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Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/1)

Following the submission of application EFSA‐GMO‐RX‐026/1 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV on behalf of Bayer CropScience LP, the Panel on Genetically Modified Organisms of EFSA was asked to deliver a scientific risk assessment on the data submitted in the context of the...

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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, Camargo, Ana M, Goumperis, Tilemachos, Lenzi, Paolo, Lewandowska, Aleksandra, Raffaello, Tommaso
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9536181/
https://www.ncbi.nlm.nih.gov/pubmed/36237418
http://dx.doi.org/10.2903/j.efsa.2022.7563
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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
Camargo, Ana M
Goumperis, Tilemachos
Lenzi, Paolo
Lewandowska, Aleksandra
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
Camargo, Ana M
Goumperis, Tilemachos
Lenzi, Paolo
Lewandowska, Aleksandra
Raffaello, Tommaso
collection PubMed
description Following the submission of application EFSA‐GMO‐RX‐026/1 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV on behalf of Bayer CropScience LP, the Panel on Genetically Modified Organisms of EFSA was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for foods and food ingredients containing, consisting of, or produced from oilseed rape GT73 with the exception of isolated seed protein, and feed produced from this GM oilseed rape, excluding cultivation in the EU. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and a search for additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in oilseed rape GT73 considered for renewal are identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐026/1 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape GT73.
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spelling pubmed-95361812022-10-12 Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/1) 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 Camargo, Ana M Goumperis, Tilemachos Lenzi, Paolo Lewandowska, Aleksandra Raffaello, Tommaso EFSA J Scientific Opinion Following the submission of application EFSA‐GMO‐RX‐026/1 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV on behalf of Bayer CropScience LP, the Panel on Genetically Modified Organisms of EFSA was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for foods and food ingredients containing, consisting of, or produced from oilseed rape GT73 with the exception of isolated seed protein, and feed produced from this GM oilseed rape, excluding cultivation in the EU. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and a search for additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in oilseed rape GT73 considered for renewal are identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐026/1 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape GT73. John Wiley and Sons Inc. 2022-10-06 /pmc/articles/PMC9536181/ /pubmed/36237418 http://dx.doi.org/10.2903/j.efsa.2022.7563 Text en © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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
Camargo, Ana M
Goumperis, Tilemachos
Lenzi, Paolo
Lewandowska, Aleksandra
Raffaello, Tommaso
Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/1)
title Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/1)
title_full Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/1)
title_fullStr Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/1)
title_full_unstemmed Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/1)
title_short Assessment of genetically modified oilseed rape GT73 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐026/1)
title_sort assessment of genetically modified oilseed rape gt73 for renewal authorisation under regulation (ec) no 1829/2003 (application efsa‐gmo‐rx‐026/1)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9536181/
https://www.ncbi.nlm.nih.gov/pubmed/36237418
http://dx.doi.org/10.2903/j.efsa.2022.7563
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