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The Juice HACCP regulation applies to processors, repackers, or importers of juice sold at wholesale (sold or distributed to other business entities) including: 

• 100% juice or juice concentrates (including persons using pasteurized or otherwise treated juice ingredients)
• Fruit or vegetable purees
• Non-Juice Beverage with a juice ingredient (e.g, lemonade using fresh squeezed lemon juice). NOTE: For beverages containing less than 100% juice, only the fresh juice ingredient is subject to HACCP principles
• Juice produced and sold within the same state as well as juice sold in interstate commerce
• Juice importers

The Juice HACCP regulation does NOT apply to: 

• Juice produced at a retail establishment and sold exclusively and directly to consumers (e.g., stores, roadside stands, farmers markets, juice bars, etc.)
• Juice beverages (<100% juice) using only treated (i.e., pasteurized) juice ingredients which were produced under juice HACCP principles (e.g., juice beverage produced from a pasteurized concentrate or lemonade produced from pasteurized lemon juice)
• Fruit or vegetable by-products (e.g., citrus oil)
• Juice ingredient used in the production of a non-beverage food (e.g., fruit flavored candy)
• Beverages using whole fruits or vegetables without juice extraction (e.g., smoothies)
• Warehousing or storage of the juice only (without processing)
• Harvesting, picking, or transporting raw agricultural ingredients of juice products without otherwise engaging in processing
• Juice used solely as a starting material for a fermented alcoholic product (Ex. wine or hard cider) in which the juice becomes an alcoholic beverage and is no longer recognizable as juice at the time processing is complete

Juice is the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one of more fruits or vegetables, or any concentrates of such liquid or puree.

Juice concentrate means the aqueous liquid expressed or extracted from one or more fruits or vegetables and reduced in weight and volume through the removal of water from the juice.

• Processing - includes grinding, squeezing, extracting, expressing, pureeing or other actions to obtain the juice.
• Processor – means any person engaged in commercial, custom, or institutional processing of juice products, either domestic or foreign, including any person engaged in the processing of juice products that are intended for use in market or consumer tests.
• Retail Establishment – means an operation that provides juice directly to consumers and does not sell or distribute juice to other businesses. The term "provides" includes storing, preparing, packaging, serving, and selling juice.

Coconut is considered a fruit and any liquid extracted from coconut (i.e., water or milk from the meat) is considered a juice and is therefore subject to regulation. 

• The regulation applies to any unfermented juice that is added to an alcoholic beverage (e.g., wine or cider) as an ingredient to adjust flavor or sweetness and retains and expresses its organoleptic (e.g., color, taste) and nutritional characteristics in the finished beverage (§120.1(a)). This would also apply to any non-alcoholic beverages (i.e., kombucha) for which the juice does not undergo full fermentation.
• The juice treatment (5-log pathogen reduction) must be applied directly to the juice, not to the fruit or vegetable (except for citrus juices).
• Juice subject to the juice HACCP regulation is NOT allowed to be sold without a 5-log pathogen reduction.
• Juice sold at retail (therefore exempt from the juice HACCP regulation) is allowed to be sold without a 5-log reduction but MUST be properly labeled with a statement conspicuously posted on the principal display panel and must read:

  • WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.

If a firm sells or distributes any amount of juice to other businesses, the Retail Food Establishment exemption no longer applies, and they would be considered a juice processor subject to Juice HACCP.  All their juice products must be produced accordingly under Juice HACCP principles. This includes processing the juice to produce a minimum 5-log reduction in the pertinent microorganism.

Below are 3 examples to help you determine if your product is subject to the FDA Juice HACCP regulation (21 CFR 120).  If you still have questions, then please reach out to the MDA Licensing Liaison to further assist you in this determination.

Example 1: Company A processes juice in a central kitchen and sells the juice to consumers from its own retail outlets. Is Company A's central kitchen considered a retail establishment? Are Company A's retail outlets considered retail establishments?

• Answer: Company A's central kitchen is not a retail establishment that is exempt from the regulation because it does not sell juice directly to consumers at that location. However, Company A's retail outlets are retail establishments under part 120, if they sell juice directly to consumers and do not sell juice to other business entities (i.e., retail outlets owned by another company).

Example 2: Company B processes juice in a central kitchen that sells juice directly to consumers from its central kitchen as well as supplying its retail outlets. Is the central kitchen a retail establishment? Are Company B's outlets retail establishments?

• Answer: Company B's central kitchen is a retail establishment under part 120, because it (1) sells juice directly to consumers and (2) does not sell juice to other business entities (i.e., it provides juice only to the retail establishments it owns). If the retail outlets owned by Company B sell juice directly to consumers, but not to other business entities, they are also retail establishments under part 120. FDA encourages central kitchens that are retail establishments under the rule to establish a HACCP system in the processing of juice.

Example 3: If Company C processes juice in a central kitchen that sells juice directly to consumers from its central kitchen and from its retail outlets, but also sells juice to other business entities, is the central kitchen a retail establishment?

• Answer: Even though Company C sells juice directly to consumers at its central kitchen, the central kitchen is not a retail establishment for purposes of part 120 because it sells juice to business entities that it does not own.