Canada proposes to update the list of prohibited and restricted ingredients in cosmetics（Hotlist）

Canada proposes to update the list of prohibited and restricted ingredients in cosmetics（Hotlist）

 On May 14, 2025, Health Canada issued a notice proposing updates to the Cosmetic Ingredient Hotlist (hereinafter referred to as the "Hotlist").  The notice publicized a list of substances under consideration for addition to, or modification within, the Hotlist.

The Canadian Hotlist assists manufacturers and other stakeholders in identifying substances in cosmetics that may contravene Section 16 of the Food and Drugs Act or the general prohibition clauses within the Cosmetic Regulations.  Its core function is to safeguard cosmetic compliance and consumer safety by clearly defining prohibited and restricted ingredients.

This notice outlines three key areas of proposed change:

I. Proposed Additions to the Hotlist:

Basic Violet 4:  Based on assessments under the Chemical Management Plan (CMP) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and considering its potential carcinogenicity, Basic Violet 4 is proposed for inclusion as a restricted substance. Its use in cosmetics would be limited to specific product types (not publicly disclosed in this notice), with maximum permitted concentrations defined for those types.

Basic Blue 7:  Similar to Basic Violet 4, based on CMP assessments under CEPA 1999 and its potential carcinogenicity, Basic Blue 7 is proposed for inclusion as a restricted substance.  Its use would be limited to specific product types (not publicly disclosed), with maximum permitted concentrations specified.

Polyaminopropyl Biguanide (PHMB): Based on CMP assessments under CEPA 1999, PHMB is proposed for inclusion as a restricted substance.  A complete ban on PHMB in cosmetic spray formulations is under consideration due to potential lung function impacts from inhalation via mists, vapors, or aerosols. For other topical products where inhalation exposure is not possible, a maximum permitted concentration is proposed due to skin sensitization risks.

II. Proposed Revisions to Existing Hotlist Entries:

A. Prohibited List:

Symphytum spp., with the exception of Symphytum officinale:  A revision is proposed to remove the exemption for Symphytum officinale, effectively including all Symphytum species in the prohibited list.

Brucine: Currently listed as a restricted substance, Brucine is proposed for reclassification as a prohibited substance due to its high acute toxicity, known neurotoxicity, and significant potential for dermal absorption.  The entry is also proposed to be expanded to include Brucine salts, anticipating similar toxicity based on the ability of brucine sulfate to decompose and release brucine ions.

Imperatorin: Currently listed as prohibited, Imperatorin is proposed for removal from the Hotlist.  Its regulation would instead be incorporated under the existing entry for furocoumarins.

B. Restricted List:

Furocoumarins, except for naturally occurring in plant extracts:  A revision is proposed to clarify that furocoumarins are not permitted as intentionally added ingredients and are only allowed in trace amounts when naturally occurring in plant extracts.

III. Other Revisions:

In addition to the above changes, further revisions to existing entries may be made, including the addition of new synonyms, Chemical Abstracts Service Registry Numbers (CAS RNs), and other minor corrections such as spelling errors.

Important Note: The substances and restrictions mentioned in this notice are not yet officially incorporated into the Cosmetic Ingredient Hotlist.  However, Canadian businesses involved in cosmetic exports should review this notice to determine which products may be affected by these proposed updates.  Proactive adjustments to product formulations or business plans may be necessary to ensure compliance with any forthcoming regulatory changes.