 
  
Notice of Modification to the  List of 
Permitted Food Enzymes to Extend the Use 
of Thermolysin  from Anoxybacillus 
caldiproteolyticus TP7 to Bread, Flour , 
Whole Wheat Flour and Unstandardized 
Bakery Products  
Notice of Modification  – Lists of Permitted Food 
Additives  
Reference Number: NOM/ADM-0181 
March  24, 2022  
 
 Notice of Modification to the List of Permitted Food  Enzymes to Extend the Use of Thermolysin  from Anox ybacillus caldiproteolyticus  
TP7 to Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products   – Reference Number: NOM/ADM -0181| 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 Per mitted 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 , a new source  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’s Food Directorate received a food additive submission seeking approval for the use  of the 
thermolysin  (a type of protease)  from Anoxybacillus caldiproteolyticus  TP71 in bread, flour, whole wheat 
flour, and unstandardized bakery products . This food enzyme is intended to be used at a level consistent with 
Good Manufacturing Practice .2 
Thermolysin  from A. caldiproteolyticus  TP7 was already permitted  for use in certain hydrolyzed foods,  but it 
previously appeared in the  List of Permitted Food Enzymes  as “Protease from Geobacillus  stearothermophilus  
TP7”. Protease from other sources is alre ady permitted for use in the  same  foods as those requested by the 
petitioner.  
The results of the Food Directorate’s evaluation of available scientific data support the safety of  thermolysin  
from A. caldiproteolyticus  TP7 for its requested use s. Therefore,  Health Canada has modified the List of 
Permitted Food Enzymes  to extend  the use  of this enzyme by adding a new entry for thermolysin , as a new 
subitem P.6(ii), at the end of Item P.6 in the List , as shown in the table below.   
 
Housekeeping Modification  
The new entry for thermolysin also includes the permitted uses of this enzyme in hydrolyzed animal, milk, 
and vegetable protein, and hydrolyzed yeast, that had previously appeared as the entry for “Protease from 
Geobacillus  stearothermophilus  TP7”. This ch ange specifies that this particular protease is “thermolysin”. It 
also corrects the name of the source  to A. caldiproteolyticus  TP7 (to match the current taxonomic 
classification ). 
                                                             
1 The petitioner indicated that there was a taxonomic change in the name of the strain from Geobacillus 
stearothermophilus  TP7 to Anoxybacillus caldiproteolyticus  TP7.  
2 See the definition of Good Manufacturing Practice in the Marketing Authorization for Food Additives That May Be 
Used as Food Enzymes . Notice of Modification to the List of Permitted Food  Enzymes to Extend the Use of Thermolysin  from Anox ybacillus caldiproteolyticus  
TP7 to Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products   – Reference Number: NOM/ADM -0181| 3 
 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 (ii) 
Thermolysin  Anoxybacillus  
caldiproteolyticus TP7 (1)  
Hydrolysed animal, milk 
and vegetable protein  (1)  
Good Manufacturing 
Practice  
(2)  
Hydrolysed yeast  (2)  
Good Manufacturing 
Practice  
(3) 
Bread; Flour, Whole 
wheat flour  (3)  
Good Manufacturing 
Practice  
(4) 
Unstandardized bakery 
products  (4) 
Good Manufacturing 
Practice  
Rationale  
Health Canada’s Food Directorate completed a premarket safety assessment of thermolysin  from A. 
caldiproteolyticus  TP7 for use as a food enzyme in the foods requested by the petitioner . The Department  
conclud ed that information related to allergenicity, chemistry, microbiology, molecular b iology,  nutrition  and 
toxicology supports the safety of thermolysin  from A. caldiproteolyticus  TP7 for its requested uses.  Therefore, 
the Department has e nabled  the requested uses of thermolysin  from A. caldiproteolyticus  TP7 by adding to 
the List of Permitted Food Enzymes  the entries  to new  subitem P.6(ii) , as shown above .  
Other Relevan t Information  
Food additives such as thermolysin  from A. caldiproteolyticus  TP7 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 
Specifications . The Food Chemicals Codex  is a compendium of standards for purity and identity for food 
ingredients, including food additives, published by the United States Pharmacopeial Conventio n. 
Specifications in the  Combined 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) , both of which ar e published by the Food and Agriculture Orga nization 
of the United Nations.  
Implementation and Enforcement  
The above modification came into force March  24, 2022, the day it was published in  the List of Permitted 
Food Enzymes . Notice of Modification to the List of Permitted Food  Enzymes to Extend the Use of Thermolysin  from Anox ybacillus caldiproteolyticus  
TP7 to Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products   – Reference Number: NOM/ADM -0181| 4 
 The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Dr ugs 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 thermolysin  from A. cal diproteolyticus  TP7. Anyone wishing to submit 
an inquiry or new scienti fic information on the use of this additi ve may do so in writing, by regular mail or 
electronically. If you wish to contact the Food Directorate electronically, please use the words " thermolysin  
(NOM -0181)" in the subject line of your e -mail.  
Bureau of Chemical S afety, Food Directorate  
251 Sir Frederick Banting Driveway  
Tunney’s Pasture, PL: 2202C  
Ottawa, Ontario K1A 0K9  
E-mail: bcs-bipc@hc -sc.gc.ca  