[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: 21CFR178.1005]
[Page 356-358]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS--Table of Contents
Subpart B_Substances Utilized To Control the Growth of Microorganisms
Sec. 178.1005 Hydrogen peroxide solution.
Subpart A [Reserved]
Subpart B_Substances Utilized To Control the Growth of Microorganisms
Sec.
178.1005 Hydrogen peroxide solution.
178.1010 Sanitizing solutions.
Subpart C_Antioxidants and Stabilizers
178.2010 Antioxidants and/or stabilizers for polymers.
178.2550 4-Hydroxymethyl-2,6-di-tert-butylphenol.
178.2650 Organotin stabilizers in vinyl chloride plastics.
Subpart D_Certain Adjuvants and Production Aids
178.3010 Adjuvant substances used in the manufacture of foamed plastics.
178.3120 Animal glue.
178.3125 Anticorrosive agents.
178.3130 Antistatic and/or antifogging agents in food-packaging
materials.
178.3280 Castor oil, hydrogenated.
178.3290 Chromic chloride complexes.
178.3295 Clarifying agents for polymers.
178.3297 Colorants for polymers.
178.3300 Corrosion inhibitors used for steel or tinplate.
178.3400 Emulsifiers and/or surface-active agents.
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178.3450 Esters of stearic and palmitic acids.
178.3480 Fatty alcohols, synthetic.
178.3500 Glycerin, synthetic.
178.3505 Glyceryl tri-(12-acetoxystearate).
178.3520 Industrial starch-modified.
178.3530 Isoparaffinic petroleum hydrocarbons, synthetic.
178.3570 Lubricants with incidental food contact.
178.3600 Methyl glucoside-coconut oil ester.
178.3610 [alpha]-Methylstyrene-vinyltoluene resins, hydrogenated.
178.3620 Mineral oil.
178.3650 Odorless light petroleum hydrocarbons.
178.3690 Pentaerythritol adipate-stearate.
178.3700 Petrolatum.
178.3710 Petroleum wax.
178.3720 Petroleum wax, synthetic.
178.3725 Pigment dispersants.
178.3730 Piperonyl butoxide and pyrethrins as components of bags.
178.3740 Plasticizers in polymeric substances.
178.3750 Polyethylene glycol (mean molecular weight 200-9,500).
178.3760 Polyethylene glycol (400) monolaurate.
178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen
process) montan wax acids.
178.3780 Polyhydric alcohol esters of long chain monobasic acids.
178.3790 Polymer modifiers in semirigid and rigid vinyl chloride
plastics.
178.3800 Preservatives for wood.
178.3850 Reinforced wax.
178.3860 Release agents.
178.3870 Rosins and rosin derivatives.
178.3900 Sodium pentachlorophenate.
178.3910 Surface lubricants used in the manufacture of metallic
articles.
178.3930 Terpene resins.
178.3940 Tetraethylene glycol di-(2-ethyl-hexoate).
178.3950 Tetrahydrofuran.
Authority: 21 U.S.C. 321, 342, 348, 379e.
Source: 42 FR 14609, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 178 appear at 61 FR
14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27,
2001, 68 FR 15355, Mar. 31, 2003, and 70 FR 72074, Dec. 1, 2005.
Subpart A [Reserved]
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,'' 3d Ed. (1981), pp. 146-
147, which is incorporated by reference (Copies may be obtained from the
National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or may be examined 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.),
and the United States Pharmacopeia XX (1980), except that hydrogen
peroxide may exceed the concentration specified therein.
(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
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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 copolymers.......... Complying with Sec.
177.1310 of this chapter.
Ethylene-carbon monoxide copolymers....... Complying with Sec.
177.1312 of this chapter.
Ethylene-methyl acrylate copolymer resins. Complying with Sec.
177.1340 of this chapter.
Ethylene-vinyl acetate copolymers......... Complying with Sec.
177.1350 of this chapter.
Ionomeric resins.......................... Complying with Sec.
177.1330 of this chapter.
Isobutylene polymers...................... Complying with Sec.
177.1420 (a)(1) and (a)(2)
of this chapter.
Olefin polymers........................... Complying with Sec.
177.1520 of this chapter.
Polycarbonate resins...................... Complying with Sec.
177.1580 of this chapter.
Polyethylene-terephthalate polymers....... Complying with Sec.
177.1630 of this chapter
(excluding polymers
described in Sec.
177.1630(c)) of this
chapter.
Poly-l-butene resins and butene/ethylene Complying with Sec.
copolymers. 177.1570 of this chapter.
Polystryrene and rubber-modified Complying with Sec.
polystyrene polymers. 177.1640 of this chapter.
Vinylidene chloride/methyl acrylate Complying with Sec.
copolymers. 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 Sec. 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]
Additives that reference this regulation: |
