Low-acid and acidified food imports
Canned and shelf-stable foods carry requirements most importers have never encountered — filed processes and establishment registration, both needed before arrival.
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Low-acid canned food and acidified food imports are subject to additional FDA requirements beyond ordinary food rules. Foreign processors must register the establishment and file scheduled processes for each product with FDA, and the resulting identifiers must be reflected in the entry. Shipments arriving without them are commonly held.
Key takeaways
- Foreign processors must register the establishment separately from ordinary facility registration.
- Scheduled processes must be filed for each product and container size.
- The resulting identifiers belong in the entry data.
- These requirements apply to the processor, but the importer bears the consequence.
- Registration and process filing take time and must precede shipment.
What the requirements are
Low-acid canned foods and acidified foods are regulated because of the botulism risk associated with improper processing. Foreign processors must register their establishment with FDA and file the scheduled process — the specific thermal or acidification treatment — for each product and container combination.
These are obligations of the processor, but a shipment held because they were not met is the importer's problem.
Why importers get caught
Almost always because nobody asked. The supplier may be entirely competent at making the product and unfamiliar with U.S. requirements. Confirming registration and process filing before the first order is far easier than resolving it with a container on the ground.
How it works
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01
Product category confirmed
Whether the food falls within low-acid or acidified definitions.
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02
Processor registration verified
Establishment registration confirmed as current.
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03
Process filings confirmed
Scheduled processes filed for the specific products and containers.
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04
Identifiers carried into the entry
Reflected in the entry data rather than omitted.
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05
Entry filed
With the full data set, and monitored on both sides.
Common mistakes
- Assuming ordinary facility registration covers it. Establishment registration is separate.
- Not asking the supplier before the first order. This is a pre-shipment question.
- Process filed for a different container size. Filings are product and container specific.
- Missing identifiers in the entry. Filed but not declared produces the same hold.
- Leaving it until arrival. Registration and filing take time you will not have.
Questions
What counts as a low-acid canned food?
Broadly, foods above a specified pH packaged in hermetically sealed containers and made shelf-stable through thermal processing. Acidified foods are low-acid foods to which acid is added to reduce pH. Whether a specific product qualifies depends on its formulation and processing.
Who has to register and file?
The foreign processor registers the establishment and files the scheduled processes. The importer does not file them, but bears the consequence at the border if they are missing.
How long does the process take?
Registration and process filing take time and must be completed before shipment. Build it into the purchasing timeline rather than the arrival timeline — this is not something that can be resolved while cargo waits.
What happens if a shipment arrives without them?
It is likely to be held pending resolution, and resolution means the processor completing requirements that take time. This is among the more difficult food holds to unwind quickly.
Related
Tell us what you're importing.
Commodity, origin, port and arrival date is enough to start.