G/SPS/N/CAN/1011  
 
21 April 2016  
(16-2253)  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): Transglutaminase from Streptoverticillium mobaraense  
S-8112 (ICS Codes: 67.220, 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 Enable the Use of Transglutaminase from Streptoverticillium mobaraense  
S-8112 in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery Products - 
Document Reference Number: NOM/ADM-0071  Language(s): English and French   
Number of pages: 4 
http://members.wto.org/crnattachments/2016/SPS/CAN/16_1594_00_e.pdf  
http://members.wto.org/crnattachments/2016/SPS/CAN/16_1594_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 
transglutaminase from Streptoverticillium mobaraense  S-8112 as a food enzyme in 
bread, flour, whole wheat flour, and unstandardized bakery products. The enzyme is also 
intended for use in manufacturing protein hydrolysates that are to be used in infant 
formula and foods for special dietary use (e.g., formulated liquid diet). 
Transglutaminase from Streptoverticillium mobaraense  S-8112 is already permitted for 
use in Canada as a food enzyme in unstandardized prepared fish products, simulated 
meat products, certain unstandardized dairy products, and certain standardized meat 
and poultry products. 
The results of Health Canada's evaluation of available scientific data support the safety 
and efficacy of transglutaminase from Streptoverticillium mobaraense  S-8112 when used 
as requested by the petitioner. Therefore, Health Canada has modified the List of 
Permitted Food Enzymes  (http://hc-sc.gc.ca/fn-an/securit/addit/list/5-enzymes-
eng.php ), effective 11 April 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. G/SPS/N/CAN/1011 
 
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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 April 11, 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) : 11 April 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) : 11 April 2016 
[ ] Trade facilitating measure   
12. Final date for comments: [ ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 24 June 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 
Transglutaminase from Streptoverticillium mobaraense  S-8112 in Bread, Flour, Whole 
Wheat Flour, and Unstandardized Bakery Products - Document Reference Number: 
NOM/ADM-0071" is available through the following weblink:  
http://www.hc-sc.gc.ca/fn-an/cons ult/nom-adm-0071/index-eng.php  (English)  
http://www.hc-sc.gc.ca/fn-an/cons ult/nom-adm-0071/index-fra.php  (French)