EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EC) No 1272/2008 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 sub stance 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 cours e 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 authori ties 
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 3 7(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 as regards the harmonised classification and 
labelling of certain substances  
(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 classific ation, 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 37(5) thereof ,  
Whereas:  
(1) Table 3 of Part 3 of Annex VI to  Regulati on (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 Annex I to that Regulation.  
(2) Proposals to introduce harmonised classification and labelling of certain  substances 
and to update he 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 (RAC) adopted , after having ta ken account of the comments received from 
the parties concerned , the following opinions2 on those proposals :  
– Opinion of 18 March 2021 concerning 
benzyl(diethylamino)diphenylphosphonium 4 -[1,1,1,3,3,3 -hexafluoro -2-(4-
hydroxyphenyl)propan -2-yl]phenolate ; 
– Opinion of 18 March 2021 concerning benzyltriphenylphosphonium, salt with 
4,4'-[2,2,2 -trifluoro -1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) ; 
– Opinion of 18 March 2021 concerning reaction mass of 4,4' -[2,2,2 -trifluoro -1-
(trifluoromethyl)ethylidene]diphenol and 
                                                 
1 OJ L 353, 31.12.2008, p. 1  
2 The opinions are accessible via the following web site: https://echa.europa.eu/registry -of-clh-intentions -
until-outcom e/-/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_deadlineT o/-/haz_addional_hazard/ -/lec_submitter/ -/dte_assessmentFrom/ -
/dte_assessmentTo/ -/prc_regulatory_programme/ -/.  The opinion of 16 September 2021 concerning a 
reassessment at the request of the Commission is 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 benzyl(diethylamino)diphenylphosphonium 4 -[1,1,1,3,3,3 -hexafluoro -2-(4-
hydroxyphenyl)propan -2-yl]phenolate (1:1) ; 
– Opinion of 18 March 2021 concerning reaction mass of 4,4' -[2,2,2 -trifluoro -1-
(trifluoromethyl )ethylidene]diphenol and benzyltriphenylphosphonium, salt 
with 4,4' -[2,2,2 -trifluoro -1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) ; 
– Opinion of 18 March 2021 concerning 4,4'-[2,2,2 -trifluoro -1-
(trifluoromethyl)ethylidene]diphenol; bisphenol AF ; 
– Opinion of  18 March 2021 concerning cinnamaldehyde; 3 -phenylprop -2-enal;  
cinnamic aldehyde ; cinnamal [1], (2E) -3-phenylprop -2-enal [2];  
– Opinion of 18 March 2021 concerning benfluralin (ISO); N-butyl -N-ethyl -
α,α,α -trifluoro -2,6-dinitro -p-toluidine ; 
– Opinion 18 March 2 021 concerning 3,3'-dimethylbiphenyl -4,4'-diyl 
diisocyanate ; 
– Opinion of 18 March 2021 concerning foramsulfuron (ISO); 2 -{[(4,6 -
dimethoxypyrimidin -2-yl)carbamoyl]sulfamoyl} -4-formamido -N,N-
dimethylbenzamide; 1 -(4,6-dimethoxypyrimidin -2-yl)-3-(2-
dimethylcarb amoyl -5-formamidophenylsulfonyl)urea ;  
– Opinion of 18 March 2021 concerning ethyl acrylate ; 
– Opinion of 18 March 2021 concerning methyl acrylate;  
methyl propenoate;  
– Opinion of 18 March 2021 concerning methyl methacrylate ; methyl 2 -
methylprop -2-enoate ; methyl  2-methylpropenoate ; 
– Opinion of  18 March 2021 concerning transfluthrin (ISO); 2,3,5,6 -
tetrafluorobenzyl (1 R,3S)-3-(2,2-dichlorovinyl) -2,2-
dimethylcyclopropanecarboxylate ; 
– Opinion of 18 March 2021 concerning allyl methacrylate;  2-methyl -2-
propenoic acid 2-propenyl ester;  
– Opinion of 18 March 2021 concerning mepiquat chloride (ISO); 1,1 -
dimethylpiperidinium chloride ; 
– Opinion of 10 June 2021 concerning triethylamine ; 
– Opinion of 10 June 2021 concerning di-n-butylamine ; 
– Opinion of 10 June 2021 concerning 4-nitrosomorpholine ; 
– Opinion of 10 June 2021 concerning difenoconazole (ISO); 1 -({2-[2-chloro -4-
(4-chlorophenoxy)phenyl] -4-methyl -1,3-dioxolan -2-yl}methyl) -1H-1,2,4 -
triazole; 3 -chloro -4-[(2RS,4RS;2RS,4SR) -4-methyl -2-(1H-1,2,4 -triazol -1-
ylmethyl) -1,3-dioxolan -2-yl]phenyl 4 -chlorophenyl ether ; 
– Opinion 10 June 2021 concerning N,N-dimethyl -p-toluidine ; 
– Opinion of 10 June 2021 concerning potassium chlorate ; 
– Opinion of 10 June 2021 concerning sodium chlorate ; 
– Opinion of 10 June 2021 Concerning reaction mass of 1 -(2,3-epoxypropoxy) -
2,2-bis ((2,3 -epoxypropoxy)methyl) butane and 1 -(2,3-epoxypropoxy) -2-((2,3 -
epoxypropoxy)methyl) -2-hydroxymethyl butane;  EN 4  EN – Opinion of 10 June 2021 concerning metribuzin (ISO); 4 -amino -6-tert-butyl -3-
methylthio -1,2,4 -triazin -5(4H)-one; 4 -amino -4,5-dihydro -6-(1,1-
dimethylethyl) -3-methylthio -1,2,4 -triazin -5-one;  
– Opinion 16 September 2021 concerning lithium carbonate [1] lithium chloride 
[2] lithium hydroxide [3] ; 
– Opinion of 16 September 2021 concerning dimethyl propylphosphonate ; 
– Opinion of 16 September 2021 concerning dibutyltin maleate ; 
– Opinion of 16 September 2021 concerning dibutyltin oxide ; 
– Opinion of 16 September 2021 concerning clothianidin (ISO); ( E)-1-(2-chloro -
1,3-thiazol -5-ylmethyl) -3-methyl -2-nitroguanidine ; 
– Opinion of 16 September 2021 concerning cymoxanil (ISO); 2 -cyano -N-
[(ethylamino)carbo nyl]-2-(methoxyimino)acetamide;  
– Opinion of 16 September 2021 concerning nonylphenol, branched and linear, 
ethoxylated (with average molecular weight < 352 g/mol) [includes ortho -, 
meta-, para - isomers or any combination thereof] ; 
– Opinion of 16 September 2021 concerning nonylphenol, branched and linear, 
ethoxylated (with 352 g/mol ≤ average molecular weight < 704 g/mol) 
[includes ortho -, meta -, para - isomers or any combination thereof] ;  
– Opinion of 16 September 2021 concerning nonylphenol, branched and linear, 
ethoxylated (with 704 g/mol ≤ average molecular weight ≤ 1540 g/mol) 
[includes ortho -, meta -, para - isomers or any combination thereof] ;  
– Opinion of 16 September 2021 concerning 1-phenylethan -1-one (1 -
phenylethylidene)hydrazone ; 
– Opinion of 16 September 2021 concerning 9-[2-(ethoxycarbonyl)phenyl] -3,6-
bis(ethylamino) -2,7-dimethylxanthylium chloride; Basic Red 1 ;  
– Opinion of 16 September 2021 concerning picolinafen (ISO); N-(4-
fluoro phenyl) -6-[3-(trifluoromethyl)phenoxy]pyridine -2-carboxamide; 4′ -
fluoro -6-[(α,α,α -trifluoro -m-tolyl)oxy]picolinanilide ;  
– Opinion of 16 September 2021 concerning diuron (ISO); 3 -(3,4-
dichlorophenyl) -1,1-dimethylurea ;  
– Opinion of 16 September 2021 concerning diphenyl(2,4,6 -
trimethylbenzoyl)phosphine oxide ;  
– Opinion of 16 September 2021 concerning hydrogen sulphide, hydrogen 
sulfide ;  
– Opinion of 16 September 2021 concerning benzyl alcohol ; 
– Opinion of 16 September 2021 con cerning resorcinol; 1,3 -benzenediol ; 
– Opinion of 16 September 2021 concerning 2,2',6,6' -tetrabromo -4,4'-
isopropylidenediphenol; tetrabromobisphenol -A; 
– Opinion of 16 September 2021 concerning a reassessment at the request of the 
Commission to  review the harm onised classification of lead (environment)  - ;  
– Opinion of 26 November 2021 concerning 2,2'-[[3-methyl -4-[(4-
nitrophenyl)azo]phenyl]imino]bisethanol ; EN 5  EN – Opinion of 26 November 2021 concerning 3,3,4,4,5,5,6,6,7,7,8,8,8 -
tridecafluorooctan -1-ol;  
– Opinion of  26 November 2021 concerning  1,4-Benzenediamine, N,N'-mixed 
Ph and tolyl derivs.; Reaction mass of N-phenyl,N’-o-tolyl-phenylene diamine, 
N,N’ -diphenyl -p-phenylene diamine and N,N’ -di-o-tolyl-phenylene diamine ;  
– Opinion of 26 November 2021 concerning tetrameth ylene dimethacrylate ;  
– Opinion of 26 November 2021 concerning 7,7,9(or 7,9,9) -trimethyl -4,13-
dioxo -3,14-dioxa -5,12-diazahexadecane -1,16-diyl bismethacrylate ;  
– Opinion of 26 November 2021 concerning 2,2'-ethylenedioxydiethyl 
dimethacrylate ;  
– Opinion of 26 N ovember 2021 concerning bifenox (ISO); methyl 5 -(2,4-
dichlorophenoxy) -2-nitrobenzoate ; 
– Opinion of 26 November 2021 concerning  4-methylimidazole ;  
– Opinion of 26 November 2021 concerning sulfur dioxide ;  
– Opinion of 26 November 2021 concerning 1,2-benzisothiazol -3(2H)-one; 1,2 -
benzisothiazolin -3-one; 
– Opinion of 26 November 2021 concerning benalaxyl (ISO); methyl N-(2,6-
dimethylphenyl) -N-(phenylacetyl) -DL-alaninate . 
 
(3) The Commission has received additional information from stakeholders contesting the 
scientific assessment set out in the RAC opinion of 26 November  2021 concerning 
1,4-Benzenediamine, N,N' -mixed Ph and tolyl derivs.  and in the RAC opinion of 16 
September 2021 concerning dibutyltin oxide . The additional information has been 
assessed  and has not been found sufficient to cast doubts on the scientific analysis 
contained in th e RAC opinions. It is therefore appropriate to introduce  the harmonised 
classification and labelling of the substances concerned on the basis of the assessment 
made in those opinions.  
(4) The RAC opinion of 16 September 2021 concerning the environmental toxicity of lead 
put forward various possible options to update the harmonised classification of lead 
for aquatic toxicity. These  options give the possibil ity to either have a single entry for 
both lea d in pow der form  (‘lead powder ’) and in massive form (‘lead massive’) or to 
keep  two separate  entries , one for each  form . However, as data for lead massive 
indicates a lower dissolution in water than for lead powder , a calculation in accord ance 
with Part 4 of Annex I to Regulation (EC) No 1272/2008  leads  to a less s evere  
classification  for lead massive.  It is therefore appropriate to amend the existing aquatic 
toxicity classification for lead pow der with regard to the M -factor and to introduce a 
different aquatic toxicity classification for lead massive . 
(5) In light of the RAC opinions, i t is therefore appropriate to introduce  or update the 
harmonised classification and labelling of the substances concer ned on the basis of the 
assessment made in those opinions  and following the further assessment s. 
(6) Regulation (EC) No 1272/2008 should therefore be amended accordingly.   
(7) As regards the classification of methyl methacrylate as a respiratory sensitiser  and the 
classification of lithium carbonate, lithium chloride and lithium hydroxide  as 
reproductive toxic substances the Commission has received additional information EN 6  EN from stakeholders after obtaining the RAC opinion s of 18 March 2021 and of 16 
September  2021 respectively concerning those substances. Since that new scientific 
information requires further assessment by RAC, methyl methacrylate, lithium 
carbonate, lithium chloride and lithium hydroxide recommended in the RAC opinion s 
should not be subject t o harmonised classification and labelling  at this stage.   
(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 s ubstances 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 allow suppliers sufficient time to 
take the actions required to ensure co ntinuing 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  
 
Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex 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 . 
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 ] 
By way of derogation from Regulation (EC) No 1272/2008 as applicable on … [OP: please 
insert the date = the day before the date of entry into force of this Regulation] , substances and 
mixtures may until … [OP: please insert the date = the last day of the month following 17 
months after the date of entry into force of this Regulation] be classified, labelled and 
packaged in  accordance with  Regulation (EC) No 1272/2008 as amended by  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