• Claims must remain cosmetic – In Canada, cosmetic claims are regulated under the Food and Drugs Act and the Cosmetic Regulations. While products may claim to moisturize, improve the appearance of skin or enhance radiance, claims suggesting tissue regeneration, stimulation of collagen production or cellular repair may imply a therapeutic purpose and could shift a product into the drug and natural heath product category, depending on the overall presentation.

• Scientific evidence matters – Many marketing materials reference in-vitro studies or clinical research involving injectable PDRN. Companies should ensure that any efficacy claims made for topical cosmetic products are supported by evidence relevant to the finished formulation and intended route of application. Extrapolating results from injectable products to cosmetics may not be considered appropriate substantiation.

• Ingredient sourcing and transparency – Since PDRN is commonly derived from salmon DNA, manufacturers should maintain appropriate documentation regarding ingredient identity, purity, manufacturing controls and supplier quality.

• Cross-border compliance – PDRN products originating from international markets may require claim adjustments before entering the Canadian market. Marketing language that is acceptable in one jurisdiction may trigger different regulatory classifications elsewhere, particularly when references are made to regeneration or DNA repair.

PDRN represents both an exciting innovation and a reminder that emerging ingredients require careful regulatory review. Companies introducing these products should evaluate ingredient documentation, product classification, claim substantiation, and advertising language early in the development process to support compliance while minimizing regulatory risk. If you wish to have your cosmetic ingredients or claims reviewed prior to market entry, please contact us.

The post PDRN – The New Popular Cosmetic Ingredient appeared first on Focal Point.

Upcoming Formaldehyde Releaser Restrictions:

On August 28, 2025, Washington became the first state to enact a comprehensive ban on formaldehyde-releasing chemicals in cosmetics. These new restrictions specifically target 25 intentionally added formaldehyde releasers, as well as their CAS RN aliases.

By defining an “intentionally added” chemical as one that serves a specific intended function within a product or ingredient, the state restricts any chemical that releases formaldehyde when the formaldehyde itself serves a functional purpose.

This mandate impacts cosmetics manufacturers, distributors, retailers, and cosmetology businesses operating within Washington state. The rules apply universally to all cosmetic products, whether they are used in professional services, sold online, or purchased in physical retail stores.

Important Upcoming Deadlines:

• January 1, 2027: The restrictions on formaldehyde releasers will officially go into effect.
• December 31, 2027: In-state retailers are required to completely sell through their existing stock by this final date.

A Reminder on Formaldehyde and Methylene Glycol:

As a quick reminder, restrictions targeting formaldehyde and methylene glycol have already been in effect since January 1, 2025. The allowed sell-through period for these specific chemicals concluded on December 31, 2025.

As a result, products containing formaldehyde or methylene glycol, which are frequently found in hair straightening solutions like keratin treatments, can no longer legally be kept on store shelves or used in salons across Washington. If your business manufactures, distributes, or sells cosmetics containing these ingredients, you must halt operations involving those items immediately and review state compliance guidance.

How to Prepare for the 2027 Restrictions:

To ensure readiness for the upcoming changes, businesses should take the following proactive steps:

• Carefully review all product labels and verify ingredients against the state’s restricted chemicals list.
• Conduct thorough research into product ingredients, as formaldehyde releasers used as preservatives may not always be explicitly listed on product packaging.
• Consult the updated TFCA Guide for strategies to determine if your products contain hidden formaldehyde releasers.

Updated TFCA Guide Now Available:

Because any business manufacturing, distributing, selling, or using cosmetics in Washington must comply with the TFCA, the state has recently updated its official guide for industry and sellers.

The revised guide now fully incorporates the new formaldehyde releaser restrictions. It is a critical resource that explains exactly which chemicals are restricted and when the deadlines hit. The guide is designed specifically to help you evaluate your supply chain, identify restricted chemicals in your inventory, and understand the necessary next steps to achieve full compliance. If you need help understanding these new requirements, contact us today.

The post Spring 2026 Update: Washington’s Toxic-Free Cosmetics Act (TFCA) appeared first on Focal Point.

In granting the injunction, the court determined that the plaintiffs are likely to succeed on their claims that SB 343 infringes on First Amendment commercial speech rights and fails to offer businesses clear, actionable guidance for compliance.

As background, SB 343 restricts the use of “chasing arrows” symbols and recyclability marketing unless packaging meets strict California-specific metrics – such as being collected and processed by facilities serving at least 60% of the state’s population and using non-interfering inks or adhesives. Because these standards conflict with requirements in many other states, companies selling products nationally faced hefty compliance costs, separate inventory requirements, and complete packaging redesigns.

This ruling effectively pauses the law’s upcoming October 4, 2026 compliance deadline and removes the immediate threat of state enforcement while litigation continues. However, it is crucial to remember that this is a temporary hold rather than a final ruling; California may appeal or ultimately win the case.

Additionally, standard false advertising and consumer protection laws remain in full effect, meaning all environmental and recyclability claims must still be truthful, fully documented, and substantiated. Reach out to us if you have any questions regarding this update.

The post Federal Court Temporarily Blocks CA SB 343 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.

The post Key Takeaways from Health Canada’s Cosmetic Compliance Verification Project 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.

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.