GUIDANCE DOCUMENT OF THE SCIENTIFIC PANEL ON GENETICALLY MODIFIED ORGANISMS FOR THE RISK ASSESSMENT OF GENETICALLY MODIFIED PLANTS AND DERIVED FOOD AND FEED

The Scientific Panel on Genetically Modified Organisms (GMO Panel) adopted its guidance document for the risk assessment of genetically modified (GM) plants and derived food and feed on 24 September 2004. The European Food Safety Authority (EFSA) and the GMO Panel have consulted stakeholders prior to the final adoption of this document. This document provides guidance for the preparation and presentation of applications submitted within the framework of Regulation (EC) 1829/2003 on GM food and feed, and of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document therefore covers the full risk assessment of GM plants and derived food and feed. Issues related to risk management of GMOs (traceability, labelling, co-existence) are outside the scope of the guidance document. Guidance for the preparation of applications is given throughout the different chapters of the document. The first chapter of the guidance document clarifies the scope of the document and the legal background for the risk assessment of GMOs, GM food and feed at Community level. Chapter II describes the overall risk assessment strategy. Chapter III describes the issues to be considered when carrying out a comprehensive risk characterisation. These include molecular characterisation of the inserts, assessment of modification to the agronomic characteristics of the GM plant and evaluation of food/feed safety aspects of the GM plant and/or derived food and feed. Data on composition, toxicity, allergenicity, nutritional value and environmental impact provide, on a case-by-case basis, the cornerstones of the risk assessment process. The characterisation of risk may give rise to the need for further specific activities including post-market monitoring of the GM food/feed and/or for the environmental monitoring of GM plants. Finally, Chapter IV summaries the overall risk characterisation process. Guidance for the presentation of applications can be found in the Annexes to the guidance document. These include details on the key component parts of the application, on the format of technical dossiers and on the summary of applications. There are also specifications on the submission of samples of GM plant materials to DG Joint Research Centre.