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Food and Nutrition

Information and Consultation Document on Health Canada's Proposal to Allow the Use of the Food Additive Steviol Glycosides as a Table-Top Sweetener and as a Sweetener in Certain Food Categories

Notice to the reader: The online consultation is now closed.

As a result of this process, a modification was made to the List of Permitted Sweeteners to enable the use of steviol gylcosides as a table-top sweetener and as a sweetener in certain food categories on November 30, 2012. The proposed use of this food additive in Canada as described is now enabled.

For more information on this initiative, please contact the Bureau of Chemical Safety's Chemical Health Hazard Assessment Division at bcs-bipc@hc-sc.gc.ca.

July 2012
Bureau of Chemical Safety, Food Directorate

Table of Contents

Purpose

This document outlines the assessment completed by Health Canada's Food Directorate of the food additive steviol gylcosides for use as a table-top sweetener and as a sweetener in certain food categories. Since no safety concerns have been raised through this assessment, the department is proposing to authorize the use of the food additive as described in this document. Health Canada is seeking comments on this proposed action.

Background

In Canada, all food additives are regulated and subject to rigorous controls under the Food and Drugs Act and the Food and Drug Regulations (Regulations). Before a food additive is permitted for use, a submission must be filed with Health Canada's Food Directorate so the Department can conduct a thorough safety evaluation of the proposed use(s) of the additive. Food manufacturers are not permitted to use an additive in foods to be sold in Canada until it has been approved by Health Canada and steps have been taken to legally enable its use. Health Canada considers the concentrated and purified mixture of steviol glycosides extracted from the leaves of the plant Stevia rebaudiana Bertoni of the family Asteraceae, to be a food additive. Steviol glycosides possess a sweet taste, accompanied by a slight bitter note. The sweetness of steviol glycosides is approximately 200 to 300 times that of sucrose. Steviol glycosides can be used in conjunction with sugar or other sweeteners and could replace some, or all, of the various sweeteners now used in certain applications. Steviol glycosides is not currently permitted for use as a food additive in Canada.

Health Canada has received three separate submissions requesting the use of the food additive steviol glycosides as a sweetener. While one submission only requested the use of steviol glycosides in table-top sweeteners, the other two have requested that steviol glycosides be permitted for use in a variety of unstandardized foods at the maximum levels of use shown in Table 2 of Appendix A. These unstandardized foods include: table-top sweeteners; breakfast cereals; beverage mixes; unstandardized beverages mixes; unstandardized beverage concentrates; unstandardized dessert mixes; fillings; fillings mixes; toppings; topping mixes; unstandardized desserts; yogurt; breath freshener products; chewing gum; unstandardized fruit spreads; unstandardized pures and sauces; unstandardized table syrup; peanut spreads; nut spreads; unstandardized salad dressings; unstandardized condiments; confectionery glazes for snack foods; sweetened seasonings or coating mixes for snack foods; unstandardized confectionery; unstandardized confectionery coatings; and unstandardized bakery products and baking mixes. These maximum levels of use generally correspond to the levels currently permitted for steviol glycosides under the Codex Alimentarius Commission's General Standard for Food Additives (GSFA).

Health Canada's Assessment of Steviol Glycosides

Scientists within Health Canada's Food Directorate have completed a detailed evaluation of the three submissions requesting the use of steviol glycosides as a sweetener. The evaluation was focused on safety and efficacy, and considered the chemical, micobiological, toxicological, and nutritional aspects of the proposed uses of steviol glycosides as a food additive. This assessment is further described in the following sections.

It should be noted that steviol glycosides are often expressed as "steviol equivalents". The molecular weights of the various glycosides are different, but they all share the same general steviol chemical structure. Therefore, the weight or concentration of steviol glycosides can be expressed on the basis of steviol content. Conversion is achieved for a particular steviol glycosides preparation using the factors for converting steviol glycosides to steviol equivalents shown in Table 1 of Appendix A and the proportions of each steviol glycoside in the preparation of interest. For example, the amount of rebaudioside A can be multiplied by 0.33 to obtain the corresponding amount of steviol. For the Codex GSFA provisions, a conversion factor of 0.37 was used to convert to steviol equivalents from steviol glycosides.

Chemical Assessment

Product Development / Formulation

Steviol glycosides is manufactured as an off-white to white powder with a slight, characteristic odour. The powder is freely soluble in water and ethanol and has a pH between 4.5 and 7.0. Glycoside structures are comprised of glycones (sugar molecules) bound to an aglycone (non-sugar moeity). For steviol glycosides, the aglycone backbone is always steviol and the sugars bound to steviol are generally glucose, but may also be xylose or rhamnose. Therefore, the various steviol glycosides are distinguished based on the type and number of sugar units bound at two positions on the steviol backbone.

The precise composition of S. rebaudiana extracts depends upon the composition of the harvested leaves, which, in turn, are influenced by soil, climate, and the manufacturing process. While there are some differences in the production of steviol glycosides (purified stevia extract) among different manufacturers, overall, the process involves hot-water extraction of crushed stevia leaves followed by isolation and step-wise purification using alcohol solvents (methanol and/or aqueous ethanol) and ion-exchange resins. Further recrystallization and separation steps are required to obtain a final product with a high rebaudioside A, or high rebaudioside A and stevioside content. Although the relative proportions of the individual steviol glycosides may vary depending on extraction methods, the composition of the purified extract that is recognised as a food additive contains a minimum of 95% of the nine known steviol glycosides listed in Table 3 of Appendix A. The remaining 5% of the purified extract is expected to comprise non-glycosidic components, including saccharides other than those associated with the nine named steviol glycosides.

All manufacturing processes presented in the submissions were indicated by the petitioners to have been conducted in compliance with good manufacturing practices.

Specifications

A monograph on rebaudioside A (≥95%) is available in the most recent edition of the Food Chemicals Codex (FCC) (7th Edition, 2010). While there is no FCC monograph for steviol glycosides in general, the Joint World Health Organization (WHO) / Food and Agriculture Organization (FAO) Expert Committee on Food Additives (JECFA) has adopted
Next link will take you to another Web site specifications for "steviol glycosides" which were updated at its 73rd meeting in June 2010. Stevioside and rebaudioside A have been identified as the principal sweetening glycosides in steviol glycosides, along with seven other glycosides: rebaudioside C, dulcoside A, rubusoside, steviolbioside, rebaudioside B, rebaudioside D, and rebaudioside F. The sum of these nine glycosides should be at levels at a minimum of 95% of the steviol glycosides preparation.

All three petitioners have indicated and provided information demonstrating that their purified stevia extract preparations meet the relevant JECFA specifications.

Stability

The stability of steviol glycosides has been studied in various food matrices and under normal processing and storage conditions. In addition, several studies have also evaluated the stability of the product under a range of pH and temperatures. These studies allowed for the isolation and characterization of all degradation products. Studies were also conducted in a number of different food matrices (table-top formulations, mock beverages, yogurt, and white cake) to determine whether steviol glycosides remain stable in foods and beverages following processing and at a range of pH values consistent with the pH values of food in which it is proposed for use. For example, steviol glycosides demonstrated an 11% loss in cola-type beverages when stored at 22°C for 4 months.

The photostability of steviol glycosides was also examined under dry and aqueous conditions. Overall, the results of these studies confirm the stability of steviol glycosides in various food matrices under normal processing and storage conditions. In general, the small losses of the steviol glycosides, if any, are expected to be largely a result of hydrolysis of one or more glycosidic groups, the principal route of steviol glycosides decomposition.

Analytical Method

Validated high pressure liquid chromatography (HPLC) methods are available for the measurement of steviol glycosides, for example, as described in the following two publications: (1) Geuns, JMC, "Analysis of Steviol glycosides: validation of the methods", pp. 59-78 in the Proceedings of the EUSTAS Stevia Symposium, June 27th 2008, KU Leuven, Belgium Ed.: Jan M.C. Geuns; and (2) Gardana, C., Scaglianti, M. and Simonetti, P., 2010, "Evaluation of steviol and its glycosides in Stevia rebaudiana leaves and commercial sweetener by ultra-high-performance liquid chromatography mass spectrometry", Journal of Chromatography A, Vol. 1217, pp. 1463-1470.

Technological Justification

As can occur with other sweeteners, steviol glycosides have a synergistic effect on taste when used in conjunction with other sweeteners. Steviol glycosides also tend to produce a sweet taste less instantly than sucrose but it lasts for a longer period. When used in association with flavours, steviol glycosides act as a flavour enhancer producing a stronger flavour or enabling the use of a smaller quantity of the flavour of interest.
The level of use of steviol glycosides is self-limiting due to its off-note flavour at higher levels.

Microbiological Assessment

JECFA has not set microbiological specifications for steviol glycosides although the preparations should follow generally accepted principles for food hygiene. Nonetheless, the petitioners provided microbial specifications for their products along with data from three production batches demonstrating that the microbial specifications can be met.

Based on its assessment of the microbiology of the final product and the manufacturing process, Health Canada's Food Directorate concluded that there were no safety issues associated with the use of purified stevia extract as a sweetener.

Toxicological Assessment

The petitioners submitted published studies from the scientific literature in order to support the safety of this product. The studies examined a wide-range of toxicological endpoints, and were considered to form a comprehensive database. For this reason, the biological and toxicological data submitted were sufficient for Health Canada to establish an Acceptable Daily Intake (ADI) for steviol glycosides of 4 mg steviol equivalents/kg of body weight (bw).

The nine steviol glycosides, as listed in Table 1 of Appendix A are closely related structural analogues. They all contain a common backbone called steviol. For example, the only difference between rebaudioside A and stevioside is that rebaudioside A has one additional glucose molecule attached to its steviol backbone. The steviol glycosides are all metabolized and excreted by similar pathways in both rats and humans. Because of the similarity in the metabolism of the different steviol glycosides, they are expected to produce similar physiological effects. Therefore, it is considered that the results of toxicological studies on any of these compounds are applicable for the safety assessment of steviol glycosides in general.

Experiments conducted in both animals and humans have determined that steviol is the common metabolite for both rebaudioside A and stevioside. After 96 hours following oral exposure, approximately 90-100% of ingested steviol glycosides is excreted and no accumulation of steviol glycosides derivatives occurs in the body. Aside from steviol glucuronide, no other derivative was detected in the urine of humans who had ingested steviol glycosides.

When administered as a single oral dose of test material containing >95% steviol glycosides to mice, rats or hamsters, steviol glycosides demonstrated a low acute toxicity. The median lethal dose (LD50) values were up to 15 g/kg bw, which is almost three times higher than the LD50 for citric acid, an additive that is well established as safe. In addition, no toxicologically significant effects were observed in rats following dietary exposure to rebaudioside A or stevioside in short term studies (up to 90 days) with maximum doses of 4645 and 3026 mg/kg bw/day, respectively (approximately 1533 and 1210 mg steviol equivalents/kg bw/day, respectively). A six-month dietary study of rebaudioside A in dogs at dose levels up to 2000 mg/kg bw/day (approximately 660 mg steviol equivalents/kg bw/day) was also not associated with any systemic toxicity.
Three long-term studies showed no evidence of toxicity or carcinogenicity in rats exposed orally to stevioside at doses ranging from 550 to 970 stevioside mg/kg bw/day. Using the results from one of these studies, a No Observed Effect Level (NOEL) of 970 mg stevioside/kg bw/day for chronic toxicity/carcinogenicity was established (corresponding to approximately 388 mg steviol equivalents/kg bw/day).

Overall, numerous in vitro or in vivo mutagenicity and genotoxicity studies indicated that neither rebaudioside A nor stevioside were mutagenic or genotoxic. While it was noted that steviol and some of its oxidative derivatives did show clear evidence of genotoxicity in vitro, particularly in the presence of metabolic activation, in vivo assessments of DNA damage through micronucleus formation in rats, mice and hamsters showed no expression of genotoxicity in vivo at doses of up to 8000 mg steviol/kg bw. The in vivo test results using steviol as the test substance were considered more relevant in terms of assessing whether steviol glycosides pose a genotoxic hazard, and the results are consistent with the negative findings in the long-term studies.
A series of studies in rats, hamsters and rabbits demonstrated that purified stevia extract and highly purified (> 95%) stevioside and rebaudioside A did not cause reproductive toxicity and did not cause teratogenic (developmental) effects at dose levels up to 2273 (rebaudioside A) or 2500 (stevioside) mg/kg bw/day (approximately 750 and 1000 mg steviol equivalents/kg bw/day, respectively).

Results from clinical studies showed that oral intake of stevioside did not produce adverse effects on blood pressure or blood glucose in healthy individuals with normal glucose tolerance or type 2 diabetes mellitus following short term and extended periods of exposure (from 3 months up to 2 years) at dose levels up to 1500 mg/day (corresponding to approximately 7.6 mg steviol equivalents/kg bw/day for a 65-kg person). The exposure was well tolerated and no adverse effects in clinical chemistry, haematology, or urinalysis parameters were reported.
The ADI of 4 mg steviol equivalents/kg bw was established by Health Canada's Food Directorate based on the results of a long-term/carcinogenicity study in rats with a NOEL of 970 mg stevioside/kg bw/day, corresponding to approximately 388 mg steviol equivalents/kg bw/day, and an uncertainty (safety) factor of 100 to account for interspecies and intraspecies differences.
Scientists in Health Canada's Food Directorate identified no toxicological concerns with the use of steviol glycosides and consider it safe for consumption in foods by the general population, including pregnant women and children, as well as individuals with diabetes, at dose levels not greater than 4 mg/kg bw/day, expressed as steviol equivalents. This value is consistent with that derived by JECFA.

Allergenicity Assessment

No allergic reactions after consumption of stevioside as a natural sweetener were reported in the scientific literature prior to the mid-2000s. In 2007, anaphylactic-like reactions associated with stevioside in children with atopic eczema were reported by H. Kimata (2007. Anaphylaxis by stevioside in infants with atopic eczema. Allergy 62, 565-566). However, the data provided in this article were very limited and, notably, did not provide any individual histories of food allergies for the groups of children tested for hypersensitivity to stevioside or Stevia leaves. In addition, the purity of the extracts used in this study was far from that of standards usually used for allergy risk assessment.

Of note is the 2010 publication by the European Food Safety Authority (EFSA) of its opinion on the safety of steviol glycosides for the proposed uses as a food additive, in which it explained that "it is unlikely that the steviol glycosides under evaluation should cause, by themselves, allergic reactions when consumed in foods" (EFSA's Scientific Opinion on the safety of steviol glycosides for the proposed uses as a food additive, EFSA Journal 2010, 8(4), 1537). Moreover, other stevia products such as Stevia leaves or stevioside have a long history of safe use throughout the world, with no other published reports of allergic reactions in either healthy or allergic populations.

With respect to allergenicity, Health Canada's Food Directorate considers that highly purified steviol glycosides, including purified preparations of rebaudioside A, used as a food additive are unlikely to be an allergenic concern for the general population.

Nutritional Assessment

Health Canada's Food Directorate conducted a nutritional assessment of the submissions and identified no concerns from a nutritional perspective with respect to the use, as proposed, of steviol glycosides in those foods and under the conditions of use proposed.

Dietary Exposure

Table-top sweeteners

Intake estimates for steviol glycoside were provided in one submission based on the proposed use in table-top sweeteners in conjunction with food consumption data from the Canadian Community Health Survey (CCHS), Cycle 2.2. The daily intake of steviol equivalents by the general Canadian population was estimated to be 0.01 mg/kg bw/day and 0.2 mg/kg bw/day for mean all-person and mean all-user (eaters-only), respectively. The 90th percentile all-user intake of steviol equivalents from table-top sweeteners was estimated to be 0.3 mg/kg bw/day. The intake estimates were considered acceptable by Health Canada's Food Directorate.
The highest estimated 90th percentile all-user (eaters-only) intake was determined to be in children (age 3-11 years): 1.3 mg steviol equivalents/kg bw/day. However, this intake was estimated by doubling the mean intake value for this age group because sweetener consumption values from the CCHS were not released by Statistics Canada due to the small sample size (N<5).

Various food categories

Health Canada's Food Directorate conducted an exposure assessment using 24-hour food intake recall data from the Canadian Community Health Survey (CCHS) cycle 2.2. Usual intakes were calculated using the CCHS intake data along with the proposed maximum levels of use for each of the requested food categories (see Table 2: Health Canada's Proposed Conditions of Use for Steviol Glycosides as a Food Additive). These levels of use generally correspond with the Codex Alimentarius' adopted and proposed levels of use for steviol glycosides (a level of 0.1% was used for "confectionary glazes and sweetened seasonings", a food category for which Codex does not have a steviol glycosides provision, either adopted or proposed). The levels of use were evaluated from a safety perspective by comparing the modeled usual daily intakes of steviol equivalents in a population of consistent eaters of foods containing steviol glycosides at a maximum permitted level, to an acceptable daily intake (ADI) of 4 mg steviol equivalents/kg bw.

Steviol equivalents intakes were modeled under the very conservative assumption of widespread use in all requested food categories at the maximum requested levels of use in all foods. This approach yielded median intakes for all age and sex groups that are well within the ADI. Median usual intakes ranged from 0.47 steviol equivalents/kg bw/day (≥71 year old males) to 2.09 steviol equivalents/kg bw/day (4-8 year olds, male and female).

The full distribution of usual intakes, which were based on an exposure scenario where there would be consistent consumption of foods containing steviol glycosides at the maximum levels of use, showed some high percentile intakes that exceeded the ADI by a small margin, namely among children 1-3 and 4-8 years old, where the 95th percentile intakes were 4.24 mg/kg bw/day and 4.10 mg/kg bw/day, respectively. Considering individual food categories, only for the food category "beverages, mixes and concentrates" was there an intake that exceeded the ADI by a small amount among a small portion of the population, with a 99th percentile intake of 4.85 mg/kg bw/day among 1-3 years olds. This occurred only among a small percentage of specific age groups and therefore, was considered insignificant from a health perspective.

Steviol glycosides are permitted in Canada as medicinal and as non-medicinal ingredients in Natural Health Products (NHPs), as long as the dosages do not exceed 4 mg steviol equivalents/kg bw/day, consistent with JECFA's ADI. The majority of licensed NHPs, based on Health Canada's NHP database, are multi-vitamin supplements, powdered beverages, or fruit-based drinks. All these categories, except for multi-vitamin supplements, were included in the exposure assessment. Therefore, it is considered that potential exposure to steviol glycosides from NHPs is accounted for in the current estimates.

Exposure Conclusion

Based on the usual daily intake assessment performed by Health Canada's Food Directorate using food intakes from the Canadian Community Health Survey (CCHS) cycle 2.2, it was demonstrated that the petitioners' proposed levels of use, which are consistent with those adopted or proposed under the Codex Alimentarius, would result in intakes of steviol equivalents among all age categories that are generally below the ADI for steviol glycosides, expressed as steviol equivalents, established by the Food Directorate. The few examples of intakes in excess of the ADI were only among a small percentage of individuals in specific age groups at the higher levels of food consumption. These intakes were considered insignificant from a health perspective.

The exposure assessment is considered conservative insofar as it was assumed that all of the foods that could contain steviol glycosides would, and at the proposed maximum levels of use. It is recognized that due to the off-note flavour of steviol glycosides at higher levels and its cost, at least at this time, it is considered that steviol glycosides would never completely replace the use of other currently permitted sweeteners.

Of note are the results of dietary exposure estimates prepared by the Joint FAO/WHO Expert Committee on Food additives (JECFA), at its 63rd meeting in 2004. JECFA reviewed intake estimates for steviol glycosides based on per capita data assuming full replacement of sugar and honey with steviol glycosides, disappearance data, as well as estimates based on the replacement of other already approved sweeteners. JECFA estimated that steviol glycosides would likely account for 20 to 30% of total sugar replacements in foods, over time, where authorized for use. Intakes were estimated to range from 1.3 to 3.5 mg steviol equivalents/kg bw/day.

Environmental Assessment

None of the nine steviol glycosides, as shown in Table 1 of Appendix A, are substances specified on the Domestic Substances List (DSL) or the Non-Domestic Substances List (NDSL). Therefore, these substances may be subject to the New Substances Notification Regulations (Chemicals and Polymers) of the Canadian Environmental Protection Act, 1999. The petitioners have been informed of their responsibilities in this regard.

International Status

Australia and New Zealand

In August 2008, FSANZ released its Next link will take you to another Web site Final Assessment Report for Application A540 - Steviol Glycosides as Intense Sweeteners. FSANZ has adopted an ADI level of 4 mg/kg bw for steviol glycosides, expressed as steviol equivalents. Currently, FSANZ permits the use of steviol glycosides in a number of food categories at levels up to 1100 mg/kg (as steviol equivalents).

European Union

The European Union recently published legislation for the authorization of steviol glycosides for use as a sweetener at various levels in various food categories. The European Food Safety Authority (EFSA) has conducted a general safety assessment for the approval of steviol glycosides as a sweetener in foodstuffs and for use as a flavour enhancer. A positive Scientific Opinion from EFSA, setting an ADI of 4 mg/kg bw (as steviol equivalent), was published on April 14, 2010. On January 26, 2011, the EFSA published a document called "Revised exposure assessment for steviol glycosides for the proposed uses as a food additive".Footnote 6

United States

In the United States, 22 GRAS (Generally Recognized As Safe) notices (i.e.: GRN 000252, 000253, 000275, 000278, 000282, 000287, 000303, 000304, 000318, 000323, 000329, 000348, 000349, 000354, 000365, 000367, 000369, 000380, 000388, 000389, 000393, 000395) for highly-purified steviol glycosides have been submitted to the Food and Drug Administration (FDA) for review since May 2008. The US FDA has raised no objections regarding the petitioners' determinations of GRAS status of the steviol glycoside products for use as a table-top sweetener, and as a general-purpose sweetener in foods, excluding meat and poultry products and infant formulas, at levels determined by GMP.

Codex Alimentarius

During its latest review in 2008 of the safety of steviol glycosides, JECFA established a full ADI of 4 mg/kg bw, expressed as steviol equivalents, for steviol glycosides. The Codex General Standard for Food Additives (GSFA) now has provisions for the use of steviol glycosides in a wide variety of food categories at various levels of use. The Codex Committee on Food Additives is also considering new provisions for additional food categories.

Other countries

According to the petitioners, steviol glycosides are accepted for food use in various countries including Brazil (since 1986), Mexico (since 2009), Japan (since 1970), and China (since 1984).

Recommendations

Health Canada has completed a safety assessment of all relevant information, including information provided in support of the proposed use of steviol glycosides as described in three food additive submissions, and determined that there are no health or safety concerns associated with the use of steviol glycosides in the prescribed applications. Furthermore, the Department has determined that the petitioners have satisfactorily met the requirements for a food additive submission outlined in Section B.16.002 of the Regulations.

Therefore, it is proposed that steviol glycosides be legally enabled in the areas of use and at corresponding levels as detailed below in Table 2 of Appendix A.

Comments

Comments on this proposal may be submitted in writing, either electronically or by regular mail. If you are submitting your comments electronically, please use the words "steviol glycosides" in the subject box of your e-mail. Comments must be received by 11:59 p.m. EST, October 14, 2012.

Mailing Address:
251 Sir Frederick Banting Driveway
Tunney's Pasture, Ottawa Ontario, K1A 0L2
PL: 2203B

E-mail address: bcs-bipc@hc-sc.gc.ca

Additional Information

www.healthcanada.gc.ca/foodadditives

Appendix A

Table 1: Factors for converting steviol glycosides to steviol equivalents.
Steviol Glycoside Molecular
weight
Multiply steviol glycoside concentration by
factor to obtain steviol equivalents
Stevioside 804.88 0.395
Rebaudioside A 967.03 0.329
Rebaudioside C 951.02 0.334
Dulcoside A 788.88 0.403
Rubusoside 642.73 0.496
Steviolbioside 642.73 0.496
Rebaudioside B 804.88 0.395
Rebaudioside D 1129.15 0.282
Rebaudioside F 936.99 0.339
Table 2: Health Canada's Proposed Conditions of Use for Steviol Glycosides as a Food Additive.
Additive Permitted in or on Maximum Level of Use
  • Note: The units for the maximum level of use are expressed on the basis of steviol equivalents rather than steviol glycosides, which is consistent with the approach used internationally.
Steviol glycosides (1) Table-top sweeteners (1) Good Manufacturing Practice
(2) Breakfast cereals (2) 0.035% (calculated as steviol equivalents)
(3) Unstandardized beverages mixes; Unstandardized beverages; Unstandardized beverage concentrates (3) 0.02% (calculated as steviol equivalents) in beverages as consumed
(4) Unstandardized dessert mixes; Fillings; Filling mixes; Toppings; Topping mixes; Unstandardized desserts; Yogurt (4) 0.035% (calculated as steviol equivalents) in products as consumed
(5) Breath freshener products; Chewing gum; (5) 0.35% (calculated as steviol equivalents)
(6) Unstandardized fruit spreads; Unstandardized pures and sauces; Unstandardized table syrups (6) 0.035% (calculated as steviol equivalents)
(7) Peanut spreads; Nut spreads; Unstandardized salad dressings (7) 0.035% (calculated as steviol equivalents)
(8) Unstandardized condiments (8) 0.013% (calculated as steviol equivalents)
(9) Confectionery glazes for snack foods; Sweetened seasonings or coating mixes for snack foods (9) 0.035% (calculated as steviol equivalents)
(10) Unstandardized confectionery (except unstandardized chocolate confectionery); Unstandardized confectionery coatings (except unstandardized chocolate confectionery coatings) (10) 0.07% (calculated as steviol equivalents)
(11) Unstandardized chocolate confectionery ; Unstandardized chocolate confectionery coatings (11) 0.035% (calculated as steviol equivalents)
(12) Unstandardized bakery products; Baking mixes (12) 0.035% (calculated as steviol equivalents) in products as consumed
Table 3: Common name and chemical name of the nine steviol gylcosides that are included in the Joint FAO/WHO Expert Committee on Food Additives (JECFA) specification for "steviol glycosides".
Common name Chemical name
Rebaudioside A 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
Stevioside 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
Rebaudioside B 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid
Rebaudioside C
(Dulcoside B)
13-[(2-O-α-L-rhamnopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
Rebaudioside D 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester
Rebaudioside F 13-[(2-O-β-D-xylofurananosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
Rubusoside 13-β-D-glucopyranosyloxykaur-16-en-18-oic acid, β-D-glucopyranosyl ester
Steviolbioside 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid
Dulcoside A 13-[(2-O-α-L-rhamnopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester

Footnotes

Footnote 6

EFSA Journal 2001; 9(1):1972

Return to footnote 6 referrer