Release of genetically modified plants

A Commission Decision of 22.11.1993 establishes the criteria for simplified procedures concerning the deliberate release into the environment of genetically modified plants (pursuant to Article 6 of Council Directive 90/220/EEC). Given that there is now accumulated knowledge ...

A Commission Decision of 22.11.1993 establishes the criteria for simplified procedures concerning the deliberate release into the environment of genetically modified plants (pursuant to Article 6 of Council Directive 90/220/EEC).

Given that there is now accumulated knowledge and data concerning the necessary prerequisites for safety to human health and the environment for the release of certain types of GMOs (Genetically Modified Organisms), the Commission considers that, under the conditions set out in the Decision, a competent authority may submit to the Commission a request for the application of simplified procedures for the release of such types of GMOs.

The criteria on which the Commission shall decide on an application for simplified procedures include:

- The characteristics of the recipient plant species (taxonomic status and biology) should be well known;

- Information should be available on any interactions of particular relevance for the evaluation of risk, involving the recipient plant species and other organisms in agricultural ecosystems or in the experimental release ecosystem;

- Scientific data should be available on the safety for human health and the environment under the conditions of the experimental release;

- The inserted sequences should be well characterized and integrated into the plant nuclear genome.

With regard to the characteristics of the field release experiments: Whenever necessary, the appropriate practices for the management of risk will be applied during or after the experimental release, to ensure the protection of human health and the environment.

The request must be submitted to the Commission in writing and accompanied by a dossier which includes a description of the proposed simplification procedures, the conditions (if any) under which they are to be applied and information and data on the sufficient experience which has been obtained of releases of the GMOs under consideration.

The Commission shall forward the request and the dossier to the competent authorities of the other Member States, who may notify the Commission in writing (within 45 days) of their intent to join in the request.