The short answer
The Netherlands exports cheese, cocoa and chocolate, beer, processed foods, cosmetics and medical devices to the U.S. — and through Rotterdam it re-exports products made all over the world. Knowing which facility must register with FDA is the key question.
What Dutch exporters should watch for
📦 Re-exports through Rotterdam
FDA registration is for facilities that manufacture, process, pack or hold food. A Dutch warehouse or cold store that holds food for the U.S. must register; a trading office that never handles the goods does not. The original manufacturer must also register, and Prior Notice must name it.
🧀 Cheese
Cheese made from unpasteurized milk must be aged at least 60 days at no less than 35°F (1.7°C) before sale in the U.S. Labels need U.S. Nutrition Facts and net weight in ounces and grams.
🍫 Cocoa and beer
Cocoa processors and chocolate makers register with FDA and use only FDA-approved colors. Breweries register as food facilities, with labels and permits handled by TTB.
🩺 Devices and cosmetics
CE marking is not FDA clearance: devices need FDA registration, listing and often a 510(k). Cosmetics need MoCRA facility registration and product listing; the EU Responsible Person does not count.
Common reasons Dutch shipments are stopped
- Wrong facility registered for re-exported goods
- Raw-milk cheese aged less than 60 days
- Labeling — EU nutrition panel, E-numbers, metric-only weights
- Devices sold on CE marking alone
- Cosmetics not registered or listed under MoCRA
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your products — we’ll confirm what you need to register, in writing, by email.
Frequently asked questions
Does a Dutch warehouse need FDA registration?
If it holds food that is going to the U.S., yes — warehouses and cold stores are “holding” facilities under FDA’s rules and must register and name a U.S. Agent. A trading company that only buys and sells without storing the goods does not register, but the manufacturer must.
Can Gouda and other Dutch cheeses be exported to the U.S.?
Yes. Pasteurized cheeses can be exported once the facility is registered and the label meets U.S. rules. Cheeses made from raw milk must be aged at least 60 days at no less than 35°F (1.7°C) first.
Sources
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
- eCFR — 21 CFR Part 133, Cheeses and related cheese products
- FDA — Registration & Listing of Cosmetic Product Facilities and Products
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.