Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)

Following the submission of application EFSA-GMO-RX-011 under Regulation (EC) No 1829/2003 fromMonsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority(GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of there...

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Autores: EFSA Panel on Genetically Modified Organisms (GMO), Naegeli, Hanspeter, Bresson, Jean-Louis, Dalmay, Tamas, Dewhurst, Ian, Epstein, Michelle M., Firbank, Leslie George, Guerche, Philippe, Hejatko, Jan, Moreno, F. Javier, Mullins, Ewen, Nogué, Fabien, Rostoks, Nils, Sánchez Serrano, Jose Juan, Savoini, Giovanni, Veromann, Eve, Veronesi, Fabio, Álvarez, Fernando, Ardizzone, Michele, Paraskevopoulos, Konstantinos
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/192123
Acceso en línea:http://hdl.handle.net/10261/192123
Access Level:acceso abierto
Palabra clave:MON 89788
Regulation (EC) No 1829/2003
Articles 11 and 23
Soybean
Renewal
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spelling Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)EFSA Panel on Genetically Modified Organisms (GMO)Naegeli, HanspeterBresson, Jean-LouisDalmay, TamasDewhurst, IanEpstein, Michelle M.Firbank, Leslie GeorgeGuerche, PhilippeHejatko, JanMoreno, F. JavierMullins, EwenNogué, FabienRostoks, NilsSánchez Serrano, Jose JuanSavoini, GiovanniVeromann, EveVeronesi, FabioÁlvarez, FernandoArdizzone, MicheleParaskevopoulos, KonstantinosMON 89788Regulation (EC) No 1829/2003Articles 11 and 23SoybeanRenewalFollowing the submission of application EFSA-GMO-RX-011 under Regulation (EC) No 1829/2003 fromMonsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority(GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of therenewal of authorisation application for the herbicide-tolerant genetically modified soybean MON 89788,for food and feed uses, excluding cultivation within the European Union. The data received in the contextof this renewal application contained post-market environmental monitoring reports, a systematic searchand evaluation of literature, updated bioinformatic analyses and additional documents or studiesperformed by or on behalf of the applicant. The GMO Panel assessed these data for possible newhazards, modified exposure or new scientific uncertainties identified during the authorisation period andnot previously assessed in the context of the original application. Under the assumption that the DNAsequence of the event in soybean MON 89788 considered for renewal is identical to the sequence of theoriginally assessed event, the GMO Panel concludes that there is no evidence in renewal applicationEFSA-GMO-RX-011 for new hazards, modified exposure or scientific uncertainties that would change theconclusions of the original risk assessment on soybean MON 89788.Peer ReviewedJohn Wiley & SonsConsejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]2019201920182019info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10261/192123reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Ingléshttps://doi.org/10.2903/j.efsa.2018.5468Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/1921232026-05-22T06:33:51Z
dc.title.none.fl_str_mv Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)
title Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)
spellingShingle Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)
EFSA Panel on Genetically Modified Organisms (GMO)
MON 89788
Regulation (EC) No 1829/2003
Articles 11 and 23
Soybean
Renewal
title_short Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)
title_full Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)
title_fullStr Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)
title_full_unstemmed Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)
title_sort Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-011)
dc.creator.none.fl_str_mv EFSA Panel on Genetically Modified Organisms (GMO)
Naegeli, Hanspeter
Bresson, Jean-Louis
Dalmay, Tamas
Dewhurst, Ian
Epstein, Michelle M.
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, F. Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Álvarez, Fernando
Ardizzone, Michele
Paraskevopoulos, Konstantinos
author EFSA Panel on Genetically Modified Organisms (GMO)
author_facet EFSA Panel on Genetically Modified Organisms (GMO)
Naegeli, Hanspeter
Bresson, Jean-Louis
Dalmay, Tamas
Dewhurst, Ian
Epstein, Michelle M.
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, F. Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Álvarez, Fernando
Ardizzone, Michele
Paraskevopoulos, Konstantinos
author_role author
author2 Naegeli, Hanspeter
Bresson, Jean-Louis
Dalmay, Tamas
Dewhurst, Ian
Epstein, Michelle M.
Firbank, Leslie George
Guerche, Philippe
Hejatko, Jan
Moreno, F. Javier
Mullins, Ewen
Nogué, Fabien
Rostoks, Nils
Sánchez Serrano, Jose Juan
Savoini, Giovanni
Veromann, Eve
Veronesi, Fabio
Álvarez, Fernando
Ardizzone, Michele
Paraskevopoulos, Konstantinos
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv MON 89788
Regulation (EC) No 1829/2003
Articles 11 and 23
Soybean
Renewal
topic MON 89788
Regulation (EC) No 1829/2003
Articles 11 and 23
Soybean
Renewal
description Following the submission of application EFSA-GMO-RX-011 under Regulation (EC) No 1829/2003 fromMonsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority(GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of therenewal of authorisation application for the herbicide-tolerant genetically modified soybean MON 89788,for food and feed uses, excluding cultivation within the European Union. The data received in the contextof this renewal application contained post-market environmental monitoring reports, a systematic searchand evaluation of literature, updated bioinformatic analyses and additional documents or studiesperformed by or on behalf of the applicant. The GMO Panel assessed these data for possible newhazards, modified exposure or new scientific uncertainties identified during the authorisation period andnot previously assessed in the context of the original application. Under the assumption that the DNAsequence of the event in soybean MON 89788 considered for renewal is identical to the sequence of theoriginally assessed event, the GMO Panel concludes that there is no evidence in renewal applicationEFSA-GMO-RX-011 for new hazards, modified exposure or scientific uncertainties that would change theconclusions of the original risk assessment on soybean MON 89788.
publishDate 2018
dc.date.none.fl_str_mv 2018
2019
2019
2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
http://purl.org/coar/resource_type/c_6501
Publisher's version
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/192123
url http://hdl.handle.net/10261/192123
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv https://doi.org/10.2903/j.efsa.2018.5468
Sí
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv John Wiley & Sons
publisher.none.fl_str_mv John Wiley & Sons
dc.source.none.fl_str_mv reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC
instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str DIGITAL.CSIC. Repositorio Institucional del CSIC
collection DIGITAL.CSIC. Repositorio Institucional del CSIC
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.812455

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