Assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐016) - INRAE - Institut national de recherche pour l’agriculture, l’alimentation et l’environnement Access content directly
Journal Articles EFSA Journal Year : 2020

Assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐016)

Hanspeter Naegeli
  • Function : Author
Jean‐louis Bresson
  • Function : Author
Tamas Dalmay
  • Function : Author
Ian Crawford Dewhurst
  • Function : Author
Michelle M Epstein
  • Function : Author
Leslie George Firbank
  • Function : Author
Philippe Guerche
Jan Hejatko
  • Function : Author
Francisco Javier Moreno
  • Function : Author
Ewen Mullins
  • Function : Author
Fabien Nogué
Nils Rostoks
  • Function : Author
Jose Juan Sánchez Serrano
  • Function : Author
Giovanni Savoini
  • Function : Author
Eve Veromann
  • Function : Author
Fabio Veronesi
  • Function : Author
Fernando Álvarez
  • Function : Author
Michele Ardizzone
  • Function : Author
Tommaso Raffaello
  • Function : Author

Abstract

Following the submission of application EFSA-GMO-RX-016 under Regulation (EC) No 1829/2003 from Syngenta 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 maize Bt11, 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, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. 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 event in maize Bt11 considered for renewal is identical to the sequence of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-016 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize Bt11.
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hal-03327917 , version 1 (04-02-2024)

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. gmo Efsa Panel On Genetically Modified Organisms, Hanspeter Naegeli, Jean‐louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst, et al.. Assessment of genetically modified maize Bt11 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐016). EFSA Journal, 2020, 19, ⟨10.2903/j.efsa.2021.6347⟩. ⟨hal-03327917⟩
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