食用香料风险评估方法与应用

食用香料的风险评估方法与其他食品添加剂相比有一定的特殊性,毒理学关注阈值法是香料评估的主要方法。应用毒理学关注阈值法进行香料评估时,同样要求对人类的暴露水平进行正确估计,目前常用的香料暴露评估方法有源自调查的最大摄入量法、单份暴露技术、双份暴露技术等。本文将介绍食用香料的风险评估方法。     

Comparison of stochastic modelling of the intakes of intentionally added flavouring substances with theoretical added maximum daily intakes (TAMDI) and maximized survey-derived daily intakes (MSDI).

Estimates of exposure to intentionally added flavouring substances based on two indirect methods, namely the theoretical added maximum daily intake (TAMDI) and maximized survey-derived daily intake (MSDI), were compared with exposure estimates based on a flavourings stochastic model (FSM). Twelve flavouring substances were chosen to reflect broadly the large number of flavouring substances currently used in Europe. Over 40,000 flavour formulae used at known levels of incorporation in 31 different categories of food and beverages were examined to provide maximum concentrations, distributions of concentrations and an indication of the probability of encountering each substance in a flavoured food or beverage in any category. Food consumption data were based on the intakes of males, aged 16-24 years, according to the Dietary and Nutritional Survey of British Adults (1988). The percentage of flavoured brands within food groups was estimated using the Irish National Food Ingredient Database. For all 12 flavouring substances, the estimates of TAMDI were > 97.5th percentile of the FSM, sometimes by > 3 orders of magnitude. With the exception of 2,6-dimethyl pyrazine, the 97.5th percentile of the FSM was less than the MSDI estimate. The probability of the FSM estimates exceeding the TAMDI ranged from < 0.0001 to 0.0037 for the 12 substances, while the probability of exceeding the MSDI estimates ranged from 0.0004 to 0.0753. The study supports the findings of a recent publication using detailed dietary analysis of US data that also indicated that the MSDI appeared, within the limits of the studies, to be a practical and conservative method for assessing exposure to intentionally added flavouring substances.     

Risk assessment of dietary exposure to aluminium in the Chinese population

In order to address the issue of excessive intake of aluminium (Al) from Al-containing food additives in the Chinese diet, this study conducted a dietary exposure assessment of Al in the general population based on the national surveillance data of Al content in foods and national food consumption data. It was found that the mean dietary exposure of the whole Chinese population to Al from Al-containing food additives was 1.795 mg kg^?1 bw week^?1, not exceeding the PTWI, while high dietary exposures (e.g., 97.5^th percentile) to Al were 7.660 and 2.103–2.903 mg kg^?1 bw week^?1 for children, respectively, both exceeding the PTWI. It was found that the dietary exposure to Al for 32.5% of the total Chinese population and 42.6% of children aged 4–6 years exceeded the PTWI. Wheat flour and wheat-based products are the main source of dietary A l exposure (85% of the total intake); and puffed foods are the major source of Al intake for children. These findings suggested that consumption of Al-containing food additives could be a health concern for consumers with high food consumption (97.5^th percentile) and children under the age of 14 years.     

Dietary exposure of the Belgian population to emulsifiers E481 (sodium stearoyl-2-lactylate) and E482 (calcium stearoyl-2-lactylate)

A dietary exposure assessment of food emulsifiers E481 (sodium stearoyl-2-lactylate) and E482 (calcium stearoyl-2-lactylate) in the Belgian population was performed. Nationally representative food consumption data from the Belgian National Food Consumption Surveys 2004 (BNFCS2004) and 2014 (BNFCS2014) were used for calculations. A conservative approach (combining individual food consumption data with the maximum permitted level (MPL) of foods (tier 2), was compared with more refined estimates (combining individual food consumption data with actual concentrations measured in food products available on the Belgian market (tier 3)). Estimated daily intakes were compared to the acceptable daily intake (ADI) of the stearoyl-2-lactylates. The results of tier 2 demonstrated that 92% of the children (3–9 years), 53% of the adolescents (10–17 years), 15% of the adults (18–64 years) and 26% of the elderly (64–98 years) had a potential intake higher than the ADI. When replacing the MPL with maximum analysed concentration levels in foods, daily intake estimates decreased dramatically. The estimated daily intake of the food emulsifiers was below the ADI for all age groups, except for a small percentage of children (1.9%) for which the intake exceeded the ADI. The main contributors to the exposure of E481 and E482 were bread, rolls and fine bakery wares.     

Health risk assessment of Chinese consumers to nickel via dietary intake of foodstuffs

A quantitative risk assessment was carried out to characterise the health risk from nickel (Ni) via dietary exposure for Chinese consumers. Ni contamination in foods was investigated by conducting a survey and a literature review. The daily diet of the public was categorised into nine food groups and the consumption data for each group were obtained from a nationwide survey. Deterministic and probabilistic methods were applied to calculate the target hazard quotients (THQs) by comparing the estimated dietary Ni intake with respect to the tolerable daily intake (TDI). The average estimated daily Ni intake (μg kg^–1 bw day^–1) for men, women, 2–3-year-old children and 4–17-year-old children were 7.2, 7.3, 17.1 and 10.0, respectively. The consumption of cereals, beans, vegetables and marine products contributed significantly to the total daily intake of Ni. The mean THQ values (95% confidence interval) and the probability of dietary Ni exposure higher than the TDI were 0.60 (0.58–0.62) and 8.2% for men, 0.61 (0.59–0.63) and 8.4% for women, 1.35 (1.32–1.39) and 72.0% for 2–3-year-old children, and 0.87 (0.82–0.91) and 28.5% for 4–17-year-old children, respectively. This study showed a potential health risk from Ni via dietary exposure for Chinese consumers, especially among children.     

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

ABSTRACT

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.     

Light-induced Flavour Deterioration. Exposure of Potato Crisps to Light and its Effect on Subsequent Storage in the Dark

The flavour changes and extent of oxidation in crisps that had been exposed to light were studied by flavour difference assessment and peroxide value. When the crisps were examined immediately after illumination, both mean flavour difference ratings and peroxide values increased with the duration of exposure. When the crisps were stored for different periods after a fixed duration of exposure, an increase of flavour difference was observed without concomitant increase in peroxide value. The observation that the storage in the dark after illumination is different to exposure to light alone is significant because actual conditions of storage of food products usually involve both light and dark periods.     

Long-term dietary exposure to lead in young European children: comparing a pan-European approach with a national exposure assessment

Long-term dietary exposures to lead in young children were calculated by combining food consumption data of 11 European countries categorised using harmonised broad food categories with occurrence data on lead from different Member States (pan-European approach). The results of the assessment in children living in the Netherlands were compared with a long-term lead intake assessment in the same group using Dutch lead concentration data and linking the consumption and concentration data at the highest possible level of detail. Exposures obtained with the pan-European approach were higher than the national exposure calculations. For both assessments cereals contributed most to the exposure. The lower dietary exposure in the national study was due to the use of lower lead concentrations and a more optimal linkage of food consumption and concentration data. When a pan-European approach, using a harmonised food categorisation system and “European” concentration data, results in a possible health risk related to the intake of an environmental chemical for a certain country, it is advisable to refine this assessment, as part of a tiered approach, using national occurrence data, including an optimised linkage between foods analysed and consumed for that country. In the case of lack of occurrence data, these data can be supplemented with data from the “European” concentration database or by generating additional concentration data at country level.     

Use and impact of usual intake models on dietary exposure estimate and risk assessment of chemical substances: a practical example for cadmium,acrylamide and sulphites

To estimate of food and nutrient intakes, 24-h recalls are frequently used in dietary assessment. However intake data collected for a short period are a limited estimator of long-term usual intake. An important limitation of such data is that the within-person variability tends to inflate the intake distribution leading to a biased estimation of extreme percentiles. Statistical models, named usual-intake models, that separate the within-person variability from the between-persons variability, have lately been implemented. The main objectives of this study were to highlight the potential impact that usual-intake models can have on exposure estimate and risk assessment and to point out which are the key aspects to be considered in order to run these models properly and be sure to interpret the output correctly. To achieve the goal we used the consumption data obtained by the French dietary survey INCA2 and the concentration data collected during the French TDS2, using Monte Carlo Risk Assessment (MCRA) software, release 8.0. For the three substances included in this study (cadmium, acrylamide and sulphites), the exposure of the upper percentiles was significantly reduced when using usual-intake models in comparison with the results obtained in the observed individual mean models, even if in terms of risk assessment the impact of using usual-intake models was limited. From the results it appears that the key aspects to consider when using usual-intake models are: (1) the normality of the log-transformed intake distribution, (2) the contribution per single food group to the total exposure, and (3) the independency of food consumption data on multiple days. In conclusion, usual-intake models may have an impact on exposure estimates although, referring to the results, it did not bring any changes in terms of risk assessment, but further investigations are needed.     

Predictors for Reporting of Dietary Assessment Methods in Food-based Randomized Controlled Trials over a Ten-year Period

The importance of monitoring dietary intake within a randomized controlled trial becomes vital to justification of the study outcomes when the study is food-based. A systematic literature review was conducted to determine how dietary assessment methods used to monitor dietary intake are reported and whether assisted technologies are used in conducting such assessments. OVID and ScienceDirect databases 2000–2010 were searched for food-based, parallel, randomized controlled trials conducted with humans using the search terms “clinical trial,” “diet$ intervention” AND “diet$ assessment,” “diet$ method$,” “intake,” “diet history,” “food record,” “food frequency questionnaire,” “FFQ,” “food diary,” “24-hour recall.” A total of 1364 abstracts were reviewed and 243 studies identified. The size of the study and country of origin appear to be the two most common predictors of reporting both the dietary assessment method and details of the form of assessment. The journal in which the study is published has no impact. Information technology use may increase in the future allowing other methods and forms of dietary assessment to be used efficiently.     

江西省居民膳食中山梨酸及其钾盐暴露风险评估

目的评估江西省居民膳食中山梨酸及其钾盐的暴露水平和潜在健康风险。方法利用2012—2016年江西省食品中山梨酸及其钾盐含量数据、2016年江西省居民食物消费量调查数据,采用简单分布评估法计算江西省居民膳食中山梨酸及其钾盐的暴露水平,并进行健康风险评估。结果江西省居民膳食中山梨酸及其钾盐每日平均暴露量及每日高暴露量(P95)分别为0.031和0.085 mg/kg BW,分别占暂定组每日允许摄入量(ADI,3 mg/kg BW)的1.03%和2.83%。西式糕点、大米制品、熟肉制品是江西省居民膳食中山梨酸及其钾盐暴露的主要来源,贡献率达到总膳食暴露量的75%以上。如果严格执行GB 2760—2014《食品安全国家标准食品添加剂使用标准》中关于山梨酸及其钾盐限量规定,江西省居民膳食中山梨酸及其钾盐每日平均暴露量和每日高暴露量分别下降25.7%～49.5%和14.5%～27.9%,西式糕点、果蔬汁类饮料、新型豆制品则成为膳食中山梨酸及其钾盐暴露的主要来源。结论目前江西省居民膳食中山梨酸及其钾盐暴露量对人群健康造成的风险较低,处于可接受水平,但仍有部分暴露来源于食品添加剂滥用,需要关注。     

Comparison of two methods to assess the intake of flavouring substances

It is important to assess the intake of flavouring substances in order to be confident that exposure to the substance from its intended use presents no significant risk. A number of methods exist to estimate intake of food ingredients. Two such methods, one using a detailed dietary analysis based on food consumption and composition and one using 10 times the annual volume of use on a per capita basis (per capita x 10), were compared for their precision and practicality in assessing the intake of 10 flavouring substances. The detailed dietary analysis method of determining exposure resulted in good estimates of the distribution of intakes across the population, as well as patterns of intake of individuals. This method is both expensive and labour intensive. The per capita x 10 method yields results that, compared with those obtained by detailed dietary analysis, tend consistently to overstate exposure. Thus, this method is a conservative and practical approach to assessing exposure to flavouring substances and other food ingredients.     

农药残留膳食暴露评估模型研究进展

农药残留膳食暴露风险评估为化学品风险管理、食品安全与人类健康领域的重点关注问题，有效的定量风险评估模型是开展农药残留膳食暴露评价的基础工具。本文结合国内外农药残留膳食暴露风险评估研究进展，旨在归纳农药残留膳食暴露风险评估模型，包括确定性评估模型、概率性评估模型和累积性评估模型；根据模型演变、适用情形与评估需求，比对分析模型间优缺点，探讨模型不确定度、评估软件、数据库应用等关键因子。同时立足我国农药残留膳食风险评估现状，展望模型相关参数整合的紧迫性与重要性，为完善农药残留膳食暴露风险评估体系建设提供科学参考。     

Exposure assessment of food preservatives (sulphites,benzoic and sorbic acid) in Austria

An exposure assessment was performed to estimate the potential intake of preservatives in the Austrian population. Food consumption data of different population groups, such as preschool children aged 3–6 years, female and male adults aged 19–65 years were used for calculation. Levels of the preservatives in food were derived from analyses conducted from January 2007 to August 2010. Dietary intakes of the preservatives were estimated and compared to the respective acceptable daily intakes (ADIs). In the average-intake scenario, assuming that consumers randomly consume food products that do or do not contain food additives, estimated dietary intakes of all studied preservatives are well below the ADI for all population groups. Sulphite exposure accounted for 34%, 84% and 89% of the ADI in preschool children, females and males, respectively. The mean estimated daily intake of benzoic acid was 32% (preschool children), 31% (males) and 36% (females) of the ADI. Sorbic acid intakes correspond to 7% of the ADI in preschool children and 6% of the ADI in adults. In the high-intake scenario assuming that consumers always consume food products that contain additives and considering a kind of brand loyalty of consumers, the ADI is exceeded for sulphites among adults (119 and 124%, respectively). Major contributors to the total intake of sulphites were wine and dried fruits for adults. Mean estimated dietary intakes of benzoic acid exceeded the ADI in all population groups, 135% in preschool children, 124% in females and 118% of the ADI in males, respectively. Dietary intakes of sorbic acid are well below the ADI, accounting for a maximum of 30% of the ADI in preschool children. The highest contributors to benzoic and sorbic acid exposure were fish and fish products mainly caused by high consumption data of this large food group, including also mayonnaise-containing fish salads. Other important sources of sorbic acid were bread, buns and toast bread and fruit and vegetable juices.     

Tiered intake assessment for food colours

ABSTRACT

A tiered intake assessment approach, ranging from the conservative default and refined budget method to refined dietary exposure assessments using national food consumption surveys is presented and applied to derive maximum potential global colour intake estimates. The US and UK markets served as representative for the world and the EU, respectively, to determine the maximum potential exposure ceilings for eleven colours in various sub-populations, including brand-loyal consumers. Industry-reported global use levels were assigned as the maximum level. Conservative intake assessments for food colours used in non-alcoholic beverages were estimated for the general population 2 + y, toddlers, children 3–9 y, adolescents 10–17 y, adults 18–64 y, elderly 65–74 y, very elderly 75 + y based on assumed uses in high intake markets. Refined dietary exposures were estimated using either the 2-day food consumption data from the 2013–2016 US National Health and Nutrition Examination Survey or the 4-day food consumption data from the 2008–2016 U.K. National Diet and Nutrition Survey Rolling Programme. In the most refined market-share adjusted assessment, brand-specific market volume data were used to place appropriate weight on corresponding beverage type uses. Strong concordance between the refined budget method and the brand-loyal deterministic approach was shown, in which the latter assumes that the maximum use level of the colour is present in 100% of non-alcoholic beverages. This study shows that safety of colours – both synthetic and natural – in beverages at proposed use levels can be supported for any geography, with all intake estimates falling below the acceptable daily intake in refined assessments. Importantly, this study demonstrates that the refined budget method is a valid first-tier screening assessment to prioritise food colours that may benefit from more refined intake assessments when warranted.     

Sampling design by the core-food approach for the Taiwan total diet study on veterinary drugs

ABSTRACT

The core-food (CF) approach, first adopted in the United States in the 1980s, has been widely used by many countries to assess the exposure to dietary hazards at a population level. However, the reliability of exposure estimates (C × CR) depends critically on sampling methods designed for the detected chemical concentrations (C) of each CF to match with the corresponding consumption rate (CR) estimated from the surveyed intake data. In order to reduce the uncertainty of food matching, this study presents a sampling design scheme, namely the subsample method, for the 2016 Taiwan total diet study (TDS) on veterinary drugs. We first combined the four sets of national dietary recall data that covered the entire age strata (1–65+ years), and aggregated them into 307 CFs by their similarity in nutritional values, manufacturing and cooking methods. The 40 CFs pertinent to veterinary drug residues were selected for this study, and 16 subsamples for each CF were designed by weighing their quantities in CR, product brands, manufacturing, processing and cooking methods. The calculated food matching rates of each CF from this study were 84.3–97.3%, which were higher than those obtained from many previous studies using the representative food (RF) method (53.1–57.8%). The subsample method not only considers the variety of food processing and cooking methods, but also it provides better food matching and reduces the uncertainty of exposure assessment.     

Dietary exposure to aluminium from wheat flour and puffed products of residents in Shanghai,China

A dietary survey of 3431 residents was conducted by a 24-h dietary recall method in Shanghai, China, quarterly from September 2013 to September 2014. A total of 400 food samples were tested for aluminium concentration, including wheat flour and puffed products from 2011 to 2013. Probabilistic analysis was used to estimate the dietary exposure to aluminium from wheat and puffed products. The means of dietary aluminium exposure for children (2–6 years old), juveniles (7–17 years old), adults (18–65 years old) and seniors (over 65 years old) were 1.88, 0.94, 0.44 and 0.42 mg kg^?1 body weight (bw) week^?1 respectively, with a population average of 0.51 mg kg^?1 bw week^?1. The proportions of those who had aluminium exposure from wheat and puffed products lower than the provisional tolerable weekly intake (PTWI) were 77%, 90%, 97%, and 97% respectively from children to seniors. We estimated that the proportions of people at risk would decrease by 13%, 6%, 2% and 2% respectively under the new China National Standards – GB 2760–2014 National Food Safety for Standards for using food additives. The results indicated that aluminium from wheat flour and puffed products is unlikely to cause adverse health effects in the general population in Shanghai; however, children were at a higher risk of excess aluminium exposure. Significant improvements in reducing the dietary exposure to aluminium are expected in the population, especially for children after the implementation of GB 2760–2014.     

Statistical method to assess usual dietary intakes in the European population

Food consumption data are a key element of EFSA’s risk assessment activities, forming the basis of dietary exposure assessment at the European level. In 2011, EFSA released the Comprehensive European Food Consumption Database, gathering consumption data from 34 national surveys representing 66,492 individuals from 22 European Union member states. Due to the different methodologies used, national survey data cannot be combined to generate European estimates of dietary exposure. This study was executed to assess how existing consumption data and the representativeness of dietary exposure and risk estimates at the European Union level can be improved by developing a ‘Compiled European Food Consumption Database’. To create the database, the usual intake distributions of 589 food items representing the total diet were estimated for 36 clusters composed of subjects belonging to the same age class, gender and having a similar diet. An adapted form of the National Cancer Institute (NCI) method was used for this, with a number of important modifications. Season, body weight and whether or not the food was consumed at the weekend were used to predict the probability of consumption. A gamma distribution was found to be more suitable for modelling the distribution of food amounts in the different food groups instead of a normal distribution. These distributions were combined with food correlation matrices according to the Iman–Conover method in order to simulate 28 days of consumption for 40,000 simulated individuals. The simulated data were validated by comparing the consumption statistics of the simulated individuals and food groups with the same statistics estimated from the Comprehensive Database. The opportunities and limitations of using the simulated database for exposure assessments are described.     

Dietary intake of trace elements by the population of Catalonia (Spain): results from a total diet study

This study aimed to analyse the concentrations of Al, Ba, Bi, Cu, Cr, Ge, Mn, Mo, Ni, Sb, Se, Sr and Zn in food samples collected in 2008 in Catalonia (Spain). The dietary intake of these 13 trace elements was subsequently estimated by different age–gender groups of the population: children, adolescents, adults and seniors. In general terms, fish and shellfish, cereals, and pulses were the food groups showing the highest levels for most elements. Higher dietary intakes were associated with male groups (adolescents, adults and seniors). However, none exceeded the tolerable levels. When exposure was estimated based on body weight, children were the group with the highest dietary intake. Notwithstanding, only the weekly intake of Al by children exceeded the recommendations of the European Food Safety Authority (EFSA). It is a consequence of the higher intake of cereals in relation to their respective body weights. In addition to the periodical food surveillance of toxic metals (As, Cd, Hg and Pb), it is also important to determine the levels of other trace elements in order to ensure that the dietary exposure by the Catalan population is under control.     

Assessment of dietary exposure of young Chinese children to aluminium residues

The aim of this study was to assess the Al dietary exposure of young Chinese children aged 0–3 years via formulae, complementary foods and wheat-based foods. Al residue data were obtained from the national food contamination monitoring programme from 2013 to 2016, encompassing 13,833 samples of 12 food items with a detection rate of 76.0%. Food consumption data were gathered from the China National Food Consumption Survey conducted in 2015, comprising 20,172 children aged 0–3 years old. The mean dietary exposure to Al for the general population of young Chinese children was estimated at 0.76 mg/kg bw/week, which does not exceed the PTWI. The 97.5th percentile intakes of Al reached 3.42 mg/kg bw/week, more than 1.7 times the PTWI. Wheat-based foods contributed 80.5% of the Al intake for the general population of young Chinese children, while formulae and complementary foods accounted for 19.5% of the total intake. The dietary intake of Al from formulae and complementary foods accounted for 6.0% and 1.6% of PTWI, respectively. These findings suggested that dietary exposure to Al among the general population of young Chinese children was lower than the PTWI and that there are no health concerns related to this level of Al intake. However, more attention should be placed on the health risks associated with Al exposure from wheat-based foods for young consumers with high food consumption in China (97.5th percentile)