Scientific Opinion on application (EFSA-GMO-NL-2007-38) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON89034 x NK603 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

This opinion reports on an evaluation of a risk assessment for placing on the market the genetically modified herbicide tolerant and insect resistant maize MON89034 x NK603 for food and feed uses, import and processing. Conventional breeding methods were used in the production of maize MON89034 x NK603 from inbred lines of the respective parental events. The structural integrity of the inserts in the single events as well as the phenotypes were retained in the hybrid. The expression levels of the Cry1A.105, Cry2Ab2 and CP4 EPSPS proteins in maize MON89034 x NK603 were demonstrated to be comparable with those of the single events. The comparative analysis of phenotypic, agronomic and compositional characteristics of this GM maize indicated equivalence with its non-GM counterpart and conventional maize except for the expression of the target proteins, providing resistance to certain lepidopteran pests and tolerance to glyphosate herbicide. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MON89034 x NK603. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to non-GM counterpart and conventional maize. Considering the intended uses of maize MON89034 x NK603, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize MON89034 x NK603 was required. In case of accidental release of viable maize grain of MON89034 x NK603 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 herbicide. The GMO Panel concludes that maize MON89034 x NK603 is as safe as its non-GM counterpart with respect to effects on human and animal health and the environment.