This latest order officially adds 174 substances to the NDSL. For companies manufacturing or importing chemical substances into Canada, this update provides a more streamlined regulatory environment.

Substances listed on the NDSL benefit from:

• Higher Volume Thresholds: Allowing for larger quantities to be handled before specific notification requirements are triggered.
• Streamlined Notifications: Providing a more direct and efficient path to compliance compared to substances not appearing on the list.

It is critical for stakeholders to remain aware of NDSL additions, as these changes can directly impact your notification strategy and timelines. Utilizing substances on this list often results in reduced administrative burden and faster processing for your chemical notifications.

If you need any assistance with these associated regulatory updates, our team is here to assist you.

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​Previously, navigating requirements could be complex due to the overlap with prescription drug content. The new landing page serves as a distinct resource, ensuring that NPD requirements are easily accessible and separated from other drug categories.

​Key Highlights of the New Portal

• ​The page provides comprehensive guidance covering the full product lifecycle, ranging from initial authorization to essential post-market activities.
• ​Both the Labelling Standards and Category IV Monograph pages have been refreshed with updated links and current information to ensure accuracy in submissions.
• The NNHPD has committed to updating this landing page regularly as new regulatory content and guidance documents become available.

​How We Can Help

​Navigating departmental updates and ensuring compliance can be a rigorous process. If you need any assistance with your NPD registrations, comprehensive labeling reviews, or interpreting how these new guidelines impact your specific product portfolio, we are ready to provide the necessary support.

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For more information, reach out to us.

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Should you identify these two ingredients in your formulations and would like further information on next steps, please contact us.

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For applications received on or after December 15, 2025, priority will be based on the application’s date of receipt, as attestation questions are now integrated directly into the PLA form. This process aligns with the NHP Management of Applications Policy and ensures a fair, transparent, and consistent review process while managing high application volumes. Applicants must ensure that all attestations in the PLA form are accurate, complete, and meet eligibility requirements.

Give us a call to understand more about NNHPD operations.

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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. 

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The NNHPD is contacting affected licence holders and requesting removal of these carbomers from formulations. Note that any for drug products containing these carbomer ingredients, Health Canada is also reaching out to DIN holders requesting removal of these carbomers from formulations. If you have questions or would like guidance on how this change may affect your products, please reach out to our team.

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The update aims to reduce duplicate reporting and regulatory burden. Under the revised guidance, MAHs are not required to routinely monitor the Canada Vigilance Online database or Health Product InfoWatch for Individual Case Safety Report (ICSR) obligations. However, MAHs must still report serious, unexpected adverse reactions occurring outside Canada, including those identified through foreign regulatory authority databases. If it cannot be confirmed whether the product belongs to the MAH, the report should be submitted to Health Canada with that limitation noted.

The updated guidance took effect on February 19, 2026. If you have questions or would like guidance on how this change may impact your processes, please reach out to our team.

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A FSRN is not mandatory, is not a site license and does not allow foreign sites to export directly to Canada without a licensed Canadian importer.

What’s changing?

HC is discontinuing the FSRN process to streamline site licensing and to simplify and consolidate the submission process.

Confidentiality of submitted information will be maintained with the use of direct communication between Health Canada and foreign sites as needed.

Effective February 16, 2026:

• New FSRN applications will not be accepted
• Existing FSRNs will be marked as ‘discontinued’
• GMP evidence for foreign sites must be submitted through the site license process
• References to FSRNs will be removed from guidance documents

Foreign warehouses no longer need to be listed on site licenses and the ones already listed will be removed when the license is updated as a part of an amendment or renewal. However, they must still meet all applicable GMP requirements.

Contact us if you need further understanding of this updated process and its impact on your business.

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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.

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