DIRECTIVES  
COMMISSION DIRECTIVE 2010/3/EU  
of 1 February 2010  
amending, for the purpose of adaptation to technical progress, Annexes III and VI to Council 
Directive 76/768/EEC concerning cosmetic products  
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) The Scientific Committee on Consumer Products (SCCP), 
subsequently replaced by the Scientific Committee on 
Consumer Safety (SCCS) by Commission Decision 
2008/721/EC (  2 ), concluded in its opinion of 15 April 
2008 that Ethyl Lauroyl Arginate HCl is safe for the 
consumers, when used up to a maximum authorised 
concentration of 0,8 % in soap, anti-dandruff 
shampoos, and non-spray deodorants. It should 
therefore be included in Annex III to Directive 
76/768/EEC.  
(2) The SCCP concluded in the same opinion that Ethyl 
Lauroyl Arginate HCl is safe for the consumers, when 
used up to a maximum authorised concentration of 
0,4 % as a preservative in cosmetic products. However, 
the Committee considered that it should not be used in 
lip products, oral products and spray due to mucosal and 
respiratory tract irritation potential. It should therefore be 
included along with these restrictions in Annex VI to 
Directive 76/768/EEC.  
(3) Directive 76/768/EEC should therefore be amended 
accordingly.  (4) 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  
Annexes III and VI to Directive 76/768/EEC are amended in 
accordance with the Annex to this Directive.  
Article 2  
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.  
They shall apply those provisions from 1 March 2011.  
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  
This Directive shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union .EN 2.2.2010 Official Journal of the European Union L 29/5  
( 1 ) OJ L 262, 27.9.1976, p. 169.  
( 2 ) OJ L 241, 10.9.2008, p. 21.Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 1 February 2010.  
For the Commission  
The President  
José Manuel BARROSOEN L 29/6 Official Journal of the European Union 2.2.2010ANNEX  
1. In the table set out in Part 1 of Annex III to Directive 76/768/EEC, the following entry is 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  
‘207  Ethyl Lauroyl Arginate 
HCl (INCI) (*) 
Ethyl- Ν α -dodecanoyl- 
L-arginate hydrochloride 
CAS No 60372-77-2 
EC No 434-630-6  (a) soap 
(b) anti-dandruff 
shampoos 
(c) deodorants, not 
in form of 
spray  0,8 %  For purposes other 
than inhibiting the 
development of 
micro-organisms in 
the product. This 
purpose has to be 
apparent from the 
presentation of the 
product.  
(*) For use as a preservative, see Annex VI, Part 1, entry No 58.’  
2. In the table set out in Part 1 of Annex VI to Directive 76/768/EEC, the following entry is added:  
Reference number  Substance  Maximum authorised 
concentration  Limitations and requirements  Conditions of use and 
warnings which must be 
printed on the label  
a b  c  d  e  
‘58 Ethyl Lauroyl Arginate 
HCl (INCI) (*) (**) 
Ethyl- Ν α -dodecanoyl- 
L-arginate hydrochloride 
CAS No 60372-77-2 
EC No 434-630-6  0,4 %  Not to be used in 
lip products, oral 
products and spray 
products.  
(**) For other uses than preservatives, see Annex III, Part I, entry No 207.’EN 2.2.2010 Official Journal of the European Union L 29/7