Open AccessAssessment of genetically modified oilseed rape GT 73 for renewal authorisation under Regulation ( EC ) No 1829/2003 (application EFSA ‐ GMO ‐ RX ‐002)
Author(s) -
Naegeli Hanspeter,
Bresson JeanLouis,
Dalmay Tamas,
Dewhurst Ian Crawford,
Epstein Michelle M,
Firbank Leslie George,
Guerche Philippe,
Hejatko Jan,
Moreno Francisco Javier,
Mullins Ewen,
Nogué Fabien,
Rostoks Nils,
Sánchez Serrano Jose Juan,
Savoini Giovanni,
Veromann Eve,
Veronesi Fabio,
Álvarez Fernando,
Ardizzone Michele,
Raffaello Tommaso
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6199
Subject(s) - authorization , context (archaeology) , microbiology and biotechnology , risk assessment , business , toxicology , biology , computer science , computer security , paleontology
Following the submission of application EFSA ‐ GMO ‐ RX ‐002 under Regulation ( EC ) No 1829/2003 from Monsanto Company, the Panel on Genetically Modified Organisms of EFSA ( GMO ) 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 oilseed rape GT 73. 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 sequence of the event in oilseed rape GT 73 considered for renewal of authorisation is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA ‐ GMO ‐ RX ‐002 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape GT 73.