German Federal Agency for Nature Conservation (BfN)


Legal Framework for Agro-Genetic Engineering and Associated Procedures

Before genetically manipulated food and feed can be placed on the market, the GMOs involved (which so far have all been plants) are subject to a range of national and EU approval procedures.

Along with other national agencies, BfN participates in various GMO approval processes at national and EU level. When evaluating applications, it focuses on environmental protection and nature conservation issues. The Federal Office of Consumer Protection and Food Safety (BVL) has acted as Germany's leading authority on genetic engineering since 1 April 2004.

Legal Framework

The legal framework to allow genetic engineering in Germany comprises a complex web of EU, federal and state (Länder) legislation. The right to perform experimental release of GMOs is governed by Germany's Genetic Engineering Act (GenTG), which implements the provisions of the EU Deliberate Release Directive (2001/18/EC). This in turn contains a range of provisions that supplement GenTG.

When it comes to approving GMOs for placement on the market, a distinction must be made between a procedure governed by GenTG and one prescribed by Regulation (EC) No. 1829/2003 on Genetically Modified Food and Feed. The GenTC procedure is the older of the two and also transposes Directive 2001/18/EC into national law. The procedure under Regulation 1829/2003 applies to GMOs for use in food and feed production. The ultimate authority in such cases is the European Food Safety Authority in Parma, Italy.

Under the respective approval procedures, GMOs are assessed with regard to specific risks described in genetic engineering law. All genetically modified varieties also require variety approval under Germany's Seeds Marketing Act (Saatgutverkehrsgesetz). Finally, prior to GMOs being planted, a case-specific assessment may be conducted to check for compliance with nature conservation law.

Genetic engineering law also governs the uses for which GMOs may be approved (for example, approval may be given solely for import, storage, processing or cultivation). Rules on global trade of GMOs were agreed in the Cartagena Protocol on Biosafety (CPB), which supplements the Convention on Biological Diversity (CBD).

Deliberate Release and Placing on the Market

The law distinguishes between GMO release and their placement on the market.

Once transgenic crops have been created in the laboratory, research is performed to identify their consumer-focused and in some respects risk-related traits when cultivated in the open environment. This is known as deliberate (experimental) release and is subject to approval. If experimental release leads releasers to conclude that approval for commercial use promises economic success, they may apply for approval to place the GMOs on the market as long as the potential risks associated with their use can be either excluded or controlled.

Approval for Inplacement on the market means that the genetically modified products may be placed on the market and used solely within the provisions laid out in the approval document.

Further information on experimental release and placement on the market

Genetic Engineering in Contained Environments

The Genetic Engineering Act also governs genetic engineering research performed in contained environments (special laboratories and greenhouses). As this usually means that the GMOs do not come into contact with the environment at large, the BfN plays no part in the approval of such research work or of the genetic engineering facilities per se.

Genetic engineering facilities and genetic engineering research are subject to authorisation and approval by the competent Länder authorities. The Central Commission for Biological Safety (CCBS) – an arm of the Federal Office of Consumer Protection and Food Safety (BVL) – plays a role in assessing the safety of genetic engineering research.

Last Change: 23/06/2015