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The routes

Refrigerated or frozen

Updated

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The simplest route out: do not make it shelf stable.

Why it works

Part 113 and 108.35 are about thermally processed low-acid foods in hermetically sealed containers, aimed at products held under normal nonrefrigerated conditions of storage and distribution. A refrigerated or frozen product is not that.

What you take on instead

A cold chain. Temperature control from your kitchen to the customer, which is an operational and logistical problem rather than a regulatory approval. For a local or farmers market business that is often entirely manageable.

Frozen is the easier of the two

A longer safety margin, far more forgiving of a delay, and it ships with insulation and coolant rather than requiring continuous refrigeration. Most small soup and broth businesses that work are frozen.

The container question changes too

A frozen product needs headspace for expansion and a container that tolerates freezing without cracking. Glass can be used with care and adequate headspace, and this is where asking about freeze tolerance specifically matters.

And labeling has to say so clearly

Keep refrigerated or keep frozen, prominently, because a customer who treats a refrigerated product as shelf stable has defeated the entire basis of the approach. That instruction is a safety control.

Preventive controls still apply

The current good manufacturing practice and risk-based preventive controls rules for human food do not go away. Avoiding part 113 is not avoiding food safety regulation; it is choosing a different and more proportionate part of it.

It is the answer we would give most people

Frozen broth in a glass jar with proper headspace, sold locally or shipped cold, with a clear keep-frozen instruction. That is a real business and it does not need a retort.

It is not a lesser answer

Frozen broth is a real product with a real market, and treating shelf stability as the goal rather than one option is what pushes people toward a regime they cannot operate. Most of the good small producers in this category are frozen.

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 part 117, the current good manufacturing practice, hazard analysis and risk-based preventive controls regulations for human food, which apply alongside the thermal processing rules. 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.