Division 3.4 Section IV: studies concerning the efficacy of the additive

Efficacy studies are not required for urea, amino acids, amino acid salts and analogues already authorised as feed additives, compounds of trace elements already authorised as feed additives and vitamins, pro-vitamins and chemically well-defined substances having similar effect already authorised as feed additives.

A short term study is required to support efficacy for urea derivatives, amino acid salts and analogues not already authorised as feed additives, compounds of trace elements not already authorised as feed additives and for vitamins, pro-vitamins and chemically well-defined substances having similar effect not already authorised as feed additives.

For other substances for which a nutritional effect is requested at least one long term efficacy study under provisions of Section 4 of Annex II is requested.

Where required, studies shall demonstrate that the additive can provide the animals' nutritional requirements. Tests shall include a test group with a diet that contains the nutrient at concentrations below the animals' requirements. However, trials using a severely deficient control group shall be avoided. Generally, it will be sufficient to demonstrate efficacy in a single animal species or category including laboratory animals.