Notice of Modification to the List of 
Permitted Food Enzymes  to Enable the 
Use of Protease  from Trichoderma 
reesei  RF8963  in Hydrolyzed Animal, 
Milk and Vegetable Protein  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0150 
August  27, 2020 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of  Protease from Trichoderma reesei  RF8963 in 
Hydrolyzed Animal, Milk and Vegetable Protein   – Reference Number: [NO M/ADM -0150]| 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 Pe rmitted 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 foo d 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’s Food Directorate received a food additive submission seeking approval for th e use of 
protease (i.e., serine protease) from Trichoderma reesei  RF8963  in hydrolyzed animal, milk and vegetable 
protein. The food enzyme is intended to be used at a  level consistent with Good Manufacturing Practice.  
Proteases from sources other than T. reesei  are already permitted for use in Canada in various foods, 
including hydrolyzed animal, milk and vegetable protein.  
The results of the Food Directorate’s evalua tion of available scientific data support the safety of  protease 
from T. reesei  RF8963  when used as set out in the table below .  Therefore,  Health Canada has modified the 
List of Permitted Food Enzymes  to extend the use of protease from T. reesei  RF8963 by adding the entry 
shown  in the table  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  Trichoderma reesei  
RF8963  Hydrolyzed animal, milk 
and vegetable protein  Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorat e completed a premarket safety assessment of protease from T. reesei  
RF8963  in hydrolyzed animal, milk and vegetable protein .  The assessment concluded that information 
related to chemistry, microbiology, molecular  biology, nutrition, toxicology and allergenicity  supports the 
safety of protease from T. reesei  RF8963  for its requested use.  Therefore, the Department has enabled the 
requested use of protease from T. reesei  RF8963 by adding to the  List of Permitted Food Enzymes  the new 
entr y shown in the  above table.   
Other Relevant Information  
The Food and Drug Regulations  require that food additives such as protease  that do not have food -grade 
specifications set out in Part B of the Regulations meet the food -grade specifications set out in the  most 
recent edition of 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 Uni ted States Pharmacopeial Convention. The Combined Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of  Protease from Trichoderma reesei  RF8963 in 
Hydrolyzed Animal, Milk and Vegetable Protein   – Reference Number: [NO M/ADM -0150]| 3 
 Compendium of Food Additive Specifications  and its associated General Specifications and Considerations for 
Enzyme Preparations  are prepared by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) a nd 
published by the Food and Agriculture Orga nization of the United Nations.  
Implementation and Enforcement  
The above modification came into force August  27, 2020, 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 protease from T. reesei  RF8963 .  Anyo ne 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 electro nically, please use the words " protease 
(NOM -0150)" in the subject line of your e -mail.  
Bureau of Chemical Safety, Food Dire ctorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0K9  
E-mail: hc.bcs -bipc.sc@canada.ca