91998E3365(01)

WRITTEN QUESTION P-3365/98

by Paul Lannoye (V) to the Commission

(4 November 1998)

Subject: GMO marketing approval dossier: C/NL/96/10, Directive 90/220/EEC

The Scientific Committee on Plants has delivered a negative opinion on Avebe's application for marketing information for a transgenic potato. It concludes that without an adequate risk assessment of the potential consequences of horizontal gene transfer from the GM plants to humans, animals and the environment ... it is not possible to fully assess the safety of the transgenic potato lines.

1. Is this in fact the same issue on which the UK advisory committee ACRE, reached the conclusion that "the additional genes did not pose a risk to human health and the environment"?

2. Were the same facts available to both committees and the same risk assessment criteria applied?

3. Which antibiotic-resistant genes are involved? ACRE refers to kanamycin, the SCP refers to amikacin?

4. Given the provisions of Article 19(4) of Directive 90/220 (EEC)(1) which lays down "that in no case should the description of the GMO or the evaluation of foreseeable effects including pathogenic and/or ecologically disruptive effects be kept confidential" does the Commission now consider it to be in the public interest to publish the marketing application in full and the complete text of the SCP's opinion?

Answer given by Mrs Bonino on behalf of the Commission

(11 February 1999)

The opinion issued by the scientific committee on plants on 2 October 1998 on the AVEBE modified high amylopectin potato notification C/NL/96/10 stated that insufficient risk assessment had been carried out by the notifier. It is a requirement of Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(2) that the notifier carries out a risk assessment to establish the safety of the genetically modified organism.

The dossier submitted to the committee was the same as that originally submitted to the Commission by the Netherlands' competent authority in its capacity as rapporteur Member State plus supplementary information requested subsequently by the competent authorities of the other Member States including the United Kingdom. The scientific committee during its evaluation requested certain additional clarifications from the notifier. The United Kingdom did object to the placing on the market of the product within the 60 day period as laid down in Article 13(2) of Directive 90/220/EEC on the basis that "further information is required to complete the animal feed safety assessment", in particular concerning the amikacin gene. As the Commission is not in possession of the full evaluation report of ACRE, it is not able to comment on the extent of the similarity of the risk assessments applied.

The Commission regrets that at the moment the full opinion is unavailable for reasons of claims of confidentiality by the notifier. In these circumstances, the Commission is examining the legal aspects connected with the publication of the full opinion, in particular in consideration of the provisions for transparency provided by Article 19 of Directive 90/220 and Article 10 of the Decision 97/579/EC setting up the scientific committees in the field of consumer health and food safety(3). As soon as the results of this examination are available, a complementary answer will be transmitted to the Honourable Member.

(1) OJ L 117, 8.5.1990, p. 15.

(2) OJ L 117, 8.5.1990.

(3) OJ L 237, 28.8.1997.