Future applications for the marketing of genetically modified organisms (GMOs) in the EU may include food/feed products derived from genetically modified (GM) animals, and the release of GM animals, including insects, into the environment. Efforts towards the development of GM insects to control insect vectors of human diseases and manage agricultural pests have progressed substantially with various GM insect × trait combinations in the development pipeline. As a proactive measure, the scientific GMO Panel of the European Food Safety Authority (EFSA) has developed guidelines on: (1) the risk assessment of food/feed derived from GM animals including animal health and welfare aspects; and (2) the environmental risk assessment (ERA) of living GM animals, including insects, released into the environment for commercial purposes. The latter assists applicants in the preparation and presentation of their applications by describing the elements and data requirements for a structured ERA of GM insects consistent with the current Directive 2001/18/EC. A dedicated Working Group (WG) was involved in the elaboration of the ERA guidelines on GM insects, which underwent a public consultation before their finalisation. Relevant comments received were considered by the WG. The WG also took into account the external scientific report on GM insects commissioned by EFSA (Benedict et al., 2010). This report provided background information by mapping relevant fields of expertise and identified essential elements to be considered when performing an ERA of GM insects. Content and stakeholder involvement for the EFSA guidelines are presented.