Scientific Opinion on GM maize Bt11×MIR162×MIR604×GA21 and its subcombinations

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Article
GMO, maize (Zea mays), Bt11, MIR162, MIR604, GA21, herbicide tolerant and insect resistant, stack
First published in the EFSA Journal
7 December 2015
Adopted
29 October 2015
Type
Opinion of the Scientific Committee/Scientific Panel
Abstract
The EFSA GMO Panel previously assessed the four single events combined to produce a four-event stack maize Bt11 × MIR162 × MIR604 × GA21 and did not identify safety concerns. In this opinion, the EFSA GMO Panel assesses the four-event stack maize and all its subcombinations independently of their origin. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the four-event stack maize did not give rise to safety concerns and there is no reason to expect interactions between the single events impacting on the food and feed safety of the four-event stack maize. Considering the routes of exposure and limited exposure levels, the Panel concludes that this four-event stack maize would not raise safety concerns in the event of accidental release of viable grains into the environment. The EFSA GMO Panel concludes that the four-event stack maize is as safe and as nutritious as its conventional counterpart in the context of its scope. Among the 10 subcombinations, four have been assessed previously and no safety concerns were identified. For the remaining six subcombinations, the EFSA GMO Panel followed a weight-of-evidence approach, and concluded they are expected to be as safe as the four-event stack maize. For some subcombinations that could be produced by conventional crossing through targeted breeding approaches, little or no specific data were submitted, giving rise to uncertainties due to data gaps. To reduce these uncertainties and to confirm assumptions made for the assessment of these subcombinations, the EFSA GMO Panel recommends that the applicant collate relevant information, if these subcombinations were to be created via targeted breeding approaches and commercialised in the future. In this case, this information should focus on expression levels of the newly expressed proteins.
Panel members at the time of adoption
Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Achim Gathmann, Mikolaj Antoni Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, Elsa Ebbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli and Jean-Michel Wal.
Panel on Genetically Modified Organisms
Contact
gmo [at] efsa.europa.eu
doi
10.2903/j.efsa.2015.4297
EFSA Journal 2015;13(12):4297 [34 pp.].
Question Number
On request from
Competent Authority of Germany
Print on demand
Number of Pages
34