Scientific Opinion on the annual Post‐Market Environmental Monitoring (PMEM) report from Monsanto Europe S.A. on the cultivation of genetically modified maize MON 810 in 2011

Following the request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the 2011 growing season of maize MON 810 provided by Monsanto Europe S.A. The EFSA GMO Panel already assessed the 2009 and 2010 monitoring reports and followed the same approach as for the assessment of the methodology applied by the applicant for monitoring maize MON 810 in 2011. The EFSA GMO Panel considered the plan for insect‐resistant management and addressed the comments raised by the applicant on its previous recommendations for improving the methodology of the resistance monitoring of target pests. The EFSA GMO Panel also paid particular attention to the design and analysis of the farmer questionnaires. The EFSA GMO Panel notes similar shortcomings in the overall methodology for the post‐market environmental monitoring of maize MON 810 as in the previous monitoring reports. Hence, while the EFSA GMO Panel reiterates its previous recommendations for the improvement of the methodology, it also clarifies and elaborates on those related to the monitoring of resistance evolution in target pests. However, from the data submitted by the applicant, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to maize MON 810 cultivation during the 2011 growing season. The outcomes of the 2011 monitoring report do not invalidate the previous EFSA GMO Panel's scientific opinions on maize MON 810.