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4 results for “Cumulative risk assessment”
Annexes to the EFSA external scientific report "Proposed prospective scenarios for cumulative risk assessment of pesticide residues"
<p>In the context of prospective cumulative risk assessment of pesticides, different options and scenarios for a tiered approach were investigated by means of 15 case studies for the cumulative assessment group associated with an effect on the motor division of the nervous system (CAG-NAM) and 15 case studies for the cumulative assessment group associated with an effect on hypothyroidism (CAG-TCF) (doi:10.2903/sp.efsa.2021.EN-6811). The results of the prospective exposure calculations are reported in the following annexes:</p> <p><strong>Annex A</strong>: Acute exposure calculations - CAG-NAM</p> <p><strong>Annex B</strong>: Chronic exposure calculations - CAG-TCF</p> <p><strong>Annex C</strong>: Results supporting the discussion on prospective acute scenarios - CAG-NAM</p> <p><strong>Annex D</strong>: Results supporting the discussion on prospective chronic scenarios - CAG-TCF</p> <p>The case studies reported above also include fictitious data, which were included for assessing the relevance of the various parameters in these calculations. The results of these case studies do not represent real estimates of exposure or risk, nor do they represent the formal outcome of a risk assessment.</p>
Annexes to the EFSA external scientific report on the standard regulatory action for retrospective cumulative risk assessment of pesticides in MCRA
<p>Annexes to the EFSA external scientific report on the standard regulatory action for retrospective cumulative risk assessment of pesticides in MCRA.</p> <p>Harmonized methodology for retrospective dietary cumulative risk assessment (CRA) of pesticides was established by the European Commission (EC) and the European Food Safety Authority (EFSA) in 2018, in close collaboration with the Dutch National Institute for Public Health and the Environment (RIVM). An update of this regulatory methodology (RM) was proposed and adopted by EFSA in 2022 in a CRA on craniofacial alterations. This updated RM was implemented in version 10 of the MCRA software and validated as part of the first action defined in the third framework partnership agreements between EFSA and RIVM. This report describes the implementation of this updated methodology in the MCRA software for risk assessment. This is done from a proposed framework of standard regulatory actions (SRAs). SRAs offer a user-friendly and simple to use option for regulators to perform retrospective and prospective CRAs in MCRA according to agreed-upon RMs. In particular, this report provides guidance on the use of an SRA for a retrospective dietary CRA for craniofacial alterations according to the updated RM in MCRA version 10.</p> <p>Detailed results of the comparison between reported by MCRA and EFSA’s SAS® software and MCRA formatted input files for the catalogues and secondary data are presented in the following annexes:</p> <ul> <li>Annex A – Comparison of the MOET at different percentiles reported by MCRA and EFSA’s SAS® software for retrospective dietary CRA of craniofacial alterations. </li> <li> <p>Annex B – Comparison of risk-driver contributions reported by MCRA and EFSA’s SAS® software for retrospective dietary CRA of craniofacial alterations. </p> </li> </ul> <ul> <li> <p>Annex C – MCRA formatted input data file containing the primary entity catalogues for the SRA on retrospective dietary CRA of craniofacial alterations. </p> </li> <li> <p>Annex D – MCRA formatted input data file containing the secondary data for the SRA on retrospective dietary CRA of craniofacial alterations. </p> </li> <li> <p>Annex E – MCRA formatted input data file containing the unit- variability factors for the Tier II calculations of the SRA on retrospective dietary CRA of craniofacial alterations. </p> </li> <li> <p>Annex F – MCRA formatted input data file containing the unit- variability factors for the Tier I calculations of the SRA on retrospective dietary CRA of craniofacial alterations. </p> </li> </ul> <p> </p>
Retrospective cumulative dietary risk assessment of craniofacial alterations by residues of pesticides
<p>EFSA established cumulative assessment groups and conducted retrospective cumulative risk<br> assessments for two types of craniofacial alterations (alterations due to abnormal skeletal<br> development, head soft tissue alterations and brain neural tube defects) for 14 European populations<br> of women in childbearing age. Cumulative acute exposure calculations were performed by probabilistic<br> modelling using monitoring data collected by Member States in 2017, 2018 and 2019. A rigorous<br> uncertainty analysis was performed using expert knowledge elicitation. Considering all sources of<br> uncertainty, their dependencies and differences between populations, it was concluded with varying<br> degrees of certainty that the MOET resulting from cumulative exposure is above 100 for the two types<br> of craniofacial alterations. The threshold for regulatory consideration established by risk managers is<br> therefore not exceeded. Considering the severity of the effects under consideration, it was also<br> assessed whether the MOET is above 500. This was the case with varying levels of certainty for the<br> head soft tissue alterations and brain neural tube defects. However, for the alterations due to<br> abnormal skeletal development, it was found about as likely as not that the MOET is above 500 in<br> most populations. For two populations, it was even found more likely that the MOET is below 500.<br> These results were discussed in the light of the conservatism of the methodological approach.</p> <p>The indicators of craniofacial alterations, input and output data for the exposure assessment are reported in the following annexes:</p> <p>• Annex A – Indicators of craniofacial alterations collected for 85 selected active substances;<br> • Annex B1 – Input data for the exposure assessment of CAG-DACL;<br> • Annex B2 – Input data for the exposure assessment of CAG-DAH;<br> • Annex C1 – Output data for the Tier I exposure assessment of CAG-DAC;<br> • Annex C2 – Output data for the Tier I exposure assessment of CAG-DAH;<br> • Annex D1 – Output data for the Tier II exposure assessment of CAG-DAC;<br> • Annex D2 – Output data for the Tier II exposure assessment of CAG-DAH.</p>
Supplementary material to: Demonstration of a tool to assess cumulative risks from combined exposure to multiple pesticide residues in fruits and vegetables
<p>Supplementary material to: Kruisselbrink, J.W., van der Voet, H., van Lenthe, M.S., de Boer, W.J., Bakker, R. (2023). Demonstration of a tool to assess cumulative risks from combined exposure to multiple pesticide residues in fruits and vegetables. Wageningen University & Research Biometris report 48.01.23. https://doi.org/10.18174/584369. Catalogues and secondary data for the cumulative risk calculations.</p>
ScienceDex guides
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