Selling cosmetics in the United States or the European Union requires strict compliance with safety, labeling, and documentation standards—whether selling online or offline. No pre-market “certificates” are required, but certain safety reports and regulatory filings are legally mandated.
This guide outlines exactly what documentation you need, how much it costs, and whether online sales differ in regulatory expectations.
1. United States – Compliance Under MoCRA (Modernization of Cosmetics Regulation Act)
Since December 29, 2023, the U.S. FDA enforces the MoCRA, which is the most significant overhaul of cosmetic regulation in decades.
✅ Mandatory Requirements
| Requirement | Details |
|---|---|
| Facility Registration | Every manufacturer/importer must register with the FDA and renew every 2 years. |
| Product Listing | Each product must be listed with its ingredients and intended use. |
| Adverse Event Reporting | Brands must track and report serious health-related complaints to the FDA. |
| Safety Substantiation | Documentation proving the product is safe under intended conditions of use. |
✅ Optional but Recommended
Good Manufacturing Practices (GMP): Not mandatory yet, but FDA plans to issue GMP regulations by late 2025.
Third-party lab testing (e.g., microbiological testing, preservative efficacy testing) enhances credibility.
💵 Estimated Costs
| Service | Price Range |
|---|---|
| Safety Report (by toxicologist) | $1,500–$4,000 per product |
| Regulatory Consultant | $100–$250/hour |
| GMP Implementation Support | $2,000–$10,000 (project-based) |
📘 Reference: FDA MoCRA Overview
2. European Union – Regulation (EC) No 1223/2009
To sell cosmetics in the EU, compliance with Regulation (EC) No 1223/2009 is mandatory. Products must not only be safe, but also traceable, labeled correctly, and notified to the EU system.
✅ Legal Obligations
| Requirement | Description |
|---|---|
| CPSR (Cosmetic Product Safety Report) | Must be conducted by a qualified safety assessor before launch. |
| Product Information File (PIF) | A dossier containing safety reports, manufacturing process, proof of claims, etc. |
| Responsible Person (RP) | An EU-based entity or individual legally accountable for compliance. |
| CPNP Notification | Free online notification before placing products on the EU market. |
💵 Estimated Costs
| Service | Price Range |
|---|---|
| CPSR Report | €500–€2,500 per product |
| RP Service (Outsourced) | €1,000–€3,000/year |
| PIF Preparation (if outsourced) | €500–€1,500 per product |
📘 Reference: EU Cosmetic Regulation Portal
3. Online vs. Offline Sales: Are There Regulatory Differences?
In both the US and EU, regulatory obligations are the same regardless of sales channel. Whether you sell via e-commerce platforms like Amazon, Etsy, or in brick-and-mortar stores, the product must meet identical safety and labeling standards.
⚠️ Additional Considerations for Online Sales
| Factor | Detail |
|---|---|
| Customs & Import Controls | Border checks may require documentation such as invoices, CPSRs, or MoCRA filings. |
| Platform Requirements | Marketplaces like Amazon often ask for proof of compliance (e.g., safety report, MoCRA listing). |
| Language Requirements | EU labels must include translations in the official languages of each country where the product is sold. |
| Digital Product Claims | Online listings must reflect accurate claims that match your PIF and CPSR documentation. |
✅ Summary Table
| Area | US (MoCRA) | EU (Reg. 1223/2009) |
|---|---|---|
| Pre-Market Approval | ❌ Not required | ❌ Not required |
| Safety Report | ✅ Required | ✅ Required (CPSR) |
| Labeling Rules | ✅ FDA-compliant | ✅ Multi-language + INCI |
| Market Notification | ✅ Product Listing | ✅ CPNP Notification |
| Responsible Entity | ✅ US address | ✅ EU Responsible Person |
| Cost Estimate | $1,500–$5,000+ | €1,000–€4,000+ |
Final Note
Whether you’re launching a new private label cosmetics brand or expanding through cosmetics contract manufacturing, understanding your target market’s regulatory landscape is crucial. While neither the US nor EU requires pre-market certification, both demand detailed documentation and traceability.
Working with a knowledgeable manufacturer—like Aurora Global Brands, which supports both compliance and production—can help ensure your brand enters the market safely and confidently.
