21 CFR Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

Part 117 of title 21 runs to 61 sections across 7 subparts, and sits in subchapter B, Food for Human Consumption. Every section is reproduced in full and is current to 2026-09-10.

Sections

61

Subparts

7

Words of regulation

22,854

Current to

2026-09-10

What this clause controls in practice

A food safety plan controls 22 hazards under 21 CFR part 117, and FDA food recalls name an undeclared allergen or an undeclared allergen or Listeria contamination or Listeria contamination or Listeria contamination or Salmonella contamination or Salmonella contamination or Salmonella contamination or foreign material or foreign material or foreign material or spoilage or spoilage or chemical contamination or chemical contamination or chemical contamination or E. coli contamination or E. coli contamination or an unapproved ingredient or a process deviation or viral or parasitic contamination or viral or parasitic contamination in 62,192 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.

• Undeclared allergens7,778Covered under 21 CFR 117.135(c)(2)
• Undeclared allergens7,778Covered under 21 CFR 117 subpart G
• Listeria monocytogenes7,493Covered under 21 CFR 117.135(c)(3)
• Listeria monocytogenes7,493Covered under 21 CFR 117.165(a)(3)
• Listeria monocytogenes7,493Covered under 21 CFR 117.150
• Salmonella3,642Covered under 21 CFR 117.135(c)(1)
• Salmonella3,642Covered under 21 CFR 117 subpart G
• Salmonella3,642Covered under 21 CFR 117.165(a)(2)
• Foreign material2,432Covered under 21 CFR 117.40
• Foreign material2,432Covered under 21 CFR 117.80(c)
• Foreign material2,432Covered under 21 CFR 117.150
• Spoilage and mould782Covered under 21 CFR 117.93
• Spoilage and mould782Covered under 21 CFR 117.80(b)(3)
• Chemical contamination607Covered under 21 CFR 117.35(b)
• Chemical contamination607Covered under 21 CFR 117 subpart G
• Chemical contamination607Covered under 21 CFR 117.130(b)(1)(ii)
• E. coli551Covered under 21 CFR 117.135(c)(1)
• E. coli551Covered under 21 CFR 117 subpart G
• Unapproved ingredients536Covered under 21 CFR 117 subpart G
• Process deviation306Covered under 21 CFR 117.150
• Viral and parasitic contamination303Covered under 21 CFR 117.10
• Viral and parasitic contamination303Covered under 21 CFR 117 subpart G

Recent records naming one of those hazards:

Read 21 CFR part 117 at the eCFR · All of 21 CFR for food safety

Questions

What does 21 CFR part 117 cover?

21 CFR part 117 is Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. It runs to 61 sections across 7 subparts and sits in subchapter B of chapter I, Food for Human Consumption.

Which hazards does 21 CFR part 117 control?

A food safety plan controls an undeclared allergen and an undeclared allergen and Listeria contamination and Listeria contamination and Listeria contamination and Salmonella contamination and Salmonella contamination and Salmonella contamination and foreign material and foreign material and foreign material and spoilage and spoilage and chemical contamination and chemical contamination and chemical contamination and E. coli contamination and E. coli contamination and an unapproved ingredient and a process deviation and viral or parasitic contamination and viral or parasitic contamination under part 117. Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.