Assessment of genetically modified maize NK603 x MON810 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA-GMO-RX-007)

maize, NK603 x MON810, renewal, articles 11 and 23, Regulation (EC) No 1829/2003
First published in the EFSA Journal
26 February 2018
Adopted
24 January 2018
Type
Scientific Opinion

Abstract

Following the submission of application EFSA-GMO-RX-007 under Regulation (EC) No 1829/2003 from Monsanto, 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 the renewal of authorisation application of the herbicide-tolerant and insect-resistant genetically modified maize NK603 x MON810. 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 sequence of the events in maize NK603 x MON810 considered for renewal is identical to the sequence of the originally assessed events, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-007 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize NK603 x MON810.

Substances

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.2018.5163
EFSA Journal 2018;16(2):5163
Question Number
On request from
European Commission (DG SANTE)