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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2013]
[CITE: 21CFR184.1563]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

Subpart B--Listing of Specific Substances Affirmed as GRAS

Sec. 184.1563 Ozone.

(a) Ozone (O3, CAS Reg. No. 10028-15-6) is an unstable blue gas with a pungent, characteristic odor, which occurs freely in nature, It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen.

(b) The ingredient must be of a purity suitable for its intended use in accordance with 170.30(h)(1) of this chapter.

(c) In accordance with 184.1(b)(2), the ingredient is used to treat food only within the following specific limitations:

Category of foodMaximum treatment level in foodFunctional use
Bottled water that prior to ozonation meets the microbiological, physical, chemical, and radiological quality standards of 165.110 (b)(2) through (b)(5) of this chapterNot to exceed current good manufacturing practice. Current good manufacturing practice results in a maximum residual level at the time of bottling of 0.4 milligram of ozone per liter of bottled waterAntimicrobial agent, 170.3 (o)(2) of this chapter.

[47 FR 50210, Nov. 5, 1982, as amended at 60 FR 57130, Nov. 13, 1995]

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