EN    EN EN 
EN 1   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending, for the purpose of adaptation to technical progress, Annex III to Council 
Directive 76/768/EEC concern ing cosmetic products 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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 products1, and in particular Article 8(2) 
thereof, 
After consulting the Scientific Committee on Consumer Safety, Whereas: (1) According to the safety assessment strategy fo r hair dye substances, it was agreed with 
the Member States and stakeholders that the date of 31 December 2007 would be appropriate for the submission to the Sc ientific Committee on Consumer Safety 
(hereinafter “SCCS”) of the scientific  data on the reaction products formed by 
oxidative hair dye substances on the s calp and their safety for the consumer. 
(2) Presently, there are 29 oxidative and 2 non- oxidative hair dye substances which are 
provisionally allowed for use in cosme tic products until 31 December 2009 under the 
restrictions and conditions laid down in Part 2 of Annex III to Directive 76/768/EEC. 
The requested scientific data on the safety  of reaction products formed by oxidative 
hair dye substances were submitted by the co smetics industry to the SCCS before the 
agreed deadline of 31 December 2007. 
(3) The submitted safety data were evaluated by the SCCS. In January 2009, the SCCS 
concluded in its opinion that it is not in  the position to finally assess the risk of 
reactions products of oxidative hair dyes due to the incompleteness of the dossier 
submitted by the industry. The cosmetics industry responded to this opinion that it envisages to provide the missing da ta by September 2009 at the latest. 
(4) In view of the above, the risk assessment of the submitted additional data and the final 
opinion given by the SCCS on the safety of the reaction products wi ll still require a 
                                                
 
1 OJ L 262, 27.9.1976, p. 169.   
EN 2   EN period of time exceeding the provisi onal deadline of 31 December 2009 for the 
substances listed in Part 2 of Annex III. 
(5) Therefore, the definitive regulation of 29 oxida tive hair dye substances listed in Part 2 
of Annex III, on the basis of risk assessm ent of their reaction products, and its 
implementation into the laws of Member States will not take place before the provisional deadline. Consequently, their provisional use in cosmetic products under 
the current restrictions and conditions laid  down in Part 2 of Annex III should be 
extended. The new prolonged deadline of 31 December 2010 is considered sufficient for the definitive regulation of these substances in Part 1 of Annex III. 
(6) For non-oxidative hair dye substances HC  Orange No. 2 and 2-hydroxyethylamino-5-
nitroanisole, listed under reference number s 26 and 29 in Part 2 of Annex III, the 
SCCS gave its final opinions on their safety. The SCCS recommended maximum 
authorized concentrations in the finished cosmetic product of 1,0% for HC Orange No. 
2 and of 0,2% for 2-hydroxyeth ylamino-5-nitroanisole. Ther efore, these two hair dye 
substances can be definitively re gulated in Part 1 of Annex III.  
(7) Directive 76/768/EEC should therefore be amended accordingly. 
(8) 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 
Annex III to Directive 76/768/EEC is amende d in accordance with the Annex to this 
Directive. 
Article 2 
1. Member States shall adopt and publish, by 31 December 2009 at the latest, the laws, 
regulations and administrative provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Co mmission the text of those provisions. 
They shall apply the provisions set out in po int 1 of the Annex to this Directive from 
1 January 2010.  
They shall apply the provisions set ou t in points 2 and 3 of the Annex from [insert 
concrete date = Nine 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.  
EN 3   EN 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 
 […] 
 Member of the Commission  
EN 4   EN ANNEX  
Directive 76/768/EEC is amended as follows: 
1. In Part 2 of Annex III in column “g” of the entries relating to reference numbers 3, 4,
 5, 6, 10, 11, 12, 16, 19, 20, 21, 22, 25, 26, 27, 29, 31, 32, 33, 34, 35, 36, 37, 38, 39, 44, 48, 49, 50, 55, and 56 the date ‘31.12.2009’ is replaced by ‘31.12.2010’. 
2. In Part 1 of Annex III the following entries are added: 
Restrictions Refer
ence 
numb
er 
  
Substance Field of 
application 
and/or use Maximum 
authorized 
concentration in 
the finished 
cosmetic product Other 
limitations and 
requirements  
Conditions of use and warnings 
which must be printed on the label 
a b c d e f 
“[X]2 1-(beta-
Aminoethyl)amino-4-(beta-hydroxyethyl)oxy-2-nitrobenzene and its salts 
HC Orange No. 2
 
CAS No 85765-48-6 EINECS 416-410-1  Hair dye 
substance in non-oxidative hair dye products 
 1,0 % - Do not use 
with nitrosating systems 
- Maximum 
nitrosamine 
content: 
50µg/kg 
- Keep in 
nitrite-free containers 
Hair colorants can cause 
severe allergic reactions. 
Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy. 
Do not colour your hair if: 
- You have a rash on your face or sensitive, irritated and damaged scalp. - You have ever experienced any reaction after colouring your hair. - You have experienced a reaction to a temporary “black henna” tattoo in the past. 
[Y]3 2-[(2-Methoxy-4-
nitrophenyl)amino]ethanol 
and its salts 
2-Hydroxyethylamino-5-
nitroanisole  
CAS No 66095-81-6 EINECS 266-138-0 Hair dye 
substance in non-
oxidative hair 
dye products 
 0,2% - Do not use 
with nitrosating 
systems 
- Maximum 
nitrosamine content: 50µg/kg 
- Keep in 
nitrite-free containers 
Hair colorants can cause 
severe allergic reactions. 
Read and follow instructions. 
This product is not intended for use 
on persons under the age of 16. Temporary “black henna” tattoos may increase your risk of allergy. Do not colour your hair if: - You have a rash on your face or sensitive, irritated and damaged scalp. - You have ever experienced any reaction after colouring your hair. - You have experienced a reaction to a temporary “black henna” tattoo in the past.”
 
                                                 
2 The relevant reference number will be introduced at the time of the publication. 
3 The relevant reference number will be introduced at the time of the publication.  
EN 5   EN 3. In Part 2 of Annex III the entries relating to reference numbers 26 and 29 are deleted.