EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) 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) 2017/776  
(Text with EEA relevance)    
EN 2   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) 2017/776  
(Text with EEA relevance)  
THE EUROP EAN 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 1907/20061, and in particular Article 37(5)  and Article 53(1)  thereof ,  
Whereas:  
(1) Table 3 .1 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 classifi cation 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 appropriate to introduce, 
update or delete harmonised classification and labelling of ce rtain substances.   
(3) Council Directive 67/548/EEC2 and Directive 1999/45/EC  of the European Parliament 
and of the Council3 were repealed with effect from  1 June 2015. As a result, Part 3 of 
Annex VI to Regulation  (EC) No 1272/2008  was amended by Commission Regulation 
(EU) 2016/11794 to remove Table 3.2. That amendment took effect on 1 June 2017. 
Annex VI to Regulation (EC) No 1272/2008  was further amended by Commission 
                                                 
1 OJ L 353, 31.12.2008, p.1.  
2 Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and 
administrative provisions relating to the classification, packaging and labelling of dangerous substances 
(OJ L 196, 16.8.1967, p. 1).  
3 Directive  1999/45/EC of the European Parliament and  of the Council of 31 May 1999 concerning the 
approximation of laws, regulations and administrative provisions of the Member States relating to the 
classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p.1).  
4 Commission Regulation (EU) 201 6/1179  of 19 July 2016 amend ing, 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 195 20.7.2016, 
p.11.  
EN 3   EN Regulation (EU) 2017/7765 to delete references to Table 3.2 , to convert references to 
Table 3.1 into references to Table 3 and to delete references to the repealed Directives . 
Under Article 2(2) of Regulation (EU) 2017/776 , the majority of those amendments 
were to apply from 1 Ju ne 2017 , while th e remaining  amendments  were stated to apply 
from 1 December 2018. However, due to an oversight  Article 2(2) failed to list two 
further amendments that should have applied from 1 June 2017 , including in particular 
the amendment changing the name of the Table from "Table 3.1" to "Table 3" . The 
second subparagraph of Article 2(2) of Regulation (EU) 2017/776 should therefore be 
corrected to include  reference to  those t wo amendments. This correction , although it 
has the effect of applying the t wo amendments retroactively,  does not affect the rights 
and obligations of  manufacturers, importers, downstream users or suppliers.  
(4) Regulation (EU) 2017/776 also amended Annex VI to Regulation  (EC) No 1272/2008 
to add harmonised 'Acute Toxicity Estimate' (ATE) values in Table 3 .1 as part of the  
information relat ing to the clas sification and labelling of certain substances for the 
purposes of  the classification of mixtures . The ATE introduced for nicotine was 
expressed in mg/kg. In order to clarify how mixtures contain ing nicotine should be 
class ified, the ATE for nicotine should instead be expressed in 'mg/kg bw'6. Three 
other substances with ATEs , namely  colecalciferol, 1,2-dihydroxybenzene  and 
pinoxaden  should also be expressed in the same way.  In addition, in the title of the 
penultimate column of Table 3 .1, a footnote should be add ed indicating what the 
abbreviation 'mg/kg bw' stands for.  
(5) The Annex  to Commission Regulation (EU) XX/20177 [OP: please insert number of 
the Regulation here and reference it in the footnote ] provides for the translation of the 
names of the substances included in Table 3 .1 of Annex VI to Regulation  (EC) No 
1272/2008 . As a consequence, the title of the second column of that Table, which 
currently refers to 'international chemical identifications ', should be amen ded to take 
account of the fact that the 'international chemical identifications ' will lose their 
international character once the Regulation providing for their translation  in Annex VI  
becomes applicable . For the sake of consistency, t his amendment should  take effect 
when the translation of th e names in Annex VI takes effect . The new title should 
reflect the terminology used in Article 18 of Regulation  (EC) No 1272/2008 . 
(6) Compliance with the new or updated harmonised classifications should not be required 
immediately as a certain period of time will be 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. That period of time will also be necessary to 
allow suppliers  to adapt to and comply with other legislative obligations resulting from 
the new or updated harmonised classifications, such as those set out in Article 22(f) or 
Article 23 of Regulation (EC) No 1907/2006 of the European Parliament and of the  
Council8, those set out in Article 50 of Regulation (EU) No 528/2012 of the European 
                                                 
5 Commission Regulation (EU) 2017/776 of 4 May 2017 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 su bstances and mixtures (OJ L 116 5.5.2017, p.  1). 
6 Body weight  
7 Commission Regulation (EU) XX/201 X amending, for the purposes of its adaptation to technical and 
scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Counci l on 
classification, labelling and packaging of substances and mixtures  [OP: please insert reference of this 
future Commission Regulation  here it should be adopted in the first quarter of 2018 and concerns the 
translation of the names of the chemical subst ances into the official languages of the EU ] 
8 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) .  
EN 4   EN Parliament and of the Council9 or those set out in Article 44 of Regulation (EC) No 
1107/2009 of the European Parliament and of the Council10.  
(7) Regulation (EC) No 1272/200 8 should therefore be amended accordingly.   
(8) In line with the transitional provisions of Regulation (EC) No 1272/2008 which allow 
for new provisions to be applied at an earlier stage on a voluntary basis, suppliers  
should be allowed to apply the new and upd ated harmonised classifications , and to 
adapt the labelling and packaging accordingly , on a voluntary basis before the date of 
application of those new or updated classifications . 
(9) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established by Article 133 of Regulation (EC) No 1907/2006 ,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Amendment to Regulation (EC) No 1272/2008  
Annex VI to Regulation (EC) No 1272/2008 is amended as set out in  the Annex to this 
Regul ation . 
Article 2 
Correction to Regulation (EU) 2017/776  
In Regulation (EU) 2017/776 , the second subparagraph of Article 2(2) is replaced by the 
following : 
"In the Annex, point (1), point (2)  and point s (a), (b) and (c)  of point (3)  shall apply from 1 
June 2017."  
 
Article 3 
Entry into force 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 . 
Point (1) and point ( a) of point (2) of the Annex shall apply  from [ OP: please insert date to be 
determined as follows: Date of application of Regulation XX  – see also recital 5 ].  
Points (b), (c), (d) and (e) of point (2) of the Annex 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. ]  
                                                                                                                                                         
establishing a Europe an 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).  
9 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 ). 
10 Regulation (EC) No 1107/2009  of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).   
EN 5   EN By way of derogation from the third  paragraph  of this Article , substances and mixtures may, 
before [ OP: please insert specific date of application determined under the third paragraph ], 
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 St ates. 
Done at Brussels,  
 For the Commission  
 The President  
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