MoCRA's Facility Registration and Product Listing: What US Cosmetic Brands Are Still Getting Wrong

Eighty-five years. That’s how long it took Congress to give FDA meaningful authority over cosmetic product safety. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — signed December 29, 2022, as part of the Consolidated Appropriations Act — represents the most significant expansion of FDA cosmetics oversight since Franklin Roosevelt was in office. And yet, the majority of brands we work with still have gaps in what MoCRA actually requires them to do.

This isn’t a minor compliance update. MoCRA gave FDA mandatory recall authority over unsafe cosmetics, established a federal product listing system, and — most critically for brands — codified a requirement to maintain records adequate to substantiate the safety of every cosmetic product on the market. That last requirement is where most brands are underexposed, and it’s exactly where a properly scoped cosmetic testing program needs to deliver.

What MoCRA’s Registration and Listing Requirements Actually Look Like

The two most visible MoCRA obligations are facility registration and product listing. Most brands addressed registration — or believe they did. Domestic cosmetic product facilities were required to register with FDA by December 29, 2023. Small businesses (those with $1 million or less in average annual US cosmetic product sales over the prior three years) had an extended deadline of December 29, 2024. Foreign facilities manufacturing cosmetics for US commerce faced the same schedules.

Registration is biennial, which means renewal is required every two years. Initial registrants are now in their first renewal cycle — a fact that’s caught more than a few brands off guard heading into mid-2026.

Product listing is a separate requirement and one that trips people up. Every cosmetic product must be listed with FDA, including the full ingredient declaration, the applicable product category using FDA’s defined taxonomy, and the facility where it’s manufactured or processed. Here’s what most brands miss: product listing must be updated within 180 days of any material change. Reformulating a preservative system, switching to a new contract manufacturer, adding an ingredient — any of those likely triggers an updated listing. The 180-day clock starts when the change is made, not when someone remembers to file.

FDA has not issued formal enforcement guidance specifically addressing product listing gaps, but the agency now holds mandatory recall authority under MoCRA. That authority isn’t theoretical. It’s available today.

The Safety Substantiation Requirement: More Than Just Running Tests

This is where most brands have the largest exposure. MoCRA requires the “responsible person” — typically the brand marketing the product in the US — to maintain records adequate to substantiate the safety of each cosmetic product and each ingredient used. FDA has signaled that existing documentation (formulation data, supplier safety sheets, toxicological literature, published CIR Expert Panel assessments) can contribute to substantiation. But “adequate” is doing a lot of work in that sentence, and FDA hasn’t yet defined it through rulemaking.

What a well-structured safety substantiation package looks like in practice — and what any experienced cosmetic testing lab operating under ISO 17025 would tell you to build — typically includes:

• Microbial safety: Finished product microbial limits testing per USP <61> and <62>, plus a preservative efficacy challenge (USP <51> or an equivalent compendial method) confirming the product resists microbial contamination throughout its intended shelf life.
• Chemical purity screening: Heavy metals testing (at minimum lead, arsenic, cadmium, and mercury) when formulas contain mineral pigments, clay, or botanical ingredients; and residual solvent analysis where relevant to the manufacturing process.
• Stability: Accelerated stability data, supported by real-time data where possible, for the claimed shelf life — particularly for water-containing emulsions, serums, and leave-on skin and hair care products.
• Ingredient-level safety review: Verifying that each ingredient’s concentration in the formula falls within established safe use ranges. ECHA’s cosmetic ingredient database, CIR monographs, and FDA guidance documents all provide relevant reference points.

None of this is a nice-to-have if you’re marketing cosmetics in the US. And if FDA sends an inspection notice or issues a records request, you will not have time to run those tests retroactively.

What a Cosmetic Testing Laboratory Should Be Delivering for MoCRA

A compliant MoCRA testing program isn’t a list of assays — it’s a documentation architecture. The test reports, the COA review summaries, the stability data, the safety narrative — all of it needs to be organized so it can be presented to FDA as a coherent, product-specific package if ever requested.

Here’s the documentation structure we recommend brands build before they need it:

1. A product-specific safety substantiation file. Not a single test report — a structured folder that includes the formula at the version tested, ingredient-level safety references, finished product test results, and a written safety rationale explaining why the product is safe as intended for use. Some US brands model this on the EU’s Annex I cosmetic safety report format even when selling only domestically. That level of rigor tends to hold up in any regulatory environment.

2. ISO 17025 accredited test reports. Not all test data carries equal evidentiary weight with FDA. Reports from an ISO 17025 accredited cosmetic testing laboratory demonstrate that the lab’s methods are formally validated, calibration is metrologically traceable, and measurement uncertainty is documented and controlled. When FDA evaluates whether your substantiation is “adequate,” an accredited report is substantially more defensible than data from a non-accredited source or an in-house quality control result.

3. Lot-level traceability. Safety substantiation at the product level is the baseline. When a specific ingredient lot from a specific supplier appears in a product subject to a serious adverse event or potential recall, you need batch-level linkage between your testing records and your production documentation. Most brands underinvest in this connection until they urgently need it.

4. A reformulation trigger process. Every time a formula changes, the safety substantiation is partially invalidated for the affected elements. The preservative efficacy test run 18 months ago doesn’t cover the new emollient system added last quarter. Build a process that flags formulation changes and routes them into a re-testing review before the updated formula ships.

MoCRA’s Fragrance Allergen Labeling and Adverse Event Reporting

Two additional MoCRA provisions are creating compliance gaps that don’t always register with brands focused on registration and product listing.

Fragrance allergen labeling became effective December 29, 2025. MoCRA requires 26 specific fragrance allergens — a list that maps closely to the EU’s established catalog and includes compounds like linalool, limonene, citronellol, eugenol, and geraniol — to be declared on product labels when present above defined concentration thresholds. For leave-on products, the threshold is 0.001%. For rinse-off products, it’s 0.01%. Brands reformulating to stay below these thresholds, or verifying current formulas, need analytical methods capable of detecting these compounds at sub-ppm concentrations. That means GC-MS, and not every lab has validated methods at those detection limits.

Serious adverse event reporting requires responsible persons to notify FDA within 15 business days of receiving information about a serious adverse event associated with a cosmetic product. Under MoCRA, a “serious adverse event” includes hospitalization, disfigurement, disability, congenital anomaly, or any event requiring medical or surgical intervention. If a customer service inquiry or social media report describes symptoms that meet that threshold, the 15-day clock starts at receipt. Brands without documented adverse event intake and triage procedures — specifically, someone trained to recognize a qualifying event and escalate it — are the most exposed here.

Getting Your Documentation in Order Before FDA Asks

FDA’s MoCRA enforcement capacity is building deliberately. The agency is still finalizing cosmetic GMP regulations — a proposed rule is expected, with the final rule timeline extending into 2027 at the earliest. That creates a window for brands to organize their compliance documentation, but it isn’t an indefinite one.

The brands in the strongest position are those that treated MoCRA as an infrastructure build, not a filing exercise. They registered on time, listed their products, assembled a safety substantiation file per SKU, and embedded cosmetic testing into their product launch checklist. The brands most at risk are those that registered (or think they registered) and stopped there, assuming the hard part was done.

If you’re not certain your current testing documentation meets the “adequate substantiation” standard MoCRA demands, that uncertainty is worth resolving now. A credentialed cosmetic testing laboratory can audit your existing test data, map the gaps against what FDA would expect to see, and design a testing scope that closes them — before you’re producing records under a compliance deadline you didn’t anticipate.

MoCRA changed the rules. The question is whether your documentation reflects that yet.

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Written by Nour Abochama, Vice President of Operations, Qalitex Laboratories. Learn more about our team

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