EFSA gave positive opinion for GM maize NK603 x MON810 for renewal of authorization

Date:02-27-2018

The European Food Safety Authority (EFSA) has given a positive safety assessment to the application EFSA-GMO-RX-007 under Regulation (EC) No 1829/2003 from Monsanto Company.

The application from Monsanto is asking for the renewal of authorisation application of the herbicide-tolerant and insect-resistant genetically modified (GM) maize NK603 x MON810. The scope of the renewal application EFSA-GMO-RX-007 is for food and feed uses, import and processing, but excludes cultivation within the European Union (EU).

In delivering its scientific opinion, the GMO Panel took into account application EFSA-GMO-RX-007, additional information provided by the applicant, scientific comments submitted by the Member States and relevant scientific publications. The data received in the context of the renewal application EFSA-GMO-RX-007 contained: post-market environmental monitoring reports, an evaluation of the literature retrieved by a systematic search, 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 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.