EU Deliberate Release Directive The Release of GM Plants into the Environment: Authorisation Mandatory

The EU's directive on the deliberate release of GMOs into the environment has been in force since 1992. It was then reworked in 2002, making certain aspects of the directive more restrictive. The directive regulates the authorisation process for releases into the environment of genetically modified organisms (GMOs).

An (en)closed system: The most important steps for developing a GM plant occur in laboratories and in greenhouses. (Photo: Raising genetically modified potato plants) Safety nets: The first field tests with GM plants are partially isolated from the environment. (Photo: Field trial with GM barley in Giessen. The test plot was covered with nets to keep out birds.) Open field trial: After several years, isolation measures for field tests are reduced. (Photo: Field trial with GM potatoes)

Step by step: From the greenhouse to the open field Research and development with plant genetic engineering takes place in specially equipped, safety-controlled laboratories and greenhouses. Stably introducing a new gene into the genome of a plant cell is oftentimes quite laborious. Only after this step is successfully achieved, and enough plants are produced from the transgenic event, that a release into the environment can be considered. Although scientists can already start collecting basic data about the behaviour and characteristics of the new transgenic plant in the laboratory, only in the field can researchers truly see if the GM plant successfully fulfills its intended purpose. Likewise, many aspects of safety research are best understood in open-air and in real soil. To get an idea of how a new GM plant could interact with the environment, one must start off by considering basic biological knowledge along with what is already known from previous experience with such situations. When a GM plant is released for the first time, authorities tend to demand extensive safety precautions. Such precautions can include fences and nets to keep out animals, and minimum separation distances or non-GM plants as buffers to avoid unwanted out-crossing. Authorities also dictate what happens to the GM plants when the trial is over. Naturally, it's impossible to entirely cut a field trial off from the environment. Nonetheless, a step-wise approach minimises risk under controlled conditions in order to collect experience. With more and more experience, safety restrictions are gradually loosened. Trial plots become larger, and the GM plant is tested in more and more regions. Only once it has been shown that the GM plant and its novel trait are harmless to plants, animals, the environment, and soil quality is a GM plant considered worthy of authorisation for commercial cultivation.

Case by case: Every field trail requires authorisation

A separate application must be submitted for each and every field trial. Every approval is contingent on a comprehensive environmental safety assessment. Along with the plant and the novel trait themselves, the assessment also considers the ecosystem in which the field trial is set to take place. Authorisation is granted only when current knowledge of the GM plant cannot point to any environmental risks.

When more experience with a particular GM plant is available, one application can cover field trials at more than one location. Upon certain conditions, further test sites in other EU Member States can be reported without the need to authorise each individually ("differentiated procedure").

National-level approval, EU-wide register

An application for a field trial must be submitted to the compentent national authority for the Member State in which the trial is set to take place. The accompanying documents must substantiate that the field trail does not threaten the environment and the surrounding ecosystem. The national authority decides whether or not to allow the field trial within 90 days of submission.

For every authorised field trial, the national authority provides the European Commission with a summary communicating the most important information in the application (SNIF, summary notification information format). The SNIF document is then made public.

The Public: It is mandatory that the public is informed of all field trials, and that the public is given a voice. Set time frames are given within which individuals or groups can submit a statement.

See also on GMO-Compass:

• The European Regulatory System for GM Plants, Food, and Feed
• EU-Law: The Two Laws Governing Genetically Modified Plants