COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE 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) 193 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE 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) 192 final}  
 
 
1.  NEED FOR ACTION  

1.1.  Why? What is the problem being addressed?  

Cancer  remains  the  first  cause  of  work-related  death  in  the  EU,  followed  by  cardiovascular 
diseases.  Every  year,  according  to  estimates  about  80,000  people  in  the  EU  lose  their  lives 
due to exposure to carcinogens at the place of work1.  

To improve the prevention of occupational diseases in the EU, the Commission is pursuing a 
continuous  update  of  the  Carcinogens,  Mutagens  and  Reprotoxic  substances  Directive 
2004/37/EC2  (‘CMRD’).  This  revision  process  contributes  to  further  reduce  prevalence  of 
occupational diseases in the EU by improving prevention, a key objective of the EU strategic 
framework on health and safety at work 2021-20273 (‘EU OSH strategic framework’). 

For this 6th revision of the CMRD, the Commission, after discussions with the members of the 
Advisory Committee on Safety and Health at Work’s (ACSH) Working Party on Chemicals, 
has  prioritised  the  following  5  substances,  groups  of  substances  or  process-generated 
substances for possible action:  

•  Setting limit values for:  cobalt and inorganic cobalt compounds, polycyclic aromatic 

hydrocarbons (‘PAHs’), 1,4-dioxane, and isoprene; and 
Inclusion in the scope of the CMRD via its Annex I: welding fumes. 

• 

According to the evidence gathered4, more than 2.6 million workers in the EU are exposed to 
one of these 5 substances. In case of no action at EU level, it would result in more than 29,000 
lung cancer cases and 27,000 non cancer cases5 over the next 40 years.  

Workers,  businesses  and  Member  States  are  particularly  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 value6  derived by 
the  European  Chemicals  Agency’s  (‘ECHA’)  Risk  Assessment  Committee  (‘RAC’)  in  its 
opinion7,  suggesting  that  the  current  prevention  of  occupational  exposure  to  isoprene  is 
sufficient. 

1.2.  What is the initiative expected to achieve?  

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 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 
3 COM/2021/323 final, op. cit. 
4 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. 
5 4,365 restrictive lung diseases, 14,152 upper airway irritations, 38 developmental toxicity cases, 3,157 cases of 
male infertility, 633 liver effects cases, 497 kidney effects cases and 4,381 cases of effects in nasal cavity 
6 Level of exposure that is considered to be safe (health-based) for a chemical substance in the air of a 
workplace. 
7 RAC (2022), Opinion on scientific evaluation of occupational exposure limits for isoprene, available at: 
11c4dd13-2117-8cd1-83d6-44fc9e591b8f (europa.eu) 

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This initiative aims to comply with the legal obligations laid down in Article 16 of the 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 framework. This initiative will pursue 
the following specific objectives:  

•  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; and 

•  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. 

1.3.  What is the added value of action at EU level?  

By acting at EU level, this initiative will:  

• 

improve  clarity  and  enforcement:  establishing  limit  values  for  additional  substances 
or  groups  of  substances  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.  Adding  welding  fumes  in  Annex  I  of  the  CMRD  will  also  contribute  to 
address the lack of clarity on the possible dangerousness of these fumes for workers, 
and therefore the lack of appropriate risk management measures (‘RMMs’).     

•  ensure a similar minimum level of protection across the EU: the national limit values 
for  cobalt  and  its  inorganic  compounds,  PAHs  and  1,4-dioxane  vary  considerably 
between Member States, where they exist. For instance, the national limit values for 
cobalt  range  from  10  to  500  µg/m³  for  those  Member  States  that  have  them.  In  the 
absence of any action at the EU level, very different levels of workers’ protection are 
likely to persist.  

•  Contribute  to  a  more  levelled  playing  field:  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  helps  to  provide  a  level  playing  field  for  industry  by  reducing  the 
scope  for  divergences  and  enhancing  certainty  that  there  is  a  core  definition  or 
enforceable  limit  value  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.  

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•  Reduce 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.  

2.  POLICY OPTIONS  

2.1.  What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a 

preferred choice or not? Why?  

2.1.1.  Substances prioritised for the setting of limit values  

For each substance subject to the setting of limit values (cobalt and its inorganic compounds, 
PAHs  and  1,4-dioxane),  which  have  currently  no  binding  limit  value  at  EU  level8,  several 
policy options for limit values were identified. These policy options always include the limit 
values derived by RAC (scientific experts), when they exist, and those recommended by the 
tripartite ACSH (stakeholders).  

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  establishing  risk-based  limit  values  for  non-threshold  carcinogens9  and  the 
existing national limit values.  

With  regard  to  isoprene,  the  evidence  gathered  indicates  the  current  and  future  levels  of 
workers’ exposure are already lower than the health-based limit value derived by RAC in its 
opinion.  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. Therefore, no policy option was 
considered for this specific substance. 

2.1.2.  Welding  fumes,  process-generated  substance  subject  to  inclusion  in  Annex  I  of  the 

CMRD 

The  evidence  gathered10  indicates  that  some  employers  are  not  aware  that  their  welding 
processes  may  release  fumes  containing  carcinogens,  mutagens  or  reprotoxic  substances. 
These employers may therefore ignore to what extent exposure to welding fumes is dangerous 
for  their  workers.  For  that  reason,  the  policy  option  considered  for  welding  fumes  is  their 

8 1,4-dioxane has a limit value of 73 mg/m3 set in the Chemical Agents Directive. However, this limit value is 
indicative, not binding. Following the recent EU reclassification of 1,4-dioxane as carcinogen, it now falls under 
the scope of the CMRD and requires the setting of a binding limit value.  
9 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  
10 RPA (2024), op. cit.  

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inclusion in Annex I to the CMRD in order to improve legal clarity and raise awareness of the 
possible dangerousness of welding fumes.  

2.1.3.  Preferred choices  

Based on a thorough impact assessment, limit values recommended by the ACSH have been 
retained as preferred options for cobalt and inorganic cobalt compounds, PAHs, 1,4-dioxane 
and  welding  fumes,  as  they  represent  the  best  balance  in  terms  of  effectiveness,  efficiency, 
and coherence.  

2.2.  Who supports which choice?  

Within the framework of the formal two-stage consultation, social partners supported the list 
of  priority  substances  to  be  addressed  in  the  6th  revision  of  the  CMRD.  Governments, 
employers  and  workers’  representatives  within  the  ACSH  support  the  preferred  options  for 
cobalt  and  its  inorganic  compounds,  PAHs,  1,4-dioxane  and  welding  fumes,  including  the 
transitional  periods  proposed  to  mitigate  technical  or  economic  challenges  for  employers 
regarding cobalt and its inorganic compounds, and PAHs.  

3.  IMPACTS OF THE PREFERRED OPTION  

3.1.  What are the benefits of the preferred options?  

With  regard  to  workers,  the  preferred  options  for  the  4  substances  are  expected  to  prevent 
about  1,700  lung  cancer  cases  and  19,000  non-cancer  cases  over  the  next  40  years.  These 
avoided ill-health cases represent savings amounting to up to €1.16 billion11. 

The  preferred  options  would  also  result  in  benefits  for  businesses  in  terms  of  reduction  of 
absenteeism, productivity losses and insurance payments for about €7 million over the next 40 
years. The estimated benefits for businesses do not include some positive impacts such as the 
improved legal clarity. Furthermore, the preferred options would also bring benefits to public 
authorities in  terms  of  costs savings related to  healthcare expenditures  amounting  to  €26.65 
million  and avoided costs of setting  limit  values following national  processes, which would 
represent up to €3.75 million.  

3.2.  What are the costs of the preferred options?  

The  total  adjustment  costs  for  businesses  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 

11 Application of WTP (willingness to pay) values to each case (= method 1).  

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period. 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. For 
most  of  businesses,  these  costs  would  represent  less  (and  often  far  less)  than  1%  of  their 
turnover.  It  is  worth  noting  that  the  estimates  related  to  the  number  of  discontinuations  are 
likely to be overestimated.  

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  the  protection  of  firefighters  against  exposure  to  PAHs.  The 
remaining 5% relates to transposition costs. 

3.3.  How will businesses, SMEs and micro-enterprises be affected?  

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,  SMEs  are  likely  to  be 
more impacted by the package of preferred options compared to larger enterprises.  

Furthermore,  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. The transitional measures contribute to avoid imposing financial constraints in a way 
which would hold back the creation and development of SMEs. 

3.4.    Will there be significant impacts on national budgets and administration?  

Overall,  public  authorities  are  expected  to  spend  €66  million  over  40  years  (approx.  €1.65 
million per year). At the level of Member States, these costs are likely to have limited impacts 
on  national  budgets  and  administration.  Furthermore,  these  costs  will  be  mitigated  by  the 
benefits  arising  from  the  preferred  options  (around  €30  million),  in  particular  related  to  the 
healthcare cost savings.  

3.5.  Will there be other significant impacts?  

The  package  of  preferred  options  might  have  some  negative  indirect  impacts  on  the  green 
transition or the digital transition due to discontinuations in key sectors, such as 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.  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.  Therefore,  the 
overall indirect impact on the green and the digital transition should be limited.  

4.  FOLLOW-UP 

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4.1.  When will the policy be reviewed?  

The  effectiveness  of  the  proposed  CMRD  revision  would  be  measured  in  the  framework  of 
the evaluation of the EU Occupational Health and Safety Directives as foreseen in the Article 
17a of the Directive 89/391/EEC12. 

12 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  

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