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Renewal of the consent for import, distribution and retail of genetically modified carnation FLO-40644-6

Advisory reports | 07.07.2016 | CGM/160706-03

  • A consent for import, distribution and retail of FLO-40644-6 in Europe was granted in 2007;
  • The present application (C/NL/04/02_001) concerns renewal of the consent for import, distribution and retail of GM carnation FLO-40644-6;
  • Carnation FLO-40644-6 was produced by Agrobacterium tumefaciens mediated transformation;
  • It expresses the dfr, f3’5’h and suRB genes resulting in a modified flower colour and tolerance to sulfonylurea herbicides;
  • Carnation does not have weedy characteristics, there are no reports of establishment of cut flower carnation varieties in the wild, and carnation cannot fertilise wild relatives under natural conditions;
  • The updated bioinformatic analyses did not include an analysis of all the putative fusion ORFs. The molecular characterization of GM carnation FLO-40644-6 does not meet the current criteria of COGEM;
  • Despite the weaknesses in the molecular characterization, COGEM is of the opinion that import, distribution and retail of FLO-40644-6 pose a negligible risk to the environment because there are no reports of established cut flower carnation varieties and because cut carnation flowers cannot fertilise wild relatives; 
  • The authorisation of FLO-40644-6 will not include the use of the GM carnation as food. Carnation petals are sometimes used to garnish dishes. Therefore, it is likely that in case of unauthorised incidental consumption, only a small amount of FLO-40644-6 would be consumed. The introduced genes do not encode toxic or allergenic products. COGEM is not aware of any reports indicating that incidental consumption of FLO-40644-6 poses a risk to human health. COGEM is of the opinion that FLO-40644-6 poses a negligible risk to human health in case of unauthorised incidental consumption;
  • There is no evidence of establishment of FLO-40644-6 in the wild, or of introgression of the transgenes into wild Dianthus species. There are no indications that the introduced traits alter the fitness of FLO-40644-6;
  • Import, distribution and retail of GM carnation of FLO-40644-6 pose a negligible risk to the European environment and human health.

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