EFSA works with Member States on best approaches to GMO risk assessment

The European Food Safety Authority is working closely with Member States on GMO risk assessment. At a meeting organised by EFSA, more than 60 GMO experts from national regulatory risk assessment[1] bodies from across the European Union discussed best scientific approaches to evaluate the safety of GMOs at national and European level. 

EFSA is pro-actively working to keep at the forefront of risk assessment methodologies and approaches to GMOs and is working with Member States to draw on the best scientific minds in Europe on these issues.

Scientists from the European food safety watchdog, including a number from its GMO Panel, and the national experts nominated by the national food safety agencies met in November 2007 to examine EFSA’s risk assessment procedures and its Guidance Documents. EFSA subjects each individual GMO application to rigorous review carried out according to internationally agreed guidelines.

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.

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.

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.

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[2] . 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.

[1] All EU Member States, Norway and Switzerland and representatives of the European Commission.
[2] The animal feeding trial report says that in cases where molecular, compositional, phenotypic, agronomic and other analyses have demonstrated differences between the GM plant derived food and feed and their conventional counterpart, apart from the inserted trait(s), or if there are any indications or remaining uncertainties for the potential occurrence of unintended effects, animal feeding studies with rodents should be considered