Food Canning Establishment Registration FCE & Submission Identifier SID

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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.

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 either in-house or through a qualified third-party laboratory. By ensuring this step is completed ahead of time, companies can facilitate a smoother submission process for SID and FDA review, thereby minimizing the risk of delays or interruptions.

Heat Penetration (HP) and Temperature Distribution (TD) studies, specific to sterilizer systems (retort), are examples of documents often required during SID submission for low-acid foods. Furthermore, the Process Authority must demonstrate that critical factors are satisfactorily examined, that food safety is scientifically substantiated, and that the study results are reported in process summary documentation for acidified and low-acid foods.

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.

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.

Service Details & Fees

795 USD

195 USD

2-3 Days

_______ Related Services _______

Frequently Asked Questions (FAQ)

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

U.S. FDA requires ﬁlling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After ﬁlling the Prior Notice, you will be assigned with a conﬁrmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be ﬁled by your own compnay or international transit ﬁrms as well as shipment companies (DHL, FedEx, TNT, etc).

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

Frequently Asked Questions (FAQ)

Service Details & Fees

First SID Submission

795 USD

Each Additional SID

195 USD

Time Required (Filing)

2-3 Days

FCE Registration

30-Min Expert Consultation

FDA Communications