What documents are required to import low-acid canned foods (LACF) into the United States?

To import LACF into the United States, the following documents must be in place: Pre-registration documents: (1) FDA Food Facility Registration confirmation with FEI number for the manufacturing facility; (2) FCE (Food Canning Establishment) registration confirmation with the FCE number; (3) SID (Scheduled Process Identifier) filings for each product-container-process combination, established before shipment; (4) Process Authority documentation supporting each SID filing; (5) U.S. Agent designation documentation for foreign facilities. Per-shipment documents: (6) FDA Prior Notice confirmation number; (7) Commercial invoice; (8) Bill of lading or air waybill; (9) Packing list; (10) Certificate of origin. Available for FDA review on request: FSVP records, HACCP plan documentation, and container coding records.

What is the Prior Notice confirmation and why is it needed for LACF imports?

FDA Prior Notice under 21 CFR Part 1 Subpart I must be filed before every LACF shipment arrives at a U.S. port — 8 hours before arrival for ocean shipments, 4 hours for air, 2 hours for road. The Prior Notice confirmation is the document or confirmation number from FDA's ESG (Electronic Submissions Gateway) confirming that the Prior Notice was received and accepted. Without a valid Prior Notice confirmation, CBP and FDA will not allow the shipment to be released. The customs broker typically handles Prior Notice filing and retains the confirmation number. The Prior Notice must include the correct FEI number for the LACF processor.

What document consistency requirements must be met for LACF imports?

All documents in an LACF import package must be internally consistent. The product description, facility name, FDA registration numbers, and container types must match across: the Prior Notice, commercial invoice, SID filing confirmation, and FDA facility registration. A common detention trigger is a name mismatch — a facility registered as 'ABC Food Processing Ltd' that ships as 'ABC Canning Company' on the commercial invoice. FDA's OASIS system cannot automatically match the facility across inconsistent names. Document consistency must be verified before every shipment to avoid triggering unnecessary detention.

What happens at the U.S. port when LACF documentation is missing or incorrect?

When FDA's OASIS system identifies a documentation issue with an LACF shipment during Prior Notice review, it triggers one of three outcomes: (1) Release with a request for additional information — the importer must respond quickly; (2) Notice of Sampling — FDA samples the product for testing (typically for commercial sterility or labeling compliance); (3) Notice of Detention — the shipment is held pending review of compliance documentation or test results. If the detention is due to missing FCE or SID filing (Import Alert 36-07), the DWPE is automatic and every subsequent shipment from the facility is also detained. Providing correct and complete documentation before the shipment departs is the most effective way to prevent these outcomes.

How far in advance should LACF documentation be prepared before a shipment?

FDA Food Facility Registration, FCE registration, and SID filings must all be completed and confirmed before the product ships — not before it arrives in the U.S. For initial shipments from a new foreign LACF supplier, the full documentation package (registration, FCE, SIDs for all products and container sizes) should be completed at minimum 4-6 weeks before the planned first shipment to allow time for FDA processing and any corrections. For ongoing shipments: the importer should verify that existing registrations and SIDs remain current before each shipment — particularly around the biennial renewal window (October–December of even years) when facility registrations lapse if not renewed.

Can an LACF shipment be released during a detention if the FCE or SID is filed after arrival?

It is possible but not reliable. FDA may in some circumstances accept corrective action — filing a missing FCE registration or SID — as grounds for releasing a detained LACF shipment, but this is not guaranteed and typically takes significant time. A missing SID for an established product from a facility that has other products with SIDs may be resolved through rapid corrective filing. A facility with no FCE registration at all is a more fundamental compliance failure that typically results in import refusal rather than a correctable detention. The far better approach is ensuring all FCE and SID filings are completed before the first export.

LACF Import Documentation Guide

Last updated: May 2026

Documents Required for Importing Low-Acid Foods into the U.S.

Q: What is the FDA Food Facility Registration document for LACF imports?

The FDA Food Facility Registration confirmation is the document proving that the manufacturing facility is registered under 21 U.S.C. 350d and 21 CFR Part 1 Subpart H. It shows the FEI (Facility Establishment Identifier) number assigned by FDA. The FEI number is a required element in the Prior Notice filing for every LACF shipment. The registration must be current — biennial renewal must have been completed during October 1 through December 31 of the most recent even-numbered year. An expired or cancelled FDA facility registration will cause OASIS to flag the Prior Notice and trigger shipment detention.

Q: What is the SID document and what does it show?

The SID (Submission Identifier) document is FDA's confirmation of a Scheduled Process filing for a specific LACF product-container-process combination under 21 CFR Part 108.25. The SID document shows: the SID number assigned by FDA; the FCE number it is associated with; the product description; the container type and size; and the processing method. A separate SID must exist for each unique product-container-size-process combination before that product can legally be exported to the United States. The SID document is the key document that FDA's OASIS system verifies against during Prior Notice processing.

Q: What is Process Authority documentation?

Process Authority documentation is the signed report or letter from a qualified Process Authority — a food scientist with specialized expertise in thermal processing — that establishes and validates the Scheduled Process for a specific LACF product. The Process Authority documentation includes: product name and description; container type and size; initial temperature range; retort processing conditions (temperature, time, come-up time, critical factors); the Process Authority's name, credentials, and signature; and a statement that the process achieves commercial sterility. This documentation supports the SID filing and may be requested by FDA to verify the scheduled process during a detention review.

Q: What information must appear on the commercial invoice for an LACF shipment?

The commercial invoice for an LACF shipment must include: seller name and address (the foreign processor/exporter); buyer name and address (the U.S. importer); product description — this must be consistent with the product description in the SID filing and the Prior Notice; the FDA facility registration number (FEI) of the manufacturer; number of cases and units; unit prices and total value; currency; country of origin; and Harmonized System (HS) codes. The product description on the commercial invoice must match the product description in the SID filing and the Prior Notice exactly — inconsistencies between documents are a common trigger for FDA detention.

Q: What FSVP documents must a U.S. LACF importer maintain?

Under 21 CFR Part 1 Subpart L, U.S. LACF importers must maintain the following FSVP documentation for each foreign LACF supplier: a written FSVP document including the hazard analysis for the foreign LACF supplier (addressing C. botulinum, inadequate thermal processing, and container integrity failure as required hazards); supplier verification activity records (periodic verification that the supplier maintains valid FCE registration and SID filings, commercial sterility testing records where appropriate, or audit documentation); corrective action records; and records of FSVP updates. FSVP records must be maintained for 2 years and must be available to FDA inspectors upon request.

Q: What is the 10-working-day window for LACF shipment detention response?

When FDA issues a Notice of Detention for an LACF shipment, the importer typically has 10 working days to respond. During this window, the importer may: provide documentation proving the shipment complies with all LACF requirements (FCE registration, SID filing, valid facility registration, and compliant labeling); arrange for reconditioning of the product if the issue is correctable; or arrange for re-exportation or destruction of the shipment. Having all LACF compliance documents organized and accessible before the shipment departs means the importer can respond to a detention within hours rather than scrambling to gather records during the 10-working-day window.

LACF import documentation falls into two categories: pre-registration documents that must exist before the first shipment ever leaves the foreign facility, and per-shipment documents needed for every shipment. The most common LACF detention trigger is not a missing label or a contaminated product — it is a documentation gap: a product shipped without a filed SID, an FEI number that doesn’t match the Prior Notice, or a facility registration that lapsed without renewal. Every document in an LACF import package must be internally consistent. When FDA detains an LACF shipment, the importer has 10 working days to respond with documentation. This guide gives you the complete checklist.

This guide covers every document required for importing LACF — pre-registration documents established before first shipment, per-shipment documents for every shipment, FSVP documentation for importers, and what to have ready if FDA detains your shipment.

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The Complete LACF Import Document Checklist

Every Document Required Before and During an LACF Shipment to the U.S.

Part 1 — Pre-Registration Documents (Must Exist Before the First Shipment — Ever)

FDA Food Facility Registration — FEI NumberThe manufacturing facility must be registered under 21 U.S.C. § 350d and 21 CFR Part 1 Subpart H. Document needed: FDA registration confirmation showing the FEI (Facility Establishment Identifier) number, facility name, and address exactly as registered. The FEI is required in the Prior Notice filing for every shipment. Must be current — biennial renewal must have been completed for the most recent even year.

FCE Registration — Food Canning Establishment NumberSeparate from the FEI, the FCE number is assigned by FDA for LACF processors under 21 CFR Part 108.25. Document needed: FCE registration confirmation from FDA showing the FCE number and the facility it is associated with. The FCE number is different from the FEI — a foreign LACF processor needs both. Missing FCE triggers automatic DWPE under Import Alert 36-07.

SID Filings — One Per Product–Container–Process CombinationA Scheduled Process Identifier must be filed with FDA for every unique combination of product formulation, container type, container size, and thermal process. Document needed: FDA SID confirmation showing the SID number, the FCE it is associated with, and the product description. Filed and confirmed before the product ships — no post-arrival cure. A 15 oz can and a 28 oz can of the same product need separate SIDs. See the SID Number Guide for full detail.

Process Authority DocumentationThe signed report or letter from the qualified Process Authority establishing and validating the Scheduled Process. Document needed: Process Authority letter or report showing: product and container description; initial temperature range; retort process conditions (temperature, time, come-up time, critical factors); the Process Authority’s name, credentials, and signature. This document supports the SID filing and may be requested by FDA during a detention review. Without Process Authority documentation, SID filings cannot be properly supported.

U.S. Agent Designation — Foreign Facilities OnlyForeign LACF facilities must designate a U.S. Agent with a physical U.S. address as part of their FDA Food Facility Registration. Document needed: Confirmation that a U.S. Agent is designated in the FDA facility registration with name and contact information. The U.S. Agent designation is part of the registration — not a separate document — but the importer should have the U.S. Agent’s contact information for FDA communication purposes. FDA Registration Assistance provides U.S. Agent services.

Part 2 — Per-Shipment Documents (Required for Every Shipment)

FDA Prior Notice ConfirmationFDA Prior Notice under 21 CFR Part 1 Subpart I must be filed before every LACF shipment arrives: 8 hours (ocean), 4 hours (air), 2 hours (road). Document needed: The Prior Notice confirmation number from FDA’s Electronic Submissions Gateway, confirming the Prior Notice was received and accepted. The customs broker typically handles filing. The Prior Notice must include the correct FEI for the LACF processor — an incorrect FEI causes OASIS to reject the Prior Notice and the shipment will be refused.

Commercial InvoiceStandard international trade document. Must include: seller and buyer names and addresses; product description consistent with the SID filing and Prior Notice; the manufacturer’s FDA FEI number; number of cases and units; unit prices and total value; currency; country of origin; Harmonized System (HS) codes. The product description must match the SID filing exactly. A name inconsistency between the commercial invoice and the FDA registration is one of the most common LACF detention triggers.

Bill of Lading / Air WaybillThe carrier’s document confirming the cargo. Used by CBP and FDA to verify the shipment against the commercial invoice and Prior Notice. The cargo description and container count must be consistent with all other shipment documents.

Packing ListDetailed listing of all items in the shipment — case counts, dimensions, weights, and lot or production codes. Must be consistent with the commercial invoice. The lot codes on the packing list should be traceable to specific production records at the LACF facility through the container coding system under 21 CFR 113.60.

Certificate of OriginDocument certifying the country where the food was manufactured. Required for U.S. customs entry and may affect duty rates under applicable trade agreements. The declared origin must be accurate and consistent with other shipment documents. If a product is declared as originating from a country that is on an FDA Import Alert for the product category, the origin documentation may trigger additional scrutiny.

Part 3 — Available on Request (Must Be Maintained — Provided During FDA Review)

FSVP DocumentationU.S. importers must maintain FSVP records under 21 CFR Part 1 Subpart L: the written FSVP including hazard analysis (C. botulinum, inadequate thermal processing, container integrity failure); supplier verification activity records; and corrective action procedures. Retained 2 years. Must be available to FDA inspectors on request.

HACCP Plan DocumentationThe foreign LACF processor’s seafood or LACF HACCP plan documentation. As part of FSVP supplier verification, the importer should have documentation from the foreign processor confirming their HACCP program exists. May be requested by FDA during a detention review or FSVP inspection.

Container Coding RecordsUnder 21 CFR 113.60, each LACF container must bear a permanent code identifying the establishment, product, year, day, and production period. The processor must maintain records of the container code system. If FDA detains a shipment and conducts a production records review, the processor must be able to demonstrate that the containers’ codes correspond to specific production records showing SID compliance.

The 10-Working-Day Detention Response Window

What Happens When FDA Detains Your LACF Shipment

FDA Detention Response Window for LACF Shipments

Working Days to Respond to a Notice of Detention

When FDA issues a Notice of Detention, the importer has approximately 10 working days to: provide documentation proving the shipment complies with all LACF requirements (FCE, SID, valid facility registration, compliant labeling); arrange for reconditioning if the issue is correctable; or arrange for re-exportation or destruction. Having all documents organized before the shipment departs means the importer can respond within hours instead of scrambling to gather records. For Import Alert 36-07 detentions (missing FCE/SID), post-arrival documentation filing is possible but not guaranteed to achieve release — completing filings before export is always the correct approach.

Most Common LACF Documentation Detention Triggers

✗ No SID filed for the specific product and container being shipped

✗ FEI number in Prior Notice doesn’t match the actual registered facility name

✗ Facility registration expired at biennial renewal, Prior Notice rejected by OASIS

✗ Product description on commercial invoice inconsistent with SID product description

✗ New container size added but no new SID filed for that size

✗ Retort pouch product — customs broker used wrong FDA product code in Prior Notice

How to Prevent Documentation Detentions

✓ Maintain a documentation file for each foreign LACF supplier with current FEI and FCE numbers

✓ Verify all SIDs are filed for every product and container size before each shipment

✓ Confirm biennial renewal is current before October–December renewal window

✓ Brief customs broker on correct FEI number and LACF product codes

✓ Verify product description consistency between commercial invoice, Prior Notice, and SID filing

✓ Maintain FSVP records for 2 years and keep them accessible

Document Consistency — The Most Overlooked Requirement

Why Document Consistency Across the LACF Import Package Is Critical

⚠ The most common LACF documentation problem is not a missing document — it is inconsistency between documents. FDA’s OASIS system tries to match the Prior Notice FEI against the FDA facility registration database. If the facility is registered as “ABC Food Processing Ltd” but ships as “ABC Canning Company” on the commercial invoice, OASIS cannot confirm the match. Every document in the LACF import package must use the same facility name, FEI number, and product description.

Facility Name Consistency

The facility name used in the Prior Notice, commercial invoice, and bill of lading must match the facility name exactly as registered in FDA’s facility registration database (FEI). Abbreviations, trading names, DBA names, and parent company names all create potential mismatches. Use the facility name exactly as it appears in the FDA registration.

Product Description Consistency

The product description in the Prior Notice and commercial invoice must be consistent with the product description in the SID filing. “Canned Kidney Beans in Brine, 15 oz” and “Kidney Beans (canned)” on different documents can trigger a question about whether the correct SID covers the product being shipped. Use the same product description across all documents.

Container Type and Size Consistency

The container type and size in the Prior Notice must match the SID filing for that container type and size. A SID for “425g (15 oz) metal can” does not cover a “400g retort pouch” of the same product. The customs broker must use the correct container-specific product code in the Prior Notice. Each container size requires its own SID.

Complete LACF Import Documentation Support

Need Help Getting Your LACF Documentation in Order?

FDA Registration Assistance provides complete LACF import documentation support: FDA Food Facility Registration and U.S. Agent services for foreign LACF processors; FCE registration coordination; Process Authority coordination and SID filing submission; FSVP programs for U.S. LACF importers; Prior Notice accuracy review; document consistency review before shipments; and import detention response support during the 10-working-day window. 1,000+ clients. 135+ countries. 15+ years of FDA regulatory experience.

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FAQ

Frequently Asked Questions — Documents Required for Importing Low-Acid Foods

1. What documents are required to import LACF into the United States?

Pre-registration (established before first shipment): FDA Food Facility Registration (FEI number); FCE registration (FCE number); SID filings for each product–container–process combination; Process Authority documentation; U.S. Agent designation for foreign facilities. Per-shipment: Prior Notice confirmation; commercial invoice; bill of lading; packing list; certificate of origin. On request: FSVP records, HACCP plan documentation, container coding records.

2. What is the FDA Food Facility Registration document for LACF imports?

The FDA Food Facility Registration confirmation showing the FEI (Facility Establishment Identifier) number assigned to the manufacturing facility. The FEI is required in every Prior Notice filing. Must be current — biennial renewal (October–December of even years) must have been completed. An expired FEI causes OASIS to flag the Prior Notice and trigger detention.

3. What is the FCE number and how is it different from the FDA FEI?

The FCE (Food Canning Establishment) number is a separate identifier assigned by FDA for LACF processors under 21 CFR Part 108. It is different from the FEI from the standard food facility registration. A foreign LACF processor needs both an FEI (from food facility registration) and an FCE number (from the separate LACF FCE registration). Missing FCE triggers automatic DWPE under Import Alert 36-07.

4. What is the SID document and what does it show?

The SID (Submission Identifier) is FDA’s confirmation of a Scheduled Process filing for a specific LACF product–container–process combination under 21 CFR Part 108.25. Shows: SID number; FCE number; product description; container type and size; processing method. A separate SID must exist for every unique product–container–size combination before shipment. See the SID Number Guide.

5. What is Process Authority documentation?

The signed report or letter from the qualified Process Authority establishing the Scheduled Process. Includes: product and container description; initial temperature range; retort conditions (temperature, time, come-up time); the Process Authority’s name, credentials, and signature. Supports the SID filing and may be requested by FDA during a detention review.

6. What information must appear on the commercial invoice for an LACF shipment?

Seller and buyer names and addresses; product description consistent with the SID filing and Prior Notice; manufacturer’s FDA FEI number; number of cases and units; unit prices and total value; currency; country of origin; HS codes. Product description must match the SID filing exactly — inconsistencies are a common LACF detention trigger.

7. What is the Prior Notice confirmation for LACF imports?

The confirmation number from FDA’s Electronic Submissions Gateway confirming the Prior Notice was received and accepted. Filed by the customs broker. Must include the correct FEI for the LACF processor. Filed: 8 hours before arrival (ocean), 4 hours (air), 2 hours (road). An incorrect FEI causes OASIS to reject the Prior Notice.

8. What FSVP documents must a U.S. LACF importer maintain?

Under 21 CFR Part 1 Subpart L: written FSVP with hazard analysis (C. botulinum, inadequate thermal processing, container integrity failure); supplier verification activity records (FCE/SID verification, commercial sterility testing); corrective action records; and FSVP update records. Maintained for 2 years. Available to FDA inspectors on request.

9. What is the 10-working-day window for LACF shipment detention response?

When FDA issues a Notice of Detention, the importer has approximately 10 working days to: provide documentation proving compliance; arrange for reconditioning; or arrange re-exportation or destruction. Having all LACF compliance documents organized before the shipment departs means the importer can respond within hours rather than days.

10. What document consistency requirements must be met?

All documents must use the same facility name (exactly as in FDA registration), FEI number, and product description. A name mismatch between the commercial invoice and the FDA facility registration is one of the most common LACF detention triggers. OASIS cannot automatically match a facility across inconsistent names.

11. Do customs brokers handle LACF documentation?

Customs brokers handle Prior Notice filing, CBP entry filing, and coordination with FDA for detained shipments. They do not manage regulatory compliance documents — FDA registration, FCE registration, SID filings, Process Authority documentation, and FSVP records are the importer’s and manufacturer’s responsibility. The customs broker needs the correct FEI number from the compliance documentation.

12. What happens when LACF documentation is missing or incorrect at the port?

OASIS identifies the issue and triggers one of three outcomes: release with request for additional information; Notice of Sampling (FDA samples for testing); or Notice of Detention (shipment held). For Import Alert 36-07 (missing FCE/SID), DWPE is automatic — every subsequent shipment from the facility is also detained until the underlying compliance issue is corrected.

13. What is OASIS and how does it screen LACF shipments?

OASIS (Operational and Administrative System for Import Support) is FDA’s electronic import screening system. When a Prior Notice is filed, OASIS automatically checks: FDA facility registration database (FEI valid and current); Import Alert list (facility on DWPE?); and FCE/SID database (valid FCE and SID on file for this facility and product?). Screening is instantaneous at Prior Notice filing time.

14. Must all LACF documents be in English?

FDA electronic filings (Prior Notice, facility registration, FCE, SID) are in English. Commercial invoice, bill of lading, and packing list are typically in English for CBP customs entry. Process Authority documentation and FSVP records should be available in English (or with English translation) for rapid FDA review during the 10-working-day detention response window.

15. Does the certificate of origin affect LACF import screening?

Not directly for FDA’s LACF screening — OASIS focuses on the FEI, FCE/SID, and Import Alert status. However, if a product is declared as originating from Country A but FDA has intelligence suggesting it was actually processed in Country B on an Import Alert, the origin documentation may trigger additional scrutiny. Accurate origin declarations consistent with other documents are essential.

16. How should an LACF importer organize their documentation before each shipment?

Maintain a documentation file for each foreign LACF supplier: current FEI and FCE numbers; SID confirmations for each product and container size; Process Authority documentation; U.S. Agent contact information; FSVP documentation; and template commercial invoice with correct product descriptions and FEI. Before each shipment: verify FEI registration is current; confirm SID is filed for the specific product and container being shipped; confirm the customs broker has the correct FEI for the Prior Notice.

17. What is the FSVP hazard analysis document for LACF imports?

The written FSVP hazard analysis prepared by the U.S. LACF importer under 21 CFR Part 1 Subpart L identifying significant hazards for the foreign LACF supplier’s products. Must address: C. botulinum (primary biological hazard — commercial sterility verification through SID); inadequate thermal processing (process control hazard — verified through SID and Process Authority); and container integrity failure (physical hazard). Determines the appropriate supplier verification activities.

18. What documents are needed specifically for retort pouch LACF imports?

Same documentation as metal can LACF: FEI, FCE, SID for the specific retort pouch product–process combination (retort pouches need their own SIDs separate from any metal can SIDs), Process Authority documentation for the retort pouch scheduled process, Prior Notice with correct FEI and product codes for retort-pouched LACF. Ensure the customs broker uses the correct FDA product codes for retort-pouched LACF in the Prior Notice.

19. How far in advance should LACF documentation be prepared?

FDA registration, FCE, and SID filings must be completed and confirmed before the product ships. For initial shipments from a new foreign supplier: complete all documentation at least 4–6 weeks before the planned first shipment. For ongoing shipments: verify before each shipment that existing registrations and SIDs remain current — particularly around the biennial renewal window (October–December of even years).

20. What LACF documents must a customs broker receive from the importer?

The manufacturer’s FDA FEI number (for Prior Notice); product description matching the SID filing; commercial invoice, bill of lading, and packing list; certificate of origin; and correct FDA product codes for the LACF product category. The customs broker does not manage FCE/SID compliance documentation — those are the importer’s responsibility to maintain separately.

21. What is a Notice of Detention for an LACF shipment?

FDA’s official written notice that a shipment is being detained pending review. Initiates the 10-working-day response window. For LACF: most commonly issued because the Prior Notice FEI is not current; OASIS could not find a valid FCE/SID for the facility and product; FDA sampling detected a contamination issue; or labeling compliance issues were identified.

22. Can an LACF shipment be released if FCE or SID is filed after arrival?

Possible but not reliable. For an established product from a facility with other valid SIDs, rapid corrective filing may allow release. For a facility with no FCE registration at all, the compliance failure is more fundamental and typically results in import refusal. The correct approach is completing all FCE and SID filings before the first export.

23. What container coding documentation is required for LACF?

Under 21 CFR 113.60, each LACF container must bear a permanent code identifying the establishment, product, year, day, and production period. The processor must maintain records of the container code system. If FDA detains a shipment and conducts a production records review, the processor must demonstrate that containers’ codes correspond to production records showing SID compliance.

24. How does FDA Registration Assistance help with LACF import documentation?

Food Facility Registration and U.S. Agent services; FCE registration coordination; Process Authority coordination and SID filing submission; FSVP programs for U.S. LACF importers; Prior Notice accuracy review; document consistency review; and detention response support. 1,000+ clients. 135+ countries.

25. How do I get started with LACF import documentation compliance?

Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Provide your facility name and address, LACF products you manufacture or export, container types and sizes, current FDA registration and FCE numbers if applicable, and any existing SID information. FDA Registration Assistance will assess your documentation status, identify gaps, and complete all required filings before your first or next LACF shipment.

Reviewed By Hector Matos, Senior Regulatory Compliance Specialist · 15+ years FDA compliance experience · Published May 2026