Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Saccharin and its Calcium,  
Potassium and Sodium Salts as Sweeteners in Preoperative 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 Saccharin and its Calcium, 
Potassium and Sodium Salts as Sweeteners in 
Preoperative Beverages  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0066] 
 
January  21, 2016   
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Saccharin and its Calcium,  
Potassium and Sodium Salts as Sweeteners in Preoperative 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 th eir 
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 petiti oner 
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 d etermine 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 saccharin, 
calcium saccharin, potassiu m saccharin and sodium saccharin as sweeteners at a maximum level 
of use of 0.03%, calculated as saccharin in preoperative beverages.  
 
Saccharin and its salts are  already permitted for use in Canada as sweeteners in various food 
categories.   
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
saccharin and its calcium, potassium and sodium salts when used as requested by the petitioner.  
Therefore, Health Canada has modified  the List of Permitted Sweeteners  to extend the use of 
saccharin and its calcium, potassium and sodium salts  by adding the entry shown below to 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.01 Saccharin  (9) Preoperative 
beverages  (9) 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.  
 
As items C.1 (calcium saccharin), P.1 (potassium saccharin) and S.01.1 (sodium saccharin) 
indicate that each is permitted f or use in or upon the “ Same foods as listed for Saccharin”, this 
modification above will also enable the use of calcium saccharin, potassium saccharin and 
sodium saccharin in preoperative beverages at the same levels and conditions as prescribed for 
sacch arin. 
  
Notice of Modification to the List of Permitted Sweeteners  to Enable the Use of Saccharin and its Calcium,  
Potassium and Sodium Salts as Sweeteners in Preoperative Beverages   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of the requested 
uses of saccharin and its salts .  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 
saccharin and its calcium, potassium and sodium salts by modifying the List of Permitted 
Sweeteners  as described in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations require that food additives such as saccharin and its calcium, 
potassium and sodium salts , 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). 
The FCC is a compendium of standards for purity and identity for f ood ingredients, including 
food additives, which is published by the United States Pharmacopeial Convention.    
 
Implementation and Enforcement  
 
The above modification came into force January 21, 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 saccharin and its calcium, potassium and sodium 
salts in preoperative beverages . 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 word s “saccharin and 
its calcium, potassium and sodium salts in preoperative beverages ” 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