Commission Directive 2005/42/EC of 20 June 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II, IV and VI thereto to technical progress   (Text with EEA relevance)
Date: 2005-06-20
Institutions: European Commission
Subjects: consumer protection, cosmetic product, dyestuffs industry, product safety

21.6.2005

EN

Official Journal of the European Union

L 158/17

COMMISSION DIRECTIVE 2005/42/EC

of 20 June 2005

amending Council Directive 76/768/EEC, concerning cosmetic products,

for the purposes of

adapting Annexes II, IV and VI thereto to technical progress

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

number 53 in Part 1 of Annex VI
76/768/EEC should therefore be amended accordingly.

to Directive

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:

(4)

(5)

(6)

The SCCNFP is of the opinion that Methylisothiazolinone
does not pose a risk to the health of consumers if
employed in finished cosmetic products as a preservative
up to a concentration of 0,01 %. Methylisothiazolinone
should therefore be included in Part 1 of Annex VI to
Directive 76/768/EEC as reference number 57.

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

(1)

(2)

(3)

On the basis of the assessment of the cutaneous toxicities
(Saussurea lappa Clarke), 7-Ethoxy-4-
of costus root oil
methylcoumarin, hexahydrocoumarin and peru balsam
the Scientific Committee on
(Myroxylon pereirae),
Cosmetic Products and Non-Food Products intended for
Consumers
those
substances should not be used as fragrance ingredients
in cosmetic products. They should therefore be included
in Annex II to Directive 76/768/EEC.

the opinion that

(SCCNFP)

is of

in Part 1 of Annex

Azo-dyes CI 12150, CI 20170 and CI 27290 are
IV to Directive
included
76/768/EEC as colouring agents which are allowed for
use in cosmetic products. The safety of those colorants
has been questioned on the ground that they may form
carcinogenic amines during metabolism. The SCCNFP is
of the opinion, based on the available information, that
the use of the colorants CI 12150, CI 20170 and CI
27290 poses a risk to the health of the consumer as
they may release one or more carcinogenic aromatic
amines. Those colorants should therefore be excluded
from Part 1 of Annex IV to Directive 76/768/EEC.

Benzethonium chloride is included as reference number
53 in Part 1 of Annex VI to Directive 76/768/EEC as a
preservative which may be
employed in rinse-off
cosmetic products up to a concentration of 0,1 %. It is
the opinion of the SCCNFP that Benzethonium chloride
should also be allowed to be employed in leave-on
cosmetic products other than for oral care use up to a
concentration of 0,1 %. The entry under the reference

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2005/9/EC (OJ L 27, 29.1.2005, p. 46).

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes II, IV and VI to Directive 76/768/EEC are amended in
accordance with the Annex to this Directive.

Article 2

Member States shall take the necessary measures to ensure that
from 31 March 2006 cosmetic products which fail to comply
with Annexes II and IV of Directive 76/768/EEC as amended by
this Directive are not placed on the market by Community
manufacturers
the
importers
Community, nor sold or disposed of to the final consumer.

established within

by

or

Article 3

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
the latest. They shall
Directive by 31 December 2005 at
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

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.

L 158/18

EN

Official Journal of the European Union

21.6.2005

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 5

This Directive is addressed to the Member States.

Article 4

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

Done at Brussels, 20 June 2005.

For the Commission

Günter VERHEUGEN
Vice-President

21.6.2005

EN

Official Journal of the European Union

L 158/19

ANNEX

The Annexes to Directive 76/768/EEC are amended as follows:

1.

in Annex II, the following reference numbers are added:

‘1133. Costus root oil (Saussurea lappa Clarke) (CAS No 8023-88-9), when used as a fragrance ingredient

1134. 7-Ethoxy-4-methylcoumarin (CAS No 87-05-8), when used as a fragrance ingredient

1135. Hexahydrocoumarin (CAS No 700-82-3), when used as a fragrance ingredient

1136. Peru balsam (INCI name: Myroxylon pereirae; CAS No 8007-00-9), when used as a fragrance ingredient’

2.

in Part 1 of Annex IV, colouring agents CI 12150, CI 20170 and CI 27290 are deleted.

3. Part 1 of Annex VI is amended as follows:

(a)

the reference number 53 is replaced by the following:

Reference
number

Substance

Maximum
authorised
concentration

Limitations and requirements

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

a

b

c

d

e

‘53

Benzethonium
Chloride (INCI)

0,1 %

(a) Rinse-off products,

(b) Leave-on products other

oral care use’

than for

(b) the following entry is added as reference number 57:

Reference
number

Substance

a

b

‘57

Methylisothia-
zolinone (INCI)

Maximum
authorised
concentration

c

0,01 %’

Limitations and requirements

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

d

e