This is a statement of the European Food Safety Authority
In this statement the EFSA GMO Panel responds to a request from the European Commission on whether data provided within application RX-MON810 on maize MON810 are sufficient to conclude on the safety of MON810 pollen as or in food and, if it is the case, to confirm MON810 pollen safety.
Data on molecular characterisation did not identify features of maize MON810 pollen with a potential to raise any safety concerns. The EFSA GMO Panel has previously assessed the safety of the Cry1Ab protein in MON810 and the assessment and conclusions of the GMO Panel on safety of the protein Cry1Ab (including toxicity and allergenicity) reached for food/feed aspects also apply to pollen. While the EFSA GMO Panel is not in a position to conclude on the safety of maize pollen in or as food in general, it concludes that the genetic modification in MON810 maize does not constitute an additional health risk if MON810 maize pollen were to replace maize pollen from non-GM maize in or as food.
Following the submission of a request from the European Commission received on 4 October 2011 the EFSA GMO Panel was asked to verify whether data provided within application RX-MON810 where sufficient to positively conclude on the safety of MON810 pollen as or in food and if this is the case to confirm its safety.
In delivering its scientific statement, the GMO Panel considered the data available on the safety of MON810 maize in application RX-MON810, as well as data available on maize pollen in general, and MON810 maize pollen in particular.
The molecular characterisation data established that maize MON810 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 ranged from undetectable to 0.097 μg/g fw, which is lower than levels observed in MON810 maize 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 of the GMO Panel on safety of the protein Cry1Ab (including toxicity and allergenicity) reached for food/feed aspects also apply to pollen.
For maize MON810 grain and forage, the GMO Panel previously concluded, based on data from field trials as presented in application RX-MON810, that maize MON810 is compositionally, phenotypically and agronomically not different from the non-GM counterparts and conventional maize varieties, except for the new trait.
While limited data are available on the compositional and safety characteristics of maize pollen in general and in particular on those of MON810 maize pollen in comparison to non-GM maize pollen, the EFSA GMO Panel considered a range of additional data constituting a weight of evidence approach for the safety of MON810 maize pollen. These data consist of 1) the abovementioned molecular characterization of MON810 maize; 2) its extensive comparative data of agronomic, phenotypic and compositional characteristics, including reproductive traits related to pollen production and viability; and 3) the food and feed safety of MON810 maize and the newly expressed Cry1Ab protein. These data neither indicate potential concerns over the safety of the newly expressed Cry1Ab protein nor the occurrence of unintended effects that could raise safety concerns.
Maize MON810 is intended to be cultivated and used like any conventional maize which was the basis for a theoretical estimate of exposure of consumers to MON810 maize pollen through consumption of honey containing this pollen instead of pollen from non-GM maize. Since the level of exposure was found low, any unexpected, unintended effect of the genetic modification, if it occurred, would not be likely to result in an adverse health effect from honey consumption.
While the EFSA GMO Panel is not in a position to conclude on the safety of maize pollen in or as food in general, it concludes that the genetic modification in MON810 maize does not constitute an additional health risk if MON810 maize pollen were to replace maize pollen from non-GM maize in or as food.