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: 2016-05-13
Institutions: Directorate-General for Employment, Social Affairs and Inclusion, European Commission
Subjects: cancer, carcinogenic substance, health risk, occupational disease, occupational health, safety standard

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 13.5.2016  SWD(2016) 152 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(2016) 248 final} {SWD(2016) 153 final}  
 
 
TABLE OF CONTENTS 

INTRODUCTION ............................................................................................................... 7 

1  WHAT IS THE PROBLEM AND WHY IS IT A PROBLEM? ................................. 8 

1.1.1 
1.1.2 
1.1.3 

1.1  Main drivers ....................................................................................................... 9 
Exposure of workers to carcinogens is significant .............................. 9 
The Carcinogens and Mutagens Directive is outdated ...................... 10 
Inadequate  OELs  at  MS  level  have  negative  consequences  for 
workers and businesses across the EU .............................................. 16 
1.2  Who is affected by the problem and how? ...................................................... 17 
1.3  How would the problem evolve? ..................................................................... 19 

2  WHY SHOULD THE EU ACT? .............................................................................. 21 

2.1  Does the EU have the right to act? .................................................................. 21 
2.2  Why is EU action needed and what is its added value? .................................. 21 
2.3  What  are  the  EU  instruments  relevant  to  dealing  with  carcinogens  at  the 
workplace? ....................................................................................................... 22 
2.4  How does this initiative relate to the envisaged review of the OSH acquis? .. 24 

3  WHAT SHOULD BE ACHIEVED? ........................................................................ 25 

3.1  What  are  the  general  policy  objectives?  What  are  the  more  specific 
objectives? ....................................................................................................... 25 
3.2  Are  these  objectives  consistent  with  other  EU  policies  and  with  the  Charter 
for fundamental rights? .................................................................................... 26 

4  WHAT ARE THE VARIOUS OPTIONS TO ACHIEVE THE OBJECTIVES? ..... 26 

4.1  Complementary measures ............................................................................... 26 
4.2  Discarded options ............................................................................................ 27 
4.3  Options retained for consideration .................................................................. 30 

5  WHAT  ARE  THE  IMPACTS  OF  THE  DIFFERENT  POLICY  OPTIONS  AND 
HOW DO THEY COMPARE? ................................................................................. 34 

1,2 Epoxypropane ............................................................................................ 37 
5.1 
1,3 Butadiene ................................................................................................... 39 
5.2 
5.3 
2 Nitropropane ................................................................................................. 42 
5.4  Acrylamide ...................................................................................................... 44 
5.5  Hardwood dust ................................................................................................. 46 
5.6  Chromium (VI) compounds ............................................................................ 49 
5.7  Ethylene oxide (EO) ........................................................................................ 56 
5.8 
o-Toluidine ...................................................................................................... 58 
5.9  Refractory Ceramic Fibres (RCF) ................................................................... 61 
5.10  Respirable Crystalline Silica ........................................................................... 63 
5.11  Vinyl Chloride Monomer (VCM) ................................................................... 70 
5.12  Bromoethylene (vinyl bromide) ...................................................................... 72 

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5.13  Hydrazine ........................................................................................................ 74 
5.14  Summary of the retained options ..................................................................... 77 

6  OVERALL IMPACT OF THE PACKAGE OF RETAINED OPTIONS ................ 78 

6.1 
6.2 

Impact on workers ........................................................................................... 78 
Impact on businesses ....................................................................................... 80 
Impact on SMEs ................................................................................ 81 
6.2.1 
Impact on competition and competitiveness ..................................... 82 
6.2.2 
Impact on Member States/national authorities ................................................ 83 
6.3 
6.4 
Impact on fundamental rights .......................................................................... 83 
6.5  How  does  the  retained  option  conform  to  the  principles  of  subsidiarity  and 
proportionality given the size and nature of the identified problem? .............. 84 

7  HOW WOULD ACTUAL IMPACTS BE MONITORED AND EVALUATED? .. 84 

7.1  Monitoring arrangements ................................................................................ 84 
7.2  Evaluation arrangements ................................................................................. 85 

ANNEXES ........................................................................................................................ 87 

8  ANNEX 1 – PROCEDURAL INFORMATION ...................................................... 87 

8.3.1 

8.1  Lead DG .......................................................................................................... 87 
8.2  Consultation of the Regulatory Scrutiny Board (RSB) ................................... 87 
8.3  Evidence used in the impact assessment ......................................................... 89 
IARC Monographs ............................................................................ 89 
8.4  External expertise ............................................................................................ 90 
8.4.1  Use of scientific expertise / Commission expert groups / SCOEL ... 90 
Studies performed by external consultants ........................................ 90 
8.4.2 
Study on chemical agents toxic to reproduction ................................ 91 
8.4.3 

9  ANNEX 2 - STAKEHOLDER CONSULTATION .................................................. 92 

9.2.1 
9.2.2 

9.1  Social partner Consultation ............................................................................. 92 
9.2  Other consultation of stakeholders .................................................................. 94 
25 October 2006 - Workshop of setting OELs for Carcinogens ....... 94 
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) 94 
9.2.3  Consultation  of  the  tripartite  Working  Party  "Chemicals  at  the 
Workplace" (WPCs) of the ACSH .................................................... 95 
9.2.4 
September 2012 - Workshop in Berlin .............................................. 96 
9.2.5  Consultation  of  the  members  of  the  ACSH  on  existing  national 
OELs for chemical agents subject to the amendments ...................... 96 
9.2.6  Meetings with Industry and Workers representatives ....................... 97 

10  ANNEX 3 – WHO IS AFFECTED BY THE INITIATIVE AND HOW? ............... 98 

11  ANNEX  4  –  ANALYTICAL  MODEL  USED  IN  PREPARING  THE  IMPACT 
ASSESSMENT ....................................................................................................... 100 

11.1  Exposure estimation ...................................................................................... 100 

3 

 
11.2  Health  impact  –  methodology  for  estimation  of  the  current  cancer  burden 
(baseline) as compared with the policy intervention scenarios ..................... 101 
11.3  Compliance costs ........................................................................................... 109 

12  ANNEX  5  –  DETAILED  INFORMATION  ON  THE  CARCINOGENICITY  OF 
THE CHEMICAL AGENTS ................................................................................... 110 

12.1  Respirable crystalline silica ........................................................................... 110 
12.1.1 
Identification .................................................................................... 110 
12.1.2  Synonyms ........................................................................................ 110 
12.1.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity: ................................................................ 111 
12.1.4  Classification according to IARC .................................................... 111 
12.1.5  Recommendation of SCOEL ........................................................... 111 
12.2  Refractory ceramic fibres (RCFs) ................................................................. 112 
Identification .................................................................................... 112 
12.2.1 
12.2.2  Synonyms ........................................................................................ 112 
12.2.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity ................................................................. 112 
12.2.4  Classification according to IARC .................................................... 113 
12.2.5  Recommendation of SCOEL ........................................................... 113 
12.3  Acrylamide .................................................................................................... 114 
12.3.1 
Identification .................................................................................... 114 
12.3.2  Synonyms ........................................................................................ 114 
12.3.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity: ................................................................ 114 
12.3.4  Classification according to IARC .................................................... 114 
12.3.5  Recommendation of SCOEL ........................................................... 114 
12.4  Vinyl chloride monomer ................................................................................ 116 
12.4.1 
Identification .................................................................................... 116 
12.4.2  Synonyms: ....................................................................................... 116 
12.4.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity: ................................................................ 116 
12.4.4  Classification according to IARC .................................................... 116 
12.4.5  Conclusions of SCOEL ................................................................... 116 
12.5  Hardwood dust ............................................................................................... 117 
Identification .................................................................................... 117 
12.5.1 
12.5.2  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity: ................................................................ 117 
12.5.3  Synonyms ........................................................................................ 117 
12.5.4  Classification according to IARC .................................................... 117 
12.5.5  Recommendations of SCOEL ......................................................... 117 
12.6  Chromium (VI) compounds .......................................................................... 118 
12.6.1 
Identification .................................................................................... 118 
12.6.2  Synonyms ........................................................................................ 119 

4 

 
12.6.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity ................................................................. 119 
12.6.4  Classification according to IARC .................................................... 119 
12.6.5  Conclusion of SCOEL ..................................................................... 119 
12.7  1-3- butadiene ................................................................................................ 123 
12.7.1 
Identification .................................................................................... 123 
12.7.2  Synonyms ........................................................................................ 123 
12.7.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity ................................................................. 123 
12.7.4  Classification according to IARC .................................................... 123 
12.7.5  Recommendation of SCOEL ........................................................... 124 
12.8  Ethylene oxide ............................................................................................... 124 
12.8.1 
Identification .................................................................................... 124 
12.8.2  Synonyms ........................................................................................ 124 
12.8.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity ................................................................. 124 
12.8.4  Classification according to IARC .................................................... 125 
12.8.5  Conclusion of SCOEL ..................................................................... 125 
12.9  1,2 Epoxypropane .......................................................................................... 126 
Identification .................................................................................... 126 
12.9.1 
12.9.2  Synonyms ........................................................................................ 127 
12.9.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity ................................................................. 127 
12.9.4  Classification according to IARC .................................................... 127 
12.9.5  Conclusion of SCOEL ..................................................................... 127 
12.10 o-Toluidine .................................................................................................... 128 
12.10.1  Identification .................................................................................... 128 
12.10.2  Synonyms ........................................................................................ 129 
12.10.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity ................................................................. 129 
12.10.4  Classification according to IARC .................................................... 129 
12.10.5  Conclusion of SCOEL ..................................................................... 129 
12.11 2 Nitropropane ............................................................................................... 129 
12.11.1  Identification .................................................................................... 129 
12.11.2  Synonyms ........................................................................................ 129 
12.11.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity ................................................................. 129 
12.11.4  Classification according to IARC .................................................... 129 
12.11.5  Conclusion of SCOEL ..................................................................... 129 
12.12 Bromoethylene .............................................................................................. 129 
12.12.1  Identification .................................................................................... 129 
12.12.2  Synonyms ........................................................................................ 129 
12.12.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity ................................................................. 130 

5 

 
12.12.4  Classification according to IARC .................................................... 130 
12.12.5  Conclusion of SCOEL ..................................................................... 130 
12.13 Hydrazine ...................................................................................................... 130 
12.13.1  Identification .................................................................................... 130 
12.13.2  Synonyms ........................................................................................ 130 
12.13.3  Classification  according  to  Regulation  (EC)  N°  1272/2008  with 
regard to carcinogenicity ................................................................. 131 
12.13.4  Classification according to IARC .................................................... 131 
12.13.5  Conclusion of SCOEL ..................................................................... 131 

13  ANNEX  6  -  EXPOSURE  LIMIT  VALUES  IN  EU  MEMBER  STATES  AND 
SOME NON-EU COUNTRIES .............................................................................. 133 

14  ANNEX 7 - RELEVANT EU LEGISLATION ...................................................... 139 

14.1  Existing EU-OSH framework ........................................................................ 139 
14.1.1  Directive 89/391/EEC ..................................................................... 139 
14.1.2  Directive 98/24/EC .......................................................................... 139 
14.1.3  Directive 2004/37/EC ...................................................................... 140 
14.1.4  Directive 2009/148/EC .................................................................... 140 
14.2  Internal Market legislation ............................................................................ 140 
14.2.1  REACH Regulation ......................................................................... 140 
14.2.2  CLP Regulation ............................................................................... 142 
14.2.3  Comparison  of  high  level  CMD  and  REACH  provisions  in  relation 
to occupational carcinogens ............................................................ 143 

15  ANNEX  8  –  GENERAL  INFORMATION  ABOUT  THE  CLASSIFICATION 
SYSTEMS REFERRED TO IN THE DOCUMENT .............................................. 145 

15.1  Carcinogens ................................................................................................... 145 
15.1.1  Classification according to the CLP Regulation ............................. 145 
15.1.2  Classification according to IARC .................................................... 146 

16  ANNEX 9 – ADDITIONAL GRAPHICAL MATERIAL ...................................... 147 

16.1  1,2 Epoxypropane .......................................................................................... 147 
16.2  1,3 Butadiene ................................................................................................. 147 
16.3  2 Nitropropane ............................................................................................... 148 
16.4  Acrylamide .................................................................................................... 149 
16.5  Hardwood dust ............................................................................................... 151 
16.6  Chromium VI ................................................................................................. 152 
16.7  Ethylene oxide ............................................................................................... 153 
16.8  o-Toluidine .................................................................................................... 155 
16.9  Refractory Ceramic Fibres (RCF) ................................................................. 156 
16.10 Respirable Crystalline Silica (RCS) .............................................................. 156 
16.11 Vinyl Chloride Monomer (VCM) ................................................................. 158 
16.12 Bromoethylene (vinyl bromide) .................................................................... 158 
16.13 Hydrazine ...................................................................................................... 159 

17  ANNEX 10 – ABBREVIATIONS USED .............................................................. 160 

6 

 
INTRODUCTION 

Exposure to some chemical agents in the workplace can cause cancer. To ensure that workers 
are  protected  against  such  risks,  the  EU  has  adopted  the  Carcinogens  and  Mutagens  Directive 
(CMD)1. The Directive sets out steps to be taken to eliminate or limit exposure to carcinogenic 
chemical agents. It establishes under Article 16 that the Council shall set out limit values over 
which exposure is not allowed, on the basis of available scientific and technical data, in respect 
of all those carcinogens for which this is possible. 

The limit values create useful benchmarks for employers and enforcement authorities to decide 
on which protection measures should be taken. This adds to the general obligation in the CMD 
for  employers  to  eliminate  exposure  of  workers  to  carcinogenic  substances  and  makes  more 
explicit  the  general  requirement  of  the  over-arching  Occupational  Safety  Health  (OSH) 
Framework Directive2 to eliminate all risks. 

In order to fulfil the obligation under Article 16 of the Directive to set limit values in respect of 
all  those  carcinogens  for  which  this  is  possible,  the  Commission  has  initiated  a  scientific  and 
economic assessment of 25 priority chemical agents which have been classified as carcinogens 
by national and/or international authorities and institutions. In the EU around 20 million workers 
are  exposed  to  at  least  one  of  these  chemical  agents.  Following  discussions  by  scientists, 
employers, workers, Member States' representatives and labour inspectors in a series of health 
and safety committees, suggestions for limit values have been developed. 

Introducing  these  limit  values  in  the  Directive  would  provide  employers,  workers  and 
enforcement bodies with an objective measure to help to ensure that the general principles of the 
Directive are complied with. This should contribute to a reduction in exposure to these priority 
carcinogens with a consequential reduction in potential new cases of occupational cancer in the 
affected workers. It is estimated that under the baseline the considered carcinogens will lead to 
over 460,000 deaths caused by occupational exposure. Introduction of the proposed limit values 
could  make  it  possible  to  avoid  some  100,000  of  them  in  the  forthcoming  50  years3.  These 
figures are based on estimations made in a study contracted by the Commission4. 

In certain cases introduction of limit values would impose some costs on enterprises to take the 
necessary  protective  measures  such  as  installing  ventilation  systems  and  acquiring  protective 
equipment where they do not exist. On the other hand, establishing compliance benchmarks for 
exposure  control  through  these  limit  values  would  mean  that  businesses  have  clear  minimum 
standards applied across the internal market. 

The calculations underpinning the analysis of costs and benefit for limit values are complicated 
due  to  a  number  of  factors,  not  least  that  the  time  between  exposure  to  a  carcinogen  and  the 
onset of the disease can be up to 50 years. Calculating costs and benefits over such a long period 
is challenging and based on a number of assumptions regarding gradually reduced exposure in 
the baseline, production methods, medical knowledge etc. 

1  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) 

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. 

3   Deaths avoided mainly in relation to the following chemical agents: Chromium VI - 1670; Refractory Ceramic 
Fibres - 50; Respirable Crystalline Silica - 98,670. The analytical model used to arrive at these figures can be 
found in Annex 4. 

4  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. 

7 

 
                                                 
This impact assessment looks at the costs and benefits of introducing limit values for 13 of the 
25  priority  chemical  agents.  For  the  remaining  chemical  agents  there  is  additional  analysis  of 
costs and benefits to be done. This analysis will be presented in a further impact assessment. 

1  WHAT IS THE PROBLEM AND WHY IS IT A PROBLEM? 

According to the World Health Organisation (WHO), cancer is the second largest cause of death 
in  most  developed countries.5 In  the European Union  in  2013 there were approximately  1.314 
mln  cancer  deaths.  In  2012,  an  estimated  2.7  mln  new  cases  of  cancer  were  diagnosed  in  EU 
Member States6, and 7.2 mln people were living with cancer (within 5 years of diagnosis)7,8. 

Cancer is the first cause of work-related deaths in the EU (see Figure 1 below). 53% of annual 
occupational deaths are attributed to cancer, compared to 28% for circulatory diseases and 6% 
for respiratory diseases. 

The number of deaths attributed to occupational cancer in the EU is reported to be 102,500 for 
20119. 

Figure 1.  Deaths attributed to work 

communicable 
diseases; 2,5% 

other; 4,2% 

mental disorders; 
5,7% 

respiratory 
diseases; 6,0% 

circulatory 
diseases; 28,0% 

Source: WSH Institute 2014 

Cancers; 53,0% 

5  Are the number of cancer cases increasing or decreasing in the world?, World Health Organisation, April 2008 
6  European Commission, Health at a glance 2014. 
7  IARC, cancer fact sheets, http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx 
8  Data for more recent years (2013,2014) are available only for a limited number of Member States,  which does 
not allow compilation of estimates for EU totals (according to Eurostat's guidance an estimate for an EU total 
can be compiled only if the available figures cover 90% of the EU population). 

9  Eliminating  occupational  cancer  in  Europe  and  Globally,  Takala,  J,  European  Trade  Union  Institute,  October 

2015. 

8 

 
 
 
 
 
 
                                                 
Figure 2. Problem tree 

S
R
E
V
I
R
D

M
E
L
B
O
R
P

S
E
C
N
E
U
Q
E
S
N
O
C

Market driver: 

 Exposure of workers to carcinogens is 

significant.  

Regulatory drivers: 

 Outdated EU legal framework for 

carcinogens 

 Inadequate national OELs 

 Cancer is the first cause of work-related deaths 

For businesses: 
 Higher costs 
(absenteeism, staff 
replacement, higher 
wages) 
 Reduced staff 
productivity 
 Distorted competition 

For Member States: 
 Higher social 
security costs 

 Forgone tax 
revenue 

For workers: 
 Reduced quality of 

life  

 Premature deaths 
 Higher health related 

costs 

1.1  Main drivers 

1.1.1  Exposure of workers to carcinogens is significant 

Different forms of cancer may be initiated or promoted by the exposure to carcinogenic and/or 
mutagenic  chemical  agents  at  work10.  In  the  EU  32  mln  workers  (23%  of  people  employed) 
were exposed to chemical agents classified as carcinogenic or probably carcinogenic to humans 
by  the  WHO's  International  Agency  for  Research  on  Cancer  (IARC)  in  1990-93.11  In  France, 
estimates  from  2010  suggest  that  approximately  2  mln  workers  were  exposed  to  at  least  one 
carcinogen  in  their  most  recent  week  of  activity  at  work,  approximately  10%  of  the  working 
population. Workers in maintenance activities (42.6%  exposed) and young workers (below 25 
years  of  age)  (15.2%  exposed)  were  found  to  be  particularly  exposed,  and  many  of  them  to 
several carcinogens, mutagens and reprotoxins at the same time12. 
According  to  the  EU  Classification,  Labelling  and  Packaging  Regulation  (CLP)13,  1017 
chemical  agents  (and  groups  of  chemical  agents)  have  received  mandatory  'harmonised 
classification'  as  'category  1'  carcinogens,  attracting  the  label  hazard  statement  'may  cause 
cancer'. If the assessment was based primarily on human evidence category 1A is assigned (this 

10  Workplace  factors  other  than  chemical  agents  might  contribute  to  development  of  cancers  (e.g.  ultraviolet 
radiation, infections, etc.). The scope of the Carcinogens and Mutagens Directive is however limited to chemical 
agents. 

11  Occupational exposure to carcinogens in the European Union, Kauppinen, T. et al., Occup Environ Med, 2000, 

57: 10-18. 

12  Les  expositions  aux  cancérogènes,  mutagènes  et  reprotoxiques.  Un  zoom  sur  huit  produits  chimiques.  Dares 
2015  (see  https://osha.europa.eu/en/oshnews/fr-over-2-mln-people-exposed-least-one-carcinogen-mutagen-or-
reprotoxicant-2010) 

13  Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on 

classification, labelling and packaging of chemical substances and mixtures 

9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
 
 
 
 
 
 
 
is the case for 336 agents), with category 1B assigned where animal evidence is primarily used 
(681 agents are in this category). Chemicals suspected to cause cancer in humans but where data 
is not sufficiently convincing for category 1 may be classified as 'category 2 carcinogens'. 

IARC has identified nearly 500 agents that are carcinogenic for humans (Group 1; 118 agents), 
probably  carcinogenic  to  humans  (Group  2A;  75)  or  possibly  carcinogenic  to  humans  (Group 
2B; 288).14 

Table  1  in  the  section  1.1.2.  presents  estimates  of  numbers  of  workers  exposed  to  the 
carcinogens  covered  in  this  report.  The  numbers  of  exposed  workers  vary  significantly  across 
the  agents.  Some  of  the  carcinogens,  like  Respirable  Crystalline  Silica  (RCS),  chromium  (VI) 
compounds, hardwood dust or hydrazine, affect very high numbers of workers. For some others 
there  are  indications  that  use  patterns  may  be  lower.  However,  the  agents  are  themselves 
important – for example the ratio between the number of exposed workers and cancer cases may 
be higher for some of these chemical agents. It is also important to recognise that use patterns 
change rapidly and for complex reasons. Market forces such as raw material and energy prices, 
developing technology, as well as regulatory changes can drive increases in use which are not 
easy  to  predict.  This  is  the  case  for  example  for  acrylamide,  used  for  production  of 
polyacrylamide, which is a growing sector. 

1.1.2  The Carcinogens and Mutagens Directive is outdated 

The current rules 

While  cancer  is  a  complex  disease  and  some  causal  factors  are  difficult  to  identify,  it  is  clear 
that cancers caused by work can be prevented by reducing or eliminating the exposures leading 
to the disease. 

The  EU  principles  of  worker  protection  from  carcinogens  are  laid  out  in  the  over-arching 
Occupational  Safety  Health  (OSH)  Framework  Directive  89/391/EEC  and  those  Directives 
specifically dealing  with chemicals risks  – notably  the Chemical Agents Directive (CAD)  and 
the  Carcinogens  and  Mutagens  Directive  (CMD).  The  latter  includes  a  commitment  to  set 
Occupational  Exposure Limit (OELs)  values  for  all carcinogens  or mutagens for which this is 
possible.15 

Under  the  OSH  framework  risks  to  the  safety  and  health  of  workers  shall  be  eliminated  or 
reduced to a minimum. In the case of carcinogens, CMD sets a number of concrete provisions. 

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. 

14  Monographs  on  the  evaluation  of  carcinogenic  risk  to  humans,  International  Agency  for  Research  on  Cancer, 

WHO. 

15  OEL  values  are  stated  as  quantitative  figures  representing  the  airborne  concentration  of  the  chemical  agent  in 
question  as  a  time  weighted  average  over  8  hours.    Concentrations  expressed  as  mg/m3  values  indicate 
milligrams  of  chemical  agent per  cubic  metre  of  air  at 20  °C  and  101,3  kPa (760  mm  mercury pressure).    To 
note,  in  a  strict  sense  when  referring  to  limits  set  in  the  CMD,  the  term  'limit  value'  should  be  used  –  often 
expressed  as  a  'binding  occupational  exposure  limit  value'  or  'BOELV'.  In  parallel,  the  term  OEL  is  used  for 
example when referring to limits set at the national level. In order to simplify this text the term OEL is used to 
refer to any occupational exposure limit (value) whether set in EU or national legislation. 

10 

 
                                                 
CMD provisions apply to any chemical agent which is classified as a 'Category 1' carcinogen (or 
mutagen)  under  the  EU  CLP  Regulation,  thus  to  the  1017  substances  above  mentioned.  They 
also apply – in full – to any chemical agent which would meet the criteria for such classification 
if it were placed on the EU market, which means that employers have a responsibility to identify 
occupational  carcinogens  to  which  workers  may  be  exposed  but  which  have  not  already  been 
classified by their suppliers. 

This  is  the  case  for  example  of  the  so-called  'process-generated  substances'  (PGS).  These  are 
hazardous  'chemical  agents'  such  as  dust,  fumes,  and  gases  which  may,  for  example,  be 
generated  during  the  combustion  of  fuel  by  diesel  engines  used  for  mining,  or  as  by-products 
during production processes, etc. 

PGS have the potential to be major sources of occupational exposure to chemical carcinogens – 
but because they are never 'placed on the market' in the EU they are never subject to the CLP 
classification  system.  This  can  be  confusing  for  employers,  workers,  and  enforcers.  It  is  clear 
that  CMD  controls  apply  to  workplace  carcinogens  –  but  it  may  in  some  cases  be  unclear 
whether a 'process generated substance' is hazardous in this way. 

CMD therefore also includes a list of identified process generated substances in its Annex I. The 
aim  of  this  list  is  to  clarify  for  workers,  employers,  and  enforcers  whether  a  given  chemical 
agent, if it has not otherwise been classified according to CLP, is in scope of the CMD controls. 
Currently, Annex I has 5 entries: 

1.  Manufacture of auramine. 
2.  Work involving exposure to polycyclic aromatic hydrocarbons present in coal soot, coal 

tar or coal pitch. 

3.  Work involving exposure to dusts, fumes and sprays produced during the roasting and 

electro-refining of cupro-nickel mattes. 

4.  Strong acid process in the manufacture of isopropyl alcohol. 
5.  Work involving exposure to hardwood dusts. 

CMD  also  provides  that,  in  any  case,  exposure  of  workers  must  be  kept  below  'binding 
occupational exposure limit values' (OELs). 

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 non-inhalation hazard 
such  as,  for  example,  a  'skin'  notation  where  the  dermal  route  of  exposure  is  scientifically 
considered to be relevant. 

OELs are set in Annex III of the CMD for some chemical agents which fall under the scope of 
the Directive - including some of the PGSs identified in Annex I.16 Annex III currently includes 
limit  values  for  occupational  exposure  for  three  agents:  benzene,  vinyl  chloride  monomer 
(VCM) and hardwood dusts. 

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 

16  Setting an OEL is not always possible. For PGSs specifically, this could be related for example to the fact that 
some  of  them  are  a  complex  mixture  of  carcinogenic  substances,  the  mixture  can  be  variable  as  regards  the 
precise composition and relative quantities of each of these substances. Therefore, it would be necessary to set 
individual  OELs  for  every  component  substance  and  to  carry  out  sampling  and  analysis  for  each  of  them  for 
compliance  purposes,  which  in  practice  would  be  difficult  to  do.  In  other  cases,  an  OEL,  which  is  to  protect 
against  risks  to  health  arising  from  inhalation  of  the  substance,  would  not  be  appropriate  the  critical  route  of 
exposure is not by inhalation but instead is by direct absorption through the skin (dermal exposure). 

11 

 
                                                 
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.  

From a more general perspective, OELs promote consistency by defining a 'level playing field' 
for all users and a common objective for employers, workers and enforcement authorities. This 
leads to a more efficient system of protection of workers' health. 

It  should  be  added  that  for  most  carcinogens  and  mutagens  substances  it  is  not  possible  to 
identify a safe threshold below which the adverse health effects of exposure can be prevented 
completely. The genotoxic mode of action of a substance entails that extremely low amounts of 
a  substance  reaching  the  appropriate  target  (deoxyribonucleic  acid  or  DNA)  may  initiate  a 
tumoral process17. Therefore, although for a genotoxic carcinogenic substance the risk cannot be 
eliminated  by  setting  an  OEL,  the  probability  that  the  effects  occur  can  be  lowered  by 
complying  with  a  limit  value.  In  terms  of  population,  it  can  be  said  that  the  percentage  of 
workers affected by a cancer would be lower if the level of exposure is kept lower. This is the 
reason why the minimisation of the exposure is a basic principle set up in CMD and why OELs 
for  carcinogenic  substances  are  useful  to  prevent  occupational  cancer  although  for  most 
substances  (non-threshold  substances)  there  will  always  be  a  residual  risk  that  could  only  be 
reduced to zero by fully eliminating the presence/use of the substance in the workplace. 

The  CMD  includes  a  general  obligation  for  the  employer  to  reduce  the  use  of  a  chemical 
carcinogen  by,  where  technically  possible,  substituting  to  a  less-  or  non-hazardous  chemical 
agent or process and, when requested to do so by the relevant authorities, submit the findings of 
the associated investigations (CMD Article 4).  The adoption of an OEL does not replace this 
obligation. 

The practical implementation of effective chemical substitution policies can deliver significant 
benefits in terms of protecting the health and safety of workers.  

Effective substitution is associated with a number of issues that are not always easy to evaluate 
in  order  to  facilitate  the  decision  making  process.  It  requires  judgment  to  take  account  of 
workers  health  and  safety  protection,  process  performance,  the  ease  and  cost  of  introducing 
substitutes,  environmental  considerations  and  other  factors  in  making  a  substitution  choice.  
Several  approaches  to  substitution  exist  ranging  from  ad-hoc  approaches  to  methods  that  are 
defined,  structured  and  documented.  Less  sophisticated  substitution  approaches  may  be  more 
suitable  for  smaller  companies  compared  to  larger  better  resourced  organisations  that  have  a 
high  level  of  technical  expertise.  To  make  substitution  happen  in  practice  requires  a  raised 
awareness and involvement of all stakeholders. 

The European Commission recognises the multi-attribute challenges that substitution presents to 
individual  employers  and  has  published  guidance  to  analyse  and  evaluate  the  practical 
implementation of the principle of substitution of hazardous chemicals at the workplace with a 
view to further enhance the protection of workers health and safety while taking into account the 
above-mentioned factors.18 

17  This  constitutes  an  important  difference  between  carcinogenic  effects  and  non-carcinogenic  effects  modes  of 
action, and it is one of the reasons, together with the severity of effects, that justify the existence of a specific 
piece of legislation to protect workers (CMD) in comparison with other chemicals (CAD). 

18  Minimising chemical risk to workers’ health and safety through substitution, European Commission, July 2012, 

12 

 
 
                                                 
Annex I and III of the CMD are not in line with scientific evidence.  

Firstly,  there  is  important  scientific  evidence  that  the  process-generated  substance,  respirable 
crystalline silica, is carcinogenic19. 

Secondly,  two  of  the  three  current  OELs  defined  in  Annex  III  of  the  CMD,  namely  on  'work 
involving exposure to hardwood dust' and vinyl chloride monomer are estimated to be too high 
to adequately protect workers. Available scientific evidence points also to the need to complete 
Annex III with OELs for several additional agents20. 

As  has  been  established,  over  1000  chemical  substances  have  been  given  'harmonised' 
classification  as  category  1  carcinogens  under  the  CLP  Regulation.  Many  of  these  chemical 
agents  are,  however,  almost  certainly  no  longer  used  in  Europe,  having  been  superseded  or 
otherwise  phased  out  of  use  –  and  fewer  again  will  be  present  as  occupational  carcinogens 
today. There are, however, many chemical carcinogens which are known to both be in current 
use in Europe and which pose a risk to workers. 

The Commission initiated work to amend or establish OELs for 25 priority chemical agents in 
2004.21 The selection of these agents took into account the views of stakeholders, principally at 
MS authority level as communicated to the Commission during exchanges of views including at 
the meetings  of the National Experts  Working Group on OELs.  In  addition  for the two of the 
three existing EU OELs (hardwood dust and VCM) the  Scientific Committee on Occupational 
Exposure  Limits  (SCOEL22)  had  adopted  new/revised  Recommendations,  in  2003  and  2004 
respectively that indicated a need to consider the revision of the existing OELs. 

Among  hundreds  of  carcinogenic  substances,  these  25  chemical  agents  are  considered  as  a 
priority for protection of workers and the choice is quite consistent with subsequent third party 
priority  lists.    For  example,  of  the  25  chemical  agents,  11  are  listed  among  the  30  highest 
priority substances in a report published by the Netherlands National Institute for Public Health 
and the Environment23, and 21 were included in a list of 65 candidates for OELs published by 
European Trade Union Congress in 2015.24 As shown by a study contracted by the Commission 
to evaluate impacts of introducing OELs for those 25 chemical agents25 (later on referred to as 
the IOM study), at least 20 million EU workers are considered to be potentially exposed to one 
or several of them. 

19  The  term  'respirable  crystalline  silica'  or  'RCS',  as  used  throughout  this  report  when  referring  to  the  chemical 
agent for which an Annex I entry may be proposed, should be taken to mean 'the respirable fraction of crystalline 
silica dust generated by a work process'. 

20  SCOEL has submitted recommendations for setting new OELs on all the other chemical agents covered by this 
report except for two (o-toluidine and 2-nitropropane). A summary of SCOEL conclusions is provided in Annex 
5. 

21  Because  of  data  challenges  which  will  be  explained  later  in  this  document,  there  exists  no  decisive  exposure 

evidence base for prioritising occupational carcinogens for which OELs should be established. 

22  SCOEL  aims  to  establish  an  exposure  threshold  for  a  given  chemical  agent  below  which  adverse  effects  to 
human health are unlikely to occur (health-based limit values). For carcinogens, such health-based limit values 
can only be derived in very few cases. When no health-based limit value can be set, SCOEL instead estimates 
the  residual  risk  of  developing  cancer  for  workers  at  different  exposure  levels.  In  addition,  SCOEL 
recommendations also address scientific/technical feasibility of monitoring exposure including the availability of 
suitable measurement techniques. 

23  Identifying prevalent carcinogens at the workplace in Europe, RIVM, 2015 
24  List of OEL candidates, European Trade Union Congress, 2015.  To note, this list of 65 chemical agents also 
includes  three  for  which  OELs  already  exist  either  in  the  CMD  (benzene),  in  the  Chemical  Agents  Directive 
98/24/EC (inorganic lead and its compounds), or in the separate Directive 2009/148/EC (asbestos). 

25  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 

13 

 
                                                 
This report deals with 13 chemical agents from the original 25 for which data is available26. 

For the second group of 12 chemical agents, further information gathering and consideration is 
necessary.27 

In the course of the preparatory work, the Commission considered also the possibility to extend 
the scope of CMD to apply also to chemical agents which are toxic for reproduction. However, 
as set out in more detail in annexes 1 and 2 (sections 8.4.3, 9.1, and 9.2.2-3) several policy and 
technical factors, including the already-adequate scope of the CAD, resulted in a conclusion that 
there is no need for further action at this time. 

The first 13 chemical agents and their key characteristics are presented in the Table 1 below. 

Table 1.  Sectors,  types  of  cancer  caused  and  estimated  exposure  levels  for  13  chemical  agents  under 
consideration28 

Classification  Relevant sectors 
CLP30  IARC  

Types of cancer 
caused/other 
illnesses 

No. of 
exposed 
workers29 

Chemical 
agents, 
including CAS 
numbers where 
relevant 

1,2 
Epoxypropane 

75-56-9 

1B 

2B 

1,3 Butadiene 

1A 

1  

106-99-0 

2 Nitropropane 

1B 

2B 

79-46-9 

Acrylamide 

1B 

2A 

79-06-1 

Bromoethylene 

1B 

2A 

593-60-2 

Lymphopoietic 
cancer, 
haematopoietic 
cancer, increased 
leukaemia risk  

Lymphohaema-
topoietic cancer 

485-1,500 

27,600 

Liver tumours31 

51,400 

Pancreatic cancer 

54,100 

Liver cancer 

n/a 

Chemical manufacture; 
synthetic lubricants, oil field 
drilling chemicals; polyurethane 
systems. 

Manufacture of refined 
petroleum products, 
manufacture of rubber products 

Manufacture of basic chemicals, 
manufacture of aircraft and 
spacecraft (downstream use) 

Manufacture of chemicals and 
chemical products, education, 
research and development, other 
business activities, health and 
social work, public 
administration and defence. 

Chemicals and allied 
production; rubber and plastic 
production; leather and leather 
production; fabricated metal 
production for wholesale trade 

26  See point 4.2 for a description of the identification process. 
27  For these chemical agents it is necessary to further consider, for example, the remaining exposure situation for a 
chemical agent which is already subject to an international convention effectively banning sale and use, and to 
ascertain whether the definition for certain PGSs is legally robust. 

28  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 13 chemical agents in 
the report , unless otherwise specified.  

29  Estimates, rounded down 
30  Harmonised (i.e. mandatory) CLP classifications for carcinogenicity 
31  According to animal toxicity studies (no epidemiological evidence). 

14 

 
                                                 
Chromium (VI) 
compounds  

1B 

1 

Ethylene Oxide 

1B 

1 

75-21-8 

Lung cancer and 
sinonasal cancer 

916,00032 

Leukaemia 

15,600 

Production and use of 
chromium-containing pigments, 
paints and metal (conversion) 
coatings. In terms of 
downstream use, chromate 
compounds, including barium 
chromate, zinc chromate, and 
calcium chromate, may be used 
as basic primers and top coats 
in the aerospace sector. 

Extraction of crude petroleum 
and natural gas; service 
activities incidental to oil and 
gas extraction; Manufacture of 
food products, textiles, 
chemicals, chemical products, 
medical, precision and optical 
instruments, watches, clocks; 
Hospital and Industrial 
sterilization; R&D; Public 
Administration and Defence; 
Education; Health and Social 
Work 

Hardwood dust  n/a 

1  

Hydrazine 

1B 

2B 

302-01-2 

o-Toluidine 

1B 

1 

95-53-4 

Wood working industry, 
furniture manufacture sectors 
and construction. 

Sinonasal and 
nasopharyngeal 
cancers 

3, 333,000 

Lung and colorectal 
cancer 

2,124,000 

Bladder cancer 

5,500 

Chemical blowing agents; 
agricultural pesticides; water 
treatment 

Manufacture of chemicals, 
chemical products and man-
made fibres; Manufacture of 
rubber products; Research and 
development; Public 
administration and defence; 
education; health and social 
work. 

Respirable 
Crystalline 
Silica 
(RCS) 

Refractory 
Ceramic Fibres 
(RCF) 

n/a 

1 

1B 

2B 

Mining, glass manufacturing, 
construction and electricity, gas, 
steam and hot water supply 
industries.  

Lung cancer, 
silicosis 

5,300,00033 

Manufacturing (fibre 
production, finishing, 
installation, removal, assembly 
operations, mixing/forming) 

Adverse respiratory 
effects, skin and eye 
irritation; possibly 
lung cancers 

10,000 

Vinyl Chloride 
Monomer 

1A 

1 

Manufacture of chemicals and 
chemical products (VCM and 

Angiosarcoma, 
hepatocellular 

15,000 

32  This figure is an estimate for all chromium VI compounds. 
33  According to the IOM Research Project P937/99 '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'  published  in  May  2011  (p.  21)  'approximately  5,3mln.  employees  in  the  EU  were 
potentially exposed to RCS in 2006. Over 4 million of these workers are in the construction sector'. 

15 

 
 
                                                 
(VCM) 

75-01-4 

PVC production) 

carcinomas 

Adoption of the proposal to review Annexes I and III of the CMD with regard to a first batch of 
carcinogens  is  envisaged  for  the  first  semester  of  2016  in  the  Commission  Work  Programme. 
Preparatory  work  has  been  going  on  since  2004,  and  representatives  of  Member  States 
authorities, employers' and workers' representative bodies within the framework of the tri-partite 
Advisory Committee on Safety and Health (ACSH) strongly anticipate a 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'.34 

1.1.3 Inadequate  OELs  at  MS  level  have  negative  consequences  for  workers  and  businesses 

across the EU 

Under  the  CMD,  Member  States  may  adopt  a  national  limit  value  that  is  lower  (i.e.  more 
stringent) than the EU value. They can also adopt OELs for chemical agents for which it has not 
been done at EU level. This is consistent with the ultimate objective of the Directive, which is to 
minimise the level of exposure, as it allows for further advances to take place at Member State's 
level in light of country-specific and industry-specific developments. 

One or more Member States have indeed set limit values for all of the agents covered in this IA. 
For example, most Member States have set limits for ethylene oxide and acrylamide. Less than 
half have done so for bromoethylene or o-toluidine. 

In the absence of EU OELs, national scientific committees and/or other national bodies need to 
independently  evaluate  each  carcinogen  leading  to  a  repetition  of  identical  tasks  in  several 
Member States. 

While the possibility to set national OELs is in line with the CMD provisions, in practice, where 
national  OELs  exist  they  vary  considerably  in  some  cases,  leading  to  significantly  different 
levels of protection. For example for 1,3 butadiene, the values range from 4.5 to 100 mg/m3. For 
ethylene oxide, values range from 0.84 to 90 mg/m3. A comprehensive overview of the national 
OELs  for  each  of  the  chemical  agents  covered  in  this  report  is  provided  in  Annex  9  and  a 
summary overview table can be found in Annex 6. 

The  lack  of  national  OELs  for  some  chemical  agents,  and  the  high  levels  of  others,  not  only 
leads to inadequate protection for EU workers but can also have negative consequences for the 
internal market, because businesses located in Member States with less stringent levels (i.e. with 
absent or higher OELs) would benefit from an undue competitive advantage. For example, 1,2- 
epoxypropane  producers  in  FR  and  RO  have  to  comply  with  exposure  limits  10  times  higher 
(i.e. less constraining) than in other producing countries, such as DE, ES and NL (50 mg/m3 vs 5 
mg/m3).  Even  if  the  minimisation  obligation  applies  to  all  employers  in  Europe,  these  undue 
competitive  advantages  would  continue  to  exist  in  the  absence  of  an  EU-wide  OEL,  because 
both employers and surveillance authorities would need to rely on their own judgement on what 
is "technically possible". 

Divergence in national OELs may be partially  due to differences in the methodology used for 
the  scientific  evaluation  of  a  carcinogen  by  the  respective  national  limit  setting  committees. 
More  recently  established  national  OELs  may  be  different  (for  example  more  stringent)  than 
those set earlier as a result of improved scientific understanding or availability of data.  Further, 

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

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

16 

 
 
                                                 
specific production process(es) used in one Member State may allow for lower OELs to be set 
compared to use of alternative production process (for example) in another Member State. 

Where Member States have, in the absence of EU OELs, set national OELs that vary from each 
other this has the potential to create uncertainty on what is expected of employers in terms of 
risk  management.  This  may  be  perceived  as  inefficiency  of  the  system,  in  particular  by 
employers that operate in more than one Member State. 

EU-level OELs do not intend to completely eliminate the variation in national OELs but rather 
ensure  that  all  Member  States  introduce  a  minimum  level  of  protection  which  is  considered 
appropriate in light of scientific knowledge and the state of technological development. Even if 
Member States retain the possibility to adopt stricter levels, EU OELs significantly reduce the 
scope of variation by introducing an upper limit for acceptable exposure levels. 

As  explained  earlier,  employers  have  the  obligation  to  achieve  exposure  levels  as  low  as 
technically  possible  to  be  compliant  with  the  minimisation  principle  under  the  CMD.  What  is 
technically  possible,  however,  may  be  different  for  the  same  chemical  agent,  depending  for 
example on the sector of the industry and the specific type of use of the chemical agents. 

Substances  such  as  RCS,  for  example,  can  occur  in  very  diverse  workplace  situations  and 
therefore the possibilities to control exposures will differ. Without an EU-wide OEL, employers 
who  would  like  to  be  sure  to  comply  with  the  legislation  ("minimisation  to  as  low  a  level  as 
technically  possible")  would  need  to  embark  on  an  extensive  research  into  different  practices 
existing  across  EU  Member  States  and  in  different  types  of  industries  to  arrive  at  an 
understanding of what might be the appropriate and feasible exposure limit review for their type 
of  business.  In  that  sense  an  EU-wide  OEL,  based  on  a  generally  accepted  methodology  and 
validated through tripartite discussions as a common denominator should be feasible for all uses 
of the carcinogen, which simplifies compliance for business. 

Similarly, for workers, in the absence of an OEL or where national OELs are too high, it would 
be challenging to collect evidence that exposure levels in a specific factory are higher than what 
should be possible. An OEL facilitates therefore discussions between employers and workers on 
this matter by setting an agreed benchmark for compliance. 

1.2  Who is affected by the problem and how?  

As mentioned above, the total number of deaths attributed to occupational cancer in the EU is 
reported to be 102,500 for 201135. 

Epidemiological  studies  indicate  that  occupational  exposures  cause  5.3–8.4  per  cent  of  all 
cancers36. However, the rates are not the same for all cancers, for some, such as sinonasal cancer 
linked to wood dust exposure, work-related cancers are estimated in some countries to account 
for almost half of all cancers in some countries of this type.37 

In 2012, cancers of the lung, colorectal, breast and stomach were the most common fatal forms 
of cancer in Europe. The most common cancer sites were cancers of the female breast, followed 

35  Eliminating  occupational  cancer  in  Europe  and  Globally,  Takala,  J,  European  Trade  Union  Institute,  October 

2015.  

36  Eliminating  occupational  cancer  in  Europe  and  Globally,  Takala,  J,  European  Trade  Union  Institute,  October 

2015.  

37  Imbernon  E.,  «  Estimation  du  nombre  de  cas  de  certains  cancers  attribuables  à  des  facteurs  professionnels  en 
2003,  
de 

France 
Available at http://www.invs.sante.fr/publications/2003/cancers_pro/rapport_cancer_pro.pdf. 

sanitaire, 

Institut 

veille 

», 

17 

 
                                                 
by colorectal, prostate and lung, which all together represent half of the overall burden of cancer 
in Europe.38 

According  to  a  UK  study  based  on  2005  data,  industries  and  occupations  with  high  cancer 
registrations include construction, metal working, personal and household services, mining, land 
transport,  printing/publishing,  retail/hotels/restaurants,  public  administration/  defence,  farming 
and  several  manufacturing  sectors.  56%  of  occupational  cancer  registrations  in  men  are 
attributable to work in the construction industry (mainly mesotheliomas, lung, stomach, bladder 
and non-melanoma skin cancers).39 

The chemical agents subject to this IA have a direct impact on developing the above mentioned 
types of cancer and are relevant to the sectors with high rates of cancer registrations.40 

For the workers and their  families, cancer results not  only  in substantial  quality  of life losses, 
but also in direct health care costs and indirect loss of present and future earnings (net of taxes) 
both for the person affected and for the carers, in addition to the administration costs related to 
the time and expenses incurred claiming for benefits, waiting for treatment etc. 

Occupational  cancer  also  impacts  the  economy  at  large,  reducing  labour  supply  (either 
temporarily  or  permanently)  not  only  by  the  person  affected  but  also  by  his/her  carers, 
decreasing labour productivity, and increasing the burden on public finances through avoidable 
public  expenditure  on  health  care,  disability  benefits,  pensions  for  early  retirement,  and  other 
benefits. 

As an illustration, according to a study published in November 2013, around 8,000-8,500 deaths 
per  year  due  to  occupational  cancer  are  estimated  to  occur  in  Italy  alone,  corresponding  to 
170,000  Potential  Years  of  Life  Lost  and  more  than  16,000  Potential  Years  of  Working  Life 
Lost,  leading  to  around  360  mln   euros  in  indirect  economic  loss.  41  To  these  add  the  direct 
health  care  costs  of  occupational  cancer  in  Italy,  estimated  at  around  456  mln euros.  Another 
study  conducted  in  Spain  estimated  direct  costs  for  diagnosis  and  treatment  of  occupational 
bladder  and  lung  cancer  to  be  about  88  mln  euros.42  This  did  not  cover  indirect  costs  such  as 
costs of absences, production loss, loss of income and impairment.43 

For Member States, occupational cancer leads to increased healthcare costs related to treatment 
and rehabilitation, as well as to higher expenditure on associated inactivity and early retirement 
and  compensation  for  recognised  occupational  diseases.  It  also  increases  administrative  and 
legal  costs  related  to  the  handling  of  requests  for  benefits  and  dealing  with  recognized 
cases. Foregone earnings and income as a result of ill health also lead to tax revenue losses for 
social security systems. 

For business, occupational cancer also implies costs in terms of productivity, as they lose skilled 
workers and need to spend more in job search and training of new workers. Given the often long 
time  lag  between  exposure  and  illness  and  the  probability  of  workers  changing  employers 
during their work career, the risk of future productivity losses is unlikely to be internalised by 

38  Cancer  incidence  and  mortality  patterns  in  Europe:  Estimates  for  40  countries  in  2012,  Ferlay,  J.  et  al., 

European Journal of Cancer, 49 (2013), pp. 1374–1403. 

39  Occupation and cancer in Britain. Rushton, L. et al., British Journal of Cancer. 2010 Apr 27;102(9):1428-37  
40  According to animal toxicity studies 2 nitropropane may cause liver tumours in humans (although it should be 

noted that there is no epidemiological evidence to substantiate this). 

41  The burden of mortality with costs in productivity loss from occupational cancer in Italy, Am J Ind Med. 2013 

Nov;56(11):1272-9. doi: 10.1002/ajim.22224. Epub, June 24 2013. 

42  García Gómez M, Urbanos Garrido R, Castañeda López R, López Menduiña P. Costes sanitarios directos de las 
neoplasias de pulmón y vejiga de origen laboral en España en 2008. Rev Esp Salud Pública. 2012; 86: 127-38. 
Available at http://scielo.isciii.es/scielo.php?pid=S1135-57272012000200002&script=sci_arttext&tlng=em 

43  See Annex 4 for a discussion of terms used here. 

18 

 
                                                 
companies,  and  therefore  not  factored  into  present  businesses  decisions.  Depending  on  the 
relative strength of collective bargaining, some of the affected sectors/companies may also need 
to  pay  higher  wages  to  compensate  for  the  higher  occupational  risk,  which  would  affect  their 
competitiveness vis-à-vis otherwise similar companies which are confronted with less organised 
labour.  Finally,  businesses  located  in  Member  States  with  where  national  OELs  are  relatively 
stringent may be at a competitive disadvantage vis-à-vis enterprises in Member States with no or 
higher OELs. 

An indicative estimate of the direct and indirect health costs related to the agents covered in this 
impact assessment can be found in the following section. 

1.3  How would the problem evolve? 

Estimations on the numbers of deaths and health costs between 2010 and 2069 have been made 
in  case  no  action  is  taken  (baseline  scenario)  regarding  the  chemical  agents  subject  to  this 
IA.44,45 These are summarized in the Table 2 below. 

Table 2.  Estimated cancer deaths, cancer cases and related health costs in case no action is taken (baseline 
scenario), 2010-2069 

Chemical agent 

Expected no. of 
deaths 

Expected no. of Cancer 
cases  

estimated health 
costs 

2010 – 2069  

2010 – 2069  

2010 – 2069  

1,2 Epoxypropane 

-46 

1,3 Butadiene 

2 Nitropropane 

Acrylamide 

Bromoethylene 

Chromium (VI) 
compounds 

100 
Not assessed48 

230 
-49 

17,000 

Ethylene oxide 

0 

Hardwood dust 

5,000 

Hydrazine 

o-Toluidine 

Refractory ceramic 
fibres (RCF) 

710 

150 

50 

-47 

160 

€2.5 mln - 10.7 mln 

€41 mln - 167 mln 

Not assessed 

n/a 

250 

0 

24,000 

0 

12,000 

2,500 

490 

60 

€156 mln - 326 mln 

n/a 

€8.6 - 27 bln 

None 

€3 bln - 16 bln 

€0.5 bln - 3 bln 

€86 mln - 696 mln 

€33 mln -83 mln  

44  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 

45  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. 

46  According to the IOM Research Project, less than one death per year was predicted from past or future exposure 

- 100 attributable YLLs during 2010-2069 period. 

47  Less than one per year. 
48  According  to  the  IOM  Research  Project,  no  baseline  health  impact  was  made  because  there  was  insufficient 

epidemiological evidence to sustain such an assessment 

49  According to the IOM Research Project, no deaths were predicted from past or future exposure 

19 

 
                                                 
 
 
 
Respirable crystalline 
silica (RCS) 

440,000 

Vinyl chloride 
monomer (VCM) 

300 

470,000 

€192 bln - 493 bln 

300 

€194 mln - 472 mln 

It  is  anticipated  that  there  would  be  around  440,000  deaths  from  exposure  to  respirable 
crystalline  silica  (RCS)  and  a  similar  number  of  new  cancer  cases.    The  related  health  costs 
would range between 192 bln and 493 bln euro.  The social partners, representing 18 European 
industry  sectors  signed  in  2006  a  European  Multi-Sectoral  Social  Dialogue  Agreement  on 
Workers'  Health  Protection  through  the  Good  handling  and  Use  of  Crystalline  Silica  and  its 
products (NEPSi).  The impact of NEPSi on the reduction of cancer cases and deaths in those 
sectors50 implementing the Agreement is under evaluation – results are not available to inform 
this  assessment.    Exposure  to  hard  wood  dust,  which  potentially  concern  3  mln  workers  in 
Europe,  is  expected  to cause 12,000 cases  of cancers and 5000 deaths over the next  60 years, 
with estimated health costs between 3 bln and 16 bln euro. On the other hand, relatively smaller 
effects are expected from exposure to o-Toluidine: 490 new cancer cases and 150 deaths before 
2050. 

These 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. 
As this varies across the chemical agents, more information will be provided in Section 5 of the 
report about the specific situation for each of the carcinogens as well as on the sources of the 
information.  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. 

Table 1 in Annex 6 presents the current limit values in the EU Member States. The information 
regarding  existing  national  OELs51  was  gathered  through  an extensive  2014  survey.52  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. 

50  Aggregates, cement, ceramics, foundry, glass fibre, special glass, container glass, flat glass, industrial minerals, 

mineral wool, natural stones, mining, mortar, pre-cast concrete sectors and clay sector.  

51  There is no obligation for Member States to inform the Commission about their intentions update their national 

lists of OELs, apart from initiatives which would be related to OELs established at EU level. 

52  Further information on this survey is provided in Annex 2 of this document 

20 

 
 
                                                 
2  WHY SHOULD THE EU ACT? 

2.1  Does the EU have the right to act? 

The Treaty on the Functioning of the EU (TFEU) in Article 153 empowers the EU to support 
and complement the activities of the Member States as regards the protection of workers' health 
and  safety,  and  to  adopt  by  means  of  Directives,  minimum  requirements  for  gradual 
implementation.  On  this  basis  the  CMD  provides  a  specific  basis  for  action.  For  more  details 
regarding the full legislative framework see Annex 7. 

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

Limit  values  under  the  CMD,  which  according  to  the  Directive  are  regarded  as  an  important 
component of the general arrangements for the protection of workers53, should be established for 
all those carcinogens and mutagens for which the available information, including scientific and 
technical data, make this possible54, and must also be revised whenever this becomes necessary 
in the light of more recent scientific data. 

One of the most important advantages of setting OELs is that they provide robust and objective 
benchmarks to help demonstrate compliance with the current legal framework.  They establish 
ceiling exposure values above which exposure should not occur (in a weighted average over one 
working  day).    This  enables  the  employer,  based  on  the  risk  minimisation  approach,  to 
implement the OSH risk management measures that reflect the needs of their sector.  In some 
cases it may be possible to achieve exposure reductions well below the level at which the OEL 
is set, for other sectors this may be less achievable.  However, in all cases the resultant exposure 
should not exceed the OEL and over time, with developments in technology, there should be a 
trend for overall exposures to reduce to a minimum. 

The concept and use of OELs is well understood by all the main stakeholder groups.  As such 
they are 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. They can also be used 
by  process  plant  and  machinery  designers  when  planning  new,  or  considering  alterations,  to 
existing process plant. 

OELs  therefore  make  an  effective  contribution  to  the  practical  implementation  of  the 
requirements  in  the  legislation  for  prevention  and  reduction  of  exposure  to  chemical 
carcinogens. 

The  continued  support  from  stakeholders  for  OELs  was  restated  during  a  meeting  on  18th 
November  2015  of  members  of  the  tri-partite  Working  Party  on  Chemicals  to  discuss  those 
aspects  of  the  overall  evaluation  of  the  EU  OSH  acquis  that  are  relevant  to  chemicals  risk 
management. During this meeting the Members States', employers' and workers' representatives 
agreed  that  'OELs  are  an  important  tool  for  chemical  risk  management  at  the  workplace  and 
there  is  a  need  to  adopt  values  for  more  substances  based  on  duly  justified  reasoning.    For 
example an early focus should be on carcinogenic, mutagenic and reprotoxic substances'. 

In addition, during 2015, Commission services asked the Senior Labour Inspectors Committee, 
via its working group on chemicals (CHEMEX), to assess the utility of OELs from an enforcer's 
perspective,  including  the  question  'Are  OELs  considered  (by  labour  inspectors)  to  be 
critical/not important when carrying out inspections'?55  All respondents considered OELs to be 
essential and particularly valuable when carrying out inspections and enforcement. 

53  recital 13 of Directive 2004/37/EC 
54  recital 12 of Directive 2004/37/EC 
55  Summary  of  the  responses  to  SLIC  CHEMEX  KSS  Questions  Set  -  Implementation  of  occupational  exposure 

limits at national level – draft response document 

21 

 
                                                 
It  can  be  concluded  that  OELs  provide  an  added  value  as  a  common,  and  well  understood, 
objective  measure  to  better  facilitate  the  practical  implementation  of  the  general  requirements 
for prevention and exposure reduction.  There is a clear support for their continued use from key 
stakeholders. 

For  some  sectors  it  may  be  that  a  given  OEL  is  the  best  that  can  be  achieved  but  in  others 
sectors, or for specific uses, it is possible that much better exposure values can and should be 
achieved  –  this  is  taken  into  account  in  the  minimum  standard  nature  of  OSH  in  general  and 
OEL setting in particular. 

Data  presented  in  this  report  indicate  wide  differences  in  the  Member  States  regarding  the 
setting  of  OELs  for  the  identified  carcinogenic  chemical  agents56.  Some  Member  States  have 
already  established  legally  enforceable  OELs  which  are  at  the  same  value  or  lower  than  the 
value recommended by the Advisory Committee on Safety and Health at Work (ACSH). This 
demonstrates  that  unilateral  national  action  is  possible  as  regards  setting  an  OEL  for  these 
chemical  agents.  However,  as  shown  in  Table  2  in  Annex  6  there  are  also  many  cases  where 
Member States have no OELs or ones which are less protective of worker health than the value 
recommended by ACSH. 

Under such circumstances a minimum basis of protection against the risks arising from workers' 
exposure to these carcinogens cannot be ensured for all EU workers in all Member States by an 
action  taken  by  Member  States  alone.  Table  4  in  Annex  6  provides  an  overview  of  the 
proportion of potentially exposed workers who lack such legal protection and this factor is taken 
into  account  in  the  analysis  of  impacts  of  introducing  an  OEL  for  each  of  the  considered 
carcinogens. It follows that an action taken at the European Union level to achieve this objective 
appears to be necessary and in line with Article 5(3) of the Treaty on European Union. 

Absent  or  too  high  OELs  also  provide  a  potential  incentive  for  companies  to  locate  their 
production facilities in Member States with the lower standards. This distortion of the internal 
market may be reduced by establishing clear minimum standard OELs at EU level. 

Amending the CMD can only be done by action at EU level and after a two-stage consultation 
of the social partners (management and labour) in accordance with Article 154 TFEU. 

2.3  What are the EU instruments relevant to dealing with carcinogens at the workplace? 

From  the  mid-1960s  the  European  Union  developed  a  legal  framework  addressing  control  of 
chemical risks under both social policy and internal market areas of EU policy.  This framework 
places duties on authorities, businesses, and individuals to manage risks associated with the sale 
and  use  of  chemicals.  By  the  late  1990s  a  comprehensive  and  sophisticated  system  of 
interdependent  Directives  and  Regulations  had  been  established  to  protect  humans  and  the 
environment from hazardous chemicals. 

To  protect  workers  from  chemical  carcinogens  both  employers  and  authorities  must  apply  the 
same three stages necessary for all risk control:  i) identify what harm might be caused ('hazard 
identification'); ii) identify the likelihood and severity of the harm actually being caused ('risk 
assessment');  and  iii)  where  necessary  put  in  place  measures  to  mitigate  harm  ('risk 
management'). 

Directives setting out an agreed system for chemical hazard identification (i) were developed – 
augmented where necessary by additional provisions in topic specific Directives.  The outcomes 
of this hazard identification are then applied in Directives and Regulations focussed on the key 
areas of chemical risk – in the case of worker protection from chemical carcinogens these were 
laid down in the CMD. 

56  See Table 1 in Annex 6. 

22 

 
                                                 
A subsequent process of chemicals risk assessment (ii) by European authorities built on this to 
identify measures needed to protect the environment or humans as consumers, members of the 
public,  or  workers.  This  risk  assessment  resulted  in  recommendations  for  regulatory  risk 
management (iii) from a suite of available options. 

The  key  EU  risk  management  outcomes  for  the  protection  of  workers  from  chemical 
carcinogens  were  CMD  OELs  (under  social  policy)  and/or  'restrictions'  on  the  placing  on  the 
market and/or use of certain chemicals (principally under internal market policy). 
The REACH Regulation57, which was adopted in 2006, 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  therefore  protect  workers  from  risks  associated  with 
exposure  to  carcinogens.  The  two  legal  acts  are  complementary.  CMD  is  a  more  targeted 
measure  intended  for  protection  of  those  employed  by  others  from  occupational  carcinogens, 
while REACH applies more broadly to protect the health of humans and also the environment 
and also offers mechanisms which can be used to target risk controls to protect workers. 

A chemical carcinogen may appear on both CMD Annex III and REACH Annex XIV without 
systematic conflict58. The OSH ʻFramework Directiveʼ – 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. 

REACH is designed to integrate with the rest of the EU legal framework with which it co-exists 
– including CMD. As a key example of this, REACH does not include a mechanism to set EU 
OELs for carcinogens – these are properly established under social policy Directives where the 
social partners and co-legislators play a more prominent role. 

REACH generates information on chemical agents which are 'placed on the market' (above one 
tonne  per  year)  and  used  in  the  EU.  It  also  includes  the  'authorisation'  and  'restriction' 
mechanisms – both of which may, in some cases, be available as risk management options for 
occupational carcinogens. 

Carcinogens are one of several types of hazardous substance which can be added to Annex XIV 
to REACH, meaning they become subject to 'authorisation'. Once a given 'sunset' date is passed, 
these substances may only be placed on the EU market and/or used when an authorisation has 
been applied for and granted by the European Commission, taking into account the advice of the 
European Chemicals Agency, that either the risks associated with use are adequately controlled 
or that, if this is not possible, ongoing use of the substance is socioeconomically justified and 
there are no suitable alternatives. 

The  Commission  may  make  exemptions  from  REACH  authorisation  under  certain  conditions, 
including where specific Union legislation already exists which imposes minimum requirements 
relating to the protection of human health for the use of a substance.  So far no exemption has 
been made for substances used at the workplace. 

57  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 

58  Of the 13 chemical agents considered here for listing in CMD Annexes I (PGSs) or III (OELs) three have been 
added  (in  some  form)  to  the  Candidate  List  as  'substance  of  very  high  concern'  (SVHCs)  :  Hydrazine,  o-
Toluidine,  and  RCFs.  RCFs  have,  further, been recommended  by  ECHA  for  inclusion  in  Annex XIV.  Certain 
chromium (VI) compounds have been identified as SVHCs on the Candidate List and also, subsequent to ECHA 
recommendation, have been added to REACH Annex XIV. 

23 

 
                                                 
Restrictions  set  conditions  under  which  placing  on  the  market  and/or  use  of  a  chemical 
substance (or mixture or article containing it) may be permitted.  These range from a near-total 
ban through to substance concentration specifications or established risk management measures 
to be observed by 'downstream users'. 

Restrictions are a flexible, targeted chemicals risk management option carried forward from the 
pre-REACH EU chemicals framework.  Restrictions and OELs have long co-existed as different 
possible  outcomes  from  the  EU  chemicals  risk  assessment  process  –  indeed  four  of  the  five 
existing  binding  OEL  values  established  at  EU  level  under  the  OSH  Directives  (asbestos, 
benzene, lead, and vinyl chloride) are already partnered with REACH restrictions. 

As  a  result  of  their  flexibility  it  is,  conceptually,  possible  to  establish  an  'OEL-like'  exposure 
limit via a REACH  restriction – in 2013 the Netherlands REACH authorities proposed such a 
measure.    In  response,  in  November  2013,  the  lead  Commission  services  for  the  REACH 
Regulation wrote to the European Chemicals Agency (ECHA), with the common Commission 
services'  view  that  'any  proposal  for  adoption  of  an  exposure  limit  value  at  the  occupational 
premises  should  not  be  implemented  under  REACH  and  should  only  be  set  under  the 
appropriate  workers'  protection  legislation,  which  is  specifically  designed  to  establish  and 
implement OELs'.  In the same month the ACSH adopted an Opinion formally expressing the 
views of the Member States, employers, and workers' representatives that the OSH acquis is the 
more appropriate way to establish exposure limits for worker protection to chemicals.59 

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  REACH  status  (authorisation  and/or  restriction)  of  the  13  chemical  agents  under 
consideration in this report is as follows: 

  Out of scope of REACH: hardwood dust, process-generated RCS. 

  On the Candidate List of 'substances of very high concern' potentially to be made subject 

to authorisation: acrylamide, hydrazine, RCF, o-toluidine. 

  Currently subject to authorisation: some chromium VI compounds. 

Currently subject to restriction: acrylamide, restricted above a certain  concentration for 
the placing on the market or use in grouting (REACH Annex XVII Entry 60); chromium 
(VI) compounds, restricted above a certain concentration for the placing on the market or 
use in cement, with certain exemption (REACH Annex XVII Entry 47); vinyl chloride, 
restricted  (REACH  Annex  XVII  Entry  2)  for  use  as  an  aerosol  propellant.  All  of  the 
chemical agents in question, where placed on the market, are restricted for supply to the 
general public (REACH Annex XVII Entries 28 and 29). 

A more detailed list of REACH status of the concerned chemical agents can be found in Annex 
7 (14.2.1). 

2.4  How does this initiative relate to the envisaged review of the OSH acquis? 

The CMD is part of an overall OSH acquis, comprising the Framework Directive 89/391/EEC 
and 23 individual directives. The Commission is currently finalising an ex-post evaluation of the 

59  The  Advisory  Committee  on  Safety  and  Health  at  Work,  Opinion:  Protection  of  workers'  health  from  risks 
arising from exposure to chemicals at the workplace: EU Occupational Exposure Limit Values under OSH and 
limit values under other EU legislation, Doc. 01903/13, adopted on 28 November 2013 

24 

 
                                                 
acquis, covering the period 2007-2012 and 27 Member States. This evaluation consists of a wide 
assessment  of  the  legislation,  including  in  terms  of  benefits,  research  and  new  scientific 
knowledge.  It  also  falls  under  the  remit  of  the  Commission's  Regulatory  Fitness  and 
Performance  Programme  (REFIT),  which  aims  to  ensure  that  the  EU  regulatory  framework  is 
relevant,  coherent,  effective,  efficient,  provides  EU  added  value  and  targets  ensuring  the 
avoidance of any unnecessary regulatory burden. 

The results of the ex-post evaluation may lead to the further assessment of specific issues and 
potentially  impact  assessments  covering  possible  initiatives  to  improve  the  operation  of  the 
regulatory framework.  The Commission will be working throughout 2016 on the follow-up of 
the evaluation as regards collection of any necessary further evidence and justifications for the 
modernisation  of  OSH  framework  with  the  aim  of  increasing  effectiveness  and  efficiency, 
reducing  regulatory  burden  whenever  possible  without  undermining  the  public  interest 
objectives of the legislation. 

Within  the  framework  of  the  overall  ex-post  evaluation  the  CMD  was,  along  with  the  other 
individual  OSH  Directives,  subject  to  a  specific  assessment  through  an  external  evaluation 
study. The conclusions of this study refer mainly to broader issues such as the interface between 
the CMD and REACH, or the possibility to merge the CMD with the Chemical Agents Directive 
(CAD)60.  The  former  is  discussed  at  section  2.3  in  this  report.  As  for  the  latter,  no  clear 
conclusions can be drawn as views of stakeholders at national and EU level are quite polarised. 
There is however consensus on maintaining the material provisions of the two acts. 

Secondly, concerning specifically OELs, experts discussions conducted in the framework of the 
evaluation  confirmed  that  these  are  an  important  tool  for  chemical  risk  management  at  the 
workplace. It was indicated that the terminology used to describe different types of OELs (and 
corresponding procedures) should be aligned and guidance on the practical use of OELs should 
be developed.  

The fact that the evaluation did not question the existence of OELs and pointed to the need to 
revise them and adopt new ones, together with the further evidence and analysis gathered in the 
framework of the impact assessment, support the conclusion that the two technical annexes of 
the Directive should be updated. 

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 ensure up-to-date 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 and create a better level playing field for economic operators. 

60  Evaluation of the Practical Implementation of the EU Occupational Safety and Health (OSH) Directives in EU 
Member States – Report by directive: Directive 98/24/EEC on the protection of workers from the risks related to 
chemical agents at work, section 7.4 'Coherence; Merging the CAD and CMD', COWI, November 2015, p. 128-
129. 

25 

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

fundamental rights? 

The objectives of the initiative are consistent with the fundamental rights as set out in the EU 
Charter of Fundamental Rights, in particular article 2 (Right to life) and article 31 (Right to fair 
and just working conditions which respect his/her health, safety and dignity). 

Ensuring a safe and healthy work environment for over 217 mln workers in the EU is a strategic 
goal  for  the  European  Commission  according  to  the  recent  Communication  from  the 
Commission on the EU Strategic Framework on Health and Safety at Work 2014 – 2020.61 One 
of the main challenges identified in the EU OSH Strategy is to improve the prevention of work-
related diseases by tackling existing, new and emerging risks. 

Improving working conditions and preventing workers from suffering serious accidents and/or 
occupational  diseases  and  promoting  workers’  health  throughout  their  working  life,  is  a  key 
principle  in  line  with  the  ambition  for  a  Triple  A  Social  Europe  rating  set  by  the  Juncker 
Commission. It also has a positive impact on productivity and competitiveness and is essential 
to  promote  longer  working  lives  in  line  with  the  Europe  2020  strategy’s  objectives  for  smart, 
sustainable and inclusive growth.62 

The objectives of this initiative are also in line with and complementary to the ILO Convention 
no. 170, concerning safety in the use of chemicals at work. The Convention, adopted so far by 
six  EU  Member  States63,  establishes  minimum  universal  standards  on  OSH  to  be  observed 
worldwide.  CMD  and  CAD  reflect  these  standards  and  go  further,  establishing  more  stringent 
and  protective  conditions  that  EU  Member  States  are  in  a  position  to  implement.  They  also 
provide a stronger motive for MS to enact national measures as they are legally bound to do so. 
ILO  170  is  intended  to  complement  and  explicitly  envisages,  inter  alia,  (Article  13),  that 
'Employers  shall:  (a)  ensure  that  workers  are  not  exposed  to  chemicals  to  an  extent  which 
exceeds exposure limits or other exposure criteria for the evaluation and control of the working 
environment established by the competent authority, or by a body approved or recognised by the 
competent authority, in accordance with national or international standards (…)'. 

4  WHAT ARE THE VARIOUS OPTIONS TO ACHIEVE THE OBJECTIVES? 

4.1  Complementary measures 

During discussions in the ACSH64 the need for further guidance was called for, in particular on: 

the minimisation obligation under Article 5 of the CMD Directive; 

 
  methodologies for the development of OELs for carcinogens; 
  measurement methodologies regarding exposure to hardwood dust,  taking account of 

mixed exposure to both hard- and softwood dust; 

  how to take into account in the cost-benefit analysis the EU Charter of Fundamental 
Rights, in particular Article 1 (Human dignity), Article 2 (Right to life) and Article 3 
(Right to integrity of the person). 

In the same vein, one of the conclusions of the Social Partners consultation was that there was a 
need  for  effective  implementation  of  training  and  information  requirements,  which  are  a  key 
aspect of the prevention policy. Workers called the Commission to set up a strategy to improve 
coordination  and  sharing  of  information  at  EU  level.  Employers  indicated  that  there  was  an 

61  http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52014DC0332&from=EN  
62  COM(2010) 2020 and COM(2014) 130 final 
63  Finland, Germany, Italy, Luxembourg, Poland, and Sweden 
64  Opinion of the ACSH of 05/12/12 

26 

 
 
                                                 
added  value  in  the  preparation  of  guidance  documents  with  recommendations  on  workers 
protection against carcinogens and mutagens exposure. 

Most  of  these  actions  are  ongoing  or  will  be  undertaken  as  complementary  measures  to  this 
initiative.  These  are  not  alternative  options  to  updating  the  CMD  but  are  rather  part  of  the 
baseline  and  will  further  reinforce  potential  positive  effects  of  the  considered  options.  Non-
binding  guidance  cannot  address  the  issues  identified  in  the  problem  definition;  only  clear 
listing  of  chemical  agents  under  the  CMD  and  setting  OELs  will  introduce  the  legal  certainty 
needed  for  employers,  workers  and  enforcers  with  regard  to  managing  the  exposure  to 
carcinogenic chemical agents in the workplace. 

4.2  Discarded options 

Several other options which could be considered as alternative mechanisms to control and limit 
exposures  to  carcinogens  in  the  workplace  have  been  discarded  as  they  were  considered 
disproportionate or less effective in reaching the objectives of this initiative. 

A. Banning the use of the carcinogenic chemical agents 

As explained above, for most carcinogens even a very low OEL does not completely eliminate 
the risk of triggering a cancer. In that sense the risk could only be reduced to zero by eliminating 
the presence/use of the substance in the workplace. 

Indeed, substitution is the first option in the hierarchy of risk management measures under the 
CMD  that  an  employer  needs  to  consider.  This  means  that  if  it  were  technically  feasible, 
employers  should  have  already  replaced  use  of  the  concerned  chemical  agents  with  safer 
alternatives. 

Wherever substitution is a suitable alternative for use of the 13 chemical agents in question then 
the CMD already requires this, regardless of the existence or otherwise of an OEL.  As this legal 
standard already establishes that these carcinogens should not be used in the workplace where 
alternatives  are  available,  establishing  a  more  strict  prohibition  in  the  form  of  a  ban  would 
constitute a disproportionate measure with a strong negative impact on businesses. Moreover, in 
the case of process-generated substances such as hardwood dust or RCS, banning is not only a 
counterintuitive option but it would also result in  operational challenges which could result in 
closure  of  otherwise  viable  and  compliant  businesses  –  potentially  across  whole  industry 
sectors. 

B. Self-regulation (industry voluntary agreements) 

The NEPSi Agreement, including the practical guidelines to risk management, contributes to the 
overall protection of workers health in the affected employment sectors. 

NEPSi  was  established  in  part  as  a  self-regulatory  alternative  to  measures  reflected  in  the 
current proposal.  Stakeholders implementing NEPSi have therefore indicated concern that the 
current  proposal may pose  a challenge to  industry participation in  self-regulation initiatives  in 
the future.  However, in addition to any recommendations of the NEPSi evaluation report, which 
shall  be  issued  by  the  European  Commission  in  Q2  2016,  it  should  be  noted  that  the 
effectiveness of this self-regulation initiative is hindered by the following: 

 

 

it does not apply to all sectors where exposure to RCS occurs, in particular not to the 
construction sector, which, has the largest burden of occupational cancer65; 
it is not binding and cannot therefore be enforced by national authorities. 

65  Rushton, L. et al. Occupation and cancer in Britain. Br J Cancer. 2010 Apr 27;102(9):1428-37 

27 

 
 
                                                 
Consequently,  the  NEPSi  agreement  and  any  similar  future  initiatives  would  be  an  important 
complementary measure but could not be as effective as OELs in setting and enforcing the same 
level of minimum protection across the EU and in all sectors of industry. 

C. Sector or industry specific OELs 

It could be envisaged that, where justified, sector, industry or use specific OELs could be set or 
derogations could be allowed for specific sectors, industries or uses for a defined time-period or 
subject to specific conditions. 

As  a  result  of  such  an  approach  we  would  have  different  minimum  standards  of  worker 
protection across the EU for the same type of work and the same chemical agent, which is not 
permissible in the context of binding OELs as established under the CMD.  

Further the process by which the tripartite ACSH agree their Opinion on appropriate EU OELs 
under CMD includes extensive consideration of socioeconomic and technical feasibility factors 
–  including  sector, industry  and  use-specific  concerns.    As a  result  these  concerns are  already 
reflected in the value supported by the ACSH and taken forward in the current proposal. 

This  option,  therefore,  had  to  be  discarded  as  the  current  legal  framework  does  not  provide  a 
legal basis for such provisions. 

Where an EU OEL is established, Member States and employers retain the right to implement 
more  protective  values  than  the  proposed  minimum  standards,  also  taking  into  account  the 
general CMD duty to substitute, eliminate or otherwise minimise exposures. 

D. Providing industry-specific scientific information without setting OELs 

Another option could be for the Commission to collect and provide industry-specific scientific 
information to support employers in complying with the CMD obligations.  

Apart  from  the  practical  difficulties  related  to  collection  of  relevant  data  for  the  multitude  of 
sectors  concerned,  it  is  considered  that  this  option  would  not  be  effective  in  achieving  the 
objectives of the initiative for the following reasons: 

 

the way the information is used by employers would not be enforceable by surveillance 
authorities; 

  such an option would not fit with the overarching legal framework of the CMD, which 
provides for general exposure management requirements to be specifically supplemented 
by EU-wide minimum standard OELs: 

 

in  some  cases,  extensive  industry-  and  chemical  agent-  specific  information  and 
guidance  already  exists  and  should  be  taken  into  account  by  employers  during  risk 
assessments – but this has not demonstrably addressed harmful exposures at EU level as 
identified in the IOM study. 

E. Market-based instruments 

Market-based  instruments  such  as  subsidies,  tax  breaks  or  reductions  of  social  insurance 
contributions,  are  sometimes  used  by  Member  States  to  incentivise  business  to  comply  with 
health  and  safety  rules.  Such  instruments  can  effectively  support  compliance  with  exposure 
limits.  However,  to  be  applied  effectively  in  this  context,  such  mechanisms  would  need  to  be 
linked  (directly  or  indirectly)  with  the  actual  levels  of  exposure  at  firm  level.  These  are 
generally not observed (as it also emerges from the analysis presented in Section 5 below), and 
improved  data  collection  would  likely  result  in  being  extremely  costly  and  cumbersome.  It 
should also be noted that these instruments remain in the hands of Member States and the extent 

28 

 
 
to which they are used vary significantly66. This option alone would therefore not be effective in 
ensuring the same level of minimum protection across the EU. 

F. Regulation under other EU instruments (REACH) 

As  detailed  in  section  2.3,  other  EU  regulatory  options  exist  for  managing  risks  to  workers 
associated with exposure to some chemical carcinogens – most notably REACH 'authorisation' 
or 'restrictions'. 

As previously indicated, REACH is a relevant regulatory instrument for protection of workers 
from hazardous chemicals, including in particular chemical carcinogens.  However, in the case 
of  the  present  proposal  CMD  is  the  more  appropriate  regulatory  instrument  for  the  following 
reasons: 

  Hardwood  dust  and  respirable  crystalline  silica,  which  are  process  generated  in  the 

workplace, are outside scope of REACH. 

  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. 

  REACH  sets  directly-acting  harmonised  standards  from  which  Member  States  cannot 
deviate  except  in  exceptional  (and  possibly  time  limited)  circumstances.  CMD  sets 
'minimum  standards'  which  allow  Member  States  to  maintain  or  implement  more 
protective measures – which is appropriate in the interest of worker protection. OELs are 
an example of this. 

  REACH places the onus of risk assessment on the supply chain, and is 'chemical agent 
specific'. CMD risk assessment is more likely to be workplace- and process-specific and 
should take into account aggregated exposure of workers to all occupational carcinogens. 
From the point of view  of preventing exposure to carcinogens CMD offers  therefore a 
more holistic approach to workplace risks. 

  REACH  authorisation  is  a  risk  management  measure  covering  all  risks  arising  from 
given intrinsic properties of a substance, including the risks for workers.  In the absence 
of explicit derogations it applies to all placing on the market for a use and use of subject 
chemical substances and so is a less targeted measure than a CMD OEL, which applies 
in the long-established OSH regulatory context and relates specifically to the workplace.  
REACH  authorisation  can  complement  CMD,  in  particular  by  strengthening  the 
substitution  principle  and  its  full  implementation,  as  well  as  driving  toward  additional 
risk management. 
It  should  also  be  noted  that,  as  it  is  based  on  social  policy  provisions  of  the  TFEU67, 
CMD reflects the role foreseen there for the social partners in establishing standards for 
worker protection. 

 

  OELs  are  an  important  part  of  CMD  and  of  the  wider  occupational  safety  and  health 
approach to managing chemical risks.  REACH, on the other hand, is not intended to set 
OELs. The concerned Commission services, Member States, and the social partners have 
all  expressed  their  view  that  OSH  Directives  are  the  appropriate  EU  legislative 
framework to establish limit values for the protection of workers. 

A  comparison  table  summarising  key  characteristics  of  the  CMD  and  REACH  approaches  to 
risk assessment and control of occupational carcinogens can be found in Annex 7 (14.2.3).                                                                                                          

66  European Agency for Safety and Health at Work. “Economic Impact of Occupational Safety and Health in the 

Member States of the European Union.” Available at https://osha.europa.eu/en/publications/reports/302 
67  Consolidated version of the Treaty on the Functioning of the European Union. OJ C 326, 26.10.2012.  

29 

 
                                                 
From the point of view of enterprises,  it is  important  to  note that  compliance costs associated 
with  workplace  legislation  (such  as  protective  measures  and  equipment)  directly  contribute  to 
better  risk  management,  and  that  administrative  costs  triggered  by  workplace  legislation  are 
relatively small. 

In 2015 an ongoing collaboration of 40 European sectoral and cross-sectoral associations, nine 
national  associations,  and  several  corporations,  all  with  interests  in  manufacturing,  importing, 
and  using  chemical  substances  began  actively  engagement  with  the  Commission  services  in 
order  to  ensure  more  efficient  risk  management  measures  that  can  combine  OSH  OELs  in 
addition  to  REACH  risk  management  options  as  the  more  proportionate  measure  where 
chemical risks identified during risk assessment relate principally to worker protection.68  The 
Commission services concerned are working with this 'Cross Industry Initiative'69 and to discuss 
the  relevance  of  their  proposals  in  the  operation  of  EU  chemicals  policies  regarding  worker 
protection. 

Targeted CMD OELs are appropriate for protecting workers from occupational exposure to the 
chemical carcinogens subject to the present proposal. The synergies in the relationship between 
CMD and REACH provide further opportunities for regulatory measures as appropriate. 

It  should  be  noted  that  this  impact  assessment  does  not  aim  to  assess  whether  REACH  risk 
management measures are proportionate and effective. The present proposal does not preclude 
relevant  REACH  measures  from  being  proposed  where  this  is  justified,  and  in  some  cases  a 
combination  of  CMD  OELs  and  other  regulatory  (or  non-regulatory)  risk  management 
measures, including under REACH, may be justified. 

4.3  Options retained for consideration 

Identification process 

Reviewing  or  setting  new  OELs  under  CMD  follows  a  specific  procedure  involving  seeking 
scientific  advice  and  consulting  the  ACSH.  Article  16  of  the  CMD,  which  states  that 
scientific/technical  data  should  be  included  in  the  basis  on  which  OELs  are  set,  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).70 

68  Recommendations  by  an  EU-wide  cross-industry  initiative  for  better  regulation  in  chemicals  management, 

position paper, November 2015. 

69  Position 

paper 

available 

at: 

http://ec.europa.eu/smart-regulation/refit/refit-

platform/docs/submissions/cii_enhancing_the_effectiveness_of_osh_310715_en.pdf 

70 See “Figure 3. Simple representation of EU OEL setting procedure” (annex 9).  

30 

 
                                                 
Figure 3.  Simple representation of EU OEL setting procedure 

The 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.71 

SCOEL  carry  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.  SCOEL procedures 
for  the  adoption  of  a  Recommendation  by  SCOEL  include  an  external  consultation  with 
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. 

The  Advisory  Committee  on  safety  and  health  at  work  (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  Committee's  remit  is  to  assist  the  European  Commission  in  the 
preparation,  implementation  and  evaluation  of  activities  in  the  fields  of  safety  and  health  at 
work.  The  Committee  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 – also tripartite but with smaller selected expert membership.  
The Working Party on Chemicals (WPC) serves the ACSH according to a mandate agreed by 
the plenary Committee, and in particular undertakes detailed technical and policy negotiation of 
EU limit values as well as broader chemicals policy support for the ACSH and Commission. 

The  ACSH  discusses  adopted  SCOEL  Recommendations  (and/or  other  appropriate  scientific 
evidence) and adopts a formal Opinion on what, in practice, is considered to be achievable by 
employers whilst ensuring that workers' health is adequately protected. 

71  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 

31 

 
 
                                                 
In the case of the carcinogens considered in this report, SCOEL concluded recommendations on 
all  but  two.72,  73  Table  1  in  Annex  5  sets  out  the  status  of  relevant  adopted  SCOEL 
recommendations. 

While the aim of ensuring the protection of the health of workers is maintained, binding OELs 
set under CMD are usually based on factors beyond the independent scientific advice, because 
they must also reflect other factors such as 'feasibility' and taking into account the views of the 
social partners. 

Amending the CMD can therefore only be proposed after a two-stage consultation of the social 
partners (management and labour) in accordance with Article 154 TFEU. This consultation took 
place in 2004 and 2007 and addressed the following elements: the possibility of extending the 
scope of the Directive to include reprotoxic substances, the revision of existing OELs and the 
establishment  of  new  ones  for  more  substances,  need  to  develop  a  EU-wide  methodology  for 
carcinogens and mutagens OELs setting, and the need to improve the training and information 
requirements for workers. 

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. 

The consultation process resulted, amongst others, in the support of the following: 

 

 
 

to bring a limited number of so-called process generated substances (PGSs) under the 
scope of the Directive by including them in Annex I, 
to revise existing OELs in Annex III in the light of most recent scientific data, and  
to add additional OELs for a limited number of substances in Annex III where available 
information, including scientific and technical data supports this. 

The ACSH, in an Opinion adopted in December 2012, and in supplementary Opinions adopted 
in May 2013 and November 2013, confirmed (with a few dissenting opinions) the OELs initially 
developed by the SCOEL (where relevant) and approved inclusion of these into CMD. 

The  three  adopted  ACSH  Opinions  include,  where  necessary,  specific  comments  from  the 
interest  groups  (the  social  partners  and  Member  States)  which  broadly  reflect  the  principal 
points  maintained  by  each  interest  group  throughout  discussions  of  the  Working  Party  on 
Chemicals (WPC). In many cases there are no specific comments as there was a consensus view 
of the three interest groups. As such, the final ACSH Opinions should be taken as representative 
of the views of stakeholder groups represented. 

In  addition,  the  amendment  of  the  CMD  is  routinely  discussed  at  meetings  of  the  tri-partite 
WPC. Following adoption of the three ACSH Opinions  this discussion has primarily focussed 
on  the  state  of  play  and  timing  of  the  next  steps  of  the  planned  amendment  of  the  Directive. 
They have not expressed additional views on the content of the adopted opinions. 

In  principle,  revision  of  the  Annexes  should  be  conducted  on  regular  basis,  as  soon  as  new 
scientific data is available and the technical feasibility of introducing new or revised OELs has 
been  established.  The  duration  of  the  current  preparatory  work  reflects  that  it  is  a  first 

72  The two exceptions are 2 nitropropane and o-toluidine. 
73  In December 2015, reflecting scientific developments and updated working procedures, SCOEL was mandated 
to further consider five of these 13 agents:  respirable crystalline silica, chrome (VI) compounds, hydrazine, o-
toluidine, 2 nitropropane.  Ongoing SCOEL work may, in due course, influence the present or future proposals 
for limit values for the chemical agents concerned. 

32 

 
                                                 
preparation of a proposal for a relatively large number of new/revised limit values. Appropriate 
modes of cooperation between all the concerned actors as well as working methods within the 
advisory bodies had to be developed. 

It is expected that the procedures and working methods described above and established in the 
course  of  the  current  exercise  will  give  a  good  basis  to  complete  preparatory  steps  leading  to 
eventual future revisions of the CMD in a much shorter time. The fact that a second proposal for 
the  introduction  of  OELs  for  additional  chemical  agents  may  be  presented  in  the  near  future 
should  be  seen  precisely  as  a  step  of  a  continuous,  regular  process  of  updating  of  the  CMD, 
where necessary. 

Identified options 

The Table 3 below summarises options for different OELs for each of the 13 chemical agents. 

A baseline scenario of no further EU action is Option 1 for each chemical agent represented in 
this initiative. 

As  explained  above,  for  each  of  the  chemical  agents  scientific  and  technical  data  has  been 
considered  and  discussions  at  the  ACSH  have  taken  place,  resulting  in  values  to  be  proposed 
into co-decision as an OEL. Directly adopting the values agreed by the ACSH forms Option 2 
for each chemical agent. 

Where appropriate and depending on specific characteristics of  the agents, flanking options to 
either  propose  a  OEL  which,  compared  with  the  ACSH  value,  is  lower  (theoretically  more 
protective  of  worker  health)  or  higher  (theoretically  less  protective  of  worker  health)  are  also 
presented as Option 3 and/or 4 respectively for each chemical agent. 

These  flanking  values  are  drawn  from  the  IOM  Study,  for  which  they  were  established  by 
preference:  i)  from  a  SCOEL  Recommendation  if  available;  ii)  as  values  reflecting  available 
data  (for  example  taking  account  of  existing  national  OELs);  or  iii)  on  the  basis  of 
recommendations from the contractor (for example taking into account non-EU OELs). Where 
available data do not support setting a lower or higher OEL than the ACSH value, these options 
are  discounted.    Further  detailed  information  regarding  the  source  of  these  additional  options 
may be found in the relevant IOM Study reports for each of the chemical agents in question. 

In  the  case  of  RCS,  options  2,  3  and  4  include  the  possibility  of  inclusion  in  the  Annex  I  of 
CMD along with OEL proposals under Annex III. 

In  addition,  for  each  chemical  agent  where  SCOEL  has  identified  significant  risk  of  adverse 
systemic affects resulting from dermal uptake a 'skin notation' ('sk.') is indicated alongside the 
numerical OEL. 

Table 3.  Options matrix 

Name and CAS 
no. of the 
chemical agent 
where relevant 

Option 1 
(baseline 
- existing 
OEL) 

Option 2 
(ACSH opinion) 
(ppm – parts per 
mln, mg/m3 or 
f/ml - fibres per 
ml) 

Option 3 
(more stringent) 
(ppm – parts per 
mln, mg/m3 or f/ml - 
fibres per ml) 

Option 4 
(less stringent) 
(ppm – parts per 
mln, mg/m3 or f/ml - 
fibres per ml) 

1,2 Epoxypropane 
(propylene oxide) 
75-56-9 
1,3 Butadiene 
106-99-0 
2-Nitropropane 
79-46-9 

none 

none 

none 

1 ppm 
(2.4 mg/m3) 

1 ppm 
(2.2 mg/m3) 
5 ppm 
(18 mg/m3) 

n/a 

0.5 ppm 
(1.1 mg/m3) 
n/a 

33 

5 ppm 
(12 mg/m3) 

5 ppm 
(11 mg/m3) 
n/a 

 
Name and CAS 
no. of the 
chemical agent 
where relevant 

Option 1 
(baseline 
- existing 
OEL) 

Option 2 
(ACSH opinion) 
(ppm – parts per 
mln, mg/m3 or 
f/ml - fibres per 
ml) 

Option 3 
(more stringent) 
(ppm – parts per 
mln, mg/m3 or f/ml - 
fibres per ml) 

Option 4 
(less stringent) 
(ppm – parts per 
mln, mg/m3 or f/ml - 
fibres per ml) 

Acrylamide 
79-06-1 
Hardwood dust 
Chromium (VI) 
compounds 
Ethylene oxide 
75-21-8 

o-Toluidine 
95-53-4 
Refractory 
Ceramic Fibres 
(RCF) 
Respirable 
crystalline silica 
(RCS) 

Vinyl chloride 
monomer 
75-01-4 
Bromoethylene 
(Vinyl bromide) 
593-60-2 
Hydrazine  
302-01-2 

none 

5 mg/m3 
none 

0.1 mg/m3 
Sk. 
3 mg/m3 
0.025 mg/m3 

0.03 mg/m3 
Sk. 
1 mg/m3 
n/a 

n/a 

n/a 
0.05 mg/m3 

none 

none 

none 

none 

3 ppm 
(7.8 
mg/m3) 
none 

none 

1 ppm 
(1.8 mg/m3) 
Sk. 
0.1 ppm 
(0.5 mg/m3) 
0.3 f/ml  

n/a 

n/a 

n/a 
0.1 f/ml 

1 ppm 
(5 mg/m3) 
1 f/ml 

Include in Annex I 
and establish an 
OEL of 0.1 mg/m3 
in Annex III 
1 ppm 
(2.6 mg/m3) 

Include in Annex I and 
establish an OEL of 
0.05 mg/m3 in Annex 
III 
n/a 

Include in Annex I 
and establish an OEL 
of 0.2 mg/m3 in 
Annex III 
2 ppm 
(5.2 mg/m3) 

1 ppm 
(4.4 mg/m3) 

0.01 ppm 
(0.013 mg/m3) 
Sk. 

n/a 

n/a 

5 ppm 
(22 mg/m3) 

0.1 ppm 
 (0.13 mg/m3) 
Sk. 

The  next  section  presents  an  analysis  of  impacts  of  the  different  policy  options  for  each 
chemical agent. For reasons of space the analysis for each chemical agent is contained in a table 
which is the basis of the comparison ratings presented74. 

Unless  otherwise  specified  all  data  in  the  agent-specific  analysis  comes  from  the  IOM  study, 
with reference periods as specified in that study. 

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

COMPARE? 

Before looking at the comparison between different policy options, it should firstly be noted that 
the  standards  of  legal  control  established  in  the  CMD  are  strict  for  all  in-scope  carcinogens, 
whether or not entries in Annex I (process generated substances) or Annex III (OELs) have been 
established or amended. 

The proposed amendments are thus intended to enhance worker protection by improving clarity 
for employers and enforcers. The inclusion of chemical agents in Annex I (the list of 'process-

74  The comparison table uses 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. 

34 

 
 
 
 
 
 
 
                                                 
generated substances') confirms that they fall in scope of the Directive control provisions. OELs 
set  out  in  Annex  III  establish  clear  compliance  benchmarks  for  exposure  control.  These 
considerations will be inherent in any investment decision, profit projection etc. and should be 
based on as much legal clarity as possible. 

Concretely, comparing the different policy options requires estimating the effects of introducing 
new  or  more  stringent  OELs  for  the  chemical  agents  under  consideration.  The  methodology 
followed can be summarised as follows: 

 

In  general,  the  introduction  of  an  OEL  is  expected  to  determine  a  reduction  in  the 
occupational  exposure  to  the  carcinogen  concerned  (as  full  compliance  with  the 
proposed  new  OEL  is  assumed).  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 OEL ("Baseline scenario", corresponding to Option 1). 

  For  a  given  reduction  in  exposure  levels,  it  is  then  necessary  to  estimate  the  expected 
decrease  in  the  incidence  of  cancer  cases  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 health benefits of avoided cancer registrations and deaths can then be expressed in 
monetary terms by applying standard evaluation methods (value of life years lost, cost of 
illness, willingness to pay to avoid cancer). 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. This methodology is further explained in Annex 4. 

A number of issues need to be taken into consideration in order to better understand the figures 
and conclusions presented in the following sections, which are mostly derived from the results 
of the IOM study. As set  out above, the CMD requires employers to take measures  to  protect 
workers from occupational use of carcinogens. All stakeholders as consulted in the ACSH are in 
favour of the proposed legislative initiative albeit with some differences regarding appropriate 
OEL values. 

In  terms  of  cost  and  benefit  projection,  this  renders  the  updating  of  the  CMD  particularly 
complex;  independent  of  further  clarity  under  the  CMD,  employers  will  include  more  or  less 
stringent protection of workers in their facilities, e.g. costly industrial ventilation combined with 
personal  protective  gear.  Furthermore,  Member  States  with  substantial  production  involving  a 
certain  carcinogenic  chemical  agent  are  likely  to  introduce  national  OELs  irrespective  of  EU 
action. 

In order to take proper account of the cancer latency period (which the IOM study assumes to be 
of  10-50  years  for  solid  tumours  and  of  0-20  years  for  haematopoietic  neoplasms),  the  future 
cancer burden is estimated over a 60 years period.  

Looking at the methodological challenges in more detail: 

  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.75 Where exposure data is available, its use as an evidence 

75  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 

35 

 
 
                                                 
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.76 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  neurotoxicity,  severe  skin  damage,  respiratory  diseases  or 
renal toxicity). 

  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, 
based  on  a  constant  discount  rate  of  4%,  have  been  recalculated  applying  a  declining 
discount rate (4% for the first 20 years, 3% thereafter) in line with the most recent better 
regulation guidelines. 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). 

To allow for a better comparison between net health benefits and net 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 

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. 

76  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 

36 

 
                                                                                                                                                            
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  201377. 
The outcome of this work is expected to contribute to a better definition of the baseline situation 
for possible future initiatives on developing OELs for other priority occupational carcinogens. 

Analysis of impacted Member States and proportionality 

For each of the 13 carcinogens, an analysis of the need for and benefit of action at the EU level 
is presented by chemical agent in the following sub-sections (and in Annex 9). 

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 currently  in place  at  national  level is provided in Annex 9, as  well as the estimated 
number  of  workers  potentially  exposed  by  Member  State.  Similar  information  is  also 
summarised in  Table 4 in  Annex 6, which identifies the population of workers occupationally 
exposed  to  each  chemical  agent  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. 

This analysis bears the condition that reliable exposure data is scarce. In particular it should be 
noted that it is not possible to identify the proportion of workers in each Member State who may 
be  employed  in  tasks  where  closed  system  or  effective  exposure  controls  are  already  either 
eliminating  or  reducing  exposures  below  the  level  represented  by  the  OELs  recommended  by 
ACSH. The probable over-estimation of exposed populations resulting from this data scarcity is 
likely to be mitigated by the converse inability to identify specific populations of workers who 
may experience exceptionally high exposures. 

5.1  1,2 Epoxypropane  

This  chemical  agent  is  associated  with  lymphopoietic  cancer,  haematopoietic  cancer  and 
increased leukaemia risk. 

The major use of this chemical agent is to make 1,2 epoxypropane polymers that are used in the 
manufacture  of  polyurethane  foams.  Its  second  most  important  use  is  in  the  production  of 
propylene  glycol.  About 5%  of all  1,2 Epoxypropane  production  is used in  a  diverse range of 
applications such as the manufacture of surfactants and as a stabiliser for dichloromethane. 

The  productive  capacity  within  the  EU  is  2.75  mln  tonnes  per  year  and  it  is  produced  in  14 
facilities in eight Member States (BE, FR, DE, NL, PL, SK, ES and RO). There are estimated to 
be 150-300 user facilities across the EU. 

Between  35-70  EU  workers  are  estimated  to  be  exposed  to  1,2  epoxypropane  during  its 
manufacture and between 450-1,500 EU workers in the chemical industry. 

Table 4.  1,2 Epoxypropane – Types of impacts 

77  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. 

37 

 
 
 
                                                 
Impact  Option 1 

Baseline: No OEL 

Option 2 
OEL of 1 ppm (2.4 mg/m3)78 

Option 3 
 OEL of 5ppm (12 mg/m3) 

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- 

Costs of compliance not 
significant (€1-2k). Few if any 
enterprises would require some 
additional control measures to 
meet the OEL. Any enterprises 
that do not currently comply 
would need to implement 
relatively low-cost measures. 

No significant impacts v-à-v 
the baseline are expected as 
exposure is already largely 
below this OEL as the vast 
majority of investment 
required by industry to comply 
with this OEL already 
occurred.  

Health costs are estimated 
between 2.5-10.7 €mln. 

100 attributable YLLs and 110 
DALYs during 2010-2069 
period. 79,80 

Small cost saving (e.g. a few 
€k) from avoided health care 
and reduced cost of illness due 
to reduction in YLLs.  

Expected health benefits 
mainly in the downstream use 
sector, which are expected to 
be a share of total health costs 
under baseline scenario. 

No additional health costs or 
benefits. 

There may be some 
environmental impacts related 
to humans exposed via the 
wider environment, rather than 
costs associated with damage 
to e.g. ecosystems. 

No change compared to 
baseline (measures relate to 
training and employee 
supervision rather than any 
additional engineering 
controls). 

No change compared to 
baseline. 

Estimates  of  exposure  levels  were  based  on  samples  obtained  during  manufacturing  and 
downstream  use  in  7  facilities.  According  to  these  estimates  most  companies  already  comply 
with a level of 1 ppm. For those that do not yet comply, the additional costs are expected to be 
very low. It is therefore assumed that the introduction of an OEL of 1 ppm would not imply any 
important costs associated with compliance, neither major social, macro-economic or significant 
environmental impact. 

the  ACSH  discussions  employers'  representatives  noted 

During 
in  routine  and 
manufacturing practices workers' exposures are already well below an OEL of 2 ppm and that a 
level of 1 ppm during maintenance and loading operations could be ensured through breathing 
personal protective equipment. 

that 

Introduction of an OEL of 1 ppm can be expected to be more effective in reducing exposure to 
1,2 epoxypropane compared to the baseline, however the monetised health benefits are minor. 

Table 5.  1,2 Epoxypropane – Comparison of options 

Criteria 

Baseline 

Option 2 (1 ppm) 

Option 3 (5 ppm) 

Effectiveness 

0 

≈ 

≈ 

78  The study did not assess directly impacts of introducing an OEL of 1 ppm. However, it concluded that impacts 

identified for an OEL of 2 ppm would apply equally to an OEL of 1 ppm. 

79  YYL - Years of Life Lost, DALY - Disability Adjusted Life Years – see Annex 4 for further explanation. 
80  According to the IOM Research Project, less than one death per year is predicted from past or future exposure - 

100 attributable YLLs during 2010-2069 period. 

38 

 
 
 
 
 
 
 
 
 
 
                                                 
Efficiency 

Coherence 

Scientific advice 
(SCOEL) 

ACSH 

0 

0 

1 ppm  

1 ppm  

≈ 

+ 

≈ 

≈ 

The  scientific  advice  and  the  opinion  of  the  social  partners  and  Member  States  in  the  ACSH 
support option 2, and the CMD further establishes an expectation that OELs be set where it is 
possible to do so. 

Impact on MS and proportionality 

In the case of 1,2 epoxypropane, 26 Member States have so far opted either to not to set a limit 
or to set one which is less protective of worker health than the value recommended by ACSH. 
Figure 4 in Annex 9 illustrates the ranges of existing national OELs compared to Option 2. 

Member  States  where  the  production  of  this  chemical  agent  is  concentrated  (such  as  BE,  DE, 
ES,  FR,  NL,  PL,  RO  and  SK))  have  no  OEL  or  OELs  above  the  proposed  limit  value. 
Introducing  an  OEL  would  bring  a  greater  clarity  for  economic  operators  across  the  EU  and 
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 an OEL of 1 ppm would require changes to the national frameworks of most 
MS.  Due  to  the  generally  low  number  of  exposed  workers  across  the  EU,  no  estimates  were 
made about the numbers of exposed workers in those 26 MS. Even if current exposure levels in 
the EU are estimated to be well below 2 ppm, a minimum basis of protection against the risks 
arising from workers' exposure to these carcinogens cannot be ensured under the baseline for all 
EU  workers  –  it  follows  that  an  action  taken  at  the  European  Union  level  to  achieve  this 
objective is proportionate. 

5.2  1,3 Butadiene 

This  chemical  agent  is  associated  with  an  increased  risk  of  lymphohaematopoietic  cancer, 
mainly lymphosarcoma. 

Most  1,3  butadiene  is  polymerized  at  a  relatively  small  number  of  sites  in  Europe  to  form 
synthetic  rubber.  It  is  also  used  as  a  chemical  intermediate  in  the  production  of  neoprene  for 
automotive  and  industrial  rubber  goods,  in  the  production  of  methylmethacrylate-butadiene-
styrene polymer, which is used as a PVC reinforcing agent, and in the production of adiponitrile 
(a nylon precursor). The production capacity in the EU is estimated to be 2.9 mln tonnes. 

There  were  nine  plant  sites  producing  emulsion  of  SBR  in  July  2010  (IOM  report),  four 
producing  solution  of  SBR,  seven  producing  polybutadiene  or  butadiene  rubber  and  six 
producing nitrile butadiene rubber. Some of the sites produce two or more of these elastomers at 
the same location. All companies affected by the proposed OEL value of 1ppm would be SMEs, 
and the great majority of them (about 90%) would be microenterprises (less than 10 employees). 

About 27,600 workers in the EU are estimated to be potentially exposed to this chemical agent. 

39 

 
 
 
 
 
 
 
Table 6.  1,3 Butadiene – Types of impacts 

Impact  Option 1 

Option 2 

Option 3 

Option 4 

Baseline: No OEL 

OEL of 1 ppm 
(2.2 mg/m3) 

OEL of 0.5 ppm  
(1.1 mg/m3) 

OEL of 5 ppm  
(11 mg/m3) 

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It is estimated that less 
than 0.3% of enterprises 
(19 enterprises) will 
require some form of 
control measure to meet 
the proposed OEL.  

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 
0.7-4.4 mln €. 

No plant closures foreseen. 

Estimated health benefits 
in addition to those under 
baseline are between 0 to 
0.1 mln €. 

No  avoided  deaths  or 
cancer registrations, but 10 
more  YLLs  and  20  more 
DALYs  estimated  over 
2010-2069 
period 
compared to baseline.   

Behavioural change 
amongst employees and 
updating health and safety 
training will be required. 

A 7% annual 
decline in exposure 
levels assumed, so 
that by 2030 90% 
of high exposed 
jobs estimated to 
be below 0.6 ppm.  

It is estimated that 
2% of enterprises 
(159 enterprises) 
will require some 
form of control 
measure to meet 
the proposed OEL.  

It is estimated that 
4% of enterprises 
(251 enterprises) 
will require some 
form of control 
measure to meet 
the proposed OEL.  

Costs are expected 
due to further 
spending on 
control measures 
to reduce exposure 
(e.g. improving 
working practice, 
improved 
ventilation, 
improved loading/ 
unloading 
equipment). 

Estimated health 
costs between 41 
€mln (low 
scenario) and 167 
€mln (high 
scenario) in the 
period 2010-2069. 

YLLs: 1,320 

DALYs: 1,640 

personnel 
Some 
may  change  their 
working  practices 
(e.g. 
wearing 
respiratory 
protective 
equipment) 
reduce 
inhalation 
exposure. 

to 
risks  of 

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 5.8 - 
37.8 mln €. 

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 9.2-
59.9 mln €. 

No plant closures 
foreseen. 

No plant closures 
foreseen. 

Estimated health 
benefits in addition 
to those under 
baseline are 
between 0.2 to 0.6 
mln €. 

Estimated health 
benefits in addition 
to those under 
baseline are 
between 0.2 to 0.6 
mln€. 

No avoided deaths 
or cancer 
registrations, nor 
changes in 
DALYs, but 10 
less YLLs 
estimated over 
2010-2069 period 
compared to 
baseline.  

Behavioural 
amongst 
change 
employees 
and 
updating health and 
safety  training  will 
be required. 

No avoided deaths 
or cancer 
registrations, but 
20 less YLLs and 
10 less DALYs 
estimated over 
2010-2069 period 
compared to 
baseline.  

 Behavioural 
amongst 
change 
and 
employees 
updating 
health 
and  safety  training 
will be required. 

40 

 
 
 
 
 
 
Impact  Option 1 

Option 2 

Option 3 

Option 4 

Baseline: No OEL 

OEL of 1 ppm 
(2.2 mg/m3) 

OEL of 0.5 ppm  
(1.1 mg/m3) 

OEL of 5 ppm  
(11 mg/m3) 

As in option 2. 

As in option 2.  

Not estimated. 

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Possibly more 
direct emissions 
(through 
ventilation) but 
overall 
environmental 
burden should not 
increase. 

The  exposure  levels  were  estimated  across  the  industries  of  manufacture  of  refined  petroleum 
products  and  manufacture  of  rubber.  The  estimates  of  exposure  levels  in  the  manufacture  of 
refined petroleum products (NACE code 23) were based on different studies covering Finland, 
13 EU countries, EU and UK. The estimates of exposure levels in the rubber industry (NACE 
code  251)  were  based  on  studies  in  27  EU  plants,  in  the  Netherlands,  Finland  and  Czech 
Republic. 

Given the estimated decreasing exposure levels to 1,3 Butadiene in the baseline scenario and the 
fact  that  it  is  not  possible  to  identify  an  exposure  level  at  which  there  is  no  risk  of 
lymphohaematopoietic  cancer,  none  of  the  assessed  options  would  allow  a  reduction  in  the 
numbers  of  attributable  deaths  or  cancer  registrations  in  the  2010-2069  period.  However, 
introducing  an  OEL  would  be  effective  in  ensuring  a  greater  clarity  for  economic  operators 
across the EU. Option 4 is the least effective as it is estimated to slightly increase the number of 
years of life lost (YLL) over the 2010-2069 period as compared to the baseline scenario, while 
YLL  are  expected  to  slightly  decrease  under  options  2  and  3.  Of  those  two,  option  2  brings 
about the least additional costs for enterprises. 

Employers'  representatives  at  the  ACSH  accepted  the  option  of  an  OEL  of  1  ppm  as  feasible 
while  expressing  concerns  about  potential  economic  impacts  of  lowering  an  OEL  below  that 
level. 

Table 7.  1,3 Butadiene – Comparison of options 

Criteria 

Baseline 

Option 2 

Option 3 

Option 4 

Effectiveness 

Efficiency 

Coherence 

0 

0 

0 

1 ppm 

≈/+ 

- 

+ 

0.5 ppm 

5 ppm 

+ 

-- 

+ 

≈ 

≈ 

≈ 

Scientific advice 
(SCOEL) 

Additional leukaemia risk with 1ppm exposure for a 40-year working life: from 
0 to 10.78 extra leukaemia deaths between ages 25-85 years.  

ACSH 

1 ppm (=2.25 mg/m3) to be reviewed. A revision to be conducted in 3 years. 

The opinion of the social partners and Member States in the ACSH supports option 2, and the 
CMD  further  establishes  an  expectation  that  OELs  be  set  where  it  is  possible  to  do  so. 
Introducing  an  OEL  would  also  be  effective  in  introducing  a  greater  clarity  for  economic 
operators across the EU. An OEL of 1 ppm is also set in the US. 

Impact on Member States and proportionality 

41 

 
 
 
 
In the case of 1,3 Butadiene 23 Member States have no OEL or one that is less stringent than the 
ACSH recommended 1 ppm level. Figure 5 in Annex 9 illustrates the ranges of existing national 
OELs  compared  to  Option  2.  The  following  Figure  6  shows  distribution  of  exposed  workers 
across the Member States. 

The Member States where the production or use of this substance is concentrated (such as DE, 
FR,  UK,  ES,  PL,  RO)  have  no  OEL  or  OELs  above  the  proposed  limit  value.  Introducing  an 
OEL would bring a greater clarity for economic operators across the EU and 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  an  OEL  of  1  ppm  would  require  changes  for  a  substantial  number  of 
Member States. It is estimated that approximately 93% of exposed workers are located in those 
23 Member States. Even if current exposure levels in the EU are estimated to be well below 2 
ppm,  a  minimum  basis  of  protection  against  the  risks  arising  from  workers'  exposure  to  these 
carcinogens cannot be ensured for all EU workers under the baseline scenario – it follows that 
an action taken at the European Union level to achieve this objective could be justified. 

5.3  2 Nitropropane 

According to animal toxicity studies 2 nitropropane may cause liver tumours in humans. 

Occupational  exposures  to  this  chemical  agent  occur  primarily  in  its  production  and  use  as  a 
solvent  in  inks,  adhesives,  paints  and  coatings.  It  is  produced  in  relatively  low  volumes. 
According  to  the  IOM  report  there  was  only  one  plant  in  Germany  which  produced  2-
nitropropane.  In  downstream  uses  exposures  were  considered  only  likely  to  occur  in  the 
manufacture of aircraft and spacecraft (NACE code 35.3) and possibly at very low levels in the 
recycling of non-metal waste and scrap (NACE code 37.2). 

No information on EU total production is available. 

About 51,400 EU workers are estimated to be exposed to 2 nitropropane. 

Table 8.  2 Nitropropane – Types of impacts 

Impact  Option 1 

Baseline: No OEL 

Option 2: 
OEL of 5ppm (18.25 mg/m3) 

It is assumed that exposures will fall by 7% 
per year in the future. Therefore, there are 
expected to be some costs for firms to put into 
place employee training, PPE and ventilation 
measures to reduce inhalation and dermal 
exposure. 

No significant additional costs for firms since 
under the baseline scenario it is estimated that 
firms are already achieving exposures below 5 
ppm. Neither additional health costs nor 
benefits are expected, as exposure is already 
estimated to be below an OEL of 5 ppm. 

Not possible to estimate health impact as there 
of 
no 
is 
evidence 
carcinogenicity 
humans.  However, 
probably low, considering low and decreasing 
exposure in the EU. 

epidemiological 
in 

None,  as  exposure  already  estimated  to  be 
below the possible OEL. 

No significant. 

No significant. 

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Estimates  of  exposure  were  assumed  to  decrease  by  7%  per  annum  (reference:  Creely  et  al. 
2007).  The  estimates  for  2010  exposures  were  based  on  worst-case  measurements 
obtained/reported  in  1984  from  the  industries  of  manufacture  of  2-nitropropane  and  of 
automotive manufacturing. 

Given  the  estimated  low  exposure  levels  (it  is  likely  that  no  worker  in  the  EU  is  exposed  in 
excess of the proposed limit value of 5 ppm), option 2 is expected to have no health impact. For 
the same reason, establishing this OEL at EU level would not impose additional costs on firms, 
while remaining a measure in terms of promoting a levelled playing field for companies across 
the EU. 

Table 9.  2 Nitropropane – Comparison of options 

Criteria 

Effectiveness 

Efficiency 

Coherence 

Scientific advice 
(SCOEL) 

ACSH 

Option 1 

Baseline 

0 

0 

0 

Option 2  

5 ppm 

≈ 

≈ 

+ 

SCOEL advice is currently being developed. 
IOM Study considered 5 ppm (18 mg/m3) for assessment, as 'typical' values 
for existing national OELs in the EU. 
5 ppm (=18.25 mg/m3)  

The opinion of the social partners and Member States in the ACSH supports option 2, and the 
CMD  further  establishes  an  expectation  that  OELs  be  set  where  it  is  possible  to  do  so. 
Introducing  an  OEL  would  also  be  effective  in  introducing  a  greater  clarity  for  economic 
operators across the EU. 

Impact on Member States and proportionality 

In the case of 2 Nitropropane 14 Member States have so far opted either to not to set a limit or 
to set one which is less protective of worker health than the value recommended by ACSH. The 
Figure 7 in Annex 9 illustrates the ranges of existing national OELs compared to Option 2. The 
following Figure 8 shows distribution of exposed workers across the Member States. 

Some of the Member States where production or use of this chemical agent is concentrated and 
therefore  where  the  numbers  of  exposed  workers  are  the  highest  (such  as  DE,  FR,  PL  or  IT) 
have  no  OEL  or  OELs  above  the  proposed  limit  value.  UK  and  ES  have  OELs,  which  are 
slightly  higher  than  Option  2.  Introducing  an  OEL  would  bring  a  greater  clarity  for  economic 
operators across the EU and 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.81 

Introduction of an OEL of 5 ppm would require changes for a substantial number of MS. It is 
estimated that approximately 62% of exposed workers are located in those 14 Member States. 
Even if current exposure levels in the EU are estimated to be below 5 ppm, a minimum basis of 
protection  against  the  risks  arising  from  workers'  exposure  to  these  carcinogens  cannot  be 
ensured  for  all  EU  workers  under  the  baseline  scenario.  It  follows  that  an  action  taken  at  the 
European Union level could be justified. 

81 See Figure 7 - 2 Nitropropane – Current national OELs vs. Option 2 ; and Figure 8 - 2 Nitropropane –Number of 

exposed workers 

43 

 
 
 
                                                 
5.4  Acrylamide 

Acrylamide  may  cause  pancreatic  cancer,  and  is  also  a  skin  irritant  and  may  be  a  tumour 
initiator in the skin, potentially increasing risk for skin cancer. 
99% of acrylamide in the EU is used in the production of polyacrylamide82. The main uses of 
polyacrylamide are in wastewater treatment, paper and pulp processing and mineral processing. 
Three companies are reported as producing acrylamide within the EU (in UK, Germany and the 
Netherlands). There were also thought to be firms in Spain, Finland and Italy who either supply 
(from  imports)  or  produce  acrylamide.  The  total  plant  capacity  within  the  EU  is  estimated  at 
between  80,000-150,000  tonnes  per  annum.  The  IOM  report  found  seven  producers  of 
polyacrylamide within the EU (two of which also produced acrylamide), as well as a number of 
smaller producers throughout the EU. 

54,000 EU workers are estimated to be exposed to acrylamide. 

It should be noted that the global market for polyacrylamide has been growing and is expected 
to continue expanding.83 

Table 10. Acrylamide – Types of impacts 

Impact 

Option 1 

Baseline: no OEL 

Exposures expected to 
continue falling by 10.5% 
per year in the manufacture 
of chemicals and chemical 
products sector.  

Option 2 
OEL of 0.1 mg/m3, Sk. 

Option 3 
OEL of 0.03 mg/m3, Sk. 

No additional economic 
costs, since industry already 
expected to comply with an 
OEL of 0.1 mg/m3.  

No additional economic costs, 
since industry already expected to 
comply with an OEL of 0.03 
mg/m3.  

Total health costs estimated 
at €156-326mln. 

Total attributable deaths 
between 2010-2069: 230  

Total attributable deaths between 
2010-2069: 230 

Total attributable deaths 
between 2010-2069: 230 

YLLs between 2010-2069: 
3,410  

YLLs  between  2010-2069: 
3,410 

DALYs between 2010-
2069: 3,480 

DALYs 
2069: 3,480 

between 

2010-

No additional health 
benefits expected as 
compared to the baseline 
scenario, since industry 
already expected to be 
complying with this OEL. 

YLLs between 2010-2069: 3,410 

DALYs between 2010-2069: 
3,480 

No additional health benefits 
expected as compared to the 
baseline scenario, since industry 
already expected to be complying 
with this OEL. 

No change. 

No change. 

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Estimates of exposure levels are based on a study by Bull et al. (2005), who monitored personal 
inhalation and dermal exposure at a UK acrylamide and polyacrylamide manufacturing facility, 
based on measurements between 1992 and 1995. The results of this study were extrapolated to 

82  It  should  be  noted  that  a  targeted  REACH  restriction  applies  to  placing  on  the  market  or  use  of  acrylamide 
(above a certain concentration) in grouting applications, which is prohibited.  While this restriction is relevant 
for  worker  protection,  it  should  not  be  expected  to  significantly  affect  the  overall  exposure  patterns  and 
associated cost benefit assessments made in this report. 

83 See Figure 9 – Acrylamide -  Global polyacrylamide market, 2012-2019 (in 1,000 tonnes) (Annex 9). 

44 

 
 
 
 
 
 
 
 
                                                 
the whole acrylamide and polyacrylamide manufacturing industry in the baseline scenario even 
if the 10.5% annual decline rate appears optimistic. 
On this basis it is assumed that industry is already complying with an OEL of 0.03 mg/m3, and 
thus no major health impact is to be expected from any of the two options. No economic cost is 
expected  for  the  implementation  of  any  of  both  options,  although,  if  any,  this  would  be  even 
lower for an OEL of 0.1 mg/m3 compared to a more stringent OEL of 0.03 mg/m3. 

Where there is the possibility of a significant uptake via dermal exposure SCOEL recommend 
that  any  OEL  be  accompanied  by  a  'skin  notation'  (in  the  case  of  acrylamide  ACSH  did  not 
comment  on  this  aspect  of  the  SCOEL  Recommendation).    If  adopted  and  accordingly 
transposed by Member States, employers are required under the national transposing legislation 
to take this into account in selecting appropriate risk management measures to protect workers. 

Once the need for managing exposure has been established the only risk management measure 
available in practical terms is to avoid skin contact. Acrylamide has a harmonised classification 
as  a skin irritant  (category 2) and skin  sensitiser (category 1).   These hazards would normally 
result  in  employers  taking  steps  to  avoid  skin  contact  as  a  part  of  routine  OSH  risk  control.  
Adoption of a 'skin notation' should therefore result in no additional cost for employers. 

Table 11. Acrylamide – Comparison of options 

Criteria 

Baseline 

Option 2 
0.1 mg/m3, Sk. 

Option 3 
0.03 mg/m3, Sk. 

Effectiveness 

Efficiency 

Coherence 

Scientific advice 

(SCOEL) 

ACSH 

0 

0 

0 

≈ 

≈ 

+ 

≈ 

≈ 

+ 

Genotoxic carcinogen for which the existence of a threshold cannot be 
sufficiently supported. A reasonable quantitative cancer risk assessment for 
humans is not feasible. 

Any regulation that may be established for acrylamide should also be 
protective against the development of neurotoxicity.  While it is difficult to 
establish a dose-response for neurotoxicity in occupational studies a 'no 
observed affect level' for neurotoxicity resulting from airborne exposure at 
about 0.1 mg/m3 or 0.035 ppm (8-hour TWA) can be inferred. 

Dermal absorption is important in relation to workers under practical working 
conditions, and a ‘skin’ notation is therefore warranted. 
A range from 0,07 to and including 0,1 mg/m3, with a review period of 3 
years. 

The opinion of the social partners and Member States in the ACSH supports option 2, and the 
CMD  further  establishes  an  expectation  that  OELs  be  set  where  it  is  possible  to  do  so. 
Introducing  an  OEL  would  also  be  effective  in  introducing  a  greater  clarity  for  economic 
operators across the EU. 

Impact on Member States and proportionality 

In the case of acrylamide 13 Member States have so far opted either to not to set a limit or to set 
one which is less protective of worker health than the value recommended by ACSH. Figure 10 
in Annex 9 illustrates the ranges of existing national OELs compared to Option 2. The following 
Figure 11 shows distribution of exposed workers across the Member States. 

45 

 
 
The three Member States where the production and/or use of this chemical agent is concentrated 
and  the  numbers  of  exposed  workers  are  the  highest  (DE,  UK  or  FR)  have  no  OEL  or  OELs 
above the proposed limit value of 0.1 mg/m3.  Introducing an OEL would bring a greater clarity 
for economic operators across the EU and 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. 
Introduction  of  an  OEL  of  0.1  mg/m3  would  require  changes  for  a  substantial  number  of 
Member States. It is estimated that approximately 64% of exposed workers are located in those 
13  Member  States.  Even  if  current  exposure  levels  in  the  EU  are  estimated  to  be  below  0.03 
mg/m3, a minimum basis of protection against the risks arising from workers' exposure to these 
carcinogens cannot be ensured for all EU workers under the baseline.  It follows that an action 
taken at the European Union level could be justified. 

5.5  Hardwood dust 

Hardwood  dust  is  listed  in  the  CMD  but  not  classified  according  to  the  EU  CLP  regulation 
(because  it  is  a  PGS);  however  it  is  classified  as  a  Group  1  carcinogen  ("carcinogenic  to 
humans")  by  the  International  Agency  for  research  on  cancer.  Hardwood  dust  may  cause 
sinonasal  and  nasopharyngeal  cancers.  In  addition,  hardwood  dust  may  cause  non-malignant 
respiratory health problems, including occupational asthma. 

Exposure  to  hardwood  dust  occurs  mainly  in  the  wood  working  industry,  furniture 
manufacturing and construction sectors. Over three million EU workers are potentially exposed 
in over 340 000 companies, mostly SMEs, with a production value of around €230 bln/year. 

The  estimates  of  the  prevalence  and  level  of  exposure  to  hardwood  dust  were  based  on  the 
results  of  the  2001-2006  WOODEX  project  and  on  the  timber  statistics  UNECE.  The 
WOODEX  project  aimed  at  estimating  occupational  exposure  to  inhalable  wood  dust  by 
country, industry, level of exposure and type of wood dust in 25 Member States. National labour 
force  statistics,  a  country  questionnaire  (in  15  Member  States,  EU-15),  a  company  survey  (in 
Finland, France, Germany and Spain), exposure measurements (from Denmark, Finland, France, 
Germany,  the  Netherlands  and  the  United  Kingdom),  and  expert  judgments  were  used  to 
generate  preliminary  estimates  of  exposure  to  different  types  of  wood  dust.  These  estimates 
were reviewed and finalised by national experts from 15 Member States. 

The  study  showed  that  construction  employed  33%  of  exposed  workers,  mostly  construction 
carpenters. 20% of exposed workers worked in the furniture industry, 9% in the manufacture of 
builders’  carpentry,  5%  in  sawmilling,  4%  in  forestry.  In  addition,  20%  were  employed  in 
miscellaneous industries employing carpenters, joiners, and other woodworkers. The numbers of 
exposed workers varied by country ranging from <3,000 in Luxembourg and Malta to 700,000 
in Germany. According to the IOM report, the countries with the highest numbers of exposed 
workers  are  Germany  (19.75%  of  all  EU  workers),  Spain  (12.18%),  the  UK  (19.91%),  Italy 
(9.88%) and Poland (9.29%). 

The WOODEX study concluded that the high  wood dust concentrations were measured in the 
furniture industry, in the manufacture of other wooden products, and especially in construction. 
The  mean  wood  dust  concentrations  were  in  fact  the  highest  in  construction.  Regarding  the 
manufacture  of  wood  products  industry,  the  IOM  report  estimates  that  more  than  88%  of 
enterprises  have  between  1  and  9  employees,  while  only  1.5%  have  between  50  and  250 
employees.  The  furniture  manufacturing  sector  is  similarly  mostly  composed  of  very  small 
enterprises  (86%  with  1  to  9  employees)  and  few  large  companies  (2.3%  with  50  to  250 
employees). 

Table 12. Hardwood dust – Types of impacts 

46 

 
 
Impact  Option 1 

Option 2:   
OEL of 3 mg/m3 

Option 3:   
OEL of 1 mg/m3 

Baseline:  OEL  at  5 
mg/m3   

Exposures will continue 
falling by 8% per year. 
Some costs to put into 
place ventilation 
measures expected for 
firms.  

It is considered that EU 
industry is already compliant 
with an exposure limit of 3 
mg/m3. According to the IOM 
Study no additional 
significant costs for firms vs. 
the baseline are expected 
since the average exposure 
across sectors is lower than 
this limit and no change in 
the manufacturing processes 
are foreseen because of a 
lower OEL.  

The health costs 
associated with no action 
up to 2069 are estimated 
to between €3bln and 
16bln, which fall mainly 
on DE, FR, IT, SP and 
UK. 

Total attributable deaths 
for 2010-2069: 5000. 

Total attributable 
deaths/YLL/DALYs for 
2010-2069: data not 
conclusive84 

Net health benefits in 
addition to those under the 
baseline are estimated to 
range between €12mln and 
54mln. 

No significant change to 
current employment and 
working conditions is 
foreseen. 

There are no foreseen 
changes in the end products. 

none 

none 

none 

Additional costs for firms are 
expected compared to the 
baseline, as the OEL will require 
changes in manufacturing 
processes and installation of 
compliant ventilation systems. 
Depending on the anticipation of 
additional investments following 
the baseline investments (10 or 
20 years), those additional 
compliance costs could be 
ranging from €13 bln to 52 bln. 

Such costs risk 
disproportionately affecting 
SMEs, possibly forcing some of 
them out of business or forcing 
firms to shift to other materials to 
avoid compliance costs.  

Total attributable 
deaths/YLL/DALYs for 2010-
2069: data not conclusive  

Net health benefits in addition to 
those under the baseline are 
estimated to range between €66-
325mln. 

New ventilation system would 
require training and maintenance 
efforts, with a small impact as 
85% of firms are estimated to 
already have ventilation in place. 
New ventilation could positively 
improve working conditions. 

There are no foreseen changes in 
the end products.  

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Assumptions concerning declining exposure trends in the IOM study were based results of two 
studies – one from UK, another from the US, both showing steady decrease of exposures over 
approximately 20 years' period. It should be noted however, that other studies do not support the 
resulting  estimate  of  current  compliance  with  an  exposure  level  of  3  mg/m3.  The  WOODEX 
project  provides  data  on  numbers  of  exposed  workers  in  the  EU  as  well  as  on  levels  of 

84  Analysis of the data on deaths and cancer cases from the IOM study showed some inconsistencies, which led to 

the decision to limit the impact analysis to monetised health benefits. 

47 

 
 
 
 
 
 
                                                 
exposure85.  The  WOODEX  data  on  levels  of  exposure  for  2000-2003,  shows  that  25%  of  all 
affected workers are exposed to a level of 2-5 mg/m3 (897 000 workers) and as much as 16% are 
even  exposed  to  levels  higher  than  the  legally  binding  5  mg/m3  (563  000  workers).  In 
construction, which has the highest number of exposed workers (1,190,000), the proportion of 
those exposed to levels higher than 5 mg/m3 reaches 21% or 254 000 workers. 

Option 3 would be the most effective option in reducing occupational exposure to carcinogens. 
It also leads to the highest reduction of estimated health costs. However, it does so at the cost of 
imposing a disproportionate burden on firms and in particular SMEs. It may force SMEs to use 
other type of material or to close down business. On the other hand, option 2 should lead as well 
to a substantial reduction in the health costs, while the negative impact on firms remains very 
low or non-existent. Thus, option 2 is the best scoring option in terms of efficiency. 

The  impact  on  mobile  machinery  might  be  higher  than  on  stationary  machinery  as  it  is 
considered, based  on  the  results  of  a  report  by  the  French authority  quoted  in  the  IOM  study, 
that more companies have already put in place ventilation systems for stationary machinery than 
they have for mobile  machinery. Moreover, concentration exposures vary according to sectors 
and  occupation.  It  is  estimated  that  the  highest  concentrations  (2-3  mg/m3)  are  in  the 
construction  sectors,  while  for  the  other  sectors  concentrations  are  estimated  to  be  generally 
below 1 mg/m3 for those working far from machinery in control rooms or maintenance tasks. 

Exposure  concentrations  for  installers  and  carpenters  across  all  industries  were  generally 
estimated to be between 2-3 mg/m3. Therefore it is assumed that there will not be any significant 
cost to most enterprises to meet Option 2. However, data is missing to assess the impact of the 
OEL  on  non-substitutable  hand-held  machines  and  whether  there  are  alternative  solutions  to 
ensure  that  exposure  levels  will  be  properly  implemented.  Employers  emphasised  that  some 
hand-held  machinery  does  not  allow  going  below  5  mg/m3.  On  the  other  hand  the  workers 
favoured a 2 mg/m3 limit in view of current limit values of 2 mg/m³ or below in the majority of 
Member States. For some MS, 3 mg/m3 is at the limit of feasibility particularly for SMEs while 
other MS favour a 1 mg/m3 limit to further reduce occupational cancer cases. 

Hardwood  exposure  is  also  associated  with  increased  symptoms  of  the  upper  respiratory  tract 
and  to  allergic  (asthma)  and  non-allergic  effects  in  the  lower  respiratory  tract.  As  explained 
above, the direct and indirect costs of illnesses other than cancer were not taken into account in 
the IOM evaluation of the health costs and benefits, leading to a clear under-estimation of the 
health  costs  benefits  of  introducing  a  lower  OEL.  A  2014  British  study86  showed  that 
occupational asthma had a poor prognosis; once a worker develops occupational asthma after a 
latency period the chances of recovery are small. The average direct costs per annum per case 
were  found  to  range  from  £530  to  £715  (670  to  900€),  whereas  the  indirect  costs  range  from 
£1525 to £1685 (1930 to 2140 €). 

Table 13. Hardwood dust – Comparison of options 

Criteria 

Effectiveness 

Efficiency 

Coherence 

Option 1: 
Baseline 
OEL at 5 mg/m3 

Option 2: 
OEL at 3 mg/m3 

Option 3: 
OEL at 1 mg/m3 

0 

0 

0 

+ 

++ 

+ 

++ 

-- 

+ 

85  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 
86  Montano  D.  Chemical  and  biological  work-related  risks  across  occupations  in  Europe:  a  review.  Journal  of 

Occupational Medicine and Toxicology (London, England). 2014;9:28. doi:10.1186/1745-6673-9-28. 

48 

 
                                                 
Scientific advice 
(SCOEL) 

ACSH 

1 mg/m3 (inhalable dust) is probably below the levels to which the cases of 
sino-nasal cancers had been exposed. 
3 mg/m3, measured as inhalable dust, with a review period of between 3-5 
years is proposed. 

The preferred option is 2 (3 mg/m3) because it is the most cost-effective and at the same time is 
the  level  which  came  out  of  the  discussions  between  employers,  employees  and  MS 
representatives at ACSH discussions. 

Impact on Member States and proportionality 

In  the  case of  hardwood  dust  18 Member  States  have  so  far  opted  to  set  a  limit  which  is  less 
protective  of  worker  health  than  the  value  recommended  by  ACSH.  Figure  12  in  Annex  9 
illustrates the ranges of existing national OELs compared to Option 2. The following Figure 13 
shows distribution of exposed workers across the Member States. 

Among the six Member States with the highest numbers of exposed workers, three have an OEL 
which is less protective than the value proposed by the ACSH (ES, UK, IT) and thus there is a 
case of competitive advantage compared to Member States which have adopted more stringent 
measures. On the other hand, the fact that an OEL at 3 mg/m3 or below is already in place in the 
other three Member States with high numbers of exposed workers (DE, PL and FR) as well as in 
six  other  Member  States  (AT,  BE,  CZ,  DK  EE,  NL,  SE)  indicates  that  solutions  exist  to 
practically  implement  the  OEL.  An  even  lower  OEL  exists  for  example  in  Switzerland  (2 
mg/m3) as well as in Canada and Australia (1 mg/m3). 

It should also be noted that as more than 75% of workers exposed to wood dust are exposed to 
both hardwood and softwood dusts, the prevention of the risks posed by hardwood dust will also 
include  softwood  dust. So  in  practice,  the  OEL  on  hardwood  dust  would  also  be  beneficial  to 
protection against exposure to softwood dust. 
Introduction of an OEL of 3 mg/m3 would require changes for a substantial number of MS. It is 
estimated that approximately 48% of exposed workers are located in those 18 Member States. 
Even if it is estimated that EU industry is already compliant with an exposure limit of 3 mg/m3, 
which appears to be an optimistic assumption when the WOODEX data is taken into account, an 
action at EU level could provide a minimum basis of protection against the risks arising from 
workers' exposure to these carcinogens for a significant proportion of workers at risk. 

5.6  Chromium (VI) compounds 

Occupational  exposure  to  chromium  (VI)  compounds  –  also  known  as  hexavalent  chromium 
compounds - has been associated with an increased risk of lung cancer and sinonasal cancer. 

Hexavalent chromium compounds are no longer manufactured in Europe and they are imported 
less  than  in  the  past.  The  main  use  of  hexavalent  chromium  is  found  in  wood  preservatives, 
metal coatings, chromium production and catalyst manufacture. In 2006 about 917,000 workers 
in the EU were exposed. Since 2006, hexavalent chromium has been banned for certain uses (for 
instance  in  new  vehicles  or  electronic  equipment);  the  number  of  workers  with  high  level  of 
exposure is likely to have declined further since then. 

The  number  of  workers'  exposed  to  hexavalent  chromium  was  estimated  on  the  basis  of  the 
Finnish,  Spanish  and  Italian  CAREX  estimates.  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  was  found  for  each  industry.  The  average  proportion  of 
exposed  workers  was  applied  to  information  on  the  number  of  employees  in  each  industry 

49 

 
 
 
obtained from Eurostat. To find the number of exposed workers in each industry in each country 
the average proportion of exposed workers in those three countries was used and multiplied by 
the number of workers employed in each industry in each country in 2006. 

There  are  no  current  hexavalent  chromium  exposure  level  data  available.  Exposure  levels 
presented  are  the  result  of  the  analysis  done  on  a  sample  taken  between  1990  and  1999,  with 
geometric  mean  exposure  representative  of  1995.  The  2010  geometric  mean  exposures  was 
extrapolated  from  the  1995  geometric  mean  exposure  based  on  an  estimated  decrease  in 
exposure  of  7%  per  year.  Due  to  the  limited  availability  of  exposure  data  it is  not  possible to 
present a systematic description of differences in exposure across the EU. The assumption used 
to determine exposure of different countries consider the extrapolated 2010 exposures level in 
high exposure industry groups (Table 17) as typical of exposures throughout the EU. 

The exposure data available for high exposure NACE industries  27, 28 and  35 were collected 
from the UK National Exposure Database (NEDB) and data for NACE 24 were compiled for the 
EU Risk Assessment Report for Chromates using data from industry and the HSE NEDB. No 
data were found for NACE 28 but exposures are likely to be very similar to NACE 2887. 

A  subset  of  chromium  (VI)  compounds  (out  of  over  100),  as  shown  in  table  14,  are  listed  in 
Annex  XIV  of  the  REACH  Regulation  and  so  are,  or  will  be,  subject  to  'authorisation'  for 
continued use. 

Table 14. Chromium (VI) compounds currently in REACH Annex XIV 

Substance 

Trichloroethylene 

Chromium trioxide 

CAS No. 

1979-1-6 

1333-82-0 

EC No. 

201-167-4 

215-607-8 

Chromic acid, oligomers of chromic acid and 
dichromic acid, dichromic acid 

7738-94-5; 13530-68-2 

231-801-5; 236-881-5 

Sodium dichromate 

Potassium dichromate 

Ammonium dichromate 

Potassium chromate 

Sodium chromate 

7789-12-0; 10588-01-9 

234-190-3 

7778-50-9 

7789-9-5 

7789-00-6 

7775-11-3 

231-906-6 

232-143-1 

232-140-5 

231-889-5 

Available evidence (e.g. from the CAREX database) indicates that sodium, potassium, calcium 
and ammonium chromates and dichromates have been identified as the most important in terms 
of workers' exposures, a number of which are already regulated under REACH. 

It is not possible based on available data to identify exposed populations or impacts associated 
only  with  chromium  (VI)  compounds  which  are  not  listed  on  REACH  Annex  XIV,  nor  to 
account  for  the  impact  REACH  authorisation  may  have  on  exposures  for  those  important 
compounds to which it will apply. 

The  IOM  study  assessed  impacts  of  introducing  an  OEL  for  all  chromium  (VI)  compounds, 
including those subject to REACH. 

While this analysis is based on best available data, it should be noted that this results in likely 
overestimates  of  both  the  costs  and  benefits  associated  with  setting  an  OEL  under  CMD  for 
chromium (VI) compounds. 

87  Exposures  in  these  NACE  groups  are  similar  because  arise  chiefly  from  welding  and  other  hot  work  with 

stainless steel. 

50 

 
 
                                                 
Table 15. Chromium (VI) compounds – Types of impacts 

Impact  Option 1 

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Baseline - no OEL 

It is assumed that 
exposures will fall by 
7% per year in the 
future. Therefore, there 
are expected to be 
some costs to firms 
where hexavalent 
chromium exposure 
requires firms to put 
into place ventilation 
measures to reduce 
inhalation exposure. 
These would occur 
regardless of further 
intervention over the 
period 2010 – 2069. 

Option 2 
OEL of 0.025 mg/m3 

Option 4 
OEL of 0.05 mg/m3 

It is estimated that 27% of 
enterprises will require some 
form of control measure to meet 
the proposed OEL (estimate for 
all chromium (VI) compounds). 
It is assumed that the majority of 
those will require ventilation 
systems to reduce exposure levels 
to meet the OEL.  

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  €13.4bln-€52.3 bln. 

However, there appears to be a 
significant burden on SMEs.  

The up-front capital cost of a 
ventilation system is estimated to 
be in the region of €42k -252k. 
This is likely to be a significant 
cost which may potentially result 
in those companies stopping their 
use of chromium or forcing the 
closure of some companies, if 
they are dependent upon the use 
of hexavalent chromium and are 
unable to make the necessary 
investment to achieve appropriate 
levels of to protect workers' 
health. 

It is estimated that 16% of 
enterprises will require some 
form of control measure to 
meet the proposed OEL. It is 
assumed that the majority of 
those will require ventilation 
systems to reduce exposure 
levels to meet the OEL.  

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  €3.6bln-€13 
bln. 

However there appears to be 
a significant burden on 
SMEs. The up-front capital 
cost of a ventilation system is 
estimated to be in the region 
of €42k - 252k. This is likely 
to be a significant cost, 
which may potentially result 
in those companies stopping 
their use of chromium or 
forcing the closure of some 
companies, if they are 
dependent upon the use of 
hexavalent chromium. 

51 

 
 
 
1810 cancer cases would be 
avoided compared to the 
baseline. 

1320 cancer cases would be 
avoided compared to the 
baseline. 

No. of avoided deaths from lung 
and sinonasal cancer in 2060: 
1670. 

No. of avoided deaths from 
lung and sinonasal cancer in 
2060: 1240. 

There are expected to be benefits 
from avoided health care and 
reduced cost of illness due to 
reductions in cancer registrations.  

The benefits are most apparent 
from 2040 onwards. Total 
benefits are estimated at 
€591mln-1.7 bln.  

There are expected to be 
benefits from avoided health 
care and reduced cost of 
illness due to reductions in 
cancer registrations.  

The benefits are most 
apparent from 2040 onwards. 
Total benefits are estimated 
at €440mln-1.3bln.  

No different to the baseline. 

Not different to the baseline 

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23,640 work-related 
cancer cases are 
expected to be 
registered in the period 
2010-2069. 

No. of deaths from 
lung and sinonasal 
cancer in: 17,370. 

The health costs over 
the period 2010-69 are 
estimated to be around 
€8.6-27bln. 

As it is assumed that 
exposures fall by 7% 
per year in the future, 
there is expected to be 
a significant reduction 
in health costs going 
forward in the absence 
of further regulatory 
intervention.  

It is considered that the 
controls in place to 
control environmental 
emissions are sufficient 
to control the potential 
risks to the 
environment. 

The  baseline  scenario  for  all  industries  assumes  a  7%  annual  decline  in  exposure  levels  and 
standards  change  in  employed  numbers  up  to  the  2021-30  estimation  interval.  Due  to  cancer 
latency,  cancer  cases  -  derived  as  a  consequence  of  past  exposure  -  will  continue  to  affect 
workers' population until 2030. This situation urges a timely intervention in regulating exposure 
levels  since  the  introduction  of  an  EU-wide  OEL  could  have  a  significant  positive  long-term 
impact  on  workers'  health.  The  number  of  future  cancer  cases  can  be  most  substantially 
decreased through full compliance with an OEL of 0.025 mg/m3. In addition to the importance 
of combating cancer it should be noted that the chemical agents may cause other adverse health 
effects  at  comparable  threshold  levels  including  nasal  irritation,  severe  skin  damage  or  renal 
toxicity. 

Figure 14 in Annex 9 synthetises the changes in the valence state of chromium at all stages of 
industrial  use  from  mining  production,  to  downstream  industry  activity  and  to  end  use. 
Hexavalent  chromium  and  trivalent  chromium  have  been  coloured  coded  to  emphasise  the 
different states of chromium at the different stages of use.88 

In 2005 the main industrial uses of the chromium (VI) compounds are summarised in Table 16. 
In  2007  the  last  EU  producer  of  hexavalent  chromium  compounds,  located  in  the  UK,  closed 
down following declines in the market. 

88  See Figure 14. Overview of Chromium Valence State in Chromium Applications (annex 9). 

52 

 
 
 
 
 
 
 
                                                 
Table 16. Main industrial uses of the chromium (VI) compounds 

Source: HSE (2007) Human Health Risk Reduction Strategy for Chromates in IOM (2011) Hexavalent Chromium, pp. 5 

In  the  EU  certain  industries  have  been  classified  as  high  in  terms  of  workers  exposure  to 
hexavalent chromium. These industries, grouped by NACE code, were identified from CAREX 
data and are summarised in the table below. 

Table 17. Classification of Industries with High Level Exposure 

Industry 

NACE  Historical Exposure 

Classification 

Number of People 
Exposed in 2006 

Manufacture of chemicals and 
chemical products 

Manufacture of basic metals 

Manufacture of fabricated metal 
products, except machinery and 
equipment 

Manufacture of machinery and 
equipment n.e.c. 

Manufacture of other transport 
equipment 

Manufacture of furniture; 
manufacturing n.e.c. 

24 

High 

27 

28  

29 

35 

36 

High 

High 

High 

High 

High 

42452 

29670 

288480 

134067 

41643 

15942 

Compliance cost analysis shows that the majority of firms within affected industries would meet 
the most stringent proposed OEL (0,025 mg/m3) given that the estimated geometric mean (2010) 
is between 0.002-0.005 mg/m3. However, risks for workers' health are still consistently high as 
shown in Table 18. There are substantial percentages of workers within each industry (NACE) 
who  are  exposed  above  OELs  proposed  under  options  2  and  4.  This  situation  calls  for  timely 

53 

 
 
  
 
and  effective  actions  at  the  EU  level  to  ensure  that  workers'  health  and  safety  at  work  is 
safeguarded.  
Exposure  risks  are  particularly  high  in  SMEs.  Small  companies  have  been  found89  to  be  at 
particular risk of lacking adequate control especially in the manufacture of pigments and dyes, 
the formulation of  metal treatment products  electroplating  and wood dyeing. An inspection  of 
29 chrome planting facilities found that those that used hexavalent chromium were considered 
not  to  be  adequately  controlling  the  risks  and  most  were  not  complying  with  the  relevant 
legislation. An EU-wide OEL would then have the positive effect of raising public awareness of 
these  important  occupational  health  hazards  and  contribute  to  better  monitoring  of  exposure 
levels and increased compliance of industries.  

Table 18. Estimated percentages of workers with exposures exceeding the proposed OEL (Option 2) in high 
exposure industries 

Some  firms  within  affected  industries  would  require  further  control  measures  to  meet  the 
proposed  OEL  given  that  estimated  geometric  standard  deviations  range  from  3.8-14.  For 
enterprises  that  would  need  ventilation  systems  to  comply  with  an  OEL  of  0,025  mg/m3  there 
would be a significant up-front capital cost.90 

It is possible that some firms might be able to pass through additional costs in the form of higher 
prices for their final products since the OEL would be applied consistently across the EU. This 
should  create  a  'level  playing  field'  for  firms  across  the  EU  and  reduce  competitiveness 
distortions created by differences on OELs across the EU. 

On  the  macroeconomic  side,  short  term  spending  on  risk  management  measures  may  also  be 
good  for  the  economy  as  equipment  manufacturers  (ventilation  systems),  installers  and  others 
will benefit with money flowing through the economy. With fewer life year lost, there should be 
also a benefit to the economy through avoided loss of output and consumption in the future (post 
2040).  However,  since  compliance  with  an  OEL  would  not  change  the  current  manufacturing 
process there is unlikely to be any significant change to macro-economic impacts. 

It should further be noted that the impact of REACH authorisation on relevant chromium (VI) 
compounds cannot at this stage be reliably assessed, but should be expected to reduce exposures 
and  result  in  reduced  costs  and  benefits  associated  with  setting  an  OEL  for  these  chemical 
agents.  When  applying  for  REACH  authorisations,  enterprises  need  to  also  invest  in  risk 
management  measures  and  demonstrate  that  risks  are  controlled  (either  'adequately'  or  with 
'appropriate  and  effective  risk  management  measures'  according  to  the  case)  –  potentially 
driving investment in additional risk management measures. 

A  targeted  REACH  restriction  (entry  47  of  REACH  Annex  XVII)  applies  to  placing  on  the 
market  or  use  of  (soluble)  chromium  (VI)  compounds  as  a  component  of  cement,  which  is 
prohibited above a certain concentration.  While this restriction is relevant for worker protection, 
it should not be expected to significantly affect the overall exposure patterns and associated cost 
benefit  assessments  made  in  this  report.  In  any  case,  this  restriction  was  established  prior  to 
REACH (in 2005) and hence its effects have been taken into account in the IOM study. 

89  Health and Safety Executive (2007) Human Health Risk Reduction Strategy for Chromates 
90  Based  on  IOM  consultants'  discussion  with  suppliers,  a  ventilation  system  is  estimated  to  be  in  the  region  of 

€42k-252k. 

54 

 
 
 
                                                 
Table 19. Chromium (VI) compounds – Comparison of options 

Criteria 

Effectiveness 

Efficiency 

Coherence 

Scientific advice 

ACSH 

Option 1 

Baseline 

0 

0 

Option 2 
0.025 mg/m3  

Option 4 
0.05 mg/m3 

++ 

- 

+ 

- 

+ 

+ 

0 
An exposure limit of 0,05 mg/m3 may well provide adequate protection for 
workers exposed to poorly soluble hexavalent chromium compounds but 
consideration could be given to setting exposure limits at 0.025 or 0.01 
mg/m3 for other hexavalent chromium compounds. 
OEL of 0.025 mg/m3. 

The preferred option is 2 which is more effective reducing exposure and therefore the number of 
deaths, while slightly more costly than option 4. In addition, it might trigger more investment in 
research  and  innovation  as  well  as  the  adoption  of  products  that  do  not  contain  chromium. 
Option  2  would  then  be  expected  to  increase  the  dissemination  of  improved  technologies  and 
production methods. The potential volume of ventilation systems being required across the EU 
may  also  stimulate  investment  in  R&D  to  produce  more  cost-effective  systems.  Furthermore, 
with  fewer  life  years  lost  and  cancer  registrations,  there  should  be  a  benefit  to  the  economy 
through  avoided  loss  of  output  and  consumption  in  the  future,  for  example  due  to  greater 
productivity as well as greater consumption and greater taxes raised. 

It should be noted that the workers group in the ACSH argued that even a binding limit of 0.025 
mg/m3  would  correspond  to  a  high  cancer  risk.  Employers'  representatives  did  not  make  any 
specific comments in the ACSH opinion but the metal industry expressed their positive view on 
the establishment of an EU-wide binding OEL as a way to demonstrate appropriate control of 
the  exposure  at  the  workplace  in  the  course  of  meetings  between  Commission  services  and 
industry and workers representatives (see point 9.2.6 in Annex 2). 

Impact on Member States and proportionality 

In the case of chromium (VI) compounds 21 Member States have no OEL for this agent or have 
one that is less protective of worker health than the 0.025 mg/m3 value recommended by ACSH. 
This  includes  5  Member  States  where  the  national  OEL  is  provided  as  a  range,  given  that 
different OELs apply for different specific Cr(VI) compounds.  Figure 15 in Annex 9 illustrates 
the ranges of existing national OELs compared to Option 2 the upper limit has been considered 
for those countries providing a range of values). The following Figure 16 shows distribution of 
exposed workers across the Member States. 

Among the six Member States with the highest numbers of exposed, two have no OEL (DE, IT) 
Introduction  of  an  EU  OEL  could  ensure  that  lack  of  a  national  OEL  or  a  less  stringent  OEL 
does not act as an incentive for business in decisions concerning the plant location. On the other 
hand, the fact that an OEL equal or close to the value proposed by the ACSH is already in place 
in one of the Member States with high numbers of exposed workers (FR) as well as in the US  
indicates that solutions exist to practically implement the OEL such that businesses are able to 
make appropriate investment to protect workers and demonstrate compliance. 

It is estimated that approximately 83% of exposed workers are located in Member States with 
no OEL for this agent or one that is less protective of worker health. An action at EU level could 

55 

 
 
 
 
provide a minimum basis of protection against the risks arising from workers' exposure to these 
carcinogens for a significant proportion of workers at risk. 

5.7  Ethylene oxide (EO) 

EO  is  classified  according  to  the  criteria  in  the  CLP  Regulation  as  a  category  1B  human 
carcinogen based on limited human epidemiological evidence and other data that it may cause 
leukaemia. 

It is used in the manufacture of production of consumer goods such as anti-freeze solvents and 
cosmetics. About 3.8 mln tonnes of EO are produced in Europe each year. The majority is used 
in the manufacturing of ethylene oxide derivates such as ethylene glycols, which are used in the 
production of consumer goods. 

It is estimated that approximately 15,600 workers in the EU are potentially exposed and that in 
the period 2000-2010 in the EU there were about 5 deaths or less per year from leukaemia that 
were attributable to exposure to ethylene oxide before the early 1980s, which corresponded to 
about  0.01%  of  all  deaths  from  leukaemia  and  a  loss  of  82  Disability-Adjusted  Life  Years 
(DALYs) each year. 
Global market for EO is expected to continue expanding.91 

Table 20. Ethylene oxide (EO) – Types of impacts 

Impact 

Option 1 

Option 2 

Baseline - no OEL 

OEL of 1 ppm, Sk. 

Economic 

It is assumed that industries affected have 
already incurred costs of installing control 
measures to reduce ethylene oxide 
emissions. 

Hospitals may replace EO sterilisation units 
with non-EO alternatives which are 
associated with fewer health hazards. The 
development of feasible alternatives may 
benefit research and development in 
exposure controls. 

Social (incl. 
health) 

There is not expected to be any noticeable 
social impacts under the baseline scenario. 

Large-scale implementation of control 
measures during the 1980s and 1990s 
means that exposure is already well below 
1ppm. Therefore there is not estimated to be 
a cancer risk from worker exposure 
ethylene oxide under current conditions. 

Controls on EO in the workplace needed to 
meet the possible OEL of 1ppm have largely 
been installed; therefore it is assumed there 
is not expected to be any significant 
additional compliance cost in meeting an 
OEL of 1ppm relative to the baseline 
scenario. 

Hospitals may replace EO sterilisation units 
with non-EO alternatives which are 
associated with fewer health hazards. The 
development of feasible alternatives may 
benefit research development in exposure 
controls. 

There are not expected to be any social 
impacts relative to the baseline scenario 
from introducing an EU-wide OEL. 

The impacts of introducing an EU-wide 
OEL at 1ppm is estimated to have no health 
benefits as exposure is already estimated to 
be controlled to below 1ppm . 

Environmental  None – controls on EO in the workplace 
needed have already been implemented. 

None – controls on EO in the workplace 
that would be needed to meet the possible 
OEL have already been implemented.  

91  See Figure 17 - The Global Ethylene Trade (Annex 9). 

56 

 
 
 
                                                 
No  ethylene  oxide  exposure  data  were  available  from  industry.  The  peer-reviewed  scientific 
literature  for  occupational  exposure  data  for  the  three  main  uses  of  EO  (i.e.  chemical 
manufacturing,  industrial  sterilization,  hospital  sterilization)  shows  a  baseline  scenario  that 
suggest  that  EO  exposures  is  generally  already  below  1  ppm.  As  a  consequence  there  are  not 
health benefit are expected since exposure is already estimated to be controlled to below 1ppm 
under the baseline scenario. 

The  economic  impact  of  the  baseline  scenario  highlights  that  industries  affected  have  already 
incurred  costs  of  installing  control  measures  to  reduce  EO.  On  the  other  hand,  the  economic 
benefits  could  affect  mostly  research  and  development  due  to  the  introduction  of  non-EO 
alternatives in hospitals. 

Other costs and benefits related to 'social', 'macro-economic', and 'environmental' impact of the 
baseline scenario are negligible. 

Administrative  costs  of  setting  the  limit  of  1  ppm  for  employers  (i.e.  minimising  exposure  of 
workers;  redesign  work  processes;  hygiene  measures;  information  of  workers;  training  staff; 
make  information  available;  consultation  with  employees;  etc.)  are  estimated  to  be  low  since 
firms have already been required to carry out these measures following national legislation. 

Where there is the possibility of a significant uptake via dermal exposure SCOEL recommend 
that any OEL be accompanied by a 'skin notation' (in the case of ethylene oxide ACSH endorsed 
this aspect of the SCOEL Recommendation).  If adopted and accordingly transposed by Member 
States, employers are required under the national transposing legislation to take this into account 
in selecting appropriate risk management measures to protect workers. 

Once the need for managing exposure has been established the only risk management measure 
available  in  practical  terms  is  to  avoid  skin  contact.  Ethylene  oxide  has  a  harmonised 
classification  as  a  skin  irritant  (category  2).    This  hazard  would  normally  result  in  employers 
taking  steps  to  avoid  skin  contact  as  a  part  of  routine  OSH  risk  control.    Adoption  of  a  'skin 
notation' should therefore result in no additional cost for employers. 

Table 21. Ethylene oxide (EO) – Comparison of options 

Criteria 

Effectiveness 

Efficiency 

Coherence 

Scientific advice 

ACSH 

Option 1 

Baseline 

0 

0 

0 

Option 2 

1 ppm, Sk. 

≈ 

≈ 

+ 

SCOEL states that at exposures of 1 ppm 'no genotoxic changes could be 
directly established in exposed humans so far.'92    

A skin notation is warranted, as clear signs of systemic toxicity were reported 
after local application of ethylene oxide.   
OEL of 1 ppm (= 1.83 mg/m3). 

The opinion of the social partners and Member States in the ACSH supports  option 2, and the 
CMD further establishes an expectation that OELs be set where it is possible to do so. 

92  Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for  ethylene  oxide, 

SCOEL/SUM/160, June 2012 

57 

 
 
 
 
                                                 
Impact on Member States and proportionality 

In the case of ethylene oxide nine Member States have no OEL for this agent or have one that is 
less  protective  of worker health than the value recommended by ACSH,  so introduction  of an 
OEL of 1 ppm would represent a significant change in this sense. 

The Figure 18 in Annex 9 illustrates the ranges of existing national OELs compared to Option 2. 
The following Figure 19 shows distribution of exposed workers across the Member States. 

The two Member States where the production and/or use of this chemical agent is concentrated 
and the numbers of exposed workers are the highest (DE, UK) have no OEL or OELs above the 
limit proposed by the ACSH.  Introducing an OEL would bring a greater clarity for economic 
operators across the EU and 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. An OEL of 1 ppm is already 
in place e.g. in Australia, Canada, US, Switzerland, New Zealand and Japan. 

It  is  estimated  that  approximately  43%  of  exposed  workers  are  located  in  the  nine  Member 
States with no OEL or an OEL less protective than proposed. Even if current exposure levels in 
the EU are estimated to be below 1 ppm, 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 achieve this objective could be justified. 

5.8  o-Toluidine 

This  chemical agent may cause bladder  cancer. Occupational exposure is  most  likely to  occur 
through inhalation and dermal contact. 

o-Toluidine  is  utilised  in  the  production  of  dyes  and  pigments.  The  industries  in  Europe  that 
report the highest workers' exposure levels are: i) Manufacture of chemicals, chemical products 
and man-made fibres; ii) Manufacture of rubber products. In the chemical industry exposure to 
o-toluidine can  occur  during  its  production  and  during  its use  in  the  production  of  herbicides, 
dyes  and  pigments,  rubber  chemicals,  epoxy  resin  hardeners,  fungicide  intermediates,  and 
pharmaceutical  intermediates.  o-Toluidine  appears  to  have  been  relatively  well  controlled  in 
most chemical manufacturing facilities for the past several decades. 

The available data indicates that the EU o-toluidine production is centred in France, Germany, 
Italy, the Netherlands and the United Kingdom93. The available information suggests that there 
is no o-toluidine production in the rest of Europe. 

In  the  EU  there  are  approximately  5,500  workers  who  are  potentially  exposed  to  o-toluidine. 
The  prevalence  of  exposure  to  o-toluidine  was  estimated  from  the  Finnish  CAREX  estimates. 
The proportion of exposed workers from the Finnish estimate was applied to information on the 
number  of  employees  in  each  industry  obtained  from  the  structural  business  statistics  and  the 
Labour  Force  Survey  available  on  the  Eurostat  database.  The  Finnish  proportion  of  exposed 
workers was multiplied by the number of workers in each industry in each other Member State. 

Since  Finland  does  not  manufacture  o-toluidine,  the  estimate  of  workers'  exposure  in 
manufacturing  countries  (France,  Germany,  Italy,  the  Netherlands  and  the  United  Kingdom) 
might be underestimated. 

It was judged that 98% of workers are exposed to less than 0.1 ppm. In recent years exposure 
levels have been decreasing by about 8.8% per annum. 

93  IARC 2010 

58 

 
 
 
 
                                                 
Table 22. o-Toluidine – Types of impacts 

Impact 

Option 1 

Option 2 

Option 4 

Baseline - no OEL 

OEL of 0.1 ppm 

OEL of 1 ppm 

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There are expected to be costs 
to o-toluidine related firms to 
put into place improved training 
and cleaning measures to reduce 
inhalation and dermal exposure 
that would occur regardless of 
further intervention over the 
period 2010-2070. 

It is estimated that 
approximately two percent 
of exposures are above 0.1 
ppm. Consequently there 
are some minimal costs for 
companies that do not 
currently comply (€0.5-€2K 
per company). 

Minimal – the vast majority of 
investment required to control 
exposure associated with the 
manufacture of o-toluidine has 
already occurred in the last 20 
years.  

The total cost for all 
concerned companies of 
anticipating investment, 
which is assumed to take 
place already under the 
baseline, is in the range of 
€0.2-1.3 mln 

Small cost saving (a few 
€k) from avoided health 
care.  

Benefit €1.3mln to 
€10.1mln. 

Minimal Cost – it is 
expected that the imposition 
of measures would not 
cause significant additional 
environmental impacts. At 
the same time, it is not 
expected that the measures 
for human health would 
lead to any significant 
additional environmental 
benefit above the baseline 

The health costs of cancer 
(bladder) over the period 2010 – 
2070 are estimated to be  
€86mln to €696mln 

It is assumed that exposures 
will fall by 8.8% per year in the 
future. 

Therefore, there is expected to 
be some reduction in health 
costs going forward in the 
absence of further regulatory 
intervention. 

Minimal - Only 2% of workers 
exposed to o-toluidine are 
estimated to be exposed above 
0.1 ppm, and therefore most 
workplaces are unlikely to 
require further changes to their 
existing working practice. The 
risk of more direct or more 
concentrated emissions of o-
toluidine to the environment 
(through ventilation), is 
therefore small.  

No change - There are not 
expected to be any additional 
health costs relative to the 
baseline scenario. 

There are expected to be 
negligible additional health 
benefits relative to the baseline 
scenario, as exposure is already 
expected to be largely / wholly 
below 1 ppm. 

Similar to the baseline as 
controls on o-toluidine in the 
workplace already in place.  

On  the  basis  of  estimates  of  the  number  of  workers  exposed  and  the  Eurostat  data  on  the 
distribution  of  firms  by  size,  broad  estimates  of  the  number  of  enterprises  requiring  further 
action to comply with each proposed EU-wide OEL were produced (Table 23-24). 

Tables 23-24 show that a total of nine firms are estimated to be affected by an EU-wide OEL at 
0.1 ppm while no firms would be affected if an OEL of 1 ppm were to be introduced. It is not 
expected that there would be any significant and additional potential closure of companies as a 
result of introducing an EU-wide OEL of 0.01 ppm because compliance costs are  likely to  be 
minimal. 

59 

 
 
 
 
 
 
 
Table 23. Numbers of Enterprises affected in NACE group 25.1 

Table 24. Numbers of Enterprises affected in NACE division 23 

The industrial sector estimated to benefit most from the introduction of an EU-wide OEL is the 
manufacture  of  chemicals.  The  administrative  costs  for  employers  are  estimated  to  be  low  in 
both  baseline  scenario  and  in  the  intervention  scenario  of  OEL  1  ppm,  since  most  of  the 
investments  needed  to  decrease  the  exposure  have  already  been  made.  Low  to  medium  costs 
would involve firms that do not currently comply with baseline scenario in case an OEL of 0.1 
ppm was going to be implemented. 

Table 25. o-Toluidine – Comparison of options 

Criteria 

Effectiveness 

Efficiency 

Coherence 

Scientific advice 

Option 1 

Baseline 

0 

0 

Option 2 

0. 1 ppm 

+ 

≈ 

Option 4 

1 ppm 

≈ 

+ 

   0 
IOM Study considered potential OELs of 0.1 ppm (0.4 mg/m3) and 1 ppm 
(4.4 mg/m3) as 'typical' values of existing national OELs in the EU. 

+ 

+ 

ACSH 

Proposes an OEL of 0.1 ppm   

60 

 
 
 
 
 
Neither  option  is  predicted  to  give  rise  to  any  important  reduction  in  bladder  cancer  death  or 
registrations over the baseline assumptions, primarily because exposures are already very low. 
However,  the  preferred  option  is  2  as  it  brings  some  health  benefits  while  generating  only 
slightly higher costs than option 4. Industry is almost fully compliant with this OEL already and 
0.1  ppm  has  been  accepted  by  all  parties  in  the  ACSH  discussions.  Switzerland  and  New 
Zealand have set lower OELs for this chemical agent. 

Impact on Member States and proportionality 

In the case of o-Toluidine 25 Member States have no OEL for this agent or have one that is less 
protective of worker health than the value recommended by ACSH. The Figure 20 in Annex 9 
illustrates the ranges of existing national OELs compared to Option 2. The following Figure 21 
shows distribution of exposed workers across the Member States. 

Thus, introduction of an OEL of 0.1 ppm would represent a significant change in this sense. It is 
estimated that approximately 98% of exposed workers are located in those 25 Member States. 
Even if current exposure levels in the EU are estimated to be largely below 0.1 ppm, a minimum 
basis of protection against the risks arising from workers' exposure to these carcinogens cannot 
be ensured for all EU workers under the baseline scenario – it follows that an action taken at the 
European Union level to achieve this objective could be justified. 

5.9  Refractory Ceramic Fibres (RCF) 

Occupational exposure to RCFs is associated with adverse respiratory effects as well as skin and 
eye irritation and may pose a carcinogenic risk based on the results of chronic animal inhalation 
studies.  However,  epidemiologic  studies  have  found  no  association  between  occupational 
exposure to airborne RCFs and an excess rate of pulmonary fibrosis or lung cancer. Based on 
the animal test results, certain RCFs are classified according to the CLP Regulation as Carc. 1B 
(may cause cancer by inhalation). 

RCFs  are  synthetic  vitreous  fibres  or  man-made  mineral  fibres  used  in  industry  for  their 
properties of heat resistance, tensile strength and durability. The total tonnage of RCF used in 
the EU is about 25,000 tonnes per year, 90% of which is used for industrial insulation. Ceramic 
fibres are typically used only in industrial settings, implying no consumer exposure. 

For the estimations,  due to unavailability  of epidemiological data, exposure to  RCFs has  been 
assumed to be no worse than exposure to chrysotile (white) asbestos in terms of cancer risk. 

On the basis on information provided by the European Ceramic Fibre Industry Association, it is 
estimated that about 10,000 workers are exposed to RCF across the EU. Of these, about 730 are 
employed  in  RCF  production  plants  in  Germany,  France  and  the  UK,  and  about  9,270  in  the 
downstream  user  industry  (a  breakdown  by  Member  State  not  available.  Geometric  mean 
exposures in the industry are less than 0.2 fibres/ml and it is estimated that about 7% of workers 
in manufacturing facilities and 12% of workers at downstream user facilities have been exposed 
above 1 fibres/ml. More than half of workers are exposed above 0.1 fibres/ml. A majority of the 
companies in question (downstream use) are SMEs. 

It should be noted that, in December 2011, certain RCFs were identified as 'substances of very 
high  concern'  under  REACH  owing  to  classification  under  CLP  as  a  category  1B  carcinogen.  
This  constitutes  the  initial  step  toward  possible  inclusion into  REACH  Annex  XIV  and  hence 
REACH 
the  European  Chemicals  Agency  further 
recommended  to  the  European  Commission  that  RCF,  among  other  chemical  substances,  be 
included into REACH Annex XIV. 

'authorisation'.  In  February  2014 

61 

 
 
Two possible substitutes for RCF are Alkaline-Earth Silicate Glass Wool (AES), which however 
is an imperfect substitute (having a lower applicable temperature range for thermal insulation), 
and Polycrystalline Wool (PCW), which however is 20 times more expensive than RCF. 

Table 26.  Refractory Ceramic Fibres (RCF) – Types of impacts 

Impact  Option 1:  

Option 2: 

Option 3: 

Option 4: 

Baseline: No OEL 

OEL of 0.3 f/ml 

OEL of 0.1 f/ml 

 OEL of 1 f/ml 

c
i
m
o
n
o
c
E

A 7% annual decline 
in average exposure 
is assumed until 
2030. 

The total cost for of 
anticipating investment, 
which is assumed to 
take place already under 
the baseline, is in the 
range of EUR 1-6 mln. 

 Substitution with 
alternatives would not 
occur. 

No additional 
significant costs for 
firms vs. the 
baseline are 
expected, as 
average exposure is 
already below 1 
fibres/ml. 

To achieve exposure at 
this level would require a 
degree of automation and 
enclosure that is deemed 
not to be feasible for 
certain downstream uses. 
Estimated total additional 
costs is in the range of 
EUR 60-139mln. 

If achieving the OEL is 
technically or 
economically infeasible, 
companies may decide to 
substitute RCF with 
alternatives. In such case, 
the associated total costs 
could be of the order of 
EUR 2.5 bln.  

It is possible that such an 
OEL could lead to firms 
relocating production 
processes outside of the 
EU. 

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

l
a
i
c
o
S

l
a
t
n
e
m
n
o
r
i
v
n
E

Total attributable 
deaths for 2010-
2069: 50. Total 
YLLs: 830. Total 
DALYs: 860.  

The total cancer-
related health costs 
over a 60-year period 
are estimated to be in 
the range of EUR 33-
83mln. 

Total attributable deaths 
for 2010-2069: 0. Total 
YLLs: 790 (40 less than 
the baseline). Total 
DALYs: 800 (50 less 
than the baseline). 

Total attributable deaths 
for 2010-2069: 0. Total 
YLLs: 790 (40 less than 
the baseline). Total 
DALYs: 800 (50 less 
than the baseline). 

Net cancer-related 
health benefits are 
estimated to be in the 
range of EUR 1.1-
3.4mln.  

Net cancer-related health 
benefits are estimated to 
be in the range of EUR 
1.2-3.4mln.  

None. 

None. 

The use of AES and PCW 
as substitutes for RCF as 
a furnace insulation has 
environmental costs 
including worsened 
energy efficiency. 

Total attributable 
deaths for 2010-
2069: 0. Total 
YLLs: 790 (40 less 
than the baseline). 
Total DALYs: 810 
(40 less than the 
baseline).  

Net cancer-related 
health benefits are 
estimated to be in 
the range of EUR 
1.1-3mln. 

None. 

The values of health benefits are relatively low for all the options because of the low level of 
assumed cancer incidence under the baseline and the existing controls in place. 

62 

 
 
 
 
 
 
 
Option 3 would be the most effective option in reducing occupational exposure  to carcinogens 
and  levelling  the  playing  field  across  the  Union.  However,  it  raises  significant  problems  of 
technical feasibility (the OEL may de facto not be achievable in some instances) and imposes 
therefore  excessive  burden  on  firms  even  if  some  of  the  costs  associated  with  substitution  of 
RCF  with  more  expensive  alternatives  (such  as  PCW)  would  be  passed  through  to  consumers 
via higher prices. Option 2 appears to be more efficient. It leads to a similar reduction of Years 
of Life Lost and Disability Adjusted Life Years as Option 3, but at a significantly lower cost.  

Table 27. Refractory Ceramic Fibres (RCF) – Comparison of options 

Criteria 

Option 1 

Option 2:   

Option 3:  

Option 4:   

Effectiveness 

Efficiency 

Coherence 

Scientific 
advice 
(SCOEL) 

ACSH 

Baseline: No 
OEL 

0 

0 

0 

0.3 f/ml 

0.1 f/ml 

1 f/ml 

++ 

- 

+ 

++ 

-- 

+ 

+ 

≈ 

+ 

RCF is considered as a genotoxic carcinogen for which a practical threshold is 
supported. An OEL of 0.3 f/ml is proposed. 

Agrees that an OEL is necessary but could not reach agreement on exact value 
(between 0.3 f/ml and 0.1 f/ml). 

Option 2 because is the most effective and corresponds to the limit recommended by SCOEL. 
Some MS have already imposed nationally a similar OEL, and there are no concerns regarding 
technical  feasibility.  In  addition,  this  is  the  minimum  common  denominator  of  ACSH 
discussions. Employers advise to follow the recommendation of SCOEL. They also stress that 
industries have been working on a 0.5 f/ml exposure limit for many years, and further reductions 
of exposure are technically difficult. Views of Member States range from 0.3 f/ml to 0.1 f/ml. 
The workers argue for an OEL 0.1f/ml on the basis of considerations detailed in the scientific 
explanations  given  for  the  exposure  risk  relationship  on  aluminosilicate  fibres  derived  in 
Germany, according to which aluminosilicate fibres exhibit a carcinogenic potency comparable 
to asbestos. 94 

Impact on Member States and proportionality 

In  the  case  of  RCF,  24  Member  States  have  no  OEL  for  this  agent  or  have  one  that  is  less 
stringent than 0.3 f/ml. Figure 22 in Annex 9  illustrates the ranges of existing national OELs 
compared to Option 2. There is insufficient data to provide a breakdown by Member State. 

RCF is only manufactured in three MS (FR, UK, DE) but exposure from use and disposal (e.g. 
from insulation in furnaces) may be located across Europe. Thus, introduction of an OEL of 0.3 
f/ml would require changes for a substantial number of MS. The analysis shows that a minimum 
basis of protection against the risks arising from workers' exposure to these carcinogens cannot 
be ensured for all EU workers under the baseline scenario – it follows that an action taken at the 
European Union level to achieve this objective could be justified. 

5.10  Respirable Crystalline Silica 

RCS is taken here to mean 'the respirable fraction of crystalline silica dust generated by a work 
process'.  RCS, so-defined, is a process generated substance which is not placed on the market 

94  Begründung zur Exposition-Risiko-Beziehung für Aluminiumsilikat-Fasern, AGS-Geschäftsführung - BAuA 

63 

 
 
 
                                                 
and, as such, is not classified under the CLP Regulation. This is the reason why it is proposed to 
be included in Annex I of the CMD. In addition, a few options for an OEL value to be included 
in the Annex III are considered. 

IARC has  stated its opinion  that 'crystalline silica inhaled in the form of  quartz or cristobalite 
from occupational sources is carcinogenic to humans (Group 1)'.95 

Crystalline  silica  is  abundant  in  rocks,  sands  and  soils.  Exposure  to  RCS  therefore  occurs  in 
many  industries.  Common  exposure  scenarios  include  earth  moving  (eg.  mining,  quarrying, 
tunnelling),  crushing  or  grinding  of  silica-containing  material  such  as  concrete,  aggregate  or 
mortar, the manufacture of glass and other non-metallic mineral products and the use of sand as 
moulding media in foundries. 

It is estimated that 5,300,000 EU workers are potentially exposed, more than 70% of them in the 
construction  sector.  Beside  construction,  the  following  industries  are  estimated  to  have  the 
highest exposure levels compared to the other industry sectors as well as the highest numbers of 
exposed  workers:  manufacture  of  other  non-metallic  mineral  products,  other  mining  and 
quarrying,  manufacture  of  basic  metals,  manufacture  of  fabricated  metal  products,  electricity, 
gas, steam and hot water supply. 

Table 28. Respirable Crystalline Silica – Types of impacts 

Impact  Option 1: 

Option 2:   

Option 3: 

Option 4:   

c
i
m
o
n
o
c
E

Baseline - not 
under Annex I, no 
OEL 

Inclusion in Annex 
I and OEL at 0,1 
mg/m3 in Annex III 

It is assumed that 
exposures fall by 
7% per year  

Therefore firms 
will already be 
incurring costs for 
exposure control 
measures even 
without EU 
intervention.  

There are not 
expected to be any 
noticeable 
macroeconomic 
impacts. 

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 
around €3.5 bln. 

The greatest costs are 
predicted to fall on 
the construction 
sector given the 
number of 
enterprises thought 
to be affected 
(around 370,000).An 
impact on SMEs is 

Inclusion in 
Annex I and OEL 
at 0,05 mg/m3 in 
Annex III 

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 
around €15.7 bln. 

The greatest costs 
are predicted to 
fall on the 
construction sector 
given the number 
of enterprises 
thought to be 
affected (around 
485,000).A 

Inclusion in Annex I 
and OEL at 0,2 mg/m3 
in Annex III 

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 
around €207 mln. 

The greatest costs are 
predicted to fall on the 
construction sector given 
the number of 
enterprises thought to be 
affected (around 
250,000).The impact on 
companies and 
particularly on SMEs is 
weaker as costs of 
compliance would be 

95  http://monographs.iarc.fr/ENG/Monographs/vol68/mono68-6.pdf    In  making  its  overall  evaluation  the  IARC 
Working  Group  noted  that carcinogenicity in  humans  was  not detected in  all industrial circumstances  studied, 
and  that  carcinogenicity  may  be  dependent  on  inherent  characteristics  of  the  crystalline  silica,  or  on  external 
factors  affecting  its  biological  activity  or  distribution  of  its  polymorphs.    It  should  be  noted  that  the  common 
silica  'polymorphs'  (i.e.  different  forms  of  crystallised  silica)  quartz,  cristobalite  and  tridymite  have  all  been 
classified according to the CLP Regulation by suppliers.  Some suppliers have classified quartz and crystobalite 
as carcinogenic category 1.  Tridymite has not been so classified.  No harmonised (mandatory) classification has 
been proposed. 

64 

 
 
 
                                                 
Impact  Option 1: 

Option 2:   

Option 3: 

Option 4:   

Baseline - not 
under Annex I, no 
OEL 

Inclusion in Annex 
I and OEL at 0,1 
mg/m3 in Annex III 

foreseen, with a risk 
of closures or 
relocations outside 
the EU. This is due 
to high costs linked 
with the installation 
of exposure control 
measures.  

There will be some 
short terms benefits 
(for ventilation and 
respiratory protective 
equipment 
manufacturers). 

l
a
i
c
o
S

Total attributable 
deaths for 2010-
2069: 440 000 
deaths. 

There is also 
expected to be 
some reduction in 
health costs. The 
health costs of 
cancer (lung) over 
the period 2010- 70 
are estimated to be 
€192-493bln.There 
is estimated to be a 
greater number of 
firms installing and 
using closed 
systems and using 
RPE, PPE and wet 
cleaning rather than 
dry cleaning. 

These should not 
affect the skills 
required by 

Total attributable 
deaths for 2010-
2069: 341.330, i.e. 
98.670 less than 
under baseline. 

Net health benefits 
are estimated to 
range between €34 
and 89 bln.  

The introduction of 
the OEL may affect 
job patterns and 
would necessitate 
new health and 
safety training. The 
potential closing 
down or relocation of 
companies would 
have a negative 
impact on 
employment; 
however, the 
reduction of 
exposure would 

65 

Inclusion in Annex I 
and OEL at 0,2 mg/m3 
in Annex III 

lower. 

Total attributable deaths 
for 2010-2069: 357.620, 
i.e. 82.380 less than 
under baseline. 

Net health benefits are 
estimated to range 
between €27.7 and 73.7 
bln.  

As the risks of closure 
are expected to be 
smaller – and even 
minimal if financial 
assistance schemes are 
made available for 
SMEs – there is not 
significant impact on 
employment.  

Inclusion in 
Annex I and OEL 
at 0,05 mg/m3 in 
Annex III 

significant impact 
on SMEs is 
foreseen, with a 
high risk of 
closures or 
relocations outside 
the EU. This is due 
to high costs 
linked with the 
installation of 
exposure control 
measures.  

There might be 
some short terms 
benefits 
(ventilation and 
respiratory 
protective 
equipment 
manufacturers). 
However 
compliance costs 
might be passed on 
to consumers 
(higher prices). 

Total attributable 
deaths for 2010-
2069: 332.650, i.e. 
107.350 less than 
under baseline. 

Net health benefits 
are estimated to 
range between 
€36.5 and 97.1 bln.  

The introduction of 
the OEL may 
affect job patterns 
and would 
necessitate new 
health and safety 
training. The 
potential closing 
down or relocation 
of companies 
would have a 
negative impact on 
employment; 
however, the 
reduction of 

 
 
Impact  Option 1: 

Option 2:   

Option 3: 

Option 4:   

Baseline - not 
under Annex I, no 
OEL 

Inclusion in Annex 
I and OEL at 0,1 
mg/m3 in Annex III 

improve working 
conditions. 

Inclusion in Annex I 
and OEL at 0,2 mg/m3 
in Annex III 

Inclusion in 
Annex I and OEL 
at 0,05 mg/m3 in 
Annex III 

exposure would 
improve working 
conditions. The 
OEL could require 
workers to be 
constantly wearing 
respiratory 
protective 
equipment as 
levels of exposure 
will be close to the 
natural background 
level of RCS in air. 

workers and 
training costs are 
expected to be 
small. 

Since the control 
measures such as 
closed system 
reduce risks of 
human exposure in 
a way that should 
not inhibit 
production, there 
should also be 
improvements in 
working conditions. 

The use of wet 
cleaning and RPE 
should also reduce 
risks of human 
exposure, although 
their use may 
potentially slow 
down operations or 
be perceived to do 
so. 

Very little 
information is 
available regarding 
the ecotoxicitiy of 
RCS. No 
significant 
environmental 
effects are expected 
due to the chemical 
inertness and slow 
solubility of the 
chemical agent. 
Crystalline silica is 
resistant to 
decomposition by 
weathering, 
biological activity 
and further 
oxidation. 

l
a
t
n
e
m
n
o
r
i
v
n
E

The same as in 
Option 2. 

The same as in Option 2. 

No major 
environmental 
impact is foreseen. 
There might some 
impact due to 
increased emission 
of RCS to the 
environment, and 
additional demand 
for electricity due to 
ventilation systems. 

As  in  the  case  of  all  other  considered  chemical  agents,  the  exposure  trends  for  RCS  used  to 
establish  the  baseline  are  quoted  from  the  IOM  study.  The  validity  of  these  assumptions  is 
discussed in the introduction to section 5. Specifically for silica the correctness of the assumed 

66 

 
 
 
7% decline can be further questioned based on the fact that among the three studies that IOM 
used to build this assumption, two are only looking at quarries. The only one that analyses all 
industries  comes  from  the  US.  Lack  of  data  for  the  two  principal  exposure  sectors 
("construction" and the "electricity, gas, steam and hot water supply") weakens the assumption 
of exposure decline. 

A different exposure trend can be derived for example from a Finnish study (Kauppinen et al., 
2013)96, which looked at data from FINJEM database, starting in 1950 and projected trends till 
2020.  This  study  found  that  an  overall  exposure  decline  was  1%  rather  than  8%.  The  data 
presented  in  this  study  shows  also  that  exposures  were  declining  significantly  faster  between 
1950 and 1990, compared to more recent years.97 

Even with the IOM studies estimates, a high proportion of workers are considered to still be at 
risk  of  being  exposed  above  the  considered  OELs  (14%  above  0.2  mg/m3,  26%  above  0.1 
mg/m3, 41% above 0.05 mg/m3), and the estimated mean exposure is 0.07 mg/m3. 

The prevalence of exposure to RCS in the IOM report was estimated from a Finnish, a Spanish 
and an Italian study. The proportion of exposed workers in each industry was taken from each of 
these three studies and the average proportion exposed across all three countries was found for 
each  industry.  The  average  proportion  of  exposed  workers  was  applied  to  information  on  the 
number  of  employees  in  each  industry  obtained  from  the  structural  business  statistics  and  the 
Labour  Force  Survey  available  on  the  Eurostat  database.  The  average  proportion  of  exposed 
workers was multiplied by the number of workers employed in each industry in each country in 
2006 to estimate the number of exposed workers in each industry and country. 

However  there  is  a  limited  availability  of  exposure  data,  and  it  is  not  possible  to  determine 
exposure  differences  across  the  EU.  Moreover,  exposure  levels  and  therefore  cancer  risk  vary 
greatly according to the sectors. 

According  to  the  IOM  report,  the  countries  with  the  highest  numbers  of  exposed  workers  are 
Spain (26.8% of all EU workers), Germany (11.8%), France (11%) and the UK (9.4%).  

In  all  industries  with  high  prevalence  of  RCS  exposure,  the  majority  (between  58  and  94% 
depending on the industry) of companies are very small, with 1 to 9 employees. The industrial 
minerals  industry  alone  consists  mainly  of  SMEs  with  some  large  multinational  companies. 
Members of the Industrial Minerals Association operate over 810 sites throughout Europe. 

The IOM report recognises that the number of workers and enterprises affected by the proposed 
reduction in the OEL are likely to be an overestimate since the NACE codes include activities in 
which workers may not necessarily be exposed to RCS. 

In  all  the  considered  options,  introducing  an  OEL  for  RCS  will  contribute  to  reducing 
attributable deaths compared to no action, and the benefits of introducing an OEL may outweigh 
compliance  costs.  Moreover,  any  reduction  of  exposure  will  also  lower  the  risk  of  silicosis. 
Indeed  exposure  to  respirable  crystalline  silica  in  workplace  air  is  associated  with  the 
development of silicosis, an irreversible scarring disease of the lung. Silicosis also appears to be 
a significant risk factor for the development of lung cancer. As the health costs of silicosis were 
not  taken  into  account  in  the  IOM  report,  the  total  health  benefits  of  introducing  an  OEL  are 
clearly higher than was has been indicated for the purposes of this proposal. 

While the compliance costs are relatively high for all three options, they should be compared to 
the  total  value  of  goods  and  services  in  the  affected  sectors,  which  was  €5  trillion  in  2006. 

96  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 
97  See  Figure  23  -  Occupational  inhalation  exposure  to  crystalline  silica  (quartz  dust)  in  Finland  in  1950,  1970, 

1990 and 2008 and predicted for 2020, as measured by four different metrics of exposure (Annex 9). 

67 

 
                                                 
Moreover, the bulk of compliance costs will be already incurred under the baseline scenario (i.e. 
in  the  absence  of  EU  action).  Imposing  an  EU  OEL  would  however  oblige  businesses  to 
anticipate the corresponding investments. 

It should also be added that the options have variable impacts on different sectors. For example, 
for quarrying, costs are significantly lower under option 4 compared to both 2 and 3. For some 
other sectors, such as foundry, brick manufacture or silica sand production options 2 and 4 result 
in  the  same  costs.  As  for  the  construction  sector,  which  represents  a  majority  of  the  affected 
firms, average cost per enterprise is the same under all three options. 

Option 3 would be the most effective in reducing occupational exposure to carcinogens but will 
have a negative impact on some sectors of the industry98, and in particular on SMEs. Option 2 
has  similar  characteristics,  however  its  impact  should  be  lower  on  the  industry.99  At  least  17 
countries are reported to have already introduced an OEL of 0,1 mg/m3 or below.100 A majority 
of EU countries are therefore already compliant with Option 2, which indicates that the impact 
of  introducing  Option  2  would  be  lower  than  Option  3.  Option  4  would  imply  the  lowest 
compliance costs and the least negative impact on SMEs, however it would be less effective in 
reducing cancer. Moreover, the OEL of 0,2 mg/m3 would be higher than the majority of national 
OELs already in place. No significant environmental impact is foreseen in none of the options. 

Some stakeholders argue that the Carcinogens Directive is not the appropriate legal framework 
to  introduce  OELs  for  RCS  –  instead,  they  argue  for  introduction  of  an  EU  OEL  via  the 
Chemical Agents Directive as the most efficient risk management tool. 

A mechanism exists to establish EU OELs via the Chemical Agents Directive  – these may be 
either  'binding'  (mandatory  maximum)  or  'indicative'  (indicated  maximum)  in  nature,  with 
Member States committed, as a minimum requirement, to in any case ensure that national OELs 
are  established  for  the  chemical  agents  in  question,  taking  into  account  the  values  set  at  EU 
level. 

However,  RCS  is  a  long-  and  widely-recognised  occupational  carcinogen  –  including  long-
standing  classification  by  IARC.  A  clear  threshold  for  silicosis  development  cannot  be 
identified, and there is sufficient information to conclude that preventing the onset of silicosis 
will  also  reduce  the  cancer  risk.101    It  is  therefore  most  appropriate  to  establish  an  EU  OEL 
under CMD for this chemical agent where it is either generated as a result of a work process or 
otherwise classified as a category 1 carcinogen according to the CLP criteria. 

Stakeholders also put forward existing guidelines and good practices. Most notably, as reported 
above,  NEPSi  requires  signatories  to  follow  good  practices  and  monitoring  protocol,  and  to 
provide quantitative data. 

98  Compared  to  option  4,  option  3  creates  higher  costs  per  enterprise  in  the  following  sectors:  quarry,  foundry, 

ceramics, brick manufacture, silica sand production, scouring powders, stonemasonry.  

99  Compared  to  option  4,  option  2  creates  higher  costs  per  enterprise  in  only  three  sectors:  quarry,  ceramics, 

stonemasonry. 

100 BE, BG, CZ, DK, EE, ES, FI, FR, HR, IE, LT, MT, NL, RO, SE, SK, UK 
101 Further  information  on  the  carcinogenity  of  silica  can  be  found  in  Annex  12.  The  current  SCOEL 
recommendation  refers  IARC  Monograph  68.  More  recent  information  on  the  carcinogenicity  of  RCS  in  the 
IARC monograph volume 100C on arsenic, metals, fibres and dusts, which is likely to be taken into account in a 
future  revised  SCOEL  recommendation,  further  confirms  the  carcinogenity  of  RCS  based  on  newer  scientific 
evidence. 

68 

 
 
 
 
                                                 
Table 29. Respirable Crystalline Silica (RCS) – Comparison of options 

Criteria 

Option 1: 

Option 2:   

Option 3: 

Option 4:   

Baseline - not 
under Annex I, 
no OEL 

Inclusion in 
Annex I and 
OEL at 0,1 
mg/m3 

  Inclusion in 
Annex I and 
OEL at 0,05 
mg/m3 

Inclusion in 
Annex I and OEL 
at 0,2 mg/m3 

0 

0 

0 

+ 

+ 

++ 

++ 

- 

+ 

- 

++ 

- 

An OEL should lie below 0.05 mg/m3 of respirable silica dust 

ACSH: A binding OEL at 0.1 mg/m3, measured as respirable dust, is 
justified. The value should be reviewed within 3-5 years.  

Effectiveness 

Efficiency 

Coherence 

Scientific advice 
(SCOEL) 

ACSH 

Option 2 (0,1 mg/m3) is a feasible option for EU industries, while still guaranteeing a substantial 
reduction of estimated attributable deaths due to lung cancer. Introducing an OEL of 0.05 mg/m3 
would  increase  the  estimated  health  benefits  by  around  10%,  but  would  also  increase  the 
estimated compliance costs by close to 80%. It is therefore considered that the cost/benefit ratio 
of introducing an OEL 0,1 mg/m3 is better than introducing an OEL of 0.05 mg/m3. 

It  is  also  the  level  agreed  by  the  ACSH  even  if  there  were  some  questions  on  the  part  of 
employers and some MS whether it would not be more appropriate to legislate under the CAD. 
Workers stated that further exposure reduction below the proposed binding OEL of 0.1 mg/m³ is 
paramount to reduce the risks of lung cancer, and silicosis. 

According to the IOM report there is a risk that production would be affected as a result of the 
need to comply with more stringent OELs and with high compliance costs. Indeed, the majority 
of the companies that would be affected by the imposition of an OEL are SMEs and the costs 
may  be  very  expensive  for  a  large  proportion  of  the  affected  sectors.  If  the  costs  cannot  be 
passed through to consumer prices and/or some companies will not be able to get access to loans 
to  pay  for  the  necessary  investment,  there  is  a  possibility  of  some  company  closures  and,  for 
industries  for  which  it  is  possible,  some  relocation  of  activities  in  non-EU  countries.  Such 
impacts may be differentiated at the sector and sub-sector level, by geographical location, and/or 
at operator level.  

Among the six Member States with the highest numbers of exposed workers (see Figure 25 in 
Annex 9), two have no OEL (DE, IT) and one has an OEL significantly less protective than 0.1 
mg/m3  (PL)  thus  there  is  a  case  of  competitive  advantage  compared  to  Member  States  which 
have adopted more stringent measures. On the other hand, the fact that an OEL equal or below 
the value proposed by the ACSH is already in place in the other three Member States with high 
numbers  of  exposed  workers  (ES,  FR,  UK)  and  in  14  other  Member  States  indicates  that 
solutions exist to practically implement the OEL. 
It should also be noted that an OEL at 0,1 mg/m3 is comparable or higher to the levels applied in 
most  non-EU  countries  (except  notably  China).  For  the  USA,  a  new  value  of  0,05  mg/m3  is 
being  proposed  for  RCS102.  The  proposed  revision  of  the  existing  value  is  based  on  evidence 
that  indicates  employees  exposed  to  RCS  well  below  the  current  value  of  0,1  mg/m3  are  at 
increased risk of lung cancer mortality and silicosis mortality and morbidity. At the same time, 
it  is  assumed  that  an  OEL  of  0.05  mg/m3  would  be  technologically  feasible  for  most  affected 

102 Federal Register / Vol. 78, No. 177 / Thursday, September 12, 2013 / Proposed Rules 

69 

 
 
                                                 
industries,  except  two  out  of  12  construction  activities,  and  would  not  have  any  major  micro- 
and macro-economic impact. 

Finally, the reluctance on the part of employers to accept that RCS is regulated under the CMD 
appears  to  be  related  to  concern  regarding  the  stricter  standard  for  substitution  and  exposure 
control  (process  enclosure)  resulting  from  application  of  the  CMD  over  CAD.    There  is  also 
some concern regarding stigmatisation of silica as a carcinogen and associated negative impacts 
on  industry,  for  instance  in  case  of  'social  license'103  to  operate  mines  and  quarries.    It should 
however  be  noted  that  some  forms  of  RCS  have  been  classified  as  carcinogenic  by  the  IARC 
since  1987.  Potentially,  compliance  with  an  OEL  provides  an  opportunity  for  industry  to 
demonstrate to workers and others that the necessary measures to address the risks of handling 
this chemical agent are in place. 

Impact on Member States and proportionality 

In the case of RCS, 11 Member States have no OEL or have one that is less stringent than the 
ACSH recommended 0.1 mg/m3 level.  Figure 24 in the annex 9 illustrates the ranges of existing 
national OELs compared to Option 2. Figure 25 shows distribution of exposed workers across 
the Member States. 

33%  of  exposed  workers  are  estimated  to  work  in  those  11  MS.  Under  such  circumstances  a 
minimum  basis  of  protection  against  the  risks  arising  from  workers'  exposure  to  these 
carcinogens cannot be ensured for all EU workers under the baseline scenario – it follows that 
an action taken at the European Union level to achieve this objective would be justified. 

5.11  Vinyl Chloride Monomer (VCM) 

Exposure  to  VCM  is  associated  with  increased  risks  of  the  usually  rare  form  of  liver  cancer, 
angiosarcoma, and possible increased risks of hepatocellular carcinomas. VCM is classified as a 
Group 1 carcinogen by IARC, and as Cat 1 carcinogen in the EU under the classification and 
labelling legislation. An OEL of 3 ppm is currently in place at EU level. 
95% of VCM104 produced worldwide is used in the manufacture of Polyvinyl Chloride (PVC) 
and  its  associated  polymers.  The  latter  is  then  used  to  manufacture  automotive  parts  and 
accessories,  furniture,  packaging  materials,  pipes,  wall  coverings,  and  wire  coatings.  VCM 
production is often located on the same site as the production of PVC. In 2007, 7.2 mln tons of 
VCM were produced in the EU and Norway in 30-40 plants located in 13 EU Member States105 
and Norway. In total, there are approximately 100 VCM manufacturing or polymerisation sites. 
There are no substitutes to VCM for VCM production. 

In  the  EU,  about  15,000  workers  from  VCM  and  PVC  plants  are  estimated  to  be  potentially 
subject to high exposure levels. No breakdown by Member State is available. Exposure to VCM 
outside  VCM  and  PVC  manufacturing  industry  is  limited, with  about  5  000  more workers (in 
manufacture of rubber and plastic products, water transport, supporting and auxiliary transport 
activity, R&D) potentially subject to (negligible) background exposure. 

The  risk  estimates  used  in  the  IOM  study  for  the  assessment  of  health  impacts  are  based  on 
evidence  provided  by  the  existing  epidemiologic  literature.  The  estimates  on  current  exposure 

103 The 'social license' concept describes ongoing approval within a local community or broad social acceptance. 
104 It  should  be  noted  that  a  targeted  REACH  restriction  applies  to  placing  on  the  market  or  use  vinyl  chloride 
(although not specified in monomer form) for use as an aerosol propellant, which is prohibited.  This restriction 
is not relevant for worker protection, and it should not be expected to affect the exposure patterns and associated 
cost benefit assessments made in this report. 

105 Belgium, Czech Republic, Germany, Spain, France, Italy, Hungary, the Netherlands, Poland, Romania, Slovakia, 

Sweden and the UK. 

70 

 
                                                 
levels  used  are  derived  from  the  existing  scientific  literature106,  and  from  exposure  data 
collected in 2008 from 36 VCM and PVC plants (a non-random sample of the around 100 plants 
present in the EU). No detailed information is available on differences in exposure levels across 
Member States. 

Table 30. Vinyl Chloride Monomer (VCM) – Types of impacts 

Impact 

Option 1 

Option 2:   

c
i
m
o
n
o
c
E

l
a
i
c
o
S

Baseline: OEL at 3 
ppm 

All firms are deemed 
to be compliant with 
the current EU OEL 
of 3ppm, with most 
VCM and PVC 
plants in the EU 
currently controlling 
VCM exposure well 
below such level. It 
is estimated that 
under the baseline 
scenario firms are 
already moving 
towards complying 
with the 1 ppm OEL.  

OEL of 1 ppm 

A large majority of firms already 
control exposure below 1 ppm. 
Currently, 25% of the plants are 
estimated to have 90th percentile 
exposure above 1ppm. The costs 
of upgrading equipment to meet 
the 1ppm exposure limit could be 
up to €2.5mln per VCM/PVC 
production site.  

The concerned plants would be 
located mainly in Czech Republic, 
Romania, Slovakia, Hungary and 
Poland.  

Investment is expected to occur 
already under the baseline, only 
possibly later in time: the 
additional costs of anticipating 
this expenditure by 10 years – 
2010 vs 2020 would be in the 
range of EUR 4-8 mln (€2-3mln if 
no additional shutdowns). 

Total attributable 
deaths for 2010-
2069: 300. Total 
YLLs: 4,270. Total 
DALYs: 4,350. 

Total attributable deaths for 2010-
2069: 300. Total YLLs: 4,220 (50 
less than the baseline). Total 
DALYs: 4,300 (50 less than the 
baseline). 

Net health benefits compared to 
the baseline are estimated to be 
between € 1-4 mln. 

The total cancer-
related health costs 
over a 60-year period 
are estimated to be in 
the range of EUR 
194-472mln. 

Option 4:   

OEL of 2 ppm 

A very large majority of 
firms already control 
exposure below 2 ppm. 
Currently, only 6% of the 
plants are estimated to have 
90th percentile exposure 
above 2ppm. The costs of 
upgrading equipment to meet 
the 2ppm exposure limit 
could be up to €0.25mln per 
VCM/PVC production site.  

Investment is expected to 
occur already under the 
baseline, only possibly later 
in time: the additional costs 
of anticipating this 
expenditure by 10 years – 
2010 vs 2020 would be 
below € 1 mln. 

Total attributable deaths for 
2010-2069: 300. Total YLLs: 
4,250 (20 less than the 
baseline). Total DALYs: 
4,330 (20 less than the 
baseline). 

Net health benefits are 
estimated to be €1-2mln. 

Environm
ental 

None. 

None. 

None. 

Option 2 would be the most effective option in reducing occupational exposure to carcinogens 
and levelling the playing field across the EU. It also leads to the highest reduction of Years of 
Life  Lost  and  Disability  Adjusted  Life  Years.  Already  under  the  baseline  the  majority  of 
companies is able to control exposure under the 1ppm exposure level, but option 2 would imply 

106 A summary of results of VCM exposure studies in the EU is reported in the IARC monograph on vinyl chloride, 

vol. 97, 2008. 

71 

 
 
 
 
                                                 
that those enterprises who are not currently below that level would no longer be able to delay 
investment  to  introduce  preventative  measures  and  effectively  minimise  exposure.  There  is  a 
ready market for VCM and no plant closures are expected to result from the implementation of a 
more stringent OEL. 

Table 31. Vinyl Chloride Monomer (VCM) – Comparison of options 

Criteria 

Option 1: 

Baseline: OEL at 
3 ppm 

Option 2: OEL at 1 
ppm 

Option 4:  OEL at 2 ppm 

Effectiveness 

Efficiency 

Coherence 

0 

0 

0 

++ 

≈/- 

+ 

+ 

≈ 

+ 

Scientific advice 
(SCOEL) 

A continuous exposure for working life to 1ppm vinyl chloride would be 
associated with a cancer risk for hepatic angiosarcoma of about 0.3 x 10-3. 

ACSH 

Agreed limit = 1 ppm. 

Option 2 is the most effective and the closest to the limit recommended by SCOEL. In addition, 
this  is  the  level  that  has  been  agreed  at  ACSH  discussions.  Some  MS  have  already  imposed 
nationally  a  similar  OEL,  and  there  are  no  concerns  regarding  technical  feasibility.  The  same 
OEL is already in place in the US and Canada. 

Impact on Member States and proportionality 

In the case of VCM, 25 Member States have so far opted to set a limit which is less protective of 
worker  health  than  the  ACSH  recommended  1  ppm.  Figure  26  in  the  annex  9  illustrates  the 
ranges of existing national OELs compared to Option 2. 

There is insufficient data to provide a breakdown by Member State. However, given the number 
of  Member  States  with  higher  OELs,  a  minimum  basis  of  protection  against  the  risks  arising 
from  workers'  exposure  to  these  carcinogens  cannot  be  ensured  for  all  EU  workers  under  the 
baseline scenario – it follows that an action taken at the European  Union level to achieve this 
objective could be justified. 

5.12  Bromoethylene (vinyl bromide) 

Bromoethylene may cause liver cancer.  

Bromoethylene  is  used  as  a  flame  retardant  in  the  production  of  acrylic  fibres  carpet  backing 
materials. Other uses include children’s sleepwear and home furnishings. 

Number of people exposed in the EU likely to be small, i.e. less than a few hundred, but there is 
not enough information to assess the actual extent of exposure. Given the uncertainty about the 
number of exposed workers it is not possible to provide a health impact assessment. Similarly, 
there are no estimates of health costs of inaction for this chemical agent. 

72 

 
 
 
 
 
Table 32. Bromoethylene (vinyl bromide) – Types of impacts 

Impact  Option 1 

Option 2 

Option 4 

Baseline - no OEL 

OEL of 1 ppm 

OEL of 5 ppm 

on 

the 

in  exposure 
judged 

(no data) 
Based 
available 
measurements  and  the  annual 
the 
reduction 
consultant 
that 
occupational  exposure  levels 
are  currently  low,  with  the 
highest  exposures  probably 
about  3  mg/m3  (less  than  1 
ppm). 

c
i
m
o
n
o
c
E

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

l
a
i
c
o
S

l
a
t
n
e
m
n
o
r
i
v
n
E

employee 

It  is  assumed  that  exposures 
fall  by  7%  per  year  in  the 
future. 
Therefore,  there  are  expected 
to  be  some  costs  to  firms 
where 
bromoethylene 
exposure  occurs  to  put  into 
training, 
place 
Personal  protective  equipment 
(PPE) 
ventilation 
measures  to  reduce  inhalation 
that 
and  dermal  exposure 
would  regardless  of  further 
interventions  over  the  period 
2010 – 2069  
There are not expected to be 
any noticeable social impacts 
under the baseline scenario at 
an EU level. 

and 

 There is insufficient 
information to calculate the 
health impacts expected under 
the baseline. 

There are not expected to be 
any noticeable environmental 
impacts under the baseline 
scenario at an EU level. 

It  is  estimated  that,  under  the 
baseline  scenario,  firms  are 
already  achieving  exposures 
less than 5 ppm. 
Therefore 
not 
there 
expected  to  be  any  significant 
additional  costs  of  meeting  an 
OEL  of  5  ppm  relative  to  the 
baseline scenario. 

are 

There are not expected to be 
any noticeable change to the 
number of workers required as 
a result of introducing an EU-
wide OEL.  

No health costs and no health 
benefits are expected. 

No workers exposed to 
bromoethylene are estimated 
to be exposed above the 
possible EU-wide OEL of 5 
ppm, and therefore most 
workplaces are unlikely to be 
affected / require further 
changes to their existing 
working practice. Therefore 
there are not estimated to be 
any significant changes in 
environmental impacts. 

Based  on  the  available  measurements  and  the  annual  reduction  in  exposure  the  consultant 
judged  that occupational exposure levels  to  bromoethylene are currently low,  with  the highest 
exposures probably about 3 mg/m3 (less than 1 ppm). 

There are no predicted health benefits from setting an OEL at 5 ppm, although it can be assumed 
that  the impact would be relatively small  because  current  exposures  are estimated to  be much 
lower than 5 ppm. There are no additional costs associated with compliance with an OEL of 5 
ppm.  There  are  also  no  social  or  macro-economic  costs  associated  with  introducing  such  an 
OEL. There are no significant environmental impacts foreseen. Lack of data for option 2 does 
not allow assessing its impacts. 

73 

 
 
 
 
 
 
 
 
 
 
 
Table 33. Bromoethylene (vinyl bromide) – Comparison of options 

Criteria 

Option 1 

Baseline 

Option 2 

Option 4 

1 ppm 

5 ppm 

Effectiveness 

Efficiency 

Coherence 

Scientific 
advice 
(SCOEL) 

ACSH 

0 

0 

0 

(++) 

(+) 

(++) 

≈ 

≈ 

+ 

SCOEL recommends to use the existing quantitative risk assessment for vinyl 
chloride (SCOEL/SUM/109) also for vinyl bromide (bromoethylene), considering a 
three times higher potency of vinyl bromide compared to vinyl chloride. 

OEL of 1 ppm is proposed following the SCOEL recommendation for vinyl chloride, 
the carcinogenic effects of which are similar to vinyl bromide. 

The opinion of the social partners and Member States in the ACSH supports option 2, and the 
CMD  further  establishes  an  expectation  that  OELs  be  set  where  it  is  possible  to  do  so. 
Introducing  an  OEL  would  also  be  effective  in  introducing  a  greater  clarity  for  economic 
operators across the EU. At the same time, lack of data does not allow to assess costs/benefits 
options 2 (ACSH value). 

Impact on Member States and proportionality 

In the case of bromoethylene 22 Member States have no OEL for this agent or have one that is 
less  stringent  than  the  value  recommended  by  ACSH,  so  introduction  of  an  OEL  of  1  ppm 
would  require  changes  for  a  substantial  number  of  MS.  Figure  27  in  Annex  9  illustrates  the 
ranges of existing national OELs compared to Option 2. 

There  is  no  data  on  numbers  of  exposed  workers  per  Member  State  but  it  is  possible  that  the 
overall number of exposed workers in the EU is close to zero. An action taken at the European 
Union  level  to  achieve  this  objective  could  be  justified  as  a  way  to  ensure  minimum  basis  of 
protection against the risks arising from workers' exposure to this carcinogen. 

5.13  Hydrazine 

Exposure  to  hydrazine  may  increase  the  risk  of  lung  and  colorectal  cancer.  It  is  classified  by 
IARC as a Group 2B carcinogen (Possibly carcinogenic to humans), and as a Cat 1B carcinogen 
in the EU under the classification and labelling legislation. 

The principal applications of hydrazine solutions include chemical blowing agents, agricultural 
pesticides  and  water  treatment.  Production  levels  in  Europe  are  estimated  to  be  around  20-25 
thousand  tonnes  per  year,  and  in  the  EU  the  largest  producers  of  hydrazine  are  Germany  and 
France. 

The  risk  estimates  used  in  the  IOM  study  for  the  assessment  of  health  impacts  are  based  on 
existing epidemiologic evidence. Estimates of exposure prevalence in the manufacture of basic 
chemicals  for  the  EU  were  based  on  2009  exposure  prevalence  data  available  for  Finland 
(although the Finnish exposure prevalence data may not be applicable to all EU countries). As 
data  on  exposure  prevalence  in  agriculture  is  not  available,  it  is  assumed  that  exposure 
prevalence is similar to that of fungicide captafol (based on Italian 2005 data). 

74 

 
 
 
 
 
Data on possible current exposure levels is extremely limited (the most recent data available is 
from  1998  for  Japan).  Assuming  a  declining  trend  in  exposure  of  7%  per  year,  the  assumed 
(upper) estimate of current exposure for high, medium and low group industries are of 0.7, 0.1 
and 0.06 mg/m3, respectively. 

In the EU, about 2,1 mln workers are estimated to be exposed to low levels of hydrazine, about 
14,600  to  medium  levels  (in  agriculture)  and  833  to  high  levels  (in  manufacturing  of  basic 
chemicals). Overall, it is considered that about 8% of workers are exposed above 0.13 mg/m3, 
and about 75% above 0.013 mg/m3. 

Cost estimates include exposure control measures undertaken by firms in the manufacturing of 
basic chemicals and in agriculture. As the number of firms potentially affected is not known, an 
estimate  is  derived  on  the  basis  of  the  (estimated)  number  of  workers  potentially  exposed, 
combined  with  the  available  information  on  firm  distribution  by  size.  For  agriculture,  it  is 
expected that the costs related to use of hydrazine as a herbicide can be controlled through good 
practice and use of appropriate personal protective equipment (PPE). No significant additional 
costs  are  therefore  expected,  as  the  latter  is  already  considered  to  be  good  practice.  In  the 
manufacturing of basic chemicals, the installation of new local exhaust systems (LEVs) may be 
required  by  some  firms  to  ensure  compliance.  Estimates  on  the  number  of  firms  potentially 
affected are subject to high uncertainty. 

Table 34. Hydrazine – Types of impacts 

Impact 

Option 1 

Option 2: 
OEL at 0.013 mg/m3, Sk. 

Option 4:   
OEL at 0.13 mg/m3, Sk. 

c
i
m
o
n
o
c
E

l
a
i
c
o
S

Baseline - no OEL 

Under the baseline 
scenario, there is 
estimated to be a 
reduction of exposure at 
an annual rate of 7% until 
2030 towards 
0.013mg/m3 and below.  
These estimates include 
costs for PPE in 
agriculture, as well as  
some investment in 
LEVs. 

In total there is expected to be 
around 2,100 firms in 
agriculture and manufacturing 
of basic chemicals affected by 
an OEL at 0.013mg/m3. 

No additional significant 
costs for firms vs. the 
baseline are expected. Once 
the decline in exposure levels 
under the baseline is factored 
in, the resulting additional 
total costs for complying with 
the OEL would be in the 
range of €5-32 mln. 

Total attributable deaths 
for 2010-2069: 710. Total 
YLLs: 10,370. Total 
DALYs: 12,340. 

Total attributable deaths for 
2010-2069: 710. Total YLLs: 
10,370. Total DALYs: 
12,340.  

Total cancer-related 
health costs for the 60-
year period are estimated 
to be between €0.5 to €3 
bln. 

Net health benefits are 
estimated to be between 
€0.01-0.05 mln. 

In total there is expected to 
be around 420 firms in 
agriculture and 
manufacturing of basic 
chemicals affected by an 
OEL at 0.13mg/m3. 
No additional significant 
costs for firms vs. the 
baseline are expected. Once 
the decline in exposure 
levels under the baseline is 
factored in, the resulting 
additional total costs for 
complying with the OEL 
would be in the range of €2-
12 mln.  
Total attributable deaths for 
2010-2069: 710. Total 
YLLs: 10,370. Total 
DALYs: 12,340.  

Net health benefits are 
estimated to be between €0-
0.02 mln. 

Environ
mental 

None. 

None. 

None. 

75 

 
 
 
 
 
Option 2 would be the most effective option in reducing occupational exposure to carcinogens 
and  levelling  the  playing  field  across  the  EU  (as  some  MS  already  have  set  OELs  at  0.013 
mg/m3). In terms of compliance costs, in agriculture the costs related to use of hydrazine as an 
herbicide  can  be  controlled  the  use  of  appropriate  personal  protective  equipment,  which  is 
considered already as good practice. In manufacturing, no significant additional costs (vis-à-vis 
option  1)  are  expected  since  the  costs  associated  with  purchase,  maintenance  and  use  of  local 
exhaust  systems  would  have  been  incurred  in  any  case  under  the  baseline  scenario,  only 
possibly more gradually over time. 

Where there is the possibility of a significant uptake via dermal exposure SCOEL recommend 
that  any  OEL  be  accompanied  by  a  'skin  notation'  (in  the  case  of  hydrazine  ACSH  did  not 
comment  on  this  aspect  of  the  SCOEL  Recommendation).    If  adopted  and  accordingly 
transposed by Member States, employers are required under the national transposing legislation 
to take this into account in selecting appropriate risk management measures to protect workers. 

Once the need for managing exposure has been established the only risk management measure 
available in practical terms is to avoid skin contact. Hydrazine has a harmonised classification as 
corrosive  to  the  skin  (category  1B)  and  skin  sensitiser  (category  1).  These  hazards  would 
normally  result  in  employers  taking  steps  to  avoid  skin  contact  as  a  part  of  routine  OSH  risk 
control.  Adoption of a 'skin notation' should therefore result in no additional cost for employers. 

Table 35. Hydrazine – Comparison of options 

Criteria 

Option 1: 

Baseline: no OEL  

Option 2:  

OEL at 0.013 
mg/m3, Sk. 

Option 4:  
OEL at 0.13 mg/m3, Sk. 

Effectiveness 

Efficiency 

Coherence 

0 

0 

0 

+ 

≈ 

+ 

≈ 

≈ 

+ 

Scientific advice 
(SCOEL) 

Categorised as a genotoxic carcinogen for which the existence of a threshold cannot 
be sufficiently supported. 

The systemic effects seen in animals following dermal contact warrant a 'skin 
notation'. 
0.013 mg/m3.  

ACSH 

Some Member States have  already imposed  nationally an  OEL of 0.013  mg/m3, and there are 
few  concerns  regarding  technical  feasibility.  Compliance  costs  are  small,  not  hampering 
production processes nor business viability. 

The opinion of the social partners and Member States in the ACSH supports option 2, and the 
CMD  further  establishes  an  expectation  that  OELs  be  set  where  it  is  possible  to  do  so. 
Introducing  an  OEL  would  also  be  effective  in  introducing  a  greater  clarity  for  economic 
operators across the EU. At the same time, option 2 brings only a minor benefit, accompanied 
by a limited cost for enterprises. 

Impact on Member States and proportionality 

In the case of hydrazine 24 Member States have no OEL for this agent or have one that is less 
stringent  than  the  value  recommended  by  ACSH,  so  introduction  of  an  OEL  of  0.013  mg/m3 
would require changes for a substantial number of MS. The Figure 28 in the annex 9 illustrates 
the  ranges  of  existing  national  OELs  compared  to  Option  2.  Figure  29  in  Annex  9  shows 
distribution of exposed workers across the Member States. 

76 

 
 
It is estimated that approximately 91% of exposed workers are located in those Member States. 
An action taken at the European Union level could improve legal protection of exposed workers. 

5.14  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: 

i) Stakeholders' acceptance 

For  all  the  considered  carcinogens  the  stakeholders  represented  in  the  ACSH  support  the 
retained options. 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. 

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 

Introduction  of  OELs  for  all  the  considered  chemical  agents  will  improve  legal  clarity  for 
employers  and  workers.  For  some,  however,  the  effect  will  be  more  significant  as  currently 
fewer MS have introduced OELs corresponding to the advised level. 

- 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  an 
introduction of an OEL will be useful even if currently few workers are exposed (in the future, 
due to new uses of the chemical agents this might change), 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 

iv) Health benefit 

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

- XXX - benefits over 100 mln EUR 
- XX - benefits between 10 mln EUR and 100 mln EUR 
- X - benefits of less than 10 mln EUR 

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 mln EUR 
- XX - costs between 10 and 100 mln EUR 
- X - costs over 100 mln EUR 

77 

 
 
 
 
Table 36 

Name of the 
chemical agent 

Retained option 

 (ppm – parts per 
mln, mg/m3 or 
f/ml - fibres per 
ml) 

Stakeholders 
acceptance 

Legal 
clarity 

Size of the 
problem 

Health 
benefit 

Limited 
costs for 
business 

1,2 
Epoxypropane 
1,3 Butadiene 
2 Nitropropane 
Acrylamide 
Hardwood dust 
Chromium (VI) 
compounds  
Ethylene oxide 
o-Toluidine 
Refractory 
Ceramic Fibres 
(RCF) 
Respirable 
Crystalline 
Silica 
Vinyl chloride 
Bromoethylene 
(Vinyl bromide) 
Hydrazine  

1 ppm  

1 ppm  
5 ppm  
0.1 mg/m3  
3 mg/m3 
0.025 mg/m3 

1 ppm  
0.1 ppm 
0.3 f/ml  

0.1 mg/m3 

1 ppm 
1 ppm  

0.013 mg/m3 

XX 

XX 
XX 
XX 
X107 
X108 

XX 
XX 
X109 

X110 

XX 
XX 

XX 

XX 

XX 
XX 
X 
XX 
XX 

X 
XX 
XX 

X 

X 

X 
XX 
XX 
XXX 
XXX 

X 
X 
X 

X 
X 
X 
XX 
XXX 

X 
X 
X 

XXX 

XX 
XXX 
XXX 
XXX 
X 

XXX 
XXX 
XXX 

X 

XXX 

XXX 

X 

XX 
XX 

XX 

X 
n/a 

XXX 

X 
X 

X 

XXX 
XXX 

XX 

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 follows: 

107 ACSH agreed on an OEL of 3 mg/m3. However, during discussions, employers emphasised that some hand-held 
machinery does not allow going below 5 mg/m3. On the other hand the workers favoured a 2 mg/m3. For some 
MS, 3 mg/m3 is at the limit of feasibility particularly for SMEs while other MS favour a 1 mg/m3 limit to further 
reduce occupational cancer cases. 

108 

ACSH agreed on an OEL of 0.025 mg/m3. However, during discussions, workers group argued that even a 
binding limit of 0.025 mg/m3 would correspond to a high cancer risk. Employers' representatives did not make 
any specific comments in the ACSH opinion. 

109 

ACSH agreed that an OEL was necessary but could not reach agreement on exact value (between 0.3 f/ml 
and  0.1  f/ml).  Employers  advised  to  follow  the  recommendation  of  SCOEL  (0.3  f/ml).  They  also  stress  that 
industries have been working on a 0.5 f/ml exposure limit for many years, and further reductions of exposure are 
technically difficult. Views of Member States ranged from 0.3 f/ml to 0.1 f/ml. The workers argued for an OEL 
0.1f/ml. An OEL of 0.3 f/ml was taken forward in the proposal as the minimum common denominator. 

110 

ACSH agreed that a binding OEL at 0.1 mg/m3, measured as respirable dust, is justified. The value should 
be  reviewed  within  3-5  years.  There  were  some  questions  on  the  part  of  employers  and  some  MS  whether  it 
would not be more appropriate to legislate under the CAD. Workers stated that further exposure reduction below 
the proposed binding OEL of 0.1 mg/m³ is paramount to reduce the risks of lung cancer, and silicosis. 

78 

 
 
 
 
                                                 
  Respirable  Crystalline  Silica:  an  OEL  at  0.1  mg/m3  will  provide  for  99,000  avoided 
cancer cases by 2069 for a total monetized health benefit quantified between 34 billion 
and 89 billion EUR; 

  Hardwood  dust:  an  OEL  of  3  mg/m3will  provide  for  a  total  monetized  health  benefit 

between 12 million and 54 million EUR; 

  Benefits  are  also  expected  in  relation  to  introducing  a  OEL  at  0.025  mg/m3  for  all 
chromium (VI) compounds, although it is likely these will have been overestimated as a 
result of reductions in exposure which may be expected for some important compounds 
when subject to REACH authorisation.  

  Remaining substances: The avoided cancer cases and the monetized health benefits are 

less significant.  

The  introduction  of  retained  option  would  decrease  the  burden  of  economic  costs  derived  by 
workers' exposure to hazardous substances. The main economic costs caused by disability and 
premature death at work are: 

 
 

the worker’s lost wages during the period of absence from work; 
the subsequent severe consequences for household's well-being as well as a reduction in 
tax collection. 

By  acting  as  a  clear  and  homogeneous  playing  field  for  workers'  rights  enforcement,  the 
introduction of the retained option will reduce health and safety risks for disadvantaged workers 
such as precarious and informal workers. The scientific literature (Aronsson, 1999; Quinlan and 
Mayhew, 2000; Letourneux and Thebaud-Money, 2002) agrees in pointing out that precarious 
workers have less control over fundamental determinants of their health and safety such as: the 
ability  to  change  temperature,  lighting,  ventilation,  and  work  location,  and  the  freedom  to 
choose when to take personal leave; and they are also more likely to be employed in dangerous 
working environment. 

As  a  consequence,  the  retained  option  have  the  advantage  of  shielding  workers  and  families 
from suffering financial and social costs which would otherwise occur in a baseline scenario. 

It  is  important  to  note  that  the  study  underlying  the  Impact  Assessment  report  was  limited  to 
assessing  health  benefits  resulting  solely  from  avoided  cancer  cases.  However,  the  chemical 
agents under consideration cause a range of other occupational diseases. These include primarily 
different  forms  of  respiratory  diseases  (caused  e.g.  by  hardwood  dust,  RCS,  RCF)  and 
dermatological diseases (e.g. acrylamide, RCF). Enhanced workplace control of exposure to the 
considered  chemical  agents  will  also  contribute  to  decreasing  the  risk  of  those  occupational 
diseases.  

The  available  data  is  not  sufficient  to  estimate  the  magnitude  of  related  health  benefits. 
However,  taking  into  account  general  estimates  of  costs  related  to  these  diseases,  it  could  be 
expected that limiting the risks leading to their onset could be considerable. 
Concerning occupational asthma, according to a review of existing research111, costs are related 
to  the  poor  prognosis  of  the  disease  and  small  chances  for  recovery.112    Estimated  70%  of 
workers diagnosed with occupational asthma show symptoms even several years after complete 
cessation of exposure113. According to estimates of the direct and indirect costs of occupational 
asthma in the United Kingdom114, the average annual direct costs per case are £530-£715. The 

111 Montano  D.  Chemical  and  biological  work-related  risks  across  occupations  in  Europe:  a  review.  Journal  of 

Occupational Medicine and Toxicology (London, England). 2014;9:28. doi:10.1186/1745-6673-9-28. 

112 Mapp  CE,  Boschetto  P,  Maestrelli  P,  Fabbri  LM.  Occupational  Asthma.  Am  J  Respir  Crit  Care  Med. 

2005;172(3):280–305. [PubMed] 

113 Tarlo SM, Lemiere C. Occupational asthma. New Engl J Med. 2014;370(7):640–649. [PubMed] 
114 Ayres JG, Boyd R, Cowie H, Hurley JF. Costs of occupational asthma in the UK. Thorax. 2011;66(2):128–133. 

79 

 
                                                 
annual indirect costs range from £1525 to £1685. The total costs of an average case to society is 
some £120,000-£130,000. The total lifetime costs of new cases to society could lie between £95 
and £135  million. Further research showed that some 49%  of the present value total costs are 
borne by the individual, 48% by the state and only 3% by the employer.115 

On the subject of occupational skin diseases the same research review quotes a study on costs of 
occupational  hand  eczema,  conducted  in  2013  in  Germany.116  The  annual  direct  and  indirect 
costs per worker diagnosed and treated were on average 2646 and 6152 EUR, respectively. An 
Italian study estimated societal costs of severe chronic hand eczema to be on average 5016 EUR 
per  person-year  (min.  411  EUR,  max.  27648  EUR).117  The  need  to  conduct  occupational 
retraining,  job  change,  or  adverse  psychosocial  effects  result  in  further  costs.118  As  for  severe 
occupational  skin  diseases  more  than  a  half  of  all  cases  may  become  persistent  and  continue 
even  after  exposure  to  a  chemical  agents  discontinued,  further  direct  and  indirect  costs  might 
occur  depending  on  the  degree  of  disability.119,120  Also  research  conducted  in  Australia 
confirmed  that  occupational  skin  diseases  had  a  significant  socioeconomic  impact,  with  an 
estimated annual cost of over $33 million.121 

6.2 

Impact on businesses 

From  an  economic  standpoint,  the  total  cost  to  an  economy  of  occupational  morbidity  and 
mortality is the sum of all private economic costs that are also social costs, plus the social costs 
that are external to all private parties. Thus, the illness of a worker results in lost output for the 
employer. If the worker is paid during the period of non-production, this mitigates the private 
cost to the worker but increases the cost to the employer. A loss of production may lead to a loss 
of  profits,  which  would  then  be  a  social  as  well  as  private  cost,  but  the  firm  might  have  the 
ability to raise prices, maintain profits, and shift the cost to consumers. 

As  regards  the  economic  impacts  on  costs  incurred  by  enterprises  for  some  carcinogens,  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 Chromium 
(VI) compounds and RCS. As regards RCS, the total costs to industry of introducing an OEL at 
0.1 mg/m3 are estimated to be at 3.5 bln EUR until 2069122. 

For the remaining carcinogens, the impact on operating costs and conduct of business (including 
small and medium enterprises) will 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. 

115 Assessing  the cumulative  economic  impacts  of  health  and  safety  regulations  -  Scoping  study.  Prepared by  the 

Centre for Strategy & Evaluation Services (CSES) for the Health and Safety Executive 2009) 

116 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] 

117 Cortesi PA, Scalone L, Belisari A, Bonamonte D, Cannavo SP, Cristaudo A, Pita Od, Gallo R, Giannetti A, Gola 
M, Pigatto PD, Mantovani LG. Cost and quality of life in patients with severe chronic hand eczema refractory to 
standard therapy with topical potent corticosteroids. Contact Dermat. 2013;70(3):158–168. [PubMed] 
118 Diepgen TL, Kanerva L. Occupational skin diseases. Eur J Dermatol. 2006;16(3):324–330. [PubMed] 
119 Rycroft  R,  Frosch  P.  In:  Contact  Dermatitis,  4  edition.  Frosch  P,  Menne  T,  Lepoittevin  JP,  editor.  Berlin: 

Springer; 2006. Occupational contact dermatitis; pp. 717–734. 

120 Sajjachareonpong P, Cahill J, Keegel T, Saunders H, Nixon R. Persistent post-occupational dermatitis. Contact 

Dermat. 2004;51(5–6):278–283. [PubMed] 

121 http://www.safeworkaustralia.gov.au/sites/swa/media-events/media-releases/pages/mr16032012 
122 Estimated costs of anticipating investment needed to reach the exposure level. 

80 

 
 
                                                 
It is important, from an economic point of view, to distinguish between costs that do or do not 
create  incentives  for  improvements  in  health  and  safety.  The  advantages  for  businesses  of 
introducing  EU  wide  OELs  is  that  the  new  regulation  will  help  firms  addressing  costs  which 
would, otherwise, negatively affect their business prospect in the long-term in the case of non-
compliance. According to the economic literature these costs are: 

  Economic - in this case these costs include unequal firms' costs related to differences in 
the rate of depreciation of capital equipment or loss of raw material due to the existence 
of different national OEL; in addition there are 'opportunity costs' – for instance if a firm 
loses  market  share  due  to  worker  absences  from  ill-health;  finally,  company's  loss  of 
'goodwill',  which  may  result  from  well-publicized  cases  of  industrial  accidents  or 
disease, this is an opportunity cost to the firms which can have serious consequences; 

 

Internal – if retained options are not adopted the enterprise run the risk to be considered 
accountable for workers' ill-health; 

  Variable  –  the  cost  derived  by  workers'  ill-health  might  not  simply  resolve  in  a  fixed 

premium compensation but might involve longer-term costs for the firm; 

  Routinely  visible  –  cost  derived  by  non-adoption  of  EU-wide  OELs  would  increase 
firms'  exposure  to  expensive  process  of  legal  and  economic  information  acquisition  to 
deal with the consequences of workers' ill-health. 

6.2.1 

Impact on SMEs 

None  of  the  considered  options  contain  lighter  regimes  for  SMEs.  SMEs  are  not  exonerated 
from  the  obligation  to  eliminate  or  reduce  to  a  minimum  the  risks  arising  from  occupational 
exposure to carcinogens or mutagens. 

For many of the agents covered in this impact assessment, OELs exist already at national level, 
even if the level as such differs between the EU Member States. 

Establishing the OELs foreseen in this initiative should have no impact on those SMEs situated / 
located in those EU Member States were the national OELs are either equal or lower than the 
proposed values. 

However,  due  to  differences  in  OELs  at  national  level  there  will  in  some  cases  depending  on 
industry  practice  be  an  economic  impact  in  those  Member  States  (and  economic  operators 
established  therein)  which  currently  have  higher  OELs  established  for  the  chemical  agents 
subject to the initiative. 

The  major  economic  impact  for  SMEs  can  be  summarised  in  three  points.  First,  some  of  the 
OELs have  overhead  costs, and the smaller  the firm, the smaller the revenue  base over which 
these  costs  can  be  distributed.  Second,  the  level  of  expertise  is  frequently  lower  for  SMEs. 
Third,  the  SMEs  environment  is  generally  more  competitive  and  finance  is  more  difficult  to 
obtain,  leading  to  shorter  time  horizons  and  fewer  expenditures  on  what  may  be  perceived  as 
nonessential  items  different  spending  priorities  –  potentially  reducing  voluntary  investment  in 
equipment or training which may be necessary to implement effective risk management. 
The majority of companies that would be affected by the imposition of a RSC limit at 0.1 mg/m3 
are  small  companies.  If  the  costs  cannot  be  passed  through  to  consumer  prices  and/or  some 
companies will not be able to get access to loans to pay for the necessary investment, there is a 
possibility  of  some  company  closures  and,  for  industries  for  which  it  is  possible,  some 
relocation of activities in non-EU countries. The extent of this risk is difficult to estimate. 17 EU 
Member States have already introduced an OEL of 0,1 mg/m3 or below and also from this point 
of view it appears to be feasible for the industry to adjust to such an exposure limit. Most of the 
costs  incurred  in  relation  to  it  will  be  incurred  by  the  construction  industry,  in  which  case 
relocation  is  not  a  viable  option,  so  companies  are  likely  to  pass  the  additional  costs  on  to 

81 

 
consumers  to  some  extent.  The  fact  that  a  majority  of  MS  already  have  introduced  the  OEL 
under consideration and that the same level exists in non-EU countries such as the US, Canada 
or Australia, indicate that it should be feasible for the sectors concerned to absorb the additional 
costs. 

For chromium VI the IOM study assessed that the costs of compliance will notably affect small 
firms  employing  less  than  20  people,  particularly  in  the  manufacture  of  fabricated  metal 
products. It is possible that some could either close or cease to use chromium (VI) containing 
components. However, those estimates are for all Chromium (VI) compounds and, as a result of 
anticipated exposure  reductions  resulting  from  the  impact  of  REACH  authorisation  on  several 
important compounds,  both  the costs and benefits can  be expected to  be overestimated. These 
figures  nevertheless  represent  the  best  and  most  appropriate  available  data  to  inform  this 
analysis. 

SMEs indicated that OSH legislation in general creates some burdens, particularly in relation to 
documenting  risk  management  and  reporting  obligations  (even  if  there  is  evidence  that  some 
burdens might be related to national transposition rather than EU level legislation).123 One of the 
goals  of  a  future  revision  of  the  OSH  acquis  may  be  to  simplify  and/or  reduce  administrative 
costs,  including  for  micro  and  small  enterprises  CMD  limit  values  do  not,  however,  result  in 
additional reporting or documenting obligations and the clarifications provided in Annexes I and 
III should in fact decrease the burden on employers by providing clear guidance as for the scope 
of application and the level of expected compliance. 

Moreover, the European Association of Craft, Small and Medium-Sized Enterprises (UEAPME) 
was  among  signatory  parties  of  the  Cross  Industry  initiative,  which  recognised  'EU-wide 
Occupational  Exposure  Limits  (OELs)  as  the  most  effective  risk  management  option  for 
substances where there is a need to address a risk limited to the workplace' and called for the 
Commission and Member States 'to proceed to set EU-wide OELs for substances, where a risk is 
identified at the workplace'.124 

6.2.2 

Impact on competition and competitiveness 

Risk prevention and the promotion of safer and healthier conditions in the workplace are key not 
just  to  improve  job  quality  and  working  conditions,  but  also  to  promoting  competitiveness. 
Keeping  workers  healthy  has  a  direct  and  measurable  positive  impact  on  productivity,  and 
contributes  to  improving  the  sustainability  of  social  security  systems.  There  is  a  correlation 
between  low  levels  of  a  country's  rating  as  regards  work-related  deaths  and  diseases  and  its 
competitiveness rank.125 

Implementing  the  retained  option  would  have  a  positive  impact  on  competition  within  the 
internal  market.  Having  EU-wide  OEL  for  those  agents  will  decrease  competitive  distortion 
between  firms  located  in  Member  States  with  different  national  OELs.  Setting  a  minimum 
standard at EU level will not (and should not) prevent Member States from setting even more 
protective OELs. However, it will provide certainty that there is an enforceable exposure limit 
for all concerned carcinogens in all Member States. It will also significantly minimise the scope 
for variation in OELs across the EU. It may be noted that the examples of the current hardwood 
dust  and  VCM  OELs  show  that  a  majority  of  Member  States  in  practice  adopt  the  EU  OEL 
directly. 

On  the  other  hand,  the  retained  option  should  not  have  a  significant  impact  on  the  external 
competitiveness  of  EU  firms  as  many  of  the  values  proposed  are  similar  to  those  in  other 

123 Commission follow-up to the 'Top Ten' Consultation of SMEs on EU Regulation (COM(2013) 446) 
124 Further information on the initiative and source are provided in section 4.2.D. 
125 Jukka  Takala  et  al.:  Global  Estimates  of  the  Burden  of  Injury  and  Illness  at  Work  in  2012,  available  online: 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4003859/ 

82 

 
                                                 
countries (see Table 3 in  Annex 6), notably EU largest trading partners, such as US, China or 
Switzerland. For example, the proposed value for exposure to hardwood dust is 3 mg/m3 while 
the value in Canada and Australia is 1 mg/m3. The proposed value for vinyl chloride monomer 
is 1 ppm, the value in the USA and Canada is also 1 ppm. And the value of 0.1 mg/m3 proposed 
for RCS is also established in the USA, Australia and Canada. 

Furthermore,  it  is  to  be  expected  that  in  some  of  those  third  countries,  limit  values  will  also 
continue  to  be  adjusted  to  new  scientific  data.  The  US  Occupational  Safety  &  Health 
Administration  (OSHA),  for  example,  recognizes  that  many  of  its  permissible  exposure  limits 
(PELs) are outdated and inadequate for ensuring protection of worker health. Most of OSHA’s 
PELs  were  issued  shortly  after  adoption  of  the  Occupational  Safety  and  Health  (OSH)  Act  in 
1970, and have not been updated since that time.126 

6.3 

Impact on Member States/national authorities 

Where  no  EU  OEL  exists  many  Members  States  conduct  their  own  scientific  analysis  to 
determine  the  acceptable  exposure  level.  Exact  costs  of  this  type  of  exercise  are  difficult  to 
establish but would be significant given the level of scientific and technical expertise required. 
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. 

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. From an economic point of view, the coverage and adequacy of EU-wide 
OELs is the single most important determinant of who bears the cost burden of occupational ill-
health. 

Administrative  and  enforcement  costs  will  differ  according  to  present  status  of  each  chemical 
agent in each MS, but should not be significant. 

Based  on  the  experience  gathered  from  the  work  of  the  Senior  Labour  Inspectors  Committee 
(SLIC) and having regard to the way the enforcement activities are organised in different MS it 
is  not  likely  that  the  introduction  of  new  OELs  in  the  CMD  would  have  any  impact  on  the 
overall  costs  of  the  inspection  visits.  Those  are  mostly  planned  independently  of  the  revised 
legislation, mainly based on complaints filed during a given year and according to the inspection 
strategies defined by a given authority. 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. 

Additional  administrative  costs  might  be  incurred  by  authorities  as  regards  the  necessity  to 
provide  information  and  training  on  the  revision  to  staff,  as  well  as  to  revise  the  compliance 
checklists.  However,  these  costs  are  minor  in  comparison  to  the  overall  costs  of  functioning 
incurred by the enforcement authorities. 

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). 

126 https://www.osha.gov/dsg/annotated-pels/ 

83 

 
 
                                                 
6.5  How  does  the  retained  option  conform  to  the  principles  of  subsidiarity  and 

proportionality given the size and nature of the identified problem? 

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)  and  the  REACH 
Regulation. Amending Directive 2004/37/EC can only be done by action at EU level and after a 
two-stage  consultation  of  the  social  partners  (management  and  labour)  in  accordance  with 
Article 154 TFEU. 

With regard to the values proposed as retained option it has to be stressed that socio-economic 
feasibility  factors  have  been  taken  into  account  after  long  and  intensive  discussions  with  all 
stakeholders  (representatives  from  employees'  associations,  representatives  from  employers' 
associations, and representatives from governments). 

While monetised benefits of the initiative may be modest, it should be recalled that the initiative 
would contribute to saving 100,000 human lives in the forthcoming 50 years. These figures are 
based on the estimations made the IOM study contracted by the Commission127. There is a range 
of additional benefits which have not been quantified (e.g. benefits related to avoided cases of 
other  occupational  diseases  caused  by  the  chemical  agents,  positive  effects  on  level  playing 
field, facilitation of legal compliance and enforcement etc.). 

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 33% to 98% of exposed workers (see Table 4 in Annex 6). 

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.  

The planned action therefore complies with the principles of proportionality and subsidiarity. 

7  HOW WOULD ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

This section presents the monitoring and evaluation arrangements that seem most appropriate at 
this stage in order to monitor and evaluate the planned legislative initiative. It should however 
be  noted  that  the  overall  OSH  legislative  framework  has  just  undergone  a  comprehensive 
evaluation.  As  a  result  of  this,  the  Commission  might  decide  to  modify  the  monitoring  and 
evaluation mechanisms currently foreseen in this framework. This would clearly have an impact 
on  the  monitoring  and  evaluation  arrangements  of  the  individual  Directives  within  the  OSH 
framework, including the CMD. 

7.1  Monitoring arrangements  

The operational objectives for the retained option, in relation to the chemical agents covered are: 

  The  reduction  of  occupational  diseases  and  occupational  related  cancer  cases  in  the 

European Union; 

  The reduction of costs related to occupational cancer for economic operators and for 

social security systems in the European Union. 

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

127 Deaths avoided mainly in relation to the following chemical agents: Chromium VI - 1670; Refractory Ceramic 

Fibres - 50; Respirable Cristalline Silica - 98,670. 

84 

 
 
 
 
                                                 
Table 37 

Operational 
objective  

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

Indicators  

The number of 
occupational 
diseases and 
occupational 
related cancer 
cases in the EU 

The reduction of 
costs related to 
occupational 
cancer for 
economic 
operators and 
for social 
security systems 
in the European 
Union 

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

Monitoring arrangements/data sources for 
monitoring indicators  

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 
1338/2008.128 
-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 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 
on occupational cancer cases are described supra in this 
table).   

The  monitoring  of  implementation  (transposition  and  application)  is  also  an  indicator  of  the 
effectiveness of the initiative to reach its operational objectives. A compliance assessment will 
be  carried  out  for  the  transposition  of  the  limit  values,  by  the  Commission  in  two  stages:  a 
transposition check and conformity check. The monitoring of application and enforcement will 
be  undertaken  by  the  national  authorities  in  charge  of  the  protection  of  workers'  health  and 
safety  and  in  particular  the  national  labour  inspectorates.  Information  on  the  practical 
implementation of the Directive 2004/37/EC at national level is provided every five years by the 
Member  States  in  accordance  with  Article  17a  of  Directive  89/391/EEC.  At  EU  level,  the 
Committee  of  Senior  Labour  Inspectors  ('SLIC')  established  by  Commission  Decision 
95/319/EC,  informs  the  Commission  on  all  problems  relating  to  the  enforcement  of  EU  OSH 
Directives, including Directive 2004/37/EC.129 

7.2  Evaluation arrangements  

In  accordance  with  the  ex-post  evaluation  clause  in  Art.  17a  of  Directive  89/391/EEC,  every 
five  years,  Member  States  are  required  to  submit  a  single  report  to  the  Commission  on  the 
practical implementation of the EU OSH Directives. This report includes a chapter dealing with 

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

354/70, 31.12.2008. 

129 In particular, the SLIC Working Group CHEMEX is mandated to gather, exchange and disseminate information 
and  guidelines  for  national  labour  inspectorates  on  enforcement  matters  related  to  chemical  exposures  in 
workplaces, and in particular for carcinogenic, mutagenic, reprotoxic or sensitising chemical agents.   

85 

 
 
 
                                                 
the implementation of particular aspects of Directive 2004/37/EC, including specific indicators, 
where available.  On this basis, the Commission will evaluate the implementation of Directive 
2004/37/EC  in  terms  of  its  relevance,  of  research  and  of  new  scientific  knowledge,  in 
accordance with Art. 17a (4) of Directive 89/391/EEC. 

In  accordance  with  Art.  17a  of  Directive  89/391/EEC,  the  Commission  is  required,  within  36 
months of the end of the five-year period, 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 in this report it is suggested to made use of the next 
ex-post evaluation exercise to define the baseline values (benchmark) that will allow assessing 
the effectiveness of the planned CMD revision. This seems reasonable considering that due to 
the long latency periods to develop cancer (10 to 50 years), it will not be possible to measure the 
real impact of the revision before 15-20 years. 
Availability of exposure data is presently the subject of a contract study ('HazChem@Work').130 
It  will  in  due  course  also  contribute  to  the  definition  of  the  benchmark  and  may  enable  some 
further  conclusions  to  be  drawn  about  the  effectiveness  of  the  proposed  measure.  For  the 
foreseeable future, however, the latency of some occupational cancers and other well-explained 
difficulties in collecting and aggregating exposure data between member states will continue to 
present significant challenges to their use as indicators. 

In that context aggregating exposure data collected from Member State labour inspectorates at 
EU level could have several important benefits for operation of chemicals policy – but would be 
a  very  significant  additional  burden  on  both  national  labour  inspectorates  and  possibly 
employers.    It  is  also  unlikely  that  such  data  could  in  any  case  be  effectively  aggregated  as 
reporting  structures  within  companies  and  between  sectors  and  Member  States  are  unlikely  to 
align. 

130 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. 

86 

 
 
                                                 
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 in a meeting on 17 February 2016. The 
RSB required a number of improvements.  

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

RSB main recommendations  
(1) Context of the initiative and links with the 
evaluation.  

further present the heterogeneous landscape in 
Europe;  

more  thoroughly  explain  the  procedure  to 
update  OELs  and  measures  taken  to  further 
streamline it;  
make links with the OSH evaluation findings.  

Changes done to the IA 

Further  information  on  the  situation  across  the  EU 
(e.g. ranges of existing national OELs, Member States 
most  affected)  provided  for  each  of  the  chemical 
agents in Section 5 (sections 5.1-5.13) and in Annex 9. 

The OEL setting process, as well as the steps taken to 
facilitate swifter future updates, is explained in greater 
detail in section 4.3. 

The  new  section  2.4.focuses  on  the  links  with  the 
OSH evaluation. 

the  added  value  of 

(2)  Need  to  act  and  EU  added  value  of  the 
initiative.  
further  substantiate  why  diverging  national 
OELs  are  inefficient  and  why  action  is 
required at EU level; 
further  substantiate 
providing legal clarity; 
better  explain 
interest  of  different 
stakeholders  (including  employers)  in  setting 
EU standards;  
weigh  the  overall  benefits  of  the  initiative 
(possibly including health gains related to the 
prevention  of  diseases  other  than  cancer  and 
results  of  enhanced  clarity  for  businesses) 
against its total costs. 

the 

in  order 

Sections  1.1.3,  1.3.,  2.2.  have  been  considerably 
the 
developed 
inefficiency  of  diverging  national  OELs,  the  added 
value  of  greater  legal  clarity  and  the  interests  of 
different stakeholders. 

to  better  demonstrate 

A  summary  table  has  been  introduced  under  section 
5.14,  weighing  the  retained  option  for  each  of  the 
chemical agents against a number of criteria, including 
compliance costs and health benefits. 

Additional  data  under 
section  6.1.  provides 
quantitative estimates of   the health benefits related to 
and 
such 
diseases, 
occupational skin diseases. 

occupational 

asthma 

as 

(3) Impacts on and views of stakeholders.  
more  systematically  present  the  views  of 
different  stakeholders  and 
the  expected 
impacts  on  particular  groups  (incl.  SMEs), 
distinguishing when relevant between MS and 
between specific substances.  
views  on  the  importance  of  burden  reduction 
and  simplification  of  the  OSH  legislation  in 

Further  information,  where  available,  included  for 
each of the chemical agents in Chapter 5 (sections 5.1-
5.13). 

New section 2.4. deals with the issue of simplification. 
Further discussion on burden reduction is included in 
the conclusions (sections 6.2.1. and 6.3). 

87 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
for  discarding 

them  should  be 

general should be addressed.  
(4) Alternative options.  
better  explain  why  a  broader  range  of 
approaches,  including  non-legislative  ones, 
were not considered or were discarded;  
reasons 
summarised;  
assess  in  more  details  the  feasibility  and 
consequences  of  covering 
the  chemicals 
included in this initiative through REACH.  
Procedure and presentation.  
further explain the limitations of the data used 
and their potential effect on the quantification 
of impacts.  
Whenever  relevant,  a  sensitivity  analysis 
should be applied. 

A  new  section  (4.2)  presents  a  broader  range  of 
alternative  approaches  (including  non-legislative  and 
REACH) and the reasons for discarding them. 

Further  explanations  on  methodology,  assumptions 
and  data  limitations  is  provided  in  the  introductory 
part of Chapter 5 as well as per chemical agent, where 
available, in sections 5.1-5.13.  

A  sensitivity  analysis  regarding  the  discount  rate  has 
been  conducted  and  confirmed  that  benefits  were  far 
more  sensitive  to  discounting  than  costs.  Costs  and 
benefits  have  been  recalculated  using  a  declining 
discount  rate  instead  of  the  originally  used  fix  4% 
discount  rate.  The  analysis  also  further  clarifies  what 
compliance costs would need to be incurred under the 
baseline  scenario  and  under  each  of  the  options  for 
action.  

The RSB issued a positive opinion on 1 April 2016 and several further adjustments were made 
in the text of the report following RSB's further suggestions, as summarised in the table below. 

RSB main recommendations  
(1) Costs  

Changes done to the IA 

Costs  presented  in  the  report  should  only  be 
those  incurred  compared  to  the  baseline,  i.e. 
resulting  from  the  obligation  to  respect  the 
OEL  proposed  through  a  binding  measure  in 
the  near  future  compared  to  reaching  it  later 
through 
in 
exposure. 

linear  decrease 

the  "natural" 

(2) Value added at EU level  

Need  to  extend  the  range  of  considered 
options. In particular, in order to provide legal 
certainty by industry, there could be the need 
to  set  OELs  by  industry  or  use  of  a  specific 
product.  As 
to  become  very 
burdensome  for  the  regulators,  an  alternative 
option  could  be 
scientific 
information  by  industry  and  use,  without 
setting OELs. 
(3) Stakeholders support 

to  provide 

this  risks 

The  report  should  further  expand  on  the 
the 
perception  of  stakeholders  regarding 

Sections 5.1-5.13 have been revised accordingly. 

Two  additional  options  have  been  added  in  section 
4.2. 

Further explanation on EU added value have been 
added in section 1.1.3 

IA 

The 
includes  already  opinions  of 
stakeholders  relevant  for  each  substance  in  sections 

report 

88 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
establishment  of  OELs  at  European  level  for 
specific  substances  as  opposed  to  national 
level.  This 
important  as 
is  especially 
stakeholder  support  seems  to  be  inversely 
proportionate  to  the  size  of  the  problem  (and 
potential health benefits – Table 36, p.80). 

 (4) OSH vs. REACH 

5.1-5.13 of the report.  

Further  clarification  has  been  provided  in  the  section 
5.14. 

table  comparing 

the  OSH 
Introduce  a 
framework 
possible 
instruments  to  reduce  EU  workers'  exposure 
to carcinogens. 

and  REACH 

as 

A table has been added in section 14.2.3. 

(5) Presentation 

the  estimation  of  100,000 
through 

lives 
Finally, 
potentially  saved 
the  proposed 
measures  (pp.7,  87)  should  be  more  clearly 
explained and substantiated  

The  information  requested  is  reflected  in  changes 
made in the introduction, and in section 6.5. 

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 
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".131 

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. 

131 http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf  

89 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
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/EC132 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. 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 necessary 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 for in Annex 5 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 

Following  the  two  stage  consultation  of  the  European  social  partners  (see  section  9.1  of  this 
document), DG EMPL/F/4 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  expected  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 run 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 internet.133. 

132 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)  

133 The following links are only provided for those chemical agents subject to the first amendment of the CMD: 

- Executive summary report 
- Summary report 
- 1,2-Epoxypropane 
- 1,3-Butadiene 

90 

 
                                                 
8.4.3  Study on chemical agents toxic to reproduction 

DG EMPL/F/4 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 are 
considered as chemical agents of very high concern (SVHC), meaning that they might become 
subject to the so-called authorisation procedure, which in a nutshell foresees that they cannot be 
placed on the market of the EU unless the supplier demonstrates in a dossier that the use of the 
chemical agent is safe. 

However, based on the current scientific knowledge, the majority of these chemical agents have 
a threshold below which a safe use of the chemical agent is possible. Therefore, it can be argued 
that the protection of workers is already covered under the CAD, and that Indicative OELVs or 
OELs for these  chemical  agents should  be established  under the CAD, and the more stringent 
protective and preventive measures under the CMD, in particular with regard to the substitution 
provision, are not proportionate. 

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. 

However,  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. 

- 2 Nitropropane 
- Acrylamide - Bromoethylene 
- Chromium VI 
- Ethylene oxide 
- Hydrazine 
- o-Toluidine 
- Refractory Ceramic Fibres 
- Respirable Crystalline Silica 
- Hardwood dust 
- Vinyl chloride monomer 

91 

 
 
 
                                                                                                                                                            
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, ex Article 138 of the EC Treaty). 

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 
(former Article 138(2) of the EC Treaty), 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  consultation134  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.135 

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. 

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 

134 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) 

135 CISNET EMPL 8676 of 15 June 2006 

92 

 
                                                 
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.  

93 

 
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 8.4.2). The 
results  of  the  study  as  well  as  SCOEL  recommendations,  where  available,  were  subsequently 
discussed  by  the  tripartite  ACSH  (see  point  9.2.3).  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 
risk 
(quantitative/semiquantitative) or stochastic (case by case)? 

approach 

address 

the 

the 

to 

levels 

be 

systematic 

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)136 

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 

136https://osha.europa.eu/sites/default/files/publications/documents/en/publications/reports/548OELs/survey_OELs_

CMR_substances_web_def.pdf 

94 

 
 
                                                 
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 States137. 

With regard to the current initiative it is worth noting that the chemical agents covered by this 
initiative  are  in  most  cases  also  included  in  national  OEL  lists  for  carcinogens  and  mutagens. 
The  majority  of  the  MS  which  reported  back  have  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) have 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 are 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  appear  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 6. 

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  discussed138,  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  2011139,  2012140  and  2013141,  resulting  in  one 

137 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 

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

October 2010;  

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

October 2011 

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

November 2012 

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

October 2013 

95 

 
                                                 
opinion  and  two  supplementary  opinions  adopted  by  the  plenary  of  the  ACSH  in  2012142  and 
2013143, 144. 

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 the International Agency for Research on Cancer (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  workshop145  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 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 base-line 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. 

142 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) 
143 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) 

144 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) 

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

carcinogens-and-work-related-cancer 

96 

 
                                                 
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, as well. 

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. 

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. 

In  particular  with  regard  to  RCS,  the  Commission  discussed  intensively  possibilities  to 
recognise on the one hand the results of the NEPSi Agreement, and on the other hand to protect 
also workers currently not covered by the agreement. 

The  Commission  also  participated  in  meetings  organised  annually  by  DG  GROW  with  the 
European Glass and Ceramic Industry, where similar information were presented. 

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

For silica, the main concern for industry was the inclusion of the agent in Annex I of the CMD 
but  not  the  limit  value  itself,  which  is  attainable  in  view  of  the  current  available  technologies 
and  working  methods.  It  was  argued  that  the  inclusion  of  the  agent  under  the  scope  of  the 
Directive would put a more stringent obligation on substitution and process enclosure, leading to 
non-affordable costs. It should however be noted that, where no workers were present (e.g. long 
distance  material  conveyers),  closed  processes  is  not  a  CMD  requirement  –  and  that  the 
substitution principle already applies by means of the Chemical Agents Directive. 

On Refractory Ceramic Fibres, the industry expressed their positive view on the establishment 
of an EU-wide binding OEL as a way to demonstrate appropriate control of the exposure at the 
workplace  –  potentially  of  value  in  discussions  regarding  REACH  authorisation.  The  same 
argument has been presented by the European metals industry as regards Hexavalent Chromium 
compounds. 

97 

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

Who is affected 

National authorities  

Employers 

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  (eg.,  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. 

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., 
local  exhaust  ventilation,  closed  systems,  personal 
substitution, 
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 
to  competent 
the 
authorities, etc).   

legislation,  collection  of  records, 

information 

98 

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

The  benefits  for  employers  include,  inter  alia,  avoided  loss  of 
productivity,  simplification  in  ensuring  legal  compliance,  improved 
level playing field across the EU. 

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  also  the  duty  to  comply  with  the 
dispositions provided by the employers as regards the use of preventive 
and protective measures necessary to comply with OSH legislation (.eg., 
the newly established OELs). 

99 

 
 
 
11  ANNEX 4 – 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. 

11.1  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: 

Figure 1 

Exposure  prevalence  data  were  available  from  the  Carcinogens  Exposure  database  (CAREX), 
for  almost  all  agents  analysed  in  this  impact  assessment,  except  1,2-Epoxypropane,  2-
Nitropropane and Hardwood Dust. For wood dust exposure, information on the prevalence (and 
level) of exposure was available for 25 countries following an EU project estimating the risk of 
exposure to wood dust (Kauppinen et al, 2005). For the remaining agents information collected 
from trade associations and other stakeholders was used. 

146 SHEcan report "Valuing health benefits" 
147 The  methodology  was  developed  under  the  coordination  of  the  Institute  of  Occupational  Medecine  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. 

100 

 
 
 
                                                 
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; 

-  The Woodex database (hardwood dust); 
- 

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). 

11.2  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. 

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 

101 

 
 
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. 

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 

148 (ECHA 2008) – Applying SEA as part of restriction proposals under REACH 

102 

 
                                                 
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. 

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%, have 
been recalculated applying a declining discount rate (4% for the first 20 years, 3% thereafter) in 
line with the most recent EC Better Regulation guidelines152. 

149 Data on disease specific deaths by age were not available so age weighting factors were not used.  
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.   

103 

yearsnowdeathmax(Average life expectancy)1.00degree of disabilityYLLFull health 
 
 
  
 
                                                 
  
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. 

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 

153 http://www.cdc.gov/owcd/eet/Cost/3.html#costofillness 
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. 

104 

 
 
 
 
                                                 
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-
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. 

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) 

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   

105 

 
 
 
 
 
 
 
 
                                                 
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. 
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. 

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  4.  may  differ  in  existing  literature,  but  the 
increased segregation allows us to better assign time that may be spent in each cancer stage. 

157 Morris  et.al  (2005)  -  "cost  of  skin  cancer  in  England"  -  Report  by  S.  Morris,  B.  Cox  and  N.  Bosanquet  for 
- 

Imperial 

College 

London 

School, 

Tanker 
http://www3.imperial.ac.uk/pls/portallive/docs/1/43013.PDF  

Business 

158 O'Dea  (2009)  -  "The  estimated  costs  -  economic  and  human  -  of  skin  cancers  in  New  Zealand"  - 

http://www.niwa.co.nz/?a=103433 

106 

 
 
 
 
 
                                                 
Figure 4. Cancer stages 

The  SHEcan  health  impact  assessment  has  estimated  the duration  of  time  spent  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) 
(3) 
(4) 

Lost wages160; 
Medical expenses; 
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).  As shown in Table 3. 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. 

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 

107 

Registered with cancerDiagnosis and primary therapyState after intentionally curative primary therapySurvivor with long term sequelaeCureIn remissionDisseminated / metastasis stageTerminal stageDeath (premature) 
 
 
                                                 
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). 

108 

 
 
 
 
11.3  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. 

109 

 
 
 
12  ANNEX  5  –  DETAILED  INFORMATION  ON  THE  CARCINOGENICITY  OF  THE  CHEMICAL 

AGENTS  

The  table  below  summarises  the  current  situation  as  regards  the  availability  of  SCOEL 
Recommendations for the 13 chemical agents in question. 

Table 1. Current situation regarding SCOEL Recommendations for chemical agents in the present proposal. 

Chemical Agent 

CLP 
Harmonised 
Class. 

IARC 
Class. 

SCOEL 
Recommendation 

Year  Comments 

1B 

1B 
1B 

Respirable crystalline silica N/A 
Refractory ceramic fibres 
(RCF) 
Acrylamide 
Vinyl chloride monomer 
(VCM) 
Hardwood dust, as 
inhalable dust 
Chrome (VI) compounds 
1,3 Butadiene 
Ethylene oxide 
1,2 Epoxypropane 
o-Toluidine 

1B 
1A 
1B 
1B 
1B 

N/A  

1 
2B 

2A 
1 

1 

1 
1 
1 
2B 
1 

SCOEL SUM 94  2003 
SCOEL SUM 165  2011 

SCOEL SUM 139  2010 
SCOEL SUM 109  2004 

SCOEL SUM 102  2003 

SCOEL SUM 86  2004 
SCOEL SUM 75  2007 
SCOEL SUM 160  2012 
SCOEL SUM 161  2010 
No SCOEL 
Recommendation 

2 Nitropropane 

1B 

2B 

No SCOEL 
Recommendation 

Bromoethylene 
Hydrazine 

1B 
1B 

2A 
2B 

SCOEL SUM 155  2008 
SCOEL SUM 164  2010 

12.1  Respirable crystalline silica 

12.1.1  Identification 

Index Number: 
EC Number: 
CAS Number: 

none 
none 
14808-60-7 (Quartz) 
14464-46-1 (cristobalite) 
15468-32-3 (tridymite) 

IOM Study considered potential 
OELs of 0.1 ppm (0.4 mg/m3) 
and 1 ppm  (4.4 mg/m3) as 
'typical' values of existing 
national OELs in the EU. 
IOM Study considered 0.5 ppm 
(19 mg/m3)  for assessment, as 
'typical' values for existing 
national OELs in the EU. 

Silica  (silicon  dioxide  (SiO2)),  occurs  in  either  a  crystalline  or  non-crystalline  (amorphous) 
form. Crystalline silica may be found in more than one form (polymorphism), depending on the 
orientation and position of the tetrahedra (i.e., the three-dimensional basic unit of all forms of 
crystalline silica). The natural crystalline forms of silica are α-quartz, α-,β1-, and β2-tridymite, α- 
and β-cristobalite, coesite, stishovite, and moganite (IARC, 1997). The most common form of 
naturally  occurring  crystalline  silica  are  quartz  (CAS  No.  14808-60-7),  Cristobalite  (CAS  No. 
14464-46-1) and tridymite (CAS No. 15468-32-3), but they can also be created during industrial 
processes,  such  as  the  calcination  of  diatomaceous  earth,  ceramics  manufacturing,  foundry 
processes,  silicon  carbide  manufacturing,  and  any  other  process  in  which  quartz  is  heated  to 
high temperature. 

12.1.2  Synonyms 

silicon dioxide, crystalline 

110 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12.1.3  Classification  according 
carcinogenicity161: 

None. 

to  Regulation 

(EC)  N°  1272/2008  with  regard 

to 

It should be noted that the polymorphs' of silica which comprise RCS are commonly placed on 
the market and are subject to CLP classification. 

The three most common 'polymorphs' of crystalline silica are quartz, cristobalite, and tridymite 
– all of which have been self-classified by suppliers in the EU. These classifications have been 
notified  to  the  European  Chemicals  Agency  for  inclusion  in  the  Classification  and  Labelling 
Inventory (CLI). 

Self-classifiers are not bound to adopt any particular classifications and are free to classify their 
products  differently  from  one  another.  CLI  entries  for  quartz  and  cristobalite  include  some 
classifications  for  category  1  carcinogenicity  although  the  majority  of  the  notifications  only 
concerns  Specific  Target  Organ  Toxicity  (STOT)  and  according  to  some  notifications  the 
substance  is  not  classified.  CLI  entries  for  tridymite  do  not  include  classifications  for 
carcinogenicity.  The substance has not been classified as hazardous according to CLP. 
12.1.4  Classification according to IARC162 

The International Agency for Research on Cancer (IARC) has stated its opinion that 'crystalline 
silica inhaled in the form of quartz or cristobalite from occupational sources is carcinogenic to 
humans (Group 1)' (IARC Monograph 68). 

In making its overall evaluation the IARC Working Group noted that carcinogenicity in humans 
was  not  detected  in  all  industrial  circumstances  studied,  and  that  carcinogenicity  may  be 
dependent on inherent characteristics of the crystalline silica, or on external factors affecting its 
biological activity or distribution of its polymorphs. 

There  is  more  recent  information  on  the  carcinogenicity  of  RCS  in  the  IARC  monograph 
volume 100C on arsenic, metals, fibres and dusts. This was published in 2012 and represents the 
views and expert opinions of the IARC Working Group on the Evaluation of Carcinogenic Risks 
to Humans which met in Lyon, 17 – 24 March 2009. The conclusions of the IARC Monograph 
100C  confirm,  based  on  more  recent  scientific  evidence,  that  crystalline  silica  in  the  form  of 
quartz or cristobalite dust is carcinogenic to humans (Group 1). 
12.1.5  Recommendation of SCOEL163 

The  main  effect  in  human  of  the  inhalation  of  respirable  silica  dust  is  silicosis.  There  is 
sufficient information to conclude that the relative lung cancer risk is increased in persons with 
silicosis  (and, apparently, not  in  employees  without  silicosis exposed to  silica dust in  quarries 
and  in  the  ceramic  industry).  Therefore,  preventing  the  onset  of  silicosis  will  also  reduce  the 
cancer risk. Since a clear threshold for silicosis development cannot be identified, any reduction 
of exposure will reduce the risk of silicosis. 

It  was  observed  that  the  dose-response  curve  for  silicosis  appears  to  be  sigmoidal  and  that 
maintenance of exposure below 0.05 mg/m3 would avoid being on the steeper part of the dose-

161 The majority of the chemical agents subject to this initiative are not only classified as carcinogens but also for 
other adverse health effect. Because the other effects are of less importance for the initiative as such, additional 
classifications for other adverse health effects are not mentioned here 

162 http://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-14.pdf  and 

http://monographs.iarc.fr/ENG/Monographs/vol1-42/mono42.pdf  and 
http://monographs.iarc.fr/ENG/Monographs/vol68/mono68-6.pdf 

163 Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for  Silica,  Crystalline 

(respirable dust); SCOEL/SUM/94, November 2003 

111 

 
                                                 
response  curve,  in  the  region  where  relatively  small  increases  in  exposure  entail  significant 
increases in silicosis risk. 
The  reduction  of  exposure  to  0.05  mg/m3  of  crystalline  silica  is  expected  to  reduce  the 
prevalence of silicosis, ILO category 1/1, to about or less than 5% whereas an average respirable 
silica concentration of 0.02 mg/m3
It arises that an OEL should lie below 0.05 mg/m3

 reduces prevalence of silicosis to about 0.25 % or less. 

 of respirable silica dust. 

No STEL or skin notation are needed. 

12.2  Refractory ceramic fibres (RCFs) 

12.2.1  Identification 
Index Number164: 
EC Number165: 
CAS Number166: 

12.2.2  Synonyms 

650-017-00-8 
- 
142844-00-6 

The  complete  name  of  the  chemical  agent  classified  according  to  the  CLP  Regulation  is 
"Refractory  ceramic  fibres  with  the  exception  of  those  species  elsewhere  in  Annex  VI  to 
Regulation  (EC) 1272/2008 [Man-made vitreous (silicate) fibres with  random orientation with 
alkaline oxide and alkali earth oxide (Na  2 O+K  2 O+CaO+ MgO+BaO) content less or equal to 
18 % by weight] 

Vitreous siliceous fibres, alumino-silicate glass wools 

12.2.3  Classification  according 
carcinogenicity 

to  Regulation 

(EC)  N°  1272/2008  with  regard 

to 

Carc. 1B – Causes Cancer by Inhalation 

164 Entries  in  Part  3  of  Regulation  (EC)  N°  1272/2008  of  the  Regulation  of  the  European  Parliament  and  of  the 
Council on the classification, labelling and packaging of chemical agents and mixtures are listed according to the 
atomic  number  of  the  element  most  characteristic  of  the  properties  of  the  chemical  agent.  Organic  chemical 
agents, because of their variety, have been placed in classes. The Index number for each chemical agent is in the 
form  of  a  digit  sequence  of  the  type  ABC-RST-VW-Y.  ABC  corresponds  to  the  atomic  number  of  the  most 
characteristic element or the most characteristic organic group in the molecule. RST is the consecutive number 
of the chemical agent in the series ABC. VW denotes the form in which the chemical agent is produced or placed 
on  the  market.  Y  is  the  check-digit  calculated  in  accordance  with  the  10-digit  ISBN  method.  This  number  is 
indicated in the column entitled "Index No". 

165 The EC number, i.e. EINECS, ELINCS or NLP, is the official number of the chemical agent within the European 
Union. The EINECS number can be obtained from the European Inventory of Existing Commercial Chemical 
Chemical  agent  (EINECS)[1].  The  ELINCS  number  can  be  obtained  from  the  European  List  of  Notified 
Chemical agents (as amended) (EUR 22543 EN, Office for Official Publications of the European Communities, 
2006, ISSN 1018-5593). The NLP number can be obtained from the list of 'no-longer polymers' (as amended) 
(Document, Office for Official Publications of the European Communities, 1997, ISBN 92-827-8995-0). The EC 
number  is  a  seven-digit  system  of  the  type  XXX-XXX-X  which  starts  at  200-001-8  (EINECS),  at  400-010-9 
(ELINCS) and at 500-001-0 (NLP). This number is indicated in the column entitled 'EC No'. 

166 The  Chemical  Abstracts  Service  (CAS)  provides  a  system  whereby  chemical  agents  are  added  to  the  CAS 
Registry  and  are  assigned  a  unique  CAS  Registry  Number.  Those  CAS  numbers  are  used  in  reference  works, 
databases, and regulatory compliance documents throughout the world to identify chemical agents without the 
ambiguity of chemical nomenclature  

112 

 
 
                                                 
12.2.4  Classification according to IARC167 

Group 2B – The agent is possibly carcinogenic to humans 
12.2.5  Recommendation of SCOEL168 

Occupational exposure to RCFs is associated with adverse respiratory effects as well as skin and 
eye irritation and may pose a carcinogenic risk based on the results of chronic animal inhalation 
studies. In these studies, exposure to RCFs produced an increased incidence of mesotheliomas 
in hamsters and lung cancer in rats. Mesotheliomas and sarcomas in rats and hamsters have also 
been  induced  after  intrapleural  and  intraperitoneal  implantation  of  RCFs.  Intratracheal 
instillation induced lung tumours in rats. 

Epidemiologic  studies  have  found  no  association  between  occupational  exposure  to  airborne 
RCFs and an excess rate of pulmonary fibrosis or lung cancer. 

The epidemiological studies in the US and in Europe showed an association between exposure 
and increased prevalence of respiratory symptoms and conditions such as dyspnoea, wheezing, 
chronic  cough,  decreases  in  pulmonary  function,  and  skin,  eye,  and  upper  respiratory  tract 
irritation. These findings, which primarily reflect workers employed before 1980, did not persist 
with  analysis  of  follow-up  production  years  and  accumulated  RCF  exposure  from  initial 
pulmonary  function  tests.  More  recent  exposures  from  the  late  1980s  until  2004  had  no 
deleterious impact on the longitudinal trend of FVC169 and FEV1170. During this time the RCF 
workplace  concentrations  constantly  decreased  below  1  f/ml.  Since  about  1993 
the 
concentrations ranged around 0.2 f/ml in RCF fibre manufacture facilities and decreased from 
about 0.4 to 0.3 f/ml in customer facilities171. So far none of these studies provide information at 
what  concentration  the  pulmonary  effects  are  no  longer  seen.  The  common  presence  of  other 
non-fibrous  dust  further  complicates  the  evaluation  of  effects  and  their  dose-responses  at 
specific  RCF  workplace  exposures. However,  the  studies  indicate  that the  exposures  since  the 
late 1980s neither had deleterious impact on the lung function, nor diagnosed pleural plaques or 
mesothelioma.  These  exposures  ranged  from  approximately  1  fibre/ml  to  below  the  limit  of 
detection (Rice et al 1997)172. 

Pulmonary function provides sensitive parameters to evaluate the effects of RCF exposure (see 
studies in workers in the US: Lockey et al., 1998, 2002; LeMasters et al., 1998; McKay 2010). 
The  first  cross-sectional  pulmonary  function  study  reported  statistically  (but  not  clinically) 
significant  decrements  in  FVC  and  FEV1  for  workers  in  the  highest  exposure  category  (>  60 
fibres-months per cc) compared to those in the lowest exposure category (≤15 f-m/cc), but later 
studies  reported  no  significant  decline  in  lung  function  in  a  longitudinal  analysis  of  male 
workers providing pulmonary function tests over seven years. 

Upon  request  the  authors  of  the  McKay  et  al.  (2010)  study  provided  the  following  additional 
information: 

167 http://monographs.iarc.fr/ENG/Monographs/vol81/mono81.pdf and 
http://monographs.iarc.fr/ENG/Publications/techrep42/TR42-6.pdf 

168 Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for  Refractory  Ceramic 

Fibres SCOEL/SUM/165 September 2011 

169 Force Vital Capacity is the total amount of air exhaled during the FEV test. 
170 Forced expiratory volume measures how much air a person can exhale during a forced breath. The amount of air 
exhaled  may  be  measured during  the first (FEV1),  second (FEV2),  and/or  third  seconds (FEV3) of  the  forced 
breath. 

171 A figure illustrating this trend can be found in the above mentioned  SCOEL document on page 14 
172 Rice  D,  Lockey  J,  Lemasters  G,  Levin  L,  Staley  P,  Hansen  KR  (1997)  Estimation  of  historical  and  current 
employee  exposure  to  refractory  ceramic  fibers  during  manufacturing  and  related  operations.  Appl  Occup 
Environ Hyg 12, 54-61 

113 

 
                                                 
• The average cumulative exposure among all workers in the > 60 f-mo/ml group was 147.9 f-
mo/ml, and 

•  When  sorted  by  chronological  age,  those  workers  at  age  60  in  the  >  60  f-mo/ml  group 
experienced an average cumulative exposure of 184.8 f-mo/ml. 

Assuming a 45 years exposure the average cumulative exposures of 147.9 and 184.8 f-mo/ml, 
respectively, result in an average fibre concentrations of 0.27 and 0.34 f/ml. Considering these 
values as no observed adverse effect levels SCOEL proposes an OEL of 0.3 f/ml.  

From  the  available  information  it  is  concluded  that  the  genotoxic  effects  observed  in  the 
different  studies  are  secondary  so  that  RCFs  are  classified  as  SCOEL  Carcinogen  group  C 
carcinogens: Genotoxic carcinogens for which a practical threshold is supported. 

12.3  Acrylamide 

12.3.1  Identification 

Index Number:  616-003-00-0 
EC Number: 
CAS Number: 

201-173-7 
79-06-1 

12.3.2  Synonyms 

2-propenamide, acryl acid amide, ethylene caroxamide, propenoic acid amide, vinyl amide 

12.3.3  Classification  according 
carcinogenicity: 

to  Regulation 

(EC)  N°  1272/2008  with  regard 

to 

Carc. 1B – may cause cancer 
12.3.4  Classification according to IARC173 

Group 2 A – The agent is probably carcinogenic to humans 
12.3.5  Recommendation of SCOEL174 

As  evidenced  in  animal  experiments,  acrylamide  possesses  a  number  of  hazardous  properties 
including neurotoxicity, impairment of male fertility, somatic and germ cell mutagenicity, and 
carcinogenicity. In relation to neurotoxicity, acrylamide causes impairment of axonal transport, 
leading to axonal swelling, loss of axons, degenerating myelin and changes to glial cells in the 
brain, spinal cord and peripheral nervous system. In workers, exposures to acrylamide have led 
to  clinical  signs  of  neurotoxicity  such  as  tremor,  in-coordination  and  reductions  in  nerve 
conduction velocity, and symptoms such as tingling and numbness in the hands and feet. 

There are reports of skin irritation with  an  unusual presentation, i.e  peeling  of the skin  on the 
hands and feet. 

Rodent  carcinogenicity  studies  in  which  acrylamide  was  administered  in  the  drinking  water 
showed  increased  tumour  incidences  in  a  number  of  organs/tissues  including  the  testicular 
mesothelium,  adrenals,  mammary  glands,  and  thyroid.  This  tumour  profile  suggests  that  the 
mechanism  of  carcinogenesis  may  involve  hormonal  disturbance  but  there  is  no  definitive 
evidence  for  endocrine  disturbance  that  could  account  for  the  diverse  range  of  tumours  seen. 
The fact that acrylamide does not affect fertility in females does not add support to a proposed 
hormonal mechanism for tumour development. It is also noted that there is evidence suggestive 

173 http://monographs.iarc.fr/ENG/Monographs/vol60/mono60-16.pdf 
174 Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for  Acrylamide, 

SCOEL/SUM/139, September 2011, Annex December 2012 

114 

 
 
                                                 
of  an  increase  in  glial  cell  tumours  in  the  brain  and  spinal  cord.  In  view  of  the  genotoxic 
properties of acrylamide, a role for genotoxicity cannot be excluded. 

In  relation  to  the  evidence  for  carcinogenicity  in  humans,  there  are  two  cohort  studies  in 
workers, and a number of studies of dietary exposure in the general population. None of these 
studies reveal any link between acrylamide and cancer, but there are possible limitations in these 
studies  (low  cumulative  exposures  in  the  occupational  studies  and  the  possibility  of  exposure 
misclassification  in  the  dietary  studies).  Overall,  in  view  of  the  animal  evidence  for 
carcinogenicity, as well as the evidence for somatic and germ cell mutagenicity, there has to be 
a  concern  for  carcinogenic  potential  in  humans  and  concern  for  the  possibility  of  heritable 
mutations. A clear threshold for such effects cannot be identified. The very clearcut and strong 
neurotoxicty  of  acrylamide  has  led  to  an  avoidance  of  higher  exposures  in  industrial  practice 
also  in  the  past.  Therefore,  it  is  plausible  why  no  direct  evidence  for  acrylamide  in  exposed 
humans has been obtained. 

The  uncertainties  surrounding  the  risk  of  cancer  and  genotoxicity  (in  particular  heritable 
mutations)  in  workers  exposed  to  acrylamide  suggest  that  a  health-based  OEL  cannot  be 
derived. Although attempts have been published to explain the modes of action of the various 
tumour  types  observed  in  experimental  animals  (Shipp  et  al.  2006),  the  multiplicity  of  target 
sites, combined with the directly genotoxic nature of the metabolic intermediate, glycidamide, 
add  significant  uncertainties  to  these  explanations  (see  also  the  detailed  discussion  by  DFG 
2007,  2009).  Considering  this  situation,  acrylamide  is  categorized  in  the  SCOEL  carcinogen 
group B (Bolt and Huici-Montagud 2008), as a genotoxic carcinogen, for which the existence of 
a threshold cannot be sufficiently supported at present. In consequence, a health-based OEL and 
BLV cannot be recommended. 

A  reasonable  quantitative  cancer  risk  assessment  for  humans  is  not  feasible  for  acrylamide, 
because of two reasons: (1) Human cancer studies do not provide reliable figures as a basis of a 
risk quantitation. (2) The cancers observed in rats (testicular mesotheliomas, mammary tumours, 
glial cell tumours, thyroid tumours, adrenal phaeochromocytomas) are significantly influenced 
by  species-specific  factors,  which  make  meaningful  quantitative  extrapolations  to  humans 
almost impossible. 

However, it is important that any regulation that may be established for acrylamide should also 
be protective against the development of neurotoxicity, given that there is a wealth of evidence 
for acrylamide-induced neurotoxicity in workers. 

Experimentally,  a  minimal  effect  level  (LOAEL)  for  neurotoxicity  of  1  mg/kg  per  day  and  a 
NOAEL  at  the  next  lower  dose  of  0.2  mg/kg/day  was  established  in  a  90-day  drinking  water 
study  in  rats  (Burek  et  al  1980).  Johnson  et  al.  (1984,  1986)  repeated  this  study  as  part  of  a 
chronic  study  with  a  dose  of  0.5  mg/kg  per  day  and  found  no  effect.  Both  studies  included 
electron microscopic examinations. Hence, an established NOAEL for neurotoxicity in the rats 
is  0.5 mg/kg. This  would  correspond, for the rat (8 h respiratory volume of 0.38 m3/kg) to an 
inhalation concentration of 1.32 mg.m-3, i.e. 0.45 ppm (8-hr TWA). 

In  occupational  studies  it  is  difficult  to  establish  a  dose-response  for  neurotoxicity  due  to  the 
inability to distinguish the relative contributions of dermal and inhalation exposure. However, a 
dose-response  between  neurological  symptoms  and  acrylamide-haemoglobin  adducts  was 
reported  in  a  study  in  tunnel  workers  (Hagmar  et  al  2001).  The  workers  in  this  study  were 
mainly  exposed  to  acrylamide  via  dermal  contact.  By  using  biological  monitoring  of  the 
haemoglobin adduct of acrylamide (N-2-carbamoyl-ethyl-valine), a NOAEL for neurotoxicity of 
0.5 nmol adduct/g globin was reported with respect to neurotoxicity in occupationally exposed 
persons.  This  is  seconded  by  another  notion  that  no  symptoms  of  peripheral  neuropathy  were 
reported  in  workers  with  this  same  adduct  level  in  a  biological  monitoring  study  (Jones  et  al 

115 

 
2006).  The  adduct  level  based  on  these  studies  of  0.5  nmol/g  globin  would  correspond  to  an 
airborne exposure of about 0.1 mg.m-3 or 0.035 ppm (8-hour TWA). 

Dermal absorption is important in relation to workers under practical working conditions, and a 
‘skin’ notation is therefore warranted. Indeed, in view of the low volatility of acrylamide there is 
the possibility that the skin is the dominant exposure route. 

An  Annex  on  possibilities  for  biological  monitoring  of  occupational  exposures  to  acrylamide 
was produced by SCOEL in December 2012. 

12.4  Vinyl chloride monomer 

12.4.1  Identification 

Index Number: 
EC Number: 
CAS Number: 

602-023-00-7 
200-831-0 
75-01-4 

12.4.2  Synonyms: 

VCM, chloroethylene 

12.4.3  Classification  according 
carcinogenicity: 

to  Regulation 

(EC)  N°  1272/2008  with  regard 

to 

Carc. 1A – May cause cancer 
12.4.4  Classification according to IARC175 

Group 1 - The agent is carcinogenic to humans  
12.4.5  Conclusions of SCOEL176 

Vinyl chloride is an established carcinogen, both in humans and in experimental animals. The 
primary  target  of  its  carcinogenicity  is  the  liver,  although  there  is  clear  experimental  and 
suggestive human evidence that it also acts at extrahepatic sites. The primary, and most typical, 
liver  tumour  is  angiosarcoma  (hemangioepithelioma),  but  experimental  data  also  demonstrate 
formation of hepatocellular carcinomas. 

The  SCOEL  was  asked  to  perform  an  assessment  of  human  risk  of  carcinogenicity, related  to 
workplace conditions. As a first step, available data were reviewed, which indicated that a linear 
high dose–low dose extrapolation of tumour risk was the most appropriate way in this case. 

On this basis, the available quantitative risk assessments were reviewed, including those based 
on human epidemiological data and those based on extrapolation from animal data, by means of 
PBPK modelling. 

The  different  approaches  resulted  in  final  risk  estimates  which  were  basically  consistent  with 
one another. As a result, it was inferred from epidemiological studies that a continuous exposure 
for  working  life  (estimated  to  be  14%  of  the  total  lifetime)  to  1  ppm  vinyl  chloride  would  be 
associated with a cancer risk for hepatic angiosarcoma of about 0.3 x 10-3. 

Independent  data,  derived  from  animal  experiments  and  using  PBPK  modelling,  point  to  a 
similar order of magnitude (between 0.2 and 1.6 x 10-3), and thus confirm this approach. 

175 http://monographs.iarc.fr/ENG/Monographs/vol97/mono97-8.pdf and 

http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-31.pdf 

176 Recommendation from the Scientific Committee on Occupational exposure Limits, Risk Assessment for Vinyl 

Chloride, SCOEL/SUM/109 final, November 2004 

116 

 
 
 
                                                 
12.5  Hardwood dust 

12.5.1  Identification 

Index Number: 
EC Number: 
CAS Number: 

none 
none 
none 

12.5.2  Classification  according 
carcinogenicity: 

none 

to  Regulation 

(EC)  N°  1272/2008  with  regard 

to 

12.5.3  Synonyms 
12.5.4  Classification according to IARC177 

Group 1 - The agent is carcinogenic to humans  
12.5.5  Recommendations of SCOEL178 

Exposure  to  wood  dust  was  shown  to  be  associated  with  an  increase  of  sino-nasal  cancers, 
though  this  is  a  rare  cancer.  Impairment  of  respiratory  function  and  increased  prevalence  of 
pulmonary symptoms were also observed in humans after exposure to wood dust. 

Distinction between softwoods and hardwoods 

As  regards  the  risk  of  sino-nasal  cancer,  it  seems  that  hardwood  dusts  are  particularly 
dangerous,  as  they  are  probably  also  more  dangerous  than  softwood  dusts  with  respect  to 
adenocarcinomas. However, as has already been stressed, it is impossible at the moment for two 
essential  reasons  to  clearly  identify  the  particular  role  of  each  type  of  wood  in  the  genesis  of 
cancer: (i) too few studies have addressed this problem and (ii) both types of wood are usually 
used in most wood-related fields of activity and workers have been exposed to both of them. 

As regards the risk of non-carcinogenic effects on the respiratory tracts, practically all types 
of wood can cause various pulmonary symptoms in exposed workers, although only some, red 
cedar  in  particular,  have  been  studied  in  any  detail.  However,  the  large  number  of  studies 
involving  red  cedar  should  not  be  taken  to  imply  that  the  dust  of  this  species  is  the  only  one 
responsible  for  asthma  and  non-allergic  affections  of  pulmonary  function.  It  is  very  probable 
that similar results for respiratory effects due to the dusts of other wood species would be found 
if they had been studied in sufficient detail. This is suggested by the numerous descriptions of 
asthma cases related to occupational exposure to dust from many types of wood. 

Irrespective  of  their  already  emphasised  inadequacies,  the  results  of  experimental  studies  in 
animals  provide  no  conclusive  argument  to  justify  a  distinction  between  effects  specific  to 
softwood dusts and other effects specific to hardwood dusts. 

With regard to currently available data and with a view to protecting the health of workers, all in 
all it does not seem pertinent to distinguish between softwood and hardwood dusts. 

Particle size considerations 

In the last decade, the rationale for sampling particle sizes relevant to expected health effects has 
gained  recognition  with  the  adoption  of  health-related  aerosol  size  fraction  definitions  by  the 
International  Organization  for  Standardization  (IOS,  1991),  the  American  Conference  of 
Governmental Industrial Hygienists (ACGIH, 2000) and the Comité Européen de Normalisation 

177 http://monographs.iarc.fr/ENG/Monographs/vol62/mono62-6.pdf and 

http://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-15.pdf 

178 Recommendation from the Scientific Committee on Occupational Exposure Limits: Risk assessment for Wood 

dust, SCOEL/SUM/102 final, December 2003 

117 

 
                                                 
(CEN).  Three  particle  size  distributions  relevant  to  different  capture  areas  of  the  human 
respiratory tract are distinguished: inhalable (any particles which enter the nose and mouth; 50% 
capture  of  100  µm  aerodynamic  diameter  particles);  thoracic  (particles  which  pass  the  larynx; 
50% capture of 10 µm particles) and respirable (or alveolar: particles which enter the alveolar 
region; 50% capture of 4 µm particles). Occupational exposure standards specifically indicating 
these  dust  fractions  should  have  two  major  advantages:  reducing  the  variability  due  to 
fluctuations in the size distributions sampled and targeting the appropriate risk factors for wood 
dust-related disease. 

However, most epidemiological studies have not assessed exposure-response relationships using 
particle size-selective measurements. 

Considerable uncertainties exist to establish valid conversion ratios from total dust (as measured 
by the equipment used for most epidemiological studies), to an inhalable dust level, which is the 
most  appropriate  size  fraction  for  the  mass  effects  of  exposure  to  wood  dust.  However,  the 
available data suggest that a numerical value of an OEL expressed as "inhalable dust" may be 
set  at  approximately  twice  the  numerical  value  for  the  corresponding  limit  value  for  "total 
dust"179. 

The mechanism underlying carcinogenesis by wood dust has not yet been elucidated. The few 
positive  results  in  genotoxicity  tests  were  obtained  mainly  with  extracts  of  woods.  The 
hypothesis  of  physico-mechanical  cancer  induction  has  not  been  clearly  demonstrated  by 
experiments. 

The studies available do not provide adequate information for setting a health-based limit value 
for the protection of workers exposed to wood dust.  

Taking into account the uncertainties and limitations of the available studies, it can be stated that 
exposure  above  0.5  mg/m3  induces  pulmonary  effects  and  should  be  avoided.  Exposure  levels 
lower  than  0.5  mg/m3  were  associated  with  the  induction  of  bronchial  asthma  only  when  the 
exposure  was  to  western  red  cedar  dust.  The  level  of  0.5  mg/m3
  (total  dust)  and  1  mg/m3
(inhalable dust) is probably below the levels to which the cases of sino-nasal cancers had been 
exposed. 

12.6  Chromium (VI) compounds 

12.6.1  Identification 

Major  factors  governing  the  toxicity  of  chromium  compounds  are  oxidation  state  and 
solubility.180  Chromium (VI) compounds  – also  known as  hexavalent  chromium compounds  – 
which  are  powerful  oxidizing  agents,  appear  to  be  much  more  toxic  systemically  than 
Chromium (III) compounds given similar amounts and solubility181. 

Chromates and dichromates exist as a wide variety of compounds with 20 to 30 being of major 
industrial  importance.  These  include,  ammonium  chromate  and  dichromate,  barium  chromate, 
calcium chromate and dihydrate, chromic chromate, chromium (IV) chloride, chromium trioxide 
orange 
(chromic 

chromates,  molybdenum 

chloride, 

chromyl 

acid), 

lead 

179 Further information on this topic is provided in an Annex to  the above mentioned SCOEL document. 
180 The solubility of chromates varies widely and ranges from virtually insoluble to highly soluble. The various uses 
of the term solubility have caused much confusion and to harmonise discussions and classification it has been 
proposed  (Cross  et  al,  1997)  that  the  water  solubility  of  hexavalent  chromium  compounds  can  be  defined  as: 
poorly soluble (<1g/l), sparingly soluble (1-10g/l); highly soluble (>100g/l). Thus, poorly soluble includes lead 
and barium chromate, sparingly soluble includes strontium, calcium and zinc chromate and highly soluble would 
include sodium and potassium chromates and dichromate. 
181 http://www.atsdr.cdc.gov/csem/chromium/docs/chromium.pdf 

118 

 
 
 
                                                 
(PbCrO4PbMoO4Pb.SO4Al2O3),  potassium  chromate  and  dichromate,  sodium  chromate  and 
dichromate and zinc chromates. 

A subset of six chromium (VI) compounds are listed in Annex XIV of the REACH Regulation 
and so are, or will be, subject to 'authorisation' for continued use.  Available evidence (e.g. from 
the CAREX database) indicates that sodium, potassium, calcium and ammonium chromates and 
dichromates  have  been  identified  as  the  most  important  exposures,  a  number  of  which  are 
already regulated under REACH. 

The assessment of other chemical agents subject to REACH authorisation is deferred from this 
report.    However,  as  not  all  chromium  (VI)  compounds  are  listed  in  REACH  Annex  XIV  the 
same argument does not apply here. 

Further,  it  is  not  possible  based  on  available  data  to  identify  exposed  populations  or  impacts 
associated only with chromium (VI) compounds which are not listed on REACH Annex XIV, 
nor to account for the impact REACH authorisation may have on exposures for those important 
compounds to which it will apply. 

The  IOM  study  assessed  impacts  of  introducing  an  OEL  for  all  Chromium  VI  compounds, 
including those subject to REACH. 

While this analysis is based on best available data, it should be noted that this results in likely 
overestimates  of  both  the  costs  and  benefits  associated  with  setting  an  OEL  under  CMD  for 
Chrome (VI) compounds. 

12.6.2  Synonyms 

12.6.3  Classification  according 
carcinogenicity 

to  Regulation 

(EC)  N°  1272/2008  with  regard 

to 

Chromium (VI) compounds with the exception of barium chromate and of compounds otherwise 
specified  in  Annex  VI  to  the  CLP  Regulation  have  a  harmonised  classification  as  Carc.  1B  – 
May  cause  cancer  by  inhalation.  13  further  chromium  (VI)  compounds  have  harmonised 
classification entries as carcinogenic category 1. 
12.6.4  Classification according to IARC182 

Group 1 - The agent is carcinogenic to humans  
12.6.5  Conclusion of SCOEL183 

Non-cancer end-points: 

In humans occupationally exposed by inhalation to hexavalent chromium compounds, the main 
health effects are irritant and corrosive effects on the skin and respiratory tract. Effects on the 
respiratory  tract  include  inflammation  of  the  nasal  septum.  Lower  respiratory  effects  include 
inflammation  and  obstructive  disorders;  transient  impairment  on  lung  function  has  been 
reported. It is uncertain to what extent short-term exposure to high hexavalent chromium levels 
or direct contamination of the nasal mucosa with chromium may be involved in the development 
of the nasal lesions and this complicates a clear interpretation of the significance of the reported 
average  exposure  levels  in  relation  to  these  health  outcomes.  Renal  dysfunction  has  been 
reported  in  some  studies,  indicated  by  altered  urinary  protein  or  enzyme  levels.  In  contrast, 
some studies have reported no effects on kidney function. Irritant and corrosive effects on the GI 
tract and effects in the liver have been reported following repeated exposure, but these cannot be 

182 http://monographs.iarc.fr/ENG/Monographs/vol49/mono49-6.pdf and 

http://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-9.pdf 

183 Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits:  Risk  assessment  for 

Hexavalent Chromium; SCOEL/SUM/86; December 2004 

119 

 
                                                 
related to exposure data. Hexavalent chromium compounds are potent skin sensitisers in humans 
and  can  cause  respiratory  sensitisation,  Sensitised  individuals  may  also  react  to  trivalent 
chromium  compounds.  In  general,  the  animal  investigations  from  both  single  and  repeated 
exposures are supportive of the effects seen in humans although the data do not cover the wide 
range of hexavalent chromium compounds in common use, most focussed on the highly soluble 
compounds,  and  do  not  allow  clear  NOAELs  to  be  established  for  the  health  endpoints 
investigated. 

Carcinogenicity: 

A large number of epidemiological studies are available which have investigated cancer risks. 
Studies  of  chromate  production  workers  provide  clear  evidence  of  increased  lung  cancer 
mortality.  Excess  risk  of  lung  cancer  mortality  has  also  been  reported  for  workers  in  the 
chromate pigment industry, producing principally lead and zinc chromates. There is suggestive 
evidence  that  zinc  chromate,  rather  than  lead  chromate,  is  associated  with  the  increased  lung 
cancer mortality in the pigment producing industry. One study of chrome platers provides clear 
evidence of increased lung cancer risks and this finding is supported by other less informative 
studies of chrome platers. Epidemiological investigations of ferrochrome workers, stainless steel 
production workers  and  stainless  steel  welders have  generated  conflicting  results  and  with  the 
added complication of co-exposure to known carcinogens, allow no conclusions to be reached 
regarding  lung  cancer  risks  in  relation  to  hexavalent  chromium  exposure  in  these  industries. 
Overall, only a few of the reported epidemiological studies provide exposure data and no single 
study includes measurements of occupational exposures for all time periods under investigation. 
Consequently, any quantification of lung cancer risk is based on limited data. 

The carcinogenicity of a number of hexavalent chromium compounds has been investigated in 
animal  studies  using  various  route  of  exposure;  the  most  informative  for  the  purpose  of 
estimating  cancer  risks  to  humans  in  occupational  settings  are  inhalation,  intratracheal 
instillation  and  intrabronchial  studies.  In  an  inhalation  study,  in  which  rats  were  exposed  to 
sodium  chromate  (0.025,  0.05  or  0.1mg  Cr/m3),  increased  lung  tumours  occurred  only  at  the 
highest  dose.  In  a  mouse  inhalation  study,  increased  lung  tumours  were  associated  with 
exposure  the  calcium  chromate  at  the  concentration  used  of  (4.3mg  Cr/m3).  Two  mouse 
inhalation  studies  showed  a  nonsignificant  increase  in  lung  tumours  following  exposure  to 
chromium  (IV)  oxide.  These  inhalation  studies  all  suffered  from  some  deficiencies  in  design. 
Other  inhalation  studies,  some  of  which  investigated  less  soluble  hexavalent  chromium 
compounds,  had  major  deficiencies  that  prevented  any  conclusions  being  drawn.  In  one 
intratracheal instillation study, increased lung tumour incidence was reported in rats following 
exposure  to  calcium  chromate.  In  the  same  study,  sodium  dichromate  was  associated  with 
increased lung tumour incidence in rats with 1.25mg/kg/week (0.5mg Cr/kg/week) administered 
as one weekly dose, but not when the same weekly dose was administered in five instillations. 
Other  intratracheal instillation  studies  had  major  limitations,  which  prevented  any  conclusions 
being  drawn.  An  intrabronchial  implantation  study  in  rats  demonstrated  elevated  lung  cancer 
incidence  with  calcium  chromate,  strontium  chromate  and  zinc  chromate,  but  failed  to 
demonstrate  evidence  for  carcinogenicity  of  poorly  soluble  compounds  (lead  chromate  or 
barium chromate) or sodium dichromate, although the method may be inappropriate for highly 
soluble compounds. 

On the basis of the animal carcinogenicity data, it is concluded that there is evidence to suggest 
a  potency  difference  between  hexavalent  chromium  compounds,  probably  related  to  solubility 
and  consequently  bioavailability.  However,  the  variation  in  design  of  the  animal  studies  and, 
crucially,  the  scarcity  of  reliable  data  for  poorly  soluble  hexavalent  chromium  compounds 
precludes definite distinctions being made, either qualitative or quantitative, between hexavalent 
chromium compounds on the basis of the available animal studies done alone. 

120 

 
The genotoxicity of hexavalent chromium compounds has been widely investigated in assays for 
different genetic endpoints and has, with a few possible exceptions, been uniformly positive in 
in vitro assays for mutagenicity and clastogenicity, with evidence of in vivo expression of these 
effects  in  some  compounds.  The  possible  exceptions  are  lead  and  barium  chromate  and  these 
two compounds have required solubilisation to elicit positive results in bacterial cell assays or to 
enhance their genotoxic activity in mammalian cells. Although there appears to be a difference 
in  genotoxic  potential  between  the  various  hexavalent  chromium  compounds  tested  based  on 
solubility, positive results were obtained with the poorly soluble compounds in some assays. It 
is therefore not possible to exclude any compounds tested from possessing some mutagenic or 
clastogenic potential. 

Basis for recommending a limit: 

The  health  effects  associated  with  occupational  exposure  to  hexavalent  chromium  compounds 
are  carcinogenicity,  (specifically  lung  cancer),  sensitisation,  renal  toxicity  and  irritancy,  and 
corrosivity of the skin, respiratory and gastrointestinal tract. Clearly, the most serious of these 
outcomes in health terms is lung cancer and, given the magnitude of occupational cancer risks 
shown  in  some  of  the  earlier  epidemiological  studies,  and  given  that  hexavalent  chromium 
compounds are comprehensively genotoxic, it follows that lung cancer is the critical effect upon 
which to base any occupational exposure limit. Ideally, it would be preferable to develop lung 
cancer  risk  estimates  for  individual  hexavalent  chromium  compounds  (or  a  few  groups  of 
compounds).  Unfortunately,  the  quantity  and  quality  of  the  epidemiological  data  are  not 
sufficient  to  rank,  with  any  confidence,  the  carcinogenic  potencies  of  the  various  hexavalent 
chromium  compounds  encountered 
industry.  The  available  animal  carcinogenicity 
investigations  do  not  provide  this  missing  information.  Notwithstanding  the  dearth  of 
appropriate  human  studies,  the  available  human  and  experimental  animal  data  indicate  that 
poorly  soluble  hexavalent  chromium  compounds  have  a  lower  carcinogenic  potency  than 
soluble  compounds.  Such  an  effect  might  be  explained  be  the  relatively  lower  delivery  of 
bioavailably-active chromium ions to the intracellular target in the respiratory epithelium. 

in 

Lung cancer risk assessment: 

The study of Mancuso (1975) currently dominates the risk assessments of hexavalent chromium; 
USEPA, 1984; Gibb et al, 1986; PCHRG 1993; Crump, 1995. However, this survey, with a total 
of  41  lung  cancer  deaths  available  for  analysis,  does  not  constitute  a  large  epidemiological 
study. In addition, the job histories and exposure histories of study subjects seem to be poorly 
described. 

A risk assessment for hexavalent chromium based on epidemiological data, has been prepared 
for  the  US  Occupational  Safety  and  Health  Administration  (OSHA)  (Crump,  1995).  This 
assessment  identified  six  sets  of  epidemiological  data  that  provided  some  quantitative 
information on chromium exposures (Mancuso, 1975; Hayes  et al, 1979; Langård et al, 1980; 
Axelsson et al, 1980; Pokrovskaya & Shabynina, 1973; Sjögren et al, 1987). The risk estimates 
prepared  for  OSHA  are  that  some  6-9  excess  lung  cancer  deaths  will  be  experienced  over  a 
lifetime by a cohort of 1000 workers followed-up from the age of 20 years and occupationally 
exposed to 1μg/m3
 of hexavalent chromium until retirement at age 65 years (Crump, 1995). At 
an occupational exposure level of 50μg/m3, the predicted number of occupational lung cancers 
was in the range 246 to 342. These assessments were based on data from the Mancuso (1975). 
When the assessments were based on the cohort of Hayes et al, (1979) the corresponding figures 
were  2  excess  lung  cancer  deaths  at  an  exposure  level  of  1μg/m3  and  88  excess  lung  cancer 
deaths at an exposure level of 50μg/m3. (The 4 other studies were judged to be less suitable for 
any primary risk assessment.) 

The  study  cohort  of  chromate  production  workers  described  by  Hayes  et  al  in  1979  was 
redefined  and  updated  (Gibb  et  al,  2000).  The  new  cohort  comprised  2357  workers  first 

121 

 
employed between 1950 and 1974; follow-up was to the end of 1992. The new cohort included 
990 workers who were employed for less than 90 days. These latter workers were included to 
increase the size of the low exposure group. Short-term workers are often found to have unusual 
patterns of mortality and it is unclear whether or not the inclusion of this group has been helpful. 
The authors put considerable effort into characterising chromium exposures in different jobs and 
different time periods. Unfortunately, the resulting job-exposure matrix is not reported. What is 
clear, however, is that many estimated exposures must have been very low because 75% of the 
cohort  have  estimated  cumulative  hexavalent  chromium  exposures  in  the  range  0  - 
0.0769mg/m3/y.  A  statistically  significant  non-monotonic  positive  trend  is  shown  for  lung 
cancer  in  relation  to  four  levels  of  cumulative  hexavalent  chromium  exposure  and  the  study 
provides further evidence of excess lung cancer risks being causes by hexavalent exposure. The 
incorporation  of  the  study  findings  into  quantitative  risk  assessment  is  problematical  in  that 
three  of  the  four  exposure  categories  are  so  low  (0  –  0.00149,  0.0015  –  0.0089  and  0.0090  – 
0.0769mg  CrO3/m3/y)  A  further  follow-up  of  332  workers,  first  employed  at  a  US  chromate 
plant in the period 1931-37, has been reported by Mancuso (1997); follow-up was to the end of 
1993.  The  study  suffers  from  the  absence  of  standard  modern  methods  of  analysis  such  as 
Poisson  regression.  The  reader  is  supplied  with  much  of  the  raw  data  in  terms  of  deaths,  and 
person-years-at  risk  shown  by  eight  age-group  categories  and  seven  cumulative  chromium 
exposure categories (total, soluble and insoluble chromium exposure are shown in turn). There 
then  follows  a  descriptive  account  of  patterns  in  the  data  rather  than  a  statistical  analysis  that 
seeks  to  identify  the  independent  effects  of  different  chromium  exposures.  The  data  reported 
does  not  however,  supply  sufficient  information  to  carry  out  the  necessary  analysis. 
Interestingly, the overwhelming  majority of the Gibb  et al, 2000 study population (perhaps in 
order of 90% of the cohort) would be placed in the lowest exposure categories in the Mancuso, 
1997 study. 

Sorahan et al (1998) publishes a worked example of a quantitative risk assessment based on data 
from  a  single  cohort  study  of  chrome  platers.  These  calculations  provided  risk  estimates  that 
were higher than those shown in the Criteria Document of Cross  et al ( 1997). The difference 
arose,  in  the  main,  because  different  assumptions  were  made  about  the  exposure  conditions 
pertaining  to  the  study  cohort.  It  is  clear  that  under-or  over-estimation  of  the  exposure 
conditions which gave rise to the observed lung cancer excesses will have dramatic effects on 
any quantitative risk estimation derived from the epidemiological findings. It seems reasonable 
to use estimates which are based on more than one study, and the estimates shown in Table 4 in 
Appendix  1184  (column  1  relating  to  assumption  1)  which  are  based  on  summary 
epidemiological  findings  from  ten  published  cohort  studies  are  considered  to  involve  more 
reasonable  assumptions  about  exposure  conditions  than  do  those  predictions  shown  in  other 
columns of Table 4. 

The  preferred  risk  assessment  (see  Appendix  1)  is  thus  based  on  a  summary  of  ten  published 
studies (Steenland et al, 1996) and it has been estimated that about 5-28 excess lung cancers will 
occur in a cohort of 1000 male workers, followed-up from age 20 to age 85 and occupationally 
exposed  to  50μ/m3  of  hexavalent  chromium  until  retirement  at  age  65.  The  corresponding 
number of excess lung cancers has been estimated to be 2-14 for an exposure level of 25μg/m3, 
1-6  for  an  exposure  level  of  10μg/m3,  0.5-3  for  and  exposure  of  5μg/m3  and  0.1-0.6  for  and 
exposure level of 1ug/m3

. 

It is important to recognise that there are a number of limitations attached to all the proceeding 
estimates. They do not include statistical uncertainty and this will be considerable for the OSHA 
assessments given the small number of deaths available for that analysis. Uncertainty also exists 
regarding the appropriateness of the dose-response model employed. The model used assumes 

184 see further details in the SCOEL recommendation as such 

122 

 
                                                 
linear extrapolation of cancer risks through the origin; there is no “threshold” dose, i.e. no dose 
or  dose  rate  below  which  there  is  no  carcinogenic  effect.  This  is  particularly  important  in  the 
case  of  hexavalent  chromium,  which,  because  it  is  comprehensively  genotoxic,  could  be 
considered  an  ideal  carcinogenic  chemical  agent  to  which  to  apply  a  “no  threshold”  linear 
extrapolation.  However,  it  should  also  be  recognised  that  the  irritant  and  inflammatory 
properties of hexavalent compounds may also contribute to the carcinogenic process and that for 
these  effects  there  will  be  thresholds.  It  is  not  known  to  what  extent  irritancy  may  contribute 
towards  carcinogenicity  but  it  is  quite  plausible  that  linear  extrapolation  to  low  doses,  below 
those  seen  in  existing  studies  and  where  irritancy  does  not  occur  may  over-estimate  the  true 
cancer risk. One should also take into account the lung’s ability to reduce hexavalent chromium 
to  the  non-genotoxic  and  non-carcinogenic  trivalent  species  (De  Flora,  2000).  Unfortunately, 
epidemiological  data  can  contribute  little  to  this  important  issue.  Whilst  epidemiological  data 
may shown no excess lung cancer risk in a low cumulative exposure category, it is most likely 
that  the  confidence  intervals  attached  to  any  such  observed  estimate  of  risk  will  include  the 
(low)  projected  risk  estimate  supplied  by  linear  extrapolation  of  cancer  effects  observed  at 
higher cumulative exposures. Consequently, this aspect of model definition cannot be tested. In 
addition, other aspects of the statistical model used in the risk assessment are not based on the 
source  data  themselves.  For  example,  any  risk  modifying  effects  of  sex,  age  at  exposure  and 
period of follow-up have not been estimated. It is also of concern that the risk assessments have 
a  sizable  fraction  of  the  total  predicted  risk  occurring  at  ages  beyond  the  follow-up  ages 
available in the source data. 

The proposed risk estimate has, for reasons discussed, not drawn any distinction between highly, 
sparingly and poorly hexavalent chromium compounds. However the available evidence, albeit 
incomplete,  strongly  suggests  that  poorly  soluble  hexavalent  compounds  carry  a  lesser  lung 
cancer  risk  although  the  size  of  such  a  reduction  cannot  be  quantified.  Thus,  in  establishing 
occupational  exposure  limits  a  pragmatic  approach  may  be  appropriate.  As  an  example,  an 
exposure  limit  of  50μg/m3
  of  hexavalent  chromium  may  well  provide  adequate  protection  for 
workers exposed to poorly soluble hexavalent chromium compounds but, on the basis of the risk 
assessments described in Appendix 1, consideration could be given to setting exposure limits at 
25μg/m3

 for other hexavalent chromium compounds. 

 or 10μg/m3

12.7  1-3 Butadiene 

12.7.1  Identification 

Index Number: 
EC Number: 
CAS Number: 

601-01300-X 
203-450-8 
106-99-0 

12.7.2  Synonyms 

buta-1,3-diene, diethylene, divinyl, vinylethylene 

12.7.3  Classification  according 
carcinogenicity 

to  Regulation 

(EC)  N°  1272/2008  with  regard 

to 

Carc. 1A – may cause cancer 
12.7.4  Classification according to IARC185 

Group 1 - The agent is carcinogenic to humans  

185 http://monographs.iarc.fr/ENG/Monographs/vol97/mono97-6.pdf 

123 

 
 
                                                 
12.7.5  Recommendation of SCOEL186 

1,3  Butadiene  was  tested  adequately  for  carcinogenicity  in  mice  and  rats  by  inhalation.  In 
independent  experiments  in  mice,  tumours  were  induced  in  both  sexes,  at  multiple  sites,  at 
concentrations  ranging  from  6.25  to  1,250  ppm.  Exposure-related  increases  were  observed  for 
lung 
numerous  cancer 
alveolar/bronchiolar adenomas and carcinomas, and forestomach papillomas and carcinomas. In 
one experiment in rats, multiple-site increased tumour incidence was only seen at 8000 ppm. 

including  heart  angiosarcoma,  malignant 

lymphomas, 

types, 

The  recent  updating  of  the  follow-up  on  a  large  North-American  cohort  of  styrenebutadiene 
rubber  workers  revealed  a  greater  than  twofold  increase  in  leukaemia  mortality  among  long-
term workers, with a significant dose-response relationship to cumulative exposure to butadiene 
after adjusting for styrene and dimethyldithiocarbamate exposure; the independent effect of each 
agent could not be firmly evaluated. 

Two  smaller  cohort  studies  of  butadiene  production  workers  showed  slight  excesses  of 
lymphohaemopoietic  cancers,  but  these  were  not  considered  to  be  associated  with  butadiene 
exposure. 

On the basis of the available evidence, the SCOEL agreed that 1,3 Butadiene should be treated 
as a possible human carcinogen, operating via a genotoxic mechanism. Hence, according to the 
established approach for such carcinogenic chemical agents, the excess risk entailed in exposure 
during a working life to various concentrations of butadiene has been calculated using various 
models; the results are illustrated in the Annexed table.  

Based on the model used in the SCOEL recommendation, using the exposure estimates and their 
associated  relative  rates  reported  in  the  most  recent  epidemiological  study,  SCOEL  calculated 
the additional leukaemia risk associated with exposure to 1 ppm (proposed OEL) 1,3 Butadiene 
for a 40-year working life, as follows: 

"In a population of 1.000 adult males experiencing a mortality rate similar to that of the male 
population  of  England  and  Wales,  occupational  exposure  to  1  ppm  of  1,3  Butadiene  for  a 
working  life  (40  years  between  the  ages  of  25  and  65),  will  cause  from  0.0  to  10.78  extra 
leukaemia deaths between the ages 25-85 years, in addition to the 5 leukaemia deaths expected 
to occur in the absence of exposure to 1,3 Butadiene.” 

No STEL or “skin” notation was considered necessary. 

At the levels discussed, no measurement difficulties are anticipated. 

12.8  Ethylene oxide 

12.8.1  Identification 

Index Number: 
EC Number: 
CAS Number: 

603-023-00-X 
200-849-9 
75-21-8 

12.8.2  Synonyms 

Oxirane 

12.8.3  Classification  according 
carcinogenicity 

Carc. 1B – may cause cancer 

to  Regulation 

(EC)  N°  1272/2008  with  regard 

to 

186 Recommendation  from  the  Scientific  Opinion  on  Occupational  Exposure  Limits:  Ris  assessment  for  1,3 

Butadiene 

124 

 
 
                                                 
12.8.4  Classification according to IARC187 

Group 1 - The agent is carcinogenic to humans  
12.8.5  Conclusion of SCOEL188 

The relevant endpoint for discussion of limiting occupational exposures to ethylene oxide is its 
carcinogenicity. 

Ethylene  oxide  is  a  weak  alkylating  agent  that  is  directly  mutagenic  and  carcinogenic.  After 
external  exposure  it  is  distributed  within  the  entire  organism,  and  in  quantitative  terms  DNA 
alkylation is relatively uniform in the body. This affects in a similar way tumour target and non-
target tissues. The carcinogenicity is clearly evident from animal experiments. In rats (Fischer 
344),  ethylene  oxide  has  induced  brain  tumours,  mononuclear  cell  leukaemias  and  peritoneal 
mesotheliomas,  in  mice  (B6C3F1)  lung  adenomas  and  carcinomas.  In  long-term  experiments, 
significant  carcinogenic  effects  were  seen  upon  repeated  daily  inhalation  of  33  ppm  and  100 
ppm  ethylene  oxide.  The  carcinogenicity  of  ethylene  oxide  is  reasonably  connected  with  its 
DNA alkylating and resulting genotoxic properties. IARC (2008) has assessed ethylene oxide to 
be  carcinogenic  for  humans  (“Group  1”),  rating  the  epidemiological  evidence  itself  as  being 
limited,  but  considering  further  elements  of  mechanism/mode  of  action  and    “other  relevant 
data”. 

Peritoneal  mesotheliomas  represent  a  quantitatively  major  malignancy  induced  in  rats  by 
chemical carcinogens (e.g. acrylamide). In humans, such tumours can be induced by asbestos, 
but  not  by  such  chemicals.  There  are  no  epidemiological  indications,  whatsoever,  of  such  a 
target site for ethylene oxide-induced carcinogenesis in humans. There are, however, indications 
of  haematopoietic/lymphatic  cancer  in  humans  that  must  be  taken  seriously,  as  evaluated  by 
IARC (2008). No consistent evidence in humans could be found for brain, lung and mammary 
tumours. The available data on human haematopoietic/lymphatic cancer were therefore used as a 
starting point of published quantitative risk assessments (Kirman et al 2004, Valdez-Flores et al 
2010, 2011). 

in 

statistically  elevated  DNA  adducts, 

A  unique  feature  for  ethylene  oxide  is  that  low  levels  of  this  chemical  are  produced 
endogenously by both the human and animal organism, and ethylene oxide represents therefore 
a  physiological  body  constituent.  In  experimental  animals,  repeated  exposures  to  10  ppm 
resulted 
the  main  adduct  being  N7-(2-
hydroxethyl)guanine (HOEtG). In earlier publications, the physiological background of HOEtG 
in rats was estimated to correspond to repeated exogenous exposures at 1 ppm ethylene oxide, 
but  during  the  last  20  years  there  have  been  gradual  improvements  of  the  methods  of  adduct 
detection and quantitation (see Section 2.7). The most recent experimental study of Marsden et 
al  (2007;  see  Section  2.7),  using  LC-MS/MS,  arrived  at  the  conclusion  that  at  a  single  or 
repeated  dose  (i.p.)  to  rats  of  0.01  mg/kg  of  ethylene  oxide  any  DNA  adduct  increase  was 
negligible,  compared  to  the  endogenous  damage  already  present.  The  extent  of  DNA  damage 
was  linear  with  the  dose  applied,  and  the  damage  did  not  accumulate  with  repeated  ethylene 
oxide administration. The transpolation of these data into a human risk assessment is a matter of 
current  research,  and  more  work  into  the  underlying  mechanisms  will  be  needed  to  arrive  at 
valid risk conclusions (Swenberg et al 2011). 

One  problem  is  that  experimental  ethylene  oxide  exposures  of  rodents  lead  to  a  relatively 
uniform  distribution  of  HOEtG  adducts  in  the  DNA  of  both  target  and  nontarget  organs  for 
carcinogenicity,  another problem  is  that  promutagenic  adducts  other  than  HOEtG  are  detected 

187 http://monographs.iarc.fr/ENG/Monographs/vol97/mono97-7.pdf and 

http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-28.pdf 

188 Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for  ethylene  oxide; 

SCOEL/SUM/160; June 2012 

125 

 
                                                 
only after very high experimental exposures. Human field data of Yong  et al (2007) indicated 
that human workplace exposures within the studied range of 0.36 ± 0.31 ppm 8-h TWA did not 
lead  to  significant  elevation  of  the  HOEtG  adduct  levels  in  granulocyte  DNA  over  the 
endogenous background (see Section 2.7). This could suggest that the genotoxic risk of ethylene 
exposures at lower levels ought to be practically negligible. At higher concentrations, ethylene 
oxide exposures have led to genotoxic damage in occupationally exposed humans. Cytogenetic 
signs  of  genotoxicity  were  visible  at  exposure  levels  of  5  ppm  and  above.  At  exposures  of  1 
ppm, no genotoxic changes could be directly established in exposed humans so far (see Section 
2.6.2). 

Although  a  non-linear  dose-response  (genotoxicity)  relationship  can  reasonably  be  assumed 
based on arguments of mode of action (Kirman  et al 2004), a definite noeffect level based on 
dose-response  data  cannot  be  defined.  In  this  situation,  SCOEL  provisionally  categorises 
ethylene  oxide  into  “Group  B”  as  a  genotoxic  carcinogen,  for  which  a  threshold  is  not 
sufficiently supported (Bolt and Huici-Montagud 2008).  

This  situation  calls  for  a  quantitative  cancer  risk  assessment.  Because  of  the  argumentation 
given  above  (Section  2.8.3)  this  should  preferably  be  based  on  epidemiological  data  on 
haematological malignancies. The most recent assessment based on studies in approximately 20 
000 workers of the combined NIOSH and UCC/Dow cohorts by Valdez-Flores et al (2011) was 
considered by SCOEL as most reliable at present. The data (for males and females combined) 
are compiled in Table 1. 

There  is  a  solid  data  base  for  biological  monitoring,  based  on  HOEtVal  haemoglobin  adduct 
monitoring.  Boogaard  (2002)  has  compiled  the  argumentations  and  elements  for  establishing 
biological  limit  values  (BLV).  A  derivation  was  performed  by  Boogaard  et  al  (1999)  for 
exposure conditions of an 8-h TWA of 0.5 ppm, corresponding to a HOEtVal level of 3.2 nmol 
per g globin. In consequence, a TWA of 0.1 ppm would correspond to a biological haemoglobin 
adduct  value  of  0.64  nmol  (640  pmol)  HOEtVal/g  globin.  Other  extrapolated  figures  are 
included  in  Table  1.  The  values  given  in  Table  1  can  still  be  distinguished  from  the  general 
background value of about 20 pmol HOEtVal/g globin. 

A  skin  notation  is  warranted,  as  clear  signs  of  systemic  toxicity  were  reported  after  local 
application of ethylene oxide (Section 2.3). 

Table  2.  Occupational  exposure  concentrations  (TWA;  exposure  for  working  lifetime)  and  haemoglobin 
adduct  values  corresponding  to  specified  extra  risks  of  lymphoid  cancer  mortality  for  males  and  females 
combined, according to the evaluation of Valdez-Flores et al (2011). 

Extra risk 

4 x 10-3 
1 x 10-3 
4 x 10-4 
1 x 10-4 
4 x 10-5 
1 x 10-5 

12.9  1,2 Epoxypropane 

12.9.1  Identification 

Index Number: 
EC Number: 
CAS Number: 

603-055-00-4 
200-879-2 
75-56-9 

Corresponding TWA 
(ppm) 

corresponding Hb adducts 
(nmol HOEtVal/g globin) 

136.6 
42.1 
17.7 
4.56 
1.83 
0.46 

21.35 
6.58 
2.77 
0.712 
0.286 
0.072 

126 

 
 
12.9.2  Synonyms 

Propylene oxide, methyloxirane 

12.9.3  Classification  according 
carcinogenicity 

to  Regulation 

(EC)  N°  1272/2008  with  regard 

to 

Carc. 1B – may cause cancer 
12.9.4  Classification according to IARC189 

Group 2B - The agent is possibly carcinogenic to humans  
12.9.5  Conclusion of SCOEL190 

The  primary  aspect  to  be  considered  in  deriving  an  OEL  for  propylene  oxide  is  its  local 
carcinogenicity  with  the  nasal  epithelium  as  primary  target,  which  is  well  established 
experimentally in rats and mice. So far, there is no evidence of carcinogenity of propylene oxide 
from studies in humans. 

Propylene  oxide  is  the  methyl  homologue  of  ethylene  oxide.  Like  ethylene  oxide,  it  has 
alkylating  properties.  This  leads  to  hydroxypropylation  of  biological  macromolecules. 
Hydroxypropylation of the N-terminal  valine in haemoglobin is  used  as a  means of biological 
monitoring, and hydroxypropylation of DNA bases is viewed in conjunction with genotoxicity. 
Compared  to  ethylene  oxide,  the  alkylating  power  of  propylene  oxide  is  about  4  times  lower 
(Pauwels and Veulemans, 1998). The metabolism of both, ethylene oxide and propylene oxide, 
is  qualitatively  similar,  via  glutathione  transferase  and  expoxide  hydrolase,  but  differs 
quantitatively.  At  similar  conditions  of  human  industrial  exposure,  the  levels  of  haemoglobin 
alkylation  produced  by propylene  oxide  are  about  10 times  lower  compared to  ethylene oxide 
exposure (Boogaard, 2002). 

In  contrast  to  ethylene  oxide,  the  primary  target  of  both  toxicity  and  carcinogenicity  of 
propylene oxide is at the port of entry into the organism. With inhalation exposure, this is the 
nasal epithelium. The carcinogenic potency at this site of propylene oxide is relatively weak. In 
long-term  experiments  mice,  nasal  tumours  were  observed  at  400  ppm,  and  no  tumours  were 
seen at 200 ppm. In rats, such tumours were detected at 300 ppm, and no tumours were seen at 
the lower concentration of 100 ppm (chapter 2.8.2). 

The EU Risk Assessment Report (ECB 2002) has addressed propylene oxide to be a genotoxic 
carcinogen, without an identifiable threshold. Yet, recent investigations into the mode of action 
of rodent nasal carcinogenesis due to propylene oxide inhalation point to decisive contributions 
of several factors besides genotoxicity. Upon propylene oxide inhalation, glutathione depletion 
is most marked in nasal respiratory mucosa, where a level of only 43% of control was observed 
following a single exposure of rats to 50 ppm for 6 h. At inhalation of 5 ppm the gluthathione 
level at this site was maintained at 90% (Lee et al., 2005; see chapter 2.1.1). This is important, 
because  gluthatione  has  an  important  scavenging  function  in  the  detoxification  of  propylene 
oxide.  For  cytotoxic  and  proliferative  changes  in  the  nasal  epithelium  Eldridge  et  al.  (1995) 
determined a NOAEL of 50 ppm in a 4-week study in rats (see chapter 2.5.2). Similarly, Kuper 
et  al.  (1988)  found  focal  hyperplasia  of  the  nasal  turbinates  and  degenerative  changes  and 
proliferative hyperplasia of the nasal epithelium, particularly at the highest concentration tested 
(300 ppm propylene oxide). At 30 ppm these responses were rated „slight“ and of low incidence 
(and  only  identified  in  the  28-month  treatment  group),  compared  to  the  greater  incidence  of 

189 http://monographs.iarc.fr/ENG/Monographs/vol60/mono60-9.pdf 
190 Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for  propylene  oxide; 

SCOEL/SUM/161; August 2010 

127 

 
                                                 
„moderate“  effects  at  100  ppm  (Reuzel  and  Kuper,  1983,  Kuper  et  al.,  1988).  This  study 
therefore points to a LOAEL of 30 ppm. 

Apart from the local toxic and neoplastic effects of propylene oxide at the portal of entry into 
the  organism,  a  systemic  genotoxicity  must  be  considered.  Occupational  genotoxicity  studies 
performed on propylene oxide are scarce compared to those on ethylene oxide (Preston, 1999; 
Albertini  and  Sweeney,  2002).  Czene  et  al.  (2002),  using  the  parameter  of  sister  chromatid 
exchanges  (SCE)  in  human  lymphocytes,  found  that  SCE  frequencies  at  low  occupational 
exposures  (below  2  ppm  propylene  oxide)  are  not  distinguished  from  those  of  non-exposed 
controls (see chapter 2.6.2). However, in view of the scattering of the general background of this 
parameter and of other arguments (Albertini 2003) the practical relevance of this finding is not 
clear. 

Because there is a well-established mode of action for the local carcinogenicity (Albertini and 
Sweeney,  2002),  propylene  oxide  is  assigned  to  the  SCOEL  carcinogen  group  C,  which  is 
characterised by a practical threshold (Bolt & Huici-Montagud, 2008). 

Considering (i) a LOAEL shown for local changes at the rat nasal epithelium at 30 ppm and (ii) 
an  only  minimal  local  glutathione  depletion  in  the  nasal  tissue  of  the  rats  at  5  ppm,  a  health-
based  OEL  should  be  set  well  below  5  ppm.  A  species  scaling  with  regard  to  humans  is  not 
required  in  this  case,  as  it  is  generally  accepted  that  the  nasal  epithelium  of  rodents  is  more 
susceptible to irritation and irritation-based carcinogenicity than that of humans. Therefore, it is 
proposed  to  set  the  health-based  OEL  for  propylene  oxide  at  1  ppm  [2.41  mg/m3].  This  also 
takes  into  account  the  results  of  Czene  et  al.  (2002)  of  a  no  observed  SCE  effect  in  workers 
below 2 ppm exposure. 

According to Boogaard (2002; see chapter 2.1.3) this OEL corresponds to a BLV of 1.3 nmol N-
(3-hydroxypropyl)-valine haemoglobin adduct per g globin. 

There is no data available to propose a STEL. 

This OEL and BLV derivation is also supported by the following: 

(i) In chapter 2.6.4 it has been deduced that a mean TWA exposure of 2 ppm propylene oxide 
would correspond to a mean DNA adduct frequency of N7-(2-hydroxypropyl)guanine of 3.3 x 
108.  Accordingly,  the  frequency  of  this  major  propylene  oxide  DNA  adduct,  induced  at  the 
proposed OEL, would be 1.65 x108. This is a factor of 20 below the physiological level of the 
corresponding  ethylene  oxide  adduct,  N7-(2-hydroxyethyle)guanine,  in  human  lymphocytes  of 
non-smokers  (Zhao  &  Hemminki  2002;  see  also  SCOEL/SUM/160  for  ethylene  oxide),  and 
confirms that no substantial genotoxic risk is associated with the proposed OEL and BLV. 

(ii) Just recently, Sweeney et al. (2009) have again compiled all arguments, based on mode of 
action,  that  propylene  oxide  represents  a  carcinogen  with  a  practical  threshold.  In  addition  to 
this,  they  also  performed  calculations,  based  on  benchmark  dose  modelling,  of  a  “human 
reference  concentration”  (RfC),  according  to  current  guidance  of  the  U.S.  Environmental 
Protection  Agency  (EPA  2005).  Their  resulting  RfC  values  were  in  a  range  of  0.4  -  0.7  ppm, 
which  is  close  to  the  OEL  proposed  here  based  on  threshold  assumption  and  experimental 
NOAEL/LOAEL. 

There are no data at present on skin absorption of propylene oxide, which could serve as a data 
base for a skin notation. 

12.10 o-Toluidine 

12.10.1 

Identification 

Index Number: 

612-091-00-X 

128 

 
 
EC Number: 
CAS Number: 

202-429-0 
95-53-4 

12.10.2 

Synonyms 

2-aminotoluene 

12.10.3 
carcinogenicity 

Classification  according  to  Regulation  (EC)  N°  1272/2008  with  regard  to 

Carc. 1B – may cause cancer 

12.10.4 

Classification according to IARC191 

Group 1 – The agent is carcinogenic to humans  

12.10.5 

Conclusion of SCOEL 

Is currently being developed. 

12.11 2 Nitropropane 

12.11.1 

Identification 

Index Number: 
EC Number: 
CAS Number: 

609-002-00-1 
201-209-1 
79-46-9 

12.11.2 

Synonyms 

12.11.3 
carcinogenicity 

Classification  according  to  Regulation  (EC)  N°  1272/2008  with  regard  to 

Carc. 1B – may cause cancer 

12.11.4 

Classification according to IARC192 

Group 2B - The agent is possibly carcinogenic to humans  

12.11.5 

Conclusion of SCOEL 

Is currently being developed. 

12.12 Bromoethylene 

12.12.1 

Identification 

Index Number: 
EC Number: 
CAS Number: 

602-024-00-2 
209-800-6 
593-60-2 

12.12.2 

Synonyms 

 

Vinyl bromide 

191 http://monographs.iarc.fr/ENG/Monographs/vol77/mono77-11.pdf 

http://monographs.iarc.fr/ENG/Monographs/vol99/mono99-15.pdf and 
http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F-11.pdf 

192 http://monographs.iarc.fr/ENG/Monographs/vol1-42/mono29.pdf and 
http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-49.pdf 

129 

 
 
 
                                                 
12.12.3 
carcinogenicity  

Classification  according  to  Regulation  (EC)  N°  1272/2008  with  regard  to 

Carc. 1B – may cause cancer 

12.12.4 

Classification according to IARC193 

Group 2A - The agent is probably carcinogenic to humans  

12.12.5 

Conclusion of SCOEL194 

Vinyl bromide is clearly carcinogenic in experimental animals. It has been categorized by IARC 
(2008) as “probably carcinogenic to humans (Group 2A)”. According to the available bioassay 
data the carcinogenic effects are similar to those of vinyl chloride. The close relation between 
vinyl bromide and vinyl chloride is supported by comparative data on metabolism, nucleic acid 
adduct formation and formation of pre-neoplastic hepatic foci. This is consistent with the view 
of  IARC  (2008)  that  vinyl  bromide  should  be  considered  to  act  similarly  to  the  established 
human  carcinogen,  vinyl  chloride.  A  reasonable  quantitative  comparison  of  the  experimental 
carcinogenicity of vinyl bromide and vinyl chloride is possible when toxicokinetic aspects are 
integrated. This leads to the conclusion that in the occupationally relevant low exposure range 
vinyl bromide appears to be about 3 times more active than vinyl chloride. 

Based on the argumentations on the mode of action for vinyl chloride (SCOEL/SUM/109) and 
considering the close similarity of both vinyl halides no threshold mechanism can be supported 
for  both  vinyl  halides.  In  consequence  and  according  to  the  SCOEL  strategy  for  carcinogens 
(Bolt and Huici-Montagud 2008), vinyl bromide is grouped into group A of carcinogens (non-
threshold  carcinogen;  for  low-dose  assessment  of  risk  the  linear  non-threshold  model  appears 
appropriate). 

As the available body of data that can be used for a quantitative assessment of carcinogenic risk 
is  much  larger  for  vinyl  chloride  than  for  vinyl  bromide,  SCOEL  recommends  to  use  the 
existing  quantitative  risk  assessment  for  vinyl  chloride  (SCOEL/SUM/109)  also  for  vinyl 
bromide, considering a three times higher potency of vinyl bromide compared to vinyl chloride. 

The hepatic angiosarcoma risk for vinyl chloride, upon inhalation exposure for working lifetime 
to  1  ppm  inferred  from  epidemiological  data,  has  been  assessed  by  SCOEL  to  be  3  x  10-4
(SCOEL/SUM/109). Independent data, derived from animals and using PBPK modelling, point 
to a similar order of magnitude (between 0.2 and 1.6 x 10-3, and thereby confirm this approach. 
Accordingly,  for  a  similar  exposure  to  vinyl  bromide  the  hepatic  angiosarcoma  risk  is 
considered to be 9 x 10-4. 

12.13 

Hydrazine 

12.13.1 

Identification 

Index Number: 
EC Number: 
CAS Number: 

007-008-00-3 
206-114-9 
302-01-2 

12.13.2 

Synonyms 

Diamide 

193 http://monographs.iarc.fr/ENG/Monographs/vol1-42/mono39.pdf 

http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-40.pdf and 
http://monographs.iarc.fr/ENG/Monographs/vol97/mono97-9.pdf 

194 Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for  vinyl  bromide; 

SCOEL/SUM/155. September 2008 

130 

 
 
 
                                                 
12.13.3 
carcinogenicity 

Classification  according  to  Regulation  (EC)  N°  1272/2008  with  regard  to 

Carc. 1B – may cause cancer 

12.13.4 

Classification according to IARC195 

Group 2B – The agent is possibly carcinogenic to humans 

12.13.5 

Conclusion of SCOEL196 

The relevant toxicological endpoint for hydrazine is carcinogenicity. IARC (1999) has evaluated 
the evidence of carcinogenicity in experimental animals as being sufficient and summarised that 
the compound had been tested by oral administration to mice in several experiments, producing 
mammary and lung tumours. When tested by oral administration or inhalation exposure in rats, 
it produced lung, liver and nasal tumours and a few colon tumours in hamsters; it produced liver 
tumours and thyroid adenomas following oral or inhalation exposure (IARC 1999). 

Among  this  body  of  data,  the  most  useful  information  comes  from  the  long-term  inhalation 
studies and is related to the upper respiratory tract. In mice, exposed in a preliminary study for 6 
months at 0.2, 1, or 5 ppm, there was an increased incidence of pulmonary tumours in all groups 
(Haun  &  Kinkead,  1972;  MacEwen,  1974).  A  subsequent  inhalation  study  in  rats,  mice,  dogs 
and  hamsters  (6h/d;  5d/wk  at  0.05  ppm  [rats,  mice],  0.25  and  1.0  ppm  [rats,  mice,  hamsters, 
dogs] for 1 year with a follow-up for life span or 38 months revealed an increased incidence of 
benign and malignant nasal tumours at 1 and 5 ppm in rats. At 0.05 ppm, the incidence of nasal 
tumours in rats was slightly, but not significantly, over the controls. An increased incidence of 
benign nasal polyps was observed in hamsters at 5 ppm. In addition, hamsters exposed at 0.25 
ppm showed pathological degenerative changes, including amyloidosis. An increased incidence 
of pulmonary adenomas was observed at 1 ppm in mice (MacEwen et al., 1979; Vernot et al., 
1985). 

The evidence of hydrazine carcinogenicity in humans was evaluated by IARC (1999) as being 
inadequate. In the meantime, however, the studies of Ritz et al. (1999, 2006) have pointed to the 
possibility of a carcinogenic effect in exposed areospace workers, in particular to an increased 
lung  cancer  mortality  (see  2.8.1).  This  would  be  compatible  with  the  aforementioned 
experimental data. 

Hydrazine has been characterised as genotoxic. Studies into the mode of action have revealed an 
indirect  mechanism  of  genotoxicity,  involving  reaction  with  endogenous  formaldehyde  and 
ultimate formation of a DNA-methylating agent. 

In principle, the systemic genotoxicity of hydrazine, based on such an indirect mechanism, may 
be  characterised  by  a  threshold  at  low  exposure  levels  (when  hydrazine-induced  DNA 
methylation  becomes  insignificant  vs.  the  normal  methylation  background).  However,  the 
critical target upon occupational inhalation exposure is the respiratory tract, and specific studies 
into the local mode of carcinogenic action, as well as appropriate toxicokinetic modellings, are 
lacking. 

There  are  considerable  species  differences  regarding  hydrazine  carcinogenicity  at  the  upper 
respiratory tract, and caution is warranted in view of the possibility of generation of human lung 
cancer. In this situation, the derivation of a health-based OEL, or a reasonable quantitative risk 
assessment based on experimental tumour data, is not possible at the present time. 

195 http://monographs.iarc.fr/ENG/Monographs/vol1-42/mono4.pdf 

http://monographs.iarc.fr/ENG/Monographs/suppl7/Suppl7-90.pdf and 
http://monographs.iarc.fr/ENG/Monographs/vol71/mono71-43.pdf  

196 Recommendation  from 

the  Scientific  Committee  on  Occupational  exposure  Limits  for  hydrazine, 

SCOEL/SUM/164,, August 2010 

131 

 
                                                 
Therefore,  hydrazine  is  categorised  into  the  SCOEL  carcinogen  group  B,  as  a  genotoxic 
carcinogen,  for  which  the  existence  of  a  threshold  cannot  be  sufficiently  supported  at  present 
(Bolt & Huici-Montagud, 2007). 

The systemic effects seen in animals following dermal contact warrant a 'skin notation'. 

As there are no adequate data, a recommendation for biological monitoring cannot be given. 

132 

 
13  ANNEX 6 - EXPOSURE LIMIT VALUES IN EU MEMBER STATES AND SOME NON-EU COUNTRIES 

Table 1. OELs in EU MS 

Acrylamide 
mg/m3 

Ethylene 
oxide 
mg/m3 

Hardwood 
dust 
mg/m3 

Vinyl 
chloride 
mg/m3 

Silica 
(respirable) 
mg/m3 

RCF3 
f/ml 

1,3 
Butadiene 
mg/m3 

AT  2 
BE  3 
BG  5 
CY  5  
CZ  2,0 
DE  2 
DK  1 
EE  2 
EL  4,92 
ES 
FI 
FR  1 
HR  5 
HU  5 
5 
IE 
5 
IT 
LT  5 
LU  5 
LV  5 
MT  5 

5 
5 / 2  

5 
7,77 
2,5 
7,77 
7,5 
7,77 
3 
3 
7,64 
7,8 
7,7 
2,59 
7,77 
7,77 
7,77 
7,77 
7,77 
7,77 
7,77 
7,77 

0,15 
0,05-0,1 
0,07 
0,3 - 1,01 
0,1 
 - 
0,1 
0,05-0,1 
0,3 - 1,01 
0,05 
0,05 
0.05-0.1 
0,05 
0,15 
0,1 
- 
0,05 - 0,1 
- 
- 
0,0252 

 0,5 
 0,5 
 - 
2 
0,3 
- 
1 
 - 
 - 
0,5 
0.2 
 - 
 - 
1-2 
1 
- 
- 
 - 
- 
0,22 

11 to 34 
4,5 
- 
- 
10 
- 
22 
1 
22 
4,5 
2,2 
 - 
22 
1 
36 
- 
1 
- 
100 
4,4 

Chromium 
(VI) 
compounds 
mg/m3 
0,05-0,1 
0,01 -0,05 
0,05 
2 
0,05 
- 
0,005 
0,02 
0,5 
0.01 -0.05 
0,05 
0,001 
0,05 
- 
0,01-0,05 
- 
0,005 
- 
0,01 
0,01 

0,03-0,06  
0,03 
0,03 
 - 
- 
- 
0,03 
0,03 
0,3 
0,03 
0,3 
0,3 
0,3 
0,03 
0,03 
- 
0,03 
- 
0,2 
–  0,032 

2 
1,8 
2 
90 
1 
- 
1,8 
2 
10 
1,8 
1,8 
1,8 
9,2 
1,8 
10 
- 
2 
- 
1 
1,8 

1,2 
Epoxy-
propane 
mg/m3 
6 
5 
- 
- 
- 
4,8 
12 
5 
50 
4,8 
2,4 
50 
12 
5 
12 
- 
5 
- 
1 
- 

Bromo-
ethylene 
mg/m3 

2-
Nitropropane 
mg/m3 

o-
Toluidine 
ppm 

Hydrazine 
mg/m3 

- 
2,2 
- 
- 
- 
- 
20 
- 
- 
2,2 
4,4 
- 
20 
- 
2,2 
- 
- 
- 
- 
5 

18 
37 
35 
- 
- 
- 
18 
18 
35 
19 
18 
- 
19 
- 
18 
- 
7 
- 
- 
2,2 

0,1 
2 
- 
- 
- 
- 
2 
- 
2 
0,2 
2 
2 
0,2 
- 
0,2 
- 
- 
- 
0,1 
22 

0,13 
0,013 
0,1 
 - 
0,05 
- 
0,013 
0,1 
0,13 
0,013 
0,13 
0,1 
0,03 
- 
0,01 
- 
0,1 
- 
0,1 
- 

 
 
 
 
Hardwood 
dust 
mg/m3 

Vinyl 
chloride 
mg/m3 

Silica 
(respirable) 
mg/m3 

RCF3 
f/ml 

1,3 
Butadiene 
mg/m3 

NL  2 
PL  2 
PT  5 
RO  5 
2 
SE 
5 
SI 
SK  5 
UK  5 

7,77 
5 
7,77 
7,77 
2,5 
7,77 
7,77 
7,8 

0,075 
0,.3 - 1,01 
- 
0,05- 0,1  
0,05- 0,1 
- 
0,1 
0,1 

0,5 
0,5-1 
- 
- 
0,2 
- 
0,8 
1 

46,2 
4,4 
- 
22 
1 
11 to 34 
11 
22 

Chromium 
(VI) 
compounds 
mg/m3 
0,052 
0,025 
0,1 
- 
0,05 
0,005 
2 
0,005 - 0.1 
0,05 

Acrylamide 
mg/m3 

Ethylene 
oxide 
mg/m3 

1,2 
Epoxy-
propane 
mg/m3 

Bromo-
ethylene 
mg/m3 

2-
Nitropropane 
mg/m3 

o-
Toluidine 
ppm 

Hydrazine 
mg/m3 

0,16 
0,1 
- 
0,03 
0,003 
0.03-0,06 
0,03 
0,3 

0,84 
1 
- 
1,8 
2 
2 
2 
9,2 

6 
9 
- 
50 
5 
6 
12 
12 

0,012 
0,4 
- 
22 
- 
- 
- 
- 

0,036 
- 
- 
- 
7 
18 
18 
19 

- 
- 
- 
- 
- 
0,1 
- 
0,2 

- 
0,05 
- 
0,10 
- 
0,13 
0,13 
0,03 

Note 1: OELs are calculated in a case-by-case basis as a function of the % free silica. In the case of Poland, they provide an indicative range: 0.3-1.0 mg/m3, which is assumed here to be the range for CY 
and EL as well. Note 2: Values not included in national legislation but referred from national authorities as to be enforceable (technically sound values published by ACGIH).  

134 

 
 
 
 
 
 
Table 2. OELs in EU MS – compared to levels recommended by the ACSH (option 2) 

Substance 

MS having no or higher OEL 

Total number  

Hardwood dust  BG,CY, EL, ES, FIp, HR,HU,IE, IT,LT, LU, LV,MT,PT, RO, SI, SK,UK 

Vinyl chloride 

Silica 
RCF 

1,3-Butadiene 

AT, BE, CY, CZ, DE, DK, EE, EL, ES, FI, HR, HU, IE, IT, LT, LU, LV, MT, NL, PL, 
PT, RO, SI, SK, UK 
AT, CY, DE, EL, HU, IT, LU, LV,PL, PT, SI 
AT, BE, BG, CY, DE, DK, EE, EL, ES, FR, HR, HU, IE, IT, LT, LU, LV, NL, PL, PT, 
RO, SI, SK, UK 
AT, BE, BG, CY, CZ, DE, DK, EL, ES, FR, HR, IE, IT, LU, LV, MT, NL, PL, PT, RO, 
SI, SK, UK 
AT, BEp, BG, CY, CZ, DE, EL, ESp, FI, HR, HU, IEp, IT, LU, MTp,PL, PT, RO, SI, 
SKp, UK 
CY, CZ, DE, EL, FI, FR, HR, IT, LU, LV, NL, PT, UK 
CY, DE, EL, HR, IE, IT, LU, PT, UK 
AT, BE, BG, CY, CZ, DE, DK, EE, EL, ES, FR, HR, HU, IE, IT, LT, LU, MT, NL, PL, 
PT, RO, SE, SI, SK, UK 

Chromium  (VI) 
compounds 
Acrylamide 
Ethylene oxide 
1,2-
Epoxypropane 
Bromoethylene  AT, BG, CY, CZ, DE, DK, EE, EL, FR, HR, HU, IT, LT, LU, LV, MT,PT, RO, SE, SI, 

SK, UK 

2-Nitropropane  BE, BG, CY, CZ, DE, EL, FR, HU, IT, LU, LV, PL, PT, RO 
o-Toluidine 

BE, BG, CY, CZ, DE, DK, EE, EL, ES, FI, FR, HR, HU, IE, IT, LT, LU, MT, NL, PL, 
PT, RO, SE, SK, UK 
AT, BG, CY, CZ, DE, EE, EL, FI, FR, HR, HU,IT, LT, LU, LV, MT, NL, PL, PT, RO, 
SE, SI, SK, UK 

Hydrazine 

18 

25 

11 
24 

23 

21 

13 
9 
26 

22 

14 
25 

24 

p – partially (the OEL is provided as a range that includes the proposed value) 

135 

 
 
 
Chemical agent 

Australia 

Canada  

US 

China 

Switzerland 

New Zealand 

Japan 

Table 3. OELs in some non-EU countries 

Retained 
option 
2,4 

1 

18  

0,1  

4,37 

1,2 – 
Epoxypropane 
mg/m3  
1,3 Butadiene  
ppm  
2 Nitropropane  
mg/m3  
Acrylamide 
(mg/m3) 
Bromoethylene 
(mg/m3) 
Hexavalent 
Chromium 
(mg/m3) 
Ethylene oxide 
(ppm) 
Hardwood dust 
(mg/m3) 
o-Toluidine (ppm) 
Hydrazine (mg/m3)  0,013  
Refractory Ceramic 
Fibres (f/ml) 
Respirable 
crystalline silica 
(mg/m3) 

0,025  

0,1  

0,3  

0,1  

1  

3  

48 

10 

36 

0,03 

22  

0,05 

1 

1 

2 
0,013  
0,5  

48 (Québec) 

240 

5 

2 

35 (Ontario) 
36 (Québec) 
0,03 

22  

0,05 

1 

1 

2 
0,013  
0,5  

1 

90 

0,03 

n/a 

0,001 
NIOSH 
0,005 OSHA 
1 

n/a 

5 
1,3  
n/a 

2,22  

30 

0,3 

n/a 

n/a 

2  

n/a 

n/a 
0,06  
n/a 

6 

5 

18 

12 

10 

19 

0.03 inhalable 
aerosol 
22  

0.03 

22 mg/m3 

0,05 inhalable 
aerosol 

0,05 

1 

inhalable 

2 
aerosol 
0,1 
0,13  
0,25  

1 

1 

0,2 
0,013  
n/a 

0,2 

n.a. 

n.a. 

n/a 

0.1 

n/a 

0,05 

1 

n/a 

n/a 
n/a 
n/a 

n/a 

0,1 

0,1 

0,05 
(NIOSH) 
30/(%silica+
2)  total  dust 
and 

Inhalable fraction: 
1  (10%  <=  free 
SiO2  <=  50%)0,7 
(50%  <  free  SiO2 
<= 80%) 

0,15 
respirable 
aerosol 

136 

 
 
Chemical agent 

Retained 
option 

Australia 

Canada  

US 

China 

Switzerland 

New Zealand 

Japan 

VCM (ppm) 

1 

5  

1  

10/(%silica+
2)  respirable 
dust (OSHA) 
1  

0,5  (free  SiO2  < 
80%)  

3,85 

2  

5 ppm 

2 ppm 

137 

 
Table 4. Exposures in Member States which have no OEL or an OEL higher that the value proposed by the ACSH (option 2) 

 
 
 
14  ANNEX 7 - RELEVANT EU LEGISLATION 

14.1  Existing EU-OSH framework 

14.1.1  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.  

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”.  

14.1.2  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.197 

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 

197 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 

 
 
                                                 
(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. 

14.1.3  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, 
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 the International Agency for Research on 
Cancer - IARC) as chemical agents, mixtures or processes of equal concern. 

The Directive has been implemented into national law in all Member States. 

14.1.4  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. 

14.2  Internal Market legislation 

14.2.1  REACH Regulation 

REACH  stands  for  Registration,  Evaluation  and  Authorisation  and  Restriction  of 
Chemicals. 

It  requires  all  companies  manufacturing  and  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 

140 

 
health  and  the  environment.  Industry  has  the  burden  of  proving  that  chemicals 
manufactured and placed on the EU market are safe. 

If a safe use cannot be demonstrated, authorities have the possibilities to restrict its use 
by either submitting it to the restriction or the authorisation procedure. 

'Restriction' is the procedure via which the manufacture, use 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, 
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  13  chemical  agents  under  consideration  is  presented  in  the  table 
below. 

Table 1. REACH status of chemical agents in present proposal 

Chemical Agent 

REACH STATUS 

Acrylamide 

RCF 

1,3 Butadiene 

to 

subject 

potentially 

be  made 

1  full  registration  (joint  submission):  100  000  -  1  000 
000  tonnes  per  annum.    2  intermediate  registrations 
(both individual submissions, tonnages undisclosed) 
Added  to  Candidate  List  of  'substances  of  very  high 
to 
concern' 
authorisation.   Restricted  (REACH.XVII.60)  for  use  in 
grouting (significant but narrow worker protection). 
1  full  registration  (joint  submission):  100  000  -  1  000 
000 tonnes per annum 
Added  to  Candidate  List  of  'substances  of  very  high 
concern' 
to 
authorisation.   ECHA  have  recommended  this  agent  be 
added  to  REACH  Annex  XIV.   REACH  authorisation 
regulatory proposal imminent. 
1 full registration (joint submission): 1 000 000 - 10 000 
000 tonnes per annum 

be  made 

potentially 

subject 

to 

Chromium (VI) compounds  Complex  REACH  status  as  there  are  100+  Chromium 

(VI) compounds. 
50  of  these  have  been  pre-registered  but  not  registered 
or  covered  by  authorisation. Others  registered  as  full 

141 

 
and/or intermediate registrations. 
A  subset  of  chromium  (VI)  compounds  are  subject  to 
authorisation.198   Restricted  (REACH.XVII.47)  for  use 
(above  v  low  concentration)  in  cement (ltd.  worker 
protection).  Very widespread and important substance. 
1 full registration (joint submission): 1 000 000+ tonnes 
per  annum.   4  intermediate  registrations  (all  individual 
submissions, 
tonnages  undisclosed).   Also  several 
registrations for related but distinct substances. 
Added  to  Candidate  List  of  'substances  of  very  high 
concern' potentially to be made subject to authorisation. 
1  full  registration  (joint  submission):  1  000  -  10  000 
tonnes  per  annum. Many  registrations  for  related  but 
distinct substances 
Complex registration status.   
As  mineral  substances  which  occur  in  nature  silicone 
dioxide  (i.e.  silica)  is  exempt  from  the  REACH 
registration  obligation.    Further,  RCS  which  meets  the 
proposed  definition  as  a  process  generated  substance 
under CMD would not normally be in scope of REACH 
registration,  which  applies  to  chemical  substances 
placed on the EU market above one tonne per year (and 
hence not to chemical agents generated in situ). 
Nevertheless,  there  are  2  full  registrations  for  silicon 
dioxide (one joint, one individual) at high tonnages and 
many related registrations. 
1 full registration (joint submission): 10 000 - 100 000 tonnes 
per 
individual 
intermediate 
submission, tonnage undisclosed) 
Added  to  Candidate  List  of  'substances  of  very  high 
concern' potentially to be made subject to authorisation.   
3 full registrations:  1 joint submission at 1 000 000 - 10 000 
000  tonnes  per  annum,  2  intermediate  registrations  at  0-10 
tonnes per annum 
Restricted (REACH.XVII.2) for use as an aerosol propellant 
(ltd. worker protection).  Existing BOELV to update. 
Out of scope of REACH 
1 full registration (joint submission): 1 000 000+ tonnes 
per  annum.   Various 
intermediate  registrations  as 
individual submissions, tonnages undisclosed 
2  intermediate  registrations  (individual  submissions, 
tonnages undisclosed) 

annum.   1 

registration 

Ethylene oxide 

Hydrazine 

2 Nitropropane 

(crystalline 

silica, 

RCS 
quartz) 

o-Toluidine 

Vinyl chloride 

Hardwood dust 
1,2 Epoxypropane 

Vinyl 
(bromoethylene) 

bromide 

14.2.2  CLP Regulation 

The  CLP  Regulation  (for  "Classification,  Labelling  and  Packaging")  is  the  EU 
Regulations  which  aligns  the  previous  EU  system  of  classification,  labelling  and 

198 Trichloroethylene,  chromium  trioxide,  chromic  acid,  oligomers  of  chromic  acid  and  dichromic  acid, 
dichromic  acid,  sodium  dichromate,  potassium  dichromate,  ammonium  dichromate,  potassium 
chromate, sodium chromate 

142 

 
 
                                                 
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 Directive199) 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). 

14.2.3  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 
may  maintain 
implement  more 
or 
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. 

Sets  directly-acting  harmonised  standards 
from  which  Member  States  cannot  deviate 
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 

subject 

to 

199 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 

143 

 
 
 
                                                 
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 
this 
given  carcinogen  does  not  alter 
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 
standards 
for  worker  protection  by 
adopting  agreed  positions  on  which 
chemical agents should be made subject to 
EU  level  OELs,  at  what  level,  and  with 
additional commentary where appropriate. 

workers,  the  public,  consumers,  and  the 
environment. 

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. 

144 

 
 
 
 
 
 
15  ANNEX  8  –  GENERAL  INFORMATION  ABOUT  THE  CLASSIFICATION  SYSTEMS 

REFERRED TO IN THE DOCUMENT 

15.1  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) 

15.1.1  Classification according to the CLP Regulation 
The  harmonised  classification200  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  Regulation201.  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. 

200 classification of chemical agents listed in Annex VI to the Regulation 
201 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R1272-

20150601&qid=1447160631531&from=EN  

145 

 
                                                 
15.1.2  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 website202. 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 based203, 
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"204). 

Based  on  its  evaluation,  IARC  classifies  "agents"  in  5  groups  with  regard  to  their 
carcinogenicity to humans205: 

 

 

 

 

 

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.206 

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. 

202 http://monographs.iarc.fr/ENG/Monographs/PDFs/index.php  
203 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. 
204 http://monographs.iarc.fr/ENG/Monographs/vol100F/index.php 
205 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 

206 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. 

146 

 
 
 
                                                 
16  ANNEX 9 – ADDITIONAL GRAPHICAL MATERIAL 

16.1  1,2 Epoxypropane 

Figure 4 - 1,2 Epoxypropane – Current national OELs vs. Option 2  

mg/m3 

60

50

40

30

20

10

0

BG CY CZ IT LU MT PT EL FR RO DK HR IE SK UK PL AT NL SI BE EE HU LT SE DE ES FI LV

1,2-Epoxy-propane - current OELs

Option 2

16.2  1,3 Butadiene 
Figure 5 - 1,3 Butadiene – Current national OELs vs. Option 2207 

120

mg/m3 

100

80

60

40

20

0

BG CY DE FR IT LU PT LV NL IE AT SI DK EL HR RO UK SK CZ BE ES MT PL FI EE HU LT SE

1,3-Butadiene - current national OELs

Option 2

207 Where the OELs have been provided as a range, the upper value has been used in the graph. 

147 

 
 
 
 
 
 
                                                 
Figure 6 - 1,3 Butadiene – Number of exposed workers 208 

Number of workers exposed 

8.000

7.000

6.000

5.000

4.000

3.000

2.000

1.000

0

HR DE FR UK ES PL NL BE CZ RO SE HU FI AT DK BG PT IT EL IE SK SI LT LV EE LU CY MT

16.3  2 Nitropropane 

Figure 7 - 2 Nitropropane – Current national OELs vs. Option 2209 

mg/m3 

40

35

30

25

20

15

10

5

0

CY CZ DE FR HU IT LU LV PL PT RO BE BG EL ES HR UK AT DK EE FI

IE SI SK LT SE MT NL

2-Nitropropane - national OELs

Option 2

208 Data for HR are not known. 
209 ES, HR, UK have an OEL of 19 mg/m3, which is considered approximately equivalent to 18 mg/m3. 

148 

 
 
 
 
 
 
 
 
                                                 
 
Figure 8 - 2 Nitropropane –Number of exposed workers210 

Number of workers exposed 

16.000

14.000

12.000

10.000

8.000

6.000

4.000

2.000

0

HR UK FR DE IT PL ES NL BE RO CZ SE IE EL AT HU DK FI LT PT BG SK SI LV EE CY LU MT

16.4  Acrylamide 
Figure 9 – Acrylamide -  Global polyacrylamide market, 2012-2019 (in 1,000 tonnes)211 

210 Data for HR are not known. 
211 Source: http://www.transparencymarketresearch.com/polyacrylamide-market.html 

149 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
Figure 10 – Acrylamide -  Current national OELs vs. Option 2212 

0,35

mg/m3 

0,3

0,25

0,2

0,15

0,1

0,05

0

CY CZ DE IT LU PT EL FI FR HR UK LV NL PL AT SI MT BE BG DK EE ES HU IE LT RO SK SE

Acrylamide - national OELs

Option 2

Figure 11 – Acrylamide - Number of exposed workers 213 

Number of workers exposed 

12.000

10.000

8.000

6.000

4.000

2.000

0

HR DE UK FR ES PL IT NL RO SE BE HU CZ EL PT DK AT BG FI SK IE LT SI LV EE CY LU MT

212 Where the OELs have been provided as a range, the upper value has been used in the graph. 
213 Data for HR not available. 

150 

 
 
 
 
 
 
 
                                                 
 
 
16.5  Hardwood dust 

Figure 12 – Hardwood dust -  Current national OELs vs. EU OEL and Option 2 

mg/m3 

6

5

4

3

2

1

0

BG CY ES FI HR HU IE IT LT LU LV MT PT RO SI SK UK EL BE AT CZ DE EE NL PL SE DK FR

Hardwood dust - national OELs

Option 2

Current EU OEL

Figure 13 – Hardwood dust - Number of exposed workers 214 

Number of workers exposed 

700.000

600.000

500.000

400.000

300.000

200.000

100.000

0

BG HR RO DE ES UK IT PL FR CZ NL PT HU AT EL DK FI SK SE IE LT BE LV SI EE CY MT LU

214 Data for BG, HR and RO not available. 

151 

 
 
 
 
 
 
 
 
 
                                                 
16.6  Chromium VI 

Figure 14. Overview of Chromium Valence State in Chromium Applications 

Source:  HSE  (2007)  Human  Health  Risk  Reduction  Strategy  for  Chromates  in  IOM  (2011)  Hexavalent 
Chromium, pp. 4 

Figure 15 – Chromium VI -  Current national OELs vs. Option 2215 

2,5

mg/m3 

2

1,5

1

0,5

0

E
D

U
H

T
I

U
L

T
P

I

Y S
C

L
P

L
E

T
A
Chromium (VI) compounds

G
B

Z
C

K
S

I
F

R
H

O
R

K
U

E
I

S
E

E
L
B
N
Option 2 (0.025)

T
M

E
E

V
L

K
D

T
L

E
S

R
F

215 Where the OELs have been provided as a range, the upper value has been used in the graph. 

152 

 
  
 
 
 
                                                 
Figure 16 - Chromium VI - Number of exposed workers 216 

Number of workers exposed 

200.000

180.000

160.000

140.000

120.000

100.000

80.000

60.000

40.000

20.000

0

HR DE IT ES FR UK PL RO CZ NL SE PT HU AT BE BG DK EL SK FI SI LT IE LV EE LU CYMT

16.7  Ethylene oxide 

Figure 17 - The Global Ethylene Trade 

216 Data for HR not available. 

153 

 
 
 
 
 
 
 
 
 
 
 
                                                 
 
Figure 18 – Ethylene oxide -  Current national OELs vs. Option 2 

100

mg/m3 

90

80

70

60

50

40

30

20

10

0

DE IT LU PT CY EL IE HR UK AT BG EE LT SE SI SK FR MT BE DK ES FI HU RO CZ LV PL NL

Ethylene oxide - national OELs

Option 2

Figure 19 – Ethylene oxide - Number of exposed workers 217 

Number of workers exposed 

3.500

3.000

2.500

2.000

1.500

1.000

500

0

HR DE UK FR ES NL PL SE BE RO DK CZ PT AT HU IT FI EL IE BG SK LT SI LV EE LU CY MT

217 Data for HR not available. 

154 

 
 
 
 
 
 
                                                 
 
16.8  o-Toluidine 

Figure 20 - o-Toluidine - Current national OELs vs. Option 2 

2,5

ppm 

2

1,5

1

0,5

0

BG CY CZ DE EE HU IT LT LU NL PL PT RO SE SK MT BE DK EL FI FR ES HR IE UK AT LV SI

o-Toluidine - national OEL

Option 2

Figure 21 - o-Toluidine - Number of exposed workers 218 

Number of workers exposed 

1.400

1.200

1.000

800

600

400

200

0

HR DE FR UK IT ES PL NL BE RO SE CZ HU DK PT AT EL BG FI

IE SK SI LT LV EE LU CY MT

218 Data for HR not available. 

155 

 
 
 
 
 
 
 
                                                 
 
16.9  Refractory Ceramic Fibres (RCF) 
Figure 22 – Refractory Ceramic Fibres (RCF) - Current national OELs vs. Option 2219 

2,5

f/ml 

2

1,5

1

0,5

0

HR BG DE EE EL FR IT LT LU LV PT RO SI HU CY DK IE UK PL SK AT BE ES NL CZ MT FI SE

RCF

Option 2

16.10 Respirable Crystalline Silica (RCS) 

Figure  23  -  Occupational  inhalation  exposure  to  crystalline  silica  (quartz  dust)  in  Finland  in  1950, 
1970,  1990  and  2008  and  predicted  for  2020,  as  measured  by  four  different  metrics  of  exposure220.

219 Where the OELs have been provided as a range, the upper value  has been used in the graph.National 
OELs of CY, HU and SK have been converted from mg/m3 to f/ml. The original values are: CY – 10 
mg/m3, HU – 5-10 mg/m3, SK – 4 mg/m3 

220 Proportional values as compared with 1950 (baseline = 100). 

156 

 
 
 
 
  
 
 
 
 
                                                 
Figure 24 - Respirable Crystalline Silica (RCS) - Current national OELs vs. Option 2221 

1,2

mg/m3 

1

0,8

0,6

0,4

0,2

0

DE LV SI

IT LU PT PL CY EL AT HU CZ DK IE SK UK RO SE BE EE FR LT NL BG ES FI HR MT

RCS - national OELs

Option 2

Figure 25 - Respirable Crystalline Silica (RCS) - Number of exposed workers 222 

Number of workers exposed 

1.600.000

1.400.000

1.200.000

1.000.000

800.000

600.000

400.000

200.000

0

HR ES DE FR UK PL IT RO PT CZ NL EL SE AT BE HU BG DK FI LT SK IE SI LV EE LU CY MT

221 In  the  case  of  countries  with  different  OELs  set  for  the  different  types  of  RCS  (quartz,  cristobalite, 
tridymite),  the  lowest  OEL  is  represented  in  the  graph.  For  instance,  the  quartz  OELs  of  Belgium, 
France, Greece and Estonia are set at 0.1 mg/m3. 

222 Data for HR not available. Where the OELs have been provided  as a range, the upper value has been 

used in the graph. 

157 

 
 
 
 
 
 
 
 
                                                 
 
16.11 Vinyl Chloride Monomer (VCM) 

Figure 26 - Vinyl Chloride Monomer (VCM) - Current national OELs vs. EU OEL and Option 2 

mg/m3 

9

8

7

6

5

4

3

2

1

0

ES UK BE CY DE HR HU IE IT LT LU LV MT NL PT RO SI SK FI EL CZ AT PL DK EE FR BG SE

Vinyl chloride - national OELs

Option 2

Current EU OEL

16.12 Bromoethylene (vinyl bromide)  

Figure 27 - Bromoethylene (vinyl bromide) – Current national OELs vs. Option 2 

25

mg/m3 

20

15

10

5

0

AT BG CY CZ DE EE EL FR HU IT LT LU LV PT SE SI UK SK RO DK HR MT FI ES IE BE PL NL

Bromoethylene - national OELs

Option 2

158 

 
 
 
 
 
16.13 Hydrazine  

Figure 28- Hydrazine –– Current national OELs vs. Option 2 

0,14

mg/m3 

0,12

0,1

0,08

0,06

0,04

0,02

0

SE PT NL MT LU IT HU DE CY SK SI FI EL AT RO LV LT FR EE BG PL CZ UK HR ES DK BE IE

Hydrazine - national OELs

Option 2

Figure 29- Hydrazine - Number of exposed workers223 

Number of workers exposed 

450.000

400.000

350.000

300.000

250.000

200.000

150.000

100.000

50.000

0

HR DE FR UK PL IT ES RO CZ HU NL BG SE AT SK BE PT DK LT FI IE SI LV EL EE LU CYMT

223 Data for HR not available. 

159 

 
 
 
 
 
 
                                                 
 
17  ANNEX 10 – ABBREVIATIONS USED 

ACSH 

Advisory Committee on Safety and Health at Work  

CAD 

CLP 

CMD 

CMR 

DNEL 

ECHA 

EIG 

GIG 

IARC 
mg/m3 

NEPSi 

OEL 

OSH 

PGSs 

ppb 

ppm 

RAC 

RCF 

RCS 

Chemical Agents Directive (Directive 98/24/EC) 

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 

Derived No Effect Level 

European Chemicals Agency 

Employers Interest Group 

Government Interest group 

International Agency for Research on Cancer 

milligram per cubic metre 

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 

part per billion 

parts per million 

Risk assessment Committee of ECHA 

Refractory Ceramic Fibres 

Respirable Crystalline Silica 

REACH 

Regulation  on  Registration,  Evaluation,  Authorisation  and  Restriction  of 
Chemicals (Regulation (EC) No 1907/2006) 

REFIT 

Regulatory Fitness and Performance Programme 

SCOEL 

Scientific Committee on Occupational Exposure Limits 

SMEs 

STEL 

SWD 

SVHC 

TFEU 

TWA 

UN 

VCM 

YYL 

Small and Medium Sized Enterprises 

Short Term Exposure Limit 

Staff Working Document 

 Substance of Very High Concern 

Treaty on the Functioning of the EU 

Time-weighted average 

United Nations 

Vinyl Chloride Monomer 

Years of Life Lost 

160 

 
 
WIG 

WHO 

WPC 

Workers Interest Group 

World Health Organisation 

Working Party 'Chemicals at the Workplace' 

161