An acid food has a natural pH of 4.6 or below: most fruit, vinegar, a raspberry shrub. An acidified food is a low-acid food, peppers, cucumbers, beans, with acid or an acid food added, ending at a pH of 4.6 or below with a water activity above 0.85: hot sauce, pickled peppers, pickles. The difference decides the paperwork. Acid foods aren't covered by FDA's acidified food rules; acidified foods are, and their makers register with FDA, file a scheduled process for each product and container size, work under someone who has attended an approved school, and keep pH records. Jams, jellies and preserves, carbonated drinks, and anything kept refrigerated all the way to the shopper are excluded. In the example below, a hot sauce maker sorts six products. Below are the definitions, what's excluded, what an acidified food maker does, and a free checklist.
The short version
- Acid food: natural pH 4.6 or below. Not covered by the acidified food rules.
- Acidified food: a low-acid food plus acid, finished pH 4.6 or below, water activity above 0.85.
- Low-acid food: finished pH above 4.6 and water activity above 0.85.
- Excluded: jams, jellies, preserves, carbonated drinks, acid dressings and sauces with a little low-acid food, and foods kept refrigerated to the shopper.
- Tomato products under pH 4.7 aren't low-acid.
- An acidified food maker registers with FDA within 10 days of starting, files each process within 60 days and before packing a new product, works under a trained supervisor, and keeps pH records.
- TaroStack keeps each batch's pH on its batch record, with its lot. More below.
The definitions
| Category | Definition | Examples |
|---|---|---|
| Acid food | A natural pH of 4.6 or below | Most fruits, vinegar, citrus juice, a raspberry shrub |
| Low-acid food | A finished pH above 4.6 and a water activity above 0.85 | Peppers, beans, cucumbers, most vegetables, meat, fish |
| Acidified food | A low-acid food with acid or acid food added; water activity above 0.85; finished pH 4.6 or below | Hot sauce from peppers and vinegar, pickled peppers, pickles |
All three are defined in 21 CFR 114.3, which also says what's left out: carbonated beverages; jams, jellies and preserves; acid foods, including dressings and condiment sauces, that contain small amounts of low-acid food and end at about the same pH as the acid in them; and foods stored, distributed and retailed under refrigeration. Tomatoes and tomato products with a finished pH under 4.7 aren't classed as low-acid. This is general information, not legal advice.
What an acidified food maker does
| Step | When | Rule |
|---|---|---|
| Register the establishment on Form FDA 2541 | Within 10 days of first making acidified foods | 21 CFR 108.25(c)(1) |
| File the scheduled process for each food and container size on Form FDA 2541e | Within 60 days of registering, and before packing any new product | 21 CFR 108.25(c)(2) |
| Work under a supervisor who has attended a school approved by FDA | Always | 21 CFR 114.10 |
| Follow the scheduled process and keep records, pH included | Every batch | 21 CFR part 114 |
The scheduled process comes from a process authority, who sets the pH limit and any heat step for each product. Filing it isn't FDA approval: FDA says so in the rule itself. How a process authority letter works is in process authority letter, and how to measure pH reliably in pH testing for acidified foods.
An example: six products, sorted
Blue Ridge Hot Sauce, a made-up hot sauce maker in Roanoke, Virginia, I use in these examples, sorts what it makes and what it's thinking of making:
| Product | Low-acid ingredient? | Acid added? | Finished pH | Water activity | Kept cold? | What it is |
|---|---|---|---|---|---|---|
| Original hot sauce | Yes: peppers | Yes: vinegar | 3.6 | 0.97 | No | Acidified food |
| Pickled jalapeños (planned) | Yes | Yes | 3.9 | 0.98 | No | Acidified food |
| Raspberry shrub | No | Vinegar | 3.1 | 0.93 | No | Acid food |
| Tart cherry preserves, from a neighbor | No | Lemon juice | 3.3 | 0.82 | No | Excluded: preserves |
| Fresh salsa, sold chilled | Yes | Yes | 4.2 | 0.98 | Yes | Excluded: refrigerated |
| Roasted pepper spread, no acid | Yes | No | 5.4 | 0.97 | No | Low-acid |
The hot sauce and the jalapeños bring the registration, the filed processes and the pH log. The shrub is an acid food: nothing in it is low-acid. The roasted pepper spread is the one to stop and think about: sealed and sold off the shelf, it would fall under the stricter low-acid canning rules, so Blue Ridge either adds acid under a new scheduled process or sells it refrigerated.
Each batch's pH goes in the log against the process limit, pH 4.0 in Blue Ridge's process. On October 9, the smoked habanero, lot L2610-04, read 4.08, over the limit, so the batch was held and the process authority called before any of it shipped. What a hot sauce business costs to start and run is in hot sauce business plan.
Get the checklist
Download the acid or acidified food checklist. Two sheets: which is it, one line for each product with yes or no for a low-acid ingredient, added acid, refrigeration and jam, and the finished pH and water activity, where FDA's category fills in; and a pH log, each batch's reading against your process limit with the meter's calibration and initials, red when over. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
A pH log in a binder records the reading. It doesn't stop a batch that read 4.08 from being packed into cases and put on Thursday's delivery, and it doesn't say which stores got lot L2610-04 if the hold came too late.
How TaroStack does it
TaroStack keeps each batch's pH on its batch record, with its lot.
pH on the batch record. Fields of your own on the batch record, numbers and initials, hold the pH reading, the meter calibration and who checked, and printable batch-record forms carry the same fields for the kitchen.
A hold that stops it shipping. A lot on hold is kept out of what can be sold, so lot L2610-04 waits for the process authority instead of going out on Thursday.
Lots to the store. Each batch records the lots of peppers and vinegar it consumed, and each order records the lots each customer got, so one recall report shows where a batch went.
| The job | Binder | In TaroStack |
|---|---|---|
| The pH reading | A line in a log | A field on the batch record |
| A batch over the limit | Remembered, hopefully | A hold on the lot |
| Which peppers went in | Not recorded | Recorded automatically |
| Which stores got a batch | Search the invoices | One recall report |
Batches, batch records with fields of your own, holds and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.