Notice of Modification to the List of 
Permitted Food Enzymes  to Enable  the 
Use of beta -Amylase from Priestia flexa 
AE-BAF in Glutinous Rice -based Cakes  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0199 
March  28, 2023 
 Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of beta -Amylase from Priestia flexa  AE-BAF in 
Glutinous Rice -based Cakes  | 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 s ource  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 support th e 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 
beta -amylase (β-amylase ) from Bacillus flexus  AE-BAF as a food enzyme  in mochi and dango.1 The requested 
maximum level of use for this food enzyme is Good Manufacturing Practice.  
β-amylase from B. flexus  AE-BAF is already  permitted for use in bread, flour, whole wheat flour, 
brewers’  mash, starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids 
(dried glucose syrup) or maltose, and unstandardized bakery products. This submission is a request to extend 
the use of this enzyme from this already -permitt ed source to mochi and dango.  
The results of the Food Directorate’s evaluation of available scie ntific data support the safety and efficacy of 
β-amylase from B. flexus  AE-BAF when used as requested by the petitioner . Therefore, Health Canada has 
modified the List of Permitted Food Enzymes  to enable the use of β-amylase from B. flexus  AE-BAF by adding 
the entry shown in the table below in Columns 3 and 4 of item A.1(i) to the list  (bold  font not used in the list ). 
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 : 
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 (i) β-
amylase  Priestia flexa  AE-BAF 
(previous name:  
Bacillus flexus  AE-
BAF) (5) 
Glutinous rice -based 
cakes  (5) 
Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorat e completed a premarket safety and efficacy  assessment of β-amylase from 
B. flexus  AE-BAF for use as food enzyme  in mochi and dango . The Directorate  conclu ded that information 
related to allergenicity, chemistry, microbiology, molecular b iology, nutrition , and toxicology  support s the 
 
1 Mochi was  described as a type of Japanese rice cake made by pounding and kneading steamed rice, and dango as 
a type of Japanese rice cake made by steaming or boiling a mixture of water and rice flour that has been kneaded 
and rolled.  Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of beta -Amylase from Priestia flexa  AE-BAF in 
Glutinous Rice -based Cakes  | 3 
 safety of β -amylase from B. flexus  AE-BAF for  its requested uses and technical information indicates the 
enzyme is effective for its intended purposes .  Therefore, Health Canada  has enabled the requested uses of 
β-amylase from B. flexus  AE-BAF 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 β-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. 
Specificati ons 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 March  28, 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 informati on 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 
Directora te electronically about beta -amylase from B. flexus  AE-BAF,  please use the words “beta -amylase  
(NOM -0199)" 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