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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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 176, Section 200


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