Guidance on the environmental risk assessment of genetically modified animals


Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2013;11(5):3200 [190 pp.].
Panel Members
Salvatore Arpaia, Nicholas Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, Jozsef Kiss, Gijs Kleter, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks, Christoph Tebbe

EFSA wishes to thank the members of the following Working Groups: Working Group on GM Fish: Anne Kapuscinski, Philip McGinnity, Audun Nerland, Kaare Magne Nielsen, Joe Perry, Fulvio Salati, Joachim Schiemann, Fredrik Sundström, Jeremy Sweet; Working Group on GM Insects: Jeffrey Bale, Romeo Bellini, Michael Bonsall, George Christophides, Patrick du Jardin, Achim Gathmann, Marc Kenis, Jozsef Kiss, Esther Kok, Anna Malacrida, John Mumford, Kaare Magne Nielsen, Steve Sait, Jeremy Sweet; Working Group on GM Mammals and Birds: Phillip Cassey, Flavio Forabosco, Jonathan Jeschke, Jozsef Kiss, David Morton, Kaare Magne Nielsen, Michel Pascal, Joe Perry, Angelika Schnieke, Mike Sharp, Jan Arend Stegeman, Martin Wierup for the preparatory work on this scientific output; and the hearing experts: Ian Cowx, Michael Eckerstorfer, Edmund Peeler, Luke Alphey, Helen Sang and EFSA staff: Yann Devos, Christina Ehlert, Yi Liu, Sylvie Mestdagh, Nancy Podevin, Stefano Rodighiero and Elisabeth Waigmann for the support provided to this scientific output.

Guidance of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
18 aprile 2013
Published in the EFSA Journal
23 maggio 2013
European Food Safety Authority (EFSA), Parma, Italy

This document provides guidance for the environmental risk assessment (ERA) of living genetically modified (GM) animals, namely fish, insects and mammals and birds, to be placed on the European Union (EU) market in accordance with Regulation (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance for assessing potential effects of GM animals on animal and human health and the environment and the rationales for data requirements for a comprehensive ERA. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds. Each specific area of risk is considered in a structured and systematic way following the aforementioned six steps. In addition, this Guidance Document describes several generic cross-cutting considerations (e.g. choice of comparators, use of non-GM surrogates, experimental design and statistics, long-term effects, uncertainty analysis) that need to be accounted for throughout the whole ERA.

Birds, Directive 2001/18/EC, environmental risk assessment (ERA), fish, genetically modified, insects, mammals
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Medical and biological research, Environment policy and protection of the environment
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