Division 3.1.1.3 Experimental conditions

The studies shall be reported individually, giving details of all experimental groups. The trial protocol shall be carefully drawn up with regard to general descriptive data. In particular, the following shall be recorded:

1. (1)

   herd or flock: location and size; feeding and rearing conditions, method of feeding; for aquatic species, size and number of tanks or pens at the farm, light conditions and water quality including water temperature and salinity;

2. (2)

   animals: species (for aquatic species intended for human consumption identification shall be made by their colloquial name followed in parenthesis by the Latin binomial), breed, age (size for aquatic species), sex, identification procedure, physiological stage and general health;

3. (3)

   date and exact duration of testing: date and nature of the examinations performed;

4. (4)

   diets: description of manufacture and quantitative composition of the diet(s) in terms of ingredients used, relevant nutrients (analysed values) and energy. Feed intake records;

5. (5)

   concentration of the active substance(s) or agent(s) (and, where that is the case, substances used for comparative purposes) in the feedingstuffs shall be established by a control analysis, using the appropriate recognised methods: reference number(s) of the batches;

6. (6)

   number of test and control groups, number of animals in each group: the number of animals involved in the trials must permit statistical analysis. The methods of statistical evaluation used should be stated. The report shall include all animals and/or experimental units involved in the trials. Cases which cannot be assessed due to a lack or loss of data shall be reported, and their distribution within the groups of animals classified;

7. (7)

   the timing and prevalence of any undesirable consequences of treatment in individuals or groups must be reported (give details of the observation programme used in the study); and

8. (8)

   therapeutic/preventive treatments, if necessary, shall not interact with the proposed mode of action of the additive and shall be recorded individually.