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Assessment of genetically modified soybean MON 87769 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21253).

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Title: Assessment of genetically modified soybean MON 87769 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21253).
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), Gómez, José Ángel (AUTHOR), Goumperis, Tilemachos (AUTHOR), Lenzi, Paolo (AUTHOR), Camargo, Ana M. (AUTHOR), Piffanelli, Pietro (AUTHOR)
Source: EFSA Journal. Jan2026, Vol. 24 Issue 1, p1-10. 10p.
Subject Terms: *Animal feeds, *Environmental monitoring, *Agricultural industries, Risk assessment, Soybean, Government regulation
Company/Entity: European Food Safety Authority , Bayer CropScience AG , European Union
Abstract: Following the submission of dossier GMFF‐2023‐21253 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the stearidonic acid producing genetically modified soybean MON 87769, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, post‐market monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in soybean MON 87769 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2023‐21253 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87769. [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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Items – Name: Title
  Label: Title
  Group: Ti
  Data: Assessment of genetically modified soybean MON 87769 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21253).
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  Label: Authors
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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="%22Gómez%2C+José+Ángel%22">Gómez, José Ángel</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Goumperis%2C+Tilemachos%22">Goumperis, Tilemachos</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lenzi%2C+Paolo%22">Lenzi, Paolo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Camargo%2C+Ana+M%2E%22">Camargo, Ana M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Piffanelli%2C+Pietro%22">Piffanelli, Pietro</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Jan2026, Vol. 24 Issue 1, p1-10. 10p.
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  Data: *<searchLink fieldCode="DE" term="%22Animal+feeds%22">Animal feeds</searchLink><br />*<searchLink fieldCode="DE" term="%22Environmental+monitoring%22">Environmental monitoring</searchLink><br />*<searchLink fieldCode="DE" term="%22Agricultural+industries%22">Agricultural industries</searchLink><br /><searchLink fieldCode="DE" term="%22Risk+assessment%22">Risk assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Soybean%22">Soybean</searchLink><br /><searchLink fieldCode="DE" term="%22Government+regulation%22">Government regulation</searchLink>
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  Label: Company/Entity
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  Data: <searchLink fieldCode="DE" term="%22European+Food+Safety+Authority%22">European Food Safety Authority</searchLink> <br /><searchLink fieldCode="DE" term="%22Bayer+CropScience+AG%22">Bayer CropScience AG</searchLink> <br /><searchLink fieldCode="DE" term="%22European+Union%22">European Union</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Following the submission of dossier GMFF‐2023‐21253 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the stearidonic acid producing genetically modified soybean MON 87769, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, post‐market monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in soybean MON 87769 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2023‐21253 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87769. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  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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RecordInfo BibRecord:
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      – Type: doi
        Value: 10.2903/j.efsa.2026.9845
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        Text: English
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