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Genetic engineering – check carefully, approve safely

The release of genetically modified organisms (GMO) for scientific trials needs to be approved by the BVL. If GMO are to be cultivated commercially, the BVL will provide a statement in the Community approval process of the EU. Furthermore, the BVL manages the international information exchange on GMO in the Biosafety Clearing House for Germany. The BVL hosts the secretary of the Central Committee on Biological Safety (ZKBS). The ZKBS advises the Federal Government and the Federal States in safety-relevant questions on genetic engineering

Genetic Engineering

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Since 2004, the Federal Office of Consumer Protection and Food Safety (BVL) is the leading federal authority responsible for the field of genetic engineering in Germany. The BVL fulfils the mandate as national competent authority according to the Genetic Engineering Act (Gentechnikgesetz) and Ordinances of the European Union. The BVL thus assesses notifications for the experimental use of genetically modified organisms (GMO). The BVL is also involved in the approval of GMOs in connection with food and feed. The BVL gives advice to the Federal Government as well as the Federal States (Bundesländer) and their bodies on issues of biological safety in genetic engineering.

Genetic Engineering Act

The national guideline for the BVL in the field of genetic engineering is the Genetic Engineering Act. It implements EU guidelines in national legislation and seeks to protect human and animal health, and the environment, from potential adverse effects of genetic processes and products. Moreover, the genetic engineering law seeks to ensure that food and feed can be produced and placed on the market side-by-side with or without using genetically modified organisms, either conventionally or ecologically. Furthermore, the act builds the legal framework for exploring, developing, using and promoting the scientific, technical and economic benefits of genetic engineering.

Safety Evaluation

The BVL evaluates the safety of genetically modified organisms that are used in contained systems for research and industrial production. Beyond that, the BVL issues authorizations in Germany with the measures required for the safe use of GMOs in temporally and spatially limited experimental releases into the environment. In the EU-wide notification procedures for the commercial use of GMOs (placing on the market), the BVL issues the German position and coordinates the national and international obligations of Germany for enabling co-existence, i.e. the separation of GMOs and non-GMOs. Furthermore, the BVL coordinates environmental monitoring of GMOs by collecting and evaluating the monitoring reports received from notifiers including public institutions and promotes the exchange of information between applicants, governmental agencies and the public.

Approval Procedure for Experimental Release and Placing on the Market

The notification of GMOs for the experimental release into the environment as well as for the commercial placing on the market of GMOs are subject to an assessment and approval process. The notification procedure includes the scientific evaluation of molecular, health, and ecological data by experts in the particular fields, an involvement of the public over several weeks and consultation with further federal and state agencies like the Federal Agency for Nature Conservation, the Robert-Koch-Institute and the Federal Institute for Risk Assessment. In all notification procedures, the BVL asks for an opinion of the Central Commission for Biological Safety (CCBS), which hosts experts in the field of bacteriology, virology, plant breeding, medicine and ecology, as well as industrial and environmental safety. Moreover, the BVL maintains the public registers including the GMO location register as well as the GMO notification register, serving as an information platform on GMOs for the public.

Genetic Engineering in Food

GMO authorization for food is given only for notifications with sufficient scientific data to assess the safety of the GMO and its products. Moreover, GMO food should be evaluated as being as safe as comparable conventional products based on the best currently available scientific data. In addition, the notifier must provide a monitoring plan and an analytical identification method for the GMO. The BVL is the German authority responsible for placing GMOs on the market, comparable with other competent authorities in the European Union. The BVL receives a notification, passes the notification dossier over to the European Food Safety Authority (EFSA), checks the completeness and quality of the data supplied in the dossier, evaluates the risk analysis of the notifier and issues its own statement to the EFSA. Here, the BVL specifies if the notification should be approved from the German point of view, if any further document should be requested from the applicant or if the application should be rejected in the light of potential unacceptable impacts on the protection goals as defined in the Genetic Engineering Act. The BVL is assisted in its activities by the Robert-Koch-Institute, the Federal Biological Research Centre for Agriculture and Forestry, the Federal Agency for Nature Conservation and the Federal Institute for Risk Assessment through expertise and passes its assessments over to the EFSA.

GMO notifications for placing products on the market are processed in an EU-wide approval procedure, in which the EU Commission mediates in case of disagreement between the Members States and if applicable, may introduce its own binding decision. The BVL can implement recommendations for Germany on the national scope of GMO product use and environmental monitoring in line with the European decision. The BVL offers the coordination of GMO monitoring together with activities of other federal authorities and institutions of the Bundesländer in Germany.

Environmental Monitoring

GMO are subject to environmental monitoring after they have been approved in the European Union. The holder of the approval, i.e. usually the company that developed the GMO, is responsible for the organization and implementation of this monitoring. The notifiers are requested to submit their monitoring plans to the BVL for assessment and should report on a yearly basis on the results of monitoring. The BVL has the right to order special safety measures in cooperation with the inspection agencies of the Bundesländer in the event of unforeseen adverse effects. The BVL may also initiate proceedings to temporarily limit or prohibit the placing on the market of a GMO or a GMO product within Germany if a serious risk for human health or the environment is likely to occur.

Traceability and Labelling of GMOs

Complete documentation and labelling is necessary for the traceability of food or feed, from agricultural production to processing and its sale to consumers. In cooperation with the other European agencies, the BVL verifies the labelling proposed by the applicant, coordinates the inspection activities to be implemented by the Federal States, and provides a register on approved GMOs and their methods of detection.

International Activities

The so-called Biosafety Clearing House offers a platform for the exchange of information on GMOs. A register of genes is provided on the Internet platform, which offers information on specific GMOs, e.g. on the molecular characteristics and the country of origin. Furthermore, an official collection of methods for GMO detection is part of a gene register. By accepting the Cartagena Protocol of the United Nations, Germany agreed to contribute to the work of the Biosafety Clearing House. The duty was assigned to the BVL. Furthermore, the BVL is a member of the European Network of GMO-Laboratories, which continues to develop the special GMO detection system in accordance with the current status of science.

At present this English content is the only available in the field of Genetic Engineering. More English content will be provided soon. If you have any questions in the meantime, please let us know by using the contact form.

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