Update of the 2025 and 2026 standard regulatory actions for prospective and retrospective cumulative dietary risk assessment of pesticides in MCRA

Abstract

Abstract Regulatory concern over human exposure to chemical mixtures has intensified, as individuals are continuously exposed to multiple chemical substances from various sources. Historically, the European Food Safety Authority (EFSA) assesses risks based on individual chemicals or expected co‐occurring groups of chemical substances. Recognizing the need for comprehensive methodology, EFSA and the European Commission (EC) initiated in 2021 the gradual implementation of cumulative risk assessment (CRA) for dietary exposure to mixtures of pesticide residues. To facilitate CRA implementation, the Monte Carlo Risk Assessment (MCRA) platform, developed by Wageningen University & Research (WUR, Biometris) for the Dutch National Institute for Public Health and the Environment (RIVM), was selected as CRA tooling based on its potential to be transparent, accessible and fit‐for‐purpose. In the third Framework Partnership Agreement (FPA3; 2021–2026) between EFSA and RIVM, MCRA has been continuously improved in functionality and interoperability. Additionally, standard regulatory actions (SRAs) were developed to provide user‐friendly access to agreed‐upon methodologies and to simplify CRA execution for regulatory governmental users. This report details enhancements to four SRAs for retrospective and prospective CRA, achieved during the final year of FPA3 (Specific Agreement 4). In short, SRAs for prospective CRA were updated to reflect methodology developed by EFSA, which now include several sensitivity analyses. Furthermore, all SRAs include batch assessment options assessing multiple (selected) populations in one run, updated data needed to perform the calculations, and refinements of the user interface.