WRITTEN QUESTION E-2116/01

by Chris Davies (ELDR) to the Commission

(13 July 2001)

Subject: Aventis T25 genetically modified maize

Given the inadequacy of the research aimed at proving the safety of Aventis T25 for humans and the environment, and the suspicious trends present in the tests done on chickens, does the Commission plan to withdraw the authorisation of Aventis 25 against both the Deliberate Release Directive and the Novel Food Regulation?

Answer given by Mr Byrne on behalf of the Commission

(6 November 2001)

The Aventis T25 genetically modified (GM) maize received approval for the placing on the market under Part C of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(1). The authorisation procedure, as for all product notifications, included a comprehensive assessment of risks to human health and the environment and subsequent evaluation by the Scientific Committee on Plants. The Committee concluded that there was no reason to believe that the placing on the market of this product constituted a risk to either human health or the environment.

According to Article 4(1) of the Directive Member States shall ensure that all appropriate measures are taken to avoid adverse effects for human health and the environment. Articles 11(6) and 12(4) of the Directive also refer to further measures that can be taken by Member States in view of new information that becomes available with regard risks to human health and the environment. Furthermore, Article 16 of the Directive allows a Member State to provisionally ban the use or sale of an authorised product on its territory where it has justifiable reasons to consider that the product constitutes a risk to human health and the environment.

Austria invoked the Article 16 clause for the Aventis T25 genetically modified maize in May 2000. The Scientific Committee on Plants concluded, however, that the information submitted by Austria in justification of the ban did not alter the original risk assessment. Recently, the United Kingdom has also invoked the Article 16 clause for this product. The Scientific Committee is currently considering this matter in terms of risk to human health and the environment and the Commission awaits its opinion on the matter.

It should also be noted that this product requires authorisation under Regulation (EC) No 258/97 of the Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients(2), before it can be used as or in food. Use of the maize kernels themselves from the Aventis T25 maize line has not been authorised under the above mentioned Regulation. Under this Regulation, only products derived from Aventis T25, such as flour, starch or oil may be placed on the market, following a notification made to the Commission in January 1998 under Article 5 of the Regulation.

This notification was based on an assessment carried out by the Advisory Committee on Novel Foods and Processes of the United Kingdom, which established that the products concerned were substantially equivalent to products derived from conventional maize varieties and that there would be no risk for human health and the environment.

The Commission does not plan to withdraw authorisation of the foodstuffs derived of the sweet corn line Aventis T25 under Regulation (EC) No 258/97.

(1) OJ L 117, 8.5.1990.

(2) OJ L 43, 14.2.1997.