Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Protease Obtained from  
Bacillus subtilis  Raα1102 as a Food Enzyme in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery Products   
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 Obtained from 
Bacillus subtilis  Raα1102 as a Food Enzyme in Bread, 
Flour, Whole Wheat Flour  and Unstandardized Bakery 
Products  
 
Notice of Modification –  Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0029 ] 
 
 
 July 25, 2014   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Protease Obtained from  
Bacillus subtilis  Raα1102 as a Food Enzyme in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery Products   
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 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 a food additive submission seeking approval for the use of protease obtained from Bacillus subtilis  Raα1102 as a food enzyme at a maximum level of use consistent 
with good manufacturing practice in bread, flour, whole wheat flour and unstandardized baker y 
products .    
 
This protease is intended to be used in the prevention or delay of staling after baking at mid- high 
baking temperatures and is added to the flour with the intent to improve the freshness of the 
bread during its regular shelf -life. 
 
Protease is already permitted for use in Canada as a food enzyme in bread, flour, whole wheat 
flour and unstandardized bakery products.  
 
The results of Health Canada’s evaluation of available scientific data support the safety of protease from Bacillus subtilis  Raα1102 when used as requested by the petitioner.  Therefore, 
Health Canada has modified the List of Permitted Food Enzymes
 to extend the use of protease by 
adding the entries 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 subtilis  
Raα1102  (1) Bread; Flour; Whole 
Wheat Flour  (1) Good 
Manufacturing Practice  
(2) Unstandardized 
bakery products  (2) Good 
Manufacturing Practice  
 
 
  
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Protease Obtained from  
Bacillus subtilis  Raα1102 as a Food Enzyme in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery Products   
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 protease 
obtained from Bacillus subtilis  Raα1102.  The assessment considered chemical, microbiological, 
mole cular biological, toxicological  and nutritional aspects of protease obt ained from Bacillus 
subtilis  Raα1102 when used as requested in the food additive submission.     
 
Based on the results of the safety assessment, Health Canada’s Food Directorate considers that the data support the safety of protease obtained from Bacillus subtilis  Raα1102 when used under 
the conditions of use set out in the table above.  The Department has therefore enabled the use of protease obtained from Bacillus subtilis  Raα1102 as described in that table.  
 
Other Relevant Information  
 
The Food and Drug Regulations require that all food enzymes, including protease, used as food 
additives meet the specifications for enzyme preparations set out in the most recent edition of the Food Chemicals Codex (FCC). The FCC is a compendium of standards for purity and identity of food ingredients, including food additives, which is  published by the United States 
Pharmacopeial Convention. 
 
Implementation and Enforcement  
 
The above modification came into force Ju ly 25, 2014, 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 permitted food additive, including protease from Bacillus subtilis  
Raα1102. 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 “ Protease from Bacillus 
subtilis  Raα1102" 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