Scientific Opinion on application (EFSA-GMO-DE-2010-82) for the placing on the market of insect-resistant genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta
This scientific opinion reports an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect-resistant maize MIR162 for food and feed uses, import and processing. Maize MIR162 contains a single insert consisting of the vip3Aa20 and pmi expression cassettes. The Vip3Aa20 protein confers resistance against certain lepidopteran pests and phosphomannose isomerase (PMI) serves as a selection marker. Bioinformatic analyses of the inserted DNA and flanking regions do not raise safety concerns. The levels of Vip3Aa20 and PMI proteins in maize MIR162 have been sufficiently analysed. The stability of the genetic modification has been demonstrated. Comparative analyses established that there are no biologically relevant differences in the compositional, agronomic or phenotypic characteristics of maize MIR162 compared with its conventional counterpart, and its composition falls within the range of non-GM commercial varieties, except for the expression of the Vip3Aa20 and PMI proteins. The safety assessment identified no concerns regarding potential toxicity and allergenicity of Vip3Aa20 and PMI proteins or of maize MIR162. A feeding study on broiler chickens confirmed that grain produced by maize MIR162 is as nutritious as that produced by its conventional counterpart and a non-GM commercial variety. There are no indications of an increased likelihood of establishment and spread of feral maize plants. Considering its intended use as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize MIR162 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of maize MIR162. In conclusion, the EFSA GMO Panel considers that information available for maize MIR162 addresses scientific comments raised by Member States and that maize MIR162, as described in this application, is as safe as its conventional counterpart and non-GM commercial varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.