Scientific Opinion on an application by Syngenta (EFSA-GMO-DE-2011-99) for the placing on the market of maize Bt11 × 59122 × MIR604 × 1507 × GA21 and twenty subcombinations, which have not been authorised previously independently of their origin, for food and feed uses, import and processing under Regulation (EC) No 1829/2003
In this opinion, the EFSA GMO Panel assesses the five-event stack maize and 20 of its subcombinations independently of their origin. The EFSA GMO Panel has previously assessed the five single events that are combined to produce this five-event stack maize Bt11 × 59122 × MIR604 × 1507 × GA21 and did not identify safety concerns. No new data on the single events, leading to a modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the five-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 five-event stack maize. Considering the scope of the application (no cultivation), routes of exposure and limited exposure levels, the Panel concludes that this five-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 five-event stack maize is as safe and as nutritious as its conventional counterpart in the context of its scope. For the 20 subcombinations, the EFSA GMO Panel followed a weight-of-evidence approach, and concluded that they are expected to be as safe as the five-event stack maize. No specific data were submitted for the subcombinations included in the scope of this application that could be produced by conventional crossing through targeted breeding approaches. In order to reduce the consequent uncertainties and to confirm assumptions made for their assessment, the EFSA GMO Panel considers that the applicant should provide relevant information, if these subcombinations were to be created via targeted breeding approaches and imported into the EU in the future. In this case, this information should focus on expression levels of the newly expressed proteins.
A minority opinion expressed by an EFSA GMO Panel member is appended to this opinion.