Division 1 Introduction

For the purposes of this Annex, the definitions of Council Regulation (EEC) No 2377/90^f1 shall apply.

The purpose of studying the depletion of residues from the edible tissues or of eggs, milk and honey derived from treated animals is to determine under what conditions and to what extent residues may persist in foodstuffs produced from these animals. In addition, the studies shall enable the determination of a withdrawal period.

In the case of veterinary medicinal products intended for use in food-producing animals, the residue documentation shall show:

1. (1)

   to what extent, and how long, do residues of the veterinary medicinal product or its metabolites persist in the edible tissues of the treated animal or in milk, eggs and/or honey obtained therefrom;

2. (2)

   that in order to prevent any risk to the health of the consumer of foodstuffs from treated animals, or difficulties in the industrial processing of foodstuffs, it is possible to establish realistic withdrawal periods which can be observed under practical farming conditions;

3. (3)

   that the analytical method(s) used in the residues depletion study are sufficiently validated to provide the necessary reassurance that the residues data submitted are suitable as the basis for a withdrawal period.