Division 4.4 Duration of long term efficacy studies with target animals

Generally, the duration of efficacy trials shall correspond to the application period claimed.

Efficacy trials shall be carried out according to farming practices in F1Great Britain and be of the minimum duration as stated by Annex IV.

If an additive is applied for a specific and shorter period than given by the animal category definition, it shall be administered according to the proposed conditions of use. However, the observation period shall not be shorter than 28 days and shall involve the relevant end-points (e.g., for sows for reproduction number of piglets born alive when considering the gestation period, or the number and weight of weaned piglets when considering the lactation period).

For other species or animal categories for which a minimum duration period of studies was not established in Annex IV, a period of administration shall be taken in to account, according to the proposed conditions of use.