EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
COM  
Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Council Directive 76/768/EEC concern ing cosmetic products for the purposes 
of adapting Annex III there to to technical progress 
EN  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Council Directive 76/768/EEC concern ing cosmetic products for the purposes 
of adapting Annex III thereto to technical progress 
(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) The Scientific Committee on Consumer Products, replaced by the Scientific 
Committee on Consumer Safety
2, concluded in its “Memorandum on hair dye 
substances and their skin sensitizing properties” published on 29 March 2007 that 
contact allergies caused by hair dye products  are an increasingly important health 
problem for consumers and society, often causing acute and severe dermatitis to individuals. A person sensitised to a hair dye  substance used in hair dye products may 
eventually develop skin allergy to that substance. 
(2) In order to better inform the consumer a bout the possible adverse effects of hair 
colouring and to lower the ri sk of sensitization to hair dye products among consumers, 
additional warnings should be printed on th e label of oxidative hair dye products and 
of certain non-oxidative hair  dye products containing extr eme and strong sensitizing 
substances. Therefore, the obligatory cond itions of use and warnings laid down for 
respective hair dye substances in column “f” of Annex III to Directive 76/768/EEC 
should be amended. 
(3) Directive 76/768/EEC should therefore be amended accordingly. 
(4) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Cosmetic Products, 
                                                
 
1 OJ L 262, 27.9.1976, p. 169. 
2 The name of the committee was changed by Commission Decision 2008/721/EC (OJ L 241, 10.9.2008, 
p. 21).  
EN 3   EN 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 [insert concrete date = 6 months after 
the entry into forc e 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. 
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 Co mmission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
Member States shall take all necessa ry measures to ensure that after [Day, Month, Year = 24 
months after the entry in to force of the Directive]  no cosmetic products which fail to 
comply with this Directive are placed on th e market by Community manufacturers or by 
importers established within the Community. 
Member States shall take all necessa ry measures to ensure that after [Day, Month, Year = 36 
months after the entry in to force of the Directive]  no cosmetic products which fail to 
comply with this Directive are sold or dispos ed of to the final consumer in the Community. 
Article 4 
This Directive shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of  the European Union . 
Article 5 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 […] 
 Member of the Commission  
EN 4   EN ANNEX  
1. Part 1 of Annex III is amended as follows: 
(a) Under reference numbers 8 and 9, in column f,  points (a) and (b), the text “Can cause an 
allergic reaction.” is replaced by the following: 
“ 
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
(b) Under reference numbers 8a and 9a, in column f, points (a) and (b), th e text “Can cause an 
allergic reaction.” is replaced by the following: 
“ 
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
(c) Under reference number 16, in column f, the te xt "Can cause allergic reaction." is replaced 
by the following: 
“ 
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
  
EN 5   EN (d) Under reference number 22, in column f, sub- points 1 and 2 of point (a), the following text 
is added:  
“ 
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
(e) Under reference numbers 202 and 203, in column f, point (a), the text  “Can cause allergic 
reaction.” is replaced by the following: 
“ 
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
(f) Under reference numbers 193 and 205, in column f, point (a), the foll owing text is added: 
“ 
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
2. Part 2 of Annex III is amended as follows: 
(a) Under reference numbers 3 in column f, points (a) and (b), the text “Can cause allergic 
reaction.” is replaced by the following:  
EN 6   EN “ 
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
(b) Under reference numbers 4, 20, 26, 32, 34, 35, 36, 37, 38, 39 and 44, column f, the 
following text is added: 
“ 
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
(c) Under reference numbers 5, 6,  12, 19, 21, 22, 25 and 33, in colu mn f, the text “Can cause 
allergic reaction.” is replaced by the following: 
“ 
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
(d) Under reference numbers 10, 11 and 16, in column f, point (a), the text  “Can cause allergic 
reaction.” is replaced by the following: 
“ 
 ! Hair colorants can cause severe allergic reactions. 
Read and follow instructions.  
EN 7   EN This product is not intended for use on persons under the age of 16. 
Temporary “black henna” tattoos ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
(e) Under reference numbers 10, 11 and 16, column f, point (b) is deleted. 
 
(f) Under reference numbers 27, 48 and 56, in colu mn f, the following points (a) and (b) are 
added: 
“(a)  
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.  
 
(b)  
 ! 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 ma y 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 r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.” 
 
(g) Under reference numbers 31, 49, 50 and 55, in co lumn f, point (a), the following text is 
added: 
“ 
 ! 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 ma y increase your risk of allergy. 
Do not colour your hair if: - You have a rash on your face or sensitive, irritated and damaged scalp.  
EN 8   EN - You have ever experienced any r eaction after colouring your hair. 
- You have experienced a reac tion to a temporary “black henna” tattoo in the past.”