The objectives of these studies are:
to provide an estimate of total terminal residues in the relevant portion of crops at harvest following treatment as proposed,
to quantify the rate of degradation and excretion of the total residue in certain animal products (milk or eggs) and excreta,
to identify the major components of the total terminal residue in crops and in edible animal products respectively,
to indicate the distribution of residues between relevant crop parts and between relevant edible animal products respectively,
to quantify the major components of the residue and to show the efficiency of extraction procedures for these components,
to generate data from which a decision on the need for livestock feeding studies as provided for in point 8.3 can be made,
to decide on the definition and expression of a residue.
Supplementary metabolism studies only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, points 6.1 and 6.2. This might be the case for crops or for livestock for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I or where it could be expected that a different metabolism will occur.
The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, points 6.1 and 6.2 apply.]