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