The provisions of Annex II, Section 6, Introduction apply.
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.
The objectives of these studies are:
to quantify the highest likely residue levels in treated crops at harvest or outloading from store following the proposed good agricultural practice (GAP),
and
to determine, when appropriate, the rate of decline of pesticide deposits.
Supplementary residue trials 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, point 6.3. This might be the case for special formulations, for special application methods or for crops 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.
The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.3 apply.
The objective of these studies is to determine the residue in products of animal origin which will result from residues in feedingstuffs or fodder crops.
Supplementary feeding studies for the purpose of assessing maximum residue levels for products of animal origin are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.4. This might be the case where additional fodder crops are to be authorized which leads to an increased intake of residues of 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.
The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.4 apply.
The main objectives of these studies are:
to establish whether or not breakdown or reaction products arise from residues in the raw products during processing which may require a separate risk assessment,
to determine the quantitative distribution of residues in the various intermediate and end products, and to estimate transfer factors,
to enable a more realistic estimate to be made of dietary intake of residues.
Supplementary 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, point 6.5. This might be the case for crops 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.
The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.5 apply.
The objective of these studies is to permit an evaluation of possible residues in succeeding crops.
Supplementary studies are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.6. This might be the case for special formulations, for special application methods or for crops 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.
The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.6 apply.
A full justification for the proposed MRLs must be provided, including, where relevant, full details of the statistical analysis used.
If the metabolism studies submitted in accordance with the provisions of point 8.1 indicate that the residue definition should be changed taking into account the actual residue definition and the necessary judgement as outlined under the corresponding paragraph of Annex II, Section 6, point 6.7, a re-evaluation of the active substance may be necessary.
A full justification for the proposals must be provided.
Consideration will be given to the calculation of a realistic prediction of dietary intake. This may be done in a step-wise fashion leading to an increasingly realistic prediction of intake. Where relevant, other sources of exposure such as residues arising from the use of medicines or veterinary drugs have to be taken into account.
A summary and evaluation of all data presented in this Section should be carried out according to the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations. It should include a detailed and critical assessment of those data in the context of relevant evaluative and decision-making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base.
Where metabolism data have been submitted the toxicological significance of any non-mammalian metabolites must be addressed.
A schematic diagram should be prepared of the metabolic pathway in plants and animals with a brief explanation of the distribution and chemical changes involved if metabolism data have been submitted.]