G/SPS/N/CAN/998  
 
9 March 2016  
(16-1366)  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): Protease (ICS Code: 67.220) 
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 Protease from Bacillus licheniformis  S10-34zEK4 in the 
Manufacture of Hydrolyzed Animal, Milk and Vegetable Protein - Document Reference Number: NOM/ADM-0068  Language(s): English and French  Number of pages: 3 
and 4 
http://members.wto.org/crnattachments/2016/SPS/CAN/16_0929_00_e.pdf  
http://members.wto.org/crnattachments/2016/SPS/CAN/16_0929_00_f.pdf  
6. Description of content: Health Canada's Food Directorate completed a detailed safety 
assessment of a food additive submission seeking approval for the use of protease from 
Bacillus licheniformis  S10-34zEK4 in the manufacture of hydrolyzed animal, milk and 
vegetable protein. 
Protease from B. licheniformis  (Cx) is already permitted for use in the manufacture of 
hydrolyzed animal, milk and vegetable protein. However, B. licheniformis  S10-34zEK4, 
which is a strain of B. licheniformis  that was developed to be a high yielding protease 
production strain, has not yet been approved as a permitted source of any food enzyme. 
The results of Health Canada's evaluation of available scientific data support the safety 
and efficacy of protease obtained from B. licheniformis  S10-34zEK4 when used as 
requested by the petitioner. Therefore, Health Canada has modified the List of Permitted 
Food Enzymes  (http://www.hc-sc.gc.ca/fn-an/securit/addit/list/9-sweetener-edulcorant-
eng.php ), effective 26 February 2016. 
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 food 
additive. 
Health Canada's Food Directorate is committed to reviewing any new scientific 
information on the safety in use of any food additive, including protease. Anyone wishing 
to submit new scientific information on the us e of this food additive or to submit any 
inquiries may do so in writing, by regular mail or electronically. G/SPS/N/CAN/998 
 
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  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.   
8. Is there a relevant international st andard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g. title or serial  n u m b e r  o f  C o d e x  
standard or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter 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 26 February 2016 (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) : 26 February 2016 
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) : 26 February 2016 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 10 May 2016 
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. Text(s) available from: [ ] National Notifi cation 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 
Protease from Bacillus licheniformis  S10-34zEK4 in the Manufacture of Hydrolyzed 
Animal, Milk and Vegetable Protein - Document Reference Number: NOM/ADM-0068" is 
available through the following weblink:  
http://www.hc-sc.gc.ca/fn-an/cons ult/nom-adm-0068/index-eng.php  (English)  
http://www.hc-sc.gc.ca/fn-an/cons ult/nom-adm-0068/index-fra.php  (French)