The recent revisions intend to broaden the list’s applicability, increase labelling flexibility, and reduce the overall administrative burden for companies.

​Key Changes in the August 2026 Update:

• ​Transition to a Non-Exhaustive List: For NHPs and NPDs covered by List D (low-risk products used on the skin or in the mouth), the terms provided in Health Canada’s table are now treated as examples rather than a strict, exhaustive list. Companies may use other equivalent wording provided it conveys the exact same meaning and meets Health Canada’s requirements.

• ​Flexibility in Product Claims: The revised guidelines now allow the application of interchangeable terminology directly to NHP claims and the uses or indications for List D NPDs.

• ​Grammatical Adaptability: Companies have additional flexibility with grammar, such as using different verb tenses interchangeably (e.g., “ask” versus “asking”). This is permitted as long as the fundamental meaning of the sentence is not altered.

​Important Limitations to Keep in Mind:

• ​While the updated guidance provides more freedom to create consumer-friendly labels, it is not a blanket authorization to rewrite product information.
• ​Interchangeable terms must always convey the identical meaning of the authorized term and cannot be false or misleading.
• ​Some term substitutions are unidirectional. For example, the term “avoid” can be substituted with the stricter “do not,” but “do not” cannot be weakened to “avoid”.

​This regulatory update presents a valuable opportunity for NHP and NPD companies to review their existing/upcoming labels and replace overly technical jargon with more accessible language for consumers.

​If you need assistance with reviewing your label claims, please reach out to us.

The post Health Canada’s Update on Interchangeable Terms for NHPs and NPDs appeared first on Focal Point.

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.

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.

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.

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

The post New SNAc provisions added for two substances on Canada’s DSL appeared first on Focal Point.

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.

The post NNHPD clarifies review prioritization for NHP licence applications appeared first on Focal Point.

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.

The post NNHPD Updates NHPID entries due to Benzene risk appeared first on Focal Point.

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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