The short answer
Belgium exports chocolate, biscuits and waffles, beer, frozen fries and medicines to the U.S., and the port of Antwerp handles goods from many other countries. EU compliance is strong, but U.S. labels and registration rules differ.
What Belgian exporters should watch for
🍫 Chocolate and pralines
Chocolate makers register with FDA. Labels need U.S. Nutrition Facts and the U.S. major allergens — milk, soy, tree nuts, peanuts, wheat, egg and sesame — and colors must be FDA-approved.
🧇 Biscuits, waffles and fries
Bakeries and frozen food plants register with FDA. Labels need English ingredients and Nutrition Facts; net weight must be in ounces and grams.
🍺 Beer
Breweries register with FDA as food facilities and file Prior Notice; labels and permits go through TTB.
💊 Medicines and re-exports
Under the EU–US MRA, FDA can rely on EU GMP inspections, but drug registration, NDC and listing are still required. Antwerp warehouses that hold food for the U.S. must register.
Common reasons Belgian shipments are stopped
- Undeclared allergens under the U.S. list
- Labeling — EU nutrition panel, E-numbers, metric-only weights
- Color additives not approved by FDA
- Wrong facility registered for re-exports
- Drug listings not renewed
🏢 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
Do Belgian chocolatiers need FDA registration?
Yes. Any facility making or packing chocolate for the U.S. must register with FDA and name a U.S. Agent, and each shipment needs Prior Notice. The label must meet U.S. rules, including the Nutrition Facts panel and the U.S. major allergen list.
Does an Antwerp warehouse need FDA registration?
If it holds food going to the U.S., yes — warehouses are holding facilities under FDA’s rules. A trading or forwarding company that never stores the goods does not register, but the manufacturer must.
Sources
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
- EMA — EU–US mutual recognition agreement for inspections
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.