EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2016) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex III to Regula tion (EC) No 1223/2009 of th e European Parliament and 
of the Council on cosmetic products 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) …/.. 
of XXX  
amending Annex III to Regulation (EC) No  1223/2009 of the European Parliament and 
of the Council on cosmetic products 
(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 1223/2009 of the European Parliament and of the 
Council of 30 November 2009 on cosmetic products
1, and in particular Article 31(1) thereof, 
 
Whereas: (1) Following the publication of a scientific st udy in 2001, entitled “Use of permanent hair 
dyes and bladder cancer risk”, the Scient ific Committee on Cosmetic Products and 
Non-Food Products intended for Consumers, su bsequently replaced by the Scientific 
Committee on Consumer Products (SCCP ) pursuant to Commission Decision 
2004/210/EC
2, concluded that the potential risks of the use of hair dyes were of 
concern. The SCCP, in its opinions, recomm ended that the Commission take further 
steps to control the use of hair dye substances. 
(2) The SCCP further recommended an overall sa fety assessment strategy for hair dye 
substances including the requirements for tes ting substances used in hair dye products 
for their potential genotoxi city or carcinogenicity. 
(3) Following the opinions of the SCCP, the Comm ission agreed with Member States and 
stakeholders on an overall strategy to regulat e substances used in hair dye products 
according to which the industry was require d to submit files, containing updated 
scientific data on the safety of hair dye s ubstances, for a risk assessment by the SCCP.  
(4) The SCCP, subsequently replaced by the Sc ientific Committee on Consumer Safety 
(SCCS) pursuant to Commission Decision 2008/721/EC3, assessed the safety of 
individual hair dye substances for which updated files had been submitted by the industry.  
(5) As regards the evaluation of possible c onsumer health risks by reaction products 
formed by oxidative hair dye substances dur ing the hair dyeing process, based on the 
data yet available, the S CCS, in its opinion of 21 Se ptember 2010, did not raise any 
                                                
 
1 OJ L 342, 22.12.2009, p. 59. 
2 Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of 
consumer safety, public health and the environment (OJ L 66, 4.3.2004, p. 45). 
3 Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific 
Committees and experts in the fiel d of consumer safety, public health and the environment and 
repealing Decision 2004/210/EC (OJ L 241, 10.9.2008, p. 21). EN 3   EN major concern regarding genotoxicity and carcinogenicity of hair dyes and their 
reaction products currently used in the Union. 
(6) In order to ensure the safety of hair dye products for human healt h, it is appropriate to 
set up maximum concentrations of  ten assessed hair dye substances and to list them in 
Annex III to Regulation (EC) No 1223/2009, by taking into account the final opinions 
given by the SCCS on their safety. 
(7) Since substances N,N’-bis-(2-hydroxyet hyl)-2-nitro-p-phenylenediamine and 2,6-
Dihydroxyethylaminotoluene are currently re gulated under generic entries 8 and 9 of 
Annex III to Regulation (E C) No 1223/2009, separate refe rence numbers should be 
created for these substances, taking into account conclusions of the SCCS on their 
safety. 
(8) The definition of a hair product in Regulation (EC) No 1223/2009 excluded the 
application of  hair dye substances on ey elashes. That exclusion was motivated by the 
fact that the level of risk is different when cosmetic products are applied on the hair on 
the head and on eyelashes. A specific safety assessment was therefore needed for the application of hair dye s ubstances on eyelashes. 
(9) The SCCS, in its opinion on oxidative hair dye substances and hydrogen peroxide used 
in products to colour eyelashes of 25 Ma rch 2015, concluded that oxidative hair dye 
substances Toluene-2,5-diamine, p-Aminophenol, 2-Methylresorcinol, 
Tetraaminopyrimidine Sulfate, Hydroxyeth yl-p-Phenylenediamine Sulfate and 2-
Amino-3-Hydroxypyridine, listed in Anne x III to Regulation (EC) No 1223/2009 and 
found safe for use in hair dye products, can be  safely used by prof essionals in products 
intended for colouring eyelashes. 
(10) On the basis of the scientific assessment of those substances, their use should be 
allowed in products intended for colouring eyelashes. However, in order to avoid any risk connected with the self-application of  products intended for colouring eyelashes 
by consumers, they should be allowed fo r professional use only. In order to allow 
professionals to inform consumers about possi ble adverse effects of  the application of 
products intended for colouring eyelashes and to  lower the risk of skin sensitisation to 
those products, appropriat e warnings should be printed on their labels.  
(11) Regulation (EC) No 1223/2009 should th erefore be amended accordingly.  
(12) The application of the new requirements s hould be deferred to allow the industry to 
make the necessary adjustments to product formulations and labelling. In particular, undertakings should be granted twelve mont hs from the entry into force of this 
Regulation to take the necessary measures to place on the market only products that comply with the new maximum concentra tions and labelling requirements and to 
withdraw from the market the products that  do not comply with those requirements.  
(13) The measures provided for in this Regula tion are in accordance with the opinion of 
the Standing Committee on Cosmetic Products,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex III to Regulation (EC) No 1223/2009 is ame nded in accordance with the Annex to this 
Regulation. EN 4   EN Article 2 
This Regulation shall enter into  force on the twentieth day follo wing that of its publication in 
the Official Journal of  the European Union . 
It shall apply from [date = 12 months after the date of entry into force of this Regulation]. 
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