GrokFood Home
Loading

173.340 Defoaming agents.

Home > Regulations > Secondary direct food additives permitted in food for human consumption > 173.340 Defoaming agents.



[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: 21CFR173.340]

[Page 144-146]
 
                        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 [deg]C;       for-consumption state will have
 viscosity 300 to 1,050 centistokes   not more than 10 parts per million
 at 25 [deg]C; refractive index       except as follows: Zero in milk;
 1.400-1.404 at 25 [deg]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.
[alpha]-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.
Butyl stearate.........................

[[Page 145]]


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)     10 percent by weight of
 of this chapter and providing the        defoamer formulation.
 oleic 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
 acids.                                   of 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 [deg]C (100
                                          [deg]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, 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.
------------------------------------------------------------------------


[[Page 146]]

    (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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 173, Section 340


Home | About | Search