Health Canada’s Notice of Modification to the List of Permitted Food Additives with Other Accepted Uses  
to Enable the Use of  Polysorbate 80 in Bacterial Cultures  Intended for Use  
in Various  Infant  Foods  and Nutritional Supplement Powders  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Health Canada’s Notice of Modification to the List of 
Permitted Food Additives with Other Accepted Uses to 
Enable the Use of Polysorbate  80 in Bacterial 
Cultures Intended for Use in Various Infant Foods  
and Nutritional Supplement Powders  
 
Notice of Modification –  Lists of Permitted Food Additives  
Reference Number: NOM/ADM -0138 
August 13, 2019 Health Canada’s Notice of Modification to the List of Permitted Food Additives with Other Accepted Uses  
to Enable the Use of  Polysorbate 80 in Bacterial Cultures  Intended for Use  
in Various  Infant  Foods  and Nutritional Supplement Powders  
  
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 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. 
 
Health Canada ’s Food Directorate  received a food additive submission seeking approval for the 
use of polysorbate  80 (polyoxyethylene (20) s orbitan m onooleate ) to improve the survival rate of 
bacterial cells in bacterial cultures during  the spray -drying  process. The resulting bacterial 
culture powder  is not consumed directly, but rather  is intended to be added as an ingredient to : 1) 
infant formula powder, 2)  dried infant cereal, and 3) powdered nutritional supplements for 
toddlers  (1 to 3 years of age). The amount of polysorbate 80 carried over from the bacterial 
culture ingredient to these three categories of food  would be no more than 3  ppm, 6 ppm, and 3 
ppm respectively . 
 
Polysorbate 80 is already permitted for use in Canada as an  emulsifying, gelling, stabilizing or 
thickening agent in a variety of foods .   
 
The results of the Food Directorate’s  evaluation of available scientific data support the safety of 
polysorbate 80 when used as requested by the petitioner. T here are no safet y concerns with the 
consumption of polysorbate 80 from spray -dried bacterial cultures in nutritional supplements if  
consumed by older children and adults  because the consumption from nutritional supplements 
would remain negligible compared to tot al dietary  intake. In addition, the re is no specific 
definition  for “toddler” in the Food and Drugs Act  or the Regulations . The Food Directorate has 
modified the listing for use in nutritional supplements to be applicable to the general population.  
Therefore, Health Canada has modified the  List of Permitted Food Additives with Other 
Accepted Uses  by addi ng the entry shown below to the list .  
 
 
 
 
 
 
 
 
 
 
 Health Canada’s Notice of Modification to the List of Permitted Food Additives with Other Accepted Uses  
to Enable the Use of  Polysorbate 80 in Bacterial Cultures  Intended for Use  
in Various  Infant  Foods  and Nutritional Supplement Powders  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Modification to the List of Permitted Food Additives with Other Accepted 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  
P.2C  Polyoxyethylene 
(20) Sorbitan 
Monooleate  
(Polysorbate 80)  Spray -dried bacterial 
culture preparations 
for use in  dried infant 
cereal products,  
infant formula 
powder s, or 
nutritional 
supplement powder s To improve viability 
of spray -dried 
bacterial cultures  Good manufacturing 
practice; not to 
exceed 6 p.p.m. in 
dried infant cereal 
products; 3 p.p.m. in 
infant formula 
powder s; or 3 p.p.m. 
in nutritional 
supplement powder s 
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of polysorbate 80 to 
improve the survival rate of bacterial cells during spray -drying . The assessment concluded that 
information related to chemistry , molecular biology , nutrition, and toxicology  supports the safety 
of polysorbate 80 for its  requested uses . Therefore, the Department has enabled the requested 
uses of polysorbate 80 by adding to the List of Permitted Food Additives with Other Accepted 
Uses  the new entry  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 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 co mpendium 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 Jo int 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 came into force August  13, 2019, the day it was published in the  List of 
Permitted Food Additives with Other Accepted 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.  
 Health Canada’s Notice of Modification to the List of Permitted Food Additives with Other Accepted Uses  
to Enable the Use of  Polysorbate 80 in Bacterial Cultures  Intended for Use  
in Various  Infant  Foods  and Nutritional Supplement Powders  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 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 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 electro nically, 
please use the words " polysorbate 80 (NOM -0138) " 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