Assessment of genetically modified soybean GMB151 × DAS‐44406‐6 (application GMFF‐2024‐21774, EFSA‐Q‐2024‐00330)

TL;DR

This paper assesses a genetically modified soybean and concludes it is as safe as non-GM soybean for food, feed, and the environment.

Contribution

The novelty is the safety assessment of a two-event stacked genetically modified soybean variety.

Findings

The two-event stack soybean does not raise food and feed safety or nutritional concerns.

The GMO Panel concludes it is as safe as non-GM soybean for human, animal health, and the environment.

Post-market monitoring of food/feed is not considered necessary.

Abstract

Genetically modified soybean GMB151 × DAS‐44406‐6 was developed by crossing to combine two single events: GMB151 and DAS‐44406‐6. The two‐event stack soybean expresses the Cry14Ab‐1, HPPD‐4, PAT, AAD‐12 and 2mEPSPS proteins to confer herbicide tolerance and resistance to plant parasitic nematodes. 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 soybean does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that two‐event stack soybean, 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/feed is considered necessary. In the case of accidental release of GM two‐event stack soybean material 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 GMB151 × DAS‐44406‐6. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that two‐event stack soybean is as safe as its comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.