21 CFR Part 120: Hazard Analysis and Critical Control Point (HACCP) Systems
Part 120 of title 21 runs to 15 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
- 15
- Subparts
- 2
- Words of regulation
- 5,733
- Current to
- 2026-09-10
What this clause controls in practice
A food safety plan controls one hazard under 21 CFR part 120, and FDA food recalls name E. coli contamination in 551 enforcement records since 2012. That is where the clause belongs, not a finding against any firm named below: a recall record states a reason, and most FDA food recalls are initiated by the firm itself.
Recent records naming one of those hazards:
Subpart A: General Provisions
- 120.1 Applicability4
- 120.3 Definitions21
- 120.5 Current good manufacturing practice1
- 120.6 Sanitation standard operating procedures12
- 120.7 Hazard analysis19
- 120.8 Hazard Analysis and Critical Control Point (HACCP) plan14
- 120.9 Legal basis1
- 120.10 Corrective actions11
- 120.11 Verification and validation14
- 120.12 Records25
- 120.13 Training6
- 120.14 Application of requirements to imported products15
Subpart B: Pathogen Reduction
Read 21 CFR part 120 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 120 cover?
- 21 CFR part 120 is Hazard Analysis and Critical Control Point (HACCP) Systems. It runs to 15 sections across 2 subparts and sits in subchapter B of chapter I, Food for Human Consumption.
- Which hazards does 21 CFR part 120 control?
- A food safety plan controls E. coli contamination under part 120. Juice HACCP: the hazard analysis and critical control point system required for juice processors, including a treatment achieving a 5-log pathogen reduction.
Every section of part 120 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.