G/SPS/N/CAN/1477  
 
20 February 2023  
(23-1191) 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):  Use of Lactase from Bacillus subtilis  DH617 in Lactose -reducing 
Enzyme Preparations and Certain Dairy Foods (ICS code: 67.220.20)  
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 Lactase from Bacillus subtilis  DH617 in Lact ose-reducing 
Enzyme Preparations and Certain Dairy Foods . Language(s):  English and French . 
Number of pages:  4 
https://members.wto.org/crnattachments/2023/SPS/CAN/23_1215_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/CAN/23_1215_00_f.pdf  
6. Description of content:  Health Canada's Food Directorate completed a premarket safety 
assessment of a food additive submission seeking approval for the use of lactase from 
Bacillus subtilis  DH617 in certain dairy foods.  
Lactase from other sources is already permitted for use in Canada in lactose -reducing 
enzyme preparations and certain dairy products. Prior to this notice, B. subtilis  DH617 was 
not a permitted source for any food enzyme in Canada.  
The results of the premarket assessment support the safety of lactase from B. subtilis  
DH617 for its requested uses. Consequently, Health Canada has  enabled the use of lactase 
from this source as described in the information document below by modifying the List of 
Permitted Food Enzymes , effective 6 February 2023.  
The purpose of this communication 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 prot ection, 
[ ] 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) :  G/SPS/N/CAN/1477  
 
- 2 - 
 
  [ ] 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 stand ard:  
9. Other relevant documents and language(s) in which these are available:  
Health  Canada's Food and Nutrition – 'Public Involvement and Partnerships' Website, 
posted 6 February 2023 (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) : 6 February  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) : 6 February 2023  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 21 April 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 
Lactase from Bacillus subtilis  DH617 in Lactose -reducing Enzyme Preparations and Certain 
Dairy Foods" is available through the following weblink:  
https://www.can ada.ca/en/health -canada/services/food -nutrition/public -involvement -
partnerships/notice -modification -list-permitted -food-enzymes -enable -use-lactase -bacillus -
subtilis -dh617 -lactose -reducing -enzyme -preparations -certain -dairy-foods.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/avis -modification -liste-enzymes -alimentaires -autorisees -permettre -utilisation -
lactase -bacillus -subtilis -dh617 -preparations -enzymatiques -reduction -lactose -certains -
produits -laitiers.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