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 on the protection of workers from the risk related to exposure to carcinogens or mutagens at work
Date: 2018-04-05
Institutions: Directorate-General for Employment, Social Affairs and Inclusion, European Commission
Subjects: beryllium, cadmium, cancer, carcinogenic substance, chemical compound, health risk, occupational disease, occupational health, safety standard, semi-metal

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   EUROPEAN COMMISSION  Brussels, 5.4.2018  SWD(2018) 87 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 on the protection of workers from the risk related to  exposure to carcinogens or mutagens at work  {COM(2018) 171 final} - {SWD(2018) 88 final}  
 
 
Executive Summary Sheet 

Impact  assessment  on  further  Proposal  to  amend  the  annexes  to  the  Carcinogens  and  Mutagens 
Directive 2004/37/EC. 

A. Need for action 

Why? What is the problem being addressed?  
Exposure  to  carcinogens  and  mutagens  at  the  workplace  can  cause  cancer,  which  is  the  main  work-related 
health  problem  in  the  EU-28,  as  well  as  other  significant  non-cancer  health  problems.  To  contribute  to  the 
protection of workers from such risks, the EU has adopted the Carcinogens and Mutagens Directive 2004/37/EC 
(CMD). It lays down requirements in this area to eliminate or reduce exposure, including occupational exposure 
limit  values  (OELs).  However,  CMD  needs  to  be  regularly  updated  based  on  available  information,  including 
scientific and technical data. Two legislative proposals updating the CMD - COM(2016)248 and COM(2017)11, 
addressing together 20 carcinogens, have been proposed. The first amendment has  already been adopted by 
the co-legislators – Directive (EU)2017/2398. This impact assessment accompanying the third proposal covers 
further five chemical agents to which around 1 000 000 workers are exposed at their workplaces.  

What is this initiative expected to achieve?  
The initiative pursues three specific objectives: 
  To reduce occupational exposure to carcinogens and mutagens in the European Union; 
  To increase the effectiveness of the EU framework by updating it on the basis of scientific expertise; 
  To achieve a more balanced protection of workers across the EU against carcinogens while ensuring more 

clarity and level playing field for economic operators. 

What is the value added of action at the EU level?  
Establishing new or revising the existing OELs in Annex III to the Directive will provide more clarity for employers 
and enforcers, thus  facilitating and improving compliance and enforcement of the provisions of the CMD, and 
thereby workers protection. By lowering existing and closing gaps of non-existing national OELs, EU action can 
contribute to further enhancing the minimum basis of protection for all EU workers in this area and to level the 
playing field among EU businesses. Action taken by Member States alone cannot address these concerns, and 
consequently EU level action to achieve this objective appears necessary and in line with Article 5(3) of the TEU. 

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 
choice or not? Why?  
A  number  of  options  were  identified  and  discarded  for  the  covered  carcinogens.  For  example,  banning  them 
from  the  workplace  was  considered  disproportionate  and  reliance  on  non-legislative  guidance  or  on  self-
regulation  would  not  be  able  to  substantially  contribute  to  the  solving  of  the  identified  problems.  Proposals  for 
legislative  options  with  regard  to  five  carcinogens  (OELs  in  Annex  III)  were  based  on  the  outcomes  of 
discussions by scientists, employers, workers and Member States' representatives. For most of the carcinogens 
more  stringent  and  less  stringent  options  were  also  analysed.  The  retained  options  are  considered 
complementary  and  to  add  value  to  existing  REACH  measures  in  the  relevant  cases.  Legal  certainty  for 
stakeholders  is  best  achieved  through  clear  listing  of  chemical  agents  under  the  CMD  together  with  OELs 
allowing management of the risk of occupational exposure to chemical carcinogens. 

Who supports which option?  
Social  Partners  and  Member  States,  represented  in  the  Advisory  Committee  on  Safety  and  Health  at  Work, 
support  all  of  the  retained  options.  To  mitigate  technical  or  economic  challenges  for  employers,  transitional 
periods are envisaged for two substance groups (cadmium and its inorganic compounds, beryllium and inorganic 
beryllium compounds) for all sectors, and for one substance group (arsenic acid and its salts, inorganic arsenic 
compounds) for the copper smelting sector. 

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C. Impacts of the preferred option 

What are the benefits of the preferred option?  
The  benefits  of  the  preferred  policy  option  will  consist  in  increased  protection  for  over  1 000 000 EU 
workers and prevention of over 22 000 cases of work-related ill health.  
Consequently, it will lead to better quality of life for workers and their families, and reduced direct and indirect 
individual healthcare costs. Social security systems will benefit from a reduction of treatment costs and reduced 
expenditure  on  associated  inactivity/early  retirement  and  compensation  for  occupational  diseases.  Employers 
are likely to benefit from reduced absenteeism and productivity losses. Last but not least, setting EU OELs will 
improve clarity for employers and enforcers. 
A  study  undertaken  on  behalf  of  the  Commission  shows  that  the  highest  expected  benefits  for  different 
stakeholders  are  the  following:  for  workers  EUR 1  to  5  billion,  as  well  as  EUR 181 million  for  administrations, 
from the introduction of an OEL for formaldehyde; and for businesses EUR 15 million from the introduction of an 
OEL for beryllium. 

What are the costs of the preferred option?  
For some carcinogens, the preferred option will entail operating costs for enterprises which will have to put in 
place additional protective and preventive measures. This will be in particular the case for formaldehyde and 
cadmium and its inorganic compounds, where the total costs to industry of the retained option over a 60 year 
period are estimated to reach EUR 1.72 billion for formaldehyde and EUR 447 million for cadmium.  
However, in case of formaldehyde the number of companies is very high and in case of cadmium mainly large 
companies would be affected. Therefore, the cost per company in relative terms for both substances is expected 
to be modest. The package of preferred options will not impose any additional information obligations or lead to 
an increase in administrative burdens on enterprises and is not likely to generate any significant environmental 
costs. 

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

For cadmium and arsenic compounds, SMEs are not significantly represented in the relevant industries, contrary 
to  beryllium,  formaldehyde  and  4,4'-Methylene-bis(2-chloroaniline)  (MOCA).  The  analysis  shows  that  costs 
which  will  be  incurred  by  SMEs  are  affordable  for  the  companies  concerned.  The  most  significant  costs  are 
foreseen for SMEs dealing with formaldehyde and beryllium and in particular, for those companies which have 
not yet made the investments to protect workers either through closed systems or substitution. However, costs 
for SMEs remain well below 1% of their turnover, and no SME closures or employment effects are expected at 
the proposed OELs. . 

Will there be significant impacts on national budgets and administrations?  
Additional administrative costs and enforcement costs might be incurred by enforcing authorities. However, it is 
not expected for the costs to be significant. At the same time, setting OELs at EU level will save costs to develop 
OELs  at  national  level.  The  retained  option  should  also  contribute  to  mitigate  financial  loss  of  Member  State 
social security and health care systems by preventing ill-health.  

Will there be other significant impacts?  
The  retained  options  would  have  a  positive  impact  on  competition  within  the  internal  market  by  decreasing 
competitive  differences  between  firms  operating  in  Member  States  with  different  national  OELs.  The  retained 
options  should  not  have  a  significant  impact  on  the  external  competitiveness  of  EU  firms.  In  most  cases,  the 
retained  options  fit  into  the  lower  range  of  equivalent  measures  established  in  non-EU  countries  –  suggesting 
that these measures are achievable, reflect available good practice, and are relatively ambitious in aiming to set 
internationally  high  standards  of  worker  protection.  The  impact  on  fundamental  rights  is  positive  -  in  particular 
with regard article 2 (Right to life) and article 31 (Right to fair and just working conditions which respect his/her 
health, safety and dignity). 

When will the policy be reviewed?  

D. Follow up 

The effectiveness of the proposed CMD revision would be measured in the framework of the evaluation of the 
EU Occupational Health and Safety framework as foreseen in the Article 17a of the Directive 89/391/EEC. 
The next evaluation exercise could possibly cover the period of 2017-2022. 

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