Tools and directories

The check, before anything is filled

Updated October 2026

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One: what is the finished equilibrium pH, and the water activity?Two: does it have to be shelf stable?Three: if shelf stable, who establishes the process?Four: does the container match the filed process?And if you acidify instead Keep the pH and temperature records per batch The jar is the last decision and the easiest Two of the four can end the exercise, and that is the point References

Four questions. If it is shelf stable and above 4.6, stop and call a process authority.

One: what is the finished equilibrium pH, and the water activity?

Measured, on the settled finished product, with a calibrated meter and a water activity instrument. Above 4.6 and above 0.85 on both means the food is low-acid within the definition.

Two: does it have to be shelf stable?

If no, go refrigerated or frozen and part 113 does not apply. If yes, and the food is low-acid, you are in the thermally processed low-acid canned food regime and the next call is a competent processing authority.

Three: if shelf stable, who establishes the process?

A competent processing authority, for your product in your container at your fill. Then register on Form FDA 2541 within ten days of first engaging, and file the process. A co-packer who already has all of that is the realistic route.

Four: does the container match the filed process?

Because the process belongs to the product in the container. Jar size, shape, headspace and fill weight are all in it, so the filed process chooses the jar rather than the other way round.

And if you acidify instead

Finished equilibrium pH at or below 4.6, measured after the solids and liquid have equilibrated, under the acidified foods regime. The written site on Pickles is the detailed treatment of that route.

Keep the pH and temperature records per batch

Ingredient acidity varies by season and supplier, so the measurement is per batch rather than per recipe. The records are the evidence, and without them the measurement might as well not have happened.

The jar is the last decision and the easiest

18 glass containers from 266 to 946 mL, all rated to 300 F, with 11 lug closures and 11 pasteurization liners. Ask about those eleven, and ask the process authority first.

Two of the four can end the exercise, and that is the point

Most checks in this library add work to a project. These two can tell you the project is not what you thought, and finding that out before a case of jars arrives is the entire value of the page.

References

21 CFR 113.3, the definitions for thermally processed low-acid foods packaged in hermetically sealed containers. Paragraph (j) defines a hermetically sealed container as one designed and intended to be secure against the entry of microorganisms so as to maintain commercial sterility; (n) defines low-acid foods as those with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products below pH 4.7; (r) requires a scheduled process at least equivalent to one established by a competent processing authority. law.cornell.edu

21 CFR 108.35, Thermal processing of low-acid foods packaged in hermetically sealed containers. Paragraph (a) records that the harmful nature of such foods cannot be adequately determined after they have entered interstate commerce; (c)(1) requires a commercial processor to register with FDA on Form FDA 2541 not later than 10 days after first engaging in such processing, giving the establishment locations, the processing method in terms of equipment employed, and a list of the low-acid foods processed. law.cornell.edu

21 CFR part 114, Acidified foods, the regime for foods to which acid or acid foods are added to produce a finished equilibrium pH of 4.6 or below, which is the alternative route for a product that would otherwise be low-acid. law.cornell.edu

21 CFR part 113 generally, which sets the equipment and procedural requirements for thermal processing systems, including instrumentation, venting, temperature and pressure records and operator supervision for each type of retort. law.cornell.edu

Written from federal regulation, not from a production kitchen. Nothing here is a scheduled process, and nothing here is a substitute for a competent processing authority. If you are considering a shelf-stable low-acid product, the first call is to a process authority rather than to a packaging supplier.