Following the submission of an application (EFSA-GMO-NL-2012-107) under Regulation (EC) No 1829/2003 from Monsanto, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on the safety of the genetically modified (GM) maize MON 810 pollen as or in food.
In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-NL-2012-107, other applications related to maize MON 810 submitted in the European Union (EU), scientific comments submitted by the Member States and relevant scientific publications.
The molecular characterisation data established that maize MON 810 expresses the Cry1Ab insecticidal protein under the control of enhanced 35S promoter from Cauliflower mosaic virus and incorporates the maize Hsp70 intron. Bioinformatic analysis of the open reading frames spanning the junctions between the inserted DNA and maize genomic DNA did not raise safety concerns. The stability of the inserted DNA was confirmed over several generations, implying that the integrity of the insert was maintained throughout microsporogenesis and pollen production. Analyses of the levels of newly expressed proteins in various plant tissues did not raise safety concerns. Levels of Cry1Ab in pollen were undetectable or lower than levels observed in maize MON 810 grain and forage.
With regards to the newly expressed Cry1Ab protein, the results of the molecular characterisation indicate that the same Cry1Ab protein is expressed in pollen as in other parts of the plant. Therefore, the assessment and conclusions reached by the GMO Panel on the safety of the protein Cry1Ab, including its potential toxicity and allergenicity, for food/feed aspects also apply to pollen.
While limited data are available on the compositional and safety characteristics of maize pollen in general and pollen of maize MON 810 in particular, the EFSA GMO Panel considered a range of additional data constituting a weight of evidence approach for the safety of maize MON 810 pollen compared with other maize pollen. These data consist of (1) the above-mentioned molecular characterisation of maize MON 810; (2) extensive data on composition and agronomic/phenotypic characteristics in maize MON810, including reproductive traits related to pollen production and viability; and (3) the food and feed safety of maize MON 810 and the newly expressed Cry1Ab protein. These data do not indicate potential concerns over the safety of the newly expressed Cry1Ab protein or the occurrence of unintended effects that could raise safety concerns.
While the EFSA GMO Panel is not in a position to conclude on the safety of maize pollen occurring in or as food in general, it concludes that the genetic modification in maize MON 810 does not constitute an additional health risk if maize MON 810 pollen were to replace maize pollen from non-GM maize in or as food.