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.

The post 174 Substances Added to the Non-Domestic Substances List (NDSL) appeared first on Focal Point.

​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.

The post NNHPD Launches Dedicated Landing Page for Non-prescription Drugs appeared first on Focal Point.

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.

The post Health Canada ends FSRN Process appeared first on Focal Point.

Key Deadline:

Reporting Window: Currently Open

Submission Deadline: April 1, 2026

New Requirement: Personal Care Products

For the first time, producers of plastic containers for household cleaning and personal care products must submit annual reports on recycled content. This reporting requirement is triggered because the statutory minimum for these categories took effect in 2025. You must now report on the resin sold into Washington during the 2025 calendar year to demonstrate compliance with this new standard.

Recycled Content Targets (PCR):

Based on the compliance timeline, personal care producers should be aware of the current active requirement and the future increases mandated by law:

Current Requirement (2025): Your packaging must meet a 15% minimum PCR content standard.

Future Increase (2028): The requirement will jump to 25%.

Long-Term Goal (2031): The standard increases significantly to 50%.

Action Required:

Register: Log in to the Waste Reduction Portal.

Report: Submit your data for the 2025 calendar year, ensuring you account for the 15% PCR requirement if you are in the personal care sector.

Verify: Ensure that even if you are a de minimis producer, you complete the annual registration as required by law.

Failure to register and report by April 1, 2026, may result in non-compliance penalties. We recommend gathering your 2025 resin weight and supplier certifications immediately to meet the deadline.

The post Washington State Update: Mandatory PCR Reporting Begins for Personal Care Products appeared first on Focal Point.

Key proposed changes include:

• New restrictions on Basic Violet 4 and Basic Blue 7 – Prohibited in leave-on haor products; limited concentrations in other uses

• Polyaminopropyl Biguanide (PHMB) – Prohibited in spray/aerosol products; capped at 0.2% in other cosmetics

• Full bans proposed for Symphytum spp. (Comfrey) and Brucine and its salts

• Stricter limits on Furocoumarins (1 ppm in leave-on products); Imperatoin to be regulated under this broader entry

Comments must be submitted by February 17, 2026. Companies should assess product impact and prepare for compliance.

Contact us if you require regulatory support.

The post Reminder – Consultation Deadline for Hotlist Updates appeared first on Focal Point.

This proposal highlights the effectiveness of the OTC Monograph Order Request (OMOR) pathway. Initiated by a request from DSM Nutritional Products LLC, the FDA is proposing the inclusions of bemotrizinol at concentrations up to 6% without requiring a full New Drug Application. The FDA’s review confirmed that the ingredient meets high safety standards, offering broad spectrum (UVA/UVB) protection with low skin absorption and a favorable tolerability profile.

The FDA is currently inviting public feedback on this proposal via the OTC Monograph@FDA portal. If the agency ultimately concludes that bemotrizinol is generally recognized as safe and effective (GRASE), it will issue a final order formally adding the ingredient to he OTC Monograph M020.

The post 📢 FDA Modernization in Action: The Bemotrizinol Proposal & The Future of OTC Monograph Reform appeared first on Focal Point.

This proposed legislation targets the environmental impact of microplastics by regulating personal care products.

Key Compliance Dates:

• December 31, 2029 (Effective Date): By this date, no person shall manufacture or accept for sale a personal care product that contains nonbiodegradable plastic glitter.
• December 31, 2030 (Sell-Through Date): The bill allows for a one-year grace period for retail. Until this date, vendors may continue to sell existing stock of products containing the banned glitter, provided the stock was acquired and transported into the State before the December 31, 2029, deadline.

While the effective date offers a significant runway for transition, this bill signals a continued regulatory trend across the country toward the elimination of nonbiodegradable plastics in consumer goods.

Our team will continue to monitor the progress of HB 4175 to ensure future compliance.

The post Illinois Proposed Ban on Nonbiodegradable Plastic Glitter appeared first on Focal Point.

Effective January 1, 2026, non-compliant products found in Washington State will be in violation of state law, regardless of when they were purchased or manufactured.

All stakeholders with physical inventory should take the following steps:

–Audit ‘Existing Inventory’ (Acquired Before Jan. 1, 2025): If you are holding stock acquired prior to 2025 that contains restricted substances:

• Through Dec. 31, 2025: You may continue to sell these items or use them in professional services.
• Starting Jan. 1, 2026: All sales and usage must cease. You must remove these products from shelves and service areas immediately.

–Audit ‘New Inventory’ (Acquired On/After Jan. 1, 2025): Any non-compliant inventory acquired during the 2025 calendar year is already in violation. If any such stock is identified, it must be removed from sale immediately to mitigate enforcement action.

Disposition of Unsold Inventory:

The Department of Ecology has provided specific guidance for handling non-compliant goods starting January 1, 2026:

• Redistribution: Companies are permitted to move this inventory to retail locations or distribution centers outside of Washington State, provided those jurisdictions do not have similar prohibitions.
• Disposal: If redistribution is not possible, the product must be disposed of according to local waste management regulations.

Critical Warning: Do Not Donate! Companies are prohibited from donating these non-compliant cosmetic products.

If you require assistance identifying restricted chemical classes or determining compliance of specific formulations, please contact us.

The post Washington State TFCA Sell-Through Period Expires December 31 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.

Key updates:

Separate submissions: Amendment applications must be filed separately from renewal applications. Including an amendment in a renewal will not be accepted. A key reminder that companies are not authorized to conduct any activities related to an amendment until Health Canada has officially approved and amended the Site Licence.

Timelines:

• New applications, Renewals and Amendments: Service standards are 35, 65, or 95 business days, depending on the type of evidence and number of sites.
• Notifications: Processed within 15 business days.
• Health Canada recommends submitting amendment and notification applications at least 65 business days before your SL expires OR after the expiry of the SL for which a renewal has been received.

Amendments: Required for significant changes such as adding or removing new activities, sites, categories, changing addresses, and merging. 

Notifications: Required in case of change to company name, Quality Assurance Person (QAP), site equipment, procedures, or mailing address (where no licensable activities are conducted).

Supporting documents: In addition to the documents listed in the webSLA form, specific supporting documents are required for amendment and notification, as detailed in Bulletin 8.

By following these updated guidelines, you can help ensure faster approval of your site licence amendments and notifications.

Reach out to us if you need help with compiling Site Licence applications.

The post Updates on Amendment and Notification Applications for Site Licences appeared first on Focal Point.