Assessment of genetically modified soybean MON 94637 (application GMFF‐2023‐21116)

TL;DR

This paper evaluates the safety of genetically modified soybean MON 94637 and concludes it is as safe as conventional soybean for food, feed, and the environment.

Contribution

The study confirms the safety of MON 94637 soybean, a genetically modified variety, for human and animal consumption and environmental release.

Findings

MON 94637 soybean does not raise food/feed safety or environmental concerns.

No differences in agronomic or compositional characteristics require further assessment.

The Cry1A.2 and Cry1B.2 proteins are not toxic or allergenic.

Abstract

Genetically modified soybean MON 94637 was developed to provide protection against targeted lepidopteran pests. These properties were achieved by introducing the cry1A.2 and cry1B.2 expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between soybean MON 94637 and its conventional counterpart need further assessment. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.2 and Cry1B.2 proteins as expressed in soybean MON 94637 and finds no evidence that the genetic modification would change the overall safety of soybean MON 94637, as food and feed. In the context of this application, the consumption of food and feed from soybean MON 94637 does not represent a nutritional concern in humans and animals, and no post‐market monitoring of food/feed is considered necessary. In the case of release of processed soybean MON 94637 or accidental spillage of viable GM soybean seeds into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan (PMEM) and reporting intervals are in line with the intended uses of soybean MON 94637. The GMO Panel concludes that soybean MON 94637 is as safe as its conventional counterpart and the tested non‐GM soybean varieties with respect to potential effects on human and animal health, and the environment.