EN    EN  
 EUROPEAN COMMISSION   
Brussels, XXX  
[…](2011) XXX draft   
  
COMMISSION IMPLEMENTING DIRECTIVE ../…/EU    
of XXX  
amendin g, for the purpose of adaptation to technical pro gress, Annexes II and III to 
Directive 76/768/EEC relating to cosmetic products   
(Text with EEA relevance)   
EN 1   EN COMMISSION IMPLEMENTING DIRECTIVE ../…/EU 
of XXX  
amending, for the purpose of adaptation to  technical progress, Annexes II and III to 
Council Directive 76/768/EEC relating to cosmetic products 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the 
laws of the Member States relating to cosmetic products
1, and in particular Article 8(2) 
thereof,  
After consulting the Scientific Committee on Consumer Safety, 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, subsequently replaced by the Scientific 
Committee on Consumer Products ("SCCP") , pursuant to Comm ission Decision 
2004/210/EC
2, concluded that the potential risks were of concern. The SCCP 
recommended that the Commission take furthe r steps 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 genotoxicity or mutagenicity. 
(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 Decisi on 2008/721/EC of 5 August 2008 setting up 
an advisory structure of Scientific Committ ees and experts in the field of consumer 
safety, public health and the envir onment and repealing Decision 2004/210/EC3, 
                                                 
1 OJ L 262, 27.9.1976, p. 169. 
2 OJ L 66, 4.3.2004, p. 45. 
3 OJ L 241, 10.9.2008, p. 21.  
EN 2   EN assessed the safety of individual substa nces for which updated files had been 
submitted by industry.  
(5) The last step of the safety assessment st rategy was to evaluate possible consumer 
health risk by reaction products formed by oxidative hair dye substances during the 
hair dyeing process. In its opinion of 21 September 2010 the SCCS did not raise any 
major concern regarding genotoxicity and ca rcinogenicity of hair dyes and their 
reaction products currently used in the Union. 
(6) In the light of the risk assessment of the submitted safety data and the final opinions 
given by the SCCS on the safety of individua l substances and of the reaction products, 
it is appropriate to include in Part 1 of  Annex III to Directive 76/768/EEC 25 assessed 
hair dyes which are not regulated  within Directive 76/768/EEC. 
(7) The substances hydroxyethyl-2-nitro-p-tolui dine and HC Red No. 10 + HC Red No. 
11  are provisionally authorised for use in hair dye products until 31 December 2011 
under the restrictions and condi tions laid down in entries 10  and 50 in Part 2 of Annex 
III to Directive 76/768/EEC. Based on the fina l opinions given by the SCCS on their 
safety, hydroxyethyl-2-nitro-p-toluidine and HC Red No. 10 + HC Red No. 11 can be considered safe in hair dye products and li sted in Part 1 of A nnex III to Directive 
76/768/EEC. 
(8) Following the assessment by the SCCS c oncerning the substances 1-napthol and 
resorcinol, listed in Part 1 of Annex III to Directive 76/768/EEC, their maximum 
authorised concentrations in the finish ed cosmetic product should be changed.  
(9) Concerning the substance HC Red No. 16, the SCCS stated in its opinion of 14 
December 2010 that based on the low margin of safety for the use in both oxidative 
and non-oxidative hair dye formulations, HC Re d No. 16 poses a risk to the health of 
the consumer. Therefore, HC Red No. 16 s hould be listed in A nnex II to Directive 
76/768/EEC.  
(10) Directive 76/768/EEC should therefore be amended accordingly. 
(11) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Cosmetic Products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1  
Annexes II and III to Directive 76/768/EEC are ame nded in accordance with the Annex to this 
Directive. 
Article 2 
1. Member States shall adopt and publish, by [Day, Month, Year = Six months after 
the entry into force of the Directive] at the latest, the la ws, regulations and 
administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commissi on the text of those provisions.  
EN 3   EN They shall apply those provisions from [Day, Month, Year = Twelve months after 
the entry into force of the Directive] .  
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 The President   
EN 4   EN ANNEX  
Directive 76/768/EEC is amended as follows: 
(1) In Annex II, the following entry is added: 
Ref. No  Chemical name CAS No / EC No 
"X N-(2-Nitro-4-a minophenyl)-allylamine 
(HC Red n° 16) and its salts  CAS No 160219-76-1" 
 
 
(2) Annex III is amended as follows: (a) Part 1 is amended as follows: (i) The following entries are added:  
Restrictions  
Ref. 
No. 
  
Substance Field of 
application and/or 
use Max. authorized 
concentration in 
the finished 
cosmetic product Other limitations and 
requirements  
Conditions of use 
and warnings which 
must be printed on 
the label 
"X N,N-bis(2-hydroxyethyl)-
p-phenylenediamine 
sulfate (CAS No 54381-
16-7) (EU No 259-134-5) 
 Hair dye 
substance in oxidative hair dye products   After mixing under oxidative 
conditions the maximum concentration applied to hair must not exceed 2.5%  
- Do not use with nitrosating 
agents 
- Maximum nitrosamine 
content: 50 µg/kg 
- Keep in nitrite-free 
containers As mentioned in 
reference number 252 column f (a) 
 
 4-Chlororesorcinol (CAS 
No 95-88-5) (EU No 202-
462-0) Hair dye 
substance in oxidative hair dye products   
 After mixing under oxidative 
conditions the maximum concentration applied to hair must not exceed 2.5% As mentioned in 
reference number 252 column f (a) 
 Tetraaminopyrimidine 
sulphate  (CAS No 5392-
28-9) (EU No  226-393-0)  (a) Hair dye 
substance in oxidative hair dye products  
(b) Hair dye 
substance in non-oxidative hair dye products  
  (b) 3.4% (2.0% 
free base) (a) After mixing under 
oxidative conditions the maximum concentration applied to hair must not exceed 3.4% (2.0% free base) (a) As mentioned in 
reference number 252 column f (a) 
 
 Hydroxyethyl-p-
phenylenediamine Hair dye 
substance in  After mixing under oxidative 
conditions the maximum As mentioned in 
reference number  
EN 5   EN sulphate (CAS No 93841-
25-9) (EU No 298-995-1) oxidative hair dye 
products concentration applied to hair 
must not exceed 2% 252 column f (a) 
 Dihydroxyindole (CAS 
No 3131-52-0) (EU No 412-130-9) (a) Hair dye 
substance in 
oxidative hair dye products  
(b) Hair dye 
substance in non-oxidative hair dye products  
 
 (b) 0.5% (a) After mixing under 
oxidative conditions the 
maximum concentration applied to hair must not exceed 0.50% (a) As mentioned in 
reference number 
252 column f (a) 
(b) As mentioned in 
reference number 252 column f (b) 
 
 5-Amino-4-chloro-o-cresol 
HCl (CAS No 110102-85-7)   Hair dye 
substance in oxidative hair dye products  
  After mixing under oxidative 
conditions the maximum concentration applied to hair must not exceed 1.5% 
(calculated for the 
hydrochloride salt) As mentioned in 
reference number 252 column f (a) 
 6-Hydroxyindole (CAS No 
2380-86-1) (EU No 417-
020-4) Hair dye 
substance in oxidative hair dye products   
 After mixing under oxidative 
conditions the maximum concentration applied to hair must not exceed 0.5% As mentioned in 
reference number 252 column f (a) 
 Isatin (CAS No 91-56-5) 
(EU No 202-077-8) Hair dye 
substance in non-oxidative hair dye products 1.60%  As mentioned in 
reference number 252 column f (b)  
 
 2-Amino-3-
hydroxypyridine (CAS No 16867-03-1) (EU No 
240-886-8) Hair dye 
substance in oxidative hair dye products  After mixing under oxidative 
conditions the maximum concentration applied to hair must not exceed 1.0% As mentioned in 
reference number 252 column f (a) 
 1-Acetoxy-2-
methylnaphthalene (CAS 
No 5697-02-9) (EU No 
454-690-7) Hair dye 
substance in oxidative hair dye products  After mixing under oxidative 
conditions the maximum concentration applied to hair must not exceed 2.0% (When both 2-methyl-1-naphthol and 1-acetoxy-2-
methylnaphthalene are present 
in a hair dye formulation, the maximum concentration on the head of 2-methyl-1-naphthol should not exceed 2.0%.) As mentioned in 
reference number 252 column f (a) 
 
 2-Methyl-1-naphthol 
(CAS No 7469-77-4) (EU No 231-265-2)
 Hair dye 
substance in oxidative hair dye products  After mixing under oxidative 
conditions the maximum concentration applied to hair must not exceed 2.0% (When 
both 2-methyl-1-naphthol and 
1-acetoxy-2-methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-methyl-1-naphthol should not exceed 2.0%.) As mentioned in 
reference number 252 column f (a) 
  
EN 6   EN  Acid Yellow 1 (CAS No 
846-70-8) (EU No 212-
690-2) (a) Hair dye 
substance in oxidative hair dye products  
(b) Hair dye 
substance in non-oxidative hair dye products  
  (b) 0.2%  (a) After mixing under 
oxidative conditions the maximum concentration applied to hair must not exceed 1.0%  (a) As mentioned in 
reference number 252 column f (a) 
(b) As mentioned in 
reference number 252 column f (b)  
 4-Nitro-o-
phenylenediamine 
sulphate (CAS No 68239-82-7) (EU No 269-476-7)  Hair dye 
substance in oxidative hair dye products  After mixing under oxidative 
conditions the maximum concentration applied to hair must not exceed 0.5% As mentioned in 
reference number 252 column f (a) 
 HC Red No. 7 (CAS No 
24905-87-1) (EU No 246-
521-9) Hair dye 
substance in non-oxidative hair dye products 1.0 % - Do not use with nitrosating 
systems 
- Maximum nitrosamine 
content: 50 µg/kg 
- Keep in nitrite-free 
containers As mentioned in 
reference number 252 column f (b) 
 
 HC Yellow No. 4 (CAS 
No 59820-43-8) (EU No 258-002-4)
 Hair dye 
substance in non-
oxidative hair dye 
products 1.5 % - Do not use with nitrosating 
agents 
- Maximum nitrosamine 
content: 50 µg/kg 
- Keep in nitrite-free 
containers  
 HC Yellow No. 2 (CAS 
No 4926-55-0) (EU No 
225-555-8) (a) Hair dye 
substance in oxidative hair dye products  
(b) Hair dye 
substance in non-
oxidative hair dye 
products  
  b) 1.0%
  (a) After mixing under 
oxidative conditions the maximum concentration applied to hair must not exceed 0.75%  
For (a) and (b): 
- Do not use with nitrosating 
agents 
- Maximum nitrosamine 
content: 50 µg/kg 
- Keep in nitrite-free 
containers (a) As mentioned in 
reference number 252 column f (a)  
 HC Orange No. 1 (CAS 
No 54381-08-7) (EU No 259-132-4)  Hair dye 
substance in non-oxidative hair dye products 1.0 %   
 HC Red No. 1 (CAS No 
2784-89-6) (EU No 220-
494-3) Hair dye 
substance in non-oxidative hair dye products 1.0 %  As mentioned in 
reference number 252 column f (b)  
EN 7   EN  HC Yellow No. 9 (CAS 
No 86419-69-4) (EU No 
415-480-1) Hair dye 
substance in non-oxidative hair dye products 0.5% - Do not use with nitrosating 
agents 
- Maximum nitrosamine 
content: 50 µg/kg 
- Keep in nitrite-free 
containers  
 HC Yellow No. 7 (CAS 
No 104226-21-3) (EU No 
146-420-6) Hair dye 
substance in non-oxidative hair dye products 0.25%   
 HC Yellow No. 13 (CAS 
No 10442-83-8) (EU No 
443-760-2) (a) Hair dye 
substance in oxidative hair dye products  
(b) Hair dye 
substance in non-
oxidative hair dye 
products  
 (b) 2.5%
  (a) After mixing under 
oxidative conditions the maximum concentration applied to hair must not exceed 2.5% 
For (a) and (b): 
- Do not use with nitrosating 
agents 
- Maximum nitrosamine 
content: 50 µg/kg 
- Keep in nitrite-free 
containers (a) As mentioned in 
reference number 252 column f (a) 
 
 Basic Yellow 57 (CAS 
No 68391-31-1) (EU No 269-943-5) Hair dye 
substance in non-oxidative hair dye 
products 2.0%   
 Acid Yellow 3 (CAS No 
8004-92-0) (EU No 305-
632-3) Hair dye 
substance in non-oxidative hair dye products 0.5%   
 Disperse Black 9 (CAS 
No 20721-50-0; CAS No 
20721-50-0) (EU No 243-
987-5) 
 Hair dye 
substance in non-oxidative hair dye products 0.3% (of the 
mixture in the ratio 1:1 of 2,2’-[4-(4-aminophenylazo)phenylimino]diethanol and lignosulfate)   
 HC Blue No.14 (CAS No 
99788-75-7) (EC No 421-470-7) Hair dye 
substance in non-
oxidative hair dye 
products 0.3% 
 - Do not use with nitrosating 
agents 
- Maximum nitrosamine 
content: 50 µg/kg 
- Keep in nitrite-free 
containers  
 Hydroxyethyl-2-nitro-p-
toluidine (CAS No (a) Hair dye 
substance in  
 (a) After mixing under 
oxidative conditions the (a) As mentioned in 
reference number  
EN 8   EN 100418-33-5) (EU No 
408-090-7) and its salts  
 oxidative hair 
dye products  
(b) Hair dye 
substance in non-
oxidative hair 
dye products   
 
 
(b) 1.0%  maximum concentration 
applied to hair must not exceed 1.0% 
For (a) and (b): - Do not use with nitrosating 
agents 
- Maximum nitrosamine 
content: 50 µg/kg 
- Keep in nitrite-free 
containers 252 column f (a) 
 
Y HC Red No. 10 + HC Red 
No. 11 (CAS No 95576-
89-9 + 95576-92-4) and its salts (a) Hair dye 
substance in 
oxidative hair dye products  
(b) Hair dye 
substance in non-oxidative hair 
dye products  
 
  
 
 (b) 2.0% (a) After mixing under 
oxidative conditions the maximum concentration applied to hair must not exceed 1.0% 
For (a) and (b): - Do not use with nitrosating 
agents 
- Maximum nitrosamine 
content: 50 µg/kg 
- Keep in nitrite-free 
containers (a) As mentioned in 
reference number 252 column f (a)" 
 
 
(ii) The entries with reference numbers 16 and 22 are replaced by the following:  
Restrictions  
Ref. 
No. 
  
Substance Field of 
application and/or 
use Max. authorized 
concentration in 
the finished 
cosmetic product Other limitations and 
requirements  
Conditions of use 
and warnings which 
must be printed on 
the label 
"16 1-Naphthol and its salts 
(CAS 90-15-3) (EU No 
201-969-4)    Hair dye 
substance in oxidative hair dye products  After mixing under oxidative 
conditions the maximum concentration applied to hair must not exceed 2.0% As mentioned in 
reference number 252 column f (a) 
22 Resorcinol (CAS No 108-
46-3) (EU No 203-585-2) (a) Hair dye 
substance in 
oxidative hair dye products  
1. general use 2. professional 
use 
(b) Hair lotions 
and shampoos  
 
   (b) 0.5% (a) After mixing under 
oxidative conditions the 
maximum concentration applied to hair must not exceed 1.25%  (a) As mentioned in 
reference number 
22 column f (a) 
(b) As mentioned in 
reference number 22 column f (b)"  
  
EN 9   EN (b) Part 2 is amended as follows: 
(i) The entries with reference numbers 10 and 50 are deleted.