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Release in Germany

The term ‘release’ is used to refer to a field test using GMOs which is to be carried out for a specified period in one or more locations. A GMO could be a plant, an animal, or a microorganism. Under the Genetic Engineering Act, an application for authorisation must be submitted for each intended release. Authorisation will be granted only if, according to scientific knowledge, there is no risk posed to humans or the environment as a result of the release. The Federal Office of Consumer Protection and Food Safety (BVL) has been the competent federal authority for authorising GMO releases in Germany since 1 April 2004. The BVL reaches decisions regarding releases in consultation with the Federal Agency for Nature Conservation, the Federal Institute for Risk Assessment and the Robert Koch Institute. The Julius Kühn Institute - Federal Research Institute for Cultivated Plants (JKI), the “Central Committee on Biological Safety” and the competent authority of the federal state concerned deliver opinions on release projects. The Friedrich Loeffler Institute is also involved when releasing genetically modified vertebrates or genetically modified microorganisms which are to be applied to vertebrates.

The other EU Member States are informed of applications for release and can deliver opinions on these applications.

The authorisation requirement is unaffected by the purpose of the release (e.g. for basic research or the development of new varieties) and each application for release is examined separately. The federal state public authorities are responsible for monitoring the release. Introducing a GMO into the environment without authorisation for release is possible only if the authorisation for EU-wide cultivation of the GMO has been granted as part of a marketing authorisation procedure.

In contrast to GMOs for which EU-wide marketing authorisation has been granted, GMOs which are introduced as part of experimental releases cannot be used as food or feed or further processed for these purposes. However, these GMOs may be introduced into genetic engineering facilities and further testing may be carried out. Genetically modified material which is no longer needed must be inactivated, i.e. it must be made incapable of continued propagation.

Authorisation for release granted to applicants is usually subject to certain conditions. These conditions include, for example, specific precautionary measures for the transportation of GMOs or special measures which ensure that the release is restricted in terms of time and place (isolation distances from neighbouring agricultural land, follow-up controls of the test site after the release has ended).

Frequently Asked Questions (FAQs) on Releases

Additional information can also be found in the explanatory notes to the Frequently Asked Questions on Releases (in German).

Release projects under application

An overview of the releases under application in Germany and Europe can be found here. zu den in Deutschland und Europa beantragten Freisetzungen (in German).

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