Health Canada has issued a notice to Stakeholders regarding proposed updates to the Cosmetic Ingredient Hotlist. This notice is not a formal consultation process; however, Health Canada invites stakeholders to provide safety information or other considerations about the proposed updates. This notice will help determine which of the products could be impacted by the possible updates and stakeholders can begin to think about the necessary changes to product formulations, distribution and sales.
A formal consultation will follow, during which proposed updates will be posted for a 60-day comment period. After evaluating the information and comments received, Health Canada will publish the revised Hotlist.
Proposed Additions:
Health Canada is considering adding the following ingredients (restrictions) to the Hotlist:
- Basic Violet 4 and Basic Blue 7: Previously deemed low risk, these dyes now pose potential carcinogenic concerns due to increased use in cosmetics.
- Polyaminopropyl Biguanide (PHMB): Proposed restrictions include banning it in spray formulations and limiting concentrations in topical products due to respiratory and skin sensitization risks.
Proposed Revisions to the existing entries:
Prohibitions:
- Symphytum spp., with the exception of Symphytum officinale: Health Canada is proposing a complete prohibition, including Symphytum officinale, due to newly confirmed toxic alkaloids.
- Brucine: Currently described as restricted on the Hotlist. Due to its toxicity and absorption risk, it’s now considered for full prohibition. An expansion of the entry to Brucine and its salts is also being considered.
- Imperatorin: Proposed for removal as a standalone entry and instead grouped under existing Furocoumarins restriction.
Restrictions:
- Furocoumarins , except for naturally occurring in plant extracts: A revision is 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. The current maximum permitted concentration would be proposed to apply to all leave-on products, not just sun-tanning products.
Other Miscellaneous Revisions:
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 following ingredients are being assessed under the CMP due to the potential risks associated with cosmetic usage. There might be future changes to the Hotlist if the risks 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.
- 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
To view the full notice, please visit the Health Canada website.
If you require any assistance, have any questions or would like to understand more about how this impacts your business, please do reach out to us.
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