Scientific Opinion on an application (EFSA-GMO-NL-2010-80) for the placing on the market of herbicide-tolerant genetically modified maize NK603 × T25 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

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Article
Panel on Genetically Modified Organisms
Acknowledgements

The Panel wishes to thank the members of the Working Groups on: Molecular Characterisation, Food/Feed Safety, and Environment on GMO applications, for the preparatory work on this scientific opinion, and EFSA staff: Fernando Álvarez, Yann Devos, Antonio Fernandez-Dumont and Ana Gomes, for the support provided to this scientific opinion.

EFSA Journal
EFSA Journal 2015;13(7):4165 [23 pp.].
doi
10.2903/j.efsa.2015.4165
Panel members at the time of adoption
Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József 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
Question Number
EFSA-Q-2010-00880
Adopted
24 June 2015
Published
15 July 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Single events NK603 and T25 were combined to produce the stack two-event maize NK603 × T25. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single maize events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as well as compositional data of maize NK603 × T25, did not give rise to food/feed and environmental safety concerns. The EFSA GMO Panel considers that there is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of maize NK603 × T25. There are no indications of an increased likelihood of establishment and spread of feral maize plants. Considering the scope of application EFSA-GMO-NL-2010-80, potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from maize NK603 × T25 to environmental bacteria does not give rise to any safety concern. The post-market environmental monitoring plan and reporting intervals are in line with the scope. In conclusion, the EFSA GMO Panel considers that the information available for maize NK603 × T25 addresses the scientific comments raised by Member States and that maize NK603 × T25, as described in this application, is as safe as its non-GM comparator and non-GM conventional maize varieties with respect to potential effects on human and animal health and the environment in the context of its scope.

Keywords
GMO, maize (Zea mays), CP4 EPSPS, PAT, herbicide tolerant, stack
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Number of Pages
23