98/282/EC: Commission Recommendation of 21 April 1998 on the ways in which the Member States and the signatory States to the Agreement on the European Economic Area should protect intellectual property in connection with the development and manufacture of flavouring substances referred to in Regulation (EC) No 2232/96 of the European Parliament and of the Council (Text with EEA relevance)
Date: 1998-04-21
Institutions: European Commission
Subjects: confidentiality, flavouring, food inspection, food production, foodstuff, intellectual property

L 127/32

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Official Journal of the European Communities

29. 4. 98

COMMISSION RECOMMENDATION

of 21 April 1998

on the ways in which the Member States and the signatory States to the
Agreement on the European Economic Area should protect intellectual property
in connection with the development and manufacture of flavouring substances
referred to in Regulation (EC) No 2232/96 of the European Parliament and of the
Council

(Text with EEA relevance)

(98/282/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
the second indent of
Community, and in particular
Article 155 thereof,

Whereas pursuant to Article 3(1) of Regulation (EC) No
2232/96 of the European Parliament and of the Council
of 28 October 1996 laying down a Community procedure
for flavouring substances used or intended for use in or
on foodstuffs (1), the Member States (2) must notify the
Commission of the list of flavouring substances which
may be used in or on foodstuffs marketed on their terri-
tory; whereas these flavouring substances and the tech-
nical data relating to them are initially communicated to
the competent authorities of the Member States by their
manufacturer; whereas under the first subparagraph of
Article 3(2) and Article 4(1) of Regulation (EC) No
2232/96 this information may be entered in a register and
in an evaluation programme made public; whereas, more-
over, a number of persons should have access to this
information throughout the Community procedure set up
by the Regulation;

Whereas, however, the circulation of some of this infor-
mation should be restricted; whereas the development of
certain new flavouring substances and the manufacture of
certain existing flavouring substances calls
for heavy
investment by manufacturers in research and production;
whereas flavouring substances which are not inventions
cannot be patented; whereas the development and manu-
facture of such flavouring substances nonetheless amount
to trade secrets which have to be protected against acts of
counterfeiting and unfair competition;

Whereas the Community legislature has taken account of
this fact by requiring in the second subparagraph of
Article 3(2) of Regulation (EC) No 2232/96 that these
flavouring substances be ‘designated in such a way as to
protect the intellectual property rights of their manufac-
turer’; whereas this need to protect intellectual property is
also referred to in recital 14 of the preamble to that Regu-
lation; whereas this requirement applies not only to

(1) OJ L 299, 23. 11. 1996, p. 1.
(2) In this recommendation, reference to the Member States also

covers the signatories to the EEA Agreement.

flavouring substances notified pursuant to Article 3(1) of
the Regulation but also in the future to new flavouring
substances as referred to in Article 5(2) thereof; whereas
this requirement applies at all stages of the Community
procedure set up by the Regulation;

Whereas intellectual property can be protected through
the confidentiality of the technical data concerning the
flavouring substances in question; whereas it is necessary
to define the ways in which such confidential data should
be protected by the Member States; whereas these ways
can be defined by way of a Commission recommendation
addressed to the Member States; whereas the ways in
to be protected by the
which confidential data is
Commission are described in the communication of 21
April 1998 (3);

Whereas the bodies representing the manufacturers of
flavouring substances consider
to protect
it sufficient
confidential data for a period of five years;

Whereas the Member States have been consulted on this
recommendation within the framework of the Standing
Committee on Foodstuffs,

HEREBY FORMULATES THIS RECOMMENDATION:

1. Protection of the confidential data concerning a fla-
vouring substance should be provided at the express
request of the manufacturer of the flavouring substance
in question, or his representative, made to the com-
petent authorities of the Member State on whose terri-
tory the flavouring substance may be used. The
Member State should examine each case to see
whether or not such protection should be provided.

2. This confidential information may cover:

— the nature of the flavouring substances, their origin

and the manufacturing process involved,

— the conditions as to the use of

the flavouring
substances, including the names of the foodstuffs
in or on which they may be used,

(3) OJ C 131, 29. 4. 1998, p. 3.

29. 4. 98

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Official Journal of the European Communities

L 127/33

— all the information which is not generally known
to persons belonging to the circles normally
dealing with the type of information in question or
which is not easily accessible to them and has a
commercial value.

3. Where the Member State notifies to the Commission a
list of flavouring substances which may be used on its
territory, is should clearly indicate which substances on
that list and/or which data have to be protected.

4. The need to protect confidential data extends to all
stages of the procedure set up by Regulation (EC) No
2232/96, and particularly in the following three areas:
the possession of information, its dissemination and its
processing. It is for the administrations concerned to
provide such protection at their own level in each of
these areas by the appropriate means (security of the
premises where such data is held, security of document
by
transmission,
whatever means and of the persons for whom those
copies are intended, confidentiality of
translations,
etc.).

identification of

copies made

5. At all stages of the procedure, the confidential data
should be accessible only to those persons in charge or
directly involved in the administrative, technical or
scientific processing of the dossier, namely the offi-
cials, other employees and experts of the competent
authorities of each Member State required to have a
knowledge of dossiers from that Member State and

possibly of dossiers from other Member States through
meetings or exchanges of information. Such persons
are bound by the obligation of professional secrecy
under their national
law or Article 214 of the EC
Treaty. The confidential data should also be accessible
to officials and other employees of the Member States
responsible for the official control of foodstuffs and
bound by the obligation of professional secrecy under
their national law or Article 12 of Council Directive
89/397/EEC of 14 June 1989 on the official control of
foodstuffs (1). Any other person having access to the
confidential data but not bound by the obligation of
professional secrecy under national or Community law
should be required to sign a declaration of confidenti-
ality.

6. Confidential data relating to flavouring substances
should be protected for a period of five years from the
date of receipt by the Commission of the list notified
by the Member State and containing the flavouring
substance in question or of any dossier concerning a
new flavouring substance.

Done at Brussels, 21 April 1998.

For the Commission

Martin BANGEMANN

Member of the Commission

(1) OJ L 186, 30. 6. 1989, p. 23.