Scientific Opinion updating the risk assessment conclusions and risk management recommendations on the genetically modified insect resistant maize Bt11


Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2012;10(12):3018 [104 pp.].
Panel members at the time of adoption
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.

The Panel wishes to thank the members of the three Standing Working Groups on Molecular Characterisation, Food/Feed and Environment of GMO applications for the preparatory work on this scientific output, and Yann Devos, Zoltan Diveki, Andrea Gennaro, Yi Liu, Sylvie Mestdagh and Stefano Rodighiero for the support provided to the development of this EFSA scientific output.

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

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) compiled its previous risk assessment conclusions and risk management recommendations on the genetically modified insect resistant maize Bt11, and considered their validity in the light of new relevant scientific publications published from 2005 onwards. Following a search of the scientific literature published between 2005 and October 2012, the EFSA GMO Panel identified 287 peer-reviewed publications containing evidence specific to the risk assessment and/or management of maize Bt11, of which 270 publications were previously discussed and cited in relevant GM maize-related applications and/or the numerous EFSA GMO Panel scientific outputs. From the remaining 17 publications, three were relevant for the food and feed safety assessment, and 14 for the environmental risk assessment and/or risk management of maize Bt11. None of these publications reported new information that would invalidate the previous conclusions on the safety of maize Bt11 made by the EFSA GMO Panel. Therefore, the EFSA GMO Panel considers that its previous risk assessment conclusions on maize Bt11, as well as its previous recommendations on risk mitigation measures and monitoring, remain valid and applicable.

GMO, maize (Zea mays), Bt11, insect resistance, Cry1Ab, risk assessment, food and feed safety, environment, food and feed uses, import and processing, cultivation
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