G/SPS/N/CAN/689  
 
12 June 2013  
(13-3034)  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; IC S numbers should be provided in 
addition, where applicable): Milk coagulating enzyme obtained from Rhizomucor 
miehei  (ICS Codes: 67.220, 67.100) 
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 Obtained from Rhizomucor 
miehei  in Cheese Analogues- Document Reference number: NOM/ADM-0011  
Language(s): English and French  Number of pages: 3 and 4 
http://members.wto.org/crnattachments/2013/sps/CAN/13_2213_00_e.pdf  
http://members.wto.org/crnattachments/2013/sps/CAN/13_2213_00_f.pdf  
6. Description of content: Health Canada's Food Directorate has completed a detailed 
safety assessment of two food additive subm issions seeking approval for the use of milk 
coagulating enzyme obtained from Rhizomucor miehei  in cheese analogues. 
Health Canada previously approved the use of this food additive in other food 
applications described in the List of Permitted Food Enzymes  ("http://hc-sc.gc.ca/fn-
an/securit/addit/list/5-enzymes-eng.php "). 
As no safety concerns were raised through this assessment, and since this food additive 
is already approved for use in other foods in  Canada, the Department is enabling its use 
as described in the information document. The purpose of this communication 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 any new scientific information relevant to the safety of this additive. 
Health Canada's Food Directorate is committed to reviewing any new scientific 
information on the safety in use of any food additive, including milk coagulating enzyme obtained from R. miehei . 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. 
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/689 
 
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  8. Is there a relevant international st andard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) The Joint FAO/WHO Expert Committee for Food 
Additives (JECFA) in 1974 established an acceptable daily intake (ADI) of "not 
specified" for microbial rennet (i.e., milk coagulating enzyme) from Mucor miehei  
(whose current name is Rhizomucor miehei ). This designation is assigned to 
substances that have a very low toxicity and, on the basis of available data and 
the total dietary intake, do not pose a health hazard. 
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] 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 
6 June 2013 (available in English and French): 
http://www.hc-sc.gc.ca/fn-an/consult/index-eng.php  (English) 
http://www.hc-sc.gc.ca/fn-an/consult/index-fra.php  (French) 
10. Proposed date of adoption (dd/mm/yy) : The proposed food additive use will be 
legally enabled once it is published in Health Canada's List of Permitted Food Enzymes  
(http://hc-sc.gc.ca/fn-an/securit/addit/list/5-enzymes-eng.php ). 
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) : The food additive use noted in this document comes into force 
the day on which the modifications are made to the List of Permitted Food Enzymes  
(http://hc-sc.gc.ca/fn-an/securit/addit/list/5-enzymes-eng.php ). 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 20 August 2013 
Agency or authority designated to hand le comments: [ ] National Notification 
Authority, [X] National Enquiry Point. Address, fax number and e-mail address 
(if available) of other body:   
13. Texts available from: [ ] National Notifi cation Authority, [X] National Enquiry 
Point. Address, fax number and e-mail address (if available) of other body:   
The electronic version of: "Notice of Modification to the List of Permitted Food Enzymes  
to Enable the Use of Milk Coagulating Enzyme Obtained from Rhizomucor miehei  in 
Cheese Analogues-Document Reference number: NOM/ADM-0011" can be ordered at:  
http://www.hc-sc.gc.ca/fn-an/cons ult/nom-adm-0011/index-eng.php  (English) 
http://www.hc-sc.gc.ca/fn-an/cons ult/nom-adm-0011/index-fra.php  (French) 
http://members.wto.org/crnattachments/2013/sps/CAN/13_2213_00_e.pdf  (English) 
http://members.wto.org/crnattachments/2013/sps/CAN/13_2213_00_f.pdf  (French) 
List of Permitted Food Enzymes : 
http://hc-sc.gc.ca/fn-an/securit/addit/list/5-enzymes-eng.php  (English) 
http://hc-sc.gc.ca/fn-an/securit/addit/list/5-enzymes-fra.php  (French)