Estimated daily intake and safety of FD&C food-colour additives in the US population

ABSTRACT

A refined exposure assessment was undertaken to calculate the estimated daily intake (EDI) of the seven FD&C straight-colour additives and five FD&C colour lakes (‘synthetic’ food colours) approved in the United States. The EDIs were calculated for the US population as a whole and specific age groups, including children aged 2–5 and 6–12 years, adolescents aged 13–18 years, and adults aged 19 or more y. Actual use data were collected from an industry survey of companies that are users of these colour additives in a variety of products, with additional input from food colour manufacturers. Food-consumption data were obtained from the National Health and Nutrition Examination Survey (NHANES). The assessment was further refined by adjusting the intake to more realistic scenarios based on the fraction of products containing colour within specific food categories using data provided by the Mintel International Group Ltd. The results of the analysis indicate that (1) the use levels reported by the industry are consistent with the concentrations measured analytically by the US Food and Drug Administration; and (2) exposure to food-colour additives in the United States by average and high-intake consumers is well below the acceptable daily intake (ADI) of each colour additive as published by the Joint WHO/FAO Committee on Food Additives (JECFA) and allows wide margins of safety. It is concluded that food colour use as currently practised in the United States is safe and does not result in excessive exposure to the population, even at conservative ranges of food consumption and levels of use.     

A U.S. population dietary exposure assessment for 4-methylimidazole (4-MEI) from foods containing caramel colour and from formation of 4-MEI through the thermal treatment of food

ABSTRACT

4-Methylimidazole (4-MEI) is formed in caramel colours produced using ammonium compounds (Class III and Class IV caramel colours). 4-MEI can also form in food through Maillard reactions between reducing sugars and amino acids during cooking, roasting or dry-heating. The USFDA has analysed over 700 food and beverage samples collected from 2013 to 2015 for the presence of 4-MEI. These samples include foods containing added caramel colour and foods that are not labelled as containing added caramel colour, but which may contain 4-MEI resulting from thermal treatment. The 4-MEI levels in all food samples were quantified using LC-MS/MS. These data were used to develop a comprehensive dietary exposure assessment for 4-MEI for the U.S. population aged 2 years or more and several sub-populations, using two non-consecutive days of food consumption data from the combined 2009–2012 National Health and Nutrition Examination Survey and 10–14-day food consumption survey data for 2009–2012 from the NPD Group, Inc. National Eating Trends–Nutrient Intake Database. Dietary exposure estimates were prepared for each category of foods labelled as containing added caramel colour and of foods not labelled as containing added caramel colour, but which may contain 4-MEI from thermal treatment. Exposure to 4-MEI from consumption of foods containing added caramel colour was higher than that from foods that contain 4-MEI from thermal treatment for all population groups. Cola-type carbonated beverages were the highest contributors for most populations from foods containing added caramel colour. Coffee was the highest contributor for most populations from foods in which 4-MEI could be formed from thermal treatment. An overall combined exposure to 4-MEI was also estimated that included all foods identified as containing added caramel colour and foods in which 4-MEI could be formed by thermal treatment.     

Dietary intake assessment of caramel colours and their processing by-products 4-methylimidazole and 2-acetyl-4-tetrahydroxy-butylimidazole for the Chinese population

ABSTRACT

The aim of the study was to assess the dietary intake of caramel colours and their by-products 4-methylimidazole (4-MEI) and 2-acetyl-4-tetrahydroxybutylimidazole (THI) for the Chinese population. Based on the typical and maximum reported use levels of caramel colours in 15 food categories, the dietary intakes of combined and single-class caramel colours of Classes I, III and IV were estimated with the food consumption data from the China National Nutrient and Health Survey. Using the mean values of 4-MEI and THI contents in Class III and Class IV Caramel colour samples, the exposures to 4-MEI and THI from dietary caramel colours were derived. The results showed that the combined and individual average dietary caramel colour intakes for the Chinese population of different age groups were estimated to be 232–60.3 mg kg^?1 bw day^?1 for combined caramels, 5.9–29.2 mg kg^?1 bw day^?1 for Class I, 7.7–29.6 mg kg^?1 bw day^?1 for Class III, 21.2–54.3 mg kg^?1 bw day^?1 for Class IV, which were far below the group acceptable daily intake (ADI) and respective ADIs. The combined intake of 4-MEI from Class III and IV caramel colours was estimated to be 3.8–5.2 μg kg^?1 bw day^?1 on average, and 12.9–27.1 μg kg^?1 bw day^?1 at 95th-97.5th percentile for the general population. The anticipated exposure to THI from Class III caramel colours was estimated to be 0.1–0.3 μg kg^?1 bw day^?1 on average and 0.5–1.7 μg kg^?1 bw day^?1 at 95th–97.5th percentile for the general population. The dietary caramel colours intakes and the exposures to 4-MEI and THI from dietary caramel colour for the Chinese population were considered to be of low health concern based on the present toxicological data. Soy sauce, vinegar and compound seasonings were found to be the main contributors to the dietary intake of caramel colours.     

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.     

Estimate of dietary exposure to sulphites in child and adult populations in the Basque Country

Sulphites are widely used as a preservative and antioxidant additive in food. The aim of this study was to assess dietary sulphite intake in adults aged 35–65 years and in children aged 4–18 years living in the Basque Country, northern Spain. We determined sulphite concentrations in 909 samples covering 16 food types. The maximum permitted levels were exceeded in 17% of samples. Making recommended assumptions for non-quantifiable results, estimates of mean lower and upper bounds were calculated for sulphite concentrations in each food type. These sulphite data were combined with consumption data derived from 8417 adults from the European Prospective Investigation in Cancer and Nutrition cohort in Gipuzkoa, recruited in 1992–1995 using a diet history method, and 1055 children from the Basque Country Nutrition Children Survey, conducted in 2004–2005 using two 24-h recall questionnaires to assess diet. The results were compared with the acceptable daily intake (ADI) proposed by the Joint Expert Committee on Food Additives (JECFA). The mean dietary exposure to sulphites was 0.08 mg kg^?1 bw day^?1, only 11% of the ADI in the overall group of children (4–18 years old), but the acceptable intake was exceeded by 4% of 4–6 year olds. For the adults (35–65 years old), the mean dietary exposure was 0.31 mg kg^?1 bw day^?1, 45% of the ADI, but the acceptable intake was exceeded in 14.6% of cases. The major contributing foods were minced meat and other meat products for children and wine for adults.     

Exposure assessment to synthetic food colours of a selected population in Hyderabad, India

An exposure assessment of synthetic food colours was carried out among 1-5- and 6-18-year-old individuals by the food frequency method. Children had an intake of solid food consumption in the range 2-465 g day^-1 and liquid food consumption in the range 25-840 ml day^-1 with added colours. Among the eight permitted colours in India, six were consumed by the subjects of the study. The intakes of some subjects exceeded the acceptable daily intake for colours such as tartrazine, sunset yellow and erythrosine, which is 7.5, 2.5 and 0.1 mg kg^-1 body weight, respectively. Therefore, a uniform permissible limit of 100 mg kg^-1 prescribed under the Prevention of Food Adulteration Act in India for all foods is not justified. The limits need to be revised according to the Codex Alimentarius Commission, which permits different maximum levels of additives to various food categories based on both the extent of consumption and the technological justification for its use.     

Exposure estimate for FD&C colour additives for the US population

Dietary exposures to the seven food, drug, and cosmetic (FD&C) colour additives that are approved for general use in food in the United States were estimated for the US population (aged 2 years and older), children (aged 2–5 years) and teenage boys (aged 13–18 years) based on analytical levels of the FD&C colour additives in foods. Approximately 600 foods were chosen for analysis, based on a survey of product labels, for the levels of FD&C colour additives. Dietary exposure was estimated using both 2-day food consumption data from the combined 2007–10 National Health and Nutrition Examination Survey (NHANES) and 10–14-day food consumption data from the 2007–10 NPD Group, Inc. National Eating Trends – Nutrient Intake Database (NPD NET-NID). Dietary exposure was estimated at the mean and 90th percentile using three different exposure scenarios: low exposure, average exposure and high exposure, to account for the range in the amount of each FD&C colour additive for a given food. For all populations and all exposure scenarios, the highest cumulative eaters-only exposures in food were determined for FD&C Red No. 40, FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition, the eaters-only exposure was estimated for individual food categories in order to determine which food categories contributed the most to the exposure for each FD&C colour additive. Breakfast Cereal, Juice Drinks, Soft Drinks, and Frozen Dairy Desserts/Sherbet (also referred to as Ice Cream, Frozen Yogurt, Sherbet (including Bars, Sticks, Sandwiches)) were the major contributing food categories to exposure for multiple FD&C colour additives for all three populations.     

Bisphenol A contamination in soft drinks as a risk for children’s health in Italy

Bisphenol A (BPA) was determined in sugary carbonated, non-carbonated and milk-based beverages, through HLPC-fluorescence detection and confirmed by LC-MS/MS, in a selection of brands that are mostly consumed by Italian children. The daily intake was determined through the WHO budget method (BM). BPA was found at detectable levels in 57% of carbonated beverages, in 50% of non-carbonated and in 100% of milk-based beverages. The median concentrations were 1.24 µg l^–1 (range = < LOD–4.98 µg l^–1) in canned carbonated beverages and 0.18 µg l^–1 (< LOD–1.78 µg l^–1) in non-canned carbonated beverages. In non-carbonated beverages, median concentrations were 0.80 µg l^–1 (< LOD–2.79 µg l^–1) and 0.18 µg l^–1 (< LOD–3.58 µg l^–1), respectively, for canned and non-canned beverages; in milk-based products the BPA median concentration was 3.60 µg l^–1 (1.00–17.65 µg l^–1). BPA daily intake from sugary drink consumption in children ranged from 0.008 to 1.765 µg kg^–1 bw day^–1. The median exposure values for the ‘best’ and ‘worst’ cases were 0.16% and 0.47% respectively of the EFSA t-TDI for BPA (4 µg kg^–1 bw day^–1), and 10.59% and 35.30% of the t-TDI when the maximum levels were considered.     

Assessment of caffeine intake in the Korean population

An improved method for the analysis of caffeine in foods by HPLC was validated by measuring several analytical parameters. The caffeine contents of 1202 products available from Korean markets were analysed. A consumption study was conducted by using data from the Korea National Health and Nutrition Examination Survey (KNHANES), 2010–12, to estimate the caffeine intakes of the Korean population. The mean intakes of caffeine from all sources in the general population and consumers were 67.8 and 102.6 mg day^?1 for all age groups, respectively. The 95th percentile intakes of the general population and consumers were 250.7 and 313.7 mg day^?1, respectively. In those aged 30–49 years, the caffeine intakes of the general population and consumers were highest at 25.5% (101.8 mg kg^?1 day^?1) and 36.6% (0.9 mg kg^?1 day^?1), respectively, compared with the maximum recommended daily intake (400 mg day^?1) for adults. In the general population, the main contributors to the total caffeine intake were carbonated beverage for the younger age groups and coffee for the adults. These data provide a current perspective on caffeine intake in the Korean population.     

Dietary exposure assessment of synthetic food colours using analytical concentrations in Korea

ABSTRACT

The safety of nine synthetic colour additives approved in Korea were assessed through hazard identification, hazard characterisation, exposure assessment, and risk characterisation. Hazard identification and characterisation were conducted using new risk information based on toxicology data. Exposure assessment calculated the estimated daily intake (EDI) of the nine colours. Finally, the risk was evaluated by comparing the EDIs of the colours with the acceptable daily intake (ADI). 1,114 samples (24 food categories) among a total of 1,454 samples contained colour additives either at a level that was not detectable or up to a quantified maximum of 288 mg kg^?1. The likelihood of risk of exposure to all food colours, evaluated by comparing the EDI with the ADI, was less than 0.52% of the ADI for the general population. These results indicate that use of synthetic food colour in Korea is safe and does not result in excessive exposure to any population group.     

Harmonisation of food categorisation systems for dietary exposure assessments among European children

Within the European project called EXPOCHI (Individual Food Consumption Data and Exposure Assessment Studies for Children), 14 different European individual food consumption databases of children were used to conduct harmonised dietary exposure assessments for lead, chromium, selenium and food colours. For this, two food categorisation systems were developed to classify the food consumption data in such a way that these could be linked to occurrence data of the considered compounds. One system served for the exposure calculations of lead, chromium and selenium. The second system was developed for the exposure assessment of food colours. The food categories defined for the lead, chromium and selenium exposure calculations were used as a basis for the food colour categorisation, with adaptations to optimise the linkage with the food colour occurrence data. With this work, an initial impetus was given to make user-friendly food categorisation systems for contaminants and food colours applicable on a pan-European level. However, a set of difficulties were encountered in creating a common food categorisation system for 14 individual food consumption databases that differ in the type and number of foods coded and in level of detail provided about the consumed foods. The work done and the problems encountered in this project can be of interest for future projects in which food consumption data will be collected on a pan-European level and used for common exposure assessments.     

Harmonisation of food categorisation systems for dietary exposure assessments among European children

Within the European project called EXPOCHI (Individual Food Consumption Data and Exposure Assessment Studies for Children), 14 different European individual food consumption databases of children were used to conduct harmonised dietary exposure assessments for lead, chromium, selenium and food colours. For this, two food categorisation systems were developed to classify the food consumption data in such a way that these could be linked to occurrence data of the considered compounds. One system served for the exposure calculations of lead, chromium and selenium. The second system was developed for the exposure assessment of food colours. The food categories defined for the lead, chromium and selenium exposure calculations were used as a basis for the food colour categorisation, with adaptations to optimise the linkage with the food colour occurrence data. With this work, an initial impetus was given to make user-friendly food categorisation systems for contaminants and food colours applicable on a pan-European level. However, a set of difficulties were encountered in creating a common food categorisation system for 14 individual food consumption databases that differ in the type and number of foods coded and in level of detail provided about the consumed foods. The work done and the problems encountered in this project can be of interest for future projects in which food consumption data will be collected on a pan-European level and used for common exposure assessments.     

Usage pattern of synthetic food colours in different states of India and exposure assessment through commodities preferentially consumed by children

Exposure studies in children are emphasized nowadays given children's higher consumption vulnerability. The present study generated national-level data covering 16 major states of India on the usage pattern of colours and it identified food commodities through which a particular colour has the scope to exceed ADI limits. Out of the total analysed samples, 87.8% contained permitted colours, of which only 48% adhered to the prescribed limit of 100?mg?kg^?1. The majority of candyfloss, sugar toys, beverages, mouth fresheners, ice candy and bakery product samples exceeded the prescribed limit. Non-permitted colours were mostly prevalent in candyfloss and sugar toy samples. Though sunset yellow FCF (SSYFCF) and tartrazine were the two most popular colours, many samples used a blend of two or more colours. The blend of SSYFCF and tartrazine exceeded the prescribed limit by a factor of 37 in one sample, and the median and 95th percentile levels of this blend were 4.5- and 25.7-fold, respectively. The exposure assessment showed that the intake of erythrosine exceeded the ADI limits by two to six times at average levels of detected colours, whereas at the 95th percentile level both SSYFCF and erythrosine exceeded the respective ADI limits by three- to 12-fold in all five age groups. Thus, the uniform prescribed limit of synthetic colours at 100?mg?kg^?1 under Indian rules needs to be reviewed and should be governed by consumption profiles of the food commodities to check the unnecessary exposure of excessive colours to those vulnerable in the population that may pose a health risk.     

Estimate of the theoretical maximum daily intake of Sunset Yellow FCF by the Brazilian population

ABSTRACT

This study estimated the theoretical maximum daily intake (TMDI) of Sunset Yellow (SY) synthetic food dye by the Brazilian population through food consumption data from the Household Budget Survey (HBS) of the Brazilian Institute of Geography and Statistics (IBGE, 2008/09). The study covered the population in urban and rural areas in the five regions of the country, and from different age groups, in order to verify if it were possible to exceed the acceptable daily intake (ADI) of SY, which is 4.0 mg kg^–1 body weight. This was assessed by cross-checking food products containing this dye from the largest supermarket chains in Brazil with data from the HBS-IBGE 2008/09. These data showed that the average consumption of SY per capita did not exceed the ADI in any of the aforementioned population groups. However, when considering food consumption in urban and rural areas (279 and 260 mg of SY day^–1), in the five regions of the country (260–338 mg of SY day^–1), and for adolescents (332 mg SY day^–1), it is noted that part of the population could be exceeding the recommended ADI, which may pose health risks. Although it is unlikely that individuals will exceed the SY ADI, this may occur in some cases, especially for younger people.     

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.     

Dietary intake of four artificial sweeteners by Irish pre-school children

In spite of rigorous pre- and post-market reviews of safety, there remains a high level of debate regarding the use of artificial sweeteners in foods. Young children are of particular interest when assessing food chemical exposure as a result of their unique food consumption patterns and comparatively higher exposure to food chemicals on a body weight basis when compared with the general population. The present study examined the intakes of four intense sweeteners (acesulfame K, aspartame, saccharin, sucralose) in the diets of children aged 1–4 years using food consumption and sweetener presence data from the Irish National Pre-school Nutrition Survey (2010–11) and analytical data for sweetener concentration in foods obtained from a national testing programme. Four exposure assessment scenarios were conducted using the available data on sweetener occurrence and concentration. The results demonstrated that the mean daily intakes for all four sweeteners were below the acceptable daily intake (ADI) (17–31%), even considering the most conservative assumptions regarding sweetener presence and concentration. High consumer intakes (P95) were also below the ADI for the four sweeteners when more realistic estimates of exposure were considered. Both sweetener occurrence and concentration data had a considerable effect on reducing the estimated intake values, with a combined reduction in intakes of 95% when expressed as a proportion of the ADI. Flavoured drinks were deemed to be a key contributor to artificial sweetener intakes in this population cohort. It was concluded that there is no health risk to Irish pre-school children at current dietary intake levels of the sweeteners studied.     

Impact of refining the assessment of dietary exposure to cadmium in the European adult population

Exposure assessment constitutes an important step in any risk assessment of potentially harmful substances present in food. The European Food Safety Authority (EFSA) first assessed dietary exposure to cadmium in Europe using a deterministic framework, resulting in mean values of exposure in the range of health-based guidance values. Since then, the characterisation of foods has been refined to better match occurrence and consumption data, and a new strategy to handle left-censoring in occurrence data was devised. A probabilistic assessment was performed and compared with deterministic estimates, using occurrence values at the European level and consumption data from 14 national dietary surveys. Mean estimates in the probabilistic assessment ranged from 1.38 (95% CI = 1.35–1.44) to 2.08 (1.99–2.23) µg kg^–1 bodyweight (bw) week^–1 across the different surveys, which were less than 10% lower than deterministic (middle bound) mean values that ranged from 1.50 to 2.20 µg kg^–1 bw week^–1. Probabilistic 95th percentile estimates of dietary exposure ranged from 2.65 (2.57–2.72) to 4.99 (4.62–5.38) µg kg^–1 bw week^–1, which were, with the exception of one survey, between 3% and 17% higher than middle-bound deterministic estimates. Overall, the proportion of subjects exceeding the tolerable weekly intake of 2.5 µg kg^–1 bw ranged from 14.8% (13.6–16.0%) to 31.2% (29.7–32.5%) according to the probabilistic assessment. The results of this work indicate that mean values of dietary exposure to cadmium in the European population were of similar magnitude using determinist or probabilistic assessments. For higher exposure levels, probabilistic estimates were almost consistently larger than deterministic counterparts, thus reflecting the impact of using the full distribution of occurrence values to determine exposure levels. It is considered prudent to use probabilistic methodology should exposure estimates be close to or exceeding health-based guidance values.     

Determination of phthalate esters in non-alcoholic beverages by GC–MS and optimization of the extraction conditions

A quantificational method for 7 phthalate esters in non-alcoholic beverages was developed. Dimethyl phthalate, di-ethyl phthalate, di-propyl phthalate (DPP), di-butyl phthalate (DBP), benzyl butyl phthalate, di-(2-ethylhexyl) phthalate (DEHP), and di-octyl phthalate (DOP) were extracted from non-alcoholic beverages with the optimized solid-phase extraction method, and quantification was achieved by gas chromatography–mass spectrometry with isotope internal standard of d₄-di-(2-ethylhexyl) phthalate (DEHP-d₄). The inter-day method repeatability (RSD) was 8–13 %, whereas the intra-day method repeatability (RSD) was 9–15 %. The mean spiking recoveries were 84–105 %. A wide variety of phthalate concentrations was observed in 48 non-alcoholic beverages. DEHP was the most abundant phthalate compound followed by DBP, DPP, and DOP. DEHP was found in sport drinks (0.015–0.098 mg L^?1), tea (0.016–0.123 mg L^?1), coffee (0.028–0.159 mg L^?1), and fruit juices (0.022–0.126 mg L^?1).     

Quantitative risk assessment on the dietary exposure of Finnish children and adults to nitrite

Nitrite intake from the consumption of cured meat and tap water was estimated for Finnish children of 1, 3 and 6 years as well as Finnish adults of 25–74 years. Nitrite content in the foods was measured by capillary electrophoresis, and was then used together with individual food consumption data from the FINDIET 2007 and DIPP studies in a stochastic exposure assessment by a Monte Carlo Risk Assessment (MCRA) program. Nitrite intake from additive sources and tap water was assessed, and more than every 10th child between the ages 3 and 6 years was estimated to have a nitrite intake exceeding the acceptable daily intake (ADI) of nitrite. The high exposure levels were caused by frequent consumption of large portions of sausages, up to 350 g day^–1 or 750 g in 3 days, among the children. Median nitrite intake from cured meat was 0.016, 0.040, 0.033 and 0.005 mg kg^–1 body weight day^–1 for children of 1, 3 and 6 years and adults, respectively. Bayesian estimation was employed to determine safe consumption levels of sausages and cold cuts for children, and these results gave rise to new national food consumption advice.