CAC/GL 68-2008 Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals
SECTION 1 - SCOPE
1. This Guideline supports the Principles for the Risk Analysis of Foods Derived from Modern Biotechnology. It addresses safety and nutritional aspects of foods consisting of, or derived from, animals that have a history of safe use as sources of food, and that have been modified by modern biotechnology to exhibit new or altered expression of traits.
2. The development, raising and use of animals for human purposes, and in particular, for use for food, raise a variety of issues beyond food safety. Without prejudice to their legitimacy or importance, or to whether or how the use of recombinant-DNA methods in developing animals for food use might affect those issues, this Guideline addresses only food safety and nutritional issues. It therefore does not address:
• animal welfare;
• ethical, moral and socio-economical aspects;
• environmental risks related to the environmental release of recombinant-DNA animals used in food production;
• the safety of recombinant-DNA animals used as feed, or the safety of animals fed with feed derived from recombinant-DNA animals, plants and microorganisms.
3. The Codex principles of risk analysis, particularly those for risk assessment, are primarily intended to apply to discrete chemical entities such as food additives and pesticide residues, or a specific chemical or microbial contaminant that have identifiable hazards and risks; they are not intended to apply to whole foods as such. Indeed, few foods, whatever their origin, have been assessed scientifically in a manner that would fully characterize all risk associated with the food. Further, many foods contain substances that would likely be found harmful if subjected to conventional approaches to safety testing. Thus, a more focused approach is required where the safety of a whole food is being considered.
