COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT 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) 36 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  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) 35 final}  
 
 
Why? What is the problem being addressed?  

A.  Need for action 

This  initiative  addresses  occupational  ill-health  caused  by  two  groups  of  chemicals,  lead  and  its 
inorganic  compounds  (hereinafter  ‘lead’),  and  diisocyanates.  The  regulation  of  lead  in  occupational 
settings  falls  under  the  scope  of  the  Carcinogens,  Mutagens  and  Reprotoxic  Substances  Directive 
(CMRD)  (Directive  2004/37/EC),  following  an  agreement  in  March  2022  between  the  European 
Parliament and Council to expand the scope of the Carcinogens and Mutagens Directive 2004/37/EC 
(CMD) to include reprotoxic substances. The binding biological limit value (BLV1) and occupational 
exposure  limit  (OEL2)  for  lead  under  the  CMRD  were  first  introduced  in  1982  under  a  specific 
directive  on  lead,  and  have  not  been  updated  since.  The  regulation  of  diisocyanates  falls  under  the 
Chemical Agents Directive (CAD) (Directive 98/24/EC). There is currently no EU OEL or short-term 
exposure limit value (STEL3) for diisocyanates. 

Lead  is  a  key  occupational  reprotoxicant  that  can  affect  sexual  function  and  fertility  and  the 
development  of  the  foetus  or  offspring  (developmental  toxicity)4.  It  can  also  have  harmful  health 
effects such as 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-health5.  The  risk  of  exposure  to  lead  occurs  in  mining  and  primary  processing  and 
subsequent  use  in  products  such  as  batteries,  and  due  to  its  historical  uses  in  renovations,  waste 
collection, recycling and remediation. Since the primary routes of exposure are inhalation and hand-to-
mouth transmission and ingestion, lead concentrations in blood are the best exposure metric, as they 
cover both exposure routes. Between 50 000 and 150 000 workers in the EU27 are exposed to lead, 
and around 300 cases of ill-health occur annually due to past occupational exposure. One of the aims 
in  the  green  and  digital  transition  is  to  reduce  emissions  from  cars  by  55%  by  2030  and  eliminate 
emissions from new cars by 2035, while setting a target of 13 million low- and zero-emission vehicles 
by  20256.  In  this  context,  the  desire  to  increase  the  use  of  electric  transportation  and  of  batteries  in 
electricity  grids  may  result  in  an  increased  use  of  lead  (estimated  annual  growth  of  25%7),  and 
therefore, in additional occupational exposures.  

effects 

Diisocyanates  are  skin  and  respiratory  sensitisers  (asthmagens)  that  can  have  harmful  respiratory 
and  bronchial 
asthma, 
health 
hyperresponsiveness,  as  well  as  dermal  occupational  disease8.  This  can  happen  both  after  acute  and 
long-term exposure. Occupational factors account for 9-15% of asthma cases in adults of working age. 

as  occupational 

sensitisation 

isocyanate 

such 

1  BLV  means  the  limit  of  the  concentration  in  the  appropriate  biological  medium  of  the  relevant  agent,  its 
metabolite, or an indicator of effect. 
2 ‘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. 
3  Diisocyanate  substances  have  a  common  mechanism  of  inducing  hypersensitivity  mechanisms.  Therefore,  a 
group approach is supported by the European Chemicals Agency’s (ECHA) Risk Assessment Committee (RAC) 
to cover a broad range of individual diisocyanate substances. 
4 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. 
5 https://ec.europa.eu/social/main.jsp?catId=738&langId=en&pubId=8220&furtherPubs=yes  
6 https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal/delivering-european-green-deal_en  
https://ec.europa.eu/commission/presscorner/detail/en/fs_19_6726  
7 WEF_A_Vision_for_a_Sustainable_Battery_Value_Chain_in_2030_Report.pdf (weforum.org) 
8  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 number of annual cases of diisocyanate-related occupational asthma in the EU range from 2 350 
to 7 269 cases9 10 11.  

Occupational  exposure  to  diisocyanates  occurs  primarily  in  the  manufacturing  of  polyurethane  as 
solids  and  foams,  plastics,  coatings,  varnishes,  two-pack  paints,  and  adhesives.  These  products  are 
widely  used  in  construction,  vehicle  repairs,  general  repairs  and  the  manufacturing  of  textiles, 
furniture,  motor  vehicles  and  other  means  of  transport,  domestic  appliances,  machinery,  and 
computers. An estimated 42 million workers are exposed to diisocyanates. Actions taken as part of the 
European Green Deal’s Renovation Wave to increase the thermal insulation of the built environment 
could increase the risk of exposure to diisocyanates.  

In case of no action at EU level, based on current exposure data around 298 cases of ill-health and 36 
cases of developmental toxicity are predicted annually. Over 40 years, this would mean 12 000 cases 
of lead-related ill-health and 1 400 cases of developmental toxicity for a workforce of 98 850. As for 
diisocyanates,  5 000  cases  of  asthma  and  1 300  cases  of  irritation  (e.g.  of  the  skin,  mucous 
membranes,  eyes,  and  the  respiratory  tract)  are  estimated  to  occur  annually.  The  health  costs  in  the 
EU27 over 40 years would amount to EUR 612.7 million (present value) for lead-related exposure, to 
EUR 7.2 billion for asthma and to EUR 10.4 million for irritation, as a consequence of exposure to 
diisocyanates.   

What is the initiative expected to achieve?  

The  overarching  objective  of  this  initiative  is  to  further  strengthen  workers’  right  to  a  high  level  of 
protection  of  their  health  and  safety  at  work  by  reducing  occupational  exposure  to  lead  and 
diisocyanates. This initiative will pursue the following specific objectives:  

1. 

2. 
3. 

to enhance the effectiveness of the occupational exposure and biological limit values for lead 
under the CMRD on the basis of scientific and technical knowledge;   
to enhance the effectiveness of the CAD by introducing limit values for diisocyanates;  
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.  

What is the added value of action at EU level? 

The current EU limit values of an OEL of 0.150 mg/m³ and a BLV of 70 µg/100 ml blood have not 
been updated for more than 40 years, meaning that workers in the EU are currently subject to different 
levels  of  protection  against  exposure  to  lead.  Member  States  have  reduced  exposure  to  varying 
degrees.  At  present,  15  Member  States  have  an  OEL  equal  or  lower  than  the  EU  value,  with  the 
figures ranging from 0.05 mg/m3 up to 0.15 mg/m3 (the current OEL under CMRD).  

For  diisocyanates,  three  Member  States  have  a  general  OEL,  and  several  have  different  OELs  for 
some, but not all diisocyanates. 17 have a STEL.  

Revising the CMRD and the CAD will bring the same minimum standards across all Member States, 
while  they  will  remain  free  to  set  stricter  levels.  This  will  lead  to  greater  harmonisation,  thus 

9 Work-related asthma in Great Britain 2021 (hse.gov.uk) 
10 Occupational Exposure to Diisocyanates in the European Union | Annals of Work Exposures and Health | 
Oxford Academic (oup.com) 
11 As per footnote 8 - RPA study 2021 (external study supporting the impact assessment). 

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contributing to a better protection of workers, especially from diisocyanates. This will also contribute 
to a more level playing field for businesses across the EU and will likely result in a fairer distribution 
and  reduction  of  healthcare  costs  for  the  different  Member  States.  It  also  eliminates  the  need  for 
Member  States  to  conduct  their  own  scientific  analyses,  with  likely  substantial  savings  on 
administrative costs. Amending the CAD and CMRD can only be done at EU level.  

B.  Policy options 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 
choice or not? Why?  

Several scenarios have been assessed considering the scientific assessment carried out by the European 
Chemicals  Agency’s  (ECHA)  Risk  Assessment  Committee  (RAC),  the  opinions  from  the  Advisory 
Committee for Safety and Health at Work (ACSH), as well as the OELs, BLVs and STELs in place in 
the different Member States. The scientific evaluation provides a solid evidence base, while the ACSH 
opinions, which  consider also socio-economic and feasibility aspects, provide important information 
regarding the successful implementation of the revised and new limit values.  

For  lead,  four  options  for  a  BLV  (µg/100  ml)  were  considered  during  the  impact  assessment:  70 
(baseline), 20, 15, and 4.5. It is not possible to establish a clear numerical correlation between levels of 
lead in air to which workers are exposed and the subsequent levels of lead in their blood. Therefore, it 
is  not  possible  to  identify  OEL  options  and  independently  assess  their  impacts  with  any  degree  of 
certainty.  However,  a  numerical  value  for  a  revised  OEL  is  presented  based  on  the  views  of  key 
stakeholders in the ACSH opinion.  

For  diisocyanates,  the  following  options  for  an  OEL  (µg  NCO/m3)  were  considered:  no  level 
(baseline), 10, 6 and 3, together with a STEL. 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.  

Based on a thorough impact assessment,  a BLV for lead  of 15 µg/100ml blood,  accompanied by an 
OEL of 0.03mg/m3 as an 8-hour time weighted average (TWA) were chosen as the preferred options. 
For  diisocyanates,  an  OEL  of  6µg/m3  with  a  STEL  of  12  µg/m3  and  a  dermal  and  respiratory 
sensitisation  notation  and  skin  notation  are  the  preferred  options.  Moreover,  for  diisocyanates,  a 
transitional value of 10µg/m3 with a STEL of 20µg/m3 should apply until 31 December 2028. These 
represent the best scenarios in terms of effectiveness, efficiency and coherence.  

Who supports which option?  

The  formal  two-stage  social  partner  consultation  confirmed  the  need  to  revise  the  current  BLV  and 
OEL for lead and to propose an OEL and STEL for diisocyanates. In their opinion of November 2021, 
all  three  Interest  Groups  of  the  ACSH  supported  the  need  to  revise  downwards  the  limit  values  for 
lead and to introduce limit values for diisocyanates. While the preferred option for lead has the support 
of  the  Employers’  Interest  Group  and  Governments’  Interest  Group,  the  Workers’  Interest  Group 
supported lower values. The preferred option for diisocyanates is fully supported by all three interest 
groups in the ACSH.  

What are the benefits of the preferred options?  

C.  Impacts of the preferred option 

3 

 
 
For  lead,  thanks  to  this  initiative,  10 500  cases  of  ill-health  could  be  prevented,  with  a  monetised 
health benefit ranging between EUR 160 and 250 million over the next 40 years. For diisocyanates, a 
lack of data means that it is not possible to quantify benefits for workers, but there is strong agreement 
between  stakeholders,  including  social  partners,  that  a  STEL  would  reduce  the  number  of  ill-health 
cases.   

The proposed action will, among others, reduce the suffering of workers and their families and lead 
them  to  enjoy  longer,  better  quality  and  more  productive  lives.  It  can  also  make  the  sectors  more 
attractive, making it easier to recruit workers and increase productivity.  

What are the costs of the preferred options?  

Actions to adjust working practices (risk management measures, health surveillance, monitoring and 
training)  to comply  with  the  new  values  will result  in  increased costs  for  companies.  The estimated 
cost  of  the  preferred  options  is  overall  bearable  for businesses.  For lead, the costs  would  amount to 
EUR  30 000  per  company  over  40  years  (less  than  1%  of  their  turnover).  For  diisocyanates,  a 
company would have to spend EUR 6 000 over 40 years, which would not represent a significant share 
of  their  turnover  either.  Since  these  are  sectors  with  a  high  degree  of  competition,  impacts  on 
consumers are expected to be limited. 

How will businesses, SMEs and micro-enterprises be affected?  

Businesses  will  benefit  from  updated  limit  values for  lead and from  the introduction  of an  OEL  for 
diisocyanates,  as  this  will  simplify  provisions  for  compliance  across  Member  States,  and  it  will 
eliminate the need to conceive and apply tailored measures in each Member State. This will especially 
benefit companies operating across Member States. Such companies will also benefit from improved 
labour productivity,  lower costs  of sick  leave  and  other costs  related  to the  replacement  of  workers. 
These benefits would be between EUR 5 million and EUR 6 million in the EU27 over 40 years. Since 
99% of companies working with lead and diisocyanates in the EU are SMEs, the impacts identified in 
this report apply to them too.  

Will there be significant impacts on national budgets and administration?  

Additional  administrative  and  enforcement  costs  that  might  be  incurred  by  enforcing  authorities  are 
not expected to be significant. The reduction of ill-health cases will contribute to mitigating financial 
losses  as  burdens  to  social  security  and  health  care  systems  are  reduced.  The  estimated  savings  for 
public authorities are around EUR 100 million for lead over 40 years, which outweighs the costs (EUR 
500 000).  For  diisocyanates,  public  administrations  in  the  EU  will  have  to  incur  one-off  costs  of 
around EUR 970 000, also expected to be offset by the benefits (EUR 1 750 000).   

Will there be other significant impacts?  

The  preferred  options  will  have  a  positive  impact  on  fundamental  rights,  especially  with  regard  to 
Article 2 (right to life),  and Article  31 (right to  fair and just working conditions which  respect their 
health, safety and dignity) of the Charter of Fundamental Rights of the European Union. 

Moreover,  this  proposal  will  contribute  positively  to  the  Sustainable  Development  Goals  on  good 
health and well-being (SDG 3) and decent work and economic growth (SDG 8). A positive impact is 
also  expected  on  SDG  9  on  industry,  innovation  and  infrastructure  and  SDG  12on  responsible 
production and consumption.  

4 

 
 
When will the policy be reviewed? 

D.  Follow-up 

The effectiveness of the proposed revisions of the CMRD and the CAD will be measured as part of of 
the  evaluation  of  the  EU  Occupational  Safety  and  Health  Directives  as  set  out  in  Article  17a  of 
Directive 89/391/EEC.  

5