EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) 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  
(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,  substances in  
Table 3 of Part 3 of Annex VI , where it finds that the harmonisation of the classification and 
labelling are 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 the parties concerned, 
it is appropriate to introduce, update, delete or leave unchanged the harmonised classification 
and labelling of certain substances  and amend Table 3 of Annex VI to Regulation (EC) No 
1272/2008 accordingly. Moreover , it is  appropriate to amend certain  Notes in Part I of Annex 
VI related to the entries  in Table 3  of Part 3 of Annex VI  for reasons of lega l clarity and 
certainty . 
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 , modified or deleted  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 accou nt by RAC.  
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 10 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 . 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 bases of this delegated act are 
Articles 37(5) and 53(1) of Regulation (EC) No 1272/2008.  
 
                                                 
1 OJ L 123 of 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, l abelling 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 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 and 1999/45/EC, and amending 
Regulation (EC) No 1907/20062, and in particular Article s 37(5) and 53(1) 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 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  (‘Agency’)  
pursuant to Article 37 of Regulati on (EC) No 1272/2008. Based on the opinions3 on 
those proposals issued by the Committee for Risk Assessment of the Agency (RAC), 
as well as on the comments received from the parties concerned, it is appropriate to 
introduce, update  or delete the harmonised  classification and labelling of certain 
substances.  Those RAC opinions are:  
 Opinion of 8 June 2018 concerning nitric acid ... %[C ≤70%]  
 Opinion of 9 March 2018 concerning silicon carbide fibres (with diameter < 3 µm, 
length > 5 µm and aspect ratio ≥ 3:1)  
 Opinion of 8 June 2018 concerning trimethoxyvinylsilane; trimethoxy(vinyl)silane  
 Opinion of 8 June 2018 concerning tris(2 -methoxyethoxy)vinylsilane; 6 -
(2methoxyethoxy) -6-vinyl -2,5,7,10 -tetraoxa -6silaundecane  
 Opinion of 8 June 2018 concerning Dimethyl disul phide  
                                                 
2 OJ L 353, 31.12.2008, p. 1  
3 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/ -/ 
 EN 3  EN  Opinion of 8 June 2018 concerning Granulated copper  
 Opinion of 30 November 2018 concerning bis(N -hydroxy -N-
nitrosocyclohexylaminatoO,O')copper; bis(N -cyclohexyl -diazenium -dioxy)copper; 
[Cu-HDO]  
 Opinion of 14 September 2018 co ncerning dioctyltin dilaurate; [1] stannane, dioctyl -, 
bis(coco acyloxy) derivs. [2]  
 Opinion of 30 November 2018 concerning dibenzo[def,p]chrysene  
 Opinion of 9 March 2018 concerning ipconazole (ISO); 
(1RS,2SR,5RS;1RS,2SR,5SR) -2(4-chlorobenzyl) -5-isopropyl -1-(1H-1,2,4 -triazol1 -
ylmethyl)cyclopentanol  
 Opinion  of 8 June 2018 concerning Bis(2 -(2-methoxyethoxy)ethyl)ether; tetraglyme  
 Opinion of 8 June 2018 concerning paclobutrazol (ISO); (2RS,3RS) -1-(4-
chlorophenyl) -4,4-dimethyl -2- (1H-1,2,4 -triazol -1-yl)pentan -3-ol 
 Opinion of 8 June 2018 concerning 2,2 -bis(bromomethyl)propane -1,3-diol 
 Opinion of 14 September 2018 concerning geraniol; (2E) -3,7-dimethylocta -2,6-dien-
1-ol 
 Opinion of 28 January 2019 concerning 2 -(4-tert-butylbenzyl)propionaldehyde  
 Opinion of 9 March 2018 concerning M CPA -thioethyl (ISO); S -ethyl (4 -chloro -
2methylphenoxy)ethanethioate; S -ethyl 4 -chloroo -tolyloxythioacetate  
 Opinion of 9 March 2018 concerning diisooctyl phthalate  
 Opinion of 14 September 2018 concerning 4 -{[(6-chloropyridin -3-yl)methyl](2,2 -
difluoroethyl) amino}furan -2(5H) -one; flupyradifurone  
 Opinion of 30 November 2018 concerning thiencarbazone -methyl (ISO); methyl 4 - 
[(4,5 -dihydro -3-methoxy -4-methyl -5-oxo-1H1,2,4 -triazol -1-yl)carbonylsulfamoyl] -
5methylthiophene -3-carboxylate    
 Opinion of 9 March 2018 co ncerning L -(+)-lactic acid; (2S) -2-hydroxypropanoic acid  
 Opinion of 9 March 2018 concerning 2 -methoxyethyl acrylate  
 Opinion of 8 June 2018 concerning glyoxylic acid …%  
 Opinion of 14 September 2018 concerning sodium N -(hydroxymethyl)glycinate; 
[formaldehyde  released from sodium  N -(hydroxymethyl)glycinate]  
 Opinion of 30 November 2018 concerning potassium (oxido -NNO -
azoxy)cyclohexane; cyclohexylhydroxydiazene 1 -oxide, potassium salt; [K -HDO]  
 Opinion of 14 September 2018 concerning mecetronium etilsulfate; N -ethyl -
N,Ndimethylhexadecan -1-aminium ethyl sulfate; Mecetronium ethyl sulphate [MES]  
 Opinion of 9 March 2018 concerning (2RS) -2-[4-(4-chlorophenoxy) -
2(trifluoromethyl)phenyl] -1-(1H-1,2,4 -triazol -1yl)propan -2-ol; mefentrifluconazole  
 Opinion of 30 November 2 018 concerning oxathiapiprolin (ISO); 1 -(4-{4-[5-
(2,6difluorophenyl) -4,5-dihydro -1,2-oxazol -3-yl]-1,3thiazol -2-yl}piperidin -1-yl)-2-[5-
methyl -3(trifluoromethyl) -1H-pyrazol -1-yl]ethanone  
 Opinion of 14 September 2018 concerning pyrithione zinc;  (T -4)-bis[1 -(hydroxy -
.kappa.O) pyridine -2(1H) -thionato -.kappa.S]zinc  
 Opinion of 30 November 2018 concerning 3 -chloro -4-(chloromethyl) -1-
[3(trifluoromethyl)phenyl]pyrrolidin -2-one 
 Opinion of 30 November 2018 concerning 4,5 -dichloro -2-octyl -2H-isothiazol -3-one; 
[DCOIT]  
 Opinion of 8 June 2018 concerning 2 -methyl -1,2-benzothiazol -3(2H) -one; [MBIT]  
 Opinion of 30 November 2018 concerning 3 -(difluoromethyl) -1-methyl -N-
(3',4',5'trifluorobiphenyl -2-yl)pyrazole -4-carboxamide; fluxapyroxad  EN 4  EN  Opinion of 8 June 2018 concerning 3 -(difluoromethyl) -1-methyl -N-
(3',4',5'trifluorobiphenyl -2-yl)pyrazole -4-carboxamide; fluxapyroxad  
 Opinion of 15 October 2018 concerning 5 -fluoro -1,3-dimethyl -N-[2-(4-methylpentan -
2yl)phenyl] -1H-pyrazole -4-carboxamide; 2’ -[(RS)1,3 -dimethylbutyl] -5-fluoro -
1,3dimethylpyrazole -4-carboxanilide; penflufen  
 Opinion of 30 November 2018 concerning 5 -fluoro -1,3-dimethyl -N-[2-(4-
methylpentan -2yl)phenyl] -1H-pyrazole -4-carboxamide; 2’ -[(RS)1,3 -dimethylbutyl] -5-
fluoro -1,3dimethylpyrazole -4-carboxanilide; penflufen  
 Opinion of 30 November 2018 concerning silthiofam (ISO); N -allyl-4,5-dimethyl -
2(trimethylsilyl)thiophene -3-carboxamide  
 Opinion of 9 March 2018 concerning Margosa, ext. [cold -pressed oil of Azadirachta 
indica seeds without shells extracted with supercritica l carbon dioxide]  
 Opinion of 8 June 2018 concerning nitric acid …%[C> 70%]  
 Opinion of 9 March 2018 concerning Octamethylcyclotetrasiloxane; [D4]  
 Opinion of 30 November 2018 concerning pirimiphos -methyl (ISO); O -[2-
(diethylamino) -6methylpyrimidin -4-yl] O,O -dimethyl phosphorothioate  
 Opinion of 30 November 2018 concerning phosphine  
 Opinion of 14 September 2018 concerning dichlorodioctylstannane  
 Opinion of 30 November 2018 concerning 2 -ethylhexyl 10 -ethyl -4,4-dioctyl -7-oxo-8-
oxa3,5 -dithia -4-stannatetradecanoate ; [DOTE]  
 Opinion of 30 November 2018 concerning lead powder; [particle diameter < 1mm]  
 Opinion of 30 November 2018 concerning lead massive; [particle diameter ≥ 1mm]  
 Opinion of 14 September 2018 concerning 2 -butoxyethanol; ethylene glycol 
monobutyl ether  
 Opinion of 30 November 2018 concerning m -bis(2,3 -epoxypropoxy)benzene; 
resorcinol diglycidyl ether  
 Opinion of 14 September 2018 concerning citral; 3,7 -dimethylocta -2,6-dienal  
 Opinion of 14 September 2018 concerning tribenuron -methyl (ISO); methyl 2 - [N-(4-
methoxy -6-methyl -1,3,5 -triazin -2-yl)-Nmethylcarbamoylsulfamoyl]benzoate  
 Opinion of 8 June 2018 concerning azoxystrobin (ISO); methyl (E) -2-{2-[6-
(2cyanophenoxy)pyrimidin -4-yloxy]phenyl} -3methoxyacrylate  
 Opinion of 9 March 2018 concerning ethofumesate (ISO);  (RS) -2-ethoxy -2,3-
dihydro3,3 -dimethylbenzofuran -5-yl methanesulfonate  
 Opinion of 30 November 2018 concerning 2,4 -dinitrophenol  
 Opinion of 14 September 2018 concerning mesotrione (ISO) 2 -[4-(methylsulfonyl) -
2nitrobenzoyl] -1,3-cyclohexanedione  
 Opinion of 30  November 2018 concerning octhilinone (ISO); 2 -octyl -2H-isothiazol -3-
one; [OIT]  
 Opinion of 14 September 2018 concerning hymexazol (ISO); 3 -hydroxy -5-
methylisoxazole  
 Opinion of 30 November 2018 concerning hexythiazox (ISO); trans -5-(4-
chlorophenyl) -Ncyclohe xyl-4-methyl -2-oxo-3-thiazolidine -carboxamide  
 Opinion of 9 March 2018 concerning pymetrozine (ISO); (E) -4,5-dihydro -6-methyl -4-
(3-pyridylmethylene amino) -1,2,4 -triazin -3(2H) -one 
 Opinion of 9 March 2018 concerning imiprothrin (ISO); reaction mass of: [2,4 -
dioxo(2 -propyn -1-yl)imidazolidin -3-yl]methyl(1R) -cischrysanthemate; [2,4 -dioxo -(2-
propyn -1yl)imidazolidin -3-yl]methyl(1R) -transchrysanthemate  
 Opinion of 14 September 2018 concerning butanone oxime; ethyl methyl ketoxime;  
ethyl methyl ketone oxime  EN 5  EN  Opinion o f 8 June 2018 concerning bis(α,α -dimethylbenzyl) peroxide  
 Opinion of 9 March 2018 concerning branched hexatriacontane  
 Opinion of 30 November 2018 concerning hexyl 2 -(1-(diethylaminohydroxyphenyl) 
methanoyl)benzoate;  hexyl 2 -[4-(diethylamino) -2-hydroxybenz oyl]benzoate  
(3) It is appropriate and scientifically justified to follow the RAC opinions regarding the 
hazard classes proposed for the harmonised classification and labelling of certain 
substances.  
(4) It is appropriate to update  specific  Notes in Part I of Annex VI relating to the 
identification, classification and labelling of substances , for reasons of legal clarity and 
certainty . 
(5) Regulation (EC) No 1272/2008 should therefore be amended accordingly.  
(6) To ensure that suppliers of substance s and mixtures have time to adapt to the new 
harmonised classification and labelling provisions  in Table 3 of Part 3 of Annex VI to 
Regulation (EC) No 1272/ 2008 , a transitional period of 18 months should be provided 
during which suppliers may choose whether or not to apply those provisions .. 
 
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 ap plication  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
 Until 18 months from the date of entry into force of this Regulation, substances and mixtures 
are not re quired to be classified, labelled and packaged in accordance with 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  
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