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FDA – Food and Dietary Supplements

FCE Registration

Fee: $399

Establishments that manufacture low-acid canned food (LACF) or acidified food register with FDA as a food canning establishment (FCE), separately from the general facility registration. The registration is made within 10 days after this production begins; for acidified food, foreign establishments must register before the product is presented to customs for import into the United States.

Who Is Obligated?

Domestic and foreign establishments that ship low-acid canned food or acidified food to the United States.

What We Do

  • We assess whether your product falls into the low-acid or acidified food category.
  • We file the FCE registration on your behalf.
  • We update changes in the registration details.

What You Receive

  • FCE number
  • Summary of the information used in the registration
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FDA Food Canning Establishment (FCE) Registration Application

Facility, product list, and contact person details for the FCE registration of your facility producing low-acid canned or acidified foods on Form FDA 2541.

  1. 1 Preliminary Information
  2. 2 Facility
  3. 3 Products
  4. 4 Contact Person and Billing
  5. 5 Submit
1. Preliminary Information
Requested action *
Does the facility have an FDA facility registration number (food facility registration)? *

Electronic FCE registration is available to facilities flagged as low-acid / acidified food processors in their food facility registration. If you have no registration, also complete the food facility registration form.

Your details are used only to prepare your application. An unfinished application is kept in this tab.

Frequently Asked Questions

Does FCE registration replace the general facility registration?
No. FCE is a separate registration from the general FDA facility registration and is required only for establishments that manufacture low-acid canned or acidified food.
How do I know whether my product is covered?
We assess whether the product falls into the low-acid or acidified food category based on your product and process information.
Is there another step after FCE registration?
Yes, the scheduled process for each product is filed separately and receives a SID number. We handle this with our SID Process Filing service.

Sources: 21 CFR 108.25; 21 CFR 108.35.