What a process authority does
Every shelf-stable acidified food is made by a scheduled process: the recipe and steps that keep harmful microorganisms from growing in the closed jar. FDA doesn't let the processor guess. The process has to come from someone with real training and experience in acidification.
The regulation's definition of a scheduled process uses the other name you will hear, competent processing authority:
- Reviews your formula, ingredients, container and filling method
- Sets the critical factors: finished equilibrium pH, and as needed heat treatment, salt, sugar and preservative levels
- Puts the process in writing, so it can be attached to the FDA filing
- Evaluates product that went wrong during production, when a batch has to be set aside
Acidified foods: do you need a process authority?
You need one when your product is an acidified food made by a commercial processor. FDA's definition starts with low-acid foods and adds acid to them:
On top of that, the food's water activity is greater than 0.85 and its finished equilibrium pH ends at 4.6 or lower. The same definition leaves several foods out:
| Product | Covered by the acidified food rules? |
|---|---|
| Pickled cucumbers or pickled cauliflower on a store shelf | Yes |
| Shelf-stable salsa made from tomatoes, peppers and onions with vinegar | Usually: ask a process authority |
| Shelf-stable pickled peppers or vinegar pepper sauce | Yes |
| Jams, jellies and preserves | No, excluded by name |
| Carbonated beverages | No, excluded by name |
| Foods kept cold in storage, distribution and retail | No, excluded |
| Naturally acid foods (natural pH at or under 4.6) | No, they are acid foods, not acidified |
| Dry seasonings and powders | No, when water activity is 0.85 or lower |
Tomatoes sit on the line. FDA doesn't count tomatoes and tomato products with a finished equilibrium pH below 4.7 as low-acid foods, but the peppers, onions and garlic in a salsa are low-acid. That mix is exactly the kind of question a process authority answers for your recipe.
The FDA steps after the process is set
| Step | What happens | Rule |
|---|---|---|
| Food facility registration | The plant registers as a food facility and lists itself as an acidified food processor | 21 CFR 1.225 · 1.232 |
| Establishment registration | Form FDA 2541, within 10 days of starting to make acidified foods. The plant gets an FCE number | 21 CFR 108.25(c)(1) |
| Process filing | Form FDA 2541e per product and per container size: at the latest 60 days after registration, and always before a new product is packed. Each filing gets a SID | 21 CFR 108.25(c)(2) |
| Trained supervision | Production staff are supervised by someone who passed a course at a school FDA approved, covering pH controls and critical factors in acidification | 21 CFR 108.25(f) · 114.10 |
| Production | Reach pH 4.6 or lower within the time the process sets, test and record it, and code every container | 21 CFR 114.80 |
| Records | Processing, pH, deviation and distribution records kept for 3 years | 21 CFR 108.25(g) · 114.100 |
FDA's draft guidance on acidified foods notes that the approved course is often referred to as Better Process Control School. The draft is non-binding, but that is the name you will see when you look for a course.
The FDA filing records the process. It doesn't approve it. Responsibility for a safe process stays with the processor and the process authority behind it.
FCE number and SID: the two numbers you'll hear
The FCE (Food Canning Establishment) number identifies the plant. You get it when the plant registers on Form FDA 2541. The SID (Submission Identifier) identifies one process filing. FDA's system assigns it from the date the filing form was created plus a sequence number, so two filings made on the same day still get different SIDs.
In practice: one sauce in a 5 fl oz bottle and the same sauce in a 12 fl oz bottle are two filings with two SIDs. When you hire a co-packer for an acidified food, ask for the plant's FCE number and the SID for your product in your container size.
How to find a process authority
FDA's filing form asks who the process source is, and its instructions show who that can be. A plant may establish the process itself if it has the expertise, or use an outside organization, individual or university, or a published reference.
- Ask your state's agriculture or health department who they work with. New Mexico's environment department, for example, names the NMSU Food Safety Laboratory as a process authority that home producers can ask whether a recipe needs refrigeration
- Ask the co-packer you plan to use: many already work with a process authority
- Bring your exact formula by weight, your container and fill method, and how you plan to sell it
- Expect a written process document you can attach to the Form FDA 2541e filing
- Go back to the process authority before you change the recipe, the container or the method
When a batch misses the process
If a run drifts from the scheduled process or the finished pH ends up above 4.6, the processor has three choices: fully reprocess it by a process a competent processing authority set, process it as a low-acid canned food, or set it aside for evaluation. That evaluation is also the process authority's job, and food that isn't shown to be safe is reprocessed or destroyed.
When a lot that left the plant shows spoilage, a process deviation or contamination that could harm health, the processor must report it to FDA promptly. The lot code on every container is what makes that lot traceable.
Cottage food makers and acidified foods
Pickles, salsa and hot sauce made at home fall under your state's cottage food law, if that law allows them at all. States differ a lot here: some allow acidified foods with extra steps, others leave them out. Check your state page before you print a single label.
Cottage food law in every state →The label on an acidified food
The process authority keeps the jar safe. The label still has to follow the general FDA rules: product name, net quantity, ingredients in descending order by weight, allergens, your name and place of business, and in most cases Nutrition Facts. The serving size comes from FDA's reference amounts:
| Product | Reference amount | Label serving size |
|---|---|---|
| Hot sauce | 1 tsp | 1 tsp (5 mL) |
| Salsa | 2 tbsp | 2 tbsp (__ g) |
| Pickles and pickled vegetables | 30 g | 1 oz (28 g/visual unit of measure) |
| Pickle relish | 15 g | __ tbsp (__ g) |
Our tool calculates that panel from your recipe, using USDA ingredient data and FDA's rounding rules, writes the ingredient list and the Contains line, and gives you a print-ready PDF and a calculation report. It doesn't measure pH or set a process: that stays with your process authority.
Hot Sauce Label Requirements →Pickle Label Design →Start your label free →