Division 4.2 Short term efficacy studies with animals

Bioavailability studies may be used to demonstrate the extent to which a novel form or source of a nutrient or colorant can substitute for an equivalent additive already approved or established.

Digestion/balance studies may be used in support of animal performance studies to provide evidence of mode of action. In some cases, particularly in relation to environmental benefits, efficacy may be better demonstrated by balance studies and may be used in preference to long term efficacy studies. Such experiments shall use numbers and species/categories of animals appropriate to the conditions of use proposed.

Other short term efficacy studies with animals may be proposed as appropriate, and these may substitute for long term efficacy studies with animals, provided that this is fully justified.