FCE & SID Registration: What Canned Food Exporters Must Know

What Are FCE and SID Registrations?

Beyond standard food facility registration, manufacturers of thermally processed low-acid foods packaged in hermetically sealed containers (commonly called LACF — Low-Acid Canned Foods) must obtain two additional FDA registrations:

• FCE (Food Canning Establishment) registration under 21 CFR Part 108 and 113
• SID (Scheduled Process Identifier) registration for each specific product and process combination

These requirements exist because improperly processed low-acid canned foods can harbor Clostridium botulinum, the bacterium that produces the deadly botulinum toxin. The FDA takes these regulations extremely seriously.

What Products Require FCE/SID?

FCE and SID registration is required for products that meet all three criteria:

1. The food has a finished equilibrium pH greater than 4.6 (low-acid)
2. The food has a water activity (aw) greater than 0.85
3. The food is packaged in a hermetically sealed container (cans, retort pouches, jars with vacuum seals)

Common products that require FCE/SID registration include canned vegetables, canned meats and seafood, canned soups and stews, retort pouch meals, canned sauces, and canned coconut milk.

The FCE Registration Process

1. 1
   Establish your thermal process You must have a scientifically established thermal process (the specific time and temperature treatment) validated by a recognized Process Authority — typically an accredited food science laboratory or consultant.
2. 2
   Register as a Food Canning Establishment Submit your FCE registration to the FDA's LACF Registration System. This registers your facility specifically for LACF production, separate from your general food facility registration.
3. 3
   File your Scheduled Process (SID) For each unique product and container/closure/process combination, you must file a Scheduled Process. This details your validated thermal process parameters.
4. 4
   Receive your FCE and SID numbers The FDA assigns an FCE number to your establishment and a SID number to each filed process. These must appear on your product labels and import documentation.

What Happens If You Don't Register?

The consequences of shipping LACF products without valid FCE and SID registrations are severe:

• Automatic detention of your shipment at the U.S. port of entry
• Possible refusal of admission and mandatory re-export or destruction at your cost
• Placement on an FDA Import Alert list, which can affect all future shipments
• Civil and criminal penalties under the FD&C Act

Label Requirements for LACF Products

In addition to standard FDA food label requirements, LACF products exported to the U.S. must display your FCE registration number and your SID number on the label or affixed documentation. This allows FDA inspectors to immediately verify compliance at the border.

How Regovant Can Help

Regovant works with experienced Process Authorities and can guide you through the entire FCE/SID registration process. We ensure your thermal process documentation is complete and that your registrations are filed correctly before your first shipment leaves your facility.