EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the  
classification, labelling and packaging of substances and mixtures  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
The objectives of Regulation (EC) No 1272/2008 on classification, labelling and packaging of 
substances and mixtures (CLP  Regulation ) are to ensure (i) a high level of protection of 
human health and the environment , and (ii) the free movement of substances, mixtures and 
certain articles . These objectives are fulfilled, inter alia , by establishing hazard classes and 
their criteria for classification of substances and mixtures at EU level. Article 53(1) of 
Regulation (EC) No 1272/2008 empowers the Commission to adjust and adapt Articles 6(5), 
11(3), 12, 14, 18(3)(b), 23, 25 -29 and 35(2) second and third subparagraph and Annexes I to 
VIII so as to bring them into line with  technical and scientific progress.  
The need to insert new hazard classes and their criteria into the CLP Regulation for its 
adaptation to technical and scientific progre ss has been recognised by its inclusion as one of 
the primary commitments  under the chemicals strategy for sustainability , which is a building 
block  of the European Green Deal, for the protection of consumers, vulnerable groups and 
workers from the most ha rmful chemicals and for the target of zero chemical pollution in the 
environment.  
Experience  and scientific knowledge gained  in the identification of substances under 
Regulation (EC) No 1907/2006 as substances of very high concern due to their endocrine 
disrupting properties highlight  the need to introduce new hazard classes in Regulation (EC) No 
1272/2008 to ensure a high leve l of protection for human health and the environment. Similar 
experience in the identification of substances with persistent, bioaccumulative and toxic 
properties (PBT) and very persistent, very bioaccumulative properties (vPvB) under 
Annex  XIII to Regulat ion (EC) No 1907/2006 has triggered the same need to introduce new 
hazard classes. Substances having probable serious effects on the environment due to their 
persistent, mobile and toxic (PMT) and very persistent, very mobile (vPvM) properties also 
requir e the introduction of the respective hazard classes. Based on deliberations and 
consultations of scientific experts, the criteria and accompanying hazard statements as laid 
down in the Annexes to this delegated regulation appropriately reflect the developme nt of 
scientific knowledge in these fields.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
2.1. Consultations of relevant expert group and ad  hoc discussions in its sub group  
Pursuant to Article 53a(4) of Regulation (EC) No 1272/2008 , experts designated by each 
Member State were consulted in the relevant expert group ‘Competent Authorities for 
Registration, Evaluation,  Authorisation  and restriction of C hemicals (REACH) and 
Classification, Labelling and Packaging (CLP) ( CARACAL )’ accord ing to the rules of the 
Interinstitutional  Agreement on Better Law -Making of 13 April  20161. In accordance with 
points 10 and 11 of the Annex to that Agreement, the European Parliament and the Council 
have received all documents related to those discussions and could send experts to the 
meetings of the  CARACAL expert group.  
                                                 
 
1 OJ L 123, 12.5.2016, p. 1.    
EN 2  EN  
Stakeholders were consulted in the CARACAL expert group in accordance with point 6 of the 
Annex to that Agreement. The progress and upd ates on the definition and criteria for new 
hazard classes were presented and discussed at the following  ad hoc CARACAL meetings: 
CARACAL meeting of 30  September  2021  on PMT, vPvM and PBT, vPvB substances , and 
CARACAL meeting of 14  December 2021 on New Haz ard Classes, More than One 
Constituent Substances (MOCS) and Self -classification.   
 
Scientific c riteria included in the Annexes to this Regulation follow, in addition, discussions 
in meetings of CARACAL’s Subgroup on Endocrine Disruptors held on 2  July 2020, 
7 February  2020, 19  October  2020, 22  March  2021, 13  September  2021 and 
24 February  2022 , and meetings  of ECHA’s PBT Expert Group  held on 28 May 2021 and 28 
June 2021 . At all these meetings , stakeholder representatives were present.   
 
The final consultations  of the  CARACAL expert group on this draft Delegated Regulation 
were held  on [placeholder]  2022 and [placeholder]  2022.  
2.2. Consultations during the impact assessment process  
In accordance with point 13 of the Interinstitutional Agreement o n Better Law -Making of 13  
April  2016 , the Commission carried out an impact assessment for review of  the CLP 
Regulation  composed of the legislative proposal and this delegated regulation . This impact 
assessment  includ es an analysis of impacts of  insertin g new hazard classification criteria 
given the significant economic, environmental and social impacts.  
 
The Commission’s Regulatory Scrutiny Board conducted  a quality check of the impact 
assessment , evaluating it positively with some reservations to be addressed in the final version 
of the impact assessment.  
 
As part of  the impact assessment process concerning the revision of the CLP Regulation, t he 
Commission held (a) an  open public consultation and (b) a targeted stakeholder survey  on 
a number of issues. Feedback on the new hazard classes was received as part of those 
consultation tools.   
a) Open public consultation  
The Commission launched the open public consultation on the revision of the CLP Regulation 
(Regulation (EC) No 1272/20 08 on the classification, labelling, and packaging of substances 
and mixtures) on 9 August 2021 for a period of 14 weeks ending on 15 November 20212. 
 
The Commission received 625 responses from four types of stakeholders: companies and 
business associations; EU and non -EU citizens; public authorities; and civil society (all other 
stakeholders) . Responses were mainly received from companies and business associations 
(45%) and from EU and non -EU citizens (39%) and civil society (12%). Of the respon ses 
from businesses, almost 69% were from SMEs , while 30% were from large companies. A 
                                                 
 
2 https://ec.europa.eu/info/law/better -regulation/have -your-say/initiati ves/12975 -Revision -of-EU-
legislation -on-hazard -classification -labelling -and-packaging -of-chemicals_en   
EN 3  EN total of 144 position papers were  uploaded. In terms of geographical distribution, most 
responses were received from France (28%) and Germany (20%).  
 
The results show th at opinions on the introduction of new hazard classes varied significantly 
betwe en different stakeholder groups.  
 
All stakeholders agreed that it was either ‘important’ or ‘very important’ for them to know if a 
chemical is either ‘an endocrine disruptor with adverse effects on human health’, ‘an 
endocrine disruptor with adverse effects on the environment’, ‘Persistent,  bio-accumulative 
and toxic’ and ‘Persistent, mobile and toxic’. Business associations and companies were the 
least likely to rate the need for knowledge of adverse effects as ‘very important’, but they still 
on average rated these aspects as ‘important’.  65% of respondents stated that they would be 
ready to pay 10 -50% more for alternative products not containing such chemicals.   
 
Civil societ y, public authorities and citizens were in favour of ‘a sub -categorisation for 
chemicals with a high level of certai nty on their endocrine -disrupting properties’, taking the 
view  that there should be a distinction between endocrine disruptors for human health and the 
environment, as well as a distinction between proven and suspected endocrine disruptors. 
63% of companie s and business associations were, however, not in favour of making a 
distinction between proven and suspected  endocrine disruptor s. 
 
The favoured label, chosen by 34% of respondents , for chemicals identified as toxic to 
reproduction and as an endocrine disruptor according to the planned criteria was: ‘ May cause 
infertility or damage to the unborn child;  May cause endocrine -related adverse effects on 
human health ’. 
72% of respondents a greed that criteria for PBT (Persistent, Bioaccumulative and Toxic) and 
vPvB (very Persistent and very Bioaccumulative) in Annex XIII of REACH should be 
introduced in the CLP Regulation. Most respondents (69% overall) did not believe that a 
category for su spected PBT (and one for suspected vPvB) was necessary . 
As regards PMT (Persistent, Mobile and Toxic) and vPvM (very Persistent and very Mobile) 
categories, the responses varied across the different stakeholder groups. While 75% of 
companies and business a ssociations did not consider  such categories  necessary, 79% of civil 
society, 62% of citizens and 53% of public authorities did.   
26% stated that the World Health Organi zation’s  definition and criteria for endocrine 
disruptors should be taken over word for word in the EU CLP criteria, while an equal 
percentage of 26% believed it was necessary to further refine the World Health 
Organi zation’s  definition and criteria and/or existin g criteria for plant protection and biocid al 
products  in order  to develop the CLP criteria.   
All stakeholder categories responded in the majority that environmental toxicity should be 
part of the toxicity criterion (74% of respondents overall), and 100% of  public authorities  
were of that view .  
Companies and business associations expressed repeated support that any of the new hazard 
classes referred to  above should only be introduced in Regulation (EC) No 1272/2008 as an 
implementation measure of the United  Nations Globally Harmonised System of Classification 
and Labelling of Chemicals (UN GHS).   
b) Targeted stakeholder consultation   
The targeted stakeholder consultation on CLP was open for 6 weeks from 10  November to 
22 December  2021. The purpose of the consultation was to gather expert advice from Member  
EN 4  EN States’ authorities and national CLP helpdesks , academia, NGOs, and duty holders. A total of 
167 responses and 39 position papers were received.   
Analysis of  the responses to the t argeted stakeholder consultation  show ed that support ers of 
the introduction of new hazard classes  believe d that the initiative would reduce exposure to 
hazardous chemicals  and lead to safer workplaces, to substitution by better and safer 
alternatives, and to better control of hazardous chemicals.   
However, the  analysis also show ed that business entities and associations were mostly not in 
favour  of introducing new hazard classes. Those stakeholders argued that such introduction 
would lead to potential information overload in hazard communication, distort the level 
playing field of international trade , and lead to cost increase s for various activities. Those 
stakeholders also expressed their  concerns about potential overlaps of the new hazard classes 
with existing ones for classification and labelling , together with  the concern that Regulation 
(EC) No 1272/2008 is not the proper means for addressing  endocrine disrupting properties , 
which refer to  a mode of action rather than a hazard. Counterar guments  put forward  
highlighted that in fact endocrine disruptors affect various organisms in very different ways; 
endocrine disruption should therefore be considered as  an intrinsic (hazardous) property  and 
hence qualifies as a hazard . 
Other commentators pointed to the fact that properties such as persistency and mobility are 
not necessarily related to hazards, i.e., they do not automatically mean that a chemical is 
hazardous. Some written responses from CARACAL members, however, highlig hted that the 
combination of specific properties, e.g., very persistent and very mobile or persistent, mobile 
and toxic , pose a threat to drinking water sources. Such combinations of properties increase 
the chances of chemicals passing through natural and artificial barriers in wastewater 
treatment facilities.   
2.3. Stakeholders’ feedback of the draft delegated act following publication on the 
‘Have Your Say’ portal (public feedback mechanism)  
[placeholder]  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal act amends Regulation (EC) No 1272/2008. The legal basis of this delegated act is 
Article   53(1) of Regulation (EC) No 1272/2008.  
This Regulation takes the form of a Commission Delegated Regulation. In light of the 
empowerment in Article 53(1) of Regulatio n (EC) No 1272/2008, it is appropriate to adapt 
Part 3 and Part 4 of its Annex  I, Part 1 of its Annex III , and Part 1 of its Annex VI to technical 
and scientific progress via delegated act, in accordance with Article 290 of the Treaty on the 
Functioning of  the European Union.   
EN 5  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the  
classification, labelling and packaging of substances and mixtures  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to 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 1907/20061, and in particular Article 53(1) thereof,  
Whereas:  
(1) Parts 2 to 5 of Annex I to Regulation (EC) No 1272/2008 contain harmonised criteria 
for the classification of substances, mixtures and certain articles in hazard classes and 
in differentiations  of those hazard classes  and set out provisions on how th ose criteria 
are to be met as well as the corresponding labelling requirements. Part 3 of Annex I to 
Regulation (EC) No 1272/2008 contains criteria on health hazards and Part 4 of that 
Annex contains criteria on environmental hazards.  
(2) The European Green Deal2 sets out the goal to better protect human health and the 
environment as part of an ambitious approach to tackle pollution from all sources and 
move towards a toxic -free environment.  
(3) The need to establish a legally binding hazard identification of endocrine disruptors, 
based on the definition established by  the World Health Organi zation in 20023 and 
building on criteria already developed for plant protection products4 and biocid al 
                                                 
 
1 OJ L 353, 31.12.2008, p. 1 . 
2 Communication from the Commission to the European Parliament, the European Council, the Council, 
the European Economic and  Social Committee and the Committee of the Regions – The European 
Green Deal (COM(2019) 640 final, 11 December 2019).  
3 WHO/IPCS (World Health  Organi zation /International  Programme  on Chemical Safety), 2002.  Global 
assessment on the state of the science of endocrine d isruptors (WHO/PCS/EDC/02.2 ), 
https://apps.who.int/iris/bitstream/handle/10665/67357/WHO_PCS_EDC_02.2.pdf .  
4 Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 
1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. OJ 
L 101, 20.4.2018, p. 33 –36.  
EN 6  EN product s5, and to apply it across all Union legislation , is highlighted in the 
Commission’s Communication ‘ Chemicals strategy for sustainability towards a toxic-
free environment’6. That Communication also points to the need to inclu de new hazard 
classes and criteria in Regulation (EC) No 1272/2008 in order to fully address 
environmental toxicity, persistency, mobility and bioaccumulation . 
(4) The Commission has conducted an impact assessment on the addition  of new hazard 
classes and criteria in Regulation (EC) No 1272/2008 , which encompassed an open 
public consultat ion, as well as a stakeholder consultation. The Commission has also 
consulted the European Chemicals Agency’s expert group on persistent, 
bioaccumulative and toxic chemicals , the competent authorities for REACH and CLP 
(CARACAL) , as well as the subgroup on  endocrine disruptors of that expert group , on 
the new hazard classes and criteria for classification and labelling of substances and 
mixtures, and has taken into account their scientific advice.  
(5) Based on e xperience and increased scientific knowledge gained in identifying 
substances as substances of very high concern due to their endocrine disrupting 
properties as well as in identifying substances as PBT (persistent, bioaccumulative, 
toxic) , vPvB  (very persi stent, very bioaccumulative) , PMT (persistent, mobile, toxic) 
and vPvM  (very persistent, very mobile) under Regulation (EC) No  1907/2006 of the 
European Parliament and of the Council7, it is necessary  to adapt Regulation (EC) 
No 1272/2008 to technical and scientific progress by introducing new hazard classes 
and criteria . The scientific criteria against which available evidence for classification 
in those hazard classes are to be assessed should reflect the current state of the science.  
(6) Substances and mixtu res with endocrine disrupting properties pose a concern to public  
health and the environment. It has been proven that endocrine disrupt ion can lead to 
certain disorders  in humans , among others  birth defects, developmental, reproductive 
or neurodevelopmental disorders, cancer, diabetes and obesity, and that those 
disorders  have a high and increasing incidence in both children and adults . It has also 
been  demonstrated  that endocrine disrupting properties can negatively affect animal 
populati ons.  
(7) Experience shows that substances and mixtures with PBT or vPvB properties  represent 
a very high concern. They do not easily break down in the environment and tend to 
accumulate in living organisms across the food web. Accumulation  of th ose 
substances in the environment is difficult to reverse, as the emission does not readily 
cease by  lowering their concentration, and the effects of this accumulation are often 
difficult to  predict in the long -term. Moreover, certain  PBT and vPvB substances 
                                                 
 
5 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, 17.11.2017, p. 1.  
6 Chemicals Strategy for Sustainability, COM(2020) 667 final.  
7 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 Coun cil 
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 7  EN which undergo long -range transport have the potential to contaminate remote pristine 
areas.  Once those substances are released into the environment, exposure to them is 
difficult to reverse , which  leads to cumulative exposure of both animals and humans 
via the e nvironment.  
(8) PMT and vPvM substances pose concerns as, due to their high persistence together 
with their low adsorption potential and mobility, they can enter the water cycle, 
including drinking water, and spread over long distances. Many PMT and vPvM 
subst ances are only partly removed by wastewater treatment processes and can even 
break through the most advanced purification processes at drinking water treatment 
facilities. Such  incomplete removal coupled with new emissions mean that the 
concentration  of th ose PMT and vPvM substance s in the environment increase over 
time. Once released into the environment, exposure  to PMT and vPvM substances  is 
difficult to reverse , which  leads to cumulative exposure of both animals and humans 
via the environment . Any effects from this exposure are unpredictable in the long -
term. 
(9) In light of the increased scientific knowledge and experience gained in identifying 
endocrine disruptors for human health and the environment as well as PBT, vPvB, 
PMT and vPvM substance s and mixtures, it is appropriate to introduce hazard classes 
for those substances and mixtures and the corresponding scientific criteria to identify 
them . 
(10) The level of evidence as regards endocrine disrupting properties may be of different 
scientific stren gth. It is therefore appropriate to create two categories of endocrine 
disruptors : known or presumed endocrine disrup tors (category  1) and suspected 
endocrine disruptors (category 2), both  for human health and for the environment.  
(11) When developing guidance on the application of the endocrine disruptor criteria, the 
European Chemicals Agency  can benefit from the experience gained from the 
implementation of legislation on plant protection products and biocidal products and 
other scient ific justifications , in order to provide guidelines that clarify which effects 
not lead ing to chronic outcomes for human health and the environment could fall 
outside the definition of ‘adverse effect’ . 
(12) The intrinsic properties of PBT and vPvB substances and mixtures display similarities , 
but they differ substantially  with regard to the toxicity criterion. It is therefore 
appropriate to create two separate hazard classes , each  with its own criteria, while 
establishing common rules for the scientific assessment of the intrinsic properties  
related to persistency and bioaccumulation .  
(13) The intrinsic properties of PMT and vPvM substances and mixtures display 
similarities, but they differ substantially with regard to the toxicity criterion. It is 
therefore appropriate to create two separate hazard classes, each with its own criteria, 
while establishing common rules for the scientific assessment of the intrinsic 
properties related to persistency and mobility.  
(14) In order to allow for adequate classification of s ubstances  and mixtures  as PBT and 
vPvB , whether or not registered under Regulation (EC) No 1907/2006 , the existing 
criteria for identification of PBT and vPvB substances set out in  Section  1 of 
Annex  XIII to Regulation (EC) No 1907/2006  should be included in Regulation (EC) 
No 1272/2008 . In this regard , any introduction of hazard categories for PBT and vPvB 
in Regulation  (EC) No 1272/2008 would  not be appropriate  in view of the  high level 
of scientific strength of the evidence required to fulfill the PBT an d vPvB criteria -  
EN 8  EN which mirror those so far laid down in Annex XIII to Regulation No 1907/2006 . 
Moreover, the screening  information laid down in  that Annex , to be considered when 
screening for P, vP, B, vB and T properties , serve s a different  purpose than hazard 
identification and classification. In addition, the development of criteria for further 
hazard categories based on th at screening information would lead to overclassification 
and significant overlaps with existing environmental classification. Therefore, it would  
not be appropriate to introduce additional hazard categories  for PBT and vPvB  in 
Regulation (EC) No 1272/2008 .  
(15) The classification criteria for M/vM  relate , in particular,  to the  log K oc (soil adsorption  
coefficient)  value . The K oc value  is the organic carbon -water partition coefficient  and 
reflects the ability of a substance  to be adsorbed  on the organic fraction of solid 
environmental compartments such as soil, sludge and sediment, and is ther efore 
inversely related to the substances’  potential o f enter ing into ground  water. It is 
therefore appropriate to assess the mobility criterion against the log K oc value of a 
substanc e, a low K oc implying a high mobility .  
(16) Providing for  new hazard classes entails introducing those classes with their name, 
their respective  hazard statements and their respective hazard category codes. It is 
therefore necessary to include th ose hazard class es, hazard statements  and category 
codes  in Annex es I, III and VI to Regulation (EC) No 1272/2008.   
(17) To ensure that suppliers of substances and mixtures have time to adapt to the new 
classification  and labelling provisions, the application of the obligation to classify  and 
label substances and mixtures in a ccordance with this Regulation should be 
deferred.  Substances and mixtures which are already placed on the market  before the 
end of that deferral period, should be allowed to  continue being placed on the market 
without being re-classified  and re-labelled i n accordance with this Regulation,  to avoid 
additional burden on suppliers of substances and mixtures .   
(18) In line with the transitional provisions set out in  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  and labelling 
provisions before the date of application of  the obligations to classify  and label 
substances and mixtures in accordance with  this Regulation.   
(19) Regulation (EC) No 1272/2008 should therefore be amended accordingly , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EC) No 1272/2008 is amended as follows : 
 
(1) Annex I is amended as set out in Annex I to this Regulation ; 
(2) Annex III is amended as set out in Annex II to this Regulation ;  
(3) Annex VI i s amended as set out in Annex III to this Regulation.  
 
Article 2  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
  
EN 9  EN  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels , 
 For the Commission  
 The President  
 Ursula VON DER LEYEN