Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)

Abstract Following the submission of dossier GMFF‐2022‐9450 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV, 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 re...

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Main Authors: EFSA Panel on Genetically Modified Organisms (GMO), Ewen Mullins, Jean‐Louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst, Michelle M. Epstein, Leslie George Firbank, Philippe Guerche, Jan Hejatko, Francisco Javier Moreno, Hanspeter Naegeli, Fabien Nogué, Nils Rostoks, Jose Juan Sánchez Serrano, Giovanni Savoini, Eve Veromann, Fabio Veronesi, Ana M. Camargo, Tilemachos Goumperis, Paolo Lenzi, Pietro Piffanelli, Tommaso Raffaello
Format: Article
Language:English
Published: Wiley 2024-01-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2024.8489
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author EFSA Panel on Genetically Modified Organisms (GMO)
Ewen Mullins
Jean‐Louis Bresson
Tamas Dalmay
Ian Crawford Dewhurst
Michelle M. Epstein
Leslie George Firbank
Philippe Guerche
Jan Hejatko
Francisco Javier Moreno
Hanspeter Naegeli
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Ana M. Camargo
Tilemachos Goumperis
Paolo Lenzi
Pietro Piffanelli
Tommaso Raffaello
author_facet EFSA Panel on Genetically Modified Organisms (GMO)
Ewen Mullins
Jean‐Louis Bresson
Tamas Dalmay
Ian Crawford Dewhurst
Michelle M. Epstein
Leslie George Firbank
Philippe Guerche
Jan Hejatko
Francisco Javier Moreno
Hanspeter Naegeli
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Ana M. Camargo
Tilemachos Goumperis
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‐2022‐9450 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV, 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 protected genetically modified maize MON 810, for food and feed uses (including pollen), 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, 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 MON 810 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in dossier GMFF‐2022‐9450 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 810.
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spelling doaj-art-53cb1c82c23a4595b07d42e64bcffbaf2024-11-13T07:31:25ZengWileyEFSA Journal1831-47322024-01-01221n/an/a10.2903/j.efsa.2024.8489Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)EFSA Panel on Genetically Modified Organisms (GMO)Ewen MullinsJean‐Louis BressonTamas DalmayIan Crawford DewhurstMichelle M. EpsteinLeslie George FirbankPhilippe GuercheJan HejatkoFrancisco Javier MorenoHanspeter NaegeliFabien NoguéNils RostoksJose Juan Sánchez SerranoGiovanni SavoiniEve VeromannFabio VeronesiAna M. CamargoTilemachos GoumperisPaolo LenziPietro PiffanelliTommaso RaffaelloAbstract Following the submission of dossier GMFF‐2022‐9450 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV, 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 protected genetically modified maize MON 810, for food and feed uses (including pollen), 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, 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 MON 810 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in dossier GMFF‐2022‐9450 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 810.https://doi.org/10.2903/j.efsa.2024.8489Articles 11 and 23maizeMON 810Regulation (EC) No 1829/2003renewal
spellingShingle EFSA Panel on Genetically Modified Organisms (GMO)
Ewen Mullins
Jean‐Louis Bresson
Tamas Dalmay
Ian Crawford Dewhurst
Michelle M. Epstein
Leslie George Firbank
Philippe Guerche
Jan Hejatko
Francisco Javier Moreno
Hanspeter Naegeli
Fabien Nogué
Nils Rostoks
Jose Juan Sánchez Serrano
Giovanni Savoini
Eve Veromann
Fabio Veronesi
Ana M. Camargo
Tilemachos Goumperis
Paolo Lenzi
Pietro Piffanelli
Tommaso Raffaello
Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)
EFSA Journal
Articles 11 and 23
maize
MON 810
Regulation (EC) No 1829/2003
renewal
title Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)
title_full Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)
title_fullStr Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)
title_full_unstemmed Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)
title_short Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF‐2022‐9450)
title_sort assessment of genetically modified maize mon 810 for renewal authorisation under regulation ec no 1829 2003 dossier gmff 2022 9450
topic Articles 11 and 23
maize
MON 810
Regulation (EC) No 1829/2003
renewal
url https://doi.org/10.2903/j.efsa.2024.8489
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