Proposal for a data model for probabilistic cumulative dietary exposure assessments of pesticides in line with the MCRA software

In specific contract No 4 issued under the framework agreement GP/EFSA/PRAS/2014/02 to Support the Regulatory Implementation of Cumulative Exposure Assessment of Pesticides, EFSA requested RIVM and its subcontractor Wageningen University & Research, Biometris to propose a data model organising the information related to specific elements of cumulative dietary exposure assessment for pesticides, which were toxicological information (i.e., cumulative assessment groups and substance potency information related to the specific effect), the authorisation status of plant protection products over time (per pesticide/commodity combination at national level), the use frequency of plant protection products over time (per pesticide/commodity combination at national level), the MRL in force over time, extrapolation rules according to the ad-hoc EC guidance, processing data (mean and individual values), and residue definitions for monitoring and risk assessment (possibly related to groups of commodities). The data model proposed in this report standardises how the data elements relate to one another, and allows the automation of main regulatory modelling assumptions, settings and default values when information is missing. The proposed data model is compatible with the format of data and coding rules of the EFSA standard sample description (SSD) and the EFSA DWH

Dietary cumulative acute risk assessment of organophosphorus, carbamates and pyrethroids insecticides for the Brazilian population.

Cumulative acute dietary risk assessments of organophosphorus (OPs), carbamates (CBs) and pyrethroids (PYs) were conducted for the Brazilian population. Residue data for 30786 samples of 30 foods were obtained from two national monitoring programs and one University laboratory, and consumption data from a national survey conducted among persons 10 years or older. Acephate and methamidophos were used as index compounds (IC) for OPs, oxamyl for CBs and deltamethrin for PYs. Exposures were estimated using the Monte Carlo Risk Assessment (MCRA 8.2) software. Orange and orange juice (mainly containing methidathion), pasta and salted bread (mainly pirimiphos-methyl) contributed most to the OPs intake. Rice accounted for 80% of the CBs intake (teenagers), mainly due to aldicarb. Pasta, salted bread and beans contributed most to the PYs intake (9-14%), mainly due to bifenthrin. The intake did not exceed the ARfD at the 99.9th percentile for OPs, CBs and PYs, and the risks from the exposure were not considered of health concern. When food consumption data become available for children under age 10, studies in the cumulative exposure should be conducted, as this age group is the most critical among the population, mainly due to their higher food consumption per kg body weight

Cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using MCRA software

In the context of the second framework partnership agreement between the National Institute for Public Health and the Environment of the Netherlands (RIVM) and the European Food Safety Authority (EFSA)acute cumulative dietary exposure assessments were performed for two cumulative assessment groups (CAGs) of pesticidesthat affect the nervous system: pesticides associated with brain and/or erythrocyte AChE inhibition (CAG-NAN, 47 pesticides) and pesticides associated with functional alterations of the motor division (CAG-NAM, 100 pesticides). The exposure assessments used pesticide monitoring data collected by Member States under their official 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. Exposure estimates were obtained for each group of pesticides by means of a 2-dimensional Monte Carlo simulation, which was implemented in the Monte Carlo Risk Assessment (MCRA) software.The scope of the assessment and the parameters to be used for cumulative exposure assessment were discussed and agreed by the Standing Committee on Plants, Animals, Food and Feed (SC PAFF). Based on those discussions, a very conservative tier I modelling approach and a refined, but still conservative tier II modelling approach were used. In these assessments, common risk assessment practice was followed and the cumulative exposure was calculated as total margin of exposure (MOET) at the 50th, 90th, 95th, 99th and 99.9th percentiles of the exposure distribution. Five sensitivity analyses aiming to address major uncertainties were performed. The exposure estimates obtained in this report are used in EFSA's scientific report on the cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system

Oral intake of added titanium dioxide and its nanofraction from food products, food supplements and toothpaste by the Dutch population

Titanium dioxide (TiO2) is commonly applied to enhance the white colour and brightness of food products. TiO2 is also used as white pigment in other products such as toothpaste. A small fraction of the pigment is known to be present as nanoparticles (NPs). Recent studies with TiO2 NPs indicate that these particles can have toxic effects. In this paper, we aimed to estimate the oral intake of TiO2 and its NPs from food, food supplements and toothpaste in the Dutch population aged 2 to over 70 years by combining data on food consumption and supplement intake with concentrations of Ti and TiO2 NPs in food products and supplements. For children aged 2–6 years, additional intake via ingestion of toothpaste was estimated. The mean long-term intake to TiO2 ranges from 0.06 mg/kg bw/day in elderly (70+), 0.17 mg/kg bw/day for 7–69-year-old people, to 0.67 mg/kg bw/day in children (2–6 year old). The estimated mean intake of TiO2 NPs ranges from 0.19 μg/kg bw/day in elderly, 0.55 μg/kg bw/day for 7–69-year-old people, to 2.16 μg/kg bw/day in young children. Ninety-fifth percentile (P95) values are 0.74, 1.61 and 4.16 μg/kg bw/day, respectively. The products contributing most to the TiO2 intake are toothpaste (in young children only), candy, coffee creamer, fine bakery wares and sauces. In a separate publication, the results are used to evaluate whether the presence of TiO2 NPs in these products can pose a human health risk

Oral intake of added titanium dioxide and its nanofraction from food products, food supplements and toothpaste by the Dutch population

Titanium dioxide (TiO2) is commonly applied to enhance the white colour and brightness of food products. TiO2 is also used as white pigment in other products such as toothpaste. A small fraction of the pigment is known to be present as nanoparticles (NPs). Recent studies with TiO2 NPs indicate that these particles can have toxic effects. In this paper, we aimed to estimate the oral intake of TiO2 and its NPs from food, food supplements and toothpaste in the Dutch population aged 2 to over 70 years by combining data on food consumption and supplement intake with concentrations of Ti and TiO2 NPs in food products and supplements. For children aged 2–6 years, additional intake via ingestion of toothpaste was estimated. The mean long-term intake to TiO2 ranges from 0.06 mg/kg bw/day in elderly (70+), 0.17 mg/kg bw/day for 7–69-year-old people, to 0.67 mg/kg bw/day in children (2–6 year old). The estimated mean intake of TiO2 NPs ranges from 0.19 μg/kg bw/day in elderly, 0.55 μg/kg bw/day for 7–69-year-old people, to 2.16 μg/kg bw/day in young children. Ninety-fifth percentile (P95) values are 0.74, 1.61 and 4.16 μg/kg bw/day, respectively. The products contributing most to the TiO2 intake are toothpaste (in young children only), candy, coffee creamer, fine bakery wares and sauces. In a separate publication, the results are used to evaluate whether the presence of TiO2 NPs in these products can pose a human health risk

Annexes to the external scientific report on the potential impact of prioritisation methods on the outcome of cumulative exposure assessments of pesticides - Hazard information and Total Margin of Exposure (MOET) results

he potential impact of a prioritisation method on the outcome of cumulative exposure assessments of pesticides was evaluated (te Biesebeek et al., 2021). The method aims to reduce the laborious task of the establishment of cumulative assessment groups (CRAs). The prioritisation method consisted of two steps: 1) identification of low-priority substances and 2) identification of priority organs. The first step aimed to identify low-priority substances based on hazard quotient (HQ) thresholds for single substances relevant for acute effects on the nervous system or chronic effects on the thyroid. For this, probabilistic calculations of chronic and acute HQs were performed for 210 substances and 10 surveys. Priority pesticides were retained according to four different thresholds, namely an HQ larger than 0.1 at the 99th percentile of exposure, or an HQ larger than 0.01, 0.1 or 0.2 at the 99.9th percentile of exposure. In the second step, AGs for the nervous system and the thyroid were compiled and risk metrics obtained for those organs was compared with the risk of higher tier AGs at the specific effect. It was concluded that risk assessment of AGs at the target organ level using critical effects (i.e. using the health-based guidance value of substances) is feasible. The prioritisation thresholds were applied for AGs at the target organ level and for AGs at the specific effect level. The prioritisation threshold of having an HQ larger than 0.1 at 99.9th percentile to retain substances could be used for those AGs. It reduced the number of substances in the AG nervous system to 50% and the number of substances in the AG thyroid to 70% without having a substantial impact on the total margin of exposure. In conclusion, the prioritisation method could be used to simplify CRA and may contribute to a cost-effective approach whilst still providing a high level of protection

Replacement of meat and dairy by plant-derived foods:estimated effects on land use, iron and SFA intakes in young Dutch adult females

<p>Objective: Reduction in the current high levels of meat and dairy consumption may contribute to environmental as well as human health. Since meat is a major source of Fe, effects on Fe intake need to be evaluated, especially in groups vulnerable to negative Fe status. In the present study we evaluated the effects of replacing meat and dairy foods with plant-based products on environmental sustainability (land requirement) and health (SFA and Fe intakes) in women.</p><p>Design: Data on land requirements were derived from existing calculation methods. Food composition data were derived from the Dutch Food Composition Table 2006. Data were linked to the food consumption of young Dutch women. Land requirements and nutrient intakes were evaluated at baseline and in two scenarios in which 30% (Scenario_30 %) or 100% (Scenario_100 %) of the dairy and meat consumption was randomly replaced by the same amount of plant-based dairy-and meat-replacing foods.</p><p>Setting: The Netherlands.</p><p>Subjects: Three hundred and ninety-eight young Dutch females.</p><p>Results: Replacement of meat and dairy by plant-based foods benefited the environment by decreasing land use. The intake of SFA decreased considerably compared with the baseline situation. On average, total Fe intake increased by 2.5 mg/d, although most of the Fe intake was from a less bioavailable source.</p><p>Conclusions: Replacement of meat and dairy foods by plant-based foods reduced land use for consumption and SFA intake of young Dutch females and did not compromise total Fe intake.</p>