WRITTEN QUESTION P-1187/97 by Daniela Raschhofer (NI) to the Commission (21 March 1997)

Subject: Genetically modified maize

1. Who were the members of the Committees for Food, Animal Nutrition and Pesticides, and by whom were they appointed? On the basis of what criteria were individual members selected, and from which countries did they come?

2. How was the safety of genetically engineered maize investigated? What long-term effects were studied over what period for (a) humans, (b) animals and (c) the environment?

3. Did the Commission give the scientific committees any instructions on drawing up their reports? If so, what instructions? If not, why did the Commission give the scientific committees the task of confirming the safety of genetically engineered maize (SCAN report VI/1623/97)?

4. Did the Commission take account of the numerous warnings from environmental, agricultural and scientific quarters? Did any scientists take up minority standpoints within the committees? Did the Commission take them into account? If so, where are they recorded?

5. On the basis of what information does the Commission rule out the possibility that animals and humans could absorb genes through the food chain and that these genes could subsequently mutate into dangerous bacteria?

6. What is known about the triggering of allergies by bacterial genes and their safety in terms of human and animal health?

7. Can the possibility be ruled out that genes might be transferred through pollen to other plants nearby, thereby endangering the natural ecological balance?

8. What use did the investigations make of information provided by lobbyists? Were lobbyists involved in research work, and did they have any influence on its results?

9. How will the Commission respond to imports of unlabelled genetically engineered maize?

10. How will the Commission respond to the import ban for genetically engineered maize in Austria and Luxembourg?

Answer given by Mrs Bjerregaard on behalf of the Commission (15 May 1997)

1. The members of the scientific committees that examined the maize dossiers, their function and nationality have been published in the Official journal ((OJ C 218, 23.8.1995, as amended on 26 February 1996 (OJ C 74, 14.3.1997) for the scientific committee for food. )) ((OJ C 173, 25.6.1994, as amended on 27 September 1995 (OJ C 272, 18.10.1995) for the scientific committee for animal nutrition. )) ((OJ C 113, 4.5.1989 and OJ C 279, 7.11.1990 for the scientific committee for pesticides. )). The members of the scientific committees established at Community level are proposed by the Member States and chosen by the Commission on the basis of their scientific experience and expertise. According to the Commission decisions by which the scientific committees for food, animal nutrition and pesticides were established, the committees are free to draw up their opinions as appropriate.

3. Following the discussions at the Environment Council in June 1996 and the subsequent submission of further information by Austria, the Commission decided, in line with the precautionary principle, to have the scientific basis of its proposed measures validated before taking any decision concerning the placing on the market of the genetically modified maize notified by Ciba Geigy (now renamed Novartis). To that effect the Commission asked the scientific committees for food, animal nutrition and pesticides if there was any reason to believe that the genetic modification of the maize was likely to have any adverse effects on human health, animal health and the environment. The scientific committees were given all the available information (the full dossier submitted by the notifier, the comments and correspondence of the competent authorities, including additional information submitted by Austria and at a later stage by the United Kingdom).

2., 4. to 8. As already stated by the Commission during the parliamentary debate which took place on 7 April 1997, the three scientific committees examined in depth the Ciba-Geigy dossier and all the available information. In particular, they examined the possibility of any allergenic, toxic, anti-nutritional and environmental effects arising from the introduced genes in maize. The opinions of the three scientific committees which were delivered on 9 and 13 December 1996 were adopted unanimously and concluded that there was no reason to believe that there would be any adverse effect on human health, animal health and the environment associated with the genetic modification in maize. None of the committees found any scientific evidence of long term risks for human health, animal health and the environment. The opinions of the three committees were officially transmitted to Parliament on 20 February 1997.

9. The Commission will soon adopt a Commission regulation in the context of Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs ((OJ L 33, 8.2.1979. )). This will result in the application to foodstuffs containing genetically modified maize notified by Ciba-Geigy and authorised to be placed on the market under Directive 90/220/EEC ((OJ L 43, 14.2.1997. )), of the same labelling requirements as those foreseen by the recently adopted Regulation (EC) No 97/258 concerning novel foods and novel food ingredients ((OJ L 117, 8.5.1990. )).

10. On 14 February 1997 the Commission was formally informed by Austria that the use and sale of the maize in question had been provisionally prohibited by an ordinance in accordance with Article 16 of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. With its notification Austria submitted detailed scientific arguments justifying its action. The Commission transmitted these arguments to the three scientific committees that had originally examined the dossier with a request to examine whether the information submitted by Austria constitutes new relevant scientific evidence which had not been taken into account by the committees when adopting their opinions and whether this information would cause them to consider that the product in question constitutes a risk to human health or the environment.

On 17 March 1997 Luxembourg also informed the Commission of similar measures with respect to the Ciba-Geigy maize.

According to the Directive, Member States may provisionally prohibit the sale or use of a product which has been properly notified and received consent under the Directive if they have justifiable reasons to consider that the product constitutes a risk to human health or the environment. In such cases, a decision shall be taken on the matter within three months in accordance with the procedure under Article 21 of the Directive.

As foreseen by Article 16, the Commission will examine each case separately and submit for opinion as appropriate, to the regulatory committee established by Directive 90/220/EEC a draft of the measure to be taken.