G/SPS/N/CAN/1432  
 
7 April 2022  
(22-2818) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English/French  
 
  NOTIFICATION  
1. Notifying Member:  CANADA  
If applicable, name of local government involved:   
2. Agency responsible:  Health Canada  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Thermolysin from Anoxybacillus caldiproteolyticus  TP7 (ICS Codes: 
67.220.20; 67.060)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  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 F lour and Unstandardized Bakery Products . Language(s):  
English and French . Number of pages:  4 
https://members.wto.org/crnattachments/2022/SPS/CAN/22_2603_00_f.pdf  
https://members.wto.org/crnattachments/2022/SPS/CAN/22_2603_00_e.pdf  
6. Description of content:  Health Canada's Food Directorate completed a premarket safety 
assessment of a food additive submission seeking approval for the use of the thermolysin 
(a type of protease) from Anoxybacillus caldiproteolyticus  TP7 in bread, flour, whole wheat 
flour and unstandardized bakery products.  
Thermolysin from A. caldiproteolyti cus TP7 was alreadypermitted 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 
already permitted for use in the same f oods as those requested by the petitioner.  
The results of the premarket assessment support the safety of thermolysin from 
A. caldiproteolyticu s TP7 for its requested uses. Consequently, Health Canada has enabled 
the uses of thermolysin from A. caldiproteol yticus  TP7 and changed the name of the source 
Geobacillus stearothermophilus  TP7 to A. caldiproteolyticus  TP7 to match the current 
taxonomic classification as described in the information document by modifying the List of 
Permitted Food Enzymes , effective 24 March 2022.  
The purpose of this communication is to publically announce the Department's decision in 
this regard and to provide the appropriate contact information for those wishing to submit 
an inquiry or new scientific information relevant to the safe ty of this food additive.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   G/SPS/N/CAN/1432  
 
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  8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapte r number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:  
Health  Canada's Food and Nutrition – 'Public Involvement and Partnerships' Website, 
posted 24 March 2022 (available in English and French):  
https://www.canada.ca/en/health -canada/services/food -nutrition/public -involvement -
partnerships.html  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats.html  
10. Proposed date of adoption (dd/mm/yy) : 24 March 2022  
Proposed date of publication (dd/mm/yy) :  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 24 March 2022  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 6 June 2022  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
availa ble) of other body:   
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
The "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" is available through the following weblink:  
https://www.canada.ca/en/health -canada/services/food -nutrition/public -involvement -
partnerships/notice -modification -list-permitted -food-enzymes -thermolysin -anoxybacillus -
caldiproteolyticus -tp7.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/avis -modification -liste-enzymes -alimentaires -autorisees -thermolysine -
anoxybacil lus-caldiproteolyticus -tp7.html  (French)  
 
Canada's Notification Authority and Enquiry Point  
Technical Barriers and Regulations Division  
Global Affairs Canada  
111 Sussex Drive  
Ottawa, Ontario, K1A 0G2  
Canada  
Tel: +(343) 203 4273  
Fax: +(613) 943 0346  
E-mail: enquirypoint@international.gc.ca