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Assessment of genetically modified cotton GHB614 × LLCotton25 for renewal authorisation under regulation (EC) No 1829/2003 (dossier GMFF‐2024‐21890).

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Title: Assessment of genetically modified cotton GHB614 × LLCotton25 for renewal authorisation under regulation (EC) No 1829/2003 (dossier GMFF‐2024‐21890).
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), Camargo, Ana M. (AUTHOR), Lenzi, Paolo (AUTHOR), Piffanelli, Pietro (AUTHOR), Raffaello, Tommaso (AUTHOR)
Source: EFSA Journal. Aug2025, Vol. 23 Issue 8, p1-11. 11p.
Subject Terms: *Transgenic organisms, *Environmental monitoring, *Herbicide tolerance of plants, Risk assessment, Regulatory approval
Company/Entity: European Union , European Food Safety Authority , European Commission
Abstract: Following the submission of dossier GMFF‐2024‐21890 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seeds US LLC, 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 herbicide‐tolerant genetically modified cotton GHB614 × LLCotton25, 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, 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 sequences of the events in cotton GHB614 × LLCotton25 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2024‐21890 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton GHB614 x LLCotton25. [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 cotton GHB614 × LLCotton25 for renewal authorisation under regulation (EC) No 1829/2003 (dossier GMFF‐2024‐21890).
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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="%22Camargo%2C+Ana+M%2E%22">Camargo, Ana M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lenzi%2C+Paolo%22">Lenzi, Paolo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Piffanelli%2C+Pietro%22">Piffanelli, Pietro</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Raffaello%2C+Tommaso%22">Raffaello, Tommaso</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Aug2025, Vol. 23 Issue 8, p1-11. 11p.
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  Data: *<searchLink fieldCode="DE" term="%22Transgenic+organisms%22">Transgenic organisms</searchLink><br />*<searchLink fieldCode="DE" term="%22Environmental+monitoring%22">Environmental monitoring</searchLink><br />*<searchLink fieldCode="DE" term="%22Herbicide+tolerance+of+plants%22">Herbicide tolerance of plants</searchLink><br /><searchLink fieldCode="DE" term="%22Risk+assessment%22">Risk assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Regulatory+approval%22">Regulatory approval</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22European+Union%22">European Union</searchLink> <br /><searchLink fieldCode="DE" term="%22European+Food+Safety+Authority%22">European Food Safety Authority</searchLink> <br /><searchLink fieldCode="DE" term="%22European+Commission%22">European Commission</searchLink>
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  Label: Abstract
  Group: Ab
  Data: Following the submission of dossier GMFF‐2024‐21890 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seeds US LLC, 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 herbicide‐tolerant genetically modified cotton GHB614 × LLCotton25, 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, 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 sequences of the events in cotton GHB614 × LLCotton25 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2024‐21890 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton GHB614 x LLCotton25. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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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.2025.9572
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        Text: English
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