• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-
New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2013]
[CITE: 21CFR173.340]



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 173 -- SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

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:

SubstancesLimitations
Dimethylpolysiloxane (substantially free from hydrolyzable chloride and alkoxy groups; no more than 18 percent loss in weight after heating 4 hours at 200 deg. C; viscosity 300 to 1,050 centistokes at 25 deg. C; refractive index 1.400-1.404 at 25 deg. 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.
FormaldehydeAs a preservative in defoaming agents containing dimethylpolysiloxane, in an amount not exceeding 1.0 percent of the dimethylpolysiloxane content.
[alpha]-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 chapterFor use as prescribed in 172.808(b)(3) of this chapter.
Polyacrylic acid, sodium saltAs a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane in an amount reasonably required to accomplish the intended effect.
Polyethylene glycolAs defined in 172.820 of this chapter.
Polyoxyethylene 40 monostearateAs defined in U.S.P. XVI.
Polysorbate 60As defined in 172.836 of this chapter.
Polysorbate 65As defined in 172.838 of this chapter.
Propylene glycol alginateAs defined in 172.858 of this chapter.
Silicon dioxideAs defined in 172.480 of this chapter.
Sorbitan monostearateAs defined in 172.842 of this chapter.
White mineral oil: Conforming with 172.878 of this chapterAs 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:

SubstancesLimitations
Aluminum stearateAs defined in 172.863 of this chapter.
Butyl stearate
BHAAs an antioxidant, not to exceed 0.1 percent by weight of defoamer.
BHT Do.
Calcium stearateAs defined in 172.863 of this chapter.
Fatty acidsAs defined in 172.860 of this chapter.
FormaldehydeAs a preservative.
Hydroxylated lecithinAs defined in 172.814 of this chapter.
Isopropyl alcohol
Magnesium stearateAs defined in 172.863 of this chapter.
Mineral oil: Conforming with 172.878 of this chapterNot 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 chapterAs 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 acidsComplying with 172.862 of this chapter.
OxystearinAs defined in 172.818 of this chapter.
Polyoxyethylene (600) dioleate
Polyoxyethylene (600) monoricinoleate
Polypropylene glycolMolecular weight range, 1,200-3,000.
Polysorbate 80As defined in 172.840 of this chapter.
Potassium stearateAs defined in 172.863 of this chapter.
Propylene glycol mono- and diesters of fats and fatty acidsAs 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:

SubstancesLimitations
n-Butoxypoly(oxyethylene)-poly(oxypropylene)glycolViscosity range, 4,850-5,350 Saybolt Universal Seconds (SUS) at 37.8 deg. C (100 deg. F). The viscosity range is determined by the method "Viscosity Determination ofn-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, 5100 Paint Branch Pkwy., College Park, MD 20740, 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]

-
-