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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2019]
[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 food Maximum treatment level in food Functional 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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