US import compliance
Low-acid and acidified foods: the filings that decide whether a can clears
Two jars can hold the same fruit, from the same grove, in the same week, and require two entirely different registrations with the FDA. The dividing line is pH 4.6.
Last reviewed: 20 September 2026
01
Where the line falls
The FDA classifies canned products by finished equilibrium pH and water activity - not by what the product is called, and not by the container it is in.
| Category | Finished equilibrium pH | Water activity |
|---|---|---|
| Low-acid canned food | above 4.6 | above 0.85 |
| Acidified food | 4.6 or below | above 0.85 |
An acidified food is a low-acid food brought to pH 4.6 or below by adding acid or an acid food. A naturally acid food that was always below 4.6 is a third thing again, and sits outside both regimes. Alcoholic beverages are excluded.
Equilibrium pH, not the pH of the brine. The measurement that matters is the finished product at equilibrium, solid and liquid phases settled together. A brine testing below 4.6 on the filling line proves nothing if the drained fruit has not equilibrated to it.
02
A worked example: two olives
Olives make the point better than any diagram, because the same crop splits across both regimes depending on how it is processed.
| Preparation | Typical finished pH | US classification |
|---|---|---|
| Black olives, ripe-processed | 6.0 - 7.5 | Low-acid canned food - requires a full thermal scheduled process |
| Green olives, fermented or acidified | 3.0 - 4.0 | Acidified food - filed under the acidified regime |
Same fruit. Two regulatory paths, two process filings, two sets of records at the producing site. A buyer who orders both and assumes one filing covers the programme has a problem waiting at the port.
03
What the producing site must file
These obligations sit on the processor, including processors outside the United States who export there. They are separate from, and additional to, food facility registration.
| Step | What it is | When |
|---|---|---|
| FCE | Food Canning Establishment registration, on Form FDA 2541. Produces the establishment FCE number. | Not later than 10 days after first processing or packing such foods. |
| Process filing | The scheduled process for each product in each container size. Form FDA 2541e for acidified foods; Forms FDA 2541d, 2541f or 2541g for low-acid canned foods. | Before packing a new product, and no later than 60 days after registration. |
| SID | Submission Identifier - the date the filing form was created plus a sequence number, identifying that specific filing. | Issued with each process filing. |
Cited at 21 CFR 108.25(c)(1), 108.35(c)(1) and 108.35(c)(2).
An FCE number is not a pass. It says the establishment is registered. It says nothing about whether your product, in your container size, has a filed scheduled process. That is what the SID covers, and it is product-and-format specific. Ask for both.
04
What a buyer should check
- Which regime does this product fall under? Ask for the finished equilibrium pH, not a category name.
- FCE number for the producing site, and confirmation it is current.
- SID covering the exact product and container size. A change from a 400 g jar to an A10 tin is a different filing.
- Does the filing match the recipe actually shipped? A reformulation that shifts pH across 4.6 moves the product into the other regime entirely.
- Remember the FSVP overlap. Low-acid canned foods are exempt from FSVP for microbiological hazards only; every other hazard still requires a full FSVP file.
05
How we handle it
- Finished equilibrium pH published in the specification for every canned line, so the regime is unambiguous
- FCE and the process filing reference held per producing site, per product, per container format
- Format changes treated as a new filing question, not a packaging decision
- Filing status issued with the shipment document set
Source and scope
Source. 21 CFR Parts 108, 113 and 114, and the FDA published guidance on establishment registration and process filing for acidified and low-acid canned foods. Provisions are cited inline.
Scope. pH ranges shown for olives are indicative of typical preparations and are given to illustrate the classification test - they are not a specification. Classification for any given product follows its own measured finished equilibrium pH. General information for commercial importers, not legal advice; confirm current requirements with the FDA, your process authority and your customs broker.
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