Juice HACCP - Food Manufacturers, Wholesalers, and Warehouses

U.S. Food and Drug Administration - Hazard Analysis and Critical Control Point

Juice is the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.   The U.S. Food and Drug Administration (FDA) requires juice processors to develop and implement Hazard Analysis and Critical Control Point (HACCP) systems for their processing operations.  Retail producers of juices are not covered by the regulation and would not be required to establish a HACCP system regardless of whether they pasteurize their products.  However, retail producers must comply with FDA's food labeling regulation in 21 CFR 101.17(g) that requires a warning statement on packaged fruit and vegetable juice products that have not been processed to prevent, reduce, or eliminate pathogenic microorganisms that may be present, and with any applicable state regulations [21 CFR 101. 17 (g)(2)(ii)]. 

Each processor shall develop, or have developed for it, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice processed by that processor and to identify control measures that the processor can apply to control those hazards.  Food hazard is any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.  Each processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food hazards that are reasonably likely to occur during processing, as described in § 120.7. The HACCP plan shall be developed by an individual or individuals who have been trained in accordance with § 120.13 and shall be subject to the recordkeeping requirements of § 120.12.

Additional Resources
• Juice HACCP: https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp
• 21 CFR Part 120 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=120
• Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first
• Guidance for Industry: Questions and Answers on Juice HACCP Regulation (2001):  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-juice-haccp-regulation
• Guidance for Industry: Questions and Answers on Juice HACCP Regulation (2003): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-juice-haccp-regulation-2003#a
• Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-haccp-and-fda-food-safety-modernization-act

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Last updated March 4, 2021