EU Prospective Dietary Cumulative Risk Assessment (2024)

This standard action is of type: Single value risks

Standard regulatory action (SRA) for running the probabilistic Tier II scenarios for prospective cumulative dietary risk assessment of pesticide residues for a new use of a focal substance/food requiring a new MRL, in accordance with EC working group on cumulative risk assessment definitions. For detailed information on the regulatory methodology and guidance on the use of this SRA see Kruisselbrink et al. (2025).

This SRA uses data collected and prepared by EFSA which were uploaded to MCRA (see Kruisselbrink et al. (2025)). It includes consumption data for population sub-groups of different EU countries and cumulative assessment groups (CAGs) for four acute effects (NAN, NAM, DAC, DAH) and three chronic effects (NCN, TCF and TCP). For calculation of the background exposure, combined occurrence data from all member states based on 3-year monitoring cycles are used. Occurrence data from the cycles 2019-2021 and 2020-2022 are included in this SRA.

For a selected combination of focal food, focal substance, and effect/CAG, the SRA supports assessments for three prospective scenarios: safety of MRL, safety of GAP with 100% use frequency, and safety of GAP with 20% use frequency. These assessments can be performed either on the entire population, or on the sub-group of only the consumers of the focal food. For running the safety of GAP scenarios, users should supply their own focal occurrence data (from field trials) for the selected focal food/substance. In addition, users should supply specific substance conversion factors for allocation of active substance concentrations from the measured concentrations for the focal substance. Data templates for both the deterministic substance conversion factors and the focal food concentrations can be downloaded using the download data template button. When focal substance and focal food are selected, the template will be partly prefilled.

The regulatory methodology prescribes to quantify sampling uncertainty in consumption data and occurrence data by performing a full uncertainty analysis of 100 bootstrap cycles (see EFSA (2022), EFSA (2021), and Kruisselbrink et al. (2023)). The options to run without uncertainty analysis or with limited uncertainty analysis can be used for testing. For assessment of other sources of uncertainties, this SRA includes a sensitivity analyses for assessing the impact of missing processing factors.