Juice HACCP (21 CFR Part 120)
21 CFR Part 120 requires that any juice that is sold as such or is used as an ingredient in beverages is processed employing a Hazard Analysis and Critical Control Point (HACCP) system. Juice is defined as the aqueous liquid 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. This is required for all juices regardless of whether the juice or juice ingredients have been shipped in interstate commerce. One exception to this rule is producers of raw agricultural ingredients of juice (Juice HACCP). Raw producers are not required to have a HACCP plan but the processors of the raw ingredients are required to have a HACCP plan for their final product. The regulations in this part apply to all businesses, small and large, since January 2004.
The process and steps for developing a HACCP plan for juice processors are described within this rule, including SSOPs, corrective actions, and required training. If a processor fails to have and to correctly implement a HACCP system that complies with 21 CFR Part 120 the juice is considered an adulterated product in accordance with the Federal Food, Drug, and Cosmetic Act.FDA Guidance
- Guidance for Industry:Juice HACCP and the FDA Food Safety Modernization Act August 2017
- Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices June 2007
- Guidance for Industry: Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and Cider September 22, 2005
- Guidance for Industry: Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes October 2004
- Guidance for Industry: Juice HACCP Hazards and Controls Guidance - First Edition March 3, 2004
- Juice Imports: Affirmative Steps - Lists of Foreign Processors Approved by their Governments January 22, 2004
- Guidance for Industry: Questions & Answers for the Juice HACCP Regulation September 4, 2003
- Guidance for Industry: Bulk Transport of Juice Concentrates and Certain Shelf Stable Juices April 24, 2003
- Guidance for Industry: Juice HACCP Small Entity Compliance Guide April 4, 2003
- Adulteration with Patulin in Apple Juice and Apple Juice Concentrates
