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.

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

“…The updated bioinformatic analyses confirm the previous conclusions on the likelihood of occurrence of horizontal gene transfer for soybean MON 89788 event (EFSA GMO Panel, 2015b). It was concluded that the unlikely, but theoretically possible, horizontal transfer of recombinant genes from soybean MON 89788 to bacteria did not raise any environmental safety concern.…”

Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

“…Effects of temperature and pH on CP4 EPSPS and Cry3Bb1 proteins have been previously evaluated by the EFSA GMO Panel (EFSA GMO Panel, 2009, 2015b, 2015c, 2017a. No new studies were provided in the context of this application.…”

Statistical strategies for multiple testing in the safety evaluation of a genetically modified crop

“…The EFSA guidance seems to adopt this approach. Nonetheless, the traditional industry practice and recent regulatory opinions indicate that the safety of a GM crop is evaluated at each specific endpoint (literature listed in Table 1; EFSA 2015 a , b , c , 2016). This supports grouping the two comparisons at a given endpoint into a family, i.e.…”