The FCE and the process filing
Updated
Having a scheduled process is not the end of it. It has to be filed, and there are two separate registrations that people routinely conflate.
Two filings, not one
An FCE, the food canning establishment registration, on Form 2541. And a scheduled process filing on Form 2541e.
Generally: one establishment registration, plus a separate process filing for each product, process and container size.
So a producer with three sauces in two bottle sizes has one FCE and up to six process filings.
The FCE
Identifies the establishment where acidified foods are manufactured. It is administrative and it is free, and it is a prerequisite rather than an achievement.
Note that it attaches to the facility. If you move premises, or if a co-packer makes your product, the FCE position changes and needs attention.
The process filing
Submits the scheduled process for a specific product in a specific container, made by a specific process. It is what tells FDA how your product is rendered safe.
It comes from the process authority's document rather than from your own description, which is why the two steps happen in that order: process authority first, filing second.
Why container size appears
Because the container is part of the process. Fill temperature, cooling rate and the time to reach equilibrium pH all depend on the volume and geometry of what you filled.
A larger bottle cools more slowly and a wider mouth behaves differently, so a process validated for one is not automatically valid for another.
The practical consequence is that a new bottle size is a new filing, which makes packaging a regulatory decision here rather than a marketing one, and it is the strongest argument in this property for settling the container before anything else.