Specific effects on the reproductive function including fertility relevant for cumulative risk assessment of pesticide residues.

According to the 'EFSA-SANTE Action Plan on Cumulative Risk Assessment for pesticides residues', EFSA, with the support of a working group, undertook the identification of specific effects on male and female reproductive function, including fertility, that are considered relevant for grouping pesticide residues and for assessing retrospectively the cumulative risk (CRA) deriving from consumers' dietary exposure. In this first report, two specific effects leading to two correspondent cumulative assessment groups (CAGs) were identified for male reproduction, namely, (1) altered mating performance and (2) decreased fertility. Four distinct CAGs were proposed for grouping chemicals affecting female reproduction: (1) altered mating performance, (2) decreased fertility, (3) altered gestation and (4) altered parturition. EFSA also defined the list of indicators (i.e. toxicological endpoints measurable in regulatory studies) describing each specific effect. Qualitative and quantitative information on these indicators will be collected from the toxicological assessment reports on individual pesticide active substances: indicators will be used to determine the inclusion of prioritised active substances and their metabolites into the respective CAG and to estimate the no observed adverse effect level (NOAEL) and lowest observed adverse effect level (LOAEL) of each chemical in relation to the given specific effect. Additional endpoints (named ancillary findings), not sufficiently informative to define a specific effect but contributing to the overall evidence, will be collected for a limited number of substances identified as risk drivers, based on hazard and exposure considerations, to support the estimation of CAG-membership probabilities. Additional criteria for including active substances into CAGs, the hazard characterisation methodology and the lines of evidence for assessing CAG-membership probabilities are detailed in this report, which was sent for public consultation. The process of data extraction and actual establishment of the CAGs are instead beyond the scope of this report. This part of the CRA process was outsourced and will be dealt with in a separate report.