Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)
Résumé
Following the submission of application EFSA-GMO-RX-012 under Regulation (EC) No 1829/2003 fromBayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food SafetyAuthority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in thecontext of the renewal of authorisation application for the herbicide-tolerant genetically modified oilseedrape T45, for food and feed uses, excluding cultivation within the European Union. The data received inthe context of this renewal application contained post-market environmental monitoring reports, asystematic search and evaluation of literature, updated bioinformatic analyses, and additional documentsor studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possiblenew hazards, modified exposure or new scientific uncertainties identified during the authorisation periodand not previously assessed in the context of the original application. Under the assumption that the DNAsequence of the event in oilseed rape T45 considered for renewal is identical to the sequence of theoriginally assessed event, the GMO Panel concludes that there is no evidence in the renewal applicationEFSA-GMO-RX-012 for new hazards, modified exposure or scientific uncertainties that would change theconclusions of the original risk assessment on oilseed rape T45