G/SPS/N/CAN/1216  
 
20 November 2018  
(18-7254) 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 from Bacillus subtilis  RF12029 
(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 Maltogenic alpha -Amylase from Bacillus subtilis  RF12029 
in Bread, Flour, Whole Wheat Flour, and Unstandardized Bakery Products -  
Reference Number: NOM/ADM -0125. Language(s): English and French .  Number of 
pages: 3 and 4  
https://members.wto.org/crnattachments/2018/SPS/CAN/18_5965_00_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/CAN/18_5965_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 maltogenic 
alpha -amylase from Bacillus subtilis  RF12029 in the manufacture of bread, flour, whole 
wheat flour, and unstandardized bakery products.  
Maltogenic alpha -amylase from other source organisms is already specifically permitted 
for use as a food enzyme in Canada in the manufacture of all the foods of interest to the 
petitioner.  
As no safety concerns were identified through Health Canada's assessment, the 
Department has enabled the use of the food additive maltogenic alpha -amylase from B. 
subtilis  RF12029 as described in the information document below by  
modifying the  List of Permitted Food Enzymes  (https://www.canada.ca/en/health -
canada /services/food -nutrition/food -safety/food -additives/lists -permitted/5 -
enzymes.html ), effective  8 Novemb er 2018.  
The purpose of this communication is to publically announce the Department's decision 
in this regard and to provide the appropriate contact info rmation for any inquiries or for 
those wishing to submit any 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/plan t pest or disease, [  ] protect territory from 
other damage from pests.  G/SPS/N/CAN/1216  
 
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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 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 8 November  2018 (available in English and French):  
https://www.canada.ca/en/health -canada/services /food -nutrition/public -involvement -
partnerships.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats.html  (French)   
10. Proposed date of adoption (dd/mm/yy) : 8 November 2018  
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) : 8 November 2018  
[ ] Trade facilitating measure  
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 21 January 2109  
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 Bacillus subtilis RF12029 in Bread, Flour, Whole Wheat 
Flour, and Unstandardized Bakery Products - Reference Number: NOM/A DM-0125" is 
available through the following weblink:  
https://www.canada.ca/en/health -canada/services/food -nutrition/public -involvement -
partnerships/modification -list-permitted -enzymes -maltogenic -alpha -amylase -bacillus -
bread -whole -wheat -unstandardized -bakery -product s.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/modification -permettre -enzymes -maltogene -bacillus -subtilis -pain-ble-
produits -boulangeries -non-normalises.html  (French)  
 
Canada's SPS and TBT Notification Aut hority and Enquiry Point  
Technical Barriers and Regulations Division  
Global Affairs Canada  
111 Sussex Drive  
Ottawa, Ontario  
K1A 0G2  
Tel: +(343) 203 4273  
Fax: +(613) 943 0346  
E-mail: enquirypoint@international.gc.ca