Assessment of genetically modified cotton T304‐40 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2024‐23010).
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| Title: | Assessment of genetically modified cotton T304‐40 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2024‐23010). |
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| 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), Goumperis, Tilemachos (AUTHOR), Lenzi, Paolo (AUTHOR), Camargo, Ana M. (AUTHOR), Piffanelli, Pietro (AUTHOR), Raffaello, Tommaso (AUTHOR) |
| Source: | EFSA Journal. Jul2025, Vol. 23 Issue 7, p1-10. 10p. |
| Subject Terms: | *Herbicide tolerance of plants, *Insecticides, *Transgenic organisms, *Agricultural biotechnology, Cotton, Risk assessment, Regulatory approval |
| Company/Entity: | European Union , European Food Safety Authority |
| Abstract: | Following the submission of dossier GMFF‐2024‐23010 Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed 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 insect resistant and herbicide tolerant genetically modified cotton T304‐40, 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 T304‐40 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‐2024‐23010 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton T304‐40. [ABSTRACT FROM AUTHOR] |
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| Database: | GreenFILE |
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| Abstract: | Following the submission of dossier GMFF‐2024‐23010 Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed 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 insect resistant and herbicide tolerant genetically modified cotton T304‐40, 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 T304‐40 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‐2024‐23010 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton T304‐40. [ABSTRACT FROM AUTHOR] |
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| ISSN: | 18314732 |
| DOI: | 10.2903/j.efsa.2025.9580 |
