For more information, reach out to us.

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

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

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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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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.

Based on mandatory industry filings, the FDA’s report offers a snapshot of how prevalent these “forever chemicals” are in the supply chain:

• The agency identified 51 different PFAS currently used across 1,744 cosmetic formulations.
• These ingredients are primarily added intentionally to enhance specific product attributes, such as water resistance, durability, and texture.
• The study concentrated on the 25 most common PFAS, which account for approximately 96% of the intentional use reported.

The Safety Verdict: Still “Inconclusive”

Perhaps the most critical takeaway is that the FDA was unable to make definitive safety determinations for the majority of the chemicals identified. The agency cited significant gaps in data and a lack of publicly available toxicological research as the primary reasons for this uncertainty.

While the report noted that five specific PFAS appear to present low safety concerns, at least one was flagged for potential safety issues.

Currently, there are no federal regulations explicitly prohibiting the intentional addition of PFAS to cosmetics in the United States. However, this report signals that scrutiny is increasing. The FDA maintains its authority to take enforcement action should specific safety risks emerge from the data.

Next Steps: Moving forward, the FDA plans to increase its monitoring and surveillance efforts. The goal is to reduce PFAS prevalence across the consumer product supply chain through expanded testing and resource allocation.

The post FDA Release: The State of PFAS in Cosmetics Under MoCRA appeared first on Focal Point.

Proposed Additions (New Restrictions):

The following ingredients are being added to the Hotlist with specific usage limits:

-Basic Violet 4 (CI 42600, CAS 2390-59-2)

• Prohibited in leave-on hair products
• Restricted to a maximum of 0.4% in hair dyes and 0.2% in rinse-off hair care products

-Basic Blue 7 (CI 42595, CAS 2390-60-5)

• Prohibited in leave-on hair products
• Restricted to maximum concentrations in hair dyes (0.4%), rinse-off hair care (0.2%), nail products (0.8%), and bath products (2%).

-Polyaminopropyl Biguanide (PHMB) (CAS CAS 32289-58-0; 27083-27-8; 28757-47-3)

• Prohibited in spray or aerosol formulations due to lung risks from inhalation
• Restricted to a maximum of 0.2% in all other cosmetics

Proposed Revisions to Existing Entries:

Health Canada is proposing revisions for the following listed ingredients:

-Symphytum spp. (Comfrey)

• Prohibited: The current exception for Symphytum officinale is being removed, banning the use of this ingredient due to concerns over toxic alkaloids.

-Brucine and its salts (CAS 357-57-3; 4845-99-2)

• Prohibited: Previously restricted, this ingredient is now proposed for a total ban due to high toxicity and neurotoxic risks.

-Furocoumarins (CAS 66-97-7; 482-44-0; 642-05-7; 484-20-8; 298-81-7)

• Restricted: Intentionally adding these is not permitted.
• New Limits: Permitted only as trace contaminants in naturally occurring plant extracts, with a limit of 1 ppm (0.0001%) in all leave-on products (expanding the rule beyond just sun-tanning products).

-Imperatorin

• Removed: The specific entry for this ingredient will be removed as it will now be regulated under the broader ‘Furocoumarins’ entry.

Stakeholders are encouraged to submit comments on the changes Health Canada is proposing. The comments can be emailed or sent in writing to the Hotlist Coordinator no later than February 17, 2026. At this time, you should be evaluating your market strategy should you have products impacted by these potential updates to the Hotlist, as you will be required to comply once updates to the Hotlist are published. Should you require assistance with regulatory compliance, do not hesitate to reach out to us.

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A formal consultation will follow, during which proposed updates will be posted for a 60-day comment period. After evaluating the information and comments received, Health Canada will publish the revised Hotlist.

Proposed Additions:

Health Canada is considering adding the following ingredients (restrictions) to the Hotlist:

1. Basic Violet 4 and Basic Blue 7: Previously deemed low risk, these dyes now pose potential carcinogenic concerns due to increased use in cosmetics. 
2. Polyaminopropyl Biguanide (PHMB): Proposed restrictions include banning it in spray formulations and limiting concentrations in topical products due to respiratory and skin sensitization risks.

Proposed Revisions to the existing entries:

Prohibitions:

1. Symphytum spp., with the exception of Symphytum officinale: Health Canada is proposing a complete prohibition, including Symphytum officinale, due to newly confirmed toxic alkaloids.
2. Brucine: Currently described as restricted on the Hotlist. Due to its toxicity and absorption risk, it’s now considered for full prohibition. An expansion of the entry to Brucine and its salts is also being considered.
3. Imperatorin: Proposed for removal as a standalone entry and instead grouped under existing Furocoumarins restriction.

Restrictions:

1. Furocoumarins , except for naturally occurring in plant extracts: A revision is considered to indicate Furocoumarins are not permitted to be added to products as ingredients and would only be permitted at trace amounts when naturally occurring in plant extracts. The current maximum permitted concentration would be proposed to apply to all leave-on products, not just sun-tanning products.

Other Miscellaneous Revisions:

Existing ingredient entries may be revised to include new synonyms, Chemical Abstract Service Registry (CAS) numbers as well as other minor corrections, such as fixing typos.

Chemicals Management Plan (CMP) – Ingredients under Evaluation:

The following ingredients are being assessed under the CMP due to the potential risks associated with cosmetic usage. There might be future changes to the Hotlist if the risks are confirmed in the final assessments. These ingredients may not appear in the upcoming consultation, but sellers are advised to stay informed of the CMP process and determine which of their products could be impacted.

• Acyclic, Monocyclic, and Bicyclic Monoterpenes Group
• Alcohols Group
• Boric acid, its salts and its precursors
• Fourteen Terpene and Terpenoid Substances Group
• Gas Oils and Kerosenes with Uses in Products Available to Consumers Group
• Low Boiling Point Naphthas Group
• Monocyclic and Bicyclic Sesquiterpenes Group
• Parabens Group
• Phenylpropanoids and Aldehydes Group
• Salicylates Group
• Tricyclic Sesquiterpenes and Triterpenoids Group

To view the full notice, please visit the Health Canada website.

If you require any assistance, have any questions or would like to understand more about how this impacts your business, please do reach out to us.

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