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      Assessment of genetically modified maize MON 89034 × 1507 × NK603 for renewal authorisation under Regulation (EC) No 1829/2003 (application GMFF‐2022‐3670)

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          Abstract

          Following the submission of dossier GMFF‐2022‐3670 under Regulation (EC) No 1829/2003 from Corteva Agriscience Belgium BV and Bayer Agriculture BV, 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 herbicide‐tolerant and insect‐resistant genetically modified maize MON 89034 × 1507 × NK603, 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 a search for 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 maize MON 89034 × 1507 × NK603 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2022‐3670 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × NK603.

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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
                26 April 2024
                April 2024
                : 22
                : 4 ( doiID: 10.1002/efs2.v22.4 )
                : e8716
                Author notes
                [*] [* ] Correspondence: nif@ 123456efsa.europa.eu
                Article
                EFS28716
                10.2903/j.efsa.2024.8716
                11046403
                579b3191-07fa-4c46-b7a8-63f20ac13757
                © 2024 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: 1, Pages: 10, Words: 4500
                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                April 2024
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.4.0 mode:remove_FC converted:26.04.2024

                articles 11 and 23,maize,mon 89034 × 1507 × nk603,regulation (ec) no 1829/2003,renewal

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