31998Y0429(01)

Commission Communication on the ways in which the Commission is to protect the intellectual property in connection with the development and manufacture of flavouring substances covered by Regulation (EC) No 2232/96 of the European Parliament and of the Council (98/C 131/03) (Text with EEA relevance)

In this communication, the Commission sets out the ways in which it is to protect the intellectual property in connection with the development and manufacture of the flavouring substances covered by Regulation (EC) No 2232/96 of the European Parliament and 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 ways in which this protection should be conferred by the Member States (2) are covered in the recommendation of 21 April 1998 (3).

I. Need to protect intellectual property concerning certain flavouring substances

1. Under Article 3(1) of Regulation (EC) No 2232/96, the Member States must notify the Commission of the list of flavouring substances which may be used in or on foodstuffs marketed on their territory. These flavouring substances and the technical data relating to them are initially communicated to the competent authorities of the Member States by their manufacturers. Under Articles 3(2) and 4(1) of Regulation (EC) No 2232/96, this information can be entered in a register and evaluation programme made public. Throughout the Community procedure set up by the Regulation, a number of persons should have access to this information.

2. The circulation of some of this information should be restricted. The development of certain new flavouring substances and the manufacture of certain existing flavouring substances calls for heavy investment by the manufacturers in research and production. Flavouring substances which are not inventions cannot be patented. The development and manufacture of these flavouring substances nonetheless amount to trade secrets which have to be protected against acts of counterfeiting and unfair competition. The authors of Community legislation took account of this situation 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 manufacturer`. This need to protect intellectual property is also referred to in recital 14 of that Regulation. This requirement applies not only to flavouring substances notified pursuant to Article 3(1) of Regulation (EC) No 2232/96 but also in the future to new flavouring substances as referred to in Article 5(2) of the Regulation. This requirement applies at all stages of the Community procedure set up by the Regulation.

3. Intellectual property can be protected through the confidentiality of the technical data concerning the flavouring substances in question. It is necessary to define the ways in which confidential data is to be protected by the Commission.

II. Ways in which the protection of this confidential data is guaranteed by the Commission

1. At all stages of the Community procedure set up by Regulation (EC) No 2232/96, the Commission and the experts which assist it should take all the necessary steps to guarantee protection of the confidential information communicated by the manufacturers of flavouring substances or their representatives.

2. Such confidential information may cover:

- the nature of the flavouring substances, their origin and the manufacturing process,

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

- 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 the flavouring substances which may be used on its territory, it should clearly indicate which substances on that list and/or which data have to be protected. Having received the notification, the Commission then assigns a code number to the flavouring substances in question. The indication in a document of such code numbers in place of confidential information is sufficient to guarantee the confidentiality of such information. There is then no further need for this document to be the subject of protection under this communication. These provisions concern in particular the opinions on flavouring substances delivered by the Scientific Committee for Food.

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

5. At all stages of the procedure, the confidential data is accessible only to those persons in charge or directly involved in the administrative, technical or scientific processing of the dossier, namely:

- the officials and other employees of the Commission appointed ex officio by the Secretary-General of the Commission for the purposes of the procedure set up by Regulation (EC) No 2232/96 as well as the officials and other employees who may be involved in the official control of foodstuffs, also appointed ex officio by the Secretary-General of the Commission, and bound by the obligation of professional secrecy under Article 214 of the EC Treaty,

- the members of the Scientific Committee for Food and the experts chosen by that Committee to assist it, bound by the obligation of professional secrecy under Article 214 of the EC Treaty and/or Article 11 of Commission Decision 97/579/EC of 23 July 1997 setting up scientific committees in the field of consumer health and food safety (4),

- any other person not bound by the obligation of professional secrecy under national or Community law, but required to sign a declaration of confidentiality.

6. The bodies representing the manufacturers of flavouring substances consider it sufficient to protect confidential data on a flavouring substance for a period of five years. This period runs from the date on which the Commission receives the list containing the flavouring substance in question or any dossier concerning any new flavouring substance. The date on which this period expires should be entered in a register and in the evaluation programme.

(1) OJ L 299, 23.11.1996, p. 1.

(2) Reference in this communication to the Member States also covers the signatories to the EEA Agreement.

(3) OJ L 127, 29.4.1998.

(4) OJ L 237, 28.8.1997, p. 18.