EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex III to Regu lation (EC) No 1223/2009 of the European Parliament and 
of the Council on cosmetic products 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
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,  
After consulting the Scientific Committee on Consumer Safety, Whereas: (1) Following the 2001 scientific study entitled “U se of permanent hair dyes and bladder 
cancer risk”, the Scientific Committee on Cosmetic Products and Non-Food Products 
intended for Consumers, subsequently replaced by the Scient ific Committee on 
Consumer Products (SCCP), pursuan t to Commission Decision 2004/210/EC
2, 
concluded that the potential ri sks of the use of hair dyes were of concern. The SCCP, 
in its opinions, recommended that the Comm ission takes further st eps to control the 
use of hair dye substances. 
(2) The SCCP further recommended an overall safe ty 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 Commission 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 requi red 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 Scientific Committee on Consumer Safety 
(SCCS) pursuant to Commission Decision 2008/721/EC3, assessed the safety of 
individual substances for which updated files had been submitt ed by the industry.  
(5) Taking into account the final opinions given by the SCCS on the safety of individual 
substances, it is appropriate to limit the maxi mum concentrations of nine assessed hair 
dye substances and to list them in Annex III to Regulati on (EC) No 1223/2009. 
(6) 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 
                                                 
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 field 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 data yet available, the SCCS, in its opi nion of 21 September 2010, did not raise any 
major concern regarding genotoxicity and ca rcinogenicity of hair dyes and their 
reaction products currently used in the Union. 
(7) The sensitising potential of i ndividual hair dye su bstances has been addressed in their 
risk assessments by the SCCS. In order to better inform the consumer about possible 
adverse effects of hair dye use and to lowe r the risk of sensitisation to hair dye 
products among consumers, appropriate warnin gs should be printed on the label of 
oxidative hair dye products and of non-oxida tive hair dye products containing hair dye 
substances with an extreme or  strong sensitising potential.  
(8) The definition of a hair product in Re gulation (EC) No 1223/2009 excluded its 
application on eyelashes. 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 
Thioglycolic acid and its salts on eyelashes. 
(9) The SCCS, in its opinion on Thioglycolic  acid and its salts  of 11 November 2013, 
concluded that the general use (personal use by consum ers at home) of products 
intended for eyelash waving containing Thioglycolic ac id and its salts is not 
recommended because of the risk of eye irritation during self-a pplication. However, 
the concentration of Thioglycolic acid and it s salts in those products is safe up to 11% 
when applied on eyelashes by a professional wh ich reduces the risk of a direct contact 
with the eyes. In addition, the SCCS concluded that the use of Thioglycolic acid and its salts up to 5% is safe for use as a depilatory when used as intended. The safety of these types of cosmetic products highly depends on responsible risk management 
including warnings and ex tensive guidance for use. 
(10) On the basis of the scientific assessment of  Thioglycolic acid and its salts their use 
should be allowed in products  intended for eyelash waving and for use as depilatories. 
However, in order to avoid any risk conn ected with the self-a pplication of products 
intended for eyelash waving by consumers, they should be allowed for professional 
use only. In order to allow professionals to inform consumers about possible adverse 
effects of the application of products cont aining Thioglycolic acid and its salts on 
eyelashes and to lower the risk of skin sensitisation to thos e products, appropriate 
warnings should be printed on their labels.  
(11) Annex III to Regulation (EC) No 1223/2009 shou ld therefore be amended accordingly.  
(12) The application of that restriction should be  deferred to allow the industry to comply 
with the requirements for hair dye products . In particular, undertakings should be 
granted twelve months to place on the ma rket compliant products and to withdraw 
from the market non-compliant pr oducts after the en try into force of this Regulation.  
(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 amended in accordan ce with the Annex to this 
Regulation.  
EN 4   EN Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply from 1 May 2015, except the provis ions in point 2 of the Annex which shall 
apply from (please insert date – twelve months  after 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