Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protease from  
Bacillus licheniformis  S10-34zEK4 in the Manufacture of Hydrolyzed Animal, Milk and Vegetabl e Protein   
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 Protease from Bacillus 
licheniformis  S10-34zEK4 in the Manufacture of 
Hydrolyzed Animal, Milk and Vegetable Protein  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0068] 
 
Febr uary  26, 2016   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protease from  
Bacillus licheniformis  S10-34zEK4 in the Manufacture of Hydrolyzed Animal, Milk and Vegetabl e Protein   
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 and published on Health Canada’s website.  A petitioner 
can request that Health Canada approve a n ew 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 pre -market approval process to determine whether the 
scientific data support t he safety of food additives when used under specified conditions in foods 
sold in Canada.  
Health Canada received a food additive submission seeking approval for the use of protease from 
Bacillus licheniformis  S10-34zEK4 in the manufacture of hydrolyzed animal, milk and vegetable 
protein.    
 
Protease from B. licheniformis  (Cx) is already permitted for use in the manufacture of 
hydrolyzed anima l, milk and vegetable protein. However, B. licheniformis  S10-34zEK4,  which  
is a strain of B. licheniformis  that was developed to be a high yielding protease production strain, 
has not yet been approved as a permitted source of any food enzyme.  
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
protease obtained from B. licheniformis  S10-34zEK4 when used as requested by the petitioner.  
Therefore, Health Canada has modified the List of Permitted Food Enzymes  to allow this 
microorganism to be used as a source of protease 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  
P.6 Protease  Bacillus licheniformis 
S10-34zEK4  (1) Hydrolyzed animal, 
milk and vegetable protein  
 (1) Good 
Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of the requested use 
of protease obtained from B. licheniformis  S10-34zEK4 . The assessment considered 
microbiologi cal, toxicological, nutritional  and chemical aspects of this additive, and found that 
the requested uses are acceptable from a food safety perspective. Therefore, the Department has  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protease from  
Bacillus licheniformis  S10-34zEK4 in the Manufacture of Hydrolyzed Animal, Milk and Vegetabl e Protein   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 enabled the requested uses of protease obtained from B. licheniformis  S10-34zEK4 by modifying 
the List of  Permitted Food Enzymes  as described in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations require that food additives, such as protease from 
B. licheniformis  S10-34zEK4, which do not have specifications set out in the Regulations, meet 
the food -grade specifications set out in the most recent edition of the Food Chemicals Codex 
(FCC). The FCC is a compendium of standards for purity and identity for food ingredi ents, 
including food additives, which is published by the United States Pharmacopeial Convention.   
 
Implementation and Enforcement  
 
The above modification came into force Febr uary 26, 2016 , 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 information on 
the safety in use of any food additive, including protease . Anyone wishing to submit n ew 
scientifi c information on the use of this food  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 word “ protease ” 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 0L2  
E-mail:  bcs-bipc@hc -sc.gc.ca