Notice of Modification to the List of Permitted Food Additives with Other Uses  to Enable  
the Use of  Stearic Acid as an An tifoaming Agent in Pre -Cooked ( Instant) Breakfast Cereals   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Permitted 
Food Additives with Other Uses  to Enable the Use 
of Stearic Acid as an Antifoaming Agent in 
Pre-Cooked (Instant ) Breakfast Cereals  
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: [NO M/ADM-0117] 
June 1 , 2018  
Notice of Modification to the List of Permitted Food Additives with Other Uses  to Enable  
the Use of  Stearic Acid as an An tifoaming Agent in Pre -Cooked ( Instant) Breakfast Cereals   
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.  
 
Heal th Canada received a food additive submission seeking approval for the use of stearic acid 
as an antifoaming agent  at a maximum level of use of  2.5%  in instant breakfast cereals . The 
purpose of use is to prevent the cereal s from boiling over while being microwaved or prepared 
on stove top.  
 
The food additive “stearic acid” , as described in the  latest edition of the Food Chemicals Codex , 
is actually a mixture of mainly two fatty acids, stearic acid and palmitic acid .  
 
Steari c acid  is already permitted for use in Canada as a release agent in unstandardized 
confectionery, a plasticizing agent in chewing gum, and a release agent and a lubricant in foods 
sold in tablet form.  
  
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of stearic acid  when used as requested by the petitioner. Therefore, Health Canada has 
modified the List of Permitted Food Additives with Other Acceptable Uses  to extend the use of 
stearic acid  by adding the entry shown below to the list . The maxi mum level of use has been 
identified as “Good Manufacturing Practice” on the basis that fatty acids, including stearic acid  
and palmitic acid,  which are already naturally present in food and are also produced by the 
human body when fat is metabolized, have an Acceptable Daily Intake (ADI) of “not specified” . 
 
Modification to the List of Permitted Food Additives  with Other Acceptable Uses  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Purpose of Use  Column 4  
Maximum Level of Use 
and Other Conditions  
S.14 Stearic  
Acid  (4) 
Pre-cooked (instant) 
breakfast cereals  (4) 
Antifoaming agent  (4) 
Good Manufacturing 
Practice  
 
 
  
Notice of Modification to the List of Permitted Food Additives with Other Uses  to Enable  
the Use of  Stearic Acid as an An tifoaming Agent in Pre -Cooked ( Instant) Breakfast Cereals   
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 use 
of stearic acid . The assessment considered chemical, nutritional, technical , and toxicological 
aspects of this additive, and found that the requested use  is acceptable from a food s afety 
perspective.  
 
Therefore, the Department has enabled the requested use of stearic acid by modifying the List of 
Permitted Food Additives with Other Acceptable Uses  as shown  in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as stearic acid  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 Compend ium 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 abov e modification came into force June 1 , 2018 , the day it was published in the List of 
Permitted Food  Additives with Other Acceptable Uses . 
 
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 stearic acid .  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 electronically, 
please use the words " Stearic A cid (NOM -0117)" 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