Division 5.4 Section IV: studies concerning the efficacy of the additive

These additives protect the animals from the results of an invasion of Eimeria spp. or Histomonas meleagridis. Importance shall be attached to evidence of the specific effects of the additive (e.g. species controlled) and its prophylactic properties (e.g. reduction in morbidity, mortality, oocyst count and lesion score). Information on the effect on growth and feed conversion (fattening birds, replacement layers and rabbits), effects on hatchability (breeding birds) shall be provided, as appropriate.

The required efficacy data shall derive from three types of target animal experiments:

• artificial single and mixed infections

• natural/artificial infection to simulate use conditions

• actual use conditions in field trials

Experiments with artificial single and mixed infections (e.g. battery cages for poultry) are intended to demonstrate the relative effectiveness against the parasites and do not require replication. Three significant results are required for studies simulating use conditions (e.g. floor pen studies with poultry, battery cage studies with rabbits). Three field studies in which a degree of natural infection is present are also required.