TY - JOUR
T1 - Assessment of genetically modified maize 1507 × NK603 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-008)
AU - European Food Safety Authority Panel on Genetically Modified Organisms
AU - Naegeli, Hanspeter
AU - Birch, Andrew Nicholas
AU - Casacuberta, Josep
AU - De Schrijver, Adinda
AU - Gralak, Mikołaj Antoni
AU - Guerche, Philippe
AU - Jones, Huw
AU - Manachini, Barbara
AU - Messéan, Antoine
AU - Nielsen, Elsa Ebbesen
AU - Nogué, Fabien
AU - Robaglia, Christophe
AU - Rostoks, Nils
AU - Sweet, Jeremy
AU - Tebbe, Christoph
AU - Visioli, Francesco
AU - Wal, Jean Michel
AU - Álvarez, Fernando
AU - Ardizzone, Michele
AU - De Sanctis, Giacomo
AU - Fernandez Dumont, Antonio
AU - Ruiz Gómez, José Ángel
AU - Lanzoni, Anna
AU - Papadopoulou, Nikoletta
AU - Paraskevopoulos, Konstantinos
N1 - Publisher Copyright:
© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
PY - 2018/7/25
Y1 - 2018/7/25
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).
KW - 1507 × NK603
KW - Articles 11 and 23
KW - Maize
KW - Regulation (EC) No 1829/2003
KW - renewal
UR - http://www.scopus.com/inward/record.url?scp=85062221854&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2018.5347
DO - 10.2903/j.efsa.2018.5347
M3 - Article
AN - SCOPUS:85062221854
SN - 1831-4732
VL - 16
JO - EFSA Journal
JF - EFSA Journal
IS - 7
M1 - e05347
ER -