TY - JOUR
T1 - Assessment of genetically modified maize MON 810 for renewal authorisation under Regulation (EC) No 1829/2003 (dossier GMFF-2022-9450)
AU - EFSA Panel on Genetically Modified Organisms (GMO)
AU - Mullins, Ewen
AU - Bresson, Jean Louis
AU - Dalmay, Tamas
AU - Dewhurst, Ian Crawford
AU - Epstein, Michelle M.
AU - Firbank, Leslie George
AU - Guerche, Philippe
AU - Hejatko, Jan
AU - Moreno, Francisco Javier
AU - Naegeli, Hanspeter
AU - Nogué, Fabien
AU - Rostoks, Nils
AU - Sánchez Serrano, Jose Juan
AU - Savoini, Giovanni
AU - Veromann, Eve
AU - Veronesi, Fabio
AU - M. Camargo, Ana
AU - Goumperis, Tilemachos
AU - Lenzi, Paolo
AU - Piffanelli, Pietro
AU - Raffaello, Tommaso
N1 - Publisher Copyright:
© 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
PY - 2024/1
Y1 - 2024/1
N2 - 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.
AB - 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.
KW - Articles 11 and 23
KW - MON 810
KW - Regulation (EC) No 1829/2003
KW - maize
KW - renewal
UR - https://www.scopus.com/pages/publications/85182997940
U2 - 10.2903/j.efsa.2024.8489
DO - 10.2903/j.efsa.2024.8489
M3 - Article
AN - SCOPUS:85182997940
SN - 1831-4732
VL - 22
JO - EFSA Journal
JF - EFSA Journal
IS - 1
M1 - e8489
ER -