DIRECTIVES
COMMISSION DIRECTIVE 2008/123/EC
of 18 December 2008
amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting
Annexes II and VII thereto to technical progress
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing 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 relatingto 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 Products (SCCP)
concluded in its opinion of 20 June 2006 that ‘Although
4-aminobenzoic acid (PABA) is presently permitted andused as a sunscreen, it became apparent in the process ofevaluation of the dossier that much of the informationdid not conform to current standards and guidelines ’.I n
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 andSCCP guidelines to be submitted by the cosmeticsindustry before 1 July 2007.
(2) The cosmetics industry did not submit any additionalsafety data as requested by the SCCP in its opinion of
20 June 2006.
(3) Without a proper risk assessment 4-aminobenzoic acid
can not be considered safe for use as a UV-filter incosmetics and should therefore be deleted from AnnexVII and listed in Annex II to Directive 76/768/EEC.
(4) Regarding Diethylamino Hydroxybenzoyl Hexyl Benzoate(INCI), the SCCP concluded in its opinion of 15 April2008 that the use of this substance at a maximumconcentration of 10 % in cosmetic products, including
sunscreen products, does not pose a risk to theconsumer. In order to extend the scope of the alloweduse of this substance column ‘c’of entry 28 should be
amended in Annex VII to Directive 76/768/EEC.
(5) The measures provided for in this Directive are inaccordance with the opinion of the StandingCommittee on Cosmetic Products,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annexes II and VII 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 8 July 2009 at
the latest, the laws, regulations and administrative provisionsnecessary to comply with this Directive. They shall forthwithcommunicate to the Commission the text of those provisions.
They shall apply the provisions set out in point 3 of the Annex
to this Directive from 8 July 2009.
They shall apply the provisions set out in points 1 and 2 of the
Annex to this Directive from 8 October 2009.
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. MemberStates 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 inthe field covered by this Directive.EN 19.12.2008 Official Journal of the European Union L 340/71
(1) OJ L 262, 27.9.1976, p. 169.Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the
European Union .
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 18 December 2008.
For the Commission
Günter VERHEUGEN
Vice-President
ANNEX
Directive 76/768/EEC is amended as follows:
1. In Annex II, entry 167 ‘Esters of 4-aminobenzoic 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’.EN L 340/72 Official Journal of the European Union 19.12.2008