3.2. Specific considerations

The elaboration of the assessment procedure for safety evaluation of food produced from GMMs is subjected to the following important principles:

  • Consideration of health aspects of human population including disadvantaged ones (immune compromised persons, elderly people and infants).
  • Implementation of scientific data as a background of safety assessment and application of good practice in terms of assessment methods. Revision of safety assessment in respect to new data obtained.
  • Detailed characterization of genetic modification procedure - i. e. description of deletion/insertion of DNA sequences, the recipient microorganism, the ultimate donor organism, the vectors applied in GMMs construction; the construct; the GMM obtained.

These principles should be applied taking into account several important reasons for safety assessment of food, manufactured trough application of GMMs:

  • The way of exposure of humans to the food, or GMM itself.
  • Information about possible secondary effect from gene expression, metabolic pathways in host, DNA disruption.
  • Detailed characteristics of nutrient media used (macro and micronutrients) and production of side products: endogen toxicants, allergens and physiologically active substances.
  • Characterization of inherent differences between microbes and plants and effect of food matrix on GMM.

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