EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending, for the purposes of its adaptation to technical and scientific progress, 
Regulation (EC) No 1272/200 8 of the European Parliament and of the Council on 
classification, labelling and packag ing of substances and mixtures 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending, for the purposes of its adaptation  to technical and scientific progress, 
Regulation (EC) No 1272/2008 of the Europe an Parliament and of the Council on 
classification, labelling and packagi ng 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, labe lling and packaging of substances and 
mixtures, amending and repealing Directiv es 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006
1, and in particular Ar ticle 37(5) thereof, 
Whereas:  (1) Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains two lists of harmonised 
classification and labelling of hazardous substances. Table 3.1 lists the harmonised 
classification and labelling of hazardous subs tances based on the criteria set out in 
Parts 2 to 5 of Annex I to Regulati on (EC) No 1272/2008. Table 3.2 lists the 
harmonised classification and labelling of hazardous substances based on the criteria 
set out in Annex VI to Council Directive 67/548/EEC
2.  
(2) Since Directive 67/548/EEC has been repeal ed with effect from 1 June 2015, Table 
3.2. in Part 3 of Annex VI should be deleted. However, in order to ease the transition 
to full applicability of Regulation (EC) No 1272/2008, that deletion should not take 
effect until 1 June 2017. 
(3) Proposals for new, updated or deleted ha rmonised classificatio n and labelling of 
certain substances have been submitted to the European Chemicals Agency (ECHA) pursuant to Article 37 of Regulation (E C) No 1272/2008. Based on the opinions on 
those proposals issued by the Committee fo r Risk Assessment of ECHA (RAC), as 
well as on the comments received from the parties concerned, it is appropriate to 
introduce, update or delete harmonised cl assification and labelling of certain 
substances. 
(4) With regard to the substance lead, RAC proposes in its scie ntific opinion of 
5 December 2013 to classify it as toxic for reproduction category 1A. However, in view of the lack of certainty regarding th e degree of bioavailabil ity of lead in the 
massive form, a distinction needs to be made  between the massive form (particle size 
of more than 1 mm) and the powder form (p article size up to 1 mm). It is therefore 
appropriate, for the time being, to introdu ce a specific concentration limit (SCL) of ≥ 
                                                
 
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). EN 3   EN 0,03% for the powder form and a gene ric concentrati on limit (GCL) of ≥ 0,3% for the 
massive form.  
(5) With regard to the copper substances, th e environmental classi fication recommended 
in the RAC opinions of 4 December 2014 should be included in Annex VI of 
Regulation 1272/2008 since sufficient scientific  evidence is availa ble justifying this 
new classification. However, the proposed M-fa ctors should not be included since they 
require further assessment by RAC in view of  new available scientific data on aquatic 
toxicity.  
(6) Regulation (EC) No 1272/2008 s hould be amended accordingly. 
(7) Compliance with the new harmonised cla ssifications 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 classifications and to sell existing stocks. This period of time w ill also be necessary to allow suppliers to 
adapt to and to comply with other legisl ative obligations resulting from the new 
harmonised classifications for substances such  as those provided for in Article 22(f) or 
Article 23 of Regulation (EC) No 1907/2006 of  the European Parliament and of the 
Council
3, those provided for in Article 50 of Regulati on (EU) No 528/2012 of the 
European Parliament and of the Council4 or those in Article 44 of Regulation (EC) No 
1107/2009 of the European Parliament and of the Council5.  
(8) In line with the transition al provisions of Regulati on (EC) No 1272/2008 which allow 
the application of the new pr ovisions at an earlie r stage on a voluntar y basis, suppliers 
should have the possibility of applying th e new harmonised classifications and of 
adapting the labelling and packaging accordingly on a voluntary basis before the deadline for compliance.  
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee established by Article 1 33 of Regulation (EC) No 1907/2006, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Regulation (EC) No 1272/2008 is amended as follows: 
(1) Annex VI is amended in accordance with the Annex to this Regulation. 
(2) In Annex VI, table 3.2. is deleted. 
                                                
 
3 Regulation (EC) No 1907 /2006 of the European Parliament an d 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, OJ L 396, 30.12.2006, p. 1.  
4 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). 
5 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 4   EN 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 [ Date of entry into force plus 18 months ] 
Article 1(2) shall a pply from 1 June 2017. 
3. By way of derogation from paragraph 2, substances and mixtures may, before [ date 
of applicability determined under the first subparagraph of paragraph 2 ], be 
classified, labelled and packaged in acco rdance with Regulation (EC) No 1272/2008 
as amended by this Regulation. 
4. By way of derogation from paragraph 2, subs tances and mixtures classified, labelled 
and packaged in accordance with Regulation (EC) No 1272/2008 and placed on the market before [ date of applicability determined under the first subparagraph of 
paragraph 2 ] shall not be required to be rela belled and repackaged in accordance 
with this Regulation before [ date of applicability dete rmined under the first 
subparagraph of paragraph 2 plus 2 years ]. 
This Regulation shall be binding in its entire ty and applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  […]