Scientific Opinion on application (EFSA-GMO-UK-2007-48) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MIR604 x GA21 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Seeds

This scientific opinion reports on an evaluation of a risk assessment for placing on the market the genetically modified insect resistant and herbicide tolerant maize MIR604 x GA21 for food and feed uses, import and processing. Conventional crossing methods were used in the production of maize MIR604 x GA21 from lines of the respective single maize events. The structure of the inserts in the single maize events, as well as the phenotypes were both retained in the stacked maize events. The expression levels of the mCry3A, PMI and mEPSPS proteins in maize MIR604 x GA21 were demonstrated to be comparable with those of the respective single maize events. The comparative analysis of compositional, phenotypic and agronomic characteristics indicated equivalence of maize MIR604 x GA21 with its conventional counterpart, except for the newly expressed proteins which provided resistance to certain coleopteran target pests and tolerance to glyphosate-based herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MIR604 x GA21. Considering the intended uses of maize MIR604 x GA21, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize MIR604 x GA21 was required. In case of accidental release of viable maize MIR604 x GA21 grains into the environment during transportation and processing, there are no indications of increased likelihood of establishment or survival of feral maize plants, except in the presence of glyphosate-based herbicides. It is highly unlikely that the recombinant DNA will transfer and establish in the genome of bacteria in the environment or human and animal digestive tracts. In conclusion, the EFSA GMO Panel considers that information available for maize MIR604 x GA21 addresses the scientific comments raised by Member States, and that the maize MIR604 x GA21, as assessed in this application, is as safe as its conventional counterpart and other appropriate comparators with respect to potential effects on human and animal health and the environment in the context of its intended uses. The EFSA GMO Panel concludes that maize MIR604 x GA21 is unlikely to have an adverse effect on human and animal health and environment in the context of its intended uses.