Commission Directive 2004/88/EC of 7 September 2004 amending Council Directive 76/768/EEC concerning cosmetic products for the purpose of adapting Annex III thereto to technical progress Text with EEA relevance
Date: 2004-09-07
Institutions: European Commission
Subjects: European standard, application of EU law, cosmetic product, product safety, technological change

8.9.2004

EN

Official Journal of the European Union

L 287/5

COMMISSION DIRECTIVE 2004/88/EC

of 7 September 2004

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

(Text with EEA relevance)

(4)

(5)

(6)

is therefore necessary to include musk xylene and
It
musk ketone in part 1 of Annex III
to Directive
76/768/EEC while the corresponding entries in part 2
of that Annex should be deleted.

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

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

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 1 October 2004 at
latest. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

the

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.

Article 3

This Directive shall enter into force on the third day following
the European
that of
Union.

its publication in the Official

Journal of

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 7 September 2004.

For the Commission

Olli REHN
Member of the Commission

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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,

After consulting the Scientific Committee on Cosmetic Products
and Non-food Products intended for Consumers,

Whereas:

(1)

(2)

(3)

As the risk assessment had not been completed in
accordance with Council Regulation (EEC) 793/93 on
the risks of existing
the evaluation and control of
substances (2),
inclusion in part 2 of
Annex III
to Directive 76/768/EEC for musk xylene
and musk ketone was extended until 30 September
2004.

the period of

On 8 January 2004,
the Scientific Committee on
Toxicity, Ecotoxicity and the Environment adopted an
opinion on the results of the risk assessment of musk
in
xylene and musk ketone that was carried out
accordance with Regulation (EEC) 793/93.

The Scientific Committee on Cosmetic Products and
Non-food Products intended for Consumers (SCCNFP)
has confirmed that musk xylene can be safely used in
cosmetic products, excluding oral care products, up to a
maximum concentration in the final product of 1 % in
fine fragrance, 0,4 % in eau de toilette and 0,03 % in
other products and that musk ketone can be safely
used
care
products,
products, up to a maximum concentration in the final
product of 1,4 % in fine fragrance, 0,56 % in eau de
toilette and 0,042 % in other products.

excluding

cosmetic

oral

in

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2003/83/EC (OJ L 238, 25.9.2003, p. 23).
(2) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC)

No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

L 287/6

EN

Official Journal of the European Union

8.9.2004

ANNEX

Annex III to Directive 76/768/EEC is amended as follows:

1. In part 2, the entries under reference numbers 61 and 62 are deleted.

2. In part 1, the following entries are added as reference numbers 96 and 97:

Reference number

Substance

Field of application and/or use

Maximum authorised
concentration in the finished
cosmetic product

Other
limitations and
requirements

Conditions of use and
warnings which must be
printed on the label

Restrictions

a
‘96

97

b

c

d

e

f

Musk xylene (CAS No
81-15-2)

All cosmetic products, with
the exception of oral care
products

(a) 1,0 % in fine fragrance
(b) 0,4 % in eau de toilette
other
(c) 0,03 %

in

ketone

Musk
No 81-14-1)

(CAS

All cosmetic products, with
the exception of oral care
products

products

(a) 1,4 % in fine fragrance
(b) 0,56 % in eau de toilette
(c) 0,042 %
other
products’

in