Guidance for risk assessment of food and feed from genetically modified plants

This document provides updated guidance for the risk assessment of food and feed containing, consisting or produced from genetically modified (GM) plants, submitted within the framework of Regulation (EC) No 1829/2003 on GM food and feed. The risk assessment strategy for GM plants and derived food and feed proposed seeks to deploy appropriate approaches to compare GM plants and derived food and feed with their respective comparators. The underlying assumption of this comparative approach is that traditionally cultivated crops have gained a history of safe use for consumers and/or domesticated animals. The document provides guidance on how to perform the comparative analysis of the relevant characteristics of the GM plant. The document addresses the details of the different components of the risk assessment: the molecular characterisation, which provides information on the structure and expression of the insert(s) and on the stability of the intended trait(s); the toxicological assessment, which addresses the impact of biologically relevant change(s) in the GM plant and/or derived food and feed resulting from the genetic modification; the assessment of potential allergenicity, of the novel protein(s) as well as of the whole food derived from the GM plant; the nutritional assessment to evaluate whether food and feed derived from a GM plant is not nutritionally disadvantageous to humans and/or animals. In addition every section of the document addresses specifically the requirements for GM plants containing a combination of transformation events, providing guidance on how to establish that the combination is stable and that no interactions occurs between the events that may raise safety concerns. The document does not cover the environmental risk assessment of GM plants which is addressed in a stand-alone environmental risk assessment (ERA) guidance document developed by the EFSA GMO Panel.