Regulatory Studio — cosmetics compliance

Know your formula is legal to sell.

Upload a formula. See how it screens against the rules in 15 markets. Every flag links to the regulation it comes from, so you can check the source yourself.

Hydrating Face SerumUS + EU · 24 ingredients
Methylisothiazolinone
Reg. (EU) 2017/1224 · Annex V
0.0015% rinse-off only
Homosalate
Reg. (EU) 2022/1176 · Annex VI
7.34% face products
22 other ingredients
US & EU restriction lists
No restrictions
15
Markets
33,000+
Ingredients tracked
1,300+
Restrictions on file
100%
Cited to source
Every rule we apply comes from one of these texts
21 CFR Parts 700–740 EU Annexes II–VI · Reg. (EC) 1223/2009 SCCS Opinions CIR Safety Assessments Health Canada Hotlist CosIng Database Federal Register ISO 22716 GMP
Who it's for

Everyone who has to
sign off on a formula.

The people who keep a formula legal rarely work in the same building. They all read from the same cited record here.

01

Beauty Brands

Screen every SKU before launch, keep your PIF and MoCRA filings current, and hear about a rule change as it happens.

02

Contract Manufacturers

Clear formulas for every client and market from one workspace. Use the API to run the same screening inside your own systems.

03

Consultants

Run the screening, build the documents, prepare the filings. Every finding cites its source, so you can hand it to a client or an authority as it stands.

04

Retailers

Check that vendor formulas meet your clean program. We screen against the published criteria and cite every rule we apply.

How it works

From ingredient list to cited report in three steps

You do this yourself, in minutes, without hiring a consultant.

01

Upload your formula

Drop in a CSV, Excel, or PDF ingredient list, or paste plain INCI text. We match each name against a database of more than 33,000 ingredients.

02

Pick your markets

Choose any of 15 markets, from the US and EU to the UK, Canada, Japan, Korea, China, Australia, Brazil, India, Singapore, Thailand, UAE, Mexico, and Taiwan.

03

Read the cited report

We check each ingredient against every market you picked, at the concentration you gave. Each flag links to the regulation behind it.

The platform

The software does the regulatory work

Screening, documents, and filings. Not a dashboard that hands you a to-do list and points you to a consultant.

Multi-market screening

Every ingredient, every market, every flag cited

Screen against EU Annexes II, III, V and VI, US restrictions, the Health Canada Hotlist, and more. We hold over 1,300 restrictions, and each one links to the text it came from.

MoCRA

MoCRA submission packages

FDA facility registration and product listing with generated, validated SPL XML and a submission-ready ESG package — you file from your own FDA ESG account.

Safety

Adverse event handling

Log events, generate MedWatch Form 3500A, and track the 15-business-day reporting deadline. Records retained per MoCRA's 6-year rule (3 years for qualifying small businesses).

EU dossier

EU Product Information File

Build and maintain the PIF required by Article 11 of Regulation (EC) 1223/2009, organized per product and ready for a competent-authority request.

Labels

Label generator

Generate market-ready label content — INCI ingredient ordering, required warnings, and mandatory statements for your target markets.

US state law

13 enacted state laws in one screen

PFAS bans (CA, CO, MN, ME, CT, RI, NM), restricted-ingredient lists (WA, MD, VT, OR), California Prop 65's 990 listed substances, and New York's 1,4-dioxane limits — every flag carries the statute's verbatim text.

EU allergens

EU fragrance allergen labelling

All 81 individually-labelled allergen entries under Reg. (EU) 2023/1545, checked against declared concentrations at the 0.001% leave-on / 0.01% rinse-off thresholds — with the 2026/2028 transition deadlines tracked per product.

Change control

Formula change control

Every formula edit is snapshotted automatically — versioned diffs plus a re-screening delta showing exactly which compliance flags a change introduced or resolved.

Claims

Claims substantiation review

Marketing claims checked against FDA's published drug-claim examples, the FD&C cosmetic/drug boundary, EU Reg. 655/2013 common criteria, and FTC substantiation guidance — an AI review that cites only the verbatim regulatory texts.

Operations

A rule changes. You hear about it first

The rules keep moving after you file. Regulatory Studio watches the sources and re-screens your catalog when one of them changes.

Regulatory feed Live

Weekly regulatory scans

Every week we scan FDA publications and SCCS opinions and post what changed to your dashboard and inbox, before your retailer emails you about it.

Automatic re-screening

When a source we track changes, we re-screen your whole catalog and show you, product by product, which flags the change opened or cleared. If nothing changed for you, we stay quiet.

Flag and resolution vault

Every flag keeps a full disposition history and a document store for CoAs and substantiation. When a document expires, we reopen the flag, so your evidence never lapses without warning.

Integrations

Where Regulatory Studio plugs in

Everything listed here is live today — nothing aspirational.

Live

Retailer Clean Programs

Screen formulations against the published criteria of Clean at Sephora, Planet Aware, Ulta Conscious Beauty, Target Clean, and Walmart's Made Without List — every rule cited to the retailer's own documentation.

Live

EWG VERIFIED Screening

Check ingredients against EWG's Unacceptable List — 9,551 entries matched by exact name and CAS number from EWG's official criteria documents.

Live

Packaging EPR

State-by-state producer obligations for the 7 Circular Action Alliance states — registration deadlines, reporting cycles, and small-producer exemption checks with statutory citations.

Live

Shopify

Sync your live product catalog from Shopify — products import with INCI lists auto-extracted from listings, ready for compliance analysis.

Live

FDA ESG (NextGen)

Validated SPL XML and complete, submission-ready packages for facility registration and product listing.

Live

API Access & Brand Studio

Full REST API for labs, contract manufacturers, and consultants — plus one-call catalog sync from VAIN Brand Studio.

Coverage

What we do in each of the 15 markets

Some markets we take end to end. Others we screen and analyse. We spell out which is which, so you know what you are getting before you buy.

US
Fully Automated

End to end. MoCRA screening, facility registration, product listing, SPL generation, submission packages, adverse events, and labels.

EU
Dossier Preparation

Annex screening with citations, PIF assembly, and label content under Regulation (EC) 1223/2009.

+13
Screening & Analysis

Restriction screening and market analysis for the UK, Canada, Japan, Korea, China, Australia, Brazil, India, Singapore, Thailand, UAE, Mexico, and Taiwan.

How we compare

Software you run, not a service you pay per filing

The usual route to compliance is a consultant and a fee for each filing. Here is how the options line up.

Cosmedesk

  • EU-focused compliance software
  • PIF, CPSR, and label tooling
  • Credit-based pricing
  • Built around EU Reg. 1223/2009 workflows

Registrar Corp

  • US-focused FDA compliance service
  • Experts file on your behalf
  • Fees per facility and per product
  • A service you hire, not software you run
VAIN

Regulatory Studio

  • 15 markets in one platform, US automated end to end
  • Every flag cited to the regulation behind it
  • MoCRA packages, EU PIF, labels, and adverse events
  • Weekly monitoring and a flag-resolution vault
  • You run it yourself, from $150 per SKU
Free check

Does MoCRA fully apply to you?

Smaller brands skip some of MoCRA, though never all of it. Answer two questions to see which parts you have to meet.

1. Were your average gross annual US cosmetic sales over the last 3 years under $1 million?

2. Do any of your products contact the eye's mucus membrane, get injected, get ingested, or alter appearance for more than 24 hours?

Based on Section 612 of the FD&C Act, added by the Modernization of Cosmetics Regulation Act of 2022. Informational only — not legal advice.

Pricing

Start with one SKU. Grow from there.

Trade consultant hours and per-filing fees for software you run.

Starter

$150 per SKU, one-time
  • 1 product, multiple revisions
  • All 15 markets, verified citations
  • FDA ESG submission package
  • Email support
Check one product
Early Access

Growth

Talk to us catalog-wide, priced to fit
  • Full catalog, unlimited revisions
  • AI compliance analysis, 15 markets
  • Always-on monitoring & flag vault
  • Team workspace & API access
  • Priority support
Book a Demo

Screen your first formula this week

Book a walkthrough, or open a workspace and upload a formula today.