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

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Title: Assessment of genetically modified soybean MON 94637 (application GMFF‐2023‐21116).
Authors: Casacuberta, Josep (AUTHOR), Barro, Francisco (AUTHOR), Braeuning, Albert (AUTHOR), de Maagd, Ruud (AUTHOR), Epstein, Michelle M. (AUTHOR), Frenzel, Thomas (AUTHOR), Gallois, Jean‐Luc (AUTHOR), Koning, Frits (AUTHOR), Messéan, Antoine (AUTHOR), Moreno, F. Javier (AUTHOR), Nogué, Fabien (AUTHOR), Savoini, Giovanni (AUTHOR), Schulman, Alan H. (AUTHOR), Tebbe, Christoph (AUTHOR), Veromann, Eve (AUTHOR), Ardizzone, Michele (AUTHOR), De Sanctis, Giacomo (AUTHOR), Fernandez, Antonio (AUTHOR), Ferrari, Arianna (AUTHOR), Gennaro, Andrea (AUTHOR)
Source: EFSA Journal. Oct2025, Vol. 23 Issue 10, p1-32. 32p.
Subject Terms: *Food safety, *Transgenic organisms, *Biosecurity, Bacillus thuringiensis, Lepidoptera
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. [ABSTRACT FROM AUTHOR]
Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Assessment of genetically modified soybean MON 94637 (application GMFF‐2023‐21116).
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  Data: <searchLink fieldCode="AR" term="%22Casacuberta%2C+Josep%22">Casacuberta, Josep</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Barro%2C+Francisco%22">Barro, Francisco</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Braeuning%2C+Albert%22">Braeuning, Albert</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22de+Maagd%2C+Ruud%22">de Maagd, Ruud</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Epstein%2C+Michelle+M%2E%22">Epstein, Michelle M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Frenzel%2C+Thomas%22">Frenzel, Thomas</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gallois%2C+Jean‐Luc%22">Gallois, Jean‐Luc</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Koning%2C+Frits%22">Koning, Frits</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Messéan%2C+Antoine%22">Messéan, Antoine</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Moreno%2C+F%2E+Javier%22">Moreno, F. Javier</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nogué%2C+Fabien%22">Nogué, Fabien</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Savoini%2C+Giovanni%22">Savoini, Giovanni</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schulman%2C+Alan+H%2E%22">Schulman, Alan H.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tebbe%2C+Christoph%22">Tebbe, Christoph</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Veromann%2C+Eve%22">Veromann, Eve</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ardizzone%2C+Michele%22">Ardizzone, Michele</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22De+Sanctis%2C+Giacomo%22">De Sanctis, Giacomo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fernandez%2C+Antonio%22">Fernandez, Antonio</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ferrari%2C+Arianna%22">Ferrari, Arianna</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gennaro%2C+Andrea%22">Gennaro, Andrea</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Oct2025, Vol. 23 Issue 10, p1-32. 32p.
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  Data: *<searchLink fieldCode="DE" term="%22Food+safety%22">Food safety</searchLink><br />*<searchLink fieldCode="DE" term="%22Transgenic+organisms%22">Transgenic organisms</searchLink><br />*<searchLink fieldCode="DE" term="%22Biosecurity%22">Biosecurity</searchLink><br /><searchLink fieldCode="DE" term="%22Bacillus+thuringiensis%22">Bacillus thuringiensis</searchLink><br /><searchLink fieldCode="DE" term="%22Lepidoptera%22">Lepidoptera</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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. [ABSTRACT FROM AUTHOR]
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  Label:
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  Data: <i>Copyright of EFSA Journal is the property of European Food Safety Authority and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.2903/j.efsa.2025.9581
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        Text: English
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      – SubjectFull: Transgenic organisms
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