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: 2016-05-13
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, 13.5.2016  SWD(2016) 153 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(2016) 248 final} {SWD(2016) 152 final}  
 
 
Impact  assessment  on  Proposal  for  a  Directive  amending  the  Carcinogens  and  Mutagens  Directive  to  identify 
new 'process generated substances' and establish/revise binding Occupational Exposure Limit Values 

Executive Summary Sheet 

A. Need for action 

Why? What is the problem being addressed? 
Exposure to some chemical agents in the workplace can cause cancer, which is the first cause of work-related 
deaths  in  the  EU.  To  protect  workers  against  such  risks,  the  EU  has  adopted  the  Carcinogens  and  Mutagens 
Directive (CMD), which sets out steps to be taken to eliminate or limit exposure to carcinogenic chemical agents 
and includes Occupational Exposure Limit (OEL) values. However, the CMD is out of date as it does not take 
into  account  the  available  scientific  evidence.  The  Commission  has  conducted  a  scientific  and  economic 
assessment  of  25  priority  chemical  agents  to  which  around  20  million  workers  are  exposed  in  the  EU.  Out  of 
those  13  agents,  for  which  data  sets  are  ready,  are  covered  in  the  impact  assessment.  Member  States  have 
introduced OELs for some of them but they are highly divergent and sometimes set too high to protect workers. 

Occupational cancer impacts the economy at large, reducing labour supply (either temporarily or permanently), 
decreasing  labour  productivity  and  increasing  the  burden  on  public  finances  through  avoidable  public 
expenditure on health care, disability benefits, pensions for early retirement, and other benefits. For the workers 
and their families, cancer results not only in substantial quality of life losses, but also in direct health care costs 
and  indirect  loss  of  present  and  future  earnings.  For  business,  occupational  cancer  implies  staff  replacement 
costs, productivity losses and the need to pay higher wages to compensate for the higher occupational risk, what 
affects their competitiveness.    

What is this initiative expected to achieve? 
The initiative pursues three objectives: 

  To reduce EU workers occupational exposure to carcinogenic chemical agents 
  To increase the effectiveness of the EU framework 
  To ensure more clarity and a better level playing field for economic operators 

What is the value added of action at the EU level?  
The current differences in Member States regarding national OELs for the identified carcinogens do not provide 
a  minimum  basis  of  protection  for  all  EU  workers  against  the  risks  arising  from  occupational  exposure.  The 
current situation also creates an unlevelled playing field for firms as those operating in Member States with less 
protective  OELs  have  a  competitive  advantage.  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  TEU 
Article 5(3).   

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 
choice or not? Why?  
Following  discussions  by  scientists,  employers,  workers  and  Member  States  representatives  suggestions  for 
OELs  have  been  developed  for  the  13  chemical  agents.  For  most  of  them  more  stringent  and  less  stringent 
options were also considered. For some agents (e.g. chromium (VI) compounds, hardwood dust and respirable 
crystalline silica (RCS)) more significant impacts were identified. For others (e.g. 2 nitropropane and acrylamide), 
the estimated costs/benefits of the baseline (no action) and of setting an EU OEL are closely matched.  
Banning the carcinogens from the workplace was considered but discarded as disproportionate. While REACH 
and CMD are complementary, workplace exposure to chemical carcinogens can be most efficiently regulated by 
the CMD. Setting sector, industry or use-specific OELs had to be discarded as the current legal framework does 
not  provide  a  legal  basis  for  such  provisions.  Non-legislative  policy  options,  such  as  developing  guidance  and 
other  implementation  support  for  CMD  or  reliance  on  self-regulation  have  also  been  considered.  It  has  been 
decided however that those measures alone would not be able to substantially contribute to the solving of the 
identified  problems.  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  including  RCS  into  the  CMD  list  of  process  generated  substances  and  adopting  OELs  at  values  they 
recommend. In general, where positions differed, workers pushed for lower (more 'protective') and employers for 
higher  (less  costly  to  implement)  OEL  values.  The  inclusion  of  RCS  as  a  process-generated  occupational 
carcinogen  has caused concern  for some sectors  of  industry  both  regarding  the standard of  risk  management 
this  may  entail  and  also  regarding  stigmatisation  of  the  bulk  commodity  equivalent  (i.e.  sand  and  other  silica 

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products) as 'cancer-causing'.  These factors are discussed in the analysis. 

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise main ones)? 
The  benefits  of  the  retained  policy  options  will  consist  in  a  substantial  reduction  of  work-related  cancer  cases 
and  deaths.  A  conservative  estimate  concludes  that  around  100,000  lives  could  be  saved  as  a  result  of  the 
initiative.  Workers  and  their  families  will  experience  less  quality  of  life  losses  caused  by  work-related  cancer. 
There  will  also  be  direct  and  indirect  individual  healthcare  cost  savings  in  relation  to  cancer.  Social  security 
systems will benefit from a reduction of cancer treatment costs, together with reduced expenditure on associated 
inactivity/early  retirement  and  compensation  for  occupational  diseases.  Employers  are  likely  to  benefit  from 
reduced  productivity  losses,  arising  from  loss  of  workers  due  to  work-related  ill-health  and  their  replacement 
costs.  A  study  undertaken  on  behalf  of  Commission  services,  shows  the  main  benefits  are  expected  from  the 
introduction  of  the  OEL  at  0.1  mg/m3  for  RCS  and  at  0.025  mg/m3  for  chromium  (VI)  compounds.  As  regards 
RCS it is expected that, over the period 2010-69, around 99,000 cancer cases will be avoided, corresponding to 
a monetary value between € 34 billion and 89 billion. Regarding chromium (VI), the preferred option will lead to 
around  1,800  avoided  cases  over  the  same  period  (€591  million-1,7  billion).  The  main  monetary  benefits  in 
relation to the introduction of an OEL under the option retained for the other agents are: Hardwood Dust (€12-54 
million);  Vinyl  chloride  (€1-4  million);  o-Toluidine  (€1.3-10.1  million);  Hydrazine  (€0.01-0.05  million);  Refractory 
ceramic fibres (€1.1-3.4 million). 

What are the costs of the preferred option (if any, otherwise main ones)? 
For  some  carcinogens,  the  retained  option  will  affect  operating  costs  for  enterprises  which  will  have  to  put  in 
place  additional  protective  and  preventive  measures.  This  will  be  in  particular  the  case  for  Chromium  (VI) 
compounds  and  RCS.  As  regards  RCS,  the  costs  to  industry  of  anticipating  investment  to  comply  with  an 
exposure  level  of 0.1  mg/m3  are  estimated  to  be  at  €3.5  billion until  2069.  For  the remaining carcinogens,  the 
impact on operating costs for business (including small and medium enterprises) will be minimal as only small 
adjustments  will  be  needed  to  ensure  full  compliance.  The  package  of  retained  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? 
Businesses would profit from a greater clarity and a more levelled playing-field. For many of the agents covered 
in  this  impact  assessment,  OELs  (some  at  different  values  between  Member  States)  exist  already  at  national 
level.  Establishing  the  OELs  foreseen  in  this  initiative  should  have  no  impact  on  those  businesses  situated  in 
those  EU  Member  States  where  the  national  OELs  are  either  equal  or  lower  (more  strict)  than  the  proposed 
values. No lighter regimes were foreseen for SMEs, which are not exonerated from the CMD obligations as this 
would lead to an unequal protection of workers depending on the company size. The main impact in situations 
where  higher  exposures  are  expected  to  occur  will  be  for  SMEs  were  workers  are  exposed  to  RCS  and 
Chromium (VI). 

Will there be significant impacts on national budgets and administrations? 
While the current situation imposes substantial economic costs on workers due to their exposure to hazardous 
substances,  the  retained  option  also  mitigates  'knock  on'  financial  losses  for  Member  States'  social  security 
systems. Administrative and enforcement costs for public administrations will differ according to present status of 
each chemical agent in each MS, but are not expected to be significant. In addition, setting EU OELs will limit 
the need to conduct scientific analysis separately by Member States. 

Will there be other significant impacts? 
Implementing  the  retained  option  would  have  a  positive  impact  on  competition  within  the  internal  market.  EU-
wide OELs for the agents concerned by this initiative will reduce competitive distortion between firms located in 
Member States with different national OELs. In addition, as the proposed OELs are similar to those prevailing in 
most  EU  trade  partners,  there should not  be  a  significant  impact on  the external  competitiveness  of  EU firms. 
The  impact on fundamental rights is positive  - in particular with regard to article 2 (Right to life) and article 31 
(Right to fair and just working conditions which respect his/her health, safety and dignity). 

D. Follow up 

When will the policy be reviewed? 
The effectiveness of the proposed CMD revision would be measured in the framework of the next evaluation of 
the  EU  Occupational  Health  and  Safety  (OSH)  framework  as  foreseen  in  the  Article  17a  of  the  Directive 
89/391/EEC. It should be noted that monitoring and evaluation mechanisms might be modified in the meantime 
as a result of the ongoing ex-post evaluation of the OSH acquis (covering the period 2007-2012).  

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