Notice of Modification to the List of P ermitted Emulsifying, Gelling, Stabilizing or Thickening Agents , the List of 
Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents , and the List of Permitted 
Sequestering Agents  to Enable the U se of Potassium Pyrophosphate, T etrabasic in Unstandardized Foods  
  
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 , 
the List of Permitted pH Adjusting Agents, Acid -
Reacting Materials and Water Correcting Agents  and 
the List of Permitted Sequestering Agents  to Enable the 
Use of Potassium P yrophosphate, Tetrabasic in 
Unstandardized F oods  
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: NOM/ADM-0128 
March  5, 2019  Notice of Modification to the List of P ermitted Emulsifying, Gelling, Stabilizing or Thickening Agents , the List of 
Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents , and the List of Permitted 
Sequestering Agents  to Enable the U se of Potassium Pyrophosphate, T etrabasic in Unstandardized Foods  
  
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 condi tion 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 th e 
use of potassium pyrophosphate, tetrabasic as a pH adjusting agent, a sequestrant and  a 
texturizing  agent  at a maximum level of use of Good Manufacturing Practice (GMP) in 
unstandardized foods.   
 
The sodium analogue of this additive, s odium  pyrophosphate, tetrabasic , is already permitted for 
these uses in unstandardized foods at a level consistent with GMP. Potassium pyrophosphate, 
tetrabasic  can be used  as a partial or complete rep lacement for the sodium analogue or it can be 
used in place of other phosphate salts  that are permitted in unstandardized foods . Other currently 
permitted food additive uses o f potassium pyrophosphate, tetrabasic  are shown in the List of 
Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents , List of Permitted Sequestering 
Agents , and the List of Permitted Food Additives with Other Accepted Uses .  
 
The results of the Food Directorate ’s evaluation of relevant  scientific data support  the safety and 
efficacy of potassium pyrophosphate, tetrabasic for use as requested by the petitione r. Therefore, 
Health Canada has enabled the requested uses of this additive by adding the entries shown below 
to the List of Permitted Emulsifying, Gelling, Stabilizin g or Thickening Agents , the List of 
Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents , and the 
List of Permitted Sequestering Agents . 
 
 
 
 
 
 
 
 
 
 
 
 Notice of Modification to the List of P ermitted Emulsifying, Gelling, Stabilizing or Thickening Agents , the List of 
Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents , and the List of Permitted 
Sequestering Agents  to Enable the U se of Potassium Pyrophosphate, T etrabasic in Unstandardized Foods  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Modification s to the Lists of Permitted  Food Additives  
 
The existing entry in columns 2 and 3 for item P.11B  has been  renumbered to subitem  “(1)” and 
a new subitem  “(2)” , as shown in the table below , has been  added 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.11B  Potassium 
Pyrophosphate, 
tetrabasic  (2) Unstandardized foods  (2) Good Manufacturing 
Practice  
 
A new item “P.10B” has been  added to the List of Permitted pH Adjusting Agents, Acid -Reacting 
Materials and Water Correcting Agents : 
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon Column 3  
Maximum Level of Use and 
Other Conditions  
P.10B  Potassium 
Pyrophosphate, 
tetrabasic  Unstandardized foods  Good Manufacturing Practice  
 
A new subitem “(9)”  has been  added to Item P.3  in 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.3 Potassium 
Pyrophosphate, 
tetrabasic  (9) Unstandardized foods  (9) Good Manufacturing 
Practice  
 
Consequential Modification  
 
The entries for potassium tripolyphosphate ( Item P.5), sodium acid pyrophosphate ( Item S.1), 
sodium hexametaphosphate ( Item S.3), sodium potassium hexametaphosphate ( Item S.5.1), 
sodium potassium tripolyphosphate ( Item S.5.2), sodium pyrophosphate, tetrabasic ( Item S.6), 
sodium pyrophosphate, tribasic ( Item S.6.1) and sodium tripolyphosphat e (Item S.7) in the List 
of Permitted Sequestering Agents  specify  that these phosphates are permitted in o r upon the same 
foods , at the same levels and other  conditions , as potas sium pyrophosphate, tetrabasic . These 
entries also specifically permit their use in unstandardized foods at a level consistent with GMP. 
However, the se entries for their use in unstandardized foods would be duplicative if retained Notice of Modification to the List of P ermitted Emulsifying, Gelling, Stabilizing or Thickening Agents , the List of 
Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents , and the List of Permitted 
Sequestering Agents  to Enable the U se of Potassium Pyrophosphate, T etrabasic in Unstandardized Foods  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 because  the three new entries shown in the tables above and the existing provisions for the use of 
each of the eight phosphates in the same foods as potassium pyrophosphate, tetrabasic have the 
effect of allowing them in unstandardized foods.  
 
In order to avoid duplication, the specific references to “unstandardized foods” that appear as 
subitem (2) in each of those entries have been  removed  from columns 2 and 3 of items P.5, S.1, 
S.3, S.5.1, S.5.2, S.6, S.6.1, and S.7 and replace d with text indicating the removal date . These 
changes are consequential only and have no effect on the foods, maximum levels of use and 
other conditions for these eight phosphates.  The use of these eight phosph ates in unstandardized 
foods at levels consistent with GMP continues to be permitted.  
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of the requested  
uses of potassium pyrophosphate, tetrabasic . The assessment concluded that information related 
to chemi stry, nutrition, toxicolog y, allergenicity  and efficacy  supports the safety and efficacy of 
potassium pyrophosphate, tetrabasic for its  requested use s. Therefore, the Departmen t has 
enabled the requested use s of potassium pyrophosphate, tetrabasic  by modifying the List of 
Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents , the List of Permitted pH 
Adjusting Agents, Acid -React ing Materials and Water Correcting Agents , and the List of 
Permitted Sequestering Agents  as shown  in first three t ables above . 
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as potassium pyrophosphate, 
tetrabasic  that do not have food -grade specifications set out in Part B of the Regulations meet the 
most recent foo d-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 S tates Pharmacopeial Convention. The Combined Compendium of Food Additive 
Specifications , which contains specifications prepared b y the Joint FAO/WHO Expert 
Committee on Food Additives (JECFA) , is published by the Food and Agriculture Organization 
of the United Nations.  
 
Food additives and other  ingredients  generally must be declared in the list of ingredients on the 
label of pre-packaged foods sold in Canada. Some persons , such as individuals with kidney 
disease or those taking medications that could  impair potassium or phosphorus excretion, need to 
follow a low potassium or low phosphorus diet . They therefore also need to know the a mount of 
potassium or phosphorous in a food to make an informed food choice.  
 
For this reason,  Health Canada recommends that  food companies voluntarily declare the total 
amount of potassium and phosphorus , and the percentage of the “daily value” for potassium and 
phosphorus, in the nutrition facts table when phosphorous - or potassium -containing ingredients 
have been added to a  food. For foods that are offered for sale at retail and that are not required to Notice of Modification to the List of P ermitted Emulsifying, Gelling, Stabilizing or Thickening Agents , the List of 
Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents , and the List of Permitted 
Sequestering Agents  to Enable the U se of Potassium Pyrophosphate, T etrabasic in Unstandardized Foods  
  
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    5 carry  a nutrition facts table, such a s meat products offered at a deli counter, Health Canada 
recommends that the retailer be prepared to inform consumers upon request that the ingredient 
has been added to the food and provide them with the phosphorous and pota ssium content of the 
food.  
 
Declaration of the potassium content of prepackaged foods in the nutrition facts table is 
scheduled to become mandatory as a result of  proposed changes to food labeling requirements , 
published in Part I of the Canada Gazette  on December 14, 2016 .1 Labels will be expected to 
comply with the new labeling requirements by December 2021  unless the deadline changes  as a 
result of  Health Canada’s proposal for front of package labeling .2   
  
Implementation and Enforcement  
 
The above modification came into force March  5, 2019, the day it was published in  the List of 
Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents , the List of Permitted pH 
Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents , and the List of 
Permitted Sequestering Agents . 
 
The Canadian Food Inspection Agency is responsible for the enforcement of th e 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 potassium pyrophosphate, tetrabasic.  Anyone 
wishing to submit new scienti fic 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, pleas e use the words " potassium pyrophosphate, tetrabasic  (NOM -
0128)" 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: hc.bcs -bipc.sc@canada.ca  
 
                                              
1 Canada Gazette , Part II, Vol. 150, No 25, December 14, 2016. SOR/DORS/2016 -305 
2 Canada Gazette  Part I, Vol. 152, No. 6. February 10, 2018