Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protein -glutaminase from Chryseobacterium  
proteolyticum AE-PG in Various Standardized and Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    1 
  
Notice of Modification to the List of Permitted Food 
Enzymes  to Enable the Use  of Protein -glutaminase  
from Chryseobacterium proteolyticum  AE-PG in 
Various Standardized and Unstandardized Foods  
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: NOM/ADM-0130 
March 18, 2019 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protein -glutaminase from Chryseobacterium  
proteolyticum AE-PG in Various Standardized and 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 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 protein -glutaminase from Chryseobacterium proteolyticum  AE-PG in various 
standardized and unstandardized foods . The food enzyme is intended to be used at a l evel 
consistent w ith Good Manufacturing Practice .    
 
The results of the Food Directorate ’s evaluation of available scie ntific data support the safety and 
efficacy of protein -glutaminase from C. proteolyticum  AE-PG when used as set out in the  table 
below . Since this is a food additive that was not previously permitted for use in Canada, Health 
Canada published a Notice of Health Canada’s Proposal to Enable the Use of Protein -
glutaminase from Chryseobacterium proteolyticum AE -PG as a Food Enzyme in Various 
Standardized and Unstandardized Foods  [NOP/ADP -0030] on October 10, 2018 , 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 requeste d uses of protein -
glutaminase from C. proteolyticum  AE-PG 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  
P.6.1  Protein -
glutaminase  Chryseobacterium 
proteolyticum  AE-
PG (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Practice  
(2) 
Hydrolyzed animal, milk 
and vegetable protein  (2) 
Good Manufacturing 
Practice  
(3) 
Pasta  (3) 
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protein -glutaminase from Chryseobacterium  
proteolyticum AE-PG in Various Standardized and Unstandardized Foods   
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  
(4) 
Plant -based beverages  (4) 
Good Manufacturing 
Practice  
(5) 
Unstandardized bakery 
products  (5) 
Good Manufacturing 
Practice  
(6) 
Unstandardized dairy 
products  (6) 
Good Manufacturing 
Practice  
(7) 
Yeast extract  (7) 
Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety and efficacy  assessment of 
protein -glutaminase from C. proteolyticum  AE-PG for use as a food enzyme . The assessment 
concluded that information related to  chemi stry, microbiolog y, nutrition, toxicolog y, and 
allergenicity supports the safety of  protein -glutaminase from C. proteolyticum  AE-PG for its  
requested uses. Therefore, the Department has enabled the requested uses of protein -glutaminase 
from C. proteolyticum  AE-PG by adding to  the List of Permitted Food Enzyme s the new item 
number and its corresponding entries shown in the above table.  
 
Other Relevan t Information  
 
The Food and Drug Regulations  require that food additives such as protein -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 compendium of standards for 
purity and identity for food ingredients, including food additives, published by the United States 
Pharmacopeial Conventio n. The Combined Compendium of Food Additive Specifications  and its 
associated  General Specifications and Considerations 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 received i n response to Health Canada’s Proposal to Enable the Use of 
Protein -glutaminase from Chryseobacterium proteolyticum  AE-PG as a Food Enzyme in V arious 
Standardized and Unstandardized Foods , published on October 10, 2018 . Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protein -glutaminase from Chryseobacterium  
proteolyticum AE-PG in Various Standardized and Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4   
Implementation and Enforcement  
 
The above modification came into force March 18, 2019, the day it was published in the List of 
Permitted Food Enzym es. 
 
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 protein -glutaminase from C. proteolyticum  AE-
PG. 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 u se the words " protein -glutaminase (NOM -0130)" 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