Division 3.3.2.1 Metabolic and residue studies

Metabolic studies normally are not required. For urea derivatives, ruminal metabolism shall be studied in the efficacy trials.

Residue or deposition studies are only required for those additives that fall within the functional group ‘vitamins, pro-vitamins and chemically well-defined substances, having similar effect’ that have a potential for accumulation in the body and for the functional group of compounds of trace elements where bioavailability has been enhanced. In that case, the procedure described in subsection 3.2.1 of Annex II does not apply. The requirement is limited to the comparison of the levels in the tissues or products between the group supplemented with the highest dose of the substance claimed and a positive control (reference compound).