Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-008)

Barbara Rosy Ines Manachini, Barbara Manachini, Giacomo De Sanctis, Jeremy Sweet, Anna Lanzoni, Elsa Ebbesen Nielsen, Huw Jones, Fabien Nogué, Michele Ardizzone, Fernando Álvarez, Antonio Fernandez Dumont, Philippe Guerche, Nikoletta Papadopoulou, José Ángel Ruiz Gómez, Konstantinos Paraskevopoulos, Christophe Robaglia, Andrew Nicholas Birch, Mikołaj Antoni Gralak, Adinda De Schrijver, Nils RostoksJosep Casacuberta, Antoine Messéan, Christoph Tebbe, Andrew Nicholas Birch, Hanspeter Naegeli, Francesco Visioli, Jean-Michel Wal

Risultato della ricerca: Article

Abstract

Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 × NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained 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. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 × NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 × NK603 (EFSA, 2006).
Lingua originaleEnglish
pagine (da-a)1-11
Numero di pagine11
RivistaTHE EFSA JOURNAL
Volume16
Stato di pubblicazionePublished - 2018

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Zea mays
corn
risk assessment
Uncertainty
uncertainty
Genetically Modified Organisms
Food Safety
Herbicides
Computational Biology
bioinformatics
imports
food safety
Insects
herbicides
genetically modified organisms
breeds
nucleotide sequences
Food
insects

All Science Journal Classification (ASJC) codes

  • Parasitology
  • Food Science
  • Microbiology
  • Animal Science and Zoology
  • veterinary (miscalleneous)
  • Plant Science

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Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-008). / Manachini, Barbara Rosy Ines; Manachini, Barbara; De Sanctis, Giacomo; Sweet, Jeremy; Lanzoni, Anna; Nielsen, Elsa Ebbesen; Jones, Huw; Nogué, Fabien; Ardizzone, Michele; Álvarez, Fernando; Fernandez Dumont, Antonio; Guerche, Philippe; Papadopoulou, Nikoletta; Ruiz Gómez, José Ángel; Paraskevopoulos, Konstantinos; Robaglia, Christophe; Birch, Andrew Nicholas; Gralak, Mikołaj Antoni; De Schrijver, Adinda; Rostoks, Nils; Casacuberta, Josep; Messéan, Antoine; Tebbe, Christoph; Birch, Andrew Nicholas; Naegeli, Hanspeter; Visioli, Francesco; Wal, Jean-Michel.

In: THE EFSA JOURNAL, Vol. 16, 2018, pag. 1-11.

Risultato della ricerca: Article

Manachini, BRI, Manachini, B, De Sanctis, G, Sweet, J, Lanzoni, A, Nielsen, EE, Jones, H, Nogué, F, Ardizzone, M, Álvarez, F, Fernandez Dumont, A, Guerche, P, Papadopoulou, N, Ruiz Gómez, JÁ, Paraskevopoulos, K, Robaglia, C, Birch, AN, Gralak, MA, De Schrijver, A, Rostoks, N, Casacuberta, J, Messéan, A, Tebbe, C, Birch, AN, Naegeli, H, Visioli, F & Wal, J-M 2018, 'Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-008)', THE EFSA JOURNAL, vol. 16, pagg. 1-11.
Manachini, Barbara Rosy Ines ; Manachini, Barbara ; De Sanctis, Giacomo ; Sweet, Jeremy ; Lanzoni, Anna ; Nielsen, Elsa Ebbesen ; Jones, Huw ; Nogué, Fabien ; Ardizzone, Michele ; Álvarez, Fernando ; Fernandez Dumont, Antonio ; Guerche, Philippe ; Papadopoulou, Nikoletta ; Ruiz Gómez, José Ángel ; Paraskevopoulos, Konstantinos ; Robaglia, Christophe ; Birch, Andrew Nicholas ; Gralak, Mikołaj Antoni ; De Schrijver, Adinda ; Rostoks, Nils ; Casacuberta, Josep ; Messéan, Antoine ; Tebbe, Christoph ; Birch, Andrew Nicholas ; Naegeli, Hanspeter ; Visioli, Francesco ; Wal, Jean-Michel. / Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-008). In: THE EFSA JOURNAL. 2018 ; Vol. 16. pagg. 1-11.
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title = "Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-008)",
abstract = "Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 × NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained 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. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 × NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 × NK603 (EFSA, 2006).",
author = "Manachini, {Barbara Rosy Ines} and Barbara Manachini and {De Sanctis}, Giacomo and Jeremy Sweet and Anna Lanzoni and Nielsen, {Elsa Ebbesen} and Huw Jones and Fabien Nogu{\'e} and Michele Ardizzone and Fernando {\'A}lvarez and {Fernandez Dumont}, Antonio and Philippe Guerche and Nikoletta Papadopoulou and {Ruiz G{\'o}mez}, {Jos{\'e} {\'A}ngel} and Konstantinos Paraskevopoulos and Christophe Robaglia and Birch, {Andrew Nicholas} and Gralak, {Mikołaj Antoni} and {De Schrijver}, Adinda and Nils Rostoks and Josep Casacuberta and Antoine Mess{\'e}an and Christoph Tebbe and Birch, {Andrew Nicholas} and Hanspeter Naegeli and Francesco Visioli and Jean-Michel Wal",
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T1 - Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-008)

AU - Manachini, Barbara Rosy Ines

AU - Manachini, Barbara

AU - De Sanctis, Giacomo

AU - Sweet, Jeremy

AU - Lanzoni, Anna

AU - Nielsen, Elsa Ebbesen

AU - Jones, Huw

AU - Nogué, Fabien

AU - Ardizzone, Michele

AU - Álvarez, Fernando

AU - Fernandez Dumont, Antonio

AU - Guerche, Philippe

AU - Papadopoulou, Nikoletta

AU - Ruiz Gómez, José Ángel

AU - Paraskevopoulos, Konstantinos

AU - Robaglia, Christophe

AU - Birch, Andrew Nicholas

AU - Gralak, Mikołaj Antoni

AU - De Schrijver, Adinda

AU - Rostoks, Nils

AU - Casacuberta, Josep

AU - Messéan, Antoine

AU - Tebbe, Christoph

AU - Birch, Andrew Nicholas

AU - Naegeli, Hanspeter

AU - Visioli, Francesco

AU - Wal, Jean-Michel

PY - 2018

Y1 - 2018

N2 - Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 × NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained 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. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 × NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 × NK603 (EFSA, 2006).

AB - Following the submission of application EFSA-GMO-RX-008 under Regulation (EC) No 1829/2003 from Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant, herbicide-tolerant genetically modified maize 1507 × NK603, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained 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. In conclusion, under the assumption that the DNA sequence of the events in maize 1507 × NK603 considered for renewal are identical to the newly reported 1507 sequence and the NK603 sequence of the originally assessed two-event stack maize, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-008 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize 1507 × NK603 (EFSA, 2006).

UR - http://hdl.handle.net/10447/358396

M3 - Article

VL - 16

SP - 1

EP - 11

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

ER -