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 on the protection of workers from the risk related to exposure to carcinogens or mutagens at work
Date: 2018-04-05
Institutions: Directorate-General for Employment, Social Affairs and Inclusion, European Commission
Subjects: beryllium, cadmium, cancer, carcinogenic substance, chemical compound, health risk, occupational disease, occupational health, safety standard, semi-metal

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 5.4.2018  SWD(2018) 88 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 on the protection of workers from the risk related to  exposure to carcinogens or mutagens at work {COM(2018) 171 final} - {SWD(2018) 87 final}  
 
 
Table of contents 

1. 

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

2.  PROBLEM DEFINITION .......................................................................................... 3 

3.  WHY SHOULD THE EU ACT? .............................................................................. 10 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ..................................................... 12 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? .......................................... 13 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS AND HOW DO 

THEY COMPARE? .................................................................................................. 17 

7.  OVERALL IMPACT OF THE PACKAGE OF RETAINED OPTIONS ................ 40 

8.  HOW  WILL  ACTUAL 

IMPACTS  BE  MONITORED  AND 

EVALUATED? ......................................................................................................... 44 

ANNEXES ........................................................................................................................ 46 

ANNEX 1:   PROCEDURAL INFORMATION 

ANNEX 2:   STAKEHOLDER CONSULTATION  

ANNEX 3:   WHO IS AFFECTED AND HOW? 

ANNEX 4:   ANALYTICAL METHODS 

ANNEX 5:   OELS IN EU MEMBER STATES FOR THE SUBSTANCES SUBJECT 

TO THIS REPORT 

ANNEX 6:   SELECTION PROCEDURE FOR PRIORITY SUBSTANCES 

ANNEX 7:   RELEVANT SECTORS, USES AND ACTIVITIES 

ANNEX 8:   ROUTE(S) OF EXPOSURE, ADVERSE HEALTH EFFECTS 

ANNEX9:  

PROCESS FOR SETTING BINDING OELS AND ASSOCIATED 
PROVISIONS UNDER THE CMD 

ANNEX 10:   CONSISTENCY AND SYNERGIES WITH THE REACH 

REGULATION 

 
 
 
 
 
 
 
Term or acronym 

ACSH 

ANSES 

As 

ASA 

BAuA 

BeST 

BLV 

BGV 

CAD 

CAREX 

CBD 

Cd 

CLP 

CMD 

DALY 

DMA 

DNEL 

ECHA 

EIG 

EP 

ERR 

EU 

EU-OSHA 

FinJem 

GIG 

HSE 

IARC 

ICdA 

ICT 

INRS 

IOM 

LTCR 

mg 

MEGA 

MMA 

MOCA 

Glossary 

Meaning or definition 
Advisory Committee on Safety and Health at Work 

French Agency for Food, Environmental and Occupational Health & Safety 

Arsenic 

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

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin 

Beryllium Science and Technology Association 

Biological Limit Value 

Biological Guidance Value 

Chemical Agents Directive (Directive 98/24/EC) 

CARcinogen EXposure database 

Chronic Beryllium Disease 

Cadmium 

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

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

Disability-Adjusted Life Year 

Dimethylarsinic acid 

Derived No Effect Level 

European Chemicals Agency 

Employers Interest Group 

European Parliament 

Exposure Risk Relationship 

European Union 

European Agency for Safety and Health at Work 

Finnish Job Exposure Matrix 

Governments Interest Group 

Health and Safety Executive 

International Agency for Research on Cancer 

International Cadmium Association  

Information and communication technology 

Institut National de Recherche et Sécurité 

Institute of Occupational Medicine 

Life Time Cancer Risk 

Milligram 

Messdaten zur Exposition gegenüber Gefahrstoffen am Arbeitsplatz 

Monomethylarsonic acid 

4,4'-Methylene-bis(2-chloroaniline)  

 
 
Term or acronym 

Meaning or definition 

MSs 

NACE 

NAIC 

Ni-Cd 

OEL 

OJ 

OSH 

ppm 

RAC 

REACH 

REGEX 

RIVM 

RMMs 

RPA 

SCOEL 

SEAC 

SMEs 

STEL 

SUMER 

SVHC 

SWD 

t 

TFEU 

TWA 

µg 

UN 

UK 

US 

Member States 

Nomenclature des Activités Économiques dans la Communauté Européenne 

North American Industry Classification System 

Nickel-Cadmium 

Occupational Exposure Limit (Value) 

Official Journal 

Occupational Safety and Health 

parts per million 

Risk Assessment Committee of ECHA 

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

Registry of Subjects Occupationally Exposed to Carcinogens 

The  Netherlands  National  Institute  for  Public  Health  and  the  Environment 
(Rijksinstituut voor Volksgezondheid en Milieu) 

Risk Management Measures 

Risk & Policy Analysts Ltd 

Scientific Committee on Occupational Exposure Limits 

Socio- Economic Assessment Committee of ECHA 

Small and Medium Sized Enterprises 

Short Term Exposure Limit 

Surveillance Médicale des Expositions aux Risques Professionnelles 

Substance of Very High Concern 

Staff Working Document 

tonnes 

Treaty on the Functioning of the EU 

Time-Weighted Average 

Microgram 

United Nations 

United Kingdom 

United States 

US-OSHA 

US-Occupational Safety and Health Administration 

WHO 

WIG 

WPC 

WTP 

World Health Organisation 

Workers Interest Group 

Working Party 'Chemicals at the Workplace’ 

Willingness to pay  

 
 
 
1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

In the State of the Union Address 20171 President Juncker emphasized the need to avoid 
social  dumping  in  Europe  by  joining  efforts  and  delivering  on  the  European  Pillar  on 
Social  Rights2.  The  Pillar  -  jointly  proclaimed  by  the  Commission,  the  European 
Parliament and the Council on 17 November 2017 at the Social Summit in Gothenburg - 
identifies  workers'  right  to  healthy,  safe  and  well-adapted  work  environment,  including 
protection from carcinogens, as one of the main principles. Protection of workers' health, 
by  continuously  reducing  occupational  exposures  to  carcinogenic  and  mutagenic 
substances, is a concrete action of the Juncker Commission to deliver on this key priority. 
This has been clearly stated in the Commission Communication on "Safer and Healthier 
Work for All"3. 

Cancer  is  the  main  work-related  health  problem  in  the  EU-28,  causing  almost  as  much 
damage  to  workers'  life  and  health  as  the  two  following  combined  (musculoskeletal 
disorders  and  circulatory  diseases).  Its  negative  impact  is  also  far  greater  than  that  of 
work-related  accidents4.  It  brings  about  suffering  to  workers  and  their  close  ones,  poor 
quality of life, undermined wellbeing and, in the worst case, death. 

Figure 1: Work-related health problems cause the highest DALY in the European Union 

Reducing  exposure  to  carcinogens  and  mutagens  at  the  workplace  by  setting  EU-wide 
occupational exposure limit values (OELs) would effectively contribute to the prevention 
of cancer cases and death, as well as other significant non-cancer health problems caused 
by these substances. Consequently, it increases the length, quality and productivity of the 
working 
to  better  productivity  and 
competitiveness of the EU, and improves the level playing field for businesses. 

lives  of  European  workers,  contributes 

For  this  reason  this  Commission  has  initiated  a  continuous  process  of  updating  the 
Carcinogens and Mutagens Directive (CMD)5 to keep abreast with the new scientific and 
technical developments, and taking 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 

1    State of the Union Address 2017, available at: https://ec.europa.eu/commission/state-union-2017_en 
2  European 

Rights, 
https://ec.europa.eu/commission/priorities/deeper-and-fairer-economic-and-monetary-union/european-
pillar-social-rights_en 

November 

available 

Social 

2017, 

Pillar 

of 

at: 

3      Communication  from  the  Commission  "Safer  and  Healthier  Work  for  All  -  Modernisation  of  the  EU 
final: 
Legislation 

Occupational 
.http://ec.europa.eu/social/main.jsp?langId=en&catId=89&newsId=2709 

Policy"  COM/2017/012 

and  Health 

Safety 

and 

4  EU-OSHA  (2017):  What  are  the  main  work-related  illnesses  and  injuries  resulting  in  death  and  in 

DALY? Available at: https://visualisation.osha.europa.eu/osh-costs 

5  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  

1 

 
 
                                                            
with  the  REACH  Regulation6  is  ensured  in  this  respect.  The  finalised  REFIT  OSH 
evaluation7  as  well  as  the  preliminary  conclusions  of  the  REACH  REFIT  evaluation8 
have underscored and fed into this process. 

Updating and reviewing the CMD has now become a continuous process:  
Two  legislative  amendments  updating  the  CMD,  of  May 20169  and  January 201710, 
addressing  together  20  carcinogens,  have  been  proposed.  The  first  amendment  was 
adopted by the co-legislators end 201711 and on the second the Council adopted a general 
approach on 15 June 2017. The European Parliament's first reading position is expected 
in the first quarter of 2018. 

For  further  amendments  including  the  one  at  hand,  the  Commission  follows  the  same 
process  as  for  the  two  previous  proposals;  it  has  conducted  a two-stage  consultation  of 
the  European  Social  Partners12,13  in  accordance  with  Article  154  of  the  Treaty  on  the 
Functioning of the European Union (TFEU).  

Both workers' and employers' organisations confirmed that the five carcinogens selected 
for this amendment of the CMD are of high relevance for the protection of workers (see 
Annex  2  for  more  information)  and  encouraged  the  Commission  to  continue  the 
preparatory work for the establishment of OELs for those priority carcinogens: 

  Cadmium and its inorganic compounds under the scope of the CMD 
  Beryllium and inorganic beryllium compounds under the scope of the CMD 
  Arsenic acid and its salts, as well as inorganic arsenic compounds under the 

scope of the CMD14 

  Formaldehyde 
  4,4'-Methylene-bis(2-chloroaniline) (MOCA) 

Estimates show that this proposal, when adopted, in longer term would improve working 
conditions for over1 000 000 EU workers and prevent over 22 000 cases of work-related 
ill health15.   

6  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. 

7  Ex-post evaluation of the EU occupational safety and health Directives (REFIT evaluation)SWD(2017) 

10 final, available at: 
http://www.cc.cec/sg/vista/home?documentDetails&DocRef=SWD/2017/10&ComCat=SPINE 

8  REACH REFIT evaluation (REACH Review 2017), available at: 
https://ec.europa.eu/growth/sectors/chemicals/reach/review_en 

9  COM(2016) 248 final of 13 May 2016, Proposal for a Directive of the European Parliament and of the 
Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure 
to carcinogens or mutagens at work 

10  COM(2017)11 final of  10 January 2017, 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. 

11  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: http://eur-lex.europa.eu/eli/dir/2017/2398/oj 

12  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. 

13  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. 

14  The first three carcinogens listed above are substance groups which comprise a large number of priority 
compounds  (Cadmium:  11,  Beryllium:  9  and  Arsenic:  26  compounds,  respectively).  The  criteria  for 
prioritisation and selection procedure for the retained substances or groups are presented in Annex 6. 

2 

 
                                                            
 
Given  the  level  of  scientific  and  technical  knowledge  required  to  identify  measures, 
which  at  the  same  time  adequately  protect  workers  and  are  practically  feasible  for 
industries, the European Commission bases proposals in this area on opinions developed 
by  the  tripartite  Advisory  Committee  on  Safety  and  Health  at  Work  (ACSH).  The 
opinions of ACSH take into account scientific basis, which is indispensable to underpin 
OSH  legislation.  With  a  view  to  mainstream  scientific  advice  and  in  line  with  the 
Commission Communication on "Safer and Healthier Work for All", the Commission for 
this  proposal  sought  advice  from  both,  the  Scientific  Committee  on  Occupational 
Exposure Limits (SCOEL) and the Risk Assessment Committee (RAC) of the European 
Chemicals Agency (ECHA). 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 
framework  of  the  tri-partite  ACSH  strongly  anticipate  the  legal  clarity  and  increased 
protection which would be the result of lower OELs on these substances. 

The  analysis  presented  in  this  document  should  be  read  in  conjunction  with  the  earlier 
impact  assessment  (IA)16  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 five additional carcinogens.  

2.  PROBLEM DEFINITION 

2.1.  What is/are the problems? 

Carcinogenic  and  mutagenic  substances  lead  not  only  to  cancers,  but  to  also  other 
important  health  problems.  For  example,  exposure  to  beryllium,  in  addition  to  lung 
cancer, also causes incurable chronic beryllium disease. If effective measures are put in 
place to prevent high exposures of the five substances under consideration, their positive 
impact  would  be  much  broader  than  cancer  prevention  alone  –  in  longer  term  the 
proposal would improve working conditions for over 1 000 000 EU workers and protect 
over 22 000 workers from significant health problems. 

Furthermore, ineffective prevention of the exposure to carcinogens would have negative 
consequences  for  business  such  as  higher  costs  and  reduced  productivity  due  to 
absenteeism,  lost  expertise  and  distorted  competition;  and  for  Member  States  due  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: 

15   RPA (2018) draft final report.Third study on collecting most recent information for a certain number of 
substances  with  the  view  to  analyse  the  health,  socio-economic  and  environmental  impacts  in 
connection with possible amendments of Directive 2004/37/EC. 

16  Commission Staff Working Document, Impact Assessment, accompanying the proposal for a Directive 
of  the  European  Parliament  and  the  Council  amending  Directive  2004/37/EC  on  the  protection  of 
workers  from  the  risks  related  to  carcinogens  or  mutagens  at  work  (SWD(2016)152/2),  available  at: 
https://ec.europa.eu/social/BlobServlet?docId=16877&langId=en 

3 

 
 
                                                                                                                                                                                 
Figure 2: Problem tree 

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 numbers17,18,19 of workers exposed to 
the  substances  subject  to  this  initiative  and  a  short  explanatory  summary  for  each 
substance.  More  detailed  information,  e.g.  on  estimated  ranges,  breakdown  of  relevant 
sectors etc., is provided in Annex 7. 

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. 

17  Kauppinen,  T.,  Toikkanen,  J.,  Pedersen,  D.,  Young,  R.,  Ahrens,  W.,  Boffetta,  P.,  Hansen,  J., 
Kromhout,  H.,  MaquedaBlasco,  J.,  Mirabelli,  D.,  de  la  Orden-Rivera,  V.,  Pannett,  B.,  Plato,  N., 
Savela,  A.,  Vincent,  R.  &Kogevinas,  M.  (2000):  Occupational  exposure  to  carcinogens  in  the 
European Union. Occ Environ Med 57, pp. 10–18. 
IOM, Institute of Occupational Medicine (2011): Health, socio-economic and environmental aspects of 
possible  amendments  to  the  EU  Directive  on  the  protection  of  workers  from  the  risks  related  to 
exposure  to  carcinogens  and  mutagens  at  work.  IOM  Research  Project:  P937/99,  May  2011,  IOM, 
Institute of Occupational Medicine, Edinburgh, UK. 

18 

19  See footnote 15 

4 

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

Carcinogen 

Exposed workforce 
(number of workers) 

Typical exposure 
levels 

Major occupational 
exposure route  

Cadmium and  
its inorganic 
compounds  

10 000 
Range of 2900 – 300 000 
between different 
estimates 

5 µg/m³ to 50µg/m³;  
with extreme values up 
to 400 µg/m³ 

0.19 µg/m3 –  
2.78 µg/m3 

0.1 µg/m3 –   
45 µg/m3 

with extreme values up 
to 312 µg/m3 
in the domestic glass 
sector 
0.1 mg/m3 –  
3 mg/m3 
Higher values 
estimated for the 
hospitals, embalmers, 
veterinary activities 
(HEV sectors) 
0.1 µg/m3 –  
5 µg/m3, with extreme 
values up to 15 µg/m3 

Beryllium and 
inorganic 
beryllium 
compounds  

Arsenic acid and 
its salts, as well 
as inorganic 
arsenic 
compounds 

Formaldehyde 

54 000 
Range of 14 000 – 
74 000 (depending on 
which of the three 
datasets chosen 
Construction sector: 
7 000 – 41 000 
7 900 –15 300 
In addition: 
18 000-102 000 
potentially exposed 
below the lowest 
assessed OELs 

990 000 
Range of 990 000 – 
2 200 000 between 
different estimates 

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

350 
1 200 workers may 
potentially be indirectly 
exposed 

Total workforce 
assessed:  

~ 1 070 000 

Based on RPA (2018) 

Inhalation of cadmium-
containing dusts and fumes. 
Incidental ingestion of dust 
at work from contaminated 
hands, cigarettes or food. 
Inhalation of beryllium-
containing dusts and fumes.  
Dermal exposure is relevant 
for non-carcinogenic ill-
health effects. 

Inhalation of arsenic 
containing particulates. 
Ingestion (skin-to-mouth) 
exposure may be significant 
in specific situations. 

Inhalation as the main route.  
Ingestion and absorption 
through the skin not 
negligible. 

Absorption through the skin 
after contact with 
contaminated sites. 
Inhalation and ingestion 
represent minor sources. 

Cadmium and its inorganic compounds under the scope of the CMD 

The  data  collected  for  this  impact  assessment  estimates  a  number  of  10 000 workers 
currently  exposed  to  cadmium  and  its  inorganic  compounds.  However,  only  limited 
extrapolation from the responses received to  some of the sectors has been  possible and 
some indications of exposure could not be confirmed.  

Occupations in which the highest potential exposures occur include cadmium production 
and  refining,  nickel-cadmium  (Ni-Cd)  battery  manufacture,  cadmium  pigment 
manufacture  and  formulation,  cadmium  alloy  production,  mechanical  plating,  zinc  and 
copper smelting, mining of non-ferrous metal ores, brazing with a silver-cadmium-silver 
alloy  solder,  and  polyvinylchloride  compounding.  Recycling  of  scrap  metal  and  Ni-Cd 
batteries may also involve some exposure. 

5 

 
 
 
 
Beryllium and inorganic beryllium compounds under the scope of the CMD 

Ten industrial sectors such as foundries, glass and laboratories were identified in which 
workers  are  at  risk  of  exposure  to  beryllium.  RPA  (2018)  study20  used  two  compounds 
for this assessment, beryllium and beryllium oxide. Copper, aluminium, magnesium and 
nickel are widely alloyed with beryllium. These are a cause of worker exposure and are 
included  in  the  assessment.  Approximately  80%  of  all  beryllium  in  the  EU  is  used  in 
copper beryllium alloys.  

The  study  concludes  that  further  research  and,  in  particular,  survey  data  is  required  to 
establish  whether  there  is  an  issue,  and  if  yes  -  to  what  extent,  with  beryllium  in 
construction. 

Arsenic acid and its salts, as well as inorganic arsenic compounds under the scope of 
the CMD 

The considered exposure data distinguishes between two groups: 

  Workers  for  which  available  data  shows  that  they  are  exposed  at  higher  levels  as 
demonstrated by measurements, modelling or from comparison to similar processes.  

  Other workers who may potentially be occupationally exposed. The latter group either 
works in sectors and with processes where arsenic may be present in raw materials at 
considered relatively low levels, or they work in high-exposure sectors (as the copper 
sector), but likely are not routinely working with the high-exposure processes covered 
by the monitoring of workplace concentrations.  

Exposure to arsenic  compounds occurs,  for example, in  copper and zinc production, as 
well as in the glass, electronics and chemical sectors. 

Formaldehyde 

In addition to formaldehyde manufacturing, it is used in a wide variety of products such 
as adhesives and sealants, coating products, polymers, biocides and laboratory chemicals; 
activities such as building and construction work; and in the manufacturing of leather and 
fur, pulp, paper and paper products, textile and wood and wood products.  

Formaldehyde  is  also  used  for  tissue  preservation  in  embalming  fluids  and  as  a 
disinfectant in pathology departments and autopsy rooms, usually in the form of formalin 
(i.e. mixture of formaldehyde, water, and methyl alcohol). 

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

After  the  sunset  date  of  22  November  2017,  as  set  by  Annex  XIV  to  REACH,  MOCA 
can only be used by the downstream users in the supply chain of the only applicant for 
authorisation. However, the authorisation has not yet been granted. 

Exposed  workers  work  in  the  plastics  sector,  where  MOCA  is  used  for  moulding  of 
polyurethane elastomer parts at 89 sites across the EU.  

Exposure  to  the  carcinogens  addressed  in  this  impact  assessment  leads  to  significant 
health consequences for workers. 

The table below shows the current and future burden of cancer and other health effects 
related to the occupational exposure to the five substances under consideration. Given the 
long latency period of the concerned illnesses, the future health burden is estimated over 
a 60 year period. 

20    See footnote 15 

6 

 
                                                            
However,  the  disease  burden  on  workers  is  likely  to  be  underestimated  due  to  several 
limitations of the data/calculations. 

First, the study quantified burden of only those cancers and other adverse health effects 
which  are  known  to  be  caused  by  the  lowest  exposures  (so-called  most  sensitive 
endpoints).  However,  workers  may  develop  additional  types  of  cancer  and  diseases  at 
higher  exposure  levels  that  have  not  been  quantified  in  the  study  (see  table  2  below). 
When establishing an OEL at a certain level to prevent the most sensitive endpoints, the 
other diseases will be prevented as well. 

Second, the estimates relate only to sectors where exposure currently exists and therefore 
do  not  represent  the  total  burden  of  possible  past  exposure.  More  information  on 
limitations is given in chapter 6. 

Table 2: Current and future disease burden related to occupational exposure to carcinogens 

(number of cases) 

Carcinogen 

Health effects caused 

Current* 
disease burden 
(quantified) 

Future** 
disease burden 
(quantified) 

Cadmium and its 
inorganic 
compounds  

Lung cancer (quantified), bladder, kidney 
and prostatic cancer (not quantified) 

Proteinurea (quantified), osteoporosis and 
respiratory effects (not quantified) 

11 

500 

6 

280 

3 807 

4 602  

Beryllium and 
inorganic beryllium 
compounds  

Arsenic acid and its 
salts, as well as 
inorganic arsenic 
compounds  

Chronic beryllium disease (quantified), 
allergy or asthma symptoms, beryllium 
respiratory sensitisation, skin sensitisation, 
cardiovascular, renal, hepatic and 
haematological effects (not quantified) 

Lung cancer (quantified) cancer in the skin, 
liver, lungs, bladder and kidney (not 
quantified) 

Peripheral neuropathy (quantified),   
cardiovascular effects and immunotoxicity, 
skin changes and blackfoot disease (not 
quantified) 

17 

905 

Formaldehyde 

Nasopharyngeal cancer (quantified), 
leukaemia, tumour induction (not quantified) 

330 

20 

574 

7 

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

TOTAL 

Sensory irritation (quantified), potential 
cancer precursor effects (not quantified) 

19 200 

19 200 

Lung cancer, bladder cancer (quantified) 

0 

0 

24 770 

24 689 

* The current disease burden is estimated over the past 40 years 
** The future health burden is estimated over a 60 year period 

Based on RPA (2018) 

7 

 
 
 
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. The fact that OELs are 
established does not affect the underpinning obligations of the employer to comply with 
other obligations, including to reduce the exposure of his/her workers to carcinogenic and 
mutagenic substances to as low a level as is technically possible (minimised exposure).  

The existence of OELs provides clarity and 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 his/her risk management measures 
should aim to comply with the obligation to reduce the exposure to as low a level as is 
technically  possible.  They  also  support  enforcement  authorities  in  controlling  that 
employers  are  putting in  place  the  relevant  risk management  measures,  including  those 
that could contribute to 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,  for  none  of  which  an  EU  OEL 
exists,  the  scientific  advice  has  been  provided  by  SCOEL  (cadmium,  beryllium, 
formaldehyde)  and  RAC  (arsenic  and  MOCA).  The  tripartite  ACSH  has  adopted 
opinions for all five. 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. 

2.2.3.  Diverging  national  OELs  create  different  competing  conditions  and 

protection levels across the EU 

While no EU OELs have been established for the five carcinogens considered under this 
initiative,  there  is  a  diverse  situation  as  for  legal  protection  at  national  level.  For  each 
substance there is a range of national OELs and a number of Member States that have not 
set OELs. The table below summarises the divergences: 

Table 3:  National OELs in EU Member States 

Carcinogen 

Lowest (strictest) 
national OEL 
(mg/m3) 

Cadmium and 
inorganic compounds 

0.002 
BE, PL, PT, ES, SE  

Highest (least 
strict) national 
OEL 
(mg/m3) 
0.05  
FR, LT  

Member States with no 
OEL 

3  
IT, LU, MT 

8 

 
 
Beryllium and 
inorganic beryllium 
compounds 
Arsenic acid and its 
salts, as well as 
inorganic arsenic 
compounds 
Formaldehyde 

0.00005 
PT (inhalable 
fraction) 
0.01  
CY, IE, LV, PT, 
RO, ES, SE 

0.05  
AT, EL, SK, SI 

4 
IT, LU, MT, NL 

0.2  
FR (As2O3) 

3 
IT, LU, MT 

0.15  
NL 
0.005 
IE, UK 

4,4'-Methylene-bis(2-
chloroaniline) 
(MOCA) 
* In Sweden working with this substance requires permission from the Swedish environmental authority 
before it can be used. 
Based on RPA (2018) 

3 
CY 
0.22  
FR, EL, RO 

5  
BE, IT, LU, MT, ES 
12  
BG, CY, CZ, EE, DE, HU, 
IT, LV, LT, LU, MT, SE* 

Diverging national OELs not only lead to different workers protection levels across the 
EU  but  also  distort  competition.  For  example,  PT  firms  need  to  comply  with  an  OEL 
1000  times  smaller  (i.e.  stricter)  than  firms  in  AT,  EL,  SK  and,  therefore,  their 
investments  on  protective  measures/equipment  would  be  higher.  These  national 
differences may lead to complications for businesses operating in different EU Member 
States. Annex 5 presents 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 are 

not fully exploited 

State-of-the-art  industrial  production  processes  allowing  for  the  further  reduction  of 
occupational exposure to carcinogenic, mutagenic and other hazardous substances in the 
workplace  exist  but  their  adoption  is  not  generalised.  One  possible  reason  is  that 
decisions  of  business  are  often  influenced  by  short-term  cost  assumptions  rather  than 
long-term benefits. 

For  example,  exposure  to  cadmium  and  MOCA  could  be  further  reduced  by  a  higher 
degree  of  automation,  e.g.  in  plating  and  coating  processes  and  in  the  production  of 
nickel-cadmium batteries21, and regarding exposure to MOCA, also in the manufacture of 
rubber products22.  

Risk management measures, such as improved local exhaust ventilation systems, would 
reduce exposure of workers to formaldehyde e.g. during the wood panel production23, to 
arsenic acid and its salts in manufacturing of copper foils24 and in recycling facilities, and 

21  SCOEL (2017): Recommendation from the Scientific Committee on Occupational Exposure Limits for 

Cadmium and its inorganic compounds. SCOEL/OPIN/336. 
Available at: https://circabc.europa.eu/sd/a/13cad802-1f3c-40c0-bce4-6838cf5fc4ff/OPIN-
336%20Cadmium%20and%20its%20inorganic%20compounds.pdf 

22  RAC (2017): Opinion on 4,4’-methylene-bis-[2-chloroaniline] (MOCA) of 29 May 2017. Available at: 

https://circabc.europa.eu/sd/a/ccd6160e-bf6b-45b0-8210-
fa9b928572c9/05.%20Final_opinion%20of%20RAC_MOCA-29-5-2018.pdf 

23  ECHA  (2017):  Investigation  Report:  Formaldehyde  and  Formaldehyde  releasers,  reply  by 

FORMACARE to Call for evidence, p. 67. 
on  Arsenic 

(2017):  Opinion 

24  RAC 

acid 
https://echa.europa.eu/documents/10162/13641/opinion_arsenic_en.pdf/dd3eb795-108e-5d3a-6847-
dddcc021a9dc 

salts.  Available 

inorganic 

and 

its 

at: 

9 

 
 
                                                            
to beryllium in manufacturing of alloys and ceramics25, to levels which would be more 
protective of workers health. 

2.3.  How will the problem evolve? 

In  the  absence  of  EU  action,  the  consequences  described  above  will  continue. 
Estimations  on  the  numbers  of  deaths  and  health  costs  in  case  no  action  is  taken 
regarding  the  carcinogens  covered  in  this  report  are,  where  available,  described  in  the 
baseline scenario26 in section 6. 

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.  Further  demographic 
changes  increase  the  life  expectancy  of  workers  exposed  and,  therefore,  the  chances  to 
develop the illnesses mentioned in table 2. 

Member  States  usually  do  not  inform  the  Commission  on  their  intentions  to  revise 
existing  or  determine  new  OELs  in  their  national  legislation;  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. 

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 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. 

25  SCOEL (2017): Recommendation from the Scientific Committee on Occupational Exposure Limits for 
at: 

SCOEL/REC/175.  Available 

Beryllium 
beryllium 
https://circabc.europa.eu/sd/a/33c8921a-1dbe-4410-909c-2d4c63d8fb1d/REC-
175%20Beryllium%20and%20compounds.pdf 

compounds. 

inorganic 

and 

26  The  estimates  presented  only  relate  to  the  sectors  where  exposure  to  the  carcinogens  specified 
currently occurs and do not represent the total burden of past occupational exposure. The total burden 
from all past occupational exposure to these carcinogens would require consideration of sectors where 
occupational exposure no longer takes place and which are not relevant to the problem definition for 
this IA. 

10 

 
                                                            
Addressing  the  social  dimension  of  the  European  Union  by  putting  forward  a  proposal 
for  a  Directive  on  the  protection  of  workers  from  the  risks  related  to  exposure  to 
carcinogens  or  mutagens  is  included  in  the  Joint  Declaration  on  the  EU's  legislative 
priorities for 2018-201927. 

The  2016-2019  "Roadmap  on  carcinogens"  convenant  initiated  by  the  Dutch  and 
Austrian  governments  as  well  as  the  European  social  partners28  supports  and 
accompanies the process of regular CMD updates. 

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  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.  

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 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. 
Concerning formaldehyde, the employers' and workers' representatives29 in 2016 signed a 
common  letter  addressed  to  the  Commission30  requesting  to  include  it  already  in  the 
second amendment to the CMD. 

Ensuring the same minimum level of protection across the EU 

In case of all carcinogenic chemical agents where OELs are proposed in this initiative at 
least 15 Member States have not yet established legally enforceable OELs for at least one 
of  the  substances.  For  example,  12  Member  States  have  set  no  limits  for  MOCA  –  the 
same is true for 5 Member States in the case of formaldehyde. 

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. 

27  The  Parliament,  the  Council  and  the  Commission.Joint  Declaration  on  the  EU's  legislative  priorities 
for  2018-19,  https://ec.europa.eu/commission/publications/joint-declaration-eus-legislative-priorities-
2018_en 

28  https://roadmaponcarcinogens.eu/about/the-roadmap/ 
29  Formacare, the CEFIC sector group for formaldehyde, the European Panel Federation, the European 
Trade Union Confederation, the European Automobile Manufacturers’ Association, the European Tyre 
and Rubber Manufacturers’ Association and the European Phenolic Resins Association 

30  Letter  of 15 July 2016  to  the  Commission.Request  to  include  Formaldehyde  in  the  Annex  III of  the 

Carcinogen and Mutagen Directive 2004/37/EC  

11 

 
                                                            
Contribution to a levelplaying field 

Employers' orgnisations stressed in their response to the social partner consultation that 
setting EU OELs helps to provide a levelplaying field for industry. Setting EU OELs will 
not  completely  eliminate  the  differences  between  Member  States,  as  they  retain  the 
possibility  to  adopt  more  protective  measures.  However,  it  will  limit  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. The examples of the 
currently existing EU OELs (e.g. for benzene) show that a majority of Member States in 
practice adopt these values directly. 

Assuming burdens at EU level related to derivation of limit values 

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

Given  the  limited  resources  for  OSH  at  national  level,  this  could  release  funds  to  be 
redirected into other OSH priorities. 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

4.1.  General objectives 

This initiative implements principle 10 of the European Pillar of Social Rights ("Healthy, 
safe  and  well-adapted  work  environment")  directly  contributing  to  a  high  level  of 
workers'  health  and  safety  by  eventually  reducing  the  exposure  to  carcinogens  and 
mutagens at the workplace. 

Modernising the legal framework setting updated OELs on exposure to carcinogens was 
also identified as the key priority in the OSH field by the Commission Communication 
'Safer and Healthier Work for All' of 10 January 2017. 

4.2. 

Specific objectives 

The specific objectives are: 

 

 

 

To  reduce  occupational  exposure  to  carcinogens  and  mutagens  in  the  European 
Union; 
To increase the effectiveness of the EU framework by updating it on the basis of 
scientific expertise; 
To  achieve  a  more  balanced  protection  of  workers  across  the  EU  against 
carcinogens  while  ensuring  more  clarity  and  level  playing  field  for  economic 
operators. 

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. 
Ensuring  a  safe  and  healthy  work  environment  is  a  strategic  goal  for  the  European 
Commission as mentioned in the Communication above. 

12 

 
REACH Regulation 
The REACH Regulation31, adopted in 2006, consolidated and developed several parts of 
the  EU  chemicals  legislation  –  principally  those  relating  to  risk  assessment  and  the 
adoption  of  the  risk  management  measures.  The  REACH  Regulation  established  the 
'registration' of all chemicals above 1 tonne produced or imported in 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.  

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

Restrictions  of  the  presence  of  carcinogens,  mutagens  and  reprotoxic  substances  in 
mixtures and in articles and their use in industrial processes, established under REACH, 
apply  for  two  of  the  substances  (arsenic  compounds,  cadmium  and  its  inorganic 
compounds),  subject  of  this  legislative  proposal,  and  two  of  these  substances  (arsenic 
acid and its salts and MOCA can only be used after an authorisation has been granted by 
the European Commission. 

Furthermore,  cadmium  and  five  other  cadmium  compounds  have  been  identified  as 
SVHC  for  possible  inclusion  in  Annex  XIV  to  REACH,  the  Authorisation  list.    A 
detailed  description and the status  of the five substances under REACH is  presented in 
Annex 10.  

For  the  preparation  of this  impact  assessment  and  for  the  development  of  the  scientific 
opinions  on  the  proposed  limit  values,  data  from  the  'registration'  dossiers  prepared  by 
manufacturers  and  importers,  as  well  as  data  that  became  available  to  ECHA's  Risk 
Assessment  Committee  (RAC)  and  to  the  Socio-Economic  Assessment  Committee 
(SEAC)  during  the  development  of  opinions  for  the  Commission  to  decide  on 
authorisations for certain uses or in the restriction process under REACH have been used. 

This  is  a  direct  result  of  the  REACH  REFIT  exercise  focussing  on  streamlining  the 
process of generating scientific advice. 

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 is 
set out here. A more detailed description is provided for in Annex 9. 

31  See footnote 6 

13 

 
 
 
                                                            
Figure 3: Simplified workflow of preparation for EU OEL setting under CMD  

The selection of the specific five carcinogens / groups of carcinogens considered in this 
impact  assessment  was  based  on  a  consultative  approach,  including  opinions  issued  by 
ACSH and 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 five substances are of high relevance for 
the  protection  of  workers.  Commission's  intention  to  prepare  for  the  establishment  of 
OELs  for  those  priority  carcinogens  was  confirmed  and  encouraged  by  all  the 
stakeholders.  

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  formaldehyde  although  an  impact  on  cancer 
prevention  is  somewhat  limited,  it  will  have  a  major  impact  on  prevention  of  other 
relevant non-cancer health problems such as sensory irritation (preventing around 19 200 
cases)  which  otherwise  would  cause  sufferings  to  these  workers  and  compromise  their 
quality  of  life.  As  formaldehyde  (and  the  other  four  substances)  falls  under  CMD,  in 
order  to  prevent  the  whole  range  of  health  problems,  an  OEL  can  only  be  established 
under this directive. 

5.2. Retained options for establishing binding OELs under the CMD  

The reference limit values per substances, for which explicit calculations have been made 
by RPA (2018), are presented below.  

In addition to the baseline scenario, OELs have been considered at the level proposed by 
the  ACSH  and  at  one  or  two  additional  reference  points  (e.g.  the  strictest  limit  value 
observed  among  Member  States).  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 

14 

 
 
 
industries it might be difficult to comply with strict OELs due to their specific production 
processes. Member States with the strictest OELs might not host these 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.  These  considerations  will  be  taken  into  account  in  the  analysis 
substance by substance. 

Table 4: Options matrix of OELs (inhalable) 

Carcinogen 

Cadmium and its 
inorganic compounds 

Option 1 
Baseline 

no EU OEL 

1 µg/m3 

(ACSH) 

Beryllium and inorganic 
beryllium compounds  

no EU OEL 

0.1 μg/m3 

Other options 

4 µg/m3 

10 µg/m3 

(ACSH transition 
value) 
0.2 μg/m3 

(ACSH) 

25µg/m3 

0.6 μg/m3 

(ACSH transition 
value) 
50µg/m3 

Arsenic acid and its salts, 
inorganic arsenic 
compounds 

Formaldehyde 

no EU OEL 

no EU OEL 

10 µg/m3 

(ACSH) 
0.15 mg/m3 

0.37 mg/m3 

0.6 mg/m3 

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

no EU OEL 

5 µg/m3 

(ACSH) 

10 µg/m3 

(ACSH) 

20 µg/m3 

5.3. 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. 

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.  

15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
B.  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; 

  such an option would not fit with the overarching legal framework of the CMD, 
which provides for general exposure management requirements to be specifically 
supplemented by EU-wide minimum standard OELs; 
in some cases, extensive industry- and chemical agent- specific information and 
guidance  already  exists  and  should  be  taken  into  account  by  employers  during 
risk assessments – but this has not demonstrably addressed harmful exposures at 
EU level. 

 

C.  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  vary 
significantly32.  This  option  alone  would  therefore  not  be  effective  in  ensuring  the  same 
level of minimum protection across the EU. 

D.  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. 

E.  Regulation under other EU instruments (REACH) 

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

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 4.3 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 

32  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 

16 

 
                                                            
activity, whether produced intentionally  or  not, and whether available on the market or 
not,  such  as  process  generated  substances  in  the  workplace.  Furthermore,  CMD  is 
intended  to  set  OELs,  which  are  an  important  part  of  the  wider  OSH  approach  to 
managing chemical risks33. 

F. Directly adopting the most stringent national OEL 

For  most  of  the  carcinogens  some  Member  States  adopted  OELs  more  stringent  than 
considered  in  this  proposal.  It  could  be  argued  that  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. 

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.  

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. 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS AND HOW DO THEY COMPARE? 

6.1. Assessed options and how they compare 

This  chapter  provides  an  analysis  of  options  per  chemical  agent,  indicating  first  the 
baseline  scenario,  followed  by  a  multi-criteria  analysis  of  likely  impacts  and  an 
assessment  of  the  preferred  option  compared  to  the  baseline.  Finally,  a  summary 
assessment of the retained options is presented. 

Different  policy  options  presented  in  the  options  matrix  in  chapter  5.2  have  been 
compared  based  on  the  methodology  outlined  in  detail  in  Annex  4.  Other  options  than 
those  supported  by  the  ACSH  in  its  opinions,  such  as  the  most  stringent  OEL,  are 
presented  as  reference  points  for  the  assessment  of  the  ACSH  options,  to  establish 
whether these are at reasonable levels and, therefore appropriate, to follow. The ACSH as 
a  tripartite  committee  is  an important  body to  establish  consensus  and  to  effectuate  the 
preferences of governments, workers and employers. This consensus, as a result, ensures 
the effectiveness and enforcement of new OELs to be established. An OEL that is backed 

33  For  a  detailed  analysis  of  the  differences  between  CMD  and  REACH  see  section  4.2,  page  34,  of 

SWD(2016)152/2. 

17 

 
 
                                                            
by governments, employers as well as workers has secured the acceptance by the three 
groups and therefore will be easier to implement and to enforce. 

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  takes  into  account  how  the  problem  would  evolve, 
considering  all  relevant  societal,  economic  and  technical  developments  that  would 
probably occur in the following decades. It includes an assessment of how the situation is 
likely  to  change  in  terms  of  the  number  of  people  exposed,  exposure  concentrations, 
mortality,  investment  in  Risk  Management  Measures  (RMM),  forthcoming  changes  in 
national  OELs  or  protective  regulation,  self-regulatory  initiatives,  development  of  new 
technologies/growing use of substitutes, as well as any other relevant factors. 

Given  the  complementarity  between  the  regulation  under  REACH  and  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. 

Analytical methods and challenges 

For a given reduction in exposure levels, the expected decrease in the incidence of cancer 
cases and ill health is estimated over a given timeframe attributable to the carcinogen in 
question. The data in this section have been modelled over a period of 60 years using a 
static  discount  rate34.  The  health  benefits  of  avoided  cancer  cases  and  deaths  are 
expressed in monetary terms by applying standard evaluation methods35, in line with the 
Better Regulation Toolbox guidance. 

The  cost  assessment  is  largely  based  on  consultations  with  companies  in  the  specific 
sectors.  The  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  RMM36 
implementation  which  is  determined  by  suitability,  effectiveness,  and  cost.  The  Better 
Regulation Toolbox guidance was followed for the cost calculations.  

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).  Concerning 
environmental impacts, it can be expected that, unless an OEL were to force companies 
to substitute the carcinogen for another substance or to discontinue production in the EU, 
such impacts would be minimal. 

34  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. 

35  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.  

36   The 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). 

18 

 
                                                            
Transposition and enforcement costs for the public sector for all substances are expected 
to be limited, taking into account that the transposition can be done for more substances 
at the same time.  

There are, however, significant challenges related to the presented analysis.  First of all, 
the disease burden on workers is likely to be underestimated due to several limitations of 
the study.  

When  considering  the  disease  burden,  only  the  most  sensitive  cancer  endpoint  and  the 
most sensitive other adverse health effects 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 / 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. 

Furthermore,  regarding  occupational  cancer,  the  available  epidemiologic  evidence  is 
scarce  and  not  always  sufficiently  robust,  inevitably  affecting  the  reliability  of  the 
derived estimates  for the number of  cancer registrations and deaths. 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, the health benefits presented in this report are likely to be underestimated. 

The  60  year-time  frame  of  the  assessment  poses  also  a  challenge  of  anticipating  future 
industrial developments, technological progress, changes in work organisation, etc. It is 
difficult  to  predict  future  trends  in  the  use  of  the  substances  under  consideration  and 
therefore  in  occupational  exposures,  and  how  these  trends  will  impact  the  baseline. 
Similarly, the assessment of the impact on international competitiveness and innovation 
could only be based on consultations and the model assumptions of RPA (2018), but not 
substantiated with hard evidence.  

Finally, data  on the number of workers exposed is  generally scarce and unreliable, and 
data on the current exposure levels across EU Member States is not always available.  

Therefore,  the  baseline  shows  more  modest  figures  than  other  recent  studies37  that 
estimated past burdens of disease. 

Further methodological information is to be found in Annex 4. 

Assessment and comparison of options 

Regarding  health  considerations,  health  impacts  could  not  be  fully  quantified  and  all 
methods using stated preference show uncertain components (e.g. the income and wealth 
of a person). Thus, a number of other qualitative considerations were taken into account 
on top of the quantitative calculations. Such considerations include the limitations of the 
data,  and  the  uncertainty  of  health  effects  and  scarce  epidemiological  evidence,  as 
explained above. Moreover, the different timeframes for costs and benefits can also skew 
a  purely  quantified  calculation.  Often,  significant  parts  of  costs  occur  as  capital 
expenditures in the years following the OEL setting, but health benefits, considering the 
long latency periods for cancer, can occur up to 50 years later. The rather high discount 
rate of 4% set by the Better Regulation guidelines thus reduces net present value of the 
benefits more importantly than that of the costs.  

37  Most notably: RPA and FOBIG (2017): The Cost of Occupational Cancer in the EU-28. Final Report 

prepared for European Trade Union Institute (ETUI). 

19 

 
 
                                                            
This impact assessment aims to balance health considerations against economic impacts, 
by  proposing  OELs  that  are  still  economically  feasible  while  protecting  a  maximum 
number of workers.  

The study accompanying the impact assessment assessed the different 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. 

Concluding, the proposal aims to take a balanced approach and to prevent industries from 
closures or sever disadvantages in particular Member States due to e.g. adopting the most 
stringent  OELs.  Furthermore,  the  CMD  lays  down  the  minimum  requirements  and 
Member States are free to introduce more stringent provisions. 

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. 

6.1.1.  Cadmium and its inorganic compounds 

Baseline 

At present, neither cadmium nor any cadmium compounds have been included in Annex 
XIV of REACH, the ‘Authorisation List’. However, a number of relevant compounds are 
at  earlier  stages  of  the  process,  which  may  lead  to  their  eventual  inclusion  into  Annex 
XIV. 
The  exposure  concentrations  have  been  declining  on  average  by  3%  per  year.38 
Individual consultation responses, however, have not identified any significant decreases 
over time. For the future, 0% change in exposure levels and numbers of workers exposed 
are expected.  

In the absence of any further action a limited number of cases of cancer and up to 280 
new cases of proteinuria are expected in the coming 60 years. This has been estimated to 
have a health cost of up to EUR 68 million. However, the fact that only one main cancer 
(lung)  and  one  main  non  cancer  health  effect  (elevated  proteinuria39)  have  been 
quantified indicates that the estimated burden resulting from not preventing it can likely 
be higher. 

Table 5: Baseline scenario over 60 years for cadmium and its inorganic compounds 

Types of cancer caused 

Other adverse health effects 

Number of exposed workers 
Change exp. Level 

Lung  cancer  (quantified),  kidney  and  prostatic  cancer  (not 
quantified) 
Proteinurea  (quantified),  osteotoxic  (toxic  to  the  bones)  and 
respiratory effects (not quantified) 
10 000 
Past: -7% p.a. (level and workers) 
Future: 0% 

38  This is a generic value that generates a combined 7% decline in the exposed workforce and exposure 

concentrations; this value is consistent with previous Commission impact assessments. 

39  Proteinuria is the presence of excess proteins in the urine. 

20 

 
                                                            
Past: -7% p.a. (level and workers) 
Future: 0% 
11 

5.8 

500 

180-280* 

5 
6-8 

EUR 5  million 
EUR 9-63 million 

Change no. of exposed workers 

Current disease burden (CDB) - no. of 
cancer cases 
Future disease burden (FDB)  
- no. of cancer cases 
CDB  no.  of  other  adverse  health 
effects 
FDB  no.  of  other  adverse  health 
effects 
Exp. no. of deaths FDB cancer 
Exp. no. of deaths FDB  other adverse 
health effects 
Monetary value FDB cancer 
Monetary  value  FDB  other  adverse 
health effects 
Based on RPA (2018) 
* Workforce turns over at 5% p.a. 

Impacts of the policy options 

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

Compliance and administrative costs for companies are the largest cost burden across all 
options. There are between 100 and 150 mainly large companies with workforce exposed 
to  significant  levels  of  cadmium  in  the  EU40.  The  costs  are  estimated  over  a  60  year 
period,  with  capital  expenditures  of  EUR  412 million  and  EUR  35 million  operating 
expenditures discounted to a present value for an OEL of 1 µg/m3.  

If the strictest value were to be adopted without any transition period, it could be that a 
very  limited  number  of  companies  or  business  units  might  relocate  (the  OELs  in 
competitor  countries  are  higher)  or  close  down,  with  some  associated  job  losses.  This 
could  have  some  negative  consequences  for  competitiveness  as  well  as  innovation. 
However,  a  transition  period  with  a  higher  initial  value  (as  in  option  3)  would  make  it 
possible for companies to anticipate the changes, gradually introduce improvements and 
plan necessary investments. As a result it is not expected that any closures or job losses 
would  occur.  A 
impact  on 
competitiveness and innovation. 

transition  period  will  also  mitigate  any  negative 

The  companies  in  the  key  sectors  are  generally  large  enterprises,  and  only  limited 
evidence  of  SMEs  in  the  key  sectors  has  been  found41.  The  increase  in  costs  due  to 
having  to  implement  more  or  better  RMMs  is  calculated  to  represent  in  the  region  of 
1.4% of average turnover at the 1 µg/m3 OEL. 

There is no impact expected for consumers or the environment. 

The main benefits across all options come from avoided ill-health, in particular avoided 
lung cancer and elevated proteinurea cases vis-à-vis the baseline. RPA (2018) monetised 
the health benefits for cadmium for 181 cases of elevated proteinuria under the constant 
workforce  scenario  for  the  baseline,  but  up  to  280  cases  can  be  prevented  under  an 

40  Located in the Czech Republic, Italy, Germany, France, the Netherland, Poland and the UK. 
41  There could be a few SMEs in particular in the recycling sector. However, since concentrations in the 
recycling  sector  are  not  that  high  and  they  are  likely  to  decline  significantly  in  the  future  as  their 
source is most likely very old TVs or incorrect handling of batteries. In terms of the costs, there should 
not be a big cost problem for the SMEs in the recycling sector. 

21 

 
 
                                                            
assumed  workforce  turnover  of  5%  p.a.  Options  2  and  3  are  also  associated  with  a 
significant  positive  effect  on  simplification  and  level  playing  field  as  currently  80%  of 
Member States' OELs are above the option 2 value and 75% above the option 3 value. 
This  is  particularly  relevant  for  this  industry  where  a  significant  number  of  affected 
companies operate across borders.  

Table 6: Multi-criteria analysis for cadmium and its inorganic compounds 

Impact 

Stakeholders 
affected 

Option 2 
1 µg/m3 
(ACSH) 

Economic impacts 
Compliance and 
administrative 
costs 

Transposition & 
enforcement 
Benefits from 
reduced ill health 

Single-market: 
consumers 
Simplification 
/level playing field 

International 
competitiveness 
Specific 
MSs/regions 

Option 3 
4 µg/m3 
(Lowest value, 
ACSH transition 
value) 

Option 4 
10 μg/m3 
(Highest value) 

€79–116 million  

€14-44 million  

Companies 

€447million 
assuming that no 
transition period is 
established 

Public sector 

Limited costs  

Limited costs  

Limited costs  

Reduction in 
cancer cases 
Reduction 
cases 
proteinuria 

in 
elevated 

6 

181 

6 

176 

4 

92 

Employers 

Public sector 

Moderate 
costs 
avoided:  €1.0-€1.4 
million 
Moderate 
costs 
avoided:  €4.6-€6.7 
million 

Moderate 
costs 
avoided:  €0.9-€1.3 
million 
Moderate 
costs 
avoided:  €4.5-€6.5 
million 

Limited 
costs 
avoided:  €0.5-
€0.7 million 
Moderate  costs 
avoided:  €2.4-
€3.4 million 

Consumers 

No/very low impacts identified 

Companies 

Companies 

MSs 

Significant positive 
impact 
% of MS currently 
above the OEL: 
75% 

Significant positive 
impact 
% of MS currently 
above the OEL: 
80% 
Potential negative impact, if no transition 
period is established 
AT,  BE,  BG,  HR, 
CY,  CZ,  DK,  EE, 
FI,  FR,  DE,  EL, 
HU,  IE,  LV,  LT, 
NL, PL, SI, ES, SE, 
UK 

AT,  BE,  BG,  HR, 
CY,  CZ,  DK,  EE, 
FI,  FR,  EL?,  HU, 
IE,  LV,  LT,  NL, 
PL, SI, ES, SE, UK 

Significant 
positive impact 
% of MS 
currently above 
the OEL: 55% 
Moderate 
impact 

AT,  BG,  HR, 
CY,  CZ,  DK?, 
FR,  HU, 
IE, 
LV, LT, NL, SI, 
SE, UK 

Social impacts 
Ill health avoided  Workers & 

Employment 

families 
Jobs lost 

Environmental impacts 
Environmental 
releases 
Recycling – loss of 
business 

Environment 

Recycling 
companies 

€9m-€59m 

€9m-€57m 

€5m-€30m 

Limited impact 

Very limited impact  Very limited 

impact 

No impact/limited impact 

Negative  impact  if 
no transition period 
is established 

No impact/limited impact 

Based on RPA (2018); NB: a transition period was not considered in the analysis  

22 

 
 
 
Comparison of the policy options 
Concerning  the  effectiveness,  an  OEL  of  1  µg/m3  (Option  2)  appears  as  the  most 
effective option as it will prevent all the cases of cancer and proteinuria expected under 
the baseline. Moreover, the ACSH agreement on the Option 2 value has to be considered 
when looking at the effectiveness of option 2. This OEL is backed by employers as well 
as workers and would thus be easier to implement and to enforce.  

Concerning the efficiency, the costs of option 2 are significant. The Employers Interest 
Group  noted  in  the  ACSH  opinion42  that  a  fundamental  change  to  the  OSH  risk 
the  redesign  and 
management  strategy 
commissioning  of  more  complex  air  cleaning  systems,  will  be  required  by  option  2. 
However,  by  combining  the  OEL  of  1  μg/m3  with  a  transition  period  of  7  years  at 
4 μg/m3 the costs for employers and also the impact on employment are mitigated, thus 
the efficiency of this option is increased.  

industry,  along  with 

the  cadmium 

in 

Concerning  coherence,  establishing  an  OEL  following  option  2  also  increases  the 
coherence  of  the  CMD  with  other  EU  policy  objectives,  including  the  Charter  for 
fundamental  rights.  It  also  increases  complementarity  with  REACH,  as  outlined  in 
chapter  4.  Moreover,  establishing  new  OELs  will  increase  legal  clarity,  provide  a 
common reference point that can be used as a practical tool by employers, workers and 
enforcers  to  assess  compliance  with  the  general  CMD  requirements,  and  will  also 
contribute  to  a  level-playing  field  for  businesses  across  the  EU  (see  chapter  3). 
Coherence  with  general  EU  priorities  and  policies,  as  well  as  with  the  Charter  of 
Fundamental Rights, is considered to be the highest for the strictest OEL, as it is the most 
protective of workers’ health. 

Option 2, with a transitional period of 7 years at the level of option 3, is therefore 
the preferred option. 

Criteria  

Table 7: Cadmium and its inorganic compounds – comparison of options 
Option 2: 1 µg/m3 
(ACSH opinion) 
+ 
- 
++ 

Option 3:  
4 µg/m3 
+ 
- 
+ 

Option 1: 
Baseline 
0 
0 
0 

Option 4:  
10 μg/m3 
≈ 
≈ 
+ 

Effectiveness 
Efficiency 
Coherence 

6.1.2.  Beryllium and inorganic beryllium compounds 

Baseline 

Around 54 000 workers in the EU are exposed to beryllium and its inorganic compounds. 
The  sectors  using  beryllium  that  have  been  examined  for  this  impact  assessment  are 
foundries,  metal  fabrication,  transport,  ICT,  specialist  manufacturers,  medical  devices, 
glass, construction, laboratories and recycling.  

The construction sector has been excluded from the baseline scenario, as there was little 
reliable data about exposed workers and affected enterprises in this sector. This exclusion 
might  lead  to  an  underestimation  of  the  numbers  of  workers  exposed  to  beryllium,  in 
particular  in  light  of  the  large  workforce  in  this  sector.  In  addition,  there  is  a  lack  of 
published data for the monetisation of chronic beryllium disease.  

42   The Employers Interest Group highlighted their preference of the use of an exposure biomarker over 
an  OEL  for  the  prevention  of  systemic  adverse  effects.  The  Workers  Interest  Group  supported  the 
approach of delivering an exposure-risk-relationship (ERR) for these compounds. 

23 

 
 
                                                            
Beryllium  is  not  on  the  authorisation  list  of  REACH  at  present  and  there  are  no 
restrictions. As such, these regulatory mechanisms are not imparting any direct impact on 
worker exposures.  

For  the  current  burden  of  disease,  it  is  assumed  that  the  numbers  of  workers  in  these 
sectors have decreased by 1% per year and the exposure concentrations have decreased 
by  3%  per  year.  The  estimates  for  the  future  burden  of  disease  are  based  on  the 
assumption  that  the  number  of  workers  exposed  to  beryllium  and  its  inorganic 
compounds and the associated exposure concentrations will slightly decrease. The main 
significant end health point for exposure to beryllium is chronic beryllium disease. 

In the absence of any further action, further 4 602 new cases of chronic beryllium disease 
are expected in the coming 60 years. Further, the estimated latency period for the disease 
is as short as two years, whereas the estimated treatment period is as long as thirty years 
with  fatality  rate  of  10%.  This  has  been  estimated  to  have  a  health  cost  between 
EUR 420 million and EUR 1.9 billion. 

The  below  table  illustrates  the  baseline  scenario  for  beryllium  and  its  inorganic 
compounds. 

Table 8: Baseline scenario over 60 years for beryllium and inorganic beryllium compounds 

Chronic  beryllium  disease  (quantified),  allergy  or  asthma 
symptoms, beryllium respiratory sensitisation, skin sensitisation, 
cardiovascular,  renal,  hepatic  and  haematological  effects  (not 
quantified) 
54 071 (excluding construction sector) 
Past: -3% per year 
Future: Expected 2% per year reduction 
Past: -1% per year  
Future: Expected 3% per year reduction 
Exposure  in  sectors  considered  in  this  study  over  the  past  40 
years: 3 807 
3 068 -4 602* 

307 - 460* 

EUR 290 million – EUR 1.9 billion 

Types of health effect caused 

No. of exp. workers 
Change in exposure levels 

Change number of exposed workers 

Current disease burden (CDB) - no. of 
chronic beryllium disease cases 
Future  disease  burden  (FDB)  -  no.  of 
chronic beryllium disease cases 
Exp. no. of deaths (FDB) from chronic 
beryllium disease 
Monetary  value  FDB  from  adverse 
health effects 
Based on RPA (2018) 
*Workforce turns over at 5% p.a. 

Impacts of the policy options 

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

Compliance and administrative costs for companies are the largest cost burden across all 
options.  Beryllium  is  mostly  used  by  SMEs.  There  are  about  5 800  companies 
consisting of 92% small, 7% middle and 1% large enterprises in the EU (excluding the 
construction sector) with workforce exposed to beryllium. 

The  costs  for  businesses  are  estimated  over  a  60-year  period  and  discounted  to  present 
value. At an OEL of 0.1 µg/m3, the capital expenditures for all businesses are estimated 
to be EUR 875 million with operating expenditures of EUR 128 million. At an OEL of 
0.2 µg/m3, the capital expenditures for all businesses are estimated to be EUR 87 million 
with  operating  expenditures  of  EUR  47  million.  At  an  OEL  of  0.6  µg/m3,  the  capital 

24 

 
 
expenditures  for  all  businesses  are  estimated  to  be  EUR  26  million  with  operating 
expenditures of EUR 16 million.  
For small companies, the costs per firm are estimated to range for an OEL of 0.1 µg/m3 
between EUR 21 425 to EUR 28 577, for an OEL of 0.2 µg/m3 between EUR 9 214 to 
EUR  14 904  and  for  an  OEL  of  0.6  µg/m3  between  EUR  2  862  to  EUR  4 940.  The 
highest costs will be faced by small companies in the sectors foundries, metal fabrication 
and  laboratories.  For  all  of  the  three  options  the  costs  for  a  small  company  as  a  %  of 
turnover is less than 0.25%. 

Stakeholders have expressed doubts about the feasibility for certain processes to achieve 
exposures  below  0.2  μg/m3  and  that  these  processes  could  move  outside  the  EU  if  a 
lower  OEL  is  set.  Under  the  strictest  OEL  of  0.1  μg/m3,  up  to  4%  of  companies  could 
potentially close due to technical difficulties achieving such a low OEL.  

Only  the  lowest  OEL  would  have  a  likely  negative  impact  on  competitiveness  due  to 
companies  exiting  the  market  and  (1)  removing  the  provision  of  specialist  services 
completely  and  (2)  causing  a  concentration  of  the  market  into  a  small  number  of 
companies.  Substitution  is  rarely  an  option  for  production  with  beryllium.  However, 
companies  are  expected  to  be  able  to  comply  with  OELs  above  0.2  μg/m3  and 
international  competitiveness  should  not  be  affected,  taking  into  account  a  proposed 
transitional  period.  The  aspects  likely  to  be  affected  are  innovation,  research  and 
development leading to new products in high technology areas where beryllium plays a 
key role such as electric cars and solar power. It is not possible though to determine the 
extent of these effects. Also, the global nature of the markets using beryllium means that 
companies  using  the  substance  outside  of  the  EU  will  be  at  a  competitive  advantage 
where  any  regulatory  requirements  in  force  locally  are  lower  than  the  proposed 
harmonised OELs.  

There is no impact on employment for an OEL starting with the lowest feasible OEL of 
0.2 μg/m3. Moreover, there is no impact expected for consumers or the environment. 

The  main  benefits  across  all  options  come  from  avoided  ill-health,  in  particular  from 
avoided  cases  of  chronic  beryllium  disease  vis-à-vis  the  baseline  and  from  improved 
level playing field for companies. 

Table 9: Multi-criteria analysis for beryllium and inorganic beryllium compounds, 
excluding construction 

Impact 

Stakeholders 
affected 

Option 2 
<=0.1 μg/m3 
(Lowest value) 

Option 3 
0.2 μg/m3 
(ACSH) 

Option 4 
0.6 μg/m3 
(Highest value, 
ACSH transition 
value) 

Economic impacts 
Compliance costs  Companies 
Company 
closures 
Transposition and 
enforcement 
costs 

Companies 

Public sector 

Benefits from 
reduced ill health 

Reduction in 
CBD cases 

Employers 

Public sector 

> €1 billion 

€130 million 

€40 million 

Significant impact  No impact 

No impact 

Limited costs 
95%  of  MS  would 
have to transpose 
2 800 -3 100 

Limited costs 
80%  of  MS  would 
have to transpose 
2 400 

Limited costs 
80%  of  MS  would 
have to transpose 
1 600 

Moderate 
> €17 million 
Moderate 
> €25 million 

Moderate 
€15 million 
Moderate 
€21 million 

Moderate 
€10 million 
Moderate 
€15 million 

25 

 
Stakeholders 
affected 

Option 2 
<=0.1 μg/m3 
(Lowest value) 

Option 3 
0.2 μg/m3 
(ACSH) 

Option 4 
0.6 μg/m3 
(Highest value, 
ACSH transition 
value) 

Significant 
positive  Reduction 
of 
highest 
OEL/lowest  OEL 
ratio from 50 to 6 

Significant 
positive  
% of MS currently 
the  OEL: 
above 
80% 
Significant 
AT,  BE,  BG,  HR, 
CY,  CZ,  DK,  EE, 
FR,  EL,  HU,  LV, 
LT,  RO,  SK,  SI, 
SE,  UK  plus  IT, 
LU, MT, NL, PT 

Significant positive 
of 
Reduction 
highest OEL/lowest 
OEL  ratio  from  50 
to ‘no difference’ 

Significant positive 
Reduction of highest 
OEL/lowest  OEL 
ratio from 50 to 6 

Limited impact 

Significant positive  
%  of  MS  currently 
the  OEL: 
above 
95% 

Significant positive  
%  of  MS  currently 
the  OEL: 
above 
80% 

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

Significant 
AT,  BE,  BG,  HR, 
CY,  CZ,  DK,  EE, 
FR,  EL,  HU,  LV, 
LT, RO, SK, SI, SE, 
UK  plus  IT,  LU, 
MT, NL, PT 

Impact 

Single-market: 
competition/ 
level playing 
field 

Single-market: 
consumers 

Companies 

Consumers 

Simplification 

Companies 

Specific 
MSs/regions 

Member 
States 

Health and social impacts 

Deaths avoided 

Workers & 
families 
Workers & 
families 

Significant  
270 - 302 

Moderate 
223 

Moderate 
150 

Workers 

€200 million 

> €240 million 

Ill health avoided 
including 
intangible costs 
Employment – 
social cost (salary 
lost) 
Environmental impacts 
All 
Environmental 
releases 
Based on RPA (2018);NB: a transition period was not considered in the analysis 

Moderate 
€17 – 180 million 

Neutral impact 

None 

< €140 million 

None 

Comparison of the preferred policy option 

Concerning the effectiveness, option 2 would have the most positive effect on preventing 
deaths and ill health but option 3 is quite closely matched. Option 3 is also the result of 
in-depth discussions between the representatives of workers, employers and governments 
in the ACSH. This OEL, backed by stakeholders, would thus be easier to implement and 
to enforce. The workers noted that an OEL should  in the future possibly go lower than 
0.2 μg/m3 to optimally protect workers. 

Beryllium is a respiratory sensitiser. Beryllium and beryllium compounds can also cause 
allergic  contact  dermatitis  or  a  granulomatous  skin  reaction  in  humans.  Beryllium 
compounds have been shown to be skin sensitisers in animal experiments. A notation for 
dermal and respiratory sensitisation is therefore recommended. 

26 

 
 
 
 
Concerning  the  efficiency,  option  3  has  the  best  cost-benefit  ratio.  The  Employers 
Interest Group noted in the ACSH opinion43 that achieving an OEL of 0.2 μg/m3 is a very 
challenging target in terms of technical feasibility. Therefore, the impacts on companies 
can be further mitigated by combining the OEL of 0.2 μg/m3 with a transition period of 5 
years at 0.6 μg/m3. Concerning the efficiency, the benefits outweigh the costs for option 
3. Moreover, by combining the OEL of 0.2 μg/m3 with a transition period of 5 years at 
0.6 μg/m3 the negative impact on companies created by possible additional costs can be 
further mitigated. 

Concerning  coherence,  establishing  an  OEL  following  option  3  also  increases  the 
coherence  of  the  CMD  with  other  EU  policy  objectives,  including  the  Charter  for 
fundamental rights. It increases complementarity with REACH, as outlined in chapter 4. 
It will 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  chapter  3).  Coherence  with  general  EU 
priorities and policies, as well as with the Charter of Fundamental Rights, is considered 
to be the highest for the strictest OEL, as it is the most protective of workers’ health. 

Option  3,  with  a  notation  'Sensitisation  (dermal  and  respiratory)',  and  with  a 
transitional  period  of  5  years  at  the  level  of  option  4,  is  therefore  the  preferred 
option. 

Table 100: Beryllium and inorganic beryllium compounds – comparison of options 

Criteria  

Effectiveness 
Efficiency 
Coherence 

Option 1: 
Baseline 
0 
0 
0 

Option 2: 0.1 μg/m3 
(Lowest value) 
++ 
- 
++ 

Option 3: 0.2 µg/m3 
(ACSH opinion) 
+ 
++ 
++ 

Option 4: 0.6 μg/m3 
(ACSH transition value) 
+ 
+ 
+ 

6.1.3.  Arsenic acid and its salts, as well as inorganic arsenic compounds 

Between  7 900  to  15 300  workers  are  estimated  to  be  exposed  to  inorganic  arsenic 
compounds, and 18 000 to 102 000 workers are potentially exposed at levels below the 
lowest OEL assessed.  

The  calculations,  by  not  including  the  larger  number  of  workers  (those  potentially 
exposed),  underestimates  the  total  current  burden  of  exposure.  Moreover,  the  dose-
response relationship (DRR) estimated as part of this study is based on limited available 
data.  The  estimate  must  be  considered  quite  uncertain  and  to  represent  the  order  of 
magnitude only.  

Inorganic arsenic compounds are intentionally used in the glass sector, electronics sector 
and the primary zinc sector. Whereas a large number of workers a few decades ago were 
exposed  at  high  levels  to  arsenic,  the  number  of  workers  and  exposure  levels  have 
decreased  markedly  due  to  restriction  of  some  of  the  main  uses  of  arsenic  compounds 
and due to implementation of better RMMs.  

43    The  Workers  Interest  Group  noted  that  the  OEL  should  be  reviewed  in  due  time  with  a  view  to 

lowering it to be protective against beryllium sensitisation. 

27 

 
 
 
                                                            
 
Unintentional  use  in  raw  materials  occurs  in  the  non-ferrous  metal  sector,  the  ferrous 
base  metal  sector,  the  energy  sector  and  the  chemical  sector.  Concerning  the 
unintentional use, arsenic is present typically in concentrations below 0.1%. However, it 
cannot  be  excluded  that  some  workers,  e.g.  in  maintenance  works  in  settings  with 
arsenic-rich dusts, could be exposed at levels above the lowest of the assessed OELs. In 
the  sectors  with  the  major  exposure  to  inorganic  arsenic  compounds,  the  arsenic  is 
present  as  unintentional  constituent  of  raw  materials  and  it  is  anticipated  that  these 
exposures will not be influenced by any actions under REACH.  

For the major sectors, no significant trend in exposed workforce is observed, but where 
data  is  available  the  number  of  workers  exposed  at  high  levels  shows  a  decrease.  The 
future trend is set at -1%. As for the exposure concentrations, with expected increasing 
arsenic  concentrations  in  the  raw  materials,  as  well  as  potential  further  exposures,  for 
example  in  recycling,  the  exposure  concentrations  would  increase  if  nothing  else  was 
done. However, this increase will likely be counterbalanced by RMMs.  

In the absence of any further action a limited number of cases of cancer and 574 cases of 
neurotoxic effects are expected in the coming 60 years. This has been estimated to have a 
combined health cost of EUR 39.6 million. Other related health effects such as cancer of 
skin, urinary bladder, kidney, liver and prostate have not been taken into account. 

The below table illustrates the baseline scenario. 

Table 11: Baseline scenario over 60 years for arsenic acid and its salts, as well as inorganic 
arsenic compounds 

Types of cancer caused 

Other adverse health effects 

No. of exp. Workers 

Change exp. Level 

Change no. of exp. Workers 

Lung cancer (quantified) cancer in the skin, liver, lungs, bladder and 
kidney (not quantified) 
Peripheral  neuropathy  (quantified),  cardiovascular  effects  and 
immunotoxicity, skin changes and black foot disease (not quantified) 
7 900-15 300 (assessed) 
18 000  –  102 000  (potentially  exposed  at  levels  below  the  lowest 
OEL assessed) 
Past: -8% 
Future: -1% 
Past: -2%  
Future: 0 
17.2 * 

20 

574 

905 * 

Current disease burden (CDB) - no. 
of cancer cases 
Future  disease  burden  (FDB)  -  no. 
of cancer cases 
Current disease burden (CDB) - no. 
of peripheral neuropathy cases  
FDB  no.  of  other  adverse  health 
effects  
Exp. no. of deaths FDB cancer 
Exp.  no.  of  deaths  FDB,  other 
adverse health effects 
Monetary value FDB cancer 
Monetary value FDB other adverse 
health effects 
* Excludes burden of disease from exposure to prohibited applications; first of all the former use in CCA 
wood preservatives, CCA-preserved wood, other biocides and pesticides which have been major exposure 
sources.  According  to  CAREX  data,  these  applications  accounted  for  half  of  the  exposed  workforce  in 
1993/97.  
Based on RPA (2018) 

EUR 16.356 million 
EUR 23.31 million 

16 
None 

28 

 
 
Impacts of the policy options 

Overall,  the  estimated  compliance  costs  are  very  small  compared  to  industry  activities. 
For an OEL of 10 μg/m3, one-off capital expenditures of businesses amount to EUR 11 
million,  and  recurring  operating  costs  to  EUR  10  million.  The  estimated  compliance 
costs over the 60 year period are below 0.5% of industry turnover per exposed worker. 
For  a  majority  of  affected  companies,  the  measures  needed  to  achieve  compliance  are 
respiratory protective equipment and therefore, the costs are more or less proportional to 
the number of workers. The highest impacts would be in the first year with relative high 
investment costs that need to be financed. The most affected sector is expected to be the 
copper sector. Comparing the compliance costs (CAPEX and OPEX) per exposed worker 
in  the  copper  sector  with  that  annual  turnover,  these  represent  a  maximum  of  5%  of 
turnover  in  the  first  year.  Although  this  could  be  challenging  in  case  the  affected 
company would have limited access to finance, it is still considered manageable.  

Overall,  there  is  no indication  of  significant  issues  for  SMEs  in  any  of  the  affected 
sectors. While a few of the affected production sites/companies in the copper sector are 
relatively  small,  they  are  owned  by  larger  companies  and  therefore  they  might  not  be 
formally  SMEs.  It  means  that  they  are  likely  to  have  access  to  technical  expertise  and 
financial resources that will ease the compliance with the considered OELs.  

The  impacts  of  introducing  any  of  the  OELs  on  competition  and  competitiveness  are 
estimated  to  be  relatively  modest  and  no  significant  impact  on  innovation  is  expected. 
Employment  and  the  environment  are  also  not  expected  to  be  affected  by  any  of  the 
options.  

The  main  benefits  across  all  options  stem  from  avoided  ill-health,  in  particular  from 
avoided cases of lung cancer and peripheral neuropathy disease vis-à-vis the baseline and 
from an increased level playing field for companies. 

The applications for authorisation under REACH for diarsenic trioxide have been studied 
for the preparation of this report. Increased releases to the environment are not expected 
from the application of lower OELs. Companies using arsenic acid and inorganic arsenic 
compounds  have  to  comply  with  the  Industrial  Emissions  Directive  2010/75/EU  
(integrated pollution prevention and control), as well as with site specific environmental 
permissions. 

The multi-criteria analysis in the table below summarises the main impacts. 

Table 12: Multi-criteria analysis for arsenic acid and its salts, as well as inorganic arsenic 
compounds 

Impact 

Economic impacts 
Compliance costs 

Transposition costs 

Benefits from reduced 
ill health 

Stakeholders 
affected 

Option 2 
10 μg/m3 
(ACSH) 

Option 3 
25 μg/m3 
(Mean value) 

Option 4 
50 μg/m3 
(Highest value) 

Companies exposing 
their workers 
Public sector 
Reduction in number 
of cancer cases 
Reduction in numbers 
of peripheral 
neuropathy cases 
Employers avoided 
costs 
Public sector avoided 

€21.2 million 
Limited impact  Limited impact 
3 

€11 million 

2 

€1.6 million 
Limited impact 
1 

574 

468 

393 

€2.8 million 

€2.3 million 

€1.9 million 

€1.3 million 

€1.1 million 

€0.9 million 

29 

 
 
 
 
costs 

Companies / Positive 
impact /level playing 
field 

MSs that would have 
to change OELs 
Companies that might 
be impacted 

Limited impact - no closures expected 

No impact 

No impact 

No impact 

Reduction of 
highest 
OEL/lowest 
OEL ratio from 
71 to 4 
No impact 

of 

Reduction 
highest 
OEL/lowest 
OEL  ratio  from 
71 to 9 
No impact 

of 

Reduction 
highest 
OEL/lowest 
OEL  ratio  from 
71 to 18 
No impact 

No or very 
limited impact 
AT,  BG,  HR, 
CZ,  EE,  FR, 
EL,  HU, 
IT, 
LT,  LU,  MT, 
PT, SK, SI, UK  

No impact 

No impact 

AT,  BG,  HR, 
CZ,  EE,  FR, 
EL, HU, IT, LT, 
LU,  MT,  PT, 
SK, SI, UK 

AT,  HR,  CZ, 
FR,  EL,  HU, 
IT,  LU,  MT, 
PT, SK, SI, UK 

Workers & families 

€9 to €34 
million 

€7 to €28 
million 

€5to €23 
million 

Workers & families 

Workers 

Additional  ill-health  from  other  types  of  cancer  and 
non-cancer  endpoints  not  included  in  the  assessment 
(expected to be lower than the assessed endpoints) 
No impact 
No impact 

No impact 

No impact (expected that exhaust air from ventilation 
systems is filtered before released to the environment) 

Recycling companies  No impact 

No impact 

Single-market: 
competition 
Single-market: 
consumers 
Single-market: 
internal market 

International 
competitiveness 
SMEs 

Specific MS/regions 

Social impacts 
Ill health avoided – 
lung cancer and 
peripheral neuropathy 
(incl. intangible costs) 
Other health points 

Employment 
Environmental impacts 
Environmental 
releases 
Recycling  –  loss  of 
business 
Recycling  –  durability 
of  consumer  goods, 
etc. 
Based on RPA (2018) 

Concerning effectiveness, option 2 will have the most positive impact on prevention of 
deaths and ill health compared to the baseline and other options. In addition, option 2 is a 
result  of  in-depth  discussions  between  the  representatives  of  workers,  employers  and 
governments in the ACSH and would thus be the easiest to implement and to enforce. 

Concerning  efficiency,  the  benefits  outweigh  the  costs  for  all  options.  This  is  also  the 
case for the most stringent OEL under option 2, where the calculation shows that benefits 
of almost 26 million EUR (method 1) outweigh costs of some 21 million EUR over 60 
years. However, the ACSH noted that the OEL could be technically challenging for the 
copper smelting sector, and a prolonged transitional period may be necessary. No other 
concerns  about  technical  feasibility,  overall  costs  or  impact  on  competitiveness  outside 
the EU have been raised by employers' representatives or government representatives.  

Concerning coherence, option 2 also increases the coherence of the CMD with other EU 
policy  objectives,  including  the  Charter  for  fundamental  rights.  It  will  increase  the 
complementarity  with  REACH,  as  outlined  in  chapter  4.  Moreover,  it  will  provide  a 
common reference point that can be used as a practical tool by employers, workers and 
enforcers  to  assess  compliance  with  the  general  CMD  requirements,  and  will  also 

30 

 
 
 
 
 
 
 
 
 
 
 
 
contribute  to  a  level-playing  field  for  businesses  across  the  EU  (see  chapter  3). 
Coherence  with  general  EU  priorities  and  policies,  as  well  as  with  the  Charter  of 
Fundamental Rights, is considered to be the highest for the strictest OEL, as it is the most 
protective of workers’ health. 

Option 2, with a transition period for copper smelting, is therefore the preferred 
option. 

Table 13: arsenic acid and its salts, as well as inorganic arsenic compounds 

–  comparison of options 

Criteria  

Option 1: 
Baseline 

Option 2: 10 µg/m3 
(ACSH opinion) 

Effectiveness 
Efficiency 
Coherence 

0 
0 
0 

++ 
+ 
++ 

Option 3 
25 μg/m3 
(Mean value) 
+ 
+ 
+ 

Option 4 
50 μg/m3 
(Highest value) 
+ 
+ 
+ 

6.1.4.  Formaldehyde 

Baseline 

Around 990 000 workers are estimated to be exposed to formaldehyde. Formaldehyde is 
used in a wide array of economic sectors, ranging from agriculture, forestry and fishing, 
manufacturing  of  food  products,  manufacture  of  textiles,  manufacture  of  leather  and 
related products, manufacture of wood and products of wood and cork - except furniture, 
manufacture  of  paper  and  paper  products,  manufacture  of  chemicals  and  chemical 
products, manufacture of basic pharmaceutical products and pharmaceutical preparations, 
manufacture of rubber and plastic products, etc. to professional, scientific and technical 
activities,  human  health  and  funeral  and  related  activities.  Given  the  many  and  various 
economic sectors formaldehyde is used in, there is only limited availability and reliability 
of  sector-specific  data  (i.e.  exposed  workers/companies;  exposure  concentrations  and 
currently implemented RMMs).44 

REACH  is  not  expected  to  impact  the  baseline.  Formaldehyde  is  registered  under 
REACH. However, its intermediate use in resins and chemical synthesis is not covered 
under  REACH45,  and  formaldehyde-based  resins  are  also  not  registered  as  they  are 
considered  as  polymers.  This  includes  resin  manufacturing  which  is  a  major  use  of 
formaldehyde.  Formaldehyde  use  is also covered under other regulations.  For example, 
the  use  of  formaldehyde  in  biocidal  applications  is  covered  by  the  Biocidal  Product 
Regulation and wood-based panels are covered under EN standards. 

44  No information was received from the consultation process for the following sectors which are sectors 
that  may  have  high  costs  for  implementing  the  proposed  OEL:  Manufacture  of  textiles  (NACE  Code 
C13),  manufacture  of  paper  and  paper  products  (NACE  Code  C17).  The  exposure  concentrations  for 
these sectors have been taken from a 2013 study by TNO Triskelion for Formacare. 
For Human health activities (NACE Code Q86) information was received only from Germany and the 
Netherlands. No information was also received for the sectors: manufacturing of food products (NACE 
Code C10), leather and related products (NACE Code C15), rubber and plastic products (NACE Code 
C22), electrical equipment (NACE Code C27), motor vehicles, trailers and semi-trailers (NACE Code 
C29),  furniture  (NACE  Code  C31),  and  the  construction  of  buildings  (NACE  Code  F41).  Literature 
review provided the basis for the values used in these sectors. 

45  Concluded from the risk management option analysis (RMOA) performed by ANSES in 2016 and from 

further clarification between ANSES and industry. 

31 

 
 
 
 
                                                            
The current burden of disease has been estimated assuming that the number of workers in 
the  relevant  sectors  has  been  decreasing  by  3%  per  annum  and  the  exposure 
concentrations have not changed. The number of cases expected to occur in the future is 
given below. It is assumed that the number of workers and exposure concentrations will 
remain stable in the future. 

In  the  absence  of  any  further  action  a  limited  number  of  cancers  and  19 200  cases  of 
sensory irritation are expected in the coming 60 years. This has been estimated to have a 
combined health cost between EUR 1.4 billion and EUR 8 billion.  

The below table illustrates the baseline scenario for formaldehyde.  

Table 14: Baseline scenario over 60 years for formaldehyde 

Types of cancer caused 

Other adverse health effects 

No. of exp. Workers 
Change exp. Level 

Change no. of exp. Workers 

Nasopharyngeal  cancer  (quantified),  leukaemia,  tumour  induction 
(not quantified) 
Sensory irritation (quantified), potential cancer precursor effects (not 
quantified) 
990 000 
Past: -5% p.a. (exp. level & workers) 
Future: 0% 
Past: -3% p.a. (exp. level & workers) 
Future: 0% 
330 per year (due to past exposure) 

7* 

19 200 cases of sensory irritation 

Current disease burden (CDB) - no. 
of cancer cases 
Future  disease  burden  (FDB)  -  no. 
of cancer cases 
CDB  no.  of  other  adverse  health 
effects 
FDB  no.  of  other  adverse  health 
effects 
Exp. no. of deaths FDB cancer 
Exp.  no.  of  deaths  FDB other 
adverse health effects 
Monetary value FDB cancer 
Monetary value FDB other adverse 
health effects 
Based on RPA (2018) 
In  case  of  formaldehyde  due  to  the  cumulative  nature  of  cancer  risk,  the  burden  caused  by  the  two 
modelled health endpoints is the same under both the worker ‘turnover’ and ‘no turnover’ scenarios. 

EUR 4 million to EUR 3 billion   
EUR 1 billion to  EUR 5 billion 

19 200 cases of sensory irritation* 

3 
0  

Impacts of the policy options 
SCOEL  has  derived  an  OEL  of  0.37  mg/m3  with  a  corresponding  short-term  exposure 
limit  (STEL)  of  0.738  mg/m3  since  sensory  irritation  is  a  concentration  rather  than  a 
cumulative  dose-driven  effect46.  The  costs  and  benefits  for  STEL  values  could  not  be 
monetised for formaldehyde. 

Formaldehyde is a well-known contact allergen to the skin (skin sensitiser). A notation 
'sensitisation (dermal)' is therefore recommended by SCOEL. 

It is estimated that 133 926 small enterprises, 8 384 medium and 9 039 large enterprises 
have  workers  exposed  to  formaldehyde  to  some  degree  in  the  EU.  EU  MS  with  more 
than  10 000  enterprises  using  formaldehyde  are  France,  Germany,  Italy,  Poland,  Spain 

46  There  are  insufficient  criteria  to  develop  a  dose  response  relationship  with  effects  at  other  selected 
short-term exposure limits (STELs); and there are potential issues for measuring the STEL which are 
discussed in the study accompanying the impact assessment.  

32 

 
 
                                                            
and the United Kingdom. No enterprises are expected to cease trading as a result of the 
introduction of any of the considered OELs. As a result, no impacts on competition are 
envisaged and also no significant impact on innovation is expected.  

All  options  are  associated  with  compliance  and  administrative  costs  for  companies. 
However,  the  compliance  costs  associated  with  meeting  even  the  strictest  OELs 
represent less than 1% of SMEs’ total turnover in the different sectors that would 
be affected. Consequently, workers are overall unlikely to lose their jobs as a result of 
the introduction of any of the OELs. Moreover, businesses may be able to absorb these 
cost increases without significant impacts on prices and, therefore on competitiveness or 
on consumers. For all small enterprises, an OEL of 0.37 mg/m3 would lead to estimated 
capital expenditures of EUR 21 million, but save the businesses operating costs of EUR 8 
million, totalling costs at 13 million over 60 years. Similarly, medium enterprises would 
face capital expenditures of EUR 257 million and save operating expenditures of EUR 81 
million over 60 years. 

Currently, businesses using formaldehyde face different OELs in different MS, with the 
ratio of the highest OEL to the lowest OEL being 20:1. In the event that an OEL of 0.6 
mg/m3 is introduced, that ratio would reduce to 4:147, to approximately 2:1 under an OEL 
of 0.37 mg/m3. Greater harmonisation will also benefit those businesses which already, 
or might wish to, operate in multiple Member States. 

The  main  benefits  across  all  options  come  from  avoided  ill-health,  in  particular  from 
avoided  cases  of  nasopharyngeal  cancer  and  sensory  irritation  vis-à-vis  the  baseline. 
Moreover, there is a significant positive impact from increased competition and from a 
level playing field for companies.  

Table 13: Multi-criteria analysis for formaldehyde 

Impact 

Stakeholders 
affected 

Option 2 
0.15 mg/m3 
(Lowest value) 

Option 3 
0.37 mg/m3 
(ACSH) 

Option 4 
0.6 mg/m3 
(Highest value) 

Economic impacts 
Compliance 
costs 
Transposition 
costs 
Benefits from 
reduced ill 
health 

Single market: 
competition 
Single-market: 
consumers 
Single market: 
internal market 

Companies 

€10.34 billion 

€1.72 billion 

€0.07 billion 

Public sector 

Limited impact 

Limited impact 

Limited impact 

Reduction in 
cases (lung 
cancer) 
Reduction in 
cases (sensory 
irritation) 
Reduction in 
DALYs 
Employers 
(avoided costs) 
Public sector 
(avoided costs) 
No. of company 
closures 

Consumers 

Companies 

7  

7  

7  

19 200 (on any given 
day) 

19 200 (on any given 
day) 

19 200  (on  any  given 
day) 

115 510 

115 510 

115 510 

€0.03 million 

€0.03 million 

€0.03 million 

€181 million 

€181 million 

€181 million 

0 

0 

0 

No impacts 
identified 
Significant positive 
impact 
Reduction of highest 

No impacts 
identified 
Significant positive 
impact 
Reduction of highest 

No impacts identified 

Positive impact 

Reduction of highest 

47  NL has the lowest OEL for formaldehyde of 0.15 mg/m3. 

33 

 
 
                                                            
International 
competitiveness 
Specific 
MSs/regions 

OEL/lowest OEL 
ratio from 20:1 to 
‘no difference’ 

OEL/lowest OEL 
ratio from 20:1 to 2:1 

OEL/lowest OEL ratio 
from 20:1 to 4:1 

Companies 

Limited impact 

Limited impact 

Limited impact 

MSs 

All except NL 

BE,  BG,  HR,  CY, 
CZ,  DK,  EL,  EE, 
HU, IT, LV, LT, LU, 
MT, PL, RO, SI, ES, 
UK 

BE,  BG,  HR,  CY,  EL, 
IT,  LU,  MT,  RO,  ES, 
UK 

Social impacts 
Ill health 
avoided (incl. 
intangible costs) 
Employment 

Workers & 
families 

Jobs lost 
Social cost 

€1 billion  or  €5 billion (depending on method applied) 

No impacts identified 
No impacts identified 

Environment 

Environmental impacts 
Environmental 
releases 
Recycling  –  loss 
of business 
Notes: All costs/benefits are incremental to the baseline (PV over 60 years). 
Based on RPA (2018) 

Limited impacts under all options 

Limited impacts under all options 

Recycling 
companies 

Concerning  effectiveness,  the  positive  effects  on  prevention  of  death  and  ill  health  are 
closely matched for all three options. All are expected to prevent 7 cases of cancer and 
19 200 cases of sensory irritation compared to the baseline. However, option 3 is a result 
of  in-depth  discussions  between  the  representatives  of  workers,  employers  and 
governments in the ACSH and the backing of all stakeholders will make it the easiest to 
implement and to enforce.  

Concerning the efficiency, option 2 is the most costly for business while not resulting in 
higher benefits in comparison to the remaining options. Benefits outweigh costs in both 
option 3 and 4, and in case of option 3 the Employers Interest Group in the ACSH did 
not note any difficulties in complying with the OEL of 0.37 mg/m3 other than for some 
specific processes48. No transition measures were requested by Employers Interest Group 
with regard to this OEL.  

Concerning coherence, establishing an OEL following option 3 increases the coherence 
of  the  CMD  with  other  EU  policy  objectives,  including  the  Charter  for  fundamental 
rights.  It  increases  complementarity  with  REACH,  as  outlined  in  chapter  4.  It  will 
provide  a  common  reference  point  that  can  be  used  as  a  practical  tool  by  employers, 
workers and enforcers to assess compliance with the general CMD requirements, and will 
also contribute to a level-playing field for businesses across the EU (see chapter 3). The 
stricter  the  adopted  OEL,  the  more  coherence  is  expected  in  general.  However,  in  this 
case all options score similar in terms of coherence. 

Option 3, with a notation 'dermal sensitisation ' is therefore the preferred option. 

Table 146: Formaldehyde – comparison of options 

48  The  Employers  Interest  Group  of  the  ACSH  noted  that  in  some  companies  and  for  specific  tasks, 
complying with the proposed OEL seems technically difficult, in particular for companies proceeding 
to  gluing  and  varnishing  using  mixtures  with  formaldehyde  or  formaldehyde  releasing  resins.  For 
those  companies,  achieving  the  proposed  OEL  would  therefore  require  new  equipment  and/or 
organisational measures, which would entail additional investment and costs.  

34 

 
 
                                                            
Criteria  

Effectiveness 
Efficiency 

Option 1: 
Baseline 
0 
0 

Coherence 

0 

Option 2: 0.15 mg/m3 
(lowest value) 
+ 
-- 
++ 

Option 3: 0.37 µg/m3 
(ACSH opinion) 
++ 
+ 

Option 4: 0.6 mg/m3 
(Highest value) 
+ 
+ 

++ 

++ 

6.1.5.  4,4'-Methylene-bis(2-chloroaniline) (MOCA) 

Baseline 

350  workers  are  estimated  to  be  exposed  to  MOCA  in  the  EU  across  around  89 
production sites. In addition, about 1 200 workers are indirectly exposed to MOCA via 
the dermal route. Exposure is not expected to change in the future. The key sector using 
MOCA is the plastics sector. The assessment of the baseline is done for two scenarios: 
under  the  assumption  that  the  REACH  authorisation  is  granted  and  the  use  of  MOCA 
continues for a period of time, and the assumption that authorisation is not granted and 
the use of MOCA discontinues.  

Both the current burden on disease due to past exposure and the future burden of disease 
are estimated at relatively low numbers. The exposure risk relationships (ERR) based on 
workplace  concentrations  and  urinary  level,  respectively,  are  both  established  by  the 
RAC and considered to reflect the current knowledge about the lung cancer effects of the 
substance.  

Table 15: Baseline scenario over 60 years for MOCA 

Types of cancer caused 
Other adverse effects 
No. of exp. workers 
Change exp. Level 

Change no. of exp. workers 

Current disease burden (CDB) - no. 
of  cancer  cases  based  on  previous 
50 years exposure 
Future  disease  burden  (FDB)  -  no. 
of cancer cases 
Exp. no. of deaths FDB cancer 
Monetary value FDB cancer 
Based on RPA (2018) 

Impacts of the policy options 

Lung cancer (quantified), bladder cancer (not quantified) 
No sufficient data available 
350 
Past - 4% 
Future -1% 
Past - 3% 
Future 0% 
0.0005 

0.0036 

0.0019 
EUR 3 000 

The  multi-criteria  analysis  indicating  impacts  and  stakeholders  affected  is  summarised 
below.  The  conclusions  are  drawn  on  the  basis  that  the  current  levels  of  exposure  is 
typically below the lowest of the OELs assessed and consequently the estimates are not 
sensitive  to  the  number  of  exposed  workers,  the  relationship  between  exposure  and 
effects  and  the  costs  of  cancer  cases.  The  uncertainty  is  consequently  related  to  the 
estimated exposure levels. 

All affected companies of a possible OEL for MOCA are  SMEs. In the application for 
authorisation  under  ECHA,  20%  are  micro,  65%  are  small  and  15%  are  medium  size 

35 

 
 
 
 
 
enterprises.  Two  thirds  of  estimated  workers  exposed  to  MOCA  work  in  moulders  at 
estimated 89 sites across the EU49. 

The total costs of compliance will depend mainly on the number of workers affected, as 
the main cost is estimated to be costs of monitoring, thus operating costs. The frequency 
for  monitoring  is  determined  nationally.  For  this  impact  assessment,  it  is  assumed  that 
companies  will  be  required  to  undertake  one  monitoring  programme  to  demonstrate 
compliance.  Capital  expenditures  for  businesses  are  not  expected.  The  unit  cost  of 
monitoring is found to be independent from the company size, as it mostly depends on 
the  consultant  and  laboratory  used50,  and  is  thus  expected  to  be  affordable  for  all 
businesses,  including  microbusinesses.  The  costs  of  monitoring  are  small  and  the 
economic  impact  on  each  company  will  be  negligible.  Thus,  establishing  a  reference 
OEL  of  (Option  2)  or  above  5 μg/m3  (options  3  and  4)  would  not  have  any  impact  on 
competition, competitiveness, innovation, employment or consumer prices. 

Establishing the reference OELs would have some positive impact on the level playing 
field and legal clarity. 13 MS51 have an OEL higher than the lowest assessed OEL of 5 
µg/m³ and 11 MS52 do not have any OEL. Only three MS53 have an OEL corresponding 
to  the  lowest  assessed  OEL  of  5  µg/m³.  The  ratio  of  highest  OEL/lowest  OEL  ratio  is 
currently 44. 

As exposure via the dermal route makes a substantial contribution to body burden, a skin 
notation is warranted for this carcinogen. 

The  applications  for  authorisation  for  MOCA  under  REACH  have  been  studied  for  the 
preparation  of  this  report.  The  operating  conditions  and  the  risk  management  measures 
that  the  applicants  will  have  to  comply  with  in  case  of  a  granted  authorisation,  will 
reduce  workers  exposure  as  well  as  releases  to  the  environment.  No  releases  to  the 
environment are expected from the application of the proposed OEL. 

Table 16: Multi-criteria analysis for MOCA 

Impact 

Stakeholders affected 

Option 2 
5 μg/m3 
(Lowest 
value) 

Option 3 
10 μg/m3 
(ACSH) 

Option 4 
20 μg/m3 
(Highest value) 

Companies 
their workers 
Public sector 

Employers 

Public sector 

Economic impacts 
Compliance and 
administrative costs 
Transposition and 
enforcement costs 
Benefits from reduced ill 
health 

Single-market: 
competition 
Single-market: consumers 
Single-market: internal 

exposing 

€701 000 

€701 000 

€701 000 

Limited costs  Limited costs 

Limited costs 

Limited 
impact 
Limited 
impact 
No impact identified for all options 

Limited 
impact 
Limited 
impact 

No impact 

No impact 

No impact identified for all options 
Limited impact of harmonisation effect of OEL 

49  According to the survey undertaken for the application for authorisation, users of MOCA are located 

50 

in BE, DK, FR, IT, IE, EL, HU, PT, ES, NL and UK. 
In  DK,  for  example,  the  costs  for  a  monitoring  programme  consisting  of  10  samples  (4  personal 
samples  and  6  stationary  samples  per  company)  are  estimated  to  be  €11,900;  of  these  47%  are  the 
costs of analysis 

51  AT, BE, DK, FI, FR, EL, NL, PL, PT, RO, SK, SI and ES 
52  BU, CY, CZ, EE, DE, HU, IT, LV, LT, LU and MT 
53 

IE, UK and HR 

36 

 
 
 
 
 
                                                            
market 
International 
competitiveness 
SMEs 
Specific MSs/regions 

** 
Public  sector,  Member 
States  without  an  OEL 
or higher OELs. 

Limited impact of harmonisation effect of OEL 

Monitoring costs are not significant 
AT, BE, BU, 
CZ, CY, DK, 
EE,  EL, ES, 
DE, FI, FR, 
HU, IT, LV, 
LT, LU, MT 
NL, PL, PT, 
RO, SK, SI 

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

BE, BU, CZ, 
CY, DK, EE,  
EL, ES, DE, FI, 
FR, HU, IT, 
LV, LT, LU, 
MT NL, PT, 
RO 

Companies (in MS with 
higher  or  without  an 
OEL) 

BE,  DK,  FR, 
EL,  NL,  PT, 
ES, HU, IT 

BE, DK, FR, 
EL, NL, PT, 
ES, HU, IT 

BE,  DK,  FR, 
EL,  NL,  PT, 
ES,  HU, IT 

Social impacts 
Ill health avoided 
Employment 
Environmental impacts 
Environmental releases 

Workers & families 
Workers 

Limited impact under all options 
No impacts under all options 

Environment 

No impacts under all options 

Recycling companies 

Recycling – loss of 
business * 
Recycling – durability of * 
consumer goods, etc. 
* MOCA is transformed by the use and not present at any significant concentration in recycled articles 
** All affected companies are micro sized enterprises and SMEs 
Based on RPA (2018) 

Manufacturers using 
secondary material 

No impacts under all options 

No impacts under all options 

Comparison of the policy options 

Concerning  effectiveness,  all  assessed  OELs  would  bring  similar  health  effects  as  the 
baseline.  However,  option  3  was  agreed  in  the  tripartite  ACSH54  by  all  the  Interest 
Groups. Thus, the endorsement by workers as well as employers will make it the easiest 
option to apply and enforce.  

Regarding  efficiency,  the  very  low  costs  associated  with  all  three  options  make  them 
comparable with the baseline. 

A substantial advantage of option 3 is its coherence and legal implications. Establishing 
an  OEL  following  option  3  increases  the  coherence  of  the  CMD  with  other  EU  policy 
objectives.  In  particular,  it  will  significantly  increase  complementarity  with  REACH, 
especially  that  it  is  based  on  the  same  scientific  advice.  The  new  OEL  will  provide  a 
common reference point that can be used as a practical tool by employers, workers and 
enforcers  to  assess  compliance  with  the  general  CMD  requirements.  This  is  especially 
important  in  case  of  a  substance  like  MOCA  which  is  primarily  used  in  SMEs.  It  will 
ensure  legal  stability  and  predictability  for  workers  and  companies  irrespective  of  any 
potential  changes  in  the  future  use  of  the  substance.  The  OEL  will  also  contribute  to  a 
level-playing field for businesses across the EU since at the moment 16 Member States 
have not yet established any national OELs (see chapter 2). 

Option 3, with a notation 'skin', is therefore the preferred option. 

54  The ACSH strongly recommends the Commission to adopt a skin notation preferably with a footnote 

and recital on the importance of biomonitoring under Directive 2004/37/EC. 

37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                            
Table 17: MOCA – comparison of options 

Criteria  

Effectiveness 
Efficiency 
Coherence 

Option 1: 
Baseline 
0 
0 
0 

Option 2: 5 μg/m3 
(Lowest value) 
≈ 
≈ 
+ 

Option 3: 10 µg/m3 
(ACSH opinion) 
+ 
≈ 
++ 

Option 4: 20 μg/m3 
(median / mode) 
≈ 
≈ 
+ 

6.2. Summary of the retained 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  chemical  agents  and 
groups of chemicals assessed in this report.  

The  table  below  summarises  the  retained  options  assessed  by  a  set  of  criteria.  Where 
available evidence presented in this assessment is in a range, covering several criteria, the 
midpoint is used to avoid ambiguity.  

i) Stakeholders' acceptance  
For all five assessed carcinogens, the assessment validates the position expressed in the 
opinion of the tri-partite ACSH as the retained option. The following rating is applied:  
XX –support by the ACSH 

ii) Legal clarity  
Setting  OELs  for  the  five  carcinogens/groups  of  carcinogens  will  improve  legal  clarity 
for employers and workers. The number of Member States that would need to introduce 
or  amend  national  OELs  corresponding  to  the  proposed  EU  value  is  used  to  gauge 
improvements in legal clarity.  
XX – legal clarity will be improved in half or more of the Member States  
X – legal clarity will be improved in less than half of the Member States  

iii) Size of the problem  
The numbers of workers potentially exposed to the carcinogens vary substantially. While 
CMD  amendments  will  be  useful  even  if  currently  only  few  workers  are  exposed  (for 
example  this  might  change  in  the  future),  an  immediate  impact  will  be  greater  when 
exposed populations are bigger.  
XXX – more than 100 000 exposed workers  
XX – between 50 000 and 99 999 exposed workers  
X – less than 50 000 exposed workers, and/or subject to REACH authorisation  

iv) Health benefits  
There is also a divergence in the size of monetised health benefits of introducing OELs.  
XXX – benefits over 100 million EUR  
XX – benefits between 10 million EUR and 100 million EUR  
X – benefits of less than 10 million EUR, and/or subject to REACH authorisation  

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

XXX – costs below 10 million EUR, and/or subject to REACH authorisation  
XX – costs between 10 and 100 million EUR  

38 

 
 
 
 
X – costs over 100 million EUR  

39 

 
 
 
Retained 
option  
OEL 
1 µg/m3 
4 µg/m3 
(7 years 
transition 
period) 
0.2 μg/m3 
0.6 μg/m3 
(5 years 
transition 
period) 
10 µg/m3 

Cadmium and its 
inorganic 
compounds 

Beryllium and 
inorganic 
beryllium 
compounds  

Arsenic acid and 
its salts, as well as 
inorganic arsenic 
compounds  
Formaldehyde 

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

Name of 
chemical agent 

Table 18: Summary of the retained options, by assessment criteria 
Legal 
clarity 

Size of the 
problem 

Health 
benefit 

Stake-
holder 
acceptance 

Limited 
costs for 
businesses 

XX 

XX 

X 
(XXX)1 

XX 

X 
(XX)2 

XX 

XX 

XX 

XXX 

X 
(XX)2 

0.37 mg/m3 

10 µg/m3 

XX 

XX 

XX 

XX 

XX 

XX 

X 
(XXX)1 

XX 

XX 

XXX 

XXX 

X 

X 

X 

XXX 

1 The estimates of the number of exposed workers vary according to the sources available.  
XXX would apply if the highest estimates and not the value used in the model calculations would be used. 
2 During the transition period the expected costs for businesses are lower and would fall into category XX 

7.  OVERALL IMPACT OF THE PACKAGE OF RETAINED OPTIONS 

7.1. 

Impact on workers 

The retained option package for the five substances under consideration should result in 
benefits  in  terms  of  avoided  work-related  ill-health  and  cancer  cases  and  related 
monetised  health  benefits,  including  the  related  consequences  such  as  suffering  of 
workers and their caring families, a reduced quality of life or undermined wellbeing. 

The study underlying the present assessment was limited to assessing the most sensitive 
cancer  endpoint  and  the  most  sensitive  other  adverse  health  effect  for  each  substance. 
Nevertheless, the chemical agents under consideration pose a range of other occupational 
hazards  and  the  available  data  is  not  sufficient  to  estimate  the  magnitude  of  the  global 
related  health  and  socio/economic  benefits  for  workers.  As  a  result,  and  taking  into 
account  general  estimates  of  costs  related  to  these  diseases,  it  could  be  expected  that 
benefits for workers could be considerable. 

The greatest assessable benefits are expected in relation to formaldehyde. The quantified 
benefits for workers from the avoidance of ill-health (nasopharyngeal cancer and sensory 
irritation  only)  are  estimated  from  the  use  of  two  methods  leading  to  a  wide  range  of 
benefits,  one  resulting  in  a  benefit  of  1  000 million EUR  and  the  other  in  a  benefit  of 
5 000 million EUR. 

40 

 
 
 
 
 
Overall, the proposed 5 OELs would in the longer term improve working conditions 
for  over  1 000 000  EU  workers  and  protect  over  22 000 workers  from  significant 
health problems. 

7.2. Impact on businesses 

As regards costs incurred by enterprises for risk reduction measures, the retained option 
will have some effect on capital and operating expenses for companies which will have 
to put in place additional protective and preventive measures. This will be in particular 
the case for cadmium and formaldehyde, where the total costs to industry of the retained 
option over the next 60 years are estimated to be about 448 million EUR and 1.72 billion 
EUR  respectively.  In  case  of  the  OEL  for  cadmium,  mainly  large  companies  would  be 
affected  and  in  case  of  formaldehyde  the  number  of  companies  is  high.  Therefore,  the 
cost per company in relative terms for both substances is expected to be modest. 

For the majority of considered carcinogens, impacts cannot be fully quantified based on 
available data but impacts on costs and conduct of business (including small and medium 
enterprises) are expected to be less than 1% of annual company turnover, as only some 
adjustments will need to be done in specific cases to ensure full compliance. The retained 
options will not impose any additional information obligations and will therefore not lead 
to an increase in administrative burdens on enterprises. 

Impact on SMEs 

For cadmium and inorganic arsenic compounds, SMEs are not significantly represented 
in  the relevant industries. By contrast, beryllium, formaldehyde  and MOCA are largely 
used by SMEs. 
Thus, SMEs specificities, their limitations and particular challenges have been duly taken 
into account in the overall analysis presented in chapter 6. The analysis has shown that 
usually costs which will be incurred by SMEs are affordable for the companies.  
The  most  significant  costs  are  foreseen  for  SMEs  dealing  with  formaldehyde  and 
beryllium.  However,  costs  for  SMEs  remain  well  below  1%  of  their  turnover,  and  no 
SME closures or employment effects are expected at the proposed OELs.  
Many  of the RMMs  required to  meet the OELs involve capital  expenditure, and SMEs 
might  face  higher  cost  of  finance  compared  to  large  companies.  Furthermore,  when  it 
comes to company decisions regarding investment in the different measures required to 
ensure compliance with the proposed OELs, larger companies will be able to make those 
decisions in relation to total turnover figures, and not necessarily only in relation to the 
smaller amounts represented solely by activities relating to beryllium and formaldehyde. 
However, even in the case of the most significant costs foreseen for SMEs in relation to 
formaldehyde  and  beryllium,  costs  for  SMEs  remain  well  below  1%  of  their  turnover, 
and no SME closures or employment effects are expected at the proposed OELs.  
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  retained  options  would  have  a  positive  impact  on  competition  within  the  internal 
market by decreasing competitive differences between firms operating in Member States 
with  different  national  OELs  and  providing  certainty  concerning  enforceable  exposure 
limit across the EU.  

41 

 
The retained options should not have a significant impact on the external competitiveness 
of EU firms. On the one hand, the detailed assessment provided above shows that in most 
cases  additional  compliance  costs  per  firm  are  modest.  On  the  other,  while  non-EU 
countries have established a wide range of exposure values that vary significantly across 
jurisdictions, the retained exposure values are not out of line with international practice.  

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

It  can  however  be  observed  that,  in  most  cases,  the  retained  option  fits  into  the  lower 
range  of  equivalent  measures  established  in  non-EU  countries  –  suggesting  that  these 
measures are achievable, reflect available good practice, and are relatively ambitious in 
aiming to set internationally high standards of worker protection.  

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

7.3. 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 retained option 
should contribute, although not significantly, to mitigate financial loss of 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 
to  normal  mechanisms  for  compliance 
improvement and enforcement, including informal conversations with employers as well 
as formal correspondence and legal enforcement action. 

take  place  according 

This will normally be brigaded for any  given employer with other OSH provisions (for 
example,  workplace  transport,  slips  and  trips,  machinery  safety,  stress)  rather  than 
specific to OELs. Specific reporting would only be the case where Labour Inspectorates 
undertake targeted 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.  

At the same time, establishing OELs, and other explicit references to a given carcinogen 
in  the  CMD  brings  clarity  regarding  legal  requirements,  and  so  facilitates  the  work  of 
inspectors by providing a helpful tool for compliance checks. Setting OELs at EU level 
would  also  limit  the  need  for  national  administrations  to  conduct  duplicating  scientific 
analyses. 

42 

 
7.4. Impact on fundamental rights 

The impact on fundamental rights is considered positive - in particular with regard article 
2 (Right to life) and article 31 (Right to fair and just working conditions which respect 
his/her health, safety and dignity). 

7.5. Subsidiarity, proportionality and REFIT 

In  view of the available scientific evidence it is  necessary to establish new OELs for a 
number of substances for inhalation exposures including for information on other routes 
of exposure (e.g. dermal) which could contribute significantly to the overall body burden 
of the 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 retained  option takes  into  account long  and intensive discussions with all 
stakeholders  (representatives  from  employees'  associations,  representatives  from 
employers' associations, and representatives from governments), including consideration 
of socioeconomic feasibility.  

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

Updating 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 
with a uniform level of minimum requirements designed to guarantee a better standard of 
health and safety. Action taken by individual 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. 
Further,  the  proposal  is  based  on  a  minimal  degree  of  harmonisation  of  Member  State 
systems which respects Member States' competences to set more stringent binding limit 
values. 

The proportionality principle is fully respected as the scope of the proposal is limited to 
setting  out  the  limit  values  for  five  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. 

Further,  the  proposal  includes  measures  for  mitigating  burdens  and  supporting 
compliance. As indicated in the impact assessment, the costs are 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.  

The  proposal  also  leaves  the  Member  States  the  option  of  keeping  or  setting  more 
favourable standards by allowing Member States to introduce more stringent OELs.  

Finally,  regarding  the  simplification  and  the  efficiency  improvement  of  the  existing 
legislation,  the  proposal  eliminates  the  need  for  Member  States  to  conduct  their  own 
scientific analysis to establish OELs 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.  

43 

 
8.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

8.1.  Monitoring arrangements 

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

Table 19: Core indicators and their data sources 

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

Indicators  

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

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

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

Monitoring arrangements/data sources for monitoring 
indicators  
The data sources for the monitoring of this indicator are: 
-  data  that  could  be  collected  by  Eurostat  on  occupational 
diseases  if  the  results  of  the  on-going  feasibility  study  are 
positive,  as  well  as  on  other  non-cancer  work-related  health 
problems  and  illnesses  in  accordance  with  Regulation  (EC)  No 
1338/200855. 
-  data  notified  by  employers  to  the  competent  national 
authorities  on  cases  of  cancer  identified  in  accordance  with 
national  law  and/or  practice  as  resulting  from  occupational 
exposure to a carcinogen or mutagen in accordance with Art. 14 
(8) of Directive 2004/37/EC, and which may be accessed by the 
Commission  in  accordance  with  Article  18  of  Directive 
2004/37/EC.  
- data submitted by Member States in the national reports on the 
implementation  of  EU  OSH  acquis,  submitted  in  accordance 
with Art. 17a of Directive 89/391/EEC. 
The monitoring of this indicator will require the comparison of 
the  expected  figures  on  the  burden  of  occupational  cancer  in 
terms  of  economic  loss  and  health  care  costs  and  the  collected 
figures on these matters after the adoption of the revision.  
The productivity loss and health care costs can be established on 
the basis of the data on the number of occupational cancer cases 
and the number of occupational cancer deaths (the arrangements 
for  the  collection  of  the  data  on  occupational  cancer  cases  are 
described supra in this table).  

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, there is an 
obligation for employers to ensure thatthe 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 is  carrying out  a  Healthy Workplaces  Campaign 
on  dangerous  substances  in  2018-2019  raising  awareness  and  providing  good  practice 
examples and has recently published the results of a feasibility study on the development 

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

OJ L 354/70, 31.12.2008. 

44 

 
                                                            
of a computer-assisted telephone survey to estimate workers' exposure to carcinogens in 
the EU56. Other initiatives include a Commission-funded project to establish by the end 
of  2019  a  first  version  of  a  database  on  occupational  exposure  for  some  hazardous 
chemicals. 

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

56      Available  at:  https://osha.europa.eu/en/tools-and-publications/publications/summary-feasibility-study-

development-computer-assisted-0/view 

45 

 
 
 
 
                                                            
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.  CONSULTATION OF THE RSB 
The draft impact assessment report was submitted to the RSB on 30 January 2018. After 
a written procedure, the RSB issued a positive opinion on 23 February 2018. 

The  table  below  summarises  the  revisions  introduced  in  response  to  the  RSB 
considerations and recommendations for improvement: 

Board Opinion’s recommendations  

Corresponding changes to the draft 

Main considerations 

The  report  does  not  sufficiently  explain  the 
rationale,  process  and  criteria  for  selecting 
which  chemical  substances  require  OELs,  both 
in general and for this particular initiative. 

select 

followed 

Section  5.1  explains  now  in  more  detail  the 
approach 
the  priority 
to 
carcinogens to be covered in this initiative. It also 
refers  to  Annex  9  of  this  report  where  the  whole 
selection process - including the rationale, process 
and  criteria  for  selecting  priority  substances  -  is 
described in detail.  

The report does not fully explain to what extent 
alternatives to the OELs agreed by the tripartite 
ACSH Committee constitute plausible options. 

The  report  clarifies  in  section  6.1  the  importance 
of the ACSH to establish consensus and how other 
options are presented as reference points. 

Further considerations 

The  report  should  more  fully  and  transparently 
explain  the  different  steps  of  the  process  and  the 
weighting  of  different  prioritisation  criteria  for 
selecting which chemical substances require OELs. 
This  discussion  could  also  highlight  possible 
differences  in  roles,  structures  and  approaches 
between different bodies (e.g. SCOEL, ACSH and 
RAC).  Doing  so  would  help  to  clarify  why  this 
initiative  appears  to  result  in  such  modest  impacts 
in terms of protection of workers from occupational 
cancers. The report should indicate how this limited 
selection  of  cancer-related  chemical  substances  is 
compatible  with  the  Commission's  commitment  to 
reach a total of 50 OELs by 2020. The report could 
also  indicate  how  the  Commission  intends  to 
proceed from here to reach this objective. 

As  indicated  above  the  prioritisation  process  is 
described  in  further  detail  in  section  5.1  and 
Annex 9. In this annex are also described the roles 
of  the  different  bodies  involved  in  the process  of 
setting binding OELs. 

The text also clarifies (in the Introduction) that the 
scope  of  this  initiative  is  much  broader  than  just 
five  substances.  Three  of  concerned  carcinogens 
are  substance  groups  which  comprise  a  large 
number of priority compounds (several tens). 

The revised text explains further the limitations of 
the  data  (notably  the  underestimation  of  the 
number  of  cases  as  only  the  most  sensitive 
endpoints were assessed) in sections 2 and 6. 

The  Introduction  of  this  report  clarifies  the 
Commission's intention to continue this important 
work and to propose further binding OELs in the 
future with a view to protect more workers. 

46 

 
 
 
 
 
The report should clarify to what extent and under 
what  circumstances  the  preferred  option  could 
deviate  from  the  OELs  agreed  by  the  ACSH 
Committee. Building on the additional information 
from  recommendation  (1)  above,  the  report  could 
better  explain  the  ACSH  opinion  and  what  risks 
follow  from  exceeding  the  limits  that  were  agreed 
between governments, workers and employers. 

the 

Given  the  possible  need  for  significant  upfront 
latency  of  chronic 
long 
investments  and 
diseases, costs are likely to be incurred long before 
the expected benefits materialise. The report could 
therefore  better  present  the  distribution  of  such 
costs and benefits over time. It could more clearly 
distinguish  between  one-off 
investments  and 
operating costs. 

The importance of the ACSH agreement in setting 
consensual  OELs  was  clarified  after  the  RSB 
opinion  in  section  6.  Generally,  the  role  of  the 
ACSH  is  addressed  throughout  the  report,  in 
particular in the introduction, section 5, section 6 
and Annex 9.  

The report now provides, per substance (in section 
the  capital  and  operational  expenditures 
6), 
estimated. 

3.  EVIDENCE, SOURCES AND QUALITY 

The assessment of health effects of the carcinogens subject to this proposal is based on 
the relevant scientific expertise from the Scientific Committee on Occupational Exposure 
Limits (SCOEL) and from the Committee for Risk Assessment (RAC). 

SCOEL was set up by Commission Decision 95/320/EC106 to evaluate the health effects 
of  chemical  agents  on  workers  at  work.  The  work  of  the  Committee  directly  supports 
Union regulatory activity in the field of occupational safety and health, when available.  

RAC prepares the opinions of ECHA related to the risks of substances to human health 
and  the  environment.  The  work  of  RAC  includes  examining  harmonised  classification 
and labelling, evaluating 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  assessing  the  applications  for  authorisation  of  chemicals.  Moreover, 
opinions  from  RAC  also  support  Union  regulatory  activity  in  the  field  of  occupational 
safety and health, when available. 

Both  SCOEL  and  RAC  develop  high  quality  comparative  analytical  knowledge  and 
ensure  that  Commission  proposals,  decisions  and  policy  relating  to  the  protection  of 
workers’ health and safety are based on sound scientific evidence. The Committees assist 
the  Commission,  in  particular,  in  evaluating  the  latest  available  scientific  data  and  in 
proposing  occupational  exposure  limits  for  the  protection  of  workers  from  chemical 
risks,  to  be  set  at  Union  level  pursuant  to  Council  Directive  98/24/EC  and  Directive 
2004/37/EC of the European Parliament and of the Council. 

Members  of  both  Committees  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 SCOEL and RAC recommendations which are summarised in the 
following table: 

47 

 
 
 
Table 20: Summary of SCOEL recommendations and RAC opinions for the five carcinogens 

Carcinogen: 

SCOEL 
recommendation 
8 hrs TWA 

STEL 15' 

skin 
notation 

other 
notations 

others 

Cadmium and its 
inorganic 
compounds 57 

1 μg/m3 
(inhalable 
fraction) 

none 

none 

Beryllium and 
inorganic beryllium 
compounds 59 

0,00002 mg/m3 
(inhalable 
fraction) 

0,0002 
mg/m3 

none 

Sensitisation 
(dermal and 
respiratory)  

BLV: 2 μg 
Cd/g 
creatinine in 
urine(samp-
ling time not 
critical) 
BGV: 0.00004 
mg beryllium/l 
urine (samp-
ling time not 
critical)  

SCOEL 
carc. 
group 
C58 

C 

Arsenic acid and its 
salts, as well as 
inorganic arsenic 
compounds60 

RAC 
opinion 
8 hrs TWA 

skin 
notation  

others 

LTCR 

not derived 

see  following 
table 

BGV61: 
10 μg As/l 
urine (post-
shift sample at 
end of a 
working week) 

57  SCOEL (2017): Recommendation from the Scientific Committee on Occupational Exposure Limits for Cadmium and its inorganic compounds. SCOEL/OPIN/336. Available at: 

https://circabc.europa.eu/sd/a/13cad802-1f3c-40c0-bce4-6838cf5fc4ff/OPIN-336%20Cadmium%20and%20its%20inorganic%20compounds.pdf 

58  genotoxic carcinogen for which a mode of action-based threshold is supported and a health-based OEL is proposed 
59  SCOEL  (2017):  Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for  Beryllium  and  inorganic  beryllium  compounds.  SCOEL/REC/175. 

Available at: https://circabc.europa.eu/sd/a/33c8921a-1dbe-4410-909c-2d4c63d8fb1d/REC-175%20Beryllium%20and%20compounds.pdf 
60  RAC (2017): Opinion on Arsenic acid and its inorganic salts. Committee for Risk Assessment, European Chemicals Agency. Available at: 

https://echa.europa.eu/documents/10162/13641/opinion_arsenic_en.pdf/dd3eb795-108e-5d3a-6847-dddcc021a9dc 

61  BGV is recommended to be updated when more data becomes available on the speciated As3+ and As5+ levels among European population  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                            
Formaldehyde63 

4,4'-Methylene-
bis(2-chloroaniline)  
(MOCA)64,65 

0,369 mg/m3 
(0,3 ppm) 
not feasible to 
derive 

0,738  mg/m3 
(0,6 ppm) 
not 
to derive 

feasible 

x 

Sensitisation  
(dermal) 

C 

BGV: 
footnote66 

see 

A67 

not derived 

x 

as combined 
As3+, As5+ 
and MMA and 
DMA62 

BGV:  
LoD of 
biomonitoring 
method (e.g. 
</= 0.5 
μmol/mol 
creatinine, post 
shift sample 
end of the 
working 
week68 

1 μg/m3 : 
9.65 x 10-6 
2 μg/m3 : 
1.93 x 10-5 
5 μg/m3 : 
4.83 x 10-5 
10 μg/m3 
9.65 x 10-5 

62  Dietary sources, especially seafood may have a significant impact on total MMA (monomethylarsonic acid) and DMA (dimethylarsinic acid) levels  
63  SCOEL (2016):  Recommendation from the Scientific Committee on Occupational Exposure Limits for Formaldehyde. SCOEL/REC/125. Available at: 

https://circabc.europa.eu/sd/a/2882e9bc-d52e-4944-ac08-974b43957ed2/REC-125%20Formaldehyde.pdf 

64  RAC (2017): Opinion on 4,4’-methylene-bis-[2-chloroaniline] (MOCA). Committee for Risk Assessment, European Chemicals Agency. Available at: 

https://echa.europa.eu/documents/10162/13641/opinion_moca_en.pdf/35756093-0eb9-e468-2ba2-786ca73c5aaa 

65  SCOEL (2010/2013):lhttps://circabc.europa.eu/d/a/workspace/SpacesStore/c1212f38-05dd-4a76-9655-6303c9c4c93d/SUM%20174%204.4-Methylene-bis-(2-

66 

chloroaniline)%252c%20MOCA%202010%20with%20Annex%202013.pdf 
In the Annex to SCOEL/SUM/174 (2013) the following is stated: “Since the general population is not exposed to MOCA, MOCA is not detected in the urine of occupationally non-
exposed people. This means that urinary levels of occupationally non-exposed stay below the detection limit of the method, which typically lay around 1–1.5 μg/l (3.7–5 nmol/l, ~ 
0.37–0.5 μmol/mol creatinine) with commonly used analytical methods, some methods reported to reach the detection limit of 0.1μg/l. Thus, the Biological Guidance Value (BGV) 
for MOCA corresponds to the detection limit of the biomonitoring method’. SCOEL concluded that in occupationally exposed populations, urinary MOCA levels (total MOCA in 
the  urine)  below  5  μmol/mol  creatinine  can  be  reached  using  good  working  practices  at  the  workplace.  By  referring  to  the  cancer  risk  estimation  by  DECOS  using  linear 
extrapolations from animal testing, this urinary MOCA level corresponds to a cancer risk of 3–4 × 10-6.”  

67  non-threshold genotoxic carcinogen 
68  Using modern analytical methods, the limit of detection is usually 0.5 μmol/mol creatinine or below (See Annex to SCOEL/SUM/174 (2013): Recommendation for a Biological 

Guidance Value)  

49 

 
 
 
 
 
 
 
 
 
                                                            
Excess  lifetime  (up  to  age  89)  lung  cancer  risk  estimates  for  workers  exposed  at  different 
8h-TWA concentrations of inorganic arsenic 

(inhalable particulate fraction) for 40 years  

Arsenic acid and its salts, inorganic 
arsenic compounds  

exposure concentration – inhalable 
fraction (μg/m3)  

Excess lung cancer risk in EU workers (x10-3)  

10  

5  

2.5  

1  

0.5  

0.25  

0.1  

0.01  

1.4  

0.71  

0.36  

0.14  

0.07  

0.036  

0.014  

0.0014  

Studies performed by external consultants 

The Commission published in February 2017 an open call for tender in order to carry out 
an assessment of the social, economic and environmental impacts of a number of policy 
options  concerning  the  protection  of  workers  health  from  risks  arising  from  possible 
exposure to carcinogenic chemical agents at the workplace. 

The main outputs were a study report containing full reports on 5 carcinogenic chemical 
agents  and  one  other  policy  issues  detailing  the  setting  of  occupational  exposure  limit 
values across the 28 EU MS and the main economic competitor countries of the EU.  

The contract started on 18 July 2017 and runs until 17 February 2018. The outcome of 
this study provides the main basis for this Staff Working Document and is summarised in 
the relevant sections of this document. 

50 

 
 
 
 
 
 
 
 
 
 
 
Annex 2: Stakeholder consultation  

1. Social Partner Consultation 

1.1. Results of the first phase Social Partners consultation 

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

The  Commission  consulted  the  Social  Partners  on  the  establishment  and/or  revision  of 
further binding OELs in Annex III to the CMD as well as sought their views on which 
carcinogens  and  mutagens  could  be  added  in  future  reviews  of  the  Directive  for 
regulation under Annex I and/or Annex III to the Directive.  

Following a process described in more detail in Annex 6 of this report, the Commission 
identified  a  list  of  priority  substances  in  the  first  phase  consultation  document69,  as 
follows: 

(1) For a third amendment of the Directive (to be adopted early 2018) to establish and/or 
revise binding OELs for the following carcinogens: 

(a)  Cadmium and its inorganic compounds under the scope of the CMD 

(b)  Beryllium and inorganic beryllium compounds under the scope of the CMD 

(c)  Arsenic acid and its salts, as well as inorganic arsenic compounds under the 

scope of the CMD 

(d)  Formaldehyde [CAS No 50-00-0] 

(e)  4,4'-Methylene-bis(2-chloroaniline) (MOCA) [CAS No 101-14-4] 

(2) For a subsequent amendment, a first proposed list of the following three substances, 
which can be expanded, includes: 

(f)   Nickel compounds under the scope of the CMD 

(g)  Acrylonitrile [CAS No 107-13-1] 

(h)  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. 

69  Consultation  Document  of  26.7.2017,  First  phase  consultation  of  Social  Partners  under  Article  154 
TFEU on revisions of Directive 2004/37/EU to include binding occupational exposure limit values for 
additional carcinogens and mutagens; C(2017) 5191 final. 

51 

 
 
 
 
 
 
 
                                                            
Possible improvements to the EU legal framework 

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. However, ETUC and 
EFBWW  consider  it  necessary  to  extend  the  scope  of  the  CMD  to  include  reprotoxic 
substances, and to streamline this field with other policy areas such as public health and 
environment.  

Concerning  the  approach  regarding  the  third  and  fourth  amendments,  ETUC  and 
EFBWW agree with the list of 8 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.  

With regard to Annex I to the CMD, ETUC considered important to include all processes 
generated  substances  for  which  IARC  monographs  are  available.  More  specifically, 
concerning diesel engine exhaust emissions ETUC considers that it should be addressed 
as soon as possible, while not delaying the Commission's adoption of the third and fourth 
batches  of  proposals  for  revising  the  CMD.  In  the  enclosed  annex  of  its  priority 
substances  list  ETUC  has  indicated  it  as  a  candidate  for  the  fourth  amendment.  ETUC 
also  suggests  that  the  OEL  for  crystalline  silica  is  set  at  50  µ/m3.  EFBWW  expressed 
similar  views  concerning  diesel  engine  exhaust  emissions  and  crystalline  silica.  CESI 
suggested  carrying  out  in-depth  study  to  identify  other  processes  and  /  or  process 
generated substances for inclusion in Annex I of the CMD.  

Among  other  issues,  ETUC  and  EFBWW  stressed  the  need  for  more  consistent  and 
transparent criteria for setting OELs and for better cooperation between the expert groups 
working on OELs at the EU level as well as in Member States, and that purely health-
based OELs should prevail whenever possible. Further, ETUC suggested the need to take 
into account multiple exposures and improve the availability and quality of data.  

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. 

Apart from the revision of the CMD, ETUC and EFBWW suggested to adapt other EU 
legislation  to  establish  a  coherent  strategy  for  fighting  occupational  cancers,  e.g. 
concerning asbestos, solar radiation and others.  

Willingness to enter into negotiations 

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. 

52 

 
 
 
 
 
Employers' organisations 

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. 

Possible improvements to the EU legal framework 

Concerning  the  issues  identified  in  the  consultation  paper,  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, socio-
economic  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.    

Concerning  the  third  amendment,  BusinessEurope  overall,  supported  the  Commission's 
approach.  For subsequent amendments they 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.  They  emphasized  the  benefit  of 
recommending  Biological  Limit  Values,  where  scientifically  justified  and  relevant. 
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.  

Subject 
Commission’s current approach for periodic revision of Annex III of the CMD. 

the  employers'  organisations  agreed  with 

the  above  mentioned, 

the 

Concerning  Annex  I,  UEAPME  agreed  with  the  Commission's  approach  for  periodic 
revision. BusinessEurope and ECEG felt it was of limited benefit as it is often not clear 
to  which  specific  substance  exposure  should  be  reduced  or  avoided  and  to  which 
extent/level.  Instead,  BusinessEurope  suggested  to  consider  possibility  to  move 
substances  already  included  in  Annex  I,  where  relevant,  to  Annex  III,  if  the  chemicals 
which are responsible for the hazard have been identified.  

53 

 
 
 
 
Willingness to enter into negotiations 

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 Social Partners consultation 

The  Commission  launched  a  second  phase  consultation  of  the  Social  Partners.  The 
consultation document considers the possible avenues for EU action to improve workers' 
protection against carcinogens or mutagens. The second phase consultation closed on 22 
December 2017. 

In  the  second  phase  consultation,  the  Commission  indicated  that  adding  new  OELs  for 
five  chemicals  –  as  specified  in  the  first  phase  consultation  –  would  be  an  appropriate 
action to be included in the third amendment of the CMD. For subsequent amendments 
of the CMD, 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] 

  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 approach. 

Furthermore,  the  Commission  indicates  that  it  will  give  due  consideration  to  further 
suggestions received regarding the following substances: 

  Crystalline  silica:  in  light  of  the  compromise  reached  between  the  European 
Parliament and the Council during the negotiations on the first amendment on the 
CMD, the Commission will assess the situation as soon as new evidence becomes 
available. 

  Reprotoxic  substances:  the  Commission  will  assess  by  the  first  quarter  of  2019 
the  option  of  amending  the  scope  of  the  CMD  to  include  these  substances.  In 
addition,  on-going  work  on  the  best  way  to  tackle  endocrine  disrupters  is  being 
carried out. 

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. 

54 

 
 
 
 
 
 
 
Views on the possible avenues for EU action 

As regards the scope of the CMD, ETUC insists on including reprotoxins and EFBWW 
sees  the  need  to  work  on  a  concept  to  assess  and  evaluate  exposures  of  workers  to  a 
mixture of dangerous and carcinogenic or mutagenic and reprotoxic substances.  

The workers' organisations consider necessary the revision of Annex I. ETUC proposes 
to include all the work activities with a risk on occupational cancer, taking into account 
the  findings  of  the  IARC.  In  that  sense,  they  suggest  to  introduce  the  wording 
"occupational  exposure"  in  Article  2  and  in  the  title  of  Annex  I  of  the  CMD.  EPSU 
considers that Annex I should include activities such as cleaning, transport, laundry and 
waste  disposal  of  hazardous  drugs,  personal  care  for  patients  under  treatment  of 
hazardous  drugs,  and  preparation,  administration  or  disposal  of  hazardous  drugs, 
including  cytotoxic  drugs.  ETUC  also  highlights  the  importance  of  addressing  workers 
health  and  safety  related  to  cytotoxic  treatments.  Finally,  EFBWW  suggests  including 
DEEE in Annex I and stresses the need to map the use and emissions of work equipment 
with engines in order to identify the substances that are possible candidates for the CMD. 

Concerning  Annex  III,  the  workers'  organisations  agree  that  the  selection  of  the  third 
batch  and  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 socio-
economic  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.  

With regard to specific substances, EFBWW calls on the Commission to set a BOEL of 
0.3  ppm  for  formaldehyde,  based  in  the  SCOEL  recommendation  and,  together  with 
ETUC, consider that existing evidence on crystalline silica is sufficient to start the work 
and prepare a new BOEL of 0.05 mg/m3 to be introduced in Annex III (common position 
between ETUC, EFBWW and IndustriAll adopted on 1st March 2017). 

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.  ETUC 
highlights the need to integrate, in the framework of the roadmap, a gender perspective 
and  to  adopt  specific  rules  for  occupational  exposures  to  substances  such  as  endocrine 
disruptors  and  nanomaterials.  ETUC  proposes  a  future  OSH  legislation  on  chemicals 
built on three levels: a first block of general obligations defined in the Chemical Agents 
Directive (CAD), a second block of stricter obligations defined in the CMD for very high 
concern  substances,  and  a  third  block  of  specific  prohibitions.  They  are  opened  to  the 
idea of merging CAD and CMD. 

55 

 
 
 
Among other issues, ETUC considers that the issue of enforcement of the CMD should 
be addressed by the Commission, as well as the coordination between workers protection 
and market regulations. 

Willingness to enter into negotiations 

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. 

Views on the possible avenues for EU action 

Concerning  the  amendment  of  the  scope  of  the  CMD,  UEAPME  and  CEEMET  are 
against the inclusion of reprotoxic substances. BussinessEurope call on the Commission 
to  ensure  transparency,  regular  information  and  involvement  of  employers  in  the  study 
that will be undertaken by contractors on behalf of the Commission on these substances. 
As regards DEEE, the employers' organisations agree on the complexity of the issue and, 
while  UEAPME  believes  that  the  CMD  is  not  the  adequate  piece  of  legislation  to  deal 
with them, BusinessEurope and CEEMET have reservations and think that work needs to 
continue to gather enough evidence and to assess the implications and the technical and 
economic feasibility of the different options. 

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 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.  

As regards the amendment of Annex III, the employers' organisations support the list of 
priority  carcinogens  included  in  the  third  batch.  UEAPME  points  that  any  limit  value 
lower than 200ng/m3 for 15 min for beryllium, is severely challenging for SMEs, while 
complying with the limit value of 0,3 ppm of formaldehyde for 8h is technically difficult 
for companies in several industries. 

56 

 
 
 
 
BusinessEurope  encourages  the  Commission  to  continue  its  preparatory  work  and 
consultations  with  the  ACSH  regarding  the  candidate  list  of  substances  for  the  fourth 
batch. Regarding crystalline silica, UEAPME believe that lowering the limit value would 
be technically impossible and too burdensome for small businesses. 

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. 

Willingness to enter into negotiations 

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 all priority substances foreseen for the third amendment of the CMD70. 

The ACSH is proposing as possible approaches for these chemicals a binding OEL for all 
of them and in addition a skin notation for MOCA. 

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

Regarding the options proposed referring to biological monitoring or binding biological 
limit values; it has to be kept in mind that it is currently legally not possible to establish 
such limit values under the CMD   

Cadmium and its inorganic compounds under the scope of the CMD 

The ACSH agreed on two approaches in its opinion, adopted on 31 May 2017: 

  Approach 1:  

1 μg/m3 (inhalable fraction, 8h TWA), with a transition period of 7 years (to end 
no later than 2027) at 4 μg/m3 (inhalable fraction, 8h TWA). 

  Approach 2: 

To combine an airborne OEL  with  the biological monitoring value  proposed  by 
SCOEL  which  could  be  used  as  a  mean  of  demonstrating  control  of  workers' 
exposure in those Member States where biomonitoring is carried out. This would 
be based on complying with both the SCOEL biomonitoring value of 2 μg Cd/g 
creatinine  in  urine  and  the  8  hour  TWA  of  4  μg/m3  (respirable  fraction)  as 

70  The exact text of the ACSH opinions can be found  on CIRCA-BC under the following links: 

Formaldehyde: https://circabc.europa.eu/sd/a/25162551-6341-46d1-9e90-
4360cd6a1d0d/Doc.1280_EN-WPC%20June%20Opinion%20Formaldehyde.pdf 
Beryllium: https://circabc.europa.eu/sd/a/7e95cab5-6c71-4cbc-8147-f1f6d460ba2f/Doc.662-17-
EN_WPC_Opinion%20on%20Be_Adopted%2031.05.2017.pdf 
Cadmium: https://circabc.europa.eu/sd/a/bf0521f0-b54a-4712-b256-a30d7adcfdf6/Doc.663-17-
EN_WPC%20Opinion%20Cadmium_Adopted%2031.05.2017%20.pdf 

  MOCA: https://circabc.europa.eu/sd/a/2214b88e-5a69-4c2e-a98a-331aa13dc264/Doc.1336_EN-

WPC_Opinion%20MOCA_Adopted%2019102017.pdf 
Arsenic acid and its salts: https://circabc.europa.eu/sd/a/9813acc5-604a-49f9-9d4b-
afaeceb12705/Doc.1334_01_EN_WPC_Opinion%20Arsenic_Adopted%2019102017.pdf 

57 

 
 
 
 
                                                            
 
 
 
 
recommended  by  SCOEL/  OPIN/336  (page  10  paragraph  2,  adopted  8th  of 
February 2017). 

Beryllium and inorganic beryllium compounds under the scope of the CMD 

The ACSH adopted its opinion on 31 May 2017 putting forward the following values: 

  An  8  hour  TWA  of  200  ng/m3  (inhalable  fraction)  with  a  value  of  600  ng/m3 

(inhalable fraction) during a transitional period of 5 years. 

The  biological  value  of  0.04  μg  beryllium/l  urine  recommended  by  SCOEL  is  agreed, 
and the ACSH suggests that the OEL in Annex III of the CMD should include a footnote 
to indicate the importance of biomonitoring for beryllium exposure risk management. 

Notations: dermal and respiratory sensitisation. No skin notation suggested. 

Arsenic acid and its salts, as well as inorganic arsenic compounds under the scope of 
the CMD 

The ACSH adopted the following opinion on 19 October 2017: 

  The three interests groups agreed on the need for an EU OEL for arsenic acid and its 
salts as well as inorganic arsenic compounds under the scope of the CMD of 10 µg/m3 
(TWA  8  hrs  measured  as  arsenic)  inhalable  fraction.  However  after  a  preliminary 
assessment  for  one  specific  sector,  copper  smelting,  it  is  currently  not  technically 
achievable to comply with.  

  In addition the Commission impact assessment may identify other sectors which are in 
a similar situation. For all these sectors a prolonged transitional period may be necessary.   

Formaldehyde 

The  ACSH  adopted  an  opinion  on  9  September  2016  putting  forward  the  following 
values 
  An  8  hour  TWA  of  0.3  ppm  (0.369  mg/m3)  and  a  15  min  STEL  of  0.6  ppm  (0.738 
mg/m3) 

SCOEL  recommended  in  its  opinion  on  formaldehyde  to  add  a  notation  for  dermal 
sensitisation. The ACSH has not discussed this notation; however, as formaldehyde is a 
well-known contact allergen to the skin (skin sensitiser) it is appropriate to add a notation 
'sensitisation (dermal)'. 

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

The ACSH concludes in its opinion, adopted on 19 October 2017:  

  The major exposure route of MOCA is the dermal route. Therefore there should be a 
skin  notation  in  Annex  III.  The  three  interests  groups  agreed  that  biomonitoring  is 
currently the best method to assess the total exposure to MOCA in occupational settings. 
However biomonitoring can be complemented with air monitoring.  

  The three interests groups agreed an EU occupational airborne limit value for MOCA 
set at 10 µg/m3  (8hrs  TWA). Biomonitoring can be used  to  show compliance with  this 
limit value.  

58 

 
 
 
 
  The ACSH strongly recommends the Commission to adopt a skin notation preferably 
with a footnote and recital advising on the importance of biomonitoring under Directive 
2004/37/EC.  

  The  ACSH  recognizes  the  challenge  of  establishing  in  the  existing  legal  framework 
the most appropriate approach to effective risk management practice for MOCA, where 
biomonitoring is the best method for exposure assessment.  

  The BGV of 5 µmol/mol creatinine stated in the previous opinion remains appropriate. 

59 

 
 
 
 
 
 
Annex 3: Who is affected and how? 

PRACTICAL IMPLICATIONS OF THE INITIATIVE 

I. Overview of benefits (direct and indirect) – Preferred option 

Stakeholders 

Amount of costs avoided 

Description of benefits 

Workers  

Ranging  from  very  low  benefits 
for MOCA to €1 to 5 billion for 
formaldehyde  

Businesses 

Ranging  from  very  low  benefits 
for  MOCA  to  €15  million  for 
beryllium  

More  effective  protection  of  their  health, 
reducing  suffering  of  workers  and  their 
families.  Increased  length,  quality  and 
productivity  of 
lives, 
avoiding premature deaths. 

their  working 

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. 

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 
independently 
evaluate  each  carcinogen,  removing  an 
inefficiency of repetition of identical tasks. 

authorities 

to 

Administrations 

Ranging  from  very  low  benefits 
for  MOCA  to  €181  million  for 
formaldehyde 

60 

 
 
 
Stakeholders 

Workers 

Businesses 

II. Overview of costs – Preferred option 

Description of costs 

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

the  necessary 

implementation  of 

As duty holders, employers must comply with the 
whole set of OSH national legislation provisions. 
Given the nature of the proposed amendment, this 
would mainly be:  
- 
risk 
management  measures  (e.g.  substitution,  closed 
systems,  local  exhaust  ventilation,  limitation  of 
number  of  workers  exposed,  personal  protection 
equipment)  in  order  to  comply  with  the  new  or 
revised OELs  
-  implementation  of  a  sampling  strategy  and 
airborne concentrations measurement programme 
for  the  chemical  agents  with  a  new  or  revised 

Cadmium and  its 
inorganic 
compounds 

Beryllium and 
inorganic beryllium 
compounds 

Arsenic acid and 
its salts, as well as 
inorganic arsenic 
compounds 

Formaldehyde 

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

1 µg/m3 
4 µg/m3 
(7 years transition 
period) 

0.2 μg/m3 
0.6 μg/m3 
(5 years transition 
period) 

10 µg/m3 

0.37 mg/m3 

10 µg/m3 

None 

None 

None  

None  

None 

€130 million 

€21.2 million 

€1.72 billion  €701 000 

million, 
€447 
assuming 
no 
transition  period 
is established. 

61 

 
 
 
 
 
OEL,  as  part  of  the  risk  assessment  process  and 
effectiveness check of the existing measures  
-  ensure  that  the  chemical  agents  included  in 
Annex  I  will  be  managed  in  line  with  the 
provisions  of  the  carcinogens  and  mutagens 
national legislation  
-  ensure  compliance  with  other  provision  in  the 
legislation  (specific  information  and  training  to 
workers  as  regards  the  new  working  methods  if 
such is the need in order to comply with the new 
OELs,  health  surveillance,  if  appropriate,  for 
chemical  agents  now  under  the  scope  of  the 
legislation,  collection  of  records,  information  to 
competent authorities, etc.).  
Most of the listed actions are, however, business 
as usual.  

Administrations  Member  States  must  transpose  the  amended 

Limited costs 

Limited costs 

Limited costs 

Limited costs  Limited costs 

the  national  scenario  and 

Directive into national legislation:  
-  assessment  of 
potential impacts  
-  design, 
if  appropriate/needed,  of  special 
measures  (e.g.,  transitional  periods,  exemptions, 
additional provisions for specific sectors, etc.)  
- tripartite consultation of the proposal (workers, 
employers, authorities)  
- 
the  national 
implementation  of 
legislation  by  providing,  among  other  measures, 
technical guidance to employers. These costs are 
minor  in  comparison  to  the  overall  costs  of 
enforcement 
functioning 

incurred  by 

facilitate 

the 

62 

 
 
 
authorities.  
- enforce the national legislation. Introduction of 
new  OELs  in  the  CMD  would  not  have  any 
significant  impact  on  the  overall  costs  of  the 
inspection  visits.  Those  are  mostly  planned 
independently of the revised legislation. 

63 

 
 
 
Annex 4: Analytical methods used in this impact assessment 

1.  Estimations for the number of exposed workers 

Typically,  several  sources  for  the  numbers  of  exposed  workers  have  been  identified 
which, in some cases, provide very different estimates.  All these estimates are presented 
in the reports (extrapolated over the whole EU for comparison purposes).  The different 
sources  were  reviewed  to  determine  when  and  how  the  estimates  were  derived  and  the 
compounds and workforce they cover.  The most suitable estimate was then chosen for 
further modelling, taking into account (amongst others) the following factors: 

 

the  compounds  covered  by  the  estimate  (only  the  workforce  exposed  to  CMD-
relevant compounds was deemed relevant); 
the year in which the estimates were derived; 
the duration and frequency of exposure; and 

 
 
  other  factors,  e.g.  the  employment/self-employment  status  of  the  worker  (only 

employed workers within the scope of the CMD). 

2.  Impact on health 
The impacts of the different policy options were quantified, to the extent possible, based 
on the methodology as described below: 

Derivation  of  Exposure  Risk  Relationship  (ERR)  and  Dose-Response  Relationship 
(DRR) “above threshold” 

The  starting  point  for  a  cancer  risk  impact  assessment  or  a  non-cancer  health  impact 
assessment is the proposed OEL and the most recent substance evaluation by SCOEL or 
RAC. 

For an impact analysis on health consequences of elevated exposure, it is necessary: 

 
 

 

to describe the ERR for (non-genotoxic) carcinogens above threshold; 
to select the most suitable ERR for genotoxic carcinogens, if not provided by 
SCOEL or RAC; and 
to derive a DRR above threshold. 

With  an  ERR  and  DRR  derived,  it  is  possible  to  assign  an  excess  cancer  risk  to  any 
exposure  level  and  to  assign  a  fraction  of  the  exposed  which  are  expected  to  suffer  a 
(non-cancer) health effect at an elevated exposure concentration.  

Exposure Response Relationships – ERR 

For  carcinogens,  frequently  no  OELs  are  derived  if  the  carcinogen  is  regarded  a 
genotoxic  compound  without  a  threshold  for  carcinogenicity.  In  this  case,  usually  the 
classification as  a  carcinogen (according to the Classification, Labelling and Packaging  
Regulation –CLP-, IARC, or national cancer classification system) is reported.  For some 
substances,  SCOEL/RAC  also  reports  excess  risk  levels,  linked  to  various  potential 
exposure levels (e.g., 1:1,000; 1:10,000; 1:100,000 or 4:1,000 to 4:100,000).  

64 

 
 
 
 
 
 
 
Three situations may occur:  

SCOEL  or  RAC:  (1)  present  a  clear  recommendation  on  the  excess  risk  at  various 
exposure levels, (2) present various excess risk quantifications, without deciding which 
one  to  use  for  further  impact  analysis;  or  (3):  does  not  provide  information  on  excess 
cancer risk at different exposure levels.  

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). 

For  carcinogens  with  a  “practical  threshold”  (Bolt  and  Huici-Montagud,  2008)  SCOEL 
usually does not provide data on the “exposure risk relationship” or the “excess risk” to 
be assumed above threshold. If this information is not available unambiguously from the 
SCOEL/RAC document, the procedure presented above for carcinogens is followed, but 
limited to the range above the (practical) threshold (with zero excess risk at or below this 
cancer threshold). 

Dose Response Relationships – DRR 

To derive a DRR, usually the non-cancer endpoint regarded the most critical by SCOEL, 
is selected. Data from original toxicological studies, referenced by SCOEL, ECHA/RAC 
or  national  committees  as  being  qualified  and  demonstrating  a  dose-response,  are 
selected  and  searched  for  effect  levels  linked  to  a  different  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.  

However (1) different levels of “severity” are not discriminated for reasons of feasibility, 
(2)  a  change  of  the  critical  effect  at  higher  exposure  levels  (with  a  potential  different 
slope in dose response) is not considered, and similarly, (3) multiple effects occurring in 
parallel are not considered. 

Therefore,  the  DRR  does  not  cover  all  potential  adverse  effects  above  threshold  (and, 
thus, systematically underestimates impact at high exposure levels). However, increases 
in  severity,  potential  multiple  effects  or  the  change  of  the  leading  critical  toxicity 
endpoint at such high exposure levels are described qualitatively. 

With these restrictions in mind, the default approach is applied as follows: 

The selected OEL (mostly from SCOEL) is used to define a zero response, i.e., 0 % of 
the exposed are assumed to suffer from the respective health effect, if exposed for all of 
their working life time to this OEL-air-concentration. 

A three times higher concentration (3 x OEL) is usually assumed to correspond to a 10% 
incidence. This factor 3 is taken from the usual “LOAEC to NOAEC” – default and the 
corresponding increased incidence of affected persons.  

Further extrapolations to higher concentrations are avoided, if not supported by substance 
specific data. Substance specific data are preferred to default approaches. 

65 

 
 
 
 
 
2. Monetisation of the health impacts 

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

  The ERRs and DRRs; 
  The numbers of workers exposed; 
  The exposure concentrations (the average concentrations [Arithmetic Mean or 

Geometric Mean] are taken as the basis for calculations); and 
  Trends in the exposed workforce and exposure concentrations. 

For some chemical agents, two scenarios were estimated: 

  A:  actual  exposure  concentrations  –  data  one  exposure  concentrations 

collected, estimated, etc.; and 

  O:  exposure  concentrations  estimated  on  the  basis  of  existing  OELs  –  this 
scenario typically assumes  that companies have achieved  concentrations at 50% 
of the national OEL. 

For  some  chemical  agents,  there  are  sufficient  data  to  show  that  companies  have 
achieved a substantially lower exposure concentration than demanded by the OELs and, 
consequently, the O scenario has not been modelled. 

Cost categories considered 

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

Table 21: BR Toolbox on social impacts 

Guidance 

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: QALYs, DALYs, HLYs,  
Monetary  approaches:  preference  based  approaches  (WTP,  WTA  ->  VOSL, 
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) 

Aspect 

Health impacts 

Source: RPA (2018) 

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

  Direct costs: These are the medical costs associated with the treatment of cancer and 
the non-medical costs that arise directly as a result of cancer. Direct medical 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.  Direct  non-medical  costs  are  expenditures  as  a  result  of  cancer  that  are  not 
involved in the direct purchasing of medical services. They include, for example, the 

66 

 
 
 
 
cost  of  transport  to  attend  appointments  (which  may  be  borne  by  patients  or  their 
relatives/friends) and costs such as additional childcare or cleaning services. 

  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. Indirect 
costs  may  be  incurred  by  the  patient  but  also  by  their  family/friends,  for  example, 
through  providing  unpaid  care.  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  costs71  of  ill  health  are  the  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. 

3. The model 

The endpoints for which the benefits (i.e. changes in the costs caused by ill health) have 
been estimated are summarised in the table below. 

Table 22: Relevant endpoints 

Chemical agent 

Cancer endpoint 

Non-cancer endpoint 

As 
Be 

Cd 
Cr(VI) 
CH2O 
MOCA 
Source: RPA (2018) 

Lung cancer 
Lung  cancer  (but  no  workers 
above threshold) 
Lung cancer 
Lung cancer 
Nasopharyngeal cancer 
Lung cancer 

Peripheral neuropathy 
Chronic  Beryllium  Disease 
(CBD) 
Increased proteinurea 
- 
Sensory irritation  
- 

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. 

71  From a welfare economic perspective. 

67 

 
 
 
 
                                                            
Table 23: Key model inputs 

Parameter 
Rx: Estimate of the risk 

or fraction of workers 
affected 

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

ExW: Exposed workforce  Number of workers exposed at different points in time 

Cx: Exposure 

concentration 

8-hr TWA that the workers are exposed to (real concentration, i.e. 
if 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 chemical 
agent  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 
model,  however,  provides  a  good  approximation  of  the  order  of  magnitude  of  the 
expected impacts and the core calculations are supported by sensitivity analysis. 

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

Table 24: Key assumptions and their consequences for the sensitivity analysis 

Explanation 

Onset of the disease 

The minimum exposure duration required to develop the endpoint 
The time required for all workers at risk to develop the endpoint 
The  modelled  exposure  duration  (the  ERRs  and  DRRs  are  for  a  40  year 
period) 
The latency with which the effect is demonstrated 
The distribution of cases over the period between MinEx and 40 years 

The effects of the disease 

Mortality rate as a result of the relevant condition 
Monetary  value  of  a  case  taking  into  account  the  direct,  indirect,  and 
intangible costs 

Parameter 

MinEx 
MaxEx 

ModEx 

Lat 

Dist 

Mortality 

Value of a case  

Source: RPA (2018) 

Model outputs: 

  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. 

Model inputs: 

Estimate of the risk or fraction of workers affected 

The estimate of the risk or fraction of workers affected: 

68 

 
 
 
 
 
 
For  cancer: an  Exposure-Risk-Relationship  (ERR)  i.e.  excess  risk  of  developing  cancer 
due to lifetime occupational exposure to a chemical agent (taken here to mean 40 years); 
and 

For  non-cancer  endpoints:  a  Dose-Response-Relationship  (DRR),  i.e.  the  proportion  of 
workers that will develop an endpoint when exposed to a certain level. 

Exposed workforce 

Several  scenarios  are  modelled  for  the  exposed  workforce.  It  is  possible  to  take  into 
account all the complexities of real life workforce changes within the framework of this 
study 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 
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  absent  from  work  due  to  illness  and 
replaced by others. 

Exposure concentrations 

Two scenarios have been modelled:  

  ACTUAL  (A)  with  data  sourced  from  literature  and  consultation  –  this  is  the  core 

scenario for cost-benefit calculations; and 

  OEL (O) where exposure concentrations are assumed to be 50% of the national OEL 

– this is used as a check of the order of magnitude of scenario (A). 

Assumptions 

The model assumes that no cases arise until the minimum exposure duration required to 
develop the endpoint (MinEx) has expired, see table below.  The default MinEx is two 
years  for  cancer,  a  standard  assumption  for  a  chronic  condition,  and  0  years  for  non-
cancer endpoints. Although data on minimum exposure periods are lacking and the data 
in  the  table  below  are  generic  estimates,  a  short  MinEx  has  been  chosen  wherever 
appropriate to the minimum exposure periods in table below have been derived using a 
precautionary approach that maximises worker protection. 

Table 25: Minimum & maximum exposure duration to develop a condition  
(MinEx&MaxEx) 

Endpoint 

Cancer 
Non-cancer endpoint default 
Renal disease 
Chronic beryllium disease 
Sensory irritation 
Peripheral neuropathy 
Source: RPA (2018) 

MinEx (years) 
2 
1 
1 
1 
1 day 
1 

69 

MaxEx (years) 
40 
2 
20 
2 
1 day 
2 

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

Cancer 

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 
40 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. 

Figure 4: Lung cancer risk – distribution over time 
Source: RPA (2018) 

Default for non-cancer endpoints - including chronic beryllium disease 

Typically,  the  fraction  affected  achieves  that  predicted  by  the  DRR  as  soon  as  MaxEx 
expires  and  remains  constant  over  the  40  year  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  and  it  is 
assumed  that  there  will  not  be  further  increases  of  non-cancer  effects  from  longer 
duration after MaxEx. 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.   

70 

 
 
 
 
 
 
 
 
Figure 5: Non-cancer endpoints – fraction affected over time 
Source: RPA (2018) 

CH2O: Sensory irritation 

An example is provided below for sensory irritation (CH2O).  The DRR only tells us that 
the fraction affected = 2% (1 day), 2% (1 year), 2% 20 years, 2% (40 years).  Workers 
may be affected after a few hours. 

Figure 6: CH2O & sensory irritation 
Source: RPA (2018) 

Cadmium: kidney disease 

Although  the  default  for  non-cancer  effects  is  2  years  and  then  a  constant  fraction  of 
workers affected until Year 40, the time typically needed for renal damage is longer than 
2 years, e.g. 20 years.  The distribution is expected to be largely linear [affected fraction 
(for 10 years of exposure) = affected fraction (for 40 years of exposure) x (10/ 20)]. 

71 

 
 
 
 
 
 
 
 
 
 
 
Figure 7: Kidney damage – fraction affected over time 
Source: RPA (2018) 

Latency 

Cancer 

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. 

40 years of exposure and 30 years of latency would translate into a 70 year assessment 
period.  However, in order for the assessment to be protective to workers (longer latency 
reduces  the  benefits  since  they  are  discounted  more  heavily)  and  to  ensure  consistency 
with previous impact assessments for the first and the second wave of new OELs under 
the CMD72 which relied on an assessment period of 60 years, a latency period of 10 years 
is used in this study. 

A 10 year assessment period means that all cases of cancer that develop on the basis of 
the  risk  over  the  40  year  period  will  be  diagnosed  and  treated73within  the  assessment 
period of 60 years.  This is shown graphically below. 

Figure 8: The assessment period 
Source: RPA (2018) 

Non-cancer endpoints 

72  These relied on a 60 year assessment period. 

http://ec.europa.eu/transparency/regdoc/rep/10102/2016/EN/SWD-2016-152-F1-EN-MAIN-PART-
1.PDF, p. 20 and http://ec.europa.eu/transparency/regdoc/rep/10102/2017/EN/SWD-2017-7-F1-EN-
MAIN-PART-1.PDF, p. 30 

73  The treatment period for cancer used in the model is five years. 

72 

 
 
 
 
 
 
 
 
                                                            
The estimated latency period for the non-cancer endpoints in this study is either 0 years 
or  2  years.  There  is  very  limited  evidence  for  latency  of  the  relevant  non-cancer 
conditions  and  these  are  study  team  assumptions  derived  for  the  purposes  of  the 
modelling for this study. 

Table 26: Latency (Lat) 

Endpoint 

Renal disease 
Chronic beryllium disease 
Sensory irritation 
Peripheral neuropathy 
Source: RPA (2018) 

Lat (years) 
0 
2 
0 
0 

The modelled exposure duration  

The ERRs and DRRs are for a 40 year period. The modelled exposure duration is thus 40 
years under the ExW-Constant scenario and 20 years under the ExW-Turnover scenario. 

Whilst  it  is  unlikely  that  a  single  worker  is  exposed  to  a  chemical  agent  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.    In  addition,  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. 

The effects of the disease 

Mortality  rate  (MoR)  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 27: Mortality rate (MoR) 

Endpoint 

Cancer - lung 
Cancer - nasopharynx 
End-stage renal disease 
Chronic beryllium disease 
Sensory irritation 
Peripheral neuropathy 
Source: RPA (2018) 

Treatment period 

MoR (years) 
80% 
47% 
40%74 
10% 
0% 
0%75 

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

74  Average for dialysis and transplant patients, see: 

http://www.lkdn.org/dialysis_life_expectency/KidneyDialysisLifeExpectancy.pdf 

75  Very  few  forms  of  peripheral  neuropathy  are  fatal,  see  https://www.ninds.nih.gov/Disorders/Patient-

Caregiver-Education/Fact-Sheets/Peripheral-Neuropathy-Fact-Sheet 

73 

 
 
 
 
 
                                                            
Endpoint 

Cancer 
Non-cancer endpoint default 
Renal disease 
Chronic beryllium disease 
Sensory irritation 

Peripheral neuropathy 
Source: RPA (2018) 

Table 28: Treatment period 

Treatment period (years) 
5 
30 
30 
30 
No treatment required in most cases but where 

treatment required modelled as 1 year 

30 

Monetary value of the relevant endpoint 

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

Table 29: Benefits framework 

Category 
Direct 

Cost 

Healthcare 

Informal care76 

Cost  for  employers  (e.g. 
insurance) 
Mortality – productivity loss 

liability 

Morbidity – lost working days 

Approach 1 WTP: Mortality 
Approach 1 WTP: Morbidity 
Approach 2 DALY: Mortality 
Approach 2 DALY: Morbidity 

Indirect 

Intangible 

Source: RPA (2018) 

Notes 
Cost  of  medical  treatment,  including 
hospitalisation, surgery, consultations, 
therapy, 
radiation 
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  to  employers  due  to  insurance 
payments and absence from work 
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   

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 and their monetisation. 

76  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.   

74 

 
 
 
 
 
                                                            
4. Benefits assessment 

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). 

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. 

Employers 

The benefits of introducing OELs have obvious benefits for workers, namely in terms of 
their health but also, indirectly, on their earnings.  Employers will also reap benefits from 
their workers 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 workers who are ill; 
reduced sick leave payments. 

There is no risk of double counting the benefits regarding productivity for employers and 
workers in the totals.  

Employers and workers –reduction of 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  off  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  EUR  5 047  is 
given  for  productivity losses  and  EUR 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).  

75 

 
 
 
 
 
 
 
 
Public sector – avoided cost of healthcare 

Cancer 

Key  data  from  Luengo-Fernandez,  et  al  (2013)  have  been  used  for  the  calculation  the 
avoided healthcare costs of illness. EUR 7 000 is used in the model as the average cost 
for “all cancers”.  

Non-cancer effects 

In  this  impact  assessment  specific  assumptions  for  chronic  beryllium  disease,  elevated 
proteinurea,  sensory  irritation  and  peripheral  neuropathy  have  been  applied,  detailed 
tables and summary tables are presented in [RPA 2017]. 

Sensitivity analysis 

Key parameters to be varied: 

  latency; 
  a third scenario is modelled within the framework of the sensitivity analysis which 
assumes  standard  turnover  rates  based  on  Eurostat  data  resulting  in  an  increase  in 
the exposed workforce and, consequently, ill health by a factor of 4.6; 

  trends over time (exposed workforce and concentrations); and 
  influence of the fact that some workers have had higher concentrations in the past 

and reduction is only over a part of the period. 

5. Cost model 

The  spreadsheet  model  calculates  the  cost  of  reducing  exposure  from  one  level  to 
another, with the resulting sums being used to plot a cost curve. The model t 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. 

Key model inputs and assumptions 

95th percentile 

All costs are calculated on the basis of compliance as the 95th percentile of the exposure 
concentrations. This reflects the fact that it is expected that companies may be asked to 
demonstrate  compliance  on  this  basis  rather  than  on  the  basis  of  the  average  of  the 
samples taken. 

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. 

Affected workers and workstations 

Each  company  size  was  assumed  to  have  an  average  number  of  workers  affected  and 
associated workstations requiring adjustment. 

76 

 
 
 
 
Table 30: Number of workers and workstations 

Number of workers affected by 

beryllium 

Number of workstations 

2 
7 
30 

1 
4 
16 

Size of company 

Small 
Medium 
Large 
Source: RPA (2018) 

Three different costs, all present values for 60 years, are calculated: TOTAL, (CAPEX + 
OPEX) CAPEX, and OPEX. 

RMMs considered 

The 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 each type of RMM, several levels that companies can achieve have been defined (see 
RPA 2017 for details).  

RMM effectiveness 

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

Table 31: Percentage reduction in exposure achieved with RMM 

Type of RMM 
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 

% reduction in exposure 
100% 
50% 
99.5% 
90% 
80% 
0% 
99.5% 
80% 
0% 
99.5% 
95% 
60% 
0% 
30% 
0% 
30% 

77 

 
 
 
 
 
Type of RMM 
No general ventilation 
Source: RPA (2018) 

RMM costs 

% reduction in exposure 
0% 

Costs have been estimated by company size band by type of RMM applied. 

Table 32: Cost of various RMMs in EUR 

Small 
2 workers exposed 
Exposed workers on 1 
machine 

Medium 
27 workers exposed 
14 machines 

Large 
75 workers 
40 machines 

CAPEX 
2017 

Life-
span 
years 

CAPEX 
2017 

Life-
span 
years 

OPEX 
(% of 
CAPEX) 

Life-
span 
years 

20 

20 

20 

20 

20 

2 

Mask: 
1 
month, 
Filter: 
1 
month 
Not 
relevan
t, 1 per 
day 

OPEX 
(% of 
CAPE
X) 

10% 

CAPEX 
2017 

350,000 
440,000 

10% 

240,000 

10% 

90,000 

10% 

240,000 

10% 

90,000 

1,000

35,000 

% 

50% 

4,000 

7,000 

Not 
relevan
t but 
CAPE
X 2017 
incurre
d every 
year 

20 

20 

20 

20 

20 

2 

Mask: 
1 
month, 
Filter: 1 
month 

Not 
relevan
t, 1 per 
day 

OPEX 
(% of 
CAPE
X) 

10% 

1,000,000 
1,700,000 

10% 

650,000 

10% 

260,000 

10% 

650,000 

20 

20 

20 

20 

10% 

10% 

10% 

10% 

10% 

260,000 

20 

10% 

1,000

100,000 

2 

1,000% 

% 

50% 

11,000 

20,000 

Not 
relevan
t but 
CAPE
X 2017 
incurre
d every 
year 

Mask: 1 
month, 
Filter: 1 
month 

Not 
relevant, 
1 per day 

50% 

Not 
relevant 
but 
CAPEX 
2017 
incurred 
every 
year 
50% 

2,000 

50% 

27,000 

50% 

75,000 

6,000 

20 

30% 

40,000 

20 

30% 

100,000 

20 

30% 

Size of 

company 

Type of RMM 

RWK: Rework 
LEV 3: Full 
enclosure 
LEV2: Partial 
enclosure 
LEV1: Open 
hood 
WE 2: 
Pressurised or 
sealed 
WE 1: Simple 
enclosed cab  
RPE 3: 
Breathing 
apparatus 
RPE2: HEPA 
filter 

25,000 
45,000 

30,000 

7,000 

30,000 

7,000 

2,600 

300 

RPE 1: Simple 
mask 

500 

OH 1: 
Organisational 
measures 
GDV 1: General 
dilution 
ventilation 
Source: RPA (2018) 

The  assumptions  on  the  effectiveness  and  suitability  individual  RMMs  are  used  to 
determine whether a specific RMM is suitable to reduce exposure in a specific sector by 

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
the required degree. If several RMMs are suitable and effective enough, the cheapest one 
is  selected.  RMMs  that  companies  already  have  in  place  are  taken  into  account  and  a 
more effective RMM is chosen. 

The total cost of reduction is then calculated as a sum of all company-level decisions. 

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 (see detailed 
tables in[RPA 2018]). 

6. 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.  

Environmental impact profiles presented as four indices for all of the six substances have 
been established, independently from changes due to OEL changes. 

  PBT-profile.  Persistency,  bioaccumulation  and  toxicity  (PBT)  are  defined 
parameters under various regulations and are an important criterion for “substances 
of very high concern” (SVHC) under REACH. 

  The  “predicted  no  effect  concentration”  (PNEC)  is  an  environmental  hazard 
indicator.    A  currently  already  existing  relevant  risk  for  the  environment  can  be 
deduced,  if  prevailing  environmental  exposure  is  close  to  the  PNEC  or  even 
exceeds 
ratio: 
“environmental  exposure/  PNEC”,  where  ratios  close  to  1  would  substantiate 
environmental concern (we did not discriminate the aquatic or soil compartment in 
detail for the purpose of this screening). 

the  PNEC.  Therefore,  we  screened 

information  on 

the 

79 

 
 
 
 
 
  Additional air emissions may be of primary concern as an entry pathway into the 
environment from industrial pathways, where workplace exposure is via aerosols/ 
dust or gases. Therefore we looked for indicators in respect to the degree emissions 
into environment from industrial processes contribute to the overall environmental 
burden (e.g., from power stations, traffic, natural sources, etc.). 

  Finally the exposure pathway: “humans via the environment” has been considered. 
If current environmental concentrations already indicate / cause  a health problem 
to  humans  (e.g.,  via  food  or  drinking  water  exposure)  without  consideration  of 
additional emissions from OEL changes, this should be acknowledged. However, 
no  formal  assessment  of  “humans  via  the  environment”  as  would  be  required 
according  to  REACH  guidance  was  performed,  because  of  the  input  variables 
would be highly speculative. 

From these four criteria we derive an attributed overall environmental weighting of the 
respective substance, with: 

  “low” relevance, where most of the criteria above do not indicate concern; 
  “moderate”  relevance,  where  some  of  the  criteria  indicate  relevant  concern,  but 

others do not; 

  “significant” relevance, if most of the criteria indicate relevant concern; and  
  “substantial” relevance, where any changes in environmental concentrations should 
be  carefully  observed,  because  the  current  status  of  the  environmental  impact  by 
that substance already indicates the need for exposure reduction, as manifest from 
all four criteria. 

7. Consultation exercise 

The  aim  of  the  consultation  activities  was  to  collect  more  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  limits  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  chemical  agents  concerned 
(both 8 hour time weighted averages and 15 minute 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 three activities: 

  questionnaires 
 
  site visits. 

telephone interviews 

Mixed  methods  were  adopted  to  ensure  that  a  large  number  of  organisations  and 
individuals  were  able  to  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. 

80 

 
 
 
 
 
Targeted Online Questionnaires  

Stakeholders were initially contacted via email with an overview of the study and a link 
to the questionnaires.  If the stakeholders preferred to answer the questionnaire in a Word 
document (so that it could be shared among several colleagues, for example), it was also 
possible to obtain these upon request. 

Four 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  cadmium 
and its organic compounds, beryllium and its inorganic compounds, inorganic arsenic 
compounds, formaldehyde and 4,4'-Methylene-bis(2-chloroaniline) (MOCA);  

  Questionnaire 2 for companies whose workers are exposed to Cr(VI) compounds from 

welding, plasma cutting and similar processes that generate fumes;  

  Questionnaire 3 for occupational health and safety experts; and  
  Questionnaire 4 for Member State authorities.  

Telephone interviews 

Both  national  experts  and  chemical  agent  experts  were  utilised  for  the  purposes  of  the 
telephone  interviews.  Telephone  interviews  were  requested  both  in  the  online 
questionnaires and via direct email and phone contact undertaken by the experts.  

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

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.  These companies were asked both within the online questionnaire 
and within the telephone interviews. 

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

Staff  attending  the  site  visits  were  selected  for  their  language  capabilities  and  their 
knowledge  of  the  chemical  agent  concerned,  enabling  more  detailed  information  to  be 
collected. 

Other consultations 

Trade unions 

184  trade  unions  were  contacted  in  order  to  inform  them  of  the  study  and  provide  the 
opportunity  to  contribute  information.    Questionnaires  with  specific  questions  were  not 

81 

 
 
 
 
drafted for trade unions as the information readily available to them is likely to vary from 
trade union to trade union. For this reason a set of basic questions were provided either 
via email or asked over the phone, and the experts carrying out the interview were able to 
ask more detailed questions in relation to the responses. 

Six  written  responses  were  received  in  response  to  the  requests.  Trade  unions 
predominantly  provided  information  at  a  more  general  level  (i.e.  not  particular  to  a 
specific  chemical  agent),  with  occasionally  more  specific  data  relating  to  a  particular 
substance. 

The  trade  unions  viewed  the  Commission’s  efforts  to  expand  the  CMD  positively,  but 
were concerned that reprotoxic substances should also be included.   

Information  was  provided  by  trade  unions  on  the  risks  arising  from  exposure  to 
carcinogens and mutagens at work.  It was stated, for example, that the risks arising from 
exposure  to  carcinogens  and  mutagens  at  work  are  not  immediately  visible,  and  that 
inconsistencies  exist  within  data  with  regard  to  cancers  recognised  as  occupational 
diseases  and  the  number  of  cancers  attributable  to  occupational  exposure,  for  example.  
More  generally,  it  was  underlined  by  the  trade  unions  that  the  quality  of  the  data  on 
occupational cancers is rather low, with EU data on cancer containing little information 
on patients’ occupations.  The point was also raised that, due to the long latency period of 
some of the associated cancers, companies where exposure has taken place are unlikely 
to be burdened by the periods of absence associated with cancer.  

With regard to the setting of OELs, it was indicated by the trade unions that clear criteria 
are needed in order to ensure greater transparency and consistency within the legislation. 

Face-to-face meetings and additional conference calls 

Two  face  to  face  meetings  were  held  with  the  International  Cadmium  Association 
(ICdA); one in Paris and one in London.  10 conference calls have also been carried out 
with the ICdA, with 11th and 12th phone calls also planned for January 2018. 

One  face-to-face  meeting  was  carried  out  with  the  Beryllium  Science  and  Technology 
Association  (BeST),  and  one  more  meeting  is  planned  for  the  22nd  of  January  2018.  
During  this  meeting  information  was  provided  on  the  different  uses,  processes,  and 
relevant sectors.  Furthermore, opinions were provided on whether or not an STEL would 
be appropriate for beryllium. 

Laboratories 

36 laboratories were also contacted to obtain sample quotes of monitoring costs for the 
chemical  agents  in  question.  Ten  responded,  with  four  able  to  provide  beneficial 
information. 

The  questionnaires  used  and  the  results  from  the  consultation  exercise  are  presented  in 
detailed tables in the RPA (2018) draft final report. 

82 

 
 
 
 
8. Review of the REACH CSRs 

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 assessed.  Since CSRs are confidential, ECHA was 
requested to extract CSRs from registration dossiers for a limited number of 19 chemical 
agents belonging to the six (groups of) chemicals subject to this report.  ECHA extracted 
all  files  attached  in  section  13  of  the  IUCLID  datasets  of  all  registrations  for  these  19 
chemical agents. In some cases, these attachments did not represent complete CSRs, but 
rather other attachments (e.g. files intended to document strictly controlled intermediates 
for  chemical  agents  registered  as  intermediates  or  only  part  A  of  the  CSR,  which 
typically only contains a statement that RMMs are implemented and communicated). The 
table below lists the chemical agents for which such attachments were extracted and the 
groups to which they belong. 

Table 33: List of chemical agents for which CSRs were requested from ECHA 

CAS No. 
101-14-4 

Group 
4,4'-methylenebis[2-chloroaniline] (MOCA) 

Chemical agent 
4,4'-methylenebis[2-
chloroaniline] 
Beryllium oxide 
Beryllium 
Cadmium carbonate 
Cadmium oxide 
Cadmium sulphide 
Cadmium 
Cadmium chloride 
Cadmium nitrate 
Cadmium hydroxide 
Lead, bullion 
Chromium trioxide 
Formaldehyde 
Gallium arsenide 

1304-56-9 
7440-41-7 
513-78-0 
1306-19-0 
1306-23-6 
7440-43-9 
10108-64-2 
10325-94-7 
21041-95-2 
97808-88-3 
1308-38-9 
50-00-0 
1303-00-0 

Diasatriselenide 

1303-36-2 

Diarsenic trioxide 

1327-53-3 

Arsenic acid 

7778-39-4 

Lead, antimonial, dross 

69029-51-2 

Flue dust, lead-refining 

69029-67-0 

Source: RPA (2018) 

Beryllium and inorganic beryllium compounds 
Beryllium and inorganic beryllium compounds 
Cadmium and inorganic cadmium compounds 
Cadmium and inorganic cadmium compounds 
Cadmium and inorganic cadmium compounds 
Cadmium and inorganic cadmium compounds 
Cadmium and inorganic cadmium compounds 
Cadmium and inorganic cadmium compounds 
Cadmium and inorganic cadmium compounds 
Cadmium and inorganic cadmium compounds 
Chromium (VI) compounds 
Formaldehyde 
Inorganic arsenic compounds including arsenic acid and its 
salts 
Inorganic arsenic compounds including arsenic acid and its 
salts 
Inorganic arsenic compounds including arsenic acid and its 
salts 
Inorganic arsenic compounds including arsenic acid and its 
salts 
Inorganic arsenic compounds including arsenic acid and its 
salts 
Inorganic arsenic compounds including arsenic acid and its 
salts 

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 

83 

 
 
 
 
complete  CSR  and  all  the  members  of  such  a  joint  submission  (MEMBER)  often  only 
attaching Part A of the CSR (see above). 

The  following  table  summarises  the  registrations  available  per  substance  differentiated 
by the registration (FULL; INT) and submission type (LEAD, MEMBER). 

Table 34: Available REACH registrations 

Chemical agent 

CAS No. 

Number of registrations 

Total  

FULL 
LEAD 

FULL 
MEMB
ER 

INT 
LEAD 

INT 
MEMB
ER 

4,4'-methylenebis[2-
chloroaniline] 
Beryllium oxide 
Beryllium 
Cadmium carbonate 
Cadmium oxide 
Cadmium sulphide 
Cadmium 
Cadmium chloride 
Cadmium nitrate 
Cadmium hydroxide 
Lead, bullion 
Chromium trioxide 
Formaldehyde 
Gallium arsenide 
Diarsenictriselenide 
Diarsenic trioxide 
Arsenic acid 
Lead, antimonial, dross 
Flue dust, lead-refining 
Total 
Source: RPA (2018) 

101-14-4 

1304-56-9 
7440-41-7 
513-78-0 
1306-19-0 
1306-23-6 
7440-43-9 
10108-64-2 
10325-94-7 
21041-95-2 
97808-88-3 
1308-38-9 
50-00-0 
1303-00-0 
1303-36-2 
1327-53-3 
7778-39-4 
69029-51-2 
69029-67-0 

Potentially confidential 

392 

18 

321 

1 

52 

With the exception of cadmium carbonate, a single FULL LEAD registration and up to 
204  FULL  MEMBER  registrations  are  available  per  substance.    This  is  in  agreement 
with  the  expectation  since  there  is  only  a  single  lead  company  per  consortium,  but 
multiple  member  companies.  In  the case  of  cadmium  carbonate,  a  company  registering 
the  substance  as  an  intermediate  under  strictly  controlled  conditions  acted  as  the  lead 
company, while all members of the joint submission registered the substance with a full 
registration  (potentially  because  they  or  their  downstream  users  use  the  substance  in 
intermediate  under  strictly  controlled  conditions). 
other  applications 
Formaldehyde represents a special case, since registrations for this substance account for 
more than half of all registrations evaluated for all 19 chemical agents (207/392, 53 %). 
Among  the  392  registrations,  there  are  some  registrations  that  are  currently  not  active: 
1 annulled, 4 revoked and 27 inactive registrations. 

than  an 

84 

 
 
 
 
 
 
Evaluation of CSRs 

While  all  19  chemical  agents  are  registered,  a  registration  may  or  may  not  contain  a 
complete CSR (as discussed above). 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. 

Further evaluation of the extracted information also suggested that there are some cases, 
where  the  LEAD  FULL  registration  did  not  contain  a  CSR,  while  MEMBER  FULL 
registrations did.  This was e.g. the case when the registration of the lead company was 
‘inactive’ (see above).  Other cases appeared to suggest that responsibilities are changing 
(e.g. a former member taking over as the lead company in a joint submission). As a result 
of these considerations, CSRs of lead and members were evaluated, whenever possible.  
However,  the  sheer  number  of  CSRs  submitted  prevented  such  evaluations  for  a  few 
chemical  agents,  most  notably  formaldehyde.    In  such  cases,  the  CSR  from  the  LEAD 
FULL  registration  was  given  preference.  In  some  cases,  different  versions  of  almost 
identical  CSRs  were  submitted  by  different  companies.  These  appeared  to  reflect  a 
different  update  status  of  the  registrations  and  the  most  recent  version  of  the  CSR  was 
evaluated.  In a single case, the entire CSR was claimed confidential by the lead company 
and could not be evaluated. In this case, available member CSRs were evaluated. 

This  evaluation  also showed that exposure of workers to  formaldehyde  was based on a 
separate  report  annexed  to  the  CSR.  This  annex  was  not  only  submitted  by  the  lead 
company,  but  also  by  many  members  of  the  joint  submission.  This  annex  formed  the 
basis of the evaluations in the case of formaldehyde.  As a consequence, the impossibility 
to evaluate all attachments submitted for formaldehyde is considered a minor issue. 

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

85 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 35: Availability of CSRs for evaluation 

CAS No. 
101-14-4 

CSR availability (justification) 
2 CSRs 

Chemical agent 
4,4'-methylenebis[2-

chloroaniline] 

Beryllium oxide 
Beryllium 
Cadmium carbonate 
Cadmium oxide 
Cadmium sulphide 
Cadmium 
Cadmium chloride 
Cadmium nitrate 
Cadmium hydroxide 
Lead, bullion 
Chromium trioxide 

1304-56-9 
7440-41-7 
513-78-0 
1306-19-0 
1306-23-6 
7440-43-9 
10108-64-2 
10325-94-7 
21041-95-2 
97808-88-3 
1308-38-9 

Formaldehyde 

50-00-0 

Gallium arsenide 
Diarsenictriselenide 
Diarsenic trioxide 
Arsenic acid 
Lead, antimonial, dross 
Flue dust, lead-refining 
Source: RPA (2018) 

1303-00-0 
1303-36-2 
1327-53-3 
7778-39-4 
69029-51-2 
69029-67-0 

No CSR (≤ 10 tonnes per annum) 
No CSR (≤ 10 tonnes per annum) 
2 CSRs 
1 CSR  
1 CSR  
1 CSR 
2 CSRs 
1 CSR  
1 CSR 
1 CSR – not evaluated  
2 CSRs (checked only for information on welding and 
associated operations)  
Many CSRs (evaluation based on Annex on worker 
exposure)  
2 CSRs 
No CSR (≤ 10 tonnes per annum) 
2 CSRs (checked for uses exempted from authorisation) 
1 CSR 
1 CSR – not evaluated 
1 CSR – not evaluated 

Available CSRs were evaluated in detail for uses of the substance, occupational exposure 
associated  with  these  uses  as  well  as  risk  management  measures  and  operational 
conditions. These data were used in the assessments of the chemicals agents documented 
in separate reports. 

A detailed discussion is available in the RPA (2018) draft final report.  

86 

 
 
 
 
Annex 5: OELs and STELs in EU Member States for the 
substances subject to this report 

Table 36: OELs for five substances / groups of substances for EU-Member States 

Formaldehyde 
[mg/m³ (ppm)]§ 

MOCA 
[mg/m³ (ppm)]§ 

0.37 (0.3) -SKIN 

0.02 (0.002) -SKIN 

Inorganic arsenic 
compounds 
including arsenic 
acid and its salts‡ 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 
0.1 (I) 

Beryllium and 
inorganic 
compounds 
[µg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

5 (I) -whetting of Be 
metals and 
alloys, SKIN 

2 (I) -other uses, 
SKIN 

Cadmium and 
inorganic 
compounds 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

0.03 (I) -

manufacture of 
batteries, 
thermic 
extraction of 
zinc, lead and 
copper, 
welding of Cd 
containing 
alloys 

0.015 (I) -other uses 
0.01 (I) 

2 (I)  

0.01 (I) 

- 

0.11 (0.01) -SKIN 

2 

0.05 

2 -except aluminium 
beryllium 
silicate 

0.1 -SKIN notation 
only for AsO3 
and As2O3 

1.0 (0.83) 

2.5 (2.0) 

- 

0.005 (0.0005) -SKIN 

Czech Republic 

0.05 -SKIN 

1 

0.1 

0.5 (0.42) -SKIN 

1 -powder and 

1 -calcium arsenate 

0.4 (0.3) 

0.11 (0.01) -SKIN 

2 -SKIN 

0.01 -SKIN 

3.0 (2.0) -SKIN 

- 

- 

0.05 (T) 

2  

0.002 (R) 
0.05 

0.03 (R) -CdS and 

CdS pigments 

0.025 -CdF2, CdO, 
CdCl2 
0.05 (T) -metal 

powder and 
fumes, SKIN 

0.005 –powder, 
dust, and 
smoke+ 

0.01 (I) 
0.004 (R) 
0.05 (I) + 
1.0 µg/m3 (I) –only 
for non-carcinogenic 
effects 

1.6 µg/m3 (I) -
“tolerable risk” * 

0.16 µg/m3 (R) -
“acceptable 
risk” 

0.025 

0.05 -CdF2, CdCl2, 

CdO 

0.015 -except CdF2, 
CdCl2, CdO+ 

compounds, 
SKIN  

0.1 (I) -SKIN 

2 (I) -SKIN 

0.14 (I) –except 
aluminium 
beryllium 
silicate 

0.06 (R) –except 
aluminium 
beryllium 
silicate 

0.01 (T) -other 

inorganic As 
compounds 

0.03  

0.01 (I) + 

+ 

0.2 -As2O3
8.3 µg/m3 (I) -
“tolerable risk”* 

0.83 µg/m3 (I) -

“acceptable risk” 

0.6 (0.5) 

- 

0.37 (0.3) 

0.6 (0.5) 

0.37 (0.3) 

0.11 (0.01) -SKIN 

0.22 (0.2) -SKIN 

- 

5 

2  

0.1 

2.5 (2.0) 

0.22 (0.2) -SKIN 

0.03 -As2O5, SKIN 

0.6 (0.5) -SKIN 

- 

0.1 -As2O3, SKIN 

0.01 -other inorganic 

87 

Member State  
/ compound 

Austria 

Belgium 

Bulgaria 

Croatia** 

Cyprus 

Denmark 

Estonia 

Finland** 
France§§ 

Germany 

Greece 

Hungary 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Member State  
/ compound 

Cadmium and 
inorganic 
compounds 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

Beryllium and 
inorganic 
compounds 
[µg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

Inorganic arsenic 
compounds 
including arsenic 
acid and its salts‡ 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

As compounds, 
SKIN 

Formaldehyde 
[mg/m³ (ppm)]§ 

MOCA 
[mg/m³ (ppm)]§ 

0.03 (R) -CdS and 

0.2 -SKIN+ 

0.01 (T)  

0.24 (0.2) + 

0.005 (0.0005) -SKIN 

Ireland 

Italy 
Latvia 

Lithuania 

Luxembourg 
Malta 

Netherlands 

Poland 

Portugal** 

Romania 

Slovakia 

Slovenia 

CdS pigments 

0.01 (T) -except 

CdO fume and 
CdS pigments 

0.025 (R) –CdO 

0.002 (R) -except 

CdO fume and 
CdS pigments 

- 

0.01 

0.05 (I)  

0.01 (R)  
- 

- 

0.005 (R) -CdO, 
+ 
CdS,CdCl2

0.01 (I) 

0.002 (R) 

0.01 (I) 

0.002 (R) 
0.05 

2 

0.15 (I)-others 

5 (I) -refers to 

0.03 (I) -production 

of batteries, 
production of 
zinc, lead and 
copper after 
heat treatment, 
welding of 
cadmium-
alloyed metals 

0.03 (I) -production 

of batteries, 
production of 
zinc, lead and 
copper after 
heat treatment, 
welding of 
cadmium-
alloyed metals 

0.015 (I) -other uses 

whetting of Be 
metals and 
alloys, except 
aluminium 
beryllium 
silicate 

2 (I) –refers to other 

uses, except 
aluminium 
beryllium 
silicate 

5 (I) –refers to 
grinding, 
except 
aluminium 
beryllium 
silicate 

2 (I) –refers to other 

uses, except 
aluminium 
beryllium 
silicate 

- 

1 (I) 

2 (I)  

- 

- 

- 

0.2 (I) 

- 
0.01 + 

0.03  

- 

- 

0.0028  
[Excess cancer risk: 
4 x 10-4 – 0.0028 
mg/m3]2 

0.01 (I)  

0.05 (I) -SKIN 

0.01 

- 

0.5 (0.42) 

0.6 (0.5) 

- 

- 

- 

- 

- 

- 

- 

0.15 (0.12) 

0.02 (0.002) -SKIN 

0.5 (0.42) -SKIN 

0.02 (0.002) -SKIN 

[0.37 (0.3)] – 
intended 
change~ 

0.37 (0.3) 

0.11 (0.01) -SKIN 

0.01 

0.1 (I) 

1.2 (1.0) 

0.22 (0.2) -SKIN 

0.37 (0.3) -SKIN 

0.02 (0.002) -SKIN 

0.1 (I) -H3AsO4 plus 

0.62 (0.5) -SKIN 

0.02 (0.002) -SKIN 

salts 

Spain 

0.01 (I) 

0.2 (I) 

0.01 (T)  

- 

0.1 (0.01) 

88 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Member State  
/ compound 

Cadmium and 
inorganic 
compounds 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

Beryllium and 
inorganic 
compounds 
[µg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

Inorganic arsenic 
compounds 
including arsenic 
acid and its salts‡ 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

Formaldehyde 
[mg/m³ (ppm)]§ 

MOCA 
[mg/m³ (ppm)]§ 

Sweden 

United 
Kingdom  

0.002 (R) 
0.02 (T)  

0.002 (R)  
0.025 -except CdS 
pigments, 
SKIN+ 

0.03 -CdS and CdS 
pigments, 
SKIN+ 

2 (T)  

0.01 (T)  

0.37 (0.3) -SKIN 

### 

2 -SKIN 

0.1 (T) -SKIN 

2.5 (2.0) -SKIN 

0.005 (0.0005) -SKIN 

‡ inorganic arsenic compounds including arsenic acid and its salts, arsine exempted, for all occupations, as As, if not stated 
otherwise in this column. 
+ Contradictory data from questionnaire responses or GESTIS. 
- not established/assigned 
~ Intended change not implemented, yet. 
§ Unit transformation according to specific country rounding or for formaldehyde according to 1 ppm = 1.2 mg/m³; 1 mg/m³ 
= 0.83 ppm and for MOCA according to 1 ppm = 10.9 mg/m³; 1 mg/m³ = 0.09 ppm. 
SKIN: Skin notation assigned. 

** Limit values are indicative. 
§§ Limit values are recognised values with an indicative character – not according to decree modified on 30 June 2004 – 

thus not legally binding. 

* In Germany, this concentration is not regarded as a fixed OEL (AGS; TRGS 910; 

https://www.baua.de/DE/Angebote/Rechtstexte-und-Technische-Regeln/Regelwerk/TRGS/pdf/TRGS-
910.pdf?__blob=publicationFile&v=4), but as an upper limit, i.e. “tolerable risk level”: usually 4:1000 excess risk. 
However, exposures below the “tolerable risk level” but above the “acceptable risk level” need to be minimised in 
order to avoid cancer risk. 

### Handling of MOCA requires authorisation from the Swedish Work Environment Authority. 

1: IFA (2017) Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung. GESTIS - Internationale Grenzwerte 

für chemische Substanzen. 

2: HCN (2012) Health-Based Calculated Occupational Cancer Risk Values. Arsenic and inorganic arsenic compounds. 

Publication no. 2012/32. 

Source: RPA (2018) 

Table 37: Short-term Exposure Limits (STELs) for five substances / groups of substances 

Member State  
/ compound 

Austria 

Cadmium and 
inorganic 
compounds 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

0.12 (I) -battery 
production, zinc-, 
lead- or copper 
winning, welding 
of cadmium 

for EU Member States 

Beryllium and 
inorganic 
compounds 
[µg/m³]  
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

Inorganic arsenic 
compounds 
including arsenic 
acid and its salts 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

20 (I) -wetting of Be 
metals and alloys, 
SKIN 

0.4 (I) 

8 (I) other uses, 

Formaldehyde 
[mg/m³ (ppm)]§ 

MOCA 
[mg/m³ 
(ppm)]§ 

0.74 ( 0.6) -15 
min, SKIN 

0.08 (0.007) -
15 min, 
SKIN 

89 

 
 
 
 
 
 
 
 
 
 
Member State  
/ compound 

Belgium 

Bulgaria 
Croatia** 
Cyprus 

Cadmium and 
inorganic 
compounds 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

Beryllium and 
inorganic 
compounds 
[µg/m³]  
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

containing alloys  

SKIN 

0.06 (I) -other 
uses 
- 

10 (I) -SKIN 

- 

0.05 -CdO 

- 

- 

- 

- 

Inorganic arsenic 
compounds 
including arsenic 
acid and its salts 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

- 

- 

- 

- 

Czech Republic 

0.1 -ceiling 

2 -ceiling 

0.4 -ceiling 

Denmark 

Estonia 

Finland** 

France 

Germany 

Greece 

Hungary 

Ireland 

Italy 
Latvia 
Lithuania 
Luxembourg 
Malta 

Netherlands 

Poland 

Portugal** 
Romania 

Slovakia 

Slovenia 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.04 -15 min 

- 

- 

- 

- 

- 

- 

0.1 

- 

0.4 (I) -H3AsO4 plus 

salts 

- 

- 

- 

0.05 -CdO, fume 
or respirable dust 
0.008 (I) 

0.1 

- 

0.05 (R) -CdO, 
fume or 
respirable dust 
- 

0.05 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

4 (I) -15 min, SKIN 

2  

0.14 (I) -except 
aluminium 
beryllium silicate 

0.06 (R) -except 
aluminium 
beryllium silicate 
- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.12 (I) -
production of 
batteries, 
production of 
zinc, lead and 
copper after heat 
treatment, 
welding of 
cadmium-alloyed 

20 (I) –refers to 
grinding, except 
aluminium 
beryllium silicate 

8 (I) –refers to other 
uses, except 
aluminium 
beryllium silicate 

90 

Formaldehyde 
[mg/m³ (ppm)]§ 

MOCA 
[mg/m³ 
(ppm)]§ 

0.38 (0.3) –
momentary, 15 
min 
2.0 (1.7) 

2.5 (2.0) 

- 

1.0 (0.8) –ceiling, 
SKIN 
0.4 (0.3) -ceiling 

1.2 (1.0) –ceiling, 
15 min 
1.2 (1.0) –ceiling, 
15 min 
1.2 (1.0)  

0.74 (0.6) -15 
min 

2.5 ( 2.0) 

0.6 (0.5) -15 min, 
SKIN 
0.5 (0.4) -15 min 

- 

- 

1.2 (1.0) -ceiling 

- 

- 

0.5 (0.42) -15 
min 
1.0 (0.8) -15 min, 
SKIN 

0.74 (0.6) -
intended change~ 
- 

3.0 (2.0) 

0.74 (0.6) -15 
min, SKIN 
0.62 (0.5) -SKIN 

- 

- 

- 

- 

- 

- + 
- + 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

0.08 (0.007) -

SKIN 

 
 
 
 
 
 
Member State  
/ compound 

Cadmium and 
inorganic 
compounds 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

metals) 

0.06 (I) -other 
uses 

Beryllium and 
inorganic 
compounds 
[µg/m³]  
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

Inorganic arsenic 
compounds 
including arsenic 
acid and its salts 
[mg/m³] 
I=inhalable; 
R=respirable; 
T=total dust - 
fraction 

Formaldehyde 
[mg/m³ (ppm)]§ 

MOCA 
[mg/m³ 
(ppm)]§ 

Spain 

Sweden 

- 

- 

United Kingdom  

0.05 -CdO fume, 
SKIN 

- 

- 

- 

- 

- 

- 

0.37 (0.3) 

0.74 ( 0.6) -
15min, SKIN 
2.5 (2.0) -15 min, 
SKIN 

- 

- 

- 

+ Contradictory data from questionnaire responses or GESTIS. 
- not established/assigned 
~ Intended change not implemented, yet. 
§ Unit transformation according to specific country rounding or for formaldehyde according to 1 ppm = 1.2 mg/m³; 1 
mg/m³ = 0.83 ppm and for MOCA according to 1 ppm = 10.9 mg/m³; 1 mg/m³ = 0.09 ppm. 
SKIN: Skin notation assigned. 

**Limit values are indicative. 
§§ Limit values are recognised values with an indicative character  – not according to decree modified on 30 June 

2004 – thus not legally binding. 

† Official Japanese values could not be identified. Therefore, recommendations from the Japan Society for 
Recommendation of Occupational Exposure Limits (JSOH), which are not mandatory, are stated. 

References: 
Questionnaire information (this project) or GESTIS (IFA, 2017), or country specific lists of OEL from web-search. 
Source: RPA (2018) 

91 

 
 
 
 
 
 
 
 
Table 39(a): Member States with OELs higher than the proposed levels 

Cadmium and its inorganic compounds under the scope of the CMD 

MS with OELs higher than the proposed levels for Cadmium and its inorganic compounds 
OEL 
µg/m³ 

Member States where current limits 
are higher 

Notes regarding national limits 

% of MSs 
above 
reference 
OELV 
80% 

1 

4 

5 

10 

25 

AT, BE, BG, HR, CY, CZ, DE, DK, 
EE, FI, FR, DE, EL, HU, IE, LV, LT, 
NL, PL, SI, ES, SE, UK 
AT, BE, BG, HR, CY, CZ, DK, EE, 
FI, FR, EL?, HU, IE, LV, LT, NL, PL, 
SI, ES, SE, UK 
AT, BE, BG, HR, CY, CZ, DK?, FI, 
FR, EL?, HU, IE, LV, LT, NL, PL?, 
SI, ES?, SE, UK 

75% 

70% 

AT, BG, HR, CY, CZ, DK?, FR, HU, 
IE, LV, LT, NL, SI, SE, UK 

55% 

AT, BG, HR, CY, CZ, FR, HU?, IE, 
LT?, SI, SE, UK? 

45% 

DE: Excess cancer risk (I): 
2.5 x 10-3 (1.6 µg/m3;“tolerable risk”) 

BE: 5 µg/m3 but not clear for what. 
EL: limit of 2.5 µg/m3 but unclear if 
(I) or (R). If R, equiv. I is 6.25 µg/m3 
DK: limit of 5 µg/m3 but unclear if (I) 
or (R). If R, equiv. I is 12.5 µg/m3 
EL: As above 
PL: 10 µg/m3 based on (I) value and 5 
µg/m3  based on (R) value 
ES: 10 µg/m3 based on (I) value and 5 
µg/m3  based on (R) value 
AT: 15 µg/m3 for welding of Cd 
containing alloys, other uses 
DK: as above 
FI: 10 µg/m3 limit is indicative 
LV: limit of 10 µg/m3 but unclear if 
(I) or (R). If R, equiv. I is 25 µg/m3 
AT: 30 µg/m3 for manufacture of 
batteries, thermic extraction of zinc, 
lead and copper 
HR: 75 µg/m3 for CdS and pigments 
(indicative). Limit of 25 µg/m3 covers 
Cd F, Cd O, Cd Cl 
HU: limit of 15 µg/m3 but unclear if 
(I) or (R). If R, equiv. I is 37.5 µg/m3 
IE: limit of 62.5 µg/m3 for “except 
CdO fume and CdS pigments”. Other 
limits at 25 and 5 µg/m3 
LT: 50 µg/m3 based on (I) value and 
25 µg/m3  based on (R) value 
UK: limits of 25 µg/m3 and 30 µg/m3 
but unclear if (I) or (R). If R, equiv. I 
values are 62.5 µg/m3 and 75 µg/m3 

(I) = inhalable, (R) = respirable (T) = total dust 

CY has limit of 50 µg/m3 (T) Included in all OEL categories 
EE also has limit of 50  µg/m3 (T) Included in all OEL categories 
SE also has limit of 5 µg/m3 (T) Already included for (I) values 

92 

 
 
 
 
 
 
Beryllium and inorganic beryllium compounds 

MS with OELs higher than proposed levels 
OEL 
µg/m³ 
0.02 

Member States where current limits are higher 

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

AT, BE, BG, HR, CY, CZ, DK, EE, FR, EL, HU, LV, 
LT, RO, SK, SI, SE, UK 
AT, BE, BG, HR, CY, CZ, DK, EE, FR, EL, HU, LV, 
LT, RO, SK, SI, SE, UK 
AT, BE, BG, HR, CY, CZ, DK, EE, FR, EL, HU, LV, 
LT, RO, SK, SI, SE, UK 
AT, BE, BG, HR, CY, DK*, EE, FR, EL, HU, LT, RO, 
SK, SI, SE, UK 
AT*, HR*, EL, SK*, SI* 

0.05 

0.1 

0.2 

0.35 

0.6 

1 

2 

Notes regarding national limits 

DE:  0.06 (R), except aluminium 
beryllium silicate; 0.14 (i) except 
aluminium beryllium silicate 

DK: Powders and compounds 

AT: Current limit of 2(i) for “other 
uses,”; 5 for “whetting of beryllium 
metals and alloys” 
HR:  Except aluminium beryllium 
silicate 
SK: 5(i), except aluminium beryllium 
silicate, whetting of beryllium metals 
and alloys; 2(i),  Except aluminium 
beryllium silicate, other uses 
SI: 5(i), except aluminium beryllium 
silicate, grinding; 2 (i), Except 
aluminium beryllium silicate, other 
uses 

Source: RPA 

i = inhalable, R = respirable  

*Indicates that MS has more than one limit, at least one of which is higher than the proposed OEL, or that 
it is not clear if all uses are covered by the limit 

93 

 
 
 
 
 
 
 
 
 
 
 
 
Arsenic acid and its salts, as well as inorganic arsenic compounds 

MS with OELs higher than assessed OELVs 
OELV 
µg/m³ 

Member States where current limits 
are higher or the MS does not have 
an OEL covering the compounds 
within the scope 

10 

25 

AT, BG, HR, CZ, EE, FR, EL, HU**, 
IT, LT, LU, MT, PT, SK, SI, UK  
AT, BG, HR, CZ, EE, FR, EL, HU**, 
IT, LT, LU, MT, PT, SK, SI, UK  
AT, HR, CZ, FR, EL, HU**, IT, LU, 
MT, PT, SK, SI***, UK 

Notes regarding national limits 

% of MS 
above 
reference 
OELV or 
without 
OEL 
57% 

57% 

50 

Hungary has separate OELs for As2O5 
and As2O3 at 30 and 100 µg/m³, 
respectively, whereas it is 10 µg/m³ 
for other inorganic arsenic compounds 
Notes: Denmark has for calcium arsenate an OEL at 1,000 µg/m³. As no intentional use of calcium arsenate 
in Denmark has been identified it is estimated that establishing an OEL at the assessed levels in Denmark 
would not have any impact. 

46% 

Formaldehyde 

Table 8-38:  MS with OELs higher than proposed levels 
Member States where current limits are higher 
OEL 
mg/m³ 
0.15 

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

0.37 

0.6 

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

Notes regarding national limits 

FR:  Intended change to 0.35 
PL:  intended change to 0.37 

Notes regarding 
national limits 

- 

- 

- 

Companies located in MS where current limits 
are higher or the MS do not have an OEL 
covering the compounds within the scope 

MS with companies using MOCA and with OELs higher than assessed levels 
% of MS with 
OELV 
companies using 
µg/m³ 
MOCA above 
reference OELV or 
without OEL 
82% 

5 

BE, DK, FR, EL, NL, PT, ES 
HU, IT 
BE, DK, FR, EL, NL, PT, ES 
HU, IT 
BE, DK, FR, EL, NL, PT, ES  
HU, IT 

10 

20 

82% 

82% 

94 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annex 6: Selection procedure for priority compounds in 
substance groups 
The  Commission  initiated  work  to  amend  or  establish  OELs  for  25  priority  chemicals 
agents  in  2004.  The  selection  was  made  on  the  basis  of  the  views  of  stakeholders,  in 
particular with MS during exchanges with the Commission, notably meetings of National 
Experts Working Group on OELs. These 25 chemical agents were considered a priority 
for  protection  of  workers  and  the  choice  is  in  line  with  subsequent  third  party  priority 
lists,  for  instance  those  put  forward  by  the  European  Trade  Unions  or  the  Netherlands 
National Institute for Public Health and the Environment.  

Further to exchange and in particular within the tripartite Advisory Committee on Safety 
and Health at Work, the five additional substances subject to this initiative were selected 
taking into account general considerations such as the following: 

  The  potential  to  cause  adverse  health  effects  resulting  from  occupational 

exposure. 

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

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

  Degree of evidence for adverse effects.  

  Characteristics  of  the  adverse  effects  (severity,  potency,  reversibility, 

specificity).  

  Estimated number of workers exposed.   

 

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

  Policy  considerations,  such  as  problematic  disparities  with  or  between  other 

relevant threshold values, degree. 

In particular, as regards three of the substances, refined prioritisation was needed in order 
to  identify  compounds  that  fall  under  the  scope  of  the  CMD.  The  following  elements 
have been considered for such selection as regards each of them. 

Cadmium and its inorganic compounds 

Criteria for the determination of the relevant compounds 

The following screening criteria have been applied to select the cadmium compounds:  

  Does the compound pass the initial test of relevant (not an erroneous entry, not 

 

a reaction mass, not a UVCB77)? 
Is there a CLH 1A or 1B for the compound? If the compound only has a self-
classification as Carc. 1A or 1B, is the compound also registered?  

  Where  compounds  also  contain  another  carcinogen,  is  cadmium  clearly  the 

driver of the carcinogenic potency or the “mode of action” (MoA)? 

77  Substance of Unknown or Variable composition, Complex reaction products or Biological materials 

95 

 
 
                                                            
 
 

Is there any another reason for excluding any of the compounds, e.g. compound 
too far removed from the definition? 

Final selection 

The relevant substances following the screening process are summarised below. 

Table 39: Cadmium – screening process 

Step 

Number of compounds 

Total number of Cd compounds identified 

Of  which,  pass  the  first  test  of  relevance  (not 
clearly  erroneous,  not  a  reaction  mass,  not  a 
UVCB, etc.) 

Of  which,  compounds  with  CLH  Carc.  1A  or 
1B  or  self-classified  as  Carc.  1A  or  1B  and 
registered 

Of which, Cd driver of carcinogenic potency or 
the mode of action 

Source: RPA (2018) 

364 

120 

16 

11 

The relevant compounds to be assessed in the study are summarised below. 

Table 40: Cadmium and inorganic Cd compounds – final selection 

Compound 

CAS No. 

Cadmium oxide 
Cadmium sulphide 
Cadmium 
Cadmium fluoride 
Cadmium chloride 
Cadmium sulphate 
Cadmium nitrate 
Cadmium hydroxide 
Cadmium carbonate 
Cadmium sulfate hydrate 
Cadmium(2+) ion bis(nitric acid) 
Source: RPA (2018) 

1306-19-0  
1306-23-6  
7440-43-9  
7790-79-6  
10108-64-2, 35658-65-2  
7790-84-3, 10124-36-4, 31119-53-6  
10022-68-1, 10325-94-7  
21041-95-2  
513-78-0  
15244-35-6 
10022-68-1 

Arsenic acid and its salts under the scope of the CMD 

Criteria for the determination of the relevant compounds 

The following screening criteria have been applied to select the arsenic compounds that 
were prioritised:  

96 

 
 
 
 
a)  Is  there  a  harmonised  classification  as  Carc.  1A  or  1B  for  the  compound?  We 
have assumed that in line with the ‘arsenic acid and its salts not listed elsewhere 
in this annex’ all arsenic acid salts are CLH Carc. 1A but have checked this for all 
the other arsenic compounds. 

b)  If the compound only has a self-classification as Carc. 1A or 1B, is the compound 
also  registered?  We  have  assumed  that  more  reliable  data/information  will  be 
available for registered compounds. 

c)  Does  the  compound  fit  the  definitions  ‘arsenic  acid  and  its  salts’  or  ‘inorganic 

arsenic compound? 

d)  Where compounds also contain another carcinogen element: Is As the component 

driving carcinogenic potency or Mode of Action (MoA)?78 

e)  Is there any another reason for excluding any of the compounds? For example, we 

have excluded salts from arsine or complex compounds. 

The relevant substances following the screening process are summarised below. 

Table 41: As – screening process 

Step 
Total number of As compounds 
Of  which,  compounds  with  harmonised 
classification  as  Carc.  1A  or  self-classified  as 
Carc. 1A and registered 
Of which, inorganic arsenic compounds  
Of which, As driver of carcinogenic potency or 
the mode of action 
Source: RPA (2018) 

Number of compounds 
164 
11+46 

53 
31 

The relevant compounds assessed are summarised below. 

Table 42: Inorganic arsenic compounds – final selection 

Compound 
Diarsenic pentaoxide 
Diarsenic trioxide 
Arsenic acid, sodium salt 
Arsenic acid 
Disodium hydrogenarsenate 
Calcium arsenate 
Arsenic trichloride 
Potassium dihydrogenarsenate 
Diammonium hydrogenarsenate 
Sodium dioxoarsenate 

CAS No. 
1303-28-2, 12044-50-7 
1327-53-3, 7440-38-2 
7631-89-2 
7778-39-4 
7778-43-0 
7778-44-1 
7784-34-1 
7784-41-0 
7784-44-3 
7784-46-5 

78  The compounds that will be considered are those where arsenic is clearly the driver of the carcinogenic 
potency  or  the  “mode  of  action”  (MoA).  Existing  OEL  and  cancer  risk  quantifications  from 
SCOEL/RAC  do  not  cover  arsenic  compounds  with  other  MoA  and  potency.  Therefore,  the  impact 
assessment is preferably to be linked to this demarcation criterion. 

97 

 
 
 
                                                            
Compound 
Iron arsenate 
Iron bis(arsenate) 
Arsenic acid, magnesium salt 
Arsenic acid, copper salt 
Arsenic acid, calcium salt 
Ammonium dihydrogenarsenate 
Trisodium arsenate 
Zinc arsenate 
Sodium metaarsenate 
Triammonium arsenate 
3-methyl-4-(pyrrolidin-1-
yl)benzenediazoniumhexafluoroarsenate 
Arsenic acid, copper(2+) salt 
Vanadium(4+) diarsenate (1:1) 
Sodium hexafluoroarsenate(V) 
Calcium hydrogen arsenate 
Sodium arsenate dibasic heptahydrate 
Source: RPA (2018) 

CAS No. 
10102-49-5 
10102-50-8 
10103-50-1 
10103-61-4 
10103-62-5 
13462-93-6 
13464-38-5 
13464-44-3 
15120-17-9 
24719-13-9 
27569-09-1 

29871-13-4 
99035-51-5 
12005-86-6 
15195-00-3 
10048-95-0 

Beryllium and its inorganic compounds 

The beryllium compounds were screened as described below  

Table 43: Beryllium – screening process 

Step 
Total number of beryllium compounds 
Of  which,  compounds  that  are  also  self-
classified 
Of  which,  inorganic  beryllium  compounds  (or 
Be) 
Source: RPA (2018) 

Number of compounds 
66+beryllium silicates 
12 

9 

The relevant compounds assessed are summarised in the table below: two are definitely 
considered (shown in bold) and seven could potentially be relevant. 

Table 44: Beryllium and inorganic beryllium compounds – final selection 

Compound 
Beryllium oxide 
Beryllium 
Beryllium chloride 
Beryllium fluoride 
Beryllium sulphate 
Beryllium nitrate 

CAS No. 

1304-56-9 
7440-41-7 
7787-47-5 
7787-49-7 
13510-49-1 
13597-99-4 

98 

 
 
 
Compound 
Disodium tetrafluoroberyllate 
Beryllium(2+) ion tetrahydratedinitrate 
1000 mg/L Beryllium 
Source: RPA (2018) 

CAS No. 

13871-27-7 
13510-48-0 
- 

In this assessment two compounds were ever considered: beryllium and beryllium oxide.  
Copper, aluminium, magnesium and nickel are widely alloyed with beryllium. These are 
a cause of worker exposure and are included in the assessment. Approximately 80% of 
all beryllium in EU is used in copper beryllium alloy (CuBe.)  

99 

 
 
 
 
Annex 7: Relevant sectors, uses and activities and estimations 
of EU workers exposed 

Cadmium and its inorganic compounds 

Cadmium 

Cadmium is a rare element not found in its pure state in nature.  Instead, it occurs mainly 
as  cadmium  sulphide  (or  ‘greenockite’)  in  deposits  of  zinc  (National  Toxicology 
Program, 2014).79 

Today, most cadmium metal is produced as a by-product of the extraction, smelting and 
refining  of  zinc,  lead  and  copper.  In  addition,  cadmium  is  also  produced  from  the 
recycling of spent nickel-cadmium batteries (its largest use), and secondary or recycled 
cadmium  now  accounts  for  about  23%  of  total  cadmium  supply  (ICdA,  2016).80  
Cadmium is commercially available in purities ranging from 99 - 99.9999%, as powders, 
foils, ingots, slabs, sticks and crystals (National Toxicology Program, 2014). 

Information  on  cadmium  uses,  as  identified  by  the  Cd  REACH  Consortium  (2012a)  is 
provided in the following figure81. 

Figure 9: Initial overview of cadmium uses 
Source: Cd REACH Consortium (2012a) 

Cadmium alloys 
The widespread use of cadmium in such alloys is of importance to a number of sectors82.  
For  example,  AIA  in  ECHA  (2013b)83  highlights  the  use  of  cadmium  as  an  alloying 

79  US  National  Toxicology  Program.  (2014).  Report  on  Carcinogens  (13th  Edition),  from 

https://ntp.niehs.nih.gov/ntp/roc/content/profiles/cadmium.pdf 
ICdA. (2016). Cadmium - Introduction, from http://www.cadmium.org/introduction 

80 
81  Cd  REACH  Consortium.  (2012a).  Cadmium  -  Identification  of  Uses,  from  http://www.reach-

82 

cadmium.eu/substance-information-exchange-forum/substance-uses/cadmium-2311528 
International  Cadmium  Association.  (undated).  Cadmium 
Association. 
July 
applications/cadmium-in-alloys 

in  Alloys.International  Cadmium 
http://www.cadmium.org/cadmium-

Retrieved 

2016, 

from 

29, 

100 

 
 
 
                                                            
element  in  copper,  tin,  and  zinc  alloys  used  in  the  aerospace  industry.    In  the  same 
document  the  UK  ADS  notes  that  silver  electric  contacts  (silver-cadmium  oxide) 
incorporating 10 to 15% cadmium are useful in many heavy duty electrical applications 
such  as  relays,  switches,  circuit  breakers  and  thermostats  in  the  aerospace  and  defence 
sector.    The  presence  of  cadmium  improves  resistance  to  material  transfer  and  electric 
erosion.  

Cadmium chloride 

Cadmium chloride is produced by reaction of molten cadmium and chlorine gas at 600 
°C  or  by  dissolving  cadmium  metal  or  the  oxide  in  hydrochloric  acid,  subsequently 
vaporising the solution (Pubchem, undated).84 
ICdA  in  ECHA  (2014a)85  provides  more  specific  information,  noting  that  the  reported 
manufactured (or imported) tonnage of cadmium chloride in the EU fluctuates from year 
to year, depending on the demand of photovoltaic panels but is in the range of 5-8 t/y. 

As  well  as  photovoltaic  applications,  the  Cd  REACH  consortium  highlights  that 
following uses of relevance associated with the substance86: 

  Component for production of organic and inorganic cadmium compounds; 
  Electro-galvanizing; 
  Electroplating; and 
  Chemical reagent. 

Cadmium fluoride 

ICdA in ECHA (2014b) notes that the compound is probably limited to minor laboratory 
reagent uses87.  

Cadmium sulphate 

Anhydrous  cadmium  sulphate  is  prepared  by  oxidation  of  the  sulphide  or  sulphite  at 
elevated  temperatures,  or  by  the  action  of  dimethyl  sulphate  on  finely  powdered 
cadmium  nitrate,  halides,  oxide  or  carbonate.    Solutions  are  prepared  by  dissolving 
cadmium  metal,  oxide,  sulphide,  hydroxide  or  carbonate  in  sulfuric  acid.    Anhydrous 
cadmium  sulphate  is  also  produced  by  melting  cadmium  with  ammonium  or  sodium 
peroxodisulphate.  Cadmium sulphate monohydrate, which is the form usually marketed, 
is produced by evaporating a cadmium sulphate solution above 41.5 °C 

Despite  the  intermediate  only  registration,  available  literature  does  suggest  that  the 
compound  may  have  a  wider  scale  of  uses  to  consider.  For  example,  Rajadurai  et  al. 

83 

84 

85 

86 

87 

(undated). 

Compound 

ECHA. (2013b). Comments on an Annex XV dossier for indentification of a substance as SVHC and 
responses  to  those  comments  -  Cadmium.fromhttps://echa.europa.eu/documents/10162/9731cc85-
9740-47ac-a489-0142f38a6956 
Pubchem. 
https://pubchem.ncbi.nlm.nih.gov/compound/Cadmium_dichloride#section=Top 
ECHA.(2014a). Comments on an Annex XV dossier for indentification of a substance as SVHC and 
responses to thse comments - Cadmium chloride. 
See http://www.reach-cadmium.eu/substance-information-exchange-forum/substance-uses/cadmium-
chloride-2332967.  
ECHA. (2014b). Comments on an Annex XV dossier for indentification of a substance as SVHC and 
responses to thse comments - Cadmium fluoride, from 
https://echa.europa.eu/documents/10162/6f01fd3c-e0e6-4f19-be18-855ad6851eb3 

summary 

cadmium 

chloride, 

from 

for 

101 

 
 
                                                                                                                                                                                 
(2013)88 highlights that cadmium sulphate is an important inorganic cadmium compound 
which  is  widely  used  in  semiconductor  industry  with  many  excellent  physical  and 
chemical properties.  

Cadmium sulphide 

Cadmium  sulphide  (CdS)  can  be  manufactured  by  passing  hydrogen  sulphide  gas  into 
cadmium chloride solution (CdCl2 + H2S = CdS↓ + 2HCL).  Another method is to acidify 
a solution of cadmium sulphate with hydrochloric acid and to add a freshly made solution 
of  sodium  sulphide  (CdSO4  +  NA2S  =  CdS↓  +  NA2SO4)  (NIIR  Board,  2003)89.  
Information within the Candidate List ‘Response to Comments’ (RCOM) document for 
the compound90 suggests it is used mainly for the manufacture of photovoltaic panels and 
as an intermediate in the manufacture of other cadmium compounds, including pigments.  
It is also used in small quantities as intermediate in glass colouration. 
Uses as identified by the Cd REACH Consortium91 have been listed below: 

  Component for production of inorganic cadmium compounds; 
  Laboratory reagent; 
  Cadmium production by pyrometallurgy; 
  Component for production of organic cadmium compounds; 
  Component for production of inorganic pigments; 
  Additive for production of frits; 
  Additive for production of glass; 
  Additive in the manufacturing of electronic components; 
  Use of CdS-containing catalysts; and 
  Component for production of PV modules. 

Cadmium oxide 

The  figure  below  presents  a  flow  diagram  for  the  production  of  cadmium  oxide  which 
includes  the  fusion  of  metal  ingots  at  temperatures  higher  than  320°C,  followed  by 
oxidation  on  contact  with  air  to  produce  cadmium  oxide  in  a  powder  form  which  is 
subsequently collected in bag filters. 

88  Rajadurai, G., Puhal Raj, A., &Pari, S. (2013). Growth and characterization of cadmium sulphate 

single crystal by gel growth. Archives of Applied Science Research, 5(3), 247-253, from 
http://scholarsresearchlibrary.com/aasr-vol5-iss3/AASR-2013-5-3-247-253.pdf 

89  NIIR Board. (2003). The Complete Technology Book on Printing Inks. Asia Pacific Business Press. 
90 
91 

See https://echa.europa.eu/documents/10162/5f847fab-5b4d-43da-a220-53ac8280464f 
See http://www.reach-cadmium.eu/substance-information-exchange-forum/substance-uses/cadmium-
sulphide-2151478.   

102 

 
 
 
 
                                                            
Figure 10: Flow diagram for the production of Cd oxide 
Source:  Cd REACH Consortium (2012b) 

Information  on  cadmium  oxide  uses,  as  identified  by  the  Cd  REACH  Consortium  are 
provided  in  the  following  figure.  The  substance  is  one  of  the  main  precursors  to  other 
cadmium compounds. 

Figure 11: Initial overview of cadmium oxide uses 

Source: Cd REACH Consortium (2012b)92 

Cadmium carbonate 

According  to  Considine  (1995),  cadmium  carbonate  is  produced  by  the  reaction  of 
cadmium  hydroxide  and  carbon  dioxide  or  upon  precipitation  of  a  cadmium  salt  with 
ammonium carbonate.  The Cd REACH Consortium93 has identified the following uses 
of cadmium carbonate: 

92  REACH  Consortium. 

(2012b).  Cadmium  Oxide 

(215-146-2), 

from  http://www.reach-

93 

cadmium.eu/substance-information-exchange-forum/substance-uses/cadmium-oxide-2151462 
See http://www.reach-cadmium.eu/substance-information-exchange-forum/substance-uses/cadmium-
carbonate-2081689.   

103 

 
 
 
 
 
 
 
                                                            
  Lab reagent; 

  Component for production of organic/inorganic cadmium compounds and salts; 

  Component for production of inorganic pigments; 

  Additive for production of glass; 

  Component for polymer-matrices, plastics and related preparations; 

  Use of CdCO3-containing polymers for cable protecting & isolating coatings; 

  Use of CdCO3-containing polymers for tube & sheet articles; 

  Use of CdCO3-containing polymers for moulded articles; and 

  Use of CdCO3-containing catalysts. 

Cadmium hydroxide 
The Cadmium REACH Consortium94 has identified the following uses of the compound: 

  Component for production of organic and inorganic cadmium compounds; 

  Electro-galvanizing; 

  Electro-plating; 

  Laboratory reagent; 

  Cadmium production by pyrometallurgy; 

  Component for production of Inorganic pigments; and 

  Batteries/fuel cells. 

Cadmium nitrate 
The Cadmium REACH Consortium95 has identified the following uses of the compound: 

  Component for production of inorganic cadmium compounds; 

  Component for production of organic cadmium compounds; 

  Laboratory reagent; 

  Component for production of inorganic pigments; 

  Additive for production of glass; 

  Additive for production of ceramics; 

  Use of Cd(NO3)2-containing catalysts; 

  Use of Cd(NO3)2-containing photographic emulsions; and 

94 

95 

See http://www.reach-cadmium.eu/substance-information-exchange-forum/substance-uses/cadmium-
hydroxide-2441685. 
See http://www.reach-cadmium.eu/substance-information-exchange-forum/substance-uses/cadmium-
nitrate-2151462. 

104 

 
 
 
 
                                                            
  Batteries/fuel cells. 

Relevant sectors, uses and activities 

According  to  the  RPA  study,  the  sectors  and  uses  where  occupational  exposure  is 
expected to take place are summarised below. 

Table 45: Sectors and uses where occupational exposure to cadmium is expected 
Uses and/or activities 
Extraction and refining of Cd 

Notes 

Sector 
1:  Zn  &  Cu  smelting  and  Cd 
refining 
2: Speciality chemicals 

or 

chemical 
Mechanical 
transformation  of  Cd  metal  into 
specialised  compounds,  mainly 
for  the  battery,  PV  panels  and 
pigments sectors 
Production of Ni-Cd batteries 
Production of pigments 

ICdA:  Cd 
classified hazardous 
vs. 
SUMER 
sulphide 

2010: 

compounds 

not 

Cadmium 

3: Ni-Cd batteries 
4: Pigments 

5: Aerospace & defence 

Parts96,  connectors  and  fasteners 
undergo Cd surface treatment 
Brazing alloys 

7: Niche manufacturing 

6: Surface treatment contractors  Subcontracted  surface  treatment 
for  Sector  5,  includes  repair  & 
maintenance97 
PV  panels, 
infra-red 
performance contact materials 
Post-industrial  waste, 
used 
batteries,  treatment  of  ZnO  dust 
captured  in  Zn  smelters’  bag 
houses, metals 
WEEE  (shredding  of  electronic 
waste) 

temperature 
high 

low 
detectors, 

8: Recycling 

9:  Mining  of  non-ferrous  metal 
ores 

10 Metals fabrication 

A:  Exposure  at  all  stages  of 
production  processes 
(mining, 
beneficiation, haulage) 
B:  Maintenance  workers  and 
process operators 
Smelting 
refining 

foundries, 

(steel), 

96  Assumed to include landing gear. 
97 

See http://dublinaerospace.com/landing-gear/ 

105 

of 

shredding 

Exposure  to  cadmium  can  be  an 
older 
effect 
ray 
televisions,  with  cathode 
tubes,  which  are  known 
to 
contain  fluorescent  powder  that 
includes cadmium. 
CdS in ore, Cd in ore 

Cadmium is sometimes measured 
in  foundry  dust.  Cd  is  a  part  of 
the  amalgam  of  castings  alloys, 
in low concentrations. Therefore, 
exposure 
these  substances 
through  foundry  activities  is  no 
the 
source  of 
is 
companies.  The  exposure 

concern 

to 

to 

 
 
 
 
 
 
 
 
 
 
                                                            
Sector 

Uses and/or activities 

Notes 

11 Glass 
12 Cement 
13  Other  (ASA,  excl.  those 
already  mentioned  above  and 
than  20 
those  with 
exposed workers) 

fewer 

14 Other (consultation) 

Source: RPA (2018) 

below the present OELs. 
Cadmium carbonate 

Production of frit 
Cement & clinker production 
Real estate and landscaping  
Office and institutional detergents etc.;  
Agricultural and industrial machinery installers and repairers 
Laboratories  Waste  incineration  and  water  treatment  plants  process 
managers 
Electrical, gas and heat supply, cooling business 
Scientific research and development 
Architectural and engineering services; technical testing and analysis 
Public administration and defence, compulsory social insurance 
Paper, paper and board products manufacturing 
Electronics and automation equipment installers and repairers 
Office cleaners in offices, hotels and other institutions 
Pipe fitters 
Paper pulp and paper and board manufacturing process workers 
Insulators 
Welding,  
Cement 
Energy generation 
Glass 

There are a number of sectors that have been identified from consultation or the Finnish 
Register  of  Workers  Exposed  to  Carcinogens  (ASA  Register)  but  for  which  exposure 
could  not  be  corroborated  from  other  sources.    In  Finland,  employers  are  obliged  to 
provide data on the exposure of workers to certain carcinogens to the Finnish Institute of 
Occupational Health (FIOH)) so that it can be entered into the ASA register (EU-OSHA, 
2014)98:  Although this is an obligation for employers, Kauppinen et al. (2007) note that 
it is likely some do not submit data.99 

Other sectors considered by the study team but  not  included in  the table above  include 
recycling of Cd-containing rigid PVC.  Communication with EuPC suggests that the Cd 
compounds to which workers are exposed are outside the scope of the study. 

The  sectors  in  REACH  registration  CSRs  (see  below)  overlap  with  the  sectors  in  the 
table below. 

98   https://osha.europa.eu/en/tools-and-publications/publications/reports/report-soar-work-related-cancer 
99   https://academic.oup.com/annweh/article-lookup/doi/10.1093/annhyg/mem030 

106 

 
 
 
 
 
                                                            
Table 46: Sectors in REACH registration CSRs that are relevant to cadmium metal, 

cadmiumoxide, cadmiumcarbonate 

Cadmium metal production RLE 
Cadmium metal production by pyrometallurgy 
Storage of ingots-slabs in warehouses 
Production of chemicals (pyro) 
Production of chemicals (hydro) 
Additive for production of inorganic catalysts 
Melting, alloying and casting 
Production of "targets" by (EB) PVD 
Cadmium casting and rolling 
Wire and rods manufacturing 
Component for brazing products 
Component for soldering products 
Downstream use of Cadmium based brazing products 
Downstream use of cadmium-based soldering products 
Cadmium (alloyed) powder manufacturing 
Powders for contact materials 
Use of active powders for batteries 
Use of fine powders for mechanical plating 
Manufacturing of Cadmium containing-alloys 
Use of cadmium containing Ag alloys 
Electroplating 
PVD / coating 
Source: RPA (2018) 

Estimated EU workers exposed 

According  to  the  draft  final  report  of  the  external  study100  different  sources  compile 
estimates of the total number of exposed workers – which can differ by a factor of up to 
125. 

The consultant identified as the only multi-country estimate the CARcinogen EXposure 
(CAREX101,102) database, with further estimates being available for the Czech Republic, 
Finland, France, and the UK (although the data for the UK are also based on CAREX). 

The different estimates are presented in the table below. The divergence in the estimates 
is  representative  for  many  problems  confronted  with  in  the  analysis  presented  in  this 

100  Third study on collecting most recent information for a certain number of substances with the view to 
analyse  the  health,  socio-economic  and  environmental  impacts  in  connection  with  possible 
amendments of Directive 2004/37/EC – Interim report for cadmium and its inorganic compounds. 

101  See: http://oem.bmj.com/content/57/1/10;  
102  Kauppinen,  T.,  Toikkanen,  J.,  Pedersen,  D.,  Young,  R.,  Ahrens,  W.,  Boffetta,  P.,  Hansen,  J., 
Kromhout,  H.,  MaquedaBlasco,  J.,  Mirabelli,  D.,  de  la  Orden-Rivera,  V.,  Pannett,  B.,  Plato,  N., 
Savela,  A.,  Vincent,  R.  &Kogevinas,  M.  (2000):  Occupational  exposure  to  carcinogens  in  the 
European Union. Occ Environ Med 57, p. 10–18. 

107 

 
 
 
                                                            
report,  starting  with  scarcely  available  information  on  exposure  of  workers  as  such, 
outdated  information  sources,  different  methodologies  used  by  different  authors,  and 
concentration on one of few countries only. 

Table 47: Published data – workforce exposed to cadmium and cadmium compounds 

Study 
CAREX 

ICdA103 
INRS104 
INRS 
ICdA) 
SUMER 

(adjusted  by 

ASA107 

Regex108 
Note: *Cadmium only 
Source: RPA (2018) 

Country 
EU-14 
France 
Finland 
EU-5 
EU-28 
France 
France 

France 

Finland 

Czech Republic 

Year/period 
1990-1993 (mean) 
1990-1993 
1990-1993 
1997 
2017 
2005 
2017 

No. of exposed workers 
207,000 
22,034 
1,040 
86,000 
2,900 
2,250-6,600 
900-1,100 

2003105 
2010106 
2005 
2014 
2009-2016 

27,700 
39,700 
964 
1,550 
49* 

The consultant has carried out extrapolations of the data above to the EU-28, summarised 
below. 

103  ICdA (2017a):  Where and how many workers are occupationally exposed to Cd and Cd compounds in 

the EU? http://www.cadmium.org/ 

104  See http://www.inrs.fr/publications/bdd/cmr.html 
105  http://dares.travail-emploi.gouv.fr/dares-etudes-et-statistiques/enquetes-de-a-a-z/article/surveillance-

medicale-des-expositions-aux-risques-professionnels-sumer-edition-115982 

106  http://dares.travail-emploi.gouv.fr/dares-etudes-et-statistiques/enquetes-de-a-a-z/article/surveillance-

medicale-des-expositions-aux-risques-professionnels-sumer-edition 

107  Finnish Register of Workers Exposed to Carcinogens.  

See http://www.julkari.fi/bitstream/handle/10024/131073/ASA_2014.pdf?sequence=1 

108  Registry of Subjects Occupationally Exposed to Carcinogens (REGEX). 

108 

 
 
 
                                                            
Table 48: Population occupationally exposed to cadmium and cadmium compounds in the 

EU-28 

Source estimate 
SUMER 2010109 exposed workers in FR 
CAREX EU14+5 mid-1990s 
ASA 2014 exposed workers in FI 
ASA 2005 exposed workers in FI 
INRS 2005 FR exposed workers in FR 
INRS 2005 adjusted by ICdA for 2017, exposed workers in FR 
ICdA 2017 (EU-28 estimate, no extrapolation) 
Regex 2009-16, exposed workers in CZ 
Note:  All extrapolations have been carried out on the basis of population. 
Source: RPA (2018) 

EU-28 extrapolation 

300,000 

140,000 
90,000 
17,000-50,000 
6,800 – 8,400 
2,900 
2,400 

The  International  Cadmium  Association  (ICdA)  is  using  data  from  its  occupational 
exposure biomonitoring programme and estimates that approximately 2,900 workers are 
occupationally exposed to cadmium and cadmium compounds in the EU. 

Occupations in which the highest potential exposures occur include cadmium production 
and  refining,  nickel-cadmium  (Ni-Cd)  battery  manufacture,  cadmium  pigment 
manufacture  and  formulation,  cadmium  alloy  production,  mechanical  plating,  zinc 
smelting,  brazing  with  a  silver-cadmium-silver  alloy  solder,  and  polyvinylchloride 
compounding.110  Recycling  of  scrap  metal  and  Ni-Cd  batteries  may  also  involve  some 
exposure.111 

The  major  routes  of  occupational  exposure  are  inhalation  of  dust  and  fumes  and 
incidental ingestion of dust from contaminated hands, cigarettes or food.112. 

In industrial settings, airborne exposure levels typically have been reported to range from 
0.005 to 0.05 mg/m³; with extreme values up to 0.4 mg/m³113. 

109  http://dares.travail-emploi.gouv.fr/dares-etudes-et-statistiques/enquetes-de-a-a-z/article/surveillance-

medicale-des-expositions-aux-risques-professionnels-sumer-edition 

110  IARC 

(2016)  Monograph: 

Cadmium 

and 

Cadmium 

Compounds.Available 

at: 

https://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-8.pdf 

111  SCOEL (2017): Recommendation from the Scientific Committee on Occupational Exposure Limits for 
at: 
compounds. 

SCOEL/OPIN/336. 

Available 

Cadmium 
https://circabc.europa.eu/sd/a/13cad802-1f3c-40c0-bce4-6838cf5fc4ff/OPIN-
336%20Cadmium%20and%20its%20inorganic%20compounds.pdf 

inorganic 

and 

its 

112  SCOEL (2017): Recommendation from the Scientific Committee on Occupational Exposure Limits for 
at: 
compounds. 

SCOEL/OPIN/336. 

Available 

Cadmium 
https://circabc.europa.eu/sd/a/13cad802-1f3c-40c0-bce4-6838cf5fc4ff/OPIN-
336%20Cadmium%20and%20its%20inorganic%20compounds.pdf 

inorganic 

and 

its 

113  JRC  (2007)  European  Union  Risk  Assessment  Report  -  Volume  74  cadmium  metal,  Part  II:  Human 
Health (publication EUR 22767 EN). Available at: https://echa.europa.eu/documents/10162/4ea8883d-
bd43-45fb-86a3-14fa6fa9e6f3 

109 

 
 
 
 
 
 
                                                            
 
Beryllium and its inorganic compounds 

Relevant sectors, uses and activities 

The RPA (2018) study identified ten industrial sectors as using beryllium. The following 
sectors where occupational exposure is expected to take place are the following: 

Table 49: Sectors in the EU affected by beryllium and associated NACE codes 

Sector 
Foundries 
Metal fabrication (includes manufacture of injection moulds and 
stamping) 
Transportation 
Sector 
ICT 
Specialist manufacturers including defence, security, fire-fighting 
& rescue, oil gas and electricity, space and research 
Medical devices 
Glass 
Construction 
Laboratories 
Recycling 
Source: RPA (2018) 

Associated NACE codes 
C24 
C25 

C29 & C30 
Associated NACE codes 
C26 
C27, C28, C33 

C32.5 
C23.1 
F 
M72 
E37.1 

In these sectors, the uses presented in the next table were identified.  

The  list  was  provided  by  BeST  and  also  gives  an  indication  of  whether  or  not  they 
believe  the  process  would  be  technically  feasible  and  economically  viable  at  different 
OELs (see explanation of the abbreviations used at the end of this table).  

110 

 
 
 
 
Table 50: Processes using beryllium, their technical feasibility and economic viability at different exposure levels, and their process group 

Process 

Detail 

Abrasive Blasting  A process for cleaning the surface of metals or ceramics which involves using compressed 

air to blow an abrasive material (i.e., sand) with considerable force through a hose 
against a surface. 

2 μg 
/m3 
C 

0.6 μg 
/m3 

C+ 

0.2 μg 

/m3 

NF 

0.1μg 
/m3 

NF 

0.02μg 
/m3 

NF 

Process group 

Abrasive 

Processes that involve cleaning or altering the surface of metals or ceramics by abrasive 

Processing 

action, utilizing natural or manufactured abrasive materials. 

Abrasive Sawing 

The process of sawing metals or ceramics by abrasive action. 

C 

C 

C+ 

C+ 

NF 

NF 

NF 

NF 

NF 

NF 

Adhesive 

Bonding 
Age Hardening 
(<950ºF) 
Annealing 

Assembly 

Bending 

Blanking 

Bonding 

Boring 

The process of joining two similar or non-similar materials (metals, plastics, composites, 

NA 

NA 

NA 

NA 

NA 

etc.) using an adhesive. 

The process of increasing the strength and hardness of a metallic material using a 

NA 

NA 

relatively low-temperature heat treatment. 

The controlled heating and cooling of a metal to remove stresses and to make the material 

NA 

NA 

softer and easier to work with during subsequent operations such as rolling. 

The fitting together of manufactured parts into a complete machine, structure or unit of a 

NA 

NA 

machine. 

The process in which metal is deformed by plastically deforming the material and 

NA 

NA 

C 

C 

NA 

NA 

C 

C 

NA 

NA 

C 

C 

NA 

NA 

changing its shape.  The material is stressed beyond the yield strength, but below the 
ultimate tensile strength.  The surface area of the material does not change much.  
Bending usually refers to deformation about one axis. 

The process of cutting up a large sheet of stock into smaller pieces suitable for the next 
operation in stamping.  Blanking can be as simple as a cookie cutter-type die to 
produce prototype parts, or high speed dies that run at 1000+ strokes per minute, 
running coil stock. 

NA 

NA 

C 

C 

C 

The process of joining two materials together by passing the metal between rolls which 

NA 

NA 

NA 

NA 

NA 

compress and bond the metals together. 

The formation of a cylindrical hole in a solid material cutting tool. 

NA 

NA 

C 

C 

C 

111 

Mechanical - 
machining 
Mechanical - 
machining 
Mechanical - 
machining 

Handling 

Thermal 

Thermal 

Handling 

Mechanical - shaping 

Mechanical - 
machining 

Handling 

Mechanical - 

 
 
 
Process 

Brazing 

Detail 

Joining metals by the fusion of alloys having a melting temperature above 800 degrees 
Fahrenheit, but below the melting temperature of the metals being joined.  In 
ceramics, refers to the joining of a plated surface to another metal component at 
temperatures typically less than 1100 degrees Celsius. 

2 μg 
/m3 

0.6 μg 
/m3 

0.2 μg 

/m3 

0.1μg 
/m3 

0.02μg 
/m3 

NA 

NA 

C 

C 

C 

Process group 

machining 

Bright Cleaning 

A process in which metallic pieces are dipped into an acid solution in order to achieve a 

C 

C 

C+ 

C+ 

NF 

Broaching 

Brushing 

Buffing 

clean, bright surface. 

Multiple milling, accomplished by pushing a tool with stepped cutting edges along the 

NA 

NA 

part, usually through holes. 

The process of cleaning the surface of metal using a brush.  The bristles of the brush can 

be soft or hard; natural, synthetic or metallic. 

The smoothing of a metal surface by means of flexible wheels. 

Burnishing 

The process in which a smooth hard tool (using sufficient pressure) is rubbed on the metal 

surface to flatten the high spots by causing plastic flow of the metal. 

Casting 

The process of pouring a heated liquid metal into a mould.  Once the metal solidifies, 

taking the shape inside the mould, it is removed, resulting in a cast shape. 

A grinding process that differs from other cylindrical processes in that the work piece is 

not mechanically held in place at the centre. 

Centreless 
Grinding 
Chemical 
Cleaning 
Chemical Etching 
Chemical Milling  The process of controlled removal of metal using corrosive chemicals. 
CNC Machining 

Involves removing the surface of a metal chemically or electrochemically. 

chemicals. 

The process of removing oil, dirt and scale from the surface of metals using caustic 

Computerized Numerically Controlled (CNC) machining refers to the computer control of 
machine tools for the purpose of repeatedly manufacturing complex parts in metal. 
Involves the working of metal at normal atmospheric temperatures, to a predetermined 

Cold Forging 

shape by the process of hammering, upsetting, pressing or rolling. 

Cold Heading 

A cold forming process that involves applying force with a punch to the end of a metal 

NA 

NA 

blank contained in a die to redistribute metal to a particular area. 

112 

C 

C 

C 

C 

C 

C 

C 
C 
NA 

NA 

C 

C 

C 

C 

C+ 

C 

C 
C 
NA 

C 

C 

C+ 

C+ 

C+ 

NF 

NF 

C+ 

C+ 
C+ 
C 

C+ 

C 

C 

C+ 

C+ 

C+ 

NF 

NF 

C+ 

C+ 
C+ 
C 

C+ 

C 

C 

NF 

NF 

NF 

NF 

NF 

NF 

NF 
NF 
C+ 

NF 

C+ 

Thermal 

Chemical 
Mechanical - 
machining 
Mechanical - 
machining 
Mechanical - 
machining 
Mechanical - 
machining 

Melting 
Mechanical - 
machining 

Chemical 
Chemical 
Chemical 
Mechanical - 
machining 

Mechanical - shaping 

Mechanical - shaping 

 
 
A finishing step involving the removal of burrs or surface imperfections from materials 

C 

C 

C+ 

C+ 

using abrasive activities such as sanding. 

Process 

Cold Pilger 
Cold Rolling 

Coolant 
Management 

Detail 

The drawing technique employed to produce seamless tubing using a die and mandrel. 
The process of shaping and reducing metal in thickness by passing it between rolls which 
compress, shape and lengthen the metal, at a temperature below the softening point of 
the metal to create strain hardening. 

2 μg 
/m3 

NA 
NA 

0.6 μg 
/m3 

NA 
NA 

Involves the handling and management of the liquids used to quench metals in heat 

NA 

C 

treating, to cool and lubricate cutting tools and workpieces in machining, or those 
applied to forming tools and workpieces to assist in forming operations. 

Cutting 

The process of mechanically shearing metal. 

NA 

NA 

Deburring 
(grinding) 
Deburring (non-
grinding) 
Deep Hole 
Drilling 
Destructive 
Testing 
Drawing 

The removal of burrs, sharp edges or fins from metal parts by processes other than 

NA 

NA 

grinding, such as filing, machining or tumbling. 
To form deeply drilled holes with a rotary end cutting tool. 

NA 

NA 

Refers to testing a workpiece for comparison to standards, where the testing results in the 

C 

C 

destruction of the work piece. 

A manufacturing process for producing a wire, bar or tube by pulling the material through 

NA 

NA 

a die to reduce the diameter and increase its length. 

Drilling 

The process of using a drill bit in a drill to produce holes in a solid material. 

NA 

NA 

Dross Handling 

The process of physically handling dross produced by the melting of metals and alloys 

C 

throughout manufacturing, packaging and shipping. 

Dry Tumbling 

A process used to remove burrs, sharp edges or fins from metal parts by rolling the work 

NA 

in a barrel with other materials. 

The process of removing material using electrical energy created in an electrolyte solution 

C 

to erode metal from the workpiece. 

Electrical 
Chemical 
Machining 
(ECM) 

C 

C 

C 

113 

0.2 μg 

/m3 

0.1μg 
/m3 

0.02μg 
/m3 

C 
C 

C 

C 

C 
C 

C 

C 

C 

C 

C 

C 

C 

NF 

C+ 

C+ 

C 

C 

C 

C 

C 

NF 

C+ 

C+ 

C+ 
C 

C+ 

C+ 

C+ 

C+ 

C+ 

C+ 

C+ 

C+ 

NF 

NF 

NF 

Process group 

Mechanical - shaping 

Mechanical - shaping 

Handling 
Mechanical - 
machining 
Mechanical - 
machining 
Mechanical - 
machining 
Mechanical - 
machining 
Mechanical - 
machining 

Mechanical - shaping 
Mechanical - 
machining 

Melting 
Mechanical - 
machining 

Chemical 

 
 
Process 

Electrical 
Discharge 
Machining 
(EDM) 
Electroless 
Plating 
Electron Beam 
Welding (EBW) 
Electroplating 

Etching 
(chemical) 
Extrusion 

Detail 

The process of removing material by a series of rapidly recurring electric arcing 

discharges between an electrode (the cutting tool) and the work piece, in the presence 
of an energetic electric field.  This is sometimes referred to as spark machining or 
spark eroding. 

2 μg 
/m3 
C 

0.6 μg 
/m3 

C 

0.2 μg 

/m3 

C+ 

0.1μg 
/m3 

C+ 

0.02μg 
/m3 

NF 

Process group 

A process in which a layer of metal contained in an aqueous solution is deposited (coated) 

NA 

NA 

C 

C 

onto a surface without the use of external electrical power. 

A fusion joining process that produces a weld by impinging a beam of high energy 

C 

C 

C+ 

C+ 

electrons to heat the weld joint. 

A process in which a layer of metal contained in an aqueous solution is deposited (coated) 

NA 

NA 

onto an electrically conductive surface using an electrical current. 

A process which involves chemically or electrochemically removing the surface of a 

C 

C 

metal. 

The process of shaping metal into a chosen continuous form by forcing it through a die of 

NA 

NA 

a desired shape. 

Filing by Hand 

The non-mechanized process of using a metalworking hand tool (a file) to shape material. 

NA 

NA 

Forging 

Grinding 

The process of working a heated metal to a predetermined shape by hammering, upsetting, 

NA 

C 

pressing or rolling. 

A process that uses friction with a rough surface, such as an abrasive wheel, on the 

C 

C+ 

workpiece to make very fine finishes or very light cuts. 

Gun Drilling 

A process where a drill, usually with one or more flutes and with coolant passages through 

NA 

NA 

the drill body, is used to produce a deep-drilled hole. 

Hand Solvent 
Cleaning 
Handling 

Heading 

The non-mechanized process of cleaning the surface of a part using a solvent. 

NA 

NA 

The process of physically handling materials or products throughout manufacturing, 

NA 

NA 

packaging, distribution and shipping. 

A cold forming process that essentially involves applying force with a punch to the end of 
a metal blank contained in a die.  Heading, which includes upsetting and extruding, is 
often performed in conjunction with other cold forming operations such as sizing, 

NA 

NA 

C 

114 

C+ 

C+ 

C+ 

NF 

C+ 

C 

NF 

NF 

C+ 

NA 

NA 

C+ 

Melting 

Chemical 

Melting 

Chemical 

Chemical 

Mechanical - shaping 
Mechanical - 
machining 

Mechanical - shaping 
Mechanical - 
machining 
Mechanical - 
machining 

Handling 

Handling 

Mechanical - shaping 

C 

C+ 

C+ 

C 

C+ 

NF 

C 

NA 

NA 

C 

C+ 

C+ 

C 

C+ 

NF 

C 

NA 

NA 

C 

 
 
piercing, trimming, thread rolling, blank rolling and pointing. 

The process of heating and cooling solid metals, alloys or ceramics in an inert atmosphere, 

NA 

NA 

C 

C 

C 

Detail 

2 μg 
/m3 

0.6 μg 
/m3 

0.2 μg 

/m3 

0.1μg 
/m3 

0.02μg 
/m3 

Process group 

Process 

Heat Treating 
(inert atmosphere) 

Heat Treating (in 
air) 
High Speed 
Machining 
(>10,000 rpm) 
Honing 

such as nitrogen gas, to obtain certain desired properties or characteristics.  The inert 
atmosphere excludes oxygen and reduces the generation of oxides on the surface of 
the metal or alloy. 

The process of heating and cooling solid metals, alloys or ceramics in normal atmosphere 

to obtain certain desired properties or characteristics. 

Material-working processes that involve using a power-driven machine tool, such as a 

router or drill, at speeds in excess of 10,000 rpm to shape metal. 

C 

C 

The process of finishing ground surfaces to a high degree of accuracy and smoothness 

NA 

with abrasive blocks applied to the surface under a light controlled pressure, with a 
combination of rotary and reciprocating motions. 

Hot Forging 

The process of working a heated metal to a predetermined shape by hammering, upsetting, 

NA 

pressing or rolling. 

Hot Rolling 

A metallurgical process in which the metal is passed through a pair of rolls while the 

NA 

metal is above its recrystallization temperature. 

Inspection 

Investment 
Casting 
Lapping 

specifications. 

The process of producing castings of a part using ceramic moulds produced by injection 

moulding. 

An abrasive machining operation that scours the surface of the work piece with an 

abrasive in fluid. 

Laser Cutting 

A process which uses a laser to cut materials.  The material to be cut either melts, burns or 

vaporizes away. 

Laser Machining  A process which uses a laser to machine materials.  The material either melts, burns or 

vaporizes away. 

Laser Scribing 

A process that uses a laser to cut grooves into the surface of thin material to facilitate 

mechanical breaking. 

115 

C 

C 

C 

C 

C 

C 

C 

C+ 

C+ 

C+ 

NF 

C+ 

C+ 

NF 

C+ 

C+ 

C+ 

C+ 

NF 

NF 

C 

C 

C 

C 

C 

C 

C 

C 

C 

C 

NF 

C+ 

C+ 

C+ 

C+ 

NF 

C+ 

C+ 

C+ 

C+ 

NF 

NF 

NF 

NF 

NF 

Thermal 

Thermal 

Mechanical - 
machining 

Mechanical - 
machining 

Mechanical - shaping 

Mechanical - shaping 

Handling 

Melting 
Mechanical - 
machining 

Melting 

Melting 

Melting 

The evaluation of a part for defects, imperfections and preferred characteristics and 

NA 

NA 

NA 

NA 

NA 

 
 
Process 

Laser Marking 
Laser Welding 
Laundering 
Machining 

Melting 
Metallography 

Milling 

Packaging 

Painting 
Physical Testing 

Photo-Etching 

Pickling 

Piercing 
Pilger 
Plating 
Point and 
Chamfer 
Polishing 

Pressing 

Detail 

A process that uses a laser to mark the surface of a material for identification purposes. 
A process that uses a laser to weld metals. 
The washing and drying of work clothing, rags, etc. 
Material-working processes that involve using a power-driven machine tool such as a 

lathe, milling machine or drill to shape metal. 

The processes of heating a solid substance to a point where it turns liquid. 
The process of preparing a metal surface for analysis by grinding, polishing, and etching 

to reveal micro structural constituents. 

2 μg 
/m3 
C 
C 
C 
NA 

C 
NA 

C 
C 
C 
NA 

C 
NA 

The machining or cutting of metal products with revolving cutters. 

NA 

NA 

The process of placing finished and/or semi-finished products into a container for 

NA 

NA 

shipping. 

The process of applying paint to the surface of a finished or semi-finished part. 
An examination or formal evaluation process whereby a material, semi-finished or 
finished product, is tested and the results typically compared to specified 
requirements and standards.  Can be destructive or non-destructive in nature. 

A chemical etching process that dissolves material from unmasked areas of metallic parts.  
The design is photographically exposed on the workpiece using ultraviolet light. 
The process of chemically removing oxides and scale from the surface of metal using 

inorganic acids. 

The process of cutting internal features (holes or slots) in stock. 
The process employed to produce seamless tubing using a die and mandrel. 
The process of applying a thin coating of metal onto another metal. 
A process used to grind or machine a point or bevel on the end of a rod or wire which 

facilitates insertion into a drawing machine. 

NA 
NA 

C 

C 

NA 
NA 
NA 
C 

NA 
NA 

C 

C 

NA 
NA 
NA 
C 

The process of creating a smooth and shiny surface by rubbing the surface with a fine 

C 

C 

abrasive material. 

The process in which metal is deformed by plastically deforming the material and 

NA 

NA 

116 

0.6 μg 
/m3 

0.2 μg 

/m3 

0.1μg 
/m3 

0.02μg 
/m3 

Process group 

C+ 
C+ 
C+ 
C 

NF 
C 

C 

NA 

NA 
C 

C+ 

C+ 

C 
C 
C 
C+ 

C+ 

C 

C+ 
C+ 
C+ 
C 

NF 
C 

C 

NA 

NA 
C 

C+ 

C+ 

C 
C 
C 
C+ 

C+ 

C 

NF 
NF 
NF 
C+ 

NF 
C 

C+ 

NA 

NA 
C+ 

NF 

NF 

C+ 
C 
C+ 
NF 

NF 

Melting 
Melting 
Handling 
Mechanical - 
machining 
Melting 
Mechanical - 
machining 
Mechanical - 
machining 

Handling 
Handling 

Mechanical - 
machining 

Chemical 

Chemical 
Mechanical - shaping 
Mechanical - shaping 
Chemical 
Mechanical - 
machining 
Mechanical - 
machining 

C 

Mechanical - shaping 

 
 
Process 

Detail 

2 μg 
/m3 

0.6 μg 
/m3 

0.2 μg 

/m3 

0.1μg 
/m3 

0.02μg 
/m3 

Process group 

Process 
Ventilation 
Maintenance 
Radiography/X-
ray 

changing its shape.  The material is stressed beyond the yield strength, but below the 
ultimate tensile strength.  The surface area of the material does not change much. 
The preventive or reactive repair, maintenance or restoration of general or local exhaust 
ventilation systems.  Process ventilation refers to ventilation systems designed to 
reduce exposure to contaminants. 

C 

C+ 

NF 

NF 

NF 

A method of non-destructive testing.  Internal examination of a metallic structure or 

NA 

NA 

NA 

NA 

NA 

component with X-ray or gamma radiation.  Internal defects can be seen on a screen 
or recorded on film. 

Reaming 

To enlarge or dress out a hole in metal with a reamer. 

NA 

NA 

Resistance 
Welding 
Ring Forging 

Ring Rolling 

A process where heat to form the weld is generated by the electrical resistance of current 

C 

through the workpieces. 

The process performed by punching a hole in a thick, round piece of metal, and then 

rolling and squeezing (or in some cases, pounding) the seamless shape to a thin ring. 

The process of forming seamless rings from pierced discs or thick-walled, ring-shaped 
blanks between rolls that control wall thickness, ring diameter, height and contour. 

NA 

NA 

C 

C 

C 

Roll Bonding 

The process of bonding two metals together by passing the metal between rolls which 

NA 

NA 

compress and bond the metals together. 

C 

C+ 

C+ 

C+ 

C 

C 

C+ 

C+ 

C+ 

C 

C+ 

NF 

NF 

NF 

C 

Roller Burnishing  The process in which a smooth hard roller tool (using sufficient pressure) is rubbed on the 

C 

C 

C+ 

C+ 

NF 

metal surface to flatten the high spots by causing plastic flow of the metal. 

Rolling 

A term applied to the operation of shaping and reducing metal in thickness by passing the 

NA 

NA 

metal between rolls which compress, shape and lengthen the metal. 

Rotary forging 

A process designed to efficiently forge round (cylindrical) shapes by hammering, 

NA 

C 

upsetting, pressing or rolling. 

Sand Blasting 

A process for cleaning the surface of metals or ceramics which involves using compressed 

C 

C+ 

air to blow sand with considerable force through a hose against a surface.  In 
ceramics, commonly used to remove metallization as a rework operation. 

Sand Casting 
Sanding 

The production of a metal casting made in a sand mould 
A process used to smooth or dress the surface of a workpiece using an abrasive surface. 

C 
C 

C+ 
C+ 

C 

C+ 

NF 

NF 
NF 

C 

C+ 

NF 

NF 
NF 

C 

NF 

NF 

NF 
NF 

Handling & 

Machining 

Handling 
Mechanical - 
machining 

Melting 

Mechanical - shaping 

Mechanical - shaping 

Mechanical - shaping 

Mechanical - shaping 

Mechanical - shaping 

Mechanical - shaping 

Mechanical - 
machining 
Melting 

Mechanical - 

117 

 
 
Process 

Sawing (tooth 
blade) 
Scrap 
Management 
(Clean) 
Sectioning 

Shearing 

Shipping 

Sizing 

Skiving 

Detail 

2 μg 
/m3 

0.6 μg 
/m3 

0.2 μg 

/m3 

0.1μg 
/m3 

0.02μg 
/m3 

A manufacturing process that involves cutting or severing of metal or other materials with 

NA 

NA 

C 

C 

a serrated blade. 

Refers to the routine handling, transfer, segregating or transport of scrap materials. 

C 

C 

C+ 

C+ 

The process of obtaining a smaller piece of material from a larger sample of the material.  

NA 

NA 

The process can involve fracturing, sawing and/or abrasive cutting. 

The process of severing of metal, usually cold, between sharpened blades, as in a shear; to 
severe or rupture a part as a result of forces in parallel planes that slide across each 
other at right angles to a major axis of the part. 

NA 

NA 

C 

C 

C 

C 

C+ 

NF 

C+ 

C+ 

The process of transporting a finished and/or semi-finished product to a destination using 

NA 

NA 

NA 

NA 

NA 

various modes of transportation. 

Refers to the various mechanical processes to bring a work piece to the proper shape and 

NA 

NA 

dimensions. 

A continuous shaving process which results in a smoother surface finish than is possible 

NA 

NA 

with milling. 

Slab Milling 

The milling process used to remove large amounts of material, leaving a flat finished 

NA 

NA 

surface. 

Slitting 

The operation of cutting wide sheets of metal into narrower strips by passing them through 

NA 

NA 

rotary shears that cut it to finished width. 

Soldering 
Solution 
Management 

Joining metals by fusion of alloys that have relatively low melting points. 
Refers to routine handling, transfer, transport or processing of beryllium-containing 

NA 
NA 

NA 
NA 

NA 
C 

NA 
C 

solutions, such as coolants, oils and other liquids containing beryllium, beryllium 
oxide or alloys of beryllium. 

Spot Welding 

The process of welding two or more thin pieces of metal together using electrical 

C 

C 

C+ 

C+ 

resistance to heat the metal at the spot of the weld. 

Sputtering 

The physical process where atoms of a solid target material are ejected into the gas phase 

NA 

NA 

C 

C 

due to bombardment of the material by energetic ions and deposited on a substrate. 

118 

C 

C 

C 

C 

C 

C 

C 

C 

C 

C+ 

NF 

C+ 

NA 
C+ 

NF 

c+ 

Process group 

machining 
Mechanical - 
machining 

Handling 
Mechanical - 
machining 

Mechanical - shaping 
Handling & 

Machining 

Mechanical - shaping 

Mechanical - shaping 
Mechanical - 
machining 

Mechanical - shaping 
Thermal 

Handling 

Melting 

Melting 

 
 
Process 

Stamping 

Straightening 
Stretch Bend 
Levelling 
Stretcher 
Levelling 
Swaging 

Detail 

The formation of light metal parts from metal sheet, strip or thin plate, using dies. 

Metal forming in which a bend is removed from a piece of metal by applying a force. 
The process of making metal sheet or strip flat by stretching. 

The process of making metal sheet or strip flat by stretching. 

2 μg 
/m3 

NA 

NA 
NA 

0.6 μg 
/m3 

NA 

NA 
NA 

NA 

NA 

0.2 μg 

/m3 

0.1μg 
/m3 

C 

C 
C 

C 

C 

C 
C 

C 

0.02μg 
/m3 

c+ 

c 
c 

c 

The process of using a die and mandrel along with hammering to change the size and 

NA 

NA 

C+ 

C+ 

NF 

shape of the outer and inter diameters of tubes and/or rods. 

Tapping 

The process of cutting screw threads in a round hole with a tap (an internal thread cutting 

NA 

NA 

tool). 

Tensile Testing 

A standard test piece is gripped at either end in a testing machine, which slowly exerts an 

NA 

NA 

axial pull so that the metal is stretched until it breaks. 

Thread Rolling 

The process used for making external threads in round stock by pressing the rotating 

NA 

NA 

workpiece against a die containing the thread profile. 

C 

C 

C 

C 

C 

C 

C 

C 

C 

Torch cutting 
(i.e., oxy-
acetylene) 
Trepanning 

Tumbling 

Turning 

Ultrasonic 
Cleaning 
Ultrasonic 
Testing 

The process of cutting metals by using an oxygen/fuel mixture to heat the metal above the 

C 

C+ 

C+ 

C+ 

NF 

melting point. 

A type of boring where an annular cut is made into a solid material with the coincidental 

NA 

NA 

C 

C 

formation of a plug or solid cylinder. 

A deburring operation that involves rolling the work in a barrel containing abrasives 

NA 

C 

C+ 

C+ 

suspended in a liquid medium. 

The process used to produce cylindrical components in a lathe.  A cylindrical piece of 

NA 

NA 

C 

C 

stock is rotated and a cutting tool is traversed along 2 axes of motion to produce 
precise diameters and depths. 

The process of cleaning the surface of materials using ultrasound (usually from 15-400 

NA 

NA 

kHz) in an aqueous solution. 

The process of using ultrasound to detect flaws or characterize materials. 

NA 

NA 

NA 

NA 

NA 

NA 

c+ 

NF 

c+ 

NA 

NA 

Process group 

Mechanical - 
machining 

Mechanical - shaping 

Mechanical - shaping 

Mechanical - shaping 

Mechanical - shaping 
Mechanical - 
machining 
Mechanical - 
machining 

Mechanical - shaping 

Melting 
Mechanical - 
machining 
Mechanical - 
machining 

Mechanical - 
machining 

Handling 

Handling 

119 

 
 
Process 

Upsetting 

Detail 

A cold forming process that involves applying force with a punch to the end of a metal 

blank contained in a die. 

Water-jet Cutting  A process to cut metal parts using a very high-pressure stream of water. 

A process used to join metals by the application of heat. 

The process of removing material by a series of rapidly recurring electric arcing 
discharges from a thin single-strand metal wire fed through the workpiece. 

Welding (ARC, 
TIG, MIG, etc.) 
Wire Electrical 
Discharge 
Machining 
Source: RPA and BeST 
NA = No additional controls required beyond normal operating controls 
C = Controls required including engineering work and best practice 
C+ = Additional advanced controls are necessary but not likely to be economically feasible 
NF = Not technically feasible 

2 μg 
/m3 

NA 

C 

C 

C 

0.6 μg 
/m3 

0.2 μg 

/m3 

0.1μg 
/m3 

0.02μg 
/m3 

Process group 

C 

C 

C 

C 

C+ 

C+ 

C+ 

C+ 

C+ 

C+ 

C+ 

C+ 

NF 

NF 

NF 

NF 

Mechanical - shaping 
Mechanical - 
machining 

Melting 

Melting 

120 

 
 
 
 
The processes are grouped into a smaller set of higher level processes to make analysis 
easier.  The process groups are: 

  Mechanical – shaping 
  Mechanical – machining 
  Melting 
  Thermal 
  Chemical 
  Handling 

The sectors were then linked to the appropriate process groups and these are described in 
the table below.  Mechanical - machining and mechanical - shaping were found to always 
appear together: they are amalgamated in mechanical.  Handling is found in every sector 
and  has  little  bearing  on  costs,  so  it  is  omitted.  This  information  helped  in  the 
development of risk management measures (RMMs) for the cost model. 

Table 51: Sectors, and the group processes predominantly used 

Sector 
Foundries 
Metal fabrication  
Transportation 

ICT 

Specialist manufacturers  

Medical devices 

Glass 
Construction 
Laboratories 
Recycling 
Source: RPA and BeST 

Chemical 
N 
N 
Y 

Y 

Y 

Y 

Y 
N 
Y 
N 

Thermal  Mechanical 

N 
N 
Y 

Y 

Y 

Y 

Y 
N 
N 
N 

N 
Y 
Y 

Y 

Y 

Y 

Y 
Y 
N 
Y 

Melt 
Y 
N 
Y 

N 

Y 

N 

Y 
N 
N 
Y 

Alloys 

Cu-Be alloys 
BeO 
Al-Be alloys 
Cu-Be alloys 
(typically 
0.2-2% Be 
metal) 
Cu-Be alloys 
Ni-Be alloys 
BeO 
Be 
Al-Be 
Be metal 
Cu-Be alloys 
Be foil 
BeO 
? 
? 
? 
ALL 

Estimated EU workers exposed 

According to the consultant, ten industrial sectors were identified in which beryllium and 
its compounds are used, and in which workers are at risk of exposure to beryllium:  

121 

 
 
 
 
 
 
 
Table 52: Sectors in the EU affected by beryllium and associated NACE codes 

Sector 
Foundries 
Metal fabrication (includes manufacture of injection moulds and 

stamping) 
Transportation 
ICT 
Specialist manufacturers including defence, security, fire-fighting & 
rescue, oil gas and electricity, space and research 
Medical devices 
Glass 
Construction 
Laboratories 
Recycling 
Source: RPA (2018) 

Associated NACE codes 
C24 
C25 

C29 & C30 
C26 
C27, C28, C33 

C32.5 
C23.1 
F 
M72 
E37.1 

The following average exposure concentrations were calculated based on the information 
sources provided at the end of the following table: 

Table 53:Sectors in the EU affected by beryllium and any available average exposure 

concentrations in µg/m3 

Sector 

Foundries 
Metal fabrication  
Transportation 
ICT 
Specialist manufacturers  
Medical devices 
Glass 
Construction 
Laboratories 
Recycling 
Source: RPA, MEGA, France 2004-2006 - Vincent et al. 
Note: * The value has been taken from the category 'other sectors' in the database  

MEGA 114 
95th percentile115 
1.05 (n=101) 
0.228 (n=79) 
0.554 (n=14) 
0.512 (n=33) * 
0.512 (n=33) * 
0.512 (n=33) * 
2.78 (n=16) 
2.52 (n=10) 
0.512 (n=33) * 
0.19 (n=116) 

France116 
90th percentile117 
16.06 (n=159) 
0.6 (n=76) 
0.015 (n=14) 
10.44 (n=29) 
- 
0.5 (n=74) 
- 
- 
- 
0.1 (n=30) 

Three different methods were  used  to  arrive at  estimates  of the number of EU  workers 
exposed to beryllium.  All three methods use US-OSHA Table IX-2118  – “Characteristics 
of  industries  affected  by  US-OSHA’s  proposed standard  for  beryllium”.    This  provides 

114  BAuA.Substance  Evaluation  Report-  Beryllium.  http://echa.europa.eu/documents/10162/a99d2dc4-
c217-4024-b6ed-9c7262e2ba56  IFA  (2013):  MEGA-Auswertungen  zur  Erstellung  von  REACH- 
Expositionsszenarien für Beryllium und seine Verbindungen. 2014. 

115  A  percentile  is  a  measure  used  in  statistics  indicating  the  valuebelow  which  a  given  percentage  of 
observations fall. For example, the 95th percentile is the value below which 95% of the observations 
may be found. 
et 

116  Vincent 

enterprises 

beryllium 

French 

2009 

in 

to 

al.Occupational 
https://www.ncbi.nlm.nih.gov/pubmed/19372137 

exposure 

117  A  percentile  is  a  measure  used  in  statistics  indicating  the  value  below  which  a  given  percentage  of 
observations fall. For example, the 90th percentile is the value below which 90% of the observations 
may be found. 

118  US-OSHA, Occupational Safety and Health Administration.Occupational Exposure to Beryllium and 

Beryllium Compounds 2015. Available at: 
www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGISTER&p_id=25346 

122 

 
 
 
 
                                                            
the number of USA workers exposed to beryllium for each relevant NAIC code, which is 
mapped  to  the  relevant  NACE  code(s).    This  data  is  available  for  seven  of  the  sectors 
identified  by  the  study,  all  except  construction,  laboratories  and  recycling.    The  three 
methods are referred to throughout the remainder of this report as Beryllium Science and 
Technology Association (BeST), EU/USA and US-OSHA.  They are: 

  BeST  -  BeST  say  that  the  total  number  of  workers  exposed  to  beryllium  in  the 
EU is 12,000 to 13,000.  The higher number, 13,000, was split across the seven 
sectors according to the proportions of exposed workers.  The higher number was 
taken  as  this  number  is  more  likely  to  be  an  understatement  rather  than  an 
overstatement  

  EU/USA  -  The  number  of  exposed  workers  in  each  of  the  seven  sectors  is 
multiplied by 1.5, which is the proportion of EU population (510 million) to USA  
population (326 million) 

  US-OSHA  -  The  number  of  exposed  workers  in  each  of  the  seven  sectors  is 
divided by the total number of USA workers corresponding to the NACE119 code, 
which gives the percentage of exposed workers in this industry. This is multiplied 
by the total number of EU workers for this NACE code 

The key information for exposed workers in each sector is given in following table.  

Table 54: USA and EU data on workers by sector 

% USA workers 
affected by 
beryllium 

Total workers in 
EU (Eurostat**) 

Sector 

USA workers in 
associated NAIC 
sectors (US-
OSHA) 
297,333 
1,530,220 
1,557,729 
778,433 

USA workers in 
associated NAIC 
sectors affected 
by beryllium 
3,262 
12,469 
2,048 
1,042 

2,052,363 

1.10% 
0.81% 
0.13% 
0.13% 

Foundries 
Metal fabrication  
Transportation 
ICT 
Specialist 
manufacturers  
Medical devices 
Glass 
Construction 
Laboratories 
Recycling 
Source: RPA Note: *Based on estimated percentages of workers affected by beryllium 
** Eurostat (2015): Structural Business Statistics. Available at: 
http://ec.europa.eu/eurostat/web/structural-business-statistics/data/database. 

297,762 
652,489 
9,784,621 
710,059 
22,685 

2.74% 
0.07% 
0.42% * 
0.42% * 
0.42% * 

8,148 
453 
- 
- 
- 

0.28% 

5,808 

930,187 
3,341,115 
3,155,749 
1,035,484 

5,368,786 

413,783 
287,788 
9,789,969 
606,352 
180,164 

The predicted workers affected by beryllium using each of the three methods are given in 
the next table. The relevant figures from the CAREX EU data are also displayed in that 
table. 

119  Eurostat.NACE Rev. 2 - US NAICS 2007 correspondence table 

http://ec.europa.eu/eurostat/ramon/documents/nace_2_us_naics_2007/NACE_Rev_2-
US_NAICS_2007-as_per_October_1st_2010.zip. 2007. 

123 

 
 
                                                            
Table 55: Predicted workers affected by beryllium by sector 

Sector 

CAREX estimate 
of EU workers 
affected by Be 

Predicted number 
of EU workers 
affected by Be 
(BeST) 
1,276 
4,878 
801 
408 

Predicted number 
of EU workers 
affected by Be 
(EU/USA) 
5,099 
19,491 
3,202 
1,628 

Predicted number 
of EU workers 
affected by Be 
(US-OSHA) 
10,205 
27,225 
4,149 
1,386 

2,272 

Foundries 
Metal fabrication  
Transportation 
ICT 
Specialist 
manufacturers  
Medical devices 
Glass 
Laboratories 
Recycling 
Total excluding 
construction 
Construction 
Total 
Source: RPA (2018)  Note: *Based on estimated percentages of workers affected by beryllium 

11,323 
783 
2,556* 
760* 

12,737 
709 
1,639* 
487* 

3,188 
177 
410* 
122* 

26,469* 
80,540 

41,276* 
114,856 

6,624* 
20,156 

73,580 

15,193 

54,071 

13,532 

9,079 

2,620 
5,743 
4,394 

3,798 

46,265 

1,040 

2,129 
N/A 
N/A 

65,989 

490 

66,479 

Examining the figures produced by the three methods, those using the BeST data appear 
to be too low: it seems likely that BeST has included the companies that it supplies and 
their  workers,  but  has  not  allowed  for  the  companies  that  are  further  down  the  supply 
chain. 
CAREX  EU120,121  and  the  IOM  report122  predicted  approximately  65,000  workers 
exposed in the EU. The estimate using the EU/USA method arrives at a figure of 54,071 
excluding construction, higher than the 13,000 of BeST and lower than the CAREX/IOM 
figure. Examining the data from the USA, and the number of workers in the EU in each 
of the sectors, the EU/USA figures are the most plausible. Throughout the remainder of 
the analysis, the EU/USA figures will be used, and sensitivity analysis is made using the 
BeST and US-OSHA data. 

The  estimated  numbers  of  workers  exposed  to  different  concentrations  of  beryllium  in 
each  sector  are  shown  in  the  tables  below.  These  are  based  upon  the  EU/USA  data  set 
described before. 

The first table shows the estimates using the BeST survey data; the percentage split of the 
exposure concentration range is the same for every sector, while the second table shows 
the estimates using US-OSHA data for the seven sectors covered by its worker data. The 
percentage  split  of  the  exposure  concentration  range  is  different  for  each  of  the  seven 
sectors. The first table also shows the each sector’s 95% exposure concentration (MEGA) 

120  See: http://oem.bmj.com/content/57/1/10;  
121  Kauppinen,  T.,  Toikkanen,  J.,  Pedersen,  D.,  Young,  R.,  Ahrens,  W.,  Boffetta,  P.,  Hansen,  J., 
Kromhout,  H.,  MaquedaBlasco,  J.,  Mirabelli,  D.,  de  la  Orden-Rivera,  V.,  Pannett,  B.,  Plato,  N., 
Savela,  A.,  Vincent,  R.  &Kogevinas,  M.  (2000):  Occupational  exposure  to  carcinogens  in  the 
European Union. Occ Environ Med 57, p. 10–18. 

122IOM, Institute of Occupational Medicine (2011): Health, socio-economic and environmental aspects of 
possible  amendments  to  the  EU  Directive  on  the  protection  of  workers  from  the  risks  related  to 
exposure  to  carcinogens  and  mutagens  at  work.  IOM  Research  Project:  P937/99,  May  2011,  IOM, 
Institute of Occupational Medicine, Edinburgh, UK. 

124 

 
 
 
                                                            
measured by BAuA 2014123 and 90%  exposure concentration  measured in France from 
2004 – 2006124. 

Table 56: Estimated EU workers exposed to different exposure concentrations of beryllium: 

EU/USA data set and BeST exposure concentrations 

Sector 

< 0.06 
μg/m3 

0.06 μg/m3 
– 
 0.2 μg/m3 

0.2 μg/m3 
–  
1 μg/m3 

1 μg/m3 
–  
2 μg/m3 

1,043 

2,820 

817 

418 

Foundries 
Metal 

3,989 

10,780 

3,123 

1,599 

263 
134 

745 

114 

392 

145 

2,606 

1,858 

2,041 

7,044 

1,455 

5,021 

513 
261 

655 
333 

1,771 
901 

fabrication  
Transportation 
ICT 
Specialist 
manufacturers  
Medical 
devices 
Glass 
Total (seven 
sectors) 
Laboratories 
Recycling 
Total excl 
construction 
Construction 
Total incl 
construction 
% (same for 
all sectors) 
Source: RPA, BAuA MEGA data125, Vincent et al (2009)126 

335 
100 

907 
269 

263 
78 

10,629 

28,729 

11,064 

29,905 

14,639 

16,480 

44,544 

12,906 

20.5% 

55.3% 

16.0% 

8,324 

8,665 

4,241 

5,416 

1,045 

58 

4,262 

135 
40 

4,437 

2,172 

6,609 

8.2% 

Total  
workers 
exposed in 
sector 

5,099 

Exposure 
95 
percentile 
MEGA 
1.05 

Exposure 
90 
percentile 
France 

16.06 

19,491 

3,202 
1,628 

9,079 

12,737 

709 

51,945 

1,639 
487 

54,071 

26,469 

80,540 

100% 

0.228 

0.554 
0.512 

0.512 

0.512 

2.78 

- 

0.512 
0.19 

- 

2.52 

- 

- 

0.6 

0.015 
10.44 

- 

0.5 

- 

- 

- 
0.1 

- 

- 

- 

- 

Table 57: Estimated EU workers exposed to different exposure concentrations of beryllium: 

EU/USA data set and US-OSHA exposure concentrations 
2 
μg/m3 
– 4 
μg/m3 
249 
(5%) 
159 

Total 
workers 
exposed 
in sector 
5,099 
(100%) 
19,491 

0.4 
μg/m3 
– 1 
μg/m3 
1,039 
(20%) 
1,382 

1 
μg/m3 
– 2 
μg/m3 
497 
(10%) 
405 

0.2 μg 
/m3 - 
0.4 
μg/m3 
839 
(16%) 
1,640 

423 
(8%) 
365 

> 4 
μg/m3 

< 0.2 
μg/m3 

2,052 
(40%) 
15,540 

Exposure
95% 
MEGA 

Exposure 
90% 
France 

1.05 

16.06 

0.228 

0.6 

Sector 

Foundries 

Metal 

123  BAuA.Substance  Evaluation  Report-  Beryllium.  http://echa.europa.eu/documents/10162/a99d2dc4-

124  Vincent 

c217-4024-b6ed-9c7262e2ba56 
al.Occupational 
https://www.ncbi.nlm.nih.gov/pubmed/19372137 

exposure 

et 

to 

beryllium 

in 

French 

enterprises 

2009 

125  BAuA.  SubstanceEvaluation  Report-  Beryllium.  http://echa.europa.eu/documents/10162/a99d2dc4-
c217-4024-b6ed-9c7262e2ba56  IFA  (2013):  MEGA-Auswertungen  zur  Erstellung  von  REACH- 
Expositionsszenarien für Beryllium und seine Verbindungen. 2014 

126  Vincent 

al.  Occupational 
https://www.ncbi.nlm.nih.gov/pubmed/19372137  

exposure 

et 

to 

beryllium 

in  French 

enterprises 

2009 

125 

 
 
 
 
                                                            
 
fabrication  
Transportatio
n 
ICT 

Specialist 
manufacturers  
Medical 
devices 
Glass 

Total (seven 
sectors) 
Laboratories 

Recycling 

Total 
excluding 
construction 
Construction 

(80%) 
1,948 
(61%) 
1,213 
(75%) 
8,133 
(90%) 
7,176 
(56%) 
378 
(53%) 
36,440 
(70%) 
1,150 
(70%) 
342 
(70%) 

(8%) 
429 
(13%) 
162 
(10%) 
398 
(4%) 
1,794 
(14%) 
104 
(15%) 
5,366 
(10%) 
169 
(10%) 
50 
(10%) 

(7%) 
472 
(15%) 
172 
(11%) 
332 
(4%) 
1,973 
(15%) 
161 
(23%) 
5,531 
(11%) 
175 
(11%) 
52 
(11%) 

37,931 
(70%) 

5,586 
(10%) 

5,757 
(11%) 

18,568 
 (70%) 

2,734  
(10%) 

2,818 
(11%) 

Source: RPA (2018) 

(2%) 
271 
(8%) 
54 
(3%) 
111 
(1%) 
1,435 
(11%) 
42 
(6%) 
2,815 
(5%) 
89 
(5%) 
26 
(5%) 

2,930 
(5%) 

1,434 
(5%) 

(1%) 
19 
(1%) 
16 
(1%) 
40 
(0%) 
0 
(0%) 
14 
(2%) 
497 
(1%) 
16 
(1%) 
5 
(1%) 

517 
(1%) 

253 
(1%) 

(2%) 
62 
(2%) 
12 
(1%) 
65 
(1%) 
359 
(3%) 
8 
(1%) 
1,294 
(2%) 
41 
(2%) 
12 
(2%) 

1,347 
(2%) 

659 
(2%) 

(100%) 
3,202 
(100%) 
1,628 
(100%) 
9,079 
(100%) 
12,737 
(100%) 
709 
(100%) 
51,945 
(100%) 

1,639 

487 

0.554 

0.015 

0.512 

10.44 

0.512 

NA 

0.512 

0.5 

2.78 

NA 

- 

NA 

NA 

- 

NA 

NA 

54,071 

- 

- 

26,469 

NA 

NA 

The data in the tables above have different exposure ranges. The following comparisons 
between the two can only be made for the first seven sectors as the US-OSHA data only 
covers seven sectors, however, construction would need to be excluded as the numbers 
distort  the  analysis  and  the  figures  for  laboratories  and recycling  are  small.   The  BeST 
distribution predicts that 4,262 are exposed to over 1 μg/m3 in the EU compared with the 
US-OSHA  distribution  which  predicts  4,606  are  exposed.  Given  the  totally  different 
methods  of  achieving  these  numbers,  this  is  remarkably  similar.  The  US-OSHA 
distribution also predicts that 1,791 workers are exposed to over 2 μg/m3, which is at or 
above the OEL for nearly all Member States. These figures are similar to the IOM report 
predictions  of  3,000  workers  exposed  to  higher  levels  of  beryllium  and  under  10% 
exposed to 2 μg/m3  or  more.  Both the BeST and US-OSHA  predictions are for 8%  of 
workers being exposed to 2 μg/m3 or more. 
At the lower end of the scale, the numbers of workers exposed to less than 0.2 μg/m3 are 
39,358 (66%) for the BeST predictions and 36,440 (70%) for the US-OSHA predictions, 
again they are similar. 

The different distributions (BeST and US-OSHA) applied to the predictions for all three 
methods are plotted for each sector in turn in the tables above. They show that foundries 
are  the  sector  where  workers  are  exposed  to  the  highest  levels  of  beryllium:  13%  are 
predicted to be working at over 2 μg/m3. 

Arsenic acid and its salts, as well as inorganic arsenic compounds in the scope of the 
CMD 

Relevant sectors, uses and activities 

This  section  provides  an  overview  of  the  sectors,  uses,  and  activities  in  which 
occupational exposure to arsenic acid, its salts and inorganic arsenic compounds is likely 
to take place.  

126 

 
 
 
Occupational  exposure  to  inorganic  arsenic  compounds  may  take  place  in  a  number  of 
processes  including  production  and  intentional  use  of  the  substances  within  the  scope; 
formation of the substances by processes involving alloys with arsenic metal and thermal 
processes where arsenic is present as unintentional impurity in raw materials. Arsenic is 
naturally  present  as  impurity  in  ores,  fossil  fuels,  soil,  plant  material,  etc.  and  may  be 
released to the air by thermal processing/combustion of these materials.  

Furthermore, arsenic compounds would be present in dust formed by the processes. The 
number of workers potentially exposed to inorganic arsenic in the workplace is high. For 
the study no comprehensive datasets with exposure concentration data across sectors has 
been available. Data have mainly been obtained by stakeholder consultation and from the 
literature.  

For further details on processes for the manufacture of products and other intentional and 
un-intentional  uses  of  arsenic  compounds  and  the  resulting  exposures  refer  to  the  RPA 
(2018) draft final report. The table below includes a general description for each sector.  

Table 58: Inorganic arsenic compounds – sectors and uses 

Sector 
1: Glass sector 

2: Electronics sector 

3: Chemicals sector 

4: Copper sector 

5: Zinc production 
using diarsenic trioxide 
6: Other non-ferrous 
metals  

7: Cross-sector 

Intentional use of substances 
Arsenic acid, diarsenic trioxide 
Diarsenic trioxide 
Unintentional, from former use in glass 
Arsenic acid  

Diarsenic trioxide 
Diarsenic trioxide, arsenic metal 

Diarsenic trioxide, various compounds 

wafers 

Use or activity  
Production of special glass  
Production of domestic glass 
Recycling of glass 
Manufacture  of  copper  foil  for 
printed circuit boards 
Gold plating of circuit boards 
Manufacture  and  use  of  gallium 
arsenide 
and 
semiconductors 
Manufacture 
compounds 
Production of sulphuric acid from 
pyrites  and  residues  from  non-
ferrous production 
Primary copper smelters 
Secondary 
recycling of copper alloys 
Production 
copper-arsenic 
alloys,  production  of  articles  of 
brass and other alloys 
Use in the electrowinning process  Diarsenic trioxide 

Unintentional 

smelters, 

arsenic 

copper 

of 

of 

Unintentional  
Unintentional (dross, slags, etc.); arsenic 
metal in alloys 
Arsenic metal in alloys 

Unintentional  

Arsenic metal in alloys 

Diarsenic trioxide 

Arsenic metal in alloys; unintentional 

lead-arsenic  alloys 

Nickel,  zinc,  lead,  precious  metal 
smelters 
Production  of  alloys  of  lead  and 
tin with arsenic 
Use  of 
to 
produce  batteries,  ammunition, 
etc.  
Manufacture  of  ultrapure  arsenic 
metal 
Various  welding 
processes. 
Plasma  cutting  and  other  thermal 
cutting processes. 

127 

 
 
 
 
 
and 

Use or activity  
Pig  iron  production  (sinter  plants 
and pelletization plants) 
Maintenance  of  boilers 
equipment for flue gas treatment 
Mining operations and production 
of concentrates 
Other metalworking processes 
Shredding  and  dismantling  of 
WEEE 
Maintenance  and  recycling  of 
wood 
arsenic 
treated  with 
compounds 
Various 
standards in laboratories 
Reclamation of CCA wood 

analytical 

uses 

as 

Intentional use of substances 
Unintentional  

Unintentional  

Unintentional  

arsenide, 

Arsenic metal in alloys; unintentional 
Gallium 
compounds in semiconductors 
Various arsenic compounds use in CCA 
treated wood 

various 

As 

Various compounds 

Former use of arsenic compounds 

Sector 
8: Ferrous metals 

9: Power sector 

10: Other 

Source: RPA (2018) 

  Glass sector 

Production of glass is together with the electrowinning of zinc the major application of 
arsenic  compounds.  Two  arsenic  compounds  are  used  in  significant  quantities:  arsenic 
acid and diarsenic trioxide. Both substances are used as fining agents in the production of 
glass. The substances can, according to Glass Alliance Europe, be used interchangeably 
in the glass sector. A detailed description of the processes and uses of arsenic compounds 
in  the  manufacture  of  special  glass,  domestic  glass  and  glass  insulation  materials  and 
recycling of glass is available in RPA (2018). 

  Electronics sector 
Arsenic  compounds  are  used  for  various  applications  in  the  manufacture  of  electronic 
components and printed circuit boards. Exposure by inhalation may take place by the use 
of  the  substances  for  the  manufacture  of  the  components,  whereas  the  exposure  by  the 
later  use  of  the  components  and  printed  circuit  boards  for  production  of  electronics  is 
considered insignificant. 

For  the  detailed  description  of  the  processes  and  uses  of  arsenic  compounds  in  the 
manufacture  of  copper  foils,  gold  plating  of  circuit  boards  and  the  description  of  the 
supply chain and processes in the manufacture of semiconductors (RPA (2018)).  

  Chemicals sector 

Diarsenic  trioxide  and  arsenic  acid  is  manufactured  as  a  by-product  by  two  EU 
companies by recovery from waste products from the production of non-ferrous metals.  

About  60  tonnes  was  used  in  the  chemicals  sector  for  production  of  other  arsenic 
chemicals  and  the  ultra-pure  arsenic  metal  (ECHA,  2016).  The  available  information 
indicates that the majority is used for the manufacture of ultra-pure arsenic metal. As this 
application is a use as intermediate, it is not subject to authorisation under REACH.  

No  detailed  information  on  exposure  to  arsenic  from  the  production  of  other  arsenic 
compounds is available. Some production of arsenic compounds in volumes below the 1 
t/year probably takes place by some manufacturers of laboratory standards and specialty 
chemicals.  

128 

 
 
 
 
 
Two arsenic salts, calcium arsenate and trileaddiarsenate are used as intermediates in the 
"manufacture of basic metals, including alloys" according to their REACH registrations. 
The  same  substances  may  be  present  in  flue  gas  treatment  residues  from  pig-iron 
production  or  non-ferrous  metal  production  (see  description  below)  -  the  majority  of 
these residues seem to be disposed of to landfill, but a part is used as intermediate in the 
production  of  arsenic  compounds  or  arsenic  metal  in  the  non-ferrous  industry.  The 
possible  exposure  by  use  of  the  substances  as  intermediates  is  covered  by  "other  non-
ferrous metals". 

The industrial use of diarsenic trioxide as a processing aid to activate the absorption and 
desorption  of  carbon  dioxide  was  granted  authorisation  and  approved  by  RAC  in  2015 
for  a  period  of  22  months.  Within  this  period,  the  use  of  diarsenic  trioxide  for  this 
particular process should have been phased out and replaced by an alternative (vanadium 
pentaoxide). 

Available information  indicates that occupational exposure to arsenic would  potentially 
take  place  when  sulphuric  acid  is  produced  in  the  non-ferrous  metal  sector,  and  in 
particular in the copper sector, and when it is produced from pyrite. For more details see 
RPA (2018). 

  Copper sector 

The copper sector has been identified by the stakeholder consultation as a sector where 
exposure  to  arsenic  is  of  major  concern  and  a  sector  that  could  be  impacted  by 
establishing an OEL.  

Exposure  to  arsenic  in  the  copper  sector  could  basically  take  place  by  three  activities, 
which will be described separately: 

  Primary copper production; 

  Secondary copper production where arsenic may originate from recycled copper-

arsenic alloys or arsenic impurities in the recycled materials; 

  Production and casting of copper-arsenic alloys. 

As metallic arsenic is not within the scope of the assessed OEL, exposure to dust of pure 
metallic arsenic or arsenic in alloys would not lead to exposure within the scope, and the 
assessment focuses on processes where inorganic arsenic compounds are formed which 
could lead to exposure.  

Many  of  the  processes  described  below  for  the  primary  copper  sector  where  exposure 
could take place would be quite the same for other non-ferrous metals, but the exposure 
levels would in general be lower as the arsenic content of such ores and concentrates is 
generally lower.  

Primary copper production 

The main sector affected by arsenic in raw materials is the primary copper sector, where 
arsenic  in  the  ores  is  a  major  issue  both  with  regard  to  occupational  exposure  and 
environmental releases.  

Arsenic  in  mined  copper  concentrates  is  increasing,  which  is  a  major  concern  for  the 
copper sector. According to Rohner et al. (2017) from 2000 to 2017 the average arsenic 
content in world copper concentrates increased from 0.13 to 0.22 %.  

129 

 
 
Based on information obtained from the stakeholder consultation it is estimated that the 
total  content of arsenic in concentrates  used  in  primary copper production in  the EU is 
likely in the range of 3 000-6 000 t/year. The turnover of arsenic in copper production is 
thus  several  times  the  total  intentional  consumption  of  arsenic  compounds  for  all 
applications in the EU. The range indicated would correspond to an average content of 
the  concentrate  of  0.05  to  0.10%  if  it  is  assumed  that  the  copper  content  of  the 
concentrates  is  30%  (typical  content).  Primary  nickel  production,  with  the  potential 
exposure  of arsenic compounds to  workers, takes place in one facility in the EU in the 
same building and workers involved in nickel smelting are consequently included in the 
exposed workforce for primary copper smelting. 

A schematic overview and a detailed description of primary copper smelter operations is 
available in RPA (2018). 

Secondary copper production  

In secondary smelting, the feed material is scrap either loaded into a smelting furnace, for 
example loaded through a vertical shaft into a blast furnace below, or, if sufficiently pure, 
loaded directly into a converter or anode furnace. 

The sources of arsenic from the secondary copper production are different as in primary 
copper production: mainly arsenic present as alloying element in some copper alloys and 
arsenic in some residues from other industrial processes.  

Copper alloys 

It is estimated that about 300 t/year of metallic arsenic is used for production of copper 
alloys. Arsenic metal is not within the scope of the assessed OEL, but arsenic oxides may 
be formed by the melting of the alloys. In the process, the arsenics can be released e.g. in 
fumes, dusts and skimmings. 

The first step in the manufacture of the alloys is the manufacture of copper-based master 
alloys,  produced  by  a  limited  number  of  companies  specialised  in  the  manufacture  of 
such alloys. A copper-arsenic master alloy typically contain 30% arsenic and 70% copper 
(CuAs30).  

The master alloys are used by a large number of manufacturers of copper alloys where 
the  master  alloy  is  melted  with  the  other  alloying  components.  As  an  example,  a  brass 
alloy  suited  for  the  use  in  drinking  water  applications  could  typically  contain  63% 
copper, 0.2% lead, 0.1% arsenic and the remaining part zinc. A large number of workers 
may be exposed to low levels of arsenic by the further machining of the alloys, but as this 
exposure would be to metallic arsenic, it is not considered to be within the scope of this 
assessment. RPA (2018) 

  Zinc production using diarsenic trioxide 

Exposure  to  inorganic  arsenic  compounds  in  the  zinc  industry  can  either  be  due  to  the 
intentional use of arsenic compounds in the electrowinning process or due to low levels 
of arsenic in the raw materials for the production. The exposure from the intentional use 
of arsenic compounds taking place in two facilities is described in this section whilst the 
exposure  to  arsenic  in  the  ores,  potentially  taking  place  in  more  facilities,  is  described 
together  with  exposure  to  arsenic  in  ores  used  in  the  manufacture  of  other  nonferrous 
metals.  

130 

 
 
The  production  of  zinc  is  together  with  the  manufacture  of  glass  the  major  application 
area  for  arsenic  compounds.  The  application  is  subject  to  authorisation  under  REACH. 
Details  on  the  two  application  documents  and  RAC  decisions  are  presented  in  RPA 
(2018). 

  Other non-ferrous metals 

Occupational  exposure to arsenic may take  place by a number of processes in the non-
ferrous sector. The detailed assessment of the effects of the proposed OEL for the sectors 
'Manufacture of ultrapure arsenic metal,' lead alloys with arsenic' (with its main uses in 
battery grids where trace quantities of arsenic are added to lead/antimony grid alloys used 
in lead-acid batteries, ammunition, where the addition of arsenic (0.5–2%) improves the 
sphericity of lead shot and cable sheathing (not confirmed information  from literature). 
RPA (2018). 

Primary lead, zinc and cadmium production 

Arsenic is naturally present as impurity in ores, fossil fuels, soil, plant material, etc. and 
may  be  released  to  the  air  by  thermal  processing/combustion  of  these  materials. 
Furthermore, arsenic compounds would be present in dust formed by the processes.  

Compared to primary copper production, arsenic is less an issue in primary lead and zinc 
production because the arsenic content of the concentrates is lower.  

Precious metals and other non-ferrous metals  

Gold,  silver  and  platinum  group  metals  and  other  metals  such  as  selenium,  cobalt,  and 
germanium  are  produced  either  from  ore  concentrates,  from  waste  products  from  other 
non-ferrous metal production or from scrap e.g. from electronic products. Arsenic may be 
present in all the raw materials e.g. in the form of nickel arsenide, but in particular large 
quantities  are  processed  with  waste  products  from  other  non-ferrous  metal  production. 
Some of these activities are undertaken at sites manufacturing primary copper and are in 
these instances included in the description for this sector. 

Processes  differ  between  the  companies,  but  the  following  worker  exposure  scenarios 
have been indicated in responses to the stakeholder consultation:  

  Transportation and unloading of raw materials 

  Sampling of raw materials 

  Sampling as part of process control 

  Smelting of raw materials 

  Refining of final products 

  Packaging final products (if the end products include arsenic compounds) 

  Maintenance operations 

  Welding, plasma cutting and similar processes 

Exposure to arsenic by welding are often mentioned in general introductions to exposure 
to  hazardous  substances  in  welding.  Very  limited  data,  however,  has  been  identified 
describing the sources of arsenic in the welding processes and the differences in exposure 

131 

 
 
levels between different processes. Data from the German MEGA database demonstrates 
exposure to arsenic in different welding and thermal cutting processes.  

  Ferrous basic metal production 

The  CAREX  Canada  (2017)  estimates  that  <5%  of  the  workers  in  the  "Iron  and  steel 
mills  and  ferroalloy  manufacturing"  are  potentially  exposed  to  arsenic.  Likewise,  the 
European  CAREX  database  (form  1997)  estimates  that  some  7 000  workers  may  be 
exposed in the iron and steel basic industries. None of the databases include actual data 
on exposure levels.  

The BAT document for iron and steel production (JRC, 2013b) describes that bleed water 
from  scrubbers  from  palletisation  plants  (first  step  in  the  pig  iron  production  in  some 
plants;  in  others  the  first  step  is  sinter  plants)  in  some  cases  is  treated  in  an  "arsenic 
removal plant". Some exposure could take place by maintenance of the arsenic removal 
plant and by handling the filter cake. Furthermore, maintenance and cleaning works on 
electrostatic  precipitators  and  bag  filters  on  sinter  plants,  palletisation  plants  and  blast 
furnaces  may  likely  lead  to  some  exposure  to  arsenic  as  has  been  demonstrated  by 
maintenance of similar filters in some coal power plants.  

  Power sector 

Workers in coal and oil-shale powered power plants may be exposed to arsenic in fly ash 
during cleaning. Fly ash contains arsenic and a number of other heavy metals which the 
workers are exposed to e.g. by cleaning and maintenance.  

During  coal  combustion,  arsenic  readily  oxidizes  to  form  arsenic  oxide  vapour  which 
combines with calcium oxide and condenses on the surface of fly ash (RAC, 2017). Solid 
by-products of the combustion process, including fly ash and bottom ash, are major sinks 
for arsenic. Workers in power plants may first of all be exposed to arsenic found in the 
fly  ash  during  cleaning  of  fabric  filters  and  boilers.  Arsenic  in  coals  are  analysed 
periodically  together  with  other  element  and  the  arsenic  content  varies  considerably. 
Occupational exposure to arsenic has not been measured and is not considered to be of 
specific concern. Workers involved in  cleaning and maintenance in  any case wear  full-
face respirators. 

  Other sectors 

Mining sector 

The main activity where exposure to arsenic may take place is expected to be mining of 
copper  because  copper  concentrates  compared  to  other  concentrates  contain  relatively 
high concentrations of arsenic. By handling of copper concentrates in the primary copper 
smelters, significant workplace concentrations, e.g. by sampling of raw materials and by 
maintenance  procedures,  are  reported  and  workers  would  typically  use  RPE  for  these 
processes. Similar work processes may be expected to take place by the manufacture of 
arsenic-containing concentrates in mining sites.  

Other processes in the metal industry 

Data from the German MEGA database indicates that exposure to arsenic may take place 
by various processes in the metal industry such as soldering, casting/melting and similar 
process, dry sanding, and various machining processes. As details are not provided it is 
not clear if the exposure is due to intentional use of arsenic in e.g. copper alloys or due to 

132 

 
 
low  levels  of  arsenic  as  unintentional  trace  element  in  e.g.  sandblasting  and  abrasive 
materials.  

Wood preservatives and preserved wood 

Historically,  diarsenicpentaoxide  was  used  in  chromated  copper  arsenate  (CCA)  wood 
preservatives. The substance is subject to authorisation, but no companies have applied 
for authorisation. 

The use of CCA solutions in the preservation of timber and import of CCA treated timber 
is  regulated  by  the  Biocidal  Product  Regulation  and  is  no  longer  permitted,  its  use  is 
further  restricted  under  Annex  XVII  to  the  REACH  Regulation.  In  practice  the 
Regulation applies to reclaimed timber and included some derogations for wood treated 
with CCA solution placed on the market for professional and industrial use, provided that 
the  structural  integrity  of  the  wood  is  required  for  human  or  livestock  safety  and  skin 
contact by the general public during its service life is unlikely. RAC (2017) notes that the 
use of CCA to preserve wood has effectively ceased in the EU, as has the import of CCA 
treated timber.  However,  this  leaves  a  considerable legacy  of  treated timber  still in  use 
with implications for occupational exposure in relation to waste treatment and recycling 
for the future (RAC, 2017). Workers may be exposed to arsenic by recycling of wood for 
exempted purposes. Potentially, a large number of workers may occasionally be exposed 
to low levels of arsenic in dust from the wood.  

Taxidermists and preservators 

Traditionally  diarsenic  trioxide  has  been  used  by  taxidermists  for  the  preservation  of 
animals. Diarsenic trioxide was the most used biocidal product for 'dry' preservation. The 
exposure for e.g. museum workers today are considered low and are not further assessed.  

Dismantling and recycling of waste of electrical and electronic equipment 

Arsenic  is  intentionally  used  in  some  electronic  components  and  some  exposure  to 
arsenic  by  dismantling  and  recycling  of  electronics  may  take  place,  e.g.  exposure  to 
cadmium  and  arsenic  compounds  is  to  be  expected,  in  particular  with  recycling  of  not 
silicon based photovoltaic modules.  

Laboratory use 

Various  arsenic  compounds  are  applied  for  laboratory  use.  Besides  the  use  of  the 
compounds  as  analytical  standards,  apparently  mainly  organic  arsenic  compounds  have 
specific  applications  in  chromatography,  separations,  and  environmental  chemistry, 
materials  science  in  polymers,  proton-exchange  membranes,  and  optical  materials.  The 
exposure in laboratories by use of inorganic arsenic compounds as analytical standards is 
considered insignificant. 

Estimated EU workers exposed 

The estimated number of workers exposed to  inorganic arsenic compounds by sector is 
summarised in Table 9. The table distinguishes between two groups: 

  Workers  for  which  available  data  shows  that  they  are  exposed  at  higher  levels  as 
demonstrated by measurements, modelling or from comparison to similar processes.  

133 

 
 
 
  Other  workers  which  may  potentially  be  occupationally  exposed.  The  latter  group 
either  works  in  sectors  and  with  processes  where  arsenic  may  be  present  in  raw 
materials at considered relatively low levels, or they work in high-exposure sectors (as 
the  copper  sector),  but  likely  are  not  routinely  working  with  the  high-exposure 
processes covered by the monitoring of workplace concentrations.  

The  estimated  total  for  the  EU28  for  the  two  groups  of  exposed  workers  is  25,300  – 
116,200. For comparison the total of 86,000 is estimated for the mid 1990's for the EU15 
in the CAREX database (when applications phased out or beyond the scope of the current 
study is subtracted the total in the CAREX database).  

There is a probability that the numbers of the first group are significantly underestimated 
as they include only a group of workers for which data is available. There can be more 
workers exposed at higher levels for whom data is not available. 

134 

 
 
Table 59: Inorganic arsenic compounds – exposed workforce 

Sector 

Use/operation 

1: Glass sector 

Fining agent in special glass 

Fining agent in domestic glass 

wafers 

of 
not 

Recycling of glass 
Manufacture of copper foils  
Gold plating of circuit boards 
Manufacture  and  use  of  gallium 
arsenide 
and 
semiconductors 
Manufacture 
compounds, 
elsewhere 
Production of sulphuric acid (from 
pyrite  and  by-product  from  other 
than copper production) 
Primary  copper  smelters 
prod of sulphuric acid) 
Secondary copper smelters 
Production  and  use  of  copper-
arsenic alloys 

arsenic 
included 

(incl. 

At exposure level as 
demonstrated by 
measurements or 
modelling 

No of workers 
potentially 
exposed at 
lower levels ** 

Sites 

10-20 

0-20 

30-50 
1 
1 

Exposed 
workers * 

300-500 
0-200  

nno use confirmed 

- 
48 
25 

1,000-3,500 

1,000-3,000 
- 
- 

18-25 

150-300 

1,000-5,000 

2-10 

- 

20-200 

15 

7 

8 

10-30 

30-170 

200-600 

3,200 

2,000-3,000 
50-200 
(masters alloy) 

2,000-4,000 

Purification in zinc electrowinning 

2 

90 

- 

Primary  production  of  lead,  zinc, 
precious metals, ultrapure arsenic 
Production of alloys of lead and tin 
with arsenic 
Use  of 
to 
produce batteries, ammunition, etc. 
Various welding processes. Plasma 
cutting  and  other  thermal  cutting 
processes.  

lead-arsenic  alloys 

Pig  iron  production  (sinter  plants 
and palletisation plants) 

Maintenance  operations  in  coal 
and oil-shale power plants 
Mining  operations  and  production 
of concentrates  
Other metalworking processes  
Shredding  and  dismantling  of 
WEEE 
Reclamation of CCA wood 
Laboratory use  

50-200 

300-1,000 

- 

- 

5,000-20,000 

>500 

1,000-4,000 

- 

40 

93 

10-30 

>500 

20 

- 
- 

500-1,500 

600-6,000 

50-500 

200-600  
(copper) 
- 

- 

- 
- 

500-2,500 

500-2,000 

5,000-50,000 

1,000-3,000 

20-2,000 
Insignificant 

7,900-15,300 

18,000-102,000 

TOTAL 

(rounded) 
Source: RPA (2018) 

135 

2: Electronics 
sector 

3: Chemicals 
sector 

4: Copper 
sector 

5: Zinc 
production 
using diarsenic 
trioxide 

6: Other non-
ferrous metals  

7: Cross-sector 

8: Ferrous base 
metals 
production 

9: Power sector 

10: Other  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Formaldehyde 

Relevant sectors, uses and activities 

In  its  pure  monomeric  form,  formaldehyde  is  somewhat  unstable  and,  as  such,  it  is 
usually converted into a variety of forms for consumer or commercial use, for example 
into  formaldehyde-based  resins  and  polymeric  materials,  such  as  polyurethane  (RPA, 
2006). 

Formaldehyde  is  used  in  a  wide  variety  of  sectors.    According  to  the  ECHA  substance 
information  portal,  formaldehyde  is  used  in:  adhesives  and  sealants;  coating  products; 
polymers;  biocides;  laboratory  chemicals;  polishes  and  waxes;  fuels;  washing  and 
cleaning products; cosmetics and personal care products.  Formaldehyde is also used in 
the  manufacturing  of  leather  and  fur,  pulp,  paper  and  paper  products,  textile  and  wood 
and wood products and is used in building and construction work (ECHA, 2017a).  

Formaldehyde is used for tissue preservation in embalming fluids and as a disinfectant in 
pathology departments and autopsy rooms, usually in the form of formalin (i.e. mixture 
of formaldehyde, water, and methyl alcohol).  Formaldehyde can also be used in the form 
of  a  polymerized  solid  -  paraformaldehyde,  which  tends  to  be  favoured  in  industrial 
applications in plants that are located at long distances from formaldehyde manufacturing 
plants due to its lighter weight and lower shipping costs (IARC, 2012).   

The breakdown of formaldehyde use in the EU is as follows from information supplied 
by Formacare: 

41% is used in urea formaldehyde; 

9% is used in phenolic resins; 

7% is used for melamine formaldehyde; 

11% is used in polyols; 

8% is used for methylene dianiline (MDA); 

7% is used in polyacetal resins; and 

17% for other uses. 

The most relevant sectors/uses of formaldehyde from literature review and consultation 
are discussed in the following sectors. 

  Agriculture, Forestry and Fishing (NACE Code A) 

Formaldehyde is used in slow release fertilisers and in urea treated with formaldehyde as 
a stabiliser in fertiliser manufacturing.  Further information about this use is discussed in 
the manufacturing of chemicals and chemical products section. 

Formaldehyde  has  been  identified  as  being  used  in  fish  farms  which  are  stocked  with 
brown  and  rainbow  trout.    It  used  in  the  form  of  formalin  with  a  concentration  of  200 
ppm and is mainly used in ponds on an infrequent basis dependent on weather conditions 
(<10 times per year from consultation).  It is used to treat fungal infection and growth in 
ponds stocked with brown and rainbow trout and may be used to some extent in all trout 
fish farms in Ireland.  From consultation, a limited number of people are involved in the 
formaldehyde treatment. 

136 

 
 
 
Manufacturing of food products (NACE Code C10) 

Formaldehyde is used in the manufacturing of food products as a bacteriostatic agent, for 
example  in  foods  such  as  cheese,  in  the  preservation  of  dried  foods,  for  disinfecting 
containers, in the preservation of fish and certain oils and foods, and in the modification 
of starch for cold swelling (OECD, 2017). 

Formaldehyde is also used in sugar beet processing, where it is used as a biocidal agent 
in saccharose extraction from beetroots (ANSES, 2016). 

  Manufacture of textiles (NACE Code C13) 

In the manufacture of textiles, formaldehyde based resins are used.  These resins are used 
to  bind  dyes  and  pigments  to  fabrics  and  also  to  prevent  colours  from  running  when 
clothes are washed.  Urea formaldehyde (UF) and melamine formaldehyde (MF) resins 
can also be used in textile manufacturing for making clothes stain and wrinkle resistance 
(Formacare, 2014a). 

Operations  where  exposure  could  occur  are  during  the  manufacturing  process,  which 
includes  spraying,  processing,  mixing/blending,  assembly,  dipping/pouring  and 
cutting/sanding.  This is further discussed in Section 3.5. 

  Manufacture of leather and related products (NACE Code C15) 

In  the  REACH  dossier,  the  use  of  formaldehyde  in  leather  tanning  is  listed  (ECHA, 
2017b).    Operations  where  exposure  could  occur  are  during  the  manufacturing  process 
which  includes  spraying,  processing,  mixing/blending,  assembly,  dipping/pouring  and 
cutting/sanding.  This is discussed in more detail in Section 3.5. 

  Manufacture  of  wood  and  products  of  wood  and  cork;  except  furniture  (NACE 

Code C16) 

The  majority  of  formaldehyde  produced  in  the  EU  is  used  to  manufacture  resins.    The 
primary  use  of  is  in  the  production  of  urea-formaldehyde  resins  (50%  of  EU 
consumption),  melamine  formaldehyde  resins  (10%  of  EU  consumption)  and  phenol 
formaldehyde resins (12% of EU consumption). Polyacetyl resins (POM) account for 8% 
of  the  EU  formaldehyde  market  and  is  a  growing  market  as  POMs  are  self-lubricating 
thermoplastics for replacing metal components and are used in a variety of sectors such 
as gears, housings and bearings.   

The  primary  use  of  formaldehyde  based  resins  is  in  the  manufacture  of  wood  based 
panels  (TNO  Triskelion  B.V.  and  RPA,  2013).    In  particular,  urea-formaldehyde  (UF) 
resin  and  phenol  formaldehyde  (PF)  resin  are  used  in  the  manufacture  of  wood  and 
products of wood and cork.  The primary application of the resins is as a “glue resin” in 
wood panels and wooden plates.    

For these uses, emission standards are in place in the EU to limit formaldehyde exposure.  
Two standards exist for wood-based products:  emission class E1 and emission class E2.  
In  E1  boards,  formaldehyde  emissions  are  less  than  0.1  ppm;  and  for  E2  boards 
formaldehyde  emissions  are  between  0.1  and  0.3  ppm  (Health  and  Safety  Executive, 
undated).   

Emission  class  E1  is  the  class  that  applies  to  panel  production  (ANSES,  2016). 
Operations  where  exposure  could  occur  are  during  panel  production  (which  includes 

137 

 
 
loading/unloading;  process  operations; 
weighing; mixing and filling) and also during in situ use downstream users.   

line  operations;  sorting/packing; 

testing; 

  Manufacture of paper and paper products (NACE Code C17) 

Formaldehyde  is  used  in  the  manufacture  of  paper  and  paper  products.  Urea 
formaldehyde  resin  is  used  for  producing  printer  paper,  craft  paper,  packaging  paper, 
hygienic paper and also paper that requires special security features such as bank notes 
and passports (ANSES, 2016). 

  Manufacture of chemicals and chemical products (NACE Code C20) 

Formaldehyde is also used in the manufacturing of the following chemical products: 

  Fertilisers (NACE Code C20.1):  In slow release fertilisers, formaldehyde is used 
in the preparation of the polymer nutrient but is not present in the final product 
(consultation  with  Fertilizer  Europe).  In  urea,  formaldehyde  is  added  as  a 
stabiliser  which  improves  the  physical  characteristics  of  the  granules  and  also 
avoids  caking  phenomenon  further  down  the  supply  chain  (from  consultation).  
Exposure could  occur during fertiliser production (during cleaning/maintenance, 
sampling and general operation) and in some cases, where formaldehyde is used 
as a stabiliser as this may be partially sprayed over the final product; 

  Methylene dianiline (MDA) and diphenyl methane diisocyanate (MDI), where its 
use is as an intermediate.  MDA is used in the manufacture of MDI which is used 
in  insulation foams,  paints  and coatings, adhesives  for wood panels, automotive 
seats,  bedding  and  mattresses  (8%  of  formaldehyde  in  the  EU  is  used  for  this 
purpose); 

  Paints,  varnishes  and  similar  coatings,  printing  inks  and  mastics  (NACE  Code 
C20.3):  Urea  formaldehyde  resins,  melamine  formaldehyde  resins  and  phenol 
formaldehyde resins) are used  as binding  agents.  The applications of adhesives 
and  coatings  is  also  listed  as  a  use  for  professional  workers  in  the  REACH 
registration dossier (ECHA, 2017b); 

  Soaps  and  detergents,  cleaning  and  polishing  preparations,  perfumes  and  toilet 
preparations  (NACE  Code  C20.4):    Formaldehyde  can  be  used  for  preservation 
applications, household cleaning agents and in nail hardeners amongst others and 
is  present  in  low  concentrations  (Denmark  Environmental  Protection  Agency, 
2014 and Boyer, 2013); and   

  Explosives  (NACE  Code  C20.51):  Formaldehyde  can  also  be  used  in  the 
manufacture  of  explosives  such  as  RDX.  In  this  application,  formaldehyde  is 
reacted  with  ammonia  to  produce  hexamine  (which  can  then  be  used  in 
explosives) (Maxwell, 2004).  

Exposure to formaldehyde during manufacturing of chemicals and chemical products can 
occur  during  process  control  and  sampling,  cleaning/service/repairs  and  filter  changing 
amongst others. 

  Manufacture  of  basic  pharmaceutical  products  and  pharmaceutical  preparations 

(NACE Code C21) 

In pharmaceutical sector, formaldehyde is used in the manufacture of gelatin capsules. It 
is also used as an inactivating agent in vaccines (Pina and Sousa, 2002), where it is used 

138 

 
 
to  inactivate  toxins  from  bacteria  and  viruses.  There  may  be  traces  of  formaldehyde  in 
the final vaccine, however, this is broken down in water (and most of the vaccine is water 
- Oxford Vaccine Group, 2015). 

  Manufacture of rubber and plastic products (NACE Code C22) 

Formaldehyde has been identified as being used in the manufacture of rubber and plastic 
products in the ANSES (2016) draft document with hexamine (formaldehyde is used as a 
starting material) used as a rubber accelerator (ANSES, 2016). In the study by Clercet al, 
exposure to formaldehyde has been observed in France and Germany in the manufacture 
of  rubber  and  plastic  products  (Clercet  al,  2015).  Phenol  formaldehyde  and  urea 
formaldehyde  resins  are  also  used  in  plastic  fuse  boxes,  knobs  and  switches  (British 
Plastics Federation, 2015). 

Operations where formaldehyde exposure in this sector could occur include in weighing 
and loading; mixing; shaping; vulcanisation/curing; and finishing. 

  Manufacture of fabricated metals, except machinery and equipment (NACE Code 

C25) 

Formaldehyde can be used as a preservative in metal remover fluids, anticorrosive agents 
and  metalworking  agents;  these  products  may  also  release  formaldehyde.  The  use  of 
formaldehyde  releasers  for  metal  working  fluids  is  covered  in  PT  13  of  the  biocidal 
products  regulation  (RIVM,  2015).  Exposure  can  occur  during  metal  finishing  and 
plating.  Exposure can also occur in foundries, as when sand is hardened, formaldehyde 
based resins are used. 

  Manufacture of electrical equipment (NACE Code C27) 

Polyoxymethylene (also called Polyacetal) resins  are formaldehyde polymers which are 
used in powder injection moulding technology (Antoun et al, 2013).  POM resins are also 
used in the manufacture of electrical and electronic appliance parts (moulding). 

  Manufacture of machinery and equipment (NACE Code C28) 

Phenol formaldehyde resin is used in the production of abrasive wheels. 

  Manufacture of motor vehicles, trailers and semi-trailers (NACE Code C29) 

Formaldehyde  based  resins  are  used  in  many  automotive  applications  and  these  are 
described in the below table. 

139 

 
 
Table 60: Formaldehyde resins used in automotive applications 

Formaldehyde resin 

Phenol formaldehyde 

Properties for application 
High  moisture  resistance,  high  chemical 
resistance, and high thermal resistance 

Melamine formaldehyde  Withstand  high  temperatures,  fast  curing, 

Polyoxymethylene 

and excellent chemical resistance 
Gasoline 
lubricant 
resistance 
properties (main use in the manufacture of 
fuel pumps) 

and 

Application 
Engine  parts,  transmission  parts, 
brake parts, brake pads, clutches, 
and decorative laminates 
Surface  coatings  and  decorative 
laminates 
Automatic transmission parts, car 
heater  plates,  gear 
selectors, 
steering  column  shear  pin  parts, 
tyre  valve 
links, 
suspension 
stems,  electrical  switch  parts, 
system 
light 
components, 
car 
fan 
ventilation  grille,  truck  release 
levers, 
door 
catches,  window  cranks,  control 
switches  and  instrument  knobs, 
gear  selectors,  plastic  component 
of  seat  belt  systems,  and  locks, 
hooks, 
and 
mirrors 

fasteners, 

handles, 

sockets, 

parts, 

clips 

door 

fuel 

Source:  Formacare (2014):  Formaldehyde in Automotive Applications.  Available at:  
http://www.formacare.org/automotive/ 

Methylene  bis 
(BDO)  and 
Pentaerythritol  (Penta),  in  which  formaldehyde  is  used  as  a  starting  material,  are  also 
used in automotive applications (Formacare, 2014b). 

(dephenyl  di-isocyanate) 

(MDI),  1,4-Butanediol 

  Manufacture of air and spacecraft and related machinery (NACE Code C30.3) 

According  to  Formacare,  formaldehyde  based  resins  are  used  in  the  following  aircraft 
applications (Formacare, 2014c): 

Phenol formaldehyde resins are used in the panelling of aircraft interiors; 

Polyoxymethylene is used in the manufacture of seatbelt plastic components; 

Hexamine is used as an accelerator in rubber tyres; 

Pentaerythritol is used as a lubricant for turbines; and 

MDI is used in aircraft seats. 

  Manufacture of furniture (NACE Code C31) 

Urea formaldehyde and phenol formaldehyde resins are used as “glue resins” in furniture 
manufacturing, which is further discussed in the “Manufacture of wood and products of 
wood and cork; except furniture” section above. 

  Construction of buildings (NACE Code F41) 

Formaldehyde  based  foams  (urea-formaldehyde  and  phenol  formaldehyde)  are  used  as 
building  materials,  insulator  materials,  and  can  also  be  used  as  an  adhesive  in  mineral 
wools  which  have  applications  as  thermal  insulators.    ECHA  lists  the  use  of 
formaldehyde in outdoor use in long life materials with low release rates such as building 

140 

 
 
 
materials  and  in  indoor  use  in  long  life  materials  with  low  release  rates  such  as 
construction materials (ECHA, 2017a). 

  Professional,  Scientific  and  Technical  Activities: 

  Scientific  research  and 

development (NACE Code M72) 

Formaldehyde  is  used  in  the  electrophoresis  (method  to  separate  mixtures  by  size)  of 
RNA  (ThermoFisher  Scientific,  undated  and  Bryant,  1998).    In  the  formaldehyde  gel 
used, formamide (30-60 wt. %) and formaldehyde (10-30 wt. %) is used (ThermoFisher 
Scientific, 2013).  ANSES (2016) also reports that formaldehyde is used as a laboratory 
reagent in control laboratories (ANSES, 2016).   

Formaldehyde is also used in the synthesis of chelating agents and pyridines and is used 
for health research which is further discussed in the higher education sector. 

  Professional,  Scientific  and  Technical  Activities:    Veterinary  activities  (NACE 

Code M75) 

Formaldehyde is used as a veterinary biocidal agent in the poultry sector and is used as a 
fumigant due to its capability to destroy microorganisms on eggs, egg cases, chick boxes 
and hatchery equipment; it is also used as a disinfectant for poultry houses (Association 
of Poultry Processors and Poultry Trade in the EU Countries, 2015).  In a submission to 
an  ECHA  consultation regarding  formaldehyde  as  a  potential  candidate  for  substitution 
under the BPR regulation, the British Poultry Council stated that formaldehyde is used in 
the poultry industry for the following reasons: (British Poultry Council, 2015): 

Formaldehyde is used in hatcheries to stop bacterial contamination in fluff and hatching 
eggs; 

Formaldehyde vapour is easily generated from formalin or paraformaldehyde for use as a 
disinfectant; 

Formaldehyde is efficient for treating buildings; 

There  is  more  penetration  power  down  the  pores  of  eggshells  (gas-phase  disinfectant) 
undergoing fumigation and this process does not damage the eggs or embryos; and 

The use of formaldehyde decreases chick mortality. 

Formaldehyde  is also used  as a disinfectant in greenhouses between crop cycles and in 
foot baths for treating mortellaro disease in dairy cows (LTO Netherlands, undated). The 
use of formaldehyde in fish farms is discussed in the agricultural uses section. 

  Education (NACE Code P85- P85.4. Higher Education) 

Formaldehyde is used as a used as a preservative for specimen and tissue samples which 
is  discussed  in  more  detail  in  the  following  section.  Formaldehyde  is  used  in  the 
following activities (consultation): 

Preparation of fixation solutions (3-4% formaldehyde); 

Fixation of human bodies; 

Storage (preservation of bodies); and 

Teaching for student courses, for example dissection activities. 

141 

 
 
 
  Human  health  and  social  work  activities:  Human  health  activities  (NACE  Code 

Q86) 

Formaldehyde is used for the following applications in the healthcare sector: 

Health services: Cleaning medical equipment, surfaces and environments; used to 
fix  and  maintain  specimens  and  tissue  samples;  used  as  a  tissue  preservative 
(typically 10% concentration) and as an embalming agent; 

Dentistry: Antiseptics and disinfectants, e.g. composite resins replacing amalgam 
and root canal fillings; and 

Schools and universities: Used as a preservative for specimen and tissue samples. 

Operations  where  formaldehyde  exposure  could  occur  include  in  operating  rooms  and 
pathology laboratories and for the uses listed above.  

  Funeral and related activities (NACE S96.03) 

Formaldehyde is used for embalming in funeral homes. From consultation, formaldehyde 
is  used  as  it  cross-links  to  protein  to  stop  bacteria  nourishment.  Exposure  could  occur 
during the embalming process. 

  Other Biocidal Uses 

Formaldehyde  is  also  reportedly  used  in  the  hot  water  treatment  of  flower  bulbs  to 
destroy nematodes in a submission from the Royal General Bulb Growers Association; as 
hot  water  treatment  can  lead  to  basal  rot  and  Legionella  Pneumophila,  formaldehyde 
(0.5%  solution  of  formalin)  is  added  to  the  bath  (Royal  General  Bulb  Growers 
Association, undated) to prevent this from occurring. 

The  relevant  sectors  and  uses  in  which  occupational  exposure  to  formaldehyde  could 
occur are summarised in the following table. 

142 

 
 
Table 61: Formaldehyde exposure sectors 

Sector 
Agriculture,  Forestry  and 
Fishing (NACE Code A) 

Manufacturing 
food 
products (NACE Code C10) 

of 

Form 
Urea-formaldehyde (UF) resin  
Melamine  formaldehyde  (MF) 
resin 
Biocide 

Manufacture 
of 
(NACE Code C13) 

textiles 

Urea-formaldehyde (UF) resin  
Melamine  formaldehyde  (MF) 
resin  
Phenol formaldehyde (PF) resin 

Manufacture  of  leather  and 
related  products 
(NACE 
Code C15) 
Manufacture  of  wood  and 
products  of  wood  and  cork; 
except 
(NACE 
furniture 
Code C16) 
Manufacture  of  paper  and 
paper products (NACE Code 
C17) 
Manufacture  of  chemicals 
products 
and 
(NACE  Code  C20:  C20.1, 
20.2 and 20.4)) 

chemical 

Urea-formaldehyde (UF) resin 

Urea-formaldehyde (UF) resin 

Phenolformaldehyde (PF) resin 

Urea-formaldehyde (UF) resin 

Formaldehyde,  37%  solution, 
49%, 50-55% 

Applications 
Used  as  a  preservative  and  biocide  in: 
Pesticides, fungicides, herbicides, etc. 

for 

curtains, 

synthetic 

Used  in  the  manufacturer  of  sugar 
(saccharose  extraction  from  beetroots); 
food 
as  a  preservative  agent 
additives;  as  a 
reactive 
substance for food contact materials and 
as a surface cleaning agent 
Used as a crease-proof (or anti-wrinkle) 
agent  for:  clothes  and  household  linen 
fabric 
products, 
softeners,  textile  processing  (dyes)  and 
finishing (permanent press);  used  as  an 
antimicrobial  in  medical  textiles  and 
processing 
also 
(formaldehyde-based resins) 
Used in tanneries 
Used  as  a  preservative  for  preventing 
hides from decomposing 
Used  as  a  “glue  resin”  in  wood  panels 
and wooden plates 

carpets, 

textile 

used 

in 

as 

used 

synthesis; 

Used  in  towel  products,  kitchen  rolls, 
napkins,  sack  papers,  labels,  currency, 
maps and filter papers 
Production  of  formaldehyde;  used  in 
a 
fertiliser 
startingmaterial  in  the  production  of 
polyacetalresins 
(polyoxymethylene- 
POM) and paraformaldehyde; used as a 
starting  material  in  the  production  of 
condensed  resins:  Urea-formaldehyde 
(UF);  melamine-formaldehyderesins; 
phenol-formaldehyderesins;  used  as  an 
synthesis  of 
intermediate 
(MDA), 
methylene 
(MDI), 
diphenylmethanediisocyanate 
hexamethylenetetramine; 
in 
HTMA which is used as a curing agent, 
the 
rubber 
manufacture 
explosives, 
trimethylolpropane, 
neopentylglycol, 
pentaerythritol,  butanediol  (BDO)  and 
acetylenic agents 
Used  in  adhesives  and  used  in  biocidal 
applications  

accelerator 
of 

the 
dianiline 

used 

and 

in 

in 

of 
and 

paints, 
Manufacture 
similar 
varnishes 
coatings,  printing  inks  and 
mastics 
Code 
(NACE 
C20.3) 

Urea-formaldehyde (UF) resin 
Melamine  formaldehyde  (MF) 
resin 
Phenolformaldehyde (PF) resin 

Used  as  a  binding  agent  in:  paints, 
polishes,  varnishes,  lacquers,  wax  for 
furniture  and  floors,  furniture  polish, 
shoe  shine,  printing 
inks,  external 
coating for cars and in external coatings 

143 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sector 

Form 

Applications 
for  building  claddings  and  for  white 
goods etc. 

cleaning 

Manufacture  of  soaps  and 
and 
detergents, 
preparations, 
polishing 
perfumes 
toilet 
preparations  (NACE  Code 
C20.4) 

and 

Preservatives 
Nail hardening agents 
Disinfectants 

Used  in  the  preservation  of  cosmetic 
products  and  raw  materials  against 
microbial  contamination;  use  in  certain 
cosmetic  treatments,  such  as  hardening 
of fingernails; and plant and equipment 
shower  gels, 
hygiene. 
shampoos,  deodorants,  nail  hardeners, 
etc. 

  Used 

in 

Manufacture  of  explosives 
(NACE Code C20.51) 

Urea-formaldehyde (UF) resin 
Melamine formaldehyde (MF) 
resin 

Used  in  the  form  of  foam  resin  and 
other  in:  Household  cleaning  products, 
carpet  cleaning  agents,  car  cleaning 
agents, 
cleaning 
products,  etc.  Used  as  an  antimicrobial 
preservative in household and industrial 
products; and used to clean surfaces and 
equipment 

swimming 

pool 

of 

Manufacture 
basic 
pharmaceutical products and 
pharmaceutical  preparations 
(NACE Code C21) 
Manufacture  of  rubber  and 
plastic 
(NACE 
products 
Code C22) 
Manufacture  of  fabricated 
metals,  except  machinery 
and equipment (NACE Code 
C25) 

Manufacture  of  electrical 
equipment 
(NACE  Code 
C27) 
Manufacture  of  machinery 
and equipment n.e.c. (NACE 
Code C28) 
Manufacture 
of  motor 
vehicles,  trailers  and  semi-
trailers (NACE Code C29) 

Polyacetal (POM) resin 

Preservatives 
Formaldehyde resins 

Polyacetal (POM) resin 

inactivating  agent 

Used  in  the  manufacture  of  explosives 
such as RDX 
Used  as  an 
in 
vaccines:  e.g.  human  vaccines  and 
medicines; and used in the manufacture 
of gelatin capsules 
Used in tyre and rubber manufacturing 

Uses  as  metal  remover  fluids,  as  anti-
corrosive  agent,  as  an  oxidising  and 
reducing  agent,  used 
in  electroless 
plating,  used  in  coatings  and  used  to 
harden sand in foundries. 
Metalworking 
fluids  can  also  be 
formaldehyde  releasing  agents,  such  as 
triazine;  used  in  paints  and  coatings  to 
extend shelf life 
Electrical/electronic appliances parts 

Phenol formaldehyde resin 

Production of abrasive wheels 

Polyacetal (POM) resin 

Phenolformaldehyde (PF) resin 

Used  for  safety  belt  components,  fuel 
system 
engine 
components 

components 

and 

Manufacture  of 
(NACE Code C31) 

furniture 

Urea-formaldehyde (UF) resin 

Phenolformaldehyde (PF) resin 

Used  as  a  “glue  resin”  in  the  furniture 
manufacturing industry 

Water  collection,  treatment 
and  supply  (NACE  Code 
E36) 

Used in water control (laboratories) and 
water purification 

144 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Form 

Applications 
Precious metals recycling 

UF foam; PF foam 

agents 

Stabilising 
photographic colour processing 
Hardener/crosslinking agents 
Binding agent 

in 

and 

in  building 

Used 
insulating 
materials;  and  used  as  an  adhesive  in 
mineral  wools  that  are  used  as  thermal 
insulators 
Photographic  materials 
papers) and processes 

(plates  and 

Used  as  a  laboratory  reagent;  used  in 
electrophoresis of RNA; and used in the 
synthesis  of  chelating  agents  and 
pyridines 

Antiseptic,  antimicrobial  food 
additive, disinfectant 

Used in animal feed, fish vaccines, etc. 

Schools  and  universities:  Used  as  a 
preservative  for  specimen  and  tissue 
samples;  used  for  fixation;  and  used  in 
teaching courses 

disposal 

Sector 
Waste  collection,  treatment 
activities; 
and 
materials  recovery  (NACE 
Code E38) 
Construction  of  buildings 
(NACE Code F41) 

research 

Professional,  Scientific  and 
Activities: 
Technical 
Photographic 
activities 
(NACE Code M74.2)   
Professional,  Scientific  and 
Technical 
Activities: 
and 
Scientific 
development  (NACE  Code 
M72) 
Professional,  Scientific  and 
Activities: 
Technical 
Veterinary activities (NACE 
Code M75)   
Education 
P85.4): 

(NACE  Code 

Human  health  and  social 
activities:  Human 
work 
health 
(NACE 
activities 
Code Q86) 

Health  services:  Used  for  cleaning 
equipment, 
and 
surfaces 
medical 
environments; 
to  maintain 
used 
specimens  and  tissue  samples;  and  is 
also  used  as  a 
tissue  preservative 
(typically 10% concentration 
Dentistry:  Used  for  antiseptic  and 
disinfectants  e.g.  composite 
resins 
replacing  amalgam  and  root  canal 
fillings 
Used as an embalming agent 

Formalin 

Funeral and related activities 
(NACE Code S96.0.3) 
Sources:  
ANSES  (2016):  Analysis  of  the  most  appropriate  risk  management  option  (RMOA)  -  formaldehyde.  
http://www.consultations-publiques.developpement-
Available 
durable.gouv.fr/IMG/pdf/RMOA_Formaldehyde_040716.pdf 
Consultation Responses 
Formacare (2014):  About formaldehyde.  Available at: http://www.formacare.org/about-formaldehyde/ 
IPCS 
http://www.inchem.org/documents/hsg/hsg/hsg057.htm#SectionNumber:1.5 
RPA (2006):  Comparative Assessment of Alternatives in Formaldehyde in Consumer and Non-Consumer 
Products and Applications.  Report for AFSSET 

Formaldehyde 

Available 

(1991): 

Guide. 

Health 

Safety 

and 

at: 

at 

Estimated EU workers exposed 

145 

 
 
 
 
 
 
 
 
 
 
 
 
 
This  section  first  summarises  the  estimates  at  the  EU-28  level  of  exposed  workers  and 
then provides a breakdown by sector. It is of note that there are differences in estimates 
between different sources. 

The starting point for estimating the occupationally exposed population to formaldehyde 
is  the  CAREX  database127,128,  with  further  estimates  being  available  from  SUMER 
(France  in  2003129  and  2010130),  FinJem  (Finland,  reproduced  in  Santonen,  2013131), 
Regex (Czech Republic)132, and Siew et al133.  These estimates are summarised below. 

Table 62: Published data – workforce exposed to formaldehyde 

Study 

CAREX 

Country 

Year/period 

EU15 

France 

Finland 

Czech 
Republic 
UK 

1990-1993 
(mean) 
1990-1993 
(mean) 
1990-1993 
(mean) 
1997 

1990-1993 
(mean) 
2003 

2010 

SUMER 

France 

FinJem 

Finland 

2006 

No. of exposed 
workers 
971,402 

% of exposed 
workforce 

Notes 

307,025 

10,530 

43,669 

93,807 

153,600 
(66,800 men 
and 86,800 
women) 
139,400 
(66,100 men 
and 73,300 
women) 
10,700 

0.9% (0.7% 
men and 1.2% 
women) 

0.6% (0.6% 
men and 0.7% 
women) 

Woodworking 
& furniture 
industry, 
foundries 

Siew et al 

Global 

Not specified 

1% 

127  See: http://oem.bmj.com/content/57/1/10;  
128  Kauppinen et al. (2000): Occupational exposure to carcinogens in the European Union.  Occ Environ 

Med 57, p. 10–18. 

129  http://dares.travail-emploi.gouv.fr/dares-etudes-et-statistiques/enquetes-de-a-a-z/article/surveillance-

medicale-des-expositions-aux-risques-professionnels-sumer-edition-115982 

130  http://dares.travail-emploi.gouv.fr/dares-etudes-et-statistiques/enquetes-de-a-a-z/article/surveillance-

medicale-des-expositions-aux-risques-professionnels-sumer-edition 

131  Santonen 

through 
http://ec.europa.eu/social/BlobServlet?docId=11305&langId=en 

Well-being 

(2013): 

work, 

available 

at 

132  Regex (2016): Registry of Subjects Occupationally Exposed to Carcinogens,  National Health Institute 
at 

(2016), 
http://www.szu.cz/uploads/documents/chzp/odborne_zpravy/OZ_16/Prace_2016.pdf 

available 

133  Siew  et  al  (2012):  Occupational  exposure  to  wood  dust  and  formaldehyde  and  risk  of  nasal, 
nasopharyngeal, and lung cancer among Finnish men, In: Cancer Management and Research August 
at: 
2012, 
https://www.researchgate.net/profile/Pentti_Kyyroenen/publication/230699498_Occupational_exposur
e_to_wood_dust_and_formaldehyde_and_risk_of_nasal_nasopharyngeal_and_lung_cancer_among_Fi
nnish_men/links/00b7d5229fa1e27a67000000.pdf 

available 

146 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                            
 
Study 

Regex 

Country 

Year/period 

Czech 
Republic 

2009-2016 

No. of exposed 
workers 
173 

% of exposed 
workforce 

Notes 

In addition, the total number of potentially exposed workers, as well as figures by sector, 
were  estimated  based  on  data  obtained  through  consultation  and  for  some  sectors  by 
estimating the share of exposed workers based on the extent of formaldehyde application 
within the relevant sectors.  

In order to be able to compare the results from different sources, the published data have 
been extrapolated to EU28 and the year 2015 based on the number of persons employed 
in each country and based on the changing trends in employment during the time period 
concerned.  According  to  Eurostat,  the  total  number  of  people  in  employment  or  self-
employment  in  the  EU-28  was  220  million  in  2015.  Applying  the  estimates  of  the 
proportion  of  the  exposed  workforce  in  the  table  above  suggests  an  occupationally 
exposed population between 1.3 million and 2.2 million. A comparison of the number of 
workers exposed to formaldehyde identified through different sources is presented below.  

Table 63: Comparison of the number of workers exposed to formaldehyde identified 

through different sources 

of  workforce 

using 

Source of data 

Consultation/share 
Eurostat data 

Carex database* 

FinJem database* 

Sumer 

Siew et al 

Number of exposed workers in the EU28 in 

2015 

0.99 million 

1.4 million 

0.99 million 

1.6 million 

2.2 million 

*data have been extrapolated based on employment shares from Eurostat (2015): Structural Business 

Statistics. Available at: http://ec.europa.eu/eurostat/web/structural-business-statistics/data/database. 

Source: RPA (2018) 

The lowest estimate is 990 000 which was obtained through consultation and estimation 
of  workers  using  Eurostat  data.  It  corresponds  with  another  estimate  which  relies  on 
extrapolation to the EU-28 of the FinJem data (the Regex data for the Czech Republic are 
considered to be an outlier). The highest estimate can be derived on the basis of applying 
the 1% estimate in Siew et al134to the total EU workforce which yields an estimate of 2.2 
million.  All  other  estimates  and  extrapolations  (CAREX,  SUMER)  fall  between  these 
two values.  

134  Siew et al (2012): Occupational exposure to wood dust and formaldehyde and risk of nasal, 

nasopharyngeal, and lung cancer among Finnish men, In: Cancer Management and Research August 
2012, available at: 
https://www.researchgate.net/profile/Pentti_Kyyroenen/publication/230699498_Occupational_exposur
e_to_wood_dust_and_formaldehyde_and_risk_of_nasal_nasopharyngeal_and_lung_cancer_among_Fi
nnish_men/links/00b7d5229fa1e27a67000000.pdf 

147 

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

Relevant sectors, uses and activities 

The relevant sectors and uses where occupational exposure is expected to take place are 
summarised below. 

Table 64: Relevant sectors and uses – MOCA 

Sector 

Group  

Plastics industry, 
chemicals sector 

Suppliers of the 
polyurethane sector  

Use/activity 

Providing MOCA and 
MOCA containing 
polyurethane systems 

Plastics industry 

Polyurethane moulders   Catalyst and chain 

extender by 
manufacture of 
polyurethane 
Analysis of MOCA in 
biological samples and 
workplace air 

Laboratories 

Research and 
commercial 
laboratories 
Source: based on REACH Law (2016a) 

The most relevant sectors/uses  

of 

Number 
companies 
5 

89 (best estimate but 
it is noted that the 
maximum is less than 
120) 
Not investigated 

According  to  the  application  for  authorisation,  the  supply  chain  for  MOCA  is  as 
illustrated below: 

Figure 12: Supply chain for MOCA (reproduced from Reach Law, 2016b) 

The scope of possible occupational exposure is limited to the importers of MOCA into 
the EEA (distributors and system providers) and their direct customers designated Level 
1  (system  providers)  and  Level  2  (moulders)  in  the  figure.  The  following  is  extracted 
from the documents for the application for authorisation (REACH Law, 2016b).  

148 

 
 
 
 
 
Level  1:  System  providers  sell  cast  polyurethane  systems  (e.g.  prepolymers,  curatives, 
additives,  and also  machinery) to  moulders. There are 5 companies on this level of the 
supply chain and these are spread across Europe. The companies generally supply both 
machines  and  reagents  to  their  customers  and  the  systems  they  have  available  to 
moulders cover a wide spectrum of castable polyurethane formulations combining most 
diisocyanates and polyols available.  

Level  2:  Moulders  produce  polyurethane  articles.  The  application  for  authorisation 
contains  information  on  moulders  based  on  questionnaire  responses  representing  about 
66%  of  the  EU  tonnage  within  this  supply  chain.  The  document  distinguishes  between 
three  categories  of  moulders  and  their  relative  percentage  in  the  supply  chain  is  given 
below:  

  Generalised  moulders (60 %) who produce make-to-order products, low quantity per 
products,  serving  a  large  number  of  industries.  MOCA  range  from  a  few  percent  to 
100% of production. Typically quantities: 0.1-12 t/year.  

  Specialised  moulders  (15  %)  who  produce  a  large  quantity  of  specific  products, 
serving specific industries. MOCA used in 80-100% of production. Typical quantities: 
7-80 t/year. 

  Mixed  moulders  (25%)  who  have  mixed  characteristics.  MOCA  used  in  30-95%  of 

production. Typical quantities: 6-40 t/year. 

It is in the application estimated that about 89 companies operate at this level across the 
entire EU. The information on the amount of moulders in the supply chain comes directly 
from  the  system  providers  that  supply  MOCA  to  them  and  it  is  concluded  in  the 
application that there is a defined number of moulding companies that does not exceed 
120 businesses. The average consumption of MOCA in the companies can be estimated 
at approximately 5.6 t/year if the number of 89 is used. 

All  moulders  are  in  the  application  for  authorisation  surveyed  as  micro-  (<  10  worker; 
20%), small- (10-50 worker; 65%) or medium- (50-250 worker; 15%) sized enterprises 
as defined by the European Commission.  

As  part  of  the  preparation  of  the  application,  a  questionnaire  was  undertaken  by  the 
applicant  in  order  to  gather  information  about  use  conditions,  company  size  and 
exposure.  The  application  estimates  in  the  socioeconomic  analysis  (of  the  application) 
that  moulders  have  a  median  number  of  23  workers  with  1  worker  as  minimum.  The 
mean number is not provided. The companies answering the questionnaire survey in total 
had 892 workers and represented 65% of the total volume of MOCA. If this number is 
extrapolated on a number of worker’s per tonne basis, the total number of workers would 
be 1,526, which is considered the best estimate.  

Chemtura,  which  until  recently  has  been  supplier  of  MOCA  for  the  EU  market, 
performed another market survey in 2015. They identified a total of around 50 MOCA 
users  who  collectively  used  some  350  tonnes  of  MOCA  per  year  (Corden  and  Tyrer, 
2017) i.e. on average the consumption of MOCA in these companies was 7 t/year. The 
same  data  showed  that  the  maximum  MOCA  usage  in  one  company  within  these  50 
companies  was  around  50  tonnes  per  year  and  the  smallest  amount  used  was  1  tonne. 
This  survey  indicated  that  the  largest  producers  employ  some  60  workers;  the  smallest 
around 5 and the average company employed 12 people (Corden and Tyrer, 2017). Even 
the average is somewhat lower in this survey as compared to the number indicated in the 

149 

 
 
application for authorisation, the data are quite well in accordance with those provided in 
the  application  and  support  that  the  majority  of  the  users  are  micro  and  small-  sized 
companies. 

According to the Annex XV report (ECHA, 2011a), based on the information from the 
industry,  the  supply  chain  around  year  2010  consisted  of  importers,  distributors  and 
industrial  users  with  a  total  of  more  than  200  use  sites  within  the  EU.  MOCA  was 
supplied as substance of its own or in mixtures containing the substance. A decrease from 
200 sites to less than 100 in 2017 is well in accordance with general information from the 
sector indicating a decline in the use of MOCA.  

According  to  Cocker  et  al.  (2009),  in  late  2005/2006  around  25  companies  in  the  UK 
were  using  MOCA  in  the  manufacture  of  polyurethane  elastomers.  Twenty  of  the  25 
companies  visited  in  a  survey  ranged  from  micro  companies  (<10  workers)  to  small–
medium  enterprises  (10–250  workers).  The  average  number  of  workers  per  site  is  not 
reported  but  it  is  indicated  that  ~300  workers  are  directly  exposed  to  MOCA  during 
polyurethane elastomer production and ~1000 workers are indirectly exposed i.e. around 
12  workers  per  company  are  directly  exposed  and  40  indirectly  exposed.  This  could 
indicate that the average size of UK companies using MOCA at that time were somewhat 
larger than the average within the supply chain of the applicant. This will be discussed 
further in the use of the data from the UK surveys to extrapolate to the EU level.  

Manual vs. automatic processing 

As  indicated  in  the  application  for  authorisation,  the  users  of  MOCA  "either  perform 
their  tasks  in  manual  processes  or  using  machines.  The  exposure  potential  of  the  hot 
casting processes can, consequently, be divided into automated and manual processes. In 
the automated process the substance handling, melting and mixing are performed inside 
an  enclosed  machine,  whereas  in  manual  process  these  steps  are  performed  manually. 
The highest potential for exposure during the casting processes is the manual handling, 
mixing steps and maintenance tasks." 

According  to  the  survey  undertaken  by  the  applicant  most  of  the  moulding  shops  use 
automated moulding machines, but some still use manual moulding e.g. when producing 
smaller articles. As discussed later, the application provides risk estimates for the manual 
and automatic processes separately.  

As  the  data  from  the  UK  surveys  of  worker  exposure  will  be  extensively  used  on  the 
description  of  exposure  levels,  it  is  relevant  to  discuss  to  what  extent  the  UK  survey 
results  also  represent  manual  processes.  According  to  Cocker  et  al.  (2009),  manual 
methods were used in 15 of the 20 visited sites. It is reported that the handling of MOCA 
during polyurethane elastomer production was essentially the same in all ﬁrms using the 
manual  method.  "MOCA  pellets  or  granules  were  scooped  from  a  keg  and  placed  in  a 
container  (pan  or  beaker).  Then,  under  an  LEV  system,  the  container was  heated  on  a 
hot plate to 98–110 ˚C and stored until mixed with a liquid pre-polymer resin, at 60–80 
˚C, containing TDI or HDI. Colourants may be added at this stage and then mixed. The 
ratio of MbOCA to resin is generally 1:10 but may be up to 3:10" (Cocker et al., 2009). 
Five companies used automated methods to process MOCA but according to the authors 
there  was  still  potential  for  spillage  and  exposure  during  the  ﬁlling,  dispensing,  and 
mixing  stages.  "The  mixed  polyurethane  was  de-gassed  and  poured  into  moulds 
preheated to 90–95 ˚C. Following casting, the moulds were cured in ovens at 100–120 

150 

 
 
˚C for 4–24 h. After curing, the products were released from the moulds and excess ash 
and spurs were removed by trimming with a knife or scissors." 

  Downstream uses  
The  polyurethane  parts  are  used  by  a  wide  array  of  industries  for  many  different 
applications.  Occupational  exposure  to  MOCA  in  the  workplace  air,  by  downstream 
users of the cured polyurethane parts, is considered low or insignificant and not further 
assessed.  

  Laboratories 
Small amounts of analytical standards for MOCA are used in laboratories for analysis of 
MOCA  in  biological  samples  and  in  workplace  air.  The  occupational  exposure  by  the 
analysis  is  considered  insignificant.  MOCA  is  not  used  as  analytical  reagent  for  any 
known laboratory analysis.  

Applications 

MOCA  is  used  as  a  curing  agent/chain  extender  in  cast  polyurethane  elastomer 
production.  Castable  polyurethanes  form  a  part  of  the  overall  polyurethane  industry. 
They  are  prepared  by  mixing  3  main  constituents:  the  polyol,  the  diisocyanate  (which 
together form the prepolymer) and a curing agent/chain extender such as MOCA. Before 
mixing  with  the  prepolymer,  MOCA  is  first  melted  at  ca.  120°C.  The  resulting  molten 
polyurethane  is  then  moved  to  a  moulding  area  and  poured  into  the  moulds.  The 
moulding process can be performed either manually or in an automated system. Finally, 
when the moulds are cast they are cured at 70-80 °C.  

MOCA is used in the production of polyurethane elastomers to give specific properties 
(such  as  heat,  fuel,  and  solvent  resistance,  high  abrasion  properties,  and  high  load-
bearing and favourable mechanical and dynamic properties) to the polyurethane products. 

According  to  Corden  and  Tyrer  (2017)  in  a  report  prepared  for  Chemtura  (a  previous 
provider of MOCA and now provider of alternatives), typical products in which MOCA-
based cast polyurethanes are used are: 

 Rolls;  
 Wheels;  

 
 
  Hydrocyclones;  
 
 
 
 
 
 
 
 
 
 
 
 

 Dynamic bend stiffeners;  
 Power transmission belts;  
 Vibratory bowls for metal finishing;  
 Gaskets;  
 Pump impellers;  
 Pipeline pigs;  
 Belt scrapers;  
 Snow plough blades;  
 Internal pipe liners;  
 Die pads;  
 Railway components; and  
 Bushings.  

151 

 
 
 
According  to  the  application  for  authorisation  "Products  made  with  a  MOCA  cured 
system  include  wheels  and  rollers  covered  by  polyurethane;  technical  machine  parts; 
timing  and  other  types  of  belts  used  in  many  applications  e.g.  printers,  money  sorting 
machines security cameras, sprinkler systems etc.; textile and paper manufacturing; and 
general  machinery  uses.  MOCA  cured  systems  are  used  for  roller  coating  for  any 
industrial  sector,  cone  separators  for  paper  industry,  roller  covers  for  steel  industry, 
street furniture, sheets and scrapers. Polyurethane covered rollers are used especially in 
the steel, aluminium, paper, carton, wood and textile industry." 

Estimated EU workers exposed 

After  the  REACH  Annex  XIV  sunset  date  of  22  November  2017,  MOCA  can  only  be 
used by the downstream users in the supply chain of the only applicant for authorisation. 
The authorisation has not yet been granted. 

The application  for authorisation estimates  the total  number of exposed workers by the 
moulders at 89 sites across the EU to be 213. This figure was derived from the number of 
potentially  exposed  workers  reported  in  survey  responses,  giving  a  potential  exposure 
worker per tonne ratio of 0.41. The total was then calculated by extrapolating to the total 
MOCA use of 516 t/year.  

This  figure  would  correspond  to  less  than  3  workers  per  site.  The  total  number  of 
workers by the users of MOCA in the supply chain of the applicant can be estimated at 
1,526.  Consequently,  the  percentage  of  the  total  workforce  in  the  companies  which  is 
exposed  to  MOCA  would  be  14%.  This  seems  to  be  relatively  low  as  compared  with 
information from a UK survey. 

The Health and Safety Executive (HSE) in the UK estimated that in the years 2005/2006, 
300 workers in the UK were directly exposed to MOCA during polyurethane-elastomer 
production,  and  more  than  1,000  workers,  such  as  office  staff,  were  indirectly  exposed 
(Cocker  et  al.)135.  The  directly  exposed  workers  represent  23%  of  all  exposed  workers, 
which  is  assumed  to  be  identical  to  the  total  number  of  workers  of  the  companies. 
Indirect  exposure  would  be  by  the  dermal  route  by  touching  surfaces  with  MOCA 
contaminated by workers directly exposed by production work processes. The total use of 
MOCA in the UK is reported at >200 tonnes in 2006 which is an increase from a level of 
90-120 tonnes in 1995. The consumption of MOCA per worker was significantly lower 
in the UK in 2005/2006 as compared to the data from the supply chain of the application 
which  presumably  reflects  an  increase  in  the  efficiency  in  the  companies  with  larger 
production output per worker due to increased automation.  

As the data from the UK is based on a systematic survey of 20 out of 25 companies in the 
industry with extensive measurements of workplace exposure concentration and urinary 
MOCA  concentration,  the  results  are  considered  to  better  reflect  the  actual  exposure 
situation  in  the  industry  than  the  results  of  the  survey  of  the  applicant  of  the  REACH 
authorisation.  Consequently,  it  is  assumed  that  23%  of  the  total  number  of  1,526 
workers,  corresponding  to  350  workers  would  be  the  exposed.  The  remaining 
approximately 1,200 workers may potentially be indirectly exposed. The estimated 350 
workers  is  only  slightly  higher  than  the  300  workers  in  the  UK  alone  in  2005/2006, 

135  Cocker,J., Cain, J.R., Baldwin, P., McNally, K., Jones, K. (2009): A Survey of Occupational Exposure 

to 4,4'-methylene-bis (2-chloroaniline) (MbOCA) in the UK. Ann. Occup. Hyg., 53: 499–507. 

152 

 
 
 
                                                            
where the total consumption was reported at >200 t/year. This indicates that the number 
of workers per tonne used was higher in the UK in 2005/2006 than in the supply chain of 
the  applicant  today,  but  this  is  considered  to  be in  accordance  with  the higher  share  of 
automatic processes in the supply chain of the applicant.  

Regional  distribution.  According  to  the  survey  undertaken  for  the  application  for 
authorisation, moulders within the supply chain of the applicant are located in Belgium, 
Denmark, France, Italy, Ireland, Greece, Hungary, Portugal, Spain, the Netherlands, and 
the  United  Kingdom.  In  addition,  some  moulders  not  responding  to  the  survey  may  be 
located in other MS. The distribution of the consumption by MS is not provided. 

Suppliers. Suppliers do not handle MOCA directly but supply ﬁlled drums as delivered 
by the manufacturer. Cooker et al. (2009) took samples from two UK importers/suppliers 
of MOCA in 2005/2006. At the two suppliers, samples (n =28) were collected from the 
outside  surfaces  of  recently  imported  kegs,  pallets,  and  the  ﬂoor  around  kegs.  Six 
samples had detectable levels  and four  of these were  from the ﬂoor and pallets in  both 
suppliers.  Samples  were  also  taken  of  staff  of  suppliers  but  the  results  are  not  reported 
separately. The application for authorisation does not address exposure by the suppliers. 
According  to  information  obtained  from  ReachLaw136  for  this  study,  the  MOCA  is 
packed  in  drums  in  China.  The  MOCA  drums  are  inspected  with  Swype  tests  in  the 
factory in China before shipping to ensure that there is no contamination on the surface 
of  the  drums.  Any  exposure  by  the  suppliers  would  be  by  the  dermal  route  to 
contaminants on the surface of the packaging and not further assessed. 

Historical exposure 

CAREX (1999) estimated the numbers of workers potentially occupationally exposed to 
MOCA in the EU at 3,300 distributed within the following sectors:  

  Manufacture of plastic products not elsewhere classified: 1,390 

  Manufacture of rubber products: 1,360 

  Manufacture of industrial chemicals: 100 

  Manufacture of miscellaneous products from petroleum and coal: 10 

  Research and scientific institutes: 430 

Polyurethane elastomer are by some considered "rubber" whereas by others as "plastic", 
and  the  figures  for  manufacture  of  the  two  materials  probably  both  represent  the 
manufacture  of  polyurethane  elastomers,  so  the  total  for  this  sector  is  2,750  exposed 
workers. MOCA was at that time manufactured within the EU, but has for more than 10 
years only been imported.  

The  CAREX  data  was  used  by  IOM137  in  a  previous  study  where  it  was  estimated  that 
2,500 workers were exposed to MOCA in the EU, of which about 1,400 were estimated 
to potentially be exposed in high-exposure industries (manufacture of rubber and plastics 
products).  

136  REACHLaw (2017): personal communication with RuaidríMacDomhnaill, REACHLaw Oy. 
137  Health, socio-economic impact and environmental aspects of possible amendments to the EU Directive 
on  the  protection  of  workers  from  the  risk  related  to  carcinogens  and  mutagens  at  work.  4,4’-
methylene-bis-ortho-chloroaniline (MbOCA). IOM and partners. 

153 

 
 
                                                            
Trend in number of exposed workers 

No data exist on the trend in number of exposed workers. An indication of the trend in 
number  of  exposed  workforce  could  be  derived  from  the  trend  in  the  consumption  of 
MOCA in the EU, but detailed data on this trend is not available. Furthermore, it could 
be expected that more workers were exposed in the past because manual processes were 
more widespread.  

The  available  data  on  number  of  exposed  worker  is  summarised  in  the  table  below.  A 
distribution by Member State is not available. 

Table 65: Number of workers exposed to MOCA 

Country/Region 

EU 28 

Number of sites 
89 (best estimate ) 

No. of exposed workers 
350 directly exposed 

Indirectly  exposed  workers 
by the dermal route ~ 1,200 

Sector  
Plastics sector 
Moulding of 
polyurethane 
elastomer parts 
Source: RPA (2018) 

Exposure concentrations 

The  only  comprehensive  dataset available  on  exposure  concentrations  in  the  workplace 
air is the data obtained in the UK in 2005/2006.  

The  highest  levels  were  found  for  workers  undertaking  manual  processes  which  are 
supported by modelling results from the  application for authorisation. The dataset is 12 
years  old  and  most  of  the  companies  used  at  that  time  manual  processes.  According  to 
the application today most companies use the automatic process. On the other hand most 
MS have higher OELs than applied in the UK and the companies would be less forced to 
reduce  the  exposure  levels.  New  data  from  Australia  shows  significantly  lower  levels 
than reported in the UK 2005/2006 survey.  

Table 66: Distribution of workers by exposure concentration 

1 

< 
µg/m3 
183 

1-1.5 
µg/m3 
12 

1.5-5 
µg/m3 
11 

0 

5-10 µg/m3 

10-15 µg/m3 

Number of 

workers - UK 
survey 
Percentage 
Number of 

workers at EU 
level 

Source: RPA (2018) 

88% 

6% 

5% 

0% 

308 

20 

19 

0 

2 

1% 

3 

Urinary concentrations 

For  the  subsequent  estimation  of  the  current,  past  and  future  current  burden  of  disease 
based  on  urinary  concentration  an  arithmetic  mean  value  of  urinary  levels  in  mol/mol 
creatinine  is  used.  As  the  exposure  risk  relationship  (ERR)  is  linear  without  threshold, 
only the mean value is needed for calculation of the burden. 

154 

 
 
 
 
 
 
As  for  the  exposure  concentrations,  the  best  dataset  is  available  from  the  UK,  and  as 
mentioned above, these data are considered to be representative for the companies in the 
supply chain of the applicant for authorisation.  

For the 2005/2006 survey, a mean value for the 40 out of 78 samples above the detection 
limit is reported to be 3.2 µmol/mol creatinine. If the analyses below the detection limit 
is set at half the detection limit (0.4/2 µmol/mol creatinine) a geometric mean value for 
entire dataset can be estimated at 1.8 µmol/mol creatinine. IOM138 estimated, on the basis 
of the same dataset using Monte Carlo modelling for the data below the detection limit, a 
mean value for the dataset at 2.3 µmol/mol creatinine. The median is reported to be 3.2 
µmol/mol creatinine.  

For the surveys from 2008 and 2011 no mean value were reported but the median values 
were in both surveys reported at 1.6 µmol/mol creatinine i.e. about half the value in the 
2005/2006  survey  and  the  mean  value  is  likely  also  significantly  lower.  The  median 
values reported for the application for authorisation for the 9 companies reporting on the 
median, it range from 0 to 10.3 µmol/mol creatinine with an average value of 3.2 (not a 
mathematically  correctly  derived  median  but  a  simple  average  of  reported  median 
µmol/mol creatinine).  

Based on the available data a mean value of 2 µmol/mol creatinine (range 1 - 3 µmol/mol 
creatinine)  is  set  as  the  most  likely  value  and  used  for  the  calculation  of  the  current 
burden of disease. 

138  Health, socio-economic impact and environmental aspects of possible amendments to the EU Directive 
on  the  protection  of  workers  from  the  risk  related  to  carcinogens  and  mutagens  at  work.  4,4’-
methylene-bis-ortho-chloroaniline (MbOCA). IOM and partners. 

155 

 
 
 
 
                                                            
Annex 8: route(s) of exposure, adverse health effects 

Cadmium and its inorganic compounds  

Occupations in which the highest potential exposures occur include cadmium production 
and  refining,  nickel-cadmium  (Ni-Cd)  battery  manufacture,  cadmium  pigment 
manufacture  and  formulation,  cadmium  alloy  production,  mechanical  plating,  zinc 
smelting,  brazing  with  a  silver-cadmium-silver  alloy  solder,  and  polyvinylchloride 
compounding.139  Recycling  of  scrap  metal  and  Ni-Cd  batteries  may  also  involve  some 
exposure. 140 

Route of exposure 

The major route of occupational exposure is inhalation of cadmium-containing dust and 
fumes.  Additional  uptake  can  occur  through  incidental  ingestion  of  dust  from 
contaminated hands, cigarettes or food.  

Adverse health effects 

Cadmium  is  an  established  human  carcinogen.  Most  evidence  is  available  for  elevated 
risk  for  lung  cancer  after  occupational  exposure;  however,  associations  between 
cadmium exposure and tumours at other locations including kidney, breast, and prostate 
may be relevant as well. 

Different  and  a  priori  non-mutually  exclusive  mechanisms  for  the  carcinogenicity  of 
cadmium  have  been  identified.  All  these  mechanisms  are  non-stochastic  and  are 
characterised by a threshold below which no effect is expected. Cadmium can therefore 
be considered as a genotoxic carcinogen for which a practical threshold can be identified. 

Major  target  organs  for  non-cancer  effects  of  cadmium  and  inorganic  cadmium 
compounds are  

  The kidneys;  
  The bones; 
  The respiratory tract (from inhalation exposure). 

Cadmium  and  inorganic  cadmium  compounds  are  also  classified  as  reproductive 
toxicants. 

Kidney toxicity is often regarded as critical toxicity.  Tubular proteinuria is the first sign 
of  renal  toxicity  (ECHA,  2013d;  EFSA,  2011;  SCOEL,  2017).  However,  some  authors 
question  that  minor  proteinuria  is  already  indicative  of  an  adverse  effect  induced  by 
cadmium (e.g., Byber et al., 2016; Byber et al., 2017).  

Osteoporosis can also be enhanced by cadmium.  Some studies indicate effects associated 
with  similar  cadmium  exposures  as  for  first  kidney  effects  (Åkesson  et  al.,  2014; 

139  IARC (2016) Monograph: Cadmium and Cadmium Compounds. 

Available at: https://monographs.iarc.fr/ENG/Monographs/vol100C/mono100C-8.pdf 

140  SCOEL  (2017):  Opinion  from  the  Scientific  Committee  on  Occupational  Exposure  Limits  for 
at: 
compounds. 

SCOEL/OPIN/336. 

Available 

Cadmium 
https://circabc.europa.eu/sd/a/13cad802-1f3c-40c0-bce4-6838cf5fc4ff/OPIN-
336%20Cadmium%20and%20its%20inorganic%20compounds.pdf 

inorganic 

and 

its 

156 

 
 
                                                            
Buhaund  Matovic,  2016;  Suwazono  et  al.,  2010;  Wallin  et  al.,  2016)  and  may  not  be 
secondary to kidney impairment (Engström et al., 2009).  

Respiratory  effects  (including  but  not  limited  to  carcinogenicity)  are  a  very  important 
endpoint  from  inhalation  of  cadmium  particles,  often  regarded  as  the  critical  effects  or 
occurring an only slightly higher exposures compared to systemic effects.   

Even  though,  cadmium  and  inorganic  cadmium  compounds  are  classified  reproductive 
toxicants,  this  endpoint  is  currently  not  in  focus,  when  OELs  are  derived.  Apparently, 
effect concentrations are above those relevant for the other mentioned effects. 

There are contradictory data on dermal sensitisation and no data on sensitisation  of the 
respiratory tract from cadmium exposure.  

Beryllium and inorganic beryllium compounds 

Occupational  exposure  to  beryllium  occurs  in  various  industries,  the  majority  during 
production of beryllium metal and beryllium containing alloys. Processes most likely to 
generate  airborne  beryllium  are  related  to  melting,  casting, hot  working,  or  abrasion  of 
beryllium containing alloy, accordingly the workers with the highest exposure potential 
are  employed  in  processes  of  mining,  production  of  beryllium  alloys,  phosphorus 
manufactures, ceramic production, nuclear reactors, production of electric and electronic 
equipment, missile technicians and jewellers.141 

Route of exposure 

Exposure to beryllium and its compounds at the workplace occurs mainly via inhalation, 
with only minor skin absorption for the less soluble beryllium compounds.  

Adverse health effects 

Beryllium  is  a  classified  local  carcinogen  in  the  respiratory  tract  (Cat.  1B  carcinogen, 
H350i), however, probably with a low potency. The mode of action for the carcinogenic 
effects is not fully understood, but, in most recent assessments, the substance is regarded 
to  act  via  indirect  genotoxicity  and  epigenetic  mechanisms  and  therefore  considered  a 
threshold carcinogen.   

The main non-carcinogenic health effects are:  

  Chronic beryllium disease (CBD) 
  Beryllium respiratory sensitisation (BeS) 

CBD is a cell-mediated immunological reaction of delayed type, usually observed after a 
long latent period. BeS precedes CBD, but the progression from sensitisation to disease 
is not fully understood. 

Dermal  exposure  to  beryllium  and  beryllium  compounds  can  cause  allergic  contact 
dermatitis  or  a  granulomatous  skin  reaction.  In  addition,  with  regard  to  non-cancer 
effects,  skin  sensitisation  has  to  be  considered.  Systemic  effects  (cardiovascular,  renal, 
hepatic  and  haematological  effects)  are  assumed  to  be  induced  secondary  to  functional 

141  SCOEL (2017): Recommendation from the Scientific Committee on Occupational Exposure Limits for 
at: 

SCOEL/REC/175.  Available 

Beryllium 
beryllium 
https://circabc.europa.eu/sd/a/33c8921a-1dbe-4410-909c-2d4c63d8fb1d/REC-
175%20Beryllium%20and%20compounds.pdf 

compounds. 

inorganic 

and 

157 

 
 
 
                                                            
respiratory  effects  and  therefore  do  not  represent  critical  endpoints.    Information  on 
reproductive  toxicity  is  largely  lacking,  but  the  sparse  data  available  do  not  indicate 
effects on fertility or developmental toxicity.142 

Arsenic acid and its salts, as well as inorganic arsenic compounds 

Chromium copper arsenate (CCA)-treated timber, copper smelting (of lower grade ores) 
and  metal  extraction  and  handling  of  mining  waste,  have  become  the  most  prevalent 
sources of occupational exposure to arsenic. Occupational exposure to arsenic from CCA 
wood  preservatives  mainly  occurs  today  from  dismantling  of  wooden  structures  and 
recycling of wood, as treatment of wood and imports of CCA-treated timber in the EU is 
banned since 2013. 

Occupational  exposure  to  arsenic  may  also  be  significant  in  other  industries,  such  as 
arsenic  production,  electronics  (gallium  arsenide  semiconductors),  glass  manufacturing 
and in the pharmaceutical industry. 

Route of exposure 

Occupational  exposure  to  arsenic  acid  and  its  inorganic  salts  is  primarily  through 
inhalation of arsenic-containing particulates, but ingestion (skin-to-mouth) exposure may 
be  significant  in  particular  situations  (e.g.  CCA-treated  timber);  dermal  absorption  is 
considered  to  be  limited.143  It  is  extremely  rare  for  workers  to  be  exposed  to  arsenic 
alone; the exposure is usually to arsenic in combination with other elements144. 

Adverse health effects 

Arsenic  acid  and  its  salts  are  classified  as  Carcinogen  1A  under  the  Classification, 
Labelling and Packaging Regulation (EC) 1272/2008 (CLP Regulation), and the broader 
group arsenic, and inorganic arsenic compounds are considered to be human carcinogens 
(Group 1) by IARC. 

Inorganic arsenic compounds produce lung tumours in humans, following inhalation, oral 
or  parenteral  exposures.  Exposure  to  high  levels  of  inorganic  arsenic  compounds  in 
drinking water has been associated with skin, and urinary tract or bladder cancer or both 
in  humans.  Tumours  at  other  sites  including  the  adrenal  glands,  bladder  and  liver  have 
also been reported in some animal studies.  

Relevant  non-carcinogenic  endpoints  of  occupational  exposure  are  neurotoxicity  and 
cardiovascular  effects.  Immunotoxicity,  reproductive  and  developmental  effects  have 

142  RPA (2018) draft final report. Third study on collecting most recent information for a certain number 
of  substances  with  the  view  to  analyse  the  health,  socio-economic  and  environmental  impacts  in 
connection with possible amendments of Directive 2004/37/EC. 

143  RAC  (2017):  Opinion  on  Arsenic  acid  and  its  inorganic  salts  of  29  May  2017.  Committee  for  Risk 
at: 

Assessment, 
https://echa.europa.eu/documents/10162/13641/opinion_arsenic_en.pdf/dd3eb795-108e-5d3a-6847-
dddcc021a9dc 

Chemicals 

Available 

European 

Agency. 

144  WHO IPCS (2001): Environmental Health Criteria: 224 – arsenic and arsenic compounds. 2nd edition. 
World Health Organisation, Inter-Organization Programme for the Sound Management of Chemicals, 
Geneva, p. 66. 

158 

 
 
 
                                                            
been observed in animal studies with inhalation exposure, but to date there is no evidence 
for such endpoints in humans exposed by inhalation.145 

Formaldehyde 

Formaldehyde  is  used  in  a  wide  variety  of  sectors.  According  to  the  ECHA  substance 
information  portal,  formaldehyde  is  used  in:  adhesives  and  sealants;  coating  products; 
polymers;  biocides;  laboratory  chemicals;  polishes  and  waxes;  fuels;  washing  and 
cleaning  products;  cosmetics  and  personal  care  products.  Formaldehyde  is  used  in  the 
manufacturing  of  leather  or  fur,  pulp,  paper  and  paper  products,  textile  and  wood  and 
wood products and is also used in building and construction work.146 

Formaldehyde  is  also  used  for  tissue  preservation,  in  embalming  fluids  and  as  a 
disinfectant in pathology departments and autopsy rooms usually in the form of formalin 
(i.e.  mixture  of  formaldehyde,  water,  and  methyl  alcohol).    Formaldehyde  can  also  be 
used in the form of a polymerized solid - paraformaldehyde, which tends to be favoured 
in industrial applications in plants that are located at long distances from formaldehyde 
manufacturing  plants,  due  to  its  lighter  weight  and  lower  shipping  costs  (IARC,  2012; 
RPA, 2006).   

Route of exposure 

Formaldehyde  can  be  inhaled,  ingested  and  absorbed  through  the  skin.  Inhalation  is 
considered  to  be  the  main  route  of  exposure  of  exogenous  formaldehyde.  As  critical 
effects associated with formaldehyde exposure are directly linked to the contact surface, 
the oral pathway may not be negligible.147 

Adverse health effects 

As  a  result  of  its  reactivity  in  target  tissues  with  direct  contact  with  the  substance, 
formaldehyde  causes  local  irritation,  acute  and  chronic  toxicity  and  has  genotoxic  and 
cytotoxic  properties.  It  is  classified,  based  on  the  CLP  Regulation,  as  a  Cat.1B 
carcinogen (H350 "May cause cancer").  

According to RAC, formaldehyde is a local acting genotoxic carcinogen. RAC states that 
there  is  limited  evidence  of  carcinogenicity  in  humans  mainly  from  the  positive 
association of nasopharyngeal tumours in one industrial cohort, but that there is sufficient 
evidence of carcinogenicity from animal studies148. 

SCOEL based its opinion for the proposed OEL on their assessment that formaldehyde is 
a genotoxic carcinogen, for which a mode-of-action based limit value can be derived. 

In addition, skin-sensitising properties are relevant in case of dermal exposure.   

145  See footnote 143. 
146  ECHA  (2017):  Formaldehyde  Substance  Information.  Available  at  https://echa.europa.eu/substance-

information/-/substanceinfo/100.000.002 

147  SCOEL  (2016):    Recommendation  from  the  Scientific  Committee  on  Occupational  Exposure  Limits 
for  Formaldehyde.  SCOEL/REC/125.  Available  at:  https://circabc.europa.eu/sd/a/2882e9bc-d52e-
4944-ac08-974b43957ed2/REC-125%20Formaldehyde.pdf 

148  RAC (2012): Opinion proposing harmonised classification and labelling at EU level of Formaldehyde. 
at: 

Committee 
https://echa.europa.eu/documents/10162/254a73cf-ff8d-4bf4-95d1-109f13ef0f5a 

European  Chemicals  Agency.  Available 

for  Risk  Assessment, 

159 

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

MOCA is used primarily in the polyurethane industry (manufacture of polyurethane and 
plastic  products.  Typical  products  made  with  MOCA-based  cast  polyurethanes  include 
wheels, power transmission belts, gaskets or pump impellers. 

Route of exposure 

The most important occupational exposure route for MOCA is via dermal exposure after 
contact  with  contaminated  surfaces.  Inhalation  and  ingestion  represent  minor  routes  of 
occupational exposure. 

The substance is easily absorbed via the skin. Therefore a “skin” notation149 is warranted.  

Adverse health effects 

MOCA is classified, based on the CLP Regulation, as a Cat. 1B carcinogen (H350 "May 
cause  cancer")  and  has  been  classified  by  IARC  as  a  Group 1-  carcinogen  to  humans, 
taking also into account mechanistic and other relevant data150. As an aromatic amine, the 
reasonable  human  target  of  carcinogenicity  is  the  urothelium.  This  is  supported  by 
limited data in humans  and by the induction by MOCA of urothelial carcinomas in the 
dog,  which  is  known  from  experiments  with  other  aromatic  amines,  which  are  clear 
human  carcinogens  (benzidine,  2-naphthylamine),  to  respond  in  this  respect  similar  to 
humans. 

Very  few  data  are  available  regarding  non-carcinogenic  toxic  effects  of  MOCA.  In 
occupationally  exposed humans,  haematuria  has  been  described  with  no  further  details, 
but  otherwise,  even  after  long-term  occupational  exposure,  no  non-neoplastic  chronic 
effects. 

149  A  skin  notation  is  assigned  to  substances  for  which  the  dermal  route  of  exposure  is  scientifically 

considered to be relevant. 

150   IARC (2008) Monograph: Some aromatic Amines, Organic Dyes, and Related Exposures. Available 

at:  https://monographs.iarc.fr/ENG/Monographs/vol99/mono99.pdf 

160 

 
 
 
 
 
 
 
                                                            
Annex 9 - 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 amendment for the establishment and/or revision of binding occupational limit 
values  in  Annex  III  of  the    Carcinogens  and  Mutagens  Directive.  Annex  2  provides 
further information on the outcomes of the consultation.  

Step 2:  Priority  setting 

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

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.  In  this  proposal  for  example,  concerning 
formaldehyde although an impact on cancer prevention is somewhat limited, it will have 
a  major  impact  on  prevention  of  other  relevant  non-cancer  health  problems  such  as 
sensory  irritation  (preventing  around  19  200  cases)  which  otherwise  would  cause 
sufferings to these workers and compromise their quality of life. As formaldehyde (and 
the other four substances) falls under CMD, in order to prevent the whole range of health 
problems, an OEL can only be established under this directive. 

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

161 

 
 
Step 3:  Scientific evaluation and public consultation 

Article 16 of the CMD, which states that scientific/technical data should be included in 
the basis on which OELs are set, does not determine which scientific body should be the 
source  of  such  data.  With  a  view  to  mainstream  scientific  advice  and  in  line  with  the 
Commission Communication on "Safer and Healthier Work for All" of 10 January 2017, 
the  Commission  seeks  advice  from  both  the  Scientific  Committee  on  Occupational 
Exposure  Limits  (SCOEL)  or  the  Committee  for  Risk  Assessment  (RAC)  of  the 
European Chemical Agency (ECHA).  Scientific information from other sources can also 
be used as part of the scientific evaluation process as long as the data is adequately robust 
and is  in  the public domain (e.g.  IARC  monographs or  conclusions of national  OELV-
setting science committees). 

SCOEL  or  RAC  carry  out  a  scientific  evaluation  at  EU  level  and  as  a  result  publish  a 
single evaluation document (respectively a Recommendation or Opinion) for hazardous 
chemicals where there is priority concern for worker protection.   

SCOEL and RAC procedures for the adoption of a Recommendation/Opinion include an  
external consultation of relevant stakeholders with identified contact points in all of the 
Member  States;  this  ensures  scrutiny  of  the  scientific  evidence  and  methodological 
approach and ensures transparency of the process. 

Further Information on the SCOEL methodology is available at: 

http://ec.europa.eu/social/main.jsp?catId=148&intPageId=684&langId=en 

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 

In  the  case  of  the  carcinogens  considered  in  this  report,  SCOEL  concluded  scientific 
evaluations  (recommendations)  on  the  following  3  substances:  formaldehyde,  cadmium 
and beryllium, while RAC provided scientific evaluations (opinions) on arsenic acid and 
its salts and MOCA- further details are provided in Annex 1. 

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. 

162 

 
 
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 
including  adopted  SCOEL 
Recommendations/ RAC Opinions and any national OELs.  

limit  values 

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  the  adopted  SCOEL  Recommendations/  RAC  Opinions  (and/or 
other appropriate scientific evidence) and adopted a formal Opinion. 

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

The  ACSH  has  adopted  opinions  for  all  priority  substances  foreseen  for  the  third 
amendment  of the CMD151, proposing  a binding OEL for all  of them and in addition a 
skin notation for MOCA 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 

In  2017  an  external  contractor  evaluated,  on  behalf  of  the  Commission,  health,  socio-
economic  and  environmental  aspects  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 

151  The exact text of the opinions can be found  on CIRCA-BC under the following links: 

Formaldehyde: https://circabc.europa.eu/sd/a/25162551-6341-46d1-9e90-
4360cd6a1d0d/Doc.1280_EN-WPC%20June%20Opinion%20Formaldehyde.pdf 
Beryllium: https://circabc.europa.eu/sd/a/7e95cab5-6c71-4cbc-8147-f1f6d460ba2f/Doc.662-17-
EN_WPC_Opinion%20on%20Be_Adopted%2031.05.2017.pdf 
Cadmium: https://circabc.europa.eu/sd/a/bf0521f0-b54a-4712-b256-a30d7adcfdf6/Doc.663-17-
EN_WPC%20Opinion%20Cadmium_Adopted%2031.05.2017%20.pdf 

  MOCA: https://circabc.europa.eu/sd/a/2214b88e-5a69-4c2e-a98a-331aa13dc264/Doc.1336_EN-

WPC_Opinion%20MOCA_Adopted%2019102017.pdf 
Arsenic acid and its salts: https://circabc.europa.eu/sd/a/9813acc5-604a-49f9-9d4b-
afaeceb12705/Doc.1334_01_EN_WPC_Opinion%20Arsenic_Adopted%2019102017.pdf 

163 

 
 
                                                            
 
 
 
 
agreements  reached  in  the  Advisory  Committee  would  be  put  forward  in  the  eventual 
Commission's proposal. However, in line with the Better Regulation guidelines, an IA is 
conducted before presenting the proposal. In the IA the Commission verifies the ACSH 
opinions on the basis of a dedicated study. Other sources of information and data are duly 
taken into account at this stage.  

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

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

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

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

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

After  completion  of  these  steps  the  Commission  prepares  and  adopts  the  legislative 
procedure which then follows the ordinary legislative procedure for adoption. 

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  ensurethat  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. 

164 

 
 
 
 
 
Annex 10 - Consistency and synergies with the REACH 
Regulation 152 

The REACH Regulation, adopted in 2006, consolidated and evolved several parts of the 
EU  chemicals  legislation  –  principally  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. 

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

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.153 

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 

152  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. 

153  ECHA  2012  (updated  2016):  Guidance  on  Information  Requirements  and  Chemical  Safety 
Assessment,  Chapter  R.8.  Available  at:  https://echa.europa.eu/guidance-documents/guidance-on-
information-requirements-and-chemical-safety-assessment 

165 

 
 
 
                                                            
 
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  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 intermediates154 and unintended process generated substances. The former is for 
example  very  relevant  for  formaldehyde,  which  is  predominantly  used  as  a  chemical 
intermediate. 

Intermediates  as  defined  by the REACH  Regulation  are chemical substances  which are 
manufactured  for  and  consumed  in  or  used  for  chemical  processing  in  order  to  be 
transformed  into  another  substance155.  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. 

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'156 adopted on 
27-28 June 2016.157 

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 

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

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

155  Article 3(15) of REACH. 
156  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. 
157  European Commission (2016): REFIT Platform Opinion. Available at: 

https://ec.europa.eu/info/files/refit-platform-recommendations-chemicals-ii2a-reach-osh_en 

166 

 
 
                                                            
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. 

Status of the substances under the REACH Regulation 

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

The placing on the market and use of cadmium and its inorganic compounds in various 
mixtures and articles has been restricted since 1991, with several amendments:  

Name of agent in Annex XVII 

Entry No. 

Conditions of the restriction 

Cadmium and its compounds  23 

https://echa.europa.eu/documents/101
62/3bfef8a3-8c97-4d85-ae0b-
ac6827de49a9 

Cadmium  compounds  are  also  SVHCs  on  the  candidate  list  for  possible  inclusion  in 
Annex XIV to the REACH Regulation: 

Name of agents in the candidate 
list 

CAS No. 

EC No. 

Identified 
SVHC 

as 

Cadmium 

7440-43-9 

231-152-8 

20/06/2013 

Cadmium chloride 

10108-64-2 

233-296-7 

16/06/2014 

Cadmium fluoride 

7790-79-6 

232-222-0 

17/12/2014 

Cadmium oxide 

1306-19-0 

215-146-2 

20/06/2013 

Cadmium sulphate 

10124-36-4,  

233-331-6 

17/12/2014 

31119-53-6 

Cadmium sulphide 

1306-23-6 

215-147-8 

16/12/2013 

167 

 
 
 
 
 
Arsenic acid and its salts are subject to authorisation (Annex XIV) : 

Name of agents in Annex XIV 

CAS No. 

EC No. 

Sunset date158 

Arsenic acid 

7778-39-4 

231-901-9 

22/08/2017 

Diarsenicpentaoxide 

1303-28-2 

215-116-9 

21/05/2015 

Diarsenic trioxide 

1327-53-3 

215-481-4 

21/05/2015 

Arsenic compounds are also restricted in placing on the market and use for the treatment 
of wood: 

Name of agent in Annex XVII 

Entry No. 

Conditions of the restriction 

Arsenic compounds 

19 

https://echa.europa.eu/documents/10
162/a798c758-371f-41e5-a38d-
5f8dc9ba739d 

4,4'-Methylene-bis(2-chloroaniline) (MOCA) is subject to authorisation (Annex XIV) : 

Name of agent in Annex XIV  CAS No. 

EC No. 

Sunset date 

2,2'-dichloro-4,4'-
methylenedianiline 

101-14-4 

202-918-9 

22/11/2017 

Beryllium and inorganic beryllium compounds  and formaldehyde are currently not 
identified as SVHC or subject to restrictions under the REACH Regulation. 

158  Date from which the placing on the market and the use of that substance shall be prohibited unless an 

authorisation is granted. 

168