Secondary direct food additives permitted in food for human consumption (21 CFR 173.5-173.405)

124 21 CFR Ch. I (4–1–16 Edition) § 172.898 safely used in food provided the total folic acid content of the yeast does not exceed 0.04 milligram per gram of yeast (approximately 0.008 milligram of pteroyglutamic acid per gram of yeast). § 172.898 Bakers yeast glycan. Bakers yeast glycan may be safely used in food in accordance with the fol lowing conditions: (a) Bakers yeast glycan is the comminuted, washed, pasteurized, and dried cell walls of the yeast, Saccharo myces cerevisiae. It is composed prin cipally of long chain carbohydrates, not less than 85 percent on a dry solids basis. The carbohydrate is composed of glycan and mannan units in approxi mately a 2:1 ratio. (b) The additive meets the following specifications on a dry weight basis: Less than 0.4 part per million (ppm) ar senic, 0.13 ppm cadmium, 0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc. (c) The viable microbial content of the finished ingredient is: (1) Less than 10,000 organisms/gram by aerobic plate count. (2) Less than 10 yeasts and molds/ gram. (3) Negative for Salmonella, E. coli, coagulase positive Staphylococci, Clos tridium perfringens, Clostridium botu linum, or any other recognized micro bial pathogen or any harmful microbial toxin. (d) The additive is used or intended for use in the following foods when standards of identity established under section 401 of the Act do not preclude such use: Use Limitations (1) In salad dressings as an emul sifier and emulsifier salt as de fined in § 170.3(o)(8) of this chapter, stabilizer and thickener as defined in § 170.3(o)(28) of this chapter, or texturizer as de fined in § 170.3(o)(32) of this chapter. Not to exceed a con centration of 5 percent of the finished salad dressing. (2) In frozen dessert analogs as a stabilizer and thickener as de fined in § 170.3(o)(28) of this chapter, or texturizer as defined in § 170.3(o)(32) of this chapter. In an amount not to ex ceed good manufac turing practice. (3) In sour cream analogs as a stabilizer and thickener as de fined in § 170.3(o)(28) of this chapter, or texturizer as defined in § 170.3(o)(32) of this chapter. Do. Use Limitations (4) In cheese spread analogs as a stabilizer and thickener as de fined in § 170.3(o)(28) of this chapter, or texturizer as defined in § 170.3(o)(32) of this chapter. Do. (5) In cheese-flavored and sour cream-flavored snack dips as a stabilizer and thickener as de fined in § 170.3(o)(28) of this chapter, or texturizer as defined in § 170.3(o)(32) of this chapter. Do. (e) The label and labeling of the in gredient shall bear adequate directions to assure that use of the ingredient complies with this regulation. [42 FR 14491, Mar. 15, 1977, as amended at 45 FR 58836, Sept. 5, 1980] PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMP TION Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment Sec. 173.5 Acrylate-acrylamide resins. 173.10 Modified polyacrylamide resin. 173.20 Ion-exchange membranes. 173.21 Perfluorinated ion exchange mem branes. 173.25 Ion-exchange resins. 173.40 Molecular sieve resins. 173.45 Polymaleic acid and its sodium salt. 173.50 Polyvinylpolypyrrolidone. 173.55 Polyvinylpyrrolidone. 173.60 Dimethylamine-epichlorohydrin co polymer. 173.65 Divinylbenzene copolymer. 173.70 Chloromethylated aminated styrene divinylbenzene resin. 173.73 Sodium polyacrylate. 173.75 Sorbitan monooleate. Subpart B—Enzyme Preparations and Microorganisms 173.110 Amyloglucosidase derived from Rhizopus niveus. 173.115 Alpha-acetolactate decarboxylase (a ALDC) enzyme preparation derived from a recombinant Bacillus subtilis. 173.120 Carbohydrase and cellulase derived from Aspergillus niger. 173.130 Carbohydrase derived from Rhizopus oryzae. 173.135 Catalase derived from Microccocus lysodeikticus. 173.140 Esterase-lipase derived from Mucor miehei. 173.145 Alpha-Galactosidase derived from Mortierella vinaceae var. raffinoseutilizer. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00134 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 125 Food and Drug Administration, HHS § 173.10 173.150 Milk-clotting enzymes, microbial. 173.160 Candida guilliermondii. 173.165 Candida lipolytica. 173.170 Aminoglycoside 3′-phospho transferase II. Subpart C—Solvents, Lubricants, Release Agents and Related Substances 173.210 Acetone. 173.220 1,3–Butylene glycol. 173.228 Ethyl acetate. 173.230 Ethylene dichloride. 173.240 Isopropyl alcohol. 173.250 Methyl alcohol residues. 173.255 Methylene chloride. 173.270 Hexane. 173.275 Hydrogenated sperm oil. 173.280 Solvent extraction process for citric acid. 173.290 Trichloroethylene. Subpart D—Specific Usage Additives 173.300 Chlorine dioxide. 173.310 Boiler water additives. 173.315 Chemicals used in washing or to as sist in the peeling of fruits and vegeta bles. 173.320 Chemicals for controlling micro organisms in cane-sugar and beet-sugar mills. 173.322 Chemicals used in delinting cotton seed. 173.325 Acidified sodium chlorite solutions. 173.340 Defoaming agents. 173.342 Chlorofluorocarbon 113 and perfluorohexane. 173.345 Chloropentafluoroethane. 173.350 Combustion product gas. 173.355 Dichlorodifluoromethane. 173.356 Hydrogen peroxide. 173.357 Materials used as fixing agents in the immobilization of enzyme prepara tions. 173.360 Octafluorocyclobutane. 173.368 Ozone. 173.370 Peroxyacids. 173.375 Cetylpyridinium chloride. 173.385 Sodium methyl sulfate. 173.395 Trifluoromethane sulfonic acid. 173.400 Dimethyldialkylammonium chlo ride. 173.405 Sodium dodecylbenzenesulfonate. AUTHORITY: 21 U.S.C. 321, 342, 348. SOURCE: 42 FR 14526, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 173 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. 27, 2001. Subpart A—Polymer Substances and Polymer Adjuvants for Food Treatment § 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 pro duced by the polymerization of acryl amide with partial hydrolysis, or by copolymerization of acrylamide and acrylic acid, with the greater part of the polymer being composed of acryl amide units. (2) Sodium polyacrylate-acrylamide resin is produced by the polymerization and subsequent hydrolysis of acrylo nitrile in a sodium silicate-sodium hy droxide aqueous solution, with the greater part of the polymer being com posed 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 para graph (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 ex ceed 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 para graph (a)(2) of this section is used to control organic and mineral scale in beet sugar juice and liquor or cane sugar juice and liquor in an amount not to exceed 2.5 parts per million by weight of the juice or liquor. [42 FR 14526, Mar. 15, 1977, as amended at 46 FR 30494, June 9, 1981] § 173.10 Modified polyacrylamide resin. Modified polyacrylamide resin may be safely used in food in accordance with the following prescribed condi tions: VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00135 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 126 21 CFR Ch. I (4–1–16 Edition) § 173.20 (a) The modified polyacrylamide resin is produced by the copolymeriza tion of acrylamide with not more than 5–mole percent b-methacrylyloxyethy ltrimethylammonium methyl sulfate. (b) The modified polyacrylamide resin contains not more than 0.05 per cent residual acrylamide. (c) The modified polyacrylamide resin is used as a flocculent in the clar ification 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 in formation required by the act, ade quate directions to assure use in com pliance with paragraph (c) of this sec tion. § 173.20 Ion-exchange membranes. Ion-exchange membranes may be safely used in the processing of food under the following prescribed condi tions: (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 trimethyl amine, dimethylamine, diethylene triamine, 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 mem brane weighing approximately 14 grams each are cut into small pieces and refluxed for 4 hours in 150 cubic centi meters of the following solvents: Dis tilled 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 pre scribed conditions: (a) Identity. The membrane is a co polymer of ethanesulfonyl fluoride, 2 [1-[difluoro-[(trifluoro ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro ethoxy]-1,1,2,2,-tetrafluoro-, with tetra fluoroethylene that has been subse quently 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-[(trifluoro ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro ethoxy]-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 accord ance with § 174.5 of this chapter. (c) Conditions of use. (1) Perfluorinated ion exchange mem branes described in paragraph (a) of this section may be used in contact with all types of liquid foods at tem peratures not exceeding 70° (158 °F). (2) Maximum thickness of the copoly mer membrane is 0.007 inch (0.017 centi meter). (3) Perfluorinated ion exchange mem branes shall be maintained in a sani tary manner in accordance with cur rent 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 cur rent good manufacturing practice. [59 FR 15623, Apr. 4, 1994] § 173.25 Ion-exchange resins. Ion-exchange resins may be safely used in the treatment of food under the following prescribed conditions: VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00136 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 127 Food and Drug Administration, HHS § 173.25 (a) The ion-exchange resins are pre pared in appropriate physical form, and consist of one or more of the following: (1) Sulfonated copolymer of styrene and divinylbenzene. (2) Sulfonated anthracite coal meet ing 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 avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (3) Sulfite-modified cross-linked phe nol-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 fol lowing: Triethylene tetramine and tetraethylenepentamine. (8) Reaction resin of formaldehyde, acetone, and tetraethylenepentamine. (9) Completely hydrolyzed copoly mers of methyl acrylate and divinylbenzene. (10) Completely hydrolyzed terpolymers of methyl acrylate, divinylbenzene, and acrylonitrile. (11) Sulfonated terpolymers of sty rene, 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 sty rene, divinylbenzene, acrylonitrile, and methyl acrylate derived from a mix ture of monomers containing not more than a total of 2 percent by weight of acrylonitrile and methyl acrylate. (16) Methyl acrylate-divinylbenzene diethylene 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 dimethyl aminopropylamine. (17) Styrene-divinylbenzene cross linked copolymer, first chloromethylated then aminated with dimethylamine and oxidized with hy drogen peroxide whereby the resin con tains not more than 15 percent by weight of vinyl N,N-dimethylbenzyl amine-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 dimethyl aminopropylamine 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 ca pacity by weight of total exchange ca pacity [Chemical Abstracts Service name: Oxirane (chloromethyl)-, poly mer with ammonia, reaction product with chloromethane; CAS Reg. No. 68036–99–7]. (20) Regenerated cellulose, cross linked and alkylated with epichloro hydrin and propylene oxide, then sulfo nated whereby the amount of epi chlorohydrin plus propylene oxide em ployed does not exceed 250 percent by weight of the starting quantity of cel lulose. (b) Ion-exchange resins are used in the purification of foods, including po table water, to remove undesirable ions or to replace less desirable ions with VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00137 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 128 21 CFR Ch. I (4–1–16 Edition) § 173.25 one or more of the following: bicarbon ate, calcium, carbonate, chloride, hy drogen, hydroxyl, magnesium, potas sium, 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 accord ance 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 para graph (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 alco holic beverages, subject to the fol lowing conditions: (i) The water is subjected to treat ment through a mixed bed consisting of one of the resins identified in para graph (a) (12) or (16) of this section and one of the strongly acidic cation-ex change 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 para graph (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-ex change 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 identi fied 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 identi fied in paragraph (a) (12) or (16) of this section are exempted from the require ments of paragraph (c)(4) of this sec tion, but the strongly acidic cation-ex change 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 para graph (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 identi fied 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 pass ing 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 cat egories 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 gal lon 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 cat egories 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 gal lon 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00138 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 129 Food and Drug Administration, HHS § 173.25 Resins,’’ February 4, 1998, which is in corporated 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, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1200, or may be examined at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.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 treat ment of municipal water supplies, sub ject to the condition that the tempera ture 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 tem perature 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 purifi cation of protein concentrates and iso lates 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 ac cordance with the manufacturer’s di rections prescribed on the label or la beling 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 sol vents, distilled water, 15 percent alco hol, and 5 percent acetic acid when, having been washed and otherwise treated in accordance with the manu facturer’s directions for preparing them for use with food, the ion-ex change resin is subjected to the fol lowing test: Using a separate ion-ex change column for each solvent, pre pare 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 en countered in use pass through these beds at the rate of 350–450 milliliters per hour the three test solvents dis tilled 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 extrac tives. 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 sol vent and a correction should be made by subtracting the total extractives ob tained with the blank from the total VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00139 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 130 21 CFR Ch. I (4–1–16 Edition) § 173.40 extractives obtained in the resin test. The solvents used are to be made as follows: Distilled water (de-ionized water is distilled). 15 percent ethyl alcohol made by mixing 15 volumes of absolute ethyl alcohol A.C.S. reagent grade, with 85 volumes of distilled de-ionized water. 5 percent acetic acid made by mixing 5 parts by weight of A.C.S. reagent grade glacial acetic acid with 95 parts by weight of dis tilled de-ionized water. In addition to the organic extractives limitation prescribed in this para graph, the ion-exchange resin identi fied in paragraph (a)(17) of this section, when extracted with each of the named solvents, distilled water, 50 percent al cohol, and 5 percent acetic acid, will be found to result in not more than 7 parts per million of nitrogen extrac tives (calculated as nitrogen) when the resin in the free-base form is subjected to the following test immediately be fore each use: Using a separate 1–inch diameter glass ion-exchange column for each solvent, prepare each column using 100 milliliters of ready to use ion exchange resin that is to be tested. With the bottom outlet closed, fill each ion-exchange column with one of the three solvents at a temperature of 25 °C until the solvent level is even with the top of the resin bed. Seal each column at the top and bottom and store in a vertical position at a temperature of 25 °C. After 96 hours, open the top of each column, drain the solvent into a collec tion vessel, and analyze each drained solvent and a solvent blank for nitro gen by a standard micro-Kjeldahl method. (d)(1) The ion-exchange resins identi fied in paragraphs (a)(1), (a)(2), (a)(11), and (a)(15) of this section are exempted from the acetic acid extraction re quirement 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 sub stitute for acetic acid; or (ii) The extraction requirement in paragraph (c)(4) of this section by using reagent grade hydrochloric acid, di luted 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 hydro chloric acid, pH 2. Blanks should be run for each of the solvents, and correc tions should be made by subtracting the total extractives obtained with the blank from the total extractives ob tained in the resin test. (e) Acrylonitrile copolymers identi fied in this section shall comply with the provisions of § 180.22 of this chap ter. [42 FR 14526, Mar. 15, 1977, as amended at 46 FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20, 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR 14609, Mar. 26, 1999; 64 FR 56173, Oct. 18, 1999; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, 2016] § 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 pu rification 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 so dium 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 pre scribed conditions: VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00140 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 131 Food and Drug Administration, HHS § 173.55 (a) The additives have a weight-aver age molecular weight in the range of 540 to 850 and a number-average molec ular weight in the range of 520 to 650, calculated as the acid. Molecular weights shall be determined by a meth od entitled ‘‘Determination of Molec ular Weight Distribution of Poly(Maleic) Acid,’’ March 17, 1992, pro duced by Ciba-Geigy, Inc., Seven Sky line 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 Ad ministration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1200, or are available for inspection at the Food and Drug Administration’s Main Li brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (b) The additives may be used, indi vidually or together, in the processing of beet sugar juice and liquor or of cane sugar juice and liquor to control min eral scale. (c) The additives are to be used so that the amount of either or both addi tives does not exceed 4 parts per mil lion (calculated as the acid) by weight of the beet or cane sugar juice or liquor process stream. [51 FR 5315, Feb. 13, 1986, as amended at 61 FR 386, Jan. 5, 1996; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, 2016] § 173.50 Polyvinylpolypyrrolidone. The food additive polyvinylpoly pyrrolidone may be safely used in ac cordance 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 per cent acetic acid, and 50 percent alco hol, 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 vin egar, followed by removal with filtra tion. § 173.55 Polyvinylpyrrolidone. The food additive polyvinylpyrroli done may be safely used in accordance with the following prescribed condi tions: (a) The additive is a polymer of puri fied vinylpyrrolidone catalytically pro duced, having an average molecular weight of 40,000 and a maximum unsaturation of 1 percent, calculated as the monomer, except that the polyvinylpyrrolidone used in beer is that having an average molecular weight of 360,000 and a maximum unsaturation of 1 percent, calculated as the monomer. (b) The additive is used or intended for use in foods as follows: Food Limitations Beer ......................................................................... As a clarifying agent, at a residual level not to exceed 10 parts per million. Flavor concentrates in tablet form .......................... As a tableting adjuvent in an amount not to exceed good manufacturing practice. Nonnutritive sweeteners in concentrated liquid form. As a stabilizer, bodying agent, and dispersant, in an amount not to exceed good manufacturing practice. Nonnutritive sweeteners in tablet form ................... As a tableting adjuvant in an amount not to exceed good manufacturing practice. Vitamin and mineral concentrates in liquid form .... As a stabilizer, bodying agent, and dispersant, in an amount not to exceed good manufacturing practice. Vitamin and mineral concentrates in tablet form .... As a tableting adjuvant in an amount not to exceed good manufacturing practice. Vinegar .................................................................... As a clarifying agent, at a residual level not to exceed 40 parts per million. Wine ........................................................................ As a clarifying agent, at a residual level not to exceed 60 parts per million. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00141 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 132 21 CFR Ch. I (4–1–16 Edition) § 173.60 § 173.60 Dimethylamine epichlorohydrin copolymer. Dimethylamine-epichlorohydrin co polymer (CAS Reg. No. 25988–97–0) may be safely used in food in accordance with the following prescribed condi tions: (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 co polymer 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 min imum viscosity of 175 centipoises at 25 °C as determined by LVT-series Brook field 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 Deter mination of Epichlorohydrin and 1,3 Dichloro-2-Propanol in Dimethyl amine-Epichlorohydrin Copolymer,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspec tion 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/ federallregister/ codeloflfederallregulations/ ibrllocations.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 de colorizing agent and/or flocculant in the clarification of refinery sugar liq uors 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 co polymer 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 infor mation required by the Act, adequate directions to assure use in compliance with paragraph (c) of this section. [48 FR 37614, Aug. 19, 1983, as amended at 54 FR 24897, June 12, 1989] § 173.65 Divinylbenzene copolymer. Divinylbenzene copolymer may be used for the removal of organic sub stances from aqueous foods under the following prescribed conditions: (a) The copolymer is prepared in ap propriate 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 ethylvinyl benzene, and no more than 4 weight percent nonpolymerizable impurities. (b) In accordance with the manufac turer’s directions, the copolymer de scribed 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 Determina tion of Divinylbenzene in Alcohol Ex tracts of Amberlite XAD–4,’’ which is incorporated by reference. Copies of this method are available from the Center for Food Safety and Applied Nu trition (HFS–200), Food and Drug Ad ministration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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/ federallregister/ codeloflfederallregulations/ ibrllocations.html. The copolymer is then treated with water according to the manufacturer’s recommendation to remove the extraction solvent to guar antee 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. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00142 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 133 Food and Drug Administration, HHS § 173.75 (d) The copolymer may be used in contact with food only of Types I, II, and VI-B (excluding carbonated bev erages) described in table 1 of para graph (c) of § 176.170 of this chapter. [50 FR 61, Jan. 2, 1985] § 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 disper sion of styrene-divinylbenzene copoly mers, 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 fol lows: One hundred grams of the addi tive 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 non volatile solubles is obtained by divid ing the weight of the dried residue by the weight of the solids in the original resin dispersion. (c) The additive is used as a decol orizing and clarification agent for treatment of refinery sugar liquors and juices at levels not to exceed 500 parts of additive solids per million parts of sugar solids. [50 FR 29209, July 18, 1985] § 173.73 Sodium polyacrylate. Sodium polyacrylate (CAS Reg. No. 9003–04–7) may be safely used in food in accordance with the following pre scribed conditions: (a) The additive is produced by the polymerization of acrylic acid and sub sequent hydrolysis of the polyacrylic acid with an aqueous sodium hydroxide solution. As determined by a method entitled ‘‘Determination of Weight Av erage and Number Average Molecular Weight of Sodium Polyacrylate,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a), the ad ditive 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. Cop ies of the method are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.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. [53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, 1988] § 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 commer cial oleic acid. (b) It meets the following specifica tions: (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 dis persions that are used in the clarifica tion of cane or beet sugar juice or liq uor in an amount not to exceed 7.5 per cent by weight in the final polymer dis persion. (2) The additive is used in an amount not to exceed 0.70 part per million in sugar juice and 1.4 parts per million in sugar liquor. [51 FR 11720, Apr. 7, 1986] VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00143 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 134 21 CFR Ch. I (4–1–16 Edition) § 173.110 Subpart B—Enzyme Preparations and Microorganisms § 173.110 Amyloglucosidase derived from Rhizopus niveus. Amyloglucosidase enzyme product, consisting of enzyme derived from Rhizopus niveus, and diatomaceous sili ca as a carrier, may be safely used in food in accordance with the following conditions: (a) Rhizopus niveus is classified as fol lows: 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 proc ess which completely removes the or ganism Rhizopus niveus from the amyloglucosidase. (d) The additive is used or intended for use for degrading gelatinized starch into constituent sugars, in the produc tion 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 recom binant Bacillus subtilis. The food additive alpha-acetolactate decarboxylase (a-ALDC) enzyme prepa ration, may be safely used in accord ance 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 a-ALDC from Bacillus brevis. (b)(1) The manufacturer produces the additive from a pure culture fermenta tion 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 re quirements 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 in corporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Na tional Academy Press, 2101 Constitu tion Ave. NW., Washington, DC 20055, or may be examined at the Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 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/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (c) The additive is used in an amount not in excess of the minimum required to produce its intended effect as a proc essing aid in the production of alco holic malt beverages and distilled liq uors. [66 FR 27022, May 16, 2001] § 173.120 Carbohydrase and cellulase derived from Aspergillus niger. Carbohydrase and cellulase enzyme preparation derived from Aspergillus niger may be safely used in food in ac cordance 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 (bel lies) 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 from Rhizopus oryzae. Carbohydrase from Rhizopus oryzae may be safely used in the production of VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00144 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 135 Food and Drug Administration, HHS § 173.145 1 Available from: American Type Culture Collection, 12301 Parklawn Drive, Rockville, MD 20852. dextrose from starch in accordance with the following prescribed condi tions: (a) Rhizopus oryzae is classified as fol lows: 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 main tain 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 neces sity of refrigerated storage. § 173.135 Catalase derived from Micro coccus lysodeikticus. Bacterial catalase derived from Micrococcus lysodeikticus by a pure cul ture fermentation process may be safe ly used in destroying and removing hy drogen peroxide used in the manufac ture of cheese, in accordance with the following conditions. (a) The organism Micrococcus lysodeikticus from which the bacterial catalase is to be derived is dem onstrated to be nontoxic and nonpatho genic. (b) The organism Micrococcus lysodeikticus is removed from the bac terial catalase prior to use of the bac terial catalase. (c) The bacterial catalase is used in an amount not in excess of the min imum required to produce its intended effect. § 173.140 Esterase-lipase derived from Mucor miehei. Esterase-lipase enzyme, consisting of enzyme derived from Mucor miehei var. Cooney et Emerson by a pure culture fer mentation 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 Emer son 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 proc ess which completely removes the or ganism 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 cat egories: cheeses as defined in § 170.3(n)(5) of this chapter; fat and oils as defined in § 170.(3)(n)(12) of this chap ter; 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 min imum amount required to produce its limited technical effect. [47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, 1983] § 173.145 Alpha-Galactosidase derived from Mortierella vinaceae var. raffinoseutilizer. The food additive alpha-galactosidase and parent mycelial microorganism Mortierella vinaceae var. raffinoseutilizer may be safely used in food in accord ance 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 microorga nism matches American Type Culture Collection (ATCC) No. 20034, 1 and is classified as follows: Class: Phycomycetes. Order: Mucorales. Family: Mortierellaceae. Genus: Mortierella. Species: vinaceae. Variety: raffinoseutilizer. (c) The additive is used or intended for use in the production of sugar (su crose) from sugar beets by addition as VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00145 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 136 21 CFR Ch. I (4–1–16 Edition) § 173.150 1 Available from: American Type Culture Collection, 12301 Parklawn Drive, Rockville, MD 20852. mycelial pellets to the molasses to in crease 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 resi dues remaining in the finished sucrose. [42 FR 14526, Mar. 15, 1977, as amended at 54 FR 24897, June 12, 1989] § 173.150 Milk-clotting enzymes, micro bial. Milk-clotting enzyme produced by pure-culture fermentation process may be safely used in the production of cheese in accordance with the fol lowing 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 fol lows: 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; fam ily, 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 re combinant deoxyribonucleic (DNA) techniques to contain the gene coding for aspartic proteinase from Rhizomucor miehei var. Cooney et Emer son as defined in paragraph (a)(4) of this section, and classified as follows: Class, Blastodeuteromycetes (Hyphomycetes); order, Phialidales (Moniliales); genus, Aspergillus; species oryzae. (b) The strains of organism identified in paragraph (a) of this section are nonpathogenic and nontoxic in man or other animals. (c) The additive is produced by a process that completely removes the generating organism from the milk clotting enzyme product. (d) The additive is used in an amount not in excess of the minimum required to produce its intended effect in the production of those cheeses for which it is permitted by standards of identity established pursuant to section 401 of the Act. [42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 62 FR 59284, Nov. 3, 1997] § 173.160 Candida guilliermondii. The food additive Candida guilliermondii may be safely used as the organism for fermentation production of citric acid in accordance with the following conditions: (a) The food additive is the enzyme system of the viable organism Candida guilliermondii and its concomitant me tabolites produced during the fer mentation process. (b)(1) The nonpathogenic and nontoxicogenic organism descending from strain, American Type Culture Collection (ATCC) No. 20474, 1 is classi fied as follows: Class: Deuteromycetes. Order: Moniliales. Family: Cryptococcaceae. Genus: Candida. Species: guilliermondii. Variety: guilliermondii. (2) The toxonomic characteristics of the reference culture strain ATCC No. 20474 agree in the essentials with the standard description for Candida guilliermondii variety guilliermondii list ed in ‘‘The Yeasts—A Toxonomic Study;’’ 2d Ed. (1970), by Jacomina Lodder, which is incorporated by ref erence. Copies are available from the Center for Food Safety and Applied Nu trition (HFS–200), Food and Drug Ad ministration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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/ federallregister/ codeloflfederallregulations/ ibrllocations.html. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00146 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 137 Food and Drug Administration, HHS § 173.165 (c)(1) The additive is used or intended for use as a pure culture in the fer mentation process for the production of citric acid using an acceptable aque ous carbohydrate substrate. (2) The organism Candida quilliermondii is made nonviable and is completely removed from the citric acid during the recovery and purifi cation 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 Di rector of the Office of the Federal Reg ister approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may ob tain 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 Food and Drug Administration’s Main Li brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030 or go to: http:// www.archives.gov/federal-register/cfr/ibr locations.html. [42 FR 14526, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 78 FR 71466, Nov. 29, 2013] § 173.165 Candida lipolytica. The food additive Candida lipolytica may be safely used as the organism for fermentation production of citric acid in accordance with the following condi tions: (a) The food additive is the enzyme system of the organism Candida lipolytica and its concimitant metabo lites produced during the fermentation process. (b)(1) The nonpathogenic organism is classified as follows: Class: Deuteromycetes. Order: Moniliales. Family: Cryptococcaceae. Genus: Candida. Species: lipolytica. (2) The taxonomic characteristics of the culture agree in essential with the standard description for Candida lipolytica variety lipolytica listed in ‘‘The Yeasts—A Toxonomic Study,’’ 2d Ed. (1970), by Jacomina Lodder, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the National Archives and Records Ad ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (c) The additive is used or intended for use as a pure culture in the fer mentation 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 Di rector of the Office of the Federal Reg ister approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may ob tain 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 Food and Drug Administration’s Main Li brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar chives and Records Administration (NARA). For information on the avail ability 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 proce dure described in this paragraph: Ultraviolet absorbance per centimeter path length Maximum 280 to 289 millimicrons ....................................... 0.25 290 to 299 millimicrons ....................................... 0.20 300 to 359 millimicrons ....................................... 0.13 360 to 400 millimicrons ....................................... 0.03 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00147 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 138 21 CFR Ch. I (4–1–16 Edition) § 173.165 ANALYTICAL PROCEDURE FOR CITRIC ACID GENERAL INSTRUCTIONS Because of the sensitivity of the test, the possibility of errors arising from contamina tion 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 pre cautionary measure it is recommended prac tice to rinse all glassware with purified iso octane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of citric acid sam ples in handling is essential to assure ab sence of any extraneous material arising from inadequate packaging. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light. APPARATUS 1. Aluminum foil, oil free. 2. Separatory funnels, 500-milliliter capac ity, equipped with tetrafluoroethylene poly mer stopcocks. 3. Chromatographic tubes: (a) 80-milli meter ID × 900-millimeter length equipped with tetrafluoroethylene polymer stopcock and course fritted disk; (b) 18-millimeter ID × 300-millimeter length equipped with tetra fluoroethylene 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 oper ating conditions for these absorbance meas urements, the spectrophotometer shall also meet the following performance require ments: Absorbance repeatability, ±0.01 at 0.4 ab sorbance. 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 ca pacity. 6. Vacuum oven, minimum inside dimen sions: 200 mm × 200 mm × 300 mm deep. REAGENTS AND MATERIALS Organic solvents. All solvents used through out the procedure shall meet the specifica tions and tests described in this specifica tion. 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 con taining 0.5 milliliter of purified n-hexa decane and evaporated on the rotary evapo rator at 45 °C to constant volume. Six milli liters of purified isooctane are added to this residue and evaporated under the same con ditions as above for 5 minutes. Determine the absorbance of the residue compared to purified n-hexadecane as reference. The ab sorbance of the solution of the solvent res idue 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 pre ceding paragraph. If necessary, methyl alco hol may be purified by distillation through a Virgreaux column discarding the first and last ten percent of the distillate or other wise. Benzene, spectrograde (Burdick and Jackson Laboratories, Inc., Muskegon, Mich., or equiva lent). Use 80 milliliters for the test. If nec essary, benzene may be purified by distilla tion or otherwise. Isooctane (2,2,4-trimethylpentane). Use 100 milliliters for the test. If necessary, iso octane 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 equiva lent). Use 100 milliliters for the test. If nec essary, hexane may be purified by distilla tion 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 puri fied by distillation or otherwise. ELUTING MIXTURES 1. 10 percent 1,2-dichloroethane in hexane. Prepare by mixing the purified solvents in the volume ratio of 1 part of 1,2 dichloroethane to 9 parts of hexane. 2. 40 percent benzene in hexane. Prepare by mixing the purified solvents in the volume ratio of 4 parts of benzene to 6 parts of hexane. n-Hexadecane, 99 percent olefin-free. Deter mine 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-hexa decane 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 sili ca 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00148 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 139 Food and Drug Administration, HHS § 173.165 water and wash with 3,600 milliliters of puri fied 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. Acti vate in a vacuum oven at low vacuum (ap proximately 750 millimeters Mercury or 27 inches of Mercury below atmospheric pres sure) 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 chap ter. Water, purified. All water used must meet the specifications of the following test: Extract 600 milliliters of water with 50 mil liliters of purified isooctane. Add 1 milliliter of purified n-hexadecane to the isooctane ex tract 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 puri fied by distillation, extraction with purified organic solvents, treatment with an absorb ent (e.g., activated carbon) followed by fil tration of the absorbent or otherwise. PROCEDURE Separate portions of 200 milliliters of puri fied 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 mil liliter 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 iso octane and add the isooctane to the sepa ratory funnel. Gently shake the mixture 90 times (caution: vigorous shaking will cause emulsions) with periodic release of the pres sure 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 ali quot of 50 milliliters of isooctane. After sep aration of the layers, draw off and discard the water layer. Combine both isooctane ex tracts in the funnel containing the first ex tract. Rinse the funnel which contained the second extract with 10 milliliters of iso octane 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 in side of the column with 10 milliliters of puri fied isooctane. Drain the isooctane from the column. Pour 5.5 grams of activated silica gel into the column. Tap the column ap proximately 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 milli liters 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 milli liters of isooctane followed by 10 milliliters of a 10-percent dichloroethane in hexane so lution. For each rinse solution, drain the col umn 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 ben zene 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 evapo rator 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 iso octane 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-hexa decane as reference. Correct the absorbance values for any absorbance derived from the control reagent blank. If the corrected ab sorbance does not exceed the limits pre scribed, the samples meet the ultraviolet ab sorbance 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 be tween 280 and 299 nanometers, 0.02 absorb ance per centimeter path length between 300 and 359 nanometers, and 0.01 absorbance per centimeter path length between 360 and 400 nanometers. [42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 78 FR 71466, Nov. 29, 2013] VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00149 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 140 21 CFR Ch. I (4–1–16 Edition) § 173.170 § 173.170 Aminoglycoside 3′-phospho transferase II. The food additive aminoglycoside 3′ phosphotransferase II may be safely used in the development of genetically modified cotton, oilseed rape, and to matoes in accordance with the fol lowing prescribed conditions: (a) The food additive is the enzyme aminoglycoside 3′-phosphotransferase II (CAS Reg. No. 58943–39–8) which cata lyzes the phosphorylation of certain aminoglycoside antibiotics, including kanamycin, neomycin, and gentamicin. (b) Aminoglycoside 3′-phosphotrans ferase II is encoded by the kanr gene originally isolated from transposon Tn5 of the bacterium Escherichia coli. (c) The level of the additive does not exceed the amount reasonably required for selection of plant cells carrying the kanr gene along with the genetic mate rial of interest. [59 FR 26711, May 23, 1994] Subpart C—Solvents, Lubricants, Release Agents and Related Substances § 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 accord ance with the following prescribed con ditions: (a) The substance meets the fol lowing 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 ex cept 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 accord ance with the following conditions: (a) The additive meets the specifica tions of the Food Chemicals Codex, 7th ed. (2010), pp. 343–344, which is incor porated by reference. The Director of the Office of the Federal Register ap proves 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 ex amined at the Food and Drug Adminis tration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For informa tion on the availability of this mate rial 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 prac tice as a solvent in the decaffeination of coffee and tea. [47 FR 146, Jan. 5, 1982, as amended at 49 FR 28548, July 13, 1984; 78 FR 71466, Nov. 29, 2013] § 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 resi dues 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 condi tions 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 pro duction of the oil, at a level not to ex ceed 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, VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00150 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 141 Food and Drug Administration, HHS § 173.280 (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 alco hol and provides for the use of the hops extract only as prescribed by para graph (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; Pro vided, That, if residues of other chlorinated solvents are also present, the total of all residues of such sol vents shall not exceed 30 parts per mil lion. (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 iden tifies 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 caf feine 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 ex tract (instant coffee). § 173.270 Hexane. Hexane may be present in the fol lowing foods under the conditions spec ified: (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 ex tract 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 accord ance with the following prescribed con ditions: (a) The sperm oil is derived from ren dering 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 bak ery 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 re covery 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 chap ter, and tridodecyl amine. (b) The component substances are used solely as a solvent mixture and in a manner that does not result in for mation of products not present in con ventionally produced citric acid. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00151 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 142 21 CFR Ch. I (4–1–16 Edition) § 173.290 (c) The citric acid so produced meets the polynuclear aromatic hydrocarbon specifications of § 173.165 and the speci fications of the Food Chemicals Codex, 7th ed. (2010), pp. 226–227, which is in corporated by reference. The Director of the Office of the Federal Register approves this incorporation by ref erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may ob tain 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 Food and Drug Administration’s Main Li brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar chives and Records Administration (NARA). For information on the avail ability 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 hy drocarbons are removed in accordance with good manufacturing practice. Cur rent good manufacturing practice re sults in residues not exceeding 16 parts per million (ppm) n-octyl alcohol and 0.47 ppm synthetic isoparaffinic petro leum hydrocarbons in citric acid. (e) Tridodecyl amine may be present as a residue in citric acid at a level not to exceed 100 parts per billion. [42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10106, Mar. 19, 1984; 78 FR 71466, Nov. 29, 2013] § 173.290 Trichloroethylene. Tolerances are established for resi dues of trichloroethylene resulting from its use as a solvent in the manu facture of foods as follows: Decaffeinated ground coffee 25 parts per million. Decaffeinated soluble (in stant) coffee extract. 10 parts per million. Spice oleoresins .................... 30 parts per million (provided that if residues of other chlorinated solvents are also present, the total of all residues of such solvents in spice oleoresins shall not exceed 30 parts per million). Subpart D—Specific Usage Additives § 173.300 Chlorine dioxide. Chlorine dioxide (CAS Reg. No. 10049– 04–4) may be safely used in food in ac cordance 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 hypo chlorite and hydrochloric acid. (ii) Treating an aqueous solution of sodium chlorate with hydrogen per oxide 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 spe cies as determined by Method 4500–ClO2 E in the ‘‘Standard Methods for the Ex amination of Water and Wastewater,’’ 20th ed., 1998, or an equivalent method. Method 4500–ClO2 E (‘‘Amperometric Method II’’) is incorporated by ref erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may ob tain a copy from the Office of Food Ad ditive Safety (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or the American Public Health Association, 800 I St. NW., Washington, DC 20001–3750. You may inspect a copy at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.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) resid ual chlorine dioxide as determined by Method 4500–ClO2 E, referenced in para graph (a)(2) of this section, or an equiv alent method. (2) The additive may be used as an antimicrobial agent in water used to VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00152 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 143 Food and Drug Administration, HHS § 173.310 wash fruits and vegetables that are not raw agricultural commodities in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500–ClO2 E, referenced in para graph (a)(2) of this section, or an equiv alent method. Treatment of the fruits and vegetables with chlorine dioxide shall be followed by a potable water rinse or by blanching, cooking, or can ning. [60 FR 11900, Mar. 3, 1995. Redesignated at 61 FR 14245, Apr. 1, 1996, as amended at 61 FR 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; 65 FR 34587, May 31, 2000; 70 FR 7396, Feb. 14, 2005; 81 FR 5592, Feb. 3, 2016] § 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 func tional purpose, and the amount of steam in contact with food does not ex ceed that required to produce the in tended effect in or on the food. (b) The compounds are prepared from substances identified in paragraphs (c) and (d) of this section, and are subject to the limitations, if any, prescribed: (c) List of substances: Substances Limitations Acrylamide-sodium acrylate resin ................................................. Contains not more than 0.05 percent by weight of acrylamide monomer. Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copoly mer having a minimum weight average molecular weight of 9,900 and a minimum number average molecular weight of 5,700 as determined by a method entitled ‘‘Determination of Weight Average and Number Average Molecular Weight of 60/40 AA/AMPS’’. Total not to exceed 20 parts per million (active) in boiler feedwater. Ammonium alginate. Cobalt sulfate (as catalyst). 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809–21–4) and its sodium and potassium salts. Lignosulfonic acid. Monobutyl ethers of polyethylene-polypropylene glycol produced by random condensation of a 1:1 mixture by weight of ethyl ene oxide and propylene oxide with butanol. Minimum mol. wt. 1,500. Poly(acrylic acid-co-hypophosphite), sodium salt (CAS Reg. No. 71050–62–9), produced from a 4:1 to a 16:1 mixture by weight of acrylic acid and sodium hypophosphite. Total not to exceed 1.5 parts per million in boiler feed water. Copolymer contains not more than 0.5 percent by weight of acrylic acid monomer (dry weight basis). Polyethylene glycol ....................................................................... As defined in § 172.820 of this chapter. Polymaleic acid [CAS Reg. No. 26099–09–2], and/or its sodium salt. [CAS Reg. No. 30915–61–8 or CAS Reg. No. 70247– 90–4]. Total not to exceed 1 part per million in boiler feed water (cal culated as the acid). Polyoxypropylene glycol ............................................................... Minimum mol. wt. 1,000. Potassium carbonate. Potassium tripolyphosphate. Sodium acetate. Sodium alginate. Sodium aluminate. Sodium carbonate. Sodium carboxymethylcellulose ................................................... Contains not less than 95 percent sodium carboxymethylcellulose on a dry-weight basis, with max imum substitution of 0.9 carboxymethylcellulose groups per anhydroglucose unit, and with a minimum viscosity of 15 centipoises for 2 percent by weight aqueous solution at 25 °C; by the ‘‘Viscosity of Cellulose Gum’’ method prescribed in the Food Chemicals Codex, pp. 1128–1129. Sodium glucoheptonate ................................................................ Less than 1 part per million cyanide in the sodium glucoheptonate. Sodium hexametaphosphate. Sodium humate. Sodium hydroxide. Sodium lignosulfonate. Sodium metabisulfite. Sodium metasilicate. Sodium nitrate. Sodium phosphate (mono-, di-, tri-). Sodium polyacrylate. Sodium polymethacrylate. Sodium silicate. Sodium sulfate. Sodium sulfite (neutral or alkaline). VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00153 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 144 21 CFR Ch. I (4–1–16 Edition) § 173.315 Substances Limitations Sodium tripolyphosphate. Sorbitol anhydride esters: A mixture consisting of sorbitan monostearate as defined in § 172.842 of this chapter; poly sorbate 60 ((polyoxyethylene (20) sorbitan monostearate)) as defined in § 172.836 of this chapter; and polysorbate 20 ((polyoxyethylene (20) sorbitan monolaurate)), meeting the specifications of the Food Chemicals Codex, pp. 825–827.. The mixture is used as an anticorrosive agent in steam boiler distribution systems, with each component not to exceed 15 milligrams per kilogram in the steam. Tannin (including quebracho extract). Tetrasodium EDTA. Tetrasodium pyrophosphate. (d) Substances used alone or in com bination with substances in paragraph (c) of this section: Substances Limitations Cyclohexylamine ............................................ Not to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Diethylaminoethanol ....................................... Not to exceed 15 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Hydrazine ....................................................... Zero in steam. Morpholine ...................................................... Not to exceed 10 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Octadecylamine .............................................. Not to exceed 3 parts per million in steam, and excluding use of such steam in contact with milk and milk products. Trisodium nitrilotriacetate ............................... Not to exceed 5 parts per million in boiler feedwater; not to be used where steam will be in contact with milk and milk products. (e) To assure safe use of the additive, in addition to the other information re quired 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 as sure compliance with all the provisions of this section. (f) The standards required in this sec tion 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. Cop ies may be examined at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030 or go to: http:// www.archives.gov/federal-register/cfr/ibr locations.html. (1) FDA Main Library, 10903 New Hampshire Ave., Silver Spring, MD 20993: (i) ‘‘Determination of Weight Aver age and Number Average Molecular Weight of 60/40 AA/AMPS’’ (October 23, 1987). (ii) [Reserved] (2) United States Pharmacopeial Con vention, 12601 Twinbrook Pkwy., Rock ville, 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. [42 FR 14526, Mar. 15, 1977, as amended at 45 FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990; 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, 1999; 64 FR 29227, June 1, 1999; 78 FR 71466, Nov. 29, 2013] § 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: VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00154 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 145 Food and Drug Administration, HHS § 173.315 (1) Substances generally recognized as safe in food or covered by prior sanc tions for use in washing fruits and vegetables. (2) Substances identified in this sub paragraph and subject to such limita tions as are provided: Substances Limitations A mixture of alkylene oxide adducts of alkyl alcohols and phosphate esters of alkylene oxide adducts of alkyl alcohols consisting of: a-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (7.5–8.5 moles)/poly (oxypropylene) block copolymer having an average molecular weight of 810; a-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (3.3–3.7 moles) polymer having an average molecular weight of 380, and sub sequently esterified with 1.25 moles phosphoric anhydride; and a-alkyl (C10-C12)-omega-hydroxypoly (oxyethylene) (11.9–12.9 moles)/poly (oxypropylene) copolymer, having an average molecular weight of 810, and subsequently esterified with 1.25 moles phosphoric anhy dride. May be used at a level not to exceed 0.2 percent in lye-peeling solution to assist in the lye peeling of fruit and vegetables. Aliphatic acid mixture consisting of valeric, caproic, enanthic, caprylic, and pelargonic acids. May be used at a level not to exceed 1 percent in lye peeling solution to assist in the lye peeling of fruits and vegetables. Polyacrylamide ............................................................................................ Not to exceed 10 parts per million in wash water. Contains not more than 0.2 percent acrylamide monomer. May be used in the washing of fruits and vegetables. Potassium bromide ..................................................................................... May be used in the washing or to assist in the lye peeling of fruits and vegetables. Sodium n-alkylbenzene-sulfonate (alkyl group predominantly C12 and C13 and not less than 95 percent C10 to C16). Not to exceed 0.2 percent in wash water. May be used in washing or to assist in the lye peeling of fruits and vegetables. Sodium dodecylbenzene-sulfonate (alkyl group predominantly C12 and not less than 95% C10 to C16). Do. Sodium 2 ethyl-hexyl sulfate ....................................................................... Do. Sodium hypochlorite .................................................................................... May be used in the washing or to assist in the lye peeling of fruits and vegetables. Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245–260) Not to exceed 0.2 percent in wash water. May be used in the washing or to assist in the lye peeling of fruits and vegetables. (3) Sodium mono- and dimethyl naph thalene 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 para graph (a)(4) for use in flume water for washing sugar beets prior to the slicing operation and subject to the limita tions as are provided for the level of the substances in the flume water: Substance Limitations a-Alkyl-omega-hydroxypoly-(oxy ethylene) produced by con densation of 1 mole of C11 C486315 straight chain ran domly substituted secondary al cohols with an average of 9 moles of ethylene oxide. Not to exceed 3 ppm. Linear undecylbenzenesulfonic acid. Do. Dialkanolamide produced by con densing 1 mole of methyl lau rate with 1.05 moles of diethanolamine. Not to exceed 2 ppm. Triethanolamine ............................ Do. Ethylene glycol monobutyl ether .. Not to exceed 1 ppm. Substance Limitations Oleic acid conforming with § 172.860 of this chapter. Do. Tetrapotassium pyrophosphate .... Not to exceed 0.3 ppm. Monoethanolamine ....................... Do. Ethylene dichloride ....................... Not to exceed 0.2 ppm. Tetrasodium ethylenediamine tetraacetate. Not to exceed 0.1 ppm. (5) Substances identified in this para graph (a)(5) for use on fruits and vege tables that are not raw agricultural commodities and subject to the limita tions provided: Substances Limitations Hydrogen peroxide ......... Used in combination with acetic acid to form peroxyacetic acid. Not to exceed 59 ppm in wash water. 1-Hydroxyethylidene-1,1 diphosphonic acid. May be used only with peroxy acetic acid. Not to exceed 4.8 ppm in wash water. Peroxyacetic acid ............ Prepared by reacting acetic acid with hydrogen peroxide. Not to exceed 80 ppm in wash water. (b) The chemicals are used in amounts not in excess of the minimum VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00155 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 146 21 CFR Ch. I (4–1–16 Edition) § 173.320 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 pota ble water to remove, to the extent pos sible, residues of the chemicals. (d) To assure safe use of the additive: (1) The label and labeling of the addi tive 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 addi tive container shall bear adequate use directions to assure use in compliance with all provisions of this section. [42 FR 14526, Mar. 15, 1977, as amended at 42 FR 29856, June 10, 1977; 42 FR 32229, June 24, 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; 64 FR 38564, July 19, 1999] § 173.320 Chemicals for controlling microorganisms in cane-sugar and beet-sugar mills. Agents for controlling microorga nisms 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 para graph (b) of this section. (b) They are applied to the sugar mill grinding, crusher, and/or diffuser sys tems 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 sec tion. Quantities of the individual addi tives in parts per million are expressed in terms of the weight of the raw cane or raw beets. (1) Combination for cane-sugar mills: Parts per mil lion Disodium cyanodithioimidocarbonate ........................ 2.5 Ethylenediamine ........................................................ 1.0 Potassium N-methyldithiocarbamate ......................... 3.5 (2) Combination for cane-sugar mills: Parts per mil lion Disodium ethylenebisdithiocarbamate ....................... 3.0 Sodium dimethyldithiocarbamate .............................. 3.0 (3) Combinations for cane-sugar mills and beet-sugar mills: Parts per mil lion (i) Disodium ethylenebisdithiocarbamate .................. 3.0 Ethylenediamine ........................................................ 2.0 Sodium dimethyldithiocarbamate .............................. 3.0 (ii) Disodium cyanodithioimidocarbonate ................... 2.9 Potassium N-methyldithiocarbamate ......................... 4.1 (4) Single additive for cane-sugar mills and beet-sugar mills. Parts per million 2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222–01–2). Limitations: By product molasses, bagasse, and pulp containing residues of 2,2-dibromo-3 nitrilopropionamide are not authorized for use in animal feed. Not more than 10.0 and not less than 2.0. (5) Combination for cane-sugar mills: Parts per mil lion n-Dodecyl dimethyl benzyl ammonium chlo ride ............................................................. 0.05±0.005 n-Dodecyl dimethyl ethylbenzyl ammonium chloride ....................................................... 0.68±0.068 n-Hexadecyl dimethyl benzyl ammonium chloride ....................................................... 0.30±0.030 n-Octadecyl dimethyl benzyl ammonium chloride ....................................................... 0.05±0.005 n-Tetradecyl dimethyl benzyl ammonium chloride ....................................................... 0.60±0.060 n-Tetradecyl dimethyl ethylbenzyl ammo nium chloride .............................................. 0.32±0.032 Limitations. Byproduct molasses, ba gasse, and pulp containing residues of these quaternary ammonium salts are not authorized for use in animal feed. (6) Single additive for beet-sugar mills: Parts per million Glutaraldehyde (CAS Reg. No. 111–30–8). Not more than 250. (c) To assure safe use of the addi tives, their label and labeling shall conform to that registered with the Environmental Protection Agency. [42 FR 14526, Mar. 15, 1977, as amended at 47 FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29, 1985; 57 FR 8065, Mar. 6, 1992] § 173.322 Chemicals used in delinting cottonseed. Chemicals may be safely used to as sist in the delinting of cottonseed in VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00156 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 147 Food and Drug Administration, HHS § 173.325 accordance with the following condi tions: (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 para graph and subject to such limitations as are provided: Substances Limitations alpha-Alkyl-omega hydroxypoly-(oxyethylene) produced by condensation of a linear primary alcohol containing an average chain length of 10 carbons with poly(oxyethylene) hav ing an average of 5 ethyl ene oxide units. May be used at an applica tion rate not to exceed 0.3 percent by weight of cot tonseeds to enhance delinting of cottonseeds in tended for the production of cottonseed oil. Byprod ucts including lint, hulls, and meal may be used in animal feed. An alkanomide produced by condensation of coconut oil fatty acids and dietha nolamine, CAS Reg. No. 068603–42–9. May be used at an applica tion rate not to exceed 0.2 percent by weight of cot tonseeds to enhance delinting of cottonseeds in tended for the production of cottonseed oil. Byprod ucts including lint, hulls, and meal may be used in animal feed. [47 FR 8346, Feb. 26, 1982] § 173.325 Acidified sodium chlorite so lutions. Acidified sodium chlorite solutions may be safely used in accordance with the following prescribed conditions: (a) The additive is produced by mix ing an aqueous solution of sodium chlo rite (CAS Reg. No. 7758–19–2) with any generally recognized as safe (GRAS) acid. (b)(1) The additive is used as an anti microbial agent in poultry processing water in accordance with current in dustry 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 car cass 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 ap plied to poultry meat, organs, or re lated parts or trim. (2) When used in a spray or dip solu tion, the additive is used at levels that result in sodium chlorite concentra tions 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 chill er solution, the additive is used at lev els that result in sodium chlorite con centrations 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 anti microbial agent in accordance with current industry practice in the proc essing 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 so lution pH of 2.5 to 2.9. (d)(1) The additive is used as an anti microbial agent in water and ice that are used to rinse, wash, thaw, trans port, or store seafood in accordance with current industry standards of good manufacturing practice. The addi tive 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 mil lion (ppm) sodium chlorite. Any sea food 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 ap plication in processing facilities as an antimicrobial agent to reduce patho genic bacteria due to cross-contamina tion during the harvesting, handling, heading, evisceration, butchering, stor ing, 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00157 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 148 21 CFR Ch. I (4–1–16 Edition) § 173.340 at levels that result in a sodium chlo rite concentration of 1,200 ppm, in com bination 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 anti microbial 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 ap plied 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 con centrations of 500 to 1200 parts per mil lion (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 can ning. (f) The additive is used as an anti microbial agent on processed, comminuted or formed meat food prod ucts (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 manufac turing practice. Applied as a dip or spray, the additive is used at levels that result in sodium chlorite con centrations of 500 to 1200 ppm, in com bination with any GRAS acid at levels sufficient to achieve a pH of 2.5 to 2.9. (g) The additive is used as an anti microbial agent in the water applied to processed fruits and processed root, tuber, bulb, legume, fruiting (i.e., egg plant, groundcherry, pepino, pepper, tomatillo, and tomato), and cucurbit vegetables in accordance with current industry standards of good manufac turing practices, as a component of a spray or dip solution, provided that such application be followed by a pota ble 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 vegeta bles) and vegetables in the Brassica [Cole] family, application must be by dip treatment only, and must be pre ceded by a potable water rinse and fol lowed by a potable water rinse and a 24-hour holding period prior to con sumption. When used in a spray or dip solution, the additive is used at levels that result in sodium chlorite con centrations 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 chlo rite is determined by a method entitled ‘‘Determination of Sodium Chlorite: 50 ppm to 1500 ppm Concentration,’’ Sep tember 13, 1995, developed by Alcide Corp., Redmond, WA, which is incor porated 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, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1200, or may be examined at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [61 FR 17829, Apr. 23, 1996, as amended at 63 FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13, 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR 22922, May 7, 2001; 66 FR 31841, June 13, 2001; 67 FR 15720, Apr. 3, 2002; 69 FR 78304, Dec. 30, 2004; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, 2016] § 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 para graph (a)(2) of this section, subject to any limitations imposed: VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00158 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 149 Food and Drug Administration, HHS § 173.340 Substances Limitations Dimethylpolysiloxane (substantially free from hydrolyzable chlo ride and alkoxy groups; no more than 18 percent loss in weight after heating 4 hours at 200 °C; viscosity 300 to 1,050 centistokes at 25 °C; refractive index 1.400–1.404 at 25 °C). 10 parts per million in food, or at such level in a concentrated food that when prepared as directed on the labels, the food in its ready-for-consumption state will have not more than 10 parts per million except as follows: Zero in milk; 110 parts per million in dry gelatin dessert mixes labeled for use whereby no more than 16 parts per million is present in the ready-to-serve dessert; 250 parts per million in salt labeled for cooking purposes, whereby no more than 10 parts per million is present in the cooked food. Formaldehyde ............................................................................... As a preservative in defoaming agents containing dimethylpolysiloxane, in an amount not exceeding 1.0 per cent of the dimethylpolysiloxane content. a-Hydro-omega-hydroxy-poly (oxyethylene)/poly(oxypropylene) (minimum 15 moles)/poly(oxyethylene) block copolymer (CAS Reg. No. 9003–11–6) as defined in § 172.808(a)(3) of this chapter. For use as prescribed in § 172.808(b)(3) of this chapter. Polyacrylic acid, sodium salt ........................................................ As a stabilizer and thickener in defoaming agents containing dimethylpolysiloxane in an amount reasonably required to accomplish the intended effect. Polyethylene glycol ....................................................................... As defined in § 172.820 of this chapter. Polyoxyethylene 40 monostearate ............................................... As defined in U.S.P. XVI. Polysorbate 60 .............................................................................. As defined in § 172.836 of this chapter. Polysorbate 65 .............................................................................. As defined in § 172.838 of this chapter. Propylene glycol alginate .............................................................. As defined in § 172.858 of this chapter. Silicon dioxide ............................................................................... As defined in § 172.480 of this chapter. Sorbitan monostearate ................................................................. As defined in § 172.842 of this chapter. White mineral oil: Conforming with § 172.878 of this chapter ...... As a component of defoaming agents for use in wash water for sliced potatoes at a level not to exceed 0.008 percent of the wash water. (3) Substances listed in this para graph (a)(3), provided they are compo nents of defoaming agents limited to use in processing beet sugar and yeast, and subject to any limitations im posed: Substances Limitations Aluminum stearate ...................................................................................... As defined in § 172.863 of this chapter. Butyl stearate. BHA ............................................................................................................. As an antioxidant, not to exceed 0.1 percent by weight of defoamer. BHT ............................................................................................................. Do. Calcium stearate ......................................................................................... As defined in § 172.863 of this chapter. Fatty acids ................................................................................................... As defined in § 172.860 of this chapter. Formaldehyde ............................................................................................. As a preservative. Hydroxylated lecithin ................................................................................... As defined in § 172.814 of this chapter. Isopropyl alcohol. Magnesium stearate .................................................................................... As defined in § 172.863 of this chapter. Mineral oil: Conforming with § 172.878 of this chapter .............................. Not more than 150 p.p.m. in yeast, measured as hy drocarbons. Odorless light petroleum hydrocarbons: Conforming with § 172.884 of this chapter. Petrolatum: Conforming with § 172.880 of this chapter .............................. Petroleum wax: Conforming with § 172.886 of this chapter. Petroleum wax, synthetic. Polyethylene glycol (400)dioleate: Conforming with § 172.820(a)(2) of this chapter and providing the oleic acid used in the production of this substance complies with § 172.860 or § 172.862 of this chapter. As an emulsifier not to exceed 10 percent by weight of defoamer formulation. Synthetic isoparaffinic petroleum hydrocarbons: Conforming with § 172.882 of this chapter. Oleic acid derived from tall oil fatty acids ................................................... Complying with § 172.862 of this chapter. Oxystearin ................................................................................................... As defined in § 172.818 of this chapter. Polyoxyethylene (600) dioleate. Polyoxyethylene (600) monoricinoleate. Polypropylene glycol ................................................................................... Molecular weight range, 1,200–3,000. Polysorbate 80 ............................................................................................ As defined in § 172.840 of this chapter. Potassium stearate ..................................................................................... As defined in § 172.863 of this chapter. Propylene glycol mono- and diesters of fats and fatty acids ..................... As defined in § 172.856 of this chapter. Soybean oil fatty acids, hydroxylated. Tallow, hydrogenated, oxidized or sulfated. Tallow alcohol, hydrogenated. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00159 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 150 21 CFR Ch. I (4–1–16 Edition) § 173.342 (4) The substances listed in this para graph (a)(4), provided they are compo nents of defoaming agents limited to use in processing beet sugar only, and subject to the limitations imposed: Substances Limitations n-Butoxypoly(oxyethylene) poly(oxypropylene)glycol. Viscosity range, 4,850–5,350 Saybolt Universal Seconds (SUS) at 37.8 °C (100 °F). The viscosity range is de termined by the method ‘‘Viscosity Determination of n-butoxypoly(oxyethylene) poly(oxypropylene) glycol’’ dated April 26, 1995, de veloped by Union Carbide Corp., P.O. Box 670, Bound Brook, NJ 08805, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the material incorporated by reference are available from the Office of Food Ad ditive Safety (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., Col lege Park, MD 20740, and may be examined at the Food and Drug Administra tion’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301– 796–2039, or at the Na tional Archives and Records Administration (NARA). For information on the availability of this mate rial at NARA, call 202– 741–6030, or go to: http:// www.archives.gov/ federallregister/ codeloflfederall regu lations/ibrllocations.html. Monoester of alpha-hydro omega-hydroxy poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole minimum) blocked copoly mer derived from low eru cic acid rapeseed oil. (b) They are added in an amount not in excess of that reasonably required to inhibit foaming. [42 FR 14526, Mar. 15, 1977, as amended at 43 FR 2872, Jan. 20, 1978; 46 FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR 29134, May 28, 1998; 81 FR 5592, Feb. 3, 2016] § 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 condi tions: (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 com posed of substances regulated in parts 174, 175, 177, 178, and § 179.45 of this chapter and conforming to any limita tions or specifications in such regula tions. [55 FR 8913, Mar. 9, 1990] § 173.345 Chloropentafluoroethane. The food additive chloropentafluoroethane may be safely used in food in accordance with the fol lowing prescribed conditions: (a) The food additive has a purity of not less than 99.97 percent, and con tains not more than 200 parts per mil lion 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 nec essary to achieve the aerating func tion, 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 con tainer 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’’. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00160 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 151 Food and Drug Administration, HHS § 173.350 (2) The label or labeling of the food additive container shall bear adequate directions for use. [42 FR 14526, Mar. 15, 1977, as amended at 43 FR 11317, Mar. 17, 1978; 43 FR 14644, Apr. 7, 1978] § 173.350 Combustion product gas. The food additive combustion prod uct gas may be safely used in the proc essing and packaging of the foods des ignated in paragraph (c) of this section for the purpose of removing and dis placing 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 pro vided with an absorption-type filter ca pable of removing possible toxic impu rities, 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 fol lowing specifications: (1) Carbon monoxide content not to exceed 4.5 percent by volume. (2) The ultraviolet absorbance in iso octane solution in the range 255 milli microns to 310 millimicrons not to ex ceed one-third of the standard ref erence absorbance when tested as de scribed in paragraph (e) of this section. (c) It is used or intended for use to displace or remove oxygen in the proc essing, storage, or packaging of bev erage products and other food, except fresh meats. (d) To assure safe use of the additive in addition to the other information re quired 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 para graph (b) of this section, including in structions to assure proper filtration. (e) The food additive is tested for compliance with paragraph (b)(2) by the following empirical method: Spectrophotometric measurements. All meas urements are made in an ultraviolet spectro photometer in optical cells of 5 centimeters in length, and in the range of 255 milli microns to 310 millimicrons, under the same instrumental conditions. The standard ref erence absorbance is the absorbance at 275 millimicrons of a standard reference solution of naphthalene (National Bureau of Stand ards 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 iso octane having an ultraviolet absorbance not to exceed 0.05 measured against distilled water as a reference. Upon passage of puri fied inert gas through some isooctane under the identical conditions of the test, a low ering of the absorbance value has been ob served. 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-centi meter cell. If necessary to obtain the pre scribed purities, the isooctane may be passed through activated silica gel. Apparatus. To assure reproducible results, the additive is passed into the isooctane so lution through a gas-absorption train con sisting of the following components and nec essary connections: 1. A gas flow meter with a range up to 30 liters per hour provided with a constant dif ferential 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 bot tom 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 51⁄4 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 de signed, 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 ab sorption vessel at least to the solvent level mark. Caution. The various parts of the absorp tion 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 absorp tion apparatus in that order. Ventilation should be provided for the effluent gases which may contain carbon monoxide. Sampling procedure. Immerse the gas-ab sorption apparatus containing 60 milliliters VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00161 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 152 21 CFR Ch. I (4–1–16 Edition) § 173.355 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, dis connect, 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 milli microns to 310 millimicrons, inclusive, com pared to isooctane. The absorbance of the so lution 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 ab sorbance. § 173.355 Dichlorodifluoromethane. The food additive dichlorodi fluoromethane 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 informa tion required by the act, the following: (i) The name of the additive, dichlo rodifluoromethane, 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 specifica tions of the Food Chemicals Codex, 7th ed. (2010), pp. 496 and 497, which is in corporated by reference. The Director of the Federal Register approves this incorporation by reference in accord ance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Con vention, 12601 Twinbrook Pkwy., Rock ville, MD 20852 (Internet address http:// www.usp.org). Copies may be examined at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (b) The additive is used as an anti microbial agent in the production of modified whey (including, but not lim ited 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. [76 FR 11330, Mar. 2, 2011, as amended at 81 FR 5592, Feb. 3, 2016] § 173.357 Materials used as fixing agents in the immobilization of en zyme preparations. Fixing agents may be safely used in the immobilization of enzyme prepara tions 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 sub paragraph and subject to such limita tions as are provided: Substances Limitations Acrylamide-acrylic acid resin: Complying with § 173.5(a)(1) and (b) of this chapter. May be used as a fixing material in the immobilization of glucose isomerase en zyme preparations for use in the manufacture of high fructose corn syrup, in ac cordance with § 184.1372 of this chapter. Cellulose triacetate ..................................... May be used as a fixing material in the immobilization of lactase for use in reducing the lactose content of milk. Diethylaminoethyl-cellulose ........................ May be used as a fixing material in the immobilization of glucose isomerase en zyme preparations for use in the manufacture of high fructose corn syrup, in ac cordance with § 184.1372 of this chapter. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00162 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 153 Food and Drug Administration, HHS § 173.368 Substances Limitations Dimethylamine-epichlorohydrin resin: Complying with § 173.60(a) and (b) of this chapter. May be used as a fixing material in the immobilization of glucose isomerase en zyme preparations for use in the manufacture of high fructose corn syrup, in ac cordance with § 184.1372 of this chapter. Glutaraldehyde ........................................... Do. Periodic acid (CAS Reg. No. 10450–60– 9).. Polyethylenimine reaction product with 1,2-dichloroethane (CAS Reg. No. 68130–97–2) is the reaction product of homopolymerization of ethylenimine in aqueous hydrochloric acid at 100 °C and of cross-linking with 1,2 dichloroethane. The finished polymer has an average molecular weight of 50,000 to 70,000 as determined by gel permeation chromatography. The analyt ical method is entitled ‘‘Methodology for Molecular Weight Detection of Polyethylenimine,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Cop ies may be obtained from the Office of Food Additive Safety (HFS–200), Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, and may be examined at the Food and Drug Administration’s Main Li brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the Na tional Archives and Records Administra tion (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. May be used as a fixing material in the immobilization of glucoamylase enzyme preparations from Aspergillus niger for use in the manufacture of beer. May be used as a fixing material in the immobilization of: 1. Glucose isomerase enzyme preparations for use in the manufacture of high fruc tose corn syrup, in accordance with § 184.1372 of this chapter. 2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manu facture of beer. Residual ethylenimine in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography-mass spectrometry. The residual ethylenimine is determined by an analytical method entitled ‘‘Methodology for Ethylenimine Detection in Polyethylenimine,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography. The residual 1,2 dichloroethane is determined by an analytical method entitled, ‘‘Methodology for Ethylenedichloride Detection in Polyethylenimine,’’ which is incorporated by ref erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Food Additive Safety (HFS–200), Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796– 2039, or at the National Archives and Records Administration (NARA). For infor mation on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federallregister/codeloflfederallregulations/ ibrllocations.html. (b) The fixed enzyme preparation is washed to remove residues of the fixing materials. [48 FR 5716, Feb. 8, 1983, as amended at 52 FR 39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990; 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, 1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, June 25, 2002; 81 FR 5592, Feb. 3, 2016] § 173.360 Octafluorocyclobutane. The food additive octafluorocyclo-bu tane 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 fol lowing specifications: 99.99 percent octafluorocyclobutane. Less than 0.1 part per million fluoroolefins, calculated as perfluoroisobutylene. (b) The additive is used or intended for use alone or with one or more of the following substances: Carbon dioxide, nitrous oxide, and propane, as a propel lant 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 con tainer 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, stor age, 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: VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00163 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 154 21 CFR Ch. I (4–1–16 Edition) § 173.370 (a) The additive is an unstable, color less gas with a pungent, characteristic odor, which occurs freely in nature. It is produced commercially by passing electrical discharges or ionizing radi ation through air or oxygen. (b) The additive is used as an anti microbial agent as defined in § 170.3(o)(2) of this chapter. (c) The additive meets the specifica tions for ozone in the Food Chemicals Codex, 7th ed. (2010), pp. 754–755, which is incorporated by reference. The Di rector of the Office of the Federal Reg ister approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may ob tain 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 Food and Drug Administration’s Main Li brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar chives and Records Administration (NARA). For information on the avail ability 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 stand ards of identity in 9 CFR part 319 or 9 CFR part 381, subpart P), in the gas eous or aqueous phase in accordance with current industry standards of good manufacturing practice. (e) When used on raw agricultural commodities, the use is consistent with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) and not applied for use under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act. [66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002, as amended at 78 FR 14665, Mar. 7, 2013; 78 FR 71467, Nov. 29, 2013] § 173.370 Peroxyacids. Peroxyacids may be safely used in ac cordance with the following prescribed conditions: (a) The additive is a mixture of per oxyacetic acid, octanoic acid, acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1 hydroxyethylidene-1,1-diphosphonic acid. (b)(1) The additive is used as an anti microbial 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 anti microbial agent on poultry carcasses, poultry parts, and organs in accord ance 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 max imum concentration of hydrogen per oxide 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 ref erence. The concentration of 1 hydroxyethylidene-1,1-diphosphonic acid is determined by a method enti tled ‘‘Determination of 1 hydroxyethylidene-1,1-diphosphonic acid (HEDP) Peroxyacid/Peroxide-Con taining Solutions,’’ August 21, 2001, de veloped by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The Director of the Office of the Federal Register approves these incorporations by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of these methods from the Division of Petition Review, Center for Food Safety and Applied Nu trition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or you may examine a copy at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin istration (NARA). For information on the availability of this material at VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00164 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 155 Food and Drug Administration, HHS § 173.395 NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [65 FR 70660, Nov. 27, 2000, as amended at 66 FR 48208, Sept. 19, 2001; 67 FR 61784, Oct. 2, 2002; 81 FR 5593, Feb. 3, 2016] § 173.375 Cetylpyridinium chloride. Cetylpyridinium chloride (CAS Reg. No. 123–93–5) may be safely used in food in accordance with the following condi tions: (a) The additive meets the specifica tions of the United States Pharma copeia (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 in corporation 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., Rock ville, MD 20852, or you may examine a copy at the Food and Drug Administra tion’s Main Library, 10903 New Hamp shire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin istration (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 con centration 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 im mersion in a chiller, at a level not to exceed 0.3 gram cetylpyridinium chlo ride per pound of raw poultry carcass, provided that the additive is used in systems that collect and recycle solu tion that is not carried out of the sys tem with the treated poultry carcasses; or (2) As a liquid aqueous solution ap plied 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 ap plied to the poultry carcasses. The con centration 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. [72 FR 67576, Nov. 29, 2007, as amended at 76 FR 59248, Sept. 26, 2011; 81 FR 5593, Feb. 3, 2016] § 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 CF3SO3H (CAS Reg. No. 1493–13–6). The catalyst (Trifluoromethane sulfonic acid) may safely be used in the production of cocoa butter substitute from palm oil (1-palmitoyl-2-oleoyl-3-stearin) (see § 184.1259 of this chapter) in accordance with the following conditions: (a) The catalyst meets the following specifications: Appearance, Clear liquid. Color, Colorless to amber. Neutralization equivalent, 147–151. Water, 1 percent maximum. Fluoride ion, 0.03 percent maximum. Heavy metals (as Pb), 30 parts per million maximum. Arsenic (as As), 3 parts per million max imum. (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 aque ous phase. Final traces of catalyst are VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00165 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 156 21 CFR Ch. I (4–1–16 Edition) § 173.400 removed by washing batches of the product three times with an aqueous solution of 0.5 percent sodium bicar bonate. (d) No residual catalyst may remain in the product at a detection limit of 0.2 part per million fluoride as deter mined by the method described in ‘‘Of ficial Methods of Analysis of the Asso ciation of Official Analytical Chem ists,’’ sections 25.049–25.055, 13th Ed. (1980), which is incorporated by ref erence. 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 Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. [43 FR 54237, Nov. 11, 1978, as amended at 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005] § 173.400 Dimethyldialkylammonium chloride. Dimethyldialkylammonium chloride may be safely used in food in accord ance with the following prescribed con ditions: (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 chlo ride to form the quaternary ammonium compounds consisting primarily of dimethyldioctadecylammonium chlo ride and dimethyldihexadecyl ammonium 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, re duced, methylated, and subsequently reacted with methyl chloride to form the quaternary ammonium compound known as dimethyl(2-ethylhexyl) hy drogenated tallow ammonium chloride and consisting primarily of dimethyl(2 ethylhexyl)octadecylammonium chlo ride and dimethyl(2-ethyl hexyl)hexadecylammonium chloride. (b) The food additive described in paragraph (a)(1) of this section con tains not more than a total of 2 percent by weight of free amine and amine hy drochloride. The food additive de scribed in paragraph (a)(2) of this sec tion 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 Quater nary Ammonium Chlorides,’’ 2d print ing including additions and revisions 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and from the American Oil Chemists’ Soci ety, P.O. Box 5037, Station A, Cham paign, IL 61820, or available for inspec tion 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/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (c) The food additive is used as a de colorizing agent in the clarification of refinery sugar liquors under the fol lowing 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 mil lion 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 con tact with aqueous food. Excess non adsorbed 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 crys tallization shall not exceed 1 part per million of sugar as determined by a method entitled ‘‘Colorimetric Deter mination of Residual Quaternary Am monium Compounds (Arquad HTL8) in Sugar and Sugar Solutions,’’ June 13, VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00166 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 157 Food and Drug Administration, HHS § 174.5 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to other infor mation required by the Federal Food, Drug, and Cosmetic Act, adequate di rections to assure use in compliance with paragraph (c) of this section. [56 FR 42686, Aug. 29, 1991] § 173.405 Sodium dodecylbenzenesulfonate. Sodium dodecylbenzenesulfonate (CAS No. 25155–30–0) may be safely used in accordance with the following pre scribed 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 pre pared for or served directly to the con sumer. (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 Fed eral Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with the provisions of this section. [77 FR 71697, Dec. 4, 2012] PART 174—INDIRECT FOOD ADDITIVES: GENERAL Sec. 174.5 General provisions applicable to indi rect food additives. 174.6 Threshold of regulation for substances used in food-contact articles. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. § 174.5 General provisions applicable to indirect food additives. (a) Regulations prescribing condi tions under which food additive sub stances may be safely used predicate usage under conditions of good manu facturing practice. For the purpose of this part and parts 175, 176, and 177 of this chapter, good manufacturing prac tice shall be defined to include the fol lowing restrictions: (1) The quantity of any food additive substance that may be added to food as a result of use in articles that contact food shall not exceed, where no limits are specified, that which results from use of the substance in an amount not more than reasonably required to ac complish the intended physical or tech nical effect in the food-contact article; shall not exceed any prescribed limita tions; and shall not be intended to ac complish any physical or technical ef fect in the food itself, except as such may be permitted by regulations in parts 170 through 189 of this chapter. (2) Any substance used as a compo nent of articles that contact food shall be of a purity suitable for its intended use. (b) The existence in the subchapter B of a regulation prescribing safe condi tions for the use of a substance as an article or component of articles that contact food shall not be construed to relieve such use of the substance or ar ticle from compliance with any other provision of the Federal Food, Drug, and Cosmetic Act. For example, if a regulated food-packaging material were found on appropriate test to im part odor or taste to a specific food product such as to render it unfit with in the meaning of section 402(a)(3) of the Act, the regulation would not be construed to relieve such use from compliance with section 402(a)(3). VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00167 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R