Notice of Modification to the List of Permitted Sweeteners  to Enable th e Use of  
Steviol Glycosides from Saccharomyces cerevisiae CD15380 and CD15407  in a Vari ety of 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 U se of Steviol 
Glycosides from Saccharomyces cerevisiae 
CD15380 and CD15407  in a Variety of Foods  
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number:  NOM/ADM-0132 
May 14, 2019 Notice of Modification to the List of Permitted Sweeteners  to Enable th e Use of  
Steviol Glycosides from Saccharomyces cerevisiae CD15380 and CD15407  in a Vari ety of 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  (Regulations) . Approved food additives 
and their permitted conditions of use are set out in the Lists of Per mitted Food Additives  that are 
incorporated by reference in the MAs and published on the Canada.ca  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 additives when used under specified conditions in foods 
sold in Canada.  
 
Health Canada ’s Food Directorate  received  a food additive submission seeking approval for the  
use of steviol glycoside s from 2 genetically modified strains of Saccharomyces cerevisiae , S. 
cerevisiae CD15380 and S. cerevisiae CD15407,  in all foods where steviol glycosides from 
Stevia rebaudiana Bertoni is permitted and at the same maximum levels of use.  
 
Steviol glycosides1 from Stevia rebaudiana  Bertoni is already permitted for use in Canada as a 
sweetener  in a variety of  standardized and unstandardized foods .   
 
The results of the Food Directorate ’s evaluation of available scientific data support  the safety of 
steviol g lycosides  from S. cerevisiae CD15380 and S. cerevisiae CD15407  when used as set out 
in the table below . Therefore, Health Canada has modified the List of Permitted Sweeteners  to 
enable  the us e of steviol glycosides  from S. cerevisiae CD15380 and S. cerevisiae  CD15407  by 
adding the name of these sources in column 1 of item no. S.1.2 as  shown below  in the list . 
 
Modification to the List of Permitted Sweeteners  
 
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 from :  
Stevia rebaudiana  
Bertoni ;  
Saccharomyces cerevis iae 
CD15380 ; Saccharomyces 
cerevisiae  CD15407  (1) Table -top sweeteners  
 (1) Good Manufacturing 
Practice  
 
… … 
(10) Canned (naming the 
fruit); Unstandardized 
canned fruit  (10) 0.012 % (calculated as 
steviol equivalents)  
 
 
 
                                              
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 th e Use of  
Steviol Glycosides from Saccharomyces cerevisiae CD15380 and CD15407  in a Vari ety of Foods   
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 of the requested 
uses of steviol glycosides from Saccharomyces cerevisiae CD15380 and CD15407 . The 
assessment concluded that information related to  chemi stry, microbiology, molecular biology, 
nutrition  and toxicolog y supports the safety of  steviol glycosides f or its  requested use s. 
Therefore, the Department has enabled the reque sted steviol glycoside s from S. cerevisiae 
CD15380 and CD15407  by modifying the List of Permitted Sweeteners  as shown  in the above 
table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as steviol glycosides that do not 
have specifications set out in Part B of the Regulations meet the most recent 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 b y the Joint FAO/WHO Expert Committee on Food Additives (JECFA), is published 
by the Food and Agriculture Organization of the United Nations. Specifications for steviol 
glycosides from S. cerevisiae CD15380 and CD15407 were not set out in either of these so urces 
at the time of publication of this Notice of Modification. Until such time that a specification is 
established within the FCC or by JECFA, steviol glycosides from S. cerevisiae  CD15380 and 
CD15407 that meets the manufacturer’s in -house specifications2 as presented to Health Canada 
are considered acceptable.   
 
Implementation and Enforcement  
 
The above modification came into force May 14, 2019 , 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  from Saccharomyces 
                                              
2 The petitioner indicated that all raw materials, food processing aids and equipment used in the production of the 
steviol glycosides are food -grade qualit y, and methods used to purify the product are consistent with those 
outilined in the Chemical and Technical Assessment (CTA) published by FAO/JECFA for steviol glycosides from S. 
rebaudiana . Notice of Modification to the List of Permitted Sweeteners  to Enable th e Use of  
Steviol Glycosides from Saccharomyces cerevisiae CD15380 and CD15407  in a Vari ety of Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 cerevisiae . Anyone wishing to submit new scienti fic 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 electr onically, please  use the words “Steviol glycosides  from S. 
cerevisiae  (NOM -0132)” 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: hc.bcs -bipc.sc@canada.ca