Description
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Scope & Applicability
Product Classes
10Product category subject to FDA HACCP regulations.
Example HACCP Plan for Pasteurized Refrigerated Apple Juice packed in plastic bottles.
Example Hazard Analysis for Not-from-Concentrate Pasteurized Orange Juice; The product type analyzed in the Hazard Analysis Summary Table.; third example is for a not-from-concentrate pasteurized orange juice.
Product subject to hazard analysis; Hazard Analysis Summary Table for Fresh Orange Juice; Example HACCP Plan for Fresh Orange Juice packed in plastic bottles.; Example HACCP Plan for Not-from-concentrate Pasteurized Orange Juice
The primary product category addressed by the guidance.; The specific food product category subject to the action level guidance
Juice transported in aseptic packaging
Juice with pH greater than 4.6, requiring consideration of Clostridium botulinum.
Juice processed to achieve shelf stability, exempt from 5-log reduction requirements.
Specific juice category with different 5-log reduction application rules.
Exempt from 5-log HACCP control measures but subject to other regulations.
Stakeholders
10Entities required to identify food safety hazards and develop plans
The production supervisor will review the equipment log prior to every juice production run
Person monitoring CCP 2 Screen
Person whose actions may cause a product to be deemed adulterated
Monitoring performed by the Culling inspector.
Monitoring performed by the Receiving manager.
The entity responsible for establishing controls at CCPs.
concentrate supplier is responsible under his/her HACCP program
different supplier or contract manufacturer
An establishment that performs processing steps on ACTPs.
Regulatory Context
Attributes
4Characteristic defining acidic juices.; Classification threshold for acidic juices.
process time and pressure for high pressure processing; monitoring of the parameters as critical limits be carried out; A supplier guarantee specifying that the shipment includes only apples harvested to exclude fallen fruit.; Parameters such as 200ppm chlorine or 160 deg. F; Validated cleaning process parameters: e.g., values for pre-rinse time & temperature
Intrinsic characteristic affecting the growth of L. monocytogenes; intrinsic characteristic used as a process control; parameter to monitor for control; Process control parameters such as pH; Used to define listeristatic formulations
Required state of citrus fruit for surface treatment
Identified Hazards
Hazards
10common group of natural toxins
CCP 3 Screen for the control of Metal inclusion.
excerpts included in this example are for the control of enteric pathogens, patulin, and metal fragments.
chemical hazard requiring supply-chain control; chemical hazard broadly applying to many foods in Fruits and Vegetables; Potential hazard identified for tea products.; Potential food-related chemical hazard
Undeclared allergen chemical hazard
Microbiological hazard causing adulteration; Sampling recommendations for detecting contamination
Hazards that may cause illness or injury to humans or animals; Hazards associated with animal food and facilities.; Foreign objects like metal or plastic fragments; sharp hazards, choking hazards, and conditions of animal food
internal apple rot causing patulin production
Includes radiological hazards in animal food; Includes radiological hazards to be evaluated.; Chemical substances including radiological hazards; Category of hazards including industrial contaminants
physical hazards in juice
Related CFR Sections (14)
- 21CFR120.13§ 120.13 Training.
(a) Only an individual who has met the requirements of paragraph (b) of this section shall be responsible for the following functions: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 →
- 21CFR120.11§ 120.11 Verification and validation.
(a) Verification. Each processor shall verify that the Hazard Analysis and Critical Control Point (HACCP) system is being implemented according to design.Read full regulation →
- 21CFR179.41§ 179.41 Pulsed light for the treatment of food.
Pulsed light may be safely used for treatment of foods under the following conditions:Read full regulation →
- 21CFR179.39§ 179.39 Ultraviolet radiation for the processing and treatment of food.
Ultraviolet radiation for the processing and treatment of food may be safely used under the following conditions:Read full regulation →
- 21CFR120.25§ 120.25 Process verification for certain processors.
Each juice processor that relies on treatments that do not come into direct contact with all parts of the juice to achieve the requirements of § 120.24 shall analyze the finished product for biotype I Escherichia coli as follows:Read full regulation →
- 21CFR178.1005§ 178.1005 Hydrogen peroxide solution.
Hydrogen peroxide solution identified in this section may be safely used to sterilize polymeric food-contact surfaces identified in paragraph (e)(1) of this section.Read full regulation →
- 21CFR120.6§ 120.6 Sanitation standard operating procedures.
(a) Sanitation controls. Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing. The SSOP shall address:Read full regulation →
- 21CFR120.7§ 120.7 Hazard analysis.
(a) 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 hazaRead full regulation →
- 21CFR120.12§ 120.12 Records.
(a) Required records. Each processor shall maintain the following records documenting the processor's Hazard Analysis and Critical Control Point (HACCP) system:Read full regulation →
- 21CFR101.17§ 101.17 Food labeling warning, notice, and safe handling statements.
(a) Self-pressurized containers.Read full regulation →
- 21CFR120.8§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
(a) HACCP plan. 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 trRead full regulation →
- 21CFR120.3§ 120.3 Definitions.
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act, § 101.9(j)(18)(vi) of this chapter , and parts 110 and 117 of this chapter are applicable to such terms when used in this part, except that the definitions and terms in parts 110 and 117 do not govern such terms wheRead full regulation →
- 21CFR101.30§ 101.30 Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.
(a) This section applies to any food that purports to be a beverage that contains any fruit or vegetable juice (i.e., the product's advertising, label, or labeling bears the name of, or variation on the name of, or makes any other direct or indirect representation with respect to, any fruit or vegetRead full regulation →
Related Warning Letters (10)
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-06-24
Food Labeling/Misbranded
Revolution Foods, PBC
- 2025-06-03
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
One Roof LLC
- 2025-06-03
Low Acid Canned Food Regulation/Adulterated
United King Foods Private Limited
- 2025-05-21
Low Acid Canned Food Regulation/Adulterated
Baldwin Richardson Foods Pennsauken, LLC
- 2025-05-20
Low Acid Canned Food Regulation/Adulterated
Chongqing Tianrun Food Development Co., Ltd
- 2025-05-20
Low Acid Canned Food Regulation/Adulterated
Dalai Biotech Company Ltd
- 2025-01-21
Acidified Foods/Emergency Permit Control/Adulterated
Miyajima Shoyu Co., Ltd.
- 2024-12-03
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Mena Food Group, LLC
- 2024-11-26
Acidified Foods/Emergency Permit Control/Adulterated
Tova Industries, LLC
See Also (8)
- Guidance for Industry: Standardized Training Curriculum for Application of HACCP Principles to Juice Processing (Status: Final)
- Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (Status: Final)
- Guidance for Industry: Exemptions from the Warning Label Requirement for Juice (Status: Final)
- Guidance for Industry: Bulk Transport of Juice Concentrates and Certain Shelf-Stable Juices (Status: Final)
- Small Entity Compliance Guide: Juice HACCP (Status: Final)
- Guidance for Industry: Sanitary Transportation of Food (Status: Final)
- Guidance for Industry: Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes (Status: Final)
- Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration (Status: Final)