WRITTEN QUESTION E-1415/02

by Bart Staes (Verts/ALE) to the Commission

(23 May 2002)

Subject: Safety of maize variety T-25 for consumers

According to reports by the BBC, the maize variety T-25 may be harmful to human and animal health. Despite this, the commercial use of T-25 is permitted by the Commission. Evidently, authorisation was granted on the basis of inaccurate research findings.

1. On what data was the Commission's decision to permit the commercial exploitation of the maize variety T-25 based? Are these data still reliable?

2. Will the Commission have a new study of the safety of the maize variety T-25 made? If not, why not? If so, will it ban the commercial use of T-25 until the findings of the new study are known?

3. Will the Commission investigate what harmful effects the use of the maize variety T-25 has already had on people and animals in Europe? If not, why not?

4. Will the Commission also institute a new investigation into the other three genetically modified maize varieties which it allows to be used for commercial purposes? In the event of irregularities, will it immediately ban their use?

5. What measures will the Commission take to prevent any recurrence of such errors?

Answer given by Mr Byrne on behalf of the Commission

(8 August 2002)

1. The Commission Decision 98/293/EC to grant consent to the placing on the market of T25 for the deliberate release into the environment and for use as animal feed was taken on 22 April 1998(1) in accordance with the provisions of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (GMOs)(2). The Decision was based on the authorisation procedure laid down in Directive 90/220/EEC, which provides for a comprehensive assessment of risks to human health and the environment and evaluation by all the competent authorities of the Member States and the Scientific Committee on Plants (SCP).

The SCP, in particular, was asked to consider whether there was any reason to believe that the placing on the market of the T25 genetically modified maize, with the purpose to be used as any other maize, was likely to cause any adverse effects on human health and the environment. Animal health is considered as part of the environment.

In its opinion, dated 16 February 1998, the SCP concluded that there there is no evidence to indicate that the use of the genetically modified maize as any other maize, is likely to cause adverse effects on human or animal health and the environment. The SCP reviewed its opinion on 20 July 2001 and came to the same conclusion. The SCP has also issued other opinions relating to the safety of T25 maize on 30 November 2000, 20 July 2001 and 19 November 2001.

The notification of the placing on the market of food produced from T25 maize in accordance with Article 5 of the Regulation (EC) No 258/97 of the Parliament and of the council of 27 January 1997, on novel foods and novel food ingredients(3) was submitted to the Commission on 12 January 1998. The notification was based on an opinion given by the competent authority of the United Kingdom, concerning the substantial equivalence of products derived from T25 maize.

In September 2000, the Scientific Committee for Food (SCF) reviewed information provided by the Italian authorities concerning the safety of food produced from T25 maize. The SCF concluded that the information provided by the Italian authorities does not provide detailed scientific grounds for considering that the use of food produced from T25 endangers human health.

2. As detailed in the answer to question 1, the safety of T25 maize has been scientifically evaluated and reviewed on a number of occasions in recent times.

Member States are required, according to Article 4(1) of Directive 90/220/EEC to ensure that all appropriate measures are taken to avoid adverse effects for human health and the environment which might arise from the deliberate release or placing on the market of GMOs.

The relevant scientific committees keep safety assessments under review and take account of any new data.

3. The conclusions of the scientific risk assessments referred to in the answer to question 1 above, give no reason to believe that food produced from T25 maize or the use of T25 in animal feed would have any adverse effects on human or animal health.

4. Directive 90/220/EEC was recently revised and will be replaced by Directive 2001/18/EC of the Parliament and of the Council on 17 October 2002. In accordance with this Directive, consents granted for the placing on the market of GMOs under Directive 90/220/EEC have to be renewed by 17 October 2006. This includes a re-evaluation of the risk assessment.

5. As explained above, the risk assessments of T25 maize and food produced from T25 maize have been carried out in accordance with the procedures for granting approvals under Community legislation.

(1) OJ L 131, 5.5.1998.

(2) OJ L 117, 8.5.1990.

(3) OJ L 43, 14.2.1997.