This document contains guidelines prepared by International Life Sciences Institute (ILSI) Europe novel food task force that are intended to assist industry in the preparation of adequate documentation and data when seeking approval for a novel food product. Similarly, these guidelines should provide guidance to government authorities on what may reasonably be required in terms of safety assessment of novel foods. It contains the criteria for the background information on the presentation and use of a novel food or food ingredient, which is necessary to establish the food's safety and help identify the need, if any, for additional studies to facilitate the assessment of toxicological and nutritional safety. It describes the safety assessment of food by equivalence and similarity targeting (SAFEST) and the application of the SAFEST concept to novel foods. Also the nutritional and toxicological information is described that may be required if novel foods or ingredients are not shown to be substantially equivalent to their traditional counterparts.