May. 23, 2024

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The FDA has set up guidelines for acidified & low acid canned foods. The name of the act is a little misleading as it refers to canned foods but please note that all aseptically packed foods irrespective of whether it is acidified or low acid fall under this act. It is a misconception that availability in the USA implies that the product was produced in compliance with FDA. There are only a small percentage of goods verified by the FDA and the responsibility of compliance remains with the importer and customers.

FDA guidelines for Acidified and low acid aseptically packed foods

Low acid canned foods are those that have a pH greater than 4.6 and a water activity greater than 0.85. They are packaged in hermetically sealed containers and receive heat treatment for the purpose of achieving commercial sterility. They are normally stored and distributed under non-refrigerated conditions. An acidified food is a low-acid food to which acid(s) or acid food(s) are added for the purpose of reducing the pH to a finished equilibrium pH of 4.6 or below. It has a water activity greater than 0.85 and is stored and distributed under non-refrigerated conditions.

All commercial acidified and low-acid canned food processors located in the United States and all processors in other countries who process acidified or low-acid canned food products for export to the United States must register. Other countries need to register and file processes only for those foods that are to be imported into the United States. A processing plant registering for the first time completes a Food Canning Establishment Registration form (FDA 2541). Separate Food Canning Establishment Registration form (FDA 2541) must be submitted for each processing plant location and a separate Food Canning Establishment (FCE) number will be assigned to each.

Firms in other countries must register before offering any acidified or low-acid canned food products for import into the United States. Otherwise, the products will be held (detained) at the port of entry until the firm meets the registration and process filing requirements. In addition, the firm must comply with all applicable mandatory provisions of 21 CFR 108, 113 and 114.

To learn in detail please refer to the FDA website:

iTi makes sure that we adhere to all regulation and we ensure that our processing plants have the proper registration before importing any of these items. Examples of products which require this registration are aseptic banana puree, aseptic coconut water and aseptic goji. When registered the FDA issues an SID # and a FCE#, which can be used by a customer to verify proper registration.


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