Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Protease from Geobacillus stearothermophilus  TP7  
as an Enzyme in Hydrolyzed Animal, Milk, and Vegetable Protein, and in Hydrolyzed Yeast   
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 from Geobacillus 
stearothermophilus  TP7 as an Enzyme in Hydrolyzed 
Animal, Milk, and Vegetable Protein, and in Hydrolyzed 
Yeast  
Notice of Modification – Lists of Permitted Food Additives  
Reference Number: [NOM/ADM -0077] 
 
 
 July 14, 2016   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Protease from Geobacillus stearothermophilus  TP7  
as an Enzyme in Hydrolyzed Animal, Milk, and Vegetable Protein, and in Hydrolyzed Yeast   
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 th eir 
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 Health 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 protease from 
Geobacillus stearothermophilus  TP7 as a food enzyme at a maximum level of use in accordance 
with good manufacturing practice (GMP) in hydrolyzed animal, milk, a nd vegetable protein, and 
in hydrolyzed yeast . Protease from various other source organisms is already permitted for use in 
Canada as a food enzyme in a range of foods, including hydrolyzed animal, milk and vegetable 
protein. However, Geobacillus stearoth ermophilus  TP7 has not previously been approved in 
Canada as a permitted source for any enzyme.   
 
The results of Health Canada’s evaluation of available scientific data support the safety and 
efficacy of protease from G. stearothermophilus  TP7 when used a s requested by the petitioner.  
Therefore, Health Canada has modified  the List of Permitted Food Enzymes  to extend the use of 
protease by adding the entry shown below to the list.  
 
Modifications 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  Geobacillus 
stearothermophilus  
TP7 (1) 
Hydrolyzed animal, 
milk and vegetable 
protein  (1) 
Good Manufacturing 
Practice  
(2) 
Hydrolyzed yeast  (2) 
Good Manufacturing 
Practice   
Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Protease from Geobacillus stearothermophilus  TP7  
as an Enzyme in Hydrolyzed Animal, Milk, and Vegetable Protein, and in Hydrolyzed Yeast   
Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch     3  
Justification  
 
Health Canada’s Food Directorate completed a pre -market safety assessment of the requested 
uses of protease from G. stearothermophilus  TP7.  The assessment considered microbiological, 
toxicological, 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 protease from G. stearothermophilus  TP7 by modifying the List of Permitted Food 
Enzymes  as described in the above table.  
 
Implementat ion and Enforcement  
 
The above modification came into force July 14, 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 info rmation on 
the safety in use of any food additive, including protease from Geobacillus stearothermophilus  
TP7. 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 " protease from Geobacillus 
stearothermophilus  TP7" 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