COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE SUPPLEMENTARY 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: 2017-01-10
Institutions: Directorate-General for Employment, Social Affairs and Inclusion, European Commission
Subjects: cancer, carcinogenic substance, engine, health risk, occupational disease, occupational health, safety standard, used oil

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   EUROPEAN COMMISSION  Brussels, 10.1.2017  SWD(2017) 8 final   COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE SUPPLEMENTARY 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(2017) 11 final} {SWD(2017) 7 final}  
 
 
Impact assessment on further Proposal to amend the annexes to the Carcinogens and Mutagens Directive 

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.  Every  hour  in  EU28,  7-12  people  die  of  cancer  because  of  past  exposure  to  carcinogenic 
substances at work. 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  needs  to  be  updated.  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,  were  covered  in  an  earlier 
Commission  proposal  (COM(2016)248)  and  accompanying  impact  assessment  (IA)  (SWD(2016)152).  This 
supplementary IA applies the same methodology for the remaining substances. 

What is this initiative expected to achieve? 
The initiative pursues three specific objectives: 
  To further improve protection from occupational exposure to chemical carcinogens in the European Union; 
  To increase the effectiveness of the EU framework by updating it on the basis of scientific expertise;  
  To  ensure  more  clarity,  facilitate  implementation,  and  contribute  to  a  level  playing  field  for  economic 

operators by reducing divergences in national protection levels. 

What is the value added of action at the EU level?  
Compliance and  enforcement  of  the provisions  of the  CMD, and  thereby workers  protection,  can be  facilitated 
and  improved  by  identifying  and  listing  occupational  carcinogens  as  process-generated  substances  (PGS)  in 
Annex  I  to  the  Directive,  and  by  revising  existing  or  establishing  new  OELs  in  Annex  III  to  the  Directive.  By 
providing adequate common definitions of PGS and 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 against 
the  risks  arising  from  occupational  exposure  to  carcinogens.  Competitive  differences  between  firms  located  in 
Member  States  with  different  national  limit  values  may  be  reduced  through  the  establishment  of  clear  specific 
minimum requirements for worker protection in the form of EU-wide limit values for those agents. 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.  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 seven out of the 12 carcinogens (OELs in Annex III and/or inclusion in Annex I) 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 several 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. 
With regard to five remaining carcinogens (diesel engine exhaust, rubber process dust and fumes, beryllium and 
inorganic  beryllium  compounds,  4,4'-Methylene-bis-(2  chloraniline)  (MOCA)  and  hexachlorobenzene)  action 
through  amendment  of  the  CMD  is  withheld  at  this  stage  due  to  legal  considerations  or  absence  of  agreed 
position in the Advisory Committee on Safety and Health at Work. 

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. In general, where positions differed, workers pushed for more 'protective' and 
employers  for  'less  burdensome'  measures.  The  considered  inclusion  of  diesel  engine  exhaust  and  rubber 
process dust and fume as process-generated occupational carcinogens has not been fully agreed by the social 
partners, as a result of which no action is proposed at this stage with regard to those substances. 

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise main ones)? 
The  benefits  of  the  preferred  policy  option  will  consist  in  increased  protection  for  some  4  million  workers  and 
clarity  for  employers  and  enforcers.  Additional  reduction  of  work-related  cancer  cases  and  deaths,  reduced 

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quality of life losses for workers and their families, and direct and indirect individual healthcare cost savings are 
also  expected.  Social  security  systems  will  benefit  from  a  reduction  of  cancer  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.  A  study  undertaken  on  behalf  of 
Commission shows the main benefits are expected from the introduction of 'mineral oils as  used engine oils' into 
the CMD list of 'process generated substances', resulting in 880 saved lives, 90,000 less cancer cases, and a 
monetised  health  benefit  of  €0.3-1.6  bn  related  to  avoidance  of  health  costs  over  50  years.  Establishing 
inhalation  and  dermal  OEL  provisions  for  trichloroethylene,  is  expected  to  result  in  390  saved  lives  and  a 
monetised health benefit of €118-430m. 

What are the costs of the preferred option (if any, otherwise main ones)? 
For  some carcinogens,  the  preferred 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 trichloroethylene and 
mineral oils as used engine oils, where the total costs to industry of the retained option until 2069 are estimated 
to  range  between  €154-257m  for  trichloroethylene  and  €46m-918m  for  mineral  oils  as  used  engine  oils.  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. 

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How will businesses, SMEs and micro-enterprises be affected? 
Businesses would profit from a greater clarity.. No impact is expected on businesses situated in Member States 
where 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 
size. 
protection 
The most significant costs associated with the retained options relate to investment in closed systems for use of 
trichloroethylene,  where  SMEs  are  vulnerable  to  the  capital  cost  requirements  in  comparison  to  larger  firms. 
However,  according  to  the  terms  of  the  EU  solvent  emissions  directive  (1999/13/EC),  a  voluntary  European 
Chlorinated  Solvent  Association  responsible  use  charter,  and  notably  REACH  authorisation,  investment  in 
closed  systems  is  expected  to  already  have  occurred.  It  may  be  possible  for  firms  to  use  an  alternative 
substance  to  avoid  the  cost  of  a  closed  system,  or  to  increase  prices.  Ten  Member  States  have  currently 
established  equivalent  national  OELs  at  or  below  the  proposed  value  for  trichloroethylene,  indicating  that  it 
should be feasible for the sectors concerned to absorb the additional costs.  
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 package of preferred options 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  Member  State,  but  are  not  expected  to  be  significant.  In  addition,  cost 
saving is expected as setting EU OELs will limit the need to conduct scientific analysis separately by Member 
States. 

company 

Will there be other significant impacts? 
Implementing the package of preferred options would have a positive impact on competition within the internal 
market,  contributing  to  the  reduction  of  competitive  differences  between  firms  located  in  Member  States  with 
differing  national  protection  levels,  facilitating  compliance  and  enforcement,  resulting  in  improved  living  and 
working conditions and efficiency gains for businesses and national social security systems. The retained option 
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 at the same time 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). 

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 (OSH) framework as foreseen in the Article 17a of the Directive 89/391/EEC. 
The  next  ex-post  evaluation  exercise  (2012-2017)  would  define  the  baseline  values  (benchmark)  and  the 
evaluation  of  the  practical  implementation  of  the  proposed  amendments  could  possibly  be  based  on  the 
following period (2017-2022). 

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