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.

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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.

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

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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.

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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 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.

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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.

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A significant change is that private parties can now apply directly to the Competition Tribunal to file case against a business, which may increase litigation risks. The guidelines emphasize that all environmental claims must be truthful, substantiated, and backed by “adequate and proper” testing or evidence.

The guidelines also outline six key principles for business to follow when vetting their environmental claims:

1. Truthful and not misleading: Claims should not be false or exaggerated.
2. Properly substantiated: Environmental benefits should be backed by reliable testing and evidence.
3. Specific comparative claims: When comparing products, be clear about what is being compared and the extent of the difference.
4. Avoid exaggeration: Claims should not overstate environmental benefits, considering both the literal meaning and general impression.
5. Clear and specific: Vague statements should be avoided.
6. Substantiated future claims: Any claims about future environmental benefits must be supported by a clear plan and evidence.

While the guidelines are not legally binding, they are a crucial resource for companies as they review their environmental and sustainability messaging.

If you require any assistance, have any questions or would like to understand more about how this impacts your business, please do reach out to us.

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Updates to the proposal include:

1. Lowered fees by limiting planned program enhancements.
2. Lowered the fee-setting ratio for the first 4 years.
3. Phased in fees over a 7-year period (targeting a coming into force date of December 1, 2025).
4. Removed the proposed Class III-Novel category.
5. Streamlined the annual site licensing fee categories from 5 fees to 3.

No adjustments have been made to the initial proposed fees for small businesses. The small business discounts from the initial proposal will continue to apply to the new, lower fees:

1. 100% discount for pre-market evaluation fees for the business’s first-ever NHP submission
2. 50% discounts for pre-market evaluation fees for all subsequent product submissions
3. 25% discounts for site licensing fees and the annual right-to-sell fee.

Fees have been significantly lowered based on the feedback received and the outlined program changes. Annual Site licence fees (manufacturing) have been reduced from $40,071 to $9,561 at the end of the 7 years and apply to sterile and non-sterile dosage forms. The Right to Sell (RTS) fee has been reduced from $542 to $317.

The proposal is open for consultation until April 25, 2024. We strongly advise individuals or organizations working with NHPs in Canada to promptly offer feedback and express any concerns they may have regarding the fee proposal through an online comment form.     

Please get in touch with us if you would like to know more about the proposed fee structure and how it may impact your business.

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