Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Glucoamylase Obtained from Aspergillus niger   
126-PE001 -32 as a Food Enzyme in Bread, Flour, Whole Wheat Flour, Unstandardized Bakery Products, Breakfast Cereals,  
and Infant Cereal Products   
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 Obtained from 
Aspergillus niger  126-PE001 -32 as a Food Enzyme in 
Bread, Flour, Whole Wheat Flour, Unstandardized Bakery 
Products, Breakfast Cereals, and Infant Cereal Products  
Notice of Modification –  Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0056] 
 
 
 August 13, 2015   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Glucoamylase Obtained from Aspergillus niger   
126-PE001 -32 as a Food Enzyme in Bread, Flour, Whole Wheat Flour, Unstandardized Bakery Products, Breakfast Cereals,  
and Infant Cereal Products   
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 He alth 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 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 obtained from Aspergillus niger  126- PE001- 32 at a maximum level of use 
consistent with Good Manufacturing Practice (GMP) in bread, flour, whole wheat flour, unstandardized bakery products, breakfast cereals, and infant cereal products.  Glucoamylase from various sources is already permitted for use in Canada as a food enzyme in bread, flour, whole wheat flour, unstandardized bakery products, pre -cooked (instant) breakfast 
cereal (a sub -group of breakfast cereals) and infant cereal products. However, Aspergillus niger  
126-PE001- 32 is not an approved source organism for any enzyme on the 
List of Permitted Food 
Enzymes . 
 The results of Health Canada’s evaluation of available scientific data support the safety of glucoamylase obtained from Aspergillus niger  126- PE001- 32 when used as requested by the 
petitioner.  Therefore,  Health Canada has modified the List of Permitted Food Enzymes
 by adding 
Aspergillus niger  126- PE001- 32 to the list of permitted sources of glucoamylase as shown 
below .  
 
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  
G.1 Glucoamylase 
(Amyloglucosidase; Maltase)  Aspergillus 
niger  126-
PE001- 32 (1)  
Bread; Flour; Whole wheat flour  (1)  
Good Manufacturing 
Practice  
(2) 
Unstandardized bakery products  (2)  
Good Manufacturing 
Practice   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Glucoamylase Obtained from Aspergillus niger   
126-PE001 -32 as a Food Enzyme in Bread, Flour, Whole Wheat Flour, Unstandardized Bakery Products, Breakfast Cereals,  
and Infant Cereal Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 (3)  
Breakfast cereals  (3) 
Good 
Manufacturing 
Practice  
(4)  
Infant cereal products  (4)  
Good Manufacturing 
Practice  
 
Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of the requested 
uses of glucoamylase obtained from Aspergillus niger  126- PE001- 32.  The assessment 
considered microbiological, toxicological, chemical and technical aspects of these uses of this 
additive, and found that the requested uses are acceptable from a food safety perspective. Therefore, the Department has enabled the requested uses of glucoamylase obtained from A. niger  126- PE001- 32 by modifying the List of Permitted Food Enzymes  as described in the 
above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations require that food additives such as glucoamylase obtained from 
A. niger  126- PE001- 32, which do not have specifications set out in the Regulations, meet the 
food- grade specifications set out in the most recent edition of the Food Chemicals Codex (FCC). 
The FCC is a compendium of standards for  purity and identity for food ingredients, including 
food additives, which is published by the United States Pharmacopeial Convention. 
Implementation and Enforcement  
 
The above modification came into force August 13, 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 re spect 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 glucoamylase obtained from A. niger  
126-PE001- 32. 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 electronically.  If you wish to 
contact the Food Directorate electronically, please use the words  “glucoamylase obtained from 
A. niger  126- PE001- 32" in the subject line of your e -mail.  
  
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Glucoamylase Obtained from Aspergillus niger   
126-PE001 -32 as a Food Enzyme in Bread, Flour, Whole Wheat Flour, Unstandardized Bakery Products, Breakfast Cereals,  
and Infant Cereal Products   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 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