News last update:6 Aug 2012

EFSA and EU work on GMO risk assessment

More than 60 GMO experts from national regulatory risk assessment bodies in the EU met in November 2007 to examine EFSA's risk assessment procedures and its Guidance Documents. The meeting was organised by EFSA, the body that is working closely with EU Member States on GMO risk assessment.

Most experts agreed at the meeting on the general approach on risk assessment methodologies and approaches to GMOs. EFSA is building on the exchange of views to continue to strengthen its risk assessment approach and will take a number of recommendations to the Advisory Forum for further discussion.

Risks of cultivation
One key issue addressed at the meeting was the Environmental Risk Assessment of GM plants intended for cultivation in Europe. Several experts asked EFSA to develop guidance further, particularly concerning field trials, regional specificity and potential effects on non-target organisms. EFSA will pursue its work in this area in co-operation with Member States and in light of a question recently received from the European Commission (DG Environment) on Environmental Risk Assessment.

Use of statistics
The use of statistics in GMO risk assessments, to estimate biological differences between a GM plant and its conventional counterpart, was discussed in detail. EFSA has a working group looking at new statistical methods that could help further advance harmonisation in risk assessment. The majority of Member State experts agreed that statistics had an important role to play in GMO risk assessment but emphasised that biological relevance should drive the dynamics of the risk assessment rather than statistical significance.

Animal feeding trials
On animal feeding trials, the majority of Member State experts was satisfied with present EFSA risk assessment guidance which requires a 90-day feeding trial study whenever evidence indicates significant differences in the GM plant which requires further investigation. However, one Member State expert asked for animal feeding trials to be conducted as a matter of routine. EFSA's GMO Panel has adopted a Report on animal feeding trials which will be published in a peer-reviewed scientific journal over the coming months.

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