Guidance document for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed use by the Scientific Panel on Genetically Modified Organisms (GMO) [1]

No abstract available

ISBN 92-9199-029-9
Publication date: October 2006
Available in English

The Scientific Panel on Genetically Modified Organisms (GMO Panel) adopted its guidance document for the risk assessment of genetically modified microorganisms (GMMs) and their derived products intended for food and feed use on 17 May 2006. The European Food Safety Authority (EFSA) and the GMO Panel have published the guidance on the EFSA web site for public consultation prior to the final adoption of this document.

This document provides guidance for the scientific risk assessment of genetically modified microorganisms (GMMs) and their derived products intended for food and feed use. In particular, it provides detailed guidance to assist in the preparation and presentation of applications to market GMMs and their products for food and/or feed use, according to Regulation (EC) 1829/2003 (EC, 2003a). In addition, this document provides guidance for the risk assessment of food and feed produced using GMMs, irrespective of whether they fall in the scope of Regulation (EC) 1829/2003 or not. Issues related to risk management of GMOs (traceability, labelling) 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. Chapter II describes the overall risk assessment strategy and the regulatory background for the risk assessment of GMOs, GM food and feed at Community level. Chapter III describes the issues to be considered when carrying out a comprehensive risk characterisation. These include general information, information relating to the recipient, the donor(s), the genetic modification and the final GMM, as well as information relating to the GM product. It also includes information on modification of the genetic traits or phenotypic characteristics of the GMM and evaluation of food/feed safety aspects of the GMM and/or derived products. 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 microorganism. A table (Table 1.) summarising the risk assessment requirements for the different GMM groups is also provided. 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 microorganisms and derived product to DG Joint Research Centre.