Food Canning Establishment Registration
All manufacturers of low acid canned food (“LACF”) and acidified canned food must submit a Food Canning Establishment (“FCE”) registration with FDA. A food product is consider a LACF if the finished equilibrium pH is greater than 4.6 and a water activity greater than 0.85 (excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7). An acidified food is a low-acid food to which acids or acid foods are added and which has a finished equilibrium pH of 4.6 or below and a water activity greater than 0.85.
Food offered for import that is manufactured in a facility without an FCE registration number will be refused admission into the United States. While only manufacturers of LACF or acidified foods are required to register, importers, wholesalers, distributors and brokers should verify with their suppliers that their FCE registration is current and accurately reflected in the customs paperwork filings. Failure to accurately report the FCE registration number will result in detention or refusal of admission of the food product.
Scheduled Process Identification
Any manufacturer that is required to register as an FCE must also submit its scheduled process for all of its LACF and acidified foods to FDA to obtain a scheduled process identification (“SID”) number for each acidified food and LACF in each container size. The manufacturer’s scheduled process must be reviewed and approved by FDA before any canned food is permitted to enter the United States. If a manufacturer modifies the manufacturing process. the type of container, acidulators or aseptic processing equipment then the manufacturer is required to submit updated SID filing. FDA reviews a manufacturer’s scheduled processes in order to reduce the risk of botulism poisoning in the food product.
Food offered for import that is manufactured in a facility with an active FCE registration number, but does not have an SID number for the imported product will be refused admission into the United States. It is important that the SID number is accurately reflected in the customs paperwork filings. Failure to accurately report the SID number associated with the food product will result in detention or refusal of admission.
Morsel Law can assist your business by preparing, evaluating and submitting your FCE and SID scheduled process applications for your canned foods and beverages. Contact us here to begin you application.