Title 21—Food and Drugs--Volume 1
PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
§ 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.
(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.
§ 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 β-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.
§ 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 § 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.
§ 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 § 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° (158 °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 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.
§ 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 National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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].
(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 °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 § 176.170(c) of this chapter: Provided, That the temperature of the water or food passing through the resin beds is maintained at 50 °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 § 176.170(c) of this chapter: Provided, That the temperature of the water or food passing through the resin bed is maintained at 50 °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 § 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 °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
(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 § 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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 °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 °C (179.6 °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 °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 °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 °C; this is total extractives. This residue is fired in a muffle furnace at 850 °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:
(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 § 180.22 of this chapter.
§ 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.
§ 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or are available for inspection at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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.
§ 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.
§ 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:
§ 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 °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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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.
§ 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. 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 °C (175 °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 § 176.170 of this chapter.
§ 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.
§ 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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.
§ 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.
§ 173.110   Amyloglucosidase derived fromRhizopus niveus.
Amyloglucosidase enzyme product, consisting of enzyme derived from Rhizopus niveus, and diatomaceous silica as a carrier, may be safely used in 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.
§ 173.115   Alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis.
The food additive alpha-acetolactate decarboxylase (α-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 α-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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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.
§ 173.120   Carbohydrase and cellulase derived fromAspergillus 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.
§ 173.130   Carbohydrase derived fromRhizopus 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.
(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.
§ 173.135   Catalase derived fromMicrococcus 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.
§ 173.140   Esterase-lipase derived fromMucor 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 § 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 § 170.3(n)(5) of this chapter; fat and oils as defined in § 170.(3)(n)(12) of this chapter; and milk products as defined in § 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.
§ 173.145   Alpha-Galactosidase derived fromMortierella vinaceaevar.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.
(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.
§ 173.150   Milk-clotting enzymes, microbial.
Milk-clotting enzyme produced by pure-culture fermentation process may 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.
§ 173.160Candida 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.
(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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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, 7th ed. (2010), pp. 226-227, 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. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
§ 173.165Candida 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:
(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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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, 7th ed. (2010), pp. 226-227, 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. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. The additive meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in this paragraph:
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.
1. Aluminum foil, oil free.
2. Separatory funnels, 500-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks.
3. Chromatographic tubes: (a) 80-millimeter ID × 900-millimeter length equipped with tetrafluoroethylene polymer stopcock and course fritted disk; (b) 18-millimeter ID × 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 × 200 mm × 300 mm deep.
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 °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.
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 × 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° to 177 °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 § 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.
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 °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 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 × 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 °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 °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.
§ 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 kan r gene originally isolated from transposon Tn 5 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 kan r gene along with the genetic material of interest.
§ 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.
§ 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 °C: 1.004 to 1.006.
(3) Distillation range: 200°-215 °C.
(b) It is used in the minimum amount required to perform its intended effect.
(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.
§ 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, 7th ed. (2010), pp. 343-344, 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. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(b) The additive is used in accordance with current good manufacturing practice as a solvent in the decaffeination of coffee and tea.
§ 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.
§ 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.
§ 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.
§ 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).
§ 173.270   Hexane.
Hexane 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 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.
§ 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.
§ 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 § 172.864 of this chapter, synthetic isoparaffinic petroleum hydrocarbons meeting the requirements of § 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 polynuclear aromatic hydrocarbon specifications of § 173.165 and the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 226-227, 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. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(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.
§ 173.290   Trichloroethylene.
Tolerances are established for residues of trichloroethylene resulting from its use as a solvent in the manufacture of foods as follows:
§ 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)(1) The additive is generated by one of the following methods:
(i) Treating an aqueous solution of sodium chlorite with either chlorine gas or a mixture of sodium hypochlorite and hydrochloric acid.
(ii) Treating an aqueous solution of sodium chlorate with hydrogen peroxide in the presence of sulfuric acid.
(iii) Treating an aqueous solution of sodium chlorite by electrolysis.
(2) The generator effluent contains at least 90 percent (by weight) of chlorine dioxide with respect to all chlorine species as determined by Method 4500-ClO 2 E in the “Standard Methods for the Examination of Water and Wastewater,” 20th ed., 1998, or an equivalent method. Method 4500-ClO 2 E (“Amperometric Method II”) is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or the American Public Health Association, 800 I St. NW., Washington, DC 20001-3750. You may inspect a copy at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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-ClO 2 E, referenced in paragraph (a)(2) 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-ClO 2 E, referenced in paragraph (a)(2) 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.
§ 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:
(d) Substances used alone or in combination with substances in paragraph (c) of this section:
(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.
(f) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday:
(i) “Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS” (October 23, 1987).
(ii) [Reserved]
(2) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ):
(i) Food Chemicals Codex, 7th ed. (2010), pp. 1128-1129.
(ii) Food Chemicals Codex, 7th ed. (2010), pp. 825-827.
§ 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:
(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:
(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:
(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.
§ 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:
(2) Combination for cane-sugar mills:
(3) Combinations for cane-sugar mills and beet-sugar mills:
(4) Single additive for cane-sugar mills and beet-sugar mills.
(5) Combination for cane-sugar mills:
(6) Single additive for beet-sugar mills:
(c) To assure safe use of the additives, their label and labeling shall conform to that registered with the Environmental Protection Agency.
§ 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:
§ 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.
(d)(1) 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.
(2) The additive is used as a single application in processing facilities as an antimicrobial agent to reduce pathogenic bacteria due to cross-contamination during the harvesting, handling, heading, evisceration, butchering, storing, holding, packing, or packaging of finfish and crustaceans; or following the filleting of finfish; 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 a sodium chlorite concentration of 1,200 ppm, in combination with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. Treated seafood shall be cooked 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
§ 173.340   Defoaming agents.
Defoaming agents may be safely used in processing foods, in accordance with the following conditions:
(a) They consist of one or more of the following:
(1) Substances generally recognized by qualified experts as safe in food or covered by prior sanctions for the use prescribed by this section.
(2) Substances listed in this paragraph (a)(2) of this section, subject to any limitations imposed:
(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:
(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:
(b) They are added in an amount not in excess of that reasonably required to inhibit foaming.
§ 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 § 179.45 of this chapter and conforming to any limitations or specifications in such regulations.
§ 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 § 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 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.
§ 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 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 °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.
§ 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.
§ 173.356   Hydrogen peroxide.
Hydrogen peroxide (CAS Reg. No. 7722-84-1) may be safely used to treat food in accordance with the following conditions:
(a) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 496 and 497, which is incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) The additive is used as an antimicrobial agent in the production of modified whey (including, but not limited to, whey protein concentrates and whey protein isolates) by ultrafiltration methods, at a level not to exceed 0.001 percent by weight of the whey, providing that residual hydrogen peroxide is removed by appropriate chemical or physical means during the processing of the modified whey.
§ 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:
(b) The fixed enzyme preparation is washed to remove residues of the fixing materials.
§ 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:
(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.
§ 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 § 170.3(o)(2) of this chapter.
(c) The additive meets the specifications for ozone in the Food Chemicals Codex, 7th ed. (2010), pp. 754-755, 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. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(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.
§ 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or you may examine a copy at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
§ 173.375   Cetylpyridinium chloride.
Cetylpyridinium chloride (CAS Reg. No. 123-93-5) may be safely used in food in accordance with the following conditions:
(a) The additive meets the specifications of the United States Pharmacopeia (USP)/National Formulary (NF) described in USP 30/NF 25, May 1, 2007, pp. 1700-1701, 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. You may obtain copies from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or you may examine a copy at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(b) The additive is used in food as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter to treat the surface of raw poultry carcasses. The solution in which the additive is used to treat raw poultry carcasses shall also contain propylene glycol (CAS Reg. No. 57-55-6) complying with § 184.1666 of this chapter, at a concentration of 1.5 times that of cetylpyridinium chloride.
(c) The additive is used as follows:
(1) As a fine mist spray of an ambient temperature aqueous solution applied to raw poultry carcasses prior to immersion in a chiller, at a level not to exceed 0.3 gram cetylpyridinium chloride per pound of raw poultry carcass, provided that the additive is used in systems that collect and recycle solution that is not carried out of the system with the treated poultry carcasses; or
(2) As a liquid aqueous solution applied to raw poultry carcasses either prior to or after chilling at an amount not to exceed 5 gallons of solution per carcass, provided that the additive is used in systems that recapture at least 99 percent of the solution that is applied to the poultry carcasses. The concentration of cetylpyridinium chloride in the solution applied to the carcasses shall not exceed 0.8 percent by weight. When application of the additive is not followed by immersion in a chiller, the treatment will be followed by a potable water rinse of the carcass.
§ 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.
§ 173.395   Trifluoromethane sulfonic acid.
Trifluoromethane sulfonic acid has the empirical formula CF 3 SO 3 H (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 § 184.1259 of this chapter) in accordance with the following conditions:
(a) The catalyst meets the following specifications:
(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 AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
§ 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, and from the American Oil Chemists' Society, P.O. Box 5037, Station A, Champaign, IL 61820, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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 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 Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(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.
§ 173.405   Sodium dodecylbenzenesulfonate.
Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) may be safely used in accordance with the following prescribed conditions:
(a) The additive is an antimicrobial agent used in wash water for fruits and vegetables. The additive may be used at a level not to exceed 111 milligrams per kilogram in the wash water. Fruits and vegetables treated by the additive do not require a potable water rinse.
(b) The additive is limited to use in commissaries, cafeterias, restaurants, retail food establishments, nonprofit food establishments, and other food service operations in which food is prepared for or served directly to the consumer.
(c) To assure safe use of the additive, the label or labeling of the additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with the provisions of this section.