Proposed updates to the Cosmetic Ingredient Hotlist: Prohibited and restricted ingredients
Health Canada is proposing to update the Cosmetic Ingredient Hotlist. Updates include additions, changes to the conditions for existing entries and changes to include new substance identifiers or make minor corrections.
On this page
- Background
- Proposed additions
- Proposed revisions to existing entries
- Additional information
- Provide feedback
Background
The Cosmetic Ingredient Hotlist is used to inform manufacturers and others that certain substances, when present in a cosmetic, may contravene either:
- the general prohibition found in section 16 of the Food and Drugs Act (FDA) or
- a provision of the Cosmetic Regulations
The Hotlist may also communicate that the presence, or use under specific conditions, of certain substances may also make the product unsuitable for classification as a cosmetic under the FDA.
Health Canada updates the Hotlist periodically, as needed. The last update to the Hotlist was in August 2025.
The Hotlist is not exhaustive. Those selling cosmetics must not wait for a regulatory or Hotlist update to comply with the general prohibition. To comply with section 16 of the FDA, the sale of a cosmetic should stop as soon as it's known that the cosmetic may cause injury.
Proposed updates to the Hotlist are put forward as needed and conclusions are based on weight of evidence. This evidence includes recognized scientific journals and the opinions or decisions of national or international counterparts and expert panel groups.
We are proposing the following updates to the Hotlist for consultation over a 90-day comment period. General information and consultation timelines are available here:
Proposed additions
Restrictions
Basic Violet 4: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), we propose to add Basic Violet 4 to the list of substances described as restricted due to potential carcinogenicity. At the time of the CMP assessment, Basic Violet 4 was associated with health effects of concern but at levels of exposure considered in the assessment, the risk to human health was considered low. However, based on cosmetic notifications submitted to Health Canada after the assessment period, levels of exposure have increased and may now pose a risk. Conditions proposed include a prohibition for leave-on hair products and maximum permitted concentrations for certain other hair product types.
| Ingredient information | Restrictions | ||||
|---|---|---|---|---|---|
| Chemical | CAS (including but not limited to) | Synonyms and Related Compounds (including but not limited to) | Conditions of Use by product type | Maximum Concentration Permitted | Warnings and Cautionary Statements (to the effect of) |
Basic Violet 4 |
2390-59-2 |
CI 42600 |
Not permitted for use in leave-on hair products |
||
Hair dye products |
0.4% |
||||
Rinse-off hair care products |
0.2% |
||||
Other cosmetics |
|||||
Basic Blue 7: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), we propose to add Basic Blue 7 to the list of substances described as restricted due to potential carcinogenicity. At the time of the CMP assessment, Basic Blue 7 was associated with health effects of concern but at levels of exposure considered in the assessment, the risk to human health was considered low. However, based on cosmetic notifications submitted to Health Canada after the assessment period, levels of exposure have increased and may now pose a risk. Conditions proposed include a prohibition for leave-on hair products and maximum permitted concentrations for certain other product types.
| Ingredient information | Restrictions | ||||
|---|---|---|---|---|---|
| Chemical | CAS (including but not limited to) | Synonyms and Related Compounds (including but not limited to) | Conditions of Use by product type | Maximum Concentration Permitted | Warnings and Cautionary Statements (to the effect of) |
Basic Blue 7 |
2390-60-5 |
CI 42595 |
Not permitted for use in leave-on hair products |
||
Hair dye products |
0.4% |
||||
Rinse-off hair care products |
0.2% |
||||
Nail products |
0.8% |
||||
Bath products |
2% |
||||
Other cosmetics |
|||||
Polyaminopropyl Biguanide: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), we propose to add Polyaminopropyl Biguanide (CAS 32289-58-0; 27083-27-8; 28757-47-3, also known as PHMB) to the list of substances described as restricted. Prohibition of PHMB in cosmetic spray formulations is being proposed since inhaling products that contain PHMB and create mists, vapours or aerosols may affect lung function. For other, topically applied products where exposure by inhalation is not possible, maximum permitted concentrations are proposed due to risk of skin sensitization.
| Ingredient information | Restrictions | ||||
|---|---|---|---|---|---|
| Chemical | CAS (including but not limited to) | Synonyms and Related Compounds (including but not limited to) | Conditions of Use by product type | Maximum Concentra-tion Permitted | Warnings and Cautionary Statements (to the effect of) |
Polyaminopro-pyl Biguanide |
32289-58-0; |
Polyhexamethylenebiguanide; |
Not permitted for use in spray or aerosol formulations |
||
Other cosmetics |
0.2% |
||||
Proposed revisions to existing entries
Prohibitions
Symphytum spp., with the exception of Symphytum officinale: We propose to revise the entry to remove the exception for Symphytum officinale. It was previously excepted from the entry as past studies suggested it did not contain echimidine, a hepatotoxic alkaloid. However, echimidine has since been detected in some S. officinale derivatives, and S. officinale is also known to contain other carcinogenic pyrrolizidine alkaloids, such as lasiocarpine.
| Ingredient | CAS (including, but not limited to) | Synonyms and related compounds (including, but not limited to) |
|---|---|---|
Symphytum spp., |
Comfrey |
Brucine: Brucine is currently described as restricted on the Hotlist. We propose to revise the entry to describe it as prohibited due to its high acute toxicity, known neurotoxic properties and significant potential for dermal absorption. Additionally, available information is considered insufficient to address potential long-term adverse health effects from repeated exposure to cosmetic products containing brucine. We also propose to expand the entry from Brucine to Brucine and its salts, as the toxicity of salts, such as brucine sulfate, is anticipated to be similar to that of brucine based on their ability to dissociate and release brucine ions.
| Ingredient | CAS (including, but not limited to) | Synonyms and related compounds (including, but not limited to) |
|---|---|---|
Brucine and its salts |
357-57-3; |
Brucine Sulfate |
Imperatorin: We propose to remove the specific Hotlist entry for Imperatorin, which is currently described as prohibited. Imperatorin is considered subject to the entry for Furocoumarins (described as restricted), and will be added as a synonym to the entry. Imperatorin is expected to have phototoxic and photomutagenic effects similar to other furocoumarins.
Restrictions
Furocoumarins, except for naturally occurring in plant extracts: We propose to revise the entry to indicate Furocoumarins are not permitted to be added to products as ingredients and would only be permitted at trace amounts when naturally occurring in plant extracts. Furocoumarins have been associated with phototoxicity, photomutagenicity and photocarcinogenicity reactions when combined with exposure to UVA radiation. The current maximum permitted concentration is proposed to apply to all leave-on products, not just sun-tanning products, because sun exposure may occur following the use of any leave-on cosmetic product.
| Ingredient information | Restrictions | ||||
|---|---|---|---|---|---|
| Chemical | CAS (including but not limited to) | Synonyms and Related Compounds (including but not limited to) | Conditions of Use by product type | Maximum Concentration Permitted | Warnings and Cautionary Statements (to the effect of) |
Furocoumarins |
66-97-7; |
Psoralen; |
Not permitted for use as intentionally added ingredients |
||
Leave-on products, when naturally occurring in plant extracts |
0.0001% (1ppm) |
||||
Rinse-off products, when naturally occurring in plant extracts |
|||||
Other miscellaneous revisions
Several existing entries will be revised to include new synonyms and Chemical Abstract Service Registry (CAS) numbers or make minor corrections.
Additional information
Additional information on the ingredients included in this consultation are available upon request. Please send an email to cosmetics@hc-sc.gc.ca requesting the documents. This may provide a more comprehensive understanding of the risk factors considered during the development of the proposed Hotlist conditions.
Provide feedback
Health Canada invites stakeholders to submit comments on the changes we're proposing.
Please supply evidence to support your comments, if possible.
Provide your comments no later than February 17, 2026, by email or in writing to:
Hotlist Coordinator
Cosmetics Program
Consumer and Hazardous Products Safety Directorate
Health Canada
219 Laurier Ave West
Ottawa ON K1P 5J6
Email: cosmetics@hc-sc.gc.ca
Submitted comments will be reviewed and will receive a response. Upon final publication, a notice will be sent to subscribers of the cosmetics mailing list, and to those who have previously submitted a cosmetic notification form.
We invite you to:
- refer to Consumer Product Safety for up-to-date information
- subscribe to the cosmetics mailing list for news and information on our work in the area of cosmetics