Notice of Modification to the List of 
Permitted Food Enzymes to Enable the 
Use of Acid Prolyl Endopeptidase  from 
Aspergillus niger GEP in Certain Foods   
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0155  
October  9, 2020 
 Notice of Modification to the List of Permitted Enzymes  to Enable the Use of Acid Prolyl Endopeptidase  from Aspergillus niger  GEP in 
Certain  Foods  – Reference Number: NOM/ADM -0155| 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  the 
enzyme acid prolyl endopeptidase (a type of protease) from Aspergillus niger GEP in brewers’ mash ; ale,  
beer, light beer, malt liquor, porter , and stout ; distiller’s mash , and  protein hydrolysates (hydrolyzed animal, 
milk and vegetable protein) .  In addition , the use of this enzyme from this source was also requested in  
cereal - and plant -derived ingredients  which  will be further used as ingredients in the manufacture of non -
alcoholic plant -based beverages. As with all food enzymes, the proposed uses described above are intended 
to be used at a level consistent w ith Good Manufacturing Practice .    
Protease  from other sources is  already permitted for use in C anada as a food enzyme  in the same foods  that 
the petitioner has requested, with the exception of brewers’ mash . However, the GEP strain of Aspergillus 
niger , which expresses the protease “ acid prolyl endopeptidase ”, is not a permitted source organism for any 
food enzyme in Canada.  
The results of the Food Directorate’s evaluation of available scientific data support the sa fety of acid prolyl 
endopeptidase from A. niger  GEP for use as requested by the petitioner .  Therefore, Health Canada has 
modified the List of Permitted Food Enzymes  to extend  the use of protease (specifically, the protease “ acid 
prolyl endopeptidase ”) by adding a new entry “(i) acid prolyl endopeptidase ” to column 1 for Item No. P. 6 
and adding the entries in columns 2, 3 and 4 shown below to the new entry (i) of Item No. P. 6 in the List.  
 
Modification to the List of Permitted Food Enzym es 
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 Protease  
(i) Acid prolyl 
endopeptidase  Aspergillus niger  
GEP 
 (1)  
Beer  (1)  
Good Manufacturing 
Practice  
(2)  
Brewers’ mash  (2) 
Good Manufacturing 
Practice  
(3)  
Distillers’ mash  (3)  
Good Manufacturing 
Practice  
(4) 
Hydrolyzed animal, milk 
and vegetable protein  (4)  
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Enzymes  to Enable the Use of Acid Prolyl Endopeptidase  from Aspergillus niger  GEP in 
Certain  Foods  – Reference Number: NOM/ADM -0155| 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  
(5) 
Plant -based beverages  (5)  
Good Manufacturing 
Practice  
  
Ale, malt liquor, porter and stout are not individually listed because these beverages, which formerly had 
their own standards, are now included in the recently amended standard for beer ( B.02.130 ). Therefore, the 
entry for “Beer” includes ale, malt liquor, porter and stout.  
Rationale  
Health Canada’s Food Directorat e completed a premarket safety assessment of the protease acid prolyl 
endopeptidase from A. niger  GEP for use as a  food enzyme.   The assessment concluded that information 
related to allergenicity, chemistry, microbiology, molecular b iology, nutrition, and toxicology  supports the 
safety of this food enzyme  from this source  for its requested uses.  Therefore, the Department has enabled 
the requested uses of acid prolyl endopeptidase from A. niger  GEP by adding to the List of Permitted Food 
Enzymes  the new entr ies as shown in the above table.  
Other Relevant Information  
The Food and Drug Regulations  requi re that food additives such as  the food enzyme acid prolyl 
endopeptidase  that do not have f ood-grade specifications set out in Part B of the Regulations 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 compe ndium 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 Consid erations for Enzyme Preparations  are prepared by the Joint FAO/WHO 
Expert Committee on Food Additives (JECFA) and published by the Food and Agriculture Organization of the 
United Nations.  
Implementation and Enforcement  
The above modification came into force October 9, 2020, 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 Drugs Act and its 
associated regulations with respect to foods.   
Contact Information  
Health Canada's Food Directorate is committed to reviewing any new scientific info rmation on the safety in 
use of any food additive, including acid prolyl endopeptidase from A. niger  GEP.  Anyone wishing to submit 
new scientif ic information on the use of this additive or to submit any inquiries may do so in writing, by Notice of Modification to the List of Permitted Enzymes  to Enable the Use of Acid Prolyl Endopeptidase  from Aspergillus niger  GEP in 
Certain  Foods  – Reference Number: NOM/ADM -0155| 4 
 regular mail or e lectronically.  If you wish to contact the Food Directorate electronically, please use the words 
"acid prolyl endopeptidase  (NOM -0155 )" 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