21 CFR Part 120 requires juice processors in the US and abroad to write a hazard analysis and, where a hazard is reasonably likely, a HACCP plan. Unless exempt, the plan must achieve a 5-log reduction in the pertinent microorganism, a rule in force since 22 January 2002.
This guide is for QA managers at juice plants, including Gulf exporters, and their US importers.
Who counts as a juice processor, and where does retail stop?
Part 120 covers juice sold as such or used as an ingredient in beverages, whether or not it crosses a state line. Juice includes purées and concentrates. A processor is anyone making juice commercially, to order or in an institution, in the US or in a foreign country. The rule bound small businesses from 21 January 2003 and very small businesses from 20 January 2004, so size no longer exempts anyone.
Operating a retail establishment is not processing. Retail means providing juice directly to consumers only. An outlet that also sells juice to other businesses is not a retail establishment, so a single wholesale customer makes you a processor.
FDA's Juice HACCP and FSMA guidance of December 2021 gives two examples. A central kitchen that sells to consumers and supplies its own outlets is exempt from Part 120, but may still need to register and follow Part 117. A caterer selling juice to an airline is covered.
Retail does not escape the label rule for packaged juice. Untreated juice in a labelled package must carry FDA's warning that it is unpasteurised and may contain harmful bacteria (21 CFR 101.17(g)), even when a retailer packs it. FDA does not require the warning on juice sold by the glass. A juice bar selling only in the Gulf is outside Part 120 altogether.
How does the 5-log rule work, and who is exempt?
Section 120.24(a) requires controls that consistently give at least a 5-log reduction in the pertinent microorganism for at least the shelf life, under normal and moderate abuse storage. That is the most resistant microorganism of public health significance likely to occur in the juice. FDA's 2004 Hazards and Controls Guidance gives E. coli O157:H7 as an example. For low-acid juices such as carrot juice, it describes a step that destroys non-proteolytic C. botulinum spores.
Two groups are exempt from the 5-log paragraph. One is juice processed under Part 113 (low-acid canned foods) or Part 114 (acidified foods). The other is a processor using a single thermal step that makes the juice shelf-stable, or a thermal concentration process that treats all ingredients, with the thermal process filed in the hazard analysis.
The treatment must be applied to the juice itself, except for citrus. A citrus processor may treat the fruit surface instead, after culling and cleaning. Either way, the 5-log step and final packaging must happen in one facility.
Because surface treatment does not reach all the juice, section 120.25 requires testing for biotype I E. coli. You take one 20 mL sample, as two 10 mL subsamples, per 1,000 gallons produced each day, from consumer-ready packages of each juice. A plant making less still tests at least once every 5 working days.
One positive means reviewing the 5-log monitoring records and correcting the cause. Two positives in a series of seven tests mean the controls are deemed inadequate. You must then switch at once to a process that achieves 5-log after extraction, until the problem is corrected.
What does FDA ask to see at a juice HACCP inspection?
Part 120 asks for sanitation standard operating procedures (SSOPs), a written hazard analysis for each juice type and, where a hazard is reasonably likely, a written HACCP plan. FDA says the SSOPs need not be written, but their monitoring and correction records must be. Without a compliant system, the juice is adulterated (120.9).
| Part 120 requirement | What FDA asks to see | Section |
|---|---|---|
| Hazard analysis | One per juice type, signed by the most responsible person onsite | 120.7, 120.12(c) |
| HACCP plan | One per location and juice type, with CCPs, critical limits, monitoring and corrective actions | 120.8 |
| 5-log control | Validation data for that juice and that equipment | 120.24(a) |
| Citrus surface treatment | E. coli test log and action on positives | 120.24(b), 120.25 |
| Sanitation | Monitoring records for the eight SSOP areas | 120.6 |
| Record review | CCP and corrective action records signed within 7 days | 120.11(a) |
| Validation | At least yearly, and after any relevant change | 120.11(b) |
| Retention | 1 year refrigerated, 2 years or shelf life if longer for frozen or shelf-stable | 120.12(d) |
| Importer verification | Written affirmative steps, records in English | 120.14 |
If you already run a Codex HACCP system, check it against each row of the table. Part 120 sets the 5-log target, the 7-day review and the retention periods as fixed numbers.
Does a Part 120 plant also follow Part 117?
It follows some of it. Section 120.5 applies the CGMP rules of Parts 110 and 117. Under 117.5(c), subparts C (preventive controls) and G (supply-chain program) do not apply to activities under Part 120, provided you comply with it.
FDA's December 2021 guidance sets out the rest. Subparts A, B and F still apply, so workers and supervisors need food hygiene training under 117.4, with records. Part 117 does not require a Part 120 plant to run environmental monitoring or keep a written recall plan.
Juice beverages or cocktails made in the same plant but outside Part 120 fall under full Part 117, unless another exemption applies. A certificate to a voluntary scheme such as ISO 22000:2018 does not replace the Part 120 plan FDA inspects.
What will a US importer ask a foreign juice plant for?
Section 120.14 puts the duty on the importer: the US owner or consignee at entry, or the US agent of a foreign owner. Unless the juice comes from a country with an FDA equivalence agreement, the importer keeps written "affirmative steps". It may:
- obtain your HACCP plan and the lot's SSOP records
- hold a certificate from a foreign government authority or competent third party
- inspect your plant regularly
- keep an English copy of your hazard analysis and plan with a written guarantee
- test periodically with a written guarantee
- use equivalent measures.
FDA notes that, as of October 2023, no foreign government was providing lists of processors in good standing.
The Foreign Supplier Verification Program (FSVP) rule does not apply to juice from a supplier that complies with Part 120 (1.501(b)). FDA's guidance tells these importers to file the code FSX for each entry, and an entry with no code is rejected.
For a Gulf exporter, that means 120.14 requests in English, not an FSVP questionnaire. A juice drink outside Part 120 goes back under Part 117 and FSVP. Your plant also registers with FDA and names a US agent, renewing between 1 October and 31 December of each even-numbered year.
Why has FDA detained or warned juice processors since 2024?
Import Alert 20-07 lets FDA detain juice from non-compliant foreign processors without physical examination. Frozen raw dragon fruit juice from Taiwan, listed on 13 March 2026, had no 5-log control of C. botulinum. A Turkish lemon juice from concentrate, listed on 29 April 2025, lacked 5-log control of Listeria monocytogenes.
No firm from the six GCC states was on the list when this guide was checked.
The 2024 warning letters show two failures: the wrong pertinent microorganism and no validation. FDA told G.N.R. Group (Thailand, 17 April 2024) that for frozen coconut juice, a low-acid juice, the target is non-proteolytic C. botulinum. Its pasteurisation limits could not deliver 5-log.
Raya Green Coconut (Thailand, 21 June 2024) left C. botulinum out of its coconut water plan and had no validation data. Thuan Thien (Vietnam, 29 March 2024) cited a literature article that did not cover its juices, which FDA did not accept. At Barsotti Juice Company (California, 30 January 2024), the carrot juice pasteurisation limit did not destroy C. botulinum spores.
How AGS can help
The U.S. Juice HACCP Management System (21 CFR 120) has 297 documents in editable Microsoft Word and Excel. It includes a Part 120 compliance matrix, a hazard library, a 5-log validation module, a citrus E. coli testing procedure for 120.25, an importer verification procedure and a retail versus wholesale decision model. It contains no registration procedure or FSVP programme.
Frequently asked questions
Does a juice HACCP plan need a certified author?
No. Section 120.13 asks for training at least equivalent to an FDA-recognised standardised curriculum, or equivalent job experience. The trained person need not be your employee.
Which edition of FDA's juice HACCP guidance is current?
The Hazards and Controls Guidance is still the First Edition of March 2004, and FDA lists no second edition. FDA's web page for that guidance reverses the first and last effective dates, so rely on the eCFR.
What lead, arsenic and patulin levels apply to juice?
FDA considers action on apple juice at 50 µg/kg patulin and has a final 10 ppb action level for inorganic arsenic in apple juice (June 2023). For lead, the 50 ppb level in the 2004 Hazards Guidance still applies. An April 2022 draft would replace it with 10 ppb for apple juice and 20 ppb for other single-strength juices.
AGS provides independent documentation toolkits. This guide and the referenced kit are not affiliated with, endorsed by or approved by the US Food and Drug Administration. It is general information, not legal advice. Whether Part 120 applies depends on your product, sales channel and process.
Reviewed October 2026. Facts checked against the sources current at publication.
