View in EDS HTML Full Text PDF Full Text

Assessment of genetically modified maize NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21250).

Saved in:
Bibliographic Details
Title: Assessment of genetically modified maize NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21250).
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), Lenzi, Paolo (AUTHOR), M. Camargo, Ana (AUTHOR), Piffanelli, Pietro (AUTHOR), Raffaelo, Tommasso (AUTHOR)
Source: EFSA Journal. Jun2025, Vol. 23 Issue 6, p1-10. 10p.
Subject Terms: *Transgenic organisms, *Environmental monitoring, *Food safety, *Environmental reporting, Nucleotide sequence
Company/Entity: European Food Safety Authority , European Union
Abstract: Following the submission of dossier GMFF‐2023‐21250 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 maize NK603, 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 maize NK603 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application GMFF‐2023‐21250 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize NK603. [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.)
Database: GreenFILE
Full text is not displayed to guests.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
Header DbId: 8gh
DbLabel: GreenFILE
An: 186282585
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Assessment of genetically modified maize NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21250).
– Name: Author
  Label: Authors
  Group: Au
  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="%22Lenzi%2C+Paolo%22">Lenzi, Paolo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22M%2E+Camargo%2C+Ana%22">M. Camargo, Ana</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Piffanelli%2C+Pietro%22">Piffanelli, Pietro</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Raffaelo%2C+Tommasso%22">Raffaelo, Tommasso</searchLink> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22EFSA+Journal%22">EFSA Journal</searchLink>. Jun2025, Vol. 23 Issue 6, p1-10. 10p.
– Name: Subject
  Label: Subject Terms
  Group: Su
  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="%22Food+safety%22">Food safety</searchLink><br />*<searchLink fieldCode="DE" term="%22Environmental+reporting%22">Environmental reporting</searchLink><br /><searchLink fieldCode="DE" term="%22Nucleotide+sequence%22">Nucleotide sequence</searchLink>
– Name: SubjectCompany
  Label: Company/Entity
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22European+Food+Safety+Authority%22">European Food Safety Authority</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‐2023‐21250 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 maize NK603, 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 maize NK603 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application GMFF‐2023‐21250 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize NK603. [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.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=8gh&AN=186282585
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.2903/j.efsa.2025.9505
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 10
        StartPage: 1
    Subjects:
      – SubjectFull: Transgenic organisms
        Type: general
      – SubjectFull: Environmental monitoring
        Type: general
      – SubjectFull: Food safety
        Type: general
      – SubjectFull: Environmental reporting
        Type: general
      – SubjectFull: Nucleotide sequence
        Type: general
      – SubjectFull: European Food Safety Authority
        Type: general
      – SubjectFull: European Union
        Type: general
    Titles:
      – TitleFull: Assessment of genetically modified maize NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2023‐21250).
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Casacuberta, Josep
      – PersonEntity:
          Name:
            NameFull: Barro, Francisco
      – PersonEntity:
          Name:
            NameFull: Braeuning, Albert
      – PersonEntity:
          Name:
            NameFull: de Maagd, Ruud
      – PersonEntity:
          Name:
            NameFull: Epstein, Michelle M.
      – PersonEntity:
          Name:
            NameFull: Frenzel, Thomas
      – PersonEntity:
          Name:
            NameFull: Gallois, Jean‐Luc
      – PersonEntity:
          Name:
            NameFull: Koning, Frits
      – PersonEntity:
          Name:
            NameFull: Messéan, Antoine
      – PersonEntity:
          Name:
            NameFull: Moreno, F. Javier
      – PersonEntity:
          Name:
            NameFull: Nogué, Fabien
      – PersonEntity:
          Name:
            NameFull: Savoini, Giovanni
      – PersonEntity:
          Name:
            NameFull: Schulman, Alan H.
      – PersonEntity:
          Name:
            NameFull: Tebbe, Christoph
      – PersonEntity:
          Name:
            NameFull: Veromann, Eve
      – PersonEntity:
          Name:
            NameFull: Lenzi, Paolo
      – PersonEntity:
          Name:
            NameFull: M. Camargo, Ana
      – PersonEntity:
          Name:
            NameFull: Piffanelli, Pietro
      – PersonEntity:
          Name:
            NameFull: Raffaelo, Tommasso
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 06
              Text: Jun2025
              Type: published
              Y: 2025
          Identifiers:
            – Type: issn-print
              Value: 18314732
          Numbering:
            – Type: volume
              Value: 23
            – Type: issue
              Value: 6
          Titles:
            – TitleFull: EFSA Journal
              Type: main
ResultId 1