Substantive source review: October 7, 2026. Juice HACCP is a system of hazard analysis, implemented controls and retained evidence. FDA does not routinely approve a processor’s HACCP plan or juice product. A facility registration or shipment filing does not establish HACCP compliance.
First establish the product and activity
Part 120 covers juice sold as juice or used as a beverage ingredient, including fruit or vegetable liquids, edible purees and concentrates. For diluted juice drinks, the juice ingredient must be produced under Part 120; the finished diluted beverage is not automatically subject to the same rule. Juice intended only for non-beverage foods, such as a candy ingredient, is outside this beverage-use scope. Raw agricultural ingredients are not themselves subject to Part 120. Other food-safety rules can still apply. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120/subpart-A/section-120.1
The defined retail establishment provides juice directly to consumers and does not sell or distribute it to other business entities as well. Its operation is excluded from Part 120 processing. A supplier processing juice for a retailer does not inherit the retailer’s exemption. Assess the actual operation and distribution route, including central kitchens, rather than assuming that a small business or farm is exempt. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120/subpart-A/section-120.3
Written hazard analysis and the conditional HACCP plan
Each covered processor must prepare a written hazard analysis under 120.7. Assess biological, chemical and physical hazards for the actual ingredients, process, packaging, storage and intended use. When one or more food hazards are reasonably likely to occur, 120.8 requires an implemented written HACCP plan specifying hazards, critical control points, limits, monitoring, corrective action, verification and records. Sanitation controls and their records also matter. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120/subpart-A/section-120.7
The plan must address each processing location and juice type. Group products or methods only when their hazards, critical control points, limits and required procedures are essentially identical; clearly identify and implement any unique features. A generic template or a supplier’s plan is not proof that a different site or blend is covered. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120/subpart-A/section-120.8
Five-log control: check the applicable pathway
Where 120.24(a) applies, controls must consistently achieve at least a 5-log reduction in the pertinent microorganism for at least the product’s shelf life under normal and moderate abuse conditions. Select the most resistant microorganism of public-health significance likely to occur in that juice. Validate the control for the actual product and process, including relevant pH, composition, equipment and operating limits; reassess changes under 120.11. Evidence must support the claimed conditions, but every recipe does not automatically require a newly commissioned laboratory study. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120/subpart-B/section-120.24
Section 120.24(a) exempts juice processors subject to Part 113 or Part 114 from that paragraph. It also exempts a single thermal step sufficient for shelf stability, or a thermal concentration process treating all ingredients, provided the written hazard analysis includes a copy of the thermal process. These are conditional exceptions to that paragraph, not exemptions from the remaining applicable juice HACCP duties. Assess other hazards and retain the required thermal-process evidence.
The five-log treatment is normally applied directly to juice. The limited citrus-surface option starts after culling and cleaning. Required treatment and final packaging occur within a single production facility operating under CGMP; processors claiming the specified thermal/Part 113/114 exception also process and finally package the exempt juice within one such facility. Do not combine unrelated reductions at different sites to claim compliance. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120/subpart-B/section-120.24
Thermal pasteurization, ultraviolet treatment and high-pressure processing are different methods. UV or HPP is not thermal pasteurization merely because it reduces pathogens. Confirm scientific support and any applicable treatment authorization separately. For UV, check the authorized use and operating conditions in 21 CFR 179.39; HACCP validation alone does not expand those conditions. No universal temperature/time recipe is supplied here. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-179/subpart-B/section-179.39
Who may perform the trained-individual functions?
Under 120.13, the responsible individual must have adequate training in juice HACCP principles equivalent to the FDA-recognized standardized curriculum, or qualifying job experience providing equivalent knowledge. The person need not be the processor’s employee. An FDA-recognized training institution is not universally mandatory. Assign the hazard analysis, plan development, specified verification/validation and record review to appropriately qualified people. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120/subpart-A/section-120.13
Retail juice and the warning-label rule
The relevant warning-label provision is 21 CFR 101.17(g); 120.12 concerns records. Packaged untreated juice sold by an exempt retailer can require the warning. Unpackaged juice served by the glass is outside that packaged-label requirement, but applicable state or local requirements still need review. The retail exemption does not depend on merely adding a label.
Section 101.17(g) addresses juice and juice-containing beverages lacking the specified pathogen-reduction processing. It specifies the warning’s wording, conspicuous placement, bold WARNING and box. The provision also has a conditional trade-document disclosure route for juice not distributed to retail consumers in the shipped form and destined solely for other manufacture, processing, labeling or repacking. Review that exception’s conditions. Neither a warning nor disclosure replaces a commercial processor’s Part 120 duties. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.17
Importer verification is an implemented procedure
Under 120.14, the importer either sources under a qualifying active FDA agreement meeting the regulation’s conditions or has and implements written verification procedures. Those procedures must contain product specifications designed to prevent injurious or insanitary food and affirmative steps demonstrating compliant processing. Do not assume a qualifying country agreement exists without checking its current scope. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120/subpart-A/section-120.14
Permitted affirmative steps include obtaining the lot-related HACCP and sanitation records described in the rule; an appropriate continuing or lot certificate; regular facility inspections; an English hazard analysis and HACCP plan together with the processor’s written guarantee; periodic testing together with an English written guarantee; or equivalent measures. A certificate can be one affirmative step, but it does not replace the overall written procedure and product specifications. Keep English records of what was done and the results under 120.12. Identify the actual Part 120 importer; the broker or registration US Agent is not automatically that person.
FSVP and preventive-controls exemptions are conditional
Under 1.501(b), the FSVP exemption for imported juice depends on a foreign supplier required to comply with, and complying with, Part 120; the importer must still meet 120.14. A separate conditional exemption addresses ingredients imported and used by a compliant juice processor. Assess any other foods independently. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-L/section-1.501
Section 117.5(c) exempts covered activities from Part 117 subparts C and G only when the facility is required to comply with, and complies with, Part 120 for those activities. It does not exempt every activity at a mixed facility or eliminate applicable CGMP duties. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-A/section-117.5
Retain evidence for the correct period
Under 120.12, retain required records for perishable or refrigerated juice for at least one year after the date the products were prepared. For frozen, preserved or shelf-stable products, retain them for two years or the product’s shelf life, whichever is longer, after the date the products were prepared. This includes the applicable sanitation, hazard-analysis, HACCP, monitoring, corrective-action and verification/validation evidence. Record actual observations and responsible signatures; required hazard analyses and plans must be signed and dated. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120/subpart-A/section-120.12
After six months following the monitoring date, specified sanitation and ongoing HACCP processing records may be stored offsite if available onsite within 24 hours of an official request. This is not blanket permission to move every required record. Electronically accessible onsite records must meet the applicable requirements, including Part 11. The seasonal-closure provision has its own immediate-return requirement. Importer records belong at the US importer’s place of business and must satisfy the applicable retention rules.
Juice-export evidence worksheet
This is an editorial preparation tool, not an FDA form or a validated HACCP plan. Create one row per product, site and process. Record the actual evidence and unresolved gaps; an empty field is not proof of compliance.
| Scope: | product and recipe version; beverage or non-beverage use; puree/concentrate status; packaging, storage and shelf life; each site’s processing or repacking activity; sales route; applicability decision and supporting provision. |
|---|---|
| Controls: | written hazard analysis and responsible qualified person; hazards reasonably likely to occur; applicable HACCP plan; pertinent microorganism; treatment or exact exception basis; scientific support and thermal-process record where required; single-facility/final-packaging assessment. |
| Evidence: | operating limits and monitoring; sanitation and corrective-action records; verification and validation/reassessment; importer identity, specifications and affirmative steps; English records; retention end date and retrieval location; reviewer, open gaps, owner and next action. |
Separate registration, shipment and 2026 renewal checks
Assess facility activities and exemptions before food-facility registration. Where required, registration, DUNS/UFI matching and a foreign facility’s US Agent are separate from HACCP. Prior Notice concerns applicable shipments. FCE/SID applies only when the actual product and process meet the acidified/low-acid canned-food filing requirements; it is not a routine juice-HACCP filing. FDA does not routinely require submission or approval of a juice HACCP plan. https://www.fda.gov/food/registration-food-facilities-and-other-submissions/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf
For a facility required to renew an existing food registration, use the October 1–December 31, 2026 window. Registration or an update before October 1 does not replace renewal. FDA food registration and renewal have no government filing fee; professional service charges are separate. Review applicability, existing records, authorized account access, facility details, US Agent confirmation, submission and completion evidence using https://fdabridge.com/blog/fda-food-facility-registration-renewal-2026
Keep account credentials and registration PINs private. Retain confirmation evidence in controlled records and share required registration information only through authorized channels. Never put credentials in a public worksheet or shipment document. The guide does not claim that registration, a certificate or a paid service guarantees shipment release.
FDABridge service scope and primary guidance
FDABridge provides food-facility registration and US Agent services within the agreed scope. Confirm deliverables and professional fees at https://fdabridge.com/food-facility-registration or send non-sensitive product/activity questions through https://fdabridge.com/contact . This article does not establish that laboratory studies, specialist process validation or HACCP-plan approval are included services.
FDA’s Juice HACCP Questions and Answers supplies practical scope and processing examples. Read it with the current regulations cited above; older guidance references do not replace current rules. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-juice-haccp-regulation