Notice of Modification to the  Lists of 
Permitted Food Additives  to Extend the 
Use of Certain Food Additives to 
Human Milk Fortifier s 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NO M/ADM-0164 
April 14 , 2021 
` Notice of Modification to the Lists of Permitted Food Additives  to Extend the Use of Certain Food Additives in Human Milk Fortifier s – 
Reference Number: NOM/ADM -0164| 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.  
Human milk fortifier (HMF) is a food whose composition  includes at least one added vitamin, mineral nutrient 
or amino acid that is labelled or advertised as intended to be added to human milk to increase its nutritional 
value in order to meet the particular requirements of an infant in whom a physical or physiological condition 
exists as a result of a disease, disorder or abnormal state.  Providing HMFs to infants who are born 
prematurely or for other infants as medically required (e.g. small for gestational a ge, high protein needs) is a 
best practice in clinical care. It is used under close medical supervision and monitoring, mostly in neonatal 
intensive care units of hospitals and occasionally at home  as required.  
Health Canada has new regulations that permit the sale of HMF1.  Prior to this, certain HMF products that 
were assessed for safety by Health Canada were allowed to be sold under an agreement between the 
Department and the Canadian Food Inspection Agency.  The safety assessment for those produ cts considered 
six food additives,2 all of which were already permitted for use in infant formula, and found  them to be safe 
for use in HMF.  Now that HMF is defined in the Regulations, the Lists of Permitted Food Additives must be 
modified to permit the u se of these food additives in HMF.   In addition, Health Canada’s Food Directorate 
received a food additive submission seeking approval for the use of gellan gum as a stabilizing agent in liquid 
HMF  based on hydrolysed proteins.  The requested maximum level of use for gellan gum is 225 parts per 
million (ppm), which is equivalent to 0.00415% in the human milk containing the HMF as consumed.   
The Food Directorate  has assessed the safety of the se seven  food additives for use in HMF  and concluded 
that there are no safety concerns with the ir use as set out in the table s below.  
Therefore, Health Canada has modified the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening 
Agents  and th e List of Permitted pH Adjusting Agents, Acid -Reacting Materials and Water Correcting Agents  
to extend the use of  these food additives to HMF  by adding the entries shown below to the Lists. 
Modification s to the Lists of Permit ted Food Additives  
The following entries have 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  
C.15  Carrageenan  (19) 
Hum an milk fortifier  (19) 
0.006%  in the human milk containing the 
human milk fortifier  as consumed  
                                                             
1 Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers) , Canada G azette Part II, SOR/2021 -
57, 2021 -04-14. 
2 These additives are carrageenan as a stabilizing agent, lecithin and monoglycerides as emulsifying agents, and 
potassium citrate, potassium hydroxide and sodium citrate as pH adjusting agents.  Notice of Modification to the Lists of Permitted Food Additives  to Extend the Use of Certain Food Additives in Human Milk Fortifier s – 
Reference Number: NOM/ADM -0164| 3 
` Item 
No. Column 1  
Additive  Column 2  
Permitted in or Upon  Column 3  
Maximum Level of Use and Other Conditions  
G.2 Gellan Gum  (12) 
Human milk fortifier  
based on protein  
hydrolysates  (12) 
0.00415% in the human milk containing the 
human milk fortifier  as consumed  
L.2 Lecithin  (12) 
Human milk fortifier  (12) 
0.03% in the human milk containing the 
human milk fortifier  as consumed  
M.4 Monoglycerides  (14) 
Human milk fortifier  (14) 
0.034% in the human milk containing  the 
human milk fortifier  as consumed  
 
The following entries have been  added  to the List of Permitted pH Adj usting 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.7 Potassium 
Citrate  (5) 
Human milk fortifier  (5) 
Good Manufacturing Practice  
P.9 Potassium 
Hydroxide  (8) 
Human milk fortifier  (8) 
Good Manufacturing Practice  
S.9 Sodium Citrate  (6) 
Human milk fortifier  (6) 
Good Manufacturing Practice  
Rationale  
Health Canada’s Food Directorate assessed the safety  of carrageenan , gellan gum,  lecithin , monoglycerides, 
potassium citrate, potassium hydroxide, and sodium citrate  for use in HMF .  The assessment s conclud ed that 
information related to allergenicity, chemistry, microbiology, nutrition, and toxicology support the s afety of 
these food a dditives  for use as shown  in the tables above .  Therefore, the Department has enabled the uses 
of these food additives  shown in the above tables by adding them to the List of Permitted Emulsifying, 
Gelling, Stabilizing or Thickening Agents  and the List of Permitted pH Adjusting Agents, Acid -Reacting 
Materials and Water Correcting Agents . 
Other Relevant Info rmation  
The Food and Drug Regulations  require that food additives such as carrageenan, gellan gum, lecithin, 
monoglycerides, potassium citrate, potassium hydroxide, and sodium citrate  that do not have food -grade 
specifications set out in Part B of the Regu lations meet the food -grade specifications set out in the  most 
recent  edition of 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 in gredients, 
including food additives, published by the United States Pharmacopeial Convention. The Combined 
Compendium of Food Additive Specifications , which contains specifications prepared by the Joint FAO/WHO Notice of Modification to the Lists of Permitted Food Additives  to Extend the Use of Certain Food Additives in Human Milk Fortifier s – 
Reference Number: NOM/ADM -0164| 4 
` Expert Committee on Food Additives (JECFA), i s published by the Food and Agriculture Organ ization of the 
United Nations.  
Implementation and Enforcement  
The above modification s came into force April 14 , 2021, the day they were  published in  the List of Permitted 
Emulsifying, Gelling, Stabilizing or Thickening Agents  and th e List of Permitted pH Adjusting Agents, Acid -
Reacting Materials and Water Correcting 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 new scientific informati on on the safety in use of 
any permitted food additive, including carrageenan, gellan gum, lecithin, monoglycerides, potassium citrate, 
potassium hydroxide, and sodium citrate .  Anyone wishing to submit new scientific information on the use of 
these additives or to submit inquiries  on this modification  may do so in writing, by regular mail or 
electronically.  If you wish to contact the Food Directorate electro nically, please use the words " Food 
Additives in Human Milk Fortifier  (NOM -0164)" in th e subject line of your e -mail.  
Bureau of Chemical Safety, Food Directorate  
251 S ir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca