What does 21 CFR part 186 cover?

21 CFR part 186 is Indirect Food Substances Affirmed as Generally Recognized as Safe. It runs to 16 sections across 2 subparts and sits in subchapter B of chapter I, Food for Human Consumption.

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21 CFR Part 186: Indirect Food Substances Affirmed as Generally Recognized as Safe

Part 186 of title 21 runs to 16 sections across 2 subparts, and sits in subchapter B, Food for Human Consumption. Every section is reproduced in full and is current to 2026-09-10.

Sections: 16
Subparts: 2
Words of regulation: 2,618
Current to: 2026-09-10

Subpart A: General Provisions

186.1 Substances added indirectly to human food affirmed as generally recognized as safe (GRAS)8

Subpart B: Listing of Specific Substances Affirmed as GRAS

Read 21 CFR part 186 at the eCFR · All of 21 CFR for food safety

Questions

What does 21 CFR part 186 cover?: 21 CFR part 186 is Indirect Food Substances Affirmed as Generally Recognized as Safe. It runs to 16 sections across 2 subparts and sits in subchapter B of chapter I, Food for Human Consumption.

Every section of part 186 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

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Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.