WRITTEN QUESTION E-1891/99

by Graham Watson (ELDR) to the Commission

(29 October 1999)

Subject: Field trials of genetically modified crops

When the Commission agreed to field trails of genetically modified crops, did it take into account Article 130r(2) of the Maastricht Treaty establishing the EU?

Community policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Community. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay. Environmental protection requirements must be integrated into the definition and implementation of other Community policies.

In this context, harmonisation measures answering these requirements shall include, where appropriate, a safeguard clause allowing Member States to take provisional measures, for non-economic environmental reasons, subject to a Community inspection procedure.

Will the Commission explain how the decision on GM trials was arrived at?

Answer given by Mrs Wallström on behalf of the Commission

(7 December 1999)

Field trials of genetically modified (GM) crops are authorised under Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(1). Part B of the Directive sets out the authorisation procedure for deliberate releases of genetically modified organisms (GMOs) for research and development purposes.

The Directive is based on the principle that preventive action should be taken in relation to releases which may affect the environment and that due attention should be paid to the protection of human health and the environment when controlling the risks from release of GMOs. The Directive insists that a case by case environmental risk assessment must be carried out prior to any release.

Article 4 of the Directive states that Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from a deliberate release. It also requires each Member State to designate a competent authority responsible for carrying out the requirements of the Directive.

In practical terms, a release for research and development purposes, such as a GM crop field trial, can only happen with the consent of the competent authority for the Member State concerned. In order to gain consent, a notification must be submitted by the company or person concerned. The notification must

include a technical dossier, supplying the information necessary to evaluate foreseeable risks, whether immediate or delayed, and an evaluation of the impact and risks posed by the GMOs to human health or the environment.

The competent authority evaluates this information and, if satisfied that the requirements of the Directive have been met, forwards the information to all Member States for their opinions. The role of the Commission is to facilitate the exchange of information. The release can only proceed with written consent of the competent authority of the Member State.

If information becomes available subsequently to the competent authority which could have significant consequences for the risks posed by the release, the competent authority may require the notifier to modify the conditions of the deliberate release, or suspend or terminate it.

(1) OJ L 117, 8.5.1990.