Division 2.1.4 Section IV: studies concerning the efficacy of the additive

The whole of Section IV of Annex II applies.

1. (a)

   For substances which, when fed to animals, add colour to food of animal origin:

   changes of the colour of products obtained from animals receiving the additive at the recommended conditions of use shall be measured using the appropriate methodology. It shall be demonstrated that the use of the additive does not adversely affect product stability or organoleptic and nutritional qualities of the food. In principle, if effects of a particular substance on the composition/characteristics of animal products are well documented, then other studies (e.g. bioavailability studies) may provide adequate evidence of efficacy.

2. (b)

   For substances that add or restore colour in feedingstuffs:

   evidence of efficacy shall be provided by adequate laboratory studies reflecting the intended conditions of use in comparison with control feedingstuffs.

3. (c)

   For substances which favourably affect the colour of ornamental fish and birds:

   studies demonstrating the effect(s) shall be performed on animals receiving the additive at the recommended levels of use. Colour changes shall be measured using the appropriate methodology. Evidence of efficacy may also be provided by other experimental studies (e.g. bioavailability) or by reference to scientific literature.