Notice to Stakeholders concerning review of the Cosmetic Ingredient Hotlist

The purpose of this notice is to inform you of substances that Health Canada is considering for inclusion in future updates to the Cosmetic Ingredient Hotlist (Hotlist). The notice includes the following:

• Proposed additions to the Hotlist
• Proposed revisions to existing entries on the Hotlist
• Other miscellaneous revisions (for example, inclusion of additional substance identifiers or minor corrections)

This notice is not a formal consultation process, Health Canada will not respond to the information or comments received at this stage.

Background

The Hotlist is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene the general prohibition found in section 16 of the Food and Drugs Act (FDA) or a provision of the Cosmetic Regulations. In addition, the Hotlist communicates that certain substances, with no known cosmetic or functional purpose in a cosmetic formulation, make it unlikely for the product to meet the definition of a cosmetic under the FDA. The Hotlist is not exhaustive, and those selling cosmetics must not wait for a regulatory or Hotlist update to comply with the general prohibition. The sale of a cosmetic should stop as soon as it is 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. Information is gathered through a review of recognized scientific journals, as well as opinions or decisions made by national or international counterparts and expert panel groups. The last update to the Hotlist was in February 2025.

The Notice to Stakeholders is issued approximately three months prior to the consultation on proposed updates to the Hotlist. During this time, Health Canada expects that those selling cosmetics in Canada will start to determine which of their products could be impacted by the possible updates, and begin to think about the necessary changes to product formulations, distribution and sale. Following this time period, proposed updates to the Hotlist will be posted for consultation for a 60-day comment period. After this consultation period, Health Canada will respond to the comments received. Following evaluation of information and comments received during the consultation, the revised Hotlist will be posted on the website. Additionally, a notice will be sent to subscribers to the Cosmetics Mailing List as well as all notifiers that have previously submitted a cosmetic notification form.

Proposed Additions to the Hotlist (3)

Restrictions:

1. Basic Violet 4: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), Basic Violet 4 will be proposed for addition 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, however at levels of exposure considered in the assessment, the risk to human health was considered low. Since then, based on cosmetic notifications submitted to Health Canada after the CMP assessment period, levels of exposure have increased and may now pose a risk. Conditions being considered for addition include restricting the use of Basic Violet 4 in cosmetics to certain product types, with maximum permitted concentrations for those product types.

2. Basic Blue 7: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), Basic Blue 7 will be proposed for addition 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, however at levels of exposure considered in the assessment, the risk to human health was considered low. Since then, based on cosmetic notifications submitted to Health Canada after the CMP assessment period, levels of exposure have increased and may now pose a risk. Conditions being considered for addition include restricting the use of Basic Blue 7 in cosmetics to certain product types, with maximum permitted concentrations for those product types.

3. Polyaminopropyl Biguanide: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), Polyaminopropyl Biguanide (CAS 32289-58-0; 27083-27-8; 28757-47-3, also known as PHMB) will be proposed for addition to the list of substances described as restricted. Prohibition of PHMB in cosmetic spray formulations is being considered, since inhaling PHMB through products that create mists, vapours or aerosols may affect lung function. For other topically applied products where exposure by inhalation is not possible, maximum permitted concentrations will be proposed due to risk of skin sensitization.

Proposed revisions to existing entries on the Hotlist (4)

Prohibitions:

1. Symphytum spp., with the exception of Symphytum officinale : A revision to the entry is being considered to remove the exception of Symphytum officinale. It was previously excluded 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.

2. Brucine: Brucine is currently described as restricted on the Hotlist. A revision to the entry to describe it as prohibited is being considered due to its high acute toxicity, known neurotoxic properties and significant potential for dermal absorption. Additionally, currently available information is considered insufficient to address potential long-term adverse health effects from repeated exposure to cosmetic products containing brucine. An expansion of the entry to Brucine and its salts is also being considered, 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.

3. Imperatorin: The specific Hotlist entry for Imperatorin, currently described as prohibited, is being considered for removal from the Hotlist. Imperatorin would instead be considered subject to the entry for Furocoumarins. Imperatorin is expected to have phototoxic and photomutagenic effects similar to other furocoumarins.

Restrictions:

1. Furocoumarins, except for naturally occurring in plant extracts:  A revision to the entry is being considered 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 would be 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.

Other Miscellaneous Revisions

In addition to the above changes, existing ingredient entries may be revised to include new synonyms, Chemical Abstract Service Registry (CAS) numbers as well as other minor corrections, such as fixing typos.

Chemicals Management Plan (CMP) - Ingredients under Evaluation

The ingredients listed below are being assessed under the CMP. Preliminary assessments indicate potential risks associated with cosmetic usage, which may result in future changes to the Hotlist if the proposed conclusions are confirmed in the final assessments. These ingredients may not appear in the upcoming consultation but sellers are advised to stay informed of the CMP process, and determine which of their products could be impacted. Stakeholders may subscribe to receive updates on publications, including public comment periods and consultations under the CMP.

• Acyclic, Monocyclic, and Bicyclic Monoterpenes Group
• Alcohols Group
• Boric acid, its salts and its precursors
• Fourteen Terpene and Terpenoid Substances Group
• Gas Oils and Kerosenes with Uses in Products Available to Consumers Group
• Low Boiling Point Naphthas Group
• Monocyclic and Bicyclic Sesquiterpenes Group
• Parabens Group
• Phenylpropanoids and Aldehydes Group
• Salicylates Group
• Tricyclic Sesquiterpenes and Triterpenoids Group

Please note, if at any time Health Canada receives information that indicates the potential for a serious risk concerning a product in this process, the Program will bypass the usual Hotlist update approach and take any immediate action necessary.

Stay Informed

Please refer to Consumer Product Safety for up-to-date information.

You may also subscribe to the cosmetics mailing list to receive the latest news and information about Health Canada's efforts in the area of cosmetics.