Guidance document for the risk assessment of genetically modified plants and derived food and feed by the Scientific Panel on Genetically Modified Organisms (GMO) - including draft document updated in 2008


Panel on Genetically Modified Organisms
Guidance of the Scientific Committee/Scientific Panel
Question Number
24 September 2004
28 April 2006
Last Updated
16 June 2009. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy
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ISBN 92-9199-019-1
Printed publication date: May 2006
Available in English

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. In 2006 the Panel enhanced its guidance document by adding a chapter on general surveillance of unanticipated effects. 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.

For citation purposes: Guidance document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed, the EFSA Journal (2006) 99, 1-100.

Draft guidance document updated in 2008

EFSA’s GMO Panel regularly reviews its guidance to take account of scientific developments and of experience gained through the risk assessment process. When doing so the Panel consults interested parties including the European Commission, the Member States and stakeholders as well as the public.

In 2008 the Panel [Asset Included(Id:IONALPARAMS_=fp%3AlinkText%3Dupdated%2520its%2520guidance%2520document%2526amp;_cid_=8888000049933%2526amp;_c_=EFSA_Sc_Document;Type:ITIONALPARAMS_=fp%3AlinkText%3Dupdated%2520its%2520guidance%2520document%2526amp;_cid_=8888000049933%2526amp;_c_=EFSA_Sc_Document)]- based on the report of the related self tasking activity - and on the experimental design of field trials and the statistical analysis of the collected data. The update also incorporated the additional guidance on GM plants containing stacked events , already published by EFSA as separate document. The updated guidance document was also used by the Commission and the Member States as a basis for the preparation of EC Guidelines. EFSA consulted the public on  this document  .

In the longer term the Panel will also update the sections of its guidance on environmental risk assessment, covering among other changes, issues such as assessing potential long-term environmental effects of GMO cultivation, following a mandate from the Commission’s DG Environment. This update will also incorporate the outcome of activities that EFSA has initiated on assessing potential risks to non-target organisms by traits such as insect-resistance in GM plants.