Health Canada's authorizes that of milk thistle seed extract as a supplemental ingredient in supplemented foods
Canada
Feb 06, 2025
Health Canada's Food and Nutrition Directorate assessed milk thistle seed extract (MTE) for safety, based on publicly available information. The Food and Nutrition Directorate concluded that there was sufficient information to establish conditions under which standardized MTE could be consumed safely as a supplemental ingredient in supplemented foods. Consequently, Health Canada will permit the use of milk thistle seed extract (silymarin) as a supplemental ingredient in supplemented foods under certain conditions. The conditions are outlined in the Notice of Modification.
To propose future, additional changes to the conditions of use for milk thistle seed extract (silymarin) as a supplemental ingredient, stakeholders can submit a pre-market request to the Food and Nutrition Directorate as described in the Guidance document: Pre-market submission process for supplemented foods. Manufacturers and distributors are encouraged to request a pre-submission consultation with the Food and Nutrition Directorate to seek additional guidance so that a complete submission can be filed at the outset, potentially reducing the number of requests to the applicant for clarification or additional information, or preventing the submission from being rejected for incompleteness.
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