Specific effects on kidneys relevant for performing a dietary cumulative risk assessment of pesticide residues.

In consistency with the 'EFSA-SANTE Action Plan on Cumulative Risk Assessment for pesticides residues' EFSA initiated a retrospective cumulative risk assessment (CRA) of the effects of pesticide residues on the kidneys. EFSA identified the following specific effects on kidneys of relevance for cumulative risk assessment: glomerular injury, tubular injury, tubular crystals, papillary necrosis, interstitial nephritis, pelvis erosion/ulceration, pelvis calculi/crystals, renal preneoplastic and neoplastic lesions, and pelvis preneoplastic and neoplastic lesions. A list of histological indicators was defined and will be used to collect information on these specific effects, as reported in the assessment reports of the different active substances used as plant protections products. The criteria for inclusion of active substances/metabolites into cumulative assessment groups (CAGs) were also defined, together with the hazard characterisation methodology and the lines of evidence for assessing CAG-membership probabilities. Since no acute CAGs for kidney effects are considered appropriate, the cumulative dietary risk assessment will focus on chronic exposure only. The process of data extraction and establishment of the CAGs is beyond the scope of this report. This part of the CRA process was outsourced and will be the subject of a separate report.