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Annexes to the external scientific report on the cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using MCRA software - Input and output data sets

Retrospective dietary exposure assessments were conducted for two groups of pesticides that have acute effects on the nervous system:  <ol> <li>brain and/or erythrocyte acetylcholinesterase inhibition (CAG-NAN);</li> <li>functional alterations of the motor division (CAG-NAM).</li> </ol> The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system (<a href="https://doi.org/10.2903/j.efsa.2019.5800">here</a>). The exposure calculations used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from ten populations of consumers from different countries and from different age groups. Regarding the selection of relevant food commodities, the assessment included water, foods for infants and young children and 30 raw primary commodities of plant origin that are widely consumed within Europe. Exposure estimates were obtained with Monte Carlo Risk Assessment (MCRA) software using a 2-dimensional Monte Carlo simulation, which is composed of an inner-loop execution and an outer-loop execution. Variability within the population is modelled through the inner-loop execution and is expressed as a percentile of the exposure distribution. The outer-loop execution is used to derive 95% confidence intervals around those percentiles (reflecting the sampling uncertainty of the input data). Furthermore, calculations were carried out according to a tiered approach. While the first-tier calculations (Tier I) use very conservative assumptions for an efficient screening of the exposure with low risk for underestimation, the second-tier assessment (Tier II) includes assumptions that are more refined but still conservative. For each scenario, exposure estimates were obtained for different percentiles of the exposure distribution and the total margin of exposure (MOET, i.e. the ratio of the toxicological reference dose to the estimated exposure) was calculated at each percentile. The input and output data for the exposure assessment are reported in the following annexes: <ul> <li>Annex A.1 – Input data for the exposure assessment of CAG-NAN</li> <li>Annex A.2 – Input data for the exposure assessment of CAG-NAM</li> <li>Annex B.1 – Output data from the Tier II exposure assessment of CAG-NAN</li> <li>Annex B.2 – Output data from the Tier II exposure assessment of CAG-NAM</li> </ul> Further information on the data, methodologies and interpretation of the results are provided in the external scientific report on the cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using MCRA software (<a href="https://doi.org/10.2903/sp.efsa.2019.en-1708">here</a>). The results reported in this assessment only refer to the exposure and are not an estimation of the actual risks. These exposure estimates should therefore be considered as documentation for the final scientific report on the cumulative risk assessment of dietary exposure to pesticides for their effects on the nervous system (<a href="https://www.efsa.europa.eu/en/consultations/call/public-consultation-scientific-report-cumulative">here</a>). The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation, including all related uncertainties.

Annexes to the external scientific report on the cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using MCRA software - Input and output data sets

Retrospective dietary exposure assessments were conducted for two groups of pesticides that have chronic effects on the thyroid:  <ol> <li>hypertrophy, hyperplasia and neoplasia of C-cells, i.e. affecting the parafollicular cells or the calcitonin system of the thyroid (CAG-TCP);</li> <li>hypothyroidism, i.e. affecting the follicular cells and/or the hormone system of the thyroid (CAG-TCF).</li> </ol> The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the thyroid (<a href="https://doi.org/10.2903/j.efsa.2019.5801">here</a>). The exposure calculations used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from ten populations of consumers from different countries and from different age groups. Regarding the selection of relevant food commodities, the assessment included water, foods for infants and young children and 30 raw primary commodities of plant origin that are widely consumed within Europe. Exposure estimates were obtained with Monte Carlo Risk Assessment (MCRA) software using a 2-dimensional probabilistic method, which is composed of an inner-loop execution and an outer-loop execution. Variability within the population is modelled through the inner-loop execution and is expressed as a percentile of the exposure distribution. The outer-loop execution is used to derive 95% confidence intervals around those percentiles (reflecting the sampling uncertainty of the input data). Furthermore, calculations were carried out according to a tiered approach. While the first-tier calculations (Tier I) use very conservative assumptions for an efficient screening of the exposure with low risk for underestimation, the second-tier assessment (Tier II) includes assumptions that are more refined but still conservative. For each scenario, exposure estimates were obtained for different percentiles of the exposure distribution and the total margin of exposure (MOET, i.e. the ratio of the toxicological reference dose to the estimated exposure) was calculated at each percentile. The input and output data for the exposure assessment are reported in the following annexes: <ul> <li>Annex A.1 – Input data for the exposure assessment of CAG-TCP</li> <li>Annex A.2 – Input data for the exposure assessment of CAG-TCF</li> <li>Annex B.1 – Output data from the Tier II exposure assessment of CAG-TCP</li> <li>Annex B.2 – Output data from the Tier II exposure assessment of CAG-TCF</li> </ul> Further information on the data, methodologies and interpretation of the results are provided in the external scientific report on the cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using MCRA software (<a href="https://doi.org/10.2903/sp.efsa.2019.en-1707">here</a>). The results reported in this assessment only refer to the exposure and are not an estimation of the actual risks. These exposure estimates should therefore be considered as documentation for the final scientific report on the cumulative risk assessment of dietary exposure to pesticides for their effects on the thyroid (<a href="https://www.efsa.europa.eu/en/consultations/call/public-consultation-scientific-report-cumulative">here</a>). The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation, including all related uncertainties.

Annexes to the scientific report on the cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using SAS® software - Input and output data sets

Retrospective dietary exposure assessments were conducted for two groups of pesticides that have chronic effects on the thyroid:  <ol> <li>hypertrophy, hyperplasia and neoplasia of C-cells, i.e. affecting the parafollicular cells or the calcitonin system of the thyroid (CAG-TCP);</li> <li>hypothyroidism, i.e. affecting the follicular cells and/or the hormone system of the thyroid (CAG-TCF).</li> </ol> The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the thyroid (<a href="https://doi.org/10.2903/j.efsa.2019.5801">here</a>). The exposure calculations used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from ten populations of consumers from different countries and from different age groups. Regarding the selection of relevant food commodities, the assessment included water, foods for infants and young children and 30 raw primary commodities of plant origin that are widely consumed within Europe. Exposure estimates were obtained with SAS® software using a 2-dimensional probabilistic method, which is composed of an inner-loop execution and an outer-loop execution. Variability within the population is modelled through the inner-loop execution and is expressed as a percentile of the exposure distribution. The outer-loop execution is used to derive 95% confidence intervals around those percentiles (reflecting the sampling uncertainty of the input data). Furthermore, calculations were carried out according to a tiered approach. While the first-tier calculations (Tier I) use very conservative assumptions for an efficient screening of the exposure with low risk for underestimation, the second-tier assessment (Tier II) includes assumptions that are more refined but still conservative. For each scenario, exposure estimates were obtained for different percentiles of the exposure distribution and the total margin of exposure (MOET, i.e. the ratio of the toxicological reference dose to the estimated exposure) was calculated at each percentile. The input and output data for the exposure assessment are reported in the following annexes: <ul> <li>Annex A.1 – Input data for the exposure assessment of CAG-TCP</li> <li>Annex A.2 – Input data for the exposure assessment of CAG-TCF</li> <li>Annex B.1 – Output data from the Tier I exposure assessment of CAG-TCP</li> <li>Annex B.2 – Output data from the Tier I exposure assessment of CAG-TCF</li> <li>Annex C.1 – Output data from the Tier II exposure assessment of CAG-TCP</li> <li>Annex C.2 – Output data from the Tier II exposure assessment of CAG-TCF</li> </ul> Further information on the data, methodologies and interpretation of the results are provided in the scientific report on the cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using SAS® software (<a href="https://doi.org/10.2903/j.efsa.2019.5763">here</a>). The results reported in this assessment only refer to the exposure and are not an estimation of the actual risks. These exposure estimates should therefore be considered as documentation for the final scientific report on the cumulative risk assessment of dietary exposure to pesticides for their effects on the thyroid (<a href="https://www.efsa.europa.eu/en/consultations/call/public-consultation-scientific-report-cumulative">here</a>). The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation, including all related uncertainties.

Annexes to the scientific report on the cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using SAS® software - Input and output data sets

Retrospective dietary exposure assessments were conducted for two groups of pesticides that have acute effects on the nervous system:  <ol> <li>brain and/or erythrocyte acetylcholinesterase inhibition (CAG-NAN);</li> <li>functional alterations of the motor division (CAG-NAM).</li> </ol> The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system (<a href="https://doi.org/10.2903/j.efsa.2019.5800">here</a>). The exposure calculations used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from ten populations of consumers from different countries and from different age groups. Regarding the selection of relevant food commodities, the assessment included water, foods for infants and young children and 30 raw primary commodities of plant origin that are widely consumed within Europe. Exposure estimates were obtained with SAS® software using a 2-dimensional Monte Carlo simulation, which is composed of an inner-loop execution and an outer-loop execution. Variability within the population is modelled through the inner-loop execution and is expressed as a percentile of the exposure distribution. The outer-loop execution is used to derive 95% confidence intervals around those percentiles (reflecting the sampling uncertainty of the input data). Furthermore, calculations were carried out according to a tiered approach. While the first-tier calculations (Tier I) use very conservative assumptions for an efficient screening of the exposure with low risk for underestimation, the second-tier assessment (Tier II) includes assumptions that are more refined but still conservative. For each scenario, exposure estimates were obtained for different percentiles of the exposure distribution and the total margin of exposure (MOET, i.e. the ratio of the toxicological reference dose to the estimated exposure) was calculated at each percentile. The input and output data for the exposure assessment are reported in the following annexes: <ul> <li>Annex A.1 – Input data for the exposure assessment of CAG-NAN</li> <li>Annex A.2 – Input data for the exposure assessment of CAG-NAM</li> <li>Annex B.1 – Output data from the Tier I exposure assessment of CAG-NAN</li> <li>Annex B.2 – Output data from the Tier I exposure assessment of CAG-NAM</li> <li>Annex C.1 – Output data from the Tier II exposure assessment of CAG-NAN</li> <li>Annex C.2 – Output data from the Tier II exposure assessment of CAG-NAM</li> </ul> Further information on the data, methodologies and interpretation of the results are provided in the scientific report on the cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using SAS® software (<a href="https://doi.org/10.2903/j.efsa.2019.5764">here</a>). The results reported in this assessment only refer to the exposure and are not an estimation of the actual risks. These exposure estimates should therefore be considered as documentation for the final scientific report on the cumulative risk assessment of dietary exposure to pesticides for their effects on the nervous system (<a href="https://www.efsa.europa.eu/en/consultations/call/public-consultation-scientific-report-cumulative">here</a>). The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation, including all related uncertainties.

opencc-by-4.0Oct 2019View details →

Quinolizidine alkaloids in food and feed - annexes on dietary surveys, occurrence data and dietary exposure assessment

Supplementary information to the Scientific opinion on the risks for animal and human health related to the presence of quinolizidine alkaloids in feed and food, in particular in lupins and lupin-derived products Annex A –     Dietary surveys and occurrence data in food submitted to EFSA Annex B –     Occurrence data in feed submitted to EFSA Annex C –     Results of acute dietary exposure assessment to quinolizidine alkaloids

opencc-by-4.0Mar 2024View details →

Annex C - Human dietary exposure assessment

Occurrence data on PCNs in food as considered for exposure assesssment, chronic dietary exposure to PCNs and the contribution of different food groups to the dietary exposure.

opencc-by-4.0Jul 2024View details →

Annex D - Dietary surveys used for chronic dietary exposure assessment

Dietary surveys used for chronic dietary exposure assessment for DMA and MMA, CONTAM Panel Opinion on small organoarsenic species.

opencc-by-4.0Jul 2024View details →

Annex B – Occurrence data on TBBPA and TBBPA derivatives in food submitted to EFSA, dietary surveys per country and age group available in the EFSA Comprehensive Database considered in the exposure assessment, and chronic dietary exposure to TBBPA and the contribution of different food groups to the dietary exposure

This Annex contains the occurrence data submitted to EFSA, the dietary surveys per country and age group, and the chronic dietary exposure to PBDEs and the contribution of different food groups to the dietary exposure related to the Update of the risk assessment of TBBPA and its derivatives in food.

opencc-by-4.0Sep 2024View details →

Dataset related to article: "Health risk assessment for dietary exposure to 3-monochloropropane-1,2-diol, 2-monochloropropane-1,2-diol, and glycidol for Italian consumers"

Excel file containing food consumption data and concentration data in foodstuff used for exposure assessment