EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending the Appendices to Annex XVII to Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) as regards CMR substances  
(Text with EEA relevan ce)  EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending [the Appendices to ] Annex XVII to Regulation (EC) No 1907/2006 of the 
European Parliament and of the Council concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) as regards CMR substances  
(Text with EEA relevance)  
THE EUROPEAN COMMISSIO N, 
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to 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), 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 91/15 5/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
68(2) thereof,  
Whereas:  
(1) Entries 28 , 29 and  30 of Annex XVII to Regulation (EC) No 1907/2006 prohibit the 
placing on the market or use for supply to  the general public of substances tha t are 
classified as carcinogenic, mutagenic or reproductive toxicant (CMR), categories 1A 
or 1B , and of mixtures containing such substances in specified concentration s. The 
substances concerned are listed in Appendices 1 to 6 to that Annex.  
(2) Substances are classified as CMR in accordance with Regulation (EC) No 1272/2008 
of the European Parliament and of the Council2 and are listed in Part 3 of Annex VI to  
that Regulation . 
(3) Since Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006 were last 
updated to reflect new classifications of substances as CMR under Regulation (EC) No 
1272/2008 , Part 3 of Annex VI to the latter  has been  amended by Commission 
Regulation (EU) No 605/20143, Commission Re gulation (EU) 2015/12214 and 
Commission Regulation (EU ) 2016/11795 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packa ging of substances and mixtures  (OJ L 353, 31.12.2008, p.1 ). 
3 Commission Regulation (EU) No 605/2014 of 5 June 2014 amend ing, for the purposes of introducing 
hazard and precautionary statements in the Croatian language and its adaptation to technical and 
scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on 
classification, labelli ng and packaging of substances and mixtures  (OJ L 167, 6.6.2014, p.36 ). 
4 Commission Regulation (EU) No  2015/1221 of 24 July 2015  amending Regulation (EC) No 1272/2008 
of the European Parliament and of the Council on classification, labelling and packaging  of substances 
and mixtures, for the purposes of its adaptation to technical and scientific progress  (OJ L 197, 
25.7.2015, p.10 ) 
5 Commi ssion Regulation (EU) No 2016/1179 of 19 July 2016 amending, for the purposes of its 
adaptation to technical and scienti fic progress, Regulation (EC) No 1272/2008 of the European EN 3   EN (4) The substance formaldehyde was included in the Community Rolling Action Plan 
(CoRAP ) for evaluation of its emission/exposure to consumers, which led to a 
decision by the Agency requiring registrants to provide data. In the light of the data 
provided, the Commission asked the Agency to make a general assessment of 
formaldehyde, including its industrial and professional uses, to enable the Commission 
to decide whether to request the Agency to prepare an Annex XV dossier for 
restriction. Therefore formaldehyde should not be included in the scope of entry 29 of 
Annex XVII to Regulation (EC) N o 1907/2006.  
(5) As operators may apply the harmonised classifications set out in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008 at an earlier date, they should be able to  apply  the 
provisions of this Regulation earlier, on a voluntary basis.  
(6) Regulation ( EC) No 1907/2006 should be amended accordingly . 
(7) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVI I to Regulation (EC) No 1907/2006 is amended in accordance with the Annex.  
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. It shall apply from the  date of entry into force , with the exception of  
- paragraphs (1), (2)  and (3) of the Annex , which shall apply on 1 March 2018 , and  
- paragraph (4) (a) of the Annex which shall apply on 1 March 2018 to the extent that it relates 
to the following substances:  
bisphenol A ; [phenol, dodecyl -, branched] ; [phenol, 2 -dodecyl -, branched] ; [phenol, 3 -
dodecyl -, branched] ; [phenol, 4 -dodecyl -, branched] ; [phenol, (tetrapropenyl) 
derivatives]; chlorophacinone (ISO);  coumatetralyl (ISO); difenacoum (ISO); 
flocoumafen (ISO); disodium octaborate anhydrous;  disodium octaborate tetrahydrate ; 
bromadiolone (ISO); difethialone; [perfluorononan -1-oic acid, and its sodium and 
ammonium salts]; dicyclohexyl phthalate  and triflumizole (ISO).  
This Regulation shall be bindin g in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker  
                                                                                                                                                         
Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ 
L 195, 29.7.2016, p.11 ).