Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Asparaginase Obtained from Aspergillus niger AGN7 -41 
as a Food Enzyme in Bread, Flour, Whole Wheat Flour, and Unstandardized 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 Asparaginase Obtained 
from Aspergillus niger AGN7 -41 as a Food Enzyme in 
Bread, Flour, Whole Wheat Flour, and 
Unstandardized Foods  
 
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0023] 
 
 
 January 21, 2014   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Asparaginase Obtained from Aspergillus niger AGN7 -41 
as a Food Enzyme in Bread, Flour, Whole Wheat Flour, and Unstandardized 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.  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.  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 asparaginase 
obtained from Aspergillus niger  AGN7 -41 as a food enzyme at a maximum level of use in 
accordance with good manufacturing practice in bread, flour, whole wheat fl our, and 
unstandardized foods. The purpose of using asparaginase in these products is to reduce the 
formation of acrylamide.  
 
Asparaginase, when obtained from another strain of Aspergillus niger (A. niger ASP72), is 
already permitted for use in Canada as a  food enzyme in bread, flour, whole wheat flour and 
unstandardized foods.   
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
asparaginase obtained from A. niger AGN7 -41 when used as requested by the petitioner.  
Therefore, Health Canada has modified the List of Permitted Food Enzymes  to extend the use of 
asparaginase by adding the entry shown below to the List.   
 
Modification to th e 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.3 Asparaginase  Aspergillus 
niger AGN7 -
41 (1) Bread; Flour; 
Whole wheat 
flour  
(2) Unstandardized 
foods  
 (1) Good 
Manufacturing Practice  
 
(2) Good 
Manufacturing Practice  
 
 
  
 
 
  
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Asparaginase Obtained from Aspergillus niger AGN7 -41 
as a Food Enzyme in Bread, Flour, Whole Wheat Flour, and Unstandardized Foods   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3 Rationale  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of asparaginase 
obtained from A. niger AGN7 -41.  The assessment considered microbiological, toxicological, 
nutritional and technical aspects of asparaginase obtained from A. niger AGN7 -41 when used as 
requested in the food additive submission.     
 
Based on the results of the safety assessment,  Health Canada’s Food Directorate considers that 
the data support the safety of asparaginase obtained from A. niger AGN7 -41 when used under 
the conditions evaluated.  The Department has therefore enabled the use of asparaginase obtained 
from A. niger AGN7 -41 as described in the above table.  
 
Other Relevant Information  
 
The Food and Drug Regulations require that all food enzymes, including asparaginase, used as 
food additives meet the specifications for enzyme preparations set out in the most recent edition 
of the Food Chemicals Codex (FCC). The FCC is 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 ca me into force January 21 , 2014, 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 asparaginase. 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 " asparaginase " 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