Process registration is mandatory for ingestible products that are liquids, gels or semisolids and that are not sold frozen or refrigerated. FDA refers to products that have undergone aseptic processing as low acid and acidified ‘canned’ foods.
All commercial acidified and low-acid canned food processors located in the United States, as well as processors in other countries that export to the United States must register. The purpose of this registration is to ensure that food, beverage and dietary supplement products offered for sale in the U.S. have been treated to ensure that they will be free of microbial contamination and safe for ingestion.
If your product meets the criteria below, the manufacturing process must be registered with FDA.
FDA definition of Acidified foods:
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 nonrefrigerated conditions.
FDA definition of Low Acid foods:
A low-acid canned food has the following characteristics:
1. Equilibrium pH value greater than 4.6 and water activity greater than 0.85.
2. Sealed in a hermetic (air-tight) container (i.e., secure against the entry of microorganisms).
3. Receives a heat treatment for the purpose of achieving commercial sterility.
4. Normally stored and distributed under non-refrigerated conditions.