Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Rebaudioside M  
As a Sweetener in Various Unstandardized Foods   
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 Rebaudioside M as a Sweetener in 
Various Unstandardized Foods  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0065] 
 
January  15, 2016   
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Rebaudioside M  
As a Sweetener in Various Unstandardized Foods   
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.  Approved food additives and their 
permitted conditions of use are set out in the Lists of Permitted Food Ad ditives  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 su bmission with the Department's Food 
Directorate.  Health Canada uses this premarket approval process to determine whether the 
scientific data support the safety of food additives when used under specified conditions in foods 
sold in Canada.  
Health Canada r eceived a food additive submission seeking approval for the use of steviol 
glycosides containing the steviol glycoside “rebaudioside M” (Reb M) at a concentration of ≥50 
to ≥95% as a high -intensity sweetener in the same food categories and under the same c onditions 
of use as the currently -permitted steviol glycosides. The remainder of the composition of the 
steviol glycoside preparation would consist of some or all of the nine other steviol glycosides 
identified in the Food Chemical Codex  (FCC) monograph.  
 
Reb M is one of a number of steviol glycoside s that are naturally present in the stevia leaf.  
Reb M is a minor glycoside that has recently been identified in small amounts in commercial 
steviol glycoside preparations where the predominant glycoside is eit her rebaudioside A or 
stevioside. The Food Chemical Codex  (FCC) and the Joint FAO/WHO Expert Committee on 
Food Additives (JECFA) specifications  require that steviol glycosides contain no less than 95% 
of the sum of nine steviol glycosides that are identif ied in their monograph, namely stevioside, 
rebaudiosides A, B, C, D and F, dulcoside A, steviolbioside, and rubusoside. Reb M is not 
identified in either the FCC or JECFA specifications as being one of the steviol glycosides 
composing the sweetener.  
 
The results of Health Canada’s evaluation of available scientific data support the safety of the 
steviol glycoside Reb M when used as set out in the table below . Therefore, Health Canada has 
modified the List of Permitted Sweeteners  to extend the use of steviol glycoside preparations 
containing Reb M by adding the entry shown below to Column 1 of item S.1.2 of the list.   
 
Modification to the List of Permitted Sweeten ers  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and 
Other Conditions  
S.1.2  Steviol glycosides  
(One or any 
combination of 
Stevioside, (1) 
Table -top sweeteners  (1) 
Good Manufacturing Practice  
(2) 
Breakfast cereals; (2) 
0.035% (calculated as steviol  
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Rebaudioside M  
As a Sweetener in Various Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Rebaudioside A, 
Rebaudioside  B,  
Rebaudioside C, 
Rebaudioside D, 
Rebaudioside F, 
Rebaudioside M, 
Dulcoside A, 
Rubusoside, and 
Steviolbioside, such 
that the total steviol 
glycosides content is 
not less than 95%)  Confectionery glazes for 
snack foods; Nut spreads; 
Peanut spreads; Sweetened 
seasonings or coating mixes 
for snack foods; 
Unstandardized chocolate 
confectionery; 
Unstandardized chocolate 
confectionery coatings; 
Unstandardized fruit 
sprea ds; Unstandardized 
purées; Unstandardized 
salad dressings; 
Unstandardized sauces; 
Unstandardized table syrups  equivalents)  
(3) 
Unstandardized beverage 
concentrates; 
Unstandardized beverages; 
Unstandardized beverages 
mixes  (3) 
0.02% (calculated as steviol 
equivalents) in beverages as 
consumed  
(4) 
Baking mixes; Filling 
mixes; Fillings; Topping 
mixes; Toppings; 
Unstandardized bakery 
products; Unstandardized 
dessert 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 condiments  (6) 
0.013% (calculated as steviol 
equivalents)  
(7) 
Unstandardized 
confectionery (except 
unstandardized chocolate 
confectionery); 
Unstandardized 
confectionery coatings 
(except unstandardized (7) 
0.07% (calculated as steviol 
equivalents)   
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Rebaudioside M  
As a Sweetener in Various Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 chocolate confectionery 
coatings)  
(8) 
Meal replacement bars  (8) 
0.02% (calculated as steviol 
equivalents)  
 
Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of the requested 
uses of steviol glycoside preparations containing Reb M at a concentration of ≥50 to ≥95% . The 
assessment considered microbiological, toxicological, nutritional, and chemical aspects of this 
additive, and found that the requested uses are acceptable from a food safety perspective. 
Therefore, the Department has enabled the requested uses of stev iol glycoside preparations 
containing Reb M by modifying the List of Permitted Sweeteners  as described in the above table.  
 
Other Relevant Information  
 
The 47th Session of the Codex Committee on Food Additives (CCFA) submitted a request to 
JECFA via the “Priority List of Substances Proposed for Evaluation by JECFA” for a safety 
assessment and revision of specifications for steviol glycosides to (1) include rebaudi osides M 
and E, and (2) delete the requirement that the primary steviol glycosides in stevia preparations be 
stevioside and/or Reb A.1 JECFA has issued a call for data so that the request can be considered 
at the Expert Committee’s 82nd meeting in June 2016.  
 
Two “self -affirmed” GRAS notifications have been filed with the U.S. Food and Drug 
Administration (US FDA) for steviol glycosides containing Reb M as a principle component. In 
both notifications, the intended use is as a general pur pose sweetener in foods (excluding meat 
and poultry products and infant formula) at levels consistent with GMP and as a tabletop 
sweetener. The FDA had no questions at the time regarding the petitioners’ conclusions that 
under the intended conditions of us e the sweetener was GRAS.  
 
Food Standards Australia New Zealand (FSANZ) has evaluated an application seeking approval 
to use steviol glycoside preparations containing Reb M at a concentration of ≥50% to ≥95% as 
an intense sweetener. FSANZ raised no public health and safety concerns with the use of Reb M 
as a food additive in accordance with the current provisions for steviol glycosides. A new 
specification for Reb M is anticipated in mid -January 2016 in Schedule 3 of the revised Food 
Standards Code.2  
 
                                              
1 See the Report of the 47th Session of the Codex Committee on Food Additives (REP 15/FA) and the Addendum 1 
document for Agenda Item 7a of that meeting (CX/FA 15/47/16 Add.1).  
2 Call for Submissions – Application A1108, Rebaudioside M as a Steviol Glycoside Intense Sweetener, 29 June 
2015   
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Rebaudioside M  
As a Sweetener in Various Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 Steviol glycosides have been permitted to be added to foods in the European Union (EU) since 
2011.3 Although the EU’s specifications for steviol glycosides do not currently refer to Reb M as 
one of the steviol glycosides in this sweetener4, the European Food S afety Authority published, 
on December 8, 2015, its scientific opinion that extending the current specifications for steviol 
glycosides to include Reb M would not be a safety concern.5   
 
Implementation and Enforcement  
 
The above modification came into force January 15, 2016 , the day it was published in  the List 
of Permitted Sweeteners . 
 
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 containing Reb M . Anyone 
wishing to submit new scientifi c 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 Reb M ” in the subject line 
of your e -mail.  
 
Bureau of Chemical Safety , Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail:  bcs-bipc@hc -sc.gc.ca  
                                              
3 Commission Regulation (EU) No 1131/2011 of 11 November, 2011 amending Annex II to Regulation (EC) No 
1333/2008 of the European Parliament and  of the Council with regards to steviol glycosides. Off J Eur Union 54 
(L295): 205 -211 
4 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in 
Annexes II and III to Regulation (EC) No 1333/2008 of th e European Parliament and of the Council (text with EEA 
relevance). Pdf version of Official Journal of the European Union , L 83/1, 22.3.2012  
5 Scientific opinion on the safety of the proposed amendment of the specifications for steviol glycosides (E 960) a s 
a food additive, EFSA Journal 2015; 13(12): 4316.