WRITTEN QUESTION P-2745/98

by Hiltrud Breyer (V) to the Commission

(1 September 1998)

Subject: Novel Foods Regulation (EC) 258/97 - authorisation of varieties

1. Is it true that, if genetically modified plants are registered in the common catalogue of varieties of agricultural plant species (70/457/EEC)(1) and of vegetable seed (70/458/EEC)(2), no further approval is required for these plants under the Novel Foods Regulation (258/97)(3)?

2. If that is the case, will only the labelling of such plants be covered by the Novel Foods Regulation?

3. In future, will transgenic plants still require any authorisation and approval apart from registration in the common catalogue of varieties?

4. Is it true that all plant products which are authorised as varieties will no longer need to undergo any notification procedure or the simplified authorisation procedure under the Novel Foods Regulation?

5. If so, will any products processed from such plants require authorisation under the Novel Foods Regulation?

6. Will secondary products of plants already covered by variety authorisation need to be individually notified, tested and authorised under the Novel Foods Regulation?

7. Will secondary products which contain only a small percentage of plant products requiring authorisation need separate authorisation (e.g., tomato concentrate on ready-made pizzas)?

I find totally unacceptable the answers given by the Commission to Written Questions E-2113/97 to E-2121/97(4). Not a single question has been answered. The Commission has simply referred to legal acts of which I am also aware. The Commission must, however, realise that the text of the legal acts does not provide the answer to my questions. I would therefore ask the Commission to stop prevaricating and give specific answers to my questions.

Answer given by Mr Bangemann on behalf of the Commission

(16 October 1998)

1. At present, the varieties covered by Directive 70/457/EEC on the common catalogue of varieties of agricultural plant species and Directive 70/458/EEC on the marketing of vegetable seed must be registered in the catalogue of varieties whether or not they are genetically modified (GMOs), with a view to the placing on the market of seeds or plants within the Community. Before they can be registered, evidence must be provided that they are distinct, stable and sufficiently uniform, and, with regard to varieties of agricultural plant species, that they will be of satisfactory value for cultivation and use.

Varieties based on GMOs are also subject to a special authorization under a separate procedure following an assessment of the risks they could pose to human health and the environment within the meaning of Council Directive 90/220/EEC(5) on the deliberate release into the environment of genetically modified organisms.

Moreover, since 15 May 1997, any food or food ingredient derived from a transgenic variety which had not been consumed in significant quantities in the Community at that time, has had to conform with the procedures of Regulation (EC) 258/97 concerning novel foods and novel food ingredients before it can be placed on the market.

2. Seeds and plants of transgenic varieties are labelled in accordance with the provisions of Directives 70/457/EEC and 70/458/EEC respectively, and in accordance with the terms of Annex III to Directive 90/220/EEC which states that any product containing or comprising GMOs, which is the case with transgenic varieties, must be labelled as such.

Foods or food ingredients based on transgenic varieties are subject to the labelling requirements under Article 8 of Regulation (EC) 258/97 which stipulates that the consumer must be informed of:

- any characteristic or food property such as composition, nutritional value or nutritional effects, or the intended use of the food which renders a novel food or food ingredient no longer equivalent to an existing food or food ingredient. A novel food or food ingredient shall be deemed to be no longer equivalent if scientific assessment, based upon an appropriate analysis of existing data, can demonstrate that the characteristics assessed are different in comparison with a conventional food or food ingredient, having regard to the accepted limits of natural variations for such characteristics. In this case, the labelling must indicate the characteristics or properties modified, together with the method by which that characteristic or property was obtained;

- the presence in the novel food or food ingredient of material which is not present in an existing equivalent foodstuff and which gives rise to ethical concerns or may have implications for the health of certain sections of the population;

- the presence of a GMO must be declared on the label.

3. The Commission has presented a proposal for an amendment of Directive 70/457/EEC on the common catalogue of varieties of agricultural plant species and Directive 70/458/EEC on the marketing of vegetable seed in line with the principle of a "one-stop shop". Parliament gave an opinion on the proposal in its July 1997 plenary session.

The principle of the "one-stop shop" establishes a link between different Community instruments in the field of biotechnology and also provides for a limitation of evaluations in the framework of sectoral legislation (for example Directives 70/457/EEC and 70/458/EEC or the Novel Foods Regulation) by taking account of any evaluations carried out under horizontal legislation (for example Directive 90/220/EEC) without having to repeat them.

In future, when Directives 70/457/EEC and 70/458/EEC are amended in line with the abovementioned principle, the evaluation of environmental risks within the meaning of Directive 90/220/EEC posed by transgenic varieties of species covered by the Directives will be carried out in connection with registering the varieties in the catalogue.

4. and 5. The amendment referred to under point 3 above also means that the placing on the market of foods or food ingredients produced from transgenic varieties and intended for use as foods or food ingredients within the meaning of Regulation (EC) 258/97 could be authorized under that Regulation, or under the procedure of Directives 70/457/EEC and 70/458/EEC for establishing that a food is harmless, similar to that already provided for in Regulation (EC) 258/97. In the latter case, and once all the evaluations (agricultural, environmental, harmlessness of food) have been carried out, the registration of the variety will authorize its cultivation, but also the processing and consumption of foods or food ingredients derived from it.

6. Derived products are subject to Regulation (EC) 258/97.

7. No, provided the vegetable products requiring authorization were authorized.

(1) OJ L 225, 12.10.1970, p. 1.

(2) OJ L 225, 12.10.1970, p. 7.

(3) OJ L 43, 14.2.1997, p. 1.

(4) OJ C 174, 8.6.1998, p. 11.

(5) OJ L 117, 8.5.1990.