EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2024) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council 
as regards the harmonised classification and labelling of certain substances  
(Text with EEA relevance)    
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 the comments received from 
Member States and stakeholders , it is appropriate to introduce or  update the harmonised 
classification and  labelling of certain substances  and 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,  ECHA 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). Th e 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 invited 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 
as regards the harmonised classification and labelling of certain substances  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioni ng 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 an d 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 the list of 
harmonised classification and labelling of hazardous substances ba sed 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 (RAC) of the Agency adopted , after having taken account of the 
comments received from the parties concerned, the following opinions2 on those 
proposals :  
– Opinion of 18 March 2022 concerning multi-walled carbon tubes (synthetic 
graphite in tubular shape) with a geometric tube diamete r range ≥ 30 nm to < 3 
µm and a length ≥ 5 µm and aspect ratio ≥ 3:1, including multi-walled carbon 
nanotubes, MWC(N)T ; 
– Opinion of 18 March 2022 concerning α -methyl -1,3-benzodioxole -5-
propionaldehyde [1] ( S)-α-methyl -1,3-benzodioxole -5-propionaldehyde;  
(2S)-3-(1,3-benzodioxol -5-yl)-2-methylpropanal [2] ( R)-α-methyl -1,3-
benzodioxole -5-propionaldehyde; (2 R)-3-(1,3-benzodioxol -5-yl)-2-
methylpropanal [3] ; 
– Opinion of 18 March 2022 concerning acetone oxime ; 
                                                 
1 OJ L 353, 31.12.2008, p. 1 , ELI:  http://data.europa.eu/eli/reg/2008/1272/oj . 
2 The opinions are accessible via the following website: https://echa.europa.eu/registry -of-clh-intentions -
until-outcome/ -/dislist/name/ -/ecNumber/ -/casNumber/ -/dte_re ceiptFrom/ -/dte_receiptTo/ -
/prc_public_status/Opinion+Adopted/dte_withdrawnFrom/ -/dte_withdrawnTo/ -
/sbm_expected_submissionFrom/ -/sbm_expected_submissionTo/ -/dte_finalise_deadlineFrom/ -
/dte_finalise_deadlineTo/ -/haz_addional_hazard/ -/lec_submitter/ -/dte_as sessmentFrom/ -
/dte_assessmentTo/ -/prc_regulatory_programme/ -/.    
EN 3  EN – Opinion of 18 March 2022 concerning (3E)-dec-3-en-2-one; 
– Opinion of 18 March 2022 concerning 2,3 -epoxypropyl neodecanoate ; 
– Opinion of 18 March 2022 concerning propyl 3,4,5 -trihydroxybenzoate ; 
– Opinion of 18 March 2022 concerning benthiavalicarb -isopropyl (ISO); 
isopropyl [( S)-1-{[(R)-1-(6-fluoro -1,3-benzothiazo l-2-yl)ethyl]carbamoyl} -2-
methylpropyl]carbamate ; 
– Opinion of 18 March 2022 concerning hexyl salicylate ; 
– Opinion of 18 March 2022 concerning sulfur ; 
– Opinion of 18 March 2022  concerning reaction mass of N,N'-ethane -1,2-
diylbis(decanamide) and 12 -hydroxy -N-[2-[(1-
oxodecyl)amino]ethyl]octadecanamide and N,N'-ethane -1,2-diylbis(12 -
hydroxyoctadecanamide) [1 ] reaction mass of N,N'-ethane -1,2-
diylbis(decanamide) and 12 -hydroxy -N-[2-[(1-
oxodecyl)amino]ethyl]octadecanamide [2] ; 
– Opinion of 18 March 2022 concerning 2-[ethyl[3 -methyl -4-[(5-nitrothiazol -2-
yl)azo]phenyl]amino]ethanol ; 
– Opinion of 30 May concerning glyphosate (ISO); N-
(phosphonomethyl )glycine ; 
– Opinion of 2 June 2022 concerning silver massive: [particle diameter ≥ 1 mm] ; 
– Opinion of 2 June 2022 concerning silv er powder: [particle diameter > 100 nm 
< 1 mm] ; 
– Opinion of 2 June 2022 concerning silver nano: [particle diameter > 1 nm ≤ 
100 nm] ; 
– Opinion of 2 June 2022 concerning S-metolachlor (ISO); 2 -chloro -N-(2-ethyl -
6-methylphenyl) -N-[(2S)-1-methoxypropan -2-yl]acetamide; (RaSa) -2-chloro -
N-(6-ethyl -o-tolyl) -N-[(1S) -2-methoxy -1-methylethyl]acetamide [contains 80 -
100% 2 -chloro -N-(2-ethyl -6-methylphenyl) -N-[(2S)-1-methoxypropan -2-
yl]acetamide and 0 -20% 2 -chloro -N-(2-ethyl -6-methylphenyl) -N-[(2R)-1-
methoxypropan -2-yl]acetamide] ; 
– Opinion of 2 June 2022 concerning 2-(dimethylamino) -2-[(4-
methylphenyl)methyl] -1-[4-(morpholin -4-yl)phenyl]butan -1-one; 
– Opinion of 2 June 2022 concerning formaldehyde … %; 
– Opinion of 2 June 2022 concerning formic acid .. . %; 
– Opinion of 2 June 2022 concerning dicamba (ISO); 2,5 -dichloro -6-
methoxybenzoic acid; 3,6 -dichloro -2-methoxybenzoic acid ; 
– Opinion of 2 June 2022 concerning 7-oxabicyclo[4.1.0]hept -3-ylmethyl 7 -
oxabicyclo[4.1.0]heptane -3-carboxylate ; 
– Opinion of 2 June 2 022 concerning peracetic acid …  %; 
– Opinion of 2 June 2022 concerning tetrasodium 4 -amino -5-hydroxy -3,6-bis[[4 -
[[2-(sulphonatooxy) ethyl]sulphonyl]phenyl]azo]naphthalene -2,7-disulphonate 
[1] Reaction products of 4 -amino -5-hydroxynaphthalene -2,7-disulfonic a cid, 
coupled twice with diazotized 2 -[(4-aminophenyl)sulfonyl]ethyl hydrogen  
EN 4  EN sulfate, sodium salts [2] disodium 4 -amino -5-hydroxy -3,6-bis{[4 -
(vinylsulfonyl) phenyl]diazenyl}naphthalene -2,7-disulfonate [3] ; 
– Opinion of 15 September 2022 concerning perboric a cid, sodium salt [1]  
perboric acid, sodium salt, monohydrate [2]  
perboric acid (HBO(O 2)), sodium salt, monohydrate [3] sodium peroxoborate 
[4] 
sodium perborate [5];  
– Opinion of  15 September 2022 concerning perboric acid (H 3BO 2(O2)), 
monosodium salt trihydrate [1] perboric acid, sodium salt, tetrahydrate [2] 
perboric acid (HBO(O 2)), sodium salt, tetrahydrate [3] sodium peroxoborate, 
hexahydrate [4]  
– Opinion of 15 September 2022 concerning sodium peroxometaborate ; 
– Opinion of 15 September 2022 concerning trimethyl borate ; 
– Opinion of 15 September 2022 concerning ethanethiol;  
ethyl mercaptan ; 
– Opinion of 15 September 2022 concerning 1H-benzotriazole ; 
– Opinion of 15 September 2022 concerning methyl -1H-benzotriazole ; 
– Opini on of 15 September 2022 concerning N,N'-methylenediacrylamide ; 
– Opinion of 15 September 2022 concerning Sodium 3-(allyloxy) -2-
hydroxypropanesulphonate ; 
– Opinion of 1 December 2022 concerning tert-butyl 2 -ethylperoxyhexanoate ; 
– Opinion of 1 December 2022 concerning n-hexane ; 
– Opinion of 1 December 2022 concerning biphenyl -2-ol; 2 -phenylphenol; 2 -
hydroxybiphenyl ; 
– Opinion of 1 December 2022 concerning copper; [specific surface area > 0.67 
mm2/mg] ; 
– Opinion of 1 December 2022 concerni ng reaction mass of 1,3 -dioxan -5-ol and 
1,3-dioxolan -4-ylmethanol ; 
– Opinion of 1 December 2022 concerning 1,4-dichloro -2-nitrobenzene ; 
– Opinion of 1 December 2022 concerning 2,4 -dimethylcyclohex -3-ene-1-
carbaldehyde [1] (1α,2α,5α) -2,5-dimethylcyclohex -3-ene-1-carbaldehyde [2] 
2,6-dimethylcyclohex -3-ene-1-carbaldehyde [3] 3,5 -dimethylcyclohex -3-ene-
1-carbaldehyde [4] 3,6 -dimethylcyclohex -3-ene-1-carbaldehyde [5] 4,6 -
dimethylcyclohex -3-ene-1-carbaldehyde [6] reaction mass of 3,5 -
dimethylcyclohex -3-ene-1-carbald ehyde and 2,4 -dimethylcyclohex -3-ene-1-
carbaldehyde [7] dimethylcyclohex -3-ene-1-carbaldehyde [8] 
Dimethylcyclohex -3-ene-1-carbaldehyde [9] 1,2,4(or 1,3,5) -trimethylcyclohex -
3-ene-1-carbaldehyde [10] 1,3,4 -trimethylcyclohex -3-ene-1-carbaldehyde [11] 
2,2,4 -trimethylcyclohex -3-ene-1-carbaldehyde [12] 2,4,6 -trimethylcyclohex -3-
enecarbaldehyde [13] isocyclocitral [14] 3,5,6 -trimethylcyclohex -3-ene-1-
carbaldehyde [15] 4,6,6 -trimethylcyclohex -3-ene-1-carbaldehyde [16] ;  
EN 5  EN – Opinion of 1 December 2022 concerning pyracl ostrobin (ISO); methyl N-(2-
{[1-(4-chlorophenyl) -1H-pyrazol -3-yl]oxymethyl}phenyl) N-methoxy 
carbamate ; 
– Opinion of 1 December 2022 concerning dibenzoyl peroxide; benzoyl 
peroxide ; 
– Opinion of 1 December 2022 concerning fenpropidin (ISO); ( R,S)-1-[3-(4-tert-
butylphenyl) -2-methylpropyl]piperidine . 
(3) The Commission has received additional information from stakeholders contesting the 
scientific assessment set out in the RAC opinion s of 18 March 2022 concerning 
benthiavalicarb -isopropyl, 2,3 -epoxypropyl neodecanoate, multi -walled carbon tubes, 
hexyl salicylate , in the RAC opinions of 2 June 2022 concerning silver massive, silver 
powder and silver nano  and in the RAC opinion s of 1 December 2022 concerning n-
hexane  and copper . The additional information has been assessed  by the Commission 
and has not been found sufficient to cast doubts on the scientific analysis contained in 
the RAC opinions.  
(4) With regard to the substance copper flakes (coated with aliphatic acid) (index number 
029-019-01-X), its entry  shoul d be amended by deleting  its classification  as hazardous 
for the aquatic environment which is now covered by the more generic entry copper; 
[specific surface area > 0.67 mm2/mg] ( index number 029 -026-00-0), inserted in the 
Annex .  
(5) With regard to the substance granulated copper (index number 029 -024-00-X), its 
entry should be deleted as it is covered by the more generic entry copper; [specific 
surface area > 0.67 mm2/mg] (index number 029 -026-00-0), inserted in the Annex . 
(6) In light of the RAC opinions, it is appropriate to introduce , update  or delete  the 
harmonised classification and labelling of the substances concerned on th e basis of the 
assessment made in those opinions  and following the further assessment s. 
(7) Regulation (EC) No 1272/2008 should theref ore be amended accordingly.   
(8) Compliance with the new or updated harmonised classifications should not be required 
immediately as a certain period of time is necessary to allow suppliers to adapt the 
labelling and packaging of substances and mixtures to the new or updated 
classificatio ns and to sell existing stocks subject to the pre -existing regulatory 
requirements. That period of time is also necessary to allow suppliers sufficient time to 
take the actions required to ensure continuing compliance with other legal 
requirements followin g the changes made under this Regulation. Suppliers should, 
however, have the possibility to apply the new or updated harmonised classifications, 
and to adapt the labelling and packaging accordingly, on a voluntary basis before the 
date of application of t his Regulation , to ensure a high level of protection of human 
health and of the environment and to provide sufficient flexibility to suppliers ,  
 
HAS ADOPTED THIS REGULATION:  
Article 1  
 
Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this 
Regulation.   
EN 6  EN 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 . 
It shall apply from … [OP: please insert the date = the first day of the month following 18 
months after the date of entry into force of this Regulation ]. However, substances and 
mixtures may be classif ied, label led and package d  in accordance with  Regulation (EC) No 
1272/2008 as amended by  this Regulation  from the date of entr y 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