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Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience

In this opinion, the GMO Panel assessed the three‐event stack oilseed rape (OSR) MON 88302 × MS8 × RF3 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the single events combined to produce this three‐event stack OSR and did not identify safety conc...

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Autores principales: Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Guerche, Philippe, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Devos, Yann, Lanzoni, Anna, Olaru, Irina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010135/
https://www.ncbi.nlm.nih.gov/pubmed/32625467
http://dx.doi.org/10.2903/j.efsa.2017.4767
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author Naegeli, Hanspeter
Birch, Andrew Nicholas
Casacuberta, Josep
De Schrijver, Adinda
Gralak, Mikołaj Antoni
Guerche, Philippe
Jones, Huw
Manachini, Barbara
Messéan, Antoine
Nielsen, Elsa Ebbesen
Nogué, Fabien
Robaglia, Christophe
Rostoks, Nils
Sweet, Jeremy
Tebbe, Christoph
Visioli, Francesco
Wal, Jean‐Michel
Devos, Yann
Lanzoni, Anna
Olaru, Irina
author_facet Naegeli, Hanspeter
Birch, Andrew Nicholas
Casacuberta, Josep
De Schrijver, Adinda
Gralak, Mikołaj Antoni
Guerche, Philippe
Jones, Huw
Manachini, Barbara
Messéan, Antoine
Nielsen, Elsa Ebbesen
Nogué, Fabien
Robaglia, Christophe
Rostoks, Nils
Sweet, Jeremy
Tebbe, Christoph
Visioli, Francesco
Wal, Jean‐Michel
Devos, Yann
Lanzoni, Anna
Olaru, Irina
collection PubMed
description In this opinion, the GMO Panel assessed the three‐event stack oilseed rape (OSR) MON 88302 × MS8 × RF3 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the single events combined to produce this three‐event stack OSR and did not identify safety concerns; no new information that would modify the original conclusions was identified. The combination of the single OSR events and of the newly expressed proteins in the three‐event stack OSR does not give rise to food and feed safety and nutrition issues – based on the molecular, agronomic/phenotypic and compositional characteristics. In the case of accidental release of viable OSR MON 88302 × MS8 × RF3 seeds into the environment, the three‐event stack OSR would not raise environmental safety concerns. The GMO Panel therefore concluded that the three‐event stack OSR is as safe and as nutritious as its conventional counterpart and the tested non‐GM reference varieties in the context of the scope of this application. Since no new safety concerns were identified for the previously assessed two‐event stack OSR MS8 × RF3, the GMO Panel considered that its previous conclusions on this subcombination remain valid. For the two subcombinations MON 88302 × MS8 and MON 88302 × RF3 for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their different combinations would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed OSR MS8 × RF3, and OSR MON 88302 × MS8 × RF3. Since the post‐market environmental monitoring plan for the three‐event stack OSR does not include any provisions for two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly.
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spelling pubmed-70101352020-07-02 Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience Naegeli, Hanspeter Birch, Andrew Nicholas Casacuberta, Josep De Schrijver, Adinda Gralak, Mikołaj Antoni Guerche, Philippe Jones, Huw Manachini, Barbara Messéan, Antoine Nielsen, Elsa Ebbesen Nogué, Fabien Robaglia, Christophe Rostoks, Nils Sweet, Jeremy Tebbe, Christoph Visioli, Francesco Wal, Jean‐Michel Devos, Yann Lanzoni, Anna Olaru, Irina EFSA J Scientific Opinion In this opinion, the GMO Panel assessed the three‐event stack oilseed rape (OSR) MON 88302 × MS8 × RF3 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the single events combined to produce this three‐event stack OSR and did not identify safety concerns; no new information that would modify the original conclusions was identified. The combination of the single OSR events and of the newly expressed proteins in the three‐event stack OSR does not give rise to food and feed safety and nutrition issues – based on the molecular, agronomic/phenotypic and compositional characteristics. In the case of accidental release of viable OSR MON 88302 × MS8 × RF3 seeds into the environment, the three‐event stack OSR would not raise environmental safety concerns. The GMO Panel therefore concluded that the three‐event stack OSR is as safe and as nutritious as its conventional counterpart and the tested non‐GM reference varieties in the context of the scope of this application. Since no new safety concerns were identified for the previously assessed two‐event stack OSR MS8 × RF3, the GMO Panel considered that its previous conclusions on this subcombination remain valid. For the two subcombinations MON 88302 × MS8 and MON 88302 × RF3 for which no experimental data were provided, the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their different combinations would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed OSR MS8 × RF3, and OSR MON 88302 × MS8 × RF3. Since the post‐market environmental monitoring plan for the three‐event stack OSR does not include any provisions for two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly. John Wiley and Sons Inc. 2017-04-10 /pmc/articles/PMC7010135/ /pubmed/32625467 http://dx.doi.org/10.2903/j.efsa.2017.4767 Text en © 2017 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 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.
spellingShingle Scientific Opinion
Naegeli, Hanspeter
Birch, Andrew Nicholas
Casacuberta, Josep
De Schrijver, Adinda
Gralak, Mikołaj Antoni
Guerche, Philippe
Jones, Huw
Manachini, Barbara
Messéan, Antoine
Nielsen, Elsa Ebbesen
Nogué, Fabien
Robaglia, Christophe
Rostoks, Nils
Sweet, Jeremy
Tebbe, Christoph
Visioli, Francesco
Wal, Jean‐Michel
Devos, Yann
Lanzoni, Anna
Olaru, Irina
Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience
title Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience
title_full Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience
title_fullStr Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience
title_full_unstemmed Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience
title_short Scientific Opinion on application EFSA‐GMO‐NL‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape MON 88302 × MS8 × RF3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by Monsanto Company and Bayer CropScience
title_sort scientific opinion on application efsa‐gmo‐nl‐2013‐119 for authorisation of genetically modified glufosinate‐ammonium‐ and glyphosate‐tolerant oilseed rape mon 88302 × ms8 × rf3 and subcombinations independently of their origin, for food and feed uses, import and processing submitted in accordance with regulation (ec) no 1829/2003 by monsanto company and bayer cropscience
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010135/
https://www.ncbi.nlm.nih.gov/pubmed/32625467
http://dx.doi.org/10.2903/j.efsa.2017.4767
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