Health Canada Issues Notice to Stakeholders on Proposed Revisions to the Cosmetic Ingredient Hotlist

"Health Canada has released a Notice to Stakeholders regarding potential updates to the Cosmetic Ingredient Hotlist (Hotlist), informing industry and stakeholders about substances under consideration for inclusion or revision in future updates. This notice is not part of a formal consultation process, and Health Canada will not respond to comments received at this stage. 1. Proposed Additions to the Hotlist (3): Restrictions: (a)Basic Violet 4 Proposed for addition to the restricted list due to potential carcinogenicity. At the time of the CMP assessment, risk to health was low, but increased exposure from cosmetics now poses a potential risk. Restrictions being considered: Limit use to specific cosmetic product types with maximum permitted concentrations. (b)Basic Blue 7 Also proposed for restriction due to potential carcinogenicity. Similar to Basic Violet 4, previously low risk but recent exposure increases now raise concern. Restrictions being considered: Limit use to certain product types with specified maximum concentrations. (c)Polyaminopropyl Biguanide (PHMB) CAS Nos.: 32289-58-0, 27083-27-8, 28757-47-3 Proposed for restriction due to risks related to lung function and skin sensitization. Restrictions being considered: Prohibit use in spray formulations (due to inhalation risk). Allow in other topically applied products with maximum permitted concentrations (to address skin sensitization). 2.Proposed Revisions to Existing Entries on the Hotlist (4): -Prohibitions: (a)Symphytum spp., including Symphytum officinale Revision proposed: Remove the current exception for Symphytum officinale. Reason: Detection of echimidine and other carcinogenic pyrrolizidine alkaloids such as lasiocarpine in its derivatives. (b)Brucine Currently restricted, but proposed to be reclassified as prohibited. Reason: High acute toxicity, neurotoxicity, and significant dermal absorption. Also, current data are insufficient to evaluate long-term exposure risks. Expansion of entry: May include brucine and its salts, such as brucine sulfate, due to similar toxicity profiles. (c)Imperatorin Currently prohibited with a specific entry. Revision proposed: Remove the specific entry and instead regulate it under the broader category of Furocoumarins, due to phototoxic and photomutagenic properties. -Restrictions: (a)Furocoumarins (except those naturally occurring in plant extracts) Revision proposed: Clarify that Furocoumarins may not be intentionally added as ingredients. Only trace amounts naturally present in plant extracts would be permitted Due to phototoxicity, photomutagenicity, and photocarcinogenicity when combined with UVA exposure. Maximum permitted concentration would apply to all leave-on products, not just sun-tanning products. 3.Other Miscellaneous Revisions: Updates may include: New substance synonyms Additional CAS numbers Minor corrections (e.g., fixing typos) Chemicals Management Plan (CMP) – Ingredients Under Evaluation: -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 "