Policy Making

Potential long term effects of the deliberate release on GMOs into the environment

Article 4(3) of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs) requires Member States and, where appropriate, the Commission to ensure that potential adverse effects on human health and the environment are accurately assessed on a case-by-case basis as part of each notification for the deliberate release of a GMO into the environment. Importantly, this requirement applies both to applications for research purposes and for placing on the market.

A general principle for environmental risk assessment is that 'an analysis of the cumulative long-term effects relevant to the release and the placing on the market is to be carried out'. Cumulative long-term effects refers to the accumulated effects of authorised release on human health and the environment, including inter alia flora and fauna, soil fertility, degradation of soil organic material, the feed/food chain, biological diversity and animal health, and to resistance problems in relation to antibiotics.

More information can be found here: "Reports and Studies"