On 14 May 2025, Health Canada issued a Notice to Stakeholders regarding its review of the Cosmetic Ingredient Hotlist. While not a formal consultation, this notice serves as an early warning to cosmetic manufacturers, distributors, and other industry stakeholders about potential upcoming changes to the Hotlist.
What is the Cosmetic Ingredient Hotlist?
The Cosmetic Ingredient Hotlist (the “Hotlist”) is an administrative tool curated by Health Canada that outlines substances either prohibited or restricted in cosmetic products sold in Canada. Although it is not a regulation or law in itself, the Hotlist supports the enforcement of Section 16 of the Food and Drugs Act (FDA), which prohibits the sale of cosmetic products that may pose a risk to human health.
The Hotlist also identifies substances that lack a cosmetic function, suggesting that a product containing them may not meet the legal definition of a cosmetic under Canadian law.
It is important to note that the Hotlist, while comprehensive, is not exhaustive. An ingredient can still be deemed unsafe by Health Canada even if it has not yet been listed.
Proposed additions and revisions to the Hotlist
Health Canada is proposing new restrictions for the following substances, primarily due to updated data on health risks and exposure:
- Basic Violet 4 – Basic Violet 4 will be proposed for addition to the list of substances described as restricted due to potential carcinogenicity. The concentrations limit may vary depending on the product type.
- Basic Blue 7 – Similar restrictions as those proposed for Basic Violet 4.
- Polyaminopropyl Biguanide (PHMB) – The substance will be proposed for addition to the list of substances described as restricted. A proposed ban in spray cosmetics due to inhalation risks is also being considered.
Additionally, Health Canada is proposing revising the following entries:
- Symphytum spp. – S. officinale will no longer be an exception to the ban, as toxic compounds have been detected.
- Brucine – Reclassified from “restricted” to “prohibited” due to its high toxicity and risk of absorption.
- Imperatorin – Removed as an individual entry and included under furocoumarins, which share similar phototoxicity risks.
- Furocoumarins – A revision to ban intentionally added Furocoumarins is being considered. Only trace amounts from plant extracts will be allowed.
Next steps for brand-owners
This notice marks the beginning of a pre-consultation phase, which should last around three months. During this time, companies involved in the manufacture, import, or sale of cosmetics in Canada are encouraged to:
- Identify products that could be impacted
- Prepare for potential formulation, labeling, or distribution changes
Following this period, Health Canada will launch a 60-day public consultation on the proposed changes. After reviewing and responding to the comments received, Health Canada will finalise and publish the updated Hotlist.
Do you have questions on compliance of cosmetics in Canada? Contact us here or at coslaw@obelis.net.
References
Health Canada. (2025). Notice to Stakeholders concerning review of the Cosmetic Ingredient Hotlist. Retrieved on 15 May 2025.
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