Dietary intake of artificial sweeteners by the Belgian population

This study investigated whether the Belgian population older than 15 years is at risk of exceeding ADI levels for acesulfame-K, saccharin, cyclamate, aspartame and sucralose through an assessment of usual dietary intake of artificial sweeteners and specific consumption of table-top sweeteners. A conservative Tier 2 approach, for which an extensive label survey was performed, showed that mean usual intake was significantly lower than the respective ADIs for all sweeteners. Even consumers with high intakes were not exposed to excessive levels, as relative intakes at the 95th percentile (p95) were 31% for acesulfame-K, 13% for aspartame, 30% for cyclamate, 17% for saccharin, and 16% for sucralose of the respective ADIs. Assessment of intake using a Tier 3 approach was preceded by optimisation and validation of an analytical method based on liquid chromatography with mass spectrometric detection. Concentrations of sweeteners in various food matrices and table-top sweeteners were determined and mean positive concentration values were included in the Tier 3 approach, leading to relative intakes at p95 of 17% for acesulfame-K, 5% for aspartame, 25% for cyclamate, 11% for saccharin, and 7% for sucralose of the corresponding ADIs. The contribution of table-top sweeteners to the total usual intake (<1% of ADI) was negligible. A comparison of observed intake for the total population with intake for diabetics (acesulfame-K: 3.55 versus 3.75; aspartame: 6.77 versus 6.53; cyclamate: 1.97 versus 2.06; saccharine: 1.14 versus 0.97; sucralose: 3.08 versus 3.03, expressed as mg kg(-1) bodyweight day(-1) at p95) showed that the latter group was not exposed to higher levels. It was concluded that the Belgian population is not at risk of exceeding the established ADIs for sweeteners.     

Estimated intake of intense sweeteners from non-alcoholic beverages in Denmark

In 1999, 116 samples of non-alcoholic beverages were analysed for the intense sweeteners cyclamate, acesulfame-K, aspartame and saccharin. High contents of cyclamate close to the maximum permitted level in 1999 of 400 mg l^-1 were found in many soft drinks. The estimated intake of the sweeteners was calculated using the Danish Dietary Survey based on 3098 persons aged 1-80 years. The estimated intake with 90th percentiles of 0.7, 4.0 and 0.2 mg kg^-1 body weight (bw) day^-1 for acesulfame-K, aspartame and saccharin, respectively, was much lower than the acceptable daily intake (ADI) values of 15, 40 and 2.5 mg kg^-1 bw day^-1 for acesulfame-K, aspartame and saccharin, respectively. However, the 90th percentile of the estimated cyclamate intake in 1-3 year olds was close to the ADI value of 7 mg kg^-1 bw day^-1; and the 99th percentile in the 1-10 year olds far exceeded the ADI value. Boys aged 7-10 years had a significantly higher estimated intake of cyclamate than girls. The 90th percentile for the whole population was 1.8 mg kg^-1 bw day^-1. After the reduction in the maximum permitted level in the European Union in 2004 from 400 to 250 mg cyclamate l^-1, the exposure in Denmark can also be expected to be reduced. A new investigation in 2007 should demonstrate whether the problem with high cyclamate intake is now solved.     

Intake of saccharin, aspartame, acesulfame K and cyclamate in Italian teenagers: present levels and projections

The intake of saccharin, aspartame, acesulfame K and cyclamate was assessed in 212 Italian teenagers aged 13-19 in 1996. Total daily intake of intense sweeteners was assessed on the basis of dietary records (14 consecutive days). The sweetener content of sugar-free products (soft drinks, candies, chewing gums, yoghurts, jam and table-top sweeteners) was provided by manufacturers. Sugar-free products were consumed by 77% of the subjects. Mean daily intake among consumers was 0.24mg/kg body weight (bw) for cyclamate (13 subjects), 0.21mg/kg bw for saccharin (9 subjects), 0.03mg/kg bw for aspartame (162 subjects), and 0.02mg/kg bw for acesulfame K (56 subjects). No subject exceeded the ADI (Acceptable Daily Intake) of an intense sweetener. Projections based on the present levels of use of intense sweeteners in sugar-free products and on the dietary pattern observed in the sample suggest that approaching the ADI could be possible only if subjects with high intakes of both soft drinks and table-top sugar substituted these items with respectively sugar-free beverages and table-top sweeteners containing either saccharin or cyclamate.     

Estimated intake of intense sweeteners from non-alcoholic beverages in Denmark, 2005

In 2005, 76 out of 177 analysed samples of non-alcoholic beverages were found to contain the intense sweeteners cyclamate, acesulfame-K, aspartame, and saccharin. The content of cyclamate did not exceed the now permitted maximum level in the European Union of 250 mg l(-1) in soft drinks. The estimated intake of the sweeteners was calculated using the Danish Dietary Survey based on 3098 persons aged 1-80 years. The estimated intake with 90th percentiles of 0.7, 0.8 and 0.2 mg kg(-1) body weight day(-1) for acesulfame-K, aspartame, and saccharin, respectively, was much lower than the acceptable daily intake values of 15, 40, 7, and 2.5 mg kg(-1) body weight day(-1) for acesulfame-K, aspartame, and saccharin, respectively, and on the same level as in the similar investigation from 1999. In contrast to the 1999 investigation, the 90th percentile of the estimated cyclamate intake in 1-3 year olds with 3.7 mg kg(-1) body weight day(-1) was in 2005 lower than the acceptable daily intake of 7 mg kg(-1) body weight day(-1). However, the 99th percentile for 1-3 year olds with 7.4 mg kg(-1) body weight day(-1) still exceeded the acceptable daily intake slightly. The 90th percentile for the whole population with 0.9 mg kg(-1) body weight day(-1) was halved compared with 1999. The reduction in the European Union of the maximum permitted level for cyclamate from 400 to 250 mg l(-1) has brought the intake of cyclamate in small children down to well below the acceptable daily intake value.     

Estimated intake of intense sweeteners from non-alcoholic beverages in Denmark, 2005.

In 2005, 76 out of 177 analysed samples of non-alcoholic beverages were found to contain the intense sweeteners cyclamate, acesulfame-K, aspartame, and saccharin. The content of cyclamate did not exceed the now permitted maximum level in the European Union of 250 mg l(-1) in soft drinks. The estimated intake of the sweeteners was calculated using the Danish Dietary Survey based on 3098 persons aged 1-80 years. The estimated intake with 90th percentiles of 0.7, 0.8 and 0.2 mg kg(-1) body weight day(-1) for acesulfame-K, aspartame, and saccharin, respectively, was much lower than the acceptable daily intake values of 15, 40, 7, and 2.5 mg kg(-1) body weight day(-1) for acesulfame-K, aspartame, and saccharin, respectively, and on the same level as in the similar investigation from 1999. In contrast to the 1999 investigation, the 90th percentile of the estimated cyclamate intake in 1-3 year olds with 3.7 mg kg(-1) body weight day(-1) was in 2005 lower than the acceptable daily intake of 7 mg kg(-1) body weight day(-1). However, the 99th percentile for 1-3 year olds with 7.4 mg kg(-1) body weight day(-1) still exceeded the acceptable daily intake slightly. The 90th percentile for the whole population with 0.9 mg kg(-1) body weight day(-1) was halved compared with 1999. The reduction in the European Union of the maximum permitted level for cyclamate from 400 to 250 mg l(-1) has brought the intake of cyclamate in small children down to well below the acceptable daily intake value.     

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.     

Acceptable daily intake and the regulation of intense sweeteners.

At the present time there are four intense sweeteners that are available in a number of countries: acesulfame-K, aspartame, cyclamate and saccharin. Extensive toxicity databases are available on each sweetener and these have been assessed by both national and international regulatory authorities. This review considers briefly the critical toxicity of each sweetener that is the basis for establishing the no adverse effect level in animal studies. The calculation of an acceptable daily intake (ADI) for human intake employs a large safety factor applied to the no-effect level. The magnitude of the safety factor for each sweetener is discussed in relation to the ADI values recommended by the Scientific Committee for Food in 1985.     

Estimated intake of the artificial sweeteners acesulfame-K, aspartame, cyclamate and saccharin in a group of Swedish diabetics.

Few sweetener intake studies have been performed on the general population and only one study has been specifically designed to investigate diabetics and children. This report describes a Swedish study on the estimated intake of the artificial sweeteners acesulfame-K, aspartame, cyclamate and saccharin by children (0-15 years) and adult male and female diabetics (types I and II) of various ages (16-90 years). Altogether, 1120 participants were asked to complete a questionnaire about their sweetener intake. The response rate (71%, range 59-78%) was comparable across age and gender groups. The most consumed 'light' foodstuffs were diet soda, cider, fruit syrup, table powder, table tablets, table drops, ice cream, chewing gum, throat lozenges, sweets, yoghurt and vitamin C. The major sources of sweetener intake were beverages and table powder. About 70% of the participants, equally distributed across all age groups, read the manufacturer's specifications of the food products' content. The estimated intakes showed that neither men nor women exceeded the ADI for acesulfame-K; however, using worst-case calculations, high intakes were found in young children (169% of ADI). In general, the aspartame intake was low. Children had the highest estimated (worst case) intake of cyclamate (317% of ADI). Children's estimated intake of saccharin only slightly exceeded the ADI at the 5% level for fruit syrup. Children had an unexpected high intake of tabletop sweeteners, which, in Sweden, is normally based on cyclamate. The study was performed during two winter months when it can be assumed that the intake of sweeteners was lower as compared with during warm, summer months. Thus, the present study probably underestimates the average intake on a yearly basis. However, our worst-case calculations based on maximum permitted levels were performed on each individual sweetener, although exposure is probably relatively evenly distributed among all sweeteners, except for cyclamate containing table sweeteners.     

Dietary intakes of six intense sweeteners by Irish adults

This research investigated the intakes of six intense sweeteners: acesulfame-K (E950), aspartame (E951), cyclamate (E952), saccharin (E954), sucralose (E955), and steviol glycosides (E960) in the diets of Irish adults, using data from the National Adult Nutrition Survey. A food label survey that included products currently available on the Irish market supplemented the analysis. Sweetener intakes were investigated using three different exposure scenarios; beginning with a crude assessment which assumed that all foods permitted to contain the additives of interest always did contain them, and at their maximum permitted level (Tier 1). Refined assessments estimated intakes of the six sweeteners using food consumption data up to brand level with additive occurrence data from a survey of products currently available on the Irish market (Tier 2) and sweetener concentration data (Tier 3). Results of all exposure assessment scenarios demonstrate that intakes of each of the sweeteners of interest by the total population were below the relevant ADI level (mg kg^?1 bodyweight^?1), even by high consumers (P99). The three sweeteners consumed in highest amounts were acesulfame-k, aspartame, and sucralose. The main sources of these sweeteners in the diet were ‘cider and perry’, ‘energy reduced and no added sugar (ER and NAS) carbonated flavoured drinks’, ‘table-top sweeteners’, ‘dairy products’, ‘solid food supplements’, and ‘sauces’. Intakes of the six intense sweeteners are currently not a concern among Irish adults. However, exposure to these chemicals should be monitored on a regular basis due to evolving market and consumption patterns.     

Dietary intake of non-nutritive sweeteners in type 1 diabetes mellitus children

The aims of the current cross-sectional study were (1) to assess the intake of aspartame, cyclamate, acesulfame-k, neohesperidine dihydrochalcone, sucralose, saccharin, steviol glycosides and neotame among children with type 1 diabetes mellitus (T1D); (2) to compare the obtained intakes with the respective acceptable daily intake (ADI) values; and (3) to conduct a scenario analysis to obtain practical guidelines for a safe consumption of non-nutritive sweeteners (NNS) among children with T1D. T1D patients of the Paediatrics Department of the University Hospitals Leuven were invited to complete a food frequency questionnaire designed to assess NNS intake using a tier 2 and tier 3 exposure assessment approach. A scenario analysis was conducted by reducing the P95 consumption of the most contributing food categories in order to reach a total sweetener intake lower than or equal to the ADI. Estimated total intakes higher than ADIs were only found for the P95 consumers only of acesulfame-k, cyclamate and steviol glycosides (tier 2 and tier 3 approach). Scenario analysis created dietary guidelines for each age category for diet soda, bread spreads and dairy drinks. There is little chance for T1D children to exceed the ADI of the different NNS, however diabetes educators and dieticians need to pay attention regarding the use of NNS.     

Intake of saccharin and cyclamate from Finnish foods between 1979 and 1985

The dietary intake of saccharin and cyclamate was investigated during the period 1979-1985 in order to find out about the use as sweeteners in the food industry and hospitals and to obtain intake data for the toxicological evaluation of sweeteners in the Finnish diet. Eighty-nine samples of desserts served in 85 hospitals were analysed in 1983. Other samples investigated were artificially sweetened commercial foods available in Finland, such as soft drinks, sweets and jellies. The intake evaluation was carried out with reference to the acceptable daily intake (ADI), with commercial portions for a child being 20 kg and for an adult 60 kg. The most important foods with regard to the intake of saccharin and cyclamate were soft drinks. In 1979, 1982 and 1985, soft drinks contributed 128%, 93%, and 51%, respectively, of the ADI of artificial sweeteners for children and 42%, 31%, and 17% for adults. Artificially sweetened desserts served in hospitals contributed to 35% of the ADI for children and 11% for adults.     

Daily intake assessment of saccharin, stevioside, D-sorbitol and aspartame from various processed foods in Korea

This study was carried out to estimate the daily intakes (EDIs) of artificial sweeteners such as saccharin, stevioside, D-sorbitol and aspartame in order to evaluate the safety of the artificial sweeteners in Korea. A total of 274 food samples were selected from the foods considered to be representative sources of artificial sweeteners in the Korean diet and analysed by using HPLC with evaporative light scattering and ultraviolet detectors. In case of aspartame, the reference values were used without instrumental analysis. The EDIs of saccharin, stevioside, D-sorbitol and aspartame for average consumers were 0.028, 0.008, 4.9 and 0.14 mg kg^-1 body weight day^-1, respectively, and as a proportion of the acceptable daily intake (ADI) were not higher than 1% of ADI of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). For 90th percentile consumers, the EDIs of saccharin, stevioside, D-sorbitol and aspartame were 2.0, 0.20, 141 and 4.6 mg kg^-1 body weight day^-1, respectively, and as a proportion of the ADI, the EDIs of saccharin and aspartame were 40.7% and 11.4% of the ADI set by the JECFA, respectively. Because JECFA did not assign ADIs for stevioside and D-sorbitol, the values for these sweeteners were not compared. According to these results, the EDIs of artificial sweeteners such as saccharin and aspartame in Korea are significantly lower than ADI set by the JECFA.     

An analysis of the incremental value of retaining brand-level information in food consumption databases in estimating food additive intake

In the Dietary and Nutritional Survey of British Adults (DNSBA) food consumption database, brand level intake data are recorded for 2197 subjects over 7 days. This study set out to examine the incremental value of such brand level data in food consumption studies to estimate additive intake. The food codes in the DNSBA database were re-arranged into 14 food categories within each of which were varying numbers of both sub-categories of foods and of brands. Intake of the 97.5th percentile for brands and sub-categories were compared with intakes at the 97.5th percentile of the appropriate food category. Taking ≥ 60 consumers as the minimal sample size for which a 97.5th percentile statistic can be calculated, only 6% of the 1363 brands listed had sufficient data to work with. Of the 14 food categories, six had a sub-category with a 97.5th percentile in excess of that of the category but none exceeded 1.3 x 97.5th percentile intake of the category. Of the 85 brands for which there were ≥ 60 consumers, only 11 had 97.5th percentile intakes in excess of that statistic for the relevant food category and none exceeded a multiple of 1.3 times the category 97.5th percentile intakes. Unless dietary surveys are very large and carried out for longer periods of time, there is little value in retaining food consumption data at brand level. If 1.3x the intake of an additive from a given food category at the 97.5th percentile does not exceed the ADI, no sub-category or brand appears to do so. This may provide a valuable technique in crude estimates of food additive intake.     

Estimated intake of intense sweeteners from non-alcoholic beverages in Denmark, 2005

In 2005 International Standards Organization. ISO 17025. 2005. General requirements for the competence of testing and calibration laboratories, Copenhagen: Danish Standard [Google Scholar], 76 out of 177 analysed samples of non-alcoholic beverages were found to contain the intense sweeteners cyclamate, acesulfame-K, aspartame, and saccharin. The content of cyclamate did not exceed the now permitted maximum level in the European Union of 250 mg l^?1 in soft drinks. The estimated intake of the sweeteners was calculated using the Danish Dietary Survey based on 3098 persons aged 1–80 years. The estimated intake with 90th percentiles of 0.7, 0.8 and 0.2 mg kg^?1 body weight day^?1 for acesulfame-K, aspartame, and saccharin, respectively, was much lower than the acceptable daily intake values of 15, 40, 7, and 2.5 mg kg^?1 body weight day^?1 for acesulfame-K, aspartame, and saccharin, respectively, and on the same level as in the similar investigation from 1999. In contrast to the 1999 investigation, the 90th percentile of the estimated cyclamate intake in 1–3 year olds with 3.7 mg kg^?1 body weight day^?1 was in 2005 lower than the acceptable daily intake of 7 mg kg^?1 body weight day^?1. However, the 99th percentile for 1–3 year olds with 7.4 mg kg^?1 body weight day^?1 still exceeded the acceptable daily intake slightly. The 90th percentile for the whole population with 0.9 mg kg^?1 body weight day^?1 was halved compared with 1999. The reduction in the European Union of the maximum permitted level for cyclamate from 400 to 250 mg l^?1 has brought the intake of cyclamate in small children down to well below the acceptable daily intake value.     

Estimated intake of benzoic and sorbic acids in Denmark

The monitoring of food additives and recent dietary surveys carried out in Denmark have earlier been used to estimate the intake of sweeteners and nitrite in relation to acceptable daily intakes. The ubiquitous use of the preservatives benzoic and sorbic acids raises the question of the magnitude of the intake of these preservatives in relation to acceptable daily intakes. This area is explored in this paper. The content of benzoic and sorbic acids in all food groups, where they are allowed, was monitored in Denmark 17 times between 2001 and 2006 with a total of 1526 samples. Transgressions of maximum limits, illegal use or declaration faults were found in about 3% of samples. From repeated investigations on fat-based foods (salads and dressings), marmalade and stewed fruit, it is concluded that the amounts used in industry have been relatively stable throughout the whole period, although limited data for marmalade show some variation. Most foods in the categories soft drinks, dressings, fat-based salads, pickled herrings, and marmalade contain benzoic and sorbic acid, and sliced bread also contains in some cases sorbic acid. The median daily intake and intake distribution of benzoic and sorbic acids were calculated with data from the Danish National Survey of Dietary Habits and Physical Activity (age from 4 to 75 years) conducted in 2000–2004 with 5785 participants. The median intakes of both benzoic acid and sorbic acid are well below the acceptable daily intakes of 0–5 and 0–25 mg kg^?1 body weight (bw) day^?1 for benzoic and sorbic acid, respectively. However, the 90th percentile based on the average of the samples with a content of benzoic acid is higher than the acceptable daily intake for both men and women, with the highest value of 16 mg kg^?1 bw day^?1 for both boys and girls in the 4–6-year-old age group. Based on the average of all samples, the 95th percentile is over the acceptable daily intake for men up to 34 years and for women up to 24 years, and the 90th percentile for men up to 18 years and for women up to 10 years. Soft drinks, salads and dressings are the main contributors to benzoic acid intake. The sorbic acid intake based on the average of all samples is well below the acceptable daily intake. However, for the intake based on the average of samples with content, the 95th percentile exceeds the acceptable daily intake. This is caused by the dominating contribution to the intake of sorbic acid from sliced bread, but since only seven out of 42 samples have added sorbic acid, the calculation based on the average of samples with content will exaggerate the intake. With a built-in safety factor of 100 in the acceptable daily intakes and judging from the literature, the high intakes of benzoic acid should not cause any concern for ill-effects. However, there must be a reason to reconsider the maximum limits especially for benzoic acid in soft drinks, dressings and salads and for sorbic acid in sliced bread.     

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.     

Assessment of Korean consumer exposure to sodium saccharin,aspartame and stevioside

The dietary intakes of sodium saccharin, aspartame and stevioside were estimated on the basis of food consumption data of the Korean consumer and the concentration of sweeteners in processed foods. Results were compared with the acceptable daily intake (ADI) of sweeteners. Among the 28 food categories for which the application of sodium saccharin, aspartame and stevioside is permitted in Korea, they were detected in 5, 12 and 13 categories, respectively. The estimated daily intake (EDI) of sodium saccharin and aspartame were high in infants and children, whereas the EDI of stevioside was high in adolescents and adults. The most highly consumed sweetener was aspartame, and the highest EDI/ADI ratio was found for sodium saccharin. The main food categories contributing to sweetener consumption were beverages, including alcoholic beverages. For most Korean consumers, the EDIs were no greater than 20% of their corresponding ADI; however, the EDI of sodium saccharin for conservative consumers aged 1–2 years reached 60% of their ADI.     

Safety evaluation of substances consumed as technical ingredients (food additives)

The different types of acceptable daily intakes (ADIs) are described as used by the FAO/WHO Expert Committee on Food Additives (JECFA) and the EEC Scientific Committee for Food (SCF). The allocation is discussed of a full ADI or a temporary ADI, and examples are given for the establishment (or withdrawal) of these ADIs. The flavours cinnamyl anthranillate and the solvent 2-nitropropane (both withdrawn), the sweeteners cyclamate and saccharin and the antioxidant BHA (all three changed) but not abolished. For BHA and saccharin the ADI was retained by both committees in spite of some evidence of carcinogenicity to experimental animals. ADI--'not specified' is specially discussed and it is recommended that numerical ADIs are used whenever possible. With an ADI--'not specified' it should be stated which use (and intake) levels are toxicologically acceptable. Some compounds evaluated by the two committees are discussed, e.g. the colours: Allura red AC, erythrosine, canthaxanthin and the caramels; three anti-oxidants: BHA, BHT and the gallates; the sweeteners: polyols, aspartame, saccharin and cyclamates. Four recommendations are made: (1) a numerical basis be given for the levels allocated an ADI--'not specified' or 'acceptable'; (2) lowering of the conventional safety factor be considered when the effects found are trivial--higher safety factors be considered when the toxic effects are serious or even irreversible; (3) ADIs should, whenever possible, be based on a combination of human and animal data; (4) ADIs might be allocated to compounds indicating animal carcinogenicity, if the compound is non-genotoxic, the mechanism clearly secondary and/or species-specific.     

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.     

Exposure assessment of synthetic colours approved in Korea

The dietary intakes of nine synthetic food colours – amaranth, erythrosine, Allura Red, Ponceau 4R, tartrazine, Sunset Yellow FCF, Fast Green FCF, Brilliant Blue FCF and indigo carmine – permitted in Korea were estimated based on food consumption data for consumers and their concentrations in processed foods. The estimated daily intakes (EDIs) by Korean consumers were compared with the acceptable daily intakes (ADIs) of the colours. Among 704 foods sampled, 471 contained synthetic colours. The most highly consumed synthetic colours were Allura Red and tartrazine; the highest EDI/ADI ratios were found for amaranth, erythrosine and Allura Red. The EDIs of infants and children were higher than those of adults. The main food categories containing colours were beverages and liquor for adults, and beverages, chocolate and ice cream for infants and children. For average Korean consumers, the EDIs were not greater than 2.5% of their corresponding ADIs, although the EDI of a conservative consumer in the upper 95th percentile reached 37% of the ADI.