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Which regime are you in? A check

Updated

On this page5

Run this before printing a label, before the first wholesale order, and after any reformulation.

Two questions, answered separately

They are independent. A product can be inside both, one, or neither.

Question one: is there juice in it?

1. Does the product contain fruit or vegetable juice, as juice, concentrate or puree, in any proportion?

If no, the juice HACCP regime does not apply. Stop here for this question.

If yes:

2. Has it been processed to achieve a 5-log reduction in the pertinent pathogen, by a validated process?

3. Do you sell or distribute it to any other business, a shop, a café, a restaurant, a distributor?

Untreated and direct-to-consumer only: you are within the retail exemption from HACCP, and you must carry the warning statement.

Sold to any business: you are a processor and HACCP applies to what you make, including what you still sell directly.

Treated to 5-log: no warning statement, and HACCP if you are a processor.

Question two: does it ferment?

4. Is there a live culture in the finished product?

5. Is there fermentable sugar left in the bottle?

6. Have you measured alcohol on a sample held at the warmest realistic temperature for the FULL shelf life, at a laboratory?

If 4 and 5 are yes and 6 is no, you do not know which regime you are in. That is the answer, and it is the common one.

7. Was that result 0.5 percent ABV or more?

If yes, the product is an alcohol beverage: TTB-qualified premises, brewer qualification, a filed formula, excise tax and the ABLA health warning.

Re-run it when anything changes

A new ingredient, a new supplier, a new size, a first wholesale order, a change of culture, a change of process temperature, or a longer stated shelf life.

And every summer, because the warmest realistic temperature is not the same number in January.

References

21 CFR Part 120, Hazard Analysis and Critical Control Point (HACCP) Systems for juice. Covered processors must achieve a 5-log reduction in the pertinent pathogen. ecfr.gov
US Food and Drug Administration. Exemptions from the Warning Label Requirement for Juice. A retail establishment selling juice directly to consumers and not distributing to other businesses is exempt from the HACCP rule, and untreated juice must still carry the warning statement. fda.gov
Alcohol and Tobacco Tax and Trade Bureau. Kombucha. Kombucha at 0.5 percent alcohol by volume or more, at any time during production, when bottled, or at any time after bottling as a result of continued fermentation, is an alcohol beverage subject to TTB regulation. ttb.gov
Alcohol and Tobacco Tax and Trade Bureau. Requirements for Kombucha Classified as Beer. Fermented beverages at or above 0.5 percent ABV are classified as beer for tax purposes; a brewer must qualify under 27 CFR part 25 and file a formula before production. ttb.gov
Written from the federal regulation and agency guidance named on each page, not from a laboratory. Whether a particular product meets a pathogen reduction requirement, and what its alcohol content actually is, are measurements about your product, and this is not those measurements.