Low-acid canned foods (pH above 4.6, water activity above 0.85) fall under 21 CFR 113, and acidified ones (pH 4.6 or below) under 21 CFR 114. Processors of both register on Form 2541 within 10 days of starting and file each product's process, per container size, within 60 days of registration.
This guide is for QA and food safety managers who make canned, pouched or pickled products for the US, including plants in the Gulf.
Is your product low-acid canned, acidified or neither?
A low-acid food is any food, other than alcoholic beverages, with a finished equilibrium pH above 4.6 and water activity above 0.85 (113.3(n)). Tomatoes and tomato products below pH 4.7 are not low-acid. A low-acid canned food (LACF) is thermally processed to commercial sterility in a hermetically sealed container.
An acidified food is a low-acid food brought to pH 4.6 or below by adding acids or acid foods (114.3(b)). The rule's examples include beans, cucumbers, cabbage, peppers and fish, often sold as "pickles". Part 114 excludes carbonated beverages, jams, jellies and preserves, and foods kept under refrigeration through to retail. It also excludes acid dressings and sauces whose small share of low-acid food does not change the pH significantly.
The rule classifies by measured pH and water activity, not by product name, so a hummus or a chilli sauce needs test data first. A "Keep refrigerated" label is not a substitute for a process. FDA rejected it as a botulism control at a Kuwaiti aseptic dairy (see the border section below).
If you conclude a product is not acidified, you may register and submit Form 2541e voluntarily. FDA then says whether it agrees and shares the result with investigators and import reviewers. Our guides to Codex HACCP and pickle safety and pH cover the Codex side.
Why does a canner need two FDA registrations?
The first is the food canning establishment (FCE) registration on Form FDA 2541, under 21 CFR 108.35 for LACF and 108.25 for acidified foods. File it no later than 10 days after you start production. Each physical plant gets its own FCE number.
The second is food facility registration under section 415 of the FD&C Act. FDA's 2016 filing guidance says the two are different and canners need both. Food facility registration is renewed every even-numbered year between 1 October and 31 December, and a foreign plant names a US agent.
Foreign acidified food processors must register before any offering for import (108.25(c)(1)), and 108.35(k) applies the LACF section to foreign processors.
A January 2026 warning letter shows why the split matters. An Arkansas pickled quail egg processor held an FCE registration but had filed no scheduled process. It had also failed to renew its food facility registration for 2024, a prohibited act under section 301(dd).
What do you file with FDA, and by when?
No later than 60 days after registration, and before packing any new product, you file the scheduled process for each food in each container size. LACF uses Form FDA 2541d for retorted foods, 2541f for water activity or formulation control and 2541g for aseptic systems. Acidified foods use Form 2541e. Each filing gets a Submission Identifier (SID).
Filing is not approval. Sections 108.25 and 108.35 both say so, and FDA treats the filing duty as met on the date it receives a complete filing. FDA's 2016 guidance still footnotes the older Forms 2541a and 2541c, but the current eCFR names 2541d to 2541g.
For LACF, a change that lowers temperature or time, or changes formulation or container, needs substantiation by a qualified scientific authority before use, recorded and confirmed in writing by that authority. Send FDA a full description within 30 days after first use.
What do FDA investigators check in a canning plant?
The last column is what an investigator asks to see.
| Requirement | LACF (Part 113) | Acidified (Part 114) | Evidence |
|---|---|---|---|
| Plant registration | Form 2541, 10 days | Form 2541, 10 days. Foreign plants before import | FCE number plus food facility registration |
| Process filing | 2541d, 2541f or 2541g, 60 days | 2541e, 60 days | SID per product and container size |
| Who sets the process | Qualified persons (113.83) | Qualified person (114.83) | Process letter or study records |
| Supervisor training | Approved school (113.10) | Approved school (114.10) | School completion record |
| Key control | Time, temperature, critical factors, seams | Equilibrium pH 4.6 or below in the scheduled time | Retort charts, pH logs, meter calibration |
| Deviations | Reprocess or authority evaluation (113.89) | Reprocess, process under Part 113, or evaluation (114.89) | Separate deviation file |
| Records | Reviewed within 1 working day and before release. Kept 3 years | Kept 3 years | Signed, dated records |
| Part 117 | Exempt from subparts C and G for Part 113 microbiological hazards only, if Part 113 is met | No 117.5 exemption of its own | Food safety plan |
For LACF, temperature devices are tested against a traceable reference on installation and at least once a year. Visual top-seam checks should run no more than 30 minutes apart, and double-seam teardowns no more than 4 hours apart. For acidified foods with a finished pH above 4.0, pH is measured with a pH meter.
Records written after the event appear in two recent warning letters. In November 2025 FDA warned Yuyao City Boss Vegetable Factory in China, whose staff were seen backdating pH records for acidified mustard stems. In July 2026 it warned H2 BEV, LLC and H2 RENU, INC in Texas, which had no FCE registration, no filed process and pasteurisation logs filled in after processing.
The last table row is the trap. If it complies with Part 113, an LACF plant is exempt from Part 117 subparts C and G only for the microbiological hazards Part 113 controls (117.5(d)). Allergens and chemical and physical hazards still go through hazard analysis and, where needed, preventive controls. FDA's December 2021 guidance says acidified food processors have no exemption of their own from Part 117 and must meet every applicable section.
Who sets the process, and does the school certify anyone?
Industry calls the expert a "process authority", but Parts 108, 113 and 114 never use that phrase. They say "qualified persons" with expert knowledge (113.83), a "competent processing authority" (113.89, 114.89) and a "qualified scientific authority" for LACF process changes.
For acidified foods, the expert needs training and experience in acidification (114.83). FDA's January 2026 letter cited the Arkansas processor for having no process set by a qualified person, a repeat of a 2022 observation.
Operators work under a supervisor who attended a school the FDA Commissioner has approved (113.10, 114.10). The rules say the school identifies the person as having completed the course. The rules do not call this certification, and "Better Process Control School" is an industry name they never use.
A course alone fixes nothing. When H2 BEV answered FDA with one employee's school registration, FDA said it did not address the registration, filing and record failures.
What happens at the US border for a Gulf canner?
For foreign plants, FDA asks for refusal of admission instead of an emergency permit, and the food stays out until FDA finds the plant compliant (108.35(k), 108.25(j)). Import Alert 99-37 lets FDA detain LACF and acidified foods without physical examination when no scheduled process is filed.
A Kuwaiti dairy has been on that alert since 10 June 2025 for all its low-acid canned foods. After inspecting the aseptic plant, FDA found no filed scheduled processes and said a "Keep refrigerated" label is not an adequate control for C. botulinum. The alert reports no illness, recall or positive product test.
When this guide was checked in October 2026, Import Alerts 99-36, 99-37 and 99-38 listed no firm from the UAE, Saudi Arabia, Qatar, Bahrain or Oman. Lists change.
Your US importer cannot file for you. FDA's acidified and LACF page says importers and brokers do not register or file, but must make sure their processors have. Under the Foreign Supplier Verification Programs (FSVP) rule, an LACF importer verifies Part 113 compliance for microbiological hazards and runs a full FSVP for chemical and physical hazards. Expect requests for your FCE number, SIDs and processing records.
How AGS can help
Both kits are editable Word and Excel files. Neither contains scheduled processes, which come from your process authority.
- U.S. Low-Acid Canned Foods Management System (21 CFR 113 & 108.35): 235 documents, including a product classification decision framework, heat penetration and heat distribution study documentation modules, and a scheduled process register.
- U.S. Acidified Foods Management System (21 CFR 114): 193 documents, including an equilibrium pH monitoring procedure and a pH meter calibration SOP.
Frequently asked questions
What must be reported to FDA after a process deviation?
Report spoilage, a process deviation or microbial contamination of potential health significance promptly when an affected lot has entered distribution (108.35(d) and (e), 108.25(d)).
Do canned meat and poultry products follow these rules?
No. Neither 108.25 nor 108.35 applies to food processed under continuous USDA FSIS inspection.
Can canned seafood or juice fall under Part 113 too?
Yes. FDA's 2021 guidance says plants under seafood HACCP (Part 123) or juice HACCP (Part 120) may also be subject to Part 113.
Can LACF records be kept electronically?
Yes, if they comply with 21 CFR Part 11 (113.100(h)).
AGS provides independent documentation toolkits. This guide and the referenced kits are not affiliated with, endorsed by or approved by the US Food and Drug Administration. It is general information, not legal advice. Classification depends on your product's pH, water activity, storage and formulation.
Reviewed October 2026. Facts checked against the sources current at publication.
