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Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Soybean DAS‐44406‐6 expresses 5‐enolpyruvyl‐shikimate‐3‐phosphate synthase (2mEPSPS), conferring tolerance to glyphosate‐based herbicides, aryloxyalkanoate dioxygenase (AAD‐12), conferring tolerance to 2,4‐dichlorophenoxyacetic acid (2,4‐D) and other related phenoxy herbicides, and phosphinothricin...

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Autores principales: Naegeli, Hanspeter, Birch, Andrew Nicholas, Casacuberta, Josep, De Schrijver, Adinda, Gralak, Mikołaj Antoni, Jones, Huw, Manachini, Barbara, Messéan, Antoine, Nielsen, Elsa Ebbesen, Nogué, Fabien, Robaglia, Christophe, Rostoks, Nils, Sweet, Jeremy, Tebbe, Christoph, Visioli, Francesco, Wal, Jean‐Michel, Álvarez, Fernando, Ardizzone, Michele, Liu, Yi, Neri, Franco Maria, Ramon, Matthew
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/PMC7009884/
https://www.ncbi.nlm.nih.gov/pubmed/32625444
http://dx.doi.org/10.2903/j.efsa.2017.4738
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author Naegeli, Hanspeter
Birch, Andrew Nicholas
Casacuberta, Josep
De Schrijver, Adinda
Gralak, Mikołaj Antoni
Jones, Huw
Manachini, Barbara
Messéan, Antoine
Nielsen, Elsa Ebbesen
Nogué, Fabien
Robaglia, Christophe
Rostoks, Nils
Sweet, Jeremy
Tebbe, Christoph
Visioli, Francesco
Wal, Jean‐Michel
Álvarez, Fernando
Ardizzone, Michele
Liu, Yi
Neri, Franco Maria
Ramon, Matthew
author_facet Naegeli, Hanspeter
Birch, Andrew Nicholas
Casacuberta, Josep
De Schrijver, Adinda
Gralak, Mikołaj Antoni
Jones, Huw
Manachini, Barbara
Messéan, Antoine
Nielsen, Elsa Ebbesen
Nogué, Fabien
Robaglia, Christophe
Rostoks, Nils
Sweet, Jeremy
Tebbe, Christoph
Visioli, Francesco
Wal, Jean‐Michel
Álvarez, Fernando
Ardizzone, Michele
Liu, Yi
Neri, Franco Maria
Ramon, Matthew
collection PubMed
description Soybean DAS‐44406‐6 expresses 5‐enolpyruvyl‐shikimate‐3‐phosphate synthase (2mEPSPS), conferring tolerance to glyphosate‐based herbicides, aryloxyalkanoate dioxygenase (AAD‐12), conferring tolerance to 2,4‐dichlorophenoxyacetic acid (2,4‐D) and other related phenoxy herbicides, and phosphinothricin acetyl transferase (PAT), conferring tolerance to glufosinate ammonium‐based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food/feed safety. The agronomic and phenotypic characteristics revealed no relevant differences between soybean DAS‐44406‐6 and its conventional counterpart, except for pod count, seed count and yield. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 31%) in lectin activity in soybean DAS‐44406‐6. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition of soybean DAS‐44406‐6 as compared to its conventional counterpart and non‐GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the three newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS‐44406‐6. Soybean DAS‐44406‐6 is as nutritious as its conventional counterpart and the non‐GM soybean reference varieties tested. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS‐44406‐6 plants, unless exposed to the intended herbicides. The likelihood of environmental effects from the accidental release of viable seeds from soybean DAS‐44406‐6 into the environment is therefore very low. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS‐44406‐6. In conclusion, the GMO Panel considers that the information available for soybean DAS‐44406‐6 addresses the scientific comments raised by Member States and that soybean DAS‐44406‐6, as described in this application, is as safe as its conventional counterpart and non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application.
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spelling pubmed-70098842020-07-02 Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 Naegeli, Hanspeter Birch, Andrew Nicholas Casacuberta, Josep De Schrijver, Adinda Gralak, Mikołaj Antoni Jones, Huw Manachini, Barbara Messéan, Antoine Nielsen, Elsa Ebbesen Nogué, Fabien Robaglia, Christophe Rostoks, Nils Sweet, Jeremy Tebbe, Christoph Visioli, Francesco Wal, Jean‐Michel Álvarez, Fernando Ardizzone, Michele Liu, Yi Neri, Franco Maria Ramon, Matthew EFSA J Scientific Opinion Soybean DAS‐44406‐6 expresses 5‐enolpyruvyl‐shikimate‐3‐phosphate synthase (2mEPSPS), conferring tolerance to glyphosate‐based herbicides, aryloxyalkanoate dioxygenase (AAD‐12), conferring tolerance to 2,4‐dichlorophenoxyacetic acid (2,4‐D) and other related phenoxy herbicides, and phosphinothricin acetyl transferase (PAT), conferring tolerance to glufosinate ammonium‐based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food/feed safety. The agronomic and phenotypic characteristics revealed no relevant differences between soybean DAS‐44406‐6 and its conventional counterpart, except for pod count, seed count and yield. The compositional analysis identified no differences requiring further assessment, except for an increase (up to 31%) in lectin activity in soybean DAS‐44406‐6. Such increase is unlikely to raise additional concerns for food/feed safety and nutrition of soybean DAS‐44406‐6 as compared to its conventional counterpart and non‐GM reference varieties. There were no concerns regarding the potential toxicity and allergenicity of the three newly expressed proteins, and no evidence that the genetic modification might significantly change the overall allergenicity of soybean DAS‐44406‐6. Soybean DAS‐44406‐6 is as nutritious as its conventional counterpart and the non‐GM soybean reference varieties tested. There are no indications of an increased likelihood of establishment and spread of occasional feral soybean DAS‐44406‐6 plants, unless exposed to the intended herbicides. The likelihood of environmental effects from the accidental release of viable seeds from soybean DAS‐44406‐6 into the environment is therefore very low. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS‐44406‐6. In conclusion, the GMO Panel considers that the information available for soybean DAS‐44406‐6 addresses the scientific comments raised by Member States and that soybean DAS‐44406‐6, as described in this application, is as safe as its conventional counterpart and non‐GM soybean reference varieties with respect to potential effects on human and animal health and the environment in the context of the scope of this application. John Wiley and Sons Inc. 2017-03-21 /pmc/articles/PMC7009884/ /pubmed/32625444 http://dx.doi.org/10.2903/j.efsa.2017.4738 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
Jones, Huw
Manachini, Barbara
Messéan, Antoine
Nielsen, Elsa Ebbesen
Nogué, Fabien
Robaglia, Christophe
Rostoks, Nils
Sweet, Jeremy
Tebbe, Christoph
Visioli, Francesco
Wal, Jean‐Michel
Álvarez, Fernando
Ardizzone, Michele
Liu, Yi
Neri, Franco Maria
Ramon, Matthew
Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
title Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
title_full Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
title_fullStr Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
title_full_unstemmed Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
title_short Scientific opinion on an application by Dow AgroSciences LLC (EFSA‐GMO‐NL‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean DAS‐44406‐6 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
title_sort scientific opinion on an application by dow agrosciences llc (efsa‐gmo‐nl‐2012‐106) for the placing on the market of genetically modified herbicide‐tolerant soybean das‐44406‐6 for food and feed uses, import and processing under regulation (ec) no 1829/2003
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009884/
https://www.ncbi.nlm.nih.gov/pubmed/32625444
http://dx.doi.org/10.2903/j.efsa.2017.4738
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