Short answer
The EU requires a product notification before placing a cosmetic on the market, filed through the Cosmetic Products Notification Portal (CPNP), backed by a Product Information File (PIF) and a designated Responsible Person in the EU. The US, under MoCRA, requires facility registration and product listing with the FDA, plus a responsible person and safety substantiation.
The practical difference for a private-label buyer is where the burden lands. In the EU, the Responsible Person must be an EU-established entity — that is you or your appointed agent, not your Chinese manufacturer. In the US, the facility registration is the manufacturer's obligation, while product listing and the US agent are typically handled by the brand or importer.
Both regimes require safety substantiation and both expect you to hold documents rather than hope someone else does. Ask your manufacturer specifically which documents they will supply, because 'compliant' on a website and 'we will hand you the PIF' are very different statements.
Side-by-side comparison
| Requirement | European Union (CPNP) | United States (MoCRA) |
|---|---|---|
| System basis | Regulation 1223/2009 | MoCRA (2022), FDA |
| Main filing | Product notification via CPNP | Facility registration + product listing |
| Who files | Responsible Person established in the EU | Manufacturer/processor registers; brand or importer lists |
| Core dossier | Product Information File (PIF) | Safety substantiation on file |
| Safety assessment | Cosmetic Product Safety Report by a qualified assessor | Adequate substantiation of safety |
| Responsible party | EU-established legal or natural person | US agent for foreign facilities |
| Labelling focus | Ingredient list, function, warnings, responsible person address | Ingredient list, identity, warnings, responsible person |
| Timing | Before placing on the market | Registration and listing within statutory deadlines |
When to choose which (and when not to)
| What you need | EU | US |
|---|---|---|
| An in-country responsible party | Yes — mandatory | Yes — US agent |
| Full formula disclosure to authority | To the Responsible Person / Poison Centre where required | To FDA for facility and product listing |
| Safety assessment by qualified person | Yes — CPSR | Substantiation required, assessor not specified |
| Manufacturer documentation pack | Yes — from us | Yes — from us |
| Stability and microbiology data | Yes | Yes |
| CPNP notification number before sale | Yes | Not applicable |
Frequently asked questions
Can the manufacturer be my EU Responsible Person?
No. The Responsible Person must be established in the EU. That is typically your importer, distributor, or an appointed compliance service.
What documents do you supply?
ISO 22716 / GMPC system documentation, stability and microbiology reports, and the formulation and manufacturing information needed for the PIF or US listing. Scope is confirmed per market before you commit.
Does having ISO 22716 mean the product is registered?
No. ISO 22716 certifies the manufacturing system. Product notification or listing is a separate, product-specific step.
How far ahead should I start compliance work?
Start it in parallel with sampling, not after. Documentation is usually on the critical path for the launch date, not the production date.
Formulating an eye-care product?
Send your target market, dosage form and estimated quantity — we reply with formulation advice, MOQ tiers, compliance notes and samples.
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EyeOEM · Eye-Care OEM/ODM R&D & Manufacturing · 2026-09-11 · sales@eyeoem.com