Division 4 SECTION IV: STUDIES CONCERNING THE EFFICACY OF THE ADDITIVE

Studies shall demonstrate the efficacy for each proposed use and satisfy at least one of the characteristics set out in Article 5(3) of Regulation (EC) No 1831/2003, according to the categories and functional groups of feed additives as provided by Article 6 and Annex I of the said Regulation. Moreover such studies must permit the evaluation of the efficacy of the additive according to common farming practices in F1Great Britain.

The experimental design used must be justified according to the additive use, animal species and category. When using animals, the trials shall be conducted such that their health and husbandry conditions do not adversely affect the interpretation of the results. The positive and negative effects, both technological and biological, shall be described for each experiment. Absence of effects that impair the distinctive features of animal products shall also be demonstrated. Trials shall ideally be compliant with the criteria established by a recognised, externally-audited, quality assurance scheme. In the absence of such a scheme, evidence shall be provided to show that the work was done by qualified personnel using appropriate facilities and equipment and responsible to a named study director.

The trial protocol shall be carefully drawn up by the study director with regard to general descriptive data, for example methods, apparatus and materials used, details of the species, breed or strain of the animals, their number and the conditions under which they were housed and fed. For all studies involving animals, the experimental conditions shall be described according to 3.1.1.3. Final reports, raw data, study plans and well characterised and identified test substances shall be archived for future reference.

Studies shall be designed to demonstrate the efficacy of the lowest recommended dose of additive by targeting sensitive parameters in comparison to a negative and, optionally, a positive control group. Such studies shall also include the maximum recommended dose, where this is proposed. No single design is recommended, flexibility being provided to allow for scientific discretion in the design and conduct of the studies.

Attention shall also be paid to known or potential biological or chemical interactions between the additive, other additives and/or veterinary medicines and/or components of the diet, where this is relevant to the efficacy of the additive concerned (e.g. compatibility of microbial additive with coccidiostats and histomonostats or organic acid).