GMP & Compliance
GRAS review and ingredient classification
How Crown helps you match ingredients against FDA reference data and record a GRAS classification, and why the determination stays yours.
Crown can help you record a GRAS classification for each ingredient by matching it against published FDA reference data and surfacing possible matches for you to review. The work happens in two places: the GRAS review screen, which triages all your unclassified ingredients at once, and the GRAS substantiation section on each ingredient, where the classification is recorded.
The GRAS review screen
Open Food Safety, then GRAS review. Crown groups your unclassified ingredients by what its matcher found against the FDA reference data, so you can work through them quickly:
- Ingredients with a suggested explicit or conditional listing, each shown with the citation and a confidence level.
- Ingredients that look like candidates for a historical-use pathway.
- Ingredients with no match, to classify manually.
For each suggested match you can Accept it (which records the citation against the ingredient) or Reject it. Ingredients without a match link straight to the ingredient so you can classify them yourself.
Classifying an ingredient
You can also classify an ingredient directly from its drawer, in the GRAS substantiation section. If Crown found a match, it appears here as a suggested match with its citation and confidence, and you can Accept or Reject it. To record a classification yourself, set:
- Classification: Not classified, GRAS affirmed, GRAS self-determined, or Not GRAS.
- Pathway: the basis for the classification. The options are 21 CFR §182 (explicit listing), §184 (explicit affirmation), §172 (conditional approval), §170.30(c) (historical use pre-1958), and self-determined. Crown asks you to select a pathway for any classification other than "Not classified."
- Basis and notes: a free-text justification (some pathways ask for one) and any supporting notes.
Choose the classification and pathway that reflect your own determination for that ingredient. Crown records what you select and surfaces it in inspector-facing views; it doesn't choose for you.
Keeping the reference data current
The GRAS review screen shows when the FDA reference data was last refreshed and lets you rescan your unclassified ingredients against it. If the data is stale, a banner offers to refresh it. Rescanning re-checks only ingredients that aren't yet classified; it never changes a classification you've already recorded.
What's next
Ingredient classifications feed the chemical-and-ingredient picture behind your plan. See Setting up your ingredients for the rest of the ingredient record, and Hazard analysis and preventive controls for the product-level food safety work.
Frequently asked questions
Do I need to work through GRAS if I only sell in Canada?
GRAS is a US FDA concept, so it isn't aimed at CFIA-only operations. Some Canadian makers use the GRAS review as a reference point on their ingredients, and anyone planning to export to the US tends to work through it ahead of shipping. Whether it's relevant is your call based on where you sell.
What does accepting a suggested match do?
It records the FDA citation against that ingredient. Accepting is you confirming the match, not Crown deciding it, so review the citation and the confidence level first, and treat a low-confidence match as a prompt to look more carefully.
What if an ingredient has no match?
You classify it yourself from the ingredient's GRAS substantiation section, as self-determined, not GRAS, or not applicable. Crown records what you choose; the determination stays yours as the operator.