176.200 Defoaming agents used in coatings.

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[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: 21CFR176.200] [Page 227-229] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 176_INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS--Table of Contents 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 Sec. 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. [[Page 228]] (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 For use only at levels not to fatty acids derived from: exceed 0.1% by weight of total coating solids. Animal and vegetable fats and oils. Tall oil. Dimethylpolysiloxane................... [alpha]-(Dinonylphenyl)-[omega]-hydroxy- For use only in defoaming poly(oxy-1,2-ethanediyl), containing 7 agents for the production of to 24 moles of ethylene oxide per mole styrene-butadiene coatings at of dinonylphenol (CAS Reg. No. 9014-93- a level not to exceed 0.05 1). 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................................ [beta]-Naphthol........................ For use as preservative of defoamer only. Nonylphenol............................ Odorless light petroleum hydrocarbons.. As defined in Sec. 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... [[Page 229]] 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 Sec. 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. [42 FR 14554, Mar. 15, 1977, as amended at 62 FR 39772, July 24, 1997]