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  COM(2022) 748 final 2022/0432 (COD)  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 (Text with EEA relevance) {SEC(2022) 452 final} - {SWD(2022) 434 final} - {SWD(2022) 435 final} - {SWD(2022) 436 final}  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Among its actions, the European Green Deal provides for the strengthening and simplification 
of  the  legal  framework  for  chemicals  to  ensure  a  toxic-free  environment1.  The  revision  of 
Regulation  (EC)  No  1272/2008  on  the  classification,  labelling  and  packaging  of  substances 
and  mixtures  (‘CLP  Regulation’)2  was  announced  by 
the  Chemicals  Strategy  for 
Sustainability3, adopted on 14 October 2020. The targeted revision of the CLP Regulation, as 
part of the strategy, was welcomed by the Council4 and the European Parliament5. 

The  Union  has  overall  been  successful  in  creating  an  efficient  single  market  for  chemicals. 
However,  some  weaknesses  or  gaps  in  the  CLP  Regulation  described  below  prevent 
consumers,  companies,  and  authorities  from  fully  benefiting  from  protection  against  the 
dangers  posed  by  hazardous  chemicals.  As  the  EU  is  committed  to  the  2030  Agenda  for 
Sustainable  Development6  and  its  Sustainable  Development  Goals  (SDGs)7,  this  proposal 
contributes  to  several  of  the  SDGs,  including  those  to  ensure  good  health  and  well-being, 
sustainable consumption and production patterns, and clean water and sanitation8. 

Better identifying and classifying hazardous chemicals  

First,  although  certain  chemicals  and  articles  may  pose  risks  to  human  health  or  to  the 
environment,  their  hazards  are  not  always  properly  identified  and  communicated.  The  main 
driver  behind  this  issue  are  inefficiencies  in  the  procedures  for  assessing  and  classifying 
hazards.  Shortcomings  in  hazard  communication  also  impair  consumers’  ability  to  make 
informed choices. 

Second, there is a high number of erroneous or obsolete classifications of substances, as well 
as  diverging  classifications  for  the  same  substance  in  the  European  Chemical  Agency’s 
classification  and  labelling  inventory  (‘inventory),  with  almost  60%  of  companies  having 
multiple  notified  classifications  for  a  single  substance9.  The  issue  of  erroneous,  obsolete 
and/or diverging classification leads to information deficiencies for users of chemicals, which 
may increase their exposure to those chemicals. 

As  part  of  the  CLP  Regulation  revision  package,  a  delegated  act  will  add  definitions  and 
scientific  and  technical  criteria  to  enable  substances  and  mixtures  that  have  endocrine 

1 

2 

3 

4 
5 

6 
7 
8 

9 

The  European  Green  Deal,  Communication  from  the  Commission,  Brussels,  11.12.2019,  p.  15 
(COM(2019) 640 final). 
European Commission, Revision of EU legislation on hazard classification, labelling and packaging of 
chemicals. 
Chemicals  Strategy  for  Sustainability,  Communication  from  the  Commission,  Brussels,  14.10.2020 
(COM(2020) 667 final). 
Council Conclusions on Sustainable Chemicals Strategy of the Union, 2021. 
European  Parliament,  Resolution  of  10  July  2020  on  the  Chemicals  Strategy  for  Sustainability,  2020 
(2020/2531(RSP)). 
https://www.un.org/ga/search/view_doc.asp?symbol=A/RES/70/1&Lang=E.  
https://sdgs.un.org/goals.  
SDG #3 Good health and well-being, SDG #6 Clean water and sanitation, SDG #9 Industry, innovation 
and infrastructure, and SDG #12 Ensure sustainable consumption and production patterns. 
Amec Foster Wheeler et al.,  A Study to gather insights on the drivers, barriers, costs and benefits for 
updating REACH registration and CLP notification dossiers, 2017. 

EN 

1 

  EN 

                                                 
disrupting  (‘ED’),  persistent,  bioaccumulative  and  toxic  (‘PBT’),  very  persistent  and  very 
bioaccumulative (‘vPvB’), persistent, mobile and toxic (‘PMT’), or very persistent and very 
mobile  (‘vPvM’)  properties  to  be  classified  into  established  hazard  classes.    The  impact  of 
adding these new hazard classes has been assessed as part of the overall impact assessment on 
the revision of the CLP Regulation10. 

Improving communication on chemical hazards  

Appropriate  hazard  classification  determines,  among  others,  the  appropriate  labelling  and 
packaging  of  the  chemicals  in  the  supply  chain,  in  particular  to  protect  workers,  consumers 
and the environment, but also to enable the single market to function properly. An estimated 
55%  of  EU  citizens  consider  themselves  not  well  informed  about  the  potential  hazards  of 
chemicals in consumer products11. This is also due to a relatively low level of understanding 
of certain pictograms, labels and warnings, not least due to the limited readability of labels, 
detailed information, technical language and often too small font size. This proposal aims to 
make labelling more consumer friendly, less burdensome for suppliers and easier to enforce 
by clarifying rules and providing clear exemptions. To this end, it will clarify the concept of 
refill sales and introduce provisions to facilitate the use of fold-out labels as well as provisions 
for  minimum  formatting  rules  to  make  labels  more  readable  for  consumers.  In  addition, 
certain  labelling exemptions are provided for chemicals  supplied without packaging such as 
fuel at filling stations, chemicals contained in very small packaging such as pens below 10 ml, 
chemicals with mild hazards supplied in bulk, and ammunition under specific conditions.  

Addressing legal gaps and high levels of non-compliance  

The Chemicals Strategy for Sustainability identifies imported chemicals and online sales as a 
particular challenge and priority area for action. Many chemicals12 sold online in the EU, and 
especially those sold by actors established outside  the EU  and placed on the EU market, do 
not  meet  the  legal  requirements13.  Incorrectly  classified  and  incorrectly  labelled  chemicals 
result in consumers not being properly informed about the hazards, which ultimately leads to 
incorrect  use,  storage  or  disposal.  To  achieve  the  objectives  of  consumer  protection  and 
protection  of  human  health  and  of  the  environment,  and  to  ensure  compliance  with  the 
requirements  of  the  CLP  Regulation  within  the  EU,  the  CLP  Regulation  will  introduce  a 
requirement  that  suppliers  have  to  ensure  that  substances  or  mixtures,  including  those  sold 
online  via  distance  sales,  meet  the  requirements  of  CLP,  in  particular  on  classification, 
labelling  and  packaging.  In  addition,  online  offers  and  advertisements  often  do  not  display 
hazard  information,  therefore,  consumers  may  not  be  able  to  make  informed  choices  at  the 
moment  of  accepting  the  online  offer  or  when  following  up  on  the  advertised  chemical. 
Chemicals’  labelling  information  should  be  made  available  before  placing  on  the  market, 
regardless of the means of sale.  

10 

11 
12 

13 

Commission  Staff  Working  Document  –  Impact  Assessment  Report  Accompanying  the  document 
Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  amending  Regulation  (EC) 
1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of 
substances and of mixtures (‘Impact Assessment Report’), (not yet published), p. 34. 
2017 Special Eurobarometer 468.  
Rate of non-compliance with CLP provisions was 75% of 2,752 inspected products in 29 EEA countries 
and  82.4%  of  1,314  inspected  products  in  15  EU  countries;  Non-compliant  with  Article  48(2)  on 
advertisement of mixtures, ECHA, Final report on the Forum Pilot Project on CLP focusing on control 
of internet sales, 2018. 
KEMI, Increased e-commerce – increased chemicals risks? A mapping of the challenges of e-commerce 
and proposed measures. Report of a government assignment, 2021. 

EN 

2 

  EN 

                                                 
Another provision leading to legal ambiguities relates to the notifications that companies must 
submit  to  poison  centres  for  emergency  health  response.  It  is  essential  that  poison  centres, 
when  answering  emergency  calls,  have  all  the  necessary  information  on  the  composition  of 
mixtures  so  they  can  provide  clear  advice  to  consumers  or  health  professionals.  While  the 
CLP  Regulation  provides  for  the  obligation  for  downstream  users  and  importers  to  submit 
relevant  information  for  emergency  health  response,  it  does  not  explicitly  do  so  for 
distributors either supplying those mixtures across borders or rebranding or relabelling them. 
An  explicit  obligation  to  do  so  would  close  the  loop  of  loss  of  information  submitted  to 
poison centres. 

Conclusion 

The three problems  outlined above highlight  why the  current  legislation fails to  sufficiently 
protect humans and the environment from the hazards of chemicals moving freely within the 
EU single market and why modifications are needed to facilitate enforcement.  

The CLP Regulation revision package therefore aims to: 

(i) 

(ii) 

ensure  that  all  hazardous  chemicals,  including  those  with  ED,  PBT,  vPvB, 
PMT and vPvM properties, are classified adequately and uniformly throughout 
the EU; 

improve  the  efficiency  of  hazard  communication  by  making  labels  more 
accessible  and  understandable  for  users  of  chemicals,  and  provide  companies 
with  more  flexibility,  thereby  reducing  the  administrative  burden  without 
lowering safety levels; 

(iii)  make sure that the rules on chemical hazard classification and communication 

are applied by all relevant actors in the supply chain. 

• 

Consistency with existing policy provisions in the policy area 

The  delegated  act  referred  to  above  complements  the  present  proposal  by  introducing  into 
Annex  I to  the CLP Regulation  new hazard classes and corresponding classification criteria 
for substances and mixtures with ED properties for human health and for the environment, as 
well  as  PBT,  vPvB,  PMT  and  vPvM  properties.  The  proposed  provision  in  this  proposal  to 
prioritise the above-mentioned hazard classes for harmonised classification will help achieve 
the European Green Deal’s vision of a toxic-free environment. 

The Chemicals Strategy for Sustainability calls for the Registration, Evaluation, Authorisation 
and Restriction of Chemicals Regulation (REACH)14 and the CLP Regulation to be reinforced 
as the cornerstones for regulating chemicals in the EU. They should also be complemented by 
coherent  approaches  to  assess  and  manage  chemicals  in  existing  sectoral  legislation, 
especially  in  relation  to  consumer  products.  The  CLP  Regulation  focuses  on  classifying 
chemicals  that  are  hazardous,  i.e.  which  have  adverse  effects  on  human  health  or  the 
environment  or  adverse  physical  effects,  and  on  communicating  them  to  users  of  chemicals 
and decision makers (consumers, industry and authorities).  

14 

Regulation (EC) No 1907/2006 of the  European Parliament and of the Council of 18 December 2006 
concerning  the  registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1). 

EN 

3 

  EN 

                                                 
Under the CLP Regulation, the decision to classify a substance or a mixture for environmental 
and human health hazards is exclusively based on existing information. The need to generate 
any  additional  data  requirements  is  regulated  by  REACH.  As  part  of  ongoing  revision  of 
REACH, a possible extension of data requirements  for ED identification  and for substances 
placed on the market in lower volumes is being assessed. These data would be made available 
for classification, thus further improving how these two regulations work together. 

An  extension  of  the  generic  approach  to  risk  management  –  which  relies  on  harmonised 
classification  as  a  starting  basis  –  is  currently  under  review  under  REACH  and  product 
legislation  (e.g.  cosmetics,  toys,  food  contact  materials).  Legislation  based  on  pre-market 
authorisations15, such as  plant protection products16 and biocides legislation17, also  relies on 
harmonised  classification.  Those  revisions  will  very  likely  increase  the  reliance  on 
harmonised classifications, so that appropriate risk management measures can be adopted.   

Several  other  policy  initiatives  under  the  European  Green  Deal  will  ensure  that  consumers 
have  access  to  updated  information  on  the  impact  of  consumer  products  on  human  health 
and/or  the  environment.  The  Ecodesign  for  Sustainable  Products  Regulation  proposal18 
introduces  provisions  to  regulate  consumer  products  on  several  sustainability  aspects. 
However,  chemical  safety  is  excluded  from  its  scope.  This  revision  proposal  therefore 
complements  the  Ecodesign  for  Sustainable  Products  Regulation  proposal  in  terms  of 
consumer access to information on the dangers of chemicals present in products. The proposal 
also  improves  the  provision  of  product  information  via  digital  tools,  in  particular  a  digital 
product  passport  that  will  gather  data  on  a  product  and  its  value  chain.  This  passport  is 
particularly  relevant  for  the  introduction  of  digital  labelling  because  it  provides  for  the 
mandatory  adoption  of  digital  ways  for  communicating  product  information.  However,  the 
overarching principle that guides what information could be moved to an online label will be 
to ensure that any information directly linked to user safety and environment protection – and 
not  somehow overlapping, redundant  or of little added value  –  is  kept  on the physical  label 
that is accessible under all circumstances.  

• 

Consistency with other Union policies 

The  CLP  Regulation  plays  a  central  role  in  hazard  classification  and  communication.19 
Revising  it  also  contributes  to  the  realisation  of  the  EU’s  zero  pollution  vision  for  2050  by 
better managing chemicals’ risks in products (including imports) and combination effects of 
different chemicals.  

Furthermore,  this  proposal  is  fully  aligned  with  the  EU’s  climate  objective  to  avoid  and 
reduce greenhouse gas emissions. While relabelling (recalling chemicals in the supply chain 
to  label  and  ship  them  again  –  cost  that  is  tempered  by  the  transitional  provisions  allowing 

15 
16 

17 

18 

19 

Whereby placing on the EU market is conditional upon receiving authorisation to do so. 
Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  of  21  October  2009 
concerning  the  placing  of  plant  protection  products  on  the  market  and  repealing  Council  Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 
Regulation  (EU)  No  528/2012  of  22  May  2012 of  the  European  Parliament  and  of  the  Council 
concerning  the  making  available  on  the  market  and  use  of  biocidal  products  (OJ  L  167  of  27.6.2012 
p.1). 
Proposal for a Regulation of the European Parliament and of the Council establishing a framework for 
setting  ecodesign  requirements  for  sustainable  products  and  repealing  Directive  2009/125/EC, 
COM(2022) 142 final. 
Chemicals Strategy for Sustainability, Communication from the  Commission, Brussels, 14.10.2020, p. 
9 and 16, (COM(2020) 667 final). 

EN 

4 

  EN 

                                                 
substances and mixtures already placed on the market at the date of application not to be re-
labelled)  and  the  voluntary  substitution  of  chemicals  may  generate  some  greenhouse  gas 
emissions,  the  overall  benefit  of  contributing  to  an  environment  more  resilient  to  climate 
changes by identifying and reducing hazardous substances has a balancing effect20. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

This  proposal  has  as  its  legal  basis  Article  114  of  the  Treaty  on  the  Functioning  of  the 
European Union. 

• 

Subsidiarity (for non-exclusive competence)  

In  the  same  way  as  when  the  CLP  Regulation  was  adopted,  the  objectives  of  this  proposed 
Regulation cannot be sufficiently achieved at Member State level. Given the scale or effects 
of the proposed action, they can be better achieved at EU level. To solve the same problems, 
one action at EU level will be less costly and more efficient than 27 different actions.  

Action at EU level is crucial to preserve the free movement of chemicals in the single 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.  Citizens  in  one 
Member State would therefore be affected by the potential inaction in another Member State. 

• 

Proportionality 

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

The supporting impact assessment21 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  is  that  environmental  and  societal  benefits  are 
significantly higher than the costs incurred. 

• 

Choice of the instrument 

This proposal for revision is a legislative proposal. The CLP Regulation has been adopted by 
co-decision and therefore its revision needs to be adopted by ordinary legislative procedure. It 
maintains the choice of instrument as a directly applicable and binding EU Regulation. While 
the Annexes to the CLP Regulation have been amended several times before, this proposal is 
a targeted revision of the enacting terms and, where relevant, the related Annexes. Although 
the  CLP  Regulation  has  empowered  the  Commission  to  amend  certain  Articles  of  the  CLP 
Regulation  and  the Annexes  to  adapt  them to  technical  and scientific progress,  a number of 
amendments to these Articles and Annexes are included in this legislative proposal to ease the 
adoption process as they are linked to the amended provisions which refer to them.  

20 
21 

Impact Assessment Report, p. 46; Annex to the Impact Assessment Report, p. 147. 
Impact Assessment Report; Executive Summary of the Impact Assessment Report  

EN 

5 

  EN 

                                                 
3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

• 
The CLP Regulation, together with  other pieces  of EU legislation, was  evaluated in  201922. 
The fitness check’s overall conclusion was that EU chemicals legislation, including the CLP 
Regulation, meets the objectives. The added value of policy action at the EU level is high and 
remains relevant.  Significant  benefits  in  terms  of avoided health and environmental impacts 
(healthcare costs, productivity losses, suffering and premature deaths, remediation costs, and 
degradation  of  environmental/eco-system  services)  were  registered.  At  the  same  time,  the 
fitness check identified some significant issues and weaknesses that hold the CLP Regulation 
back  from  delivering  its  full  potential.  The  evaluation  pinpointed  potential  areas  of 
intervention:  

 

 

 

 

 

 

 

 

providing harmonised reference values in addition to harmonised classification; 

improving harmonised classification; 

improving and streamlining industry’s classification; 

clarifying rules on hazard labelling; 

reviewing  the  exemption  of  certain  chemical  products  from  the  CLP 
Regulation; 

addressing the low compliance rate with labelling  requirements for the online 
selling of chemicals; 

closing notification gaps for poison centres; 

improving  data  quality  in  the  European  Chemicals  Agency’s  (‘the  Agency’) 
inventory. 

• 

Stakeholder consultations 

Initial  feedback  was  provided  on  the  inception  impact  assessment  published  on  the 
Commission’s  ‘Have  Your  Say’  website23.  The  feedback  period  ran  from  4  May  2021  to 
1 June 2021, with 182 comments.  

As  part  of  the  impact  assessment,  an  open  public  consultation  on  the  revision  of  the  CLP 
Regulation ran for 14 weeks from 9 August 2021 to 15 November 202124. The questionnaire 
was  split  into  two  sections,  one  containing  11  questions  for  the  general  public,  and  one 
containing  37  questions  for  experts.  Both  sections  allowed  respondents  to  provide  position 
papers.  

22 

23 

24 

Commission  Staff  Working  Document,  Fitness  Check  of  the  most  relevant  chemicals  legislation 
(excluding  REACH),  as  well  as  related  aspects  of  legislation  applied  to  downstream  industries, 
SWD(2019) 199. 
European Commission, Revision of EU legislation on hazard classification, labelling and packaging of 
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 
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.   

EN 

6 

  EN 

                                                 
The consultation was followed by a targeted stakeholder survey. 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 three ad hoc meetings of the CARACAL expert group (Competent Authorities 
for REACH and CLP), with broad 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,  derived  no-effect  level,  derived  minimal  effect 
level and labelling (6 December 2021); 

CARACAL meeting on new hazard classes, more than one constituent substance and 
self-classification (14 December 2021).  

Relevant  discussions  on  specific  topics  covered  by  this  proposal  were  also  held  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 
organisations and other  organisations. The aim  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  202225.  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. Two 
online  surveys,  on  policy  options  for  digitalisation  and  for  information  from  professionals 
and industry users, were also conducted. 

Main input on the problems identified:  

Harmonised  classification  and  labelling:  Most  stakeholders  welcomed  the  measures 
proposed to improve the number of harmonised classification and labelling dossiers, including 
prioritisation  for developing harmonised classifications of substances  raising a high level  of 
concern.  However,  all  stakeholders  pointed  out  that  those  measures  should  not  restrict  the 
Member States’ right of initiative.  

Opinions about providing the Commission with the right to initiate harmonisation processes 
varied,  with  more  respondents  strongly  agreeing  than  disagreeing.  Civil  society,  public 
authorities  and  citizens  were  more  likely  to  strongly  agree  with  this  than  companies  and 
business associations.   

Classification:  Consultees  believe  that  the  Agency  should  be  able  to  remove  incomplete, 
incorrect or obsolete notifications from the inventory after having informed the notifier. It is 
also  important  to  improve  the  Agency’s  digital  tools  for  classification  and  labelling 

25 

European  Commission,  simplification  and  digitalisation  of  labelling  requirements,  available  at: 
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12992-Chemicals-
simplification-and-digitalisation-of-labelling-requirements/public-consultation_en.  

EN 

7 

  EN 

                                                 
notification. 72% of respondents to the open public consultation believe that the obligation to 
agree on an inventory entry should be strengthened.   

Labelling  of  chemical  products  provided  in  small  packages:  companies  and  business 
associations  strongly  supported  derogations  (exemptions)  from  labelling  requirements  for 
these products. They felt that labelling such products is beneficial only when the presence of a 
hazardous substance has a realistic chance of causing harm to users. 

Interviewees consider it beneficial that the selling of refill chemicals is addressed specifically 
in  the  CLP  Regulation,  as  this  sales  method  is  being  used  more  and  more.  In  the  targeted 
stakeholder  survey,  companies  expressed  different  opinions  on  the  labelling  of  chemicals 
sold  in  bulk  to  consumers.  Some  stressed  that  hazards  of  chemicals  sold  in  bulk  to 
consumers (fuels in particular) are not communicated; others emphasised that fuels are sold to 
trained  users  who  buy  them  repeatedly  and  they  supported  derogations  from  labelling 
requirements for substances and mixtures supplied in bulk to consumers. 38% of respondents 
–  digitally  connected  to  reply  to  the  open  public  consultation  that  was  conducted  online  – 
chose  digital  labels  as  the  best  option  for  receiving  information  on  hazards  and  safety 
instructions when buying refill detergents.  

Company  representatives  supported  the  broader  use  of  fold-out  labels  as  they  allow  the 
industry to take advantage of economies of scale, in particular when distributing a chemical in 
Member States with a low population. National authorities explained that featuring multiple 
languages  makes  labels  hard  to  read  at  the  expense  of  communicating  important  safety  and 
hazard information. Consumer associations had similar views on this. They proposed adding 
languages  only  if  there  is  enough  space  left  on  the  label  after  essential  safety  and  hazard 
information has been included in a readable manner.  

Digital  Labelling:  concerns  were  expressed  about  not  all  product  users  having  access  to 
digital information. However, it was generally accepted that a limited set of information could 
be provided by  digital  means only, for example as a complementary hazard communication 
measure.  Public  authorities  were  the  most  likely  to  suggest  that  obligatory  provision  of 
information via digital labelling instead of the traditional label could have significant negative 
health,  safety  and  environmental  impacts.  Representatives  from  all  stakeholder  groups 
considered  that  information  that  is  instrumental  for  the  protection  of  health  and  the 
environment  must  remain  on  the  on-pack  label.  They  especially  indicated  that  the  Unique 
Formula  Identifier,  the  hazard  statement,  the  signal  word,  and  the  hazard  pictogram  should 
remain on the on-pack label.   

Strengthening  the  rules  for  online  sales  received  strong  and  unanimous  support  from  all 
categories  of  stakeholders.  The  overwhelming  majority  of  respondents  agree  that  the  online 
selling  of  chemicals  poses  challenges  and  problems,  in  particular  sales  by  non-EU  traders 
directly  to  consumers  in  the  EU.  They  believe  that  there  is  a  great  need  to  apply  the  same 
obligations under the CLP Regulation (for example labelling, classification and notifications 
to  poison  centres)  to  chemical  products  sold  online,  and  that  the  CLP  Regulation  is  not 
sufficiently  adapted  to  technological  progress  and  societal  developments  when  it  comes  to 
online sales, advertising, offerings and distant contracting.   

Poison  centres:  Stakeholders  welcomed  the  clarification  of  obligations  in  Article  45  and 
recognised  the  problem  of  ambiguous  obligations.  Some  stakeholders  believed  that  the 
problem lies with the diverging interpretation of Article 45 by the Member States, leading to 
specific national requirements. Stakeholders also generally welcomed the clarification of the 

EN 

8 

  EN 

rules for the obligation to notify poison centres of chemicals for some types of companies. On 
adding  notifications  of  substances,  most  respondents  think  that  it  is  not  useful  to  submit 
poison  centres  notifications  on  substances  as  this  information  is  already  available  to  poison 
centres by other means.  

• 

Collection and use of expertise 

In analysing the results of the consultation activities in preparation of this proposal, including 
the open public consultation, targeted stakeholder consultation, interviews and workshops, the 
Commission  has  used  the  services  of  an  external  contractor.  When  assessing  the  range  of 
issues  with  enforcement  of the CLP Regulation’s labelling provisions, the Commission also 
took reports by the Agency into account26. 

• 

Impact assessment 

An impact assessment was carried out, which resulted in a positive opinion with reservations 
from  the  Regulatory  Scrutiny  Board27.  The  Board  concluded  that  the  report  still  contains 
shortcomings,  in  particular  on  the  costs  and  benefits,  the  methodology  used  to  derive  them 
and the justification of the proportionality of the preferred option. The impact assessment has 
been revised to fully address the comments received. 

Based on the evaluations of existing legislation and stakeholder input, a comprehensive list of 
potential measures has been drawn up. Following an initial screening, 22 measures have been 
retained  for  in-depth  assessment.  In  the  end,  17  retained  measures  have  been  bundled  into 
three independent policy options, corresponding to each of the three identified problem areas 
that the revision of the CLP Regulation intends to address. 

Regarding  the  first  problem  on  the  classification  of  chemicals  hazards,  4  options  were 
assessed regarding: 

1.1. 

1.2. 

1.3. 

1.4. 

Inclusion of new hazard classes; 

Consistent classification and improving transparency; 

More and prioritised harmonised classification; 

Complementing hazard identification with hazard quantification. 

Three  options  were  analysed  with  regards  to  the  second  problem  on  the  communication  of 
chemicals hazards:  

1.5. 

1.6. 

1.7. 

New or revised guidance; 

Improving labelling and packaging and making labelling more flexible; 

Digital labelling. 

Finally,  three  options  were  developed  in  response  to  the  third  problem  on  addressing  main 
legal gaps and ambiguities: 

1.8. 

Awareness campaigns; 

26 

27 

ECHA,  REF-6  project  report  -  Classification  and  labelling  of  mixtures,  2019;  ECHA  REF-8  project 
report on enforcement of CLP, REACH and BPR duties related to substances, mixtures and articles sold 
online, 2021.  
Opinion of the Regulatory Scrutiny Board, May 11 2022 (Ref. Ares(2022)3650615 – 13/05/22). 

EN 

9 

  EN 

                                                 
1.9. 

Provisions and clear responsibilities for online sales and imports; 

1.10.  Clarifying provisions for notifications to poison centres. 

The preferred policy option (combining options 1.1, 1.2, 1.3, 2.2, 2.3, 3.2 and 3.3) was chosen 
as it will generate significant and positive health and environmental impacts and incur limited 
negative economic impacts (considering all retained policy options).  

Given  the  very  cross-cutting  nature  of  chemicals,  which  constitute  the  basic  elements  of 
virtually every material and product that we produce and use, the objectives of this initiative 
are closely linked to the other goals of the European Green Deal and the Chemicals Strategy 
for Sustainability, in particular climate neutrality, circularity, biodiversity protection and the 
green  and  digital  transition  of  the  EU  industry.  Those  objectives  also  contribute  to  the 
achievement  of the United Nations Sustainable  Development  Goals  (SDGs), of which 4  are 
directly relevant for chemicals:  

–  SDG #3 Good health  and well-being:  Reduction  of exposure of humans  and the 
environment to hazardous substances as meeting one of the existing hazard classes 
(improvement  of  self  and  harmonised  classifications)  or  new  ones  for  EDs  and 
PMT, vPvM, PBT and vPvB substances. 

–  SDG #6 Clean water and sanitation: Identification of PMT and vPvM substances, 
which  are  difficult  to  remove  from  waste  waters  will  help  to  reducing  the 
pollution of water bodies. 

–  SDG  #9  Industry,  innovation  and  infrastructure:  Setting  criteria  to  identify 
hazardous  substances  and  improving  both  the  self  and  harmonised  classification 
processes  will  allow  the  European  chemical  industry  to  transition  to  more 
sustainable  and  future-proofed  chemicals.  Voluntary  substitutions  of  substances 
classified  as  hazardous  as  such  or  in  mixtures  will  also  foster  innovation  in  the 
chemical industry. 

–  SDG  #12  Ensure  sustainable  consumption  and  production  patterns:  Information 
on chemical hazards will be improved so consumers and users of chemical can not 
only  protect  themselves  better  but  also  make  informed  choices.  Self-refill 
chemicals  will  be  better  regulated  to  allow  only  refill  of  mildly  hazardous 
substances.  When  it  comes  to  online  sales  of  chemicals,  customers  will  have 
access  to  more  comprehensive  information  on  chemical  hazards.  Voluntary 
substitution  of  hazardous  substances  in  mixtures  will  also  help  producing  more 
sustainable chemical products. 

Elements of the legislative proposal 

COMPREHENSIVE IDENTIFICATION AND CLASSIFICATION OF CHEMICAL HAZARDS  

• 

1. 

The first set of amendments consists of five measures aimed at  ensuring the comprehensive 
identification and classification of chemical hazards.  

First,  to  boost  the  efficiency  and  effectiveness  of  the  harmonised  classification  process  and 
complementary to the first measure, harmonised classification for the new hazard classes 
to  be  introduced  by  delegated  act  will  be  prioritised.  This  includes  the  development  of 
prioritisation  criteria  to  guide  the  submission  of  harmonised  classification  and  labelling 
proposals. 

EN 

10 

  EN 

A  second  measure  that  swiftly  boosts  the  development  of  harmonised  classifications  is  to 
allow the Commission to initiate and fund more harmonised classification and labelling 
dossiers, with the possibility to mandate the Agency or the European Food Safety Authority 
(the Authority) to develop a dossier. 

Furthermore,  companies’  classification  of  substances  will  be  improved  as  stronger 
incentives  and  provisions  for  companies  to  appropriately  classify  are  being  introduced 
through  three  measures.  One  of  them  involves  making  available  the  reasons  for  diverging 
notified  classifications  in  the  Agency’s  inventory,  another  one  in  making  the  names  of 
notifiers  public,  while  the  last  measure  requires  updates  of  notifications  of  classifications 
within a certain early stage deadline. 

The  transparency  and  predictability  of  the  proposals  that  the  Member  States,  the 
Commission, manufacturers, importers or downstream  users intend to  submit to the Agency 
will  be  improved  through  an  obligation  for  them  to  communicate  such  intentions  to  the 
Agency.  The  Agency  will  also  be  obliged  to  publish  information  on  such  intentions  and 
update  information  on  the  submitted  proposal  at  each  stage  of  the  procedure  for  the 
harmonisation  of  classification  and  labelling  of  substances.  For  the  same  reason,  a  new 
obligation  will  be  introduced  for  competent  authorities  to  communicate  to  the  Agency  their 
decision  to  accept  or  refuse  a  proposal  for  revision  of  a  harmonised  classification  and 
labelling submitted to  it by a manufacturer, importer or downstream  user.  In the latter case, 
the Agency should share the information with other competent authorities. 

2. 

IMPROVING HAZARD COMMUNICATION  

The second set of amendments consists of five complementary measures.  

First, minimum requirements for hazard communication will be strengthened by introducing 
obligatory  formatting  rules,  such  as  minimum  font  size  and  colour,  to  increase  the 
readability of labels. 

Second,  selling  chemicals  in  refillable  containers  has  the  potential  to  reduce  packaging 
waste. A framework of  specific rules will ensure that this sales method  does not  lead to  an 
increased risk. For this reason, this method will also be limited to chemicals with less severe 
hazards. 

Third, the proposal introduces a general framework to allow for the voluntary digital labelling 
of chemicals. Moreover, the proposal provides that some information can be provided only on 
the  digital  label  and  no  longer  needs  to  be  indicated  on  the  on-pack  label.  As  a  rule,  only 
information that is not instrumental in the protection of health and the environment should be 
moved to the digital label without it being on the on-pack label. In addition, information that 
is obligatory on the on-pack label in accordance with the UN Globally Harmonized System of 
Classification and Labelling of Chemicals will remain on it.  

Fourth, broader use of fold-out labels will be allowed. Advantages in labelling technologies 
allow us to remove certain limitations, enabling companies to take advantage of economies of 
scale. This will also further facilitate the free movement of chemicals in the single market. 

Additional  derogations  will  also  be  introduced  for  chemicals  sold  to  consumers  in  bulk, 
such  as  fuel,  and  in  very  small  packaging,  such  as  various  writing  instruments.  In  these 
cases, there is a limited risk of exposure, whereas adhering to the standard labelling rules is 
sometimes disproportionately expensive or even impossible in practice. 

EN 

11 

  EN 

3. 

ADDRESSING LEGAL GAPS AND AMBIGUITIES OF CLP PROVISIONS  

The  third  set  of  amendments  consists  of  three  complementary  measures  to  address  legal 
gaps and ambiguities in online sales and poison centre notifications.  

First,  provisions  for  distance  sales,  including  online  sales,  and  clear  responsibilities  for  all 
relevant actors will be introduced. To this end, all online sales will require a supplier to ensure 
that  a  substance  or  a  mixture  placed  on  the  EU  market  through  distance  sales  meets  the 
requirements of CLP, in particular on classification, labelling and packaging. The objective is 
to ensure a high level of protection of human health and environment, including by facilitating 
the enforcement of the legislative requirements.  

Second,  the  Digital  Services  Act28  ensures  that  the  providers  of  online  marketplaces  design 
and  organise  their  online  interfaces  in  a  way  that  enables  suppliers  to  comply  with  their 
obligations regarding product safety information under applicable Union law. This is without 
prejudice to the Consumer Rights Directive29. 

Third, the provisions for notifications to poison centres will be clarified. All relevant actors, 
including  distributors  placing 
across  borders  or 
rebranding/relabelling mixtures, will have to make sure that they notify poison centres across 
the EU about the relevant information, where necessary. 

chemicals  on 

the  market 

Health, environmental and economic impacts of the preferred option  

The  proposed  amendments  will  generate  significant  and  positive  health  and  environmental 
impacts  and  will  exert  limited  negative  economic  impacts.  The  benefits  stem  mainly  from 
improvements to the protection of health and the environment, even if the impact assessment 
could not fully quantify them. The health benefits would result from a reduction in exposure 
of  European  citizens  to  harmful  chemicals,  as  chemical  manufacturers  would  voluntarily 
substitute some harmful substances. The reduced exposure would save a fraction of the annual 
costs to public health systems. More benefits will arise from the knock-on effect that the CLP 
Regulation  revision  will  have  on  REACH  and  other  downstream  chemicals  legislation  (for 
example toys, cosmetics, plant protection products or biocides). The measures outlined above 
will also lead to improvements in the level of safety while reducing administrative burden. 

As for human health, a reduced exposure of the environment to hazardous substances will also 
generate savings, in particular from depollution costs. 

Appropriate  and  uniform  hazard  classification  and  communication  will  allow  chemical 
suppliers  and  users,  as  well  as  public  authorities,  to  take  appropriate  chemical  risk 
management measures, while preserving integrity on the EU single market and levelling the 
playing field between companies operating in it. 

Improved communication on the hazards of chemicals through better labelling is expected to 
strengthen  consumers’  understanding  of  the  physical,  health  and  environmental  hazards  of 
chemicals – and thus, to allow them to make more informed purchasing choices. Simplified 
labelling rules will also lead to a highly positive cost-benefit ratio for companies.  

28 

29 

Proposal for a Regulation of the European Parliament and of the Council on a Single Market For Digital 
Services (Digital Services Act) and amending Directive 2000/31/EC, COM(2020) 825 final.  
OJ L 304, 22.11.2011, p. 64.  

EN 

12 

  EN 

                                                 
Prioritisation of the harmonised classification and labelling of substances meeting the criteria 
for  the  new  hazard  classes  will  allow  for  increased  protection  of  human  health  and  the 
environment. 

In terms of economic impacts, investment predictability in the single market will be provided 
on which chemicals will undergo regulatory measures and when. This will offset the costs for 
industry  associated  with  the  addition  of  new  hazard  classes  and  voluntary  substitution.  The 
improvement of the classification process, the simplification and clarification of the labelling 
requirements,  as well as stronger convergence of classifications by industry,  will harmonise 
chemical safety assessments throughout the EU. This will lead to efficiency gains. Improving 
certain  legal  provisions  and  closing  identified  legal  gaps  will  lead  to  better  implementation 
and compliance, creating a more level playing field for the actors in the single market. 

Quantitative estimates of cost and benefits 

While it has not been possible to quantify and monetise all impacts, it is estimated that the set 
of measures enhancing the effectiveness of the Regulation enable direct and indirect savings, 
of  €57.5 million  per  year  for  the  next  10  years.  Amongst  the  quantified  savings,  the 
simplification of the labelling rules would generate more than  €39,5 millions of savings per 
year for the chemical industry.  

In  addition,  the  impact  assessment  identified  other  benefits,  of  which  the  magnitude  is 
confounded by a number of problems, including the possibility of estimating the attributable 
fraction  of  disease  incidence,  prevalence  and  mortality  to  certain  chemical  products.  
However, the human health and environmental  benefits  of the preferred option stem from  a 
reduced  exposure  of  humans  and  of  the  environment  to  hazardous  substances.  Savings  to 
public health systems  and depollution schemes could amount to a significant fraction of the 
costs of endocrine related pathologies, estimated to more than €300 million per year.  

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 (€28.47 million 
for the next 10 years) and adjustment costs for voluntary substitution down the supply chain 
for  substances  which  would  be  identified  as  hazardous  according  to  the  new  hazard  classes 
(€46.04 million for the next 10 years). 

The estimated savings offset the estimated direct and indirect administrative costs, leading to 
a final estimated surplus of €19.95 million per year for the next ten years. The positive ratio 
would  however  turn  negative  (-26.09  million  euro  per  year  for  the  next  ten  years)  when 
adjustment  costs  are  factored  in.  However,  the  overall  cost/benefit  ratio  will  be  positive, 
considering the benefits of an increased protection of human health and of the environment. 

• 

Regulatory fitness and simplification 

In  line  with  the  Commission’s  commitment  to  better  regulation,  this  proposal  has  been 
prepared 
transparency  and  continuous  engagement  with 
stakeholders, listening to external feedback and taking account of external scrutiny to ensure 
the proposal strikes the right balance. 

inclusively,  based  on  full 

Consistent  classification  of  substances  by  companies  and  improved  transparency  will  help 
reduce  the  burden  and  save  costs  for  industry,  as  well  create  a  stronger  basis  for  Member 
States’ enforcement authorities. These measures will contribute to a simplified and searchable 
inventory  (savings  estimated  at  slightly  less  than  €9  million)  that  would  mostly  benefit  to 
SMEs. On hazard communication, broader use of fold-out labels (estimated savings of up to 

EN 

13 

  EN 

around €39.5 million for the detergent industry alone) and introducing exemptions to labelling 
requirements for some chemicals (savings amounting to more than €10 million) will also add 
up. The envisaged measures will therefore also contribute positively to the ‘one in, one out’ 
commitment of the Commission.  

The initiative will entail  costs for companies that  place chemicals  on the EU market  – both 
direct  costs for compliance with the new rules, and indirect  costs for voluntary substitution. 
Costs for small and medium-sized enterprises (SMEs) will be higher in relative terms as they 
benefit less from economies of scale and have less capacity to absorb fixed costs. Clarification 
of the rules on responsibilities for economic actors involved in selling chemicals via distance 
sales (e.g. via online sales) to EU consumers will, however, improve application of the CLP 
for all substances and mixtures placed on the market.  

The prioritisation of the new hazard classes (to be introduced via separate Delegated act (cf. 
above)  for  the  harmonised  classification  and  labelling  will  increase  costs  for  certain 
companies  placing  chemicals  on  the  EU  market.  At  the  same  time,  a  coherent,  EU-wide 
framework will prevent national initiatives putting at risk the internal market.  

Finally, measures to ensure uniformity of classification of identical substances manufactured 
by different companies will enable SMEs to take advantage of classifications included in the 
inventory and not spend costs for classifying. 

• 

Fundamental rights 

The  proposal  respects  the  fundamental  rights  and  observes  the  principles  recognised  in 
particular by the Charter of Fundamental Rights of the European Union30. 

Under Article 52(1) of the Charter, any limitation on the exercise of the rights and freedoms 
recognised by this Charter must be provided for by law and respect the essence of those rights 
and freedoms. Subject to the principle of proportionality, limitations may be made only if they 
are  necessary  and  if  they  genuinely  meet  objectives  of  general  interest  recognised  by  the 
Union or the need to protect the rights and freedoms of others. 

This proposal strikes the right balance between the fundamental right of freedom to conduct a 
business  and  the  fundamental  right  of  property  and  other  fundamental  rights  (environment, 
health, remedy). It has no impact on gender equality. 

The limitation to the right of freedom to conduct a business and the right of property is limited 
to what is necessary to preserve the other above-mentioned fundamental rights and objectives 
of general interest in accordance with Article 52(1). 

The  proposal  contributes  to  (i)  the  objective  of  a  high  level  of  environmental  protection  in 
accordance  with  the  principle  of  sustainable  development  as  laid  down  in  Article  37  of  the 
Charter;  (ii)  the  right  to  life  and  the  integrity  of  the  person  and  its  health  as  laid  down  in 
Articles 2, 3 and 35 of the Charter; and (iii) the right to consumer protection as laid down in 
Article 38. 

It also contributes to the right to an effective remedy as laid down in Article 47, in relation to 
the protection of human health. 

30 

OJ C 364, 18.12.2000, p. 1.  

EN 

14 

  EN 

                                                 
4. 

BUDGETARY IMPLICATIONS 

This proposal does not have immediate budgetary implications. One of the retained measures 
needs  to  allocate  5  FTEs  to  the  Agency.  This  will  be  considered  in  the  on-going  wider 
assessment on the reallocation of tasks to the Agency. 

5. 

• 

 OTHER ELEMENTS 

Procedure for adoption 

This proposal also includes amendments to Articles 23, 25 and 29 as well as to Annexes I, II, 
III, VIII for which the Commission is empowered under Article 53(1) of the CLP Regulation, 
to adopt delegated acts in order to adapt them to technical and scientific progress31. 

While  the  Commission  is  empowered  to  adopt  a  delegated  act  for  the  aforementioned 
amendments, other measures that form part of the same set of amendments pertain to Articles 
for  which  the  Commission  is  required  to  make  a  legislative  proposal  via  the  ordinary 
legislative  procedure.  The  amendments  to  labelling  provisions  are  a  good  example  of  this 
aspect. To ensure the coherence of these measures, the Commission has decided to introduce 
all measures in this legislative proposal, i.e. amendments of essential elements together with 
amendments  of  certain  non-essential  elements  of  the  CLP  Regulation.  This  will  ensure  a 
transparent and effective discussion of the policy package and enable the synergies between 
complementary measures to manifest. Moreover, bundling all amendment proposals together 
will  facilitate  legal  clarity  for  all  involved.  However,  this  has  no  bearing  on  Commission 
empowerment  under  Article  53(1)  of  the  CLP  Regulation,  which  should  be  kept  for  future 
amendments.   

On the other hand, the criteria for the new hazard classes ED, PBT, vPvB, PMT and vPvM 
can be introduced via a delegated act separately as they are self-standing. The timely adoption 
of the delegated act introducing new hazard classes will precede the negotiation process (and 
the final adoption of this proposal) and also facilitate the negotiation on introduction of these 
hazard  classes  into  the  UN  Globally  Harmonized  System  (GHS)  of  Classification  and 
Labelling  of  Chemicals.  The  EU  has  submitted  a  proposal  for  new  work  on  unaddressed 
hazard classes in the GHS work programme for 2023-202432. This underlines the EU’s role as 
global  front  runner  in  the  environment  and  health  protection.  It  contributes  to  the  CLP 
Regulation’s  objective  of  protecting  human  health  and  the  environment  from  the  most 
hazardous  substances,  while  also  ensuring  a  well-functioning  single  market  for  chemicals. 
Lastly,  adoption  of  the  ED  hazard  classes  by  delegated  act  also  responds  to  calls  by  the 
Council  and  the  European  Parliament  for  the  Commission  to  take  swift  action  on  adopting 
criteria  for  endocrine  disruptors.  The  European  Parliament  called  on  the  Commission  to 
‘swiftly take all necessary action33 to ensure a high level of protection of human health and 
the environment against EDs’34. In its conclusions of June 2019, the Council also called for 

31 

32 

33 

Article  53(1)  of  Regulation  (EC)  No 1272/2008  empowers  the  Commission  to  amend  Articles  6(5), 
11(3), 12, 14, 18(3)(b), 23, 25 to 29 and 35(2) second and third subparagraph and Annexes I to VIII in 
order to adapt them to technical and scientific progress.   

Proposal  for  new  work  on  unaddressed  hazard  classes  in  the  programme  of  work  for  the  biennium 
2023-2024 (European Union) |UNECE 

European Parliament resolution of 18 April 2019 on a comprehensive European Union framework on 
endocrine disruptors (2019/2683(RSP)) (P8_TA(2019)0441). 

EN 

15 

  EN 

                                                 
urgent  action35.  Moreover,  the  Council  Conclusions  of  15  March  202136,  which  expressed 
explicit support for introducing the new hazard criteria, called for full implementation of the 
Chemicals Strategy for Sustainability ‘without undue delay’. 

• 

Implementation plans and monitoring, evaluation and reporting arrangements 

To  monitor  and  evaluate  the  effectiveness  of  this  proposal,  the  Commission  is  currently 
developing a framework – due by 2024 – of indicators monitoring the drivers and impacts of 
chemical pollution and measuring the effectiveness of chemicals legislation. The development 
involves  the  expertise  of  all  relevant  agencies,  in  particular  the  European  Environment 
Agency  and  the  European  Chemicals  Agency.  This  framework  will  be  fully  aligned  to  and 
complement the monitoring and outlook framework of the EU zero pollution action plan and 
the monitoring framework of the 8th environment action programme to 2030.  

• 

Detailed explanation of the specific provisions of the proposal 

The amendment of Article 1(1) results into a clarification that the obligations under Article 45 
to  notify  poison  centres  also  cover  certain  distributors,  i.e.  relabellers,  rebranders  and 
distributors  supplying  in  another  Member  State  than  the  one  in  which  the  mixture  was 
notified.  

The  amendment  to  Article  2  introduces  a  definition  for  multi-constituent  substances  and  of 
acute toxicity estimates. 

The  amendment  of  Article  4(10)  requires  that  there  is  a  supplier  established  in  the  Union, 
which  ensures  that  the  substance  or  the  mixture  meets  the  requirements  set  out  in  the  CLP 
Regulation when it is being placed on the market, including via distance sales. This provision 
will improve compliance with and enforcement of the CLP Regulation and will ensure a high 
level of protection of human health and the environment. In order to prevent situations where 
consumer becomes de jure and de facto an importer when buying the substance or the mixture 
via distance sales from the economic operators established outside the EU, the amendment of 
Article  4(10)  specifies  that  the  supplier  in  the  EU  which  ensures  that  the  substance  or  the 
mixture in question meets the requirements set out in the CLP Regulation acts in course of an 
industrial or professional activity.    

The new Article 5(3) sets out that ‘multi-constituent substances’ shall, normally, be classified 
following the same classification, labelling, and packaging rules as mixtures and includes the 
these  ‘multi-constituent 
identification  and  examination  of  available 
substances’. 

information  on 

Article  6(3)  and  Article  6(4)  are  amended  to  extend  to  the  new  hazard  classes  regarding 
endocrine  disruptors,  PBT,  vPvB,  PMT  and  vPvM  the  classification  provisions  already  in 
place for certain hazard classes, according to which the information on the substance included 
in the mixture is used to classify the mixture itself. 

34 

35 

36 

‘Towards  a  Sustainable  Chemicals  Policy  Strategy  of  the  Union-Council  conclusions’,  26  June  2019, 
https://data.consilium.europa.eu/doc/document/ST-10713-2019-INIT/en/pdf  

//data.consilium.europa.eu/doc/document/ST-10713-2019-INIT/en/pdf, p.3 

‘Sustainable Chemicals Strategy of the Union: Time to Deliver-Council conclusions’, 15 March 2021, 
https://www.consilium.europa.eu/media/48827/st06941-en21.pdf 

EN 

16 

  EN 

                                                                                                                                                         
 
Amendments to Article 9(3) and (4) clarify the use of bridging principles in order to classify a 
mixture  or  ‘multi-constituent  substance’,  simultaneously  when  applying  the  weight  of 
evidence approach using expert judgement. 

Amendments  to  Article  10  require  manufacturers,  importers  and  downstream  users  to 
establish acute toxicity estimates that allow for the calculation of thresholds at or above which 
a  substance  or  mixture  is  to  be  classified  as  acutely  toxic.  Where  specific  acute  toxicity 
estimates exist for those hazard classes for which substances have a harmonised classification 
and labelling (entries in Table 3 of Part 3 of Annex VI to the CLP Regulation), acute toxicity 
estimates  must  not  be  set  by  manufacturers,  importers  or  downstream  users.  Furthermore, 
application  rules  for  concentration  limits  are  clarified  for  cases  in  which  the  presence  of  a 
hazardous substance as an identified impurity, additive or individual constituent leads to the 
classification of a mixture.  

Amendments  to  Article  23  and  Section  1.3.  of  Annex  I  provide  derogations  from  some 
labelling obligations for certain ammunition that are not articles and set out specific rules for 
the labelling of certain ammunition shot through firearms. 

Furthermore,  the  obligation  under  Article  32(6)  to  include  label  elements  that  are  resulting 
from  requirements  provided  for  in  other  EU  acts  is  moved  to  Article  25.  The  obligation  to 
include supplemental information on certain mixtures that containing classified substances in 
Article 25(6) is extended to also cover also certain mixtures which that contain non-classified 
substances that share the properties set out in Part 2 of Annex II to the CLP Regulation.  

The amendments to Article 29 and Section 1.5 of Annex I set out specific labelling provisions 
for  substances  and  mixtures  in  very  small  containers;  where  the  container  is  so  small  that 
these  obligations  cannot  be  met,  a  reduction  in  the  label  elements  is  allowed  according  to 
specific  rules.  It  also  sets  out  specific  provisions  for  labelling  of  chemicals  sold  in  bulk  to 
consumers. Furthermore, ammunition used by the military in combat zones is exempted from 
labelling requirements under certain conditions. 

The amendment to Article 30 clarifies the timeframe for the obligation to update the label by 
setting a fixed deadline and by clearly defining the start of the transition periods.  

The  amendments  to  Article  31(1)  and  (3)  introduce  obligatory  formatting  rules  for  labels, 
especially for fold-out labels. 

Article 32(6) is deleted as the obligation to place label elements resulting from requirements 
provided for in  other EU acts  in  the section for supplemental  label  information  is  moved to 
Article 25. 

The newly introduced Articles 34a and 34b set out the rules  on digital labelling. Only label 
elements that are not instrumental in protection of health and safety and the environment, and 
are not obligatory under GHS may be replaced by a digital label. The digital label must meet 
certain requirements. For example, it must be searchable, available in less than two clicks and 
not  track  any  user  data.  The  Commission  should  be  empowered  to  adopt  delegated  acts  in 
accordance with Article 53(1) in order to  adapt the labelling elements that may be provided 
digitally only to technical and scientific progress as well as to digital readiness. 

The amendment to Article 36 adds the new hazard classes to be adopted via the delegated act 
(ED, PBT, vPvB, PMT, vPvM) to the list of hazards that are normally subject to harmonised 
classification and labelling. 

The  amendment  of  Article  37  mandates  the  Commission  to  initiate  the  harmonised 
classification and labelling procedure in addition to the right currently conferred on Member 
States  competent  authorities  and  manufacturers,  importers  and  downstream  users.  In  such  a 

EN 

17 

  EN 

case,  the  dossiers  would  be  developed  either  by  the  Agency  or  by  the  Authority.  The 
possibility to initiate harmonised classification and labelling proposals for several substances 
at once is added by replacing the references to ‘substance’ by ‘substances’. It is clarified that 
the  harmonised  classification  and  labelling  procedure  under  Article  37  can  include  acute 
toxicity estimates where appropriate. Paragraphs 7 and 8 are added to Article 37 to insert an 
obligation on the Commission to adopt delegated acts to amend Annex VI in order to include 
in Table 3 of Part 3 of that Annex substances that have been included in the candidate list as 
ED,  PBT  or  vPvB  under  the  REACH  Regulation,  and  those  that  have  not  been  approved 
under the Plant Protection Products Regulation and the Biocidal Products Regulation or those 
that have been approved because they fulfilled the conditions for derogation. 

Article 38 is amended to adjust to the newly defined acute toxicity estimates. 

The amendment to Article 40(1) introduces and specifies the obligation to provide the Agency 
with the reasons for divergence from other classification entries for the same substance and to 
update notifications within 6 months after a decision to change the classification and labelling 
of a substance has been taken.  

The  amendment  to  Article  42(1)  sets  out  that  the  identity  of  the  notifier  must  be  made 
publicly  available,  subject  to  duly  motivated  confidentiality  requests.  If  there  are  group 
notifications, only the identity of the notifier acting on behalf of the group members needs to 
be made publicly available.  

The amendment to Article 45 obliges certain distributors to notify information on emergency 
health  responses  to  appointed  bodies  where  the  latter  would  not  have  all  the  information 
required  to  carry  out  the  tasks  for  which  they  are  responsible,  in  particular  in  case  of 
distribution across borders, or re-branding or re-labelling. This information could now also be 
shared with the Commission and with the Agency upon request for the purpose of statistical 
analysis and evaluating the need for risk management measures.    

The amendment to Article 48 makes a distinction between advertisements and distance sales 
offers  linked  to  the  marketing  and  sale  of  hazardous  chemicals.  It  provides  that 
advertisements of hazardous substances and certain mixtures should contain, in addition to the 
hazard  class,  the  hazard  pictogram,  the  signal  word  and  the  hazard  statements.  The  newly 
introduced  Article  48a  provides  for  requirement  for  distance  sales  offers  to  indicate  the 
applicable labelling information. 

Amending Article 50 provides for the possibility of designating the Agency as the appointed 
body  to  receive  relevant  information  for  emergency  health  responses  under  Article  45.  It 
further  tasks  the  Agency  with  ensuring  the  availability  of  appropriate  tools  to  share 
information  with  national  appointed  authorities  so  they  fulfil  their  other  obligations  under 
Article  45.  Furthermore,  it  clarifies  the  Agency’s  remit  of  providing  competent  authorities 
with tools to support CLP Regulation implementation and industry with tools to comply with 
the CLP Regulation.  

Article 53 paragraph 1 is amended to empower the Commission to amend the new Article 34a 
on  the  content  of  digital  labels  by  means  of  delegated  acts.  This  is  based  on  technical  and 
scientific progress and the level of digital readiness among all population groups.It is further 
amended to oblige the Member States and the Commission to promote harmonisation of the 
criteria for classifying and labelling ED, PMT and vPvM substances at UN level, in the same 
way  as  their  current  obligation  related  to  the  criteria  for  classifying  and  labelling  PBT  and 
vPvB substances. The same obligation is introduced on the promotion of non-animal methods 
at the UN. 

EN 

18 

  EN 

The amendment to Article 53c relates to the scope of the Commission’s obligation to adopt 
separate delegated acts in respect of each power delegated to it under the CLP Regulation. It 
aims to allow for the adoption of one single delegated act when it amends Part 1 and Part 2 
together  with  Part 3  of  Annex  VI  to  the  CLP  Regulation  triggered  by  the  harmonised 
classification procedure of a particular substance or group of substances.   

Part 1 of Annex I is amended to provide that supplemental labelling information under Article 
25(3) may be provided in a digital format only. It will introduce formatting requirements for 
labels,  specific labelling requirements for bulk  sales as well as an exemption  from  labelling 
requirements for certain mixtures in small packaging and for certain ammunitions. Moreover, 
it clarifies a provision on the weight of evidence determination. The amendment to Part 5 of 
Annex II specifies a labelling exemption for ready-mixed cement and concrete in the wet state 
and  sets  out  an  exemption  from  the  labelling  obligations  for  sales  of  chemicals  in  bulk  to 
consumers.  It  also  sets  specific  packaging  requirements  for  bulk  products  for  sale  at  refill 
stations. 

Amendments to Part A and Part B of Annex VIII extend the obligation to submit information 
to  certain  other  suppliers,  in  addition  to  downstream  users  and  importers,  where  appointed 
bodies  would  not  have  sufficient  information  to  provide  an  adequate  emergency  health 
response.  The  amendments  also  define  the  term  ‘composition  conforming  with  a  standard 
formula’ in the context of certain submission requirements for gypsum, ready-mixed concrete 
and cement. They introduce the obligation to provide the name and product description of the 
standard formula for the fuel in the submission and provide in certain cases for the obligation 
to submit information on components even if they are not always present. Furthermore, they 
clarify  when  submission  updates  are  required,  as  well  as  ways  to  identify  the  mixture, 
submitter and contact point by means of their product identifier.  

EN 

19 

  EN 

  
2022/0432 (COD) 

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 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114(1) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee1, 
Acting in accordance with the ordinary legislative procedure2, 

Whereas: 

(1) 

In order to keep pace with globalisation, technological development and new means of 
sale, such as  online sales, it is  necessary to adapt  Regulation  (EC)  No  1272/2008  of 
the European Parliament and of the Council. While under that Regulation it is assumed 
that  all  responsible  actors  in  the  supply  chain  are  established  in  the  Union,  practical 
experience  has  shown  that  economic  operators  established  outside  the  Union  sell 
chemicals  online  directly  to  the  general  public  in  the  Union.  Hence,  enforcement 
authorities  are  unable  to  enforce  Regulation  (EC)  No  1272/2008  against  economic 
operators not established in the Union. It is therefore appropriate to require that there 
is a supplier established in the Union, which ensures that the substance or the mixture 
in question meets the requirements set out in that Regulation when it is being placed 
on the market, including via distance sales. This provision would improve compliance 
with  and  enforcement  of  the  Regulation  (EC)  No  12727/2008  and  thereby  ensure  a 
high  level  of  protection  of  human  health  and  the  environment.  In  order  to  prevent 
situations where consumer becomes de jure and de facto an importer when buying the 
substance  or  the  mixture  via  distance  sales  from  the  economic  operators  established 
outside  the  Union,  it  is  necessary  to  specify  that  the  supplier  which  ensures  that  the 
substance or the mixture in question meets the requirements set out in that Regulation 
acts in course of an industrial or professional activity.   

(2) 

From a toxicological point of view, substances with more than one constituent (‘multi-
constituent  substances’)  are  no  different  from  mixtures  composed  of  two  or  more 
substances.  In  accordance  with  Article  13  of  Regulation  (EC)  No  1907/2006  of  the 

1 
2 

OJ C , , p. . 
Position of the European Parliament of xxx and decision of the Council of xxx. 

EN 

20 

  EN 

                                                 
European Parliament and of the Council3, aimed to limit animal testing, data on multi-
constituent  substances  is  to  be  generated  under  the  same  conditions  as  data  on  any 
other substance, while data on individual constituents of a substance is normally not to 
be  generated,  except  where  individual  constituents  are  also  substances  registered  on 
their  own.  Where  data  on  individual  constituents  is  available,  multi-constituent 
substances  should be  evaluated and classified  following the same classification rules 
as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific 
provision for those multi-constituent substances. 

It is normally not possible to sufficiently assess the endocrine disrupting properties for 
human  health  and  the  environment  and  the  persistent,  bioaccumulative  and  mobile 
properties of a mixture or of a multi-constituent substance on the basis of data on that 
mixture or substance. The data for the individual substances of the mixture or for the 
individual constituents of the multi-constituent substance should therefore normally be 
used  as  the  basis  for  hazard  identification  of  those  multi-constituent  substances  or 
mixtures.  However,  in  certain  cases,  data  on  those  multi-constituent  substances 
themselves  may  also  be  relevant.  This  is  the  case  in  particular  where  that  data 
demonstrates  endocrine  disrupting  properties  for  human  health  and  the  environment, 
as well as persistent, bioaccumulative and mobile properties, or where it supports data 
on  the  individual  constituents.  Therefore,  it  is  appropriate  that  data  on  multi-
constituent substances are used in those cases. 

In order to improve legal certainty and implementation with regard to the evaluation of 
hazard information for mixtures where no or inadequate test data are available for the 
mixture itself, the interaction between the application of the bridging principles and a 
weight  of  evidence  determination  using  expert  judgement  should  be  clarified.  Such 
clarification should ensure that the weight of evidence determination complements but 
does not substitute the application of the bridging principles. It should also be clarified 
that  if  bridging  principles  cannot  be  applied  to  evaluate  a  mixture,  manufacturers, 
importers and downstream users should  use the calculation method or other methods 
described in Parts 3 and 4 of Annex I to Regulation (EC) No 1272/2008. It should also 
be  clarified  which  criteria,  when  not  met,  determine  when  a  weight  of  evidence 
determination using expert judgment is to be carried out.  

To  avoid  over-classification  of  mixtures  which  contain  substances  classified  as 
hazardous  solely  due  to  the  presence  of  an  impurity,  an  additive  or  an  individual 
constituent,  and  of  mixtures  which  contain  other  mixtures  with  such  substances,  the 
classification  should  only  be  mandatory  if  such  impurity,  additive  or  individual 
constituent  is  contained  in  the  mixture  or  in  the  final  mixture  at  or  above  a  certain 
concentration limit as referred to in Annex I to Regulation (EC) No 1272/2008. 

Acute  toxicity  estimates  are  mainly  used  to  determine  the  classification  for  human 
health  acute  toxicity  of  mixtures  containing  substances  classified  for  acute  toxicity. 
Substances can be  classified in one of four acute toxicity hazard categories based on 
the  oral,  dermal  or  inhalation  exposure  route  according  to  certain  numeric  criteria. 
Acute  toxicity  values  are  expressed  as  (approximate)  LD50  (oral,  dermal)  or  LC50 

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1). 

(3) 

(4) 

(5) 

(6) 

3 

EN 

21 

  EN 

                                                 
(inhalation)  values  or  as  acute  toxicity  estimates.  It  is  appropriate  to  specify  the 
meaning  of,  and further  specify,  acute toxicity  estimates to  increase  their  clarity  and 
consistency. As acute toxicity estimates are part of the harmonised classification and 
labelling elements of substances classified for acute toxicity they should be included in 
the  proposal,  opinion  and  decision  for  harmonised  classification  of  a  substance  for 
acute  toxicity.  In  the  same  way  as  M-factors  and  concentration  limits,  acute  toxicity 
estimates  should,  together  with  a  justification,  be  notified  to  the  Agency  in  view  of 
their inclusion in the classification and labelling inventory.  

Ammunition  qualifying  as  a  substance  or  a  mixture  is  to  bear  a  label  affixed  to  the 
surface  of  the  packaging  immediately  containing  the  substance  or  the  mixture  (inner 
packaging),  which  is  typically  the  ammunitions’  cartridge.  Affixing  a  label  to  the 
cartridge might however cause safety problems for the user, as the label could interfere 
with  the  correct  functioning  of  the  ammunition  and  could  damage  the  firearm.  Such 
ammunition should therefore be allowed to bear a label affixed to the next packaging 
layer  instead  of  the  inner  packaging.  In  addition,  labelled  ammunition,  which  is 
exclusively used by national defence forces in combat zones, could, in specific cases, 
constitute  an  unacceptable  safety  or  security  risk  for  the  cargo,  soldiers  and  staff,  if 
sufficient camouflaging cannot be ensured. For such cases, it is necessary to provide 
for  an  exemption  from  the  labelling  requirements  and  allow  for  alternative  ways  of 
communicating the hazard information.   

In order to enhance clarity, all supplemental labelling requirements  should be placed 
together in one Article. 

Part  2  of  Annex  II  to  Regulation  (EC)  No  1272/2008  sets  out  rules  for  additional 
hazard statements to be included on the label of certain mixtures listed in Part 2 of that 
Annex.  Given  that  those  statements  provide  important  additional  information  in 
specific cases, they should be applied to all mixtures referred to in Part 2 of Annex II, 
regardless  of  whether  they  are  classified  and  whether  they  contain  any  classified 
substance. 

(7) 

(8) 

(9) 

(10)  To increase enforceability of the obligation placed on suppliers to update their labels 
after  a  change  in  the  classification  and  labelling  of  their  substance  or  mixture,  a 
deadline should be laid down as regards that obligation. A similar obligation placed on 
registrants  is  set  out  in  Commission  Implementing  Regulation  (EU)  2020/14354. 
Where  the  new  hazard  class  is  additional  to  an  existing  hazard  class  or  represents  a 
more severe hazard class or category, or where new supplemental labelling elements 
are required under Article 25, the deadline to  update the labelling information  in  the 
case  of  adaptation  of  the  classification  in  accordance  with  the  result  of  a  new 
evaluation  should  be  set  at  6  months  from  the  day  on  which  the  results  of  a  new 
evaluation on the classification of that substance or that mixture were obtained. In case 
where  a  classification  is  updated  to  a  less  severe  hazard  class  or  category  without 
triggering  classification  in  an  additional  hazard  class  or  new  supplemental  labelling 
requirements, the deadline for updating the labels should remain at 18 months from the 
day on which the results of a new evaluation on the classification of that substance or 
that  mixture  were  obtained.  It  should  also  be  clarified  that,  in  cases  of  harmonised 

4 

Commission  Implementing  Regulation  (EU)  2020/1435  of  9  October  2020  on  the  duties  placed  on 
registrants  to  update  their  registrations  under  Regulation  (EC)  No  1907/2006  of  the  European 
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH) (OJ L 331, 12.10.2020, p.24.) 

EN 

22 

  EN 

                                                 
classification and labelling, the deadlines to update the labelling information should be 
set  at  the  date  of  application  of  the  provisions  setting  out  the  new  or  amended 
classification  and  labelling  of  the  substance  concerned,  which  is  usually  18  months 
from  the  date  of  entry  into  force  of  those  provisions.  The  same  applies  in  case  of 
changes  triggered  by  other  delegated  acts  adopted  in  light  of  the  adaptation  to 
technical and scientific progress, for instance as a result of the implementation of new 
or amended provisions of the UN Globally Harmonized System of Classification and 
Labelling of Chemicals (GHS). 

(11)  Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general 
rules  for  the  application  of  labels  cannot  be  met  due  to  the  shape  or  form  of  the 
packaging  or  its  small  size,  whilst  it  does  not  provide  for  a  minimum  font  size  of 
labels  that  would  ensure  readability.  As  a  result  of  advancements  in  labelling 
technologies, more flexibility should be given to suppliers by providing for a broader 
use  of  fold-out  labels,  while  readability  of  labels  should  be  ensured  by  laying  down 
minimum font size and formatting requirements. 

(12)  Regulation  (EC)  No  1272/2008  needs  to  be  adjusted  to  technological  and  societal 
changes in the field of digitalisation and be prepared for future developments. Digital 
labelling  could  improve  the  efficiency  of  hazard  communication,  especially  for 
vulnerable population groups and people who do not speak the national language of a 
Member State. Therefore, it is necessary to provide for voluntary digital labelling and 
to  lay  down  technical  requirements  for  such  labelling.  In  order  to  provide  for  legal 
certainty, it is appropriate to specify the label elements that are allowed to be provided 
in a digital format only. That possibility should only exist for information which is not 
instrumental for the safety of the user or the protection of the environment.     

(13) 

(14) 

In order to adapt the label elements allowed to be provided only in a digital format to 
technical progress or to  the level of digital readiness among all population groups in 
the  Union,  the  Commission  should  be  empowered  to  adopt  delegated  acts  in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
to  amend  the  list  of  label  elements  allowed  to  be  provided  only  in  a  digital  format, 
taking into account societal needs and a high level of protection of human health and 
the environment.  

In  order  to  adjust  to  technological  changes  and  developments  in  the  field  of 
digitalisation,  the  Commission  should  be  empowered  to  adopt  delegated  acts  in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
to  supplement  Regulation  (EC)  No  1272/2008  by  further  specifying  the  technical 
requirements for the digital labelling. 

(15)  Regulation  (EC)  No  1272/2008  currently  does  not  lay  down  any  specific  rules  for 
labelling and packaging  of substances or mixtures supplied to the general public and 
professional  users  via  refill  stations.  Considering  the  increasing  trend  of  selling 
products, including certain chemicals such as detergents, without packaging to reduce 
waste and to facilitate more sustainable sales forms, it is appropriate to set out specific 
rules and conditions  for such type of sales, and establish a list of hazard classes  and 
categories prohibiting such refill station sales for substances of mixtures  meeting the 
criteria  for  classification  in  those  hazard  classes  and  categories,  in  order  to  ensure 
safety and the protection of human health.  

(16)  Regulation (EC) No 1272/2008 does not lay down rules on the labelling of chemicals 
supplied to the general public without packaging except for ready mixed cement and 
concrete in a wet state. In order to enhance legal clarity and ensure a better protection 

EN 

23 

  EN 

of citizens,  it is  appropriate to  provide for the labelling elements  of other chemicals, 
such  as  fuels  supplied  at  filling  stations  and  intended  to  be  pumped  into  receptacles 
from where they are normally not intended to be removed.   

includes 

respiratory 

(17)  As  the  new  hazard  classes  and  criteria  introduced  by  Commission  Delegated 
Regulation5 allow for the harmonised classification and labelling of substances of the 
highest  concern  with  regard  to  health  and  environment,  they  should  normally  be 
subject  to  harmonised  classification  and  labelling  and  added  to  the  list  of  hazard 
classes  which 
sensitisation,  germ  cell  mutagenicity, 
carcinogenicity  and  reproductive  toxicity.  Sub-categorisation  of  the  hazard  class  for 
respiratory  sensitisation  in  sub-category  1A  or  1B  should  be  performed  where 
sufficient information to classify in those hazard sub-categories is available, in order 
to  avoid  over- or under-classification.  In view of the rapid  development  of scientific 
knowledge  and  the  long-standing  expertise  of  the  European  Chemicals  Agency  (the 
‘Agency’) and the European Food Safety Authority (the ‘Authority’) on the one hand, 
and  the  limited  resources  of  Member  States’  competent  authorities  to  develop 
harmonised  classification  proposals  on  the  other,  the  Commission  should  have  the 
right to request the Agency  and the Authority to develop a harmonised classification 
and labelling proposal.  

(18)  Harmonised  classification  and  labelling  proposals  need  not  necessarily  be  limited  to 
individual  substances  and  could  cover  a  group  of  similar  substances,  where  such 
similarity allows for similar classification of all substances in the group. The purpose 
of such grouping is to alleviate the burden on manufacturers, importers or downstream 
users,  the  Agency  and  the  Commission  in  the  procedure  for  harmonisation  of 
classification  and  labelling  of  substances.  It  also  avoids  testing  of  substances  when 
similar substances can be classified as a group. 

(19)  To increase transparency and predictability of the proposals submitted to the Agency, 
the  Member  States’  competent  authorities,  manufacturers,  importers  or  downstream 
users should be required to notify  the Agency of their intention to submit a proposal 
for harmonised classification and labelling, while the Commission should be required 
to notify the Agency of its request to the Agency or to the Authority to prepare such 
proposal. Furthermore, the Agency should be required to publish information on such 
intention  or  request  and  update  the  information  regarding  the  submitted  proposal  at 
each  stage  of  the  procedure  for  the  harmonised  classification  and  labelling  of 
substances.  For  the  same  reason,  a  competent  authority  that  receives  a  proposal  for 
revision  of  a  harmonised  classification  and  labelling  submitted  by  a  manufacturer, 
importer or downstream user should be required to communicate its decision to accept 
or refuse the proposal for revision to the Agency, which should share that information 
with the other competent authorities. receives a proposal for revision of a harmonised 
classification and labelling submitted by a manufacturer, importer or downstream user 
should  be  required  to  communicate  its  decision  to  accept  or  refuse  the  proposal  for 
revision to the Agency, which should share that information with the other competent 
authorities.  

(20)  The criteria for inclusion of substances in the candidate list referred to in Article 59(1) 
of Regulation (EC) No 1907/2006 are equivalent to those of certain hazard classes and 

5 

[Commission Delegated Regulation amending Regulation (EC) No 1272/2008 as regards hazard classes 
and criteria for the classification, labelling and packaging of substances and mixtures, OJ XX of XX p 
XX.] 

EN 

24 

  EN 

                                                 
categories included in Annex I to Regulation (EC) No 1272/2008. In view of the high 
level of evidence required for inclusion in the candidate list, the substances currently 
on that list should be included in Table 3 in Part 3 of Annex VI to Regulation (EC) No 
1272/2008.  

(21)  As the criteria for substances to qualify as endocrine disruptor for human health or the 
environment included in sections 3.6.5. and 3.8.2. of Annex II to Regulation (EC) No 
1107/2009  and  in  Commission  Delegated  Regulation  (EU)  2017/2100,  and  those  to 
qualify as endocrine disruptor for human health or the environment included in Annex 
I  to  Regulation  (EC)  No  1272/2008,  are  equivalent,  substances  which  qualify  as 
meeting the criteria for endocrine disruptor properties in accordance with Commission 
Regulation  (EU)  2018/605  and  Commission  Delegated  Regulation  (EU)  2017/2100 
should be included as endocrine disruptors category 1 for human health or endocrine 
disruptors  category  1  for  the  environment  in  Table  3  in  Part  3  of  Annex  VI  to 
Regulation (EC) No 1272/2008.   

(22)  As  Article  5(1),  point  (e),  of  Regulation  (EU)  No  528/20126  refers  to  the  PBT  and 
vPvB criteria included in Annex XIII to Regulation (EC) No 1907/2006 to identify the 
PBT and vPvB properties of active substances and as those criteria are equivalent to 
those  included  in  Annex  I  to  Regulation  (EC)  No  1272/2008,  the  active  substances 
meeting the criteria to qualify as PBT and vPvB under Regulation (EU) No 528/2012 
and under Annex XIII to Regulation (EC) No 1907/2006 should be included in Table 3 
of Part 3 of Annex VI to Regulation (EC) No 1272/2008. As PBT and vPvB properties 
included in sections 3.7.2. and 3.7.3. of Annex II to Regulation (EC) No 1107/2009 of 
the European Parliament and of the Council7 are equivalent to those included in Annex 
I  to  Regulation  (EC)  No  1272/2008,  the  active  substances  meeting  the  criteria  to 
qualify  as  PBT  and  vPvB  according  to  those  criteria  in  sections  3.7.2.  and  3.7.3.  of 
Annex II to Regulation (EC) No 1107/2009 should be included in Table 3 in Part 3 of 
Annex VI to Regulation (EC) No 1272/2008.  

(23)  As the substances referred to in recitals 30 and 31 have already been assessed by the 
European Food Safety Authority or the Agency as well as the Commission which has 
decided upon by them, they should be included in  Table 3 of Part 3 of Annex VI to 
Regulation  (EC)  No  1272/2008  by  a  delegated  act,  without  prior  consultation  of  the 
Agency as provided for in Article 37(4) of Regulation (EC) No 1272/2008.  

(24)  Manufacturers and importers often notify different information for the same substance 
to  be  included  in  the  Agency’s  inventory  for  classification  and  labelling.  In  some 
cases,  such  divergences  result  from  different  impurities,  physical  states  or  other 
differentiations  and  may  be  justified.  In  other  cases,  the  divergences  are  due  to 
differences  in  data  used  for  classification,  or  to  disagreement  between  notifiers  or 
registrants in the case of joint submission of data in accordance with Regulation (EC) 
No 1907/2006, or to obsolete classification entries. As a result, the classification and 
labelling inventory contains divergent classifications, which makes the inventory less 
effective  as  a  hazard  collection  and  communication  tool  and  leads  to  incorrect 

6 

7 

Regulation  (EC)  No  528/2012  of  22  May  2012 of  the  European  Parliament  and  of  the  Council 
concerning  the  making  available  on  the  market  and  use  of  biocidal  products  (OJ  L  167  of  27.6.2012 
p.1). 

Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  of  21  October  2009 
concerning  the  placing  of  plant  protection  products  on  the  market  and  repealing  Council  Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 

EN 

25 

  EN 

                                                 
 
(25) 

classifications,  ultimately  hindering  the  ability  of  Regulation  (EC)  No  1272/2008  to 
protect human health and the environment. Therefore, the notifiers should be required 
to  provide  reasons  for  divergence  from  the  most  severe  classification  or  for 
introducing a more severe classification per hazard class for the same substance to the 
Agency.  To  address  divergences  between  more  recent  and  obsolete  classifications, 
notifiers  should  be  required  to  update  their  notifications  within  6  months  after  a 
decision  to  change  the  classification  and  labelling  of  a  substance  has  been  taken 
pursuant to a review in Article 15(1) of that Regulation. 

In order to enhance transparency of notifications as well as to facilitate the notifiers’ 
duty  to  come  to  an  agreed  notification  entry  for  the  same  substance,  certain 
information  notified to  the Agency’s classification and labelling inventory should be 
made  publicly  available,  free  of  charge.  Without  prejudice  to  the  protection  of 
commercial  interests,  that  information  should  include  the  identity  of  the  notifiers  as, 
knowing whom to contact, would facilitate the objective of coming to an agreed entry 
to be included in that classification and labelling inventory. In the case of notifications 
by a group of manufacturers or importers, it should suffice to make publicly available 
the identity of the notifier submitting the information on behalf of the other members 
of the group.  

(26)  Pursuant  to  Article 45(1) of Regulation  (EC) No 1272/2008,  appointed bodies in  the 
Member  States  are  to  receive  relevant  information  relating  to  emergency  health 
response  submitted  by  importers  and  downstream  users  placing  on  the  market 
mixtures that are hazardous based on their health or physical effects.  Distributors are 
not required to submit such information. In certain cases of distribution across borders 
from one Member State to another, or where distributors rebrand or relabel mixtures, 
the  absence  of  such  submission  obligation  causes  information  loss  for  the  appointed 
bodies which may prevent them from providing adequate emergency health response. 
To  address  this  situation,  an  obligation  to  submit  information  relating  to  emergency 
health response should also be introduced for distributors, where they further distribute 
hazardous mixtures in other Member States or where they rebrand or relabel hazardous 
mixtures. 

(27)  Pursuant  to  Article 45(3) of Regulation  (EC) No 1272/2008,  appointed bodies are to 
have  all  the  required  information  available  to  provide  adequate  emergency  health 
response.  The  Agency  already  set  up  and  maintains  a  Union  level  Poison  Centres 
Notification  portal,  and  established,  developed  and  maintains  a  database  containing 
information  relating  to  emergency  health  response  to  assist  some  Member  States  in 
complying with that Regulation. Therefore, the Agency would be in a position to fulfil 
the  task  of  receiving  that  information.  To  reduce  administrative  burden  for  Member 
States  and  take  advantage  of  economies  of  scale,  Regulation  (EC)  No  1272/2008 
should  provide  for  the  option  of  appointing  the  Agency  as  a  body  responsible  for 
receiving the relevant information, should a Member State wish to do so.  

(28) 

In  addition  to  the  Member  States’  appointed  bodies,  the  Commission  or  the  Agency 
should be able to  use the information  relating  to  emergency health responses  for the 
purpose  of  carrying  out  statistical  analysis.  That  would  usefully  complement 
information  on  the  uses  of  substances  submitted  as  part  of  registration  under 
Regulation (EC) No 1907/2006, while enabling a better prioritisation of substances to 
be  subject  to  harmonised  classification  and  labelling  under  Regulation  (EC)  No 
1272/2008 and feeding into the risk management processes under Regulation (EC) No 
1907/2006, and potentially under other Union acts.  

EN 

26 

  EN 

(29)  Regulation  (EC) No 1272/2008  regulates advertisement  of hazardous substances  and 
mixtures  in  a  general  manner  and  provides  that  an  advertisement  for  a  substance 
classified  as  hazardous  is  to  mention  the  hazard  classes  or  hazard  categories 
concerned,  and  an  advertisement  for  a  mixture  classified  as  hazardous  or  a  mixture 
containing  a  classified  substance  is  to  mention  the  types  of  hazards  indicated  on  the 
label where such advertisement allows concluding a contract for purchase without first 
having  sight  of  the  label.  This  obligation  should  be  changed  to  ensure  that  the 
advertisement  of  hazardous  substances  and  mixtures  contains  all  the  information 
which  is  most  important  in  terms  of  safety  and  protection  of  the  environment. 
Therefore, the advertisement should contain the hazard pictogram, the signal word, the 
hazard class and the hazard statements. The hazard category should not be provided, 
as it is reflected by the hazard statement. 

(30)  Regulation (EC) No 1272/2008 does not explicitly refer to offers, let alone to distance 
sales offers. Consequently, it does not address specific problems arising from distance 
sales, such as online sales. Whereas advertisements is understood as being at the pre-
stage of offers, notably  as information  designed  to  promote messages  of a natural  or 
legal person, whether or not against remuneration, offers are understood as invitations 
by  a  natural  or  legal  person  to  conclude  a  purchase  contract.  This  differentiation 
should justify the requirement of providing more hazard information in offers than in 
advertisements. In order to keep pace with technological development and new means 
of  sale,  the  compliance  by  design  obligations  laid  down  for  providers  of  online 
marketplaces in Article 31 of Regulation (EU) 2022/2065 of the European Parliament 
and of the Council8 should apply for the purpose of labelling information required by 
Article 17 of Regulation (EC) No 1272/2008. The enforcement of those obligations is 
subject to the rules laid down in Chapter IV of Regulation (EU) 2022/2065.  

(31)  Apart  from  providing  industry  with  technical  and  scientific  tools  on  how  to  comply 
with  Regulation  (EC)  No  1272/2008,  the  Agency  should  also  provide  competent 
authorities with such tools, for example databases, in order to foster implementation. 
Regulation (EC) No 12727/2008 should  more in  detail set out the Agency’s remit in 
this regard. Furthermore, the Agency, acting as a body appointed by a Member State 
competent authority for receiving information for emergency health response, should 
provide  the  relevant  national  appointed  body  of  that  Member  State  access  to  that 
information. 

(32)  After  consultation  of  the  Commission  expert  group  of  Competent  Authorities  for 
REACH9  and  CLP10,  the  Commission  regularly  adapts  the  Annexes  to  Regulation 
(EC) No 1272/2008  to  technical  and scientific progress.  According to  Article 53c  of 

8 

9 

10 

Regulation  (EU)  2022/2065  of  the  European  Parliament  and  of  the  Council  of  19  October  2022  on a 
Single Market  For Digital Services and amending Directive  2000/31/EC (Digital Services Act) (OJ L 
277, 27.10.2022, p. 1). 
Regulation (EC) No 1907/2006 of the European Parliament  and of the Council of 18 December 2006 
concerning  the  registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1). 
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). 

EN 

27 

  EN 

                                                 
(33) 

that Regulation, the Commission is to adopt a separate delegated act in respect of each 
power  delegated  to  it.  It  has  been  difficult  to  apply  that  provision  when  amending 
different  parts  of  Annex  VI  to  Regulation  (EC)  No  1272/2008  that  are  subject  to 
different empowerments. In particular in the case of simultaneous introduction of new 
notes  into  Part  1  of  Annex  VI  to  Regulation  (EC)  No  1272/2008  pertaining  to  new 
entries  in  Table  3  of  Part  3  of  Annex  VI  to  Regulation  (EC)  No  1272/2008  and  the 
introduction  of  new  entries  themselves  in  the  same  Annex,  adoption  of  separated 
delegated acts has resulted in artificially separating intrinsically related provisions and 
thereby  affecting  coherence  by  requiring  simultaneous  adoption  of  two  different  but 
related delegated acts. In such cases, it should be possible to adopt a single delegated 
act in respect of different delegated powers.  

it  is  necessary 

to  replace,  reduce  or  refine 

In  accordance  with  Directive  2010/63/EU  of  the  European  Parliament  and  of  the 
Council11, 
testing  on  animals. 
Implementation  of  Regulation  (EC)  No  1272/2008  should  be  based  on  the  use  of 
alternative  test  methods,  suitable  for  the  assessment  of  health  and  environmental 
classification  of  chemicals,  wherever  possible.  In  order  to  speed  up  the  transition  to 
non-animal methods, with the ultimate goal of fully replacing animal testing, as well 
as to improve the efficiency of chemical hazard assessments, innovation in the field of 
non-animal  methods  should  be  monitored  and  systematically  evaluated,  and  the 
Commission and the Member States acting in the interest of the Union should promote 
the  inclusion  of  harmonised  criteria  based  on  available  alternative  methods  in  UN 
GHS  and  subsequently  include  those  criteria  in  Regulation  (EC)  No  1272/2008 
without undue delay.  

(34)  Annex  VIII  to  Regulation  (EC)  No  1272/2008  provides  for  harmonised  information 
relating  to  emergency  health  response  and  preventative  measures  to  be  received  by 
appointed  bodies,  and  sets  forth  the  general  requirements,  the  information  to  be 
contained  in  a  submission,  the  submission  format  and  certain  standard  formulas.  In 
order to provide legal certainty and clarity on the option for submission of information 
relating to standardised mixtures and fuels in the context of Annex VIII to Regulation 
(EC) No 1272/2008, that Regulation should define the term ‘composition conforming 
with a standard formula’, the obligation to provide the name and product description 
of the standard formula in the submission and of the fuel should be introduced, and the 
option  to  submit  information  on  components  even  if  they  are  not  always  present  in 
certain cases should be provided for.  

(35) 

In order to provide further legal certainty and clarity of Annex VIII to Regulation (EC) 
No  1272/2008,  that  Regulation  should  further  specify  when  submission  updates  are 
required,  as  well  as  ways  of  identifying  the  mixture,  submitter  and  contact  point  by 
means of their product identifier. 

(36)  Regulation (EC) No 1272/2008 should therefore be amended accordingly. 

(37)  To  ensure  that  suppliers  of  substances  and  mixtures  have  time  to  adapt  to  rules  on 
classification,  labelling  and  packaging,  the  application  of  some  provisions  of  this 
Regulation should be deferred. Substances and mixtures which are already placed on 
the market before the end of that deferral period, should be allowed to continue being 
placed  on  the  market  without  being  re-classified  and  re-labelled  in  accordance  with 
this Regulation, to avoid additional burden on suppliers of substances and mixtures.  

11 

Directive  2010/63/EU  of  the  European  Parliament  and  of  the  Council  of  22  September  2010  on  the 
protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33). 

EN 

28 

  EN 

                                                 
(38) 

In line with the transitional provisions of Regulation (EC) No 1272/2008 which allow 
the application of the new provisions at an earlier stage on a voluntary basis, suppliers 
should have the possibility of applying the new classification, labelling and packaging 
provisions  on  a  voluntary  basis  before  the  date  of  deferred  application  of  this 
Regulation. 

(39)  Since the objectives of this Regulation cannot be sufficiently achieved by the Member 
States, because environmental pollution is transboundary and the citizens of the Union 
should benefit from an equal protection of their health and environment  and because 
substances and mixtures should circulate freely on the Union market , but can rather, 
by  reason  of  their  scale,  be  better  achieved  at  Union  level,  the  Union  may  adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty on European Union. In accordance with the principle of proportionality, as set 
out  in  that Article, this Regulation  does  not  go  beyond what  is  necessary  in  order to 
achieve those objectives,  

HAVE ADOPTED THIS REGULATION: 

Regulation (EC) No 1272/2008 is amended as follows:  

(1) 

in Article 1(1), the following point (f) is added:  

Article 1 

‘(f)  providing  an  obligation  for  downstream  users,  importers  and  distributors 
referred to in Article 45(1) to submit information relevant for providing an adequate 
emergency health response to appointed bodies in accordance with Annex VIII.’; 

(2) 

in Article 2, the following points 7a and 38 are added: 

‘7a.  ‘multi-constituent  substance’  means  a  substance  that  contains  more  than  one 
constituent.  

38.  ‘acute  toxicity  estimates’  means  numeric  criteria  according  to  which  substances 
and mixtures are classified in one of four acute toxicity hazard categories based on the 
oral, dermal or inhalation exposure route.’; 

(3) 

in Article 4, paragraph 10 is replaced by the following:  

‘10. A substance or a mixture shall not be placed on the market unless a supplier has 
ensured in the course of an industrial or professional activity that the substance or the 
mixture fulfils the requirements set out in this Regulation.’; 

(4) 

in Article 5, the following paragraph 3 is added:  

‘3. A multi-constituent substance containing at least one constituent, in the form of 
an  individual  constituent,  an  identified  impurity  or  an  additive  for  which  relevant 
information referred to in paragraph 1 is available, shall be examined in accordance 
with  the  criteria  set  out  in  this  paragraph,  using  the  available  information  on  those 
constituents  as  well  as  on  the  substance,  unless  Annex  I  lays  down  a  specific 
provision.  

For the evaluation of multi-constituent substances pursuant to Chapter 2 in relation to 
the  ‘germ  cell  mutagenicity’,  ‘carcinogenicity’,  ‘reproductive  toxicity’,  ‘endocrine 
disrupting  property  for  human  health’  and  ‘endocrine  disrupting  property  for  the 
environment’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1. 
and 4.2.3.1. of Annex I, the manufacturer, importer or downstream user shall use the 

EN 

29 

  EN 

relevant  available  information  referred  to  in  paragraph  1  for  each  of  the  individual 
constituents in the substance.  

Relevant  available  information  on  the  multi-constituent  substance  itself  shall  be 
taken into account where one of the following conditions are met:   

(a) 

the information demonstrates germ cell mutagenic, carcinogenic, or toxic 
to reproduction properties, or endocrine disrupting properties for human 
health or the environment; 

(b) 

the information supports the conclusions based on the relevant available 
information on the constituents in the substance. 

Relevant  available  information  on  the  multi-constituent  substance  itself  showing 
absence of certain properties or less severe properties shall not override the relevant 
available information on the constituents in the substance.  

For the evaluation of multi-constituent substances pursuant to Chapter 2 in relation to 
the ‘biodegradation, persistence, mobility and bioaccumulation’ properties within the 
‘hazardous to the aquatic environment’ ‘persistent, bioaccumulative and toxic’, ‘very 
persistent  and  very  bioaccumulative’,  ‘persistent,  mobile  and  toxic’  and  ‘very 
persistent  and  very  mobile’  hazard  classes  referred  to  in  sections  4.1.2.8  4.1.2.9, 
4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or 
downstream user shall use the relevant available information referred to in paragraph 
1 for each of the individual constituents in the substance.  

Relevant  available  information  on  the  multi-constituent  substance  itself  shall  be 
taken into account where one of the following conditions are met: 

(a) 

(b) 

the  information  demonstrates  biodegradation,  persistence,  mobility  and 
bioaccumulation properties. 

the information supports the conclusions based on the relevant available 
information on the constituents in the substance. 

Relevant  available  information  on  the  multi-constituent  substance  itself  showing 
absence of certain  properties or less  severe properties shall not override  the relevant 
available information on the constituents in the substance. 

(5) 

in Article 6, paragraphs 3 and 4 are replaced by the following: 

‘3. For the evaluation of mixtures pursuant to chapter 2 in relation to the ‘germ cell 
mutagenicity’,  ‘carcinogenicity’,  ‘reproductive  toxicity’,  ‘endocrine  disrupting 
property for human health’ and ‘endocrine disrupting property for the environment’ 
hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1 and 4.2.3.1 of 
Annex I, the manufacturer, importer or downstream user shall  only use the relevant 
available information referred to in paragraph 1 for the substances in the mixture and 
not for the mixture itself . 

However, where the available test data on the mixture itself demonstrates germ cell 
mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disrupting 
properties for human health or the environment which have not been identified from 
the relevant available information on the individual substance referred to in the first 
subparagraph,  that  data  shall  also  be  taken  into  account  for  the  purposes  of  the 
evaluation of the mixture referred to in the first subparagraph. 

4.  For  the  evaluation  of  mixtures  pursuant  to  Chapter  2  in  relation  to  the 
‘biodegradation,  persistency,  mobility  and  bioaccumulation’  properties  within  the 

EN 

30 

  EN 

‘hazardous  to  the  aquatic  environment’,  ‘persistent,  bioaccumulative  and  toxic’, 
‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very 
persistent  and  very  mobile’  hazard  classes  referred  to  in  sections  4.1.2.8,  4.1.2.9, 
4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I, the manufacturer, importer or 
downstream  user  shall  only  use  the  relevant  available  information  referred  to  in 
paragraph 1  for the substances in the mixture and not for the mixture  itself ’; 

(6) 

in Article 9, paragraphs 3 and 4 are replaced by the following:  

‘3.  Where  the  criteria  referred  to  in  paragraph  1  cannot  be  applied  directly  to 
available  identified  information,  manufacturers,  importers  and  downstream  users 
shall carry out  an evaluation by applying a weight  of evidence determination using 
expert  judgement  in  accordance  with  section  1.1.1  of  Annex  I  to  this  Regulation, 
weighing  all  available  information  having  a  bearing  on  the  determination  of  the 
hazards of the substance or the mixture, and in accordance with section 1.2 of Annex 
XI to Regulation (EC) No 1907/2006. 

4.  When  evaluating  hazard  information  for  mixtures,  manufacturers,  importers  and 
downstream  users  shall,  where  test  data  for  the  mixture  itself  are  inadequate  or 
unavailable, apply the bridging principles referred to in section 1.1.3. of Annex I and 
in each section of Parts 3 and 4 of that Annex for the purposes of the evaluation.  

When  applying  the  bridging  principles,  manufacturers,  importers  and  downstream 
users  may  integrate  a  weight  of  evidence  determination  using  expert  judgement  in 
accordance with section 1.1.1. of Annex I to this Regulation, weighing all available 
information having a bearing on the determination of the hazards of the mixture, and 
in accordance with section 1.2. of Annex XI to Regulation (EC) No 1907/2006. The 
rules on bridging principles in section 1.1.3 of Annex I shall remain applicable even 
in a weight of evidence determination. 

When evaluating the hazard information for mixtures, manufacturers, importers and 
downstream users shall, where that information does not permit the application of the 
bridging principles in  accordance with  the first  and second subparagraphs, evaluate 
the information by applying the other method or methods set out in Parts 3 and 4 of 
Annex I.’; 

(7) 

Article 10 is replaced by the following: 

‘Article 10 

Concentration limits, M-factors and acute toxicity estimates for classification of 
substances and mixtures 

1. 

Specific  concentration  limits  and  generic  concentration  limits  are  limits 
assigned to a substance indicating a threshold at  or above which the presence 
of that substance in another substance or in a mixture as an identified impurity, 
additive or individual constituent leads to the classification of the substance or 
mixture as hazardous. 

Specific  concentration  limits  shall  be  set  by  the  manufacturer,  importer  or 
downstream user where adequate and reliable scientific information shows that 
the  hazard  of  a  substance  is  evident  when  the  substance  is  present  at  a  level 
below the concentrations set for any hazard class in Part 2 of Annex I or below 
the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of 
Annex I. 

EN 

31 

  EN 

In  exceptional  circumstances  specific  concentration  limits  may  be  set  by  the 
manufacturer, importer or downstream user where that manufacturer, importer 
or downstream user has adequate, reliable and conclusive scientific information 
that  a  hazard  of  a  substance  classified  as  hazardous  is  not  evident  at  a  level 
above the concentrations set for the relevant hazard class in Part 2 of Annex I 
or  above  the  generic  concentration  limits  set  for  the  relevant  hazard  class  in 
Parts 3, 4 and 5 of that Annex. 

2.  M-factors  for  substances  classified  as  hazardous  to  the  aquatic  environment, 
acute category 1 or chronic category 1, shall be established by manufacturers, 
importers and downstream users. 

3.  Acute  toxicity  estimates  for  substances  classified  as  acutely  toxic  for  human 
health shall be established by manufacturers, importers and downstream users. 

4. 

5. 

6. 

By way of derogation from paragraph 1, specific concentration limits shall not 
be set for harmonised hazard classes or differentiations for substances included 
in Part 3 of Annex VI for which a specific concentration limit is given in that 
Part. 

By way of derogation from paragraph 2, M-factors shall not be established for 
harmonised hazard classes or differentiations for substances included in Part 3 
of Annex VI for which an M-factor is given in that Part. 

By  way  of  derogation  from  paragraph  3,  acute  toxicity  estimates  shall  not  be 
established  for  harmonised  hazard  classes  or  differentiations  for  substances 
included in Part 3 of Annex VI for which an acute toxicity estimate is given in 
that Part. 

7.  When  setting  the  specific  concentration  limit,  M-factor  or  acute  toxicity 
estimate,  manufacturers,  importers  and  downstream  users  shall  take  into 
account any specific concentration limits, M-factors or acute toxicity estimate 
for that substance which have been included in the classification and labelling 
inventory. 

However, where an M-factor is not given in Part 3 of Annex VI for substances 
classified as hazardous to the aquatic environment, acute category 1 or chronic 
category 1, an M-factor based on available data for the substance shall be set 
by the manufacturer, importer or downstream user. When a mixture including 
the  substance  is  classified  by  the  manufacturer,  importer  or  downstream  user 
using the summation method, this M-factor shall be used. 

8. 

Specific  concentration  limits  set  in  accordance  with  paragraph  1  shall  take 
precedence over the concentration limits set out in the relevant sections of Part 
2 of Annex I or the generic concentration limits for classification set out in the 
relevant sections of Parts 3, 4 and 5 of that Annex. 

9. 

The Agency shall provide further guidance for the application of paragraphs 1, 
2 and 3. 

10.  Where a mixture contains  a substance which is  classified as hazardous solely 
due to the presence of an identified impurity, additive or individual constituent, 
the  concentration  limits  referred  to  in  paragraph  1  shall  apply  to  the 
concentration  of  that  identified  impurity,  additive  or  individual  constituent  in 
the mixture. 

EN 

32 

  EN 

11.  Where a mixture contains another mixture, the concentration limits referred to 
in  paragraph  1  shall  apply  to  the  concentration  of  the  identified  impurity, 
additive  or  individual  constituent  referred  to  in  paragraph  10  in  the  resulting 
final mixture.’; 

(8) 

in Article 23, the following point (g) is added:  

‘(g) ammunition as defined in Article 1(1), point (3), of Directive (EU) 2021/555 of 
the European Parliament and of the Council* unless it falls within the definition of 
an article in Article 2, point (9), of this Regulation. 

*  Directive  (EU)  2021/555  of  the  European  Parliament  and  of  the  Council  of  24 
March  2021  on  control  of  the  acquisition  and  possession  of  weapons  (OJ  L  115, 
6.4.2021, p. 1).’; 

(9) 

Article 25 is amended as follows:  

(a) 

in paragraph 6, the first subparagraph is replaced by the following:  

(10) 

‘6. The specific labelling rules set out in Part 2 of Annex II shall apply to mixtures 
containing substances referred to in that Annex.’; 

(a) 

the following paragraph 9 is added: 

‘9.  Label  elements  resulting from requirements  set  out  in  other Union acts  shall be 

placed in the section for supplemental information on the label.’; 

(11) 

Article 29 is amended as follows: 

(a) 

paragraph 1 is replaced by the following:  

‘1. Where the packaging of a substance or a mixture is either in such a shape or form 
or is so small that it is impossible to meet the requirements laid down in Article 31 
for  a  label  or  a  fold-out  label  in  the  languages  of  the  Member  State  in  which  the 
substance  or  mixture  is  placed  on  the  market,  the  label  elements  set  out  in  Article 
17(1), shall be provided  in  accordance with  sections 1.5.1.1. and 1.5.1.2. of Annex 
I.’; 

(b)  paragraph 3 is replaced by the following:  

‘3.  Where  a  hazardous  substance  or  mixture  referred  to  in  Part  5  of  Annex  II  is 
supplied to the general public without packaging, the labelling information shall be 
provided  in  accordance  with  the  provision  referring  to  that  substance  or mixture  in 
that Part.’; 

(c) 

the following paragraphs 4b and 4c are inserted:  

‘4b.  By  derogation  from  Article  17(1),  the  labelling  requirement  set  out  in  that 
Article shall not apply to packaging of ammunition that is used by defence forces in 
combat  zones  or  shipped  to  such  zones  where  labelling  in  accordance  with  that 
requirement would constitute an unacceptable security risk for the cargo, the soldiers 
and the staff, and sufficient camouflaging cannot be ensured.  

4c. Where paragraph 4b applies, manufactures, importers or downstream users shall 
provide  to  the  defence  force  the  safety  data  sheet  or  a  leaflet  containing  the 
information referred to in Article 17(1).’; 

(12) 

Article 30 is replaced by the following: 

EN 

33 

  EN 

 
‘Article 30 

Updating information on labels 

1. In case of a change  regarding the classification and labelling of a substance or a 
mixture,  which  results  in  the  addition  of  a  new  hazard  class  or  in  a  more  severe 
classification,  or  which  requires  new  supplemental  information  on  the  label  in 
accordance with Article 25, the supplier shall ensure that the label is updated within 
6  months  after  the  results  of  the  new  evaluation  referred  to  in  Article  15(4)  were 
obtained.  

2.  Where  a  change  regarding  the  classification  and  labelling  of  a  substance  or  a 
mixture  is  required  other  than  that  referred  to  in  paragraph  1,  the  supplier  shall 
ensure  that  the  label  is  updated  within  18  months  after  the  results  of  the  new 
evaluation referred to in Article 15(4) were obtained. 

3. Paragraphs 1 and 2 shall not apply where a change regarding the classification and 
labelling  of  a  substance  or  a  mixture  was  triggered  by  a  harmonised  classification 
and  labelling  of  a  substance  set  out  in  a  delegated  act  adopted  pursuant  to  Article 
37(5) or by a provision set out in a delegated act adopted pursuant to Article 53(1). In 
such cases, the supplier shall ensure that the label is updated by the date set out in the 
respective delegated act. 

4.  The  supplier  of  a  substance  or  mixture  that  falls  within  the  scope  of  Regulation 
(EC)  No  1107/2009  or  Regulation  (EU)  No  528/2012  shall  update  the  label  in 
accordance with those Regulations’; 

(13) 

in Article 31(3), the following sentence is added: 

‘3.  The  label  elements  referred  to  in  Article  17(1)  shall  be  clearly  and  indelibly 
marked. They shall stand out clearly from the background and they shall be of such 
size  and  spacing  as  to  be  easily  read.  They  shall  be  formatted  in  accordance  with 
section 1.2.1 of Annex I.’; 

(14) 

(15) 

in Article 32, paragraph 6 is deleted;  

in Title III, the following Chapter 3 is added: 

‘CHAPTER 3 

Formats of the labelling 

Article 34a 

Physical and digital labelling 

1. The label elements referred to in Article 17 shall be provided:  

(a) on a label in a physical form (‘physical label’); or  

(b) both on a physical label and on a label in a digital form (‘digital label’). 

2.  By  way  of  derogation  from  paragraph  1,  the  suppliers  may  provide  the  label 
elements set out in section 1.6. of Annex I on a digital label only. 

EN 

34 

  EN 

 
 
 
 
Article 34b 

Requirements for digital labelling 

1.  The  digital  label  for  substances  and  mixtures  shall  satisfy  the  following  general 
rules and technical requirements: 

(a) 

all label elements referred to in Article 17(1) shall be provided in one place and 
separated from other information;  

(b) 

the information on the digital label shall be searchable; 

(c) 

(d) 

(e) 

(f) 

(g) 

the information on the digital label shall be accessible to all users in the Union,  

the digital label shall be accessible free of charge, without the need to register, 
download or install applications, or to provide a password;  

the  information  on  the  digital  label  shall  be  presented  in  a  way  that  also 
addresses  the  needs  of  vulnerable  groups  and  support,  as  relevant,  the 
necessary adaptations to facilitate access to the information by those groups; 

the information on the digital label shall be accessible with no more than two 
clicks; 

the  digital  label  shall  be  accessible  through  digital  technologies  widely  used 
and compatible with all major operating systems and browsers;  

(h)  when  the  digital  label  is  available  in  more  than  one  language,  the  choice  of 

language shall not be conditioned on the geographical location; 

(i) 

(j) 

the  link  to  the  digital  label  shall  be  printed  or  placed  physically,  visibly  and 
legibly on the product in such a way that it can be processed automatically by 
digital devices widely used by consumers; 

the digital label shall remain available for a period of 10 years, including after 
an  insolvency,  a  liquidation  or  a  cessation  of  activity  in  the  Union  of  the 
supplier  that  created  it,  or  for  such  longer  period  required  under  other  Union 
legislation covering the information that it contains.  

2. Suppliers shall provide, on oral or written demand or when the digital label is temporarily 
unavailable at the time of purchase of the substance or mixture, the label elements provided 
on a digital label only in accordance with Article 34a(2) by alternative means. Suppliers shall 
provide those elements independently of a purchase and free of charge. 

3. It is prohibited to track, analyse or use any usage information for purposes  going beyond 
what is absolutely necessary for provision of digital labelling’; 

(16) 

in Article 35, the following paragraph 2a is added: 

‘2a.  Hazardous  substances  or  mixtures  may  be  supplied  to  consumers  and 
professional users via refill stations only if, in addition to the requirements set out in 
Titles III and IV, the conditions laid down in section 3.4 of Annex II are fulfilled.’; 

(17) 

in Article 36, paragraph 1 is amended as follows:  

(a) 

point (a) is replaced by the following: 

‘(a) respiratory sensitisation, category 1, 1A or 1B (Annex I, section 3.4.)’;  

EN 

35 

  EN 

 
 
(b) 

the following points (e) to (j) are added: 

‘(e)  endocrine disruption for human health, category 1 or 2 (Annex  I, section 

3.11.); 

(f) endocrine disruption for the environment, category 1 or 2 (Annex I, section 

4.2.); 

(g) persistent, bioaccumulative and toxic (PBT) (Annex I, section 4.3.); 

(h) very persistent, very bioaccumulative (vPvB) (Annex I, section 4.3.); 

(i) persistent, mobile and toxic (PMT) (Annex I, section 4.4.); 

(j) very persistent, very mobile (vPvM) (Annex I, section 4.4).’; 

(c) 

paragraph 2 is replaced by the following: 

‘2. Substances that are active substances falling within the scope of Regulation (EC) 
No  1107/2009  or  Regulation  (EU)  528/2012  shall  be  subject  to  harmonised 
classification  and  labelling.  For  such  substances,  the  procedures  set  out  in  Article 
37(1), (4), (5) and (6) shall apply.’; 

(18) 

Article 37 is amended as follows:  

(a) 

paragraph 1 is replaced by the following: 

‘1.  A  competent  authority  may  submit  to  the  Agency  a  proposal  for  harmonised 
classification  and 
labelling  of  substances  and,  where  appropriate,  specific 
concentration limits, M-factors or acute toxicity estimates, or a proposal for revision 
thereof. 

The  Commission  may  ask  the  Agency  or  the  European  Food  Safety  Authority 
established  in  accordance  with  Article  1(2)  of  Regulation  (EC)  No  178/2002*  to 
prepare  a  proposal  for  harmonised  classification  and  labelling  of  substances  and, 
where  appropriate,  specific  concentration  limits,  M-factors  or  acute  toxicity 
estimates,  or  a  proposal  for  revision  thereof.  The  Commission  may  subsequently 
submit the proposal to the Agency.  

The proposals referred to in the first and the second subparagraphs shall follow the 
format set out in Part 2 of Annex VI and contain the relevant information provided 
for in Part 1 of Annex VI. 

* Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 
January  2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing  the  European  Food  Safety  Authority  and  laying  down  procedures  in 
matters of food safety (OJ L 31, 1.2.2002, p.1)’; 

(b) 

in paragraph 2, the first subparagraph is replaced by the following:  

‘2.  Manufacturers,  importers  or  downstream  users  of  substances  may  submit  to  the 
Agency  a  proposal  for  harmonised  classification  and  labelling  of  those  substances 
and,  where  appropriate,  specific  concentration  limits,  M-factors  or  acute  toxicity 
estimates, provided that there is no entry in Part 3 of Annex VI for such substances in 
relation to the hazard class or differentiation covered by that proposal.’;  

(c) 

 the following paragraph 2a is inserted: 

EN 

36 

  EN 

 
 
 
 
 
 
‘2a.  Before  submitting  a  proposal  to  the  Agency,  a  competent  authority, 
manufacturer, importer or downstream user shall notify the Agency of its intention to 
submit a proposal for harmonised classification and labelling and, in the case of the 
Commission,  the  request  to  the  Agency  or  the  European  Food  Safety  Authority  to 
prepare such proposal.  

Within one week from receipt of the notification, the Agency shall publish the name 
and, where relevant, the EC and CAS numbers of the substance(s), the status of the 
proposal and the name of the submitter. The Agency shall update the information on 
the status of the proposal after completion of each stage of the process referred to in 
Article 37(4) and (5). 

Where a competent authority receives a proposal in accordance with paragraph 6, it 
shall  notify  the  Agency  and  provide  any  relevant  information  on  its  reason  for 
accepting or refusing the proposal. The Agency shall share that information with the 
other competent authorities.’; 

(d)  paragraph 3 is replaced by the following: 

‘3. Where the proposal  of the manufacturer, importer or downstream  user concerns 
the harmonised classification and labelling of substances in accordance with Article 
36(3),  it  shall  be  accompanied  by  the  fee  determined  by  the  Commission  in 
accordance with the procedure referred to in Article 54(2).’; 

(e) 

paragraphs 5 and 6 are replaced by the following:  

‘5. The Commission  shall  adopt  without undue delay,  delegated  acts  in  accordance 
with  Article  53a  to  amend  Annex  VI  by  inclusion  of  substances  together  with  the 
relevant  classification  and  labelling  elements  and,  where  appropriate,  the  specific 
concentration  limits,  M-factors  or  acute  toxicity  estimates  in  Table  3  of  Part  3  of 
Annex VI. 

Where,  in  the  case  of  harmonisation  of  classification  and  labelling  of  substances, 
imperative grounds of urgency so require, the procedure provided for in Article 53b 
shall apply to delegated acts adopted pursuant to this paragraph. 

6. Manufacturers, importers and downstream users who have new information which 
may  lead  to  a  change  of  the  harmonised  classification  and  labelling  elements  of 
substances  in  Part  3  of  Annex  VI  shall  submit  a  proposal  in  accordance  with 
paragraph 2, second subparagraph, to the competent authority in one of the Member 
States in which the substances are placed on the market.’; 

(f) 

The following paragraphs 7 and 8 are inserted: 

‘7.  The  Commission  shall  adopt  delegated  acts  in  accordance  with  Article  53a  to 
amend Table 3 of Part 3 of Annex VI to this Regulation by inclusion of substances  
as  endocrine  disruptor  category  1  for  human  health  properties,  endocrine  disruptor 
category 1 for environment properties, as persistent, bioaccumulative and toxic or as 
very  persistent  and  very  bioaccumulative  together  with  relevant  classification  and 
labelling elements where, on … [OP: please insert the date = the date of  entry into 
force  of  Commission  Delegated  Regulation  (EU)  …i.e.  delegated  act  on  the  new 
hazard  classes  -  reference  to  be  added  once  adopted],  those  substances  have  been 
included  in  the  candidate  list  referred  to  in  Article  59(1)  of  Regulation  (EC)  No 
1907/2006.  

The inclusion of the substances, referred to  in  the first  subparagraph, in  Table 3 of 
Part  3  of  Annex  VI  to  this  Regulation  shall  be  carried  out  on  the  basis  of  the 

EN 

37 

  EN 

  
respective criteria for which those substances have been included in the candidate list 
referred to in Article 59(1) of Regulation (EC) No 1907/2006.’ 

8.  The  Commission  shall  adopt  delegated  acts  in  accordance  with  Article  53a  to 
amend  Table  3  of  Part  3  of  Annex  VI  by  inclusion  of  substances  together  with 
relevant classification and labelling elements where, on … [OP: please insert the date 
=  the  date  of  entry  into  force  of  Commission  Delegated  Regulation  (EU)  …i.e.  the 
delegated act on the new hazard classes - reference to be added once adopted] those 
substances  have  not  been  approved,  under  Regulation  (EC)  No  1107/2009  or 
Regulation (EU) No 528/2012 or have been approved with derogation in accordance 
with  the  relevant  provisions  of  those  Regulations,  due  to  either  of  the  following 
characteristics: 

endocrine disruptor in accordance with Section 3.6.5 or Section 3.8.2 of 

(a) 
Annex II to Regulation (EC) No 1107/2009; 

persistent,  bioaccumulative  and  toxic  or  very  persistent  and  very 
(b) 
bioaccumulative  in  accordance  with  Section  3.7.2.  or  3.7.3.  of  Annex  II  to 
Regulation (EC) No 1107/2009; 

 endocrine  disruptor  for  human  health  or  for  the  environment  in 
(c) 
accordance  with  Article  1  of  Commission  Delegated  Regulation  (EU) 
2017/2100*; 

 persistent,  bioaccumulative  and  toxic  or  very  persistent  and  very 
(d) 
bioaccumulative in accordance with Article 5(1), point (e), of Regulation (EU) 
No 528/2012. 

The inclusion  of the substances, referred to  in  the first  subparagraph, in  Table 3 of 
Part 3 of Annex VI shall be carried out on the basis of the respective criteria that they 
meet in accordance with the acts referred to in that subparagraph, points (a) to (d).’; 

*  Commission  Delegated  Regulation  (EU)  2017/2100  of  4  September  2017  setting 
out  scientific  criteria  for  the  determination  of  endocrine-disrupting  properties 
pursuant  to  Regulation  (EU) No 528/2012  of the European Parliament and Council 
(OJ L 301 of 17.11.2017 p.1.’; 

(19) 

In Article 38(1), point (c) is replaced by the following: 

‘(c)  the  specific  concentration  limits,  M-factors  or  acute  toxicity  estimates,  where 
applicable;’; 

(20) 

Article 40 is amended as follows: 

(a) 

paragraph 1, the first subparagraph is amended as follows: 

(i) point (e) is replaced by the following:  

‘(e)  specific  concentration  limits,  M-factors  or  acute  toxicity  estimates,  where 
applicable, in accordance with Article 10, together with a justification referred to in 
the  relevant  parts  of  sections  1,  2  and  3  of  Annex  I  to  Regulation  (EC)  No 
1907/2006;’ 

(ii) points (g) and (h) are added: 

EN 

38 

  EN 

 
 
  
 
 
 
 
 
 
‘(g) where applicable, the reason for divergence from the most severe classification 
per hazard class included in the inventory referred to in Article 42; 

(h)  where  applicable,  the  reason  for  introducing  a  more  severe  classification  per 
hazard class compared to those included in the inventory referred to in Article 42.’; 

(b)  paragraph 2 is replaced by the following: 

‘2.  The  information  listed  in  paragraph  1  shall  be  notified  to  the  Agency  by  the 
notifier(s)  concerned  at  the  latest  6  months  after  a  decision  to  change  the 
classification  and  labelling  of  the  substance  has  been  taken  pursuant  to  the  review 
referred to in Article 15(1).’; 

(21) 

in Article 42(1), the third subparagraph is replaced by the following:  

‘3. The following information shall be made publicly available free of charge online:  

 (a) information referred to in Article 40(1), point (a), except where a notifier 
duly  justifies  why  such  publication  is  potentially  harmful  for  its 
commercial interests or the commercial interests of any other concerned 
party;  

(b)  in  the  case  of  group  notifications,  the  identity  of  the  importer  or 
manufacturer submitting the information on behalf of the other members 
of the group;  

(c) information in the inventory which corresponds to the information referred 

to in Article 119(1) of Regulation (EC) No 1907/2006. 

The  Agency  shall  grant  access  to  the  information  in  the  inventory  that  concerns  a 
substance and is  not  referred to  in  the first  subparagraph  to  other parties subject  to 
Article 118 of Regulation (EC) No 1907/2006.’;  

(22) 

Article 45 is amended as follows: 

(a) 

paragraph 1 is replaced by the following:  

‘1.  Member  States  shall  appoint  a  body  or  bodies  responsible  for  receiving  the 
relevant  harmonised  information  relating  to  emergency  health  response  and 
preventative measures, in accordance with Annex VIII.’; 

(b) 

the following paragraphs 1a, 1b and 1c are inserted:  

 ‘1a.  Member States  may  appoint the Agency as the body responsible for receiving 
information  relating  to  emergency  health  response  and  preventative  measures 
referred to in paragraph 1.’; 

1b.  Importers  and  downstream  users  placing  on  the  market  mixtures  that  are 
classified  as  hazardous  on  the  basis  of  their  health  effects  or  physical  effects,  shall 
submit  to  the  body  or  bodies  appointed  in  accordance  with  paragraph  1  the 
harmonised information referred to in Part B of Annex VIII. 

1c.  Distributors placing on the market mixtures that are classified as hazardous on 
the basis of their health effects or physical effects, shall submit to the appointed body 
or bodies the harmonised information referred to in Part B of Annex VIII where they 
further  distribute  those  mixtures  in  other  Member  States,  or  where  they  rebrand  or 
relabel  the  mixtures.  This  obligation  does  not  apply  if  the  distributors  can 

EN 

39 

  EN 

 
demonstrate that the appointed body or bodies already received the same information 
from importers or downstream users.’;  

(c) 

in paragraph 2, point (b) is replaced by the following: 

‘(b)  where  requested  by  a  Member  State,  the  Commission  or  the  Agency,  to 
undertake  a  statistical  analysis  to  identify  where  improved  risk  management 
measures may be needed.’; 

(d)  paragraph 3 is replaced by the following:  

‘3.  The  appointed  bodies  shall  have  at  their  disposal  all  the  information  required 
from  importers,  downstream  users  and  distributors  referred  to  in  paragraph  1c,  to 
carry out the tasks for which they are responsible.’; 

(23) 

Article 48 is replaced by the following: 

‘Article 48 

Advertisement 

1. 
Any  advertisement  for  a  substance  classified  as  hazardous  shall  indicate  the 
relevant  hazard  pictogram,  the  signal  word,  the  hazard  class  and  the  hazard 
statements. 

2. 
Any  advertisement  for  a  mixture  classified  as  hazardous  or  covered  by 
Article 25(6)  shall  indicate  the  hazard  pictogram,  the  signal  word,  the  hazard  class 
and the hazard statements. 

(24) 

the following Article 48a is added:  

‘Article 48a 

Distance sales offers 

Suppliers placing substances or mixtures on the market through distance sales shall 
clearly indicate the label elements referred to in Article 17.’; 

(25) 

Article 50 is amended as follows:  

(a) 

in paragraph 2, point (b) is replaced by the following: 

‘(b) provide competent authorities with technical and scientific guidance and tools on 
the  operation  and  implementation  of  this  Regulation  and  provide  support  to  the 
helpdesks established by Member States under Article 44.’; 

(b) 

the following paragraph 3 is added:  

‘3. Where the Agency acts as an appointed body in accordance with Article 45(1a), it 
shall  put  in  place  the  tools  necessary  to  provide  access  to  the  information  to  the 
relevant appointed body or bodies of the appointing Member State to fulfil their tasks 
with regard to emergency health response and preventative measures.’  

(26) 

Article 53 is amended as follows: 

(a) 

the following paragraphs 1a to 1b are inserted: 

‘1a.  The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  53a  to  amend  section  1.6.  of  Annex  I  in  order  to  adapt  the  label  elements 
referred to in Article 34a(2) to technical progress or to the level of digital readiness 
among all population groups in the Union. When adopting those delegated acts, the 

EN 

40 

  EN 

Commission shall take into account the societal needs and a high level of protection 
of human health and the environment; 

1b. In order to adjust to technological changes and (future) developments in the field 
of  digitalisation,  the  Commission  is  empowered  to  adopt  delegated  acts  in 
accordance  with  Article  53a  to  supplement  this  Regulation  by  laying  down  further 
details on the requirements for the digital labelling referred to in Article 34b. Those 
requirements shall cover, in particular, the IT solutions which may be used, and the 
alternative means for providing the information. When adopting those delegated acts, 
the Commission shall:  

(a) ensure coherence with other relevant Union acts;  

(b) encourage innovation; 

(c) ensure technological  neutrality by applying no constraints or prescriptions 
the  bounds  of 

technology  or  equipment,  within 

on  choices  of 
compatibility and interference avoidance;  

(d) take into account the level of digital readiness among all population groups 

in the Union; 

(e)  ensure  that  digitalisation  does  not  compromise  the  protection  of  human 

health and the environment. 

(b)  paragraph 2 is replaced by the following: 

‘2. The Commission or the Member States acting in the interest of the Union shall, in 
the  manner  appropriate  to  their  role  in  the  relevant  UN  fora,  promote  the 
harmonisation  of the criteria for  classification and labelling of endocrine  disruptors 
for  human  health,  endocrine  disruptors 
the  environment,  persistent, 
bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), 
persistent,  mobile  and  toxic  (PMT)  and  very  persistent  and  very  mobile  (vPvM) 
substances as well as alternative test methods at the level of the UN.’; 

for 

(c) 

the following paragraph 3 is added: 

3.  The  Commission  shall  regularly  evaluate  the  development  of  alternative  test  methods 
referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances 
and mixtures.   

(27) 

Article 53a is amended as follows: 

(a) 

in paragraph 2, the first sentence is replaced by the following:  

‘The power to adopt delegated acts referred to in Articles 37(5), 37(7), 37(8), 45(4) 
53(1), 53(1a) and 53(1b) shall be conferred on the Commission for a period of five 
years from [OP please insert the date = the date of entry into force of this Regulation] 
’;   

(b) 

in paragraph 3, the first sentence is replaced by the following: 

‘The delegation of power referred to in Articles 37(5), 37(7) and 37(8), 45(4), 53(1), 
53(1a) and 53(1b), may be revoked at any time by the European Parliament or by the 
Council.’;  

(c) 

in paragraph 6, the first sentence is replaced by the following: 

‘A  delegated  act  adopted  pursuant  to    Articles  37(5),  37(7),  37(8),  45(4)  53(1), 
53(1a)  and  53(1b),  shall  enter  into  force  only  if  no  objection  has  been  expressed 

EN 

41 

  EN 

either by the European Parliament or by the Council within a period of two months 
of notification of that act to the European Parliament and the Council or if, before the 
expiry of that period, the European Parliament and the Council have both informed 
the Commission that they will not object.’; 

(28) 

Article 53c is replaced by the following:  

‘Article 53c 

Separate delegated acts for different delegated powers 

The  Commission  shall  adopt  a  separate  delegated  act  in  respect  of  each  power 
delegated  to  it  pursuant  to  this  Regulation,  with  the  exception  of  amendments  to 
Annex VI, where Parts 1 and 2 of that Annex may be amended together with Part 3 
of that Annex in one single act.’;  

(29) 

 Article 54 is replaced by the following:  

‘1.The Commission shall be assisted by the Committee established by Article 133 of 
Regulation  (EC)  No  1907/2006.  That  committee  shall  be  a  committee  within  the 
meaning of Regulation (EU) No 182/2011*.’;  

2.  Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

* Regulation (EU) 182/2011 …’; 

(30) 

in Article 61, the following paragraph 7 is added: 

‘7.  Substances  and  mixtures  which  have  been  classified,  labelled  and  packaged  in 
accordance  with  Article  1(1),  Article  4(10),  Article  5,  Article  6(3)  and  (4),  Article 
9(3)  and  (4),  Article  25(6)  and  (9),  Articles  29,  30  and  35,  Article  40(1)  and  (2), 
Article  42(1),  third  sub-paragraph,  Article  48,  section  1.2.1.  of  Annex  I,  section 
1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, 
the  first  sub-paragraph  of  section  2.4,  of  Annex  VIII,  Part  B,  section  1,  of  Annex 
VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of 
Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the 
first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex 
VIII, and Part D, sections 1, 2 and 3, of Annex VIII  as applicable on … [OP: please 
insert  the  date  =  the  day  before  the  entry  into  force  of  this  Regulation]  and  which 
were placed on the market before  [OP: please insert the date = the first  day of the 
month following 18 months after the date of entry into force of this Regulation ] are 
not  required  to  be  classified,  labelled  and  packaged  in  accordance  with  this 
Regulation as amended by Regulation …/…  of the European Parliament and of the 
Council*  [OP:  please  complete  the  reference  in  the    footnote  –  it  should  be  the 
reference to this Regulation]  until … [OP: please insert the date = the first day of the 
month following 42 months after the date of entry into force of this Regulation]. 

*  Regulation  (EU)  .../...  of  the  European  Parliament  and  of  the  Council  of  ...  on  ... 
(OJ ...).’; 

(31) 

(32) 

(33) 

Annex I is amended as set out in Annex I to this Regulation; 

Annex II is amended as set out in Annex II to this Regulation; 

Annex VIII is amended as set out in Annex III to this Regulation. 

EN 

42 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX I 

Part 1 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:  

(1)  Section 1.1.1.3. is replaced by the following:  

‘1.1.1.3.  A  weight  of  evidence  determination  means  that  all  available  information 
bearing on the determination of hazard is considered together, such as the results of 
suitable in vitro tests, relevant animal data, human experience such as occupational 
data and data from accident databases, epidemiological and clinical studies and well-
documented  case  reports  and  observations.  For  substances,  information  from  the 
application of the category approach (grouping, read-across) and (Q)SAR results are 
also  considered.  The  quality  and  consistency  of  the  data  shall  be  given  appropriate 
weight. Information on substances related to the substance being classified shall be 
considered,  as  appropriate.  Information  on  substances  or  mixtures  related  to  the 
mixture  being  classified  shall  be  considered  in  accordance  with  Article  9(4). 
Information on the site of action and the mechanism or mode of action study results 
shall  also  be  considered.  Both  positive  and  negative  results  shall  be  assembled 
together in a single weight of evidence determination.’;  

(2)  Section 1.2.1.4. is replaced by the following:  

‘1.2.1.4. 
letters shall be as follows:  

The dimensions of the label and of each pictogram, and the font size of 

Minimum dimensions of labels, pictograms and font size 

Table 1.3 

Capacity  of 
package  

the 

Dimensions  of  the  label 
(in  millimetres)  for  the 
information  required  by 
Article 17 

Dimensions  of 
pictogram 
millimetres) 

each 
(in 

Minimum font-size 

Not exceeding 3 
litres:  

If  possible,  at  least 
52x74 

Not  smaller 
10x10 

than 

8pt 

If  possible,  at  least 
16x16 

At least 74x105 

At least 23x23 

12pt 

At least 105x148 

At least 32x32 

16pt 

At least 148x210 

At least 46x46 

20pt’; 

Greater  than  3 
litres  but  not 
exceeding 
50 
litres:  

Greater  than  50 
litres  but  not 
exceeding  500 
litres:  

Greater than 500 
litres: 

EN 

43 

  EN 

 
 
(3) 

the following Section 1.2.1.5. is added:  

‘1.2.1.5.  

The text on the label shall have the following characteristics: 

(a) 

(b) 

(c) 

(d) 

the background of the label shall be white;  

the distance between two lines shall be equal or above 120 % of the font 
size; 

a single font shall be used that is easily legible and without serifs;  

the  letter  spacing  shall  be  appropriate  for  the  selected  font  to  be 
comfortably legible.  

For the labelling of inner packaging where the contents do not exceed 10 ml, the font 
size may be smaller than indicated in  Table 1.3, as long  as it remains  legible  for  a 
person with average eyesight, where itis deemed important to place the most critical 
hazard  statement  and  where  the  outer  packaging  meets  the  requirements  of  Article 
17.’ 

(4) 

the following Section 1.3.7. is added:  

‘1.3.7.  

Ammunition  

In  the  case  of  ammunition  that  qualifies  as  a  substance  or  mixture  and  that  is  shot 
through  a  firearm,  the  labelling  elements  may  be  provided  on  the  intermediate 
packaging  instead  of  on  the  inner  packaging,  or,  if  there  is  no  intermediate 
packaging, on the outer packaging.’;  

(5) 

the heading of Section 1.5.1. is replaced by the following:  

‘1.5.1.  

Exemptions from Article 31 in accordance with Article 29(1)’ 

(6)  Section 1.5.1.1. is replaced by the following:  

‘1.5.1.1.   Where Article 29(1) applies, the label elements referred to in Article 17 
may be provided on a tie-on tag or on an outer packaging.’; 

(7)  Section 1.5.1.2. is replaced by the following:  

‘1.5.1.2.  Where  section  1.5.1.1.  applies,  the  label  on  any  inner  packaging  shall 
contain at least hazard pictograms, the signal word, the trade name or the designation 
of  the  mixture  referred  to  in  Article 18(3),  point  (a),  and  the  name  and  telephone 
number of the suppliers of the substance or mixture.’; 

(8) the heading of Section 1.5.2 is replaced by the following: 

‘1.5.2. 

Exemptions from Article 17 in accordance with Article 29(2)’; 

(9) Section 1.5.2.4.1 is replaced by the following:  

 ‘1.5.2.4.1 The label elements required by Article 17 may be omitted from the inner 
packaging where the contents of the inner packaging do not exceed 10 ml and either 
of the following applies: 

(a)  

the  substance  or  mixture  is  placed  on  the  market  for  supply  to  a 
distributor or downstream user for scientific research and development or 
quality control analysis and the inner packaging is contained within outer 
packaging that meets the requirements set out in Article 17; 

EN 

44 

  EN 

 
(b)  

the  substance  or  mixture  does  not  require  labelling  in  accordance  with 
Part  1,  2  or  4  of  Annex  II  and  is  not  classified  in  any  of  the  following 
hazard classes and categories: 

(i) Acute toxicity, categories 1 to 4; 

(ii) Specific target organ toxicity – Single exposure, categories 1 and  

2; 

(iii) Specific target organ toxicity – repeated exposure, categories 1  

and 2; 

(iv) Skin corrosion/irritation, category 1 (sub-categories 1A, 1B and 1C); 

(v) Respiratory sensitisation, category 1 (sub-categories 1A and 1B); 

(vi) Aspiration hazard; 

(vii)Germ cell mutagenicity, any category; 

(viii)Carcinogenity, any category; 

(ix) Reproductive toxicity, any category;  

(x) Flammable solids, categories 1 and 2.; 

(xi) Endocrine disruptors for human health, any category; 

(c) 

the substance or mixture requires labelling in accordance with Part 1, 2 or 
4  of  Annex  II  but  is  not  classified  in  any  of  the  hazard  classes  and 
categories  referred  to  in  point  (b)  and  has  an  inner  packaging  that  is 
contained within outer packaging that meets  the  requirements set  out  in 
Article 17.’; 

(10) the following Section 1.6. is added:  

‘1.6. Label elements that may be provided on a digital label only  

(a)  Supplemental information referred to in Article 25(3)’; 

ANNEX II 

Annex II to Regulation (EC) No 1272/2008 is amended as follows:  

(1) 

in Part 3, the following Section 3.4. is added: 

‘3.4. Refill stations 

Hazardous  substances  or  mixtures  referred  to  in  Article  35(2a),  shall  meet  the 
following conditions:  

(a) the labelling and packaging requirements  applicable at the date of placing 
on  the  market  of  the  hazardous  substance  or  mixture  are  fulfilled  for 
every refill station; 

(b)  a  label  is  firmly  affixed  on  a  visible  place  of  the  refill  station  and  with  a 

font size that is easily legible and without serifs; 

EN 

45 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
(c)  substances  and  mixtures  are  only  refilled  in  suitable  and  clean  packaging 
without  any  visible  residues,  which  are  cleaned  before  reuse  in  case  of 
suspected microbiological or other invisible contamination; 

(d) the buttons to operate the refill station are out of reach of children and the 

refill station is not designed in a way to attract the curiosity of children;  

(e) overfilling packaging is technically prevented; 

(f)  filling  a  substance  or  mixture  into  unsuitable  packaging  is  technically 

prevented; 

(g) at the moment of refill, the supplier is reachable for immediate assistance;  

(h) refill  stations  are  not operated outdoors and  outside business  hours  where 

immediate assistance cannot be provided; 

(i) the substances or mixtures provided through a refill station do not react with 

each other in a way that could endanger clients or staff; 

(j)  staff  of  the  supplier  are  appropriately  trained  to  minimise  safety  risks  to 
consumers, professional users and themselves, and follow the necessary 
hygiene and cleaning protocols; 

(k) no substance or mixture provided through a refill station meets the criteria 

for classification in any of the following hazard classes:  

(i) Acute toxicity, categories 1 – 4;  

(ii) Specific target organ toxicity – Single exposure, categories 1, 2 and 3; 

(iii) Specific target organ toxicity – repeated exposure, categories 1 and 2; 

(iv) Skin corrosion/irritation, category 1 (sub-categories 1A, 1B and 1C);  

(v) Respiratory sensitisation, category 1 (sub-categories 1A and 1B);  

(vi) Aspiration hazard;  

(vii) Germ cell mutagenicity, any category;  

(viii) Carcinogenicity, any category; 

(ix) Reproductive toxicity, any category; 

(x) Flammable gases, categories 1 and 2; 

(xi) Flammable liquids, categories 1 and 2;  

(xii) Flammable solids, categories 1 and 2. 

(xiii) [insert: Endocrine disruptor for human health, categories 1 and 2].’; 

(xiv) [insert: Endocrine disruptor for the environment, category 1 and 2]; 

(xv) [insert: Persistent, bioaccumulative and toxic (PBT)]; 

(xvi) [insert: Very persistent and very bioaccumulative (vPvB)]; 

(xvii) [insert: Persistent, mobile and toxic (PMT)]; 

(xviii) [insert Very persistent and very mobile (vPvM)]. 

By way of derogation from point (b), a single label on the refill station may be used 
for several substances or mixtures for which the label elements referred to in Article 

EN 

46 

  EN 

17(1)  are  identical,  provided  that  the  label  clearly  indicates  the  name  of  each 
substance or mixture that it applies to.’; 

(2)  Part 5 is replaced by the following:  

‘PART  5:  HAZARDOUS  SUBSTANCES  AND  MIXTURES  TO  WHICH 
ARTICLE 29(3) APPLIES 

Ready mixed cement and concrete in the wet state shall be accompanied by a copy of the label 
elements in accordance with Article 17.  

For a substance or a mixture supplied at a filling station and directly pumped into a receptacle 
that forms an integral part of a vehicle and from where the substance or mixture is normally 
not intended to be removed, the label elements referred to in Article 17 shall be provided on 
the respective pump.’; 

ANNEX III 

Annex VIII to Regulation (EC) No 1272/2008 is amended as follows:  

(1) Part A is amended as follows:  

(a)  Section 1 is replaced by the following: 

‘1. Application 

1.1 Importers, downstream users and distributors referred to in Article 45(1c) placing on the 
market mixtures for consumer use, within the meaning of Section 2.4 of Part A of this Annex, 
shall comply with this Annex from 1 January 2021.  

1.2. Importers, downstream users and distributors referred to in Article 45(1c) placing on the 
market  mixtures  for  professional  use,  within  the  meaning  of  Section  2.4  of  Part  A  of  this 
Annex, shall comply with this Annex from 1 January 2021.  

1.3. Importers, downstream users and distributors referred to in Article 45(1c) placing on the 
market  mixtures  for  industrial  use  or  mixtures  with  an  end  use  not  subject  to  notification 
within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 
1 January 2024.  

1.4.  Importers,  downstream  users  and  distributors  referred  to  in  Article  45(1c)  having 
submitted information relating to hazardous mixtures to a body appointed in accordance with 
Article  45(1)  before  the  dates  of  applicability  mentioned  in  Sections  1.1,  1.2  and  1.3  and 
which  are  not  in  accordance  with  this  Annex,  shall  for  those  mixtures  not  be  required  to 
comply with this Annex until 1 January 2025.  

1.5. By way of derogation from Section 1.4, if one of the changes described in Section 4.1 of 
Part  B  of  this  Annex  occurs  before  1  January  2025,  importers,  downstream  users  and 
distributors  referred  to  in  Article  45(1c)  shall  comply  with  this  Annex  before  placing  that 
mixture, as changed, on the market.’; 

(b)  Section 2.1 is replaced by the following: 

‘2.1  This  Annex  sets  out  the  requirements  that  importers,  downstream  users  and 
distributors  referred  to  in  Article  45(1c)  (‘submitters’)  placing  mixtures  on  the 
market  shall  fulfil  in  respect  of  the  submission  of  information  so  that  appointed 
bodies have at their disposal the information required to carry out the tasks for which 
they are responsible under Article 45.’;  

EN 

47 

  EN 

 
 
(c) in Section 2.4., first subparagraph, the following point (6) is added: 

‘composition conforming with a standard formula specified in Part D’ means a 
‘(6) 
composition which includes all the components listed in one of the standard formulas 
referred  to  in  Part  D  of  this  Annex,  where  those  components  are  present  in  the 
mixture in concentrations within the ranges specified in that standard formula.’;  

(2) Part B is amended as follows: 

(a) the following Section 1.1a. is inserted:  

‘1.1a. Name and product description of standard formula or name of fuel  

For  mixtures  with  a  composition  conforming  with  a  standard  formula  specified  in 
Part  D,  the  name  and  product  description  of  the  relevant  standard  formula  as 
indicated in that Part shall be included in the submission.  

For fuels listed in Table 3, the name of the fuel shall be provided as indicated in that 
table.’; 

(b) in Section 3.1, the third paragraph is replaced by the following:  

‘Components  which  are  not  present  in  a  mixture  shall  not  be  notified.  However,  if 
the  components  are  notified  as  part  of  an  interchangeable  component  group  in 
accordance with Section 3.5. or their concentration has been submitted as a range of 
percentages  in  accordance  with  Sections  3.6.  or  3.7,  they  may  be  notified  if  it  is 
certain that they will be present in the mixture at some point in time. In addition, for 
mixtures with a composition conforming with a standard formula specified in Part D 
for  which  the  composition  is  notified  in  accordance  with  Section  3.6,  first  indent, 
components  listed  in  the  relevant  standard  formula  shall  be  notified  even  if  the 
component  is  potentially  not,  or  not  permanently,  present  in  cases  where  the 
indicated concentration range in Part D includes 0 %.’; 

(c) the title of Section 3.6. is replaced by the following:  

‘3.6.  Mixtures with a composition conforming with a standard formula’; 

 (d) in  Section 3.7., the first row of Table 3 is replaced by the following:   

‘Fuel name 

Product description’; 

(e) in Section 4.1, the first paragraph, the following indent is added; : 

‘- when there are other changes to a mixture placed on the market which are relevant 
for the emergency health response referred to in Article 45’; 

(3) Part C is amended as follows: 

(a) Section 1.2. is replaced by the following:  

‘1.2 Identification of the mixture, submitter and contact point 

Product identifier 

–  Complete trade name(s) of the product including, where relevant, brand name(s), 
name  of  the  product  and  variant  names  as  they  appear  on  the  label,  without 

EN 

48 

  EN 

 
 
abbreviations or non-alphanumerical symbols and enabling specific identification 
of the product.  

–  Unique Formula Identifier(s) (UFI) 

–  Other identifiers (authorisation number, company product codes) 

–  In case of group submission, all product identifiers shall be listed. 

Name and product description of standard formula or name of fuel  

–  Standard  formula  name  and  product  description  as  specified  in  Part  D  (where 

applicable) 

–  Fuel name as specified in Table 3 of Part B (where applicable) 

Contact details of the submitter and contact point 

–  Name 

–  Full address  

–  Telephone number 

–  E-mail address 

Contact details for rapid access to additional product information (24 hours/7 days). 
Only for limited submission. 

–  Name 

–  Telephone number (accessible 24 hours per day, 7 days per week) 

–  E-mail address’; 

(b) Section 1.4. is replaced by the following:  

‘1.4. Information on the mixture components and interchangeable 

component groups 

Identification of the mixture components 

— Chemical/trade name of the components 

— CAS number (where applicable) 

— EC number (where applicable) 

— UFI (where applicable)  

— Standard formula name and product description (where applicable) 

– 

Fuel name (where applicable)’; 

Name of interchangeable component groups (where applicable) 

Concentration and concentration ranges of the mixture components 

— Exact concentration or concentration range 

Classification of mixture components 

— Hazard classification (where applicable) 

EN 

49 

  EN 

 
 
— Additional identifiers (where applicable and relevant for health 

response) 

List according to Part B, Section 3.1, fifth subparagraph (where applicable) ’; 

(4) Part D is amended as follows: 

(a) 

In section 1, the first row of the tables with standard formulas for cement are 
replaced by the following:  

‘Standard formula name   

Cement Standard Formula 1’ 

‘Standard formula name 

Cement Standard Formula 2’ 

‘Standard formula name 

Cement Standard Formula 3’ 

‘Standard formula name 

Cement Standard Formula 4’ 

‘Standard formula name 

Cement Standard Formula 5’ 

‘Standard formula name 

Cement Standard Formula 6’ 

‘Standard formula name 

Cement Standard Formula 7’ 

‘Standard formula name 

Cement Standard Formula 8’ 

‘Standard formula name 

Cement Standard Formula 9’ 

‘Standard formula name 

Cement Standard Formula 10’ 

‘Standard formula name 

Cement Standard Formula 11’ 

EN 

50 

  EN 

 
 
 
 
 
 
 
 
 
 
 
‘Standard formula name 

Cement Standard Formula 12’; 

‘Standard formula name 

Cement Standard Formula 13’ 

‘Standard formula name 

Cement Standard Formula 14’ 

‘Standard formula name 

Cement Standard Formula 15’ 

‘Standard formula name 

Cement Standard Formula 16’ 

‘Standard formula name 

Cement Standard Formula 17’ 

‘Standard formula name 

Cement Standard Formula 18’ 

‘Standard formula name 

Cement Standard Formula 19’ 

‘Standard formula name 

Cement Standard Formula 20’; 

(b) 

In section 2, the two first rows of the table with standard formula for gypsum is 
replaced by the following: 

‘Standard formula name 

–  Gypsum binder Standard Formula 

Product description 

Gypsum binder’; 

(c) 

In section 3, the two first rows of the tables with standard formulas for ready 
mixed concrete are replaced by the following: 

‘Standard formula name 

–  Ready mixed concrete Standard Formula 1  

Product description 

–  Ready mixed concrete with concrete strength 

classes C8/10, C12/15, C16/20, C20/25, 

EN 

51 

  EN 

 
 
 
 
 
 
 
 
 
 
 
C25/30, C28/35, C32/40, C35/45, C40/50, 
C45/55, C50/60, LC8/9, LC12/13, LC16/18, 
LC20/22, LC25/28, LC30/33, LC35/38, 
LC40/44, LC45/50, LC50/55, LC55/60’; 

‘Standard formula name 

–  Ready mixed concrete Standard Formula 2 

Product description 

–  Ready mixed concrete with concrete strength 

classes C55/67, C60/75, C70/85, C80/95, 
C90/105, C100/105, LC 60/66, LC70/77, 
LC80/88’. 

1. 

2. 

3. 

Article 2 

This  Regulation  shall  enter  into  force  on  the  twentieth  day  following  that  of  its 
publication in the Official Journal of the European Union. 

The following provisions shall apply from [OP: please insert the date = the first day 
of  the  month  following  18  months  after  the  date  of  entry  into  force  of  this 
Regulation]:  

(a)  Article 1, points (1), (4), (5), (6), (7), (10), (11), (12), (15), (16), (20), (21), (23) 

and (24); 

(b)  points (2), (3), (7), (9) and (10) of Annex I; 

(c)  Annex II; 

(d)  points (1)(c), (2), (3) and (4) of Annex III.    

By way of derogation from Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), 
Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and 
(2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 
1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, 
the  first  sub-paragraph  of  section  2.4,  of  Annex  VIII,  Part  B,  section  1,  of  Annex 
VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of 
Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the 
first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex 
VIII,  and  Part  D,  sections  1,  2  and  3,  of  Annex  VIII  to  Regulation  (EC)  No 
1272/2008 as applicable on [OP: please insert the date = the day before the date of 
entry  into  force  of  this  Regulation],  substances  and  mixtures  may  until  …  [OP: 
please insert the date = the last day of the month following 17 months after the date 
of  entry  into  force  of  this  Regulation]  be  classified,  labelled  and  packaged  in 
accordance  with  Regulation  (EC)  No  1272/2008  as  amended  by  the  following 
provisions of this Regulation: 

(a)  Article 1, points (1), (4), (5), (6), (7), (10), (11), (12), (16), (20), (21) and (23); 

(b)  points (2), (3), (7) and (9) of Annex I; 

(c)  Annex II; 

(d)  points (1)(c), (2), (3) and (4) of Annex III.    

EN 

52 

  EN 

 
 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

53 

  EN