EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council on cosmetic products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annexes II and 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 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) Following the publication of a scientific study in 2001, entitled  “Use 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 Scientific 
Committee on Consumer Products (SCCP) pursuant to Commission Decision 
2004/210/EC2, concluded that the potential health risks of the use of hair dyes were of 
concern.  
(2) The SCCP further recommended an overall safety assessment strategy for hair dye 
substances including the requirements for testing substances used in hair dye products 
for their poten tial genotoxicity or carcinogenicity.  
(3) Following the opinions of the SCCP, the Commission agreed with Member States and 
stakeholders on an overall strategy to regulate substances used in hair dye products 
according to which the industry was required to subm it files, containing updated 
scientific data on the safety of hair dye substances, for a risk assessment by the SCCP.  
(4) Having suc ceeded t he SCCP pursuant to Commission Decision 2008/721/EC3, the 
Scientific Committee on Consumer Safety (SCCS)  assessed the safety of individual 
hair dye substances for which updated files had been submitted by the industry.  
(5) As a result of the assessement by the SCCS, in order to ensure the safety of hai r dye 
products for human health  it is necessary  to prohibit t he use of three hair dye 
substances , 1,2,4 -Trihydroxybenzene4, 2-[(4-Amino -2-nitrophenyl) -amino] -benzoic 
acid5 and 4-Amino -3-hydroxytoluene6, based on  the final opinions given by the SCCS 
on their safety.  In addition, in light of the final opinions by the SCCS on other six hair 
                                                 
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 Decisi on 2004/210/EC  (OJ L 241, 10.9.2008, p. 21 ). 
4 SCCS/1598/18  
5 SCCS/1497/12  
6 SCCS/1400/11  EN 2  EN dye substances , Dimethylpiperazinium Aminopyrazolopyridine HCl7, 
Methylimidazoliumpropyl p -phenylenediamine HCl8, HC Orange No. 69, Acid Orange 
710, Tetrabromophenol Blue11 and Indigofera Tinctoria12, it is appropriate to limit their 
maxi mum concentrations for use in hair dye products.   
(6) The definition of a hair product laid down in point (1)(c) of the Preamble to Annexes 
II to VI  to Regulation (EC) No 1223/2009 exclude s the application of  hair dye 
substances on eyelashes , based  on a different level of risk of applying a  cosmetic 
product on the hair on the head as compared to applying the same product  on 
eyelashes. A specific safety assessment was therefore needed for the application of 
hair dye substances on eyelashes.  
(7) The s ubstance  2-Methoxy methyl -p-Phenylenediamine and its sulfate are listed under 
entry 292  in Annex III to Regulation (EC) No 1223/2009 . Taking into account the 
conclusions of the latest SCCS opinion13 on the use of th ose substance s on eyelashes , 
the field of application of the restriction to which they are subject should be extended 
to products intended for colouring eyelashes . 
(8) In order to avoid any risk related to  self-application by consumers of products 
intended for colouring eyelashes  that contain 2-Methoxy methyl -p-Phenylenediamine 
and its sulfate , those products  should be allowed for professional use only.  
(9) In order to inform consumers and professionals about po ssible adverse effects of the 
use of hair dyes and products intended for colouring eyelashes with the aim to  lower 
the risk of skin sensitisation to those products, appropriate warnings should be printed 
on their labels.  
(10) Regulation (EC) No 1223/2009 shoul d therefore be amended accordingly.  
(11) It is appropriate to provide for reasonable periods of time in order for the industry to 
adapt to the new requirements and to phase out cosmetic products which do not 
comply with those requirements . 
(12) The measures provide d for in this Regulation are in accordance with the opinion of 
the Standing Committee on Cosmetic Products,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.  
 
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 . 
                                                 
7 SCCS/1584/17  
8 SCCS/1609/19  
9 SCCS/1579/16  
10 SCCS/1536/14  
11 SCCS/1610/19  
12 SCCS/1615/20  
13 SCCS/1603/18   EN 3  EN This Regulation shall be binding in its entirety and directly applicable in all Member  States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen