EN Official Journal of the European Union CE 84/357

(2004/C 84 E/0415)

WRITTEN QUESTION E-0307/04

by Caroline Lucas (Verts/ALE) to the Commission

(6 February 2004)

Subject: Genetically modified crops

In the light of the results of the UK farm-scale evaluations with genetically modified herbicide-tolerant crops, what advice has the Commission given to the competent authorities of Member States which are considering Part C applications to market these crops in Europe under Directive 2001/18/EC?

Does the Commission consider that the applicants will have to provide revised risk assessments according to Article 13(6) of Directive 2001/18/EC, in the light of this new information?

Answer given by Mrs Wallström on behalf of the Commission

(22 March 2004)

The Commission has not given any specific technical advice to the competent authorities of Member States given that consideration of applications, including risk assessments and final decisions, are conducted on a case-by-case basis under Directive 2001/18/EC (1). Similarly, any new information has also to be considered on a case-by-case basis. This approach is applied at all stages of the authorisation procedure.

The farm-scale evaluations conducted in the United Kingdom included cultivation of genetically modified herbicide tolerant maize, spring-sown oilseed rape and sugar beet. Current applications for the placing on the market of genetically modified organisms (GMOs) for cultivation include both herbicide tolerant and other varieties of maize, oilseed rape, sugar beet, fodder beet, potatoes and cotton. In terms of these applications, the Commission has received the assessment reports, from the lead competent authority, for two maize varieties only. The remaining applications are still being appraised by the lead competent authorities and no assessment reports have as yet been forwarded to the Commission.

New information in terms of notifications is, as is correctly pointed out, addressed under Article 13(6) of Directive 2001/18/EC, and where a notifier considers that new information has come to light in terms of risks of the GMO in question to human health or the environment, then there is a requirement to inform the lead competent authority and revise the information and conditions specified in the notification. The lead competent authority may also request further information concerning new information prior to finalising its assessment report.

If a positive assessment report is submitted to the Commission from the lead Member State, then all other Member States and their scientific committees appraise its content with the possibility of raising objections. This would include assessment of any new information, and objections could also be raised if this information was seen as relevant and not included in the initial appraisal. The European Food Safety Authority would also be consulted for opinion where objections remained, including in the context of new information.

In addition: ‘there is no evidence that adverse effects on biodiversity have arisen from the cultivation of a crop which has been modified through modern biotechnology’, as stated in the Form Scale Evaluation (FSE) report.

(1) Directive 2001/18/EC of the Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ L 106, 17.4.2001.