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Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)

Genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 was developed by crossing to combine six single events: Bt11, MIR162, MIR604, MON 89034, 5307 and GA21, the GMO Panel previously assessed the 6 single maize events and 27 out of the 56 possible subcombinations and did not id...

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Autores principales: Mullins, Ewen, Bresson, Jean‐Louis, Dalmay, Tamas, Dewhurst, Ian Crawford, Epstein, Michelle M, Firbank, Leslie George, Guerche, Philippe, Hejatko, Jan, Moreno, Francisco Javier, Naegeli, Hanspeter, Nogué, Fabien, Rostoks, Nils, Sánchez Serrano, Jose Juan, Savoini, Giovanni, Veromann, Eve, Veronesi, Fabio, Ardizzone, Michele, De Sanctis, Giacomo, Federici, Silvia, Fernandez, Antonio, Gennaro, Andrea, Gómez Ruiz, José Ángel, Goumperis, Tilemachos, Kagkli, Dafni Maria, Lenzi, Paolo, Camargo, Ana M, Neri, Franco Maria, Raffaello, Tommaso
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10240405/
https://www.ncbi.nlm.nih.gov/pubmed/37284025
http://dx.doi.org/10.2903/j.efsa.2023.8011
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author Mullins, Ewen
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Naegeli, Hanspeter
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Ardizzone, Michele
De Sanctis, Giacomo
Federici, Silvia
Fernandez, Antonio
Gennaro, Andrea
Gómez Ruiz, José Ángel
Goumperis, Tilemachos
Kagkli, Dafni Maria
Lenzi, Paolo
Camargo, Ana M
Neri, Franco Maria
Raffaello, Tommaso
author_facet Mullins, Ewen
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Naegeli, Hanspeter
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Ardizzone, Michele
De Sanctis, Giacomo
Federici, Silvia
Fernandez, Antonio
Gennaro, Andrea
Gómez Ruiz, José Ángel
Goumperis, Tilemachos
Kagkli, Dafni Maria
Lenzi, Paolo
Camargo, Ana M
Neri, Franco Maria
Raffaello, Tommaso
collection PubMed
description Genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 was developed by crossing to combine six single events: Bt11, MIR162, MIR604, MON 89034, 5307 and GA21, the GMO Panel previously assessed the 6 single maize events and 27 out of the 56 possible subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the six‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that six‐event stack maize, as described in this application, is as safe as the conventional counterpart and non‐GM maize varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable six‐event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in 29 of the maize subcombinations not previously assessed and covered by the scope of this application and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the six‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21. The GMO Panel concludes that six‐event stack maize and the 30 subcombinations covered by the scope of the application are as safe as its conventional counterpart and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment.
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spelling pubmed-102404052023-06-06 Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149) Mullins, Ewen Bresson, Jean‐Louis Dalmay, Tamas Dewhurst, Ian Crawford Epstein, Michelle M Firbank, Leslie George Guerche, Philippe Hejatko, Jan Moreno, Francisco Javier Naegeli, Hanspeter Nogué, Fabien Rostoks, Nils Sánchez Serrano, Jose Juan Savoini, Giovanni Veromann, Eve Veronesi, Fabio Ardizzone, Michele De Sanctis, Giacomo Federici, Silvia Fernandez, Antonio Gennaro, Andrea Gómez Ruiz, José Ángel Goumperis, Tilemachos Kagkli, Dafni Maria Lenzi, Paolo Camargo, Ana M Neri, Franco Maria Raffaello, Tommaso EFSA J Scientific Opinion Genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 was developed by crossing to combine six single events: Bt11, MIR162, MIR604, MON 89034, 5307 and GA21, the GMO Panel previously assessed the 6 single maize events and 27 out of the 56 possible subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the six‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that six‐event stack maize, as described in this application, is as safe as the conventional counterpart and non‐GM maize varieties tested, and no post‐market monitoring of food/feed is considered necessary. In the case of accidental release of viable six‐event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in 29 of the maize subcombinations not previously assessed and covered by the scope of this application and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the six‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21. The GMO Panel concludes that six‐event stack maize and the 30 subcombinations covered by the scope of the application are as safe as its conventional counterpart and the tested non‐GM maize varieties with respect to potential effects on human and animal health and the environment. John Wiley and Sons Inc. 2023-06-05 /pmc/articles/PMC10240405/ /pubmed/37284025 http://dx.doi.org/10.2903/j.efsa.2023.8011 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH 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
Mullins, Ewen
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Naegeli, Hanspeter
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Ardizzone, Michele
De Sanctis, Giacomo
Federici, Silvia
Fernandez, Antonio
Gennaro, Andrea
Gómez Ruiz, José Ángel
Goumperis, Tilemachos
Kagkli, Dafni Maria
Lenzi, Paolo
Camargo, Ana M
Neri, Franco Maria
Raffaello, Tommaso
Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)
title Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)
title_full Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)
title_fullStr Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)
title_full_unstemmed Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)
title_short Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and 30 subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2018‐149)
title_sort assessment of genetically modified maize bt11 × mir162 × mir604 × mon 89034 × 5307 × ga21 and 30 subcombinations, for food and feed uses, under regulation (ec) no 1829/2003 (application efsa‐gmo‐de‐2018‐149)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10240405/
https://www.ncbi.nlm.nih.gov/pubmed/37284025
http://dx.doi.org/10.2903/j.efsa.2023.8011
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