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

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 Nogue,Nils Rostoks,Jose Juan Sanchez Serrano,Giovanni Savoini,Eve Veromann, Fabio Veronesi,Ana M. Camargo, Tilemachos Goumperis, Paolo Lenzi, Pietro Piffanelli,Tommaso Raffaello

EFSA journal. European Food Safety Authority(2024)

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摘要
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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关键词
Articles 11 and 23,maize,MON 810,Regulation (EC) No 1829/2003,renewal
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