FCE (Food Canning Establishment) registration and SID (Submission Identifier) process filings are required for commercial processors of low-acid canned foods (LACF) and acidified foods (AF) in hermetically sealed containers (e.g., cans, jars, pouches).
FCE & SID requirement applies to both US and foreign facilities that manufacture, process, or pack such products for distribution in the U.S. market. Importers, wholesalers, distributors, brokers, or repackagers cannot file FCE or SID.
LACF are thermally processed products with a finished equilibrium pH > 4.6 and water activity > 0.85, packaged in hermetically sealed containers for shelf‑stable, non‑refrigerated storage.
Examples – canned vegetables (e.g., green beans, corn, mushrooms, potatoes, peas, spinach, carrots), canned meats (e.g., tuna, chicken, spam), seafood (e.g., sardines, clams), soups with meat/veggies. gravies, pasta in sauce, fruits in heavy syrup.
AF are low-acid foods (original pH >4.6, water activity >0.85) to which acids or acid foods are added, achieving a final equilibrium pH ≤4.6 while remaining shelf-stable in hermetically sealed containers.
Examples – pickled vegetables (e.g., beans, cucumbers, cabbage, peppers, artichokes, cauliflower), salsas, barbecue/hot sauces, pickled eggs, tropical fruit mixes, fish, and puddings acidified with vinegar, lemon juice, or citric acid.
Step by Step Process:
- Obtain Food Facility Registration
- Obtain a scheduled process from a qualified Process Authority, detailing pH, thermal processing, container specs, and safety validation
- File FCE for the plant location via FDA Form 2541
- File separate SID for each product variant, container size and type via FDA Forms 2541d/e/f/g
Liberty Management Group Ltd can help file Food Facility Registration, FCE and SID for your low acid canned and acidified food products and also help with label compliance.
Namrata
Regulatory Consultant
support@libertymanagement.us