The EU regulatory framework for GMOs

The current framework

The EU legislation on GMOs originally came into force in 1990 and was amended about 10 years later when the EU regulatory framework for GMOs was complemented with EU Regulations.

The current, comprehensive regulatory framework for GMOs in the EU consists of various Directives and Regulations:

  • Directive 2009/41/EC on the contained use of genetically modified micro-organisms
  • Directive 2001/18/EC on the deliberate release of genetically modified organisms
  • Regulation (EC) No 1829/2003 on genetically modified food and feed
  • Regulation (EC) No 1830/2003 on labelling and traceability of GMOs
  • Regulation (EC) No 1946/2003 on the transboundary movements of GMOs

These Directives and Regulations are complemented by various Decisions and guidelines.

The functioning of the current regulatory framework

Two evaluation reports commissioned by the European Commission show widespread dissatisfaction with the way in which the EU regulatory system for GMOs is implemented.

The procedures for field trials and product approvals of Directive 2001/18 and Regulation 1829/2003 are not functioning as they are designed, because routinely the legal timelines are exceeded . In addition, in several EU member states, the cultivation of one or both of the EU approved GM crops is banned without scientifically sound justification as the European Food Safety Authority (EFSA) has stated on repeated occasions. At the same time, the EU imports every year the equivalent of over 15 million ha of GM crops to feed its livestock sector, resulting in a distortion of competition.

Initiatives for regulatory reform

The European institutions and Member States have taken various initiatives with the aim to
improve the current situation.

Two regulatory proposals currently under discussion are:

  • The ‚Äúcultivation nationalisation‚ÄĚ proposal, which aims to allow Member States to restrict or ban the cultivation of EU approved GMOs.
  • Transformation of EFSA guidance into a Regulation.

These proposals have met with concerns about the Internal Market, WTO rules, the role of the European Food Safety Authority (EFSA), and farming and research in general.