EFSA Scientific Colloquium N°8: Environmental Risk Assessment of Genetically Modified Plants - Challenges and Approaches, 20 - 21 June 2007, Tabiano, Italy

Tabiano , 20 June 2007

EFSA Scientific Colloquia aim to achieve a better understanding of the fundamental scientific issues in all areas of EFSA’s mission and are organised in a way to provide opportunity for an interactive exchange of expert views. To that end the Scientific Colloquia are sufficiently informal to allow for substantial debates if needed. However, at the same time, they are adequately structured and managed to enable participants to reach conclusions and make recommendations as appropriate. The meeting on Environmental Risk Assessment of Genetically Modified Plants was the eighth in the series of Scientific Colloquia.

On 20 and 21 June, EFSA held a two day Scientific Colloquium in Tabiano, Province of Parma on the Environmental Risk Assessment (ERA) of Genetically Modified (GM) plants. Some 100 scientists and stakeholders from both EU and non-EU countries discussed approaches to environmental risk assessment in the light of current scientific thinking, focusing on issues such as environmental fitness[1], effects on non-target organisms, long-term and large scale environmental effects, broader environmental considerations and the assessment of risk versus environmental benefit.

Participants agreed on the current case-by-case approach to ERA, as outlined in EFSA’s guidance, and that EFSA’s risk assessment work on ERA was at the forefront of developments in this area. Experts at the colloquium argued that more specific guidance may be needed for the assessment of the potential impact on non-target organisms in terms of design and statistical power of testing[2]. Modelling may be a useful tool to predict potential effects that GM plants might have over time and when cultivated on a larger scale in Europe. In addition, post market environmental monitoring will play an important role for determining long-term effects of GM plants and for testing model predictions.

According to Regulation (EC) No 1829/2003 on genetically modified food and feed and Directive 2001/18/EC on deliberate release of genetically modified organisms (GMO) into the environment, a risk assessment of the potential effects that a genetically modified organism might have on human or animal health and the environment, has to be carried out prior putting the genetically modified product on the European market. The EFSA Scientific Panel on Genetically Modified Organisms (GMO Panel) issued a guidance document[1] for the risk assessment of genetically modified plants and derived food and feed, describing an overall risk assessment strategy as well as the issues to be considered when carrying out a comprehensive risk characterization. In this guidance document it was pointed out that risk assessment is an evolving science and that approaches to risk assessment need to be continually challenged and reviewed.The objectives of this colloquium are to consider approaches to environmental risk assessment in the light of current scientific thinking. Issues, such as environmental fitness, impacts on non-target organisms, long-term effects, impacts of large scale production, impacts on life cycles of production systems, broader environmental considerations and risks versus benefits, will be discussed. The meeting is structured and managed to enable the participants to reach conclusions and make recommendations. 

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[1] Ability of a plant to reproduce and invade environments.
[2] The level of confidence that can be attained from the statistical tests in relation to ERA.


Summary report


Main documents

Presentations and Abstracts

Discussion Paper