EFSA GMO Panel guidance on the evaluation of potential adverse effects of GM plants on non-target organisms

In November 2010, the Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) issued a Scientific Opinion (SO) that delivers guidance on the environmental risk assessment (ERA) of genetically modified (GM) plants. Beside the ERA SO, the EFSA GMO Panel developed a separate SO that provides specific guidance for the evaluation of potential adverse effects of GM plants on non-target organisms (NTOs). This paper describes some elements of the ERA SO and NTO SO pertaining to NTO risk assessment, with a focus on: (1) problem formulation; (2) protection goals and limits of concern; (3) intended and unintended effects; (4) species selection for testing purposes; and (5) stacked transformation events. Some scientific comments from EU Member States and stakeholders received during the development of both documents through public consultations are also presented.