EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
correcting 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  
 
CONTEXT  OF THE  DELEGATED  ACT  
The Commission has become aware of errors due to an oversight in Annex III to Commission 
Delegated Regulation (EU)  2020/2171. It concerns a signal word that needs to be put on the labels 
of some hazardous substances and, as the case may be , mixtures containing those substances. 
Labelling requirements such as signal words are linked to a specif ic hazard class  as provided  in 
Annex I to the Regulation (EU) No 1272/20082 (the CLP Regulation). Annex III of Commission  
Delegated Regulation (EU) 2020 /2017 erroneously contains the signal word ‘Dgr’ (danger) instead  
of ‘Wng’ (warning) for three  substances  (pentapotassium 2,2’,2’’,2’’’,2’’’’(ethane -1,2-
diylnitrilo)pentaacetate ; N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid) and 
pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate  (DTPA) ). Those substances  
are classified , inter al ia, as specific target organ toxicant – repeated exposure (category 2) , and 
should therefore contain the signal word ‘Wng’  instead of the signal word ‘Dgr’ that indicates a 
more severe hazard.  This error should be corrected.  
In order not  to penalise producers, importers or downstream users who would already have labelled 
and packaged their substances or mixtures in accordance with Regulation (EU) 2020/217 before the 
entry into force of this regulation, they should be allowed not to relabel a nd repackage them in 
accordance with this regulation.  
CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Pursuant to Article 53a(4) of Regulation (EU) No 1272/2008, experts designated by each Member 
State in the expert group CARACAL (Competent authorities for REACH and CLP) have been  
consulted. Furthermore, the draft Commission Delegated Regulation has been transmitted to the 
European Parliament and the Council  which are invited to participate in the CARACAL expert 
group meetings i n accordance with point 10 of the Annex to the Interinstitutional Agreement 
between the European Parliament, the Council of the European Union and the European 
Commission on Better Law -Making of 13 April 20163. 
Stakeholders were consulted in the CARACAL expert group in accordance with point 6 of the 
Annex to the Interinstitutional Agreement on Better Law -Making of 13 April 20164. 
LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal act corrects an error made due to an oversight in Commission Regulation (EU) 2020/217, 
which had previously amend ed Regulation (EC) No 1272/2008.  
                                                 
 
1 Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 amending, for the purposes of its 
adap tation 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 and correcting that  
Regulation  (OJ L 44, 18.1.2020,  p.1). 
2 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 1907/2006  (OJ L 353, 31.12.2008, p.1. ) 
3 OJ L 123 , 12.05 2016, p. 1.  
4 OJ L 123, 12.05.2016, p.1.  EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
correcting 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 Parlia ment 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 
1907/20061, and in particular Article 37(5) thereof, 
 
Whereas:  
(1) Verification has revealed errors in Annex  VI to Regulation (EC) No 1272/2008. 
Commission Delegated Regulation (EU) 2020/2172, which amended that Annex, added a 
number of substances in T able 3  of Part 3 thereof . The  entries concerning  the sub stances  
pentapotassium 2,2’,2’’,2’’’,2’’’’(etha ne-1,2-diylnitrilo)pentaacetate , N-
carboxymethyliminobis(ethylenenitrilo)tetra  (acetic acid)  and pentasodium 
(carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate  contain errors re lated to  the signal 
word . Those substances are classified, inter alia, as specific target organ toxicant repeated 
exposure category 2 and should therefore  be labelled by using  the signal word ‘Wng’  (an 
abbreviation of ‘Warning’)  in accordance with Table 3.9.5. of Part 3 of Annex I to 
Regulation (EC) No 1272/2008 . Delegated Regulation (EU) 2020/217  however  mistakenly 
introduced the  signal word ‘Dgr’  (an abbreviation of ‘Danger’)  for those substances.  Those 
error s should  be corrected.  
(2) Regulation (EC) No 1272/2008 should the refore be c orrected accordingly.  
(3) As the provisions of Delegated Regulation (EU) 2020/217 containing the mistake apply 
from 1 October 2021 , the correction thereof should also apply from that date.  
(4) Similarly, in order to reflect  the provisions of Delegated Regulation ( EU) 2020/217, 
suppliers should be allowed to apply the corrections made by this Regulation to substances 
and mixtures before its date of application  on a voluntary basis . 
(5) Suppliers should not be required to change  the label s and package s of substances and 
mixtures which have been placed  on the market before the entry into force of this Regulation 
                                                 
 
1 OJ L 353, 31.12.2008, p.1.  
2 Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 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 and correcting that 
Regulation (OJ L 44, 18.1.2020, p.1).  EN 3  EN in accordance with Regulation (EC) No 1272/2008 , to avoid unnecessary costs . As the 
erroneous signal word corresponds to a more sev ere hazard class , maintaining that signal 
word on the label does not decrease the level of protection of  human health . 
 
HAS ADOPTED THIS REGULATION:  
Article 1  
The signal word ‘Dgr’ in the seventh column ‘ Pictogram, Signal Word Code(s) ’ of Table 3 i n Part 3 
of Annex VI to  Regulation (EC) No 1272/2008  regarding  the entries  concerning  pentapotassium 
2,2’,2’’,2’’’,2’’’’(etha ne-1,2-diylnitrilo)pentaacetate, N-carboxymethyliminobis(ethylenenitri 
lo)tetra  (acetic acid)  and pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo) tetraacetate  is 
replaced by the signal word  ‘Wng’ . 
Article 2 
Suppliers shall not be required to change , as indicated  in Article 1 , the label or  the packag ing of 
substances or mixtures containing them, which  they have placed on the market in accordance with 
Regulation (EC) No 1272/2008 before … [OJ: please insert the date – the date of entry into force of 
this amending Regulation ].  
Article 3 
This Regulation shall enter into force on the third day following that of its publication in the Official 
Journal of the European Union.  
It shall apply from 1 October 2021 .  
By way of derogation from the second paragraph of this Article, t he substances ref erred to in Article 
1 of this Regulation and the substances and mixtures containing them may, before 1 October 2021, 
be classified, labelled and packaged  in accordance  with Regulation (EC) No 1272/2008 as corrected 
by this Regulation.  
 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 Ursula VON DER LEYEN  
 The President