Two sets of obligations, on two different parties
US import requirements for food are not a single checklist held by the exporter. They divide between the foreign facility that manufactures, processes, packs or holds the food, and the US-based importer that brings it in. Each side has duties the other cannot discharge.
An Egyptian processor can be entirely in order and the consignment still refused because the US importer has no Foreign Supplier Verification Program for that supplier and that food. The reverse is equally true. Settle who is doing what before the first order, not at the port.
| Foreign facility | Registers with FDA, keeps the registration renewed, designates a US agent, and operates to the preventive controls standard the importer will verify against. Read it |
|---|---|
| US importer — the FSVP importer | Develops, maintains and follows an FSVP for each foreign supplier and each food, and identifies itself at each line entry. Read it |
| Filer or customs broker | Submits prior notice and entry data to FDA through the CBP systems, within the statutory timings. Read it |
Food facility registration and the US agent
A facility that manufactures, processes, packs or holds food for consumption in the United States must register with FDA before it begins to do so. The requirement reaches foreign facilities, not only domestic ones, and it sits in 21 CFR part 1, subpart H.
Registration is not permanent. Under 21 CFR 1.230 a renewal must be submitted during the period beginning 1 October and ending 31 December of each even-numbered year. 2026 is an even-numbered year, so the current renewal window opens on 1 October 2026 and closes on 31 December 2026.
A lapsed registration is one of the quieter ways a supply route breaks. Nothing announces it; the food simply becomes subject to refusal at entry. If a route runs through an Egyptian facility, that window is a diary entry worth making now.
A foreign facility must also designate a US agent for FDA communications. The agent has to be a person or entity physically located in the United States.
Ask for the facility registration and confirm when it was last renewed. A registration number on its own does not tell you whether it survived the last biennial window.
Prior notice of imported food
FDA must receive prior notice of imported food before it arrives, under 21 CFR part 1, subpart I. The notice is submitted electronically, normally through the CBP entry systems, and FDA confirms it for review.
The deadlines in 21 CFR 1.279 run to the port of arrival and vary by mode of transport: no less than 8 hours before arrival by water, 4 hours by air, 4 hours by land via rail, and 2 hours by land via road. International mail is notified before the food is sent.
There is also a ceiling on how early notice can be given — no more than 30 calendar days ahead when submitted through the CBP interface, or 15 calendar days through FDA’s own Prior Notice System Interface.
For a reefer container out of Alexandria or Damietta the 8-hour water deadline is rarely the binding constraint. What causes trouble is inaccurate data in the notice — the wrong manufacturer, an unregistered facility, or a product description that does not match the entry.
Make sure the manufacturer named in the prior notice is the facility that actually produced the lot, and that its registration is current.
FSVP — the importer’s programme, and what it asks of a supplier
The Foreign Supplier Verification Program rule sits at 21 CFR part 1, subpart L. Under 21 CFR 1.502(a) the importer must develop, maintain and follow an FSVP that provides adequate assurances that the foreign supplier is producing the food in compliance with processes and procedures providing at least the same level of public health protection as the US preventive controls or produce safety requirements, and that the food is not adulterated or misbranded with respect to allergen labeling.
The FSVP importer is the US owner or consignee of the food at entry. Where there is no US owner or consignee, a US agent or representative must be designated as the importer. The importer must be located in the United States.
At entry, 21 CFR 1.509 requires the importer’s name, electronic mail address and a unique facility identifier recognised as acceptable by FDA — in practice a DUNS number — to be provided electronically for each line entry of food offered for import.
In practice the programme runs on evidence produced by the supplier: a hazard analysis for the food, evaluation of the supplier’s performance, and verification activities that in many cases mean an annual onsite audit or an accepted equivalent. FSVP records are the thing FDA most often asks a US importer to produce, and the request usually arrives with little notice.
Ask the US importer which verification activity they intend to rely on, and what they will need from the processing site — an audit report, a food safety plan summary, or sampling and testing. Agree it before the first order rather than during an FDA records request.
Preventive controls and product standards
The substantive standard the FSVP importer verifies against is 21 CFR part 117, preventive controls for human food: a written food safety plan built on a hazard analysis, with preventive controls, monitoring, corrective actions and verification, and a supply chain programme where a hazard is controlled upstream.
Pesticide residues are handled differently from the EU. Tolerances are set by the Environmental Protection Agency in 40 CFR part 180 and enforced by FDA at import. Where no tolerance or exemption exists for a pesticide on a given commodity, any detectable residue makes the food adulterated. A substance approved in Egypt and lawful in the EU can still have no US tolerance on that crop, and that is a specific, recurring trap.
Labeling for retail packs follows 21 CFR part 101, including nutrition labeling and allergen declaration. Country of origin marking is a separate requirement again, under 19 U.S.C. 1304, administered by CBP rather than FDA.
For each active substance in the grower’s programme, check that a US tolerance exists for that specific crop. "Within EU MRL" answers a different question.
FSMA 204 traceability — the date that moved
The FSMA 204 food traceability rule adds records requirements for foods on FDA’s Food Traceability List, requiring key data elements to be captured at critical tracking events and made available to FDA on request.
The compliance date has moved. FDA published a compliance date extension in the Federal Register on 7 August 2025, shifting the date by 30 months from 20 January 2026 to 20 July 2028. The extension changed the date only, not the substance of the rule.
Whether a particular frozen product is covered turns on the Food Traceability List entry and the form of the food, and the list is amended over time. FDA maintains the list and its guidance; check the current entry for your commodity rather than assuming a frozen product is in or out.
If a buyer is already asking for FSMA 204 key data elements ahead of the compliance date, treat it as a commercial requirement and answer it on those terms.
Entry, refusal and import alerts
FDA reviews entry data and may examine a consignment. Food that appears to violate the law may be refused admission, and a refused consignment is exported or destroyed.
Where FDA has a history of violations for a product, a manufacturer or a country, it may place an entry on an import alert, which allows detention without physical examination. Consignments then need evidence of compliance before release. Import alerts are public and searchable, and checking whether one touches your product, your facility or Egypt as an origin is a short exercise worth doing before a first order rather than after a detention.
Classification for duty purposes runs on the Harmonized Tariff Schedule of the United States. Rates are not published here; the current rate for a given code is returned by the USITC tariff lookup.
Sources
Every requirement on this page is traceable to one of the instruments below. They were read on 2026-08-31. Regulations are amended — where a date or a figure matters to a decision, open the source and confirm the text in force.
- 21 CFR part 1, subpart H — registration of food facilitiesUS Government Publishing Office, eCFR
- 21 CFR part 1, subpart I — prior notice of imported foodUS Government Publishing Office, eCFR
- 21 CFR part 1, subpart L — Foreign Supplier Verification ProgramsUS Government Publishing Office, eCFR
- 21 CFR part 117 — preventive controls for human foodUS Government Publishing Office, eCFR
- 21 CFR part 101 — food labelingUS Government Publishing Office, eCFR
- 40 CFR part 180 — EPA tolerances for pesticide chemical residues in foodUS Government Publishing Office, eCFR
- FSMA final rule on requirements for additional traceability records for certain foodsUS Food and Drug Administration
- Requirements for Additional Traceability Records for Certain Foods: Compliance Date ExtensionUS Federal Register, 7 August 2025
- FDA import alertsUS Food and Drug Administration
- Harmonized Tariff Schedule of the United StatesUS International Trade Commission
- Country of origin marking — informed compliance publicationsUS Customs and Border Protection
Frequently asked questions
Who is the FSVP importer for a shipment of Egyptian frozen vegetables?
It is the US owner or consignee of the food at the time of US entry. If there is no US owner or consignee at entry, a US agent or representative must be designated as the importer. The FSVP importer must be located in the United States. An Egyptian exporter cannot be its own FSVP importer, which is why the US route requires a US-side party willing to take that role and hold the records.
Does an Egyptian factory have to be FDA registered to export frozen fruit to the US?
A facility that manufactures, processes, packs or holds food for consumption in the United States must register with FDA under 21 CFR part 1, subpart H, and that requirement applies to foreign facilities. The facility must also designate a US agent. Registration is not an FDA approval or endorsement of the site — it is a notification requirement — and food from an unregistered facility is subject to refusal.
When does FDA food facility registration have to be renewed?
Under 21 CFR 1.230 a renewal must be submitted during the period beginning 1 October and ending 31 December of each even-numbered year. The next window falls in 2026, opening 1 October and closing 31 December. A registration not renewed within its window lapses, and food from a facility whose registration is not current is subject to refusal at entry.
How far before arrival must prior notice be submitted for a reefer container?
Under 21 CFR 1.279 prior notice for arrival by water must be submitted and confirmed by FDA no less than 8 hours before arrival at the port of arrival. Air and land-by-rail are 4 hours, and land-by-road is 2 hours. Notice may not be submitted more than 30 calendar days ahead through the CBP interface, or 15 calendar days through FDA’s Prior Notice System Interface.
Is meeting EU pesticide limits enough for the US market?
No, and treating them as equivalent is a recurring cause of refusal. US tolerances are set by the EPA in 40 CFR part 180 on a substance-and-commodity basis. Where no tolerance or exemption has been established for a pesticide on that specific crop, any detectable residue renders the food adulterated, regardless of how low it is or whether it complies elsewhere. The grower programme has to be checked against the US list, crop by crop.
When does the FSMA 204 traceability rule apply?
FDA extended the compliance date by 30 months, from 20 January 2026 to 20 July 2028, in a Federal Register document published on 7 August 2025. The extension changed the date and not the requirements. Whether a specific frozen product is covered depends on the Food Traceability List entry and the form of the food, so check the current list for your commodity.
What is a unique facility identifier and why does it appear at entry?
Under 21 CFR 1.509 each line entry of food offered for import must carry the FSVP importer’s name, electronic mail address and a unique facility identifier recognised as acceptable by FDA — in practice a DUNS number. It identifies which party holds the FSVP records for that food and that supplier, which is how FDA knows whom to ask.
Products this bears on
Grade, cut and specification detail for the products most often shipped from Egypt into United States. Full range on the products page.
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