Notice of Modification to the List of Permitted Preservatives  to In crease the Maximum Level  
of Use of Calcium Propionate and Potassium Sorbate in Roti   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the  List of Permitted 
Preservatives  to Increase  the Maximum Level of 
Use of  Calcium Propionate and Potassium 
Sorbate in Roti  
 
Notice of Modification – Lists  of Permitted Food Additives  
Reference Number: NOM/ADM -0115 
May 25, 2018  
Notice of Modification to the List of Permitted Preservatives  to In crease the Maximum Level  
of Use of Calcium Propionate and Potassium Sorbate in Roti   
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 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 seek ing an increase in the maximum level of 
use for the preservatives calcium propionate and potassium sorbate , respectively, in roti, a 
traditional flatbread. For regulatory purposes roti is an unstandardized food. As such it has been  
permitted to contain  calcium propionate at a maximum level of  2,000 parts per million (p.p.m.)  
(calculated as propionic acid)  and potassium sorbate at a maximum level of  1,000 p.p.m 
(calculated as sorbic acid).  
 
The petitioner requested that the maximum permitted level for calcium propionate in roti be 
increased to 4,000 p.p.m. and for potassium sorbate to 5,000 p.p.m . in order  to increase the shelf 
life of the product .  These are the same maximum levels of these pre servatives that are permitted 
for use in soft flour tortillas, a flatbread that is similar to roti.  
 
Health Canada’s evaluation of available scie ntific information support s the safety of calcium 
propionate and potassium sorbate for use  in roti  as requested by the petitioner.  Therefore, Health 
Canada has increased the maximum level of use for these preservatives in roti by modifying Part 
3 of the List of Permitted Preservatives  to include the entries show n in the table below . 
 
Modification to  Part 3 of  the List of Permitted  Preservatives  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon Column 3  
Maximum Level of Use and Other 
Conditions  
C.1 Calcium 
Propionate  (2) 
Roti; Soft flour tortillas  (2) 
4,000 p.p.m.  
P.1 Potassium 
Sorbate  (2) 
Roti; Soft flour tortillas  (2) 
5,000 p.p.m.  
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of  the requested use 
of calcium propionate and potassium sorbate .  The assessment  did not identify any  chemical,  
Notice of Modification to the List of Permitted Preservatives  to In crease the Maximum Level  
of Use of Calcium Propionate and Potassium Sorbate in Roti   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 microbiological, nutritional, or toxicological safety concerns.  Therefore, the Department has 
enabled th e requested  use of  calcium propionate and potassium sorbate  by modifying  Part 3 of  
the List of Permitted Preservatives  as shown  in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as calcium propionate and 
potassium sorbate  that do not have food -grade specifications set out in Part B of the Regulations 
meet the most recent food -grade 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 by the Joint FAO/WHO Expert 
Committee on Food Additives (JECFA) , is published by the Food and Agriculture Organization 
of the United Nations.  
 
Implementation and Enforcement  
 
The above modification s came into force May  25, 2018, the day they were  published in Part 3 of 
the List of Permitted Preservatives . 
 
The Canadian Food Inspection Agency is responsible for the enfor cement of the Food and Drugs 
Act and its associated regulations with respect to foods.  
 
Contact Information  
 
Enquiries about permitted food additives or new scientific information on the safety in use of 
permitted food additives  can be submitted to the Food Directorate in writing  by e-mail or regular 
mail.   If you wish to contact the Food Directorate by e-mail specifically about this Notice of 
Modification for calcium propionate and potassium sorbate , please use the words  “calcium  
propionate  and potassium sorbate  (NOM -0115 )” 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