Division 4.1 In vitro studies

For all technological and some sensory additives affecting the characteristics of feed, efficacy shall be demonstrated using a laboratory-based study. The study shall be designed to cover a representative range of materials to which the additive will be applied. Results shall be evaluated preferably by parameter-free tests, and shall demonstrate expected changes with a probability of P ≤ 0,05.

In vitro studies, particularly those which simulate aspects of the gastrointestinal tract, may be used for other types of additives in order to support the efficacy. These studies should be capable of statistical evaluation.