Risk assessment of information on the subcombination Bt11×1507×GA21, related to the application of Syngenta (EFSA-GMO-DE-2011-99) for authorisation of food and feed containing, consisting and produced from genetically modified maize Bt11×59122×MIR604×1507×GA21.

Abstract

The GMO Panel has previously assessed the single events Bt11, 59122, MIR604, 1507 and GA21 as well as different stacked events corresponding to combinations of these events and no safety concerns were identified. In its assessment of the five‐event maize stack Bt11 × 59122 × MIR604 × 1507 × GA21 (application EFSA‐GMO‐DE‐2011‐99), 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 three‐event stack Bt11 × 1507 × GA21. In line with Article 5 of the decision for authorisation of application EFSA‐GMO‐DE‐2011‐99, the European Commission received from Syngenta information on the levels of the newly expressed proteins in subcombination Bt11 × 1507 × GA21 and tasked EFSA to analyse these data and to indicate whether they have an impact on the previously issued opinion on the five‐event stack Bt11 × 59122 × MIR604 × 1507 × GA21 and its subcombinations. Analyses of the levels of the newly expressed proteins Cry1Ab, PAT, Cry1F and mEPSPS showed that there is no indication of an interaction between the events combined in maize Bt11 × 1507 × GA21 that would affect the levels of the newly expressed proteins. Thus, the GMO Panel is of the opinion that the new information for maize Bt11 × 1507 × GA21 does not alter the conclusions of the scientific opinion on application EFSA‐GMO‐DE‐2011‐99.