EFSA assesses 2010 Post-Market Environmental Monitoring report for MON810 maize

In its assessment of the report, EFSA’s Panel on Genetically Modified Organisms (GMO Panel) concluded that cultivation of the maize MON810 for the 2010 growing season had no adverse effects on human and animal health or the environment. The GMO A genetically modified organism (GMO) is an organism which contains genetic material that has been deliberately altered and which does not occur naturally through breeding or selection Panel also concluded that the outcomes of the PMEM Monitoring of the effects of a new product (e.g. a GM plant) following its release onto the market. This may reveal adverse effects which were not predicted in the risk assessment conducted prior to market release. It stands for post-market environmental monitoring report corroborate the findings of EFSA’s previous assessment on maize MON810 cultivation for the 2009 season. 

During its evaluation of the 2010 report, the GMO Panel noted shortcomings in the methodology used for the monitoring; however, these did not have implications on its overall conclusions on the safety of MON810. In this context, the Panel reiterated several recommendations which it made in September 2011 in its opinion on the MON810 PMEM report for the 2009 cultivation season. These were related to improving data collection, analysis and reporting.

The Panel also verified the literature review that is part of the 2010 PMEM report. It noted that the applicant had not referenced some relevant papers, published from December 2010 onwards, that related to maize MON810 or the insecticidal toxin that it produces. These studies were considered in EFSA’s assessment.

Monitoring is requested by the legislative framework on GM plants and is carried out following rigorous pre-market environmental risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation and risk management The management of risks which have been identified by risk assessment. It includes the planning, implementation and evaluation of any resulting actions taken to protect consumers, animals and the environment decisions related to the authorisation of the GM crop.

• 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 2010