Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  
Glucoamylase  from Aspergillus niger  41SAM2 -54 as a Food Enzyme  in Various Foods   
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 Glucoamylase 
from Aspergillus niger 41SAM2 -54 as a Food 
Enzyme  in Various Foods  
 
Notice of Modification  – Lists of Permitted Food Additives  
Reference Number: [NO M/ADM-0116] 
May 25, 2018  
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  
Glucoamylase  from Aspergillus niger  41SAM2 -54 as a Food Enzyme  in Various Foods   
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  (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 f ood 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 received a food additive submission seeking approval for the use of the enzyme 
glucoamylase from Aspergillus niger 41SAM 2-54 in various starch -containing foods  such as ale, 
beer, light beer, malt liquor, porter, stout , bread, flour, whole wheat flour , breakfast cereals , 
infant cereal products , brewer’s mash , distiller’s mash , single -strength fruit juices, single -
strength vegetable juices , and unstandardized bakery products .  The requested maximum level of 
use for each food is consistent with Good Manufacturing Practice (GMP).  
 
Glucoamylase from certain other source organisms, including other strains of the bacterium 
Aspergillus niger , is already permitted for use in Canada as a food enzyme  in the same foods  as 
those lis ted above , with the exception of single -strength vegetable  juices , at a maximum level 
that is consistent with GMP . 
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
glucoamylase from Aspergillus niger 41SAM 2-54 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 
gluco amylase  from this source  by adding the entry shown below to the list.  
 
Modification to the List of Permitted Food Enzymes  
 
Item 
No. Column 1  
Additive  Column 2  
Permitted in or 
Upon Column 3  
Permitted in or Upon Column 4  
Maximum Level of Use 
and Other Conditions  
G.1 Glucoamylase  Aspergillus niger  
41SAM2 -54 (1)  
Ale; Beer; Light Beer; 
Malt liquor; Porter; 
Stout  (1) 
Good Manufacturing 
Practice  
(2)  
Bread; Flour; Whole 
wheat  flour (2) 
Good Manufacturing 
Practice  
(3)  
Breakfast cereals  (3) 
Good Manufacturing  
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  
Glucoamylase  from Aspergillus niger  41SAM2 -54 as a Food Enzyme  in Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    3 Item 
No. Column 1  
Additive  Column 2  
Permitted in or 
Upon Column 3  
Permitted in or Upon Column 4  
Maximum Level of Use 
and Other Conditions  
Practice  
(4)  
Brewers’ mash  (4) 
Good Manufacturing 
Practice  
(5)  
Distillers’ mash  (5) 
Good Manufacturing 
Practice  
(6)  
Infant cereal products  (6) 
Good Manufacturing 
Practice  
(7)  
Single -strength fruit 
juices; Single -strength 
vegetable juices  (7) 
Good Manufacturing 
Practice  
(8)  
Unstandardized bakery 
products  (8) 
Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s F ood Directorate completed a pre market safety assessment of the requested 
uses of glucoamylase from Aspergillus niger 41SAM 2-54.  The assessment did not identify any 
chemical , microbiological,  molecular biological,  nutritional or  toxicological food safety concerns 
with respect to the requested use s of this enzyme .  Therefore, Health Canada  has enabled the 
requested use s of this enzyme from this source  by modifying the List of Permitted Food Enzymes  
as shown  in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations  require that food additives such as gluco amylase from 
Aspergillus niger 41SAM 2-54 that do not have food -grade specifications set out in Part B of the 
Regulations meet the most recent food -grade specifications set out in 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 Food 
Additive Specifications  and its associated General Specifications and C onsiderations for Enzyme 
Preparations  are both  prepared by the Joint FAO/WHO Expert Committee on Food Additives 
(JECFA) and published by the Food and Agriculture Organization of the United Nations.  
  
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of  
Glucoamylase  from Aspergillus niger  41SAM2 -54 as a Food Enzyme  in Various Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch    4 Implementation and Enforcement  
 
The above modification ca me into force May 25, 2018 , 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 any new scientific information on 
the safety in use of any food additive, including glucoamylase from Aspergillus niger 
41SAM 2-54. Anyone wishing to submit new scienti fic information on the use of this additive  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 “glucoamylase (NOM -0116 )” 
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: hc.bcs -bipc.sc@canada.ca