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

Genetically modified soybean DBN9004 was developed to confer tolerance to glufosinate-ammonium- and glyphosate-containing herbicides. These properties were achieved by introducing the <i>cp4 epsps</i> and <i>pat</i> 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.

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Publication Details

Journal
EFSA Journal
Published
2025-07-01
DOI
https://doi.org/10.2903/j.efsa.2025.9503
Primary Topic
Genetically Modified Organisms Research
Type
article
Field-Weighted Citation Impact
0.00

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article

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

Arianna Ferrari, Giacomo De Sanctis, José Ángel Gómez Ruiz, Aleksandra Lewandowska et al.
EFSA Journal
Genetically Modified Organisms Research
article

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

Arianna Ferrari, Giacomo De Sanctis, José Ángel Gómez Ruiz, Aleksandra Lewandowska, Jean‐Luc Gallois, Tommaso Raffaello, Ruud A. de Maagd, Francisco Barro, Alan H. Schulman, Antoine Messéan, Fabien Nogué, Tilemachos Goumperis, Frits Koning, Josep Casacuberta, Dafni Maria Kagkli, Pietro Piffanelli, Eve Veromann, Ana M. Camargo, Albert Braeuning, F. Javier Moreno, M. Epstein, Giovanni Savoini, Thomas Frenzel, Antonio Fernández Dumont, Michele Ardizzone, Christoph Tebbe, Elena Sánchez‐Brunete
article en

Abstract

Genetically modified soybean DBN9004 was developed to confer tolerance to glufosinate-ammonium- and glyphosate-containing herbicides. These properties were achieved by introducing the <i>cp4 epsps</i> and <i>pat</i> 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.

EFSA JournalVol. 23(7)
European Food Safety Authority (IT), University of Helsinki (FI), Estonian University of Life Sciences (EE), Leiden University Medical Center (NL), Federal Institute for Risk Assessment (DE), Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (FR), Institute for Biodiversity (DE), Département agronomie et sciences de l'environnement pour les agroécosystèmes (FR), Institut Jean-Pierre Bourgin (FR), Génétique et amélioration des fruits et légumes (FR), Instituto de Agricultura Sostenible (ES), Center for Research in Agricultural Genomics (ES), Saxon State Ministry for Science and the Arts (DE), University of Milano-Bicocca (IT), Universidad de Sevilla (ES), Wageningen University & Research (NL)
European Food Safety Authority
Openalex Percentile: Top 88%
Genetically Modified Organisms Research
DOIOpen Access PDFOpenAlex
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