Scientific Opinion on an application (EFSA-GMO-NL-2009-70) for the placing on the market of genetically modified drought tolerant maize MON 87460 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
Maize MON 87460 was developed through Agrobacterium-mediated transformation and expresses the cold shock protein B (CspB) from Bacillus subtilis and neomycin phosphotransferase II (NPTII) from Escherichia coli to reduce yield loss under water-limited conditions. Maize MON 87460 contains a single copy of the cspB and nptII expression cassettes. Bioinformatic analysis of the flanking sequences and the open reading frames spanning the junctions created by the transformation did not raise safety issues. Comparative analyses established that, besides the expression of the CspB and NPTII proteins, some differences were observed in the composition of forage and grain produced from maize MON 87460 compared with its conventional counterpart, when grown under well-watered conditions. Given the magnitude of these changes and the characteristics of these endpoints, the EFSA GMO Panel concluded that the observed differences do not raise safety concerns for humans and animals. Under stressful conditions, maize MON 87460 can show enhanced agronomic performance characteristics and some differences in chemical composition in comparison with its conventional counterpart. Given the intended trait, the observed differences were not unexpected, and did indicate no safety concerns. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the CspB and NPTII proteins, or of maize MON 87460. Maize MON 87460 is as nutritious as any other maize and can be used in the same way. In cases of spillage, there are no indications of increased likelihood of the establishment or survival of feral maize plants MON 87460. Risks associated with a theoretically possible horizontal gene transfer from maize MON 87460 to bacteria have been analysed in detail, including different scenarios of integration, and did not raise safety concerns for the intended uses of maize MON 87460. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87460.