Code of Federal Regulations: 21 CFR 173 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

This electronic document was downloaded from the GPO web site, November 2003, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated April 1 of each year. The most current version of the regulations may be found at the GPO web site.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173]

[Page 116-117]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec.
173.5 Acrylate-acrylamide resins.
173.10 Modified polyacrylamide resin.
173.20 Ion-exchange membranes.
173.21 Perfluorinated ion exchange membranes.
173.25 Ion-exchange resins.
173.40 Molecular sieve resins.
173.45 Polymaleic acid and its sodium salt.
173.50 Polyvinylpolypyrrolidone.

[[Page 117]]

173.55 Polyvinylpyrrolidone.
173.60 Dimethylamine-epichlorohydrin copolymer.
173.65 Divinylbenzene copolymer.
173.70 Chloromethylated aminated styrene-divinylbenzene resin.
173.73 Sodium polyacrylate.
173.75 Sorbitan monooleate.

Subpart B--Enzyme Preparations and Microorganisms

173.110 Amyloglucosidase derived from Rhizopus niveus.
173.115 Alpha-acetolactate decarboxylase ([alpha]-ALDC) enzyme
preparation derived from a recombinant Bacillus subtilis.
173.120 Carbohydrase and cellulase derived from Aspergillus niger.
173.130 Carbohydrase derived from Rhizopus oryzae.
173.135 Catalase derived from Microccocus lysodeikticus.
173.140 Esterase-lipase derived from Mucor miehei.
173.145 Alpha-Galactosidase derived from Mortierella vinaceae var.
raffinoseutilizer.
173.150 Milk-clotting enzymes, microbial.
173.160 Candida guilliermondii.
173.165 Candida lipolytica.
173.170 Aminoglycoside 3'-phosphotransferase II.

Subpart C--Solvents, Lubricants, Release Agents and Related Substances

173.210 Acetone.
173.220 1,3-Butylene glycol.
173.228 Ethyl acetate.
173.230 Ethylene dichloride.
173.240 Isopropyl alcohol.
173.250 Methyl alcohol residues.
173.255 Methylene chloride.
173.270 Hexane.
173.275 Hydrogenated sperm oil.
173.280 Solvent extraction process for citric acid.
173.290 Trichloroethylene.

Subpart D--Specific Usage Additives

173.300 Chlorine dioxide.
173.310 Boiler water additives.
173.315 Chemicals used in washing or to assist in the peeling of fruits
and vegetables.
173.320 Chemicals for controlling microorganisms in cane-sugar and
beet-sugar mills.
173.322 Chemicals used in delinting cottonseed.
173.325 Acidified sodium chlorite solutions.
173.340 Defoaming agents.
173.342 Chlorofluorocarbon 113 and perfluorohexane.
173.345 Chloropentafluoroethane.
173.350 Combustion product gas.
173.355 Dichlorodifluoromethane.
173.357 Materials used as fixing agents in the immobilization of enzyme
preparations.
173.360 Octafluorocyclobutane.
173.368 Ozone.
173.370 Peroxyacids.
173.385 Sodium methyl sulfate.
173.395 Trifluoromethane sulfonic acid.
173.400 Dimethyldialkylammonium chloride.

Authority: 21 U.S.C. 321, 342, 348.

Source: 42 FR 14526, Mar. 15, 1977, unless otherwise noted.

Editorial Note: Nomenclature changes to part 173 appear at 61 FR
14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec.
27, 2001.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.5]

[Page 117-118]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.5 Acrylate-acrylamide resins.

Acrylate-acrylamide resins may be safely used in food under the
following prescribed conditions:
(a) The additive consists of one of the following:
(1) Acrylamide-acrylic acid resin (hydrolyzed polyacrylamide) is
produced by the polymerization of acrylamide with partial hydrolysis, or
by copolymerization of acrylamide and acrylic acid, with the greater
part of the polymer being composed of acrylamide units.
(2) Sodium polyacrylate-acrylamide resin is produced by the
polymerization and subsequent hydrolysis of acrylonitrile in a sodium
silicate-sodium hydroxide aqueous solution, with the greater part of the
polymer being composed of acrylate units.
(b) The additive contains not more than 0.05 percent of residual
monomer calculated as acrylamide.
(c) The additive is used or intended for use as follows:
(1) The additive identified in paragraph (a) (1) of this section is
used as a flocculent in the clarification of beet sugar juice and liquor
or cane sugar juice and liquor or corn starch hydrolyzate in an amount
not to exceed 5 parts per million by weight of the juice or 10 parts per
million by weight of the liquor or the corn starch hydrolyzate.

[[Page 118]]

(2) The additive identified in paragraph (a)(2) of this section is
used to control organic and mineral scale in beet sugar juice and liquor
or cane sugar juice and liquor in an amount not to exceed 2.5 parts per
million by weight of the juice or liquor.

[42 FR 14526, Mar. 15, 1977, as amended at 46 FR 30494, June 9, 1981]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.10]

[Page 118]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.10 Modified polyacrylamide resin.

Modified polyacrylamide resin may be safely used in food in
accordance with the following prescribed conditions:
(a) The modified polyacrylamide resin is produced by the
copolymerization of acrylamide with not more than 5-mole percent [beta]-
methacrylyloxyethy-ltrimethylammonium methyl sulfate.
(b) The modified polyacrylamide resin contains not more than 0.05
percent residual acrylamide.
(c) The modified polyacrylamide resin is used as a flocculent in the
clarification of beet or cane sugar juice in an amount not exceeding 5
parts per million by weight of the juice.
(d) To assure safe use of the additive, the label and labeling of
the additive shall bear, in addition to the other information required
by the act, adequate directions to assure use in compliance with
paragraph (c) of this section.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.20]

[Page 118]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.20 Ion-exchange membranes.

Ion-exchange membranes may be safely used in the processing of food
under the following prescribed conditions:
(a) The ion-exchange membrane is prepared by subjecting a
polyethylene base conforming to Sec. 177.1520 of this chapter to
polymerization with styrene until the polystyrene phase of the base is
not less than 16 percent nor more than 30 percent by weight. The base is
then modified by reaction with chloromethyl methyl ether, and by
subsequent amination with trimethylamine, dimethylamine,
diethylenetriamine, or dimethylethanolamine.
(b) The ion-exchange membrane is manufactured so as to comply with
the following extraction limitations when subjected to the described
procedure: Separate square-foot samples of membrane weighing
approximately 14 grams each are cut into small pieces and refluxed for 4
hours in 150 cubic centimeters of the following solvents: Distilled
water, 5 percent acetic acid, and 50 percent alcohol. Extraction from
each sample will not exceed 0.4 percent by weight of sample.
(c) The ion-exchange membrane will be used in the production of
grapefruit juice to adjust the ratio of citric acid to total solids of
the grapefruit juice produced.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.21]

[Page 118-119]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.21 Perfluorinated ion exchange membranes.

Substances identified in paragraph (a) of this section may be safely
used as ion exchange membranes intended for use in the treatment of bulk
quantities of liquid food under the following prescribed conditions:
(a) Identity. The membrane is a copolymer of ethanesulfonyl
fluoride, 2-[1-[difluoro-[(trifluoroethenyl)oxy]methyl]-1,2,2,2-
tetrafluoroethoxy]-1,1,2,2,-tetrafluoro-, with tetrafluoroethylene that
has been subsequently treated to hydrolyze the sulfonyl fluoride group
to the sulfonic acid. The Chemical Abstracts Service name of this
polymer is ethanesulfonic acid, 2-[1-[difluoro-
[(trifluoroethenyl)oxy]methyl]-1,2,2,2-tetrafluoroethoxy]-1,1,2,2,-
tetrafluoro-, polymer with tetrafluoroethane (CAS Reg. No. 31175-20-9).
(b) Optional adjuvant substances. The basic polymer identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic polymer. These optional
adjuvant substances may include substances used in accordance with
Sec. 174.5 of this chapter.
(c) Conditions of use. (1) Perfluorinated ion exchange membranes
described in paragraph (a) of this section may be used in contact with
all types of liquid foods at temperatures not exceeding 70 deg. (158
deg.F).
(2) Maximum thickness of the copolymer membrane is 0.007 inch (0.017
centimeter).
(3) Perfluorinated ion exchange membranes shall be maintained in a
sanitary manner in accordance with current good manufacturing practice
so as

[[Page 119]]

to prevent microbial adulteration of food.
(4) To assure their safe use, perfluorinated ionomer membranes shall
be thoroughly cleaned prior to their first use in accordance with
current good manufacturing practice.

[59 FR 15623, Apr. 4, 1994]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.25]

[Page 119-122]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.25 Ion-exchange resins.

Ion-exchange resins may be safely used in the treatment of food
under the following prescribed conditions:
(a) The ion-exchange resins are prepared in appropriate physical
form, and consist of one or more of the following:
(1) Sulfonated copolymer of styrene and divinylbenzene.
(2) Sulfonated anthracite coal meeting the requirements of ASTM
method D388-38, Class I, Group 2, "Standard Specifications for
Classification of Coal by Rank," which is incorporated by reference.
Copies are available from University Microfilms International, 300 N.
Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(3) Sulfite-modified cross-linked phenol-formaldehyde, with
modification resulting in sulfonic acid groups on side chains.
(4) Methacrylic acid-divinylbenzene copolymer.
(5) Cross-linked polystyrene, first chloromethylated then aminated
with trimethylamine, dimethylamine, di-ethylenetriamine, or
dimethylethanol-amine.
(6) Diethylenetriamine, triethylene-tetramine, or
tetraethylenepentamine cross-linked with epichlorohydrin.
(7) Cross-linked phenol-formaldehyde activated with one or both of
the following: Triethylene tetramine and tetraethylenepentamine.
(8) Reaction resin of formaldehyde, acetone, and
tetraethylenepentamine.
(9) Completely hydrolyzed copolymers of methyl acrylate and
divinylbenzene.
(10) Completely hydrolyzed terpolymers of methyl acrylate,
divinylbenzene, and acrylonitrile.
(11) Sulfonated terpolymers of styrene, divinylbenzene, and
acrylonitrile or methyl acrylate.
(12) Methyl acrylate-divinylbenzene copolymer containing not less
than 2 percent by weight of divinylbenzene, aminolyzed with
dimethylaminopro-pylamine.
(13) Methyl acrylate-divinylbenzene copolymer containing not less
than 3.5 percent by weight of divinylbenzene, aminolyzed with
dimethylaminopro-pylamine.
(14) Epichlorohydrin cross-linked with ammonia.
(15) Sulfonated tetrapolymer of styrene, divinylbenzene,
acrylonitrile, and methyl acrylate derived from a mixture of monomers
containing not more than a total of 2 percent by weight of acrylonitrile
and methyl acrylate.
(16) Methyl acrylate-divinylbenzenediethylene glycol divinyl ether
terpolymer containing not less than 3.5 percent by weight of
divinylbenzene and not more than 0.6 percent by weight of diethylene
glycol divinyl ether, aminolyzed with dimethylaminopropylamine.
(17) Styrene-divinylbenzene cross-linked copolymer, first
chloromethylated then aminated with dimethylamine and oxidized with
hydrogen peroxide whereby the resin contains not more than 15 percent by
weight of vinyl N,N-dimethylbenzylamine-N-oxide and not more than 6.5
percent by weight of nitrogen.
(18) Methyl acrylate-divinylbenzene-diethylene glycol divinyl ether
terpolymer containing not less than 7 percent by weight of
divinylbenzene and not more than 2.3 percent by weight of diethylene
glycol divinyl ether, aminolyzed with dimethylaminopropylamine and
quaternized with methyl chloride.
(19) Epichlorohydrin cross-linked with ammonia and then quaternized
with methyl chloride to contain not more than 18 percent strong base
capacity by weight of total exchange capacity [Chemical Abstracts
Service name: Oxirane (chloromethyl)-, polymer with ammonia, reaction
product with chloromethane; CAS Reg. No. 68036-99-7].

[[Page 120]]

(20) Regenerated cellulose, cross-linked and alkylated with
epichlorohydrin and propylene oxide, then sulfonated whereby the amount
of epichlorohydrin plus propylene oxide employed does not exceed 250
percent by weight of the starting quantity of cellulose.
(b) Ion-exchange resins are used in the purification of foods,
including potable water, to remove undesirable ions or to replace less
desirable ions with one or more of the following: bicarbonate, calcium,
carbonate, chloride, hydrogen, hydroxyl, magnesium, potassium, sodium,
and sulfate except that: The ion-exchange resin identified in paragraph
(a)(12) of this section is used only in accordance with paragraph (b)(1)
of this section, the ion-exchange resin identified in paragraph (a)(13)
of this section is used only in accordance with paragraph (b)(2) of this
section, the resin identified in paragraph (a)(16) of this section is
used only in accordance with paragraph (b)(1) or (b)(2) of this section,
the ion-exchange resin identified in paragraph (a)(17) of this section
is used only in accordance with paragraph (b)(3) of this section, the
ion-exchange resin identified in paragraph (a)(18) of this section is
used only in accordance with paragraph (b)(4) of this section, and the
ion-exchange resin identified in paragraph (a)(20) of this section is
used only in accordance with paragraphs (b)(5) and (d) of this section.
(1) The ion-exchange resins identified in paragraphs (a) (12) and
(16) of this section are used to treat water for use in the manufacture
of distilled alcoholic beverages, subject to the following conditions:
(i) The water is subjected to treatment through a mixed bed
consisting of one of the resins identified in paragraph (a) (12) or (16)
of this section and one of the strongly acidic cation-exchange resins in
the hydrogen form identified in paragraphs (a) (1), (2), and (11) of
this section; or
(ii) The water is first subjected to one of the resins identified in
paragraph (a) (12) or (16) of this section and is subsequently subjected
to treatment through a bed of activated carbon or one of the strongly
acidic cation-exchange resins in the hydrogen form identified in
paragraphs (a) (1), (2), and (11) of this section.
(iii) The temperature of the water passing through the resin beds
identified in paragraphs (b)(1) (i) and (ii) of this section is
maintained at 30 deg.C or less, and the flow rate of the water passing
through the beds is not less than 2 gallons per cubic foot per minute.
(iv) The ion-exchange resins identified in paragraph (a) (12) or
(16) of this section are exempted from the requirements of paragraph
(c)(4) of this section, but the strongly acidic cation-exchange resins
referred to in paragraphs (b)(1) (i) and (ii) of this section used in
the process meet the requirements of paragraph (c)(4) of this section,
except for the exemption described in paragraph (d) of this section.
(2) The ion-exchange resins identified in paragraphs (a) (13) and
(16) of this section are used to treat water and aqueous food only of
the types identified under Categories I, II, and VI-B in table 1 of
Sec. 176.170(c) of this chapter: Provided, That the temperature of the
water or food passing through the resin beds is maintained at 50 deg.C
or less and the flow rate of the water or food passing through the beds
is not less than 0.5 gallon per cubic foot per minute.
(i) The ion-exchange resin identified in paragraph (a)(13) of this
section is used to treat water and aqueous food only of the types
identified under categories I, II, and VI-B in Table 1 of
Sec. 176.170(c) of this chapter: Provided, That the temperature of the
water or food passing through the resin bed is maintained at 50 deg.C
or less and the flow rate of the water or food passing through the bed
is not less than 0.5 gallon per cubic foot per minute.
(ii) The ion-exchange resin identified in paragraph (a)(16) of this
section is used to treat water and aqueous food only of the types
identified under categories I, II, and VI-B in Table 1 of
Sec. 176.170(c) of this chapter, Provided, that either:
(A) The temperature of the water or food passing through the resin
bed is maintained at 50 deg.C or less and the flow rate of the water or
food passing through the bed is not less than 0.5 gallon per cubic foot
per minute; or

[[Page 121]]

(B) Extracts of the resin will be found to contain no more than 1
milligram/kilogram dimethylaminopropylamine in each of the food
simulants, distilled water and 10 percent ethanol, when, following
washing and pretreatment of the resin in accordance with
Sec. 173.25(c)(1), the resin is subjected to the following test under
conditions simulating the actual temperature and flow rate of use: "The
Determination of 3-Dimethylaminopropylamine in Food Simulating Extracts
of Ion Exchange Resins," February 4, 1998, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
are available from the Division of Petition Control (HFS-215), Center
for Food Safety and Applied Nutrition, Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or 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 Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(3) The ion-exchange resin identified in paragraph (a)(17) of this
section is used only for industrial application to treat bulk quantities
of aqueous food, including potable water, or for treatment of municipal
water supplies, subject to the condition that the temperature of the
food or water passing through the resin bed is maintained at 25 deg.C
or less and the flow rate of the food or water passing through the bed
is not less than 2 gallons per cubic foot per minute.
(4) The ion-exchange resin identified in paragraph (a)(18) of this
section is used to treat aqueous sugar solutions subject to the
condition that the temperature of the sugar solution passing through the
resin bed is maintained at 82 deg.C (179.6 deg.F) or less and the flow
rate of the sugar solution passing through the bed is not less than 46.8
liters per cubic meter (0.35 gallon per cubic foot) of resin bed volume
per minute.
(5) The ion-exchange resin identified in paragraph (a)(20) of this
section is limited to use in aqueous process streams for the isolation
and purification of protein concentrates and isolates under the
following conditions:
(i) For resins that comply with the requirements in paragraph
(d)(2)(i) of this section, the pH range for the resin shall be no less
than 3.5 and no more than 9, and the temperatures of water and food
passing through the resin bed shall not exceed 25 deg.C.
(ii) For resins that comply with the requirements in paragraph
(d)(2)(ii) of this section, the pH range for the resin shall be no less
than 2 and no more than 10, and the temperatures of water and food
passing through the resin shall not exceed 50 deg.C.
(c) To insure safe use of ion-exchange resins, each ion-exchange
resin will be:
(1) Subjected to pre-use treatment by the manufacturer and/or the
user in accordance with the manufacturer's directions prescribed on the
label or labeling accompanying the resins, to guarantee a food-grade
purity of ion-exchange resins, in accordance with good manufacturing
practice.
(2) Accompanied by label or labeling to include directions for use
consistent with the intended functional purpose of the resin.
(3) Used in compliance with the label or labeling required by
paragraph (c)(2) of this section.
(4) Found to result in no more than 1 part per million of organic
extractives obtained with each of the named solvents, distilled water,
15 percent alcohol, and 5 percent acetic acid when, having been washed
and otherwise treated in accordance with the manufacturer's directions
for preparing them for use with food, the ion-exchange resin is
subjected to the following test: Using a separate ion-exchange column
for each solvent, prepare columns using 50 milliliters of the ready to
use ion-exchange resin that is to be tested. While maintaining the
highest temperature that will be encountered in use pass through these
beds at the rate of 350-450 milliliters per hour the three test solvents
distilled water, 15 percent (by volume) ethyl alcohol, and 5 percent (by
weight) acetic acid. The first liter of effluent from each solvent is
discarded, then the next 2 liters are used to determine organic
extractives. The 2-liter sample is carefully evaporated to constant
weight at 105 deg.C; this is total extractives. This residue is fired
in a muffle

[[Page 122]]

furnace at 850 deg.C to constant weight; this is ash. Total
extractives, minus ash equals the organic extractives. If the organic
extractives are greater than 1 part per million of the solvent used, a
blank should be run on the solvent and a correction should be made by
subtracting the total extractives obtained with the blank from the total
extractives obtained in the resin test. The solvents used are to be made
as follows:

Distilled water (de-ionized water is distilled).
15 percent ethyl alcohol made by mixing 15 volumes of absolute ethyl
alcohol A.C.S. reagent grade, with 85 volumes of distilled de-ionized
water.
5 percent acetic acid made by mixing 5 parts by weight of A.C.S. reagent
grade glacial acetic acid with 95 parts by weight of distilled de-
ionized water.

In addition to the organic extractives limitation prescribed in this
paragraph, the ion-exchange resin identified in paragraph (a)(17) of
this section, when extracted with each of the named solvents, distilled
water, 50 percent alcohol, and 5 percent acetic acid, will be found to
result in not more than 7 parts per million of nitrogen extractives
(calculated as nitrogen) when the resin in the free-base form is
subjected to the following test immediately before each use: Using a
separate 1-inch diameter glass ion-exchange column for each solvent,
prepare each column using 100 milliliters of ready to use ion-exchange
resin that is to be tested. With the bottom outlet closed, fill each
ion-exchange column with one of the three solvents at a temperature of
25 deg.C until the solvent level is even with the top of the resin bed.
Seal each column at the top and bottom and store in a vertical position
at a temperature of 25 deg.C. After 96 hours, open the top of each
column, drain the solvent into a collection vessel, and analyze each
drained solvent and a solvent blank for nitrogen by a standard micro-
Kjeldahl method.
(d)(1) The ion-exchange resins identified in paragraphs (a)(1),
(a)(2), (a)(11), and (a)(15) of this section are exempted from the
acetic acid extraction requirement of paragraph (c)(4) of this section.
(2) The ion-exchange resin identified in paragraph (a)(20) of this
section shall comply either with:
(i) The extraction requirement in paragraph (c)(4) of this section
by using dilute sulfuric acid, pH 3.5 as a substitute for acetic acid;
or
(ii) The extraction requirement in paragraph (c)(4) of this section
by using reagent grade hydrochloric acid, diluted to pH 2, as a
substitute for acetic acid. The resin shall be found to result in no
more than 25 parts per million of organic extractives obtained with each
of the following solvents: Distilled water; 15 percent alcohol; and
hydrochloric acid, pH 2. Blanks should be run for each of the solvents,
and corrections should be made by subtracting the total extractives
obtained with the blank from the total extractives obtained in the resin
test.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14526, Mar. 15, 1977, as amended at 46 FR 40181, Aug. 7, 1981; 46
FR 57033, Nov. 20, 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, Apr.
22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR 14609, Mar. 26, 1999; 64 FR
56173, Oct. 18, 1999]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.40]

[Page 122]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.40 Molecular sieve resins.

Molecular sieve resins may be safely used in the processing of food
under the following prescribed conditions:
(a) The molecular sieve resins consist of purified dextran having an
average molecular weight of 40,000, cross-linked with epichlorohydrin in
a ratio of 1 part of dextran to 10 parts of epichlorohydrin, to give a
stable three dimensional structure. The resins have a pore size of 2.0
to 3.0 milliliters per gram of dry resin (expressed in terms of water
regain), and a particle size of 10 to 300 microns.
(b) The molecular sieve resins are thoroughly washed with potable
water prior to their first use in contact with food.
(c) Molecular sieve resins are used as the gel filtration media in
the final purification of partially delactosed whey. The gel bed shall
be maintained in a sanitary manner in accordance with good manufacturing
practice so as to prevent microbial build-up on the bed and adulteration
of the product.

[[Page 123]]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.45]

[Page 123]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.45 Polymaleic acid and its sodium salt.

Polymaleic acid (CAS Reg. No. 26099-09-2) and its sodium salt (CAS
Reg. No. 70247-90-4) may be safely used in food in accordance with the
following prescribed conditions:
(a) The additives have a weight-average molecular weight in the
range of 540 to 850 and a number-average molecular weight in the range
of 520 to 650, calculated as the acid. Molecular weights shall be
determined by a method entitled "Determination of Molecular Weight
Distribution of Poly(Maleic) Acid," March 17, 1992, produced by Ciba-
Geigy, Inc., Seven Skyline Dr., Hawthorne, NY 10532-2188, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Division of Product Policy,
Center for Food Safety and Applied Nutrition (HFS-205), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or are
available for inspection at the Center for Food Safety and Applied
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or
at the Office of the Federal Register, 800 North Capitol St. NW., suite
700, Washington, DC.
(b) The additives may be used, individually or together, in the
processing of beet sugar juice and liquor or of cane sugar juice and
liquor to control mineral scale.
(c) The additives are to be used so that the amount of either or
both additives does not exceed 4 parts per million (calculated as the
acid) by weight of the beet or cane sugar juice or liquor process
stream.

[51 FR 5315, Feb. 13, 1986, as amended at 61 FR 386, Jan. 5, 1996]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.50]

[Page 123]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.50 Polyvinylpolypyrrolidone.

The food additive polyvinylpolypyrrolidone may be safely used in
accordance with the following prescribed conditions:
(a) The additive is a homopolymer of purified vinylpyrrolidone
catalytically produced under conditions producing polymerization and
cross-linking such that an insoluble polymer is produced.
(b) The food additive is so processed that when the finished polymer
is refluxed for 3 hours with water, 5 percent acetic acid, and 50
percent alcohol, no more than 50 parts per million of extractables is
obtained with each solvent.
(c) It is used or intended for use as a clarifying agent in
beverages and vinegar, followed by removal with filtration.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.55]

[Page 123]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.55 Polyvinylpyrrolidone.

The food additive polyvinylpyrroli-done may be safely used in
accordance with the following prescribed conditions:
(a) The additive is a polymer of purified vinylpyrrolidone
catalytically produced, having an average molecular weight of 40,000 and
a maximum unsaturation of 1 percent, calculated as the monomer, except
that the polyvinylpyrrolidone used in beer is that having an average
molecular weight of 360,000 and a maximum unsaturation of 1 percent,
calculated as the monomer.
(b) The additive is used or intended for use in foods as follows:

------------------------------------------------------------------------
Food Limitations
------------------------------------------------------------------------
Beer............................ As a clarifying agent, at a residual
level not to exceed 10 parts per
million.
Flavor concentrates in tablet As a tableting adjuvent in an amount
form. not to exceed good manufacturing
practice.
Nonnutritive sweeteners in As a stabilizer, bodying agent, and
concentrated liquid form. dispersant, in an amount not to
exceed good manufacturing practice.
Nonnutritive sweeteners in As a tableting adjuvant in an amount
tablet form. not to exceed good manufacturing
practice.
Vitamin and mineral concentrates As a stabilizer, bodying agent, and
in liquid form. dispersant, in an amount not to
exceed good manufacturing practice.
Vitamin and mineral concentrates As a tableting adjuvant in an amount
in tablet form. not to exceed good manufacturing
practice.
Vinegar......................... As a clarifying agent, at a residual
level not to exceed 40 parts per
million.
Wine............................ As a clarifying agent, at a residual
level not to exceed 60 parts per
million.
------------------------------------------------------------------------

[[Page 124]]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.60]

[Page 124]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.60 Dimethylamine-epichlorohydrin copolymer.

Dimethylamine-epichlorohydrin copolymer (CAS Reg. No. 25988-97-0)
may be safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is produced by copolymerization of
dimethylamine and epichlorohydrin in which not more than 5 mole-percent
of dimethylamine may be replaced by an equimolar amount of
ethylenediamine, and in which the mole ratio of total amine to
epichlorohydrin is approximately 1:1.
(b) The additive meets the following specifications:
(1) The nitrogen content of the copolymer is 9.4 to 10.8 weight
percent on a dry basis.
(2) A 50-percent-by-weight aqueous solution of the copolymer has a
minimum viscosity of 175 centipoises at 25 deg.C as determined by LVT-
series Brookfield viscometer using a No. 2 spindle at 60 RPM (or by
another equivalent method).
(3) The additive contains not more than 1,000 parts per million of
1,3-dichloro-2-propanol and not more than 10 parts per million
epichlorohydrin. The epichlorohydrin and 1,3-dichloro-2-propanol content
is determined by an analytical method entitled "The Determination of
Epichlorohydrin and 1,3-Dichloro-2-Propanol in Dimethylamine-
Epichlorohydrin Copolymer," which is incorporated by reference. Copies
are available from the Center for Food Safety and Applied Nutrition
(HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
(4) Heavy metals (as Pb), 2 parts per million maximum.
(5) Arsenic (as As), 2 parts per million maximum.
(c) The food additive is used as a decolorizing agent and/or
flocculant in the clarification of refinery sugar liquors and juices. It
is added only at the defecation/clarification stage of sugar liquor
refining at a concentration not to exceed 150 parts per million of
copolymer by weight of sugar solids.
(d) To assure safe use of the additive, the label and labeling of
the additive shall bear, in addition to other information required by
the Act, adequate directions to assure use in compliance with paragraph
(c) of this section.

[48 FR 37614, Aug. 19, 1983, as amended at 54 FR 24897, June 12, 1989]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.65]

[Page 124]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.65 Divinylbenzene copolymer.

Divinylbenzene copolymer may be used for the removal of organic
substances from aqueous foods under the following prescribed conditions:
(a) The copolymer is prepared in appropriate physical form and is
derived by the polymerization of a grade of divinylbenzene which
comprises at least 79 weight-percent divinylbenzene, 15 to 20 weight-
percent ethylvinylbenzene, and no more than 4 weight-percent
nonpolymerizable impurities.
(b) In accordance with the manufacturer's directions, the copolymer
described in paragraph (a) of this section is subjected to pre-use
extraction with a water soluble alcohol until the level of
divinylbenzene in the extract is less than 50 parts per billion as
determined by a method titled, "The Determination of Divinylbenzene in
Alcohol Extracts of Amberlite XAD-4," which is incorporated by
reference. Copies of this method are available from the Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408. The copolymer is then
treated with water according to the manufacturer's recommendation to
remove the extraction solvent to guarantee a food-grade purity of the
resin at the time of use, in accordance with current good manufacturing
practice.
(c) The temperature of the aqueous food stream contacting the
polymer is maintained at 79.4 deg.C (175 deg.F) or less.
(d) The copolymer may be used in contact with food only of Types I,
II, and VI-B (excluding carbonated beverages) described in table 1 of
paragraph (c) of Sec. 176.170 of this chapter.

[50 FR 61, Jan. 2, 1985]

[[Page 125]]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.70]

[Page 125]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.70 Chloromethylated aminated styrene-divinylbenzene resin.

Chloromethylated aminated styrene-divinylbenzene copolymer (CAS Reg.
No. 60177-39-1) may be safely used in food in accordance with the
following prescribed conditions:
(a) The additive is an aqueous dispersion of styrene-divinylbenzene
copolymers, first chloromethylated then aminated with trimethylamine,
having an average particle size of not more than 2.0 microns.
(b) The additive shall contain no more than 3.0 percent nonvolatile,
soluble extractives when tested as follows: One hundred grams of the
additive is centrifuged at 17,000 r/min for 2 hours. The resulting clear
supernatant is removed from the compacted solids and concentrated to
approximately 10 grams on a steam bath. The 10-gram sample is again
centrifuged at 17,000 r/min for 2 hours to remove any residual insoluble
material. The supernatant from the second centrifugation is then removed
from any compacted solids and dried to constant residual weight using a
steam bath. The percent nonvolatile solubles is obtained by dividing the
weight of the dried residue by the weight of the solids in the original
resin dispersion.
(c) The additive is used as a decolorizing and clarification agent
for treatment of refinery sugar liquors and juices at levels not to
exceed 500 parts of additive solids per million parts of sugar solids.

[50 FR 29209, July 18, 1985]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.73]

[Page 125]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.73 Sodium polyacrylate.

Sodium polyacrylate (CAS Reg. No. 9003-04-7) may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive is produced by the polymerization of acrylic acid
and subsequent hydrolysis of the polyacrylic acid with an aqueous sodium
hydroxide solution. As determined by a method entitled "Determination
of Weight Average and Number Average Molecular Weight of Sodium
Polyacrylate," which is incorporated by reference in accordance with 5
U.S.C. 552(a), the additive has--
(1) A weight average molecular weight of 2,000 to 2,300; and
(2) A weight average molecular weight to number average molecular
weight ratio of not more than 1.3. Copies of the method are available
from the Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(b) The additive is used to control mineral scale during the
evaporation of beet sugar juice or cane sugar juice in the production of
sugar in an amount not to exceed 3.6 parts per million by weight of the
raw juice.

[53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, 1988]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.75]

[Page 125]

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 A--Polymer Substances and Polymer Adjuvants for Food Treatment

Sec. 173.75 Sorbitan monooleate.

Sorbitan monooleate may be safely used in accordance with the
following prescribed conditions:
(a) The additive is produced by the esterification of sorbitol with
commercial oleic acid.
(b) It meets the following specifications:
(1) Saponification number, 145-160.
(2) Hydroxyl number, 193-210.
(c) The additive is used or intended for use as follows:
(1) As an emulsifier in polymer dispersions that are used in the
clarification of cane or beet sugar juice or liquor in an amount not to
exceed 7.5 percent by weight in the final polymer dispersion.
(2) The additive is used in an amount not to exceed 0.70 part per
million in sugar juice and 1.4 parts per million in sugar liquor.

[51 FR 11720, Apr. 7, 1986]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.110]

[Page 125-126]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.110 Amyloglucosidase derived from Rhizopus niveus.

Amyloglucosidase enzyme product, consisting of enzyme derived from
Rhizopus niveus, and diatomaceous silica as a carrier, may be safely
used in

[[Page 126]]

food in accordance with the following conditions:
(a) Rhizopus niveus is classified as follows: Class, Phycomycetes;
order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, niveus.
(b) The strain of Rhizopus niveus is nonpathogenic and nontoxic in
man or other animals.
(c) The enzyme is produced by a process which completely removes the
organism Rhizopus niveus from the amyloglucosidase.
(d) The additive is used or intended for use for degrading
gelatinized starch into constituent sugars, in the production of
distilled spirits and vinegar.
(e) The additive is used at a level not to exceed 0.1 percent by
weight of the gelatinized starch.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.115]

[Page 126]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.115 Alpha-acetolactate decarboxylase ([alpha]-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis.

The food additive alpha-acetolactate decarboxylase ([alpha]-ALDC)
enzyme preparation, may be safely used in accordance with the following
conditions:
(a) The food additive is the enzyme preparation derived from a
modified Bacillus subtilis strain that contains the gene coding for
[alpha]-ALDC from Bacillus brevis.
(b)(1) The manufacturer produces the additive from a pure culture
fermentation of a strain of Bacillus subtilis that is nonpathogenic and
nontoxigenic in man or other animals.
(2) The manufacturer may stabilize the enzyme preparation with
glutaraldehyde or with other suitable approved food additives or
generally recognized as safe substances.
(3) The enzyme preparation must meet the general and additional
requirements for enzyme preparations in the Food Chemicals Codex, 4th
ed., 1996, pp. 133-134, which is incorporated by reference. The Director
of the Office of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20055, or may be examined at the Center for Food
Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD
20740, or at the Office of the Federal Register, 800 North Capitol St.
NW., suite 700, Washington, DC.
(c) The additive is used in an amount not in excess of the minimum
required to produce its intended effect as a processing aid in the
production of alcoholic malt beverages and distilled liquors.

[66 FR 27022, May 16, 2001]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.120]

[Page 126]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.120 Carbohydrase and cellulase derived from Aspergillus niger.

Carbohydrase and cellulase enzyme preparation derived from
Aspergillus niger may be safely used in food in accordance with the
following prescribed conditions:
(a) Aspergillus niger is classified as follows: Class,
Deuteromycetes; order, Moniliales; family, Moniliaceae; genus,
Aspergillus; species, niger.
(b) The strain of Aspergillus niger is nonpathogenic and nontoxic in
man or other animals.
(c) The additive is produced by a process that completely removes
the organism Aspergillus niger from the carbohydrase and cellulase
enzyme product.
(d) The additive is used or intended for use as follows:
(1) For removal of visceral mass (bellies) in clam processing.
(2) As an aid in the removal of the shell from the edible tissue in
shrimp processing.
(e) The additive is used in an amount not in excess of the minimum
required to produce its intended effect.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.130]

[Page 126-127]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.130 Carbohydrase derived from Rhizopus oryzae.

Carbohydrase from Rhizopus oryzae may be safely used in the
production of dextrose from starch in accordance with the following
prescribed conditions:
(a) Rhizopus oryzae is classified as follows: Class, Phycomycetes;
order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, Rhizopus
oryzae.
(b) The strain of Rhizopus oryzae is nonpathogenic and nontoxic.
(c) The carbohydrase is produced under controlled conditions to
maintain nonpathogenicity and nontoxicity, including the absence of
aflatoxin.

[[Page 127]]

(d) The carbohydrase is produced by a process which completely
removes the organism Rhizopus oryzae from the carbohydrase product.
(e) The carbohydrase is maintained under refrigeration from
production to use and is labeled to include the necessity of
refrigerated storage.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.135]

[Page 127]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.135 Catalase derived from Micrococcus lysodeikticus.

Bacterial catalase derived from Micrococcus lysodeikticus by a pure
culture fermentation process may be safely used in destroying and
removing hydrogen peroxide used in the manufacture of cheese, in
accordance with the following conditions.
(a) The organism Micrococcus lysodeikticus from which the bacterial
catalase is to be derived is demonstrated to be nontoxic and
nonpathogenic.
(b) The organism Micrococcus lysodeikticus is removed from the
bacterial catalase prior to use of the bacterial catalase.
(c) The bacterial catalase is used in an amount not in excess of the
minimum required to produce its intended effect.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.140]

[Page 127]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.140 Esterase-lipase derived from Mucor miehei.

Esterase-lipase enzyme, consisting of enzyme derived from Mucor
miehei var. Cooney et Emerson by a pure culture fermentation process,
with maltodextrin or sweet whey as a carrier, may be safely used in food
in accordance with the following conditions:
(a) Mucor miehei var. Cooney et Emerson is classified as follows:
Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family,
Mucoraceae; genus, Mucor; species, miehei; variety Cooney et Emerson.
(b) The strain of Mucor miehei var. Cooney et Emerson is
nonpathogenic and nontoxic in man or other animals.
(c) The enzyme is produced by a process which completely removes the
organism Mucor miehei var. Cooney et Emerson from the esterase-lipase.
(d) The enzyme is used as a flavor enhancer as defined in
Sec. 170.3(o)(12).
(e) The enzyme is used at levels not to exceed current good
manufacturing practice in the following food categories: cheeses as
defined in Sec. 170.3(n)(5) of this chapter; fat and oils as defined in
Sec. 170.(3)(n)(12) of this chapter; and milk products as defined in
Sec. 170.(3)(n)(31) of this chapter. Use of this food ingredient is
limited to nonstandarized foods and those foods for which the relevant
standards of identity permit such use.
(f) The enzyme is used in the minimum amount required to produce its
limited technical effect.

[47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, 1983]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.145]

[Page 127]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.145 Alpha-Galactosidase derived from Mortierella vinaceae var. raffinoseutilizer.

The food additive alpha-galactosidase and parent mycelial
microorganism Mortierella vinaceae var. raffinoseutilizer may be safely
used in food in accordance with the following conditions:
(a) The food additive is the enzyme alpha-galactosidase and the
mycelia of the microorganism Mortierella vinaceae var. raffinoseutilizer
which produces the enzyme.
(b) The nonpathogenic microorganism matches American Type Culture
Collection (ATCC) No. 20034, \1\ and is classified as follows:
---------------------------------------------------------------------------

\1\ Available from: American Type Culture Collection, 12301 Parklawn
Drive, Rockville, MD 20852.

Class: Phycomycetes.
Order: Mucorales.
Family: Mortierellaceae.
Genus: Mortierella.
Species: vinaceae.
Variety: raffinoseutilizer.

(c) The additive is used or intended for use in the production of
sugar (sucrose) from sugar beets by addition as mycelial pellets to the
molasses to increase the yield of sucrose, followed by removal of the
spent mycelial pellets by filtration.
(d) The enzyme removal is such that there are no enzyme or mycelial
residues remaining in the finished sucrose.

[42 FR 14526, Mar. 15, 1977, as amended at 54 FR 24897, June 12, 1989]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.150]

[Page 127-128]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.150 Milk-clotting enzymes, microbial.

Milk-clotting enzyme produced by pure-culture fermentation process
may

[[Page 128]]

be safely used in the production of cheese in accordance with the
following prescribed conditions:
(a) Milk-clotting enzyme is derived from one of the following
organisms by a pure-culture fermentation process:
(1) Endothia parasitica classified as follows: Class, Ascomycetes;
order, Sphaeriales; family, Diaporthacesae; genus, Endothia; species,
parasitica.
(2) Bacillus cereus classified as follows: Class, Schizomycetes;
order, Eubacteriales; family, Bacillaceae; genus, Bacillus; species,
cereus (Frankland and Frankland).
(3) Mucor pusillus Lindt classified as follows: Class, Phycomycetes;
subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus,
Mucor; species, pusillus; variety, Lindt.
(4) Mucor miehei Cooney et Emerson classified as follows: Class,
Phycomycetes; subclass, Zygomycetes; order, Mucorales; family,
Mucoraceae; genus, Mucor; species, miehei; variety, Cooney et Emerson.
(5) Aspergillus oryzae modified by recombinant deoxyribonucleic
(DNA) techniques to contain the gene coding for aspartic proteinase from
Rhizomucor miehei var. Cooney et Emerson as defined in paragraph (a)(4)
of this section, and classified as follows: Class, Blastodeuteromycetes
(Hyphomycetes); order, Phialidales (Moniliales); genus, Aspergillus;
species oryzae.
(b) The strains of organism identified in paragraph (a) of this
section are nonpathogenic and nontoxic in man or other animals.
(c) The additive is produced by a process that completely removes
the generating organism from the milk-clotting enzyme product.
(d) The additive is used in an amount not in excess of the minimum
required to produce its intended effect in the production of those
cheeses for which it is permitted by standards of identity established
pursuant to section 401 of the Act.

[42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at
62 FR 59284, Nov. 3, 1997]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.160]

[Page 128-129]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.160 Candida guilliermondii.

The food additive Candida guilliermondii may be safely used as the
organism for fermentation production of citric acid in accordance with
the following conditions:
(a) The food additive is the enzyme system of the viable organism
Candida guilliermondii and its concomitant metabolites produced during
the fermentation process.
(b)(1) The nonpathogenic and nontoxicogenic organism descending from
strain, American Type Culture Collection (ATCC) No. 20474,\1\ is
classified as follows:
---------------------------------------------------------------------------

\1\ Available from: American Type Culture Collection, 12301 Parklawn
Drive, Rockville, MD 20852.

Class: Deuteromycetes.
Order: Moniliales.
Family: Cryptococcaceae.
Genus: Candida.
Species: guilliermondii.
Variety: guilliermondii.

(2) The toxonomic characteristics of the reference culture strain
ATCC No. 20474 agree in the essentials with the standard description for
Candida guilliermondii variety guilliermondii listed in "The Yeasts--A
Toxonomic Study;" 2d Ed. (1970), by Jacomina Lodder, which is
incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(c)(1) The additive is used or intended for use as a pure culture in
the fermentation process for the production of citric acid using an
acceptable aqueous carbohydrate substrate.
(2) The organism Candida quilliermondii is made nonviable and is
completely removed from the citric acid during the recovery and
purification process.
(d) The additive is so used that the citric acid produced conforms
to the specifications of the "Food Chemicals Codex," 3d Ed. (1981),
under "Citric acid," pp. 86-87, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register., 800

[[Page 129]]

North Capitol Street, NW., suite 700, Washington, DC 20408.

[42 FR 14526, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982;
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.165]

[Page 129-131]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.165 Candida lipolytica.

The food additive Candida lipolytica may be safely used as the
organism for fermentation production of citric acid in accordance with
the following conditions:
(a) The food additive is the enzyme system of the organism Candida
lipolytica and its concimitant metabolites produced during the
fermentation process.
(b)(1) The nonpathogenic organism is classified as follows:

Class: Deuteromycetes.
Order: Moniliales.
Family: Cryptococcaceae.
Genus: Candida.
Species: lipolytica.

(2) The taxonomic characteristics of the culture agree in essential
with the standard description for Candida lipolytica variety lipolytica
listed in "The Yeasts--A Toxonomic Study," 2d Ed. (1970), by Jacomina
Lodder, which is incorporated by reference. Copies are available from
the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(c) The additive is used or intended for use as a pure culture in
the fermentation process for the production of citric acid from purified
normal alkanes.
(d) The additive is so used that the citric acid produced conforms
to the specifications of the "Food Chemicals Codex," 3d Ed. (1981),
pp. 86-87, which is incorporated by reference. Copies may be obtained
from the National Academy Press, 2101 Constitution Ave. NW., Washington,
DC 20418, or may be examined at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Wasington, DC 20408. The additive
meets the following ultraviolet absorbance limits when subjected to the
analytical procedure described in this paragraph:

------------------------------------------------------------------------
Ultraviolet absorbance per centimeter path length Maximum
------------------------------------------------------------------------
280 to 289 millimicrons..................................... 0.25
290 to 299 millimicrons..................................... 0.20
300 to 359 millimicrons..................................... 0.13
360 to 400 millimicrons..................................... 0.03
------------------------------------------------------------------------

Analytical Procedure for Citric Acid

general instructions

Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent residues, etc. Examine all glassware
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of citric acid samples in handling is
essential to assure absence of any extraneous material arising from
inadequate packaging. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.

apparatus

1. Aluminum foil, oil free.
2. Separatory funnels, 500-milliliter capacity, equipped with
tetrafluoroethylene polymer stopcocks.
3. Chromatographic tubes: (a) 80-millimeter ID x 900-millimeter
length equipped with tetrafluoroethylene polymer stopcock and course
fritted disk; (b) 18-millimeter ID x 300-millimeter length equipped with
tetrafluoroethylene polymer stopcock.
4. Rotary vacuum evaporator, Buchi or equivalent.
5. Spectrophotometer--Spectral range 250-400 nanometers with
spectral slit width of 2 nanometers or less; under instrument operating
conditions for these absorbance measurements, the spectrophotometer
shall also meet the following performance requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Wavelength repeatability, 0.2 nanometer.
Wavelength accuracy, 1.0 nanometer.
The spectrophotometer is equipped with matched 1 centimeter path
length quartz microcuvettes with 0.5-milliliter volume capacity.
6. Vacuum oven, minimum inside dimensions: 200 mm x 200 mm x 300 mm
deep.

[[Page 130]]

reagents and materials

Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
methyl alcohol, isooctane, benzene, hexane and 1,2-dichloroethane
designated in the list following this paragraph shall pass the following
test:
The specified quantity of solvent is added to a 250-milliliter round
bottom flask containing 0.5 milliliter of purified n-hexadecane and
evaporated on the rotary evaporator at 45 deg.C to constant volume. Six
milliliters of purified isooctane are added to this residue and
evaporated under the same conditions as above for 5 minutes. Determine
the absorbance of the residue compared to purified n-hexadecane as
reference. The absorbance of the solution of the solvent residue shall
not exceed 0.03 per centimeter path length between 280 and 299
nanometers and 0.01 per centimeter path length between 300 and 400
nanometers.
Methyl alcohol, A.C.S. reagent grade. Use 100 milliliters for the
test described in the preceding paragraph. If necessary, methyl alcohol
may be purified by distillation through a Virgreaux column discarding
the first and last ten percent of the distillate or otherwise.
Benzene, spectrograde (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 80 milliliters for the test. If
necessary, benzene may be purified by distillation or otherwise.
Isooctane (2,2,4-trimethylpentane). Use 100 milliliters for the
test. If necessary, isooctane may be purified by passage through a
column of activated silica gel, distillation or otherwise.
Hexane, spectrograde (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 100 milliliters for the test. If
necessary, hexane may be purified by distillation or otherwise.
1,2-Dichloroethane, spectrograde (Matheson, Coleman and Bell, East
Rutherford, N.J., or equivalent). Use 100 milliliters for the test. If
necessary, 1,2-dichloroethane may be purified by distillation or
otherwise.

eluting mixtures

1. 10 percent 1,2-dichloroethane in hexane. Prepare by mixing the
purified solvents in the volume ratio of 1 part of 1,2-dichloroethane to
9 parts of hexane.
2. 40 percent benzene in hexane. Prepare by mixing the purified
solvents in the volume ratio of 4 parts of benzene to 6 parts of hexane.
n-Hexadecane, 99 percent olefin-free. Determine the absorbance
compared to isooctane as reference. The absorbance per centimeter path
length shall not exceed 0.00 in the range of 280-400 nanometers. If
necessary, n-hexadecane may be purified by percolation through activated
silica gel, distillation or otherwise.
Silica gel, 28-200 mesh (Grade 12, Davison Chemical Co., Baltimore,
MD, or equivalent). Activate as follows: Slurry 900 grams of silica gel
reagent with 2 liters of purified water in a 3-liter beaker. Cool the
mixture and pour into a 80 x 900 chromatographic column with coarse
fritted disc. Drain the water, wash with an additional 6 liters of
purified water and wash with 3,600 milliliters of purified methyl
alcohol at a relatively slow rate. Drain all of the solvents and
transfer the silica gel to an aluminum foil-lined drying dish. Place
foil over the top of the dish. Activate in a vacuum oven at low vacuum
(approximately 750 millimeters Mercury or 27 inches of Mercury below
atmospheric pressure) at 173 deg. to 177 deg.C for at least 20 hours.
Cool under vacuum and store in an amber bottle.
Sodium sulfate, anhydrous, A.C.S. reagent grade. This reagent should
be washed with purified isooctane. Check the purity of this reagent as
described in Sec. 172.886 of this chapter.
Water, purified. All water used must meet the specifications of the
following test:
Extract 600 milliliters of water with 50 milliliters of purified
isooctane. Add 1 milliliter of purified n-hexadecane to the isooctane
extract and evaporate the resulting solution to 1 milliliter. The
absorbance of this residue shall not exceed 0.02 per centimeter path
length between 300-400 nanometers and 0.03 per centimeter path length
between 280-299 nanometers. If necessary, water may be purified by
distillation, extraction with purified organic solvents, treatment with
an absorbent (e.g., activated carbon) followed by filtration of the
absorbent or otherwise.

procedure

Separate portions of 200 milliliters of purified water are taken
through the procedure for use as control blanks. Each citric acid sample
is processed as follows: Weigh 200 grams of anhydrous citric acid into a
500 milliliter flask and dissolve in 200 milliliters of pure water. Heat
the solution to 60 deg.C and transfer to a 500 milliliter separatory
funnel. Rinse the flask with 50 milliliters of isooctane and add the
isooctane to the separatory funnel. Gently shake the mixture 90 times
(caution: vigorous shaking will cause emulsions) with periodic release
of the pressure caused by shaking.
Allow the phases to separate for at least 5 minutes. Draw off the
lower aqueous layer into a second 500-milliliter separatory funnel and
repeat the extraction with a second aliquot of 50 milliliters of
isooctane. After separation of the layers, draw off and discard the
water layer. Combine both isooctane extracts in the funnel containing
the first extract. Rinse the funnel which contained the

[[Page 131]]

second extract with 10 milliliters of isooctane and add this portion to
the combined isooctane extract.
A chromatographic column containing 5.5 grams of silica gel and 3
grams of anhydrous sodium sulfate is prepared for each citric acid
sample as follows: Fit 18 x 300 column with a small glass wool plug.
Rinse the inside of the column with 10 milliliters of purified
isooctane. Drain the isooctane from the column. Pour 5.5 grams of
activated silica gel into the column. Tap the column approximately 20
times on a semisoft, clean surface to settle the silica gel. Carefully
pour 3 grams of anhydrous sodium sulfate onto the top of the silica gel
in the column.
Carefully drain the isooctane extract of the citric acid solution
into the column in a series of additions while the isooctane is draining
from the column at an elution rate of approximately 3 milliliters per
minute. Rinse the separatory funnel with 10 milliliters of isooctane
after the last portion of the extract has been applied to the column and
add this rinse to the column. After all of the extract has been applied
to the column and the solvent layer reaches the top of the sulfate bed,
rinse the column with 25 milliliters of isooctane followed by 10
milliliters of a 10-percent dichloroethane in hexane solution. For each
rinse solution, drain the column until the solvent layer reaches the top
of the sodium sulfate bed. Discard the rinse solvents. Place a 250-
milliliter round bottom flask containing 0.5 milliliter of purified n-
hexadecane under the column. Elute the polynuclear aromatic hydrocarbons
from the column with 30 milliliters of 40-percent benzene in hexane
solution. Drain the eluate until the 40-percent benzene in the hexane
solvent reaches the top of the sodium sulfate bed.
Evaporate the 40-percent benzene in hexane eluate on the rotary
vacuum evaporator at 45 deg.C until only the n-hexadecane residue of
0.5 milliliter remains. Treat the n-hexadecane residue twice with the
following wash step: Add 6 milliliters of purified isooctane and remove
the solvents by vacuum evaporation at 45 deg.C to constant volume,
i.e., 0.5 milliliter. Cool the n-hexadecane residue and transfer the
solution to an 0.5-milliliter microcuvette. Determine the absorbance of
this solution compared to purified n-hexadecane as reference. Correct
the absorbance values for any absorbance derived from the control
reagent blank. If the corrected absorbance does not exceed the limits
prescribed, the samples meet the ultraviolet absorbance specifications.
The reagent blank is prepared by using 200 milliliters of purified
water in place of the citric acid solution and carrying the water sample
through the procedure. The typical control reagent blank should not
exceed 0.03 absorbance per centimeter path length between 280 and 299
nanometers, 0.02 absorbance per centimeter path length between 300 and
359 nanometers, and 0.01 absorbance per centimeter path length between
360 and 400 nanometers.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982;
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.170]

[Page 131]

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 B--Enzyme Preparations and Microorganisms

Sec. 173.170 Aminoglycoside 3'-phosphotransferase II.

The food additive aminoglycoside 3'-phosphotransferase II may be
safely used in the development of genetically modified cotton, oilseed
rape, and tomatoes in accordance with the following prescribed
conditions:
(a) The food additive is the enzyme aminoglycoside 3'-
phosphotransferase II (CAS Reg. No. 58943-39-8) which catalyzes the
phosphorylation of certain aminoglycoside antibiotics, including
kanamycin, neomycin, and gentamicin.
(b) Aminoglycoside 3'-phosphotransferase II is encoded by the
kanr gene originally isolated from transposon Tn5
of the bacterium Escherichia coli.
(c) The level of the additive does not exceed the amount reasonably
required for selection of plant cells carrying the kanr gene
along with the genetic material of interest.

[59 FR 26711, May 23, 1994]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.210]

[Page 131]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.210 Acetone.

A tolerance of 30 parts per million is established for acetone in
spice oleoresins when present therein as a residue from the extraction
of spice.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.220]

[Page 131-132]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.220 1,3-Butylene glycol.

1,3-Butylene glycol (1,3-butanediol) may be safely used in food in
accordance with the following prescribed conditions:
(a) The substance meets the following specifications:
(1) 1,3-Butylene glycol content: Not less than 99 percent.
(2) Specific gravity at 20/20 deg.C: 1.004 to 1.006.
(3) Distillation range: 200 deg.-215 deg.C.
(b) It is used in the minimum amount required to perform its
intended effect.

[[Page 132]]

(c) It is used as a solvent for natural and synthetic flavoring
substances except where standards of identity issued under section 401
of the act preclude such use.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.228]

[Page 132]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.228 Ethyl acetate.

Ethyl acetate (CAS Reg. No. 141-78-6) may be safely used in food in
accordance with the following conditions:
(a) The additive meets the specifications of the Food Chemicals
Codex, \1\ (Ethyl Acetate; p. 372, 3d Ed., 1981), which are incorporated
by reference.
---------------------------------------------------------------------------

\1\ Copies may be obtained from: National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418 or examined at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
---------------------------------------------------------------------------

(b) The additive is used in accordance with current good
manufacturing practice as a solvent in the decaffeination of coffee and
tea.

[47 FR 146, Jan. 5, 1982, as amended at 49 FR 28548, July 13, 1984]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.230]

[Page 132]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.230 Ethylene dichloride.

A tolerance of 30 parts per million is established for ethylene
dichloride in spice oleoresins when present therein as a residue from
the extraction of spice; Provided, however, That if residues of other
chlorinated solvents are also present the total of all residues of such
solvents shall not exceed 30 parts per million.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.240]

[Page 132]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.240 Isopropyl alcohol.

Isopropyl alcohol may be present in the following foods under the
conditions specified:
(a) In spice oleoresins as a residue from the extraction of spice,
at a level not to exceed 50 parts per million.
(b) In lemon oil as a residue in production of the oil, at a level
not to exceed 6 parts per million.
(c) In hops extract as a residue from the extraction of hops at a
level not to exceed 2.0 percent by weight: Provided, That,
(1) The hops extract is added to the wort before or during cooking
in the manufacture of beer.
(2) The label of the hops extract specifies the presence of the
isopropyl alcohol and provides for the use of the hops extract only as
prescribed by paragraph (c)(1) of this section.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.250]

[Page 132]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.250 Methyl alcohol residues.

Methyl alcohol may be present in the following foods under the
conditions specified:
(a) In spice oleoresins as a residue from the extraction of spice,
at a level not to exceed 50 parts per million.
(b) In hops extract as a residue from the extraction of hops, at a
level not to exceed 2.2 percent by weight; Provided, That:
(1) The hops extract is added to the wort before or during cooking
in the manufacture of beer.
(2) The label of the hops extract specifies the presence of methyl
alcohol and provides for the use of the hops extract only as prescribed
by paragraph (b)(1) of this section.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.255]

[Page 132]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.255 Methylene chloride.

Methylene chloride may be present in food under the following
conditions:
(a) In spice oleoresins as a residue from the extraction of spice,
at a level not to exceed 30 parts per million; Provided, That, if
residues of other chlorinated solvents are also present, the total of
all residues of such solvents shall not exceed 30 parts per million.
(b) In hops extract as a residue from the extraction of hops, at a
level not to exceed 2.2 percent, Provided, That:
(1) The hops extract is added to the wort before or during cooking
in the manufacture of beer.
(2) The label of the hops extract identifies the presence of the
methylene chloride and provides for the use of the hops extract only as
prescribed by paragraph (b)(1) of this section.
(c) In coffee as a residue from its use as a solvent in the
extraction of caffeine from green coffee beans, at a level not to exceed
10 parts per million (0.001 percent) in decaffeinated roasted coffee and
in decaffeinated soluble coffee extract (instant coffee).

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.270]

[Page 132-133]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.270 Hexane.

Hexane may be present in the following foods under the conditions
specified:

[[Page 133]]

(a) In spice oleoresins as a residue from the extraction of spice,
at a level not to exceed 25 parts per million.
(b) In hops extract as a residue from the extraction of hops, at a
level not to exceed 2.2 percent by weight; Provided, That:
(1) The hops extract is added to the wort before or during cooking
in the manufacture of beer.
(2) The label of the hops extract specifies the presence of the
hexane and provides for the use of the hops extract only as prescribed
by paragraph (b)(1) of this section.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.275]

[Page 133]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.275 Hydrogenated sperm oil.

The food additive hydrogenated sperm oil may be safely used in
accordance with the following prescribed conditions:
(a) The sperm oil is derived from rendering the fatty tissue of the
sperm whale or is prepared by synthesis of fatty acids and fatty
alcohols derived from the sperm whale. The sperm oil obtained by
rendering is refined. The oil is hydrogenated.
(b) It is used alone or as a component of a release agent or
lubricant in bakery pans.
(c) The amount used does not exceed that reasonably required to
accomplish the intended lubricating effect.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.280]

[Page 133]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.280 Solvent extraction process for citric acid.

A solvent extraction process for recovery of citric acid from
conventional Aspergillus niger fermentation liquor may be safely used to
produce food-grade citric acid in accordance with the following
conditions:
(a) The solvent used in the process consists of a mixture of n-octyl
alcohol meeting the requirements of Sec. 172.864 of this chapter,
synthetic isoparaffinic petroleum hydrocarbons meeting the requirements
of Sec. 172.882 of this chapter, and tridodecyl amine.
(b) The component substances are used solely as a solvent mixture
and in a manner that does not result in formation of products not
present in conventionally produced citric acid.
(c) The citric acid so produced meets the specifications of the
"Food Chemicals Codex," 3d Ed. (1981), pp. 86-87, which is
incorporated by reference (copies may be obtained from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may
be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408), and the polynuclear
aromatic hydrocarbon specifications of Sec. 173.165.
(d) Residues of n-octyl alcohol and synthetic isoparaffinic
petroleum hydrocarbons are removed in accordance with good manufacturing
practice. Current good manufacturing practice results in residues not
exceeding 16 parts per million (ppm) n-octyl alcohol and 0.47 ppm
synthetic isoparaffinic petroleum hydrocarbons in citric acid.
(e) Tridodecyl amine may be present as a residue in citric acid at a
level not to exceed 100 parts per billion.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10106, Mar. 19, 1984]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.290]

[Page 133]

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 C--Solvents, Lubricants, Release Agents and Related Substances

Sec. 173.290 Trichloroethylene.

Tolerances are established for residues of trichloroethylene
resulting from its use as a solvent in the manufacture of foods as
follows:

Decaffeinated ground coffee............... 25 parts per million.
Decaffeinated soluble (instant) coffee 10 parts per million.
extract.
Spice oleoresins.......................... 30 parts per million
(provided that if residues
of other chlorinated
solvents are also present,
the total of all residues
of such solvents in spice
oleoresins shall not exceed
30 parts per million).

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.300]

[Page 133-134]

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. 173.300 Chlorine dioxide.

Chlorine dioxide (CAS Reg. No. 10049-04-4) may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive is generated by one of the following methods:
Treating an aqueous solution of sodium chlorite with either chlorine gas
or a mixture of sodium hypochlorite and hydrochloric acid, or treating
an aqueous solution of sodium chlorate with hydrogen peroxide in the
presence of sulfuric acid. In either case, the generator effluent
contains at least 90 percent (by weight)

[[Page 134]]

of chlorine dioxide with respect to all chlorine species as determined
by Method 4500-ClO2 E in the "Standard Methods for the
Examination of Water and Wastewater," 18th ed., 1992, or an equivalent
method. Method 4500-ClO2 E is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, and the American Public Health Association, 1015 Fifteenth St.
NW., Washington, DC 20005, or may be examined at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(b)(1) The additive may be used as an antimicrobial agent in water
used in poultry processing in an amount not to exceed 3 parts per
million (ppm) residual chlorine dioxide as determined by Method 4500-
ClO2 E, referenced in paragraph (a) of this section, or an
equivalent method.
(2) The additive may be used as an antimicrobial agent in water used
to wash fruits and vegetables that are not raw agricultural commodities
in an amount not to exceed 3 ppm residual chlorine dioxide as determined
by Method 4500-ClO2 E, referenced in paragraph (a) of this
section, or an equivalent method. Treatment of the fruits and vegetables
with chlorine dioxide shall be followed by a potable water rinse or by
blanching, cooking, or canning.

[60 FR 11900, Mar. 3, 1995. Redesignated at 61 FR 14245, Apr. 1, 1996,
as amended at 61 FR 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; 65
FR 34587, May 31, 2000]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.310]

[Page 134-136]

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. 173.310 Boiler water additives.

Boiler water additives may be safely used in the preparation of
steam that will contact food, under the following conditions:
(a) The amount of additive is not in excess of that required for its
functional purpose, and the amount of steam in contact with food does
not exceed that required to produce the intended effect in or on the
food.
(b) The compounds are prepared from substances identified in
paragraphs (c) and (d) of this section, and are subject to the
limitations, if any, prescribed:
(c) List of substances:

------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Acrylamide-sodium acrylate resin... Contains not more than 0.05 percent
by weight of acrylamide monomer.
Acrylic acid/2-acrylamido-2-methyl Total not to exceed 20 parts per
propane sulfonic acid copolymer million (active) in boiler
having a minimum weight average feedwater.
molecular weight of 9,900 and a
minimum number average molecular
weight of 5,700 as determined by a
method entitled "Determination of
Weight Average and Number Average
Molecular Weight of 60/40 AA/
AMPS" (October 23, 1987), which
is incorporated by reference in
accordance with 5 U.S.C. 552(a).
Copies may be obtained from the
Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or
may be examined at the Office of
the Federal Register, 800 North
Capitol Street, NW., suite 700,
Washington, DC.
Ammonium alginate..................
Cobalt sulfate (as catalyst).......
1-hydroxyethylidene-1,1-
diphosphonic acid (CAS Reg. No.
2809-21-4) and its sodium and
potassium salts.
Lignosulfonic acid.................
Monobutyl ethers of polyethylene- Minimum mol. wt. 1,500.
polypropylene glycol produced by
random condensation of a 1:1
mixture by weight of ethylene
oxide and propylene oxide with
butanol.
Poly(acrylic acid-co- Total not to exceed 1.5 parts per
hypophosphite), sodium salt (CAS million in boiler feed water.
Reg. No. 71050-62-9), produced Copolymer contains not more than
from a 4:1 to a 16:1 mixture by 0.5 percent by weight of acrylic
weight of acrylic acid and sodium acid monomer (dry weight basis).
hypophosphite.
Polyethylene glycol................ As defined in Sec. 172.820 of this
chapter.
Polymaleic acid [CAS Reg. No. 26099- Total not to exceed 1 part per
09-2], and/or its sodium salt. million in boiler feed water
[CAS Reg. No. 30915-61-8 or CAS (calculated as the acid).
Reg. No. 70247-90-4].
Polyoxypropylene glycol............ Minimum mol. wt. 1,000.
Potassium carbonate................
Potassium tripolyphosphate.........
Sodium acetate.....................
Sodium alginate....................

[[Page 135]]

Sodium aluminate...................
Sodium carbonate...................
Sodium carboxymethylcellulose...... Contains not less than 95 percent
sodium carboxymethylcellulose on a
dry-weight basis, with maximum
substitution of 0.9
carboxymethylcellulose groups per
anhydroglucose unit, and with a
minimum viscosity of 15
centipoises for 2 percent by
weight aqueous solution at 25
deg.C; by the method prescribed in
the "Food Chemicals Codex," 4th
ed. (1996), pp. 744-745, which is
incorporated by reference in
accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are
available from the National
Academy Press, Box 285, 2101
Constitution Ave. NW., Washington,
DC 20055 (Internet address "http:/
/www.nap.edu"), or may be
examined at the Center for Food
Safety and Applied Nutrition's
Library, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or
at the Office of the Federal
Register, 800 North Capitol St.
NW., suite 700, Washington, DC.
Sodium glucoheptonate.............. Less than 1 part per million
cyanide in the sodium
glucoheptonate.
Sodium hexametaphosphate...........
Sodium humate......................
Sodium hydroxide...................
Sodium lignosulfonate..............
Sodium metabisulfite...............
Sodium metasilicate................
Sodium nitrate.....................
Sodium phosphate (mono-, di-, tri-)
Sodium polyacrylate................
Sodium polymethacrylate............
Sodium silicate....................
Sodium sulfate.....................
Sodium sulfite (neutral or
alkaline).
Sodium tripolyphosphate............
Sorbitol anhydride esters: a The mixture is used as an
mixture consisting of sorbitan anticorrosive agent in steam
monostearate as defined in Sec. boiler distribution systems, with
172.842 of this chapter; each component not to exceed 15
polysorbate 60 ((polyoxyethylene parts per million in the steam.
(20) sorbitan monostearate)) as
defined in Sec. 172.836 of this
chapter; and polysorbate 20
((polyoxyethylene (20) sorbitan
monolaurate)), meeting the
specifications of the Food
Chemicals Codex, 4th ed. (1996),
pp. 306-307, which is incorporated
by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the
National Academy Press, 2101
Constitution Ave. NW., Box 285,
Washington, DC 20055 (Internet
http://www.nap.edu), or may be
examined at the Center for Food
Safety and Applied Nutrition's
Library, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or
at the Office of the Federal
Register, 800 North Capitol St.
NW., suite 700, Washington, DC.
Tannin (including quebracho
extract).
Tetrasodium EDTA...................
Tetrasodium pyrophosphate..........
------------------------------------------------------------------------

(d) Substances used alone or in combination with substances in
paragraph (c) of this section:

------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Cyclohexylamine......................... Not to exceed 10 parts per
million in steam, and
excluding use of such steam
in contact with milk and milk
products.
Diethylaminoethanol..................... Not to exceed 15 parts per
million in steam, and
excluding use of such steam
in contact with milk and milk
products.
Hydrazine............................... Zero in steam.
Morpholine.............................. Not to exceed 10 parts per
million in steam, and
excluding use of such steam
in contact with milk and milk
products.
Octadecylamine.......................... Not to exceed 3 parts per
million in steam, and
excluding use of such steam
in contact with milk and milk
products.
Trisodium nitrilotriacetate............. Not to exceed 5 parts per
million in boiler feedwater;
not to be used where steam
will be in contact with milk
and milk products.
------------------------------------------------------------------------

[[Page 136]]

(e) To assure safe use of the additive, in addition to the other
information required by the Act, the label or labeling shall bear:
(1) The common or chemical name or names of the additive or
additives.
(2) Adequate directions for use to assure compliance with all the
provisions of this section.

[42 FR 14526, Mar. 15, 1977, as amended at 45 FR 73922, Nov. 7, 1980; 45
FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. 15,
1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 53 FR
15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2,
1990; 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, 1999; 64 FR 29227,
June 1, 1999]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.315]

[Page 136-137]

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. 173.315 Chemicals used in washing or to assist in the peeling of fruits and vegetables.

Chemicals may be safely used to wash or to assist in the peeling of
fruits and vegetables in accordance with the following conditions:
(a) The chemicals consist of one or more of the following:
(1) Substances generally recognized as safe in food or covered by
prior sanctions for use in washing fruits and vegetables.
(2) Substances identified in this subparagraph and subject to such
limitations as are provided:

------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
A mixture of alkylene oxide adducts of May be used at a level not to
alkyl alcohols and phosphate esters of exceed 0.2 percent in lye-
alkylene oxide adducts of alkyl peeling solution to assist in
alcohols consisting of: [alpha]-alkyl the lye peeling of fruit and
(C12-C18)-omega-hydroxy-poly vegetables.
(oxyethylene) (7.5-8.5 moles)/poly
(oxypropylene) block copolymer having
an average molecular weight of 810;
[alpha]-alkyl (C12-C18)-omega-hydroxy-
poly (oxyethylene) (3.3-3.7 moles)
polymer having an average molecular
weight of 380, and subsequently
esterified with 1.25 moles phosphoric
anhydride; and [alpha]-alkyl (C10-C12)-
omega-hydroxypoly (oxyethylene) (11.9-
12.9 moles)/poly (oxypropylene)
copolymer, having an average molecular
weight of 810, and subsequently
esterified with 1.25 moles phosphoric
anhydride.
Aliphatic acid mixture consisting of May be used at a level not to
valeric, caproic, enanthic, caprylic, exceed 1 percent in lye
and pelargonic acids. peeling solution to assist in
the lye peeling of fruits and
vegetables.
Polyacrylamide......................... Not to exceed 10 parts per
million in wash water.
Contains not more than 0.2
percent acrylamide monomer.
May be used in the washing of
fruits and vegetables.
Potassium bromide...................... May be used in the washing or
to assist in the lye peeling
of fruits and vegetables.
Sodium n-alkylbenzene-sulfonate (alkyl Not to exceed 0.2 percent in
group predominantly C12 and C13 and wash water. May be used in
not less than 95 percent C10 to C16). washing or to assist in the
lye peeling of fruits and
vegetables.
Sodium dodecylbenzene-sulfonate (alkyl Do.
group predominantly C12 and not less
than 95% C10 to C16).
Sodium 2 ethyl-hexyl sulfate........... Do.
Sodium hypochlorite.................... May be used in the washing or
to assist in the lye peeling
of fruits and vegetables.
Sodium mono- and dimethyl naphthalene Not to exceed 0.2 percent in
sulfonates (mol. wt. 245-260). wash water. May be used in the
washing or to assist in the
lye peeling of fruits and
vegetables.
------------------------------------------------------------------------

(3) Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245-
260) may be used in the steam/scald vacuum peeling of tomatoes at a
level not to exceed 0.2 percent in the condensate or scald water.
(4) Substances identified in this paragraph (a)(4) for use in flume
water for washing sugar beets prior to the slicing operation and subject
to the limitations as are provided for the level of the substances in
the flume water:

------------------------------------------------------------------------
Substance Limitations
------------------------------------------------------------------------
[alpha]-Alkyl-omega-hydroxypoly- Not to exceed 3 ppm.
(oxyethylene) produced by condensation of
1 mole of C11-C486315 straight chain
randomly substituted secondary alcohols
with an average of 9 moles of ethylene
oxide.
Linear undecylbenzenesulfonic acid........ Do.
Dialkanolamide produced by condensing 1 Not to exceed 2 ppm.
mole of methyl laurate with 1.05 moles of
diethanolamine.
Triethanolamine........................... Do.
Ethylene glycol monobutyl ether........... Not to exceed 1 ppm.

[[Page 137]]

Oleic acid conforming with Sec. 172.860 Do.
of this chapter.
Tetrapotassium pyrophosphate.............. Not to exceed 0.3 ppm.
Monoethanolamine.......................... Do.
Ethylene dichloride....................... Not to exceed 0.2 ppm.
Tetrasodium ethylenediaminetetraacetate... Not to exceed 0.1 ppm.
------------------------------------------------------------------------

(5) Substances identified in this paragraph (a)(5) for use on fruits
and vegetables that are not raw agricultural commodities and subject to
the limitations provided:

------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Hydrogen peroxide........................ Used in combination with
acetic acid to form
peroxyacetic acid. Not to
exceed 59 ppm in wash water.
1-Hydroxyethylidene-1,1-diphosphonic acid May be used only with
peroxyacetic acid. Not to
exceed 4.8 ppm in wash
water.
Peroxyacetic acid........................ Prepared by reacting acetic
acid with hydrogen peroxide.
Not to exceed 80 ppm in wash
water.
------------------------------------------------------------------------

(b) The chemicals are used in amounts not in excess of the minimum
required to accomplish their intended effect.
(c) The use of the chemicals listed under paragraphs (a)(1), (a)(2),
and (a)(4) is followed by rinsing with potable water to remove, to the
extent possible, residues of the chemicals.
(d) To assure safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the act, the name of the
additive or a statement of its composition.
(2) The label or labeling of the additive container shall bear
adequate use directions to assure use in compliance with all provisions
of this section.

[42 FR 14526, Mar. 15, 1977, as amended at 42 FR 29856, June 10, 1977;
42 FR 32229, June 24, 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376,
46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; 64 FR 38564, July 19,
1999]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.320]

[Page 137-138]

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. 173.320 Chemicals for controlling microorganisms in cane-sugar and beet-sugar mills.

Agents for controlling microorganisms in cane-sugar and beet-sugar
mills may be safely used in accordance with the following conditions:
(a) They are used in the control of microorganisms in cane-sugar
and/or beet-sugar mills as specified in paragraph (b) of this section.
(b) They are applied to the sugar mill grinding, crusher, and/or
diffuser systems in one of the combinations listed in paragraph (b) (1),
(2), (3), or (5) of this section or as a single agent listed in
paragraph (b) (4) or (6) of this section. Quantities of the individual
additives in parts per million are expressed in terms of the weight of
the raw cane or raw beets.
(1) Combination for cane-sugar mills:

------------------------------------------------------------------------
Parts
per
million
------------------------------------------------------------------------
Disodium cyanodithioimidocarbonate............................. 2.5
Ethylenediamine................................................ 1.0
Potassium N-methyldithiocarbamate.............................. 3.5
------------------------------------------------------------------------

(2) Combination for cane-sugar mills:

(3) Combinations for cane-sugar mills and beet-sugar mills:

------------------------------------------------------------------------
Parts
per
million
------------------------------------------------------------------------
(i) Disodium ethylenebisdithiocarbamate........................ 3.0
Ethylenediamine................................................ 2.0
Sodium dimethyldithiocarbamate................................. 3.0
(ii) Disodium cyanodithioimidocarbonate........................ 2.9
Potassium N-methyldithiocarbamate.............................. 4.1
------------------------------------------------------------------------

(4) Single additive for cane-sugar mills and beet-sugar mills.

------------------------------------------------------------------------
Parts per million
------------------------------------------------------------------------
2,2-Dibromo-3-nitrilopropionamide (CAS Not more than 10.0 and not
Reg. No. 10222-01-2). Limitations: less than 2.0.
Byproduct molasses, bagasse, and pulp
containing residues of 2,2-dibromo-3-
nitrilopropionamide are not authorized
for use in animal feed.
------------------------------------------------------------------------

(5) Combination for cane-sugar mills:

------------------------------------------------------------------------
Parts per
million
------------------------------------------------------------------------
n-Dodecyl dimethyl benzyl ammonium chloride............. 0.05
s0.005
n-Dodecyl dimethyl ethylbenzyl ammonium chloride........ 0.68
s0.068
n-Hexadecyl dimethyl benzyl ammonium chloride........... 0.30
s0.030
n-Octadecyl dimethyl benzyl ammonium chloride........... 0.05
s0.005

[[Page 138]]

n-Tetradecyl dimethyl benzyl ammonium chloride.......... 0.60
s0.060
n-Tetradecyl dimethyl ethylbenzyl ammonium chloride..... 0.32
s0.032
------------------------------------------------------------------------

Limitations. Byproduct molasses, bagasse, and pulp containing residues
of these quaternary ammonium salts are not authorized for use in animal
feed.
(6) Single additive for beet-sugar mills:

------------------------------------------------------------------------
Parts per million
------------------------------------------------------------------------
Glutaraldehyde (CAS Reg. No. 111-30- Not more than 250.
8).
------------------------------------------------------------------------

(c) To assure safe use of the additives, their label and labeling
shall conform to that registered with the Environmental Protection
Agency.

[42 FR 14526, Mar. 15, 1977, as amended at 47 FR 35756, Aug. 17, 1982;
50 FR 3891, Jan. 29, 1985; 57 FR 8065, Mar. 6, 1992]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.322]

[Page 138]

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. 173.322 Chemicals used in delinting cottonseed.

Chemicals may be safely used to assist in the delinting of
cottonseed in accordance with the following conditions:
(a) The chemicals consist of one or more of the following:
(1) Substances generally recognized as safe for direct addition to
food.
(2) Substances identified in this paragraph and subject to such
limitations as are provided:

------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
alpha-Alkyl-omega-hydroxypoly- May be used at an
(oxyethylene) produced by condensation of application rate not to
a linear primary alcohol containing an exceed 0.3 percent by
average chain length of 10 carbons with weight of cottonseeds to
poly(oxyethylene) having an average of 5 enhance delinting of
ethylene oxide units. cottonseeds intended for
the production of
cottonseed oil. Byproducts
including lint, hulls, and
meal may be used in animal
feed.
An alkanomide produced by condensation of May be used at an
coconut oil fatty acids and application rate not to
diethanolamine, CAS Reg. No. 068603-42-9. exceed 0.2 percent by
weight of cottonseeds to
enhance delinting of
cottonseeds intended for
the production of
cottonseed oil. Byproducts
including lint, hulls, and
meal may be used in animal
feed.
------------------------------------------------------------------------

[47 FR 8346, Feb. 26, 1982]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.325]

[Page 138-139]

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. 173.325 Acidified sodium chlorite solutions.

Acidified sodium chlorite solutions may be safely used in accordance
with the following prescribed conditions:
(a) The additive is produced by mixing an aqueous solution of sodium
chlorite (CAS Reg. No. 7758-19-2) with any generally recognized as safe
(GRAS) acid.
(b)(1) The additive is used as an antimicrobial agent in poultry
processing water in accordance with current industry practice under the
following conditions:
(i) As a component of a carcass spray or dip solution prior to
immersion of the intact carcass in a prechiller or chiller tank;
(ii) In a prechiller or chiller solution for application to the
intact carcass;
(iii) As a component of a spray or dip solution for application to
poultry carcass parts;
(iv) In a prechiller or chiller solution for application to poultry
carcass parts; or
(v) As a component of a post-chill carcass spray or dip solution
when applied to poultry meat, organs, or related parts or trim.
(2) When used in a spray or dip solution, the additive is used at
levels that result in sodium chlorite concentrations between 500 and
1,200 parts per million (ppm), in combination with any GRAS acid at a
level sufficient to achieve a solution pH of 2.3 to 2.9.
(3) When used in a prechiller or chiller solution, the additive is
used at levels that result in sodium chlorite concentrations between 50
and 150 ppm, in combination with any GRAS acid at levels sufficient to
achieve a solution pH of 2.8 to 3.2.
(c) The additive is used as an antimicrobial agent in accordance
with current industry practice in the processing of red meat, red meat
parts, and organs as a component of a spray or in the processing of red
meat parts and organs as a component of a dip. Applied as a dip or
spray, the additive is used at levels that result in sodium chlorite
concentrations between 500 and 1,200 ppm in combination with any GRAS
acid at levels sufficient to achieve a solution pH of 2.5 to 2.9.

[[Page 139]]

(d) The additive is used as an antimicrobial agent in water and ice
that are used to rinse, wash, thaw, transport, or store seafood in
accordance with current industry standards of good manufacturing
practice. The additive is produced by mixing an aqueous solution of
sodium chlorite with any GRAS acid to achieve a pH in the range of 2.5
to 2.9 and diluting this solution with water to achieve an actual use
concentration of 40 to 50 parts per million (ppm) sodium chlorite. Any
seafood that is intended to be consumed raw shall be subjected to a
potable water rinse prior to consumption.
(e) The additive is used as an antimicrobial agent on raw
agricultural commodities in the preparing, packing, or holding of the
food for commercial purposes, consistent with section 201(q)(1)(B)(i) of
the act, and not applied for use under section 201(q)(1)(B)(i)(I),
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act, in accordance with
current industry standards of good manufacturing practice. Applied as a
dip or a spray, the additive is used at levels that result in chlorite
concentrations of 500 to 1200 parts per million (ppm), in combination
with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9.
Treatment of the raw agricultural commodities with acidified sodium
chlorite solutions shall be followed by a potable water rinse, or by
blanching, cooking, or canning.
(f) The additive is used as an antimicrobial agent on processed,
comminuted or formed meat food products (unless precluded by standards
of identity in 9 CFR part 319) prior to packaging of the food for
commercial purposes, in accordance with current industry standards of
good manufacturing practice. Applied as a dip or spray, the additive is
used at levels that result in sodium chlorite concentrations of 500 to
1200 ppm, in combination with any GRAS acid at levels sufficient to
achieve a pH of 2.5 to 2.9.
(g) The additive is used as an antimicrobial agent in the water
applied to processed fruits and processed root, tuber, bulb, legume,
fruiting (i.e., eggplant, groundcherry, pepino, pepper, tomatillo, and
tomato), and cucurbit vegetables in accordance with current industry
standards of good manufacturing practices, as a component of a spray or
dip solution, provided that such application be followed by a potable
water rinse and a 24-hour holding period prior to consumption. However,
for processed leafy vegetables (i.e., vegetables other than root, tuber,
bulb, legume, fruiting, and cucurbit vegetables) and vegetables in the
Brassica [Cole] family, application must be by dip treatment only, and
must be preceded by a potable water rinse and followed by a potable
water rinse and a 24-hour holding period prior to consumption. When used
in a spray or dip solution, the additive is used at levels that result
in sodium chlorite concentrations between 500 and 1,200 ppm, in
combination with any GRAS acid at a level sufficient to achieve a
solution pH of 2.3 to 2.9.
(h) The concentration of sodium chlorite is determined by a method
entitled "Determination of Sodium Chlorite: 50 ppm to 1500 ppm
Concentration," September 13, 1995, developed by Alcide Corp., Redmond,
WA, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the Division of
Petition Control (HFS-215), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or may be examined at the Center for Food Safety
and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park,
MD 20740 20204-0001, or the Office of the Federal Register, 800 North
Capitol St. NW., Suite 700, Washington, DC.

[61 FR 17829, Apr. 23, 1996, as amended at 63 FR 11119, Mar. 6, 1998; 64
FR 44123, Aug. 13, 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, Jan.
12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR 22922, May 7, 2001; 66 FR
31841, June 13, 2001; 67 FR 15720, Apr. 3, 2002]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.340]

[Page 139-141]

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.

[[Page 140]]

(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.........................
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) of 10 percent by weight of
this chapter and providing the oleic defoamer formulation.
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 of
acids. 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.

[[Page 141]]

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 Office of
the Federal Register, 800
North Capitol St. NW.,
suite 700, Washington, DC.
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]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.342]

[Page 141]

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. 173.342 Chlorofluorocarbon 113 and perfluorohexane.

A mixture of 99 percent chlorofluorocarbon 113 (1,1,2-trichloro-
1,2,2-trifluoroethane) (CAS Reg. No. 76-13-1, also known as fluorocarbon
113, CFC 113 and FC 113) and 1 percent perfluorohexane (CAS Reg. No.
355-42-0) may be safely used in accordance with the following prescribed
conditions:
(a) The additive chlorofluorocarbon 113 has a purity of not less
than 99.99 percent.
(b) The additive mixture is intended for use to quickly cool or
crust-freeze chickens sealed in intact bags composed of substances
regulated in parts 174, 175, 177, 178, and Sec. 179.45 of this chapter
and conforming to any limitations or specifications in such regulations.

[55 FR 8913, Mar. 9, 1990]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.345]

[Page 141-142]

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. 173.345 Chloropentafluoroethane.

The food additive chloropentafluoroethane may be safely used in food
in accordance with the following prescribed conditions:
(a) The food additive has a purity of not less than 99.97 percent,
and contains not more than 200 parts per million saturated fluoro
compounds and 10 parts per million unsaturated fluoro compounds as
impurities.
(b) The additive is used or intended for use alone or with one or
more of the following substances: Carbon dioxide, nitrous oxide,
propane, and octafluorocyclobutane complying with Sec. 173.360, as an
aerating agent for foamed or sprayed food products, with any propellant
effect being incidental and no more than is minimally necessary to
achieve the aerating function, except that use is not permitted for
those standardized foods that do not provide for such use.
(c) To assure safe use of the additive
(1) The label of the food additive container shall bear, in addition
to the

[[Page 142]]

other information required by the act, the following:
(i) The name of the additive, chloropentafluoroethane.
(ii) The percentage of the additive present in the case of a
mixture.
(iii) The designation "food grade".
(2) The label or labeling of the food additive container shall bear
adequate directions for use.

[42 FR 14526, Mar. 15, 1977, as amended at 43 FR 11317, Mar. 17, 1978;
43 FR 14644, Apr. 7, 1978]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.350]

[Page 142-143]

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. 173.350 Combustion product gas.

The food additive combustion product gas may be safely used in the
processing and packaging of the foods designated in paragraph (c) of
this section for the purpose of removing and displacing oxygen in
accordance with the following prescribed conditions:
(a) The food additive is manufactured by the controlled combustion
in air of butane, propane, or natural gas. The combustion equipment
shall be provided with an absorption-type filter capable of removing
possible toxic impurities, through which all gas used in the treatment
of food shall pass; and with suitable controls to insure that any
combustion products failing to meet the specifications provided in this
section will be prevented from reaching the food being treated.
(b) The food additive meets the following specifications:
(1) Carbon monoxide content not to exceed 4.5 percent by volume.
(2) The ultraviolet absorbance in isooctane solution in the range
255 millimicrons to 310 millimicrons not to exceed one-third of the
standard reference absorbance when tested as described in paragraph (e)
of this section.
(c) It is used or intended for use to displace or remove oxygen in
the processing, storage, or packaging of beverage products and other
food, except fresh meats.
(d) To assure safe use of the additive in addition to the other
information required by the act, the label or labeling of the combustion
device shall bear adequate directions for use to provide a combustion
product gas that complies with the limitations prescribed in paragraph
(b) of this section, including instructions to assure proper filtration.
(e) The food additive is tested for compliance with paragraph (b)(2)
by the following empirical method:

Spectrophotometric measurements. All measurements are made in an
ultraviolet spectrophotometer in optical cells of 5 centimeters in
length, and in the range of 255 millimicrons to 310 millimicrons, under
the same instrumental conditions. The standard reference absorbance is
the absorbance at 275 millimicrons of a standard reference solution of
naphthalene (National Bureau of Standards Material No. 577 or equivalent
in purity) containing a concentration of 1.4 milligrams per liter in
purified isooctane, measured against isooctane of the same spectral
purity in 5-centimeter cells. (This absorbance will be approximately
0.30.)
Solvent. The solvent used is pure grade isooctane having an
ultraviolet absorbance not to exceed 0.05 measured against distilled
water as a reference. Upon passage of purified inert gas through some
isooctane under the identical conditions of the test, a lowering of the
absorbance value has been observed. The absorbance of isooctane to be
used in this procedure shall not be more than 0.02 lower in the range
255 millimicrons to 310 millimicrons, inclusive, than that of the
untreated solvent as measured in a 5-centimeter cell. If necessary to
obtain the prescribed purities, the isooctane may be passed through
activated silica gel.
Apparatus. To assure reproducible results, the additive is passed
into the isooctane solution through a gas-absorption train consisting of
the following components and necessary connections:
1. A gas flow meter with a range up to 30 liters per hour provided
with a constant differential relay or other device to maintain a
constant flow rate independent of the input pressure.
2. An absorption apparatus consisting of an inlet gas dispersion
tube inserted to the bottom of a covered cylindrical vessel with a
suitable outlet on the vessel for effluent gas. The dimensions and
arrangement of tube and vessel are such that the inlet tube introduces
the gas at a point not above 5\1/4\ inches below the surface of the
solvent through a sintered glass outlet. The dimensions of the vessel
are such, and both inlet and vessel are so designed, that the gas can be
bubbled through 60 milliliters of isooctane solvent at a rate up to 30
liters per hour without mechanical loss of solvent. The level
corresponding to 60 milliliters should be marked on the vessel.
3. A cooling bath containing crushed ice and water to permit
immersion of the absorption vessel at least to the solvent level mark.
Caution. The various parts of the absorption train must be connected
by gas-tight tubing and joints composed of materials which will neither
remove components from

[[Page 143]]

nor add components to the gas stream. The gas source is connected in
series to the flow-rate device, the flow meter, and the absorption
apparatus in that order. Ventilation should be provided for the effluent
gases which may contain carbon monoxide.
Sampling procedure. Immerse the gas-absorption apparatus containing
60 milliliters of isooctane in the coolant bath so that the solvent is
completely immersed. Cool for at least 15 minutes and then pass 120
liters of the test gas through the absorption train at a rate of 30
liters per hour or less. Maintain the coolant bath at 0 deg.C
throughout. Remove the absorption vessel from the bath, disconnect, and
warm to room temperature. Add isooctane to bring the contents of the
absorption vessel to 60 milliliters, and mix. Determine the absorbance
of the solution in the 5-centimeter cell in the range 255 millimicrons
to 310 millimicrons, inclusive, compared to isooctane. The absorbance of
the solution of combustion product gas shall not exceed that of the
isooctane solvent at any wavelength in the specified range by more than
one-third of the standard reference absorbance.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.355]

[Page 143]

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. 173.355 Dichlorodifluoromethane.

The food additive dichlorodifluoromethane may be safely used in food
in accordance with the following prescribed conditions:
(a) The additive has a purity of not less than 99.97 percent.
(b) It is used or intended for use, in accordance with good
manufacturing practice, as a direct-contact freezing agent for foods.
(c) To assure safe use of the additive:
(1) The label of its container shall bear, in addition to the other
information required by the act, the following:
(i) The name of the additive, dichlorodifluoromethane, with or
without the parenthetical name "Food Freezant 12".
(ii) The designation "food grade".
(2) The label or labeling of the food additive container shall bear
adequate directions for use.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.357]

[Page 143-144]

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. 173.357 Materials used as fixing agents in the immobilization of enzyme preparations.

Fixing agents may be safely used in the immobilization of enzyme
preparations in accordance with the following conditions:
(a) The materials consist of one or more of the following:
(1) Substances generally recognized as safe in food.
(2) Substances identified in this subparagraph and subject to such
limitations as are provided:

------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Acrylamide-acrylic acid resin: May be used as a fixing material
Complying with Sec. 173.5(a)(1) and in the immobilization of glucose
(b) of this chapter. isomerase enzyme preparations
for use in the manufacture of
high fructose corn syrup, in
accordance with Sec. 184.1372
of this chapter.
Cellulose triacetate................. May be used as a fixing material
in the immobilization of lactase
for use in reducing the lactose
content of milk.
Diethylaminoethyl-cellulose.......... May be used as a fixing material
in the immobilization of glucose
isomerase enzyme preparations
for use in the manufacture of
high fructose corn syrup, in
accordance with Sec. 184.1372
of this chapter.
Dimethylamine-epichlorohydrin resin: May be used as a fixing material
Complying with Sec. 173.60(a) and in the immobilization of glucose
(b) of this chapter. isomerase enzyme preparations
for use in the manufacture of
high fructose corn syrup, in
accordance with Sec. 184.1372
of this chapter.
Glutaraldehyde....................... Do.
Periodic acid (CAS Reg. No. 10450-60-
9)..

[[Page 144]]

Polyethylenimine reaction product May be used as a fixing material
with 1,2-dichloroethane (CAS Reg.No. in the immobilization of
68130-97-2) is the reaction product glucoamylase enzyme preparations
of homopolymerization of from Aspergillus niger for use
ethylenimine in aqueous hydrochloric in the manufacture of beer.
acid at 100 deg.C and of cross- May be used as a fixing material
linking with 1,2-dichloroethane. The in the immobilization of:
finished polymer has an average 1. Glucose isomerase enzyme
molecular weight of 50,000 to 70,000 preparations for use in the
as determined by gel permeation manufacture of high fructose
chromatography. The analytical corn syrup, in accordance with
method is entitled "Methodology for Sec. 184.1372 of this chapter.
Molecular Weight Detection of 2. Glucoamylase enzyme
Polyethylenimine," which is preparations from Aspergillus
incorporated by reference in niger for use in the manufacture
accordance with 5 U.S.C. 552(a) and of beer. Residual ethylenimine
1 CFR part 51. Copies may be in the finished polyethylenimine
obtained from the Division of polymer will be less than 1 part
Petition Control, Center for Food per million as determined by gas
Safety and Applied Nutrition (HFS- chromatography-mass
200), 5100 Paint Branch Pkwy., spectrometry. The residual
College Park, MD 20740, and may be ethylenimine is determined by an
examined at the Center for Food analytical method entitled
Safety and Applied Nutrition's "Methodology for Ethylenimine
Library, 5100 Paint Branch Pkwy., Detection in Polyethylenimine,"
College Park, MD 20740, or at the which is incorporated by
Office of the Federal Register, 800 reference in accordance with 5
North Capitol St. NW., suite 700, U.S.C. 552(a) and 1 CFR part 51.
Washington, DC. Residual 1,2-dichloroethane in
the finished polyethylenimine
polymer will be less than 1 part
per million as determined by gas
chromatography. The residual 1,2-
dichloroethane is determined by
an analytical method entitled,
"Methodology for
Ethylenedichloride Detection in
Polyethylenimine," which is
incorporated by reference in
accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies may be
obtained from the Division of
Petition Control, Center for
Food Safety and Applied
Nutrition (HFS-215), 5100 Paint
Branch Pkwy., College Park, MD
20740, or may be examined at the
Center for Food Safety and
Applied Nutrition's Library,
5100 Paint Branch Pkwy., College
Park, MD 20740, or the Office of
the Federal Register, 800 North
Capitol St. NW., suite 700,
Washington, DC.
------------------------------------------------------------------------

(b) The fixed enzyme preparation is washed to remove residues of the
fixing materials.

[48 FR 5716, Feb. 8, 1983, as amended at 52 FR 39512, Oct. 22, 1987; 55
FR 12172, Apr. 2, 1990; 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9,
1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, June 25, 2002]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.360]

[Page 144]

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. 173.360 Octafluorocyclobutane.

The food additive octafluorocyclo-butane may be safely used as a
propellant and aerating agent in foamed or sprayed food products in
accordance with the following conditions:
(a) The food additive meets the following specifications:

99.99 percent octafluorocyclobutane.
Less than 0.1 part per million fluoroolefins, calculated as
perfluoroisobutylene.

(b) The additive is used or intended for use alone or with one or
more of the following substances: Carbon dioxide, nitrous oxide, and
propane, as a propellant and aerating agent for foamed or sprayed food
products, except for those standardized foods that do not provide for
such use.
(c) To assure safe use of the additive:
(1) The label of the food additive container shall bear, in addition
to the other information required by the act, the following:
(i) The name of the additive, octafluorocyclobutane.
(ii) The percentage of the additive present in the case of a
mixture.
(iii) The designation "food grade".
(2) The label or labeling of the food additive container shall bear
adequate directions for use.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.368]

[Page 144-145]

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. 173.368 Ozone.

Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment,
storage, and processing of foods, including meat and poultry (unless
such use is precluded by standards of identity in 9 CFR part 319), in
accordance with the following prescribed conditions:
(a) The additive is an unstable, colorless gas with a pungent,
characteristic odor, which occurs freely in nature. It is produced
commercially by passing electrical discharges or ionizing radiation
through air or oxygen.
(b) The additive is used as an antimicrobial agent as defined in
Sec. 170.3(o)(2) of this chapter.
(c) The additive meets the specifications for ozone in the Food
Chemicals Codex, 4th ed. (1996), p. 277, which is incorporated by
reference. The Director of the Office of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from the National Academy

[[Page 145]]

Press, 2101 Constitution Ave. NW., Washington, DC 20055, or may be
examined at the Office of Premarket Approval (HFS-200), Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, and the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(d) The additive is used in contact with food, including meat and
poultry (unless such use is precluded by standards of identity in 9 CFR
part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase
in accordance with current industry standards of good manufacturing
practice.
(e) When used on raw agricultural commodities, the use is consistent
with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act
(the act) and not applied for use under section 201(q)(1)(B)(i)(I),
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.

[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.370]

[Page 145]

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. 173.370 Peroxyacids.

Peroxyacids may be safely used in accordance with the following
prescribed conditions:
(a) The additive is a mixture of peroxyacetic acid, octanoic acid,
acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-
hydroxyethylidene-1,1-diphosphonic acid.
(b)(1) The additive is used as an antimicrobial agent on meat
carcasses, parts, trim, and organs in accordance with current industry
practice where the maximum concentration of peroxyacids is 220 parts per
million (ppm) as peroxyacetic acid, and the maximum concentration of
hydrogen peroxide is 75 ppm.
(2) The additive is used as an antimicrobial agent on poultry
carcasses, poultry parts, and organs in accordance with current industry
standards of good manufacturing practice (unless precluded by the U.S.
Department of Agriculture's standards of identity in 9 CFR part 381,
subpart P) where the maximum concentration of peroxyacids is 220 parts
per million (ppm) as peroxyacetic acid, the maximum concentration of
hydrogen peroxide is 110 ppm, and the maximum concentration of 1-
hydroxyethylidene-1,1-diphosphonic acid (HEDP) is 13 ppm.
(c) The concentrations of peroxyacids and hydrogen peroxide in the
additive are determined by a method entitled "Hydrogen Peroxide and
Peracid (as Peracetic Acid) Content," July 26, 2000, developed by
Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The
concentration of 1-hydroxyethylidene-1,1-diphosphonic acid is determined
by a method entitled "Determination of 1-hydroxyethylidene-1,1-
diphosphonic acid (HEDP) Peroxyacid/Peroxide-Containing Solutions,"
August 21, 2001, developed by Ecolab, Inc., St. Paul, MN, which is
incorporated by reference. The Director of the Office of the Federal
Register approves these incorporations by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of these methods
from the Division of Petition Review, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or you may examine a copy at the Center for Food
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the Office of the Federal Register, 800 North
Capitol St. NW., suite 700, Washington, DC.

[65 FR 70660, Nov. 27, 2000, as amended at 66 FR 48208, Sept. 19, 2001;
67 FR 61784, Oct. 2, 2002]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.385]

[Page 145]

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. 173.385 Sodium methyl sulfate.

Sodium methyl sulfate may be present in pectin in accordance with
the following conditions.
(a) It is present as the result of methylation of pectin by sulfuric
acid and methyl alcohol and subsequent treatment with sodium
bicarbonate.
(b) It does not exceed 0.1 percent by weight of the pectin.

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.395]

[Page 145-146]

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. 173.395 Trifluoromethane sulfonic acid.

Trifluoromethane sulfonic acid has the empirical formula
CF3SO3H (CAS Reg. No. 1493-13-6). The catalyst
(Trifluoromethane sulfonic acid) may safely be used in the production of
cocoa butter substitute from palm oil (1-palmitoyl-2-oleoyl-3-stearin)
(see

[[Page 146]]

Sec. 184.1259 of this chapter) in accordance with the following
conditions:
(a) The catalyst meets the following specifications:

Appearance, Clear liquid.
Color, Colorless to amber.
Neutralization equivalent, 147-151.
Water, 1 percent maximum.
Fluoride ion, 0.03 percent maximum.
Heavy metals (as Pb), 30 parts per million maximum.
Arsenic (as As), 3 parts per million maximum.

(b) It is used at levels not to exceed 0.2 percent of the reaction
mixture to catalyze the directed esterification.
(c) The esterification reaction is quenched with steam and water and
the catalyst is removed with the aqueous phase. Final traces of catalyst
are removed by washing batches of the product three times with an
aqueous solution of 0.5 percent sodium bicarbonate.
(d) No residual catalyst may remain in the product at a detection
limit of 0.2 part per million fluoride as determined by the method
described in "Official Methods of Analysis of the Association of
Official Analytical Chemists," sections 25.049-25.055, 13th Ed. (1980),
which is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.

[43 FR 54237, Nov. 11, 1978, as amended at 49 FR 10106, Mar. 19, 1984;
54 FR 24897, June 12, 1989]

[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR173.400]

[Page 146-147]

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. 173.400 Dimethyldialkylammonium chloride.

Dimethyldialkylammonium chloride may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is produced by one of the following methods:
(1) Ammonolysis of natural tallow fatty acids to form amines that
are subsequently reacted with methyl chloride to form the quaternary
ammonium compounds consisting primarily of dimethyldioctadecylammonium
chloride and dimethyldihexadecylammonium chloride. The additive may
contain residues of isopropyl alcohol not in excess of 18 percent by
weight when used as a processing solvent.
(2) Ammonolysis of natural tallow fatty acids to form amines that
are then reacted with 2-ethylhexanal, reduced, methylated, and
subsequently reacted with methyl chloride to form the quaternary
ammonium compound known as dimethyl(2-ethylhexyl) hydrogenated tallow
ammonium chloride and consisting primarily of dimethyl(2-
ethylhexyl)octadecylammonium chloride and dimethyl(2-
ethylhexyl)hexadecylammonium chloride.
(b) The food additive described in paragraph (a)(1) of this section
contains not more than a total of 2 percent by weight of free amine and
amine hydrochloride. The food additive described in paragraph (a)(2) of
this section contains not more than 3 percent by weight, each, of free
amine and amine hydrochloride as determined by A.O.C.S. method Te 3a-64,
"Acid Value and Free Amine Value of Fatty Quaternary Ammonium
Chlorides," 2d printing including additions and revisions 1990, which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, and from the American Oil
Chemists' Society, P.O. Box 5037, Station A, Champaign, IL 61820, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC.
(c) The food additive is used as a decolorizing agent in the
clarification of refinery sugar liquors under the following limitations:
(1) The food additive described in paragraph (a)(1) of this section
is added only at the defecation/clarification stage of sugar liquor
refining in an amount not to exceed 700 parts per million by weight of
sugar solids.
(2) The food additive described in paragraph (a)(2) of this section
is used under the following conditions:
(i) The additive is adsorbed onto a support column composed of
suitable

[[Page 147]]

polymers that are regulated for contact with aqueous food. Excess
nonadsorbed additive shall be rinsed away with potable water prior to
passage of sugar liquor through the column.
(ii) The residue of the additive in the decolorized sugar liquor
prior to crystallization shall not exceed 1 part per million of sugar as
determined by a method entitled "Colorimetric Determination of Residual
Quaternary Ammonium Compounds (Arquad HTL8) in Sugar and Sugar
Solutions," June 13, 1990, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(d) To assure safe use of the additive, the label and labeling of
the additive shall bear, in addition to other information required by
the Federal Food, Drug, and Cosmetic Act, adequate directions to assure
use in compliance with paragraph (c) of this section.

[56 FR 42686, Aug. 29, 1991]

Food Code 2001

FDA/Center for Food Safety & Applied Nutrition