Notice of Modification to the List of Permitted Sequestering Agents  to Enable the Use of   
Potassium Phosphate, dibasic  in Infant Cereal  Product s and th e Use of Sodium Potassium Hexame taphosphate  
In Whey Products for Use in Infant Formula  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Health Canada’s Notice of Modification to the List of 
Permitted Sequestering Agents  to Enable the Use of 
Potassium Phosphate, dibasic in Infant Cereal  
Product s and Sodium Potassium Hexametaphosphate 
in Whey Products for Use in Infant Formula  
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: NOM/ADM-0137 
August  7, 2019  
Notice of Modification to the List of Permitted Sequestering Agents  to Enable the Use of   
Potassium Phosphate, dibasic  in Infant Cereal  Product s and th e Use of Sodium Potassium Hexame taphosphate  
In Whey Products for Use in Infant Formula  
  
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 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 in 2012 seeking approval 
for the use of potassium phosphate, dibasic as a sequestering agent in infant cereal  product s at a 
maximum use level of  0.75% .  Potassium phosphate, dibasic is already a permitted for use  in 
Canada  as a sequestering agent in some meat products .  However, section B.25.062 of the Food 
and Drug Regulations  (FDR) prohibits the sale of a food that is labelled or advertised for 
consumption by infant s if the food contains a food additive, and none of the existing exemptions 
to B.25.062 are for the use of potassium phosphate, dibasic in infant cereal products.   Therefore, 
an amendment to the Marketing Authorization for Food Additives that May Be Used a s 
Sequestering Agents  was required in order to exempt potassium phosphate, dibasic, from the 
application  of section B.25.062 of the FDR.   A Notice of Intent to Issue Food Marketing 
Authorization  was published on April 8, 2019, announcing the Government of Canada intent to 
amend the Marketing Authorization for Food  Additives that May Be Use as Sequestering 
Agents.  
 
The results of the Food Directorate ’s evaluation of scientific data support  the safety of potassium 
phosphate, dibasic , when used as described in the table below .  Therefore, Health Canada has 
modified the List of Permitted Sequestering Agents  to extend the use of potassium phosphate, 
dibasic by adding the entries shown below to the list . 
  
Modification to the List of Permitted Sequestering Agents  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3 
Maximum Level of 
Use and Other 
Conditions  
P.4 Potassium 
Phosphate, 
dibasic  (8) Infant cereal products  
 (8) 0.75% total added 
phosphate, calculated 
as potassium 
phosphate, dibasic  
 
  
Notice of Modification to the List of Permitted Sequestering Agents  to Enable the Use of   
Potassium Phosphate, dibasic  in Infant Cereal  Product s and th e Use of Sodium Potassium Hexame taphosphate  
In Whey Products for Use in Infant Formula  
  
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 potassium phosphate, dibasic .  The assessment concluded that the chemical, nutritional, or 
toxicological information that was provided support the safety of potassium phosphate, dibasic 
for its requested use .  Therefore, the Department  has enabled the requested use of potassium 
phosphate, dibasic  by modifying the List of Permitted Sequestering Agents  as shown  in the above 
table.  
 
Enabling the Use of S odium Potassium Hexametaphosphate as a Sequestering 
Agent in Whey Products for Use in Infant Formula  
 
In 2015, the Food Directorate enabled the use of sodium potassium hexametaphosphate as a 
sequestering agent in liquid whey destined for the manufacture of concentrated or dried whey 
products (Update to the Lists of Permitted Food Additives to Enable the Use of Tripotassium 
Phosphate, Potassium Tripolyphosphate, Sodium Potassium Tripolyphosphate and Sodium 
Potass ium Hexametaphosphate in Various Standardized and Unstandardized Foods  - 
NOM/ADM -0048 ).  However, the use of sodium potassium hexametaphosphate in liquid whey 
destined for the manufacture of concentrated or dried whey products to be used in infant formula 
could not be enabled at that time because an amendment of the Marketing Authorization for 
Food Additives That May Be Used as Sequestering Agents  (Marketing Authorization) was 
needed to exempt this use of the food additive from the application of section B. 25.0621 of the 
Regulations.   The Marketing Authorization has recently been amended . The Food Directorate 
will modify sub -item S.5.1(4) of the List of Permitted Sequestering Agents  to exten d the use of 
sodium potassium hexametaphosphate in liquid whey destined for the manufacture of 
concentrated or dried whey products , including concentrated or dried whey products used in 
infant formula . 
 
Modification to the List of Permitted Sequestering Agents  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and Other 
Conditions  
S.5.1  Sodium Potassium 
Hexametaphosphate  (4) Liquid whey destined 
for the manufacture 
of concentrated or 
dried whey products, 
including 
concentrated or dried 
whey products used 
in infant formula  (8) 800 p.p.m. in the concentrated or 
dried whey products, calculated as 
sodium hexametaphosphate.  If used in 
combination with sodium 
hexametaphosphate, the total amount not 
to exceed 800 p.p.m. in the concentrated 
or dried whey product, calculated as 
sodium hexametaphosphate.  
                                              
1 Section B.25.062 of the Food and Drug Regulations  prohibits that sale of a food that is labelled or advertised for  consumption by 
infants if the food contains a food additive .  
Notice of Modification to the List of Permitted Sequestering Agents  to Enable the Use of   
Potassium Phosphate, dibasic  in Infant Cereal  Product s and th e Use of Sodium Potassium Hexame taphosphate  
In Whey Products for Use in Infant Formula  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as potassium phosphate, dibasic  
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 7, 2019 , the day it was published i n the List of 
Permitted Sequestering Agents . 
 
The Canadian Food Inspection Agency is responsible for the enforceme nt 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, inclu ding potassium phosphate, dibasic , and sodium 
potassium hexametaphosphate .  Anyone wishing to submit new scienti fic information on the use 
of these additive s or to submit any inquiries may do so in writing, by regular mail or 
electronically.   If you wish to con tact the Food Directorate electronically, please use the words 
"Potassium phosphate, dibasic  and Sodium potassium hexametaphosphate  (NOM  - 0137)" 
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