3.3. Additional elements

The following elements should be taken into account in safety assessment:

  • Methodological peculiarities - techniques used for genetic modification; characterization and verification of expected protein expression product of the novel DNA; strain identification and characterization (recipient, donor, GMM itself)
  • Host strain - natural habitat; history of use by humans; pathogenic potential; safety and nutritional assessment (potential toxicity and nutritional aspects)
  • Environmental events – gene transfer and genetic stability
  • GMMs derived food - composition of food containing GMM; effects of processing, cooking and storage
  • GMM - interaction between GMM, the gastrointestinal flora and the mammalian host; impact on the immune system


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