Open AccessAssessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation ( EC ) No 1829/2003 (application EFSA ‐ GMO ‐ RX ‐012)
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,
Papadopoulou Nikoletta,
Paraskevopoulos Konstantinos
Publication year - 2019
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.2019.5597
Subject(s) - context (archaeology) , authorization , european union , microbiology and biotechnology , risk assessment , genetically modified organism , agricultural science , business , toxicology , biology , computer science , genetics , paleontology , computer security , gene , economic policy
Following the submission of application EFSA ‐ GMO ‐ RX ‐012 under Regulation ( EC ) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority ( GMO Panel) 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 T45, 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 sequence of the event in oilseed rape T45 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the renewal application EFSA ‐ GMO ‐ RX ‐012 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape T45.