The short answer
Two numbers decide which FDA canning rules apply to a shelf-stable food in a sealed container: its finished equilibrium pH and its water activity.
| Type | Definition | Main rule |
|---|---|---|
| Low-acid canned food (LACF) | Finished equilibrium pH above 4.6 and water activity above 0.85 (alcoholic drinks excluded; tomatoes and tomato products with pH below 4.7 excluded) | 21 CFR part 113 — a validated thermal process (retort or aseptic) |
| Acidified food (AF) | A low-acid food with acid or acid food added, so the finished equilibrium pH is 4.6 or below, with water activity above 0.85 | 21 CFR part 114 — pH control plus a scheduled process |
| Acid food | A food that is naturally at pH 4.6 or below (for example many fruits) | Not covered by parts 113/114, but general food rules apply |
Both LACF and acidified food processors must register the canning establishment (FCE) and file a scheduled process (SID) for each product under 21 CFR part 108 — including foreign processors that ship to the U.S.
Why the difference matters
Low-acid foods in sealed containers can support Clostridium botulinum, which produces a deadly toxin. FDA’s rules control this risk in two ways:
- LACF rely on heat — a process established by a qualified process authority that destroys spores, run on equipment that meets part 113.
- Acidified foods rely on acid — getting the whole product to pH 4.6 or below quickly and keeping it there, with a heat step to control other spoilage organisms.
Getting the classification wrong means the wrong controls — and at the border, it means detention. FDA refusal charges such as “NEEDS FCE” and “NO PROCESS” are among the common reasons canned and bottled foods are refused.
Common products and where they usually fall
| Product | Usually | Why |
|---|---|---|
| Canned beans, corn, coconut milk, tuna | LACF | Naturally low-acid, no acid added |
| Pickled vegetables, peppers in brine, many chutneys and pastes | Acidified | Low-acid vegetables with vinegar or acid added |
| Mango pulp with added citric acid | Depends on test results | Some varieties are naturally above pH 4.6; adding acid to bring them down makes them acidified |
| Jams, jellies and preserves (standardized) | Excluded from part 114 | Covered by their own standards |
| Naturally fermented pickles, carbonated drinks, refrigerated products | Excluded from part 114 | Specific exclusions in the acidified food rule |
What both types need for the U.S.
- 1FCE registration (Form FDA 2541)Registers the canning establishment. This is separate from, and in addition to, the regular FDA food facility registration.
- 2Process filing (SID)A filing for each product, style, container size and type, and processing method — on Form FDA 2541e for acidified foods, and the other 2541-series forms for LACF processes. FDA recommends filing electronically.
- 3A process authorityThe scheduled process must be established by a qualified person with expert knowledge of thermal processing or acidification.
- 4Trained supervisionOperations must be supervised by someone who has completed an FDA-recognized training course (commonly called Better Process Control School).
- 5RecordsProcessing, pH and container-closure records, kept and available for FDA review.
Importers, distributors and brokers do not register as canning establishments, but they must make sure the processors they buy from are registered and have filed. U.S. importers also need an FSVP; one 2026 FSVP warning letter cited an importer for not verifying that canned low-acid foods were made under part 113.
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Example: roasted peppers from Spain
Roasted red peppers are naturally low-acid. Packed in a vinegar brine to pH 4.2, they are an acidified food: the Spanish packer needs an FCE number, an SID filed on Form 2541e, and trained supervision. Packed in plain water and retorted instead, they would be a low-acid canned food needing a part 113 thermal process and a different process filing.
FCE registration $550. SID process filing $350 per product. Food facility registration with U.S. Agent from $300.
Frequently asked questions
What pH makes a food low-acid?
A finished equilibrium pH above 4.6, with water activity above 0.85. Tomatoes and tomato products with a finished pH below 4.7 are excluded from the low-acid definition.
Is a pickle an acidified food?
Usually yes, if low-acid vegetables are brought to pH 4.6 or below by adding vinegar or acid. Naturally fermented pickles are excluded from the acidified food rule.
Do I need both FCE and food facility registration?
Yes. The FCE registration covers canning; the food facility registration is a separate requirement for facilities that make food for U.S. consumption.
Do importers need an FCE number?
No. Importers, distributors and brokers are not required to register as canning establishments, but they must ensure the processors they represent comply.
Sources
- FDA — Acidified & Low-Acid Canned Foods: guidance documents and regulatory information
- FDA warning letter CMS 734615 (July 20, 2026) — FSVP verification for low-acid canned foods
- FDA — Import Refusals
Definitions and requirements checked against FDA sources on November 11, 2026. This article is general information, not legal advice.