1.An evaluation report under Article 8 must include the competent authority's reasoned opinion on, in particular, the risks to the consumer and where relevant to animals associated with the setting, modification or deletion of an MRL.
2.The reasoned opinion must include—
(a)an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes;
(b)the anticipated LOD for the pesticide/product combination;
(c)an assessment of the risks of the acceptable daily intake or acute reference dose being exceeded as a result of the modification of the MRL;
(d)the contribution to the acceptable daily intake due to the residues in the product for which the MRL was requested;
(e)any other element relevant to the risk assessment.
3.The reasoned opinion must clearly define the basis for each conclusion reached.
4.The competent authority may request supplementary information from the applicant where necessary for the giving of a reasoned opinion.]
Textual Amendments