Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of  
Steviol Glycosides from Stevia rebaudiana  Bertoni as a Sweetener   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Permitted 
Sweeteners to Enable the Use of Steviol 
Glycosides from Stevia rebaudiana Bertoni  as a 
Sweetener  
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: [NO M/ADM-0102] 
August 30, 2017  
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of  
Steviol Glycosides from Stevia rebaudiana  Bertoni as a Sweetener   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    2 Summary  
 
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by the 
Minister of Health and the Food and Drug Regulations  (Regulations) .  Approved food additives 
and their permitted conditions of use are set out in the Lists of Permitted Food Additives  that are 
incorporated by reference in the MAs and published on Health Canada’s website.  A petitioner can request that Health Canada approve a new additive or a new condition of use for an already approved food additive by filing a food additive submission with the Department's Food Directorate.  Health Canada uses this premarket approval process to determine whether the scientific data support the safety of food addit ives when used under specified conditions in foods 
sold in Canada. 
 Steviol glycosides
1 is a food additive that may be used as a sweetener in the foods and at the 
maximum levels set out in item S.1.2 of the List of Permitted Sweeteners .  Canada has permitted 
steviol glycosides from the stevia plant ( Stevia rebaudiana Bertoni) to comprise one or more of 
ten named steviol  glycosides, singly or in any combination, provided that the total steviol 
glycosides content is at least 95%.  The ten steviol glycosides are stevioside, rebaudioside A, rebaudioside B, rebaudioside C, rebaudioside D, rebaudioside F, rebaudioside M, dulcoside A, rubusoside, and steviolbioside.  
 Health Canada received a food additive submission requesting that the permitted steviol glycosides content of this sweetener be expanded to include all the steviol glycosides in the Stevia rebaudiana Bertoni plant.   Health Canada’s evaluation of available scientific data support s this change .  Consequently, the 
List of Permitted Sweeteners  has been modified by removing the names of the ten steviol 
glycosides from the entry in column 1 of item S.1.2 of the  List and by adding the name of the 
plant  source of the steviol glycosides to this entry, as shown in the table below.  
 
Modification to the  List of Permitted Sweeteners  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or U pon Column 3  
Maximum Level of Use and 
Other Conditions  
S.1.2  Steviol glycosides 
from Stevia 
rebaudiana 
Bertoni  (1) Table -top sweeteners  (1) Good Manufacturing Practice  
(2) … (9)  (2) … (9)  
 
 
 
                                              
1 When referring to the name of the additive the term “steviol  glycosides” is used in the singular.   
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of  
Steviol Glycosides from Stevia rebaudiana  Bertoni as a Sweetener   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment  to expand the 
permitted composition of the sweetener steviol glycosides  to include  any of t he steviol 
glycosides from the Stevia rebaudiana Bertoni  plant  in any combination.  No change in the 
minimum steviol glycosides content of the sweetener ( i.e., not less than 95% of the total of 
steviol glycosides on the dried basis ) was requested .  
 
Steviol glycosides share a common chemical structure of steviol with  a sugar moiety attached at 
one or both of two specific positions , and from the available information  they are al l expected to 
be fermented  by intestinal bacteria to steviol  and o ne or more sugars . On the basis of this  
common structure  and metabolism  the safety assessment did not identify any toxicological food 
safety concerns  with  permitting the sweetener steviol  glycosides to comprise any of the steviol 
glycosides from the Stevia rebaudiana Bertoni plant .  The safety assessment also did not identify 
any chemical, microbiological, or nutritional food safety concerns.   
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as steviol glycosides from 
Stevia rebaudiana Bertoni  that do not have food- grade specifications set out in Part B of the 
Regulations meet the most recent food -grade specifications set out in the Food Chemicals Codex  
or the Combined Compendium of Food Additive Specifications .  The Food Chemicals Codex  is a 
compendium of standards for purity and identity for food ingredients, including food additives, 
published by the United States Pharmacopeial Convention.  The Combined Compendium of Food Additive Specifications , which contains specifications  prepared by the Joint FAO/WHO Expert 
Committee on Food Additives ( JECFA ), is published by the Food and Agriculture Organization 
of the United Nations  (FAO)  on the organizati on’s website . 
 In the List of Permitted Sweeteners
, the maximum level of use for steviol glycosides is expressed 
as ‘steviol equivalent s’ as there may be numerous steviol glycoside compounds of varying 
molecular weights and concentrations  extracted f rom the Stevia rebaudiana Bertoni plant .  The 
molecular weights of the various steviol glycosides are different, but they all share the same general steviol chemical structure.  Steviol is the reference compound and therefore the weight or concentration of steviol glycosides can be expressed on the basis of steviol content .  The most 
common and abundant steviol glycosides  in the stevia plant ( Stevia rebaudiana Bertoni)  are 
listed in T able 1 below .  Conversion fac tors for each of these steviol glycoside s are derived by 
calculating the ratio of the molecular weight of steviol to the molecular weight of the steviol glycoside of interest .  Conversion is achieved for a particular steviol glycosides preparation using 
the fac tors for converting steviol glycosides to steviol equiva lents shown in T able 1 below and 
the proportions of each steviol glycoside in the preparation of interest.  For the other minor steviol glycosides compounds , which are captured in T able 1 as “all other steviol glycosides”, 
the conversion factor is estimated to be 0.33, which is the median conversion factor for all of the major identified steviol glycosides .  As the  concentrations of the minor steviol glycosides in a  
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of  
Steviol Glycosides from Stevia rebaudiana  Bertoni as a Sweetener   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 steviol glycoside prepar ation are expected to be very low  (typically no more than 5% of the total 
steviol glycosides content), th is value  is considered to be  a conservative approximation.  
 
Table 1.  Factors for converting steviol glycosides to steviol equivalents  
 
Steviol  Glycoside Molecular Weighta (MW; g/mol ) Conversion Factorb 
Rebaudioside A  967.0  0.33 
Rebaudioside B  804.9  0.40 
Rebaudioside C  951.0  0.33 
Rebaudioside D  1129.2  0.28 
Rebaudioside E  967.0  0.33 
Rebaudioside F  937.0  0.34 
Rebaudioside M  1291.3  0.25 
Rebaudioside N  1275.3  0.25 
Rebaudioside O  1437.4  0.22 
Rubusoside  642.7  0.50 
Steviolbioside  642.7  0.50 
Dulcoside A  788.9  0.40 
Stevioside  804.9  0.40 
All other steviol glycosides  - 0.33 
a Steviol is the reference molecule with a MW  of 318.45  g/mol.  
b Conversion factor = MW steviol ÷ MW steviol glycosides .  
 
Implementation and Enforcement  
 
The above modification came into force  August 3 0, 2017, the day it was published in the  List of 
Permitted Sweet eners. 
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.   
Contact Information  
Health Canada's Food Directorate is committed to reviewing any new scientific information on the safety in use of any food additive, including steviol glycosides from Stevia rebaudiana Bertoni .  Anyone wishing to submit new scientific information on the use of this additive or to 
submit any inquiries may do so in writing, by regular mail or electronically.   If you wish to 
contact the Food Directorate electronically, please use the words " Steviol glycosides from 
Stevia rebaudiana Bertoni " in the subject line of your e -mail.  
 Bureau of Chemical Safety, Food Directorate
 
251 Sir Frederick Banting Driveway  
Tunney’s Pasture , PL: 2202C   
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of  
Steviol Glycosides from Stevia rebaudiana  Bertoni as a Sweetener   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    5 Ottawa, Ontario K1A 0L2  
E-mail: bcs -bipc@hc -sc.gc.ca