[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 176_INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS--Table
Subpart B_Substances for Use Only as Components of Paper and Paperboard
Sec. 176.210 Defoaming agents used in the manufacture of paper and
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
(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
(1) Fatty triglycerides, and the fatty acids, alcohols, and dimers
(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).
Butoxy-polyoxypropylene, molecular weight 1,000-2,500 (esters).
Butylene glycol (esters).
Calcium hydroxide (soaps).
Diethylene glycol (esters).
Ethylene glycol (esters).
Ethylene oxide (esters and ethers).
Glycerin (mono- and diglycerides).
Hydrogen (hydrogenated compounds).
Magnesium hydroxide (soaps).
Oxygen (air-blown oils).
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).
Propylene glycol (esters).
Propylene oxide (esters).
Sodium hydroxide (soaps).
Sulfuric acid (sulfated and sulfonated compounds).
Triethanolamine (amides and soaps).
Triisopropanolamine (amides and soaps).
Zinc hydroxide (soaps).
Alcohols and ketone alcohols mixture (still-bottom product from
C12-C18 alcohol manufacturing process).
Butoxy polyethylene polypropylene glycol molecular weight 900-4,200.
Butoxy-polyoxypropylene molecular weight 1,000-2,500.
Calcium lignin sulfonate.
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
2,6-Dimethyl heptanol-4 (nonyl alcohol).
Dodecylbenzene sulfonic acids.
Ethylenediamine tetraacetic acid tetra sodium salt.
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).
Hexylene glycol (2-methyl-2-4-pentanediol).
Isopropylamine salt of dodecylbenzene sulfonic acid.
Methyl taurine-oleic acid condensate, molecular weight 486.
hydroxypoly (oxyethylene)] having 6-7.5 moles of ethylene oxide per
Mono-, di-, and triisopropanolamine.
Mono- and diisopropanolamine stearate.
Monobutyl ether of ethylene glycol.
Odorless light petroleum hydrocarbons.
Polybutene, hydrogenated; complying with the identity prescribed under
Sec. 178.3740(b) of this chapter.
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
Polyoxyethylene (4 mols) decyl phosphate.
Polyoxyethylene (4 mols) di(2-ethyl hex ano ate).
Polyoxyethylene (15 mols) ester of rosin.
Polyoxyethylene (3-15 mols) tridecyl alcohol.
Polyoxypropylene, molecular weight 200-2,000.
Polyoxypropylene-polyoxethylene condensate, minimum molecular weight
Polyoxypropylene-ethylene oxide condensate of ethylene diamine,
molecular weight 1,700-3,800.
Polyvinyl pyrrolidone, molecular weight 40,000.
Potassium distearyl phosphate.
Rosins and rosin derivatives identified in Sec. 175.105(c)(5) of this
Siloxanes and silicones, dimethyl, meth yl hy drogen, reaction products
with polyethylene-polypropylene glycol mono allyl ether (CAS Reg. No.
Sodium alkyl (C9-C15) benzene-sulfonate.
Sodium dioctyl sulfosuccinate.
Sodium distearyl phosphate.
Sodium lauryl sulfate.
Sodium lignin sulfonate.
Sodium naphthalenesulfonic acid (3 mols) condensed with formaldehyde (2
Sodium petroleum sulfonate, molecular weight 440-450.
[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.
Triethylene glycol di(2-ethyl hexanoate).
Wax, petroleum, Type I and Type II.
Wax, petroleum (oxidized).
[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]
Additives that reference this regulation:
- ALKANOLAMIDE OF COCONUT OIL FATTY ACIDS AND DIETHANOLAMINE
- ALPHA-(P-(1,1,3,3-TETRAMETHYLBUTYL)PHENYL)-OMEGA-HYDROXYPOLY(OXYETHYLENE)(GREATER THAN 1 MOL)
- ALUMINUM HYDROXIDE
- AMYL ALCOHOL
- BUTYL ALCOHOL
- BUTYLATED HYDROXYANISOLE
- BUTYLATED HYDROXYTOLUENE
- CALCIUM HYDROXIDE
- CALCIUM LIGNOSULFONATE
- CASTOR OIL (RICINUS COMMUNIS L.)
- COCONUT OIL
- DIETHANOLAMIDE CONDENSATE FROM SOYBEAN OIL FATTY ACIDS (C16-C18)
- DIOCTYL SODIUM SULFOSUCCINATE
- EDTA, TETRASODIUM
- ETHYLENE GLYCOL MONOBUTYL ETHER
- ETHYLENE OXIDE
- ETHYLENE OXIDE/PROPYLENE OXIDE COPOLYMER
- ETHYLENE OXIDE/PROPYLENE OXIDE COPOLYMER
- FISH OIL (HYDROGENATED)
- ISOBUTYL ALCOHOL
- ISOPROPYL ALCOHOL
- LARD OIL
- LIGNIN SODIUM SULFONATE
- MAGNESIUM HYDROXIDE
- METHYL ALCOHOL
- METHYL ISOBUTYL KETONE
- MUSTARD OIL
- MYRISTYL ALCOHOL
- PEANUT OIL
- PETROLEUM HYDROCARBONS, ODORLESS, LIGHT
- POLYETHYLENE (M W 2,000-21,000)
- POLYETHYLENE, OXIDIZED
- POTASSIUM HYDROXIDE
- PROPYL ALCOHOL
- PROPYLENE GLYCOL
- PROPYLENE OXIDE
- RAPESEED OIL, HYDROGENATED
- SILICON DIOXIDE
- SODIUM HYDROXIDE
- SODIUM LAURYL SULFATE
- SOYBEAN OIL, HYDROGENATED
- SPERM OIL
- SPERM OIL, HYDROGENATED
- STEARYL ALCOHOL
- SULFURIC ACID
- TALLOW ALCOHOL, HYDROGENATED
- TALLOW, BEEF
- TALLOW, HYDROGENATED
- TETRAHYDROFURFURYL ALCOHOL