

SK 

Yes  Yes, mentioned, OEL for welding solid aerosols 

High 

MSA indicates that there is specific legislation for welding fumes, with an 
OEL.  Welding solid aerosols have an OEL of 5mg/m3.  The relevant 
documents are the Slovak regulation 355/2006 or “Temporary version of the 
Regulation protecting the health of employees from risks related to exposure 
to carcinogenic and mutagenic factors at work, of 10 May 2006, effective 
from 01.10.2020”: https://www.slov-lex.sk/pravne-
predpisy/SK/ZZ/2006/356/ 

271 

 
 
 
 
Annex 1 of the CMRD is directly transposed in Annex 1 of the above 
regulation. 

FI 

Yes  Yes, mentioned, already in transposition of Annex 1 of the CMRD 

High 

SE 

No 

Medium 

MSA says, and study team confirms, that welding and thermal cutting of 
stainless steel has already been added to the Finnish equivalent of Annex I 
of the CMRD.  The decree is the following: 
https://www.finlex.fi/fi/laki/alkup/2019/20191267  on page 4 is Annex I, in 
Finnish “Liite I”, which includes carcinogenic work processes. Annex I 
includes: “10. Ruostumattoman teräksen hitsaus ja polttoleikkaus.” This 
translates to: “Welding and thermal cutting of stainless steel”. 
The relevant document is the Decree of the Government addressing the risk 
of work-related cancer, 1267/2019, of 12 December 2019: 
https://www.finlex.fi/fi/laki/alkup/2019/20191267 
No mention 
The study team cannot find any definition of welding fumes specifically as a 
process generated substance, as carcinogen or equivalent to Annex I.  The 
relevant document is 2018:1 The Swedish Work Environment Authority's 
regulations and general advice on hygiene limit values in relation to the 
inhalable and respirable fractions of welding fume particles: 
https://www.av.se/arbetsmiljoarbete-och-
inspektioner/publikationer/foreskrifter/hygieniska-gransvarden-afs-20181-
foreskrifter/  
This legislation contains many dust limit values for different substances, but 
not welding specifically. There is advice on the measurement of workplace 
dust and references to Swedish standards and a Swedish OSH method. 
Annex I of the CMRD is transposed into the Swedish Provisions and 
General Recommendations on Chemical Hazards in the Working 
Environment (AFS 2011:19, p21): 
https://www.av.se/globalassets/filer/publikationer/foreskrifter/engelska/che
mical-hazards-in-the-working-environment-provisions-afs2011-19.pdf and 
amended by general advice on chemical work environment risks (AFS 
2022:4) 
https://www.av.se/globalassets/filer/publikationer/foreskrifter/andringsfores
krift/afs-2022-4.pdf  

ANNEX 7: ROUTE(S) OF EXPOSURE AND ADVERSE HEALTH EFFECTS 

1.  COBALT AND ITS INORGANIC COMPOUNDS  

1.1.  Routes of exposure and uptake 

Relevant exposure routes are oral and inhalation. Inhalation absorption is highly dependent on the 
particle size of cobalt. As a metal cobalt is not metabolised in the body. Excretion after inhalation 
exposure  is  highly  dependent  on  the  solubility  of  the  cobalt  substance,  the  more  soluble  the 
substance is, the more rapidly it is eliminated via the lungs by transfer to the blood and excretion 
via urine and faeces. 

272 

 
 
 
 
 
1.2.  Adverse health effects 

Cobalt  and  several 
inorganic  cobalt  compounds  have  a  harmonised  classification  for 
carcinogenicity according to Annex VI of the CLP Regulation (Canc. 1A or B). Numerous studies 
on carcinogenic effects of cobalt have been published. However, the epidemiological evidence can 
be considered  as inconsistent  mainly  due to  the presence of confounding  factors or limitations of 
the studies. Experimental evidence of alveolar/bronchiolar adenomas and carcinomas (combined) in 
the lung of rodents was found in two chronic inhalation NTP studies with soluble cobalt sulphate 
heptahydrate  and  non-soluble  cobalt  metal.  RAC  considers  carcinogenicity  in  animal  studies  and 
non-cancer  related  respiratory  effects  in  exposed  workers  as  the  critical  toxicological  endpoints 
after cobalt exposure. For carcinogenicity they did not identify a threshold. However, RAC believes 
that a ‘break point’ for the carcinogenic effects can be established at 0.5 µg/m³ and derived an ERR 
for lung cancer (RAC, 2022). This ERR is also applied in the present report. 

The main critical non-cancer endpoints after inhalation exposure are respiratory effects observed in 
exposed workers.  

RAC  considers  three  occupational  exposure  settings  in  the  context  of  the  OEL  derivation.  These 
are:  

•  production and use of cobalt and cobalt compounds;  
•  production and use of hard-metal; and  
•  polishing of diamonds.  

According to RAC exposure to cobalt is associated with diseases like asthma, whereas exposure to 
cobalt-containing  hard-metal  is  an  established  cause  of  parenchymal  lung  disease.  Parenchymal 
lung  disease  is  also  reported  in  workers  from  the  diamond-polishing  industry.  Numerous  studies 
from different industrial sectors describe decreased lung function and respiratory tract irritation in 
association with cobalt exposure. 

Cobalt  metal  and  several  cobalt  compounds  also  have  a  harmonised  classification  as  Repr.  1B 
(H360F)  or  are  notified  by  the  registrants  as  Repr.  1B  (H360)  or  Repr.  1A  (H360)  as  significant 
effects on the male reproductive system can be observed. These classifications are based on animal 
data  (e.g.  reduced  sperm  motility)  as  no  relevant  epidemiological  data  are  available  investigation 
fertility or developmental toxicity effects.  

Effects mainly observed after oral cobalt exposure or in non-occupational settings (cardiovascular 
diseases,  thyroid-related,  haematological  and  nervous/sensory  effects)  are  not  considered  for  the 
current assessment.  

2.  PAHS  

2.1.  Routes of exposure and uptake  

Inhalation  is  the  most  relevant  exposure  pathway  for  PAH  for  workers.  However,  also  dermal 
exposure both with regard to local tumorigenesis (PAH mixtures cause skin tumours after dermal 

273 

 
 
 
 
exposure,  see  below)  and  systemic  uptake  is  relevant.  For  the  dermal  exposure  route  absorption 
rates widely differ, depending on PAH components and model species. BaP is readily absorbed via 
inhalation, the oral and dermal route. 

PAH are rapidly distributed via blood and lymph in the whole body. Biotransformation takes place 
predominantly  via  oxidative  pathways  by  CYP  enzymes  (CYP1A1  and  A2)  in  the  liver.  Initially 
formed epoxides are converted to  dihydrodiol derivatives and phenols.  Induction of the oxidative 
metabolising enzymes occurs via binding to the aryl hydrocarbon receptor AhR.  

Glucuronide  and  sulphate  conjugates  of  PAH  metabolites  are  excreted  in  the  bile  and  urine. 
Glutathione conjugates are further metabolized to mercapturic acids in the kidney and are excreted 
in the urine. A commonly measured urinary metabolite is 1-hydroxypyrene. Renal PAH elimination 
was reported with  a half-life range between 6 to 35 hours after occupational  exposure. Excretion 
half-lives  in  faeces  and  urine  have  been  reported  in  animal  studies  as  22  hours  and  28  hours, 
respectively. 

2.2.  Adverse health effects 

The most important health effect of PAH is carcinogenicity, most prominently lung cancer but also 
in  the bladder, and skin. The  International  Agency for Research on Cancer  (IARC)  classified the 
substance  benzo[a]pyrene  (BaP)  and  certain  occupational  activities  (e.g.  coal  tar  distillation)  as 
carcinogenic to humans (group 1). Also, there is sufficient evidence for the carcinogenicity of BaP 
and some other PAH in experimental animal studies. 

PAH show moderate to low systemic toxicity after short- or long-term exposure. The most relevant 
non-cancer  endpoint  of  PAH  is  reproductive  toxicity,  which  has  been  shown  for  BaP  in  several 
animal studies. 

3.  1,4-DIOXANE   

3.1.  Routes of exposure and toxicokinetics  

As reported in the REACH dossiers the occupational exposure is expected to  occur via inhalation 
during production, processing and use of the substance224. The dermal route also contributes to the 
body  burden  (no  quantification  available;  ECHA,  2022b).  Adsorption  after  inhalation  and  oral 
exposure  is  rapid.  Newer  data  (Dennerlein  et  al.  2015;  RAC  2022a)  also  point  to  considerable 
adsorption  after  dermal  exposure.  Once  absorbed  1,4-dioxane  is  evenly  distributed  and  rapidly 
metabolised  (CYP  mediated)  to  HEAA  (and  1,4-dioxane-2-one,  which  is  in  pH-dependent 
equilibrium  with  HEAA).  Excretion  takes  place  mostly  in  urine  as  HEAA  (minor  amount 
unchanged), but also to some degree in exhaled air (unchanged or CO2). 

224 Estimates range from 0.03 mg/m³ up to around 26 mg/m³ 

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3.2.  Adverse health effects   

The substance is irritating to the eyes and respiratory tract and due to its defatting properties causes 
skin dryness and eventually skin cracking. The substance is not known to be a skin sensitiser from 
animal experiments and does not show reproductive and/or developmental toxic effects in available 
studies on rats and mice. The main target organs are the respiratory tract  (e.g. nasal  cavity), liver 
and  kidney,  especially  after  repeated  exposure  (ECHA,  2022b).  With  regard  to  carcinogenicity, 
there is only limited evidence from human epidemiological studies. However, based on results from 
experimental  animal  data  1,4-dioxane  is  considered  carcinogenic  in  rodents,  thus  leading  to 
harmonised classification as Carc. 1B (ECHA, 2022a).  

4. 

ISOPRENE   

4.1.  Routes of exposure and toxicokinetics  

Occupational exposure to isoprene may occur primarily via inhalation or dermal contact during the 
production and usage of isoprene or synthetic rubber at industrial sites (RAC, 2022a). The dermal 
uptake is regarded as negligible (RAC, 2022b). However, isoprene can also be found in the air as it 
is produced and emitted by vegetation (RAC, 2022a). Isoprene is endogenously formed in humans 
with an estimated rate of approx. 0.2 µmol/kg bw and necessary for the synthesis of steroids and 
terpenes (RAC, 2022a). 

It is mainly in the liver (90%) that isoprene is metabolised to monoepoxides which can be further 
oxidised to a diepoxide. This diepoxide is mutagenic. Subsequently, isoprene epoxides are broken 
down  and  conjugated  by  enzymes  which  results  in  a  loss  of  toxicity  (Hartwig  and  MAK 
Commission, 2015, RAC, 2022a). Studies observed interspecies differences in enzyme activity and 
its effects on the formation of the toxic isoprene metabolite. It was observed that especially mice 
and  rats  are  more  susceptible  to  isoprene  and  its  metabolism  to  the  mutagenic  diepoxide  than 
humans (Peter et al., 1990; RAC, 2022a). 

4.2.  Adverse health effects  

Isoprene has a harmonised classification for carcinogenicity (Carc. 1B) and mutagenicity (Muta. 2). 
There  are  no  epidemiological  studies  on  exposure  to  isoprene  alone.  However,  a  small  database 
exists for rubber industry workers exposed to isoprene and other chemicals at the same time. There 
is  sufficient  evidence  for  the  carcinogenic  activity  of  isoprene  from  experimental  animal  studies. 
RAC considered the carcinogenicity of isoprene “[…] as the critical health effect.” (RAC, 2022a). 

The considerations in the RAC opinion report identified the increase in the number of cells in the 
spleen and increased cell growth of haemopietic cells in bone marrow as the most sensitive toxicity 
endpoints  from  chronic  exposure.    For  these  endpoints  the  Lowest  Observed  Adverse  Effect 
Concentration (LOAEC) was 10 ppm (28 mg/m3). 

Additionally,  repeated  exposure  to  isoprene  has  been  found  to  cause  adverse  effects  on  several 
organ systems. Based on these adverse effects, the following endpoints were evaluated:  

275 

 
 
 
 
•  Anaemia;  
•  Degeneration of olfactory epithelium;  
•  Degeneration of spinal cord white matter;  
•  Male fertility; 
•  and reduced birthweight. 

5.  WELDING FUMES 

5.1.  Routes of exposure and uptake   

During  welding,  metal  pieces  are  fused  through  coalescence  by  using  heat  (energy)  and  filler 
material (also containing metals).  During the heating process metals vaporise and condense rapidly 
afterwards into  fine particles (particulate matter/fumes).   Depending on the base metals,  the used 
filler material, and the heat source the composition of the fumes can vary widely.  In addition to the 
particulate matter (welding fumes), gases such as carbon monoxide are present  and might  impact 
observed  health  effects.    Inhalation  is  the  most  important  route  of  exposure.    Process-generated 
fumes  from  welding  and  similar  processes  ((soldering,  thermal  cutting  or  gouging,  thermal 
spraying, flame straightening, additive production processes) are summarised by ECHA (2022) as 
welding fumes+. 

5.2.  Adverse health effects  

A critical health effect is carcinogenicity. IARC (2018) concluded that there is sufficient evidence 
for  increased  lung  cancer  risks  in  humans  due  to  exposure  to  welding  fumes.  Also,  a  weaker 
association was observed with kidney tumours. 

Apart  from  carcinogenicity,  welding  fumes  may  cause  several  types  of  respiratory  tract  toxicity, 
after short-term as well as long-term exposure.  Acute effects comprise acute irritation to the throat 
and  larger  airways  in  the  lungs.  Metal  fumes  fever  is  a  (transient)  flu-like  condition.    Further, 
welders show a higher risk to develop acute pneumonia (pneumococcal pneumonia).   

Chronic  effects  consist  of  occupational  asthma,  chronic  bronchitis  (airway  inflammation,  with 
symptoms like coughing and mucus in the bronchiolar airways) and welder’s lung (also known as 
siderosis). Welder’s lung  is  an  iron-particle induced benign  pneumoconiosis, which is  unlikely to 
proceed to interstitial fibrosis.  It is characterised by deposition of metal particles in the lung, with 
no clear correlation to a decrease in lung function.  The evidence for welding fumes deteriorating 
lung  function  and  causing  chronic  obstructive  pulmonary  disease  (COPD)  is  discussed,  but  the 
evidence so far is weak.   

In  addition  to  the  respiratory  effects,  it  is  discussed  that  welding  fumes  exposure  may  lead  to 
neurological  disorders,  possibly  caused  by  manganese  and  nephrotoxicity  (tubular  dysfunction), 
due  to  the  presence  of  cadmium  in  welding  fumes.    Further,  reproductive  toxicity  caused  by 
welding fumes is under discussion.   

276 

 
 
 
 
 
ANNEX 8: PROCESS FOR SETTING BINDING LIMIT VALUES AND 
ASSOCIATED PROVISIONS UNDER THE CMRD 

Step 1: priority setting  

It is not realistic to address every hazardous chemicals that may be used at the workplace. Instead it 
is appropriate to identify and target priority substances.  

The selection of the substances to be addressed through this initiative was based on a consultative 
approach including stakeholder engagement at Member States and social partners levels, and taking 
into account general considerations such as the following:  

•  Potential to cause adverse health effects resulting from occupational exposure;  
•  Processes  resulting  in  exposure  or  combined  exposures  to  chemicals  with  the  potential  to 
cause adverse health effects  resulting from  a work activity for which markers of exposure 
are needed; 

•  Emerging specific issues on a basis of reported evidence and expert judgment.  
•  Degree of evidence for adverse effects; 
•  Characteristics of the adverse effects (severity, potency, reversibility, specificity).  
•  Estimated number of workers exposed; 
• 
•  Policy  considerations,  such  as  problematic  disparities  with  or  between  other  relevant 
threshold values, degree of stakeholders' interest in having an EU OEL, or other institutional 
priorities; 

Identified exposure patterns that pose difficulties for the control of exposures;  

Considering  the  ill-health  work-related  burden,  it  is  important  to  note  that  when  identifying  a 
priority  substance,  stakeholders  look  at  the  whole  range  of  potential  negative  health  effects 
(carcinogenic and non-carcinogenic) which could be prevented by establishing an EU level OEL or 
other measures.  

The Commission is committed to continuing efforts to strengthen the application of such criteria in 
the future.  

Step 2: scientific evaluation and public consultation  

Article  16  of  the  CMRD  state  that  scientific/feasibility  data  should  be  included  in  the  basis  on 
which binding OELs and BLVs are set, but the directives do not determine which scientific body 
should be the source of such data. However, based on a Service Level Agreement (SLA) signed by 
DG  EMPL  and  ECHA,  this  Committee  assists  the  Commission  delivering  scientific  evaluations, 
upon request, on the toxicological profiles of each of the selected priority chemical substances in 
relation  to  their  adverse  health  effects  on  workers.  These  scientific  evaluations  shall,  where 
appropriate,  include  proposals  for  Occupational  Exposure  Limit  values  (OELs),  biological  limit 
values  (BLVs)/biological  guidance  values  and/or  notations.  This  task  shall  be  carried  out  on  the 

277 

 
 
 
 
 
basis of the latest available scientific and technical data and take into account the specific context 
of occupational exposures at the workplace.  

Scientific  information  from  other  sources  can  also  be  taken  into  account  as  long  as  the  data  is 
adequately  robust  and  is  in  the  public  domain  (e.g.  conclusions  of  national  limit  vlaue-setting 
science committees). RAC carries out scientific evaluation at EU level based on the methodology 
agreed  withing  the  ECHA/RAC-SCOEL  Joint  Task  Force  and  as  a  result  publish  an  Opinion  on 
scientific evaluation of occupational exposure limits for the selected priority chemical substances. 
RAC  procedure  for  the  adoption  of  an  Opinion  includes  an  external  consultation  of  relevant 
stakeholders. This ensures scrutiny of the scientifc evidence and methodological approach used by 
RAC and ensures transparency of the process.  

Step 3. Two-stage social partner consultation 

TFEU  Article  154  requires  a  formal  two-stage  consultation  of  the  social  partners  at  EU  level 
(management  and  labour)  prior  to  submitting  proposals  in  the  social  policy  field.  As  regards  the 
present initiative, this consultation took place in 2023. Annex 2 provides further information on the 
outcomes of the consultation. 

Step 4:  Tripartite consultation of Member States and social partners 

While the aim of ensuring the protection of the health of workers is maintained, binding OELs set 
under CMRD must also reflect other factors such as 'feasibility' and take into account the views of 
the social partners. For this reason the Opinion of the ACSH is requested. 

The ACSH is a tripartite body set up in 2003 by a Council Decision (2003/C 218/01) to streamline 
the  consultation  process  in  the  field  of  occupational  safety  and  health  and  rationalise  the  bodies 
created in this area by previous Council Decisions. The ACSH remit is to assist the Commission in 
the  preparation,  implementation  and  evaluation  of  activities  in  the  fields  of  safety  and  health  at 
work.  The  ACSH  is  composed  of  three  full  members  per  Member  State,  representing  national 
governments,  trade  unions  and  employers'  organisations,  also  organised  in  three  separate  interest 
groups within the Committee. 

The  ACSH  is  supported  by  working  parties  of  experts  on  given  topics  of  interest  according  to 
mandates  agreed  by  the  plenary  Committee.  These  working  parties  are  also  tripartite  but  usually 
with smaller selected expert membership. 

The ACSH Working Party on Chemicals (WPC) undertakes broader chemicals policy support for 
the ACSH and Commission and in particular detailed technical and policy negotiation of EU limit 
values.  This  process  is  informed  by  all  available  evidence  regarding  appropriate  and  achievable 
limit values including adopted RAC Opinions and any national OELs.  

It is during these, often complex, discussions that the level of ambition which is appropriate for a 
specific EU limit value (OEL, STEL or BLV) for a substance is established, taking into account the 
views of representatives from the government, workers’, and employers’ interest groups. 

278 

 
 
 
 
The  ACSH  discusses  adopted  RAC  Opinions  (and/or  other  appropriate  scientific  evidence)  and 
adopts a formal Opinion. 

The adopted ACSH Opinions include, where necessary, specific comments from the interest groups 
(government,  employers  and  workers)  which  broadly  reflect  the  principal  points  maintained  by 
each interest group throughout discussions of the Working Party on Chemicals (WPC).  

The ACSH has adopted opinions for the priority substances foreseen for this amendment of CMRD. 

In practice, a limit value emerging from this process reflects a deep technical, socioeconomic, and 
political  consideration  of  what  is  achievable  by  employers  across  the  EU  and  also  ensures  that 
workers' health is  adequately protected. These Opinions are also  adopted taking into account  that 
the limit values exist within the broader context of the CMRD general obligations to prevent risks 
to  workers’  health  (exposure  elimination/reduction,  process  enclosure  etc.),  which  establishes  an 
appropriate and exceptionally high legal standard for workplace- and process-specific risk control. 

Step 5:  Impact assessment 

Between  2022  and  2024,  an  external  contractor  evaluated,  on  behalf  of  the  Commission,  health, 
socioeconomic  and  environmental  impacts  of  the  proposed  amendments  to  CMRD  in  order  to 
perform an impact assessment according to the regulatory procedures in place.  

The  impact  assessment  takes  all  of  the  above  steps  into  consideration  and  the  IA  Report  is 
presented to  the Commission services Regulatory Scrutiny Board in  accordance with  the relevant 
internal rules for initiatives with foreseeable significant impacts. 

The  options  for  action  proposed  by  the  ACSH  are  established  through  a  thorough  scientific, 
technical  and  socioeconomic  discussion  and  in  general  the  tripartite  agreements  reached  in  the 
Advisory  Committee  would  be  put  forward  in  the  eventual  Commission's  proposal.  However,  in 
line with the Better Regulation guidelines, an IA is conducted before presenting the proposal. In the 
IA the Commission verifies the ACSH opinions on the basis of a dedicated study. 

As a result of the IA the ACSH-based options could be withheld, retained or complemented. 

A proposed action is withheld if the ACSH opinion has not been sufficiently consensual, and the 
Commission's assessment leads to concerns about the proposal (e.g., as regards legality or clarity). 
This does not mean that the Commission discards the option. Rather, important additional elements 
are needed before further assessing the option.   

An  option  is  retained  if  the  ACSH  opinion  has  been  clear  and  consensual,  there  are  no  concerns 
about  the  legality  and  clarity  of  the  option  and  the  socioeconomic  assessment  confirms  the 
robustness of ACSH opinions in terms of effectiveness, efficiency and coherence. 

An  option  may  be  further  complemented  if  the  ACSH  opinion  did  not  take  into  account  an 
important scientific element, such as the need to establish a skin notation. 

279 

 
 
 
 
A positive opinion of the RSB is a prerequisite before presenting the draft proposal for adoption by 
the college of Commissioners. 

After  completion  of  these  steps,  the  Commission  prepares  the  legislative  proposal  which  will  be 
adopted  following  the  ordinary  legislative  procedure.  The  adopted  Directive  will  be  published  in 
the EU Official Journal and Member States will then transpose the limit values and any associated 
notation into their national legislation by the date set in the Directive. 

The limit values adopted will then ensure a consistent level of minimum protection for all workers 
in  the  EU,  while  leaving  the  Member  States  the  option  of  keeping  or  setting  more  favourable 
standards by introducing more stringent limit values.  

Within  the  CMRD  there  are  obligations  for  employers  to  apply  the  appropriate  measures  at  the 
workplace to ensure that the exposure of workers to these substances do not exceed the limit values. 
The  monitoring  of  the  correct  implementation  of  the  national  legislation  that  transposes  the  EU 
directives  and  enforcement  will  be  undertaken  by  national  authorities,  in  particular  the  national 
labour inspectorates. 

280 

 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 9: DATA SUPPORTING THE SETTING OF POLICY OPTIONS  

1.  Cobalt and inorganic cobalt compounds 

The  policy  options  consist  of  pairs  of  OELs  which  are  set  independently  based  on  the  different 
health  effects  of  the  inhalable  (‘I’)  and  the  respirable  fraction  (‘R’).  The  inhalable  fraction  OEL 
addresses non-carcinogenic effects and the respirable fraction OEL addresses carcinogenic effects.  

In its scientific opinion225, RAC derived the following pair of OELs from human and animal studies 
based on inflammatory effects: 1 µg/m³ (I) and 0.5 µg/m³ (R). The proposed OELs (option 1) are 
based on a mode of action-based threshold for the carcinogenicity of cobalt compounds. The risk 
associated with the respirable OEL is close to 4:100,000. 

Following discussions within its WPC, the ACSH recommended in its tripartite opinion226 to set the 
following pair of OELs for cobalt and its inorganic compounds: 10 µg/m³ (I) and 2.5 µg/m³ (R), 6 
years after the entry into force of the initiative subject to this impact assessment. In the meantime, it 
recommended a transitional pair of OELs: 20 µg/m³ (I) and 4.2 µg/m³ (R). The risk associated with 
the  respirable  OEL  is  close  to  4:1,000.  Since  those  two  pairs  of  options  are  supported  by  the 
relevant  stakeholders,  in  particular  the  social  partners  and  Member  States  authorities  represented  
within the ACSH, they were also set as policy options 4 and 5.  

Finally  and  given  the  relative  gap  between  the  RAC  and  the  ACSH  recommendations,  a 
intermediate pair of OELs (5 µg/m³ (I) and 1.25 µg/m³ (R)) was set (option 3).    

2.  PAHs 

In its scientific opinion227, RAC concluded that it was not possible to derive an OEL under which 
there  will  be  no  expectation  of  a  relevant  residual  cancer  risk.  For  that  reason,  RAC  did  not 
recommend any OEL. Instead, it derived a cancer exposure-risk relationship (ERR) expressing the 
excess  risk for lung  cancer  as  a function of the  air concentration of BaP (considered  as a marker 
substance for carcinogenic PAHs). Therefore, the RAC opinion could  not  be used to  set  a policy 
option.  

225 RAC (2022), Opinion on scientific evaluation of occupational exposure limits for cobalt and inorganic cobalt 
compounds, available at: 
https://echa.europa.eu/documents/10162/7937606/final_rac_oel_opinion_cobalt_en.pdf/d96755b2-8bd0-afe7-ab94-
0a2f263fc593?t=1675065309296 
226  ACSH  (2023),  Opinion  on  an  EU  BOEL  and  notations  for  cobalt  and  its  inorganic  compounds,  Doc.  005/23, 
available at: ACSH Adopted opinion Cobalt and inorganic compounds 22.09.23-EN.pdf (europa.eu) 
227 RAC (2022), Opinion on scientific evaluation of occupational exposure limits for polycyclic aromatic hydrocarbons, 
available at: 06454dd9-cadc-acef-a11b-439f2a0d8efa (europa.eu)  

281 

 
 
 
 
 
 
The ACSH recommended in its tripartite opinion228 an OEL of 70 ng/m³ (measured as BaP), which  
was set as policy option 3.  

On top of this policy option, the OELs corresponding to an excess risk of 4:100,000 and 4:1,000 
were also retained: 7 ng/m³ (option 2) and 700 ng/m³ (option 4), respectively.  

3.  1,4-dioxane  

In  its  opinion229,  RAC  recommended  an  OEL  of  7.3  mg/m³  (2  ppm)  for  1,4-dioxane.  This  OEL 
assumes a mode of action-based threshold for the carcinogenic effects of this substance.   

The  ACSH  recommended  in  its  tripartite  opinion230  the  OEL  of  7.3  mg/m³  (2  ppm)  proposed  by 
RAC.  Since  this  option  supported  by  the  relevant  stakeholders  within  the  ACSH  and  by  RAC,  it 
was set as policy option 2. 

Two  additional  options  for  OEL  for  1,4-dioxane  were  retained  for  the  purpose  of  this  impact 
assessment.  First,  the  lowest  national  OEL  currently  in  place  in  Latvia  and  the  Netherlands:  20 
mg/m³ (5.5 ppm – option 3). The third policy option is 36 mg/m³ (10 ppm – option 4), which is the 
most common value of  existing  national  OELs  between 73 mg/m³  (current  indicative OEL under 
CAD) and 20 mg/m³.  

RAC  also  recommended  a  BLV  of  45  mg  2-hydroxyethoxyacetic  acid  (HEAA)/g  creatinine.  A 
BLV is the limit of the concentration in the appropriate biological medium of the relevant agent, its 
metabolite, or an indicator of effect.  

RAC provides a relationship231 between the mean urinary HEAA levels after the end of exposure 
(extrapolated  to  8  hours)  and  the  air  concentration  of  1,4-dioxane.  Based  on  this  correlation,  the 
following policy options for BLVs corresponding to the retained options for OELs were set: 45 mg, 
108 mg and 188 mg.  

4.  Isoprene 

Despite  the  absence  of  significant  CDB  and  FDB  associated  with  occupational  exposure  to 
isoprene, several policy options were assessed, including the option unanimously recommended by 
stakeholders, in line with Better Regulation guidelines. Assessing policy options for limit values is 

228 ACSH (2023), Opinion on an EU BOEL for polycyclic aromatic hydrocarbons, Doc. 003/23, available at:  ACSH 
Adopted opinion PAHs 22.09.23-EN.pdf (europa.eu) & Addendum to ACSH opinion 003/23, available at: Addendum 
to ACSH opinion PAHs-EN.pdf (europa.eu) 
229  RAC  (2022),  Opinion  on  scientific  evaluation  of  occupational  exposure  limits  for  1,4-dioxane,  available  at: 
686365df-9485-c2ac-b342-289ec306d188 (europa.eu) 
230 ACSH (2023), Opinion on an EU BOEL, STEL, BLV and skin notation for 1,4-dioxane, Doc. 007/23, available at: 
ACSH Adopted opinion 1_4-dioxane 22.09.23-EN.pdf (europa.eu) 
231 Urinary HEAA level (in mg/g creatinine) at the end of exposure = 17.82 x (air concentration of 1,4 dioxane in ppm) 
+ 9.58.  

282 

 
 
 
 
 
also in line with the obligation laid down in the CMRD and requiring that limit values should be 
established for all those carcinogens, mutagens or reprotoxic substances for which this is possible. 

RAC recommended the following OEL: 8.5 mg/m³ (3 ppm)232. According to RAC, this value is in 
relative alignment with the natural variation of isoprene produced endogenously in humans. More 
information is available in the RAC opinion.  

In its opinion, the ACSH supported the OEL recommended by RAC. Since this option supported by 
the relevant stakeholders within the ACSH, it was set as a policy option. 

In addition, the following policy options for OEL were retained in this impact assessment: 

•  40 mg/m3, corresponding to the median value for existing national OELs within the EU; and  
•  129.4 mg/m3, corresponding to a cancer risk level of 4:1,000233. 

5.  Welding fumes 

The  evidence  gathered  indicates  that  some  employers  are  not  aware  that  their  welding  processes 
may  contain  carcinogens,  mutagens  or  reprotoxic  substances.  This  driver  was  supported  by  the 
tripartite  ACSH  in  its  opinion234.    Consequently,  and  despite  welding  can  be  a  relatively  safe 
activity if all the safety and exposure control measures are in place, it remains a prominent concern 
that welders are at high risk from various diseases, including cancers235.  

According to ECHA236 in its scoping study on welding fumes, an entry of welding fumes in Annex 
I would bring clarity about employers’ duties and which measures have to be taken. With the legal 
clarity  brought  by  this  inclusion,  employers  would  be  aware  that  welding  fumes  might  contain 
substances  covered  by  the  CMRD,  and  consequently  the  risk  management  measures  provided  by 
the CMRD must apply.  

The  policy  option  of  an  entry  of  welding  fumes  in  annex  I  to  the  CMRD  was  supported  in  its 
opinion237  by  the  ACSH.  The  three  interest  groups  consider  that  an  inclusion  into  annex  I  to  the 
CMRD might indicate to stakeholders that more needs to be done to ensure that the RMMs are in 
place and will bring clarity about employer’s duties on measures to be taken.  

232 RAC (2022), Opinion on scientific evaluation of occupational exposure limits for isoprene, available at:  11c4dd13-
2117-8cd1-83d6-44fc9e591b8f (europa.eu) 
233 Based on the ERR derived by RPA in the absence of an ERR in the RAC opinion 
234  ACSH  (2023),  Opinion  on  introducing  work  involving  exposure  to  fumes  from  welding  processes  containing 
substances  that  meet  the  criteria  for  CMR  category  1A/1B  set  out  in  Annex  I  to  the  CLP  Regulation,  Doc.  006/23, 
available at: ACSH Adopted opinion Welding fumes 22.09.23-EN.pdf (europa.eu) 
235  ECHA  (2022),  Scoping  Study  report  for  evaluation  of  limit  values  for  welding  fumes  and  fumes  from  other 
processes that generate fume in a similar way at the workplace, available at: report_welding_fumes_en.pdf (europa.eu)  
236 ECHA (2022), op. cit. 
237 ACSH (2023), op. cit.  

283 

 
 
 
 
 
 
ANNEX 10: ACCOMPANYING MEASURES AND OPTIONS DISCARDED  

1.  Accompanying measures  

1.1. STEL 

STEL values, usually involving a 15-minute reference period, are used when adverse health effects 
are  not  adequately  controlled  by  compliance  with  an  8-hour  TWA  OEL,  e.g.  for  substances  for 
which  a  critical  effect  is  observed  following  a  brief  exposure  (e.g.  acute  toxic  substances, 
substances causing nuisance, irritation, central nervous system depression, sensitisation). 

RAC  recommended  a  STEL  for  1,4-dioxane,  only.  No  data  are  available  for  the  costs  of 
compliance  with  the  STEL  options.  However,  it  can  be  assumed  that  compliance  with  the  OEL 
option would also mean that the relevant companies would comply with a STEL at a higher level. 
The ratios between the STELs and OELs currently in place in the Member States that have both an 
OEL and a STEL are summarised below. 

Table 120 - STEL/OEL factors (rounded) 

Member State(s) or source 

AT, CZ, DE, DK, FR, SI 
LT, SE 
FI 
RAC opinion 
Source: RPA (2024) 

STEL/OEL ratio 
2 
3 
4 
10 

Although  peak exposures may be significantly higher than the 8-hour TWA, the fact  that several 
Member  States  have  STELs  at  2  to  4  times  the  value  of  the  OEL  lends  some  support  to  the 
contention that compliance with an OEL of 7.3 mg/m3 is likely to ensure compliance with a STEL 
at ten times this value, i.e. 73 mg/m3. This would mean that no additional costs would be expected 
from  complementing  an  OEL  of  7.3  mg/m3  with  a  STEL  at  least  10  times  higher,  with  the 
exception  of  additional  measurement  costs  in  cases  where  companies  are  particularly  concerned 
about specific high-exposure activities.  

1.2. Notations 

OELs,  STELs  and/or  BLVs  can  further  be  annotated  with  appropriate  indications  of  additional 
body burden resulting from non-inhalation routes such as: 

284 

 
 
 
 
 
 
 
•  “Skin”  notation  where  the  dermal  route  of  exposure  is  scientifically  considered  to  be 

relevant. 

•  “Skin sensitisation” where the substance can cause sensitisation of the skin. 
•  “Respiratory  sensitisation”  where  the  substance  can  cause  sensitisation  of  the  respiratory 

tract.   

In its scientific opinions, RAC recommended the following notations:  

•  “Skin  sensitisation”  and  “respiratory  sensitisation”  for  cobalt  and  inorganic  cobalt 

compounds;  

•  “Skin” notation for 1,4-dioxane; and  
•  “Skin” notation for PAHs. 

The notations are irrespective of the level of the limit values.  

1.3. Possible revision of the SLIC guidance on welding fumes 

On  7  May  2024,  the  SLIC  adopted  a  new  mandate  for  its  specific  working  group  on  chemical 
agents (WG CHEMEX) for 2024-2027. This new mandate provides for an evaluation of the need 
for a revision of any previous produced documents by the WG CHEMEX. This task could result in 
the revision of the existing SLIC guidance document for national labour inspectors on addressing 
health  risks  from  welding  fume238.  This  guidance  document,  which  was  developed  in  2018,  for 
national  labour  inspectorates,  aims  to  increase  inspectors’  competences  and  confidence  during 
enforcement activities related to health risks from welding fumes activities and exposure to welding 
fumes.  In  the  absence  of  specific  information  on  if  and  how  this  guidance  document  will  be 
updated,  the  effects  of  this  option  could  not  be  assessed  and  considered  under  this  impact 
assessment. However, it is likely that an update of this guidance document will be complementary 
to the inclusion of welding fumes in the Annex I of the CMRD and result in better protection for 
workers.   

2.  Isoprene-related discarded option 

This section outlines the baseline for isoprene and provides with a detailed assessment of the costs 
and benefits for the limit value recommended by the ACSH.  

2.1. What is the baseline  

238 SLIC (2018), Guidance for National Labour Inspectors on addressing health risks from Welding Fume. Available at: 
https://circabc.europa.eu/ui/group/fea534f4-2590-4490-bca6-504782b47c79/library/2997b89a-1fbd-4f35-9874-
9a9b5ea1a403?p=1&n=-1&sort=name_ASC 

285 

 
 
 
 
 
Around 10,500 workers are currently exposed to isoprene in the EU. These workers are divided in 
two sectors: manufacture of refined petroleum products (97%) and manufacture of synthetic rubber 
in primary forms (3%).  

The refinery capacity in the EU is expected to decrease as a consequence of the ban of sale of new 
diesel  and  gasoline  driven  cars  and  vans  from  2035.  The  evidence  gathered239  suggests  that  this 
decrease  of  the  refinery  capacity  would  be  of  6%  per  year.  The  number  of  workers  exposed  to 
isoprene in this sector is assumed to follow the same trend. With regard to the synthetic rubber in 
primary forms manufacturing sector, based on the annual compound growth rate for this sector240, it 
is expected that the number of exposed workers increase by 7% per year over the reference period. 
Overall, the number of exposed workers will decrease over that period since most of these workers 
are operating the manufacture of refined petroleum products. No forthcoming changes in national 
limit values or other relevant national legislation have been identified. 

According to  the evidence gathered241, including  the RMMs  currently in  place (see section 2 and 
annex  6)  workers  operating  in  those  two  sectors  are  exposed  on  average  to  levels  of  isoprene  of 
0.20  mg/m3  and  0.25  mg/m3,  respectively.  The  maximum  exposure  levels  recorded  in  the 
manufacture of refined petroleum products are higher than for manufacture of synthetic rubber in 
primary forms: 1.36 mg/m3 vs 0.76 mg/m3. The evidence gathered indicates that the limit value of 
0.66 mg/m³ for benzene (which will enter into force in April 2026) and the future limit value for 
PAHs is likely to impact downwards workers’ exposure to isoprene in some activities (e.g. steam 
cracking and refining). However, as the exposure levels to isoprene in the EU are alrealy below the 
health-based limit value derived by RAC, their effects have not been factored into the baseline as 
they would not have any effects on the impacts assessed under section 6.  

The  exposure  levels  in  both  sectors  are  expected  to  keep  stable  over  the  reference  period.  The 
evidence  gathered  indeed  suggest  that  in  both  sectors,  RMMs  are  currently  implemented  to  the 
most extent possible (i.e. closed systems and respiratory protective equipment (RPE) in high risks 
tasks such as maintenance). 

According  to  the  evidence  gathered242,  the  present  workers’  exposure  levels  are  very  low.  As  a 
result, the FDB is also expected to be very low or even 0.  

The above assumptions and estimates should be treated with cautious due to limited availability of 
data, including exposure data.  

Table 121: baseline scenario for isoprene over 40 years 

Number of exposed workers 
Change in exposure level 

10,539 
0% 

239 RPA (2024), op. cit.  
240 RPA (2024), op. cit., isoprene report, section 3.4.5. 
241 RPA (2024), op. cit. 
242 RPA (2024), op. cit.  

286 

 
 
 
 
 
Change in number of exposed workers 

Future disease burden (FDB) from current and future 
exposure – Number of cases over 40 years 

-  -6% for petroleum products manufacturing 
-  +7% for synthetic rubber manufacturing  
0.03 
-  0.03 (liver cancer) 
-  0 (degeneration of olfactory epithelium and spinal 

Estimated deaths due to FDB cancer over 40 years 
Monetary value FDB cancer over 40 years 

Monetary  value  FDB  other  adverse  health  effects 
over 40 years 
Source: RPA (2024) 

cord white matter) 

0 
-  Method 1: €40,000 
-  Method 2: €50,000 
€0 

2.2. Description of the policy option  

Option 2 corresponds to the health-based limit value derived by RAC in its opinion and is also the 
limit  value  recommended  by  the  ACSH,  namely  8.5  mg/m³.  This  option  also  corresponds  to  the 
threshold limit value derived by RAC in its opinion. In the absence of problem for workers exposed 
to isoprene, no additional option than the OEL recommended by social partners and Member States 
authorities  represented  in  the  WPC/ACSH  was  originally  retained  for  the  purpose  of  this  impact 
assessment.  

2.3. What are the impacts of the policy option for isoprene 

2.3.1.  Social impacts  

(a)  Impacts on workers’ health 

No expected impact on workers’ health, regardless of POs. 

(b) Impacts on employment 

No expected impact on employment, regardless of POs. 

2.3.2.  Economic impacts  

(c)  Impacts on businesses, including SMEs  

While  businesses  are  not  expected  to  bear  any  adjustment  costs  (discontinuation  costs  and 
investment  in  RMMs)  under  PO  2,  they  would  nevertheless  face  additional  monitoring  and 
administrative costs.     

287 

 
 
 
 
 
 
Although  the  current  exposure  levels  are  below  PO  2,  it  is  assumed  that  businesses  operating  in 
Member States with no or higher national limit value than PO 2 would need to show compliance 
with the new or revised limit value243.  

Overall,  business  will  spend  €190,000  under  PO  2  over  40  years.  About  70%  of  the  total 
monitoring costs will be supported by large companies. 

Table 122: total estimated costs of two additional air monitoring campaigns in € million over 40 years by 
policy option and size of company  

Policy options 

PO 2 (8.5 mg/m³) 
Source: RPA (2024) 

Small 
0.02 

Total costs (€ million) 
Large 
Medium 
0.13 
0.03 

Total 
0.19 

The administrative costs associated with the monitoring campaigns amount to €110,000 under PO 2 
over 40 years. As for the monitoring costs, most of the administrative costs would be supported by 
larger companies.  

Table 123: total estimated costs of administrative burden of additional air monitoring by policy option and 
size of company over 40 years 

Policy options 

PO 2 (8.5 mg/m³) 
Source: RPA (2024) 

Total costs (€ million) 

Small 
0.01 

Medium 
0.01 

Large 
0.09 

Total 
0.11 

Overall, businesses are  expected to  support compliance costs amounting  to  €160,000 under PO 2 
over 40 years, which would represent €4,000 per company over the same period. Businesses would 
dedicate  0.002%  of  their  turnover  as  compliance  costs  (scenario  of  small-  and  medium-sized 
enterprises operating in synthetic rubber manufacture sector under PO 2).    

(d) Impacts on competitiveness  

Given  the  negligible  compliance  costs,  including  compared  to  the  turnover,  no  impact  on 
competitiveness is expected, regardless of the PO.  

(e)  Impacts on the single market 

The  introduction  of  an  EU-wide  OEL  for  isoprene  would  result  in  less  divergencies  between 
Member States  with  regard to  the national  OELs,  in  particular given the low number of Member 

243 All Member States except DE under policy option 2.  

288 

 
 
 
 
 
 
 
States  with  an  existing  OEL.  This  more  homogenous  regulatory  framework  for  isoprene  would 
theoretically improve the functioning of the internal market by creating a more level playing field. 
However, this impact would be negligible given the current low levels of exposure for workers in 
all Member States.   

(f)  Impacts on public authorities/Member States   

As only 5 Member States have a national OEL for isoprene, most of the Member States would have 
to bring changes in their national legislations in the event of an EU-wide OEL. Furthermore, some 
Member States will also need to adapt their existing OEL under PO 2 (BG, LT, LV and PL).  

Assuming  that  modifying  an  existing  OEL  is  less  costly  than  introducing  a  new  OEL,  the 
transposition costs for PO 2 would account for €1.22 million.  

While public authorities  would not  avoid  costs of ill  health under PO 2, they would  not have to 
devote resources to setting their own national OEL (e.g. an impact assessment). The avoided costs 
related  the  setting  of  an  OEL  at  national  level  would  amount  to  €2.4  million  under  PO  2. 
However, these avoided costs are very theoretical as it is unlikely that Member States with no OEL 
for  isoprene  would  devote  resources  for  setting  a  national  OEL  given  the  expected  absence  of 
benefits  for  workers  and  businesses.  Therefore,  it  is  considered  that  there  would  be  no  avoided 
costs for public authorities.   

As PO 2 is expected not to entail any costs to businesses, there would be no specific Member States 
that would be particularly impacted.  

(g) Impacts on digitalisation   

None of the POs are expected to impact sectors with exposed workers to isoprene. Therefore, and 
even if polyisoprene may be used in electronics (photoresists in semiconductor manufacturing244), 
no impact on digitalisation is expected, regardless of the PO.   

2.3.3.  Social impacts  

No expected direct or indirect impact on environment, regardless of the PO.  

2.4. How do the options compare? 

Effectiveness: PO 2 would result in avoided ill-health cases compared to the baseline and its impact 
on workers’ health is therefore zero compared to the baseline.  

244 Fujifilm (2023), Fujifilm website “Negative (Polyisoprene-based)”, 
https://www.fujifilm.com/uk/en/business/semiconductor-materials/photoresists/negative 

289 

 
 
 
 
 
Since only 5 Member States currently have a limit value for isoprene, introducing a limit value at 
EU level would theoretically contribute to a better playing field in the single market, however, the 
real impact is likely to be zero given the already very low levels of exposure for workers in the EU.  

As PO 2 is fully consistent with the recommendation of the ACSH, this should theoretically have a 
positive  impact  on  its  effectiveness  in  terms  of  ill-health  cases  avoided.  However,  since  it  is 
expected that all workers in the EU are already exposed to safe levels of isoprene, businesses will 
not invest in additional RMMs. Therefore, the real impact of the full consistency with the ACSH 
opinion on the effectiveness is zero too.   

Efficiency:  the  C/B  ratio  of  PO  2  for  isoprene  could  not  be  calculated  in  the  absence  of  any 
benefits.  

PO  2  is  expected  to  entail  monitoring  and  administrative  costs  for  businesses,  amounting  to 
between €300,000 (€4,000 per company on average). These costs would not exceed 0.002% of the 
turnover, irrespective of the sector or the size of the company and are therefore  and the negative 
impact is therefore very small compared to the baseline.  

No discontinuation or job loss is expected under PO 2. 

Coherence: In the absence of benefits, PO 2 would not contribute to Europe’s Beating Cancer Plan. 
Furthermore, no impacts on the other key EU policies arising from PO 2 were identified.  

Table 124 – Comparative scoring of the policy options for isoprene  

Effectiveness 
Number of cancer and non-cancer cases avoided  
Contribution towards a better level playing field 
Consistency with the recommendation of the ACSH 
Total effectiveness  
Efficiency 
Costs/benefits ratio (C/B ratio) 
Costs compared to turnover  
Number of discontinuations and job losses 
Total efficiency 
Coherence 
Coherence with Europe’s Beating Cancer Plan  
Coherence with other key EU policies (EU Green Deal, EU strategic 
autonomy, digital transition)   
Total coherence  
Overall score 

PO 2 

0 
0 
0 
0 

NA 
(-) 
0 
(-) 

0 
0 

(-) 

3.  Options discarded at an early stage 

3.1. Banning the use of the substances subject to this impact assessment  

290 

 
 
 
 
 
 
 
 
Substitution is the first option in the hierarchy of RMMs under the CMRD that an employer has to 
consider.  This  means  that  if  it  were  technically  feasible,  employers  should  already  have  replaced 
use of the concerned substance with safer alternatives. 

3.2. Directly adopting the most stringent national limit values 

Wherever substitution is a suitable alternative for use of the chemical agents in question the CMRD 
already  requires  this,  regardless  of  the  existence  of  a  limit  value.  As  this  legal  standard  already 
establishes that these substances should not be used in the workplace where  safer alternatives are 
available, establishing a stricter prohibition in the form of a ban would constitute disproportionate 
measure with a strong negative impact on businesses and, in for some substances such as cobalt, on 
key EU objectives, such as the green transition. Further, it is not under the remit of the CMRD to 
ban substances.  

For  most  of  the  carcinogens  some  Member  States  adopted  limit  values more  stringent  than  some 
policy options considered in this impact assessment. It could be argued that such limit values could 
be  made  binding  across  the  EU  based  on  an  assumption  that  what  is  achievable  in  one  Member 
State should be achievable in all.  

However, the EU sets minimum standards in this area and OELs need to be seen in the context of 
the  minimisation  principle.  This  means  that  industries  have  the  obligation  to  minimise  exposure 
below  existing  OELs  if  that  is  technically  feasible.  Furthermore,  national  economies  can  vary 
greatly  among  Member  States,  including  regarding  the  representativity  of  different  sectors. 
Therefore,  the  impacts  resulting  from  some  policy  options  can  also  be  highly  different  between 
Member States.  

3.3. Providing industry-specific scientific information without amending the CMRD  

Another  option  could  be  for  the  Commission  to  collect  and  provide  industry-specific  scientific 
information  to  support  employers  in  complying  with  the  CMRD  obligations.  Apart  from  the 
practical difficulties related to collection of relevant data for the multitude of sectors concerned, it 
is considered that this option would not be effective in achieving the objectives of the initiative for 
the following reasons:  

• 

the  way  the  information  is  used  by  employers  would  not  be  enforceable  by  surveillance 
authorities; 

•  such  an  option  would  not  fit  with  the  overarching  legal  framework  of  the  CMRD,  which 
provides for general exposure management requirements to be specifically supplemented by 
EU-wide minimum standard limit values;  

291 

 
 
 
 
• 

in  some  cases,  extensive  industry-  and  chemical  agent-  specific  information  and  guidance 
already exists and should be taken into account by employers during risk assessments – but 
this has not demonstrably addressed harmful exposures at EU level. 

3.4. Guidance documents  

As  non-regulatory  alternatives,  guidance  documents  or  examples  of  good  practice  could  be 
developed and disseminated in co-operation with the EU-OSHA and/or the ACSH and its relevant 
working  party.  This  could  also  include  the  development  of  awareness  raising  campaigns  for 
employers and workers alike on the prevention of risks arising from workers' exposure to categories 
1A and 1B carcinogenic, mutagenic and reprotoxic substances and on the scope of the CMRD, such 
in  the  case  of  welding  fumes.  However,  guidance  documents  by  itself  would  not  be  considered 
effective enough in reaching the objectives of this initiative. They are complementary and provide 
an added value to setting OELs. 

Regarding  welding  fumes,  several  guidance  documents  already  exist  at  EU-level.  In  2018,  the 
Senior Labour Inspectorate Committee developed a European Guidance on addressing health risks 
from  welding  fumes245.  Although  this  guidance  was  developed  for  inspectors,  it  is  also  fit  for 
businesses.  With  this  document,  they  can  also  ensure  compliance  with  its  requirements.  This 
guidance  includes  background  information  such  as  health  risks,  types  of  welding  the  legal 
framework for regulation, typical control measures, health surveillance and key information. It also 
includes a welding fumes task sheets with specialised guidance on each welding activity including 
approaches to control welding fumes exposure, illustrative photographs, etc. 

Another  guidance  document  was  developed  by  the  European  Welding  Association  (EWA).  This 
guidance246  includes  different  exposure  scenarios  and  operational  conditions,  with  recommended 
RMMs,  with  the  aime  of  outlining  how  metals,  alloys  and  metallic  articles  and  mixtures  can  be 
safely welded with respect to exposure to welding fumes and gases. 

Despite the existence of guidance at EU level, the evidence gathered shows that the welding fumes-
related  problem  persists.  Therefore,  the  development  of  a  new  guidance  was  not  considered 
relevant to address the problem.  

3.5. Setting a limit value for welding fumes  

245 SLIC (2018), Guidance for National Labour Inspectors on addressing health risks from Welding Fume. Available at: 
https://circabc.europa.eu/ui/group/fea534f4-2590-4490-bca6-504782b47c79/library/2997b89a-1fbd-4f35-9874-
9a9b5ea1a403?p=1&n=-1&sort=name_ASC 
246 EWA (2021), Welding Exposure Scenario – ENGL. Available at : WES-EWA-TCC-458-2021-05-English-002.pdf 

292 

 
 
 
 
 
 
With regard to welding fumes, the purpose of the initiative subject to this impact assessment is  to 
improve clarity on the scope of the CMRD. The setting of a limit value for welding fumes would 
not  have  allowed  for  providing  more  legal  clarity  and  cannot  therefore  be  considered  as  an 
alternative to the inclusion of welding fumes in Annex I of the CMRD.  

Currently,  welding  fumes  have  no  EU-wide  limit  value  covering  all  its  fumes.  However,  for  the 
majority  of  metals  involved  in  the  composition  of  these  fumes,  there  is  already  an  existing  limit 
value in Annex III of the CMRD. Furthermore, the setting of a limit value in the CMRD require a 
scientific opinion from RAC. So far, the Commission only has a scoping study of ECHA to support 
a possible inclusion of welding fumes in Annex I, not a scientific opinion from RAC. Finally, the 
heterogeneous character of welding fumes makes it very difficult to establish a common OEL for 
all welding processes.  

For  all  the  above  reasons,  the  establishment  of  a  limit  value  covering  all  welding  fumes  was 
discared.  

3.6. Adapted solutions for SMEs 

SMEs should not be generally exempted from the scope of the  initiative as their exclusion would 
mean  that  a  very  significant  number  of  European  workers  would  not  be  covered  by  health  and 
safety  at  work  legislation,  with  a  clear  distortion  and  inequality  in  the  application  of  the  EU 
legislative framework and with a risk of compromising the underlying social policy objectives and 
fundamental rights. Furthermore, applying less stringent rules to SMEs in the area of OSH would 
also  negatively  impact  their  ability  to  attract  workers  as  the  latter  would  favour  better  working 
conditions.  

293 

 
 
 
 
 
 
 
 
ANNEX 11: CONSISTENCY AND COMPLEMENTARITY WITH THE REACH 
REGULATION 

Restrictions under REACH 

1.  COBALT  

1.1.  Restrictions  

None of the substances within the scope of this impact assessment are subject to restrictions under 
REACH.  For  five  cobalt  salts,  a  restriction  proposal  was  prepared  by  ECHA  in  2018,  but  the 
proposal has been withdrawn by Commission Decision of 8th April 2022 on the termination of the 
restrictions  process  on  cobalt  sulphate,  cobalt  dichloride,  cobalt  dinitrate,  cobalt  carbonate  and 
cobalt di(acetate) under REACH.  

A  number  of  arsenic,  cadmium,  nickel,  lead,  and  inorganic  ammonium  substances  subject  to 
restrictions  contain  cobalt,  but  none  of  the  substances  are  registered  and  consequently  out  of  the 
scope  of  this  study.  The  relevant  entries  in  REACH  Annex  XVII  are  as  follows:  Arsenic 
compounds  (entry  19),  cadmium  and  its  compounds  (entry  23),  nickel  and  its  compounds  (entry 
27), lead and its compounds (entry 63), and inorganic ammonium salts (entry 65). 

1.2.  Authorisation 

None  of  the  substances  within  the  scope  of  this  impact  assessment  are  subject  to  authorisation 
under of REACH.  

1.3.  Chemical Safety Reports (CSRs)  

As  part  of  the  registration  processes  for  the  substances  within  the  scope  of  the  study,  companies 
have prepared CSRs which among others include an exposure assessment and risk characterisation 
that  address  all  the  identified  hazards  of  the  substance.  The  CSRs  include  for  all  Worker 
Contributing Scenarios (WCS) a description of the operational conditions and the risk management 
measures.  This  CSRs  provide  key  information  for  the  risk  assessments  to  be  undertaken  in 
accordance with the requirements of the CMRD.  

1.4.  Classification and Labelling Inventory (C&L Inventory)  

This database contains classification and labelling information on notified and registered substances 
received  from  manufacturers  and 
importers  (self-classification)  as  well  as  harmonised 
classifications  as  listed  in  the  CLP.  Companies  have  provided  this  information  in  their  C&L 
notifications or registration dossiers. Where there is a difference in the classification and labelling 
of  the  substance  between  potential  registrants,  the  obligatory  Substance  Information  Exchange 

294 

 
 
 
 
 
Forums (SIEF) shall agree on the classification and labelling. For substances without harmonised 
classification,  the  self-classifications  are  used  as  basis  for  the  human  health  hazard  assessment 
undertaken as part of the REACH registration process.  

1.5.  Risk management option analysis  

A risk management option analysis (RMOA) for five cobalt salts from 2017 concluded that follow-
up regulatory action at EU level was needed and that a restriction would be the most appropriate for 
the  five  substances.  The  restriction  process  has  later  been  terminated  as  described  above  and 
replaced by the policy option of establishing an OEL. For cobalt metal and other inorganic cobalt 
compounds no RMOA has been developed. 

2.  PAHS 

The substances  within the scope of the study are not  subject  to  the requirements for  registrations 
under REACH.  Some PAH are manufactured industrial chemicals, but many are process generated 
and are not subject to REACH registration.  

PAH occur almost always in mixtures of several PAH and are formed during incomplete pyrolysis 
or  combustion  and  pyrolysis  processes  of  organic  materials,  such  as  coal  and  wood.    The 
composition of the mixture is varied and depends on the process that generates them as well as the 
materials involved.  

Some substances contain PAH that are released upon use.  For example, anthracene oil (EC 292-
602-7) and pitch, coal tar, high temp. (CTPHT) (EC number 266-028-2).  These may be subject to 
REACH registrations and other REACH processes. 

2.1.  CSRs 

None  of  the  substances  are  registered,  however  some  substances  known  to  contain  PAH  are 
registered.    As  part  of  the  registration  processes  for  these  substances,  companies  have  prepared 
CSRs  which  among  others  include  an  assessment  of  occupational  exposure  and  environmental 
exposure.   

Table 125 - list of substances containing PAH for which CSR have been obtained and used in the assessment  

Substance 

EC number 

Pitch, coal tar, high-temp. 

266-082-8 

2.2.  C&L Inventory 

This database contains classification and labelling information on notified and registered substances 
importers  (self-classification)  as  well  as  harmonised 
received  from  manufacturers  and 

295 

 
 
 
 
 
classifications as listed in the CLP.  The carcinogenic PAHs have a harmonised C&L and therefore 
the inventory was not consulted for self-classifications.  

2.3.  Restrictions  

The table below presents the current REACH restriction of PAH. 

Entry 

Substance 

Table 126 - REACH restrictions on PAH 
EC 
number 

Restriction 

50 

Benzo[a]pyrene 
(BaP) 
Benzo[e]pyrene 
(BeP) 
Benzo[j]fluorant
hene (BjFA) 
Benzo[a]anthrace
ne (BaA) 
Chrysene (Chr) 
Dibenzo[a,h]anth
racene (DBAhA) 
Benzo[k]fluorant
hene (BkFA) 
Benzo[b]fluorant
hene (BbFA) 

205-883-8 

205-910-3 

200-280-6 

205-916-6 

205-923-4 
200-181-8 

200-028-5  The restrictions concern the use of certain products that may 
contain  one  or  more  of  the  PAH  substances  mentioned.  
These include, amongst others: 
1) Extender oils shall not be placed on the market, or used for 
the production of tyres or parts of tyres if they contain: 
- more than 1 mg/kg (0,0001% by weight) BaP, or 
- more than 10 mg/kg (0,001% by weight) of the sum of all 
listed PAH; 
2) Articles shall not be placed on the market for supply to the 
general  public,  if  any  of  their  rubber  or  plastic  components 
that  come  into  direct  as  well  as  prolonged  or  short-term 
repetitive  contact  with  the  human  skin  or  the  oral  cavity, 
under  normal  or  reasonably  foreseeable  conditions  of  use, 
contain  more  than  1  mg/kg  (0,0001%  by  weight  of  this 
component) of any of the listed PAH; 
3) Toys, including activity toys, and childcare articles, shall 
not be placed on the market, if any of their rubber or plastic 
components  that  come  into  direct  as  well  as  prolonged  or 
short-term repetitive contact with the human skin or the oral 
cavity, under normal or reasonably foreseeable conditions of 
use, contain more than 0,5 mg/kg (0,00005% 
by weight of this component) of any of the listed PAH; 
4) Granules or mulches shall not be placed on the market for 
use as infill material in synthetic turf pitches or in loose form 
on playgrounds or in sport applications, if they contain more 
than  20 mg/kg  (0,002 %  by  weight)  of the  sum of  all listed 
PAH. 

205-911-9 

Source: REACH Annex XVII 

A Restriction proposal as well as related opinions by RAC and SEAC have been published in 2022 
that limit the amount of PAH in  clay shooting  targets.  The restriction  is  likely  to  be adopted this 
year. 

296 

 
 
 
 
 
 
 
In addition, creosote and creosote containing substances are included in REACH Annex XVII entry 
31.  The restrictions concern the use of these substances in wood treatment and specify that these 
substances  shall  not  be  placed  on  the  market,  or  used,  as  substances  or  in  mixtures  where  the 
substance or mixture is intended for the treatment of wood.  Furthermore, wood so treated shall not 
be placed on the market.  A further restriction is being considered on the placing on the market, re-
use and secondary use of wood treated with creosote or related substances (ECHA, 2022a). 

2.4.  Authorisation 

None  of  the  substances  within  the  scope  of  this  study  are  listed  in  Annex  XIV  of  REACH. 
Substances  containing  PAH  which  are  released  during  use,  may  be  subject  to  REACH 
authorisations, these are anthracene oil (EC 292-602-7) and pitch, coal tar, high temp. (CTPht) (EC 
266-028-2).   

3.  1,4-DIOXANE  

The substances within the scope of the study are subject to the requirements for registrations under 
REACH.  

3.1.  CSRs 

As  part  of  the  registration  processes  for  the  substances  within  the  scope  of  the  study,  companies 
have  prepared  CSRs  which  among  others  include  an  assessment  of  occupational  exposure  and 
environmental exposure.  

3.2.  C&L Inventory  

This database contains classification and labelling information on notified and registered substances 
received  from  manufacturers  and 
importers  (self-classification)  as  well  as  harmonised 
classifications  as  listed  in  the  CLP.  Companies  have  provided  this  information  in  their  C&L 
notifications or registration dossiers. Where there is a difference in the classification and labelling 
of  the  substance  between  potential  registrants,  the  obligatory  Substance  Information  Exchange 
Forums (SIEF) shall agree on the classification and labelling. For substances without harmonised 
classification,  the  self-classifications  are  used  as  basis  for  the  human  health  hazard  assessment 
undertaken as part of the REACH registration process.  

3.3.  Restrictions 

There  are  currently  no  entries  for  1,4-dioxane  in  Annex  XVII  of  REACH.  However,  a  call  for 
evidence  by  the  German  Federal  Institute  for  Occupational  Safety  and  Health  (BAuA)  was  open 
until 20 July 2023 on a potential Annex XV restriction on the manufacture, placing on the market 

297 

 
 
 
 
and use of 1,4-dioxane in surfactants, motivated by the need to prevent environmental emissions of 
1,4-dioxane. The expected date of submission of the restriction proposal is 2024. 

3.4.  Authorisation 

In 2021, 1,4-dioxane was included in the Substances of Very High Concern (SVHC) Candidate List 
for Authorisation according to REACH Art. 57 (a) and 57 (f),with this triggering substitution and 
information requirements. 

3.5.  Risk management option analysis  

A  Risk  Management  Option  Analysis  (RMOA)  was  completed  by  Germany  in  2020  to  assess 
regulatory  options  following  the  change  of  harmonised  classification  from  C2  to  C1B.  It  was 
concluded that a potential identification as SVHC and a potential Annex XV restriction were to be 
considered. As regards occupational exposure, it was noted that: the currently valid IOELV turned 
out to be obsolete and should not be used from now on as basis for risk assessment. In light of the 
upcoming Carc. 1B classification the provisions of CMRD become relevant and a BOELV should 
be derived. 

4. 

ISOPRENE  

The substances within the scope of the study are subject to the requirements for registrations under 
REACH.   

4.1.  CSRs  

As  part  of  the  registration  processes  for  the  substances  within  the  scope  of  the  study,  companies 
have  prepared  CSRs  which  among  others  include  an  assessment  of  occupational  exposure  and 
environmental exposure.  The CSRs have been a key information source for the current assessment. 

4.2.  C&L Inventory   

This database contains classification and labelling information on notified and registered substances 
received  from  manufacturers  and 
importers  (self-classification)  as  well  as  harmonised 
classifications  as  listed  in  the  CLP.    Companies  have  provided  this  information  in  their  C&L 
notifications or registration dossiers.  Where there is a difference in the classification and labelling 
of  the  substance  between  potential  registrants,  the  obligatory  Substance  Information  Exchange 
Forums (SIEF) shall agree on the classification and labelling.  For substances without harmonised 
classification,  the  self-classifications  are  used  as  basis  for  the  human  health  hazard  assessment 
undertaken as part of the REACH registration process.   

298 

 
 
 
 
 
4.3.  Restrictions  

Isoprene  currently  has  no  restrictions  listed  under  the  REACH  regulation.  Additionally,  isoprene 
has one reported Assessment of Regulatory Needs (ARN) not relating to a proposed restriction and 
no restriction intentions in the Registry of restriction intentions (RoI).  As such it can be expected 
that isoprene will not be restricted under REACH in the near future. 

4.4.  Authorisation 

Isoprene  is  not  currently  included  on  the  candidate  list  or  authorisation  list  under  the  REACH 
regulation.  As such there are no authorisation requirements for this substance.   

4.5.  Risk management option analysis   

An intention for a risk management option analysis (RMOA) was submitted for Isoprene in 2016, 
on  account  of  its  CMR  properties.    Since  this  intention  was  submitted,  no  RMOA  has  been 
conducted. Therefore, introducing Occupational Exposure Limits for isoprene is the only suggested 
regulation for control of the risks posed by this substance at EU level. 

5.  WELDING FUMES  

The  substances  in  welding  fumes  are  process  generated,  produced  during  the  welding  process. 
There  is  no  requirement  for  process  generated  substances  to  be  registered  under  REACH. 
According  to  ECHA  the  base  metals  can  be  considered  to  be  part  of  an  article  whilst  the  filler 
materials could be either articles or mixtures (alloys are special mixtures), and although covered by 
REACH are not subject to REACH registration.  

299 

 
 
 
 
 
 
1.  COBALT AND ITS INORGANIC COMPOUNDS 

ANNEX 12: SME TEST 

Identification of affected businesses 

Table 127 – Cobalt and its inorganic compounds-related SME test 

•  81% of the affected companies are small companies and 13% are medium sized companies.  

•  The share of SMEs is similar across all the most affected sectors (the sectors with highest number 

of exposed workers).  

Consultation with SME stakeholders 

•  SMEs have been consulted as part of stakeholder consultation. The share of SME respondents is 

37% in the stakeholder survey conducted for this study. While this share is lower than the share of 
SMEs in affected companies, SMEs are still well represented.  

•  SME stakeholders express concern that the two lowest OEL options, 1/0.5 µg/m³ and 5/1.25 µg/m³ 

will negatively affect their competitiveness.   

Assessing the impacts on SMEs 

One indicator for assessing the impacts on SMEs is the share of first year costs in annual turnover. While 
there is no specific agreed benchmark for what significant impacts are, when the indicator is above 5%, 
then it will be considered significant in this study. The table presents how many sectors where the indicator 
is above 5% for small and medium companies. This indicates that it is only small companies that face more 
significant challenges for the lower OELs. 

OEL 

Share of sectors where first year costs exceed 5% of 
annual turnover 

Small sized companies 

Medium sized companies 

1 / 0.5 µg Co/m3 

5 / 1.25 µg Co/m3 

10 / 2.5 µg Co/m3 

20 / 4.2 µg Co/m3 

37% 

15% 

7% 

0% 

Minimising the negative impacts on SMEs 

0% 

0% 

0% 

0% 

•  The option proposed by the ACSH with a transitional period of 6 years before the option of the 

OEL 10 / 2.5 µg Co/m³ will be introduced allows companies to plan and finance their investments 
in RMMs over the six-year period. The is will be particular important for SMEs. It means that in all 
sectors, the SMEs will have to invest less than 1 % of turnover in RMMs each year of the 
transitional period.  

•  This is likely to mitigate the possible negative impacts on the SMEs.    

300 

 
 
 
 
 
 
 
2.  PAHS 

Identification of affected businesses 

Table 128 – PAHs-related SME test 

•  99.1% of the affected companies are small companies and 0.7% are medium sized companies.  

•  The majority of sectors under review in the study are primarily made up of SMEs (>90% of all 

companies are SMEs) with the exception of the following sectors: C19.2 (refineries 
approximately half are SMEs), C20.13 (manufacturer of carbon black – around 80% are SMEs), 
C20.14 (coal tar distillation -  approximately 45% are SMEs), C23.99b (graphite and carbon 
electrode manufacture - all are large enterprises), C24.42 (manufacture of aluminium – 
approximately one third are SMEs), and D35.11 (coal fired power plants -  approximately 85% 
are SMEs). All of these sectors have a low number of operating enterprises in the EU indicating 
that the higher percentage of large companies refers to a small number overall. 

Consultation with SME stakeholders 

•  SMEs have been consulted as part of stakeholder consultation. The share of SME respondents is 
38% in the stakeholder survey conducted for this study. SME responses were only provided in 
regard to C19.2 (refineries), C20.13 (manufacture of carbon black), C20.14 (coal tar distillation), 
C24.42 (manufacture of aluminium), C24.5 (casting of metals), F42.11 (road paving) and may 
not provide a robust representation of these sectors. 

•  SME respondents unilaterally believed that the most stringent policy options (7 and 70 ng/m3) 

would have negative impact on EU competition. At 700 ng/m3 SME respondents were split as to 
whether EU competition would be impacted (this was felt to be negative for C20.13 
(approximately half of SME sector respondents) and C20.14. the remaining sectors believed 
there would be limited/no impact at this level.  

•  All respondents believed 7 and 70 ng/m3 would have negative impacts on global competition. At 
700 ng/m3 approximately half of the respondents believed there would be limited/no impact. 
Those that believed there would be negative impacts were in C20.13 and C20.14.  

•  However, these results should be read with caution as they are not a representative sample of the 

sectors. 

Assessing the impacts on SMEs 

•  One indicator for assessing the impacts on SMEs is the share of first year costs in annual 

turnover.  

•  At the lowest policy option, in approximately half the sectors, small and medium sized 

enterprises will experience high costs as a percentage of turnover. Sectors with high percentages 
for SMEs include C16.1 wood preservation, C19.2 petroleum refineries, C20.14 coal tar 
distillation, C23.2 manufacture of refractor products, C23.99a manufacture of bituminous 
products, C24.1 steel and iron foundries, C24.45 other non-ferrous metallurgy, C24.5 casting of 
metals, D35.11 coal fired power plants, E39 soil remediation, F42.12 welding of railroad tracks, 
and N81.22 chimney sweeps. Also coking plants (C19.1) are heavily impacted at this level due 
to 100% of companies discontinuing. 

•  At the 70 ng/m3 policy option SMEs are potentially disadvantaged, albeit to a lesser extent than 

at ng/m3 in the following sectors: C16.1 wood preservation, C19.1 coking plants, C19.2 
petroleum refineries, C23.2 manufacture of refractory products, C24.1 steel and iron foundries, 

301 

 
 
 
 
C24.45 other non-ferrous metallurgy, C24.5 casting of metals, D35.11 coal fired power plants, 
E39 soil remediation, and F42.12 welding of railroad tracks.  

•  At 700 ng/m3 and 2000 ng/m3 SMEs may also have high costs as a percentage of operating 

surplus in C16.1 wood preservation, C23.2 manufacture of refractory products, C24.1 steel and 
iron foundries, and D35.11 coal fired power plants. 

• 

In terms of R&D, the introduction of OELs this may result in proportionally less R&D being 
performed by small and medium companies than large (albeit most companies would reduce 
their R&D regardless of their size) at the two lowest policy options. This may put SMEs at a 
disadvantage against large companies in the future; R&D is the means to develop novel methods 
to improve efficiency and reduce costs for companies. 

•  Overall SME’s may be at a competitive disadvantage compared with large enterprises as costs 
make up a higher proportion of their turnover than large companies which are more likely to 
absorb the costs. 

Minimising the negative impacts on SMEs 

•  The policy option where a transitional period of 6 years before the option of the OEL 70 ng/m³ 
will be introduced allows companies to plan and finance their investments in RMMs over the 
six-year period. The is will be particularly important for SMEs. 

•  Based on first year costs as a percentage of turnover for sectors with a transitionary period, 
C19.1 and C20.14 are sectors with high first year costs for remaining SMEs, and a high 
proportion of discontinuations at 70ng/m3. For C19.1 the majority of the sector is estimated to be 
made up of SMEs, and for C20.14 approximately half of all companies are SMEs. 

•  The transitionary period is expected to reduce the number of SMEs discontinuing (and therefore 

unemployment) for SMEs in these sectors.  

3.  1,4-DIOXANE 

Identification of affected businesses 

Table 129 – 1,4-dioxane-related SME test 

•  95% of the affected companies are small companies and 3% are medium sized companies. 

•  The share of SMEs is similar across all the most affected sectors (between 88% and >99%) with 

the exception of the sector that produces 1,4-dioxane. 

Consultation with SME stakeholders 

•  SMEs have been consulted as part of stakeholder consultation. The share of SME respondents is 
100% in the stakeholder survey conducted for this study (40% of responses are from small 
companies, 60% of responses are from medium-sized companies). SMEs are thus well 
represented.  

•  SME stakeholders express concern that the lowest OEL option, two of the five respondents 

expect moderate or significant competitiveness impacts from the OEL option of 7.3 mg/m³ (2 
ppm).   

302 

 
 
 
 
 
 
Assessing the impacts on SMEs 

One indicator for assessing the impacts on SMEs is the share of first year costs in annual turnover. While 
there is no specific agreed benchmark for what significant impacts are, when the indicator is above 5%, 
then it will be considered significant in this study. The table presents how many sectors where the 
indicator is above 5% for small and medium companies. This indicates that it is only small companies 
that face more significant challenges for the lowest OEL or lowest OEL/BLV combination in the 
following sector: C20.1, C20.3 and C20.5 chemicals, where this indicator exceeds 14% for both lowest 
OEL or lowest OEL/BLV combination. 

OEL 

Share of sectors where first year costs exceed 5% of annual 
turnover 

Small sized companies 

Medium sized companies 

7.3 mg/m3 

20 mg/m3 

OEL 

17% (1 sector) 

0% 

0% 

0% 

Share of sectors where first year costs exceed 5% of annual 
turnover 

Small sized companies 

Medium sized companies 

7.3 mg/m3 and 45 mg 
HEAA in urine/g Creatinine 

20 mg/m3 and 108 mg 
HEAA in urine/g Creatinine 

17% (1 sector) 

0% 

0% 

0% 

Minimising the negative impacts on SMEs 

None of the policy measures have special provisions for SMEs.  

4. 

ISOPRENE 

Identification of affected businesses 

Table 130 – Isoprene-related SME test 

66% of the affected companies are small companies and 9% are medium sized companies.  

The share of SMEs is different between the two sectors in this analysis as no SMEs are associated with the 
C19.2 Manufacture of refined petroleum products sector. 

Consultation with SME stakeholders 

303 

 
 
 
 
 
 
 
 
 
•  SMEs have been consulted as part of stakeholder consultation. The share of SME respondents is 

33% in the stakeholder survey conducted for this study. While this share is lower than the share of 
SMEs in affected companies, SMEs are still well represented.  

•  SME stakeholders expressed no concern for any of the policy options, in relation to their 

competitiveness.   

Assessing the impacts on SMEs 

One indicator for assessing the impacts on SMEs is the share of first year costs in annual turnover. While 
there is no specific agreed benchmark for what significant impacts are, when the indicator is above 5%, 
then it will be considered significant. The table presents how many sectors where the indicator is above 5% 
for small and medium companies. This indicates that it is only small companies that face more significant 
challenges for the lower OELs. 

Policy option 

Share of sectors where first year costs exceed 5% of 
annual turnover 

Small sized companies 

Medium sized companies 

8.5 mg/m3 

0% 

0% 

Minimising the negative impacts on SMEs 

None of the policy measures have special provisions for SMEs. 

5.  WELDING FUMES 

Identification of affected businesses 

Table 131 – Welding fumes-related SME test 

•  An estimate of the affected companies is that 97.6% are small companies and 1.9% are medium 

sized companies.  

•  The sectors with the highest numbers of exposed workers in SMEs are estimated to be F43, F41, 

G45, C25 and C33.  

Consultation with SME stakeholders 

304 

 
 
 
 
 
 
 
•  SMEs have been consulted as part of stakeholder consultation. The share of SME respondents is 

64% of the stakeholder survey conducted for the purpose of this impact assessment. Although this 
share is lower than the share of SMEs in affected companies or SMEs as a share of enterprises with 
exposed workers, SMEs are still well represented.  

•  A large limitation is that there were no responses from the construction sector which is estimated to 
include approximately half of exposed workers employed by SMEs (F41, F43). Also 55% of the 
survey responses were from Germany, so the responses are unlikely to be representative of the 
EU27.  

•  The most common estimate by SMEs for the initial investment to comply with policy option 2  was 
€10,000 – 100,000, this compares with an equivalent estimate of more than €100,000 for large 
enterprises247. At the time of the survey, policy option 2 was not fully defined, so these estimates 
may not be accurate. 

•  However, key stakeholders interviewed (July 2023) identified that worker protection is often weaker 
in SMEs than in larger enterprises, and that there is likely to be a greater need for SMEs to invest in 
additional RMMs and/or use RMMs they already have more effectively to protect their workers. 

Assessing the impacts on SMEs 

SMEs have limited funds to invest in RMMs, so are more likely to need: 

•  To use their R&D budget to invest in RMMs; 

•  To pass on additional costs to consumers through price increases; 

•  To potentially consider options to avoid using CMRs in welding which could reduce the variety of 

products they sell; and 

•  To potentially avoid generating welding fumes by avoiding welding completely, which could reduce 

the quality (strength and robustness) of their products although this is considered unlikely. 

Minimising the negative impacts on SMEs 

The possible revision of the SLIC guidance on welding fumes might include specific provisions to support 
SMEs in complying with their obligations laid down in the CMRD.  

247 The study team believes this is due to large enterprises expecting to install factory-wide extraction systems. 

305