Commission Directive 2007/53/EC of 29 August 2007 amending Council Directive 76/768/EEC concerning cosmetic products for the purposes of adapting Annex III thereto to technical progress (Text with EEA relevance )
Date: 2007-08-29
Institutions: European Commission
Subjects: chemical product, consumer information, cosmetic product, product safety, technological change

30.8.2007

EN

Official Journal of the European Union

L 226/19

DIRECTIVES

COMMISSION DIRECTIVE 2007/53/EC

of 29 August 2007

amending Council Directive 76/768/EEC concerning cosmetic products for the purposes of adapting
Annex III thereto to technical progress

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Article 2

Having regard to the Treaty
Community,

establishing the European

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,

consulting the Scientific Committee on Consumer

After
Products,

Whereas:

Fluorine compounds are currently listed in and subject to
restrictions and conditions laid down in Annex III, Part 1
of Directive 76/768/EEC. The Scientific Committee on
Consumer Products (SCCP) is of the opinion that if the
sole source of fluoride exposure is toothpaste containing
fluoride between 1 000 to 1 500 ppm,
there is a
minimal concern that children under the age of six will
develop fluorosis, provided that such toothpaste is used
as recommended. Therefore, reference numbers 26 to 43,
and reference numbers 47 and 56 of Annex III, Part 1
should be amended accordingly.

1. Member States shall adopt and publish, by 19 April 2008
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
together with a correlation table of those provisions and this
Directive.

They shall apply those provisions from 19 January 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
texts of the main provisions of domestic law which they adopt
in the field governed 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.

Directive 76/768/EEC should therefore be amended
accordingly.

Article 4

(1)

(2)

(3)

This Directive is addressed to the Member States.

Done at Brussels, 29 August 2007.

For the Commission

Günter VERHEUGEN
Vice-President

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

the

in this Directive are in
Standing
the

of

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex III of Directive 76/768/EEC is amended in accordance
with the Annex to this Directive.

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

last

amended by

Commission Directive 2007/22/EC (OJ L 101, 18.4.2007, p. 11).

L 226/20

EN

Official Journal of the European Union

30.8.2007

ANNEX

In reference numbers 26 to 43, and reference numbers 47 and 56 of Part 1 of Annex III to Directive 76/768/EEC, the
following text is added after each entry in column f:

‘For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children
(e.g. “for adult use only”) the following labelling is obligatory:

“Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case
of intake of fluoride from other sources consult a dentist or doctor.” ’