Commission Directive 2003/16/EC of 19 February 2003 adapting to technical progress Annex III to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
Date: 2003-02-19
Institutions: European Commission
Subjects: analytical chemistry, approximation of laws, consumer protection, cosmetic product, product safety

L 46/24

EN

Official Journal of the European Union

20.2.2003

COMMISSION DIRECTIVE 2003/16/EC

of 19 February 2003

adapting to technical progress Annex III to Council Directive 76/768/EEC on the approximation of
the laws of the Member States relating to cosmetic products

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

HAS DECIDED AS FOLLOWS:

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
relating to cosmetic products (1), as last amended by Commis-
sion Directive 2003/1/EC (2), and in particular Article 8(2)
thereof,

After consulting the Scientific Committee on Cosmetic Products
and Non-food Products Intended for Consumers (SCCNFP),

Whereas:

(1)

(2)

(3)

(4)

(5)

The Scientific Committee for Cosmetic Products and
Non-food Products Intended for Consumers (SCCNFP)
recommends that musk xylene can be safely used in
cosmetic products, excluding oral care products, up to a
maximum daily theoretically absorbed dose of about
10µg/kg/day.

The SCCNFP recommends that musk ketone can be
safely used in cosmetic products, excluding oral care
products, up to a maximum daily theoretically absorbed
dose of about 14µg/kg/day.

Pending completion of the risk assessment of these two
substances in accordance with Council Regulation (EEC)
No 793/93 of 23 March 1993 on the evaluation and
control of the risks of existing substances (3), these two
substances have been provisionally included, until 28
February 2003, in Part 2 of Annex III to Directive 76/
768/EEC.

The risk assessment has not yet been completed in
accordance with the abovementioned Regulation. There-
fore, the period of inclusion of musk xylene and musk
ketone in Part 2 of Annex III to Directive 76/768/EEC
should be extended.

The measures provided for in this Directive are in accor-
dance with the opinion of the Committee for the adapta-
tion to technical progress of Directives on the removal
of technical barriers to trade in the cosmetic products
sector,

Article 1

The date ‘28.2.2003’ is replaced by ‘30.9.2004’ for reference
numbers 61 and 62 in Part 2, column g, of Annex III to Direc-
tive 76/768/EEC.

Article 2

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Direc-
tive by 28 February 2003 at the latest. They shall forthwith
inform the Commission thereof.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Article 3

This Directive shall enter into force on the third 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, 19 February 2003.

For the Commission

Erkki LIIKANEN

Member of the Commission

(1) OJ L 262, 27.9.1976, p. 169.
(2) OJ L 5, 10.1.2003, p. 14.
(3) OJ L 84, 5.4.1993, p. 1.