The experts on EFSA’s GMO Panel put forward some general rules on minimum requirements for the design of field trials aimed at ensuring more accurate statistical evaluation of the safety of GM plants. As with all guidance, the document may well be updated in the future in the light of experience and development of scientific knowledge.

The opinion listed a set of recommendations covering elements such as the number of sites where experiments should be carried out, growing seasons and the geographical spread. In addition, it highlighted some statistical aspects which will benefit from further research, such as the possibility of assessing simultaneously many characteristics of the GM plant. EFSA’s experts also specified that the principles proposed in the opinion may be used, in certain cases, for the evaluation of GMOs other than plants.

EFSA’s risk assessment of genetically modified organisms (GMO) is based on the comparison of the GMO products with their non-GM counterparts. The equivalence between the two must be within the range of variations that would occur between two non-GMO organisms in nature.

The opinion, entitled “Statistical considerations for the safety evaluation of GMOs”, is the product of over two years’ work and capitalises on the experience of EFSA in the evaluation of GMO applications under EU regulations. The initial version of the document was open for public consultation during a 2 month period, from July to September 2008; this allowed the consideration of 98 submissions from various stakeholders.