WRITTEN QUESTION E-3442/00

by Monica Frassoni (Verts/ALE) to the Commission

(7 November 2000)

Subject: Italian gene food ban

The Commission has submitted a draft Decision requiring the Italian government to cancel its decree of 4 August 2000 banning the marketing and use of four genetically engineered maize products notified under Articles 3(4) and 5 of the Novel Food Regulation 258/97(1).

Italy has stated that in its opinion these products are not substantially equivalent and therefore should be the subject of a full safety assessment and authorisation procedure.

In the draft opinion of the rapporteur for the Scientific Committee on Food (Professor Grunow) he states that additional evidence for safety would be considered desirable if the products would undergo a re-evaluation and explains that the current guidelines would require a different approach to that originally applied by the UK competent authority and the Scientific Committee on Plants. He says indeed that the Committee points out that the ACNFP has not distinguished between total and partial substantial equivalence as it has been done in the SCF Guidelines for the Assessment of Novel Foods and that in contrast to the ACNFP the Committee would apply these Guidelines.

Will the Commission please explain:

1. Why these comments were suppressed in the final published opinion of the SCF?

2. Why, in the interests of precaution, the Commission has not ordered a full re-evaluation of the dossiers?

3. Whether, in the light of continuing public concern about the use of GMOs in the food chain and advances in biochemical and toxicological testing, the largely discredited substantial equivalence concept, which simply tests for compositional analysis, should now be abandoned?

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

Answer given by Mr Byrne on behalf of the Commission

(20 December 2000)

1. Draft opinions are prepared for scientific debate by the scientific committee on food. They may undergo modification before final adoption and cannot be taken as expressing the views of the scientific committee on food. In this particular case all members, including the rapporteur of the initial draft, supported and adopted the final text published as the opinion of the scientific committee on food.

2. The products in question have undergone safety assessments carried out by the British advisory committee for novel foods and processes (ACNFP). Furthermore, in its opinion of 7 September 2000, the scientific committee on food concluded that the information provided by the Italian authorities does not provide detailed scientific grounds for considering that the use of the novel foods in question endangers human health.

This is in accordance with the report provided by the Istituto Superiore di Sanitá which concludes, that, in the present state of scientific information, there is no evidence that consumption of derivatives of the four genetically modified organisms (GMOs) poses a risk to human or animal health.

The Commission is not aware of scientific documentation identifying potentially hazardous effects, which could form the basis of a re-evaluation.

3. The concept of substantial equivalence comprises a whole range of scientific considerations, and not only compositional analysis. It is considered to be a useful element in risk assessment of novel foods.

In the context of the review of the Regulation (EC) No 258/97 of the Parliament and of the Council of 27 January 1997, concerning novel foods and novel food ingredients, which is foreseen for next year, the Commission intends to reconsider whether it is appropriate that genetically modified (GM) derived foods and food ingredients benefit from the notification procedure.