Food Canning Establishment Registration FCE & Submission Identifier SID

Q: What is the deadline to file FCE and SID with the FDA?

Facilities must complete FCE registration within 10 days of starting commercial production, and SID process filings must be submitted within 60 days of FCE registration (and prior to shipping).

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Who Must Comply with FCE & SID Requirements?

In addition to FDA Food Facility Registration, companies producing shelf-stable foods—such as canned, bottled, jarred, or vacuum-packed products—must obtain a Food Canning Establishment (FCE) registration number and file Submission Identifiers (SID) before importing or distributing these products in the U.S. This FDA requirement applies to Low-Acid Canned Foods (LACF, with a pH above 4.6) and Acidified Foods (AF, with a pH below 4.6). Upon registration, the FDA assigns a unique 5-digit FCE number to each processing facility.

Furthermore, manufacturers of LACF and AF products must submit scheduled process filings for each product variation, including style, container size, packaging type, and processing method. Each filing receives a unique 11-digit SID linked to the specific product and packaging. The SID is different from the FDA Food Facility Registration number. Therefore, manufacturers must have both an FCE number and a valid SID for each product to legally import LACF or AF foods into the U.S.

FCE Registration & SID Filling Steps

1- Creation of an FCE account for the manufacturer

2- Obtaining the low-acid/ acidified food process information

3- Submission of low-acid/ acidified product data by FDA Agent

4- Review of the SID submissions and approval notice by the FDA

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.

How do FCE-SID Exceptions Work?

It’s not always easy to determine whether your food and beverage products require an FCE-SID submission or if the FDA excludes them through an exemption. However, to avoid costly FDA import detentions, it is essential to consult with FDA consultants who are experts in this area. To determine whether your product is LACF, AF, or excluded from SID submission, you can request our free initial assessment expert service.

Sharing your food product’s pH and water activity levels, as well as its acidifying contents, will help us make a more accurate assessment of whether FCE-SID is required. Alternatively, manufacturers can directly contact the FDA’s LACF department at LACFtechnical@fda.hhs.gov to verify whether an SID submission is necessary for a specific product.

How Can We Assist?

If you manufacture Acidified or Low-Acid Canned Foods, FDA Listing Inc. can help ensure your Food Canning Establishment is correctly registered with the FDA and that each product’s scheduled process is accurately filed. Our FCE & SID service includes one year of complimentary expert consultation for your new products. If you need assistance, contact us by email or phone anytime.

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