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Advisory reports 11.02.2019

Second renewal of the authorisation for import and processing of genetically modified maize Bt11

(CGM/190211-01)
  • The present application (EFSA/GMO/RX/016) concerns the second renewal of the authorisation for import and processing of genetically modified (GM) maize Bt11;
  • GM maize Bt11 was previously authorised for import and processing in 1998, and its authorisation was renewed in 2010;
  • COGEM advised positively on the import and processing of maize Bt11 in 1997, and on the renewal of the authorisation in 2008;
  • GM maize Bt11 expresses the pat and cry1Ab genes;
  • GM maize Bt11 is resistant to certain lepidopteran insects and tolerant to herbicides containing the active ingredient glufosinate-ammonium;
  • In the Netherlands, feral maize populations have never been observed and the appearance of volunteers is rare;
  • In the Netherlands, the wild relative of maize (teosinte) is not present in maize fields and in nature;
  • In conclusion, hybridisation of (GM) maize with other species is impossible;
  • The molecular characterisation of maize Bt11 has been updated and meets the criteria of COGEM;
  • The updated molecular characterisation, literature review and annual monitoring reports do not provide any indication of a potential environmental risk;
  • COGEM is of the opinion that import and processing of maize Bt11 pose a negligible risk to the environment in the Netherlands;
  • COGEM abstains from giving advice on the potential risks of incidental consumption since a food/feed assessment is carried out by other organisations.