European law

In contrast to recommendations and opinions, directives, regulations and decisions are legally binding for EU Member States. Whereas regulations and decisions are directly applicable in EU Member States, directives only formulate a legal framework, the specific implementation of which into the respective national law is left to the EU Member States. The core of the European Genetic Engineering Law consists of three EU directives:

  1. System Directive (2009/41/EC)
  2. Deliberate Release Directive (2001/18/EC)
  3. Opt-out Directive (EU) 2015/412

The system directive regulates the interaction with genetically modified organisms (GMO) and microorganisms within genetic engineering facilities (e.g. laboratories). The Deliberate Release Directive (“deliberate release” means the (locally and temporarily limited) release of GMO into the environment) covers animals and plants in addition to organisms and microorganisms and regulates the conditions for field trials and certain forms of market placing (the economical usage of GMO). The Opt-out Directive complements the Deliberate Release Directive with an opt-out clause that allows Member States to prohibit the cultivation of genetically modified plants regardless of health and environmental hazards. Member States can therefore apply to the EU Commission for a prohibition on cultivation on their territory during the GMO authorisation procedure as well as withdraw or restrict the authorization to cultivate the GMO after it has already been granted.

Core European directives and regulations for GMOs

Directive 2009/41/EC on the contained use of genetically modified micro-organisms. Online Version

Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms. Online Version

Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory. Online Version

Regulation (EC) 1829/2003 on genetically modified food and feed. Online Version

Regulation (EC) 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. Online Version

Regulation (EC) 1946/2003 on transboundary movements of genetically modified organisms. Online Version

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