Notice of Modification to the List of Permitted  
Emulsifying, Gelling, Stabilizing or Thickening 
Agents  to Enable the Use of Polysorbate 80 as an 
Emulsifying Agent in Wheat -based Ready -to-Eat 
Cereals  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0148 
June  15, 2020 
  
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of Polysorbate 
80 in Wheat -based Ready -to-Eat Cereals  – Reference Number: [NOM/ADM -0148]| 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 Pe rmitted 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 foo d 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’s Food Directorate received a food additive submission seeking approval for the use of 
polysorbate 80 as an emulsifying agent in wheat -based ready -to-eat cereals .  The requested maximum level 
of use is 0.05%.  
Polysorbate 80  is already permitted for use in Canada as a n emulsifier in a number of foods, including rice -
based ready -to-eat cereals at a maximum level of 0.1% .   
The results of the Food Directorate’s evaluation of available scientific data support the safety of polys orbate 
80 when used as requested by the petitioner.  Therefore, Health Canada has modified the  List of Permitted 
Emulsifying, Gelling, Stabilizing or Thickening Agents  to extend the use of polysorbate 80 by adding the entry 
shown below to the List. 
Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickenin g 
Agents   
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and Other 
Conditions  
P.2 Polyoxyethylene 
(20) Sorbitan 
Monooleate  
(Polysorbate 80 ) (24) 
Wheat -based ready -to-eat cereals  (24) 
0.05%  
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of polysorbate 80 for use as an 
emulsifying agent  in wheat -based ready -to-eat cereals .  The assessment concluded that information related 
to allergenicity , chemistry, microbiology,  nutrition, and toxicology  supports the safety of polysorbate 80 for 
its requested uses.  Therefore, the Department has enabled the requested use of polysorbate 80 by adding  it 
to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  as shown in the above table.  
Other Relevant Information  
The Food and Drug Regulations  require that food additives such as polysorbate 80 that do not have food -
grade specifications set out in Part B of the Regulations meet the food -grade specifications set out in the 
most recent edition of the Food Chemicals Codex  or the Combined  Compendium of Food Additive  
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of Polysorbate 
80 in Wheat -based Ready -to-Eat Cereals  – Reference Number: [NOM/ADM -0148]| 3 
 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 modi fication came into force June 15, 2020, the day it was published in the List of Permitted 
Emulsifying, Gelling, Stabilizing or Thickening Agents .  
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 polysorbate 80 , that could impact the approved use of the additive . 
Anyone wishing to submit new scientific infor mation 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 "Polysorbate 80 (NOM -0148)" 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 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca