EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) 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 relev ance)    
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 COMMISSION,  
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 91/155/EEC, 93/67/EEC, 93/1 05/EC and 2000/21/EC1, and in particular Article s 
68(2) and 131 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 that are 
classif ied 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 w ere 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)  2017/7763. 
(4) Regulation (EU) 2017/776 also makes changes to titles and nu mbering in Part 3 of 
Annex VI to Regulation (EC) No 1272/2008, which necessitate modification of the 
references to that Regulation in column 1 of entries 28 to 30 of Annex XVII  to 
Regulation (EC) No 1907/2006.  
                                                 
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 Commi ssion 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 substances and mixtures ( OJ L 1 16, 5.5.2017, p.1).  
EN 3   EN (5) The substance formaldehyde  was classified as a carcinogen category 1B by 
Commission Regulation (EU) No 605/20144; however  the Commission chose to omit 
it from the last updating exercise pending the outcome of an ongoing examination of 
all its uses by the European Chemicals Agency5, with a view to a po ssible specific 
restriction . In the REACH Committee of 16 March 2017, the majority of Member 
States expressed a preference to include  formaldehyde in entry 28 of Annex XVII to 
REACH notwithstanding any further specific  proposal to restrict the substance , and 
the Commission agreed to do so at the next available opportunity.  
(6) 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 th is Regulation earlier, on a voluntary basis.  
(7) Regulation (EC) No 1907/2006 should be amended accordingly . 
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 19 07/2006,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII 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 J ournal of the European Union .  
2. It shall apply from 1 December 2018 except that, to the extent that paragraph ( 2) of the 
Annex applies to the substance ‘formaldehyde . . . %’, that paragraph shall apply from the 
date of entry into force . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker  
                                                 
4 Commission Regulation (EU) No 605/2014 of 5 June 2014 amending, 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, labelling and packaging of substances and mixtures (OJ L 167, 6.6.2014, p.36).  
5 https://echa.europa.eu/documents/10162/13641/annex_xv_report_formaldehyde_en.pdf/58be2f0a -7ca7 -
264d -a594 -da5051a1c74b