Notice of Modification to the List of Permitted 
Emulsifying, Gelling, Stabilizing or Thickening 
Agents  to Enable the Use of Citric Acid Esters of 
Mono - and Diglycerides (CITREM)  as an Emulsifier  
in Whole Protein -Based Infant Formulas  for Special 
Dietary Purposes  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0153 
September  18, 2020 
 Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of CITREM  as an 
Emulsifier  in Whole Prot ein-Based Infant Formulas for Special Dietary Purposes – Reference Number:  [NOM/ADM -0153]  | 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 seeking approval for the use of  citric 
acid esters of mono - and diglycerides (CITREM) as an emulsifier  in whole protein -based infant formulas for 
special dietary or medical uses at a maximu m level of 0.155% as consumed.   Based  on information provided 
in the submission , the intended use of CITREM is captured by the  term ‘whole -protein based infant formul a 
for special dietary purposes’.  Whole protein -based i nfant formulas for special dietary purposes have 
modified fat profiles.  They are typically used to manage the diets of infants with certain allergies or disease -
related malnutrition and failure to thrive . 
CITREM  is already permitted for use in Canada as a n emulsifying agent in infant formulas based on crystalline 
amino acids or protein hydrolysates, or both, at the same  maximum level as the one requested by the 
petitioner .   
The results of the Food Directorate’s evaluation of available scientific data supp ort the sa fety of CITREM 
when used as requested by the petitioner .  Therefore, Health Canada has modified the List of Permitted 
Emulsifying, Gelling, Stabilizing or Thickening Agents  to exte nd the use of CITREM  to whole  protein -based 
infant formula for special dietary purposes  by revising  sub-item (1) for Item C.18 of the list as s hown below.  
 
Modification 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.18  Citric Acid Esters of 
Mono - and Di -
glycerides  (1) 
Infant formula based on 
crystalline amino acids or 
protein hydrolysates, or both; 
Whole protein -based infant 
formula for special dietary 
purposes  (1) 
0.155% as consumed  
 
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of CITREM for use as an 
emulsifying agent .  The assessment concluded that information re lated to allergenicity , chemistry, nutrition, Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of CITREM  as an 
Emulsifier  in Whole Prot ein-Based Infant Formulas for Special Dietary Purposes – Reference Number:  [NOM/ADM -0153]  | 3 
 and toxicology supports the safety of CITREM  for its requested use.  Therefore, the Department has enabled 
the requested use of CITREM  by revising  sub-item (1) for Item C.18 of the List of Permitted Emulsifying, 
Gelling, Stabilizing or Thickening Agents  as shown in the above table.  
Other Relevant Information  
The Food and Drug Regulations  require that food additives such as  CITREM  that do not have food -grade 
specifications set out in Part B of the Regulations meet the food -grade specifications set out in the  mos t 
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 ingredients, 
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 
Expert Committee on Food Additives (JECFA), is published by the Food and Agriculture Organ ization of the 
United Nations.  
Implementation and Enforcement  
The above modification came into force September 18, 2020, 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 scientific information on the safety in 
use of any food additive, including CITREM .  Anyone wishing to submit new scienti fic information on the use 
of this additive  or to submit any inquiri es may do so in writing, by regular mail or electronically.  If you wish 
to contact the Food Directorate electronically, please use the words " CITREM  (NOM -0153)" 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 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca