Introduction: A New Era in U.S. Cosmetic Regulation
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most sweeping update to U.S. cosmetic legislation in decades. Among its many new requirements are mandates for standardized asbestos testing in talc and fragrance allergen disclosure.
These mandates are not optional extras. Once finalized, failure to comply may render a product adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), exposing firms to regulatory enforcement, market bans, recalls, and reputational risk.
Given the lead time needed for analytical capability, supply chain audits, label updates, and compliance verification, now is the time for cosmetic companies to begin serious preparation.
The Asbestos-in-Talc Rule: Where We Stand & What It Will Require
Mandated Testing of Talc for Asbestos
Under Section 3505 of MoCRA, FDA is required to issue a rule establishing standardized testing methods to detect and identify asbestos in talc and talc-containing cosmetic products.
On December 27, 2024, FDA published a proposed rule titled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.”
The comment period closed at the end of March 2025. If the Final Rule proceeds as expected, the following requirements will be necessary for compliance.
- Testing of a representative sample of each batch or lot of talc-containing cosmetic products, or of each batch/lot of the talc ingredient used.
- Use of both Polarized Light Microscopy (PLM, with dispersion staining) and Transmission Electron Microscopy + EDS / SAED (TEM/EDS/SAED) for detection and identification.
- As an alternative (or supplement), reliance on a supplier’s certificate-of-analysis (CoA) is allowed, but only if the supplier is fully qualified and has used the same dual-methods (PLM + TEM) and the manufacturer verifies that reliability (initial and periodic re-verification).
- Detailed recordkeeping and traceability requirements to document that each batch was tested (or covered by qualified supplier CoAs), with retention of supporting data.
- Any presence of asbestos (at any detectable level by these methods) would render the product or talc adulterated under the FD&C Act.
- Non-compliance with testing or recordkeeping would also render the product adulterated.
FDA indicates that combining PLM (for larger sample volume) with TEM (for higher sensitivity) gives the best balance of sensitivity and specificity.
Further, the rule would adopt a broad mineralogical definition of asbestos to include classic commercial asbestos minerals (amosite, chrysotile, crocidolite, tremolite, actinolite, anthophyllite) as well as as-yet unregulated amphibole asbestiform minerals (e.g., winchite, richterite) and “other amphibole minerals in the asbestiform habit.”
Notably, industry will need to adjust: existing test practice in many labs may rely solely on PLM or modified protocols; the dual-method requirement likely demands method development and qualification.
After finalization, currently estimated to occur in March 2026, there will likely be an implementation period (typically 6–12 months) before enforcement begins, allowing the industry time to prepare.
Given that many stakeholders are still catching up with infrastructure and method readiness, successful compliance will require early ramp-up.
Fragrance Allergen Disclosure: What MoCRA Demands & What Is Coming
Unlike many cosmetic ingredients, fragrance components have historically been treated as proprietary blends (“parfum / fragrance”) and not individually disclosed on U.S. labels. MoCRA changes that.
Statutory Mandate & FDA Rulemaking Timeline
Under Section 609, MoCRA requires FDA to issue a list of substances that will be defined as fragrance allergens, and thereafter mandate their disclosure on cosmetic product labels.
Key dates and status:
- Originally, MoCRA required FDA to issue a notice of proposed rulemaking (NPRM) on fragrance allergen labeling by June 29, 2024.
- That deadline has already passed, and industry commentary suggests delays in the issuance of the NPRM until May of 2026.
While the precise compliance date is not yet established, the timeline suggests that brands should expect to start changing labels within a few years of finalization.
Scope and Requirements (Expected)
Although the final rule is pending, industry guidance, drawing on how the EU and other jurisdictions handle fragrance allergens, suggests:
- A defined list of specific fragrant chemical substances (e.g., limonene, linalool, etc.) will be designated as “fragrance allergens” for U.S. regulation.
- When the concentration of a listed allergen exceeds specified thresholds in a product, it must be explicitly declared in the Ingredient Statement or adjacent labeling rather than hidden behind the term “fragrance”.
- The rule may distinguish between leave-on vs rinse-off formulations with different threshold levels, as seen in other jurisdictions.
- Labeling of fragrance allergens must be clear and prominent.
In short, formulators and compliance teams will need to know exactly which fragrance compounds are regulated, what threshold triggers the label requirement, and how to integrate this information into existing formulation and labeling systems.
Key Implications & Challenges for R&D, Compliance, and Manufacturing
The dual pressures of asbestos testing and allergen disclosure impose significant demands at all stages of product development and production. Below are critical domains to address:
Method Capability, Validation & Throughput
- Many manufacturers will need to partner with testing labs that are capable of running both PLM (dispersion-stained) and TEM/EDS/SAED methods in a validated and compliant fashion.
- Method validation will be essential: ensuring limit of detection, reproducibility, specificity, and quality control procedures under real-world sample matrices.
- Throughput demand may rise sharply if every batch or ingredient lot must be tested or verified via CoA.
- Turnaround time will directly affect production scheduling and inventory release cycles.
Supply Chain Qualification & Audits
- Reliance on supplier CoAs is permitted, provided the supplier is well-qualified and subject to manufacturer verification. That requires audits, incoming verification testing, controls on change management, supplier agreements, and traceability.
- Brands must evaluate existing talc suppliers to ensure they can meet dual-method testing (PLM + TEM) and can provide robust documentation. If not, alternate qualified suppliers are needed.
- For fragrance ingredient suppliers, brands must demand disclosure of constituent compounds and purity data to support allergen screening and threshold calculations.
Formulation & Component Assessment
- Formulators must know their fragrances at the component level, or at least be aware of whether any fragrance allergens are present above the threshold. This may lead to changes in supplier relationships, such as a preference for prequalified hypoallergenic fragrance blends or the reformulation of existing blends.
- For existing products, a retrospective audit of fragrance composition may be required to identify allergens above threshold, possibly triggering a label change or reformulation.
Labeling Systems, Change Control & Versioning
- Product label systems must be ready to incorporate additional allergen disclosures. This may require retooling of label templates, translation, regulatory review, planning of packaging print runs, and implementation of change control systems.
- For products already in market or in pipeline, migrating to new label versions will need coordination across inventory, packaging, logistics, and marketing timelines.
- Change control must ensure that any formula change to fragrance supplier, source, or concentration triggers a reassessment of allergen impact and label suitability.
Quality Systems & Documentation
- Companies must integrate these new requirements within their GMP / quality management system (QMS), linking analytical testing, specification limits, documentation retention, change control, deviation management, and audits.
- Traceability, batch records, certificate-of-analysis linking, and failure investigation must be robust.
- SOPs, training, audits, and oversight mechanisms must be updated.
Timing & Risk Mitigation
- Delays in method adoption, supplier upgrades, label changes, or staffing could lead to non-compliance or forced product withdrawals.
- Brands must plan buffer periods for analytical validation, supplier audits, label revisions, manufacturing runs, and inventory transitions.
- Given that enforcement often follows a “grace period,” waiting until the last moment increases risk, especially for complex portfolios.
Roadmap: What Cosmetic Firms Should Be Doing Right Now
To be ready when the regulations go live, planning out your compliance roadmap is key.
Phase 1: Strategic Gap Assessment (Now–Next 3 Months)
- Audit your existing product portfolio to identify:
• Products containing talc (face powders, body powders, etc.)
• Products with fragrances or aroma compounds - Inventory your current supplier roster for both talc and fragrance, and assess whether they can provide dual-method testing and full disclosure of allergens.
- Map label systems, packaging inventory, and change control processes to identify bottlenecks in label updates.
- Engage with your C-suite and regulatory leadership to secure budget and buy-in for method development, vendor contracts, and lab capacity expansion.
Phase 2: Capability Build & Supplier Qualification (3–9 Months)
- Begin method development/validation for PLM + TEM/EDS in your lab or with a partner or contract with laboratories that already have validated systems.
- Conduct supplier audits & qualification for talc suppliers, ensuring they can issue CoAs with dual-method testing, and fragrance suppliers to ensure they can provide compound-level disclosure.
- Negotiate contracts and agreements that formalize data sharing, change notification, and verification rights.
- Run side-by-side tests on existing batches and retained samples to assess baseline compliance and spot potential issues before they become a major concern.
Phase 3: Labeling & Packaging Transition (6–15 Months, overlapping with Phase 2)
- Update label templates and systems to allow allergen disclosure fields.
- Plan packaging print runs and align label change timelines with manufacturing schedules.
- Coordinate with marketing and regulatory to ensure new batches entering the market will carry compliant labels.
- For products in the pipeline or in inventory, plan for transition phases to replace older label stocks.
Phase 4: Full Compliance Readiness (Prior to Enforcement Date)
- Validate all testing workflows, finalize SOPs, and train QA staff.
- Ensure all current and future batches of talc-containing products are tested or backed by qualified supplier CoAs.
- Ensure that all fragrance formulations have been screened for allergens and that labels have been updated accordingly.
- Conduct internal audits, data integrity checks, and mock inspections to confirm readiness.
- Retain full documentation to demonstrate compliance in case of FDA inspection.
Phase 5: Post-launch Monitoring & Continuous Compliance
- Monitor supplier changes, raw material sourcing, and reformulations to assess downstream allergen and asbestos risk.
- Periodically audit supplier CoAs vs in-house validation results.
- Maintain vigilance on future MoCRA rulemakings such as potential rules regarding GMP, PFAS, and other categories and be ready to adjust to any subsequent requirements.
Why Working with an Experienced Laboratory & Partner Matters
Attempting to do all of this in-house can be high-risk. Partnering with a lab or consultancy with proven capability offers major advantages.
Method Readiness & Validation Expertise
An experienced lab will already have or can quickly build qualified PLM + TEM/EDS workflows, reducing your development burden and timeline
Capacity Scaling & Throughput
Labs can absorb high sample volumes, allow you to ramp gradually, and smooth peak loads
Supply Chain Audit Support
Labs or regulatory consultants can assist in auditing and qualifying talc and fragrance suppliers, evaluating CoAs, and negotiating testing obligations
Training, Documentation, and QMS Support
Labs with robust consulting departments can assist with building SOPs, QA oversight, audit readiness, data systems, and regulatory dossiers.
Mock Inspections & Readiness Assessments
Before enforcement dates, an independent lab partner can help you stress-test your systems and uncover weak spots.
Cost Efficiencies
By sharing capital investments, bulk testing economies of scale, and leveraging lab infrastructure you can meet the required regulations without outfitting a new lab of your own.
At CPT℠ Labs, we can support your path to compliance by providing:
- Validated dual-method asbestos-in-talc testing (PLM + TEM/EDS/SAED), method development, and batch-level testing and verification
- Fragrance allergen screening, substance-level identification, threshold evaluation, and label-compatibility analysis
- Supplier qualification audits, CoA verification, and change control frameworks
- Documentation, training, and quality system integration for MoCRA compliance
Engaging early with a skilled lab partner lets you smooth out logistical, analytical, and operational hurdles ahead of enforcement. It’s far safer to scale method capacity, uncover surprises, and fix issues in lower-risk conditions than to race at the last moment.
Conclusion: Don’t Wait. The Clock Is Ticking.
The asbestos-in-talc and fragrance allergen rules under MoCRA represent transformative change for the cosmetics industry. Leading brands that proactively prepare will gain a competitive advantage by avoiding last-minute disruptions, recall risk, or regulatory penalties.
The time to begin preparations for these rulings is now. Audit your portfolio, qualify suppliers, build or partner for testing capability, and align your label and packaging pipeline.
Contact us today to start developing your plan for compliance.