[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: 21CFR176.200]
[Page 217-219]
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.
(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...................
-(Dinonylphenyl)-- For use only in defoaming
hydroxy-poly(oxy-1,2-ethanediyl), agents for the production of
containing 7 to 24 moles of ethylene styrene-butadiene coatings at
oxide per mole of dinonylphenol (CAS a level not to exceed 0.05
Reg. No. 9014-93-1). 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.................................
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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................................
-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...
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
[[Page 219]]
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]