EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) 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  
(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  
(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 classif ication, 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) Table 3.1  of Part 3 of Annex VI to Regul ation (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 for new, updated or deleted harmonised classification and l abelling of 
certain substances have been submitted to the European Chemicals Agency (ECHA) 
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 ECHA (RAC), as 
well a s on the comments received from the parties concerned, it is appropriate to 
introduce, update or delete harmonised classification and labelling of certain 
substances.  
(3) The Acute Toxicity Estimates (ATE) are mainly used to determine the classification 
for hu man 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 w ould facilitate the harmonisation of the classification 
of mixtures and provide support for enforcement authorities. The ATE values 
harmonised in accordance with Article 37 should be added in the penultimate column 
of Table 3.1  of Part 3 of  Annex VI to  that Regulation . Pursuant to  Article 38(1)(e)  
those values are to be mentioned in the opinions and decisions for harmonised 
classification.  The title of the column  of Table 3.1 of Part 3  as well as section 1.1.2.3 
of Part 1 of Annex VI to Regulation (EC) No 1272/2008  should be amended 
consequently.  
(4) Compliance with th e new harmonised classifications and the new provision on the 
ATE  in section 1.1.2.3 of Part 1 of Annex VI to Regulation (EC) No 1272/2008  should 
not be required immediately, as a certain period of time will be necessary to allow 
suppliers to adapt the lab elling and packaging of substances and mixtures to the new 
classifications and to sell existing stocks. That period of time will also be necessary to 
                                                 
1 OJ L 353, 31.12.2008, p.1.  EN 3   EN allow suppliers to adapt to and to comply with other legislative obligations resulting 
from the new harmon ised classifications for substances 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 Council2, those set out  in Article 50 of Regulation (EU) No 528/2012 of the 
European Parliament a nd of the Council3 or those  set out  in Article 44 of Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council4.  
(5) Table 3.2 of Annex VI to Regulation  (EC) No  1272/2008 , which lists the  harmonised 
classification and labelling of hazardous s ubstances based on the criteria set out in  
Coun cil Directive 67/548/EEC5, has been deleted with effect from  1 June 2017. For 
reasons of consistency , the references to Table 3.2 in Part s 1 and 3 of Annex VI to 
Regulation (EC) No 1272/2008 should be deleted with effect from  the same date . For 
reasons of clarity, Table 3.1 of Annex  VI to Regulation (EC) No 1272/2008  should 
become Table 3 and all references to Table 3.1 in that Annex should be changed 
accordingly.  
(6) Directive 67/548/EEC and Directive 1999/45/EC  of the European Parliament and  of 
the Council6 have been repealed with effect from  1 June 2015. For reasons of 
consistency, t he references to those Directives in the introductory part and in Part s 1 
and 3 of Annex VI to Regulation (EC) No 1272/2008 should b e deleted 
simultaneously with the changes regarding the references to Table s 3.1 and 3.2 of 
Annex VI  to that Regulation  with effect from  1 June 2017 , which is the date provided 
for in Article 61(4) of Regulation (EC) No 1272/2008 before which mixtures whic h 
are classified, labelled and packaged in accordance with Directive 1999/45/EC and 
placed on the market before 1 June 2015 need not to be relabelled and repackaged in 
accordance with Regulation (EC) No 1272/2008 . 
(7) Regulation (EC) No 1272 /2008 should be ame nded accordingly.   
(8) In line with the transitional provisions of Regulation (EC) No 1272/2008 which allow 
the application of the new provisions at an earlier stage on a voluntary basis, suppliers 
should have the possibility of applying the new harmonised cla ssifications and of 
adapting the labelling and packaging accordingly on a voluntary basis before the 
deadline for compliance.  
(9) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established by Article 133 of Reg ulation (EC) No 1907/2006,  
                                                 
2 Regulation (EC) No  1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restr iction 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 Directive s 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC  (OJ L 396, 30.12.2006, p. 1 ).  
3 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 ). 
4 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, 24.1 1.2009, p. 1 ). 
5 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).  
6 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 ). EN 4   EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex VI to Regulation (EC) No 1272/2008 is amended as set out in  the Annex to this 
Regulation . 
Article 2 
1. This Regulation shall enter into force on the twentieth day following that of its 
publication in the Official Journal of the European Union .  
2. This Regulation shall apply from [OPOCE: 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.]  
In the Anne x, point (1), points (a), (b), (d) and (e) of point (2) and points (a) and (b) 
of point (3)  shall apply from 1 June 2017.  
3. By way of derogation from paragraph 2, substances and mixtures may, before 
[OPOCE: please insert specific date of applicability determ ined under the first 
subparagraph of paragraph 2], 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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