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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What is Changing?

The update focuses on Significant New Activity (SNAc) provisions. These are risk management tools used when a substance, already on the DSL, is used in a new quantity, concentration, or circumstance that could change its impact on human health or the environment.

• SNAc requirements have been applied to 54 existing substances and modified for 161 others.
• Part 2 of the DSL (Chemicals and Polymers) is now split into Division 1 (individual substances) and Division 2 (group of substances).
• A new Schedule 1 has been added to standardize information required for SNAc Notifications (SNAN).

Why This Matters to Your Business?

The most critical takeaway is the potential for instant non-compliance. Many of these changes specifically target consumer products and cosmetics, and the triggers for reporting are much lower than previous standards.

• Low concentration triggers: Some substances now have concentration triggers as low as 0.1% or 1%.
• Low volume triggers: Compliance requirements may now kick in at just 10 kg per year. This is significantly lower than standard New Substances Notification (NSN) triggers.
• Pre-emptive reporting: Companies are required to submit a Significant New Activity Notice (SNAN) at least 90 days before the day on which the significant new activity begins. If your current operations exceed these new thresholds, you may need to act immediately.

Recommended Next Steps:

• Review your current raw materials and finished product formulations against the updated DSL list.
• Check if any of your ingredients fall under the 223 impacted substances.
• Determine if your annual use exceeds the new concentration or volume thresholds. 
• File a SNAN for any significant new activity.

If you need assistance reviewing your formulations or determining your compliance status under these new requirements, please contact us. We are here to help you navigate these changes and ensure your products remain compliant.

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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.

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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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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.

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This is a significant move that aligns NHP oversight with other regulated health product sectors like drugs and medical devices. The DHPID will be a public resource offering detailed inspection information, including dates, compliance ratings, key observations, and regulatory actions. This increased transparency aims to benefit stakeholders and will provide valuable insights into regulatory compliance.

Our team is ready to help ensure your facility’s quality systems are not just compliant, but ‘inspection-ready’ for Health Canada.

The post Health Canada Boosts NHP Transparency: GMP Inspection Results Going Public! appeared first on Focal Point.

This new, user-friendly dashboard is an interactive tool that allows the public, industry, and researchers to query and download real-time data on adverse events related to cosmetic products. According to the FDA, the reports are updated daily to include the most recent submissions.

The dashboard contains data from two key sources:

• Mandatory Reports: Serious adverse event reports submitted by cosmetic companies (“responsible persons”) as required by MoCRA.
• Voluntary Reports: Reports submitted to the FDA by consumers, healthcare professionals, and others.

Impact on the Industry:

This public-facing tool marks a new era of transparency for cosmetic product safety. It provides a direct view into the safety data being collected by the agency and will be a critical resource for post-market surveillance. Companies can monitor trends related to their own products, ingredients, and entire product categories.

We encourage all industry professionals, particularly those in regulatory, quality, and safety roles, to explore this new dashboard to understand its capabilities and implications for your business.

Please contact us if you require assistance with your adverse event reporting procedures or overall MoCRA compliance strategy.

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-Ban the sale of plastic glitter in personal care products by January 1, 2030.

In his veto message, Governor Newsom explained that while he supports the goal of protecting California’s waterways from microplastics, he was not supportive of the approach this bill takes. He expressed concerns that the bill’s ban on specific ingredients, such as glitter, may incidentally result in a prohibition on biodegradable or natural alternatives.

What this means for the Industry?
This veto means the specific bans and compliance deadlines outlined in AB 823 will not become law at this time. The immediate pressure to reformulate away from plastic glitter based on this bill has been lifted. However, this topic remains a high priority issue for legislators and consumers. Our team will continue to monitor any furfure legislative efforts to regulate microplastics in cosmetics.

The post California Governor Vetoes Bill to Ban Plastic Glitter (AB 823) appeared first on Focal Point.

Bemotrizinol, also known as BEMT or Tinosorb S, is a broad spectrum, photostable UV filter that has been widely used in Europe and Asia for years. It protects against both UVA and UBV rays, which are responsible for sunburn, premature aging, and skin cancer. Unlike some older UV filters, bemotrizinol does not degrade in sunlight, meaning it remains effective for longer. It is also more fat-soluble, which helps it to provide better broad-spectrum protection.

The approval of bemotrizinol would give sunscreen manufacturers a new, effective tool to create safer and more effective products. It could also lead to more cosmetically elegant formulas that are less likely to leave a white cast on the skin, which would be a major benefit for people with darker skin tones.

If the FDA approves bemetrizinol, it could still be several months or even years before it is available in sunscreens on the U.S. market. This is due to the time it takes for manufacturers to formulate new products. Conduct stability testing and get them on store shelves. However, the potential approval of this new ingredient is a significant step forward for sun protection in the United States.

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