21 CFR Part 120 - Hazard Analysis and Critical Control Point Systems for Juice

What it says

Processors of juice and juice products must develop and implement a HACCP system that includes a hazard analysis, critical control points, monitoring, corrective actions, verification and records, and must include controls that achieve a 5-log reduction, for at least the pertinent microorganism, in the juice they process. Processors of certain citrus juices may achieve this through treatment of the fruit surface. Retail establishments that sell directly to consumers are generally outside the rule.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The 5-log reduction performance standard is the center of juice safety, so the validation of the process step that achieves it matters.
• Unpasteurized juice is a recognized higher-risk product, and its labeling and process controls are part of the same framework.
• Like seafood, juice has its own HACCP rule in addition to the general Part 117 requirements.

What FDA inspectors look for

• Whether the process is validated to achieve the required pathogen reduction.
• Whether monitoring of the critical control point is done as the plan requires.
• Whether records and corrective actions are complete.

Related regulations