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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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.

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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.

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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 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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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.

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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.

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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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