Scientific opinion on application EFSA-GMO-NL-2013-120 for authorisation of genetically modified soybean FG72 × A5547-127 for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Bayer CropScience LP and M.S. Technologies LLC.

In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO) assesses the two-event stack soybean FG72 × A5547-127 for food and feed uses, import and processing. The EFSA GMO Panel previously assessed the two single events combined to produce the two-event stack soybean FG72 × A5547-127 and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on soybean FG72 × A5547-127 did not give rise to safety concerns and no reason to expect interactions between the single events impacting on the food and feed safety of the two-event stack soybean was identified. Although the EFSA GMO Panel cannot conclude on forage composition, soybean forage is not expected to be imported in a significant amount for use as feed. Considering the routes of exposure and limited exposure levels, the EFSA GMO Panel concludes that soybean FG72 × A5547-127 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean FG72 × A5547-127. The EFSA GMO Panel concludes that soybean FG72 × A5547-127 is as safe as the non-genetically modified (GM) comparator and non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment.