Assessment of genetically modified soybean MON 94313 × MON 89788 (application GMFF-2023-17394)

Genetically modified soybean MON 94313 × MON 89788 was developed by conventional crossing to combine two single events: MON 94313 and MON 89788. The two-event stack expresses the DMO, PAT, FT_T.1, TDO and CP4 EPSPS proteins to confer tolerance to dicamba-, glufosinate-, 2,4-D-, mesotrione- and glyphosate-containing herbicides, respectively. The GMO Panel previously assessed the two single soybean events and did not identify safety concerns. No new data on the single soybean events were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the two-event stack does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the two-event stack, as described in this application, is as safe as the comparator and non-GM reference soybean varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of release of processed soybean MON 94313 × MON 89788 or accidental spillage of viable GM soybean seeds into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON 94313 × MON 89788. The GMO Panel concludes that the two-event stack is as safe as its non-GM comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.