G/SPS/N/CAN/1415  
 
27 September 2021  
(21-7189) 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):  Milk coagulating enzyme from Rhizomucor miehei  CBS 146319 in 
yogurt (ICS Codes: 67.220.20, 67.100.99)  
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 Enable the Use of Milk Coagulating Enzyme from Rhizomucor miehei  
CBS 146319 in Yogurt . Language(s):  English and French . Number of pages:  3 
https://members.wto.org/crnattachments/2021/SPS/CAN/21_6142_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/CAN/21_6142_00_f.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 milk coagulating 
enzyme from Rhizomucor miehei  CBS 146319 in the manufacture of yogurt.  
Milk coagulating enzyme from wild -type R. miehei  (Cooney and Emerson) is already 
permitted for us e in Canada in the manufacture of various standardized cheeses, sour 
cream, dairy -based flavouring preparations, and hydrolyzed animal, milk and vegetable 
protein. Milk coagulating enzyme from other microbial sources is already permitted for 
certain uses. However, milk coagulating enzyme from any source has not been permitted 
in the manufacture of yogurt.  
The results of the premarket assessment support the safety of milk coagulating enzyme 
from R. miehei  CBS 146319 for its requested use in the manufacture o f yogurt. 
Consequently, Health Canada has enabled the use of milk coagulating enzyme from 
R. miehei  CBS 146319 described in the information document by modifying the List of 
Permitted Food Enzymes , effective 17 September 2021.  
The purpose of this communica tion is to publically announce the Department's decision in 
this regard and to provide the appropriate contact information for any inquiries or for 
those wishing to submit new scientific information relevant to the safety of this food 
additive.  
7. Objecti ve 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/1415  
 
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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, chapter number) :  
[ ] International Plant Protecti on 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 17 September 2021 (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) : 17 September 2021  
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) : 17 September 2021  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 30 November 2021  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) 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 Enable the Use of Milk 
Coagulating Enzyme from Rhizomucor miehei  CBS 146319 in Yogurt" is available through 
the following weblink:  
https://www.canada.ca/en/health -canada/services/food -nutrition/public -involvement -
partnerships/n otice-modication -list-permitted -food-enzymes -milk-coagulating -enzyme -
rhizomucor -miehei.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/avis -modification -liste-enzymes -alimentaires -autorisees -permettre -utilisation -
enzyme -coagulant -lait-rhizomucor -miehei.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