Key Process Changes:

Effective June 25, 2026, Health Canada has removed the requirement for applicants and licence holders to submit an FPS when filing Class II and Class III product licence applications (PLAs) and their amendments.

• This update aligns Class II and III application processes with the existing framework used for Class I applications.
• The goal is to streamline the licensing process and reduce administrative burdens while ensuring oversight remains proportionate to product risk levels.
• Under the new model, if you make changes solely to an FPS, you are no longer required to submit an amendment or formally notify Health Canada.

Ongoing Responsibilities:

While the submission process has been streamlined, the underlying quality standards have not changed:

• Stakeholders are still expected to maintain their FPS and ensure they fully comply with the current Quality of Natural Health Products Guide.
• Health Canada retains the authority to request an FPS at any time. This may occur via an Information Request Notice (IRN) during application reviews to address specific risk- or quality-related issues, such as those concerning cannabis-containing products.

This operational adjustment strictly alters the submission process and does not impact existing Natural Health Products Good Manufacturing Practices (GMP) requirements.

The post NNHPD Publishes Bulletin 11: Updates to Finished Product Specifications appeared first on Focal Point.

Key Changes in the 2025 Regulations:

The 2025 regulatory framework completely repeals and replaces the older 2012 regulations. Key updates include:

• Stricter restrictions have been placed on the manufacture, use, sale, and import of PFOS, PFOA, LC-PFCAs, HBCD, and PBDEs.
• New controls have been introduced for Dechlorane Plus (DP) and decabromodiphenyl ethane (DBDPE).
• To support businesses in transitioning to alternative ingredients, there are temporary exemptions and permit options available.
• New laboratory reporting requirements apply to DP and DBDPE, which must be submitted using Environment and Climate Change Canada’s (ECCC) Regulatory Services Platform.

Updates to the Export Control List:

Changes to the Export Control List were launched at the same time.

• Export controls have been added for PFOA, LC-PFCAs, HBCD, PBDEs, and ferbam.
• These updates help Canada fulfill its international commitments under the Rotterdam Convention regarding the trade of hazardous chemicals and pesticides.
• While Dechlorane Plus (DP) has also been added to the Export Control List, this specific listing will not be enforced until December 31, 2030.

Next Steps for Businesses:

If your company manufactures, imports, or exports any of these affected substances, you should carefully review the new requirements to determine if you have any permit or reporting obligations. Please feel free to reach out to us if you have any questions regarding this update.

The post New Toxic Substances and Export Control Regulations Now in Force appeared first on Focal Point.

Key Assessment Findings:

• The review covered 13 substances containing titanium, which include titanium dioxide, titanium tetrachloride, and various titanium alkoxides.
• These ingredients are broadly used across many industrial and consumer applications.
• The government officially concluded that none of the 13 evaluated substances meet the strict criteria to be classified as toxic under section 64 of CEPA.
• Based on current exposure levels, these substances do not enter the environment in amounts that would pose a risk to human health or the environment.
• Because no significant risks were found, the government has not proposed any new risk management measures for these materials.

Important Note on Nanomaterials:

• This specific assessment does not apply to nanoscale titanium dioxide (TiO2 nano).
• Nanoscale materials, including TiO2 nano, are scheduled to be assessed separately under the Government of Canada’s Plan of Priorities.

If you have any concerns or questions regarding this recent publication or the upcoming assessment of TiO2 nano, please contact us today.

The post Government Finalizes Assessment on Titanium-Containing Substances appeared first on Focal Point.

What Are the New Restrictions?

To manage identified concerns, the government is placing limits on how this substance can be manufactured, imported, and used. The condition mandates that Castoryl Maleate must be kept at a concentration of less than 2.5% by weight in several everyday personal care items. This concentration limit applies to the following products:

• Liquid body washes and shower gels
• Shampoos and hair conditioners
• Liquid hand soaps
• Toothpaste

Who Does This Affect?

Currently, these restrictions do not apply broadly to the entire cosmetics industry or to existing users of similar ingredients. The rules strictly apply only to the original notifier of the substance, as well as anyone to whom the substance is transferred who then becomes subject to the same conditions. It serves as an important heads-up: if your business is planning to submit notifications for this ingredient in the future, you should anticipate facing these same restrictions. If you have questions about how these rules might apply to your business, contact us today.

The post Ministerial Condition Ordered for Castor Oil, Monomaleate (INCI Name: Castoryl Maleate) appeared first on Focal Point.

However, four specific ingredients that are relevant to the cosmetics industry have been flagged for potential health concerns: Diethanolamine (DEA), lauramide DEA, cocamide DEA, and triethanolamine (TEA). The government is proposing to add these four substances to the CEPA Watch List and apply SNAc rules to them. This means that the government must be notified and must conduct an assessment before any significant new uses of these substances are introduced.

Proposed Notification Triggers:

If a business uses these substances, they will need to notify the government if their usage exceeds a 10-kg annual volume threshold combined with specific concentration limits based on the product type. The proposed concentration triggers are:

• Diethanolamine (DEA): Notification is required if used at a concentration greater than 3% in all-purpose cleaning liquids or cleaning sprays. Because DEA is already prohibited on the Cosmetic Ingredient Hotlist, there is no notification trigger for cosmetic applications.
• Lauramide DEA: Notification is required if used at a concentration greater than 2.5% in leave-on cosmetic products.
• Cocamide DEA: Notification is required if concentrations exceed 12.5% in cleaning sprays/liquids, 21% in shampoos or liquid body soaps, or 0.5% in leave-on cosmetics.
• Triethanolamine (TEA): Notification is required if concentrations exceed 4% in air fresheners, 5% in non-fluoridated toothpaste, or 1% in non-fluoridated mouthwash.

Next Steps and Call for Feedback:

A 60-day public comment period is currently open regarding these proposed SNAcs, which will officially close on August 27, 2026.

If you have any questions regarding the publication and how this may impact your business, please feel free to reach out to us.

The post Government Updates Assessment on Alkanolamines and Fatty Alkanolamides appeared first on Focal Point.

Key Proposed Changes:

• Creating a registration process for specific natural health products (NHPs).
• Implementing a more adaptable, risk-based approach to safety monitoring across all NHPs.
• Offering more flexibility regarding product labeling requirements.
• Speeding up pre-market authorization by moving certain oversight activities to the post-market phase.

Whenever Health Canada develops new regulations, they are required to complete a cost-benefit analysis (CBA). To gather data, they have released a survey intended to measure how these proposed changes might positively or negatively impact Canadian industries.

Health Canada highly encourages all stakeholders to complete the survey. Participating ensures that the final data accurately reflects the real-world impact these changes will have on individual businesses.

Your feedback is crucial because it will directly inform Health Canada’s analysis and help refine the proposal to reduce unnecessary business costs. The CBA survey for NHPs can be found here.

The post Cost Benefit Analysis Survey for Red Tape Reduction for NHPs appeared first on Focal Point.

Key updates include:

Reporting Requirements: Following confirmatory testing, Market Authorization Holders (MAHs) must assess whether nitrosamine impurities exceed the established Acceptable Intake (AI) limit and determine whether market action is required. MAHs are no longer required to notify Health Canada each time an elevated nitrosamine impurity level is detected. Notification is only required when a recall decision has been made, in accordance with the Drug, Natural Health Product and Biocide Recall guide (GUI-0039).

Risk Mitigation Expectations: While the guidance maintains a 3-year CAPA implementation timeline, Health Canada expects MAHs to implement risk mitigation measures and reduce nitrosamine levels below AI limits as soon as possible.

Safety: New contact information has been added for enquiries regarding applicable Acceptable Intake (AI) limits, including proposal for new AI limits.

Appendix 2: The decision tree has been updated to reflect the revised expectations for filing nitrosamine risk mitigation-related changes. 

If you wish to understand how these changes might affect your business, please reach out to us.

The post Health Canada updates guidance on nitrosamine impurities in medications appeared first on Focal Point.

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.

Phase 1 reporting remains mandatory. Producers of packaging, electronics and electrical equipment, and single-use plastics destined for the residential waste stream must continue to submit required data.

Additionally, ECCC has announced plans to introduce a new reporting notice for 2027-2029 and is seeking stakeholder input.

For more information, contact us.

The post Federal Plastics Registry: Reporting Deadlines Updated appeared first on Focal Point.