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      Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)

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          Abstract

          Following the submission of application EFSA‐GMO‐RX‐024 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of EFSA 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 MS8, RF3 and MS8 × RF3, 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 sequences of the events in oilseed rape MS8, RF3 and MS8 × RF3 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐024 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS8 × RF3.

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          Guidance on allergenicity assessment of genetically modified plants

          Abstract This document provides supplementary guidance on specific topics for the allergenicity risk assessment of genetically modified plants. In particular, it supplements general recommendations outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013. The topics addressed are non‐IgE‐mediated adverse immune reactions to foods, in vitro protein digestibility tests and endogenous allergenicity. New scientific and regulatory developments regarding these three topics are described in this document. Considerations on the practical implementation of those developments in the risk assessment of genetically modified plants are discussed and recommended, where appropriate.
            Bookmark
            • Record: found
            • Abstract: not found
            • Article: not found

            Application of systematic review methodology to food and feed safety assessments to support decision making

            (2010)
              Bookmark
              • Record: found
              • Abstract: not found
              • Article: not found

              Guidance on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed

              (2011)
                Bookmark

                Author and article information

                Contributors
                nif@efsa.europa.eu
                Journal
                EFSA J
                EFSA J
                10.1002/(ISSN)1831-4732
                EFS2
                EFSA Journal
                John Wiley and Sons Inc. (Hoboken )
                1831-4732
                26 April 2023
                April 2023
                : 21
                : 4 ( doiID: 10.1002/efs2.v21.4 )
                : e07934
                Author notes
                [*] [* ] Correspondence: nif@ 123456efsa.europa.eu
                Article
                EFS27934
                10.2903/j.efsa.2023.7934
                10131089
                0e677828-87a8-4517-966b-27bbcb0581c5
                © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.

                History
                Page count
                Figures: 0, Tables: 3, Pages: 14, Words: 6906
                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                April 2023
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.2.7 mode:remove_FC converted:26.04.2023

                oilseed rape,ms8,rf3,ms8 × rf3,renewal,articles 11 and 23,regulation (ec) no 1829/2003

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