Notice of Modification to the List of 
Permitted Food Enzymes  to Enable the 
Use of Chymosin from Aspergillus niger 
DSM 32805  in Certain Dairy -based 
Foods  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0165 
April 26 , 2021 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Chymosin from Aspergillus niger  DSM 32805 in 
Certain Dairy-based Foods  – Reference Number: [NOM/ADM -0165]| 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 Permitted 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 f ood 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 
chymosin from Aspergillus niger DSM 32805  in cheese and fermented milk production  at a level consistent 
with Good Manufacturing Practice . The food enzyme is  intended to be used in the production of cheddar 
cheese, (naming the variety) cheese, cottage cheese, cream cheese, cream cheese with (naming the added 
ingredients), cream cheese spread, cream cheese spread with (naming  the added ingredients), sour cream,  
unstandardized milk -based dessert preparations  (e.g. custards, puddings, frozen yogurt, and flan) , kefir, 
quark, and yogurt.  
Chymosin and chymosin A from other sources are already permitted for use in the foods requested by the 
petitioner, except for kefir, quark, and yogurt. Chymosin B from Kluyveromyces lactis  CIN is already permitted 
for use in all of the foods requested by the petitioner.  However, A. niger  DSM 32805 is not a permitted 
source for any food enzyme in Canada.  
 
The results of the Food Directorate’s evaluation of available sci entific data support the safety of chymosin 
from A. niger DSM 32805 when used as requested by the petitioner.  Therefore, Health Canada has modified 
the List of Permitted Food Enzymes  to enable  the use of chymosin from A. niger  DSM 32805 by adding the 
new entr ies shown below to the list. 
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  
C.3 (iii) 
Chymosin  Aspergillus niger  
DSM 32805  (1)  
Cheddar cheese; (naming the 
variety) Cheese; Cottage cheese; 
Cream cheese; Cream cheese with 
(naming the added ingredients); 
Cream cheese spread; Cream 
cheese spread with  (naming the 
added ingredients); Sour cream   (1) 
Good Manufacturing 
Practice  
(2) 
Kefir; Quark; Yogurt  (2) 
Good Manufacturing 
Practice  
(3)  
Unstandardized milk -based 
dessert preparations  (3) 
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Chymosin from Aspergillus niger  DSM 32805 in 
Certain Dairy-based Foods  – Reference Number: [NOM/ADM -0165]| 3 
 Rationa le 
Health Canada’s Food Directorate completed a premarket safety assessment of chymosin from A. niger  DSM 
32805 for use as a food enzyme in certain milk - and dairy -based  foods . The assessment concluded that 
information related to allergenicity , chemistry, microbiology  and molecular biology , nutrition , and toxicology  
supports the safety of chymosin from A. niger  DSM 32805  for its requested u ses. Therefore, the Departmen t 
has enabled the requested use  of chymosin from A. niger  DSM 32805  by adding to the  List of Permitted Food 
Enzymes  the new entries shown in the above table.  
Other Relevant Information  
The Food and Drug Regulations  require that food additives such as chymosin  that do not have food -grade 
specifications set out in Part B of the Regulations meet the food -grade specificatio ns 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 compendium of standards for purity and identity for food ingredients, 
including food additives, pub lished by the United States Pharmacopeial Convention. 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 Ad ditives (JECFA) and 
published by the Food and Agriculture Orga nization of the United Nations.  
Implementation and Enforcement  
The above modification came into force April 26, 2021, 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 new scientific information on the safety in use of 
any food additive, including chymosin from A. niger  DSM 32805 .  Anyone wishing to submit new scienti fic 
information on the use of this additive or to submit inquiries may do so in writing, by regular mail or 
electronically.  If you wish to contact the Food Directorate electronically, please use the wor ds "Chymosin  
(NOM -0165)" in the subject line of your e -mail.  
Bureau of Chemical Safety, Food D irectorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca