Scientific Opinion on an application from Pioneer Hi-Bred International and Dow AgroSciences LLC (EFSA-GMO-NL-2005-23) for placing on the market of genetically modified maize 59122 for food and feed uses, import, processing and cultivation under Regulation (EC) No 1829/2003

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Article
Panel on Genetically Modified Organisms
Acknowledgements

The Panel wishes to thank the members of the Standing Working Groups on Molecular Characterisation, Food and Feed Safety Assessment, and Environmental Risk Assessment of GMO applications, the external experts Jeremy Sweet and Jean-Michel Wal and the EFSA staff member Yann Devos, for the preparatory work on this Scientific Opinion, and the EFSA staff members Yann Devos, Christina Ehlert, Anders Falk, Antonio Fernandez Dumont, Andrea Germini, Ana Gomes and Yi Liu, for the support provided to the development of this EFSA scientific output.

EFSA Journal
EFSA Journal 2013;11(3):3135 [104 pp.].
doi
10.2903/j.efsa.2013.3135
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 and Christoph Tebbe.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands for an application (EFSA-GMO-NL-2005-23) submitted by Pioneer Hi-Bred International and Dow AgroSciences LLC
Question Number
EFSA-Q-2005-250
Adopted
6 March 2013
Published
26 March 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note

This Scientific Opinion, published on 26 March 2013, has been supplemented with a Statement published on 21 November 2013.

Abstract

This Scientific Opinion reports on a risk assessment on an application for placing on the market of genetically modified maize 59122 for import and processing for food and feed uses and cultivation. The EFSA GMO Panel considers that maize 59122 is unlikely to have any adverse effect on the environment, except for the possible evolution of resistance to the Cry34Ab1/Cry35Ab1 proteins in coleopteran target pests. The Panel recommends the implementation of appropriate and diversified insect resistance management strategies and case-specific monitoring to delay and monitor the possible evolution of resistance to Cry34Ab1/Cry35Ab1 in coleopteran target pests, respectively. In addition, the Panel recommends revision of the applicants’ insect resistance management plan and the proposed post-market environmental monitoring plan. Although maize 59122 is tolerant to glufosinate-ammonium-based herbicides, the Panel did not assess the potential adverse effects associated with the use of such herbicides on maize 59122, as maize 59122 will not be marketed in the European Union as a herbicide-tolerant crop. This Scientific Opinion updates the previous Panel safety evaluation of the food and feed uses, and import and processing of maize 59122 and derived products. The Panel concludes that the information available for maize 59122 addresses the scientific comments raised by Member States and that maize 59122, as described in this application, is as safe as its conventional counterpart and commercial maize varieties with respect to potential adverse effects on human and animal health. If subjected to appropriate management measures, the cultivation of maize 59122 is unlikely to raise safety concerns for the environment.

Keywords
GMO, maize (Zea mays), 59122, cry34Ab1, cry35Ab1, risk assessment, food and feed safety, environment, cultivation.
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Number of Pages
104