DIRECTIVES  
COMMISSION DIRECTIVE 2010/4/EU  
of 8 February 2010  
amending, for the purpose of adaptation to technical progress, Annex III to Council Directive 
76/768/EEC concerning 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) Presently, there are two non-oxidative hair dye 
substances which are provisionally allowed for use in 
cosmetic products until 31 December 2010 under the 
restrictions and conditions laid down in Part 2 of 
Annex III to Directive 76/768/EEC.  
(2) For these two non-oxidative hair dye substances, HC 
Orange No 2 and 2-hydroxyethylamino-5-nitroanisole, 
listed under reference Nos 26 and 29 in Part 2 of 
Annex III, the Scientific Committee on Consumer 
Safety (hereinafter ‘SCCS’) gave its final opinions on 
their safety. The SCCS recommended maximum auth ­
orised concentrations in the finished cosmetic product 
of 1,0 % for HC Orange No 2 and of 0,2 % for 2-hydro ­
xyethylamino-5-nitroanisole. Therefore, HC Orange No 2 
and 2-hydroxyethylamino-5-nitroanisole can be 
definitively regulated in Part 1 of Annex III.  
(3) Directive 76/768/EEC should therefore be amended 
accordingly.  
(4) In view of a smooth transition for the marketing of 
products containing HC Orange No 2 not complying 
with the labelling requirements laid down in this 
Directive, it is necessary to provide for appropriate tran ­
sitional periods.  
(5) The measures provided for in this Directive are in 
accordance with the opinion of the Standing 
Committee on Cosmetic Products,  HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Amendment to Directive 76/768/EEC  
Annex III to Directive 76/768/EEC is amended in accordance 
with the Annex to this Directive.  
Article 2  
Transposition  
1. Member States shall adopt and publish, by 1 September 
2010 at the latest, the laws, regulations and administrative 
provisions necessary to comply with this Directive. They shall 
forthwith communicate to the Commission the text of those 
provisions.  
Member States shall apply the provisions set out in the Annex 
to this Directive, except the obligations concerning the labelling 
set out in column (f) of entry 208, from 1 December 2010.  
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 determine 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  
Transitional provisions  
Member States shall take all necessary measures to ensure that 
after 1 November 2011 no cosmetic products which fail to 
comply with the obligations concerning the labelling set out 
in column (f) of entry 208 of Part I of Annex III to Directive 
76/768/EEC, as amended by this Directive, are placed on the 
market by Union manufacturers or by importers established 
within the Union.  
Member States shall take all necessary measures to ensure that 
after 1 November 2012 no cosmetic products which fail to 
comply with the obligations concerning the labelling set out 
in column (f) of entry 208 of Part I of Annex III to Directive 
76/768/EEC, as amended by this Directive, are sold or disposed 
of to the final consumer in the Union.EN 9.2.2010 Official Journal of the European Union L 36/21  
( 1 ) OJ L 262, 27.9.1976, p. 169.Article 4  
Entry into force  
This Directive shall enter into force on the 20th day following its publication in the  Official Journal of the 
European Union . 
Article 5  
Addressees  
This Directive is addressed to the Member States.  
Done at Brussels, 8 February 2010.  
For the Commission  
The President  
José Manuel BARROSOEN L 36/22 Official Journal of the European Union 9.2.2010ANNEX  
Annex III to Directive 76/768/EEC is amended as follows:  
1. in Part 1 the following entries are added:  
Reference 
number  Substance  Restrictions  
Conditions of use and warnings 
which must be printed on the 
label  Field of 
application 
and/or use  Maximum 
authorised 
concentration 
in the finished 
cosmetic 
product  Other limitations and 
requirements  
a b  c  d  e  f  
‘208  1-(beta- 
Aminoethyl)amino-4- 
(beta-hydro ­
xyethyl)oxy-2-nitro ­
benzene 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 nitro ­
samine content: 
50 μg/kg 
— Keep in nitrite- 
free containers
  Hair colourants 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.’  
209  2-[(2-methoxy-4-nitro ­
phenyl)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 nitro ­
samine content: 
50 μg/kg 
— Keep in nitrite- 
free containers  
2. in Part 2 the entries relating to reference Nos 26 and 29 are deleted.EN 9.2.2010 Official Journal of the European Union L 36/23