• Directives
• Regulations
• Decisions
• Recommendations of the Commission

The European Union’s legally binding means of action are directives, regulations and decisions. The EU institutions can also make recommendations and offer opinions:

EU directives set a legal framework which is effective throughout the EU. They must be transposed into the national law of the individual EU Member States. For example, the Directive 2009/41/EC on contained use of genetically modified micro-organisms and the Directive 2001/18/EC on deliberate release of GMOs into the environment have been transposed into German law by the Genetic Engineering Act (GenTG).

EU regulations are directly applicable in the EU Member States. Implementation into national law is not required. However, it is possible to address national responsibilities in national ordinances. For example, tasks derived from the Regulation (EC) No 1829/2003 on genetically modified food and feed are assigned to the Federal Office of Consumer Protection and Food Safety (BVL) under German law.

With EU decisions, however, only the issues addressed in the decision are binding for the authorities concerned. In this respect, they are similar to the so-called “Verwaltungsakte” (administrative acts) in German law. For example, pursuant to the Directive on the deliberate release of genetically modified organisms, the EU has decided on the organisation of documents which must accompany an application for authorisation of deliberate release of GMOs into the environment or placing them on the market.

EU recommendations and opinions are not legally binding in contrast to acts and regulations. However, they frequently provide a basis for the harmonised interpretation and implementation of European regulations throughout the EU.

Directive 2001/18/EC on the deliberate release of GMOs into the environment in conjunction with the Directive 2009/41/EC on contained use forms the legislative framework for the European law on genetic engineering. The Directive on contained use regulates the handling of genetically modified organisms and micro-organisms in genetic engineering facilities such as laboratories with special equipment. The Directive on the deliberate release of GMOs into the environment covers all kinds of organisms and micro-organisms, also including animals and plants and establishes, among other things, the legal conditions for field trials and certain forms of placing on the market.

In 2015, the Directive 2015/412/EU modified the Directive 2001/18/EC on the deliberate release of GMOs allowing EU member states to restrict or prohibit the cultivation of genetically modified plants on their territory under certain conditions.

Further central regulations which govern the implementation of GMOs include the Regulation 1829/2003/EC on genetically modified food and feed (placing on the market), the Regulation 1830/2003/EC on traceability and labelling and the Regulation 1946/2003/EC on transboundary movements of genetically modified organisms,.

Directives

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Regulations

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Decisions

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Recommendations of the Commission

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