G/SPS/N/CAN/1503  
4 May 2023  
(23-3133) 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):  Alpha -Amylase from Bacillus subtilis  AR-651 in bread, flour, whole 
wheat flour and unstandardized bakery products (ICS codes: 67.220.20; 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 alpha -Amylase from Bacillus  subtilis  AR-651 in bread, flour, 
whole wheat flour and unstandardized bakery products . Language(s):  English and 
French . Number of pages:  3 
https://members.wto.org/crnattachments/2023/SPS/CAN/23_09419_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/CAN/23_09419_00_f.pdf  
6. Description of content:  Health Canada's Food Directorate completed a premarket safety 
assessment of a food additive submission seeking authorization for the use of 
alpha -amylase (α -amylase) from Bacillus subtilis AR-651 in bread, flour, whole wheat 
flour, and unstandardized bakery products. The requested maximum level of use for this 
food e nzyme is Good Manufacturing Practice.  
The results of the premarket assessment support the safety of α -amylase from B. subtilis 
AR-651 for its requested uses. Consequently, Health Canada has enabled the use of 
α-amylase from this source as described in the information document by modifying the 
List of Permitted Food Enzymes , effective 27 April 2023.  
The purpose of this information document is to publicly 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 
additive.  
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 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) :  G/SPS/N/CAN/1503  
 
- 2 - 
 
  [ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international st andard?  
[ ] 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 27 April 2023 (available in English and French):  
https://www.canada.ca/en/health -canada/servic es/food -nutrition/public -involvement -
partnerships.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/part icipation -public -
partenariats.html  (French)  
10. Proposed date of adoption (dd/mm/yy) : 27 April 2023  
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) : 27 April 2023  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 10 July 2023  
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 
alpha -Amylase from Bacillus subtilis  AR-651 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/public -involvement -
partnerships/notice -modification -list-permitted -food-enzymes -enable -alpha -amylase -
bacillus -subtilis -ar-651-bread -flour-whole -wheat -flour-unstandardized -bakery -
products.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/avis -modification -liste-enzymes -alimentaires -autorisees -permettre -utilisation -
alpha -amylase -bacillus-subtilis -ar-651-farine -ble-entier -pain-produits -boulangerie -non-
normalises.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