Scientific Opinion supplementing the conclusions of the environmental risk assessment and risk management recommendations for the cultivation of the genetically modified insect resistant maize Bt11 and MON 810


Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2012;10(12):3016 [32 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 M. Nielsen, Jaroslava Ovesná, Joe Perry, Nils Rostoks, Christoph Tebbe.

The Panel wishes to thank the members of the Standing ‘Environment’ Working Group on GMO applications: Salvatore Arpaia, Detlef Bartsch, Nicholas Birch, Achim Gathmann, Jozsef Kiss, Antoine Messéan, Joe Perry, Jeremy Sweet, Christoph Tebbe for the preparatory work on this scientific opinion and EFSA staff: Yann Devos, Andrea Gennaro and Sylvie Mestdagh for the support provided to this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
6 December 2012
Published in the EFSA Journal
11 December 2012
European Food Safety Authority (EFSA), Parma, Italy

The EFSA GMO Panel was asked by the European Commission to apply its mathematical model to simulate and assess potential adverse effects resulting from the exposure of non-target Lepidoptera to maize Bt11 or MON 810 pollen under hypothetical agricultural conditions, and to provide information on the factors affecting the insect resistance management plan, additional to that in its 2011 Statement supplementing the evaluation of the environmental risk assessment and risk management recommendations on insect resistant genetically modified maize Bt11 for cultivation. Here, risk managers are provided with additional evidence and further clarifications to those previous conclusions and risk management recommendations. This Scientific Opinion provides background scientific information to inform the decision-making process; the EFSA GMO Panel reiterates that risk managers should choose risk mitigation and management measures that are proportionate to the level of identified risk according to the protection goals pertaining to their regions.

Bt11, Cry1Ab, environmental safety, GMO, insect resistance, maize (Zea mays), mathematical modelling, MON 810, non-target Lepidoptera
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