Guidance for Industry: Questions and Answers on Juice HACCP Regulation (2003) | Guideline Explorer

Description

For questions regarding this document, contact Amy Green at the Center for Food Safety and Applied Nutrition (CFSAN) at (Tel) 240-402-1642, (Fax) 301-436-2651, or e-mail amy.green@cfsan.fda.gov.

Scope & Applicability

Product Classes

4

Juice

Product category subject to FDA HACCP regulations.

Nectar

Diluted juice beverage containing fruit juice or puree

Alcoholic Beverage

Wines or cider where juice may be an ingredient

Juice Concentrate

Concentrated form of juice with specific exemption rules

Stakeholders

4

Processor

An establishment that performs processing steps on ACTPs.

Importer

Must comply with registration if meeting facility/responsible person definitions

Foreign Processor

Non-domestic entities subject to juice regulations

Dockets Management

Entity responsible for receiving written comments regarding the guidance

Regulatory Context

Attributes

1

Shelf-stable

LACF products

Identified Hazards

Hazards

3

Microbial growth

Delays may create conditions favorable to microbial growth

Pathogenic Microorganisms

Biological hazards that must be inactivated

Allergic Reactions

Potential hazard from ingredients like soy protein or sulfites

Related CFR Sections (7)

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 →
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 →
21CFR120.8§ 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 →
21CFR101.3§ 101.3 Identity labeling of food in packaged form.
(a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity.Read 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 →
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 →
21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

Related Warning Letters (10)

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.
2024-06-25
Juice/HACCP/Adulterated
G.N.R. Group Co., LTD.
2024-05-14
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Thuan Thien Producing Trading Limited Company
2024-04-02
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Barsotti Juice Company, Inc.
2024-03-05
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Sol-ti Inc.
2023-08-22
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Juicer Connections, Inc.
2023-05-02
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Liberty Fruit Co. Inc. DBA Carol’s Cuts
2023-03-28
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Bainbridge Beverage West, LLC
2022-12-27
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
2022-06-28