Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protease Obtained from Fusarium venenatum   
WTY939 -8-3 in the Manufacture of Hydrolyzed Animal, Milk and Vegetable Protein   
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 Protease Obtained from 
Fusarium venenatum  WTY939 -8-3 in the Manufacture of 
Hydrolyzed Animal, Milk and Vegetable Protein  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0070] 
 
March  30, 2016   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protease Obtained from Fusarium venenatum   
WTY939 -8-3 in the Manufacture of Hydrolyzed Animal, Milk and Vegetable Protein   
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 and publis hed on Health Canada’s website.  A petitioner 
can request that Health Canada approve a ne w 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 protease 
obtained from  Fusarium venenatum  WTY939 -8-3 in the manufacture of hydrolyzed a nimal, milk 
and vegetable protein at a maximum level of use consistent with good manufacturing practice. 
This protease is to be used for partial or extensive hydrolysis of animal, milk and vegetable 
proteins that will be used as ingredients in a variety of  foods, including beverages. The enzyme is 
also intended for use in manufacturing protein hydrolysates that are to be used in infant formula 
and foods for special dietary use (e.g., formulated liquid diet).  
    
Protease from other microbial sources is already permitted for use in Canada as a food enzyme in 
a variety of food products, including hydrolyzed animal, milk and vegetable protein. Fusarium 
venenatum  WTY939 -8-3 expresses protease from the fungus Fusarium oxysporum .   
 
The results of Health Canada’s evaluation of available scientific data support the safety of 
protease obtained from  Fusarium venenatum  WTY939 -8-3 when used under the conditions of 
use set out in the table below.  Therefore, Health Canada has modified the List of Permitted Food 
Enzymes  to enable the use of protease obtained from  Fusarium venenatum  WTY939 -8-3 by 
adding the entries to the list as indicated 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  
P.6 Protease  Fusarium 
venenatum  
WTY939 -8-3 (1) 
Hydrolyzed animal, 
milk and vegetable 
protein  (1) 
Good Manufacturing Practice  
 
 
Rationale   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protease Obtained from Fusarium venenatum   
WTY939 -8-3 in the Manufacture of Hydrolyzed Animal, Milk and Vegetable Protein   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3  
Health Canada’s Food Directorate completed a pre -market safety assessment of the requested 
uses of  protease obtained from  Fusarium venenatum  WTY939 -8-3.  The assessment considered 
the microbiological, toxicological, nutritional and chemical aspects 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 pr otease obtained from Fusarium venenatum  WTY939 -8-3. 
 
Other Relevant Information  
 
The Food and Drug Regulations require that all food additives, including food enzymes such as 
protease, meet the food -grade specifications set out in the most recent edition o f the Food 
Chemicals Codex (FCC) when there are no specifications set out in the Food and Drug 
Regulations . 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.  
 
In the United States, the Food and Drug Administration (FDA) issued a letter in response to 
GRAS Notice No. GRN 000563 indicating that the Agency had no questions at that time 
regarding the petitioner’s conclusion that the protea se enzyme preparation produced by 
Fusarium venenatum  carrying  a serine protease gene from Fusarium  oxysporum  is Generally 
Recognized as Safe (GRAS) for its intended uses.1  The GRAS notice was for the use of the 
enzyme to make partial and extensively hydro lyzed animal and vegetable protein ingredients.    
 
In Australia and New Zealand, food enzymes are regulated as processing aids under Standard 
1.3.3 of the Australia New Zealand Food Standards Code .  Protease (as ‘‘Trypsin’’) from 
Fusarium venenatum  containing the gene for trypsin isolated from Fusarium oxysporum is 
permitted to be used in the course of manufacturing any food in accordance with the general 
conditions of use of processing aids, including conditions of Good Manufacturing Practice.  
 
Corrective Modifications to the List of Permitted Food Enzymes  
 
A taxonomic update is made by replacing the name of the source “ Trichoderma reesei  ” by the 
name “ Trichoderma longibrachiatum ” in item C.2 in the List of Permitted Food Enzymes . Minor 
editorial modifications are also made to the French version of the List, specifically to sub items  
P.5(5), P.6 for the source Aspergillus melleus , and T.1(1) to consistently list the food as 
“Protéines hydrolysées d'origine animale, végétale ou provenant du lait ”. Previously there was 
inconsistent use of the comma and the term “ou” in the name of the food. Similarly, a spelling 
error in two occurrences of the term “non normalisés” in I tem X.1 in the French version of the 
List was corrected. Finally, item A.2(3) beside the name of the source Bacillus subtilis  BS154 is 
renumbered A.2(2).   
 
Implementation and Enforcement  
 
                                              
1 Agency Response Letter GRAS Notice No. GRN 000563, July 23, 2015.   
Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Protease Obtained from Fusarium venenatum   
WTY939 -8-3 in the Manufacture of Hydrolyzed Animal, Milk and Vegetable Protein   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     4 The above modification came into force March  30, 2016 , 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 food additive, including protease obtained from  Fusarium vene natum  
WTY939 -8-3. Anyone wishing to submit new scientifi c information on the use of this food  
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 word s “Protease from 
Fusarium venenatum ” 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