Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Milk Coagulating  
Enzyme   Obtained from Rhizomucor miehei  in Cheese Analogues   
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 Milk Coagulating 
Enzyme Obtained from Rhizomucor miehei  in Cheese 
Analogues  
 
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0011 ] 
 
 
 June  6, 2013   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Milk Coagulating  
Enzyme   Obtained from Rhizomucor miehei  in Cheese Analogues   
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.  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.  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 received two food additive submissions seeking approval for the use of milk 
coagulating enzyme obtained from Rhizomucor miehei  (Cooney and Emerson) (previous name: 
Mucor miehei  (Cooney and Emerson)) as a milk coagulating enzyme at a level of use consistent 
with Good Manufacturing Practice in products that are similar to cheese but in which milk fat 
has been replaced with vegetable oil. These products are referred to as cheese analogues.  
 
Milk coagulating enzyme from R. miehei (Cooney and Emers on) is already permitted for use in 
Canada as a food enzyme in various types of cheese, sour cream, dairy -based flavouring 
preparations and hydrolyzed animal, milk and vegetable protein.  
 
The results of Health Canada’s evaluation of available scientific da ta support the safety of milk 
coagulating enzyme from R. miehei  (Cooney and Emerson) when used as set out in the table 
below.  Therefore, Health Canada has modified the List of Permitted Food Enzymes  to extend the 
use of milk coagulating enzyme obtained from this source organism  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 (Cooney 
and Emerson) 
(previous 
name:  Mucor 
miehei  (Cooney 
and Emerson))  (4)  
Cheese analogues  (4) 
Good Manufacturing Practice  
 
 
 
 
  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Milk Coagulating  
Enzyme   Obtained from Rhizomucor miehei  in Cheese Analogues   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of milk coagulating 
enzyme from R. miehei (Cooney and Emerson).  The assessment considered microbiological, 
toxicological, and technical aspects of milk coagulating enzyme obtained from R. miehei when 
used as described above.     
 
Milk coagulating enzyme obtained from R. miehei has a sufficient to xicological data set to 
support its safety.  In addition, this enzyme has a history of safe use in the Canadian food supply 
in the manufacture of cheese. The Joint FAO/WHO Expert Committee for Food Additives 
(JECFA) in 1974 established an acceptable daily intake (ADI) of ‘not specified’ for microbial 
rennet (i.e., milk coagulating enzyme) from Mucor miehei (whose current name is Rhizomucor 
miehei ).  This designation is assigned to substances that have a very low toxicity and, on the 
basis of available data and the total dietary intake, do not pose a health hazard.  Health Canada 
(1974) concurred with this conclusion and suggested that the enzyme could be used at a level 
consistent with Good Manufacturing Practice.  
 
Based on the results of the safety assessm ent, Health Canada’s Food Directorate considers that 
the data support the safety of milk coagulating enzyme obtained from R. miehei  (Cooney and 
Emerson) when used under the conditions of use set out in the table above.  The Department has 
therefore enabled  the use of milk coagulating enzyme obtained from this source organism as 
described in the above table.  
 
Implementation and Enforcement  
 
The abov e modification came into force on June 6, 201 3, 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 foo ds.  
 
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 milk coagulating enzyme obtained from R. 
miehei . Anyone wishing to submit new scientific 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 electronically, please use the words " Milk Coagulating Enzyme 
obtained from R. miehei " in the subject line of your e -mail.  
 
Bureau of Chemical Safety , 251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C , Ottawa, Ontario K1A 0L2  
E-mail: bcs-bipc@hc -sc.gc.ca