Notice of Modification to the List of Permitted Food Enzymes  to Enab le the Use of  
Maltogenic alpha -Amylase from Bacillus subtilis  RF12029 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 Maltogenic 
alpha -Amylase  from Bacillus subtilis RF12029  in 
Bread, Flour, Whole Wheat Flour and 
Unstandardized  Bakery Products  
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: [NO M/ADM-0125] 
November 8, 2018 Notice of Modification to the List of Permitted Food Enzymes  to Enab le the Use of  
Maltogenic alpha -Amylase from Bacillus subtilis  RF12029 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  (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 approve a new additive or a new condition of use for an already 
approved food additive by filing a fo od 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 ’s Food Directorate  received a food additive submission seeking approval for the 
use of maltogenic alpha -amylase from Bacillus subtilis RF12029  as a food enzyme in bread, 
flour, whole wheat flour and unstandardized bakery products , at level s of use  consistent with 
Good Manufacturing Practice  (GMP) . The purpose for using maltogenic alpha -amylase  in these 
foods  is largely to reduce the rate of staling of bread and other bakery products . 
 
Maltogenic alpha -amylase is already permitted for use in Canada as a  food enzyme in bread, 
flour, whole wheat flour and unstandardized bakery products . However,  B. subtilis RF12029  has 
not previously been permitted as a source for food enzymes in Canada.  
 
The Food Directorate determ ined that information related to the safety of  maltogenic alpha -
amylase from B. subtilis RF12029  supports it s use in the foods of interest.  Therefore, Health 
Canada has modified the List of Permitted Food Enzymes  to enable the use of maltogenic alpha -
amylase from this source  by adding the name of the s ource to Column 2 of the existing entry for 
Amylase (maltogenic) \. The new source has been added immediately following the already -
permitted source Bacillus subtilis BS154 , as shown in the table below.  
 
Modification to the List of Permitted Food Enzym es 
 
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.2 Amylase 
(maltogenic)  Bacillus subtilis 
BS154 ; Bacillus 
subtilis RF12029  (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 Enab le the Use of  
Maltogenic alpha -Amylase from Bacillus subtilis  RF12029 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 F ood Directorate completed a pre market safety assessment of the requested 
uses of  maltogenic alpha -amylase from B. subtilis RF12029 .  The assessment  concluded that 
information related to chemistry, microbiology, molecular biology, nutrition, toxicology  and 
allergenicity  supports the safety of maltogenic alpha -amylase from this source for its requested 
uses. Therefore, Health Canada  has enabled the requested uses of maltogenic alpha -amylase 
from B. subtilis RF12029  by modifying the List of Permitted Food Enzymes  as shown  in the 
above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as maltogenic alpha -amylase 
that do not have food -grade specifications set out in Part B of the Regulations meet the most 
recent food -grade specifications set out in 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 States Pharmacopeial Convention . The Combined Compendium of Food Additive 
Specifications  and its associated  General Specifications  and Considerations for Enzyme 
Preparations  are both prepared by the Joint FAO/WHO Expert Committee on Food Additives 
(JECFA)  and published by the Food and Agriculture Organization of the United Nations.  
  
Implementation and Enforcement  
 
The above modifica tion came into force November  8, 2018 , 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 Drugs 
Act and its associated regulations with respect to foods.  
 
Contact Information  
 
Health Canada ’s Food Directorate is committed to reviewing any new scientific info rmation on 
the safety in use of any food additive, including  maltogenic alpha -amylase from B. subtilis 
RF12029 . Anyone wishing to submit new scienti fic 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 electro nically, please use the words " maltogenic amylase  (NOM -
0125)" 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: hc.bcs -bipc.sc@canada.ca