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: 2020-09-22
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, 22.9.2020  SWD(2020) 183 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(2020) 571 final} - {SEC(2020) 302 final} - {SWD(2020) 184 final}  
 
 
Table of contents 

1. 

2. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ............................................................... 1 

PROBLEM DEFINITION .................................................................................................................... 5 

2.1.  What is/are the problems? ......................................................................................................... 5 
2.2.  What are the problem drivers? .................................................................................................. 6 
2.3.  How will the problem evolve? ................................................................................................ 11 

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

3.1. 
3.2. 

Legal basis ............................................................................................................................... 12 
Subsidiarity: Necessity and added value of EU action ............................................................ 13 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................... 15 

4.1.  General objectives ................................................................................................................... 15 
4.2. 
Specific objectives ................................................................................................................... 15 
4.3.  Consistency with other EU policies ........................................................................................ 15 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? .................................................................... 17 

Process for setting binding OELs and associated provisions under CMD .............................. 17 

5.1. 
5.2.  Description of the retained policy options  for establishing binding OELs  under the 

CMD ........................................................................................................................................ 17 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ........................................................... 19 

6.1.  Acrylonitrile ............................................................................................................................ 20 
6.2.  Nickel compounds ................................................................................................................... 24 
6.3.  Benzene ................................................................................................................................... 30 

7.  HOW DO THE OPTIONS COMPARE? ............................................................................................ 35 

8. 

PREFERRED OPTIONS .................................................................................................................... 38 

Summary of the preferred options ........................................................................................... 38 
8.1. 
8.2.  Overall impact of the package or preferred options ................................................................ 39 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 45 

9.1.  Monitoring arrangements ........................................................................................................ 45 
Evaluation arrangements ......................................................................................................... 47 
9.2. 

ANNEX 1: PROCEDURAL INFORMATION ............................................................................................ 48 

ANNEX 2: STAKEHOLDER CONSULTATION ....................................................................................... 53 

ANNEX 3: WHO IS AFFECTED AND HOW? .......................................................................................... 63 

ANNEX 4: ANALYTICAL METHODS ..................................................................................................... 70 

ANNEX 5: NATIONAL OELS .................................................................................................................... 96 

ANNEX 6: RELEVANT SECTORS, USES AND ACTIVITIES .............................................................. 110 

ANNEX 7: ROUTE(S) OF EXPOSURE, ADVERSE HEALTH EFFECTS ............................................. 153 

ANNEX  8  – PROCESS  FOR  SETTING  BINDING  OELS  AND  ASSOCIATED  PROVISIONS 

UNDER THE CMD .......................................................................................................................... 156 

ANNEX 9 – OPTIONS DISCARDED AT AN EARLY STAGE .............................................................. 160 

ANNEX 10 – CONSISTENCY AND SYNERGIES WITH THE REACH REGULATION .................... 163 

Disclaimer. Unless otherwise specified, the information and views set out is this report refer to EU28 
aggregated data collected before the 1st February 2020, date of the withdrawal of UK from the EU. 

 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

ABS 

ACSH 

ASA 

BLV 

CAD 

CAREX 

CDB 

CEEMET 

CEFIC 

CESI 

CLP 

CMD 

COPD 

Acrylonitrile-Butadiene-Styrene 

Advisory Committee on Safety and Health at Work 

Finnish Register of Workers Exposed to Carcinogens (altistuminen 
syöpäsairauden vaaraa aiheuttaville tekijöille (ASA-luettelo)) 

Biological Limit Value 

Chemical Agents Directive (Directive 98/24/EC) 

CARcinogen EXposure database 

Current Disease Burden 

Council of European Employers of the Metal, Engineering and 
Technology-based industries 

European Chemical Industry Council 

European Confederation of Independent Trade Unions 

Classification, Labelling and Packaging Regulation  
(Regulation (EC) No 1272/2008) 

Carcinogens and Mutagens Directive (Directive 2004/37/EC) 

Chronic Obstructive Pulmonary Disease 

COWI SA 

Consulting Group 

CSRs 

DALY 

DEEE 

DNEL 

DRR 

ECEG 

ECHA 

EFBWW 

EODS 

EPSU 

ERR 

ETUC 

Chemical Safety Reports 

Disability-Adjusted Life Year 

Diesel Engine Exhaust Emission 

Derived No Effect Level 

Dose Response Relationships 

European Chemical Employers Group 

European Chemicals Agency 

European Federation of Building and Woodworkers 

European Occupational Diseases Statistics 

European Public Service Union 

Exposure Risk Relationship 

European Trade Union Confederation 

EU-OSHA 

European Agency for Safety and Health at Work 

FDB 

GDP 

Future Disease Burden 

Gross Domestic Product 

 
 
 
GDV 

IARC 

INRS 

IMF 

Lat 

LEV 

MaxEx 

MinEx 

MoR 

NACE 

NHS 

OEL 

OSH 

PPE 

PROCs 

PV 

R&D 

RAC 

REFIT 

RMMs 

RMOA 

RPE 

SAN 

SDS 

SLA 

SLIC 

STEL 

SVHC 

SWD 

TFEU 

TWA 

General Dilution Ventilation 

International Agency for Research on Cancer 

Institut National de Recherche et Sécurité 

International Monetary Fund 

Latency 

Local Exhaust Ventilation 

Maximum Exposure  

Minimum Exposure 

Mortality Rate 

Nomenclature des Activités Économiques dans la Communauté 
Européenne 

UK’s National Health Service 

Occupational Exposure Limit (value) 

Occupational Safety and Health 

Personal Protective Equipment 

United Kingdom’s National Health Service 

Present Value 

Research and Development 

Risk Assessment Committee of ECHA 

Regulation on Registration, Evaluation, Authorisation and 
Restriction of Chemicals (Regulation (EC) No 1907/2006) 

Risk Management Measures 

Regulatory Management Option Analysis 

Respiratory Protective Equipment 

Styrene-Acrylonitrile 

Safety Data Sheet 

Service Level Agreement 

Senior Labour Inspectors' Committee 

Short Term Exposure Limit 

Substance of Very High Concern 

Staff Working Document 

Treaty on the Functioning of the EU 

Time-Weighted Average 

 
 
 
UEAPME 

WTP 

European Association of Craft Small and Medium-sized Enterprises 

Willingness to Pay 

 
 
 
1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

Cancer, irrespective of whether it is related to work or not, is the second leading cause of mortality in the 
EU countries after cardiovascular diseases, accounting for about a quarter of all deaths1. It is recognised 
as one of the major contributors to premature deaths in the European Union. It has an impact not only 
on  individual  health,  family  life,  but  also  on  the  national  health  and  social  systems,  the  governmental 
budgets and the productivity and growth of the economy.  

Stepping up the fight against cancer is therefore an urgent priority for the EU. To that end, as announced 
by  European  Commission  President  von  der  Leyen  in  her  Political  Guidelines2,  the  Commission  will 
present  before  the  end  of  2020,  a  European  plan  to  reduce  the  suffering  caused  by  the  disease  and 
support  Member  States  to  improve  cancer  control  and  care  in  order  to  ensure  more  fair  access  to 
treatment across the EU.   

Fighting against occupational cancer is all the more necessary that occupational cancer remains the first 
cause  of  work-related  deaths  in  the  EU3,  as  shown  in  the  figure  1  below.  52%  of  annual  occupational 
deaths  in  the  European  Union  are  currently  attributed  to  cancer,  compared  to  24%  to  circulatory 
diseases,  22%  to  other  diseases  and  2%  for  injuries.  Addressing  occupational  cancer  will  also  be  an 
integral part of the Europe’s Beating Cancer Plan. 

Figure 1: work-related deaths in the EU (2017) 

The initiative comes in the backdrop of an unprecedented crisis for the EU and the world. The Covid-19 
pandemic  has  major  health,  economic  and  social  consequences  that  will  need  to  be  addressed.  The 
pandemic  also  sheds  light  on  the  importance  of  health  and  safety  considerations  in  workplaces, 
especially for those in the front line of the response to crisis. It gives yet another incentive to redouble 
the efforts to protect workers and societies from all possible occupational risks, thereby having a positive 
impact on employment and economy. 

1  https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Cancer_statistics#Deaths_from_cancer  
2    A  Union  that  strives  from  more  –  My  agenda  for  Europe,  available  at:  https://ec.europa.eu/commission/sites/beta-political/files/political-
guidelines-next-commission_en.pdf 
3  EU-OSHA 
accidents 
comparison  of 
https://osha.europa.eu/en/publications/international-comparison-cost-work-related-accidents-and-illnesses/view 

cost  of  work-related 

(2017),  An 

international 

illnesses, 

available 

and 

the 

at: 

 
 
 
 
 
                                                           
A  strong  social  Europe  calls  for  constant  improvements  towards  safer  and  healthier  work  for  all.  As 
outlined  in  the  Communication  on  “A  strong  social  Europe  for  just  transitions,”4  measures  for  the 
protection  of  workers  need  to  keep  up  with  a  wide  range  of  social,  economic  and  technological 
developments  while  at  the  same  ensuring  continuous  protection  from  traditional  risks.  In  this 
Communication,  the  Commission  has  already  committed  to  review  the  occupational  safety  and  health 
(OSH) strategy to address among others the exposure to dangerous substances, with a view to maintain 
European’s high OSH standards. The European Pillar of Social Rights5, jointly proclaimed by the European 
Parliament,  the  Council  and  the  Commission  at  the  Social  Summit  for  Fair  Jobs  and  Growth  on  17 
November 2017, enshrines workers' right to healthy, safe and well-adapted work environment, including 
protection  from  carcinogens.  In  its  Communication  on  “Safer  and  Healthier  Work  for  All,”6  the 
Commission emphasizes that European Union must continue investing in occupational safety and health 
and  has  committed to  step  up  the  fight  against  occupational  cancer through  legislative  proposals.  The 
recent  extension  of  the  Roadmap  on  Carcinogens7  covenant,  which  was  signed  in  Helsinki  on  28 
November  2019,  also  proves  that  a  significant  number  of  stakeholders  continue  to  be  committed  to 
improve the protection of workers from the exposure to carcinogenic substances.     

Reducing  exposure  to  carcinogens  and  mutagens  at  the  workplace  by  setting  EU-wide  occupational 
exposure limit values (OELs) effectively contributes to the prevention of cancer cases and deaths, as well 
as other significant non-cancer health problems caused by these substances. Consequently, it improves 
the  protection  of  workers  by  increasing  the  length,  quality  and  productivity  of  the  working  lives  of 
European  workers  and  ensuring  a  similar  minimum  level  of  protection  across  the  EU,  contributes  to 
better productivity and competitiveness of the EU, and improves the level playing field for businesses.  

In order to further contribute to a better protection of workers, this Commission continues its process of 
updating  the  Carcinogens  and  Mutagens  Directive  (CMD)8  to  keep  abreast  with  the  new  scientific  and 
technical developments and to take account of its stakeholders' views. This is in line with the Directive 
itself,  which  requires  that  OELs  must  be  set  for  all  those  carcinogens  or  mutagens  for  which  this  is 
possible in the light of the available information. Consistency with the REACH Regulation9 is ensured in 
this respect. The finalised REFIT Occupational Safety and Health evaluation10 as well as the conclusions of 
the REACH REFIT evaluation11 have underscored and fed into this process.  

Updating and reviewing the CMD has now become a continuous process 

4  Communication  from  the  Commission  “A  strong  social  Europe  for  just  transitions”  COM(2020)  14  final,  available  at:  https://eur-
lex.europa.eu/legal-content/GA/TXT/?uri=CELEX:52020DC0014  
5  European  Pillar  of  Social  Rights,  November  2017,  available  at :  https://ec.europa.eu/commission/sites/beta-political/files/social-summit-
european-pillar-social-rights-booklet_en.pdf 
6 Communication from the Commission “Safer and Healthier work for All – Modernisation of the EU Occupational Safety and Health Legislation 
and Policy” COM(2017) 12 final, available at : https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52017DC0012 
7 https://roadmaponcarcinogens.eu/about/the-roadmap/ 
8 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. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004L0037 
9 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. Available at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32006R1907 
10  Ex-post  evaluation  of  the  EU  occupational  safety  and  health  Directives  (REFIT  evaluation)  -  SWD(2017)  10  final,  available  at: 
https://ec.europa.eu/transparency/regdoc/?fuseaction=list&coteId=10102&year=2017&number=10&version=ALL&language=en 
11 REACH REFIT evaluation (REACH Review 2017), available at: https://ec.europa.eu/growth/sectors/chemicals/reach/review_en 

2 

 
 
 
                                                           
Over  the  last  few  years,  the  Commission  proposed  three  directives  amending  the  CMD.  These  three 
proposals have been adopted by the European Parliament and the Council12 13 14. These three revisions, 
which  addressed  26  substances,  enabled  among  others  to  revise  two  existing  OELs,  introduce  22  new 
OELs and set a skin notation without any OELs for the remaining two.  

The REFIT OSH evaluation15 says that “following concerns raised by different stakeholders’ groups in the 
evaluation process and in the National Implementation Reports, the need to adopt limit values for more 
substances  should  be  considered.  These  additional  OELs  should  lead  to  a  better  chemical  risk 
management  in  the  future”.  Therefore,  the  Commission  will  continue  the  process  of  updating  and 
reviewing the CMD with the aim to propose new or revised OELs in Annex III to the CMD. 

It is not realistic to set an OEL for every hazardous chemical that may be used at the workplace. Instead, 
it is appropriate to identify and target priority substances. This prioritisation of the substances is based 
on  a  broad  consultative  approach,  including  opinions  issued  by  the  tri-partite  Advisory  Committee  on 
Safety and Health at Work (ACSH), agreement in its Working Party on Chemicals (WPC), and formal two-
stage social partners’ consultation (SPC). 

The  selection  of  the  specific  three  substances  or  groups  of  substances  (hereafter  “substances”) 
considered in this impact assessment,  namely acrylonitrile,  nickel compounds and benzene, folllowed 
the  same  path,  including  a  formal  two-stage  consultation  of  the  European  Social  Partners  launched  in 
July16  and  November  201717,  in  accordance  with  Article  154  of  the  Treaty  on  the  Functioning  of  the 
European Union (TFEU).   

It  was  agreed  by  all  relevant  stakeholders,  taking  into  account  factors  such  as  the  potential  to  cause 
adverse  health  effects,  degree  of  evidence  of  such  effects,  as  well  as  their  severity,  potency  and 
reversibility,  that  these  three  substances  are  of  high  relevance  for  the  protection  of  workers.  The 
Commission's  intention  to  prepare  for  the  establishment  or  revision  of  OELs  for  those  priority 
carcinogens was confirmed and encouraged by all the stakeholders.   

For  the  specific  case  of  benzene,  although  an  EU  OEL  of  3.25  mg/m³  already  exists  in  the  CMD  since 
2004,  the  most  recent  scientific  and  technical  evidence  indicates  that  this  existing  EU  OEL  should  be 
updated.  This  is  in  line  with  the  recital  13  of  the  CMD  laying  down  that  “limit  values  must  be  revised 
whenever  this  becomes  necessary  in  the  light  of  more  recent  scientific  data”.  Furthermore,  the  ACSH 

12  Directive  (EU)  2017/2398  of  the  European  Parliament  and  of  the  Council  of  12  December  2017  amending  Directive  2004/37/EC  on  the 
protection  of  workers  from  the  risks  related  to  exposure  to  carcinogens  or  mutagens  at  work.  Available  at:  https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1571906530859&uri=CELEX:32017L2398 
13 Directive (EU) 2019/130 of the European Parliament and of the Council of 16 January 2019 amending Directive 2004/37/EC on the protection 
of  workers  from  the  risks  related  to  exposure  to  carcinogens  or  mutagens  at  work.  Available  at:  https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1571906467330&uri=CELEX:32019L0130 
14 Directive (EU) 2019/983 of the European Parliament and of the Council of 5 June 2019 amending Directive 2004/37/EC on the protection of 
workers  from 
to  carcinogens  or  mutagens  at  work.  Available  at:  https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1571906381017&uri=CELEX:32019L0983 
15 See footnote 10 
16  Consultation  Document  of  26.07.2017,  First  phase  consultation  of  Social  Partners  under  Article  154  TFEU  on  revisions  of  Directive 
2004/37/EC to include binding occupational exposure limit values for additional carcinogens and mutagens, C(2017) 5191 final. 
17  Consultation  Document  of  10.11.2017,  Second  phase  consultation  of  Social  Partners  under  Article  154  TFEU  on  revisions  of  Directive 
2004/37/EC to include binding occupational exposure limit values for additional carcinogens and mutagens, C(2017) 7466 final. 

the  risks  related 

to  exposure 

3 

 
 
                                                           
strongly recommended the Commission to adopt as soon as possible a revised OEL under the CMD for 
benzene.   

In  order  to  carry  out  its  impact  assessement,  the  Commission  contracted  a  study18  to  COWI  S/A 
(hereafter  “COWI  study”)  in  order  to  collect  the  most  recent  information  for  the  three  substances. 
According to the data arising from this study, more than 1 million EU workers are currently exposed to 
these hazardous substances. This impact assessment aims to assess whether there is a need to introduce 
new  (for  nickel  compounds  and  acrylonitrile)  or  revised  (for  benzene)  OEL  for  these  substances,  to 
address them with other legal or non-legal initiatives, or not to take any action. 

Given the  level  of  scientific  and  technical  knowledge  required  to  identify measures  ensuring  adequate 
protection of workers while being practically feasible for industries, the Commission bases its proposals 
in this area on opinions developed by the ACSH. The  opinions of ACSH take into account  the  scientific 
basis, which is indispensable to underpin OSH legislation. In order to establish this scientific basis for the 
ACSH,  the  Commission  sought  advice  from  the  Risk  Assessment  Committee  (RAC)  of  the  European 
Chemicals  Agency  (ECHA).  This  is  in  line  with  the  REACH  REFIT  evaluation19  in  which  the  Commission 
proposed to “enhance the role of ECHA’s RAC, involving also social partners, to provide scientific opinions 
under  the  OSH  legislation  while  respecting  the  role  of  the  ACSH”  with  the  aim  to  clarify  the  interface 
between REACH and other pieces of EU legislation. 

The  purpose  of  this  impact  assessment  is  to  verify,  on  the  basis  of  available  socioeconomic  data,  the 
robustness of ACSH opinions and, eventually to consider some complementary measures, which could be 
proposed, based on further scientific information.  

Member  States  authorities,  employers'  and  workers'  representative  bodies  within  the  tripartite  ACSH 
strongly anticipate the legal clarity and increased protection which would be the result of new or revised 
OELs of these substances. 

The analysis presented in this document should be read in conjunction with the earlier impact 
assessment (IA)20 for the first proposal, which provided an exhaustive consideration of the CMD, the 
policy and legal context.  

The most essential points are carried over and supplemented by additional information and analysis 
regarding these three additional carcinogens. 

18  COWI  (2019),  collecting most  recent  information  for  a  certain  number  of  substances  with  a  view  to  analyse  the  health,  socio-economic and 
environmental impacts in connection with possible amendements of Directive 2004/37/EC on the protection of workers from the risks related to 
exposure to carcinogens or mutagens at work.  
19 See footnote 11 
20  Commission  Staff  Working  Document,  Impact  Assessment  accompanying  the  proposal  for  a  Directive  of  the  European  Parliament  and  the 
Council  amending  Directive  2004/37/EC  on  the  protection  of  workers  from  the  risks  related  to  carcinogens  or  mutagens  at  work 
(SWD(2016)152final). Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2016:0152:FIN 

4 

 
 
                                                           
2.  PROBLEM DEFINITION 

2.1.  What is/are the problems? 

As  mentioned  in  section  1,  52%  of  annual  occupational  deaths  in  the  EU  are  currently  attributed  to 
cancer. Furthermore, carcinogenic and mutagenic substances lead not only to cancers, but also to other 
important  health  problems.  For  example,  exposure  to  benzene,  in  addition  to  leukaemia,  also  causes 
leukocytopenia, lymphocytopenia, neutrocytopenia and thrombocytopenia. More information about all 
the health effects for the three substances addressed in this initiative are available in table 1.  

As mentioned in the previous section, more than 1 million workers are currently exposed to acrylonitrile, 
nickel compounds or benzene. If no action is taken at the EU level, these workers will continue to run the 
risk of contracting a cancer or other severe health problems.  

Furthermore,  ineffective  prevention  of  the  exposure  to  carcinogens  entails  negative  consequences  for 
business such as higher costs and reduced productivity due to absenteeism, lost expertise and distorted 
competition.  For  Member  States,  this  also  leads  to  increased  social  security  costs  and  missed  tax 
revenues.   

The  problem  tree  below  summarises  the  main  drivers  behind  the  problem  and  the  resulting 
consequences for workers, business and Member States: 

Figure 2: Problem tree 

5 

 
 
 
2.2.  What are the problem drivers? 

2.2.1.  Exposure of workers to carcinogens represents a significant risk to workers’ health 

This  section  presents  an  overview  of  the  estimated  numbers  of  workers  exposed  to  the  substances 
subject to this initiative and a short explanatory summary for each substance. More detailed information 
is provided in annex 6. 

Different sources compile different estimates of the total number of exposed workers. For the purpose 
of this impact assessment, for each substance the most reliable number has been taken forward for the 
baseline scenarios and for the cost-benefit assessments related to the retained options for establishing 
limit values. 

Table 1: Summary of estimates taken forward for the assessment of options 

Health effects caused 

Major occupational exposure 
route  

- Brain, stomach, tongue, 
intestines and 
mammary gland cancer 
- Nasal irritation 

Primary route of exposure is 
through inhalation, although 
exposure can also occur 
through dermal contact. 

- Lung and nasal cancer 
- Pulmonary morbidity 
and miscarriage 

- Leukaemia  
- Leukocytopenia, 
lymphocytopenia, 
neutrocytopenia and 
thrombocytopenia 

Primary route of exposure is by 
dermal contact or by inhalation 
of aerosols, dusts, fumes of 
mists containing nickel. Dermal 
contact may also occur with 
nickel solutions.  

Benzene is readily absorbed by 
all routes (inhalation, dermal 
and oral), of which inhalation is 
the most important route of 
occupational exposure.  

Carcinogen 

Exposed workforce 
(number of workers) 

Acrylonitrile 

10,000 – 33,000 

Nickel compounds  ~87,500 

Benzene 

1,012,500 

Total workforce 
assessed:  

~ 1,121,500 

Based on COWI study (2019) 

Acrylonitrile 

Acrylonitrile is widely used in the aircraft, defence, aerospace and automotive sectors.21 This substance is 
particularly  important  to  ensure  a  transition  to  technologies  which  are  more  environmentally  friendly. 
More information is available at the annex 6. 

21 https://www.petrochemistry.eu/sector-group/acrylonitrile/ 

6 

 
 
 
 
 
 
 
 
 
                                                           
As  shown  in  the  table  1,  between  10,000  and  33,000  workers  are  estimated  to  be  exposed  to 
acrylonitrile  at  their  workplace.  Such  an  exposure  can  lead  to  brain,  stomach,  tongue,  intestines  and 
mammary  gland  cancer,  but  also  to  other  health  problems  like  nasal  irritation.  Although  inhalation  is 
considered as the primary route of exposure, workers can also be exposed through dermal contact.   

Nickel compounds 

Nickel compounds are used in a wide variety of sectors and are usually supplied in granule, powder or 
liquid form. More information about the uses of nickel compounds can be found at annex 6. 

Table 1 shows that around 87,500 workers are currently estimated to be exposed to nickel compounds. 
This  may  have  dramatic  consequences  as  exposure  to  nickel  compounds  can  lead  to  lung  and  nasal 
cancers  but  also  pulmonary  morbidity  and  miscarriage.  The  primary  route  of  exposure  is  by  dermal 
contact or by inhalation of aerosols, dusts, fumes of mists containing nickel. 

Benzene 

Benzene is produced in petroleum refinery and chemical plant processes and is used as an intermediate 
in the production of a wide range of chemical substances. Benzene is also used in the manufacturing of 
some types of rubbers, lubricants, dyes, detergents, drugs, and pesticides.22 More information about the 
production and the uses of benzene are available in annex 6. 

It is assumed that more than 1 million workers are still exposed to benzene and could therefore contract 
different hazardous diseases like leukaemia, as shown in the table 1. Benzene is readily absorbed by all 
routes (inhalation, dermal and oral). Inhalation is the most important route of occupational exposure. 

The table 2 below shows the current and future burden of cancer and other health effects related to the 
occupational exposure to the three substances under consideration. Given the long latency period of the 
illnesses  considered  in  this  impact  assessment,  the  future  health  burden  is  estimated  over  a  60  year 
period. 

However, the disease burden on workers is likely to be underestimated due to several limitations of the 
data/calculations,  which  are  further  explained  in  the  analytical  challenges  section  of  the  annex  4.  For 
instance, the COWI study does not quantify the burden of all cancers and other adverse health effects 
but  only  of  those  which  are  known  to  be  caused  by  the  lowest  exposures  (so-called  most  sensitive 
endpoints).  When  exposed  to  these  substances,  workers  may  develop  additional  types  of  cancer  and 
other  diseases  which  could  be  prevented  by  establishing  an  EU-wide  OEL  as  mentioned  in  the  RAC 
opinions  for  acrylonitrile23,  nickel  compounds24  and  benzene25.  The  table  2  specifies  the  health  effects 

22 ECHA (2018), Background document in support of the Committee for Risk  Assessment (RAC) evaluation of limit values for benzene in the 
workplace. ECHA/RAC/O-0000001412-86-187/F.  
Available at: https://echa.europa.eu/documents/10162/13641/benzene_bg_annex1_en.pdf/37b38de4-0e36-6058-eaa4-1ffc56938831 
23  RAC  opinion  on  acrylonitrile  available  at:  https://echa.europa.eu/documents/10162/13641/acrylonitrile_opinion_en.pdf/102477c9-a961-2c96-
5c4d-76fcd856ac19 
24 RAC opinion on nickel and its compounds available at: https://echa.europa.eu/documents/10162/13641/nickel_opinion_en.pdf/9e050da5-b45c-
c8e5-9e5e-a1a2ce908335 
25  RAC  opinion  on  benzene  available  at:  https://echa.europa.eu/documents/10162/13641/benzene_opinion_en.pdf/4fec9aac-9ed5-2aae-7b70-
5226705358c7 

7 

 
 
                                                           
which have been quantified and not quantified. As these three substances fall under the CMD, in order 
to prevent the whole range of health problems, an OEL can only be established under this directive. 

Furthermore, occupational cancers may develop decades after exposures – including during retirement – 
complicating  the  possibility  of  identifying  a  causal  link,  which  could  lead  to  underestimation  of  the 
disease burden. 

For  the  specific  case  of  benzene,  table  2  shows  that  even  with  an  existing  EU  OEL,  a  high  number  of 
workers can still develop leukaemia and other serious illnesses in the absence of further EU action.  

Table 2 : Current and future disease burden related to occupational exposure to carcinogens (number 
of cases) 

Carcinogen 

Health effects caused 

Acrylonitrile  

Nickel compounds  

Benzene 

Brain cancer (quantified), stomach, tongue, 
intestines, mammary gland cancer (not 
quantified) 
Nasal irritation (quantified) 
Lung cancer (quantified), nasal cancer (not 
quantified) 
Pulmonary morbidity (quantified) 
Miscarriage (quantified) 
Leukaemia (quantified) 
Leukocytopenia (quantified), 
lymphocytopenia, neutrocytopenia and 
thrombocytopenia (not quantified) 

TOTAL 
*      Incidence in 2018 
**   The future health burden is estimated over a 60 year period 
Based on COWI study (2019) 

Current* 
disease burden 
(quantified) 
0.04 – 0.15 

Future** 
disease burden 
(quantified) 
1 – 12 

1.6 – 9.4 
12 

73 - 408 
149 

135 
12 
30 
25 

718 
90 
300 
237 

215.64 - 223.55 

1568 - 1914 

2.2.2.  New  scientific  and  technical  evidence  is  available  that  could  lead  to  updating  of 

existing or establishment of new OELs 

Under  the  CMD,  employers  must  identify  and  assess  risks  to  workers  associated  with  exposure  to 
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. 

For  some  chemical  agents,  the  CMD  establishes  binding  OELs  at  the  EU  level.  The  fact  that  OELs  are 
established  does  not  affect  the  obligations  of  the  employer  to  comply  with  other  rules,  including  to 

8 

 
 
 
 
 
reduce the exposure of his/her workers to carcinogenic and mutagenic substances to as low a level as is 
technically possible (minimisation of the occupational exposure). 

The  existence  of  OELs  provides  clarity  and  OELs  are  very  relevant  benchmarks  for  employers  enabling 
them  to  know  exactly  the  levels  above  which  exposure  cannot  occur.  OELs  also  allow  employers  to 
determine  the  level  below  which  their  risk  management  measures  should  aim  to  comply  with  the 
obligation  to  reduce  the  exposure  to  as  low  a  level  as  is  technically  possible.  To  this  end,  Safety  Data 
Sheets (SDS), and more especially their section 8.1, are very important for downstream users to identify 
and apply appropriate measures in order to adequately control the risk of the chemicals at their site26.  

OELs also support enforcement authorities in controlling that employers are putting in place the relevant 
risk management measures, including those that could contribute to lower the exposure below the OELs.   

Under the CMD, the European Parliament and the Council shall set out limit values in Directives on the 
basis  of  the  available  information,  including  scientific  and  technical  data,  in  respect  of  all  those 
carcinogens  or  mutagens  for  which  this  is  possible,  and,  where  necessary,  other  directly  related 
provisions. 

For  the  substances  covered  in  this  impact  assessment,  the  scientific  advice  has  been  provided  by  RAC 
which adopted its three opinions on 9 March 201827 28 29. The tripartite ACSH also adopted opinions for 
all three on 4 June 201930. It is therefore appropriate to consider updating the CMD based on the above-
mentioned  information.  Further  information  on  the  scientific  advice  and  ACSH  opinions  is  provided  in 
annexes 1 and 2, respectively. 

Among the three substances addressed in this impact assessment, only benzene has already an EU wide 
OEL of  3.25 mg/m³  dated from  2004.  Although  this EU  OEL  already  provides  among  others clarity  and 
support  enforcement  by  authorities  as  explained  above,  the  most  recent  scientific  and  technical 
evidence  indicates  that  it  should  be  updated.  This  is  in  line  with  the  CMD  obligation  to  revise  OELs 
whenever this becomes necessary in the light of more recent scientific data.     

2.2.3.  Diverging national OELs create different competing conditions and protection levels 

across the EU 

The 2004 benzene OEL enabled to set a minimum common protection for all the workers dealing with 
this substance across the EU and limited the different competing conditions. The table 3 below, which 
lists among others the lowest and highest binding national OELs, shows that the Netherlands have set an 
OEL more than four times more stringent than the EU wide OEL. We can also deduce from this table that 
10 countries adopted a level stricter than the EU OEL. Although differences in national OELs for benzene 
remain, this EU OEL limits the scope for divergences. If no EU OEL had been set, we cannot exclude that 
some Member States would not have established a national OEL yet.  

26 ECHA (2018), Guide on Safety data sheets and exposure scenarios.  
Available at: https://echa.europa.eu/documents/10162/22786913/sds_es_guide_en.pdf 
27 See footnote 23 
28 See footnote 24 
29 See footnote 25 
30 The links to these ACSH opinions are available at the Annex II 

9 

 
 
                                                           
Although there is still no EU wide OEL for acrylonitrile, 21 Member States have already set a national OEL 
in  their own  legislation  while  7 Member  States  have  no OELs  yet. These  national  OELs  range  from  0.5 
mg/m³ in Latvia to 7 mg/m³ in Slovenia and Slovakia.  

In the absence of any EU wide OEL for nickel compounds, the table below shows that only a few Member 
States have already set an OEL. However, 19 out of the 23 Member States with no single national OEL for 
nickel compounds have a mix of OELs for some or all of these compounds. Moreover, the strictest OEL 
for nickel compounds is eight times lower than the highest limit value. 

Carcinogen 

Acrylonitrile 

Nickel compounds** 
(inhalable fraction) 

Benzene 

Table 3 : National OELs in EU Member States 

Lowest (strictest) national 
binding OEL 
(mg/m3) 
0.5 
LV  
0.03 
DE 

Highest (least strict) 
national binding OEL 
(mg/m3) 
7  
SI, SK  
0.25 
PL 

0.7 
NL 

3.25 
BE, BG, CY, ES, EL, FI, FR, 
HR, IT, LT, LU, LV, MT, PT, 
RO, SI, SK, UK 

Member States with no OEL 

7  
BG, CY, HR, IT, LU, MT, NL*  
23*** 
AT, BE, CY, CZ, DK, EE, EL, ES, 
FI, FR, HU, HR, IE, IT, LT, LU, 
LV, MT, NL, PT, SI, SK, UK 
0 

* In the Netherlands, in the absence of national OEL, industry is responsible for setting individual OELs. Among these 
substances with no national OEL is acrylonitrile.   
** Single OEL for all the nickel compounds 
*** 19 Member States have OEL(s) for some or all nickel compounds 
Based on COWI study (2019) 

As shown in the table 3, the disparities between the existing national OELs for the three substances are 
high,  which  leads  to  different  level  of  protection  of  the  EU  workers.  In  addition  to  this  main 
consequence,  such  differences  also  cause  complications  for  businesses  operating  in  different  Member 
States and bring confusion to cross-border companies which have to deal with highly diverging OELs. To 
a  lesser  extent,  these  disparities  could  also  provide  potential  incentive  for  companies  to  locate  their 
production  facilities  in  Member  States  with  the  lower  standards,  which  would  prevent  the  smooth 
functioning of the internal market. Such disparities may also be a brake to the freedom of movements of 
workers,  as they  could  renounce  to  accept  a  job  in  another Member  State,  for fear  to  receive  weaker 
health and safety protection. Annex 5 provides an overview of all national OELs in EU Member States for 
the substances considered under this initiative.   

2.2.4.  Modern  production  technologies  allowing  lower  exposure  to  carcinogens  or 

mutagens are not fully exploited 

Although  modern  production  technologies  allow  to  reduce  further  the  occupational  exposure  to 
carcinogenic and mutagenic substances in the workplace, their implementation is not yet generalised in 
all the companies dealing with the three substances addressed in this initiative. One possible reason is 

10 

 
 
 
that  decisions  of  business  are  often  influenced  by  short-term  cost  assumptions  rather  than  long-term 
benefits.  

For example, as regards acrylonitrile, although a significant part of the companies have already a closed 
system  in  place,  some  companies  having  laboratories  using  this  substance  mainly  use  hoods  as 
ventilation system. Moreover, it is assumed that companies operating at low concentration levels usually 
have full enclosure local exhaust ventilation (LEV) while the others have partial enclosure or open hood 
LEV31.  Companies  working  at  higher  levels  of  exposure  should  therefore  invest  in  full  enclosure  LEV 
where possible.  

According to a consultation survey carried out in the framework of the COWI study, companies indicated 
in which types of risk management measures (RMMs) they would invest to comply with OELs of 0.01 and 
0.03  mg/m³  for  nickel  compounds.  As  an  example,  30%  of  the  companies  that  replied  to  this  survey 
would make investments in partial hoods to comply with an OEL of 0.03 mg/m³. This tends to prove that 
companies do not always use the most modern production technologies allowing to reduce the exposure 
to carcinogens or mutagens.  

A  similar  consultation  survey  was  conducted  for  companies  dealing  with  benzene.  During  this  survey, 
several companies indicated that it was possible to reduce further the exposure of workers to benzene, 
meaning that they do not use the most modern production technologies yet.  

2.3.  How will the problem evolve? 

In the absence of EU action, it is estimated that workers exposed to these substances will continue to 
face  the  risk  of  contracting  occupational  cancer  or  other  adverse  health  effects.  Estimations  on  the 
numbers of cancer and other hazardous diseases cases and their associated health costs over a 60-years 
period in case no action is taken are contained in the table 4 below (baseline scenario). 

The  general obligations  set  by the  CMD, employers' actions  and measures  adopted  by  Member  States 
contribute  overall  to  lowering  exposures.  Exposure  levels  have  generally  been  decreasing  in  the  past 
years  and  this  positive  trend  could  continue  in  the  future.  Substitution  may  be  possible  for  some 
carcinogens  in  the  future,  also  the  numbers  of  workers  in  the  industries  using  these  carcinogens  may 
change, and technological developments could facilitate lower exposure concentrations.  

Future forecasts in this area are however far from certain due to scarcity of relevant data and the fact 
that market forces such as raw material and energy prices, developing technology, as well as regulatory 
changes can drive decreases or increases in use which are not easy to predict. Even if trends were overall 
positive, as explained above, the existing employers' practices as well as protective measures at Member 
State  level  do  not  always  reflect  available  scientific  and  technological  knowledge.  For  that  reason, 
assumptions  are  based  on  the  legal  provisions  contained  in  the  CMD,  including  the  minimisation 
requirements,  but  also  on  other  data  including  information  gathered  from  the  stakeholders.  The 
objective has been to define a baseline scenario as close as possible to the future situation. However, it is 
very  challenging  to  anticipate  all  the  developments  over  such  a  long  period.    Further  demographic 

31 See footnote 18 

11 

 
 
                                                           
changes  increase  the  life  expectancy  of  workers  exposed  and,  therefore,  the  chances  to  develop  the 
illnesses mentioned in table 2. More information about the past and future trends regarding the number 
of workers exposed and the exposure concentrations are available in Chapter 6.  

Member States usually do not inform the Commission on their intentions to revise existing or determine 
new  OELs  in  their  national  legislation.  However,  national  administrations  represented  in  the  ACSH  are 
aware of the preparatory work at EU level and therefore it is likely they will await its results in order not 
to duplicate efforts. 

Table 4 - Estimated number of expossed workers, expected number of cancers and other hazardous 
diseases cases and related health costs in case no action is taken (baseline scenario), over a 60 years 
period 

Expected 
no. of 
cases of 
other 
adverse 
health 
effects  
73 - 40833 

Estimated health 
costs 

Possible underestimations 
(non exhaustive list) 

291,000 – 7,446,000   Some health endpoints 

(neurotoxicity, cancer sites 
other than brain) could not 
be quantified 

Some health endpoints 
(sinonasal cancer) could not 
be quantified 

Some health endpoints 
(haematotoxic effects) could 
not be quantified 

80834 

23735 

52,674,000 – 
124,800,000 

202,000,000 – 
331,000,000 

1118 - 
1453 

254,965,000 – 
463,246,000 

Carcinogen 

No. of 
exposed 
workers32 

Expected no. 
of cancer 
cases  

Acrylonitrile 

10,000 - 
33,000 

1 - 12 

Nickel compounds 

~87,500 

149 

Benzene 

1,012,500 

300 

Total 

~ 1,121,500  450 - 461 

Source: COWI study (2019) 

3.  WHY SHOULD THE EU ACT? 

3.1.  Legal basis 

Article 153 TFEU empowers the EU to support and complement the activities of the Member States as 
regards improvements, in particular of the working environment  to protect workers' health and safety 
and to adopt, by means of directives, minimum requirements for gradual implementation, having regard 
to  the  conditions  and  technical  rules  obtaining  in  each  of  the  Member  States.  On  the  basis  of  this 

32 Estimates 
33 Nasal irritation (mortality rate: 0%) 
34 Pulmonary morbidity: 718 (mortality rate: 0%) / miscarriage: 90 (mortality rate: 0%) 
35 Leukocytopenia (mortality rate : 0%) 

12 

 
 
 
                                                           
 
 
provision,  Article  16  (1)  of  the  CMD  provides  a  specific  legal  basis  for  action,  allowing  for  adoption  of 
limit values in respect of those carcinogens or mutagens for which this is possible, having regard to the 
available information, including scientific and technical data. 

3.2. 

Subsidiarity: Necessity and added value of EU action 

Scientific  knowledge  about  carcinogenic  chemicals  is  constantly  developing  and  technological  progress 
enables improvements in protection of workers. In order to ensure that the mechanisms for protecting 
workers from carcinogenic chemicals established in the  CMD are as effective as possible, the Directive 
needs  to  be  kept  up  to  date  with  those  developments.  Updating  the  CMD  to  take  account  of  newer 
scientific evidence is an effective way to ensure that preventive measures would be updated accordingly 
in all Member States.   

The  ex-post  evaluation  of  the  European  Union  occupational  safety  and  health  Directives36  (REFIT 
evaluation)  emphasizes  that  chemicals  classified  as  carcinogens  and  mutagens  continue  to  be 
manufactured across the EU and workers in manufacturing but also downstreams users continue to be 
exposed to them. The main conclusions of this evaluation indicates that the CMD is considered as of high 
relevance. Following concerns raised by different stakeholders’ groups in the evaluation process and in 
the  National  Implementation  Reports,  the  need  to  adopt  limit  values  for  more  substances  should  be 
considered. These additionals OELs should lead to a better chemical risk management in the future. 

This initiative is the fourth update of the CMD aiming to set additional OELs for all those carcinogens or 
mutagens for which this is possible in the light of the available information, as required by the article 16 
of the CMD. In the future, the Commission will continue to evaluate the need to propose additional OELs 
in the CMD and to propose  additional amendments when needed, in collaboration among others with 
the ACSH.  

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

Improved clarity and enforcement 

Establishing new OELs for acrylonitrile and nickel compounds will provide common reference points that 
are used as a practical tool by employers, workers and enforcers to assess compliance with the general 
CMD requirements. OELs can also be used by process plant and machinery designers when planning new 
or considering alterations to existing process plants.  

Clear support for establishing OELs for the substances subject to this initiative has been expressed from 
key stakeholders as it clearly results from the two phases of the consultation of the social partners and 
the opinions of the tripartite ACSH. 

Ensuring a similar minimum level of protection across the EU 

36  Commission  Staff  Working  Document  “Ex-post  evaluation  of  the  European  Union  occupational  safety  and  health  Directives  (REFIT 
evaluation). Available at: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A52017SC0010 

13 

 
 
                                                           
The CMD aims to improve workers’ health and safety by protecting them against risks arising or likely to 
arise from exposure to carcinogens or mutagens at work. This objective is in line with the European Pillar 
of Social Rights and the commitment of President von der Leyen to step up the fight against cancer in the 
context of a European plan against cancer.  

Limit values under the CMD are an important component of the general arrangements for the protection 
of  workers37.  As  laid  down  in  Article  16  of  the  CMD,  limit  values  should  be  established  for  all  those 
carcinogens  and  mutagens  for  which  the  available  information,  including  scientific  and  technical  data, 
makes this possible. Such OELs should also be revised whenever this becomes necessary in the light of 
more recent scientific data38.  

As mentioned in annex 8 related to the process for setting OELs under the CMD, it is not realistic to set 
an  OEL  for  each  hazardous  chemical  that  may  be  used  at  the  workplace.  Therefore,  the  Commission 
identified  acrylonitrile,  nickel  compounds  and  benzene  as  priority  substances,  following  the  procedure 
detailed  in  annex  8.  This  list  of  substances  to  be  addressed  in  the  4th  revision  of  the  CMD  has  been 
approved  by  the  Social  Partners  in  the  context  of  the  formal  two-stage  consultation  for  which  more 
information is provided in annex 2.  

As highlighted in section 2.2.3., the difference between the national OELs may be very high. For instance, 
national  OELs  for  acrylonitrile  range  from  0.5  mg/m³  to  7  mg/m³,  meaning  that  some  Member  States 
have set limit values fourteen times lower than others. And in addition to that, 7 Member States have no 
OELs yet to prevent workers’ exposure to this substance. 

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

With regard to the specific case of benzene, although an EU OEL already exists, its revision will ensure a 
more appropriate minimum level of protection across the EU.   

Contribution to a level playing field  

Employers'  organisations  stressed  in  their  response  to  the  social  partner  consultation  that  setting  EU 
OELs helps to provide a level playing field for industry. The costs of complying with lower national levels 
are generally higher and entail, therefore, a competitive advantage for enterprises operating in markets 
with no or less stringent national OELs. 

Setting  EU  OELs  will  not  completely  eliminate  the  differences  between  Member  States.  Indeed,  they 
retain the possibility to adopt lower limit values as shown for benzene in table 3. However, it will limit 
(acrylonitrile  and nickel compounds) or further limit (benzene)  the scope  for divergences  and enhance 
certainty that there is a core definition and/or enforceable exposure limit for all concerned carcinogens 
in all Member States. 

37 Recital 13 of Directive 2004/37/EC 
38 See footnote 37 

14 

 
 
                                                           
Assuming burdens at EU level related to derivation of limit values  

The process of establishing limit values is very complex and requires a high level of scientific expertise. 
An important advantage of setting OELs at EU level is that it eliminates the need for Member States to 
conduct  their  own  scientific  analysis  with  likely  substantial  savings  on  administrative  costs.  These 
resources  saved  could  instead  be  dedicated  to  improve  further  the  occupational  health  and  safety 
policies in each Member State.  

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

4.1.  General objectives 

The  main  general  objective  of  this  initiative  is  to  ensure  to  the  workers  the  right  to  a  high  level  of 
protection of their health and safety at work, as laid down in the principle 10 of the European Pillar of 
Social  Rights39,  and  to  prevent  death  caused  by  work-related  cancer  and  other  health  problems  as 
mentioned in the Commission Communication on “Safer and Healthier Work for All”40. 

4.2. 

Specific objectives 

The specific objectives are:  

  To further improve protection from occupational exposure to carcinogens and mutagens in the 

European Union; 

  To increase the effectiveness of the EU legal framework by updating it on the basis of scientific 

expertise;  

  To ensure more clarity, facilitate implementation, and contribute towards a better level playing 
field  for  economic  operators  by  adopting  minimum  requirements  at  the  European  level.  The 
existence of OELs provides clarity by determining among others the maximum level of exposure 
with  which  employers  must  comply.  However,  complying  with  the  OELs  does  not  prevent  the 
employers  from  their  other  obligations  pursuant  to  the  CMD,  including  the  reduction  of  the 
exposure as low a level as is technically possible.   

4.3.  Consistency with other EU policies 

Charter of Fundamental Rights of the EU  

The objectives of the initiative are consistent with Article 2 (Right to life) and Article 31 (Right to fair and 
just working conditions) of the EU Charter of Fundamental Rights.  

REACH Regulation 

39 See footnote 5 
40 See footnote 6 

15 

 
 
                                                           
The REACH Regulation41, entered into force in 2007, establishes among others two distinct EU regulatory 
approaches that are restrictions and authorisations. Restrictions enable the EU to impose conditions on 
the  manufacturing,  placing  on  the  market  and/or  use  of  substances,  in  mixtures  or  in  articles,  and 
authorisation  is  designed  to  ensure  that  risk  of  substances  of  very  high  concern  (SVHCs)  is  properly 
controlled  while  promoting  progressive  substitution by  suitable  alternatives  that  are  economically  and 
technically viable42.  

The  applicable  provisions  of  REACH  authorisation  and/or  restriction  of  the  chemical  substances  under 
consideration in this assessment, are as follows43:  

  Restriction: all uses of benzene and its mixtures with some exemptions, the use of nickel and its 
compounds in jewellery and articles which are intended to come into contact with the skin, the 
use of acrylonitrile and its mixtures supplied to the general public.  

  Authorisation: none of these substances are subject to authorisation under REACH.  

More information about the REACH restrictions for the three substances is available in annex 10. 

Having an OEL under the CMD plays an important role in the reduction of worker exposure to benzene. 
Industrial  processes  covered  by  other  EU  legislations  which  set  up  specific  quantity  of  emission  of 
benzene, are indeed not subject to the REACH restriction for this substance44.  

Setting an OEL for nickel compounds under the CMD will also enable to reduce the exposure of workers 
to this group of substances.  

As the REACH restriction for acrylonitrile does not concern the industrial uses, the setting of an OEL for 
this  substance  under  the  CMD  will  improve  the  protection  of  workers  as  they  are  not  covered  by  the 
REACH restriction.   

Europe’s Beating Cancer Plan 

In her political guidelines for the next European Commission45, President von der Leyen recognized that 
there is much more the European Union can do about cancer and committed to put forward a European 
plan to fight cancer. On 4 February 2020, the Commission launched an EU-wide public consultation on 
Europe’s  Beating  Cancer  Plan  on  the  occasion of  a  conference  entitled “Europe’s  Beating  Cancer  Plan: 
Let’s Strive for More”hosted in the European parliament.   

Europe’s  Beating  Cancer  Plan  will  be  structured  around  four  pillars:  prevention,  early  diagnosis, 
treatment and follow-up care. This proposal is fitted with the objectives of the prevention pillar such as 
measures to reduce environmental risk factors, for instance pollution and exposure to chemicals, and in 
particular the reduction of the exposure to carcinogens in the workplace.  

41 See footnote 9 
42  Communication  from  the  Commission  on  Commission  General  Report  on  the  operation  of  REACH  and  review  of  certain  elements  – 
Conclusions and Actions. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52018DC0116&from=EN 
43 A more detailed list of REACH status of the concerned chemical agents can be found in Annex 10 
44 More information about the REACH restriction for benzene is available in Annex 10. 
45 See footnote 2 

16 

 
 
                                                           
5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? 

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

A simplified outline of the process for the development of EU OELs for carcinogens and mutagens is set 
out here. A more detailed description is provided for in annex 8. 

As  mentionned  in  Chapter  1,  the  selection  of  the  specific  three  substances  considered  in  this  impact 
assessment was based on a consultative approach, including opinions issued by the tripartite ACSH and a 
formal two-stage consultation of the social partners.  

It  was  agreed  by  all  relevant  stakeholders,  taking  into  account  factors  such  as  the  potential  to  cause 
adverse  health  effects,  degree  of  evidence  of  such  effects,  as  well  as  their  severity,  potency  and 
reversibility,  that  the  three  substances  are  of  high  relevance  for  the  protection  of  workers.  The 
Commission's  intention  to  prepare  for  the  establishment  of  OELs  for  those  priority  carcinogens  was 
confirmed and encouraged by all the stakeholders.   

Figure 3: simple representation of typical EU OEL setting procedure (Source: ECHA website) 

5.2.  Description of the retained policy options for establishing binding OELs under 

the CMD 

The reference limit values per substance are presented below.   

In addition to the baseline scenario, options for OELs have been considered at the level proposed by the 
ACSH,  including  the  transitional  OELs,  and  at  additional  reference  points  (e.g.  the  strictest  limit  value 
observed among Member States, OELs derived by the RAC). It needs to be noted that the most stringent 
national  OEL  might  not  always  be  feasible  as  an  EU  standard  for  the  following  reasons:  firstly,  the 
substances  subject  to  this  proposal  are  used  in  many  different  industries,  and  for  some  industries  it 
might be difficult to comply with strict OELs due to their specific production processes. Member States 

17 

 
 
 
with the strictest OELs might not host the industries having problems to comply with the strictest OEL. 
Secondly, industries are at different stages in their maturity and use varying technologies and processes. 
Thus,  in  Member  States  and  industries  with  more  advanced  and  automated  production  processes  it 
would be easier to reach a low OEL. However, this cannot prevent the European Union to set a similar 
and adequate minimum level of protection across the EU. These considerations are taken into account in 
the analysis substance by substance. 

All  the  OELs  recommended  by  the  ACSH,  including  the  transitional  limit  values,  as  well  as  the  OELs 
derived by the RAC, are covered by the different scenarios for each substance and are mentioned in the 
table  5  below.  The  OELs  unanimously  recommended  by  the  three  Interest  Groups  of  the  ACSH 
(Employers,  Workers  and  Governments)  have  been  established  through  scientific,  technical  and 
socioeconomic discussion. However, the costs and benefits of the combination of a targeting OEL and a 
transitional  OEL  have  not  been  assessed  in  the  COWI  study.  Therefore,  it  has  not  been  possible  to 
consider them as individual policy options. However, it is reasonable to consider that accompanying an 
OEL with transitional measures would have limited impacts on the benefits and relatively higher impacts 
on the costs. Furthermore, the OELs recommended by the ACSH as transitional OELs are covered by the 
policy options.   

For acrylonitrile, an OEL at the level of the lowest limit value in the Member States and another OEL two 
times  higher  the  OEL  recommended  by  the  ACSH  and  the  RAC  have  been  retained  as  policy  options  . 
These  two  policy  options  for  acrylonitrile  are  reference  points  aiming  to  establish  whether  the  OEL 
recommended by the ACSH is appropriate to follow.    

As in the previous impact assessments, several other options than the retained policy options mentioned 
above have been discarded as they were considered as disproportionate or less effective in reaching the 
objectives of this initiative. More information about these discarded options is available in annex 9. 

Table 5: Options matrix of OELs46 

Carcinogen 

Option 1 
Baseline 

Other options 

Option 2 

Option 3 

Acrylonitrile 

no EU OEL 

0.5 mg/m3 

Nickel compounds 
(inhalable) 

Benzene 

no EU OEL 

1 ppm 
(3.25 mg/m³) 
(current EU OEL) 

0.03 mg/m³ 
(RAC) 

0.05 ppm 
(0.16 mg/m³) 
(RAC) 

1 mg/m3 
(ACSH / RAC) 

0.05 mg/m³ 
(ACSH) 

0.2 ppm 
(0.66 mg/m³) 
(ACSH) 

46 OELs at 8hr TWA 

18 

Option 4 

2 mg/m3 

0.1 mg/m³ 
(ACSH transition value) 

0.5 ppm 
(1.62 mg/m³) 
(≈ ACSH transition value) 

 
 
 
                                                           
 
 
 
 
 
6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? 

Different  policy options  presented  in  the  options matrix  in  table  5  have  been  compared  based  on  the 
methodology  outlined  in  detail  in  annex  8.  Other  options  than  those  supported  by  the  ACSH  in  its 
opinions, such as the OEL recommended by RAC, are presented as reference points for the assessment of 
the ACSH options, to establish whether these are appropriate to follow.  

Analytical methodology  

The  introduction  of  an  OEL  is  expected  to  result  in  a  reduction  in  the  occupational  exposure  to  the 
carcinogen concerned. The extent of such reduction depends on the current levels of exposure, as well 
as on the projected future levels of exposure in the absence of the proposed measure, i.e. the “baseline 
scenario”.  

The  baseline  or  "no  policy  change"  option  includes  all  relevant  EU-level  and  national  policies  and 
measures which are assumed to continue being in force in the absence of further EU action. The baseline 
also takes into account as much as possible how the problem would evolve, considering legal provisions 
contained  in  the  CMD  but  also  all  relevant  societal, economic  and  technical  developments  that would 
probably occur in the following decades. For instance, the expected decrease of the use of petrol due to 
the gradual change to electric vehicles is taken into account. It also includes the existing national OELs, 
the  current  number  of  workers  exposed  and  its  evolution  over  time,  the  current  and  future  exposure 
levels,  the  current  risk  management  measures,  the  voluntary  industry  initiatives,  the  development  of 
new  technologies/growing use  of substitutes, the future use  of the substances and any other relevant 
factors.  

For a given reduction in exposure levels, it is then necessary to estimate the expected decrease in the 
incidence  of  cancer  and  non  cancer  cases  over  a  given  timeframe  to  the  carcinogen  in  question.  This 
requires estimates of the risks of carcinogenicity and other adverse health effects, which can be derived 
from the existing toxicological and epidemiological literature, as well as information about  the current 
level of worker exposure (number of workers, level, duration and frequency of exposure).  

The  health  benefits  of  avoided  cancer  and  non-cancer  diseases  registrations  and  deaths  can  then  be 
expressed  in  monetary  terms  by  applying  standard  evaluation  methods47,  in  line  with  the  Better 
Regulation Toolbox guidance. These health benefits of implementing new or revised OELs are calculated 
in terms of the costs of ill health avoided.  

These monetised health benefits  can in turn be  compared to the  expected monetary  costs that would 
have  to  be  incurred  in  order  to  comply  with  the  proposed  OEL.  The  estimate  of  the  costs  was  made 
based on a literature research and data obtained from stakeholder contacts and take into account the 
following factors: the RMMs needed to comply with the proposed OEL, the costs of these RMMs for each 
company, the life span of the RMMs and the number of companies. The monetised health benefits are 
also compared to the other costs, including costs for public authorities, as well as to the potential effects 
on the market for the substance by the imposition of an OEL.  

47 The valuation of health impacts was undertaken based on two approaches. Approach one is the application of a single willingness to pay (WTP) 
value to each case and approach two is the use of disability adjusted life years (DALYs) and their monetisation. 

19 

 
 
                                                           
The benefits and costs of possible OELs are measured against the baseline, meaning that only marginal 
costs and marginal benefits are taken into account (for example,  additional costs added to the current 
costs to comply with REACH regulations). 

Given  the  complementarity  between  the  regulation  under  REACH  and  the  minimum  requirements 
established through the CMD, the past  and present REACH measures have  been specifically  taken into 
account in assessing the baseline and the impacts of the proposed CMD measures for all substances in 
this report. 

More  information about  the  analytical methodology, but  also some analytical challengens arising from 
this cost-benefit analysis, are further discussed in annex 4.  

6.1.  Acrylonitrile 

Baseline 

Approximatively  10,000  to  33,000  workers  in  the  EU  are  exposed  to  acrylonitrile,  depending  on  the 
sources of data used for the calculation48.  

The  sectors  using  acrylonitrile  that  have  been  examined  for  this  impact  assessment  are  industrial 
manufacturing,  manufacture  of  textiles,  leather  and  fur,  manufacture  of  bulk,  large  scale  chemicals 
(including petroleum products),  manufacture of fine chemicals, formulation of preparations and/or re-
packaging  (excluding  alloys),  manufacture  of  rubber  products,  manufacture  of  plastics  products 
(including  compounding  and  conversion),  manufacture  of  computer,  electronic  and  optical  products, 
electrical  equipment,  building  and  construction  work,  health  services,  professional  use,  scientific 
research and development.  

Acrylonitrile  is  not  subject  to  authorisation  according  to  Annex  XIV  of  REACH  but  its  use  is  restricted 
under Entry 28 of Annex XVII under the REACH Regulation49. However, this restriction only concerns the 
general public and not workers.  More information about this restriction can be found in annex 10 of this 
impact assessment. There is not yet any OEL for acrylonitrile at the EU level. 

It  is  assumed  that  the  number  of  exposed  workers  remained  constant  in  the  past  and  will  remain 
unchanged in the future. Annual declines of 3%50 and 0%51 in exposure concentrations are respectively 
assumed for the current and future disease burdens. In addition to that, a 5% staff turnover is taken into 
account for calculation purposes. The future disease burden only reflects cases occurring as a result of 
future exposure, leading to underestimated numbers of cancer52.  

48 Carex EU and Acrylonitrile Sector Group data. 
49  Substances  listed under  Entry  28  are  not  to be  placed  on  the  market  for  use  by  the  general  public  ‘when  the  individual concentration  in the 
substance or mixture is equal to or greater than’ either the ‘relevant specific concentration limit’ specified in Part 3 of Annex VI to Regulation 
(EC) No 1272/2008 or the ‘relevant generic concentration limit’, specified in Part 3 of Annex I to Regulation (EC) No 1272/2008. Suppliers shall 
ensure before placing on the market that the packaging of such substances and mixtures is marked as ‘Restricted to professional users’ 
50 COWI study (based on a study on workers exposed to acrylonitrile and published in the Scandinavian Journal of Work, Environment & Health).  
51 The null trend for the future exposure concentrations is explained among others by the fact there is no data suggesting a change of the exposure 
levels. 
52 Additional information about the analytical challenges leading to potential over- and underestimations is available at Annex IV, section 3. 

20 

 
 
                                                           
In the absence of any further action, up to 12 new brain cancer and 408 nasal irritation cases resulting 
from future exposure are estimated to occur in the coming 60 years, which would cost respectively up to 
€5,692,000 and €1,754,000. With regard to brain cancer, a 30 years latency period and a mortality rate 
of 80% are assumed.  It should be borne in mind that only two health endpoints (brain cancer and nasal 
irritation) have been used in this impact assessment, which could lead to underestimate even further the 
exact number of cancer cases and other adverse health effects. 

Table 6: Baseline scenario over 60 years for acrylonitrile 

Types of cancer caused 

Brain (quantified), stomach, tongue, intestines, mammary gland 
(not quantified) 

Other adverse health effects 

Nasal irritation (quantified) 

No. of exp. workers 

Change exp. level 

Change no. of exp. workers 

Current disease burden (CDB) - no. of brain 
cancer cases 

10,000 to 33,000 

Past: 3% 
Future: 0%  

Past: 0% 
Future: 0%  

0.04-0.15 

Future disease burden (FDB) - no. of brain 
cancer cases 

1–12 

CDB no. of other adverse health effects 

Nasal irritation: 1.6-9.4 

FDB no. of other adverse health effects 

Nasal irritation: 73–408 

0.8 – 9.6 

Presumed 0 

Method 1: €417,000–€5,692,000 
Method 2: €269,000–€3,678,000 

Method 1: €22,000–€121,000 
Method 2: €314,000–€1,754,000 

Exp. no. of deaths FDB cancer 

Exp. no. of deaths FDB other adverse health 
effects 

Monetary value FDB brain cancer 

Monetary value FDB other adverse health 
effects 

Based on COWI study (2019) 
*Workforce turns over at 5% p.a. 

Impacts of the policy options 

The table 7 below shows the multi-criteria analysis, summarizing both the monetised impacts as well as 
those that are assessed qualitatively.  

In its opinion53, RAC derives a limit value of 1 mg/m³ (0.45 ppm) which assumes a mode of action-based 
threshold  for  the  carcinogenic  effects  of  acrylonitrile.  RAC  also  recognises  that  “there  may  be 
occupational tasks at industrial sites presenting a short term acute exposure risk”. For that reason, It also 

53 See footnote 23 

21 

 
 
  
                                                           
derives a short-term exposure limit (STEL) of 4 mg/m³ (1.8 ppm). The costs and benefits for STEL values 
could  not  be  monetised  for  acrylonitrile.  However,  the  three  Interest  Groups  in  the  ACSH  opinion 
recommended the same OEL and STEL as RAC accompanied with a 4-years transition period starting from 
the entry into force of the Directive revising the CMD.   

Although  the  main  route  of  occupational  exposure  to  acrylonitrile  is  by  inhalation  of  the  vapour,  RAC 
noted that dermal exposure is also possible. Acrylonitrile can indeed readily penetrate the skin. For that 
reason, RAC recommended to set a skin notation. This skin notation has also been recommended by the 
ACSH. 

Compliance cost levels for companies generally depend on the extent to which exposures are currently 
close  to  the  required  OELs.  The  higher  the  difference  between  the  current  exposure  levels  and  the 
required OEL is, the higher the investments in RMMs will be. Since the exposure levels in the different 
sectors  using  acrylonitrile  are  already  very  low,  the  compliance  costs  for  companies  should  be  very 
limited.  

Complying  with  an  OEL  of  1  mg/m³  as  recommended  by  the  RAC  and  the  ACSH  would  cost  to  the 
employers €28,000,000 over a 60 years period, which corresponds to between 0.02% and 0.07% of the 
turnover,  depending  on  the  current  average  exposure  and  the  size  of  the  company.  This  is  not 
considered  to  be  significant  enough  as  to  force  companies  to  cease  operating.  However,  these 
compliance costs have to be entirely considered as one-off costs which will be dedicated to investements 
in LEVs. A transition period could therefore be necessary to mitigate the adverse effects of such upfront 
effort  by  enabling  companies  to  anticipate  the  changes,  more  gradually  introduce  improvements  and 
plan  the  necessary  investments.  In  the  event  of  the  introduction  of  an  OEL  of  0.5  mg/m³,  compliance 
costs would represent  up to 0.12% of the  turnover and could, therefore,  have more consequences  for 
companies.   

Some  of the costs  included in the  estimated compliance  costs  concern RMMs that may be  required in 
any case to control exposure to other substances, leading to a possible compliance costs overestimation. 

Given their lower  turnovers, SMEs  usually encounter more  difficulties to comply with lower OELs than 
the large companies. For an OEL of 1 mg/m³, it is estimated that SMEs will have to invest up to 0.07% of 
their 60-years turnover  while  larger  companies could only  need to invest 0.02%  of their turnover. The 
estimated  costs  for  this  scenario  therefore  remain  relatively  low  and  no  SMEs  are  expected  to  close 
down. However, as mentioned above these costs will be one-off costs and a transition period could be 
needed for companies, especially SMEs that might need more time to manage the investments. In the 
event that the OEL would be set at 0.5 mg/m³, SMEs could face compliance costs of up to 0.12% of their 
turnover.  

The  impact  of  introducing  any  of  the  OELs  on  competitiveness  are  estimated  to  be  relatively  modest. 
Only  a  very  limited  number  of  companies  interviewed  mentioned  that  the  introduction  of  an  EU  OEL 
could  have  a  moderate  or  even  significant  impact.  With  regard  to  research  and  development  (R&D) 
expenditures, even if the estimates of the costs  arising from the implementation of the different OELs 

22 

 
 
represent  a  relatively  small  percentage  of  overall  turnover,  they  still  represent  an  increase  in  costs 
compared to the current situation, which may slightly put the R&D expenditures under pressure.  

As no closures have been estimated for any of the OELs suggested in this impact assessment, it is likely 
that  there  would  be  low  or  very  limited  impacts  on  workers  in  terms  of  employment.  With  regard  to 
environmental aspects, the impact of setting an OEL for acrylonitrile should also be very limited. People 
living close  to acrylonitrile productions are indeed exposed to very low  levels of acrylonitrile  in the air 
and  the  introduction  of  an  EU-wide  OEL  should  not  lead  to  higher  levels.  In  addition  to  that,  the 
overwhelming majority of the companies dealing with acrylonitrile already uses waste water treatments 
to avoid any contaminations by water.54 

Setting an OEL of 2 mg/m³ or above would have very limited benefits for the workers and their families55 
and no benefits for the companies and the public sector. The benefits associated with an OEL of 1 mg/m³ 
or 0.5 mg/m³ would be exactly the same for the workers and their families as well as for the companies. 
The benefits for the public sector associated with an OEL of 0.5 mg/m³ would be slightly higher than with 
an OEL of 1 mg/m³.  

Administrative costs56 for Member States will depend on whether they already have a national OEL lower 
or equal to the proposed EU OEL for acrylonitrile. As mentioned in the table below, all Member States 
except  Latvia  would  have  to  revise  their  national  OEL  in  the  event  of  option  2  or  3.  According  to  the 
estimates, administrative  costs  would be  of 50,000€ per Member State. In the event of option 4, only 
Latvia, Poland and Czech Republic would not need to transpose the new EU OEL.  

Table 7: Multi-criteria analysis on acrylonitrile (all impacts over 60 years and additional to the 
baseline) 

Impact 

Stakeholders 
affected 

Option 2 
0.5 mg/m³ 

OEL options 

Option 3 
1 mg/m³ 
(ACSH) 

Option 4 
2 mg/m³ 

Economic impacts 

Compliance costs (one-off 
and recurrent) 

Compliance costs (one-
off)* 

Compliance costs 
(recurrent)* 

Companies 

€146,000,000 

€28,000,000 

€280,000 

Companies 

€132,000,000 

€30,000,000 

€7,800,000 

Companies 

€13,300,000 

-€2,000,000 

-€7,500,000 

Compliance costs as a 
percentage of turnover for 
an average company 

Companies 

0.02%-0.12% 
depending company size 
and current exposure level 

0.02%-0.07% depending 
company size and current 
exposure level 

Monitoring 

Companies 

€0 

Administrative costs 

Public sector 

€1,350,000 

€0 

€1,350,000 

Negligible 

€0 

€1,250,000 

54 European Chemicals Bureau (2004), “European Union Risk Assessment Report for Acrylonitrile. Report by Institute for Health and Consumer 
Protection for the European Chemicals Bureau. Available at: https://echa.europa.eu/documents/10162/22bf49d3-e951-44b8-a45a-6973d3dc62f6 
55 Workers’ families can be affected in different ways (treatment costs, pain from seeing a member of the family suffering from  cancer, caring 
duties, lost income, etc.). More information is available in Annex on the analytical methods. 
56 Administrative costs are costs that Member States will face when transposing the relevant changes into national legislation. 

23 

 
 
                                                           
Avoided costs** 

Companies 

Avoided costs*** 

Public sector  

Single market: 
competition - No. of 
company closures 

Companies 

Single-market: consumers 

Consumers 

Single market: internal 
market**** 

Companies 

€ 340,000–  
€ 1,100,000 

€ 27,000–  
€ 89,000 

0 

€ 340,000–€ 1,100,000 

€ 27,000– 
€ 89,000 

0 

Limited impacts expected 

€0–€0 

€0–€0 

0 

Highest /lowest OEL 
 from 9 to 1 

Highest /lowest OEL 
 from 9 to 2 

Highest /lowest OEL 
 from 9 to 4 

Companies 

Limited***** 

N.A. 

N.A. 

Public sector 

All Member States except 
LV 

All Member States except LV 

All Member States except 
CZ, PL and LV 

International 
competitiveness 

Specific MSs/regions - MSs 
that would have to change 
OELs 

Social impacts 

No. of avoided cancer 
cases (brain cancer) 

No. of avoided  cases 
(nasal irritation) 

Avoided costs of ill health, 
incl. intangible costs – 
METHOD 1 

Avoided costs of ill health, 
incl. intangible costs – 
METHOD 2 

Employment – Jobs lost 

Workers & 
families 

Workers & 
families 

Workers & 
families 

Workers & 
families 

Workers & 
families 

Employment – Social cost  Workers & 

families 

Environmental impacts 

Environmental releases 

All 

1–12 

73–408 

1–12 

73–408 

0–1 

28–176 

€ 440,000 - € 5,800,000 

€ 440,000 - € 5,800,000 

€ 110,000 - € 510,00 

€ 583,000 - € 5,430,000 

€ 583,000 - € 5,430,000 

€ 185,000 - € 1,050,000 

0 

€0 

0 

€0 

Limited impact 

0 

€0 

Based on COWI study (2019) 
* one-off and recurrent costs have been rounded in the COWI study so that the total of these two lines may not correspond to the total 
compliance costs.   
** Including payments related to sick leave, absence from work, insurance premiums 
*** Including heathcare, loss of tax revenue 
**** Internal market shows the ratio of highest to lowest OEL before and after implementing the OEL option 
***** Approximatively 20% of the companies surveyed in the framework of the COWI study are of the view that the introduction of an OEL of 
0.03 mg/m³ would have a moderate or significant impact on their competitiveness outside the EU. This consultation has not been carried out for 
the two other scenarios. 

6.2.  Nickel compounds 

Baseline 

Around  87,500  workers  in  the  EU  are  estimated  to  be  exposed  to  nickel  compounds  in  the  sectors 
considered in this impact assessment, namely oil refineries, pigments, frits, catalysts, glass, metals and 

24 

 
 
 
alloys, metal surface treatment57, batteries, materials recovery and welding. Some sectors have not been 
considered in this impact assessment for the following reasons:  

Lack of source of information: agriculture;  

 
  Marginal  exposure  or  activity  in  the  EU:  mining  and  metal  ores,  manufacture  of  basic 

pharmaceutical products and pharmaceutical preparations, sewerage; 

  Considered  as  covered  by  other  sectors:  manufacture  of  other  inorganic  base  chemicals, 

manufacture of abrasive tools. 

Lung cancer is the main cancer endpoint due to an exposure to nickel compounds. The exposure to this 
group  of  substances  can  also  lead  to  other  adverse  health  effects  like  pulmonary  morbidity  and 
miscarriage. Exposure to nickel compounds can also lead to sinonasal cancer. However, this endpoint is 
supposed  to  occur  at  concentrations  above  those  at  which  lung  cancer  occurred,  and  has  not  been 
considered in this impact assessment.  

Nickel  compounds  are  not  subject  to  authorisation  according  to  Annex  XIV  of  REACH.  However,  as 
indicated in Annex XVII of REACH (entry 27), the use of nickel and its compounds in jewellery (including 
watches)  and  articles  that  come  into  contact  with  the  skin  is  restricted.  More  information  about  this 
restriction can be found in annex 10 of this impact assessment.In addition, all the nickel compounds and 
their mixtures cannot be supplied to the general public due to the restriction entry 28 of Annex XVII to 
REACH, similar to the previous case of acrylonitrile.  

The  exposure  levels  used to  estimate  the  current  and  future  burdens of  disease  vary  from  a  sector  to 
another58. It is assumed that the number of exposed workers remains constant both for the current59 and 
future60 burdens of disease. A mean latency period of 5 years for lung cancer (with a mortality rate of 
80%) has been used for the calculations while it is assumed that there was no latency and a zero worker 
mortality rate for pulmonary morbidity and reproductive toxicity (miscarriage). The calculations enabling 
to estimate the number of miscarriage cases have been based on the workforce adjusted to represent 
those of reproductive age.   

In the absence of any further action, 149 lung cancer, 718 pulmonary morbidity and 90 miscarriage cases 
could occur over the next 60 years, which would correspond to a total health cost between 53 and 125 
million EUR.  

Table 8: Baseline scenario over 60 years for nickel compounds 

Types of cancer caused 

Lung cancer (quantified), nasal cancer (not quantified) 

Other adverse health effects 

Pulmonary morbidity, miscarriage (quantified) 

No. of exp. workers 

Change exp. level 

87,488 

Differs by sector  

57 This sector also covers specialist metal surface treatment companies which focus upon a particular sector or product and consider themselves as 
being covered by NACE codes linked to these particular sectors or products rather than metal surface treatment.    
58 More information is available in Annex 6 
59 Data from 1990 to present day was used in the COWI study to develop the exposure concentrations for past exposures.  
60 Data from 2010 to present day was used in the COWI study to develop the exposure concentrations for future exposures.  

25 

 
 
                                                           
Change no. of exp. workers 

Current disease burden (CDB) - no. of 
lung cancer cases 

Future disease burden (FDB) - no. of lung 
cancer cases 

CDB no. of other adverse health effects 

FDB no. of other adverse health effects 

Past: 0%  
Future: 0% 

22  

149 

Pulmonary morbidity: 135  
Miscarriage: 12 

Pulmonary morbidity: 718  
Miscarriage: 90  

Exp. no. of deaths FDB lung cancer 

98  

Exp. no. of worker deaths FDB other 
adverse health effects 

Monetary value FDB cancer 

Monetary value FDB other adverse health 
effects 

Pulmonary morbidity: 0  
Miscarriage: 0  

Method 2: €43 million  
Method 1: €69 million  

Pulmonary morbidity:  

  Method 1: €9 million  
  Method 2: €54 million  

Miscarriage:  

  Method 2: €674,000  
  Method 1: €1.8 million  

Based on COWI study (2019) 
*Workforce turns over at 5% p.a. 

Impacts of the policy options 

In its opinion on nickel and its compounds61, RAC derives an OEL for respirable fraction of 0.005 mg/m³ 
(to  protect  against  lunger  cancer)  and  an  OEL  for  inhalable  fraction  of  0.03 mg/m³  (to  protect  against 
sinonasal cancer).  

RAC  also  recommends  a  skin  and  respiratory  sensitisation  notation  as occupational  exposure  to  nickel 
compounds  may  result  in  contact  sensitisation  and  in  rare  cases  also  sensitisation  of  the  respiratory 
tract.  

In  the  ACSH  opinion,  the  three  Interest  Groups  support  the  notations  and,  after  considering  also 
feasibility  and  socio-economic  aspects,  recommend  both  an  OEL  of  0.01  mg/m³  for  the  respirable 
fraction (which would apply  from January 2025, after a transitional period) and an OEL of 0.05 mg/m³ 
inhalable fraction (with a transitional OEL of 0.1 mg/m³ for the inhalable fraction which would apply until 
January 2025).    

61 See footnote 24 

26 

 
 
 
                                                           
The  multi-criteria  analysis  indicating  impacts  and  stakeholders  affected  is  summarised  in  the  table  9 
below. Unless otherwise specified, the limit value mentioned in this impact assessment is based on the 
inhalable  fraction.  Due  to  limited  availability  of  relevant  data,  the  impact  of  changes  related  to  the 
respirable fraction could not be fully assessed.  

The  compliance  costs  represent  the  needed  investments  in  RMMs  to  comply  with  the  proposed  OEL. 
Complying with an OEL of 0.03 mg/m³ would cost €11 billion to the companies over the next 60 years. 
These compliance costs would decrease to €4.3 billion and €947 million for an OEL of 0.05 mg/m³ 62 and 
0.1 mg/m³  63, respectively. The costs of compliance with an OEL of 0.05 mg/m³ and above represent a 
sustainable  percentage  of  overall  turnover,  even  for  SMEs.    Small  companies  operating  in  the  oil 
refineries,  welding  and  metals  sectors  would  be  the  most  affected  and  would  have  to  invest  0.18%, 
0.15% and 0.12% of their turnover over the next 60 years, respectively. However, these compliance costs 
would have to be entirely considered as one-off costs which would enable to invest in new RMMs. In the 
event of an OEL of 0.03 mg/m³, these compliance costs for companies in the oil refineries, welding and 
metal  sectors  would  represent  0.37%,  0.31%  and  0.31%  of  their  turnover  over  the  next  60  years, 
respectively.  

To  prove  their  compliance  with  an  OEL,  companies  have  to  monitor  the  exposure  of  their  workers.  In 
order  to  comply  with  the  OELs  recommended  by  the  ACSH,  the  companies  could  be  required  to  also 
measure  the  exposure  of  the  respirable  fraction.  The  average  cost  of  measurement  for  both  the 
inhalable and respirable fractions, irrespective of the OELs level, would be of €152,000 every five-years 
over the next 60 years for large companies, €76,000 for medium companies and €38,000 for small ones. 
For small companies operating in the metal surface treatment sectors, this could represent more  than 
0.3%  of  their  turnover.  Therefore,  it  is  important  to  take  into  account  both  the  compliance  and 
monitoring costs when assessing the potential impacts of each scenario.     

As mentioned above, small companies operating in the oil refineries, welding and metals sectors would 
be the most affected in terms of compliance costs, as they would have to invest 0.18%, 0.15% and 0.12% 
(one-off  costs),  of  their  turnover  in  new  RMMs  to  comply  with  an  OEL  of  0.05mg/m³,  respectively.  In 
addition  to  these  compliance  costs,  these  companies  would  also  have  to  deal  with  monitoring  costs 
representing 0.02%, 0.081% and 0.108% of their respective turnover over the next 60 years. Overall, the 
impact of both the compliance and monitoring costs may be higher for small companies in comparison 
with medium and large ones, especially as one-off costs will represent more than two thirds of the total 
costs. SMEs could therefore face problems when making the initial investments to comply with the new 
OELs. As requested by the Social Partners in the context of the two-phase consultation, socioeconomic 
considerations should be taken into account when adding or revising OELs. Therefore, the introduction 
of a transition period with a temporary higher initial value could be necessary to enable companies to 
anticipate the changes, gradually introduce improvements and plan the necessary investments.  

The number of companies which might be forced to fully or partially cease activities varies with the level 
of the OEL. The stricter the OEL is, the higher the number of closures would be. At the strictest OEL of 

62 OEL recommended by the ACSH 
63 Transition OEL recommended the ACSH 

27 

 
 
                                                           
0.03 mg/m³, around 90 companies (out of around 60.000) could be forced to close down, among them 
80% would be small companies. The main sector impacted would be oil refineries where 61 companies 
(out of which 51 are  small companies),  representing 6% of the  number of companies operating in this 
sector, could not be able to make the necessary investmets to comply with this OEL. With OELs of 0.05 
mg/m³ and 0.1 mg/m³, this number will be much lower, or even close to zero.  

In  a  letter64  to  the  European  Commission  dated  7  October  2019,  the  Nickel  Institute65  encourages  the 
Commission  to  follow  the  ACSH  recommendation.  Even  if  they  recognised  that  these  values  (both 
inhalable  and  respirable  fractions)  are  stringent  and  can  be  challenging,  they  remain  committed  to 
supporting their implementation. 

As  indicated  in  the  Better  Regulation  Tool  #21,  “all  compliance  costs  divert  resources  from  other 
purposes,  potentially including research and innovation”. Although these compliance  costs represent a 
small  percentage  of  the  overall  turnover,  they  might  still  lead  to  a  decrease  in  the  R&D expenditures. 
This could especially be the case for catalysts and batteries sectors that would need to invest substantial 
amounts  of  money  in  order  to  position  themselves  in  the  Li-ion  battery  value  chain.  However,  the 
companies of both these sectors should face low compliance costs compared to their turnover. 

Looking  beyond  the  EU  borders,  the  majority  of  the  EU  competitor  countries  have  OELs  for  nickel 
compounds  that  are  higher  than  0.05  mg/m³  (including  Australia,  Canada,  Japan  South  Korea,  India, 
Brazil, USA and China for insoluble nickel compounds). The companies located in these countries could 
face  lower  costs  due  to  the  less  strict  measures  to  protect  workers  from  the  exposure  to  nickel 
compounds. Companies which also have plants in non EU countries with less stringent legal provisions 
could be  tempted to relocate some of their operations located in the EU in these countries. However, 
these companies are often large companies for which complying with a new OEL for nickel compounds 
should  be  less  challenging.  Furthemore  and  as  shown  in  the  COWI  study,  the  EU’s  share  in  the  global 
market for nickel metal dropped from more than 30% to less than 20% between 2008 and 2017 for the 
benefit of the Far East and particulary China. This seems to indicate that the level of the EU OEL will not 
be the only driver for the future trends for this global market.   

The impacts on consumers in terms of price should be very limited. Only the metal sector, which would 
face higher compliance costs, could pass on a part of these costs to the price. In the event of companies 
passing on a part of the  increase of their costs to the  prices, this could have  an impact  on consumers 
which could try to buy these products from outside the EU.  

The  introduction  of  an  OEL  is  estimated  not  to  change  the  total  environmental  releases  of  nickel 
compounds  significantly  and  is  estimated  not  to  have  any  significant  environmental  impact.  However, 
two  sectors  in  particular  play  a  considerable  role  in  the  development  of  greener  alternatives  to  fossil 
fuels,  namely  catalysts  and  batteries  industries.  Both  these  sectors  require  considerable  R&D 
investments to satisfy, for example, the growing demand of Li-ion batteries for electric cars. The cost of 

64 Availabe at : https://webgate.ec.testa.eu/Ares/renditionDownload/download.do?itemId=090166e5c8562c8c 
65 The Nickel Institute is the global association of leading primary nickel producers. 

28 

 
 
                                                           
complying  with  new OELs for  nickel  compounds  at  the  levels  below  those  recommended  by  the  ACSH 
(i.e. option 3) might jeopardise this development. 

Setting an OEL of 0.1 mg/m³ and 0.05 mg/m³ would enable to reduce the number of lung cancer cases by 
about 56% and 89% over the next 60 years, the number of pulmonary morbidity cases by about 72% and 
98% and the number of miscarriages by about 57% and 89%, respectively. The setting of any OELs would 
bring marginal benefits to the employers and the public authorities as indicated in the table 9 below. The 
impact  on  other  cancer  endpoints  could  not  be  quantified,  resulting  in  an  underestimation  of  the 
benefits66.  

Only five Member States, namely Bulgaria, Finland, Germany, Poland and Romania, have one single OEL 
for  all  nickel  compounds.  Nine  Member  States  have  no  OEL  at  all:  Cyprus,  Czech  Republic,  Estonia, 
Greece, Italy, Luxembourg, Malta, Portugal and Slovenia. The fourteen remaining Member States have a 
mix of OELs for different nickel compounds, which can complexify the transposition of a single EU OEL for 
nickel compounds in their own legislation. According to the estimates, Member States  with one  single 
already existing OEL for nickel compounds should not face major administrative costs in case they would 
have to revise their own limit value. Member States with an existing mix of OELs would have to invest 
€20,000 to transpose the EU wide single OEL in their own legislation while Member States with no OEL 
would have to incur costs of €50,000. 

Table 9: Multi-criteria analysis on nickel compounds (all impacts over 60 years and additional to the 
baseline) 

Impact 

Stakeholders 
affected 

Option 2 
0.03 mg/m³ 

OEL options - inhalable 

Option 3 
0.05 mg/m³ 
(ACSH) 

Option 4 
0.1 mg/m³ 
(ACSH transitional 
value) 

Companies 

€10 billion 

€4 billion 

€886 million 

Economic impacts 

Compliance costs (one-off and 
recurrent) 

Compliance costs (one-off)* 

Compliance costs (recurrent)* 

Monitoring 

Companies 

Companies 

Companies 

€11 billion 

-€1.1 billion 

€2.5  
billion 

Compliance and monitoring costs 
per company 

Companies 

€197,000 

Administrative costs 

Avoided costs** 

Public sector 

Companies 

€730,000 

€4 
million 

€4.3 billion 

-€165 million 

€2.5  
billion 

€108,000 

€730,000 

€3.9 
million 

€947 million 

-€ 61 million 

€2.5  
billion 

€55,000 

€730,000 

€2.8 
million 

Avoided costs*** 

Public sector  

€2.3 million 

€2.2 million 

€1.5 million 

Single market: competition – No. Of 
company closures 

Companies 

93 

46 

3 

Single-market: consumers 

Internal market**** 

Consumers 

Companies 

Limited impacts expected 

Highest /lowest OEL 
 from 100 to 3 

Highest /lowest OEL 
 from 100 to 5 

Highest /lowest OEL 
 from 100 to 10 

66 Additional information about the analytical challenges leading to potential over- and underestimations is available in Annex 4 

29 

 
 
 
                                                           
International competitiveness 

Companies 

Significantly negative 
for 38% of 
companies***** 

NA 

NA 

Specific MSs/regions – MSs that 
would have to change OELs 

Public sector 

All MS except BG, DE, 
FI, PL, RO 

All MS except BG, DE, FI, 
PL, RO 

All MS except BG, DE, FI, 
PL, RO 

Social impacts 

Reduction in cases – lung cancer 

Reduction in cases (pulmonary 
morbidity) 

Reduction in cases (reproductive 
toxicity) 

Avoided costs of ill health, incl. 
Intangible costs (M1 and M2) 

Employment – Jobs lost 

Employment – Social cost 

Environmental impacts 

Workers & 
families 

Workers & 
families 

Workers & 
families 

Workers & 
families 

Workers & 
families 

Workers & 
families 

147 

712 

88 

133 

702 

80 

84 

517 

51 

€79 – 97 million 

€72 – 92 million 

€47-64 million 

19,000 

€1.6  
billion 

10,000 

€779  
million 

1,500 

€127  
million 

Environmental releases 

All 

No impact/limited impact 

Based on COWI study (2019) 
Notes: All costs/benefits are incremental to the baseline (PV over 60 years) 
* one-off and recurrent costs have been rounded in the COWI study so that the total of these two lines may not correspond to the total 
compliance costs.   
** Including payments related to sick leave, absence from work, insurance premiums 
*** Including heathcare, loss of tax revenue 
****Internal market shows the ratio of highest OEL to lowest OEL before and after implementing the OEL option. 
***** 38% of the companies surveyed in the framework of the COWI study are of the view that the introduction of an OEL of 0.03 mg/m³ 
would have a significant impact on their competitiveness outside the EU. This consultation has not been carried out for the two other 
scenarios.  

6.3.  Benzene 

Baseline 

Approximatively 1,000,000 workers in the EU are exposed to benzene in the sectors that are included in 
this  impact  assessment,  namely  upstream  and  downstream  petroleum  industry,  coking  plants, 
petrochemical industry distribution of petrol, retail and petrol stations, maintenance and repair of motor 
vehicles, foundries, laboratories and other sectors such as paint, adhesive, traffic, fires, etc.  

Benzene is not subject to authorisation according to Annex XIV of REACH. However, according to entry 5 
of Annex XVII of REACH, some uses of benzene are restricted. More information about these restrictions 
is available in annex 10.  

It is assumed for the current disease burden that the number of exposed workers in the relevant sectors 
has been decreasing in the past by 3%67 per year and the exposure concentration have been decreasing 
by 7% per year. These past trends are partly explained by the effects of the introduction of an EU OEL for 

67 For instance, as explained in the COWI study, the number of workers exposed to benzene between 2003 and 2010 in France and between 2005 
and 2014 in Finland has declined by 3.5% per year. 

30 

 
 
 
                                                           
benzene in the CMD in 2004. Annual declines of 2% for the number of workers exposed to benzene and 
0% in exposure concentrations are assumed for the future disease burden. This null trend for the future 
exposure concentrations is based among others on information gathered from the relevant stakeholders 
in the context of the COWI study. The 2% annual decrease is explained by an estimated decrease in the 
use of petrol due to the gradual change to electric vehicles. For the estimates of the current and future 
burdens of disease, a mean latency of 5 years for leukaemia and 0 years for leukocytopenia as well as a 
mortality  rate  of  80%  for  leukaemia  and  0%  for  leukocytopenia  have  been  used.  Without  any medical 
treatment,  leukocytopenia  can  lead  to  weakened  immune  defence  and  increased  risk  of  contracting 
infectious diseases. 

The main cancer effect of benzene is leukaemia, a cancer of the blood system. Benzene also causes other 
hazardous  effects  on  the  bone  marrow.  However,  due  to  lack  of  data,  only  leukocytopenia  has  been 
taken into account in the calculation of the burdens of disease. Other effects such as lymphocytopenia, 
neutrocytopenia and thrombocytopenia could not be quantified and monetised.  

In the absence of any further action, up to 300 cancer cases and 237 leukocytopenia cases are estimated 
to occur in the  coming 60 years. This has been estimated to have  a health cost  between 202 and 331 
million euro.  

Table 10: Baseline scenario over 60 years for benzene 

Types of cancer caused 

Other adverse health effects 

No. of exp. workers 

Change exp. level 

Change no. of exp. workers 

Leukaemia 

Leukocytopenia (quantified), lymphocytopenia, 
neutrocytopenia and thrombocytopenia (not quantifier) 

1,012,500 

Past: -7% 
Future: 0% 

Past: -3% 
Future: -2% 

Current disease burden (CDB) - no. of cancer cases 

30 in 2018 

Future disease burden (FDB) - no. of cancer cases 

FDB - no. of leukocytopenia cases 

Exp. no. of deaths due to FDB cancer 

Exp. no. of deaths due to FDB leukocytopenia  

Monetary value FDB cancer 

Monetary value FDB other adverse health effects 

300 

237 

240 

0 

Method 1: €201 million  
Method 2: €329 million 

Method 1: €1 million 
Method 2: €2 million  

Based on COWI study (2019) 
*Workforce turns over at 5% p.a. 

Impacts of the policy options 

31 

 
 
 
In its opinion on benzene68, RAC derived an OEL of 0.05 ppm (0.16 mg/m³) under which there should be 
no  significant  residual  cancer  risk  or  other  adverse  effects.  It  also  recommends  a  skin  notation  for 
benzene  as  the  dermal  route  can  be  an  important  contributor  to  total  benzene  exposure  in  certain 
situations.   

The table 11 below shows the multi-criteria analysis, summarizing both the monetised impacts as well as 
those that are assessed qualitatively.  

Compliance cost levels for companies generally depend on the extent to which exposures are currently 
close  to  the  required  OELs.  The  higher  the  difference  between  the  current  exposure  levels  and  the 
required OEL is, the higher the investments in RMMs will be. For the purpose of adequately assessing the 
economic  feasibility  for  companies  to  comply  with  the  different  OEL  scenarios,  the  annualised 
compliance costs in percentage of the turnover were calculated.   

Overall, complying with an OEL of 0.05 ppm would cost to the employers 0.17% of their turnover every 
year  over  the  next  60  years.  Companies  operating  in  the  upstream  petroleum  sector,  distribution  and 
foundries  would  be  the  most  impacted  by  facing  higher  compliance  costs  of  about  0.24%,  0.64%  and 
0.29% of the turnover respectively. The average compliance costs related to an OEL of 0.2 ppm69 across 
all the sectors would be of about 0.07 % of the average turnover and relatively higher for the upstream 
petroleum sector (0.08%), as well as the distribution (0.35%).  

For the specific  case of the  foundry  sector, employers would face  relatively higher  one-off compliance 
costs. Companies operating in this sector would have to initially invest 3.41% and 1.1% of their turnover 
to comply with an OEL of 0.05 ppm and 0.2 ppm, respectively. However, as mentioned in annex 3, one-
off  costs  would  represent  one  third  of  the  total  costs  for  companies.  As  requested  by  the  several 
employers  and  workers’  representatives  in  the  context  of  the  two-phase  consultation,  socioeconomic 
considerations  should  be  taken  into  account  when  adding  or  revising  OELs.  The  introduction  of  a 
transition period with a temporary higher initial OEL could enable companies to anticipate the changes, 
gradually  introduce  improvements  and  plan  the  necessary  investments,  softening  in  this  way  the 
economic impact on them.  

As this industry is confronted with global competition, companies will not be able to pass on these costs 
to the users further down the value chain or consumers.  At the strictest OEL, it is likely that companies 
operating in this sector would lose competitiveness, especially compared to China which represent the 
largest  global  suppliers  in  this  sector  (45%  of  the  global  market)  and  where  companies  have  only  to 
comply with an OEL of close to 2 ppm. Any other OELs equal or above the limit value recommended by 
the ACSH should not have any negative impacts on the competitiveness of this industry.  

The  Member  States  with  the  highest  number of  companies  operating with  benzene  across  the  EU  are 
Germany, Italy, France, Poland and Spain. More information about the share of companies by Member 
States in each sector is available in annex 6. 

68 See footnote 25 
69 OEL recommended by the ACSH 

32 

 
 
                                                           
The  setting  of  a  stricter  EU  wide  OEL  for  benzene  will  have  an  impact  on  companies’  cost.  The 
companies’ costs increase arising from the needed investments in RMMs in order to meet a stricter OEL 
could potentially weight negatively on the R&D expenditures. These impacts would depend on the level 
of the OEL and the sector in which the company is active.  

The impact of introducing any of the  envisaged OELs on employment  is very limited. Only the foundry 
industry,  which  could  lose  global  market  shares  at  the  strictest  OEL,  could  be  concerned  by  potential 
consequences on the employment. With regard to the environmental impacts due to the introduction of 
a  stricter  OEL,  it  is  estimated  that  it  would  result  in  positive  impact  due  to  reduced  emissions  to  the 
environment by reducing the fugitive and diffuse emissions from a number of the main sources such as 
upstream and downstream petroleum sectors and the coking sector.  

Setting  an  OEL  of  0.5  ppm70  and  0.2  ppm  would  enable  to  reduce  the  number  of  leukaemia  cases  by 
about  30%  and  60%  over  the  next  60  years  respectively  and  the  number  of  leukocytopenia  cases  by 
about 43% and 80% respectively. Concerning the two other envisaged  scenarios, they would enable to 
reduce  further  the  number  of  leukaemia  and  leukocytopenia,  although  to  a  lesser  extent  than  for  the 
two first scenarios discussed in this paragraph. The setting of any OELs below the current OEL (baseline 
scenario) would bring marginal benefits to the employers and the public sector as indicated in the table 
11  below.  A  number  of  non-cancer  health  endpoints  could  not  be  quantified,  resulting  in  an 
underestimation of the benefits71.      

Although an EU wide OEL already exists for benzene, many Member States would need to revise their 
national OEL whatever the scenario. As indicated in the table 11, all the Member States would need to 
revise their OEL in the event of an EU OEL at the level of option 2. The Member States which would not 
need  to  revise  their  limit  value  for  the  two  other  scenarios  are  referenced  in  the  table  below. 
Considering that all Member States have already an OEL for benzene, the cost of transposing a revised 
OEL would be lower compared to the costs of transposing a new OEL. This cost has been estimated to 
€10,000 per Member State that would have to revise the national OEL.  

Table 11: Multi-criteria analysis on benzene (all impacts over 60 years and additional to the baseline) 

70 Transition OEL recommended by the ACSH 
71 Additional information about the analytical challenges leading to potential over- and underestimations is available at Annex 4 

33 

 
 
                                                           
Impact 

Stakeholders 
affected 

Option 2 

0.05 ppm 

OEL options 

Option 3 

0.2 ppm 
(ACSH) 

Option 4 

0.5 ppm 
(ACSH transitional value) 

Economic impacts 

Compliance costs (one-off 
and recurrent) 

Companies 

€23,526 million 

€7,610 million 

Compliance costs (one-off) 

Companies 

Compliance costs (recurrent) 

Companies 

Annualised compliance costs 
in % of turnover*  

Companies 

Administrative costs 

Public sector 

Avoided costs** 

Avoided costs*** 

Companies 

Public sector  

€11,329 million 

€12,197 million 

0.17% 

€0.3  
million 

€3 million 

€3.8 million 

Single market: competition 

No. of company 
closures 

The foundry sector could 
see closures 

2,461 million 

5,149 million 

0.07% 

€0.3  
million 

€2 million 

€2.5 million 

No closures 

€884  
million 

€740 million 

144 million 

0.01% 

€0.3 
million 

€1 million 

€1.2 million 

No closures 

Single-market: consumers 

Consumers 

Limited impacts expected - small price increase for fuels 

Single market: internal 
market 

Companies 

International 
competitiveness 

Companies 

Specific MSs/regions 

MSs that would 
have to change 
OELs 

Limited impacts expected as the currently even competition between EU companies will 
continue. Only a few Member States (MS) have OELVs lower than current EU value and 
will face lower costs.  

Limited impacts - only 
foundries could face lower 
competitiveness  

No impacts 

No impacts 

All MS 

All MS except NL 

All MS except five 
MS**** 

Social impacts 

Reduction in cases 
(leukaemia cancer) 

Reduction in cases 
(leukocytopenia) 

Avoided costs of ill health, 
incl. intangible costs*****  

Employment 

Environmental impacts 

Workers & families 

 Workers & families 

281 

233 

182 

189 

88 

103 

Workers & families 

€186 - 305 million 

€121 - 198 million 

€59 - 96 million 

Jobs lost 

Social cost 

Few 

No quantification 

0 

€0 

0 

€0 

Environmental releases 

Environment 

Small positive impact of reduced fugitive and diffuse emissions  

Recycling – loss of business 

Recycling 
companies 

No impact expected 

Notes: All costs/benefits are incremental to the baseline (PV over 60 years). 
* Simple average of annualised compliance in % of turnover for all affected sectors 
** Including payments related to sick leave, absence from work, insurance premiums 
*** Including heathcare, loss of tax revenue 
****Denmark, Estonia, Germany and Sweden have an occupational exposure limit (OEL) of 0.5/0.6 and the Netherlands of 0.2. 
***** Values relate to the two methods, method 1 and method 2 

34 

 
 
 
 
 
7.  HOW DO THE OPTIONS COMPARE? 

The main objective is to balance health considerations against economic impacts, by proposing OELs that 
are still economically feasible while protecting a maximum number of workers.   

This impact assessment assessed the different OEL levels without any transitional period. However, the 
ACSH  identified  sectors  that  might  find  it  initially  difficult  to  comply  with  the  OEL  proposed,  and  thus 
suggested  to  include  transitional  periods.  The  duration  of  these  periods  was  established  by  the 
governments,  workers  and  employers,  as  they  have  the  expert  knowledge  about  technological 
development  in  different  sectors.  It  is  assumed  that  these  transitional  periods  are  necessary  for 
companies  to  develop  their  production  processes  to  be  able  to  comply  with  the  OELs  proposed.  They 
should  attenuate  short-term  negative  impacts,  as  the  necessary  investments  in  protective  measures 
would be spread over a longer period of time. 

The aim is therefore  to ensure  a balanced approach and to prevent industries from closures or severe 
disadvantages in particular Member States due to e.g. adopting the most stringent OELs while providing 
an adequate protection of the workers at the EU level.  

The comparison tables used to compare the different options against the baseline scenario in terms of 
effectiveness, efficiency and coherence apply the following ranking symbols:  '0' – baseline, '≈' – similar 
to baseline, '+' more efficient/effective or coherent than baseline; '++' – much more efficient/effective or 
coherent  than  baseline;  '-'  –  less  efficient/effective  or  coherent  than  baseline;  '-  -'  –  much  less 
efficient/effective or coherent than baseline. 

With  regard  to  the  effectiveness,  the  options  are  analysed  among  others  from  the  perspective  of  the 
prevention of deaths and other adverse health effects. 

With regard to the efficiency, the options are analysed among others on the basis of how balanced they 
will  be  between  adequate  protection  of workers  at the  EU  level  and  prevention  of  closures  and other 
severe  disadvantages  for  the  industries.  The  efficiency  is  also  analysed  from  the  perspective  of  the 
costs/benefits  ratios.  However,  although  an  option  has  the  best  costs/benefits  ratio,  it  does  not 
automatically  mean  that  the  protection  it  will  bring  to  workers  will  be  considered  as  sufficiently 
adequate or that the resulting costs for businesses will be disproportionate. 

With regard to the coherence, the options are analysed on the basis of how coherent they are with other 
EU  policies  (including  the  Charter  for  Fundamental  Rights,  the  EU  Pillar  of  Social  Rights,  the  Europe’s 
Beating Cancer Plan and REACH). Coherence with general EU priorities and policies, as well as with the 
Charter of Fundamental Rights,  goes hand in hand with the level of the OELs. The lower the OEL,  the 
more protective for workers’ health. Furthermore, coherence will be also based on to what extent the 
opinion of the ACSH has been taken into account. Indeed, as laid down in the Council decision72 setting 
up  an  ACSH,  this  Committee  “shall  have  the  task  of  assisting  the  Commission  in  the  preparation, 
implementation and evaluation of activities, in the fields of safety and health at work”.  

Acrylonitrile  

72 OJ C 218, 13.9.2003, p. 1-4 

35 

 
 
                                                           
With  regard  to  effectiveness,  options  2  and  3 will  have  the  same  impact  on  prevention of  deaths  and 
other  adverse  health  effects  compared  to  the  baseline  and  the  other  options.  Option  4  brings  less 
benefits compared to options 2 and 3.  

With  regard  to  efficiency,  all  the  options  except  option  1  have  a  costs/benefits  ratio  higher  than  1. 
Option  4  has  the  lowest  costs/benefits  ratio,  followed  by  option  3.  Option  2  has  a  relatively  high 
costs/benefits  ratio  compared  to  the  previous  two. However  and  as  mentioned  in  introduction  of  this 
Chapter, the aim is to ensure a balanced approach between providing an adequate protection of workers 
at  the  EU  level  while  preventing  industries  from  closures  or  severe  disadvantages.  By  recommending 
OELs and transitional measures through scientific, technical and socioeconomic discussion, the tri-partite 
ACSH is probably the best guarantee of such a balanced approach. Therefore, although all the options - 
except  the  baseline  scenario  -  have  costs/benefits  ratios  higher  than  1,  option  3  is  considered  as 
representing the best the balance between the adequate protection of workers and bearable costs for 
the  companies.  Nevertheless,  as  unanimously  agreed  by  the  ACSH,  this  balance  would  require  a 
transition period of 4-years to make sure that companies could make the necessary investments.  

With regard to coherence, establishing an OEL following options 2 and 3 also increases the coherence of 
the CMD with other EU policy objectives, including the Charter for Fundamental Rights, the EU Pillar of 
Social  Rights  and  the  Europe’s  Beating  Cancer  Plan.  It  increases  complementarity  with  REACH,  as 
outlined in section 4. It will also provide legal clarity and a common reference point that can be used as a 
practical  tool  by  employers  (particularly  important  for  SMEs),  workers  and  enforcers  to  assess 
compliance  with  the  general  CMD  requirements,  and  will  also  contribute  to  a  level-playing  field  for 
businesses across the EU (see section 3). For the specific case of acrylonitrile, the strictest OEL (option 2) 
does  not  bring  more  benefits  to  workers  and  their  families  and  to  employers  than  the  ACSH’s 
recommended OEL. Based on the criteria explained above, option 3 is the most coherent as it ensures 
the same coherence with the other EU policies as option 2 while being coherent with the opinion of the 
ACSH.    

Option  3,  with  a  STEL  of  4  mg/m³ (1.8  ppm),  a  skin  notation,  and  with  a  4-years  transitional  period 
starting from the entry into force of the new Directive is therefore the preferred option.  

Table 12: Comparison of options for acrylonitrile (mg/m³) 

Criteria 

Option 1: Baseline 

Effectiveness 
Efficiency 
Coherence 

0 
0 
0 

Nickel compounds 

Option 2: 
0.5 

++ 
-- 
+ 

Option 3: 
1 
(ACSH) 
++ 
+ 
++ 

Option 4: 
2 

+ 
- 
+ 

With  regard  to  the  effectiveness, option  2  and  3  would  enable  to  drastically  reduce  the  risks  of work-
related cancer and non-cancer diseases. Option 4 would result in a substantial reduction of the number 
of lung cancer, pulmonary morbidity and miscarriage cases.  

36 

 
 
 
 
With  regard  to  the  efficiency,  the  costs  outweight  the  benefits  for  all  the  envisaged  options,  except 
option 1. If option 4 has the lowest costs/benefits ratio, costs associated with option 3 are much lower 
than those that would result from adopting option 2. Furthemore, all the Interest Groups in their ACSH 
opinion73 strongly recommended the Commission to adopt a revised OEL, with a preference for option 3. 
This option will ensure a balanced approach between adequate protection of workers at the EU level and 
prevention of closures  and other severe  disadvantages for the industries. However, a transition at the 
level  of  option  4  has  been  considered  as  necessary  to  enable  companies  to  more  swiftly  make  the 
necessary  investments  for  the  purpose  of  reaching  such  a  level  of  workers’  protection.  For  all  these 
reasons, option  3  could  be  seen  as  an medium-term  objective  with  a  transitional  value  at  the  level of 
option 4. Option 2 is considered as less efficient.  

With  regard  to  coherence,  option  2  would  be  the  most    coherent  with  other  EU  policy  objectives, 
including the Charter for Fundamental Rights and the EU Pillar of Social Rights, followed by option 3 and 
option  4.  All  the  options  increase  complementary  with  REACH,  as  outlined  in  section  4.  Taking  into 
account the opinion of the ACSH (option 3 with a transition period at the level of option 4) increases also 
coherence  as  mentioned  in  introduction  of  this  Chapter.  Furthermore,  as  mentioned  in  the  ACSH 
opinion,  nickel  compounds  and  chromium  VI  compounds  are  frequently  occurring  in  the  same  sectors 
and, often, in the same processes. Therefore, aligning the measures for nickel compounds to those for 
chromium VI adopted in the context of the first revision of the CMD and that will apply in January 2025 
would bring more coherence, both in terms of investments for companies and between the updates of 
the CMD. 

Option  3  (0.05  mg/m³  -  inhalable  fraction),  with  a  corresponding  OEL  for  respirable  fraction  of  0.01 
mg/m³,  a  skin  and  respiratory  sensitisation  notation,  and  with  a  transitional  value  until  the  17th 
January 2025 included at the level of option 4 (0.1 mg/m³ - inhalable fraction), is the preferred option.   

Table 13: Comparison of options for nickel compounds (mg/m³ - inhalable fraction) 

Criteria 

Option 1: Baseline 

Effectiveness 
Efficiency 
Coherence 

Benzene 

0 
0 
0 

Option 2: 
0.03 

++ 
-- 
+ 

Option 3: 
0.05 
(ACSH) 

++ 
+ 
++ 

Option 4: 
0.1 
(ACSH transition 
value) 
+ 
+ 
+ 

With  regard  to  the  effectiveness,  option  2  will  have  the  most  positive  impact  on  prevention  of 
occupational  exposure-related  leukaemia  and  leukocytopenia  compared  to  the  baseline  scenario. 

73 In their opinion Doc. 105619, the ACSH strongly recommends the Commission to adopt as soon as possible a revised BOEL for this substance 
under Directive 2004/37/EC. 

37 

 
 
 
 
 
 
                                                           
However,  any  other  envisaged  OELs  would  significantly  reduce  the  number  of  leukaemia  and 
leukocytopenia cases..  

With  regard  to  the  efficiency,  even  if  an  EU-wide  OEL  for  benzene  is  already  set  in  the  CMD,  all  the 
Interest Groups in their ACSH opinion74 strongly recommended the Commission to adopt a revised limit 
value.  Option  3  has  been  considered  as  the  most  balanced  option  between  adequate  protection  of 
workers  at  the  EU  level  and  prevention of  closures  and  other  severe  disadvantages  for  the  industries. 
However, the ACSH considered as important to foresee a transitional value at the level of option 4 from 
2 up to 4 years after the entry into force of the Directive in order to give enough time to the companies 
to  make  the  needed  investments.  Option  4  has  the  lowest  costs/benefits  ratio,  followed  by  option  3. 
Option 2 is the less efficient option with much higher compliance costs than options 3 and 4. All these 
options have a costs/benefits ratio higher than 1.  

With regard to coherence, option 2 will ensure the highest coherence of the CMD with other EU policy 
objectives,  including  the  Charter  for  fundamental  rights  and  the  EU  pillar  of  Social  Rights,  followed  by 
option  3  and  option  4.  All  the  options  increase  complementary  with  REACH,  as  outlined  in  section  4.  
Coherence also depends on to what extent the opinion of the ACSH is taken into account, as explained in 
introduction of this Chapter., The ACSH agreed on an OEL at the level of option 3 as well as a transitional 
value at the level of option 4 which would enable companies to make the necessary investments. 

Option 3, with transitional value at the level of option 4 from two up to four years starting from the 
entry  into  force  of  the  new  Directive  and  the  confirmation  of  the  skin  notation,  is  therefore  the 
preferred option.  

Table 14: comparison of options for benzene (ppm) 

Criteria 

Option 1: Baseline 

Effectiveness 
Efficiency 
Coherence 

0 
0 
0 

Option 2: 
0.05 

++ 
-- 
+ 

Option 3: 
0.2 
(ACSH) 

+ 
+ 
++ 

Option 4: 
0.5 
(ACSH transition 
value) 
+ 
+ 
+ 

8.  PREFERRED OPTIONS 

8.1. 

Summary of the preferred options 

It  has  been  shown  in  the  previous  sections  that  the  impacts  of  the  considered  measures  for  the 
protection  of  workers  vary  significantly  for  the  different  substances  assessed  in  this  report.The  table 
below summarises the preferred options.  

74 In their opinion Doc. 105619, the ACSH strongly recommends the Commission to adopt as soon as possible a revised BOEL for this substance 
under Directive 2004/37/EC. 

38 

 
 
 
 
 
                                                           
Table 15: Summary of the preferred options, by assessment criteria 

Name of chemical agent 

Retained option  
OEL (8h-TWA) and notation 

Acrylonitrile 

Nickel compounds  

Benzene  

8TWA: 1 mg/m³ (0.45 ppm) 
(4 years transition period*) 
STEL: 4 mg/m³ (1.8 ppm) 
(4 years transition period*) 
-------------------------------- 
Skin 
0.01 mg/m³ (respirable fraction)** 
0.05 mg/m³ (inhalable fraction)** 
0.1 mg/m³ (inhalable fraction – transition period until 17th January 2025 included) 
-------------------------------- 
Skin and respiratory sensitisation 
0.2 ppm 
(4 years transition period*) 
0.5 ppm 
(From 2 years up to 4 years after entry into force of the Directive amending the CMD) 
-------------------------------- 
Skin 

*From the date of entry into force of the Directive amending the CMD  
**The limit values for the respirable and inhalable fractions shall apply from 18th January 2025. Until then, a limit 
value for the inhalable fraction of 0.1 mg/m³ shall apply while no limit value for the respirable fraction shall apply. 

8.2.  Overall impact of the package or preferred options 

Although the recent coronavirus pandemic is expected to have substantial socioeconomic consequences, 
it is still too early to assess with any degree of certitude the magnitude of these impacts on the business, 
especially  at  the  sectoral  level.  According  to  International  Monetary  Fund’s  (IMF)  World  Economic 
Outlook of April 202075, the EU-27 Gross Domestic Product  (GDP)  growth could decrease  from 7.1% in 
2020  compared  to  2019  and  could  rebound  to  4.7%  in  2021.  However,  IMF  mentions  that  “there  is 
considerable  uncertainty  about  what  the  economic  landscape  will  look  like  when  we  emerge  from  this 
lockdown”. Given the large degree of uncertainty, these impacts have not been included in the impact 
analysis below.     

8.2.1.  Impact on workers 

The retained option package for the three substances or groups of substances considered in this impact 
assessment  (henceforth  “the  preferred  option”)  should  result  in  benefits  in  terms  of  avoided  work-
related  cases  of  cancer  and  other  serious  illness,  and  related  monetised  health  benefits  including 
avoidance of intangible costs such as the reduced quality of life, the suffering of the workers and their 
family, the pain, etc. 

75 https://www.imf.org/external/pubs/ft/weo/2020/01/weodata/index.aspx 

39 

 
 
 
                                                           
This impact assessment is limited to assessing the most sensitive cancer endpoint and the most sensitive 
other adverse health effects for each substance. Nevertheless, the chemical agents under consideration 
pose a range of other occupational hazards for which the available data is not sufficient to estimate the 
magnitude  of  the  global  related  benefits  for  workers.  As  a  result,  and  taking  into  account  general 
estimates of costs related to these diseases, benefits for workers and society are likely underestimated.  

The greatest assessable benefits are expected in relation to nickel compounds and benzene. The retained 
option would indeed result in:  

  Acrylonitrile: up to 12 brain cancer cases, 408 nasal irritation cases prevented and a monetised 

health benefit of €440,000-€5,800,000. 

  Nickel compounds: 133 lung cancer cases, 702 pulmonary morbidity cases and 80 miscarriage 

cases prevented, and a monetised health benefit of €72-92 million. 

  Benzene: 182 cases of leukaemia and 189 cases of leukocytopenia prevented, and a monetised 

health benefit of €121-198 million.  

The costs and benefits resulting from the combination of several OELs for one substance have not been 
assessed in the COWI study. For that reason, the benefits mentioned above are those calculated for the 
preferred  option  for  each  substance  without  any  transition  measures.  However,  it  is  reasonable  to 
consider  that  accompanying  an  OEL  with  transitional  measures  would  have  limited  impacts  on  the 
benefits  and  relatively  higher  impacts  on  costs.  It  is  all  the  more  true  that  the  duration  of  these 
transitional measures will be limited and it is likely that some companies have already started to make 
the necessary investments in anticipation of the new or more stringent OELs to come.  

8.2.2.  Impact on business 

As  regards  costs  incurred  by  enterprises  for  risk  reduction  measures,  the  preferred  option  will  affect 
operating  costs  for  companies  which  will  have  to  put  in  place  additional  protective  and  preventive 
measures.  This  will  be  particularly  the  case  for  nickel  compounds  and  benzene,  where  the  total  costs 
(compliance  and  monitoring  costs)  to  industry  of  the  retained  option  over  the  next  60  years  are 
estimated  to  be  about  €6.5  billion  and  €7.61  billion  respectively.  Companies  dealing  with  nickel 
compounds could indeed face additional monitoring costs for measuring the respirable fraction, which is 
not  the  case  at  the  moment.  However,  these  figures  have  to  be  put  into  perspective.  Concerning 
benzene, companies, irrespective of their size or sector, will need to dedicate 0.07% of their annualised 
turnover each year. With regards to nickel compounds, it is estimated that the total costs per company 
will be of €108,000 over 60 years. In addition to that, in a letter76 to the European Commission dated 7 
October  2019,  the  Nickel  Institute  encourages  the  Commission  to  follow  the  ACSH  recommendation. 
Even  if  the  Nickel  Institute  recognizes  that  the  ACSH  recommended  values  are  stringent  and  can  be 
challenging,  they  remain  committed  to  support  their  implementation  by  the  time  provided  by  the 
legislation. For these reasons, the cost per company in relative terms for both substances is expected to 
be  sustainable,  although  some  SMEs  concerned  by  the  use  of  nickel  compounds  might  face  more 

76 See footnote 64 

40 

 
 
 
                                                           
difficulties to comply with the preferred option as discussed in the section dedicated to the impact on 
SMEs.  In  addition  to  that,  transitional  measures  are  foreseen  for  acrylonitrile,  benzene  and  nickel 
compounds so that companies would have more time to make the necessary investments while already 
improving the protection of workers. Indeed, although the annualised cost per company is expected to 
be sustainable, most investments in RMMs would take place early in the 60 year period considered in the 
calculations. For the specific case of nickel compounds, the transition period that ends in January 2025 
will  ensure  alignment  with  the  measures  adopted  for  chromium  VI,  since  both  group  of  substances 
(nickel  compounds  and  chromium  VI  compounds)  are  frequently  occurring  in  the  same  sectors  and, 
often,  in  the  same  processes.  As  unanimously  recommended  by  the  ACSH77,  reducing  the  exposure  to 
nickel compounds and chromium VI compounds must be coordinated and can benefit from synergies.  

As discussed in section 6.3, in the case of benzene, companies operating in the foundry sector will face 
relatively  higher  one-off  compliance  costs  compared  to  their  turnover  than  in  the  other  sectors.  As 
shown in table 70 in annex 6, these companies are mainly located in Italy (18,7% of all the EU foundries), 
Germany (13,6%) and Czech Republic (12,9%).  

Impact on SMEs     

For nickel compounds and benzene, SMEs represent a large proportion of the relevant industries while 
companies using acrylonitrile are mainly large companies. For the specific case of nickel compounds, 95% 
of the companies are even small companies. Therefore, SMEs specificities, their limitations and particular 
challenges have been duly taken into account in the overall analysis presented in section 6.  

Many of the RMMs required to meet the OELs involve capital expenditure, and SMEs might face higher 
cost of finance compared to large companies. However, the analysis has shown that in most cases, costs 
which  will  be  incurred  by  SMEs  dealing  with  acrylonitrile  and  benzene  are  not  significant.  Some  SMEs 
concerned by the use of nickel compounds and operating in the oil refineries, welding and metals sectors 
might face more difficulties to comply with the preferred option. As shown in table 60 in annex 6, more 
than 1,000 companies dealing with nickel compounds in these three sectors are small companies while 
200  are  medium  companies.  Therefore,  transition  periods  with  higher  initial  values  are  necessary  to 
ensure that it is possible for companies to anticipate the changes, gradually introduce improvements and 
plan the necessary investments.  

Moreover, introduction of an OEL will only have a significant impact on companies which have not yet 
made  the  investments  to  protect  workers  either  through  closed  systems  or  substitution  of  the 
substances where technically feasible.  

Impact on competition and competitiveness 

The  preferred  option  would  have  a  positive  impact  on  competition  within  the  internal  market  by 
decreasing  competitive  differences  between  firms  operating  in  Member  States  with  different  national 
OELs and providing greater certainty concerning enforceable exposure limit across the EU. Regarding the 

77 The links to these ACSH opinions are available at the Annex II 

41 

 
 
                                                           
specific case of nickel compounds, the capital expenditures required for start-ups to ensure compliance 
with the EU OELs could make their entry into the market more difficult. 

Even  if  the  retained  option  has  often  more  stringent  OELs  compared  to  the  European  Union’s  main 
competitor countries, it should not have a significant impact on the external competitiveness of EU firms. 
The detailed assessment  provided above  shows  indeed that in most  cases additional compliance  costs 
per firm are not significant  although some SMEs operating in the oil refineries sector might  face more 
difficulties to comply with the preferred option, as discussed above.  

It has however to be noted that the foundry sector dealing with benzene, which will face relatively high 
one-off  compliance  costs  with  the  retained  option  and  operates  in  a  global  market,  could  face  more 
difficulties. The European foundry sector currently holds a global market share around 10-15% and has to 
compete with China (which holds 45% of the global market), India and the USA. While India and the USA 
have OELs that are lower than or similar to the current EU OEL of 1 ppm78,  in China, companies have to 
comply  with  an  OEL  of  1.9  ppm.  European  companies  in  this  sector  could  therefore  face  a  greater 
competition  due  to  the  retained  option.  However,  these  possible  impacts  could  not  be  estimated. 
Moreover, the preferred option has a transition period which will give more time to the companies to 
adjust to these changes.  

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

8.2.3.  Impact on environment 

The impact of the package of the preferred options on environment depends on the substances. Setting 
an  EU-wide  OEL  for  acrylonitrile  and  nickel  compounds  will  not  lead  to  higher  releases  in  the 
environment and have therefore no impact. With regard to benzene, lowering the existing OEL at the EU 
level will even reduce the fugitive or diffuse emissions in some sectors as explained in section 6. Revising 
the limit value at the level of the preferred option for benzene would therefore have positive impacts on 
the  environment.  The  introduction  of  the  preferred  option  for  acrylonitrile  will  not  lead  to  further 
installation  of  LEVs  that  might  lead  to  increased  emissions  in  the  air.  None  of  the  potential  RMMs  to 
comply  with  the  preferred  option  for  acrylonitrile  are  expected  to  lead  to  significant  changes  in  the 
releases of acrylonitrile to water. The introduction of the preferred option for nickel compounds should 
not significantly change the total environmental releases of nickel compounds.  

In addition to the direct impacts on environment, the introduction of an OEL could also lead to indirect 
impacts.  As mentioned  in section  6,  nickel  compounds  play  a considerable  role  in  the  development  of 

78 India = 0.5ppm / USA (OSHA) = 1 ppm  

42 

 
 
                                                           
greener  alternative  to  fossil  fuels.  The  Nickel  institute  considers  that  the  need  for  nickel  and  its 
compounds will keep growing as they support “the development of solutions and innovations to address 
some  of  the  most  pressing  challenges,  such  as  energy  storage  and  supply,  sustainable,  recyclable 
products and green transport”79. The compliance costs arising from lowering the OEL to the level of the 
preferred option should however not have any impacts on the innovative capacity of the sectors using 
nickel compounds to develop these solutions and innovations.  

While  an  EU  OEL  for  acrylonitrile  should  not  lead  to  higher  releases  in  the  environment  and  have 
therefore  no  significant  impact,  the  acrylonitrile  industry  also  has a  role  to  play  in  developing  greener 
technologies for some sectors. It is however difficult to say at this stage whether this positive impact will 
is  widely  used  to  produce  high  performance 
be  significant.  For  example,  this  substance 
elastomers/rubbers,  structural  resins  and  plastics,  which  are  essential  for  the  automotive  sector’s 
transition  to  lightweight,  fuel  efficient  and  electric  vehicles80.  Acrylonitrile  is  also  essential  to  produce 
water  purification  coagulants81  and  is  key  to  produce  carbon  fibres  used  in  wind  turbine  blades’ 
manufacturing.  

8.2.4.  Impact on Member States/national authorities 

Member States with established OELs at the level of the retained option will be less affected than those 
having higher or no OEL in place. Each multi-criteria analysis above lists,  for each option, the Member 
States  that  will  have  to  enforce  a  stricter  OEL.  More  details  and  national  OELs  for  all  substances  are 
provided  in  annex 5.  The  preferred option  should  contribute,  although  not  significantly,  to  reduce  the 
costs  related  to  occupational  diseases  for  social  security  systems.  Additional  administrative  and 
enforcement  costs  might  be  incurred  by  enforcing  authorities.  These  costs  are  not  quantifiable  as  the 
granularity  of  Member  States'  reporting  of  enforcement  activity  is  not  sufficient  to  distinguish  costs 
related to a particular OEL.  

However, it is not expected for the costs to be significant. OEL enforcement will take place according to 
already  existing  mechanisms  for  compliance  improvement  and  enforcement,  including  informal 
conversations with employers as well as formal correspondence and legal enforcement action.  

Usually,  national  inspectors  organise  visits  in  companies  to  ensure  the  employers’  compliance  with 
several OSH provisions (for example, workplace transport, slips and trips, machinery safety, stress) rather 
than only checking the conformity with the OELs. Specific reporting would only be the case where Labour 
Inspectorates  undertake  targeted  chemical  carcinogen  enforcement  activity  and  OEL  campaigns.  Costs 
will therefore be  generally affected by Labour Inspectorate  resourcing, prioritisation and targeting. No 
assumption  may  be  made  that  enforcement,  a  Member  State  competence,  will  receive  (or  demand) 
greater resourcing and priority as a result of an OEL being set.   

79 Nickel Institute (2015), Nickel compounds – the inside story….  
Available at: http://nickel-japan.com/magazine/pdf/NickelStory_EN.pdf 
80 Petrochemicals Europe, Uses and Propreties. Available at : https://www.petrochemistry.eu/sector-group/acrylonitrile/ 
81 See footnote 18 

43 

 
 
                                                           
At the same time, establishing OELs, and other explicit references to a given substance in the CMD brings 
clarity regarding legal requirements, and so facilitates the work of inspectors by providing a helpful tool 
for compliance checks. Setting OELs at EU level would also limit the need for national administrations to 
carry out the costly and burdensome necessary work for establishing those limit values at national level. 

8.2.5.  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). 

8.2.6.  Subsidiarity, proportionality and REFIT 

In  view  of  the  available  scientific  evidence  it  is  necessary  to  establish  both  new  OELs  for  a  number  of 
substances  for  inhalation  exposures  and  information  on  other  routes  of  exposure  (e.g.  dermal)  which 
could  contribute  significantly  to  the  overall  body  burden  of  the  workers.  The  protection  of  workers 
health  against  risks  arising  from  exposure  to  carcinogens  is  already  covered  by  EU  legislation,  in 
particular  by  Directive  2004/37/EC  (CMD),  which  can  be  amended  at  EU  level  after  a  two-stage 
consultation  of  the  social  partners.  The  preferred  option  takes  into  account  long  and  intensive 
discussions  with  all  stakeholders  (representatives  from  workers’  associations,  representatives  from 
employers'  associations,  and  representatives 
including  consideration  of 
socioeconomic feasibility.   

from  governments), 

Updating  the  CMD  to  take  account  of  newer  scientific  evidence  is  an  effective  way  to  ensure  that 
preventive measures  would be  updated accordingly  in all Member States, providing a uniform level of 
minimum requirements designed to guarantee a better standard of health and safety. Action taken by 
individual  Member  States  in  response  to  available  technical  data  would  risk  increasing  divergences 
between Member States with potential competition on the basis of OELs set at different levels. Business 
would therefore continue to compete on an uneven playing field, which would hamper the operation of 
the internal market. Updating the CMD therefore complies with the principle of subsidiarity. 

The proportionality principle is fully respected as the preferred option is limited to setting out the limit 
values for three additional agents by amending Annex III to the Directive on the basis of the scientific and 
technical  data  available,  as  provided  by  Article  16  (1)  of  the  CMD.  This  initiative  aims  to  make  a  step 
forward to achieve the objectives set to improve living and working conditions of workers. 

With regard to the preferred option, socio-economic and feasibility factors have been taken into account 
after  intensive  discussions  with  all  stakeholders  within  the  ACSH  (representatives  of  workers’ 
organisations, representatives of employers’ organisations, and representatives of governments). It also 
includes measures for mitigating burdens and supporting compliance (including transition periods) which 
have  also  been  discussed  by  the  relevant  stakeholders.  These  transitional  measures  contribute  to  the 
proportionality of the preferred options by ensuring a more appropriate temporal margin for businesses 
to adapt.  

44 

 
 
As shown above, the costs outweight the quantified benefits for all the preferred options. However, the 
selection of the most  appropriate option cannot  be done  merely on the basis of a costs/benefits  ratio 
comparison. Indeed, the main general objective of this initiative is to ensure to the workers the right to a 
high  level  of  protection  of  their  health  and  safety  at  work.  This  objective  is  in  line  with  the  European 
pillar  of  Social  Rights,  which  enshrines  workers’  right  to  healthy,  safe  and  well-adapted  work 
environment, and with the upcoming Europe’s Beating Cancer Plan. As mentioned in Chapter 7, the aim 
of  this  initiative  is  to  ensure  a  balanced  approach,  i.e.  to  prevent  industries  from  closures  or  severe 
economic  disadvantages  while  providing  an  adequate  protection  of  the  workers  at  the  EU  level.  The 
preferred options are considered balanced and justified in light of the accrued and longer-term benefits 
in terms of reducing health risks arising from workers' exposure to carcinogens and saving lives. Despite 
their  high  costs,  the  preferred  options  have  the  support  of  the  key  stakeholders  in  the  area  of  OSH, 
namely  the  employers,  employees  and  national  governments  representend  within  the  ACSH.    It  also 
needs to be noted that, when considering the costs per company and, in particular when comparing the 
expected costs to the turnover of the average company, the estimated burden is overall sustainable. 

Furthermore,  the  preferred  options  also  offer  a  certain  margin  of  flexibility  to  Member  States.  In 
accordance with Article 153(4) of the TFEU, setting OELs at the EU level does not prevent Member States 
from maintaining or introducing more stringent protective measures (i.e. lower limit values). However, 
Member States cannot set higher limit values than the EU OELs set in the Annex III of the CMD.  

Finally,  regarding  the  simplification  and  the  efficiency  improvement  of  the  existing  legislation,  the 
preferred  option  eliminates  the  need  for  Member  States  to  conduct  their  own  scientific  analysis  to 
establish OELs for the three substances and brings clarity regarding the  acceptable levels of exposure, 
facilitating  the  work  of  inspectors  by  providing  a  helpful  tool  for  compliance  checks.  Employers  also 
benefit  from  the  simplification  in  ensuring  legal  compliance,  particularly  those  operating  in  different 
Member States. 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

9.1.  Monitoring arrangements 

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

Table 16: Indicators and monitoring arrangements/data sources 

Operational 
objective 

Indicators 

Monitoring arrangements/data sources for monitoring 
indicators 

45 

 
 
The reduction of 
occupational 
diseases and 
occupational related 
cancer cases in the 
EU 

The number of 
occupational 
diseases and 
occupational related 
cancer cases in the 
EU 

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 other non-
cancer work-related health problems and illnesses in 
accordance with Regulation (EC) No 1338/200882.  
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 the OSH acquis, 
submitted in accordance with Art. 17a of Directive 
89/391/EEC. 

- 

- 

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

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

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). 

A  two-stage  compliance  assessment  (transposition  and  conformity  checks)  will  be  carried  out  by  the 
Commission  for  the  transposition  of  the  limit  values.  At  workplace  level,  there  is  an  obligation  for 
employers  to  ensure  that  the  exposure  does  not  go  above  the  limit  values  set  out  in  Annex  III  to  the 
Directive. The monitoring of application and enforcement will be undertaken by national authorities, in 
particular  the  national  labour  inspectorates.  At  EU  level,  the  Committee  of  Senior  Labour  Inspectors 
(SLIC) informs the Commission regarding problems relating to the enforcement of Directive 2004/37/EC.  

While  collection  of  reliable  data  in  this  area  is  complex,  the  Commission  and  EU-OSHA  are  actively 
working on improving data quality and availability so that the actual impacts of the proposed initiative 
could be measured in a more accurate way and additional indicators could be developed in the future 
(e.g. in relation to mortality caused by occupational cancer). Ongoing projects include cooperation with 
national authorities on the European Occupational Diseases Statistics (EODS) data collection.   

Legislative  action  needs  to  be  followed  up  through  effective  implementation  at  the  workplace.  In  this 
context,  EU-OSHA  has  carried  out  a  Healthy  Workplaces  Campaign  on  dangerous  substances  in  2018-
2019 pursuing several objectives, including raising awareness of the importance of preventing risks from 
dangerous  substances,  promoting  risk  assessment,  heightening  awareness  of  risks  to  exposure  to 
carcinogens at work or increasing knowledge of the legislative framework. Under the framework of this 

82 Regulation (EC) No 1338/2008 on Community statistics on public health and health and safety at work, OJ L 354/70, 31.12.2008 

46 

 
 
 
                                                           
campaign,  EU-OSHA  has  provided  a  broad  range  of  tools,  information  and  good  practices  that  will 
support the implementation of this Directive.  

9.2.  Evaluation arrangements 

In accordance with Article 17a of Directive 89/391/EEC, every five years, Member States are required to 
submit a report to the Commission on the practical implementation of the EU OSH Directives, including 
Directive  2004/37/EC.  Using  these  reports  as  a  basis,  the  Commission  is  required  to  evaluate  the 
implementation  of  Directive  2004/37/EC  and,  to  inform  the  European  Parliament,  the  Council,  the 
European Economic and Social Committee and the Advisory Committee on Safety and Health at Work of 
the  results  of  this  evaluation  and,  if  necessary,  of  any  initiatives  to  improve  the  operation  of  the 
regulatory framework.  

Given the data challenges explained earlier, it is suggested to make use of the next relevant evaluation 
exercise,  after the  end of the  transposition period, to define the baseline values  (benchmark) that will 
allow  assessing  the  effectiveness  of  further  amendments  of  the  CMD.  Evaluation  of  the  practical 
implementation of  the  proposed  amendments  could  possibly  be  based  on  the  following  period  (2023-
2027). 

47 

 
 
 
 
Annex 1: Procedural information 

1.  LEAD DG, DeCIDE PLANNING/CWP REFERENCES 

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

2.  ORGANISATION AND TIMING 

A first consultation of the Occupational Safety and Health Inter-services Steering Group (OSH ISG) on the 
draft Impact Assessment Report (IAR) was launched on 27 February 2020 with a deadline for comments 
on Friday 20 March 2020. Twelve services (SG, SJ, BUDG, GROW, ENER, ENV, RTD, CNECT, EAC, SANTE, 
JUST, ESTAT) as well as EU-OSHA have been consulted. Most of the comments provided by the services 
have been addressed in the revised draft IAR. A table summarising the key comments and the way DG 
EMPL addressed them in the revised IAR was circulated. 

A second consultation of the OSH ISG on the revised draft IAR was launched on 30 March 2020 with a 
deadline  for  comments  on  Tuesday  14  April  2020.  This  second  consultation  was  carried  out  with  the 
same services than for the first consultation. DG EMPL took most of these comments into consideration 
in the revised version of the draft IAR. This revised version of the draft IAR was sent to the Regulatory 
Scrutiny Board (RSB) on 24 April 2020.  

3.  CONSULTATION OF THE RSB 

The RSB opinions for the first three CMD amendments have been taken into account when carrying out 
this Impact Assessment. The draft IAR for this initiative was submitted to the RSB on 24 April 2020 and 
the meeting with the RSB has taken place on 27 May 2020. Following this meeting, the RSB gave a 
positive opinion with reservations.  

The table below summarises the RSB comments as well as the revisions introduced in response to them:  

RSB opinion’s comments 
The report is not sufficiently clear how the 
situation would evolve without exposure limits 
(baseline scenario). It does not factor in trends in 
actual exposure and the impacts of the Directive’s 
requirement that employers minimise workers’ 
exposure.  
(comments B1 and C2) 

Corresponding changes to the draft IAR 
Section 2.3. has been further developed to explain 
that assumptions made to asses how will the 
problem evolve are based both on the legal 
provisions contained in the CMD (including the 
minimisation requirements) and on other data 
including information gathered from stakeholders. 
This has also been specified in the “analytical 
methodology” section of Chapter 6. 

Further explanations aiming to underpin the 
choice of the assumptions for the trends in terms 
of exposure levels for the three substances have 
been added in Chapter 6 (as well as in Annex 6 for 
the specific case of nickel compounds).  

48 

 
 
 
The report does not sufficiently analyse the 
impacts of the various transitional periods, which 
it introduces only at the stage of comparing 
options. The report should justify the choice of 
durations and starting points of the proposed 
transitional periods for each substance when 
describing the options. It should clarify whether it 
proposes transitional periods to synchronise with 
equipment renewal cycles.  
(Comments B2 and C4) 

The report does not sufficiently explain the criteria 
for selecting the preferred options. The relative 
weight of consultative processes vs. cost benefit 
analysis is not clear.  
(Comments B3 and C6) 

The report does not sufficiently assess the 
proportionality of the preferred options.  
(Comments B4 and C7) 

Section 5.2 further explains why it was not 
possible to assess the combination of several OELs 
introduced by the use of transitional periods (as 
recommended by the ACSH) as policy options. 
These combinations have been recommended by 
the ACSH while the COWI study was already at an 
advanced stage so that it was not possible 
anymore to asses their costs and benefits. 
However, this section also specifies that all the 
transitional OELs are covered by the assessed 
policy options. Although the costs and benefits of 
the combination of OELs are not available, a 
paragraph has been added in section 8.2 to explain 
that they should have limited impacts on the 
benefits and relatively higher impacts on costs.  

Chapter 7 further explains the choice of the 
transition measures for all the substances, when 
comparing the policy options.  

With regard to the specific case of nickel 
compounds, a paragraph has been added in 
Chapter 7 to explain how coherent it would be to 
align (synchronise) the transitional measures for 
this substance to those agreed for chromim VI in 
the context of the first revision of the CMD.  

Chapters 6 and 8 further describe the need for a 
transition period for acrylonitrile.  
A part of the section 1 has been edited to further 
explain the broad consultation that has been 
conducted to prioritise the three substances. 

Chapter 7 has been revised to further explain on 
the basis of which critera the efficiency, 
effectiveness and coherence of the policy options 
have been assessed. The paragraph dedicated to 
the efficiency further explained how both the 
consultative process and costs/benefits analysis 
are taken into consideration.     
The paragraphs in Chapter 8 dedicated to the 
proportionality have been further improved, 
including by explaining the role of the tri-partite 
stakeholders when considering limit values that 
would ensure a balanced and adequate protection 
of the workers at the EU level and how this 
contribute to have proportionate preferred 
options.  

49 

 
 
 
 
 
 
The report could explain how the Occupational 
Safety and Health evaluation and the conclusions 
of the REACH REFIT evaluation have fed into this 
impact assessment. Where relevant, it should 
explicitly refer to evaluation findings in the 
problem definition.   
(Comment C1) 
The report should clearly distinguish between the 
problems for Acrylonitrile and Nickel compounds 
(for which EU OELs do not exist) and Benzene 
(which has an EU OEL). For benzene, the report 
should better explain how the existing OEL has 
worked and why there is a need to revise it. 
Similarly, the report should distinguish arguments 
on subsidiarity that apply to the new OELs 
(acrylonitrile, nickel compounds) and revised ones 
(benzene).   
(Comment C3) 
The cost analysis should better reflect what 
investments are regular equipment renewal, 
which is part of the baseline, as opposed to 
additional investment to comply with the new 
OELs. 
Comment (C5) 

Some paragraphs have been added in section 1 to 
explain to what extent these evaluations go hand 
in hand with this initiative and this IAR. 

Section 2.2 has been edited to explain what did 
the existing EU OEL for benzene bring compared to 
a scenario with no existing EU OEL.  

Section 3.2 further distinguishes the necessity and 
added value of EU action for acrylonitrile and 
nickel compounds (substances without any EU 
OEL) and benzene (substance with an existing EU 
OEL).  

Two lines have been added in tables 7, 9 and 11 to 
split in two the compliance costs: one-off and 
recurrent compliance costs. Furthermore, the 
section “impacts of the policy options” dedicated 
to acrylonitrile has been edited to better refer to 
this distinction between one-off and recurrent 
costs.  

A footnote has been added in tables 7 and 9 to 
clarify that one-off and recurrent costs have been 
rounded in the COWI study so that the total of 
these two lines may not correspond to the total 
compliance costs.   

4.  EVIDENCE, SOURCES AND QUALITY 

Risk Assessment Committee’s Opinions 

The  assessment  of  health  effects  of  the  carcinogens  subject  to  this  proposal  is  based  on  the  relevant 
scientific expertise from ECHA’s Committee for Risk Assessment (RAC). 

RAC prepares the opinions of the European Chemicals Agency (ECHA) related to the risks of substances 
to  human  health  and  the  environment.  RAC  examines  among  others  the  proposals  for  harmonised 
classification and labelling, evaluates whether the proposed restriction on manufacture, placing on the 
market or use of a substance is appropriate in reducing the risk to human health and the environment, 
and assesses the applications for authorisation of chemicals. Moreover, opinions from RAC also support 

50 

 
 
 
 
 
Union regulatory activity in the field of occupational safety and health. More information about what this 
committee does can be found on the website of ECHA83. 

RAC  develops  high  quality  comparative  analytical  knowledge  and  ensures  that  Commission  proposals, 
decisions and policy relating to the protection of workers’ health and safety are based on sound scientific 
evidence.  Based  on  a  Service  Level  Agreement  (SLA)  signed  by  DG  EMPL  and  ECHA,  this  Committee 
assists  the  Commission  delivering  scientific  evaluations,  upon  request,  on  the  toxicological  profiles  of 
each of the selected priority chemical substances in relation to their adverse health effects on workers. 
These scientific evaluations shall, where appropriate, include proposals for Occupational Exposure Limit 
values  (OELs),  biological  limit  values/biological  guidance  values  and/or  notations.  Based  on  such 
opinions, the Commission will propose 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 RAC are highly qualified, specialized, independent experts selected on the basis of objective 
criteria.  They  provide  the  Commission  with  Recommendations  and  Opinions  that  are  helpful  for  the 
development of EU policy on workers protection.  

For the purpose of this initiative, the Commission services have used the relevant chemical agent-related 
RAC opinions which are summarised in the following table:  

Chemical 

Acrylonitrile85 

Nickel and its 
compounds86 
Benzene88 

Table 17: Summary of the RAC opinions 

8 hrs TWA84 

STEL 15’ 

Notations 

1 mg/m³ (0.45 ppm) 

4 mg/m³ (1.8 ppm) 

Skin 

0.005 mg/m³87 
0.03 mg/m³  
0.05 ppm (0.16 mg/m³) 

none 

none 

Sensitisation 

Skin 

Studies performed by external consultants 

The Commission launched a call for tender on 9 May 2018 an open call for tender89 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  a  certain 
number of substances at the workplace, including acrylonitrile, nickel compounds and benzene.  

83 https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment 
84 Inhalable fraction unless otherwise specified 
85 See footnote 23 
86 See footnote 24 
87 Respirable fraction 
88 See footnote 25 
89 Call for Tender documents available at: https://etendering.ted.europa.eu/cft/cft-display.html?cftId=3559 

51 

 
 
 
                                                           
The contract started on 3 September 2018 and lasted 11 months. The outcome of this study provides the 
main basis for this Staff Working Document and is summarised in the relevant sections of this document. 

52 

 
 
 
 
Annex 2: Stakeholder consultation  

The following consultation activites have been performed :  

1.  Social  Partners  Consultation:  as  requested  by  the  TFEU  Article  154,  a  formal  two-stage 
consultation  of  the  social  partners  at  EU  level  is  required  prior  to  submitting  proposals  in  the 
social policy field. Such a two-stage consultation has been performed in 2017. The first phase of 
social  partners’  consultation  closed  on  30  September  2017  where  3  substances  have  been 
identified  for  this  initiative.  The  second  phase  consultation  closed  on  22  December  2017  and 
confirmed these 3 substances as to be addressed in this initiative. More information about these 
two-stage consultation is provided below in this annex 2. 

2.  Tripartite  consultation  (ACSH):  the  tripartite  Advisory  Committee on  Safety  and  Health  (ACSH), 
composed  of  three  full  members  per  Member  State,  representing  national  governments, 
workers' and employers' organisations, is consulted on regular basis. It gives, taking into account 
the input of the RAC as well as socio-economic and feasibility factors, opinions which are used to 
prepare  the  Commission's  proposal.  More  information  about  this  tripartite  consultation  is 
provided below in this annex 2.  

3.  Consultation  of  other  stakeholders  (e.g. 

industry  of  employees  associations  specifically 
concerned): These consultations have been carried out in the context of the COWI study in order 
to  collect  detailed  information  on  the  potential  impacts  of  establishing  or  revising  OELs  under 
the CMD that is not available in published literature and internet searches.  

In  line  with  the  previous  three  amendments  of  the  CMD,  no  public  consultation  on  this  initiative  has 
been launched for the following reasons: 

  A  broad  consultation  of  various  stakeholders,  social  partners  and  Member  States’  competent 

authorities has been carried out in view of this initiative.  

  This  initiative  concerns  a  very  technical  topic  for  which  the  general  public  does  not  have 
sufficient  expertise.  For  that  reason,  a  more  targeted  consultation  has  been  considered  as  a 
more proportionate approach. 
In the context of the scientific opinions carried out by RAC, stakeholders were allowed to express 
their views and concerns in the early phases of developing the scientific reports on occupational 
exposure limits for acrylonitrile, nickel compounds and benzene.    

 

Due to the exceptional circumstances related to the coronavirus pandemic and the delay caused in the 
legislative procedure concerning this initiative, no inception impact assessment has been published.  

1.  Social Partners Consultation  

1.1. 

Results of the first phase of the Social Partners consultation.  

The first phase of Social Partners consultation closed on 30 September 2017. 

53 

 
 
 
The  Commission  consulted  the  Social  Partners  among  others  on  the  establishment  and/or  revision  of 
further binding OELs in Annex III to the CMD. 

Following a process described in more detail in annex 8 of this report, the Commission identified a first 
proposed list of priority substances for a subsequent amendment revision of the CMD in the first phase 
consultation document90, as follows: 

a)  Nickel compounds under the scope of the CMD 
b)  Acrylonitrile [CAS No 107-13-1] 
c)  Benzene [CAS No 71-43-2] 

Workers' organisations  

Three  trade  unions  replied  to  the  consultation:  the  European  Trade  Union  Confederation  (ETUC), 
European  Confederation  of  Independent  Trade  Unions  (CESI),  European  Federation  of  Building  and 
Woodworkers (EFBWW). They all acknowledged the importance of the existing legislation and a need for 
further action. 

The workers' organisations agreed, broadly, with the issues described in the consultation document and 
confirmed  the  importance  they  attach  to  protecting  workers  from  the  health  risks  associated  with 
exposure to carcinogens and mutagens.  

Concerning the approach regarding the  fourth amendment, ETUC and EFBWW agree with the list of 3 
priority substances identified by the Commission.  CESI considers that the latest available data need to be 
used when revising the CMD. 

As  regards  the  other  substances  to  be  added  to  Annex  III,  while  CESI  suggests  that  they  should  be 
identified on the  basis of sound and independent scientific research, ETUC and EFBWW insist that the 
target of binding OELs for 50 substances has to be achieved by 2020. ETUC has proposed a priority list of 
such substances. After 2020, the process of setting OELs should continue on a dynamic way in order to 
include  most  of  the  substances  at  the  workplace.  In  the  enclosed  annex  of  its  priority  substances  list 
ETUC has indicated it as a candidate for the fourth amendment. 

With  regard  to  Annex  I  to  the  CMD,  ETUC  considered  important  to  include  all  processes  generated 
substances for which IARC monographs are available.  

CESI and EFBWW considered that legislative initiatives should be complemented by other measures, for 
example,  fostering  preventative  health-oriented  behaviour  and 
information  on  best  available 
technology. 

The  workers  do  not  want  to  enter  into  negotiations  under  Article  155  TFEU  concerning  the  third  and 
fourth amendment of the CMD and urge the Commission to make progress on this. 

Employers' organisations 

90 See footnote 16 

54 

 
 
                                                           
Four employers' organisations replied to the consultation: BusinessEurope, the European Association of 
Craft  Small  and Medium-sized  Enterprises  (UEAPME),  the  European  Chemical  Employers  Group  (ECEG) 
and  the  Council  of  European  Employers  of  the  Metal,  Engineering  and  Technology-based  industries 
(CEEMET).   

They  supported  the  objective  to  effectively  protect  workers  from  occupational  cancer,  including  by 
setting  OELs  at  EU  level.  However,  they  also  raised  some  concerns  about  the  approach  taken  when 
setting such limit values. 

The employers in principle supported further revisions of the CMD, subject to certain conditions. In their 
opinion, binding OELs should be set for priority substances only. The process of OELs setting should be 
based on sound scientific evidence, technical and economic feasibility, socioeconomic impact assessment 
and  opinion  of  the  tripartite  ACSH.  While  employers  considered  that  the  Commission’s  criteria  for 
prioritising substances are relevant, they suggested that the criteria of technical and economic feasibility 
should also be included. BusinessEurope and CEEMET emphasized that proposing a series of substances 
on  the  basis  of  unofficial  lists  should  be  avoided,  as  should  setting  an  arbitrary  numerical  target  of 
additional binding OELs without clear criteria of prioritisation. UEAPME and CEEMET stressed the need to 
assess  impact on SMEs  and consider sectoral differences. Employers also highlighted a need to ensure 
coherence with other EU chemicals legislation and suggested that guides, examples of good practice and 
other tools can assist in implementing this Directive.   

For  subsequent  amendments  BusinessEurope  stressed  that  inclusion  of  specific  substances  should 
depend on whether they meet the conditions / criteria mentioned above and whether the preparatory 
work has been completed. ECEG and CEEMET supported the overall process for developing and adopting 
binding  OELs  as  long  as  the  above  criteria  and  processes  are  correctly  applied.  UEAPME,  noted  that 
without  having  seen  concrete  proposals  for  OELs  it  is  not  possible  to  take  a  complete  position.  They 
further suggested that the latest available data need to be used when revising the CMD (supported by 
CEEMET) and that too restrictive OELs could be very burdensome for employers leading to a risk of non-
compliance. 

The employers do not want to enter into negotiations under Article 155 TFEU as the existing preparatory 
procedures  already  involve  Social  Partners.  Although,  they  are  open  to  discussing  in  an  informal  way 
relevant issues. 

1.2.  Results of the second phase of the Social Partners consultation 

The  Commission  launched  a  second  phase  consultation  of  the  Social  Partners  which  closed  on  22 
December 2017. In this second phase consultation, the Commission indicated among others that a first 
candidate list of the following substances is given consideration: 

  Nickel compounds that are carcinogens as defined in the Directive 
  Acrylonitrile [CAS No 107-13-1] 
  Benzene [CAS No 71-43-2] 

55 

 
 
  Diesel Engine Exhaust Emissions (DEEE). At least two approaches are being explored – to address 
this mixture as a process generated substance or to take a component-specific approach91. 

Workers’ organisations 

Three  workers'  organisations  replied  to  the  second  phase  consultation:  the  European  Public  Service 
Union (EPSU), the European Trade Union Confederation (ETUC) and the European Federation of Building 
and  Woodworkers  (EFBWW).  They  all  recognised  the  importance  of  further  improving  the  existing 
legislative framework in line with the proposed Commission action and beyond. 

Concerning Annex III, the workers' organisations agree that the first candidate list for the fourth batch is 
appropriate, as it includes substances that are among priority carcinogens. However, they underline that 
the list must be extended to reach the objective of setting 50 OEL by 2020. As regards the setting of OEL, 
ETUC points the need to define a consistent and more transparent methodology, asking the Commission 
to  consider  its  priority  substances  list.  EFBWW  underlines  that  the  OELs  should  be  health  based  only, 
while  ETUC  stresses  that  socioeconomic  considerations  might  be  relevant  for  adapting  Annex  III, 
although not for Annex I. As a final point, EPSU considers that including some cytotoxic drugs in Annex III 
would be possible, but other actions are needed to tackle the exposure to these substances. 

The workers' organisations agree that the amendment of the CMD should be part of a global strategy to 
prevent  occupational  cancer  in  Europe  and  urge  the  Commission  to  adopt  a  roadmap  combining 
legislative initiatives (e.g. the revision of the Asbestos Directive and the revision of the Optical Radiation 
Directive)  with  non-legislative  actions  and  mainstreaming  work-related  cancer  prevention  in  other  EU 
policies.  

The workers' organisations do not want to launch a negotiation procedure pursuant to Article 155 TFEU. 

Employers' organisations 

Four employers' organisations replied to the second phase consultation: BusinessEurope, the European 
Association of Craft  Small and Medium-sized Enterprises (UEAPME), the European Chemical Employers 
Group (ECEG) and the Council of European Employers of the Metal, Engineering and Technology-based 
industries (CEEMET). They confirmed their support to actions aiming to effectively protect workers from 
occupational cancer, including the setting OELs at EU level but underlined the need to ensure values that 
are proportionate and feasible. 

The  employers'  organisations  support  the  procedures  for  considering  substances  and  setting  OEL, 
underlining  the  need  that  they  are  based  on  the  latest  scientific  information,  proportionate  and 
measurable  and  highlighting  the  importance  of  the tripartite  system.  UEAPME  and  CEEMET  point  that 

91  As  indicated  in  Annex  9,  after  the closing  of  this  two-stage  consultation,  the  co-legislators,  in  the  framework  of  the  second  reivision  of  the 
Directive  2004/37/EC,  added  DEEE  in  the  annex  I  of  the  CMD  and  set  an  corresponding  OEL  in  the  Annex  III,  thereby  pre-empting  the 
preparatory  work  of  the  European  Commission.  Therefore,  as  DEEE  was  addressed  in  the  second  revision  of  the  CMD,  there  was  no  need 
anymore to consider it in the framework of the fourth revision of the CMD. 

56 

 
 
 
                                                           
the  limit values  have  to  be  set  in  a  way which  reduces  workers  exposure  whilst  still  allowing  SMEs  to 
comply. CEEMET also proposes transitional measures where the new OEL will adversely affect industry 
and points that an arbitrary target of the addition of 50 new exposure limits should not be set, as OEL 
should  only  be  proposed  on  an  evidence-based  approach  and  not  in  line  with  the  precautionary 
principle. 

Regarding the scientific body to provide information for the setting of OELs, BusinessEurope thinks that 
there should be a thorough assessment before any decision is taken, while CEEMET believes that SCOEL 
should be the one setting the limit values. 

BusinessEurope encourages the Commission to continue its preparatory work and consultations with the 
ACSH regarding the candidate list of substances for the fourth batch.  

Finally,  ECEG,  BusinessEurope  and  CEEMET  stress  the  importance  of  other  actions  to  achieve  worker 
protection  in  addition  to  legislation,  such  as  guidance  documents,  best  practices,  voluntary  product 
stewardship programmes by companies and sectors, or social partner agreements. 

The employers' organisations do not want to engage into negotiations under Article 155 TFEU. 

2.  Consultation of the ACSH/WPC 

The  Advisory  Committee  on  Safety  and  Health  at  Work  (ACSH)  has  adopted  opinions  for  acrylonitrile, 
nickel compounds and benzene, in the context of the fourth amendment of the CMD. 

The  ACSH  is  proposing  as  possible  approaches  for  these  chemicals  one  or  several  binding  OELs  with 
additional notations for all of them. 

The opinions for all substances adopted by the ACSH are summarised below. 

Acrylonitrile  

The ACSH adopted its opinion for acrylonitrile92 on 4 June 2019, putting forward the following values and 
transition measures:  

  An 8 hours TWA limit value of 1 mg/m³ (0.45 ppm) and a STEL of 4 mg/m³ (1.8 ppm) that would 
apply after a four year transition period starting from the entry into force of the new Directive.  

The  ACSH  strongly  recommended  the  Commission  to  adopt  as  soon  as  possible  a  binding  OEL  for  this 
substance under Directive 2004/37/EC. 

The ACSH also agreed on the Biological Limit Value (BLV) as proposed by RAC93 but note that, at present, 
BLVs  are  not  proposed  under  the  CMD.  It  suggested  that  this  BLV  is  taken  into  consideration  when 
developing the guidance on the practical use of biomonitoring.  

Available 

92 
9170d5ad8ec8/details 
93 60 µg CEV/L blood (erythrocyte fraction of whole blood) 

at: 

https://circabc.europa.eu/ui/group/c9ba7ef7-03a1-41be-b69d-4ab203c3d93f/library/d1f997b8-8c0a-418b-8daa-

57 

 
 
                                                           
Nickel compounds 

The  ACSH  adopted  its  opinion  for  nickel  compounds94  on  4  June  2019,  putting  forward  the  following 
values and transition measures: 

  Two  8  hours  TWA  limit  values  of  0.01  mg/m³  (respirable  fraction)  and  0.05  mg/m³  (inhalable 
fraction) that would apply from 17th January 2025. Until then, an 8 hours TWA limit value of 0.1 
mg/m³ (inhalable fraction) would apply.  

  The ACSH indeed recommended that the date of application ot the OELs for nickel compounds 
should ensure alignment with the date of application of the OEL for chromium (VI) compounds 
adopted  in  Directive  2017/2398/EU95.  Both  groups  of  substances  (nickel  compounds  and 
chromium VI compounds) are indeed frequently occurring in the same sectors and, often, in the 
same  processes.  The  ACSH  is  therefore  of  the  opinion  that  actions  to  reduce  the  exposure  to 
chromium VI and nickel compounds must be coordinated and can benefit from synergies.  

The  ACSH  also  added  that  in  a  limited  number  of  sectors  or  processes,  including  specifically  smelting, 
refineries and welding, face particular difficulties for complying with the proposed OELs. Therefore, the 
ACSH believes that in these sectors or processes, and possibly in other sectors, there may be need for 
using RPE to ensure that the workers are appropriately protected.  

The  ACSH  strongly  recommended  the  Commission  to  adopt  as  soon as  possible  OELs  for  this  group  of 
substances under Directive 2004/37/EC. It also agreed that it would be appropriate to introduce an OEL 
under the Directive 98/24/EC96 for Nickel.   

Benzene 

The ACSH adopted its opinion for benzene on 4 June  201997, putting forward the  following values  and 
transition measures:  

  Two years after entry into force of the Directive, a limit value of 0.5 ppm (1.65 mg/m³) will apply. 
Four years after entry into force of the Directive, a limit value of 0.2 ppm (0.66 mg/m³) will apply.  

In  addition  to  these  values  and  transition  measures,  the  ACSH  agreed  that  the  steel  foundries  sector 
faces particular difficulties for complying with the proposed OELs. Consequently, the ACSH believes that 
in  this  sector,  and  possibly  in  other  sectors,  there  may  be  a  need  for  using  RPE  to  ensure  that  the 
workers are appropriately protected.  

The ACSH strongly recommended the Commission to  adopt as soon as possible a revised binding OEL for 
this substance under Directive 2004/37/EC. 

94 https://circabc.europa.eu/ui/group/c9ba7ef7-03a1-41be-b69d-4ab203c3d93f/library/96b1c237-9dcc-4e3a-b29c-5f5eaf2974da/details 
95 See footnote 12 
96  Directive  98/24/EC  on  the  protection  of  the  health  and  safety  of  workers  from  the  risks  related  to  chemical  agents  at  work.  Available  at: 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01998L0024-20140325 
97 
0e67d752c78a/details 

https://circabc.europa.eu/ui/group/c9ba7ef7-03a1-41be-b69d-4ab203c3d93f/library/f3a12f14-c7bd-42ce-899d-

Available 

at: 

58 

 
 
                                                           
The ACSH also agreed on the usefulness of biomonitoring (BLV) as proposed by RAC98 but note that, at 
present, BLVs are not proposed under the CMD. The ACSH therefore suggested this BLV to be taken into 
consideration when developing the guidance on the practical use of biomonitoring. 

3.  Consultation of other stakeholders 

In  the  context  of  the  COWI  study,  consultation  activites  have  been  carried  out  to  collect  detailed 
information  on  the  potential  impacts  of  modifications  to  the  CMD  that  is  not  available  in  published 
literature and internet searches. Although some information on OELs is available, limited information is 
available  on  concrete  measures  already  in  place  and  that  would  need  to  be  implemented,  should  the 
OELs  be  modified.  The  information  sought  via  consultation  therefore  included  sizes  of  companies, 
sectors and processes that would be affected, number of workers exposed, current air concentrations of 
substances  concerned  (both  8-hour  time  weighted  averages  (8-h  TWA)  and  15-minutes  reference 
periods), risk management measures currently in place, as well as risk management measures that would 
need to be implemented should the OELs be modified and associated costs. 

Consultation carried out for the purposes of this study consisted of the following main activities: 

•  Questionnaires; 

•  Email requests (possibly in combination with questionnaires);  

•  Telephone interviews; 

•  Site visits; 

•  Face to face meetings; 

•  Workshops; 

Mixed methods (combining e.g. questionnaire responses with telephone interviews and site visits) were 
adopted to ensure that a large number of organisations and individuals were able to provide data and 
provide their views within the time constraints and resource limits. Using mixed methods also enabled 
the  study  team  to  gather varying  details  of  information  and  to  explore  information  further  where  the 
need arose. 

3.1.  Targeted Online Questionnaires 

Stakeholders were initially contacted via email. The e-mail provided an overview of the study and a link 
to  the  questionnaires.  If  stakeholders  preferred  to  answer  the  questionnaire  in  a  Word  document  (so 
that  it  could  be  shared  among  several  colleagues,  for  example),  the  stakeholder  was  informed  of  the 
possibility to obtain a word-version upon request. 

Three  separate  questionnaires  were  drawn  up,  each one  created  to  gather  information  from  different 
stakeholder groups: 

•  Questionnaire  1  was  aimed  at  companies  whose  workers  were  exposed  to  nickel  compounds, 

acrylonitrile or benzene; 

98 0.7 µg benzene/L urine and 2 µg S-phenylmercapturic acid (SPMA)/g creatinine 

59 

 
 
                                                           
•  Questionnaire 2 was aimed at occupational health and safety experts; and  

•  Questionnaire 3 was aimed at Member State authorities.  

The  questions  aimed  to  collect  information  on  processes  during  which  worker  exposure  to  the 
substances  in question is likely  to occur, risk management measures  that are already  in place, current 
exposure  concentrations,  risk  management  measures  that  would  need  to  be  implemented  should  the 
limit be lowered, and any other impacts that could result from the introduction of EU level limits. 

Although  many  of  the  responses  provided  a  significant  amount  of  useful  information,  many  of  them 
were  not  sufficiently  detailed.  Other  methods  of  consultation,  allowing  experts  to  question  and  probe 
answers further (namely telephone interviews and site visits), were therefore required to obtain a more 
in-depth understanding of the potential impacts. This includes the above follow-ups. 

3.2.  Telephone interviews 

Both  national  experts  and  substance  experts  were  activated  for  the  purposes  of  the  telephone 
interviews. Telephone interviews were asked for in the online questionnaires as well as through direct 
email and phone contact.  

The purpose of the telephone interviews was to gain more insight into the answers provided in response 
to the questionnaires. It enabled the collection of more detailed information on processes, to pinpoint 
exactly  where  exposure  is  likely  to  occur,  investigating  what  types  of  risk  management  measures  are 
already  in  place  and  how  effective  they  are,  as  well  as  what  risk  management  measures  would  be 
required if limits were lowered and other potential ramifications for the company. 

3.3.  Email requests 

As supplement to the interviews various information was collected by email requests. The purpose and 
questions were similar to those explained above for telephone interviews. 

3.4.  Site visits 

Companies whose activities are likely to be affected by the potential modifications to the CMD were also 
asked whether they would be willing to welcome members of the study team for a site visit. Companies 
to  be  visited,  were  identified  via  the  questionnaire  or  the  contact  was  established  via  EU  trade 
associations. 

The purpose of the site visits was to a gain a more operational understanding of the risk management 
measures currently in place to protect against exposure to the substances concerned, as well as of the 
risk management measures that would be needed should the CMD be modified. 

Detailed  notes  from  each  site  visit  were  drafted  and  sent  back  to  the  company  to  ensure  that  the 
information  recorded  was  accurate.  This  process  also  enabled  the  company  to  add  more  detail  and 
information  to  the  study,  where  possible,  and  to  confirm  the  level  of  confidentiality  required  to  the 
information. 

3.5.  Face-to-face meetings 

60 

 
 
Face-to-face meetings were held with key EU associations for each of the substances. This aimed among 
other things to: 

•  facilitate the collection of more comprehensive data on the relevant sectors, and  

•  facilitate  exchange  of  information  collected  as  part  of  the  associations’  own  socioeconomic 

assessments. 

3.6.  Workshops 

In order to collect information from stakeholders and receive feedback, the consultant attended 
workshops with industry and workshops of the Working Party of Chemicals as listed in the table below.  

Table 18: Workshops attended 

Date 

Substance 

Subject, stakeholders and venue 

22 Jan 2019 

Benzene 

Workshop on RMMs. Representatives of petroleum industry, 
petrochemical industry and Triskelion. Concawe offices in Brussels  

22-23 Jan 2019 

Benzene, nickel, 
acrylonitrile 

Presentation of interim report. Working Party of Chemicals (WPC). 
European Commission, Luxembourg 

19-20 Mar 2019 

Benzene, nickel, 
acrylonitrile 

Presentation of progress note. Working Party of Chemicals (WPC). 
European Commission, Luxembourg 

29-30 Apr 2019 

Benzene, nickel, 
acrylonitrile 

Presentation of draft final report. Working Party of Chemicals (WPC). 
European Commission, Luxembourg 

Source: COWI (2019) 

3.7.  Stakeholders targeted 

The  following  table  summarises  information  on  stakeholder  groups  targeted  and  the  interests 
represented. The table demonstrates that all relevant stakeholder groups have been reached out to.  

Table 19: Stakeholders targeted and interests represented 

Stakeholder type 

Interests represented 

EU Associations 

Interest of industry 

MS Authorities 

Interest of MS authorities 

Manufacturers/users 

Interest of industry 

National industry associations 

Interest of industry 

Trade Unions 

Interest of workers 

Occupational Health & Safety Professionals 

No  particular  interest  -  contacted  in  order  to  obtain  scientific 

61 

 
 
 
Stakeholder type 

Interests represented 

information 

ACSH Working Party on Chemicals (WPC) 

Interests of industry, workers and MS authorities 

Laboratories 

Source: COWI (2019) 

No particular interest - contacted in order to obtain 
information on sampling and analysis 

62 

 
 
 
 
Annex 3: Who is affected and how? 

1.  PRACTICAL IMPLICATIONS OF THE INITIATIVE 

Acrylonitrile  

Table 20: Practical implications of the initiative for acrylonitrile 

Administrations 
Member States must transpose 
the amended Directive into 
national legislation:   
-  assessment of the national 
scenario and potential 
impacts;   

-  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. 

Citizens/Consumers 
-  Some of the quantified costs to 
business may be passed on to 
the citizens/consumers as 
increased prices. However, 
only limited impacts are 
expected.  

-  Workers have the duty to 

Businesses 
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 

comply with the dispositions 
provided by the employers as 
regards the use of preventive 
and protective measures 
necessary to comply with OSH 
legislation (e.g. the newly 
established OEL). 

necessary risk management 
measures (RMMs) (e.g. closed 
systems, local exhaust 
ventilation, improved valves 
and flanges, limitation of 
number of workers exposed, 
personal protection 
equipment) in order to comply 
with the new OEL;  

-  implementation of a sampling 

strategy and airborne 
concentrations measurement 
programme for the chemical 
agents with a new OEL, as part 
of the risk assessment process 
and effectiveness check of the 
existing measures; 

-  ensure that acrylonitrile be 
managed in line with the 
provisions of the carcinogens 
and mutagens national 
legislation;   

-  ensure compliance with other 
provisions 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 OEL, 
collection of records, 
information to competent 
authorities, etc.). 

63 

 
 
 
 
Benzene 

Table 21: Practical implications of the initiative for benzene 

Citizens/Consumers 

-  Some of the quantified  costs 
to business may be passed on 
to the citizens/consumers as 
increased prices of e.g. 
petroleum products and some 
plastics.   

-  Workers have 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 (e.g. the newly 
established OELs). 

Administrations 
Member States must transpose 
the amended Directive into 
national legislation:   
-  assessment of the national 

scenario and potential impacts;   

-  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. 

Businesses 
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 (RMMs) (e.g. 
substitution, closed systems, 
local exhaust ventilation, 
improved valves and flanges, 
limitation of number of 
workers exposed, personal 
protection equipment) in 
order to comply with the 
revised OEL; 

-  implementation of a sampling 

strategy and airborne 
concentrations measurement 
programme for the chemical 
agents with a revised OELV, as 
part of the risk assessment 
process and effectiveness 
check of the existing 
measures; 

-  ensure that benzene be 
managed in line with the 
provisions of the carcinogens 
and mutagens national 
legislation;  

-  ensure compliance with other 
provisions 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 revised OEL, 
health surveillance, if 
appropriate, for chemical 
agents now under the scope 
of the legislation, collection of 
records, information to 
competent authorities, etc.).  

64 

 
 
 
 
Nickel compounds 

Table 22: Practical implications of the initiative for nickel compounds 

Citizens/Consumers 
-  Some of the quantified costs to 
business may be passed on to 
the citizens/consumers as 
increased prices. However, the 
impact should be very limited.  

-  Workers have 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 (e.g. the newly 
established OELs). 

Administrations 
Member States must transpose 
the amended Directive into 
national legislation:   
-  assessment of the national 

scenario and potential impacts; 

-  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 

Businesses 
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 (RMMs) (e.g. closed 
systems, local exhaust 
ventilation, improved valves 
and flanges, limitation of 
number of workers exposed, 
personal protection 
equipment) in order to comply 
with the new OEL;  

-  implementation of a sampling 

strategy and airborne 
concentrations measurement 
programme for the chemical 
agents with a new OEL, as part 
of the risk assessment process 
and effectiveness check of the 
existing measures; 

-  ensure that nickel compounds 
are managed in line with the 
provisions of the carcinogens 
and mutagens national 
legislation;   

-  ensure compliance with other 
provisions 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 OEL, 
collection of records, 
information to competent 
authorities, etc.). 

2.  SUMMARY OF COSTS AND BENEFITS 

Acrylonitrile 

The  table  23  below  summarises  the  benefits  as  calculated  on  the  basis  of  Method  1,  which  relies  on 
Willingness  to  Pay  (WTP)  values  for  avoiding  a  case  of  mortality  and  morbidity.  A  low-high  range  has 

65 

 
 
 
been  provided  that  represents  the  lowest  and  highest  values  estimated  in  this  study  based  on  the 
different  Method 1 approaches  and assumptions. Estimates  on the  basis of Method 2, which relies on 
monetised Disability Adjusted Life Years (DALYs), are of a similar order of magnitude at OEL levels of 1 
mg/m3 inhalable. 

Table 23: Overview of benefits for acrylonitrile 

I. Overview of Benefits (total for all provisions), € over 60 years – Preferred Option (without transition measures) 

Description 

Amount 

Comments 

Avoided costs for 
companies 

€340,000 - €1,100,000 

Avoided costs for 
public sector 

€27,000 - €89,000 

Reduced  absenteeism,  productivity  losses  and  insurance 
payments.  In  addition,  not  quantified  benefits  include  legal 
clarity,  simplification  in  ensuring  legal  compliance  and  a 
more  balanced  level  playing  field  for  businesses  across  the 
EU. 

Having  reduced  health  care  costs.  Avoidance  of  loss  of 
productivity and mitigation of financial loss of national social 
security  systems,  reducing  the  costs  of  healthcare  and  the 
loss  of  tax  revenue  due  to  morbidity  and  mortality.  In 
addition, not quantified benefits include clarity regarding the 
acceptable 
levels  of  exposure,  facilitates  the  work  of 
inspectors by providing a helpful tool for compliance checks. 
Furthermore, the existence of an EU OEL eliminates the need 
for  national  public  authorities  to  independently  evaluate 
each  carcinogen,  removing  an  inefficiency  of  repetition  of 
identical tasks. 

Avoided costs for 
workers & families 

METHOD 1: 

€440,000 - €5,800,000 

METHOD 2: 

€583,000 - €5,430,000 

The  main  intangible  benefits  are  to  workers  and  families: 
More effective protection of their health, reducing suffering 
of  workers  and  their  families,  increased  length,  quality  and 
productivity  of  their  working  lives,  avoiding  premature 
deaths, less costs of informal care 

Note: Estimates are relative to the baseline as a whole (i.e. the impact of individual actions/obligations of the 
preferred option are aggregated together). 

Table 24: Overview of costs for acrylonitrile 

II. Overview of costs, € over 60 years – Preferred option (without transition measures) 

Description 

Stakeholders affected 

Amount 

Compliance costs (one-off) 

Companies 

Compliance costs (recurrent) 

Companies 

Monitoring costs 

Administrative costs 

Single-market 

Companies 

Public sector 

Consumers 

€30,000,000 

-€2,000,000 

€0 

€1,350,000 

Limited impacts expected 

Social costs (employment) 

Workers & families 

€0 

66 

 
 
 
 
Note: Estimates are relative to the baseline as a whole (i.e. the impact of individual actions/obligations of the 
preferred option are aggregated together). 

Nickel compounds 

The table below summarises the benefits as calculated on the basis of Method 2, which relies on 
monetised Disability Adjusted Life Years (DALYs). Estimates on the basis of Method 1, which relies on 
Willingness to Pay (WTP) values for avoiding a case of mortality and morbidity, are approximately 70-
80% of those under Method 1. 

Table 25: Overview of benefits for nickel compounds 

I. Overview of Benefits (total for all provisions), € over 60 years – Preferred Option (without transition measures) 

Description 

Amount 

Comments 

Avoided costs for 
companies 

€3,900,000 

Avoided costs for 
public sector 

€2,200,000 

Avoided costs for 
workers & families 

€72,000,000 - 
€92,000,000 

Reduced  absenteeism,  productivity  losses  and  insurance 
payments.  In  addition,  not  quantified  benefits  include  legal 
clarity,  simplification  in  ensuring  legal  compliance  and  a 
more  balanced  level  playing  field  for  businesses  across  the 
EU. 

Having  reduced  health  care  costs.  Avoidance  of  loss  of 
productivity and mitigation of financial loss of national social 
security  systems,  reducing  the  costs  of  healthcare  and  the 
loss  of  tax  revenue  due  to  morbidity  and  mortality.  In 
addition, not quantified benefits include clarity regarding the 
acceptable 
levels  of  exposure,  facilitates  the  work  of 
inspectors by providing a helpful tool for compliance checks. 
Furthermore,  the  existence  of  an  EU  OELV  eliminates  the 
independently 
need  for  national  public  authorities  to 
evaluate  each  carcinogen,  removing  an 
inefficiency  of 
repetition of identical tasks. 

More effective protection of their health, reducing suffering 
of  workers  and  their  families,  increased  length,  quality  and 
productivity  of  their  working  lives,  avoiding  premature 
deaths, less costs of informal care. 

Note: Estimates are relative to the baseline as a whole (i.e. the impact of individual actions/obligations of the 
preferred option are aggregated together). 

Table 26: Overview of costs for nickel compounds 

II. Overview of costs, € over 60 years – Preferred option (without transition measures) 

Description 

Stakeholders affected 

Amount 

Compliance costs (one-off) 

Companies 

Compliance costs (recurrent) 

Companies 

Monitoring costs 

Companies 

€4,300,000,000 

-€165,000,000 

€2,500,000,000 

67 

 
 
 
 
 
Administrative costs 

Single-market 

Public sector 

Consumers 

€730,000 

Limited impacts expected 

Social costs (employment) 

Workers & families 

€779,000 

Note: Estimates are relative to the baseline as a whole (i.e. the impact of individual actions/obligations of the 
preferred option are aggregated together). 

Benzene 

The table below summarise the benefits as calculated on the bases of Method 1, which relies on 
Willingness to Pay (WTP) values for morbidity. Estimates on the basis of Method 2, which relies on 
monetised Disability Adjusted Life Years (DALYs), were about 60% of the values calculated with Method 
1. 

Table 27: Overview of benefits for benzene 

I. Overview of Benefits (total for all provisions), € over 60 years – Preferred Option (without transition measures) 

Description 

Amount 

Comments 

Avoided costs for 
companies 

€2,000,000 

Avoided costs for 
public sector 

€2,500,000 

Avoided costs for 
workers & families 

€121,000,000 - 
€198,000,000 

Reduced  absenteeism,  productivity  losses  and  insurance 
payments.  In  addition,  not  quantified  benefits  include  legal 
clarity,  simplification  in  ensuring  legal  compliance  and  a 
more  balanced  level  playing  field  for  businesses  across  the 
EU. 

Having  reduced  health  care  costs.  Avoidance  of  loss  of 
productivity and mitigation of financial loss of national social 
security  systems,  reducing  the  costs  of  healthcare  and  the 
loss  of  tax  revenue  due  to  morbidity  and  mortality.  In 
addition, not quantified benefits include clarity regarding the 
levels  of  exposure,  facilitates  the  work  of 
acceptable 
inspectors by providing a helpful tool for compliance checks. 
Furthermore,  the  existence  of  an  EU  OELV  eliminates  the 
independently 
need  for  national  public  authorities  to 
inefficiency  of 
evaluate  each  carcinogen,  removing  an 
repetition of identical tasks. 

More effective protection of their health, reducing suffering 
of  workers  and  their  families,  increased  length,  quality  and 
productivity  of  their  working  lives,  avoiding  premature 
deaths, less costs of informal care. 

Note: Estimates are relative to the baseline as a whole (i.e. the impact of individual actions/obligations of the 
preferred option are aggregated together). 

Table 28: Overview of costs for benzene 

II. Overview of costs, € over 60 years – Preferred option (without transition measures) 

Description 

Stakeholders affected 

Amount 

68 

 
 
 
 
 
 
Compliance costs (one-off) 

Companies 

Compliance costs (recurrent) 

Companies 

Monitoring costs 

Administrative costs 

Single-market 

Companies 

Public sector 

Consumers 

€2,461,000,000 

€5,149,000,000 

€0 

€300,000 

Limited impacts expected – small 
price increase for fuels 

Social costs (employment) 

Workers & families 

€0 

Note: Estimates are relative to the baseline as a whole (i.e. the impact of individual actions/obligations of the 
preferred option are aggregated together). 

69 

 
 
 
 
 
 
Annex 4: Analytical methods 

1.  MONETISATION OF THE HEALTH IMPACTS  

1.1.  Health impacts 

The  introduction  of  an  OEL  is  expected  to  result  in  a  reduction  in  the  occupational  exposure  to  the 
carcinogen concerned. The extent of such reduction depends on the current levels of exposure, as well 
as on the projected future levels of exposure in the absence of the proposed measure, i.e. the 'baseline 
scenario'.  

For a given reduction in exposure levels, it is then necessary to estimate the expected decrease in the 
incidence of cancer cases and other non cancer health effects over a given timeframe to the substance in 
question.  

The current and future cases of ill health have been estimated for both cancer and non-cancer endpoints 
using the following inputs: 

  The Exposure Risk Relationships (ERRs) and Dose Response Relationships (DRRs); 

  The numbers of workers exposed; 

  The exposure concentrations; and 

  Trends in the exposed workforce and exposure concentrations. 

On  this  basis,  we  can  therefore  calculate  the  health  impact  which  can  be  defined  as  the  number  of 
persons (“cases”), either suffering from cancer and/or experiencing some noncancer health effects due 
to this occupational exposure. 

It has to be kept in mind that  

 

 

the  ERR  only  applies  on  the  most  critical  cancer  site,  which  is  given  by  the  assessment  of  the 
European  Chemicals  Agency  / Committee  for  Risk  Assessment (ECHA/RAC),  and  only  comment 
qualitatively  on  further  cancer  sites,  which  may  be  linked  to  exposure  to  the  respective 
substance; 

the  DRRs  are  derived  by  referring  to  the  most  critical  non-cancer  effects  quantitavely.  The 
effects, which were regarded as the most critical ones by RAC are selected and we only comment 
qualitatively on  further  non-cancer  effects, which may  be  linked  to  exposure  to  the  respective 
substance 

  as  there  is  even  less  scientific  consensus  on  the  increase  of  effect  severity  with  increasing 
exposure  concentration  and  the  respective  data  are  often  not  adapted  to  the  workplace 
exposure scenario, we focus on the fraction of workers affected at the different exposure levels, 
when we establish a DRR, without taking into account the increase of severity of effects. 

70 

 
 
Therefore,  the  calculated  health  impact  (e.g.,  in  terms  of  “number  of  estimated  cases  with  health 
impairments”)  is  not  identical  to  the  “real”  health  impact,  but  is  just  an  approximation,  which  may 
underestimate  the  full  impact  of  the  occupational  exposure  to  the  respective  substances.  However, 
there are other uncertainties leading to under- or overstimates. These are further developed further in 
this annex.   

Exposure Risk Relationships 

The starting  point  for a cancer  risk impact  assessment  is the OEL proposed by RAC and the respective 
RAC  opinion,  together  with  the  annexed  background  report.  For  the  three  substances,  RAC  found 
significant  arguments  for a mode-of-action based threshold and used this concept  for proposing OELs. 
No conclusions regarding incidence and severity of effects above the OEL is presented in these reports.  

The  OEL  proposed  by  RAC  is  used  to  define  a  zero  response,  i.e.,  0  %  of  the  exposed  individuals  are 
assumed to suffer from the respective health effect, if exposed for all of their working life time to this 
OEL. RAC does not derive any ERR for the range above the proposed OEL. As the ERR is essential for the 
benefit assessment of the current study, an ERR has been established for this impact assessment.  

As  part  of  this,  it  has  been  assessed  which  of  the  existing  dose-response  relationships  is  the  most 
adequate, following the mechanistic conclusions in the RAC opinion. Based on RAC’s assessment we use, 
where  available,  sublinear  exposure  risk  relationships  of  high  quality,  which  follow  a  similar  mode-of-
action argumentation as RAC. They are used to describe cancer risks above the OEL. 

If the ERR is not already provided for a working lifetime exposure scenario, the respective transformation 
has  to  be  calculated:  working  life  time  is  assumed  to  be  40  years,  with  work  day  exposure  for  8 
hours/day,  5  day/week  in  48  weeks  of  a  year.  It  is  a  conservative  estimate  based  on  the  most  critical 
cancer site (cancer risk associated with highest risk). 

Dose Response relationships 

For non-cancer endpoints, the RAC opinion as well as other recent evaluations and literature reports are 
scrutinized  to  identify  the  most  relevant  endpoints  for  humans.  Relevance  means  that  existing 
information  makes  it  likely  that  effects  might  occur  in  humans  at  exposure  levels  above  the  OEL 
proposed  by  RAC,  which  are  of  relevance  in  European  industries.  Human  data  are  preferred  over 
experimental animal data. Experimental data are used as supportive information only, where sufficient 
human dose-response information is available to derive a DRR. Where insufficient human information is 
available, we have to rely on experimental animal data. 

Data from original toxicological and epidemiological studies, referenced by RAC or national committees 
as being qualified and demonstrating a dose-response, are selected and searched for effect levels linked 
to  a  specific  fraction  of the  exposed  (humans or  animals).  If  not  contradicted by  the overall  weight  of 
evidence,  this  slope  reported  in  such  a  study  is  adopted  for  the  DRR.  If  effects  are  reported  on  a 
continuous  scale,  this  needs  to  be  transformed  to  quantal  data  (i.e.  the  incidence  of  effects  in  the 
exposed population), which often requires certain assumptions. 

71 

 
 
In case animal data are used, data are transformed to the human situation, e.g. by applying allometric 
scaling factors in accordance with the ECHA Guidance on Information Requirements and Chemical Safety 
Assessment, R.8; Characterisation of dose [concentration]-response for human health99. 

The number of workers exposed 

It  is  important  to  calculate  the  number  of  workers  potentially  exposed  to  a  substance  in  order  to 
calculate the potential benefits of implementing any new measures. For each substance discussed in this 
Impact Assessment Report, several datasets have been identified. 

As  soon  as  these  datasets  have  been  identified,  there  is  a  need  to  select  those  which  are  the  most 
representative  of  the  current  reality.  For  example,  only  datasets  on  acrylonitrile  at  the  EU  level  have 
been  selected.  Indeed,  it  is  likely  that  there  are  significant  differences  between  the  Member  States  in 
terms of numbers of workers exposed. Therefore, extrapolating the number of workers exposed at the 
EU level on the basis of figures at Member States level would lead to wrong estimates.  

1.2.  Monetisation of the health impacts 

Specific guidance is provided in the Better Regulation (BR) Toolbox for health impacts (BR Tool #31). This 
is summarised in the table below. 

Table 29: Better Regulation Toolbox on social impacts 

Aspect 

Guidance 

Health impacts 

Direct impacts 

Indirect impacts: does the option influence the socio-economic environment that can 
determine health status? 

To assess direct and indirect health impacts monetary and non-monetary methodologies can 
be used. 

Non-monetary approaches: Quality adjusted life years (QALYs), Disability adjusted life years) 
(DALYs), Healthy life years (HLYs). 

Monetary approaches: preference-based approaches Willingness to pay (WTP), Willingness 
to accept (WTA) -> Value of Statistical Life (VOSL), Value of Life-Year (VOLY), accounting-style 
approaches (cost of illness method=only medical expenses, human capital method=loss of 
future earnings in case of disability or premature death) 

Source: COWI (2019) 

Focusing on the example of cancer, the costs of cancer can be divided into: 

99 https://echa.europa.eu/documents/10162/13632/information_requirements_r8_en.pdf/e153243a-03f0-44c5-8808-88af66223258 

72 

 
 
 
 
 
 
 
                                                           
  Direct costs:  These are the  costs of healthcare,  in other words, the  medical costs  associated with 
the treatment of cancer and other costs, including non-medical costs, that arise directly as a result 
of  cancer,  for  example  those  related  with  care  and  the  costs  to  employers.  Healthcare  costs  are 
those  associated  with  the  treatment  and  services  patients  receive,  including  the  cost  of 
hospitalisation,  surgery,  physician  visits,  radiation  therapy  and  chemotherapy/  immunotherapy. 
Depending  on  the  structure  of  national  health  care  provision,  these  costs  may  be  borne  fully  or 
partially  by  the  government  (tax  payers).  Direct  medical  costs  associated  with  cancer  vary 
significantly by cancer type and also vary over time. Indeed, it has been noted that cancer costs are 
highest in the initial period following diagnosis and, among patients who die from their disease, at 
the end of life; they are lowest in the period between the initial and end of life periods, following a 
“u-shaped” curve  (Yabroff et al., 2012)100. Other direct costs may  be  incurred by the patients (say 
the cost of transport to attend appointments) but also by their family/friends, for example, through 
providing unpaid care.  

  Indirect costs: These are the monetary losses associated with the time spent receiving medical care, 
including  productivity  losses  due  to  time  spent  away  from  work  or  other  usual  activities  and  lost 
productivity due to premature death. Employers might also bear costs indirectly through inter alia 
loss of output; payments related to sick leave; administrative costs related to a worker’s absence; 
additional  recruitment  costs;  loss  of  experience/expertise;  overtime  working;  compensation 
payments  (although  this  may  be  covered  by  some  form  of  employer’s  liability  insurance);  and 
insurance  premiums.  Depending  on  the  national  structure  of  social  security  provision,  the 
government (tax payers) may also bear the costs of any disability/social security payments and will 
also suffer losses through foregone tax receipts. 

  Intangible  costs:  These  include  the  non-financial  ‘human’  losses  associated  with  cancer,  e.g. 

reduced quality of life, pain, suffering, anxiety and grief. 

In  economic  impact  terms,  the  total  social  costs101  of  ill  health  are  measured  by  the  costs  borne  for 
health care provision, together with lost output (including productivity losses), gross wage and non-wage 
labour costs of absent workers (such as loss of experience), administrative costs and the intangible costs. 
These represent the direct and indirect resource costs and the non-market ‘external’ costs of illness. The 
other costs listed above (e.g. insurance premiums) relate to what are commonly referred to as ‘transfer 
payments’, which do not give rise to net welfare effects. As a result, they are not considered in economic 
analyses, even though they may be important in financial terms to an individual worker or an employer. 

100 Yabroff KR et al. (2012):  Economic burden of cancer in the US: Estimates, projections and future research, Cancer Epidemiology Biomarkers 
& Prevention, 20 (20) pp 2006-2014, available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3191884/ 
101 From a welfare economic perspective.  

73 

 
 
 
                                                           
1.3.  The Model 

1.3.1.  Introduction 

The following table provides a first overview on the expected key endpoints per substance. 

Table 30: Carcinogenic and non-carcinogenic endpoints 

Substance 

Carcinogenic endpoints 

Non-carcinogenic endpoints 

Nickel and compounds 

Lung cancer 

Acrylonitrile 

Benzene 

Source: COWI (2019) 

Brain cancer 

Leukaemia 

Pulmonary fibrosis, reproductive 
toxicity 

Neurotoxicity, nasal irritation 

Leukocytopenia 

The key model inputs are summarised below. The inputs are those parameters whose variation changes 
the results and for which the model is run multiple times to derive a benefits curve. 

Table 31: Key model inputs 

Parameter 

Explanation 

Rx: Estimate of the risk or 
fraction of workers affected 

Exposure-Risk Relationship (ERR) or Dose-Response Relationship (DRR) 

ExW: Exposed workforce 

Number of workers exposed at different points in time 

Cx: Exposure concentration 

Source: COWI (2019) 

8-hr TWA (time-weighted average) that the workers are exposed to (real 
concentration, i.e. if personal protection equipment (PPE) is currently worn, the 
measured concentrations are adjusted to take into account PPE where 
possible) 

In  addition  to  the  inputs,  the  model  is  underpinned  by  a  range  of  default  assumptions  regarding  the 
onset of the disease and its effects. These assumptions differ by substance but do not change depending 
on the variations in the input data. Some of these assumptions are a simplification of complex real life 
scenarios or best estimates (where authoritative evidence could not be identified from readily available 
literature).  

The key areas in which assumptions had to be made to enable the calculations are set out below. 

Table 32: Key assumptions and their consequences for the sensitivity analysis 

Parameter 

Explanation 

74 

 
 
 
MinEx 

MaxEx 

Onset of the disease 

The minimum exposure duration required to develop the endpoint 

The time needed to reach the maximum risk (i.e. after the MaxEx has been reached, the risk 
of effects do not increase) 

ModEx 

The modelled exposure duration (the ERRs and DRRs are for a 40 year period) 

Lat 

Dist 

The latency with which the effect is demonstrated 

The distribution of cases over the period between MinEx and 60 years 

Mortality 

Mortality rate as a result of the relevant condition 

The effects of the disease 

Value of a case  

Monetary value of a case taking into account the direct, indirect, and intangible costs 

Source: COWI (2019) 

The model provides a good approximation of the order of magnitude of the expected impacts and the 
core calculations are supported by sensitivity analysis. The outputs of the model include: 

•  The  number  of  new  cases  for  each  health  endpoint  assigned  to  a  specific  year  in  the  60  year 

assessment period; 

•  The Present Value (PV) of the direct, indirect, and intangible costs of each case. 

1.3.2.  Key model inputs 

i.  Rx: estimate of the risk or fraction of workers affected 

The estimate of the risk or fraction of workers affected: 

  For cancer: Exposure-Risk Relationship (ERR) i.e. excess risk of developing cancer due to lifetime 

occupational exposure to a substance (taken here to mean 40 years); and 

  For non-cancer endpoints: Dose-Response-Relationship (DRR), i.e. the proportion of workers that 

will develop an endpoint when exposed to a certain level. 

ii. 

ExW: Exposed workers 

Several scenarios are modelled for the exposed workforce. It is not possible to take into account all the 
complexities of real life workforce changes and these scenarios are theoretical constructs/simplifications 
which are designed to provide order of magnitude estimates without the need to construct a very large 
number of scenarios to cover all the types of workforce dynamics. 

Two  distinct  issues  are  usually  covered  under  the  term  ‘turnover’.  Primarily,  turnover  refers  to  the 
natural turnover rate resulting from workers leaving their employer and new workers joining. In addition, 
it can refer to the turnover triggered by those that are absent from work due to illness and replaced by 
others. 

75 

 
 
 
However, turnover refers to the rate by which workers change employment type as it is considered that 
often  workers  when  leaving  one  employer  are  employed  for  similar  work  by  another  employer.  As 
consequence workers may be exposed for longer time in similar jobs that indicated by the average times 
workers are employed by the individual employer.  

It is assumed that there is a turnover of 5% per year. The 5% per year is lower than the turnover ratios in 
most  of  the  published  literature  and  Eurostat,  which  are  typically  derived  at  the  level  of  individual 
companies rather than sectors. 

iii.  Cx: Exposure concentration 

The method has been applied for all substances under CMD 4 as follows: 

•  Exposures  are  for  each  sector  or  sub-sector  represented  by  log-normal  distributions  fitted  to 

available data on e.g. median values and 95th percentiles.  

•  The exposure distributions are considered to represent the variation in the exposure of each worker 

and among workers; 

•  For all concentrations below the threshold (if any), the effect is 0; 

•  By introduction of the OELV, it is assumed that the 95th percentile should be reduced to a level at or 

below the OELV; 

•  As a result of the implemented measures, the general exposure levels would  be reduced at a rate 
comparable to the reduction in the 95th percentile i.e. the entire distribution is changed. The new 
percentiles  can  be  calculated  as:  percentilenew  =  percentileold  *  OEL /  95th
old.  By  this,  it  is  assumed 
that the variance of the lognormal distribution is the same before and after introduction of the OEL, 
but the AM is reduced with the same ratio as the 95th percentile. 

•  Some 5% of the exposure levels of the new percentile will be above the OEL. In some of the previous 
CMD  projects  it  has  been  assumed  that  all  exposure  above  the  OEL  is  reduced  to  the  OEL,  but  it 
follows from the 95th percentile model that some measured concentrations would still be above the 
OEL.  

In order to reduce the possible overestimation of the effect of introduction of an OEL, to the extent the 
available data allow, specific distributions should be developed for subsectors, SEGs, specific work areas 
(less well defined than the SEGs), regional sectors (e.g. different distribution for MS with an OEL and MS 
without an OEL), etc. The challenge, however, have not been to obtain exposure concentration datasets 
for  different  SEGs,  but  to  obtain  detailed  data  on  number  of  workers  within  the  different  SEGs.  In 
practice, it has been the availability of data on workers by SEG or subsectors which has been determining 
for the necessary aggregation into sectors.  

When  establishing  the  various  exposure  distributions,  the  existing  OELs  in  MS  have  been  taken  into 
account. Consequently, it has not been necessary to take the existing OELs into account when estimating 
the effects of introduction of an OEL. For nickel compounds, however, due  to complexity and the fact 

76 

 
 
 
that the national OELs address different fractions, it has not be possible to fully reflect existing OELs in 
the exposure distributions.  

1.3.3.  Key assumptions 

i.  MinEx and MaxEx – The minimum exposure duration required to develop the endpoint 

The model  assumes  that  no  cases  arise  until  the  minimum  exposure  duration  required  to  develop the 
endpoint (MinEx) has expired, see table 33 below. The default MinEx is two years for cancer, a standard 
assumption  for  a  chronic  condition.  The  minimum  exposure  periods  in  the  table  below  have  been 
derived using a precautionary approach that maximises worker protection. The MaxEx reflect the time 
needed  to  reach  the  maximum  risk  (i.e.  after  the  MaxEx  has  been  reached,  the  risk  of  effects  do  not 
increase). 

Table 33: Minimum & maximum exposure duration to develop a condition (MinEx & MaxEx) 

Substance 

Endpoint 

MinEx (years) 

MaxEx (years) 

Nickel compounds 

Lung cancer 

Nickel compounds 

Pulmonary fibrosis  

Nickel compounds 

Reprotoxic toxicity 

Acrylonitrile 

Brain cancer 

Acrylonitrile 

Irritation  

Benzene 

Benzene 

Leukaemia 

Leukocytopenia 
(haematotoxic effects) 

Source: COWI (2019) 

2 

1 

0 

2 

0 

2 

0 

40 

22 

0.25 

40 

2 

20 

6 

ii. 

Dist – the distribution of cases between start of exposure and Year 59 

Valuing the cost of occupational illness involves applying discounted costs to future cases which requires 
that the estimated cases over a 60 year period are assigned to specific years. However, the ERRs and 
DRRs developed under this study are for 40 years of exposure. 

‘Dist’ refers to the distribution of cases between start of exposure and Year 59, also taking MinEx into 
account.  This  differs  between  endpoints.  The  main  difference  is  between  cancer  and  non-cancer 
endpoints; 

iii. 

Cancer 

77 

 
 
 
 
 
For reasons of simplicity, the following approach is used to distribute the total 40-year cancer risk (i.e. 
not incidence but risk since incidence is delayed due to latency) over the 60 year period: It is assumed 
that no risk arises until MinEx has expired. It is assumed that, subsequently, the distribution is linear, i.e. 
0% of the excess risk arises in year 2 and 100% of the excess risk arises by year 40. The annual number of 
cases after MinEX is then used as a proxy for the number of cases until 60 years.  

Figure 4 - Brain cancer risk of exposure to acrylonitrile – distribution over time (source: COWI study 
(2019)) 

iv. 

Default for non-cancer endpoints  

While  the  further  calculation  is  straightforward  for  the  cancer  endpoints,  the  estimations  are  more 
challenging for the non-cancer endpoints.  

Typically, the fraction affected achieves that predicted by the DRR as soon as MaxEx expires and remains 
constant over the 40 year DRR period (although the certainty of the ‘fraction’ estimated on the basis of 
the DRR increases towards the end of the period). As a default assumption, two years has been chosen 
as a conservative MaxEx. 

With  a  MinEx  of  0  year  and  a  MaxEx  of  2  years  for  cancer  endpoints,  the  fraction  affected  that  is 
calculated on the basis of the DRR is the same between 2 years and 40 years and increases in a linear 
manner between Year 0 and Year 2.  

78 

 
 
 
 
 
 
Figure 5 - Non-cancer endpoints – fraction affected over time - example with a MaxEx of 2 years  
(source: COWI (2019)) 

v. 

Latency 

Cancer endpoints  

Similar to the approach used in CMD 3, by way of simplification, a single latency  value  is used for the 
calculation  of  the  core  scenario.  According  to  Rushton  et  al.  (2012),  all  solid  tumours  are  expected  to 
have a latency of 10-50 years, meaning that the average latency is 30 years. A latency of 30 years is used 
as a default for cancer endpoints. 

As  noted  in  the  methodological  note  for  CMD  3,  40  years  of  exposure  and  30  years  of  latency  would 
translate into a 70-year assessment period which is longer than the assessment period used in the CMD 
3  study  and  the  current  study.  In  order  for  the  assessment  not  to  underestimate  the  benefits  (longer 
latency  reduces  the  benefits  since  they  are  discounted  at  lower  factors)  the  CMD  3  study  and  the 
previous Impact Assessments for the OELs under the CMD which relied on an assessment period of 60 
years, used a latency period of 10 years. 

In  order  to  avoid  underestimations  of  the  current  burden  of  disease  and  avoid  inconsistences  in  the 
applied latency periods used for estimations of the current and future burden of disease, latency periods 
in  accordance  with  those  reported  in  the  literature  have  been  applied.  Latency  periods  for  the  cancer 
endpoints are shown in the table below. 

Table 34: Latency (Lat) periods of cancer endpoints 

Substance 

Endpoint 

Lat (years) 

Nickel compounds 

Lung cancer 

Acrylonitrile 

Benzene 

Source: COWI (2019) 

Brain cancer 

Leukaemia 

79 

30 

30 

5 

 
 
 
 
 
Non-cancer endpoints 

The estimated latency period for the non-cancer endpoints in this study is 0 years. There is very limited 
evidence for latency of the relevant non-cancer conditions. 

Table 35: Latency (Lat) periods of non-cancer endpoints 

Substance 

Endpoint 

Lat (years) 

Nickel compounds 

Pulmonary fibrosis 

Nickel compounds 

Reprotoxic toxicity 

Acrylonitrile 

Benzene 

Source: COWI (2019) 

Irritation 

Leukocytopenia  
(haematotoxic effects) 

0 

0 

0 

0 

vi.  ModEX  - the modelled exposure duration 

The ERRs and DRRs are for a 40 year period. The modelled exposure duration is thus 40 years. 

Whilst  it  is  unlikely  that  a  single  worker  is  exposed  to  a  substance  at  a  constant  concentration 
throughout  their  whole  working  life,  the  40  year  period  has  been  chosen  in  order  to  be  protective  to 
workers by assuming a worst-case scenario. The evidence used for the development of the ERR means 
that the greatest certainty about the ERR is at lifetime exposure, i.e. 40 years.  

It is highly likely that the real exposure duration is shorter than ModEx (the modelled exposure duration) 
and  this  have  been  taken  into  account  by  use  of  the  staff  turnover  for  the  estimations  as  described 
elsewhere.  

vii.  MoR – mortality rate 

Mortality  rate  as  a  result  of  the  relevant  condition  is  important  since  different  monetary  values  are 
applied to mortality and morbidity. The mortality rates used in the model are given below. 

Table 36: Mortality rate (MoR) 

Substance 

Endpoint 

MoR  

80 

 
 
 
 
 
Nickel compounds 

Lung cancer 

Nickel compounds 

Pulmonary fibrosis 

Nickel compounds 

Reprotoxic toxicity 

Acrylonitrile 

Brain cancer 

Acrylonitrile 

Irritation 

Benzene 

Benzene 

Source: COWI (2019) 

Leukaemia 

Leukocytopenia  
(haematotoxic effects) 

80 

0 

0  

80 

0 

80 

0 

viii. 

Treatment period 

The  treatment  periods  used  in  the  model  are  given  below.  The  end  of  the  treatment  period  signifies 
either a fatal or illness-free outcome. 

Table 37: Treatment period 

Substance 

Endpoint 

Treatment period (years) 

Nickel compounds 

Lung cancer 

Nickel compounds 

Pulmonary fibrosis 

Nickel compounds 

Reprotoxic toxicity 

Acrylonitrile 

Acrylonitrile 

Benzene 

Benzene 

Source: COWI (2019) 

Brain cancer 

Irritation 

Leukaemia 

Leukocytopenia  
(haematotoxic effects) 

5 

5 

5 

5 

1 

5 

1 

ix.  Monetary value of the relevant endpoint 

The approach to the monetisation of ill health effects is based on the following approach. 

Table 38: Benefits framework 

81 

 
 
 
 
Category 

Direct 

Healthcare 

Informal care102 

Cost 

Notes 

Cost of medical treatment, including 
hospitalisation, surgery, consultations, 
radiation therapy, 
chemotherapy/immunotherapy, etc. 

Opportunity cost of unpaid care (i.e. the 
monetary value of the working and/or 
leisure time that relatives or friends 
provide to those with cancer)  

Cost for employers (e.g. liability 
insurance) 

Cost to employers due to insurance 
payments and absence from work 

Indirect 

Mortality – productivity loss 

Morbidity – lost working days 

Intangible 

Approach 1 WTP: Mortality 

The economic loss to society due to 
premature death 

Loss of earnings and output due to 
absence from work due to illness or 
treatment 

A monetary value of the impact on 
quality of life of affected workers  

Approach 1 WTP: Morbidity 

Approach 2 DALY: Mortality 

Approach 2 DALY: Morbidity 

Source: COWI (2019) 

Two approaches to the monetisation of intangibles have been adopted for the purposes of this study:  

•  Approach 1: Application of a single WTP value to each case; and 

•  Approach 2: Use of DALYs (Disability adjusted life year) and their monetisation. 

1.4.  Benefits assessment 

The health benefits of implementing new or revised OELs are then calculated in terms of the costs of ill 
heatlh avoided. 

Benefits to workers & families 

The direct and indirect resource costs are estimated using market-based information, for example, data 
on health care costs, and estimates of lost output (i.e. the value of a day’s work). 

102 A decision has been taken to include informal care costs in this analysis even though some elements of these costs may also have been included 
in  individuals’  willingness  to  pay  values  to  avoid  a  future  case  of  ill  health.  This  decision  may  result  in  an  overestimate  of  the  benefits  as 
generated by this study.  

82 

 
 
 
                                                           
Added to these are the ‘human’ or intangible costs associated with a case, which are measured in terms 
of an individual’s willingness to pay for the reduction in the risk of mortality or morbidity (Approach 1) or 
monetised DALYs (Approach 2).  

Under Approach 1, the most commonly used means of estimating individuals’ WTP for a reduction in the 
risk  of  an  illness  is  through  the  use  of  experimental  markets  and  survey  techniques  (e.g.  contingent 
valuation or contingent  ranking studies)  to directly elicit individuals’ WTP for a reduction in the risk of 
death or morbidity.  

The key measures are the value of a statistical life – a VSL – and the value of a case of morbidity (value of 
cancer morbidity VCM or value of morbidity VM). The VSL is essentially a measure of a change in the risk 
of fatality, where  this is found by determining individuals’ willingness  to pay for a small change  in risk 
which is then summed across the population at risk.  

1.4.1.  Benefits to employers 

The benefits of introducing OELVs have obvious benefits for workers, namely in terms of their health but 
also, indirectly, on their earnings. Employers will also reap benefits from their employees being less at 
risk of occupational illness. Such benefits include: 

•  higher  labour  productivity resulting  from  reductions  in  absenteeism  and  associated  production 

losses; 

•  reduced administrative or legal costs relating to employees who are ill; and 
•  reduced sick leave payments. 

1.4.2.  Benefit to employers and workers – lost earnings and productivity losses 

Individuals will incur costs associated with their inability to work in terms of a loss of earnings, including 
losses linked to days of for treatment as well as days off due to illness. Luengo-Fernandez et al. (2013) 
developed  estimate of  the  magnitude  of such  costs  by  Member  State  in  terms  of  an  average  cost  per 
fatal or non-fatal cancer. These included what are referred to as “productivity losses” due to early death 
and then lost  working days due  to morbidity effects. Across all cancers, an average  figure  of €5,047 is 
given for productivity losses and €1,118 for the costs associated with lost working days due to morbidity 
effects (with these based on lost wages as the measure of lost output).  

There are difficulties in including the type of estimates generated by Luengo-Fernandez et al. (2013) for 
lost working days within the analysis carried out here due to the potential for double counting. It is not 
clear  whether  the  figures  adopted  in  this  study  to  reflect  the  intangible  or  human  costs  of  cancer 
mortality and morbidity (i.e. €4 million and €400,000 respectively) also include an element related to the 
loss of income. If they do, then to include a separate cost item to reflect lost income would result in a 
double-counting of impacts.  

The decision has therefore been taken not to include an additional element for lost income for mortality 
effects. However, due to uncertainty as to what may be captured by the value adopted here for cancer 
morbidity, lost income due to lost working days is considered within this analysis. 

83 

 
 
 
This inclusion may result in an overestimation of the economic costs associated with cancer morbidity. 
However, the exclusion of lost output for cancer mortalities may also lead to an underestimation if these 
are not fully accounted for within the value of a statistical life figure used here to reflect the intangible or 
human costs of a cancer.  

1.4.3.  Benefits to the public sector – cost of healthcare 

Cancer cases: key data from Luengo-Fernandez, et al (2013)103 have been used for the calculation of the 
avoided healthcare costs of illness. EUR 7000 is used in the model as the average cost for “all cancers”. 

Leukocytopenia: there is no available data on the clinical process for leukocytopenia. It is assumed that 
performing  a  diagnosis  will  require  visits  to  the  general  practitioner  followed  by  consultation  with 
specialists.  Probably  not  all  patients  would  need  consultations  with  specialist  including  hospital. 
Consultation  at  the  general  practitioner,  and  subsequent  treatment,  might  cost  a  few  hundred  euro, 
while the costs of specialist consultation could be several thousand euro. On average the cost for getting 
the diagnosis and the subsequent treatment is estimated at €1,000.  

Pulmonary  morbidity:  The  cost  of  treatment  for  pulmonary  morbidity  is  based  upon  costs  for  chronic 
obstructive  pulmonary  disease  (COPD).  COPD  is  largely  caused  by  smoking  and  is  characterised  by 
progressive,  partially  reversible  airflow  obstruction,  systemic  manifestations 
(skeletal  muscle 
dysfunction,  depression,  and  secondary  polycythaemia),  and  increasing  frequency  and  severity  of 
exacerbations.  The main symptoms, which are usually insidious in onset and progressive, are shortness 
of breath and inability to tolerate physical activity104. As such, the UK Department of Health Reference 
costs  2015/16105  provide  a  comprehensive  estimate  of  the  costs  associated  with  the  treatment  of  the 
different conditions.  From these, the healthcare costs for pulmonary morbidity are estimated at €1,000 
per year. 

Reproductive  toxicity  (miscarriages):  The  cost  of  treatment  for  reproductive  toxicity  (miscarriages)  is 
taken  from  UK’s  National  Health  Service  (NHS)  Reference  costs106  where  the  cost  of  a  “Threatened  or 
Spontaneous  Miscarriage,  with  Interventions”  is  £1,908  and  that  of  a  “Threatened  or  Spontaneous 
Miscarriage, without Interventions” is £580.   From these, the healthcare costs for reproductive toxicity 
(miscarriages) are estimated at €1,000 per year. 

Nasal irritation: no data has been identified for the cost of treatment for nasal irritation, €200/year has 
been assumed since different severities are covered (from mild which require no treatment to severe). 

103 Luengo-Fernandez et al. (2013): Economic burden of cancer across the European Union: apopulation-based cost analysis; Lancet Oncology; 
14; 1165-75 
104 McIvor A. (2007): Chronic Obstructive Pulmonary Disease. BMJ 334; 798  
105 UK DoH (2016): UK Department of Health, Reference costs 2016. Available at: https://www.gov.uk/government/publications/nhs-reference-
costs-2015-to-2016  
106 NHS (2017) : Reference costs. Available at: https://improvement.nhs.uk/resources/reference-costs/ 

84 

 
 
                                                           
2. 

COST MODEL 

2.1.  Compliance cost assessment 

2.1.1.  Introduction 

This  section  describes  the  methodology  for  compliance  cost  assessment  used  across  the  three 
substances. For benzene, some costs estimates has been based on sector-specific studies. 

The compliance costs for companies are basically estimated on the basis of: 

•  Risk Management Measures (RMMs) needed for reducing the air exposure levels from the actual 

levels to the target level. 

•  The costs of the RMMs (on-off and recurrent) for each company and/or workstation. 

•  The life span of the RMMs. 

•  Number of companies and/or workstations. 

The costs are calculated in a worksheet model. For some sectors, where non-specific data are available, a 
likelihood model is applied. The likelihood model calculates  the  costs for a group of similar companies 
incurred  in  reducing  air  exposure  to  a  target  OEL  based  on  an  assumed  sequence  of  RMM 
implementation  which  is  determined  by  suitability,  effectiveness,  and  cost.  The  model  is  run  several 
times to construct a continuous cost curve. 

For  other  sectors,  where  the  RMMs  to  be  applied  are  more  well-described,  a  more  simple  model  is 
applied, but the same unit costs and life span parameters are used as in the more complex model.  

2.1.2.  Key model inputs and assumptions 

i. 

Discount rate 

The static discount rate is 4%: this is taken over the 60 year period. A dynamic discount rate is taken in 
the sensitivity analysis. The dynamic rates start at 4% for the first 20 years; it then decreases to 3% for 
the remaining 40 years. 

ii. 

Affected workers and worstations 

Each company size was in the likelihood model assumed to have an average number of workers affected 
and associated workstations requiring adjustment, shown in the table below. 

Table 39: Number of workers and workstations 

Size of company 

Number of workers affected  

Number of workstations 

Small 

Medium 

Large 

Source: COWI (2019) 

2 

27 

75 

1 

14 

40 

85 

 
 
Three different costs, all present values for 60 years, are calculated: TOTAL, (one-off + recurrent) one-off 
costs, and recurrent. 

iii. 

RMMs considered 

The likelihood model considers following types of RMMs: 

•  Local Exhaust Ventilation (LEV), extraction at source; 

•  Worker enclosures (WE), i.e. physical separation of workers in an enclosure or control room; 

•  Respiratory Protective Equipment (RPE); 

•  General Dilution Ventilation (GDV); 

•  Organisational & hygiene measures (OH). 

For  reduction  of  fugitive  emission  (e.g.  in  coke  plants  or  in  the  petroleum  sector)  other  types  of 
measures such as improved valves, pumps, etc. are considered. 

iv. 

RMMs effectiveness 

Every  RMM  has  a  different  level of  effectiveness  in  reducing  the  workers  exposure  to  the  substances. 
The percentage reduction in exposure due to each type of RMM used in the analysis is shown below.  

Table 40: Percentage reduction in exposure achieved with RMM 

Type of RMM 

Discontinuation 

Substitution possible 

Substitution not possible 

Rework  

Full enclosure 

Partial enclosure 

Open hood 

No LEV 

Pressurised or sealed 

Simple enclosed cab 

No enclosure 

Breathing apparatus 

HEPA (high efficiency particulate air) filter 

86 

% reduction in exposure 

100% 

100% 

0% 

50% 

99.5% 

90% 

80% 

0% 

99.5% 

80% 

0% 

99.5% 

95% 

 
 
Simple mask 

No mask 

Organisational measures 

No organisational measures 

General dilution ventilation 

No general ventilation 

Source: COWI (2019) 

60% 

0% 

30% 

0% 

30% 

0% 

v. 

RMMs costs 

Table 41: Cost of various RMMs in € 

Size of company 

Small 
2 workers exposed 
Exposed workers on 1 machine 

Medium 
27 workers exposed 
14 machines 

Large 
75 workers 
40 machines 

Type of RMM 

One-off 
2019 

Lifespan 
years 

Recurrent 
(% of one-
off) 

One-off 
2019 

Lifespan 
years 

Recurrent 
(% of one-
off) 

One-off 
2019 

Lifespan 
years 

Recurrent 
(% of one-
off)) 

RWK: Rework 

25,000 

350,000 

1,000,000 

LEV 3: Full 
enclosure 

LEV2: Partial 
enclosure 

LEV1: Open 
hood 

WE 2: 
Pressurised or 
sealed 

WE 1: Simple 
enclosed cab  

45,000 

20 

10% 

440,000 

20 

10% 

1,700,000 

20 

10% 

30,000 

20 

10% 

240,000 

20 

10% 

650,000 

20 

10% 

7,000 

20 

10% 

90,000 

20 

10% 

260,000 

20 

10% 

30,000 

20 

10% 

240,000 

20 

10% 

650,000 

20 

10% 

7,000 

20 

10% 

90,000 

20 

10% 

260,000 

20 

10% 

RPE 3: Breathing 
apparatus 

2,600 

RPE 3a: Powered 
helmets or full 

2,000 

2 

3 

1,000% 

35,000 

30% 

27,000 

2 

3 

1,000% 

100,000 

30% 

40,000 

2 

3 

1,000% 

30% 

87 

 
 
 
 
 
 
 
 
 
 
 
 
face mask 

RPE2: HEPA filter 

300 

RPE 1: Simple 
mask 

500 

Mask: 1 
month, 
Filter: 1 
month 

Not 
relevant, 
1 per day 

50% 

4,000 

7,000 

Not 
relevant 
but one-off 
costs 2019 
incurred 
every year 

Mask: 1 
month, 
Filter: 1 
month 

Not 
relevant, 
1 per day 

50% 

11,000 

20,000 

Not 
relevant 
but one-off 
costs 2019 
incurred 
every year 

Mask: 1 
month, 
Filter: 1 
month 

Not 
relevant, 
1 per day 

50% 

Not 
relevant 
but one-off 
costs 2019 
incurred 
every year 

OH 1: 
Organisational 
measures 

GDV 1: General 
dilution 
ventilation 

2,000 

50% 

27,000 

50% 

75,000 

50% 

6,000 

20 

30% 

40,000 

20 

30% 

100,000 

20 

30% 

Source: COWI (2019) 

vi. 

Sectoral characteristics that determine suitability of RMMs 

For sectors or subsectors, where specific information on RMMs to be applied is not known, the likelihood 
model determines the suitability of RMMs on the basis of sectoral characteristics. 

The amount of exposure is split into work where the worker is exposed to the substance for less than an 
hour  a  day  and  for more  than  an  hour  a  day. This  also  equates  to exposure  for  more or  less  than 2.5 
days/month. Many production activities only occasionally use the substances. Where the exposure is less 
than an hour a day, it is acceptable, and often more cost effective, to use personal protective equipment 
(PPE) such as masks with filters or breathing apparatus.  

The form of substance to which workers are exposed varies considerably from dust and fibres to vapour, 
fumes, gas, mist and aerosol. Again, the form of substance has a direct bearing on the types of RMM that 
are suitable. For example, general dilution ventilation is not advised for removing dust as it tends to stir 
it up and spread it around. For this analysis, the substance form is split into two types: dust which also 
includes fibres; and gas which includes all the other types.  

The extent of the spread is the final characteristic that affects the choice of RMM and this is split into 
three  types:  local,  diffuse  and  peripheral.  Local  means  the  dust  or  gas  is  created  around  a  specific 
machine  and  often  means  that  highly  targeted  ventilation  can  effectively  remove  the  chemical.  Other 
processes  spread  the  substance  over  a  wider  area  and  this  is  known  as  diffuse.  In  this  case,  dilution 
ventilation,  workers  enclosures  or  full  enclosures  are  more  suitable,  the  choice  depending  upon  the 
decrease  in  exposure  required.  Peripheral  means  that  the  substance  spreads  more  widely  and  cause 
exposure  to  workers  beyond  the  area  where  the  substance  is  being  worked.  This  means  that 
administrators, managers and sales staff may be exposed. 

88 

 
 
 
 
 
 
In  the  table  below,  the  types  of  RMM  that  are  suitable  or  not  for  each  amount  of  exposure,  form  of 
substance and extent of spread are shown. These values were built into the cost model. 

Table 42: Suitability of various RMMs to amount of exposure, form of the substance and extent of 
spread 

Type of RMM 

<1h 

>1h 

Dust 

Gas 

Local 

Diffuse 

Peripheral 

Y 

Y 

Y 

Y 

Y 

Y 

N 

N 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

N 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Discontinuation & 
Substitution 

Rework 

Full enclosure 

Partial enclosure 

Open hood 

No LEV 

Pressurised or 
sealed 

Simple enclosed cab 

No enclosure 

Breathing apparatus 

HEPA filter 

Simple mask 

No mask 

Organisational 
measures 

No organisational 
measures 

General dilution 
ventilation 

No general 
ventilation 

Source: COWI (2019) 

Y 

Y 

Y 

Y 

Y 

Y 

N 

N 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

N 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

N 

N 

N 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

N 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

N 

Y 

89 

 
 
 
2.2.  Estimation of the costs of sampling and analysis 

The costs of monitoring air concentrations (sampling and analysis) are estimated separately to the core 
model on the basis of data for several Member States. 

The model for costs of sampling and analysis was developed as part of the CMD 3 where information of 
time  used  for  undertaking  the  sampling  campaign  and  salary  costs  in  various  MS  were  collected.  The 
model  has  in  this  project  been  updated  with  information  on  costs  of  analysis  from  an  international 
laboratory. It is  assumed that  the  costs of analysis is the same  across the  EU, whereas the  salaries  for 
undertaking the sampling varies. See detailed tables in COWI (2019)107.  

3.  ANALYTICAL CHALLENGES 

However, this cost-benefit analyses poses numerous challenges, including:  

  Additional  health  endpoints:  when  considering  the  disease  burden,  only  a  limited  number  of 
cancer and other adverse health effects endpoints have been considered. However, workers may 
develop additional types of cancer and diseases at higher exposure levels than the doses for the 
most sensitive endpoints. Those other cancers or adverse health effects, that will be prevented 
as  well,  could  not  be  taken  into  account  when  calculating  in  particular  the  benefits  of  the 
proposed OELs, leading to an underestimation of the potential benefits. 

  Current  number  of  workers  exposed:  for  some  of  the  substances  considered  in  this  impact 
assessment, the estimated workforce is subject to some uncertainty. This uncertainty could lead 
to  over-  or  underestimate  the  number  of  workers  exposed  to  these  substances  and  impact 
therefore the cost and benefit estimates.  

  Future trends: the exposed workforce and concentration levels are subject to assumptions that 
vary  depending  on  the  substances.  For  some  substances,  it  is  assumed  that  the  exposed 
workforce  and  concentrations  will  remain  unchanged  over  the  next  60  years  while  for  other 
substances, they are assumed to decrease gradually by 2% per year over the same period. It is 
however very challenging to anticipate the technological and market developments over such a 
long period. These projected trends in average exposure levels and number of workers exposed 
may bias the estimated costs and benefits downward or upward.  

  Available epidemiologic evidence: the available epidemiologic evidence is scarce and not always 
sufficiently  robust,  affecting  the  reliability  of  the  derived  estimates  for  the  number  of  cancer 
registrations and deaths. It can therefore be difficult to establish a causal relationship between 
cancer  cases  and  exposure  to  a  specific  carcinogen.  Moreover,  occupational  cancers  may 
develop decades after exposures – including during retirement – complicating the possibility of 
identifying  a  causal  link.  As  a  result,  it  is  more  likely  that  the  health  benefits  presented  in  this 
report could be underestimated. 

  Discount  rate:  in  order  to  allow  for  comparison  between  the  monetised  health  benefits  and 
compliance costs, the net present values of the streams of costs and benefits over the 60-year 

107 See footnote 18 

90 

 
 
 
                                                           
period  under  consideration  are  computed.  The  value  reported  in  this  impact  assessment  are 
calculated on the basis of a static discount rate of 4%. This could lead to underestimate both the 
costs and benefits in comparison with a dynamic discount rate of 4% for the first 20 years and 3% 
for the last 40 years.  

  Assessment period: the reference period of 60 years was established both to be consistent with 
the impact assessments for the first three revisions of the CMD and to ensure that the majority 
of the health benefits are taken into account despite the long latency period for some cancers. It 
is however likely that some cases of cancer arise after the end of the assessment period and are 
not be taken into account in this assessment.  

4.  APPROACH TO THE ASSESSMENT OF THE ENVIRONMENTAL IMPACTS 

Potential changes in OELs for the substances considered in this study may subsequently lead to 
additional or lower environmental impact. Many assumptions, which may or may not be realistic, would 
have to be included in an analysis of this environmental impact: 

•  Is the reduction of OELs mainly achieved by increased emissions from ventilation/ exhaust 

increase? 

•  Is air emission controlled and reduced, e.g., by filter systems? 

•  Is removed air integrated into secondary cycles with additional precipitation devices? 

•  Are filters subsequently disposed or treated (e.g., waste incineration)? 

•  Are there water screens established to collect and dispose aerosols from workplace? 

•  What is the link between water screens and effluent water to sewage systems? 

•  What is the current exact exposure scenario and the status of exposure reduction measures in 

place? 

Because of these heterogeneous parameters, no general and realistic calculation on an environmental 
impact is possible. Qualitatively, it is assumed that changes in OEL will have limited consequences on 
environmental exposure and therefore there is only a low-priority need for quantitative consideration 
within the overall impact assessment.  

5. 

CONSULTATION EXERCISE 

This consulation exercice has been developed in annex 2. 

6.  REACH REGITSRATION DOSSIER /CHEMICAL SAFETY REPORTS (CSRS) 

6.1.  Identification of the relevant CSRs 

In an attempt to gain further insight in current risk management measures and actual exposure levels at 
workplaces,  chemical  safety  reports  (CSRs)  submitted  under  Regulation  (EC)  No  1907/2006  were 

91 

 
 
 
assessed. Since CSRs are confidential, ECHA was requested to extract CSRs from registration dossiers for 
a  limited  number  of 25  substances  belonging  to  the three  substances  subject to  this  report  (see  table 
43).  

Upon  this  request,  ECHA  extracted  all  files  attached  in  section  13  of  the  IUCLID  (International  Uniform 
Chemical Information Database) datasets of all registrations for these 25 substances. In some cases, these 
attachments  did  not  represent  complete  CSRs,  but  rather  other  attachments  (e.g.  files  intended  to 
document strictly controlled intermediates for substances registered as intermediates or only part A of 
the  CSR,  which  typically  only  contains  a  statement  that  RMMs  are  implemented  and  communicated). 
Table 43 lists the substances for which such CSRs were requested and the groups to which they belong. 

Table 43: List of substances for which CSRs were requested from ECHA 

Substance 

Benzene 

Crude oil (petroleum) with recycled naphtha, distilled, 
cracked, hydrotreated and hydrodesulfurized 

CAS No. 

Group 

71-43-2; 1076-43-3  Benzene 

1379524-03-4  Benzene 

Distillates (petroleum), full-range straight-run middle 

68814-87-9  Benzene 

Distillates (petroleum), hydrotreated light 

Distillates (petroleum), light thermal cracked, debutanized 
arom. 

Fuels, diesel 

Gasoline 

Kerosine (petroleum) 

Ligroine 

Naphtha (petroleum), full-range straight-run 

Naphtha (petroleum), light catalytic cracked 

Naphtha (petroleum), light steam-cracked 

Solvent naphtha (petroleum), heavy arom. 

Stoddard solvent 

Acrylonitrile 

Nickle monoxide 

Nickel sulphide 

Nickel sulphate 

64742-47-8  Benzene 

68955-29-3  Benzene 

68334-30-5  Benzene 

86290-81-5  Benzene 

8008-20-6  Benzene 

8032-32-4  Benzene 

64741-42-0  Benzene 

64741-55-5  Benzene 

64742-83-2  Benzene 

64742-94-5  Benzene 

8052-41-3  Benzene 

107-13-1  Acrylonitrile 

1313-99-1  Nickel compounds 

16812-54-7  Nickel compounds 

7786-81-4; 10101-97-0 
10101-98-1 

Nickel compounds 

92 

 
 
Substance 

CAS No. 

Group 

[Carbonato(2-)]tetrahydroxytrinickel 

12607-70-4  Nickel compounds 

Nickel dichloride 

Nickel dihydroxide 

Nickel dinitrate  

Trinickel disulphide 

Nickel bis(sulphamidate) 

Nickel di(acetate) 

Source: ECHA - COWI (2019) 

7718-54-9; 7791-20-0  Nickel compounds 

12054-48-7  Nickel compounds 

13138-45-9; 13478-00-7  Nickel compounds 

12035-72-2  Nickel compounds 

547-67-1  Nickel compounds 

373-02-4; 6018-89-9  Nickel compounds 

Data  were  extracted  in  November  2018.  All  files  received  from  ECHA  were  evaluated  in  a  secure  IT 
environment. 

Under  the  REACH  Regulation,  substances  can  be  registered  with  a  full  registration  (FULL)  or  an 
intermediate  registration  (INT),  if  the  substance  is  exclusively  handled  under  strictly  controlled 
conditions.  In  addition,  registrations  are  often  submitted  by  consortia  of companies  with  a  single  lead 
company (LEAD) generally submitting the complete CSR and all the members of such a joint submission 
(MEMBER) often only attaching Part A of the CSR. 

6.2.  Information of the CSR 

While all substances  are  registered, a registration may  or may not  contain a complete  CSR. Therefore, 
the  attachments  extracted  by  ECHA  were  further  analysed  to  establish  whether  these  constituted 
complete  CSRs  or  other  files.  While  the  LEAD  FULL  registration  is  generally  expected  to  contain  the 
complete  CSR,  members  of  a  joint  submission  can  chose  to  submit  an  additional  CSR,  e.g.  with  uses 
specific to their company or its downstream users that are not covered by the CSR of the lead company. 
For  most  of  the  substances  only  the  LEAD  FULL  CSR  have  been  extracted;  for  many  of  the  substance 
supplemented with a number of appendixes.  

The following table summarises the information on CSRs available for evaluation.  

Table 44: Availability of CSRs for evaluation 

Substance 

Benzene 

Crude oil (petroleum) with recycled naphtha, 
distilled, cracked, hydrotreated and 
hydrodesulfurized 

Distillates (petroleum), full-range straight-run 
middle 

CAS No.  CSR availability  

71-43-2; 1076-43-3  4 example CSRs + 2 CSAs 

1379524-03-4  No CSRs - CSRs not needed 

68814-87-9  1 CSR + many appendices 

93 

 
 
Substance 

CAS No.  CSR availability  

Distillates (petroleum), hydrotreated light 

64742-47-8  2 CSRs. Part A 

Distillates (petroleum), light thermal cracked, 
debutanized arom. 

68955-29-3  1 CSR + many appendices 

Fuels, diesel 

Gasoline 

Kerosine (petroleum) 

Ligroine 

68334-30-5  1 CSR + many appendices 

86290-81-5  1 CSR + many appendices 

8008-20-6  1 CSR + many appendices 

8032-32-4  1 CSR + many appendices 

Naphtha (petroleum), full-range straight-run 

64741-42-0  1 CSR + many appendices 

Naphtha (petroleum), light catalytic cracked 

64741-55-5  1 CSR 

Naphtha (petroleum), light steam-cracked 

64742-83-2  1 CSR 

Solvent naphtha (petroleum), heavy arom. 

64742-94-5  1 CSR 

Stoddard solvent 

Acrylonitrile 

Nickle monoxide 

Nickel sulphide 

Nickel sulphate 

8052-41-3  1 CSR 

107-13-1  1 CSR 

1313-99-1  1 CSR 

16812-54-7  1 CSR 

7786-81-4; 10101-97-0 
10101-98-1 

1 CSR 

[Carbonato(2-)]tetrahydroxytrinickel 

12607-70-4  1 CSR 

Nickel dichloride 

Nickel dihydroxide 

Nickel dinitrate  

Trinickel disulphide 

Nickel bis(sulphamidate) 

Nickel di(acetate) 

Source: ECHA - COWI (2019) 

7718-54-9; 7791-20-0  1 CSR 

12054-48-7  1 CSR 

13138-45-9; 13478-00-7  1 CSR 

12035-72-2  1 CSR 

547-67-1 

Inactive registration. No CSR 

373-02-4; 6018-89-9  1 CSR 

The uses of the substance, occupational exposure associated with these uses as well as risk management 
measures and operational conditions were considered. These data were used in the assessments of the 
chemical agents documented in the separate substance reports.  

94 

 
 
95 

 
 
 
 
Annex 5: National OELs  

Acrylonitrile 

Table 45: National OELs for acrylonitrile within the EU Member States and other non-EU 
countries 

Member State 

OEL 
[mg/m³, (ppm)] 

Specification 
of OEL 

STEL 
[mg/m3, (ppm)] 

Specification of STEL 

Austria1,5 

Belgium1,5 

Bulgaria 

Croatia 

Cyprus 

4.5 (2.0)# 

4.4 (2.0) 

–Sk 

–Sk 

- 

- 

- 

18.0 (8.0) 

–Sk 

- 

- 

- 

- 

Czech Republic5 

2.0 

–Sk 

6.0 

–Sk 

–Sk 

–Sk 
–Sk 

–maximum allowable 
concentration 

Denmark1,5 

Estonia5 

Finland1,5 

France1,5 

Germany1,2,5 

Greece5 

Hungary1,3 

Ireland1,5 

Italy 

Latvia1,5 

Lithuania5 

Luxembourg 

Malta 

4.0 (2.0) 

4.5 (2.0) 

4.4 (2.0) 

4.5 (2.0) 

2.6 (1.2)§ 
0.26 (0.12)$ 

4.5 (2.0) 

4.3 

4.5 (2.0) 

- 

0.5 

4.5 (2.0) 

- 

- 

Netherlands 

Set by the company 

Poland1,5 

Portugal5 

2.0 

4.4 (2.0) 

–Sk 

96 

8.0 (4.0) 

13.0 (6.0) 

8.8 (4.0) 

–Sk 

32.5 (15.0) 

20.8 (9.6)§ 
2.1 (0.96)$ 

–Sk 
–Sk 

- 

- 

- 

- 

- 

13.0 (6.0) 

- 

- 

- 

10.0 

- 

–Sk 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Member State 

OEL 
[mg/m³, (ppm)] 

Specification 
of OEL 

STEL 
[mg/m3, (ppm)] 

Specification of STEL 

–Sk 

–Sk 

–Sk 

–Sk, S 

–Sk 

–Sk 

–Sk 

Romania1,5 

Slovakia5 

Slovenia5 

Spain1,5 

Sweden1,5 

United Kingdom1 

5.0 (2.3) 

7.0 (3.0) 

7.0 

4.4 (2.0) 

4.5 (2.0) 

4.4 (2.0) 

RAC4 

1.0 (0.45) 

Non-EU countries 

Australia1,5 

Brazil6 

4.3 (2.0) 

35.0 (16.0) 

Canada, Ontario1 

(2.0) 

Canada, Québec1 

4.3 (2.0) 

China5 

India7 

Japan1 

Japan - JSOH1 

South Korea1 

Switzerland1 

USA, ACGIH5,8 

USA, NIOSH1,** 

USA, OSHA1,5 

2.0 (0.92) 

–maximum allowable 
concentration 

4.5 (2.0) 

4.3 (2.0) 

4.3 (2.0) 

4.5 (2.0) 

4.5 (2.0) 

4.3 (2.0) 

2.2 (1.0) 

4.4 (2.0) 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

10.0 (4.6) 

- 

28.0 

- 

13.0 (6.0) 

- 

4.0 (1.8) 

- 

(10.0) 

- 

- 

- 

- 

- 

- 

- 

- 

22.0 (10.0) 

22.0 (10.0) 

–Sk 

–Sk 

RAC = Committee for Risk Assessment 
JSOH = Japan Society for Occupational Health 
ACGIH = American Conference of Governmental Industrial Hygienists 
OSHA = Occupational Safety and Health Administration 
NIOSH = National Institute for Occupational Safety and Health 
Sk = skin notation assigned 
- not established/assigned 
# TRK value (“Technische Richtkonzentration”, Technical Guidance Concentrations), based on technical feasibility 
* classified as C1A and C1B 
† binding limit value 
~ restrictive statutory limit value 
§ Workplace exposure concentration corresponding to the proposed tolerable cancer risk 4:1,000 
$ Workplace exposure concentration corresponding to the proposed preliminary acceptable cancer risk 4:100,000 
+ Reference value corresponding to an individual excess lifetime risk of cancer 10-3 
++ Reference value corresponding to an individual excess lifetime risk of cancer 10-4 
** NIOSH indicates a time-weighted average concentration for up to a 10-hour workday during a 40-hour workweek. 
Data taken from:  

97 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) GESTIS– International Limit Values 
http://limitvalue.ifa.dguv.de/ accessed on 17.10.2018 
2: AGS, Ausschuss für Gefahrstoffe (2010) Begründung zu Expositions-Risiko-Beziehung für Acrylnitril in BekGS 910. Available at: 
https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-Regeln/Regelwerk/TRGS/pdf/910/910-
acrylnitril.pdf?__blob=publicationFile, accessed on 18.10.2018 
3: Hungary (2018) Decree on chemical safety at workplaces 25/2000. (IX. 30.). Available at: 
http://njt.hu/cgi_bin/njt_doc.cgi?docid=48596.358186 , accessed on 19.10.2018 
4: RAC (2018) Opinion on scientific evaluation of occupational exposure limits for acrylonitrile. ECHA/RAC/ O-0000001412-86-188/F. 
Adopted 9 March 2018. Available at: https://echa.europa.eu/documents/10162/13641/acrylonitrile_opinion_en.pdf/102477c9-
a961-2c96-5c4d-76fcd856ac19, accessed on 18.10.2018 
5: RAC (2018) ANNEX 1 Background document in support of the Committee for Risk Assessment (RAC) evaluation of limit values for 
acrylonitrile in the workplace. ECHA/RAC/ O-0000001412-86-188/F. Available at: 
https://echa.europa.eu/documents/10162/13641/acrylonitrile_bg_annex1_en.pdf/600bc12b-f2b4-16f6-0164-25153b48743d, 
accessed on 18.10.2018 
6: Brazil, Tabela de Limites de Tolerância in Annex No.11 of Regulatory Standard NR N-15, Available at: 
http://www.guiatrabalhista.com.br/legislacao/nr/nr15_anexoXI.htm, accessed on 19.10.2018 
7: India, Factories Act, 1948, 41-F Permissible Limits of Exposure of Chemical and Toxic Substance. Available at: 
http://dgfasli.nic.in/html/factyact/csch2.htm, accessed on 19.10.2018 
8: ACGIH, American Conference of Governmental Industrial Hygienists (2018), TLVs and BEIs Based on the Documentation of the 
Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. Notice of Intended Changes 

Table 46: Member states with OELs for acrylonitrile higher than the envisaged scenarios 

Target OEL mg/m3 

Member States who would need to 
introduce or alter legislation 

Number of countries required 
to transpose 

0.5 

1 

2 

4.5 

All Member States except Latvia 

All Member States except Latvia 

All Member States except Czech 
Republic, Poland and Latvia 

SK, SL, RO 

27 

27 

25 

3 

98 

 
 
 
 
 
Nickel compounds 

Table 47: National OELs for nickel compounds within the EU Member States and other non-EU countries 

Country/ 
Organisation 

Soluble 
inorganic 
Ni 
compoun
ds 

Insoluble 
inorganic 
Ni 
compoun
ds 

Ni metal 

Ni 
compoun
ds 

Nickel 
monoxide 

Nickel 
sulphide 

Nickel 
sulphate 

Nickel 
dichloride 

Nickel 
dihydroxi
de 

Trinickel 
disulphid
e 

Nickel 
dioxide 

Ni 
trioxide 

Nickel 
carbonat
e 

0.5 (I)# S 

0.5 (I)# S 

0.5 (I)# S 

0.5 (I)# S 

0.5 (I)# S 

0.5 (I)# S 

0.5 (I)# S 

0.5 (I)# S 

0.5 (I)# S 

Austria1,2,3 

0.05 (I)# S 

0.5 (I)# S 

0.5 (I)# S 

Belgium1,2,4 

Bulgaria5 

Croatia6 

Cyprus37 

Czech  

Republic37 

0.1* 

- 

0.2* 

- 

0.01* 

0.05* 

- 

- 

- 

- 

1.0* 

0.05* 

- 

- 

- 

Denmark1,2,7 

0.01* 

0.05* 

0.05* 

Estonia37 

Finland1,2,8 

- 

- 

- 

0.05 (I) 

0.05 (I) 

0.01 (R) 

- 

- 

0.05* 

- 

- 

- 

- 

- 

- 

- 

0.01 (R) 

0.01 (R) 

France1,2,9,### 

Germany1,2,10,11 

- 

- 

- 

- 

1.0* 

1.0* 

0.006 (R) 

0.030 (I) 

- 

- 

- 

- 

- 

- 

- 

- 

1.0∞,* 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.1* 

- 

- 

- 

- 

- 

- 

0.05 (I) 

0.05 (I) 

0.05 (I) 

0.05 (I) 

0.05 (I) 

0.05 (I) 

0.01 (R) 

0.01 (R) 

0.01 (R) 

0.01 (R) 

0.01 (R) 

0.01 (R) 

- 

- 

1.0* 

- 

1.0* 

- 

1.0* 

- 

0.1* 

- 

99 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

1.0* 

- 

- 

- 

- 

- 

- 

- 

- 

0.05 (I) 

0.01 (R) 

1.0* 

- 

Ni matte 
roasting‡ 
or 
smelting 
dusts‡‡ 

- 

- 

- 

- 

- 

- 

- 

- 

- 

1.0‡,* 

- 

 
 
 
 
Greece37 

- 

- 

- 

Hungary1,2,12 

0.1M,* S 

0.1M,* S 

0.1M,* S 

Ireland1,2,13 

Italy37 

Latvia1,2,14 

Lithuania15 

Luxembourg16 

Malta37 

0.1* 

- 

0.05* 

0.1* S 

- 

- 

0.5* 

- 

0.05* 

- 

- 

- 

0.5* S 

- 

0.05* 

0.5* S 

- 

- 

Netherlands2,17 

0.1##,* 

0.1##,* 

0.1##,* 

0.013 (R)§ 

0.006 (R)$ 

0.001 (R)$ 

- 

- 

- 

- 

0.05* 

- 

- 

- 

- 

0.25M,* 

0.25M,* 

- 

0.1* 

- 

0.1* 

Poland9 

Portugal37 

Romania1,2,19 

Slovakia20 

Slovenia21 

Spain1,2,22 

- 

- 

- 

- 

- 

- 

- 

- 

0.5 (I) S 

0.5 (I)* S 

0.5 (I) S 

0.5 (I) S 

0.006 (R) Sk 

- 

- 

- 

- 

0.1* S 

0.2* S 

1.0* S 

0.1* S 

0.1* S 

0.1* S 

Sweden1,2,23 

- 

- 

0.5 (T) S 

0.1  (T) S 

- 

- 

- 

United  

0.1M,* Sk 

0.5M,* Sk 

0.5M,* Sk 

- 

0.1M,* Sk 

0.1M,* Sk 

0.1M,* Sk,S 

Kingdom1,2,24 

100 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.1M,* S 

0.1M,* S 

0.1M,* S 

0.1M,* S 

0.1M,* S 

0.1M,* S 

0.1M,* S 

0.1M,* S 

0.1M,* S 

- 

- 

0.05* 

0.1* S 

- 

- 

- 

- 

- 

- 

- 

- 

0.05* 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.01* 

0.1* S 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.05* 

0.01* 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.05* 

0.1* S 

- 

- 

- 

- 

- 

- 

0.5 (I) S 

- 

0.1* S 

0.1* S 

0.1* S  

0.01 (T) S 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.1M,* Sk 

0.1M,* Sk 

0.1M,* Sk 

- 

- 

- 

- 

- 

- 

- 

- 

0.1* S 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

 
 
 
0.03 (I) S 

0.03 (I) S 

- 

- 

0.005 (R) S 

0.005 (R) S 

RAC25 

- 

Non-EU countries 

Australia1,26 

Brazil27 

0.1* S 

- 

- 

- 

- 

1.0* S 

- 

Canada,  

0.1 (I) 

0.2 (I) 

1.0 (I) 

Ontario1,28 

Canada,  

Québec1,29 

China1,30 

India31 

Japan1 

0.1* 

1.0* 

1.0* 

0.5* 

- 

1.0* 

- 

0.1+,* 

0.1+,* 

1.0* 

- 

- 

Japan - JSOH1,32 

0.01 (T) 

0.1 (T) 

1.0* 

South Korea1 

0.1* 

0.5* 

1.0* 

Switzerland1,2,33 

0.05 (I) S 

0.05 (I) S 

0.5 (I) S 

USA, ACGIH34 

0.1 (I) 

0.2 (I) 

1.5 (I) 

USA, NIOSH1,2,35,*** 

0.015* 

0.015* 

0.015* 

USA, OSHA1,2,36 

1.0* 

1.0* 

1.0* 

RAC = Committee for Risk Assessment 
JSOH = Japan Society for Occupational Health 
ACGIH = American Conference of Governmental Industrial Hygienists 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

1.0* S 

- 

- 

- 

- 

- 

- 

- 

1.0∞,* 

0.05 (I) S 

0.05 (I) S 

- 

- 

- 

- 

- 

- 

- 

0.1* (NiCl2) 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.1 (I) 

- 

- 

- 

- 

- 

0.1* 

- 

0.1 (I) 

0.015* 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

1.0‡,* 

- 

- 

- 

0.01++,* 

0.001+++,* 

- 

- 

- 

0.015‡,* 

- 

- 

- 

- 

0.1 (I) 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

101 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OSHA = Occupational Safety and Health Administration 
NIOSH = National Institute for Occupational Safety and Health 
(I) = inhalable; (R) = respirable; (T) = total dust; 
* differentiation in inhalable, respirable or total dust is not made 
S = notation for sensitisation assigned 
Sk = skin notation assigned 
‡ matte roasting 
‡‡ smelting dusts 
- no value available  
# TRK value (“Technische Richtkonzentration”, Technical Guidance Concentrations), based on technical feasibility 
### For France indicative limit values (not legally binding) are given. 
∞ Nickel sulphide, fume and dust, as Ni, roasting 
§ Workplace exposure concentration corresponding to the proposed tolerable cancer risk 4:1,000 
$ Workplace exposure concentration corresponding to the proposed preliminary acceptable cancer risk 4:10,000 (6 µg/m³) or 4:100,000 (1 µg/m³) 
## Not legally applicable since 01.01.2007 
M Maximum exposure limit (MEL) or Maximum Allowable Concentration (MAC) 
+ The value is applied to workplaces using powder substances. 
++ Reference value corresponding to an individual excess lifetime risk of cancer 10-3 
+++ Reference value corresponding to an individual excess lifetime risk of cancer 10-4 
*** NIOSH indicates a time-weighted average concentration for up to a 10-hour workday during a 40-hour workweek. 
Sources:  
1: Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) GESTIS– International Limit Values.  Available at: http://limitvalue.ifa.dguv.de/ accessed on 17.10.2018 
2: RAC, Committee for Risk Assessment (2018) ANNEX 1 Background Document in support of the Committee for Risk Assessment (RAC) for evaluation of limit values for nickel and its compounds in the workplace. Available at: 
https://echa.europa.eu/documents/10162/13641/nickel_bg_annex1_en.pdf/12d24cbf-8f7e-0f1f-64c3-4992df4d00e8, accessed on 19.10.2018 
3: Austria (2018) Grenzwerteverordnung 2018 – GKV 2018. Available at: https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20001418, accessed on 27.11.2018 
4: Belgium, (2018) List of limit values. Available at: http://www.werk.belgie.be/moduleDefault.aspx?id=1958, accessed on 19.12.2018 
5: Bulgaria, (2018) List of limit values. Available at: https://www.lex.bg/laws/ldoc/2135477597, accessed on 30.11.2018 
6: Croatia, (2018) List of limit values. Available at: https://narodne-novine.nn.hr/clanci/sluzbeni/2018_10_91_1774.html, accessed on 30.11.2018 
7: Denmark, (2018) List of limit values (HTP). Available at: https://amid.dk/da/regler/bekendtgoerelser/graensevaerdier-stoffer-materialer-655/bilag-2/, accessed on 30.11.2018 
8: Finland, (2018) List of limit values (HTP). Available at: http://julkaisut.valtioneuvosto.fi/bitstream/handle/10024/160967/STM_09_2018_HTParvot_2018_web.pdf?sequence=1&isAllowed=y, accessed on 26.11.2018 
9: France, (2018) List of limit values. Available at: http://www.inrs.fr/media.html?refINRS=outil65, accessed 19.12.2018 
10: Germany, Ausschuss für Gefahrstoffe (AGS) (2018) Technische Regeln für Gefahrstoffe – Arbeitsplatzgrenzwerte (TRGS 900). Ausgabe: Januar 2006. BArBl Heft 1/2006 S. 41-55. Geändert und ergänzt: GMBl 2018 S.542-
545[Nr.28] (v.07.06.2018). Available at: https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-Regeln/Regelwerk/TRGS/pdf/TRGS-900.pdf?__blob=publicationFile&v=11, accessed on 19.10.2018 
11: Germany, Ausschuss für Gefahrstoffe (AGS) (2017) Begründung zu Nickelverbindungen in TRGS 910. Ausgabe: Juni 2017. Available at: https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-
Regeln/Regelwerk/TRGS/pdf/910/910-nickel.pdf?__blob=publicationFile&v=3, accessed on 19.10.2018 
12: Hungary, (2018) Decree on chemical safety at workplaces 25/2000. (IX. 30.). Available at: https://net.jogtar.hu/getpdf?docid=a0000025.eum&targetdate=&printTitle=25/2000.+%28IX.+30.%29+E%C3%BCM-
SzCsM+egy%C3%BCttes+rendelet, accessed on 27.11.2018 
13: Ireland, Health and Safety Authority (2018) Code of Practice. Available at: 
https://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/2018_Code_of_Practice_for_the_Chemical_Agents_Regulations.html, accessed on 19.10.2018 
14: Latvia, (2018), List of limit values. Available at: https://likumi.lv/wwwraksti/2007/080/B080/KN325P1_13.07.2018.DOC, accessed on 19.12.2018 
15: Lithuania, (2018) List of limit values. Available at: https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.405920/qmafVPRFbo?positionInSearchResults=0&searchModelUUID=ae46f2fa-df10-44ca-a17c-8e225bec6956, accessed 
on 06.12.2018 
16: Luxembourg, (2018) List of limit values. Available at: http://legilux.public.lu/eli/etat/leg/rgd/2018/07/20/a684/jo, accessed on 30.11.2018 
17: Netherlands, (2018): List of limit values. Available at: https://wetten.overheid.nl/BWBR0008587/2018-10-01, accessed on 30.11.2018 

102 

 
18: Poland, (2018) List of limit values. Available at: http://prawo.sejm.gov.pl/isap.nsf/download.xsp/WDU20180001286/O/D20181286.pdf, accessed on 19.10.2018 
19: Romania, (2018) List of limit values. Available at: http://www.mmuncii.ro/j33/images/Documente/Legislatie/HG584-2018.pdf, accessed 19.12.2018 
20: Slovakia (2018) List of limit values. Available at: http://www.epi.sk/print/zz/2006-356.htm, accessed on 30.11.2018 
21: Slovenia (2018) List of limit values. Available at: http://www.pisrs.si/Pis.web/pregledPredpisa?id=PRAV4030 , accessed on 30.11.2018 
22: Spain, (2018) List of limit values (VLA). Available at: http://www.insht.es/InshtWeb/Contenidos/Documentacion/LEP%20_VALORES%20LIMITE/Valores%20limite/Limites2018/Limites2018.pdf, accessed on 19.10.2018 
23: Sweden, Arbetsmiljöverket (2018) Hygieniska gränsvärden (AFS 2018:1). Available at: https://www.av.se/arbetsmiljoarbete-och-inspektioner/publikationer/foreskrifter/hygieniska-gransvarden-afs-20181-foreskrifter/, 
accessed on 27.11.2018 
24: United Kingdom, Health and Safety Executive, EH40/2005 Workplace exposure limits, Available at: http://www.hse.gov.uk/pubns/priced/eh40.pdf, accessed on 27.11.2018 
25: RAC, Committee for Risk Assessment (2018) Opinion on scientific evaluation of occupational exposure limits for nickel and its compounds. ECHA/RAC/ A77-O-0000001412-86-189/F. Adopted 9 March 2018. Available at: 
https://echa.europa.eu/documents/10162/13641/nickel_opinion_en.pdf/9e050da5-b45c-c8e5-9e5e-a1a2ce908335, accessed on 19.10.2018 
26: Australia, Safe Work Australia (2018) Workplace exposure standards for airborne contaminants. Available at: https://www.safeworkaustralia.gov.au/system/files/documents/1804/workplace-exposure-standards-airborne-
contaminants-2018_0.pdf, accessed on 27.11.2018 
27: Brazil, Tabela de Limites de Tolerância in Annex No.11 of Regulatory Standard NR N-15, Available at: http://www.guiatrabalhista.com.br/legislacao/nr/nr15_anexoXI.htm, accessed on 19.10.2018 
28: Canada, Ontario, (2018) Current Occupational Exposure Limits for Ontario Workplaces Required under Regulation 833. Available at: https://www.labour.gov.on.ca/english/hs/pubs/oel_table.php, accessed on 27.11.2018 
29: Canada, Québec, (2018) Regulation respecting occupational health and safety, chapter S-2.1, r. 13. Available at: http://legisquebec.gouv.qc.ca/en/pdf/cr/S-2.1,%20R.%2013.pdf, accessed on 27.11.2018 
30: China (2007), List of limit values. Available at: http://www.nhfpc.gov.cn/zwgkzt/pyl/200704/38838/files/5eb946b479124c32a6ebb8c49f483c24.pdf, accessed on 19.12.2018 
31: India, Factories Act, 1948, 41-F Permissible Limits of Exposure of Chemical and Toxic Substance. Available at: http://dgfasli.nic.in/html/factyact/csch2.htm, accessed on 19.10.2018 
32: Japan – JSOH, (2018) Recommendation of Occupational Exposure Limits. Available at: https://www.sanei.or.jp/images/contents/310/OEL.pdf, accessed on 19.10.2018 
33: Switzerland, Suva (2018) Aktuelle MAK- und BAT-Werte. Available at: https://www.suva.ch/de-CH/material/Richtlinien-Gesetzestexte/grenzwerte-am-arbeitsplatz-aktuelle-
werte/#59317A47178F431595269A7BB5018B2A=%3Flang%3Dde-CH, accessed on 19.10.2018 
34: ACGIH, American Conference of Governmental Industrial Hygienists (2018), Threshold Limit Values (TLVs) and Biological Exposure Indices (BEIs) Based on the Documentation of the Threshold Limit Values for Chemical 
Substances and Physical Agents and Biological Exposure Indices. Notice of Intended Changes 
35: USA, NIOSH (2018) Pocket Guide to Chemical Hazards. Available at: https://www.cdc.gov/niosh/npg/npgd0445.html, accessed on 27.11.2018 
36: USA, OSHA (2018) Permissible Exposure Limits / OSHA Annotated Table Z-1. Available at: https://www.osha.gov/dsg/annotated-pels/tablez-1.html, accessed on 27.11.2018 
37: no reply received from a contacted person regarding OELs/STELs  

103 

 
 
 
 
 
 
 
 
104 

 
 
 
 
Table 48: Member states with OELs for nickel compounds higher than the envisaged scenarios 

OLEV options (inhalable) 

MS where current limits are higher 

0.01 mg/m3 

0.03 mg/m3 

0.05 mg/m3 

0.1 mg/m3 

0.5 mg/m3 

1 mg/m3 

AT, BE, BG, CY, CZ, DE, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, RO, SI, SK, UK 

AT, BE, BG, CY, CZ, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, RO, SI, SK, UK 

AT, BE, CY, CZ, EE, EL, ES, FR, HU, IE, IT, LT, LU, MT, NL, PL, PT, RO, SI, SK, UK 

AT, CY, CZ, EE, EL, FR, IT, LU, MT, PL, PT, SI, SK 

CY, CZ, EE, EL, FR, IT, LU, MT, PT, SI 

CY, CZ, EE, EL, IT, LU, MT, PT, SI 

% of MS 

89% 

86% 

75% 

46% 

36% 

32% 

Notes:  The actual OELs in each Member State are complex combination of OELs for nickel compounds, specific nickel compounds, soluble nickel compounds and insoluble nickel compounds 
Croatia, Denmark and Sweden have OELs for some nickel compounds of 0.01mg/m3 

105 

 
 
 
Benzene 

Table 49: National OELs for benzene within the EU Member States and other non-EU countries 

Member State 

OEL  
mg/m³, (ppm) 

Specification 
of OEL 

STEL  
mg/m3, (ppm) 

Specification of STEL 

Austria1,2,3 

Belgium1,4 

Bulgaria5 

Croatia6 

Cyprus 

3.2 (1.0)* 

3.25 (1.0) 

3.25 (1.0) 

3.25 (1.0) 

3.25 (1.0) 

–Sk 

–Sk 

–Sk 

–Sk 

Czech Republic2 

3.0 

12.8 (4.0)* 

–Sk 

- 

- 

- 

- 

10.0 

Denmark1,7 

Estonia2 

Finland1,2,8 

France1,2 

Germany1,2,10 

Greece 

Hungary1,11 

Ireland1,12 

Italy1 

Latvia1,2,13 

Lithuania2,14 

Luxembourg 

Malta 

Netherlands1,16 

Poland1,2,17 

Portugal 

Romania1,2,18 

Slovakia2,19 

Slovenia2,20 

Spain1,2,21 

Sweden1,2,22 

1.6 (0.5) 

–Sk 

3.2 (1.0) 

–Sk 

1.5 (0.5) 

3.25 (1.0) 

3.25 (1.0)~ 

1.9 (0.6)§ 
0.02 (0.006)$ 

–Sk 

–Sk 

–Sk 
–Sk 

9.0 (3.0) 

- 

- 

15.2 (4.8)§ 

–Sk 

–maximum allowable 
concentration 

3.25 (1.0) 

3.0 

3.0 (1.0) 

3.25 (1.0) 

3.25 (1.0) 

3.25 (1.0) 

3.25 (1.0) 

3.25 (1.0) 

0.7 (0.2) 

1.6 

3.25 (1.0) 

3.25 (1.0) 

3.25 (1.0) 

3.25 (1.0) 

3.25 (1.0) 

1.5 (0.5) 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

–Sk 

- 

- 

- 

- 

- 

19.0 (6.0) 

–Sk 

- 

- 

- 

- 

- 

- 

- 

–Sk 

(4.0) 

- 

9.0 (3.0) 

–Sk 

106 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OEL  
mg/m³, (ppm) 

Specification 
of OEL 

STEL  
mg/m3, (ppm) 

Specification of STEL 

Member State 

United Kingdom1,23 

European Union1,2 

RAC24 

Non-EU countries 

Australia25 

Brazil26 

Canada, Ontario1,27 

3.25 (1.0) 

3.25 (1.0) 

0.16 (0.05) 

–Sk 

–Sk 

-Sk 

3.2 (1.0) 

- 

(0.5) 

Canada, Québec1,28 

3.0 (1.0) 

China1,29 

India30 

Japan1 

Japan - JSOH1,31 

South Korea1 

Switzerland1,32 

USA, ACGIH33 

6.0  

1.5 (0.5) 

(10) 

(1.0)+ 
(0.1)++ 

3.0 (1.0) 

1.6 (0.5) 

1.6 (0.5) 

-Sk 

-Sk 

-Sk 

-Sk 

-Sk 

-Sk 

- 

- 

- 

- 

- 

(2.5) 

-Sk 

15.5 (5.0) 

10.0 

-Sk 

7.5 (2.5) 

- 

- 

16.0 (5.0) 

-Sk 

- 

8.0 (2.5) 

-Sk 

USA, NIOSH1,2,34** 

0.32 (0.1) 

USA, OSHA1,2,35 

3.2 (1.0) 

–ceiling limit value (15 
min) 

3.2 (1.0) 

15.0 (5.0) 

RAC = Committee for Risk Assessment 
JSOH = Japan Society for Occupational Health 
ACGIH = American Conference of Governmental Industrial Hygienists 
OSHA = Occupational Safety and Health Administration 
NIOSH = National Institute for Occupational Safety and Health 
Sk = skin notation assigned 
- no value available  
* TRK value (“Technische Richtkonzentration”, Technical Guidance Concentrations), based on technical feasibility 
~ For France, restrictive statutory limit value given. 
§ Workplace exposure concentration corresponding to the proposed tolerable cancer risk 4:1,000 
$ Workplace exposure concentration corresponding to the proposed preliminary acceptable cancer risk 4:100,000 
+ Reference value corresponding to an individual excess lifetime risk of cancer 10-3 
++ Reference value corresponding to an individual excess lifetime risk of cancer 10-4 
** NIOSH indicates a time-weighted average concentration for up to a 10-hour workday during a 40-hour workweek. 
Data taken from:  
1: Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) GESTIS– International Limit Values. 
Available at: http://limitvalue.ifa.dguv.de/, accessed on 17.10.2018 
2: ECHA, European Chemicals Agency (2017) Proposal by the European Chemical Agency (ECHA) in support of occupational exposure 
limit values for benzene in the workplace.  
3: October 2017. Available at: https://echa.europa.eu/documents/10162/214b2029-82fd-1656-1910-3e18d0906999, accessed on 
18.10.20183:  
Austria (2018) Grenzwerteverordnung 2018 – GKV 2018. Available at: 
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20001418, accessed on 27.11.2018 
4: Belgium, (2018) List of limit values. Available at: http://www.werk.belgie.be/moduleDefault.aspx?id=1958, accessed on 19.12.2018 

107 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5: Bulgaria, (2018) List of limit values. Available at: https://www.lex.bg/laws/ldoc/2135477597, accessed on 30.11.2018 
6: Croatia, (2018) List of limit values. Available at: https://narodne-novine.nn.hr/clanci/sluzbeni/2018_10_91_1774.html, accessed on 
30.11.2018 
7: Denmark, (2018) List of limit values (HTP). Available at: https://amid.dk/da/regler/bekendtgoerelser/graensevaerdier-stoffer-
materialer-655/bilag-2/, accessed on 30.11.2018 
8: Finland, (2018) List of limit values (HPT). Available at: 
http://julkaisut.valtioneuvosto.fi/bitstream/handle/10024/160967/STM_09_2018_HTParvot_2018_web.pdf?sequence=1&isAllowed=y, 
accessed on 26.11.2018 
9: France, (2018) List of limit values. Available at: http://www.inrs.fr/media.html?refINRS=outil65, accessed 19.12.2018 
10: Germany, Ausschuss für Gefahrstoffe (AGS) (2012) Begründung zu Expositions-Risiko-Beziehung für Benzol in BekGS 910. Ausgabe: 
November 2012. Available at: https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-Regeln/Regelwerk/TRGS/pdf/910/910-
benzol.pdf?__blob=publicationFile&v=2, accessed on 18.10.2018 
11: Hungary, (2018) Decree on chemical safety at workplaces 25/2000. (IX. 30.). Available at: 
https://net.jogtar.hu/getpdf?docid=a0000025.eum&targetdate=&printTitle=25/2000.+%28IX.+30.%29+E%C3%BCM-
SzCsM+egy%C3%BCttes+rendelet, accessed on 27.11.2018 
12: Ireland, Health and Safety Authority (2018) Code of Practice. Available at: 
https://www.hsa.ie/eng/Publications_and_Forms/Publications/Chemical_and_Hazardous_Substances/2018_Code_of_Practice_for_the
_Chemical_Agents_Regulations.html, accessed on 19.10.2018 
13: Latvia, (2018), List of limit values. Available at: https://likumi.lv/wwwraksti/2007/080/B080/KN325P1_13.07.2018.DOC, accessed 
on 19.12.2018 
14: Lithuania, (2018) List of limit values. Available at: https://e-
seimas.lrs.lt/portal/legalAct/lt/TAD/TAIS.405920/qmafVPRFbo?positionInSearchResults=0&searchModelUUID=ae46f2fa-df10-44ca-
a17c-8e225bec6956, accessed on 06.12.2018 
15: Luxembourg, (2018) List of limit values. Available at: http://legilux.public.lu/eli/etat/leg/rgd/2018/07/20/a684/jo, accessed on 
30.11.2018 
16: Netherlands, (2018): List of limit values. Available at: https://wetten.overheid.nl/BWBR0008587/2018-10-01, accessed on 
30.11.2018 
17: Poland, (2018) List of limit values. Available at: 
http://prawo.sejm.gov.pl/isap.nsf/download.xsp/WDU20180001286/O/D20181286.pdf, accessed on 19.10.2018 
18: Romania, (2018) List of limit values. Available at: http://www.mmuncii.ro/j33/images/Documente/Legislatie/HG584-2018.pdf, 
accessed 19.12.2018 
19: Slovakia (2018) List of limit values. Available at: http://www.epi.sk/print/zz/2006-356.htm, accessed on 30.11.2018 
20: Slovenia (2018) List of limit values. Available at: http://www.pisrs.si/Pis.web/pregledPredpisa?id=PRAV4030, accessed on 
30.11.2018 
21: Spain, (2018) List of limit values (VLA). Available at: 
http://www.insht.es/InshtWeb/Contenidos/Documentacion/LEP%20_VALORES%20LIMITE/Valores%20limite/Limites2018/Limites2018.
pdf, accessed on 19.10.2018 
22: Sweden, Arbetsmiljöverket (2018) Hygieniska gränsvärden (AFS 2018:1). Available at: https://www.av.se/arbetsmiljoarbete-och-
inspektioner/publikationer/foreskrifter/ 
hygieniska-gransvarden-afs-20181-foreskrifter/, accessed on 27.11.2018 
23: United Kingdom, Health and Safety Executive, EH40/2005 Workplace exposure limits, Available at: 
http://www.hse.gov.uk/pubns/priced/eh40.pdf, accessed on 27.11.2018 
24: RAC, Committee for Risk Assessment (2018) Opinion on scientific evaluation of occupational exposure limits for benzene. 
ECHA/RAC/ O-000000-1412-86-187/F. Adopted 9 March 2018. Available at: 
https://echa.europa.eu/documents/10162/13641/benzene_opinion_en.pdf/4fec9aac-9ed5-2aae-7b70-5226705358c7, accessed on 
18.10.2018 
25: Australia, Safe Work Australia (2018) Workplace exposure standards for airborne contaminants. Available at: 
https://www.safeworkaustralia.gov.au/system/files/documents/1804/workplace-exposure-standards-airborne-contaminants-
2018_0.pdf, accessed on 27.11.2018 
26: Brazil, Tabela de Limites de Tolerância in Annex No.11 of Regulatory Standard NR N-15, Available at: 
http://www.guiatrabalhista.com.br/legislacao/nr/nr15_anexoXI.htm, accessed on 19.10.2018 
27: Canada, Ontario, (2018) Current Occupational Exposure Limits for Ontario Workplaces Required under Regulation 833. Available at: 
https://www.labour.gov.on.ca/english/hs/pubs/oel_table.php, accessed on 27.11.2018 
28: Canada, Québec, (2018) Regulation respecting occupational health and safety, chapter S-2.1, r. 13. Available at: 
http://legisquebec.gouv.qc.ca/en/pdf/cr/S-2.1,%20R.%2013.pdf, accessed on 27.11.2018 
29: China (2007), List of limit values. Available at: 
http://www.nhfpc.gov.cn/zwgkzt/pyl/200704/38838/files/5eb946b479124c32a6ebb8c49f483c24.pdf, accessed on 19.12.2018 
30: India, Factories Act, 1948, 41-F Permissible Limits of Exposure of Chemical and Toxic Substance. Available at: 
http://dgfasli.nic.in/html/factyact/csch2.htm, accessed on 19.10.2018 
31: Japan – JSOH, (2018) Recommendation of Occupational Exposure Limits. Available at: 
https://www.sanei.or.jp/images/contents/310/OEL.pdf, accessed on 19.10.2018 
32: Switzerland, Suva (2018) Aktuelle MAK- und BAT-Werte. Available at: https://www.suva.ch/de-CH/material/Richtlinien-
Gesetzestexte/grenzwerte-am-arbeitsplatz-aktuelle-werte/#59317A47178F431595269A7BB5018B2A=%3Flang%3Dde-CH, accessed on 
19.10.2018 

108 

 
33: ACGIH, American Conference of Governmental Industrial Hygienists (2018), TLVs and BEIs Based on the Documentation of the 
Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices. Notice of Intended Changes 
34: USA, NIOSH (2018) Pocket Guide to Chemical Hazards. Available at: https://www.cdc.gov/niosh/npg/npgd0049.html, accessed on 
27.11.2018 
35: USA, OSHA (2018) Occupational Safety and Health Standards 1910.1028. Available at: 
https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10042&p_table=standards, accessed on 27.11.2018 
36: no reply received from a contacted person (if possible contact person from a previous EU project was contacted) regarding 
OELs/STELs  

Table 50: Member states with OELs for benzene higher than the envisaged scenarios 

MSs where current limits are higher or 
not identified 

% of MSs above 
reference OELV 

Notes 

100%,  DE: Workplace exposure 

concentration corresponding 
to the proposed preliminary 
acceptable cancer risk 
4:100,000: 0.02 ppm 

96% 

82% 

0% 

OEL (ppm) 

0.05 ppm 

0.2 ppm 

0.5 ppm 

AT, BE, BG, CY, CZ, DE, DK, EE, EL, ES, 
FI, FR, HR, HU, IE, IT, LV, LT, LU, MT, NL, 
PL, PT, RO, SE, SI, SK, UK 

AT, BE, BG, CY, CZ, DE, DK, EE, EL, ES, 
FI, FR, HR, HU, IE, IT, LV, LT, LU, MT, PL, 
PT, RO, SE, SI, SK, UK 

AT, BE, BG, CY, CZ, EL, ES, FI, FR, HR, 
HU, IE, IT, LV, LT, LU, MT, PL, PT, RO, SI, 
SK, UK 

 Baseline (1 ppm) 

0 

109 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annex 6: Relevant sectors, uses and activities 

1.  ACRYLONITRILE 

1.1.  Relevant sectors, uses and operations 

1.1.1.  Manufacture of acrylonitrile 

Acrylonitrile is manufactured within a closed process via catalytic ammoxidation of ammonia and 
propylene. This is usually achieved via the Sohio process108.  

During the Sohio process, ammonia and air are passed through a fluidized bed reactor containing 
a  catalyst  (bismuth  phosphomolybdate).  The  reactants  are  then  cooled  in  aqueous  sulfuric  acid 
and  the  excess  propylene,  carbon  monoxide,  carbon  dioxide  and  nitrogen  are  either  vented  or 
incinerated.  The  resulting  solution  consists  of  acrylonitrile,  acetonitrile,  hydrocyanic  acid  and 
ammonium  sulfate  produced  from  excess  ammonia.  A  recovery  column  removes  water  and 
acrylonitrile and acetonitrile are separated via distillation (IGTPAN website, 2018). 

Acrylonitrile is produced within a closed system with very limited exposure expected109 110 111. 

1.1.2.  Overview of downstream users 

Acrylonitrile downstream uses identified can be summarised as follows: 

Main uses 

  Acrylic and modacrylic textile fibres 
  SAN and ABS plastics 
  Manufacture of acrylamide and adiponitrile 
  Nitrile rubbers 
  Carbon fibre 

Other uses 

  Reagent in a laboratory 
  Extraction agents 
  Photo-chemicals 
  Polyether  and  polymeric  polyols  (for  the  manufacturing  of  polyurethane  flexible  foam 

used to produce mattresses and furniture) 
  Carboxylic exchange resins (water treatment);  
  Synthesis  of  amines  (Examples  include:  i)  Pesticides,  ii)  Disinfectants,  iii)  Housekeeping: 

Laundry detergent, fabric softener, etc. iv) Personal care: e.g. shower gel); 

108 SCOEL (2003): Recommendation from the Scientific Committee on Occupational Exposure Limits for Acrylonitrile,. Available at: 
http://ec.europa.eu/social/BlobServlet?docId=6699&langId=en 
109  ECHA  [European  Chemicals  Agency]  (2018):  Opinion  on  scientific  evaluation  of  occupational  exposure  limits  for  Acrylonitrile. 
ECHA/RAC/ O-0000001412-86-188/F.  
Available  at  https://echa.europa.eu/documents/10162/13641/acrylonitrile_opinion_en.pdf/102477c9-a961-2c96-5c4d-76fcd856ac19  on 
15 January 2019. 
110  ECB  [European  Chemicals  Bureau]  (2004):  European  Union  Risk  Assessment  Report  for  Acrylonitrile.    Report  by  Institute  for 
Health and Consumer Protection for the European Chemicals Bureau.  
Available at https://echa.europa.eu/documents/10162/22bf49d3-e951-44b8-a45a-6973d3dc62f6 on 11 December 2018.  
111 EFTEC, Economics for the Environment, Socio-Economic Analysis: Occupational Exposure Limits for Acrylonitrile, For European 
Chemical Industry Council (cefic) -Acrylonitrile Sector Group, December 2018 (unpublished) 

110 

 
 
                                                           
 
  Coatings, construction chemicals and adhesives used to glue plastics and rubbers.  

According to the RAC’s background document on acrylonitrile, 750,000 tonnes of acrylonitrile is 
manufactured  per  year  within  the  EU.  Similarly,  according  the  Acrylonitrile  Sector  Group 
approximately  720,000  tonnes  of  acrylonitrile  are  produced  in  the  EU  each  year,  with 
approximately 129,000 tpa exported to non-EU countries, and 95,000 tpa imported into the EU – 
resulting  in  approximately  686,000  tonnes  of  acrylonitrile  being  used  in  the  EU  each  year.  The 
following  table  provides  a  breakdown  of  those  tonnages  by  use,  according  to  the  tonnages 
estimated by RAC and the Acrylonitrile Sector Group. 

Table 51 - Tonnage of acrylonitrile used per year according to RAC and the Acrylonitrile Sector 
Group 

Use 

Tonnage of acrylonitrile used per year (RAC 
Background document) 

Tonnage of acrylonitrile used per year 
(Acrylonitrile Sector Group) 

Acrylic and 
modacrylic textile 
fibres 

315,000 (42%) 

200,000 (29%) 

ABS and SAN 
plastic resins 

179,300 (24%) 

Nitrile rubber 

53,000 (7%) 

Acrylamide 

136,000 (18%) 

Carbon fibre 

Not mentioned 

Other  

66,700 (9%) 

(Source: COWI (2019)) 

184,000 (27%) 

45,000 (7%) 

147,000 (21%) 

11,000 (2%) 

99,000 (14%) 

The following table provides an overview of the processes during which acrylonitrile is used.  

Table 52 - Processes during which use of acrylonitrile occurs (from ECHA, 2018) 

Use 

Process(es) during which use occurs 

Manufacture of acrylonitrile 

Acrylonitrile is manufactured via the Sohio process which is carried out within a 
closed system. 

Production of acrylic and 
modacrylic textile fibres 

The manufacturing process for acrylic fibres comprises four mains steps:  
i) receiving the monomer into bulk storage,  
ii) polymerisation  
iii) spinning, and  
iv) finishing including drying and baling  

Local exhaust ventilation (LEV) and personal protection equipment (PPE) are used 
when not part of a closed system (for spinning and finishing activities) 

Production is carried out in a partially closed system, with local exhaust ventilation. 
Both LEV and PPE are used. 

Production of acrylonitrile-
butadiene-styrene (ABS) and 
styrene-acrylonitrile (SAN) 
plastics 

Monomer for production of 
nitrile rubbers 

Acrylonitrile is used as a feedstock in the production of nitrile rubbers. This process 
is predominantly carried out within a closed system. Both LEV and PPE are used 

111 

 
 
 
when not part of a closed system. 

Intermediate for the production 
of bulk chemicals, resins and 
adiponitrile/acrylamide 
synthesis 

Acrylonitrile is used as in intermediate to produce acrylamide. Acrylamide is formed 
via the hydration of acrylonitrile. 

Adiponitrile is no longer produced in the EU (according to information received 
from the Acrylonitrile Sector Group via email correspondence) 

Laboratory reagent 

LEV and PPE are used. 

(Source: COWI (2019)) 

The following table provides an overview of acrylonitrile-based products. 

Table 53 -  Key acrylonitrile-based products and their uses 

Acrylonitrile-based 
products 

Evaluated uses of products 

Acrylic and modacrylic 
textile fibres 

These textile fibres absorb little water and are quick drying, although not particularly 
strong. They can be found in clothing, fake fur, awnings and blankets, among others 

Styrene-acrylonitrile resin 
(SAN) 

SAN is a hard transparent and easily processed material. It is used for 
kitchen equipment such as mixing bowls, fittings for refrigerators, jugs, 
tableware, and coffee filters 

Acrylonitrile-
butadienestyrene 
(ABS) resin 

Nitrile rubbers 

(Source: COWI (2019)) 

ABS is a material consisting of a two-phase polymer blend. It has a wide 
range of applications including domestic appliances, telephone handsets, 
lawnmower covers, safety helmets, luggage shells, pipes and fittings 

Nitrile rubber is oil resistant and its main applications are therefore as seals and 
connectors for the oil and gas industry. Nitrile rubber is also used for similar reasons by 
the automotive industry 

The sector of use as from the ECHA registrations for acrylonitrile are listed in the following table.   

Table 54 -  Sectors of use for acrylonitrile listed in the ECHA registrations 

Registration 

Sector of end use (SU) 

Acrylonitrile – Full 
registration 1 000 000 - 10 
000 000 tonnes per 
annum 

SU 0: Other: SU 22: Professional uses 

SU3: Industrial manufacturing 

SU 5: Manufacture of textiles, leather, fur 

SU 8: Manufacture of bulk, large scale chemicals (including petroleum 
products) 

SU 9: Manufacture of fine chemicals 

SU 10: Formulation [mixing] of preparations and/or re-packaging 
(excluding alloys) 

SU 11: Manufacture of rubber products 

112 

 
 
SU 12: Manufacture of plastics products, including compounding and 
conversion 

SU 16: Manufacture of computer, electronic and optical products, electrical 
equipment 

SU 19: Building and construction work 

SU 20: Health services 

SU 22: Professional use 

SU 24: Scientific research and development 

(Source: COWI (2019)) 

1.2.  Exposed workforce 

It is important to obtain the number of employees potentially exposed to acrylonitrile in order to 
calculate  the  potential  benefits  of  implementing  any  new  measures.    The  following  datasets 
concerning number of workers exposed to acrylonitrile were identified: 

  Carex EU 
  Carex Canada 
 

INRS  (The  French  National  Research  and  Safety  Institute  for  the  Prevention  of 
Occupational Accidents and Diseases) 

  ASA (ASA register (of occupational exposure hazards and procedures in Finland) 
  Acrylonitrile Sector Group 

The following table summarises the numbers of workers exposed to acrylonitrile according to the 
different sources of data identified. In some cases the data is not comparable (the sectors do not 
match or  overlapped with  other  sectors).  The  sectors  have  been  compared  where  possible  and 
the  final  total  has  been  included  for  each  of  the  datasets.  Carex  Canada,  INRS  and  ASA  figures 
include  both  the  original  and  extrapolated  EU  figures;  the  extrapolated  figures  have  been 
adjusted based on population. 

Table 55 -  Summary of number of workers exposed according to the data sources identified 

Sector 

Carex EU 

Carex Canada 

INRS 

ASA 

Acrylonitrile 
Sector Group 
(CEFIC) 

Production 

Not provided 

Not provided 

Not provided 

Not provided 

500 

Acrylic fibre 

660 

SAN and 
ABS resins 

8,093 

Original: 100 
EU: 1,396 

Original: 4,000 
EU: 55,854 

Not comparable 

Not provided 

3,750 

Not comparable 

Original:20 
EU: 1,863 

1,250 

113 

 
 
 
 
Nitrile 
Rubber 

8,527 

Original: 700 
EU: 9,774 

Original:150–500 
EU:1,146–3,819 

Not provided 

1,750 

Acrylamide 

7,431 

Not provided 

Original: 1,500–5,000 
EU: 

Not comparable 

1,000 

Carbon 
fibre 

Not provided 

Not provided 

Not provided 

Not provided 

250 

Other 

7,076 

Total 

31,787 

(Source: Cowi (2019)) 

Original:1,100 
EU: 15,360 

Original: 5,900 
EU: 82,385 

Not comparable 

Not comparable 

1,750 

Original: 5,200–
106,919 
EU : 40,095–107,683 

Original: 184 
EU: 17,139 

10,250 

Due  to  the  acrylonitrile  industry  appearing  concentrated  in  a  relatively  small  number  of  large 
companies,  it  is  likely  that  there  will  be  significant  differences  between  the  Member  States  in 
terms of numbers  of workers  exposed.  The data sources  that have  been compiled at EU levels 
have  therefore  been  selected,  providing  an  upper  and  a  lower  estimate  for  the  exposed 
workforce. 

1.2.1.  The low and high estimates taken for exposed workforce 

Based on the Carex EU and the Acrylonitrile Sector Group data, the number of exposed workers is 
estimated to be approximately 10,000–33,000 workers. 

The  Carex EU  data  are  relatively old  (1999)  and  have  therefore  been  converted  to  2016  figures 
based on population data  taken from Eurostat.  The Carex  EU data are  considered to provide  a 
higher estimate as they are based on figures of potentially exposed workers (which includes some 
workers unlikely to be exposed). 

The following table summarises the numbers of workers exposed to acrylonitrile for each sector 
according to these two sources of data. 

Table 56 -   Summary number of exposed workers per sector according to the Acrylonitrile 
Sector Group and Carex EU data 

114 

 
 
 
 
 
 
 
 
 
Sector 

Acrylonitrile Sector Group (CEFIC) 

Carex EU (converted to 2016) 

Production 

Acrylic fibre 

SAN and ABS resins 

Nitrile Rubber 

Acrylamide 

Carbon fibre 

Other 

Total 

500 

3,750 

1,250 

1,750 

1,000 

250 

1,750 

10,250 

Not provided 

692 

8,487 

8,942 

7,793 

Not provided 

7,421 

33,335 

The data taken from the Acrylonitrile Sector Group’s SEA are the lower of two sets of estimates 
provided within the SEA itself, and are based on the direct number of persons employed within 
the industry. An indirect number has also been provided in the SEA, but the direct numbers have 
been chosen so as to represent the lowest possible estimate. The direct numbers include those 
employed  by  the  two  manufacturers  of  acrylonitrile  plus  those  employed  by  the  initial 
downstream users of acrylonitrile.  

During consultation it was also indicated that acrylonitrile storage facilities are located within the 
EU. It has been estimated, based on the data provided in consultation, and via literature reviews, 
that  approximately  10  storage  sites  could  be  present  within  the  EU.  The  numbers  of  workers 
exposed  within  this  sector  are  not  expected  to  be  high,  and  so  the  estimates  provided  by  the 
Acrylonitrile  Sector  Group  and  Carex  EU  will  remain  the  same  once  rounded  (10,000–33,000). 
‘Storage’  has  been  added  as  a  sector  for  the  analysis  of  the  costs  and  benefits  (see  Market 
Analysis). 

1.2.2.  Trends 

Demand in acrylic fibres has decreased due to competition from the cheaper polyester fibres. This 
is  likely  to  have  resulted  in  a  decline  in  the  number  of  workers  exposed  to  acrylonitrile  in  this 
sector since 2000112.  

The  numbers  of  those  working  within  the  ABS  plastics  industry  are  however  expected  to  have 
increased due to growing demand for these lightweight materials within new technology such as 
automobiles and 3D printing applications113. 

The  nitrile  rubber  market  has  also  experienced  some  growth  due  to  increased  production  of 
nitrile gloves114. 

IHS  Markit 

112 
https://ihsmarkit.com/products/acrylonitrile-chemical-economics-handbook.html  

–  Chemical 

‘Acrylonitrile 

(2017): 

Economics  Handbook’, 

accessed 

on 

16/01/19 

at: 

113 Mordor Intelligence (2018): ‘Global Acrylonitrile Market – Segmented by End-user Industry and Geography – Growth, Trends and 
Forecast  (2019–2024),  accessed  on  16/01/19  at:  https://www.mordorintelligence.com/industry-reports/global-acrylonitrile-acn-market-
industry  

115 

 
 
                                                           
The  exact  rate  at  which  the  workforce  has  grown  is  not  known,  however  based  on  the  above 
qualitative data it is assumed that size of the workforce is likely to be constant. 

1.2.3.  Exposed workers: conclusion 

The  data  collected  through  consultation  for  this  study  provides  evidence  of  around  10,250  to 
33,335 workers currently exposed to acrylonitrile.  It is important to note that the upper estimate 
is  likely  to  include  some  workers  that  would  not  be  directly  exposed  to  acrylonitrile,  while  the 
lower  estimate  only  takes  into  account  the  direct  number  of  workers  exposed  (i.e.  those 
employed by the 2 manufacturers of acrylonitrile and the initial downstream users).  

Estimate 

Highest estimate 

Lowest estimate 

Table 57 - Exposed workforce: conclusion 

No of exposed workers 

33,335 

10,250 

Estimate taken forward for modelling 

10,000-33,000 

Alternative estimate for the sensitivity analysis 

Taken into account in the range above 

Annual rate of change taken forward for modelling 

0% (past and future) 

2.  NICKEL COMPOUNDS  

2.1.  Relevant sectors, uses and operations 

2.1.1.  Overview of uses and manufacturing processes 

A wide variety of nickel compounds occur in intermediate use, such as115:  

  Nickel chloride and nickel hydroxide are used catalysts in the metallurgic industry. 
  Nickel acetate and nickel sulphate are used to manufacture catalysts and other nickel 

compounds.  

  Trinickel disulphide is used as an intermediate in the primary nickel industry.  

The manufacturing processes (PROCs) relating to nickel compounds under the CMD in REACH 
registration dossiers is shown in table 58 below.  

114 See footnote 18 
115  IARC (2012), Nickel and nickel compounds (updated 26 July 2017)  IARC monographs on the evaluation of carcinogenic risks of 
chemicals to humans, vol. 100C. Available at: https://monographs.iarc.fr/wp-content/uploads/2018/06/mono100C-10.pdf. 

116 

 
 
                                                                                                                                                                                
Table 58 – Nickel compounds and their PROCs according to REACH dossiers116 

Process  

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PROC 1: Chemical production or refinery in closed process without likelihood 
of exposure or processes with equivalent containment conditions 

                   

PROC 2: Chemical production or refinery in closed continuous process with 
occasional controlled exposure or processes with equivalent containment 
conditions 

                   

PROC 3: Manufacture or formulation in the chemical industry in closed batch 
processes with occasional controlled exposure or processes with equivalent 
containment condition 

                   

PROC 4: Chemical production where opportunity for exposure arises 

                   

PROC 5: Mixing or blending in batch processes 

 

           

     

PROC 8a: Transfer of substance or mixture (charging and discharging) at 
non-dedicated facilities 

                   

PROC 8b: Transfer of substance or mixture (charging and discharging) at 
dedicated facilities 

                   

PROC 9: Transfer of substance or mixture into small containers (dedicated 
filling line, including weighing) 

                   

PROC 10: Roller application or brushing 

           

     

PROC 11: Non-industrial spraying 

   

PROC 13: Treatment of articles by dipping and pouring 

 

           

     

PROC 14: Tabletting, compression, extrusion, pelletisation, granulation 

       

       

PROC 15: Use as laboratory reagent 

         

         

PROC 19: Hand-mixing with intimate contact and only PPE available 

 

PROC 21: Low energy manipulation of substances bound in materials and/or 
articles 

 

   

     

PROC 22: Potentially closed processing operations with minerals/metals at 
elevated temperature. Industrial setting 

               

116  ECHA  (2018),  “Background  document  in  support  of  the  Committee  for  Risk  Assessment  (RAC)  for  evaluation  of  limit  values  for 
at: 
ECHA/RAC/O-0000001412-86-189/F. 
nickel 
https://echa.europa.eu/documents/10162/13641/nickel_bg_annex1_en.pdf/12d24cbf-8f7e-0f1f-64c3-4992df4d00e8 

workplace”. 

compounds 

Available 

and 

the 

its 

in 

117 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
Process  

l

PROC 23: Open processing and transfer operations with minerals/metals at 
elevated temperature 

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PROC 24: High (mechanical) energy work-up of substances bound in 
materials and/or articles 

 

     

   

PROC 25: Other hot work operations with metals 

 

   

PROC 26: Handling of solid inorganic substances at ambient temperature 

             

     

PROC 27a: Production of metal powders (hot processes) 

 

PROC 28: Manual maintenance (cleaning and repair) of machinery 

                   

2.1.2.  Overview of sectors 

The COWI study identified the following industrial sectors as using nickel compounds under the 
CMD and having employees at risk of exposure to nickel compounds. 

118 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 

NAC
E 

Type of data (3) 

Year 

Table 59 – Sectors using nickel compounds under the CMD 

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5
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201
9 

201
8 

201
8 

201
9 

201
8 

200
8 

1990 -1993 & 
1997 

201
4 

198
1-
198
3 

199
0-
199
3 

Y 

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200
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200
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201
4 

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200
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Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

A 

Agriculture, biogas production 

Y 

Y 

A7 

Mining of metal ores 

C10 

Manufacture of food products 

C13.
99 

C19.
2 

C20.
12 

C20.
13 

C20.
30 

Manufacture of other textiles n.e.c. 

Manufacture of refined petroleum products (using catalysts) 

Manufacture of dyes and pigments 

Manufacture of other inorganic basic chemicals 

Manufacture of paints, varnishes and similar coatings, 
printing ink and mastics 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

119 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 

NAC
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Type of data (3) 

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0 

200
8 

201
7 

200
0 

201
4 

201
8 

201
8 

Manufacture of other chemical products n.e.c. (inc catalysts) 

Y 

Y 

Y 

Y 

Year 

C20.
59 

C21.
1 

Manufacture of basic pharmaceutical products 

C22 

Manufacture of rubber and plastic products 

C23 

Manufacture of other non-metallic mineral products 

Production of abrasive products 

C23.
91 

C24 

Manufacture of basic metals 

Manufacture of basic iron and steel and of ferro-alloys  

Precious metals production 

Lead, zinc and tin production 

C24.
1 

C24.
41 

C24.
43 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

120 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 

NAC
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Type of data (3) 

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1990 -1993 & 
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201
4 

198
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201
8 

200
3 & 
201
0 

201
0 

200
8 

201
7 

200
0 

201
4 

201
8 

201
8 

Other non-ferrous metal production 

Y 

Manufacture of fabricated metal products, except machinery 
and equipment 

Manufacture of other tanks, reservoirs and containers of 
metal  

Manufacture of weapons and ammunition 

Forging, pressing, stamping and roll-forming of metal; 
powder metallurgy 

Treatment and coating of metals 

Manufacture of tools 

Y 

Y 

Manufacture of other fabricated metal products n.e.c 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Year 

C24.
45 

C25 

C25.
29 

C25.
4 

C25.
5 

C25.
61 

C25.
73 

C25.
99 

C26 

Manufacture of computer, electronic and optical products 

Y 

Y 

Y 

Y 

121 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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S
R
N

I

E 

R
E
M
U
S

n
o
s
h
g
u
H

a
i
z
d
n
e
K

M
O

I

A
A
G
B

V
U
G
D

i
l
l

e
s
r
a
c
S

i
l
l

e
s
r
a
c
S

W 

E 

E 

E 

E 

E 

E 

W 

201
9 

201
8 

201
8 

201
9 

201
8 

198
1-
198
3 

199
0-
199
3 

200
8 

1990 -1993 & 
1997 

201
4 

198
7 - 
201
8 

200
3 & 
201
0 

201
0 

200
8 

201
7 

200
0 

201
4 

201
8 

201
8 

C27 

Manufacture of electrical equipment 

Manufacture of batteries and accumulators 

C27.
2 

C28 

Manufacture of machinery and equipment n.e.c. 

Y 

Y 

Y 

Y 

Y 

Y 

C29 

Manufacture of motor vehicles, trailers and semi-trailers 

C30 

Manufacture of other transport equipment 

C31 

Manufacture of furniture 

C32 

Other manufacturing 

C33 

Repair and installation of machinery and equipment 

C37 

Sewerage 

Materials recovery 

E38.
3 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

122 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 

NAC
E 

Type of data (3) 

Year 

)
5
(

n
o
i
t
a
t
l
u
s
n
o
C

W, 
E 

s
R
S
C

E 

I

H
S
O
N
2
1
0
2
C
R
A

I

X
E
R
A
C
2
1
0
2
C
R
A

I

)
1
(
A
S
U

)
2
(

U
E

R
A
R
U
E

U
E
X
E
R
A
C

r
o
t
c
e
s

I

N

U
S
H
C
A
E
R

C
A
R

M 

M 

W 

W 

M 

W 

)
4
(
A
S
A

W 

S
R
N

I

E 

R
E
M
U
S

n
o
s
h
g
u
H

a
i
z
d
n
e
K

M
O

I

A
A
G
B

V
U
G
D

i
l
l

e
s
r
a
c
S

i
l
l

e
s
r
a
c
S

W 

E 

E 

E 

E 

E 

E 

W 

201
9 

201
8 

201
8 

201
9 

201
8 

198
1-
198
3 

199
0-
199
3 

200
8 

1990 -1993 & 
1997 

201
4 

198
7 - 
201
8 

200
3 & 
201
0 

201
0 

200
8 

201
7 

200
0 

201
4 

201
8 

201
8 

F 

Construction 

M71 

Architectural and engineering activities; technical testing and 
analysis 

M72 

Scientific research and development  

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Y 

Welding 

Plus 

A, 

(6) 

(7) 

P85 

(8) 

Y 
(5) 

Y 

Y 

Sources: RAC (2018a), EU RAR (2008), CAREX (undated), ASA (2014, IARC (2012), IARC (2018), SUMER (2010), IOM (2008), Hughson (2009), Kendzia (2017), BGAA (2000), Scarselli (2018), CSRs 
(confidential) and consultation responses (confidential) 
Notes 1 60% of exposed workers in sectors below 

5 Plus several more papers listed in Table 1.9 of IARC (2018) 

2 83% of exposed workers in sectors below 

3 W = workers, E = exposure, M = mention 

4 Sectors with over 100 workers exposed 

6 Slags, ferronickel manufacturing (RAC, 2018a) 

7 NACE codes: B6, C11, C13, C14, C15, C16, C17, C18, D35, H49, I, Q, M75, S96 

8 Several sectors see Appendix Error! Reference source not found. 

123 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The table below  shows the  percentage of enterprises in key sector that  are small, medium or 
large  sized  enterprises.  It  is  based  upon  the  proportions  for  small,  medium  and  large  from 
Eurostat data for enterprises at the NACE code. 

Table 60 - Distribution of EU enterprises with exposed workers by size of enterprise by sector 

NACE 

Sector 

Number of enterprises 

Sector 

Small      <50        

Medium    50-

Large    >249      

Total 

employees 

249   
employees 

employees 

C19.2 Oil refineries 

C20.12 Pigments 

C20.30 Frits 

C20.59 Catalysts 

C23 Glass 

C24 Metals 

C25.61 Metal surface treatment  

C25.61 Beyond 

C27.2 Batteries  

E38.3 Materials recovery 

Welding 

Total 

Source: Eurostat (2016), consultation 

2.1.3.  Overview of sectors 

856 

0 

0 

28 

1,069 

100 

27,694 

27,694 

0 

1,925 

51 

76 

2 

10 

56 

50 

123 

759 

759 

6 

55 

100 

59,417 

1,996 

87 

9 

40 

56 

17 

147 

84 

84 

4 

20 

100 

648 

1,019 

11 

50 

140 

1,136 

370 

28,536 

28,536 

10 

2,000 

251 

62,059 

Table 61 - Nickel compounds under the CMD – summary of past exposure (inhalable) 
concentrations for analysis (1990 – present day) 

Sector 

Exposure at percentile (mg/m3) 

C19.2 Oil refineries 

C20.12 Pigments 

C20.30 Frits 

50 

75 

90 

95 

100 

0.03 

0.03 

0.07 

0.09 

0.1 

0.024 

0.03 

0.043 

0.046 

0.05 

0.014 

0.03 

0.053 

0.06 

0.067 

124 

 
 
Sector 

Exposure at percentile (mg/m3) 

50 

75 

90 

95 

100 

C20.59 Catalysts 

0.011 

0.03 

0.045 

0.05 

0.343 

C25.61 Metal surface treatment  

0.098 

0.23 

C23 Glass 

C24 Metals 

C25.61 Beyond 

C27.2 Batteries  

0.01 

0.04 

0.19 

0.45 

0.696 

0.04 

0.08 

0.098 

0.23 

0.2 

0.8 

0.8 

0.61 

2.78 

1.1 

1.384 

1.1 

1.384 

0.03 

0.13 

0.37 

0.57 

0.76 

E38.3 Materials recovery 

0.014 

0.01 

0.05 

0.12 

0.186 

Welding 

0.02 

0.0386 

0.25 

0.42 

0.65 

Table 62 - Nickel compounds under the CMD – summary of current exposure concentrations 
(inhalable) for analysis 2010 to present day 

NACE 

Sector 

Exposure at percentile (mg/m3) 

50 

75 

90 

95 

C19.2 Oil refineries 

0.03 

0.03 

0.07 

0.09 

100 

0.1 

C20.12 Pigments 

C20.30 Frits 

C20.59 Catalysts 

C23 Glass 

C24 Metals 

0.024 

0.03 

0.043 

0.046 

0.05 

0.014 

0.03 

0.053 

0.06 

0.067 

0.011 

0.03 

0.045 

0.05 

0.343 

0.004 

0.03 

0.043 

0.046 

0.05 

0.033 

0.04 

0.144 

0.175 

0.27 

C25.61 Metal surface treatment  

0.03 

0.04 

0.149 

0.181 

0.25 

C25.61 Beyond 

C27.2 Batteries  

0.03 

0.04 

0.149 

0.181 

0.25 

0.012 

0.03 

0.045 

0.05 

0.2 

E38.3 Materials recovery 

0.0003 

0.002 

0.0028 

0.003 

0.0032 

Welding 

0.004 

0.02 

0.05 

0.084 

0.116 

125 

 
 
 
2.2.  Exposed workforce 

COWI study evalutates the number of exposed workers to nickel compounds under the scope of 
the  CMD,  by  taking  into  account  several  sources  of  information.  Further  information  can  be 
found in this study117.  

The  study  consultation  response  gave  some  detailed  responses  about  the  number  of  workers 
exposed on a given site and the total number of workers at a site. Only sectors where at least 
three  respondents  provided  the  data  are  included.    Overall,  the  average  number  of  exposed 
workers in a company using nickel compounds is 9.6%.  Generally, if no other data is available, 
the study team assumes that  10% of workers  in an enterprise using nickel compounds will be 
exposed to them. 

 Table 63 – Percentage of exposed workers in company using nickel compounds under the 
scope of the CMD, from the consultation survey 

NACE 

Sector 

C20.30 

Manufacture of paints and coatings (frits) 

C20.59 

Manufacture of other chemical products (catalysts) 

C24 

Manufacture of basic metals and alloys 

C25 

Treatment and coating of metals 

C27.2 

Manufacture of batteries and accumulators 

% of exposed 
workers 

13% 

3% 

32% 

7% 

22% 

Based on all this information, the study team’s estimates are the following:  

Table 64 – Summary of extrapolation of EU workers exposed to nickel compounds under the 
CMD in key sectors 

Sector 

NAC
E 

Total number of workers in this NACE code 
(2016) 

C19.2 Oil refineries 

C20.12 Pigments 

C20.30 Frits 

117 See footnote 18 

122,962 

30,146 

150,157 

126 

Study 
team 
estimat
e of 
expose
d 
worker
s 

6,148 

230 

500 

% of all workers in NACE 
code 

5% 

0.8% 

0.3% 

 
 
                                                           
Sector 

NAC
E 

Total number of workers in this NACE code 
(2016) 

C20.59 Catalysts 

C23 Glass 

C24 Metals 

C25.61 Metal surface 
treatment  

C25.61 Beyond 

C27.2 Batteries  

Welding 

E38.3 Materials recovery 

Total 

131,047 

247,487 

400,825 

1,269,547 

NA 

26,328 

NA 

174,068 

2,552,567 

Study 
team 
estimat
e of 
expose
d 
worker
s 

4,000 

2,361 

5,840 

31,099 

31,099 

500 

3,100 

2,611 

87,488 

% of all workers in NACE 
code 

3% 

1% 

1.3% 

2.4% 

NA 

2% 

NA 

1% 

NA 

2.2.1.  Comparison of workers exposed from different sources 

In table 65, the estimates from the four sources are compared for all sectors and welding is also 
included.  Data is also available from the SUMER database118 but cannot easily be allocated to 
the sectors.  The total estimated number of exposed workers is 713,201.  A further estimate is 
available  from  the  CAREX  estimates  in  Spain  done  in  2004119  and  this  estimates  that  90,964 
workers  are  exposed  to  nickel  metal  and  nickel  compounds  in  Spain,  which  extrapolates  to 
909,927  workers  across  the  EU.    Estimates  from  ASA,  CAREX  and  SUMER  include  workers 
exposed to nickel metal as well as nickel compounds. 

The study team’s estimates are used for the remainder of the analysis because  the estimates 
based upon the ASA and CAREX data includes many workers exposed to nickel metal; this study 
is  specifically  only  concerned  about  workers  exposed  to  nickel  compounds.    These  numbers 
would  be  a  significant  overestimate of  the  number of  workers  exposed  to  nickel  compounds.  
The  estimates  based  upon  Scarselli  data  are  believed  to  be  underestimates  as  not  all  Italian 
companies using carcinogenic materials are registered on SIREP.   

118 SUMER (2010): Les expositions aux risques professionnels. Les produits chimiques. SUMER. 
119  CAREX  (2004):  Information  System  about  Occupational  Exposure 
http://istas.net/descargas/InformeCarex.pdf. 

to  Carcinogens 

in  Spain 

in 

the  year  2004 

127 

 
 
 
                                                           
 
Table 65 – Summary of estimated number of EU workers exposed to nickel compounds under 
the CMD in key sectors 

NACE 

Sector 

ASA 2014120 

CAREX 1999121 

Scarselli 2018122 

Study team 
estimates 
Eurostat, survey 
and industry 
data, 2019 

Exposure to nickel metal and 
compounds 

Exposure to nickel compounds only 

C19.2  Oil refineries 

462 

400 

C20 

C23 

Manufacture of chemicals 
and chemical products 

Manufacture of other non-
metallic mineral products 

28,082 

13,072 

6,858 

5,279 

C24 

Manufacture of basic metals 

75,485 

58,672 

3,227 

2,326 

864 

470 

6,148 

4,730 

2,361 

5,840 

C25 

Manufacture of fabricated 
metal products, except 
machinery 

137,270 

195,597 

13,761 

31,099 

Beyo

C10, C21, C22, C16, C27, C28, 

213,584 

219,428 

11,351 

31,099 

C29, C30, C31, C31, F43, M72 

nd 
C25 

C27.2  Manufacture of batteries and 

- 

- 

500 

accumulators 

E38.3  Materials recovery 

NA 

Welding 

21,106 

NA 

- 

NA 

1,216 

NA 

2,611 

3,100 

TOTAL 

482,847 

492,448 

33,215 

87,488 

2.2.2.  Exposed workers of reproductive age  

One  of  the  non-cancer  outcomes  is  reprotoxic  effects  and  these  apply  to  both  women  of 
reproductive  age  (15  –  50  years)  and  to  the  partners  of  men  of  reproductive  age  (all  ages).  
Therefore,  the  numbers  of  exposed  workers  need  to  be  multiplied  by  this  percentage  before 

120  ASA  (2014),  ASA  2014  Syöpäsairauden  vaaraa  aiheuttaville  aineille  ja  menetelmille  ammatissaan  altistuneiksi  ilmoitetut 
Suomessa. TYÖTERVEYSLAITOS HELSINKI. Available at: http://www.julkari.fi/handle/10024/131073.   
121  CAREX  (1999):  International  Information  System  on  Occupational  Exposure  to  Carcinogens.  CAREX.  Available  at: 
https://www.ttl.fi/wp-content/uploads/2018/01/EU_5_exposures_by_agent_and_industry.pdf 
122  Scarselli,  Alberto,  Di  Mazio,  Davide,  Marinaccio,  Alessandro,  Lavicoli,  Sergio  (2018):  Nickel  compounds  in  the  workplaces: 
Occupations  and  activities  involving  high-risk  exposures  in  Italy.  Am  J  Ind  Med,  61  (12),  pp  968-977.  Available  at 
https://www.ncbi.nlm.nih.gov/pubmed/30352130 

128 

 
 
 
                                                           
calculating  the  cases  of  reprotoxic  outcomes.  The  average  percentage  of  workers  of 
reproductive age for the key sectors is shown in table 66. 

Table 66 – Percentage of exposed workers of reproductive age 

NACE 

Sector 

% of reproductive age (1) 

C19.2 

Manufacture of refined petroleum products 

C20.12 

Manufacture of dyes and pigments 

C20.30 

Manufacture of paints and coatings 

C20.59 

Manufacture of other chemical products 

C23 

C24 

C25 

Manufacture of other non-metallic mineral products 

Manufacture of basic metals 

Treatment and coating of metals 

C27.2 

Manufacture of batteries and accumulators 

E38.3 

Materials recovery 

NA 

Welding123 

2.2.3.  Exposed workers: conclusion  

94% 

92% 

92% 

92% 

93% 

96% 

95% 

92% 

95% 

95% 

Table 67 – Estimated number of EU workers exposed to nickel compounds under the CMD in 
key sectors 

The  data  collected  through  consultation  for  this  study  provides  evidence  of  approximately 
87,488 workers currently exposed to nickel compounds under the CMD.   

Sector 

C19.2 Oil refineries 

C20.12 Pigments 

C20.30 Frits 

C20.59 Catalysts 

C23 Glass 

C24 Metals 

C25.61 Metal surface treatment  

C25.61 Beyond 

123 Welding is an average of the other sectors.  

129 

Estimated exposed workers 

6,148 

230 

500 

4,000 

2,361 

5,840 

31,099 

31,099 

 
 
 
 
 
 
 
 
 
 
 
                                                           
Sector 

C27.2 Batteries  

E38.3 Materials recovery 

Welding 

Total 

3. 

BENZENE 

Estimated exposed workers 

500 

2,611 

3,100 

87,488 

3.1.  Relevant sectors, uses and operations 

3.1.1.  Manufacture of benzene 

Benzene is produced in petroleum refinery and chemical plant processes, primarily by catalytic 
reforming, steam cracking and dealkylation. Benzene can also be recovered during production 
of  coal-derived  chemicals,  primarily  from  coke  oven  by-products.  It  is  extracted  from  these 
sources  and  purified  for  industrial  use.  Benzene  is  manufactured  and/or  imported  in  the 
European  Economic  Area  in  a  quantity  of  1,000,000  to  10,000,000  tonnes  per  year.  Under 
REACH,  the  registered  substance  reporting  “benzene”  as  its  substance  identity  has  been 
registered  mainly  as  transported  isolated  intermediate  or  onsite  isolated  intermediate124. 
Petrochemicals  Europe  state  that  the  European  production  of  benzene  is  about  8  million 
tons/year125 

The  typical  feedstocks  to  catalytic  reformer  units  are  the  hydrotreated  straight-run  heavy 
naphtha  from  crude  oil  distillation  units  and,  if  applicable,  the  hydrotreated  heavy  naphtha 
stream from hydrocracker units or coking units, as well as medium catalytically cracked naphtha 
stream from a FCC (fluid catalytic cracking) unit. Products from a reformer include, in addition 
to  the  hydrogen:  refinery  fuel  gas,  LPG,  isobutene;  n-butane  and  reformate.  The  reformate 
contains benzene and may be blended into petrol126 or further separated into its components as 
chemical feedstocks (benzene, toluene, xylene, and naphtha cracker feeds)127.  

In  the  lower  olefins  sector128,  steam  cracking  processes  produce  pyrolysis  gasoline,  which 
contains benzene and other aromatics. Pyrolysis gasoline (also called pygas) constitutes about 
60% of the feedstock for aromatics plants, which produce benzene as well as other aromatics by 
extraction with a purity of up to 99.9%. Alternatively, pyrolysis gasoline is blended with other 

124 See footnote 22 
125  European  Market  overview  data  available  from:  https://www.petrochemistry.eu/about-petrochemistry/petrochemicals-facts-and-
figures/european-market-overview/ 
126  Please  note  that  usually  the  British  English  term  'petrol'  is  used,  while  'gasoline'  (Am.  English)  is  only  used  when  required  by 
context. However, 'petrol' and 'gasoline' denote the type of petroleum-derived liquid. 
127  Best  Available  Techniques  (BAT)  Reference  Document  (2015),  BAT  Reference  Document  for  the  Refining of  Mineral  Oil  and 
Gas.  Available  at:  https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/best-available-techniques-bat-
reference-document-refining-mineral-oil-and-gas-industrial. 
128 Olefins (= alkenes), such as ethylene, are produced by steam cracking aliphatic hydrocarbons. 

130 

 
 
 
 
 
 
                                                           
hydrocarbons to produce petrol. The remaining 40% of feedstock for aromatics plants is derived 
from refineries and coal chemistry streams129.  

Benzene is also formed during coking of coal. Benzene and other aromatics are present in the 
coke oven gas and are recovered as by-products from the coking process. 

3.1.2.  Overview of the sectors 

The  RAC  background  document130  summarises  in  table  68  below  work  areas/sectors  where 
occupational  exposures  to  benzene  have  been  measured.  This  table  has  been  supplemented 
with  data  from  further  publications  as  well  as  information  received  during  stakeholder 
consultation.  

The table 68 shows that exposure to benzene occurs and/or has historically occurred in up to 15 
sectors  and  in  many  occupational  settings.  Some  activities,  such  as  tank  maintenance  and 
cleaning,  and  loading/unloading  of  benzene-containing  streams,  are  relevant  for  numerous 
sectors. The study devotes most attention to the sectors where occupational exposure is likely 
to  be  a  significant  issue  based  on  exposure  concentrations,  number  of  workers  exposed  and 
trends in exposure. The table 69 list the relevant NACE-codes for the sector 

Table 68 - Work areas with occupational exposures to benzene 

129 LOA (2018), Detailed comments on the ECHA proposal for benzene workplace OEL values. Embeded in Benzene Annex 2 of the 
RACT  (2018)  opinion  available  at:  https://echa.europa.eu/da/about-us/who-we-are/committee-for-risk-assessment/opinions-of-the-
rac-adopted-under-specific-echa-s-executive-director-requests 
130 See footnote 22 

131 

 
 
 
 
 
                                                           
No.  

Sector 

Description / scope in current study 

Presence of benzene 

Examples of activities/ 
occupations/ exposure 
situations/  

Source 

1 

Upstream petroleum 
industry 

Crude oil production 

Natural gas production 

2 

Downstream 
petroleum industry  

Refineries (processing crude oil and 
natural gas) 

Steam crackers 

Aromatics extraction units  

Manufacturers of refined petroleum 
products  

Benzene is a natural component of crude oil and natural 
gas/natural gas liquids.  

Repair, maintenance and 
exchange of valves, pumps 

The benzene content in crude oil differs between the oil 
fields. As examples, a content of 0.52% for an oilfield in 
the North Sea has been reported. Crude oil assays from 
different regions on the Norwegian continental shelf 
(n=14) showed a mean and median value of 0.28% 
benzene by weight (range <0.01–0.66%).  

Maintenance work during 
turnaround 

Tank maintenance and cleaning 

Natural gas condensate loading 

Sampling  

RAC, 2018a;  

stakeholder consultation;  

(Kirkeleit et al., 2006) 

Benzene is present in certain streams of refining and 
steam cracking output products (naphtha and pyrolysis 
gasoline).  

Benzene is extracted from benzene containing streams. 

Repair, maintenance and 
exchange of valves, pumps 

Maintenance work during 
turnaround 

RAC, 2018a; ECHA 2017a; 

HVBG, 2002 

Tank maintenance and cleaning 

Loading and unloading of 
benzene or benzene containing 
streams, e.g. naphtha, petrol 

Sampling  

Fugitive emissions 

3 

Coking plants 

Coking plants are often located in 
vicinity to sites of iron and steel 
production. Coke is used as metallurgical 
coke in blast furnaces for metal smelting 
or for heating. To a lesser extent, coke is 
produced for heating purposes.  

Benzene is a by-product in the coking of hard coal.  

Benzene is recovered from coke oven gas and tar. 

Maintenance work on the coke 
oven battery 

RAC, 2018a,  

HVBG, 2002; 

Maintenance work in the by-
product plant  

Fugitive emissions  

stakeholder consultation 

4 

Petrochemical 

Chemical manufacturers use benzene as 

Pure benzene is used as a raw material for manufacture of 

Tank maintenance and cleaning 

RAC, 2018a; stakeholder 

132 

 
 
 
 
No.  

Sector 

Description / scope in current study 

Presence of benzene 

Examples of activities/ 
occupations/ exposure 
situations/  

Source 

industry 

5 

Distribution  

intermediate in the production of basic 
chemicals such as ethylbenzene, 
cumene, cyclohexane, nitrobenzene, 
alkylbenzene and others derivatives. 
Ethylbenzene accounts for almost half of 
the benzene intermediate consumption. 
These substances are further used for 
the manufacture of plastics, synthetic 
rubber, dyestuffs, resins, raw materials 
for detergents, and plant protection 
agents.  

In some respects, steam crackers or 
aromatics extraction plants are 
considered as petrochemical industry. 
However, in the current assessment, 
these users of benzene-containing 
streams are considered in the 
downstream petroleum sector.  

Distribution of benzene, petrol and 
benzene-containing streams from 
manufactures via bulk storage sites to 
users by means of road, rail and ship 
transport. 

basic chemicals 

Styrene production 

consultation 

Loading and unloading of 
benzene  

Sampling  

Fugitive emissions 

Benzene, petrol and benzene-containing streams  

Tank maintenance and cleaning 

RAC, 2018a; 

Tank filling  

Sampling 

Road tanker driver 

HVBG, 2002; stakeholder 
consultation 

6  

Retail and petrol 
stations 

Sale of fuels to consumers and 
professionals 

Benzene may be contained up to 1% v/v in petrol as an 
anti-knocking agent. Before 2000, the concentration of 
benzene in petrol was usually 2% or higher. 

Filling assistants at petrol 
stations (primarily Southern 
Europe)  

DGUV, 2018; stakeholder 
consultation 

Pump calibration and 
maintenance 

7 

Maintenance and 

Repairing workshops for cars, ships, 

Benzene may contained up to 1% v/v in petrol. 

Use of petroleum-based 

RAC, 2018a; 

133 

 
 
No.  

Sector 

Description / scope in current study 

Presence of benzene 

Examples of activities/ 
occupations/ exposure 
situations/  

Source 

repair of motor 
vehicles  

airplanes and other vehicles 

Petroleum-based products containing benzene. 

products 

Tank filling  

HVBG, 2002;  

Breuer et al., 2015 

8 

Foundries 

Casting and moulding 

Benzene may be formed and emitted during pyrolysis of 
organic binders 

Sand plant 

Casting  

BGIA 2009, stakeholder 
consultation 

9 

Several sectors  

Exposure to benzene from exhaust of 
vehicles/equipment 

Benzene is formed during incomplete combustion 
processes, e.g. petrol combustion 

10 

Laboratories - 
Research, 
development and 
education 

Within the petroleum/petrochemical 
industry, sampling and analysis of 
benzene-containing streams is an 
integrated part of the business.  

Benzene may be used as a solvent or be present in 
samples 

Small quantities of benzene are used as 
a laboratory reagent and solvent. This 
use is declining, however, benzene does 
occur in small quantities in various 
solvents on a hydrocarbon basis 

Traffic policeman  

RAC, 2018a; 

Filling assistants at petrol 
stations (primarily Southern 
Europe) 

Landscape and forestry workers 
using petrol-engined 
equipment 

Taxi drivers 

Lab technician 

Breuer et al., 2015 

RAC, 2018a 

EU RAR, 2008 

11-
15 

Other sectors 

Printing industry 

Shoe manufacture 

Petroleum-based products containing benzene as a 
solvent or as impurity, e.g. lacquers, paints, glues, inks. 

Historically relevant, present 
exposures in EU significantly 
reduced/ not present: 

RAC, 2018a; 

Armold et al., 2013 

134 

 
 
 
 
No.  

Sector 

Description / scope in current study 

Presence of benzene 

Service sector 

Rubber manufacture and surface 
treatment 

Manufacture of artificial leather  

Examples of activities/ 
occupations/ exposure 
situations/  

Source 

Surface cleaning with 
petroleum solvents  

Painting with lacquer  

Various printing operations  

Use of mineral spirits (spray 
cleaning and degreasing) 

135 

 
Table 69 - Relevant NACE codes for key sectors 

Sector 

NACE code 

Upstream petroleum industry 

B 6.1 Extraction of crude petroleum 

Downstream petroleum industry: Refineries 

C 19.2 Manufacture of refined petroleum products 
(partly) 

Coking plants 

C 19.1 Manufacture of coke oven products 

Petrochemical industry 

Distribution of petroleum products 

C 20.14 Manufacture of other organic basic chemicals 
(partly)  
C 19.2 Manufacture of refined petroleum products 
(partly) 

H492 Freight rail transport  
H494 Freight transport by road and removal services  
H495 Transport via pipeline 
H502 Sea and coastal freight water transport  
H504 Inland freight water transport  
H512 Freight air transport and space transport  
H52 Warehousing and support activities for 
transportation 

Retail and petrol stations 

G 47.3 Retail sale of automotive fuel in specialised stores 

Maintenance and repair of vehicles 

G 45.2 Maintenance and repair of motor vehicles 

Foundries 

Laboratories 

Other industries 

C24.5 Casting of metals 

M71.2.0 Technical testing and analysis 

N 81.2 Cleaning activities 

C 20.3 Manufacture of paints, varnishes and similar 
coatings, printing ink and mastics 

Estimates  have  been  made  of  the  number  of  companies  operating  with  benzene  across  the 
EU28 Member States. The Member States with several relevant companies are (in alphabetical 
order)  Germany,  Italy,  France,  Poland  and  Spain.  For  many  of  the  affected  sectors,  the 
companies are distributed across all Member States.  

The  distribution  of  companies/sites  across  all  the  sectors  and  Member  States  are  displayed 
below. For the two sectors "Maintenance and repair of vehicles and "Distribution" the split by 
Member State is based on population shares. 

Table 70: Share of companies by Member State in each sector/indusry  

136 

 
 
 
 
 
Upstream 

Downstream 

Coking plants 

Petrochemic

Retail and 

Foundries 

Remaining 

petroleum 

petroleum 

al industry 

gas stations 

two  

sectors* 

Austria 

0.0% 

1.3% 

4.0% 

0.0% 

0.0% 

0.9% 

1.7% 

Belgium 

0.0% 

3.9% 

3.0% 

4.4% 

0.1% 

1.6% 

2.2% 

Bulgaria 

0.0% 

1.3% 

0.0% 

0.0% 

7.3% 

1.8% 

1.4% 

Cyprus 

0.0% 

0.0% 

0.0% 

0.0% 

0.6% 

0.0% 

0.2% 

Croatia 

0.0% 

1.3% 

0.0% 

0.0% 

0.0% 

1.2% 

0.8% 

The Czech 

Republic  

0.0% 

2.6% 

6.0% 

0.0% 

0.0% 

12.9% 

2.1% 

Denmark 

18.0% 

2.6% 

0.0% 

0.0% 

0.1% 

0.8% 

1.1% 

Estonia 

0.0% 

0.0% 

0.0% 

0.0% 

0.4% 

0.2% 

0.3% 

Finland 

0.0% 

2.6% 

2.0% 

1.7% 

1.5% 

0.7% 

1.1% 

France 

0.0% 

9.1% 

8.0% 

10.2% 

15.1% 

5.7% 

13.1% 

Germany 

2.1% 

14.3% 

24.0% 

29.6% 

0.0% 

13.6% 

16.2% 

Greece 

0.5% 

5.2% 

0.0% 

0.0% 

17.0% 

1.7% 

2.1% 

Hungary 

0.0% 

1.3% 

2.0% 

0.0% 

0.1% 

2.7% 

1.9% 

Ireland 

0.0% 

1.3% 

0.0% 

0.0% 

4.6% 

1.0% 

0.9% 

Italy 

0.6% 

11.7% 

5.0% 

6.8% 

0.0% 

18.7% 

11.8% 

Latvia 

0.0% 

0.0% 

0.0% 

0.0% 

1.3% 

0.1% 

0.4% 

Lithuania 

0.0% 

1.3% 

0.0% 

0.0% 

0.2% 

0.2% 

0.5% 

Luxembourg 

0.0% 

0.0% 

0.0% 

0.0% 

0.0% 

0.0% 

0.1% 

Malta 

0.0% 

0.0% 

0.0% 

0.0% 

0.2% 

0.0% 

0.1% 

Netherlands 

1.4% 

7.8% 

6.0% 

27.7% 

0.0% 

1.9% 

3.4% 

137 

 
  
Upstream 

Downstream 

Coking plants 

Petrochemic

Retail and 

Foundries 

Remaining 

petroleum 

petroleum 

al industry 

gas stations 

two  

sectors* 

Poland 

0.5% 

2.6% 

25.0% 

0.0% 

0.2% 

8.4% 

7.4% 

Portugal 

0.0% 

2.6% 

0.0% 

0.6% 

8.3% 

2.4% 

2.0% 

Romania 

1.4% 

2.6% 

0.0% 

0.0% 

5.9% 

2.8% 

3.8% 

Slovakia 

0.0% 

1.3% 

4.0% 

0.0% 

0.3% 

1.0% 

1.1% 

Slovenia 

0.0% 

0.0% 

0.0% 

0.0% 

0.5% 

1.3% 

0.4% 

Spain 

0.5% 

11.7% 

4.0% 

7.2% 

30.5% 

8.8% 

9.1% 

Sweden 

0.0% 

3.9% 

3.0% 

0.0% 

0.2% 

2.0% 

2.0% 

United Kingdom 

75.0% 

7.8% 

4.0% 

11.7% 

5.6% 

7.5% 

12.9% 

* Maintenance and repair of vehicles and distribution 

3.2.  Exposed workforce 

3.2.1.  Published sources 

EU CAREX data 

The  CAREX  (CARcinogen  EXposure)  data  for  Europe  show  an  exposed  workforce  of  about  1.4 
million workers distributed on 43 different industries131. The table below shows the number of 
workers exposed to benzene in 1991-1993 (EU15), supplemented with data from 1997 for four 
additional MS (Estonia, Czech Republic, Latvia and Lithuania).  

The  industries  with  the  largest  number  of  exposed  workers  are  personal  and  household 
services, wholesale and retail trade and restaurants and hotels, land transport, manufacture of 
plastic products not elsewhere classified and iron and steel basic industries.  

Notably, the CAREX data does not include any category for automotive repair and maintenance, 
the main category in the Canada CAREX database as shown below.  

Table 71 - CAREX EU estimate on workers exposed to benzene 1993/1997 (for countries where 
data from 1993 were unavailable data from 1997 were used instead) 

Industry 

No. of workers 

131 CAREX EU, available at https://www.ttl.fi/wp-content/uploads/2018/01/EU_5_exposures_by_agent_and_industry.pdf 

138 

 
  
 
 
 
                                                           
Industry 

Personal and household services  

Wholesale and retail trade and restaurants and hotels 

Land transport 

Manufacture of plastic products not elsewhere classified 

Iron and steel basic industries 

Manufacture of other chemical products 

Manufacture of industrial chemicals 

Manufacture of machinery except electrical 

Construction 

Education services 

Manufacture of fabricated metal products, except  

Petroleum refineries 

Financing, insurance, real estate and business services 

Agriculture and hunting 

Sanitary and similar services 

Water transport 

Research and scientific institutes 

Printing, publishing and allied industries 

Crude Petroleum and Natural Gas Production 

Medical, dental, other health and veterinary services 

Manufacture of furniture and fixtures  

Manufacture of wood and wood and cork products 

Manufacture of electrical machinery, apparatus, appliance 

Electricity, gas and steam 

Services allied to transport 

Manufacture of transport equipment 

Manufacture of textiles 

Manufacture of miscellaneous products of petroleum  

Other manufacturing industries 

Manufacture of footwear 

139 

No. of workers 

942,495 

248,303 

42,848 

16,987 

14,934 

12,721 

12,498 

9,600 

8,300 

7,387 

6,800 

6,783 

5,250 

4,980 

4,613 

3,001 

2,752 

2,390 

1,636 

1,620 

1,602 

1,257 

1,091 

1,060 

1,013 

1,000 

881 

682 

489 

400 

 
Industry 

Air transport 

Food manufacturing 

Manufacture of paper and paper products 

Manufacture of wearing apparel, except footwear 

Manufacture of rubber products 

Water works and supply 

Manufacture of other non-metallic mineral products 

Manufacture of leather and products of leather  

Non-ferrous metal basic industries 

Recreational and cultural services 

Manufacture of instruments, photographic and optical  

Tobacco manufacture 

Beverage industries 

TOTAL NUMBER OF WORKERS 

NUMBER OF INDUSTRIES 

CAREX Canada data 

No. of workers 

293 

288 

284 

250 

250 

200 

198 

189 

162 

120 

87 

53 

6 

1,367,753 

43 

CAREX Canada132 estimates the number of exposed workers in Canada at 375,000 making up 2% 
of  the  Canadian  population.  Based  on  a  population  of  513  million  people  in  the  EU,  the 
corresponding figure  of exposed workers  in the EU would be  10 million if a similar per-capita 
ratio is assumed. Of these, 88% of the exposed are men and only 12% are women. The CAREX 
Canada  data  lists  the  five  most  significant  exposure  industries  as  shown  below.  Public 
administration is mentioned as a significant  industry, because firefighters belong under public 
administration  in  Canada  and  firefighters  are  exposed  to  benzene  during  smoke  diving. 
However, the use of RPE during firefighting operations is mandatory, and exposure data to not 
indicate that firefighters are a relevant exposure group.  

Table 72 - CAREX Canada estimate on workers exposed to benzene  

Industry 

No. of workers in Canada 

% of total exposed workforce 

Automotive repair and 
maintenance 

40,000 

11% 

132 CAREX Canada, available at https://www.carexcanada.ca/en/benzene/occupational_estimate/  

140 

 
 
 
                                                           
Taxi and limo service 

Printing and related support 
activities 

Public administration (incl. 
firefighters) 

Automobile dealers 

Others 

TOTAL NUMBER OF WORKERS 

Finnish ASA register 

30,000 

28,000 

27,000 

15,000 

235,000 

375,000 

8% 

7% 

7% 

4% 

63% 

100% 

In the Finnish ASA register133, the data indicate that about 2,000 workers in Finland are exposed 
to  benzene,  the  majority  are  men  (95%).  The  largest  exposed  occupations  are  motor  vehicle 
installers and repairers, office cleaning personnel etc. and agricultural and industrial machinery 
installers and repairers. Based on a population of 5.5 million in Finland and 513 million people in 
the EU, the corresponding figure  of exposed workers would be 190,600 in the EU if the same 
per-capita ratio was assumed. 

Table 73 - Finnish ASA estimate on workers exposed to benzene (ASA, 2014) 

Occupation 

Men 

Women 

TOTAL 

Motor vehicle installers and repairers 

Office cleaning personnel etc. 

Agricultural and industrial machinery installers and repairers 

Process workers in the plastics industry 

Aircraft installers and repairers 

Freight forwarders, warehouse workers and others. 

Non-commissioned officers 

Officers 

Laboratory workers 

Drivers of trucks and special vehicles 

Other professions 

TOTAL NUMBER OF WORKERS 

% OF TOTAL NUMBER OF WORKERS 

229 

207 

183 

153 

141 

107 

85 

73 

29 

56 

672 

1,935 

95% 

9 

7 

0 

9 

2 

0 

0 

0 

30 

0 

51 

108 

5% 

238 

214 

183 

162 

143 

107 

85 

73 

59 

56 

723 

2,043 

100% 

133 ASA (2014), ASA 2014 Syöpäsairauden vaaraa aiheuttaville aineille ja menetelmille ammatissaan altistuneiksi ilmoitetut 
Suomessa. TYÖTERVEYSLAITOS HELSINKI. Available at : http://www.julkari.fi/handle/10024/131073 

141 

 
 
 
                                                           
Italian occupational exposure estimates 

Scarselli et al.134 evaluated a total of 16,271 benzene exposure measurements from the Italian 
carcinogen exposure database SIREP from the period 1996-2007. In the database, information 
about the companies (economic activity sector, geographical location and workforce size), the 
worker (demographic data and occupational characteristics) and exposure (carcinogenic agent, 
magnitude, frequency and duration) is recorded.  

The  overall  arithmetic  mean  of  measurements  was  0.09  ppm  and  the  geometric  mean  0.02 
ppm. The number of workers potentially exposed in the selected sectors was 37,137 (table 74), 
and the most  predictive  independent  variables of the  exposure  level were measurement year 
and  job  category.  The  sectors  with  the  highest  estimated  numbers  of  exposed  workers  were 
"Retail  sale  of  automotive  fuel"  (about  16,000  exposed  workers)  and  "Petroleum  refinery" 
(about 6,500 exposed workers).  

The table below lists only the sectors better characterized in the database. Certain sectors were 
excluded  because  of  the  limited  information  on  the  size  of  reported  workforce  (e.g.  "Land 
transport", "Sewage and refuse disposal" and "Maintenance and repair of motor vehicles").  

Table 74 - Estimates on workers exposed to benzene from the Italian exposure database 
(Scarselli et al., 2011) 

No. of companies 

% of worker exposed 

No. of workers exposed 

15 

23 

12 

10 

13 

1,009 

15 

50.52 

45.44 

38.48 

3.36 

3.53 

73.22 

50.20 

2,104 

6,452 

4,321 

509 

1,870 

16,041 

5,840 

37,137 

Sector of economic 
activity 

Extraction of crude 
petroleum 

Petroleum reﬁnery 

Manufacture of other 
organic basic chemicals 

Manufacture of basic 
pharmaceutical products 

Manufacture of 
pharmaceutical 
preparations 

Retail sale of automotive 
fuel 

Wholesale of petroleum 
products and lubricants 

TOTAL NUMBER OF 
WORKERS 

French SUMER database 

134 Scarselli, A., Binazzi, A., Di Marzio, D. (2011). Occupational exposure levels to benzene in Italy: findings from a national 
database. Int Arch Occup Environ Health 84(6):617-625. 

142 

 
 
 
 
                                                           
 
Data are also reported by the The Medical Monitoring Survey of Professional Risks (Surveillance 
médicale  des  expositions  aux  risques  professionnels,  SUMER),  and  which  are  summarised  for 
the  most  recent  survey  concerning  below135.  These  data  are  extrapolations  from  a  sample  of 
workers who self-declare exposure in a survey administered by company medical officers during 
the workers’ regular compulsory medical examination. 

The database includes exposure to benzene (excl. benzene in fuels) and exposure to petrol (excl. 
specific information on benzene). 

Table 75 - Workers exposed to benzene (excl. fuels) and petrol in the SUMER survey 2010 

Group 

Total  no. 

% of 
workforce 

Duration of exposure within the 
last week 

Extent of exposure 

Not declared: 11,400 
Very low:       16,300 
Low:               8,600 
High:                  NA 
Very High:           NA 

Not declared:    90,800 
Very low:        209,600 
Low:               132,600 
High:                24,800 
Very High:          0 

Benzene (excl. benzene in fuels) 

Total 

36,900 

0.2  Without indication:  5,900 

Less than 2 h.:      19,200 
2-10 h:                   7,300 
10-20 h:                 NA 
>20 h:                    NA    

Chemical industry  

Repair of automobiles and 
motorcycles 

* 

3,300 

6,900 

Public administration 

2,600 

1.8 

0.2 

0.1 

Petrol 

Total 

458,100 

2.1  Without indication:  15,000 

Less than 2 h.:      308,000 
2-10 h:                 100,000 
10-20 h:                 14,600 
>20 h:                    20,200    

Repair of automobiles and 
motorcycles 

Agriculture 

Construction 

Teaching 

* 

164,200 

12,400 

66,800 

8,900 

Transportation and storage 

35,200 

Administrative and service 
activities 

35,100 

5.2 

5.1 

4.4 

3.1 

2.6 

2.5 

Note: Low exposure: less than 50% of OEL, High exposure: >50% of OEL, Very high exposure: may 
exceed OEL.  The current French OEL for benzene is 3,250 μg/m3 (1 ppm). 
* The sector specific data are only provided for main sectors.  

135 Vinck, L., Memmi, S. (2015) Les expositions aux risques professionnels Les produits chimiques Enquête SUMER 2010. Available 
at : 
https://dares.travail-emploi.gouv.fr/dares-etudes-et-statistiques/enquetes-de-a-a-z/article/surveillance-medicale-des-expositions-
aux-risques-professionnels-sumer-edition 

143 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
3.2.2.  Sectoral break-down 

Exposed workforce in the upstream petroleum industry 

According to stakeholder consultation, significant exposures are more likely to occur in natural 
gas  production  than  in  crude  oil  production,  as  natural  gas  condensate  contains  larger 
concentrations of benzene than crude oil. Occupational exposure settings, however, are similar 
in both productions, as well as activities leading to exposures (tank work, maintenance during 
turnaround) are comparable with exposure in the downstream petroleum sector.  

No  data  on  the  number  of  workers  exposed  in  the  upstream  sector  or  the  percentage  of  the 
workforce exposed at relevant levels been obtained from the stakeholder consultation.  

For the downstream sector, it is estimated that 36% of workers employed (based in workforce 
data provided by Eurostat) are exposed at the levels provided in the section on exposure levels. 
In the absence of specific data for the upstream sector it is estimated that the same fraction of 
the  workers  in  the  upstream  sector  undertake  are  involved  in  activities  with  high  benzene 
exposure such as tank work and maintenance during turnaround.  

Estimates  on  total  number  of  workers  and  number  of  workers  exposed  are  compiled  in  the 
below table.  

Table 76 - Data available for estimating exposed workforce in the upstream sector 

Number  

Description 

Comment 

Source of number 

 1,636  

2,104 

17,694 

65,834 

No. of exposed workers in crude 
petroleum and natural gas 
production in EU  

No. of exposed workers in extraction 
of crude petroleum and natural gas 
in Italy; service activities incidental 
to oil and gas extraction, excluding 
surveying  

According to reports in the SIREP 
database, half of the total of workers 
in the sector is exposed to benzene. 
The production of crude oil in Italy is 
very small.  

EU CAREX data 
(1993/1997) 

Scarselli et al., 2011 

No. of exposed workers in extraction 
of crude petroleum and natural gas, 
service activities incidental to oil and 
gas extraction extrapolated from 
Italian figure to the EU. 

The estimate is smaller than the 
other estimate developed for the 
whole of the EU, corresponding to 
that the production of crude oil in 
Italy is small.  

Scarselli et al., 2011 
and own 
extrapolation based 
on population 

Total number of employees in 
category B06: crude petroleum 
(40,284) and natural gas extraction 
(25,551)  

Only a fraction of the total number of 
employees will be exposed 

Eurostat, 2016 

24,000  

Eurostat estimate multiplied with 
the fraction of exposed derived from 
the downstream sector (36%) 

Justification: Comparable exposure 
situations in the downstream and 
upstream sector 

Eurostat, 2016; 
stakeholder 
consultation 

Exposed workforce in the downstream petroleum industry 

144 

 
 
 
 
 
By the end of 2017, there were about 39 benzene-producing steam cracker plants (owned by 16 
companies)  and  77  refineries  in  the  EU.  The  steam  crackers  and  the  refineries  (including 
aromatics extraction units/plants) are the main benzene (and other aromatics) producers (90-
95%  of  the  production)136.  All  of  these  companies  are  large  companies  with  more  than  250 
employees. 

According  to  Eurostat,  there  are  1,019  enterprises  within  the  NACE  category  "C192  - 
Manufacture  of  refined  petroleum  products".  Apparently,  handling  of  benzene-containing 
streams and thus exposure to benzene occurs only in a small fraction of companies producing 
refined petroleum products. 

Estimates  on  total  number  of  workers  and  number  of  workers  exposed  are  compiled  in  the 
below table.  

Comparing  the  figures  from  Eurostat  (total  number  of  workers)  and  the  Triskelion  study 
(number  of  exposed)  results  in  36%  of  workers  employed  within  the  sector  may  be 
occupationally exposed to benzene in some degree. This appears to be a reasonable percentage 
on the basis of stakeholder consultation responses own observations by companies visited. The 
estimate of 45,086 is taken on for further consideration in the cost benefit assessment. 

Table 77 - Data available for estimating exposed workforce in the downstream sector 

Number  

Description 

Comment 

Source of number 

6,783  

Petroleum refineries  

Number of exposed to benzene 

EU CAREX data (1993/1997) 

123,850 

C192 - Manufacture of refined 
petroleum products 

45,086 

Estimated for workers exposed 
in manufacture of benzene and 
benzene containing streams 
(refineries and steam crackers).  

Total number of employees in 
the sector, from 1,019 
enterprises 

Sum of  
- direct exposed workers and 
indirectly exposed workers 
- estimate is extrapolated from 
questionnaire responses to the 
whole of the EU 

Eurostat, 2016 

Triskelion study 

Exposed workforce in the coking plants 

According to estimates obtained during stakeholder consultation there are 50 coking plants in 
Europe.  Coking  plants  are  usually  medium  or  large  companies  with  around  250  workers  of 
which  half  are  exposed  to  benzene  containing  emissions.  Comparable  with  the  petroleum 
sectors,  externals may  be  hired  for  certain  maintenance  works.  Estimates on  total  number  of 
workers and number of workers exposed at compiled in the below table.  

The estimates deviate by a factor of 2. The estimate based on the number of plants obtained 
during stakeholder consultation appears more robust as it is derived from information received 
during a site visit and direct consultation with industry experts and fewer assumptions than the 
latter estimate. The first estimate is therefore used in the benefits assessment.  

136 FuelsEurope (2018). Statistical report 2018. https://www.fuelseurope.eu/wp-content/uploads/FuelsEurope-Statistical-Report-
2018.pdf 

145 

 
 
                                                           
Table 78 - Data available for estimating exposed workforce in the coking plants 

Number  

Description 

Comment 

Source of number 

6,250 

Number of exposed 
workers in coking plants 

3,142  

Number of exposed 
workers in coking plants 

Based on number of coking plants in 
EU (50), average no. of employees of 
250 per plant (including externals), 
and a fraction of 50% of exposed 

Based on European production of 
coking plants, and average 
production and fraction exposed per 
coking plant  

Stakeholder consultation 

Eurostat*; Stakeholder 
consultation 

* https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Coal_production_and_consumption_statistics 
#Supply_of_coke_oven_coke_and_deliveries_to_the_iron_and_steel_industry 

Exposed workforce in the petrochemical industry 

Around 50 chemical plants in Europe are converting benzene into various derivatives137.  

The Triskelion study estimate an average number of exposed ca. 190 FTEs per site. According to 
stakeholder consultation, there are between 30 and 50 sites in EU.   

The estimate  on FTEs  exposed provided in the  Triskelion study is rather low  compared to the 
CAREX estimate on no. of exposed workers but considered to be more precise and better reflect 
the current situation. The content of benzene in mixtures has since the mid-1990s, where the 
CAREX  study  was  undertaken,  been  restricted  and  this  has  likely  resulted  in  lowering  the 
number  of  workers  exposed  in  the  manufacture  of  some  types  of  chemicals.    The  Triskelion 
study estimate is therefore taken forward in the assessment. 

Table 79 - Data available for estimating exposed workforce in the chemical industry sector 

Number  

Description 

Comment 

Source of number 

186,493 

4,596 

C2014 - Manufacture of 
other organic basic 
chemicals 

C2014 - Manufacture of 
other organic basic 
chemicals 

Total no. of employed, all 
enterprises within category 

Eurostat, 2016 

Total no. of employed, 50 
enterprises within category 
(accounting for 2.5%) of total no. 
of employed  

Eurostat, 2016; Personal 
communication with 
Petrochemicals Europe, 2018 

12,498  

Manufacture of industrial 
chemicals  

No. of exposed  

EU CAREX data (1993/1997) 

Use of benzene as 
intermediate  

7,592  

(5,694 - 
9,490) 

Numbers from all responses on 
workers directly and indirectly 
exposed extrapolated to the EU. 
Average of 190 FTEs per site, 30-
50 sites in EU.  

Triskelion study; Petrochemicals 
Europe, 2018 

137 See footnote 18 

146 

 
 
 
 
 
                                                           
Exposed workforce in distribution 

According to stakeholder consultation, there are usually between 40 and 100 people employed 
at a bulk tank storage site with 10 – 30% of the workers exposed related to filling and loading 
activities. Estimates on total number of workers and number of workers exposed at compiled in 
the below table. The estimate of 75,230 workers in the EU, extrapolated from information for 
five MS provided by Petrochemicals Europe138, has been used for the further calculations. 

Table 80 - Data available for estimating exposed workforce in the distribution of benzene and 
benzene-containing streams 

Number  

Description 

Comment 

9,792 

No. of exposed 
workers at tank farms 

Sum of directly exposed workers and 
indirectly exposed. 
Numbers from all responses (n=64) of the 
industry SEA survey, no extrapolation to 
the EU was done. 

Source of number 

Triskelion study 

1,250 

3,582 

25,000 

71,648 

26,250 

75,230 

No. of exposed 
workers at tank farms 

Estimate for DE, FR, BE, NL, LU. Not 
extrapolated to EU. 

Personal communication with 
Petrochemicals Europe, 2018 

No. of exposed 
workers at tank farms 
in EU 

Estimate for DE, FR, BE, NL, LU 
extrapolated to the EU based on 
population 

Personal communication with 
Petrochemicals Europe, 2018 

No. of exposed tank 
drivers  

Estimate for DE, FR, BE, NL, LU. Not 
extrapolated to EU. 

Personal communication with 
Petrochemicals Europe, 2018 

No. of exposed tank 
drivers in EU 

Estimate for DE, FR, BE, NL, LU 
extrapolated to the EU based on 
population 

Personal communication with 
Petrochemicals Europe, 2018 

No. of exposed 
workers at tank farms 
and tank drivers 

Estimate for DE, FR, BE, NL, LU. Not 
extrapolated to EU.  

Personal communication with 
Petrochemicals Europe, 2018 

No. of exposed 
workers at tank farms 
and tank drivers in EU 

Estimate for DE, FR, BE, NL, LU 
extrapolated to the EU based on 
population 

Personal communication with 
Petrochemicals Europe, 2018 

Exposed workforce in the retail and petrol stations 

By  the  end  of  2017,  there  were  74,340  petrol  stations  in  the  EU  MS139.  Estimates  on  total 
number of workers and number of workers exposed at compiled in the below table.  

Scarselli et al. (2011)140 estimate that 16,041 workers in “retail sale of automobile fuel” may be 
exposed to benzene representing 73% of the workers in the stations in Italy. Extrapolated to the 
entire EU on a per capita basis, the total would correspond to approximately 140,000.  

138 See footnote 18 
139 See footnote 18 
140 See footnote 134 

147 

 
 
  
 
 
 
 
 
                                                           
In  the  majority  of  the  MS,  today  filling  assistants  are  not  used.  According  to  Concawe,  filling 
assistants are used in 5% of the petrol stations across the EU. It is for the calculations assumed 
that  5%  of  the  total  staff  reported  for  NACE  code  G473,  “Retail  sale  of  automotive  fuel  in 
specialised stores” may be filling assistants, resulting in 21,600 exposed workers. This estimate 
is taken on in the assessment. 

Table 81 - Data available for estimating exposed workforce in the fuel retail and petrol 
stations 

Number  

Description 

Comment 

Source of number 

430,000 

G473 - Retail sale of 
automotive fuel in specialised 
stores  

Total no. of employed, all 
enterprises within category 

Eurostat, 2016 

140,000 

Exposed workers at petrol 
stations 

21,600 

Exposed workers at gas 
stations (attendants and pump 
calibration) 

Scarselli et al., 2011 

Eurostat, 2016, Stakeholder 
consultation 

Based on numbers of 
workers exposed in Italy, 
extrapolated to the EU on 
per capita basis 

No. of exposed workers 
comprising 5% of total 
employees and an 
additional number of pump 
maintenance workers (1 
worker per 1000 pumps) 

Exposed workforce in maintenance and repair of motor vehicles 

Estimates on total number of workers and number of workers exposed at compiled in the below 
table. The Finnish ASA database indicates 248 exposed in Finland whereas the Finnish register of 
biological  monitoring  indicates  that  “Car  maintenance  and  repair  work  employs  about  8,000 
people, some of whom may be exposed to benzene”141.  

For the sector “Repair of automobiles and motorcycles”, the French SUMER Database estimates 
that 6,900 workers are exposed to benzene (excl. benzene in petrol) while 164,200 workers are 
exposed to petrol.  

Eurostat lists a total of 1.57 million workers employed within "Maintenance and repair of motor 
vehicles". It will for the  further estimations be assumed that half of the workers in the  sector 
are  exposed  at  the  levels  reported  under  exposure  concentrations  corresponding  to  785,000 
workers. The percentage is based on the authors’ own observations in Denmark. The challenge 
in  estimating the  number of exposed workers  from Eurostat  data  on  total  workforce  within  a 
sector is to define the number of workers involved in those exposure groups represented by the 
available  exposure  data.  Data  extrapolated  on  a  per  capita  bases  from  data  for  Canada  and 
France would result in about 50% higher numbers, whereas data extrapolated from Finnish data 
result in much lower numbers.  

141  Kiilunen,  M.  (2012):  Biological  monitoring  –  annual  statistics  2012,  Finnish  Institute  of  Occupational  Health. 
https://www.julkari.fi/bitstream/handle/10024/135070/Biological%20monitoring.pdf?sequence=1 

148 

 
 
                                                           
 
Table 82 - Data available for estimating exposed workforce in the maintenance and repair of 
motor vehicles 

Number  

Description 

Comment 

Source of number 

1,569,416  

G452 - Maintenance and 
repair of motor vehicles  

Total no. of employed, all enterprises 
within category 

Eurostat, 2016 

784,708  

Exposed workers in 
maintenance and repair 
of motor vehicles 

Based on Eurostat data assuming 50% 
of the people employed exposed 

Eurostat, 2016; own estimate 

238 

Exposed in Finland, 2014 

EU28 (per capita estimate): 21,983  

ASA database 

40,000 

Automotive repair and 
maintenance, number of 
exposed workers in 
Canada 

164,200 

Exposed to petrol in 
France 

EU28 (per capita estimate): 1,094,400 

CAREX Canada 

EU28 (per capita estimate): 1,254,000 

SUMER database 

Exposed workforce in the foundries 

Estimates on total number of workers and number of workers exposed have been received from 
the European foundry association (CAEF), see below table. According to CAEF, about one third 
of all workers within the foundry sector are potentially exposed.  

The EU CAREX does not specifically include foundries but indicates 14,934 exposed persons in 
“Iron and steel basic industries”. 

Table 83 - Data available for estimating exposed workforce in the foundries 

Number  

Description 

Comment 

Source of number 

154,600 

Employed workers in foundries 

Total no. of employed 

Stakeholder consultation 

49,000 

Potentially exposed workers in 
foundries 

202,924 

Employed workers in foundries 

No. of exposed 

Stakeholder consultation 

Total no. of employed in  
Casting of metals (code 
24.5) 

Eurostat, 2016 

68,000 

Potentially exposed workers in 
foundries 

No. of exposed 

Eurostat, 2016; Stakeholder 
consultation 

Exposed workforce in laboratories 

Exposures  in  production  laboratories  are  generally  low,  whereas  in  R&D  facilities  occasionally 
more  elevated  exposures  occur  during  petrol  handling,  an  activity  which  may,  however,  be 
infrequent. 

Among  laboratory  workers  only  those  employed  in  R&D  facilities  and  engaged  in  test  fuel 
blending may have occasional elevated exposure to petrol vapour.  

149 

 
 
 
As described in the next section, the EU CAREX indicates that 2,752 workers in R&D institutions 
may  be  exposed  to  benzene.  The  Finnish  ASA  database  indicates  59  laboratory  workers  may 
potentially  be  exposed  to  benzene  in  Finland  in  2014  (extrapolated  to  the  EU  it  may 
approximately  be  6,000).  As  the  available  exposure  data  represents  only 
laboratories 
technicians  involved  in  the  processes  described  above,  the  actual  number  of  technicians 
exposed  at  elevated  levels  in  estimated  to  be  significantly  lower  than  the  total  number  of 
potentially exposed technicians. 

Table 84 - Data available for estimating exposed workforce in the R&D petrochemical 
laboratories 

Number  

Description 

Comment 

Source of number 

2,752 

Exposed workers in R&D 
institutions 

Comprising R&D 
personnel from all 
sectors 

EU CAREX data (1993/1997) 

6,000 

Laboratory workers 

500 

Exposed workers in R&D 
laboratories in the petroleum 
sector 

Extrapolated to the EU 
from Finnish ASA 
estimate 

ASA, 2014 

Own estimate 

Exposed workforce in other occupations 

A large number of workers may potentially be exposed at low levels in a number of occupations 
which may be divided on:  

  Exposure to low levels of benzene in paints, adhesives, sealants, printing inks.  

  Exposure  to  benzene  in  ambient  air  in  city  areas  with  high  traffic,  or  exposure  to 

benzene generated by fires.  

Very limited data are available on 8h TWA for these occupations. Available data for short term 
exposure shows that exposure levels may be well above a threshold level of 0.05 ppm, but the 
data indicates that likely a very small part of the workers may be regularly exposed at 8h TWA 
levels above the 0.05 ppm. It is considered that the exposure levels are very low as compared to 
the levels e.g. in the petrochemical sector and the actual number of workers exposed at a level 
above  the threshold has not  been quantified because  the contribution from this group to the 
total benefits and costs is estimated be very low as compared to the effects on other sectors. As 
the threshold for health effects  is 0.05 ppm, this group of workers, even the number is large, 
will not contribute significantly to the total body burden. 

The  number  of  workers  potentially  exposed  at  low  levels  below  the  assessment  levels  of  this 
study is considered to be very high as a high number of workers on a regular basis or from time 
to  time  use  mixtures  with  low  levels  of  benzene.  The  EU  CAREX  data  indicates  that  about 
940,000 workers within personal and household services may be exposed to benzene. The high 
number  from  this  occupation  is  not  confirmed  by  other  surveys,  but  the  Finnish  ASA  register 
indicates that 214 office cleaning personnel, etc. may be exposed to benzene (more than 20,000 
if extrapolated to the entire EU). Besides, the CAREX database include a number of occupations 

150 

 
 
 
where  the exposure  to benzene  is due  to low  levels in applied mixtures such as construction, 
manufacture of furniture, manufacture of textiles, manufacture of wood products, etc.  

The  CAREX  Canada  indicates  a  large  number  of  exposed  workers  in  Canada  within  the 
occupations taxi and limo service (may be both benzene in petrol and ambient city air), printing 
and related support activities and public administrations (e.g. firefighters). The available data do 
not  allow  for  a  very  certain  estimate  of  the  total  number  of  workers  potentially  exposed  at 
levels  below  the  assessment  levels,  but  it  may  likely  be  in  the  200,000  -  2,000,000  range. 
Workers within many of these occupations may have been exposed to significantly higher levels 
before  the  restrictions  of  benzene  in  products  went  into  force,  and  may  have  contributed 
significantly to the total occupational health effects of benzene.  

3.2.3.  Summary on workers exposed 

The  data  collected  through  consultation  for  this  study  provides  evidence  of  around  1  million 
workers are currently exposed to benzene. The table below gives an overview of the exposure 
concentrations and number of exposed workers taken forward for the model calculations.  

The  exposure  data  presented  in  the  below  table  is  compiled  on  data  from  both  published 
sources  and  stakeholder  consultation.  Mean  and  median  concentrations  were  calculated  by 
taking  simple  (arithmetic)  means  of  available  mean  and  median  data.  95th  percentiles  were 
calculated  based  on  average  relationships  between  mean  and  95th  percentiles  from  datasets 
were both mean and 95th percentiles were available. All exposure values were given the same 
weight irrespective of number of samples, as the number of samples is not representative for 
the occurrence of certain exposures. This approach may contribute to a conservative estimation 
of exposure concentrations, as there is a tendency that measurements are more often taken in 
high exposure situations compared to low exposure situations.  

Short-term  measured  data,  e.g.  10  min  measurements  during  loading  of  a  truck,  have  been 
omitted.  The  below  exposure  concentration  estimates  are  therefore  mostly  based  on  longer 
term measurements (e.g. 60 – 380 min) or full shifts, thus being representatives for 8-h TWA. In 
a  few  cases,  sampling  duration  is  not  known.  In  case  that  such  values  are  actually  only 
descriptive  for  short-term  exposure,  they  will  contribute  to  a  conservative  estimation  of 
exposure concentrations values used as input data for the model calculations.  

It  is  assumed  that  the  exposed  workers  are  lognormal-distributed over  the  range  of  exposure 
concentrations,  and  the  below  data  have  been  used  to  fit  a  lognormal  distribution  for  each 
sector. 

Apart from the sectors listed in the table below, it cannot be excluded that exposures exceeding 
the  OEL  of  0.05  ppm  proposed  by  RAC  may  also  occur  in  other  sectors,  for  examples  in 
manufacture  of  glues  and  adhesives,  car  painting  or  shoe  manufacturing.  Presently  available 
data  indicate  that  elevated  exposures  mostly  occur  as  short-term  exposures,  and  that  the 
number  of  workers  subject  to  elevated  long-term  exposures  not  relevant.  Sectors,  where 
exposure  may  occur  due  to  use  of  benzene-containing  products  (e.g.  paints,  inks,  adhesives, 
mineral spirits) are therefore not included in the further calculations.  

Table 85 - Exposure data used for the calculation of cases 

151 

 
 
Sector 

Exposure concentration (µg/m³) representative for 8-h TWA*  

No. of exposed workers 

Mean ** 

Median 

95th percentile 

Upstream petroleum 
industry 

Downstream petroleum 
industry 

Coking plants 

Petrochemical industry  

Distribution  

Retail and petrol 
stations  

Maintenance and repair 
of motor vehicles 

Foundries 

Laboratories 

TOTAL 

1,040 

510 

1,030 

420 

680 

180 

170 

1,220 

250 

65 

221 

150 

65 

250 

40 

55 

500 

80 

3,250**** 

24,000 

1,463 

3,250**** 

1,300 

1,944 

500 

450 

3,250*** 

726 

45,000 

6,250 

7,592 

75,200 

21,600 

785,000 

49,000 

500 

1,012,500 

* Aggregated concentrations data based on published data (see section 4.4.1) and data obtained during 
stakeholder consultation (not presented here). 
** Calculated from the log-normal distributions fitted on the basis of the median and 95th percentile.  
*** The 90th percentile is 3,160 and the 95th is set at the existing OELV of 3,250 µg/m³. 
**** Available data indicated a higher 95th percentile than the existing OELV of 3,250 µg/m³. For the 
estimations it is assumed that the companies are in compliance with the existing OELV and the 95th is set 
at the existing OELV. 

152 

 
 
 
 
 
 
 
 
 
 
 
 
Annex 7: Route(s) of exposure, adverse health effects 

Acrylonitrile 

Routes of exposure and uptake142 

The primary route of exposure to acrylonitrile for the worker population is through inhalation, 
although  exposure  can  also  occur  through  dermal  contact143.  Indeed,  SCOEL144  note  that  the 
high  potential  for  acrylonitrile  to  penetrate  skin  can  lead  to  a  high  risk  of  accidents.  Strict 
controls for the handling of the compound in the workplace are therefore required. The effects 
following exposure to acrylonitrile may be local at site of contact or systemic following exposure 
via inhalation or dermal routes. 

Adverse health effects 

Acrylonitrile has a harmonised classification as carcinogenic (Carc 1B145) under the Classification, 
Labelling and Packaging (CLP) regulation146. According to the International Agency for Reasearch 
on  Cancer147,  there  is  “inadequate  evidence  in  humans  for  the  carcinogenicity  of  acrylonitrile. 
There is sufficient evidence in experimental animals for the carcinogenicity of acrylonitrile”148. In 
consequence, acrylonitrile is classified as possibly carcinogenic to humans (Group 2B149) by IARC. 

Primary  target  for  acrylonitrile  toxicity  is  the  central  nervous  system.  The  main  concern  is 
carcinogenicity  in  the  brain,  but  acrylonitrile  is  also  acutely  neurotoxic.  In  animal  studies, 
acrylonitrile was found to be a multiple-site carcinogen. Acrylonitrile also causes local irritation 
of the skin, eyes and respiratory tract as well as skin sensitization150. 

Nickel compounds 

Routes of exposure and uptake 

The primary route of exposure for the worker population is by dermal contact or by inhalation 
of aerosols, dusts, fumes, or mists containing nickel. Dermal contact may also occur with nickel 
solutions,  such  as  those  used  in  electroplating,  nickel  salts,  and  nickel metal or  alloys.  Nickel-

in 

the 

workplace. 

ECHA/RAC/O-0000001412-86-187/F. 

142  ECHA  (2018),  Background  document  in  support  of  the  Committee  for  Risk  Assessment  (RAC)  evaluation  of  limit  values  for 
acrylonitrile 
at: 
Available 
https://echa.europa.eu/documents/10162/13641/acrylonitrile_bg_annex1_en.pdf/600bc12b-f2b4-16f6-0164-25153b48743d 
143 Scelo (2004) et al., “Occupational exposure to vinyl chloride, acrylonitrile and styrene and lung cancer risk (Europe)”.  
144  SCOEL  (2003),  “Recommendation  from  Scientific  Committee  on  Occupational  Exposure  Limits  for  Acrylonitrile”. 
SCOEL/SUM/104, December 2003. 
145 A category 1B (Carc1B) is a substance which is presumed to have carcinogenic potential for humans 
146  Regulation  (EC)  No  1272/2008  on  classification,  labelling  and  packaging  of  substances  and  mixtures.  Available  at:  https://eur-
lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32008R1272 
147 The  International Agency for Research on Cancer (IARC) is part of the World Health Organization. IARC coordinates and 
conducts both epidemiological and laboratory research into the causes of human cancer.  
148  IARC  (1999),  “Monographs  on  the  evaluation  of  carcinogenic  risks  to  humans:  re-evaluation  of  some  organic  chemicals, 
hydrazine 
https://monographs.iarc.fr/wp-
Volumn 
content/uploads/2018/06/mono71.pdf 
149 Possibly carcinogenic to humans 
150 See footnote 142 

71)”.  Available 

hydrogen 

peroxide 

(Part 

1-3, 

and 

at: 

153 

 
 
                                                           
containing  dust  may  be  ingested  where  poor  work  practices  exist  or  where  poor  personal 
hygiene is practiced151. 

Adverse health effects 

According  to  IARC,  there  is  “sufficient  evidence  in  humans  for  the  carcinogenicity  of  mixtures 
that include nickel compounds and nickel metal.  These agents cause cancers of the lung and of 
the nasal cavity and paranasal sinuses” and “in view of the overall findings in animals, there is 
sufficient  evidence  in  experimental  animals  for  the  carcinogenicity  of  nickel  compounds  and 
nickel metal.  Nickel compounds are carcinogenic to humans (Group 1152)”153. 

The primary target for nickel toxicity after inhalative exposure is the respiratory tract, especially 
the lung.  Epidemiological studies associate occupational exposure to nickel with an increased 
risk to develop lung cancer, fibrosis and to a lesser extent nasal cancer.  In experimental animals 
chronic inflammation of the lung and fibrosis were also observed.  Nickel is also a skin sensitizer 
and,  although  uncommon,  a  respiratory  sensitizer.    In  animal  studies,  nickel  also  had  adverse 
reproductive effects on both fertility and development154. 

Benzene 

Routes of exposure and uptake155 

Benzene is readily absorbed by all routes (inhalation, dermal and oral), of which inhalation is the 
most important route of occupational exposure. Mean inhalation absorption has been reported 
in humans ranging from approximately 50 to 80%156. 

Dermal absorption of benzene vapour is possible. However, the uptake is small compared to the 
uptake via inhalation157. 

Liquid  benzene  can  be  absorbed  through  human  skin,  although  this  is  not  as  substantial  as 
absorption  following  inhalation  or  oral  exposure.  Under  normal  condition  the  contribution  of 
dermal uptake to total uptake might be low as evaporation from the skin surface will decrease 
the dermally absorbed amount. However, the dermal route can be an important contributor to 
total benzene exposure in certain situations, such as immersion of the skin in solution or when 
the airborne concentration of benzene is very low158. 

151 See footnote 116 
152 IARC classification: carcinogenic to humans 
153  IARC  (1999),  “Nickel  and  nickel  compounds  (updated  26  July  2017)  monographs  on  the  evaluation  of  carcinogenic  risks  of 
chemicals to humans (Volumn 100c)”. Available at: https://monographs.iarc.fr/wp-content/uploads/2018/06/mono100C-10.pdf 
154 See footnote 18 
155 See footnote 22 
156  Dutch  Expert  Committee  on  Occupational  Safety  of  the  Health  Council  of  the  Netherlands  (2014),  “Benzene,  Health-based 
recommended occupational exposure limit”. No. 2014/3. Available at: https://www.gezondheidsraad.nl/en/task-and-procedure/areas-
of-activity/healthyworking-conditions/benzene-health-based-recommended 
157 RAUMA et al. (2013), “Predicting the absorption of chemical vapours”. Advanced Drug Delivery Reviews 65:306-14. 
158 WILLIAMS et al. (2011), “Dermal absorption of benzene in occupational settings: estimating flux and applications for risk 
assessment”. Crit Rev Toxicol 41(2): 111-142. 

154 

 
 
                                                           
For solvents used for cleaning that contained benzene at concentrations of less than 0.1%, the 
amount of benzene absorbed through the skin over a long period was significant, depending on 
exposure time and exposed skin surface areas159.   

Adverse health effects 

Benzene has a harmonised classification under the CLP Regulation160. Benzene is classified for 
carcinogenicity  (Carc  1A161)  and  mutagenicity  (Muta  1B162).  In  the  recently  published  IARC 
monograph163 benzene was classified as carcinogenic to humans (Group 1164). In this report new 
studies published since the last assessment in 2012 were considered. However, the conclusion 
was not changed. 

Major target organs for non-cancer effects of benzene are165:  

  The bone marrow and  

  the haematological system 

Genotoxicity  (chromosomal  damage)  in  the  haematological  system  is  likely  to  precede 
haematotoxicity  and  carcinogenicity.  After  repeated  exposure,  benzene  can  damage  the 
haematopoietic system (e.g. changes in the bone marrow, leukocytopenia, thrombocytopenia, 
aplastic anaemia with pancytopenia). It has also been shown that benzene has toxic effects on 
the  immune  system  by  suppression  of  humoral  and  cellular  immune  responses.  This  is  a 
consequence  of  the  toxic  effects  of  benzene  on  haematopoiesis  in  the  bone  marrow.  At  high 
concentrations, benzene causes depressant effects on the central nervous system. If swallowed, 
pulmonary oedema and haemorrhage can be caused by aspiration166.  

159  KALNAS  and  TEITELBAUM  (2013),  “Dermal  absorption  of  benzene:  implications  for  work  practices  and  regulations”.  Int  J 
Occup Environ Health 6: 114-121 
160 See footnote 146 
161 A category 1A (Carc1A) carcinogen is a substance known to have carcinogenic potential for humans 
162 A category 1B mutagen (Muta1B) is a substance known to induce heritable genetic mutations or to be regarded as if they induce 
heritable mutations in the germ cells of humans. 
163 IARC (2018), “Benzene. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans (Volume 120)”.  
164 Carcinogenic to humans 
165 See footnote 18 
166 See footnote 18 

155 

 
 
 
                                                           
Annex 8 – Process for setting binding OELs and associated 
provisions under the CMD 

Step 1: Social partners consultation 

TFEU  Article  154  requires  a  formal  two-stage  consultation  of  the  social  partners  at  EU  level 
(management and labour) prior to submitting proposals in the social policy field. As regards the 
present  initiative  this  consultation  took  place  in  2017  and  addressed  the  third  and  fourth 
amendments  of  the  Annex  III  of  the  CMD.  annex  2  provides  further  information  on  the 
outcomes of the consultation. 

Step 2:  Priority  setting 

It is not realistic to set an OEL for every hazardous chemical that may be used at the workplace.  
Instead it is appropriate to identify and target priority substances. 

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

  Potential to cause adverse health effects resulting from occupational exposure. 

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

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

  Degree of evidence for adverse effects.  

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

  Estimated number of workers exposed. 

 

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

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

Considering  the  occupational  cancer  burden,  it  is  important  to  note  that  when  identifying  a 
priority  substance,  stakeholders  look  at  the  whole  range  of  potential  negative  health  effects 
(carcinogenic and non-carcinogenic) which could be prevented by establishing an EU level OEL. 
For  example,  concerning  acrylonitrile,  although  an  impact  on  cancer  prevention  is  somewhat 
limited,  it  will  have  a  substantial  impact  on  prevention  of  other  relevant  non-cancer  health 
problems  such  as  nasal  irritation  (preventing  up  to  408  cases)  which  otherwise  would  cause 
sufferings to these workers and compromise their quality of life. As acrylonitrile (and the other 
two substances) falls under CMD, in order to prevent the whole range of health problems, an 
OEL can only be established under this directive. 

156 

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

Step 3:  Scientific evaluation and public consultation 

Article  16  of  the  CMD  states  that  scientific/technical  data  should  be  included  in  the  basis  on 
which OELs are set, but CMD does not determine which scientific body should be the source of 
such data. However, Based on a Service Level Agreement (SLA) signed by DG EMPL and ECHA, 
theRisk  Assessment  Committee  (RAC)  assists  the  Commission  delivering  scientific  evaluations, 
upon request, on the toxicological profiles of each of the selected priority chemical substances 
in relation to their adverse health effects on workers. These scientific evaluations shall, where 
appropriate,  include  proposals  for  Occupational  Exposure  Limit  values  (OELs),  biological  limit 
values/biological guidance values and/or notations.  This task shall be carried out on the basis of 
the  latest  available  scientific  and  technical  data  and  take  into  account  the  specific  context  of 
occupational exposures at the workplace.   

Scientific information from other sources can also be taken into account 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). 

RAC carries out scientific evaluation at EU level based on the methodology agreed withing the 
ECHA/RAC-SCOEL Joint Task Force and as a result publish an Opinion on scientific evaluation of 
occupational exposure limits for the selected priority chemical substances.  

RAC  procedure  for  the  adoption  of  an  Opinion  includes  an  external  consultation  of  relevant 
stakeholders. This ensures scrutiny of the scientifc evidence and methodological approach used 
by RAC and ensures transparency of the process.  

RAC has concluded Opinions  on all the carcinogens analysed in section 6  –  further details are 
provided in annex 1.   

More information on the ECHA methodology used by RAC can be found on the ECHA website: 
https://echa.europa.eu/en/about-us/who-we-are/committee-for-risk-assessment 

Step 4:  Tripartite consultation of Member States and social partners 

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

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

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

157 

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

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

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

The  adopted  ACSH  Opinions  include,  where  necessary,  specific  comments  from  the  interest 
groups  (Government,  Employers  and  Workers)  which  broadly  reflect  the  principal  points 
maintained by each interest  group throughout  discussions of the Working Party on Chemicals 
(WPC).  

The ACSH has adopted opinions for all priority substances foreseen for the fourth amendment 
of  the  CMD167,  proposing  one  or  several  binding  OELs  for  each  of  them  accompanied  by 
transition  periods,  a  skin  notation  for  Benzene  and  Acrylonitrile  and  a  skin  and  respiratory 
sensitisation notation for Nickel compounds as possible approaches for these chemicals.  

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

Step 5:  Impact assessment 

Between 2018 and 2019 an external contractor evaluated, on behalf of the Commission, health, 
socioeconomic  and  environmental  impacts  of  the  proposed  amendments  to  CMD  in  order  to 
perform an impact assessment according to the regulatory procedures in place.  

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

The  options  for  action  proposed  by  the  ACSH  are  established  through  a  thorough  scientific, 
technical and socioeconomic discussion and in general the tripartite agreements reached in the 
Advisory Committee would be put forward in the eventual Commission's proposal. However, in 
line with the Better Regulation guidelines, an IA is conducted before presenting the proposal. In 
the IA the Commission verifies the ACSH opinions on the basis of a dedicated study. 

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

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

167 The links to these ACSH opinions are available at the Annex II 

158 

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

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

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

After completion of these steps the Commission prepares the legislative proposal which will be 
adopted following the ordinary legislative procedure. The adopted Directive will be published in 
the  EU  Official  Journal  and  Member  Stages  will  then  transpose  the  limit  values  and  any 
associated notation into their national legislation by the date set in the Directive. 

The OELs adopted will then ensure a consistent level of minimum protection for all workers in 
the  EU,  while  leaving  the  Member  States  the  option  of  keeping  or  setting  more  favourable 
standards by introducing more stringent OELs.  

Within the CMD there is an obligation for employers to apply the appropiate measures at the 
workplace to ensure that the exposure of workers to these substances do not exceed the OEL. 
The monitoring and of application and enforcement will be undertaken by national authorities, 
in particular the national labour inspectorates. 

159 

 
 
 
Annex 9 – Options discarded at an early stage 

Several  other  options  have  been  discarded  as  they  were  considered  disproportionate  or  less 
effective in reaching the objectives of this initiative. These options are related either to the OELs 
setting, or to the choice of another instrument, or to the support of the SMEs.  

Options related to the way of setting OELs 

A.  Banning the use of the carcinogenic chemical agents  

For most carcinogens even a very low OEL does not completely eliminate the risk of triggering a 
cancer. 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  already  have  replaced  use  of  the  concerned  chemical  agents  with  safer 
alternatives.  

Wherever  substitution  is  a  suitable  alternative  for  use  of  the  chemical  agents  in  question  the 
CMD already requires this, regardless of the existence 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. 

B.  Directly adopting the most stringent national OEL 

For most of the carcinogens some Member States adopted OELs more stringent than considered 
in this impact assessment. It could be argued that such OELs could be made binding across the 
EU based on an assumption that what is achievable in one Member State should be achievable 
in all.  

However, the EU sets minimum standards in this area and OELs need to be seen in the context 
of  the  minimisation  principle.  This  means  that  industries  have  the  obligation  to  minimise 
exposure below existing OELs if that is technically feasible. 

Options related to the choice of another instrument 

C.  Providing industry-specific scientific information without amending CMD   

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;  

160 

 
 

 

such an option would not fit with the overarching legal framework of the CMD, which 
for  general  exposure  management  requirements  to  be  specifically 
provides 
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. 

D.  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. This would require 
much  improved  data  collection  which  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  to  which  they  are  used  varies  significantly168.  This  option  alone  would 
therefore not be effective in ensuring the same level of minimum protection across the EU. 

E. 

Industry self-regulation  

Certain  industry  initiatives  like  voluntary  product  stewardship  programmes  by  companies  and 
sectors, or autonomous social partner agreements, are not legally binding and not applied in all 
sectors or companies concerned.   

Such agreements are very useful tools to improve the situation over time, however, due to the 
fact  that  their  rules  and  obligations  for  members  are  not  always  implemented  and  thus 
enforced  by  national  authorities,  these  initiatives  can  only  be  considered  as  complementary 
tools. 

F.  Regulation under other EU instruments (REACH) 

The  OSH  Directives  and  REACH  are  complementary,  and  clear  synergies  between  REACH  and 
worker protection legislation can be seen – these are set out in more detail in section 4 of this 
report and in annex 10. 

In  the  case  of  the  present  proposal,  setting  binding  OELs  under  the  CMD  is  the  appropriate 
regulatory  instrument.  Among  the  reasons  in  support  of  this  approach  there  is  the  fact  that 
CMD  covers  worker  exposure  to  carcinogenic  agents  released  by  any  work  activity,  whether 
produced  intentionally  or  not,  and  whether  available  on  the  market  or  not,  such  as  process 
generated substances in the workplace.  

As  mentioned  in  section  4,  industrial  processes  are  not  subject  to  the  REACH  restriction  for 
benzene.  Reviewing  the  OEL  for  this  substance  used  in  industrial  processes  is  therefore 
appropriate to improve the protection of workers. 

Protection  of  workers  from  the  exposure  to  nickel  compounds  would  also  be  improved  by 
setting an OEL at the EU level. Indeed, the current REACH restriction concerns the use of nickel 

168  EU-OSHA.“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 

161 

 
 
                                                           
and its compounds in jewellery and articles which are intended to come into contact with the 
skin.  In  addition,  three  EU  Members  States  (France,  Germany  and  Hungary)  have  carried  out 
Regulatory management option analysis (RMOAs) for some nickel compounds. As a result of this 
RMOA  approach,  the  EU  has  prioritised  setting  a  binding  OEL  as  the  most  appropriate  risk 
management measure for nickel compounds.    

As the REACH restriction for acrylonitrile does not concern the industrial uses, the setting of an 
OEL for this substance under the CMD will improve the protection of workers as they are not 
covered by the REACH restriction.   

Furthermore,  CMD  is  intended  to  set  OELs,  which  are  an  important  part  of  the  wider  OSH 
approach to managing chemical risks169. 

G.  Guidance documents 

As  non-regulatory  alternatives,  guidance  documents  or  examples  of  good  practice  could  be 
developed  and  disseminated  in  co-operation  with  the  EU-OSHA  and/or  the  ACSH  and  its 
relevant working party. This could also include the development of awareness raising campaigns 
for  employers  and  workers  alike on  the  prevention of  risks  arising  from  workers'  exposure  to 
categories 1A and 1B carcinogenic and mutagenic substances. However guidance documents by 
itself would not be considered effective enough in reaching the objectives of this initiative. They 
are complementary and provide an added value to setting OELs.  

Option related to the support of the SMEs 

H.  Adapted solutions for SMEs 

SMEs should not be generally exempted from the scope of the initiative as their exclusion would 
mean that a very significant number of European workers would not be covered by health and 
safety  at  work  legislation,  with  a  clear  distortion  and  inequality  in  the  application  of  the  EU 
legislative  framework  and  with  a  risk  of  compromising  the  underlying  social  policy  objectives 
and fundamental rights. 

corresponding OEL in the Annex III, thereby pre-empting the preparatory work of the European 
Commission. Therefore, as DEEE was addressed in the second revision of the CMD, there was no 
need anymore to consider it in the framework of the fourth revision of the CMD.   

169 For a detailed analysis of the differences between CMD and REACH see section 4.2, page 34, of SWD(2016)152/2. 

162 

 
 
 
                                                           
Annex 10 – Consistency and synergies with the REACH 
Regulation170 

The  REACH  Regulation,  adopted  in  2006,  consolidated  and  evolved  several  parts  of  the  EU 
chemicals legislation, including those relating to risk assessment and to the adoption of the risk 
management  measures.  The  REACH  Regulation  established  the  'registration'  of  all  chemicals 
produced or imported above 1 tonne on the EU market and 'authorisation' and 'restriction' as 
risk management measures to control the exposures of chemicals, including substances of very 
high concern (SVHC), at the workplace or for industrial uses. 

A  carcinogenic  chemical  may  appear  complementary  on  both,  CMD  Annex  III  and  the  REACH 
Regulation  Annex XIV  (the  list  of  SVHC  which  can  only  be  placed on  the market  or  used  if  an 
authorisation has been granted for a specific use by the European Commission), as well as on 
the REACH Regulation Annex XVII (restricted substances). 

The OSH Framework Directive – under which CMD is operational – applies without prejudice to 
existing  or  future  national  and  EU  provisions  which  are  more  favourable  to  the  safety  and 
protection  of  the  health  of  workers  at  work.  The  REACH  Regulation  in  turn  applies  without 
prejudice to worker protection legislation, including the CMD. 

Clear  synergies  between  the  REACH  Regulation  and  worker  protection  legislation  exist,  in 
particular the REACH Regulation 'registration' should result in more information being available 
to inform chemicals risks assessment. 

The  REACH  Regulation  'authorisation'  and  'restrictions'  also  establishes,  for  a  given  chemical 
agent,  a  clear  and  renewed  pressure  to  substitute  it  with  safer  alternatives,  and  can  drive 
industry  to  improve  the  risk  management  measures  and  operational  conditions  at  the 
workplace  in  order  to  improve  the  safety  and  the  protection  of  workers.  At  the  same  time 
existing OELs and/or the underlying information used for setting the OEL can be used to derive 
DNELs under the REACH Regulation.171 

An  authorisation  under  the  REACH  Regulation  may  only  be  granted  for  specific  uses  and 
operators  who  have  demonstrated  that  the  risks  are  either  adequately  controlled  (the 
'adequate  control  route') or when the  socio-economic  benefits  outweigh  the  risk arising  from 
the  use  (the  'socio-economic  route')  and  there  are  no  suitable  alternative  substances  or 
technologies. 

Workers exposure is the main exposure scenario today for almost all substances listed in Annex 
XIV as most of these chemicals are used in industrial settings. For some substances restrictions 
in marketing and use are important risk management measures under REACH, to be applied at 
EU level by all companies. 

Applicants  for  authorisation  must  include,  amongst  other  elements,  for  each  of  the  uses 
covered in their application, an assessment of the exposure of workers to the substance(s) and 

170 See footnote 9 
171 ECHA 2012 (updated 2016): Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8. Available at: 
https://echa.europa.eu/guidance-documents/guidance-oninformation-requirements-and-chemical-safety-assessment 

163 

 
                                                           
the  related  risk,  at  the  individual  workplaces  concerned  or  over  a  representative  sample  of 
workplaces.  If the  risk  management  measures  set  out  in  the  application  are  not  judged  to  be 
appropriate and effective by ECHA's Risk Assessment Committee, conditions and/or monitoring 
arrangements  can  be  imposed  in  the  authorisation  decision  to  reduce  exposure  and  risks 
further, including biomonitoring and regular occupational exposure measurements.  

However, some uses of substances are not covered by the authorisation requirement, namely 
intermediates172  and  unintended  process  generated  substances.  Intermediates  as  defined  by 
the REACH Regulation are chemical substances which are manufactured for and consumed in or 
into  another  substance173. 
used  for  chemical  processing 
Occupational  exposure  to  intermediates  may  nevertheless  occur  for  example  during  cleaning, 
maintenance,  etc,  where  residues  may  be  present  and/or  where  process-streams  are 
interrupted and containment may be compromised. 

in  order  to  be  transformed 

The  co-existence  of  a  CMD  OELs  alongside  the  REACH  Regulation  authorisation  will  provide 
several  important  benefits  for  the  practice  of  both  OSH  and  the  REACH  Regulation  worker 
protection provisions: 

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

  For  so-called  non-threshold  carcinogens,  the  OEL-setting  process  provides  a  thorough 
and  robust  process  for  establishing  minimum  standard  exposure  levels  –  ultimately 
passing  through  the  co-legislator  for  adoption  –  based  on  a  science  and  stakeholder 
consultation based process. The overall relationship between the REACH Regulation and 
the OSH Directives (including some references specific to the CMD) has been subject of 
an opinion of the 'REFIT Platform'174 adopted on 27-28 June 2016.175 

In  their  document  the  REFIT  Platform  recognises  that  the  two  sets of  legislation  are  mutually 
reinforcing but points out that the interface between the REACH Regulation and OSH legislation 
is  complex  and  that  further  clarification  is  needed.  Furthermore,  the  ongoing  review  of  the 
REACH Regulation revealed areas where improvements in the interaction of both areas can be 
made. 

The  concerned  Commission  services  are  working  on  providing  clarifications  and  are  together 
developing a common understanding approach on the interface between the REACH Regulation 
and OSH legislation as regards hazardous chemicals at the workplace. 

Statut of the substances under the REACH Regulation 

172  Apart  from  'non-isolated  intermediates'  which,  during  synthesis,  are  not  intentionally  removed  (except  for  sampling)  from  the 
equipment in which the synthesis takes place. 
173 Article 3(15) of REACH. 
174 The European Commission established the 'REFIT Platform' of Member State government and EU stakeholder representatives to 
support the simplification of EU law and the reduction of regulatory burden without detracting from the policy objectives of EU law. 
175  European  Commission 
(2016):  REFIT  Platform  Opinion.  Available  at:  https://ec.europa.eu/info/files/refit-platform-
recommendations-chemicals-ii2a-reach-osh_en 

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Acrylonitrile 

Restriction 

Table 86: Statut of the substances under the REACH Regulation 

Acrylonitrile  use  is  restricted  under  Entry  28176  of  Annex  XVII  under  the  REACH 
Regulation. Substances listed under Entry 28 are not to be placed on the market for 
use  by  the  general  public  ‘when  the  individual  concentration  in  the  substance  or 
mixture is equal to or greater than’ either the ‘relevant specific concentration limit’ 
specified  in  Part  3  of  Annex  VI  to  Regulation  (EC)  No  1272/2008  or  the  ‘relevant 
generic  concentration  limit’,  specified  in  Part  3  of  Annex  I  to  Regulation  (EC)  No 
1272/2008. Suppliers shall ensure before placing on the market that the packaging 
of such substances and mixtures is marked as ‘Restricted to professional users’. 

Authorisation 

Acrylonitrile is not subject to authorisation according to Annex XIV of REACH.  

Nickel compounds 

Restriction 

Annex XVII of REACH entry 27177 restricts the use of nickel and it compounds in 
jewellery (including watches) and articles intended to come into contact with the 
skin. 

Authorisation  Nickel and its compounds are not listed in the Annex XIV of REACH ("Authorisation 

List"), therefore there are no authorised uses for nickel and its compounds. 

Benzene 

Restriction 

The following uses of benzene are restricted in entry 5178 of Annex XVII:   

1. Shall not be used in toys or parts of toys where the concentration of benzene in 
the free state is greater than 5 mg/kg (0,0005%) of the weight of the toy or part of 
toy.  

2. Toys and parts of toys not complying with paragraph 1 shall not be placed on the 
market.  

3. Shall not be placed on the market, or used,   

− as a substance,   

−  as  a  constituent  of  other  substances,  or  in  mixtures,  in  concentrations 
equal to, or greater than 0.1% by weight  

4. However, paragraph 3 shall not apply to:   

a) motor fuels which are covered by Directive 98/70/EC6;   

b) substances and mixtures for use in industrial processes not allowing for 
the  emission  of  benzene  in  quantities  in  excess  of  those  laid  down  in 
existing legislation.   

c) natural gas placed on the market for use by consumers, provided that the 

176 https://echa.europa.eu/documents/10162/caa50aef-640d-43b6-8eb0-6c9c542afa70 
177 https://echa.europa.eu/documents/10162/7851171d-53e9-455a-8bb8-7ca22e89ad87 
178 https://echa.europa.eu/documents/10162/59f436ca-8afa-4adf-b108-27d7bc8a7751 

165 

 
 
 
                                                           
concentration of benzene remains below 0.1% volume/volume’. 

Authorisation 

Benzene is not listed on annex XIV of REACH, thus not subject to authorisation.   

166