Guidance on the establishment of the residue definition for dietary risk assessment

Abstract

This guidance is intended to harmonise the process for the establishment of the residue definition for dietary risk assessment by inclusion/exclusion of residues on the basis of their toxicity and the potential for exposure in the diet. The guidance provides a practical instrument including a combination of scientific tools ((Q)SAR, read across, TTC) and criteria for identification of residues for which hazard identification and characterisation is needed, to characterise pesticide metabolites and to define compounds that should be included in the residue definition for dietary risk assessment. It is proposed to make use of all information available, including mechanistic understanding, in order to support the decision process and to enable the risk assessors to provide the risk manager with detailed information on toxicity and exposure of every single metabolite as well as on the uncertainties connected to the proposal. The guidance document is complemented by three practical case studies which are intended to demonstrate the applicability of the proposed decision scheme.