21 CFR 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

α-(Dinonylphenyl)-ω-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.

Formaldehyde For 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

β-Naphthol For use as preservative of defoamer only.

Nonylphenol

Odorless light petroleum hydrocarbons As defined in § 178.3650 of this chapter.

Oleic acid, sulfated, ammonium, potassium, or sodium salt

Parachlorometacresol For use as preservative of defoamer only.

Peanut oil, sulfated, ammonium, potassium, or sodium salt

Petrolatum

Pine oil

Polyacrylic acid, sodium salt As 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 pentachlorophenate For 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 derivatives As provided in § 178.3870 of this chapter.

Silica

Sodium 2-mercaptobenzothiazole For 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.