EN    EN EN 
 EN    EN  EUROPEAN COMMISSION 
Brussels, 17.12.2009 
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending, for the purpose of adaptation to technical progress, Annex III to Council 
Directive 76/768/EEC concernin g cosmetic products  
 EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of  
amending, for the purpose of adaptation to technical progress, Annex III to Council 
Directive 76/768/EEC concernin g 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 Products, Whereas: (1) The Scientific Committee on Consumer Produc ts (SCCP), subsequently replaced by 
the Scientific Committee on Consumer Safety (SCCS) by Commission Decision 
2008/721/EC
2, concluded in its opinion of 2 October 2007  that the data included in the 
dossier demonstrate that polidoc anol (laureth-9) is of low toxicity and does not pose a 
risk to the health of the consumer when us ed up to 3% in leav e-on and up to 4% in 
rinse-off cosmetic products. As a result of this assessment, it should be included in Annex III to Directive 76/768/EEC. 
(2) Directive 76/768/EEC should therefore be amended accordingly. 
(3) 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. 
                                                
 
1 OJ L 262, 27.9.1976, p. 169. 
2 OJ L 241, 10.9.2008, p. 21. EN 3   EN 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 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 provi sions 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  
  
In Part 1 of Annex III to Directive 76/ 768/EEC, the following entry is added :  
Restrictions Reference 
number Substance 
Field of 
application 
and/or use Maximum 
authorised 
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 
x3 Polidocanol (INN) 
Laureth-9 (INCI)  
CAS No 3055-99-0 
EC No 221-284-4 Leave-on 
products 
 Rinse-off 
products 3.0% 
  
4.0%   
 
                                                 
3 MESSAGE FOR OPOCE NOT TO BE TRANSLATED! Please  replace x with the correct number which 
will appear in the consolidated version of  directive 76/768/EEC. Thank you very much!