Assessment of genetically modified soybean DBN9004 (application EFSA‐GMO‐BE‐2019‐165)

TL;DR

This paper evaluates the safety of genetically modified soybean DBN9004 and finds it as safe as conventional soybean for food, feed, and the environment.

Contribution

The study confirms the safety of DBN9004 soybean without requiring further post-market monitoring.

Findings

DBN9004 soybean is as safe as conventional soybean for human and animal health.

No environmental safety concerns are identified with DBN9004 soybean.

No post-market monitoring is considered necessary for DBN9004.

Abstract

Genetically modified soybean DBN9004 was developed to confer tolerance to glufosinate‐ammonium‐ and glyphosate‐containing herbicides. These properties were achieved by introducing the cp4 epsps and pat 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 DBN9004 and its conventional counterpart needs further assessment. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the CP4 EPSPS and PAT proteins as expressed in soybean DBN9004 and finds no evidence that the genetic modification would change the overall safety of soybean DBN9004, as food and feed. In the context of this application, the consumption of food and feed from soybean DBN9004 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that soybean DBN9004 is as safe as the conventional counterpart and non‐GM soybean varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of release of soybean DBN9004 material, including viable grains, 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 DBN9004. The GMO Panel concludes that soybean DBN9004 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.