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Assessment of genetically modified oilseed rape 73496 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2012‐109)

Oilseed rape 73496 was developed to confer tolerance to the herbicidal active substance glyphosate through the expression of the glyphosate acetyltransferase protein GAT4621. The molecular characterisation data and bioinformatic analyses identify no issues requiring food/feed safety assessment. None...

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Autores principales: Naegeli, Hanspeter, Bresson, Jean‐Louis, Dalmay, Tamas, Dewhurst, Ian Crawford, Epstein, Michelle M, Firbank, Leslie George, Guerche, Philippe, Hejatko, Jan, Moreno, Francisco Javier, Mullins, Ewen, Nogué, Fabien, Rostoks, Nils, Sánchez Serrano, Jose Juan, Savoini, Giovanni, Veromann, Eve, Veronesi, Fabio, Ardizzone, Michele, Devos, Yann, Federici, Silvia, Dumont, Antonio Fernandez, Gennaro, Andrea, Gómez Ruiz, Jose Ángel, Neri, Franco Maria, Papadopoulou, Nikoletta, Paraskevopoulos, Konstantinos, Lanzoni, Anna
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8209597/
https://www.ncbi.nlm.nih.gov/pubmed/34178155
http://dx.doi.org/10.2903/j.efsa.2021.6610
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author Naegeli, Hanspeter
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Ardizzone, Michele
Devos, Yann
Federici, Silvia
Dumont, Antonio Fernandez
Gennaro, Andrea
Gómez Ruiz, Jose Ángel
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
Lanzoni, Anna
author_facet Naegeli, Hanspeter
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Ardizzone, Michele
Devos, Yann
Federici, Silvia
Dumont, Antonio Fernandez
Gennaro, Andrea
Gómez Ruiz, Jose Ángel
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
Lanzoni, Anna
collection PubMed
description Oilseed rape 73496 was developed to confer tolerance to the herbicidal active substance glyphosate through the expression of the glyphosate acetyltransferase protein GAT4621. The molecular characterisation data and bioinformatic analyses identify no issues requiring food/feed safety assessment. None of the identified differences between oilseed rape 73496 and its conventional counterpart in the agronomic/phenotypic endpoints tested needs further assessment. Differences identified in seed composition of oilseed rape 73496 as compared to its conventional counterpart raise no safety and nutritional concerns in the context of the scope of this application. No safety concerns are identified regarding toxicity and allergenicity of the GAT4621 protein as expressed in oilseed rape 73496. No evidence is found that the genetic modification would change the overall allergenicity of oilseed rape 73496. Based on the outcome of the comparative and nutritional assessments, the consumption of oilseed rape 73496 does not represent any nutritional concern, in the context of the scope of this application. The implementation of a post‐market monitoring plan is recommended to confirm the predicted consumption data and to verify that the conditions of use are those considered during the pre‐market risk assessment. In the case of accidental release of viable oilseed rape 73496 seeds into the environment, oilseed rape 73496 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of oilseed rape 73496. The GMO Panel concludes that oilseed rape 73496, as described in this application, is as safe as its conventional counterpart and the non‐genetically modified oilseed rape reference varieties tested with respect to potential effects on human and animal health and the environment.
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spelling pubmed-82095972021-06-25 Assessment of genetically modified oilseed rape 73496 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2012‐109) Naegeli, Hanspeter Bresson, Jean‐Louis Dalmay, Tamas Dewhurst, Ian Crawford Epstein, Michelle M Firbank, Leslie George Guerche, Philippe Hejatko, Jan Moreno, Francisco Javier Mullins, Ewen Nogué, Fabien Rostoks, Nils Sánchez Serrano, Jose Juan Savoini, Giovanni Veromann, Eve Veronesi, Fabio Ardizzone, Michele Devos, Yann Federici, Silvia Dumont, Antonio Fernandez Gennaro, Andrea Gómez Ruiz, Jose Ángel Neri, Franco Maria Papadopoulou, Nikoletta Paraskevopoulos, Konstantinos Lanzoni, Anna EFSA J Scientific Opinion Oilseed rape 73496 was developed to confer tolerance to the herbicidal active substance glyphosate through the expression of the glyphosate acetyltransferase protein GAT4621. The molecular characterisation data and bioinformatic analyses identify no issues requiring food/feed safety assessment. None of the identified differences between oilseed rape 73496 and its conventional counterpart in the agronomic/phenotypic endpoints tested needs further assessment. Differences identified in seed composition of oilseed rape 73496 as compared to its conventional counterpart raise no safety and nutritional concerns in the context of the scope of this application. No safety concerns are identified regarding toxicity and allergenicity of the GAT4621 protein as expressed in oilseed rape 73496. No evidence is found that the genetic modification would change the overall allergenicity of oilseed rape 73496. Based on the outcome of the comparative and nutritional assessments, the consumption of oilseed rape 73496 does not represent any nutritional concern, in the context of the scope of this application. The implementation of a post‐market monitoring plan is recommended to confirm the predicted consumption data and to verify that the conditions of use are those considered during the pre‐market risk assessment. In the case of accidental release of viable oilseed rape 73496 seeds into the environment, oilseed rape 73496 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of oilseed rape 73496. The GMO Panel concludes that oilseed rape 73496, as described in this application, is as safe as its conventional counterpart and the non‐genetically modified oilseed rape reference varieties tested with respect to potential effects on human and animal health and the environment. John Wiley and Sons Inc. 2021-06-17 /pmc/articles/PMC8209597/ /pubmed/34178155 http://dx.doi.org/10.2903/j.efsa.2021.6610 Text en © 2021 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
Bresson, Jean‐Louis
Dalmay, Tamas
Dewhurst, Ian Crawford
Epstein, Michelle M
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, Francisco Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Ardizzone, Michele
Devos, Yann
Federici, Silvia
Dumont, Antonio Fernandez
Gennaro, Andrea
Gómez Ruiz, Jose Ángel
Neri, Franco Maria
Papadopoulou, Nikoletta
Paraskevopoulos, Konstantinos
Lanzoni, Anna
Assessment of genetically modified oilseed rape 73496 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2012‐109)
title Assessment of genetically modified oilseed rape 73496 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2012‐109)
title_full Assessment of genetically modified oilseed rape 73496 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2012‐109)
title_fullStr Assessment of genetically modified oilseed rape 73496 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2012‐109)
title_full_unstemmed Assessment of genetically modified oilseed rape 73496 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2012‐109)
title_short Assessment of genetically modified oilseed rape 73496 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2012‐109)
title_sort assessment of genetically modified oilseed rape 73496 for food and feed uses, under regulation (ec) no 1829/2003 (application efsa‐gmo‐nl‐2012‐109)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8209597/
https://www.ncbi.nlm.nih.gov/pubmed/34178155
http://dx.doi.org/10.2903/j.efsa.2021.6610
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