Monitoring the effects of genetically modified organisms on the environment
Aim
The aim of monitoring the impact of genetically modified organisms (GMOs) on the environment (GMO monitoring) is
- to confirm assumptions regarding the potential harmful effects of a given GMO from the environmental risk assessment (case-specific monitoring) and
- to detect any unexpected harmful effects of a given GMO (general surveillance).
Legal basis
Holders of authorisation to use specified GMOs (placing on the market) are under the obligation to monitor these GMOs. This obligation is based on EU Directive 2001/18/EC on the release of GMOs into the environment, and EU regulation 1829/2003/EC on genetically modified food and feed, both of which are transposed into German law in § 16c of the Genetic Engineering Act (GenTG).
Monitoring plans
Any application for the placing on the market of GMOs and GMO products must include a monitoring plan. This plan provides a detailed description of how the GMOs are to be monitored after authorisation has been granted. The requirements for the monitoring plan are determined in Annex VII to Directive 2001/18/EC and in EU Guidance note 2002/811/EC. Monitoring plans may also be extended by the conditions attached to the official authorisation document.
Monitoring reports
After authorisation has been granted for the placing on the market of a GMO or a GMO product, the consent holder is obligated to monitor this GMO and to deliver reports on the results of the monitoring process to the competent authorities regularly. The content and frequency of the reports are determined in the monitoring plan. Existing monitoring plans may be adjusted or modified where necessary (e.g. on the basis of new knowledge from the monitoring reports)..
Tasks of the BVL
As the national competent authority according to Dir. 2001/18/EC , the BVL coordinates the exchange of information between consent holder, the public and the authorities involved in the approval procedure. The BVL is also involved in developing policies and organisational structures for GMO monitoring. The expertise of other participating national authorities is consulted here.
Other BVL tasks related to monitoring GMOs include the following:
- assessing monitoring plans as part of the approval procedure for the placing on the market of GMOs,
- collecting and filing monitoring reports in a database,
- assessing and evaluating the results from the reports,
- information sharing with other EU countries and the EU Commission, and
- managing the GMO location register and using this as a starting point for monitoring GMOs.
GMO monitoring database
The BVL provides a database, which contains all of the documents relevant to environmental monitoring. The database includes authorisation decisions, monitoring plans and monitoring reports. Using the search function, the search can be aimed at consent holders, authorisation status (import/cultivation), genetic modification, cultivated species or other information.
Click here to access the database.