Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)

oilseed rape, T45, renewal, articles 11 and 23, Regulation (EC) No 1829/2003
First published in the EFSA Journal
14. Februar 2019
23. Januar 2019
Scientific Opinion


Following the submission of application EFSA‐GMO‐RX‐012 under Regulation (EC) No1829/2003 from BayerCropScienceN.V., the Panelon 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 Panelassessed 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 Panelconcludes 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.

Panel members at the time of adoption

Hanspeter Naegeli, Jean‐Louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst, Michelle Epstein, Leslie George Firbank, Philippe Guerche, Jan Hejatko, Francisco Javier Moreno, Ewen Mullins, Fabien Nogué, Nils Rostoks, Jose Juan Sánchez Serrano, Giovanni Savoini, Eve Veromann and Fabio Veronesi.
Panel on Genetically Modified Organisms
GMO [at]
EFSA Journal 2019;17(2):5597
Question Number
On request from
European Commission