COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.
Date: 2020-09-22
Institutions: Directorate-General for Employment, Social Affairs and Inclusion, European Commission
Subjects: cancer, carcinogenic substance, health risk, occupational disease, occupational health, safety standard

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   EUROPEAN COMMISSION  Brussels, 22.9.2020  SWD(2020) 184 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT  Accompanying the document Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.   {COM(2020) 571 final} - {SEC(2020) 302 final} - {SWD(2020) 183 final}  
 
 
Executive Summary Sheet 

Impact  assessment  on  Proposal  for  a  Directive  amending  Directive  2004/37/EC  on  the  protection  of  workers 
from the risk related to exposure to carcinogens or mutagens at work.  

A. Need for action 

Why? What is the problem being addressed?  
The  exposure  of  workers  to  carcinogens  and  mutagens  represents  a  significant  risk  to  workers’  health. 
According to EU-OSHA1, 52% of annual occupational deaths in the EU are attributed to cancer. For this reason, 
the  Commission  continues  its  process  of  updating  the  Carcinogens  and  Mutagens  Directive  (CMD)2  by 
proposing  this  fourth  batch  of  additional  Occupational  Exposure  Limits  (OELs).  This  is  in  line  with  the  CMD, 
which requires that OELs must be set for all those carcinogens and mutagens for which this is possible in the 
light of the available information.  

More  than  1  million  EU  workers  are  currently  exposed  to  the  three  substances  addressed  in  this  initiative, 
namely  acrylonitrile,  nickel  compounds  and  benzene.  In  case  of  no  action  at  the  EU  level,  the  occupational 
exposure to these three substances would lead to almost 2000 cancer and other work-related illness cases over 
the next 60 years.  

What is this initiative expected to achieve?  
The main general objective of this initiative is to further strengthen the workers’ right to a high level of protection 
of their health and safety at work and to prevent death caused by work-related cancer and other health problems 
caused  by  these  three  substances.  In  order  to  support  this  general  objective,  this  initiative  will  pursue  three 
specific objectives:  

  Further improving protection from occupational exposure to carcinogens and mutagens in the EU;  
 
Increasing the effectiveness of the EU legal framework by updating it on the basis of scientific expertise;  
  Ensuring more clarity, facilitating implementation and contributing towards a better level playing field for 

economic operators by adopting minimum requirements at the EU level.  

What is the value added of action at the EU level?  
Establishing  new  or  revised  OELs  in  the  CMD  will  enable  to  ensure  a  similar  minimum  level  of  protection  for 
workers  across  the  EU.  Indeed,  in  the  absence  of  EU  wide  OELs,  as  in  the  case  of  nickel  compounds  and 
acrylonitrile,  some  Members  States  have  not  set  any  national  OELs  or  have  adopted  very  different  levels, 
leading to high disparities in terms of protection of workers from the exposure to these substances. With regard 
to benzene, even if an EU OEL exists, workers’ protection varies as some Member States have adopted a lower 
national OEL.  

In addition to this similar minimum level  of protection across the EU, this initiative  will  also  improve clarity  and 
enforcement,  contribute  to  a  better  level  playing  field  for  the  economic  actors  in  the  sectors  using  those 
substances  and  avoid  any  work  duplication  by  eliminating  the  need  for  Member  States  to  conduct  their  own 
scientific analysis to establish OELs.  

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 
choice or not? Why?  
Several options have been discarded as they were considered disproportionate or less effective in reaching the 
objectives of this initiative. Among these options are the ban on the use of the carcinogenic chemical agents at 
work, market-based instruments (subsidies, tax breaks, etc.), industry self-regulation and guidance documents.  

Setting new or revised EU wide OELs in the CMD have been retained as the most appropriate option. Several 
OELs scenarios have been assessed, including OELs agreed by the tripartite Advisory Committee on Safety and 

1  EU-OSHA  (2017),  An  international  comparison  of  the  cost  of  work-related  accidents  and  illnesses,  available  at: 
https://osha.europa.eu/en/publications/international-comparison-cost-work-related-accidents-and-illnesses/view 
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.  Available  at:  https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:32004L0037 

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Health  at  Work  (ACSH),  which  take  into  account  scientific  recommendations  as  well  as  socio-economic  and 
feasibility  issues.  The  ACSH  is  composed  of  representatives  of  Governments,  Employers  and  Workers.  In 
addition  to  OELs  agreed  by  the  ACSH,  lower  and  higher  limit  value  scenarios  have  been  considered  for  each 
substance.   

Based  on  a  thorough  impact  assessment,  OELs  recommended  by  the  ACSH  have  been  retained  as  the 
preferred  options  as  they  represent  the  best  scenarios  in  terms  of  effectiveness,  efficiency  and  coherence. 
These  retained  options  are  also  considered  complementary  with  the  existing  REACH  measures  for  each 
substance.  

Who supports which option?  
Within the framework of the formal two-stage consultation, Social Partners support the list of substances to be 
addressed in the fourth amendment of the CMD.  

Governments,  Employers  and  Workers’  representatives  within  the  ACSH  support  all  the  preferred  options, 
including  the  transitional  periods  proposed  to  mitigate  technical  or  economic  challenges  for  employers 
concerning the three substances.    

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise main ones)?  
The  main  benefits  arising  from  the  preferred  options  for  the  three  substances  consist  in  contributing  to  the 
protection of more than 1,000,000 workers by preventing more than 1700 cases of work-related illness over the 
next 60 years, including cancer. This reduction of occupational diseases will lead among others to less suffering 
of workers and their families and greater length, quality and productivity of their working lives.  

The  preferred  options  will  also  bring  benefits  to  business  by  reducing  absenteeism,  productivity  losses  and 
insurance  payments  for  an  estimated  amount  of  €7  million  over  the  next  60  years.  The  estimated  benefits  for 
business does not integrate some advantages like the improved legal clarity. Public authorities will also benefit 
from these preferred options as it will lead among others to decreased health care costs. The benefits for public 
authorities have been estimated to €5 million over the next 60 years.  

In addition to these economic and social benefits, the preferred option for benzene will lead to reducing fugitive 
or diffuse emissions in some sectors, which will have positive impacts on environment. The preferred options for 
acrylonitrile and nickel compounds should have no or very limited positive environmental impacts. 

What are the costs of the preferred option (if any, otherwise main ones)?  
Companies  will  have  to  make  investments  in  order  to  comply  with  the  preferred  options  as  well  as  spend 
additional  resources  to  monitor  the  exposure,  which  will  entail  operating  costs.  It  is  estimated  that  these 
expenses  could  reach  €14  billion  over  the  next  60  years.  However,  these  costs  should  be  sustainable  for  the 
majority of businesses compared to their turnover. Furthermore, transitional measures have been included in the 
preferred options package in order to mitigate challenges for employers but also to avoid job losses.   

Although companies may decide to pass on cost increases in some very specific cases, there will be no or very 
limited impacts in terms of prices for consumers.  

Public authorities will have to invest money when transposing these preferred options in their own legislation. It 
is estimated that transposition costs could reach €2.5 million.  

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

The  package  of  preferred  options  will  entail  operating  costs  for  companies,  which  will  have  to  put  in  place 
additional  protective  measures,  irrespective  of  their  size.  However,  compared  to  the  annual  turnover,  these 
investments are expected to be sustainable for the three substances. 

While  companies  using  acrylonitrile  are  mainly  large  companies,  SMEs  represent  a  large  proportion  of  the 
relevant  industries  dealing  with  nickel  compounds  and  benzene.  For  all  the  substances  considered  in  this 
initiative, the required investments for SMEs will represent a small share of the SMEs’ turnover over the next 60 
years. Only a very few number of SMEs concerned by the use of nickel compounds might face some difficulties 
to comply with the preferred option. For that reason, transitional periods aiming to mitigate the challenges have 
been included in the package of preferred options for all the substances.    

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Will there be significant impacts on national budgets and administrations?  
Additional  administrative  and  enforcement  costs  might  be  incurred  by  enforcing  authorities.  However,  it  is  not 
expected for the costs to be significant. The retained  option should  also contribute to mitigate financial loss of 
Member State social security and health care systems by preventing ill-health. The benefits for public authorities 
(almost €5 million) are expected to be higher than the costs (almost €2.5 million).  

Will there be other significant impacts?  
The  package  of  preferred  options  will  limit  the  scope  for  divergences  between  the  Members  States,  which  will 
contribute  to  a  level-playing  field  and  improve  further  the  functioning  of  the  internal  market.  These  preferred 
options will also have a positive impact on fundamental rights, especially with regard to the article 2 (Right to life) 
and 31 (Right to fair and just working conditions which respect his/her health, safety and dignity) of the Charter 
of Fundamental Rights of the European Union.  

D. Follow up 

When will the policy be reviewed?  
The effectiveness of the proposed CMD 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/EEC.  It  is 
suggested to make use of the next relevant evaluation exercise, after the end of the transposition period.  

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