CAC/GL 46-2003 Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombiant-DNA Microorganisms
SECTION 1 – SCOPE
1. This Guideline supports the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology and addresses safety and nutritional aspects of foods produced through the actions of recombinant-DNA microorganisms.1 The recombinant-DNA microorganisms that are used to produce these foods are typically derived using the techniques of modern biotechnology from strains that have a history of safe, purposeful use in food production. However, in instances where the recipient strains do not have a history of safe use their safety will have to be established.2 Such food and food ingredients may contain viable or non-viable recombinant-DNA microorganisms or may be produced by fermentation using recombinant-DNA microorganisms from which the recombinant-DNA microorganisms may have been removed.
2. Recognizing that the following issues may have to be addressed by other bodies or other instruments, this document does not address:
• safety of microorganisms used in agriculture (for plant protection, biofertilizers, in animal feed or food derived from animals fed the feed etc.);
• risks related to environmental releases of recombinant-DNA microorganisms used in food production;
• safety of substances produced by microorganisms that are used as additives or processing aids, including enzymes for use in food production3;
• specific purported health benefits or probiotic effects that may be attributed to the use of microorganisms in food; or
• issues relating to the safety of food production workers handling recombinant-DNA microorganisms.
