Notice of Health Canada’s proposal to enable the use of milk thistle seed extract (silymarin) as a supplemental ingredient in foods

October 7, 2022

Background

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 in the Notice of Proposal information document referenced below.

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 scientific information relevant to the safety of milk thistle seed extract (silymarin) when used as a supplemental ingredient in foods.

Information Document(s)

Health Canada's Proposal to Enable the Use of Milk Thistle Seed Extract (silymarin) as a Supplemental Ingredient in Foods – Reference Number: NOP/ADP SI-004

To obtain an electronic copy of Health Canada's summary of the safety assessment for the use of milk thistle seed extract as a supplemental ingredient, please contact our publications office or send an e-mail to publications-publications@hc-sc.gc.ca with the subject heading "HPFB BNS Milk Thistle Seed Extract_EN".

Contact Information

Health Canada's Food Directorate is committed to reviewing new scientific information on the safety in use of any permitted supplemental ingredient, including milk thistle seed extract (silymarin). Anyone wishing to submit new scientific information on the supplemental ingredient use of milk thistle seed extract (silymarin) or to submit inquiries may do so in writing, by regular mail or electronically. If you wish to contact the Food Directorate electronically, please use the words "Milk Thistle Seed Extract (NOP/ADP SI-004)" in the subject line of your e-mail. Health Canada is able to consider information received by December 20, 2022, 75 days from the date of this posting.

Supplemented Foods:

Bureau of Nutritional Sciences, Food Directorate
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2203E
Ottawa, Ontario K1A 0K9
E-mail: supplementedfoods-alimentssupplementes@hc-sc.gc.ca

Supporting Information

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