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}   EN 1  EN 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 Chemic als 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 Eur opean 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 p rotection 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 go od 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’ abilit y 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 (‘ invent ory), 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 exposur e 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 The European Green Deal, Communication from the Commission, Brussels, 11.12.2019 , p. 15 
(COM(2019) 640 final ). 
2 European Commiss ion, Revision of EU legislation on hazard classification, labelling  and packaging of 
chemicals . 
3 Chemicals Strategy for Sustainability, Communication from the Commission, Brussels, 14.10.2020 
(COM(2020) 667 final ). 
4 Council Conclusions on Sustainable Chemicals Strategy of the Union , 2021.  
5 European Parliament, Resolution of 10 July 2020 on the Chemicals Strategy for Sustainability , 2020 
(2020/2531(RSP)).  
6 https://www.un.org/ga/search/view_doc.asp?symbol=A/RES/70/1&Lang=E .  
7 https://sdgs.un.org/goals .  
8 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 . 
9 Amec Foster Wheel er et al., A Study to gather insights on the drivers, barriers, costs and benefits for 
updating REACH registration and CLP notification dossiers , 2017.  EN 2  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 be en 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, chem icals 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 substance s or mixture s, 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 inf ormed 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 Commission Staff Working Document – Impact Assessment Report Accompanying the document 
Proposal for a Regulation of the European  Parliament and of the Council a mending Regulation (EC) 
1272/2008 of the Eu ropean Parliament and of the Council on classification, labelling and packaging  of 
substances and of mixtures (‘Impact Assessment Report’), (not yet published) , p. 34.  
11 2017 Special Eurobarometer 468 .  
12 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.  
13 KEMI, Increased e -commerce – increased chemicals risks? A mapping of the challenges of e -commerce 
and proposed measures. Report of a government assig nment , 2021.  EN 3  EN Another provision leading t o 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 
mixtu res 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 fo r 
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 enforcem ent.  
The CLP Regulation revision package therefore aims to:  
(i) ensure that all hazardous chemicals, including those with ED, PBT, vPvB, 
PMT and vPvM properties, are classified adequately and uniformly throughout 
the EU;  
(ii) improve the efficiency of haz ard 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 pro posal 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 Di rective 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 4  EN Under the CLP Regulation, the decision to classify a substance or a mixture for environ mental 
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 r egulations  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 unde r 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 o ther 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 Whereby placing on the EU market is conditional upon  receiving authorisation to do so.  
16 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).  
17 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). 
18 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 . 
19 Chemicals Strategy for Sustainability, Communication from the Commission, Brussels, 14.10.2020 , p. 
9 and 16, (COM(2020) 667 final).  EN 5  EN substances and mixtures alread y 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 iden tifying 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 t he 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 sig nificant 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 th e 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. Bot h 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 fo r 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 Regulat ion. 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 Impact Assessment Report , p. 46; Annex  to the Impact Assessment Report,  p. 147. 
21 Impact Assessment Report; Executive Summary of the Impact Assessment Report  EN 6  EN 3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
• 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 som e 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 i mpact 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 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 . 
23 European Commission, Revision of EU legislation on hazard classification, labelling and packaging of 
chemicals, av ailable 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 . 
24 European Commission, Revision of EU legislation on hazard classification, labelling and packaging of 
chemicals, av ailable 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 7  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 discu ssions 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 centr es 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 betwee n 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 stakeh older 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 c onsultation 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 Commi ssion 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 fo r 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 8  EN notification. 72% of respondents to the open public consultation believe that the obligation to 
agree on a n 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 diffe rent 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 repeate dly 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 particu lar 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 associatio ns 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 pro duct 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 lik ely 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 ambiguo us 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 9  EN rules for the ob ligation 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 a ssessment 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 
potent ial 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. Inclusion of new hazard classes;  
1.2. Consistent classification and im proving transparency ; 
1.3. More and prioritised harmonised classification;  
1.4. Complementing hazard identification with hazard quantification.  
Three options were analysed with regards to the second problem on the communication of 
chemicals hazards:  
1.5. New or revised guidance;  
1.6. Improving labelling and packaging and making labelling more flexible;  
1.7. Digital labelling.  
Finally, three option s were developed in response to the third problem on addressing  main 
legal gaps and ambiguities:  
1.8. Awareness  campaigns;  
                                                 
26 ECHA, REF-6 project report - Classification and labelling of mixtures,  2019; ECHA REF-8 project 
report on enforcement of CLP, REACH and BPR du ties related to substances, mixtures and articles sold 
online , 2021.   
27 Opinion of the Regulatory Scrutiny Board, May 11 2022 (Ref. Ares(2022)3650615 – 13/05/22).  EN 10  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, b iodiversity 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 hea lth 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  
1. COMPREHENSIVE IDENTIF ICATION AND CLASSIFI CATION OF CHEMICAL H AZARDS  
The first set o f 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 meas ure, 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 11  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 m aking 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, manufacture rs, 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 COMMUNICATIO N  
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 m ethod 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 ad dition, 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 labellin g 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 expen sive or even impossible in practice.  EN 12  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 req uirements.  
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 chemicals on the market 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.  
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 s ave 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 pro ducts 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 pa rticular 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 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 .  
29 OJ L 304 , 22.11.2011, p. 64 .  EN 13  EN Prioritisation of the harmonised classification and labelling of sub stances 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 underg o 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 
require ments , 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 bette r 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 a nd 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 haza rd 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 inclusively, based on full transparency and continuous engagement with 
stakeholders, listening to external feedback and  taking account of external scrutiny to ensure 
the proposal strikes the right balance.  
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 b enefit to 
SMEs . On hazard communication, broader use of fold -out labels (estimated savings of up to EN 14  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 co sts 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 c osts. 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 ma rket.  
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 c oherent, 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 cl assifications 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, limitat ions 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 
accordan ce 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 protectio n 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 15  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 Article s 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. Moreo ver, 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 environm ent 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 t ake 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 conclusio ns of June  2019, the Council also called for 
                                                 
31 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.    
32 Proposal for new work on unaddressed hazard classes in the programme of work for the biennium 
2023 -2024 (European Union) |UNECE  
33 European Parliament resolution of 18 April 2019 on a comprehensive European Union framework on 
endocrine disruptors (2019/2683(RSP)) (P8_TA(2019)0441) . EN 16  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 Sustain ability ‘without undue delay’.  
• Implementation plans and monitoring, evaluation and reporting arrangements  
To monitor and evaluat e the effectiveness of this proposal, the Commission is currently 
developing  a framework – due by 2024 – of indicators monitor ing the drivers and impacts of 
chemical pollution and measur ing 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. Th is 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, 
whic h 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) specif ies that the supplier in the EU  which ensures that the substance or the 
mixture in questio n 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 s ubstances ’ shall, normally, be classified 
following the same classification, labellin g, and packaging rules as mixtures and includes the 
identification and examination of available information on these ‘multi-constituent 
substances’.  
Article 6(3) and Article 6(4) are amended to extend to the new hazard classes regarding 
endocrine disruptor s, 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 ‘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   
35 //data.consilium.europa.eu/doc/document/ST -10713 -2019 -INIT/en/pdf, p.3  
36 ‘Sustainable Chemicals Strategy of the Union: Time to Del iver-Council conclusions’, 15 March 2021, 
https://www.consilium.europa.eu/media/48827/st06941 -en21.pdf  
 EN 17  EN Amendments to Article 9(3) and (4) cla rify 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 r equire manufacturers, importers and downstre am 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 subs tances 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 concentrati on 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 clas sified 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 timefram e 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 t o 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, impor ters and downstream users. In such a EN 18  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 refe rences to ‘substance’ by ‘substances’ . It is clarified that 
the harmonised classification and labelling procedure under Article 37 can include acute 
toxicity estimates where appropriate.  Paragraph s 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 ame ndment 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 classi fication 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 Ag ency 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  
offer s linked to the marketing and sale of hazardou s 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 requir ement for distance sales offer s 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 tool s 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 indu stry 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 19  EN The amendment to Article 53c relates to the scope of the Commiss ion’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 provisi on 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 requirement s 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 20  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 t he 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 co mpliance 
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. I n accordance with Article 13 of Regulation (EC) No 1907/2006  of the 
                                                 
1 OJ C , , p. .  
2 Position of the European Parliament of xxx and decision of the Council of xxx.  EN 21  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 . 
(3) 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 individu al 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 o n those m ulti-constituent  substance s 
themselves may also be relevant. This is the case in particular where that data 
demonstrate s endocrine disrupting properties for human health and the environment, 
as well as persistent, bioaccumulative and mobile proper ties, or where it support s data 
on the individual constituents.  Therefore, it is appropriate that data on m ulti-
constituent substances are used in those cases . 
(4) 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 . Suc h 
clarification should ensure  that the weight of evidence determination complement s 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, manufac turers, 
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.  
(5) 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 whi ch 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.  
(6) 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 f our 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 
                                                 
3 Regulation (EC) No 1907/2006  of the European Par liament 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 22  EN (inhalation) values or as acute toxicity est imates. It is appropriate to specify the 
meaning of, and further specif y, acute toxicity estimates to increase their clarity and 
consistency. As acute toxicity estimates are part of the harmonised classification and 
labelling elements of substances classif ied 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 ju stification, be notified to the Agency in view of 
their inclusion in the classification and labelling inventory.  
(7) Ammunition qualifying as a substance or a mixture is to bear a label affixed to the 
surface of the packaging immediately containing the su bstance 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 a n exemption from the labelling re quirements and allow  for alternative ways of 
communicating the hazard information.   
(8) In order to enhance clarity,  all supplemental labelling requirements should be placed 
together in one Article.  
(9) Part 2 of Annex II to Regulation (EC) No 1272/2008 s ets 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, th ey should be applied to all mixtures re ferred to in Part 2 of Annex II, 
regardless of whether they are classified and whether they contain any classified 
substance.  
(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 
trigger ing 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, E valuation, Authorisation and Restriction of 
Chemicals (REACH) (OJ L 331, 12.10.2020, p.24.)  EN 23  EN classification and labelling, the deadlines to update the labelling information should be 
set at the date of applica tion 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 delegate d 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 f ont 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 haz ard 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 labell ing. 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) 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 b e 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.  
(14) In order to adjust to technological changes and developments in the field of 
digitalisation, the Commission should be empowered to adopt delegate d 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 
product s, 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 a nd 
categories prohibiting such refill station sales for substances of mixtures meeting the 
criteria for classification in those hazard class es 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 24  EN of citizens, it is appropriat e 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.   
(17) As the new hazard classes and criteria introdu ced 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 includes respiratory sensitisation, germ cell mutagenicity, 
carcinogenicity and reproductive toxicity. Sub -categorisation of the hazard class for 
respirato ry 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 p roposals  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, wh ile 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 clas sification 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 autho rities. 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 s ubstances and mixtures , OJ XX of XX p 
XX.] EN 25  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 Com mission 
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 crit eria 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 include d 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 include d 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 differe nt 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 case s, the  divergences are due to 
differences in data used for classification , or to dis agreement 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. A s 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 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). 
 
7 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 Direc tives 
79/117/EEC and 91/414/EEC ( OJ L 309, 24.11.2009, p. 1 ). EN 26  EN classifications, ultimately hindering the ability of Re gulation (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 . 
(25) 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, th at 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 submitt ed 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 bord ers 
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 d istributors , where they further distribute 
hazardous mixtures in other Member States or where they rebrand or relabel hazardou s 
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 Cent res 
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 useful ly 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 27  EN (29) Regulation (EC) No 1272/2008 regulates advertisement of hazardous substances and 
mixtures in a general manner  and pr ovides 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 th e 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 shou ld 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 a dvertisements 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 no t against remuneration, offers a re 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 t o 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 techni cal 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, t he 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 p rogress. According to Article 53c of 
                                                 
8 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).  
9 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).  
10 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 28  EN 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) N o 1272/2008 that are subject to 
different empowerment s. 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 adoptio n 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.  
(33) In accordance with Directive 2010/63/EU  of the European Parliament and of the 
Council11, it i s necessary to replace, reduce or refine 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, whereve r 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 mo nitored 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 rece ived 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 informa tion 
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 descripti on 
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 certa inty 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 sho uld 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 o f 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 29  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 th e 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 ca n 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:  
Article 1  
Regulation (EC) No 1272/2008 is amended as follows:  
(1) in Article 1(1), the following point (f) is added:  
‘(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 b odies in accordance with Annex VIII.’;  
(2) in Article 2, the following point s 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 substa nce 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 followin g 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 disrup ting 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 30  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 s ubstance itself shall be 
taken into account where one of the following conditions are met:   
(a) the information demonstrates germ cell mutage nic, 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 s ubstance 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 bi oaccumulative’, ‘persistent, mobile and toxic’ and ‘very 
persistent and very mobile’ hazard class es 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 t he 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 conditio ns are met: 
(a) the information demonstrates biodegradation, persistence, mobility and 
bioaccumulation properties.  
(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 . 
(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 pro perty 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, w here the available test data on the mixture itself demonstrate s 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 31  EN ‘hazardous to the aquatic environm ent’, ‘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 rep laced 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 determin ation 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 Anne x 
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 i n 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.  
Whe n evaluati ng 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 subparagraph s, evaluate 
the information by applying the other method or methods set out in Parts 3 and 4 of 
Annex I.’;  
(7) Article 10 is replace d 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 thr eshold 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 P art 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 32  EN In exceptional circumstances specific concentration limits may be set by the 
manufacturer, importer or downstream user where that manufactur er, 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 manuf acturers, 
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. By way of derogation from paragraph 1, specific conc entration 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. 
5. 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.  
6. By way  of derogation from paragraph 3 , acute toxicity estimates shall not be 
established for harm onised 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, import ers 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 P art 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 concentratio n 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 pa ragraphs 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 33  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 consti tuent 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 t he 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 packagin g 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 Pa rt 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 paragraph s 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 saf ety data sheet or a leaflet containing the 
information referred to in Article 17(1) .’; 
(12) Article 30 is replaced by the following : EN 34  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 sh all 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 th at 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 classif ication 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 Articl e 53(1). In 
such case s, 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 th ose 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 o ut clearly from the background and they shall be of such 
size and spacing as to be easily read. The y shall be formatted in accordance with 
section 1.2.1 of Annex I.’;  
(14) in Article 32, paragraph 6 is deleted ;  
(15) in Title III, the following Chapter 3 is added:  
‘CHAPTER 3  
Formats of the  label ling 
 
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 35  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) the information on the digital label shall be accessible to all users in the U nion,  
(d) the digital label shall be accessible free of charge, without the need to register, 
download or install appli cations, or to provide a password;  
(e) 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;  
(f) the information on the digital label shall be accessible with no more than two 
clicks;  
(g) 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) 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;  
(j) 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 p urchase  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 t rack, 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 
Title s 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 36  EN (b) the following points  (e) to (j)  are added:  
‘(e) endocrine disrupt ion for human health, category 1 or 2 (Annex I, section 
3.11.); 
(f) endocrine disrupti on 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 bioaccumu lative (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) shal l 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 th e Agency.  
The proposal s 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 Europea n 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 parag raph 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 37  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 number s 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 replac ed 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 Commissio n in 
accordance with the procedure referred to in Article 54(2).’ ; 
(e) paragraph s 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 su bstances 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 V I. 
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 inclus ion 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 clas sification 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 38  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:  
(a) endocrine disruptor in accordance with Section 3.6.5 or Section 3.8.2 of 
Annex II to Regulation (EC) No 1107/2009;  
(b) persistent, bioaccumulative and toxic or very persistent and very 
bioaccumulative in accordance with Section 3.7.2. or 3.7.3. of Annex II to 
Regulation (EC) No 1107/2009;  
(c)  endocrine disruptor for human health or for the environment in 
accordance with Article 1  of Commission Delegated Regulation (EU) 
2017/2100*;  
(d)  persistent, bioaccumulative and toxic or very persistent and very 
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 -factor s 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 39  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 th e 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 no tifier 
duly justifies why such publication is potentially harmful for its 
commercial interests or the commercial interests of any other concerned 
party ;  
(b) i n the case of group notifications, the identity of the importer or 
manufacturer submitting the in formation 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 bod ies appointed in accordance with paragraph 1 the 
harmonised informatio n 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 referr ed 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 40  EN demonstrate that the appointed body or bodies already r eceived 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 impr oved 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 1 c, 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 th e 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 Artic le 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 popu lation groups  in the Union . When  adopting those delegated acts, the EN 41  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 ) devel opments 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 label ling 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 th ose 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 
on choices of technology or equipment, within the bounds of 
compatibility and interference avoidance;  
(d) take into account the level of digital readi ness 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 for the environm ent, 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.’;  
(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 amend ed as follows:  
(a) in paragraph 2 , the first sentence  is replaced by the following:  
‘The power to adopt delegated acts referred to in Article s 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  Article s 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 42  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 tha t 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, s ection 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 A nnex 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 Anne x 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 entr y 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) Annex I is amended as set out in Annex I to this Regulation;  
(32) Annex II is amended as set out in Annex II to this Regulation;  
(33) Annex VIII is amended as set out in Annex III to this Regulation.  EN 43  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 consid ered. 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 cla ssified 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.  The dimensions of the label and of each pictogram, and the font size of 
letters shall be as follows:  
Table 1.3  
Minimum dimensions of labels, pictograms and font size  
Capacity of the 
package  Dimensions of the label 
(in millimetres) for the 
information required by 
Article  17 Dimensions of each 
pictogram (in 
millimetres)  Minimum font -size 
Not exceeding 3 
litres:  If possible, at least 
52x74  Not smaller than 
10x10  
If pos sible, at least 
16x16  8pt 
Greater than 3 
litres but not 
exceeding 50 
litres:  At least 74x105  At least 23x23  12pt 
Greater than 50 
litres but not 
exceeding 500 
litres:  At least 105x148  At least 32x32  16pt 
Greater than 500 
litres:  At least 148x210  At least 46x46  20pt’;  EN 44  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) the background of the label shall be white;  
(b) the distance between two lines shall be equal or above 120  % of the font 
size; 
(c) a single font shall be used that is easily legible and without serifs ;  
(d) 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 excee d 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 requirement s 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 Sectio n 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 pr ovided 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 t he 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 45  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 a nd 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 informa tion 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(2 a), 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 plac e of the refill station and with a 
font size that is easily legible and without serifs ; EN 46  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 whe re 
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 meet s 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, 1 B 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 disrupt or for human health, categories 1 and 2].’;  
(xiv) [insert: Endocrine disrupt or 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 derogat ion 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 47  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, downst ream  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 an d 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 20 24.  
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 o f 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 the ir disposal the information required to carry out the tasks for which 
they are responsible under Article 45.’;  EN 48  EN (c) in Section 2.4. , first subparagraph, the following point (6) is added:  
‘(6) ‘composition conforming with a standard formula specified in Par t D’ means a 
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 i nterchangeable 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 so me point in time. In addition, f or 
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 sha ll 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 49  EN abbreviations or non -alphanumerical symbols and enabling specific id entification  
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 c ontact 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 a ddress’ ; 
(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 50  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 formula s 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 51  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 sec tion 2, the two first row s 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 f irst row s of the tables with standard formulas for r eady 
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 52  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 wit h concrete strength 
classes C55/67, C60/75, C70/85, C80/95, 
C90/105, C100/105, LC 60/66, LC70/77, 
LC80/88 ’. 
 
Article 2  
1. This Regulation shall enter into force on the twentieth  day following that of its 
publication in the Official Journal of the European  Union.  
2. The following provisions shall apply from  [OP: please insert the date = t he 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.    
3. 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 firs t 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 for ce 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 Regulatio n (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 53  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President