Scientific Regulatory & New Product Consultants Archives - Focal Point

Federal Plastics Registry: Reporting Deadlines Updated

Srishti Chaudhari — Mon, 13 Apr 2026 19:39:08 +0000

On March 14, 2026, the Government of Canada published an amended Section 46 Notice in the Canada Gazette, postponing Phase 2 and 3 reporting deadlines under the Federal Plastics Registry (FPR) for 2024-2026.

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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CARB launches 2025 Technical Assessment for Personal Fragrance Products VOC Compliance

Srishti Chaudhari — Mon, 13 Apr 2026 19:29:50 +0000

California Air Resources Board is conducting its 2025 Personal Fragrance Products Technical Assessment to evaluate the feasibility of meeting the 50% VOC limit using current and emerging technologies. All required data submissions must be provided by March 31, 2026, using CARB’s designated reporting tools for responsible parties and formulators. The assessment follows regulatory definitions of ‘fragrance’ under the Consumer Products Regulation and will support a confidential, data-driven review of industry capabilities and compliance pathways.

For more information, reach out to us.

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New Jersey enacts PFAS ban impacting cosmetics

Srishti Chaudhari — Mon, 13 Apr 2026 19:20:05 +0000

The State of New Jersey has enacted legislation prohibiting the sale of cosmetics containing intentionally added PFAS under ‘Protecting Against Forever Chemicals Act’, effective two years after the law comes into force. Cosmetic products with only technically unavoidable trace amounts of PFAS arising form impurities, manufacturing, storage, or packaging will be considered to be compliant. The law introduces significant obligations for cosmetic businesses, including reformulation requirements for affected products, with enforcement led by the New Jersey Department of Environmental Protection.

To ensure your products remain compliant, please reach out to us.

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FDA Issues Final rule on Nation Drug Code (NDC) format

Srishti Chaudhari — Mon, 13 Apr 2026 19:02:07 +0000

The US FDA has issued a final rule adopting a uniform 12-digit format for the NDC, which uniquely identifies drugs marketed in the US. Currently, FDA-assigned NDCs are 10 digits and may appear in several different formats. The rule will take effect on March 7, 2033. At that time, the FDA will begin assigning new 12-digit NDCs to the standardized format. This update applies only to the FDA-assigned NDCs and does not affect other NDC formats used outside the FDA, such as the HIPAA 11-digit format used for reimbursement.

If you have questions or would like guidance on how this change may impact your registrations, please reach out to our team.

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Health Canada updates Acceptable Intake limits for Nitrosamine impurities

Srishti Chaudhari — Mon, 13 Apr 2026 18:36:15 +0000

Health Canada has updated its list of established Acceptable Intake (AI) limits for nitrosamine impurities (Appendix 1), now available online. The update includes the addition of N-nitroso-dabigatran etexilate imide as a new impurity with a corresponding AI limit, along with revised limits for seven existing nitrosamines, including N-nitroso-folic acid, N-nitroso-vancomycin, and N-nitroso-mglumine – the latter significantly reduced from 1,500 ng/day to 100 ng/day. The updated list can be filtered by date to identify recent changes. Stakeholders are encouraged to consult the latest guidance on nitrosamine impurities in medications to ensure ongoing compliance.

For more information, reach out to us.

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New SNAc provisions added for two substances on Canada’s DSL

Srishti Chaudhari — Mon, 13 Apr 2026 18:18:38 +0000

ECCC and Health Canada have announced updates to the DSL in Canada Gazette, Part I, introducing Significant New Activity (SNAc) provisions for two substances used in consumer products, including cosmetics: 2-ethylhexyl 2-ethylhexanoate and Cyclohexylamine. The new provisions require companies to submit data for new activities involving these substances at quantities as low as 0.1% in products, with data requirements that exceed those outlined in Schedule 4 of the New Substances Notification (NSN) Regulations. Companies are advised to review their current and planned uses of these substances to ensure the necessary data are available to meet the SNAc requirements.

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

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NNHPD clarifies review prioritization for NHP licence applications

Srishti Chaudhari — Mon, 13 Apr 2026 18:11:48 +0000

The NNHPD is currently experiencing a high volume of NHP licence applications and has formalized how applications will be assigned for review under its workload management approach. Applications will now be reviewed on when prioritization was requested instead of the original submission date. For applications submitted before December 15, 2025, review priority will be determined by the date the Workload Management Form was submitted.

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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Updates to the Cosmetic Notification Form

Sagarika Sharma — Mon, 06 Apr 2026 20:52:24 +0000

Health Canada recently announced significant updates to the Cosmetic Notification Form (CNF) and the Guide for Cosmetic Notifications. These changes introduce a ‘flexible approach’ to how companies disclose fragrance allergens, balancing consumer safety with a streamlined notification process.

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.

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NNHPD Updates NHPID entries due to Benzene risk

Srishti Chaudhari — Thu, 02 Apr 2026 20:34:20 +0000

Following alerts from the US FDA regarding benzene contamination, the NNHPD has updated several entries in the NHPID. Benzene is a Class 1 solvent with unacceptable toxicity and must not be used in health product manufacturing. Key changes include the removal of carbomer grades 934, 934P, 941, and 1342 as well as the generic ‘carbomer’ entry, which will now require identification of specific grades. This aligns with proposals from the US Pharmacopeia and National Formulary to omit these carbomer monographs.

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.

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Health Canada updates guidance on Adverse Reaction Reporting

Srishti Chaudhari — Thu, 02 Apr 2026 20:24:09 +0000

Health Canada has issued a notice clarifying adverse reaction reporting expectations for Market Authorization Holders (MAHs) of drugs (including pharmaceuticals, biologics and radiopharmaceuticals) and Natural Health Products (NHPs). The notice replaces Section 4.3 of the Reporting Adverse Reactions to Marketed Health products – Guidance Document for Industry (2018) and the 2020 Notice to Industry.

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.

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