The scope of this application for the stacked GM maize Bt11xGA21 includes all food and feed uses but no cultivation. As a stacked GM hybrid Bt11xGA21 produces a Bt toxin against lepidoptera such as European Corn Borer and two herbicide tolerances for glyphosate (Roundup) and glufosinate (Liberty, Basta).
Both GM maize events Bt11 and GA21 are currently individually approved as food/feed in the EU, but no approval was granted for cultivation: the GA21 cultivation is still processed by the EFSA GMO Panel, and a decision about Bt11 is still pending at the EU were environmental and/or agricultural ministers did not find a qualified majority for or against the application.
Application status at EU level:
The opinion of the GMO Panel is based on the premise that the 'stacked genes' in a hybrid of two GM events can in general be assessed on the basis of the individual GMOs. In this case it meant for example that no feeding studies were conducted with Bt11xGA21:
As the composition of maize Bt11xGA21 is equivalent to that of non-GM maize varieties and since no indication for interaction between the single events was found, the EFSA GMO Panel is of the opinion that no additional animal safety studies are required.