Scientific Opinion on application (EFSA-GMO-DE-2011-95) for the placing on the market of genetically modified maize 5307 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG
Maize 5307 was developed by Agrobacterium tumefaciens-mediated transformation to express two proteins: eCry3.1Ab, conferring resistance to certain coleopteran pests, and phosphomannose isomerase (PMI), used as selection marker. The molecular characterisation showed relevant similarities between the amino acid sequence of PMI and a known allergen, and between the amino acid sequence of eCry3.1Ab and a potential toxin. Some agronomic and phenotypic differences between maize 5307 and its conventional counterpart were observed (higher ‘heat units to 50 % pollen shed’, grain moisture, plant height, grain yield); however, the EFSA GMO Panel considered that these do not give rise to food/feed or environmental safety concerns. No differences in the compositional data requiring further safety assessment were identified. There were no concerns regarding the potential toxicity and allergenicity of the PMI protein. The EFSA GMO Panel could not conclude on the safety of the eCry3.1Ab protein due to the inadequate 28-day toxicity study provided. The outcome of a broiler feeding study with maize 5307 was not assessed by the EFSA GMO Panel, due to study weaknesses. There are no indications of an increased likelihood of the establishment and spread of feral maize plants. Interactions with the biotic and abiotic environment were not considered to be a relevant issue. Risks associated with the unlikely but theoretically possible horizontal gene transfer of recombinant genes from maize 5307 to bacteria were not identified. The post-market environmental monitoring plan and reporting intervals are in line with the scope of the application. In conclusion, in the absence of an appropriate assessment of eCry3.1Ab, the EFSA GMO Panel is not in a position to complete its food/feed risk assessment of maize 5307. However, the EFSA GMO Panel concludes that the maize 5307 is unlikely to have any adverse effect on the environment in the context of its scope.