Does my sauce or salsa need a scheduled process?

An acidified food is a low-acid food that has had acid or acid foods added to it, ending at a finished equilibrium pH of 4.6 or below and a water activity greater than 0.85. All three parts matter.

Equilibrium pH is the pH after everything has settled and mixed, not the reading you take a minute after stirring in the vinegar. Water activity above 0.85 is what separates a salsa from something shelf-stable by dryness, like a spice blend.

Salsas, pickled vegetables, many hot sauces, marinated products and dressings routinely land inside this definition. A naturally acidic product that was always below 4.6 on its own is a different category, and so is anything genuinely low-moisture.

Three things, and they are separate from ordinary facility registration:

• Register the establishment as an acidified foods processor, which gives you an FCE number
• Have a scheduled process established by a qualified person with training and experience in acidified foods — the process authority
• File that scheduled process with the FDA for each food and each container size, which returns a submission identifier

This is the part that surprises people, and it is worth being blunt about. Commercial processors of acidified foods are subject to these requirements regardless of size. A two-person operation making salsa in a rented kitchen is in the same regulatory category as a national brand.

The scale of the obligation differs — your scheduled process is simpler and your paperwork is thinner — but the obligation itself does not go away because the business is small.

A process authority is a qualified person, usually at a university food science extension or a private lab, who reviews your formulation and process and establishes the parameters that make it safe: the acid level, the timing, the fill temperature, the critical factors you then have to hold every batch.

Practically, you send them your formulation and process, they come back with a letter, and that letter is what you file and what an inspector asks to see. Budget weeks rather than days, and expect to be asked for pH readings on a real batch made the way you actually make it.

The scheduled process is tied to the formulation it was written for. Materially change the acid level, the ratio, the container or the process and the scheduled process may no longer cover you, which means going back to the process authority.

This is the practical argument for locking your formula before you scale, not after. It is cheaper to settle the recipe and then get it validated once.

This is general information for U.S. food businesses, not legal advice, and rules change. Check it against the sources below and against your own state's rules before you rely on it.

• 21 CFR Part 114 — Acidified Foods
• 21 CFR 108.25 — Acidified foods (registration and process filing)
• FDA — Establishment registration and process filing for acidified and low-acid canned foods