EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft 
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending, for the purposes of its adaptation to technical and scientific progress, 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council on 
classification, labelling and packaging of substances and mixtures as regards the 
addition of n otes to Part 1, section 1.1.3.1, of Annex VI  
(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) are to ensure a high level of protection of human health and 
the environment as well as the free movement of substances, mixtures and  articles. These 
objectives are fulfilled, inter alia , by establishing a list of substances with their harmonised 
classifications and labelling elements at Union level. Subsection 1.1.3. of Part 1 of Annex VI  
of that Regulation  lists notes which may be assigned to one or more harmonised classification 
and labelling entr ies and relate to the identification, classification and labelling of substances 
as well as the classification and labelling of mixtures. The  purpose of the se notes is to provid e 
legal clarity and certainty in applying harmonised classification and labelling.  
It was recommended by the Committee for Risk Assessment ( RAC ) of the European 
Chemicals Agency (ECHA)  and requested by Member States  experts in the CARACAL 
expert group  to include  additional notes in subsection 1.1.3. of Part 1 of Annex VI of CLP  to 
address the appropriate classification of certain substances belonging to a group entry, and of 
certain mixtures that contain several substances belonging to a group of relate d substances. It 
is considered appropriate to add those n otes in subsection 1.1.3. of Part 1 of Annex VI.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Pursuant to Article 53a(4) of Regulation (EC) No 1272/2008, experts designated by each 
Member State were  consulted in the relevant expert group CARACAL (Competent authorities 
for REACH and CLP). In accordance with point s 10 and 11  of the Annex to the 
Interinstitutional Agreement on Better Law -Making of 13 April 20161 the European 
Parliament and the Council have been invited to participate in the CARACAL expert group.  
Stakeholders were consulted in the CARACAL expert group in accordance with point 6 of the 
Annex to that agreement.  
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.  
                                                 
1 Interinstitutional Agreement between the European Parliament, the Council of the European Union and 
the European Commission on Better Law -Making (OJ L 123, 12.05.2016, p. 1).   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending, for the purposes of its adaptation to technical and scientific progress, 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council on 
classification, labelling and packaging of substances and mixtures as regards the 
addition of n otes to Part 1, section 1.1.3.1, of Annex VI  
(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 
Counci l 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) Part 1, section 1.1.3.1, of Annex VI  to Regulation (EC) No 1272/2008 contains the list  
of notes which may be assigned to one or more harmonised classification and labelling 
entries and relate to the identification, classification and labelling of substance s as well 
as the classification and labelling of mixtures.  
(2) In its opinion  of 11 June 2020  concerning 2-ethylhexanoic acid  and its salts2, the 
Committee for Risk Assessment (RAC)  under the European Chemicals Agency  
recommended to add  a new note  to Part 1 , section 1.1.3.1,  of Annex VI to  Regulation 
(EC) No 1272/2008 , to clarify that the classification  covering a group of substances  in 
the same entry  is only based on the hazardous properties of th at part of the substance 
which is common to all substances in that entry . According to RAC, f or the non -
common parts of a substance, it is necessary to  assess if their hazardous properties 
may warrant a more severe classification  (higher category)  or a broader classification 
(including additional differ entiation, target organs and/or hazard statements) for the 
same hazard class. A new note X should therefore be added to Part 1 , section 1.1.3.1,  
of Annex VI to Regulation (EC) 1272/2008 . As that note  is likely to be assigned to 
other substances with the sa me properties in the future, it should be worded in such 
way that it is not limited to that specific entry.  
(3) The RAC ’s opinion of 20 September 2019 concerning boric acid , diboron trioxide , 
tetraboron disodium heptaoxide hydrate , disodium tetraborate anhydro us, orthoboric 
acid sodium salt , disodium tetraborate decahydrate  and disodium tetraborate 
pentahydrate3 as well as the RAC ’s opinion of 11 June 2020 concerning  2-
ethylhexanoic acid and its salts , described scientific evidence that the reproductive 
toxicity of each of these substance groups is due to a molecular entity common to all 
                                                 
1 OJ L 353, 31.12.2008, p. 1 . 
2 https://echa.europa.eu/documents/10162/8740de5b -368d -55a7 -7955 -094ef602d760   
3 https://echa.europa.eu/documents/10162/584263da -199c -f86f-9b73 -422a4f22f1c3    
EN 3  EN members of the respective  group.  When considering proposals for harmonised 
classification of certain boron compounds and of 2 -ethylhexanoic acid and its salts, 
Member State  experts consulted in the CARACAL expert group (Competent 
Authorities for Registration, Evaluation, Aut horisation and Restriction of Chemicals  
(REACH) and Classification, Labelling and Packaging ( CLP))  requested to add new 
notes in Part 1 , section 1.1.3.2,  of Annex VI to Regulation (EC) No 1272/2008 . 
According to the discussion in the CARACAL expert group , these notes are necessary 
to allow a more accurate identification of the hazard of  mixtur es, whic h contain  
several substances  belong ing to the same  ‘group  entry’. The principle of additivity  
should apply to substances whose hazard is due  to the presence or formation  of a 
common molecular entity . As a consequence, it is necessary  to take account of the 
contribution of these substances to the overall hazardous property of the mixture in 
proportion to their concentration , by comparing the applicable generic or specific 
concentration limit with the sum of the concentrations of the substances present . 
Therefore, two new note s, note  11 and 12, should be added to Part 1 , section 1.1.3. 2, 
of Annex VI to Regulation (EC) 1272/2008. As note 11 should be assigned to boric 
acids and its salts only, in view of the specificity of th e concerned  entries , it should be 
worded in such way that it is specific for  those entries. As note 12 is likely to be 
assigned in the future to substances  other than 2 -ethylhexanoic acid and its salts,  it 
should be worded in such way that it is not limited to that specific entry.  
(4) Regulation (EC) No 1272/2008 should therefore be amended accordingly , 
 
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendments to Regulation (EC) No 1272/2008  
Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this 
Regulation.  
Article  2 
Entry into force  
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union .  
 
This Regulation shall be binding in its entirety and directly applicable in all Membe r States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursu la VON DER LEYEN