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Advisory reports 12.01.2017

Renewal of the authorisation for import and processing of genetically modified oilseed rape MS8, RF3 and MS8xRF3

(CGM/170112-01)
  • The present application (EFSA/GMO/RX/004) concerns the renewal of the authorisation for import and processing for use in feed of genetically modified (GM) oilseed rape MS8, RF3 and MS8xRF3;
  • Oilseed rape MS8xRF3 has previously been authorized for feed, import and processing in 2007 and food in 2013;
  • In 2004, COGEM has advised positively on the cultivation, import and processing of oilseed rape MS8, RF3 and MS8xRF3;
     
  • Oilseed rape MS8, RF3 and MS8xRF3 express genes of a pollination control system, i.e. the barnase gene (present in MS8) which confers male sterility and the barstar gene (present in RF3) which restores male fertility. They also express the bar gene, which confers tolerance to glufosinate-ammonium containing herbicides;
  • Feral oilseed rape populations occur across the Netherlands, with a small number of plants (<25 or less) per location, along distribution routes and handling areas as a result of spillage of oilseed rape seeds during transport and transshipment;
  • Oilseed rape can hybridise with Brassica rapa which is a common plant along Dutch roadsides. To a lesser extent it can also hybridise with Brassica juncea and Brassica oleracea;
  • Stable incorporation of genes from B. napus into wild populations of B. rapa (introgression) may be possible;
     
  • The molecular characterization and bioinformatics analyses of MS8, RF3 and MS8xRF3 have been updated and meet the criteria of COGEM;
  • Oilseed rape MS8, RF3 and MS8xRF3 events themselves do not pose a risk to the environment in the Netherlands;
  • There are no indications that the introduced traits alter the fitness of oilseed rape MS8, RF3 and MS8xRF3 under natural conditions, except in places where glufosinate-ammonium herbicides are used for weed control;
  • In the long term, prolonged use of herbicides may lead to the establishment of feral herbicide tolerant GM B. napus, including plants with stacked events, or feral herbicide tolerant B. rapa harbouring GM traits;
  • The monitoring plan does not meet the minimal requirements for feed, import and processing of MS8, RF3 and MS8xRF3 and should include monitoring along transport routes (including roadsides and railway beddings) and transshipment areas;
  • Because of the insufficient monitoring plan COGEM cannot advise positively on the renewal application for feed, import and processing of MS8, RF3 and MS8xRF3 oil seed rape.