21 CFR 173.340 - Defoaming agents.

§ 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 free from hydrolyzable chloride and alkoxy groups; no more than 18 percent loss in weight after heating 4 hours at 200 °C; viscosity 300 to 1,050 centistokes at 25 °C; refractive index 1.400-1.404 at 25 °C) 10 parts per million in food, or at such level in a concentrated food that when prepared as directed on the labels, the food in its ready-for-consumption state will have not more than 10 parts per million except as follows: Zero in milk; 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.
α-Hydro-omega-hydroxy-poly (oxyethylene)/poly(oxypropylene) (minimum 15 moles)/poly(oxyethylene) block copolymer (CAS Reg. No. 9003-11-6) as defined in § 172.808(a)(3) of this chapter For use as prescribed in § 172.808(b)(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 § 172.820 of this chapter.
Polyoxyethylene 40 monostearate As defined in U.S.P. XVI.
Polysorbate 60 As defined in § 172.836 of this chapter.
Polysorbate 65 As defined in § 172.838 of this chapter.
Propylene glycol alginate As defined in § 172.858 of this chapter.
Silicon dioxide As defined in § 172.480 of this chapter.
Sorbitan monostearate As defined in § 172.842 of this chapter.
White mineral oil: Conforming with § 172.878 of this chapter As a component of defoaming agents 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 § 172.863 of this chapter.
Butyl stearate
BHA As an antioxidant, not to exceed 0.1 percent by weight of defoamer.
Calcium stearate As defined in § 172.863 of this chapter.
Fatty acids As defined in § 172.860 of this chapter.
Formaldehyde As a preservative.
Hydroxylated lecithin As defined in § 172.814 of this chapter.
Isopropyl alcohol
Magnesium stearate As defined in § 172.863 of this chapter.
Mineral oil: Conforming with § 172.878 of this chapter Not more than 150 p.p.m. in yeast, measured as hydrocarbons.
Odorless light petroleum hydrocarbons: Conforming with § 172.884 of this chapter
Petrolatum: Conforming with § 172.880 of this chapter
Petroleum wax: Conforming with § 172.886 of this chapter
Petroleum wax, synthetic
Polyethylene glycol (400)dioleate: Conforming with § 172.820(a)(2) of this chapter and providing the oleic acid used in the production of this substance complies with § 172.860 or § 172.862 of this chapter As an emulsifier not to exceed 10 percent by weight of defoamer formulation.
Synthetic isoparaffinic petroleum hydrocarbons: Conforming with § 172.882 of this chapter
Oleic acid derived from tall oil fatty acids Complying with § 172.862 of this chapter.
Oxystearin As defined in § 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 § 172.840 of this chapter.
Potassium stearate As defined in § 172.863 of this chapter.
Propylene glycol mono- and diesters of fats and fatty acids As defined in § 172.856 of 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)-poly(oxypropylene)glycol Viscosity range, 4,850-5,350 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 1 CFR part 51. Copies of the material incorporated by reference are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, and may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
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; 81 FR 5592, Feb. 3, 2016]

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