[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR173.340] [Page 135-137] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION--Table of Contents Subpart D--Specific Usage Additives Sec. 173.340 Defoaming agents. Defoaming agents may be safely used in processing foods, in accordance with the following conditions: (a) They consist of one or more of the following: (1) Substances generally recognized by qualified experts as safe in food or covered by prior sanctions for the use prescribed by this section. (2) Substances listed in this paragraph (a)(2) of this section, subject to any limitations imposed: ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ Dimethylpolysiloxane (substantially 10 parts per million in food, or at free from hydrolyzable chloride such level in a concentrated food and alkoxy groups; no more than 18 that when prepared as directed on percent loss in weight after the labels, the food in its ready- heating 4 hours at 200 C; for-consumption state will have viscosity 300 to 1,050 centistokes not more than 10 parts per million at 25 C; refractive index 1.400- except as follows: Zero in milk; 1.404 at 25 C). 110 parts per million in dry gelatin dessert mixes labeled for use whereby no more than 16 parts per million is present in the ready-to-serve dessert; 250 parts per million in salt labeled for cooking purposes, whereby no more than 10 parts per million is present in the cooked food. Formaldehyde....................... As a preservative in defoaming agents containing dimethylpolysiloxane, in an amount not exceeding 1.0 percent of the dimethylpolysiloxane content. -Hydro-omega-hydroxy-poly For use as prescribed in Sec. (oxyethylene)/poly(oxypropylene) 172.808(b)(3) of this chapter. (minimum 15 moles)/ poly(oxyethylene) block copolymer (CAS Reg. No. 9003-11-6) as defined in Sec. 172.808(a)(3) of this chapter. Polyacrylic acid, sodium salt...... As a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane in an amount reasonably required to accomplish the intended effect. Polyethylene glycol................ As defined in Sec. 172.820 of this chapter. Polyoxyethylene 40 monostearate.... As defined in U.S.P. XVI. Polysorbate 60..................... As defined in Sec. 172.836 of this chapter. Polysorbate 65..................... As defined in Sec. 172.838 of this chapter. Propylene glycol alginate.......... As defined in Sec. 172.858 of this chapter. Silicon dioxide.................... As defined in Sec. 172.480 of this chapter. Sorbitan monostearate.............. As defined in Sec. 172.842 of this chapter. White mineral oil: Conforming with As a component of defoaming agents Sec. 172.878 of this chapter. for use in wash water for sliced potatoes at a level not to exceed 0.008 percent of the wash water. ------------------------------------------------------------------------ (3) Substances listed in this paragraph (a)(3), provided they are components of defoaming agents limited to use in processing beet sugar and yeast, and subject to any limitations imposed: ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ Aluminum stearate...................... As defined in Sec. 172.863 of this chapter. [[Page 136]] Butyl stearate......................... BHA.................................... As an antioxidant, not to exceed 0.1 percent by weight of defoamer. BHT.................................... Do. Calcium stearate....................... As defined in Sec. 172.863 of this chapter. Fatty acids............................ As defined in Sec. 172.860 of this chapter. Formaldehyde........................... As a preservative. Hydroxylated lecithin.................. As defined in Sec. 172.814 of this chapter. Isopropyl alcohol...................... Magnesium stearate..................... As defined in Sec. 172.863 of this chapter. Mineral oil: Conforming with Sec. Not more than 150 p.p.m. in 172.878 of this chapter. yeast, measured as hydrocarbons. Odorless light petroleum hydrocarbons: ............................... Conforming with Sec. 172.884 of this chapter. Petrolatum: Conforming with Sec. ............................... 172.880 of this chapter. Petroleum wax: Conforming with Sec. 172.886 of this chapter. Petroleum wax, synthetic............... Polyethylene glycol (400)dioleate: As an emulsifier not to exceed Conforming with Sec. 172.820(a)(2) of 10 percent by weight of this chapter and providing the oleic defoamer formulation. acid used in the production of this substance complies with Sec. 172.860 or Sec. 172.862 of this chapter. Synthetic isoparaffinic petroleum hydrocarbons: Conforming with Sec. 172.882 of this chapter. Oleic acid derived from tall oil fatty Complying with Sec. 172.862 of acids. this chapter. Oxystearin............................. As defined in Sec. 172.818 of this chapter. Polyoxyethylene (600) dioleate......... Polyoxyethylene (600) monoricinoleate.. Polypropylene glycol................... Molecular weight range, 1,200- 3,000. Polysorbate 80......................... As defined in Sec. 172.840 of this chapter. Potassium stearate..................... As defined in Sec. 172.863 of this chapter. Propylene glycol mono- and diesters of As defined in Sec. 172.856 of fats and fatty acids. this chapter. Soybean oil fatty acids, hydroxylated.. Tallow, hydrogenated, oxidized or sulfated. Tallow alcohol, hydrogenated........... ------------------------------------------------------------------------ (4) The substances listed in this paragraph (a)(4), provided they are components of defoaming agents limited to use in processing beet sugar only, and subject to the limitations imposed: ------------------------------------------------------------------------ Substances Limitations ------------------------------------------------------------------------ n-Butoxypoly(oxyethylene)- Viscosity range, 4,850-5,350 poly(oxypropylene)glycol. Saybolt Universal Seconds (SUS) at 37.8 C (100 F). The viscosity range is determined by the method ``Viscosity Determination of n- butoxypoly(oxyethylene)- poly(oxypropylene) glycol'' dated April 26, 1995, developed by Union Carbide Corp., P.O. Box 670, Bound Brook, NJ 08805, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the material incorporated by reference are available from the Division of Petition Control, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and may be examined at the Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. [[Page 137]] Monoester of alpha-hydro-omega-hydroxy- ............................ poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked copolymer derived from low erucic acid rapeseed oil. ------------------------------------------------------------------------ (b) They are added in an amount not in excess of that reasonably required to inhibit foaming. [42 FR 14526, Mar. 15, 1977, as amended at 43 FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR 29134, May 28, 1998]