COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the document Proposal for a Directive of the European Parliament and of the Council amending Directive 2004/37/EC as regards the addition of substances and setting limit values in its annexes I, III and IIIa
Date: 2025-07-18
Institutions: Directorate-General for Employment, Social Affairs and Inclusion, European Commission
Subjects: carcinogenic substance, health risk, occupational disease, occupational health, safety standard, toxic substance

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 18.7.2025  SWD(2025) 191 final  COMMISSION STAFF WORKING DOCUMENT Subsidiarity Grid Accompanying the document Proposal for a Directive of the European Parliament and of the Council   amending Directive 2004/37/EC as regards the addition of substances and setting limit values in its annexes I, III and IIIa       {COM(2025) 418 final} - {SEC(2025) 217 final} - {SWD(2025) 192 final} - {SWD(2025) 193 final}  
 
 
Subsidiarity Grid 

-  As proposed by the Committee of the Regions with guidance in blue  

-  Obviously, the answers to the questions below, the explanatory memorandum and – if 

applicable – the impact assessment should be consistent. This may require some iterations.  

-  Please try to stay under 10 pages.  

1.  Can the Union act? What is the legal basis and competence of the Unions’ intended action? 

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy initiative? 

Article  153  of  the  Treaty  on  the  Functioning  of  the  European  Union  (TFEU),  which  empowers  the 
European  Union  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. 

Article 154  of the  TFEU, which requests the  Commission to initiate a two-stage  consultation of the 
social partners at the EU level prior to submitting proposals in the social policy field. 

1.2 Is the Union competence represented by this Treaty article exclusive, shared or supporting in 
nature? 

In  the  case  of  social  policy,  the  Union’s  competence  is  shared.  Article  153(1)(a)  of  the  TFEU  states 
that  the  Union  shall  support  and  complement  the  activities  of  the  Member  States  in  the  field  of 
“improvement in particular of the working environment to protect workers’ health and safety”. 

Subsidiarity does not apply for policy areas where the Union has exclusive competence as defined in 
Article 3 TFEU1. It is the specific legal basis which determines whether the proposal falls under the 
subsidiarity control mechanism. Article 4 TFEU2 sets out the areas where competence is shared 
between the Union and the Member States. Article 6 TFEU3 sets out the areas for which the Unions 
has competence only to support the actions of the Member States. 

2.  Subsidiarity Principle: Why should the EU act? 

2.1 Does the proposal fulfil the procedural requirements of Protocol No. 24: 

-  Has there been a wide consultation before proposing the act? 
- 

Is there a detailed statement with qualitative and, where possible, quantitative indicators 
allowing an appraisal of whether the action can best be achieved at Union level? 

-  As requested by the TFEU Article 154, a formal two-stage consultation of the social partners 
at  EU  level  is  required  prior  to  submitting  proposals  in  the  social  policy  field.  Such  a  two-
stage consultation was performed in 2023. The Commission has also consulted the tripartite 
Advisory  Committee  on  Safety  and  Health  at  Work  (ACSH)  and  its  Working  Party  on 

1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E003&from=EN  
2 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E004&from=EN  
3 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12008E006:EN:HTML  
4 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  

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Chemicals  (WPC),  both  composed  of  representatives  from  Member  States,  representing 
national  governments,  workers’  and  employers’  organisations.  The  ACSH  has  adopted 
opinions on the 5 prioritised hazardous substances on 22 September 2023.  

- 

The explanatory memorandum and the impact assessment contain a section on the principle 
of subsidiarity. More information is available in question 2.2 below. 

2.2 Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the conformity with the 
principle of subsidiarity? 

Both  the  explanatory  memorandum  and  the  impact  assessment  accompanying  the  Commission’s 
proposal contain a justification regarding the conformity with the principle of subsidiarity.  

In the absence of EU values, Member States are free to adopt national limit values. Where they exist, 
the  national  limit  values  for  the  3  substances  subject  to  the  setting  of  a  limit  value  as  part  of  this 
initiative vary considerably between Member States. For instance, the national limit values for cobalt 
range from 10 to 500 µg/m3. Some Member States have therefore set limit values fifty times lower 
than others for the same substance. Five Member States have no limit values for cobalt5.  

Under  such  circumstances,  minimum  requirements  for  workers’  health  protection  against  the  risks 
arising from exposure to these substances cannot be ensured for all EU workers in all Member States 
by actions taken by Member States alone. 

In  addition,  setting  EU  limit  values  helps  to  provide  a  level  playing  field  for  industry  as  some 
employers' organisations stressed in their response to the social partner consultation. 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. 

Setting EU limit values will not completely eliminate the  differences between Member States since 
they can adopt more protective (lower) limits. However, it will reduce the scope for divergences and 
enhance certainty that there is a core definition and/or enforceable exposure limit for all concerned 
carcinogens and reprotoxic substances in all Member States. It will also reduce regulatory complexity 
resulting  from  highly  diverging  rules  between  Member  States,  contributing  to  reduce  the 
administrative burden of compliance for businesses operating across the single market. 

Regarding welding fumes, the complexity and heterogeneity of their composition, together with the 
absence  of  harmonised  classification  in  the  CLP  Regulation6,  contribute to  a  lack  of  clarity on their 
possible dangerousness for workers, and therefore a lack of appropriate risk management measures 
at  the  workplace.  Addressing  this  absence  of  classification  for  welding  fumes  at  EU  level  would 
ensure more legal clarity, which would result in better implementation of the existing EU rules. 

Governments’,  employers’  and  workers’  representatives  have  expressed  clear  support  for 
establishing limit values for the substances subject to this initiative, and for including welding fumes 
in Annex I of the Carcinogens, Mutagens and Reprotoxic substances Directive 2004/37/EC (CMRD), as 
it clearly results from the two-stage consultation of social partners and the opinions of the tripartite 
ACSH.  

2.3 Based on the answers to the questions below, can the objectives of the proposed action be 

5 IT, LU, MT, PT, SI 
6 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC 
and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, p. 1-1355 

2 

 
 
 
 
achieved sufficiently by the Member States acting alone (necessity for EU action)? 

Risks to workers’ health and safety are broadly similar across the European Union. National actions 
alone lead to insufficient and divergent levels of protection of workers’ health, as well as to an 
uneven playing field for businesses. 

(a)  Are there significant/appreciable transnational/cross-border aspects to the problems being 

tackled? Have these been quantified? 

Risks  to  workers’  health  and  safety  are  broadly  similar  across  the  European  Union.  However,  data 
gathered  in  the  preparatory  work  indicates  differences  in  the  Member  States  regarding  the  limit 
values.  For  instance,  9  Member  States  have  currently  no  limit  value  for  polycyclic  aromatic 
hydrocarbons.  Therefore,  such  differences  in  limit  values  result  in  high  disparities  in  the  levels  of 
protection of workers’ health in the different Members States. 

(b)  Would national action or the absence of the EU level action conflict with core objectives of 

the Treaty7 or significantly damage the interests of other Member States? 

National  actions  alone  lead  to  high  disparities  between  the  existing  national  limit  values,  with  the 
consequences in point 2.3 (a) above. EU  level action would  not conflict with core objectives of the 
Treaty  or  significantly  damage  the  interests  of  other  Member  States.  On  the  contrary,  it  would 
enable among others to: 

- 
- 
- 
- 

ensure a similar and fair minimum level of protection across the European Union; 
contribute to a level playing field; 
improve clarity and enforcement of the CMRD; and 
assume  burdens  at  EU  level  related  to  revision  of  the  limit  values  or  the  list  of  process-
generated  substances  by  eliminating  the  need  for  Member  States  to  individually  conduct 
their own scientific analyses. 

(c)  To what extent do Member States have the ability or possibility to enact appropriate 

measures? 

The  CMRD  aims  to  protect  workers  from  the  health  and  safety  risks  related  to  exposure  to 
carcinogens, mutagens or substances toxic to reproduction at work. A consistent level of protection 
from  the  risks  related  to  these  substances  is  provided  for  by  a  framework  of  general  principles  to 
enable  Member  States  to  ensure  the  consistent  application  of  the  minimum  requirements.  The 
minimum  requirements  provided  for  in  the  CMRD  aim  to  protect  workers  at  Union  level.  More 
stringent binding limit values or other protective measures can be set by Member States. 

(d)  How does the problem and its causes (e.g. negative externalities, spill-over effects) vary 

across the national, regional and local levels of the EU? 

Risks to workers’ health and safety are broadly similar across the European Union.  

However,  in  the  absence  of  EU  action,  the  level  of  workers’  protection  from  exposure  to  the 
prioritised  substances  can  diverge  from  a  Member  State  to  another  depending  among  others  on 
whether  national  limit  values  have  already  been  revised  following  scientific  development  or  if 
welding  fumes  are  already  classified  as  process-generated  substances.  Furthermore,  the  existing 
national limit values are much higher than the limit values recommended by the European Chemicals 
Agency’s Risk Assessment Committee, leading to likely insufficient protection of workers. 

7 https://europa.eu/european-union/about-eu/eu-in-brief_en  

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(e)  Is the problem widespread across the EU or limited to a few Member States? 

Although Member States may already have limit values for some of the substances addressed in this 
initiative,  the  problem  is  widespread  across  the  European  Union  as  risks  to  workers’  health  and 
safety are broadly similar. As explained above, the existing national limit values are much higher than 
the  limit  values  recommended  by  the  European  Chemicals  Agency’s  Risk  Assessment  Committee, 
leading to likely insufficient protection of workers. 

(f)  Are Member States overstretched in achieving the objectives of the planned measure? 

The process of establishing limit values or modifying the list of process-generated substances is very 
complex and requires a high level of scientific expertise. This could partly explain why some Member 
States have no limit values yet for some of the substances addressed in this initiative or have not yet 
classified  welding  fumes  as  process-generated  substances.  An  important  advantage  of  addressing 
this issue at EU level is that it eliminates the need for Member States to conduct their own scientific 
analysis  with  likely  substantial  savings  on  administrative  costs.  Given  the  limited  resources  for 
occupational safety and health (OSH) at national level, this could release funds to be redirected into 
other OSH priorities. 

(g)  How do the views/preferred courses of action of national, regional and local authorities 

differ across the EU? 

The tripartite ACSH, in September 2023, reached a consensus on the need to set binding limit values 
or  introduce  in  the  list  of  process-generated  substances  the  substances  prioritised  as  part  of  this 
initiative in view of better protecting workers’ health and safety and thus reduce the probability for 
occupational diseases to happen. 

2.4 Based on the answer to the questions below, can the objectives of the proposed action be 

better achieved at Union level by reason of scale or effects of that action (EU added value)? 

Acting  at  the  EU  level  would  enable  among  others  to  ensure  a  fair  similar  minimum  level  of 
protection  across  the  European  Union,  contribute  to  a  level  playing  field  and  improve  clarity  and 
enforcement. Revising the limit values  at the EU level would also enable  to eliminate the need for 
Member  States  to  conduct  their  own  scientific  analyses  with  likely  substantial  savings  on 
administrative costs. 

(a)  Are there clear benefits from EU level action?  

Amending the CMRD presents an EU added value in several aspects:  

Ensuring a similar and fair minimum level of workers’ protection across the European Union; 

- 
-  Contributing to a level playing field; 
-  Assuming burdens at EU level related to revision of limit values.  

More information can be found in point 3.3 of the Impact Assessment. 

(b)  Are there economies of scale? Can the objectives be met more efficiently at EU level (larger 

benefits per unit cost)? Will the functioning of the internal market be improved? 

The  process  of  establishing  limit  values  is  very  complex  and  requires  a  high  level  of  scientific 
expertise. An important advantage of setting limit values at EU level is that it eliminates the need for 
Member  States  to  conduct  their  own  scientific  analyses.  These  economies  of  scale  should  lead  to 
likely  substantial  savings  on  administrative  costs.  Given  the  limited  resources  for  OSH  at  national 
level, this could release funds to be redirected into other OSH priorities. 
According  to  the  impact  assessment  accompanying  this  initiative,  the  benefits  related  to  avoided 

4 

 
 
costs  of  addressing  exposure  to  the  prioritised  substances  following  national  processes  would 
represent up to €3.75 million. 

(c)  What are the benefits in replacing different national policies and rules with a more 

homogenous policy approach? 

The  CMRD  does  not  aim  to  replace  national  policies  and  rules  but  rather  to  set  minimum 
requirements in order to protect workers at EU level. More stringent limit values or other protective 
measures can be set by Member States.  

However, the minimum requirements provided for in the Directives aim, among others, to ensure a 
similar minimum level of protection across the European Union while contributing to a level playing 
field and a better functioning of the internal market. 

(d)  Do the benefits of EU-level action outweigh the loss of competence of the Member States 
and the local and regional authorities (beyond the costs and benefits of acting at national, 
regional and local levels)? 

The fight against occupational diseases remains a high priority in the area of OSH at EU-level.  

The  Commission  announced  in  the  European  Pillar  of  Social  Rights  Action  Plan  the  intention  to 
ensure a healthy, safe and well adapted work environment, which was confirmed with the adoption 
of the EU OSH Strategic Framework for 2021-2027.  

Therefore,  acting  at  the  EU  level  will  enable  to  support  all  the  Member  States  in  addressing 
occupational diseases arising from exposure to chemicals at work. In addition to that, Member States 
can continue to set additional or more stringent binding limit values, or other protective measures. 

(e)  Will there be improved legal clarity for those having to implement the legislation? 

limit  values  for  cobalt  and 

Establishing 
inorganic  cobalt  compounds,  polycyclic  aromatic 
hydrocarbons and 1,4-dioxane will provide common reference points that are used as a practical tool 
by  employers,  workers  and  enforcers  to  assess  compliance  with  the  general  requirements,  in 
particular in those Member States with no existing limit values.  

The complexity and heterogeneity of the composition of welding fumes, together with the absence 
of harmonised classification for welding fumes in the CLP Regulation, contribute to a lack of clarity on 
the possible dangerousness of welding fumes for workers, and therefore a lack of appropriate RMMs. 
Addressing  this  absence  of  classification  for  welding  fumes  at  EU  level  would  ensure  more  legal 
clarity, which would result in better implementation of the existing rules. 

3.  Proportionality: How the EU should act 

3.1  Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the proportionality of the 
proposal and a statement allowing appraisal of the compliance of the proposal with the 
principle of proportionality? 

The  proposal  respects  the  principle  of  proportionality,  as  this  initiative  is  limited  to  revising  the 
annexes to the CMRD, where necessary, on the basis of the scientific and technical data available, as 
provided for by Article 16 of the CMRD. This initiative  aims to make  a step forward to achieve the 
objectives set to improve health and safety of workers, while imposing costs that are considered by 
businesses as acceptable and bearable. 

As shown in the impact assessment supporting this initiative, the proposal also ensures a balanced 

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approach,  i.e.  to  prevent  as  much  as  possible  industries  from  closures  or  severe  economic 
disadvantages while providing for an adequate protection of the workers at the EU level and being 
coherent  with  the  key  objectives  of  the  EU,  including  Europe’s  Beating  Cancer  Plan,  the  twin 
transition, and the EU strategic autonomy. 

Socio-economic and feasibility factors have been taken into account after intensive discussions with 
all  stakeholders  within  the  ACSH.  It  also  includes  measures  for  mitigating  burdens  and  supporting 
compliance  (including  transitional  periods)  which  have  also  been  discussed  with  the  ACSH.  These 
transitional  measures  contribute  to  the  proportionality  of  this  initiative  by  ensuring  a  more 
appropriate temporal margin for businesses to adapt, where necessary, while safeguarding the EU’s 
twin transition objective and strategic autonomy. It is expected to significantly mitigate the possible 
negative impacts on businesses and on the key objectives of the EU. 

Despite  their  high  costs,  the  measures  provided  by  this  initiative  have  the  support  of  the  key 
stakeholders  in  the  area  of  OSH,  namely  the  employers,  workers  and  national  governments 
represented  within  the  ACSH.  In  addition,  and  as  part  of  the  2nd  stage  consultation  of  social 
partners,  BusinessEurope  and  ETUC  supported  the  ACSH  opinions  while  SMEunited  calls  on  the 
Commission  not  to  go  beyond  what  was  agreed  by  the  ACSH.  These  social  partners’  views  further 
support the proportionality of the package of preferred options.  

Finally,  this  initiative  also  offers  a  certain  margin  of  flexibility  to  Member  States  as  regards  the 
substances  that  are  subject  to  the  setting  of  limit  values.  In  accordance  with  Article  153(4)  of  the 
TFEU,  setting  limit  values  at  EU  level  does  not  prevent  Member  States  from  maintaining  or 
introducing more stringent protective measures (i.e. lower limit values).  

3.2 Based on the answers to the questions below and information available from any impact 
assessment, the explanatory memorandum or other sources, is the proposed action an 
appropriate way to achieve the intended objectives? 

The European Pillar of Social Rights8, jointly proclaimed by the European Parliament, the Council and 
the  Commission  at  the  Social  Summit  for  Fair  Jobs  and  Growth  on  17  November  2017,  enshrines 
workers'  right  to  healthy,  safe  and  well-adapted  work  environment,  including  protection  from 
carcinogens. However, a lack of EU action will most likely mean that there will remain Member States 
where no limit values exist for certain carcinogens or reprotoxics or where those values are too high 
to ensure adequate worker protection.  

Therefore, it is appropriate to act at the EU level in order to ensure to the workers the right to a high 
level of protection of their health and safety at work, and to support and complement the activities 
of  the  Member  States  in  this  regard,  pursuant  to  Article  153  of  the  TFEU.  It  is  all  the  more 
appropriate  given  the  fact  that  the  CMRD  already  exists,  and  this  initiative  is  limited  to  amend  its 
Annexes I, III and IIIa on the basis of scientific and technical data available. 

(a)  Is the initiative limited to those aspects that Member States cannot achieve satisfactorily on 

their own, and where the Union can do better? 

The proposal is limited to revising the annexes of the CMRD, where  necessary, on the basis of the 
scientific and technical data available, as provided for by Article 16 of the CMRD. This initiative aims 
to make a step forward to achieve the objectives set to improve health and safety of workers, while 
imposing costs that are considered by businesses as acceptable and bearable. This initiative does not 
prevent  any  Member  State  from  maintaining  or  introducing  more  stringent  protective  measures 

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

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compatible with the Treaties. 

(b)  Is the form of Union action (choice of instrument) justified, as simple as possible, and 

coherent with the satisfactory achievement of, and ensuring compliance with the objectives 
pursued (e.g. choice between regulation, (framework) directive, recommendation, or 
alternative regulatory methods such as co-legislation, etc.)? 

Article 153(2)(b) of the TFEU allows minimum requirements in the field of workers’ health and safety 
protection to be adopted ‘by means of directives’. In addition to that, the CMRD already exists, and 
this initiative  is limited to the  amendment of Annexes  I, III and IIIa to the Directive on the basis of 
scientific and technical data available, as provided by Article 16 (1) of Directive 2004/37/EC. 

(c)  Does the Union action leave as much scope for national decision as possible while achieving 
satisfactorily the objectives set? (e.g. is it possible to limit the European action to minimum 
standards or use a less stringent policy instrument or approach?) 

Article 153(2)(b) of the TFEU only allows minimum requirements in the field of workers’ health and 
safety protection to be adopted ‘by means of directives’. These minimum requirements are proposed 
by  the  European  Commission  after  consultation  of  representatives  of  workers’  organisations, 
representatives of employers’ organisations, and representatives of governments. The provisions in 
this  initiative  do  not  prevent  any  Member  State  from  maintaining  or  introducing  more  stringent 
protective measures compatible with the Treaties.  

(d)  Does the initiative create financial or administrative cost for the Union, national 

governments, regional or local authorities, economic operators or citizens? Are these costs 
commensurate with the objective to be achieved? 

The general objective of this initiative is to ensure to workers the right to a high level of protection of 
their  health  and  safety  at  work.  This  objective  is  in  line  with  the  European  Pillar  of  Social  Rights, 
which  enshrines  workers’  rights  to  healthy,  safe  and  well-adapted  work  environment,  and  with 
Europe’s Beating Cancer Plan. Overall, this initiative is expected to prevent 1,676 lung cancer cases 
and 18,912 non-cancer disease cases over the next 40 years. 

More stringent policy options would have allowed to make even greater progress in the fight against 
occupational cancer and other work-related illnesses. However, these policy options would have had 
significant consequences on businesses, leading to a high number of discontinuations and job losses 
and a substantial loss of competitiveness for European companies operating in certain sectors. They 
would  have  negatively  impacted  the  Open  Strategic  Autonomy  of  the  EU,  as  well  as  its  transition 
towards  a  greener  and  more  digital  European  Union.  This  is  in  line  with  what  employers’ 
organisations  raised  as  part  of  the  2nd  phase  of  the  social  partners  consultation,  namely  that  this 
initiative could have more far-reaching consequences for the European industry, including in terms of 
strategic autonomy, relocation of production sites outside of the EU, etc.  In this regard, SMEunited 
called the Commission not to go beyond what was agreed by the ACSH, and by extension beyond the 
package of preferred options (except for isoprene). For its part, Business Europe supported the ACSH 
opinions. 

On the other side, some less stringent policy options (including the baseline scenario) would be less 
costly  for  businesses  than  the  package  of  preferred  options.  However,  the  positive  effect  of  these 
options  on  workers’  health  would  be  more  limited  and  would  not  consequently  contribute  to  the 
general objective in a satisfactory manner.  

Finally,  the  introduction  of  transitional  measures  for  cobalt  and  its  inorganic  compounds  and  for 

7 

 
 
polycyclic aromatic hydrocarbons is expected to significantly mitigate the possible negative impacts 
on businesses and on the key objectives of the EU. Therefore, the costs arising from this initiative are 
considered as commensurate with the key objective to be achieved.  

(e)  While respecting the Union law, have special circumstances applying in individual Member 

States been taken into account? 

The European Commission consulted the tripartite ACSH, composed of three full members per 
Member State, representing national governments, trade unions and employers’ organisations.  This 
broad representation enables to take into account special circumstances applying in individual 
Member States. 

8