Scientific Opinion on an application (Reference EFSA-GMO-NL-2011-100) for the placing on the market of the herbicide-tolerant, increased oleic acid genetically modified soybean MON 87705 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

Abstract

The EFSA GMO Panel previously assessed the two single events combined to produce soybean MON 87705 × MON 89788 and did not identify safety concerns. No new data on the single events affecting the previous conclusions were identified. No differences in composition requiring further assessment were observed between soybean MON 87705 × MON 89788 and its comparator, except for the intended trait i.e. an altered fatty acid profile. Nutritional assessment on soybean MON 87705 × MON 89788 oil and oil-containing food products did not identify concerns on human health and nutrition. There are no concerns regarding the use of feedingstuffs from defatted soybean meal MON 87705 × MON 89788. The EFSA GMO Panel is of the opinion that soybean MON 87705 × MON 89788 is as safe, and at least as nutritious, as its comparator and commercial soybean varieties. 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 87705 × MON 89788. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. 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 87705 × 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 of the application. The EFSA GMO Panel considers that the information available for soybean MON 87705 × MON 89788 addresses the scientific comments raised by Member States. The EFSA GMO Panel concludes, considering the scope of the application, that soybean MON 87705 × MON 89788 is as safe as its comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment. The GMO Panel recommends a post-market monitoring plan, focusing on import data and, if needed, on consumption data for the European population, for the marketed foods and feed.