EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
 
COMMISSION 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 and correcting 
Commission Re gulation (EU) 2018/669  
(Text with EEA relevance)   EN 1  EN COMMISSION 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 and correcting 
Commission Regulation (EU) 2018/669  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Fu nctioning 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 1907/20061, and in particular Article s 37(5) and 53(1) thereof,  
Whereas:   
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.  
(1) Proposals to introduce harmonised class ification 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 pursuant to 
Article 37 of Regulation (EC) No 1272/2008. Based  on the opinions 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 appr opriate to introduce, 
update, delete  or leave unchanged  harmonised classification  and labelling of certain 
substances.  
(2) It is appropriate and scientifically justified to follow RAC’s opinions regarding the 
hazard classes proposed for the harmonised classification and labelling of certain 
substances.  
(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 
Regulation (EC) No 1272/2008 facilitate  the harmonisation of the classification of 
mixtures and provide support for enforcement authorities. F ollowing further scientific 
assessments on some substances , ATE  values have been calculated and should be 
inserted in the penultimate column of Table 3  of Part 3 of Annex VI to Regulation 
1272/2008. T he substances  concerned are  methylmercuric chloride, pentapotassium 
2,2’,2’’,2’’’,2’’’’ -(ethane -1,2-diylnitri lo)pentaacetate , N-
carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid), pentasodium 
                                                 
1 OJ L 353, 31.12.2008, p.1.  EN 2  EN (carboxylat omethyl)iminobis(ethylenenitrilo)tetraacetate, ethylene oxide; oxirane and 
metaldehyde (ISO); 2,4,6,8 -tetramethyl -1,3,5,7 -tetraoxacyclooctane . 
(4) In its scientific opinion of 22 September 2017 on the substance cobalt, RAC propose d 
to classify that substance as carcinogen category 1A with a specific concentration limit 
of ≥ 0,01 %. However, the methodology  used to determine a specific concentration 
limit required further assessment in particular of its applicability to metal compounds . 
It is therefore appropri ate not to introduce , for the time being, any spe cific 
conc entration limit  in Table 3  of Part 3 of Annex VI to Regulation (EC) No 1272/2008  
for cobalt , in which case the general concentration limit of ≥ 0,1 % should apply, in 
accord ance with  Table 3.6.2 of  Annex I to that Regulation.  
(5) In its scientific opinion of 14 September 2017 on the substance titanium dioxide , RAC 
proposed to classify that substance  as carcinogen category 2  by inhalation . As titanium 
dioxide  induced -lung carcinogenicity is associated with inhalation of respirable 
titanium dioxide particles , it is appropriate to define respirable titanium dioxide 
particles in the titanium dioxide entry. In addition, as some dangerous dust or droplet s 
could be formed  during the use of mixtures containing titanium dioxide , it is necessary 
to inform the users on the precautionary measure s that need to be taken  to minimi se 
the hazard for human health .  
(6) Regulation (EC) No 1272/2008 should therefore be amended accordingly.  
(7) Commission Regulation (EU) 2018/6692 provides for the translation of chemical 
names into all official languages of the Union, except Irish . Regulation (EU) 2018/669 
contains the harmonised classification, labelling and packaging for the substance pitch, 
coal tar, high temp. as applicable on 1 January 2016. However,  Commission 
Regulation (EU) No 944/20133 amended the harmonise d classification, labelling  and 
packaging  of that substance as from 1 April 2016. Due to an administrative oversight, 
Regulation (EU) 2018/669 did not take into account the amendments introduced with 
Regulation (EU) No 944/2013.  As Regulation (EU) 2018/669 will become applicable 
as of 1 December 2019, it will erroneously  re-introduce the original classification, 
labelling and packaging for the entry pitch , coal tar , high temp . Regulation (EU) 
2018/669  should  therefore  be correct ed accordingly .   
(8) To ensure that suppliers of substances and mixtures have time to adapt to the  new 
classification and labelling provisions, the application of this Regulation should be 
deferred.  
(9) In line with the trans itional provisions of Regulation (EC) No 1272/2008 which allow 
the application of the new provisions at an earlier stage on a volunt ary basis, suppliers 
should have the possibility of appl ying the new classification, labelling and packaging 
provisions on a voluntary basis before the date of application of this Regulation.  
                                                 
2 Commission Regulation (EU) 2018/669 of 16 April 2018 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  (OJ L 115, 4.5.2018, 
p. 1).  
3 Commission Regulation (EU) No 944/2013 of 2 October 2013 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  (OJ 
L 261, 3.10.2013, p. 5 ). EN 3  EN (10) The measures provided for in this Regulation are in accordance w ith the opinion of the 
Committee established by Article 133 o f Regulation (EC) No 1907/2006  of the 
European Parliament and of the Council4, 
 
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendment s to Regulation (EC) No 1272/2008  
 
Regulation (EC) No 1272/2008 is amended as follows:  
(1) Annex II is amended as set out in Annex  I to this Regulation.  
(2) Annex III is amended as set out in Annex II to this Regulation.  
(3) Annex VI is amended as set out in Annex III to this Regulation.  
 Article 2  
Correction to Regulat ion (EU) 2018/669  
The Annex to Commission Regulation (EU) 2018/669 is corrected as set out in Annex IV to 
this Regulation.  
Article 3  
Entry into fo rce 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 [OP: please insert date to be determined as follows: Date of entry into 
force plus 18 months – the date should be the 1st day of the following month.]  
Article 2 shall apply from  1 December 2019 .  
By way of derogation from the second  parag raph, substances and mixtures may, before [ OP: 
please insert specific date of application determined under the second  paragraph ], be 
classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as 
amended by this Regulation.  
This Regul ation shall be binding in its entirety and directly applicable in all Member States.  
                                                 
4 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Aut horisation 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, 93/105/EC and 2000/21/EC (OJ L 396, 
30.12.2006, p.1).  EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
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