U.S. FDA Process Filing for Overseas Food Facilities
This guide explains the difference between Food Facility Registration, FCE registration, and SID process filing, who needs process filing, the Process Authority requirement, Import Alert 36-07, and exactly what each step costs.
What Each Step Costs — And Exactly What $858 Does and Doesn’t Cover
Food Facility Registration vs. FCE vs. SID — They Are Not the Same
There Is No Post-Arrival Cure for a Missing Process Filing
The SID must be on record before the product is exported. You cannot file it after the shipment arrives to release that shipment.
FDA’s OASIS system automatically screens every shipment of low-acid canned and acidified food for a valid FCE and SID. A shipment from a facility without them is detained at the port — and the filing cannot be applied retroactively to rescue that shipment. Repeated violations can land your facility on Import Alert 36-07, which triggers automatic detention of every future shipment. This is why process filing is one of the most time-sensitive FDA requirements: the work has to be done well before your first U.S. shipment, not in response to a problem.
What Counts as a Low-Acid Canned Food?
Under 21 CFR Part 113: pH above 4.6 AND water activity above 0.85, in a hermetically sealed container, thermally processed. Canned vegetables, beans, soups, meats, seafood, coconut milk, ready-to-eat meals. The primary hazard is Clostridium botulinum. See the full LACF import requirements →
It’s Not Only Metal Cans
A frequent misconception: “canned” means metal cans only. The LACF and acidified food rules apply to any hermetically sealed container — glass jars, retort pouches, plastic cups and tubs. If the food is low-acid, hermetically sealed, and thermally processed, it needs FCE and SID regardless of container material.
What We Do — And What You Supply
✓ What FDA Registration Assistance Handles
• FDA Food Facility Registration ($858)
• U.S. Agent designation and ongoing service
• FCE registration on Form FDA 2541
• SID scheduled process filing (Form 2541d / 2541e)
• Biennial Renewal management
• A single point of contact for the full filing stack
→ What the Client Supplies
• Process Authority documentation establishing the scheduled process (validated time/temperature for LACF, or acidification process for acidified foods)
The Process Authority determination is the client’s responsibility. We do not provide or coordinate it. Once you supply the scheduled process, we complete the FCE and SID filings.
Ready to File Your FCE and SID Before Your First Shipment?
FDA Registration Assistance handles the complete FDA filing stack for overseas low-acid canned and acidified food facilities: Food Facility Registration ($858, including U.S. Agent and Biennial Renewal), FCE registration plus first SID ($1,250), and each additional SID ($950). The Process Authority documentation establishing your scheduled process is supplied by you; we handle everything else. Get it done before your first shipment — there is no post-arrival cure. 1,000+ clients. 135+ countries. 15+ years of FDA regulatory experience.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333.
Frequently Asked Questions — FDA Process Filing for Overseas Facilities
1. What is FDA process filing for overseas food facilities?
The submission of scheduled process information to FDA for low-acid canned foods (LACF) and acidified foods. It consists of FCE (Food Canning Establishment) registration on Form FDA 2541 and SID (Submission Identifier) process filing on Form FDA 2541d (LACF) or 2541e (acidified). Process filing is separate from and in addition to standard Food Facility Registration. An overseas canned/acidified food facility needs all three.
2. How much does FDA process filing cost?
Food Facility Registration is $858 (including U.S. Agent and Biennial Renewal). FCE registration plus first SID is $1,250. Each additional SID is $950. FDA charges $0 for the registration itself. DUNS fees are separate. The $858 is the baseline; FCE and SID apply only to LACF and acidified food facilities. The Process Authority documentation must be supplied by the client.
3. What is the difference between Food Facility Registration, FCE registration, and SID filing?
Three separate requirements. Food Facility Registration (21 CFR Part 1 Subpart H) identifies the facility — required for all food facilities, renewed biennially. FCE registration (Form FDA 2541) registers the canning establishment for LACF/acidified production. SID filing (Form 2541d/2541e) files the scheduled process for each product/container/process combination. One Food Facility Registration and one FCE per facility, but potentially many SIDs.
4. What is FCE registration and what form is used?
FCE (Food Canning Establishment) registration identifies a facility processing LACF or acidified foods. Submitted on Form FDA 2541, producing an FCE number. Required under 21 CFR Part 108. The FCE number is distinct from the FDA registration number and the FEI — three different identifiers. Must be completed before canned/acidified products can be legally distributed in the U.S.
5. What is a SID and what is a scheduled process?
A SID (Submission Identifier) is the identifier for a scheduled process filing. A scheduled process is the specific thermal process (time, temperature, critical factors) established by a Process Authority to destroy Clostridium botulinum in LACF, or the acidification process for acidified foods. Filed on Form 2541d (LACF) or 2541e (acidified). A separate SID is needed for each product/container/process combination.
6. What is a low-acid canned food (LACF)?
Under 21 CFR Part 113: a food with pH above 4.6 AND water activity above 0.85, in a hermetically sealed container, thermally processed to commercial sterility. Canned vegetables, meats, fish, soups, beans, coconut milk, ready-to-eat meals. Hermetically sealed containers include metal cans, glass jars, retort pouches, and plastic containers. The primary hazard is Clostridium botulinum.
7. What is an acidified food?
Under 21 CFR Part 114: a low-acid food to which acid is added to bring the finished equilibrium pH to 4.6 or below, with water activity above 0.85. Pickles, pickled vegetables, some sauces and salsas, marinated products. Requires a SID on Form 2541e and a scheduled process validated by a Process Authority. Improperly acidified foods present the same botulism risk as LACF.
8. Why must the SID be filed before the product is exported?
The SID must be on record before distribution in the U.S. There is no post-arrival cure — a shipment from a facility without a valid FCE and SID is detained, and the filing cannot be applied retroactively to that shipment. OASIS automatically checks each shipment. This makes process filing one of the most time-sensitive FDA requirements: file well before the first shipment.
9. What is the Process Authority and do you provide it?
A Process Authority is a person or organization with expert knowledge who establishes the validated scheduled process for an LACF or acidified food. FDA Registration Assistance does NOT provide or coordinate the Process Authority. The Process Authority documentation establishing the scheduled process must be supplied to us by the client. We then handle the FCE registration and SID filing using that scheduled process. Obtaining the Process Authority determination is the client’s responsibility.
10. Which food products require FDA process filing?
LACF (pH above 4.6, water activity above 0.85, hermetically sealed, thermally processed — 21 CFR Part 113) and acidified foods (acidified to pH 4.6 or below — 21 CFR Part 114). Examples: canned vegetables, beans, soups, meats, seafood, coconut milk, pickles, salsas, marinated products. Naturally acidic foods, non-hermetically-sealed foods, and non-shelf-stable refrigerated foods generally do not — evaluate each product individually.
11. What is the difference between the FCE number, the FDA registration number, and the FEI number?
Three different identifiers. The FDA Food Facility Registration number is assigned at registration (21 CFR Part 1 Subpart H). The FCE number is assigned at canning establishment registration (Form 2541). The FEI (FDA Establishment Identifier) tracks establishments across FDA systems. A canned-food facility may hold all three. Confusing them, or assuming one satisfies another, is a common mistake.
12. What is Import Alert 36-07?
Import Alert 36-07 covers LACF and acidified foods offered for import without the required FCE and SID, or otherwise violating the LACF/acidified rules. A facility can be placed on it, resulting in Detention Without Physical Examination — every subsequent shipment automatically detained. Because there is no post-arrival cure and Import Alert placement affects all future shipments, filing correctly before the first export is essential.
13. Does an overseas LACF facility also need standard FDA Food Facility Registration?
Yes. Food Facility Registration is required for all food facilities — the baseline that identifies the facility to FDA, renewed biennially. On top of it, an LACF or acidified food facility must complete FCE registration and SID filing. The registration alone does not allow export of canned/acidified foods. We provide Food Facility Registration for $858 and FCE plus first SID for $1,250.
14. Do overseas process filing facilities need a U.S. Agent?
Yes. Foreign food facilities must designate a U.S. Agent with a physical U.S. address as part of Food Facility Registration (21 CFR Part 1 Subpart H). The U.S. Agent receives FDA communications for the facility. U.S. Agent designation is included in the $858 Food Facility Registration service.
15. How many SID filings does a facility need?
One per distinct product / container type and size / processing method combination. A facility producing canned beans in two sizes and canned soup in one size needs three SIDs. The first SID is in the $1,250 FCE plus first SID; each additional SID is $950. The number depends on how many distinct product/container/process combinations you export.
16. What records must LACF facilities maintain?
Under 21 CFR Part 113, processing and production records showing each lot was processed to the scheduled process — thermal data, container closure examinations (21 CFR 113.60), deviation records. Retained 3 years (shelf-stable) / 2 years (refrigerated) under 21 CFR 113.100. Available for FDA review. Part of demonstrating compliance with the filed scheduled process.
17. What is container coding and why does it matter for LACF?
Under 21 CFR 113.60, each hermetically sealed LACF container must be permanently marked with an identifying code (establishment, product, year, day, processing period). Coding enables traceability and recall if a deviation or contamination is found. Examined during FDA inspections. Improper coding is a violation even if FCE and SID are otherwise correct.
18. What happens if a shipment arrives without a valid FCE and SID?
It is detained. OASIS screens each shipment against the FCE/SID database. There is no post-arrival cure — you cannot file after arrival to release that shipment. It may be refused entry, with significant loss for time-sensitive products. Repeated violations can lead to Import Alert 36-07.
19. Is process filing required for foods in glass jars or pouches, not metal cans?
Yes. The rules apply to any hermetically sealed container — glass jars, retort pouches, plastic cups and tubs — not only metal cans. A common misconception is that “canned” means metal only. If the food is low-acid (pH above 4.6, water activity above 0.85), hermetically sealed, and thermally processed, it needs FCE and SID regardless of container material.
20. What FSVP hazards apply to imported low-acid canned foods?
U.S. importers must address in their FSVP (21 CFR Part 1 Subpart L): Clostridium botulinum from inadequate thermal processing (primary); container integrity failures; and inadequate acidification. Verification should confirm the facility has a valid FCE and SID, follows the scheduled process, maintains records, and performs container closure examinations.
21. How long does FDA process filing take to complete?
Once you supply the Process Authority documentation, we can complete the FCE registration and SID filing relatively quickly. The longest part for most facilities is obtaining the Process Authority determination — the client’s responsibility, which can take time depending on the product and testing schedule. Because there is no post-arrival cure, begin well in advance of your first U.S. shipment.
22. What does the $858 Food Facility Registration include for an LACF facility?
Registration under 21 CFR Part 1 Subpart H; U.S. Agent designation; activity code and product category selection; FURLS submission; and Biennial Renewal management. FDA charges $0. DUNS fees separate. The $858 covers the baseline registration only — it does NOT include the FCE registration or SID filing, which are the separate $1,250 (FCE plus first SID) and $950 (each additional SID) services.
23. Can FDA Registration Assistance handle the full process filing stack?
Yes — with the Process Authority supplied by you. We handle Food Facility Registration ($858, including U.S. Agent and Biennial Renewal), FCE plus first SID ($1,250), and each additional SID ($950). The one component we do not provide is the Process Authority determination — that documentation must be supplied to us. Once we have the scheduled process, we complete the FCE and SID filings. A single point of contact for the filing work, with the Process Authority responsibility clearly with the client.
24. What are the most common process filing mistakes for overseas facilities?
Assuming Food Facility Registration alone allows canned food export; waiting until a shipment is ready (or detained) to file the SID (no post-arrival cure); assuming only metal cans require filing; not obtaining a Process Authority determination first; confusing the FCE number with the registration number; filing one SID and assuming it covers all products; and not maintaining processing records under 21 CFR Part 113. See also our common registration mistakes guide.
25. How do I get started with FDA process filing for my overseas facility?
Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Provide your facility name and address, the canned or acidified products you export and their container types/sizes, whether you have Process Authority documentation, and any existing registration or FCE information. We complete the Food Facility Registration ($858), FCE plus first SID ($1,250), and additional SIDs ($950 each). Process Authority documentation is supplied by you. DUNS fees separate.
