G/SPS/N/CAN/1258  
 
26 August 2019  
(19-5462) 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):  Polysorbate 80 in various infant foods and nutritional supplement 
powders (ICS Codes: 67.220.20, 67.230)  
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 
Additives with Other Accepted Uses to Enable the Use of Polysorbate 80 in Various Infant 
Foods and Nutritional Supplement Powders - Reference Number: NOM/ADM -0138. 
Language(s):  English and French . Number of pages:  4 
https://members.wto.org/crnattachments/2019/SPS/CAN/19_4609_00_e.pdf  
https://members.wto.org/crnattachments/2019/SPS/CAN/19_4609_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 o f polysorbate 80 in 
the manufacture of spray -dried bacterial culture preparations for use in infant formula 
powders, dried infant cereal products and nutritional supplement powders.  
Polysorbate 80 is already permitted for use in Canada as an emulsifying, g elling, stabilizing 
or thickening agent in a variety of foods.  
The results of the premarket assessment support the safety of polysorbate 80 for its 
requested uses. Consequently, Health Canada has enabled the use of polysorbate 80 
described in the informati on document below by modifying the List of Permitted Food 
Additives with Other Accepted Uses, effective 13 August 2019.  
The purpose of this communication is to publically announce the Department's decision in 
this regard and to provide the appropriate cont act information 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 ani mal/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/1258  
 
- 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 inte rnational 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 13 August 2019 (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) : 13 August 2019  
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) : 13 August 2019  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 26 October 2019  
Agency or authority designated to handle comment s: [ ] 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 Additives with Other Accepted 
Uses to Enable the Use of Polysorbate 80 in Various Infant Foods and Nutritional 
Supplement Powders - Reference  Number: NOM/ADM -0138" is available through the 
following weblink:  
https://www.canada.ca/en/health -canada/services/ food-nutrition/public -involvement -
partnerships/modification -additives -polysorbate -80-infant -foods -nutritional -supplement -
powders.html  (English)  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/modification -additifs -polysorbate -80-aliments -bebe-supplements -nutritifs -
poudre.html  (French)  
Canada's Notification Authority and Enquiry Point  
Technical Barriers and Regulations Division  
Global Affairs Canada  
111 Sussex Drive  
Ottawa, ON K1A 0G2  
Canada  
Tel: +(343) 203 4273  
Fax: +(613) 943 0346  
E-mail: enquiryp oint@international.gc.ca