Twenty-second Commission Directive 98/16/EC of 5 March 1998 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)
Date: 1998-03-05
Institutions: European Commission
Subjects: approximation of laws, cosmetic product, marketing, offal, product safety, technological change

L 77/44

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Official Journal of the European Communities

14. 3. 98

TWENTY-SECOND COMMISSION DIRECTIVE 98/16/EC

of 5 March 1998

adapting to technical progress Annexes II, III, VI and VII to Council Directive
76/768/EEC on the approximation of the laws of the Member States relating to
cosmetic products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 76/768/EEC of 27
July 1976 (1) on the approximation of the laws of the
Member States relating to cosmetic products, as last
amended by Commission Directive 97/45/EC (2), and in
particular Article 8(2) thereof,

Whereas Commission Directive 97/1/EC (3) temporarily
prohibited, as a precautionary measure, the use of bovine,
ovine and caprine tissues and fluids from the encephalon,
the spinal cord and the eyes, and ingredients derived
therefrom; this Directive was to be reviewed following the
examination of the elements on which it was based, and
generally adapted in the light of
the development of
scientific knowledge;

Whereas Commission Decision 97/534/EC of 30 July
1997 on the prohibition of the use of material presenting
risks as
transmissible spongiform encephalo-
pathies (4), defines specified risk materials, provides for
their elimination at source and prohibits their import into
the Community;

regards

Whereas Directive 76/768/EEC requires Member States to
ensure that only cosmetic products which conform to the
provisions of this Directive may be put on the market in
the EU and whereas, more particularly, Member States
shall prohibit the marketing of cosmetic products con-
taining substances listed in Annex II;

Whereas these provisions apply to all cosmetic products
to be placed on the market in the Community, nothwith-
standing the origin of the product or the raw materials
contained therein; whereas, thereby, the compliance with
Community law of cosmetic products, starting materials
and intermediate products which are imported into the
Community to be used in the manufacture of cosmetic
products is controlled and checked;

Whereas Directive 76/768/EEC should be amended to
align the list of prohibited animal materials to that
contained in the Decision 97/534/EC;

(1) OJ L 262, 27. 9. 1976, p. 169.
(2) OJ L 196, 24. 7. 1997, p. 77.
(3) OJ L 16, 18. 1. 1997, p. 85.
(4) OJ L 216, 8. 8. 1997, p. 95.

Whereas the opinion of
the Scientific Committee on
Cosmetology of 24 June 1997 stated that tallow deriv-
atives such as fatty acids, glycerine, fatty acid esters and
soaps, used in the production of cosmetic products, are
considered safe provided that, as a minimum, they have
been obtained by certain specified methods which have
been strictly certified, and that other tallow derivatives
such as fatty alcohols and fatty amides produced from the
abovementioned derivatives and subsequently processed
are regarded as safe;

scientific opinion,

Whereas, according to this
is
possible to grant a derogation for tallow derivatives; this
derogation also applies to other derivatives of tallow such
as fatty alcohols, fatty amines and fatty amides, and ma-
terials made from the abovementioned that are manufac-
tured according to the methods indicated in the Annex
and subjected to additional subsequent treatments;

it

Whereas the measures provided for in this Directive are
in accordance with the opinion of the Committee on the
Adaptation to Technical Progress of the Directives on the
removal of technical barriers to trade in the cosmetic
products sector;

Whereas Member States have the right to maintain in
force until 1 April 1998 those measures adopted in con-
cordance with Directive 97/1/EC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 76/768/EEC is hereby amended as shown in the
Annex.

Article 2

Member States shall take the necessary measures to ensure
that the cosmetic products containing the substances set
out in the Annex cannot be placed on the market from 1
April 1998. This does not apply to products produced
before 1 April 1998. Member States may retain in force
those measures implementing Directive 97/1/EC until
1 April 1998.

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Article 3

Article 4

1. Member States shall bring into force the laws, regu-
lations and administrative provisions necessary to comply
with this Directive no later than 1 April 1998. They shall
forthwith inform the Commission thereof.

When Member States adopt these provisions, these shall
contain a reference to this Directive or shall be accom-
panied by such reference at the time of their official pub-
lication. The procedure for
such reference shall be
adopted by the Member States.

2. Member States shall communicate to the Commis-
sion the provisions of national law which they adopt in
the field covered by this Directive.

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 5 March 1998.

For the Commission

Martin BANGEMANN

Member of the Commission

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ANNEX

Reference number 419 of Annex II to Directive 76/768/CEE is amended as follows:

‘419.

(a) the skull, including the brain and eyes, tonsils and spinal cord of:

— bonive animals aged 12 months,

— ovine and caprine animals which are aged over 12 months or have a permanent incissor

tooth erupted through the gum;

(b) the spleens of ovine and caprine animals and ingredients derived therefrom.

However, tallow derivatives may be used provided that the following methods have been used
and strictly certified by the producer:
— Transesterification or Hydrolysis at at least: 200 HC, 40 bars (40,000 hPa) for 20 minutes

(glycerol and fatty acids and esters),

— Saponification with NaOH 12M (glycerol and soap):

— Batch process: at 95 HC for three hours

or

— Continuous process: at 140 HC, two bars (2000 hPa) for eight minutes or equivalent

conditions.’