Description
This guidance represents the agency's current thinking on reducing microbial food safety hazards in juice. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. This guidance document supercedes "Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance Guide," September 18, 1998.
Scope & Applicability
Product Classes
1Product category subject to FDA HACCP regulations.
Stakeholders
3processors subject to HACCP rule by January 20, 2004
processors subject to HACCP rule by January 21, 2003; Entities not subject to the juice HACCP rule until January 21, 2003.
An operation providing juice directly to consumers, exempt from HACCP but subject to labeling.
Regulatory Context
Attributes
2The specific performance standard for pathogen reduction (100,000-fold).
intended storage conditions throughout the proposed shelf-life
Identified Hazards
Hazards
2Microbiological hazard causing adulteration; Sampling recommendations for detecting contamination
Biological hazards the cleaning protocol should eliminate
Related CFR Sections (3)
- 21CFR101.17§ 101.17 Food labeling warning, notice, and safe handling statements.
(a) Self-pressurized containers.Read full regulation →
- 21CFR120.24§ 120.24 Process controls.
(a) In order to meet the requirements of subpart A of this part , processors of juice products shall include in their Hazard Analysis and Critical Control Point (HACCP) plans control measures that will consistently produce, at a minimum, a 5 log ( i.e., 10 5 ) reduction, for a period at least as lonRead full regulation →
- 21CFR120.1§ 120.1 Applicability.
(a) Any juice sold as such or used as an ingredient in beverages shall be processed in accordance with the requirements of this part. Juice means 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 anyRead full regulation →
Related Warning Letters (10)
- 2024-06-25
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Tamara Fruit CJSC
- 2024-06-25
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Raya Green Coconut Co.
- 2024-05-14
Juice/HACCP/Adulterated
G.N.R. Group Co., LTD.
- 2024-04-02
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Thuan Thien Producing Trading Limited Company
- 2024-03-05
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Barsotti Juice Company, Inc.
- 2023-08-22
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Sol-ti Inc.
- 2023-05-02
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Juicer Connections, Inc.
- 2023-03-28
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Liberty Fruit Co. Inc. DBA Carol’s Cuts
- 2022-12-27
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Bainbridge Beverage West, LLC
- 2022-05-31
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Russ Davis Wholesale Inc
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation (Status: Final)
- Small Entity Compliance Guide: Juice HACCP (Status: Final)
- Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (Status: Draft)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact (Status: Draft)
- FDA Oversight of Food Covered by Systems Recognition Arrangements (Status: Final)
- Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (Status: Final)