Notice of Modification to the List of 
Permitted Food Enzymes  to Enable  the 
Use of Carboxypeptidase D from 
Aspergillus oryzae  AT1727 in Various 
Foods  
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0201 
May 23, 2023 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Carboxypeptidase D from Aspergillus oryzae  
AT1727 in Various Foods | 2 
 Summary  
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by th e Minister of 
Health and the Food and Drug Regulations  (Regulations) . Authorized  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 t he Canada.ca website. A petitioner can request that Health Canada authorize  a 
new additive , or a new source  or a new condition of use for an already permitted  food additive , by filing a 
food additive submission with the Department's Food Directorate. Healt h Canada uses this premarket 
authorization  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 submiss ion seeking authorization  for the use of 
carboxypeptidase D from Aspergillus oryzae  AT1727 in  the manufacture of  bakery products ;1 bread ;2 Colby 
cheese ; dairy -based flavouring preparations ; flour ; hydrolyzed animal, milk and vegetable proteins ; 
hydrolyze d yeast ; spray -dried cheese powder ; meat tenderizing preparations ; plant -based foods ; pre-cooked 
(instant) breakfast cereals ; whole wheat flour  and yeast extract .  
Carboxypeptidase D , which is a type of protease, is intended to be used to catalyze the hydrolysis of proteins . 
The requested maximum level of use for this food enzyme is Good Manufacturing Practice.  
Carboxypeptidase from A. niger  PEG-1 is already permitted for use in dairy -based flavouring preparations , 
preserved meat,  sausage, and various cheeses. Protease from non -genetically modified strains of  A. oryzae  is 
already permitted for use in the other foods requested by the petitioner, except yeast extract, hydrolyzed 
yeast and plant -based foods that are not beverages. Another type of protease,  thermolysin, is permitted in 
hydrolyz ed yeast.  However, the new source organism, Aspergillus  oryzae  AT1727 was not a permitted source 
for any food enzyme in Canada.   
The results of the Food Directorate’s evaluation of available scientific data support the safety of 
carboxypeptidase D from A. oryzae  AT1727 when used as set out in the table below. Therefore, Health 
Canada has modified the List of Permitted Food Enzymes  to enable  the use of carboxypeptidase D from A. 
oryzae  AT1727 to include this enzyme f rom this source  by adding a new entry “(i)  Carboxypeptidase D ” to 
column 1 of Item  C.01,  and by adding the entries in columns 2, 3 and 4 shown below to the new entry.  For 
the definition of “Good Manufacturing Practice” set out in column 4 as a Maximum Leve l of Use, see the 
Marketing Authorization for Food Additives That May Be Used as Food Enzymes . 
 
 
1 Examples of requested bakery products include, but are not limited to, biscuits, viennoiseries, pastry, cakes, 
pancakes, tortillas, pizzas, wafers and waffles.  
2 Including breads for which compositional standards are set out in sections B.13.021 - B.13.02 9 of the Regulations.  Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Carboxypeptidase D from Aspergillus oryzae  
AT1727 in Various Foods | 3 
  
 
 
Modification to the List of Permitted Food Enzymes  
The following entr ies were added to  columns 2, 3 and 4 in  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  
C.01  (i) 
Carboxypeptidase 
D Aspergillus oryzae  
AT1727  
 (1)  
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Practice  
(2) 
Colby cheese  (2) 
Good Manufacturing 
Practice  
(3) 
Dairy -based flavouring 
preparations  (3) 
Good Manufacturing 
Practice  
(4)  
Hydrolyzed animal, milk 
and vegetable protein; 
Hydrolyzed yeast  (4) 
Good Manufacturing 
Practice  
(5) 
Spray -dried cheese 
powder  (5) 
Good Manufacturing 
Practice  
(6) 
Meat tenderizing 
preparations  (6) 
Good Manufacturing 
Practice  
(7)  
Plant -based products that 
resemble dairy products; 
Plant -based products that 
resemble dairy -based 
products; Plant -based 
products that resemble 
egg products; Plant -based 
products that resemble 
meat products including 
simulated meat products; 
Plant -based pro ducts that 
resemble poultry meat 
products including (7) 
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Carboxypeptidase D from Aspergillus oryzae  
AT1727 in Various Foods | 4 
 Item 
No. Column 1  
Additive  Column 2  
Permitted Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of Use 
and Other Conditions  
simulated poultry 
products  
(8) 
Pre-cooked (instant) 
breakfast cereals  (8) 
Good Manufacturing 
Practice  
(9)  
Unstandardized bakery 
products  (9) 
Good Manufacturing 
Practice  
(10) 
Yeast extract  (10) 
Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of carboxypeptidase D from A. 
oryzae  AT1727  for use as a food enzyme. The Directorate  considered  allergenicity, chemistry, microbiology, 
molecular biology, nutrition, and toxicology in the assessment. The results of the assessment support the 
safety of carboxypeptidase D from  A. oryzae  AT1727  for its requested uses. Therefore, Health Canada has 
enabled the requested use of carboxypeptidase D from A. oryzae  AT1727  by adding to the  List of Permitted 
Food Enzymes  the new entries shown in the above table.  
Other Relevant Information  
Food additives such as carboxypeptidase D are required to meet food -grade specifications set out in Part B of 
the Regulations , where such specifications exist,  or those set out in the  most recent  edition of the  Food 
Chemicals Codex  or the Combined Compendium of Food Additive Specifications where there are no 
specifications in Part B . The Food Chemicals Codex  is a compendium of food -grade specifications  for food 
ingredients, including food additives, published by the United States Pharmacopeial Convention. 
Specifications in the  Combined Compendium of Food Additive Specifications  and its associated General 
Specifications and Considerations for Enzyme Preparations  are prepared by the Joint FAO/WHO Expert 
Committee on Food Additives (JECFA) , both of which are  published by the Food and  Agriculture Orga nization 
of the United Nations.  
Implementation and Enforcement  
The above modification came into force May 23, 2023, the day it was published in 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.   Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Carboxypeptidase D from Aspergillus oryzae  
AT1727 in Various Foods | 5 
 Contact Information  
Health Canada's Food Directorate is committed to reviewing new scientific information on the safety in use of 
any permitted  food additive . Anyone wishing to submit an inquiry or new scienti fic information on the use of 
a permitted  food additive may do so in writing, by regular mail or electronically.  If you wish to contact the 
Food Directorate electronically  about carboxypeptidase D from A. oryzae  AT1727 , please use the words 
“carboxypeptidase D  (NOM -0201)" 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: bcs-bipc@hc -sc.gc.ca