Dietary risk assessment – cumulative and probabilistic approaches

EU legislation states that residues of plant protection products shall not have any harmful effects on human health, taking into account known cumulative and synergistic effects. Knoell Academy offers a course with focus on this topic. The training aims to explain definitions in the field of cumulative and probabilistic risk assessments, to provide an overview on the current status of the implementation, and to explain the possibilities of available software tools (Monte Carlo Risk Assessment – MCRA). We will present model calculations with MCRA in order to discuss the interpretation the results and possible limitations.



  • Legal requirements
  • Setting of Maximum Residue Limits (MRLs)
  • Acute und chronic risk assessment
  • Input data: MRLs, monitoring data, processing data, variability factors, consumption data, food conversion data
  • Toxicological endpoints: ADI, ARfD

Overview and Definitions:

  • Deterministic vs. probabilistic risk assessment
  • Single compound vs. cumulative assessment (and aggregate assessment)
  • Development in the EU: historical overview, milestone publications
  • EFSA Data Warehouse

Theoretical Background – Probabilistic Risk Assessment:

  • Outline of relevant EFSA publications
  • Optimistic vs. pessimistic assumptions in the model
  • Modelling variability and uncertainty
  • Modelling consumption
  • Background exposure vs. exposure through focal commodity
  • Combining consumption and residues by Monte Carlo simulations
  • Interpretation of model outputs and the role of risk managers

Theoretical Background – Cumulative Risk Assessment:

  • Identification of Cumulative Assessment Groups (CAGs)
  • Considerations on mode/mechanism of action
  • Dose addition
  • Established CAGs in the EU and outlook

MCRA Software:

  • Overview and introduction to the software tool
  • Explanation of the data-input masks
  • Presentation of example calculations
  • Interpretation of the results
Target audience: 
Advanced dietary risk assessors
approx. 10

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