EN    EN EN EN 1   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Council Directive 76/768/EEC, concern ing cosmetic products, for the purpose 
of adapting Annexes II and V II 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 Products, Whereas: (1) The Scientific Committee on Consumer Products ("SCCP") concluded in its opinion of 
20 June 2006 that “ Although 4-aminobenzoic acid (PABA ) is presently permitted and 
used as a sunscreen, it became apparent in  the process of evalu ation of the dossier 
that much of the information did not c onform to current standards and guidelines”.  In 
order to carry out a proper risk assessment of 4-aminobenzoic acid the SCCP required 
a new dossier with additional safety data conform to modern standards and SCCP guidelines to be submitted by cosmetics industry before 1 July 2007.  
(2) The Commission received information from the cosmetics industry that there is no 
longer interest in using 4-aminobenzoic acid  in cosmetic products in the Community 
market. It appears that the cosmetics i ndustry does not intend to  defend the use of 
PABA as it has not submitted any additional safety data required by the opinion of the SCCP of 20 June 2006. 
(3) Without a proper risk assessment 4-aminobenzoi c acid can not be c onsidered safe for 
use as UV-filter in cosmetics and should therefore be deleted from Annex VII and 
listed in Annex II to Directive 76/768/EEC. 
(4) Regarding Diethylamino hydroxybenzoyl hexyl benzoate, the SCCP concluded in its 
opinion of 15 April 2008 that th e use of this substance at a maximum concentration of 
10% in cosmetic products, including sunscr een products, does not pose a risk to the 
                                                
 
1 OJ L 262, 27.9.1976, p. 169.  [ no longer necessary ] EN 2   EN consumer. In order to extend the scope of th e allowed use of this substance column "c" 
of entry 28 should be amended in Annex VII. 
(5) 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  
Annexes II and VII to Directive 76/768/EEC ar e amended in accordance with the Annex to 
this Directive. 
Article 2 
1. Member States shall adopt and publish, by [Day, Month, Year = Six 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 Commission th e text of those provisions and a 
correlation table between those pr ovisions and th is Directive. 
They shall apply the provisions set out in po int 3 of the Annex to this Directive from 
[Day, Month, Year = Six months after th e entry into force of the Directive] .  
They shall apply the provisions set out in  points 1 and 2 of the Annex to this 
Directive from [Day, Month, Year = 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. 
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 
 […] EN 3   EN  Member of the Commission EN 4   EN ANNEX  
Directive 76/768/EEC is amended as follows: 
(1) In Annex II, entry 167 “Esters of 4-am inobenzoic acid, with the free amino group,
 with the exception of that given in Annex VII, Part 2” is replaced by “4-
 aminobenzoic acid and its esters, with the free amino group”. 
(2) In Annex VII, entry 1 is deleted. (3) In Annex VII, in entry 28 the words “in sunscreen products” are deleted from
 column “c”.