COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT 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

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  EN 

   EUROPEAN COMMISSION  Brussels, 19.12.2022  SWD(2022) 436 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  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) 434 final} - {SWD(2022) 435 final}  
 
 
A. Need for action 

What is the problem and why is it a problem at EU level?  

The  problem  addressed  by  the  initiative  is  that  the  current  version  of  the  CLP  Regulation 
insufficiently  protects  humans  and  the  environment  from  intrinsic  hazards  of  certain 
chemicals  moving  freely  within  the  EU’s  single  market.  This  problem  manifests  itself  in 
three areas:  

for  chemicals 

1.  Hazardous chemicals are not comprehensively identified and classified. That is true in 
(‘ED’),  persistent, 
particular 
bioaccumulative and toxic (‘PBT’), very persistent and very bioaccumulative (‘vPvB’), 
persistent,  mobile  and  toxic  (‘PMT’),  or  very  persistent  and  very  mobile  (‘vPvM’) 
properties, since there is currently no duty to systematically examine and classify such 
properties.  

that  have  endocrine  disrupting 

2.  Member  State  Competent  Authorities  and  the  European  Chemicals  Agency  (‘ECHA’) 
operate on the limit of their resources to prepare proposals (in the case of Member State 
Competent  Authorities)  and  Opinions  (in  the  case  of  ECHA)  for  harmonised 
classification  and  labelling  of  substances.  As  a  consequence,  they  do  not  have  the 
optimal  tools  to  implement  homogenous  risk  management  measures  for  all  hazardous 
chemicals. It also risks fragmenting the single market and un-levelling the playing field 
for companies operating on it. 

3.  The  communication  on  chemical  hazards  is  sub-optimal,  which  results  in  a  lack  of 
knowledge  on  hazardous  properties  of  chemicals.  This  leads  to  a  situation  where 
consumers  and  businesses  cannot  base  their  purchase  decisions  on  robust  knowledge 
that  enables  them  to  minimise  environmental  and  health  risks,  leading  to  potential 
exposure  of  consumers,  workers  and  the  environment  to  unnecessary  risks.  There  is  a 
high  level  of  non-compliance  with  the  CLP  obligations  in  the  context  of  e-commerce 
Information  on  hazardous  mixtures  submitted  to  poison  centres  for  their  emergency 
health response is insufficient in certain cases.  

What should be achieved? 

The three main objectives are:  

1.  To  ensure  that  critically  hazardous  chemicals,  including  those  with  ED,  PBT,  vPvB, 
PMT and vPvM properties, are classified adequately and homogenously throughout the 
EU; 

2.  To  make  chemical  hazard  communication  simpler  for  economic  operators  and  more 

accessible and understandable for users of chemicals; and  

3.  To make sure that the rules on chemicals hazard classification and communication are 

applied equally by all relevant actors in the supply chain.  

What is the value added of action at the EU level (subsidiarity)?  

Action at EU level is crucial to preserve free movement of chemicals on the single market. 

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Different  actions  at  national  level  would  impose  additional  administrative  burdens  on  large 
operators  and  SMEs,  obstructing  free  movement.  Furthermore,  chemical  pollution  is 
transboundary in nature and societal costs negatively impact the EU wellbeing and economy. 
Inaction in one Member State leads to costs in others.  

B. Solutions 

What are the various options to achieve the objectives? Is there a preferred option? 

Based  on  evaluations  of  existing  legislation  and  stakeholder  input,  a  comprehensive  list  of 
potential  measures  was  created.  Following  initial  screening,  22  measures  were  retained  for 
in-depth  assessment.  In  the  end,  17  preferred  measures  were  bundled  into  3  independent 
policy options, corresponding to each of the 3 identified problem areas: 

1. Adequate classification of critically hazardous chemicals will be ensured by:  

-  introducing  ED,  PBT,  vPvB,  PMT  and  vPvM  as  new  hazard  classes  in  the  CLP 
Regulation and prioritising them for harmonised classification; 
- publishing the reasons for diverging notified self-classifications in ECHA’s classification 
and labelling inventory, along with the names of the notifiers;  
- requiring updates of notifications of self-classifications within a certain deadline;  
- reinforcing prioritisation for harmonised classification at an early stage; and 
-  allowing  the  Commission  to  initiate  and  fund  more  harmonised  classification  and 
labelling dossiers, including by mandate to ECHA. 

2. Improvement of hazard communication will be ensured by:  

-  explicitly  addressing  the  concept  of  refill  sales  with  some  derogations  from  labelling 
obligations and limiting this practice to mild hazards only;  
- increasing readability of CLP labels by regulating label formatting;  
-  allowing  some  supplemental  information  that  is  not  obligatory  under  UN  GHS  to  go 
digital where their physical availability on the label is not instrumental for the protection 
of  human  health  and  the  environment  and  creating  a  framework  for  further  digital 
labelling of this information;  
- allowing broader use of fold-out labels for chemicals traded in several EU countries; and 
- providing derogation to labelling requirements for chemicals sold to consumers in  bulk 
(e.g., fuel) and very small packaging (e.g., writing instruments). 

3. Addressing main legal gaps and ambiguities will be insured by:  

- clarifying rules for online offerings and advertising;  
- reinforcing the obligation on a responsible economic actor for online sales to comply 
with the requirements of CLP; and 
- introducing targeted obligations for notification to poison centres in case of information 
loss, e.g., when chemicals move between Member States or are re-labelled. 

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The above options were preferred over the following discarded ones:  

Firstly, regarding hazard classification, the policy option to introduce harmonised human and 
environmental  reference  values  for  toxicity.  While  such  values  are  useful,  CLP  cannot 
provide  for  their  use  in  other  chemical  legislation,  which  would  result  in  additional  costs, 
little  added  value.  Moreover,  there  was  little  support  for  such  measure  during  public 
consultation.  By  contrast,  the  preferred  options  complement  each  other,  tackle  different 
drivers  of  the  problem  at  hand  and  counterbalance  the  additional  costs  by  additional  added 
value. 

Secondly,  the  policy  option  calling  for  an  update  piece  of  guidance  to  clarify  the  CLP 
obligations  concerning  chemicals  sold  in  very  small  packaging,  in  bulk  and  via  refill 
containers  does  not  sufficiently  address  the  problem.  As  the  legal  text  itself  lacks  clarity, 
guidance does not have same legal value as a clarified legal text.  

Thirdly,  the  policy  option  to  run  periodic  awareness  campaigns  on  the  display  of  labelling 
elements online. This option is less effective, as consumers might not remember the content 
of  awareness  campaigns  when  buying  online,  than  setting  rules  on  online  offerings  and 
reinforcing rules  on online advertisings and  reinforcing the need of a responsible  economic 
actor  in  the  supply  chain.  As  for  the  poison  centre-notifications,  the  mutually  exclusive 
measures  of  full  notifications  to  poison  centres  by  all  actors  in  the  supply  chain  and 
notifications  to  poison  centres  by  re-branders  and  re-labellers  were  discarded  in  favour  of 
targeted notification obligations. The latter has the best cost to operators - social benefit ratio, 
since it prevents multiple cases of information loss without obliging all distributors to notify 
by default.  

What are different stakeholders' views? Who supports which option?  

The  introduction  in  the  CLP  Regulation  of  new  hazard  classes  is  generally  strongly 
supported. The EU industry indicated a strong preference, however, for the EU to propose the 
new hazard classes first at UN level before introducing them in EU legislation. Stakeholders 
also generally welcome the strengthening of the system for harmonised classification, albeit 
warning of the resource implications.  

Stakeholders  generally  welcome  the  new  possibilities  offered  by  increased  use  of  foldout 
labels  and  the  regulation  of  refill  sales,  replying  that  it  would  ease  the  burden  for  SMEs. 
Certain  concerns  are  expressed  about  the  digital  divide,  but  it  is  generally  accepted  that  a 
limited set of information could be provided by digital means only. Strengthening the rules 
for online sales received strong and unanimous support from  all categories of stakeholders. 
The  extension  to  certain  economic  operators  of  the  obligation  to  notify  poison  centres  of 
chemicals is also generally welcomed.  

C. Impacts of the preferred option 

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What are the benefits of the preferred option?  

The  benefits  of  the  preferred  option  stem  mainly  from  improvement  of  the  protection  of 
health and the environment. Savings to public health systems and depollution schemes could 
amount  to  more  than  EUR  300  million  per  year.  Adequate  and  homogenous  hazard 
classification  allows  chemicals  suppliers,  users  and  public  authorities  to  take  adequate 
measures to manage chemicals risks while preserving the integrity of the single market and 
levelling  the  playing  field  between  economic  operators.  Improved  communication  on 
chemical  hazards  will  allow  consumers  to  make  informed  choices  and  avoid  unnecessary 
risks  to  health  or  the  environment.  Finally,  simplified  labelling  rules  will  save  costs  for 
businesses.  Closing  legal  gaps  related  to  online  sales  and  poison  centres  will  ensure  better 
compliance ultimately leading to better implementation and easier enforcement.  

What are the costs of the preferred option? 

The  initiative  will  entail  significant  costs  for  industry  actors  placing  chemicals  on  the  EU 
market,  both  administrative  annual  costs  for  compliance  with  the  new  rules  (EUR  28.47 
million) and adjustment costs for voluntary substitution down the supply chain for substances 
which will be covered by the new hazard classes (EUR 26.40 million).  

What are the impacts on SMEs and competitiveness?  

Costs for SMEs will be higher in relative terms, as they benefit less from economies of scale 
and  have  less  capacity  to  absorb  fixed  costs.  New  responsibilities  for  economic  actors 
involved in distance sales, including online sales, from out- or inside the EU will ensure fair 
and equal competition among all businesses selling chemicals, especially for SMEs who sell 
mainly within the EU and rely on online platforms to trade their products.  

The  introduction  of  new  hazard  classes,  while  increasing  costs  on  the  short  term,  will 
translate  into  the  EU  industry  being  the  global  front-runner  in  health  and  environmental 
standards, driving the EU industry’s leadership in producing and using sustainable chemicals, 
and thereby allowing it to increase its competitiveness and global market share.  

The measures  to ensure  homogeneity  of  classification of identical  substances manufactured 
by  different  companies  will  level  the  playing  field  and  contribute  to  fair  competition,  in 
particular  for  SMEs.  SMEs  will  be  able  to  rely  more  on  existing  self-classifications  in  the 
classification and labelling inventory instead of classifying themselves, which is costlier for 
SMEs than it is for large enterprises. 

Will there be significant impacts on national budgets and administrations?  

No. 

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Will there be other significant impacts?  

No. 

Proportionality?  

The initiative does not go beyond what is necessary to achieve its objectives. 

D. Follow up 

When will the policy be reviewed?  

The  impacts  of  the  initiative  will  be  documented  by  the  indicator  framework  for  the 
effectiveness  of  chemicals  legislation  announced  for  2024  by  the  Chemicals  Strategy  for 
Sustainability. The  revised CLP  Regulation  may be (partially) reviewed  once evidence will 
be available under this framework. 

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