3. Concluding remarks

The safety evaluation process should be based on:

  • case by case basis through implementation of series of well defined questions
  • comparative approach to identification of similarities and differences between classically obtained and GMMs foods through application of the concept of substantial equivalence, providing practical means
  • introduction of special considerations regarding intrinsing properties of microorganisms through evaluation of the impact of GMMs on the food matrix
  • application of the concept of substantial equivalence both to the GMM and the food produced through examination of additional parameters like pathogenicity and persistence in the mammalian GI tract
  • consideration of specific uses and exposures to GMM - GMMs could be an integral part of foods in viable or non-viable form
  • evaluation of GMMs should be done in safety and nutritional aspects - microorganisms used in food production possess basic importance for nutritional quality and safety of the product
  • evaluation of the effect of GMMs or their parts on the immune system in mammalian host needs additional consideration - microorganisms in GI tract affect the immune system and the implementation of GMM in food production needs specific safety assessment regarding the used system for manipulation
  • careful evaluation of possible gene transfer from GMM to gut microflora - genetic material from food has the potential for transfer into gut microflora and mammalian cells in vivo
  • strong necessity for history of safe - use in food of host microorganism the used host microorganisms should have a safe status for use in food; a selective marker should be chosen very carefully in respect to safe use, and antimicrobial resistance marker genes should be avoided and excluded in the final GMM

An overview of the suggested future development of the risk assessment process is outlined in Fig. 2

  • LO4 2

Fig. 2. Overview of suggested future development of risk assessment process.


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