 
  
Notice of Modification to the List of 
Permitted Food Enzymes  to Enable  the 
Use of M altogenic  alpha -Amylase from 
Bacillus subtilis  ROM in Bread, Flour , 
Whole Wheat Flour , and 
Unstandardized Bakery P roducts  
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0204 
June  09, 2023 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Maltogenic alpha -Amylase from Bacillus subtilis  
ROM in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery Products  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 Heal th Canada approve a 
new additive , or 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 
authorization  process to determine whether the scientific data support the safety of food additives when 
used under specified conditions in food s sold in Canada.  
Health Canada’s Food Directorate received a food additive submission s eeking authorization  for the use of 
maltogenic alpha -amylase ( α-amylase ) from Bacillus subtilis ROM  as an enzyme in bread, flour, whole wheat 
flour, and unstandardized bakery products . The requested maximum level of use for this food enzyme is 
Good Manufacturing Practice.  Maltogenic α -amylase is used during baking to partially degrade amylopectin 
which, if not treated enzymatically, would cause staling of the baked produ ct due to recrystallization . 
Maltogenic α -amylase from other sources is already permitted in bread, flour, whole wheat flour, and 
unstandardiz ed bakery products in Canada. However, t he new source organism, B. subtilis  ROM, was not a 
permitted source for any food enzyme in Canada . 
The results of the Food Directorate’s evaluation of available sci entific data support the safety  of maltogenic 
α-amylase from B. subtilis ROM  when used as set out in the table  below . Therefore, Health Canada has 
modified the List of Permitted Food Enzymes  to enable  the use of maltogenic α -amylase from B. subtilis ROM  
by adding the new source organism “Bacillus subtilis  ROM” to the first group of source organisms  in Column 2 
of Item A.2(i) in the list, as shown in the table below. For the definition of “Good Man ufacturing 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  
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; 
Bacillus subtilis 
ROM ; 
Saccharomyces 
cerevisiae  M17906  (1) 
Bread; Flour; Whole 
wheat flour  (1) 
Good Manufacturing 
Prac tice 
(2) 
Unstandardized bakery 
products  (2) 
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable  the Use of Maltogenic alpha -Amylase from Bacillus subtilis  
ROM in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery Products  3 
 Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment  of maltogenic α -amylase from 
Bacillus subtilis ROM  for use as a food enzyme. The Directorate considered  allergenicity, chemistry, 
microbiology, molecular biology, nutrition, and toxicology in the assessment. The results of the assessment 
support the safety of maltogenic α -amylase from B. subtilis ROM  for its requested uses. Therefore, the 
Department has enabled the requested uses of maltogenic α -amylase from B. subtilis ROM  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 Specifications where there are no 
specifications in Part B . The Food Chemicals Codex  is a compendium of food - grade  specifications for food 
ingredients, including food additives, published by the United States Pharmacopeial Convention. 
Specifications in the  Combined Compendium of Food Additive Specifications  and its associa ted 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 a nd Enforcement  
The above modification came into force June  09, 2023, 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 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 additive may do so in writing, by regular mail  or electronically.  If you wish to contact the Food 
Directorate electronically  about maltogenic α -amylase from Bacillus subtilis ROM , please use the words 
“maltogenic α -amylase  (NOM -0204)" 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  
 