According to Regulation (EC) 1829/2003, EFSA was requested by the European Commission to publish detailed guidance to assist applicants in the preparation and presentation of applications for the authorization of genetically modified (GM) food and/or feed. Within EFSA, this task was assigned to the Scientific Panel on Genetically Modified Organisms (GMO).
A first guidance document for the risk assessment of GM plants was adopted and published following public consultation on 24 September 2004.
A further draft guidance document for the risk assessment of genetically modified microorganisms (GMMs) and derived food/feed was adopted at the Plenary meeting of the GMO Panel on 5 July 2005.
The document provides guidance for the preparation and presentation of applications on GMMs and their derived products intended for food and feed use within the framework of Regulation (EC) 1829/2003. The guidance covers a broad spectrum of GMMs and derived products ranging from pure compounds used in food or feed (food/feed additives, flavourings, etc.) to viable GMMs used as pure cultures (probiotics, starter cultures). In the guidance document all GMMs and derived products intended for food/feed use were divided into three groups with different levels of scrutiny for the risk assessment.