COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Council Directive 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council as regards the limit values for lead and its inorganic compounds and diisocyanates
Date: 2023-02-13
Institutions: Directorate-General for Employment, Social Affairs and Inclusion, European Commission
Subjects: chemical compound, health risk, lead, occupational safety, reproductive health, respiratory disease, safety standard, toxic substance

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 13.2.2023  SWD(2023) 35 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT  Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Council Directive 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council as regards the limit values for lead and its inorganic compounds and diisocyanates   {COM(2023) 71 final} - {SEC(2023) 67 final} - {SWD(2023) 34 final} - {SWD(2023) 36 final}  
 
 
Table of contents 

1. 

2. 

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

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

2.1 What is/are the problem(s)? ...................................................................................3 
2.2 What are the problem drivers? ...............................................................................5 
2.3 How will the problem evolve? .............................................................................12 

3.  WHY SHOULD THE EU ACT? ......................................................................................................... 14 

3.1 Legal basis ...........................................................................................................14 
3.2 Subsidiarity: Necessity and added value of EU action ........................................15 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ................................................................................ 16 

4.1 General objectives ................................................................................................16 
4.2 Specific objectives ...............................................................................................16 
4.3 Consistency with other EU policies .....................................................................16 

5.  WHAT ARE THE POSSIBLE POLICY OPTIONS? .......................................................................... 18 

5.1 Process for setting binding limit values under the CAD and the CMRD ............18 
5.2 Baseline Scenario .................................................................................................18 
5.3 Options discarded at an early stage ......................................................................20 
5.4 Policy options ......................................................................................................21 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ............................................................ 23 

6.1 Analytical methodology .......................................................................................23 
6.2 Social impacts ......................................................................................................24 
6.3 Economic impacts ................................................................................................27 
6.4 Impacts on the environment and on climate change ............................................34 
6.5 Impacts on fundamental rights .............................................................................35 
6.6 Contribution to sustainable development ............................................................35 
6.7 Impacts on digitalisation ......................................................................................35 
6.8 Administrative impacts ........................................................................................36 
6.9 ‘One in, one out’ approach ..................................................................................36 
6.10 Summary of the impacts ....................................................................................36 

7.  HOW DO THE OPTIONS COMPARE? ............................................................................................. 40 

8. 

PREFERRED OPTION ....................................................................................................................... 44 

8.1 Lead .....................................................................................................................44 
8.2 Diisocyanates .......................................................................................................44 
8.4 Subsidiarity, proportionality and REFIT .............................................................46 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 48 

 
 
 
 
9.1 Monitoring arrangements .....................................................................................48 
9.2 Evaluation arrangements ......................................................................................50 

ANNEX 1: PROCEDURAL INFORMATION ............................................................................................. 51 

ANNEX 2: STAKEHOLDER CONSULTATION ....................................................................................... 56 

ANNEX 3: WHO IS AFFECTED AND HOW? ........................................................................................... 65 

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

ANNEX 5: RELEVANT SECTORS, USES AND EXISTING LIMIT VALUES ....................................... 87 

ANNEX 6: SMES .......................................................................................................................................... 99 

ANNEX 7: PROCESS FOR SETTING BINDING OELS, BLVS AND ASSOCIATED PROVISIONS .. 102 

ANNEX 8: CONSISTENCY AND COMPLEMENTARITY WITH THE REACH REGULATION ........ 107 

 
 
 
 
ACSH 
ALIPA 
BLV 
CAD 
CMRD 
CSS 
DALY 
DNEL 
DRR 
ECHA 
EFBWW 
EIG 
ERR 
EU 
FIEC 
GIG 
ILA 
ISG 
ISOPA  
LAB 
NCO 
NGO 
OEL 
OSH 
PbA 
PbB 
RAC 
REACH 

RMM 
SDG 
SEA Europe 
SME United 
STEL  
SVHC 
TWA 
WIG  
WTP 

Glossary  

Advisory Committee on Safety and Health at Work 
European Aliphatic Isocyanates Producer Association 
Biological Limit Value 
Chemical Agents Directive 
Carcinogens, Mutagens and Reprotoxicants Directive 
Chemicals Strategy for Sustainability 
Disability Adjusted Life Years 
Derived No Effects Level  
Dose response relationship 
European Chemicals Agency 
European Federation of Building and Woodworkers 
Employers Interest Group of ACSH 
Exposure Risk Relationship 
European Union 
European Construction Industry Federation 
Government Interest Group of ACSH 
International Lead Association 
Inter-service group 
European Diisocyanate and Polyol Producers Association 
Lead acid batteries 
Diisocyanate active group – Nitrogen, Carbon, Oxygen 
Non-governmental organisation 
Occupational Exposure Limit – 8 hour time-weighted average exposure 
Occupational Safety and Health 
Lead in air 
Lead in blood 
Risk Assessment Committee 
Regulation on the Registration, Evaluation and Authorisation of 
Chemicals 
Risk Management Measures 
UN Sustainable Development Goal 
Shipyards’ & Maritime Equipment Association of Europe  
European Association of Crafts and SMEs  
Short term exposure limit – normally time averaged over 15 minutes  
Substance of very high concern 
Time-Weighted Average 
Workers Interest Group of ACSH 
Willingness To Pay 

 
 
 
 
 
1.  1. INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

A strong social Europe calls for constant improvements towards safer and healthier work for all. Over 
the last years, the European Union (EU) occupational  safety and health (OSH) policy framework and 
rules have contributed to considerably improving working conditions, in particular concerning workers’ 
protection  from  exposure  to  carcinogens  and  other  hazardous  chemicals1.  Exposure  limit  values  and 
other  provisions  have  been  set  or  revised  for  many  substances  or  groups  of  substances  under  the 
Carcinogens, Mutagens and Reprotoxic Substances Directive 2004/37/EC (CMRD)2 and the Chemical 
Agents Directive 98/24/EC3 (CAD).  

Ensuring  healthy  and  safe work  environments  is  vital  to  protect  workers,  uphold  productivity,  and  to 
allow for a sustainable economic recovery. The Commission announced in the European Pillar of Social 
Rights Action Plan4 the intention to ensure a healthy, safe and well adapted work environment,  which 
was  confirmed  with  the  adoption  of  the  OSH  Strategic  Framework  for  2021-20275.  Also,  the  2020 
Chemicals  Strategy  for  Sustainability  (CSS)6  recognises  the  need  to  strengthen  the  protection  of 
workers and identifies lead and diisocyanates among the priority chemicals to act upon.  

The external stakeholder consultation on the evaluation of the previous EU OSH strategy for the period 
2014–2020  confirmed  that  preventing  work-related  diseases  is  a  common  goal  requiring  coordinated 
actions including the need to continuously update binding occupational exposure limits (OELs)7 8. 

Lead  and  its  inorganic  compounds  (referred  to  throughout  this  report  as  ‘lead’)  are  key  occupational 
reprotoxicants that can affect both fertility and the development of the foetus9. The current EU binding 
OEL  is  0.15  mg/m³  and  the  biological  limit  value  (BLV10)  is  70  µg/100  ml  blood.  These  were  first 
introduced  under a  specific  directive  on lead  in  198211  and  have  not  been  updated  for  over  40  years. 
They therefore do not take into account the latest scientific and technical developments and findings.  

Diisocyanates  are  skin  and  respiratory  sensitisers  (asthmagens)  that  have  the  potential  to  cause 
occupational  asthma  and  dermal  occupational  disease12.  Currently  there  is  no  binding  OEL  or  short-
term exposure limit value (STEL13) for diisocyanates at EU level.  

1 The EU OSH Strategic Framework on Health and Safety at Work 2014-2020, COM (2014) 332 final, 6.6.2014; 
the  Commission  Communication  ‘Safer  and  Healthier  Work  for  All  -  Modernisation  of  the  EU  Occupational 
Safety and Health Legislation and Policy’, COM (2017) 12 final, 10.1.2017; the Commission Communication ‘A 
strong social Europe for just transitions’, COM(2020) 14 final, 14.1.2020, the EU Strategic Framework on health 
and safety at work 2021-2027, COM (2021) 323 final 28.7.2021.  
2 Directive 2004/37/EC . 
3 Directive 98/24/EC . 
4 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52021DC0102&from=EN  
5 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021DC0323&from=EN    
6 https://ec.europa.eu/environment/pdf/chemicals/2020/10/Strategy.pdf   
7 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021SC0149&from=EN  
8 OEL means the limit of the time-weighted average of the concentration of a chemical agent in the air within the 
breathing zone of a worker in relation to a specified reference period, normally 8 hours. 
9  The  reproductive  health  toxicity  of  inorganic  lead  compounds  is  due  to  their  lead  content.  Therefore,  a  group 
approach is supported by the RAC to cover a broad range of individual lead containing substances.  
10  BLV  means  the  limit  of  the  concentration  in  the  appropriate  biological  medium  of  the  relevant  agent,  its 
metabolite, or an indicator of effect. 
11 Council Directive 82/605/EEC  
12  Diisocyanate  substances  have  a  common  mechanism  of  inducing  hypersensitivity  mechanisms.  Therefore,  a 
group approach is supported by RAC to cover a broad range of individual diisocyanate substances.  

1 

 
 
                                                      
The setting of limit values at EU level provides an objective measure that can be used to demonstrate 
effective  control  of  risks  to  workers’  health.  Inadequate  control  of  hazardous  chemicals  at  the 
workplace  has  a  negative  impact  on  workers,  and  it  is  also  associated  with  significant  costs  to 
individuals  and  society  as  a  whole.  Good  OSH  is  essential  not  only  to  minimise  ill-health  but  also 
associated costs14. 

This  OSH  initiative  will  contribute  to  the  sustainable  development  goals  (SDG)  on  good  health  and 
well-being  (3rd  goal),  on  decent  work  and  economic  growth  (8th  goal),  on  industry,  innovation  and 
infrastructure (9th goal) and on responsible production and consumption (12th goal). 

When the preparatory work for this initiative started, both substances were in the scope of the CAD and 
the aim was to amend only this Directive. However, following the agreement in March 2022 between 
the  European  Parliament  and  Council  during  the  fourth  revision  of  the  Carcinogens  and  Mutagens 
Directive (CMD) to extend its scope to reprotoxic chemicals, lead is now in the scope of the CMRD.15 
Consequently, the main legislative tools to ensure workers' protection against risks related to exposure 
to lead and diisocyanates are the CMRD and the CAD respectively. 

In  order  to  carry  out  this  impact  assessment,  the  Commission  contracted  a  study16  (referred  to 
throughout this report as the ‘external study’) in order to collect the most recent information. 

To  support  its  work,  the  Commission  requested  a  scientific  evaluation  by  the  Risk  Assessment 
Committee  (RAC)  of  the  European  Chemicals  Agency  (ECHA)  and  an  opinion  of  the  tripartite 
Advisory  Committee  for  Safety  and  Health  at  Work  (ACSH).  The  opinions  of  the  ACSH  take  into 
account the scientific basis and provide the Advisory Committee’s view on feasibility factors, which are 
indispensable to underpin OSH legislation. 

The  Commission’s  analysis  also  takes  into  account  views  received  through  the different channels  for 
consultation,  including  the  formal  two-stage  consultation  of  the  social  partners  and  the  views  of 
stakeholders received in response to the call for evidence. In addition, the  analysis takes into account 
the complementary benefits stemming from the recently adopted restriction under the Regulation on the 
Registration,  Evaluation  and  Authorisation  of  Chemicals  (REACH)17  that  requires  the  mandatory 
training of workers who may be exposed to diisocyanates. This contributes to the common aim of OSH 
and REACH to replace harmful chemicals by less harmful ones.  

The  purpose  of  this  impact  assessment  is  to  assess  whether  there  is  a  need  to  revise  the  level  of 
protection  offered  by  the  CMRD  and  the  CAD  by  revising  the  existing  limit  values  for  lead  and  to 
introduce,  for  the  first  time,  a  limit  value  for  diisocyanates18,  as  well  as  which  would  be  the  most 
appropriate levels to take forward. For more details on limit values, see Annex 7.  

13 A STEL is usually referenced to a 15-minute period and is used when short duration exposures, such as peaks, 
are relevant to the onset of ill-health. 
14 https://www.prevent.be/en/knowledge/research-project-on-the-benefits-of-osh  
15 Directive (EU) 2022/431 
16  RPA  (2021).  Study  on  collecting  information  on  substances  with  the  view  to  analyse  health,  socio-economic 
and  environmental  impacts  in  connection  with  possible  amendments  of  Directive  98/24/EC  (Chemical  Agents) 
and Directive 2009/148/EC (Asbestos).   
17 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1907-20220501  
18 Diisocyanates is a collective term for a number of individual diisocyanates chemicals. This includes at least 25 
different diisocyanates, of which 11 account for over 99% of the registered tonnage under REACH (ECHA 2019). 

2 

 
 
 
                                                                                                                                                                        
Box 1: Definitions of key technical terms 

Occupational Exposure Limits 
OELs are the limit of the Time-Weighted Average (TWA) of the concentration for a chemical in the 
air  within  the  breathing  zone  of  a  worker  in  relation  to  a  specified  reference  period  (normally  8 
hours). 
Short Term Exposure Limits 
STEL values, usually involving a 15-minute reference period, are used when adverse health effects 
are  not  adequately  controlled  by  compliance  with  an  8-hour  TWA  OEL,  e.g.,  for  substances  for 
which a critical effect is observed following a brief exposure (for example, acute toxic substances, 
substances causing nuisance, irritation, central nervous system depression, sensitisation). 
Biological Limit Values 
BLVs are the limit of the concentration in the appropriate biological medium of the relevant agent, its 
metabolite, or an indicator of effect (in the case of lead, in the blood of the exposed worker). 
Notations 
OELs, STELs and/or BLVs can further be annotated with appropriate indications of additional body 
burden resulting from non-inhalation routes such as, for example, a 'skin' notation where the dermal 
route of exposure is scientifically considered to be relevant. 

2.  2. PROBLEM DEFINITION 

2.1 What is/are the problem(s)? 

The 2017 ex-post evaluation of the EU OSH directives19, including the CAD and the CMD, concluded 
that  the  directives  remain  highly  relevant  and  effective  according  to  the  available  evidence.  It 
highlighted that limit values are an important tool for chemical risk management at the workplace and 
that  there  is  a  need  to  adopt  exposure limit  values  for  more  substances  of  high  concern, in  particular 
carcinogenic,  mutagenic  and  reprotoxic substances. Specifically,  it  identifies  the  need to  consider  the 
most  appropriate  approach  to  managing  risks  that  may  arise  from  exposure  to  reprotoxic  substances, 
and if and how biomonitoring could be used more effectively for workplace risk management. It further 
states that sensitisers20 should be considered as a high priority that merit further consideration to ensure 
that  the  risk  management  requirements  are  appropriate.  However,  whilst  the  evaluation identified  the 
main issues, it did not provide the required detailed quantitative data. 

This  initiative  is  also  in  line  with  the  stocktaking  staff  working  document  accompanying  the  EU 
strategic framework on health and safety at work 2021-2027 (SWD (2021) 148 final) which identifies 
the need to increase the focus on addressing occupational diseases. In particular, for lead it states that 
the limit values should be reviewed in light of new scientific data. 

Lead  is  a  key  occupational  reprotoxicant  that  can  affect:  i)  sexual  function  and  fertility  and  ii)  the 
development  of  the  foetus  or  offspring  (developmental  toxicity).  Exposure  to  lead  may  result  in 
impaired  fertility,  miscarriages,  or  serious  birth  defects,  not  to  mention  other  harmful  effects  such  as 

19 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52017SC0010&from=en  
20  Sensitisers  can  cause  adverse  reactions,  including  asthma,  as  a  result  of  inhalation  or  absorption  through  the 
skin of a foreign substance to which the exposed person has been previously sensitised. 

3 

 
 
 
 
 
                                                      
neurotoxicity,  renal  toxicity,  cardiovascular  effects  and  haematological  effects.  Lead  accounts  for 
around half of all occupational exposures to reprotoxic substances and associated cases of reproductive 
ill-health21. 

Diisocyanates  are  skin  and  respiratory  sensitisers  (asthmagens)  that  cause  occupational  asthma  and 
dermal  occupational  disease  –  allergic  reactions  that  can  occur  due  to  exposure  to  such  substances. 
They  can  cause  people’s  airways  to  change  (the  'hypersensitive  state').  Once  the  lungs  become 
hypersensitive, further exposure to the substance, even at quite low levels, may trigger an asthma attack.  

Studies have estimated that occupational factors account for approximately 9-15% of asthma cases in 
adults of working age22. Diisocyanates are one of the most common causes of occupational asthma with 
an estimated number of annual incidences of diisocyanate-related occupational asthma in the EU in the 
range from 2 350 to 7 269 cases 23 24 25. 

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

on 

Study 

21 
substances 
https://ec.europa.eu/social/main.jsp?catId=738&langId=en&pubId=8220&furtherPubs=yes  
22 Balmes J, Becklake M, Blanc P et al. (2003) American Thoracic Society Statement: occupational contribution 
to the burden of airway disease. Am J Crit Care Med. 167:787- 797. 
23 https://www.hse.gov.uk/statistics/causdis/asthma.pdf  
24 https://academic.oup.com/annweh/article/65/8/893/6247067  
25 As per footnote 16 -RPA study 2021 (external study supporting this Impact Assessment). 

reprotoxic 

(2019) 

4 

 
 
                                                      
External market drivers (Green 
Deal) 

Lead:  The  transition  to  electric 
vehicles resulting in greater use of 
battery technologies. 

Diisocyanates:  Renovation  Wave 
promoting 
building 
enhanced 
insulation. 

Diisocyanates:  Use  of 
lighter 
materials  in  vehicle  components 
to offset weight of batteries. 

Internal market driver 

Internal regulatory drivers 

 Exposure of workers 

to hazardous 
chemicals represents 
a significant risk to 
workers’ health. 





The EU limit values for lead 
is out of date. 
There is no EU limit value 
for diisocyanates. 
 Different levels of 

protection exist in Member 
States.  

Lead  and  diisocyanates  are  a  major  contributor 
occupational 
causing 
problems and asthma respectively. 

to 
reproductive  health 

ill-health 

 For businesses: 

 For Member States: 

 For workers: 

 Higher  costs  (absenteeism, 
need  for  staff  replacement, 
loss of experience). 

 Reduced staff productivity. 
 Lack of level playing field. 

 Higher social 
security costs. 

 Forgone tax 
revenues. 

 Reduced quality of life. 
 Personal health problems. 
 Higher health related costs. 
 Reduced family income. 

s
r
e
v
i
r
d

m
e
l
b
o
r
p

s
e
c
n
e
u
q
e
s
n
o
c

2.2 What are the problem drivers? 

2.2.1 

Internal market drivers 

This  section  presents  the  uses  and  the  estimated  numbers  of  exposed  workers  per  substance  (more 
information is provided in Annex 5). 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. 

2.2.1.1 Lead  

Lead is currently used for a large variety of applications. In addition, workers may be exposed to lead at 
significant levels due to historic applications in activities such as renovation, waste collection, recycling 
and remediation26. It is estimated that approximately 50 000 to 150 000 workers in the EU are exposed 
to  lead.  Determining  a  precise number  is difficult  because  workers in  sectors such  as  demolition  and 

26 The REACH Regulation prohibits the use of lead in paints, subject to certain derogation (Annex 8). However, 
workers may be exposed to lead when working on buildings and structures that were painted prior to the entry into 
force of the restriction.   

5 

 
 
 
                                                      
 
 
 
 
waste management, and those using articles of lead metal may only occasionally be exposed to lead, but 
sometimes at relatively high levels. Approximately 300 cases of ill-health occur each year as a result of 
past  occupational  exposure  to  lead.  This  exposure  is  important  due  to  the  possibility  of  lead  to 
accumulate  in  the  bones,  thus  contributing  to  the  overall  body  burden  and  likelihood  of  chronic  ill-
health. 

The main sectors for industrial production and use of lead are primary and secondary lead production 
(including battery recycling); battery, lead sheet and ammunition production; production of lead oxides 
and frits; and lead glass and ceramics production. Exposure to lead is also possible in other industrial 
applications, such as foundries and production of articles of alloys with lead, and production and use of 
pigments for paint and plastics. Besides these applications, exposure may take place further downstream 
in the product chain and when the articles and materials become waste or during the waste recovery of 
recycled materials. Examples of downstream activities are applications of paints; shooting; work with 
lead  metal;  demolition,  repair  and  scrap  management;  other  waste  management  and  soil  remediation; 
and work in laboratories. 

Company size is variable and is often sector specific. For example, there are: 6 primary lead production 
companies that are all large companies (more than 249 employees) and 30 lead battery manufactures, of 
which  80%  are  large  and  20%  medium  sized  companies.  For  most  other  sectors  using  lead,  the 
companies are mainly SMEs.  

The  primary  routes  of  occupational  exposure  are  by  inhalation  and  by  ingestion  by  hand-to-mouth 
behaviour  due  to  insufficient  personal  hygiene  and  housekeeping  (e.g.,  a  worker  with  contaminated 
hands  who  does  not  thoroughly  wash  them  before  eating  or  smoking).  Dermal  absorption  of  lead  is 
considered to be minimal. Exposure by ingestion is considered significant and this exposure route is an 
important driver for the development of ill-health. Lowering the OEL is specific to inhalation exposure 
and additional measures are needed to minimise ingestion exposure. For that, blood lead concentrations 
are recognised as the best exposure metric to assess occupational exposures to lead, since internal lead 
levels are decisive for determining the overall risk to health. 

Data  indicates  that  the  exposed  workforce  is  predominantly  male,  especially  in  key  sectors  such  as 
primary lead production, secondary lead production, lead battery production and lead sheet production 
(c.95-97%).  The  female  workforce  is  around  3%,  with  the  exception  of  lead  crystal  glass  production 
(12%). However, the total size of the corresponding workforce is relatively small compared to the key 
sectors where lead is used. Even though the share of female workforce is relatively small, the gender 
dimension  is  very  important.  The  negative  impact  of  lead  is  double  as  it  can  affect  women  and,  in 
addition, it affects the developing foetus in pregnant women27. There are existing requirements in the 
Pregnant Workers Directive28. However, they only apply from when the worker informs their employer 
that they are pregnant, typically three months into the pregnancy. Within the lead industry, awareness of 
workers  of  childbearing  capacity  and  the  need  to  have  specific  measures  in  place  to  minimise  any 
possible risks is expected to already be an integral part of the employers’ approach to risk management.  

Compliance  with  the  BLV  is  the  primary  tool  for  protecting  workers  from  lead  toxicity.  Oral  and 
inhalational exposure are both relevant routes for the uptake of lead into the human body. The OEL is 
needed to reduce the occupational exposure.  

The relationship between levels of lead in air (PbA) and blood (PbB) depends on various factors within 
an  occupational  setting  and  an  unambiguous  correlation  between  these  two  metrics  is  not  apparent. 

27 Lead can pass the placenta resulting in blood lead concentration in the umbilical cord at birth being close to the 
blood lead level of the mother (source: RPA, 2021 external study section 2.2.4.7). 
28 Council Directive 92/85/EEC https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31992L0085  

6 

 
 
                                                      
Exposure occurs through multiple routes and even if the concentration of lead in the air is quite low, 
internal levels may still be relatively high, reflected by the biological monitoring results. 

2.2.1.2 Diisocyanates 

Diisocyanates  are  used  in  manufacture  of  polyurethane  as  both  solids  and  foams,  plastics,  coatings, 
varnishes,  two-pack  paints  and  adhesives.  Workers  in  companies  manufacturing  these  materials  are 
exposed,  and  so  are  workers  using  adhesives,  sealants,  paints  and  coatings  containing  diisocyanates. 
These products are widely used in construction, vehicle repairs, general repairs, textiles, furniture, and 
the  manufacture  of  motor  vehicles,  other  transport,  domestic  appliances,  machinery  and  computers. 
Diisocyanates are transformed during the production process, and they are no longer present in the final 
manufactured  product  and,  therefore,  there  is  no  risk  to  the  user  of  the  product  (e.g.,  consumers). 
According  to  estimates29,  approximately  4.2  million  workers  are  exposed  to  diisocyanates  and  more 
than  2.4  million  companies  in  the  EU  are  concerned,  the  vast  majority  being  micro-enterprises  or 
SMEs. 

Currently,  there  are  19  individual  diisocyanate  substances  registered  under  REACH.  There  is  some 
variation in use between different diisocyanates. However, the three most produced diisocyanates (TDI, 
4,4’-MDI and 2,4’-TDI) are all aromatic isocyanates and they have a similar use pattern which consists 
of, for example, flexible and rigid foams, adhesives and sealants. Aliphatic isocyanates (HDI and IPDI) 
are  often  present  in  coatings  and  paints.  The  health  effects  are  caused  by  a  common  part  of  all 
diisocyanates (the NCO group30). Therefore, a grouping approach can be considered as it would allow 
for  a  common  OEL  and  STEL  for  all  diisocyanates31.  This  is  in  line  with  the  grouping  approach 
favoured by the recently adopted EU Chemicals Strategy for Sustainability. 

The predominant health effects of occupational exposure to diisocyanates are respiratory health effects 
(occupational  asthma,  isocyanate  sensitisation  and  bronchial  hyperresponsiveness),  which  are  the 
critical endpoints related to diisocyanate exposure occurring both after acute and long-term exposure. 
Peak exposures (short duration/high exposure levels) are a key influencing mechanism in the cause of 
occupational  asthma.  Therefore,  a  STEL,  which  best  addresses  repeated  short-duration  high-level 
exposures,  is  the  most  appropriate  regulatory  measure  to  address  this  type  of  exposure  pattern. 
However,  there  is  a  lack  of  robust  scientific  information  and  socio-economic  data  on  short-term 
exposures. For these reasons, RAC advised that any STEL should be maximally higher by a factor of 2 
than the OEL and the external study could only analyse the impacts of the OEL.  

In  these  situations,  information  on  the  safe  use  of  diisocyanates  and  its  correct  application  in  real 
workplaces will be critical to ensuring effective control of workers’ exposure whilst reducing the need 
for  exposure  monitoring  and  associated  costs.  This  will  be  relevant  for  some,  but  not  all,  transient 
exposures in temporary  workplaces  such  as construction.  In  part,  this is addressed  via  the  mandatory 
training requirements introduced by REACH for users of diisocyanates (see section 2.2.3.2). 

The introduction of an OEL and STEL would provide quantitative objectives to concretise the intention 
of  the  general  requirements  of  CAD.  This  is  important  for  determining  the  type  of  risk  management 
measures that should be introduced to ensure that exposure is effectively controlled. This aspect of the 
overall  approach  to  risk  management,  based  on  the  complementarity  of  CAD  and  REACH,  is  not 
specifically addressed by the REACH restriction, which is focussed on the training of workers. 

29 RPA, 2021. External study.  
30 The NCO group refers to the nitrogen, carbon, and oxygen atom of the isocyanate group. 
31 RAC and other scientific expert committees agree on an NCO grouping approach. 

7 

 
 
 
 
                                                      
2.2.2  External market drivers 

Lead battery manufacture is a key employment sector where workers may be exposed to lead. In 2017, 
the  European  Commission  launched  the  European  Battery  Alliance32.  Batteries  are  a  strategic  part  of 
Europe's clean and digital transition and a key enabling technology, essential to the automotive sector's 
competitiveness. This aims to make Europe a global leader in sustainable battery production and use. 
This was followed by a proposal33 to revise the Batteries Directive to minimise the negative impact of 
batteries and waste batteries on the environment, while ensuring the smooth functioning of the internal 
market. 

Between  2010  and  2018,  battery  demand  grew  by  30%  annually.  The  market  is  expected  to  keep 
growing, at an estimated 25% annual rate. The main drivers of demand growth are the electrification of 
transportation and the deployment of batteries in electricity grids34. In 2018, approximately 72% of the 
world rechargeable battery capacity was provided by lead-acid batteries (LABs). Approximately 65% of 
global demand for LABs is currently driven by automotive applications, with nearly every vehicle on 
the road currently requiring a LAB for starter, light and ignition functions. 

Automotive lead batteries have a recycling rate of 99%, they are one of the few consumer products that 
already operate in a closed loop (i.e., where all used batteries are collected, and the component parts are 
recycled  ready  for  reuse)35.  Increasing  demand  for  batteries  and  their  recycling  has  the  potential  to 
increase the number of exposed workers.  

For diisocyanates, the Renovation Wave Strategy under the European Green Deal36 is likely to result in 
greater use of insulating foams and better surface coatings to enhance the thermal insulation of the built 
environment. In addition, the manufacturers of electric vehicles are increasingly considering replacing 
heavier materials in cars with polyurethane to offset the weight of batteries. Polyurethane coatings are 
also  used  in  many  applications  including  the  rotor  surfaces  of  wind  turbines.  Sectors  manufacturing 
insulations  foams  and  coatings,  including  their  application,  are  key  sectors  using  diisocyanates. 
Increasing demand for these products has the potential to increase the number of exposed workers. 

2.2.3  Regulatory drivers 

The  CAD  and  the  CMRD  have  as  their  aim  the  protection  of  workers  against  risks  to  their  health, 
including the prevention of such risks, arising or likely to arise from exposure to hazardous substances 
at work, such as lead and diisocyanates. Since both substances are already covered by the Directives, 
the employer must assess the risks to workers’ health for all activities in which workers are or may be 
exposed to lead or diisocyanates and apply appropriate risk management measures (RMMs) to ensure 
effective  control  of  any  identified  risks.  The  limit  values  provide  an  important  objective  measure  to 
facilitate the implementation of the Directives and improve the protection of workers by reducing the 
level of exposures. 

For  some  hazardous  chemical  agents,  the  CAD  and  the  CMRD  establish  limit  values  (OELs/STELs) 
and in the case of lead, a BLV. The fact that limit values are established does not affect the obligations 
of  the  employer  to  comply  with  other  requirements  which  are  based  on  the  principles  of  good 
in  use,  enclose 
occupational  hygiene  practice,  such  as  to  minimise  amount  of  substance 

A 

32 https://ec.europa.eu/growth/industry/strategy/industrial-alliances/european-battery-alliance_en  
33 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020PC0798  
34 
(2019) 
https://www3.weforum.org/docs/WEF_A_Vision_for_a_Sustainable_Battery_Value_Chain_in_2030_Report.pdf  
35 https://www.eurobat.org/wp-content/uploads/2021/09/ihs_eurobat_report_lead_lores_final_2.pdf    
36https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0662  

Sustainable 

Battery 

Vision 

Chain 

Value 

2030 

for 

in 

a 

8 

 
 
                                                      
equipment/processes  where  possible  to  minimise  release,  maintain  in  good  condition  all  risk 
management systems such as ventilation controls, train and inform workers on risks and safe working 
practices. The exposure must be reduced to a minimum and in any case below the fixed binding limit 
values when those exist. 

In January 2019, the three Interest Groups (Workers’, Employers’ and Governments’) of the Working 
Party  ‘Chemicals  at  the  Workplace’  (WPC)  of  the  ACSH  agreed  that  lead  and  diisocyanates  are 
priorities for scientific evaluation by RAC. This is the first step in the process to revise the limit values 
for lead and to introduce, for the first time, limit values for diisocyanates37. The prioritisation of lead 
reflects growing concern about reprotoxic substances which resulted in their inclusion in the scope of 
the  CMRD  in  early  2022.  There  is  also  a  similar  concern  about  how  to  tackle  occupational  asthma. 
Diisocyanates  are  one  of  a  limited  number  of  key  occupational  asthmagens.  In  addition,  based  on 
extensive stakeholder consultation, both substances were identified under the prioritisation strategy of 
the EU Human Biomonitoring programme (HBM4EU 2017-2018)38, an EU Horizon 2020 initiative to 
build bridges between the research and policy worlds to enhance chemical safety. 

Under the CAD and the CMRD, the Commission evaluates the relationship between the health effects 
of  hazardous  chemical  agents  and  the  level  of  occupational  exposure  by  means  of  an  independent 
scientific assessment, the availability of measurement techniques, and feasibility factors. The aim is to 
protect the  health  of  workers  by  proposing  appropriate  binding  limit  values, including  inhalation  and 
biological limit values. New, or revised, limit values should be set on the basis of available information, 
including  up-to-date  scientific  and  technical  data.  This  scientific  evidence  became  available  in  June 
2020 when RAC adopted its opinions on lead and diisocyanates39 40.  

The  Commission  proposals  for  OELs  also  take  into  account  scientific-technical  feasibility  of 
monitoring  exposure,  including  the  availability  of  suitable  measurement  techniques.  Socio-economic 
and further technical feasibility factors are discussed in the  WPC. More information on the procedure 
for setting limit values is presented in section 5.1. Technical and feasibility evidence was provided by 
the  ACSH,  which  adopted  opinions  supporting  this  initiative  for  both  substances  on  24 November 
202141. For lead, there was not a consensus agreement between three Interest Groups of the ACSH on 
what  the  levels  of  any  revised  limit  values  should  be.  For  diisocyanates,  there  was  a  consensus 
agreement of the three Interest Groups. The views of the social partners in response to the formal two-
stage consultation and the responses to the call for evidence have also contributed to that evidence. 

2.2.3.1 Lead limit values are out-of-date 

For lead, the limit values in the CMRD are an OEL of 0.15 mg Pb/m³ and a BLV of 70 µg Pb/100 ml 
blood. They were first set in 198242 based on the scientific and technology knowledge available at that 
time.  The  directive  further  states  that  its  minimum  requirements  should  be  reviewed  based  on 
experience acquired and on technology developments in the relevant areas. 

37 Minutes of WPC meeting held on 22-23 January 2019. 
38 https://www.hbm4eu.eu/hbm4eu-substances/2-prioritisation-process/  
39 https://echa.europa.eu/documents/10162/ed7a37e4-1641-b147-aaac-fce4c3014037  
40 https://echa.europa.eu/documents/10162/4ea3b5ee-141b-63c9-8ffd-1c268dda95e9  
41 https://ec.europa.eu/social/main.jsp?catId=148&intPageId=683&langId=en  
42 See footnote 11.  

9 

 
 
                                                      
The  International  Lead  Association43,  representing  companies  across  the  EU  engaged  in  mining, 
smelting and recycling have long established lead exposure reduction programmes introduced to meet 
the current limit values and to further reduce exposures, where achievable. This reduction of exposure 
over time demonstrates the effectiveness of limit values when combined with industry wide initiatives 
to implement practical risk reduction programmes. 

The three ACSH Interest Groups reached a consensus agreement on the need to revise downwards both 
the existing BLV and OEL ‘to better protect workers’ health taking into account scientific and technical 
developments  since  the  current  limit  values  were  adopted’.  In  their  November  2021  opinion,  they 
advise that oral and inhalation exposure are both relevant routes for the uptake of lead into the human 
body and that blood lead concentrations are the best exposure metric to assess occupational exposure. 
This is because internal lead levels are decisive for the chronic toxicity. Therefore, it is important to use 
the BLV as the primary tool for protecting workers from lead toxicity. The OEL and BLV complement 
each other, and both should be complied with.  

For lead RAC proposed an OEL of  0.004 g /m3 (equivalent to  4 µg /m3)  and a BLV of 15 µg/100ml 
blood  (equivalent  to  150  µg/L  blood)44.  A  BLV  of  15  µg  Pb/100ml  blood  is  considered  health 
protective for male workers, who represent the vast majority of the total workforce exposed to lead, but 
not for the offspring of female workers of child-bearing age. RAC advised the inclusion of a qualitative 
statement  in  the  CMRD  that  exposure  of  women  of  child-bearing  age  to  lead  should  be  avoided  or 
minimised.  There  is  agreement  within the  ACSH that  a  BLV of 15µg/100  ml  is  health  protective  for 
male workers but not for the offspring of female workers of child-bearing age. 

The  three  Interest  Groups  did  not  find  a  consensus  on  what  should  be  the  numerical  levels  of  the 
updated limit values (see Annex 2, table 1). The main reasons for this were the divergent views on how 
best to tackle workers with higher blood levels due to historic exposure, levels of exposure for women 
of  childbearing  age,  and  for  the  OEL,  the  uncertainties  in  the  models  used  to  derive  the  values  and 
technical feasibility together with cost-benefit considerations to achieve these levels. 

The three Interest Groups of the ACSH agree on the importance of health surveillance, which is already 
a  requirement  of  the  CMRD,  for  the  effective  management  of  all  individual  workers  including  those 
who  may  have  been  subject  to  historic  exposure,  or in  the  specific  case  of female  workers  who  may 
wish to start a family. The general requirements for health surveillance (which apply to all substances 
within  the  scope  of  the  Directive)  are  complemented  by  specific  requirements  when  workers  are 
exposed to certain specified levels of lead requiring more detailed medical surveillance when exposure 
exceeds 0.075mg/m3 in air (50% of current OEL) or 40 µg/100ml blood (approx. 60% of current BLV). 
Health/medical  surveillance  is  important  because  lead  is  stored  in  the  bones  for  decades  (half-life  in 
bones45 is 6 to 37 years) and released gradually into the bloodstream.  

The  International  Lead  Association  (ILA)  has  produced  a  number  of  guidance  notes46  for  reducing 
occupational exposure. They support the ILA Voluntary Blood-lead Reduction Programme and provide 
details  on  practical  measures,  e.g.,  regular  health  surveillance  (biomonitoring)  and  practical 
advice/ideas regarding engineering controls. The actions under this voluntary initiative have shown that 
reductions  in  exposure  are  possible  and  are  currently  being  achieved  across  several  sectors. The  ILA 

43 Resources – ILA (ila-lead.org) Position paper on protecting workers from occupational lead exposures (March 
2022) 
44 For coherence with the current limit values in CAD, the metrics of g/m3 for OEL values and µg/100ml blood for 
BLV values are hereafter used throughout this Impact Assessment Report. 
45 The time required for its concentration to decrease by half. 
46 International Lead Association: Guidance Notes. See at: https://ila-lead.org/resources/   

10 

 
 
                                                      
Programme declared aim is to have zero employees exceeding a blood lead content of 20µg/100ml (i.e., 
well below the current BLV). Industry voluntary initiatives reflect technical progress and demonstrate 
that the reduction of workers’ exposure is both technically possible and feasible. 

2.2.3.2 There is no EU limit value for diisocyanates 

The opinion of the ACSH supports the introduction, for the first time, of an EU OEL and STEL for all 
diisocyanates based on the NCO group approach. The limit values should be complemented by a ‘skin’ 
notation  in  order  to  prevent  systemic  health  effects  due  to  absorption from  dermal  contact. The three 
Interest  Groups  agreed  on  the  numerical  values  of  the  OEL  and  STEL  that  should  be  proposed  and 
advised that  a phase-in  approach is required  due  to  technical  measurement  feasibility  and  the time  to 
implement RMMs, in particular in downstream sectors. 

Diisocyanates  do  not  have  a  safe  exposure  level;  only  the  relation  between  exposure  levels  and  the 
associated risk can be described (exposure-risk relationship). Therefore, RAC presented a set of excess 
risks for a range of OELs between 0.025 and 0.67 µg NCO/m3. RAC also stated that the value of STEL 
should be no more than twice that of the OEL, and it should not exceed 6 µg NCO/m3. 

Employers,  in  their  response  to  the  second  stage  social  partner  consultation,  highlighted  the  need  to 
tackle the problem of occupational asthma by preventing peak exposures. They recognise the need to 
take a pragmatic approach to setting the STEL that will significantly reduce peak exposures resulting in 
a major improvement of workers’ health. 

Due to the nature of asthma, specific health surveillance is appropriate in line with Articles 6.3 and 10 
of  the  CAD  to  identify  early  signs  and  symptoms  of  respiratory  sensitisation.  These  arrangements 
should be in accordance with national laws and/or practice, as well as in line with the principles and 
practices of occupational medicine. 

Under  the  CAD  there  are  general  requirements  for  the  training  of  workers,  but  this  is  not  substance 
specific.  Therefore,  due  to  the  need  to  address  the  identified  serious  health  risks  specific  to 
diisocyanates,  a restriction  under  REACH  was  adopted  in  August  202047. The  restriction  requires the 
mandatory training of workers who use diisocyanates, in accordance with specified criteria linked to the 
nature  of  the  work  activity.  This  aims  to  prevent  occupational  asthma  by  reducing  exposure  by  the 
application of good working practices. The training must be in place by August 2023. 

The  introduction  of  limit  values  for  diisocyanates  under  CAD  together  with  the  existing  general 
requirements  of  the  directive  in  conjunction  with  the  restriction  under  REACH  will  provide  a 
comprehensive  complementary  package  of  regulatory  measures  to  ensure  an  overall  effective  risk 
management  approach.  This  package  includes  workplace  risk  assessment,  introduction  and  use  of 
effective risk management measures, worker information, comprehensive training and supervision, and 
appropriate health surveillance. 

2.2.3.3 Differing levels of protection 

Acknowledging the development of the scientific knowledge, some EU countries have already reduced 
their  limit  values  for  lead  to  a  varying  degree  and/or  introduced  limit  values  for  diisocyanates. 
Therefore, workers in the EU are subject to different levels of protection.  

For  lead,  EU countries’  BLVs range  from  20µg/100ml  blood  to  70µg/100ml  blood (the  current  BLV 
under the CMRD). 15 Member States have a BLV lower than the current EU BLV48. Some Member 

47 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020R1149  
48 BG, HR, CZ, DK, FI, FR, DE, HU, IT, LV, NL, PL, SK, SI, SE. 

11 

 
 
                                                      
States have a lower limit for women. This is age dependent or stated as women of childbearing age and 
typically ranges between 20-40 µg/100ml blood. The OEL ranges from 0.05 g/m3 up to 0.15 g/m3 (the 
current OEL under the CMRD).  

For  diisocyanates,  whilst  there  is  no  EU  limit  value,  three  EU  Member  States  have  a  general  OEL49  
and18  have  different  OELs  and  STELS  for  some,  but  not  all,  different  diisocyanates.  As  regards  the 
STEL, 17 Member States have a STEL of which only 5 have a general STEL; the others are for specific 
diisocyanates  substances.  This  makes  presenting  a  general  range  challenging.  However,  where  they 
exist, OELs range from 3 µg NCO/m3 to 500 µg NCO/m3 with a median value of 17.4 µg NCO/m3. For 
the STEL, the range is from 10-82 µg NCO/m3. 

2.2.4  Consequences 

In addition to the above identified issues for workers (ill-health, differing levels of protection), Member 
States are also negatively affected. The resulting illnesses lead to increased social security costs (e.g., 
through higher costs for medical treatment and work incapacity) and missed tax revenues. 

Ineffective  prevention  of  exposure  to  lead  and  diisocyanates  also  entails  negative  consequences  for 
businesses, as companies that do not take appropriate measures may have a competitive advantage over 
those  who  do.  In  the  longer  term,  the  consequences  of  ineffective  prevention  on  businesses  will 
eventually result in higher costs from reduced productivity due to absenteeism and loss of expertise. 

2.3 How will the problem evolve? 

2.3.1  General 

In the absence of EU action, it is estimated that workers exposed to these chemicals will continue to 
face  the  risk  of  occupational  ill-health.  Estimations  of  the  numbers  of  ill-health  cases  and  their 
associated  health  costs  over  a  40-year  period  in  case  no  action  is  taken  are  contained  in  the  baseline 
scenario. 

The general obligations set by the CAD and the CMRD, employers' actions and measures adopted by 
Member States contribute overall to lowering exposure. 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  processes,  or  for  specific  lead  or  diisocyanate  substances,  and  in  the  future  the  numbers  of 
workers in the industries using these chemicals may also change, and technological developments could 
facilitate lower exposure concentrations.  

Future forecasts for both substances are however far from certain due to scarcity of relevant data. For 
that  reason,  assumptions  are  based  on  the  legal  provisions  contained  in  the  CAD  and  the  CMRD, 
including  the  exposure  elimination  and  minimisation  requirements,  but  also  on  other  data  including 
information gathered from the stakeholders. 

2.3.2  Lead 

The  objective  has  been  to  define  a  baseline  scenario  as  close  as  possible  to  the  future  situation. 
However,  it  is  very  challenging  to  anticipate  all  the  developments  over  such  a  long  period.  The  first 

49 HR, IE, LT. 

12 

 
 
                                                      
signs  of  lead  blood  level  reduction  take  a  minimum  of  two  to  three  months  to  become  visible, 
depending on previous levels, effectiveness of measures and biological parameters.  

Data on exposure concentration trends from various sources50 show that blood lead levels have reduced 
drastically  during  the  past  decades  but  appear  to  have  stagnated  in  recent  years.  Continuous  efforts 
within  the  main  lead  producing  and  processing  sectors  indicate  that  further  reductions  are  likely, 
however, these are not reflected in the exposure concentration trend data of the most recent years. In 
view  of  that  stagnation,  exposure  concentrations  are  assumed  to  be  stable  for  the  future  years  in  the 
below calculations.  

Available information does not suggest exposure concentration reduction in other sectors than the main 
lead  producing  and  processing  sectors  for  the  recent  years.  The  key  sectors  and  uses  of  lead  include 
mining of lead ore (8 Member States), refining of ore (18 Member States) and subsequent production 
and use of lead containing products, for example in the construction and battery manufacturing sectors. 
Exposures may also occur in the demolition, renovation, repairing and scrap industry and also during 
recycling of articles due to historical use of lead in paints, electronic equipment and plastics. 

The 'Renovation Wave'51, with a focus on making the buildings more energy-efficient and sustainable, 
will accelerate the renovation works of the EU building stock. The Strategy aims to double the annual 
energy  renovation  rates  by  2030.  This  could  result  in  an  even  greater  number  of  workers  exposed  to 
lead in the near future, for example, during the removal of lead containing paints, plumbing and roofing 
materials. 

Based on market projections for lead batteries, Eurobat expects the numbers of workers in the industry 
to  be  similar  for  the  next  10  years.  From  2030  and  beyond,  there  will  be  significant  changes  to  the 
automotive market in terms of electrification and replacement of the internal combustion engine, as part 
of the European Green Deal goal of reaching carbon neutrality by 2050,  and it is not clear which role 
the lead battery will play in this transition.  Lead batteries are currently used for ancillary purposes in 
electric vehicles and there is no data to indicate that this will change in the near future. In addition, the 
proposal  for  the  new  Batteries  Regulation  sets  targets  for  key  scarce  resources  such  as  lead.  This 
includes a target date of 2030 for 90% material recovery and 2035 for a minimum share of recovered 
lead of 85%. This is a recognition that the use of lead batteries will continue beyond 2035. 

The  same  applies  to  industrial  batteries  where  increased  energy  density  will  be  required  for  many 
storage applications resulting in the need for a more diverse range of available battery technologies52. 

The  external  study  predicts  around  12 000  cases  of  adverse  health  effects  and  1 400  cases  of 
developmental toxicity53 over a period of 40 years and for a workforce of 98 850.  

2.3.3 Diisocyanates 

The  use  of  diisocyanates  is  expected  to  steadily  increase  in  the  future  across  many  sectors. 
Diisocyanates  can  be  used  in  several  ways  within  and  on  buildings.  More  than  220  million  building 

50  Lead  REACH  Consortium  2015-2018  and  2013-2016  surveys,  Voluntary  Risk  Assessment  Report  for  lead 
(2008), as well as national data from Germany (2020), Finland (2013), Romania (2019) and UK (2019). 
51 See footnote 36 
52 https://www.eurobat.org/wp-content/uploads/2021/09/ihs_eurobat_report_lead_lores_final_2.pdf  
53The  study  focussed  on  the  most  relevant  illnesses  per  category  of  adverse  health  effects.  For  non-cancer 
illnesses,  it  estimated  the  cases  of  neuropathy  (neurological  effects),  chronical  kidney  disease  (renal  effects), 
elevated blood pressure (cardiovascular effects), anaemia (haematological effects), as well as male infertility, pre-
eclampsia and developmental toxicity (reproductive effects). For cancer, it estimated the expected number of brain 
cancers. 

13 

 
 
                                                      
units, representing 85% of the EU’s building stock, were built before 2001 and are/will be renovated 
(either  for  maintenance  purposes  or  for  energy  costs  savings)  or  demolished  and  replaced  by  new 
construction. The Renovation Wave Strategy under the European Green Deal (external market driver), 
with  a  focus  on  making  the  buildings  more  energy-efficient  and  sustainable,  will  accelerate  the 
renovation  works  of  the  EU  building  stock.  The  renovation  of  existing  buildings  and  construction  of 
new buildings will result in an increase in the use of modern high efficiency insulation materials54. 

Energy  efficient  insulation  and  an  extensive  range  of  building  techniques  depend  on  polyurethane, 
adhesives,  sealants  and  coatings  that  use  diisocyanates.  There  is  a  risk  of  exposure  related  to  the 
handling of insulation and foam materials during new build and renovation work.  

The  projections  for  renovation  under  the  Renovation  Wave  Strategy  are  for  a  1%  annual  energy 
renovation rate for 2021-2022, an increase to 1.2% per year in 2023-2025 before stabilising at, at least, 
2% per year in 2026-2029. The Commission estimates the potential for an additional 160 000 green jobs 
in the construction sector in the EU by 2030. 

In addition, manufacturers of electric vehicles are increasingly considering replacing heavier  materials 
in cars with polyurethane to offset the weight of batteries. Sophisticated polyurethane coatings are also 
used in many applications including the rotor surfaces of wind turbines. Another example of potential 
growing  demand  is  the  wood  sector  for  use  in  adhesives  due  to  regulatory  pressures  on  existing 
substances used in wood adhesives such as formaldehyde. 

In general, the global demand for diisocyanates is growing55 as they become used in more sectors and as 
their end products are used by a growing European population. However, there is also a continual trend 
to automate industrial processes, particularly those with higher potential for exposure, and therefore the 
number of exposed workers is expected to be static in future years. 

It is estimated that approximately 5 000 cases of asthma and 1 300 cases of irritation will occur each 
year  and  if  no  further  action  is  taken.  This  is  predicted  to  continue  over  the  next  40  years  due  to 
exposure  during  this  period.  The  estimated  number  of  cases  takes  into  consideration  the  anticipated 
effect  of  the  REACH  Restriction,  which  was  introduced  in  2020  and  comes  into  effect  in  2023.  The 
REACH  Restriction  introduces  specific  training  requirements  for  workers  using  diisocyanates.  These 
requirements complement the general training requirements under EU OSH legislation.  

3.  3. WHY SHOULD THE EU ACT? 

3.1 Legal basis 

Article  153  of  the  Treaty  on  the  Functioning  of  the  European  Union  (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.  

54 Exposure to asbestos can occur during the renovation of existing buildings. This occupational risk is addressed 
via a separate initiative to lower the OEL for asbestos fibres in Directive 2009/148/EC.   
55 Statista (2022) available at: https://www.statista.com/statistics/750818/tdi-demand-worldwide/   

14 

 
 
 
                                                      
The  protection  of  workers’  health  against  risks  arising  from  exposure  to  lead  and  diisocyanates  is 
already covered by EU OSH legislation, in particular by the CMRD and the CAD, as well as under the 
REACH Regulation. The change of scope of the CMD resulting from the adoption of the CMRD brings 
lead, a reprotoxic substance, under the CMRD. 

3.2 Subsidiarity: Necessity and added value of EU action 

Scientific  knowledge  about  lead  and  diisocyanates  has  developed  since  the  adoption  of  the  CAD,  in 
1998  (and  the  previous  1982  directive  specific  to  lead).  In  order  to  ensure  that  the  measures  for 
protecting workers from exposure to lead and diisocyanates are as effective as possible, the Directives 
need to be kept up to date with that knowledge. Updating the CAD and the CMRD to take account of 
newer  scientific  evidence  is  an  effective  way  to  ensure  that  preventive  measures  would  be  updated 
accordingly in all Member States.  

Both  substances  are  broadly  used  in  a  wide  range  of  sectors  and  countries.  This  supports  the  added 
value of EU action due to the problem being widespread across the whole EU. 

For lead, the external study identifies 18  Member States that produce refined lead and a more limited 
number of them mining lead. The production rate of lead in the EU is in excess of 10 million tonnes per 
year  used for a  broad  range  of  processes  including  lead  battery,  sheet  and  powder  production,  use in 
articles etc. The voluntary initiatives of the ILA described above, whilst welcome, are non-binding and 
not all employers or sectors are members of organisations to which they apply.  

For  diisocyanates,  they  are  manufactured  in  seven  Member  States  and  used  throughout  the  EU  in  21 
relevant downstream sectors.  

Significant  divergences  between  national  limit  values  distort  competition  in  the  internal  market.  The 
costs of complying with lower national levels are generally higher and entail, therefore, a competitive 
advantage for enterprises operating in markets with no or less stringent national limit values. For lead, 
companies  based  in  Bulgaria,  Czechia,  Denmark,  Latvia  and  Poland  need  to  comply  with  an  OEL  3 
times lower than the maximum OEL set at EU level (0.050 g/m3 vs 0.15 g/m3). As for diisocyanates, in 
the absence of an EU limit value, differences are larger. Where national limit values exist, OELs range 
from 3 µg NCO/m3 to 500 µg NCO/m3. 

The  revision  of  existing,  and  the  introduction  of  new  exposure  limit  values  under  the  CAD  and  the 
CMRD  will  lead  to  a  greater  harmonisation  of  limit  values  across  Europe.  Thus,  while  individual 
Member  States  could  still  introduce  lower  values,  and  further  improve  the  protection  of  workers  as 
aimed by both Directives, the level playing field for enterprises will improve56. Companies willing to 
operate  in  the  different  EU  Member  States  can  further  benefit  from  a  streamlining  of  the  applicable 
limit  values,  potentially  providing  savings  as  common  solutions  can  be  adopted  across  facilities,  as 
opposed to designing site-specific solutions to meet different limit value requirements.  

Furthermore, the revision or introduction of limit values is very complex and requires a high level of 
scientific  expertise.  An  important  advantage  of  the  adoption  of  the  limit  values  at  EU  level  is  that  it 
eliminates the need for Member States to conduct their own scientific analysis with likely substantial 
savings on administrative costs. These resources saved could instead be dedicated to improving further 
the OSH policies in each Member State.  

56 The harmonisation of limit values across the EU would contribute to a level playing field for enterprises. The 
closer the EU OEL gets to zero, the lower the scope for divergences across Member States is.  

15 

 
 
                                                      
Therefore,  for  both  lead  and  diisocyanates,  action  at  EU  level  it  is  both  necessary  and  adds  value. 
Amending the CAD and the CMRD can only be done by action at EU level. 

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

4.1 General objectives 

This initiative contributes to the improvement of health and safety of workers pursuant to Article 153 of 
the  TFEU57  58.  It  aims  at  ensuring  workers  the  right  to  a  high  level  of  protection  of  their  health  and 
safety at work, as laid down in  principle 10 of the European Pillar of Social Rights59, and to prevent 
deaths caused by work-related cancer and other health problems according to the second key objective 
of the EU Strategic framework on health and safety at work 2021-2027.  

For the substances addressed by this analysis this is to be achieved by reducing occupational exposure 
to lead and diisocyanates in the EU.  

4.2 Specific objectives 

The specific objectives are:  

1.  To enhance the effectiveness of the occupational limit values for lead under the CMRD on the 

basis of scientific and technical knowledge;  

2.  To enhance the effectiveness of the CAD by introducing limit values for diisocyanates; 

3.  To achieve a more balanced and effective protection of workers across the EU against lead and 

diisocyanates thereby contributing to a reduction in the burden of occupational ill-health. 

The specific objectives of the initiative contribute to the sustainable development goals on good health 
and  well-being  (3rd  goal)  and  on  decent  work  and  economic  growth  (8th  goal).  A  positive  impact  is 
also  expected  for  the  SDG  on  industry,  innovation  and  infrastructure  (9th  goal)  and  on  responsible 
production and consumption (12th goal). 

4.3 Consistency with other EU policies 

4.3.1  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 Rights60.  

4.3.2  Coherence with the REACH Regulation 

The  REACH  Regulation61,  in  force  since  2007,  establishes  among  others  two  distinct  EU  regulatory 
approaches that are restrictions and authorisations.  

57 OJ C 115, 9.5.2008, p. 114–116 
58 OJ C 326, 26.10.2012, p. 391–407 
59 See footnote 4 
60 OJ C 326, 26.10.2012, p. 391–407 

16 

 
 
 
                                                      
The applicable provisions of REACH restriction of lead and diisocyanates, are as follows (see Annex 
8): 

4.  A number of uses of lead are restricted under REACH. This includes the use of lead in paints 
with some exemptions62  63, the use of lead and its compounds in jewellery and articles which 
are intended to come into contact with the skin, and the use of lead and its mixtures supplied to 
the general public are forbidden64. 

5.  Diisocyanates are restricted under REACH65 and shall not be used or placed on the market as 
substances on their own, as a constituent in other substances or in mixtures for industrial and 
professional uses unless the employer or self-employed ensures that industrial or professional 
user(s) have successfully completed training on the safe use of diisocyanates prior to the use of 
the substance(s) or mixture(s). 

The ACSH, in its opinion, stated that a combination of the REACH restrictions (on worker training) and 
OSH  provisions,  especially  limit  values  and  health  surveillance,  is  the  most  efficient  approach  for 
preventing peak exposure, which is the key event leading to asthma from exposure to diisocyanates. 

Together,  the  EU  OSH  directives  (CMRD  &  CAD)  and  the  REACH  Regulation  are  relevant  for 
workers’ protection from the risks of exposure to lead and diisocyanates. 

4.3.3  Coherence with the Batteries Regulation 

The Commission proposed a new Batteries Regulation66 in December 2020 with the aim to ensure that 
batteries placed on the EU market are sustainable and safe throughout their entire life cycle. This is an 
integral part of the EU Green Deal which aims for greater use of modern non-fossil fuelled vehicles for 
which increased use of lead-containing batteries, including their recycling, is expected. The proposal for 
the new Batteries Regulation sets targets for key scarce resources such as lead. This includes  a target 
date of 2030 for 90% material recovery and 2035 for a minimum share of recovered lead of 85%. This 
recognises  that  the  use  of  lead-acid  batteries  will  continue  beyond  2035.  The  updating  of  the  limit 
values for lead under the CMRD ensures workers in this sector will benefit from a high level of health 
protection and contributes to addressing the risk from hazardous substances which were identified as a 
social risk in the Batteries Regulation proposal. 

4.3.4  Coherence with scientific research 

Lead  and  diisocyanates  were  priority  chemicals  under  the  EU  human  biomonitoring  programme 
(HBM4EU)  funded  by  Horizon  202067.  This  was  a  joint  effort  of  30  countries,  the  European 
Environment  Agency  and  the  European  Commission,  that  ran  from  2017  to  2021.  It  generated 
knowledge to inform the safe management of chemicals and so protect human health. 

61 See footnote 17 
62 https://echa.europa.eu/documents/10162/22dd9386-7fac-4e8d-953a-ef3c71025ad4  
63 https://echa.europa.eu/documents/10162/ffd7653b-98cc-4bcc-9085-616559280314  
64 https://echa.europa.eu/documents/10162/61845f2b-f319-ab2e-24aa-6fc4f8fc150f  
65 https://echa.europa.eu/documents/10162/503ac424-3bcb-137b-9247-09e41eb6dd5a  
66https://ec.europa.eu/environment/pdf/waste/batteries/Proposal_for_a_Regulation_on_batteries_and_waste_batter
ies.pdf  
67 https://www.hbm4eu.eu/about-us  

17 

 
 
                                                                                                                                                                        
4.3.5  Coherence with Europe’s Beating Cancer plan 

The  aim  of  Europe’s  Beating  Cancer  Plan  is  to  tackle  the  entire  disease  pathway68.  It  is  structured 
around four key action areas where the EU can add the most value: (1) prevention; (2) early detection; 
(3)  diagnosis  and  treatment;  and  (4)  quality  of  life  of  cancer  patients  and  survivors.  Whilst  the  main 
adverse health effects resulting from  exposure to lead are on reproductive health, in rare cases it could 
cause cancer, and the reduction in limit values would contribute to preventing this cancer. 

For diisocyanates the adverse health effects do not include cancer and the Europe’s Beating Cancer plan 
is not relevant. 

5.  5. WHAT ARE THE POSSIBLE POLICY OPTIONS? 

5.1 Process for setting binding limit values under the CAD and the CMRD 

A simplified outline of the process for the development of EU limit values, including OELs, STELs and 
BLVs, for priority substances is set out here, with a more detailed description in Annex 7. 

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

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

5.2 Baseline Scenario 

The  baseline  or  "no  policy  change"  option  includes  all  relevant  EU-level  and  national  policies  and 
measures (e.g., the existing national limit values) which are assumed to continue being in force in the 
absence  of  further  EU  action.  It  also  takes  into  account  the  variables  discussed  in  previous  sections, 
such  as  the  current  number  of  workers  exposed  and  its  evolution  over  time,  the  current  and  future 
exposure  levels,  the  current  RMMs,  the  voluntary  industry  initiatives,  the  development  of  new 
technologies  and  any  other  substance-specific  relevant  factors  (e.g.,  the  REACH  restriction  for 
diisocyanates). 

5.2.1  Lead 

EU  wide  OEL  of  0.15  mg/m³  and  a  BLV  of  70  μg  Pb/100  ml  blood,  dated  from  1982  (and  carried 
forward in 1998 in CAD and transferred to the CMRD in 2022) will remain. 

68 https://health.ec.europa.eu/system/files/2022-02/eu_cancer-plan_en_0.pdf  

18 

 
 
 
                                                      
5.2.2  Diisocyanates 

Currently there is no EU level OEL or STEL. Consequently, in the absence of EU levels, divergences in 
protection levels across Member States will continue. 

The REACH restriction requiring specific training of workers using diisocyanates will come into effect 
in  August  2023. The  impact  of  the  REACH  restriction  is  likely  to  be  significant  in  reducing  asthma. 
Following discussions with experts in the steering group for the external study, it was agreed that the 
restriction will result in reducing airborne concentrations of diisocyanates by 50%.  

Regarding changes at industry level, the experts in the steering group for the external study considered 
that, while the growing automatisation of processes should decrease exposure, the growth in the use of 
diisocyanates69  would  compensate  that  effect.  Some  of  those  growing  uses  are  linked  to  the  efforts 
made  in  the  framework  of  the  Green  Deal to  use lighter  materials  to  offset  the  weight  of  batteries  in 
electric  vehicles  and in  the  framework  of  the  Renovation Wave  to  enhance  energy  savings  via  better 
building  insulation.  Based  on  the  available  information,  it  is  not  possible  to  give  a  more  specific 
prediction of future trends.  Therefore, the baseline assumes a continuation of the exposure levels and 
the number of exposed workers.  

The summary of the baseline scenario is presented below.  

 Table 1: Baseline scenario over 40 years 

Types of ill-health caused 

anaemia, 

Lead  
Neuropathy, 
chronic 
kidney  disease,  elevated  blood 
fertility,  pre-
pressure,  male 
eclampsia, developmental toxicity 
(effects on the foetus; IQ loss) 
98 850 

Diisocyanates 
Asthma, irritation 

4 226 583 
Differs per sector 
No change  

Asthma 5 125 cases per year 
Irritation 1 315 cases per year 

No. of exposed workers 
Change in future exposure level  No changes 
No change 
Change in future no. of exposed 
workers 
Current disease  burden  (CDB)  - 
all historic exposures for current 
types  of  exposure  situations 
(estimated)  

1 331 cases per year (combined 
total for all types of ill-health of 
which 1 154 are chronic kidney 
disease) 

Future  disease  burden  (FDB)  - 
for  current  types  of  exposure 
situations (estimated) 
Monetary value FDB  

13 379  (combined  total  for  all 
types of ill-health) 

Asthma 106 910 over 40 years 
Irritation 10 099 over 40 years 

€317  million  –  612.7  million 
Present Value (PV) over 40 years 

€3.9  billion  – 

Asthma: 
€7.2 billion PV over 40 years 
Irritation: 
€7.4  million  – 
€10.4 million PV over 40 years 
(Both 
REACH 
after 
Restriction) 

Based on external study: RPA (2021) 
*Workforce turns over at 5% p.a. 

69  In  2021,  the  global  demand  for  TDI  was  some  2.49  million  tons,  up  from  2.37  million  tons  in  2020  (5% 
increase)  and 
(2022),  available  at: 
in  2016 
https://www.statista.com/statistics/750818/tdi-demand-worldwide/ ). 

than  2  million 

(source  Statista 

from 

tons 

less 

19 

 
 
 
 
 
 
                                                      
5.3 Options discarded at an early stage 

5.3.1  Phasing out the use of lead 

The phasing out of the use of lead was not considered as a realistic policy option. This is because the 
use of this substance remains necessary for a number of critical purposes in a range of sectors including 
construction  activities  and  in  batteries  for  fossil  fuel  and  electric  vehicles.  For  the  latter,  lead  based 
batteries are necessary for non-motive purposes (such as information systems) and for safety to allow 
the vehicles to be brought to a stop in case of an emergency70.  

The  CMRD  does  not  allow  for  the  banning  of  substances.  Instead,  it  places  duties  on  employers  to 
protect workers by aiming to substitute harmful substances by the less harmful and, where this is not 
possible,  to  prevent  exposure.  Where  this  is  not  technically  possible,  employers  have  the  duty  to 
implement risk management measures following a hierarchy of control that requires the use of technical 
measures  (such  as  process  enclosure  or  ventilation)  with  preference  to  the  use  of  personal  protective 
equipment (such as overalls, gloves, respiratory protection).  

In addition, a banning on the future use of lead would not benefit workers who may be exposed due to 
past use of lead. For example, when removing lead containing paint from surfaces prior to re-painting 
with modern lead-free alternatives, or for workers in waste management who may be exposed  to lead 
from discarded items.  

In the case where a ban would be considered necessary, it would be more appropriate to do this as a 
restriction under REACH, for which there are several examples including the banning of lead in paint. 

5.3.2 Guidance documents 

As non-regulatory alternatives, the existing guidance documents or examples of good practice could be 
revised and re-disseminated in cooperation with the European Agency for Safety and Health at Work 
(EU-OSHA) and/or the ACSH and its relevant Working Party. This could also include the launching of 
awareness raising campaigns for employers and workers alike on the prevention of risks arising from 
workers'  exposure  to  lead  and  to  diisocyanates.  In  addition,  industry  could  be  encouraged  to  revise 
guidance material used to support their voluntary initiatives. 

However, guidance documents by themselves would not be considered effective enough in reaching the 
objectives  of 
to 
OELs/STELs/BLVs.  Guidance  on  good  practice  is  of  particular  importance  when  addressing  peak 
exposures to diisocyanates during transient activities such as certain construction tasks. 

initiative.  They  are  complementary  and  provide  an  added  value 

this 

EU-OSHA is currently developing guidance on the use of biomonitoring at the workplace. This will be 
general guidance and not specific to lead, though the general principles will be relevant and helpful. 

5.3.3  Adapted measures for SMEs 

Small  companies,  accounting  for  around  99%  of  companies  working  with  lead  and  diisocyanates, 
should  not  be  exempted  from  the  scope  of  the  initiative.  Their  exclusion  would  mean  that  the  vast 
majority  of  European  workers  at  risk  of  exposure  to  these  groups  of  substances  would  not  be 
sufficiently protected by health and safety at work legislation, with a clear distortion and inequality in 

70  Consortium  for  Battery  Innovation  |  »  How  lead  batteries  make  EVs  safer  https://batteryinnovation.org/how-
lead-batteries-make-evs-safer/  

20 

 
 
 
                                                      
the application of the EU legislative framework and with a risk of compromising the underlying social 
policy objectives and fundamental rights.  

Another  option  to  assist  SMEs  is  to  extend  the  implementation  time  the  limit  value.  This  has  been 
considered  for  diisocyanates  to  take  account  of  the  need  to  adapt  industrial  processes.  Based  on 
discussions with stakeholders, including the ACSH, a similar approach was not agreed for lead. 

5.4 Policy options 

In  addition  to  the  baseline  scenario,  options  for  different  limit  values  -OELs,  STELs  and  BLVs-,  are 
presented  below.  They  take  into  account  the  scientific  assessments  done  by  the  RAC  of  ECHA,  the 
adopted  opinions  from  the  ACSH  and  the  limit  values  in  place  in  the  different  Member  States  (see 
Annex 5).  

The external study provided a comparison of the costs and benefits for a range of potential OELs and 
BLVs. The ranges start at the values proposed by RAC. 

Throughout the analysis of benefits and costs, the reference levels in tables 2 and 3 have been chosen as 
the  options  of  the  assessment.  The  external  study  considered  a  number  of  additional  intermediate 
reference  levels  and  assessed  their  corresponding  impacts.  To  streamline  the  presentation  of  the 
analysis, they are not retained in this report. 

5.4.1  Lead 

Table 2 : BLV options for lead 

Options 
Option 1 (baseline) 

Level, µg/100 ml 
70 

Option 2 

Option 3 

Option 4 

20 

15 

4.5 

Reason for inclusion 

for 

target 

Existing EU level.  
Lowest  national  BLV  in  EU 
Member  States 
all 
(Denmark). 
workers 
of 
Voluntary 
International 
Lead 
Association. 
BLV at the level proposed by 
RAC. 
Biological  guidance  value 
background 
related 
to 
the  general 
exposure  of 
population. 
to 
Applies 
women  of  childbearing  age 
(under 50 years of age).  

The detailed analysis of the impacts concerns lowering the BLV from 70 to 20, 15 and 4.5 µg/100ml. 
Setting  the  BLV  at  0  µg/100ml  is  not  a  realistic  option  due  to  background  exposure  of  the  general 
population from non-occupational sources of exposure such as dietary intake. 

In  addition  to  lowering  the  BLV,  it  is  necessary  to  lower  the  OEL.  Since  blood  lead  levels  are 
recognised as the main exposure metric in assessing occupational exposures, most companies focus on 
blood levels management and found it challenging to provide data on airborne levels management. As 
stated  in  the  ACSH  opinion,  the  relationship  between  the  levels  of  lead  in  air  and  blood  depends  on 

21 

 
 
 
various  factors  within  an  occupational  setting  and  an  unambiguous  correlation  between  these  two 
metrics is not apparent.  

Therefore, it is not possible to identify OEL options and to independently assess their impacts with any 
degree  of  certainty.  However,  the  RMMs  used  to  reduce  blood  levels  will  reduce  airborne  ones  and, 
considering the views of key stakeholders in the ACSH opinion, a numerical value for the revised OEL 
is presented as a preferred option to complement the BLV. In its opinion, the three Interest Groups of 
the ACSH did not reach a consensus on what the numerical levels of the updated limit values should be. 
Whilst  the  Governments’  and  Employers’  Interest  Groups  supported  a  BLV  of  15µg/100  ml,  the 
Workers’ Interest Group favoured a limit value of 4.5µg/100 ml (for more details, see Annex 2).  The 
preferred  option  takes  into  account  the  assessment  of  the  impacts  of  the  options  assessed  for  the 
revision  of  the  BLV.  Whilst  imprecise,  this  is  considered  to  be  an  acceptable  way  forward  by  the 
ACSH.  

5.4.2  Diisocyanates 

Table 3 : OEL options for diisocyanates 

Options 
Option 1 (baseline) 

Level, µg NCO/m3 
- 

Option 2 

Option 3 

Option 4 

10 

6 

3 

Reason for inclusion 

No existing EU level  
Agreed  by  study  steering 
group members 
 Agreed  by  study  steering 
group members 

This  is  numerically  half  the 
STEL 
maximum 
recommended  by  RAC  who 
also  recommended  the  STEL 
is at most two times the OEL 

The  external  study  assessed  a  broader  range  of  options,  including  options  below  3μg  NCO/m3.  This 
information  on  lower  options  was  available  to  the  ACSH  when  they  agreed  on  the  limit  values 
recommended in their opinion. Since the ACSH adopted its opinion by consensus supporting an OEL of 
6  μg  NCO/m3,  the  options  retained  for  the  analysis  were  selected  to  represent  a  realistic  range  of 
possible limit values at, above and below the value recommended by the ACSH.  

An  OEL  defined  as  an  8-hour  TWA  exposure  based  on  the  ‘NCO  group’  can  be  obtained  from  the 
Exposure Risk Relationship (ERR) for hyperresponsiveness or diisocyanate asthma as derived below, 
based on excess risk over a working life period. 

A 15-minutes STEL value is required since peak exposures are important and drive the onset of asthma. 
However,  measuring  peaks  in  epidemiological  studies  is  not  practically  possible  and  for  this  reason, 
RAC focussed on the OEL whilst concluding on the need for a STEL that should be determined using a 
multiplication factor of no more than two times the OEL.  Based on its scientific evaluation including 
the exposure risk relationship, RAC recommended that the STEL should not exceed 6 µg/m3 NCO and 
that it should be no more than two times the OEL. This takes into account availability of scientific data, 
which is not fully conclusive and is subject to expert scientific opinion based on associated excess risk 
levels with different exposures. It is consistent with accepted practice whereby there is a factor between 
the  OEL  and  the  STEL.  In  this  specific  case,  RAC  considered  a  factor  of  2  to  be  appropriate.  The 
details of this approach are presented in the RAC Opinion.  This is  taken into account in the assessed 
policy options. 

22 

 
 
 
RAC states that any limit value will be associated with a residual risk since it is not possible to identify 
a safe threshold of exposure at which there is no risk. Based on the ERR, all of the assessed options are 
associated  with  an  excess  risk  of  developing  occupational  asthma  over  a  working  life.  RAC  further 
advised that the lower the exposure, the lower the risk for developing asthma. 

Whilst  this  analysis  focusses  on  the  OEL,  it  should  be  noted  that  the  control  measures  necessary  to 
ensure compliance with the OEL will also contribute to controlling short term exposures. An explicit 
separate  assessment  of  STEL  levels  is  not  possible  due  to  a  lack  of  appropriate  data  on  short-term 
exposures.  Since  the  lack  of  scientific  data  limits  the  possibilities  for  an  assessment  of  the  health 
benefits  of  the  different  STEL  options  for  diisocyanates,  the  projections  related  to  costs  are  also 
impacted.  The  likely  underestimation  of  the  costs  and  benefits  does  therefore  not  allow  for  a  purely 
quantitative comparison. This is developed further below in section 6.1. 

Moreover,  RAC  considered  that  notations  for  skin  sensitisation,  respiratory  sensitisation,  ‘skin’  were 
warranted.  The  notations  indicate  that  in  addition  to  the  need  to  control  inhalation  exposure,  it  is 
important to prevent dermal exposure as the substance can be absorbed through the skin and contribute 
to  overall  exposure  and  elicitation  of  asthma.  This  can  be  achieved,  for  example,  by  the  wearing  of 
gloves and coveralls. 

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

6.1 Analytical methodology 

The revision of the limit values for lead and the introduction of an OEL and a STEL for diisocyanates is 
expected to result in a reduction in the occupational exposure to  both these hazardous chemicals. 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 (the “baseline scenario”).  

For  a  given  reduction in  exposure levels,  the expected  decrease  in  the incidence  of  ill-health over  40 
years  was  calculated.  This  required  estimating  the  risks  of  adverse  health  effects,  derived  from  the 
existing toxicological and epidemiological literature, as well as information about the  current level of 
worker  exposure  (number  of  workers  exposed,  level,  duration  and  frequency  of  exposure).  The 
calculations of ill-health cases and the cost-related calculations are based on a 40-year reference period, 
in  order  to  take  into  account  the  total  risk  over  the  working  life.  This  allows  to  present  a  long-term 
view, instead of considering only the risks that might manifest at the early stages of exposure. 

The  health  benefits  of  the  revised  OEL/STEL/BLV  are  calculated  in  terms  of  the  costs  of  ill-health 
avoided. They have been expressed in monetary terms by applying standard valuation methods, in line 
with the Better Regulation Toolbox guidance. Method 1 is the application of a single willingness to pay 
(WTP) value to each case and Method 2 is the use of disability adjusted life years (DALYs) and their 
monetisation. Both estimates monetise the same number of avoided cases and use identical methods for 
the  monetisation  of  direct  (healthcare,  informal  care,  disruption  for  employers)  and  indirect 

23 

 
 
 
(productivity/lost  earnings71)  impacts  but  use  different  approaches  to  assign  monetary  values  to 
intangible effects (reduced quality of life, pain and suffering, etc.).  

The estimate of the costs was made based on a literature research and data obtained from stakeholders 
and  take  into  account  the  following  factors:  the  RMMs  72  needed  to  comply  with  the  proposed  limit 
values,  the  costs  of  these  RMMs  for  each  company,  the  life  span  of  the  RMMs  and  the  number  of 
companies.  

The  benefits  and  costs  of  possible  limit  values  are  measured  against  the  baseline,  meaning  that  only 
marginal  costs  and  marginal  benefits  are  taken  into  account  (i.e.,  additional  costs  imposed  by  the 
different OEL scenarios on top of those that businesses would already have to bear under the baseline in 
order to comply with their existing obligations). 

The  calculations  in  the  report  are  subject  to  certain  methodological  limitations.  Regarding  lead, 
exposure  concentrations,  the  number  of  workers  and  their  turnover  are  key  determinants  of  the  costs 
and  benefits.  A  sensitivity  analysis  was  performed  to  simulate  a  higher  and  lower  value  for  each  of 
those three factors. In general, costs-benefit ratios did not change significantly for the two first. Only in 
the  case  of  worker  turnover  (as  it  affects  only  the  calculation  of  the  benefits)  did  that  ratio  improve 
(higher turnover) or decrease (lower turnover) more significantly.  

For  diisocyanates,  the  main  methodological  limitation  impacting  the  robustness  of  projections  is  the 
lack of scientific data to assess the health benefits of the different options. Whilst peak exposures are 
particularly important in the development of occupational asthma73, related ill-health cases could not be 
modelled  due  to  a  lack  of  data  on  short-term  exposures  (see  section  5.4.2).  This  results  in  an 
underestimation of the costs and a significant underestimation of the benefits (asthma accounts for more 
than  90%  of  the  future  disease  burden)  and  the  impossibility  to  calculate  the  impact  of  the  different 
STEL  options  in  terms  of  ill-health  cases  avoided.  Consequently,  it  does  not  allow  for  a  purely 
quantitative  comparison  of  the  options.  Another  source  of  uncertainty  is  the  assumed  impact  of  the 
REACH  restriction.  However,  due  to  the  difficulties  regarding  the  calculation  of  the  benefits,  the 
sensitivity analysis performed is less straightforward than in the case of lead.   

 More information about the analytical methodology is available in Annex 4.  

6.2 Social impacts 

6.2.1  Health impacts for workers and families 

Lead 

Table  4  presents  the  number  of  avoided  cases  of  ill-health  as  well  as  monetised  benefits.  For  the 
endpoint developmental toxicity, the effects are in the form of IQ loss of newborns.  

71  This  is  not  the  case  where  lost  earnings  are  already  taken  into  account  in  the  willingness  to  pay  estimate  in 
published literature. 
72 E.g., engineering and ventilation controls, cleaning, personal hygiene, personal protective equipment. 
73  The  RAC  opinion  states  that  there  are  indicators  that  peak  exposures  are  important  for  the  risk  of  asthma 
development. However, measuring peaks in human epidemiological studies is not practically possible because of 
measurement difficulties. 

24 

 
 
 
                                                      
Table 4:  Number of avoided cases of ill-health by endpoint over 40 years for each BLV policy 
option (compared to baseline) 

Endpoint 

Option 2 
(20 µg/100ml) 

Option 3 
(15 µg/100ml) 

Option 4 
(4.5 µg/100ml) 

6 
290 
1 645 
5 085 
2 365 
387 
23 
540 

4 
179 
1 381 
4 273 
1 969 
310 
16 
370 

Central nervous system cancer 
Neuropathy 
Anaemia 
Chronic kidney disease stage 1 
Elevated blood pressure 
Male fertility 
Pre-eclampsia 
Developmental 
IQ loss) 
Total  number  of  avoided  ill 
health cases 
Health  benefits  of  avoided  ill 
health cases due to revised BLV 
in  monetary 
terms  over  40 
years*. 
* Standard valuation method. Lower value Method 1, higher value Method 2 

€130 million - €200 
million 

€160 million - €250 
million 

toxicity  (total 

10 341 

8 502 

6 
290 
2 009 
6 208 
2 912 
491 
38 
1,141 

13 095 

€200 million - €310 
million 

Source: RPA, 2021. External study 

All options substantially improve the protection of workers, with option 4 having the most substantial 
impact on number of avoided ill health cases. The health benefits in monetary terms are presented as a 
range as they depend on the methodology used. The benefits would be slightly higher under options 3 
and 4 but significant progress would be made under each option.  

Gender  is  an  important  factor.  Even  though  the  share  of  the  female  workforce  is  relatively  small 
(around 3%),  lead can  affect the  developing foetus  in  pregnant  women.  RAC  mentions  in  its  opinion 
that option 3 (and option 2 by analogy) does not protect from developmental toxicity. Consequently, it 
suggests to avoid any exposure of women of childbearing age. Against this background, option 4 would 
offer a better protection to these women by preventing almost all pre-eclampsia cases and about 80% of 
developmental toxicity cases.  

Diisocyanates 

Table 5 presents the number of avoided ill-health cases under each option. However, and as highlighted 
in section 6.1, the ill-health cases associated with peak exposures could not be calculated due to a lack 
of  scientific  data.  This  leads  to  a  significant  underestimation  of  the  ill-health  cases,  especially  since 
peak  exposures  are  particularly  important  in  the  development  of  occupational  asthma,  the  main 
endpoint.  

25 

 
 
 
 
 
 
 
 
Table 5:    Number  of  avoided cases  of ill-health  by  endpoint  over  40  years  for  each OEL  policy 
option (compared to baseline) 

Endpoint 

Asthma 
Irritation 

Option 2  
(10 µg NCO/m3) 
0 
0 

Option 3  
(6 µg NCO/m3) 
0 
0 

Option 4  
(3 µg NCO/m3) 
50 
259 

Source: Study team 

Reducing cases of asthma and irritation would, in theory, require an OEL set at 3 µg NCO/m3 (option 4) 
or lower74. Monetised benefits of option 4 are estimated between EUR 0.8 and EUR 2.2 million. As the 
calculations could not take into account ill-health cases associated to peak exposures,  options 2 and 3 
would, according to the model, have no positive impacts on the number of ill-health cases against the 
baseline  scenario.  However,  although  not  possible  to  calculate, it  can  be  anticipated  that  by  reducing 
average and peak exposures, benefits would materialise at options 2,  3 and 4 levels. Therefore, we can 
conclude  that  options  2,  3  and  4  will  lead  to  a  more  significant  improvement  of  the  protection  of 
workers than what it is reflected in the table. 

6.2.2 

Impacts on employment 

Lead  

The negative consequences on employment are only expected under option 4 as 29 companies (out of 
which 25 are small or medium-sized enterprises) would discontinue their activities75, in particular in the 
sectors  of  foundries  and  demolition,  repairing  and  scrap  industry.  About  1 800  workers76  in  the  EU 
would lose their job, which would represent an estimated cost of EUR 150 million for workers and their 
families. It cannot be excluded that some of these workers could find work in companies offering lead-
free alternative solutions in the same sectors. However, it was not possible to quantify these possible 
transfers due to a lack of data.  

No discontinuation is expected under options 2 and 3. More information on the companies which would 
discontinue under option 4 is provided in section 6.3.2. 

Diisocyanates 

There are no negative impacts on employment expected under options 2 and 3. Under option 4, about 
50 companies (almost all small companies) operating in textiles and apparel sectors would close down 
due to excessive impacts on their activities.  Around 100 workers in the EU are expected to lose their 
jobs, which would represent an estimated cost of EUR 8.5 million for workers and their families.  

74 Based on the STEL being numerically twice the level of the OEL, this would result in a STEL of 6 µg NCO/m3 
(value recommended by RAC). 
75 A company is expected to discontinue when the cost of the risk management measures is higher than the cost of 
discontinuing. 
76 300 workers in secondary lead production, 840 in lead battery production, 92 in production of articles 
of lead metal, 400 in foundries, 105 in ceramic ware production and enamelling, 13 in work with lead 
metal and 27 in demolition, repairing and scrap industry.  

26 

 
 
 
 
 
                                                      
6.3 Economic impacts 

6.3.1 

Impact on businesses, including SMEs 

Lead 

The  direct  costs  for  businesses  (table  6)  depend  exclusively  on  the  costs  of  the  necessary  RMMs  to 
comply with a stricter EU limit value for lead (‘compliance costs’). Since companies already have to 
demonstrate  compliance  with  the  existing  EU  limit  values  for  lead  and  perform  health  surveillance 
according to the requirements in the CAD, it is not expected that they will face additional monitoring or 
administrative costs. 

The additional compliance costs (compared to the baseline) are increasing with the stricter values. They 
are estimated at EUR 348 million (option 2), EUR 745 million (option 3) and EUR 6.3 billion (option 
4). About 22 500 companies (99% of them small or medium-sized enterprises) would have to bear those 
additional costs under all options. The costs per company (over 40 years) would vary on average from 
EUR 15 000 to EUR 300 000 depending on the policy option. Under options 2 and 3, the compliance 
costs would represent less than 1% of the annual turnover. Under option 4, the share would be between 
1%  and  3%  and  would  affect  in  particular  small  and  to  a  lesser  extent  medium-sized  enterprises 
operating in some sectors77. 

The companies will also have benefits related to improved labour productivity, lower costs of sick leave 
and  other  administrative  and  legal  costs  (e.g.,  linked  to  the  replacement  of  employees).  They  are 
expected to vary from EUR 5 to EUR 6 million.    

All the Member States, with exception of Denmark78, would have to lower their existing limit values 
under any of the options. Therefore, almost all the companies in the EU would be affected in a similar 
way. A wide variety of sectors are particularly represented in France, Germany, Italy, Poland and Spain, 
in which the existing limit value is higher than option 2. Therefore, these Member States are expected to 
be more affected under each policy option.   

More details per sectors and Member States are provided in section 6.3.2. 

Table 6: costs and benefits for businesses (in € million, over 40 years) 

Option 2 
(20 µg/100ml) 

Option 3 
(15 µg/100ml) 

Option 4 
(4.5 µg/100ml) 

Costs 
Compliance costs 
Monitoring costs 
Administrative costs 
Benefits  
Avoided costs 

€350 
€0 
€0 

€4 

€750 
€0 
€0 

€5 

€6,300 
€0 
€0 

€6 

77  Secondary  lead  production  (including  lead  battery  recycling),  production  of  articles  of  lead  metal,  foundries, 
production of lead compounds and lead frits and ceramic ware production and enamelling. 
78 Denmark has a national limit value of 20 µg/100ml. 

27 

 
 
 
 
 
 
                                                      
Diisocyanates 

Compliance costs 

Under  option  2,  companies  would  not  face  additional  compliance  costs  compared  to  the  baseline 
scenario. The measures currently in place should be sufficient to keep the workers’ exposure under this 
limit value.  

In  the  case  of  options  3  and  4,  however,  there  will  be  additional  compliance  costs  (table  7)  due  to 
additional  investment  in  risk  management  measures  (RMMs).  This  would  entail  investing  in  local 
exhaust  ventilation  systems  (requiring  high  one-off  and  low  recurrent  costs).  On  the  other  side,  both 
these  options  would  also  lead  to  savings,  as  the  new  ventilation  systems  will  reduce  the  need  to  use 
respiratory protective equipment (characterised by low one-off and high recurrent costs).  

Under option 3, only companies operating in manufacture of textile  and wearing apparel sectors (less 
than  1%  of  the  total  number  of companies  with  exposed  workers)  would  need  to  invest in  additional 
RMMs.  The  costs  will  be  approximatively  EUR 10.5  million  over  40  years  (EUR 3.3  million 
[manufacture of textile] and EUR 7.2 million [wearing apparel]). This net cost over 40 years takes into 
account  EUR 4.4  million  savings  due  to  a  reduced  use  of  respiratory  protective equipment. This  also 
means that companies in those two sectors would have to bear upfront EUR 15 million, which would 
represent approximatively EUR 1 425 per company. 

Under option 4, companies operating in several sectors would have to invest about EUR 830 million in 
new RMMs over 40 years. In the decreasing order of total costs, the sectors are maintenance and repair 
of motor vehicles, manufacture of wearing apparel, manufacture of textile, manufacture of chemicals, 
and repair and installation of machinery and equipment. However, the costs per company are expected 
to be particularly high for companies operating in textile and wearing apparel sectors (EUR 8 200 and 
EUR 4 300  respectively)  compared  to  the  others  (between  EUR 0  and  EUR 3 100).  These  costs 
represent  only  0.05%  of  companies’  turnover,  but  the  necessary  investments  would  be  made  almost 
entirely  from  day  1.  Overall,  the  companies  most  impacted  would  be  small  and  medium-sized 
enterprises, which usually have less capital for investment.  

Monitoring costs 

65%  of  companies  operate  in  19  Member  States  with  existing  OELs  and  STELs  for  at  least  one 
diisocyanate (in particular MDI or TDI). However, it is expected that those with low exposure levels 
usually do not measure it as it is not strictly required in certain Member States. The remaining 35% of 
companies are assumed not to carry out any measurement at the moment since they operate in Member 
States with no limit values.  

The  monitoring  of  the  OEL  and  STEL  is  assumed  to  be  carried  out  at  the  same  time.  Therefore,  the 
costs of administration, planning, execution and reporting are shared. Only costs related to sample/filter 
and analysis are specific to OEL or STEL. 

Under  option  2,  it  is  assumed  that  50%  of  the  companies  operating  in  a  Member  State  with  no  limit 
value79  will  start  monitoring  workers’  exposure.  This  means  around  435 000  (431 500  small, 
2 950 medium and 620 large) companies that would in total spend EUR 4.6 billion on monitoring over 
40 years. The costs per company according to their size  over 40 years would be EUR 10 351 (small), 

79 Eight Member States have neither an OEL nor a STEL: CY, CZ, EL, LU, MT, NL, PT, SK. 

28 

 
 
                                                      
EUR 32 922  (medium)  and  EUR 182 041  (large).  For  companies  in  Member  States  with  an  existing 
limit value for one or several diisocyanates, no additional costs are expected. 

Under options 3 and 4, 75% of the companies in Member States without a limit value are assumed to 
start monitoring workers’ exposure. The number of concerned companies and the monitoring costs will 
therefore be the same under both options.  In total,  about 1 million  companies (1 million small, 7 100 
medium  and  1 500  large  companies)  would  dedicate  EUR 11  billion  over  40  years  for  monitoring 
workers’ exposure, which represents EUR 11 265 per company over 40 years.  

Administrative costs 

The cost of planning, executing and reporting the sampling and analysis of monitoring is carried out by 
an external specialised company and considered therefore as compliance cost. However, although this 
task is externalised, some staff still have to manage the monitoring carried out by the external company. 
The  spending  related  to  this  management  is  an  administrative  cost.  Since  larger  companies  have  to 
monitor the exposure of more workers than SMEs, it is assumed that more time and/or resources have 
to be mobilised. Based on the estimates, large companies would spend  EUR 22 230 over 40 years for 
managing  the  externalised  monitoring  while  small  and  medium-sized  companies  would  dedicate 
EUR 2 223 and EUR 11 115 respectively, over the same reference period. 

Benefits  

Establishing an EU-wide OEL and STEL for diisocyanates would also bring benefits to companies in 
the form of cost savings, depending on their values. A decrease in the number of ill-health cases would 
lead to less sick leave, increased labour productivity, reduced administrative and legal costs (e.g., when 
finding replacements for sick staff). Under options 2 and 3, no monetised benefit could be estimated as 
the  avoided ill-health cases could  not be quantified. Regarding option 4, only  businesses  operating in 
the textile and apparel sectors would save about EUR 0.4 million over 40 years). 

Total costs and benefits 

Most  of  the  costs  for  companies  derive  from  the  obligations  to  monitor  the  workers’  exposure, 
representing about 80% of the total costs for each option. Under option 2, businesses would spend more 
than EUR 5.5 billion over 40 years. Under options 3 and 4 they would have to spend EUR 13.4 billion 
and  EUR 14.2  billion  respectively.  Since  the  monitoring  and  administrative  costs  are  equivalent  for 
options  3  and  4  (EUR 13.4  million),  their  difference  lies  in  the  risk  management  measures’  costs 
(EUR 10  and  EUR 830  million  respectively).  Although  businesses  would  save  some  expenses  under 
option 4, these are too limited to be considered as mitigating the costs. 

On  average,  a  company  would  spend  EUR 2 300  under  option  2,  EUR 5 550  under  option  3  and 
EUR 5 887 under option 4. Since most of these costs are related to monitoring tasks, they are spread 
over  the  40-year  reference  period.  Therefore,  companies  would  bear  annual  costs  ranging  from 
EUR 57.5 to EUR 150 depending on the option retained. 

While  the  average  yearly  cost  per  company  is  limited,  companies  operating  in  textiles  and  apparel 
sectors would have to spend between EUR 4 000 and EUR 8 000 in RMMs from day 1 to comply with 
an OEL at the level of option 4. Since more than 97% of those companies are small enterprises, some of 
them might face difficulties to bear those incremental costs. It is estimated that about 50 SMEs would 
cease their activities under option 4. No plant closures are expected under options 2 and 3. 

More details per sectors and Member States are provided in section 6.3.2. 

29 

 
 
Table 7: costs and benefits for businesses (in € million, over 40 years) 

Option 2 
10 µg NCO/m3 

Option 3 
6 µg NCO/m3 

Option 4 
3 µg NCO/m3 

Costs 
Compliance costs 
Monitoring costs 
Administrative costs 
Benefits  
Avoided costs 
Source: RPA, 2021, External Study  

€0 
€4,600 
€1,000 

€0 

€10 
€11,000 
€2,400 

€0 

€830 
€11,000 
€2,400 

€0.4 

6.3.2 

Impact on the single market 

Lead 

All  the  companies  should  be  financially  robust  enough  to  comply  with  an  EU  BLV  at  the  level  of 
options 2 or 3, but some could face more difficulties under option 4. The discontinuation of activities by 
companies is calculated based on the cost of the RMMs in relation to the turnover and profit margin for 
an individual enterprise. The discontinuation cost is taken as the loss of profit taken over 20 years and 
the average profit is assumed to be 10% of turnover. More details on the methodology used to estimate 
discontinuation can be found in Annex 4, section 2.1.5 on the methodology. 

Amongst the options analysed, discontinuations would only occur with a BLV of 4.5 µg/100ml. Indeed, 
the  estimates  show  that  29  companies  (of  which  25  are  small  or  medium-sized  enterprises)  in  eight 
sectors80  would  discontinue  their  activities  if  the  limit  value  is  brought  down  to  4.5  µg/100ml.  The 
ceramic ware production and enamelling sector would be particularly affected. It is assumed that 11.6% 
of enterprises with exposed workers in those two sectors would exit the market under option 4. 75% of 
the companies in those two sectors are based in Spain and Italy. Furthermore, between 5% and 8% of 
the companies with exposed workers in the following sectors would also exit the market under option 4: 
secondary  lead  production  (including  lead  battery  recycling),  lead  battery  production,  production  of 
articles of lead metal and foundries. While we do not have figures about foundries, between 43% and 
60% of the companies operating in the first three sectors are based in Germany, Italy or Poland.  The 
consequences  on  the  employment  of  enterprise  closures  are  discussed  in  section  6.2.2.  The  costs  to 
comply with option 4 are significant and would lead companies in some sectors to dedicate more than 
1% of their turnover to RMMs. About 75% of these compliance costs are one-off costs, which means 
that companies wishing to enter the market would face a significant increase in capital costs to invest 
when setting up the business. Consequently, it is expected that revising the limit value for lead at the 
level  of  option  4  would  increase  market  entry  barriers,  in  particular  for  the  sectors  referred  to  in 
footnote 74. On the contrary, the impact of reducing the limit value to the level of option 2 or 3 would 
not be significant.  

The compliance costs will also have a negative impact on companies operating in sectors where lead-
free  alternative  products  are  available  (e.g.,  ceramic  frit,  alloys,  crystalline  glass).  Although  it  is  not 
possible to quantify this impact, those enterprises competing with lead-free products will be less cost 
competitive, particularly under option 4, since they would bear high compliance costs. 

80 Secondary lead production (including lead battery recycling), lead battery production, production of articles of 
lead  metal,  foundries,  ceramic  ware  production  and  enamelling,  work  with  lead  metal,  shooting  ranges,  and 
demolition, repairing and scrap industry. 

30 

 
 
 
                                                      
Revising  downward  the  existing  limit  value for lead would  increase  harmonisation  across  the  EU,  as 
Member States can only adopt limit values equal or lower than the EU one. This would have a positive 
impact on the level playing field for companies across the internal market. Under option 3 or option 4 
almost  all  Member  States  would  have  the  same  limit  value.81  Medium  and  large  companies  with 
facilities across the EU could in particular benefit from the regulatory simplification arising from this 
increased harmonisation. 

Diisocyanates 

Under all policy options, the total costs over 40 years for companies would not represent a significant 
share  of  their  total  turnover.  Only  small  companies  active  in  the  repairs,  apparel,  vehicle  repair, 
specialised  construction  and  textile  sectors  would  have  to  dedicate  between  0.1%  and  0.2%  of  their 
turnover to comply with an OEL (and its associated STEL) set at the level of option 4, which remains 
relatively bearable. Therefore, the impact on companies using diisocyanates compared to the others not 
using them in a same sector should be very limited.  

About 50 companies (mainly small enterprises) active in textiles and apparel sectors would close down 
under option 4. They represent only 0.03% of the market for the two sectors (0.5%  when considering 
only  companies  with  workers  exposed  to  diisocyanates)  and  therefore  no  significant  impact  on 
competition within the single market is expected. The other two options would not have any impact on 
competition.  

Although some sectors (textiles and apparel) could be characterised by higher costs under option 4, they 
are not as significant as to impact new entrants compared to existing firms. Since costs for companies 
are lower under options 2 and 3, the same observation applies.  

The  introduction  of  both  an  OEL  and  a  STEL  for  diisocyanates  will  improve  the  functioning  of  the 
single  market  by  reducing  disparities  across Member States.  To date,  eight  Member  States  in the  EU 
have no OELs and STELs for any kind of diisocyanates. Most of the remaining 19 Member States have 
OEL  or  STELs  for  a  few  diisocyanates  only,  which  are  higher  than  those  explored  in  this  impact 
assessment. Therefore, setting an OEL and a STEL for all diisocyanates and a lower level than what it 
is  currently  in  place  in  a  majority  of  Member  States  will  entail  a  more  harmonised  legal  framework 
within the EU. In particular, companies operating or wishing to operate in more than one Member State 
would benefit from a less fragmented internal market. They will save on both research costs and design 
costs  through  facilitating  the  adoption  of  common  solutions  to  reduce  exposure  across  plants  in 
different locations.  

6.3.3 

Indirect economic impacts 

Lead 

This  section  relies  on  a  qualitative  assessment  due  to  a  lack  of  data.  Research  and  development 
(R&D) are key activities in an industry’s capacity to develop new products and produce existing ones 
more efficiently and sustainably, in a way that protects the safety of workers. The ability to engage in 
R&D activities is likely to be affected by the availability of financial resources to invest in R&D; the 
availability  of  human  resources  to  conduct  R&D  activities;  and  regulatory  environment  conducive  to 
investing  in  R&D  activities.  Compliance  costs,  particularly  under  option  4,  will  have  an  impact  on 
enterprises’ capacity to innovate, as the research and innovation budget is likely to be partly diverted to 
invest in RMMs. 

81 Unless they decide to set a more stringent limit value. 

31 

 
 
                                                      
Consumers  may  be  impacted  if  higher  costs  for  enterprises  increase  their  prices.  Since  the  costs  for 
businesses under options 2 and 3 are estimated not to be significant, the impact on consumers should be 
very limited. Under option 4, companies could be tempted to pass on a part of the compliance costs to 
the  consumers.  However,  most  of  the  sectors  are  characterised  by  a  high  degree  of  competition; 
therefore,  this  is  unlikely  to  happen.  For  the  sectors  of  primary  lead  production,  production  of  lead 
compounds  and  copper  production,  the  costs  will  likely  be  passed  on  to  consumers,  owing  to  a 
moderate to high market concentration.  

The impacts on international competitiveness of EU companies would significantly vary depending 
on  the  option.  The  impacts  on  international  competitiveness  of  EU  companies  under  options  2  and  3 
would be limited and moderate. A substantial number of EU sectors and enterprises pursue a voluntary 
limit value of 20 µg/100ml (same as option 2).  .Only three non-EU countries have a binding  BLV in 
place  for  lead,  which  range  between  the  existing  EU  BLV  and  the  proposed  revised  EU  BLV  (see 
Annex 5), most of them have an OEL (according to the assessment, it would correspond to a BLV of 30 
µg/100ml).  The  impacts  under  option  4  could  be  substantial  as  the  companies  operating  in  the  EU 
would have to deal with much higher compliance costs than companies outside the EU. This said, both 
shooting  ranges  and  demolition,  repair  and  scrap  sectors  would  not  be  impacted  on  the  international 
stage since their activities are exclusively executed on EU territory, requiring compliance with the EU 
rules.  The companies operating  in  those  sectors account  for  80%  of  the  EU  enterprises  with  exposed 
workers to lead.  For the preferred option, the impact on  competitiveness for companies working with 
lead should be moderate, although these costs could not be quantified 

Diisocyanates 

Any  additional  costs  arising  from  the  setting  of  an  OEL  and  STEL  at  the  EU  level  could  in  theory 
impact  companies  willing  to  invest  in  research  and  development  (R&D).  According  to  estimates, 
expected R&D expenditures of small companies over 40 years would be lower than the total costs for 
businesses related to the setting  of an  OEL over  the same  period  under  the  three  policy  options. The 
stricter the OEL, the higher the number of impacted small companies. Although those small companies 
would probably not dedicate all their R&D budget to the incremental compliance costs, those additional 
costs could negatively weight on their capacity to invest in R&D. When it comes to medium and large 
companies, the total costs are usually much lower than the expected R&D expenditures. Therefore, the 
expected impacts are much more limited and would not be significant.  

The impact on consumers should be very limited. The number of companies with workers exposed to 
diisocyanates is between 150 and 2 500 000, depending on the sectors. Only two sectors count less than 
1 000  companies.  All  these  sectors  are  therefore  highly  competitive  and  mature,  and  therefore  the 
incremental  costs,  which  are  limited  under  each  policy  option,  will  not  easily  be  passed  on  to 
consumers. In addition, no closures are expected under options 2 and 3, which means that they will not 
have any influence on the structure of the market or on the level of competition therein. Under option 4, 
textiles and apparel sectors could be impacted by the closure of about 50 companies. However, since 
they  represent  a  very  limited  share  of  the  total  number  of  companies  (around  2 500 000),  the  impact 
should not be significant.  

The  setting  of  EU-wide  OEL  and  STEL  for  diisocyanates  could  potentially  undermine  the 
international  competitiveness  of  the  companies  based  in  the  EU.  The  main  competitors  of  the  EU 
have  higher  limit  values  in  place  than  those  explored  in  this  impact  assessment.  However,  those 
countries  often  have  different  compliance  rules  and  methods  to  define  exposure,  which  makes  the 
comparison  difficult.  Furthermore,  since  most  of the companies in  the  different  sectors  are small  and 
medium-sized enterprises (ranging from 88% to 99.9%), it is likely that they do not have existing plants 
in  third  countries  and  operate  on  a  national  scale  only.  Therefore,  those  companies  do  not  have 

32 

 
 
incentives to transfer their activities outside the EU in view of benefiting from less costly rules for the 
protection of workers. Furthermore, companies operating in the construction and vehicle repair sectors 
(representing more than 50% of the total companies) are usually not subject to international competition 
due to the nature of the work. Finally, the total costs incurred by each of the policy options considered 
in  this  impact  assessment  report  are  limited  and  should  therefore  not  have  an  impact  on  the 
competitiveness of the EU at international level. 

6.3.4 

Impact on public authorities 

As both substances are already in the scope of the respective Directives, additional enforcement costs 
are expected to be zero. National authorities are responsible for inspecting companies to check if they 
are in compliance with the legal requirements already in the national OSH legislation transposing EU 
directives. The limit values are only one of the requirements of the Directives and not the one triggering 
inspections.  

Neither the CMRD nor the CAD contain any obligations for companies to notify public authorities of 
their  use  of  substances  covered  by  these  Directives,  including  lead  and  diisocyanates.  Instead,  the 
checks  for  compliance  by  national  authorities  take  place  during  the  regular  inspections.  Therefore, 
public authorities would not bear any additional costs linked to the processing of received notifications. 
Besides, no notification costs are foreseen resulting from any need for public authorities to notify the 
European Commission of their work to transpose the Directives, or of results of conducted inspections 
to  companies.  The  transfer  of  such  information  to  the  European  Commission  is  carried  out  in  the 
framework of the reports on the practical implementation of the EU OSH Directives, submitted by the 
Member  States  to  the  Commission  every  five  years,  in  accordance  with  Article  17a  of  Directive 
89/391/EEC. As a result, there are no notification costs for any of the options. As explained in section 
6.9, notification costs thus are not subject to offsetting in the context of the ‘one in, one out’ approach.  

Lead 

The benefits to the public authorities are composed of avoided costs of treatment (healthcare treatment 
costs  borne  by  public  authorities)  and  increased  tax  revenues.  Costs  to  the  public  authorities  will 
include transposition measures to introduce the updated limit values in their national legislation.  

Whatever  the  option,  most  of  the  Member  States  would  need  to  bear  the  costs  related  to  the 
transposition of the new limit values, approximatively EUR 500 00082 (table 8). However, those costs 
would  be  largely  compensated  by  the  benefits  under  each  option.  These  benefits  would  vary  from 
EUR 90 to EUR 130 million depending on the option retained.   

Table 8: Costs and benefits to taxpayers/public authorities – lead (compared to baseline) 

Option 2 
20 µg/100ml  
€90 000 000  

ill 

Benefits  (avoided  costs  of 
health) 
Transposition cost 
Net benefit (benefits – costs) 
 Source: External study calculation, for EU 27 

€500 000 
€89 500 000 

Option 3 
15µg/100ml  
€100 000 000 

Option 4 
4.5 µg/100ml  
€130 000 000 

€520 000 
€99 480 000 

€540 000 
€129 460 000 

82 Transpositions costs per Member State are estimated to be of EUR 20 000. 

33 

 
 
                                                      
 
Diisocyanates 

Since no Member States have an OEL and a STEL currently in place at the level of each policy option, 
all of them will need to carry out a transposition under each option. In the 19 Member States having 
already an OEL or STEL for one or several diisocyanates set in their legislation, the cost to revise it is 
estimated at EUR 30 000 for the transposition. For eight Member States without any OEL or STEL, the 
cost  estimated  is  EUR 50 000.  EU  Member  States  will  dedicate  in  total  EUR 970 000  to  the 
transposition under each of the options explored in this impact assessment. 

Member  States  will  also  benefit  from  setting  limit  values  at  the  EU  level  due  to  reduced  healthcare 
costs. They would save about EUR 1 million under option 4, while the estimated benefits are null under 
options  2  and  3.  Those  estimates  are  likely  to  be  underestimated  since  peak  exposures  could  not  be 
calculated, leading to an underestimation of the ill health cases. 

Setting an OEL and a STEL at EU level enables to carry out one single impact assessment and scientific 
opinion  rather  than  27,  one  in  each  Member  State.  Savings  are  estimated  at  about  EUR 1 750 000.  
They range from EUR 50 000 to EUR 100 000 depending on whether the Member State already has an 
OEL or a STEL in place or not.  

In conclusion, the benefits for public authorities outweigh the costs under each option: EUR 1 780 000 
for option 4 and EUR 780 000 for options 2 and 3.  

Table 9: Costs and benefits to taxpayers/public authorities – diisocyanates (in comparison to 
baseline) 

Benefits 
Transposition cost 
Net benefit (benefits – costs) 
 Source: External sStudy calculation, for EU27 

Option 2 
10 µg NCO/m3 
€1 750 000  
€970 000 
€780 000 

Option 3 
6 µg NCO/m3 
€1 750 000 
€970 000 
€780 000 

Option 4 
3 µg NCO/m3 
€2 750 000 
€970 000 
€1 780 000 

6.4 Impacts on the environment and on climate change 

Lead 

Lead  can  naturally  originate  from  the  mineral  bedrock  that  formed  the  soil.  Natural  background 
concentrations  are  difficult  to  determine,  since  lead  pollution  has  been  going  on  for  a  long  time. 
Anthropogenic  sources  of  lead  in  soil  include  the  formerly  used  lead-containing  petrol,  mining 
operations,  metal  processing  as  well  as  production,  use  and  disposal  of  lead-containing  products  like 
lead-acid  batteries,  lead  sheets  etc.  Also,  lead-containing  ammunition  have  been  deposited  at  or  near 
shooting ranges. Thus, soils in urban and industrial areas have increased concentrations of lead.  

Emissions from point sources to air, soil and water are reported in the European Pollutant Release and 
Transfer Register. About 500 facilities reported lead emissions in 2017, emitting an estimated total of 
260  tons,  with  main  contributions  from  the  energy  sector  (mainly  thermal  power  stations  and  other 
combustion  installations)  and  metal  production  and  processing  (lead  mining,  smelting  and  refining). 
The main emission is to the air (ca. 200 tons). 

Alternative  RMMs,  due  to  comply  with  a  stricter  limit  value  may  help  to  marginally  improve 
environmental exposure to lead (e.g., when a more efficient extraction system would better capture lead 

34 

 
 
 
dust). However, significant differences are unlikely to be recognised compared to the current situation. 
In any case, these alternative RMMs will not result in additional negative impacts. 

Reducing the limit values for lead is not expected to have an impact on climate change, though greater 
use of lead batteries in, e.g., electric vehicles will contribute to a reduction in the use of fossil fuels. 

Diisocyanates 

Diisocyanates are a group of synthetic substances and do not have natural sources. Most diisocyanates 
are  not  considered  as  having  persistent  qualities.  They  are  highly  reactive  and  when  released  into  an 
environment  containing  water  (for  example,  in  relation  to  air,  aquatic  environments,  and  soil) 
diisocyanates produce a polyurea crust which is insoluble and inert. In practical terms this means that 
there  is  no  direct  risk  to  the  environment  from  unreacted  diisocyanates.  For  the  same  reasons 
bioaccumulation of diisocyanates is not considered possible. Based on the above there is no identifiable 
significant impact on the environment.  

A  greater  use  of  insulating  material  based  on  diisocyanates  will  improve  the  thermal  insulation  of 
buildings  with  a  consequent  reduction  in  the  use  of  fossil  fuels  for  heating,  thus  contributing  to 
mitigating climate change. This will not be directly impacted by the introduction of limit values. 

6.5 Impacts on fundamental rights 

All  options  align  with  the  EU  Charter  of  Fundamental  Rights.  Article  31  of  the  Charter  states  that 
workers have the right to fair and just working conditions that respect their health, safety and dignity. 
This is further developed in the European Pillar of Social Rights83 which aims to build a fairer and more 
inclusive  European  Union.  The  initiative  for  lowering  the  OEL/BLV  for  lead  and  for  introducing  an 
OEL/STEL for diisocyanates will thus have a direct positive impact on fundamental and social rights, 
as it will further improve the protection of workers from the health risks posed by exposure. Taking into 
account the avoided ill-health following the implementation of new, or revised, limit values, the respect 
of these rights will also be positively impacted.  

6.6 Contribution to sustainable development 

The initiative will contribute positively to sustainable development goals on good health and well-being 
(3rd goal) and on decent work and economic growth (8th goal). A positive impact is also expected for 
the  SDG  on  industry,  innovation  and  infrastructure  (9th  goal)  and  on  responsible  production  and 
consumption (12th goal). 

6.7 Impacts on digitalisation 

None of the policy options for both lead and diisocyanates would have any impacts on digitalisation.   

83https://ec.europa.eu/info/strategy/priorities-2019-2024/economy-works-people/jobs-growth-and-
investment/european-pillar-social-rights_en  

35 

 
 
                                                      
6.8 Administrative impacts 

As explained in sections 6.3.4, neither the CMRD nor the CAD contain any notification obligations.  

For  lead,  public  authorities  could  incur  administrative  costs  if,  for  example,  they  have  to  do  more 
reporting  to  the  EU  or  there  are  other  additional  administrative  burdens.  However,  no  additional 
reporting is anticipated and any other administrative burdens for Member States’ authorities than those 
already referred in table 8 could not be identified and, therefore, quantified.  

For  companies,  since  all the  options considered in  this  impact assessment  are about revising  existing 
limit values, such a revision would not introduce any additional administrative requirements. Therefore, 
the administrative costs for companies are null under each option.   

Many activities are performed by companies working in one Member State only (micro-enterprises and 
SMEs). However, several larger and to lesser extent medium-sized companies with facilities in different 
Member  States  would  benefit  from  administrative  simplification,  owing  to  a  more  harmonious  set  of 
compliance requirements. Due to the lack of data, a quantification of those administrative savings was 
not possible. 

As  for  lead,  none  of  the  options  explored  for  diisocyanates  should  entail  additional  administrative 
burdens for Member States. The possible revision of the CAD would be limited to the setting of an OEL 
and a STEL, with no additional requirements such as new reporting activities for public authorities.  

For  companies,  as  described  above,  some  costs  are  expected.  Large  companies  would  spend 
EUR 22 230  over  40  years  while small  and  medium-sized  companies  would  dedicate  EUR 2 223  and 
EUR 11 115  respectively,  over  the  same  reference  period.  This  brings  the  total  for  all  companies  to 
€2.4bn for the whole 40-year period, as indicated in table 11 below. 

6.9 ‘One in, one out’ approach 

The administrative costs for companies operating with diisocyanates relate to the inspection on behalf 
of public authorities and are therefore not subject to offsetting in the context of the ‘one in, one out’ 
approach84. Companies manufacturing or using lead will not face any additional administrative costs as 
explained in the previous subsection. Therefore, there are no administrative costs to be offset according 
to the ‘one in, one out’ approach.  

6.10 Summary of the impacts 

The  tables  below  provide  a  summary  of  the  different  impacts  by  policy  options  for  both  lead  and 
diisocyanates.  

Lead  

Table 10: Multi-criteria analysis on lead (all impacts over 40 years and additional to the baseline) 

Impact 

Stakeholders 
affected 

BLV options (μg/100ml) 

Option 4: 4.5   Option 3: 15  

Option 2: 20  

84 Better Regulation Tool #58 ‘EU Standard Cost Model’. 

36 

 
 
                                                      
Impact 

Stakeholders 
affected 

BLV options (μg/100ml) 

Option 4: 4.5   Option 3: 15  

Option 2: 20  

Companies 

Companies 

Companies 

of 

cost 

Direct costs – compliance 
management 
Risk 
and 
measures 
discontinuation 
costs 
(one-off and recurrent) 
Monitoring (sampling and 
analysis) 
Direct costs - administrative burdens 
Company 
additional administration 
Direct costs –– total per company 
Compliance 
monitoring 
company 
Direct costs - enforcement costs 
Transposition costs 
Enforcement costs 
Monitoring costs  
Adjudication costs 
Indirect costs – other 
Firms exiting the market - 
No. of company closures 

and 
per 

costs 

Public sector 
Public sector 
Public sector 
Public sector 

Companies 

Companies 

Employment – Jobs lost 

Employment – Social cost 

International 
competitiveness 

Consumers 

Workers  & 
families 
Workers  & 
families 

Companies 

Consumers 

Internal market 

Companies 

€6 300 million 

€750  
million 

€350  
million 

€0 

€0 

€0 

€0 

€0 

€0 

€300 000  

€31 000  

€15 000  

€520 000 
€0 
€0 
€0 

29 

1 800 

€150  
million 
Substantial 
negative 
impact 

€500 000 
€0 
€0 
€0 

€480 000 
€0 
€0 
€0 

0 

0 

€0 

0 

0 

€0 

Moderate negative 
impact 

Limited negative 
impact 

Limited impacts expected 

Lowest/ 
highest BLV 
 from 4.5 to 4.5 

Lowest/ 
highest BLV 
 from 10 to 15 

Lowest/ 
highest BLV 
 from 10 to 20 

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

Public sector 

All MS 

All MS   

All MS 

Regulation 

Companies 

Cumulative impact of many changes in regulations, 
implemented or awaited 

Direct benefits – improved well-being – health 
Reduced  cases  of 
ill 
health (all endpoints, excl. 
developmental toxicity) 
Ill  health  avoided,  incl. 
intangible  costs  (M1  to 
M2) 
Avoided costs 

Workers  & 
families 

Workers  & 
families 

Companies 

Avoided costs 

Public sector  

37 

13,000 

€200 - 310  
million 

€6 million 
€130  
million 

10,500 

8,500 

€160 - 250 million  €130 - 200 million 

€5 million 
€100 
million 

€4 million 
€90  
million 

 
 
Impact 

Stakeholders 
affected 

Social policy agenda 

All 

BLV options (μg/100ml) 

Option 4: 4.5   Option 3: 15  

Option 2: 20  

Contribution to Green Deal: Chemicals Strategy for 
Sustainability towards a toxic-free environment 

Direct benefits – improved well-being – environmental 
Environmental releases 
Direct benefits – market efficiency 

All 

No impact/limited impact  

Level playing field 

Companies 

Indirect benefits  

Administrative 
simplification 

Companies 

Corporate 
Responsibility 

Social 

Companies 

A harmonisation of the BLVs leads to a level playing field, 
as all companies across all Member States follow a more 
symmetric requirement. The level-playing field increases 
with the stringency of BLVs 

Large companies, and to a lesser extent medium ones with 
facilities in different Member States, will experience 
administrative simplification, owing to a more harmonious 
set of compliance requirements. The sectors expected to 
benefit most are sectors 1, 2, 3, 6, and 15. 
Work with lead may be less perceived as a risky line of 
work associated with health issues. As a result of such an 
improved public image, companies may find it easier to 
recruit and retain staff, reducing the cost of recruitment 
and increasing the productivity of workers. 

No  cost  of  setting  BLV 
(saving 
for 
developing lower national 
BLVs)  

for  MS 

Public sector 

Benefit (MS would expectedly not 
implement lower BLV) 

Small benefit 
(some MS would 
consider 
implementing 
lower BLV) 

Source: RPA, 2021, External Study 

Diisocyanates 

Table 11: Multi-criteria analysis on diisocyanates (all impacts over 40 years and additional to the 
baseline) 

Impact 

Stakeholder
s affected 

OEL options (μg NCO/m3) 

Option4: 3 

Option 3: 6 

Option 2: 10 

Companies 

Direct costs – compliance 
Risk management 
measures and 
discontinuation costs 
(one-off and recurrent) 
Monitoring (sampling and 
analysis) 
Direct costs - administrative burdens 
Company cost of 
administration burden 
Direct costs – total per company 
Compliance, monitoring 
and administration burden 

Companies 

Companies 

Companies 

€830 million 

€10 million 

€0 million 

€11 000 million 

€11 000 million 

€4 600 million 

€2 400 million 

€2 400 million 

€1 000 million 

€5 900 

€5 600 

€2 300 

38 

 
 
Impact 

Stakeholder
s affected 

OEL options (μg NCO/m3) 

Option4: 3 

Option 3: 6 

Option 2: 10 

costs per company 
Direct costs - enforcement costs 
Transposition costs 
Enforcement costs 
Monitoring costs  
Adjudication costs 
Indirect costs – other 
Firms exiting the market - 
No.  of company closures 

Public sector 
Public sector 
Public sector 
Public sector 

Employment – Jobs lost 

Employment – Social cost 

International 
competitiveness 
Consumers 
Internal market  
Lowest to highest OEL 
Specific MSs/regions - 
MSs that would have to 
change OELs 

€970 000 
€0 
€0 
€0 

53 

100 

€8.5 million 

€970 000 
€0 
€0 
€0 

€970 000 
€0 
€0 
€0 

0 

0 

0 

0 

0 

0 

Several  sectors  are  in  price  sensitive  competitive  markets 
with many competitors outside the EU 
Limited impacts expected 

3 - 3 

3 - 6 

3 – 10 

Companies 

Workers  & 
families 
Workers  & 
families 

Companies 

Consumers 

Companies 

Public sector 

All MS except 
SE 

All MS except 
SE 

All MS except IE, 
SE, PL 

Regulation 

Companies 

Cumulative  impact  of  many  changes  in  regulations, 
implemented or awaited 

Workers  & 
families 
Workers  & 
families 

Direct benefits – improved well-being – health 
Reduced cases of ill 
health (asthma) 
Reduced cases of ill 
health (irritation) 
Ill health avoided, incl.  
intangible costs (M1 to 
M2) 
Direct benefits – improved well-being – safety 
Avoided costs 
Avoided costs 

Companies 
Public sector  

Workers  & 
families 

Social policy agenda 

All 

50 

260 

€1 - 2  
million 

0 

0 

€0 

0 

0 

€0 

€0.4 million 
€1 million 

€0 
€0 
Contribution to Green Deal: Chemicals Strategy for 
Sustainability towards a toxic-free environment 

€0 
€0 

Direct benefits – improved well-being – environmental 
Environmental releases 
Direct benefits – market efficiency 

All 

No impact/limited impact  

Level playing field 

Companies 

A  harmonisation  of  the  OEL  and  STEL  leads  to  a  level 
playing  field,  as  all  companies  across  all  Member  States 
follow  a  more  symmetric  requirement.    The  level-playing 
field  increases  slightly  with  the  stringency  of  OEL  and 
STEL 

Indirect benefits  

Administrative 
simplification 

39 

Companies 

Large companies, and to a lesser extent medium ones, with 
facilities  in  different  Member  States  will  experience 
administrative simplification, owing to a more harmonious 

 
 
Impact 

Stakeholder
s affected 

Synergy 

Companies 

Corporate Social 
Responsibility 

Companies 

OEL options (μg NCO/m3) 

Option4: 3 

Option 3: 6 

Option 2: 10 

set  of  compliance  requirements.    The  sectors  expected  to 
benefit  most  are  C20  Chemicals,  C29  Motor  vehicles  and 
C30 Transport. 
Synergies in terms of exposure reduction to other chemical 
substances  used  in  production  sectors  may  occur.    The 
specific substances will vary between the sectors. The level 
of  synergy  to  be  harnessed  will  also  depend  on  the  risk 
management measures applied in each enterprise. 
Work  with  diisocyanates may  be  perceived  as  a less  risky 
line  of  work  associated  with  health  issues.  As  a  result  of 
such an improvement in the public image, companies may 
find it easier to recruit and retain staff, reducing the cost of 
recruitment and increasing the productivity of workers. 

Avoided cost of setting 
OEL  
Source: RPA, 2021, External Study 

Public sector  €1 750 000 

€1 750 000 

€1 750 000 

7.  7. HOW DO THE OPTIONS COMPARE? 

The  main  objective  is  to  balance  health  considerations  against  economic  impacts,  by  proposing  limit 
values that are still economically feasible while protecting a maximum number of workers. The aim is 
therefore to ensure a balanced approach and to prevent industries from closures or severe disadvantages, 
as  a  result  of  the  adoption  of  stringent  OELs.  The  comparison  tables  used  to  compare  the  different 
options  against  the  baseline  scenario  in  terms  of  effectiveness,  efficiency,  feasibility  and  coherence 
apply  the  following  ranking  symbols:    '0'  –  baseline,  '≈'  –  similar  to  baseline,  from  '+'  more 
efficient/effective/feasible or coherent than baseline to '+++' – much more efficient/effective/feasible or 
coherent  than  baseline;  from  '-'  –  less  efficient/effective/feasible  or  coherent  than  baseline  to  '-  -  -'  – 
much less efficient/effective/feasible or coherent than baseline. 

Lead 

Criteria 

Effectiveness 

Efficiency 

Coherence 

Table 12: comparison of lead options  

70 µg/100ml 
(Baseline) 

20 µg/100ml 
(Option 2) 

15 µg/100ml  
(Option 3) 

4.5 µg/100ml  
(Option 4) 

0 

0 

0 

+ 

- 

++ 

++ 

- 

+++ 

+++ 

--- 

++ 

The effectiveness is analysed from the perspective of the prevention of adverse health effects. All three 
policy options are more effective in terms of workers’ protection than not revising the current EU-wide 

40 

 
 
 
 
 
biological limit value (baseline). Option 4 is the most effective policy option in terms of number of ill 
health cases avoided over 40 years (13 500 cases). Options 3 and 2 would also contribute to improving 
the protection of workers, although to a lesser extent, by preventing about 10 500 and 8 500 cases of ill 
health, respectively.  

With regard to the efficiency, the options are ranked according to a comparison of the benefits arising 
from  each  policy  option  compared  to  the  costs  they  would  entail.  Strictly  looking  at  the  monetised 
impacts, option 2 has a costs/benefits ratio close to 1 (1.2 to 1.6, depending on the methodology used to 
estimate  the  benefits  for  workers  and  their  families),  which  means  that  the  costs  associated  with  this 
option are quite close to its benefits. The costs/benefits ratio associated with option 3 indicates that the 
costs are more than double the benefits (2.1 to 2.8). These two options are therefore less efficient than 
the baseline. By contrast, the costs/benefits ratio associated with option 4 is much higher (from 14.5 to 
19.2). Thus, option 4 is therefore much less efficient than the baseline.   

However, and although it is not reflected in the above table, it is worth mentioning that the costs for 
companies under options 2 and 3 would represent less than 1% of the annual turnover and would not 
lead to any discontinuation of companies, while both would ensure a much more adequate protection of 
workers in comparison to baseline (preventing between around 8 500 and 10 350 ill-health cases). Since 
the  improvement  of  workers’  protection  is  the  main  objective,  all  the  options  could  be  seen  as  more 
cost-effective85  than  the  baseline  scenario  which  would  not  bring  any  benefits.  Furthermore,  both 
options  2  and  3  improve  the  protection  of  workers  while  preventing  closures  and  other  severe 
disadvantages for the industries. Although the benefits are slightly higher than for options 2 and 3, the 
costs arising from the investments to comply with the limit value under option 4 would be substantially 
higher than under options 2 and 3. As a consequence, 29 companies (of which 25 are small or medium-
sized enterprises) are estimated to exit the market.  

Table  13:  Comparison  of  quantified  costs  and  benefits  for  options  for  lead  (over  40  years,  in  € 
million)  

Option 2 

Option 3 

Option 4 

(20 µg/100ml) 

(15 µg/100ml) 

(4.5 µg/100ml) 

350 

4 

0.5 

90  

750 

5 

0.52 

100  

6 300 

6 

0.54 

130  

130 - 200 

160 - 250 

200 - 310 

Costs for 
businesses  

Benefits for 
businesses  
Costs for public 
authorities 
Benefits for public 
authorities 
 Health benefits 
for workers and 
families  

Source: RPA, 2021, External Study 

85  Cost-effectiveness  analyses  enable  to  quantify  the  benefits  that  would  be  generated  by  one  euro  of  costs 
imposed on society. 

41 

 
 
 
                                                      
With regard to the coherence, the options are analysed on the basis of how coherent they are with other 
EU policies (including the Charter for Fundamental Rights, the European Pillar of Social Rights and its 
Action  Plan,  the  Chemicals  Strategy  for  Sustainability  and  REACH).  Coherence  with  general  EU 
priorities and policies, as well as with the Charter of Fundamental Rights, goes hand in hand with the 
level of the limit values. The lower the limit value, the more protective of workers’ health.  

Lowering the existing limit value at the level of each policy option would ensure a better protection of 
workers’  health  and  would  be  in  line  with  the  Commission’s  commitment  to  reducing  workers’ 
exposure to hazardous chemicals. Therefore, these three options would ensure a greater coherence with 
the  Charter  for  Fundamental  Rights,  the  EU  Pillar  of  Social  Rights  and  its  Action  Plan  and  the 
Chemicals Strategy for Sustainability. Furthermore, lead has been identified as a substance of very high 
concern and placed on the candidate list for inclusion into Annex XIV to REACH since June 2018, on 
the grounds that it is a substance toxic to reproduction. Therefore, the lowering of the limit value at the 
level of all the options (except option 1) will improve the protection from a substance considered as of 
high concern and for which there is a need for vigilance.  

In addition, option 3 is coherent with the OEL recommended by two Interest Groups within the ACSH, 
namely the employers’ and governments’ Interest Groups. The workers’ Interest Group recommended 
an  OEL  at  the  level  of  option  4.  Therefore,  option  3  is  the  most  coherent  as  it  ensures  the  same 
coherence with the other EU policies as options 2 and 4 while being coherent with the opinion endorsed 
by a majority of members within the ACSH. 

Diisocyanates 

Criteria 

Effectiveness 

Efficiency 

Coherence 

Table 14: comparison of diisocyanates options  

No EU limit 
values 
(Baseline) 

0 

0 

0 

10 µg/m³ 
(Option 2) 

6 µg/m³  
(Option 3) 

3 µg/m³  
(Option 4) 

+ 

- 

++ 

+ 

- 

+++ 

++ 

--- 

++ 

With  regard  to  the  effectiveness,  the  options  are  analysed  from  the  perspective  of  the  prevention  of 
adverse health effects. According to the available data, options 2 and 3 would not bring any additional 
benefits compared to the baseline. However, as explained above, the data available does not allow for a 
comprehensive analysis since the ill-health cases due to peak exposures could not be calculated, which 
results in a significant underestimation of the benefits. Therefore, the benefits of setting an OEL (and its 
associated STEL) at the level of one of these options would in practice be higher (the stricter the STEL 
the higher the avoided ill health cases) and this qualitative analysis is reflected in the above table (each 
policy option is higher in terms of effectiveness than the baseline). The same data limitations apply to 
option 4, which would in theory enable to prevent about 300 cases of asthma and irritation, while this 
figure should be higher in practice. The benefits related to option 4 should be higher than under options 
2 and 3.  The lower the limit value, the more protective of workers’ health.  

With regard to the efficiency, the options should be ranked according to a comparison of the benefits 
arising from each policy option compared to the costs they would entail. However, since the benefits 

42 

 
 
 
are  underestimated  due  to  data  limitations,  a  purely  quantitative  comparison  of  the  options  does  not 
allow to properly assess their efficiency. As explained above, the three options should produce benefits 
by reducing the number of ill health cases resulting from the exposure to diisocyanates. Still, it is likely 
that the costs would outweigh the benefits for all policy options. Considering that the costs of option 4 
are not only the highest but also that this option is the only one expected to lead to  company closures 
and job losses, it is rated as the least efficient. 

Table 15: comparison of quantified costs and benefits for diisocyanates options (over 40 years, in 
€ million)  

Option 2 

Option 3 

Option 4 

10 µg NCO/m3 

6 µg NCO/m3 

3 µg NCO/m3 

5 600 

13 410 

14 230 

0 

0.97 

1.75 

N/A 

0 

0.97 

1.75   

0.4 

0.97 

2.75  

N/A 

0.8 - 2.2 

Costs 
businesses 
Benefits 
businesses 

for 

for 

Costs  for  public 
authorities 
Benefits for public 
authorities 
Health benefits for 
and 
workers 
families 

Source: RPA, 2021, External Study 

With regard to the coherence, the options are analysed on the basis of how coherent they are with other 
EU policies (including the Charter for Fundamental Rights, the European Pillar of Social Rights and its 
Action  Plan,  the  Chemicals  Strategy  for  Sustainability  and  REACH).  Coherence  with  general  EU 
priorities and policies, as well as with the Charter of Fundamental Rights, goes hand in hand with the 
level of the OELs.  

Setting  limit  values  at  the  level  of  each  policy  option  would  ensure  a  better  protection  of  workers’ 
health  and  would  be  in  line  with  the  Commission’s  commitment  to  reducing  workers’  exposure  to 
hazardous chemicals. Therefore, these three options would ensure a greater coherence with the Charter 
of  Fundamental  Rights,  the  European  Pillar  of  Social  Rights  and  its  Action  Plan  and  the  Chemicals 
Strategy for Sustainability. Furthermore, and whatever the option retained, the setting of an OEL and a 

43 

 
 
 
 
 
 
 
 
 
 
STEL will be coherent with and would complement the REACH restriction introducing specific training 
requirements for workers using diisocyanates. Therefore, the lowering of the limit value at the level of 
all  the  options  (except  option  1)  will  improve  the  protection  from  a  substance  considered  as  of  high 
concern and for which there is a need for vigilance.  

In addition, option 3 is coherent with the OEL unanimously recommended by the ACSH in its opinion. 
Therefore, option 3 is the most coherent as it ensures the same coherence with the other EU policies as 
options 2 and 4 while being coherent with the opinion of the ACSH.  

8.  8. PREFERRED OPTION 

Taking into account the impacts mentioned in the previous section as well as the opinions of the ACSH, 
including the positions of its different interest groups, the preferred options are: 

8.1 Lead 

Option  3  ensures  a  balanced  approach  between  adequate  protection  of  workers  at  the  EU  level  and 
prevention of closures and other severe disadvantages for the concerned sectors. Furthermore, it ensures 
coherence with key EU policies as demonstrated in the previous section.  

The  three  Interest  Groups  of  the  ACSH,  in  its  opinion,  agree  on  the  need  to  revise  downwards  the 
existing BLV as well as the OEL to better protect workers. Furthermore, they agree blood lead exposure 
is the best exposure metric to assess exposure. The preferred option is based on the above analysis that 
takes into account the RAC and ACSH opinions, together with relevant feasibility aspects.  

A BLV equal to 15 µg/100ml blood, accompanied by an associated OEL equal to 0.03mg/m3 as an 8-
hour TWA is therefore the preferred option.  

8.2 Diisocyanates 

Option 3 ensures a balanced approach between preventing companies from closures or severe economic 
disadvantages  while  providing  an  adequate  protection  of  workers  at  the  EU  level.  It  also  ensures 
coherence with key EU policies. This option 3 is also coherent with the ACSH opinion, in which the 
three Interest Groups recommended to set an OEL of 6 µg NCO/m3 (and an associated STEL of 12 µg 
NCO/m3).    An  OEL  equal  to  6  µg/m³,  accompanied  with  an  associated  STEL  equal  to  12  µg/m³,  a 
dermal and respiratory sensitisation notation and a skin notation is therefore the preferred option.  

However, as recommended by the ACSH, a transitional value at the level of option 2 (10 µg/m³) with 
an associated STEL equal to 20 µg/m³ should apply until 31 December 2028. This transitional value is 
considered as necessary for technical measurement feasibility reasons and to give sufficient time to the 
industry  to  implement  the  necessary  risk  management  measures,  in  particular  in  downstream  sectors. 
This should be complemented by health surveillance of workers to detect any early onset of ill-health 
and  subsequent  management  of  the  individual  worker  to  prevent  further  risks  due  to  exposure  to 

44 

 
 
 
 
 
 
diisocyanates.  Collectively,  this  provides  a  high  level  of  worker  protection.8.3  Overall  impact  of  the 
preferred options. 

Due to a lack of data, the impacts of a combination of several limit values for diisocyanates in the form 
of  a  transitional  measure  and  of  the  setting  of  notations  could  not  be  quantified.  For  that  reason,  the 
costs  and  benefits  described  below  are  those  for  the  preferred  option  only,  without  any  transitional 
measures  and  notations.  However,  it  is  reasonable  to  consider  that  accompanying  the  new  EU 
diisocyanates OEL with transitional measures would have limited impacts on the benefits and moderate 
impacts  on  the  costs.  It  is  all  the  more  true  that  the  duration  of  these  transitional  measures  will  be 
limited and it is likely that some companies have already started to make the necessary investments in 
anticipation of the new or more stringent OELs to come. 

It is difficult to predict with any certainty the expected future level of reduction in the number of cases 
of  ill-health due  to exposure to  both lead  and  diisocyanates.  However,  it is reasonable to  predict  that 
following  the  implementation  of  the  new  and  revised  limit  values,  exposures  will  reduce  with  a 
consequent  reduction  in  the  number  of  cases  of  ill-health.  Within  the  framework  of  the  evaluations 
carried out under Article 17a of Directive 89/391/EEC, consideration could be given to developing a set 
of objective indicators specific to each substance for which a limit value has been set under CAD and 
CMRD. 

8.3.1 

Impact on workers 

The preferred options considered in this impact assessment should result in benefits in terms of avoided 
work-related  ill-health,  and  related  monetised  health  benefits  including  avoidance  of  intangible  costs 
such as the reduced quality of life, the suffering of the workers and their families, the pain, etc. For lead 
it is estimated that about 10 500 cases of ill-health could be prevented, and its monetised health benefit 
is assessed as ranging from EUR 160 million to EUR 250 million. Regarding diisocyanates, the lack of 
data does not allow to quantify the benefits for workers. However, it is largely agreed among relevant 
stakeholders,  including  social  partners,  that  the  setting  of  a  STEL  would  result  in  a  decrease  of  the 
number of ill-health cases.  

8.3.2 

Impact on business, including SMEs 

As regards costs incurred for risk reduction measures, the preferred options will affect operating costs 
for companies which will have to adjust the working practices to comply with the new BLV and OEL 
for  lead  and  OEL,  STEL  and  notations  for  diisocyanates.  This  will  consist  of  incremental  costs  of 
RMMs (including respiratory protective equipment (RPE)), cost of health surveillance, monitoring costs 
and  training  costs86.  The  costs  to  business  over  the  next  40  years  are  estimated  to  be  about 
EUR 750 million for companies operating with lead and EUR 13.5 billion for companies dealing with 
diisocyanates.  

For  lead,  the  average  additional  costs  per  company  would  be  about  EUR 30 000  over  40  years.  This 
represents less than 1% of their turnover and should therefore not lead to any closures. Furthermore, the 
impacts on the expenses in research and development and on consumers should be very limited.  

As for diisocyanates, each of the companies would spend on average about EUR 6 000 over 40 years. 
Since  most  of  these  costs  are  related  to  monitoring  tasks,  they  spread  over  the  reference  period. 

86 Companies operating with lead will only face costs of RMMs.  

45 

 
 
 
 
                                                      
Moreover,  while  all  companies  must  comply  with  limit  values,  monitoring  and  the  administrative 
burden  of  monitoring  can  be  reduced,  according  to  CAD,  as  there  is  no  need  for  monitoring  if 
companies  can  demonstrate  adequate  protection  by  other  means.  It  is  therefore  possible  that  many 
micro-enterprises  (numerous  in  the  construction  and  vehicle  repair  sectors)  will  not  be  required  to 
monitor  their  compliance.  In  such  a  case,  the  above  indicated  monitoring  and  administrative  costs 
would  be  significantly  overestimated.  Regarding  one-off  costs,  companies  operating  in  textiles  and 
apparel sectors would need to  bear costs of  EUR 4.5 billion and EUR 10.3 billion respectively. Since 
most of the companies operate in sectors with a high degree of competition, the impacts on consumers 
will be limited.  

The  setting  of  new  or  revised  limit  values  should  bring  benefits  to  companies,  including  for 
diisocyanates,  although  these  could  not  be  quantified.  For  example,  this  would  lead  to  cost  savings 
related  to  sick  leave,  labour  productivity  and  other  administrative  and  legal  costs.  However,  these 
benefits are much more limited compared to the costs arising from the setting of the limit values.  

99% of the companies working with lead and diisocyanates are SMEs and, therefore, these have been 
the focus of this report’s cost analysis.  

8.3.3 

Impact on competition and competitiveness 

Companies  that  are  already  complying  with  any  limit  value  being  assessed  will  be  impacted  less  in 
terms  of  their  competitiveness  costs  following  the  introduction  of  a  lower  OEL,  STEL  or  BLV  as 
appropriate. This is particularly relevant for companies working  with diisocyanates in Sweden, which 
has lower national OELs for a few of them.  

However,  whilst  this  might  make  them  more  cost-competitive  against  companies  working  in  other 
Member States, most of the work done with lead and diisocyanates is carried out in fixed installations 
(e.g., lead battery manufacturing and recycling / primary manufacture of diisocyanates). Furthermore, 
the  costs  related  to  the  compliance  with  the  preferred  options  should  not  have  significant  impacts  in 
terms of competition. However, companies working with lead could be less competitive compared to 
those producing lead-free alternative products (e.g., ceramic frit, alloys or crystalline glass). 

Regarding international competitiveness,  only three non-EU countries have currently a BLV for lead. 
However, most of them have an OEL which would correspond to a BLV of 30 µg/100ml. Therefore, the 
impact on companies working with lead should be moderate. When it comes to diisocyanates, the main 
competitors  of  the  EU  have  higher  limit  values,  which  could  undermine  the  competitiveness  of 
companies  operating  in  markets  characterised  by  a  high  price  sensitivity.  However,  the  potential 
consequences  are  mitigated  by  several  factors,  including  the  limited  incremental  costs  for  companies 
and the non-international nature of some of the concerned markets.  

8.4 Subsidiarity, proportionality and REFIT 

In  view  of  the  available  scientific  evidence,  it  is  necessary  to  review  the  OEL/BLV  for  lead  and  its 
inorganic compounds and to introduce a limit value for diisocyanates. The protection of workers’ health 
against  risks  arising  from  exposure  to  these  substances  is  already  covered  by  EU  legislation,  in 
particular by the CAD and the CMRD, which can be amended only at EU level. The preferred options 
build  on  long  and  intensive  discussions  with  all  stakeholders  (representatives  from  workers’ 
associations, representatives from employers' associations, and representatives from governments) that 
helps to ensure that principles of subsidiarity and proportionality are well respected.  

46 

 
 
Updating  the  CAD  and  the  CMRD  is  an  effective  way  to  ensure  that  preventive  measures  would  be 
updated  accordingly  in  all  Member  States,  providing  a  uniform  level  of  minimum  requirements 
designed to guarantee a better standard of health and safety and thus minimising the disparities in health 
and safety protection levels of workers between Member States. 

Although  competition  in  the  internal  market  not  being  strongly  impacted  by  the  revision  of  the 
OEL/BLV  for  lead  and  its  inorganic  compounds  and  by  introducing  an  OEL  for  diisocyanates,  the 
harmonisation of minimum requirements would contribute to a level playing field for operators in the 
internal  market.  Updating  the  CAD  and  the  CMRD  therefore  complies  with  the  principle  of 
subsidiarity. 

The proportionality principle is respected as the preferred option is limited to introducing an OEL and 
a STEL for diisocyanates by revising the annex to the CAD and by revising the limit values for lead by 
amending  the  annexes  to  the  CMRD  on  the  basis  of  the  scientific  and  technical  data  available.  This 
initiative  aims  to  make  a  step  forward  to  achieve  the  objectives  set  to  improve  health  and  safety  of 
workers. The preferred options ensure a balanced approach, i.e.,  preventing companies from closures or 
severe economic disadvantages while providing an adequate protection of workers at the EU level. The 
proposal is balanced and justified in light of the accrued and longer-term benefits in terms of reducing 
health risks arising from workers' exposure to lead and to diisocyanates and preventing occupational ill-
health. Therefore, it achieves the objectives of the Directives at the least cost.  

Companies working with diisocyanates will be required to take additional actions to comply with the 
limit  values;  namely,  by  introducing  additional  Risk  Management  Measures,  or  reinforcing  existing 
ones.  Nevertheless,  without  limit  values  at  EU  level,  disparities  in  the  protection  of  workers  from 
exposure to diisocyanates would remain. Besides, although Risk Management Measures will imply one-
off costs initially, these will later be compensated by savings. For instance, investing in local exhaust 
ventilation systems will reduce the need to use respiratory protective equipment, which is characterised 
by  low  one-off  yet  high  recurrent  costs.  When  it  comes  to  lead,  the  need  to  take  new  action  will  be 
limited, as no additional monitoring or administrative measures will be required.     

As shown above, the estimated costs outweigh the quantified benefits for all the options. The selection 
of  the  most  appropriate  option  per  group  of  substances  cannot  be  done  merely  on  the  basis  of  a 
costs/benefits  ratio  comparison.  Due  to  data  limitations  (see  section  6.1),  the  assessment  of 
proportionality  needs  to  go  beyond  a  purely  mathematical  comparison  of  the  costs  and  benefits.  The 
calculations presented in the report are those which could be quantified, which was easier for the costs, 
as these are usually more certain and tangible than the benefits in the area of occupational safety and 
health. Besides, important economic benefits like those linked to reputational risks and their impacts in 
terms of business opportunities and the abilities to hire and retain skilled staff, could not be quantified. 
The  limitation  of  benefit  calculations is  particularly  relevant  for  diisocyanates. The  health  benefits  of 
the STEL could not be calculated, and consequently, neither could the monetised benefits, which does 
not allow for a full picture. Nevertheless, the preferred option was supported by the Employers’ Interest 
Group  of  the  ACSH,  which  suggests  that  the  costs,  although  high,  are  bearable,  and  they  would  not 
represent an insurmountable burden for businesses. Moreover, the costs are calculated for a total of 40 
years, being therefore substantially lower when considered in annual terms. In addition, when the costs 
are  presented  in  relation  to  companies’  turnover,  the  preferred  options  both  for  lead  and  for 
diisocyanates represent limited costs (e.g., less than 1% of turnover for companies working with lead).  

For diisocyanates, the preferred option includes a transitional measure to mitigate burdens and support 
compliance which has been discussed and agreed by the relevant stakeholders, including in the opinion 
of  the  ACSH.  This  transitional  measure  contributes  to  the  proportionality  of  the  preferred  option  by 

47 

 
 
ensuring a more appropriate period for businesses to adapt. While the preferred option for lead has the 
support of employers and national governments represented within the ACSH, the preferred option for 
diisocyanates  is  fully  supported  by  all  the  interest  groups  within  the  same  Committee.  For 
diisocyanates, since there are currently no EU limit values, all  Member States will be affected by the 
preferred option, although Member States with no limit values might be more affected than those with 
limit values, even if these are higher than the preferred option. For lead, some Member States might be 
particularly  affected  by  the  proposed  options.  Many  of  the  sectors  working  with  lead  are  particularly 
present in France, Germany, Italy, Poland and Spain. Since, in addition to this, the current limit values 
in  those  Member  States  are  higher  than  the  proposed  option,  it  is  likely  that  they  be  slightly  more 
affected.  Furthermore,  the  preferred  options  offer  a  certain  flexibility  to  Member  States.  In  line  with 
Article  153(4)  of  the  TFEU,  setting  OELs  at  EU  level  does  not  prevent  Member  States  from 
maintaining  or  introducing  more  stringent  protective  measures  (i.e.,  lower  limit  values).  However, 
Member  States  cannot  set  higher  limit  values  than  the  ones  set  in  the  annexes  to  the  CAD  and  the 
CMRD.  

Finally,  regarding  the  simplification  and  the  efficiency  improvement  of  the  existing  legislation,  the 
preferred option per group of substances eliminates the need for Member States to conduct their own 
scientific analysis to revise the OEL/BLV for lead or to introduce an OEL for diisocyanates. Employers 
also  benefit  from  the  simplification  in  ensuring  legal  compliance,  particularly  those  operating  in 
different Member States. 

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

9.1 Monitoring arrangements 

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

Table 16: Indicators and monitoring arrangements/data sources 

Specific objective 

To 
the 
increase 
effectiveness  of  the 
CMRD and the CAD 
(specific objectives 1 
and 2). 

Operational 
objective 
The 
reduction  of 
occupational 
ill-health 
in 
the EU. 

48 

Indicators  Monitoring  arrangements/data  sources 
for monitoring indicators 
The data sources for the monitoring of this 
indicator are:  

The  number 
of  cases  of 
occupational 
ill-health  in 
the EU. 

to 

Data  notified  by  employers 
the 
competent  national  authorities  as  regards 
record keeping in accordance with national 
law  and/or  practice  as  resulting  from 
occupational exposure to lead in accordance 
with Art. 15, 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  implementation  reports  on  CAD 
and  CMRD  on  the  implementation  of  the 
directives,  submitted  in  accordance  with 
Art. 17a of Directive 89/391/EEC. The next 

 
 
 
 
To  achieve  a  more 
balanced 
and 
effective  protection 
of workers across the 
EU  against  lead  and 
diisocyanates, 
thereby  contributing 
to  a  reduction  in  the 
of 
burden 
occupational 
ill-
health 
(Specific 
objective 3). 

The 
reduction  of 
costs  related 
to 
occupational 
ill-health  for 
economic 
operators and 
for 
social 
security 
systems 
the EU. 

in 

costs 
The 
related 
to 
occupational 
ill-health for 
economic 
operators 
(e.g.,  loss  of 
productivity
)  and  social 
security 
systems 
the EU. 

in 

evaluations  will  be  for  the  periods  2018-
2022, 2023-2027 and 2028-2032. 

The  monitoring  of  this  indicator  would 
require  the  comparison  of  the  expected 
figures  on  the  burden  of  occupational  ill-
health 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 cases of occupational ill-
health. The  cases  of  occupational  ill-health 
accounted  for  should  be  those  related  to 
exposure 
and  diisocyanates 
respectively,  for  example,  but  not  limited 
to, 
toxicity, 
haematological 
effects, 
cardiovascular 
effects  and  developmental  toxicity  in  the 
case  of  lead,  and  occupational  asthma, 
bronchial 
sensitisation, 
isocyanate 
hyperresponsiveness, 
dermal 
occupational disease in the latter case.  

neurotoxicity, 

renal 

lead 

and 

to 

A  two-stage  compliance  assessment  (transposition  and  conformity  checks)  will  be  carried  out  by  the 
Commission for the transposition of the limit values. At workplace level, employers  must ensure that 
the exposure does not go above the limit values set out in the annexes to the CAD and the CMRD. 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 the two Directives.   

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. 

Legislative  action  needs  to  be  followed  up  through  effective  implementation  at  the  workplace. 
Companies have a broad range of tools, information and good practices provided by EU-OSHA in the 
context of a Healthy Workplaces Campaign on dangerous substances87. 

87  The  campaign  pursued  several  objectives,  including  raising  awareness  on  the  importance  of  preventing  risks 
from dangerous substances, promoting risk assessment, heightening awareness of risks to exposure to carcinogens 
at work or increasing knowledge of the legislative framework. It was carried out in 2018-2019. 

49 

 
 
 
                                                      
9.2 Evaluation arrangements 

In accordance with Article 17a of Directive 89/391/EEC, every five years, Member States are required 
to  submit  a  report  to  the  Commission  on  the  practical  implementation  of  the  EU  OSH  directives, 
including  Directive  98/24/EC  and  Directive  2004/37/EC.  Using  these  reports  as  a  basis,  the 
Commission is required to evaluate the implementation of  the directives and, to inform the European 
Parliament, the Council, the European Economic and Social Committee and the ACSH of the results of 
this  evaluation  and,  if  necessary,  of  any  initiatives  to  improve  the  operation  of  the  regulatory 
framework. The next evaluations will be for the periods 2018-2022, 2023-2027 and 2028-2032.  

A key indicator to evaluate the implementation of the EU OSH Directives, and therefore the CAD and 
the CMRD, is the full and correct transposition by the Member States. On the one hand, Member States 
should notify the Commission of their transposition of EU Directives into national legislation. Where 
they fail to do so (non-communication), do it only partially (partial communication), and/or fail to fully 
transpose  the  Directive  in  an  accurate  and  correct  manner,  the  Commission  can  launch  infringement 
procedures.  

Until recently the number of binding limit values under CAD and CMRD was limited, and the above 
evaluations  tended  not  to  address  specific  chemicals  and  instead  had  a  focus  on  the  general 
requirements  of  the  directives.  Following  successive  legislative  updates,  there  is  now  a  significant 
number of limit values. Therefore, for future evaluations under Article 17a of Directive 89/391/EEC, it 
will be appropriate to consider developing a range of indicators to enable an assessment of the practical 
implementation  of  the  substance-specific  limit  values  to  be  carried  out  in  the  future,  together  with  a 
continuation of the current practice of evaluating the general requirements of the directives. 

50 

 
 
 
 
ANNEX 1: PROCEDURAL INFORMATION 

1.  LEAD DG, DECIDE PLANNING/CWP REFERENCES 

Lead DG: Directorate-General Employment, Social Affairs and Inclusion, Unit C2 - Health and Safety 
at Work, EU-OSHA.  

2.  ORGANISATION AND TIMING 

A first consultation of the Occupational Safety and Health Inter-service Steering Group (OSH ISG) on 
the draft Impact Assessment Report (IAR) was launched on 7 March 2022 with a meeting scheduled for 
10  March  2022.  12  services  (SG,  SJ,  BUDG,  GROW,  ENER,  ENV,  RTD,  CNECT,  EAC,  SANTE, 
JUST, ESTAT) as well as EU-OSHA were consulted and invited to participate in the meeting. Most of 
the comments provided by the services were addressed in the revised draft IAR. 

A second consultation of the ISG on the revised draft IAR was launched on 29 June 2022 with a second 
meeting scheduled on 6 July 2022. This second consultation was carried out with the same services as 
for  the  first  consultation.  DG  EMPL  took  most  of  these  comments  into  consideration  in  the  revised 
version of the draft IAR.  

A third consultation of the ISG, on the legislative proposal, was launched on 19 October 2022, with a 
meeting scheduled on 24 October 2022. DG EMPL took the comments into consideration in the revised 
version of the legislative proposal.  

3.  CONSULTATION OF THE RSB 

The draft IAR for this initiative was submitted to the RSB on 14 September 2022 and the meeting with 
the RSB took place on 12 October 2022. Following this meeting, the RSB gave a positive opinion with 
reservations on 14 October 2022.  

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

Table 1: RSB comments and corresponding changes 

RSB opinion’s comments 
The  report  should  address  upfront  the  coherence 
of  the  initiative  with  the  REACH  Restriction 
Regulation  (Regulation  (EU)  2020/1149)  on 
diisocyanates and the need to act now given their 
similar  objectives  and  the  REACH  Restriction 
Regulation’s imminent entry into force in 2023.  

Corresponding changes to the draft IAR 
The  revised  report  includes  a  more  nuanced 
reflection  on  the  complementary  benefits  of  the 
introduction  of  limit  values  for  diisocyanates  and 
the recently adopted restriction under REACH that 
requires  the  mandatory  training  of  workers  who 
may  be  exposed  to  diisocyanates.  It  explains  that 
this  contributes  to  the  common  aim  of  OSH  and 
REACH  to  replace  harmful  chemicals  by  less 
harmful ones. This is discussed in the introduction 
and in section 2.2.3.2. 

It should be clear about the relevance of the 2017 
ex-post evaluation of the EU Occupational Safety 
and  Health  Directives  including  the  Chemical 
Agents  Directive  and  Carcinogens  and  Mutagens 
Directive. 
For  lead,  the  initiative’s  potential  contribution  to  The  revised  report  clarifies  in  section  4.3.5  that, 

The  revised  report  better  explains  that  the  2017 
ex-post  evaluation  identified  the  main  issues 
concerning  the  effectiveness  and  relevance  of  the 
CAD  and  the  (then)  CMD,  but  that  it  did  not 
provide sufficient quantitative data (Section 2.1).  

51 

 
 
the  Europe’s  Beating  Cancer  plan  should  be 
qualified based on current scientific knowledge. 

The  report  should  better  present  the  dynamic 
baseline. It should be more transparent on the data 
used  for  lead  regarding  exposed  workers  and 
concentrations and clarify the baseline assumption 
that  exposure  concentrations  in  lead  will  remain 
stable.  It  should  better  describe  how  the  main 
markets using the two substances will be impacted 
by  the  EU  Green  Deal  and  the  consequent 
electrification of transport, phasing out of internal 
combustion  engines,  and  overall  use  of  greener 
and  safer  materials.  For  di-isocyanates  the  report 
should  provide  evidence  supporting  a  growing 
demand. The report should explain to what extent 
the  trend  to  automate  industrial  processes  and  its 
consequence of reducing the exposure of workers 
would  affect  the  estimated  future  disease  burden 
and  how  these  trends  have  been  factored  in  the 
dynamic baseline. 
The  report  should  explain  why  the  option  of  a 
phasing  out  of  the  use  of  lead  is  not  considered 
given that lead is already banned in some Member 
States and alternatives exist. 

The  report  should  better  describe  all  relevant 
(quantified  and  not-quantified)  costs  and  benefits 
and classify them correctly for the purpose of the 
One In, One Out approach. It should better explain 
why  the  benefits  for  the  two  options  on  di-
isocyanates  (including  the  preferred  one)  are  not 
estimated.  It  should  better  justify  the  absence  of 
enforcement and notification costs. 

The  report  should  provide  further  details  on  the 
methodological  limitations  and  uncertainties  and 
explain how they affect the calculations. 

although the main adverse health effects resulting 
from exposure to lead are on reproductive health, 
in  rare  cases  it  could  cause  cancer,  which  a 
reduction of limit values could further prevent.  
The revised report provides the sources of the data 
used  to  determine  the  baseline  scenario  (Section 
5.2). 
industry 
developments 
(such  as  automatisation)  are 
factored  into  it.  The  revised  text  also  reflects  on 
the impact of the Green Deal and  the  Renovation 
Wave. 

It  also  better  explains  how 

Under  section  5.3  (options  discarded  at  an  early 
stage),  the  revised  report  includes  a  new  section 
(5.3.1)  on  the  phasing  out  of  the  use  of  lead.  It 
explains  in  detail  why  it  was  not  considered  a 
realistic  policy  option,  as  lead  remains  necessary 
for  a  number  of  critical  purposes  in  a  range  of 
sectors  including  construction  activities  and  in 
batteries  for  fossil  fuel  and  electric  vehicles. 
Besides, it clarifies that the CMRD does not allow 
for  banning  the  use  of  substances  and  reflects  on 
the lack of benefits that a ban on lead would have 
on  workers  who  are  exposed  to  materials  for 
which lead was used in the past.  
A  more  balanced  analysis  of  the  quantifiable  and 
non-quantifiable  costs  is  provided  throughout  the 
report,  and  the  analysis  of  the  one  in  one  out 
approach is reinforced in section 6.9.  
It also explains the methodological limitations that 
do  not allow  for an  estimation  of the benefits for 
diisocyanates (sections 5.4.2 and 6.1) 
The  absence  of  additional  enforcement  and 
notification costs is explained in sections 6.3.4 and 
6.8. 
Section  6.1  on  the  analytical  methodology  and 
Annex  4  in  the  revised  report  include  a  detailed 
explanation  of  the  data  limitations  and  of  the 
sensitivity analysis that was carried out. Especially 
for  diisocyanates,  it  explains  how  the  lack  of 
scientific  data 
the  exposure-risk 
relationship  limits  the  estimation  of  ill-health 
cases,  and  how  this  affects  the  cost  benefit 
calculations.  

related 

to 

In  particular,  it  should  provide  further  details  on  Further  details  on  the  estimation  of  companies 

52 

 
 
has 

proportionality 

discontinuing  their  activities  are  provided  in 
section 6.3.2. 
The  revised  report  reflects  on  this  possibility  yet 
clarifies that  the  transfers could  not  be  quantified 
due to a lack of data (Section 6.2.2.) 
The 
been 
assessment 
improved,  by  providing  a  more  critical  approach. 
It  considers  additional  actions 
that  would 
potentially have to be taken by companies. It also 
provides a more nuanced analysis of the costs and 
benefits  and  the  methodological  limitations  for 
carrying  out 
therefore  better 
justifying  why  the  proportionality  assessment 
cannot  be  done  solely  on  the  basis  of  a  purely 
mathematical comparison.  
More  detailed  explanations  of  the  evaluation 
arrangements are provided in section 9.2.  

calculations, 

strengthen 

how  the  number  of  companies  discontinuing 
activities is estimated. 
It  should  also  consider,  at  least  qualitatively,  the 
transfer  of  jobs  to  companies  offering  alternative 
solutions. 
The  report  should  better  justify  the  choice  of  the 
preferred  option 
substances  and 
for  both 
significantly 
their  proportionality 
assessments  given  that  the  costs  outweigh  the 
benefits  for  the  preferred  option  on  lead  and  the 
preferred  option  on  di-isocyanates  imposes  the 
high  costs  without  any  quantified  benefits.  The 
report  should  bring  together  all  quantified  and 
non-quantified costs and benefits and demonstrate 
that the initiative meets the objectives at least cost. 
The  report  should  specify  how  and  by  when  the 
initiative  will  be  evaluated.  The  indicators  and 
proposed  monitoring  of  all  specific  objectives 
should be included in the report. 

4.  EVIDENCE, SOURCES AND QUALITY 

Risk Assessment Committee’s Opinions 

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

RAC  prepares  the  opinions  of  the  (ECHA  related  to  the  risks  of  substances  to  human  health  and  the 
environment.  RAC  examines  among  others  the  proposals  for  harmonised  classification  and  labelling, 
evaluates whether the proposed restriction on manufacture, placing on the market or use of a substance 
is appropriate in reducing the risk to human health and the environment, and assesses the applications 
for authorisation of chemicals. Moreover, opinions from RAC also support Union regulatory activity in 
the field  of  occupational  safety  and  health.  More information about  what this  committee  does can  be 
found on the website of ECHA88. 

RAC develops high quality comparative analytical knowledge and ensures that Commission proposals, 
decisions  and  policy  relating  to  the  protection  of  workers’  health  and  safety  are  based  on  sound 
scientific evidence. Based on a Service Level Agreement (SLA) signed by DG EMPL and ECHA, this 
Committee assists the Commission delivering scientific evaluations, upon request, on the toxicological 
profiles of each of the selected priority chemical substances in relation to their adverse health effects on 
workers.  These  scientific  evaluations  shall,  where  appropriate,  include  proposals  for  Occupational 
Exposure  Limit  values  (OELs),  Short  term  Occupational  Exposure  Limit  Values  (STELs)  biological 
limit  values  (BLVs)/biological  guidance  values  and/or  notations.  Based  on  such  opinions,  the 
Commission  will  propose  occupational  exposure  limits  for  the  protection  of  workers  from  chemical 
risks, to be set at Union level pursuant to Council Directive 98/24/EC, Council Directive 148/2009/EC, 
and Directive 2004/37/EC of the European Parliament and of the Council.  

88 https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment  

53 

 
 
 
                                                      
Members  of  RAC  are  highly  qualified,  specialised,  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  RAC  opinion  on  scientific 
evaluations for lead and diisocyanates. 

RAC opinion on lead 

The RAC opinion proposes a BLV of 15 µg lead/100ml blood for lead and its inorganic compounds and 
an OEL of 0.004 mg lead/m3 (inhalable fraction) for lead and its inorganic compounds. 

RAC opinion on diisocyanates 

A  threshold  for  bronchial  hyper-responsiveness  or  for  the  development  of  asthma  could  not  be 
observed. However, an OEL defined as an 8-hour time weighted average (TWA) exposure based on the 
‘NCO group’ can be obtained from the exposure - excess risk relationships for hyperresponsiveness or 
diisocyanate asthma as derived below, based on excess risk over a working life period. 

The exposure - response relationship was derived, in µg/m3 NCO in air. 

Table 2: Exposure-risk relationship 

Excess risk over a working life period 

STEL: 

Exposure - response relations in 
µg/m3 NCO in air 

A  15-

01% 
0.5% 
1% 
2% 
3% 
4% 
5% 

<0.025 
0.027-0.040 
0.055-0.070 
0.12-0.19 
0.22-0.33 
0.40-0.48 
>0.67 

minutes Short Term Exposure Limit (STEL) value which is maximally a factor 2 higher than a derived 
OEL  based  on  the  exposure  -  excess  risk  relationship.  This  STEL  value  should  not  exceed  6  µg/m3 
NCO. 

Notations for skin sensitisation, respiratory sensitisation, ‘skin’ are warranted. 

Studies performed by external consultants 

The Commission launched on 30 April 2020 an open call for tender89 in order to collect information on 
substances with the view to analyse health, socio-economic and environmental impacts in connection 
with  possible  amendments  of  Directive  98/24/EC  (Chemical  Agents)90  and  Directive  2009/148/EC 
(Asbestos).  

89 Call for Tender documents available at: https://etendering.ted.europa.eu/cft/cft-display.html?cftId=3559 
90 Following the adoption of CMRD the revised limit values for lead will be adopted under CMRD and not CAD. 

54 

 
 
 
 
                                                      
The contract started on 28 October 2020 and lasted 10 months. The outcome of this study provides the 
main  basis  for  this  Impact  Assessment  Report  and  is  summarised  in  the  relevant  sections  of  this 
document. 

55 

 
 
 
 
ANNEX 2: STAKEHOLDER CONSULTATION  

The following consultation activities have been performed:  

1.  Social  Partners  Consultation:  as  required  by  the  TFEU  Article  154,  a  formal  two-stage 
consultation of the social partners at EU level is required prior to submitting proposals in the 
social  policy  field.  Such a two-stage  consultation  was  performed in  2020  and  2021. The  first 
phase  of  social  partners’  consultation  closed  on  11  February  2021  with  a  confirmation  of  the 
support for the revision of the current OEL and BLV for led and to propose, for the first time, 
limit values for diisocyanates. The second phase consultation, focused on the envisaged content 
of  possible  proposals,  closed  on  30  September  2021.  More  information  about  this  two-stage 
consultation is provided below in this Annex. 

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

3.  Consultation  of  other  stakeholders  (e.g.,  employers’  and  workers’  associations  specifically 
concerned):  These  consultations  have  been  carried  out  in  the  context  of  the  external  study  in 
order  to collect  detailed  information  on  the  potential impacts  of  establishing  or revising  limit 
values  under  the  CAD  and  CMRD  that  is  not  available  in  published  literature  and  internet 
searches.  

In  line  with  the  previous  amendments  of  the  OSH  Directives  (namely  CMD/CMRD),  no  public 
consultation on this initiative has been launched for the following reasons: 

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

authorities has been carried out in view of this initiative.  

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

 

A call for evidence was published on 21 February 2022 with a deadline of 21 March for stakeholders to 
provide feedback91. 

1.  SOCIAL PARTNERS CONSULTATION  

1.1. 

Results of the first phase of the Social Partners consultation.  

The first phase of the Social Partners consultation closed on 11 February 2021. 

91https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12745-Health-safety-at-work-protecting-
workers-from-exposure-to-chemicals-lead-and-di-isocyanates-_en  

56 

 
 
 
 
                                                      
The Commission consulted the Social Partners on the approach regarding the revision of a limit value 
for  asbestos  under  the  Asbestos  at  Work  Directive,  and  the  establishment  or  revision  of  binding 
occupational exposure limit values for lead and its compounds and diisocyanates under the Chemical 
Agents Directive. 

Workers' organisations  

Two trade unions replied to the first phase consultation, acknowledging the importance of the existing 
legislation. The  European Trade  Union  Confederation  (ETUC)  replied  on  both  the  revision of a limit 
value for asbestos and the establishment or revision of binding occupational exposure limit values for 
lead  and  its  compounds  and  diisocyanates.  The  European  Federation  of  Building  and  Woodworkers 
(EFBWW) replied in detail only concerning asbestos. 

Possible improvements to the EU legal framework 

In  response  to  the  consultation  questions  (1)  Do  you  agree  with  the  issues  identified?  (2)  Are  they 
accurately  and  sufficiently  covered?  (3)  If  so,  do  you  consider  that  the  EU  should  address  this  issue 
through  a  binding  instrument?  ETUC  and  EFBWW  are  of  the  opinion  that  the  EU  must  take  new 
legislative  initiatives  that  are binding  to Member  States.  The  ETUC  gave  detailed  comments  on  each 
substance and EFBWW only on asbestos. 

Lead and its compounds 

ETUC,  while  in  principle  supported  reducing  the  current  limit  values,  expressed  views  that  the 
proposed  BLV  in  the  scientific  opinion  adopted  by  the  Risk  Assessment  Committee  of  the  European 
Chemicals Agency would be discriminatory for women at the workplace92. Instead, they recommended 
the  adoption  of  a  BLV  that  in  their  opinion  would  guarantee  equal  treatment  of  women  and  men  at 
work. 

In  addition,  they  put  forward  some  general  reflections  concerning  the  need  to  improve  workers’ 
protection  from  exposure  to  reprotoxic  substances  and  concerning  the  Pregnant  Workers  Directive 
92/85/EEC93 in this context. 

Diisocyanates   

ETUC supported that a binding EU OEL is needed to ensure minimum requirements for the protection 
of workers exposed to diisocyanates across the EU. At the same time, they expressed the view that this 
is the first time an EU binding OEL would be established for sensitisers with the main aim to prevent 
occupational asthma, and therefore this point should be discussed and agreed upon within the tripartite 
Advisory  Committee  on  Safety  and  Health  at  Work  (ACSH)  where  workers,  employers  and 
governments are represented.  

Willingness to enter into negotiations 

The  workers’  organisations  believe  that  binding  EU  legislative  action  is  needed  on  these  issues  and 
therefore see no need to launch a negotiation procedure pursuant Article 155 TFEU. 

92 RAC recommends to state in the Chemical Agents Directive that the exposure of fertile women to lead should 
be avoided or minimised in the workplace because the BLV for lead is not protective of the offspring of women of 
childbearing age. In ETUC’s view, this is discriminatory as it could create a situation where women could not be 
hired in workplaces where they can be exposed to lead and its compounds.  
93 See footnote 28.  

57 

 
 
                                                      
 
ETUC indicates, however, that it might wish to discuss complementary issues with employers and seek 
convergent positions on certain questions, such as the best legal instrument to protect workers from the 
risk of exposure to substances that are toxic and affect reproduction or the need for a new methodology 
to be used to limit the volume of non-threshold substances at EU level. 

Employers' organisations 

Three  employers'  organisations  replied  to  the  first  phase  consultation:  Business  Europe,  SME  united 
(European Association of Crafts and SMEs) and the European Construction Industry Federation (FIEC).  

The  employers'  organisations  supported the objective to  effectively  protect  workers from  exposure to 
hazardous chemicals, including by setting OELs at EU level, where appropriate. They consider this is in 
the interest of workers and businesses and contributes to a level playing field. However, they also raised 
some concerns about the approach taken when setting such values. 

Possible improvements to the EU legal framework 

Concerning the issues identified in the consultation paper, the employers’ organisations supported the 
general  direction  of  the  Commission  to  a  constant  improvement  of  the  protection  of  workers  from 
exposure  to  carcinogens  and  risks  arising  from  chemical  agents  at  the  workplace,  subject  to  certain 
conditions. The process of setting limit values should be based on sound scientific evidence, technical 
and economic feasibility, socio-economic impact assessment, and opinion of the tripartite ACSH, as it 
is done currently by the Commission.  

Furthermore, they stressed that a lower limit value does not always mean better protection of workers, 
as it depends on the feasibility to measure it and for employers to implement it. 

Business  Europe  and  SME  United  stressed  the  need  to  assess  impact  on  small  and  medium-sized 
enterprises  (SMEs),  in  particular  on  micro-enterprises,  in  terms  of  proportionality  and  feasibility  of 
action, as well as to take account of sectoral differences. 

Concerning the question on the binding instrument to be used for addressing the issues, SME United 
pointed  out  that  without  a  deeper  analysis  of  the  impact  of  the  new  values  on  crafts,  SMEs,  and 
employers’ obligations, they cannot assess whether such an instrument would be appropriate. 

Lead and its compounds 

Business Europe referred to the voluntary agreements put in place by the industry to continuously lower 
the exposure levels, as far as technology allows it. 

They stressed that OSH legislation at EU and national level already provides a good level of protection 
for workers and highlighted the importance of the existing binding OEL under CAD together with other 
protective measures aside from the limit value. 

SME United underlined that a concrete proposal on the new foreseen OEL should be submitted in order 
to better assess the impact on companies. 

Diisocyanates   

SME United is of the view that a detailed analysis of the risks for diisocyanates justifying setting a limit 
value is missing. However, while in principle  they  did not oppose the introduction of a proportionate 
and feasible OEL for diisocyanates in indoor workplaces, for outdoor workplaces they considered that 
training requirements addressing the possible risks and hazards are sufficient. 

58 

 
 
Business  Europe,  although  agreeing  with  the  existence  of  risks  for  workers,  highlighted  that  the 
introduction of a new binding OEL would put additional obligations on employers not only to comply 
with the limit value, but also with the other protective measures in CAD.  

They also stressed the importance of workers’ protection already provided under REACH through the 
restriction, as well as obligations concerning the training of workers. Moreover, they noted that the Risk 
Assessment  Committee  (RAC)  in  the  framework  of  the  restriction  mentioned  that  the  training  of 
workers is the most effective way of reducing exposure and impact on workers. 

Business  Europe  expressed  the  need  for  the  EU  to  provide  more  information  and  analysis  on  how 
effective a binding OEL would be in addition to the existing restriction under REACH. 

Willingness to enter into negotiations 

The employers’ organisations considered that the existing preparatory procedures already involve social 
partners,  including  the  ACSH  consultations.  Therefore,  they  do  not  want  to  launch  a  negotiation 
procedure pursuant Article 155 TFEU. 

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

The  Commission  launched  a  second  phase  consultation  of  the  Social  Partners  which  closed  on  30 
September  2021.  This  second  phase  consultation  focused  on  the  envisaged  content  of  possible 
proposals, as required under the Treaty. 

Workers’ organisations 

The  ETUC  replied  to  the  second  phase  consultation.  They  recognised  the  importance  of  further 
improving  the  protection  of  workers  from  exposure  to  lead  and  diisocyanates  and  support  binding 
action via the revision of the Directives. 

Having already answered the first phase consultation, they reconfirmed their statements. 

They do not see the need to enter negotiations under Article 155 TFEU to make progress on this. 

Employers' organisations 

Business  Europe  and  the  Shipyards’  &  Maritime  Equipment  Association  of  Europe  (SEA  Europe) 
replied to the second phase consultation. 

Business Europe, having already answered the first phase consultation, reconfirmed their statements. 

SEA Europe stated that diisocyanates are rarely used in their industry and if they could be no longer 
used, they would find an alternative substance. 

They  considered  that  the  existing  preparatory  procedures  already  involve  social  partners  and  that  the 
ACSH is the right place for dialogue with social partners, jointly with governments, on the next steps in 
the process. Therefore, they do not want to launch a negotiation procedure pursuant Article 155 TFEU. 

2.  CONSULTATION OF THE ACSH/WPC 

59 

 
 
 
 
The Advisory Committee on  Safety and Health at Work (ACSH) adopted, on 24 November 2021, an 
opinion on lead for an EU binding OEL and a binding BLV under CAD (now CMRD), and an opinion 
on diisocyanates for a binding OEL and STEL under CAD.  

Lead 

Although  there  is  consensus  agreement  on  the  need  to  substantially  revise  downwards  the  existing 
binding OEL set at 0.15mg/m3 and BLV set at 70µg Pb/100ml blood for lead, to better protect workers’ 
health and safety, taking into account scientific and technical developments since the current OEL and 
BLV were first adopted in 1982. No consensus was reached on the limit value to be proposed. Whilst 
the  Governments’  and  Employers’  Interest  Groups  supported  a  BLV  of  15µg/100  ml,  the  Workers’ 
Interest Group favoured a limit value of 4.5µg/100 ml. The differing views are presented below. 

Table 1: Views of the ACSH/WPC per interest group 

OEL LIMIT VALUES 

BIOLOGICAL LIMIT VALUE 

ACSH 
INTEREST 
GROUP 

GIG 

EIG 

mg/m3 
0.031) 

0.051) 

8 hours 

ppm  mg/m3 

Short-term 
ppm 
- 

- 

15 µg Pb/100ml blood 1) 

- 

- 

15 µg Pb/100ml blood 

Transitional 
measures 

Until  5  years  after 
entry  into  force  a 
BLV  of  20  µg 
Pb/100ml applies.  
Sites  engaged  in  the 
lead 
processing  of 
ores 
and 
concentrates 
(’Primary 
Lead 
Producers‘)  receive 
an  extra 
transition 
time  of  3  years  to 
reach the BLV of 15 
µg Pb/100ml blood 

WIG 

0.004 

- 

- 

4.5 µg Pb/100ml blood 

1) Exposure of fertile women to lead should be avoided or minimised in the workplace because the BLV 
for  lead  does  not  protect  offspring  of  women  of  childbearing  age.  The  blood  lead  level  in  women  of 
childbearing age should not exceed the (95 percentile) reference values of the general population not 
occupationally exposed to lead in the respective EU country. Higher blood lead levels are an indicator 
of potentially exceeded occupational exposure and should be followed up by an occupational hygiene 
expert.  When  national  reference  levels  are  not  available, blood lead  levels in  women  of  childbearing 
age  should  not  exceed  the  Biological  Guidance  Value  (BGV)  of  45  μg/L,  the  maximal  European 
reference value. 

Diisocyanates 

There is consensus agreement on the need to adopt a binding OEL and STEL under CAD to be set at: 

Table 2: Consensus of the ACSH/WPC on diisocyanates 

60 

 
 
 
 
 
 
 
 
 
 
OEL LIMIT VALUES 

8 hours 

Short-term 

µg 
NCO/m3 
6 

ppm  µg 

ppm 

NCO/m3 
12 

- 

Notation 

Transitional 
measures 

Dermal and respiratory 
sensitization, Skin 

20  µg  NCO  /m3  as 
STEL  and  10  µg 
NCO  /m3  as  TWA 
till 2029 

NAME OF THE 
CHEMICAL 
AGENT 

Diisocyanates, O 
= C=N-R-N = 
C=O, with R an 
aliphatic or 
aromatic 
hydrocarbon unit 
of unspecified 
length 

3.  CONSULTATION OF OTHER STAKEHOLDERS 

In  the  context  of  the  external  study,  consultation  activities  have  been  carried  out  to  collect  detailed 
information on the potential impacts of modifications to the  CAD and CMRD that is not available in 
published  literature and internet  searches.  Although  some  information  on  OELs,  STELs  and  BLVs  is 
available, limited information is available on the specific concrete risk management measures already in 
place, as well as those that would need to be implemented, should the proposed new and revised limits 
be introduced.  

The  consultation  aimed  at  gathering  primarily  factual  information  (e.g.,  on  the  existing  Risk 
Management  Measures),  which  was  then  used  to  develop  an  accurate  baseline  scenario  and  outline 
preliminary  stakeholder  views  on  the  possible limit values  and  the  consequences  they  could  have  for 
companies, for example, on the initial investment needed and the recurrent costs that could be expected. 
The information sought via consultation covered multiple factors, such as  sizes of companies, sectors 
and  processes  that  would  be  affected,  number  of  workers  exposed,  annual  company  turnover,  the 
specific substances related to their activities and the current air concentrations of substances concerned 
(both  8-hour  time  weighted  averages  (8-h  TWA)  and  15-minutes  reference  periods),  results  of 
biological  monitoring,  risk  management  measures  currently  in  place,  as  well  as  risk  management 
measures that would need to be implemented should the OEL, and BLV for lead be revised and an OEL 
and STEL for diisocyanates be introduced, together with associated costs. The consultation also sought 
companies’ views on hypothetical future limit values, to obtain an anticipated estimate of the cost range 
for any additional Risk Management Measures that would be necessary. Consequently, input from the 
industry strongly fed into the cost calculations.  

The consultation carried out for the purposes of the study consisted of the following main activities: 

  Questionnaires; 
  Email requests (possibly in combination with questionnaires); 
  Telephone interviews; 
  Site visits. 

Mixed methods (combining e.g., questionnaire responses with telephone interviews and site visits) were 
adopted to ensure that a large number of organisations and individuals were able to provide data and 
provide their views within the time constraints and resource limits. Using mixed methods also enabled 

61 

 
 
 
 
 
  
the  study  team  to  gather  varying  details  of  information  and  to  explore  information  further  where  the 
need arose. 

3.1.  Targeted Online Questionnaires 

Stakeholders were initially contacted via email. The e-mail provided an overview of the study and a link 
to the questionnaires. Stakeholders were also able to download a PDF version of the questionnaire via 
the website if they preferred (so that it could be shared among several colleagues, for example). 

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

  Questionnaire  1  was  aimed  at  companies  whose  workers  were  exposed  to  lead  and/or 

diisocyanates; 

  Questionnaire 2 was aimed at occupational health and safety experts; and  
  Questionnaire 3 was aimed at Member State authorities.  

Specific values were established for the purposes of the stakeholder consultation. The specific values 
function as reference points to the consultees, who may otherwise have found it impossible to provide 
data on the costs of the measures being considered.  

The  questions  aimed  to  collect  information  on  processes  during  which  worker  exposure  to  the 
substances in question is likely to occur, risk management measures that are already in place, current 
exposure  concentrations,  risk  management  measures  that  would  need  to  be  implemented  should  the 
limit values for lead be lowered, and limit values for diisocyanates be introduced and any other impacts 
that could result from these new and revised limit values at EU level. 

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

3.2.  Telephone interviews 

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

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

3.3.  Email requests 

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

3.4.  Site visits 

62 

 
 
Companies  whose  activities  are  likely  to  be  affected  by  the  potential  modifications  to  the  CAD  and 
CMRD were also asked whether they would be willing to host a site visit, real or virtual. Companies to 
be  visited  were  identified  via  the  questionnaire,  or  the  contact  was  established  via  EU  trade 
associations. 

The purpose of the site visits was to obtain a detailed operational understanding of the risk management 
measures  that  have  already  been  implemented  to  protect  workers  from  exposure  to  lead  and 
disocyanates, as well as of the risk management measures  that would be needed, and their associated 
costs should the limits be reduced. 

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

Due to the COVID-19 restrictions in place for the duration of the study, fewer physical site visits took 
place than for previous studies. Companies were furthermore reluctant to hold virtual site visits due to 
the confidential nature of the information to be shared. 

3.5.  Stakeholders targeted 

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

Table 3: Stakeholders targeted and interests represented 

Stakeholder type 

EU Associations 

MS Authorities 

Interests represented 

Interest of industry 

Interest of MS authorities 

Manufacturers/users 

Interest of industry 

National industry associations 

Interest of industry 

Trade Unions 

Interest of workers 

Occupational  Health  & 
Professionals 

Safety 

No  particular  interest  -  contacted  in  order  to  obtain 
scientific information 

ACSH  Working  Party  on  Chemicals 
(WPC) 

Laboratories 

Source: External study (RPA 2021) 

Interests of industry, workers and MS authorities 

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

4.  CALL FOR EVIDENCE 

A call for evidence was published on 21 February 2022 with the deadline for comments running until 21 
March 2022. During this period, 38 formal replies were received from a variety of stakeholders and also 
from  an  individual  citizen.  From  the  38  replies,  1  was  disregarded  as  it  did  not  relate  to  lead  and 
diisocyanates. The replies are divided per type of organisation as follows: 

63 

 
 
 
 
Type of organisation 

No. of replies 

Company/Business organisation 

Business Association  

Trade Union 

NGO (Non-governmental organisation) 

Academic/Research Institution 

EU Citizen 

Other 

Grand Total 

13 

12 

5 

2 

1 

1 

3 

37 

In terms of the size of companies, 15 replies arrived from large companies (250 or more employees), 9 
from small and medium companies (less than 250 employees) and 12 from micro companies (less than 
10 employees) together with 1 EU citizen.  

The geographical spread and associated number of replies was PL 9, DE 8, BE 5, SE 4, CZ 3, FR 2 AT 
1, FI 1, RO 1 and from outside EU 3 replies from the UK. 

Feedback  from  trade  unions  reflects  in  principle  the  same  concerns  and  opinions  of  the  workers’ 
organisations as in their reply to the EU social partners’ consultation. Trade unions in general call for a 
lowering  of  the  limit  values  for  lead  and  the  introduction  of  limit  values  for  diisocyanates.  For  lead, 
they expressed concern about the need to protect the unborn foetus and the need to ensure equality of 
treatment of men and women at work. 

Companies’  and  business  organisations’  feedback  is  in  line  with  the  position  of  the  employers’ 
organisations given during the EU social partners’ consultation.  For lead, they recognise that both the 
OEL and BLV are in need of revision. However, the revised limit values need to be proportionate to the 
risk  and  consider  the  socio-economic  impact  and  the  level  of  investment  required.  Given  the  capital 
investment required, a significant transition period may be necessary. For diisocyanates, they generally 
welcome  this  initiative.  There  are  some  varying  replies  as  regards  the  effectiveness  of  the  REACH 
restriction requiring workers to be trained before using diisocyanates. Some replies considered that the 
OSH and REACH initiatives collectively provide a framework that fully protects workers, whilst some 
others were critical of the REACH restriction and preferred regulation only under OSH. 

The  reply  from  academia  supports  the  plans  to  set  EU  limit  values  for  diisocyanates  to  prevent 
occupational asthma. 

The  reply  from  the  citizen  focused  on  the  use  of  lead  in  explosives  and  the  need  to  lower  the  limit 
values whilst ensuring the correct functionality of explosives and not to create regrettable substitution. 

64 

 
 
 
 
 
ANNEX 3: WHO IS AFFECTED AND HOW? 

1. 

PRACTICAL IMPLICATIONS OF THE INITIATIVE 

1.1.  Consumers/Workers 

-  Due to the high degree of competition in the affected sectors, there is a very limited risk of costs 
arising  from  working  under  new  or  stricter limit  values  being  passed  on to citizens/consumers as 
prices; 
increased 

-  Workers will have the duty to comply with the dispositions provided by the employers as regards 
the  use  of  preventive  and  protective  measures  necessary  to  comply  with  OSH  legislation  (e.g., 
revised OEL and BLV for lead and the newly established OEL and STEL for diisocyanates). 

1.2.  Businesses 

Employers: 

-  Must  adjust  the  working  practices  to  comply  with  the  new  and  revised  limit  values,  in  particular 

reinforcing existing risk management measures. 

-  May  find  it  easier  to  recruit  and  retain  staff,  reducing  the  cost  of  recruitment  and  increasing  the 

productivity of workers. 

1.3.  Administrations 

Member States must transpose the amended Directives (CAD & CMRD) into national legislation.  

65 

 
 
 
 
 
 
 
 
 
2.  SUMMARY OF COSTS AND BENEFITS FOR LEAD 

I. Overview of Benefits (total for all provisions) – Preferred Option 
Amount 

Description 

Comments 

Direct benefits 

Savings 
companies 

for 

€5 million 

Savings  for  public 
sector 

€100 million 

Savings 
for 
workers & families 

€160 – 250 million 

payments. 

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

In 
include 

Having  reduced  health  care  costs.  Avoidance 
of  loss  of  productivity  and  mitigation  of 
financial 
loss  of  national  social  security 
systems,  reducing  the  costs  of  healthcare  and 
the  loss  of  tax  revenue  due  to  morbidity  and 
mortality. 

More  effective  protection  of  their  health, 
their 
reducing  suffering  of  workers  and 
families, 
and 
length,  quality 
productivity  of  their  working  lives,  avoiding 
ill-health (including their offspring), less costs 
of informal care. 

increased 

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

II. Overview of costs – Preferred option 

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

Compliance costs   €565 million 

€180 million 

€500,000 

Monitoring costs 

Administrative 
costs 

€0 

€0 

€0 

€0 

€0 

€0 

Costs related to the ‘one in, one out’ approach 

€0 

€0 

€0 

Direct adjustment 
costs  

€565 million 

€180 million 

Total   

Indirect adjustment 
costs 

€0 

€0 

Administrative 
costs (for 
offsetting) 

€0 

€0 

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

66 

 
 
 
 
 
 
 
 
 
 
 
 
 
3.  RELEVANT SUSTAINABLE DEVELOPMENT GOALS FOR LEAD 

III. Overview of relevant Sustainable Development Goals – Preferred Option(s) 
Relevant SDG 

Comments 

Expected  progress  towards  the 
Goal 

The initiative will avoid 
13 379 cases of ill-health 
(including developmental 
toxicity) to occur in the next 
40 years from exposure to 
lead. 

The benefits of healthier staff 
and better working conditions 
will contribute to an easier 
recruitment and retention of 
staff. Workers’ productivity 
will likely also increase, as a 
result of lower absenteeism. 

SDG no. 3 – Good health 
and well-being. Ensure 
healthy lives and promote 
well-being for all at all 
ages 

The initiative will contribute to 
substantially increasing the health 
of the workforce in the European 
Union through the prevention of 
ill-health due to exposure to lead. 

SDG no. 8 - Decent work 
and economic growth. 
Promote sustained, 
inclusive and sustainable 
economic growth, full and 
productive employment 
and decent work for all 

SDG no. 9 - Industry, 
innovation and 
infrastructure. Build 
resilient infrastructure, 
promote inclusive and 
sustainable 
industrialization and 
foster innovation 

SDG no. 12 - Responsible 
production and 
consumption. Ensure 
sustainable consumption 
and production patterns 

Through the lowering of the BLV 
and OEL the initiative will 
contribute directly to a decent work 
environment.  

The initiative will impact 
positively the development of new 
technology as a consequence of the 
need to implement more efficient 
risk management measures to 
comply with the stricter BLV and 
OEL.  

A reduction in exposure to lead is 
expected as a result of risk 
management measures put in place 
to comply with a stricter BLV and 
OEL.  
Thus, the initiative would have a 
limited positive impact, namely on 
the environmentally sound 
management of chemicals and all 
wastes throughout their life cycle. 

4.  SUMMARY OF COSTS AND BENEFITS FOR DIISOCYANATES 

I. Overview of Benefits (total for all provisions) – Preferred Option 
Amount 

Description 

Comments 

Savings 
companies 

for 

€0 

67 

Direct benefits 

payments. 

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

In 
include 

 
 
 
 
 
 
 
 
Savings  for  public 
sector 

€0 

Savings 
for 
workers & families 

€0 

Having  reduced  health  care  costs.  Avoidance 
of  loss  of  productivity  and  mitigation  of 
financial 
loss  of  national  social  security 
systems,  reducing  the  costs  of  healthcare  and 
the  loss  of  tax  revenue  due  to  morbidity  and 
mortality. 

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

increased 

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

II. Overview of costs – Preferred option 

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

Compliance costs  

€14.8 million 

-€4.4 million 

€970,000 

Monitoring costs 

Administrative 
costs 

€0 

€0 

€11 000 
million 

€2 400 million 

€0 

€0 

Costs related to the ‘one in, one out’ approach 

€0 

€0 

€0 

Direct adjustment 
costs  

€14.8 million 

€11 000 
million 

Total   

Indirect adjustment 
costs 

Administrative 
costs (for 
offsetting)94 

€0 

€0 

€0 

€0 

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

5.  RELEVANT SUSTAINABLE DEVELOPMENT GOALS FOR DIISOCYANATES 

III. Overview of relevant Sustainable Development Goals – Preferred Option(s) 
Relevant SDG 

Comments 

Expected  progress  towards  the 
Goal 

SDG no. 3 – Good health 
and well-being. Ensure 
healthy lives and promote 
well-being for all at all 

The initiative will contribute to 
substantially increasing the health 
of the workforce in the European 
Union through the prevention of 

The initiative will avoid 
106 910 cases of asthma and 
10 099 cases of irritation to 
occur in the next 40 years 

94 The above €2.4bn administrative costs are covered by one of the exemptions to the offsetting obligation in the 
context  of  the  ‘one  in,  one  out’  approach  in  line  with  Better  Regulation  Tool  #58  ‘EU  Standard  Cost  Model’ 
(namely, inspections on behalf of public authorities). 

68 

 
 
 
 
 
 
 
 
 
 
 
 
                                                      
ages 

asthma and irritation due to 
exposure to diisocyanates. 

from exposure to 
diisocyanates. 

SDG no. 8 - Decent work 
and economic growth. 
Promote sustained, 
inclusive and sustainable 
economic growth, full and 
productive employment 
and decent work for all 

SDG no. 9 - Industry, 
innovation and 
infrastructure. Build 
resilient infrastructure, 
promote inclusive and 
sustainable 
industrialization and 
foster innovation 

SDG no. 12 - Responsible 
production and 
consumption. Ensure 
sustainable consumption 
and production patterns 

Through the introduction of the 
OEL and STEL the initiative will 
contribute directly to a decent work 
environment.  

The benefits of healthier staff 
and better working conditions 
will contribute to an easier 
recruitment and retention of 
staff. Workers’ productivity 
will likely also increase, as a 
result of lower absenteeism. 

The initiative will impact 
positively the development of new 
technology as a consequence of the 
need to implement more efficient 
risk management measures to 
comply with the OEL and the 
STEL. 

A reduction in exposure to 
diisocyanates is expected as a 
result of risk management 
measures put in place to comply 
with the OEL and the STEL.  
Thus, the initiative would have a 
limited positive impact, namely on 
the environmentally sound 
management of chemicals and all 
wastes throughout their life cycle. 

69 

 
 
 
 
 
 
 
 
 
ANNEX 4: ANALYTICAL METHODS  

The calculations of ill-health cases, and the cost-related calculations are based on a 40-year reference 
period, to take into account the total risk over the working life. This allows to present a long-term view, 
instead of considering only the risks that might manifest at the early stages of exposure. 

4.1 

Estimation and Monetisation of the Health Impacts 

4.1.1  Health impacts 

The  revision  of  the  current  BLV  and  OEL  for  lead  and  new  OEL  and  STEL  for  diisocyanates  is 
expected to result in a reduction of exposure to both substances. The extent of such reduction depends 
on the current levels of exposure, as well as on projected future levels of exposure in the absence of the 
proposed measures, i.e., the baseline scenario. 

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

  ERRs and DRRs for the relevant health effects; 
  numbers of workers exposed; 
 
exposure concentrations (diisocyanates) or blood lead levels (lead); and 
  past and future trends in the exposed workforce and exposure concentrations. 

This methodology section deals with the principles of this estimation procedure.  

The number of workers exposed 

It  is  important  to  calculate  the  number  of  workers  potentially  exposed  to  a  substance  in  order  to 
calculate the potential benefits of implementing any new measures.  

Data on exposed workforce are available from national databases in a number of Member States. The 
data  in  general  include  exposed  workforce  from  activities  subject  to  notification.  This  data  was  then 
extrapolated to the EU27 on a per capita basis. 

4.1.2  Monetisation of the health impacts 

Specific guidance is provided in the Better Regulation (BR) Toolbox for health impacts (BR Tool #32). 
This is summarised in the table below. 

Table 1: Better Regulation Toolbox on health impacts 

Aspect 

Guidance 

70 

 
 
 
 
 
 
 
 
 
Health impacts 

Direct impacts 

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

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

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

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

Source:  External  study.  RPA  (2021)  (Source:  Better  Regulation  (BR)  Toolbox  –  Tool  health  impacts 

(BR Tool #32)) 

  Direct costs: These are the costs of healthcare, in other words, the medical costs associated with 
the  treatment  of  cancer  and  other  costs,  including  non-medical  costs.  Other  direct  costs  may  be 
incurred  by  the  patients  (say,  the  cost  of  transport  to  attend  appointments)  but  also  by  their 
families/friends, for example, through providing unpaid care. 

  Indirect  costs:  These  are  the  monetary  losses  associated  with  the  time  spent  receiving  medical 
care, including productivity losses due to time spent away from work or other usual activities and 
lost productivity due to premature death. Employers might also bear costs indirectly through inter 
alia  loss  of  output;  payments  related  to  sick  leave;  administrative  costs  related  to  a  worker’s 
absence;  additional 
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. 

recruitment  costs; 

  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 costs95 of ill health are measured by the costs borne for health 
care  provision,  together  with  lost  output  (including  productivity  losses),  gross  wage  and  non-wage 
labour  costs  of  absent  workers  (such  as  loss  of  experience),  administrative  costs  and  the  intangible 
costs.  These  represent  the  direct  and  indirect  resource  costs  and  the  non-market  ‘external’  costs  of 
illness. The other costs listed above (e.g,. insurance premiums) relate to what are commonly referred to 
as ‘transfer payments’, which do not give rise to net welfare effects. As a result, they are not considered 
in economic analyses, even though they may be important in financial terms to an individual worker or 
an employer. 

4.1.3  Benefits model 

4.1.3.1  Introduction 

95 From a welfare economic perspective.  

71 

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

Table 2: Key health endpoints 

Substance 

Carcinogenic endpoints 

Non-carcinogenic endpoints 

Diisocyanates 

- 

Asthma 

Irritation 

Lead and its compounds  Central Nervous System (CNS 

Neuropathy 

Cancer) 

Anaemia 

Chronic kidney disease stage 1 

Elevated blood pressure  

Male fertility 

Pre-eclampsia 

Developmental toxicity 

Source: External Study RPA (2021) 

The key model inputs  are used to estimate the number of cases of ill health over the relevant period. 
The exposed workforce is divided into several bands which are characterised by variations in some of 
these  inputs  and  for  which  the  incidence  of  ill  health  is  estimated  separately  and  subsequently 
aggregated into totals for each substance. 

Parameter 

Explanation 

Table 3: Key model inputs 

Exposure-risk/dose-response 
relationship 

Exposure-Risk  Relationship  (ERR)  for  cancer  effects  or  Dose-
Response Relationship (DRR) for non-cancer effects. 

Exposed workforce 

Number of workers exposed. 

Exposure concentration 

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

For STELs: 15-min peak exposure (real concentration after taking into 
account PPE). 

For BLVs: the concentration of the relevant substance or metabolite in 
the relevant biological media such as blood or urine. 

Trends 

Past and future trends in numbers of workers exposed and/or exposure 
concentrations.  

Source: External Study RPA (2021) 

72 

 
 
 
 
In addition to the key inputs set out above, the model relies on a range of assumptions that determine 
when  the  relevant  effect  occurs  or  is  diagnosed,  the  nature  and  severity  of  its  effects,  and  how  long 
these effects (or their consequences) last.  These assumptions differ by substance and health outcome. 
Some of these assumptions are a simplification of complex real-life scenarios or best estimates (where 
authoritative evidence could not be identified from available literature).  

The key areas in which assumptions had to be made to enable the model to estimate and monetise the 
incidence of ill-health over the relevant assessment period are set out below. 

Table 4: Further assumptions and their consequences for the sensitivity analysis  

Parameter 

Explanation 

Onset of the disease 

MinEx 

MaxEx 

Lat 

Dist 

The minimum exposure duration required to develop the endpoint. 

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

The latency with which the effect is demonstrated. 

The distribution of cases over the period between MinEx and the MaxEx: the 
default assumption is a linear accumulation of risk over the relevant period. 

Mortality 

Mortality rate as a result of the relevant condition. 

The effects of the disease 

Severity 

The typical severity (mild to severe) of the relevant outcome – where a range of 
severities is expected, a weighted average has been estimated. 

Value of a case  

Monetary value of a case taking into account the direct, indirect, and intangible 
costs  estimated  relying  either  on  a)  Willingness  to  Pay  (WTP)  for  a  case  of 
mortality  or  morbidity  or  b)  monetised  Disability  Adjusted  Life  Years 
(DALYs). 

Source: External Study RPA (2021) 

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

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

period; 

  the Present Value (PV) of the direct, indirect, and intangible costs of these cases. 

4.1.4  Key model inputs 

4.1.4.1  Rx: estimate of the risk or fraction of workers affected 

The risk of developing the relevant effect is estimated by combining exposure concentrations with: 

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

73 

 
 
 
health endpoint as it occurred in the underlying study and does not provide an indication for progression 
of disease severity. This is taken into account in the course of monetisation of the cases estimated by the 
model.  

For  cancer:  Exposure-Risk  Relationship  (ERR),  i.e.,  excess  risk  of  developing  cancer  due  to  lifetime 
occupational exposure to a substance (40 years). 

4.1.4.2  ExW: exposed workforce 

The sources of data and assumptions used to estimate the numbers of workers exposed to the relevant 
substance are detailed in the substance-specific reports, together with the expected future trends. 

As a default value, it is assumed that there is a staff turnover of 5% per year. The 5% per year is lower 
than the turnover ratios in most of the published literature and Eurostat, which are typically derived at 
the  level  of  individual  companies  rather  than  sectors.  However,  it  is  common  that,  e.g.,  construction 
workers  would  continue  to  work  within  construction  for  a  major  part  of  their  work  life,  but  it  is 
uncertain to what extent they would continue with a job function with a specific exposure situation. 

We consider, in accordance with the assumptions in the previous RPA & COWI studies, that a ratio of 
5% is deemed appropriate to account for the fact that some workers may continue to work in the  same 
sector and continue to be exposed to the same substances. 

4.1.4.3  Cx: Exposure concentrations 

For each substance, one or more exposure scenarios have been modelled based on data sourced from 
literature and consultation – these scenarios are used for the estimation of the costs and benefits (cost 
savings from reduced ill-health) of the OEL and BLV policy options. 

The  number  of  workers  exposed  at  levels  of  relevance  for  the  assessment  of  establishing  an  OEL  is 
derived  from  consultation  with  relevant  companies  and  industry  associations,  databases,  literature, 
workers' associations and other sources. For each of the relevant sectors, distributions of workers over 
exposure  levels  were  established.  In  general,  it  is  assumed  that  the  exposure  concentrations  are 
lognormal distributed, and exposure data collected for this study are fitted to a lognormal distribution 
for  which  the  key  parameters  such  as  the  50th,  75th,  90th  and  95th  percentiles  are  estimated  (please 
note that these parameters may differ between substances).   

4.1.5  Key assumptions 

4.1.5.1  Onset of the disease 

MinEx & MaxEx - The minimum and maximum exposure duration required to develop the endpoint 

No cases arise until the minimum exposure duration required to develop the endpoint (MinEx) has been 
reached.  No  further  increase  in  risk  is  assumed  to  arise  with  increasing  exposure  time  after  the 
expiration of the MaxEx. 

The basis for estimation of MinEx and MaxEx for each of the substances is described in the substance-
specific  reports.  The  default  MinEx  is  two  years  for  cancer,  a  standard  assumption  for  a  chronic 
condition. However, for practical reasons, the risk of developing cancer is assumed by the model to start 
in the first year of exposure and accumulate in a linear fashion up to a full risk estimated on the basis of 
the ERR after 40 years of exposure – this may lead to a slight overestimation of the risk.  The minimum 

74 

 
 
exposure  (MinEx)  periods  in  the  table  below  have  been  derived  using  a  precautionary  approach  that 
maximises worker protection.  

The MaxEx reflects the time needed to reach the maximum risk estimated on the basis of the ERR/DRR 
and exposure concentration or biomonitoring.  MaxEx is either based on the situation in the key studies 
used to derive the DRR (if workers were exposed for ten years in that study, it has been proposed that 
MaxEx is ten years because this was the exposure time leading to the effect size used for the DRR) or 
converted to a full working life (40 years). 

Table 5: Minimum and maximum exposure duration to develop a condition (MinEx and MaxEx) 

Substance 

Endpoint (ERR or DRR)  MinEx (years) 

MaxEx (years) 

Diisocyanates 

Asthma  

1 day (0 years) 

40 

Irritation 

1 day (0 years) 

1 day (0 years) 

Lead 
compounds 

and 

its 

CNS cancer 

2 
(for  practical 
reasons the model 
assumes 0) 

40 

Neuropathy 

1 day (0 years) 

7 

Anaemia 

1 day (0 years) 

10 

Chronic kidney disease 

1 day (0 years) 

5 

Elevated BP 

1 day (0 years) 

10 

Male fertility 

1 day (0 years) 

3 

Pre-eclampsia 

1 day (0 years) 

Developmental toxicity 

1 day (0 years) 

information 
No 
available 
– 
assumed  to  be  1 in 
be 
to 
order 
conservative 

No 
information 
– 
available 
assumed  to  be  1 in 
order 
be 
to 
conservative 

Source: External Study RPA (2021) 

4.1.5.2  The distribution of cases over time 

Valuing  the  cost  of  occupational  illness  involves  applying  discounted  costs  to  future  cases  which 
requires that the estimated cases over the period between MinEx and MaxEx are assigned to specific 
years. 

75 

 
 
 
The distribution of cases between start of exposure and the MaxEx is modelled based on the assumption 
of a linear accumulation of risk over time with the maximum risk being achieved at MaxEx. The risk in 
a given year thus equals Risk=Risk at MaxEx/(MaxEx-MinEx). 

For reasons of simplicity, the following approach is used to distribute the total risk (i.e. not incidence 
since  incidence  is  delayed due  to  latency)  over  the  40  period assessed  in  this study.  As  noted  above, 
although  in  theory  no  risk  arises  until  the  MinEx  of  two  years  has  expired,  for  practical  reasons,  the 
models used for this study adopt a conservative approach and assume that risk arises from Year 1. It is 
assumed  that  the  distribution  is  linear,  i.e.  1/40  of  the  excess  risk  arises  in  Year  1  and  100%  of  the 
excess risk predicted for a specific exposure concentration arises by Year 40. 

4.1.5.3  Latency 

The estimated risk is combined with latency to estimate the specific year of diagnosis of a case. 

For non-cancer endpoints the estimated latency period for the non-cancer endpoints in this study is 0 
years. There is 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. 

For  cancer  endpoints  by  way  of  simplification,  default  latency  values  are  used  unless  more  detailed 
estimates  exist  for  the  specific  substance.    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. 

4.1.6  The effects of the disease 

4.1.6.1  MoR - mortality rate 

Mortality  rate  as  a  result  of  the  relevant  condition  is  important  since  different  monetary  values  are 
applied to mortality and morbidity. The mortality rates used in the model are 0% with the exception of 
lead where 80% for CNS cancer and 1.5% for pre-eclampsia are used. 

4.1.6.2  Treatment period 

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

Table 6: Treatment periods 

Substance 

Diisocyanates 

Endpoint 

Asthma 

Irritation 

Asbestos 

Lung cancer and mesothelioma   

Lead and its compounds 

CNS Cancer 

Neuropathy 

Treatment period (years) 

1 

1 

5 

5 

20 

76 

 
 
 
Substance 

Endpoint 

Anaemia 

Chronic kidney disease stage 1 

Elevated blood pressure 

Male fertility 

Pre-eclampsia 

Developmental toxicity 

Treatment period (years) 

1 

20 

20 

5 

1 

1 

Source: External Study RPA (2021) 

4.1.6.3  Monetary value of the relevant endpoint 

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

Table 7: Benefits framework 

Category 

Cost 

Notes 

Direct 

Healthcare 

treatment, 

Cost  of  medical 
hospitalisation, 
radiation 
chemotherapy/immunotherapy, etc. 

including 
consultations, 
therapy, 

surgery, 

Informal care96 

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

Cost for employers 

Cost 
to  employers  due 
payments and absence from work 

to 

insurance 

Indirect 

Mortality – productivity loss  The  economic  loss  to  society  due  to 

premature death 

Morbidity  – 
days 

lost  working 

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

Intangible 

Approach 1 WTP: Mortality  A monetary value of the impact on quality 

Approach 1 WTP: Morbidity 

of life of affected workers 

96 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 cost savings (benefits) as generated by this study.  

77 

 
 
 
                                                      
Category 

Cost 

Notes 

Approach 
Mortality 

Approach 
Morbidity 

2 

2 

DALY: 

DALY: 

Source: External Study RPA (2021) 

All of the costs in the table above have been quantified to ensure that the study can estimate the impacts 
on  individual  stakeholder  groups.  The  approach  to  the  derivation  of  the  costs  for  each  of  the  cost 
categories above is set out below. 

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

Method 1: Application of WTP values to each case (differentiating between mortality and morbidity); 
and 

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

The only difference between Method 1 and Method 2 is the way in which avoided cases of ill health are 
monetised.  Both methods monetise the same number of avoided cases of ill health. 

4.1.7  Benefits assessment 

4.1.7.1  benefits to workers and 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 of 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.  

4.1.7.2  Benefits to employers 

Introducing limit values has obvious cost savings for workers, namely in terms of their health but also, 
indirectly, on their earnings. Employers will also accrue cost savings from their employees being less at 
risk of occupational illness. Such cost savings include: 

78 

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

losses; 
reduced administrative or legal costs relating to employees who are ill;  
reduced insurance premiums; 
reduced reputational risks; and 
reduced sick leave payments. 

 
 
 
 

4.1.7.3  Benefits to employers and workers – lost earnings and productivity losses 

Individuals  will  incur  costs  associated  with  their  inability  to  work  in  terms  of  a  loss  of  earnings, 
including losses linked to days of treatment as well as days off due to illness.  Luengo-Fernandez et al. 
(2013)97 developed an 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).  

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

4.1.7.4  Benefits for the public sector - cost of healthcare 

The unit costs used for monetisation are summarised below. Please note that some of the costs set out in 
the  preceding  sections  have  been  rounded.  For  the  purposes  of  calculating  the  healthcare  costs  of 
illness, we will make use of the average ‘all cancers’ figure of EUR 6 047 per case of cancer (updated 
to 2021 as approximately EUR 7 200).  

Table 8: Unit costs used for monetisation 

Direct costs 

Indirect costs 

Intangible costs 

Endpoint 

Healthc
are 

Inform
al care 

Costs 
for 
employ
ers 

Mortality 
– 
productiv
ity loss 

Morbid
ity – 
lost 
workin
g days 

Approa
ch 1 
WTP: 
Mortalit
y 

Approa
ch 1 
WTP: 
Morbid
ity 

Asthma 

Irritation 

€30,000 

€0 

€12 000 

€0 

€31 106 

€0 

€32 000 

€500 

€0 

€500 

€0 

€500 

€0 

€500 

Approa
ch 2 
DALY: 
Morbid
ity 

Value of 
a DALY 
€100,00
0 

Value of 
a DALY 
€100,00

97 See  https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70442-X/fulltext  

79 

 
 
                                                      
Direct costs 

Indirect costs 

Intangible costs 

Endpoint 

Healthc
are 

Inform
al care 

Costs 
for 
employ
ers 

Mortality 
– 
productiv
ity loss 

Morbid
ity – 
lost 
workin
g days 

Approa
ch 1 
WTP: 
Mortalit
y 

Approa
ch 1 
WTP: 
Morbid
ity 

CNS 
Cancer 

€7 200 

€3 000 

€12 900 

€5 000 

€5 416 

€4 710 0
00 

€455 00
0 

Neuropathy 

€1 000 

€0 

€0 

€0 

€29 778 

Anaemia 

€4 000 

€0 

€2 400 

€0 

€1 500 

€4 710 0
00 

€107 20
1 

€4 710 0
00 

€5 000 

Chronic 
kidney 
disease 
stage 1 

Elevated 
blood 
pressure 

Male 
fertility 

Pre-
eclampsia 

Developme
ntal toxicity  

€1 400 

€0 

€1 800 

€0 

€29 778 

€4 710 0
00 

€1 000 

€800 

€0 

€1 800 

€0 

€148 89
0 

€4 710 0
00 

€5 000 

€1 400 

€0 

€0 

€0 

€0 

€4 710 0
00 

€5 416 

€7 600 

€900 

€5 500 

€5 000 

€100 

€4 710 0
00 

€5 000 

€0 

€0 

€0 

€0 

€20 300 

€0 

€9 600  
(per lost 
IQ) 

€0 

Approa
ch 2 
DALY: 
Morbid
ity 

0 

Value of 
a DALY 
€100,00
0 

Value of 
a DALY 
€100,00
0 

Value of 
a DALY 
€100,00
0 

Value of 
a DALY 
€100,00
0 

Value of 
a DALY 
€100,00
0 

Value of 
a DALY 
€100,00
0 

Value of 
a DALY 
€100,00
0 

Source: External Study RPA (2021)

80 

 
 
4.2 

COST MODEL 

4.2.1 The Cost Model for Estimating Compliance Costs  

The  cost  framework  used  for  the  assessment  focuses  on  the  general  features  of  the    model  for 
estimating compliance costs for companies for diisocyanates and lead.  

Taking into account the direct and indirect behavioural changes as well as potential ultimate impacts, 
the most relevant impacts were selected on the basis of the following factors: 

  The relevance of the impact within the intervention logic; 
 
 

the absolute magnitude of the expected impacts; 
the relative size of expected impacts for specific stakeholders (such as impacts which may be 
small  in  absolute  terms  but  may  be  particularly  significant  to  specific  types  of  companies, 
regions, sectors, etc.); and 
the importance of the impacts for the Commission’s horizontal objectives and policies. 

 

The table below summarises the impact categories that could be significant and that are thus assessed 
in this report. 

Table 9: Assessment of the most significant economic impact categories 

Impact category 

Key impacts 

•  Will it impose additional adjustment, compliance or transaction costs 

on businesses? 

•  Does it impact on the investment cycle? 
•  Will it entail the withdrawal of certain products from the market? 
•  Will it lead to new or the closing down of businesses? 
•  Are some products or businesses treated differently from others in a 

comparable situation? 

•  Does it affect the nature of information obligations placed on 

businesses? 

•  How will the option affect exports and imports out of and into the 

EU? Will imported products be treated differently to domestic goods? 

•  How will investment flows be affected and the trade in services? 
•  Will the option affect regulatory convergence with third countries? 

Have international standards and common regulatory approaches been 
considered? 

•  Does the option have budgetary consequences for public authorities at 
different levels of government (EU own resources, national, regional, 
local), both immediately and in the long run? 

•  Does it bring additional governmental administrative burden? 
•  Does the option require the creation of new or restructuring of 

existing public authorities? 

•  Does the option affect the prices consumers pay for goods and 

services? 

•  Does it have an impact on the quality or safety of the goods/services 

consumers receive? 

•  Does it affect consumer choice, trust or protection? 

Operating costs and 
conduct of business  

Administrative burdens 
on businesses  

Trade and investment 
flows  

Public authorities  

Consumers and 
households  

81 

 
 
Impact category 

Key impacts 

Specific regions or 
sectors  

•  Does it have an impact on the availability or sustainability of 

consumer goods and services? 

•  Does the option have significant effects on certain sectors? 
•  Will it have a specific impact on certain regions, for instance in terms 

of jobs created or lost? 

•  Is there a single Member State, region or sector which is 
disproportionately affected (so-called “outlier” impact)? 

Source: Better Regulation (BR) Toolbox (BR Tool #19) 

4.2.1  Key features of the compliance cost model 

4.2.1.1  Key factors influencing costs  

The key impact are the compliance costs for industry. These are estimated by means of a compliance 
cost model. This considers the Risk Management Measures (RMMs) currently in place and estimates 
the additional RMMs needed for reducing the air exposure levels from the actual levels to the target 
level. 

The model calculates the costs for a group of similar companies incurred in reducing exposure to a 
target  limit  value  based  on  an  assumed  sequence  of  RMM  implementation  which  is  determined  by 
suitability, effectiveness, and cost. 

The output is the cost of implementing the OEL/BLV split by: 

  Sector; 
 
 

company size: small, medium and large; and  
capital expenditure (one-off) and operating expenditure (recurrent). 

The  model  estimated  the  costs  of  compliance  with  the  different  target  OELs  for  diisocyanates  and 
lead. The key model inputs and assumptions are: 

  OEL/BLV options; 
 
  number  of  small,  medium  and  large  enterprises  at  each  of  the  current  exposure 

assumptions about how compliance with the OEL/BLV is determined; 

 

concentrations; 
estimated  average  number  of  exposed  workers  and  workstations  using  the  substance  in  a 
company; 
  discount rates; 
  Current RMMs; 
  RMM effectiveness; 
 
 

cost of RMMs (one-off and recurring) as well as their average lifespan; and 
suitability of specific RMM types for each of the sector. 

4.2.1.2  Discount rates 

82 

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

4.2.1.3  Current RMMs 

The breakdown of RMMs currently used by the relevant companies, differentiated by enterprise size 
and  sector,  was  estimated  for  each  substance.  The  data  sources  and  methods  of  estimation  are 
described in each of the substance-specific reports. 

The following types of RMM are considered: 

  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. These levels are 
summarised below. 

The model is a simplification of reality and focuses on the primary RMM currently used to control 
exposure. It is recognised that in reality a combination of RMMs may be used by a single company to 
control  exposure.  A  further  simplification  is  that  current  RMMs  are  defined  at  sectoral  rather  than 
company level – all companies in a certain sector are thus assumed to have the same RMMs in place. 
Again,  it  is  recognised  that  this  is  a  simplification  which  may  not  be  the  case  in  real  life. 

83 

 
 
4.2.1.4  How does the estimation model work? 

The  assumptions  on  the  effectiveness  and  suitability  of  individual  RMMs  are  used  to  determine 
whether a specific RMM is suitable to reduce exposure in a specific sector by 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 logic process underpinning each company level decision is illustrated in the figure below. 

Figure 1 

Decision making process in the cost estimation model for diisocyanates and lead 

(estimated for each company) 

Source: External Study RPA (2021) 

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

4.2.1.5  Discontinuations in the cost model 

Where the RMMs considered in the cost model are not sufficiently effective to achieve the reduction 
in  exposure  levels  required  to  comply  with  an  OEL/STEL/BLV  option,  it  is  expected  that  the 
company in question would have to substitute the substance, or where this is not possible, discontinue 
the activities that involve exposure to the substance.  In a worst-case scenario, the company may have 
to shut down. 

The discontinuation of activities by companies is calculated based on the cost of the RMMs in relation 
the turnover  and  profit  margin  for  an  individual  enterprise. The  discontinuation  cost is taken  as the 
loss  of  profit  taken  over  20  years  and  the  average  profit  is  assumed  to  be  10%  of  turnover.  A 
prediction  of  whether  a  company  would  have  to  discontinue  its  operations  is  one  of  the  outcomes 
considered in the cost model, usually the one associated with the highest cost. Therefore, generally, 

84 

 
 
 
 
 
the  model  only  chooses  discontinuation  if  no  RMM  (or  combination  of  RMMs)  can  achieve  the 
required reduction in exposure. The model assumes that small and medium enterprises discontinuing 
the  operations  that  involve  exposure  to  the  relevant  substance  would  result  in  the  entire  company 
going out of business. The logic behind this is that small and medium organisations are more likely to 
experience closure if their sole or main operation becomes unfeasible. In contrast, large companies are 
more  likely  to  discontinue  divisions,  lines  or  specific  operations  which  would  not  result  in  the  full 
closure of the business but the discontinuation of the line/process using the relevant substance.  

If the sector is entirely based on the substance, it is possible that 100% of large companies would also 
be forced to close. In the lead report, the business of the companies in the main sectors (primary and 
secondary lead producers, lead acid battery manufacturers, lead article manufacture) is entirely based 
on lead, meaning that, if they could not meet the relevant BLV/OEL option, the relevant companies 
would shut down. For other sectors with exposure to lead, discontinuation would only apply to certain 
activities or divisions of the company. For example, a glass manufacturer may discontinue production 
of  lead  crystal  glass  tableware  but  continue  to  produce  tableware  of  lead-free  glass.  In  such  cases, 
only the lost profit of the division or activity including lead exposure should be accounted for in the 
calculation  of  discontinuation  costs.  However,  such  granular  data  have  not  been  available,  and  the 
discontinuation  of  certain  divisions  or  activities  is  therefore  not  accounted  for.  This  leads  to  an 
overestimation of the discontinuation costs in the case of lead.  

4.2.1.6  Exposure sampling and analysis  

The  costs  of  monitoring  air  concentrations  (sampling  and  analysis)  are  estimated  separately  to  the 
core model.  

4.3 Methodological limitations 

The  calculations  in  the  report  are  subject  to  certain  methodological  limitations.  Regarding  lead, 
exposure concentrations, the number of workers and their turnover are key determinants of the costs 
and benefits. A sensitivity analysis was performed to simulate two scenarios for each of those three 
factors, one with an increase and one with a decrease. In the case of concentration levels, these were 
calculated  with  a  5%  increase  and  a  5%  decrease,  while  for  the  number  of  exposed  workers  each 
scenario  corresponded  to  a  50%  increase  or  decrease.  To  include  the  turnover  in  the  sensitivity 
analysis, a doubling of the annual rate from 5% to 10%, resulting in a turnover of workers of 100% in 
10 years was used for the increased scenario, while for the decreased scenario a halving of the annual 
rate (from 5% to 2.5%, resulting in a 100% turnover of workers over 40 years), was used. In general, 
costs-benefit ratios did not change significantly for the two first. Only in the case of worker turnover 
(as it affects only the calculation of the benefits) did the ratio improve (higher turnover) or decreased 
(lower turnover) more significantly. Besides, a discount rate was factored in the calculations; namely, 
a  declining  discount  rate  of  4%  over  the  first  20  years  and  of  3%  in  the  last  20  years.  The  results 
showed that costs and benefits are mainly equally distributed over time. 

For diisocyanates, the main methodological limitation impacting the robustness of projections is the 
lack of scientific data to assess the health benefits of the different options. Whilst peak exposures are 
particularly important in the development of occupational asthma, related ill-health cases could not be 
modelled  due  to  a  lack  of  data  on  short-term  exposures  (see  section  5.4.2).  This  results  in  an 
underestimation  of  the  costs  and  a  significant  underestimation  of  the  benefits  (asthma  accounts  for 

85 

 
 
more  than  90%  of  the  future  disease  burden)  and  the  impossibility  to  calculate  the  impact  of  the 
different  STEL  options  in  terms  of  ill-health  cases  avoided.  Consequently,  it  does  not  allow  for  a 
purely quantitative comparison of the options.   

Although no sensitivity analysis could be performed to factor in the uncertainties related to short-term 
exposure, a sensitivity analysis was  indeed performed for diisocyanates accounting for a number of 
factors.  Where  exposure  levels  are  below  the  limit  of  quantification,  a  default  value  of  0.25  µg 
NCO/m3 is assigned and then further reduced by 50% to 0.125 µg NCO/m3 to take account of the 
REACH  Restriction. Then,  levels  were  reduced  through  a  given  set  of  values,  and  percentiles  were 
calculated  using  a  log  normal  distribution.  Finally,  all  exposure  levels  were  reduced  by  50%  to 
account for the impacts of the REACH restriction.  

When  considering  the  assumed  impacts  of  the  REACH  restriction,  however,  due  to  the  difficulties 
regarding the calculation of the benefits, the sensitivity analysis performed is less straightforward than 
in the case of lead. The sensitivity analysis considered also a reduction in exposure concentrations of 
30% and 70% in addition to the retained assumption (50%). A sensitivity analysis was also performed 
by  removing  micro  enterprises  (those  with  between  one  and  nine  employees)  in  construction  and 
vehicle  repairs  from  calculations  of  monitoring  and  administrative  costs.  Many  of  these  companies 
employ one person, and data on micro enterprises in construction is difficult to obtain, given the high 
numbers of self-employed. Since it is likely that many of these companies would not be required to 
monitor  compliance  (if  it  can  be  proven  by  other  means),  including  them  in  the  calculations  could 
result in an overestimation of the costs. This results in unchanged benefits but improved cost-benefit 
ratios.  

86 

 
 
 
 
 
 
ANNEX 5: RELEVANT SECTORS, USES AND EXISTING LIMIT VALUES 

5.1 Lead 

5.1.1  Mining and manufacture of lead  

Mining of lead ore takes place in eight Member States as shown in the table below. According to the 
Euromines (2020), the total lead content of the mined ores increased from 197 000 tonnes in 2008 to 
282 000  tonnes  in  2018.  The  two  main  mining  countries  are  Sweden  and  Poland.  There  are  seven 
active lead mines in Sweden, while in Poland exploitation is currently carried out from three deposits 
(ECHA, 2019). 

The total refined lead production in the EU is about 2.7 million t/year, meaning that the mining within 
the EU in 2018 only accounts for about 10%. The remaining ca. 90% of lead concentrate used for the 
primary production of lead was imported from countries outside the EU.  

The production of refined lead is distributed all over the EU and refining takes place in 18  Member 
States. The major Member States in terms of production of refined lead are Germany (24.2% of total), 
Spain (9.8%), Italy (9.5%), Poland (8.8%), and Belgium (7.9%). These figures are from 2014, where 
the UK contributed with 15.8% of the EU refined lead production. The balance between primary and 
secondary production has shifted since 1998, and in 2011 secondary sources accounted for more than 
77% of EU production (BREF, 2017). Lead-acid batteries are the main source of scrap for secondary 
refining. 

The distribution of lead mining and refined lead production (primary and secondary) can be used as a 
rough indication of the distribution of workers exposed to lead within these sectors.  

Table 1: Mining production and production of refined lead (primary and secondary) by 
Member State in EU-27 (from 2020) 

Mining 
production 
2018, t/year* 

Mining 
production 
2008, t/year* 

in 

- 

- 

in 

- 

- 

14 600 

24 200 

- 

- 

- 

- 

16 100 

50 300 

- 

- 

- 

- 

- 

15 300 

16 700 

- 

Austria 

Belgium 

Bulgaria 

Czechia  

Estonia 

France 

Germany 

Greece 

Ireland,  Rep. 
of 

Italy 

Production 
of 
refined  lead  in 
2014, t/year** 

Percentage 
of 
total  production 
of refined lead 

37 122 

133 252 

92 000 

44 000 

8 588 

72 000 

408 000 

6 000 

17 200 

160 000 

2.6% 

9.4% 

6.5% 

3.1% 

0.6% 

5.1% 

28.7% 

0.4% 

1.2% 

11.3% 

87 

 
 
 
 
Mining 
production 
2008, t/year* 

in 

- 

Mining 
production 
2018, t/year* 

in 

- 

47 900 

40 200 

of 
Production 
refined  lead  in 
2014, t/year** 

of 
Percentage 
total  production 
of refined lead 

- 

- 

- 

1 800 

2 400 

63 500 

196 600 

- 

- 

- 

100 

20 300 

64 800 

31 000 

149 000 

5 000 

12 000 

11 000 

- 

166 000 

68 708 

2.2% 

10.5% 

0.4% 

0.8% 

0.8% 

- 

11.7% 

4.8% 

100% 

Netherlands 

Poland 

Portugal 

Romania 

Slovenia 

Slovakia 

Spain 

Sweden 

Total 

181 600 

1 420 870 

(2020)  at:  http://www.euromines.org/mining-europe/production-

Source:  Euromines 

* 
mineral#Lead. Rounded figures. 
** 
publication is the most recent Minerals Yearbook for lead.  

Source: USGS, 2017. Mining production expressed as lead content of concentrate. The 2017 

5.1.2   Primary production of lead 

The production rate of lead and its compounds in the EU is in excess of 10 million tonnes per year. 
Occupational exposure of workers happens primarily in industries that produce or recycle lead or use 
large quantities of lead or lead compounds (such as lead battery production). Exposure also occurs in 
the ceramics and lead crystal glass sectors and PVC processing98. 

Lead is registered under REACH in the tonnage band 1 000 000 – 10 000 000 tonnes per annum. Its 
registered uses are:  

  Lead battery production;  
  lead sheet production; 
  lead powder production:  
  use of lead metal in the production of a range of lead articles (e.g., cast, rolled and extruded 

products, ammunition, lead shot):  

  use of lead metal in the production of leaded steels;  
  use of lead metal in lead oxide production and use of lead oxide in stabiliser production; 

5.1.3 

Secondary production of lead 

The  complex  waste  products  used  for  the  production  of  secondary  lead  may  provide  indications  of 
processes, where exposure to lead can occur when generating the wastes. The substances listed in the 

98 SUBSPORT Specific Substances Alternatives Assessment – Lead and its inorganic compounds, March 2013 
https://www.subsportplus.eu/subsportplus/_Downloads/SUBSPORT-
at 
accessed 
Lead.pdf?__blob=publicationFile on 19 January 2021. 

88 

 
 
 
 
                                                      
following table account for 97.5% of REACH registered tonnage used in the secondary manufacture 
of lead (ECHA, 2019). 

Table 2: Substances used in the secondary manufacture of lead (ECHA, 2019) 

EC 
number 

Name 

Description 

266-970-4 

Slags,  copper 
refining 

266-967-8  Matte, copper 

273-760-6 

273-825-9 

293-314-4 

Flue 
zinc-refining 

dust, 

Slags, 
smelting 

lead 

Leach 
residues,  zinc 
ore, 
lead-
contg. 

308-011-5  Lead, bullion 

305-445-7 

273-809-1 

lead 

Wastes, 
battery 
reprocessing 
Flue 
lead-refining 

dust, 

305-411-1 

Calcines,  lead-
zinc ore conc. 

273-800-2 

lead 

Slags, 
reverbatory 
smelting 

282-356-9  Matte, lead 

Mainly  copper,  copper  oxides,  some  oxides  of  lead  and  minor 
metals,  skimmed  from  the  anode  furnace  and  returned  to  the 
converter. 
Product  of  smelting  roaster  calcines  concentrates  or  cement 
copper with flux in reverberatory or electric furnaces. Composed 
primarily of copper and copper, iron and lead sulfides with minor 
sulfides of other metals. 
By-product  of  refining  of  zinc  ores  consisting  primarily  of  zinc, 
lead and iron. 
Insoluble  substance  obtained  during  dissolution  of  zinc  ores  or 
concentrate  in  sulfuric  acid  for  the  production  of  zinc  sulfate 
solutions after physical separation such as flotation and filtration. 

Insoluble  substance  obtained  during  dissolution  of  zinc  ores  or 
concentrate  in  sulfuric  acid  for  the  production  of  zinc  sulfate 
solutions after physical separation such as flotation and filtration. 

nan 
Material  obtained  during  the  recycling  of  exhausted  lead  storage 
batteries.  Consists  primarily  of  oxides  and  sulfates  of  lead  and 
lead alloys. 
By-product  of  refining  lead  ores  obtained  from  baghouse  and 
electro-static precipitator and as slurry from scrubbers. 
A thermally agglomerated substance formed by heating a mixture 
of  metal  sulfide  concentrates,  limestone,  sand,  furnace  dross, 
miscellaneous  zinc,  lead  and  copper  bearing  materials,  together 
with already roasted material to a temperature of 1000°C  
to 1200°C (538°F to 649°F). 
By-product  from  the  smelting  of  lead  ores,  scrap  lead  or  lead 
smelter  dross.  Consists  primarily  of  oxides  and  silicates  of 
antimony and lead. 
Substance  resulting  from  the  smelting  of  lead  and  its  alloys 
obtained  from  primary  and  secondary  sources  and  including 
recycled plant intermediates. Composed primarily of iron and lead 
(mainly  in  sulfide  form)  and  may  contain  other  residual  non-
ferrous metals and their compounds. 
nan 

273-796-2  Lead, dross 
Note:  The  table  combines  information  from  Table  18  (EC  number  and  name)  and  Table  40 
(description). "Nan" is not explained in the report (ECHA, 2019). 

89 

 
 
 
 
 
 
5.1.4  Consumption of lead 

“First application” is defined as the first application after refining for which a metal is used. As an 
example,  the first  application  may  be  the  manufacture  of  lead  compounds,  which  are later  used  for 
various applications such as manufacturing plastics, paints or ceramics. From 2000 to 2015, the trends 
in the consumption of lead by first applications are shown in the table. The data for 2000, 2005 and 
2015 have been obtained from the Lead REACH Consortium (2019) and represent 14 Member States 
and Norway. The 2015 data represent 94% of the total use of lead for first use in EU28 and EFTA 
countries. The data include consumption volumes from the UK. The breakdown of data per Member 
State is not available, the data have therefore not been recalculated to reflect the EU-27 as per 2020. 
The percentage may be lower or higher for individual applications.  

For 2000, also the data from the Voluntary Risk Assessment for Lead are shown (LDAI, 2008). The 
data  represent  first  applications  in  the  EU15.  In  2000,  lead  additives  for  gasoline,  which  are 
organolead compounds, accounted for about 1% of the total use of lead. The gasoline additives for the 
2005 and 2015 datasets are included under lead compounds.  

Table 3: Consumption of lead by first use application 

19 

971 

1 033 

1 009 

200 
50 
13 

205 
53 
17 

242 
57 
31 

2000**  2000* 

%  of  total 
in 2015 

53% 
30% 
6% 
4% 
1% 

2015* 
809 
460 
95 
57 
18 

Consumption of lead for first use 
(1000 tonnes) 
2005* 

Application 
area  
(sector  numbering  according  to  this 
study) 
Batteries, automotive (3) 
Batteries, industry (3) 
Rolled and extruded products (4) 
Shot and ammunition (4) 
Cable sheathing (4) 
Gasoline  additives  [out  of  scope  of 
study]*** 
Pigments  and  other  lead  compounds*** 
(6) 
Miscellaneous 
solders) (4, 5) 
Total 
* Data from Lead REACH Consortium (2019). Data represent the first applications consumption in 
14 EU Member States and Norway99. The total represents about 94% of the total use of lead for first 
use in EU28 and EFTA countries. Consumption volumes have not been adjusted to reflect the EU-27 
(2020),  as  national  data  for  the  UK  is  not  available.  The  percentage  may  be  different  for  the 
individual applications. The total is similar to the total indicated in the proposal for identifying lead 
as a SVHC (Substance of Very High Concern) (Swedish Chemicals Agency, 2018) but the distribution 
between applications is slightly different. 
**Data  from  the  voluntary  risk  assessment  for  lead  (LDAI,  2008).  Represents  the  consumption  in 
EU15.  
*** Consumption of lead compounds are not differentiated into applications for gasoline additives, 
pigments and other for 2000 -2015 in the data from Lead REACH Consortium (2019). However, the 

(including  alloys  and 

1 677  1 515 

100% 

1 517 

1 458 

201 

110 

202 

4% 

1% 

10 

68 

67 

78 

52 

99  Austria,  Belgium,  Bulgaria,  Czechia,  Denmark,  Finland,  France,  Germany,  Italy,  the  Netherlands,  Norway, 
Poland, Spain, Sweden, the United Kingdom. 

90 

 
 
                                                      
use  of  lead  compounds  as  gasoline  additives  is  restricted  to  diminishing  amounts  in  special 
applications. 

The  consumption  for  batteries  has  been  increasing  during  the  period,  whereas  the  consumption  for 
rolled and extruded products has been decreasing.  

The  decrease  in  the  consumption  of  lead  for  the  latter  three  application  areas  may  be  used  as  an 
indication  of  a  decrease  in  the  number  of  workers  exposed  when  working  with  the  lead-containing 
products  (the  decrease  in  the  number  of  workers  may  be  even  higher  than  the  decrease  in  the  lead 
consumption). 

The following includes a short description of the uses of lead metal.  

Rolled and extruded products. These products consist of lead plates, sheets, strips, bars, wires and 
tubing produced through a combination of rolling, drawing and extruding. Lead sheet accounts for the 
majority of lead used in this category and 85% of lead sheet is used in construction applications, with 
the  remainder  used  in  various  medical,  nuclear,  defence  and  industrial  applications  (Lead  REACH 
Consortium, 2019). Due to differences in architectural style and building techniques, the use of lead 
sheet varies considerably among Member States. During the period 2005-2015, the UK has accounted 
for approximately half of the use of lead in rolled and extruded products. This is of importance for the 
interpretation of data on the number of exposed workers related to the building sector.  

Shot and ammunition. The consumption of lead for the production of ammunition has been stable 
during  2000-2015  (Lead  shot  accounts  for  an  estimated  75%  of  the  lead  used  in  non-military 
shot/ammunition,  while  lead  pellets  and  bullets  account  for  the  remaining  25%  (Lead  REACH 
Consortium,  2019).  Major  civilian  ammunition  manufacture  in  Europe  is  concentrated  in  Italy, 
followed by Germany, Spain, the UK, Sweden, Czechia and France.  

Miscellaneous. Lead is used as an alloying additive to other metals, typically to improve castability, 
finishing and plating characteristics. Lead is used as an alloying element for tin, steel, copper (brasses 
and  bronzes)  and  aluminium  alloys.  The  total  consumption  for  miscellaneous  applications  has 
decreased  markedly  from  67 000  t/year  in  2000  to  10 000  t/year  in  2015.  Lead  was  widely  used  in 
white  metal  and  pewter  (tin-lead  alloys)  models,  ornaments  and  jewellery.  Lead  solders,  the  alloys 
used to create metallurgical bonds between two or more metal surfaces to achieve an electrical and/or 
physical  connection,  once  dominated  both  electronic  and  industrial  applications.  The  use  of  lead 
solders  in  electrical  and  electronic  equipment  (EEE)  has  been  banned  since  2006,  with  some 
exemptions, but the exemptions gradually expire and are often not renewed. According to the Lead 
REACH  Consortium  (2019),  there  is  also  a  move  away  from  the  use  of  lead  solder  in  industrial 
applications, such as in the joins to copper or brass heat exchangers and the solder for joining copper, 
brass and zinc in roofing, and rainwater furniture.  

5.1.5 

 Consumption of lead compounds 

The main uses are described below: 

Batteries.  Lead-acid  battery  manufacture  is  the  largest  application  for  lead  and  lead  compounds  in 
Europe:  lead  oxides  are  pressed,  cured,  hydrated  and  then  reacted  with  sulphuric  acid  to  produce 
porous metallic lead negative electrode pastes (Lead REACH Consortium, 2019). Lead sulphates can 
be used as seeding material for the lead dioxide, the active material at the positive electrode. Lead-
acid batteries are the leading rechargeable battery technology, at over 90% of the rechargeable battery 
market in terms of energy stored. Key countries for lead-based battery manufacture in Europe include 

91 

 
 
Czechia, France, Germany, Italy, Spain, Poland and the United Kingdom (ECHA, 2019). About 99% 
of lead monooxide tonnage used in the EU (500 000 tonnes) and about 80% of lead tetraoxide tonnage 
(36 000  tonnes)  is  used  in  battery  manufacture.  They  are  transformed  in  the  course  of  the  battery 
manufacturing  process  into  pentalead  tetraoxide  sulphate  and  tetralead  trioxide  sulphate,  which  are 
themselves ultimately transformed within the battery into lead metal and lead dioxide (ECHA, 2019). 

Plastic stabilisers. Lead stabilisers based on lead sulphates, phthalates and stearates have traditionally 
been added to both rigid and flexible PVC to improve their physical properties and durability. As of 
the end of 2015 under the VinylPlus voluntary commitment, all lead-based PVC stabilisers have been 
completely  replaced  in  formulations  for  PVC  applications  sold  in  the  EU28.  The  alternatives  are 
predominantly  calcium-based  stabilisers.  In  2005,  approximately  60 000  tonnes  lead  were  used  for 
PVC stabilisers in the EU15. The consumption has gradually decreased from 2005 to 2015. Although 
lead stabilisers are no longer used in virgin PVC in the EU28, some lead stabilisers are still produced 
in Europe for export to other regions. According to the Annex to the Restriction on the use of lead 
compounds to stabilise PVC (ECHA, 2018), the European Stabiliser Producers Association (ESPA) 
representing  more  than  95%  of  PVC  stabiliser  industry  across  EU  indicated  that  in  2016  there  was 
only  one  European  company  producing  lead  stabilisers  for  export  to  non-EU  countries.  The  Annex 
also  notes  that  approximately  30%  of  EU-produced  lead  stabilisers  are  exported  outside  the  EU, 
which means that 70% remains within the EU. According to the proposed REACH restriction of the 
use of lead stabiliser, PVC with lead stabilisers may still be recycled for certain uses.  

Pigments. The major lead pigments are lead chromates, which are subject to authorisation (due to the 
content of hexavalent chromium in the compounds). The total authorised quantities are 3 000 t/year. 
According to the Lead REACH Consortium (2019), pigments based on lead carbonates (white) and 
lead  oxide  (red)  are  used  now  only  in  niche  applications  such  as  paint  for  restoring  or  maintaining 
works of art or historic buildings. For the vast majority of uses in the EU, lead pigments have been 
replaced  with  other  pigments  such  as  titanium  dioxide.  For  red  lead  oxide,  there  is  only  one 
professional use of the substance in paints included in the joint registration dossier, which is for rust-
inhibiting priming paints applied directly to iron and steel (mainly ships) because of its anti-corrosion 
properties.  

Glasses. Leaded glass typically contains 54-65% of SiO2, 24-30% PbO (lead oxide), 13-15% Na2O or 
K2O  and  various  minor  components  (Lead  REACH  Consortium,  2019).  Leaded  glass  has  a  higher 
density and refractive index than most other glasses and is used in decorative applications e.g. wine 
glasses, tableware and decanters. Lead crystal production has historically been concentrated in Europe 
and  has  declined  steeply  over  the last  decade (Lead REACH  Consortium,  2019).  France,  Germany, 
Ireland,  Czechia  and  Slovakia  still  have  some  lead  glass  production  remaining  and  the  lead  use  in 
crystal  glass  in  European  countries  has  been  estimated  at  3 000  –  5 000  t/year  (Lead  REACH 
Consortium, 2019). In the EU, only glass products containing at least 24% of PbO may be referred to 
as  "lead  crystal".  Products  with  less  lead  oxide  must  be  labelled  "crystalline"  or  "crystal  glass" 
(ECHA, 2019). 

Lead  glass  is  also  used  for  various  types  of  optical  and  filter  glasses  e.g.,  camera  and  microscope 
lenses.  Lead  glass  has  been  granted  an  exemption  under  the  RoHS  (Restriction  of  Hazardous 
Substances) Directive (Directive 2011/65/EU) until 2021.  

Frits (ceramics). Frits, a term for the coloured precursors to ceramic glazes and glass colouring, can 
contain  lead  compounds.  Overall,  the  use  of  lead  in  frits  and  pigments  is  decreasing  due  to  the 
availability  of  lead-free  alternatives  and  the  costs  associated  with  ensuring  regulatory  compliance 
when using lead-containing compounds in a workplace (Lead REACH Consortium, 2019). 

92 

 
5.1.6 Biological limit values 

Table 4: Biological limit values in EU Member States and selected non-EU countries for lead 
(status: 28.06.2021) 

Country 

Austria 

Lead 
in 
blood  μg 
Pb/100 
ml 

70  

45  

Specification 

Country 

Lead  in  blood 
μg Pb/100 ml 

Specification 

-men, women 
>50 years 

-women <50 
years 

Portugal 

70  

Belgium 

70  

Romania 

70  

Bulgaria 

Croatia 

40  

30  

40 

30 

-women 
years 

-women 
years 

Slovakia 

<45 

Slovenia 

<45 

Cyprus 

70  

Spain 

Czechia 

40 

Sweden 

40 

10 

40 

30 

70 

31.1(<1.5 
μmol/l) 

10.4(<0.5 
μmol/l 

Denmark 

20  

Estonia 

- 

Finland 

France 

29 
(1.4 
µmol/l) 

40 

30 

-male 

-female 

European 
Union 

RAC 

Australia 

70  

15 

4.5  

30 

-health 
surveillance  for 
workers at > 40 
μg/100 ml 

-women 
years 

<45 

-women 
years 

<45 

-mandatory 
health 
surveillance  for 
workers at > 40 
μg/100 ml 
-men, women 
>50 years 

-women <50 
years  

-mandatory 
health 
surveillance  for 
workers at > 40 
μg/100 ml 
-for lead and its 
inorganic 
compounds 

-women of 
childbearing 
age  
-men 
and 
women  not  of 
reproductive 

93 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Country 

in 
Lead 
blood  μg 
Pb/100 
ml 

18 

Specification 

Country 

Lead  in  blood 
μg Pb/100 ml 

Specification 

10 

capacity 

-recommended 
value 
ANSES 

by 

Germany 

15 

Brazil 

- 

Greece 

70  

Japan - JSOH 

15 

Hungary 

30  
(1.5 
µmol/l) 

20  
(1.0 
µmol/l) 

Ireland 

70 

Italy 

60  

40  

Latvia 

60  

Lithuania 

70  

Luxembourg  70  

Malta 
Netherlands 
Poland 

70  
60  
50  

-men,  women 
>45 years 

-women 
years 

<45 

-health 
surveillance  for 
workers  at  >  40 
μg/100 ml 
-health 
surveillance  for 
workers  at  >  40 
μg/100 ml 

-women 
at 
childbearing age 

-health 
surveillance  for 
workers  at  >  40 
μg/100 ml 

Norway 

0.5 µmol/l 

1.5 µmol/l 

Russia 

- 

South Korea 

- 

Switzerland 

Turkey 

United 
Kingdom 

USA, ACGIH 
USA, NIOS 
USA, OSHA 

40 

10 

70  

60  

30  

20 
60 
50 

of 

-women 
reproductive 
capacity 

-except 
compounds 

alkyl 

-women of 
childbearing 
age 

other workers 

-men,  women 
>45 years 

-women 
years 

<45 

-men 

of 

-women 
reproductive 
capacity 

Table 5: OELs in EU Member States and selected non-EU countries for lead (status: 28.06.20) 

Country  

OEL  [mg/m³, 
(ppm)]  

Specification 

Country  

OEL  [mg/m³, 
(ppm)]  

Specification  

94 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Austria 

0.1 (I) 

Belgium 
Bulgaria 
Croatia 

0.15 
0.05 
0,15† 

Cyprus 
Czech 
Republic 

0.05 

Slovakia 

0.5 (R) 
0.15 (I) 

lead 

alkyl 

for 
compounds 
except 
lead 
compounds; 
R1, L 

Slovenia 
Spain 
Sweden 

0.1 (I) 
0.15 (I) 
(I) 
0.05 (R) 

R1 
R1 
R 

lead 

except 
chloride 
fluoride 
iodide; R1 

EU 
Australia 

0.15(I)† 
0.05 

Dusts 
fumes 

and 

lead 

alkyl 

for 
compounds 
except 
lead 
compounds  

Denmark 
Estonia 

0.05 (I)†  
(T) 
0.05 (R) 

R 
R 

Brazil 
Canada, 
Ontario 

0.1 
0.05 

Finland 

0.1 † 

France 

0.1 (I) 

Germany 

0.15 (I) † 

Greece 
Hungary 

0.1 

0.10  
0.05 (R)  

restrictive 
statutory  limit 
value; K, R 
R1, L  

reference 
value*; R1, L 

Canada, 
Quebec 
China 

0.05 

0.05 (I) 
0.03 (R) 

India 

0.15 

Japan 
Japan JSOH 

0.05 
0.03 

Ireland 

0.15† 

R1 

Norway 

0.05† 

Italy 
Latvia  
Lithuania 

0.15 
0.05 
0.15 (I) 

Russia 
South Korea 
lead  Switzerland 

0.05 
0.05 
0.1 (I) 

except 

95 

and 

leemental, 
inorganic 
organic 
compounds  of 
lead, 
except 
tetraethyl lead 
K 

Dusts 
fumes 

and 

lead 

alkyl 

for 
compounds 
except 
lead 
compounds;  K, 
R1  
and 
dusts 
fumes;  except 
lead 
acetate, 
lead  phosphate, 
lead  chromate 
and 
lead 
subacetate; R 
aerosol 
K, R1 
except 

alkyl 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
lead 
compounds; 
K2,R1  

alkyl 

except 
lead 
compounds 
K 

0.07 (R) 

Luxembourg 
Malta 

0.15 
0.15† 

Netherlands 
Poland 

0.15 (I)† 
0.05 (I) 

sulphide; R  

except 
sulphide; R 

lead 

lead 
except 
arsenate 
and 
lead chromate  

Portugal 
Romania 
JSOH = Japan Society for Occupational Health  

0.15 
0.15 

Turkey 
United 
Kingdom 

0.15 
0.15 

USA, ACGIH  0.05 
USA, NIOSH  0.05(T) 

USA, OSHA 

0.05 (T) 

ACGIH = American Conference of Governmental Industrial Hygienists  

OSHA = Occupational Safety and Health Administration  

NIOSH = National Institute for Occupational Safety and Health  

(I) = inhalable fraction/aerosol  

(R) = respirable fraction/aerosol  

(T) = total dust  

K = carcinogenicity notation assigned 

K1 = assigned as Carc. Category 1A or 1B 

K2 = assigned as Carc. Category  

R = notation as reproductive toxin assigned  

R1 = assigned as Repr. Category 1A or 1B  

L = notation for effects on or via lactation assigned  

* reference value that represents the state of the art. Individual measures are related to this limit value. 
† binding limit value, if explicitly stated by the member state  

**NIOSH indicates a time-weighted average concentration for up to a 10-hour workday during a 40-
hour workweek. 

5.2 

Diisocyanates 

5.2.1  Overview of uses 

Diisocyanates are important industrial chemicals that have several applications; these can primarily be 
categorised as:  

96 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
•  Polyurethane; 

•  CASE: 

-  Coatings (surface treatment like paints and lacquers); 

-  Adhesives; 

- 

Sealants (e.g., fillers/joint fillers); and 

-  Elastomers (e.g., rubber and thermoplastic elastomers). 

The use of diisocyanates consists of manufacturing and professional uses. 

Diisocyanates are used as a raw material in the production of all polyurethane products.  Polyurethane 
foams  (flexible and rigid) are  strong,  durable, resistant  to abrasion,  resistant to corrosion,  have  low 
thermal  conductivity,  and  easily  fill  voids,  and  can  be  shaped.  Combined,  these  properties  make 
polyurethane foams  ideal  for  use in  insulated  building  panels,  mattresses,  upholstered  furniture,  car 
seats, domestic refrigerators, freezers, composite wood panels, truck bodies and footwear. 

Diisocyanates  may  be  present  at  concentrations  of  between  0-50%  in  coatings/paint  products  and 
0.01-90% in adhesive and sealant products (Danish Environmental Protection Agency, 2014). CASE 
products are widely used and occupational exposure may occur during both the manufacturing of the 
relevant  products  as  well  as  professional  use.  This  includes  settings  such  as  construction, 
manufacturing of electrical and related equipment, manufacturing of shoes and textiles, manufacturing 
of wood, transport and machinery manufacturing, and the repair of transport and machinery. 

PMDI  is  used  to  produce  both  flexible  and  rigid  foams  (typically  rigid  foam  is  used  in  metal 
insulation).  insulation  boards  and  cool  chain  applications  (fixed  and  mobile  refrigeration  and 
freezers). Flexible foam manufacturing is the largest consumer of TDI by volume and second largest 
consumer of MDI. The largest consumer of MDI is the rigid foam sector (in the form of pMDI) and 
the elastomer sector. CASE products typically contain MDI, HDI or TDI. The table below subdivides 
the  2011  MDI  and  TDI  consumption  data  for  volumes  on  the  EU  market  (EU27+Norway)  into  the 
main application categories. 

Insulating products manufactured with diisocyanates contribute highly to the EU’s food and medicine 
quality, and also significantly contribute to business and residential energy savings. CASE products 
are currently widely used, and the product properties contribute significantly to the sectors they are 
used in. 

Table 5: Yearly MDI and TDI consumption data for EU (plus Norway) subdivided into main 
application areas. 

EU27+Norway 
(2011) 

Adhesives  

Polymeric 
MDI 
(pMDI) 
(t/year) 

17 900 

Monomeric 
MDI 
(t/year) 

TDI 
(t/year) 

Total  MDI  and 
TDI 
(t/year) 

28 500 

18 300 

64 700 (4%) 

Speciality 
Diiso 
cyanates 
(t/year) 

11 600 

Coatings  

35 500 

10 900 

30 100 

76 500 (5%) 

66 800 

Elastomers  

0 

101 500 

2 500 

104 000 (7%) 

5 300 

Sealants  

5 300 

6 700 

4 400 

16 400 (1%) 

600 

97 

 
EU27+Norway 
(2011) 

Binders  

Polymeric 
MDI 
(pMDI) 
(t/year) 

145 900 

Monomeric 
MDI 
(t/year) 

TDI 
(t/year) 

Total  MDI  and 
TDI 
(t/year) 

0 

500 

146 400 (10%) 

Flexible Foam  

83 400 

32 700 

305 200 

421 300 (27%) 

Rigid Foam  

708 000 

0 

0 

708 000 (46%) 

Speciality 
Diiso 
cyanates 
(t/year) 
0 

0 

0 

Total  

996 000 

180 300 

361 000 

1 537 300 

84 300 

Source: IAL Consultants (2013) as reported by the Danish Environmental Protection Agency (2014).   
Notes: IAL Consultants roughly estimates that the uncertainty on these figures is about 5% (+/-) 

5.2.2 Existing limit values 

There  are  18  MSs  with  an  OEL,  but  they  are  mostly  for  specific  diisocyanate  compounds  and  are 
based on the molecular weight of each specific diisocyanate  compound and not on the NCO group. 
For this reason, it is not possible to present a table that gives a meaningful comparison of the levels at 
which the limits are set. Only Croatia, Ireland and Lithuania have general diisocyantes OELs. 

The  table  below  present  the  range  of  the  national  OELs  after  converting  the  level  from  molecular 
weight of the specific compound to the -NCO grouping approach. 

Table 6: Maximum, minimum and average of NCO OELs (µg/m³, 8-h TWA) in EU Member 
States for diisocyanates 

Maximum, minimum and averages 
Maximum 
Minimum 
Median 
Mode 
Mean 
Source: Study team (calculated January 2021) 

All compounds 
500 
3 
17.4 
16.8 
26.7 

98 

 
 
 
 
 
 
 
 
 
ANNEX 6: SMES 

6.1 

SMEs 

An enterprise is considered to be a medium-sized, small or micro enterprise depending on thresholds 
that have been outlined by the Commission. 

Figure 1 

Categorisation of SMEs 

SMEs  can  be  proportionately  higher  impacted  by  regulatory  changes  that  introduce  substantial 
adjustment or administrative costs. Their limited size often makes  it more difficult to access capital, 
and most often at a higher cost of capital than large enterprises.100 SMEs can therefore be exposed to 
proportionally higher costs, as compared to the large enterprises. 

The  numbers  of  small,  medium,  and  large  enterprises  likely  to  have  workers  exposed  to  lead  and 
diisocyanates in the EU is estimated in the tables below. The vast majority of companies with exposed 
workers and which are likely be affected by the limit value options are SMEs. 

6.2 Lead 

The  table  below  presents  the  estimated  share  of  small  and  medium  enterprises  as  well  as  the  total 
share  of  SMEs  out  of  all  EU  enterprises  with  exposed  workers.  Most  of  the  covered  sectors  are 
dominantly composed of SMEs. Many of the sectors entail however less than 100 enterprises across 
Europe. Sectors with a high share of SMEs as well as a high number of enterprises (i.e., above 1 000) 
are  sectors  working  with  lead  metal  (sector  10),  shooting  ranges  (sector  11),  and  the  demolition, 

100 Tool # 22 of the Better Regulation toolbox on SMEs. 

99 

 
 
 
 
 
 
 
 
                                                      
repairing,  and  scrapping  industry  (sector  13);  of  which  the  latter  is  likely  to  pass  on  costs  to 
consumers. These sectors moreover consist of nearly exclusively small enterprises. Looking across all 
sectors, small enterprises comprise the dominating share in eight (out of 15) sectors.  

When  measured  by  the  number  of  enterprises,  thus,  the  majority  of  enterprises  that  would  need  to 
comply with a stricter BLV would primarily consist of SMEs. 

Table 1: Distribution of EU enterprises with exposed workers by small and medium size, as well 
as total share of SMEs out of EU enterprises with exposed workers by sector 

Sector 

Share of no. of enterprises by size 

Small      
<50        
employees 

Medium    50-249   
employees 

Total 
SMEs 

Total no. 
of 
enterpris
es 

6 

43 

32 
26 
180  
(90-270) 

11 

46 

26 

84 

3,125  
(1 250 – 
5 000) 
4,000  
(3 000 – 
5 000) 

0% 

15% 

0% 
47% 

59% 

10% 

76% 

96% 

80% 

90% 

0% 

63% 

22% 
32% 

31% 

50% 

13% 

3% 

0% 

78% 

22% 
79% 

90% 

60% 

89% 

99% 

10% 

90% 

10% 

100% 

100% 

0% 

100% 

75% 

91% 

75% 

0% 

25% 

100% 

100 

8% 

99% 

14 179 

25% 

100% 

700 

80% 

80% 

7 

lead 

1. Primary lead production 
2.Secondary 
(including lead battery recycling) 
3. Lead battery production 
4. Production of articles of lead metal 
5. Foundries 

production  

6.  Production  of lead compounds  and 
lead frits 
7. Production of glass 
8.  Ceramic  ware  production  and 
enamelling 
9.Manufacture and use of plastics and 
paints 
10. Work with lead metal 

11. Shooting ranges 

12.  Recycling  of  PVC  and  other 
plastics 
13.  Demolition,  repairing  and  scrap 
industry 
14.  Other  waste  handling 
remediation 
15. Other (Copper production) 

and 

Source: Eurostat (2018).  

100 

 
 
 
 
 
6.3 Diisocyanates 

The table below shows the percentage of companies in key sectors that are small, medium or large. It 
is based upon the proportions for small, medium and large from Eurostat data for  enterprises at the 
NACE code. 

Table 2: Distribution of EU enterprises with exposed workers by size of enterprise by sector 
(percentages) 

NACE - Sector 

C13 Textiles 

C14 Apparel 

C15 Leather 

C16 Wood 

C20 Chemicals 

C22.21 Rigid foam 

C22.29 Flexible foam 

C22 Other 

C26 Computers 

C27Electrical equipment 

C28 Machinery 

C29 Motor vehicles 

C30 Transport 

C31 Furniture 

C33 Machinery repair 

F41.2 Construction 

F42 Civil engineering 

F43Specialised 
construction 

F43.29Other installation 

G45.2 Vehicle repair 

S95 Repairs 

Source: Eurostat (2018).  

Small 

96.56% 

97.50% 

96.10% 

97.50% 

88.00% 

53.00% 

87.00% 

53.00% 

92.00% 

86.00% 

93.00% 

83.00% 

92.00% 

97.87% 

98.25% 

99.21% 

95.00% 

99.56% 

99.39% 

99.80% 

99.93% 

Number of enterprises 

Medium 

2.96% 

2.00% 

3.42% 

1.50% 

9.00% 

35.00% 

9.00% 

35.00% 

6.00% 

10.00% 

6.00% 

10.00% 

6.00% 

1.80% 

1.50% 

0.73% 

4.00% 

0.40% 

0.55% 

0.17% 

0.06% 

Large 

0.48% 

0.50% 

0.48% 

1.00% 

3.00% 

12.00% 

4.00% 

12.00% 

2.00% 

4.00% 

1.00% 

7.00% 

2.00% 

0.33% 

0.25% 

0.06% 

1.00% 

0.04% 

0.06% 

0.03% 

0.01% 

Total 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

100% 

101 

 
 
 
ANNEX 7: PROCESS FOR SETTING BINDING OELS, BLVS AND ASSOCIATED PROVISIONS  

What are limit values? 

Occupational Exposure Limits 

OELs are the limit of the Time-Weighted Average (TWA) of the concentration for a chemical in 
the air within the breathing zone of a worker in relation to a specified reference period (normally 8 
hours). 

Short Term Exposure Limits 

STEL values, usually involving a 15-minute reference period are used when adverse health effects 
are  not  adequately  controlled  by  compliance  with  an  8-hour  TWA  OEL,  e.g.  for  substances  for 
which  a  critical  effect  is  observed  following  a  brief  exposure  (e.g.  acute  toxic  substances, 
substances causing nuisance, irritation, central nervous system depression, sensitisation). 

Biological Limit Values 

BLVs are the limit of the concentration in the appropriate biological medium of the relevant agent, 
its metabolite, or an indicator of effect (in the case of lead, in the blood of the exposed worker).  

Notations 

OELs,  STELs  and/or  BLVs  can  further  be  annotated  with  appropriate  indications  of  additional 
body burden resulting from non-inhalation routes such as, for example, a 'skin' notation where the 
dermal route of exposure is scientifically considered to be relevant. 

The  European  Agency  for  Safety  and  Health  at  Work  (EU-OSHA),  in  a  European  risk  observatory 
report101,  states  that  OELs  are  one  of  the  major  control  instruments  for  workers’  exposure  to 
chemicals; they belong to the most important tools for exposure assessment and management. 

The  advantages  of  limit  values  are  that  they  provide  clarity  and  objectivity.  They  are  very  relevant 
quantitative  benchmarks  for  employers  enabling  them  to  know  exactly  the  levels  above  which 
exposure cannot occur. Limit values also allow employers to determine the level below which their 
risk management measures should aim to comply with the obligation to eliminate or to minimise the 
exposure to as low a level as possible102.  

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

https://osha.europa.eu/en/publications/exploratory-survey-occupational-exposure-limits-oels-carcinogens-

101 
mutagens-and  
102  ECHA 
https://echa.europa.eu/documents/10162/22786913/sds_es_guide_en.pdf  

(2018),  Guide  on  Safety  data 

sheets 

and 

exposure 

scenarios.  Available 

at: 

102 

 
 
 
 
 
 
                                                      
 
 
below  the  limit  values.  They  inform  employees  about  the  risks  which  exposure  can  cause  and  put 
them in a position to check that the necessary protective measures are taken to protect their health. 

The figure below summarises the process of setting EU limit values. 

Figure 1: simple representation of EU limit value setting procedure (Source: ECHA website) 

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 2020  - 2021 and addressed the amendment of CAD 
and CMRD. Annex 2 provides further information on the outcomes of the consultation. 

Step 2:  Priority  setting 

It  is  not  realistic  to  set  an  OEL  for  every  hazardous  chemical  that  may  be  used  at  the  workplace.  
Instead it is appropriate to identify and target priority substances. 

The  selection  of  the  substances  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); 

103 

 
 
 
 
 
 

 

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 ill-health occupational 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, reprotoxic etc) which could be prevented by establishing an EU level OEL and/or 
BLV.  

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

Step 3:  Scientific evaluation and public consultation 

Article  3  of  the  CAD  and  article  16  of  the  CMRD  state  that  scientific/feasibilty  data  should  be 
included in the basis on which binding OELs and BLVs are set, but  the directives do not determine 
which  scientific  body  should  be  the  source  of  such  data.  However,  based  on  a  Service  Level 
Agreement  (SLA)  signed  by  DG  EMPL  and  ECHA,  this  Committee  assists  the  Commission 
delivering  scientific  evaluations,  upon  request,  on  the  toxicological  profiles  of  each  of  the  selected 
priority  chemical  substances  in  relation  to  their  adverse  health  effects  on  workers.  These  scientific 
evaluations  shall,  where  appropriate,  include  proposals  for  Occupational  Exposure  Limit  values 
(OELs), biological limit values (BLVs)/biological guidance values and/or notations.  This task shall 
be carried out on the basis of the latest available scientific and technical data and take into account the 
specific context of occupational exposures at the workplace.   

Scientific  information  from  other  sources  can  also  be  taken  into  account  as  long  as  the  data  is 
adequately robust and is in the public domain (e.g. conclusions of national limit vlaue-setting science 
committees). 

RAC  carries  out  scientific  evaluation  at  EU  level  based  on  the  methodology  agreed  withing  the 
ECHA/RAC-SCOEL Joint Task Force and as a result publish an Opinion on scientific evaluation of 
occupational exposure limits for the selected priority chemical substances.  

RAC  procedure  for  the  adoption  of  an  Opinion  includes  an  external  consultation  of  relevant 
stakeholders.  This  ensures  scrutiny  of  the  scientifc  evidence  and  methodological  approach  used  by 
RAC and ensures transparency of the process.  

RAC  has  concluded  Opinions  on  lead  and  diisocyanates  analysed  in  section  6  –  further  details  are 
provided in Annex 1.   

More  information  on  the  ECHA  methodology  used  by  RAC  can  be  found  on  the  ECHA  website: 
https://echa.europa.eu/en/about-us/who-we-are/committee-for-risk-assessment 

Step 4:  Tripartite consultation of Member States and social partners 

While  the  aim  of  ensuring  the  protection  of  the  health  of  workers  is  maintained,  binding  OELs  set 
under CMRD 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. 

104 

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

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

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

It  is  during  these,  often  complex,  discussions  that  the  level  of  ambition  which  is  appropriate  for  a 
specific EU limit value (OEL, STEL or BLV) for a substance is established, taking into account the 
views of representatives from the government, workers’, and employers’ interest groups. 

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

The adopted ACSH Opinions include, where necessary, specific comments from the interest groups 
(government, employers and workers) which broadly reflect the principal points maintained by each 
interest group throughout discussions of the Working Party on Chemicals (WPC).  

The ACSH has adopted opinions for the priority substances foreseen for this amendment of CAD and 
CMRD. 

In  practice,  a  limit  value  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 the 
limit values exist within the broader context of the  CAD and  CMRD general  obligations to prevent 
risks to workers’ health  (exposure elimination/reduction, process enclosure etc.), which establishes an 
appropriate and exceptionally high legal standard for workplace- and process-specific risk control. 

Step 5:  Impact assessment 

Between  2020  and  2021,  an  external  contractor  evaluated,  on  behalf  of  the  Commission,  health, 
socioeconomic and environmental impacts of the proposed amendments to CAD and CMRD in order 
to perform an impact assessment according to the regulatory procedures in place.  

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

The options for action proposed by the ACSH are established through a thorough scientific, technical 
and  socioeconomic  discussion  and  in  general  the  tripartite  agreements  reached  in  the  Advisory 
Committee would be put forward in the eventual Commission's proposal. However, in line with the 
Better  Regulation  guidelines,  an  IA  is  conducted  before  presenting  the  proposal.  In  the  IA  the 
Commission verifies the ACSH opinions on the basis of a dedicated study. 

105 

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

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

An option is retained if the ACSH opinion has been clear and consensual, there are no concerns about 
the  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. 

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

After  completion  of  these  steps,  the  Commission  prepares  the  legislative  proposal  which  will  be 
adopted following the ordinary legislative procedure. The adopted Directive will be published in the 
EU  Official  Journal  and  Member  States  will  then  transpose  the  limit  values  and  any  associated 
notation into their national legislation by the date set in the Directive. 

The limit values 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 limit values.  

Within the CAD and CMRD there are obligations for employers to apply the appropriate measures at 
the  workplace  to  ensure  that  the  exposure  of  workers  to  these  substances  do  not  exceed  the  limit 
values.  The  monitoring  of  the  correct  implementation  of  the  national  legislation  that  transposes  the 
EU  directives  and  enforcement  will  be  undertaken  by  national  authorities,  in  particular  the  national 
labour inspectorates. 

106 

 
 
 
ANNEX 8: CONSISTENCY AND COMPLEMENTARITY WITH THE REACH REGULATION  

Restrictions under REACH103 

Lead carbonates (restriction no. 16) and lead sulphates (restriction no.17) 

Shall  not  be  placed  on  the  market,  or  used,  as  substances  or  in  mixtures,  where  the  substance  or 
mixture is intended for use as paint. However, Member States may, in accordance with the provisions 
of  International  Labour  Organization  (ILO)  Convention  13,  permit  the  use  on  their  territory  of  the 
substance or mixture for the restoration and maintenance of works of art and historic buildings and 
their interiors, as well as the placing on the market for such use. 

Lead and its compounds 

Lead and its compounds (restriction no. 63) are restricted under the REACH Regulation and shall not 
be placed on the market or used in any individual part of jewellery articles if the concentration of lead 
(expressed as metal) in such a part is equal to or greater than 0.05 % by weight.  

Name of agent in Annex XVII 

Entry No. 

Conditions of the restriction 

Lead and its compound 

63 

https://echa.europa.eu/documents/10162/
654a4f38-ebdb-b3b0-bda0-
892bd44001de 

In addition, lead [CAS No 7439-92-1] has been identified as an SVHC and placed on the candidate 
list  for  inclusion  into  Annex  XIV  since  June  2018,  on  the  grounds  that  it  is  a  substance  toxic  to 
reproduction. 

There is also a general restriction (no. 30) concerning reprotoxic substances that shall not be placed on 
the market, or used as substances, as constituents of other substances, or in mixtures, for supply to the 
general public. 

Diisocyanates 

Diisocyanates  are  restricted  under  the  REACH  Regulation  and  shall  not  be  used  or  placed  on  the 
market as substances on their own, as a constituent in other substances or in mixtures for industrial 
and  professional  uses  unless  the  employer  or  self-employed  ensures  that  industrial  or  professional 
user(s) have successfully completed training on  the safe use of diisocyanates prior to the use of the 

103https://echa.europa.eu/substances-restricted-under-
reach?p_p_id=disslists_WAR_disslistsportlet&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&_disslist
s_WAR_disslistsportlet_orderByCol=prc_entry_no&_disslists_WAR_disslistsportlet_substance_identifier_field
_key=&_disslists_WAR_disslistsportlet_delta=50&_disslists_WAR_disslistsportlet_orderByType=asc&_disslis
ts_WAR_disslistsportlet_doSearch=&_disslists_WAR_disslistsportlet_prc_entry_no=&_disslists_WAR_disslist
sportlet_deltaParamValue=50&_disslists_WAR_disslistsportlet_resetCur=false&_disslists_WAR_disslistsportle
t_cur=1  

107 

 
 
                                                      
substance(s)  or  mixture(s).  A  Commission  Regulation  was  also  recently  adopted  amending  Annex 
XVII to REACH and introducing detailed training requirements for workers104. 

Name of agent in Annex XVII 

Entry No. 

Conditions of the restriction 

Diisocyanates 

74 

https://echa.europa.eu/documents/10162/
503ac424-3bcb-137b-9247-
09e41eb6dd5a 

The  combination  of  REACH  Restriction  and  OSH  provisions, especially  a  binding  OEL  and  health 
surveillance  established  in  the  frame  of  CAD  is  the  most  efficient  approach  for  preventing  peak 
exposure which is the key event leading to asthma from exposure to diisocyanates. 

104See footnote 65.  

108