EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending, for the purposes of its adaptation to technical and scientific progress, Part 3 
of Annex VI to 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 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 
States  and stakeholders , it is appropriate to introduce, update or delete 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 performe d a 
public consultation for each substance to be included  in, modified or deleted  from 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 Asses sment  (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 r elevant 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  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 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, Part 3 
of Annex VI to 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 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 repeali ng Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/20062, 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 labelli ng 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 labellin g of certain other 
substances have been submitted to the European Chemicals Agency  (‘Agency’)  
pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk 
Assessment of the Agency (RAC)  adopted opinions3 on those proposals , after having 
taken account of the  comments received from the parties concerned . Those RAC 
opinions are:  
 
– Opinion of 15 March 2019 concerning 1,2,4 -triazole ; 
– Opinion of 15 March 2019 concerning 1,4-dioxane ; 
– Opinion of 15 March 2019 concerning b enzyl salicylate ; 
– Opinion of 15 March 2019 concerning flumioxazin (ISO) ; 
– Opinion of 15 March 2019 concerning mancozeb (ISO) ; 
– Opinion of 15 March 2019 concerning M -factors for long -term aquatic hazard 
for the copper substances listed in Commission Regulation (EU) 2016/1179 ; 
                                                 
2 OJ L 353, 31.12.2008, p. 1  
3 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/ -/  EN 3  EN – Opinion of 15 March 2019 concerning  N-{2-[[1,1' -bi(cyclopropyl)] -2-
yl]phenyl} -3-(difluoromethyl) -1-methyl -1H-pyrazole -4-carboxamide; 
sedaxane ; 
– Opinion of 15 March 2019 concerning N-methoxy -N-[1-methyl -2-(2,4,6 -
trichlorophenyl) -ethyl] -3-(difluoromethyl) -1-methylpyrazole -4-carboxamide; 
pydiflumetofen ; 
– Opinion of 15 March 2019 concerning p-cymene; 1 -isopropyl -4-
methylbenzene ; 
– Opinion of 15 March 2019 concerning p-mentha -1,3-diene; alpha -terpinene; 1 -
isopropyl -4-methylcyclohexa -1,3-diene ; 
– Opinion of 15 March 20 19 concerning p rothioconazole ; 
– Opinion of 15 March 2019 concerning (R)-p-mentha -1,8-diene ;d-limonene;  
– Opinion of 15 March 2019 concerning thiophanate -methyl;  
– Opinion of 15 March 2019 concerning tolclofos -methyl (ISO); O-(2,6- 
 dichloro -p-tolyl) O,O-dimethy l thiophosphate;  
– Opini on of 15 March 2019 concerning t olpyralate;  
– Opinion of 15 March 2019 concerning trinickel d isulphide;  
– Opinion of 13 June 2019 concerning a zamethiphos ; 
– Opinion of 13 June 2019 concerning 2-phenoxyethanol ; 
– Opinion of 13 June 2019 concerning 2,2-dibromo -2-cyanoacetamide;  
– Opinion of 13 June 2019 concerning 3-aminomethyl -3,5,5 -
trimethylcyclohexylamine ; 
– Opinion of 13 June 2019 concerning 6,6' -di-tert-butyl-2,2'-methylenedi -p-
cresol ; 
– Opinion of 13 June 2019 conce rning diflufenican (ISO) N-(2,4-
difluorophenyl) -2-[3-(trifluoromethyl)phenoxy] -3-pyridinecarboxamide ; 
– Opinion of 13 June 2019 concerning imidacloprid (ISO); 1 -(6-chloropyridin -3-
ylmethyl) -N-nitroimidazolidin -2-ylidenamine ; 
– Opinion of 13 June 2019 concernin g pyriofenone ; 
– Opinion of 13 June  2019 concerning S-abscisic acid ; 
– Opinion of 13 June 2019 concerning tetrakis(2,6 -dimethylphenyl) -m-
phenylene biphosphate . 
– Opinion of 20 September 2019 concerning 1,2 -epoxy -4-
epoxyethylcyclohexane ; 
– Opinion of 20 September 2019 concerning 4-methylpentan -2-one; 
– Opinion of 20 September 2019 concerning boric acid; diboron trioxide; 
tetraboron dis odium heptaoxide hydrate; d isodi um tetraborate anhydrous; 
orthoboric acid sodium salt; d isodium tetraborate de cahydrate ; disodium 
tetraborate pentahydrate ; 
– Opinion of 20 September 2019 concerning citric acid;  EN 4  EN – Opinion of 20 September 2019 concerning c lomazone ; 
– Opinion of 20 September 2019 concerning d esmedipham ; 
– Opinion of 20 September 2019 concerning dimethomorph ; 
– Opinion of 20 September 2019 concerning e mamectin  benzoate;  
– Opinion of 20 September 2019 concerning esfenvalerate (ISO) ( S)-a-cyano -3-
phenoxybenzyl -(S)-2-(4-chlorophenyl) -3-methylbutyrate ; 
– Opinion of 20 September 2019 concerning ethametsulfuron -methyl (IS O); 
– Opinion of 20 September 2019 concerning mecoprop -P (ISO); ( R)-2-(4-chloro -
2-methylphenoxy)propionic acid  and its salts;  
– Opinion of 20 September 2019 concerning methyl salicylate ; 
– Opinion of 20 September 2019 concerning phenmedipham (ISO) ; 
– Opinion of 20  September 2019 concerning trifloxystrobin (ISO);  
– Opinion of 20 September 2019 concerning triticonazole;  
– Opinion of 5 December 2019 concerning 1,4-dimethylnaphthalene ; 
– Opinion of 5 December 2019 concerning 
(3aS,5S,6R,7aR,7bS,9aS,10R,12aS,12bS)-10-[(2S,3R,4R,5R)-3,4-dihydroxy -
5,6-dimethylheptan -2-yl]-5,6-dihydroxy -7a,9a -dimethylhexadecahydro -3H-
benzo[c]indeno[5,4 -e]oxepin-3-one; 24 -epibrassinolide;  
– Opinion of 5 December 2019 concerning 3-methylpyrazole ; 
– Opinion of 5 December 2019 concerning carbendazim (ISO) ; methyl 
benzimidazol -2-ylcarbamate ; 
– Opinion of 5 December 2019 concerning cypermethrin cis/trans +/ - 40/ 60; 
(RS)-á-cyano -3-phenoxybenzyl (1 RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl) -2,2-
dimethylcyclopropanecarboxylate ; 
– Opinion of 5 December 2019 concerning imazamox (ISO); ( RS)-2-(4-
isopropyl -4-methyl -5-oxo-2-imidazolin -2-yl)-5-methoxymethylnicotinic acid ; 
– Opinion  of 5 December 2019 concerning t etrafluoroethylene;  
– Opinion of 5 December 2019 concern ing t hiamethoxam (ISO); 3 -(2-chloro -
thiazol -5-ylmethyl) -5-methyl [1,3,5]oxadiazinan -4-ylidene -N-nitroamine;  
– Opinion of 5 December 2019 concerning trinexapac -ethyl (ISO); ethyl 4 -
[cyclopropyl(hydroxy)methylene] -3,5-dioxocyclohexanecarboxylate;  
 
(3) Acute Toxicity Estimates (ATE) are mainly used to determine the classification for 
human health acute toxicity of mixtures containing substances classified for acute 
toxicity. The inclusion of harmonised ATE values in the entries listed in Annex VI to 
Regu lation (EC) No 1272/2008 facilitates the harmonisation of the classification of 
mixtures and provides support for enforcement authorities. Following further scientific 
assessmentsof some substances, ATE values have been derived by the Agency for 
dicopper o xide, dicopper chloride trihydroxide, tetracopper hexahydroxide sulphate  
and tetracopper hexahydroxide sulphate hydrate , copper flakes (coated with aliphatic 
acid) , copper(II) carbonate --copper(II) hydroxide (1:1) , copper dihydroxide; copper(II) EN 5  EN hydroxide,   bordeaux mixture;  reaction products of copper sulphate with calcium 
dihydroxide  and copper sulphate pentahydrate ,  in addition to those proposed in the 
RAC opinions  for other substances . Those ATE values should be inserted in the 
penultimate column of Ta ble 3 of Part 3 of Annex VI to Regulation (EC) No 
1272/2008.  
(4) Additional information was received by the Commission contesting the scientific 
assessment set out in the RAC opinions of 15 March 2019 concerning mancozeb, of  
20 September 2019 concerning  4-meth ylpentan -2-one, and of  20 September 2019 
concerning dimethomorph . That information was assessed by the Commission and 
was not found sufficient  to  cast doubt s on the  scientific analysis contained in the  
RAC  opinion s.  
(5) The Commission therefore considers appropriate to introduce, update or delete the 
harmonised classification and labelling of certain substances.  
(6) Regulation (EC) No 1272/2008 should therefore be amended accordingly.  
(7) Compliance with the new or updated harmo nised 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 revised 
classifications and to sell existing stocks  subject t o 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 following the changes made under this Regulation . Such requirements 
may include those set out in point (f) of Article 22 (1) of Regulation (EC) No 
1907/2006 of the European Parliament and of the Council4 or those set out in Article 
50 of Regulation (EU) No 528/2012 of the European Parliament and of the Council5. 
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  and as of the dat e of 
entry into force  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  
Table 3 of Part 3 of  Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the 
Annex to this Regulation .  
                                                 
4 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006  
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1).  
5 Regulation (EU) No  528/2012 of the European Parliament and of the Council of 22  May 2012  
concerning the making available on the market and use of biocidal products  
(OJ L 167, 27.6.2012, p. 1).  EN 6  EN 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 Journa l 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 seco nd 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  
 Ursula von der Leyen