Scientific Opinion on an application (EFSA-GMO-NL-2009-65) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON 89034 × 1507 × NK603 and all sub-combinations of the individual events as present in its segregating progeny, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Dow AgroSciences and Monsanto

This scientific opinion is an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect resistant and herbicide tolerant maize MON 89034 × 1507 × NK603 for food and feed uses, import and processing. Maize MON 89034 × 1507 × NK603 was produced by conventional crossing methods and the F1 plant is hemizygous for all newly introduced traits. The maize contains cry1A.105, cry2Ab2, cry1F, pat, CP4 epsps and CP4 epsps l214p genes conferring resistance against certain lepidopteran target pests and tolerance to glufosinate-ammonium- and glyphosate-based herbicides. The maize events MON 89034, 1507 and NK603, crossed together to create maize MON 89034 × 1507 × NK603, behave as independent genetic loci. The F2 grain harvested from maize MON 89034 × 1507 × NK603 and assessed for safety is expected to contain a mixture of MON 89034 × 1507 × NK603 and all sub-combinations of the individual events which will be imported and processed for food and feed uses. The EFSA GMO Panel has evaluated the risk assessment with respect to safety concerns which might arise through any potential combination of the following events MON 89034, 1507 and NK603 in maize MON 89034 × 1507 × NK603 and in its segregating progeny. Molecular analyses indicated that the structure of the inserts in the single events was retained in maize MON 89034 × 1507 × NK603. Updated bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert-plant DNA junctions did not raise any safety concern. Levels of the newly expressed proteins in maize MON 89034 × 1507 × NK603 were demonstrated to be comparable with those of the single events. Comparative analyses established that maize MON 89034 × 1507 × NK603 is compositionally, phenotypically and agronomically comparable to its conventional counterpart and equivalent to commercial maize varieties, except for the newly expressed proteins. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MON 89034 × 1507 × NK603. Considering the intended uses of maize MON 89034 × 1507 × NK603, which excludes cultivation within the European Union, no scientific assessment of potential environmental effects associated with cultivation of this maize was required. In case of accidental release of viable grains from maize MON 89034 × 1507 × NK603 into the environment during transportation and processing, there are no indications of an increased likelihood of establishment or survival of feral maize plants, except in the presence of glufosinate-ammonium- and/or glyphosatebased herbicides and/or under infestation of target pests. It is highly unlikely that the recombinant DNA will be transferred and establish itself 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 MON 89034 × 1507 × NK603 addresses the scientific comments raised by the Member States and concludes that the maize MON 89034 × 1507 × NK603, 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 addition, the EFSA GMO Panel is of the opinion that crossing of single maize events MON 89034, 1507 and NK603 to produce maize MON 89034 × 1507 × NK603 does not result in interactions between the events which would affect the safety of maize MON 89034 × 1507 × NK603 with respect to potential effects on human and animal health and on the environment, in the context of its intended uses. Based on data provided for maize stack MON 89034 × 1507 × NK603, the single maize events (MON 89034, 1507 and NK603), and for the two double stacks 1507 × NK603 and MON 89034 × NK603, the EFSA GMO Panel is of the opinion that there is no biological reason to expect that any of the other sub-combinations of the individual events as present in its segregating progeny would raise a safety concern. The EFSA GMO Panel concludes that maize MON 89034 × 1507 × NK603 is unlikely to have adverse effects on human and animal health and the environment, in the context of its intended uses.