EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion on application (EFSAGMO- NL-2007-39) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON89034 x MON88017 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
1 Division of Toxicology and Risk Assessment, National Food Institute, Technical University of Denmark2 National Food Institute, Technical University of Denmark
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 MON88017 for food and feed uses, import and processing. Conventional breeding methods were used in the production of maize MON89034 x MON88017 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, Cry3Bb1 and CP4 EPSPS proteins in maize MON89034 x MON88017 were demonstrated to be comparable with those of the single events. The comparative analysis of compositional, phenotypic and agronomic characteristics of this GM maize indicated equivalence with its conventional counterpart and commercial non-GM maize varieties except for the expression of the target proteins, providing resistance to certain lepidopteran and coleopteran pests and tolerance to glyphosate herbicide. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MON89034 x MON88017. A feeding study on broiler chickens confirmed the nutritional equivalence of this GM maize to its conventional counterpart and commercial non-GM maize varieties. Considering the intended uses of maize MON89034 x MON88017, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of maize MON89034 x MON88017 was required. In case of accidental release of viable maize grain of MON89034 x MON88017 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 glyphosate herbicides. In conclusion, the EFSA GMO Panel considers that the information available for maize MON89034 x MON88017 addresses the scientific comments raised by the Member States and that the maize MON89034 x MON88017 as described in this application is as safe as its conventional counterpart 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 event MON89034 x MON88017 is unlikely to have any adverse effect on human and animal health and the environment, in the context of its intended uses.
Environment; Risk assessment; Regulation (EC) No 1829/2003; GMO; Insect resistant; Herbicide tolerant; Import and processing; Maize MON89034 x MON88017; Food and feed safety; Maize (Zea mays)