Food Canning Establishment Registration (FCE) & Submission Identifier SID
Who Must Comply with FCE & SID Requirements?
In addition to FDA Food Facility Registration, most companies that manufacture shelf-stable foods—such as canned, bottled, jarred, or vacuum-packed products—are required by the U.S. FDA regulations to obtain a Food Canning Establishment (FCE) registration number and file Submission Identifiers (SID) before importing or distributing these products in the U.S. market. This rule applies to both Low-Acid Canned Foods (LACF, with a pH above 4.6) and Acidified Foods (AF, with a pH below 4.6). Upon successful registration, the FDA assigns a unique 5-digit FCE number to identify each processing facility.
Furthermore, the FDA requires manufacturers of LACF and AF items to submit scheduled process filings for each product, including every variation in style, container size, packaging type, and processing method. Consequently, each process filing is assigned a unique 11-digit Submission Identifier (SID) by the FDA, tied to the specific product and packaging. The SID is not the same as the FDA Food Facility Registration number, though both are 11 digits. To legally import LACF or AF food items into the U.S., manufacturers must have both a FCE number and a valid SID for each product.
Furthermore, the FDA requires manufacturers of LACF and AF items to submit scheduled process filings for each product, including every variation in style, container size, packaging type, and processing method. Consequently, each process filing is assigned a unique 11-digit Submission Identifier (SID) by the FDA, tied to the specific product and packaging. The SID is not the same as the FDA Food Facility Registration number, though both are 11 digits. To legally import LACF or AF food items into the U.S., manufacturers must have both a FCE number and a valid SID for each product.
Key Considerations for FCE & SID Registration
The FDA only allows the AF, LACF manufacturer, or their official FDA agent to create an FCE account and submit SIDs. Remember, wholesalers, US distributors or other players are not allowed to create an FCE account or apply for one on behalf of the manufacturer.
Before initiating the SID submission process, companies must ensure they can generate the required food safety and process filing documentation. These documents shall be prepared by a Process Authority either in-house or through a qualified third-party laboratory. A Process Authority is a qualified expert responsible for evaluating and approving the safety of processing methods for certain food products, particularly acidified and low-acid canned foods.
Through the creation of a key document known as the Process Source, the Process Authority must demonstrate that all critical factors have been adequately evaluated, that the food safety of the product is scientifically supported, and that the findings are documented in a process summary for acidified and low-acid foods.
Furthermore, Heat Penetration (HP) and Temperature Distribution (TD) studies, which are specific to sterilizer systems (retorts), are examples of documents often required during SID submission for mainly low-acid foods. By ensuring these steps are completed ahead of time, companies can facilitate a smoother submission process for SID and FDA review, thereby minimizing the risk of delays or interruptions.
Unless exempt, foods that fall under Food Canning Establishment requirements must also comply with the FDA Preventive Controls Rule, necessitating the designation of a Preventive Controls Qualified Individual (PCQI) for Food Safety plan development.
Creating FCE and submitting the SID fillings usually takes 10-15 days. Generally, within 3-5 days after the fillings are completed, the FDA will review the SIDs and either approve them or provide comments and request additional product information. Registration of acidified food AF typically takes a shorter time. Low-acid canned food LACF SID usually takes longer to submit and get approved.
Before initiating the SID submission process, companies must ensure they can generate the required food safety and process filing documentation. These documents shall be prepared by a Process Authority either in-house or through a qualified third-party laboratory. A Process Authority is a qualified expert responsible for evaluating and approving the safety of processing methods for certain food products, particularly acidified and low-acid canned foods.
Through the creation of a key document known as the Process Source, the Process Authority must demonstrate that all critical factors have been adequately evaluated, that the food safety of the product is scientifically supported, and that the findings are documented in a process summary for acidified and low-acid foods.
Furthermore, Heat Penetration (HP) and Temperature Distribution (TD) studies, which are specific to sterilizer systems (retorts), are examples of documents often required during SID submission for mainly low-acid foods. By ensuring these steps are completed ahead of time, companies can facilitate a smoother submission process for SID and FDA review, thereby minimizing the risk of delays or interruptions.
Unless exempt, foods that fall under Food Canning Establishment requirements must also comply with the FDA Preventive Controls Rule, necessitating the designation of a Preventive Controls Qualified Individual (PCQI) for Food Safety plan development.
Creating FCE and submitting the SID fillings usually takes 10-15 days. Generally, within 3-5 days after the fillings are completed, the FDA will review the SIDs and either approve them or provide comments and request additional product information. Registration of acidified food AF typically takes a shorter time. Low-acid canned food LACF SID usually takes longer to submit and get approved.
FCE Registration & First SID Submission Process
Cost: $849 (Each Additional SID $195)
Step 1
Complete the initial form below, and tell us about your company
Step 2
We will issue you a short and simple questionnaire to assess if SID is required and verify production data
Step 3
We prepare a draft for your review, and after receiving your approval, FCE account creation and SID Submission
Step 4
Review of the filed SID by FDA (2-4 days)
Step 5
FDA approval of SID filings, and we issue your confirmation
A Few Important Things To Note:- Our fee includes U.S. Agent services for foreign companies. We provide professional U.S. Agent representation to facilitate compliance and communication with the U.S. FDA. No additional fees required for U.S. Agent services.- Food facilities must renew their registrations every even-numbered year between October 1 and December 31. We work with you to manage this process to ensure your registration remains active and maintained, preventing issues at the border.- The FDA requires foreign facilities to provide a D-U-N-S Number for registration. If you don’t have one, we can assist in obtaining it for an additional fee.