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

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Article
Panel on Genetically Modified Organisms
Acknowledgements

The Panel wishes to thank the members of the EFSA staff Anna Christodoulidou, Zoltán Divéki, Andrea Germini and Claudia Paoletti for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2011; 9(5): 2150
doi
10.2903/j.efsa.2011.2150
Panel members at the time of adoption
Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal
Contact
Type
Guidance of the Scientific Committee/Scientific Panel
On request from
EFSA
Question Number
EFSA-Q-2008-05020
Adopted
14 April 2011
Published
24 May 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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.

Keywords
GMOs, GM plants, GM food, GM feed, guidance, applications, Regulation (EC) No 1829/2003, food safety, feed safety, risk assessment, comparative approach, stacked events, comparator, conventional counterpart