Risk assessment of additional information on maize MIR162

The European Commission requested the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to assess new scientific information on maize MIR162, and to indicate whether the previous conclusions on the safety of maize MIR162 as a single event and as a part of stacked events remain valid. The new information is included in a European patent that reports a decrease in male fertility in some MIR162 inbred lines, pointing to a potential link between such decrease and the Vip3 protein expressed by maize MIR162. The EFSA GMO Panel evaluated the data provided by the patent owner and found scarce support for a causal link between Vip3 and decreased fertility. The general hypothesis of an association between event MIR162 and altered fertility could not be confirmed. The EFSA GMO Panel conducted the safety assessment based on the conservative assumption that such an association exists. The EFSA GMO Panel concluded that a decrease in male fertility would have no impact on the previous conclusions on maize MIR162 and stacked events containing MIR162.