Short answer
Every export order needs two categories of paperwork: product documentation (what is in the formula and how it was made) and market registration (what the destination regulator requires). Confusing the two is the most common reason a first shipment gets held.
The core product documents are: the Product Information File (PIF), the INCI declaration, the Safety Data Sheet (SDS), the Declaration of Conformity (DoC) and the Certificate of Analysis (COA) for the batch. EyeOEM can ship all five with an order.
Market registration is separate. For the EU that means CPNP notification; for the US, MoCRA facility and product listing. Both need the product documentation as input — which is why requesting documents late is what actually delays market entry.
Side-by-side comparison
| Document | Purpose | Who needs it | Issued by |
|---|---|---|---|
| PIF | Product information file required in the EU | EU responsible person | Manufacturer |
| INCI | Ingredient naming for labelling | Labelling and marketplaces | Manufacturer |
| SDS | Safe handling and transport | Freight, warehouses | Manufacturer |
| DoC | Declaration that the product meets applicable rules | Importer, regulator | Manufacturer |
| COA | Batch-specific test results | Importer, retailer QA | Manufacturer QC |
| CPNP notification | EU market placement | EU market | Responsible person |
| MoCRA listing | US market placement | US market | US responsible party |
When to choose which (and when not to)
| Selling into | Add to the document set |
|---|---|
| EU | PIF plus CPNP notification |
| US | MoCRA facility and product listing |
| Retail or marketplace | COA per batch, INCI for listing |
| Multiple markets | Ask for the full set once, reuse everywhere |
Frequently asked questions
Can I get these documents before I order?
You can review the document set during sampling. Batch-specific documents such as the COA can only be issued for an actual production batch.
Who is the responsible person in the EU?
The brand or its appointed EU representative — not the manufacturer. This is your side of the paperwork, and it is worth appointing early.
Does documentation add lead time?
Not if requested up front. We prepare the set alongside production; requesting it after the run is what creates delay.
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.
Request a Quotation Free SamplesRelated: EU CPNP vs US MoCRA · lead time guide · ask for the document set
EyeOEM · Eye-Care OEM/ODM R&D & Manufacturing · 2026-09-11 · sales@eyeoem.com