[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.368]
[Page 149]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 173_SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN
CONSUMPTION--Table of Contents
Subpart D_Specific Usage Additives
Sec. 173.368 Ozone.
Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment,
storage, and processing of foods, including meat and poultry (unless
such use is precluded by standards of identity in 9 CFR part 319), in
accordance with the following prescribed conditions:
(a) The additive is an unstable, colorless 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 additive is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter.
(c) The additive meets the specifications for ozone in the Food
Chemicals Codex, 4th ed. (1996), p. 277, which is incorporated by
reference. The Director of the Office of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20055, or may be examined at the
Office of Premarket Approval (HFS-200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, and at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
(d) The additive is used in contact with food, including meat and
poultry (unless such use is precluded by standards of identity in 9 CFR
part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase
in accordance with current industry standards of good manufacturing
practice.
(e) When used on raw agricultural commodities, the use is consistent
with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act
(the act) and not applied for use under section 201(q)(1)(B)(i)(I),
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.
[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002]
Additives that reference this regulation: |
