Scientific Opinion on application (EFSA-GMO-UK-2007-49) for the placing on the market of the insect resistant and herbicide tolerant genetically modified maize Bt11xGA21 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 Bt11xGA21 for food and feed uses, import and processing. Conventional breeding methods were used in the production of maize Bt11xGA21 from inbred lines of the respective parental events. The structural integrity of the inserts in the single maize events as well as the phenotypes were retained in the stacked maize event. The expression levels of the Cry1Ab, PAT and mEPSPS proteins in maize Bt11xGA21 were demonstrated to be comparable with those of the single maize events. The comparative analysis of phenotypic, agronomic and compositional characteristics of this GM maize indicated equivalence with its non-GM maize counterpart and conventional maize, except for the expression of the target proteins Cry1Ab, PAT and mEPSPS, providing resistance to certain lepidopteran pests and tolerance to glufosinate-ammoniumand glyphosate-based herbicides. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize Bt11xGA21. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to its non-GM maize counterpart and conventional maize. Considering the intended uses of maize Bt11xGA21, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize Bt11xGA21 was required. In case of accidental release of viable maize Bt11xGA21 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 glufosinte-ammoniumand/or glyphosate-based herbicides. The EFSA GMO Panel concludes that maize Bt11xGA21 is as safe as its non-GM maize counterpart with respect to effects on human and animal health and the environment, and is unlikely to have any adverse effect on human and animal health or on the environment in the context of its intended uses.