COMMISSION STAFF WORKING DOCUMENT 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

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 10.1.2017  SWD(2017) 7 final   COMMISSION STAFF WORKING DOCUMENT  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) 8 final}  
 
 
 
TABLE OF CONTENTS 

INTRODUCTION ............................................................................................................... 6 

1 

THE PROBLEM AND THE POLICY CONTEXT OF EU INTERVENTION ......... 7 

1.1  Cancer is the first cause of work-related deaths in the EU ................................ 7 
1.2  Legal context ..................................................................................................... 8 
1.3  How would the problem evolve ........................................................................ 9 

2  WHY SHOULD THE EU ACT? .............................................................................. 12 

2.1  Does the EU have the right to act? .................................................................. 12 
2.2  Why is EU action needed and what is its added value? .................................. 12 
2.3  Process for setting binding OELs and associated provisions under CMD. ..... 14 

3  WHAT SHOULD BE ACHIEVED? ........................................................................ 17 

3.1  What  are  the  general  policy  objectives?  What  are  the  more  specific 
objectives? ....................................................................................................... 17 
3.2  Are  these  objectives  consistent  with  other  EU  policies  and  with  the  Charter 
for fundamental rights? .................................................................................... 18 
3.2.1  Consistency with the Charter for fundamental rights ........................ 18 
3.2.2  Consistency with the REACH Regulation ........................................ 18 

4  WHAT ARE THE VARIOUS OPTIONS TO ACHIEVE THE OBJECTIVES? ..... 21 

4.1  Complementary measures ............................................................................... 21 
4.1.1  Development of further guidance documents .................................... 21 
4.1.2  Biomonitoring .................................................................................... 22 
4.2  Withheld actions .............................................................................................. 22 
4.2.1.  Amending  CMD  in  relation  to  Beryllium  and  inorganic  beryllium 
compounds ......................................................................................... 23 
4.2.2. Amending CMD in relation to Hexachlorobenzene (HCB) .................. 23 
4.2.3. Amending CMD in relation to diesel engine exhaust (DEE) ................ 24 
4.2.4. Amending CMD in relation to rubber process dust and fumes (RPDF) 25 
4.2.5.  Amending  CMD  in  relation  to  4,4'-Methylene-bis-(2  chloraniline) 
(MOCA) ............................................................................................ 26 
4.3  Discarded options ............................................................................................ 26 
4.4  Options and carcinogens retained for consideration ....................................... 27 

5  WHAT  ARE  THE  IMPACTS  OF  THE  DIFFERENT  POLICY  OPTIONS  AND 
HOW DO THEY COMPARE? ................................................................................. 29 

5.1  Study methodology .......................................................................................... 29 
5.1.1. Analytical challenges ............................................................................. 30 
5.1.2. General remarks ..................................................................................... 31 
5.2  Epichlorohydrine (ECH) ................................................................................. 32 
5.3  Ethylene dibromide (EDB) .............................................................................. 35 
5.4  Ethylene dichloride (EDC) .............................................................................. 38 

2 

 
 
 
 
5.5  4,4'-Methylenedianiline (MDA) ...................................................................... 42 
5.6  Trichloroethylene (TCE) ................................................................................. 45 
(PAH)  mixtures  with 
aromatic  hydrocarbon 
5.7  Complex  polycyclic 
benzo[a]pyrene as an indicator ........................................................................ 50 
5.8  Mineral Oils as Used Engine Oils ................................................................... 54 
5.9  Summary of the retained options ..................................................................... 57 

6  OVERALL IMPACT OF THE PACKAGE OF RETAINED OPTIONS ................ 59 

6.1 
6.2 

Impact on workers ........................................................................................... 59 
Impact on businesses ....................................................................................... 60 
6.2.1 
Impact on SMEs ................................................................................ 60 
Impact on competition and competitiveness ..................................... 61 
6.2.2 
Impact on Member States/national authorities ................................................ 61 
6.3 
6.4 
Impact on fundamental rights .......................................................................... 62 
6.5  Subsidiarity and proportionality ...................................................................... 62 
6.6  Budgetary implications .................................................................................... 63 

7  HOW WOULD ACTUAL IMPACTS BE MONITORED AND EVALUATED? .. 63 

7.1  Monitoring arrangements ................................................................................ 63 
7.2  Evaluation arrangements ................................................................................. 64 

8  ANNEX 1 – PROCEDURAL INFORMATION ...................................................... 65 

8.3.1 

8.1  Lead DG .......................................................................................................... 65 
8.2  Consultation of the Regulatory Scrutiny Board (RSB) ................................... 65 
8.3  Evidence used in the impact assessment ......................................................... 66 
IARC Monographs ............................................................................ 66 
8.4  External expertise ............................................................................................ 67 
8.4.1  Use of scientific expertise / Commission expert groups / SCOEL ... 67 
Studies performed by external consultants ........................................ 67 
8.4.2 
Study on chemical agents toxic to reproduction ................................ 68 
8.4.3 

9  ANNEX 2 - STAKEHOLDER CONSULTATION .................................................. 69 

9.2.1 
9.2.2 

9.1  Social partner Consultation ............................................................................. 69 
9.2  Other consultation of stakeholders .................................................................. 71 
25 October 2006 - Workshop of setting OELs for Carcinogens ....... 71 
EU-OSHA  -  Exploratory  survey  of  Occupational  Exposure  Limits 
(OELs) for Carcinogens, Mutagens and Reprotoxic chemical agents 
(CMRs) at EU Member States level (published in September 2009) 71 
9.2.3  Consultation  of  the  tripartite  Working  Party  'Chemicals  at  the 
Workplace' (WPCs) of the ACSH ..................................................... 72 
September 2012 - Workshop in Berlin .............................................. 73 
9.2.4 
9.2.5  Consultation  of  the  members  of  the  ACSH  on  existing  national 
OELs for chemical agents subject to the amendments ...................... 73 
9.2.6  Meetings with Industry and Workers representatives ....................... 73 

10  ANNEX 3 – WHO IS AFFECTED BY THE INITIATIVE AND HOW? ............... 75 

11  ANNEX 4 – OVERVIEW OF THE SEVEN CARCINOGENS .............................. 77 

3 

 
11.1  Sectors, types of cancer caused and estimated number of workers exposed ... 77 
11.2  Legal and policy considerations specific for the proposal - Risk management 
measures under CMD ...................................................................................... 81 
11.2.1  Annex I to the CMD – Process-Generated Substances (PGS) .......... 81 
11.2.2  Annex III to the CMD – OEL ............................................................ 81 

12  ANNEX  5  –  ANALYTICAL  MODEL  USED  IN  PREPARING  THE  IMPACT 
ASSESSMENT ......................................................................................................... 83 

12.1  Exposure estimation ........................................................................................ 83 
12.2  Health  impact  –  methodology  for  estimation  of  the  current  cancer  burden 
(baseline) as compared with the policy intervention scenarios ....................... 84 
12.3  Compliance costs ............................................................................................. 92 
12.4  Analytical assumptions and challenges ........................................................... 92 

13  ANNEX 6 – CARCINOGENICITY OF THE CHEMICAL AGENTS .................... 94 

14  ANNEX  7  -  EXPOSURE  LIMIT  VALUES  IN  EU  MEMBER  STATES  AND 
SOME NON-EU COUNTRIES ................................................................................ 95 

14.1  Annex 7 Table 1. OELs in EU MS .................................................................. 95 
14.2  Annex 7 Table 2. OELs in EU MS – compared to levels recommended by the 
ACSH (option 2) .............................................................................................. 97 
14.3  Annex 7 Table 3. OELs in some non-EU countries ........................................ 98 
14.4  Annex  7  Table  4.  Exposures  in  Member  States  which  have  no  OEL  or  an 
OEL higher that the retained option ................................................................ 99 

15  ANNEX 8 - RELEVANT EU LEGISLATION ........................................................ 99 

15.1  Existing EU-OSH framework .......................................................................... 99 
15.1.1  Directive 89/391/EEC ....................................................................... 99 
15.1.2  Directive 98/24/EC .......................................................................... 100 
15.1.3  Directive 2004/37/EC ...................................................................... 100 
15.1.4  Directive 2009/148/EC .................................................................... 101 
15.2  Internal Market legislation ............................................................................ 101 
15.2.1  REACH Regulation ......................................................................... 101 
15.2.2  CLP Regulation ............................................................................... 102 
15.2.3  Comparison  of  high  level  CMD  and  REACH  provisions  in  relation 
to occupational carcinogens ............................................................ 102 

16  ANNEX  9  –  GENERAL  INFORMATION  ABOUT  THE  CLASSIFICATION 
SYSTEMS REFERRED TO IN THE DOCUMENT .............................................. 104 

16.1  Carcinogens ................................................................................................... 104 
16.1.1  Classification according to the CLP Regulation ............................. 104 
16.1.2  Classification according to IARC .................................................... 105 

17  ANNEX 10 – ADDITIONAL GRAPHICAL MATERIAL .................................... 106 

17.1  Epichlorohydrine ........................................................................................... 106 
17.2  Ethylene dibromide ....................................................................................... 107 
17.3  Ethylene dichloride ........................................................................................ 108 
17.4  4,4,'Methylenedianiline ................................................................................. 109 

4 

 
17.5  Trichlorothylene ............................................................................................ 110 
17.6  Complex PAH mixtures with benzo[a]pyrene as an indicator ...................... 111 
17.7  Mineral Oils as Used Engine Oils ................................................................. 112 

18  ANNEX 11 – ABBREVIATIONS USED .............................................................. 112 

5 

 
INTRODUCTION 

Exposure  to  some  chemical  agents  in  the  workplace  can  cause  cancer.  To  ensure  workers' 
protection against such risks, in 1990 the EU (then EEC) adopted the Carcinogens Directive1) as 
one  of  the  first  individual  directives  under  the  1989  occupational  safety  and  health  (OSH) 
'Framework  Directive'.2  Over  the  following  decade  the  CMD  was  updated  and  extended  to 
become the Carcinogens and Mutagens Directive, which was consolidated in 2004.3 

CMD obligations require employers to eliminate or otherwise minimise exposure of workers to 
cancer-causing  ('carcinogenic')  chemicals  and  elaborates  the  general  requirement  in  the 
Framework  Directive  to  eliminate  all  risks  to  workers.  CMD  establishes  certain  measures 
specific  to  given  chemical  carcinogens,  including 
'process-generated' 
carcinogens  (Annex  I  to  the  CMD),  and  limit  values  over  which  exposure  of  workers  is  not 
allowed (Annex III). 

identification  of 

Scientific  knowledge  about  cancer  and  carcinogenic  chemicals  develops.  At  the  same  time 
technological progress brings new methods of measuring and controlling exposures. In order to 
ensure optimal protection of workers through the risk management measures established in the 
CMD, the Directive needs to keep abreast with the scientific and technological developments by 
updating  the  three  Annexes.  The  Directive  requires  specifically  that  occupational  limit  values 
must be set out in respect of all those carcinogens or mutagens for which this is possible in the 
light of the available information, including scientific and technical data. 

The  Commission  has  initiated  a  scientific  and  economic  assessment  of  25  priority  chemical 
agents with a view to making appropriate updates to the CMD. Around 20 million EU workers 
are  exposed  to  at  least  one  of  these  carcinogens.  For  13  of  those  25  the  evidence  base  and 
analysis  were adequately advanced by 13 May  2016 for the European Commission  to  adopt a 
legislative proposal to amend the CMD4, accompanied by a full impact assessment.5 

For a further seven out of those 25 carcinogens policy options are analysed in this Staff Working 
Document. In the case of the five remaining substances, action through amendment of the CMD  
requires further consideration before proceeding and has been withheld at this stage. 

The aim of the further proposal under consideration remains to reduce exposure to these priority 
carcinogens with a consequential reduction in potential new cases of occupational cancer in the 
affected  workers  in  the  forthcoming  50  years.  The  proposal  will  increase  protection  and  legal 
certainty for at least four million workers, reducing suffering, and improving the length, quality, 
and productivity of the working lives of European workers. It is a part of a longer-term process 
of updating and reviewing the CMD to ensure optimal protection from carcinogenic chemicals 
at work, with further proposals anticipated in the medium term. 

Given the level of scientific and technical knowledge required to identify measures, which at the 
same time  adequately  protect workers and are practically feasible for industries, the European 

1  Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to 
carcinogens at work (Sixth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) 
2  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. 0001 – 0008) 

3  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 (sixth individual Directive within 
the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50) 

4  COM(2016) 248 final of 13 May 2016, 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 

5  Commission  Staff  Working  Document,  Impact  Assessment,  accompanying  the  proposal  for  a  Directive  of  the 
European  Parliament  and  the  Council  amending  Directive  2004/37/EC  on  the  protection  of  workers  from  the 
risks related to carcinogens or mutagens at work (SWD(2016)152/2) 

6 

 
                                                 
Commission  bases  proposals  in  this  area  on  opinions  developed  by  the  tripartite  Advisory 
Committee  on  Safety  and  Health  at  Work  (ACSH).  The  opinions  of  ACSH  take  into  account 
advice  developed  by  the  Scientific  Committee  on  Occupational  Exposure  Limits  (SCOEL)  as 
well  as  other  sources  of  relevant  scientific  data.  The  purpose  of  this  Impact  Assessment  is  to 
verify,  on  the  basis  of  available  socioeconomic  data,  the  robustness  of  ACSH  opinions  and, 
eventually to consider some complementary measures which could be proposed based on further 
scientific information. 

Representatives  of  Member  States  authorities,  employers'  and  workers'  representative  bodies 
within  the  framework  of  the  tri-partite  ACSH  strongly  anticipate  a  second  Commission 
proposal. In its Resolution of 25 November 2015 on the EU Strategic Framework on Health and 
Safety  at  Work  2014-2020,  the  European  Parliament  'firmly  reiterates  its  call  on  the 
Commission  to  present  a  proposal  for  a  revision  of  Directive  2004/37/EC  on  the  basis  of 
scientific evidence adding more binding occupational exposure limit values where necessary'.6 

While  this  Staff  Working  Document  sets  out  the  case  for  further  action,  the  supplementary 
analysis presented here should be read in conjunction with the earlier impact assessment (IA), 
which provided an exhaustive consideration of the CMD and the policy and legal context of the 
proposals. 

The  most  essential  points  are  carried  over  and  supplemented  by  additional  information  and 
analysis regarding these seven additional carcinogens. References to the full impact assessment 
document are given as appropriate. 

1  THE PROBLEM AND THE POLICY CONTEXT OF EU INTERVENTION 

1.1  Cancer is the first cause of work-related deaths in the EU 

53%  of  annual  occupational  deaths  are  attributed  to  cancer,  compared  to  28%  for  circulatory 
diseases  and  6%  for  respiratory  diseases7.  Different  forms  of  cancer  may  be  initiated  or 
promoted by the exposure to carcinogenic and/or mutagenic chemical agents at work. According 
to  a  2016  report  by  the  Netherlands  National  Institute  for  Public  Health  and  the  Environment 
(RIVM)8  91,500-150,500  people  were  newly  diagnosed  with  cancer  in  2012,  caused  by  past 
exposure to carcinogenic substances at work. 57,700 – 106,500 people died in 2012 as a result 
of  a  work-related  cancer.  That  means  that  every  hour  in  EU28,  7-12  people  die  of  cancer 
because of past exposure to carcinogenic substances at work. 

The  below  problem  tree  summarises  the  main  drivers  behind  this  problem  and  the  resulting 
consequences. A detailed description of those is provided in the previous IA. 

6  http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+TA+P8-TA-2015-

0411+0+DOC+PDF+V0//EN 

7  Data concerning the numbers of deaths and diseases attributed to occupational cancer are presented in section 1, 

page 8 of previous IA (SWD(2016)152/2). 

8  Work-related  cancer 

in 

the  European  Union 

:  Size, 

impact  and  options  for  further  prevention, 

http://rivm.nl/en/Documents_and_publications/Scientific/Reports/2016/mei/Work_related_cancer_in_the_Europ
ean_Union_Size_impact_and_options_for_further_prevention, p. 11 

7 

 
 
 
 
 
                                                 
Figure 1. Problem tree 

The carcinogens subject to this assessment have a direct impact on developing different types of 
cancer  and  are  relevant  to  the  sectors  with  high  rates  of  cancer  registrations.  Their  key 
characteristics are presented in a table in Annex 4. In total 12 million EU workers are exposed to 
at  least  one  of  the  seven  carcinogens  (see  Table  1  in  Annex  4).  Complex  PAH  mixtures  with 
benzo[a]pyrene  as  an  indicator,  4,4'-methylenedianiline,  or  oils  that  have  been  used  before  in 
internal  combustion  engines  to  lubricate  and  cool  the  moving  parts  within  the  engine 
(hereinafter, "mineral oils as used engine oils"), are among the top 10 carcinogenic substances to 
which the largest numbers of workers are currently exposed. 

1.2  Legal context 

Under CMD, employers must identify and assess risks to workers associated with exposure to 
specific carcinogens (and mutagens), and must prevent exposure where risks occur. Substitution 
to  a  non-  or  less-hazardous  process  or  chemical  agent  is  required  where  this  is  technically 
possible. Where carcinogens cannot be substituted they must, so far as is technically possible, be 
manufactured  and  used  in  a  closed  system  to  prevent  exposure.  Where  this  is  not  technically 
possible either, worker exposure must otherwise be reduced to as low a level as is technically 
possible.  This  is the so-called  minimisation obligation under  Article 5 of the CMD. This  is a 
more  strict  standard  than  for  other  hazardous  chemicals,  where  the  duty  to  control  risks  is 
always qualified by an assessment of risk by the employer. 

Those  general  provisions  of  the  directive  remain  relevant.  However,  in  the  light  of  available 
scientific data concerning the covered carcinogenic chemicals, there are grounds for considering 
the update of Annexes of the CMD, which provide further clarification of employers' obligations 
with regard to protecting workers from carcinogenic chemicals: 

Annex I clarifies the scope of the directive. 

Annex  I  of  CMD  includes  a  list  of  identified  'process  generated  substances'  (PGS).  These  are 
hazardous  'chemical  agents'  such  as  dust,  fumes,  and  gases  which  may,  for  example,  be 
generated as by-products during production processes, etc. The aim of this list is to clarify for 
workers, employers, and enforcers whether a given chemical agent, if it has not otherwise been 

8 

 
 
 
classified  according  to  the  Regulation  (EC)  No  1272/20089  (CLP),  is  in  scope  of  the  CMD 
controls. 

Annex III establishes 'binding occupational exposure limit values' (OELs) 

For some some chemical agents which fall under the scope of the Directive CMD provides that, 
in  any  case,  exposure  of  workers  must  be  kept  below  'binding  occupational  exposure  limit 
values'  (OELs)  as  established  in  Annex  III  of  the  directive.  An  OEL  addresses  the  inhalation 
route  of  exposure,  describing  a  maximum  airborne  concentration  level  for  a  given  chemical 
agent  above  which  workers  should  not  be  exposed,  on  average,  during  a  defined  time  period. 
OELs can further be annotated with appropriate indications of additional body burden resulting 
from  non-inhalation  routes  such  as,  for  example,  a  'skin'  notation  where  the  dermal  route  of 
exposure is scientifically considered to be relevant. 

Under the CMD, OELs should be established for all those carcinogens and mutagens for which 
the available information make this possible10 and must also be revised whenever this becomes 
necessary in the light of more recent scientific data. 

As explained above, employers must prevent or minimise exposure to occupational carcinogens 
where risks occur. The principle of minimisation of the exposure is stated in article 5.3 of the 
CMD: 'the employer shall ensure that the level  of exposure of workers is  reduced to as  low a 
level as is technically possible'. CMD OELs do not directly affect in theory the legal standard of 
control, which is in any case for minimised exposure. In practice, however, the existence of an 
OEL  provides  a  clear  benchmark  that  enables  professionals  to  'operationalise'  the  concept  of 
minimised exposure, thereby allowing them to easily determine the level to which the exposure 
should at least be reduced. 

Further information about the Annexes of the CMD and their role is in Annex 8 of this report. 

When  analysing  options  for  amendments  of  CMD  Annexes,  the  interface  with  the  REACH 
Regulation  needs  to  be  taken  into  account  as  both  CMD  and  the  REACH  Regulation  are 
relevant for worker protection from carcinogens11. 

Section 3.2.2 provides further information on the interface between REACH and CMD. 

1.3  How would the problem evolve 

Work-related cancer has a strong impact for workers and their families, for Member States and 
for the economy at large. The previous IA describes these impacts in more detail12. Estimations 
on  the  numbers  of  deaths  and  health  costs  between  2010  and  2069  in  case  no  action  is  taken 
regarding these carcinogens are, where available, summarised in the Table 1 below13. Exposure 
to, for example, mineral oils as used engine oils, which potentially concern 1 million workers in 
Europe,  is expected to  cause 130,000 cases  of cancers and 1200 deaths, with  estimated  health 
costs between € 445  m  – and 2,815  m.  These  projections are  made  under the assumption that 

9  Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on 
classification,  labelling  and  packaging  of  substances  and  mixtures,  amending  and  repealing  Directives 
65/548/EEC and Directive 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1)) 

10  Recital 12 of Directive 2004/37/EC. 
11  A  detailed  analysis  of  the  interface  between  REACH  and  CMD  can  be  found  in  section  2.3,  page  29,  of 

SWD(2016)152/2. 

12  See section 1.2 of SWD(2016)152/2. 
13  The  reference  period  of  2010-2069  is  established  in  the  IOM  study  and  used  throughout  the  report.  No 
methodologically  consistent  information  is  available  to  modify  this  reference  period  to  take  into  account 
potential development between 2010 and 2015.  

9 

 
 
                                                 
employers  already  comply  with  the  CMD  obligation  to  eliminate  or  minimise  exposures  to 
carcinogenic  chemicals  and  that  more  detailed  or  more  protective  measures  have  been 
established by some Member States to complement the minimum requirements set at EU level14. 

The  general  obligations  set  by  CMD,  employers'  actions  and  measures  adopted  by  Member 
States contribute overall to lowering exposures. As will be shown in section 5, exposure levels 
have  generally  been  decreasing  in  the  past  years  and  this  positive  trend  could  continue  in  the 
future.  Future forecasts in this area are however far from certain due to scarcity of relevant data 
and the fact that market forces such as raw material and energy prices, developing technology, 
as  well  as  regulatory  changes  can  drive  decreases  or  increases  in  use  which  are  not  easy  to 
predict.  Even  if  trends  were  overall  positive,  under  current  circumstances,  the  existing 
employers practices as well as protective measures at Member State level, do not always reflect 
available  scientific  and  technological  knowledge.15  While  the  Commission  does  not  receive 
information from Member States as for their intentions for developing their national legislation, 
national administrations are aware of the preparatory work at EU level and therefore it is likely 
they will await its results in order not to duplicate efforts.   

Table 1. Estimated current exposures and cancer deaths, cancer cases and related health costs in case no action is 
taken (baseline scenario), 2010-2069 

Carcinogen 

Classification 

including CAS 
numbers where 
relevant 

CLP 

IARC20 

No. of 
exposed 
workers16 

Expected 
no. of 
deaths 

2010 – 
206917 

Expected 
no. of 
cancer 
cases  

2010 – 
206918 

Estimated health 
costs 
2010 – 206919 

1B 

2A 

39,372 

2,400 

2,600 

€ 1,362 m – 2,752 m 

1B 

2A 

< 7,691 

- 

- 

- 

Epichlorohydrine 
106-89-8 

(1-Chloro-2,3-
epoxypropane) 
Ethylene dibromide 
(EDB) 
106-93-4 

(1,2-
Dibromoethane) 

14  See section 2.3 of this document and Annex 7. 
15  http://www.baua.de/de/Publikationen/Fachbeitraege/F1913-2.pdf?__blob=publicationFile&v=6 

http://oiraproject.eu/ 

  http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2015)53&doclanguage=

en 

16  Estimates 
17   A "-" in the table indicated that there was inadequate epidemiological evidence to sustain assessment according 

to the IOM study there.  

18   As above. 
19   As above.  
20  International Agency for Research on Cancer 

10 

 
 
                                                 
Ethylene dichloride 
(EDC) 
107-06-2 

(1,2-
Dichloroethane) 
4,4'-
Methylenedianiline 
(MDA) 

101-77-9 

Trichloroethylene 
(TCE) 
79-01-6 
4,4'-Methylene-bis-
(2-chloroaniline) 
(MOCA) 

101-14-4 

Complex PAH 
mixtures with 
benzo[a]pyrene as 
an indicator 
50-32-8 (for 
benzo[a]pyrene) 
Mineral Oils as 
Used Engine Oils 
(UEOs)21 
Beryllium and 
inorganic beryllium 
compounds 

7440-41-7 (for 
beryllium) 
Hexachlorobenzene 
(HCB) 
118-74-1 
Diesel engine 
exhaust26 

1B 

2B 

< 3,000 

- 

1B 

2B 

3,942,581 

- 

- 

- 

- 

- 

1B 

1 

74,076 

3,300 

4,800 

€ 1,582 m – 5,657 m 

1B 

1  

2,500 

100 

280 

€ 45 m - 353 m 

1B 

1 

7,505,211 

10,000 

13,000 

€ 6.2 b – 194 b 

n/a 

122 

1,050,127 

1,200 

130,000 

€ 445 m – 2,815 m 

1B23 

124 

64,73425 

390 

390 

€ 203 mln - 529 mln 

1B 

2B 

Insufficient 
data 

Insufficient 
data 

Insufficient 
data 

Insufficient data 

n/a 

127 

3,670,792 

230,000 

270,000 

€ 99,084 mln – 
258,000 mln 

21  SCOEL Opinion 2016/405, adopted on 09 June 2016. 
22  for Mineral oils, untreated or mildly treated. 
23  Beryllium and beryllium compounds with the exception of aluminium beryllium silicates. 
24  For beryllium & compounds. 
25  In  the  substance  evaluation  report  according  to  Article  48  of  the  REACH  Regulation,  dated  19  March  2014, 
performed by the German Competent Authorities, a similar assumption about the number of workers exposed is 
made.  However,  the  actual  number  of  workers  exceeding  the  DNEL  derived  by  the  DE  CAs  'could  not  be 
identified based on available data'. 

26 Without differentiation between 'old' and 'new' types of engines – see discussion under point 4.2.3.  
27  For Engine exhaust, diesel. 

11 

 
                                                 
 
 
Rubber process dust 
and fume 
(RPDF) 

n/a 

128 

366,501 

2,990 

4,310 

€ 721 mln - 859 mln 

2  WHY SHOULD THE EU ACT? 

2.1  Does the EU have the right to act? 

Article 153 of the Treaty on the Functioning of the EU (TFEU) empowers the EU to support and 
complement the activities of the Member States as regards the protection of workers' health and 
safety. On this basis the CMD provides a specific basis for action. 

2.2  Why is EU action needed and what is its added value? 

Amending the CMD can only be done by action at EU level and it presents an EU added value 
in several respects. 

Updated scientific basis of prevention and protection 

Scientific  knowledge  about  carcinogenic chemicals is  constantly developing  and technological 
progress enables improvements in protection of workers. In order to ensure that the mechanisms 
for protecting workers from carcinogenic chemicals established in the CMD are as effective as 
possible, the directive needs to be kept more up to date with those developments. 

Available  scientific  evidence  points  to  the  need  to  establish  new  OELs  in  Annex  III  for  a 
number  of  substances  for  inhalation  exposures  including  for  information  on  other  routes  of 
exposure  (e.g.  dermal)  which  could  contribute  significantly  to  the  overall  body  burden  of  the 
workers29.  In  addition,  there  is  scientific  information  which  could  serve  as  a  background  to 
including mineral oils as used engine oils in Annex I of the CMD. 

Updating CMD to take account of newer scientific evidence is an effective way to ensure that 
preventive measures would be adjusted accordingly in all Member States.  

Improved clarity and enforcement 

Including  substances  in  Annex  I  could  contribute  to  the  clarity  for  employers,  workers  and 
enforcement  authorities  as  for  what  falls  under  the  scope  of  the  Directive,  provided  that  the 
definitions make it possible to specifically identify the substance. 

Establishing new OELs in Annex III could provide a common reference point that can be used 
as  a practical tool  by employers, workers and enforcers to assess compliance with the general 
CMD  requirements.  OELs  can  also  be  used  by  process  plant  and  machinery  designers  when 
planning  new,  or  considering  alterations,  to  existing  process  plant.  Clear  support  for  their 
continued use has been expressed from key stakeholders30. 

Ensuring the same minimum level of protection across the EU 

In case of all carcinogenic chemical agents where OELs are proposed in this initiative at least 
half  of  the    Member  States  have  not  yet  established  legally  enforceable  OELs  or  have  less 
protective  ones.  For example, 17 Member States  have  set  no limits or  less  protective ones  for 
trichloroethylene – the same is true for 20 Member States in the case of EDB and 23 in the case 
of MDA. Also approaches to and definitions of the considered PGS differ significantly. 

28  For Rubber manufacturing industry. 
29  References to relevant SCOEL conclusions are provided in substance-specific subsections in the Section 5. 
30  See section 2.2, page 27, of SWD(2016)152/2. 

12 

 
 
 
                                                 
Lack of EU action will most likely mean that there will remain Member States where no limit 
values  exist  for  certain  carcinogens  or  where  those  values  are  too  high  to  ensure  adequate 
worker protection. A minimum standard across the EU will not be ensured, to the detriment of 
worker protection. 

Contribution to level-playing field 

Additionally,  while  setting  more  stringent  OELs  at  national level  is  in  line  with  the minimum 
standard  nature  of  the  CMD,  national  OELs  vary  considerably  in  some  cases  –  leading  to 
significantly different levels of protection. For trichloroethylene, for example, the values range 
from 0.6 to 100 ppm (3.3 to 550 mg/m3).31  

This can also have negative consequences for the internal market because businesses operating 
in Member States with less stringent levels or no exposure limit value at all would benefit from 
an  undue  competitive  advantage.  It  may  provide  a  potential  incentive  for  companies  to  locate 
their  production  facilities  in  Member  States  with  the  lower  standards.  For  example,  for 
trichloroethylene producers and professional users in countries such as UK, Cyprus or France, it 
is sufficient to comply with exposure limits 10 times higher (i.e. less constraining) than in some 
other countries such as Belgium, Denmark, Spain or Finland among others..32 

Establishing common definitions in Annex I to the Directive and setting EU OELs in Annex III 
will  not  completely  eliminate  the  differences  between  Member  States,  as  they  retain  the 
possibility to adopt more protective measures. However, it will provide certainty that there is a 
core definition and/or  enforceable  exposure limit for all concerned  carcinogens in all  Member 
States. As illustrated in the graphs in Annex 10 it will also significantly minimise the scope for 
variation  in  OELs  across  the  EU.  The  examples  of  the  currently  existing  EU  OELs  (e.g.  for 
hardwood dust, included in the 1st Commission proposal for amendment of the CMD) show that 
a majority of Member States in practice adopt the EU OEL directly. 

Assuming burdens at EU level related to derivation of limit values 

The process of establishing limit values is very complex and requires a high level of scientific 
expertise. An important advantage of setting OELs at EU level is that it eliminates the need for 
Member States to conduct their own scientific analysis.  

Since the establishment of SCOEL the onus for developing OELs for hazardous chemical agents 
in  general,  and  carcinogens  in  particular,  has  shifted  to  the  EU  level  and  the  European 
Commission.  Accordingly this important activity to contribute to the protection of workers is 
now driven principally at EU level, forming important driving context for the present intiative. 

The  annual  budget  for  the  operation  of  SCOEL  in  the  year  2015-2016  is  approximately 
€400,000,  not  including  significant  dedicated  resources  providing  the  administrative  and 
scientific secretariat functions. 

The cost of undertaking the relevant scientific analysis at Member State level would differ as a 
result  of  different  organisational  requirements,  prioritisation  and  resource  allocation  and  other 
administrative  decisions  –  making  an  extrapolation  assuming  the  SCOEL  resources  are 
representative  is  therefore  difficult.    Assuming  that  a  majority  of  Member  States  chose  to 
establish  or  continue  operating  scientific  committees  to  undertake  equivalent  work  for  all 
hazardous  chemical  agents  (not  just  carcinogens  and/or  mutagens)  would  imply  savings  of 
between €6 000 000 and €12 000 000 at Member State level. 

31  A comprehensive overview of the national OELs for each of the chemical agents covered in this report  and a 

summary overview table can be found in Annex 7. 

32  A detailed analysis of the issues related to OELs at MS level is provided in section 1.1.3 of SWD(2016)152/2. 

13 

 
                                                 
Given the limited resources for OSH at national level, this could release funds currently spent on 
managing national scientific committees to be redirected into other OSH priorities. 

2.3  Process for setting binding OELs and associated provisions under CMD. 

A  simplified  outline  of  the  process  for  the  development  of  EU  Occupational  Exposure  Limit 
Values for carcinogens is set out here. 

After  completion  of these steps the Commission  prepares and adopts the legislative procedure 
which then follows the ordinary legislative procedure for adoption and subsequent transposition 
and implementation at Member States level.  

Figure 2. Simple representation of typical EU OEL setting procedure 

Step 1:  Social partners consultation 

TFEU  Article  154  requires  a  formal  two-stage  consultation  of  the  social  partners  at  EU  level 
(management and labour) prior to submitting proposals in the social policy field. As regards the 
present initiative this consultation took place in 2004 and 2007. Annex 2 (section 9.1.) provides 
further information on the outcomes of the consultation.  

Due to complex nature of this initiative, a further exchange of views between the Commission 
services and the social partners took place towards the end of the IA development stage of the 
overall  process,  once  the  policy  options  had  been  clarified.  This  ensured  the  continued  active 
involvement of the social partners. 

Step 2:  Priority  setting 

It is neither realistic nor desirable to set an OEL for every hazardous chemical that may be used 
at the workplace.  Instead it is appropriate to identify and target priority substances. 

14 

 
 
 
 
 
The  selection  of  the  original  25  carcinogens  considered  in  this  and  previous  related  Impact 
Assessment was based on a consultative approach including stakeholder engagement at member 
states  and  social  partner  levels,  and  taking  into  account  general  considerations  such  as  the 
following: 

 

the potential to cause adverse health effects resulting from occupational exposure. 

  Processes resulting in exposure or combined exposures to chemicals with the potential to 
cause  adverse  health  effects  resulting  from  a  work  activity  for  which  markers  of 
exposure are needed. 

  Emerging specific issues on a basis of reported evidence and expert judgment. 

  Degree of evidence for adverse effects.  

  Characteristics of the adverse effects (severity, potency, reversibility, specificity). 

  Estimated number of workers exposed. 

 

Identified exposure patterns that pose difficulties for the control of exposures. 

  Policy  considerations,  such  as  problematic  disparities  with  or  between  other  relevant 
threshold  values,  degree  of  stakeholders'  interest  in  having  an  EU  OELV,  or  other 
institutional priorities. 

The Commission is committed to continuing efforts to strengthen application of such criteria in 
the future.  

Step 3:  Scientific evaluation and public consultation 

Article  16  of  the  CMD  states  that  scientific/technical  data  should  be  included  in  the  basis  on 
which OELs  are  set.   CMD does  not  determine which scientific body should be the source of 
such data – in practice the Commission and the ACSH principally seek the advice of SCOEL, 
but can also refer to scientific information sourced elsewhere as long as the data is adequately 
robust  and  is  in  the  public  domain  (e.g.  IARC  monographs  or  conclusions  of  national  OEL-
setting science committees).33 

SCOEL  is  an  independent  scientific  committee,  established  by  a  Commission  Decision  and 
composed of 21 experts appointed in their personal capacity as leading experts in fields relevant 
for  protection  of  workers  from  risks  associated  with  workplace  exposure  to  hazardous 
chemicals.34 

SCOEL carries out scientific evaluation at EU level and as a result publish a single evaluation 
document  (previously  a  'SCOEL  SUM',  more  recently  a  Recommendation  or  Opinion)  for 
hazardous chemicals where there is priority concern for worker protection.  The procedures for 
the adoption of a Recommendation by SCOEL include an external public consultation including 
directly  informing  a  list  of  identified  contact  points  in  all  of  the  Member  States;  this  ensures 
scrutiny  of  the  scientific  evidence  and  methodological  approach  used  by  SCOEL  and  ensures 
transparency of the process. 

SCOEL has concluded opinions or recommendations on all the carcinogens analysed in chapter 
5 – further details are provided in Annex 6. 

33 See “Figure 3. Simple representation of EU OEL setting procedure” (annex 9).  
34  As  established  by  Commission  Decision  2014/113/EU  on  setting  up  a  Scientific  Committee  on  Occupational 

Exposure Limits for Chemical Agents and repealing Decision 95/320/EC, OJ L 62, 4.3.2014, p. 18 

15 

 
 
                                                 
Step 4:  Tripartite consultation of Member States and social partners 

While the aim of ensuring the protection of the health of workers is maintained, binding OELs 
set  under  CMD  must  also  reflect  other  factors  such  as  'feasibility'  and  take  into  account  the 
views of the social partners. For this reason the Opinion of the ACSH is requested. 

The  ACSH  is  a  tripartite  body  set  up  in  2003  by  a  Council  Decision  (2003/C  218/01)  to 
streamline the consultation process in the field of occupational safety and health and rationalise 
the bodies created in this area by previous Council Decisions.  The ACSH remit is to assist the 
Commission  in  the  preparation,  implementation  and  evaluation  of  activities  in  the  fields  of 
safety  and  health  at  work.  The  ACSH  is  composed  of  three  full  members  per  Member  State, 
representing national governments, trade unions and employers' organisations, also organised in 
three separate interest groups within the Committee. 

The ACSH is supported by working parties of experts on given topics of interest according to 
mandates agreed by the plenary Committee.  These working parties are also tripartite but usually 
with smaller selected expert membership. 

The  ACSH  Working  Party  on  Chemicals  (WPC)  undertakes  broader  chemicals  policy  support 
for the ACSH and Commission and in particular detailed technical and policy negotiation of EU 
limit  values.    This  process  is  informed  by  all  available  evidence  regarding  appropriate  and 
achievable limit values including adopted SCOEL Recommendations and any national OELs  

It is during these, often complex, discussions that the level of ambition which is appropriate for 
a  specific  EU  OEL  for  a  carcinogen  is  established,  taking  into  account  the  views  of 
representatives from the government, workers, and employers interest groups. 

The  ACSH  discusses  adopted  SCOEL  Recommendations  (and/or  other  appropriate  scientific 
evidence) and adopts a formal Opinion. 

In  practice  an  OEL  emerging  from  this  process  reflects  a  deep  technical,  socioeconomic,  and 
political consideration of what is achievable by employers across the EU and also ensures that 
workers'  health  is  adequately  protected.    These  Opinions  are  also  adopted  taking  into  account 
that  OELs 
the  CMD 
elimination/minimisation  obligation,  which  establishes  an  appropriate  and  exceptionally  high 
legal standard for workplace- and process-specific risk control. 

exist  within 

the  broader 

context  of 

carcinogens 

for 

Between 2009 and 2011 an external contractor evaluated, on behalf of the Commission, health, 
socio-economic  and  environmental  aspects  of  the  proposed  amendments  to  CMD  in  order  to 
inform impact assessment according to the regulatory procedures in place at that time. Between 
2010 and 2013 the Working Party on Chemicals of the ACSH undertook detailed discussion on 
these  issues  in  an  increased  work  schedule,  aiming  to  secure  stakeholder  engagement  and 
agreement on values to propose for ACSH adoption. 

Step 5:  Impact assessment 

The  impact  assessment  takes  all  of  the  above  steps  into  consideration  and  the  IA  Report  is 
presented  to  the  Commission  services  Regulatory  Scrutiny  Board  in  accordance  with  the 
relevant internal rules for initiatives with foreseeable significant impacts. 

The  options  for  action  proposed  by  the  ACSH  are  established  through  a  thorough  scientific, 
technical and socioeconomic discussion and in general the tripartite agreements reached in the 
Advisory Committee would be put forward in the eventual Commission's proposal. However, in 
line with the Better Regulation guidelines, an IA is conducted before presenting the proposal. In 
the  IA  the  Commission  verifies  the  ACSH  opinions  on  the  basis  of  a  dedicated  study.  Other 
sources  of  information  and  data  are  duly  taken into account  at this  stage.  EU-OSHA  provides 
input based on recent scientific research, concerned Commission services are asked for relevant 

16 

 
 
data collected by the European Chemicals Agency (ECHA) and additional input from industries 
is  requested  with  the  help  of  DG  Internal  Market,  Industry,  Entrepreneurship  and  SMEs. 
Follow-up meetings with social partners are organised.  

As a result of the IA the ACSH-based options could be withheld, retained or complemented. 

A proposed action is  withheld if the ACSH opinion has not been sufficiently consensual, and 
the  Commission's  assessment  leads  to  concerns  about  the  proposal  (e.g.  as  regards  legality  or 
clarity).  This  does  not  mean  that  the  Commission  discards  the  option.  Rather,  important 
additional elements are needed before further assessing the option.   

An option is retained if the ACSH opinion has been clear and consensual, there are no concerns 
about  legality  and  clarity  of  the  option  and  the  socioeconomic  assessment  confirms  the 
robustness of ACSH opinions in terms of effectiveness, efficiency and coherence. 

An  option  may  be  further  complemented  if  the  ACSH  opinion  did  not  take  into  account  an 
important scientific element, such as the need to establish a skin notation. 

Agreement of the RSB is a prerequisite before presenting the draft proposal for adoption by the 
college of Commissioners. 

Ensuring the active engagement of stakeholders during the overall process. 

The process of setting binding OELs under CMD actively engages the MSs and social partners 
during the key stages: 

  Two stages consultation of the social partners' at EU level in accordance with TFEU. 

  External consultation on SCOEL Recommendations before adoption. 

  Development of Opinions of the tri-partite ACSH via its Working Party on Chemicals. 

A  further  advantage  of  an  OEL  is  that  it  sets  an  objective  to  be  achieved  without  being 
prescriptive  in  how  this  should  be  achieved.    Therefore,  it  can  accommodate  technical 
developments in the world of work such as new or enhanced processes and is consistent with the 
policy objective of employers further lowering the level of exposure below the level of the OEL 
when, for specific processes, this can be achieved.  In this context EU-OSHA plays an important 
role in facilitating the exchange on good risk management practices within and between industry 
sectors across the Member States. 

3  WHAT SHOULD BE ACHIEVED? 

3.1  What are the general policy objectives? What are the more specific objectives? 

The  main  general  policy  objective  of  this  initiative  is  to  ensure  and  maintain  a  high  level  of 
protection of worker's health and safety in the European Union. 

The specific objectives are: 

  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 towards a better level 
playing  field  for  economic  operators  by  reducing  divergences  in  national  protection 
levels. 

17 

 
 
 
3.2  Are  these  objectives  consistent  with  other  EU  policies  and  with  the  Charter  for 

fundamental rights? 

Promoting workers’ health is in line with the ambition for a Triple A Social Europe rating set by 
the Juncker Commission. It has a positive impact on productivity and competitiveness.35 

3.2.1  Consistency with the Charter for fundamental rights 

The objectives of the initiative are consistent with article 2 (Right to life) and article 31 (Right 
to fair and just working conditions) of the EU Charter of Fundamental Rights. Ensuring a safe 
and healthy work environment is a strategic goal for the European Commission.36 
3.2.2  Consistency with the REACH Regulation37 

The REACH Regulation, adopted in 2006, is of particular relevance for worker protection from 
risks  associated  with  the  presence  of  hazardous  chemicals  at  the  workplace.REACH 
consolidated  and  evolved  several  parts  of  the  EU  chemical  risk  control  system  –  principally 
those  relating  to  risk  assessment  and  internal  market  risk  management  measures.  REACH 
further augmented these changes by establishing a new 'authorisation' risk management option. 

Both CMD and the REACH Regulation, are relevant for worker protection from the majority of 
carcinogens considered in this assessment.38 

A chemical carcinogen may appear on both CMD Annex III and REACH Annex XIV without 
systematic  conflict.    The  OSH  Framework  Directive  –  under  which  CMD  is  made  –  applies 
without prejudice to existing or future national and EU provisions which are more favourable to 
protection  of  the  safety  and  health  of  workers  at  workʼ.    REACH  in  turn  applies  without 
prejudice to worker protection legislation, including the CMD. 

Clear synergies between REACH and worker protection legislation can be seen  – including in 
particular that REACH 'registration' should result in more information being available to inform 
chemicals risks assessment. REACH 'authorisation' also both establishes, for a given chemical 
agent, a clear and renewed pressure to substitute for safer alternatives, and can drive applicants 
to improve their worker protection risk assessments and controls. At the same time, adoption of 
EU OELs can be useful inputs for REACH risk characterisation. 

The  applicable  provisions  of  REACH  authorisation  and/or  restriction,  where  relevant  of  the 
chemical agents under consideration in this report, are as follows39: 

  Out of scope of REACH: mineral oils as used engine oils, PAHs (where process 

generated), rubber process dust and fumes (collectively), DEE; 

 

Identified as a 'substance of very high concern' (SVHC) and candidate for being made 
subject to authorisation: benzo[a]pyrene 

  Currently subject to authorisation: EDC, MDA, MOCA, TCE; 

35 COM(2010) 2020 and COM(2014) 130 final. 

36  Communication  from  the  Commission  on  the  EU  Strategic  Framework  on  Health  and  Safety  at  Work  2014  – 

2020 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52014DC0332&from=EN.  

37  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning 

the Registration, Evaluation, Authorisation and Restriction of Chemicals 

38  A  detailed  analysis  of  the  interface  between  REACH  and  CMD  can  be  found  in  section  2.3,  page  29,  of 

SWD(2016)152/2. 

39  A more detailed list of REACH status of the concerned chemical agents can be found in Annex 8. 

18 

 
 
                                                 
  Currently subject to restriction: benzo[a]pyrene as a member of the group entry for  eight 

PAHs (Entry 50 of Annex XVII to REACH). 

  Currently not subject to SVHC listing, authorisation, or restriction: Beryllium, EDB, 

ECH, HCB. 

Under  REACH  'authorisation'  certain  chemicals  with  a  specific  hazard  profile  such  as 
carcinogens  (and  others)  may  be  identified  as  SVHCs  and    be  subjected  to  an  authorisation 
requirement. Such substances, which are listed in Annex XIV to REACH, may only be placed 
on the market and/or used if an authorisation has been granted for a specific use. The conditions 
for granting an authorisation are set out in Article 60 of REACH. An authorisation may only be 
granted  for  specific  uses  and  operators  who  have  demonstrated  that  the  risks  (including 
occupational  risks,  which  is  the  main  exposure  scenario  today  for  almost  all  the  substances 
listed in Annex XIV) are either adequately controlled (the 'adequate control route') or are lower 
than the socio-economic benefits derived from the use (the 'socio-economic route') and there are 
no suitable alternatives. In the application for authorisation, and for each of the uses covered in 
the  application,  companies  must  include  an  assessment  of  the  exposure  of  workers  (and  other 
populations,  as  well  as  of  man  via  the  environment,  if  relevant)  to  the  substance(s),  and  the 
related risk, at individual workplaces concerned. If the risk management measures set out in the 
application are not judged (by the ECHA Committee on Risk Assessment) to be appropriate and 
effective,  conditions  and/or  monitoring  arrangements  for  the  control  of  these  risks  can  be 
imposed in the authorisation decision to reduce exposure and risks even further. 

REACH  authorisation  provisions  are  designed  to  dovetail  and  complement  pre-existing  EU 
regulatory approaches. In particular REACH Article 58(2) states that 'Uses or categories of uses 
may be exempted from the authorisation requirement provided that, on the basis of the existing 
specific  Community  legislation  imposing  minimum  requirements  relating  to  the  protection  of 
human health or the environment for the use of the substance, the risk is properly controlled.' 

The meaning of the first set of conditions of this exemption ('on the basis of the existing specific 
Community  legislation  imposing  minimum  requirements  relating  to  the  protection  of  human 
health  or  the  environment  for  the  use  of  the  substance')  is  subject  to  consideration  by  the 
General Court in Case T-360/13 VECCO and Others v COM concerning chromium trioxide (a 
carcinogen mainly of concern for worker inhalation risks for which there is no EU OEL) and the 
legality  of  a  Commission  Regulation  which  included  the  substance  in  Annex  XIV  to  REACH 
without  granting  an  exemption  for  certain  uses  under  Article  58(2).    The  case  is  currently 
subject to appeal. 

Some uses of substances are in any case exempted from the authorisation requirement.  This is 
the case of 'intermediates'.40 

Intermediates as  defined by REACH  are chemical substances which are manufactured for and 
consumed in or used for chemical processing in order to be transformed into another substance. 

Occupational  exposure  to  intermediates  may  nevertheless  occur  for  example  during  cleaning, 
maintenance, etc., where residues may be present and/or where process-streams are interrupted 
and containment may be compromised. 

INTERMEDIATES:  AN EXAMPLE 

40  Apart  from  'non-isolated  intermediates'  which,  during  synthesis,  are  not  intentionally  removed  (except  for 

sampling) from the equipment in which the synthesis takes place. 

19 

 
                                                 
The chemical substance EDC is a carcinogen and as such is subject to CMD.  Options relating to 
setting  an  inhalation  OEL  with  a  skin  notation  for  EDC  are  considered  in  this  IA.    Further 
details relating to EDC are set out in section 5.3. 

EDC  is  also  subject  to  REACH  Authorisation.    Applications  for  authorisation  have  been 
received  for  a  range  of  industrial  uses  of  EDC  as  a  process/extraction/emulsifying  solvent, 
reaction/crystallisation medium, or swelling agent. 

The main uses of EDC (more than 99% of the total volume) are however as an intermediate and 
are therefore outside the scope of authorisation. 

For example EDC is used as an intermediate in the manufacture of the chemical substance vinyl 
chloride  monomer  (VCM,  or  'chloroethylene').    The  chemical  process  used  consists  of 
continuous feeding of EDC to a dehydrochlorination reactor, where it is transformed into VCM, 
which  is  then  distilled  as  an  isolate  from  simultaneously-generated  hydrogen  chloride  (HCl).  
EDC (1,2 dichloroethane) reacts according to the following reaction scheme 

Side reactions may take place during the manufacture that result in the formation of ethylene, 1 
butene, 2 butene and 1,3 butadiene.  These end up in the composition of the manufactured VCM 
(chloroethylene) as impurities. 

This use of EDC would not be subject to REACH authorisation, but workers are protected in EU 
legislation from potential exposure to EDC during this process and any associated work activity 
– for example decommissioning of a used dehydrochlorination reactor – by the provisions of the 
OSH  Framework  Directive,  the  CMD  and  in  particular  the  duty  to  eliminate  or  minimise 
exposures, and would be supported by an EU OEL as considered in this assessment. 

REACH  registration  also  contributes  to  worker  protection  by  ensuring  employers  receive 
effective and timely advice regarding risk management from the supply chain. 

Unintended process-generated substances would also not be in scope of REACH authorisation. 

The  co-existence  of  a  CMD  OEL  alongside  REACH  authorisation  provides  several  important 
benefits for the practice of both OSH and REACH worker protection provisions. 

  CMD  applies  to  all  potential  worker  exposures  –  including  those  associated  with 
intermediates,  and  process-generated  substances,  or  resulting  from  unintended  or 
misuse-related release. 

  For  non-threshold  carcinogens  the  OEL-setting  process  provides  a  relatively  thorough 
and  robust  process  for  establishing  minimum  standard  exposure  levels  –  ultimately 
passing  through  the  co-legislator  for  adoption  –  based  on  a  science  and  stakeholder 
consultation  based  process.  This  process  can  support  Commission  decision-making  in 
implementing the REACH authorisation provisions – in particular whether the exposure 
of workers demonstrated in authorisation applications can be considered acceptable. 

20 

 
 
The overall relationship between the REACH Regulation and OSH Directives (including some 
references  specific  to  the  CMD)  has  been  subject  of  an  opinion  of  the  'REFIT  Platform'41 
adopted on 27-28 June 2016.42  

In  this  document  the  REFIT  Platform  recognises  that  the  two  sets  of  legislation  are  mutually 
reinforcing  but  points  out  that  the  interface  between  REACH  and  OSH  legislation  is  complex 
and that further clarification is needed.  The concerned Commission services share that analysis 
and  are  working  on  providing  clarifications  and  on  ensuring,  in  general,  better  interaction 
between both areas. 

In  particular,  DG  Employment,  Social  Affairs,  Skills  and  Labour  Mobility,  DG  Environment, 
and  DG  Internal  Market,  Industry,  Entrepreneurship  and  SMEs  systematically  share 
participation in technical and policy discussions, hold workshops to further explore how the two 
regulatory  frameworks  could  interact,  formalise  cooperation  between  the  REACH  and  OSH 
agencies to foster exchanges and avoid scientific conflict, and work in order to promote a better 
collaboration between the enforcement Authorities at national level. 

Some examples of increased cooperation regarding the interaction between  OSH  and REACH 
are: 

 

the ECHA and the SCOEL have been mandated to create a Joint Task Force to further 
improve their mutual understanding and work towards agreed approaches. 

  consideration  is  given  to  the  OSH  legislation  during  the  process  of  identifying 
substances as possible candidates for authorisation and restriction under REACH during 
the so-called risk management option analysis process. 

 

the  ECHA  is  working  actively  with  stakeholders  around  safety  data  sheets  in  order  to 
facilitate effective communication in the supply chains. 

 

the Commission plans to hold a workshop on the OSH-REACH interface during 2017. 

It is also worth noting that the links between REACH and OSH will be addressed in the ongoing 
OSH and REACH evaluations, which are expected to be completed in the course of 2017, and 
that  the  concerned  Commission  services  are  currently  working  on  a  Common  Understanding 
Paper considering the interface between REACH and OSH legislation. 

4  WHAT ARE THE VARIOUS OPTIONS TO ACHIEVE THE OBJECTIVES? 

4.1  Complementary measures 

4.1.1  Development of further guidance documents 
During  discussions  in  the  ACSH43  and  the  social  partners  consultation  the  need  for  further 
guidance  was  expressed  on  several  issues  relating  to  the  CMD44.  In  order  to  meet  this  need, 
actions to develop, for example, additional guidance documents on particular questions raised, 
are ongoing or will be undertaken as complementary measures to this initiative. These are not 
alternative  options  to  amending  the  CMD  but  are  rather  part  of  the  baseline  and  will  further 
reinforce potential positive effects of the considered options. 

41 The European Commission established the 'REFIT Platform' of Member State government and EU stakeholder 
representatives to support the simplification of EU law and the reduction of regulatory burden without detracting 
from the policy objectives of EU law. 

42 http://ec.europa.eu/smart-regulation/refit/refit-platform/docs/recommendations/opinion_chemicals.pdf 
43  Opinion of the ACSH of 05/12/12. 
44  See section 4.1, page 32, of SWD(2016)152/2. 

21 

 
 
                                                 
4.1.2  Biomonitoring 

Biomonitoring  or  biological  monitoring  is  a  way  of  assessing  exposure  to  a  certain  hazardous 
chemicals by measuring the chemical or its breakdown products in a biological sample (usually 
urine, blood or breath).  

Biomonitoring  provides  very  useful  information  for  employers,  workers,  health  practitioners, 
and enforcers to help them undertake effective and appropriate health surveillance in particular 
in  cases  where  biomonitoring  is  considered  to  be  an  additional  or  sometimes  the  single  most 
appropriate  tool  to  evaluate  the  exposure  of  workers  to  a  particular  carcinogen  (e.g.  where 
chemicals can be significantly absorbed through the skin)45. 

Over  the  years,  SCOEL  has  recommended  biological  monitoring  values  for  a  number  of 
carcinogenic substances, some of them also part of this initiative. 

During  this  impact  assessment,  the  Commission  explored  possibilities  to  introduce  those 
SCOEL recommendations as part of an entry for a carcinogen in Annex III to the Directive.  

However,  in accordance with  Article 5 (4) CMD, a biological monitoring value established in 
Annex III would be 'binding', in the sense that employers would be under the obligation not to 
exceed that limit value. Such a regulatory approach does not appear legally possible due to the 
absence  in  the  CMD  of  specific  provisions  concerning  biological  monitoring  values.  This 
analysis was confirmed by the Legal Service of the Commission. 

The Commission will consult the ACSH on approaches regarding biological monitoring. 

4.2  Withheld actions 

Commission's analysis led to a conclusion that action in relation to five carcinogens should be at 
this stage withheld. As described in section 2.3. a course of action proposed by the ACSH can 
be withheld from further assessment if the opinion has not been sufficiently consensual, and/or 
if there are concerns about legality or legal clarity of the proposal.  

Table 2. Overview of withheld actions 

Carcinogen 

Outcome of ACSH 
discussion/Commission's 
assessment  

Next steps 

Beryllium and 
inorganic beryllium 
compounds 

Hexachlorobenzene 
(HCB) 

Diesel engine exhaust 
(DEE) 

No ACSH opinion adopted to 
date. 

Will be examined once ACSH 
opinion available. 

ACSH concluded an OEL would 
not be appropriate given the status 
of the substance. 

Substance banned in the EU. 
Use will be monitored to 
ensure that workers safety is 
not compromised. 

ACSH opinion non conclusive – 
further research required. Lack of 
a clear agreed definition of the 
carcinogen – risk of legal 
unclarity and unintended effects. 

Further research and 
consultation required including 
on individual components, 
aiming for specific OELs. 

45  Manno, M., Viau, C., in collaboration with Cocker, J., Colosio, C., Lowry, L., Mutti, A., Nordberg, M. & Wang, 

S., ‘Biomonitoring for occupational health risk assessment (BOHRA)', Toxicology Letters, 2010, pp. 3-16 

22 

 
                                                 
Rubber process dust 
and fumes (RPDF) 

4,4'-Methylene-bis-(2 
chloraniline) (MOCA) 

Mixture complexity makes it 
difficult to establish a sufficiently 
clear definition. Lack of 
agreement on the most 
appropriate approach  between 
workers and employers 
representatives in the ACSH. 

ACSH Opinion advised that the 
establishment of an airborne OEL 
is not useful to protect workers as 
this carcinogen has a high 
potential for dermal absorption. 

Further research and 
consultation required including 
on individual components, 
aiming for specific OELs. 

Further consideration of this 
substance is necessary before 
concluding on the best 
approach which may be a 
biological limit value together 
with a 'skin' notation, and 
possibly to complemented by 
an airborne OEL in order to 
improve consistency with 
REACH. 

Further  reasoning  for  withholding  action  at  this  stage  for  each  of  the  five  carcinogens  is 
provided below. 

4.2.1. Amending CMD in relation to Beryllium and inorganic beryllium compounds  

Exposure to beryllium and its compounds at the workplace occurs mainly via inhalation, which 
can cause lung cancer and may also cause beryllium sensitization and chronic beryllium disease, 
which  is  an  incurable  disease  causing  scarring  of  the  lung  tissue.  Dermal  exposure  may  also 
cause non-carcinogenic ill health effects. 

While  beryllium  is  an  important  chemical  for  which  an  amendment  of  the  CMD  may  be 
considered in the future, at this stage in the absence of ACSH opinion there is insufficient basis 
for such a decision.  

Consequently action on this carcinogen is withheld at this stage and an amendment of CMD in 
relation  to  Beryllium  and  inorganic  beryllium  compounds  will  be  considered  again  once  the 
SCOEL  recommendation  is  finalised,  ACSH  position  agreed  and  relevant  data  on  impacts 
collected. 

4.2.2. Amending CMD in relation to Hexachlorobenzene (HCB) 

HCB is a chlorinated aromatic hydrocarbon. It has been classified by the International Agency 
for  Research  on  Cancer  (IARC)  as  possibly  carcinogenic  to  humans  (Group  2b)  and  as  a 
Category 1B carcinogen in the EU under CLP.  

HCB  is  listed  under  the  UN  Stockholm  Convention  on  Persistent  Organic  Pollutants  (POP) 
which entered into force on 17 May 2004. The Community ratified the Stockholm Convention 
on 16 November 2004. The Convention has been implemented at EU level by Regulation (EC) 
2004/850.46  The  Regulation  bans  production,  placing  on  the  market  and  use  of  the  10 
intentionally  produced  POP  substances  listed  in  the  Stockholm  Convention  (HCB  is  one  of 
them). This Regulation entered into force on 20 May 2004 and is directly applicable in all EU 
Member States. HCB may still be formed as an unintentional by-product during the manufacture 

46  http://eur-lex.europa.eu/legal-content/AUTO/?uri=CELEX:32004R0850&qid=1475065457841&rid=1 

23 

 
 
 
                                                 
of  other  chlorine  containing  compounds  or  as  an  impurity  formed  as  a  result  of  various 
industrial  processes.  Assumptions  that  considerable  exposure  of  workers  to  the  substance  can 
still  occur  in  form  of  a  unintentional  by-product  could  however  not  be  substantiated  based  on 
available data.  

ACSH  in  its  opinion  stated  that  'No  OEL  is  proposed  due  to  the  fact  that  the  substance  has 
already been prohibited globally under the Stockholm Convention and the Protocol on Persistent 
Organic  Pollutants  under  the  UN  Convention  on  Long-Range  Transboundary  Air  Pollution'. 
Given the legal status of the chemical, it is therefore  not considered appropriate to include  the 
substance in this amendment of the CMD. Use of the substance will be monitored to ensure that 
workers' safety is not compromised. 

4.2.3. Amending CMD in relation to diesel engine exhaust (DEE)  

DEE contains a complex mixture of gases, vapours, liquid aerosols and particulate matter which 
are the products of combustion and can be hazardous to health.47 Some of these components are 
known  carcinogens  (e.g.  PAHs,  formaldehyde,  1,3-butadien,  or  benzene),  others  are  not  (e.g. 
carbon  monoxide,  carbon  dioxide,  or  oxides  of  nitrogen).  For  some  of  the  non-carcinogenic 
components, like nitrogen dioxide, SCOEL recommended an 8-hour TWA OEL48. For DEE as a 
complex  mixture,  however,  SCOEL  in  its  opinion  of  June  201649  concluded,  that  'an 
occupational exposure level that would be safe for workers could not or not yet be established. 
Both, toxicological information and human epidemiological data are further evaluated in order 
to derive such limits.' 

ACSH proposed an Annex I entry in the case of DEE but limited it to the emissions from older 
types of engine. Further investigations for newer engines would however be needed according to 
the  ACSH  opinion  prior  to  decision  regarding  possible inclusion  in  Annex  I.  The  principle  of 
including  an  OEL  for  DEE  in  Annex  III  was  agreed  subject  to  taking  into  account,  inter  alia, 
feasibility  in  certain  employment  sectors,  in  particular  mining  and  construction  and  taking 
environmental background levels into account in certain workplaces. Nevertheless, no potential 
concrete value has been proposed in the ACSH opinion. 

Differentiation  between  'older'  and  'newer'  type  of  engines  is  relevant  as  the  technological 
progress  and  EU  emission  standards  have  led  over  time  to  a  considerable  change  in  the 
composition of DEE emissions in general, and to its content of carcinogens in particular. IARC, 
in  its  recent  monograph  on  'Diesel  and  Gasoline  Engine  Exhausts  and  some  Nitroarenes'50 
classified  diesel  engine  exhaust  as  'carcinogenic  to  humans'  (Group  1)  but  noted  that  the 
'qualitative and quantitative composition of exhausts depends on the fuel, the type and age of the 
engine, the state of its tuning and maintenance, the emission control system, and pattern of use', 
and that 'in the past two decades, progressively tighter emission standards for on-road vehicles, 
introduced  in  North  America,  Europe,  and  elsewhere,  have  triggered  advances  in  diesel 
technology  that  resulted  in  lower  emission  of  particulate  matter,  nitrogen  oxides,  and 
hydrocarbons.' 

Taking the above mentioned considerations into account it is considered that the ACSH opinion 
has  not  been  sufficiently  consensual,  and  that  there  are  concerns  about  legal  clarity  of  the 
proposal.  

47 The main chemical constituents of diesel engine exhaust emissions are carbon (soot), water , carbon monoxide 
(CO), carbon dioxide (CO2), nitrogen (N2), oxides of nitrogen (NOx), oxides of sulphur such as sulphur dioxide 
(SO2), alcohols, aldehydes, ketones, various hydrocarbons, and polycyclic aromatic hydrocarbons (PAHs). 

48  Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for  Nitrogen  Dioxide, 

SCOEL/SUM/53 of June 2014. 

49  SCOEL/OPIN/2016-403, Diesel Engine Exhaust, June 2016 
50  http://monographs.iarc.fr/ENG/Monographs/vol105/mono105.pdf 

24 

 
                                                 
More specifically, the option of including DEE in Annex I is withheld at this stage because:  

1) the definition of the substance with reference to 'older' or 'traditional' type of engines lacks 
necessary  clarity  from  a  legal  point  of  view  and  would  be  very  difficult,  if  not  impossible,  to 
implement. Furthermore, in formal terms, a reference to the European emissions standards based 
on  Directive  70/220/EEC  combined  with  a  reference  to  a  certain  type  of  engines  was  not 
deemed as complying with the requirements for inclusion under Annex I of the CMD;  

2)  given  the  lack  of  clear  distinction  between  'new'  and  'old'  type  of  engines  it  would  be 
impossible to evaluate the extent of the current use and consequently impacts that inclusion in 
Annex I and the resulting obligation to substitute would have on industry (especially mining and 
SMEs);  
3)  on  15th  September  2016  a  fourth  list  of  indicative  occupational  exposure  limit  values  was 
adopted  in  implementation  of  the  Chemical  Agents  Directive  (CAD,  Council  Directive 
98/24/EC).  This  list  includes  indicative  OELs  for  mono-nitrogen  oxides  (NOx),  which  are  the 
most  notable  non-carcinogenic  hazardous  gases  in  DEE,  and  which  will  require  an  industry 
response  to  control  emissions,  which  will  have  an  additional  beneficial  effect  in  reducing 
exposure of workers to the carcinogenic components in DEE. Analysis of impacts of introducing 
an Annex I entry under CMD requires further consideration of these factors. 

Without  an  Annex  I  entry  defining  the  carcinogen,  it  is  impossible  to  establish  an  OEL  for  a 
PGS  such  as  DEE.  Further  noting  SCOEL's  conclusion  that  establishing  a  'health-based' 
threshold for worker exposure to DEE is currently not possible, that no specific value has been 
reflected  in  the  ACSH  Opinion,  and  that  there  are  practical  difficulties  with  the  measurement 
techniques suggested by the ACSH . 

Amending CMD in relation to DEE is withheld at this stage, pending further investigations into 
whether  a  legally  clear  definition  can  be  proposed.  In  the  meantime  the  Commission  would 
support any relevant sectoral social dialogue – particularly noting the interest of social partners 
in  the  extractive  industries  –  with  a  view  to  establish  good  practices  and  develop  common 
definitions  which  could  eventually  feed  into  future  amendments  and  complement  legislative 
action. Individual components will be analysed with a view to introducing action in relation to 
them in further updates. 

4.2.4. Amending CMD in relation to rubber process dust and fumes (RPDF) 

Working  in  rubber  industry  can  cause  leukaemia  and  cancers  of  the  larynx  and  lung. 
Occupational exposure in the rubber manufacturing industry is classified as group 1 carcinogen 
by IARC. Because rubber process dust and fume are 'process-generated' and are not 'supplied' as 
such they are not subject to classification according to CLP. Rubber process fumes and dust are 
highly complex mixtures, the compositions of which varies considerably, but many studies have 
shown  that  they  contain  carcinogens.  The  presence  and  concentration  of  specific  carcinogens 
depends on the production process and rubber mixture. 

The opinions of the social partners represented in the ACSH differ. The employers prefer to use 
a 'substance by substance' approach and not to include the rubber fumes and rubber process dust 
in  Annex  I,  arguing  that  technological  progress  such  as  an  increased  use  of  closed  processes, 
ventilation  and  increased  automatisation  has  reduced  the  exposure  levels.  Industrial  hygiene 
monitoring of separate substances have also contributed to lower exposure levels. The workers 
representatives  favour  inclusion  of  rubber  fumes  and  dust  in  Annex  I,  and  making  certain 
processes exempt if it can be shown that those processes are free of carcinogens. 

Given the lack of an agreed ACSH position on the most appropriate approach as well as the fact 
that the complexity of the mixtures makes it difficult to establish a sufficiently clear definition, 
amending  CMD  in  relation  to  rubber  process  dust  and  fumes  is  withheld  at  this  time.  At  the 
same time, several known carcinogenic components of rubber process dust and fume – namely 

25 

 
benzene  and  PAHs  –  are  already  subject  to  consideration  for  'carcinogen  specific'  measures 
under CMD. 

4.2.5. Amending CMD in relation to 4,4'-Methylene-bis-(2 chloraniline) (MOCA) 

MOCA has been classified by IARC as carcinogenic to humans (Group 1) and as a Category 1B 
carcinogen  in  the  EU  under  CLP.  It  is  also  associated  with  occupational  asthma  and  chronic 
obstructive  pulmonary  disease.  In  its  pure  form  it  is  solid  at  room  temperature  and  has  low 
volatility.  It  is  easily  absorbed  through  the  skin  and  the  dermal  route  of  exposure  is  the  most 
important. 

SCOEL  and  ACSH  have,  due  to  the  nature  of  the  pattern  of  exposure,  recommended  a 
biological limit value and a skin notation and no airborne OEL.   

However, several  Member States have established inhalation exposure limit values for MOCA, 
ranging  from  0.005  to  0.22  mg/m3.  Moreover,  ECHA's  RAC  has  considered  and  assessed  the 
inhalation route and derived a dose-response curve for the chemical. This assessment will need 
to be taken into account in a future proposal for action with regard to the substance in order to 
ensure the maximum protection of workers and consistency between the approach under CMD 
and REACH. 

Finally, the use of biological limit value, in particular in the framework of the CMD, needs to be 
discussed and agreed and the Commission will explore the possibilities on how best to address 
this issue. 

4.3  Discarded options 

Several  other  options  have  been  discarded  as  they  were  considered  disproportionate  or  less 
effective in reaching the objectives of this initiative. These options are listed below. The reasons 
for discarding A, B and C are detailed in the previous IA. 

A. Banning the use of the carcinogenic chemical agents 

B. Providing industry-specific scientific information without amending CMD 

C. Market-based instruments 

D.  Industry self-regulation 

A ‘Charter for the safe use of Trichloroethylene in metal cleaning’ established by the European 
Chlorinated  Solvents  Association  'represents  a  voluntary  agreement  open  for  signature  by 
producers  and  importers'  of  TCE  as  a  'voluntary  industry-wide  commitment  ensure  adequate 
control of risks related to use of trichloroethylene' as identified in an earlier EU risk assessment 
with  a  view  to  'safeguard  the  long-term  sustainable  use  of  trichloroethylene  in  closed-systems 
for metal cleansing'.51 

The ECSA Charter stipulates that, since the end of 2010, trichloroethylene is only supplied by 
signatories for metal cleaning or degreasing if the user has an enclosed cleaning system and has 
confirmed  that  trichloroethylene  will  only  and  exclusively  be  used  in  enclosed  cleaning 
equipment. It has been signed by all European Trichloroethylene producers and an importer. 

While the ECSA Charter is a welcome initiative, it should be noted that the effectiveness of self-
regulation is hindered by the following: 

 

it does not apply to all uses of TCE; 

  TCE importation the EU is not heavily represented; and 

51 http://www.dow.com/scripts/litorder.asp?filepath=safechem/pdfs/noreg/773-12001.pdf 

26 

 
 
                                                 
 

it is not binding and cannot therefore be enforced by national authorities. 

Consequently, the ECSA Charter, while an important and valuable industry measure signalling 
positive intention, is not considered as effective as CMD amendments in setting and enforcing 
minimum protection for workers across the EU and in all sectors of industry. 

E. Regulation under other EU instruments (REACH) 

Both CMD and the REACH Regulation are relevant for worker protection from the majority of 
carcinogens considered in this assessment. 

REACH is a relevant regulatory instrument for protection of workers from hazardous chemicals, 
including in particular chemical carcinogens 

REACH and the OSH Directives are complementary, and clear synergies between REACH and 
worker protection legislation can  be seen  – these are set  out in  more detail in section 3.2.2 of 
this supplementary IA and sections 2.3 and 14.2 of the earlier full IA. 

In the case of the present proposal, CMD is the more appropriate regulatory instrument. Among 
the  reasons  in  support  of  this  approach  there  is  the  fact  that  CMD  covers  worker  exposure  to 
carcinogenic  agents  released  by  any  work  activity,  whether produced  intentionally or  not,  and 
whether available on the market or not, such as process generated substances in the workplace. 
Furthermore,  CMD  is  intended  to  set  OELs,  which  are  an  important  part  of  the  wider  OSH 
approach to managing chemical risks52. 

F. Directly adopting the most stringent national OEL 

For most of the carcinogens some Member States adopted OELs more stringent than considered 
in this proposal. It could be argued that workers' protection could be further improved if such 
OELs were to be made binding across the EU based on an assumption that what is achievable in 
one Member State should be achievable in all. However, a more stringent OEL may exist in a 
Member State where, for example, certain industries or industrial processes are less prominent 
or even not present or where the structure of the industry is different (e.g. relatively less SMEs). 
Also,  there  may  be  significant  differences  as  for  access  to  and  affordability  of  new  exposure 
control technologies.  Such an assumption is therefore incomplete. 

The  EU  sets  minimum  standards  in  this  area  and  OELs  need  to  be  seen  in  the  context  of  the 
minimisation principle. This means that Member States are encouraged to establish limit values 
which are more protective than the EU OELs and that industries have the obligation to minimise 
exposure below existing OELs if that is technically feasible.   

4.4  Options and carcinogens retained for consideration 

Table 3 below summarises different policy options for each of the seven chemical agents, which 
are subject to further impact assessment. 

A baseline scenario of no further EU action is Option 1 for each chemical agent represented in 
this  initiative.  Directly  reflecting  the  Opinion  agreed  by  the  ACSH,  forms  Option  2  for  each 
chemical agent. 

Where  appropriate  and  depending  on  specific  characteristics  of  the  agents,  flanking  options 
which, compared  with the ACSH Opinion,  provide for either  lower (more stringent) or  higher 
(less stringent) EU legal requirements, are presented as Option 3 and/or 4 respectively for each 
chemical  agent.  These  flanking  options  are  drawn  from  the  IOM  study,  for  which  they  were 
established  by  preference:  i)  from  a  SCOEL  Recommendation  if  available;  ii)  as  OEL  values 
reflecting available data (for example taking account of existing national OELs); or  iii) on the 

52  See also section 3.2.2 and 15.2.1 of this document. For a detailed analysis of the differences between CMD and 

REACH see section 4.2, page 34, of SWD(2016)152/2. 

27 

 
                                                 
basis of recommendations from the contractor (for example taking into account non-EU OELs). 
Where available data do not support flanking options, these options are discounted. 

In  addition,  for  each  chemical  agent  where  SCOEL  has  identified  significant  risk  of  adverse 
systemic  effects  from  non-inhalation  exposures  the  options  are  augmented  with  'notations' 
indicating dermal risk in the form of a 'skin notation' ('sk.').  
Table 3. Options matrix53 

Carcinogen 

Option 1 
(baseline) 

Epichlorohydrine (ECH) 

n/a 

Ethylene dibromide 
(EDB) 

Ethylene dichloride 
(EDC) 

4,4'-Methylenedianiline 
(MDA) 

n/a 

n/a 

n/a 

Trichloroethylene (TCE)  n/a 

Option 2 
(ACSH opinion) 
(mg/m3and  ppm  – 
parts per m)54,55,56 
Annex III entry 
1.9 mg/m3 
Sk. 
Annex III entry 
0.8 mg/m3 
(0.1 ppm) 
Sk. 
Annex III entry 
 8.2 mg/m3 
(2 ppm) 
Sk. 
Annex III entry 
0.08 mg/m3 
Sk. 
Annex III entry 
8TWA 54.7 mg/m3  
(10 ppm) 
STEL 164.1 mg/m3 
(30 ppm) 
Sk. 
Annex III entry 
Sk. 

Option 3 
(more stringent) 
(mg/m3and  ppm  – 
parts per m) 
n/a 

Option 4 
(less stringent) 
(mg/m3and  ppm  – 
parts per m) 
n/a 

n/a 

n/a 

Annex III entry 
 4.1 mg/m3 
(1 ppm) 
Sk. 
n/a 

n/a 

Annex III entry 
0.002 mg/m3 
Sk. 
n/a 

Annex III entry 
20.5 mg/m3 
(5 ppm) 
Sk. 
Annex III entry 
0.8 mg/m3 
Sk. 
Annex III entry 
8TWA 273.5 mg/m3 
(50 ppm) 
STEL 164.1 mg/m3 
(30 ppm) 
Sk. 
n/a 

n/a 

n/a 

Complex PAH mixtures 
with benzo[a]pyrene as an 
indicator 
Mineral Oils as Used Engine 
Oils (UEO) 

n/a 

Annex I entry 

Annex III entry 
Sk. 

53  OELs at 8hr TWA unless otherwise stated. 
54  The values are presented as adopted in the ACSH opinions (either only expressed in ppm or mg/m3 respectively) 

or converted in one (ppm to mg/m3) or the other direction (mg/m3 to ppm) 

55  A  conversion  from  mg/m3  to  ppm  only  makes  sense  for  substances  which,  at  room  temperature  and  normal 

atmospheric pressure, exist as a gas or vapour.  

56  The conversion factors used in this table are based on the conversion factors provided in the relevant SCOEL 
recommendations, and are rounded to one digit after the decimal point. Therefore they can slightly deviate from 
the values proposed in the ACSH opinions. 

28 

 
 
 
 
 
                                                 
5  WHAT  ARE  THE  IMPACTS  OF  THE  DIFFERENT  POLICY  OPTIONS  AND  HOW  DO  THEY 

COMPARE? 

5.1  Study methodology 
Different policy options have been compared based on the following methodology57: 

  The  introduction  of  a  measure  is  expected  to  result  in  a  reduction  in  the  occupational 
exposure to the carcinogen concerned. The extent of such reduction depends on the current 
levels of exposure, as well as on the projected future levels of exposure in the absence of the 
proposed measure, i.e. the 'Baseline scenario', corresponding to Option 1. Depending on the 
specific  situation  with  regard  to  each  chemical  (past  trends,  state  of  technological 
developments etc.), the baseline scenario taken from the IOM study foresees static baselines 
(i.e.  where  no  changes  in  exposures  were  expected  beyond  2010)  or  dynamic  ones,  where 
current  trends  (e.g.  4%  annual  reduction)  is  expected  to  continue  till  at  least  2030.  This 
projection  of  future  exposure  levels  is  obtained  by  extrapolating  past  declining  trends  in 
average  exposure  levels.  It  should  be  noted  that  any  assumed  exposure  reductions  refer  to 
the  geometric  mean  exposure levels  (i.e.  intensity  of  exposure)  rather  than  the  numbers  of 
workers  exposed.  Further  information  on  how  baselines  were  defined  in  the  study  can  be 
found in annex 5 (especially sections 12.1 and 12.2). 

  For  a  given  reduction in  exposure  levels,  the  expected  decrease in  the  incidence  of  cancer 
cases  is  estimated  over  a  given  timeframe  attributable  to  the  carcinogen  in  question.  This 
requires  estimates  of  the  risk  of  carcinogenicity,  which  can  be  derived  from  the  existing 
toxicological and epidemiological literature, as well as information about the actual level of 
worker  exposure  (numbers,  level,  duration  and  frequency  of  exposure).  The  available 
epidemiologic  evidence  is  however  scarce  and  not  always  sufficiently  robust,  inevitably 
affecting  the  reliability of the derived estimates  for the number of cancer registrations and 
deaths. 

  The  health  benefits  of  avoided  cancer  registrations  and  deaths  can  then  be  expressed  in 
monetary terms  by  applying  standard  evaluation  methods.  The  valuation  of  health  impacts 
was undertaken based on two approaches. In the low scenario, the estimate per incident is 
made of its Value of Life Years Lost and the related Cost of Illness (including in that case 
direct, indirect and intangible costs). In the alternative, high scenario the Willingness To Pay 
(WTP)  approach  was  applied  as  the  only  value  per  incident  case.  The  WTP  approach 
typically reflects what people are willing to pay to avoid having cancer (both fatal and non-
fatal).  This  under  the  assumption  of  the  study  includes  such  items  as:  lost  wages,  medical 
expenses,  the  monetary  value  of  the  disutility  of  illness  and  the  impact  of  preventive 
expenditures. The WTP estimate for fatal cancers was used (1,793,776 EUR) in most cases. 
For  the  non-melanoma  skin  cancer    a  lower  WTP  was  used  (38,827  EUR).  Those  values 
were  derived  from  the  sources  and  guidance  available  at  the  time  the  study  was 
undertaken58. A more recent OECD study59, summarising a four year-effort to compile and 
analyse  the  largest  database  to  date  containing  all  studies  based  on  the  States  Preference 
method that have been prepared around the world, proposes a range of 1.8-5.4 million (2005 
USD)  for  the  average  adult  VSL  for  EU-27,  with  a  base  value  of  3.6  million  USD.  In 
parallel, a study commissioned recently by the European Chemicals Agency (ECHA), found 

57 Unless indicated otherwise, the main source for the data and analysis presented in the following sections is the 

IOM study. 

58 This includes in particular the values referred to in Rabl (2004) – 'Valuation of Health End Points for Children 
and  for  Adults',  Working  Paper  and  the  values  referred  to  in  the  2009  version  of  the  EC  Impact  Assessment 
Guidance.  

59  OECD (2012), Mortality Risk Valuation in Environment, Health and Transport Policies, OECD Publishing. 

29 

 
                                                 
that  the  WTP  values  for  a  premature  cancer  death  ranges  between  3,500,000-5,000,000 
EUR.60 This points to a possible underestimation of the benefits as computed under the IOM 
study. 

  These monetised health benefits can in turn be compared to the expected monetary costs that 
would have to be incurred in order to comply with the proposed OEL. The estimate of the 
costs was made based on a literature research and data obtained from stakeholder contacts 
and  take  into  account  the  following  factors:  the  number  of  firms  needing  to  apply  the 
relevant  Risk  Management  Measures  (RMMs)  and  the  costs  of  these  RMMs  over  the 
considered period; the costs of administrative procedures of implementing the OELs (such 
as the costs of monitoring and audit); the potential effect on the market for the substance by 
the imposition of the OEL.  

5.1.1. Analytical challenges 
As explained in more detail in the previous IA61 and in Annex 5 (section 12.4) the cost-benefit 
analysis poses numerous challenges, related, inter alia, to the long latency of cancers, scarcity of 
reliable data on exposures and effects of existing obligations on employers. 

Evolution in exposure 

Exposure estimates, derived from the IOM study, are based on the assumption that for many of 
the  concerned  chemical  agents,  past  trends  of  declining  exposures  will  continue.  These  trends 
were  related  to  technological  progress,  changes  in  work  organisation  and  relative  weight  of 
different industrial sectors but also to past legislative developments.  

It is difficult to predict whether such trends would indeed continue in the absence of further EU 
action. The 60-year time frame of the assessment poses also the challenge of anticipating future 
industrial  developments.  For  each  of  the  carcinogens  several  industry  sectors  are  relevant,  in 
total a high number of very diverse sectors are concerned (from e.g. car maintenance, through 
pharmaceutical  industry,  mining,  steel  production,  asphalt  production,  textile  manufacture, 
rubber and plastic industries). Analysing technological developments and making more detailed 
forecasts as for expected evolution for all these diverse sectors would pose a lot of challenges. 
As many and 

These  industries  are  impacted  by  diverse  developments  impact  these  industries,  such  as 
technical inventions, oil prices, market structure etc., we cannot predict how all those things will 
impact the baseline.. The uses of the chemical agents under consideration could either decline or 
grow and potential new uses could lead to new workplace risks.  

In  addition,  even  when  declining  trends  in  average  exposure  levels  are  observed,  it  may  be 
misleading  to  regard  these  as  exogenous.  Recent  reductions  in  exposure  may  have  been 
precisely the result of OELs having been introduced or as an anticipation of those changes.  

Moreover,  a  2016  report  by  the  Netherlands  National  Institute  for  Public  Health  and  the 
Environment  (RIVM)62  indicates  that,  despite  projected  declining  exposure  levels,  'forecast 
impacts will probably not be lower than those of 2012' (p. 36). 

Period for estimation 

60  Valuing selected health impacts of chemicals, ECHA (2016).  Summary of the results and a critical review of the 
ECHA  study,  p.  32.    See:    https://echa.europa.eu/support/socio-economic-analysis-in-reach/willingness-to-pay-
to-avoid-certain-health-impacts 

61  Section 5, p. 34-37 of SWD(2016)152/2 
62  Work-related  cancer 

in 

the  European  Union 

:  Size, 

impact  and  options  for  further  prevention, 

http://rivm.nl/en/Documents_and_publications/Scientific/Reports/2016/mei/Work_related_cancer_in_the_Europ
ean_Union_Size_impact_and_options_for_further_prevention, p. 11 

30 

 
                                                 
The  period  of  estimation  was  set  in  order  to  take  into  account  the  long  risk  exposure  period 
(REP) for specific types of cancer:  for solid tumours a latency of 10-50 years was assumed and 
for haematopoietic neoplasms a latency of 0-20 years was assumed. The future cancer burden is 
estimated over a 60 years period.  

Reliable and timely data 

First  of  all,  for  most  chemical  agents  under  consideration,  data  on  the  number  of  workers 
exposed is scarce and unreliable (especially for some sectors and/or for some Member States), 
and  data  on  the  current  exposure  levels  across  EU  Member  States  is  generally  not  available. 
Member  States  record  statistics  relating  to  cancer  in  different  ways  which  cannot  be  readily 
aggregated.63  Where  exposure  data  is  available,  its  use  as  an  evidence  base  for  regulatory 
decision-making is often confounded by the sensitive and sometimes confidential nature of the 
information,  and  the  potential  for  source  bias.  This  lack  of  data  is  recognized  and  in  order  to 
address this data gap the Commission initiated a study in 201364. The outcome of this work is 
expected  to  contribute  to  a  better  definition  of  the  baseline  situation  for  possible  future 
initiatives. 

Secondly,  the  available  epidemiologic  evidence  is  scarce  and  not  always  sufficiently  robust, 
inevitably affecting the reliability of the derived estimates for the number of cancer registrations 
and deaths. Among the factors contributing to the scarcity of reliable data are the complexity of 
cancer development and also of workplace exposures. Different carcinogens can, for example, 
result  in  the  same  type  of  cancer  (e.g.  lung  cancer),  and  occupational  exposure  to  hazardous 
agents is characterised by simultaneous exposure to multiple chemical agents. It can therefore be 
difficult  to  establish  a  causal  relationship  between  cancer  cases  and  exposure  to  a  specific 
carcinogen.  Moreover,  occupational  cancers  may  develop  decades  after  exposures  –  including 
during  retirement  –  complicating  the  possibility  of  identifying  a  causal  link.  This  also  has  a 
significantly negative impact on potential to improve evidence base for future proposals.  
As explained in more detail in the previous IA65 and in Annex 5 (section 12.4) these challenges 
and the fact that effects of diseases other than cancer which may be caused by the chemicals are 
not taken into account explain why health benefits are likely to be underestimated. 

5.1.2. General remarks 

Analysis of impacts on Member States, competitiveness, and proportionality 

For  each  of  the  seven  carcinogens,  an  analysis  of  possible  policy  options  is  presented  by 
chemical agent in the following sub-sections66. 

63  Regulation  (EC)  No  1338/2008  aims  to  adopt  implementing  measures  for  the  relevant  domains,  including 
occupational  diseases,  provided  that  the  intended  data  is  found  to  be  of  sufficient  quality.  The  implementing 
measure would require Member States to supply the Commission with statistics on occupational diseases. CMD 
Article  14(8)  requires  that  data  on  cases  of  cancer  resulting  from  occupational  exposure  be  notified  to  the 
competent national authorities.  Statistical practices, however, vary between Member States. 

64  Call  for  tender  no.  VT/2013/079.  Service  contract  to  create  a  database  and  develop  a  model  to  estimate  the 
occupational  exposure  for  a  list  of  hazardous  chemicals  in  the  Member  States  of  the  European  Union  and  the 
EFTA/EEA countries.  The contract with the successful bidder, VC/2014/0584, was signed on 23 July 2014. 

65  Section 5, p. 34-37 of SWD(2016)152/2 
66  Unless  otherwise  specified,  all  data  in  the  agent-specific  analysis  comes  from  the  IOM  study,  with  reference 

periods as specified in that study. 

31 

 
 
 
                                                 
The  IOM  study  identifies  the  number  of  EU  workers  exposed  to  each  chemical  agent  and,  in 
most  cases,  also  identifies  exposed  working  populations  by  Member  States.  An  illustration  of 
the OELs in place at national level is provided in Annex 10, as well as the estimated number of 
workers potentially exposed by Member State. Furthermore, Table 4 in Annex 7 identifies the 
population of workers occupationally exposed to each chemical agent in Member States having 
no  OEL  or  less  stringent  OELs,  and  compares  this  to  the  overall  EU  population  of  exposed 
workers, resulting in the percentage of workers in the EU for whom legal protection would be 
improved by adoption at EU level of an OEL under CMD. 

In addition to consideration at section 6.2.2 of impacts on competition and competitiveness for 
the  package  of  retained options,  a  brief  reference  to  non-EU  countries'  OELs  is  given  in  each 
sub-section. 

Costs related to skin notations 

In  order  to  effectively  control  total  systemic  exposure  to  chemicals  at  the  workplace,  it  is 
necessary  to  take  account  not  only  of  exposure  by  the  inhalation  route,  but  also  of  dermal 
exposure,  which  may  lead  to  skin  penetration  and  a  consequent  increase  in  the  total  body 
burden. It is therefore in some cases necessary to assign a ‘skin notation’ to some carcinogens in 
order to warn of the possible significant contribution of dermal absorption. 

A SCOEL recommendation for a skin notation is not related to CLP dermal hazard classification 
- it is not intended to give warning of, for example, direct effects on the skin such as corrosivity, 
irritation, and sensitisation. 

Nevertheless,  of  the  seven  carcinogens  considered  for  the  allocation  of  'skin'  notations  in  the 
retained options below, six are supplied in the EU bearing hazard warnings relating to dermal 
exposure.  As a result of these hazard classifications employers should already be taking steps to 
manage  risks  to  workers  by  avoiding  dermal  exposure  –  compliance  costs  for  employers  (if 
any)  should therefore be minimal. 

The  main  positive  effect  of  establishing  a  skin  notation  is  that  employers  should  thereby  be 
alerted that a considerable part of the 'body burden' is the result of the uptake via the skin, and 
that  biological  monitoring  would,  if  possible,  be  a  valuable  additional  tool  to  ensure  that 
adequate risk management measures are in place. 

Where  the  IOM  study  or  this  analysis  have  identified  particular  additional  costs  or  benefits 
resulting  from  assigning  a  skin  notation  to  a  given  carcinogen  these  are  addressed  in  the 
appropriate sections below. 

A  more  detailed  account  of  general  OEL  policy  considerations,  including  skin  notations,  is 
given in Annex 4 at section 11.2.2. 

Comparison key 

The comparison tables used in the following sections apply the following ranking symbols: '0' – 
baseline,  '≈'  –  similar  to  baseline,  '+'  more  efficient/effective  or  coherent  than  baseline;  '++'  – 
much more efficient/effective or coherent than baseline; '-' – less efficient/effective or coherent 
than baseline; '- -' – much less efficient/effective or coherent than baseline. 

5.2  Epichlorohydrine (ECH) 

Beside its probable carcinogenicity to humans, epichlorohydrine in liquid form has been found 
to cause skin burns and the vapour can cause irritation of the eyes, nose and throat. 

Workers’  inhalation  and  dermal  exposures  are  controlled  via  the  use  of  closed  systems  with 
engineering controls such as vapour return lines during product transfer, the dry disconnect style 
of fittings for transfer hoses and automated sampling systems. Personal protective equipment is 

32 

 
 
also  used  to  reduce  exposure.  Significant  exposures  are  therefore  likely  to  occur  only  during 
maintenance activities, or during accidental releases. 

There  are  15  high  volume  (>1,000 
importers  of 
epichlorohydrine  within  the  European  Union  in  the  following  member  states:  Germany  (4), 
Netherlands  (3),  United  Kingdom  (2),  Italy  (2),  Sweden  (1),  Finland  (1),  Austria  (1)  and 
Belgium (1).67 Annual production in the EU is estimated at around 360,000 tonnes per annum, 
while  annual  global  production  is  estimated  at  around  900,000  tonnes.  The  total  estimated 
number of exposed workers in the EU is 43,813. 

tonnes  per  annum)  producers  or 

Table 4. Epichlorohydrine – Types of impacts 

Impact  Option 1: 

Baseline 

It is assumed that exposure levels remain the 
same68 and that firms will not incur costs to 
reduce exposure under the baseline scenario. 

Option 2:  

Annex III entry 
1.9 mg/m3 (0.5 ppm) 
Sk. 

It is estimated that, under the baseline 
scenario, firms are already achieving 
exposures less than 1.9 mg/m3. Therefore 
no significant additional costs are expected 
to meet the OEL, nor is negative impact on 
competitiveness anticipated. 

As per 'General remarks' skin notations 
should not result in additional cost as 
employers should already under the 
baseline be taking steps to manage risks to 
workers by avoiding dermal exposure. 

No impact on employment is expected. 

The total number of attributable deaths for 2010-
2069 is estimated to 2430, including both lung 
and central nervous system (CNS) cancers. There 
is an estimated increase of the number of 
predicted attributable deaths throughout this 
period, entirely due to the increase in the 
longevity of the population. 

No significant health costs or benefits 
compared to the baseline are expected with 
the introduction of the OEL, as exposure is 
already estimated to be below the value. 

Skin notations may be expected to improve 
awareness and enforceability. 

The corresponding health costs are estimated to 
be between €1362m and €2752m. 

YLLs are estimated to increase over the period, 
from 317 to 426 years per annum for lung 
cancer, and from 324 to 388 years per annum for 
CNS cancer. 

No significant impact  

No significant impact  

67  Source: European Commission Institute for Health and Consumer Protection (2010) 
68  There is very little evidence of change in exposure levels since the 1980s in the data identified by the IOM study. 
Given the relatively low level of exposure, the IOM study assumes that the exposure levels haven been stable 
since at least 1980.  

33 

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Prevalence was estimated in the IOM study using the 2006 Labour Force Survey and the 2006 
data  from  the  Structural  Business  Statistics  to  estimate  the  proportion  of  employees  in  each 
industry.  It  was  not  possible  to  use  CAREX  data  as  epichlorohydrine  was  not  included  in  the 
2007  update.  It  is  likely  that  all  European  facilities  have  already  achieved  a  level  of  control 
equal or below 1.9 mg/m3. 

Table 5. Epichlorohydrine – Comparison of options 

Criteria 

Option 1: 

Baseline 

Option 2:  

Annex III entry 
1.9 mg/m3 (0.5 ppm) 
Sk. 

≈ (OEL likely already achieved in 
practice) 

≈ (no significant additional costs) 

+ 

0 

0 

0 

Effectiveness 

Efficiency 

Coherence 

Scientific advice 
(SCOEL)  
(Adopted 2011) 69 

ACSH 

Epichlorohydrine is categorised into the SCOEL carcinogen group 
A as a non-threshold carcinogen. 

SCOEL strongly recommends avoiding occupational exposure to 
epichlorohydrine. 

SCOEL has also proposed a skin notation. 

SCOEL, in it is Recommendation (SCOEL SUM 169), concluded 
that it is not possible to derive a health based OEL. SCOEL makes 
reference to quantitative data on carcinogenicity as assessed by the 
Dutch Expert Committee on Occupational Standards (DECOS) on 
the estimated additional lifetime cancer risk  
An 8hr TWA of 1.9 mg/m3 is proposed.  

In  the  case  of  epichlorohydrine,  in-depth  discussions  between  the  representatives  of  workers, 
employers  and  governments  in  the  ACSH  resulted  in  an  agreement  to  propose  an  OEL  as  in 
option  2.  No  concerns  about  technical  feasibility,  overall  costs  or  impact  on  competitiveness 
outside  the EU  have  been  raised  by  employers'  representatives  or  government  representatives. 
The fact that SCOEL could not, based on the available data, derive a health-based OEL has been 
taken into consideration in the discussions in the ACSH during which an agreement was reached 
on the numerical value of the proposed OEL. 

The  impact assessment confirms  that  the  option  supported  by  the  ACSH  opinion (OEL  of  1.9 
mg/m3) is appropriate. According to the available data this exposure level is likely to have been 
achieved in practice. While no immediate health benefits are identified on the basis of current 
knowledge,  introduction  of  an  OEL  with  a  skin  notation  as  recommended  by  SCOEL  would 
ensure legal protection for workers and enhanced clarity for enforcers and economic operators. 
Option 2 is therefore the preferred option. 

69  SCOEL/SUM/169, September 2011 

34 

 
 
 
 
 
                                                 
Impact on Member States, competitiveness, and proportionality 

In the case of epichlorohydrine, 15 Member States will need to introduce (7) or update (8) their 
OEL  to  bring  it  down  to  1.9  mg/m3  (see  table  2  of  Annex  7  and  Annex  10).  Around  69%  of 
exposed  workers  are  estimated  to  work  in  those  15  Member  States  and  would  consequently 
benefit from improved legal protection as a result of the introduction of this OEL. 

Non-EU countries have established a wide range of exposure values. This OEL is equivalent to 
that  in  place  in  countries  such  as  New  Zealand  and  South  Korea,  although  more  stringent 
(China) and less stringent OELs (e.g. US, Australia, Singapore) are applied in some other third 
countries.  As indicated above no significant impact on competitiveness is expected. 

5.3  Ethylene dibromide (EDB) 

Ethylene  dibromide  (EDB)  is 
classified  as  a  Category  1B 
carcinogen  according  to  CLP, 
and  has  been  identified  as  a 
Group  2A  carcinogen  by 
IARC.  EDB 
is  categorised 
into  the  SCOEL  carcinogen 
group  A  as  a  genotoxic 
carcinogen 
a 
threshold.  EDB  is  strongly 
irritant  to  the  eyes,  skin  and 
respiratory  tract,  and  acute 
exposure (200 mg/kg) is lethal 
to humans. 

without 

intermediate 

EDB  is  currently  used  as  a 
chemical 
in 
synthesis  and  as  a  non-
flammable  solvent  for  resins,  gums  and  waxes.  The  major  chemical  made  from  EDB  is  vinyl 
bromide.  EDB  has  also  been  used  as  an  intermediate  in  the  preparation  of  dyes  and 
pharmaceuticals. An important use of EDB has been as a lead scavenger in 'antiknock' mixtures 
added  to  gasolines,  although  this  use  has  decreased  with  banning  the  use  of  lead-containing 
fuels in many countries.  

In  this  context,  it  is  important  to  notice,  that  ECHA,  in  its  recent  Risk  Management  Option 
Analysis  (RMOA)  for  EDB  of  16  July  2015  came  to  the  conclusion,  that  'The  substance  is 
registered for uses within the scope of authorisation (i.e. formulation of anti-knock additive into 
aviation  fuels  and  potentially  some  non-intermediate  use  in  fine  chemicals/pharmaceutical 
manufacture).  The  substance  could  be  proposed  to  be  identified  as  a  Substance  of  Very  High 
Concern  to  be  included  in  the  Candidate  List  for  potential  prioritisation  to  Annex  XIV. 
However,  the  European Commission  considers  that  it  is  more  appropriate  to  address  the  main 
non-intermediate use of the substance, i.e. additive in leaded aviation gasoline, at international 
level and/or under other EU legislation than REACH.'70 
According  to  ECHA71,  this  substance  has  three  active  registrations  under  REACH,  one  Joint 
Submission(s)  and  no  Individual  Submission(s).  It  is  manufactured  and/or  imported  in  the 
European  Economic  Area  in  1,000  –  10,000  tonnes  per  year.  Under  8,000  EU  workers  are 

70  https://www.echa.europa.eu/documents/10162/317e9caf-b149-46f7-847f-189a3d42cdb7  
71  http://echa.europa.eu/brief-profile/-/briefprofile/100.003.132 

35 

 
 
                                                 
estimated  to  be  potentially  exposed  to  1,2-dibromoethane.  Out  of  them,  about  100  workers 
employed in the chemical manufacturing sector would be confronted with potentially high levels 
of exposure. 

Table 6. Ethylene dibromide (EDB) – Types of impacts 

Impact  Option 1: 

Option 2:  

Baseline 

Annex III entry 
0.8 mg/m3 (0.1 ppm) 
Sk. 

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A 7% annual decline in 
average exposure is assumed 
under the baseline. 

It is estimated that less than 1% of enterprises in the chemical 
manufacturing sector would be affected. 

The total cost of anticipating investment, which is assumed to take 
place gradually also under the baseline scenario, is in the range of 
€30-170k.  A majority of companies will incur costs related either 
to appropriate use of respiratory equipment (€0.5k-2k, per 
company per year), possibly combined with a better use of 
ventilation systems (€3k-7k, per company per year). 

The additional costs for companies are in practice expected to be 
very low, as the vast majority of companies have appropriate risk 
management measures already in place. There is no risk of 
closures or competitiveness losses. Consequently, there are no 
risks for employment. 

As per 'General remarks' skin notations should not result in 
additional cost  

No health impact 
quantification possible. 

No health impact quantification possible72. Better use of 
protective equipment and ventilation systems is expected to have 
a positive (although modest) impact on health. 

Skin notations may be expected to improve awareness and 
enforceability. 

No significant impact  

No significant impact  

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72  No health impact could be quantified due to the unavailability of robust data. Further efforts to obtain that data 
would  have  been  disproportionate.  However,  given  the  intrinsic  properties  of  the  carcinogen  and  the  adverse 
health consequences of occupational exposure it is necessary to ensure a high [or appropriate] level of control at 
individual workplaces. Since exposures can occur across a broad range of types of workplace a generic marker 
for exposure control, such as an OEL, is appropriate. 

36 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
According  to  the  estimations  performed  in  the  IOM  study  about  8%  of  workers  in  chemical 
manufacturing  are  exposed  to  average  levels  above  0.1  ppm.  Estimates  of  current  exposure 
levels  were  obtained  by  extrapolating  data  from  existing  studies  conducted  in  the  1990s, 
assuming an average annual reduction in exposure of 7%. 

Due to the limited epidemiological information regarding the carcinogenic effects of EDB, it is 
not  possible  to  identify  appropriate  relative  risks  in  order  to  quantify  the  health  impacts  of 
introducing new exposure limits. 

Even if majority of companies affected are micro- and small enterprises, compliance costs are 
expected to be very low and affordable, as the vast majority of companies have appropriate risk 
management measures already in place. It is therefore assumed that the introduction of an OEL 
of  0.8  mg/m3  would  not  imply  any  important  costs  associated  with  compliance,  neither  major 
social,  macro-economic  or  significant  environmental  impact.  All  interest  groups  (employers, 
employees  and  governmental)  of  the  ACSH  agreed  that  the  proposed  OEL  does  not  present  a 
difficulty because the predicted costs of compliance are low. 

Table 7. EDB – Comparison of options 
Criteria 

Option 1: 

Baseline 

0 

0 

0 

Effectiveness 

Efficiency 

Coherence 

Scientific advice 
(SCOEL)  
(Adopted 2011) 73 

ACSH 

Option 2:  

Annex III entry 
0.8 mg/m3 (0.1 ppm) 
Sk. 

≈/+ (modest improvement of protection) 

≈ (very low additional costs) 

+ 

SCOEL, in it is Recommendation (SCOEL SUM 166), concluded that 
EDB is both a local and systemic experimental carcinogen, its mode of 
action is clearly genotoxic, and it is categorised as carcinogen group A, 
meaning  a  non-threshold  carcinogen.  SCOEL  strongly  recommends 
avoiding  occupational  exposure  to  ECH.  The  quantitative  data  on 
carcinogenicity  and  the  present  state  of  toxicokinetic  inter-species 
modelling  do  not  permit  a  reasonable  and  reliable  quantitative  cancer 
risk assessment for humans  to  be  derived and for this reason SCOEL 
did not propose a numerical value for an OEL. 

A 'skin' notation is justified. 
0.8 mg/m3. The opinion of the workers group is that a reduction of the 
proposed  value  should  be  striven  for  within  a  review  period  of  not 
more than three years. 

In the case of EDB, in-depth discussions between the representatives of workers, employers and 
governments  in  the  ACSH  resulted  in  agreement  that  the  proposed  OEL  as  in  option  2 
represents  a  pragmatic  risk  management  measure.  No  concerns  about  technical  feasibility, 
overall  costs  or  impact  on  competitiveness  outside  the  EU  have  been  raised  by  employers'  or 
governments' representatives. Workers' representatives indicated that the limit value should be 
further  reduced  at  a  future  date.  The  fact  that,  based  on  the  available  data,  SCOEL  could  not 
derive a reasonable and reliable quantitative cancer risk assessment for humans, has been taken 

73  SCOEL/SUM/166, March 2011 

37 

 
 
 
                                                 
into consideration in the discussions in the ACSH during which an agreement was reached  on 
the numerical value of the proposed OEL. 

The  impact assessment confirms  that  the  option  supported  by  the  ACSH  opinion (OEL  of  0.8 
mg/m3) is appropriate. Introduction of an OEL with a skin notation as recommended by SCOEL 
could  entail  some  health  benefits  (though  quantification  of  those  is  not  possible)  and  would 
ensure legal protection for workers and enhanced clarity for enforcers and economic operators. 
Option 2 is therefore the preferred option. This is also in line with the conclusions drawn in 
the RMOA of ECHA for EDB. 

Impact on Member States, competitiveness, and proportionality 

In the case of EDB, 20 Member States will need to introduce (11) or update (9) their OEL to 
bring it down to 0.8 mg/m3 (see annexes 7 and 10). 81% of exposed workers are estimated to 
work in those 20 Member States (see table 4 of Annex 7) and would consequently benefit from 
improved legal protection as a result of the introduction of this OEL. 

Few non-EU countries have established exposure values and for those who have, the values are 
higher than the retained option, except in one case for US-NIOSH (0.045 ppm).  No concerns 
about impact on competitiveness outside the EU have been raised.  

5.4  Ethylene dichloride (EDC) 

Ethylene dichloride (EDC) is classified as carcinogen (IARC Group 2B and CLP Category 1B) 
for  its  carcinogenic  effects  at  multiple  sites  in  rats  and  mice,  both  by  oral  dosing  and  by 
inhalation. Next to its carcinogenic properties, EDC is a highly flammable liquid and vapour, is 
harmful  if  swallowed,  causes  serious  eye  irritation,  causes  skin  irritation  and  may  cause 
respiratory irritation. Additionally, it is toxic if inhaled. 

The  substance  is  subject  to  REACH  Authorisation  based  on  its  carcinogenic  properties,  and 
included as entry 26 in Annex XIV to the REACH Regulation. The so-called sunset date74 for 
the substance is 22 November 2017. The deadline for submitting applications for authorisation 
was  22  May  2016.  10  applications  have  been  submitted  by  that  deadline.  For  the  purpose  of 
analysis  it  is  assumed  that  all  uses  of  EDC  which  are  in  scope  of  REACH  authorisation  are 
subject  to  effective  worker  protection  which  has  been  duly  considered  by  the  European 
Chemicals Agency (ECHA) Committees and the European Commission. 

However, the main use of EDC (more than 95% of the total volume) is as an intermediate on 
site in the synthesis of vinyl chloride monomer (VCM). Use as an (transported) intermediate for 
VCM synthesis represents more than 4% of the total amount of EDC. In addition, small amounts 
tri-  and 
are  also  used  as  an 
tetrachloroethylene  and  other  chlorinated  solvents  and  as  a  solvent  in  pharmaceutical 
processing.  All  these  uses  of  EDC  as  intermediate  (more  than  99%  of  the  total  volume)  are 
outside the scope of authorisation, and can therefore result in exposure of workers. 

the  production  of  ethylenediamines, 

intermediate 

in 

According  to  registration  information,  the  total  amount  of  EDC  manufactured  in  the  EU  is 
between 1,000,000 –10,000,000 t/y. Another 10,000 – 50,000 t/y are imported into the EU. 

There are at least 18 producers and importers in the EU making more than 10 million tonnes per 
annum.  Less  than  3,000  workers  are  potentially  exposed  in  Europe  (2009  data),  most  in  the 
manufacture of VCM and about 500 exposed when 1,2-dichloroethane is used as a solvent in the 
pharmaceutical  industry.  The  number  of  workers  exposed  outside  of  VCM  manufacturing  is 

74  The  date  after  which  the  substance  cannot  any  longer  be  placed  on  the  market  or  used  by  any  manufacturer, 

importer or downstream user, unless an authorisation has been granted. 

38 

 
  
                                                 
small  and  the  amounts  of  1,2-dichloroethane  used  are  also  small,  and  it  is  likely  to  be  well 
controlled as well. 

The  IOM  Study  reports  2,264  workers  exposed  workers  in  EDC  and  vinyl  chloride  monomer 
(VCM)  manufacturing  facilities  in  the  EU.  An  estimated  11%  of  EDC  and/or  vinyl  chloride 
monomer  manufacturing  workers  would  be  exposed  above  4.1  mg/m3  (1  ppm)  8  TWA  and 
0.36% above an equivalent 20.5 mg/m3 (5 ppm.). 

Table 8. Ethylene dichloride (EDC) – Types of impacts 

Impact  Option 1: 

Option 2: 

Option 3:  

Option 4:  

Baseline 

Annex III entry 
8.2 mg/m3 
(2 ppm) 
Sk. 

Annex III entry 
4.1 mg/m3 

(1 ppm) 
Sk. 

Annex III entry 
20.5 mg/m3 
(5 ppm) 
Sk. 

Calculated 
decline in 
exposure of 9% 
per year. 

Additionally the 
substance is 
now subject to 
REACH 
authorisation. 

c
i
m
o
n
o
c
E

)
h
t
l
a
e
h
.
l
c
n
i
(

l
a
i
c
o
S

been 

Compliance  costs  have 
not 
directly 
calculated for this option 
but are assumed to lie in 
between 
for 
options 3 and 4. 

costs 

Compliance cost 
2010-2069:  

Compliance cost 2010-
2069:  

0-€43m (see text 
below for indication 
of costs per company) 

0-€13m. (see text below for 
indication of costs per 
company) 

As per 'General remarks' 
skin notations should not 
result in additional cost - 
should 
employers 
already 
the 
baseline  be  taking  steps 
risks 
to  manage 
to 
avoiding 
workers  by 
dermal exposure. 

under 

Impact  on  employment 
unlikely. 

As per 'General 
remarks' skin 
notations should not 
result in additional 
cost - employers 
should already under 
the baseline be taking 
steps to manage risks 
to workers by 
avoiding dermal 
exposure. 

Impact on 
employment unlikely. 

As per 'General remarks' 
skin notations should not 
result in additional cost - 
employers should already 
under the baseline be 
taking steps to manage 
risks to workers by 
avoiding dermal exposure. 

Impact on employment 
unlikely. 

No health impact 
quantification possible. 
Better use of personal 
protective equipment 
should have a positive 
health impact. 

Skin notations may be 
expected to improve 
awareness and 

No health impact 
quantification 
possible. Better use of 
personal protective 
equipment should 
have a positive health 
impact. 

Skin notations may be 
expected to improve 

No health impact 
quantification75 possible. 
Better use of personal 
protective equipment 
should have a positive 
health impact. 

Skin notations may be 
expected to improve 
awareness and 

75  See previous remarks on data unavailability. 

39 

 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Impact  Option 1: 

Option 2: 

Option 3:  

Option 4:  

Baseline 

Annex III entry 
8.2 mg/m3 
(2 ppm) 
Sk. 

enforceability. 

Annex III entry 
4.1 mg/m3 

(1 ppm) 
Sk. 

awareness and 
enforceability. 

Annex III entry 
20.5 mg/m3 
(5 ppm) 
Sk. 

enforceability. 

l
a
t
n
e
m

n
o
r
i
v
n
E

No significant 
impact 

No significant impact 

No significant impact  No significant impact 

Even if this substance is subject to REACH authorisation as of 22 November 2017, which will 
eventually phase out all non-essential uses, the impact of the introduction of an OEL on worker 
protection  should  not  be  underestimated.  Less  than  1%  of  the  total  production  volume  of  this 
substance will be subject to REACH authorisation, and occupational exposure might still occur 
in the intermediate uses of the substance 

The IOM Study suggests existing production occurs in closed systems and is highly automated. 
It is estimated that 5-10 enterprises could be affected by the introduction of an EU-wide OEL of 
1ppm and possibly fewer to an OEL of 5ppm, based on the assumption of 12 producers of EDC 
in the EU and 30-40 enterprises producing VCM. These enterprises are medium to large firms.  

Additional costs under all three options may refer to better use of personal protective equipment 
(PPE): €1-2k annually per company. Some companies might need more significant upgrades of 
their  exposure  controls  (at  36-183€k  annually  per  company)  but  given  the  size  of  those 
companies the costs are not considered disproportionally high. The risk of company closures is 
likely to be small, nor significant impact on competitiveness is expected. 

The  ACSH  recognises  that  option  2  may  be  challenging  for  some  activities,  especially  in  the 
case  of  multipurpose  facilities  using  the  substance  in  batch  processes  not  operating 
continuously. The Employers Interest Group (EIG) and subsequent related industry association 
positions  noted  difficulty  in  finding  additional  technical  improvements  as  a  result  of 
optimisation  of  plant  and  procedures  already  undertaken.    The  ACSH  therefore  noted  that 
'additional  time  may  be  requested  for  implementing  the  OEL  at  2  ppm'.  It  may  be  further 
concluded  that  compliance  with  option  3,  which  is  more  stringent,  may  not  be  technically 
feasible.  However, neither the opinion of EIG nor subsequent industry positions provided any 
quantified  data  which  could  indicate  costs  higher  than  those  identified  in  the  IOM  study.  
Aggregated compliance costs are the highest for option 3. While option 4 (5ppm) comes at the 
lowest  cost,  option  2  (2  ppm)  represents  the  most  appropriate  balance  between  worker 
protection and feasibility for industry. 

Table 9. Ethylene dichloride (EDC) – Comparison of options 

Criteria 

Option 1: 

Option 2: 

Option 3:  

Option 4:  

Baseline 

Annex III entry 
8.2 mg/m3 
(2 ppm) 
Sk. 

Annex III entry 
4.1 mg/m3 

(1 ppm) 
Sk. 

Annex III entry  
20.5 mg/m3 
(5 ppm) 
Sk. 

Effectiveness 

0 

≈/+ (increased 

≈/+ (increased 

≈/+ (increased 

40 

 
 
 
 
Efficiency 

Coherence 

protection but size 
unquantifiable) 

protection but size 
unquantifiable) 

protection but size 
unquantifiable) 

≈ (modest compliance 
costs) 

- (more 
significant 
controls upgrade 
needed) 

≈ (modest 
compliance costs) 

+ 

+ 

+ 

0 

0 

Scientific advice 
(SCOEL) 

EDC is categorised as a genotoxic carcinogen into the SCOEL carcinogen 
Group A (non-threshold). A 'skin' notation is recommended.  

(Draft final 
Recommendation, 
under public 
consultation, due 
for adoption Dec 
2016) 76 

With  regard  to  the  cancer  risk  estimates,  SCOEL  came  to  the  following 
estimates: 

  Cancer risk estimate with an excess lifetime cancer risk of 10-1 = 38.6 

ppm (158660 μg/m³)  

  Cancer risk estimate with an excess lifetime cancer risk of 10-3 = 0.386 

ppm (1586.6 μg/m3)  

  Cancer risk estimate with excess lifetime cancer risk of 10-4 = 0.0386 

ppm (158.66 μg/m3)  

  Cancer  risk  estimate  with  excess  lifetime  cancer  risk  of  10-5  = 

0.00386 ppm (15.866 μg/m3)  

ACSH 

An 8h TWA of 2 ppm is proposed.  

The  existing  duties  in  CMD  to  eliminate  or  otherwise  minimise  exposure  to  carcinogens 
wherever technically possible, ensure that employers are expected in any case to take whatever 
measures  are  technically  feasible  to  protect  workers  from  EDC.  Taking  this  into  account,  in 
combination with the analysis set out above, the option indicated in the overall ACSH opinion 
(OEL of 2 ppm) is appropriate. 

Introduction  of  an  OEL  with  a  skin  notation  as  recommended  by  SCOEL  could  entail  some 
health benefits (though quantification of those is not possible) and would ensure legal protection 
for  workers  and  clarity  for  enforcers  and  economic  operators.  Option  2  is  therefore  the 
preferred option. 

Industry remarks regarding feasibility, while unquantified and not substantiated, are taken into 
account  –  in  particular  the  ACSH  note  regarding  the  possibility  of  a  request  for  additional 
transitional measures. 

Impact on Member States, competitiveness, and proportionality 

In the case of EDC, 23 Member States will need to introduce (5) or update (18) their OEL to 
bring it down to 2 ppm (see annexes 7 and 10), therefore it is expected that a large proportion of 
exposed workers could benefit from improved legal protection.   
Non-EU countries have established a wide range of exposure values, from 4 to 40 mg/m3.  The 
retained option is within this range (8.2 mg/m3) and only China (7 mg/m3) and Canada-Quebec 
(4  mg/m3)  have  established  lower  OELs.  As  indicated  above  no  significant  impact  on 
competitiveness is expected. 

76  Draft Recommendation from the Scientific Committee on Occupational Exposure Limits for 1,2-dichloroethane 

(ethylene dichloride), SCOEL/SUM/302, 2016. 

41 

 
 
                                                 
5.5  4,4'-Methylenedianiline (MDA) 

is  mostly 

(99%)  used  as  an 

the  production  of  4,4'-
MDA 
methylenediphenyldiisocyante  (MDI),  which  is  used  in  the  production  of  polyurethane  foams. 
MDI  is  also  used  as  an  intermediate  in  processing  of  4-4'  methylenebis(cyclohexaneamine). 
Authorisation does not apply for MDA for 'intermediate' use, and therefore the use of MDA for 
the  production  of  MDI  and  4-4'  methylenebis(cyclohexaneamine)  is  outside  scope  of  REACH 
authorisation. 

intermediate 

in 

MDA has been subject to REACH authorisation since 21 August 2014 for the non-intermediate 
use,  for  example,  as  a  hardener  in  epoxy  resins  and  adhesives.  However,  no  applications  for 
authorisation have been received. For the purpose of analysis it can be assumed that all use of 
MDA which is in scope of REACH authorisation has ceased, and any new use would be subject 
to  effective  worker  protection  which  would  be  duly  considered  by  the  Risk  Assessment 
Committee  of  the  European  Chemicals  Agency  (ECHA)  and  the  European  Commission. 
However, this will not have any impact on the estimated number of workers exposed since the 
production  for  non-intermediate  uses  constitutes  a  negligible  share  of  the  total  production  in 
chemical industry. 

It  is  estimated  that  approximately  70-140  people  are  exposed  to  airborne  MDA  in  chemical 
industry77.  The  exposures  of  workers  results  either  from  process-generated  or  by-product  use 
release. 

The number of people affected by dermal exposure during intermediate uses in other industries 
than the  chemical  industry  that are  using  MDA  is  considerably  higher.  According  to the  IOM 
Study the estimates on the number of workers having dermal exposure to MDA were uncertain 
and  were  expected  to  be  in  the  range  between  390,000  and  3.9  million  workers78.  Around 
60,000-617,000 companies were estimated to employ workers having dermal exposure to MDA. 

Figure 4. Sector structure 

77  Mostly in the UK, NL, BE, IT, DE, ES, FI, DK, PT, AT, PL, SL and SK 
78  All  Member  States  have  industry  sectors  where  IOM  considered  dermal  exposure  to  MDA  likely.    It  may  be 
noted  that  in  recent  communication  the  industry  association  the  European  Diisocyanate  and  Polyol  Producers 
Association (ISOPA) have indicated that current EU use sectors are fewer than those identified in the IOM Study 
–  this  assessment  has  been  amended  to  reflect  this  reduced  range  of  sectors  affected,  but  as  updated  and 
substantiated employment figures in affected sectors have not been provided the assessment in the IOM Study 
has been retained. 

42 

 
 
                                                 
Table 10. MDA – Types of impacts 

Impact  Option 1: 

Option 2:  

Baseline 

Annex III entry 
0.08 mg/m3 
Sk. 

Option 4: 

Annex III entry 
0.8 mg/m3 
Sk. 

c
i
m
o
n
o
c
E

)
h
t
l
a
e
h

.
(

l
a
i
c
o
S

Exposure levels in 2010 
expected to decrease by 
7% based on historical 
changes in exposure levels 
- for inhalation route, not 
the dermal uptake. 

While the inhalation OEL is 
not expected to result in any 
significant costs, skin notation 
and the related compliance 
with best practices to reduce 
skin exposure expected to cost 
€1,000-2,000 per year per 
enterprise. Impact on 
employment unlikely. 

While the inhalation OEL is not 
expected to result in any 
significant costs, skin notation 
and the related compliance with 
best practices to reduce skin 
exposure expected to cost 
€1,000-2,000 per year per 
enterprise. 

Impact on employment 
unlikely. 

No health impact 
quantification possible. 

No health impact 
quantification possible. Better 
practices to reduce skin 
exposure are expected to have 
a positive impact on health. 

No health impact quantification 
possible79. Better practices to 
reduce skin exposure are 
expected to have a positive 
impact on health. 

Skin notations may be 
expected to improve 
awareness and enforceability. 

Skin notations may be expected 
to improve awareness and 
enforceability. 

79  Please see earlier remarks on the lack of data. 

43 

 
 
 
 
 
 
 
 
 
 
                                                 
Impact  Option 1: 

Option 2:  

Baseline 

Annex III entry 
0.08 mg/m3 
Sk. 

Option 4: 

Annex III entry 
0.8 mg/m3 
Sk. 

No significant impact 

No significant impact 

No significant impact 

l
a
t
n
e
m

n
o
r
i
v
n
E

Regarding  airborne  MDA,  the  IOM  Study  estimated  exposure  levels  in  2010  as  at  most  0.14 
mg/m3 during manufacture and 0.07mg/m3 in other industrial sectors. Introduction of an OEL at 
0.08 mg/m3 or 0.8 mg/m3 is not expected to result in significant costs for companies. 

There is little data on the levels of dermal exposure, but IOM considered it likely that exposures 
in manufacture sector were low, but could be higher in construction. Due to insufficient data no 
health  effects  and  monetary  benefits  could  be  estimated  for  dermal  exposure  reduction. 
However, options 2 and 4 should lead to health benefits (v-à-v the baseline) as a result of more 
significant reduction of dermal exposure to MDA.  

Table 11. MDA – Comparison of options 
Criteria 

Option 1: 

Baseline 

Effectiveness 

Efficiency 

Coherence 

Scientific advice 
(SCOEL)  
(Adopted 2012)80 

Option 2:  

Option 4: 

Annex III entry 
0.08 mg/m3 
Sk. 

Annex III entry 
0.8 mg/m3 
Sk. 

+ (significant dermal 
exposure reduction) 

+ (significant dermal 
exposure reduction) 

≈ (modest compliance 
costs) 

≈ (modest compliance 
costs) 

+ 

+ 

0 

0 

0 

MDA is categorised as a genotoxic carcinogen into the SCOEL carcinogen 
Group A.  

A skin notation is recommended 

A Biological Value of 1 ug/l urine is recommended. 

SCOEL  came  to  the  conclusion  that  it  is  not  feasible  to  derive  a 
health-based  8-hrs-TWA  limit  value  because  it  is  a  non-threshold 
carcinogen.  

SCOEL did not derive an exposure-risk relationship, however, in its 
recommendation it refers to a 2010 risk assessment performed by 
the German BAuA for the substance, which came to the conclusion 
that  a  value  of  0,073  mg/m3  represents  an  "acceptable  risk" 
according to the BAuA terminology 

80  SCOEL/SUM/107, March 2012 

44 

 
 
 
 
 
                                                 
ACSH 

0.08 mg/m3 and skin notation 

In  the  case  of  MDA,  in-depth  discussions  between  the  representatives  of  workers,  employers 
and  governments  in  the  ACSH  resulted  in  agreement  that  the  proposed  OEL  as  in  option  2 
represents  an  appropriate  risk  management  measure.  No  concerns  about  technical  feasibility, 
overall  costs  or  impact  on  competitiveness  outside  the  EU  have  been  raised  by  employers' 
representatives or governments' representatives. 

The impact assessment confirms that the option supported by the ACSH opinion (OEL of 0.08 
mg/m3)  is  appropriate.  Introduction  of  an  OEL  with  a  skin  notation  could  entail  some  health 
benefits  (though  quantification  of  those  is  not  possible)  and  would  ensure  legal  protection  for 
workers and enhanced clarity for enforcers and economic operators. Option 2 is therefore the 
preferred option. 

Impact on Member States, competitiveness, and proportionality 

In the case of MDA, 23 Member States will have to introduce (12) or update (11) their OEL to 
bring it down to 0.08 mg/m3 (see Annex 7 and 10). 82 % of exposed workers are estimated to 
work  in  those  23  Member  States  (Croatia  not  included)  and  would  consequently  benefit  from 
improved  legal  protection  thanks  to  the  introduction  of  the  OEL.  Introducing  an  OEL  would 
also ensure that lack of an OEL or a less stringent OEL does not act as an incentive for business 
in decisions concerning the plant location. 

The introduction of a skin notation in Annex III  would facilitate compliance and enforcement of 
the  existing  CMD  obligation  to  –  so  far  as  technically  possible  –  eliminate  or  otherwise 
minimise exposure to these classified carcinogens, and would therefore be justified. 

OELs  in  the  non-EU  countries  considered  are  equal  to  or  higher  (up  to  10  times)  than  the 
retained option. As indicated above no significant impact on competitiveness is expected.  

5.6  Trichloroethylene (TCE) 

Trichloroethylene  (TCE)  has  been  classified  as  a  group  2A  carcinogen  by  IARC  and  as  a 
Category  1B  carcinogen  in  the  EU  under  CLP.  Exposure  to  TCE  is  associated  with  increased 
risks of kidney, liver and biliary cancers and non-Hodgkin’s Lymphoma (NHL). Exposures to 
high  concentrations  may  also  cause  headaches,  lung  irritation,  dizziness,  or  nerve,  kidney  and 
liver damage in the long-term. 

TCE  is  mainly  used  in  intermediate  applications  as  well  as  in  the  metal  cleaning  and  in  the 
adhesives  industry.  Consumer  use  is  not  permitted.  According  to  REACH  registration 
information available on ECHA's website, trichloroethylene is manufactured and/or imported in 
the  European  Economic  Area  in  10,000  to  100,000  tonnes/year81.  It  is  estimated  that 
approximately  74,000  workers 
the  EU  are 
potentially exposed to TCE. 

in 

The use of TCE is regulated by the solvent emissions 
directive (SED)82 which requires, where more than 1 
tonne of any solvent(s) (including TCE) are used per 
year) an emission limit equivalent to less than 5 ppm 
must  be  complied  with.  It  is  therefore  assumed  that 
in-scope firms have already taken measures to reduce 

81 Source: European Chemicals Agency 

https://echa.europa.eu/substance-information/-

/substanceinfo/100.001.062, latest update 15/01/2016 

82  Council Directive 1999/13/EC of 11 March 1999 on the limitation of emissions of volatile organic compounds 

due to the use of organic solvents in certain activities and installations 

45 

 
 
                                                 
emissions (of all solvents including TCE) below the SED limits. These measures include putting 
in place closed systems for metal degreasing, as well as substitution for surface cleaning. 

TCE  has  also  been  added  to  Annex  XIV  to  REACH  and  is  therefore  subject  to  REACH 
authorisation, as a result of which any use outside the terms of a case-by-case authorisation (or a 
valid pending application) is not permitted from 21 April 2016. 

For  the  purpose  of  analysis  it  is  therefore  assumed  that  all  use  of  TCE  which  is  in  scope  of 
REACH authorisation is subject to effective worker protection which has been duly considered 
by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) and the 
European Commission. 

'Intermediate' use and exposures of workers resulting from process-generated substances are not 
in scope of REACH authorisation. Approximately 75% of the total TCE production, as assessed 
in  the  IOM  Study,  was  used  in  intermediate  applications.  TCE  is  also  used  in  the  metal 
degreasing  and  adhesives  industries.  TCE  use  as  a  solvent  has  been  declining  and  in  2007 
solvent use accounted for approximately 25% of TCE production in the EU. The decreasing use 
trends  are  a  result  of  stringent  requirements  under  the  Solvents  Emissions  Directive  (SED), 
REACH  and  a  voluntary  industry  commitment  through  the  European  Chlorinated  Solvent 
Association (ESCA).83 

This has driven companies to use TCE for surface cleaning only in closed systems, as well as to 
look  for  solvent  substitution  when  possible.  For  metal  degreasing,  it  is  estimated  that  the 
introduction of automated closed systems and solvent substitution has resulted in the estimated 
exposure dropping to below 10 ppm.84 

In 2011 there were two companies in the EU manufacturing TCE, while other companies act as 
suppliers. Total TCE production in Europe reduced by more than 50% between 1985 and 2007, 
and is likely to have reduced further due to a manufacturing plant closing in 2009. 
There are approximately 140,00085 firms engaged in the 'treatment and coating of metals'. Since 
TCE  is  an  effective  solvent  for  the  cleaning  of  metals,  it  may  be  assumed  that  all  of  the 
enterprises would seek to use it under appropriate economic and safe use conditions.  

Italy,  Germany,  Poland,  UK  and  France  gather  together  more  than  60%  of  all  firms.  Spain, 
Czech  Republic,  Sweden,  Portugal  and  Hungary  each  have  more  than  4,000  firms  accounting 
for more than 20% of the total. The structure of the metal degreasing sector is not well known. 
In  the  case  of  the  UK,  the  sector  comprises  a  large  number  of  small  companies,  with  a  high 
proportion having fewer than 20 workers. 

Sectors  where  TCE  is  subject  to  non-intermediate  use,  such  as  metal  degreasing,  would  not, 
however,  be  affected  significantly  by  the  introduction  of  an  OEL  because  TCE  has  been 
included into REACH authorisation which – coupled with the SED – should result in effectively 
controlled exposures. 

Note on STEL value 

TCE is the only substance for which a STEL is considered in this initiative.   A more detailed 
account of general STEL policy considerations is given in Annex 4 at section 11.2.2. 

83  See: http://www.chlorinated-solvents.eu/index.php/regulatory-compliance/tri-charter   
84  Source:  IOM  Research  Project  P937/3,  May  2011  –  Health,  social-economic  and  environmental  aspects  of 
possible  amendments  to  the  EU  Directive  on  the  protection  of  workers  from  the  risks  related  to  exposure  to 
carcinogens 
Trichloroethylene 
at 
https://echa.europa.eu/documents/10162/13640/svhc_axvrep_france_cmr_trichloroethylene_en.pdf  

mutagens 

work 

and 

– 

85  2006 Eurostat data 

46 

 
                                                 
It is possible to have peak short term exposures which would not bring the 8hr average above an 
OEL,  but  which  might  themselves  be  harmful.    STEL  values  are  therefore  necessary  where 
exposure  patters  are  not  addressed  by  8hr  TWA  values  alone,  and  short  term  exposures  can 
result in adverse health effects. 

In relation to the calculation of compliance costs, it should be noted that compliance with an 8-
hr  TWA  OEL  already  requires  that  necessary  equipment,  sampling  strategy,  and  other  risk 
management  measures  be  in  place  at  enterprise  level,  and  that  STEL  values  –  which  are 
normally significantly higher – should therefore already be complied with where an 8-hr TWA 
values  are  established.  Therefore,  STEL  values  do  not  generate  any  additional  costs  for 
companies. 

The  risk  management  and  monitoring  approaches  will  be  the  same  as  both  values  are  for 
inhalation  –  the STEL provides an important additional workplace monitoring  value to  ensure 
short-term or 'excursion' exposures remain below harmful levels. 

Of  the  22  Member  States  which  have  already  a  national  OEL  for  TCE  in  place  (regardless 
whether  they  are  higher,  equal  to,  or  lower  than  the  retained  option),  16  have  also  adopted  a 
STEL.  (One Member State, IE, has only a STEL and no OEL.)  It can therefore be seen that the 
approach  of  combining  an  8-hr  TWA  and  STEL  OELs  is  supported  by  the  majority  of  the 
Member States  –  indeed 8-hr  TWA  and STEL values,  along with  notations,  should always be 
seen as a complementary and mutually dependent package of occupational hygiene inputs. 

Table 12. Trichloroethylene – Types of impacts 

Impact  Option 1: 

Option 2: 

Option 4: 

Baseline 

Annex III entry 
54.7 mg/m3 (10ppm) 8hr TWA 
164.1 mg/m3 (30 ppm) STEL 
Sk. 

Annex III entry 
273.5 mg/m3 (50 ppm) 8hr TWA 
164.1 mg/m3 (30 ppm) STEL 
Sk. 

Investment is expected to occur 
already under the baseline, only 
possibly later in time: the costs of 
anticipating this expenditure by 10-
20 years would be in the range of 
€22-37m (TWA and STEL values 
combined).  

As per 'General remarks' skin 
notations should not result in 
additional cost - employers should 
already under the baseline be taking 
steps to manage risks to workers by 
avoiding dermal exposure. 

No major macroeconomic 
impacts are expected. 

c
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Exposure levels are 
estimated to decline 
by 7% annually up to 
2030, and then to 
remain constant. 

Given the 
requirements of the 
SED and of the 
voluntary industry 
agreement (ECSA), 
any firm using TCE 
above 1 tonne per 
year should already 
have closed systems 
in place. 

Closed systems 
manufacturers 
should benefit from 
increased demand 
over time. 

Investment is expected to occur 
already under the baseline, only 
possibly later in time: the costs of 
anticipating this expenditure by 
10-20 years would be in the range 
of €154-257m. The annualised 
cost of compliance is estimated at 
6.000€ per firm affected by the 
OEL (TWA and STEL values 
combined). 

There is insufficient data to 
estimate the number of firms that 
would require closed systems in 
order to meet an OEL of 54.7 
mg/m3 (10ppm). 

As per 'General remarks' skin 
notations should not result in 
additional cost - employers should 
already under the baseline be taking 
steps to manage risks to workers by 
avoiding dermal exposure. 

No major macroeconomic 

47 

 
 
 
Impact  Option 1: 

Option 2: 

Option 4: 

Baseline 

Annex III entry 
54.7 mg/m3 (10ppm) 8hr TWA 
164.1 mg/m3 (30 ppm) STEL 
Sk. 

Annex III entry 
273.5 mg/m3 (50 ppm) 8hr TWA 
164.1 mg/m3 (30 ppm) STEL 
Sk. 

impacts are expected. 

Total attributable deaths for 2010-
2069: 2 900 (390 less) 

The health cost savings relative to 
the baseline are estimated to be 
between €118-430m over this 
period. 

YYLs to decrease, from 481 years to 
112 years for liver cancer, 189 years 
to 162 years for kidney cancer, and 
196 years to 54 years for NHL. 

Skin notations may be expected to 
improve awareness and 
enforceability. 

Total attributable 
deaths for 2010-2069: 
3 290 

Health costs over the 
period 2010-69 are 
estimated to be 
between €1,582m to 
€5,657m. 

YYLs to decrease 
over the period, from 
481 years to 243 
years for liver cancer, 
189 years to 174 
years for kidney 
cancer, and 196 years 
to 98 years for NHL. 

Total attributable deaths for 2010-
2069: 3 430 (this figure suggests 
more cancers than under the 
baseline; however this is due to the 
modelling used by the IOM study, 
that assumed a 99% compliance to 
the OEL rather than a 100% 
compliance). 

There is not expected to be a 
reduction in health costs relative to 
the baseline scenario. 

YYLs to decrease, from 481 years to 
288 years for liver cancer, 189 years 
to 178 years for kidney cancer, and 
196 years to 137 years for NHL. 
This is a worse prediction than under 
the baseline. 

Skin notations may be expected to 
improve awareness and 
enforceability. 

No significant impact  No significant impact 

No significant impact 

)
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Specifically for TCE, exposure prevalence estimates in the IOM study were based on the 2007 
Finnish CAREX, the 2004 Spanish CAREX and the 2000-2003 Italian CAREX. The proportion 
of exposed workers in each industry was taken from each of these three CAREX estimates and 
the  average  proportion  exposed  across  all  three  countries  calculated  for  each  industry. 
According to the Finnish Job-Exposure Matrix, the average exposure for all occupational groups 
is estimated to be 5 ppm. 

Introduction  of  an  OEL  would  entail  some  costs  for  business  (higher  in  the  case  of  option  2) 
even though also for companies not covered by the SED it is assumed that the requirements of 
national  OELs,  the  ECSA  Charter  and  REACH  authorisation  have  led  firms  to  already  put  in 
place closed systems, or to substitute TCE. Companies which have not yet made the investments 
to  protect  workers  either  through  closed  systems  or  substitution,  will  need  to  do  so  with  the 
introduction of the OEL of 10 ppm. Among those companies, SMEs could be more vulnerable 
to the capital cost of a closed system. If as a consequence they decide to close down, there could 
be  some  limited  effects  on  employment  in  IT,  DE,  PL  and  the  UK  in  particular.  It  is  very 
unlikely, however, that the costs of compliance would be large enough collectively to cause any 
significant  macroeconomic  impacts.  It  is  also  possible  that  some  firms  will  substitute 
trichloroethylene or use an alternative process for metal degreasing. Therefore, there may only 

48 

 
 
 
 
 
 
be  a  small  redistribution  of  goods  and  services  bought  rather  than  any  significant  change  in 
overall gross output. 

There are expected to be more significant health benefits of introducing an OEL at 10ppm (54.7 
mg/m3),  which  is  also  the  SCOEL  recommended  level,  than  at  50  ppm  due  to  the  additional 
reduction in exposure and a decrease in attributable deaths, and the potential for CMD OELs to 
be used as exposure benchmarks for decision making in other areas. 

Table 13. Trichloroethylene– Comparison of options 
Criteria 

Option 1: 

Option 2: 

Baseline 

Annex III entry 
54.7 mg/m3 (10 ppm) 8hr 
TWA 
164.1 mg/m3 (30 ppm) 
STEL 
Sk. 

Option 4: 

Annex III entry 
273.5 mg/m3 (50 ppm) 8hr 
TWA 
164.1 mg/m3 (30 ppm) 
STEL 
Sk. 

Effectiveness 

Efficiency 

0 

0 

+ (significant decrease in 
number of deaths) 

≈ (protection not much 
improved) 

- (additional costs 
proportionate to benefits but 
potential risk for SMEs) 

- (small compliance costs but 
for no significant additional 
benefits) 

Coherence 

Scientific advice 
(SCOEL)  
(Adopted 2009)86 

ACSH 

+ 

0 
An 8 hr TWA of 54.7 mg/m3 (10 ppm), a STEL of 164.1 mg/m3 (30 ppm), 
a skin notation, and a biological monitoring value of 20 mg trichloroacetic 
acid/l. urine is recommended. 

+ 

An 8hr TWA of 54.7 mg/m3 (10 ppm) is proposed. 

In the case of TCE, in-depth discussions between the representatives of workers, employers and 
governments  in  the  ACSH  resulted  in  full  consensus  that  the  proposed  OEL  as  in  option  2 
represents  an  appropriate  risk  management  measure.  No  concerns  about  technical  feasibility, 
overall  costs  or  impact  on  competitiveness  outside  the  EU  have  been  raised  by  employers' 
representatives or governments' representatives. 

The  impact  assessment  confirms  that  the  option  supported  by  the  ACSH  opinion  (OEL  of  10 
ppm) is appropriate. Introduction of this OEL with a STEL, and a skin notation as recommended 
by  SCOEL  would  result  in  higher  health  benefits  than  the  other  considered  options,  would 
ensure legal protection for workers and enhanced clarity for enforcers and economic operators. 
Option 2 is therefore the preferred option. 

Impact on Member States, competitiveness, and proportionality 

In the case of trichloroethylene 17 Member States will have to introduce (6) or update (11) their 
OEL  to  bring  it  down  to  54.7  mg/m3  (10  ppm)  (annex  7  and  10).  Nearly  74%  of  exposed 
workers are estimated to work in those 17 MSs (see table 4 of Annex 7) and would consequently 
benefit  from  improved  legal  protection  thanks  to  the  introduction  of  the  OEL.  Introducing  an 
OEL would also ensure that lack of an OEL or a less stringent OEL does not act as an incentive 
for business in decisions concerning the plant location. 

86  SCOEL/SUM/142, April 2009 

49 

 
 
                                                 
The retained option is equivalent (Australia, Ontario) or more stringent than the values in non-
EU  jurisdictions  where  these  have  been  identified,  except  in  the  only  case  of  China  where  a 
lower limit value of 30 mg/m3 is established.   

5.7  Complex  polycyclic  aromatic  hydrocarbon  (PAH)  mixtures  with  benzo[a]pyrene  as 

an indicator 

Polycyclic aromatic hydrocarbons (PAHs) are a large class of organic compounds – more than 
100 single PAHs identified, including benzo[a]pyrene. 

Benzo[a]pyrene  and  complex  PAH  mixtures  are  not  produced  and  used  as  such,  but  are 
ubiquitously  formed  during  combustion  (burning)  and  pyrolysis  of  organic  materials  –  as  a 
result they do not exist in isolation but as components of complex mixtures that contain many 
different PAH and related compounds. 

The  largest  single  source  of  PAHs  is  the  burning  of  wood  in  homes.  Automobile  and  truck 
emissions are also major sources of PAH. Environmental tobacco smoke, unvented radiant and 
convective kerosene space heaters, and gas cooking and heating appliances may be significant 
sources  of  PAH  in  indoor  air  and  potentially  occupational  exposure.  Important  human  (non-
occupational)  sources  of  individual  exposure  to  PAH  are  inhalation  of  tobacco  smoke  and 
contaminated air and ingestion of the compounds in foodstuffs. 
Occupational exposure, 87 

The  most  extensively  studied  individual  PAH  is  benzo[a]pyrene  (BAP)  –  which  is  one  of  the 
strongest genotoxic carcinogens, and which significantly contributes to the carcinogenic potency 
of  PAH-rich  mixtures.  Benzo[a]pyrene  as  a  pure  chemical  is  not  of  occupational  relevance. 
However, it is commonly used as a quantitative indicator compound within complex mixtures of 
PAHs,  which  are  ubiquitously  formed  during  combustion  and  pyrolysis  processes  of  organic 
materials, like the processing and use of coal and coal-derived products88. 
According  to  the  most  recent  SCOEL  recommendation  40489  and  the  information  provided  in 
the  IARC  monograph  Number  92,  the  'production  and  use  of  coal  tar  and  coal  tar-derived 
products are major sources of occupational exposure to PAHs.' 

This risk to workers is already reflected by entry number 2 of Annex I to the CMD: '2. Work 
involving exposure to polycyclic hydrocarbons present in coal soot, coal tar or coal pitch.', and 
are therefore under the scope of the Directive. 
Benzo[a]pyrene as well as seven other PAHs subject to REACH restrictions90 are classified as 
carcinogens, category 1B in the CLP Regulation91, and are therefore as well under the scope of 
the Directive92. 

87  IARC  Monograph  Volume  92,  2010:  Some  Non-heterocyclic  Polycyclic  Aromatic  Hydrocarbons  and  Some 

Related Exposures 

88  Crude coal tar is usually distilled, and blends of distillation fractions are used for various purposes, such as wood 
conservation, paints, road tars and roofing materials. PAH  concentrations in coal-tar products may range from 
less than 1% up to 70% or more. 
89  SCOEL  Recommendation  404  on  Polycyclic  Aromatic  Hydrocarbon  mixtures  containing  benzo[a]pyrene, 

adopted December 2016 

90  entry  50  of  Annex  XVII  of  to  REACH  Regulation  contain  next  to  benzo[a]pyrene  the  following  PAHs: 
benzo[e]pyrene  (CAS  No  192-97-2),  benz[a]anthracene  (CAS  No  56-55-3),  chrysene  (CAS  No  218-01-9), 
benz[e]acephenanthrylene, benzo[b]fluoranthene (CAS No 205-99-2), benzo[j]fluoranthene (CAS No 205-82-3), 
benzo[k]fluoranthene (CAS No 207-08-9), and dibenzo[a,h]anthracene (CAS No 53-70-3) 

91  PAHs  have  been  linked  to  skin,  lung,  bladder,  liver  and  stomach  cancer  in  well-established  animal  studies. 

Exposure to PAHs has also been linked with cardiovascular disease and poor fetal development 

50 

 
 
                                                 
Benzo[a]pyrene was examined in the IOM Study, where the impact of introducing an OEL of 
0,002 mg/m3 for benzo[a]pyrene was evaluated.  IOM concluded that in 2006 234,000 workers 
were exposed to high (0.001 – 0.01 mg/m3 or higher), and 7 millions of workers to low, levels 
(0.000001 – 0.001 mg/m3) of benzo[a]pyrene. 

National  occupational  exposure  limit  values  for  benzo[a]pyrene  (see  Annex  7)  range  from 
0,00015  mg/m3  to  0,01  mg/m3.  However,  these  are  sometimes  specific  to  different  types  of 
workplace (e.g. to underground mining)93, or refer to benzo[a]pyrene as a marker of total PAH 
concentration (DE). 

Table 14. Complex PAH mixtures with benzo[a]pyrene as an indicator – Types of impacts 

Impact  Option 1: 

Option 2:  

Baseline 

Annex III entry 
Sk. 

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A decrease rate of 6% 
per annum for at least 
next 20 years is 
assumed. 

Same as baseline. 

As per 'General remarks' skin 
notations should not result in 
additional cost - employers should 
already under the baseline be 
taking steps to manage risks to 
workers by avoiding dermal 
exposure. 

No impact on employment. 

Option 3:  

Annex III entry 
0.002 mg/m3 
Sk. 

No macroeconomic effects 
foreseen as the current exposure 
concentration is already below the 
suggested threshold in all MS. The 
vast majority of investment 
required by industry to comply 
with this OEL already occurred. 

As per 'General remarks' skin 
notations should not result in 
additional cost - employers should 
already under the baseline be 
taking steps to manage risks to 
workers by avoiding dermal 
exposure. 

No impact on employment. 

Same as baseline. 

Same as baseline. 

Skin notations may be expected to 
improve awareness and 
enforceability. Significant benefit 
of establishing a skin notation 
expected as a result of the dermal 
exposure hazard. 

Skin notations may be expected to 
improve awareness and 
enforceability. Significant benefit 
of establishing a skin notation 
expected as a result of the dermal 
exposure hazard. 

)
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Health cost range, in 
the period 2010-2069, 
is €6.2bn-194bn (€45-
453m for NMSC only) 
mostly due to previous 
exposure. 

Total attributable 
deaths: 47 bladder, 430 
lung, and 2 NMSC in 
2010, respectively 
declining to three, to 
five, and rising to 
three. 

YLL decrease from 
544 to 13 per year for 

92  This  applies  as  well  to  any  mixture  containing  benzo[a]pyrene  or  other  PAHs  classified  as  a  carcinogen, 

category 1B, in a concentration at or above their generic or specific concentration limit 

93  e.g.  in  Austria,  a  value  of  0,005  mg/m3  is  applicable  to  "Cokeries,  oven  area",  and  a  value  of  0,002  mg/m3 
applies to "other workplaces"; in Slovenia and Slovakia a value of 0,005 mg/m3 is applicable to "Coking", and a 
value of 0,002 mg/m3 applies to "others" 

51 

 
 
 
 
 
                                                                                                                                                            
Impact  Option 1: 

Option 2:  

Baseline 

Annex III entry 
Sk. 

Option 3:  

Annex III entry 
0.002 mg/m3 
Sk. 

bladder and from 6,689 
to 61 per year for lung 
cancer. YLL increase 
from 24 to 29 for 
NMSC.94 

DALY decrease from 
703 to 17 per year for 
bladder and from 6,978 
to 64 per year for lung 
cancer. DALY increase 
from 24 to 29 for 
NMSC. 

No significant impact  No significant impact 

No significant impact 

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As  in  the  case  of  all  other  considered  chemical  agents,  the  exposure  trends  for  PAHs  used  to 
establish  the  baseline  are  quoted  from  the  IOM  study.  The  validity  of  these  assumptions  is 
discussed in the introduction to section 5 of the first wave IA. 

Option 2 consists of a skin notation in Annex III, linked to the current Annex I entry. While it is 
assumed that monetised costs/benefits would closely match the baseline, the added value lies in 
very useful information for health professionals and employers. 

Option  3  links  an  exposure  limit  value  in  Annex  III  to  the  current  Annex  I  entry.  The  IOM 
Study  concluded  that  exposures  in  the  EU  were  already  well  below  0.002  mg/m3  and  no 
significant  health  benefits  or  costs  or  social  or  macro-economic  costs  should  result  from 
introducing  an  OEL  at  that  value.    SCOEL  is  of  the  opinion  that  safe  health-based  exposure 
limits  cannot  be  derived95.  ACSH  also  considered  that  health  benefit  of  setting  an  OEL  is 
insufficient  to  justify  action.  Introduction  of  such  an  OEL  could  also  result  in  practical 
difficulties  -  in  recent  communication  the  industry  association  of  the  European  Plastics 
Converters (EuPC) have indicated that a limit of 0.002 mg/m3 'would be difficult to measure… 
currently no air measurements are available.' 

Table 15. Complex PAH mixtures with benzo[a]pyrene as an indicator – Comparison of options 

Criteria 

Option 1: 

Baseline 

Option 2:  

Annex III entry 
Sk. 

Option 3:  

Annex III entry 
0.002 mg/m3 
Sk. 

94 There are no YLDs for NMSC as the majority are dealt with easily and do not incur any lasting disability. 
95  SCOEL  Recommendation  404  on  Polycyclic  Aromatic  Hydrocarbon  mixtures  containing  benzo[a]pyrene, 

adopted December 2016 

52 

 
 
 
  
 
                                                 
Effectiveness 

Efficiency 

Coherence 

Scientific advice 
(SCOEL)  

(Draft final 
Recommendatio
n, under public 
consultation, 
due for adoption 
Dec 2016)96 

0 

0 

0 

≈ (moderately reinforcing 
existing protection) 

≈ (exposure already 
below OEL) 

≈ (no significant 
costs/benefits) 

+ 

≈ (no significant 
costs/benefits) 

+ 

In  a  recommendation  on  PAH  mixtures  containing  benzo[a]pyrene' 
currently  undergoing  public  consultation,  SCOEL  concluded  that  'PAH 
mixtures  containing  benzo[a]pyrene,  PAH  mixtures  and  benzo[a]pyrene 
are genotoxic carcinogens (SCOEL Group A) for which safe health-based 
exposure  limits  cannot  be  derived.'  As  a  consequence,  no  health-based 
OEL was recommended. 

SCOEL proposes 0.5 µg 1-hydroxypyrene per g creatinine as a biological 
monitoring value with sampling advice. 

A skin notation is warranted. 

ACSH 

There  is  insufficient  added  health  benefit  in  the  proposed  OEL  of  0.002 
mg/m3 8 hrs TWA [for benzo[a]pyrene].  

Workers  Interest  Group:  In  view  of  the  risk-based  values  derived  in  the 
Netherlands  and  in  Germany  of  0.00055  mg/m³  and  0.0007  mg/m³, 
respectively,  any  proposed  binding  limit  value  should  not  exceed  those 
values.  Given  the  high  number  of  workers  exposed  to  benzo[a]pyrene, 
such a value should be derived within less than three years 

In  the  case  of  this  substance,  in-depth  discussions  between  the  representatives  of  workers, 
employers and governments in the ACSH resulted in agreement that at this stage no OEL should 
be  proposed,  as  in  option  2.  However,  ACSH  agreed  that  an  OEL  for  PAHs  is  important  and 
work should be carried out to evaluate the scientific aspects with the view to proposing as OEL 
at  some  time  in  the  future.  Workers'  representatives  emphasised  the  need  for  an  OEL  in  the 
future. 

The impact assessment supports the course of action proposed by the ACSH opinion (no OEL) 
and confirms that introduction of a skin notation in Annex III would provide useful information 
for choosing adequate risk management measures. Option 2 is therefore the preferred option. 

Even  if  the  current  Annex  I  entry  covers  major  sources  of  occupational  exposure  to  PAHs 
(including BAP), it is unclear which other occupational exposure situations exist during which 
workers  are  exposed  to  these  substances  and  their  mixtures.  The  need  for  a  revision  of  the 
current Annex I entry should therefore be evaluated in the future. 

Impact on Member States, competitiveness, and proportionality 

Action  taken  at  the  European  Union  level  by  introducing  a  skin  notation  in  Annex  III  would 
facilitate compliance and enforcement of the existing CMD obligation to – so far as technically 
possible – eliminate or otherwise minimise exposure to these classified carcinogens, and would 
therefore be justified. It would in no way affect industry competitiveness. 

96  Draft SCOEL Recommendation 404 on Polycyclic Aromatic Hydrocarbon mixtures containing benzo[a]pyrene 

53 

 
 
 
                                                 
5.8  Mineral Oils as Used Engine Oils 

Oils that have been used before in internal combustion engines to lubricate and cool the moving 
parts  within  the  engine  ("mineral  oils  as  used  engine  oils")  consist  of  blends  of  hydrocarbons 
including  paraffins,  naphthenics,  and  complex/alkylated  polyaromatics  and 
lubricating 
additives. Engine oils are used in internal combustion engines, which power cars, motorcycles, 
diesel trains, ships, lawn mowers and other machinery. Occupational exposure is via the dermal 
route  –  skin  contact  during  changing  of  oil  or  working  with  engine  parts.  Recycling  of  non-
metal  scrap  is  another  source  of  exposure,  although  relatively  less  important.  Inhalation 
exposure to mineral oils as used engine oils is unlikely. 

The composition of engine oils, and hence of mineral oils as used engine oils, has been changing 
over time to meet the requirements of newer engine designs and performance requirements. The 
composition of engine oils also varies depending on the needs of different engines and operating 
conditions,  and  changes  during  use  with  the  accumulation  of  fuel  components,  water,  metals, 
metal oxides, and combustion products (including PAHs) within the oil.97 

Exposure  to  mineral  oils  as  used  engine  oils  may  cause  skin  cancer.  Because  'mineral  oils  as 
used  engine  oils'  are  process-generated  –  and  not  'supplied'  as  such  –  they  are  not  subject  to 
classification according to CLP. 

Mineral  Oils  as  Used  Engine  Oils  have  been  thoroughly  described  and  assessed  by  IARC  in 
1984.  IARC  concluded  that  there  was  sufficient  evidence  from  studies  in  humans  that  used 
mineral  oils,  containing  various  additives  and  impurities,  used  in  several  occupations,  were 
carcinogenic  in  humans.  The  final  IARC  evaluation  does  not  explicitly  mention  'used  engine 
oils',  but  concludes  that  'Mineral  oils,  mildly  treated  or  untreated'  are  carcinogenic  to  humans 
under IARC Group 1.98 In the Opinion of SCOEL, "mineral oils as used engine oils" defined to 
mean "oils that have been used before in internal combustion engines to lubricate and cool the 
moving  parts  within  the  engine"  are  carcinogenic  in  SCOEL  Group  A,  for  which  no  health-
based exposure threshold can be derived. SCOEL strongly recommends a skin notation. 

The number of workers exposed is estimated at 1 million, employed mostly in maintenance and 
repair  of  motor  vehicles  (0.9  million).  Other  sectors  include  sales,  maintenance  and  repair  of 
motorcycles  (less  than  0.1  million)  and  recycling  of  non-metal  waste  and  scrap  (less  than  0.1 
million).  Around  370,000  companies  are  working  in  these  sectors  and  a  majority  of  these 
companies are SMEs.  

Mineral Oils as Used Engine Oils (UEOs) are 
not  'supplied'  per  se  and  hence  not  classified 
according  to  the  CLP  Regulation.    It  may  be 
noted  that  polycyclic  aromatic  hydrocarbon 
(PAH)  substances,  including  benzo[a]pyrene 
and  others,  are  among  the  most  important 
carcinogenic components of UEOs.  The most 
harmful types of PAH are classified according 
to  CLP  –  in  the  case  of  benzo[a]pyrene  this 
classification  includes  the  potential  to  cause 
an allergic skin reaction. Labelling provisions 

97  PAHs  are  ubiquitously  formed  during  the  incomplete  combustion  and  pyrolysis  of  organic  materials.  PAHs 
generally, and their presence in mineral oils as used engine oil, are treated separately in sections xx and xx of 
this Impact Assessment Report. 

98  It  should  be  noted  that  these  oils  occur  early  in  the  refining  process;  they  are  dermal  carcinogens  due  to  the 
PAHs present, which originate from the crude oil source material. As such, they are not used to make lubricating 
oils in the EU. 

54 

 
                                                 
will not, however, apply where they are present in process-generated form.  Employers should 
be  aware  of  the  dermal  hazard  –  again,  in  the  case  of  PAHs  present  in  Mineral  Oils  as  Used 
Engine Oils (which are process-generated) a skin notation adds value by raising awareness. 

Table 16. Mineral Oils as Used Engine Oils – Types of impacts 

Impact 

Option 1: 

Baseline 

Option 2:  

Annex I entry  
Annex III entry 
Sk. 

€46m-918m 

Cost per company and per year are expected 
to be very low (€100-500). 

No decline in exposure 
levels assumed, but the 
number of workers 
affected will increase due 
to expected increases in 
employment and ageing 
population. 

Total attributable deaths 
for 2010-2069: 1180 

Total attributable deaths 2010-2069: 880 less 
than under baseline 

Monetised values: €0.5-
2.8 bn  

Total attributable cases: 90,000 less than 
under baseline. 

Total attributable cases: 
128,850 

YYL: 10 880 

Monetised savings: €0.3-1.6 bn related to 
avoidance of health costs associated with 
future exposure 

No significant impact 

No significant impact 

c
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E

)
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(

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S

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m

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v
n
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The estimates of the prevalence of exposure to mineral oils as used engine oils in the EU were 
not  available.  Instead,  the  number  of  affected  workers  was  estimated.  It  was  assumed  that  the 
workers  exposed  are  employed  in  the  three  sectors  mentioned  above  and  belong  to  the 
occupational groups most likely to have direct skin contact with mineral oils as used engine oils 
(technicians,  service  workers,  elementary  occupations  and  others).  No  European  data  was 
available for cancer numbers, therefore data from Great Britain was used also for other countries 
in proportion to the age and sex structure of their population. 

A range of best practice can be used to limit dermal exposures. These include use of gloves or 
barrier creams, removal and cleaning of contaminated clothing, avoiding keeping contaminated 
rags in the pockets, etc. Under the baseline it was assumed that the share of exposed workers in 
enterprises which do not comply with the best practices lies within the interval of 10% (0.1 m) 
and 40% (0.4 m). 

The  estimated  deaths  increase  over  the  period  from  7  in  2010  to  36  per  annum  in  2060  and 
afterwards.  Likewise,  the  estimated  annual  attributable  cancer  registrations  are  set  to  increase 
from 916 in 2010 to 3,554 in 2060. The forecasted increases are due to forecasted doubling of 
the people employed in the sectors at risk of exposure. Also, the ageing population plays a role 
in increasing the prevalence of skin cancer. 

55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Option 2 follows the ACSH Opinion that an Annex I entry in CMD, identifying mineral oils as 
used engine oils as carcinogenic for the purposes of the CMD and also indicating that concern 
relates to the dermal route of exposure, is appropriate. It is complemented with a skin notation 
as strongly recommended by SCOEL.  

Option 2 further promotes the aforementioned best practices, establishing a clear legal basis to 
the requirement of using best practice to reduce dermal exposure, increasing awareness among 
employers  and  workers,  and  improve  the  ability  to  enforce  the  requirement.  The  costs  up  to 
2030/40 are not expected to differ significantly from the baseline scenario due to past exposure. 
However,  full  compliance  with  good  practice  could  avoid  the  health  costs  post-2040.  The 
monetized value of these health benefits is in the range of €0.3-1.6bn. 

The maintenance and repair of vehicles is relevant to all Member States with no country having 
a  particularly  high  exposure.  Full  compliance  with  best  practices  entails  costs  for  businesses, 
which  include  costs  of  familiarisation  with  requirements,  investment  in  equipment,  and  time 
spent on cleaning, training, and administration. It is estimated that 20,000 to 80,000 enterprises 
will be affected and the compliance costs per enterprise are relatively low, at around €100-500 
per year, and these costs are likely to be an overestimate since the current compliance is likely 
above  60%.  This  amounts  to  €2m-39m  per  year  and  €46m-918m  over  the  period  2010-2070. 
The  high  total  costs  reflect  the  high  number  of  businesses  and  workers  affected.  The  cost  of 
compliance  per  enterprise  in  order  to  reduce  skin  exposure  is  between  €  100  and  €  500  per 
company per year. Thus, it is not considered to be prohibitive for any enterprise size. 

There should not be any negative impact the competitiveness of the concerned firms. The total 
costs are negligible compared to the value creation in the manufacturing sector (€ 5 trillion in 
2006 alone). With fewer life years lost and fewer cancer registrations, there should be a benefit 
to the economy through avoided loss of output and consumption in the future (post 2040).The 
high  number  of  small  companies  indicates  a  competitive  market,  thus  additional  costs  should 
hardly be shifted on the consumer. Most likely, the act of changing their prices would cost the 
companies more than the additional costs due to protective measures in the short term. 

Concerning employment, there are no expectations for any noticeable changes to the numbers of 
workers  required  as  a  result  of  introducing  an  EU-wide  OEL.  However,  job  patterns  may  be 
altered  as  it  is  recognised  that,  in  order  to  meet  best  practice,  behavioural  change  amongst 
employees and updating health and safety training is expected to be required.  

Table 17. Mineral Oils as Used Engine Oils – Comparison of options 

Criteria 

Option 1: 

Baseline 

Effectiveness 

Efficiency 

0 

0 

Option 2:  

Annex I entry  

Annex III entry 
Sk. 

+ (significant protection increase) 

≈ (significant extra costs but proportionate v-à-v benefits) 

56 

 
 
 
 
 
 
 
 
 
 
Coherence 

0 

+ 

Scientific advice 
(SCOEL) (Adopted 
2016)99 

ACSH 

Carcinogenic Group A – Non-Threshold. Occupational exposure is via the 
dermal route – a skin notation is strongly recommended. 

An Annex I entry should refer to mineral oils as used engine oils, and specify 
that the entry covers oils that have been used before in internal combustion 
engines to lubricate and cool the moving parts within the engine.  

ACSH did not explicitly recommended a skin notation but noted in its Opinion 
that the route of exposure of concern is skin. Therefore Option 2 is 
complemented with a skin notation as strongly recommended by the SCOEL. 

In the case of mineral oils as used engine oils, in-depth discussions between the representatives 
of  workers,  employers  and  governments  in  the  ACSH  resulted  in  full  consensus  that  the 
proposed Annex I entry as in option 2 represents an appropriate risk management measure. No 
concerns about technical feasibility, overall costs or impact on competitiveness outside the EU 
have been raised by employers' representatives or governments' representatives. 

The impact assessment confirms that the option supported by the ACSH opinion (Annex I entry) 
is appropriate, and also identifies additional benefit from amending Annex III.  Likewise, a skin 
notation in Annex III appears appropriate. Option 2 is therefore the preferred option. 

Impact on Member States, competitiveness, and proportionality 

Identification of Mineral Oils as Used Engine Oils as carcinogenic is not possible under the CLP 
Regulation, and national practices vary considerably as regards identifying mineral oils as used 
engine oils as carcinogenic and setting relevant OELs. Under these conditions a minimum basis 
of  protection  against  the  risks  arising  from  workers'  exposure  to  these  carcinogens  cannot  be 
ensured  for  all  EU  workers  –  it  follows  that  an  action  taken  at  the  European  Union  level,  to 
clarify that mineral oils as used engine oils are carcinogenic and in scope of the CMD provisions 
and to introduce a skin notation in Annex III, and hence that exposure to it should be eliminated 
or otherwise minimised as far as technically possible, would be justified. 

5.9  Summary of the retained options 

It  has  been  shown  in  the  previous  sections  that  the  considered  chemical  agents  vary 
significantly. The table below summarises the retained options on the basis of several criteria. 
Where available evidence presented in this assessment is in a range covering several criteria, the 
midpoint is used to avoid ambiguity. 

i) Stakeholders' acceptance 

For all the twelve impact assessed carcinogens, the assessment validates as the retained option 
for seven carcinogens the position expressed in opinion of the tripartite ACSH, plus additional 
factors  important  for  worker  protection.  However,  for  a  few  there  have  been  some  dissenting 
opinions in the course of the discussions. The following rating is applied: 

- XX - full support in the ACSH; 

- X - partial or conditional support in the ACSH. 

99  SCOEL/OPIN/405, June 2016 

57 

 
 
 
 
                                                 
It should be noted that in case of partial or conditional support by the stakeholders represented 
in  the  ACSH,  diverging  views  concerned  e.g.  ranges  of  values  or  feasibility  considerations 
rather than the principle of setting an OEL at EU level. 

ii) Legal clarity 

The changes considered for the seven carcinogens, will improve legal clarity for employers and 
workers.  In  the  case  of  process-generated  substances,  where  identification  in  Annex  I  is 
proposed this is expected to improve legal clarity in every Member State. In the case of OELs, 
the number of MS needing to introduce or amend national OELs corresponding to the proposed 
EU value is used to gauge improvements in legal clarity. 

- XX - legal clarity will be improved in half or more of the MS 

- X - legal clarity will be improved in less than half of the MS 

 iii) Size of the problem 

The numbers of workers potentially exposed to the carcinogens vary substantially. While CMD 
amendments will be useful even if currently few workers are exposed (for example this might 
change in the future), an immediate impact will be greater when exposed populations are bigger. 

- XXX - over 500,000 exposed workers 

- XX - between 50,000 and 499,999 exposed workers 

- X - less than 50,000 exposed workers, and/or subject to REACH authorisation 

iv) Health benefit 

There is also a divergence in the size of monetised health benefits of introducing OELs. 

- XXX - benefits over 100 m EUR 

- XX - benefits between 10 m EUR and 100 m EUR 

- X - benefits of less than 10 m EUR, and/or subject to REACH authorisation 

v) Limited costs for business 

While all the retained options are expected to be feasible for business, there are different levels 
of associated costs for business. 

- XXX - costs below 10 m EUR, and/or subject to REACH authorisation 

- XX - costs between 10 and 100 m EUR 

- X - costs over 100 m EUR 

Table 18 

Name of the 
chemical agent 

Retained option 
(ppm – parts per m, mg/m3) 

s
r
e
d
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o
h
e
k
a
t
[option number]  S

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l
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S

t
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e
n
e
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t
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e
H

s
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s
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o
f

s
t
s
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t
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i

Epichlorohydrine 

Annex III entry 
1.9 mg/m3 
Sk. 

XX 

XX 

X 

X 

XXX 

[2] 

58 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ethylene dibromide 
(EDB) 

Ethylene dichloride 
(EDC) 

Annex III entry 
 0.8 mg/m3 
(0.1 ppm) 
Sk. 

Annex III entry 
 8.2 mg/m3 
(2 ppm) 
Sk. 

4,4'-
Methylenedianiline 
(MDA) 

Annex III entry 
0.08 mg/m3 
Sk. 

Trichloroethylene 
(TCE) 

Annex III entry 
8TWA 54.7 mg/m3 (10 ppm) 
STEL 164.1 mg/m3 (30 ppm) 
Sk. 

Complex PAH 
mixtures with 
benzo[a]pyrene as an 
indicator 
Used engine oils 

Annex III entry 
Sk. 

Annex I entry 

Annex III entry 
Sk. 

XX 

XX 

X 

X 

XX 

XX 

XX 

X 

X 

XX 

XX 

XX 

X 

X 

X 

XX 

XX 

XX 

XXX  X 

X 

XX 

XXX  X 

XXX 

XX 

XX 

XXX  XXX  X 

[2] 

[2] 

[2] 

[2] 

[2] 

[2] 

6  OVERALL IMPACT OF THE PACKAGE OF RETAINED OPTIONS 

6.1 

Impact on workers 

The retained options package (henceforth 'the retained option') should result in benefits in terms 
of avoided work-related cancer cases and related monetised health benefits. As mentioned in the 
introduction  to  section  5  assessing  health  benefits  of  action  against  carcinogenic  chemicals  is 
challenging  and  the  quantified  benefits  are  likely  underestimated.  The  greatest  assessable 
benefits are expected in relation to trichloroethylene and mineral oils as used engine oils. In the 
case of those two substances the retained option would result, until 2069, in: 

  Mineral Oils as Used Engine Oils: 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  

  Trichloroethylene: 390 saved lives and a monetised health benefit of €118-430m related to 

avoidance of health costs 

Impacts  of  action  for  other  chemicals  under  this  initiative  are  relatively  smaller  or  difficult  to 
assess. 

Further discussion can be found in the prior Impact Assessment (at p. 79) of expected benefits 
as regards reduced economic costs caused by disability and premature death, shielding workers 
and families from suffering financial and social costs which would otherwise occur in a baseline 
scenario. 

The study underlying the present assessment was limited to assessing health benefits resulting 
solely from avoided cancer cases. Nevertheless, the chemical agents under consideration pose a 
range of other occupational hazards including, for various carcinogens considered here: 

  suspicion of causing genetic defects 

59 

 
 
 
  damage to fertility 
  damage to an unborn child 
  damage to organs through prolonged or repeated exposure 
  irritation and/or damage to the eyes, skin, and/or respiratory system 
  allergic skin reaction 
  causing drowsiness or dizziness 

Enhanced workplace control of the considered carcinogens will also contribute to decreasing the 
risk associated with exposure to these occupational risks. The available data is not sufficient to 
estimate  the  magnitude  of  related  health  and  socio-economic  benefits.  However,  taking  into 
account  general  estimates  of  costs  related  to  these  diseases,  it  could  be  expected  that  benefits 
could be considerable. For example, according to a study on costs of occupational hand eczema, 
conducted in 2013 in Germany100 the annual direct and indirect costs per worker diagnosed and 
treated were on average €2,646 and €6,152 respectively. Also research conducted in Australia 
confirmed  that  occupational  skin  diseases  had  a  significant  socioeconomic  impact,  with  an 
estimated annual cost of over $33 m.101 

6.2 

Impact on businesses 

Detailed  discussion  can  be  found  in  the  prior  Impact  Assessment  (at  p.  80)  of  the  range  of 
economic impacts of occupational cancer on business and consumers. 

As  regards  costs  incurred  by  enterprises  for  risk  reduction  measures,  the  retained  option  will 
affect  operating  costs  for  companies  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.102 

For  the  majority  of  considered  carcinogens,  impacts  cannot  be  fully  quantified  based  on 
available  data  but  impacts  on  operating  costs  and  conduct  of  business  (including  small  and 
medium enterprises) are expected to be minimal as only small adjustments will need to be done 
in specific cases to ensure full compliance. The retained option will not impose any additional 
information obligations and will not lead to an increase in administrative burdens on enterprises. 

6.2.1 

Impact on SMEs 

The economic impacts for SMEs of changes to CMD – and in particular establishing OELs – are 
discussed in detail in the prior Impact Assessment (at p. 81). 

For a majority of chemical agents covered by this initiative, SMEs represent a large proportion 
of  the  relevant  industries.  Therefore,  SMEs  specificities,  their  limitations  and  particular 
challenges have been duly taken into account in the overall analysis presented in section 5. The 
analysis has shown that in most cases costs which will be incurred by SMEs are affordable for 
the  companies.  The  most  significant  costs  foreseen  in  the  IOM  study  associated  with  the 
considered carcinogens relate to investment in closed systems for use of TCE. Such investment 
is  likely  to  have  already  been  made  by  a  majority  of  companies,  following  the  requirements 
under  the  SED,  national  OELs,  the  ECSA  Charter  and  REACH.  Introduction  of  an  OEL  will 

100 Diepgen  TL,  Scheidt  R,  Weisshaar  E,  John  SM,  Hieke  K.  Cost  of  illness  from  occupational  hand  eczema  in 

Germany. Contact Dermat. 2013;69(2):99–106. [PubMed] 

101 http://www.safeworkaustralia.gov.au/sites/swa/media-events/media-releases/pages/mr16032012 
102 Including  estimated  costs  of  anticipating  investment  needed  to  comply  with  measures  reflected  in  retained 

option. 

60 

 
 
                                                 
only  make  a  significant  impact  on  companies  which  have  not  yet  made  the  investments  to 
protect workers either through closed systems or substitution. Among those companies, SMEs 
could be more vulnerable to the capital cost of a closed system. If as a consequence they decide 
to close down, there could be some limited effects on employment. However, it is also possible 
that  some  firms  will  substitute  trichloroethylene  or  use  an  alternative  process  for  metal 
degreasing.  

6.2.2 

Impact on competition and competitiveness 

The  impacts  of  changes  to  CMD  –  and  in  particular  establishing  OELs  –  on  competition  and 
competiveness are discussed in detail in the prior Impact Assessment (at p. 82). 

The retained option 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 and providing certainty re enforceable exposure limit across the EU. 

The retained option should not have a significant impact on the external competitiveness of EU 
firms.  On  the  one  hand,  the  detailed  assessment  provided  above  proves  that  in  most  cases 
additional  compliance  costs  per  firm  are  modest.  On  the  other,  while  non-EU  countries  have 
established  a  wide  range  of  exposure  values  that  vary  significantly  and  inconsistently  across 
jurisdictions  (see  Table  3  in  annex  7),  the  retained  exposure  values  are  not  out  of  line  with 
international  practice.  In  the  case  of  epichlorohydrine,  for  example,  the  retained  OEL  (1.9 
mg/m3) is similar to that in place in countries such as New Zealand and South Korea, although 
more stringent (China) and less stringent OELs (e.g. US, Switzerland, Singapore ) are applied in 
some other third countries. 

It should be noted, however, that OELs established in different jurisdictions cannot necessarily 
be  compared  like-for-like.  OEL  setting  methods  differ  substantially  across  jurisdictions  as  a 
result, for example, of different approaches to whether and how socioeconomic factors may be 
taken into account, differences in legal enforceability or expectations regarding compliance, use 
of  scientific  evidence  and  analytical  method,  industrial  relations  and  roles  played  by  industry, 
worker  representatives,  and  others.  As  a  result,  caution  should  be  exercised  in  making 
comparisons and drawing conclusions regarding values which may not be directly comparable. 

It can however be observed that, in most cases, the retained option fits 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. 

Combined with existing duties in CMD to eliminate or minimise exposure to a level as low as is 
technically possible, the retained option is not expected to significantly impact EU international 
competitiveness. 

6.3 

Impact on Member States/national authorities 

The cost impacts of changes to CMD – and in particular establishing OELs – on Member States 
and national authorities are discussed in the prior Impact Assessment (at p. 83). In summary, the 
retained  option  should  contribute,  although  not  significantly,  to  mitigate  financial  loss  of 
Member State social security systems.  

Additional  administrative  costs  and  enforcement  costs  might  be  incurred  by  enforcing 
authorities.  These  costs  are  not  quantifiable  as  the  granularity  of  Member  States'  reporting  of 
enforcement activity is not sufficient to distinguish costs related to a particular OEL. 

However,  it  is  not  expected  for  the  costs  to  be  significant.  OEL  enforcement  will  take  place 
according  to  normal  mechanisms  for  compliance  improvement  and  enforcement,  including 
informal conversations with employers as well as formal correspondence and legal enforcement 
action. This will normally be brigaded for any given employer with other OSH provisions (for 

61 

 
example  workplace  transport,  slips  and  trips,  machinery  safety,  stress)  rather  than  specific  to 
OELs.  Specific reporting would only be the case where Labour Inspectorates undertake targeted 
occupational  chemical  carcinogen  enforcement  activity  and  OEL  campaigns.  Costs  will 
therefore be generally affected by Labour Inspectorate resourcing, prioritisation and targeting – 
no  assumption  may  be  made  that  enforcement,  which  is  a  Member  State  competence,  will 
receive (or demand) greater resourcing and priority as a result of an OEL being set. 

At the same time, establishing OELs,  and other explicit references to a given carcinogen in the 
CMD  brings  clarity  regarding  legal  requirements,  and  so  facilitates  the  work  of  inspectors  by 
providing a helpful tool for compliance checks.  

Setting  OELs  at  EU  level  would  limit  the  need  for  national  administrations  to  conduct 
duplicating scientific analyses. 

6.4 

Impact on fundamental rights 

The  impact  on  fundamental  rights  is  considered  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). 

6.5  Subsidiarity and proportionality 

The protection of workers health against risks arising from exposure to carcinogens is already 
covered  by  EU  legislation,  in  particular  by  Directive  2004/37/EC  (CMD),  which  can  be 
amended at EU level after a two-stage consultation of the social partners. 

The  retained  option  takes  into  account  long  and  intensive  discussions  with  all  stakeholders 
(representatives from employees' associations, representatives from employers' associations, and 
representatives from governments), including consideration of socioeconomic feasibility. 

While  the  quantified  benefits  of  the  initiative  appear  modest,  it  should  be  recalled  that  the 
initiative  would  contribute  to  saving  some  1300  human  lives  in  the  forthcoming  50  years  and 
that  these  figures  based  on  the  estimations  made  the  IOM  study,  are  likely  to  be  significant 
underestimates as discussed in chapter 5.There is a range of additional benefits which could not 
be quantified for the reasons already explained. 

Further, it may be noted that, according to a 2016 report by the Netherlands National Institute 
for Public Health and the Environment (RIVM)103 three carcinogens addressed by the retained 
option - benzo[a]pyrene (addressed as a PAH indicator), mineral oils (addressed as used engine 
oil)  and  MDA  are  among  the  top  10  carcinogenic  substances  to  which  the  largest  numbers  of 
workers  are  currently  exposed;  another  4  from  that  list  of  10  carcinogens  were  in  the  prior 
proposal – hardwood dust, hydrazine, respirable crystalline silica and chromium VI compounds. 

The report also mentions an EU OSHA survey in 2008 in which nine out of 20 Member States 
mentioned  difficulties  in  the  process  of  deriving  OELS  for  carcinogenic  and  mutagenic 
substances, and indicates that, despite projected declining exposure levels, 'forecast impacts will 
probably not be lower than those of 2012' (p. 36). The RIVM report concludes that 'developing 
OELs for carcinogens at the EU level will contribute to the overall protection of the workforce 
in the EU' (p. 17). 

103 Work-related  cancer 

in 

the  European  Union 

:  Size, 

impact  and  options  for  further  prevention, 

http://rivm.nl/en/Documents_and_publications/Scientific/Reports/2016/mei/Work_related_cancer_in_the_Europ
ean_Union_Size_impact_and_options_for_further_prevention, p. 11 

62 

 
 
 
                                                 
The  subsidiarity  and  proportionality  check  done  for  each  specific  agent,  indicated  that,  where 
relevant data was available, introduction of proposed OELs would improve legal protection for 
an estimated 69% to 82% of exposed workers (see Table 4 in annex 7). 

In addition, the proposal does not set levels to be directly translated into national legislation but 
maximum limits. Member States can decide to introduce lower levels. 

As per the prior Impact Assessment, the planned action therefore complies with the principles of 
proportionality and subsidiarity. 

6.6  Budgetary implications 

There are no budgetary implications for the EU budget and no additional costs will arise for the 
agency EU-OSHA. 

7  HOW WOULD ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

7.1  Monitoring arrangements  

The table below presents the core indicators for each operational objective and the data sources 
for the monitoring of the core indicators. 

Table 19 

Operational 
objective 

and 

The reduction of 
occupational 
diseases 
occupational 
cancer 
related 
cases 
the 
in 
European Union  

Indicators  

Monitoring 
monitoring indicators  

arrangements/data 

sources 

for 

The  number  of 
occupational 
diseases 
occupational 
related 
cases in the EU 

cancer 

and 

The data sources for the monitoring of this indicator are: 

-  data  that  could  be  collected  by  Eurostat  on  occupational 
diseases  if  the  results  of  the  on-going  feasibility  study  are 
positive, as well as on and other work-related health problems 
and  illnesses  in  accordance  with  Regulation  (EC)  No 
1338/2008.104 

-data  notified  by  employers  to  the  competent  national 
authorities  on  cases  of  cancer  identified  in  accordance  with 
national  law  and/or  practice  as  resulting  from  occupational 
exposure to a carcinogen or mutagen in accordance with Art. 
14 (8) of Directive 2004/37/EC, and which  may be  accessed 
by the Commission in accordance with Article 18 of Directive 
2004/37/EC;  

-data submitted by Member States in the national reports on 
the implementation of EU OSH acquis, submitted in 
accordance with Art. 17a of Directive 89/391/EEC 

The reduction of 
costs  related  to 
occupational 
cancer 
economic 
and 
operators 
for 
social 
security  systems 

for 

The costs related to 
occupational 
cancer 
for 
economic operators 
of 
(e.g. 
loss 
and 
productivity) 
security 
social 
the 
in 
systems 

The monitoring of this indicator will require the comparison 
of the expected figures on the burden of occupational cancer 
in terms of economic loss and health care costs and the 
collected figures on these matters after the adoption of the 
revision. The productivity loss and health care costs can be 
established on the basis of the data on the number of 
occupational cancer cases and the number of occupational 
cancer deaths (the arrangements for the collection of the data 

104 Regulation (EC) No 1338/2008 on Community statistics on public health and health and safety at work, OJ L 

354/70, 31.12.2008. 

63 

 
 
 
                                                 
in  the  European 
Union 

European Union. 

on occupational cancer cases are described supra in this 
table).  

A two-stage compliance assessment (transposition and conformity checks) will be carried out by 
the  Commission  for  the  transposition  of  the  limit  values.  The  monitoring  of  application  and 
enforcement  will  be  undertaken  by  national  authorities,  in  particular  the  national  labour 
inspectorates.  At  EU  level,  the  Committee  of  Senior  Labour  Inspectors  ('SLIC')  informs  the 
Commission regarding problems relating to the enforcement of Directive 2004/37/EC. 

While  collection  of  reliable  data  in  this  area  is  complex,  the  Commission  and  EU-OSHA  are 
actively  working  on  improving  data  quality  and  availability  so  that  the  actual  impacts  of  the 
proposed initiative could be measured in a more accurate way and additional indicators could be 
developed  in  the  future  (e.g.  in  relation  to  mortality  caused  by  occupational  cancer).  Ongoing 
projects  include  cooperation  with  national  authorities  on  the  European  Occupational  Diseases 
Statistics (EODS) data collection, a Commission-funded project to establish by the end of 2016 
a first version of a database on occupational exposure for some hazardous  chemicals and EU-
OSHA's assessment of the feasibility of a survey on exposure to carcinogens.  

7.2  Evaluation arrangements  

In  accordance  with  Art.  17a  of  Directive  89/391/EEC,  every  five  years,  Member  States  are 
required to submit a report to the Commission on the practical implementation of the EU OSH 
Directives, including Directive 2004/37/EC. 

Using  these  reports  as  a  basis,  the  Commission  is  required  to  evaluate  the  implementation  of 
Directive  2004/37/EC  and,  to  inform  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Advisory Committee on Safety and Health at Work of 
the results of this evaluation and, if necessary, of any initiatives to improve the operation of the 
regulatory framework. 

Given  the  data  challenges  explained  earlier,  it  is  suggested  to  made  use  of  the  next  ex-post 
evaluation  exercise  (2012-2017)  to  define  the  baseline  values  (benchmark)  that  will  allow 
assessing  the  effectiveness  of  the  planned  CMD  revision.  Evaluation  of  the  practical 
implementation  of  the  proposed  amendments  could  possibly  be  based on  the  following  period 
(2017-2022). 

64 

 
 
 
 
 
8  ANNEX 1 – PROCEDURAL INFORMATION 

Annexes 

Concerning the process to prepare the impact assessment report and the related initiative. 

8.1 

Lead DG 

Lead  DG:  Directorate-General  Employment,  Social  Affairs  and  Inclusion,  Unit  B/3  Health, 
Safety and Hygiene at Work 

8.2 

Consultation of the Regulatory Scrutiny Board (RSB)  

The Impact Assessment report was reviewed by the RSB and discussed with the author DG in a 
meeting  on  26  October  2016.  On  28  October  2016  the  RSB  issued  a  positive  opinion  with 
reservations.  

The revisions introduced in response to the RSB reservations are summarised in the table below: 

RSB main reservations  
and 
(1)  Set  out 
underpinning evidence. Elaborate on decision 
to  refrain  from  setting  OELs  for  four 
substances, including diesel engine exhaust.  

sequence  of 

steps 

Changes done to the IA 
the  procedure  of 
More  detailed  description  of 
amending  OEL,  the  roles  of  SCOEL,  social  partners 
and  the  ACSH  as  well  as  of  the  approach  adapted  in 
the  IA  to  verifying  options  proposed  by  the  ACSH  - 
see the new section 2.3. 

Description  of  criteria  taken  into  consideration  when 
not  proposing  further  action  on  some  substances. 
those  actions  have  not  been 
Clarification 
'discarded'  but  rather  'withheld'.  -  see  section  2.3. 
('Step 5 - Impact Assessment) and the new section 4.2. 

that 

(2)  EU  added  value  of  OELs.  Explain  the 
level of ambition. 

(3)  Elaborate  on  the  interface  between  CMD 
and REACH. 

in 

to 

the 

text  referring 

the  four 
Amendments 
substances  in  section  4.2.,  in  particular  diesel  engine 
exhaust,  to  further  explain  why  action  is  withheld  at 
this  stage.  Concerning  diesel  engine  exhaust  the  new 
text also clarifies that a sectoral social partners action 
would be considered complimentary rather than as an 
alternative to a legislative action. 
Further  elements  have  been  added  in  Section  2.2.  to 
explain EU added value of the initiative. 

The level of ambition is considered in the description 
of the procedure in section 2.3. 

A  new  discarded  option  consisting  of  directly 
adopting  the  most  stringent  national  OELs  has  been 
explained in section 4.3. 

Section 3.2.2. provides a more thorough description of 
the interface - and complementarity - of REACH and 
OSH, including a practical example of where workers 
would not be protected from exposure to carcinogens 
covered by REACH. The section refers to the REFIT 
platform opinion and follow-up actions planned by the 
Commission services. 

65 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 (4)  Amend  or 
to 
biomonitoring  to  ensure  consistency  with 
eventual proposal. 

references 

remove 

(5) Technical comments 

Since  biological  monitoring  values  cannot,  for  legal 
reasons, be part of this initiative, references to options 
including  such  values  have  been  removed  across  the 
introduces  biological 
document.  A  new  4.1.2. 
monitoring  values  as 
important  complementary 
measures. 

The  document  has  been  revised  to  take  into  account 
other comments made by the RSB, most notably: 

- the problem definition has been amended to cover all 
12 substances in sections 1-3. 

-  section  5.1  and  a  new  section  5.1.1.  give  further 
the  methodological  challenges, 
explanation  of 
including 
timeline  and 
long 
difficulties  in  providing  more  information  on  future 
evolution in exposures. 

the  reasons  for  a 

- further explanation re costs of setting a STEL value 
for an OEL (see 5.1.2. and 5.6). 

-  costs  related  to  skin  notations  have  been  more 
clearly  presented  in  the  relevant  substance-specific 
parts of section 5). 

information  on 

-  substance-specific  sections  have  been  amended  to 
add 
impacts  on  employment, 
competitiveness,  and  to  clarify  further  impacts  on 
SMEs.  Where  available,  the  breakdown  per  company 
size  has  been  added  to  give  a  better  overview  of  the 
relevant industry structure. Revisions have been made 
in  particular  concerning  TCE,  UEO  and  PAH  to 
address specific comments of the RSB. 

-  a  brief  description  of  differences  between  OEL 
setting  methods  across  jurisdictions  has  been  in 
section 6.2.2.). 

-  further  information  on  enforcement  costs  has  been 
added in section 6.3. 

-  in  section  7.1.  efforts  to  improve  availability  and 
reliability of data have been described. 

8.3 

Evidence used in the impact assessment 

8.3.1 

IARC Monographs 

Various IARC Monograph have been used as evidence in preparation of the impact assessment. 
The  exact  source  of  which  monograph  has  been  used  for  each  individual  chemical  agents  is 
provided for in Annex 5 of this document. 

Through the Monographs programme, IARC seeks to identify the causes of human cancer. The 
criteria  established  in  1971  to  evaluate  carcinogenic  risks  to  humans  were  adopted  by  the 

66 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Working Groups whose deliberations resulted in the first 16 volumes of the Monographs series. 
Those  criteria  were  subsequently  updated  by  further  Ad-hoc  Advisory  Groups  (IARC  1977, 
1978, 1979, 1982, 1983, 1987, 1988, 1991, 1992, 2005, 2006). 

As stated in the preamble of the Monographs, 'the objective of the programme is to prepare, with 
the help of International Working Groups of experts, and to publish in the form of Monographs, 
critical  reviews  and  evaluations  of  evidence  on  the  carcinogenicity  of  a  wide  range  of  human 
exposures.  The  Monographs  represent  the  first  step  in  carcinogen  risk  assessment,  which 
involves examination of all relevant information in order to assess the strength of the available 
evidence  that  an  agent  could  alter  the  age-specific  incidence  of  cancer  in  humans.  The 
Monographs may also indicate where additional research efforts are needed, specifically when 
data immediately relevant to an evaluation are not available'.105 

The  scope  of  the  programme  nowadays  now  include  specific  chemicals,  groups  of  related 
chemicals, complex mixtures, occupational or environmental exposures, cultural or behavioural 
practices, biological organisms and physical agents. 

For  further  information  on  for  example  the  selection  of  agents,  the  data  used  for  the 
Monographs, the selection of experts, the working procedures etc. can all be found in detail in 
the preamble of the monographs (see above reference). 

8.4 

External expertise  

8.4.1  Use of scientific expertise / Commission expert groups / SCOEL 

The Scientific Committee on Occupational Exposure Limits for Chemical Agents was set up by 
Commission Decision 95/320/EC106 to evaluate the health effects of chemical agents on workers 
at work. The work of the Committee directly supports Union regulatory activity in the field of 
occupational safety and health, when available. It develops high quality comparative analytical 
knowledge  and  it  ensures  that  Commission  proposals,  decisions  and  policy  relating  to  the 
protection of workers’ health and safety are based on sound scientific evidence. 

The Committee assists the Commission, in particular, in evaluating the latest available scientific 
data and in proposing occupational exposure limits for the protection of workers from chemical 
risks, to be set at Union level pursuant to Council Directive 98/24/EC and Directive 2004/37/EC 
of the European Parliament and of the Council. 

Members of SCOEL are highly qualified, specialized, independent experts selected on the basis 
of objective criteria. They are appointed in their personal capacity and provide the Commission 
with  Recommendations  and  Opinions  that  are  helpful  for  the  development  of  EU  policy  on 
workers protection. 

For  the  purpose  of  this  initiative,  the  Commission  services  have  used  the  relevant  chemical 
agent-related  SCOEL  recommendation.  The  exact  reference  for  the  recommendation  used  for 
each individual chemical agent is provided in the relevant tables and footnotes in section 6 of 
this document. 

8.4.2  Studies performed by external consultants 

Study on health, socio-economic and environmental aspects of possible amendments to the EU 
Directive  on  the  protection  of  workers  from  the  risks  related  to  exposure  to  carcinogens  and 
mutagens at work 

105 http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf  
106 Commission Decision 95/320/EC of 12 July 1995 setting up a Scientific Committee for Occupational Exposure 

Limits to Chemical Agents (OJ L 188, 9.8.1995, p. 14)  

67 

 
                                                 
Following  the  two  stage  consultation  of  the  European  social  partners  (see  section  9.1  of  this 
document), Commission published on 25 July 2008 an open call for tender in order to carry out 
an assessment of the social, economic and environmental impacts of a number of policy options 
concerning  the  protection  of  workers  health  from  risks  arising  from  possible  exposure  to 
carcinogenic chemical agents at the workplace. 

The main outputs were a study report containing full reports on 25 carcinogenic chemical agents 
and two other policy issues relating to the effectiveness of risk management measures and risk 
based criteria for the setting of occupational exposure limit values. 

The contract started on 24 April 2009 and ran until 27 April 2011. 

The  outcome  of  this  study  (summary  report  and  individual  chemical  agents'  reports)  provides 
the main basis for this Staff Working Document and are summarised in the relevant sections of 
this document. The executive summary report, the summary report as well as the reports for the 
individual chemical agents are available on the internet107. 

8.4.3  Study on chemical agents toxic to reproduction 

Commission published on 22 May 2010 an open call for tender in order analyse at EU-level the 
socioeconomic and environmental impact in connection with possible amendment to Directive 
2004/37/EC  to  extend  the  scope  to  chemical  agents  toxic  to  reproduction,  category  1A  or  1B 
according to the CLP Regulation. 

The underlying consideration was that under the REACH Regulation these chemical agents may 
be  considered  as  substances  of  very  high  concern  (SVHC),  and  they  should  therefore  also  be 
subject to the more stringent protective and preventive measures under the CMD, in particular 
with regard to the substitution provision. 

However, the more stringent preventive and protective measures established for carcinogens and 
mutagens under the CMD are mainly related to the fact that for those substances health based 
OELs cannot be derived. However, for the majority of reprotoxic substances, this is, based on 
the current scientific knowledge, the case. As a consequence, it can be argued that the protection 
of  workers  against  exposure  to  these  substances  is  already  covered  under  the  CAD,  and  that 
Indicative OELVs or OELs for these chemical agents should be established under that Directive. 

Nevertheless,  and  following  in  particular  the  request  from  the  workers  interest  group  of  the 
ACSH  (see  also  information  provided  in  annex  2  of  this  document  –  Social  Partner 
Consultation), the study was launched in order to complement the available data to enable the 
Commission to take an informed decision. 

The  contract  started  on  30  November  2010  and  the  final  report  was  submitted  to  the 
Commission in February 2013. 

The results of the study did not provide sufficient evidence that including these chemical agents 
under  the  scope  of  the  CMD  would  lead  to  a  higher  protection  of  workers.  This  option  was 
therefore not further considered for this initiative. 

107 The following links are only provided for those chemical agents subject to the 2nd amendment of the CMD: 
- Summary report: http://ec.europa.eu/social/BlobServlet?docId=10149& 
- Epichlorohydrine: http://ec.europa.eu/social/BlobServlet?docId=10177&langId=en 
- EDB: http://ec.europa.eu/social/BlobServlet?docId=10171&langId=en 
- EDC: http://ec.europa.eu/social/BlobServlet?docId=10170&langId=en 
- MDA: http://ec.europa.eu/social/BlobServlet?docId=10162&langId=en 
- TCE: http://ec.europa.eu/social/BlobServlet?docId=10156&langId=en 
- Benzo(a)pyrene: http://ec.europa.eu/social/BlobServlet?docId=10182&langId=en 
- Mineral Oils as Used Engine Oils: http://ec.europa.eu/social/BlobServlet?docId=10174&langId=en 

68 

 
                                                 
9  ANNEX 2 - STAKEHOLDER CONSULTATION 

9.1  Social partner Consultation  

The  TFEU  foresees  a  two  stage  consultation  of  the  European  social  partners  for  legislative 
initiatives in the field of social policy (article 154). 

The Commission launched the first stage of consultation of the social partners on the protection 
of workers from risks related to exposure to carcinogens, mutagens and chemical agents toxic 
for reproduction at work on 6 April 2004. In accordance with Article 154(2) of the TFEU, the 
social partners were asked to give their opinions on the possible direction of EU action in this 
field. 

The first phase of the consultation confirmed that action needs to be taken at Community level 
to introduce better and standardised methods across the EU, and to tackle situations involving 
workers' exposure. 

All the European social partners who replied by the end of the six-week consultation period to 
the  consultation108  underlined  the  importance  they  attached  to  protecting  workers  from  the 
health risks associated with exposure to these chemical agents. 

However,  while  all  respondents  acknowledged  the  relevance  of  the  existing  legislation,  their 
views differed as to the strategy and direction of future action and which factors should be taken 
into consideration.109 

For example, whereas five organisations representing trade union umbrella organisations or the 
British  Occupational  Hygiene  Society  considered  to  be  appropriate  to  amend  or  update  the 
CMD,  three  other  organisations  representing  employers  felt  that  priority  should  be  given  to 
practical guidance documents and enhanced sectorial prevention. 

Regarding  the  extension  of  the  scope  of  the  CMD  to  cover  chemical  agents  toxic  for 
reproduction and the inclusion of more limit values in the Directive most replies were in favour 
of an EU initiative. On the other hand, social partners' organisations suggested that national and 
sectorial approaches were more appropriate to tackle the specific issue of workers exposure to 
environmental tobacco smoke. 

Following the first phase of consultation and due to the classification of respiratory crystalline 
silica as carcinogenic category 1 (proven carcinogen to humans) by IARC, the social partners of 
the  sectors  producing  (quarries)  and  using  silica  (construction,  glass,  metal  industry, 
pharmaceutical, etc.) embarked on negotiations in view of a European cross-sectorial agreement 
for  the  prevention  of  exposure  to  silica  respirable  dust.  Worker's  organisations  agreed  to 
negotiate  on  the  condition  that  any  future  agreement  would  be  without  prejudice  of  any  EU 
initiative setting adequate levels of protection at EU level. 

Once the Silica agreement was signed in 2006, the Commission launched on 16 April 2007 the 
second stage of consultation of the European social partners, in accordance with Article 154(3) 
of the TFEU on the content of the envisaged proposal. 

108 Union  of  Industrial  and  Employers'  Confederations  of  Europe  (UNICE),  European  Centre  of  Enterprises  with 
Public  Participation  and  of  Enterprises  of  General  Economic  Interest  (CEEP),  European  Association  of  Craft, 
Small  and  Medium-Sized  Enterprises  (UEAPME),  European  Trade  Union  Confederation  (ETUC),  European 
Confederation  of  Executives  and  Managerial  Staff  (CEC),  Confederation  of  National  Associations  of  Tanners 
and  Dressers  of  the  European  Community  (COTANCE),  Hotel,  Restaurants  and  Cafes  in  Europe  (HOTREC), 
European  Federation  of  Trade  Unions  in  the  Food,  Agriculture  and  Tourism  Sectors  and  Allied  Branches 
(EFFAT), Union Network International – Europe Hair & Beauty (UNI-Europa Hair&Beauty) 

109 CISNET EMPL 8676 of 15 June 2006 

69 

 
                                                 
The specific points for consultation were: 1) Inclusion of chemical agents toxic for reproduction 
(categories 1A and 1B) in the scope of CMD; 2) Updating OELs for chemical agents in Annex 
III of CMD; 3) Including OELs for more chemical agents in Annex III of CMD; 4) Introducing 
criteria  for  setting  OELs  for  CMR  chemical  agents;  and  5)  Focus  on  training  and information 
requirements. 

The Commission received replies from seven European social partner organisations: four from 
employers'  organisations  (Business  Europe,  Eurocommerce,  European  Association  of  Craft 
Small  and  Medium-sized  Enterprises  (UEAPME)  and  European  Cement  Industry),  two  from 
workers organisations (European Trade Union Confederation (ETUC), and European Federation 
of Building and  Woodworkers (EFBWW)) and  one from an independent  organization (British 
Occupational Hygiene Society (BOHS)). 

In their replies these organizations reaffirmed their approach to the prevention of occupational 
risks derived from carcinogens and mutagens at work, as outlined in their responses to the 1st 
stage consultation document. The opinions gathered are summarized below: 

Inclusion of chemical agents toxic for reproduction (categories 1A and 1B) in the scope of CMD 

There was no agreement on the need to initiate a EU level action, neither in the extension of 
the  scope  of  the  Directive  to  include  reprotoxic  chemical  agents  of  categories  1A  and  1B 
according  to  the  CLP  Regulation.  Employers  thought  that  the  effective  application  of  the 
existing legal framework is enough to attain a suitable level of protection, whilst workers called 
on  the  Commission  to  make  legislative  changes  and  to  commit  to  eliminate  exposure  to 
occupational carcinogens by 2025. Workers took a positive view in order to extend the scope of 
the Directive to cover reprotoxic chemical agents. The possibility of launching the negotiation 
procedure under Article 154 (4) and 155 of the Treaty was not agreed. 

Updating  OELs  for  chemical  agents  in  Annex  III  of  CMD  and  including  OELs  for  more 
chemical agents in Annex III of CMD 

There  was  a  partial  agreement  on  the  revision  of  existing  binding  OELs  and  on  the 
establishment of new OELs for chemical agents not yet listed in the Directive Annex III of the 
Directive.  While  workers  indicated  a  positive  attitude  based  on  the  fact  that  it  shall  ensure 
equivalent  protection  of  workers  at  EU  level,  the  employers  have  expressed  their  scepticism 
reasoning that this action could only be justified on the grounds of an evaluation of the Directive 
98/24/EC  on  chemical  agents,  on  the  grounds  of  robust  scientific  evidence  and  under  the 
condition that socio-economic and feasibility factors must be taken into account. Furthermore, 
the  revision  of  binding  OELs  should  be  examined  in  the  light  of  the  implementation  of  the 
REACH Regulation and of the relationship and interaction between OELs and DNELs (Derived 
Non Effect Levels) which will be derived under REACH for hazardous chemicals. 

Introducing criteria for setting OELs for CMR chemical agents 

There were no significant divergences between the replies of both employers and workers on 
the  methodologies  to  be  used  and  the  criteria  to  be  set  up  for  the  derivation  of  OELs.  The 
introduction  of  criteria  for  OELs  setting  was  seen  as  generally  positive.  However,  socio-
economic impact assessments and the consideration of feasibility factors should be part of the 
criteria. Social partners expressed the view that the ACSH should be involved. 

Focus on training and information requirements 

There  was  an  overall  agreement  on  the  need  for  effective  implementation  of  training  and 
information requirements. This issue is considered to be a key aspect of the prevention policy. 
Workers  call  the  Commission  to  set  up  a  strategy  to  improve  coordination  and  sharing  of 
information  at  EU  level.  Employers  see  an  added  value  on  the  preparation  of  guidance 
documents  with  recommendations  on  workers  protection  against  carcinogens  and  mutagens 
exposure. 

70 

 
Following  the  results  of  the  Social  Partners  consultation,  the  Commission  tendered  a  study  to 
assess socio-economic aspects of revising OELs and introducing new ones (see point 9.4.2). The 
results  of  the  study  as  well  as  SCOEL  recommendations,  where  available,  were  subsequently 
discussed by the tripartite ACSH. The discussions resulted in agreement on limit values, which 
have been taken forward to this initiative. 

9.2  Other consultation of stakeholders 

9.2.1  25 October 2006 - Workshop of setting OELs for Carcinogens 

In 2006, DG EMPL organised in collaboration with the ACSH a workshop on 'Setting OELs for 
Carcinogens'. The key questions addressed during the workshop were the following: 

  What is the acceptable/unacceptable level of risk? 
  What is the maximum level of risk? 
  Is it possible to quantify it in terms of incidence rate versus the number of exposed workers? 
  In accepting risk levels should a distinction be made for general public and workers? 
  What criteria are used in some Member States and what political decisions have been taken 

in respect to the OEL setting process for carcinogens? 

  What criteria should be used  to  define the border between the acceptable and unacceptable 

risk? 

  Should  the  approach  to  address  the  risk  levels  be  systematic  (quantitative/semiquantitative) 

or stochastic (case by case)? 

  Should criteria on the acceptability of risks be regulated at EU level? 
  Should  the  workability  of  the  existing  EU  legal  framework  be  safeguarded  versus 

subsidiarity, in terms of establishment of OELs for carcinogens? 

One of the main conclusions of the workshop was that the existing EU OSH legal framework 
and its supportive administrative, technical and scientific structure should remain in  place and 
be  used  for  the  derivation  and  adoption  of  OELs  at  the  EU  level.  However,  it  was  also 
acknowledged that the derivation of OELs for Carcinogens, Mutagens and Reprotoxic chemical 
agents  (CMRs)  -  both  genotoxic  and  non-genotoxic  -  is  a  demanding  task.  The  availability  of 
sound and sufficient evidence, and in particular the availability of criteria and methodologies for 
their derivation, is a critical prerequisite for setting OELs for carcinogens. 

More than 80 scientists, technicians and academics contributed to the discussions. 

9.2.2 EU-OSHA  -  Exploratory  survey  of  Occupational  Exposure  Limits  (OELs) 

for 
Carcinogens,  Mutagens  and  Reprotoxic  chemical  agents  (CMRs)  at  EU  Member  States 
level (published in September 2009)110 

Between  late  2007  and  early  2008,  EU-OSHA,  at  the  request  of  the  European  Commission, 
carried  out  a  survey  among  its  network  partners  aiming  at  increasing  the  Commission's 
knowledge on the existing situation at national levels concerning OELs for CMRs. 

Part of the survey was to collect data on existing OELs values for CMRs from the 27 Member 
States  and  from  selected  countries  outside  of  the  EU  (Australia,  Canada,  Japan  and  US).  In 
addition,  information  was  required  on  the  methodology  and  criteria  (scientific,  technical  and 
socioeconomic) used when setting an OEL for a carcinogen or a mutagen. 
Based on the feedback received, the final survey covered 21 Member States111. 

110https://osha.europa.eu/sites/default/files/publications/documents/en/publications/reports/548OELs/survey_OELs_

CMR_substances_web_def.pdf 

71 

 
 
                                                 
With regard to the current initiative it is worth noting that the chemical agents covered by this 
initiative are in many cases also included in national OEL lists for carcinogens and mutagens. 
The  majority  of  the  MS  which  reported  back  had  between  30  to  50  OELs  established  for 
carcinogenic and / or mutagenic chemical agents (Belgium, Czech Republic, Denmark, Estonia, 
Latvia, Lithuania, the Netherlands, Portugal, Slovakia, Slovenia, and UK), and only 4 EU MS 
(Austria, Finland, Poland and Spain) had listed a higher number than 50. 

With  regard  to  the selection  and  prioritization  of  carcinogenic  and  mutagenic  chemical  agents 
for OEL setting, it is also important with regard to the current initiative that criteria used in EU 
Member States were very similar to those used in the EU. 

Based on the answers of 11 countries, the most important criteria for the selection of chemical 
agents  for  setting  of  OEL  appeared  to  be  (in  order  of  priority):  (1)  epidemiological  evidence, 
including reported cases of ill-health in the workplace, (2) availability of toxicological data, (3) 
severity of effects, (4) number of persons exposed, (5) availability of data on exposure, and (6) 
availability of measurement methods. 

Results of the survey have been used to put together the lists of existing OELs in Annex 7. 

9.2.3 Consultation of the tripartite Working Party 'Chemicals at the Workplace' (WPCs) of the 

ACSH 

Following the Social Partner Consultation, the Commission informed the members of the WPC 
at its meeting in April 2008 on its intention to propose a revision of the CMD. Information were 
provided  on  a  possible  launch  of  a  call  for  tender  during  2008  with  a  view  to  appointing  a 
contractor to carry out an impact assessment of possible amendments of the Directive, covering 
amongst  other  the  inclusion  of  certain  PGSs  in  Annex  I  to  the  Directive  and  the  revision  of 
existing and the introduction of new OELs for a number of chemical agents in Annex III to the 
Directive (the so-called IOM study). 

At  that  point  in  time,  the  Commission  confirmed  that  the  option  of  covering  chemical  agents 
toxic  for  reproduction  under  the  scope  of  the  revised  Directive  was  now  excluded  by  the 
Commission. However, in 2010, the Commission launched another call for tender for a study to 
explore  whether  or  not  these  chemical  agents  should  be  under  the  scope  of  the  CMD  (the  so-
called RPA study). 
At  various  meetings  of  the  WPC,  the  progress  on  the  studies  was  discussed112,  followed  by  a 
first  more  in-depths  discussion  on  the  results  of  the  IOM  study  based  on  draft  reports  for 
individual  chemical  agents  in  March  2011.  The  discussions  on  the  individual  chemical  agents 
took  place  at  various  meetings  of  the  WPC  in  2011113,  2012114  and  2013115,  resulting  in  one 

111 Austria,  Belgium,  Cyprus,  Czech  Republic,  Denmark,  Estonia,  Finland,  Germany,  Greece,  Italy,  Latvia, 
Lithuania,  Luxembourg,  the  Netherlands,  Poland,  Portugal,  Slovakia,  Slovenia,  Spain,  Sweden  and  the  United 
Kingdom 

112 Meeting of the WPC on 15 October 2008; Meeting of the WPC on 26 March 2009; Meeting of the WPC on 20 

October 2010;  

113 Meeting  of  the  WPC  on  23  March  2011;  Meeting  of  the  WPC  on  15  June  2011;  Meeting  of  the  WPC  on  26 

October 2011 

114 Meeting  of  the  WPC  on  21  March  2012;  Meeting  of  the  WPC  on  6  June  2012;  Meeting  of  the  WPC  on  21 

November 2012 

115 Meeting  of  the  WPC  on  6  March  2013;  Meeting  of  the  WPC  on  19  June  2013;  Meeting  of  the  WPC  on  2 

October 2013 

72 

 
                                                                                                                                                            
opinion  and  two  supplementary  opinions  adopted  by  the  plenary  of  the  ACSH  in  2012116  and 
2013117, 118. 

The OEL values agreed upon by the ACSH were taken forward to this initiative. 

9.2.4 

September 2012 - Workshop in Berlin 

A workshop ‘Carcinogens and  Work-Related Cancer’ was organised by the European  Agency 
for Safety and Health at Work (EU-OSHA) and hosted by the German Ministry of Labour and 
Social  Affairs  at  their  offices  in  Berlin  on  3  and  4  September  2012.  About  60  representatives 
from various European countries, the European Commission, the Advisory Committee on Safety 
and Health’s Working Party on Chemicals, the Chemex group of the Senior Labour Inspectors 
Committee  (SLIC),  the  Scientific  Committee  on  Occupational  Exposure  Limits  (SCOEL),  the 
European Chemicals Agency and IARC of the World Health Organisation (WHO) attended. 

The  aim  of  the  workshop  was  to  summarize  the  current  understanding  regarding  exposures  to 
carcinogens and the causes and circumstances of work-related cancer, and to discuss how this 
knowledge  can  be  used  across  the  European  Union  (EU)  to  reduce  the  future  burden  of  these 
cancers. 
The  workshop119  highlighted  the  need  to  enhance  research  efforts  to  estimate  the  burden  of 
occupational disease and build on links between occupations and exposures to set priorities for 
prevention,  disease  recognition  and  compensation.  In  this  regard  the  on-going  study 
HazChem@Work will collect the available occupational exposure data on chemicals across the 
EU countries. Interim results of this study have shown difficulty in finding data on occupational 
exposure  as  it  is  not  routinely  collected  and  centralised  at  the  national  level.  It  is  been  also 
identified that the measurements can be performed under different conditions and for different 
purposes  –  this  can  hamper  the  comparability  among  different  data  sets.  The  final  results  are 
expected by the second semester of 2016. 

It was generally agreed that the current legislative framework in Europe and its implementation 
and enforcement is essential for the effective prevention of cancer in the workplace. The need to 
provide the same minimum level of protection to all workers was also stressed. 

9.2.5  Consultation of the members of the ACSH on existing national OELs for chemical agents 

subject to the amendments 

In order to establish a baseline scenario for the establishment of OELs subject to the initiative, 
the Commission services requested from the members of the ACSH at its plenary meeting on 28 
November  2013  to  submit  updated  information  on  the  national  OELs  for  the  chemical  agents 
covered by the IOM study. 

9.2.6  Meetings with Industry and Workers representatives 

Between the beginning of 2013 and  end of 2015, a number of  meetings between Commission 
services  and  industry  and  workers  representatives  concerned  about  specific  chemical  agents 
subject to the initiative took place. 

116 Opinion  on  the  approach  and  content  of  an  envisaged  proposal  by  the  Commission  on  the  amendment  of 
Directive 2004/37/EC on Carcinogens and Mutagens at the workplace. Adopted on 05/12/2012 (Doc. 2011/12) 
117 Supplementary  opinion  on  the  approach  and  content  of  an  envisaged  proposal  by  the  Commission  on  the 
amendment of Directive 2004/37/EC on Carcinogens and Mutagens at the workplace. Adopted on 30/05/2013 
(Doc. 727/13) 

118 Supplementary opinion No. 2 on the approach and content of an envisaged proposal by the Commission on the 
amendment of Directive 2004/37/EC on Carcinogens and Mutagens at the workplace. Adopted on 28/11/2013 
(Doc. 2016/13) 

119 The  seminar  report  is  available  at  https://osha.europa.eu/en/tools-and-publications/seminars/workshop-on-

carcinogens-and-work-related-cancer 

73 

 
                                                 
The following organisations, among others, discussed bilaterally with the Commission services 
on specific chemical agents subject to the initiative: 

  NEPSi  (European  Network  for  Silica  formed  by  the  Employee  and  Employer  European 

sectoral associations),  

  Euromines and IMA (Industrial Minerals Association) for Silica; 
  ECFIA (European Ceramic Fibre Industry Association) and Unifrax for Refractory Ceramic 

Fibers (RCF); 

  CEEMET (Council of European Employers of the Metal, Engineering and Technology-Based 

Industries) and Eurometaux for metals as Chromium and Beryllium 
  BeST (Beryllium Science & Technology Association) for Beryllium. 
  Rubber industry 

The  main  purpose  of  the  meetings  asked  for  by  industry  was  to  achieve  information  on  the 
process  for  amending  the  legislation  in  general,  and  on  the  intention  of  the  Commission  with 
regard to the proposed value for a particular chemical agent. 

Some  conclusions  can  be  drawn  from  these  meetings  regarding  the  position  of  the  industry 
representative organisations on specific substances. 

74 

 
 
10  ANNEX 3 – WHO IS AFFECTED BY THE INITIATIVE AND HOW? 

Who is affected 

National authorities  

How 

Given  the  substantial  economic  costs  imposed  on  workers  due  to  their 
exposure to hazardous substances, the retained option also contributes to 
mitigate financial loss of the Member State's social security system. 

Member  States  must  transpose  the  amended  Directive  into  national 
legislation:  

- assessment of the national scenario and potential impacts 
-  design,  if  appropriate/needed,  of  special  measures  (e.g.,  transitional 
periods, exemptions, additional provisions for specific sectors,…)  
- tripartite consultation of the proposal (workers, employers, authorities) 
-  facilitate  implementation  of  the  national  legislation  by  providing, 
among other measures, technical guidance to employers. These costs are 
minor in comparison to the overall costs of functioning incurred by the 
enforcement authorities. 
- enforce the national legislation. Introduction of new OELs in the CMD 
would  not  have  any  significant  impact  on  the  overall  costs  of  the 
inspection visits. Those are mostly planned independently of the revised 
legislation.  On  the  other  hand,  the  existence  of  an  OEL,  by  bringing 
clarity  regarding  the  acceptable  levels  of  exposure,  facilitates  the  work 
of inspectors by providing a helpful tool for compliance checks. 

The establishment of OELs at EU level eliminates the need for national 
public  authorities  to  independently  evaluate  each  carcinogen  thereby 
removing an inefficiency of repetition of identical tasks. 

Employers 

As  duty  holders,  employers  must  comply  with  the  whole  set  of  OSH 
national  legislation  provisions.  Given  the  nature  of  the  proposed 
amendment, this would mainly be:  

-  implementation  of  the  necessary  risk  management  measures  (eg., 
substitution,  closed  systems,  local  exhaust  ventilation,  limitation  of 
number of workers exposed, personal protection equipment) in order to 
comply with the new or revised OELs 
-  implementation  of  a  sampling  strategy  and  airborne  concentrations 
measurement programme for the chemical agents with a new or revised 
OEL, as part of the risk assessment process and effectiveness check of 
the existing measures 
- ensure that the chemical agents included in Annex I will be managed in 
line  with  the  provisions  of  the  carcinogens  and  mutagens  national 
legislation  
-  ensure  compliance  with  other  provision  in  the  legislation  (specific 
information and training to workers as regards the new working methods 
if  such  is  the  need  in  order  to  comply  with  the  new  OELs,  health 
surveillance, if appropriate, for chemical agents now under the scope of 
the 
to  competent 
authorities, etc.). 

legislation,  collection  of  records, 

information 

Most of the listed actions are, however, business as usual. 

The  benefits  for  employers  include,  inter  alia,  avoided  loss  of 
productivity,  legal  clarity  as  well  as  simplification  in  ensuring  legal 

75 

 
 
compliance. 

Workers 

As  protected  subjects,  workers  would  be  positively  affected  by  the 
initiative in terms of a more effective protection of their health. 

It  is  to  be  noted  that  workers  have  the  duty  to  apply  preventive  and 
protective measures set by the employers necessary to comply with OSH 
legislation (e.g., the newly established OELs). 

76 

 
 
 
11  ANNEX 4 – OVERVIEW OF THE SEVEN CARCINOGENS  

11.1  Sectors, types of cancer caused and estimated number of workers exposed 

Annex  4  Table  1.  Sectors,  types  of  cancer  caused  and  estimated  number  of  workers  exposed  for  seven  chemical 
agents under consideration120 

Carcinogen, 
including CAS 
numbers where 
relevant 

Classification  Key sectors/uses 
CLP122 IARC  

Types of cancer caused / 
other adverse health 
effects 

No. of 
exposed 
workers
121 

40,000 

Epichlorohydrine 

1B 

106-89-8 

(1-Chloro-2,3-
epoxypropane) 

2A123  Production of epoxy and 
phenoxy resins, 
manufacture of glycerine, 
curing of propylene-based 
rubbers, solvent for 
cellulose esters and ethers, 
and in resins with high 
wet-strength for the paper 
industry.124 

Ethylene dibromide 

1B 

2A125  Current use as a 

(EDB) 

106-93-4 

(Dibromoethane) 

chemical intermediate 
in synthesis and as a 
non-flammable solvent 
for resins, gums and 
waxes and has been 
used as an intermediate 
in the preparation of 
dyes and 
pharmaceuticals. 

Historically used as a 
'lead scavenger' in 
antiknock mixtures 
added to gasolines 
(which decreased with 
banning of lead-
containing fuels in 
many countries) and as 
a pesticide and 
ingredient in soil and 

Lung cancer. 

CLP harmonised 
classification, also: 

 
 

 
 

toxic if inhaled 
toxic in contact with 
skin 
toxic if swallowed 
causes severe skin 
burns 
 
causes eye damage 
  may cause an allergic 

8,000 

skin reaction. 
Caused tumours in rats 
and mice at several 
different tissue sites and 
by several different routes 
of exposure.127 

CLP harmonised 
classification, also: 

 
 

 
 

toxic if swallowed 
toxic in contact with 
skin 
toxic if inhaled 
causes serious eye 
irritation 
 
causes skin irritation 
  may cause respiratory 

irritation. 

120 Source:  IOM  Research  Project  P937/99,  May  2011  –  Health,  social-economic  and  environmental  aspects  of 
possible  amendments  to  the  EU  Directive  on  the  protection  of  workers  from  the  risks  related  to  exposure  to 
carcinogens and mutagens at work. This report is the source of all figures concerning the 12 chemical agents in 
the report , unless otherwise specified.  

121 Estimates, rounded  
122 Harmonised (i.e. mandatory) CLP classifications for carcinogenicity. 
123 IARC Monograph 11, Sup 7, 71, 1999 
124 SCOEL recommendation 169, 2011 
125 IARC Monograph 15, Sup 7, 71, 1999 

77 

 
 
 
                                                 
Carcinogen, 
including CAS 
numbers where 
relevant 

Classification  Key sectors/uses 
CLP122 IARC  

Types of cancer caused / 
other adverse health 
effects 

No. of 
exposed 
workers
121 

Caused tumours in mice 
and rats at several 
different tissue sites.130 

3,000 

CLP harmonised 
classification, also: 

  harmful if swallowed 
 
causes serious eye 
irritation 
 
causes skin irritation 
  may cause respiratory 

irritation.  

Liver and thyroid cancer 
in rats and mice133 

3,900,000 

CLP harmonised 
classification, also: 

 

 

suspected of causing 
genetic defects 
causes damages to 
organs (Specific 
Target organ toxicity 
after single exposure) 
  may cause damage to 
organs through 
prolonged or repeated 
exposure 

  may cause an allergic 

skin reaction 

Ethylene dichloride 

1B 

2B128  Production of vinyl 

grain fumigant 
formulations.126 

(EDC) 

107-06-2 

(1,2--Dichloroethane) 

4,4'-
Methylenedianiline 

1B 

2B131 

(MDA) 

101-77-9 

chloride to make a variety 
of plastic and vinyl 
products including 
polyvinyl chloride (PVC) 
pipes, furniture and 
automobile upholstery, 
wall coverings, 
housewares, and 
automobile parts. 

Also used to as a solvent 
and is added to leaded 
gasoline to remove 
lead.129 

Intermediate in the 
closed-system 
production of 4,4’-
diaminodiphenylmethan
e diisocyanate (MDI) 
and polyisocyanates. 

Also used as a cross-
linking agent for epoxy 
resins, in the 
determination of 
tungsten and sulphates, 
as an analytical agent, 
as a corrosion inhibitor, 
as an antioxidant and 
curative agent in rubber 
and to prepare azo dyes. 

Potential exposure 
occurs during 
production, packaging 
and reprocessing of the 
chemical and during its 
use in epoxy resins.132 

127 https://ntp.niehs.nih.gov/ntp/roc/content/profiles/dibromoethane.pdf 
126 SCOEL SUM 166. 
128 IARC Monograph 20, Sup 7, 71, 1999 
129 http://www.atsdr.cdc.gov/toxfaqs/tf.asp?id=591&tid=110 
130 https://ntp.niehs.nih.gov/ntp/roc/content/profiles/dichloroethane.pdf 
131 IARC Monograph 39, Sup 7 
132 SCOEL recommendation 107, 2012 

78 

 
 
                                                                                                                                                            
No. of 
exposed 
workers
121 

74,000 

7,000,000 

Carcinogen, 
including CAS 
numbers where 
relevant 

Classification  Key sectors/uses 
CLP122 IARC  

Types of cancer caused / 
other adverse health 
effects 

Trichloroethylene 

1B 

(TCE) 

79-01-6 

1134  Mainly used for vapour 
degreasing and cleaning 
of metal parts, in 
adhesives, as a solvent 
and for synthesis in the 
chemical industry, e.g. in 
the production of HFC 
134a and HCFC 133a.135 

Liver cancer, kidney 
cancer 

CLP harmonised 
classification, also: 

 

 

suspected of causing 
genetic defects 
causes serious eye 
irritation 
 
causes skin irritation 
  May cause drowsiness 

1B 

1136 

Complex PAH 
mixtures with 
benzo[a]pyrene as an 
indicator  

50-32-8 (for 
benzo[a]pyrene) 

or dizziness 

Multiple animal studies in 
many species 
demonstrating BAP to be 
carcinogenic following 
administration by 
numerous routes138 

CLP harmonised 
classification, also: 

  may cause an allergic 
skin reaction may 
cause genetic defects 
  may damage fertility 
  may damage the 
unborn child. 

Polycyclic aromatic 
hydrocarbons (PAHs), 
including the most 
hazardous example 
benzo[a]pyrene, are 
widespread 
environmental 
contaminants formed 
during incomplete 
combustion or pyrolysis 
of organic material. 

Industries where 
occupational exposure 
to benzo[a]pyrene has 
been measured and 
reported include: coal 
liquefaction, coal 
gasification, coke 
production and coke 
ovens, coal-tar 
distillation, roofing and 
paving (involving coal-
tar pitch), wood 
impregnation and 
preservation with 
creosote, aluminium 
production (including 
anode manufacture), 
carbon-electrode 

133 http://www.baua.de/en/Topics-from-A-to-Z/Hazardous-Substances/TRGS/pdf/910/910-4-4-

methylenedianiline.pdf?__blob=publicationFile&v=1 

134 IARC Monograph Sup 7, 63, 106, 2014 
135 SCOEL recommandation 142, 2009 
136 IARC Monograph Sup 7, 92, 100F, 2012 
138 http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-14.pdf 

79 

 
                                                                                                                                                            
Carcinogen, 
including CAS 
numbers where 
relevant 

Classification  Key sectors/uses 
CLP122 IARC  

Types of cancer caused / 
other adverse health 
effects 

No. of 
exposed 
workers
121 

Mineral Oils as Used 
Engine Oils 
(UEOs)139 

n/a 

1140 

manufacture, chimney 
sweeping, and power 
plants. 

Especially high 
exposures to PAHs are 
observed in aluminium 
production (Soderberg 
process) with values up 
to 0.1 mg/m3. Mid-
range levels are 
observed in roofing and 
paving (e.g. 0.01−0.020 
mg/m3) and the lowest 
concentrations (i.e. at or 
below 0.001 mg/m3) are 
observed in coal 
liquefaction, coal-tar 
distillation, wood 
impregnation, chimney 
sweeping and power 
plants.137 

Oils that have been used 
before in internal 
combustion engines to 
lubricate and cool moving 
parts. 

Used in automobile and 
motorcycle engines, diesel 
rail engines, marine 
engines, aeroengines, and 
in portable machinery 
including chain saws and 
lawn mowers. 

The composition of 
engine oils (and hence of 
used engine oils), changes 
continually to meet the 
requirements of newer 
engine designs and 
performance 
requirements, and to 
comply with EU 
legislation. 

Skin cancer 

1,000,000 

137 https://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-14.pdf 
139 SCOEL Opinion 2016/405, adopted on 09 June 2016 
140 IARC Monograph 33, Sup 7, 100F, 2012 for Mineral oils, untreated or mildly treated,  

80 

 
                                                 
Carcinogen, 
including CAS 
numbers where 
relevant 

Classification  Key sectors/uses 
CLP122 IARC  

Types of cancer caused / 
other adverse health 
effects 

No. of 
exposed 
workers
121 

The composition of 
mineral oils as used 
engine oils further varies 
with duration of use, 
engine temperatures and 
conditions, and other 
factors. 

11.2  Legal  and  policy  considerations  specific  for  the  proposal  -  Risk  management 

measures under CMD 

11.2.1  Annex I to the CMD – Process-Generated Substances (PGS) 

Many  industrial  processes  generate  contaminants  which  can  be  hazardous  to  health. 
Combustion,  mechanical abrasion  (sanding, grinding,  sawing)  or  other processes physically or 
chemically degrade the starting material. 

The  CMD  provisions  apply  to  any  substance  or  mixture  which  meets  the  criteria  for 
classification as a category 1A or 1B carcinogen and/or germ cell mutagen set out in Annex I to 
Regulation (EC) No 1272/2008141 (CLP Regulation), which applies in principle to all substances 
and  mixtures  supplied  (placed  on  the  market)  in  the  Union.  As  PGSs  are  not  'placed  on  the 
market',  the  CMD  provided  for  the  possibility  to  include  those  substances  and  processes  in 
Annex  I  to  the  Directive  in  order  to  facilitate  the  obligation  of  employers  to  perform  the  risk 
assessment  and  to  establish  the  necessary  protective  and  preventive  measures.  A  list  of 
identified  PGS  is  contained  in  CMD  Annex  I142.  The  previous  proposal  included  definition  of 
one PGS (respirable crystalline silica, RCS) and this report considers inclusion into Annex I of a 
further PGS, mineral oils as used engine oils. 
11.2.2  Annex III to the CMD – OEL143 

Occupational  exposure  limit  values  (OELs)  are  set  to  prevent  occupational  diseases  or  other 
adverse effects in workers exposed to hazardous chemicals in the workplace. Within the CMD, 
there  is  an  obligation  for  employers  to  ensure  that  limit  values  set  out  in  Annex  III  to  the 
Directive are not exceeded. OELs set out in Annex III to the CMD are risk-based144. 

OELs may be  ‘health based’ - an OEL of this type may be established where a review of the 
total  available  scientific  database  leads  to  the  conclusion  that  it  is  possible  to  identify  a  clear 

141 Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on 
classification,  labelling  and  packaging  of  substances  and  mixtures,  amending  and  repealing  Directives 
65/548/EEC and Directive 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1) 

142 See section 1.1.2, page 11 of SWD(2016)152/2. 
143 Scientific  Committee  on  Occupational  Exposure  Limits,  Methodology  for  the  Derivation  of  Occupational 

Exposure Limits: Key Documentation (version 7), 2013 

144 For some adverse effects (in particular genotoxicity, carcinogenicity and respiratory sensitisation) it may not be 
possible on present knowledge to define a threshold of activity. In such cases it must be assumed that any level 
of exposure, however small, might carry some finite risk and OELs for substances possessing these properties 
must be established following a risk-based approach. 

81 

 
 
 
                                                 
threshold dose/exposure level below which exposure to the substance in question is not expected 
to lead to adverse effects. 

OELs  for  carcinogens  often  cannot  be  'health-based'  because  for  many  carcinogens  no  such 
threshold  dose/exposure  level  can  be  established.    In  such  cases  exposure  at  any  level, 
theoretically,  results  in  risk  to  worker  health  –  therefore  an  OEL  set  for  a  non-threshold 
carcinogen is not fully protective of worker health and there is a remaining 'residual risk'. 

In  any  case,  in  addition  to  a  heath-based  threshold  dose  or  to  considerations  of  residual  risk, 
CMD OELs are always set taking into account technical and socio-economic feasibility factors. 

OELs set out in Annex III to the CMD are, therefore, usually not 'health-based'. 

Within  the  CMD,  there  is  an  obligation  for  employers  to  ensure  that  limit  values  set  out  in 
Annex III to the Directive are not exceeded. 

This report assesses the option of setting OELs for the majority, but not all, of the considered 
chemicals.  Exposures  occur  mainly  via  airborne  or  dermal  route  and  depending  on  the 
characteristics of the chemical OELs under this initiative may be expressed as: 

 
Inhalation, 8 TWA 
 
Inhalation, STEL 
  Other (notations), Skin 

Inhalation, 8 TWA 

It  is  normal  to  establish  OELs  for  exposure  via  the  airborne  route  in  relation  to  a  reference 
period of 8 hours (a typical working day). They are also normally set on the basis of a nominal 
40-hour working week and for a working lifetime. They will be expressed in units of mg/m3 or 
ppm.145  

Inhalation, STEL 

An 8-hour TWA OEL is the usual limit recommended by SCOEL for the purposes of preventing 
adverse  health  effects  arising  from  exposure  to  a  specific  substance.  There  will,  however,  be 
substances for which an 8-hour TWA OEL alone provides insufficient protection. In such cases 
SCOEL  may  decide  also  to  recommend  the  establishment  of  a  short-term  exposure  limit 
(STEL), usually involving a 15-minute reference period. 

STELs  are  needed  where  adverse  health  effects  (immediate  or  delayed)  are  not  adequately 
controlled by compliance with an 8-hour TWA. This is likely to arise for substances for which a 
critical effect is observed following a brief exposure (e.g. nuisance, irritation, CNS depression, 
cardiac sensitisation) and where the 8-hour TWA OEL is established at a level not very much 
lower  than  exposures  at  which  there  might  be  a  risk  of  short-term  effects  occurring.  Such  a 
situation will be apparent from an initial review of the data base. 

Even  when  there  is  compliance  with  an  8-hour  TWA,  there  will  be  variability  in  exposure 
around the mean value when measurements are made over shorter periods. SCOEL will derive 
STELs in situations where these variations are likely to produce exposures at levels sufficiently 
high to trigger adverse effects. 

Other (notations), Skin 

145 OELs are usually expressed as  milligram per cubic  meter (mg/m3) of air, which can be converted to parts per 
million (ppm) for gases and vapours, corresponding to cm3 of gases or vapours per m3 of air. At 1 atm and 25 °C, 
the conversion is 1 ppm = (the molecular weight of the compound) /24.45 mg/m3 

82 

 
                                                 
In  order  effectively  to  control  total  systemic  exposure  to  chemicals  at  the  workplace,  it  is 
necessary  to  take  account  not  only  of  exposure  by  the  inhalation  route,  but  also  of  dermal 
exposure,  which  may  lead  to  skin  penetration  and  a  consequent  increase  in  the  total  body 
burden.  Dermal  absorption  will  have  a  greater  relative  impact  on  total  body  burden  (and  thus 
present  a  greater  health  risk)  when  exposure  by  the  inhalation  route  is  controlled  to  relatively 
low levels, i.e. for substances which have low OELs. In some situations (e.g. field application of 
pesticides)  the  contribution  from  dermal  absorption  may  greatly  exceed  the  contribution  from 
respiratory intake. It is thus necessary to assign a ‘skin notation’ to some OELs in order to warn 
of the possible significant contribution of dermal absorption to the total body burden. 

It should be noted that a skin notation relates specifically to dermal absorption of the material 
(whether  as  solid,  liquid  or  gas),  i.e.  it  is  determined  by  the  toxicokinetic  properties  of  the 
material in relation to the level at which the OEL is established. It does not relate to and is not 
intended  to  give  warning  of  direct  effects  on  the  skin  such  as  corrosivity,  irritation  and 
sensitisation, criteria for which are described in in the CLP Regulation. 

12  ANNEX 5 – ANALYTICAL MODEL USED IN PREPARING THE IMPACT ASSESSMENT

146 

The impacts of the different policy options proposed in this impact assessment were quantified, 
to the extent possible, based on a methodology as described below147. 

12.1  Exposure estimation  

The following occupational exposure information was required for each substance for estimating 
the health impact of any changes in exposure: 

-  Prevalence of exposure by industry (current); 
-  Classification of industries into high, medium, low and background exposure, or a subset 

of these categories; 

-  Distribution  of  exposure  (the  geometric  mean  (GM)  and  geometric  standard  deviation 

(GSD), ideally by country, across industries, and 

-  Temporal change in exposure (% change per year) arising from general improvements in 
European workplaces and work processes, not taking into account the impact of changes 
to the Carcinogens Directive. 

The  graphic  below  provides  an  overview  of  the  general  procedure  used  for  estimating  the 
prevalence of exposure: 

Annex 5, Figure 1 

146 IOM Study Report Valuing health benefits 
147 The  methodology  was  developed  under  the  coordination  of  the  Institute  of  Occupational  Medicine  in 
collaboration  with  team  members  representing  the  following  entities:  the  Imperial College  of  London;  AMEC 
Environment & Infrastructure UK Ltd; the Finish Institute of Occupational Health; IRAS, University of Utrecht; 
IEH, Cranfield University. 

83 

 
 
 
                                                 
Exposure  prevalence  data  were  available  from  the  Carcinogens  Exposure  database  (CAREX), 
for  almost  all  agents  analysed  in  this  impact  assessment  Information  collected  from  trade 
associations and other stakeholders was used. 

The  information  from  CAREX  and  other  sources,  were  combined  with  data  from  Eurostat 
(number  of  workers  exposed  by  relevant  sector  of  activity)  to  obtain  estimates  of  exposure 
prevalence. 

The level of intensity was assessed using: 

-  Published scientific literature; 
- 

Information  from  European  Risk  Assessment  Reports  compiled  in  relation  to  the 
Existing Substances Regulations; 
Information provided by industry stakeholders. 

- 

The overall weighted geometric mean (GM) and geometric standard deviation (GSD) exposure 
level for each agent was estimated across all 'medium' and 'high' exposure industries across the 
EU using @Risk (Palisade Corporation, New York). 

Where possible, exposures were simulated using GM and GSD for each country. The number of 
values each industry contributed was weighted according to the number of workers exposed in 
that industry. 

Temporal changes in exposure were determined from information from the literature, which was 
ideally specific to the substance being considered but in situations where this was not available, 
the study relied on the results of a systematic review of the literature (Creely et al, 2007). 

12.2  Health impact – methodology for estimation of the current cancer burden (baseline) 

as compared with the policy intervention scenarios 

In order to assess the current burden of occupational cancer related to the exposure to substances 
subject to this impact assessment, the analysis made was built on work to quantify the burden of 
cancer due to occupation in Great Britain (Rushton at al, 2010). 

The primary measure of the burden of cancer used in this project was the attributable fraction 
(AF) i.e. the proportion of cases that would not occur in the absence of exposure; this was then 
used to estimate the attributable numbers. 

84 

 
 
 
The  estimates  were  made  considering  the  risk  exposure  period  (REP)  for  specific  types  of 
cancer:  for  solid  tumours  a  latency  of  10-50  years  was  assumed  and  for  haematopoietic 
neoplasms  0-20  latency  was  assumed.  The  proportion  of  the  population  ever  exposed  to  each 
carcinogenic agent or occupation in the REP was obtained from the ratio of the numbers ever 
exposed to the carcinogens of interest in each relevant industry/occupation over the total number 
of people ever employed. Estimates of employment turnover for grouped main industry sectors 
and  of  life  expectancy  were  used  to  estimate  the  exposed  population,  and  adjustment  factors 
were  applied to  the exposure prevalence  data to take account of the change  in  numbers in  the 
industry sector groups. 

The  attributable  fraction  (AF)  for  each  cancer/occupational  carcinogen  was  estimated  using 
Levin's method (Levin, 1953). 

The  relative  risk  (RR)  for  cancer(s)  in  question  for  the  relevant  agent  or  work  environments, 
were  derived  from  a  review  of  the  published  epidemiological  literature.  Risk  estimates  were 
obtained  from  key  studies,  meta-analyses  or  pooled  studies,  taking  into  account  quality, 
relevance  to  the  EU,  sample-size,  effective  control  for  confounders,  adequate  exposure 
assessment, and clear case definition. 

For predicting the future burden, the risk exposure windows were projected forward in time, and 
estimation  was  carried  out  for  a  series  of  forecast  target  years  (FTYs)  that  stretch  far  enough 
into  the  future  to  account  for  the  latency  of  cancers  initiated  at  the  time  when  the  study  was 
performed  (i.e.  the  decade  starting  2060).  Estimates  were  made  for  alternative  scenarios  of 
changes in exposure levels and proportions exposed, for example assuming the introduction of 
new or reduced exposure limits, which were assumed introduced in 2010. The projections were 
made  each  time  under  the  assumption  of  full  compliance  with  the  legislation  (i.e.  99%  of 
exposures less than the limit value). 

To  predict  future  cancer  numbers  based  on  the  pattern  of  past  and  current  exposure  either  a 
'static'  baseline,  where  no  change  in  exposed  numbers  or  exposure  levels  is  expected  beyond 
2010, or a 'dynamic' baseline was used, where current trends are forecast to continue until 2030. 

The socioeconomic health impacts of the different policy options were then assessed in terms of 
the  cost  of  the  disability  and  death  based  on  the  estimated  cancer  burden  under  each  policy 
option. 

In this respect, several approaches exist to assessing potential health impacts ranging from non-
monetary  approaches  such  as  Quality  Adjusted  Life  Years  (QALY),  Disability  Adjusted  Life 
Years (DALY) and Health Life Years (HLY) to monetary methods such as the Cost of Illness 
(COI), Value of Statistical Life (VSL) and Value of Life Year Lost (VLYL). 

As  part  of  this  study,  Imperial  College  have  developed  a  model  to  estimate  DALYs  based  on 
exposure  data  from  Institute  of  Occupational  Medicine  (IOM)  and  the  Finish  Institute  for 
Occupational Health. The DALYs uses time as a common metric taking into consideration both 
premature death and ‘healthy’ years lost due to problems associated with living with the disease 
or health condition (i.e. cancer for this study). DALYs are calculated as the sum of the years of 
life lost due to premature mortality (YLL) and the years lost due to disability (YLD): 

DALY = YLL + YLD 

Each  DALY  represents  one  lost  year  of  ‘healthy’  state.  The  DALYs  can  be  used  as  one 
approach  to  compare  different  options  (e.g.  cost  effectiveness  analysis)  especially  when 
different Occupational Exposure Limit (OEL) values have been proposed. Entec have also used 
the  underlying  data  developed  by  Imperial  College  to  attempt  to  monetise  health  impacts 
associated  with  introducing  EU-wide  OELs.  This  will  allow  for  a  more  formal  cost  benefit 
analysis  to  be  used  to  compare  different  policy  options.  This  paper  sets  out  this  approach  to 
monetising human health impacts. 

85 

 
The approach used to estimate a monetary value on changes in health impacts is dependent on 
the data  available such  as  the population  at risk (i.e. data on the exposed population)  and any 
evidence  of  dose-response  relationships.  Since  it  is  not  possible  to  develop  dose-response 
functions for each chemical agent, the approach to valuing changes in human health is based on 
estimating  the  monetary  loss  (damages  or  costs)  that  might  occur  if  no  changes  were  made 
(Business-As-Usual  scenario)  in  comparison  to  the  avoided  health  related  costs  under  the 
introduction  of  an  EU-wide  OEL  level(s).  The  difference  in  health  impacts  between  the  BAU 
scenario and the scenario(s) with an OEL is the main health benefits valued in this project. 

The valuation of health impacts are divided into two main aspects: 

Life  years  lost  –  This  is  calculated  by  using  the  year’s  life  lost  (YLL)  estimated  by  Imperial 
College  and  multiplying  this  with  a  valuation  of  the  Value  of  Life  Year  Lost  (VLYL).  This 
values the time (years) lost due to premature death. 

Cost of Illness (COI) – This is often the main market-based approach in relation to health impact 
(ECHA 2008)148. Depending on the valuations available, it can include the direct, indirect and 
intangible costs of cancer. This is a monetary cost of the time spent with cancer. In this study, a 
unit COI estimate is multiplied by the number of cancer registrations. 

Each of these two impacts is explained in more detail below as well as using willingness-to-pay 
(WTP) estimates as an alternative approach. 

Value of life years lost (VLYL) 

The years of life lost (YLL) are estimated by multiplying the number of disease specific deaths 
times  average  life  expectancy  after  average  age  at  death  from  the  specific  disease149.  EU  and 
Member State specific average life expectancies were used for this project. Essentially years of 
life lost are the difference between death and average life expectancy (‘premature death’). This 
is illustrated in Figure 2. 

148 (ECHA 2008) – Applying SEA as part of restriction proposals under REACH 
149 Data on disease specific deaths by age were not available so age weighting factors were not used.  

86 

 
 
 
 
                                                 
Annex 5, figure 2 DALY component: Years of life lost (VLL) 

Monetary  estimates  of  the  value  of  life  years  lost  (YLYL  or  sometimes  known  as  VOLY150) 
allows us to put a value on VLL. The latest EC Impact Assessment guidance applicable at the 
time of the study (EC 2009)151 suggested using estimates of €50,000-100,000 in Europe for the 
purpose of an Impact Assessment, if no more specific estimates are available. Markandya (2003) 
uses an estimate of €50,000 and is also used more widely in other assessing health policies such 
as CAFE. Therefore for the purposes of this study the €50,000 is used as a lower estimate and 
€100,000  as  an  upper  estimate.  This  should  therefore  help  encompass  the  uncertainties 
associated with the VLYL. 

These  valuations  are  increased  by  2%  each  year  in  the  future  in  part  to  present  costs  in  real 
terms (i.e. adjusting for inflation in prices) and to reflect societies increasing value attached to 
their health (as economic growth typically increases over a long period of time). 

The values originally reported in the IOM study, based on a constant discount rate of 4%. Given 
the  very  long  time  frame  considered,  and  in  line  with  the  guidance  in  the  Better  Regulation 
Toolbox,  they  have  been  recalculated  applying  a  declining  discount  rate  (4%  for  the  first  20 
years, 3% thereafter)152. 

Cost of illness (COI) 

Introduction 

The cost of illness (COI) is one of the most common market based approaches to valuing health 
impacts.  It  involves  multiplying  the  number  of  cancer  registrations  occurring  under  each 
scenario (i.e. with and without proposed changes) with the valuation for COI. 

The  COI  might  include  health  sector  costs  (direct  costs),  the  value  of  lost  productivity  by  the 
patient (indirect cost), and the cost of pain and suffering (intangible costs)153. This will however 
depend  on  data  availability  as  in  most  cases  intangible  costs  are  unlikely  to  be  included  in 
valuations of COI. These three components are described in Table 2. 

150 Value of Life Years (VOLY) 
151 EC (2015) Better Regulation Guidelines (19.5.2015). 

http://ec.europa.eu/smart-regulation/guidelines/docs/swd_br_guidelines_en.pdf  

152 This is consistent with some other European Commission studies and is standard practice for air quality under 

the Clean Air for Europe (CAFE) programme.  

153 http://www.cdc.gov/owcd/eet/Cost/3.html#costofillness 

87 

yearsnowdeathmax(Average life expectancy)1.00degree of disabilityYLLFull health 
 
 
  
 
                                                 
  
Annex 5 Table 2 Components making up a valuation of COI 

Components of the COI 

Description 

Direct costs 

These include both the direct medical costs and direct non-medical costs of the disease:  

  Direct medical costs can include costs associated with the direct treatment of pain, including 
analgesic medication, medical procedures and technology, hospitalisations, use of emergency 
department services, and physician office visits for pain (Fortner et al. 2003)154. 

  Direct non-medical costs might include: transportation related expenses, childcare expenses, 
household  expenses,  medicine  expenses,  household  assistance,  educational  materials  and 
counselling or psychotherapy. 

From a social perspective, it is also possible to divide the costs into costs borne by the health 
service and those borne on the household: 

  Costs 

to 

the  health  Service  –  hospitalisation,  medication,  emergency  (ambulance) 

transportation and care, outpatient and primary clinic 

  Costs  to  the  household  -  Out-of-pocket  payments  (user  fees)  for  hospitals  and  drugs, 
medication, transportation of the patient and family, costs for taking care of dependents and 
modifications in home as a result of illness 

Indirect  costs  or  productivity  losses  are  the  labour  earnings  that  are  forgone  as  a  result  of  an 
adverse  health  outcome.  The  decreased  productivity  can  be  a  result  of  illness,  death,  side 
effects, or time spent receiving treatment. Indirect costs include lost earnings and productivity 
of  both  patients  and  the  family  members  who  take  care  of  them.  For  some  diseases  with 
premature  death,  the  indirect  cost  is  the  loss  in  potential  wages  and  benefits.  Indirect  costs 
associated with premature death might be very high. Examples of indirect illness costs include  

  the  value  of  time  spent  when  unable  to  work  as  productively  because  of  an  illness  or  side 

effect,  

  earnings lost while travelling to health-care facilities, and  
  productivity losses associated with caregiver time.  

Indirect costs 

Intangible costs 

The  intangible  cost  components  of  illness  are  usually  substantial,  and  in  many  cases,  might 
dominate the policy agenda. Examples include  

  disfigurement (e.g., breast cancer with surgery),  
  functional limitations (e.g., paralysis from polio),  
  pain (e.g., rheumatoid arthritis or bone metastasis), or  
  fear (e.g., HIV, rabies, or bovine spongiform encephalopathy [BSE]). 

One approach to estimating the intangible costs is through willingness-to-pay (WTP) studies. 

Source: Centers for Disease Control and Prevention – U.S. Department of Human Health & Services: 

http://www.cdc.gov/owcd/eet/Cost/3.html#costofillness 

Estimating COI 

Outlined below is an approach to valuing COI for cancer (excluding intangible costs): 

Cost  of  Illness 
(COI) 

= 

Number  of  cancer 
registrations 

x 

( 

Direct  cost  per 
registration 

+ 

Indirect  cost  per 
registration 

) 

Where:  

Direct cost per 
registration 

= 

Direct outpatient 
costs 

+ 

Direct inpatient 
costs 

+  Direct homecare costs 

Indirect cost per 
registration 

=  Value of production  x 

( 

Production lost 
because of illness 

+ 

Production lost 
because of care-

) 

154 (Fortner  et  al.  2003)  –  “Description  and  Predictors  of  Direct  and  Indirect  Costs  of  Pain  Reported  by  Cancer 

Patients” – Journal of Pain and Symptom Management – Volume 25. No 1 January 2003. 

88 

 
 
 
 
                                                 
giving 

It is extremely difficult to  gather information required to estimate direct and indirect costs for 
each  type  of  cancer  and  estimate  values  of  production  and  production  lost  for  each  sector 
affected. In most cases, this information is not publicly available. Therefore, COI estimates have 
been taken from existing studies related to cancer. 
Rabl (2004)155 provides values of unit costs (i.e. per patient) that are used in France for different 
morbidity risks. It includes estimates for COI and willingness-to-pay (WTP) related to avoiding 
the suffering and inconvenience of disease. The COI includes direct and indirect costs of cancer 
but  not  the  intangible  costs  of  cancer.  Intangible  costs  are  however  included  in  the  WTP 
estimates. These estimates are set out in Table 3. 

Annex 5 Table 3. Estimated unit costs of cancer (€ 2009 prices) – except for NMSC  

Health endpoint 

Cost of Illness (COI) 

WTP to avoid suffering 

Cancer, fatal (per incident) 

Cancer, non-fatal (per incident) 

€ 48,601 

€ 48,601 

€ 1,768,256 

€ 486,271 

Note: Prices have been updated from USD to EUR using historical exchange rates for 2004 and updated to 2009 prices using the EU harmonised 
index of consumer prices (HICP).  

It was not possible to find an estimate for COI for each type of cancer and therefore the estimate 
(€  48,601)  is  used  for  all  cancers,  with  the  exception  for  nonmelanoma  skin  cancer  (NMSC) 
where there is a greater survival rate and costs of treatment may be less expensive. 

Costs for NMSC are presented in Table 4. Costs for NMSC are based on a simple meta-analysis 
of various studies examining the economic costs of NMSC. Of particular relevance was a study 
by Miljoministeriet (2004)156 in which the direct costs of NMSC and willingness to pay (WTP) 
studies  to  avoid  the  permanent  scars  were  reviewed.  The  study  (along  with  other  studies) 
suggests  that  NMSC  can  typically  be  treated  within  a  year  and  is  assumed,  in  general,  to  not 
result in death. 

The  WTP  to  avoid  scarring  (249,424  DKK  in  2002  prices)  is  taken  from  the  Miljoministeriet 
(2004)  study  and  converted  to  Euros  (€38,827  in  2009  prices)  and  is  used  as  a  high  estimate. 
The study also provides a possible low COI estimate of €2,926 (18,795 DKK in 2002 prices). A 
comparable estimate is also derived from Morris et.al (2005)157 which estimates COI at €2,601 
in 2009 prices (based on an estimate of £1,413 in 2002 GBP prices). The latter is used as the 
low estimate in the current analysis. 

155 Rabl (2004) – “Valuation of Health End Points for Children and for Adults”, Working Paper. 
156 Miljoministeriet  (2004)  -  "Valuation  of  Chemical  Related  Health  Impacts  -  Estimation  of  direct  and  indirect 
costs for asthma bronchiale, headache, contact allergy, lung cancer and skin cancer" - Report prepared by COWI 
A/S  for  the  Danish  Environmental  Protection  Agency  http://www2.mst.dk/udgiv/publications/2004/87-7614-
295-7/pdf/87-7614-296-5.pdf   

157 Morris  et.al  (2005)  -  "cost  of  skin  cancer  in  England"  -  Report  by  S.  Morris,  B.  Cox  and  N.  Bosanquet  for 
- 

Business 

Imperial 

College 

London 

Tanker 
http://www3.imperial.ac.uk/pls/portallive/docs/1/43013.PDF  

School, 

89 

 
 
 
 
 
                                                 
Another  study  by  O'Dea  (2009)158  estimated  the  overall  costs  of  NMSC  to  New  Zealand.  If 
divided by the number of incidents, this gives a broad estimate of €538 per incident (867 NZD 
in  2007/08  prices).  However  this was  excluded  as  the  per-registration  costs  was not  explicitly 
estimated and also may not necessarily be representative of costs for the EU. 

Annex 5 Table 4 Summary of cost variables used for NMSC only (€ 2009 prices) 

Cost/benefit elements  

VLYL - Each year lost 

COI or WTP - Unit cost (per cancer registration) 

Low scenario 

€ 50,393 

€ 2,601 

High scenario 

€ 50,393 

€ 38,827 (WTP) 

Note: As the WTP to estimate relates to not having permanent scars and does not include the costs associated with life years lost, the high 
scenario also incorporates the impacts of any life years lost. This differs from the approach used for other types of cancer whereby the WTP 
already includes life years lost (and is therefore excluded to avoid double counting benefits). 

There are relatively few alternative monetised estimates of COI for cancer in existing literature 
and therefore it is very different to understand how representative these costs are for the rest of 
Europe. Fortner et al. (2003) estimates the mean monthly direct medical and non-medical pain 
related costs per patient (in the US) at around $891 (~$10k p.a.), with a maximum cost of $20k 
per month. Rabl’s actual unit estimate of $54,970 (2004 USD price) would seem an appropriate 
estimate  for  cancer  treatment  in  the  EU  for  this  project,  when  taking  into  consideration  the 
typical times spent in cancer stages related to treatment. 

As part of the calculations to estimate the years lived with disability (YLD), Imperial College 
needed to estimate the mean duration spent in each cancer stage for each disease. The names and 
number  of  stages  presented  in  blue  in  Figure  3.  may  differ  in  existing  literature,  but  the 
increased segregation allows us to better assign time that may be spent in each cancer stage. 

The  health  impact  assessment  has  estimated  the  duration  of  time  a  patient  may  spend  in  each 
cancer  stage  and  what  proportion  survive  and  die  prematurely  from  cancer.  The  time  spent  in 
diagnosis and primary therapy is particularly relevant for assessing the costs of treatment. The 
time  spent  varies  significantly  with  each  type  of  cancer,  ranging  from  2  weeks  for  Non-
Melanoma Skin Cancer (NMSC) to up to 18 months for leukaemia. 

Taking  into  consideration  that  Fortner  et  al’s  mean  estimate  (~$10k  p.a.),  does  not  include 
indirect  costs  due  to  a  loss  of  productivity,  it  is  reasonable  to  assume  that  the  updated  Rabl 
estimate  (€  48,601)  is  suitable  for  the  purposes  of  this  study  in  the  absence  of  further  COI 
estimates for cancer. As with the estimate of VLYL, the COI unit cost is increased by 2% each 
year  to  account  for  inflation  and  discounted  using  a  4%  discount  rate  and  using  a  declining 
discount rate (for impacts occurring after 30 years). For sensitivity analysis, the discount rate is 
changed; using a declining discount rate and no discounting is also considered. 

Willingness to pay (WTP) 
An alternative to COI is Willingness-to-pay (WTP). WTP typically includes159 

(1) 
(2) 

Lost wages160; 
Medical expenses; 

158 O'Dea  (2009)  -  "The  estimated  costs  -  economic  and  human  -  of  skin  cancers  in  New  Zealand"  - 

http://www.niwa.co.nz/?a=103433 

159 See: http://www.ers.usda.gov/publications/aer784/aer784f.pdf 
160 In some instances with premature death, this term drops out the calculations of WTP unless a bequeath motive is 

specified 

90 

 
 
 
 
                                                 
(3) 
(4) 

The monetary value of the disutility of illness; and 
The impact of preventive expenditures. 

The WTP estimates reflect what people are willing to pay to avoid the having cancer (both fatal 
and  non-fatal).  These  estimates  also  include  intangible  costs  which  are  very  difficult  to  value 
within COI estimates (i.e. 3 and 4). WTP costs are significantly higher than the COI estimates 
which  only  estimate  those  impacts  which  can  be  calculated  using  market  prices.  It  has  been 
suggested that the COI can be used as a lower bound to WTP estimates. For the purposes of this 
study,  the  low  benefits  scenario  is  estimated  using  COI  +  YLYL  and  the  high  scenario  using 
WTP  only.  The  reader  can  make  their  own  judgement  on  either  COI  should  be  viewed  as  a 
lower bound to the WTP results. 

In order to use the estimate for the WTP to avoid suffering under each scenario, it is necessary 
to be able to split cancer registrations to those that result in fatalities (premature death) and those 
which result in non-fatal cancers. It is however very difficult to make this split without making 
critical assumptions, since most studies are based on cancer survival times in intervals of 1, 5 
and 10 years rather than fatal and non-fatal cancers. It is not possible for this study, to determine 
(with sufficient confidence) what proportion of cancer registrations will be fatal and non-fatal. 
Since WTP is used as a high cost scenario, the WTP estimate for fatal cancers is used (€1.8m). 
Since NMSC is not considered to necessarily be fatal a lower WTP is used (€38,827). 

It is recognised in reality, that the average proportion of cancer registrations being fatal or non-
fatal may vary depending on several factors such as; the type, size and spread of the cancer (e.g. 
can vary depending on if the cancer has been identified at an early or late stage) and the patient 
itself; age, gender, general health, marital status and income level. However the range of costs in 
the low and high scenarios might provide a useful comparison to the reader. 

Summary – values used in this study 

The tables below summarise the cost variables used in the study. Table 5. summaries the costs 
variables  used  in  this  study  for  all  types  of  cancer,  with  the  exception  for  nonmelanoma  skin 
cancer  (NMSC)  where  there  is  a  greater  survival  rate  and  costs  of  treatment  may  be  less 
expensive. The costs specifically for NMSC are summarised in Table 6. 

Table 5. Summary of cost variables used in this study for all cancers except NMSC (€ 2009 prices) 

Cost/benefit elements  

VLYL - Each year lost 

Low scenario 

€ 50,393 

High scenario 

€ 0 (note 1) 

COI or WTP - Unit cost (per cancer registration) 

€ 49,302 (COI) 

€ 1,793,776 (WTP) 

(Note 1) – By using WTP (€1.8m) in the high scenario instead of COI, the WTP can include the costs of premature death and therefore there was 
a risk of double counting benefits if VLYL costs were included. 

Table 6. Summary of cost variables used for NMSC only (€ 2009 prices) 

Cost/benefit elements  

VLYL - Each year lost 

COI or WTP - Unit cost (per cancer registration) 

Low scenario 

€ 50,393 

€ 2,601 

High scenario 

€ 50,393 

€ 38,827 (WTP) 

Note: As the WTP to estimate relates to not having permanent scars and does not include the costs associated with life years lost, the high 
scenario also incorporates the impacts of any life years lost. This differs from the approach used for other types of cancer whereby the WTP 
already includes life years lost (and is therefore excluded to avoid double counting benefits). 

91 

 
 
 
 
12.3  Compliance costs 

In order to assess the compliance costs of meeting the proposed amendments to the Directive, 
particularly the introduction of a limit value, the main uses leading to exposures that are a risk to 
human health were identified. Minor uses were considered but not assessed. 

Consideration was given to possible risk management measures (RMM) that may be applied in 
order to meet the investigated OEL and whether these RMMs may have already been applied - 
in some countries or all EU countries. Background information on all agents in the project was 
obtained from published literature and stakeholder contacts to identify: 

- the uses and activities that lead to workplace exposure risks to human health; 
- the structure of the sectors in which exposure occurs; 
- exposure control measures currently in place, available and required to meet the proposed OEL 
and 
- the possible costs of exposure control measures. 

In order to understand the economic impacts on sectors in which specific uses cause a risk to the 
health  of  workers,  the  contractor  has  used  Eurostat  data  about  the  number  of  enterprises 
operating in different sectors, the number of enterprises in the EU, and financial measures such 
as turnover, personnel costs and research and development expenditure. 

Estimates were made of: 

- the number of firms needing to apply RMMs and the cost of the RMMs over the same time 
period as health benefits (2010-2069); 
- the cost of the administrative procedures of implementing the OEL (e.g. the cost of monitoring 
and audit); 
-  the  potential  effect  on  the  market  for  the  substance  by  the  imposition  of  the  OEL  –  i.e.  the 
change  in  the  market  for  the  substance  as  a  result  of  increased  cost  of  control  –  leading  to 
adoption of substitutes and possible change in price of the substance itself. 

The final analysis comprises a comparison of the costs and benefits of the 'baseline (do nothing)' 
option  with  the  scenario  in  which  the  possible  OEL  is  added  to  the  CMD  Directive  over  the 
analysis time frame i.e. 2010-2069. 

12.4  Analytical assumptions and challenges 

IOM exposure and cancer incidence estimates 

Exposure estimates, derived from the IOM study, are based on the assumption that for many of 
the  concerned  chemical  agents,  past  trends  of  declining  exposures  will  continue.  These  trends 
were  related  to  technological  progress,  changes  in  work  organisation  and  relative  weight  of 
different  industrial  sectors  but  also  to  past  legislative  developments.  It  is  difficult  to  predict 
whether  such  trends  would  indeed  continue  in  the  absence  of  further  EU  action.  The  60-year 
time  frame  of  the  assessment  poses  also  the  challenge  of  anticipating  future  industrial 
developments whereby uses of the chemical agents under consideration could either decline or 
grow and where potential new uses could lead to new workplace risks. 

Another important assumption in the study is that for some of the chemical agents the industry 
has already achieved relatively low exposure levels, sometimes lower than the proposed OELs. 
Generally speaking, however, even where it is estimated that current exposure levels are already 
very  low,  lack  of  EU  OELs  or  too  high  EU  OELs  mean  that  it  will  still  not  be  clear  for 
employers  and  workers  and  enforcing  authorities  whether  the  achieved  exposure  level  is 
satisfactory from the point of view of compliance with the minimisation principle of the CMD. 

92 

 
 
Table 1 in Annex 7 presents the current limit values in the EU Member States. The information 
regarding existing national OELs was gathered through an extensive 2014  survey. Lack of EU 
action will most likely mean that there will remain Member States where no limit values exist 
for certain carcinogens or where those values are too high to ensure adequate worker protection. 
A  minimum  standard  across  the  EU  will  not  be  ensured,  to  the  detriment  of  both  worker 
protection and the internal market. 

Methodological challenges (section 5) 

  For  most  chemical  agents  under  consideration,  data  on  the  number  of  workers  exposed  is 
scarce  and  unreliable  and  data  on  the  current  exposure  levels  across  EU  Member  States  is 
generally not  available. Member States  record statistics relating to  cancer  in  different  ways 
which cannot be readily aggregated. Where exposure data is available, its use as an evidence 
base  for  regulatory  decision-making  is  often  confounded  by  the  sensitive  and  sometimes 
confidential nature of the information, and the potential for source bias. 

  For  many  of  the  carcinogens,  the  baseline  scenario  taken  from  the  IOM  study  foresees  a 
constant reduction in average exposure levels (e.g. of 7% annually). This projection of future 
exposure levels is obtained by extrapolating past declining trends in average exposure levels. 
However, for some substances this (large) declining trend assumption is contested by other 
studies.161 In addition, even when declining trends in average exposure levels are observed, it 
may  be  misleading  to  regard  these  as  exogenous.  Recent  reductions  in  exposure  may  have 
been  precisely  the  result  of  OELs  having  been  introduced  or  as  an  anticipation  of  those 
changes.  With  respect  to  the  cost  and  benefit  analysis,  therefore,  the  projected  decline  in 
average  exposure  levels  under  the  baseline  scenario  may  bias  the  estimated  health  impacts 
downward. 

  The available epidemiologic evidence is scarce and not always sufficiently robust, inevitably 
affecting  the  reliability  of  the  derived  estimates  for  the  number  of  cancer  registrations  and 
deaths. Among the factors contributing to the scarcity of reliable data are the complexity of 
cancer  development  and  also  of  workplace  exposures.  Different  carcinogens  can,  for 
example, result in the same type of cancer (e.g. lung cancer), and occupational exposure to 
hazardous  agents  is  characterised  by  simultaneous  exposure  to  multiple  chemical  agents.  It 
can therefore be difficult to establish a causal relationship between cancer cases and exposure 
to a specific carcinogen. 

  The cost-benefit analysis underestimates benefits as only the cancer-related health impact is 
considered.  Exposure  to  the  chemical  agents  under  consideration  is  also  associated  with 
additional  non-cancer  health  effects  which  can  induce  further  health  costs  (such  as  for 
example severe skin damage, respiratory diseases, skin or eye irritation). 

  When  a  declining  trend  exposure  is  considered  under  the  baseline  scenario,  it  would  be 
incorrect to factor in among the costs of compliance with OELs based on the proposed OEL 
the  full  value  of  the  investment  required  to  reduce  exposure:  such  investment  would  have 
occurred  in  any  case  also  under  the  baseline  scenario  (in  order  to  justify  the  decline  in 
exposure), but possibly only later or more gradually over time. As a result the cost estimates 
of introducing an OEL reported in the IOM study would be overestimated. 

Finally, to allow for a comparison between the monetised health benefits and compliance costs, 
the  net  present  values  of  the  streams  of  costs  and  benefits  over  the  60-year  period  under 
consideration are computed. The values originally reported in the IOM study were based on a 
constant discount rate of 4%.  Given the very  long timeframe considered, and in line with the 

161 Exposure to carcinogens and work-related cancer: a review of assessment methods, EU-OSHA 2014, Available 
at https://osha.europa.eu/en/tools-and-publications/publications/reports/report-soar-work-related-cancer/view 

93 

 
                                                 
Better Regulation Toolbox, they have been recalculated applying a declining discount rate (4% 
for  the  first  20  years,  3%  thereafter).162    Still,  benefits  estimates  are  disadvantaged  as 
discounting  reduces  much  more  the  present  value  of  impacts  taking  place  in  the  longer  term 
(typically  health  benefits)  than  those  happening  at  the  beginning  of  the  period  (typically 
compliance costs). 

As it was not possible to obtain new estimates of health benefits assuming a constant level of 
exposure under the baseline scenario for all chemical agents, the costs presented in the IA report 
are indicative estimates of the actual additional costs of compliance assuming some delay (e.g. 
of  10-20  years)  in  the  realisation  of  the  investment  needed  to  achieve  a  certain  level  of 
compliance. 

The lack of reliable exposure data on both the numbers of workers exposed and on the levels of 
exposure  is  recognized.  To  address  this  data  gap  the  Commission  initiated  a  study  in  2013163 
which is expected to contribute to a better definition of the baseline situation for possible future 
initiatives on developing OELs for other priority occupational carcinogens. 

13  ANNEX 6 – CARCINOGENICITY OF THE CHEMICAL AGENTS  

The  table  below  summarises  the  current  situation  as  regards  the  availability  of  SCOEL 
Recommendations for the seven chemical agents in question. 

Table 1. Current situation regarding SCOEL Recommendations for chemical agents in the present proposal. 

Chemical Agent 

1,2-Dibromoethane 

CLP 
Harmonised 
Class. 
1B 

IARC 
Class. 

SCOEL 
Recommendation 

Year 

Comments 

2A 

SCOEL SUM 166  2011 

1,2-Dichloroethane 

1B 

2B 

Benzo[a]pyrene 

1B 

1 

SCOEL/REC/302  2016 
under 
public 
consult
ation 
until 30 
Novem
ber 
2016  
2016 

SCOEL/REC/404
164 

Epichlorohydrine (1-
Chloro-2,3-epoxypropane) 

1B 

2A 

SCOEL/SUM/169  2011 

MDA (4,4'-
Methylenedianiline) 

1B 

2B 

SCOEL/SUM/107  2012 

The substance is a genotoxic 
carcinogen without a 
threshold, SCOEL Group A 
The substance is a genotoxic 
carcinogen without a 
threshold, SCOEL Group A 
The chemical agent is worked 
on by SCOEL. Project stage is 
40.20.  

The substance is a genotoxic 
carcinogen without a 
threshold, SCOEL Group A 
The chemical agent is worked 
on by SCOEL. 
The substance is a genotoxic 
carcinogen without a 
threshold, SCOEL Group A 
The substance is a genotoxic 
carcinogen without a 
threshold, SCOEL Group A 

162 This is consistent with some other European Commission studies and is standard practice for air quality under 

the Clean Air for Europe (CAFE) programme. 

163 Call  for  tender  no.  VT/2013/079.  Service  contract  to  create  a  database  and  develop  a  model  to  estimate  the 
occupational  exposure  for  a  list  of  hazardous  chemicals  in  the  Member  States  of  the  European  Union  and  the 
EFTA/EEA countries. The contract with the successful bidder, VC/2014/0584, was signed on 23 July 2014. 

164 The  SCOEL 

recommendation  deals  with 

'Polycyclic  Aromatic  Hydrocarbon  mixtures  containing 

benzo[a]pyrene' 

94 

 
 
                                                 
Mineral oils as Used 
Engine Oils 

Trichloroethylene 

n/a 

1B 

1 

1 

SCOEL/OPIN/20
16-405 

June 
2016 

SCOEL/SUM/142  2009 

The substance is a genotoxic 
carcinogen without a 
threshold, SCOEL Group A 
The substance is a genotoxic 
carcinogen, SCOEL Group C 

14  ANNEX  7  -  EXPOSURE  LIMIT  VALUES  IN  EU  MEMBER  STATES  AND  SOME  NON-EU 

COUNTRIES 

14.1  Annex 7 Table 1. OELs165 in EU MS 

Carcinogen 
 

ECH 

EDB 

EDC 

MDA 

TCE166 

BAP 
(re 
PAHs) 

Mineral 
Oils 
(re used 
engine 
oils) 

106-89-8  106-93-4  107-06-2  101-77-9 

79-01-6 

50-32-8   

CAS 
proposed 
OEL 
(mg/m3) 
notation 
AT 

BE 
BG 
CY 
CZ 
DE 
DK 
EE 
EL 

ES 
FI 
FR 
HR 
HU 
IE 
IT 

1.9 

0.8 

8.2 

0.08 

8TWA 
55 
(10 ppm) 

STEL 
165 
(30 ppm) 

12(167) 

0.8(168) 

20 

skin 

0.1(169) 

3.3 

13.2 

2 

1 
8 
1.9 

10 

1.9 
1.9 
(176) 
1.9 
1.9 
2 
2 

145 
1(173) 

1 

4 

3.9 
0.78 

3.9 
0.8 
4 

41 
4 
412 
10(174) 

4 

40 

20 
4 
40 
21 
10 
20 
412 

0.82 

0. 1 
0.7 
0.8 

0.8 

0.82 
0.08 

0.8 
0.81 
0.08 

skin 

5(172) 
5 
5 
5 

0.005(170) 
0.002(171) 

0.00015 

0.005 
0.0007 

55 
135 
535 
250 
60 
55 

137 

750 

20 

538 

1080 

0.005 

5 

55 
50 
405 
550 

54 

0.01 

0.005 
0.002 

1080 
820 

137.5 
140 

5 
5(175) 

0.2(177) 
5(178) 

165 Values  relate  to  exposure  by  the  inhalation  route,  8  hr  TWA,  unless  otherwise  stated.    Short  Term  Exposure 

Limit (STEL) values set at MS level are referenced in relation to TCE. 

166 In converting the units for Trichloroethylene values from ppm into mg/m3, the latter has been round up to the 

nearest whole number.  

167 Also notation for 'skin' and an equivalent for 'sensitisation'. 
168 Also skin notation. 
169 Also notations for 'skin' and 'skin sensitisation'. 
170 For 'strong pitch preparation and loading, outside the range of coke ovens'. Also notation 'skin sensitisation'. 
171 For 'for the rest'.  Also notation 'skin sensitisation'. 
172 BE  value  covers  only  a  sub-group  ("Paraffin  oils")  of  what  has  been  evaluated  by  SCOEL  ("Mineral  Oils  as 

Used Engine Oils"). 
173 Also skin notation. 
174 Ibid. 
175 For 'oil mist'. 
176 FR only adopted STEL value of 10 mg/m3. 
177 Used in metal working (Inhalable). 
178 For 'mineral oil mist'. 

95 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Carcinogen 
 

ECH 

EDB 

EDC 

MDA 

TCE166 

CAS 
LT 
LU 
LV 
MT 
NL 
PL 
PT 
RO 
SE 
SI 

SK 

UK 

106-89-8  106-93-4  107-06-2  101-77-9 

79-01-6 

1.9 

1 

10 

0.19 
1 

0.002 
0.01 

1 
1.9 
12 

12 

1.9 

0.8 

0.8 

0.8 

3.9 

412 

10 

7 
50 

30 
4 
20 

20 

21 

0.009 
0.08 

0.8 

0.1 

0.08 

50 

10 
55 

50 

100 
50 
270 

275 

550 

134 

137.5 

100 

150 
140 
1080 

820 

BAP 
(re 
PAHs) 

Mineral 
Oils 
(re used 
engine 
oils) 

50-32-8   
0.002 

1 

0.00015 

0.00055 
0.002 

5 
- 
5 
5(179) 

0.002 
0.005(180) 
0.002(181) 
0.005(182) 
0.002(183) 

1 

179 For 'mineral oils highly refined excluding lubricants'.  Inhalable fraction. 
180 For 'coking'. 
181 For 'others'. 
182 For 'coke'. 
183 For 'others'. 

96 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
14.2  Annex 7 Table 2. OELs in EU MS – compared to levels recommended by the ACSH (option 2) 

Carcinogen 
[proposed EU OEL](184) 
Epichlorohydrine 
[1.9 mg/m3, sk.] 
Ethylene dibromide (EDB) 
[0.8 mg/m3, sk.] 
Ethylene dichloride (EDC) 
[8.2 mg/m3, sk.] 
4,4'-Methylenedianiline (MDA) 
[0.08 mg/m3, sk.] 
Trichloroethylene (TCE) 
[8TWA 10 ppm, 54.7 mg/m3  
STEL 30 ppm, 164.1 mg/m3, Sk.] 
Complex PAH mixtures with 
benzo[a]pyrene as an indicator 
[N/A] 
Mineral Oils as Used Engine Oils 
(UEOs) 
[Skin notation only] 

MS having no or higher OEL (8-hr TWA) 

AT, BE, BG, CY, DE, EE, EL, FR(185), IE, IT, LU, MT, PT, SI, SK 

BE, BG, CY, CZ, DE, DK, EE, EL, ES, FR, HR, IE, IT, LT, LU, LV, MT, PT, (SE186), UK 

AT, BE, CY, CZ, DE, EE, EL, ES, FR, HR, HU, IE, IT, LT, LU, LV, MT, PL, PT, RO, SI, SK, UK 

AT, BE187, BG, CY, CZ, DE, DK, EE, EL, ES, FR, HR, HU, IT, LT, LU, LV, MT, PT, RO, SE, SI, SK 
The UK has also adopted a Biological Monitoring Guidance Value of 50 µmol MDA /mol in urine.(188) 
BG, CY, CZ, DE, EE, EL, FR, HR, HU, IT, LU, NL, PT, RO, SI, SK, UK 

Total 
number  
15 

(20)19 

23 

23(189) 

17 

15 EU MSs (AT, BG, CZ, DE, EL, FI, HR, HU, LT, LV, NL, PL, SE, SI, SK) have OELs established at national level, varying 
between 0.022 mg/m3 (DE) to 0.00015 mg/m3 (BG and LV) 
UK has also adopted a Biological Monitoring Guidance Value of 4 µmol 1-hydroxypyrene/mol creatinine in urine.(190) 
13  MSs  (BE,  BG,  CY,  CZ,  EL,  FI,  IE,  IT,  LT,  LV,  NL,  PL,  SK)  have  adopted  national  OELs,  all  but  one  (LT)  for  5  mg/m3. 
However, the definition of what is covered by the entry differs considerably between MS 

184 8 hr TWA unless otherwise stated 
185 FR has not adopted an 8 hrs TWA value but STEL values, which are in the same range of STEL values of other MSs which have adopted a value two times higher than the proposed 

ACSH OEL 

186 According to the EMPL B3 questionnaire circulated in December 2013  to the MSs in order to get information about their OELs for the substances concerned, Sweden replied that  

"Handling of this substance requires authorization from the Swedish Work Environment Authority. So Sweden should not really be counted in this list. 

187 BE supports a lower EU OEL than in its own national legislation 
188 http://www.hsl.gov.uk/media/66141/4.4%20methylenedianiline_layout%201.pdf 
189 3 out of these 23 MSs (AT, CZ, SK) have national OELs very close to the one proposed (0.1 mg/m3 instead of 0.08 mg/m3), which might be just the result of different ways of 

presenting and rounding values 

190 http://www.hsl.gov.uk/media/1644/pah.pdf 

97 

 
 
 
                                                 
14.3  Annex 7 Table 3. OELs in some non-EU countries191 

Australia 

Canada  

US 

China 

Switzerland 

New Zealand 

Japan 

Singapore 

South Korea 

7.6 mg/m3 
2 ppm 

no value 

40 mg/m3 
10 ppm 

0.81 mg/m3 
0.1 ppm  

54 mg/m3 
10 ppm  

Ca-O: 0.5 ppm 
Ca-Q: 2 ppm 

Ca-O: no value  
Ca-Q: no value 

NIOSH: No value  
OSHA: 19 mg/m3; 
5ppm 
OSHA: 20 ppm 
NIOSH: 0.045 ppm 

1 mg/m3 

No value 

8 mg/m3 
2 ppm  

0.8 mg/m3 
0.1 ppm  

1.9 mg/m3 
0.5 ppm 

3.9 mg/m3 
0.5 ppm  

No value  

7.6 mg/m3 
2 ppm 

1.9 mg/m3 
0.5 ppm 

No value 

No value 

No value 

Ca-O: 10 ppm 
Ca-Q: 4 mg/m3, 1 
ppm  

NIOSH: 4 
mg/m3;1ppm 
OSHA: 50 ppm 

Ca-O: 0.04 mg/m3 
Ca-Q: 0.1 ppm, 0.81 
mg/m3 

NIOSH: no value 
OSHA: 0.01 ppm 

Ca-O: 10 ppm 
Ca-Q: 269 mg/m3, 50 
ppm 

NIOSH: 25 ppm 
OSHA: 100 ppm 

7 mg/m3 

20 mg/m3 
5 ppm  

21 mg/m3 
5 ppm  

10 ppm 

40 mg/m3 
10 ppm 

40 mg/m3 
10 ppm 

No value 

0.1 mg/m3 

0.08 mg/m3 
0.01 ppm  

0.4 mg/m3 

0.81 mg/m3 
0.1 ppm  

0.8 mg/m3 
0.1 ppm  

30 mg/m3 

110 mg/3 
20 ppm 

269 mg/m3 
50 ppm 

135 mg/m3 
25 ppm 

269 mg/m3 
50 ppm 

270 mg/m3 
50 ppm 

EU 

Carcinogen 
[proposed 
OEL]192 
Epichlorohydrine 
[1.9 mg/m3, sk.] 

Ethylene 
dibromide (EDB) 
[0.8 mg/m3, sk. – 
0.1 ppm] 
Ethylene 
dichloride (EDC) 
[8.2 mg/m3, sk. – 
2 ppm] 
4,4'-
Methylenedianilin
e (MDA) 
[0.08 mg/m3, sk.] 
Trichloroethylene 
(TCE) 

[8TWA 10 ppm, 
54.7 mg/m3  
STEL 30 ppm, 
164.1 mg/m3 
Sk.] 

191  
192  

Values or cells marked in red indicate OELs lower than the option retained. 

8 hr TWA unless otherwise stated 

98 

 
 
 
 
 
                                                 
14.4  Annex 7 Table 4. Exposures in Member States which have no OEL or an OEL 
higher that the retained option  

(where relevant and data is available) 

15  ANNEX 8 - RELEVANT EU LEGISLATION 

15.1  Existing EU-OSH framework 

15.1.1  Directive 89/391/EEC 

The  aim  of  the  Framework  Directive  is  to  introduce  measures  to  encourage 
improvements in the safety and health of workers at work. To this end it contains general 
principles  concerning  the  prevention  of  occupational  risks,  the  protection  of  safety  and 
health, the elimination of risk and accident factors, the informing, consultation, balanced 
participation  in  accordance  with  national  laws  and/or  practices  and  training  of  workers 
and their representatives, as well as general guidelines for the implementation of the said 
principles. 

99 

 
 
 
 
The  Framework  Directive  applies  to  all  sectors  of  activity,  both  public  and  private.  It 
establishes  in  particular  the  duty  of  the  employer  to  ensure  the  safety  and  health  of 
workers in every aspect related to the work. It requires the employer to take the measures 
necessary  for  the  safety  and  health  protection  of  workers,  including  prevention  of 
occupational risks and to implement these measures on the basis of general principles of 
prevention, among which 'avoiding risks', 'evaluating the risks which cannot be avoided', 
'combating the risks at source' and 'replacing the dangerous by the non-dangerous or the 
less dangerous'. 

15.1.2  Directive 98/24/EC 

The Directive lays down minimum requirements for the protection of workers from the 
risks  to  their  safety  and  health  arising,  or  likely  to  arise,  from  the  effects  of  chemical 
agents  that  are  present  at  the  workplace  or  as  a  result  of  any  work  activity  involving 
chemical agents. 

The  Directive  provides  for  the  drawing  up  of  indicative  occupational  exposure  limit 
values  (IOELs)  and  binding  occupational  exposure  limit  values  (OELs)  as  well  as 
binding biological limit values (BBLVs) at EU level.193 

For  any  chemical  agent  for  which  an  IOEL  is  established  at  EU  level,  Member  States 
must  establish  a  national  occupational  exposure  limit  value  (OEL),  taking  into  account 
the  EU  limit  value.  Along  the  same  lines,  OELs  and  BBLVs  may  be  drawn  up  at  EU 
level taking into account feasibility factors. For any chemical agent for which a OEL or a 
BBLV is established at EU level, Member States must establish a corresponding national 
binding OEL or a binding BLV that does not exceed the EU limit value. 

The employer must determine whether any hazardous chemical agents are present at the 
workplace and assess any risk to the safety and health arising from their presence. 

The  employer  must  take  the  necessary  preventive  measures  set  out  in  Article  6  of 
Directive 89/391/EEC and risks must be eliminated or reduced to a minimum following 
the hierarchy of prevention measures, among which substitution (replacing a hazardous 
chemical  agent  with  a  chemical  agent  or  process  which  is  not  hazardous  or  less 
hazardous)  must  by  preference  be  undertaken,  whereas  wearing  personal  protective 
equipment is the least preferred option. 

In addition to the above mentioned requirements, which are most relevant for this topic, 
the employer must also take other preventive and protective measures on a regular basis 
(e.g.  health  surveillance  of  workers,  training  of  workers).  The  competent  authorities  of 
the Member States have the obligation to ensure compliance with these requirements. 

The Directive has been implemented into national law in all Member States. 

15.1.3  Directive 2004/37/EC 

Directive  2004/37/EC  requires  eliminating  or  reducing  to  a  minimum  the  risks  arising 
from  the  occupational  exposure  to  carcinogenic  or  mutagenic  chemical  agents  and 
mixtures.  In  order  to  further  reduce  the  occupational  exposure  to  these  particular 
hazardous  chemical  agents  /  mixtures,  the  Directive  lays  down  specific  requirements, 

193 The distinction between IOELs, on the one hand, and BOELs and BBLVs, on the other hand, lies in the 
methods used for their derivation: while IOELs are purely health based, BOELs and BBLVs are drawn 
up  also  taking  into  account  feasibility  or  workability  factors.  IOELs  constitute  thresholds  of  adverse 
health effects and therefore exposure below these limit values should not, in theory, result in a risk for 
the workers’ health 

100 

 
                                                 
which  go  beyond  the  preventive  and  protective  measures  foreseen  in  the  Framework 
Directive 89/391/EEC and the Chemical Agents Directive 98/24/EC. 

Whether a chemical agent or  a mixture is  under the scope of the Directive is  primarily 
based on their classification as a carcinogen or a mutagen (category 1A or 1B) according 
to the criteria established under the CLP Regulation). 

However, there is also a possibility to bring a chemical agent / mixture under the scope 
of the Directive, by including it in Annex I to the Directive. This Annex covers chemical 
agents,  mixtures  or  processes  (or  chemical  agents  /  mixtures  released  by  a  process 
referred to in that Annex) – so-called process-generated chemical agents or PGSs - which 
are not classified according to the CLP Regulation as carcinogens or mutagens, but are 
recognised  by  other  international  bodies  (like  IARC)  as  chemical  agents,  mixtures  or 
processes of equal concern. 

The Directive has been implemented into national law in all Member States. 

15.1.4  Directive 2009/148/EC 

Directive 2009/148/EC applies to activities in which workers are or may be exposed in 
the course of their work to dust arising from asbestos or materials containing asbestos. 

It requires in particular that a risk assessment be carried out by employers ‘in the case of 
any activity likely to involve a risk of exposure to dust arising from asbestos or materials 
containing  asbestos’  and  in  such  a  way  as  to  determine  the  nature  and  degree  of 
exposure. Depending on the initial risk assessment, the asbestos fibres in the air are to be 
measured regularly. Employers must ensure that exposure is reduced to a minimum via 
the adoption of several risk management measures and in any case below the limit value 
of 0,1 fibres per cm 3 as an 8-hour time-weighted average. The Directive also establishes 
specific  obligations  regarding  the  information,  training  and  health  surveillance  of 
workers  and  contains  specific  requirements  as  regards  demolition,  asbestos  removal 
work, repairing and maintenance. 

The  provisions  of  Directive  2004/37/EC  apply  as  regards  asbestos  whenever  they  are 
more  favourable  to  health  and  safety  at  work.  All  Member  States  have  transposed  this 
Directive. 

15.2  Internal Market legislation 

15.2.1  REACH Regulation 

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. 

It  requires  all  companies  manufacturing  and/or  importing  chemicals  into  the  EU  in 
quantities  of  one  tonne  or  more  per  year  to  register  this  chemical  with  the  European 
Chemical  Agency  (ECHA)  in  Helsinki,  to  evaluate  the  risks  resulting  from  the  use  of 
those chemicals and to take the necessary steps to manage any identified risk to human 
health  and  the  environment.  Industry  has  the  burden  of  proving  that  chemicals 
manufactured and placed on the EU market are safe. 

'Restriction' is the procedure via which the manufacture, use and/or placing on the market 
of the chemical is subject to a restriction. A Member State, or ECHA on request of the 
European  Commission,  can  propose  restrictions  if  they  find  that  an  unacceptable  risk 
needs to be addressed on EU wide basis. 

'Authorisation'  aims  to  ensure  that  the  risk  from  a  'Substance  of  Very  High  Concern' 
(SVHC)  is  properly  controlled  and  that  these  chemicals  are  progressively  replaced  by 
less  hazardous  suitable  alternatives.  SVHC  are  amongst  others  chemical  agents  which 
meet  the  criteria  for  classification  as  carcinogenic,  mutagenic  or  toxic  to  reproduction, 

101 

 
Category 1A or 1B according to the CLP Regulation. Chemicals subject to authorisation 
cannot  any  longer  be  placed  on  the  market  or  used  after  certain  date,  unless  an 
authorisation is granted for their specific use, or the use is exempted from authorisation. 
In order to receive an authorisation, manufacturers, importers or downstream users have 
to apply for authorisation if they want to use the chemical agent after the aforementioned 
date. 

REACH  status  of  the  chemical  agents  under  consideration  in  the  present  proposal  is 
presented in the table below. 

Table 1. REACH status of the chemical agents in the present proposal. 

Chemical Agent 

REACH status 

Ethylene dichloride (EDC) 
MDA 
Trichloroethylene (TCE) 
Benzo[a]pyrene 

subject to authorisation 
subject to authorisation 
subject to authorisation 
subject  to  restriction  (as  part  of  the  group  entry  50  of 
Annex XVII for  eight PAHs). 
Identified as a SVHC. 

15.2.2  CLP Regulation 

The  CLP  Regulation  (for 
'Classification,  Labelling  and  Packaging')  is  the  EU 
Regulations  which  aligns  the  previous  EU  system  of  classification,  labelling  and 
packaging of chemical agents and mixtures to the UN Globally Harmonized System. It 
complements the REACH Regulation and replaces the current system. 

The  regulation  requires  companies  to  appropriately  classify,  label  and  package  their 
chemical  agents  and  mixtures  before  placing  them  on  the  market.  It  aims  to  protect 
workers,  consumers  and  the environment  by  means  of  labelling  which reflects  possible 
hazardous effects of a particular chemical. 

Five  OSH  Directives  (CAD,  CMD,  Pregnant  Workers  Directive,  Young  Workers 
Directive, Safety Signs at Work Directive194) are directly related to the CLP Regulation 
by  providing  a  link  to  the  hazard  classification  of  chemical  agents  and  mixtures 
according to the CLP Regulation, and the resulting obligations for employers under the 
OSH  Directives  (e.g.  chemical  agents  and  mixtures  classified  as  carcinogens  or 
mutagens, category 1A or 1B are under the scope of the CMD). 

15.2.3  Comparison  of  high  level  CMD  and  REACH  provisions  in  relation  to 

occupational carcinogens 

CMD 

REACH 

Scope includes process-generated chemical 
agents 

Scope  does  not  include  process-generated 
chemical agents 

Sets  'minimum  standards'.  Member  States 
implement  more 
may  maintain 

or 

Sets  directly-acting  harmonised  standards 
from  which  Member  States  cannot  deviate 

194 Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety 
and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive 
89/391/EEC) (OJ L 245, 26.8.1992, p. 23 

102 

 
 
                                                 
protective measures. 

Risk assessment is, in all cases, specific to 
the  workplace  where  exposures  occur 
taking into account any specific processes, 
operating 
workforce 
conditions, 
characteristics, etc. 

Risk  assessment 
into  account 
aggregated  exposure  of  workers  to  all 
carcinogens at workplace level. 

takes 

EU  OEL  applies  only  in  workplaces,  and 
so 
targeted  solely  at  occupational 
is 
exposures. 

carcinogens  must 

Occupational 
be 
substituted  by  a  safer  alternative  where 
technically possible, then exposure must be 
eliminated  where  technically  possible  or 
otherwise  minimised.  An  EU  OEL  for  a 
given  carcinogen  does  not  alter 
this 
expectation, but provides a compliance and 
enforcement  benchmark  for  employers, 
workers and enforcers. 

As  social  policy,  under  TFEU  the  social 
partners  play  a  key  role  in  establishing 
for  worker  protection  by 
standards 
adopting  agreed  positions  on  which 
chemical agents should be made subject to 
EU  level  OELs,  at  what  level,  and  with 
additional commentary where appropriate. 

except  in  exceptional  (and  possibly  time 
limited) circumstances. 

Risk  assessment  for  majority  of  chemical 
substances  is  undertaken  by  actors  in  the 
(primarily  manufacturers 
supply  chain 
and/or  importers).  May  be  specific  to 
specific  workplace/s  or  more  generic 
applying to a larger number of workplaces. 

assessed 

identified 

Risks 
risk 
and 
management  measures  are  specific  to  the 
chemical  substance  or  mixture  being 
manufactured,  used  and  placed  on  the 
market. REACH should result in improved 
information  being  provided  down 
the 
supply  chain  to  employers  to  inform  their 
OSH risk assessment. 

REACH covers all risks arising from given 
intrinsic  properties  of  a  substance  which 
are  not  made 
specific 
derogations.  These  may  include  risks  for 
workers,  the  public,  consumers,  and  the 
environment. 

subject 

to 

REACH can complement  a CMD  OEL, in 
particular by strengthening the substitution 
principle and its full implementation. 

As  an  internal  market  Regulation  social 
partners  have  no  formal  role  according  to 
the  TFEU  in  policy  or  development  of 
legal  standards.  However,  all  stakeholders 
are invited to provide comments during the 
established public consultations. 

OELs  are  established  under  and  are  an 
important part of CMD. 

REACH is not intended to set OELs. 

103 

 
 
 
 
16  ANNEX  9  –  GENERAL  INFORMATION  ABOUT  THE  CLASSIFICATION  SYSTEMS 

REFERRED TO IN THE DOCUMENT 

16.1  Carcinogens 

In this report, reference is mainly made to 2 systems to classify 'agents' as carcinogens or 
carcinogenic:  

 

 

The  EU  classification,  packaging  and  labelling  system  based  on  the  CLP 
Regulation (EC) No 1272/2008; 

The  classification  system  of  the  International  Agency  for  Research  on  Cancer 
(IARC) 

16.1.1  Classification according to the CLP Regulation 
The  harmonised  classification195  of  a  chemical  agent  listed  in  Annex  I  to  the  CLP 
Regulation  and  the  resulting  /  associated  labelling  and  packaging  provisions  is  legally 
binding  for  suppliers  placing  a  chemical  agent  on  the  European  market.  An  entry  in 
Annex  I  is  established  by  the  Commission  via  an  amendment  of  the  CLP  Regulation, 
following  a  scientific  evaluation  of  the  available  information  by  the  Risk  Assessment 
Committee of the European Chemicals Agency (ECHA). If a chemical agent is not listed 
in Annex VI of the Regulation, suppliers must self-classify its chemical agent according 
to  the  criteria  established  under  the  CLP  Regulation  before  placing  it  on  the  market. 
Following Article 2 ('Definitions') of the CLP Regulation, a 'chemical agent' is means 'a 
chemical  element  and  its  compounds  in  the  natural  state  or  obtained  by  any 
manufacturing process, including any additive necessary to preserve its stability and any 
impurity  deriving  from  the  process  used,  but  excluding  any  solvent  which  may  be 
separated  without  affecting  the  stability  of  the  chemical  agent  or  changing  its 
composition'. 

Mixtures  (composed  of  two  or  more  chemical  agents)  are  classified,  labelled  and 
packaged based on the content of their classified components ('chemical agents') or based 
on  test  results  for  the  mixture  as  a  whole  following  again  the  classification  criteria 
established under the CLP Regulation. 

The  exact  criteria  to  classify  chemical  agents  and  mixtures  according  to  the  CLP 
Regulation  can  be  found  in  section  3.6  of  that  Regulation196.  For  the  purpose  of  this 
report  it  is  important  to  notice,  that  the  CMD  applies  'only'  to  chemical  agents  and 
mixtures meeting the criteria for classification as category 1A or 1B carcinogens set out 
in Annex I to the CLP Regulation. 

 

 

Category  1A  carcinogens  are  chemical  agents  known  to  have  carcinogenic 
potential for humans; their classification is largely based on human evidence (so-
called epidemiological evidence) 

Category  1B  carcinogens  are  chemical  agents  presumed  to  have  carcinogenic 
potential for humans; their classification is largely based on animal evidence. 

Suspected human carcinogens (Category 2 carcinogens according to the CLP Regulation) 
are not under the scope of the CMD. 

195 classification of chemical agents listed in Annex VI to the Regulation 
196 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R1272-

20150601&qid=1447160631531&from=EN  

104 

 
                                                 
16.1.2  Classification according to IARC 

The  evaluations  of  carcinogenic  risk  are  made  by  international  working  groups  of 
independent  scientists  and  are  qualitative in  nature,  and  is published  in  the  form  of  so-
called Monographs available on the IARC website197. Contrary to the EU system, IARC 
evaluates also the carcinogenicity of occupational or environmental exposures, cultural or 
behavioural practices, biological organisms and physical agents. 
Even if the IARC approach is - like the EU approach - also hazard and not risk based198, 
it  goes  beyond  the  chemical  agent  based  approach  of  the  EU  by  evaluating  not  only 
chemical  agents  but  also  certain  occupational  exposure  situations  (for  example 
'Occupational  Exposures  in  the  Rubber  Manufacturing  Industry'  or  'Occupational 
Exposure as a Painter'199). 

Based  on  its  evaluation,  IARC  classifies  'agents'  in  5  groups  with  regard  to  their 
carcinogenicity to humans200: 

 

 

 

 

 

Group 1 – The agent is carcinogenic to humans / This category is used when there 
is sufficient evidence of carcinogenicity in humans. 

Group 2A – The agent is probably carcinogenic to humans / This category is used 
when there is limited evidence of carcinogenicity in humans and sufficient evidence 
of carcinogenicity in experimental animals. 

Group 2B – The agent is possibly carcinogenic to humans / This category is used 
for agents for which there is limited evidence of carcinogenicity in humans and less 
than sufficient evidence of carcinogenicity in experimental animals.201 

Group 3 – The agent is not classifiable as to its carcinogenicity to humans / This 
category  is  used  most  commonly  for  agents  for  which  the  evidence  of 
carcinogenicity is inadequate in humans and inadequate or limited in experimental 
animals. 

Group 4 – The agent is probably not carcinogenic to humans / This category is used 
for agents for which there is evidence suggesting lack of carcinogenicity in humans 
and in experimental animals. 

197 http://monographs.iarc.fr/ENG/Monographs/PDFs/index.php  
198 A hazard is any source of potential damage, harm or adverse health effects on something or someone 
under  certain  conditions  at  work;  the  isk  is  the  chance  or  probability  that  a  person  will  be  harmed  or 
experience an adverse health effect if exposed to a hazard. 
199 http://monographs.iarc.fr/ENG/Monographs/vol100F/index.php 
200 The details of the objectives and scope of the IARC Monographs programme, the scientific principles 
and the procedures used in developing a Monograph, the types of evidence considered and the scientific 
criteria guiding the evaluations can be found in the preamble of each Monograph and on the following 
web side: http://monographs.iarc.fr/ENG/Preamble/index.php 

201 The  terms  probably  carcinogenic  and  possibly  carcinogenic  have  no  quantitative  significance  and  are 
used  simply  as  descriptors  of  different  levels  of  evidence  of  human  carcinogenicity,  with  probably 
carcinogenic signifying a higher level of evidence than possibly carcinogenic. 

105 

 
 
 
                                                 
17  ANNEX 10 – ADDITIONAL GRAPHICAL MATERIAL 

Graphs are provided only where data is available in IOM Study 

17.1  Epichlorohydrine 

Figure 3 – Epichlorohydrine - Current national OELs vs. Option 2 

Figure 4 - Epichlorohydrine – Number of exposed workers 

106 

 
 
 
 
 
17.2  Ethylene dibromide 

Figure 5 – Ethylene dibromide – Current national OELs vs. Option 2 

Figure 6 – Ethylene dibromide - Number of exposed workers 

107 

 
 
 
 
 
17.3  Ethylene dichloride 

Figure 7 – Ethylene dichloride - Current national OELs vs. Option 2 

108 

 
 
 
 
17.4  4,4,'Methylenedianiline 

Figure 8 – 4,4,'Methylenedianiline - Current national OELs vs. Option 2 

Figure 9 – 4,4,'Methylenedianiline - Number of exposed workers 

109 

 
 
 
 
 
17.5  Trichlorothylene 

Figure 10 – Trichlorothylene - Current national 8 hr TWA OELs vs. Option 2 

600

mg/m3 

500

400

300

200

100

0

T
A

E
B

G
B

Y
C

Z
C

E
D

K
D

E
E

L
E

S
E

I
F

R
F

R
H

U
H

E
I

T
I

T
L

U
L

V
L

T
M

L
N

L
P

T
P

O
R

E
S

I
S

K
S

K
U

 Trichloroethylene- national OELs

Option 2

Figure 11 – Trichlorothylene - Current national 15 min STEL-OELs vs. EU OEL and Option 2 

110 

 
 
 
 
 
Figure 12– Trichlorothylene - Number of exposed workers 

17.6  Complex PAH mixtures with benzo[a]pyrene as an indicator 

Figure  13  –  Complex  PAH  mixtures  with  benzo[a]pyrene  as  an  indicator  -  Number  of  exposed 
workers 

111 

 
 
 
 
 
17.7  Mineral Oils as Used Engine Oils 

Figure 14 – Mineral Oils as Used Engine Oils - Number of exposed workers 

18  ANNEX 11 – ABBREVIATIONS USED 

ACSH 

Advisory Committee on Safety and Health at Work 

BAP 

Be 

BGV 

BLV 

Benzo[a]pyrene 

Beryllium 

Biological Guidance Value 

Biological Limit Value 

BIOLOGICAL MONITORING VALUE  Biological Monitoring Value 

CAD 

CBD 

CLP 

CMD 

CMR 

DEE 

DNEL 

ECHA 

EDB 

EDC 

EIG 

ECH 

Chemical Agents Directive (Directive 98/24/EC) 

Chronic Beryllium Disease 

Classification,  Labelling  and  Packaging  Regulation  (Regulation  (EC)  No 
1272/2008) 

Carcinogens and Mutagens Directive (Directive 2004/37/EC) 

carcinogenic, mutagenic, and chemical agents toxic to reproduction 

Diesel engine exhaust 

Derived No Effect Level 

European Chemicals Agency 

Ethylene dibromide 

Ethylene dichloride 

Employers Interest Group 

Epichlorohydrine 

112 

 
 
GIG 

HCB 

IARC 

Government Interest group 

Hexachlorobenzene 

International Agency for Research on Cancer 

MOCA 

4,4'-Methylene-bis-(2-chloroaniline) 

MDA 
mg/m3 

MOs 

NEPSi 

OEL 

OSH 

PGSs 

ppm 

RAC 

RCF 

RCS 

REACH 

REFIT 

RPDF 

4,4'-Methylenedianiline 

milligram per cubic metre 

Mineral oils 

Agreement  on  Workers'  Health  Protection  Through  the  Good  Handling 
and Use of Crystalline Silicas and Products Containing it 

Occupational Exposure Limit (Value) 

Occupational Safety and Health 

Process Generated Substances 

parts per million 

Risk assessment Committee of ECHA 

Refractory Ceramic Fibres 

Respirable Crystalline Silica 

Regulation  on  Registration,  Evaluation,  Authorisation  and  Restriction  of 
Chemicals (Regulation (EC) No 1907/2006) 

Regulatory Fitness and Performance Programme 

Rubber Process Dust and Fumes 

SCOEL 

Scientific Committee on Occupational Exposure Limits 

SMEs 

STEL 

SWD 

SVHC 

TFEU 

TCE 

TWA 

UEOs 

UN 

VCM 

YYL 

WIG 

WHO 

WPC 

Small and Medium Sized Enterprises 

Short Term Exposure Limit 

Staff Working Document 

 Substance of Very High Concern 

Treaty on the Functioning of the EU 

Trichloroethylene 

Time-weighted average 

Mineral Oils as Used Engine Oils 

United Nations 

Vinyl Chloride Monomer 

Years of Life Lost 

Workers Interest Group 

World Health Organisation 

Working Party 'Chemicals at the Workplace' 

113