The short answer
Portugal exports canned sardines and tuna, olive oil, port and other wines, cheese and cosmetics to the U.S. Canned fish is the most regulated of these.
What Portuguese exporters should watch for
🐟 Canned sardines and tuna
Canneries need FDA facility registration, FCE registration and an SID process filing for each product and container size, and must follow seafood HACCP with histamine control.
🫒 Olive oil
Olive oil is watched for economic adulteration under Import Alert 99-47. Keep grade and authenticity test results for each lot.
🍷 Port and wine
Wineries register with FDA as food facilities and file Prior Notice; labels and permits go through TTB.
🧀 Cheese and cosmetics
Raw-milk cheeses such as Serra da Estrela must be aged at least 60 days at no less than 35°F (1.7°C). Cosmetics need MoCRA registration and product listing.
Common reasons Portuguese shipments are stopped
- Canned fish without FCE/SID or HACCP
- Histamine in sardines and tuna
- Raw-milk cheese aged less than 60 days
- Labeling — EU nutrition panel, metric-only weights
- Cosmetics not registered 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
Do Portuguese sardine canneries need FCE and SID?
Yes. Canned sardines and tuna are low-acid canned foods, so the cannery needs FCE registration and an SID filing for each product and container size, plus FDA food facility registration and a seafood HACCP plan.
Does a port wine producer need FDA registration?
Yes. Wineries exporting to the U.S. must register with FDA as food facilities and file Prior Notice for each shipment. TTB separately approves labels and issues import permits.
Sources
- FDA — Acidified & Low-Acid Canned Foods (LACF) registration
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
- eCFR — 21 CFR Part 133, Cheeses and related cheese products
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.