Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of Xanthan Gum  
as a Thickening Agent in Infant Formula Based on Isolated Amino Acids or Protein Hydrolysates, or Both   
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  to 
Enable the Use of Xanthan Gum as a Thickening Agent 
in Infant Formula Based on Isolated Amino Acids or 
Protein Hydrolysates, or Both  
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0040] 
 
 
 Octo ber 24, 2014   
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of Xanthan Gum  
as a Thickening Agent in Infant Formula Based on Isolated Amino Acids or Protein Hydrolysates, or Both   
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.  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 Hea lth Canada’s 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 received a food additive submission seeking approval for the use of xantha n gum 
as a thickening agent in infant formula that is based on isolated amino acids or protein 
hydrolysates, or both.  
 
Xanthan gum is already permitted for use in Canada as a thickening agent in a variety of 
standardized foods at levels consistent with GM P or up to 0.5%.   
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
xanthan gum in infant formula that is based on isolated amino acids or protein hydrolysates , or 
both, at a maximum level of use of 0.075% as consumed. Therefore, Health Canada has modified 
the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to extend the use of 
xanthan gum in this type of infant formula by adding the entry shown below to the list.   
 
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  
X.1 Xanthan 
Gum  (12) Infant formula based 
on isolated amino 
acids or protein 
hydrolysates, or both  
 (12) 0.075% as consumed  
 
 
 
 
 
 
  
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents  to Enable the Use of Xanthan Gum  
as a Thickening Agent in Infant Formula Based on Isolated Amino Acids or Protein Hydrolysates, or Both   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of the use of 
xanthan gum in infant formula based on isolated amino acids or protein hydrolysates, or both. 
The assessment considered microbiological, toxicological, nutritional and chemical aspects of 
xanthan gum when used in this food application.     
 
Based on the results of the safety assessment, Health Canada’s Food Directorate considers that 
the data support the safety of xanthan gum when used under the conditions of use set out  in the 
table above.  The Department has therefore enabled the use of xanthan gum as described in the 
above table.  
 
Other Relevant Information  
 
Xanthan gum, when used as a food additive in foods sold in Canada, must meet food -grade 
specifications for this  additive set out in the most recent edition of the Food Chemicals Codex 
(FCC).  The FCC is a compendium of standards for the purity and identity of food ingredients, 
including food additives, which is published by the United States Pharmacopeial Conventio n. 
 
Implementation and Enforcement  
 
The above modification came into force Octo ber 24, 2014 , 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 xanthan gum . Anyone wishing to submit new 
scientific information on the use of xanthan gum in infant formula base d on isolated amino acids 
or protein hydrolysates, or both  or wishing or to submit any inquiries may do so in writing, by 
regular mail or electronically. If you wish to contact the Food Directorate electronically, please 
use the words " xanthan gum in infant formula based on isolated amino acids or protein 
hydrolysates, or both " in the subject line of your e -mail.  
 
Bureau of Chemical Safety , Food Directorate  
251 Sir Fred erick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0L2  
E-mail:  bcs-bipc@hc -sc.gc.ca