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

EFSA Journal 2011; 9(5): 2150 [37 pp.]. doi:10.2903/j.efsa.2011.2150
  EFSA Panel on Genetically Modified Organisms (GMO) Panel Members 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 Acknowledgment 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. Contact gmo@efsa.europa.eu
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
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.

© European Food Safety Authority, 2011

Summary

The European Food Safety Authority (EFSA) asked the Panel on Genetically Modified Organisms (EFSA GMO Panel) to update its document providing 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 present version of this guidance document, which was adopted on 14 April 2011, was prepared expanding and completing the previous version (EFSA, 2006a) taking into account the experience gained during the evaluation of past applications, and the outcomes of EFSA GMO Panel Working Groups relevant for the risk assessment of GM plants and derived food and feed. 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 (EFSA, 2010a).

The risk assessment of GM plants and derived food and feed involves generating, collecting and assessing information on a GM plant and its derived products in order to determine their impact on human and animal health. The strategy proposed in this document 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 outlines the principles of the risk assessment of GM plants and derived food and feed, providing an overview of the comparative approach and definitions of the different steps and objectives of the risk assessment process. The document provides a detailed overview 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 on human and animal health of biologically relevant change(s) in the GM plant and/or derived food and feed resulting from the genetic modification; the assessment of the allergenic potential of the novel protein(s) as well as of the whole food derived from the GM plant; and the nutritional assessment, which aims to demonstrate that the food and feed derived from a GM plant is not nutritionally disadvantageous to humans and/or animals.

As compared to the previous versions, this document also provides up-to-date guidance on the following issues:

  • the requirements for the risk assessment of GM plants containing stacked events illustrated and addressed in each section, replacing previous EFSA guidance on this topic (EFSA, 2007);
  • the design of the field trials for protein expression analysis;
  • the design of the field trials for compositional, agronomic and phenotypic characteristics ensuring sufficient statistical power (see EFSA, 2010b);
  • the statistical analysis of field trials data, allowing for an objective quantification of observed differences and equivalences between the GM plant and its comparator (see EFSA, 2010b);
  • the selection of appropriate comparator(s) under different possible scenarios (see EFSA, 2011a);
  • reference to internationally agreed protocols for toxicological assessment which may be selectively applied for GMO risk assessment; specific guidance updating and complementing the allergenicity assessment of newly expressed protein(s) and whole GM food and feed (see EFSA, 2010c);
  • animal feeding studies with whole food and/or feed from the GM plant when considered necessary (EFSA, 2008, 2011b).

The present document provides guidance for assessing potential effects of GM plants and derived food and feed on human and animal health, and the rational for data requirements in order to complete a comprehensive risk assessment and to draw conclusions.

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