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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 2015.

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, 2015]
[CITE: 21CFR176.210]



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 176 -- INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

Subpart B--Substances for Use Only as Components of Paper and Paperboard

Sec. 176.210 Defoaming agents used in the manufacture of paper and paperboard.

Defoaming agents may be safely used in the manufacture of paper and paperboard intended for use in packaging, transporting, or holding food in accordance with the following prescribed conditions:

(a) The defoaming agents are prepared from one or more of the substances named in paragraph (d) of this section, subject to any prescribed limitations.

(b) The defoaming agents are used to prevent or control the formation of foam during the manufacture of paper and paperboard prior to and during the sheet-forming process.

(c) The quantity of defoaming agent or agents added during the manufacturing process shall not exceed the amount necessary to accomplish the intended technical effect.

(d) Substances permitted to be used in the formulation of defoaming agents include substances subject to prior sanctions or approval for such use and employed subject to the conditions of such sanctions or approvals, substances generally recognized as safe for use in food, substances generally recognized as safe for use in paper and paperboard, and substances listed in this paragraph, subject to the limitations, if any, prescribed.

(1) Fatty triglycerides, and the fatty acids, alcohols, and dimers derived therefrom:

Beef tallow.

Castor oil.

Coconut oil.

Corn oil.

Cottonseed oil.

Fish oil.

Lard oil.

Linseed oil.

Mustardseed oil.

Palm oil.

Peanut oil.

Rapeseed oil.

Ricebran oil.

Soybean oil.

Sperm oil.

Tall oil.

(2) Fatty triglycerides, and marine oils, and the fatty acids and alcohols derived therefrom (paragraph (d)(1) of this section) reacted with one or more of the following, with or without dehydration, to form chemicals of the category indicated in parentheses:

Aluminum hydroxide (soaps).

Ammonia (amides).

Butanol (esters).

Butoxy-polyoxypropylene, molecular weight 1,000-2,500 (esters).

Butylene glycol (esters).

Calcium hydroxide (soaps).

Diethanolamine (amides).

Diethylene glycol (esters).

Ethylene glycol (esters).

Ethylene oxide (esters and ethers).

Glycerin (mono- and diglycerides).

Hydrogen (hydrogenated compounds).

Hydrogen (amines).

Isobutanol (esters).

Isopropanol (esters).

Magnesium hydroxide (soaps).

Methanol (esters).

Morpholine (soaps).

Oxygen (air-blown oils).

Pentaerythritol (esters).

Polyoxyethylene, molecular weights 200, 300, 400, 600, 700, 1,000, 1,540, 1,580, 1,760, 4,600 (esters).

Polyoxypropylene, molecular weight 200-2,000 (esters).

Potassium hydroxide (soaps).

Propanol (esters).

Propylene glycol (esters).

Propylene oxide (esters).

Sodium hydroxide (soaps).

Sorbitol (esters).

Sulfuric acid (sulfated and sulfonated compounds).

Triethanolamine (amides and soaps).

Triisopropanolamine (amides and soaps).

Trimethylolethane (esters).

Zinc hydroxide (soaps).

(3) Miscellaneous:

Alcohols and ketone alcohols mixture (still-bottom product from C12-C18 alcohol manufacturing process).

Amyl alcohol.

Butoxy polyethylene polypropylene glycol molecular weight 900-4,200.

Butoxy-polyoxypropylene molecular weight 1,000-2,500.

Butylated hydroxyanisole.

Butylated hydroxytoluene.

Calcium lignin sulfonate.

Capryl alcohol.

p- Chlorometacresol.

Cyclohexanol.

Diacetyltartaric acid ester of tallow mono-glyceride.

1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691-65-7), for use as a preservative at a level not to exceed 0.05 weight-percent of the defoaming agent.

Diethanolamine.

Diethylene triamine.

Di-(2-ethylhexyl) phthalate.

2,6-Dimethyl heptanol-4 (nonyl alcohol).

Dimethylpolysiloxane.

Di-tert- butyl hydroquinone.

Dodecylbenzene sulfonic acids.

Ethanol.

2-Ethylhexanol.

Ethylenediamine tetraacetic acid tetrasodium salt.

Formaldehyde.

Heavy oxo-fraction (a still-bottom product of iso-octyl alcohol manufacture, of approximate composition: Octyl alcohol 5 percent nonyl alcohol 10 percent, decyl and higher alcohols 35 percent, esters 45 percent, and soaps 5 percent).

2-Heptadecenyl-4-methyl-4-hydroxymethyl-2-oxazoline.

Hexylene glycol (2-methyl-2-4-pentanediol).

12-Hydroxystearic acid.

Isobutanol.

Isopropanol.

Isopropylamine salt of dodecylbenzene sulfonic acid.

Kerosine.

lanolin .

Methanol.

Methyl 12-hydroxystearate.

Methyl taurine-oleic acid condensate, molecular weight 486.

a,a' -[Methylenebis[4-(1,1,3,3-tetramethylbu-tyl)-o -phenylene>bis [omega -hydroxypoly (oxyethylene)] having 6-7.5 moles of ethylene oxide per hydroxyl group.

Mineral oil.

Mono-, di-, and triisopropanolamine.

Mono- and diisopropanolamine stearate.

Monobutyl ether of ethylene glycol.

Monoethanolamine.

Morpholine.

Myristyl alcohol.

Naphtha.

[beta]-Naphthol.

Nonylphenol.

Odorless light petroleum hydrocarbons.

Oleyl alcohol.

Petrolatum.

o- Phenylphenol.

Pine oil.

Polybutene, hydrogenated; complying with the identity prescribed under 178.3740(b) of this chapter.

Polyethylene.

Polyethylene, oxidized (air-blown).

Polymer derived from N -vinyl pyrrolidone and copolymers derived from the mixed alkyl (C12-C15, C16, C18, C20, and C22) methacrylate esters, butyl methacrylate (CAS Reg. No. 97-88-1), isobutyl methacrylate (CAS Reg. No. 97-86-9) and methyl methacrylate (CAS Reg. No. 80-62-6); the combined polymer contains no more than 5 weight percent of polymer units derived from N -vinyl pyrrolidone and is present at a level not to exceed 7 parts per million by weight of the finished dry paper and paperboard fibers.

Polyoxyethylene (4 mols) decyl phosphate.

Polyoxyethylene (4 mols) di(2-ethyl hexanoate).

Polyoxyethylene (15 mols) ester of rosin.

Polyoxyethylene (3-15 mols) tridecyl alcohol.

Polyoxypropylene, molecular weight 200-2,000.

Polyoxypropylene-polyoxethylene condensate, minimum molecular weight 950.

Polyoxypropylene-ethylene oxide condensate of ethylene diamine, molecular weight 1,700-3,800.

Polyvinyl pyrrolidone, molecular weight 40,000.

Potassium distearyl phosphate.

Potassium pentachlorophenate.

Potassium trichlorophenate.

Rosins and rosin derivatives identified in 175.105(c)(5) of this chapter.

Silica.

Siloxanes and silicones, dimethyl, methylhydrogen, reaction products with polyethylene-polypropylene glycol monoallyl ether (CAS Reg. No. 71965-38-3).

Sodium alkyl (C9-C15) benzene-sulfonate.

Sodium dioctyl sulfosuccinate.

Sodium distearyl phosphate.

Sodium lauryl sulfate.

Sodium lignin sulfonate.

Sodium 2-mercaptobenzothiazole.

Sodium naphthalenesulfonic acid (3 mols) condensed with formaldehyde (2 mols).

Sodium orthophenylphenate.

Sodium pentachlorophenate.

Sodium petroleum sulfonate, molecular weight 440-450.

Sodium trichlorophenate.

Stearyl alcohol.

[alpha]-[p- (1,1,3,3-Tetramethylbutyl) phenyl-, p- nonylphenyl-, or p- dodecylphenyl]-omega- hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p- alkylphenol (alkyl group is 1,1,3,3-tetramethylbutyl, a propylene trimer isomer, or a propylene tetramer isomer) with an average of 1.5-15 moles of ethylene oxide.

Tetrahydrofurfuryl alcohol.

Tributoxyethyl phosphate.

Tributyl phosphate.

Tridecyl alcohol.

Triethanolamine.

Triethylene glycol di(2-ethyl hexanoate).

Tri-(2-ethylhexyl) phosphate.

Tristearyl phosphate.

Wax, petroleum, Type I and Type II.

Wax, petroleum (oxidized).

Wax (montan).

[42 FR 14554, Mar. 15, 1977, as amended at 47 FR 17986, Apr. 27, 1982; 47 FR 46495, Oct. 19, 1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897, June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR 14246, Apr. 1, 1996]

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