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Nutrients
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  • Review
  • Open Access

15 March 2018

Low-/No-Calorie Sweeteners: A Review of Global Intakes

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1
Intertek Scientific & Regulatory Consultancy, Farnborough, GU14 0 LX, UK
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Intertek Scientific & Regulatory Consultancy, Mississauga, ON L5N 2X7, Canada
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Intertek Scientific & Regulatory Consultancy, Beijing 100015, China
4
Intertek Scientific & Regulatory Consultancy, Tokyo 103-0012, Japan
Nutrients2018, 10(3), 357;https://doi.org/10.3390/nu10030357
This article belongs to the Special Issue Non-Nutritive Sweeteners: A Global Perspective
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Abstract

The current review examined published data on the intake of all major low-/no-calorie sweeteners—aspartame, acesulfame-K, saccharin, sucralose, cyclamate, thaumatin and steviol glycosides—globally over the last decade. The most detailed and complex exposure assessments were conducted in Europe, following a standardized approach. Japan and Korea similarly had up-to-date and regular intake data available. The data for other Asian countries, Latin America, Australia/New Zealand and global estimates, evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), while available, were shown to be more limited in terms of design. Overall, the studies conducted since 2008 raised no concerns with respect to exceedance of individual sweetener acceptable daily intake (ADIs) among the general population globally. The data identified do not suggest a shift in exposure over time, with several studies indicating a reduction in intake. However, some data suggest there may have been an increase in the numbers of consumers of low-/no-calorie-sweetened products. Future research should consider a more standardized approach to allow the monitoring of potential changes in exposure based upon events such as sugar reduction recommendations, to ensure there is no shift in intake, particularly for high-risk individuals, including diabetics and children with specific dietary requirements, and to ensure risk management decisions are based on quality intake analyses.

1. Introduction

The food and beverage industry over the last several years has been investigating ways to reduce the levels of free sugars within their products to comply with guidelines and regulations, such as those of the World Health Organisation [1], which has made a strong recommendation to reduce the level of sugar in the diet to less than 10%, and preferably as low as 5%. The drive to lower sugar intakes and the potential for sugar substitution with low-/no-calorie sweeteners has subsequently raised questions regarding the trends in the intake of these ingredients and the potential impact in relation to the respective Acceptable Daily Intakes (ADIs). To address these goals, it was considered important to assess up-to-date information on low-/no-calorie sweetener exposure within the global food supply and potential risk of exceeding safety thresholds by consumers.
At its most basic level, the examination of exposure to a substance requires two main inputs–(1) the concentration of the compound of interest in foods; and (2) consumption data for these foods. All exposure assessments require some aspect of modelling, which are based on ‘exposure scenarios’, as defined by the exposure assessors [2]. Authoritative guidelines recommend that a stepwise or tiered approach is used to examine intake, starting from worst-case, crude methods, continuing to more refined approaches only if the preceding assessment indicated a risk in relation to the toxicological level of concern [2,3]. Over recent years, exposure assessment methodologies have progressed from theoretical calculations of potential exposure (such as the Budget Method) to analyses using real-life individual-based food consumption and chemical concentration data. Notably, in the European Union (EU), the European Food Safety Authority (EFSA) recently released an updated version of the Food Additive Intakes Model template (FAIM, Version 2.0) for use as a screening tool by applicants and risk assessors [4], which utilizes individual-level consumption data for EU population groups, versus the previous publicly-available version of this tool (FAIM 1.0, 1.1 [5,6]), which was based on summary statistics.
With each additional input/level of refinement in an exposure assessment calculation, it is possible to consider more realistic patterns of intake for the cohort under examination. This should be clearly defined when developing the exposure scenario. It is essential to ensure that the results obtained are protective of all individuals in a population group. Young children (due to their higher consumption on a body weight basis), brand loyal individuals (due to a higher affinity to brands which may contain greater levels of the compound of interest) and diabetics (due to an increased dietary requirement for sugar replacers) are all groups who are likely at the upper end of exposure to additives, the latter specifically of relevance for low-/no-calorie sweeteners [3,7,8,9,10]. It is therefore essential to examine the robustness and suitability of the assessments used to ensure that they are fit-for-purpose in the context of risk assessment.
As noted above, all exposure scenarios require assumptions to be made by the assessor; as such, uncertainties are inherent. While crude methods can result in considerable overestimates in exposure, the underestimation of intake is a source of concern to risk managers, who must ensure the protection of all individuals. This is a particular consideration for refined assessments, where there is potential for underestimations of intake, for example, brand loyal individuals who may ingest products with a higher than average use level. As such, uncertainties of the exposure model should be assessed and presented alongside the final estimated results [3,11]. This component of the exposure assessment output provides risk managers with key information on the strengths, limitations, and variability of the results, which can guide risk management measures [12,13].
The most recent comprehensive global review of post-market surveillance data on intense sweetener intakes was conducted in 2008 by A.G. Renwick [9]. There is a large volume of additional studies which have been published since this time, which provide valuable information on global intake of newly permitted sweeteners (e.g., steviol glycosides), as well as additives with an established history of use (e.g., aspartame, sucralose). The aim of this paper was, therefore, to conduct a comprehensive review of the globally published exposure estimates for seven low- and no-calorie sweeteners (aspartame, acesulfame-K, saccharin, sucralose, cyclamate, thaumatin and steviol glycosides) since 2008; outlining the trends in intake on a regional basis and the methods utilized therein.

2. Materials and Methods

2.1. Selection of Intakes Assessments

In order to identify trends in the intake assessment data available globally, a comprehensive literature search was conducted in October 2017 using the electronic search tool, ProQuest Dialog™. A total of 15 databases were searched and included AdisInsight: Trials, AGRICOLA, AGRIS, Allied & Complementary Medicine™, BIOSIS® Toxicology, BIOSIS Previews®, CAB ABSTRACTS, Embase®, Foodline®: SCIENCE, FSTA®, Gale Group Health Periodicals Database, Global Health, MEDLINE®, NTIS: National Technical Information Service, and ToxFile®. The search terms used reflected the substances (aspartame; acesulfame-potassium; cyclamate; saccharin; steviol glycosides/Stevia; sucralose/Splenda; thaumatin, including synonyms, chemical names, trade names, and Chemical Abstract Service (CAS) numbers) and the outcome (acceptable daily intake (ADI); allowable daily intake; estimated daily intake; dietary exposure; consumption estimate; estimate of consumption; tolerable daily intake; intake assessment); and were not limited to the title and abstract. No restrictions with respect to language were imposed for the literature search. Additional searches were conducted using Spanish, Japanese, Korean and Chinese search engines to identify original language publications by government authorities or research groups which were not captured in the primary literature search; in a similar manner to the main literature search, there were no restrictions to the title and abstract. As Renwick [9] summarized the reported intakes of acesulfame-K, aspartame, cyclamate, saccharin, and sucralose, only studies published after 2008 for these sweeteners are presented in the current study.

2.2. Presentation of Data

Results are reported as a percentage of the ADI (%ADI) for average (mean or median) and high-level consumers for the population group examined in each study. The main conclusions reported, as well as comments and any uncertainties (assessed qualitatively, if relevant) associated with the models are also reported. The studies are organized according to data available per region (Africa, Asia, Australia/New Zealand, Europe, Latin America, North America, and global), and are listed in ascending order in Table 1, Table 2, Table 3, Table 4 and Table 5. For studies which conducted more than one assessment scenario, the %ADI is presented as a range (minimum reported value-maximum reported value), to incorporate all available intake estimates reported for the population cohort. The %ADI is presented as reported in publications, or was calculated by obtaining the quotient of the reported estimated intake (mg/kg body weight/day) from the respective ADI, and subsequently multiplying by 100%. The ADIs were based on those derived by the Joint Expert Committee on Food Additives (JECFA), except in European studies wherein estimated intakes were compared to ADIs derived by EFSA. Any exceptions to this are noted in the relevant tables. Notably, the ADIs for acesulfame-K and cyclamate derived by EFSA, of 9 and 7 mg/kg body weight/day [14,15], respectively, are more conservative than those derived by JECFA, of 15 and 11 mg/kg body weight/day [16,17], respectively. As a result, the estimated intakes of acesulfame-K and cyclamate can exceed EFSA’s ADI, but not JECFA’s ADI. An ADI for thaumatin has not been specified by EFSA or JECFA, though thaumatin has been accepted for use as a sweetener―available studies have demonstrated that thaumatin is of limited toxicity and is metabolized to innocuous products [18,19].
Table 1. Estimated Daily Intakes of Low-/No-Calorie Sweeteners in Asia.
Table 2. Estimated Daily Intakes of Low-/No-Calorie Sweeteners in Australia/New Zealand.
Table 3. Estimated Daily Intakes of Low-/No-Calorie Sweeteners in Europe.
Table 4. Estimated Daily Intakes of for Low-/No-Calorie Sweeteners in Latin America.
Table 5. Estimated Daily Intakes for Low-/No-Calorie Sweeteners Evaluated or Derived by JECFA.
In addition, the specific intake assessment inputs (i.e., food consumption, chemical concentration data and assessment method) are described for each study in Appendix A. These studies are also organized according to data available per region (Asia, Australia/New Zealand, Europe, Latin America, North America, and global).

4. Discussion

The current review has examined the most recently available published data on exposure assessments for seven of the most commonly used low-/no-calorie sweeteners globally. Other high-intensity sweeteners, such as Luo Han Guo fruit extracts, advantame and neotame have a more limited use, which precluded their inclusion in the review. The information obtained as part of this review identifies a large variation in the methodologies used and the level of detail available for individual low-/no-calorie sweeteners on a regional basis. Studies were identified which applied the full range of established assessment methodologies, from top-line assessments, to complex, detailed estimations. Cruder methods, known as ‘deterministic models’ or ‘point estimates’ which are quick to run and provide a rough estimation of exposure, allowing the identification of potential exceedances of the toxicological level of concern (e.g., Budget Method) and/or permit an examination of patterns of consumption over time (e.g., disappearance data), were generally used to guide more resource-intensive models. More refined assessments, so-called ‘distributional models’, which incorporate the full distribution of food consumption and/or chemical concentration data and more accurately reflect current patterns of intake were also identified in some regions (Europe and Asia). Given the diversity in data available by region, each jurisdiction will be discussed separately.
Article 27 of Regulation (EU) 1333/2008 requires that all EU Member States monitor population food additive intake [77]. This is likely the reason that the most detailed and up-to-date assessments globally have been conducted in Europe, following a standardized approach, recognized by the European Commission [7], with some studies incorporating further refinements, such as presence probability/occurrence data and market share information. The available assessments have, for the most-part, been conducted using nationally representative samples; data is available for at-risk consumers, such as children, diabetics and brand loyal individuals, as well as children with special dietary requirements (consumers of FSMPs). Most of the European studies identified included an uncertainty analysis in the publication, in line with EFSA recommendations [11]. The results of the European assessments generally do not indicate a concern among average or heavy-level healthy consumers of all ages in Europe under the typical conditions of use for all major low-/no-calorie sweeteners (i.e., Tier 3). More recent studies have generally indicated a reduction in intakes in various EU countries, although differences in design mean that comparisons between studies are limited and must be interpreted with caution. The only instances where intakes were noted to reach or exceed the ADI at Tier 3 were among young children with special dietary requirements (PKU and diabetes) for acesulfame-K, cyclamate and steviol glycosides. In both studies, limitations were identified by the study authors with regard to the following findings: consumption of low-/no-calorie sweeteners in PKU children was modeled using consumption data for healthy children [65,67], and the exceedence of the ADI observed in diabetic children was based on a small sample population (n = 9) [63]. While significant limitations were noted, these findings suggest that young children with specific dietary requirements may potentially exceed the ADI for the three sweeteners examined in the EU, indicating that intakes by these groups should be further evaluated. While the ADI is defined as the “amount of a food additive, expressed on a body weight basis that can be ingested daily over a lifetime without appreciable health risk” [94], it is important to remember that the ADI applies to children on the basis that toxicological protocols cover the periods of rapid growth, development and maturation. The possible exceedance of the ADI, on occasion including periods of childhood, has been empasised by JECFA in relation to the large safety factor applied within its derivation. The JECFA indicated that “because...data are extrapolated from lifetime animal studies, the ADI relates to lifetime use and provides a margin of safety large enough for toxicologists not to be concerned about short term use at exposure levels exceeding the ADI, providing the average intake over longer periods does not exceed it” [95]. As such, exceedance of the ADI, identified for children within these two studies, only during a fraction of their lifetime, may not indicate a safety concern, especially as low-/no-calorie sweeteners have a remarkably low acute toxicity potential [70,96,97,98]. The reduction in intake below the ADI at Tier 3 in most studies illustrates the importance of incorporating all available resources to identify the most representative exposure levels in population groups. In studies published prior to 2008, evaluated by Renwick [9], it was noted that the ADI for cyclamate was exceeded in a total of four studies, two conducted in the UK [99,100] and two conducted in Denmark [101,102]. However, more recent data reviewed as part of this analysis, indicated a reduction in estimated daily cyclamate intakes, including among Danish individuals [53]. This is likely due to changes in usage—specifically a reduction in the MPL [103]—and potential associated reformulations. Indeed, several studies noted a very low presence of this sweetener within the Norwegian and Irish markets [52,69].
There was also recent low-/no-calorie sweetener intake data available for Asian consumers, whereby the exposure methods applied varied according to country.
In Japan, up-to-date and regular assessments of sweetener intakes were primarily conducted by the Ministry of Health, Labour and Welfare (MHLW) using the market-based approach. The studies considered all ages of the general population above 1 year, using nationally representative dietary data, combined with analytical data for the foods consumed as part of the dietary surveys. The use of concentration data from foods consumed by the cohort is a strength of this approach as it results in exposure estimates that are specific to the cohort. There were no high percentile estimates examined for the Japanese population, nor investigations of consumption by diabetic individuals, and the analyses generally considered all analytical data (i.e., included foods not identified as containing sweeteners). Nonetheless, the estimated intakes were extremely low in all studies for each of the sweeteners investigated (<1%ADI), with no change in intakes identified between 2009 and 2016, suggesting that there is no safety concern, even for individuals at the upper end of exposure.
The Korean studies available were also up-to-date and examined exposure to an array of low-/no-calorie sweeteners using both deterministic and distributional approaches. The assessments were based on nationally representative dietary surveys, considering all ages of the general population, and current analytical data. One study [34] examined a scenario which was identified by the authors to be representative of consumers who were brand loyal to sweetener-containing foods, using the mean concentration of only positive samples. This is different to the approach established in the EU to assess exposure by brand loyal consumers is based on the maximum use level for the ‘brand loyal category’ (and the mean/median typical reported use level for all other categories) [104]. There was no investigation of diabetic individuals in Korea. Overall, the data indicated no concern for the six sweeteners examined among the average and high-level consumers in the general population. An examination of trends across time in several of the studies indicated that there was a reduction in the mean and heavy-level intakes calculated for acesulfame-K, aspartame, saccharin and sucralose in more recent assessments when compared with older data.
Of the two studies identified in China, only one was based on a nationally representative sample [21]. This assessment indicated that there may be exceedances among high-level (97.5th percentile) consumers of cyclamate-containing foods; however the authors noted that the use of MPLs in broad food categories (i.e., no account of actual use levels or presence) may have led to overestimations in intakes. A separate study [20] used a tiered approach to examine exposure to cyclamate and sodium saccharin from preserved fruits only in a cohort of Chinese college students. The refined assessment, which was based on the MPL and individual-based consumption data, identified no exceedance to either sweetener; however, authors did note an exceedance of the MPL for cyclamate in measured samples, indicating that the actual intakes may be higher than those calculated (up to 21%ADI in this scenario).
The Indian cohort presented information on exposure to four sweeteners (acesulfame-K, aspartame, saccharin and sucralose) in a small cohort of high-consuming individuals [22]. The assessment was based on the MPL or reported use levels for table-top sweeteners. The intakes were examined as means only, which were well below the ADI. Given the cohort examined, i.e., diabetics, overweight individuals and female college studies, the estimated intakes may be representative of high consuming ‘average’ consumers in India.
The variation in the exposure assessment methods by country in Asia mean that it is difficult to make overarching conclusions for this region. A focus on nationally representative data is critical, to allow findings to be extrapolated to the wider population. The majority of studies used actual chemical concentration data, which increases the accuracy of the findings. Information on the presence data or market share information could help to further increase the accuracy of the findings. In general, the exposure analyses in Asia indicated that the sweetener intakes were low and usually below the ADI. However, there were no investigations into dietary intake amongst diabetic individuals in this region who are considered high consumers of low-/no-calorie sweeteners. The exposure profile within this sub-population should be assessed to determine the levels in relation to the ADI.
A number of studies were identified for Latin American, which reported exposure in several South American countries. The available assessments were typically conducted in small samples, which were not nationally representative, considering actual reported use levels (from branded foods). There was no account for presence or market share in the exposure assessment calculations. Nonetheless, the results available, which considered children and diabetic individuals, did not indicate a concern based on current patterns of use for six sweeteners. There were some exceedances of the ADIs for cyclamate and saccharin for children (maximum consumers only) and diabetic individuals, respectively. No assessment of intake over time was possible due to variations in the methods applied. Renwick [9] identified a single Latin American study conducted in Brazil (1990–1991). The ADIs were not exceeded for the evaluated sweeteners (aspartame, cyclamate and saccharine); however high-level consumer-only intakes were not estimated. This aligns with research identified as part of the current review. Future assessments should consider high level intakes and seek to conduct analyses for nationally representative cohorts. There were no studies identified which examined sweetener intake in Brazil or Mexico, where national consumption data are available for analysis, including the Brazilian Pesquisa de Orçamentos Familiares and Mexican ENSANUT [105,106,107,108,109]. These data are a valuable resource for adding to the available body of evidence for this region. Food consumption from the ongoing Latin American Study of Nutrition and Health/Estudio Latinoamericano de Nutrición y Salud (ELANS) will also provide a valuable resource for future assessments [110].
The only available estimates for Australian population groups were those conducted by FSANZ for steviol glycosides and acesulfame-K in response to requests to extend the use of these two sweeteners in foods. It was determined that there is no safety concern with the estimated intakes for these sweeteners based on assessments conducted using the MPLs for the sweeteners, rather than current conditions of use. Occurrence data were not considered in the assessments, however, an assumption for the percent market share uptake of steviol glycoside was utilized for non-brand loyal categories. This is similar to the approach taken by EFSA for refined assessments of food additive intake [104]. The availability of nationally representative data provides a good resource for examining exposure in this region to low-/no-calorie sweeteners for the general population in the future.
Global assessments were identified for two sweeteners, namely, steviol glycosides and cyclamate, which indicated that there was no concern associated with the proposed or permitted conditions of their use in the general population. However, the data included were typically per capita estimates from the GEMS/Food dataset and/or poundage data (steviol glycoside), or data which was quite dated (cyclamate assessment), which do not provide detailed data for individual consumers or potential at-risk groups. This intake approach is generally used as an initial screening stage for sweeteners under investigation and may be used to guide more accurate assessments.
North American assessments provided limited data, reporting only the percent consumers for the US NHANES, without specific examination into intakes among the population. The assessments available have not investigated actual daily exposure estimates, although it was observed that the proportion of the population consuming low-/no-calorie sweeteners has increased since 1999 [88,89,90]. Information from the food industry and/or analytical data would be valuable for understanding whether the increase in the percentage of consumers is associated with a change in the actual daily exposure levels by consuming individuals. A total of five North American studies (three conducted in the US and two conducted in Canada) were previously identified by Renwick [9]. The results showed that the estimated intake of sweeteners was not exceeded in any of the studies, including at-risk populations, such as healthy children, diabetic children, and diabetic adults. However, it is important that a more up-to-date assessment is conducted, based on current inclusion levels of low-/no-calorie sweeteners, to determine whether there have been changes in exposure among the (growing) consuming population.
Finally, there were no data available for any African countries. The South African NHANES was published in 2012 [111], which will allow investigation of intakes in this country. In the absence of consumption data for other African countries, screening methods would be valuable to provide top-line estimations of exposure.
The authors note that the literature search and subsequent original language searches were comprehensive; however, some data may not have been identified for some regions due to studies not being in the public domain or searches published in additional languages not considered.

5. Conclusions and Recommendations

Overall, the studies conducted to determine the exposures of low-/no-calorie sweeteners since 2008 raise no concerns with respect to exceedance of individual sweetener ADIs among the general population globally. The current data identified also do not suggest a significant shift in exposure over time, with several studies indicating a reduction in intake. While exceedances have been noted for cyclamate, acesulfame-K, steviol glycosides and saccharin in some populations, these are generally only among high-level consumers and/or specific sub-groups of the population, such as diabetics and children with special medical requirements.
The ADI was selected as an appropriate parameter to investigate potential safety concerns for low-/no-calorie sweetener intakes as this is the primary health-based guidance value used by competent authorities globally [112], and also the value used in the available intake studies identified from the literature search. Another area of concern, for which there is a growing body of research, is the potential association between low-/no-calorie sweeteners and health parameters, including weight management and obesity, cardiometabolic health, and diabetes, among other health effects. However, there is no conclusive evidence that high intakes of low-/no-calorie sweeteners are associated with these health conditions [113,114,115,116]. Nonetheless, researchers should continue to monitor the available data and consider all intake information for these additives in light of the most robust and concrete scientific literature.
There are data gaps/limitations in the information available, which vary according to region. Differences in the methods used varied not only within a country but also across regions; therefore, limited comparisons between results can be made. To address these limitations, future research should consider a more standardized approach, which will allow trends over time to be examined–an important consideration in light of changes in product formulations. Furthermore, it is important that the population groups examined are considered representative of the wider cohort for whom they represent, e.g., general population or diabetic individuals, and that the chemical concentration data used is representative of products ingested by the consuming population. While data was available for diabetic individuals, there are other subgroups of the population who may be exposed to higher than average levels of low-/no-calorie sweeteners. One such group are individuals on weight loss diets. There was very limited information (only one sample in India [22]) in regard to intake by this cohort. While this study did not suggest a concern with respect to the ADI for sweeteners examined, additional data in more regions would be necessary to make any conclusions regarding exposure within this subgroup. In terms of gathering detailed food consumption data for a population group, for which none exists, Kroes et al. [12] and EFSA [117] have reviewed the available data collections methods; the EFSA guidance document has made recommendations about dietary recall approaches for different cohorts. In countries where there are nationally representative food consumption data available, these should be combined with the best available concentration data to obtain estimates of exposure to sweeteners. With respect to chemical concentration data, information on the presence of sweeteners (as sweeteners are normally used in blends/mixtures, and technological limitations restrict use within food categories), and data on the market share (ensuring the information is representative of products being consumed) are also very valuable resources for obtaining the most accurate assessment of intakes. They may also help to guide assessments based on evaluations of patterns of use of sweeteners.
Overall, while the robustness of the data can obviously be improved in the future in various locations globally, the data provide a significant level of comfort that there does not appear to be a significant shift in low-/no-calorie sweeteners intake and levels of exposure are generally within the ADI limits for the individual sweeteners. However, it is considered important to continue to monitor potential exposures based upon events such as the recent requirement to reduce the level of sugar intake, to ensure there is no shift in intakes, particularly for high-risk individuals, such as diabetics and children with specific dietary requirements, and to ensure risk management decisions are based upon quality intake analyses.

Supplementary Materials

The following are available online at http://www.mdpi.com/2072-6643/10/3/357/s1, Table S1: Methodologies Utilized Intake Assessments Conducted Low-/No-Calorie Sweeteners in Asia; Table S2: Methodologies Utilized Intake Assessments Conducted Low-/No-Calorie Sweeteners in Australia/New Zealand; Table S3: Methodologies Utilized Intake Assessments Conducted Low-/No-Calorie Sweeteners in Europe; Table S4: Methodologies Utilized Intake Assessments Conducted Low-/No-Calorie Sweeteners in Latin America; Table S5: Methodologies Utilized Intake Assessments Evaluated or Derived by JECFA.

Acknowledgments

This work was supported by the International Sweeteners Association (ISA).

Author Contributions

D.M. identified the data to be extracted from all studies; M.D. conducted the literature search and identified additional English-language articles; H.Y.L. translated Korean studies and identified additional Korean articles; T.T. translated Chinese studies and identified additional Chinese articles, N.K. translated Japanese studies and identified additional Japanese articles; P.B. translated Spanish studies and identified additional South American articles; D.M. and M.D. analyzed the data from each study; D.M., M.D. and A.R. wrote the paper.

Conflicts of Interest

The founding sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and in the decision to publish the results.

Appendix A

Appendix A describes the studies identified in terms of the population group examined and the primary intake assessment inputs for each study. Data are presented in tabular format (Table S1 to S5), organized in ascending order for each region wherein data was identified (Asia, Australia/New Zealand, Europe, Latin America, and global).
In terms of the assessment of inputs, the specific data utilized in each study are summarized, with respect to:
  • Food consumption information;
  • Chemical concentration data; and
  • Exposure assessment method and details.
For the food consumption information, the method of recording consumption data is described. For the chemical concentration data, information is presented on the source of the chemical concentration data (i.e., regulatory limits, reported use levels and/or analytical data), and whether presence data or market share information were included in the model. Finally, the assessment model(s) used in each assessment are described as deterministic, simple distribution and/or probabilistic, with details provided as relevant. The order of the studies in these tables correspond to the tables in the current review and allow an examination of the specific methodologies used in each region as described herein.

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Chondroprotective Effects of a Standardized Extract (KBH-JP-040) from Kalopanax pictus, Hericium erinaceus, and Astragalus membranaceus in Experimentally Induced In Vitro and In Vivo Osteoarthritis Models
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