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      Assessment of genetically modified soybean MON 87701 × MON 89788 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐022)

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          Abstract

          Following the submission of application EFSA‐GMO‐RX‐022 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect‐resistant and herbicide‐tolerant genetically modified soybean MON 87701 × MON 89788, 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 soybean MON 87701 × MON 89788 considered for renewal are identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐022 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87701 × MON 89788.

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

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              Explanatory note on DNA sequence similarity searches in the context of the assessment of horizontal gene transfer from plants to microorganisms

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                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
                19 December 2022
                December 2022
                : 20
                : 12 ( doiID: 10.1002/efs2.v20.12 )
                : e07684
                Author notes
                [*] [* ] Correspondence: nif@ 123456efsa.europa.eu
                Article
                EFS27684
                10.2903/j.efsa.2022.7684
                9761338
                36545567
                2fc1b6ec-2348-42bb-8ce7-fabb1d479ba7
                © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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: 2, Pages: 11, Words: 4714
                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                December 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.2.3 mode:remove_FC converted:19.12.2022

                soybean,mon 87701 × mon 89788,renewal,articles 11 and 23,regulation (ec) no 1829/2003

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