Notice of Modification to the List of Permitted Food Enzymes  to Enable the U se of Bacillus amyloliquefaciens  as a S ource  
Organism for Food Enzymes that are Currently Permitted to be S ourced from Bacillus subtilis   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     1 
  
Notice of Modification to the List of Permitted Food 
Enzymes  to Enable the Use of Bacillus amyloliquefaciens  
as a Source Organism for Food Enzymes that are 
Currently Permitted to be Sourced from Bacillus subtilis  
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0053] 
 
 
 July 15, 2015   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the U se of Bacillus amyloliquefaciens  as a S ource  
Organism for Food Enzymes that are Currently Permitted to be S ourced from Bacillus subtilis   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     2 Summary  
 
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by the 
Minister of Health and the Food and Drug 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 MA’s and publis hed on Health Canada’s 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 food additive submission with the  Department's Food 
Directorate.  Health Canada uses this premarket approval proc ess to determine whether the 
scientific data support the safety of food additives when used under specified conditions in foods 
sold in Canada.  
 
Food enzymes permitted for use as food additives are set out in the List of Permitted Food 
Enzymes  on Health Canada’s website. The List also identifies the source(s) from which permitted 
enzymes may be obtained, the food(s) to which they may be added, and their maximum level(s) 
of use  in those foods.  
 
Health Canada received a request from a food enzyme industry association to revise the List of 
Permitted Food Enzymes  to recognize a taxonomic change that occurred within the genus 
Bacillus . The microorganism that was once classified as Bacillus subtilis  has since been 
recognised as comprising two microorganisms, now identified as Bacillus amyloliquefaciens  and 
Bacillus subtilis . These two microorganisms are considered to be closely related but 
taxonomically distinct species within the gen us Bacillus .  
 
Bacillus subtilis  has been a permitted source for a number of food enzymes since at least the late 
1970s, well before the taxonomic recognition of B. amyloliquefaciens  as a species distinct from 
B. subtilis in the late 1980s. It is possible, then, that enzyme source organisms identified as B. 
subtilis  and which were approved in Canada prior to broad adoption throughout the food industry 
of the updated taxonomic classification would, if evaluated under the cur rent taxonomic 
classification of the genus Bacillus , be classified as B.  amyloliquefaciens .  
 
In the interest of consistency between current taxonomic practice and the Lists of Permitted Food 
Additives , and of removing any ambiguity regarding whether older  B. subtilis  listings also 
encompass microorganisms that would currently be identified as B. amyloliquefaciens , Health 
Canada has been asked to add B. amyloliquefaciens  as a permitted source organism for those 
enzymes (namely amylase, glucanase, hemicellul ase, pentosanase and protease) that can also be 
sourced from B. subtilis .  
 
The results of Health Canada’s evaluation of available microbiological data support the safety of 
B. amyloliquefaciens  as source organism for amylase, glucanase, hemicellulase, pen tosanase and 
protease (indeed, B. amyloliquefaciens  is already listed as an approved source organism for 
amylase for use in infant cereal products). Therefore, Health Canada has modified the List of 
Permitted Food Enzymes  to include B. amyloliquefaciens  as a permitted source for these 
enzymes as follows:    
Notice of Modification to the List of Permitted Food Enzymes  to Enable the U se of Bacillus amyloliquefaciens  as a S ource  
Organism for Food Enzymes that are Currently Permitted to be S ourced from Bacillus subtilis   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3  
Modification to the List of Permitted Food Enzymes   
 
The text in bold  is to be added or modified in column 2 of items A.1, G.1, G.2, G.4, H.1, P.4 and P.6 in the List of 
Permitted Food Enzymes  as follows:  
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 Amylase  Aspergillus niger  var.; 
Aspergillus 
oryzae  var.; Bacillus 
amyloliquefaciens  
var.;  Bacillus 
subtilis  var.; Rhizopus 
oryzae  var.; Barley 
Malt  (1) 
Ale; Beer; Light beer; 
Malt liquor; Porter; 
Stout  (1) 
Good Manufacturing 
Practice  
(2) 
Bread; Flour; Whole 
wheat flour  (2) 
Good Manufacturing 
Practice  
(3) 
Cider; Wine  (3) 
Good Manufacturing 
Practice  
(4) 
Chocolate syrups  (4) 
Good Manufacturing 
Practice  
(5) 
Distillers' Mash  (5) 
Good Manufacturing 
Practice  
(6) 
Malt -flavoured dried 
breakfast cereals  (6) 
Good Manufacturing 
Practice  
(7) 
Single -strength fruit 
juices  (7) 
Good Manufacturing 
Practice  
(8) 
Pre-cooked (instant) 
breakfast cereals  (8) 
Good Manufacturing 
Practice  
(9) 
Starch used in the 
production of dextrins, 
maltose, dextrose, 
glucose (glucose syrup) 
or glucose solids (dried 
glucose syrup)  (9) 
Good Manufacturing 
Practice  
(10) 
Unstandardized bakery 
products  (10) 
Good Manufacturing 
Practice  
(11) 
Plant -based beverages  (11) 
Good Manufacturing 
Practice  
(12) 
Infant cereal products  (12) 
Good Manufacturing  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the U se of Bacillus amyloliquefaciens  as a S ource  
Organism for Food Enzymes that are Currently Permitted to be S ourced from Bacillus subtilis   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 Practice  
Bacillus 
amyloliquefaciens 
EBA 20 (pUBH2);  
Bacillus licheniformis ; 
Bacillus licheniformis 
BML 592 
(pAmyAmp);  Bacillus 
licheniformis BML 
730 (pAmyAmp);  
Bacillus licheniformis 
LA 57 (pDN1981); 
Bacillus licheniformis 
LAT8 (pLAT3);  
Bacillus licheniformis 
LiH 1159 (pLiH1108);  
Bacillus licheniformis 
LiH 1464 (pLiH1346);  
Bacillus licheniformis 
MOL2083 (pCA164 -
LE399) ; Bacillus 
licheniformis PL 1303 
(pPL1117)  (1) 
 Distillers' Mash  (1) 
 Good Manufacturing 
Practice  
(2) 
 Starch used in the 
production of dextrins, 
maltose, dextrose, 
glucose (glucose syrup) 
or glucose solids (dried 
glucose syrup)  (2) 
 Good Manufacturing 
Practice  
(3) 
 Brewers' mash  (3) 
 Good Manufacturing 
Practice  
G.1 Glucoamylase 
(Amyloglucosidase; 
Maltase)  Rhizopus delemar 
var. multiplicisporus  (1) 
 Brewers' Mash  (1) 
Good Manufacturing 
Practice  
(2) 
 Distillers' Mash  (2) 
Good Manufacturing 
Practice  
(3) 
 Mash destined for 
vinegar manufacture  (3) 
Good Manufacturing 
Practice  
(4) 
 Starch used in the 
production of dextrins, 
maltose, dextrose, 
glucose (glucose 
syrup), or glucose 
solids (dried glucose 
syrup)  (4) 
Good Manufacturing 
Practice  
G.2 Glucanase  Aspergillus niger  var.; 
Bacillus 
amyloliquefaciens  
var.;  Bacillus 
subtilis  var.  (1) 
Ale; Beer; Light beer; 
Malt liquor; Porter; 
Stout  (1) 
Good Manufacturing 
Practice  
(2) 
Corn for degermination  (2) 
Good Manufacturing 
Practice  
(3) 
Distillers' Mash  (3) 
Good Manufacturing  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the U se of Bacillus amyloliquefaciens  as a S ource  
Organism for Food Enzymes that are Currently Permitted to be S ourced from Bacillus subtilis   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     5 Practice  
(4) 
Mash destined for 
vinegar manufacture  (4) 
Good Manufacturing 
Practice  
(5) 
Unstandardized bakery 
products  (5) 
Good Manufacturing 
Practice  
G.4 Glucose Isomerase  Actinoplanes 
missouriensis var.; 
Bacillus coagulans 
var.;  Microbacterium 
arborescens NRRL B -
11022 ; Streptomyces 
murinus DSM 3252 ; 
Streptomyces 
olivaceus var.; 
Streptomyces 
olivochromogenes 
var.; Streptomyces 
rubiginosus ATCC 
No. 21,175 ; 
Streptomyces 
rubiginosus SYC 5406 
(pSYC5239)  (1) 
 Glucose (glucose 
syrup) to be partially or 
completely isomerized 
to fructose  (1) 
 Good Manufacturing 
Practice  
H.1 Hemicellulase  Bacillus 
amyloliquefaciens  
var.;  Bacillus 
subtilis  var. 1) 
Distillers' Mash  (1) 
Good Manufacturing 
Practice  
(2) 
Liquid coffee 
concentrate  (2) 
Good Manufacturing 
Practice  
(3) 
Mash destined for 
vinegar manufacture  (3) 
Good Manufacturing 
Practice  
P.4 Pentosanase  Aspergillus niger  var.; 
Bacillus 
amyloliquefaciens  
var.;  Bacillus 
subtilis  var. (1) 
Ale; Beer; Light beer; 
Malt liquor; Porter; 
Stout  (1) 
Good Manufacturing 
Practice  
(2) 
Corn for degermination  (2) 
Good Manufacturing 
Practice  
(3) 
Distillers' Mash  (3) 
Good Manufacturing 
Practice  
(4) 
Mash destined for 
vinegar manufacture  (4) 
Good Manufacturing 
Practice  
(5) 
Unstandardized bakery 
products  (5) 
Good Manufacturing 
Practice   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the U se of Bacillus amyloliquefaciens  as a S ource  
Organism for Food Enzymes that are Currently Permitted to be S ourced from Bacillus subtilis   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     6 (6) 
Bread; Flour; Whole 
wheat flour  (6) 
Good Manufacturing 
Practice  
P.6 Protease  Aspergillus 
niger  var.; 
Aspergillus 
oryzae  var.; Bacillus 
amyloliquefaciens  
var.;  Bacill us 
subtilis  var. (1) 
Ale; Beer; Light beer; 
Malt liquor; Porter; 
Stout  (1) 
Good Manufacturing 
Practice  
(2) 
Bread; Flour; Whole 
wheat flour  (2) 
Good Manufacturing 
Practice  
(3) 
Dairy -based flavouring 
preparations  (3) 
Good Manufacturing 
Practice  
(4) 
Distillers' Mash  (4) 
Good Manufacturing 
Practice  
(5) 
Sausage casings  (5) 
Good Manufacturing 
Practice  
(6) 
Hydrolyzed animal, 
milk and vegetable 
protein  (6) 
Good Manufacturing 
Practice  
(7) 
Industrial spray -dried 
cheese powder  (7) 
Good Manufacturing 
Practice  
(8) 
Cuts of prepared meat; 
Cuts of prepared 
poultry meat  (8) 
Good Manufacturing 
Practice  
(9) 
Meat tenderizing 
preparations  (9) 
Good Manufacturing 
Practice  
(10) 
Pre-cooked (instant) 
breakfast cereals  (10) 
Good Manufacturing 
Practice  
(11) 
Unstandardized bakery 
products  (11) 
Good Manufacturing 
Practice  
(12) 
Colby cheese  (12) 
Good Manufacturing 
Practice  
(13) 
Plant -based beverages  (13) 
Good Manufacturing 
Practice  
 
In addition the following row, which is redundant as a result of the changes noted above, will need to be removed 
from the List of Permitte d Food Enzymes:   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the U se of Bacillus amyloliquefaciens  as a S ource  
Organism for Food Enzymes that are Currently Permitted to be S ourced from Bacillus subtilis   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     7 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 Amylase  Bacillus 
amyloliquefaciens   (1)  
Infant cereal products  (1) 
Good Manufacturing 
Practice  
 
 
* The Permitted sources appearing in column 2 have been re -organized in a few instances 
so that they appear in alphabetical order.  
 
As noted, there is already a separate listing in A.1 for amylase sourced from 
B. amyloliquefaciens  to be used in infant cereal products.  This listing would be made redundant 
by the modifications shown above and can consequently be deleted.  
 
Rationale  
 
Health Canada’s Food Directorate has evaluated the taxonomic change within the genus Bacillus  
that no w discerns B. amyloliquefaciens  as a species that is distinct from B. subtilis . B. 
amyloliquefaciens  is a well -known, non -pathogenic organism that is closely related to B. subtilis .  
B. amyloliquefaciens  was previously evaluated and accepted as a permitted  source of amylase for 
use in infant cereal products. Based on a microbiological evaluation, it is considered acceptable 
to include B. amyloliquefaciens  as a permitted source organism for those enzymes that may also 
be sourced from the closely related B. subtilis .  
 
Other Relevant Information  
 
Health Canada’s decision to recognize Bacillus amyloliquefaciens  as a permitted food enzyme 
source that is distinct from the closely related Bacillus subtilis  aligns with the separate 
classification of these two microorganisms when used as sources for enzymes used in food 
processing in Australia and New Zealand1. In the U.S., carbohydrase (consisting of alpha -
amylase and beta-glucanase) and protease are permitt ed to be sourced from both B. subtilis  and 
B. amyloliquefaciens .2 The Inventory of Substances Used as Processing Aids  (IPA), which is a 
reference tool maintained by the Codex Committee on Food Additives (CCFA), lists both 
B. subtilis  and B. amyloliquefacie ns as sources of various enzymes, and notes in particular that 
B. subtilis  formerly also covered the strains that are now known under the name 
B. amyloliquefaciens.3 
                                              
1 Australia New Zealand Food Standards Code – Standard 1.3.3 – Processing Aids  
2 U.S. FDA Code of Federal Regulations Title 21 Part 184 (Direct Food Substances Affirmed as Generally Recognized 
as Safe), Sections 184.1148 and 184.1150  
3 Inventory of Substa nces Used as Processing Aids (IPA), Updated List  (Information Document FA/45 INFO3, 
February 2013), Published by the Codex Alimentarius Commission for the Codex Committee on Food Additives’s 
45th Session.  
  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the U se of Bacillus amyloliquefaciens  as a S ource  
Organism for Food Enzymes that are Currently Permitted to be S ourced from Bacillus subtilis   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     8  
Food enzymes, including amylase, glucanase, hemicellulase, pentosanase, and protease sour ced 
from B. amyloliquefaciens , used in foods sold in Canada  must meet the food -grade 
specifications set out in the most recent edition of the Food Chemicals Codex (FCC), a 
compendium of standards for purity and identity of food ingredients, including food  additives, 
which is published by the United States Pharmacopeial Convention.  
 
Implementation and Enforcement  
 
The above modification came into force July 15, 2015 , 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 any new scientific information on 
the safety in use of any permitted food additive , including amylase, glucanase, hemicellulase, 
pentosanase and protease sourced from B. amyloliquefaciens . Anyone wishing to submit new 
scientific information on the use of this additive or to submit any inquiries may do so in writing, 
by regular mail or electronicall y. If you wish to contact the Food Directorate elec tronically, 
please use the word  “Enzymes – Bacillus amyloliquefaciens " 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 0L2  
E-mail:  bcs-bipc@hc -sc.gc.ca