Free tool · Updated June 2026

MoCRA Compliance Checker for Beauty Brands

Answer five questions and get your brand's exact obligations under the Modernization of Cosmetics Regulation Act — what applies to you, what you're exempt from, and which FDA rules are still coming. Then print the checklist.

Renewal wave is now: facilities that registered with FDA by the July 1, 2024 deadline must complete their first biennial registration renewal by July 1, 2026 (or two years from their initial registration date). FDA began sending automated renewal reminders via Cosmetics Direct in February 2026.

1Annual US cosmetics revenue3-year average

2Higher-risk product types

Check any that apply — these void the small business exemption:

3Who manufactures your products?

4Product details

5Where are products made?

Your MoCRA profileSmall business — partial exemption

You qualify for the MoCRA small business exemption: no facility registration or product listing. Core safety, labeling and adverse-event duties still apply.

Applies to every brand — no exemption
Required
Responsible person + adverse-event contact on every label
Your label must name the responsible person and carry a US address, phone number, or electronic contact for adverse event reports. In force since Dec 29, 2024. Reserve this line in your label dieline.
Required
Serious adverse event reporting
Report serious adverse events to FDA within 15 business days (MedWatch Form 3500A), with follow-up for 1 year. Keep records 3 years.
Required
Safety substantiation records
Maintain adequate evidence (testing, studies, or existing safety data) that each product is safe as used. Tie records to specific formulations and batch codes.
Registration & listing
Exempt
Facility registration
Exempt — you qualify as a small business (under $1M, no higher-risk products). If you cross $1M on a 3-year average, registration is due within 60 days of losing the exemption.
Exempt
Product listing
Exempt as a small business. Consider listing voluntarily — some retailers and insurers ask for proof of listing regardless.
Watch — rules finalizing
Watch
Fragrance allergen labeling
Proposed rule expected mid-2026, final no earlier than 2027, then a compliance window. Budget 1–4 extra label lines. EU sellers: the EU's expanded allergen rules already apply.
Watch
Good Manufacturing Practices (GMP)
Delayed to FDA's long-term agenda — no rule expected within 12 months. Small businesses will be exempt when it lands. Expected to draw on ISO 22716; ask your manufacturer for their certificate today.

Every MoCRA deadline — done, due, and still coming

RequirementWho it hitsDateStatus (June 2026)
Safety substantiation recordsAll responsible personsDec 29, 2023In force
Serious adverse event reportingAll responsible personsDec 29, 2023 · 15 business days per eventIn force
Professional-use labeling statementSalon/spa productsDec 29, 2023In force
Facility registration (Form 5066 / Cosmetics Direct)Manufacturers & processors, incl. foreignJul 1, 2024In force
Product listingResponsible persons (unless small-biz exempt)Jul 1, 2024 · new products within 120 days of marketingIn force
Adverse-event contact on label (US address, phone, or e-contact)All cosmetic labelsDec 29, 2024In force
Biennial registration renewalAll registered facilitiesJul 1, 2026 (or 2 yrs from initial registration)Due now
Talc: standardized asbestos testingTalc-containing productsProposed Dec 2024 · final rule targeted Mar 2026Finalizing
Fragrance allergen labelingProducts containing fragranceProposed rule expected mid-2026 · final ≥ 2027Proposed rule pending
Good Manufacturing Practices (GMP)Manufacturing facilitiesStatutory deadline missed; moved to FDA long-term agendaDelayed — not expected within 12 mo

What MoCRA means for your packaging & labels

Label real estate

Reserve space before you print

The adverse-event contact line (US address, phone, or electronic contact) is mandatory on every label now — and fragrance allergen disclosure will likely add 1–4 lines within a couple of years. On a 40×60 mm dropper-bottle label, that's real space. Plan for it now so you don't re-plate your labels in 2027.

Reorders

Don't overstock pre-rule labels

With fragrance allergen labeling finalizing in the next cycle, avoid printing 18 months of label inventory. Quarterly label reorders keep you agile — and most label printers' price breaks flatten out past 10K units anyway.

Suppliers

Your CM registers; you list

If a contract manufacturer makes your product, they register the facility — but you, as responsible person, file the product listing and need their FDA Establishment Identifier (FEI) number to do it. Ask for the FEI and registration confirmation before signing a production run.

Frequently asked questions

What is MoCRA in plain terms?
The Modernization of Cosmetics Regulation Act of 2022 — the first major update to US cosmetics law since 1938. It gives FDA mandatory recall authority and requires facility registration, product listing, safety substantiation, adverse event reporting, and new labeling elements for cosmetics sold in the US.
Does the $1M small business exemption cover everything?
No — and this is the most common misunderstanding. Small businesses (under $1M average gross annual US cosmetics sales over 3 years) are exempt from facility registration, product listing, and the future GMP rule. They are not exempt from safety substantiation, serious adverse event reporting, the responsible-person contact on labels, or professional-use labeling. And the exemption vanishes entirely if you make eye-area, injected, internal-use, or 24-hour-wear products.
I use a contract manufacturer. Do I still have to register?
Your CM registers their facility. You — as the brand owner / responsible person named on the label — file the product listing (unless small-business exempt), maintain safety substantiation, and handle adverse event reports. You'll need your CM's FEI number for the listing.
What is the July 1, 2026 renewal everyone is talking about?
Facility registrations renew every two years. The big first wave registered by the July 1, 2024 deadline, so their renewals are due by July 1, 2026 — though technically your renewal date is two years from your initial registration date. FDA's Cosmetics Direct portal now shows a "Renewal Date" field and emails reminders. Renewal is free.
Is FDA's GMP rule for cosmetics in force?
Not yet. The statutory deadlines (proposed rule Dec 2024, final Dec 2025) were missed, and FDA has moved the GMP rulemaking to its long-term agenda. Expect it to draw on ISO 22716. Smart move: ask your contract manufacturer for their ISO 22716 or equivalent GMP certificate today — retailers increasingly require it regardless of FDA timing.
When do I have to list fragrance allergens on my label?
Not yet — FDA's proposed rule is expected mid-2026, with a final rule no earlier than 2027, followed by a compliance window. But the EU already requires expanded allergen labeling (80+ allergens, fully phased by 2026–2028), so if you sell into Europe you're doing it already. US-only brands should at minimum keep label space in reserve.
Does MoCRA apply to soap?
True soap (alkali + fat, marketed only as soap) is regulated by the CPSC, not FDA, and sits outside MoCRA. But most "soap" products that moisturize, deodorize, or make cosmetic claims count as cosmetics — and syndet bars are cosmetics by default.
What records do I actually need to keep?
Safety substantiation (tests, studies, or existing literature adequate to support each product's safety) and adverse event records — 6 years for standard businesses, 3 years for small businesses. Keep them tied to specific formulations and batches; your batch coding scheme is what links a customer complaint back to a production run.

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This checker is general information for planning, not legal advice — MoCRA obligations depend on your specific products and facts. Verify against FDA's current guidance at fda.gov/cosmetics or with regulatory counsel. Rule statuses shown as of June 2026.