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.
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