Notice of Modification to the List of 
Permitted Food Enzymes  to Enable the 
Use of β-amylase from Bacillus flexus  
AE-BAF in Various F oods  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0161 
February  9, 2021 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of β-amylase from Bacillus flexus  AE-BAF in Certain 
Foods – Reference Number: NOM/ADM -0161| 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 Pe rmitted 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 foo d 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 β-
amylase from Bacillus flexus  AE-BAF as a food enzyme  in various foods: brewers’ mash  used in the production 
of ale, beer, light beer, malt liquor, porter, stout ; bread,  flour,  whole wheat flour;  starch used in the 
production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or maltose ; and 
unstandardized bakery products . The food enzyme is intended to be used at a level consistent with Good 
Manufacturing Practice . 
β-amylase is a subtype of amylase and barley malt is a permitted source of this enzyme.  β-amylase  from 
barley malt  is already permitted for use in Canada as a food enzyme  in the manufacture of all the foods of 
interest to the petitioner other than  brewers’ mash .  
The results of the Food Directorate’s evaluation of available scientific data support the safety  and efficacy  of 
β-amylase from B. flexus  AE-BAF when used as set out in the table below.  Therefore, Healt h Canada has 
modified the List of Permitted Food Enzymes  to enable  the use of β-amylase  from B. flexus  AE-BAF by adding 
a new entry “(i) β-amylase ” to column 1 for Item No. A.1 and adding the entries in columns 2, 3 and 4 shown 
below to the new entry (i) of Item No. A.1 in the List.  
 
Modification to the  List of Permitted Food Enzyme s 
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  Bacillus flexus  AE-
BAF (1) 
Bread; Flour; Whole wheat 
flour  (1) 
Good Manufacturing Practice  
(2) 
Brewers' Mash  (2) 
Good Manufacturing Practice  
(3) 
Starch used in the 
production of dextrins, 
dextrose, glucose (glucose 
syrup), glucose solids (dried 
glucose syrup) or maltose  (3) 
Good Manufacturing Practice  
(4) 
Unstandardized bakery 
products  (4) 
Good Manufacturing Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of β-amylase from Bacillus flexus  AE-BAF in Certain 
Foods – Reference Number: NOM/ADM -0161| 3 
 Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of β-amylase from B. flexus  AE-
BAF for use as a food enzyme .  The assessment conclud ed that information related to allergenicity, 
chemistry, microbiology, molecular biology, nutrition, and toxicology supports the safety of  β-amylase from 
B. flexus  AE-BAF for its requested uses.  Therefore, the Department has enabled the requested uses of β-
amylase from B. flexus  AE-BAF by adding to t he List of Permitted Food Enzymes  the new entr ies shown in the 
above table.  
Other Relevant Information  
The Food and Dru g Regulations  require that food additives such as β-amylase that do not have food -grade 
specifications set out in Part B of the Regulations meet the food -grade specifications 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. The Combined 
Compendium of F ood 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) and 
published by the Food and Agriculture Organization of the Unit ed Nations.  
Implementation and Enforcement  
The above modification came into force February  9, 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 β-amylase from B. flexus  AE-BAF.  Anyone wishing to submit new 
scientific information on the use of this ad ditive or to submit any inquiries may do so in writing, by regular 
mail or electronically.  If you wish to contact the Food Directorate electronically, please use the words " β-
amylase  (NOM -0161)" 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