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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: 21CFR173.375]



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 173 -- SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

Subpart D--Specific Usage Additives

Sec. 173.375 Cetylpyridinium chloride.

Cetylpyridinium chloride (CAS Reg. No. 123-93-5) may be safely used in food in accordance with the following conditions:

(a) The additive meets the specifications of the United States Pharmacopeia (USP)/National Formulary (NF) described in USP 30/NF 25, May 1, 2007, pp. 1700-1701, 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. You may obtain copies from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or you may examine a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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/cfr/ibr-locations.html.

(b) The additive is used in food as an antimicrobial agent as defined in 170.3(o)(2) of this chapter to treat the surface of raw poultry carcasses. The solution in which the additive is used to treat raw poultry carcasses shall also contain propylene glycol (CAS Reg. No. 57-55-6) complying with 184.1666 of this chapter, at a concentration of 1.5 times that of cetylpyridinium chloride.

(c) The additive is used as follows:

(1) As a fine mist spray of an ambient temperature aqueous solution applied to raw poultry carcasses prior to immersion in a chiller, at a level not to exceed 0.3 gram cetylpyridinium chloride per pound of raw poultry carcass, provided that the additive is used in systems that collect and recycle solution that is not carried out of the system with the treated poultry carcasses; or

(2) As a liquid aqueous solution applied to raw poultry carcasses either prior to or after chilling at an amount not to exceed 5 gallons of solution per carcass, provided that the additive is used in systems that recapture at least 99 percent of the solution that is applied to the poultry carcasses. The concentration of cetylpyridinium chloride in the solution applied to the carcasses shall not exceed 0.8 percent by weight. When application of the additive is not followed by immersion in a chiller, the treatment will be followed by a potable water rinse of the carcass.

[72 FR 67576, Nov. 29, 2007, as amended at 76 FR 59248, Sept. 26, 2011; 81 FR 5593, Feb. 3, 2016]

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