Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Saccharin, Calcium Saccharin,  
Potassium Saccharin and Sodium Saccharin as Sweeteners 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 Saccharin, Calcium 
Saccharin, Potassium Saccharin and Sodium 
Saccharin as Sweeteners in Various Unstandardized 
Foods  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0026] 
 
 
 April  24, 2014   
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Saccharin, Calcium Saccharin,  
Potassium Saccharin and Sodium Saccharin as Sweeteners 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  (FDR) . 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.  A petitioner can r equest 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 w hether 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 saccharin as a 
sweetener in various unstandardized foods.  
 
On October 7, 2013, Health Canada published a Consultation Document on Health Canada’s 
Proposal to Enable the Use of Saccharin, Calcium Saccharin, Potassium Saccharin and Sodium 
Saccharin as Sweeteners in Various Unstandardized Foods  seeking comments on  the proposal.  
No new scientific information was submitted to the Department as a result of this publication. 
Since the conclusions of the evaluation remain as described in the publication, Health Canada 
has modified the List of Permitted Sweeteners  as described in that document with one minor 
change, namely to the description of the food category “Unstandardized non -alcoholic 
beverages”.  For the purpose of clar ification, Health Canada has modified this food category as it 
appears in column 2 of the table to read “Unstandardized carbonated non -alcoholic beverages”.  
This wording more accurately describes the food category requested in the submission and which 
was considered in the safety evaluation.  
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
saccharin, calcium saccharin, potassium saccharin and sodium saccharin when used as described 
below.   
 
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  
C.1 Calcium saccharin  Same foods as listed 
for Saccharin  Same levels  and conditions 
as prescribed for saccharin  
P.1 Potassium 
saccharin  Same foods as listed 
for  Saccharin  Same levels  and conditions 
as prescribed for saccharin  
S.01 Saccharin  (1) 
Breath freshener 
products  (1) 
0.15% calculated as 
saccharin. If any 
combination of saccharin, 
calcium saccharin,  
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Saccharin, Calcium Saccharin,  
Potassium Saccharin and Sodium Saccharin as Sweeteners in Various Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 potas sium saccharin or 
sodium saccharin is used, 
the total amount not to 
exceed 0.15%, calculated 
as saccharin.  
(2) 
Unstandardized  
canned  fruit (2)  
0.01% calculated as 
saccharin. If any 
combination of saccharin, 
calcium saccharin, 
potassium saccharin or 
sodium saccharin is used, 
the total amount not to 
exceed 0.01%, calculated 
as saccharin.  
(3)  
Chewing gum  (3) 
0.25% calculated as 
saccharin. If any 
combination of saccharin, 
calcium saccharin, 
potassium saccharin or 
sodium saccharin is used, 
the total amount not to 
exceed 0.25%, calculated 
as saccharin.  
(4) 
Unstandardized frozen 
desserts  (4) 
0.0025% calculated as 
saccharin. If any 
combination of saccharin, 
calcium saccharin, 
potassium saccharin or 
sodium saccharin is used, 
the total amount not to 
exceed 0.0025%, calculated 
as saccharin.  
(5) 
Toppings; Topping 
Mixes  (5) 
0.09% calculated as 
saccharin. If any 
combination of saccharin, 
calcium saccharin, 
potassium saccharin or 
sodium saccharin is used, 
the total amount not to 
exceed 0.09%, calculated  
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Saccharin, Calcium Saccharin,  
Potassium Saccharin and Sodium Saccharin as Sweeteners in Various Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 as saccharin.  
(6) 
Unstandardized 
alcoholic liqueurs  (6) 
0.12% calculated as 
saccharin. If any 
combination of saccharin, 
calcium saccharin, 
potassium saccharin or 
sodium saccharin is used, 
the total amount not to 
exceed 0.12%, calculated 
as saccharin.  
(7) 
Unstandardized 
carbonated non -
alcoholic beverages  (7) 
0.03% calculated as 
saccharin. If any 
combination of saccharin, 
calcium saccharin, 
potassium saccharin or 
sodium saccharin is used, 
the total amount not to 
exceed 0.03%, calculated 
as saccharin.  
(8)  
Unstandardized fruit 
spreads  (8) 
0.02% calculated as 
saccharin. If any 
combination of saccharin, 
calcium saccharin, 
potassium saccharin or 
sodium saccharin is used, 
the total amount not to 
exceed 0.02%, calculated 
as saccharin.  
S.01.1  Sodium Saccharin  Same foods as listed 
for saccharin  Same levels  and conditions 
as prescribed for saccharin  
 
 
Rationale  
Health Canada's Food Directorate has completed a pre -market safety assessment of saccharin, 
calcium saccharin, potassium saccharin and sodium  saccharin when used as described above. 
The assessment focused on toxicological aspects of the proposal.  
Based on the results of the safety assessment and the fact that no new scientific safety 
information has become available that would alter the conclus ions of the safety assessment, 
Health Canada considers that the data demonstrate the safety of saccharin, calcium saccharin,  
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Saccharin, Calcium Saccharin,  
Potassium Saccharin and Sodium Saccharin as Sweeteners in Various Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 potassium saccharin and sodium saccharin as sweeteners under the conditions of use set out 
above. The Department has therefore enab led the use of saccharin as described in the above 
table.  
 
Other Relevant Information  
 
Saccharin, calcium saccharin and sodium saccharin used in foods sold in Canada must meet the 
food-grade specifications set out in the most recent edition of the Food Chemicals Codex (FCC). 
The FCC is a compendium of standards for purity and identity of food ingredients, including 
food additives, which is published by the United States Pharmacopeial Convention.  Since the 
FCC does not currently have a monograph wit h specifications for potassium saccharin (at the 
time of the publication of this document), Health Canada considers the food -grade specifications 
for potassium saccharin established by the Joint FAO/WHO Expert Committee on Food 
Additives (JECFA) to be acce ptable.  
 
As described in the Consultation Document on Health Canada’s Proposal to Enable the Use of 
Saccharin, Calcium Saccharin, Potassium Saccharin and Sodium Saccharin as Sweeteners in 
Various Unstandardized Foods , Health Canada intends to enable the us e of saccharin, calcium 
saccharin, potassium saccharin, and sodium saccharin as food additives in table -top sweeteners. 
As food additives, they would be subject to the general food additive requirements set out in Part 
B of the FDR.  In the meantime, sacch arin and its salts as listed above continue to be permitted 
for sale as saccharin sweeteners under specific labelling and point -of-sale conditions prescribed 
in Part E of the Food and Drug Regulations (FDR) .  
 
Notification – Summary of Comments   
 
In response to the Consultation Document on Health Canada’s Proposal to Enable the Use of 
Saccharin, Calcium Saccharin, Potassium Saccharin  and Sodium Saccharin as Sweeteners in 
Various Unstandardized Foods , published on October 7, 2013, Health Canada received four 
comments.   
 
Three comments were received from domestic and foreign industry associations.  A fourth was 
received from a national  government. All three association responses indicated support for the 
proposal.  
 
One of these associations and a national government requested that modifications to the listing 
be made to allow for broader use of these food additives. In response, Health Canada has 
indicated that  the permitted foods and the maximum levels of use are based on the results of the 
safety evaluation of the requested maximum levels of use and the requested foods set out in the 
food additive submission, and that the Department ca n consider a new food additive submission 
requesting an extension of use for these sweeteners to include a new food or a different 
maximum level of use.   
  
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Saccharin, Calcium Saccharin,  
Potassium Saccharin and Sodium Saccharin as Sweeteners in Various Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     6 Implementation and Enforcement  
 
The above modification came into force April 24, 2014 , 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 new scientific information on the 
safety in use of any permitted food additive, including s accharin, calcium saccharin, potassium 
saccharin and sodium saccharin . Anyone wishing to submit new scientifi c information on the use 
of these food  additive s or to submit any inquiries may do so in writing, by regular mail or 
electronically. If you wish to contact t he Food Directorate elec tronically, please use the word  
"saccharin " 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