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[Updated] Health Canada Approves Milk Thistle Seed Extract as New Supplemental Ingredient

Editor's note: This article was originally published on January 17, 2025, and was updated on February 5, 2025, as per the latest developments. 

January 30, 2025

On January 30, 2025, Health Canada issued M-SIS-25-02, modifying the List of Permitted Supplemental Ingredients. This modification newly permits the use of milk thistle seed extract (silymarin), with immediate effect.

Use Requirements for Milk Thistle Extract (Silymarin) 

Permitted in

Foods belonging to a category set out in the List of Permitted Supplemented Food Categories

Maximum amounts and units per serving of stated size

200 mg silymarin

Cautionary statements required on the label

(a) All products containing milk thistle seed extract (silymarin) require the cautionary statements:

  • "For Adults only (18 years of age or older)";

  • "Not recommended for pregnant or breastfeeding women";

  • "Do not [eat/drink] on the same day as any other supplemented foods or supplements with [the same supplemental ingredients/(name specific ingredients)]";

  • "Not recommended for individuals with allergy to plants in the aster family".

(b) If the amount of silymarin declared on the label is more than 120 mg per serving, the following additional cautionary statement is required:

"Do not eat/drink more than X container(s)/serving(s) daily", where X is a number of servings that provides a daily amount of silymarin, based on the amount declared on the label, that does not exceed 600 mg.

Others

Milk thistle seed extract (silymarin) is a dry extract, fluid extract, tincture, decoction, or infusion of Silybum marianum (L.) Gaertn. seeds and:

a. must be obtained using an extraction solvent used in accordance with the List of Permitted Carrier or Extraction Solvents or water; and

b. must contain at least 65% silymarin; and

c. must not contain more than 80% silymarin.

The amount in milligrams of silymarin from milk thistle seed extract must be declared under the "Supplemented with" heading in the Supplemented Food Facts table.


January 16, 2025


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