G/SPS/N/CAN/1176  
 
14 June 2018  
(18-3707) 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): Lactase from Bacillus subtilis  CB108 (ICS Codes: 67.220.20)  
4. Regions or countries l ikely 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  CB108 in Lactose -Reducing 
Enzyme Preparations and Certain Dairy Foods - Reference Number: NOM/ADM -0118. 
Language(s): English and French.  Number of pages: 4 and 4  
https://members.wto.org/crnattachments/2018/SPS/CAN/18_3057_00_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/CAN/18_3057_01_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 lactase from 
Bacillus subtilis  CB108 in the manufacture of lactose -reducing enzyme preparation s and 
certain standardized and unstandardized dairy foods.  
As no safety concerns were raised through Health Canada's assessment, the Department 
has enabled the use of the food additive lactase from Bacillus  subtilis  CB108 described in 
the information docum ent below by updating the List of Permitted Food Enzymes , effective 
6 June 2018.  
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 fo r 
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/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 A nimal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  G/SPS/N/CAN/1176  
 
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  [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 6 June  2018:  
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)  (available in English and French)  
10. Proposed date of adoption (dd/mm/yy) : 6 June 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) : 6 June 2018  
[ ] Trade facilitating measure  
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 19 August 2018  
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 bod y:  
The "Notice of Modification to the List of Permitted Food Enzymes  to Enable the Use of 
Lactase from Bacillus subtilis CB108 in Lactose -Reducing Enzyme Preparations and Certain 
Dairy Foods - Reference Number: NOM/ADM -0118" is available through the following 
weblink:  
https://www.canada.ca/ en/health -canada/services/food -nutrition/public -involvement -
partnerships/modification -permitted -enzymes -lactase -enabled -enzyme -preparations -
certain -dairy-foods.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/modification -autorises -enzymes -lactase -autorisee -produits -enzymatiques -
laitiers.html  (French)  
 
or requested from:  
 
Canada's SPS & TBT Notification Authority  and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive  
Ottawa, ON, K1A 0G2  
Canada  
Tel: +(343) 203 4273  
Fax: +(613) 943 0346  
E-mail: enquirypoint@international.gc.ca