The short answer
Poland is one of Europe’s biggest producers of apples and apple juice concentrate, and exports frozen fruit, confectionery, cosmetics and vodka to the U.S. Juice has its own FDA rules.
What Polish exporters should watch for
🍎 Apple juice concentrate
Juice processors must follow FDA’s juice HACCP rule (21 CFR Part 120). FDA has an action level of 50 ppb for patulin in apple juice and juice concentrate, so test each lot.
🍓 Frozen fruit
Freezing and packing plants register with FDA. U.S. buyers expect strong hygiene, water testing and traceability for frozen berries and fruit.
✨ Cosmetics
Poland has a large cosmetics industry. For the U.S., factories need MoCRA facility registration, product listing, a U.S. Agent and a U.S. adverse event contact on the label; the EU Responsible Person does not count.
🍬 Confectionery and vodka
Confectionery must use FDA-approved colors and declare U.S. allergens. Distilleries register with FDA as food facilities; labels and permits go through TTB.
Common reasons Polish shipments are stopped
- Juice HACCP not in place
- Patulin above the FDA action level
- Cosmetics not registered or listed under MoCRA
- Colors not approved by FDA
- Labeling — EU nutrition panel, metric-only weights
🏢 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 Polish apple juice concentrate need juice HACCP?
Yes. Processors of juice and juice concentrate sold in the U.S. must have a juice HACCP plan under 21 CFR Part 120, and FDA has an action level of 50 ppb for patulin in apple juice. The plant must also register with FDA.
Do Polish cosmetics brands need MoCRA registration?
Yes. The facility that manufactures the cosmetics must register with FDA, each product must be listed, a U.S. Agent must be named, and the label must show a U.S. address, phone or website for adverse event reports.
Sources
- eCFR — 21 CFR Part 120, Hazard Analysis and Critical Control Point (HACCP) systems for juice
- FDA — Registration & Listing of Cosmetic Product Facilities and Products
- 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.