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Legal bases

Legal bases

Legal bases

  • © R. Kneschke / fotolia.com

The legal framework for the protection of humans, animals and the environment from the harmful effects of genetic engineering processes and products in the field of genetic engineering are regulated at various levels.

  • The legally binding instruments of action of the European Union (EU) are directives, regulations and decisions. In addition, the organs of the EU can make recommendations and deliver opinions.

    EU directives set an EU-wide legal framework. They must be implemented in national law in the individual EU member states.

    For example, the Directive Directive 2009/41/EG and the Directive 2001/18/EG of the European Parliament and of the Council of March 12, 2001 were implemented by the Genetic Engineering Act (GenTG) and statutory ordinances based on it into German law.

    These two directives form the basic set of rules of European genetic engineering law. The Directive 2009/41/EC regulates the handling of genetically modified organisms within closed systems such as laboratories. The Directive 2001/18/EC regulates the deliberate release into the environment of genetically modified organisms. In addition to microorganisms, the Release Directive also covers organisms such as animals and plants and, among other things, stipulates the legal conditions for field tests and certain forms of placing on the market.

    The Directive (EU) 2015/412 modified the Release Directive to the extent that the member states were given the option of restricting or prohibiting the cultivation of genetically modified plants on their territory under certain conditions.

    Other central regulations that regulate the handling of genetically modified organisms are the regulation on genetically modified food and feed (Regulation (EC) No. 1829/2003), the regulation on the traceability and labelling of genetically modified organisms (Regulation (EC) No. 1830/2003) and the regulation on the transboundary movements of genetically modified organisms (Regulation (EC) No. 1946/2003).

    More detailed information on the regulations within the EU can be found here on the BVL website.

  • In Germany, the Genetic Engineering Act with its ordinances and the EC Genetic Engineering Implementation Act apply.

    Genetic Engineering Act (GenTG)

    The Genetic Engineering Act is the fundamental national law in the area of genetic engineering. Its purpose is both to protect against the dangers of genetic engineering and to enable its research and use. It essentially regulates working with genetically modified organisms, for example in laboratories, and the temporally and spatially limited release of genetically modified organisms.

    Genetic Engineering Safety Ordinance (GenTSV)

    The genetic engineering safety ordinance standardizes safety requirements for genetic engineering work in genetic engineering facilities. The amended GenTSV came into force on March 1, 2021.

    Ordinance on the Central Commission for Biosafety (ZKBSV)

    The ZKBSV regulates the composition and resolution of the ZKBS. 

    More detailed information on the central legal regulations in Germany in the field of genetic engineering can be found here.

  • At the international level, intergovernmental relations are regulated by international treaties and agreements. The Cartagena Protocol is crucial for protecting against adverse effects caused by genetically modified organisms (GMOs). It is a protocol to the Convention on Biological Diversity (CBD).

    Further information on the international agreements can be found here.