European Union legal framework on GMO’s

The European Union has established a legal framework to ensure that the development of modern biotechnology, and more specifically of GMOs, takes place in safe conditions.

The legal framework aims to:

  • Protect human and animal health and the environment by introducing a safety assessment of the highest possible standards at EU level before any GMO is placed on the market.
  • Put in place harmonised procedures for risk assessment and authorisation of GMOs that are efficient, time-limited and transparent.
  • Ensure clear labelling of GMOs placed on the market in order to enable consumers as well as professionals (e.g. farmers, and food feed chain operators) to make an informed choice.
  • Ensure the traceability of GMOs placed on the market

The building blocks of the GMO legislation are:

  • Directive 2001/18/EC on the deliberate release of GMOs into the environment
  • Regulation (EC) 1829/2003 on genetically modified food and feed
  • Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
  • Regulation (EC) 1830/2003 concerning the traceabilityand labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms
  • Directive 2009/41/EC on contained use of genetically modified micro-organisms. Regulation (EC) 1946/2003 on transboundary movements of GMOs

These main pieces of legislation are supplemented by a number of implementing rules or by recommendations and guidelines on more specific aspects.


Reports on the implementation of the GMO legislation can be found here.


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