Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening  
 Agents to Enable the Use of Polysorbate 60 as an Emulsifier in Canned Coconut Milk   
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 60 as an Emulsifier  in Canned 
Coconut Milk  
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: NO M/ADM-0101 
August 14, 2017   
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening  
 Agents to Enable the Use of Polysorbate 60 as an Emulsifier in Canned Coconut Milk   
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 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 four food additive submissions  that together seek approval  for the use of  
polysorbate 60 ( polyoxyethylene (20) sorbitan monostearate ) as an emulsifier in canned coconut 
milk. The requested maximum level of use is 0.05%.  Polysorbate  60 is  already permitted for use in Canada as an emulsifier  in assorted unstandardized 
foods .  The results of Health Canada’s evaluation of available scientific data support the safety of 
polysorbate 60 for use in canned coconut milk up to a maximum level of use of 0.05% .  
Therefore, Health Canada has modified th e 
List of Permitted  Emulsifying, Gelling, Stabilizing or 
Thickening Agents  to extend th e use of  polysorbate 60 by adding the entry shown in the table 
below to the list. 
  
Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or U pon Column 3  
Maximum Level of Use 
and Other Conditions  
P.3 Polyoxyethylene (20)  
Sorbitan Monostearate  
(Polysorbate 60)  (16) 
Canned coconut milk (16) 
0.05%  
 
 
Rationale  
 
Health Canada’s F ood Directorate completed a premarket safety assessment of the requested use 
of polysorbate 60 in canned coconut milk. The assessment did not identify any chemical, 
nutritional, microbiological or  toxicological food safety concerns with the use of this additive .  
Therefore, Health Canada has enabled the requested use of  polysorbate 60 by modifying the List 
of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  as set out in the above table.  
 
   
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening  
 Agents to Enable the Use of Polysorbate 60 as an Emulsifier in Canned Coconut Milk   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as polysorbate 60 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 J oint FAO/WHO Expert Committee on Food Additives 
(JECFA) , is published by the Food and Agriculture Organization of the United Nations  (FAO) . 
 
Implementation and Enforcement  
 
The above modification came into force A ugust 14, 2017, 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 scient ific information on 
the safety in use of any food additive, including polysorbate 60.  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 " Polysorbate 60" 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