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Does this product fit the category?
21 CFR 114.3 distinguishes acidified foods from naturally acid foods and stated exclusions using actual formulation, water activity (available moisture), finished equilibrium pH (finished acidity) and storage/process facts. Refrigeration and other exclusions matter.
A qualified food/process lead needs those facts. Informal acidity measurement does not establish a safe or lawful shelf-stable process, and not every sauce or pickle takes the same route.
What is registered, and what is filed?
For covered activity, 21 CFR 108.25 separates U.S. establishment timing tied to first engaging in the activity, foreign registration before offering foods for import, and the scheduled-process filing for the actual food/container. Apply the actual timing, including filing before packing a new product.
A scheduled process concerns the selected process and critical factors for that food. Filing is expressly not FDA approval. General food-facility registration does not replace the product/container process information.
The actual processor must also meet applicable process adherence, trained operating supervision, records and recall duties. A co-packer agreement should identify who does that continuing work; agreeing a production price does not settle it.
Scope
- Limited federal acidified-food scope. Detailed §114.83 process requirements were not fully reviewed; no recipe/validation, import/FSVP/prior-notice, label or commodity/state-local approval is established.
Next step
Obtain the actual product-category and process answer before treating a registration or filing number as readiness to pack.
Sources & review notes
U.S. Food and Drug Administration
Passage, dates and research notes
primary · Acid/acidified food, exclusions and scheduled process
low-acid foods to which acid(s) or acid food(s) are added
Complete current section read. Water activity, finished equilibrium pH, naturally acid foods, listed exclusions/refrigeration and competent-process concept distinguish the named category. A sauce name, vinegar ingredient or one informal pH reading does not establish regulatory classification. Section 114.83 follow-up fetch failed with HTTP 503; no claim to have reviewed that separate section.
U.S. Food and Drug Administration
Passage, dates and research notes
primary · Paragraphs (c),(e),(f),(g),(h),(j)
Filing of this information does not constitute approval of the information by the Food and Drug Administration
Full current section read. Distinguishes U.S. registration timing, foreign registration before import offering, scheduled-process filing by product/container, trained operating supervision and records/recall plan. USDA-continuous-inspection exception retained. Does not grant food approval or replace other facility/import rules.
Detailed rule records (2)
114.3 distinguishes acidified low-acid foods with defined water-activity/equilibrium-pH conditions and exclusions from naturally acid or refrigerated foods. Classify the actual product before applying 108.25 rather than relying on a sauce/pickle marketing name.
21 CFR 114.3: Definitions108.25 distinguishes establishment registration, product/container scheduled-process filing, trained operating supervision, process adherence and records/recall procedures. It expressly says filing is not FDA approval; U.S. first-engagement and foreign-import-offering timing differ.
21 CFR 108.25: Acidified foods 21 CFR 114.3: DefinitionsKeep this reading in your learning library.
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