Small Entity Compliance Guide: Juice HACCP | Guideline Explorer

Description

For questions regarding this document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1642).

Scope & Applicability

Product Classes

5

Fruit and vegetable juices

Products covered under 21 CFR Part 120.

Juice

Product category subject to FDA HACCP regulations.

Juice concentrates

Subject to regulations if intended for beverage use.

Shelf-Stable Juice

Juice that receives high thermal reduction and has different HACCP requirements

Juice Concentrate

Concentrated form of juice with specific exemption rules

Stakeholders

6

Small business

Entity type with specific compliance dates

Processor

An establishment that performs processing steps on ACTPs.

Importer

Must comply with registration if meeting facility/responsible person definitions

Very small business

Business averaging less than $1,000,000 in annual sales

Retail establishment

An operation providing juice directly to consumers, exempt from HACCP but subject to labeling.

Juice Processor

Entity engaged in manufacturing, processing, packing, or holding juice; Entity subject to 21 CFR part 120

Identified Hazards

Hazards

8

Microbiological hazards

Quantitative and predictive food microbiology; Topic of resources provided by FDA and USDA/ARS

Allergen

Production of novel substances not ordinarily produced

Physical hazards

Includes glass, metal, and stones

Patulin

common group of natural toxins

Glass fragments

Physical hazard leading to wine recall; Ingesting glass fragments can cause injury to the consumer; Physical hazard from glass containers

Microbial Pathogen

Biological hazard reasonably likely to occur in juice

Glass Shards

Physical hazard in juice products

Allergen Cross-Contamination

Chemical hazard concern when using shared equipment

Related CFR Sections (7)

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 →
21CFR120.3§ 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 →
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 →
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 →
21CFR120.12§ 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 →
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 →
21CFR120.14§ 120.14 Application of requirements to imported products.
This section sets forth specific requirements for imported juice.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
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Chaur Fong Inc. dba 888 Food Company
2022-09-13