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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 2016.

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, 2016]
[CITE: 21CFR176.200]



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. 176.200 Defoaming agents used in coatings.

The defoaming agents described in this section may be safely used as components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section.

(a) The defoaming agents are prepared as mixtures of substances described in paragraph (d) of this section.

(b) The quantity of any substance employed in the formulation of defoaming agents does not exceed the amount reasonably required to accomplish the intended physical or technical effect in the defoaming agents or any limitation further provided.

(c) Any substance employed in the production of defoaming agents and which is the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter conforms with any specification in such regulation.

(d) Substances employed in the formulation of defoaming agents include:

(1) Substances generally recognized as safe in food.

(2) Substances subject to prior sanction or approval for use in defoaming agents and used in accordance with such sanction or approval.

(3) Substances identified in this paragraph (d)(3) and subject to such limitations as are provided:

List of substances Limitations
n-Butyl alcohol
tert-Butyl alcohol
Butyl stearate
Castor oil, sulfated, ammonium, potassium, or sodium salt
Cetyl alcohol
Cyclohexane
Cyclohexanol
Diethylene glycol monolaurate
Diethylene glycol monostearate
Dimers and trimers of unsaturated C18 fatty acids derived from:For use only at levels not to exceed 0.1% by weight of total coating solids.
Animal and vegetable fats and oils.
Tall oil.
Dimethylpolysiloxane
[alpha]-(Dinonylphenyl)-[omega]-hydroxy-poly(oxy-1,2-ethanediyl), containing 7 to 24 moles of ethylene oxide per mole of dinonylphenol (CAS Reg. No. 9014-93-1)For use only in defoaming agents for the production of styrene-butadiene coatings at a level not to exceed 0.05 percent by weight of the finished coating.
Dipropylene glycol
Ethyl alcohol
Fats and oils derived from animal, marine, or vegetable sources:
Fatty acids derived from animal, marine, or vegetable fats and oils, and salts of such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Zinc.
FormaldehydeFor use as preservative of defoamer only.
Glyceryl mono-12-hydroxystearate
Glyceryl monostearate
Hexane
Hexylene glycol (2-methyl-2,4-pentanediol)
Isobutyl alcohol
Isopropyl alcohol
Kerosene
Lecithin hydroxylated
Methyl alcohol
Methylcellulose
Methyl esters of fatty acids derived from animal, marine, or vegetable fats and oils
Methyl oleate
Methyl palmitate
Mineral oil
Mustardseed oil, sulfated, ammonium, potassium, or sodium salt
Myristyl alcohol
Naphtha
[beta]-NaphtholFor use as preservative of defoamer only.
Nonylphenol
Odorless light petroleum hydrocarbonsAs defined in 178.3650 of this chapter.
Oleic acid, sulfated, ammonium, potassium, or sodium salt
ParachlorometacresolFor use as preservative of defoamer only.
Peanut oil, sulfated, ammonium, potassium, or sodium salt
Petrolatum
Pine oil
Polyacrylic acid, sodium saltAs a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane.
Polyethylene
Polyethylene, oxidized
Polyethylene glycol (200) dilaurate
Polyethylene glycol (400) dioleate
Polyethylene glycol (600) dioleate
Polyethylene glycol (400) esters of coconut oil fatty acids
Polyethylene glycol (400) monooleate
Polyethylene glycol (600) monooleate
Polyethylene glycol (600) monoricinoleate
Polyethylene glycol (400) monostearate
Polyoxybutylene-polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 3,700)
Polyoxyethylated (min. 3 mols) cetyl alcohol
Polyoxyethylated (min. 5 mols) oleyl alcohol
Polyoxyethylated (min. 1.5 mols) tridecyl alcohol
Polyoxyethylene (min. 15 mols) ester of rosin
Polyoxyethylene (min. 8 mols) monooleate
Polyoxyethylene (40) stearate
Polyoxypropylated (min. 20 mols) butyl alcohol
Polyoxypropylene glycol (min. mol. wt. 200)
Polyoxypropylene (min. 20 mols) oleate butyl ether
Polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 1,900)
Polyoxypropylene (min. 40 mols) stearate butyl ether
Potassium pentachlorophenateFor use as preservative of defoamer only.
Potassium trichlorophenate Do.
Propylene glycol monoester of soybean oil fatty acids
Propylene glycol monoester of tallow fatty acids
Ricebran oil, sulfated, ammonium, potassium, or sodium salt
Rosins and rosin derivativesAs provided in 178.3870 of this chapter.
Silica
Sodium 2-mercaptobenzothiazoleFor use as preservative of defoamer only.
Sodium pentachlorophenate Do.
Sodium trichlorophenate Do.
Sperm oil, sulfated, ammonium, potassium, or sodium salt
Stearyl alcohol
Tall oil fatty acids
Tallow fatty acids, hydrogenated or sulfated
Tallow, sulfated, ammonium, potassium, or sodium salt
Triethanolamine
Triisopropanolamine
Waxes, petroleum

(e) The defoaming agents are used as follows:

(1) The quantity of defoaming agent or agents used shall not exceed the amount reasonably required to accomplish the intended effect, which is to prevent or control the formation of foam.

(2) The defoaming agents are used in the preparation and application of coatings for paper and paperboard.

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