Health Canada’s Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of 
Glutaminase f rom Bacillus amyloliquefaciens GT2 in Various Unstandardized F oods  
 
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Health Canada’s Notice of Modification to the  List of 
Permitted Food Enzymes  to Enable  the Use of  
Glutaminase  from Bacillus amyloliquefaciens GT2 in 
Various Unstandardized F oods   
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: NOM/ADM -0139 
September 4 , 2019  
  
 
Health Canada’s Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of 
Glutaminase f rom Bacillus amyloliquefaciens GT2 in Various Unstandardized F oods  
 
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 Per mitted 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 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 the 
use of the enzyme glutaminase from Bacillus amyloliquefaciens  GT2 in dairy -based flavouring 
preparations and other unstandardized flavouring preparations, yeast e xtract, hydrolyzed animal, 
milk and vegetable protein, and unstandardized egg products. The food enzyme is intended to be 
used at a level consistent with Good Manufacturing Practice.  
 
The results of the Food Directorate’s evaluation of available scie ntific  data support the safety and 
efficacy of glutaminase  from B. amyloliquefaciens GT2 when used as set out in the table below. 
Since this is a food additive that was not previously permitted for use in Canada, a Notice of 
Health Canada’s Proposal to Enable the Use of Glutaminase from Bacillus amyloliquefaciens 
GT2 as a Food Enzyme in Various Unstandardized Foods  [NOP/ADP -0031] was published on 
February 4, 2019 , which was open to the public for comment for 75 days . No new scientific 
information was submitted to the Department as a result of this Notice of Proposal . Since the 
conclusions of the evaluation remain as described in the publication, Health Canada has enabled 
the requested uses of glutaminase from B. amyloliquefaciens  GT2 by adding the entries shown in 
the table below to the List of Permitted Food Enzymes .  
 
 
 
Modification to the List of Permitted Food Enzymes  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of 
Use and Other 
Conditions  
G.5 Glutaminase  Bacillus 
amyloliquefaciens GT2 (1)  
Dairy -based flavouring 
preparations  (1) 
Good Manufacturing 
Practice  
(2) 
Hydrolyzed animal, 
milk and vegetable 
protein  (2) 
Good  Manufacturing 
Practice   
  
 
Health Canada’s Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of 
Glutaminase f rom Bacillus amyloliquefaciens GT2 in Various Unstandardized F oods  
 
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Item 
No. Column 1  
Additive  Column 2  
Permitted Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of 
Use and Other 
Conditions  
(3) 
Unstandardized egg 
products  (3) 
Good Manufacturing 
Practice  
(4) 
Yeast Extract  (4) 
Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety and efficacy assessment of 
glutaminase from B. amyloliquefaciens  GT2 for use as a food enzyme . The assessment 
concluded that information related to  allergenicity , chemistry, microbiolog y, nutrition, and 
toxicolog y supports the safety of  glutaminase from B. amyloliquefaciens  GT2 for its  requested 
uses. Therefore, the Department has enabled the requested uses of glutaminase from B. 
amyloliquefaciens  GT2 by adding to  the List of Permitted Food Enzymes  the new item number 
and its corresponding entries shown in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as glutaminase 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  and its 
associated General Specifications and Co nsiderations for Enzyme Preparations  are both 
prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA)  and published 
by the Food and Agriculture Organization of the United Nations.  
 
Notification – Summary of Comments  
 
No comments were rece ived i n response to  the Notice of Health Canada’s Proposal to Enable 
the Use of Glutaminase from Bacillus amyloliquefaciens GT2 as a Food Enzyme in Various 
Unstandardized Foods  – [NOP/ADP -0031 ], published on February 4, 2019.  
  
 
 
 
  
  
 
Health Canada’s Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of 
Glutaminase f rom Bacillus amyloliquefaciens GT2 in Various Unstandardized F oods  
 
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 Implementation and Enforcement  
 
The above modification came into force September 4 , 2019 , the day it was published in the List 
of Permitted Food Enzymes . 
 
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and D rugs 
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 glutaminase from Bacillus  amyloliquefaciens  
GT2. Anyone wishing to submit new scient ific 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, please use the words " Glutaminase (NOM -0139)" 
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