Scientific Opinion on application (Reference EFSA-GMO-UK-2008-56) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize Bt11 x 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 Bt11 x MIR604 x GA21 for food and feed uses, import and processing. Conventional crossing methods were used in the production of maize Bt11 x 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 Cry1Ab, PAT, mCry3A, PMI and mEPSPS proteins in maize Bt11 x 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 Bt11 x MIR604 x GA21 with its conventional counterpart except for the newly expressed proteins which provided resistance to certain lepidopteran and coleopteran target pests and tolerance to glufosinate-ammonium- and/or glyphosate-based herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize Bt11 x MIR604 x GA21. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to its conventional counterpart and a commercial non-GM maize variety. Considering the intended uses of maize Bt11 x MIR604 x GA21, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize Bt11 x MIR604 x GA21 was required. In case of accidental release of viable maize Bt11 x 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 the glufosinate-ammonium- and/or 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 the information available for maize Bt11 x MIR604 x GA21 addresses the scientific comments raised by Member States and that the maize Bt11 x 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 Bt11 x MIR604 x GA21 is unlikely to have an adverse effect on human and animal health and the environment, in the context of its intended uses.