G/SPS/N/CAN/1459  
 
13 October 2022  
(22-7703) 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):  Milk thistle seed extract (silymarin) as a supplemental ingredient in 
foods  
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:  Health Canada's proposal to enable the use of milk 
thistle seed extract (silymarin) as a supplemental ingredient in foods . Language(s):  
English and French . Number of pages:  4 and 5  
6. Description of content:  Health Canada's Food Directorate completed a detailed 
premarket safety assessment of milk thistle seed extract for use as a supplemental 
ingredient in foods, under the Supplemented Foods regulatory framework. The results of 
the premarket assessment support  the safety of standardized milk thistle seed extracts 
based on the silymarin content. Consequently, Health Canada intends to enable the use of 
milk thistle seed extract (silymarin) by modifying the List of Permitted Supplemental 
Ingredients  as described i n the Notice of Proposal information document.  
The purpose of this communication is to publicly announce the Department's intention in 
this regard and to provide the appropriate contact information for any inquiries or for 
those wishing to submit new scien tific information relevant to the safety of milk thistle 
seed extract (silymarin) when used as a supplemental ingredient in foods.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant p est 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) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  G/SPS/N/CAN/1459  
 
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  [ ] 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 7 October 2022 (available in English and French):  
https://www.canada.ca/en/health -canada/servi ces/food -nutrition/public -involvement -
partnerships.html  
https://www.canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats.html  
10. Proposed date of adoption (dd/mm/yy) : The proposed supplemental ingredient will be 
legally enabled once published in Health Canada's List of permitted supplemental 
ingredients  (https://www.canada.ca/en/health -canada/services/food -
nutrition/supplemented -foods/technical -documents/list -permitted -food-ingredients.html ). 
Proposed date of publication (dd/mm/yy) :  
11. Proposed date of e ntry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : The supplemental ingredient modification noted in this document come 
into force the day they are made to the List of permitted supplemental ingredients  
(https://www.canada.ca/en/health -canada/services/food -nutrition/supplemented -
foods/technical -documents/list -permitte d-food-ingredients.html ). 
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 20 December 2022  
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 "Health Canada's Proposal to enable the use of milk thistle seed extract (silymarin) as 
a supplemental ingredient in foods" is available through the following weblink:  
https://canada.ca/en/health -canada/services/food -nutrition/public -involvement -
partnerships/notice -proposal -enable -use-milk-thistle -seed-extract -supplemental -
ingredient -foods/document.html  (English)  
https://canada.ca/fr/sante -canada/services/aliments -nutrition/participation -public -
partenariats/avis -proposition -utilisation -extrait -graines -chardon -marie -ingredient -
supplementaire -aliments/document.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