Notice of Modification to the List of 
Permitted Food Enzymes  to Enable the 
Use of Milk C oagulating Enzyme  from 
Rhizomucor miehei  CBS 146319  in 
Yogurt  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0173 
September  17, 2021 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Milk Coagulating Enzyme from  Rhizomucor miehei  
CBS 146319  in Yogurt  – Reference Number: NOM/ADM -0173| 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.  
Healt h Canada’s Food Directorate received a food additive submission seeking approval for the use of  milk 
coagulating enzyme from Rhizomucor miehei  CBS 146319  in the manufacture of yogurt at a maximum level 
consistent with Good Manufacturing Practice (GMP).1  
Milk coagulating enzyme from wild -type R. miehei  (Cooney and Emerson) is  already permitted for use in 
Canada in the manufacture of various standardized cheeses, sour cream, dairy -based flavouring preparations, 
and hydrolyzed animal, milk and vegetable protein. Milk coagulating enzyme from other microbial sources is 
already permitted in some of these fo ods. However, milk coagulating enzyme  from any source has not been 
permitted in the manufacture of yogurt.  
The results of the Food Directorate’s evaluation of available scientific data support the safety of  milk 
coagulating enzyme  from R. miehei  CBS 146319  for its requested use. Therefore, Health Canada has modified 
the List of Permitted Food Enzymes  to enable  the use of  milk coagulating enzyme from R. miehei  CBS 146319  
in the manufacture of yogurt by adding the entry 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  
M.1 Milk coagulating 
enzyme  Rhizomucor miehei  
CBS 146319  Yogurt  Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorate completed a  premarket safety assessment of milk coagulating enzyme 
from R. miehei  CBS 146319  for use as a food enzyme in the manufacture of yogurt. The Department  
concluded that information related to allergenicity , chemistry , microbiology, molecular biology, nutrition,  
and toxicology  supports the safety of milk coagulating enzyme from R. miehei  CBS 146319  for its requested 
                                                             
1 See the definition of G ood Manufacturing Practice  in the Marketing Authorization for Food Additives That May Be 
Used as Food Enzymes . 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Milk Coagulating Enzyme from  Rhizomucor miehei  
CBS 146319  in Yogurt  – Reference Number: NOM/ADM -0173| 3 
 use. Therefore, the Department has enabled the requested use of milk coagulating enzyme from R. miehei  
CBS 146319  by adding to the List of Permitted Food Enzymes  the new entr y shown in the above table.  
Other Relevant Information  
The Food and Drug Regulations  require that food additi ves such as milk coagulating enzyme that do not have 
food -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 compendium of standards for purity and identity for food 
ingredients, including food additives, published by the United S tates Pharmacopeial Convention. The 
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 September  17, 2021, 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 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 permitted  food additive, including milk coagulating enzyme from R. miehei  CBS 146319 . Anyone wishing 
to submit new scienti fic information on the use of this additive or to submit inquiries on this modification 
may do so in writing, by regular mail or electronically. If you wish to contact t he Food Directorate 
electronically, please use the words " milk coagulating enzyme  (NOM -0173)" 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