US Food Safety

21 CFR Part 182 - Substances Generally Recognized as Safe

Plain-language explanation, inspection context and common violation patterns.

What it says

Part 182 lists substances that are generally recognized as safe, or GRAS, when used in food under the stated conditions, such as spices, seasonings, flavorings, preservatives and other common ingredients. A substance on the list may be used in accordance with good manufacturing practice, and the list is not exhaustive, since other substances can be GRAS based on scientific procedures or common use in food.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

GRAS status depends on the substance and the intended use, not just the substance.
Use must follow good manufacturing practice, so quantity should be limited to what is needed for the technical effect.
Manufacturers should keep the basis for their reliance on GRAS status.

What FDA inspectors look for

Whether the ingredient is listed or otherwise supported as GRAS for the use.
Whether usage levels are reasonable and consistent with good practice.
Whether the basis for GRAS status is on file.

Most common violation

A novel ingredient used on an assumption that it is GRAS with no supporting basis on file.

Related regulations

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