EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft 
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending 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 
modification of entries in Part 3 of Annex VI for 2 -ethylhexanoic acid and its salts, b oric 
acid, diboron trioxide, tetraboron disodium heptaoxide hydrate, disodium tetraborate 
anhydrous, orthoboric acid sodium salt, disodium tetraborate decahydrate, and 
disodium tetraborate pentahydrate  
(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. Article 37(5) of Regulation (EC) 
No 1272/2008 empowers the Commission to include, without undue delay, su bstances in  
Table 3 of Part 3 of Annex VI, where it finds that the harmonisation of the classification and 
labelling is appropriate (Table 3.1 has been renamed Table 3 since the deletion of Table 3.2) . 
Based on  the opinions  issued by the Committee for Risk Assessment (RAC) of the European 
Chemicals Agency ( ECHA ), as well as taking into account  comments received from Member 
State  experts in the CARACAL expert group  (Competent Authorities for Registration, 
Evaluation, Aut horis ation and Restriction of Chemicals  (REACH) and Classification, 
Labelling and Packaging ( CLP)), it is appropriate to update the harmonised classification and 
labelling of certain substances  by assigning to them the notes that have been recently added to 
Part 1 of Annex VI to Regulation (EC) No 1272/2008  and to amend Table 3 of Part 3 of 
Annex VI to Regulation (EC) No 1272/2008 accordingly.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
In accordance with Article 37(4) of Regulation (EC) No 1272/2008,  ECH A has performed a 
public consultation for each substance to be included  in or modified in Table 3 of Part 3 of 
Annex VI , before the adoption of the respective opinion on the proposals for harmonised 
classification and labelling by its Committee for Risk Assessment  (RAC). The comments 
provided in the course of the public consultations have  been taken into account by RAC and 
the Commission.  
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 Bet ter Law -Making of 13 April 20161 the European 
Parliament and the Council have been invit ed to participate in the CARACAL expert group . 
Stakeholders were consulted in the CARACAL expert group i n 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 37(5) 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 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 
modification of entries in Part 3 of Annex VI for 2 -ethylhexanoic acid and its salts, b oric 
acid, diboron trioxide, tetraboron disodium heptaoxide hydrate, disodium tetraborate 
anhydrous, orthoboric acid sodium salt, disodium tetraborate decahydrate, and 
disodium tetraborate pentahydrate  
(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, amend ing and repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/20061, and in particular Article 37(5) thereof ,  
 
Whereas:  
(1) Part 3 , Table 3 , of Annex VI to Regulation (EC) No 1272/2008 contains a list of 
harmonised classificatio n and labelling of hazardous substances based on the criteria 
set out in Parts 2 to 5 of Annex I to that Regulation.  
(2) Proposals to introduce harmonised classification and labelling of certain substances 
and to update  or delete the harmonised classification and labelling of certain other 
substances have been submitted to the European Chemicals Agency  (the ‘Agency’) 
pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk 
Assessment of the Agency ( the ‘ RAC ’) adopted opinions on those proposals, after 
having ta ken account of the comments received from the parties concerned.  
(3) The RAC ’s opinion of 20 September 2019 concerning boric acid , diboron trioxide , 
tetraboron disodium heptaoxide hydrate , disodium tetraborate anhydrous , orthoboric 
acid sodium salt , disodium tetraborate decahydrate and disodium tetraborate 
pentahydrat e2, as well as the RAC ’s opinion of 11 June 2020 concerning  2-
ethylhexanoic acid and its salts3, described scientific evidence indicating that the 
reproductive toxicity o f each of th ose substance groups is due to a molecular entity 
common to all members of a substance group. M ember  State  experts consulted in t he 
Commission expert group CARACAL  (Competent Authorities for Registration, 
Evaluation, Aut horisation and Restriction of Ch emicals  (REACH) and Classification, 
Labelling and Packaging ( CLP) ) therefore requested the addition of notes to the entries  
                                                 
1 OJ L 353, 31.12.2008, p. 1  
2 https://echa.europa.eu/documents/10162/584263da -199c -f86f-9b73 -422a4f22f1c3   
3  https://echa.europa.eu/documents/10162/8740de5b -368d -55a7 -7955 -094ef602d760    
EN 3  EN related to the substance groups referred to in those  RAC opinions   of 2019 and 2020 , 
in order to address the situat ion in which  several substances belonging to one of those 
group s are present together in a mixture and to provide that the applicable 
concentration limit for classification of the mixture is to be compared with the sum of 
the concentrations of th ose substa nces. Th ose notes were added to Part 1 , section  
1.1.3.2 , of Annex VI to Regulation (EC) No 1272/2008 by Commission Delegated 
Regulation  (EU) …/….4 [[PO add reference to Commission Delegated Regulation  
which includes the notes  once adopted ] as note 11 and note 12 . It is therefore 
appropriate to add a reference to note 11 to the entries for boric acid, diboron trioxide,  
tetraboron disodium heptaoxide hydrate, disodium tetraborate anhydrous, orthoboric 
acid sodium salt,  disodium tetraborate decahydrate  and di sodium tetraborate 
pentahydrate  and a reference to note 12 to the entr y for 2 -ethylhexanoic acid and its 
salts. 
(4) In its opinion of 11 June 2020 concerning 2 -ethylhexanoic acid and its salts , the RAC 
recommended adding  a note to this entry, in order to address the possibility that, while 
the entry for this group of substances is based on the toxic properties of a common part 
of those substances, another, substance -specific, part of the substances may warrant 
classificati on in a higher category or classification with a broader  scope, e.g. including 
additional differentiation, target organs and/or hazard statements , for certain 
substances in the  entry. Such  note was added to Part 1 , section 1.1.3.1 , of Annex VI to 
Regulati on (EC) No 1272/2008 by Commission Delegated Regulation  (EU) …/… 
[add reference to Commission Delegated Regulation which includes the note once 
adopted ] as note X . It is therefore appropriate to add a reference to note X to the entry 
concerning 2 -ethylhexa noic acid and its salts.  
(5) Member State experts consulted in the CARACAL expert group suggested  that the 
current note A  should be applicable to  2-ethylhexanoic acid and its salts . Note A 
prescribes  that for substances covered by an entry with a general description , such as 
‘…compounds’ or ‘…salts’, the supplier is required to state on the label the correct 
name. As the entry for 2-ethylhexanoic acid and its salts bears such a general 
description, a reference to note A should be added  to the entry.  
(6) As Co mmission Delegated Regulation XX/20XX [ PO add reference to Commission 
Delegated Regulation which includes the notes once adopted ] was adopted on [XX], 
the notes  included in that Regulation  could not be inserted in Table 3 of Annex VI at 
the time of the ado ption of Commission Delegated Regulation (EU) 2021/8495 and 
Commission Delegated Regulation  (EU) 2022/6926 which added the respective entries 
to Table 3 of Annex VI  to Regulation (EC) No 1272/2008 . It is therefore necessary to 
update the entries  concerning  boric acid;  diboron trioxide; tetraboron disodium 
heptaoxide hydrate; disodium tetraborate anhydrous; orthoboric acid sodium salt; 
disodium tetraborate decahydrate; disodium tetraborate pentahydrate , by adding 
reference to note 11 to each of them. It is a lso necessary to update entry concerning 2-
ethylhexanoic acid and its salts by adding a reference to note 12 and note X to that 
entry .  
(7) Regulation (EC) No 1272/2008 should therefore be amended accordingly.  
(8) Compliance with the revised  harmonised classifications should not be required 
immediately as suppliers need some time to adapt the labelling and packaging of 
                                                 
4 OJ L ……  
5 OJ L188, 28.5.2021, p.27  
6 OJ L129, 3.5.202, p. 1   
EN 4  EN substances and mixtures to the revised harmonised classifications and to sell existing 
stocks  of substances and mixtures . That  period of time would  also allow  suppliers to 
take the actions required to ensure compliance with other requirements set out in  
Regulation (EC) No 1272/2008 , as amended by this Regulation. Suppliers should, 
however, have the possibility to apply the revised  harmonised classifications, and to 
adapt the labelling and packaging accordingly, on a voluntary basis as from the entry 
into force of this Regulation , to ensure a high level of protection of human health and 
of the environment and to provide suffi cient flexibility to suppliers ,  
 
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 and application  
 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
Article 1  shall apply from … [ PO: please insert the date corresponding to the first day of the 
month following the date 18 months after the entry into force of this Regulation ]. 
Suppliers may classify, label and package substances and mixtures listed in the Annex to this 
Regulation in accordance with Regulation (EC) No 1272/2008, as amended by this 
Regula tion, as from [OP – please insert date of entry into force of this Regulation] .   
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursu la VON DER LEYEN