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Guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects

EFSA Journal 2012;10(1):2501[43 pp.]. doi:10.2903/j.efsa.2012.2501
  EFSA Panel on Genetically Modified Organisms (GMO)   EFSA Panel on Animal Health and Welfare (AHAW) 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 Poeting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel WalAnette Bøtner, Donald Broom, Marcus G. Doherr, Mariano Domingo, Jörg Hartung, Linda Keeling, Frank Koenen, Simon More, David Morton, Pascal Oltenacu, Fulvio Salati, Mo Salman, Moez Sanaa, James M. Sharp, Jan A. Stegeman, Endre Szücs, Hans-H. Thulke, Philippe Vannier, John Webster and Martin Wierup Acknowledgment EFSA wishes to thank the members of the different Working Groups for the preparation of this opinion: GMO Working Group on GM animals: Andrea Crisanti, Ralf Einspanier, Thomas Frenzel, Ian Givens, Esther Kok, Aleksei Krasnov, Ilona Kryspin-Sørensen, Norman Maclean, Heiner Niemann, Helen Sang, Angelika Schnieke, Willem Seinen and the hearing expert Louis-Marie Houdebine. AHAW Working Group on GM animals: Donald Broom; Gijs Kleter; David B. Morton; Pascal Oltenacu; Fulvio Salati; Mike Sharp; John Webster; Martin Wierup and EFSA’s staff members Anna Christodoulidou, Antonio Fernandez Dumont and Nancy Podevin of the GMO Unit and Denise Candiani and Per Have of the AHAW Unit for the support provided to this EFSA scientific output. Possible conflict of interest One member of the GMO Panel did not participate in the discussion on the subject referred to above because of potential conflict of interest identified in accordance with the EFSA policy on declarations of interests. Contact GMO@efsa.europa.eu
AHAW@efsa.europa.eu
Type: Guidance of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2007-069 Adopted: 14 December 2011 Published: 26 January 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

This document provides guidance for the risk assessment of food and feed containing, consisting of or produced from genetically modified (GM) animals, as well as for the health and welfare assessment of these animals, within the framework of Regulation (EC) No 1829/2003 on GM food and feed. The assessment strategy seeks to deploy appropriate approaches to compare GM animals and derived food and feed with their respective comparators. The health status of a food/feed producing animal has traditionally been considered as an important indicator of the safety of derived foods/feed and therefore comparative analysis of the phenotypic characteristics of the GM animal with the traditionally-bred animal, including health and physiological parameters, is considered an important component in the risk assessment. The document addresses 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 possible impact of biologically relevant change(s) in the GM animal and/or derived food and feed, the allergenicity assessment of the novel protein(s), as well as of the whole food derived from the GM animal; and the nutritional assessment to evaluate whether food and feed derived from a GM animal is as nutritious to humans and/or animals as food and feed derived from traditionally-bred animals. This guidance document also addresses the scientific requirements for the assessment of health and welfare of GM animals bred for food and feed use. The assessment is made in terms of the effective functioning of their body systems in a given environment. The document does not cover the environmental risk assessment of GM animals, which will be addressed in stand-alone guidance under development by the EFSA GMO Panel.

© European Food Safety Authority,2012

Summary

The European Commission asked the EFSA Panel on Genetically Modified Organisms (GMO Panel) and the EFSA Panel on Animal Health and Welfare (AHAW Panel) to provide guidance for the risk assessment of food and feed containing, consisting of or produced from genetically modified (GM) animals, within the framework of Regulation (EC) No. 1829/2003 on GM food and feed and guidance on the animal health and welfare of these animals. The document does not cover the environmental risk assessment of GM animals, which will be addressed in a stand-alone environmental risk assessment (ERA) guidance document developed by the EFSA GMO Panel.

The proposed strategy for the health and welfare assessment of the GM animals and the risk assessment of GM animal-derived food and feed seeks to deploy appropriate approaches to compare GM animals and derived food and feed with their respective comparators.

In relation to the food and feed risk assessment, the underlying assumption of this comparative approach is that traditionally-bred animals have a history of consumption as food and feed for the average consumer or animal to which the animal-derived products are fed. These traditionally-bred animals can serve as a baseline for the food and feed safety assessment of GM animals or their products and the welfare of the GM animals. The health status of a food and feed producing animal has traditionally been considered as an important indicator of the safety of derived food and feed and, therefore, the most important component in the risk assessment, addressed in this document, is an extensive comparative analysis of the phenotypic characteristics of the GM animal, including health and physiological parameters. The document also addresses the details of the other components of 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 possible impact of biologically relevant change(s) in the GM animal 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 animal; and the nutritional assessment to evaluate whether food and feed derived from a GM animal is as nutritious to humans and/or animals as traditionally-bred animals.

This guidance document also addresses the scientific requirements for the assessment of health and welfare of GM animals. The assessment is made in terms of the effective functioning of their body systems in a given environment. More precise information may be gained by comparing health and welfare of GM animals with those of their comparators. Where no comparator can be identified, an assessment of health and welfare of the GM animal itself is considered.

Post-Market Monitoring of the GM animals and their derived food and feed is also discussed.

Keywords

GM animals, guidance, applications, Regulation (EC) No 1829/2003, food safety, feed safety, risk assessment, comparative approach, animal health and welfare assessment

Corporate author: EFSA - European Food Safety Authority

Themes: Food technology and food safety

ISBN number: 978-92-9199-468-7

Catalogue number: TM-32-12-516-EN-C

Link to EU-bookshop: Print on demand version

Price: € 3.00

Number of pages: 43

Order status: available