Exporting Canned Food to the United States: FCE, SID, and Thermal Process Filing Requirements

Canned food is one of the most heavily regulated food categories entering the United States. Any foreign manufacturer that produces thermally processed low-acid canned foods (LACF) or acidified foods in hermetically sealed containers must complete a set of FDA filings that go far beyond standard food facility registration. These filings — Food Canning Establishment (FCE) registration and Scheduled Process Identifier (SID) submissions — are mandatory under 21 CFR Parts 108, 113, and 114, and no thermally processed canned product may be distributed in the US without them. The consequences of non-compliance are immediate: shipments will be detained at the port, and the facility may be placed on an import alert that blocks all future exports to the United States.

FCE registration under 21 CFR 108.25

Every commercial processor of thermally processed low-acid canned foods or acidified foods must register with the FDA as a Food Canning Establishment. FCE registration is separate from — and in addition to — the standard FDA food facility registration required under the Bioterrorism Act. The FCE registration assigns a unique FCE number to the establishment, which is used to track all scheduled process filings associated with that facility. The registration is submitted through FDA's LACF online system and must include the facility name, address, type of products processed, and the methods of thermal processing used. The FCE registration must be updated whenever there are changes to the facility's processing operations, equipment, or product lines.

Scheduled Process filings under 21 CFR 108.35

For each product processed at the facility, the manufacturer must file a Scheduled Process with the FDA. The Scheduled Process is the specific thermal treatment — time, temperature, and other critical factors — that the product receives to achieve commercial sterility (for LACF) or adequate acidification (for acidified foods). Each Scheduled Process filing receives a unique Submission Identifier (SID). A separate SID is required for each combination of product formulation, container size, container type, and processing method. This means a facility that cans the same tomato sauce in three different can sizes must file three separate SIDs.

The Scheduled Process must be established by a competent processing authority — a person or organization with expert knowledge of thermal processing, acidification, and container closure technology. The processing authority evaluates the product's characteristics (pH, water activity, consistency, fill weight, headspace) and determines the minimum thermal process required to achieve commercial sterility. For LACF, this typically means a thermal process sufficient to destroy Clostridium botulinum spores — the most heat-resistant pathogen of concern. For acidified foods, the process must achieve and maintain an equilibrium pH of 4.6 or below to prevent C. botulinum growth.

Low-acid canned foods under 21 CFR Part 113

A low-acid canned food is defined as any food (other than alcoholic beverages) with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, packaged in a hermetically sealed container and subjected to a thermal process either before or after hermetic sealing. This includes canned vegetables, soups, stews, meats, poultry, seafood, sauces, gravies, and many prepared meals. 21 CFR Part 113 requires LACF processors to maintain detailed records of every processing batch, including retort temperature and time, initial temperature, container closure inspections, and any deviations from the scheduled process. Equipment must be calibrated and maintained, and operators must be trained — typically through a Better Process Control School (BPCS) course recognized by the FDA.

Acidified foods under 21 CFR Part 114

Acidified foods are low-acid foods to which acid or acid foods are added to achieve a finished equilibrium pH of 4.6 or below. Common examples include pickled vegetables, salsas, hot sauces, relishes, and certain condiments. 21 CFR Part 114 requires the same FCE registration and SID filing as LACF products, plus specific pH monitoring requirements. The critical control point for acidified foods is the achievement and maintenance of the target pH — if the pH rises above 4.6, the product is potentially hazardous and must be treated as a low-acid food with a full thermal process. Acidified food processors must measure and record the pH of each batch, and the equilibrium pH must be achieved within the time specified in the scheduled process.

Container integrity and closure requirements

Both LACF and acidified food regulations require rigorous container closure evaluations. For metal cans, this means performing double-seam teardown examinations at regular intervals during production to verify that the seam dimensions (overlap, body hook, cover hook, tightness, and countersink depth) meet specifications. For glass containers, closure torque and vacuum measurements must be recorded. For flexible and semi-rigid containers (pouches, trays), seal integrity testing — such as burst testing, dye penetration testing, or visual inspection — must be performed and documented. A defective seal renders the hermetic seal ineffective and creates a risk of post-process contamination, which can lead to botulism or other serious foodborne illness.

How FDABridge handles canned food compliance

FDABridge manages FDA food facility registration and FCE/SID filings for foreign canned food manufacturers. Our team can coordinate with your processing authority to ensure all scheduled process data is properly formatted and submitted to the FDA's LACF system, and we handle the full registration sequence — DUNS number, food facility registration, FCE registration, and SID submissions — as a single integrated process. Visit fdabridge.com/food to see our food registration services or fdabridge.com/contact to discuss your canned food compliance needs.