EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) 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   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 on 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 b e 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 pu blic 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 RE ACH 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 wer e 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 Regulati on (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  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulatio n (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 1907/2 0061, and in particular Article 37(5) thereof ,  
Whereas:  
(1) Table 3 of Part 3 of Annex VI to  Regulation (EC) No 1272/2008 contains the list of 
harmonised classification and labelling of hazardous substances based on the criteria 
set out in Parts 2 to 5 of Ann ex 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 Agen cy (the ‘Agency’) 
pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk 
Assessment of the Agency (RAC) adopted , after having ta ken account of the 
comments received from the parties concerned , the following opinions2 on those 
proposals :  
– Opinion of 5 December 2019  concerning silanamine, 1,1,1 -trimethyl -N-
(trimethylsilyl) -, hydrolysis products with silica; pyrogenic, synthetic 
amorphous, nano, surface treated silicon dioxide ; 
– Opinion of 4 May 2020 concerning cyfluthrin  (ISO); α-cyano -4-fluoro -3-
phenoxybenzyl -3-(2,2-dichlorovinyl) -2,2-dimethylcyclopropanecarboxylate ; 
– Opinion of 4 May 2020 concerning beta-cyfluthrin (ISO); reaction mass of rel -
(R)-cyano(4 -fluoro -3-phenoxyphenyl)methyl (1 S,3S)-3-(2,2-dichloroethenyl) -
                                                 
1 OJ L 353, 31.12.2008, p. 1  
2 The opinions are accessible via the following website: https://echa. europa.eu/registry -of-clh-intentions -
until-outcome/ -/dislist/name/ -/ecNumber/ -/casNumber/ -/dte_receiptFrom/ -/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_assessmentFrom/ -
/dte_assessmentTo/ -/prc_regulatory_programme/ -/. – The opinion s of 11 June 2020 and of 10 
December 2020 concerning a reassessment at the request of the European Commission are accessible 
via the following website: https://echa.europa. eu/about -us/who -we-are/committee -for-risk-
assessment/opinions -of-the-rac-adopted -under -specific -echa-s-executive -director -requests  EN 3  EN 2,2-dimethylcyclopropane -1-carboxylate and rel -(R)-cyano(4 -fluoro -3-
phenoxyphenyl)methyl (1 S,3R)-3-(2,2-dichloroethenyl) -2,2-
dimethylcyclopropane -1-carboxylate ; 
– Opinion of 4 May 2020 concerning acetamiprid (ISO); (1 E)-N-[(6-
chloropyridin -3-yl)methyl] -N'-cyano -N-methylethanimidamide; ( E)-N1-[(6-
chloro -3-pyridyl)methyl] -N2-cyano -N1-methylacetamidine ; 
– Opinion of 11 June 2020 concerning tellurium;  
– Opinion of 11 June 2020 concerning tellurium dioxide;  
– Opinion of 11 June 2020 concerning 2,2-dimethylpropan -1-ol, tribro mo 
derivative; 3 -bromo -2,2-bis(bromomethyl)propan -1-ol; 
– Opinion of 11 June 2020 concerning piperonyl butoxide (ISO); 2 -(2-
butoxyethoxy)ethyl 6 -propylpiperonyl ether ; 
– Opinion of 11 June 2020 concerning benzophenone;  
Opinion of 11 June 2020 concerning exo-1,7,7 -trimethylbicyclo[2.2.1]hept -2-
yl acrylate; isobornyl acrylate ; 
– Opinion of 11 June 2020 concerning daminozide (ISO); 4 -(2,2-
dimethylhydrazino) -4-oxobutanoic acid; N-dimethylaminosuccinamic acid ; 
– Opinion of 11 June 2020 concerning clofentezine (ISO); 3,6 -bis(o-
chlorophenyl) -1,2,4,5 -tetrazine ; 
– Opinion of 11 June 2020 concerning fluopicolide (ISO); 2,6 -dichloro -N-[3-
chloro -5-(trifluoromethyl) -2-pyridylmethyl]benzamide ; 
– Opinion of 11 June 2020 concerning trichlorosilane ; 
– Opinion of 11 June 2020 con cerning 2 -ethylhexanoic acid and its salts;  
– Opinion of 11 June 2020 concerning a reassessment at the request of the 
European Commission of the developmental toxicity of N -
carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) (DTPA) and its 
pentasodium and pentapotassium salts  
– Opinion of 17 September 2020 concerning dibutylin bis(2 -ethylhexanoate);  
– Opinion of 17 September 2020 concerning dibutylin di(acetate);  
– Opinion of 17 September 2020 concerning barium diboron tetraoxide;  
– Opinion of 17 September 202 0 concerning quinoclamine (ISO); 2 -amino -3-
chloro -1,4-naphthoquinone ; 
– Opinion of 17 September 2020 concerning 4,4'-
oxydi(benzenesulphonohydrazide) ; 
– Opinion of 17 September 2020 toluene -4-sulphonohydrazide ; 
– Opinion of 17 September 2020 concerning theophylli ne; 1,3 -dimethyl -3,7-
dihydro -1H-purine -2,6-dione ; 
– Opinion of 17 September 2020 concerning 1,3-bis(1 -isocyanato -1-
methylethyl)benzene; [ m-TMXDI] ; 
– Opinion of 17 September 2020 concerning Bis(isocyanatomethyl)benzene; [ m-
XDI] ; EN 4  EN – Opinion of 17 September 2020 con cerning 2,4,6 -triisopropyl -m-phenylene 
diisocyanate ; 
– Opinion of 17 September 2020 concerning N-(2-nitrophenyl)phosphoric 
triamide ; 
– Opinion of 17 September 2020 concerning cumene;  
– Opinion of 17 September 2020 concerning 2 -ethyl -2-[[(1-
oxoallyl)oxy]methyl] -1,3-propanediyl diacrylate; 2,2 -
bis(acryloyloxymethyl)butyl acrylate;trimethylolpropane triacrylate;  
– Opinion of 17 September 2020 concerning 1,5 -naphthylene diisocyanate  
[containing < 0.1 % (w/w) of particles with an aerodynamic diameter of below 
50 µm];  
– Opinion of 17 September 2020 concerning 1,5 -naphthylene diisocyanate  
[containing ≥ 0.1 % (w/w) of particles with an aerodynamic diameter of below 
50 µm];  
– Opinion of 8 October 2020 concerning ammonium bromide ; 
– Opinion of 8 October 2020 concerning 2,4,6 -tri-tert-butylphenol ; 
– Opinion of 8 October 2020 concerning pyridalyl (ISO); 2,6 -dichloro -4-(3,3-
dichloroallyloxy)phenyl 3 -[5-(trifluoromethyl) -2-pyridyloxy]propyl ether ; 
– Opinion of 8 October 2020 concerning p yridine -2-thiol 1 -oxide, sodium salt; 
pyrithione sodium; sodium pyrithione ; 
– Opinion of 8 October 2020 concerning N-(5-chloro -2-isopropylbenzyl) -N-
cyclopropyl -3-(difluoromethyl) -5-fluoro -1-methyl -1H-pyrazole -4-
carboxamide; isoflucypram ; 
– Opinion of 8 October 2020 concerning 2-(2-methoxyethoxy)ethano l; 
diethylene glycol monomethyl ether ; 
– Opinion of 8 October 2020 concerning 4,4’-isopropylidenediphenol; bisphenol 
A; 
– Opinion of 8 October 2020 concerning pendimethalin (ISO); N-(1-
ethylpropyl) -2,6-dinitro -3,4-xylidene ; 
– Opinion of 8 October 2020 concerning dimoxystrobin (ISO); (2 E)-2-{2-[(2,5 -
dimethylphenoxy)methyl]phenyl} -2-(methoxyimino) -N-methylacetamide; ( E)-
2-(methoxyimino) -N-methyl -2-[α-(2,5-xylyloxy) -o-tolyl]acetamide ; 
– Opinion of 10 December 2020 concerning 4,4’-sulphonyldiphenol; bisphenol 
S; 
– Opinion of 10 December 2020 2-[N-ethyl -4-[(5-nitrothiazol -2-yl)azo] -m-
toluidino]ethyl acetate; C.I. Disperse Blue 124 ; 
– Opinion of 10 December 2020 concerning p erfluoroheptanoic acid; 
tridecafluoroheptanoic acid ; 
– Opinion of 10 December 2020 concerning methyl N-(isopropoxycarbonyl) -L-
valyl -(3RS)-3-(4-chlorophenyl) -β-alaninate; valifenalate ; EN 5  EN – Opinion of 10 December 2020 concerning 6-[C12 -18-alkyl -(branched, 
unsaturated) -2,5-dioxopyrrolidin -1-yl]hexanoic acid, sodium and tris(2 -
hydroxyethyl)ammonium salts ; 
– Opinion of 10 December 2020 concerning 6-[(C10 -C13) -alkyl -(branched, 
unsaturated) -2,5-dioxopyrrolidin -1-yl]hexanoic acid ; 
– Opinion of 10 December 2020 concerning 6-[C12 -18-alkyl -(branched, 
unsaturated) -2,5-dioxopyrrolidin -1-yl]hexan oic acid ; 
– Opinion of 10 December 2020 concerning 1,3,5 -triazine -2,4,6 -triamine;  
Melamine ; 
– Opinion of 10 December 2020 concerning r eaction mass of 3 -(difluoromethyl) -
1-methyl -N-[(1RS,4SR,9RS)-1,2,3,4 -tetrahydro -9-isopropyl -1,4-
methanonaphthalen -5-yl]pyrazole -4-carboxamide and 3 -(difluoromethyl) -1-
methyl -N-[(1RS,4SR,9SR)-1,2,3,4 -tetrahydro -9-isopropyl -1,4-
methanonaphthalen -5-yl]pyrazole -4-carboxamide [>78% syn isomers <15% 
anti isomers relativ e content]; isopyrazam ; 
– Opinion of 10 December 2020 concerning Margosa, ext. [from the kernels of 
Azadirachta indica extracted with water and further processed with organic 
solvents] ; 
– Opinion of 10 December 2020 concerning divanadium pentaoxide; vanadium 
pentoxide ; 
– Opinion of 10 December 2020 concerning bentazone (ISO); 3 -isopropyl -2,1,3 -
benzothiadiazine -4-one-2,2-dioxide ; 
– Opinion of 10 December 2020 concerning a reassessment at the request of the 
European Commission of the new information on acute inhalati on toxicity of 
2-butoxyethanol; ethylene glycol monobutyl ether (EGBE)  
 
(3) Additional information was received contesting the scientific assessment set out in the 
RAC opinions of  5 December 2019  concerning silanamine, 1,1,1 -trimethyl -N-
(trimethylsilyl) -, hydrolysis products with silica; pyrogenic, synthetic amorphous, 
nano, surface treated silicon dioxide ; of 11 June 2020 concerning  2-ethylhexanoic acid 
and its salts; of 11 June 2020 concerning a reassessment at the request of the European 
Commission of th e developmental toxicity of N -carboxymethyliminobis 
(ethylenenitrilo)tetra(acetic acid) (DTPA) and its pentasodium and pentapotassium 
salts; of 8 October 2020 concerning ammonium bromide ; of 10 December 2020 
concerning divanadium pentaoxide ; of 10 December  2020 concerning a reassessment 
at the request of the European Commission of the new information on acute inhalation 
toxicity of 2 -butoxyethanol; ethylene glycol monobutyl ether (EGBE) ; and of 10 
December 2020 concerning melamin e.  
(4) The additional information was assessed and was not found sufficient to cast doubts 
on the scientific analysis contained in th e RAC opinions. It is therefore appropriate to 
introduce , update or delete the harmonised classification and labelling of the 
substances concerne d on the basis of the assessment made in those opinions.  
(5) Regulation (EC) No 1272/2008 should therefore be amended accordingly.  
(6) Compliance with the new or updated harmonised classifications should not be required 
immediately as a certain period of time is n ecessary to allow suppliers to adapt the EN 6  EN labelling and packaging of substances and mixtures to the new or updated 
classifications and to sell existing stocks subject to the pre -existing regulatory 
requirements. That period of time is also necessary to allo w suppliers sufficient time to 
take the actions required to ensure continuing compliance with other legal 
requirements following 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 this 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  
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 . 
It shall apply from … [Publications Office, please insert a date corresponding to 18 months 
after the entry into force of this Regulation. The date should be the first day of the 
following  mont h] 
By way of derogation from the second paragraph of this Article , substances and mixtures may 
be classified, labelled and packaged in accordance with this Regulation from its date of entry  
into force .   
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