 
  
Notice of Modification to the List of Permitted 
Food Enzymes  to Enable  the Use of 
Maltogenic α-Amylase from Three Sources  in 
Bread, Flour , Whole Wheat Flour and 
Unstandardized Bakery  Products  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0175  
October  25, 2021 
 Notice of Modification to the List of Permitted Food Enzymes to Enabl e the Use of Maltogenic α -Amylase  from Three Sources in 
Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products  – Reference Number: NOM/ADM -0175| 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 Cana da’s Food Directorate received three  food additive submission s seeking approval for the use of 
maltogenic alpha - (α-) amylase from  Bacillus licheniformis  HyGe750n6,  B. subtilis  RF13018 , and 
Saccharomyces cerevisiae  M17906  in bread, flour, whole wh eat flour, and unstandardized bakery products . 
This food enzyme is intended to be used at a maximum level consistent w ith 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 
petitioners . The new source organism s, B. licheniformis  HyGe750n6 , B. subtilis  RF13018 , and S. cerevisiae  
M17906 , were not permitted source s 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  HyGe750n6,  B. subtilis  RF13018 , and S. cerevisiae  M17906  when used as set 
out in the table below . Therefore, Hea lth Canada has modified the List of Permitted Food Enzymes  to extend  
the use of maltogenic amylase  (specifically, maltogenic α -amylase)  to include this enzyme from these three 
sources by adding a new  entry  “(i) α-Amylase (maltogenic) ” to column 1 of Item A.2 and adding the entries  in 
columns 2, 3 and 4 shown below  to the new entry (i) of Item No. A.2 in the List . 
 
Consequential Modification  
The previous list entries for maltogenic amylase from B. licheniformis  MDT06 -221, B. subtilis BS154,  and B. 
subtilis RF12029  did not specify the alpha  configuration  of this enzyme .2 Since the List is modified to include  a 
new separate subitem A.2(i) specifically for maltogenic α-amylase , the sources B. subtilis BS154 and  B. subtilis 
RF12029  were removed from their previous  list entry for maltogenic amylase and grouped by alphabetical 
order with the new sources B. licheniformis HyGe750n6,  B. subtilis RF13018 and  S. cerevisiae  M17906  under 
new subitem A.2(i)  for maltogenic α-amylase  in the List of Permitted Food Enzymes , as shown below . A 
separate  entry was created under subitem A.2(i) of this List for the source B. licheniformis  MDT06 -221, as 
shown below , because maltogenic α-amylase from this source , but not the other sources, is also listed for use  
in pasta . 
 
                                                             
1 See the definition of Good Manufacturing Practice in the Marketing Authoriz ation for Food Additives That May Be 
Used as Food Enzymes . 
2 The sources  B. subtilis BS154,  B. subtilis RF12029 and B. licheniformis  MDT06 -221 were previously listed under 
item A.2 Amylase (maltogenic ) the day before the modification for  B. licheniformis HyGe750n6,  B. subtilis RF13018 
and S. cerevisiae  M17906 , which is the subject of the present NOM, was made . Notice of Modification to the List of Permitted Food Enzymes to Enabl e the Use of Maltogenic α -Amylase  from Three Sources in 
Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products  – Reference Number: NOM/ADM -0175| 3 
 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 
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  
Bacillus licheniformis  
MDT06 -221 (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good manufacturing 
practice  
(2) 
Pasta  (2) 
Good manufacturing 
practice  
(3) 
Unstandardized bakery 
products  (3) 
Good manufacturing 
practice  
Rationale  
Health Canada’s Food  Directorate completed a premarket safety assessment of maltogenic α-amylase from  
each of  B. licheniformis  HyGe750n6,  B. subtilis  RF13018 , and S. cerevisiae  M17906 , for use as  a food enzyme 
in the foods of interest to the petitioner s. The Department  conclud ed that information related to 
allergenicity, chemistry, microbiology, molecular b iology, and toxicology supports the safety of maltogenic α-
amylase from these sources  for it s 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  HyGe750n6,  B. subtilis  RF13018 , and S. cerevisiae  M17906  by adding to the  
List of Permitted Food Enzymes  the new entr ies shown in the above table.  
Other Relevant Inform ation  
Food additives such as maltogenic α-amylase  are required to meet food -grade specifications set out in Part B 
of the Regulations 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 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 Additiv e 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.  Notice of Modification to the List of Permitted Food Enzymes to Enabl e the Use of Maltogenic α -Amylase  from Three Sources in 
Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products  – Reference Number: NOM/ADM -0175| 4 
 Implementation and Enforcement  
The above modification came into force October 25, 2021, 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  HyGe750n6,  B. subtilis  
RF13018 , and S. cerevisiae  M17906 . Anyone wishing to submit an inquiry or new scienti fic information on the 
use of this additive  may do so in writing, by regular mail or electronically. If you wish to c ontact the Food 
Directorate electronically, please use the words " alpha -amylase  maltogenic  (NOM -0175 )" 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: hc.bcs -bipc.sc@canada.ca  