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Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)

Maize MON 87411 was developed to confer resistance to corn rootworms (Diabrotica spp.) by the expression of a modified version of the Bacillus thuringiensis cry3Bb1 gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate‐containing herbicides by the expression of a CP4 5‐enolpyruvyl...

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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, Ardizzone, Michele, De Sanctis, Giacomo, Fernandez Dumont, Antonio, Gennaro, Andrea, Gómez Ruiz, José Angel, Lanzoni, Anna, Neri, Franco Maria, Papadopoulou, Nikoletta, Paraskevopoulos, Konstantinos, Ramon, Matthew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009500/
https://www.ncbi.nlm.nih.gov/pubmed/32625943
http://dx.doi.org/10.2903/j.efsa.2018.5310
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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
Ardizzone, Michele
De Sanctis, Giacomo
Fernandez Dumont, Antonio
Gennaro, Andrea
Gómez Ruiz, José Angel
Lanzoni, Anna
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
Ramon, Matthew
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
Ardizzone, Michele
De Sanctis, Giacomo
Fernandez Dumont, Antonio
Gennaro, Andrea
Gómez Ruiz, José Angel
Lanzoni, Anna
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
Ramon, Matthew
collection PubMed
description Maize MON 87411 was developed to confer resistance to corn rootworms (Diabrotica spp.) by the expression of a modified version of the Bacillus thuringiensis cry3Bb1 gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate‐containing herbicides by the expression of a CP4 5‐enolpyruvylshikimate‐3‐phosphate synthase (cp4 epsps) gene. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87411 and its conventional counterpart were identified. The compositional analysis of maize MON 87411 did not identify differences that required further assessment except for palmitic acid levels in grains from not treated maize MON 87411. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry3Bb1 and CP4 EPSPS proteins, as expressed in maize MON 87411 and found no evidence that the genetic modification might significantly change the overall allergenicity of maize MON 87411. The nutritional impact of maize MON 87411‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that maize MON 87411, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM maize reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87411 grains into the environment, maize MON 87411 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87411. The GMO Panel concludes that maize MON 87411, as described in this application, is as safe as its conventional counterpart and the tested non‐GM maize reference varieties with respect to potential effects on human and animal health and the environment.
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spelling pubmed-70095002020-07-02 Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124) 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 Ardizzone, Michele De Sanctis, Giacomo Fernandez Dumont, Antonio Gennaro, Andrea Gómez Ruiz, José Angel Lanzoni, Anna Neri, Franco Maria Papadopoulou, Nikoletta Paraskevopoulos, Konstantinos Ramon, Matthew EFSA J Scientific Opinion Maize MON 87411 was developed to confer resistance to corn rootworms (Diabrotica spp.) by the expression of a modified version of the Bacillus thuringiensis cry3Bb1 gene and a DvSnf7 dsRNA expression cassette, and tolerance to glyphosate‐containing herbicides by the expression of a CP4 5‐enolpyruvylshikimate‐3‐phosphate synthase (cp4 epsps) gene. The molecular characterisation data and bioinformatics analyses did not identify issues requiring assessment for food and feed safety. No statistically significant differences in the agronomic and phenotypic characteristics tested between maize MON 87411 and its conventional counterpart were identified. The compositional analysis of maize MON 87411 did not identify differences that required further assessment except for palmitic acid levels in grains from not treated maize MON 87411. The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of the Cry3Bb1 and CP4 EPSPS proteins, as expressed in maize MON 87411 and found no evidence that the genetic modification might significantly change the overall allergenicity of maize MON 87411. The nutritional impact of maize MON 87411‐derived food and feed is expected to be the same as those derived from the conventional counterpart and non‐GM commercial reference varieties. The GMO Panel concludes that maize MON 87411, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non‐GM maize reference varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87411 grains into the environment, maize MON 87411 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87411. The GMO Panel concludes that maize MON 87411, as described in this application, is as safe as its conventional counterpart and the tested non‐GM maize reference varieties with respect to potential effects on human and animal health and the environment. John Wiley and Sons Inc. 2018-06-28 /pmc/articles/PMC7009500/ /pubmed/32625943 http://dx.doi.org/10.2903/j.efsa.2018.5310 Text en © 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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
Ardizzone, Michele
De Sanctis, Giacomo
Fernandez Dumont, Antonio
Gennaro, Andrea
Gómez Ruiz, José Angel
Lanzoni, Anna
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
Ramon, Matthew
Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)
title Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)
title_full Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)
title_fullStr Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)
title_full_unstemmed Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)
title_short Assessment of genetically modified maize MON 87411 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2015‐124)
title_sort assessment of genetically modified maize mon 87411 for food and feed uses, import and processing, under regulation (ec) no 1829/2003 (application efsa‐gmo‐nl‐2015‐124)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009500/
https://www.ncbi.nlm.nih.gov/pubmed/32625943
http://dx.doi.org/10.2903/j.efsa.2018.5310
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