Scientific Opinion on application (EFSA‐GMO‐CZ‐2008‐62) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 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

摘要

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 × MON 88017 × 59122 for food and feed uses, import and processing. Maize MON 89034 × 1507 × MON 88017 × 5912 was produced by conventional crossing and the F_(1) plant is hemizygous for all newly introduced genes. The maize contains cry1A.105, cry2Ab2, cry1F, pat, cry3Bb1 , CP4 epsps, cry34Ab1 and cry35Ab1 genes conferring resistance against certain lepidopteran and coleopteran target pests and tolerance to glufosinate‐ammonium‐ and glyphosate‐based herbicides. The maize events MON 89034, 1507, MON 88017 and 59122 crossed together to create maize MON 89034 × 1507 × MON 88017 × 59122, behave as independent genetic loci. The F_(2) grain harvested from maize MON 89034 × 1507 × MON 88017 × 59122 is expected to contain a mixture of MON 89034 × 1507 × MON 88017 × 59122 and all 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, MON 88017, and 59122 in maize MON 89034 × 1507 × MON 88017 × 59122 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 × MON 88017 × 59122. 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 × MON 88017 × 59122 were demonstrated to be comparable with those of the single events. Comparative analyses established that maize MON 89034 × 1507 × MON 88017 × 59122 does not differ compositionally, agronomically and phenotypically from its conventional counterpart, and is equivalent to commercial maize varieties, except for the newly introduced traits. The safety assessment identified no concerns regarding potential toxicity and allergenicity of maize MON 89034 × 1507 × MON 88017 × 59122. A feeding study on broiler chickens confirmed the nutritional equivalence of maize MON 89034 × 1507 × MON 88017 × 59122 to its conventional counterpart and commercial maize varieties. Considering the intended uses of maize MON 89034 × 1507 × MON 88017 × 59122, 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 produced by maize MON 89034 × 1507 × MON 88017 × 59122 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 glyphosate‐based herbicides and/or under infestation by 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 maize MON 89034 × 1507 × MON 88017 × 59122, as described in this application, is as safe as its conventional counterpart and commercial maize varieties 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 maize events MON 89034, 1507, MON 88017 and 59122 to produce maize MON 89034 × 1507 × MON 88017 × 59122 does not result in interactions between the events which would affect the safety of maize MON 89034 × 1507 × MON 88017 × 59122 with respect to potential effects on human and animal health and on the environment, in the context of its intended uses. Based on the data provided for maize stack MON 89034 × 1507 × MON 88017 × 59122, the single maize events and for the two parental double stacks 1507 × 59122 and MON 89034 × MON 88017, 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 present in its segregating progeny would raise a safety concern. The EFSA GMO Panel concludes that maize MON 89034 × 1507 × MON 88017 × 59122 is unlikely to have adverse effects on human and animal health and the environment, in the context of its intended uses.