Food safety assessment of GM food

The codex alimentarius guideline for the conduct of food safety assessment of foods produced using recombinant-DNA microorganisms address to the safety and nutritional aspects of GM food.
Recombinant-DNA Microorganism” - means bacteria, yeasts or filamentous fungi in which the genetic material has been changed through in vitro nucleic acid techniques including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles

When a GM food is produced, safety assessments of recombinant-DNA microorganisms should document the use of related microorganisms in foods, the absence of properties known to be characteristic of pathogens in the recombinant-DNA microorganisms or the recipient strains used for constructing the recombinant-DNA microorganisms, and known adverse events involving the recipients.

Framework of safety assessment includes the following:
A) Description of the recombinant-DNA microorganism;
B) Description of the recipient microorganism and its use in food production;
C) Description of the donor organism(s);
D) Description of the genetic modification(s) including vector and construct;
E) Characterization of the genetic modification(s);
F) Safety assessment:

• expressed substances: assessment of potential toxicity and other traits related to pathogenicity;
• compositional analyses of key components;
• evaluation of metabolites;
• effects of food processing;
• assessment of immunological effects;
• assessment of viability and residence of microorganisms in the human gastrointestinal tract;
• antibiotic resistance and gene transfer; and
• nutritional modification

This framework should be in place to ensure food safety of the genetically modified food or its processed product.