EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, H, Bresson, J-L et al. (18 more authors) (2019) Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-012). EFSA Journal, 17 (2). 5597. ISSN 1831-4732
Abstract
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
Keywords: | oilseed rape; T45; renewal; articles 11 and 23; Regulation (EC) No 1829/2003 |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Biological Sciences (Leeds) > School of Biology (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 08 Apr 2019 09:06 |
Last Modified: | 08 Apr 2019 09:06 |
Status: | Published |
Publisher: | Wiley |
Identification Number: | 10.2903/j.efsa.2019.5597 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:144491 |