Notice o f Modification to the List of Permitted 
Food Enzymes  to Enable  the Use of alpha-Amylase 
from Bacillus subtilis AR-651 in Bread, Flour , 
Whole Wheat Flour and Unstandardized Bakery 
Products  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NO M/ADM-0200 
April  27, 2023 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of alpha -Amylase from Bacillus subtilis  AR-651 in 
Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products  | 2 
 Summary  
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by th e 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 authorize  a 
new additive , or a new source  or a new condition of use for an already permitt ed food additive , by filing a 
food additive submission with the Department's Food Directorate. Health Canada uses this premarket 
authorization  process to determine whether the scientific data suppo rt 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 authorization  for the use of 
alpha -amylase  (α-amylase) from Bacillus subtilis  AR-651 in bread, flour, whole wheat flour, and 
unstandardized bakery products .  The requested maximum level of use for this  food enzyme is Good 
Manufacturing Practice.   
α-Amylase from other sources is already permitted for use in the foods requested by the petitioner. 
However, B. subtilis  AR-651 was not a permitted source organism for any food enzyme in Canada.   
The results of the Food Directorate’s evaluation of availabl e scientific data support the safety of α-amylase  
from B. subtilis  AR-651 when used as requested by the petitioner . Therefore, Health Canada has modified the 
List of Permitted Food Enzymes  to enable  the use of α-amylase  from B. subtilis  AR-651 by adding th is new 
source organism  in Column 2 of Item A.1  in the list, as shown in the table below  (in bold font in this Notice to 
illustrate the change ). For the definition of “Good Manufacturing Practice” set out in column 4 as a Maximum 
Level of Use, see  the Marketing Authorization for Food Additives That May Be Used as Food Enzymes . 
 
Modification to the  List of Permitted Food Enzymes  
The new entry shown below  in column 2 ( bold font not used in the List) , was added 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  
A.1 Amylase  Bacillus subtilis NBA (DS 
68703); Bacillus subtilis  
AR-651 (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Practice  
(2) 
Unstandardized bakery 
products  (2) 
Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorat e completed a premarket safety a ssessment of α-amylase  from B. subtilis  AR-
651 for use as a food enzyme  in bread, flour, whole wheat flour and unstandardized bakery products . The 
Directorate considered allergenicity, chemistry, microbiology, molecular b iology, nutrition, and toxicology in 
the assessment. The results of the assessment support  the safety of α-amylase  from B. subtilis  AR-651 for its Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of alpha -Amylase from Bacillus subtilis  AR-651 in 
Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products  | 3 
 requested uses.  Therefore, Health Canada  has enabled the requested uses of α-amylase  from B. subti lis AR-
651 by adding to the List of Permitted Food Enzymes  the new entr y shown  in the above table.  
Other Relevant Information  
Food additives such as α-amylase  are required to meet food -grade specifications set out in Part B of the 
Regulations , where such specifications exist,  or those 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 food -grade specifications  for food ingredients, including food additives, publishe d by the 
United States Pharmacopeial Convention. 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 Committ ee 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 April 27 , 2023, 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 new scientific information on the safety in use of 
any permitted  food additive . Anyone wishing to submit an inquiry or new scienti fic information on the use of 
a permitted food additive may do so in writing, by r egular mail or electronically. If you wish to contact the 
Food Directorate electronically  about α-amylase  from B. subtilis  AR-651, please use the words 
“alpha -amylase  (NOM -0200)" 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: bcs-bipc@hc -sc.gc.ca