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)
Date: 2008-12-18
Institutions: European Commission
Subjects: approximation of laws, chemistry, consumer protection, cosmetic product, dyestuffs industry, product safety

19.12.2008

EN

Official Journal of the European Union

L 340/71

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
Community,

establishing the European

including
concentration of 10 % in cosmetic products,
sunscreen products, does not pose a risk to the
consumer. In order to extend the scope of the allowed
use of this substance column ‘c’ of entry 28 should be
amended in Annex VII to Directive 76/768/EEC.

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,

(5)

The measures provided for
accordance with
opinion
Committee on Cosmetic Products,

the

in this Directive are in
Standing
the

of

consulting the Scientific Committee on Consumer

After
Products,

HAS ADOPTED THIS DIRECTIVE:

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
evaluation of the dossier that much of the information
did not conform to current standards and guidelines’. In
order to carry out a proper risk assessment of 4-amino­
benzoic acid the SCCP required a new dossier with ad­
ditional safety data conform to modern standards and
SCCP guidelines
to be submitted by the cosmetics
industry before 1 July 2007.

(2)

The cosmetics industry did not submit any additional
safety 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 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
(INCI), the SCCP concluded in its opinion of 15 April
this substance at a maximum
2008 that

the use of

(1) OJ L 262, 27.9.1976, p. 169.

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 provisions
necessary to comply with this Directive. They shall forthwith
communicate 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. 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.

L 340/72

EN

Official Journal of the European Union

19.12.2008

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

Article 3

This Directive is addressed to the Member States.

Article 4

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’.