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 with the FDA. Processing plants must also submit process filing forms containing scheduled process information for each acidified and low-acid canned food produced, and must meet all other requirements of the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Importers, wholesalers, distributors, brokers, etc. are excluded from the requirement to register.
Acidified foodAn 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.
Low-acid canned food
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.
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