Notice of Modification to the List of Permitted Sweeteners to Enable the Use of Advantame as a Sweetener  
in Certain Unstandardized Foods Including Certain Beverages   
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 Advantame as a Sweetener in Certain 
Unstandardized Foods Including Certain Beverages  
Notice of Modification – Lists of Permitted Food Additives   
Reference Number: [NOM/ADM -0092] 
 
 
 
April  19, 2017   
Notice of Modification to the List of Permitted Sweeteners to Enable the Use of Advantame as a Sweetener  
in Certain Unstandardized Foods Including Certain Beverages   
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 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 additives when used under specified conditions in foods 
sold in  Canada.  
 
Health Canada received a food additive submission seeking approval for the use of advantame as 
a sweetener in certain unstandardized foods, including unstandardized beverages. The results of 
Health Canada’s evaluation of available scientific data support the safety and efficacy of 
advantame when used as requested by the petitioner.   
 
Because this is a food additive that was not previously permitted for use in Canada, Health 
Canada published a Notice of Health Canada’s Proposal to Enable the Use of a New Food 
Additive, Advantame, as a Sweetener in Certain Unstandardized Foods Including Certain 
Beverag es - Reference Number: NOP/AD P-0022 . The proposal was published on October 27, 
2016, and was open to the public for comments for 75 days. No new scientific information was 
submitted to the Department during the comment period in response to this Notice of Proposal.  
 
Since the conclusions of the evaluation remain as described in the Notice of Proposal (NOP), 
Health Canada has modified the List of Permitted Sweeteners  by adding the item shown in the 
table below to the List . This item has been revised slightly from the one that was published in the 
NOP by (1) adding text to the fourth entry to clarify that the conditions of use in unstandardized 
beverages and their concentrates and mixes do not apply to unstandardized coffee beverages, 
unstandardized tea beverages, and concentrates and mixes thereof, for which there are separate 
conditions of use; and (2)  re-ordering the sequence of the entries in columns 2 and  3 (French 
version only).  
 
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  
A.02  
 
 Advantame  
 
 (1) Table -top sweeteners  (1) Good Manufacturing Practice  
(2) Baking mixes; Unstandardized 
bakery products  (2) 18 p.p.m. in products as consumed  
(3) Breakfast cereals; Nut spreads; 
Peanut spreads;  Unstandardized (3) 10 p.p.m.   
Notice of Modification to the List of Permitted Sweeteners to Enable the Use of Advantame as a Sweetener  
in Certain Unstandardized Foods Including Certain Beverages   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 fruit spreads; Unstandardized 
purées; Unstandardized table syrups  
(4) Unstandardized beverages 
except unstandardized coffee 
beverages and unstandardized tea 
beverages; Unstandardized 
beverage concentrates except 
unstandardized coffee beverage 
concentrates and unstandardized tea 
beverage concentrates; 
Unstandardized beverage  mixes 
except unstandardized coffee 
beverage mixes and unstandardized 
tea beverage mixes; Unstandardized 
desserts; Unstandardized dessert 
mixes  (4) 10 p.p.m. in products as consumed  
(5) Unstandardized coffee 
beverages; U nstandardized coffee 
beverage concentrates;  
Unstandardized coffee beverage 
mixes; Unstandardized tea 
beverages; Unstandardized tea 
beverage concentrates;  
Unstandardized tea beverage mixes  (5) 3 p.p.m. in beverages as consumed  
(6) Breath freshener products; 
Chewing gum  (6) 400 p.p.m.  
(7) Confectionery glazes for snack 
foods; Sweetened seasonings or 
coating mixes for snack foods; 
Unstandardized confectionery; 
Unstandardized confectionery 
coatings  (7) 20 p.p.m.  
(8) Fillings; Filling mixes; 
Toppings; Topping mixes  (8) 20 p.p.m.  in products as consumed  
(9) Marinades  (9) 3 p.p.m.  
(10) Unstandardized salad dressings  (10) 5 p.p.m.  
(11) Unstandardized condiments; 
Unstandardized sauces  (11) 4 p.p.m.  
(12) Broths; Soups; Soup mixes  (12) 2 p.p.m. in products as consumed  
(13) Dietetic confectionery; Dietetic 
confectionery coatings  (13) 60 p.p.m.  
(14) Yogurt  (14) 6 p.p.m.  
  
Notice of Modification to the List of Permitted Sweeteners to Enable the Use of Advantame as a Sweetener  
in Certain Unstandardized Foods Including Certain Beverages   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 Rationale  
 
As summarized in the Notice of Proposal (NOP), Health Canada’s Food Directorate conducted a 
premarket safety and efficacy assessment of advantame for use as a food sweetener . The 
assessment did not identify any food safety concerns with respect to the uses of advantame that 
were requested by the petitioner, nor was any new scientific information submitted in response to 
the NOP . Therefore,  Health Canada has enabled the requested uses of this sweetener by 
modifying the List of Permitted Sweeteners  as shown in the above table.  
 
Other Relevant Inform ation  
 
The Canadian Food and Drug Regulations require that food additives such as advantame, which 
do not have specifications set out in the Regulations, meet the food -grade specifications set out 
in the most recent edition of the Food Chemicals Codex (FCC) or the most recent edition of the  
Combined Compendium on Food Additive Specifications . The FCC is a compendium of 
standards for purity and identity for food ingredients, including food additives, which is 
published by the United States Pharmacopeial  Convention. The Combined Compendium on Food 
Additive Specifications  is prepared by the Joint FAO/WHO Expert Committee on Food Additives 
(JECFA) and is published by the Food and Agriculture Organization of the United Nations.  
 
Notification – Summary of Com ments  
 
Health Canada received five responses to the Notice of Proposal during the comment period, 
four from food industry associations and one from a distributor. No scientific information 
relating to the safety evaluation was provided. The comments were u nanimously supportive of 
the proposal, indicating that this food additive will provide a new low -calorie sweetener for use 
in various foods and beverages. Three of the four industry associations and the distributor 
indicated that enabling advantame would s upport product innovation, while the other industry 
association commented that legally enabling advantame would facilitate trade with other 
jurisdictions where advantame is permitted.  
 
One response included a request to increase the maximum level of use for advantame in some 
food categories. Health Canada replied to the respondent indicating that such requests can be 
addressed through the food additive submission process.  
 
Implementation and Enforcement  
 
The above modifications came into force April  19, 2017 , the day they were published in the List 
of Permitted Sweeteners . 
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Dr ugs 
Act and its associated regulations with respect to foods.  
  
Notice of Modification to the List of Permitted Sweeteners to Enable the Use of Advantame as a Sweetener  
in Certain Unstandardized Foods Including Certain Beverages   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 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 advantame . 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 elec tronically, 
please use the word  "advantame " 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