EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 1223/2009 of the European Parliament and of 
the Council on cosmetic products   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annex II to Regulation (EC) No 1223/2009 of the European Parliament and of 
the Council on cosmetic products  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1223/2009 of the  European Parliament and of the 
Council of 30 November 2009 on cosmetic products1, and in particular Article 31(1) thereof,  
Whereas:  
 
(1) The substa nce 2-Chloro -p-Phenylenediamine , including its sulphate and 
dihydrochloride salts, is used in formulations  for colouring eyebrows and eyelashes in 
a maximum concentration of 4,6  %. The Scientific Committee on Consumer Safety 
(SCCS ) stated in its opinion of 19 September 20132 (“the SCCS opinion”) that no 
sufficient margin of safety could be deduced for the use of 2-Chloro -p-
Phenylenediamine  in oxidative hair dye formulations for eyebrows and eyelashes  in a 
concentration of maximum 4, 6 %. The SCCS further stated that it was not possible to 
give a conclusion on the genotoxic potential of 2 -Chloro -p-Phenylenediamine  based 
on the available data and the lack of a proper in vivo  test for gene mutation induction . 
Therefore, the SCCS did not consider the use of 2 -Chloro -p-Phenylenediamine safe 
for the consumer . The SCCS has subsequently clarified that it is of the opinion that 
sulphate and dihydrochloride salts of 2 -Chloro -p-Phenylenediamine  should be handled 
with the same caution as 2 -Chloro -p-Phenylenediamine until proven to be safe , 
because  they have the same core structure, including genotoxic potential, as 2 -Chloro -
p-Phenylenediamine . Moreover, the SCCS has clarified that the scope of the SCCS 
opinion and its conclusion can be extended to the hair on the head3.  
(2) In light of th e SCCS opinion, and the subsequent clarification by SCCS, there is a 
potential risk to human health arising from the use of 2 -Chloro -p-Phenylenediamine , 
its sulphate and dihydrochloride salts in products for colour ing eyebrows and 
eyelashe s. With regard to products for colouring the hair on the head, the exposure  to 
the substance is even higher, since those products are applied to a larger surface of the 
body. On that basis, and in light of the clarification by SCCS, there is also a potential 
risk to human health  arising  from the use of 2 -Chloro -p-Phenylenediamine , its 
sulphate and dihydrochloride salts in products for colouring the hair of the head . 
Therefore , 2-Chloro -p-Phenylenediamine, its sulphate and dihydrochloride salts  
should be prohibited in hair dye products,  including eyebrow dye products , and in 
eyelash dye products and added in the list of prohibited substances in Annex II to 
Regulation (EC) No 1223/2009 .  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS/1510/13.  
3  Minutes of the SCCS plenary meeting of 21 -22 June 2018 . EN 2  EN (3) It is appropriate to provide for reasonable periods of time in order for the industry to 
adapt to the new prohibition. When determining the length of those periods, the 
interest of the economic operator s should be balanced against the specific health risk 
factors identified.   
(4) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(5) The measures provided for in this Regulation  are in accordance with the opinion of 
the Standing Committee on Cosmetic Products,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex II to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this 
Regulation.  
Article 2  
From [date = 6 months  after the date of entry into force ] hair dye products, including eyebrow 
dye products, and eyelash dye products  containing the substance s prohibited by this 
Regulation shall not be placed on the Union market.   
From [date = 9 months  after the date of entr y into force] hair dye products, including eyebrow 
dye products, and eyelash dye products containing the substance s prohibit ed by this 
Regulation shall be not be made available on the Union market.  
Article 3  
This Regulation shall enter into force on the t wentieth day following that of its publication in 
the Official Journal of the European Union . 
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