Additional information market authorisation file C/DE/02/09 “Insect resistant maize MON 863 and MON 863 x MON 810”

In 2002, Monsanto requested a market authorisation for the import and processing of the genetically modified maize line MON 863 and the hybrid maize line MON 863 x MON 810. The MON 863 maize line is less sensitive to the corn root worm due to the insertion and expression of the cry3Bb gene. In addition to this, the hybrid maize line is also less sensitive to the European corn borer due to the insertion and expression of the cry1a(B) gene. In June 2002, COGEM advised negatively on the market introduction because a thorough risk analysis could not be made on the basis of the information provided in the file. COGEM is of the opinion that the previously posed additional questions with respect to the molecular characterisation of maize line MON 863 and the hybrid maize line MON 863 x MON 810 have now been sufficiently answered. COGEM is of the opinion that the market authorisation of both maize lines poses a negligible risk to both humans and the environment. Further COGEM notes that the genetically modified maize contains a construct with the nptII gene. According to the Dutch standpoint, as stated in the Integrated Biotechnology Policy Document, the presence of this resistance gene is not permitted in the case of a market introduction of an agricultural crop, although it is permitted in the case of field experiments.