21 CFR Part 109: Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material
Part 109 of title 21 runs to 7 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
- 7
- Subparts
- 2
- Words of regulation
- 3,289
- Current to
- 2026-09-10
Subpart A: General Provisions
- 109.3 Definitions and interpretations5
- 109.4 Establishment of tolerances, regulatory limits, and action levels5
- 109.6 Added poisonous or deleterious substances11
- 109.7 Unavoidability2
- 109.15 Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials8
- 109.16 Ornamental and decorative ceramicware9
Subpart B: Tolerances for Unavoidable Poisonous or Deleterious Substances
Read 21 CFR part 109 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 109 cover?
- 21 CFR part 109 is Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material. It runs to 7 sections across 2 subparts and sits in subchapter B of chapter I, Food for Human Consumption.
Every section of part 109 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.
Early accessRecall 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.