Scientific Opinion on application (EFSA‐GMO‐NL‐2012‐108) for the placing on the market of the herbicide‐tolerant genetically modified soybean MON 87708 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

摘要

Single events MON 87708 and MON 89788 were combined to produce the stack two‐event soybean MON 87708 × MON 89788. The EFSA GMO Panel previously assessed the two single events and did not identify safety concerns in the context of their scope. No new data on single soybean events leading to a modification of the original conclusions on their safety were identified. Agronomic and phenotypic characteristics, as well as compositional data of soybean MON 87708 × MON 89788, did not give rise to food/feed and environmental safety concerns. The EFSA GMO Panel considers that there is no reason to expect interactions between the single events that could impact on the food and feed safety and the nutritional properties of soybean MON 87708 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering the scope of application EFSA‐GMO‐NL‐2012‐108, potential interactions with the biotic and abiotic environment were not considered to be a relevant issue. The unlikely but theoretically possible transfer of the recombinant genes from soybean MON 87708 × MON 89788 to environmental bacteria does not give rise to any safety concern. The post‐market environmental monitoring plan and reporting intervals are in line with the scope. In conclusion, the EFSA GMO Panel considers that the information available for soybean MON 87708 × MON 89788 addresses the scientific comments raised by Member States and that the soybean MON 87708 × MON 89788, as described in this application, is as safe as its non‐GM comparator and non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of its scope.