Defining environmental risk assessment criteria for GM insects to be placed on the EU market
Abstract: Global efforts towards the development of genetically modified (GM) arthropods haveprogressed to a stage where some might possibly be placed on the EU market within the nextdecade. To facilitate the risk assessment of particular GM arthropod applications the specific riskissues associated with these applications need to be addressed. To inform the development ofadequate and comprehensive guidelines by EFSA, a study was carried out to provide backgroundinformation on the possibilities and state of development of GM arthropods, the potential adverseeffects associated with applications relevant for release in the EU and the methods to investigatethese effects.The ERA of GM arthropods should consider various issues regarding the geneticmodification and the method used for modification, as well as the purpose of the GM arthropodapplication. In that respect the specifics of potential applications, e.g. control of a target speciesby population suppression or applications designed for population replacements need to beacknowledged during assessment. Potential risks also depend on the respective species, which ismodified and the receiving environment for releases. Issues concerning gene flow and itsconsequences, effects on target and non-target organisms, management practices and humanhealth need to be considered in a specific way. It is recommended to follow a case-by-caseapproach for the ERA of GM arthropods to identify the specific risk issues. Key parameters forthe assessment of risk issues were proposed and described and available methods for assessmentwere evaluated.