Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21234)

Abstract Following the submission of dossier GMFF‐2023‐21234 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 r...

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Main Authors: EFSA Panel on Genetically Modified Organisms (GMO), Josep Casacuberta, Francisco Barro, Albert Braeuning, Ruud deMaagd, Michelle M. Epstein, Thomas Frenzel, Jean‐Luc Gallois, Frits Koning, Antoine Messéan, F. Javier Moreno, Fabien Nogué, Giovanni Savoini, Alan H. Schulman, Christoph Tebbe, Eve Veromann, Ana M. Camargo, Paolo Lenzi, Pietro Piffanelli, Tommaso Raffaello
Format: Article
Language:English
Published: Wiley 2025-05-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2025.9377
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author EFSA Panel on Genetically Modified Organisms (GMO)
Josep Casacuberta
Francisco Barro
Albert Braeuning
Ruud deMaagd
Michelle M. Epstein
Thomas Frenzel
Jean‐Luc Gallois
Frits Koning
Antoine Messéan
F. Javier Moreno
Fabien Nogué
Giovanni Savoini
Alan H. Schulman
Christoph Tebbe
Eve Veromann
Ana M. Camargo
Paolo Lenzi
Pietro Piffanelli
Tommaso Raffaello
author_facet EFSA Panel on Genetically Modified Organisms (GMO)
Josep Casacuberta
Francisco Barro
Albert Braeuning
Ruud deMaagd
Michelle M. Epstein
Thomas Frenzel
Jean‐Luc Gallois
Frits Koning
Antoine Messéan
F. Javier Moreno
Fabien Nogué
Giovanni Savoini
Alan H. Schulman
Christoph Tebbe
Eve Veromann
Ana M. Camargo
Paolo Lenzi
Pietro Piffanelli
Tommaso Raffaello
author_sort EFSA Panel on Genetically Modified Organisms (GMO)
collection DOAJ
description Abstract Following the submission of dossier GMFF‐2023‐21234 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 herbicide‐tolerant genetically modified cotton MON 88913, 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 sequence of the event in cotton MON 88913 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‐2023‐21234 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton MON 88913.
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spelling doaj-art-e417f6a67c1a437ca4d751f9a21233572025-08-20T02:16:50ZengWileyEFSA Journal1831-47322025-05-01235n/an/a10.2903/j.efsa.2025.9377Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21234)EFSA Panel on Genetically Modified Organisms (GMO)Josep CasacubertaFrancisco BarroAlbert BraeuningRuud deMaagdMichelle M. EpsteinThomas FrenzelJean‐Luc GalloisFrits KoningAntoine MesséanF. Javier MorenoFabien NoguéGiovanni SavoiniAlan H. SchulmanChristoph TebbeEve VeromannAna M. CamargoPaolo LenziPietro PiffanelliTommaso RaffaelloAbstract Following the submission of dossier GMFF‐2023‐21234 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 herbicide‐tolerant genetically modified cotton MON 88913, 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 sequence of the event in cotton MON 88913 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‐2023‐21234 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton MON 88913.https://doi.org/10.2903/j.efsa.2025.9377Articles 11 and 23cottonMON88913Regulation (EC) No 1829/2003renewal
spellingShingle EFSA Panel on Genetically Modified Organisms (GMO)
Josep Casacuberta
Francisco Barro
Albert Braeuning
Ruud deMaagd
Michelle M. Epstein
Thomas Frenzel
Jean‐Luc Gallois
Frits Koning
Antoine Messéan
F. Javier Moreno
Fabien Nogué
Giovanni Savoini
Alan H. Schulman
Christoph Tebbe
Eve Veromann
Ana M. Camargo
Paolo Lenzi
Pietro Piffanelli
Tommaso Raffaello
Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21234)
EFSA Journal
Articles 11 and 23
cotton
MON88913
Regulation (EC) No 1829/2003
renewal
title Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21234)
title_full Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21234)
title_fullStr Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21234)
title_full_unstemmed Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21234)
title_short Assessment of genetically modified cotton MON 88913 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21234)
title_sort assessment of genetically modified cotton mon 88913 for renewal authorisation under regulation ec no 1829 2003 dossier gmff 2023 21234
topic Articles 11 and 23
cotton
MON88913
Regulation (EC) No 1829/2003
renewal
url https://doi.org/10.2903/j.efsa.2025.9377
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