The documents to be submitted with applications for authorisation for release in line with § 15 ( 1) of the Genetic Engineering Act are identified in § 5 of the Genetic Engineering Procedural Regulation (GenTVfV). These include:

• proof of expertise of responsible persons,
• extensive information on the GMOs to be released,
• information on potential safety-related consequences, and
• information about monitoring and terminating the release, along with emergency plans.

The information required is listed in Annex III to Directive 2001/18/EC. Annex III B specifies the requirements for the release of genetically modified higher plants. Obligatory information to be included in applications for the release of all GMOs excluding high plants is indicated in Annex III. These requirements apply to the application documents to the extent that the information is relevant to the GMO to be released.