This document describes the elements needed for the safety assessment of foods and feeds derived from genetically modified crops. This document does not address environmental, ethical or socio-economical aspects of the marketing of these foods and feeds, but considers the aspects with relevance to human or animal health. This document provides guidance to notifiers and biosafety assessors as to which extent studies have to be carried out following a case-by-case approach for the evaluation of genetically modified food and feed crops. This guidance document is not a static data package, but should be considered along with newly evolving scientific knowledge and technology. The scientific aspects and the presentation of information in the dossier should fulfil the requirements of the ongoing legislations and recommendations as specified insection 4 of this chapter. This document complements these requirements by providing more detailed guidelines for the safety assessment of foods and feeds derived from genetically modified crops.