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:
 
------------------------------------------------------------------------
                                                                  Parts
                                                                   per
                                                                 million
------------------------------------------------------------------------
Disodium ethylenebisdithiocarbamate............................      3.0
Sodium dimethyldithiocarbamate.................................      3.0
------------------------------------------------------------------------
 
    (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]
 
 
 
 
horizontal rule
horizontal rule