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:

ReportedProductFirmReasonClass
2026-08-26Organic Whole Mixed Berries, Net Wt. 48 oz (3Lb) plastic bag. packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12153Publix Super Markets, Inc.Due to potential E. coli O145:H28 contaminationClass I
2026-08-26Organic Whole Mixed Berries, Net Wt. 10 oz (284 g) plastic bags, packed in 8 bags per case of 10 oz each. Keep Frozen. UPC 41415-06753Publix Super Markets, Inc.Due to potential E. coli O145:H28 contaminationClass I
2026-08-26Organic Whole Blueberries, Net Wt 10 oz (284g) plastic bag, packed in 8 bags per case of 10 oz each. Keep Frozen UPC 41415-06453Publix Super Markets, Inc.Due to potential E. coli O145:H28 contaminationClass I
2026-08-26Organic Whole Blueberries, Net Wt. 48 oz (3Lb) plastic bag, packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12053Publix Super Markets, Inc.Due to potential E. coli O145:H28 contaminationClass I
2026-07-22Organic Whole Blueberries, Net Wt 10 oz (284g) plastic bag, packed in 8 bags per case of 10 oz each. Keep FrozenFrutas y Hortalizas del Sur S.A.Potential E. coli O145:H28 ContaminationClass I
2026-05-13RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENNET, CULTURES, KOSHER SEA SALT Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001184Raw Farm LLCMulti-state outbreak of E. coli O157:H7.Class I
2026-05-13RAW FARM SHREDDED RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204000194Raw Farm LLCMulti-state outbreak of E. coli O157:H7.Class I
2026-05-13RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz (454g) UPC: 835204000156Raw Farm LLCMulti-state outbreak of E. coli O157:H7.Class I

Subpart A: General Provisions

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 access

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.