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GUIDELINE FOR THE CONDUCT OF FOOD SAFETY ASSESSMENT OF FOODS
DERIVED FROM RECOMBINANT-DNA ANIMALS
CAC/GL 68-2008
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 traits1.
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, hav
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