21 October 2024
Canada - Notice to Stakeholders concerning review of the Cosmetic Ingredient Hotlist
May 2025 - Health Canada has issued a notice outlining potential updates to the Cosmetic Ingredient Hotlist.
Health Canada is considering several updates to the Cosmetic Ingredient Hotlist under the Chemicals Management Plan (CMP) and the Canadian Environmental Protection Act, 1999 (CEPA 1999). These updates reflect evolving scientific evidence and cosmetic product use patterns. The proposed changes have been communicated through a Notice to Stakeholders, this last include both new prohibitions and modifications to existing restrictions.
As a reminder, a Notice to Stakeholders is typically issued around three months prior to public consultation. During this pre-consultation phase, companies should assess whether their products may be impacted and prepare for necessary formulation or distribution adjustments. Afterward, proposed changes will be posted for a 60-day consultation period, followed by a final response from Health Canada and the publication of the revised Hotlist.
Proposed Prohibitions
Symphytum spp., including Symphytum officinale
A revision is being considered to remove the current exception for Symphytum officinale from the prohibition on Symphytum species. Although S. officinale was previously excluded based on older data suggesting it lacked echimidine (a hepatotoxic alkaloid), recent findings confirm its presence in some S. officinale derivatives. The plant is also known to contain other carcinogenic pyrrolizidine alkaloids, such as lasiocarpine.
Brucine and its salts
Currently listed as restricted, Brucine is under consideration for reclassification as a prohibited substance. This change is based on its high acute toxicity, neurotoxic properties, and significant dermal absorption potential. There is also insufficient data to assess the long-term health effects of repeated exposure. The revised entry would also extend the prohibition to include Brucine salts, such as Brucine sulfate, which are expected to have similar toxicological profiles due to their ability to release Brucine ions.
Imperatorin
The current individual prohibition of Imperatorin may be removed from the Hotlist. Instead, Imperatorin would fall under the general prohibition on furocoumarins, given its similar phototoxic and photomutagenic effects when combined with UVA exposure.
Proposed Restrictions
Basic Violet 4
Basic Violet 4 is being considered for addition to the restricted substances list due to potential carcinogenicity. While earlier CMP assessments deemed health risks low at previously reported exposure levels, more recent cosmetic notifications indicate increased use, potentially raising risk. Restrictions under consideration include permitted use only in specific product types and with defined maximum concentrations.
Basic Blue 7
Similarly, Basic Blue 7 is proposed for addition to the restricted list, based on increased exposure levels and associated health concerns. As with Basic Violet 4, its use would be limited to certain product categories, subject to concentration limits.
Polyaminopropyl Biguanide (PHMB)
PHMB (CAS Nos. 32289-58-0; 27083-27-8; 28757-47-3) is also proposed for restriction. Health Canada is considering banning its use in spray formulations due to potential respiratory risks. For non-inhalation cosmetic formats, restrictions may include maximum allowable concentrations due to its skin sensitization potential.
Furocoumarins (except when naturally occurring in plant extracts)
A revision to this entry would clarify that furocoumarins are not permitted as added ingredients and are only acceptable at trace levels when naturally present in plant extracts. Given their known phototoxic, photomutagenic, and photocarcinogenic properties, the proposed change would extend the current concentration limit to all leave-on products, not just sun-tanning products, due to potential UVA exposure after application.
Ingredients Under Evaluation — CMP Process
The following groups of substances are under evaluation as part of the Chemicals Management Plan (CMP). While they may not appear in the upcoming consultation, future Hotlist changes are possible if risks are confirmed in final assessments. Stakeholders are encouraged to monitor these developments and subscribe to CMP updates:
- Acyclic, Monocyclic, and Bicyclic Monoterpenes Group
- Alcohols Group
- Boric Acid, its Salts, and Precursors
- Fourteen Terpene and Terpenoid Substances Group
- Gas Oils and Kerosenes with Uses in Consumer Products
- Low Boiling Point Naphthas Group
- Monocyclic and Bicyclic Sesquiterpenes Group
- Parabens Group
- Phenylpropanoids and Aldehydes Group
- Salicylates Group
- Tricyclic Sesquiterpenes and Triterpenoids Group
We will continue to monitor Health Canada’s updates and provide further details as official decisions are announced. Please let us know if you would like assistance reviewing ingredient portfolios for compliance with these proposed changes.
More information is available here.
Author
Pierre Verachten
Pierre Verachten is Biorius's Cosmetic International Compliance Lead and has been working in the cosmetic industry for more than 10 years.
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21 October 2024
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