G/SPS/N/CAN/1419  
 
5 November 2021  
(21-8421) 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):  Maltogenic alpha -Amylase (ICS Codes: 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 Maltogenic alpha -Amylase from Three Sources in Bread, 
Flour, Whole Wheat Flour and Unstandardized Bakery Products . Language(s) : English and 
French . Number of pages:  4 
https://members.wto.org/crnattachments/2021/SPS/CAN/21_7026_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/CAN/21_7026_00_f.pdf  
6. Description of content:  Health Canada's Food Directorate completed a premarket safety 
assessment of each of three food additive submissions seeking approval for the use of 
maltogenic alpha -amylase from Bacillus licheniformis  HyGe750n6, B. subtilis  RF13018, and 
Saccharomyces cerevisiae  M17906 in bread, flour, whole wheat flour, and unstandardi zed 
bakery products.  
Maltogenic alpha -amylase from other sources is already permitted in these foods. The new 
source organisms, B. licheniformis  HyGe750n6, B. subtilis  RF13018, and S. cerevisiae  
M17906, were not permitted sources for any food enzyme in Can ada. 
The results of the premarket assessments support the safety of maltogenic alpha -amylase 
from these three sources for their requested uses. Consequently, Health Canada has 
enabled the use of maltogenic alpha -amylase from B. licheniformis  HyGe750n6, B. subtilis  
RF13018, and S. cerevisiae  M17906 as described in the information document below by 
modifying the List of Permitted Food Enzymes , effective 25 October 2021. Health Canada 
has also updated the entries for the sources B. licheniformis  MDT06 -221, B. subtilis  
BS154, and B. subtilis  RF12029 in the List to reflect the alpha configuration of the 
maltogenic amylase, 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 those wishing to submit 
an inquiry or new scientific information relevant to the safety of this food enzyme from the 
three new sources.  
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/1419  
 
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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 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 lan guage(s) in which these are available:  
Health  Canada's Food and Nutrition - 'Public Involvement and Partnerships' Website, 
posted 25 October 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) : 3 November 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) : 3 November 2021  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 7 January 2022  
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 
Maltogenic alpha -Amylase from Three Sources in 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/pu blic-involvement -
partnerships/notice -modification -list-permitted -food-enzymes -maltogenic -alpha -
amylase.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/avis -modification -liste-enzymes -alimentaires -autorisees -permettre -alpha -
amylase -maltogene.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