Requirements for the cultivation of genetically modified plants

Plants may only be cultivated as seed in Germany if they have undergone two approval procedures. They require a marketing authorization that complies with the requirements of the EU Deliberate Release Directive. For this purpose, a marketing authorization under genetic engineering law is usually granted, which is limited to 10 years. In addition, seed authorization under the Seed Trade Act must be obtained from the Federal Plant Variety Office, and the plant must be included as seed in the European Plant Variety Catalogue.
The prerequisite for granting a genetic engineering permit is compliance with the obligations under the Genetic Engineering Act and its regulations. These obligations are largely determined by the Genetic Engineering Plant Production Ordinance (GenTPflEV), which sets out specific, binding regulations for good professional practice in the commercial cultivation of genetically modified plants. First and foremost, the minimum distances specified for each plant species must be observed. For maize, these distances are 150 m from conventionally cultivated areas and 300 m from organically farmed areas.
Even if a marketing authorization and seed approval are in place, further notification and inquiry obligations must be met before sowing the seeds. For example, the cultivation must be registered in the site register with the BVL (Federal Office of Consumer Protection and Food Safety) at least three months before sowing.
In addition, all neighbors who cultivate land within a 300 m radius of the planned (maize) cultivation area must be contacted at this time. These are farmers of agricultural, forestry, or horticultural land that lies entirely or partially within the specified distance (for the respective plant species) from the edge of the cultivation area. The farmers must be informed of the intended cultivation, questioned about their own cultivation methods, and informed of the consequences if they do not respond to the inquiry within one month. As part of this neighborly exchange of information, private agreements often arise between neighboring farmers to deviate from the minimum distances required by the Genetic Engineering Plant Production Ordinance. Care must be taken to ensure that such neighborly agreements are made in writing and must not be to the detriment of third parties. Any agreements reached must be reported to the BVL at least one month before cultivation.
Before sowing for the first time, the nature conservation authority must also be consulted to determine whether there are ecosystems in the vicinity of the site for which special conditions for use to protect specific ecosystems have been included in the marketing authorisation.
In the further process, the Genetic Engineering Plant Production Ordinance stipulates requirements for the cultivation of genetically modified plants regarding the equipment used, as well as the storage and transport of genetically modified seeds or plants. For monitoring purposes, special record-keeping obligations and the obligation to conduct follow-up inspections, i.e., to check the field to determine whether plants of the same species germinate again in subsequent years (volunteering), are stipulated.

This publication can also be found on the website of the law firm Dr. Kauch .