Notice of Modification to the List of 
Permitted Food Enzymes to Enable 
the Use of Subtilisin from Bacillus 
licheniformis  PP6107 in Various Foods  
 
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0195 
February  22, 2023 
 Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Subtilisin from Bacillus licheniformis  PP6107 in 
Various Foods  2 
 Summary  
Food additives are regulated in Canada under Marketing Authorizations  (MAs) issued by th e 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 Permitted Food Additives  that are incorporated by reference in 
the MAs and published on the Canada.ca website. A petitioner can request that Health Canada a uthorize  a 
new additive , or a new s ource  or a new condition of use for an already permitted  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 saf ety of food additives when used 
under specified conditions in foods sold in Canada.  
Health Canada’s Food Directorate received a food additive submission seeking authorization  for the use of 
subtilisin from Bacillus licheniformis  PP6107 in the manufacture of hydrolyzed animal, milk and vegetable 
protein, hydrolyzed yeast, and plant -based foods . This food enzyme  is a type of protease. It is used to 
catalyze the hydrolysis of proteins,  either to manufacture protein hydrolysates or hydroly zed yeast that can, 
in turn, be used as ingredients in other foods, or to hydrolyze proteins during processing of plant -based foods 
to create more soluble constituents, reduce bitterness, and improve flavour. The requested maximum level 
of use is Good Manu facturing Practice . 
Protease from other sources is already permitted for use in the foods requested by the petitioner, with the 
exception of plant -based foods that are not beverages. While other strains of B. licheniformis  are permitted 
sources for food en zymes, including protease , B. licheniformis PP6107 was not a permitted source for any 
food enzyme in Canada.  
The results of the Food Directorate’s evaluation of available scientific data s upport the safety o f subtilisin 
from B. licheniformis  PP6107 when used as requested by the petitioner. Therefore, Health Canada has 
modified the List of Permi tted Fo od Enzyme s to enable  the use of subtilisin  from this source by adding the 
entries shown below to the list . For the definition of “Good Manufacturing Practice” set out in Column 4 as a 
Maximum Level of Use, see the Marketing Authorization for Food Additives That May Be Used as Food 
Enzymes . 
 
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 (iii) 
Subtilisin  Bacillus licheniformis  
PP6107  (1) 
Hydrolyzed animal, milk 
and vegetable protein  (1) 
Good Manufacturing 
Practice  
(2) 
Hydrolyzed yeast  (2) 
Good Manufacturing 
Practice  
(3) 
Plant -based products that 
resemble dairy products; 
Plant -based products tha t 
resemble dairy -based 
products  (3) 
Good Manufacturing 
Practice  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Subtilisin from Bacillus licheniformis  PP6107 in 
Various Foods  3 
 Item 
No. Column 1  
Additive  Column 2  
Permitted Source  Column 3  
Permitted in or Upon  Column 4  
Maximum Level of Use 
and Other Conditions  
(4) 
Plant -based products that 
resemble egg products  (4) 
Good Manufacturing 
Practice  
(5) 
Plant -based products that 
resemble meat products 
including simulated meat 
products; Plant -based 
products that resemble 
poultry  meat  products 
including simulated 
poultry products  (5) 
Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of subtilisin from 
B. licheniformis  PP6107  for use as a food enzyme  in the manufacture of hydrolyzed animal, milk and 
vegetable protein, hydrolyzed yeast, and plant -based foods . The Directorate considered  allergenicity, 
chemistry, microbiology, molecular b iology, nutrition, and toxicology  in the assessment. The results of the 
assessment support the safety of subtilisin from B. licheniformis  PP6107  for its requested uses.  Therefore, 
Health Canada  has enabled the requested use of  subtilisin from B. licheniformis  PP6107  by adding to the List 
of Permitted Food Enzymes  the entr ies shown in the above table.  
Other Relevant Information  
Food additives such as subtilisin  are required to meet food -grade specifications set out in Part B of the 
Regulations , where such specifications exist,  or those set out in the  most recent  edition of the  Food 
Chemicals Codex  or the Combined Compendium of Food Additive Specificati ons where there are no 
specifications in Part B . The Food Chemicals Codex  is a compendium of food -grade specifications  for food 
ingredients, including food additives, published by the United States Pharmacopeial Convention. 
Specifications in the  Combined C ompendium 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) , both of which are  published by the Food and Agricul ture Orga nization 
of the United Nations.  
Implementation and Enforcement  
The above modification came into force February 22 , 2023, 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.  Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of Subtilisin from Bacillus licheniformis  PP6107 in 
Various Foods  4 
 Contact Information  
Health Canada's Food Directorate is committed to reviewing new scientific information on the safety in use of 
any permitted  food additive . Anyone wishing to submit an inquiry or new scientific informati on on the use of 
a permitted  food additive may do so in writing, by regular mail or electronically.  If you wish to contact the 
Food Directorate electronically  about su btilisin f rom Bacillus licheniformis  PP6107 , please use the words 
"subtilisin  (NOM -0195)" 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 0K9  
E-mail: bcs-bipc@hc -sc.gc.ca