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Vin K, Connolly A, McCaffrey T, McKevitt A, O’Mahony C, Prieto M, Tennant D, Hearty A, Volatier JL.
Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2013;30(12):2050-80. doi: 10.1080/19440049.2013.851417. Epub 2013 Dec 4.
04/12/2013

Estimation of the dietary intake of 13 priority additives in France, Italy, the UK and Ireland as part of the FACET project’.

The aim of this study was to assess the dietary exposure of 13 priority additives in four European countries (France, Italy, the UK and Ireland) using the Flavourings, Additives and Contact Materials Exposure Task (FACET) software. The studied additives were benzoates (E210-213), nitrites (E249-250) and sulphites (E220-228), butylated hydroxytoluene (E321), polysorbates (E432-436), sucroses esters and sucroglycerides (E473-474), polyglycerol esters of fatty acids (E475), stearoyl-lactylates (E481-482), sorbitan esters (E493-494 and E491-495), phosphates (E338-343/E450-452), aspartame (E951) and acesulfame (E950). A conservative approach (based on individual consumption data combined with maximum permitted levels (Tier 2)) was compared with more refined estimates (using a fitted distribution of concentrations based on data provided by the food industry (Tier 3)). These calculations demonstrated that the estimated intake is below the acceptable daily intake (ADI) for nine of the studied additives. However, there was a potential theoretical exceedance of the ADI observed for four additives at Tier 3 for high consumers (97.5th percentile) among children: E220-228 in the UK and Ireland, E432-436 and E481-482 in Ireland, Italy and the UK, and E493-494 in all countries. The mean intake of E493-494 could potentially exceed the ADI for one age group of children (aged 1-4 years) in the UK. For adults, high consumers only in all countries had a potential intake higher than the ADI for E493-494 at Tier 3 (an additive mainly found in bakery wares). All other additives examined had an intake below the ADI. Further refined exposure assessments may be warranted to provide a more in-depth investigation for those additives that exceeded the ADIs in this paper. This refinement may be undertaken by the introduction of additive occurrence data, which take into account the actual presence of these additives in the different food groups.

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Kettler Susanne & Marc Kennedy, Cronan McNamara, Regina Oberdörfer, CianO’Mahony, Jürgen Schnabel, Benjamin Smith, Corinne Sprong, Roland Faludi, DavidTennant
Food and Chemical Toxicology – Volume 82, August 2015, Pages 79-95
15/04/2015

Assessing and reporting uncertainties in dietary exposure analysis: Mapping of uncertainties in a tiered approach

Uncertainty analysis is an important component of dietary exposure assessments in order to understand correctly the strength and limits of its results. Often, standard screening procedures are applied in a first step which results in conservative estimates. If through those screening procedures a potential exceedance of health-based guidance values is indicated, within the tiered approach more refined models are applied. However, the sources and types of uncertainties in deterministic and probabilistic models can vary or differ.

A key objective of this work has been the mapping of different sources and types of uncertainties to better understand how to best use uncertainty analysis to generate more realistic comprehension of dietary exposure. In dietary exposure assessments, uncertainties can be introduced by knowledge gaps about the exposure scenario, parameter and the model itself. With this mapping, general and model-independent uncertainties have been identified and described, as well as those which can be introduced and influenced by the specific model during the tiered approach.

This analysis identifies that there are general uncertainties common to point estimates (screening or deterministic methods) and probabilistic exposure assessment methods. To provide further clarity, general sources of uncertainty affecting many dietary exposure assessments should be separated from model-specific uncertainties.

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Oldring PK, O’Mahony C, Dixon J, Vints M, Mehegan J, Dequatre C, Castle L.
Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2014;31(3):444-65. doi: 10.1080/19440049.2013.862348. Epub 2014 Jan 15.
15/01/2014

Development of a new modelling tool (FACET) to assess exposure to chemical migrants from food packaging.

The approach used to obtain European Union-wide data on the usage and concentration of substances in different food packaging materials is described. Statistics were collected on pack sizes and market shares for the different materials used to package different food groups. The packaging materials covered were plastics (both flexible and rigid), metal containers, light metal packaging, paper and board, as well as the adhesives and inks used on them. An explanation as to how these data are linked in various ways in the FACET exposure modelling tool is given as well as an overview of the software along with examples of the intermediate tables of data. The example of bisphenol A (BPA), used in resins that may be incorporated into some coatings for canned foodstuffs, is used to illustrate how the data in FACET are combined to produce concentration distributions. Such concentration distributions are then linked probabilistically to the amounts of each food item consumed, as recorded in national food consumption survey diaries, in order to estimate exposure to packaging migrants. Estimates of exposure are at the level of the individual consumer and thus can be expressed for various percentiles of different populations and subpopulations covered by the national dietary surveys.

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Oldring PK, Castle L, O’Mahony C, Dixon J.
Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2014;31(3):466-89. doi: 10.1080/19440049.2013.860240. Epub 2014 Jan 20
20/01/2014

Estimates of dietary exposure to bisphenol A (BPA) from light metal packaging using food consumption and packaging usage data: a refined deterministic approach and a fully probabilistic (FACET) approach.

Estimates of dietary exposure to bisphenol A (BPA) from light metal packaging using food consumption and packaging usage data: a refined deterministic approach and a fully probabilistic (FACET) approach.

The FACET tool is a probabilistic model to estimate exposure to chemicals in foodstuffs, originating from flavours, additives and food contact materials. This paper demonstrates the use of the FACET tool to estimate exposure to BPA (bisphenol A) from light metal packaging. For exposure to migrants from food packaging, FACET uses industry-supplied data on the occurrence of substances in the packaging, their concentrations and construction of the packaging, which were combined with data from a market research organisation and food consumption data supplied by national database managers. To illustrate the principles, UK packaging data were used together with consumption data from the UK National Diet and Nutrition Survey (NDNS) dietary survey for 19-64 year olds for a refined deterministic verification. The UK data were chosen mainly because the consumption surveys are detailed, data for UK packaging at a detailed level were available and, arguably, the UK population is composed of high consumers of packaged foodstuffs. Exposures were run for each food category that could give rise to BPA from light metal packaging. Consumer loyalty to a particular type of packaging, commonly referred to as packaging loyalty, was set. The BPA extraction levels used for the 15 types of coating chemistries that could release BPA were in the range of 0.00005-0.012 mg dm(-2). The estimates of exposure to BPA using FACET for the total diet were 0.0098 (mean) and 0.0466 (97.5th percentile) mg/person/day, corresponding to 0.00013 (mean) and 0.00059 (97.5th percentile) mg kg(-1) body weight day(-1) for consumers of foods packed in light metal packaging. This is well below the current EFSA (and other recognised bodies) TDI of 0.05 mg kg(-1) body weight day(-1). These probabilistic estimates were compared with estimates using a refined deterministic approach drawing on the same input data. The results from FACET for the mean, 95th and 97.5th percentile exposures to BPA lay between the lowest and the highest estimates from the refined deterministic calculations. Since this should be the case, for a fully probabilistic compared with a deterministic approach, it is concluded that the FACET tool has been verified in this example. A recent EFSA draft opinion on exposure to BPA from different sources showed that canned foods were a major contributor and compared results from various models, including those from FACET. The results from FACET were overall conservative.

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Oldring P. K. T. – Valspar Corporation UK, F. Savrij Droste, R. Whitaker, D. Smith
Jct Coatings Tech 11(1):30-40
01/01/2014

Light Metal Packaging Methodology for Foodstuffs – FACET

Light metal packaging for foodstuffs primarily encompasses cans, closures, and aerosols. For cans used in the European Union (EU), the majority are beverage cans with about 45 billion used per annum (pa) compared to ap-proximately 20 billion food cans pa. Metal closures are subdivided into about 20 billion closures for jars and 80 bil-ion crowns for bottles per year. The ILSI Monograph on Light Metal Packaging for Foodstuffs1 contains background information for the reader unfamiliar with this type of packaging. The FACET project (Flavours, Additives and food Contact materials Exposure Tool) was a four-year project that was partially funded by the European Commission within its Framework FP7 Programme. The project ran from September 2008 until August 2012. FACET was coordinated by University College Dublin and it involved 20 research partners from across Europe, coming from academia, industry, research centers, and small- to medium-sized enterprises. Hearty et al. provided an early overview of the project plan2 and Oldring et al.3,4 offered a view of the part of the project plan that dealt specifically with packaging materials. More recently, the use of FACET for assessing exposure to bisphenol A (BPA) from light metal packaging has been reported.5 As the name indicates, the FACET expo-sure tool provides a single platform with the functionality to estimate consumer exposure to three types of food chemicals, namely chemical food additives (“E-numbers”), chemically defined flavoring substances added to foods, and sub-stances used to make food contact materials. A PC-based desktop application, the FACET exposure tool is publicly avail-able and free of charge. The software tool was developed and populated with data gathered throughout the course of the project, with the facility of uploading any additional data that the end-user might have. This article describes how the information was gathered for the light metal packaging portion of the FACET tool.

FACET Light metal packaging methodology for foodstuffs coatings tech

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Mistura Lorenz, Stefania Sette, Cian O’Mahony, Karl-Heinz Engel, John Mehegan, Catherine Leclercq On behalf of the Flavours, Additives, and Food Contact Material Exposure Task (FACET) Consortium
Food and Chemical Toxicology Volume 58, August 2013, Pages 236-241
01/08/2013

Modelling framework for assessment of dietary exposure to added flavouring substances within the FACET (Flavours, Additives, and Food Contact Material Exposure Task) project.

This paper provides a model to assess dietary exposure to flavouring substances intentionally added to food. The purpose is to describe the approaches currently available and their scientific basis. The proposed exposure model for flavouring substances envisages three different levels of refinement: basic, intermediate and refined. At the two first levels, the model may be applied to all 2543 substances actually in use in Europe, while the refined level has been applied to 41 target flavouring substances selected within the FACET project. The refined level entails the use of the probability of addition of the flavouring substance added to the food and of correction factors related to losses owing to the processing of a food.

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EFSA, EFSA. (2007) Opinion of the Scientific Panel on Plant protection products and their Residues on acute dietary intake assessment of pesticide residues in fruit and vegetables.

Acute dietary intake is one of the factors considered by Member States, the European Commission and international authorities when setting Maximum Residue Leve is (MRL S) for pesticides. The MRL is the maximum concentration of a pesticide residue (expressed as mg/kg that is legally permitted in or on a food or agricultural commodity or animal feedstuff. The measure of acute dietary exposure that is used in MRL-setting is the International Estimate of Short Term Intake (IESTI). The IESTI is calculated using one of 4 standard equations, de pending on the type of commodity involved. An MRL above the limit of detection is set for a Commodity only it is ESI does not exceed the Acute Reference Dose (ARTD) or the pesticide concerned. The re are discussions at international level about whether to change the way that IESTI equations are calculated. Therefore the European Commission asked the EFSA Scientific Panel on Plant protection products and their Residues (PPR Fane) for an opinion on how conservative the ESTI equation is, With respect to the percentage or the total European population protected from intakes above the ARTD, and how much this would be altered by changes to the way the IESTTIs calculated. However, the Panel is aware that risk managers are also interested in the special case of people who consume a commodity containing residues at the MRL. Therefore the Panel undertook two types of assessment: “total population assessments”, estimating the level of protection for the total population based on the levels of pesticides observed in monitoring programs, and “MRL-level assessments” for the special case of people who consume one commodity containing residues at the MRL and other commodities at monitoring levels. The Panel estimated acute dietary intakes by probabilistic mode ling This used dat a on food consumption and body we ight from national surveys, and took account of unit-to-unit variability of residues using variability factors. The probabilistic estimates of intakes were higher than measured intakes from a duplicate diet study, suggesting the Paneľ’s results are conservative .e. overestimating intakes and underestimating levels of protection. However, this comparison was possible for only 6 pesticides in one country and one age group, and extrapolation to others countries and age groups is uncertain. It was not possible to conduct probabilistic modelling for the entire population of the Eu, or for all pesticides. The Panel conducte  total population assessments for a number of scenarios representing different combinations of 13 pesticides, 8 countries and a range of age groups from babies to seniors. For practical reasons, the MRL-level assessments were base d on a reduce d range or scenarios, representing only two countries (Germany and The Netherlands) and 11 pesticides. For the total population, the Paneľ’s estimates suggested that the level of protection (LoP) provided by the IESTI equation as currently used in the EU (including variability factors of 5 & 7) varies quite widely between different countries, age groups and pesticides. For some pesticide/country/age group scenarios the estimated LoP was between 99 and 99.9%, i.e.

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Safford B & A.M.Api, C.Barratt, D.Comiskey, G.Ellis, C.McNamara, C.O’Mahony, S.Robison, J.Rose, B.Smith, S.Tozeri
Regulatory Toxicology and Pharmacology Volume 86, June 2017, Pages 148-156
28/02/2017

Application of the expanded Creme RIFM consumer exposure model to fragrance ingredients in cosmetic, personal care and air care products

As part of a joint project between the Research Institute for Fragrance Materials (RIFM) and Creme Global, a Monte Carlo model (here named the Creme RIFM model) has been developed to estimate consumer exposure to ingredients in personal care products. Details of the model produced in Phase 1 of the project have already been published. Further data on habits and practises have been collected which enable the model to estimate consumer exposure from dermal, oral and inhalation routes for 25 product types. . In addition, more accurate concentration data have been obtained which allow levels of fragrance ingredients in these product types to be modelled. Described is the use of this expanded model to estimate aggregate systemic exposure for eight fragrance ingredients. Results are shown for simulated systemic exposure (expressed as μg/kg bw/day) for each fragrance ingredient in each product type, along with simulated aggregate exposure. Highest fragrance exposure generally occurred from use of body lotions, body sprays and hydroalcoholic products. For the fragrances investigated, aggregate exposure calculated using this model was 11.5–25 fold lower than that calculated using deterministic methodology. The Creme RIFM model offers a very comprehensive and powerful tool for estimating aggregate exposure to fragrance ingredients.

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Comiskey D., Api AM2, Barratt C3, Daly EJ1, Ellis G4, McNamara C1, O’Mahony C1, Robison SH5, Safford B6, Smith B7, Tozer S8.
Regul Toxicol Pharmacol. 2015 Aug;72(3):660-72. doi: 10.1016/j.yrtph.2015.05.012. Epub 2015 May 19
19/05/2015

Novel database for exposure to fragrance ingredients in cosmetics and personal care products.

Exposure of fragrance ingredients in cosmetics and personal care products to the population can be determined by way of a detailed and robust survey. The frequency and combinations of products used at specific times during the day will allow the estimation of aggregate exposure for an individual consumer, and to the sample population. In the present study, habits and practices of personal care and cosmetic products have been obtained from market research data for 36,446 subjects across European countries and the United States in order to determine the exposure to fragrance ingredients. Each subject logged their product uses, time of day and body application sites in an online diary for seven consecutive days. The survey data did not contain information on the amount of product used per occasion or body measurements, such as weight and skin surface area. Nevertheless, this was found from the literature where the likely amount of product used per occasion or body measurement could be probabilistically chosen from distributions of data based on subject demographics. The daily aggregate applied consumer product exposure was estimated based on each subject’s frequency of product use, and Monte Carlo simulations of their likely product amount per use and body measurements. Statistical analyses of the habits and practices and consumer product exposure are presented, which show the robustness of the data and the ability to estimate aggregate consumer product exposure. Consequently, the data and modelling methods presented show potential as a means of performing ingredient safety assessments for personal care and cosmetics products.

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Safford B., A.M.Api, C.Barratt, D.Comiskey, G.Ellis, E.J. Daly, C.McNamara, C.O’Mahony, S.Robison, B.Smith, S.Tozeri
Regulatory Toxicology and Pharmacology Volume 72, Issue 3, August 2015, Pages 673-682
01/08/2015

Use of an aggregate exposure model to estimate consumer exposure to fragrance ingredients in personal care and cosmetic products.

Background:
Ensuring the toxicological safety of fragrance ingredients used in personal care and cosmetic products is essential in product development and design, as well as in the regulatory compliance of the products. This requires an accurate estimation of consumer exposure which, in turn, requires an understanding of consumer habits and use of products. Where ingredients are used in multiple product types, it is important to take account of aggregate exposure in consumers using these products. This publication investigates the use of a newly developed probabilistic model, the Creme RIFM model, to estimate aggregate exposure to fragrance ingredients using the example of 2-phenylethanol (PEA). The output shown demonstrates the utility of the model in determining systemic and dermal exposure to fragrances from individual products, and aggregate exposure. The model provides valuable information not only for risk assessment, but also for risk management. It should be noted that data on the concentrations of PEA in products used in this article were obtained from limited sources and not the standard, industry wide surveys typically employed by the fragrance industry and are thus presented here to illustrate the output and utility of the newly developed model. They should not be considered an accurate representation of actual exposure to PEA.
Methods:

Determination of aggregate exposure to a number of fragrance ingredients was conducted using a model developed by Creme Global in conjunction with RIFM (described here as the Creme RIFM model). Full details of the model are given in a concurrent publication (Comiskey et al., 2015).

The model uses probabilistic (Monte Carlo) simulation to allow sampling from distributions of data sets providing a more realistic estimate of aggregate exposure to individuals across a population. The Creme RIFM

Results:

The results for both applied product exposure and fragrance ingredient exposure are reported below. It should be noted that the applied product amount refers to the amount of product that is retained on the skin after application, taking into account the product retention factors. This product retention factor also helps define exposure to the individual fragrance ingredients.

The applied product and fragrance ingredient exposures are presented in the form of box-and-whisker plots which shows

Conclusions:
The dietary feedback system was used to deliver personalized dietary advice within a multi-country study. Overall, there was good agreement between the manual and automated feedback systems, giving promise to the use of automated systems for personalizing dietary advice.

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Hall B, Steiling W, Safford B, Coroama M, Tozer S, Firmani C, McNamara C, Gibney M.
Food Chem Toxicol. 2011 Feb;49(2):408-22. doi: 10.1016/j.fct.2010.11.016. Epub 2010 Nov 18.
18/11/2010

European consumer exposure to cosmetic products, a framework for conducting population exposure assessments Part 2.

Access to reliable exposure data is essential for the evaluation of the toxicological safety of ingredients in cosmetic products. This study complements the data set obtained previously (Part 1) and published in 2007 by the European cosmetic industry acting within COLIPA. It provides, in distribution form, exposure data on daily quantities of five cosmetic product types: hair styling, hand cream, liquid foundation, mouthwash and shower gel. In total 80,000 households and 14,413 individual consumers in five European countries provided information using their own products. The raw data were analysed using Monte Carlo simulation and a European Statistical Population Model of exposure was constructed. A significant finding was an inverse correlation between the frequency of product use and the quantity used per application recorded for mouthwash and shower gel. The combined results of Part 1 (7 product types) and Part 2 (5 products) reported here, bring up to date and largely confirm the current exposure parameters concerning some 95% of the estimated daily exposure to cosmetics use in the EU. The design of this study, with its relation to demographic and individual diversity, could serve as a model for studies of populations’ exposure to other consumer products.

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McNamara C, Rohan D, Golden D, Gibney M, Hall B, Tozer S, Safford B, Coroama M, Leneveu-Duchemin MC, Steiling W.
Food Chem Toxicol. 2007 Nov;45(11):2086-96. Epub 2007 Jul 7.
07/07/2007

Probabilistic modelling of European consumer exposure to cosmetic products.

In this study, we describe the statistical analysis of the usage profile of the European population to seven cosmetic products. The aim of the study was to construct a reliable model of exposure of the European population from use of the selected products: body lotion, shampoo, deodorant spray, deodorant non-spray, facial moisturiser, lipstick and toothpaste. The first step in this process was to gather reliable data on consumer usage patterns of the products. These data were sourced from a combination of market information databases and a controlled product use study by the trade association Colipa. The market information study contained a large number of subjects, in total 44,100 households and 18,057 habitual users (males and females) of the studied products, in five European countries. The data sets were then combined to generate a realistic distribution of frequency of use of each product, combined with distribution of the amount of product used at each occasion using the CREMe software. A Monte Carlo method was used to combine the data sets. This resulted in a new model of European exposure to cosmetic products being constructed.

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Hall B, Tozer S, Safford B, Coroama M, Steiling W, Leneveu-Duchemin MC, McNamara C, Gibney M.
Food Chem Toxicol. 2007 Nov;45(11):2097-108. Epub 2007 Jun 16.
16/06/2007

European consumer exposure to cosmetic products, a framework for conducting population exposure assessments.

Access to reliable exposure data is essential to evaluate the toxicological safety of ingredients in cosmetic products. This study was carried out by European cosmetic manufacturers acting within the trade association Colipa, with the aim to construct a probabilistic European population model of exposure. The study updates, in distribution form, the current exposure data on daily quantities of six cosmetic products. Data were collected using a combination of market information databases and a controlled product use study. In total 44,100 households and 18,057 individual consumers in five European countries provided data using their own products. All product use occasions were recorded, including those outside of home. The raw data were analysed using Monte Carlo simulation and a European Statistical Population Model of exposure was constructed. A significant finding was an inverse correlation between frequency of product use and quantity used per application for body lotion, facial moisturiser, toothpaste and shampoo. Thus it is not appropriate to calculate daily exposure to these products by multiplying the maximum frequency value by the maximum quantity per event value. The results largely confirm the exposure parameters currently used by the cosmetic industry. Design of this study could serve as a model for future assessments of population exposure to chemicals in products other than cosmetics.

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Tozer S, Kelly S, O’Mahony C, Daly EJ, Nash JF.
Food Chem Toxicol. 2015 Sep;83:103-10. doi: 10.1016/j.fct.2015.06.005. Epub 2015 Jun 16
16/06/2015

Aggregate exposure modelling of zinc pyrithione in rinse-off personal cleansing products using a person-orientated approach with market share refinement.

Realistic estimates of chemical aggregate exposure are needed to ensure consumer safety. As exposure estimates are a critical part of the equation used to calculate acceptable “safe levels” and conduct quantitative risk assessments, methods are needed to produce realistic exposure estimations. To this end, a probabilistic aggregate exposure model was developed to estimate consumer exposure from several rinse off personal cleansing products containing the anti-dandruff preservative zinc pyrithione. The model incorporates large habits and practices surveys, containing data on frequency of use, amount applied, co-use along with market share, and combines these data at the level of the individual based on subject demographics to better estimate exposure. The daily-applied exposure (i.e., amount applied to the skin) was 3.79 mg/kg/day for the 95th percentile consumer. The estimated internal dose for the 95th percentile exposure ranged from 0.01-1.29 μg/kg/day after accounting for retention following rinsing and dermal penetration of ZnPt. This probabilistic aggregate exposure model can be used in the human safety assessment of ingredients in multiple rinse-off technologies (e.g., shampoo, bar soap, body wash, and liquid hand soap). In addition, this model may be used in other situations where refined exposure assessment is required to support a chemical risk assessment.

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Ross John; Driver, Jeffrey; Lunchick, Curt; O’Mahony, Cian
Outlooks on Pest Management, Volume 26, Number 1, February 2015, pp. 33-37(5)
01/02/2015

Models for estimating human exposure to pesticides, Outlooks on Pest Management

Any quantitative understanding of human risk from exposure to pesticides requires knowledge of both hazard (the intrinsic ability of a pesticide to cause harm) and exposure (absorbed dose), i.e., risk is directly proportional to the product of hazard and exposure. Thus, regardless of potential high hazard, risk may be insignificant if exposure is very low, and exposure-driven risk assessment is increasingly being recognized as being the best path forward for the protection of human health. In fact, regulatory agencies did not start doing quantitative risk assessments for pesticides using endpoints other than lethality until the 1970s in part because the analytical tools to sensitively measure exposure were lacking. Quantifying exposure to pesticides required analytical methods such as gas chromatography and liquid chromatography that weren?t commercially available until the mid-1960s to early 1970s, respectively. With the advent of quadrapole mass spectroscopy in the early 1970s the ability to quantify sub milligram per kilogram bodyweight exposures to a wide variety of pesticides with confidence became commonplace. Analytical capability has continued to improve, and it is now possible to measure exposures in the nanogram and sometimes pictogram per kilogram range. As our quantitative knowledge of human exposure matured, it was desirable to extrapolate the knowledge from one chemical that had been measured to others that had not. Indeed, by the early 1980s it became evident that handler exposure to conventional pesticides was generic and not chemical specific. Part of the driving factor to do this modeling was that definitive exposure measurements for one chemical under one set of conditions was costly (>?100,000) and time consuming (months), and the combinations and permutations of exposure scenarios and pesticides are staggering. Models allow us to estimate the exposure to a new active substance or rank exposure of one pesticide to others used in similar conditions. The objective of this paper is to present a brief overview of the range of human exposure models that are available, and the route or pathway of exposure for which they estimate dose with the hope that it provides an appreciation of the basic approaches, chronology and effort expended in developing them.

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O’Sullivan AJ, S Pigat, C O’Mahony, MJ Gibney, AI McKevitt
Food Additives & Contaminants: Part A 34 (11), 1863-1874
23/08/2017

Longitudinal modelling of the exposure of young UK patients with PKU to acesulfame K and sucralose

Artificial sweeteners are used in protein substitutes intended for the dietary management of inborn errors of metabolism (phenylketonuria, PKU) to improve the variety of medical foods available to patients and ensure dietary adherence to the prescribed course of dietary management. These patients can be exposed to artificial sweeteners from the combination of free and prescribed foods. Young children have a higher risk of exceeding acceptable daily intakes (ADI) for additives than adults, due to higher food intakes per kg body weight. Young patients with PKU aged 1–3 years can be exposed to higher levels of artificial sweeteners from these dual sources than normal healthy children and are at a higher risk of exceeding the ADI. Standard intake assessment methods are not adequate to assess the additive exposure of young patients with PKU. The aim of this study was to estimate the combination effect on the intake of artificial sweeteners and the impact of the introduction of new provisions for an artificial sweetener (sucralose, E955) on exposure of PKU patients using a validated probabilistic model. Food consumption data were derived from the food consumption survey data of healthy young children in the United Kingdom from the National Diet and Nutrition Survey (NDNS, 1992–2012). Specially formulated protein substitutes as foods for special medical purposes (FSMPs) were included in the exposure model to replace restricted foods. Inclusion of these protein substitutes is based on recommendations to ensure adequate protein intake in these patients. Exposure assessment results indicated the availability of sucralose for use in FSMPs for PKU leads to changes in intakes in young patients. These data further support the viability of probabilistic modelling as a means to estimate food additive exposure in patients consuming medical nutrition products.

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Pigat Sandrine, Rosalyn O’Connor
The FASEB Journal 29 (1_supplement), 905.3
01/04/2015

Probabilistic Bioactive Food Compound Intakes in the European BACCHUS Project

Objective

The EU funded BACCHUS project aims to develop tools and resources to study relationships between bioactive food compound intakes and cardiovascular health in humans. To handle variation and uncertainty of bioactive levels in foods a probabilistic model of bioactive intakes was used to estimate distributions of population intakes.

Methods

To assess food bioactive intake distributions in Europe, national food intake surveys were used from the UK, the Netherlands, Norway and Spain. To account for variability and uncertainty of bioactive concentrations within foods, the foods consumed were linked to discrete bioactive concentration distributions using published data on plant based foods as captured in the eBasis database. Daily bioactive population intakes were calculated using a probabilistic intake model in the Creme Nutrition® software.

Results

Data shows apple (g/day) and catechin (mg/day) intakes from apples and apple products in the four countries.

Daily intakes (mg/day) Ireland UK Spain Norway
Mean (95%ile) Mean (95%ile) Mean (95%ile) Mean (95%ile)
Apple + Apple Products 33 (135) 32 (129) 42 (183) 78 (300)
Catechin 1±0.1 (5.8±0.4) 1±0.1 (5.2±0.3) 1.3±0.06 (8±0.4) 2.5±0.14 (14.8±1.0)
Epicatechin 13±0.6 (56.5±3.5) 12.9±0.65 (54.5±3.6) 16.7±0.48 (73.1±2.4) 29.8±1.06 (119.6±6.0)
Epigallocatechin 22.4±0.9 (92.2±4.1) 21.7±1.0 (88.2±4.9) 28.9±0.8 (125.2±6.8) 53.1±1.8 (204.9±7.7)
Epicatechin-gallate 0.1±0.0 (0.3±0.0) 0.1±0.0 (0.2±0.0) 0.1±0.0 (0.3±0.0) 0.1±0.0 (0.6±0.0)
Conclusion

This study enables the link between bioactive concentration levels in foods and representative population intakes, using probabilistic intake models to better estimate full intake distributions in a population.

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O’Mahony C. et al on behalf of the ECETOC Task Force on guidance for effective use of human exposure data in risk assessment of chemicals
ECETOC Technical Report no.126Affiliation: European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), November 2016
01/11/2016

ECETOC Technical Report no.126: Guidance for effective use of human exposure data in risk assessment of chemicals

This report details much of the current state-of-the-art of consumer exposure assessment data and models that can be used in chemical risk assessment, with a particular focus upon aggregate exposure assessment. Aggregate exposure considers all sources of exposure to a single chemical (e.g. hair care products, cosmetics, detergents, foods, environmental media, etc.) via all routes (oral, dermal, and inhalation). The report focuses on consumer products (not including the assessment of occupational exposure), considering the following product domains: cosmetics and personal care products, household products, food and other consumer products (such as surface coatings, adhesives, sealants, disinfectants, automotive care products, toys etc.). Exposure assessment is, by necessity, an iterative process. If, in any tier, negligible or acceptable risk cannot be demonstrated, the assessment moves to a higher tier. The risk assessment is finished if (in any tier of the approach) it has been demonstrated that the risk for the population under consideration is negligible or acceptable, or if in the highest tier the risk is not acceptable and further refinements are not possible. This approach was proposed in the WHO/IPCS framework for risk assessment of combined exposure to multiple chemicals (Meek et al, 2011). The report is divided into four sections. Section One gives background on the tiered approach to exposure assessment, including aggregate exposure assessment in the consumer product domains. Section Two provides an overview of the current exposure landscape, detailing the main data sources, models and tools that are available for chemical risk assessment in the food, cosmetics, household, and consumer products domains. Conclusions and recommendations on current opportunities for the development and provision of new tools and data are also presented based on the outcome of this landscaping exercise. This section is accompanied by a detailed spreadsheet referencing all identified data sources and tools identified for chemical exposure assessment. Section Three presents examples of case studies of aggregate exposure to the chemicals triclosan and phenoxyethanol (PhE), outlining how current models and data can be best used for higher-tier exposure assessments. In addition, there is a literature review of the broader domain of aggregate exposure assessment, detailing other examples and approaches that exist for aggregate exposure assessment. Section Four contains discussion and conclusions on areas of opportunity for exposure science over the next two to five years. The key conclusions of this report are summarised as follows: • Exposure assessments should involve an iterative process, and should be conducted using a tiered strategy, where the lowest tier (0) involves a semi-quantitative assessment of the all sources, pathways and routes contributing to aggregate exposure to a substance, the mid-tier (1) tends to be a deterministic estimate with conservative assumptions, the higher tier (2) is a more realistic estimation of population exposure with increased use of measured data using probabilistic methods, and at the highest tier (3) exposure is modelled with a person-orientated approach using raw data sets. • Many tools and databases exist to support consumer exposure assessment, as demonstrated in the landscaping effort. Users can select the data and tools that best fit their specific situation and level of assessment. • Most consumer exposures tools are designed to evaluate single substance, single use assessments. • Higher tier exposure assessments require more realistic and representative data to the situation being assessed and additional understanding of data correlations. • Subject oriented aggregate tools (PACEM, Creme Care & Cosmetics) are available that allow aggregate exposure assessment within some consumer product domains. For example, in cosmetics and personal care products, the availability of robust tools and data sets (habits and practices data with product co-use, and the use of presence probabilities) allow refined estimates of aggregate exposure. • A major challenge in estimating aggregate exposure in many product categories is obtaining representative information on exposure factors (Habits and Practices Data, Co-use Data, Chemical Concentration Data and Chemical Occurrence Data), as well as potential correlations between these factors. For some domains, such as household care products, the available data are limited. • Guidance should be developed to indicate when higher tier aggregate assessments might be a priority. Considerations include relative contributions of different sources, level of conservatism in a screening single source assessment (for example, the case study indicates a higher tier aggregate assessment may produce a lower exposure estimate than the maximum screening exposure predicted for a single uses), and total exposure levels from representative biomonitoring studies. • Model verification with real-life data (e.g. biomonitoring) on a representative range of chemicals would assist to promote use/acceptance of exposure model predictions. Wider engagement of industry, the public and regulators into the generation, harmonisation and management of input data related to consumer exposure will foster the advances in aggregate exposure modelling, especially in domains where currently little data are available.

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Comiskey Damien & Cian O’Mahony, E.J. Daly, Cronan McNamara
Toxicology Letters, Volume 229, Supplement, 10 September 2014, Page S111
10/09/2014

Combining databases to estimate population exposure to cosmetics and personal care products

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Hall Barbara, Sarah Tozer, Bob Safford, Manuela Coroama, Winfried Steiling, Marie-Cristine Leneveu-Duchemin, Cronan McNamara, Michael Gibney
Toxicology Letters, Volume 172, Supplement, 7 October 2007, Page S12
05/09/2007

Exposure to cosmetic products in Europe

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Tozer Sarah, J F Nash, and E.J. Daly
International Society for Environmental Epidemiology (ISEE) Annual Meeting, Abstract Number:4967, September 2013
01/09/2013

Probabilistic Aggregate Exposure Modelling for a Broad Spectrum Antimicrobial in Personal Cleansing Products

Background:

Realistic estimates of chemical aggregate exposure are needed to ensure consumer safety and satisfy the requirements of regulators. In most cases, aggregate exposure is estimated simply by adding deterministic exposures from all product types containing the chemical. However, this summation will result in an unrealistically-conservative estimate since individuals vary in their patterns of product use, and it is very unlikely that consumers use high levels of all products at the same time. As aggregate exposure estimates could be used to calculate acceptable “safe levels” and conduct risk assessments for chemicals, methods are needed to produce realistic exposure estimations.

Methods:

A probabilistic aggregate exposure model was developed to estimate consumer exposure in Europe and North America to a hypothetical broad spectrum biocide, from a range of rinse off personal cleansing products. It incorporates large habits and practices surveys, from industry/cosmetic trade associations, containing data on frequency of use, amount, co-use along with market share, and combines these data at the level of the individual based on subject demographics (gender, age, ethnicity) to realistically calculate exposure. Results: When the antimicrobial was assumed present in five rinse off products (Shampoo: 2% and other products: 0.5%), the average daily applied exposure (amount applied to the skin) was estimated at 1.65 mg/kg/day for the average person and 3.79 mg/kg/day for the 95th percentile consumer. This probabilistic modelling offers significant exposure refinement versus deterministic aggregate summation methods.

Conclusions:

This probabilistic aggregate exposure model provides robust data that can be used in the human safety assessment of multiple rinse-off technologies (e.g., shampoo, bar soap, body wash, liquid hand soap) containing the biocide. In addition, this model may be used in other situations where refined exposure assessment is required to support a chemical risk assessment.

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Tozer Sarah, Cian O’Mahony, Jay Nash, Seamus Kelly, E.J. Daly
Toxicology Letters, Volume 229, Supplement, 10 September 2014, Page S128
10/09/2014

Probabilistic aggregate exposure modelling to aluminium from the diet, cosmetics and medicines

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LaKind Judy S. & Carol J. Burns, Daniel Q. Naiman, Cian O’Mahony, Giulia Vilone, Annette J. Burns & Joshua S. Naiman
Journal of Toxicology and Environmental Health, Part B Critical Reviews Volume 20, 2017 – Issue 8
20/11/2017

Critical and systematic evaluation of data for estimating human exposures to 2,4-dichlorophenoxyacetic acid (2,4-D) – quality and generalizability

The herbicide 2,4-dichlorophenoxyacetic acid (2,4-D) has been commercially available since the 1940’s. Despite decades of data on 2,4-D in food, air, soil, and water, as well as in humans, the quality the quality of these data has not been comprehensively evaluated. Using selected elements of the Biomonitoring, Environmental Epidemiology, and Short-lived Chemicals (BEES-C) instrument (temporal variability, avoidance of sample contamination, analyte stability, and urinary methods of matrix adjustment), the quality of 156 publications of environmental- and biomonitoring-based 2,4-D data was examined. Few publications documented steps were taken to avoid sample contamination. Similarly, most studies did not demonstrate the stability of the analyte from sample collection to analysis. Less than half of the biomonitoring publications reported both creatinine-adjusted and unadjusted urine concentrations. The scope and detail of data needed to assess temporal variability and sources of 2,4-D varied widely across the reviewed studies. Exposures to short-lived chemicals such as 2,4-D are impacted by numerous and changing external factors including application practices and formulations. At a minimum, greater transparency in reporting of quality control measures is needed. Perhaps the greatest challenge for the exposure community is the ability to reach consensus on how to address problems specific to short-lived chemical exposures in observational epidemiology investigations. More extensive conversations are needed to advance our understanding of human exposures and enable interpretation of these data to catch up to analytical capabilities. The problems defined in this review remain exquisitely difficult to address for chemicals like 2,4-D, with short and variable environmental and physiological half-lives and with exposures impacted by numerous and changing external factors.

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van der Fels-Klerx, H.J. (Ine) & Simon G. Edwards, Marc C. Kennedy, Sue O’Hagan, Cian O’Mahony, Gabriele Scholz, Pablo Steinberg, Alessandro Chiodini
Food and Chemical Toxicology Volume 74, December 2014, Pages 360-371
01/12/2014

A framework to determine the effectiveness of dietary exposure mitigation to chemical contaminants

In order to ensure the food safety, risk managers may implement measures to reduce human exposure to contaminants via food consumption. The evaluation of the effect of a measure is often an overlooked step in risk analysis process. The aim of this study was to develop a systematic approach for determining the effectiveness of mitigation measures to reduce dietary exposure to chemical contaminants. Based on expert opinion, a general framework for evaluation of the effectiveness of measures to reduce human exposure to food contaminants was developed. The general outline was refined by application to three different cases: 1) methyl mercury in fish and fish products, 2) deoxynivalenol in cereal grains, and 3) furan in heated products. It was found that many uncertainties and natural variations exist, which make it difficult to assess the impact of the mitigation measure. Whenever possible, quantitative methods should be used to describe the current variation and uncertainty. Additional data should be collected to cover natural variability and reduce uncertainty. For the time being, it is always better for the risk manager to have access to all available information, including an assessment of uncertainty; however, the proposed methodology provides a conceptual framework for addressing these systematically.

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Tozer S, Kosemund K, Kelly S, O’Mahony C.
Toxicology Letters, Volume 238, Issue 2, Supplement, 16 October 2015, Page S368
16/10/2015

Aggregate exposure to vitamin A from cosmetics and the diet

Realism is important in estimating consumer exposure to a substance, especially when accounting for exposure from multiple sources. Humans are exposed to vitamin A from food, dietary supplements and cosmetics products. A probabilistic aggregate exposure model was developed for estimating exposure distributions to vitamin A (as retinol equivalents) in pre-/post-menopausal, and menopausal women in European and US populations. Data from large dietary surveys were used, together with realistic and extreme case scenarios of cosmetics product use (including occurrence data for vitamin A presence in 17 cosmetic products). Results of absorbed exposure estimates were expressed as μg/kg bw/day by incorporating dermal and oral bioavailability data. The mean and 95th percentile (P95) aggregate exposures were below the EU Tolerable Upper Intake Limit (3000 μg/day; 45 μg/kg/day internal exposure dose (IED)), providing positive assurances of safety. The major source of vitamin A exposure is the diet, with cosmetics providing only a small fraction of total exposure (2-5% at P95). In addition to providing a realistic assessment of total vitamin A exposure, this work provides a case study on how to approach future complex aggregate exposure questions.

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Aylward Lesa, Giulia Vilone, Christina Cowan-Ellsberry, Jon A. Arnot, John N. Westgate, Cian O’Mahony & Sean M. Hays
Journal of Exposure Science and Environmental Epidemiology 30 (Suppl 4)
05/12/2018

Exposure to selected preservatives in personal care products: case study comparison of exposure models and observational biomonitoring data

Exposure models provide critical information for risk assessment of personal care product ingredients, but there have been limited opportunities to compare exposure model predictions to observational exposure data. Urinary excretion data from a biomonitoring study in eight individuals were used to estimate minimum absorbed doses for triclosan and methyl-, ethyl-, and n-propyl- parabens (TCS, MP, EP, PP). Three screening exposure models (European Commission Scientific Commission on Consumer Safety [SCCS] algorithms, ConsExpo in deterministic mode, and RAIDAR-ICE) and two higher-tier probabilistic models (SHEDS-HT, and Creme Care & Cosmetics) were used to model participant exposures. Average urinary excretion rates of TCS, MP, EP, and PP for participants using products with those ingredients were 16.9, 3.32, 1.9, and 0.91 μg/kg-d, respectively. The SCCS default aggregate and RAIDAR-ICE screening models generally resulted in the highest predictions compared to other models. Approximately 60–90% of the model predictions for most of the models were within a factor of 10 of the observed exposures; ~30–40% of the predictions were within a factor of 3. Estimated exposures from urinary data tended to fall in the upper range of predictions from the probabilistic models. This analysis indicates that currently available exposure models provide estimates that are generally realistic. Uncertainties in preservative product concentrations and dermal absorption parameters as well as degree of metabolism following dermal absorption influence interpretation of the modeled vs. measured exposures. Use of multiple models may help characterize potential exposures more fully than reliance on a single model.

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Oldring P. K. T., C. O’Mahony et al
January 2014 Jct Coatings Tech 11(1):30-40
03/01/2014

FACET: Light metal packaging methodology

Agency Light metal packaging for food stuffs primarily encompasses cans, closures and aerosols. For cans used in the European Union (EU), the majority are beverage cans with about 45 billion used per annum (pa) compared to approximately 20 billion food cans. Metal closures are subdivided into about 20 billion closures for jars and 80 billion crowns for bottles per year. The ILSI Monograph on Light Metal Packaging for Food stuffs ( contains background information for the reader unfamiliar with this type of packaging. The FACET project (Flavours, Additives and food Contact materials Exposure Tool) was a four-year project that was partially funded by the European Commission within its Framework FP7 Programme. The project ran from September 2008 until August 2012. FACET was coordinated by University College Dublin and it involved 20 research partners from across Europe, coming from academia, industry, research centers, and small- to medium-sized enterprises. Hearty et al. provided an early overview of the project plan and Oldring et al.3,4 offered a view of the part of the project plan that dealt specifically with packaging materials. More recently, the use of FACET for assessing exposure to bisphenol A (BPA) from light metal packaging has been reported.5As the name indicates, the FACET expo-sure tool provides a single platform with the functionality to estimate consumer exposure to three types of food chemicals, namely chemical food additives(“E-numbers”), chemically defined flavor-ing substances added to foods, and sub-stances used to make food contact materials. A PC-based desktop application, the FACET exposure tool is publicly avail-able and free of charge. The software tool was developed and populated with data gathered throughout the course of the project, with the facility of uploading any additional data that the end-user might have. This article describes how the information was gathered for the light metal packaging portion of the FACET tool.

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O’Sullivan Aaron J., Sandrine Pigat, Cian O’Mahony, Michael J. Gibney & Aideen I. McKevitt
Food Additives & Contaminants: Part A Volume 35, 2018 – Issue 1
17/11/2017

Predictive modelling of the exposure to Steviol Glycosides in Irish patients aged 1-3 years with Phenylketonuria and Cow’s milk protein allergy

Children with Phenylketonuria (PKU) and severe cow’s milk protein allergy (CMPA) consume prescribed, specially formulated, foods for special medical purposes (FSMPs) as well as restricted amounts of normal foods. These patients are exposed to artificial sweeteners from the consumption of a combination of free and prescribed foods. Young patients with PKU and CMPA have a higher risk of exceeding acceptable daily intakes (ADI) for additives than age-matched healthy children. A predictive modelling approach has been adapted successfully to assess the additive exposure of young patients with PKU and CMPA to artificial sweeteners. Steviol glycosides (E960) are at various stages of regulatory approval for the various food categories in the EU but are not as yet permitted for use in products intended for young children. The aim of this study was to predict potential steviol glycoside exposure in young children with PKU and CMPA considering the potential for future provisions for the use of this sweetener. The recent introduction of steviol glycosides means that no exposure data are available for children with CMPA and PKU. Food consumption data were derived from the food consumption survey data of healthy young children in Ireland from the National Preschool and Nutrition Survey (NPNS, 2010–11). Specially formulated amino acid-based FSMPs are used to replace whole or milk protein foods and were included in the exposure model to replace restricted foods. The recommendations to ensure adequate protein intake in these patients were used to determine FSMP intake. Exposure assessment results indicated that the maximum permitted level (MPL) for FSMPs would warrant careful consideration to avoid exposures above the ADI. These data can be used to inform recommendations for the medical nutrition industry.

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O’Sullivan Aaron J., Sandrine Pigat, Cian O’Mahony, Michael J. Gibney & Aideen I. McKevitt
Pages 1660-1671 | Received 11 May 2016, Accepted 08 Aug 2016, Accepted author version posted online: 09 Sep 2016, Published online: 30 Sep 2016
09/09/2016

Probabilistic modelling to assess exposure to three artificial sweeteners of young Irish patients aged 1–3 years with PKU and CMPA

The choice of suitable normal foods is limited for individuals with particular medical conditions, e.g., inborn errors of metabolism (phenylketonuria – PKU) or severe cow’s milk protein allergy (CMPA). Patients may have dietary restrictions and exclusive or partial replacement of specific food groups with specially formulated products to meet particular nutrition requirements. Artificial sweeteners are used to improve the appearance and palatability of such food products to avoid food refusal and ensure dietary adherence. Young children have a higher risk of exceeding acceptable daily intakes for additives than adults due to higher food intakes kg–1 body weight. The Budget Method and EFSA’s Food Additives Intake Model (FAIM) are not equipped to assess partial dietary replacement with special formulations as they are built on data from dietary surveys of consumers without special medical requirements impacting the diet. The aim of this study was to explore dietary exposure modelling as a means of estimating the intake of artificial sweeteners by young PKU and CMPA patients aged 1–3 years. An adapted validated probabilistic model (FACET) was used to assess patients’ exposure to artificial sweeteners. Food consumption data were derived from the food consumption survey data of healthy young children in Ireland from the National Preschool and Nutrition Survey (NPNS, 2010–11). Specially formulated foods for special medical purposes were included in the exposure model to replace restricted foods. Inclusion was based on recommendations for adequate protein intake and dietary adherence data. Exposure assessment results indicated that young children with PKU and CMPA have higher relative average intakes of artificial sweeteners than healthy young children. The reliability and robustness of the model in the estimation of patient additive exposures was further investigated and provides the first exposure estimates for these special populations.

Food Additives and Contaminants journal software for modelling dietary exposure to food chemicals and nutrients

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Design, development and validation of software for modelling dietary exposure to food chemicals and nutrients.

The Monte Carlo computational system for stochastic modelling of dietary exposure to food chemicals and nutrients is presented. This system was developed through a European Commission-funded research project. It is accessible as a Web-based application service. The system allows and supports very significant complexity in the data sets used as the model input, but provides a simple, general purpose, linear kernel for model evaluation. Specific features of the system include the ability to enter (arbitrarily) complex mathematical or probabilistic expressions at each and every input data field, automatic bootstrapping on subjects and on subject food intake diaries, and custom kernels to apply brand information such as market share and loyalty to the calculation of food and chemical intake.

Food Additives and Contaminants journal software for modelling dietary exposure to food chemicals and nutrients

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McNamara C, Mehegan J, O’Mahony C, Safford B, Smith B, Tennant D, Buck N, Ehrlich V, Sardi M, Haldemann Y, Nordmann H, Jasti PR.
Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2011 Dec;28(12):1636-44. doi: 10.1080/19440049.2011.606232. Epub 2011 Oct 13.
04/10/2013

Uncertainty analysis of the use of a retailer fidelity card scheme in the assessment of food additive intake.

Background:

The feasibility of using a retailer fidelity card scheme to estimate food additive intake was investigated in an earlier study. Fidelity card survey information was combined with information provided by the retailer on levels of the food colour Sunset Yellow (E110) in the foods to estimate a daily exposure to the additive in the Swiss population. As with any dietary exposure method the fidelity card scheme is subject to uncertainties and in this paper the impact of uncertainties associated with input variables including the amounts of food purchased, the levels of E110 in food, the proportion of food purchased at the retailer, the rate of fidelity card usage, the proportion of foods consumed outside of the home and bodyweights and with systematic uncertainties was assessed using a qualitative, deterministic and probabilistic approach. An analysis of the sensitivity of the results to each of the probabilistic inputs was also undertaken. The analysis identified the key factors responsible for uncertainty within the model and demonstrated how the application of some simple probabilistic approaches can be used quantitatively to assess uncertainty.

 

Food Additives and Contaminants journal software for modelling dietary exposure to food chemicals and nutrients

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