Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of  
Polysorbate 80 in Seasonings and Rice -Based Ready -to-Eat Cereals   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to the List of Permitted 
Emulsifying, Gelling, Stabilizing or Thickening Agents  to 
Enable the Use of Polysorbate  80 in Seasonings and 
Rice -Based Ready -to-Eat Cereals  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0060] 
 
 
 September  15, 2015   
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of  
Polysorbate 80 in Seasonings and Rice -Based Ready -to-Eat 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.  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 n ew 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 th e 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 polysorbate 
80 (polyoxyethylene (20) sorbitan monooleate) in seasonings  at levels consistent with Good 
Manufacturing Practice . The purpose of using this additive is to help disperse the spice 
oleoresins in the seasonings, which are intended for use in a variety of standardized meat and 
poultry products.  Residues of polysorbate 80 are not expected to exceed 0.15% in the final food 
product containing the seasoning.  The residues of polysorbate 80 in the finished product 
containing the seasoning would not exceed 0.15%.  
 
In addition, the Department received a separate foo d additive submission seeking approval for 
the use of polysorbate 80 in rice -based ready -to-eat cereals. In this application, the additive aids 
in solubilizing and dispersing tocopherols throughout the cereal dough during the manufacturing 
process and also  helps to reduce product breakage. The maximum level of use of polysorbate 80 
is 0.1% in the final cereal product.  
 
Polysorbate 80 is  already permitted for use in Canada as an emulsifier in several standardized 
and unstandardized foods, at levels ranging f rom 10 ppm to 0.5%.   The results of Health 
Canada’s evaluation of available scientific data support the safety of polysorbate 80 when used 
in seasonings and in rice -based ready -to-eat cereals as requested by the petitioners.  Therefore, 
Health Canada has m odified the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening 
Agents  to extend the use of polysorbate 80 by adding the entries shown below to the list.   
 
 
 
 
 
 
 
 
 
 
  
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of  
Polysorbate 80 in Seasonings and Rice -Based Ready -to-Eat Cereals   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening 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)  (22) Seasonings for use in 
boneless (naming the 
poultry), brawn, canned 
(naming the poultry), 
headcheese, prepared meat 
(Division 14), prepared 
poultry meat, or preserved 
meat (Division 14)  
 
 (22) Good Manufacturing 
Practice. Residues of 
polysorbate 80 must not 
exceed 0.15% in the 
finished food containing the 
seasoning preparation  
 
 
 
 
(23) Rice -based ready -to-eat 
cereals  (23) 0.1%  
  
Rationale  
 
Health Canada’s Food Directorate has completed a pre -market safety assessment of the requested 
uses of polysorbate 80.  The assessment considered the toxicological and technical aspects of 
these uses 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 polysorbate 80 as set 
out in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations require that food additives such as polysorbate 80, 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 food ing redients, including food additives, which is 
published by the United States Pharmacopeial Convention.  
 
Implementation and Enforcement  
 
The above modification came into force September  15, 2015 , the day it was published in List of 
Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents . 
  
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of  
Polysorbate 80 in Seasonings and Rice -Based Ready -to-Eat Cereals   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 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 . Anyone wishing to su bmit 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 " polysorbate 80 " 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