For more information, reach out to us.

The post CARB launches 2025 Technical Assessment for Personal Fragrance Products VOC Compliance appeared first on Focal Point.

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

The post FDA Issues Final rule on Nation Drug Code (NDC) format 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The post New FDA Draft Guidance: Records Access for Cosmetics Under MoCRA appeared first on Focal Point.

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.

This release is a key step in implementing the Modernization of Cosmetics Regulation Act (MoCRA), aimed at providing the industry with clarity regarding the FDA’s new mandatory recall authority.

What the Guidance Covers

The draft document outlines the specifics of how and when the FDA will exercise its power to force a recall. Key areas of focus include:

Decision Criteria: The specific criteria the FDA will use to determine if a mandatory recall is necessary.

The Process: A step-by-step look at the procedure the FDA will follow when implementing a mandatory recall.

Industry Expectations: Clear guidelines on what is expected from companies regarding compliance with these orders.

Call to Action

Industry stakeholders are encouraged to review the document to understand their new obligations. The draft guidance is currently open for public comment.

Deadline: You must submit your comments by February 17.

The post FDA Releases Draft Guidance on Mandatory Cosmetics Recalls under MoCRA appeared first on Focal Point.

Key Deadline:

Reporting Window: Currently Open

Submission Deadline: April 1, 2026

New Requirement: Personal Care Products

For the first time, producers of plastic containers for household cleaning and personal care products must submit annual reports on recycled content. This reporting requirement is triggered because the statutory minimum for these categories took effect in 2025. You must now report on the resin sold into Washington during the 2025 calendar year to demonstrate compliance with this new standard.

Recycled Content Targets (PCR):

Based on the compliance timeline, personal care producers should be aware of the current active requirement and the future increases mandated by law:

Current Requirement (2025): Your packaging must meet a 15% minimum PCR content standard.

Future Increase (2028): The requirement will jump to 25%.

Long-Term Goal (2031): The standard increases significantly to 50%.

Action Required:

Register: Log in to the Waste Reduction Portal.

Report: Submit your data for the 2025 calendar year, ensuring you account for the 15% PCR requirement if you are in the personal care sector.

Verify: Ensure that even if you are a de minimis producer, you complete the annual registration as required by law.

Failure to register and report by April 1, 2026, may result in non-compliance penalties. We recommend gathering your 2025 resin weight and supplier certifications immediately to meet the deadline.

The post Washington State Update: Mandatory PCR Reporting Begins for Personal Care Products appeared first on Focal Point.

What’s New in this Update?

For the first time, the list includes published recycling rates by CMC, a requirement under PRC section 42061(b).

Why It Matters:

• Defines Compliance: The list sets CalRecycle’s official determinations on which material categories meet the criteria for recyclability and compostability.
• Labeling Impact: These determinations directly influence your eligibility to use “recyclable” or “compostable” labels pursuant to PRC sections 42061(c) and (d).

The updated CMC list and guidance on categorization on the CalRecycle SB 54 Covered Material Categories can be found on the webpage. It’s time to check your product classifications against the new rates. Please contact us if you have any questions regarding this update.

The post SB 54 Update: CalRecycle Releases Updated CMC List & First-Ever Recycling Rates 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.

CARB is currently evaluating whether it is feasible for the industry to meet the upcoming 50% Volatile Organic Compound (VOC) standard using current or emerging technologies. As part of this evaluation, new reporting requirements are now in effect.

Deadline: All data for the 2025 Personal Fragrance Products Technical Assessment must be submitted to CARB by March 31, 2026.

What is Required:

Responsible Parties need to complete two main tasks:

• Submit the Data: You must use the interactive Personal Fragrance Products Reporting Tool (PFP-RT). This is a macro-enabled Excel workbook (available for both Windows and Mac) where you will list products, ingredients, and responsible parties.

Submit a Written Report: In addition to the raw data, you are required to submit a written update regarding your R&D efforts. This report should detail the work being done to meet the future 50% VOC standard.

Streamlined Process for Formulators:

To make reporting easier, CARB has changed how they handle trade secrets and third-party formulators. You do not need to contact your formulators for their data. Instead, once you submit your report (PFP-RT) listing your Product Formulators, CARB staff will contact them directly. CARB will send them a separate tool (PFP-RTF) to collect the necessary formulation data, ensuring confidentiality is maintained without you having to act as the middlemen.

This assessment is a critical step toward the January 1, 2031, regulations. By that date, non-aerosol fragrance products (with 10% or less fragrance) and aerosol products will be required to meet the strict 50% VOC limit. This assessment is CARB’s way of checking the industry’s pulse to see if the goal is achievable.

Next Steps: Download the reporting tools and review the definition of ‘Fragrance’ to ensure you are reporting the correct ingredients. If you require assistance in understanding the regulations, please contact us. 

The post CARB Launches 2025 Personal Fragrance Technical Assessment appeared first on Focal Point.