Annual post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in 2016.

Following a request from the European Commission, EFSA assessed the annual post-market environmental monitoring (PMEM) report for the 2016 growing season of the Cry1Ab-expressing maize event MON 810 provided by Monsanto Europe S.A. Partial compliance with refuge requirements was reported in Spain, as observed in previous years. EFSA reiterates the need to achieve full compliance in areas of high maize MON 810 adoption to delay resistance evolution, and therefore advocates increasing the level of compliance in such areas. Resistance monitoring data do not indicate a decrease in susceptibility to the Cry1Ab protein in the field corn borer populations tested in the 2016 season. However, EFSA identified some methodological and reporting limitations pertaining to resistance monitoring that need improvement in future PMEM reports. No complaints related to corn borer infestation of maize MON 810 were received via the farmer alert system during the 2016 cultivation season. EFSA encourages the consent holder to provide more information on this complementary resistance monitoring tool. The data on general surveillance do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. EFSA reiterates its recommendations on the methodology and analysis of farmer questionnaires, and considers that future literature searches on maize MON 810 performed in the context of annual PMEM reports should follow the guidelines given in the 2017 EFSA explanatory note on literature searching. Moreover, EFSA encourages relevant stakeholders to implement a methodological framework that enables the use of existing networks in the broader context of environmental monitoring. EFSA concludes that no new evidence has been reported in the 2016 PMEM report that would invalidate previous EFSA evaluations on the safety of maize MON 810.