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Health Canada Opens Consultation on the Cosmetic Ingredient Hotlist (November 2025)
On November 19, 2025, Health Canada announced a public consultation to update the Cosmetic Ingredient Hotlist, the country’s reference list of ingredients prohibited or restricted in cosmetics.
This update aims to reflect the latest toxicological data and risk assessments under the Chemicals Management Plan (CMP).
For cosmetic brands, importers, and formulators, these changes are a critical reminder of the importance of regulatory vigilance and ingredient compliance when marketing products in Canada.
What Is the Cosmetic Ingredient Hotlist?
The Cosmetic Ingredient Hotlist is a key regulatory tool under the Food and Drugs Act and Cosmetic Regulations.
It provides Health Canada’s guidance on substances that may cause a cosmetic to be non-compliant, either due to safety concerns or product misclassification (e.g., when a product may be considered a drug or therapeutic product).
Although not legally binding on its own, the Hotlist serves as a primary reference for compliance reviews, and inspectors routinely refer to it when assessing whether a cosmetic product meets Canadian safety requirements.
Proposed 2025 Additions to the Cosmetic Ingredient Hotlist
The new consultation proposes three key ingredients to be added to the restricted list and several revisions to existing entries.
New Restricted Ingredients
| Ingredient | Proposed Restriction | Reason |
|---|---|---|
| Basic Violet 4 | Banned in leave-on hair products. Allowed in rinse-off dyes (0.2–0.4%). | Potential carcinogenicity |
| Basic Blue 7 | Prohibited in leave-on hair products. Allowed in hair dyes (0.2–0.4%), nails (0.8%), bath products (≤ 2%). | Toxicological concerns |
| Polyaminopropyl Biguanide (PHMB) | Not permitted in sprays/aerosols; ≤ 0.2% in other formulations. | Inhalation and sensitization risk |
These proposed additions align Canada’s Hotlist with global safety trends observed in the EU Cosmetics Regulation (EC 1223/2009) and recent Scientific Committee on Consumer Safety (SCCS) opinions.
Revisions to Existing Hotlist Entries
Health Canada also plans to revise or expand existing prohibitions and restrictions to ensure consistency and updated chemical identification.
Proposed Revisions Include:
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All Comfrey species (Symphytum) – Full prohibition of all species due to pyrrolizidine alkaloid toxicity.
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Brucine and its salts – Moved from restricted to prohibited category for acute toxicity and neurotoxicity concerns.
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Imperatorin – Reclassified under the broader furocoumarins category to harmonize phototoxicity controls.
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Furocoumarins (added intentionally) – Fully prohibited; trace levels only allowed when naturally present in plant extracts.
These updates emphasize Health Canada’s precautionary approach and its alignment with international safety assessments.
How These Changes Affect Cosmetic Manufacturers and Importers
Cosmetic companies selling in or exporting to Canada should:
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Review ingredient portfolios to identify affected substances.
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Update formulations and labels before final implementation.
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Submit comments to Health Canada before February 17, 2026, if supporting toxicological data is available.
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Consult a compliance expert such as Cosmereg to conduct ingredient screening, Hotlist cross-checks, and cosmetic notifications.
How Cosmereg Helps You Stay Compliant with Canada’s Cosmetic Regulations
As a regulatory partner trusted by global cosmetic brands, Cosmereg provides complete Canada cosmetic compliance support, including:
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Ingredient review and Hotlist compliance checks
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Cosmetic Notification Form (CNF) submission
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Label review and bilingual (English/French) compliance
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Risk assessment and documentation alignment for Health Canada
Cosmereg ensures that your formulations meet Health Canada Cosmetic Regulations, minimizing compliance risks and preventing enforcement delays.
Conclusion: Prepare Early for the 2025 Hotlist Changes
The 2025 Cosmetic Ingredient Hotlist consultation is an important signal that Health Canada continues to strengthen cosmetic safety oversight.
Brands should act proactively, audit formulations, consult experts, and anticipate reformulation where needed — to ensure smooth market access in Canada.
By partnering with Cosmereg, your business can navigate these updates confidently and maintain full regulatory compliance across global markets.
