COMMISSION STAFF WORKING DOCUMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures
Date: 2022-12-19
Institutions: Directorate-General for Environment, European Commission
Subjects: chemical product, chemicals legislation, classification, dangerous substance, environmental protection, labelling, packaging, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 19.12.2022  SWD(2022) 434 final  COMMISSION STAFF WORKING DOCUMENT   Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures {COM(2022) 748 final} - {SEC(2022) 452 final} - {SWD(2022) 435 final} - {SWD(2022) 436 final}  
 
 
Subsidiarity Grid 

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? 

This proposal has the aim of further ensuring the functioning of the internal market, taking as a base 
a high level of health, environmental and consumer protection. Hence, its legal basis is Article 114 of 
the Treaty on the Functioning of the European Union (‘TFEU’).  

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

In the case of internal market, the Union competence is shared according to Article 4(2) TFEU.  

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? 

The  proposal  fulfils  the  procedure  requirements  of  Protocol  No.  2  given  that  there  were  wide 
consultations  of  all  types  of  stakeholders  at  Union,  national  and  regional  level  as  well  as  public 
authorities, before proposing the act.  

Initial  feedback  was  provided  on  the  inception  impact  assessment  published  on  the  Commission’s 
‘Have Your Say’ website.5 The feedback period ran from 4 May 2021 until 1 June 2021, and got 182 
comments.  

As  part  of  the  impact  assessment,  an  open  public  consultation  (OPC)  on  the  revision  of  the  CLP 
Regulation ran for 14 weeks from 9 August 2021 to 15 November 2021.6 The questionnaire was split 

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  
5 
chemicals, available at: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12975-
Revision-of-EU-legislation-on-hazard-classification-labelling-and-packaging-of-
chemicals/feedback_en?p_id=24338728. 

European Commission, Revision of EU legislation on hazard classification, labelling and packaging of 

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into  two  sections,  one  containing  11  questions  for  the  general  public,  and  one  containing  37 
questions for experts in the  subject matter. Both sections allowed respondents to provide position 
papers.  

The  consultation  was  followed  by  a  targeted  stakeholder  survey  (TSS).  The  survey  was  open  for 6 
weeks  (from  10  November to  22  December  2021).  A  stakeholder  mapping  exercise  identified  548 
stakeholders, to whom the survey was sent.  

Furthermore, extensive discussions on specific issues of the revision of the CLP Regulation were held 
in  3  ad  hoc  meetings  of  the  relevant  expert  group,  the  Competent  Authorities  for  REACH  and  CLP 
(CARACAL), with wide Member State and stakeholder participation:  

-  CARACAL meeting on Poison Centres and Online Sales (27 October 2021),  
-  CARACAL  meeting  on  Harmonised  Classification  and  Labelling  Prioritisation,  Predicted  No-
Effect  Concentration  (PNEC),  Derived  No-Effect  Level  (DNEL),  Derived  Minimal  Effect  Level 
(DMEL) and Labelling (6 December 2021), 

-  CARACAL meeting  on  New  Hazard  Classes, More  than  One  Constituent  Substances  (MOCS) 

and Self-Classification (14 December 2021).  

Relevant  discussions on  specific  topics covered  by  this  proposal  were  also  held  previously  in other 
CARACAL meetings. 

In addition, 22 interviews were conducted between December 2021 and February 2022 with public 
authorities,  EU  agencies,  companies  and  business  associations,  non-governmental  and  other 
organisations.  Their  purpose  was  to  complement  the  findings  of  the  open  public  consultation,  the 
targeted stakeholder consultation and the views provided by CARACAL members and observers. 

Another  open  public  consultation  on  simplification  and  digitalisation  of  labels  on  chemicals  was 
open for 12 weeks, from 24 November 2021 to 17 February 2022.7 The launch of that consultation 
was  complemented  by  a  stakeholder  workshop  on  simplification  and  digitalisation  of  labelling 
requirements for chemicals, held on 26 November 2021. Additionally, two online surveys, on policy 
options for digitalisation and for information from professionals and industry users, were conducted.  

impact  assessment 
The  explanatory  memorandum  of  the  Commission  proposal  and  the 
accompanying  the  Commission  proposal  contain  a  section  on  the  principle  of  subsidiarity.  These 
sections that concern the principle of subsidiarity are also reproduced in the answer to question 2.2.   

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? 

Yes, those documents contain such a justification.  

European Commission, Revision of EU legislation on hazard classification, labelling and packaging of 

6  
chemicals, available at: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12975-
Revision-of-EU-legislation-on-hazard-classification-labelling-and-packaging-of-chemicals/public-
consultation_en.   
7  
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12992-Chemicals-simplification-
and-digitalisation-of-labelling-requirements/public-consultation_en.  

European Commission, simplification and digitalisation of labelling requirements, available at: 

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The  explanatory  memorandum  mentions  that  “In  the  same  way  as  when  the  CLP  Regulation  was 
adopted,  the  objectives  of  this  proposed  Regulation  cannot  be  sufficiently  achieved  at  Member 
States’  level,  but  can  rather,  by  reason  of  the  scale  or  effects  of  the  proposed  action,  be  better 
achieved at Union level. To solve the same problems, one action at Union level will be less costly and 
more efficient than twenty-seven different actions.  
Action  at  EU  level  is  crucial  to  preserve  free  movement  of  chemicals  in  the  EU’s  internal  market. 
Individual  actions  at  national  level  would  impose  significant  administrative  burdens  on  companies 
seeking access to the market of more than one EU Member State. Furthermore, chemical pollution 
and  its  negative  impacts  are  transboundary  by  nature.  Therefore,  citizens  in  one  Member  State 
would be affected by the potential inaction in another Member State.”.  

More extensively but similarly chapter 3 of the impact assessment describes the necessity and added 
value of Union action.  

It is necessary to act at Union level for the following reasons: 

  Most  problems  (e.g.,  diseases  and  pollution  through  hazardous  substances,  insufficient 
compliance)  result  in  costs  for  society  and  the  general  public  (negative  externalities)  and 
their intensity may vary across the European regions, but they exist everywhere in the EU to 
a  certain  extent;  to  adopt  a  coherent  approach  tackling  such  problems,  EU  action  is 
necessary;  

  Most  problems  are  transboundary  in  nature,  or  even  have  an  international  dimension  and 
touch  upon  customs  related  matters,  which  cannot  be  sufficiently  addressed  by  single 
Member  States  in  isolation.  To  further  improve  the  free  movement  of  substances  and 
mixtures and enable an even better functioning internal market, Member States cannot act 
alone, they need an overarching framework regulating such movement;  

  Apart from different enforcement levels in the Member States, the problem drivers are the 

same, so that EU action addresses the problem drivers best; 

  Certain Member States have already initiated national actions to address the issue of missing 
hazard  classes  before  waiting  for  any  EU  action  on  the  matter;  this  could  lead  to  the 
undesirable  effect  of  heavily  fragmenting  the  internal  market.  Also,  Member  States’ 
behaviour would not seem to be fully in line with the Treaty rules providing for  the general 
principle  that  Member  States  shall  not  exercise  their  competence  if  the  Union  did  already 
(I.e.  to  the  extent  that  the  Union  has  used  its  ‘right  of  pre-emption'8).  EU  action  would 
therefore make the overall system more coherent.  

Regarding  the  added  value  of  EU  action,  one  action  at  Union  level  will  be  less  costly  and  more 
efficient than twenty-seven different actions to solve the same problems (economies of scale exist), 
and therefore EU action brings added value. CLP replaced different national policies harmonising the 
rules  at  EU  level,  which  has  proven  to  be  a  success.  EU  action  would  aim  at  addressing  the 
shortcomings of an already existing framework which will help achieving the objectives of CLP.  

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

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

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

tackled? Have these been quantified? 

Most problems identified in the impact assessment are indeed transboundary in nature (e.g. 

8 Article 2(2) TFEU.  

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diseases  and  pollution  through  hazardous  chemicals,  sub-optimal  hazard  communication, 
sub-optimal  notifications  to  poison  centres,  online  sales  from  non-EU  actors).  Those 
problems  and  their  impacts  were  quantified  and,  if  impossible,  a  qualitative  analysis  was 
carried out.   

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

the Treaty9 or significantly damage the interests of other Member States? 

Yes, this would be the case, as a continued divergence of measures taken by Member States 
would  disrupt  the  functioning  of  the  internal  market  and  would  lead  to  different  levels  of 
protection  of  health  and  environment,  even  more  considering  that  the  CLP  Regulation 
framework exists already.  

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

measures? 

The Treaty establishes the obligation that Member States shall exercise their competence to 
the extent that the Union has not exercised its competence (Article 2(2) TFEU); by adopting 
the CLP Regulation in 2008 the Union has exercised its competence in the field.  

In this framework, the proposal does not make it possible for Member States to deviate from 
its provisions. On the other hand, the proposal gives some additional possibilities to Member 
States,  including  the  possibility  to  submit  dossiers  for  harmonised  toxicity  values  and  the 
option  to  nominate  the  European  Chemicals  Agency  as  appointed  body  responsible  for 
receiving the information required to provide adequate emergency health response. 

(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? 

Although the  problem and its  causes  may  (slightly)  vary  between the Member States,  they 
exist everywhere in the EU to a certain extent.  

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

There are different problems to be tackled (problems related to hazard identification, hazard 
communication and compliance), but they are spread overall the EU and certainly not limited 
to a few specific Member States.  

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

Yes,  Member  States  are  overstretched,  since,  in  the  absence  of  this  initiative,  the  national 
actions that have been and would further be initiated by Member States to address some of 
the identified problems would not be able to achieve the objectives  and would require a lot 
more  resources,  which  are  unavailable,  than  the  resources  needed  in  the  framework  of 
harmonised action.   

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

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

differ across the EU? 

There  exist  huge  differences  in  available  financial  resources  of  public  authorities  how  to 
tackle certain identified problems, but public authorities are of the uniform view that further 
action  is  needed  and  an  agreement  exists  to  a  large  extent  about  the  direction  of  the 
proposed measures. Ultimately better hazard identification and communication will lead to 
better  risk  management  of  chemicals;  hence  this  targeted  revision  is  the  right  step  in  this 
direction.  

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)? 

Yes, the objectives can be better achieved at Union level given that there is clear added value from 
EU  level  action,  economies  of  scale  exist  and  they  are  more  effective,  the  internal  market  will  be 
strengthened  by  further  harmonising  regulatory  requirements  and  by  further  clarifying  legal 
provisions without taking away any competences from Member States other than the ones already 
transferred to the Union.  

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

Yes,  there  is  added  value  from  EU  level  action.  Action  at  EU  level  is  crucial  in  order  to 
preserve free movement of chemicals in the single market. Different actions at national level 
would  impose  additional  administrative  burdens  on  large  and  SME  operators.  In  addition, 
chemical  pollution  and  societal  costs  are  transboundary  in  nature,  and  diverging  actions 
would lead to health and environmental impacts that could have been avoided. 

(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? 

Yes, economies of scale exist and objectives are more efficiently met at EU level. This is the 
case, for example, for multilingual fold-out labels or for the potential nomination by Member 
States  of  ECHA  as  the  appropriate  body  for  emergency  health  response  information.  The 
functioning of the internal market will be improved, as a result of the clarification of various 
legal  provisions,  of  the  digital  labelling  possibilities,  of  improving  submissions  to  poison 
centres, and of the increased level of compliance.  

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

homogenous policy approach? 

The area is already harmonised. This revision builds on this prior harmonisation.  

(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)? 

Since  the  area  is  already  harmonised,  Member  States  will  neither  gain  nor  lose  any 
competence. The benefits of EU level action by means of the adoption of the CLP Regulation, 

5 

 
 
 
 
 
have already outweighed the loss of competence of the Member States in this area. 

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

Yes, improving legal clarity is an aim of this targeted revision. This is especially addressed in 
relation  to  the  provisions  on  online  sales,  notifications  to  poison  centres,  labelling  of 
containers of refill chemicals, but also other provisions. 

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 explanatory memorandum mentions that the initiative does not go beyond what is necessary to 
achieve the objectives sought. 

The  supporting  impact  assessment10  assesses  the  impacts  of  the  proposed  revision  of  the  CLP 
Regulation. Both qualitative and quantitative assessment have been undertaken that show that the 
proposal is proportionate, i.e. that environmental and societal benefits are significantly higher than 
the costs incurred. 

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? 

This proposal is an appropriate way to achieve the intended objectives given that they can be better 
achieved  at  Union  rather  than  at  national  level,  while  divergent  national  action  would  also  risk 
impeding the functioning of the internal market and the effective protection of the environment and 
health. Moreover, the proposal does not go beyond what is necessary to achieve the set objectives, 
the chosen legal instrument revises and complements the already applicable one (a Regulation) and 
is therefore the most  effective  and simplest way forward, a common action entails significant  cost 
savings, and specific circumstances in certain Member States were duly taken into account.  

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

their own, and where the Union can do better? 

Yes,  the  initiative  is  limited  to  those  aspects  that  the  Member  States  cannot  achieve  as 
effectively  on  their  own  and  where  divergent  national  measures  would  risk  distorting  the 
functioning  of  the 
internal  market  and  preventing  the  effective  protection  of  the 
environment and human health. Therefore, the intended objectives can be better achieved 
at Union level. 

(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 

10  

Impact Assessment Report; Executive Summary of the Impact Assessment Report  

6 

 
 
 
 
 
                                                           
pursued  (e.g.  choice  between  regulation,  (framework)  directive,  recommendation,  or 
alternative regulatory methods such as co-legislation, etc.)? 

The targeted revision builds on the already applicable legal instrument, i.e. a Regulation, and 
proposes to amend that Regulation. This way forward is the most simple and effective way of 
achieving the said policy objectives.  

(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?) 

The proposed Union action does not go beyond what is necessary to achieve the objectives. 
The  legal  instrument  of  a  regulation  ensures  direct  applicability,  uniform  application  and 
uniform enforcement throughout the EU, which would not be possible in case of adoption of 
minimum standards by means of a directive. A less stringent policy instrument (e.g. also if it 
was decided to address the identified problems via guidance instead of by directly amending 
the legislation) would not be sufficient to achieve the said objectives.  

(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 initiative creates financial or administrative costs as well as costs for economic operators 
and  citizens  which  can  be  better  borne  at  EU  level  for  27  Member  States  than  by  each 
Member  State  alone  (see  also  previous  replies  referring  to  savings  due  to  economies  of 
scale).  However,  those  costs  are  commensurate  with  the  objectives  set  and  the  benefits 
outweigh  the  costs  (especially  for  society  and  the  environment).  The  costs  must  also  be 
compared to the costs of a decline in the level of protection of health and environment due 
to inaction. 

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

States been taken into account? 

As  already  mentioned,  the  Commission  consulted  stakeholders  and  authorities  widely  and 
any issues raised that concern individual Member States or certain regions were duly taken 
into account. More specifically, some concerns expressed with regard to potential decreased 
demand  for  chemical  products  produced  in  specific  regions,  due  to  their  potential 
harmonised classification in line with the new hazard classes, were not considered sufficient 
to  challenge  the  proportionality  of  the  latter  measure  and  its  necessity  to  address  the 
objectives set by this initiative. 

7