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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 2018.

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, 2018]
[CITE: 21CFR178.1005]



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 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

Subpart B--Substances Utilized To Control the Growth of Microorganisms

Sec. 178.1005 Hydrogen peroxide solution.

Hydrogen peroxide solution identified in this section may be safely used to sterilize polymeric food-contact surfaces identified in paragraph (e)(1) of this section.

(a) Identity. For the purpose of this section, hydrogen peroxide solution is an aqueous solution containing not more than 35 percent hydrogen peroxide (CAS Reg. No. 7722-84-1) by weight, meeting the specifications prescribed in paragraph (c) of this section.

(b) Optional adjuvant substances. Hydrogen peroxide solution identified in paragraph (a) of this section may contain substances generally recognized as safe in or on food, substances generally recognized for their intended use in food packaging, substances used in accordance with a prior sanction or approval, and substances permitted by applicable regulations in parts 174 through 179 of this chapter.

(c) Specifications. Hydrogen peroxide solution shall meet the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 496-497, which is incorporated by reference. Hydrogen peroxide solution shall also meet the specifications for "Acidity," "Chloride," and "Other requirements" for Hydrogen Peroxide Concentrate in the United States Pharmacopeia 36th Revision (2013), pp. 3848-3849, 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, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined 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.

(d) Limitations. No use of hydrogen peroxide solution in the sterilization of food packaging material shall be considered to be in compliance if more than 0.5 part per million of hydrogen peroxide can be determined in distilled water packaged under production conditions (assay to be performed immediately after packaging).

(e) Conditions of use. (1) Hydrogen peroxide solution identified in and complying with the specifications in this section may be used by itself or in combination with other processes to treat food-contact surfaces to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in part 113 of this chapter. Food-contact surfaces include the following:

Substances Limitations
Ethylene-acrylic acid copolymersComplying with 177.1310 of this chapter.
Ethylene-carbon monoxide copolymersComplying with 177.1312 of this chapter.
Ethylene-methyl acrylate copolymer resinsComplying with 177.1340 of this chapter.
Ethylene-vinyl acetate copolymersComplying with 177.1350 of this chapter.
Ionomeric resinsComplying with 177.1330 of this chapter.
Isobutylene polymersComplying with 177.1420 (a)(1) and (a)(2) of this chapter.
Olefin polymersComplying with 177.1520 of this chapter.
Polycarbonate resinsComplying with 177.1580 of this chapter.
Polyethylene-terephthalate polymersComplying with 177.1630 of this chapter (excluding polymers described in 177.1630(c)) of this chapter.
Poly-l-butene resins and butene/ethylene copolymersComplying with 177.1570 of this chapter.
Polystryrene and rubber-modified polystyrene polymersComplying with 177.1640 of this chapter.
Vinylidene chloride/methyl acrylate copolymersComplying with 177.1990 of this chapter.

(2) The packaging materials identified in paragraph (e)(1) of this section may be used for packaging all commercially sterile foods except that the olefin polymers may be used in articles for packaging foods only of the types identified in 176.170(c) of this chapter, table 1, under Categories I, II, III, IV-B, V, and VI.

(3) Processed foods packaged in the materials identified in paragraph (e)(1) of this section shall conform with parts 108, 110, 113, and 114 of this chapter as applicable.

[46 FR 2342, Jan. 9, 1981, as amended at 49 FR 10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984; 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec. 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55 FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, 1992; 78 FR 71467, Nov. 29, 2013]

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