The R-ICL is an administrative list of substances found in products regulated under the Food and Drugs Act that were in Canadian commerce between January 1, 1987, and September 13, 2001. Under CEPA, substances on the R-ICL may be added to the DSL once specific eligibility criteria have been met.

With their addition to the DSL, these 656 substances have been removed from the R-ICL and are no longer subject to the New Substances Notification Regulations. This change may reduce regulatory requirements for companies using these substances in products regulated in Canada. For more such updates, contact us.

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​While the published regulations formally introduced two new substance categories, i.e., Dechlorane Plus (DP) and decabromodiphenyl ethane (DBDPE), an update to ECCC’s Substances Search Tool reveals an increase in the listed substances, jumping from 209 CAS RNs under the 2012 Regulations to 3,218 CAS RN entries with the 2025 Regulations.

The addition of over 3,000 CAS RNs does not reflect new regulatory amendments, but rather individual chemicals that fall under broad structural definitions already regulated, particularly per- and polyfluoroalkyl substances (PFAS) such as PFOA, PFOS, and LC-PFCA precursors.

​The List is Non-Exhaustive: ECCC emphasizes that its database is a compliance guide, not an all-inclusive list. If a substance meets the structural definition outlined in the regulations, it is prohibited or restricted regardless of whether its CAS RN is explicitly cataloged.

​A screening by industry regulatory teams identified 13 cosmetic-relevant CAS RNs linked to International Nomenclature of Cosmetic Ingredients (INCI) names: including ingredients like Perfluorononyl Dimethicone, Perfluorooctylethyl Triethoxysilane, and certain fluorinated phosphates.

​Recommended Next Steps for Manufacturers and Brand Owners:

• Review all cosmetic ingredients and formulations against relevant substance groups and definitions.
• Request comprehensive ingredient disclosures and Certificates of Analysis (CoA) from the suppliers.
• Review relevant packaging, components and other materials associated with cosmetic products, as these may also be implicated.

Ensuring proactive compliance with evolving Canadian environmental standards is essential to preventing supply chain interruptions, product recalls, or import holds.

​If you have any questions regarding how this update may affect your business, do reach out to us today.

The post Canada Expands Substances Under Toxic Substances Regulations (2025) appeared first on Focal Point.

Inspectors reviewed 96 cosmetic products, including 41 imported products, through both online and in-person inspections. The findings underscore the importance of regulatory compliance:

• 35 products were found to be compliant
• 31 products required companies to commit to corrective actions
• 30 products were subject to stop distribution measures due to non-compliance

The most common deficiencies involved labeling non-compliance, while several products also failed to meet Cosmetic Notification requirements. These findings reinforce that Health Canada continues to prioritize accurate product labeling and ingredient disclosure, particularly for ingredients with specific conditions of use such as eucalyptus oil.

For cosmetic manufacturers, importers, and brand owners, this report serves as an important reminder that compliance extends beyond formulation. Companies should ensure that products meet the requirements of the Food and Drugs Act, the Cosmetic Regulations, and the Cosmetic Ingredient Hotlist, including:

• Accurate bilingual labeling and mandatory label information
• Timely submission of Cosmetic Notifications
• Compliance with ingredient-specific restrictions and cautionary statements
• Regular reviews of imported products to ensure Canadian regulatory requirements are met before market entry

Although HC notes that Compliance Verification Projects target products considered more likely to be non-compliant and therefore do not represent the overall Canadian marketplace, the results demonstrate that deficiencies can result in significant business impact, including stop-sale and stop-distribution actions. For companies operating in Canada’s cosmetics market, proactive label reviews and regulatory audits remain one of the most effective ways to reduce compliance risk.

Give us a call to ensure your product’s compliance.

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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 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.

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.

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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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​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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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.

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