Introducting a genetically modified organism (GMO) into the environment.
Authorisation is required whenever a genetically modified plant, animal, or microorganism is intentionally brought into the open environment from a closed system (for example, a laboratory, greenhouse, or production plant) for field testing. Authorisation is only granted if the release does not pose a risk to health or to the environment.
- Each application for field trial is considered individually. An approval is limited to a certain organism at a certain test site.
- After a certain amount of experience with a particular GMO has been collected, the procedure can be simplified. Other test sites can then be added to an existing authorisation.
- Permission is required for releasing GMOs regardless of the purpose, whether it is basic research, cultivar development, agronomic trials, or safety research.
Release without special permission is only possible after the GMO has received authorisation for cultivation. At this point, the GMO is considered “deregulated”.
The same legislation is valid in all EU Member States. Permission is granted by the Member State’s respective authorities.