Risk assessment of information on the subcombination Bt11 × MIR162, related to the application of Syngenta (EFSA-GMO-DE-2009-66) for authorisation of food and feed containing, consisting and produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21

GMO, maize (Zea mays), subcombination Bt11 9 MIR162, four-event maize stack Bt11 × MIR162 × MIR604 × GA21, Regulation (EC) No 1829/2003
First published in the EFSA Journal
24. März 2017
2. März 2017


The EFSA Panel on Genetically Modified Organisms (GMO) has previously assessed the single events Bt11, MIR162, MIR604 and GA21 as well as different stacked events corresponding to combinations of these events. These maize events were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. In its assessment of the four-event maize stack Bt11 × MIR162 × MIR604 × GA21, the GMO Panel also assessed all the subcombinations of these events not previously assessed, including some for which little or no experimental data were provided, including the two-stack maize event Bt11 × MIR162 (application EFSA-GMO-DE-2009-66). On 8 November 2016, the European Commission received from Syngenta information on the subcombination Bt11 × MIR162. On 14 December 2016, the European Commission tasked EFSA to analyse these data and to indicate whether they have an impact on the previously issued opinion on the four-event stack Bt11 × MIR162 × MIR604 × GA21 and its subcombinations. The GMO Panel used the appropriate principles described in its guidelines for the risk assessment of genetically modified (GM) plants to analyse the provided data. The levels of the newly expressed proteins Cry1Ab, PAT, Vip3Aa20 and PMI are similar between the two-event stack Bt11 × MIR162 and the corresponding single events Bt11 and MIR162. Based on this analysis, there is no indication of an interaction between the events combined in maize Bt11 × MIR162 that would affect the levels of the newly expressed proteins. Thus, the GMO Panel considers that the new information for maize Bt11 × MIR162 does not alter the conclusions of the scientific opinion on application EFSA-GMO-DE-2009-66.

Panel members at the time of adoption

Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, 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, Jean-Michel Wal.
Panel on Genetically Modified Organisms
gmo [at] efsa.europa.eu
EFSA Journal 2017;15(3):4745
Question Number
On request from
European Commission