Division 6.4 Section IV: studies concerning the efficacy of the additive

Where the additive is already approved for a physiologically comparable major species for the same function and where the mode of action of the additive is known or demonstrated, evidence of the same mode of action in the minor species can be taken as evidence of efficacy. Where no such link can be made, efficacy shall be demonstrated following the general rules for Section IV in Annex II. In some cases it may be appropriate to combine animal species in the same productive stage (e.g. goats and sheep used for milk production). Significance should be demonstrated in each study (P ≤ 0,1) or, if possible, by meta-analysis (P ≤ 0,05).

If efficacy demonstration is required, the duration of efficacy studies shall be analogous to the comparable production stages of the physiologically comparable major species. In other cases, the minimum study duration shall follow the relevant provisions in subsection 4.4 of Annex II and Annex IV.