Scientific Opinion on the assessment of potential impacts of genetically modified plants on non-target organisms

The European Food Safety Authority (EFSA) asked the Panel on Genetically Modified Organisms to establish a self-tasking Working Group with the aim of (1) producing a scientific review of the current guidance of the GMO Panel for Environmental Risk Assessment (ERA), focusing on the potential impacts of GM plants on Non-Target Organisms (NTOs), (2) proposing criteria for NTOs selection, and (3) providing advise on standardized testing methodology. This initiative was undertaken in response to a need and request from a wide range of stakeholders, including the European Commission and Member States. In first instance, the self-tasking Working Group on Non-Target Organisms (EFSA NTO WG) mainly considered impacts of GM plants on invertebrate species, but also took account of ecosystem functions that could be altered. The EFSA NTO WG considered the necessity for clear and objective protection goals, for which assessment and measurement endpoints shall be developed; the need to initiate the scientific risk assessment by setting testable hypotheses; criteria for appropriate selection of test species and ecological functional groups; appropriate laboratory and field studies to collect relevant NTO data; and the use of statistical techniques that should be an integral part of experimental design. The EFSA NTO WG considered the range of approaches and methodologies of ERA of NTOs as described in the current literature and proposed risk assessment approaches based on selection of functional groups and individual species within a tiered approach. The present scientific opinion provides guidance to risk assessors for assessing potential effects of GM plants on NTOs, together with rationale for data requirements in order to complete a comprehensive ERA for NTOs. In this respect, guidance to applicants as outlined in the present opinion has been inserted in the updated Guidance Document of the EFSA GMO Panel for the ERA of GM plants.