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Exporting food from the US

The FDA does not require export certificates, but importing countries often do; it issues the Certificate to a Foreign Government and the Certificate of Exportability, and keeps export lists of eligible establishments. Meat is different: carriers may not take it abroad without an FSIS export certificate. Most shipments also need an EEI filing.

Updated · Each section links to the official source it comes from

US requirement for a certificate
FDA: none; FSIS: required for meat
FDA certificate for US-legal food
Certificate to a Foreign Government
FDA certificate for export-only food
Certificate of Exportability, FD&C Act 801(e)
Establishment lists
Applied for through FDA's Export Listing Module
Meat and dairy
FSIS for meat, AMS Dairy Grading Branch for dairy
Export declaration
EEI in the AES, above $2,500 per Schedule B line

Before the goods leave

The questions to answer, in the order they usually come up.

  1. 1Does the destination ask for an export certificate, and which one? Read more
  2. 2Does it require the establishment to be on a list sent by the FDA? Read more
  3. 3Is the product meat, dairy, seafood, egg or honey, certified by another agency? Read more
  4. 4Is it made to the buyer's specification and not legal for sale in the US? Read more
  5. 5Does the shipment need EEI, and who files it? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

FDA export certificates for food

The FDA's written attestation of a product's regulatory or marketing status, issued when a buyer or foreign government asks for one.

  • The FDA does not require export certificates; foreign governments may ask for official assurance that a product can be lawfully marketed in the US.
  • The Certificate to a Foreign Government covers conventional foods, food additives, food contact substances and infant formula that meet the FD&C Act for marketing in the US.
  • The Certificate of Exportability covers the same products when they cannot be legally marketed in the US but meet section 801(e) of the FD&C Act.
  • The FDA fee schedule dated 15 September 2022 lists $175 for the first certificate, $155 for the second and $100 for each further certificate for the same products in the same request.
  • Requests go through HFP eCATS on FDA Industry Systems; labels and supporting documents should be in English or come with an English translation.
  • A certificate does not stop the FDA from taking regulatory action against the products it covers. Its standard attestation cannot be changed.

How we help: Compliant Always keeps each certificate with the shipment and lot it covers, dated, and reads it against what the destination asks for. Ask about this

Export lists of eligible establishments

Some importing authorities accept only food from establishments on public lists that the FDA sends them.

  • Establishments apply for inclusion through the FDA's Export Listing Module (ELM); criteria vary by product and destination.
  • The FDA generally sends list updates quarterly, with application deadlines of 31 March, 30 June, 30 September and 31 December.
  • Final listing decisions rest with the importing authority, and products made or shipped before official listing may be detained or rejected.
  • Listed establishments must update and resubmit their ELM application every two years or are removed.
  • Lists cover, among others, dairy for Chile, China, the EU, India and the UK, seafood, collagen and gelatin, honey and infant formula for China.

How we help: Compliant Always keeps the listing status and resubmission date with each establishment's record, and shows what is expiring before a shipment. Ask about this

Meat, dairy, seafood, eggs and honey

Products certified by agencies other than the FDA.

  • Exporters apply to FSIS for export certification of inspected and passed meat products; FSIS issues one certificate per consignment (9 CFR 322.2).
  • Containers are marked, when inspection personnel authorise it, with a mark linking the consignment to its export certificate (9 CFR 322.1).
  • No vessel is cleared and no carrier may take meat products abroad until an official export certificate has been issued, except ship stores, up to 50 pounds for the consignee's personal use, and certain exempted or inedible product (9 CFR 322.4).
  • The AMS Dairy Grading Branch certifies dairy only from plants on the IMS list, the EU dairy list or its own surveyed list, and asks for at least 5 business days.
  • NOAA's Seafood Inspection Program certifies seafood for China and the EU; the FDA issues seafood certificates for other countries.
  • USDA certifies honey exports and processed eggs and egg products, through its Specialty Crops Inspection Division and AMS.

How we help: Compliant Always keeps each agency's certificate with the consignment it names, and shows which shipments still lack one. Ask about this

Food made only for export

Section 801(e)(1) of the FD&C Act lets food that does not meet US rules be exported on conditions.

  • Food intended for export is not deemed adulterated or misbranded if it meets the foreign purchaser's specifications, does not conflict with the importing country's laws, is labelled on the outside of the shipping package as intended for export, and is not sold in domestic commerce.
  • The exporter keeps records showing each of the four conditions, such as the buyer's specification and a "For export only" shipping label (21 CFR 1.101(b)).
  • Records for food exported under section 801(e)(1) are kept for 3 years after the date of exportation and shown to the FDA on request.

How we help: Compliant Always keeps the buyer's specification, the destination evidence and the export marking with each lot, dated, ready if the FDA asks. Ask about this

Export declaration: EEI in the AES

Electronic Export Information filed in the Automated Export System, the export component of ACE, before the goods leave.

  • The EEI is filed through the AES by the US principal party in interest (USPPI), its authorised agent, or the authorised US agent of the foreign principal party in interest, for exports of physical goods, including orders received over the internet (15 CFR 30.2).
  • No EEI is needed where the value under one Schedule B or HTSUSA number, from one USPPI to one consignee on one conveyance, is $2,500 or less, unless a licence is required (15 CFR 30.37(a)).
  • Shipments to Canada are exempt, except goods stored in Canada for a third country or moving through Canada to one (15 CFR 30.36).
  • Filed before departure: 24 hours before loading for vessel cargo, 2 hours before departure for air cargo, 1 hour before a truck reaches the border (15 CFR 30.4).
  • Each line carries a 10-digit Schedule B or HTSUSA number and, where it applies, the ECCN or EAR99 (15 CFR 30.6).
  • Parties to the export keep its documents for five years from the date of export (15 CFR 30.10).

How we help: Compliant Always keeps the invoices, classifications and certificates behind each declaration with the shipment and lot, dated, and answers importers' questions from that record. Ask about this

Who answers for what

WhoWhat they answer forHow we help
ExporterMeeting the importing country's laws, applying for certificates and, as USPPI, the EEI.Certificates and declarations kept with each shipment, with gaps shown before it leaves.
ManufacturerBeing named on certificate applications, and the establishment listing where a destination needs one.Listing status, inspection reports and labels kept with the establishment's record.
Freight forwarder or customs brokerFiling EEI as the authorised agent, on the USPPI's written authorisation.The commercial documents behind the filing, in one record.
Certifying authorityThe FDA, FSIS, AMS or NOAA, depending on the product and destination.Each certificate read against what the destination asks for.

Where are the goods going?

Most of what food have to meet is set where they are sold. Each guide sets out the rules on arrival, with the official source for each.

Questions businesses ask

Do I need an export certificate to export food from the US?
For FDA-regulated food, not under US law, though the destination may ask for one. For meat products, yes: no carrier may take them abroad until an FSIS export certificate has been issued, with narrow exceptions (9 CFR 322.4).
What is an FDA Certificate to a Foreign Government?
A certificate for conventional foods, food additives, food contact substances and infant formula that meet the FD&C Act for marketing in the US. It states, among other things, that the products may be marketed in and legally exported from the US.
What is a Certificate of Exportability?
An FDA certificate for food that cannot be legally marketed in the US but meets section 801(e)(1) of the FD&C Act and may be legally exported.
How much does an FDA food export certificate cost?
For a Certificate to a Foreign Government or a Certificate of Exportability, the FDA fee schedule dated 15 September 2022 lists $175 for the first certificate, $155 for the second and $100 for each further certificate for the same products in the same request.
How long does the FDA take to issue a food export certificate?
Usually a few days, depending on the number of products, whether the application is complete and the FDA's workload. There is no expedited review; requests are processed in the order received.
Can I apply for an FDA export certificate if I am not the manufacturer?
Yes. The requestor has to identify the manufacturer of the products, and a signed letter from the manufacturer can show the link where the label does not name it.
Does the FDA issue GMP certificates for food exports?
No. The FDA's food centre does not provide written authorisation or notarise cGMP certification.
What is the FDA Export Listing Module?
The FDA system where establishments apply to be on export lists that some foreign authorities require. The FDA generally sends updates quarterly, and the importing authority makes the final listing decision.
Who issues export certificates for US meat, dairy and seafood?
FSIS for inspected meat products, the AMS Dairy Grading Branch for dairy, and NOAA's Seafood Inspection Program for seafood to China and the EU. The FDA issues seafood certificates for other destinations.
Can I export food that does not meet US rules?
Under FD&C Act section 801(e)(1), if it meets the foreign buyer's specifications, does not conflict with the destination's laws, is labelled as intended for export on the shipping package, and is not sold in the US. Records are kept for 3 years.
Do I need to file EEI to export food?
Yes, through the AES, unless an exemption applies, such as $2,500 or less under one Schedule B number to one consignee, or most shipments to Canada (15 CFR 30.36 and 30.37).
How does Compliant Always help with exporting from the US?
Our team reads the rules for the routes you ship. Compliant Always shows which export documents apply to your product, keeps them with the shipment beside what the destination asks for, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

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