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.

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.

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.

The post New Compliance Requirements for the Canadian Domestic Substance List (DSL) 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.

This guidance is intended for market authorization holders (for drugs) and licence holders (for NHPs), providing detailed information on how to comply with Canadian regulations, including the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Product Regulations.

The draft guidance clarifies the expected content, format, and submission procedures for two key types of reports:

1. Annual Summary Report (ASR): A comprehensive assessment of all known safety information for a product currently on the market.
2. Issue-Related Summary Report (IRSR): A concise, critical analysis of a specific safety or effectiveness issue, which is prepared upon request from Health Canada.

The primary goal of this update is to enhance clarity and efficiency. Key objectives include consolidating current guidance documents, converting text to plain language, addressing stakeholder questions, and updating submission processes.

A significant change in this draft is the separation of guidance for drugs and NHPs. This change is intended to better address the distinct regulatory and operational considerations for these different product lines.

Health Canada is seeking feedback from stakeholders on the proposed changes. Interested parties are encouraged to review the draft guidance and an associated draft form (“Notifying Health Canada of a significant change in what is known about the risks and benefits of a product”). Feedback can be submitted via email until the December 23, 2025, deadline.

The post Health Canada Opens Consultation on Draft Guidance for Drug and Natural Health Product Summary Reports appeared first on Focal Point.

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.

The post FDA Launches Public Dashboard for Real-Time Cosmetic Adverse Event Data appeared first on Focal Point.