GRAS list and FDA databases for checking ingredient status
There is no single FDA GRAS list. Check the GRAS Notice Inventory and CFR listings, then match the ingredient's intended use and FDA correspondence.
There is no single, complete FDA GRAS list. Start with the GRAS Notice Inventory, then check the relevant provisions in Parts 182, 184 or 186 for your intended use.
GRAS means "generally recognized as safe." It applies to an intended use, not every possible use of an ingredient. Section 170.30 sets that standard. It also says Parts 182, 184 and 186 do not list every substance that is GRAS for its intended use in food. Absence from the inventory or those parts does not, by itself, show that a use is prohibited.
Where to find the FDA GRAS list
Choose the source that matches the question. An inventory record and a regulatory listing tell you different things.
| Source | What it tells you | What to check |
|---|---|---|
| GRAS Notice Inventory | Filed notices, intended conditions of use, and links to FDA letters | The notice and response letters, not just the ingredient name |
| 21 CFR Part 182 | Listed GRAS substances for stated purposes | Applicable limitations and good manufacturing practice |
| 21 CFR Part 184 | Direct human food ingredients FDA affirmed as GRAS | Prescribed purposes and conditions |
| 21 CFR Part 186 | Indirect human food ingredients affirmed as GRAS | It does not authorize direct addition to food |
The inventory includes all filed notices since 1998, whether pending or closed, and regardless of FDA's response. It is a notice database, not an approved-ingredients list.
Other lawful routes also exist. Part 172 covers permitted direct food additives, while Part 173 covers secondary direct food additives. Their specific provisions and use conditions need a separate check. And Part 189 is only a partial list of substances prohibited from use in human food. Absence is not permission.
The Substances Added to Food inventory, formerly EAFUS, is also partial. It includes prohibited or formerly used substances and generally excludes GRAS Notice Inventory entries. FDA also states that inclusion of independent FEMA information does not indicate FDA approval or evaluation.
How to check GRAS status for your use
A name match is only the start. Part 184 sets conditions and addresses uses that differ significantly from those covered.
For a supplier or formulation review:
- Identify the ingredient and applicable specifications.
- Record the intended food category, function, and use level.
- Ask which provision, notice or independent GRAS assessment supports the supplier's claim.
- Compare your proposed use with the actual listing or assessment and read all FDA correspondence.
This is a practical review checklist, not a separate statutory procedure. Don't assume every supplier must have a GRAS notice number.
Read the response itself. FDA's notification program explanation distinguishes three outcomes:
- FDA has no questions about the basis for the GRAS conclusion.
- FDA finds an insufficient basis for the GRAS conclusion.
- FDA ceases evaluation at the notifier's request.
The latter two are not favorable no-questions outcomes. Cessation alone establishes neither safety nor illegality. A no-questions letter concerns the basis for the GRAS conclusion, not blanket food-additive approval. Check later correspondence too. Section 170.265 provides for subsequent FDA letters when circumstances warrant.
Does self-affirmed GRAS mean FDA approval?
No.
An independent conclusion is not FDA approval. It must meet the substantive GRAS standard, including general recognition among qualified experts. For scientific-procedure GRAS, the evidence must meet the same quantity and quality standard as food-additive approval, and a company's assertion alone is not enough to show general recognition.
FDA published a proposal to require GRAS notification in August 2026. That proposal does not itself establish an effective requirement. Check current FDA rules before relying on an unnotified conclusion.
For Great Britain, a US GRAS conclusion is not a substitute for checking the applicable food-additive authorization and its use conditions. RegAffairs AI explains the US distinctions in its answer to where to find the FDA GRAS list.