Acidified Foods: Scheduled Processes and Acidification Controls

The definition concerns low-acid food to which acid or acid food is added, with specified equilibrium pH and water activity. Several product categories are excluded under the definition. Product name, sour taste or an acidic ingredient alone does not determine classification. The formula, finished equilibrium pH, processing and storage conditions establish the appropriate regulatory question. Part 114 definitions.

The scheduled process is established by a qualified person with expert knowledge of acidification and processing. It addresses the factors necessary to produce a safe food under the specified formulation and container conditions. Production must follow that process, including the controls needed to reach and maintain the required equilibrium pH. A kitchen recipe is not equivalent process evidence. Processing requirements.

pH measurement and relevant critical-factor controls require suitable methods and instruments. Operations are supervised by personnel who satisfy the applicable training provisions. Measurements must relate to the finished product and the point in the process specified by the scheduled process. Records should make the connection between a reading, the batch, the instrument and any adjustment or deviation. Part 114.

A commercial acidified-food processor has registration and scheduled-process filing duties under section 108.25. FDA’s electronic-submission explanation identifies Form FDA 2541e for acidified-food process information. The filed information is product and container specific. Establishment registration and filing do not replace implementation of the scheduled process, and should not be described as general FDA certification of the food. FDA filing explanation.

A departure from the scheduled process requires the evaluation and disposition prescribed by the regulation. Production, pH and other critical-factor records support identification of affected product. Container coding and distribution information help connect a processing issue to the food released. Commercial sterility controls for low-acid canned foods belong to the separate Part 113 framework. Records and deviations.

Establish the product’s composition, water activity, equilibrium pH, container and storage model. Determine whether the acidified-food definition applies before selecting a process-filing form. Compare the scheduled process with the production instructions and records used on the line. Reassess changes to formula, container or process with the responsible qualified expertise. Part 108 · FDA filing resources.