Notice of Modification to the List of 
Permitted Food Enzymes to Enable the Use 
of Maltogenic α-Amylase from Bacillus 
licheniformis  HyGe767n2  in Bread, Flour , 
Whole Wheat Flour and Unstandardized 
Bakery Products  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0178  
January  19, 2022 
 Notice of Modification to the List of Permitted Food Enzymes to Enabl e the Use of Maltogenic α -Amylase  from Bacillus licheniformis  
HyGe767n2  in Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products  – Reference Number: NOM/ADM -0178| 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 Per mitted 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 , a new source  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 Cana da’s Food Directorate received a food additive submission seeking approval  for the use of 
maltogenic alpha - (α-) amylase from Bacillus licheniformis  HyGe767n2 in bread,  flour, whole wheat flour, and 
unstandardized bakery products . This food enzyme is intended to be used at a maximum level consistent 
with Good Manufacturing Practice .1 The purpose of using maltogenic α -amylase is to delay the staling of 
baked goods.   
Maltogenic α -amylase from other sources is already permitted in the same foods of interest to the petitioner . 
The new source organism B. licheniformis  HyGe767n2  was not a permitted source for any food enzyme in 
Canada.  
The results of the Food Directorate’s evaluation of available scientific data support the safety of maltogenic 
α-amylase from B. licheniformis  HyGe767n2  when used as requested by the petitioner . Therefore, Health 
Canada has modified the List of Permitted Food Enzymes  to extend  the use of maltogenic α -amylase  to 
include  this new source organism for this  enzyme by adding the entry shown below (highlighted in bold font  
in this Notice only)  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  
A.2 (i) α-
Amylase 
(maltogenic)  Bacillus licheniformis 
HyGe750n6; Bacillus 
licheniformis 
HyGe767n2;  Bacillus 
subtilis BS154;  Bacillus 
subtilis RF12029;  
Bacillus subtilis 
RF13018; 
Saccharomyces 
cerevisiae  M17906  (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good manufacturing 
practice  
(2) 
Unstandardized bakery 
products  (2) 
Good manufacturing 
practice  
 
                                                             
1 See the definition of Good Manufacturing Practice in the Marketing Authoriz ation for Food Additives That May Be 
Used as Food Enzymes . Notice of Modification to the List of Permitted Food Enzymes to Enabl e the Use of Maltogenic α -Amylase  from Bacillus licheniformis  
HyGe767n2  in Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products  – Reference Number: NOM/ADM -0178| 3 
 Rationale  
Health Canada’s Food  Directorate completed a premarket safety assessment of maltogenic α -amylase from 
B. licheniformis  HyGe767n2  for use as  a food enzyme in the food s of interest to the petitioner . The 
Department  conclud ed that information related to allergenicity, chemistry, microbiology, molecular b iology, 
and toxicology supports the safety of maltogenic α-amylase from this source for its requested uses , and 
technical information indicates the enzyme is effective for its intended purpose . Therefore, the Department 
has enabled the requested uses of maltogenic α -amylase from B. licheniformis  HyGe767n2  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 maltogenic 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 S pecifications . 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. 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 Committee 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 January  19, 2022, 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, including  maltogenic α -amylase from B. licheniformis  HyGe767n2 . Anyone 
wishing to submit an inquiry or new scienti fic information on the use of this addi tive may do so in writing, by 
regular mail or electronically. If you wish to contact the Food Directorate electronically, please use the words 
"alpha -amylase  maltogenic  (NOM -0178 )" 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