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Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)

Following the submission of application EFSA‐GMO‐RX‐024 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, 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 author...

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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, Camargo, Ana M, Fernandez, Antonio, Goumperis, Tilemachos, Lenzi, Paolo, Lewandowska, Aleksandra, Raffaello, Tommaso, Streissl, Franz
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/PMC10131089/
https://www.ncbi.nlm.nih.gov/pubmed/37122285
http://dx.doi.org/10.2903/j.efsa.2023.7934
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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
Camargo, Ana M
Fernandez, Antonio
Goumperis, Tilemachos
Lenzi, Paolo
Lewandowska, Aleksandra
Raffaello, Tommaso
Streissl, Franz
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
Camargo, Ana M
Fernandez, Antonio
Goumperis, Tilemachos
Lenzi, Paolo
Lewandowska, Aleksandra
Raffaello, Tommaso
Streissl, Franz
collection PubMed
description Following the submission of application EFSA‐GMO‐RX‐024 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, 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 the herbicide tolerant genetically modified oilseed rape MS8, RF3 and MS8 × RF3, for food and feed uses, excluding cultivation within the European Union. 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 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 MS8, RF3 and MS8 × RF3 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐024 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS8 × RF3.
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spelling pubmed-101310892023-04-27 Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024) 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 Camargo, Ana M Fernandez, Antonio Goumperis, Tilemachos Lenzi, Paolo Lewandowska, Aleksandra Raffaello, Tommaso Streissl, Franz EFSA J Scientific Opinion Following the submission of application EFSA‐GMO‐RX‐024 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, 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 the herbicide tolerant genetically modified oilseed rape MS8, RF3 and MS8 × RF3, for food and feed uses, excluding cultivation within the European Union. 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 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 MS8, RF3 and MS8 × RF3 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐024 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS8 × RF3. John Wiley and Sons Inc. 2023-04-26 /pmc/articles/PMC10131089/ /pubmed/37122285 http://dx.doi.org/10.2903/j.efsa.2023.7934 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
Camargo, Ana M
Fernandez, Antonio
Goumperis, Tilemachos
Lenzi, Paolo
Lewandowska, Aleksandra
Raffaello, Tommaso
Streissl, Franz
Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)
title Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)
title_full Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)
title_fullStr Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)
title_full_unstemmed Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)
title_short Assessment of genetically modified oilseed rape MS8, RF3 and MS8 × RF3 for renewal authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐024)
title_sort assessment of genetically modified oilseed rape ms8, rf3 and ms8 × rf3 for renewal authorisation under regulation (ec) no 1829/2003 (application efsa‐gmo‐rx‐024)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10131089/
https://www.ncbi.nlm.nih.gov/pubmed/37122285
http://dx.doi.org/10.2903/j.efsa.2023.7934
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