FCE Registration & SID Process Filing
FCE Registration & SID Process Filing is the U.S. FDA compliance program that requires every commercial processor of low-acid canned foods (LACF) and acidified foods packaged in hermetically sealed containers to register the establishment (FCE) and file a scheduled process (SID) for each product before it can be sold in U.S. commerce. The requirement is established under 21 CFR Part 108 and operationalized by 21 CFR Part 113 (thermally processed LACF) and 21 CFR Part 114 (acidified foods). It assigns FDA a unique FCE number to your facility and a unique SID number to every product/container/process combination, allowing FDA to verify that your thermal process or acidification step prevents Clostridium botulinum growth. Without active FCE and SID filings, FDA can detain product at the U.S. border, refuse imports, issue Warning Letters, and place your facility on Import Alert 99-26 for Detention Without Physical Examination (DWPE) — effectively blocking your products from the U.S. market.
Federal regulations under 21 CFR Part 108 require commercial processors of low-acid canned foods (LACF) and acidified foods to register each establishment and file scheduled processes with the FDA. FDA Registration Assistance handles your FCE registration and SID filings — ensuring full compliance and protecting your U.S. market access.
Includes FCE registration + 1 SID filing — additional SIDs priced separately
What Is FCE Registration & Why Does Your Facility Need It?
Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the FDA requires Prior Notice for all food and animal feed imported or offered for import into the United States. Prior Notice — also known as Advance Notice of Imported Food — is an electronic submission that gives the FDA detailed shipment information before the goods arrive at a U.S. port of entry.
The FDA works in coordination with U.S. Customs and Border Protection (CBP) to review Prior Notices, target inspections, and protect the U.S. food supply. Missing or inaccurate filings can result in shipment detention, refusals, and costly port delays. FDA Registration Assistance files Prior Notices on your behalf — accurately and on time.
- FDA Food Facility Registration (FFR)
- Food Canning Establishment (FCE) registration
- Ensure filings meet all FDA-specified timeframe requirements
- Reduce risk of shipment delays, detentions, and enforcement actions
FCE Registration & SID Process Filing — Who Must Comply & What Is Required
Prior Notice is mandatory for virtually all food and animal feed imports entering the United States. Understanding who must file, when, and what information is required is critical to keeping your shipments moving.
Who Must Register as an FCE
Prior Notice is required for all food and animal feed products imported or offered for import into the United States, regardless of transportation mode.
- Foreign food manufacturers & exporters
- U.S. food importers & brokers
- Logistics providers handling food shipments
- All transport modes: air, ocean, truck, rail & mail
What LACF & Acidified Foods Qualify
Each Prior Notice submission must provide the FDA with accurate and complete details about the incoming shipment before it arrives at a U.S. port of entry.
- LACF: finished pH > 4.6, water activity > 0.85
- Acidified foods: pH ≤ 4.6, water activity > 0.85
- Hermetically sealed containers (cans, jars, pouches)
- Excludes alcohol, tomatoes with pH ≤ 4.7
SID Process Filing Requirements
Prior Notice must be submitted before the shipment departs for the United States. FDA-specified timeframes vary by mode of transportation.
- Separate filing for each product & formulation
- Ocean freight: at least 8 hours before arrival
- Road (truck/rail): at least 2 hours before arrival
- Mail / international mail: before shipment departs
Consequences of Non-Compliance
Failing to submit Prior Notice correctly or on time can result in immediate FDA action at the port of entry, creating costly delays and enforcement exposure.
- FDA product detention or refusal at port
- Import Alert issuance (DWPE)
- FDA enforcement & warning letters
- Inability to sell products in the U.S.
Trusted FCE & SID Compliance Partner
We have helped food manufacturers, processors, and exporters across 135+ countries achieve and maintain FDA FCE registration and SID process filing compliance — keeping products on the U.S. market without interruption.
How Our FCE Registration & SID Filing Service Works
A straightforward four-step process to get your establishment registered and all scheduled processes filed with the FDA.
Submit Facility Details
Provide your establishment information, product details, container types, and scheduled process documentation for our review.
FCE Registration Filed
Our FDA compliance experts review all shipment and facility information to ensure the Prior Notice will be accurate and complete before submission.
SID Process Filings Submitted
We submit your Prior Notice electronically through the FDA Prior Notice System Interface (PNSI), well within the required timeframes.
Compliance Confirmed
You receive the FDA Prior Notice confirmation number, which must accompany your shipment to the port of entry. Your shipment is ready to move.
What an FCE-Registered Processor Must Do Under U.S. Federal Law
Registering once is not enough. Federal regulations impose continuous duties on every FCE-registered facility — from product launch through every batch produced, every change made, and every record retained.
Register the Establishment Before Commercial Production
Under 21 CFR 108.25(c)(1) and 108.35(c)(1), the FCE must be filed via FDA Form 2541 before any LACF or acidified product enters U.S. commerce — registering after a shipment is detained is not acceptable.
File a Separate SID for Every Product & Container
A unique scheduled process must be filed for each product, each formulation, each container size and shape, and each processing method. Reusing one SID across multiple products is a top cause of FDA enforcement action.
Engage a Qualified Process Authority
Per 21 CFR 113.83 and 114.83, scheduled processes must be established and signed by a recognized Process Authority with documented expertise in thermal processing or acidification — typically through a university or independent expert lab.
Maintain a Better Process Control School Supervisor
21 CFR 113.10 and 114.10 require that every shift operating retorts or acidification equipment be supervised by an individual who has completed an FDA-recognized Better Process Control School (BPCS) within the last several years.
Keep Processing & Production Records for 3+ Years
Per 21 CFR 113.100 and 114.100, time-temperature charts, pH logs, container-closure records, deviation logs, and process-authority letters must be retained at the facility for at least three years and produced on demand during FDA inspection.
Report Process Deviations Promptly
21 CFR 113.89 and 114.89 require that any deviation from the filed scheduled process be evaluated by a competent processing authority and that affected product be segregated, reprocessed, or destroyed — with records made available to FDA.
Update FCE Information After Any Change
Changes to facility name, ownership, address, commercial status, or product line must be filed as an FCE amendment. New products or container changes always require additional SID filings before that product can be shipped.
Maintain Linked FDA Food Facility Registration
FCE is dependent on an active biennial FFR under 21 CFR Part 1, Subpart H. If the FFR expires or is suspended, the linked FCE is treated as inactive — and every shipment from that facility becomes refusable at U.S. ports.
FCE Registration vs FDA Food Facility Registration (FFR) — Two Separate Requirements
The FCE registration and the FDA Food Facility Registration (FFR) are routinely confused — but they are distinct programs under different parts of Title 21 and answer different regulatory questions.
| FCE Registration | FDA Food Facility Registration (FFR) | |
|---|---|---|
| Who Designates It | FDA Center for Food Safety and Applied Nutrition (CFSAN) — LACF Registration Coordinator. | FDA via the Food Facility Registration Module (FFRM) on Industry Systems. |
| Who It Represents | One physical canning/acidification establishment plus every scheduled process performed there. | Any facility that manufactures, processes, packs, or holds food for U.S. consumption. |
| Required By | 21 CFR 108.25 (acidified) and 108.35 (LACF). | 21 CFR Part 1, Subpart H (FFR) — under FSMA / Bioterrorism Act. |
| Governing Regulation | 21 CFR Parts 108, 113 & 114. | 21 U.S.C. § 350d and 21 CFR §§ 1.225–1.243. |
| Primary Function | Verifies the safety of the thermal/acidification process for each specific product. | Allows FDA to identify, contact, and inspect all facilities supplying U.S. food. |
| Required For | LACF and acidified foods in hermetically sealed containers — domestic and foreign. | All food facilities serving U.S. market, regardless of product category — must be renewed every even year. |
FCE and FFR are not interchangeable. An FFR alone does not authorize you to manufacture LACF or acidified foods — and an FCE without an active linked FFR is treated by FDA as inactive. Virtually every commercial canner or acidified-food processor exporting to or operating in the United States needs both, and the data (legal name, physical address, owner/operator) must match exactly between the two records or FDA's system will flag the FCE as orphaned. FDA Registration Assistance can bundle both registrations and keep them synchronized year over year.
Self-Filing FCE & SID vs Using a Dedicated Compliance Service
FDA Industry Systems is technically free to use, but the program assumes the filer has deep knowledge of thermal processing, acidification, container codes, and FDA validation logic. Here is what the two paths actually look like.
| Self-Filing (DIY) | Recommended FDA Registration Assistance | |
|---|---|---|
| Cost | $0 FDA fee + dozens of staff hours + Process Authority retainer. | $1,250 / year — FCE registration + 1 SID filing, additional SIDs priced separately. |
| Availability | Limited to your in-house regulatory team's schedule and Industry Systems learning curve. | Dedicated compliance team, 24–48 hour turnaround, ongoing support throughout the registration year. |
| Domain Expertise | You must self-learn 21 CFR 108/113/114, container codes, pH/aw validation, and FDA form logic. | 15+ years specifically handling LACF and acidified food FCE/SID filings across 135+ countries. |
| Risk of Failure | High — common errors include FFR/FCE mismatch, missing Process Authority signature, wrong container code, incorrect process method. | Low — pre-submission validation, FFR linkage check, and Process Authority document review before any filing is sent. |
| Confirmation & Handling | You monitor your own portal, troubleshoot rejections, and chase FDA LACF coordinators yourself. | We track every filing in our system, resolve FDA validation errors at no extra charge, and deliver confirmation numbers directly. |
| Renewal & Update Tracking | Manual — easy to miss biennial FFR renewal, ownership changes, or product-line additions. | Proactive reminders for FFR biennial renewal, ownership transfers, new SID needs, and process changes. |
Most commercial canners and acidified-food processors choose a dedicated service because the cost of one rejected SID, one detained shipment, or one FDA Warning Letter dwarfs the annual service fee. FDA Registration Assistance handles the regulatory side end-to-end so your operations team can stay focused on production, quality, and growth.
Using a Friend or Free Contact to File vs a Professional Service
FDA does not charge a government fee for FCE registration or SID filings — which leads some founders to ask a friend or unrelated contact to file. Here is the honest trade-off.
| Friend / Free Contact | Recommended FDA Registration Assistance | |
|---|---|---|
| Government Fee | $0 — FDA charges no fee for FCE or SID filings. | $0 government fee + $1,250 / year professional service (FCE + 1 SID). |
| Pros | No service cost; familiar relationship; quick to start. | Expert filings, validated documentation, FDA correspondence handled, error-free submissions, audit-ready records. |
| Cons | No accountability if FDA rejects; no Process Authority validation; no liability coverage; risk of Class I recall from a bad SID; possible deactivation of FCE. | A predictable annual fee — offset by zero detentions, zero refused shipments, and ongoing compliance support. |
| Best For | No one operating a commercial canning or acidified-food business — the regulatory exposure outweighs the savings. | Any domestic or foreign manufacturer, co-packer, importer, or brand selling LACF/acidified foods into the U.S. |
The real cost of the "free friend" option is not the filing — it is the first detained container, the first Warning Letter, or the first Class I recall caused by an incorrectly filed scheduled process. A professional service makes the small annual cost predictable and the regulatory outcome reliable.
Key FCE & SID Terms Every Processor Should Know
FCE and SID filings use precise regulatory vocabulary. Misusing any of these terms in a submission is a common rejection trigger.
Why FCE & SID Filings Fail — and How to Avoid It
Most FDA enforcement actions against canners and acidified-food processors trace back to a small number of repeat mistakes. Understanding them up front is the cheapest form of compliance insurance.
Filing SIDs Before FCE Is Active
Submitting scheduled processes against an FCE number that has not yet been validated against the linked FFR causes automatic rejection in FDA Industry Systems.
No Qualified Process Authority Letter
Submissions lacking a Process Authority signature, credentials, or supporting thermal/acidification data are rejected under 21 CFR 113.83 and 114.83.
pH or Water Activity Outside Filed Range
Production batches outside the filed pH/aw window are treated as unauthorized processes — a major Warning Letter trigger and frequent recall cause.
Container or Formulation Change Without New SID
Switching can sizes, jar geometry, lid material, or recipe ratios without filing a new SID is one of the most common audit findings on inspection.
No BPCS-Certified Supervisor on Shift
21 CFR 113.10 / 114.10 require an FDA-recognized Better Process Control School-certified supervisor on every shift — missing this is an instant 483 observation.
Mismatched FFR and FCE Data
If facility name, address, owner, or operator data differs between the FFR and FCE, FDA flags the FCE as orphaned and the linked SIDs become unenforceable.
Unreported Process Deviations
Failing to document or evaluate scheduled-process deviations under 21 CFR 113.89 / 114.89 frequently escalates from a 483 observation to a full Warning Letter.
Lapsed Biennial FFR Renewal
FCE depends on an active FFR. Missing the biennial FFR renewal (October–December of even years) automatically deactivates the FCE and refuses all U.S. shipments.
Complete FDA Compliance Solutions
We offer a full range of FDA registration and compliance services to help your facility and shipments meet all U.S. regulatory requirements.
Foreign Food Facility Registration
Register your foreign food facility with the FDA — required for all facilities exporting food to the U.S.
Domestic Food Facility Registration
Register your U.S.-based food facility with the FDA under the Food Safety Modernization Act (FSMA).
U.S. Agent Services
Designate a U.S. FDA Agent for your foreign food facility — legally required for all FDA-registered food facilities.
FSVP Compliance
Ensure your U.S. importer meets FDA's Foreign Supplier Verification Program requirements.
Annual Registration Renewal
FDA food facility registrations must be renewed every two years. We handle the biennial renewal process for you.
Shipment Compliance Consulting
Expert guidance on FDA import requirements, shipment monitoring, and avoiding costly import alerts.
HACCP Plan Development
Develop and review your HACCP food safety plan to meet FDA requirements and protect your facility's compliance status.
Label & Ingredient Review
Ensure your product labels and ingredient declarations meet all FDA labeling requirements before entering the U.S. market.
Import Alert Assistance
Get expert help resolving FDA import alerts and detentions to restore your products' ability to enter the U.S.
DUNS Request Assistance
We help you obtain your DUNS number, required for FDA food facility registration and federal business activities.
FSVP for Amazon Sellers
Specialized FSVP compliance for Amazon sellers importing food products — meet FDA requirements and keep your listings active.
Food Canning Establishment (FCE-SID)
Register your acidified or thermally processed low-acid food facility with the FDA as required for canned and shelf-stable products.
Frequently Asked Questions About FCE Registration & SID Process Filing
Find answers to the most common questions about FDA Prior Notice requirements, filing deadlines, and how FDA Registration Assistance ensures your shipments comply.
What is a Food Canning Establishment (FCE) registration?
An FCE registration is an FDA requirement under 21 CFR Part 108 for facilities that manufacture, process, or pack low-acid canned foods (LACF) or acidified foods in hermetically sealed containers intended for U.S. consumption. FDA Registration Assistance handles the full FCE registration process on your behalf.
What is a low-acid canned food (LACF)?
A low-acid canned food (LACF) is any food with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, packaged in a hermetically sealed container. Tomatoes and tomato products with a pH of 4.7 or lower are excluded. Learn more about LACF compliance.
What is an acidified food (AF)?
An acidified food is a low-acid food to which acid or acid foods have been added to achieve a finished equilibrium pH of 4.6 or below, with a water activity greater than 0.85. Acidified foods packaged in hermetically sealed containers are subject to the same FCE and SID filing requirements. FDA Registration Assistance can confirm whether your product qualifies.
Is FCE registration different from FDA Food Facility Registration (FFR)?
Yes. FFR is required for all food facilities, while FCE registration is an additional requirement specifically for processors of LACF and acidified foods. The FCE registration must be linked to your existing FFR, and all data must match exactly between both records. FDA Registration Assistance ensures both registrations are properly aligned.
What is a SID number and what is a process filing?
A process filing documents how a food product is safely processed to prevent hazards such as Clostridium botulinum. Each filed process receives a unique Submission Identifier (SID) number from the FDA, which is used to track compliance. FDA Registration Assistance prepares and submits all process filings on your behalf.
Do I need a separate SID filing for each product?
Yes. Separate process filings are required for each product, each product formulation or style, each container size and type, and each processing method used. This means a single facility may require multiple SID filings. FDA Registration Assistance manages all filings for your full product range.
Who must establish the scheduled process?
A qualified Process Authority — a person with expert knowledge in thermal processing — must establish and validate the scheduled process before it is filed with the FDA. FDA Registration Assistance works with recognized Process Authorities to ensure your filings meet all regulatory requirements. Contact us to get started.
Does FCE registration apply to foreign facilities?
Yes. Both domestic and foreign establishments that manufacture or process LACF or acidified foods for sale in the United States must comply with 21 CFR Part 108, including FCE registration and SID process filings. FDA Registration Assistance serves clients in 135+ countries worldwide.
What happens if I don't register or file scheduled processes?
Failure to comply with FCE registration and SID process filing requirements may result in FDA product detention or refusal at U.S. ports of entry, Import Alert issuance (DWPE), FDA enforcement action and warning letters, and inability to sell products in the U.S. market. FDA Registration Assistance helps you avoid these costly consequences.
How long does FCE registration and SID filing take?
Processing times vary depending on FDA workload and the completeness of your submission. FDA Registration Assistance prepares complete, accurate applications to minimize delays. We provide 24–48 hour turnaround on our end to submit your documents promptly. Contact us for a timeline estimate specific to your situation.
What information is needed to complete FCE registration?
To complete FCE registration, you will need your establishment name and address, FDA Food Facility Registration (FFR) number, contact information, and details about the LACF or acidified food products you process. FDA Registration Assistance will guide you through the entire information-gathering process.
What information is required for a SID process filing?
Each SID process filing requires the product name and description, pH and water activity data, container type and size, processing method, scheduled process documentation from a qualified Process Authority, and facility details. FDA Registration Assistance handles all documentation and submission on your behalf.
Do FCE registrations need to be renewed?
FCE registrations do not expire, but must be updated whenever facility information changes, new products are added, or processing methods are modified. Each new product or process change requires an additional SID filing. FDA Registration Assistance provides ongoing support to keep your registrations current.
Can FDA Registration Assistance manage the entire FCE and SID process?
Yes. FDA Registration Assistance manages the complete FCE registration and SID process filing workflow — from initial facility review and document preparation to submission, tracking, and ongoing compliance support. We handle all FDA communication on your behalf. Contact us to get started today.
What is the fee for FCE registration and SID filing services?
Fees are based on the number of products, formulations, and container types requiring SID filings, as well as the complexity of your FCE registration. Contact FDA Registration Assistance for a custom quote tailored to your facility and product range.
What regulations govern FCE registration and SID process filings?
FCE registration and SID process filings are governed by 21 CFR Part 108 (Emergency Permit Control), 21 CFR Part 113 (Thermally Processed Low-Acid Foods), and 21 CFR Part 114 (Acidified Foods). FDA Registration Assistance ensures your submissions fully comply with all applicable regulations.
What exactly does the $1,250 FCE Registration & SID filing fee include?
The $1,250 USD annual fee includes one FCE registration (FDA Form 2541) plus one SID process filing (FDA Form 2541d, 2541e, 2541f, or 2541g, depending on product type), document review, FDA Industry Systems portal submission, confirmation tracking, and email support throughout that registration year. The FDA itself charges no government filing fee. Additional SIDs are billed per filing because each unique product, formulation, container size, and process method requires its own submission. If you also need the prerequisite FDA Food Facility Registration (FFR), we can bundle both services for a combined annual rate — contact us for the package quote.
Can a friend or unrelated party file the FCE and SID on my behalf?
No — not safely. While anyone with FDA Industry Systems credentials can technically submit the forms, the scheduled process itself must be established and signed off by a qualified Process Authority under 21 CFR 113.83 and 114.83. A friend without thermal-process expertise cannot legally validate the process, and an incorrect SID exposes you to product detention, Class I recall risk, and personal liability for the responsible individual named on the FCE. FDA expects the filer to be an authorized representative of the establishment with documented knowledge of the operation. FDA Registration Assistance files as your authorized agent with full document trail.
What happens if FDA doesn't respond to my FCE or SID filing?
FCE numbers are issued automatically upon successful electronic submission, and SID numbers are typically returned within minutes to a few business days via the FDA Industry Systems portal. If you do not receive confirmation within 10 business days, the submission likely failed validation — common causes include FFR mismatch, missing Process Authority signature, incomplete pH or water activity data, or container-code errors. FDA Registration Assistance monitors every submission, follows up directly with the FDA LACF Registration Coordinator at CFSAN, and resubmits corrections at no extra charge within your service year.
How do I change the FCE information on an existing FDA registration?
Updates are filed by logging into FDA Industry Systems, opening the existing FCE record, and submitting an amendment via FDA Form 2541. Per 21 CFR 108.25(c)(2) and 108.35(c)(2), changes to facility ownership, location, name, or commercial status must be reported within a reasonable period. Any change to a product's formulation, container, or scheduled process requires a new SID filing — you cannot simply edit an existing SID. FDA Registration Assistance handles amendments, ownership transfers, and SID re-filings as part of ongoing client support.
Does my fermented hot sauce need an FCE registration and SID filing?
Usually yes. If your fermented hot sauce is shelf-stable in a hermetically sealed bottle and the finished equilibrium pH is at or below 4.6 with water activity above 0.85, FDA classifies it as an acidified food under 21 CFR Part 114 — and FCE registration plus a SID filing are required before you can sell it commercially or ship into U.S. commerce. Naturally fermented sauces that achieve pH ≤ 4.6 purely through fermentation (no acid added) may instead fall under acid-food rules, but FDA enforcement guidance still recommends a Process Authority letter confirming classification. Contact us to confirm your product category.
Do I need FCE registration if I only sell my canned products on Amazon or Shopify?
Yes. The sales channel does not change the regulation — FCE and SID filings are required for any commercial LACF or acidified food in hermetically sealed containers entering U.S. commerce, including direct-to-consumer e-commerce. Amazon's FSVP and food-category compliance reviews increasingly request the FCE number and SID for canned, jarred, and pouched food listings, and missing documentation has triggered listing suspensions and ASIN removals. Shopify itself does not enforce FDA rules, but FDA can still issue a Warning Letter or seize product. See our Amazon seller compliance service.
Are pickled vegetables considered acidified foods under FDA rules?
Yes, in most cases. Pickled cucumbers, peppers, beets, carrots, and similar vegetables packed in vinegar brine and sold shelf-stable in sealed jars are acidified foods under 21 CFR 114.3(b) when the finished pH is at or below 4.6 and water activity is above 0.85. They require FCE registration and a SID filing. Refrigerated pickles labeled "Keep Refrigerated" with a controlled cold chain may be exempt, but the burden of proof is on the manufacturer. FDA Registration Assistance can confirm classification with a Process Authority review.
Do kombucha producers need to file an FCE and SID with the FDA?
It depends on packaging and alcohol content. Shelf-stable, hermetically sealed kombucha with pH at or below 4.6 generally falls under acidified food regulations and requires FCE and SID filings. Kombucha exceeding 0.5% alcohol by volume is regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), not FDA, and is outside the FCE program. Refrigerated kombucha distributed under continuous cold chain may avoid FCE/SID requirements but still needs FDA Food Facility Registration. Contact us for product-specific guidance.
How can I verify that my FCE registration is currently active with FDA?
Log into the FDA Industry Systems portal (access.fda.gov) using the account associated with your FCE, open the "LACF Registration" module, and confirm the FCE number, establishment address, and product list. FDA does not publish FCE numbers in a public lookup tool, so internal portal access is the only authoritative verification method. If you cannot access the account, FDA Registration Assistance can recover the registration on your behalf with proper authorization documentation.
Does one FCE registration cover multiple facility addresses?
No. Per 21 CFR 108.25(c)(1) and 108.35(c)(1), each physical establishment that manufactures, processes, or packs LACF or acidified foods must have its own FCE number tied to its unique address. A company operating two production facilities needs two separate FCE registrations and a complete set of SID filings for the products processed at each location, even if the products are identical. FDA Registration Assistance can manage multi-site FCE portfolios under a single account.
Are honey, jam, and jelly subject to FCE and SID filing requirements?
Generally no. Honey, jams, jellies, and preserves with high sugar content typically have a water activity below 0.85, which removes them from the LACF and acidified food definitions in 21 CFR 113.3 and 114.3. These products still require FDA Food Facility Registration but not FCE or SID filings. However, low-sugar or "reduced sugar" fruit spreads can exceed the water-activity threshold and may need FCE/SID — a Process Authority review is recommended before assuming exemption.
Can I use my co-packer's FCE number instead of registering my own?
Yes, if the co-packer actually produces the product. The FCE belongs to the establishment that performs the thermal processing or acidification — not the brand owner. If your co-packer handles the canning at their facility, their FCE and their SID filings cover that production. You as the brand owner only need your own FCE if you operate a separate production location. Confirm the co-packer's FCE and SID numbers in writing before launch and keep a copy on file for FDA inspections. FDA Registration Assistance can audit co-packer documentation as part of due diligence.
Does FCE registration apply to refrigerated acidified or LACF-style products?
Not usually. The 21 CFR Part 108 program applies specifically to shelf-stable products in hermetically sealed containers. Products that require continuous refrigeration to remain safe — and are clearly labeled "Keep Refrigerated" with a controlled cold-chain distribution — are generally outside FCE and SID requirements but fall under FSMA Preventive Controls (21 CFR Part 117) instead. Misclassifying a shelf-stable product as refrigerated to avoid FCE filing is a frequent cause of FDA Warning Letters. Contact us if you're unsure how to classify your product.
What is the difference between an FCE number and a SID number?
The FCE (Food Canning Establishment) number identifies the physical facility — one number per address. The SID (Submission Identifier) number identifies one specific scheduled process for one product, one formulation, one container, and one processing method. A single FCE-registered facility producing five products in two container sizes will hold one FCE number but typically ten or more SID numbers. Both must be active and linked for the products to be legal in U.S. commerce. FDA Registration Assistance tracks every FCE and SID under your account.
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