Here is a quick breakdown of what you need to know to stay compliant:

1.The ‘Flexible Approach’ for CNF Submissions

In most cases, companies are no longer required to provide the exact concentration or concentration range on the CNF for fragrance allergens. However, there is a major exception:

• If a fragrance allergen has a specific concentration-related condition listed on the Cosmetic Ingredient Hotlist, providing the exact concentration or range remains mandatory.

2. Reminder: Mandatory Labeling Requirements (April 12, 2026)

Starting April 12, 2026, fragrance allergens must be disclosed within the ingredient list on cosmetic labels if they exceed the following thresholds:

• 0.001% for leave-on products
• 0.01% for rinse-off products

This change is designed to help consumers with known allergies make informed, safe purchasing decisions.

3. Changes to the Cosmetic Notification Form (Section 5)

To accommodate these updates, Section 5 of the CNF has been revised:

• The ‘Fragrance Allergen’ checkbox has been renamed to ‘Fragrance allergen present above the disclosure threshold’.
• You must enter one fragrance allergen per ingredient line and check this box if the concentration exceeds the limits mentioned above.
• While the flexible approach allows for less details on the CNF, Health Canada still encourages manufacturers and importers to provide exact concentrations when possible.

Navigating these new regulatory thresholds can be complex. Contact us if you need assistance submitting CNFs or performing label reviews to stay compliant. 

The post Updates to the Cosmetic Notification Form appeared first on Focal Point.

Proposed Additions (New Restrictions):

The following ingredients are being added to the Hotlist with specific usage limits:

-Basic Violet 4 (CI 42600, CAS 2390-59-2)

• Prohibited in leave-on hair products
• Restricted to a maximum of 0.4% in hair dyes and 0.2% in rinse-off hair care products

-Basic Blue 7 (CI 42595, CAS 2390-60-5)

• Prohibited in leave-on hair products
• Restricted to maximum concentrations in hair dyes (0.4%), rinse-off hair care (0.2%), nail products (0.8%), and bath products (2%).

-Polyaminopropyl Biguanide (PHMB) (CAS CAS 32289-58-0; 27083-27-8; 28757-47-3)

• Prohibited in spray or aerosol formulations due to lung risks from inhalation
• Restricted to a maximum of 0.2% in all other cosmetics

Proposed Revisions to Existing Entries:

Health Canada is proposing revisions for the following listed ingredients:

-Symphytum spp. (Comfrey)

• Prohibited: The current exception for Symphytum officinale is being removed, banning the use of this ingredient due to concerns over toxic alkaloids.

-Brucine and its salts (CAS 357-57-3; 4845-99-2)

• Prohibited: Previously restricted, this ingredient is now proposed for a total ban due to high toxicity and neurotoxic risks.

-Furocoumarins (CAS 66-97-7; 482-44-0; 642-05-7; 484-20-8; 298-81-7)

• Restricted: Intentionally adding these is not permitted.
• New Limits: Permitted only as trace contaminants in naturally occurring plant extracts, with a limit of 1 ppm (0.0001%) in all leave-on products (expanding the rule beyond just sun-tanning products).

-Imperatorin

• Removed: The specific entry for this ingredient will be removed as it will now be regulated under the broader ‘Furocoumarins’ entry.

Stakeholders are encouraged to submit comments on the changes Health Canada is proposing. The comments can be emailed or sent in writing to the Hotlist Coordinator no later than February 17, 2026. At this time, you should be evaluating your market strategy should you have products impacted by these potential updates to the Hotlist, as you will be required to comply once updates to the Hotlist are published. Should you require assistance with regulatory compliance, do not hesitate to reach out to us.

The post Health Canada Proposed Updates to the Cosmetic Ingredient Hotlist appeared first on Focal Point.

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:

1. Basic Violet 4 and Basic Blue 7: Previously deemed low risk, these dyes now pose potential carcinogenic concerns due to increased use in cosmetics. 
2. 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:

1. Symphytum spp., with the exception of Symphytum officinale: Health Canada is proposing a complete prohibition, including Symphytum officinale, due to newly confirmed toxic alkaloids.
2. 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.
3. Imperatorin: Proposed for removal as a standalone entry and instead grouped under existing Furocoumarins restriction.

Restrictions:

1. 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.

The post Stakeholder Feedback Invited: Health Canada Proposes Updates to Cosmetic Ingredient Hotlist appeared first on Focal Point.