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

Maize, 15079NK603, renewal, Articles 11 and 23, Regulation (EC) No 1829/2003
First published in the EFSA Journal
25 juillet 2018
Adopted
20 juin 2018
Type
Scientific Opinion

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).

Panel members at the time of adoption

Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Mikołaj Antoni Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, Elsa Ebbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli and Jean‐Michel Wal.
Panel on Genetically Modified Organisms
Contact
GMO [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5347
EFSA Journal 2018;16(7):5347
Question Number
On request from
European Commission (DG SANTE)