Here is a quick breakdown of what you need to know to stay compliant:

1.The ‘Flexible Approach’ for CNF Submissions

In most cases, companies are no longer required to provide the exact concentration or concentration range on the CNF for fragrance allergens. However, there is a major exception:

• If a fragrance allergen has a specific concentration-related condition listed on the Cosmetic Ingredient Hotlist, providing the exact concentration or range remains mandatory.

2. Reminder: Mandatory Labeling Requirements (April 12, 2026)

Starting April 12, 2026, fragrance allergens must be disclosed within the ingredient list on cosmetic labels if they exceed the following thresholds:

• 0.001% for leave-on products
• 0.01% for rinse-off products

This change is designed to help consumers with known allergies make informed, safe purchasing decisions.

3. Changes to the Cosmetic Notification Form (Section 5)

To accommodate these updates, Section 5 of the CNF has been revised:

• The ‘Fragrance Allergen’ checkbox has been renamed to ‘Fragrance allergen present above the disclosure threshold’.
• You must enter one fragrance allergen per ingredient line and check this box if the concentration exceeds the limits mentioned above.
• While the flexible approach allows for less details on the CNF, Health Canada still encourages manufacturers and importers to provide exact concentrations when possible.

Navigating these new regulatory thresholds can be complex. Contact us if you need assistance submitting CNFs or performing label reviews to stay compliant. 

The post Updates to the Cosmetic Notification Form 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.

The post Health Canada updates guidance on Adverse Reaction Reporting appeared first on Focal Point.

In addition, as of April 01, 2026, all Class II, III and IV medical device applications and amendments must be submitted electronically through the Regulatory Enrolment Process via the Common Electronic Submissions Gateway. Email submissions will no longer be accepted.

Health Canada has also implemented a new Terms and Conditions framework for device licenses, strengthening post-market oversight and adopted the International Medical Device Regulators Forum Table of Contents format to align with global standards. These changes aim to streamline submissions and improve regulatory efficiency.

If you need additional information or guidance on navigating these new processes, please reach out to us.

The post Health Canada modernizes Medical Device Submission Requirements appeared first on Focal Point.

What is Changing?

The update focuses on Significant New Activity (SNAc) provisions. These are risk management tools used when a substance, already on the DSL, is used in a new quantity, concentration, or circumstance that could change its impact on human health or the environment.

• SNAc requirements have been applied to 54 existing substances and modified for 161 others.
• Part 2 of the DSL (Chemicals and Polymers) is now split into Division 1 (individual substances) and Division 2 (group of substances).
• A new Schedule 1 has been added to standardize information required for SNAc Notifications (SNAN).

Why This Matters to Your Business?

The most critical takeaway is the potential for instant non-compliance. Many of these changes specifically target consumer products and cosmetics, and the triggers for reporting are much lower than previous standards.

• Low concentration triggers: Some substances now have concentration triggers as low as 0.1% or 1%.
• Low volume triggers: Compliance requirements may now kick in at just 10 kg per year. This is significantly lower than standard New Substances Notification (NSN) triggers.
• Pre-emptive reporting: Companies are required to submit a Significant New Activity Notice (SNAN) at least 90 days before the day on which the significant new activity begins. If your current operations exceed these new thresholds, you may need to act immediately.

Recommended Next Steps:

• Review your current raw materials and finished product formulations against the updated DSL list.
• Check if any of your ingredients fall under the 223 impacted substances.
• Determine if your annual use exceeds the new concentration or volume thresholds. 
• File a SNAN for any significant new activity.

If you need assistance reviewing your formulations or determining your compliance status under these new requirements, please contact us. We are here to help you navigate these changes and ensure your products remain compliant.

The post New Compliance Requirements for the Canadian Domestic Substance List (DSL) appeared first on Focal Point.

A FSRN is not mandatory, is not a site license and does not allow foreign sites to export directly to Canada without a licensed Canadian importer.

What’s changing?

HC is discontinuing the FSRN process to streamline site licensing and to simplify and consolidate the submission process.

Confidentiality of submitted information will be maintained with the use of direct communication between Health Canada and foreign sites as needed.

Effective February 16, 2026:

• New FSRN applications will not be accepted
• Existing FSRNs will be marked as ‘discontinued’
• GMP evidence for foreign sites must be submitted through the site license process
• References to FSRNs will be removed from guidance documents

Foreign warehouses no longer need to be listed on site licenses and the ones already listed will be removed when the license is updated as a part of an amendment or renewal. However, they must still meet all applicable GMP requirements.

Contact us if you need further understanding of this updated process and its impact on your business.

The post Health Canada ends FSRN Process appeared first on Focal Point.

Purpose and Scope:

The primary goal of this draft is to provide clarity to the industry regarding the FDA’s authority to access and copy records related to cosmetic products. Presented in a Questions-and-Answer format, the guidance specifically addresses three general topic areas:

• Section 605: Authority regarding Adverse Event Reports
• Section 610: Authority regarding Serious Adverse Health Consequences or Death (SAHCOD)
• Confidentiality and Refusal: Procedures regarding the protection of sensitive information and the refusal of access.

Regulatory Status:

Industry professionals are reminded that, like all FDA guidance documents, this draft represents the Agency’s ‘current thinking’. It does not establish legally enforceable responsibilities unless specific regulatory or statutory requirements are cited. Recommendations marked with the word should suggest practices rather than mandatory requirements.

Public Comment Period:

Stakeholders are encouraged to review the draft and submit comments

• Target Publication Date: January 22
• Where to Comment: www.regulations.gov
• Docket Number: FDA-2025-D-2243

The post New FDA Draft Guidance: Records Access for Cosmetics Under MoCRA appeared first on Focal Point.

Key Provisions of the Bill

The Core Ban: The bill prohibits animal testing specifically for cosmetics.

Effective Date: The proposed ban is set to take effect on December 31, 2026, giving the industry a transition period to adapt to new compliance standards.

Important Exceptions: To accommodate global trade requirements and multi-use chemical regulations, SB 1005 outlines specific exceptions where animal testing would still be permitted:

• Foreign Mandates: Testing that is specifically mandated by foreign regulatory authorities remains an exception.
• Non-Cosmetic Ingredients: Testing performed on ingredients that are intended for use in non-cosmetic products is excluded from the ban.

What This Means for the Industry This move by Arizona mirrors a growing trend across the country as more states move toward cruelty-free legislative frameworks. Brands selling in Arizona should begin reviewing their supply chains and testing protocols in anticipation of the 2026 deadline. 

The post Arizona Introduces SB 1005 to Ban Cosmetic Animal Testing appeared first on Focal Point.

The Scope: What is regulated?

The regulation applies to nail coatings and artificial nails that contain methyl methacrylate (MMA) at concentrations greater than 1,000 parts per million (ppm).

This applies to MMA present as:

• An intentionally added ingredient.
• A residual.
• A contaminant.

Crucial Cut-off: The regulation specifically captures products manufactured on or after April 1, 2026, and sold in California.

Who Must Comply?

The onus is on domestic and foreign manufacturers selling affected products in California. If you are a Canadian manufacturer exporting to the Californian market, you fall under this scope.

Critical Compliance Timeline:

The DTSC has outlined a strict reporting schedule for 2026. Missing these dates can result in non-compliance.

April 1, 2026: The regulation becomes effective.

June 1, 2026 (The PPN Deadline): Manufacturers must submit a Priority Product Notification (PPN) to the DTSC. This notification must list all products sold in California containing MMA > 1,000 ppm.

September 28, 2026 (The Action Deadline): After submitting the PPN, manufacturers must submit one of the following via the CalSAFER portal:

• Chemical Removal Intent/Confirmation Notification
• Product Removal Intent/Confirmation Notification
• Product-Chemical Replacement Intent/Confirmation Notification
• Preliminary Alternatives Analysis Report (or alternate reporting options)

Why is this happening?

The DTSC has identified MMA exposure through normal nail product use as a potential cause of significant adverse impacts, particularly for sensitive subpopulations such as nail salon workers and pregnant people.

Next Steps for Manufacturers:

Audit Formulations: Immediately review product formulations and testing data to determine if MMA levels exceed the 1,000 ppm threshold.

Prepare for PPN: If you exceed the threshold, begin preparing your Priority Product Notification now to ensure submission before the June 1st deadline.

Decide on a Strategy: Determine whether you will reformulate (remove/replace MMA), remove the product from the California market, or conduct an Alternatives Analysis. If you would like us to review your formulations to ensure they comply with the regulations, contact us now.

The post California DTSC Finalizes MMA Regulation for Nail Products appeared first on Focal Point.

The Numbers at a Glance

For FY 2026, the FDA has adjusted fees upward, reflecting an approximate 4.9% increase compared to the previous fiscal year.

Tier 1:

FY2026 – $587,529

(FY2025 was $559,777)

Tier 2:

FY2026 – $117,505 (FY2025 was $111,955)

The post FDA Announces Fiscal Year 2026 OMOR Fee Rates: Costs to Increase appeared first on Focal Point.